Midline catheter placement device

Abstract

The present application relates to a midline catheter placement device. A catheter insertion device for positioning a catheter (particularly a midline catheter) and inserting it into a patient is provided. The insertion device includes an actuator assembly movable relative to a housing for disposing the catheter on a needle. The gradual movement of the actuator advances the catheter assembly including the catheter on the guide needle in stages. The indexing finger of the catheter assembly engages the actuator body during the distal advancement of the actuator and deflects as the actuator moves proximally. The device also includes a locking device such as a button, a collar, a slide or a tab, which allows the movement of the catheter relative to the needle, but prevents the catheter from advancing to the first stage of the gradual movement.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 888,946, filed on August 19, 2019, the entire contents of which are incorporated herein by reference. Technical Field

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

[0004] Midline catheters are commonly used for parenteral nutrition, intravenous ("IV") fluid replacement, and administration of analgesics and antibiotics. Midline catheters are inserted at the bedside using aseptic technique and can remain in place for several weeks. Insertion (venipuncture) can be performed above and below the antecubital fossa in the cephalic, basilic, or brachial veins. The catheter tip is advanced 3 inches to 8 inches, with the tip terminating below the axilla and proximal central vein.

[0005] The potential advantages of midline catheters are reduced frequency of repeated venipunctures for lab / restart, reduced incidence of catheter-related infections, extended implantation / retention duration, improved clinical outcomes, patient satisfaction, and associated cost savings. Placing the catheter tip in a vein of larger diameter (compared to a smaller vein) in the upper arm provides improved drug delivery therapy and hemodilution. Midline catheters can be used to infuse contrast media with higher flow rates, which is usually accomplished by central venous ("CV") catheters (such as peripherally inserted central venous catheters ("PICC") applications).

[0006] Existing midline catheter devices usually include an integral guidewire. After the needle enters the vein, the guidewire is pushed through the lumen of the needle and into the vein. An ultrasonic probe or imaging device is often used to position the needle in a desired position. The catheter is then pushed into the vein over the guidewire. The needle and guidewire are then removed and separated from the catheter that remains in place in the vein.

[0007] These existing devices usually require the guidewire to be fully deployed by moving the sliding member into a locked / stopped position. To advance the catheter, the user must put down the ultrasound probe and use both hands to advance the catheter and complete the final steps of the procedure. This results in a loss of visualization of the vein and positioning of the catheter relative to the vein.

[0008] Catheter placement and advancement depends on using one hand to hold the device in a static position while manipulating the catheter advancement mechanism with the other hand, without using ultrasound imaging to assist in proper placement of the catheter. Once the catheter is fully advanced, the user must reposition the ultrasound probe to reestablish the image and confirm proper placement of the catheter. The procedure requires a series of sequential steps and specialized training. The additional exchange of hand positions from the ultrasound probe to the device and back to the probe increases the complexity of the procedure and puts the success of proper placement of the catheter at risk.

[0009] Therefore, there is a need for a catheter placement device that streamlines the steps involved in catheter placement and utilizes one-handed operation while still providing the same functionality as current catheter placement devices. Summary of the invention

[0010] In short, embodiments disclosed herein relate to an extended indwelling peripheral IV catheter ("PIVC") device that provides a longer length of "mini midline" catheter. The catheter will be placed similar to a PIVC without the need for a guidewire and will require only one-handed operation. The placement will be performed under ultrasound imaging guidance and can access deeper vessels or facilitate difficult venous access ("DVA") procedures. For patients requiring mid-term / long-term IV therapy, the catheter will be able to successfully extend the indwelling time, for example, between 5 and 30 days.

[0011] The present invention discloses a catheter placement device, comprising: a shell; a needle extending from the distal end of the shell; a catheter assembly coaxially arranged on the needle, including a catheter supported by a catheter hub and a safety assembly, the safety assembly including a first indexing finger; and an actuator assembly configured to longitudinally transition between a first position and a second position, the actuator assembly including an actuator button extending through an elongated opening in the shell and an actuator body, the actuator body including a plurality of actuator abutments, wherein as the actuator assembly moves between the first position and the second position, the first indexing finger engages a first actuator abutment of the plurality of actuator abutments, and the actuator assembly advances the catheter assembly distally in a stepwise manner.

[0012] In some embodiments, the first indexing finger is integrally molded with the safety assembly to form a single structure, and the first indexing finger is configured to flexibly deform as the actuator body moves from the second position to the first position. The first indexing finger is supported by a collar and formed as a separate structure from the safety assembly, the collar is coupled to the safety assembly, and the first indexing finger is configured to flexibly deform as the actuator body moves from the second position to the first position. The housing includes a plurality of housing tabs that engage the safety assembly to prevent proximal movement of the safety assembly. The housing includes a plurality of housing supports that engage a second indexing finger extending from the safety assembly to prevent proximal movement of the second indexing finger.

[0013] In some embodiments, the actuator body includes a top wall, a first side wall and a second side wall defining a reverse passage, and the catheter assembly moves along the longitudinal axis through the reverse passage. One of the first side wall or the second side wall includes a plurality of notches, which define a plurality of actuator supports. One of the first side wall or the second side wall includes a plurality of apertures, which define a plurality of actuator supports. The housing includes a first door and a second door, both of which are arranged at the distal end of the housing and are configured to pivotally pass through a horizontal plane between an open position and a closed position. The housing includes a first housing half and a second housing half combined along a longitudinal vertical plane, the first door being hingedly connected to the first housing half, and the second door being hingedly connected to the second housing half.

[0014] In some embodiments, the housing includes a first hinged door, which is arranged at the distal end of the housing and is configured to pivotally pass through a vertical plane. The housing includes a first housing half and a second housing half combined along a longitudinal horizontal plane, and the first door is hingedly connected to the first housing half. In some embodiments, the catheter placement device further includes a locking device, which transitions between a locked position and an unlocked position, and the locked position allows the movement of the catheter relative to the needle and limits the distal advancement of the catheter assembly in a step-by-step manner. The movement of the catheter relative to the needle is limited to less than the longitudinal distance between the first actuator support and the second actuator support adjacent to the first actuator support. The movement of the catheter relative to the needle is limited to less than half of the longitudinal distance between the first actuator support and the second actuator support adjacent to the first actuator support. The movement of the catheter relative to the needle is limited to a distance between 1mm and 3mm.

[0015] In some embodiments, the locking device includes a locking button, the locking button including an engagement arm, the engagement arm having a first orifice defining a first diameter and a second orifice defining a second diameter, the second diameter being greater than the first diameter, the first orifice communicating with the second orifice to define a lock hole shape, the lock hole shape receiving the anchor portion of the safety component passing therethrough. The locking button transitions between a locked position and an unlocked position, the anchor portion being arranged in the first orifice in the locked position and in the second orifice in the unlocked position. The anchor portion includes a flange extending radially from the proximal end of the anchor portion, the flange defining a diameter greater than the first diameter and less than the second diameter, the flange abutting against the engagement arm when the locking button is in the locked position.

[0016] In some embodiments, locking device comprises locking collar, and it is slidably engaged with the outer surface of housing and longitudinally changes between locked position and unlocked position.The locking collar surrounds the longitudinal axis of housing, and the locking collar covers a part of elongated opening in locked position to limit the motion of actuator assembly.The locking collar is arranged between actuator button and first protrusion (protrusion) in locked position, and is arranged between first protrusion and second protrusion in unlocked position.The locking device comprises locking slide (slider), and it is arranged on actuator button, and slides perpendicular to longitudinal axis to engage breach when in locked position.The longitudinal width of slide is less than the longitudinal width of breach, to allow the motion of actuator button in locked position and limit the distal advancement of catheter assembly in a stepwise manner.

[0017] In some embodiments, the locking slide in the unlocked position is aligned with the actuator button to disengage the notch and allow the actuator assembly to move between the first position and the second position. The locking device includes a locking tab that is disposed between the actuator assembly and the housing in the locked position, limiting the movement of the actuator assembly. The locking tab extends through a slot in the housing, the tab defining a longitudinal width that is less than the longitudinal length of the slot.

[0018] A method for inserting a catheter is also disclosed, comprising: providing a catheter insertion device having a shell, a needle extending from a distal end of the shell, an actuator assembly including an actuator button and an actuator body, a catheter assembly coaxially arranged on the needle, and a locking device that can be transformed between a locked position and an unlocked position, the catheter assembly having a catheter supported by a catheter hub and a safety assembly, the locking device permitting movement of the catheter relative to the needle and inhibiting advancement of the catheter in a step-by-step manner; actuating the actuator button when the locking device is in the locked position to move the catheter relative to the needle; transforming the locking device from the locked position to the unlocked position; inserting the needle into a patient to access their vascular system; and actuating the actuator button from a first position to a second position to advance the catheter in a step-by-step manner relative to the needle.

[0019] In some embodiments, the actuator body includes a plurality of actuator supports, and the safety assembly includes an indexing finger that engages one of the plurality of actuator supports as the actuator button moves from a first position to a second position, and the indexing finger deflects as the actuator button moves from the second position to the first position.

[0020] A method for advancing a catheter over a needle is also disclosed, comprising: providing a catheter placement device comprising a housing, a catheter assembly, an actuator assembly, and a locking device, the housing comprising a plurality of housing tabs and a needle extending from a distal end of the housing, the catheter assembly comprising a catheter coaxially arranged on the needle and engaging a first housing tab of the plurality of housing tabs, the actuator assembly being configured to move between a first position and a second position to advance the catheter assembly from the first housing tab to a second housing tab adjacent to the first housing tab, the locking device being transitionable between a locked position and an unlocked position, the locked position restricting movement of the catheter assembly between the first housing tab and the second housing tab, the unlocked position permitting movement of the catheter assembly between the first housing tab and the second housing tab; actuating an actuator button with the locking device in the locked position to move the catheter relative to the needle while preventing the catheter assembly from being advanced from the first housing tab to the second housing tab; transitioning the locking device from the locked position to the unlocked position; inserting the needle into a patient to access their vascular system; and actuating the actuator button from the first position to the second position to advance the catheter assembly from the first housing tab to the second housing tab.

[0021] In some embodiments, the locking device is one of a locking button, a locking collar, a locking slide, and a locking tab.The housing includes a first hinged door and a second hinged door, each disposed at a distal end of the housing and configured to pivot to an open position to release the catheter hub. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] A more specific description of the present disclosure will be presented by reference to specific embodiments of the present disclosure shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the present invention and, therefore, should not be considered to limit the scope of the present invention. Example embodiments of the present invention will be described and explained with additional particularity and detail through the use of the accompanying drawings, in which:

[0023] Figure 1 A perspective view of a catheter insertion device according to embodiments disclosed herein is shown showing an actuator in a starting position.

[0024] Figure 2 The embodiment disclosed herein is shown Figure 1 A perspective view of a catheter insertion device showing the actuator in a forward actuated position.

[0025] Figure 3 The embodiment disclosed herein is shown Figure 1 A cross-sectional side view of a catheter insertion device showing the catheter and hub in a starting position and with an introducer needle extending from a distal end of the catheter insertion device.

[0026] Figures 4A to 4B An exploded perspective view of a catheter hub and a safety assembly separated from a housing of a catheter insertion device according to embodiments disclosed herein is shown.

[0027] Figure 5A A cross-sectional side view of a catheter insertion device according to embodiments disclosed herein is shown, showing the catheter and hub in a starting position, and with an introducer needle extending from a distal end of the catheter insertion device.

[0028] Figures 5B to 5E Various views of a catheter hub and safety assembly according to embodiments disclosed herein are shown.

[0029] Fig. 6A A cutaway perspective view of a proximal portion of a catheter insertion device according to embodiments disclosed herein is shown.

[0030] Figure 6B The embodiment disclosed herein is shown Fig. 6A Close-up view of the catheter insertion device.

[0031] Figures 6C to 6D The embodiment disclosed herein is shown Fig. 6A A cross-sectional side view of a catheter insertion device.

[0032] Fig. 7A A cutaway perspective view of a catheter insertion device including a locking device according to embodiments disclosed herein is shown.

[0033] Figure 7B The embodiment disclosed herein is shown Fig. 7A Proximal view of the locking device.

[0034] Figures 8A to 8D Various views of a catheter insertion device including a locking device according to embodiments disclosed herein are shown.

[0035] Figures 9A to 9C Various views of a catheter insertion device including a locking device according to embodiments disclosed herein are shown.

[0036] Figures 10A to 10D Various views of a catheter insertion device including a locking device according to embodiments disclosed herein are shown. DETAILED DESCRIPTION

[0037] Reference will now be made to the drawings, wherein like structures will be provided with like reference numerals. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention, and are neither restrictive nor necessarily drawn to scale.

[0038] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions.For example, "first", "second" and "third" features or steps do not need to appear in this order, and the specific embodiments including such features or steps do not need to be limited to these three features or steps.Labels such as "left", "right", "up", "down", "front", "back" etc. are used for convenience and are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such labels are used to reflect, for example, relative position, orientation or direction.Singular forms "a kind of", "one" and "the" include plural references, unless the context clearly defines otherwise.

[0039] For the sake of clarity, it should be understood that the word "proximal" refers to the direction of a user who is relatively closer to the device to be described herein, while the word "distal" refers to the direction relatively farther away from the user. For example, the "proximal", "proximal portion" or "proximal end portion" of a catheter such as disclosed herein includes a portion of the catheter that is expected to be close to the user when the catheter is used on the patient. Similarly, for example, the "proximal length" of the catheter includes the length of the catheter that is expected to be close to the user when the catheter is used on the patient. For example, the "proximal end" of the catheter includes an end of the catheter that is expected to be close to the user when the catheter is used on the patient. The proximal portion, proximal portion or proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, proximal portion or proximal length of the catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise implies, the proximal portion, proximal portion or proximal length of the catheter is not the terminal portion or terminal length of the catheter.

[0040] With respect to, for example, the "distal side," "distal portion," or "distal end portion" of a catheter disclosed herein includes a portion of a catheter that is expected to be near a patient or within a patient's body when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of a catheter that is expected to be near a patient or within a patient's body when the catheter is used on a patient. For example, the "distal end" of a catheter includes one end of a catheter that is expected to be near a patient or within a patient's body when the catheter is used on a patient. The distal portion, distal portion, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context otherwise implies, the distal portion, distal portion, or distal length of a catheter is not the terminal portion or terminal length of a catheter. Similarly, the words "comprise," "have," and "have" as used herein (including the claims) should have the same meaning as the word "comprise."

[0041] The terms "needle" and "cannula" are used interchangeably herein to refer to a member having a sharp or beveled end for insertion into an injection site on a subject. In one embodiment, the needle can be a thin, hollow tubular member.

[0042] As used herein and as Figure 4A As shown, the longitudinal axis extends parallel to the axial length of the catheter, the lateral axis extends orthogonal to the longitudinal axis, and the transverse axis extends orthogonal to the longitudinal axis and the lateral axis. As used herein, "axial" refers to along or parallel to the longitudinal axis of the needle, and the "radial" direction is the direction perpendicular to the axial direction. The forward direction is the direction toward the distal end of the device. The rearward direction is the direction toward the proximal end of the device. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art.

[0043] Embodiments disclosed herein relate to a catheter placement device, also referred to as a "catheter insertion device," that is simplified in operation and capable of one-handed placement, thereby allowing the user to simultaneously operate an ultrasound probe, etc., to maintain visualization.

[0044] refer to Figures 1 to 3 The catheter insertion device 10 generally includes a body or housing 12, a catheter assembly (including a catheter 14 with a catheter hub 16 and a safety assembly 46), an introducer needle 18, and an actuator assembly 20. The actuator assembly 20 forms a reciprocating or indexing assembly and mechanism to index and advance the catheter 14 on one end of the needle 18 in a stepwise manner by cycling through multiple stages. Each stage consists of moving the actuator assembly 20 from a first position to a second position and back to the first position to advance the catheter assembly a given distance in the distal direction.

[0045] The housing 12 of the insertion device 10 has a longitudinal dimension having a distal end 22 and a proximal end 24. In an embodiment, the housing 12 can be formed of two housing halves that are joined together by a suitable attachment mechanism. For example, the first housing half and the second housing half can be aligned by one or more pins (not shown) protruding from the first housing half, which can correspond to one or more recesses 13 ( Figure 3 ). However, other configurations of pins and recesses or similar attachment mechanisms are also contemplated, including clips, lugs, notches, protrusions, combinations thereof, and the like. The housing 12 has dimensions for supporting the introducer needle 18 and catheter 14 during use and for enabling the user to manipulate the device when positioning the catheter. Figure 3 As shown, introducer needle 18 is hollow and has a proximal end secured within interior cavity 50 of housing 12 by post 54 or other support. Needle 18 extends from the distal end of housing 12 through opening 40 to a point distal to distal end 22 of housing 12.

[0046] The housing 12 may define an interior cavity 50 forming a longitudinal passage. In an embodiment, the housing 12 has a curved side wall 26, a flat top wall 28, and a flat bottom wall 30. The flat bottom wall 30 is generally arranged to allow the device to be placed on a flat surface in a stable position, reducing the risk of falling from the surface. It will be understood that the shape of the device 10 may vary without limitation depending on the specific use, so as to provide comfort and convenience of use for the operator.

[0047] In an embodiment, an elongated opening 32 is formed in the top wall 28 for receiving a portion of the actuator assembly 20 therethrough. The housing 12 may further include a tip portion ("tip") 34 having converging sides defining the distal end 22 of the housing 12. Figure 4A As shown, two hinged doors 36 of the tip 34 are hingedly connected to the wall 26 by respective hinges 38. The hinged doors 36 can be in the closed position ( Figure 1 ) and the open position ( Figure 4A ) to access the interior cavity 50 of the housing 12 and allow the catheter 14, the catheter hub 16, the safety assembly 46, or a combination thereof to be removed from the housing 12. When the hinged door 36 is in the closed configuration, the exit opening 40 in the tip 34 enables the catheter 14 and the introducer needle 18 to extend from the distal end of the housing 12. The converging surfaces of the tip 34 enable the device to be positioned at a low angle relative to the patient's skin to assist in inserting the catheter 14 and the introducer needle 18 into the patient, reducing the risk of kinking or folding of the catheter 14.

[0048] Further details of the catheter insertion device 10 may be found in International Patent Publication WO 2018 / 170349, which is incorporated by reference into the present application in its entirety.

[0049] like Figures 3 to 4B As shown, in an embodiment, the actuator assembly 20 forming a reciprocating or indexing assembly advances the catheter assembly including the catheter 14, the catheter hub 16, the safety assembly 46, or a combination thereof, in a stepwise manner in the distal direction through a series of stages. Each stage includes the backward and forward movement of the actuator assembly 20. The forward movement of the actuator assembly 20 causes the actuator tab 76 to engage a portion of the catheter assembly and actuate the catheter assembly in the distal direction. At the completion of each forward stroke, the button 68 is pulled back, and the adjacent tab 76 of the actuator body 66 is ready for the next forward stroke by engaging that portion of the catheter assembly. As shown in FIG. Figure 3 As shown, the housing can include a plurality of flexible tabs ("housing tabs") 60. Each of the housing tabs 60 can be configured to deflect to allow the catheter assembly or a portion thereof to advance distally. Once the catheter assembly has been advanced distally of the deflected tabs 60, the tabs 60 can return to an undeflected configuration. For each backward stroke, the housing tabs 60 can engage the body 47 of the needle safety assembly 46 to prevent proximal movement of the catheter assembly. As shown, the starting position of the device 10 can be a retracted position ( Figure 1 ). However, it will be appreciated that the starting position may also be an extended position ( Figure 2 ), the actuator assembly 20 can then cycle through each stage of rearward and forward movement to advance the catheter assembly forward to the distal end of the housing 12.

[0050] Once the safety assembly body 47 and the catheter hub 16 are advanced to a forward position proximate the distal end 22 of the housing 12, the hinged door 36 is pivoted to a position such that the safety assembly body 47 and the catheter hub 16 are advanced to a forward position proximate the distal end 22 of the housing 12. Figure 4A The door 36 may be moved to the open position as shown to release the catheter hub 16 and the safety assembly 46 from the housing 12. In an embodiment, the door 36 may be moved to the open position by rotating through a longitudinal horizontal plane, such as Figure 4AAs shown. The catheter hub 16 is advanced to contact the cam surface 81 on the inner surface of the door 36 to transition the door 36 to the open position. The housing 12 can then be withdrawn proximally from the catheter hub 16 to withdraw the introducer needle 18 from the catheter 14. The safety assembly body 47 slides over the distal end 56 of the introducer needle 18 to enclose the sharp tip and prevent accidental needle stick injuries. When the body 47 of the safety assembly 46 is actuated by withdrawing the introducer needle 18, the catheter hub 16 is released and separated from the safety assembly 46. The housing 12 with the attached introducer needle 18 and the safety assembly body 47 can then be discarded. Optionally, the seal forms a valve that closes the proximal end of the catheter hub 16 to control blood backflow and allow attachment of an extension set or other device.

[0051] like Figure 4B As shown, in an embodiment, the first hinged door 36A can be hingedly connected to the top wall 28, and the second hinged door 36B can be hingedly connected to the bottom wall 30. In this way, one of the first hinged door 36A or the second hinged door 36B is transformed into an open position by rotating through a longitudinal vertical plane, such as Figure 4B As shown. In an embodiment, the first door 36A can be hingedly coupled to the housing 12, and the second door 36B can be coupled to the housing 12 in a fixed relationship relative to the housing 12, for example, by adhesion, bonding, welding, etc. Advantageously, the second door 36 configured in this way can provide a support structure for the needle 18 at the outlet opening 40 of the tip 34. In an embodiment, the second door 36B is formed to be integrally molded with the housing 12 to form a single structure. In an embodiment, the first door 36A can be coupled in a fixed relationship relative to the housing 12, and the second door 36B can be hingedly coupled to the housing 12.

[0052] Advantageously, the hinge mechanism of door 36 can simplify the manufacture and / or assembly of catheter insertion device 10 by respecting the bilateral symmetry of the device configuration. Figure 4A As shown, in the case where the housing 12 is formed by two housing halves joined together along a longitudinal vertical plane, the hinged door 36 can be connected to the side wall 26. Figure 4B As shown, where the housing 12 is formed by joining two halves along a longitudinal horizontal plane, a hinged door 36 may be coupled to the top and bottom walls 28 , 30 to facilitate manufacturing and assembly.

[0053] like Figures 5A to 5E As shown, in an embodiment, the housing 12 includes a plurality of rigid support portions ("housing support portions") 260. Further, the actuator body 66 includes a plurality of rigid support portions ("actuator support portions") 276. Figures 5B to 5EAs shown, the catheter assembly may include one or more indexing fingers 264. The indexing fingers 264 may extend from the sidewall of the safety assembly body 47 and may be angled toward the proximal end. The indexing fingers 264 may be configured to elastically deflect inwardly toward the central axis and may be biased to a position such as Figures 5B to 5E Outward position shown.

[0054] In an embodiment, the safety assembly body 47 includes a first indexing finger 264A extending from a first side of the body 47 and a second indexing finger 264B extending from a second side of the body 47. In an embodiment, the first side and the second side are opposite to each other, but other configurations are contemplated. The first indexing finger 264A extends toward the actuator support portion 276 of the actuator body 66, and the second indexing finger 264B extends toward the housing support portion 260 of the housing 12.

[0055] In use, the button 68 of the actuator assembly 20 is initially in the Figure 5A 6. The user then moves the actuator body 66 to the retracted position shown, and the user can slide the button 68 forward to the second extended position. The support portion 276 disposed toward the proximal end of the actuator body 66 engages the first indexing finger 264A disposed on the upper surface of the safety body 47 and slides the catheter assembly forward a distance corresponding to the travel distance of the actuator button 68. The housing support portion 260 on the bottom wall 30 of the housing 12 is positioned to complement the spacing and position of the actuator support portion 276.

[0056] The forward movement of the safety body 47 toward the distal end 22 of the housing 12 deflects the second indexing finger 264B until its proximal end travels distally of the housing support 260. The outwardly biased indexing finger 264B then engages the housing support 260 to hold the body 47 in the advanced position and prevent the body 47 from sliding back toward the proximal end 24 of the housing 12. The advancing movement of the body 47 advances the catheter forward over the fixed introducer needle 18.

[0057] The button 68 can then slide back toward the retracted position, in which the first indexing finger 264A deflects and slides on the adjacent actuator support 276 to engage the distally facing contact point thereon. Thus, a stage cycle is completed, which advances the catheter assembly one step in the stepwise advancement. The button 68 can then slide forward again to repeat the cycle in which the first indexing finger 264A and the second indexing finger 264B can engage the successive actuator support 276 and the housing support 260, thereby advancing the catheter 14 in a stepwise manner.

[0058] In an embodiment, the button 68 can slide between the retracted position and the extended position by manual manipulation of the user. In an embodiment, the catheter insertion device 10 may include one or more biasing members (e.g., springs) to convert the button 68 and the actuator assembly between the retracted position and the extended position. For example, from the extended position to the retracted position, or from the retracted position to the extended position. Advantageously, the biasing member can be convenient for one-handed use of the catheter insertion device 10 by automatically resetting the actuator assembly to one of the retracted position or the extended position (prepared to manually manipulate the actuator assembly 20 in subsequent steps).

[0059] In the implementation scheme, Figures 5B to 5C As shown, the indexing finger 264 is integrally molded with the safety body 47 to form a single structure. Figures 5C to 5D As shown, the indexing finger 264 is formed as a separate structure from the safety body 47 and is coupled thereto. In an embodiment, the indexing finger 264 can be formed of the same or different material as the safety body 47. Exemplary materials include plastics, polymers, metals, alloys, or any suitable elastic material. Figures 5C to 5D As shown, the indexing finger 264 extends from the collar 266. The collar 266 can extend at least partially around a portion of the safety component body 47. In an embodiment, the collar 266 extends from a first side to a second side of the safety component body 47. In an embodiment, the collar 266 surrounds the safety component body 47 to surround the longitudinal axis of the body 47. In an embodiment, the safety body 47 includes one or more recesses configured to retain a portion of the collar 266, the indexing finger 264, or a combination thereof to further secure the collar 266 / indexing finger 264 thereto.

[0060] Advantageously, the catheter insertion device 10 including the rigid actuator support 276, the housing support 260 and the flexible indexing finger 264 requires fewer moving parts. This simplifies the manufacture and assembly of the catheter insertion device 10 and provides a more robust operation of the catheter insertion device 10. Further, by forming the indexing finger as part of the safety body 47, the manufacture and assembly of the catheter insertion device 10 is further simplified. In an alternative manner in which the indexing finger is formed as a separate structure and optionally formed of a separate material, the amount of spring force or deflection resistance can be more accurately defined or modified. This allows the catheter insertion device 10 to balance the actuator button 68 and the catheter propulsion force.

[0061] like Figures 6A to 6DAs shown, in an embodiment, the catheter insertion device 10 can include a combination of a flexible housing tab 60 and a rigid actuator support 276. Other combinations can also be envisioned, for example, a rigid housing support 260 and a flexible actuator tab 76. As described herein, the catheter insertion device 10 includes a housing 12 and an actuator assembly 20, which includes a button 68 coupled to an actuator body 66. The actuator body 66 extends proximally, roughly extending to the proximal end of the housing 12, and includes a top wall 228, a first side wall 226A and a second side wall 226B. The top wall 228 extends below the top wall 28 of the housing 12 and above the catheter assembly (which includes a catheter 14, a catheter hub 16 and a safety assembly 46). The first side wall 226A and the second side wall 226B extend from the inside of the top wall 228, the side wall 26 of the housing 12 and the outside of the catheter assembly. The top wall 228 , the first side wall 226A, and the second side wall 226B can create a reverse channel within which the catheter assembly can travel along the longitudinal axis. Optionally, the actuator body 66 can include rounded or chamfered portions to fit tightly within the interior cavity 50 of the housing 12 .

[0062] In an embodiment, one of the first sidewall 226A and the second sidewall 226B can include a plurality of notches 274 extending upwardly from a lower edge of the sidewall to define a support surface 276 on a distally facing surface of the notch 274. As shown, the notch 274 defines a generally rectangular shape when viewed from a side profile, however, it will be understood that the notch 274 can also define other shapes such as a triangle or a semicircle and still be within the scope of the present invention. In an embodiment, the sidewalls 226A, 226B can include a plurality of apertures disposed therein to define a distally facing support surface 276.

[0063] Figure 6B Shows Fig. 6A10. A close-up view of the proximal end of the catheter insertion device 10 shown. As shown, the safety assembly body 47 includes a collar 266 that supports a first indexing finger 264A and a second indexing finger 264B. In an embodiment, the indexing fingers 264A, 264B can also be formed as a single piece with the safety body 47, as described herein. The collar 266 engages a portion of the safety body 47 and supports the indexing fingers 264A, 264B in an outwardly biased position. The first indexing finger 264A extends from a first side portion of the safety body 47, and the second indexing finger 264B extends from a second side portion of the safety body 47 opposite to the first side portion. The indexing fingers 264A, 264B are aligned with a plurality of notches 274 so that the proximal tip of the indexing finger 264 engages a distally facing support surface 276. The housing 12 further includes a plurality of housing tabs 60 that engage a lower portion of the safety body 47 to prevent proximal movement thereof, as described herein.

[0064] In use, the catheter insertion device 10 includes an actuator button 68 disposed in a retracted, starting position, e.g. Figure 5A The user can manipulate the actuator button 68 to move the actuator assembly 20 in the distal direction from the starting position to the extended position ( Figure 6C ).like Figure 6C 26A, and the proximal support surface 276 of the second side wall 226B (e.g., the first support surface 276a) engages the second indexing finger 264B. The actuator assembly 20 is advanced to the extended position so that the catheter assembly is advanced distally. The catheter assembly is advanced distally to the proximal tab 60. Tab 60 deflects downward to allow the catheter assembly to pass before returning to the undeflected position to engage the surface 64 on the safety assembly 46. This prevents proximal movement of the catheter assembly.

[0065] like Fig.6D As shown, the actuator assembly 20 then moves proximally from the extended position to the retracted starting position. As the actuator body 66 moves proximally, the first indexing finger 264A and the second indexing finger 264B deflect to allow a portion of the side walls 226A, 226B to pass until the adjacent notch 274 is aligned with the indexing finger 264A, 264B, thereby allowing the indexing finger to engage the adjacent support surface 276, for example, the second support surface 276b. The cycle is then repeated to advance the catheter assembly distally in a stepwise manner.

[0066] Advantageously, the embodiment including the actuator body 66 that limits the reverse passage requires relatively few moving parts for ease of manufacture and assembly. Further, the actuator body 66 provides a passage in which the catheter assembly can advance. Device 10 also provides a double contact point between the actuator assembly 20 and the safety assembly 46, which is evenly arranged around the central axis. These features provide uniform application of force and prevent the catheter assembly or its parts from pivoting relative to the longitudinal axis during distal advancement. This prevents the indexing mechanism from getting stuck and provides more robust operation.

[0067] In an embodiment, the catheter insertion device 10 may include a locking device. As described in more detail herein, the locking device may include one of a button, a collar, a slider or a tab. Generally, the locking device may selectively limit the stepwise advancement mechanism to suppress the advancement of the catheter insertion device 10 beyond the initial stage while still allowing some movements of the catheter 14 relative to the pin 18. This allows the user to destroy any adhesion that may occur during the manufacturing process between the catheter 14 and the pin 18 before the deployment catheter 14. Then, the user may selectively unlock the locking device to allow the catheter insertion device 10 to cycle through the first stage. Destroying adhesion ensures smooth, uniform advancement of each stage by progressive advancement.

[0068] like Figures 7A to 7B As shown, in an embodiment, the catheter insertion device 10 includes a locking button 240, which includes an actuator surface 242 coupled to an engagement arm 244 and can be in a locked position (e.g., Fig. 7A ) and the unlocked position. The engagement surface 244 includes a first generally circular aperture 246 defining a first diameter (x) and a second generally circular aperture 248 defining a second diameter (y). Figure 7B As shown, the first aperture 246 and the second aperture 248 may communicate to define a "keyhole" shaped aperture. Fig. 7A As shown, the safety assembly body 47 includes a cylindrical anchor portion 250 that extends proximally and defines a generally circular cross-section. The cross-section of the anchor 250 defines a diameter that is the same as or smaller than the diameter (x) of the first orifice 246. The anchor 250 also includes a flange 252 extending radially from the proximal end of the anchor portion 250. The flange 252 defines a diameter that is greater than the diameter (x) of the first orifice 246 but less than the diameter (y) of the second orifice 248.

[0069] like Fig. 7A As shown, the locking button 240 is deployed in a locked position in which the anchor 250 is disposed within the first aperture 246 and the flange 252 abuts the engagement arm 244. In this position, longitudinal movement of the safety assembly 46 and the catheter 14 and catheter hub 16 is restricted.

[0070] In an embodiment, the distance of longitudinal movement of the safety component 46 is limited to less than the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the distance of longitudinal movement of the safety component 46 is limited to approximately half of the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the safety component 46 is limited to a longitudinal distance of between 1 mm and 3 mm, although larger or smaller distances are also contemplated.

[0071] With the locking button 240 in the locked position, the user is able to move the actuator assembly 20 in order to move the catheter 14 relative to the needle 18, but is unable to move the catheter assembly 20 beyond the first step of the stepwise advancement, i.e., not as far as the next tab 60 or support 260. This movement disrupts any adhesion between the catheter 14 and the needle 18 that may have formed during manufacturing, assembly, transportation, or storage. When the user is ready to advance the catheter, the locking button 240 can be transitioned to an unlocked position in which the anchor 250 is disposed within the second orifice 248 and the flange 252 can pass through the orifice 248. This allows the actuator assembly 20 to advance the catheter assembly in a stepwise manner, as described herein. It will be understood that the configuration and position of the locking button 240 and orifices 246, 248 can be varied without departing from the spirit of the present invention. Figures 7A to 7B The configuration and position shown are different. For example, the orientation of the apertures 246, 248 can be reversed so that the unlocked position of the locking button 240 is the extended position and the locked position is the retracted position. Similarly, the position of the button 240 can extend from the lower surface, upper surface or side surface of the housing 12.

[0072] Advantageously, the locking button 240 allows the user to break any adhesion that may have formed between the catheter 14 and the needle 18 during assembly, shipping or storage. This relaxes the movement between the catheter 14 and the needle 18 before use and ensures a smooth, even and controlled action when the catheter 14 is deployed.

[0073] like Figures 8A to 8DAs shown, in an embodiment, the catheter insertion device 10 includes a locking collar 280 that limits the movement of the actuator button 68, the actuator assembly, and the catheter assembly engaged therewith. The locking collar 280 is arranged on the outer surface of the housing 12 and surrounds the housing 12 around the longitudinal axis. In an embodiment, the collar 280 surrounds a portion of the housing 12 so that the collar can be separated from the catheter insertion device 10 by sliding the collar 280 perpendicular to the longitudinal axis. The housing 12 includes one or more protrusions extending from its outer surface, for example, a first protrusion 282 and a second protrusion 284. The locking collar 280 can slide relative to the first protrusion 282 and the second protrusion 284 to transition between a locked position and an unlocked position.

[0074] like Figures 8A to 8B As shown, the locking collar 280 can be arranged in a locked position, in which the collar 280 is arranged between the first protrusion 282 and the actuator button 68 so as to cover at least a portion of the opening 32. In the locked position, longitudinal movement of the actuator assembly 20 and the catheter assembly engaged therewith is restricted.

[0075] In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance less than the length of the opening 32. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance of approximately half the length of the opening 32. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance less than the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance of approximately half the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance between about 1 mm and about 3 mm, although larger or smaller distances are also contemplated.

[0076] With the locking collar 280 in the locked position, the user can move the actuator assembly 20 to move the catheter 14 relative to the needle 18, but cannot move the catheter assembly beyond the first step of the stepwise advancement, i.e., not as far as the next housing tab 60 or housing support 260. This movement breaks any adhesion between the catheter 14 and the needle 18 that may have formed during assembly, transportation, or storage. When the user is ready to advance the catheter 14, the locking collar 280 can be removed or slid to the unlocked position, i.e., between the first protrusion 282 and the second protrusion 284, where the collar 280 does not cover the opening 32. This allows the actuator assembly 20 to advance the catheter assembly in a stepwise manner, as described herein.

[0077] In an embodiment, the first protrusion 282 is disposed at one of the distal end or the proximal end of the opening 32 and is configured to limit the movement of the collar 280 relative to the housing along the longitudinal axis to maintain the locking collar 280 in a locked position. When ready for use, the user can slide the locking collar 280 on the first protrusion 282 to an "unlocked" position. In an embodiment, the collar 280 further includes a slide 286 on the inner surface of the collar 280 to facilitate moving the locking collar 280 on the first protrusion 282.

[0078] The second protrusion 284 can be positioned at a distance from the first protrusion 282 so that the locking collar 280 can be received therebetween. In an embodiment, the first protrusion 282 and the second protrusion 284 protrude a similar height from the outer surface of the housing 12. Optionally, the locking collar 280 can be slid over the second protrusion 284 and removed from the catheter insertion device 10. In an embodiment, the second protrusion 284 protrudes further from the outer surface of the housing 12 than the first protrusion 282 and prevents the locking collar 280 from being removed from the catheter insertion device 10. Optionally, the locking collar 280 includes a contrasting color, a tactile feature, a grip feature, an alphanumeric symbol, an icon, or a combination thereof to distinguish the locking collar 280 from the locking collar of the housing 12 and notify the user whether the catheter insertion device 10 is in a locked position or an unlocked position.

[0079] like Figures 8A to 8D As shown, the locking collar 280, the first protrusion 282, and the second protrusion 284 are arranged between the actuator button 68 and the proximal end of the catheter insertion device 10, so that the collar 280 is slid in the proximal direction to the "unlocked" position. However, it will be understood that the orientation of the actuator button 68, the locking collar 280, the first protrusion 282, and the second protrusion 284 can be arranged in other configurations without departing from the spirit of the present invention. For example, the collar 280 can be slid in the distal direction to move from the locked position to the unlocked position, and optionally removed from the catheter insertion device 10.

[0080] like Figures 9A to 9C As shown, in an embodiment, the catheter insertion device 10 may include a locking slide 270, which can be in a locked position ( Fig. 9A ) and an unlocked position ( Fig. 9C ). In an embodiment, the locking slide 270 can be slid perpendicular to the longitudinal axis (ie, the direction of travel of the actuator assembly 20) to engage the notch 268. However, it will be understood that other orientations of the slide 270 and the notch 268 are also contemplated.

[0081] The longitudinal width of the slider 270 may define a first width (a). The longitudinal width of the notch 268 may define a second width (b). In an embodiment, the width (a) of the slider is less than the width (b) of the notch. The notch 268 may engage the slider 270 to limit the movement of the actuator assembly 20. Fig. 9A As shown, the locking slide 270 is deployed in a locked position in which the slide 270 engages the notch 268. In this position, longitudinal movement of the safety actuator assembly 20 and the catheter assembly engaged therewith is restricted.

[0082] In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance less than the length of the opening 32. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance of approximately half the length of the opening 32. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance less than the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance of approximately half the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance between about 1 mm and about 3 mm, although larger or smaller distances are also contemplated.

[0083] With the locking slide 270 in the locked position, the user can move the actuator assembly 20 to move the catheter 14 relative to the needle 18, but cannot move the catheter assembly beyond the first step of stepwise advancement, i.e., not as far as the next housing tab 60 or housing support 260. This movement breaks any adhesion between the catheter 14 and the needle 18 that may have formed during assembly, shipping, or storage. When the user is ready to advance the catheter, the locking slide 270 can be moved to the unlocked position, in which the actuator assembly 20 can advance the catheter assembly in a stepwise manner, as described herein.

[0084] Figures 10A to 10D An embodiment of the catheter insertion device 10 including a locking tab 290 is shown. Fig. 10A A plan view of the catheter insertion device 10 is shown, and Fig. 10BA cross-sectional side view of the catheter insertion device 10 is shown with the locking tab 290 in a "locked" position, i.e., disposed within the guide slot 77 of the housing 12. It should be noted that the proximal end 74 of the actuator body 66 includes a guide pin 75, which is received within the slot 77 to stabilize the proximal end 74 of the actuator body 66. Further details thereof may be found in WO 2018 / 170349, which is incorporated herein by reference in its entirety.

[0085] Fig. 10C A cross-sectional plan view of the catheter insertion device 10 is shown, and Fig. 10D A cross-sectional side view of the catheter insertion device 10 is shown, wherein the locking tab 290 is in an "unlocked" position, i.e., removed from the slot 77. In an embodiment, the catheter insertion device 10 includes a first slot 77A disposed on a first side of the housing 12 and a second slot 77B disposed on a second side of the housing 12 opposite the first side. In an embodiment, the locking tab 290 can be disposed through any one of the first slot 77A or the second slot 77B. In an embodiment, the locking tab 290 can be disposed through both the first slot 77A and the second slot 77B.

[0086] like Fig. 10B As shown, in the "locked" position, the locking tab 290 is disposed between the proximal end of the actuator assembly 20 and the inner surface of the housing 12, i.e., between the guide pin 75 and the proximal edge of the slot 77, to limit the movement of the actuator assembly 20 and the catheter 14. The longitudinal width (t) of the locking tab 290 can be less than the longitudinal length of the slots 77A, 77B, and can be modified to change the amount of restriction applied to the actuator assembly 20.

[0087] In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to less than the longitudinal length of the first slot 77A or the second slot 77B. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance of approximately half of the longitudinal length of the first slot 77A or the second slot 77B. In an embodiment, the distance of the longitudinal movement of the actuator assembly 20 is limited to less than the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the distance of the longitudinal movement of the actuator assembly 20 is limited to approximately half of the longitudinal distance between adjacent housing supports 260, adjacent actuator supports 276, adjacent housing tabs 60, or adjacent actuator tabs 76. In an embodiment, the longitudinal movement of the actuator assembly 20 is limited to a distance between about 1 mm and about 3 mm, although larger or smaller distances are also contemplated.

[0088] In the case where locking button 240 is in the locked position, the user can move actuator assembly 20, so that relative to needle 18, catheter 14 can not be moved beyond the first step of progressive advancement, that is, not far to the next tab 60 or support 260. This motion destroys any adhesion between catheter 14 and needle 18 that may have been formed during manufacture, assembly, transportation or storage. When the user is ready to advance catheter, locking tab 290 can be removed. This allows actuator assembly 20 to advance catheter assembly in a progressive manner, as described herein. Optionally, locking device (for example, locking tab 290) can include contrasting colors, tactile features, gripping features, alphanumeric symbols, icons or combinations thereof, to distinguish locking tab 290 from the locking tab of housing 12, and notify the user whether catheter insertion device 10 is in locked position or unlocked position.

[0089] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in detail, the intention of these specific embodiments is not to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be obvious to those of ordinary skill in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Therefore, without departing from the scope of the concepts provided herein, changes may be made to the specific embodiments disclosed herein.

Claims

1. A catheter placement device, comprising: case; a needle extending from a distal end of the housing; a catheter assembly coaxially disposed over the needle, comprising a catheter supported by a catheter hub and a safety assembly including a first indexing finger; and An actuator assembly configured to transition longitudinally between a first position and a second position, the actuator assembly comprising: an actuator button extending through an elongated opening in the housing; and an actuator body comprising a plurality of actuator supports, wherein the first indexing finger engages a first actuator support of the plurality of actuator supports and the actuator assembly advances the catheter assembly distally in a stepwise manner as the actuator assembly moves between the first position and the second position, Wherein the first indexing finger is integrally molded with the safety assembly to form a single structure, the first indexing finger being configured to flexibly deform as the actuator body moves from the second position to the first position.

2. The catheter placement device of claim 1, wherein the housing comprises a plurality of housing tabs that engage the safety component to prevent proximal movement of the safety component.

3. The catheter placement device of claim 1, wherein the housing includes a plurality of housing supports that engage a second indexing finger extending from the safety assembly to prevent proximal movement of the second indexing finger.

4. The catheter placement device of claim 1, wherein the actuator body comprises a top wall, a first side wall, and a second side wall defining a reverse channel, and the catheter assembly moves through the reverse channel along the longitudinal axis.

5. The catheter placement device of claim 4, wherein one of the first side wall or the second side wall comprises a plurality of notches defining the plurality of actuator supports.

6. The catheter placement device of claim 4, wherein one of the first side wall or the second side wall comprises a plurality of apertures defining the plurality of actuator supports.

7. The catheter placement device of claim 1, wherein the housing comprises a first door and a second door disposed at a distal end of the housing and configured to pivot through a horizontal plane between an open position and a closed position.

8. The catheter placement device of claim 7, wherein the shell comprises a first shell half and a second shell half joined along a longitudinal vertical plane, the first door being hingedly connected to the first shell half, and the second door being hingedly connected to the second shell half.

9. The catheter placement device of claim 1, wherein the housing comprises a first hinged door disposed at a distal end of the housing and configured to pivot through a vertical plane.

10. The catheter placement device of claim 9, wherein the housing comprises a first housing half and a second housing half joined along a longitudinal horizontal plane, the first hinged door being hingedly coupled to the first housing half.

11. The catheter placement device according to claim 1 further includes a locking device that transitions between a locked position and an unlocked position, wherein the locked position allows movement of the catheter relative to the needle and limits distal advancement of the catheter assembly in a step-by-step manner.

12. The catheter placement device of claim 11, wherein movement of the catheter relative to the needle is limited to less than a longitudinal distance between the first actuator support and a second actuator support adjacent the first actuator support.

13. The catheter placement device of claim 11, wherein movement of the catheter relative to the needle is limited to less than half of a longitudinal distance between the first actuator support and a second actuator support adjacent to the first actuator support.

14. The catheter placement device of claim 11, wherein movement of the catheter relative to the needle is limited to a distance between 1 mm and 3 mm.

15. A catheter placement device according to claim 11, wherein the locking device includes a locking button, the locking button includes an engagement arm, the engagement arm has a first orifice defining a first diameter and a second orifice defining a second diameter, the second diameter is larger than the first diameter, the first orifice is connected to the second orifice to define a lock hole shape, the lock hole shape receives the anchor portion of the safety component passing therethrough.

16. The catheter placement device of claim 15, wherein the locking button transitions between the locked position and an unlocked position, the anchor portion being disposed within the first orifice in the locked position and disposed within the second orifice in the unlocked position.

17. A catheter placement device according to claim 16, wherein the anchoring portion includes a flange extending radially from the proximal end of the anchoring portion, the flange defining a diameter greater than the first diameter and less than the second diameter, and when the locking button is in the locking position, the flange abuts against the engagement arm.

18. The catheter placement device of claim 11, wherein the locking device comprises a locking collar slidably engaged with an outer surface of the housing and longitudinally transitioning between the locked position and the unlocked position.

19. The catheter placement device of claim 18, wherein the locking collar circumscribes a longitudinal axis of the housing, the locking collar covering a portion of the elongated opening in the locked position to restrict movement of the actuator assembly.

20. The catheter placement device of claim 18, wherein the locking collar is disposed between the actuator button and a first protrusion in the locked position and between the first protrusion and a second protrusion in the unlocked position.

21. The catheter placement device of claim 11, wherein the locking device comprises a locking slide disposed on the actuator button and, when in the locked position, sliding perpendicular to the longitudinal axis to engage the notch.

22. The catheter placement device of claim 21, wherein the longitudinal width of the slider is less than the longitudinal width of the notch to allow movement of the actuator button in the locked position and limit distal advancement of the catheter assembly in a step-wise manner.

23. The catheter placement device of claim 21, wherein the locking slide in the unlocked position aligns with the actuator button to disengage the notch and allow the actuator assembly to move between the first position and the second position.

24. The catheter placement device of claim 11, wherein the locking device includes a locking tab disposed between the actuator assembly and the housing in the locked position to restrict movement of the actuator assembly.

25. The catheter placement device of claim 24, wherein the locking tab extends through a slot in the housing, the tab defining a longitudinal width that is less than a longitudinal length of the slot.

26. A catheter placement device comprising: case; a needle extending from a distal end of the housing; a catheter assembly coaxially disposed over the needle, comprising a catheter supported by a catheter hub and a safety assembly including a first indexing finger; and An actuator assembly configured to transition longitudinally between a first position and a second position, the actuator assembly comprising: an actuator button extending through an elongated opening in the housing; and an actuator body comprising a plurality of actuator supports, wherein the first indexing finger engages a first actuator support of the plurality of actuator supports and the actuator assembly advances the catheter assembly distally in a stepwise manner as the actuator assembly moves between the first position and the second position, The first indexing finger is supported by a collar and formed as a separate structure from the safety assembly, the collar is coupled to the safety assembly, and the first indexing finger is configured to flexibly deform as the actuator body moves from the second position to the first position.

27. A catheter placement device comprising: case; a needle extending from a distal end of the housing; a catheter assembly coaxially disposed over the needle, comprising a catheter supported by a catheter hub and a safety assembly including a first indexing finger; and An actuator assembly configured to transition longitudinally between a first position and a second position, the actuator assembly comprising: an actuator button extending through an elongated opening in the housing; and an actuator body comprising a plurality of actuator supports, wherein the first indexing finger engages a first actuator support of the plurality of actuator supports and the actuator assembly advances the catheter assembly distally in a stepwise manner as the actuator assembly moves between the first position and the second position, The actuator body includes a top wall, a first side wall, and a second side wall defining a reverse channel, and the catheter assembly moves through the reverse channel along the longitudinal axis.

28. The catheter placement device of claim 27, wherein one of the first sidewall or the second sidewall comprises a plurality of notches defining the plurality of actuator supports.

29. The catheter placement device of claim 27, wherein one of the first sidewall or the second sidewall comprises a plurality of apertures defining the plurality of actuator supports.

30. A catheter placement device comprising: case; a needle extending from a distal end of the housing; a catheter assembly coaxially disposed over the needle, comprising a catheter supported by a catheter hub and a safety assembly including a first indexing finger; An actuator assembly configured to transition longitudinally between a first position and a second position, the actuator assembly comprising: an actuator button extending through an elongated opening in the housing; and an actuator body comprising a plurality of actuator supports, wherein the first indexing finger engages a first actuator support of the plurality of actuator supports and the actuator assembly advances the catheter assembly distally in a stepwise manner as the actuator assembly moves between the first position and the second position; and A locking device transitions between a locked position that permits movement of the catheter relative to the needle and limits distal advancement of the catheter assembly in a stepwise manner and an unlocked position.

31. The catheter placement device of claim 30, wherein movement of the catheter relative to the needle is limited to less than a longitudinal distance between the first actuator support and a second actuator support adjacent the first actuator support.

32. The catheter placement device of claim 30, wherein movement of the catheter relative to the needle is limited to less than half of the longitudinal distance between the first actuator support and a second actuator support adjacent to the first actuator support.

33. The catheter placement device of claim 30, wherein movement of the catheter relative to the needle is limited to a distance between 1 mm and 3 mm.

34. A catheter placement device according to claim 30, wherein the locking device includes a locking button, the locking button includes an engagement arm, the engagement arm has a first orifice defining a first diameter and a second orifice defining a second diameter, the second diameter is larger than the first diameter, the first orifice is connected to the second orifice to define a lock hole shape, and the lock hole shape receives the anchor portion of the safety component passing therethrough.

35. The catheter placement device of claim 34, wherein the locking button transitions between the locked position and an unlocked position, the anchoring portion being disposed within the first orifice in the locked position and disposed within the second orifice in the unlocked position.

36. A catheter placement device according to claim 35, wherein the anchoring portion includes a flange extending radially from the proximal end of the anchoring portion, the flange defining a diameter greater than the first diameter and less than the second diameter, and when the locking button is in the locking position, the flange abuts against the engagement arm.

37. The catheter placement device of claim 30, wherein the locking device comprises a locking collar slidably engaged with an outer surface of the housing and longitudinally transitioning between the locked position and the unlocked position.

38. The catheter placement device of claim 37, wherein the locking collar circumscribes a longitudinal axis of the housing, the locking collar covering a portion of the elongated opening in the locked position to restrict movement of the actuator assembly.

39. The catheter placement device of claim 37, wherein the locking collar is disposed between the actuator button and the first protrusion in the locked position and between the first protrusion and the second protrusion in the unlocked position.

40. The catheter placement device of claim 30, wherein the locking device comprises a locking slide disposed on the actuator button and, when in the locked position, sliding perpendicular to the longitudinal axis to engage the notch.

41. The catheter placement device of claim 40, wherein the longitudinal width of the slide is less than the longitudinal width of the notch to allow movement of the actuator button in the locked position and limit distal advancement of the catheter assembly in a step-wise manner.

42. The catheter placement device of claim 40, wherein the locking slide in the unlocked position aligns with the actuator button to disengage the notch and allow the actuator assembly to move between the first position and the second position.

43. The catheter placement device of claim 30, wherein the locking device includes a locking tab disposed between the actuator assembly and the housing in the locked position to restrict movement of the actuator assembly.

44. The catheter placement device of claim 43, wherein the locking tab extends through a slot in the housing, the tab defining a longitudinal width that is less than a longitudinal length of the slot.

Images