Needle safety assemblies and methods

Abstract

A needle assembly includes a needle (130) and a needle cap (124) configured to encapsulate a needle tip after use. The needle cap is transitionable between (i) an extended position with respect to the needle cap, where the needle extends through a distal opening of the needle cap such that a distal tip of the needle extends distally beyond the distal end of the needle cap; and (ii) a retracted position with respect to the needle cap, where the distal tip is disposed within the needle cap. An obstructor, rotationally disposed within the needle cap transitions from a non-obstructing state to an obstructing state to prevent the distal tip of the needle from extending distally beyond the distal end of the needle cap in the obstructing state. Tension in a tether extending between a needle hub and the needle cap, enables decoupling of a medical device (114) from the needle cap.

Description

NEEDLE SAFETY ASSEMBLIES AND METHODSPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 572,057, filed March 29, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Accidental needle sticks following a medical procedure, such as accessing a vasculature, continue to present a significant risk of contamination or disease transmission to healthcare workers. Improved safety systems and methods, such as those disclosed herein, are continually needed to reduce the occurrence of accidental needle sticks.SUMMARY

[0003] Disclosed herein is a needle assembly that, according to some embodiments, includes a needle having a distal tip at a distal end of the needle and a needle hub at a proximal end of the needle. A needle cap includes a first passageway extending from a distal opening at a distal end to a proximal opening at a proximal end of the needle cap, where the first passageway is configured for displacement of the needle therethrough. The needle cap is transitionable between (i) a retracted position with respect to the needle, where the needle extends through a distal opening of the needle cap such that a distal tip of the needle extends distally beyond the distal end of the needle cap, and (ii) an extended position with respect to the needle, where the distal tip is disposed within the needle cap. An obstructor is disposed within the needle cap adjacent a distal end of the needle cap, where the obstructor is operatively coupled with the needle such that upon transitioning the needle cap to the extended position, the obstructor is transitioned from a non-obstructing state to an obstructing state. In the nonobstructing state, the needle is allowed to extend distally beyond the distal end of the needle cap, and in the obstructing state, the needle is prevented from extending distally beyond the distal end of the needle cap.

[0004] In some embodiments, when the needle cap is disposed in the retracted position, the needle hub is coupled with the needle cap via a first snap fit such that the needle cap is retained in the retracted position unless a first separating force is applied between the needlehub and the needle cap, where the first separating force exceeds a first required separation force defined by the first snap fit.

[0005] In some embodiments, the needle assembly further includes a medical device extending distally away from the needle cap, where the needle extends at least partially through the medical device when the needle cap is disposed in the retracted position.

[0006] In some embodiments, the medical device includes a catheter assembly including a catheter tube extending distally away from a catheter hub, where the needle cap is coupled with the catheter hub, and where the needle is disposed within the catheter tube when the needle cap is disposed in the retracted position.

[0007] In some embodiments, the needle cap is coupled with the medical device via a second snap fit such that separation of the needle cap from the catheter hub is prevented unless a second separating force is applied between the catheter hub and the needle cap and, the second separating force exceeds a second required separation force defined by the second snap fit. In some embodiments, the second required separation force is greater than the first required separation force.

[0008] In some embodiments, the obstructor includes a second passageway configured for displacement of the needle therethrough, where the second passageway is aligned with the first passageway when the obstructor is in the non-obstructing state, and where the second passageway is not aligned with the first passageway when the obstructor is in the obstructing state.

[0009] In some embodiments, the assembly further includes a tether defining a tether proximal end and a tether distal end, where the tether is coupled with the needle hub at the tether proximal end and operatively coupled with the obstructor at the tether distal end. In some embodiments, the tether is disposed in a slackened state within a tether chamber of the needle hub when the needle is disposed in the extended position.

[0010] In some embodiments, the obstructor is rotatable between the non-obstructing state and the obstructing state, and a tension of the tether causes rotation of the obstructor from the non-obstructing state to the obstructing state. In some embodiments, the second passageway is rotationally mis-aligned with the first passageway in the obstructing state.

[0011] In some embodiments, the needle cap defines a longitudinal axis and the obstructor rotates about a transverse axis of rotation oriented perpendicular to the longitudinal axis.

[0012] In some embodiments, the obstructor includes a spherical shape defining a spherical outside surface, the needle cap includes an obstructor chamber defining a chamber wall, and the obstructor is disposed within the obstructor chamber.

[0013] In some embodiments, the obstructor includes first and second recesses extending inward from the spherical outside surface, the first and second recesses disposed on opposite sides of the obstructor coincident with the transverse axis of rotation. The needle cap includes first and second protrusions extending inward into the obstructor chamber, where the first and second protrusions are disposed on opposite sides of the obstructor chamber coincident with the transverse axis of rotation, and where the first and second protrusions are disposed within the first and second recesses, respectively.

[0014] In some embodiments, the obstructor includes a third protrusion extending outward from the spherical outside surface along a lateral axis that is substantially perpendicular to the transverse axis and the second passageway, and the obstructor chamber includes a slot extending through the chamber wall. The slot is configured to receive the third protrusion such that the third protrusion displaces along the slot when the obstructor rotates from the non-obstructing state toward the obstructing state. In some embodiments, the slot is in communication with the distal opening such that the third protrusion exits the slot and enters the distal opening when the obstructor rotates to the obstructing state. In some embodiments, the slot and the third protrusion are correspondingly sized to define an interference fit so that, once the third protrusion enters the distal opening, the third protrusion is inhibited from reentering the slot.

[0015] Also disclosed herein is a method of encapsulating a distal tip of a needle within a needle cap that, according to some embodiments, includes separating the needle cap from a needle hub by applying a first separating force in excess of a first required separation force between the needle cap and the needle hub, where the needle cap is coupled with the needle hub via a first snap fit. The method further includes extending the needle cap distally along the needle away from the needle hub such that a tether extending between the needle cap and the needle hub is transitioned from a slackened state to an extended state, where (i) the needleextends through a first passage way and a distal opening of the needle cap when the tether is disposed in the slackened state, and (ii) the distal tip is extracted from the distal opening and disposed within the needle cap when the tether is transitioned to the extended state. The method further includes applying a first tension to the tether in the extended state, where (i) the tether is operatively coupled with an obstructor at a distal end of the tether, (ii) applying the first tension to the tether causes the obstructor to transition from a non-obstructing state to an obstructing state, and (iii) the distal tip of the needle is constrained within the needle cap when the obstructor is transitioned to the obstructing state.

[0016] In some embodiments of the method, the obstructor includes a second passageway configured for displacement of the needle therethrough, where the second passageway is aligned with the first passageway when the obstructor is in the non-obstructing state, and where the second passageway is not aligned with the first passageway when the obstructor is in the obstructing state. In some embodiments of the method, the obstructor is rotatable between the non-obstructing state and the obstructing state, and applying the first tension to the tether causes rotation of the obstructor from the non-obstructing state to the obstructing state.

[0017] In some embodiments of the method, the obstructor includes a protrusion extending outward from an outside surface of the obstructor, and the needle cap includes a slot extending radially outward from the distal opening. In such embodiments, the protrusion is disposed within the slot when the obstructor is disposed in the non-obstructing state, and the protrusion is disposed within the distal opening when the obstructor is transitioned to the obstructing state. In some embodiments of the method, the slot and the protrusion are correspondingly sized to define an interference fit so that once the protrusion is disposed within the distal opening, the protrusion is inhibited from reentering the slot.

[0018] In some embodiments of the method, extending the needle cap distally along the needle away from the needle hub includes retracting the needle from a medical device coupled with the needle cap, where the medical device is coupled with the needle cap via a second snap fit. In such embodiments the method may further decoupling the medical device from the needle cap by applying a second separating force in excess of a second required separation force between the needle cap and the medical device, wherein second required separation force is greater than the first required separation force.

[0019] Also disclosed herein is a vascular access device assembly that, according to some embodiments, includes a needle assembly coupled with a medical device. The needle assembly includes a needle having a distal tip at a distal end of the needle and a needle hub at a proximal end of the needle and a needle cap that includes a first passageway extending from a distal opening at a distal end to a proximal opening at a proximal end of the needle cap, where the first passageway is configured for displacement of the needle therethrough. The needle cap is transitionable between (i) a retracted position with respect to the needle, where the needle extends through a distal opening of the needle cap such that a distal tip of the needle extends distally beyond the distal end of the needle cap; and (ii) an extended position with respect to the needle, where the distal tip is disposed within the needle cap. The medical device includes a housing coupled with the needle cap, where the needle extends at least partially through the housing when the needle cap is disposed in the retracted position.

[0020] In some embodiments of the device assembly, when the needle cap is disposed in the retracted position, the housing is coupled with the needle hub via a first snap fit such that needle cap is retained in the retracted position unless a first separating force is applied between the housing and the needle hub, where the first separating force exceeds a first required separation force defined by the first snap fit.

[0021] In some embodiments of the device assembly, the housing is coupled with the needle cap via a second snap fit such that the needle cap decouples from housing when a second separating force is applied directly between the housing and the needle cap, where the second separating force exceeds a default second required separation force defined by the second snap fit. In some embodiments of the device assembly, the default second required separation force is greater than the first required separation force.

[0022] In some embodiments of the device assembly, the needle assembly further includes a tether defining a tether proximal end and a tether distal end, and the tether is coupled with the needle hub at the tether proximal end and coupled with the needle cap at the distal end.

[0023] In some embodiments of the device assembly, the tether is operatively coupled with the second snap fit such that the needle cap decouples from housing when a third separating force is applied between the housing and the needle hub via the tether, where the third separating force is less than the default second required separation force.

[0024] In some embodiments of the device assembly, the tether is operatively coupled with a deflectable member of the needle cap such that tension in the tether deflects the deflectable member, thereby allowing the third separating force to decouple the needle cap from the housing.

[0025] In some embodiments of the device assembly, the needle assembly includes an obstructor disposed within the needle cap adjacent a distal end of the needle cap, the obstructor operatively coupled with the needle such that upon transitioning the needle cap to the extended position, the obstructor is transitioned from a non-obstructing state to an obstructing state, where the distal tip of the needle is (i) allowed to extend distally beyond the distal end of the needle cap in the non-obstructing state, and (ii) prevented from extending distally beyond the distal end of the needle cap in the obstructing state.

[0026] In some embodiments of the device assembly, the obstructor is operatively coupled with the tether such that tension in the tether transitions the obstructor from the nonobstructing state to the obstructing state.

[0027] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0028] FIG. 1 illustrates an exemplary vascular access system, according to some embodiments.

[0029] FIG. 2 illustrates the vascular access system of FIG. 1 in an extended and separated state, according to some embodiments.

[0030] FIG. 3 illustrates a detailed cross-sectional side view of a portion of the vascular access system of FIG. 1, according to some embodiments.

[0031] FIG. 4A is a detailed perspective view of obstructor of a needle cap of a needle assembly of the vascular access system of FIG. 1, according to some embodiments.

[0032] FIG. 4B is a detailed cross-sectional view of a housing of the needle cap of the needle assembly of the vascular access system of FIG. 1, according to some embodiments.

[0033] FIG. 4C is a detailed cross-sectional view of an assembly of the obstructor of FIG. 4A and the housing of FIG. 4B, according to some embodiments.

[0034] FIG. 5 A is a detailed cross-sectional view of the assembly of FIG. 4C with the obstructor disposed in a non-obstructing state, according to some embodiments.

[0035] FIG. 5B is a detailed cross-sectional view of the assembly of FIG. 5 A with the obstructor disposed in an obstructing state, according to some embodiments.

[0036] FIG. 6A illustrates a second embodiment of a vascular access system in a first state of separation, according to some embodiments.

[0037] FIG. 6B illustrates the vascular access system of FIG. 6A in a final state of separation, according to some embodiments.

[0038] FIG. 7A is a detailed illustration of the needle cap of the vascular access system of FIG. 6 A, according to some embodiments.

[0039] FIG. 7B is a detailed illustration of the needle cap of FIG. 7A coupled with a housing of a medical device of the vascular access system of FIG. 6A, according to some embodiments.

[0040] FIG. 8 is a blook diagram of a method of encapsulating a distal tip of a needle within a needle cap after use of the needle during a vascular access procedure, according to some embodiments.DESCRIPTION

[0041] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0042] 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 todistinguish 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.

[0043] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0044] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end nearest a practitioner during use, and the distal end of a medical device is the end or portion nearest a patient during use.

[0045] 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. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” may be recited with respect to a feature, it is understood that the feature can have a precisely straight configuration.

[0046] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for properoperation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0047] FIG. 1 illustrates an exemplary vascular access system 100 composed of multiple devices. In this example, the vascular access system 100 includes a medical device (e.g., the catheter assembly 112) and a needle assembly 120. The catheter assembly 112 includes a catheter 114, having catheter tube 116 and a catheter hub 118. Also illustrated in FIG. l is a protection cap 122 positioned above the catheter assembly 112. The protection cap 122 may cover an access port which provides access to a lumen of the catheter 114. Medical devices other than the catheter assembly 112 may also be employed with the vascular access system 100, such as an introducer, a guidewire device, and the like.

[0048] The needle assembly 120 includes a needle cap 124 and a needle hub 126. The needle cap 124 is configured such that it will contain a needle tip 128 of a needle 130 when the needle 130 is extracted from the catheter 114 (or more generally, the medical device). The needle hub 126 is securely attached to the needle 130 and provides for manipulation of the needle 130 and placement of the catheter 114 within the vasculature of a patient. The needle hub 126 may include grips 132 which allow for secure gripping of the needle hub 126 and maneuvering of the needle 130. In addition, the needle hub 126 may include a plug 134.

[0049] The needle cap 124 is coupled with the needle hub 126 via a first snap fit 127. The first snap fit 127 defines a first required separation force such that the decoupling including separation of the needle cap 124 from the needle hub 126 requires applying a first separating force between the needle cap 124 and the needle hub 126 that exceeds the first required separation force. In other words, the needle cap 124 remains coupled with the needle hub 126 unless or until a user applies the applies the first separating force between the needle cap 124 and the needle hub 126.

[0050] The catheter hub 118 is coupled with the needle cap 124 via a second snap fit 129. The second snap fit 129 defines a second default required separation force such that,according to one embodiment, decoupling (including separation) of the catheter hub 118 from the needle cap 124 requires applying a second separating force between the catheter hub 118 and the needle cap 124 that exceeds the second required default separation force. In other words, according to the one embodiment, the catheter hub 118 remains coupled with needle cap 124 unless or until a user applies the second separating force between the catheter assembly 112 and the needle cap 124. In such embodiments, the second required default separation force is greater than the first required separation force. As such, when a separating force is applied between the catheter assembly 112 and the needle hub 126, the needle cap 124 is separated from the needle hub 126 before the catheter hub 118 is separated from the needle cap 124 because the second required default separation force is greater than the first required separation force.

[0051] Referring now to FIG. 2, the vascular access system 100 is illustrated in an exploded view. As with FIG. 1, the catheter assembly 112 and needle assembly 120 are shown. As discussed above, the catheter assembly 112 includes a catheter 114 for placement within the vascular system of a patient. The catheter assembly 112 includes the catheter tube 116 of the catheter 114 and a catheter hub 118 of the catheter 114. The catheter hub 118 is configured such that the catheter 114 can be attached to further medical devices or tubing, such as for the administration of fluids to the patient. In that regard, the illustrated catheter assembly 112 also includes a protection cap 122 which covers an access port that provides access to a lumen of the catheter 114.

[0052] Also illustrated in FIG. 2 is the needle hub 126 in a position in which the needle 130 has been fully extracted from the catheter 114. As mentioned above, the needle hub 126 as illustrated includes grips 132 for use in extracting and manipulating the position of the needle 130. The needle hub 126 is also closed at its proximal end by the plug 134.

[0053] Extending between the needle cap 124 and the needle hub 126 is a tether 136 in an extended state. The length of the tether 136 is selected such that when the needle cap 124 is separated from the needle hub 126, the needle 130 is extracted from the catheter 114 so that the needle tip 128 of needle 130 is encapsulated within the needle cap 124. Although not shown, the tether 136 is disposed in a slacked state when the needle cap 124 coupled with the needle hub 126 as shown in FIG. 1. The tether 136 may be folded in an accordion configuration, may be straight, or take any other desired configuration.

[0054] As illustrated in FIG. 2, the needle tip 128 is disposed within the needle cap 124. The tether 136 is in the extended state between the needle cap 124 and the needle hub 126. Thus, the needle 130 is prevented from being pulled proximally out of the needle cap 124. Interior structures and components of the needle cap 124 cooperate with the needle 130 to prevent the needle 130 from subsequently extending distally out of the needle cap 124 as further described below.

[0055] In use, the needle cap 124 is first decoupled and separated from the needle hub 126 by applying the first separating force between the catheter assembly 112 and the needle hub 126. Thereafter, the needle cap 124 is displaced away from the needle hub 126 during which displacement the tether 136 is transitioned from the slackened state of FIG. 1 to the extended state of FIG. 2, and the needle 130 is extracted from the catheter 114. After that, the catheter hub 118 is decoupled and separated the needle cap 124 by applying the second separating force between the catheter assembly 112 and the needle hub 126 where tension in the tether 136 transfers the second separating force from the needle hub 126 to the needle cap 124. Note that further details regarding needle assemblies for encapsulating a needle tip within a needle cap can be found in U.S. Pat. No. 9,056,188 which is incorporated in its entirety into this application.

[0056] FIGS. 3-5B illustrate various views of a portion of the vascular access system 100 including second embodiments of the needle assembly 320 and the needle cap 324, each of which can, in certain respects resemble components and features of the needle assembly 120 and the needle cap 124 of FIGS. 1, 2. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the needle assembly 120 and the needle cap 124 including related components shown in FIGS. 1, 2 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the needle assembly 320 and the needle cap 324 of FIGS. 3-5B. Any suitable combination of the features, and variations of the same, described with respect to the needle assembly 120 and the needle cap 124 and components illustrated in FIGS. 1, 2 can be employedwith the needle assembly 320 and the needle cap 324 of FIGS. 3-5B, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

[0057] FIG. 3 illustrates a detailed cross-sectional view of a portion of the vascular access system 100. The needle assembly 320 includes the grip 332 which may extend vertically upward away from the needle hub 326. The grip 332 may define a generally flat shape which be advantageous when the vascular access system 100 is packaged within a pouch. The needle cap 324 generally defines an outside cross-section dimension (e.g., a diameter) that is less than an outside cross-section dimension (e.g., a diameter) of the catheter hub 118, which can be advantageous when the vascular access system 100 is packaged within a pouch and may include a reduced volume of material with respect to the needle cap 124. The second snap fit 329 may include corresponding interference members (e.g., a protrusion and a recess) that are located within an interior of the catheter hub 118. The needle cap 324 further includes an obstructor 340 that is operatively coupled with the tether 336 shown in the slackened state. The obstructor 340 is configured to transition from a non-obstructing state of FIG. 3 to an obstructing state in response to applying a first tension to the tether 336 as further described below. The obstructor 340 may be formed of a plastic material via the plastic injection molding process.

[0058] FIG. 4A is a detailed perspective view of the obstructor 340. The obstructor 340 may generally define a special shape including a spherical outer surface 444. An obstructor passageway 445 extends through the obstructor 340 along a longitudinal access 441 and is configured to receive the needle 330 therethrough. First and second recesses 446A, 446B extend inward from the spherical outer surface 444 on front and back sides of the obstructor 340, respectively. The first and second recesses 446A, 446B are disposed coincident with a transverse axis 442 which defines an axis of rotation for the obstructor 340. In some embodiments, the first and second recesses 446A, 446B may extend inward so as to communicate with the obstructor passageway 445. A tether engagement member 447 extends outward from the spherical outer surface 444 and is configured to attach to the tether 336, such that a tension of the tether 336 pulls on the tether engagement member 447 to cause rotation of the obstructor 340. The tether engagement member 447 includes an obstructor stop surface 448. An obstructor protrusion 449 extends away from the spherical outer surface 444 along alateral axis 443. The longitudinal axis 441, the transverse axis 442 and the lateral axis 443 are each oriented mutually perpendicular to each other.

[0059] FIG. 4B is a detailed cross-sectional view of a housing 450 of the needle cap 324. In some embodiments, the housing 450 may be formed of front housing portion and a back housing portion that are individually formed and then coupled together. Each of the front and back housing portions may be formed of a plastic material via the plastic injection molding process and the front and back housing portions may be coupled with each other via any suitable method for joining plastic parts, such as adhesive bonding, ultrasonic welding, solvent bonding, and the like. The front and back housing portions are complementary to each other and may also be symmetrical to each other. FIG. 4B illustrates the back housing portion 450B of the housing 450, and as such, the features and components of the back housing portion 450B shown in FIG. 4B and described therewith may also be included with the front housing portion (not shown).

[0060] The back housing portion 450B includes a needle passageway 451 extending along a longitudinal axis 441 A of the back housing portion 450B, where the needle passageway 451 is configured to accommodate passage of the needle 330 therethrough. The needle passageway 451 is further configured to encapsulate the needle tip 128 therein.

[0061] The back housing portion 450B includes an obstructor chamber 452 configured to receive the obstructor 340 therein and enable rotation of the obstructor 340 therein. The obstructor chamber 452 includes a chamber wall 453 defining an inside surface 453A. Some portions of the inside surface 453 A may include a spherical shape to correspond to the spherical outer surface 444 of the obstructor 340. The back housing portion 450B includes a tether passageway 455 configured to slidably receive the tether 336 therethrough. The tether passageway 455 communicates with the obstructor chamber 452 and may be disposed tangent to a spherical portion of the inside surface 453 A.

[0062] A distal opening 456 extends through the chamber wall 453 at a distal end of the back housing portion 450B. The distal opening 456 is disposed in line with the longitudinal axis 441 A so that the distal opening 456 and the needle passageway 451 are in alignment. A slot 459 also extends through the chamber wall 453. The slot 459 extends along a spherical portion of the chamber wall 453 and communicates with the distal opening 456. An end of theslot 459 opposite the distal opening 456 defines a first housing stop surface 458A and a portion of the chamber wall 453 defines a second housing stop surface 458B.

[0063] An axial protrusion 456B extends inward away from the chamber wall 453 and into the obstructor chamber 452. The axial protrusion 456B is configured engage the second recess 446B so that the obstructor 340 rotates about the axial protrusion 456B. Of course, a corresponding axial portion extends inward for a chamber wall of the front portion of the housing 450 and engages the first recess 446A of the obstructor 340.

[0064] FIG. 4C shows a partial assembly of needle cap 324 with the obstructor 340 disposed within the obstructor chamber 452 of the back housing portion 450B. The axil protrusion 456B is disposed within the second recess 446B. The obstructor 340 is rotated to the obstructing state so that the obstructor passageway 445 is oriented orthogonal to the needle passageway 451 of the housing 450. As such, the needle 330 is prevented from passing through the obstructor 340 and the distal opening 456 and is therefore, constrained within the needle passageway 451. With the obstructor 340 rotated to the obstructing state, the obstructor stop surface 448 is in contact with the second housing stop surface 458B, thereby preventing further rotation of the obstructor 340 in the counter clockwise direction as illustrated. Again with the obstructor 340 rotated to the obstructing state, the obstructor protrusion 449 is displaced out of the slot 459 and disposed within distal opening 456. The slot 459 defines an internal width 459A oriented perpendicular to the page and the obstructor protrusion 449 defines an external width 449A also oriented perpendicular to the page. The internal width 459A and external width 449A are configured to define an interference relationship, such that once the obstructor protrusion 449 exits the slot 459 and enters distal opening 456, the obstructor protrusion 449 is prevented from exiting the distal opening 456 and reentering the slot 459. In other words, once the obstructor 340 is transitioned to obstructing state, the obstructor 340 is prevented from transitioning out of the obstructing state toward the non-obstructing state.

[0065] FIG. 5A illustrates a cross-sectional side view of the needle cap 324 with the obstructor 340 disposed in the non-obstructing state, where the needle cap 324 is coupled with the catheter hub 118 and the needle hub 326. The needle 330 extends along the needle passageway 451 and through the obstructor passageway 445 and the distal opening 456. The tether 336 is disposed within and extends along the tether passageway 455 in the slackened state. The tether 336 is attached to the obstructor 340 at a location on the outer spherical surface 444 such that proximal displacement of the tether 336 with respect to the needle cap 324 causethe obstructor 340 to rotate away from the non-obstructing state. In one exemplary embodiment, the tether 336 includes a loop 536 that engages (e.g., loops over) the tether engagement member 447. Of course other attachment methods are contemplated.

[0066] FIG. 5B illustrates the cross-sectional side view of the needle cap 324 with the obstructor 340 disposed in the obstructing state, where the needle cap is decoupled and separated from the needle hub 326 such that the needle 330 is extracted from the catheter 114 (see FIG.2). In accordance with separation of the needle hub 326 from the needle cap 324, the tether 336 is proximally displaced along the tether passageway 455 with respect to the position of the tether 336 shown in FIG. 5 A. The proximal displacement of the tether 336 in combination with a tension in the tether 336, has caused the obstructor 340 to rotate approximately 90 degrees from the non-obstructing state to the obstructing state, thereby encapsulating the distal tip 128 within the needle cap 324 and preventing the needle 330 from distally exiting the needle cap 324.

[0067] FIGS. 6A-7B illustrate another embodiment of a vascular access system 600 that can, in certain respects resemble components and features of the vascular access system 100. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the vascular access system 100 including related components shown in FIGS. 1-5B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the vascular access system 600 of FIGS. 6A-7B. Any suitable combination of the features, and variations of the same, described with respect to the vascular access system 100 and components illustrated in FIGS. 1-5B can be employed with the vascular access system 600 of FIGS. 6A-7B, and vice versa.

[0068] FIG. 6A illustrates the vascular access system 600 in a first state of separation, and FIG. 6B illustrates the vascular access system 600 in a final state of separation. The description that follows makes reference to both FIGS. 6 A, 6B. The vascular access system 600 is initially disposed in a fully coupled state, similar to the state of the vascular access system 100 as illustrated in FIG. 1. The vascular access system 600 generally includes avascular device assembly 612 (or medical device) and a needle assembly 620. The vascular access system 600 is generally configured such that transitioning the vascular access system 600 from the first state of separation to the final state of separation is prevented unless the vascular access system 600 is first transitioned from the fully coupled state to the first state of separation.

[0069] The vascular device assembly 612 may include any medical device utilized in conjunction with a needle during a vascular access procedure, such as a device configured for handling a guidewire 20 as shown, a catheter, an introducer, a dilator or the like. The vascular device assembly 612 includes a main housing 613. The vascular device assembly 612 is configured to receive a needle 630 through the main housing 613 such that the needle 630 extends distally beyond the main housing 613 when the vascular access system 600 is disposed in the fully coupled state (see FIG. 1).

[0070] The needle assembly 120 includes a needle cap 624 and a needle hub 626 coupled with the needle 630. The needle cap 624 is configured to contain a needle tip of the needle 630 when the needle 630 is proximally extracted from the vascular device assembly 612. The needle hub 626 is securely attached to the needle 630 and provides for manipulation of the needle 630 during use. The needle hub 626 may include grips 632 which allow for secure gripping of the needle hub 626 and maneuvering of the needle 630. In addition, the needle hub 626 is configured to couple with another medical device, such as a syringe 10, for example.

[0071] In the fully coupled state, the main housing 613 is directly coupled with the needle hub 626. The main housing 613 may be coupled with the needle hub 626 via a first snap fit. The first snap fit defines a first required separation force such that decoupling including separation of the needle cap 624 from the needle hub 626 requires applying a first separating force between the main housing 613 and the needle hub 626 that exceeds the first required separation force. In other words, the main housing 613 remains coupled with the needle hub 626 unless or until a user applies the first separating force between the main housing 613 and the needle hub 626. In the fully coupled state and in the first state of separation, main housing 613 the directly coupled with the needle cap 624. In some embodiments, when main housing 613 the directly coupled with the needle cap 624, the needle cap 624 is disposed within an interior of the main housing 613.

[0072] As illustrated in FIG. 6B, a tether 636 extends between the needle cap 624 and the needle hub 626, such that the tether 636 is attached to the needle hub 626 at a proximal end of the tether 636 and the tether 636 is operatively coupled with the needle cap 624 at the distal end of the tether 636. The length of the tether 636 is selected such that, when the needle cap 624 is separated from the needle hub 626, the needle 630 is extracted from the main housing 613 as illustrated FIGS. 6A, 6B, the distal tip of the needle 630 is disposed within the needle cap 624. The tether 636 may take any form, such as a flat ribbon, a wire, or cable, for example. The tether 636 is illustrated in an extended state in FIGS. 6A, 6B, which prevents the needle 630 from being pulled proximally out of the needle cap 624. Although not shown, when the vascular access system 600 is disposed in the fully coupled state, the tether 636 is disposed in a slackened state which may include a folded accordion configuration, coiled configuration or any other desired configuration.

[0073] The main housing 613 may be coupled directly with the needle cap 624 via a second snap fit. The second snap fit may define a second default required separation force such that, decoupling of the main housing 613 from the needle cap 624 requires applying a second separating force between the catheter hub 118 and the needle cap 124 that exceeds the second required default separation force, where the second separating force is applied directly to the needle cap 124, i.e., not by way of the tether 636. In the illustrated embodiment, the tether 636 may be operatively coupled with the needle cap 624 such that tension in the tether 636 can affect the operation of the second snap fit. More specifically, the tension in the tether 636 may interact with the second snap fit such that when a third separating force is applied to the needle cap 624 by way of the tether 636, the second snap fit may be overcome by the third separating force, where the third separating force is less than the second default required separation force.

[0074] In use, the main housing 613 is first decoupled from the needle hub 126 by applying the first separating force between the main housing 613 and the needle hub 126. Thereafter, the main housing 613 together with the needle cap 624 is displaced away from the needle hub 626. During such displacement, the tether 636 is transitioned from the slackened state to the extended state, and the needle 630 is extracted from the main housing 613. After that, the main housing 613 is decoupled and separated from the needle cap 624 by applying the third separating force between the main housing 613 and the needle hub 626 where tension in the tether 636 transfers the third separating force from the needle hub 626 to the needle cap 624.

[0075] FIGS. 7A, 7B illustrate exemplary components and features of an exemplary second snap fit configuration that enable the tension in the tether 636 to decouple the needle cap 624 from the main housing 613 via the third separating force. It is noted that the exemplary second snap fit configuration shown and descried is only one configuration of several configurations that could be incorporated by one of ordinary skill to define the function described above, which several configurations are included in this disclosure.

[0076] FIG. 7A is a perspective view of the needle cap 624 including a deflectable member 710 according to one exemplary embodiment, where the deflectable member 710 defines a first portion of the second snap fit. Also shown is a tether attachment member 705 for the tether 636. The deflectable member 710 is located at the proximal end of the needle cap 624. The deflectable member 710 extends away from a proximal end of the needle cap 624 at a left lateral side, and the deflectable member 710 further extends across the proximal end of the needle cap 624 from the left side toward the right side, as shown. The deflectable member 710 is configured such that a right portion 710A deflects downward in response to a downward directed force 701 applied thereto.

[0077] FIG. 7B is a proximal end view illustration of the needle cap 624 coupled with the main housing 613, where the needle cap 624 is disposed within an interior of the main housing 613 as also shown in FIG. 6A. The needle cap 624 and the main housing 613 are oriented in FIG. 7B such that the distal direction faces into the page and the proximal direction faces out of the page. The deflectable member 710 is operatively engaged with a non- deflectable member 711 of the main housing 613, where the non-deflectable member 711 defines a corresponding second portion of the second snap fit. The operative engagement of the deflectable member 710 with the non-deflectable member 711 inhibits separation of the needle cap 624 coupled with the main housing 613. More specifically, the operative engagement inhibits proximal displacement of the needle cap 624 with respect to the main housing 613. From a structural perspective, a portion of the non-deflectable member 711 is disposed proximal the right portion 710A of the deflectable member 710. The operative engagement of the non-deflectable member 711 with the deflectable member 710 defines the second default required separation force. In other words, the operative engagement prevents decoupling of the needle cap 624 from the main housing 613 unless a second separating force exceeding the second default required separation force is applied between the needle cap 624and the main housing 613, where the second separating force is applied directly to the needle cap 624.

[0078] The non-deflectable member 711 is configured such that the deflection of the right portion 710A as described above in relation to FIG.7 A reduces the operative engagement of the non-deflectable member 711 with the deflectable member 710. As such, a reduced operative engagement provides for decoupling of the needle cap 624 from the main housing 613 when the third separating force is applied to the needle cap 624 by way of the tether 636.

[0079] FIG. 7B further illustrates that the tether 636 coupled with the needle cap 624. The distal end 706 of the tether 636 is attached to the tether attachment member 705 and a deflecting portion 707 is draped over the deflectable member 710. The deflecting portion 707 extends along the tether 636 at a location proximal the distal end 706. With the deflecting portion 707 draped over the deflectable member 710, tension of the tether 636 defines the downward directed force 701. By way of summary, a tension of the tether 636 generates the downward directed force 701 on the deflectable member 710 causing the right portion 710A to deflect away from the non-deflectable member 711. The deflection of the right portion 710A reduces the operative engagement, thereby reducing the separating force required to decouple the needle cap 624 from the main housing 613 from the second separating force toward the third separating force.

[0080] In use, with the vascular access system 600 disposed in the first state of separation of FIG. 6A, the user applies the third separating force between the needle hub 626 and the main housing 613 such that the second separating force defines a tension of the tether 636 and the tether 636 transfers the third separating force to the needle cap 624. The tension of the tether 636 reduces the operative engagement of the deflectable member 710 with the non- deflectable member 711 so that the needle hub 626 decouples from the main housing 613 when the third separating force is applied to the needle cap 624 by the tether 636.

[0081] It is noted that at least some components, features and functionalities of the vascular access systems 100 and 600 are not mutually exclusive. In other words, any components, features, and functionalities of the vascular access system 100, that are not inconsistent with operation of the vascular access system 600, may be incorporated into the vascular access system 600 and vice versa. For example, the needle cap 624 of vascular accesssystem 600 may include the components, features, and functionalities of the needle cap 124 as shown in FIGS. 4A-5B.

[0082] FIG. 8 is a blook diagram of a method 800 of encapsulating a distal tip of a needle within a needle cap after use of the needle during a vascular access procedure. The method 800 may include all or any subset of the following steps, actions, operations or processes, according to some embodiments. The method 800 includes decoupling the needle cap from a needle hub by applying a first separating force in excess of a first required separation force between the needle cap and the needle hub (block 810), where the needle cap is coupled with the needle hub via a first snap fit.

[0083] The method 800 further includes extending the needle cap distally along the needle away from the needle hub such that a tether extending between the needle cap and the needle hub is transitioned from a slackened state to an extended state (block 820), where (i) the needle extends through a first passage way and a distal opening of the needle cap when the tether is disposed in the slackened state, and (ii) the distal tip is extracted from the distal opening and disposed within the needle cap when the tether is transitioned to the extended state. In some embodiments of the method 800, extending the needle cap distally along the needle away from the needle hub includes retracting the needle from a catheter tube of a catheter assembly, where the catheter assembly is coupled with the needle cap via a second snap fit.

[0084] The method 800 further includes applying a first tension to the tether in the extended state to cause an obstructor to transition from a non-obstructing state to an obstructing state (block 830). The tether is operatively is operatively coupled with an obstructor at a distal end of the tether, so that applying the first tension to the tether causes the obstructor to transition from a non-obstructing state to an obstructing state, and further causes the distal tip of the needle to be constrained within the needle cap when the obstructor is transitioned to the obstructing state. In some embodiments of the method 800, the obstructor includes a second passageway configured for displacement of the needle therethrough, where (i) the second passageway is aligned with the first passageway when the obstructor is in the non-obstructing state, and (ii) the second passageway is not aligned with the first passageway when the obstructor is in the obstructing state. In some embodiments of the method 800, the obstructor is rotatable between the non-obstructing state and the obstructing state, and applying the firsttension to the tether causes rotation of the obstructor from the non-obstructing state to the obstructing state.

[0085] In some embodiments of the method 800, the obstructor includes a protrusion extending outward from an outside surface of the obstructor, and the needle cap includes a slot extending radially outward from the distal opening. In such embodiments, the protrusion is disposed within the slot when the obstructor is disposed in the non-obstructing state, and the protrusion is disposed within the distal opening when the obstructor is transitioned to the obstructing state. In some embodiments of the method, the slot and the protrusion are correspondingly sized to define an interference fit so that once the protrusion is disposed within the distal opening, the protrusion is inhibited from reentering the slot. As such, the method 800 may further include displacing the protrusion of the obstructor along and out of the slot so that the obstructor is constrained in the obstructing state (block 840).

[0086] In some embodiments of the method 800, extending the needle cap distally along the needle away from the needle hub includes retracting the needle from a medical device coupled with the needle cap, where the medical device coupled with the needle cap via a second snap fit. In such embodiments, the method 800 may further include decoupling the medical device from the needle cap by applying a second separating force in excess of a second required separation force between the needle cap and the medical device (block 850), wherein second required separation force is greater than the first required separation force.

[0087] 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.

Claims

CLAIMSWhat is claimed is:

1. A needle assembly, comprising: a needle including a distal tip at a distal end of the needle and a needle hub at a proximal end of the needle; a needle cap including a first passageway extending from a distal opening at a distal end to a proximal opening at a proximal end of the needle cap, the first passageway configured for displacement of the needle therethrough, wherein the needle cap is transitionable between: a retracted position with respect to the needle, wherein the needle extends through the distal opening of the needle cap such that the distal tip of the needle extends distally beyond the distal end of the needle cap, and an extended position with respect to the needle, wherein the distal tip is disposed within the needle cap; and an obstructor disposed within the needle cap adjacent the distal end of the needle cap, the obstructor operatively coupled with the needle such that upon transitioning the needle cap to the extended position, the obstructor is transitioned from a nonobstructing state to an obstructing state, wherein the distal tip of the needle is: allowed to extend distally beyond the distal end of the needle cap in the nonobstructing state, and prevented from extending distally beyond the distal end of the needle cap in the obstructing state.

2. The needle assembly according to claim 1, wherein, when the needle cap is disposed in the retracted position, the needle hub is coupled with the needle cap via a first snap fit such that the needle cap is retained in the retracted position unless a first separating force is applied between the needle hub and the needle cap, the first separating force exceeding a first required separation force defined by the first snap fit.

3. The needle assembly according to claim 1 or claim 2, further comprising a medical device extending distally away from the needle cap,wherein the needle extends at least partially through the medical device when the needle cap is disposed in the retracted position.

4. The needle assembly according to claim 3, wherein: the medical device includes a catheter assembly including a catheter tube extending distally away from a catheter hub, the needle cap is coupled with the catheter hub, and the needle is disposed within the catheter tube when the needle cap is disposed in the retracted position.

5. The needle assembly according to claim 3 or claim 4, wherein the needle cap is coupled with the medical device via a second snap fit such that separation of the needle cap from the medical device is prevented unless a second separating force is applied between the medical device and the needle cap, the second separating force exceeding a second required separation force defined by the second snap fit.

6. The needle assembly according to claim 5, wherein the second required separation force is greater than the first required separation force.

7. The needle assembly according to any one of the preceding claims, wherein: the obstructor includes a second passageway configured for displacement of the needle therethrough, the second passageway is aligned with the first passageway when the obstructor is disposed in the non-obstructing state, and the second passageway is not aligned with the first passageway when the obstructor is transitioned to the obstructing state.

8. The needle assembly according to claim 7, further comprising a tether defining a tether proximal end and a tether distal end, wherein the tether is: coupled with the needle hub at the tether proximal end, and operatively coupled with the obstructor at the tether distal end.

9. The needle assembly according to claim 8, wherein: the obstructor is rotatable between the non-obstructing state and the obstructing state, andtension of the tether causes rotation of the obstructor from the non-obstructing state to the obstructing state.

10. The needle assembly according to claim 9, wherein the second passageway is rotationally mis-aligned with the first passageway in the obstructing state.

11. The needle assembly according to any one of claims 8-10, wherein the tether is disposed in a slackened state within a tether chamber of the needle hub when the needle cap is disposed in the retracted position.

12. The needle assembly according to any one of claims 9-11, wherein the needle cap defines a longitudinal axis and the obstructor rotates about a transverse axis of rotation oriented perpendicular to the longitudinal axis.

13. The needle assembly according to claim 12, wherein: the obstructor includes a spherical shape defining a spherical outside surface, the needle cap includes an obstructor chamber defining a chamber wall, and the obstructor is disposed within the obstructor chamber.

14. The needle assembly according to claim 13, wherein: the obstructor includes first and second recesses extending inward from the spherical outside surface, the first and second recesses disposed on opposite sides of the obstructor coincident with the transverse axis of rotation, the needle cap includes first and second protrusions extending inward from the chamber wall, the first and second protrusions disposed on opposite sides of the obstructor chamber coincident with the transverse axis of rotation, and the first and second protrusions are disposed within the first and second recesses, respectively.

15. The needle assembly according to claim 14, wherein: the obstructor includes a third protrusion extending outward from the spherical outside surface along a lateral axis that is disposed substantially perpendicular to the transverse axis and the second passageway, the obstructor chamber includes a slot extending through the chamber wall, andthe slot is configured to receive the third protrusion such that the third protrusion displaces along the slot when the obstructor rotates from the non-obstructing state toward the obstructing state.

16. The needle assembly according to claim 15, wherein the slot is in communication with the distal opening of the needle cap such that the third protrusion exits the slot and enters the distal opening of the needle cap when the obstructor rotates to the obstructing state.

17. The needle assembly according to claim 16, wherein the slot and the third protrusion are correspondingly sized to define an interference fit so that once the third protrusion enters the distal opening of the needle cap, the third protrusion is inhibited from reentering the slot.

18. A method of encapsulating a distal tip of a needle within a needle cap, comprising: decoupling the needle cap from a needle hub of the needle by applying a first separating force in excess of a first required separation force between the needle cap and the needle hub, the needle cap coupled with the needle hub via a first snap fit; extending the needle cap distally along the needle away from the needle hub such that a tether extending between the needle cap and the needle hub is transitioned from a slackened state to an extended state, wherein: the needle extends through a first passage way and a distal opening of the needle cap when the tether is disposed in the slackened state, and the distal tip of the needle is extracted from the distal opening of the needle cap and disposed within the needle cap when the tether is transitioned to the extended state; and applying a first tension to the tether in the extended state, wherein: the tether is operatively coupled with an obstructor at a distal end of the tether, applying the first tension to the tether causes the obstructor to transition from a nonobstructing state to an obstructing state, and the distal tip of the needle is constrained within the needle cap when the obstructor is transitioned to the obstructing state.

19. The method according to claim 18, wherein:the obstructor includes a second passageway configured for displacement of the needle therethrough, the second passageway is aligned with the first passageway when the obstructor is in the non-obstructing state, and the second passageway is not aligned with the first passageway when the obstructor is in the obstructing state.

20. The method according to claim 18 or claim 19, wherein: the obstructor is rotatable between the non-obstructing state and the obstructing state, and applying the first tension to the tether causes rotation of the obstructor from the nonobstructing state to the obstructing state.

21. The method according to claim 20, wherein: the obstructor includes a protrusion extending outward from an outside surface of the obstructor, the needle cap includes a slot extending radially outward from the distal opening of the needle cap, the protrusion is disposed within the slot when the obstructor is disposed in the nonobstructing state, and the protrusion is disposed within the distal opening of the needle cap when the obstructor is transitioned to the obstructing state.

22. The method according to claim 21, wherein the slot and the protrusion are correspondingly sized to define an interference fit so that once the protrusion is disposed within the distal opening of the needle cap, the protrusion is inhibited from reentering the slot.

23. The method according to claim 22, further comprising displacing the protrusion along and out of the slot so that the obstructor is constrained in the obstructing state.

24. The method according to any one of claims 18-23, wherein extending the needle cap distally along the needle away from the needle hub includes retracting the needle from a medical device coupled with the needle cap, the medical device coupled with the needle cap via a second snap fit.

25. The method according to claim 24, further comprising decoupling the medical device from the needle cap by applying a second separating force between the needle cap and the medical device in excess of a second required separation force defined by the second snap fit, wherein the second required separation force is greater than the first required separation force.

26. A vascular access device assembly, comprising: a needle assembly, comprising: a needle including a distal tip at a distal end of the needle and a needle hub at a proximal end of the needle; a needle cap including a first passageway extending from a distal opening at a distal end of the needle cap to a proximal opening at a proximal end of the needle cap, the first passageway configured for displacement of the needle therethrough; wherein the needle cap is transitionable between: a retracted position with respect to the needle, wherein the needle extends through the distal opening of the needle cap such that the distal tip of the needle extends distally beyond the distal end of the needle cap, and an extended position with respect to the needle, wherein the distal tip of the needle is disposed within the needle cap; and a medical device including a housing coupled with the needle cap, wherein the needle extends at least partially through the housing when the needle cap is disposed in the retracted position.

27. The device assembly according to claim 26, wherein, when the needle cap is disposed in the retracted position, the housing is coupled with the needle hub via a first snap fit such that needle cap is retained in the retracted position unless a first separating force is applied between the housing and the needle hub, the first separating force exceeding a first required separation force defined by the first snap fit.

28. The device assembly according to claim 27, wherein the housing is coupled with the needle cap via a second snap fit such that the needle cap decouples from housing when a second separating force is applied directly between the housing and the needle cap, the second separating force exceeding a default second required separation force defined by the second snap fit.

29. The device assembly according to claim 28, wherein the default second required separation force is greater than the first required separation force.

30. The device assembly according to claim 29, wherein the needle assembly further comprises a tether defining a tether proximal end and a tether distal end, and the tether is: coupled with the needle hub at the tether proximal end, and coupled with the needle cap at the distal end.

31. The device assembly according to claim 30, wherein the tether is operatively coupled with the second snap fit such that the needle cap decouples from housing when a third separating force is applied between the housing and the needle hub via the tether, the third separating force less than the default second required separation force.

32. The device assembly according to claim 31, wherein the tether is operatively coupled with a deflectable member of the needle cap such that tension in the tether deflects the deflectable member, thereby allowing the third separating force to decouple the needle cap from the housing.

33. The device assembly according to claim 32, wherein the needle assembly includes an obstructor disposed within the needle cap adjacent the distal end of the needle cap, the obstructor operatively coupled with the needle such that upon transitioning the needle cap to the extended position, the obstructor is transitioned from a non-obstructing state to an obstructing state, wherein the distal tip of the needle is: allowed to extend distally beyond the distal end of the needle cap in the non-obstructing state, and prevented from extending distally beyond the distal end of the needle cap in the obstructing state.

34. The device assembly according to claim 33, wherein obstructor is operatively coupled with the tether such that tension in the tether transitions the obstructor from the nonobstructing state to the obstructing state.

Images