Patent Publication Number: US-2022226616-A1

Title: Catheter assembly housing and related devices and methods

Description:
RELATED APPLICATIONS 
     This application claims benefit of U.S. Provisional Patent Application No. 63/139,668, filed on Jan. 20, 2021, entitled CATHETER ASSEMBLY HOUSING AND RELATED DEVICES AND METHODS, which is incorporated herein in its entirety. 
    
    
     BACKGROUND 
     A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. The catheter may also be used for withdrawing blood from the patient. 
     The catheter may include an over-the-needle peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. 
     In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of a catheter assembly that includes the catheter. After placement of the needle has been confirmed, the clinician may remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion. 
     Catheter assembly use tends to generate a significant amount of waste. In addition to packaging needed to ensure sterility of catheter assembly components prior to use, packaging must also enclose safety components intended to be immediately discarded, such as a needle cover. In practice, the needle cover resides over the sharp distal tip of the introducer needle to protect against accidental needle sticks prior to use. The needle cover, however, must be removed and discarded before the needle can be used. Additionally, after the needle is used and removed from the vasculature, both the needle and associated needle hub must also be discarded. 
     The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. 
     SUMMARY 
     The present disclosure relates generally to vascular access devices and related devices, systems, and methods. In some embodiments, a vascular access device may include a housing having a proximal end, a distal end, and a slot extending longitudinally between the proximal end and the distal end. In some embodiments, the vascular access device may include a catheter assembly including a catheter hub and a catheter extending distally from the catheter hub. In some embodiments, the catheter and the catheter hub may be disposed within the housing. 
     In one set of example embodiments, the vascular access device may include a needle assembly including a needle hub having a translation feature and an introducer needle having a sharp distal tip. In some embodiments, the introducer needle extends distally from the needle hub through the catheter. In some embodiments, the translation feature is moveable along the slot to translate the needle hub between the proximal end of the housing and the distal end of the housing. 
     In some embodiments, the catheter hub may extend beyond the distal end of the housing in response to the translation feature moving from a proximal end of the slot to a distal end of the slot. In some embodiments, the needle hub may be maintained within the housing in response to the translation feature moving from the proximal end of the slot to the distal end of the slot. 
     In some embodiments, an adapter may be coupled to the needle hub. In some embodiments, the adapter may include a distal end, a proximal end, and a compressed tube therebetween. The proximal end of the adapter may be coupled to the needle hub such that the compressed tube expands in response to the needle hub being retracted in a proximal direction within the housing. 
     In some embodiments, a distal end of the adapter may include a luer connector. In some embodiments, the translation feature may include a tab coupled to the needle hub and extending through the slot. In some embodiments, the housing may include an elongate barrel. In some embodiments, a removable barrier, such as a peel foil, may be coupled to the distal end of the housing. 
     In some embodiments, the translation may be configured to move along the slot in a distal direction to advance the introducer needle and may be configured to move along the slot in a proximal direction to retract the introducer needle. In some embodiments, the housing may include a lock mechanism to selectively secure the adapter in position relative to the housing. In some embodiments, at least a portion of the lock mechanism may be disposed at the distal end of the housing. 
     In some embodiments, the vascular access device may include a vent plug disposed within the needle hub and configured to allow air to exit the needle hub. In some embodiments, the adapter may include a catheter hub lock to secure a position of the catheter hub relative to the adapter. 
     In a second set of example embodiments, a method for advancing and shielding a needle may include advancing a translation feature distally along a vascular access device to advance a catheter into a vasculature of a patient. In some embodiments, the vascular access device may include a housing, a catheter assembly, and a needle assembly. In some embodiments, the housing may include a proximal end, a distal end, and a slot extending longitudinally between the proximal end and the distal end. In some embodiments, the catheter assembly may include a catheter hub and a catheter extending distally therefrom. In some embodiments, at least a portion of the catheter assembly may be disposed within the housing. 
     In some embodiments, the needle assembly may include a needle hub, an introducer needle extending distally from the needle hub through the catheter, and a translation feature coupled to the needle hub and configured to move longitudinally along the slot to translate the needle hub within the housing. In some embodiments, the introducer needle and the catheter may be configured to advance beyond the distal end of the housing in response to the translation feature moving distally along the slot. 
     In some embodiments, the vascular access device may further include an adapter coupled to the needle hub. In some embodiments, the adapter may include a distal end, a proximal end, and a compressed tube therebetween. In some embodiments, the method may include securing a position of a distal end of the adapter relative to the distal end of the housing in response to the translation feature being disposed proximate to the distal end of the slot. In some embodiments, the translation feature may be retracted in a proximal direction along to retract the needle hub within the housing. In some embodiments, a length of the compressed tube within the housing may be expanded in response to retracting the translation feature. In some embodiments, the method may include shielding the introducer needle within the compressed tube in response to retracting the translation feature along the slot. 
     It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  is an upper perspective view of an example vascular access device, according to some embodiments; 
         FIG. 2  is a top view of the vascular access device of  FIG. 1 , according to some embodiments; 
         FIG. 3  is an exploded view of an example needle assembly, an example catheter assembly, and an example adapter of the vascular access device of  FIG. 1 , according to some embodiments; 
         FIG. 4  is a cross-sectional view of the vascular access device of  FIG. 1 , according to some embodiments; 
         FIG. 5A  is an upper perspective view of the adapter of  FIG. 3 , according to some embodiments; 
         FIG. 5B  is a distal end view of a portion of the adapter of  FIG. 3 , according to some embodiments; 
         FIG. 6  is a cross-sectional view of the adapter of  FIG. 3 , according to some embodiments; 
         FIG. 7A  is a cross-sectional view of an example housing, according to some embodiments; 
         FIG. 7B  is a perspective view of the housing of  FIG. 7A , according to some embodiments; 
         FIG. 8A  is a top view of an example needle hub, according to some embodiments; 
         FIG. 8B  is a cross-sectional view of the needle hub of  FIG. 8A , according to some embodiments; 
         FIG. 9  is an upper perspective view of the vascular access system of  FIG. 1 , illustrating a user peeling away an example removable barrier, according to some embodiments; 
         FIG. 10  is a top view of the vascular access device of  FIG. 1 , illustrating the needle hub in an example ready position, according to some embodiments; 
         FIG. 11  is an upper perspective view of the vascular access device of  FIG. 1 , illustrating the needle hub in an example use position, according to some embodiments; 
         FIG. 12  is an upper perspective view of the vascular access device of  FIG. 1 , illustrating the needle hub in an example retracted position, according to some embodiments; 
         FIG. 13  is a top view of the vascular access device of  FIG. 1  after use, illustrating disposal of a portion of the vascular access device, according to some embodiments; 
         FIG. 14  is an upper perspective view of another example vascular access device, according to some embodiments; 
         FIG. 15  is a top view of the vascular access device of  FIG. 14 , illustrating the needle hub in the ready position, according to some embodiments; 
         FIG. 16  is an upper perspective view of the vascular access device of  FIG. 14 , illustrating the needle hub in the use position, according to some embodiments; 
         FIG. 17  is an upper perspective view of the vascular access device of  FIG. 14 , illustrating the needle hub in the retracted position, according to some embodiments; 
         FIG. 18  is a top view of the vascular access device of  FIG. 14  after use, illustrating disposal of a portion of the vascular access device, according to some embodiments; and 
         FIG. 19  is a top view of another example vascular access device, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIGS. 1-4 , in some embodiments, a vascular access device  30  may include a housing  32  extending along a longitudinal axis and having a proximal end  34  and a distal end  36 . In some embodiments, the housing  32  may monolithically formed as a single unit and/or may include a rigid material such as a biocompatible polymer or another suitable material. In some embodiments, the housing  32  may include an elongate barrel shape or another suitable shape. 
     In some embodiments, the grip element  37  may be disposed towards the distal end  36  of the housing  32  to accommodate a user&#39;s grasp. In some embodiments, the grip element  37  may extend laterally from opposing sides of the housing  32 . In these and other embodiments, the grip element  37  may include one or more textured surfaces to facilitate the user&#39;s grip. 
     In some embodiments, a removable barrier  38  may be coupled to the distal end  36  of the housing  32  to maintain sterility of internal components. In some embodiments, the removable barrier  38  may be disposable and may be coupled to the housing  32  via an adhesive, press fit, or other suitable mechanism. In some embodiments, for example, the removable barrier  38  may include foil or another material configured to be peeled back or otherwise easily removed by the user. For example, in some embodiments, the removable barrier  38  may include foil, plastic, paper, composite, or any other suitable disposable material. Some embodiments of the removable barrier  38  may be coupled to the housing  32  via a press fit or another suitable mechanism to protect the sterility of internal components. In some embodiments, the removable barrier  38  may include a pull tab or other feature or device coupled to or integrated with the removable barrier  38  to facilitate quick and easy removal. 
     In some embodiments, the housing  32  may include a lumen  39  extending along the longitudinal axis between the proximal end  34  and the distal end  36 . In some embodiments, the lumen  39  may include a shape and dimensions to accommodate various internal components. In some embodiments, for example, the vascular access device  30  may include a needle assembly having a needle hub  40  and a needle  42  extending distally therefrom. In some embodiments, the needle hub  40  may be slidably disposed within the lumen  39 . In some embodiments, the needle hub  40  may be coupled to a proximal end of the needle  42  such that a sharp distal tip of the needle  42  may extend from the distal end of the housing  32  to selectively access a patient&#39;s vasculature. 
     In some embodiments, one or more slots  44  may extend from an interior surface to an exterior surface of the housing  32 . In some embodiments, the slots  44  may extend longitudinally along the housing  32  between the distal end  36  and the proximal end  34 . 
     In some embodiments, the needle assembly may include a translation feature such as one or more tabs  45  extending outwardly from the needle hub  40 . In some embodiments, the one or more tabs  45  may extend through the slots  44  to enable a user to access the tabs  45  to translate the needle hub  40  along the longitudinal axis within the housing  32 . As illustrated, in some embodiments, the tabs  45  may extend laterally from opposing sides of the needle hub. Some embodiments of the tabs  45  may be generally planar or wing-like to facilitate manual manipulation of the tabs  45  and associated translation of the needle hub  40 . 
     In some embodiments, the distal end  36  of the housing  32  may include a lock mechanism to secure a position of an adapter  46  relative to the housing  32 . In some embodiments, the lock mechanism may include a mechanical locking device or other feature coupled to or integrated with the distal end  36  of the housing  32 . For example, in some embodiments, a distal end of the lumen  39  may include one or more protrusions  47 , notches, grooves, or other suitable features to engage a corresponding feature of the adapter  46 . In some embodiments, the lock mechanism may be actuated by adjusting or manipulating a proximal end of the needle hub  40  by, for example, retracting the needle hub  40  in a proximal direction and/or laterally rotating the needle hub  40  within the lumen  39 . 
     In some embodiments, the internal components of the housing  32  may include one or more of the following: the needle assembly, the adapter  46  including a compressed tube  48 , and a catheter assembly  49 . In some embodiments, the compressed tube  48  may include multiple extendable folds  50 . In some embodiments, the needle hub  40  may include a collar  52  at a distal end of the needle hub  40  and configured to couple to a proximal end of the adapter  46 . In some embodiments, the needle  42  may extend through the collar  52 . In some embodiments, a vent plug  53  may be coupled to a proximal end of the needle hub  40 , as discussed in more detail below. 
     In some embodiments, the catheter assembly  49  may include a catheter hub  54 , which may include a proximal end  56 , a distal end  58 , and a lumen extending therethrough. In some embodiments, the catheter assembly  49  may include a catheter  60 , which may extend distally from the distal end  58  of the catheter hub  54 . In some embodiments, the catheter  60  may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the proximal end  56  of the catheter hub  54  may include a luer connector, such as the female luer connector  62  illustrated. 
     In some embodiments, the distal end of the adapter  46  may include a luer connector  64  configured to engage a corresponding luer connector  62  of the catheter hub  54 . In some embodiments, the distal end of the adapter  46  may include a male luer connector  64  configured to engage a corresponding female luer connector  62  of the catheter hub  54 . In some embodiments, a septum  66  and/or a septum actuator  68  may be disposed within the catheter hub  54 . 
     In some embodiments, the needle  42  may extend from a distal end of the needle hub  40 . In some embodiments, the needle  42  may extend through the internal components when the needle hub  40  is in a ready position. In some embodiments, translating the needle hub  40  in a distal direction within the housing  32  may push the internal components distally such that at least a portion of the catheter hub  54 , the catheter  60 , and/or the needle  42  may extend distal to the distal end  36  of the housing  32 . In this position, the catheter  60  may be ready for insertion into the vasculature of a patient. 
     In some embodiments, a distal end of the compressed tube  48  may be secured within a distal end of the adapter  46 . In some embodiments, a proximal end of the compressed tube  48  may be secured to the collar  52  and/or distal end of the needle hub  40 . In some embodiments, the compressed tube  48  may include silicone, food grade silicone or another suitable material. In some embodiments, the extendable folds  50  may be corrugated, similar to an expandable straw. In some embodiments, the extendable folds  50  may be configured such that the extendable folds  50  contact or are disposed in close proximity to each other when the needle hub  40  is in the ready position such that the needle hub  40  contacts the adapter  46 . 
     In some embodiments, the extendable folds  50  may be configured to flatten and separate in response to the needle hub  40  being retracted within the housing  32 . In some embodiments, the needle hub  40  may be longitudinally distanced from the adapter  46  in the retracted position. 
     In some embodiments, the compressed tube  48  may increase in length in response to the needle hub  40  being retracted within the housing  32 . In some embodiments, the length of the compressed tube  48  may increase such that the compressed tube  48  may shield a length of the needle  42  within the lumen  39 . In some embodiments, the extendable folds  50  may result in the compressed tube  48  having a greater cross-sectional diameter in the ready position than in the retracted position. 
     Referring now to  FIGS. 5A-5B , in some embodiments, the adapter  46  may include a catheter hub lock  70  to prevent or limit rotational movement between the adapter  46  and the catheter hub  54 . In some embodiments, the catheter hub lock  70  may be coupled to or integrated with a distal end of the luer connector  64 . In some embodiments, the catheter hub lock  70  may include a protrusion or other feature configured to mechanically engage a corresponding feature such as an aperture  72  disposed on a proximal end of the catheter hub  54 . In some embodiments, the protrusion may engage the aperture  72  in response to rotation of the adapter  46  relative to the catheter hub  54 . In some embodiments, the catheter hub lock  70  may thereby secure a position of the adapter  46  with respect to the catheter hub  54 . 
     Referring now to  FIG. 6 , in some embodiments, the compressed tube  48  may be retained within the adapter  46  such that a distal end of the compressed tube  48  may be disposed proximal to the luer connector  64 . In some embodiments, the distal end of the compressed tube  48  may be coupled to an interior surface of the adapter  46  via an adhesive, a press fit, or by any other suitable mechanism or device. 
     Referring now to  FIGS. 7A-7B , in some embodiments, one or more slots  44  may be disposed between the proximal end  34  and the distal end  36  of the housing  32 . In some embodiments, as illustrated herein, the housing  32  may include an elongate barrel-shaped body. In some embodiments, a grip element  37  may be coupled to or integrated with the distal end  36  of the body of the housing  32 . In some embodiments, a distal end of the slot  44  may be disposed within or proximate to a proximal end of the grip element  37 . In some embodiments, the grip element  37  may thereby provide a distal stop for the translation feature or tab  45 , for example. In some embodiments, engagement of the translation feature or tab  45  with the grip element  37  may provide a snap lock to secure a position of the needle hub  40  relative to the housing  32 . 
     Similarly, in some embodiments, a proximal end of one or more of the slots  44  may include a snap lock or other mechanism to engage the needle hub  40  and/or the translation feature or tab  45  when the needle hub  40  is in the retracted position. In some embodiments, the snap lock may selectively engage and secure the needle hub  40  and/or the translation feature or tabs  45  relative to the housing  32 . In some embodiments, the slot  44  may narrow such that the tab  45  may snap past the narrowing to lock into place relative to the housing  32 . 
     In some embodiments, the translation feature or tabs  45  may be translated in a distal direction to advance the catheter assembly  49 , the adapter  46 , and the needle assembly through the housing  32 . In some embodiments, the tabs  45  may be translated in a proximal direction along the housing  32  to retract the needle  42  through the catheter assembly  49  and separate the needle hub  40  from the adapter  46 . 
     Referring now to  FIGS. 8A-8B , in some embodiments, the needle hub  40  may include a vent plug  53  disposed at or near its proximal end. In some embodiments, the vent plug  53  may be configured to allow air but not fluid to exit the needle hub  40 . In some embodiments, the vent plug  53  may include a porous material or membrane. 
     Referring now to  FIGS. 9-18 , example embodiments of a method for using a vascular access device  30  to advance a catheter and shield an introducer needle after use are illustrated.  FIGS. 9-13  illustrate embodiments of the vascular access device  30  that include multiple translation features or tabs  45 .  FIGS. 14-18 , on the other hand, illustrate embodiments of the vascular access device  30  that include a single translation feature or tab  45 . 
     As shown in  FIGS. 9 and 14 , some embodiments may include removing and/or discarding a removable barrier  38  from the distal end  36  of the housing  32 . In some embodiments, the vascular access device  30  may include a needle having a sharp distal tip disposed within the housing  32  prior to use for safety. As shown in  FIGS. 11 and 16 , a user may grip the translation feature or tabs  45  to translate the needle hub  40  in a distal direction within the housing  32 . In some embodiments, this may also move the needle, the catheter assembly  49 , and the adapter  46  distally within the housing  32 . 
     In this manner, in some embodiments, the needle hub  40  may be distally translated to a ready position such that the sharp distal tip  24  of the needle  42  may extend beyond the distal end  36  of the housing  32 . In some embodiments, the sharp distal tip  24  of the needle  42  may then be manipulated to break tip adhesion such that the sharp distal tip  24  may penetrate the vasculature. In these and other embodiments, the catheter  60  may be advanced into the vasculature in response to entry of the needle  42  into the vasculature. In some embodiments, entry of the catheter  60  into the vasculature may be confirmed by verifying blood flashback. For example, in some embodiments, blood flashback may flow distally through the needle  42  and out of a notch in the needle  42  into a space between the needle  42  and the catheter  60 . In some embodiments, blood flashback may flow into a flashback chamber. 
     Referring now to  FIGS. 12 and 17 , in some embodiments, the needle  42  may be removed from the vasculature after blood flashback has been confirmed. In some embodiments, the needle  42  may be removed by retracting the needle hub  40  in a proximal direction. In some embodiments, the translation feature or one or more tabs  45  may be gripped by the user and moved in the proximal direction along the slots  44  to retract the needle hub  40  and associated needle  42 . 
     In some embodiments, the lock mechanism may be actuated to secure the adapter  46  at the distal end  36  of the housing  32 . In some embodiments, the lock mechanism may be actuated by any mechanical, electrical, magnetic, or other suitable mechanism or device. In some embodiments, the lock mechanism may include a groove, indentation, protrusion, or other device or feature configured to engage or interact with the adapter  46  to retain the adapter  46 . In some embodiments, the lock mechanism may include a groove, indentation, protrusion or other device or feature configured to engage or interact with the needle hub  40  upon retraction of the needle  42  to retain the needle hub  40  in the retracted position proximate to the proximal end  34  of the housing  32 . 
     In some embodiments, as discussed previously, the distal end of the adapter  46  may be secured at the distal end  36  of the housing  32  upon insertion of the needle  42  into a patient&#39;s vasculature. In some embodiments, the needle hub  40  may then be retracted in a proximal direction to retract the needle  42  from the vasculature. In some embodiments, the proximal end of the adapter  46  may be coupled to the needle hub  40  such that retracting the needle hub  40  causes the extendable folds  50  of the tube  48  to expand. In this manner, in some embodiments, the length of the tube  48  may be extended such that at least a portion of the needle  42  may be shielded within tube  48 . In some embodiments, the sharp distal tip of the needle  42  may also be shielded within the tube  48  and housing  32  to protect the user from an accidental needle stick. 
     In some embodiments, securing the adapter  46  to the distal end  36  of the housing  32  may enable the catheter hub  54  to be uncoupled from the adapter  46 . In some embodiments, the catheter  60  may remain within the vasculature of the patient for blood draw or infusion thereafter. In some embodiments, the adapter  46  may be secured proximate to the distal end  36  of the housing  32  such that the adapter  46  at least partially covers the distal end  36 . 
     Referring now to  FIGS. 13 and 18 , in some embodiments, the vascular access device  30  and internal components may be discarded into a trash receptacle  74  after use. In some embodiments, the needle hub  40  may be secured at the proximal end  34  of the housing  32  after retracting the needle  42  from the vasculature. As a result, in some embodiments, the housing  32  may contain the needle hub  40 , needle  42 , and adapter  46  after use. In some embodiments, the catheter hub  54  may be disengaged from the adapter  46  at the distal end of the housing  32  and the housing  32  and internal components may be discarded as a single unit to safely and effectively prevent exposure to blood and pathogens. 
     Referring now to  FIG. 19 , some embodiments of the vascular access device  30  may significantly reduce packaging and product materials associated with prior art devices. For example, in some embodiments, total product length  76  of embodiments of the vascular access device  30  may be reduced by about 3.15 inches relative to prior art assemblies. Similarly, in some embodiments, mass measurements of components of the vascular access device  30  may be likewise reduced. Gross weight of some embodiments of the vascular access device  30  may be reduced by about 2.62 grams. These reductions in size, mass, and weight may be due at least in part to elimination of various prior art components, such as the prior art needle cover, for example. In some embodiments, packaging size and material usage may also be reduced relative to prior art devices. 
     All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.