CATHETER ASSEMBLY HOUSING AND RELATED DEVICES AND METHODS

A vascular access device may include a housing, a catheter assembly and a needle assembly. The housing includes a proximal end, a distal end, and a slot extending longitudinally therebetween. The catheter assembly includes a catheter hub and a catheter extending distally from the catheter hub, wherein the catheter and the catheter hub are disposed within the housing. The needle assembly includes a needle hub having a translation feature and an introducer needle having a sharp distal tip. The introducer needle extends distally from the needle hub through the catheter. 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.

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.

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.

DESCRIPTION OF EMBODIMENTS

Referring now toFIGS. 1-4, in some embodiments, a vascular access device30may include a housing32extending along a longitudinal axis and having a proximal end34and a distal end36. In some embodiments, the housing32may 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 housing32may include an elongate barrel shape or another suitable shape.

In some embodiments, the grip element37may be disposed towards the distal end36of the housing32to accommodate a user's grasp. In some embodiments, the grip element37may extend laterally from opposing sides of the housing32. In these and other embodiments, the grip element37may include one or more textured surfaces to facilitate the user's grip.

In some embodiments, a removable barrier38may be coupled to the distal end36of the housing32to maintain sterility of internal components. In some embodiments, the removable barrier38may be disposable and may be coupled to the housing32via an adhesive, press fit, or other suitable mechanism. In some embodiments, for example, the removable barrier38may include foil or another material configured to be peeled back or otherwise easily removed by the user. For example, in some embodiments, the removable barrier38may include foil, plastic, paper, composite, or any other suitable disposable material. Some embodiments of the removable barrier38may be coupled to the housing32via a press fit or another suitable mechanism to protect the sterility of internal components. In some embodiments, the removable barrier38may include a pull tab or other feature or device coupled to or integrated with the removable barrier38to facilitate quick and easy removal.

In some embodiments, the housing32may include a lumen39extending along the longitudinal axis between the proximal end34and the distal end36. In some embodiments, the lumen39may include a shape and dimensions to accommodate various internal components. In some embodiments, for example, the vascular access device30may include a needle assembly having a needle hub40and a needle42extending distally therefrom. In some embodiments, the needle hub40may be slidably disposed within the lumen39. In some embodiments, the needle hub40may be coupled to a proximal end of the needle42such that a sharp distal tip of the needle42may extend from the distal end of the housing32to selectively access a patient's vasculature.

In some embodiments, one or more slots44may extend from an interior surface to an exterior surface of the housing32. In some embodiments, the slots44may extend longitudinally along the housing32between the distal end36and the proximal end34.

In some embodiments, the needle assembly may include a translation feature such as one or more tabs45extending outwardly from the needle hub40. In some embodiments, the one or more tabs45may extend through the slots44to enable a user to access the tabs45to translate the needle hub40along the longitudinal axis within the housing32. As illustrated, in some embodiments, the tabs45may extend laterally from opposing sides of the needle hub. Some embodiments of the tabs45may be generally planar or wing-like to facilitate manual manipulation of the tabs45and associated translation of the needle hub40.

In some embodiments, the distal end36of the housing32may include a lock mechanism to secure a position of an adapter46relative to the housing32. In some embodiments, the lock mechanism may include a mechanical locking device or other feature coupled to or integrated with the distal end36of the housing32. For example, in some embodiments, a distal end of the lumen39may include one or more protrusions47, notches, grooves, or other suitable features to engage a corresponding feature of the adapter46. In some embodiments, the lock mechanism may be actuated by adjusting or manipulating a proximal end of the needle hub40by, for example, retracting the needle hub40in a proximal direction and/or laterally rotating the needle hub40within the lumen39.

In some embodiments, the internal components of the housing32may include one or more of the following: the needle assembly, the adapter46including a compressed tube48, and a catheter assembly49. In some embodiments, the compressed tube48may include multiple extendable folds50. In some embodiments, the needle hub40may include a collar52at a distal end of the needle hub40and configured to couple to a proximal end of the adapter46. In some embodiments, the needle42may extend through the collar52. In some embodiments, a vent plug53may be coupled to a proximal end of the needle hub40, as discussed in more detail below.

In some embodiments, the catheter assembly49may include a catheter hub54, which may include a proximal end56, a distal end58, and a lumen extending therethrough. In some embodiments, the catheter assembly49may include a catheter60, which may extend distally from the distal end58of the catheter hub54. In some embodiments, the catheter60may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the proximal end56of the catheter hub54may include a luer connector, such as the female luer connector62illustrated.

In some embodiments, the distal end of the adapter46may include a luer connector64configured to engage a corresponding luer connector62of the catheter hub54. In some embodiments, the distal end of the adapter46may include a male luer connector64configured to engage a corresponding female luer connector62of the catheter hub54. In some embodiments, a septum66and/or a septum actuator68may be disposed within the catheter hub54.

In some embodiments, the needle42may extend from a distal end of the needle hub40. In some embodiments, the needle42may extend through the internal components when the needle hub40is in a ready position. In some embodiments, translating the needle hub40in a distal direction within the housing32may push the internal components distally such that at least a portion of the catheter hub54, the catheter60, and/or the needle42may extend distal to the distal end36of the housing32. In this position, the catheter60may be ready for insertion into the vasculature of a patient.

In some embodiments, a distal end of the compressed tube48may be secured within a distal end of the adapter46. In some embodiments, a proximal end of the compressed tube48may be secured to the collar52and/or distal end of the needle hub40. In some embodiments, the compressed tube48may include silicone, food grade silicone or another suitable material. In some embodiments, the extendable folds50may be corrugated, similar to an expandable straw. In some embodiments, the extendable folds50may be configured such that the extendable folds50contact or are disposed in close proximity to each other when the needle hub40is in the ready position such that the needle hub40contacts the adapter46.

In some embodiments, the extendable folds50may be configured to flatten and separate in response to the needle hub40being retracted within the housing32. In some embodiments, the needle hub40may be longitudinally distanced from the adapter46in the retracted position.

In some embodiments, the compressed tube48may increase in length in response to the needle hub40being retracted within the housing32. In some embodiments, the length of the compressed tube48may increase such that the compressed tube48may shield a length of the needle42within the lumen39. In some embodiments, the extendable folds50may result in the compressed tube48having a greater cross-sectional diameter in the ready position than in the retracted position.

Referring now toFIGS. 5A-5B, in some embodiments, the adapter46may include a catheter hub lock70to prevent or limit rotational movement between the adapter46and the catheter hub54. In some embodiments, the catheter hub lock70may be coupled to or integrated with a distal end of the luer connector64. In some embodiments, the catheter hub lock70may include a protrusion or other feature configured to mechanically engage a corresponding feature such as an aperture72disposed on a proximal end of the catheter hub54. In some embodiments, the protrusion may engage the aperture72in response to rotation of the adapter46relative to the catheter hub54. In some embodiments, the catheter hub lock70may thereby secure a position of the adapter46with respect to the catheter hub54.

Referring now toFIG. 6, in some embodiments, the compressed tube48may be retained within the adapter46such that a distal end of the compressed tube48may be disposed proximal to the luer connector64. In some embodiments, the distal end of the compressed tube48may be coupled to an interior surface of the adapter46via an adhesive, a press fit, or by any other suitable mechanism or device.

Referring now toFIGS. 7A-7B, in some embodiments, one or more slots44may be disposed between the proximal end34and the distal end36of the housing32. In some embodiments, as illustrated herein, the housing32may include an elongate barrel-shaped body. In some embodiments, a grip element37may be coupled to or integrated with the distal end36of the body of the housing32. In some embodiments, a distal end of the slot44may be disposed within or proximate to a proximal end of the grip element37. In some embodiments, the grip element37may thereby provide a distal stop for the translation feature or tab45, for example. In some embodiments, engagement of the translation feature or tab45with the grip element37may provide a snap lock to secure a position of the needle hub40relative to the housing32.

Similarly, in some embodiments, a proximal end of one or more of the slots44may include a snap lock or other mechanism to engage the needle hub40and/or the translation feature or tab45when the needle hub40is in the retracted position. In some embodiments, the snap lock may selectively engage and secure the needle hub40and/or the translation feature or tabs45relative to the housing32. In some embodiments, the slot44may narrow such that the tab45may snap past the narrowing to lock into place relative to the housing32.

In some embodiments, the translation feature or tabs45may be translated in a distal direction to advance the catheter assembly49, the adapter46, and the needle assembly through the housing32. In some embodiments, the tabs45may be translated in a proximal direction along the housing32to retract the needle42through the catheter assembly49and separate the needle hub40from the adapter46.

Referring now toFIGS. 8A-8B, in some embodiments, the needle hub40may include a vent plug53disposed at or near its proximal end. In some embodiments, the vent plug53may be configured to allow air but not fluid to exit the needle hub40. In some embodiments, the vent plug53may include a porous material or membrane.

Referring now toFIGS. 9-18, example embodiments of a method for using a vascular access device30to advance a catheter and shield an introducer needle after use are illustrated.FIGS. 9-13illustrate embodiments of the vascular access device30that include multiple translation features or tabs45.FIGS. 14-18, on the other hand, illustrate embodiments of the vascular access device30that include a single translation feature or tab45.

As shown inFIGS. 9 and 14, some embodiments may include removing and/or discarding a removable barrier38from the distal end36of the housing32. In some embodiments, the vascular access device30may include a needle having a sharp distal tip disposed within the housing32prior to use for safety. As shown inFIGS. 11 and 16, a user may grip the translation feature or tabs45to translate the needle hub40in a distal direction within the housing32. In some embodiments, this may also move the needle, the catheter assembly49, and the adapter46distally within the housing32.

In this manner, in some embodiments, the needle hub40may be distally translated to a ready position such that the sharp distal tip24of the needle42may extend beyond the distal end36of the housing32. In some embodiments, the sharp distal tip24of the needle42may then be manipulated to break tip adhesion such that the sharp distal tip24may penetrate the vasculature. In these and other embodiments, the catheter60may be advanced into the vasculature in response to entry of the needle42into the vasculature. In some embodiments, entry of the catheter60into the vasculature may be confirmed by verifying blood flashback. For example, in some embodiments, blood flashback may flow distally through the needle42and out of a notch in the needle42into a space between the needle42and the catheter60. In some embodiments, blood flashback may flow into a flashback chamber.

Referring now toFIGS. 12 and 17, in some embodiments, the needle42may be removed from the vasculature after blood flashback has been confirmed. In some embodiments, the needle42may be removed by retracting the needle hub40in a proximal direction. In some embodiments, the translation feature or one or more tabs45may be gripped by the user and moved in the proximal direction along the slots44to retract the needle hub40and associated needle42.

In some embodiments, the lock mechanism may be actuated to secure the adapter46at the distal end36of the housing32. 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 adapter46to retain the adapter46. 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 hub40upon retraction of the needle42to retain the needle hub40in the retracted position proximate to the proximal end34of the housing32.

In some embodiments, as discussed previously, the distal end of the adapter46may be secured at the distal end36of the housing32upon insertion of the needle42into a patient's vasculature. In some embodiments, the needle hub40may then be retracted in a proximal direction to retract the needle42from the vasculature. In some embodiments, the proximal end of the adapter46may be coupled to the needle hub40such that retracting the needle hub40causes the extendable folds50of the tube48to expand. In this manner, in some embodiments, the length of the tube48may be extended such that at least a portion of the needle42may be shielded within tube48. In some embodiments, the sharp distal tip of the needle42may also be shielded within the tube48and housing32to protect the user from an accidental needle stick.

In some embodiments, securing the adapter46to the distal end36of the housing32may enable the catheter hub54to be uncoupled from the adapter46. In some embodiments, the catheter60may remain within the vasculature of the patient for blood draw or infusion thereafter. In some embodiments, the adapter46may be secured proximate to the distal end36of the housing32such that the adapter46at least partially covers the distal end36.

Referring now toFIGS. 13 and 18, in some embodiments, the vascular access device30and internal components may be discarded into a trash receptacle74after use. In some embodiments, the needle hub40may be secured at the proximal end34of the housing32after retracting the needle42from the vasculature. As a result, in some embodiments, the housing32may contain the needle hub40, needle42, and adapter46after use. In some embodiments, the catheter hub54may be disengaged from the adapter46at the distal end of the housing32and the housing32and internal components may be discarded as a single unit to safely and effectively prevent exposure to blood and pathogens.

Referring now toFIG. 19, some embodiments of the vascular access device30may significantly reduce packaging and product materials associated with prior art devices. For example, in some embodiments, total product length76of embodiments of the vascular access device30may be reduced by about 3.15 inches relative to prior art assemblies. Similarly, in some embodiments, mass measurements of components of the vascular access device30may be likewise reduced. Gross weight of some embodiments of the vascular access device30may 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.