Patent Publication Number: US-2023158275-A1

Title: Midline Catheter Placement Device

Description:
PRIORITY 
     This application is a division of U.S. patent application Ser. No. 16/996,769, filed Aug. 18, 2020, now U.S. Pat. No. 11,559,665, which claims the benefit of priority to U.S. Provisional Application No. 62/888,946, filed Aug. 19, 2019, each of which is incorporated by reference in its entirety into this application. 
    
    
     BACKGROUND 
     Midline catheters are generally used for parenteral nutrition, intravenous (“IV”) fluid replacement and the administration of analgesics and antibiotics. Midline catheters are inserted at the bedside using sterile techniques and can remain in place for several weeks. The 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 veins. 
     The potential advantages of a midline catheter are the reduced frequency of repeated venipunctures for labs/restarts, decreased incidence of catheter related infections, extended implant/indwell duration, improved clinical outcomes, patient satisfaction and associated cost savings. Placing the catheter tip in the larger diameter veins in the upper arm compared to the smaller veins provide improved drug delivery therapy and hemodilution. Midline catheters can be used for infusing contrast media at higher flow rates that are typically done by central venous (“CV”) catheters such as peripherally inserted central venous catheter (“PICC”) applications. 
     Prior midline catheter devices typically include an integral guidewire. The guidewire is advanced through the lumen of the needle and into the vein after the needle accesses the vein. Often an ultrasonic probe or imaging device is used to locate the needle in the desired location. The catheter is then advanced over the guidewire into the vein. The needle and guidewire are then detached and separated from the catheter which remains in place in the vein. 
     These prior devices generally require the guidewire to be fully deployed by moving a sliding member into a locked/detent position. To advance the catheter, the user must put down the ultrasonic probe and use both hands to advance the catheter and complete the final steps of the procedure. This results in a loss of the visualization of the vein and the location of the catheter relative to the vein. 
     Catheter placement and advancement is dependent on holding the device in a stationary position with one hand while manipulating the catheter advancing mechanism in the other hand without the use of the ultrasonic imaging to assist in proper placement of the catheter. Once the catheter is fully advanced, the user must re-position the ultrasonic probe to re-establish the image and confirm proper placement of the catheter. The operation requires a series of sequential steps with specialized training. The additional exchange of hand positions from the ultrasonic probe to the device and back to the probe adds complexity to the procedure and risks the success of the proper placement of the catheter. 
     What is needed, therefore is a catheter placement device that streamlines the steps involved in catheter placement, as well as being operated with a single hand, while still providing the same functionality of current catheter placement devices. 
     SUMMARY 
     Briefly summarized, embodiments disclosed herein are directed to extended dwell peripheral IV catheter (“PIVC”) devices that provide a longer length “mini-midline” catheter. The catheter would be placed similarly to a PIVC, without the need for a guidewire and would only require one-handed operation. Placement would be carried out under ultrasound imaging guidance and can access deeper vessels or facilitate difficult venous access (“DVA”) procedures. The catheter would be able to successfully extend the dwell time for patients requiring medium/long term IV therapy, for example between 5 and 30 days. 
     Disclosed herein is a catheter placement device including, a housing, a needle extending from a distal end of the housing, a catheter assembly disposed coaxially over the needle, including 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 including, an actuator button extending through an elongate opening in the housing, and an actuator body including a plurality of actuator abutments, wherein the first indexing finger engages a first actuator abutment of the plurality of actuator abutments and the actuator assembly distally advances the catheter assembly in a stepwise manner as the actuator assembly moves between the first position and the second position. 
     In some embodiments, the first indexing finger is integrally molded with the safety assembly to form a single structure, the first indexing finger 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 is formed as a separate structure from the safety assembly, the collar being coupled to the safety assembly, and the first indexing finger 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 thereof. The housing includes a plurality of housing abutments that engage a second indexing finger extending from the safety assembly to prevent proximal movement thereof. 
     In some embodiments, the actuator body includes a top wall, a first side wall, and a second side wall that define an inverse channel through which the catheter assembly moves along a longitudinal axis. One of the first side wall or the second side wall includes a plurality of notches that define the plurality of actuator abutments. One of the first side wall or the second side wall includes a plurality of apertures that define the plurality of actuator abutments. The housing includes a first door and a second door disposed at a distal end thereof and configured to pivot through a horizontal plane between an open position and a closed position. The housing includes a first housing half and a second housing half joined along a longitudinally vertical plane, the first door hingedly coupled to the first housing half and the second door hingedly coupled to the second housing half. 
     In some embodiments, the housing includes a first hinged door disposed at a distal end thereof and configured to pivot through a vertical plane. The housing includes a first housing half and a second housing half joined along a longitudinally horizontal plane, the first door hingedly coupled to the first housing half. In some embodiments, the catheter placement device further includes a lockout device that transitions between a locked position and an unlocked position, the locked position allowing a movement of the catheter relative to the needle and restricting distal advancement of the catheter assembly in the stepwise manner. The movement of the catheter relative to the needle is restricted to less than a longitudinal distance between the first actuator abutment and a second actuator abutment, adjacent to the first actuator abutment. The movement of the catheter relative to the needle is restricted to less than half a longitudinal distance between the first actuator abutment and a second actuator abutment, adjacent to the first actuator abutment. The movement of the catheter relative to the needle is restricted to a distance of between 1 mm to 3 mm. 
     In some embodiments, the lockout device includes a lockout button including an engagement arm having a first aperture defining a first diameter, and a second aperture defining a second diameter, the second diameter being larger than the first diameter, the first aperture communicating with the second aperture to define a keyhole shape that receives an anchor portion of the safety assembly therethrough. The lockout button transitions between the locked position and an unlocked position, the anchor portion is disposed within the first aperture in the locked position and the second aperture in the unlocked position. The anchor portion includes a flange that extends radially from a proximal end of the anchor portion, the flange defining a diameter that is larger than the first diameter and smaller than the second diameter, the flange abuts against the engagement arm when the lockout button is in the locked position. 
     In some embodiments, the lockout device includes a lockout collar slidably engaged with an outer surface of the housing and transitions longitudinally between the locked position and the unlocked position. The lockout collar encircles a longitudinal axis of the housing, the lockout collar covering a portion of the elongate opening in the locked position to restrict movement of the actuator assembly. The lockout 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. The lockout device includes a lockout slider disposed on the actuator button and slides perpendicular to a longitudinal axis to engage a notch, when in the locked position. A longitudinal width of the slider is less than a longitudinal width of the notch to allow movement of the actuator button in the locked position and restrict distal advancement of the catheter assembly in the stepwise manner. 
     In some embodiments, the lockout slider 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. The lockout device includes a lockout tab interposed between the actuator assembly and the housing in the locked position, which restricts movement of the actuator assembly. The lockout tab extends through a slot in the housing, the tab defining a longitudinal width that is less than a longitudinal length of the slot. 
     Also disclosed is a method of inserting a catheter including, providing a catheter insertion device having a housing, a needle extending from a distal end of the housing, an actuator assembly including an actuator button and an actuator body, a catheter assembly disposed coaxially over the needle having, a catheter supported by a catheter hub and a safety assembly, and a lockout device transitionable between a locked position and an unlocked position, the locked position permitting movement of the catheter relative to the needle and inhibiting advancement of the catheter in a stepwise manner, actuating the actuator button with the lockout device in the locked position to move the catheter relative to the needle, transitioning the lockout device from the locked position to the unlocked position, inserting the needle into a patient to access a vasculature thereof, and actuating the actuator button from a first position to a second position to advance the catheter in the stepwise manner relative to the needle. 
     In some embodiments, the actuator body includes a plurality of actuator abutments, and the safety assembly includes an indexing finger, the indexing finger engaging an actuator abutment of the plurality of actuator abutments as the actuator button moves from the first position to the second position, and the indexing finger deflecting as the actuator button moves from the second position to the first position. 
     Also disclosed is a method of advancing a catheter over a needle including, providing a catheter placement device having a housing including a plurality of housing tabs and a needle extending from a distal end thereof. The catheter placement device further having a catheter assembly including a catheter disposed coaxially over the needle and engaging a first housing tab of the plurality of housing tabs, an actuator assembly 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, and a lockout device transitionable between a locked position and an unlocked position. The locked position restricts movement of the catheter assembly between the first housing tab and the second housing tab, and the unlocked position permits movement of the catheter assembly between the first housing tab and the second housing tab. The method further includes actuating the actuator button with the lockout device in the locked position to move the catheter relative to the needle while preventing the catheter assembly from advancing from the first housing tab to the second housing tab, transitioning the lockout device from the locked position to the unlocked position, inserting the needle into a patient to access a vasculature thereof, 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. 
     In some embodiments, the lockout device is one of a lockout button, a lockout collar, a lockout slider and a lockout tab. The housing includes a first hinged door and a second hinged door, each disposed at the distal end of the housing and configured to pivot to an open position to release the catheter hub. 
    
    
     
       DRAWINGS 
       A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG.  1    shows a perspective view of a catheter insertion device showing the actuator in a starting position, in accordance with embodiments disclosed herein. 
         FIG.  2    shows a perspective view of the catheter insertion device of  FIG.  1    showing the actuator in the forward actuated position, in accordance with embodiments disclosed herein. 
         FIG.  3    shows a cutaway side view of the catheter insertion device of  FIG.  1    showing the catheter and hub in the starting position, and with the introducer needle extending from the distal end of the catheter insertion device, in accordance with embodiments disclosed herein. 
         FIGS.  4 A- 4 B  show perspective exploded views of the catheter hub and safety assembly separated from the housing of a catheter insertion device, in accordance with embodiments disclosed herein. 
         FIG.  5 A  shows a cutaway side view of a catheter insertion device showing the catheter and hub in the starting position, and with the introducer needle extending from the distal end of the catheter insertion device, in accordance with embodiments disclosed herein. 
         FIGS.  5 B- 5 E  show various views of a catheter hub and safety assembly, in accordance with embodiments disclosed herein. 
         FIG.  6 A  shows a perspective cutaway view of a proximal portion of a catheter insertion device, in accordance with embodiments disclosed herein. 
         FIG.  6 B  shows a close up view of the catheter insertion device of  FIG.  6 A , in accordance with embodiments disclosed herein. 
         FIGS.  6 C- 6 D  show cutaway side views of the catheter insertion device of  FIG.  6 A , in accordance with embodiments disclosed herein. 
         FIG.  7 A  shows a perspective cutaway view of a catheter insertion device including a lockout device, in accordance with embodiments disclosed herein. 
         FIG.  7 B  shows a proximal end view of the lockout device of  FIG.  7 A , in accordance with embodiments disclosed herein. 
         FIGS.  8 A- 8 D  show various views of a catheter insertion device including a lockout device, in accordance with embodiments disclosed herein. 
         FIGS.  9 A- 9 C  show various views of a catheter insertion device including a lockout device, in accordance with embodiments disclosed herein. 
         FIGS.  10 A- 10 D  show various views of a catheter insertion device including a lockout device, in accordance with embodiments disclosed herein. 
     
    
    
     DESCRIPTION 
     Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale. 
     Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the 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 group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. 
     For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a user using the device to be described herein, while the word “distal” refers to a direction relatively further from the user. For example, with respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a user when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the user when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the user when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter. 
     With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.” 
     The terms “needle” and “cannula” can be used herein interchangeably to refer to a member having a sharpened or beveled end for insertion into an injection site on a subject. In one embodiment, the needle can be a thin hollow tubular member. 
     As used herein, and as shown in  FIG.  4 A , the longitudinal axis extends parallel to an axial length of the catheter, a lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes. As used herein, the “axial” means along or parallel to the longitudinal axis of the needle and the “radial” direction is a direction perpendicular to the axial direction. The forward direction is the direction toward the distal end of the device. The backward direction is the direction toward the proximal end of the device. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. 
     Embodiments disclosed herein are directed to a catheter placement device, also termed “catheter insertion device,” with a streamlined operation and the ability to be placed with a single hand, allowing a user to also operate an ultrasound probe, or the like, to maintain visualization. 
     In reference to  FIGS.  1 - 3   , the catheter insertion device  10  generally includes a main body or housing  12 , a catheter assembly, including a catheter  14  having a catheter hub  16  and a safety assembly  46 , an introducer needle  18 , and an actuator assembly  20 . The actuator assembly  20  forms a shuttling or indexing assembly and mechanism to index and advance the catheter  14  over the end of the needle  18  in a stepwise manner by cycling through a plurality of stages. Each stage consisting 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 a distal direction. 
     The housing  12  of the insertion device  10  has a longitudinal dimension with a distal end  22  and a proximal end  24 . In an embodiment, the housing  12  can be formed from two housing halves that are joined together by a suitable attachment mechanism. For example, a first housing half and a second housing half can be aligned by one or more pins (not shown) protruding from a first housing half, which can correspond with one or more recesses  13  on a second housing half ( FIG.  3   ). However, other configurations of pins and recesses, or similar attachment mechanisms including clips, lugs, notches, protrusions, combinations thereof, or the like are also contemplated. The housing  12  has a dimension for supporting the introducer needle  18  and catheter  14  during use and to enable the user to manipulate the device in positioning the catheter. Also shown in  FIG.  3   , the introducer needle  18  is hollow and has a proximal end fixed within an interior cavity  50  of the housing  12  by a post  54  or other support. The needle  18  extends from a distal end of the housing  12  through the opening  40  to a point that is distal of the distal end  22  of the housing  12 . 
     The housing  12  can define an interior cavity  50  forming a longitudinal passage. In an embodiment, the housing  12  has curved side walls  26 , a flat top wall  28  and a flat bottom wall  30 . The flat bottom wall  30  is generally provided to allow the device to be placed on a flat surface in a stable position with reduced risk of falling off the surface. It will be appreciated that the shape of the device  10  can vary without limitation depending on the particular use to provide comfortable and convenient use by the operator. 
     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  can further include a tip portion (“tip”)  34  having converging sides that defines the distal end  22  of the housing  12 . As shown in  FIG.  4 A , two hinged doors  36  of tip  34  are hingedly connected to the walls  26  by a respective hinge  38 . The hinged doors  36  can transition between a closed position ( FIG.  1   ) and an open position ( FIG.  4 A ) to access the interior cavity  50  of the housing  12  and allow removal of the catheter  14 , catheter hub  16 , safety assembly  46 , or combinations thereof, from the housing  12 . An outlet opening  40  in tip  34  enables the catheter  14  and introducer needle  18  to extend from the distal end of the housing  12  when the hinged doors  36  are in the closed configuration. The converging surfaces of tip  34  enable the device to be positioned at a low angle with respect to the skin of the patient to assist in inserting the catheter  14  and introducer needle  18  into the patient with reduced risk of kinking or folding of the catheter  14 . 
     Further details of the catheter insertion device  10  can be found in International Patent Publication WO 2018/170349, which is incorporated by reference in its entirety into this application. 
     As shown in  FIGS.  3 - 4 B , in an embodiment, the actuator assembly  20  that forms the shuttling or indexing assembly, advances a catheter assembly, which includes the catheter  14 , catheter hub  16 , safety assembly  46 , or combinations thereof, in a distal direction and in a stepwise manner through a series of stages. Each stage comprising of a back and a forward movement of the actuator assembly  20 . A forward movement of the actuator assembly  20  causes an actuator tab  76  to engage a portion of the catheter assembly and urge the catheter assembly in a distal direction. At the completion of each forward stroke, the button  68  is pulled back and an adjacent tab  76  of the actuator body  66  is readied for the next forward stroke, by engaging the portion of the catheter assembly. As shown in  FIG.  3   , the housing can include a plurality of flexible tabs (“housing tabs”)  60 . Each tab of the housing tabs  60  can be configured to deflect to allow the catheter assembly, or portion thereof, to pass distally. Once the catheter assembly has advanced distally of a deflected tab  60 , the tab  60  can return to the undeflected configuration. With each backward stroke, a housing tab  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 ( FIG.  1   ). However it will be appreciated that the starting position may also be an extended position ( FIG.  2   ), the actuator assembly  20  can then be cycled through the backward and forward movement of each stage to advance the catheter assembly forward to a distal end of the housing  12 . 
     Once the safety assembly body  47  and catheter hub  16  are advanced to a forward position, proximate a distal end  22  of housing  12 , the hinged doors  36  are pivoted to the open position as shown in  FIG.  4 A  to release catheter hub  16  and safety assembly  46 , from the housing  12 . In an embodiment, the doors  36  can transition to the open position by rotating through a longitudinally horizontal plane, as shown in  FIG.  4 A . The catheter hub  16  is advanced to contact cam surfaces  81  on the inner surface of the doors  36  to transition the doors  36  to the open position. The housing  12  can then be withdrawn proximally from catheter hub  16  to withdraw introducer needle  18  from 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 an accidental needle stick injuries. The catheter hub  16  is released and separated from safety assembly  46  when the body  47  of safety assembly  46  is actuated by the withdrawing of introducer needle  18 . Housing  12 , with the attached introducer needle  18  and safety assembly body  47  can then be discarded. Optionally a seal forms a valve that closes a proximal end of the catheter hub  16  to control blood backflow and to allow attachment of an extension set or other devices. 
     As shown in  FIG.  4 B , in an embodiment, a first hinged door  36 A can be hingedly coupled with a top wall  28  and a second hinged door  36 B can be hingedly coupled with a bottom wall  30 . As such, one of the first hinged door  36 A or second hinged door  36 B transitions to the open position by rotating through a longitudinally vertical plane, as shown in  FIG.  4 B . In an embodiment, a first door  36 A can be hingedly coupled to the housing  12  and a second door  36 B can be coupled to the housing  12  in a fixed relationship relative to the housing  12 , e.g. attached thereto by adhesive, bonding, welding, etc. Advantageously, the second door  36  configured as such can provide a supporting structure for the needle  18  at the outlet opening  40  of tip  34 . In an embodiment, the second door  36 B is formed as integrally molded with the housing  12  to form a single structure. In an embodiment, the first door  36 A can be coupled in a fixed relationship relative to the housing  12  and the second door  36 B can be hinged coupled to the housing  12 . 
     Advantageously, the hinging mechanisms of the doors  36  can simplify fabrication and/or assembly of the catheter insertion device  10  by following the bi-lateral symmetry of the device construction. For example, as shown in  FIG.  4 A , where the housing  12  is formed from two housing halves that are joined together along a longitudinally vertical plane, the hinged doors  36  can be coupled with the side walls  26 . Similarly, as shown in  FIG.  4 B , where the housing  12  is formed by joining two halves along a longitudinally horizontal plane, the hinged doors  36  can be coupled with the top and bottom walls  28 ,  30  to facilitate fabrication and assembly. 
     As shown in  FIGS.  5 A- 5 E , in an embodiment, the housing  12  includes a plurality of rigid abutments (“housing abutments”)  260 . Further, the actuator body  66  includes a plurality of rigid abutments (“actuator abutments”)  276 . As shown in  FIGS.  5 B- 5 E , the catheter assembly can include one or more indexing fingers  264 . The indexing finger  264  can extend from a side wall of the safety assembly body  47  and can be angled towards a proximal end. The indexing finger  264  can be configured to elastically deflect inward towards a central axis, and can be biased to an outward position as shown in  FIGS.  5 B- 5 E . 
     In an embodiment, the safety assembly body  47  includes a first indexing finger  264 A extending from a first side of the body  47  and a second indexing finger  264 B extending from a second side of the body  47 . In an embodiment, the first and second sides are opposite each other, although other configurations are contemplated. The first indexing finger  264 A extends towards the actuator abutments  276  of the actuator body  66 , and the second indexing finger  264 B extends toward the housing abutments  260  of the housing  12 . 
     In use, the button  68  of the actuator assembly  20  is initially in the retracted position as shown in  FIG.  5 A , and the user can slide the button  68  forward to a second, extended position. An abutment  276  disposed toward the proximal end of the actuator body  66  engages the first indexing finger  264 A disposed on an upper surface of the safety body  47  and slides the catheter assembly forward a distance corresponding to the distance of travel of the actuator button  68 . The housing abutments  260  on the bottom wall  30  of the housing  12  are positioned to complement the spacing and location of the actuator abutments  276 . 
     The forward movement of the safety body  47  toward the distal end  22  of the housing  12  causes the second indexing finger  264 B to deflect until a proximal end thereof travels distally of a housing abutment  260 . The indexing finger  264 B, which is biased outwardly, then engages the housing abutment  260  to retain 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 . 
     The button  68  can then slide backward toward the retracted position where the first indexing finger  264 A deflects and slides over an adjacent actuator abutment  276  to engage a distally facing contact point thereon. Thus completing a stage cycle that advances the catheter assembly by a step of the stepwise advancement. The button  68  can then slide forward again to repeat the cycle where the first indexing finger  264 A and the second indexing finger  264 B can engage consecutive actuator abutments  276  and housing abutments  260  to advance the catheter  14  in a stepwise manner. 
     In an embodiment, the button  68  can slide between the retracted position and the extended position by manual manipulation by the user. In an embodiment, the catheter insertion device  10  can include a one or more biasing members, e.g. a spring, to transition the button  68  and actuator assembly between the retracted position and the extending 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 facilitate one-handed use of the catheter insertion device  10  by automatically resetting the actuator assembly to one of the retracted or extended positions, ready for manual manipulation of the actuator assembly  20  in a subsequent step. 
     In an embodiment, as shown in  FIGS.  5 B- 5 C , the indexing fingers  264  are integrally molded with the safety body  47  to form a single structure. In an embodiment, as shown in  FIGS.  5 C- 5 D , the indexing fingers  264  are formed as a separate structure from that of the safety body  47  and coupled thereto. In an embodiment, the indexing finger  264  can be formed from the same material as the safety body  47  or from a different material. Exemplary materials include plastic, polymers, metals, alloys, or any suitably resilient material. As shown in  FIGS.  5 C-D , the indexing fingers  264  extend from a collar  266 . The collar  266  can extend at least partially around a portion of the safety assembly body  47 . In an embodiment, the collar  266  extends from a first side to a second side of the safety assembly body  47 . In an embodiment the collar  266  encircles the safety assembly 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 , indexing finger  264 , or combinations thereof, to further secure the collar  266 /indexing fingers  264  thereto. 
     Advantageously, the catheter insertion device  10  including rigid actuator abutments  276 , housing abutments  260 , and flexible indexing fingers  264  requires less moving parts. This simplifies manufacture and assembly of the catheter insertion device  10  as well as providing a more robust operation of the catheter insertion device  10 . Further, by forming the indexing fingers as part of the safety body  47 , the manufacture and assembly of the catheter insertion device  10  is further simplified. In the alternative that the indexing fingers are formed as a separate structure, and optionally of a separate material, the amount of spring forces or resistance to deflection, can be more accurately defined or modified. This allows the catheter insertion device  10  to balance the actuator button  68  and catheter advancement forces. 
     As shown in  FIGS.  6 A- 6 D , in an embodiment, the catheter insertion device  10  can include a combination of flexible housing tabs  60  and rigid actuator abutments  276 . Other combinations are also contemplated for example rigid housing abutments  260  and flexible actuator tabs  76 . As described herein, the catheter insertion device  10  includes a housing  12  and an actuator assembly  20  that includes a button  68  coupled to an actuator body  66 . The actuator body  66  extends proximally, substantially to a proximal end of the housing  12 , and includes a top wall  228 , a first side wall  226 A, and a second side wall  226 B. The top wall  228  extends below the top wall  28  of the housing  12  and above the catheter assembly, which includes the catheter  14 , catheter hub  16 , and safety assembly  46 . The first side wall  226 A, and the second side wall  226 B extend from the top wall  228 , inside of the side walls  26  of the housing  12 , and outside of the catheter assembly. The top wall  228 , first side wall  226 A, and second side wall  226 B can create an inverse channel within which the catheter assembly can travel along a longitudinal axis. Optionally, the actuator body  66  can include a rounded or chamfered portion to fit snuggly within the interior cavity  50  of the housing  12 . 
     In an embodiment, one of the first side wall  226 A and the second side wall  226 B can include a plurality of notches  274  extending upwards from a lower edge of the side wall to define an abutment surface  276  on a distally facing surface of the notch  274 . As shown, the notches  274  define a substantially rectangular shape when viewed from a side profile, however it will be appreciated that notches  274  can also define other shapes, such as triangular or semi-circular, and still remain within the scope of the present invention. In an embodiment, the side walls  226 A,  226 B can include a plurality of apertures disposed therein to define the distally facing abutment surfaces  276 . 
       FIG.  6 B  shows a close up view of the proximal end of the catheter insertion device  10  shown in  FIG.  6 A . As shown, the safety assembly body  47  includes a collar  266  that supports the first indexing finger  264 A and the second indexing finger  264 B. In an embodiment, the indexing fingers  264 A,  264 B 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  264 A,  264 B in an outwardly biased position. The first indexing finger  264 A extends from a first side portion of the safety body  47 , and the second indexing finger  264 B extends from a second side portion of the safety body  47 , opposite the first side portion. The indexing fingers  264 A,  264 B are aligned with the plurality of notches  274  so that a proximal tip of the indexing fingers  264  engage a distally facing abutment 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. 
     In use, the catheter insertion device  10  includes an actuator button  68  disposed in the retracted, starting position, for example, as shown in in  FIG.  5 A . A user can manipulate the actuator button  68  to move the actuator assembly  20  in a distal direction from the starting position, to an extended position ( FIG.  6 C ). As shown in  FIG.  6 C , a proximal abutment surface  276 , of the first side wall  226 A engages the first indexing fingers  264 A, and a proximal abutment surface  276 , e.g. a first abutment surface  276   a , of the second side wall  226 B engages the second indexing finger  264 B. Advancing the actuator assembly  20  to the extended position distally advances the catheter assembly. The catheter assembly is advanced distally of a proximal tab  60 . The tab  60  deflects downwards to allow the catheter assembly to pass, before returning to the undeflected position to engage surface  64  on the safety assembly  46 . This prevents proximal movement of the catheter assembly. 
     As shown in  FIG.  6 D , the actuator assembly  20  is then moved proximally, from the extended position to the retracted, starting position. As the actuator body  66  moves proximally, the first indexing finger  264 A and the second indexing finger  264 B deflect to allow a portion of the side walls  226 A,  226 B to pass until an adjacent notch  274  aligns with the indexing fingers  264 A,  264 B allowing the indexing fingers to engage an adjacent abutment surface  276 , e.g. a second abutment surface  276   b . The cycle then repeats to advance the catheter assembly distally in a stepwise manner. 
     Advantageously, embodiments including the actuator body  66  defining an inverse channel require relatively less moving parts to facilitate manufacture and assembly. Further, the actuator body  66  provides a channel within which the catheter assembly can travel. The device  10  also provides dual contact points between the actuator assembly  20  and the safety assembly  46  that are disposed evenly about a central axis. These features provide an even application of force and prevents the catheter assembly, or portions thereof, from pivoting relative to the longitudinal axis during distal advancement. This prevents the indexing mechanism from jamming and provides a more robust operation. 
     In an embodiment, the catheter insertion device  10  can include a lockout device. As described in more detail herein, the lockout device can include one of a button, collar, slider or tab. In general, the lockout device can selectively restrict the stepwise advancement mechanism to inhibit the catheter insertion device  10  from advancing beyond an initial stage, while still allowing some movement of the catheter  14  relative to the needle  18 . This allows a user to break any adhesion between the catheter  14  and the needle  18  that may have occurred during manufacture, prior to deployment of the catheter  14 . The user can then selectively unlock the lockout device to allow the catheter insertion device  10  to cycle through a first stage. Breaking the adhesion ensures a smooth, uniform advancement through each stage of the stepwise advancement. 
     As shown in  FIGS.  7 A- 7 B , in an embodiment, the catheter insertion device  10  includes a lockout button  240  that includes an actuator surface  242  coupled with an engagement arm  244 , and can transition between a locked position (e.g.  FIG.  7 A ) and an unlocked position. The engagement surface  244  includes a first, substantially circular aperture  246  defining a first diameter (x) and a second, substantially circular aperture  248  defining a second diameter (y). As shown in  FIG.  7 B , the first aperture  246  and second aperture  248  can communicate to define a “keyhole” shaped aperture. As shown in  FIG.  7 A , the safety assembly body  47  includes a cylindrical anchor portion  250 , extending proximally therefrom, and defining a substantially circular cross-section. The cross-section of the anchor  250  defines a diameter that is the same or less than the diameter (x) of the first aperture  246 . The anchor  250  also includes a flange  252  extending radially from a proximal end of the anchor portion  250 . The flange  252  defines a diameter that is larger than the diameter (x) of the first aperture  246  but smaller than the diameter (y) of the second aperture  248 . 
     As shown in  FIG.  7 A , the lockout button  240  is deployed in the locked position where the anchor  250  is disposed within the first aperture  246  and the flange  252  abuts against the engagement arm  244 . In this position the longitudinal movement of the safety assembly  46 , as well as catheter  14  and catheter hub  16 , are restricted. 
     In an embodiment, the longitudinal movement of the safety assembly  46  is restricted to a distance that is less than the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the safety assembly  46  is restricted to a distance that is substantially half the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the safety assembly  46  is restricted to a longitudinal distance of between 1 mm to 3 mm, however greater or lesser distances are also contemplated. 
     With the lockout button  240  in the locked position a user is able to move the actuator assembly  20  so as to move the catheter  14  relative to the needle  18 , but is not able to move the catheter assembly  20  beyond a first step of the stepwise advancement, i.e. not as far as the next tab  60 , or abutment  260 . This movement breaks loose any adhesion between the catheter  14  and the needle  18  that may have formed during manufacture, assembly, transport or storage. When the user is ready to advance the catheter, the lockout button  240  can be transitioned to the unlocked position, where the anchor  250  is disposed within the second aperture  248  and the flange  252  can pass through the aperture  248 . This allows the actuator assembly  20  to advance the catheter assembly in a stepwise manner, as described herein. It will be appreciated that the configuration and location of the lockout button  240  and apertures  246 ,  248  can vary from that shown in  FIGS.  7 A- 7 B  without departing from the spirit of the invention. For example, the orientation of the apertures  246 ,  248  can be reversed so that the unlocked position of the lockout button  240  is an extended position and a locked position is a retracted position. Similarly, the location of the button  240  can extend from a lower, upper, or side surface of the housing  12 . 
     Advantageously, the lockout button  240  allows the user to break loose any adhesion between the catheter  14  and the needle  18  that may have formed during assembly, transport or storage. This loosens the movement between the catheter  14  and the needle  18  prior to use and ensures a smooth, uniform and controlled action when the catheter  14  is deployed. 
     As shown in  FIGS.  8 A- 8 D , in an embodiment, the catheter insertion device  10  includes a lockout collar  280  that restricts movement of the actuator button  68 , the actuator assembly, and the catheter assembly engaged therewith. The lockout collar  280  is disposed on an outer surface of the housing  12  and encircles the housing  12  about the longitudinal axis. In an embodiment, the collar  280  encircles a portion of the housing  12  such that it can be detached from the catheter insertion device  10  by sliding the collar  280  perpendicular to the longitudinal axis. The housing  12  includes one or more protrusions, for example a first protrusion  282  and a second protrusion  284 , extending from an outer surface thereof. The lockout collar  280  can slide relative to the first protrusion  282  and a second protrusion  284  to transition between a locked position and an unlocked position. 
     As shown in  FIGS.  8 A- 8 B , the lockout collar  280  can be disposed in a locked position where the collar  280  is disposed 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, the longitudinal movement of the actuator assembly  20 , and the catheter assembly engaged therewith, is restricted. 
     In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the length of the opening  32 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the length of the opening  32 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance of between about 1 mm to about 3 mm, however greater or lesser distances are also contemplated. 
     With the lockout collar  280  in the locked position, a user is able to move the actuator assembly  20  so as to move the catheter  14  relative to the needle  18 , but is not able to move the catheter assembly beyond a first step of the stepwise advancement, i.e. not as far as the next housing tab  60 , or housing abutment  260 . This movement breaks loose any adhesion between the catheter  14  and the needle  18  that may have formed during assembly, transport or storage. When the user is ready to advance the catheter  14 , the lockout 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. 
     In an embodiment, the first protrusion  282  is disposed at one of a distal end or a proximal end of the opening  32  and configured to restrict movement of the collar  280  relative to the housing along a longitudinal axis to maintain the lockout collar  280  in the locked position. When ready for use, the user can slide the lockout collar  280  over the first protrusion  282  to the “unlocked” position. In an embodiment, the collar  280  further includes a skive  286  on an inner surface of the collar  280  to facilitate moving the lockout collar  280  over the first protrusion  282 . 
     The second protrusion  284  can be positioned a distance from the first protrusion  282  so that the lockout 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 lockout collar  280  can be slid past the second protrusion  284  and be 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 lockout collar  280  from being removed from the catheter insertion device  10 . Optionally, the lockout collar  280  includes a contrasting color, tactile features, gripping features, alphanumeric symbols, icons, or combinations thereof, to distinguish the lockout collar  280  from that of the housing  12  and notify the user that the catheter insertion device  10  is in the locked or unlocked position. 
     As shown in  FIGS.  8 A- 8 D , the lockout collar  280 , first protrusion  282 , and second protrusion  284  are disposed between the actuator button  68  and a proximal end of the catheter insertion device  10  such that the collar  280  is slid in a proximal direction to the “unlocked” position. It will be appreciated, however, that the orientation of the actuator button  68 , lockout collar  280 , first protrusion  282 , and second protrusion  284  can be disposed in other configurations without departing from the spirit of the invention. For example, the collar  280  can be slid in a distal direction to move from the locked position to the unlocked position and optionally be removed from the catheter insertion device  10 . 
     As shown in  FIGS.  9 A- 9 C , in an embodiment, the catheter insertion device  10  can include a lockout slider  270  that can transition between a locked position, to restrict the movement of the actuator button  68  ( FIG.  9 A ), and an unlocked position to allow the actuator assembly to move along the elongate opening  32  ( FIG.  9 C ). In an embodiment, the lockout slider  270  can be slid perpendicular to the longitudinal axis, i.e. the direction of travel of the actuator assembly  20 , to engage notch  268 . However, it will be appreciated that other orientations of slider  270  and notch  268  are also contemplated. 
     A longitudinal width of the slider  270  can define a first width (a). A longitudinal width of the notch  268  can define a second width (b). In an embodiment, the width of the slide (a) is less than a width of the notch (b). The notch  268  can engage the slider  270  to restrict the movement of the actuator assembly  20 . As shown in  FIG.  9 A , the lockout slider  270  is deployed in the locked position where the slider  270  engages notch  268 . In this position the longitudinal movement of the safety actuator assembly  20  and the catheter assembly engaged therewith, are restricted. 
     In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the length of the opening  32 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the length of the opening  32 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance of between about 1 mm to about 3 mm, however greater or lesser distances are also contemplated. 
     With the lockout slider  270  in the locked position a user is able to move the actuator assembly  20  so as to move the catheter  14  relative to the needle  18 , but is not able to move the catheter assembly beyond a first step of the stepwise advancement, i.e. not as far as the next housing tab  60 , or housing abutment  260 . This movement breaks loose any adhesion between the catheter  14  and the needle  18  that may have formed during assembly, transport or storage. When the user is ready to advance the catheter, the lockout slider  270  can be moved to the unlocked position, where the actuator assembly  20  can advance the catheter assembly in a stepwise manner, as described herein. 
       FIGS.  10 A- 10 D  show an embodiment of the catheter insertion device  10  including a lockout tab  290 .  FIG.  10 A  shows a plan view of the catheter insertion device  10  and  FIG.  10 B  shows a cutaway side view of the catheter insertion device  10  with the lockout tab  290  in the “locked” position, i.e. disposed within guide slot  77  of housing  12 . To note, a proximal end  74  of the actuator body  66  includes a guide pin  75  that is received within slot  77  to stabilize the proximal end  74  of the actuator body  66 . Further details of which can be found in WO 2018/170349, which is incorporated by reference in its entirety herein. 
       FIG.  10 C  shows a cutaway plan view of the catheter insertion device  10  and  FIG.  10 D  shows a cutaway side view of the catheter insertion device  10  with the lockout tab  290  in the “unlocked” position, i.e. removed from slot  77 . In an embodiment, the catheter insertion device  10  includes a first slot  77 A disposed on a first of the housing  12  and a second slot  77 B disposed on a second side of the housing  12 , opposite the first side. In an embodiment, the lockout tab  290  can be disposed through either of the first slot  77 A or the second slot  77 B. In an embodiment, the lockout tab  290  can be disposed through both of the first and second slots  77 A,  77 B. 
     As shown in  FIG.  10 B , in the “locked” position, the lockout tab  290  is disposed between a proximal end of the actuator assembly  20  and an inner surface of the housing  12 , i.e. between the guide pin  75  and a proximal edge of the slot  77 , to restrict movement of the actuator assembly  20 , and catheter  14 . The longitudinal width (t) of the lockout tab  290  can be less than the longitudinal length of the slots  77 A,  77 B, and can be modified to vary the amount of restriction imposed on the actuator assembly  20 . 
     In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the longitudinal length of the first slot  77 A or the second slot  77 B. In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the longitudinal length of the first slot  77 A or the second slot  77 B. In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is less than the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance that is substantially half of the longitudinal distance between adjacent housing abutments  260 , adjacent actuator abutments  276 , adjacent housing tabs  60 , or adjacent actuator tabs  76 . In an embodiment, the longitudinal movement of the actuator assembly  20  is restricted to a distance of between about 1 mm to about 3 mm, however greater or lesser distances are also contemplated. 
     With the lockout button  240  in the locked position a user is able to move the actuator assembly  20  so as to move the catheter  14  relative to the needle  18 , but is not able to move the catheter assembly beyond a first step of the stepwise advancement, i.e. not as far as the next tab  60 , or abutment  260 . This movement breaks loose any adhesion between the catheter  14  and the needle  18  that may have formed during manufacture, assembly, transport or storage. When the user is ready to advance the catheter, the lockout tab  290  can be removed. This allows the actuator assembly  20  to advance the catheter assembly in a stepwise manner, as described herein. Optionally, the lockout device, e.g. the lockout tab  290 , can include a contrasting color, tactile features, gripping features, alphanumeric symbols, icons, or combinations thereof, to distinguish the lockout tab  290  from that of the housing  12  and notify the user that the catheter insertion device  10  is in the locked or unlocked position. 
     While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.