# Patent

## Title
Needle shielding assemblies and infusion devices for use therewith

## Abstract

A needle assembly includes a needle and a needle shield device. The needle shield device includes an inner shield connectable to at least one a base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority under 35 USC §119(e) from U.S. Provisional Patent Application Ser. Nos. 61/568,074 and 61/692,985, filed on Dec. 7, 2011 and Aug. 24, 2012, respectively, the disclosures of which are incorporated herein by reference in their entirety.


FIELD OF THE INVENTION
The present invention relates generally to needle shielding assemblies, and more particularly, to introducer needle shielding assemblies for use with infusion devices, such as subcutaneous infusion devices used in conjunction with an infusion pump in the infusion of insulin and other medicaments.
BACKGROUND OF THE INVENTION
One mode of insulin infusion treatment for diabetes includes infusion pump therapy via a catheter, needle or other type of cannula. Infusion pumps offer the advantages of continuous infusion of insulin, precision dosing, and programmable delivery schedules. Together, these advantages result in more accurate blood glucose control. In this mode of insulin infusion treatment, the infusion pump remains attached to the user and required doses of insulin are delivered to the user via the pump.
One type of cannula is a catheter, which generally is a tube that can be inserted into the body to permit the administration of fluids. In infusion pump therapy, the types and sizes of the catheter may vary, but generally, the catheter is a thin, flexible tube. In some uses, however, it may be larger and/or rigid.
One type of conventional infusion set is sold as the Quick-Set® infusion set by Medtronic. In such devices, the infusion pump includes a catheter assembly connected to a pump via a tubing set, and a separate insertion device inserts and/or attaches the catheter assembly into to a user via an introducer needle provided as part of the infusion set. The infusion set and insertion device can also be combined, as in the Mio® infusion set sold by Medtronic, which is an “all-in-one” design that combines the infusion set and insertion device into one unit.
A conventional infusion device can include a fluid connector hub, which may be releasably attached to a base that can be secured to a user's skin. An infusion pump supplies fluid to a catheter via the fluid connector hub/base engagement.
With conventional infusion devices, however, there are concerns that, after insertion of the catheter and removal of the insertion device, the introducer needle is exposed and may cause physical damage from a needle stick. There are also concerns over the difficulty of balancing the force required to disconnect the tubing without pulling the catheter from the user's skin versus having enough retention force to secure the infusion components for everyday infusion. Another concern is that there may be a need to design a rotational lock between the fluid connector hub and the base post. Yet another concern is that the separation force needs to be designed such that if a user accidentally snags the extension tubing on an external structure (e.g., a doorknob), the extension tubing will disconnect from the fluid connector hub without removing the catheter from the user's skin, thus saving the patient from the need to obtain, re-insert, and connect a new infusion set.
SUMMARY OF THE INVENTION
An object of embodiments of the present invention is to substantially address the above and other concerns, and to provide improved infusion devices. Another object of embodiments of the present invention is to provide an improved needle shield device configured to conceal and/or protect an introducer needle after insertion of a catheter.
These and other objects are substantially achieved by providing an introducer needle assembly including a needle and a needle shield device. The needle has a sharpened end and an opposing end, and is insertable through a base. The needle shield device includes an inner shield connectable to at least one of the base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end of the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.
These and other objects are also substantially achieved by providing a needle assembly including a needle and a needle shield device. The needle has a sharpened end and an opposing end, and is insertable through a base. The needle shield device includes an inner shield connectable to at least one of the base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end of the needle. Interaction between portions of the inner and outer shields during or after the outer shield is proximally displaced relative to the inner shield by a predetermined distance causes automatic release or permits release of the inner shield from connection to the at least one of the base and the fluid connector.
These and other objects are also substantially achieved by providing a method, including providing a needle assembly that includes a needle and a needle shield device. The needle has a sharpened end and an opposing end, the needle being insertable through a base. The needle shield device includes an inner shield connectable to at least one of the base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end of the needle. The method also includes displacing the outer shield by a predetermined distance relative to the inner shield, and, by interaction between portions of the inner and outer shields during or after the outer shield is proximally displaced, releasing the inner shield from connection to the at least one of the base and the fluid connector.
These and other objects are also substantially achieved by providing a needle assembly that includes a needle and a needle shield device. The needle has a sharpened end and an opposing end, and is insertable through a base. The needle shield device includes a first shield, a second shield, and a biasing element. The first shield is connectable to one of the base and a fluid connector connectable to the base, the first shield being fixedly connected to the opposing end of the needle and having at least one cantilevered arm with a tapered edge. The second shield has a stop. In a first position of the second shield relative to the first shield, in which the sharpened end of the needle is exposed outside the second shield, the stop engages with the tapered edge of the first shield to create a jam connection with the one of the base and the fluid connector.
The first and second shields having a common central axis. The biasing element biases the first shield axially away from the second shield. Proximal displacement of the second shield relative to the one of the base and the fluid connector proximally displaces the first shield along with the second shield until the first shield is no longer connected to the one of the base and the fluid connector. When the first shield is no longer connected to the one of the base and the fluid connector, under the force of the spring, the cantilevered arm of the first shield deflects relative to the stop and the first shield displaces axially relative to the second shield to cover the sharpened end of the needle.
These and other objects are also substantially achieved by providing a needle assembly that includes a and a needle shield device. The needle has a sharpened end and an opposing end, and is insertable through a base. The needle shield device includes a needle hub and a shield. The needle hub is fixedly connected to the opposing end of the needle. The needle hub has a hub base disposed at a proximal end thereof shrouding a portion of the needle. The shield has an inner cavity and is hingedly connected to the needle hub. The shield is also rotatable relative to the needle hub between a first position in which the sharpened end of the needle is exposed outside the needle shield device, and a second position, in which the sharpened end of the needle is covered within the cavity. Upon rotating to the second position, the shield engages and latches with the hub base.
These and other objects are also substantially achieved by providing a needle assembly that includes a needle and a needle shield device. The needle has a sharpened end and an opposing end, and is insertable through a base. The needle shield device includes first and second shields. The second shield is displaceable relative to the first shield between a first position, in which the sharpened end of the needle is exposed outside the first and second shields, and a second position, in which the sharpened end of the needle is shielded by the first and second shields. One of the first and second shields is connectable to at least one of the base and a fluid connector connectable to the base. One of the first and second shields is fixedly connected to the opposing end of the needle. Interaction between portions of the inner and outer shields during or after proximal displacement of the second shield from the first position to the second position automatically releases or permits release of the one of the first and second shields from connection to the at least one of the base and the fluid connector.
These and other objects are also substantially achieved by providing an infusion set, including a base and a locking fluid connector. The base includes a base portion, a septum, and a cannula. The base portion has a column extending proximally therefrom. The column includes a plurality of inverted J-shaped engagement structures with cantilevered ends. The engagement structures form engagement pockets therein and are circumferentially arrayed around the column and separated by a plurality of slots. The septum is disposed within the column. The cannula protrudes distally from the base portion and is in fluid communication with a distal side of the septum.
The locking fluid connector includes a tubing portion having a tubing port for connecting tubing thereto, and a hub portion for connecting with the base. The hub portion includes a domed portion and a blunt cannula for penetrating the septum. The blunt cannula extends from the domed portion and is fluidly connected with the tubing port. The hub portion also includes a plurality of engagement fingers protruding radially inward, and a spring element held within the domed portion by the engagement fingers. The engagement fingers are alignable with the aligning the slots. The locking fluid connector is displaceable toward the base when the blunt cannula is aligned with the septum and the engagement fingers are aligned with the slots, thereby compressing the spring element. The locking fluid connector is rotatable about the column once the engagement fingers have distally cleared the cantilevered ends of the engagement structures. The locking fluid connector is displaceable away from the base under the force of the spring element with the engagement fingers disposed within the engagement pockets to lock the fluid connector to the base in one of a plurality of discrete rotational orientations.
These and other objects are also substantially achieved by providing an infusion set, including a base and a fluid connector. The base includes a base portion, a septum, and a cannula. The base portion has a column extending proximally therefrom. The column includes a ball-shaped base latch at its proximal end. The septum is disposed within the column. The cannula protrudes distally from the base portion and is in fluid communication with a distal side of the septum.
The locking fluid connector includes a tubing portion having a tubing port for connecting tubing thereto, and a hub portion for connecting with the base. The hub portion includes a domed portion and a blunt cannula for penetrating the septum. The blunt cannula extends from the domed portion and is fluidly connected with the tubing port. The hub portion also includes a plurality of distally cantilevered snap latches, each having an internal angular profile to snap over the base latch to connect the fluid connector with the base.



BRIEF DESCRIPTION OF THE DRAWINGS
The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which:
FIG. 1 is a perspective view of a needle hub connected to an infusion set base in accordance with an exemplary embodiment of the present invention;
FIG. 2 is a cross-sectional view the needle hub and base of FIG. 1;
FIG. 3 is a perspective view of the base of FIG. 1;
FIG. 4 is a cross-sectional view of the base of FIG. 1;
FIG. 5 is a perspective view of a fluid connector attached to the base of FIG. 1 in accordance with an embodiment of the present invention;
FIG. 6 is a cross-sectional view of the fluid connector and base of FIG. 5;
FIG. 7 is an exploded view of the needle hub of FIG. 1;
FIG. 8 is an exploded view of the fluid connector and base of FIG. 5;
FIG. 9 is perspective view of the fluid connector of FIG. 5 and a reservoir connector;
FIG. 10 is another cross-sectional view of the fluid connector and the base of FIG. 5;
FIG. 11 is an exploded view of the fluid connector of FIG. 5;
FIG. 12 illustrates opposing perspective views and a cross-sectional view of a split septum in accordance with an exemplary embodiment of the present invention;
FIG. 13 is a perspective view of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIG. 14 is a cross-sectional view of the needle shield device of FIG. 13;
FIG. 15 is a perspective view of the needle shield device of FIG. 13 in a safe state;
FIG. 16 is a cross-sectional view of the needle shield device of FIG. 13 in the safe state;
FIGS. 17 and 18 are additional cross-sectional views of the needle shield device of FIG. 13;
FIGS. 19-24 are perspective and cross-sectional views of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIGS. 25 and 26 are perspective cross-sectional views of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIGS. 27-31 are additional perspective cross-sectional views illustrating the operation of the needle shield device of FIG. 25;
FIGS. 32-34 are perspective cross-sectional views of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIG. 35 is a perspective cross-sectional view of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIG. 36 is a perspective view of a bias spring of the needle shield device of FIG. 35;
FIG. 37 is a perspective view of a fluid connector used with the needle shield device of FIG. 35;
FIGS. 38-40 are perspective cross-sectional views illustrating the operation of the needle shield device of FIG. 35;
FIG. 41 is a perspective view of an alternative bias spring;
FIG. 42 is a perspective cross-sectional view of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIG. 43 is a perspective cross-sectional view of the needle shield device of FIG. 42, taken along line 43-43 of FIG. 42;
FIG. 44 is partial, perspective cross-sectional view of the needle shield device of FIG. 42 illustrating spring slots;
FIGS. 45 and 46 are perspective cross-sectional views illustrating operation of the needle shield device of FIG. 42;
FIG. 47 is a perspective view of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIGS. 48 and 49 illustrate the needle shield device of FIG. 47 after deployment of a needle shield;
FIG. 50 is a cross-sectional view of the needle shield device of FIG. 47 prior to deployment of the needle shield;
FIGS. 51 and 52 are cross-sectional views of the needle shield device of FIG. 48 after deployment of the needle shield;
FIGS. 53 and 54 are perspective views of a needle shield device in accordance with an exemplary embodiment of the present invention;
FIG. 55 is a perspective cross-sectional view of and introducer needle, a fluid connector, and a base fully engaged with each other in accordance with an exemplary embodiment of the present invention;
FIG. 56 is a perspective cross-sectional view of the fluid connector of FIG. 55;
FIG. 57 is a bottom perspective view of the fluid connector of FIG. 55;
FIG. 58 is a perspective cross-sectional view of an alternative exemplary fluid connector of FIG. 55;
FIG. 59 is a connector disposed in the fluid connector hub of FIG. 58;
FIG. 60 is a bottom perspective view of the fluid connector of FIG. 58;
FIG. 61 is a perspective view of the base of FIG. 55;
FIG. 62 is a perspective view illustrating the fluid connector of FIG. 55 ready to engage the base of FIG. 61;
FIG. 63 is a perspective view of another exemplary fluid connector in accordance with an exemplary embodiment of the present invention;
FIG. 64 is a perspective view of the fluid connector of FIG. 63 engaged with a base in accordance with an exemplary embodiment of the present invention;
FIG. 65 is a cross-sectional view of the fluid connector and base of FIG. 64;
FIG. 66 is a top view of the base of FIG. 64;
FIG. 67 is a cross-sectional view of the fluid connector and base of FIG. 63;
FIG. 68 is a perspective cross-sectional view of a fluid connector in accordance with an exemplary embodiment of the present invention;
FIG. 69 is a bottom perspective view of the fluid connector of FIG. 68;
FIG. 70 is a perspective view of an exemplary base for engagement with the fluid connector of FIG. 68;
FIG. 71 is a perspective view of the fluid connector of FIG. 68 engaged with the base of FIG. 70;
FIG. 72 is a perspective cross-sectional view of another exemplary fluid connector with a shroud in accordance with an embodiment of the present invention;
FIGS. 73 and 74 are additional exemplary embodiments of the fluid connector of FIG. 72;
FIG. 75 is a sectional view of another exemplary fluid connector in accordance with an exemplary embodiment of the present invention;
FIGS. 76 and 83 are perspective views of a needle shield device in accordance with an exemplary embodiment of the present invention; and
FIGS. 77-82 are perspective cross-sectional views illustrating operation of the needle shield device of FIG. 76.



DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
As will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements and arrangements of infusion-associated devices disclosed herein. Although reference will be made to the exemplary embodiments depicted in the drawings and the following descriptions, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed invention. As will be understood by one skilled in the art, terms such as up, down, bottom, top, proximal, and distal are relative, and are employed to aid illustration, but are not limiting.
FIG. 1 illustrates an exemplary embodiment of an infusion set comprising an introducer needle hub 100 engaged with a base 102. The base 102 engages a flexible disc 104 positioned between the base 102 and a user. The flexible disc 104 provides improved comfort and mobility of the device because it moves with the user during physical activity while minimizing contact of the rigid portions of the base 102 with the user. The flexible disc 104 is attached to an adhesive patch or pad 106 having an adhesive backing, which is used to secure the base 102 to the user's skin. FIG. 1 illustrates a state in which the introducer needle hub 100 and base 102 are ready to facilitate insertion of a soft (flexible) catheter 108 and an introducer needle 110 into the user.
FIG. 2 is a cross-sectional view of the base 102 and introducer needle hub 100 configuration shown in FIG. 1. The introducer needle 110 is fixed to a needle mounting structure 112 within the introducer needle hub 100, thus fixing the introducer needle 110 against axial movement relative to the hub 100. The introducer needle hub 100 is used to insert the introducer needle 110 and the catheter 108 into the user without requiring the user to hold or manipulate the introducer needle 110 directly. The introducer needle 110 is preferably a hollow stainless steel needle with a sharp beveled distal end.
FIGS. 2-4 further illustrate features of the base 102. The base 102 includes a columnar post 113 surrounding an internal cavity 116. A mushroom-shaped base latch 114 is disposed at the proximal end of the post 113 The internal cavity 116 generally extends through the center of the base 102 providing a fluid passageway through the base 102. As shown, for example, in FIG. 2, the internal cavity 116 of the base 102 receives a retaining wedge 118 and a catheter 108. The wedge 118 has a funnel shape with a hollow center portion that narrows from a broad end to a narrow end 120. The narrow end 120 of the wedge 118 has a tapered end used to receive a terminal end of the catheter 108. The catheter 108 is forced over the narrow end 120 of the wedge 118 and the wedge/catheter assembly is inserted into the internal cavity 116 of the base 102.
Due to the flexible characteristics of the catheter 108, it may have a tendency to bunch up within the base 102 and therefore, the base 102 provides an additional cavity area 122 to accommodate excess catheter 108 material that may accumulate within the base 102 during the installation of the catheter onto the wedge 118. A pre-slit resilient septum 124 is also retained within the internal cavity 116 of the base 102. According to an exemplary embodiment, the septum 124 is held in place within the base 102 by a press fit, which provides a friction force between the septum 124 and both the base 102 and the wedge 118. Alternatively, the septum 124 may be fixed within the base 102 by an adhesive or by swaging plastic material from the base 102 over the top of the septum.
FIGS. 3 and 4 also illustrate first and second molded shots used in manufacturing base 102. The second molded shot (disc 104) may be of the same material as the first shot or may be of a different, more flexible material, which may include a silicone or thermoplastic elastomer, and thus, may be the flexible disc 104. As shown in FIG. 3, cutouts or holes 103 in the base 102 become filled with the material for the flexible disc 104, and thus, facilitate bonding between the base 102 and the flexible disc 104.
FIGS. 5 and 6 illustrate a fluid connector hub or fluid connector 126 connected to the base 102, and FIG. 7 illustrates an exploded view of the introducer needle hub 100 and base 102. The fluid connector hub 126 includes activation levers 128, fluid connector latches 130, and a rigid stop 132 (best shown in FIG. 11). The user attaches the fluid connector 126 to the base 102 by pressing the fluid connector axially down onto the base 102 and snapping it in place. In this process, the latches 130 and activation levers 128 resiliently deflect to allow the latches to pass over the mushroom-shaped base latch 114. Subsequently, the latches 130 and activation levers 128 return substantially to their undeformed or less deformed positions with the latches resiliently engaging the underside of the mushroom-shaped base latch 114 to prevent axial displacement of the fluid connector 126 relative to the base 102. In other words, during connection, the fluid connector latches 130 slide over the mushroom-shaped base latch 114 and resiliently return to a position where they snap and engage the base 102 via engagement with the post 113 and the base latch 114.
The user removes the fluid connector 126 by pressing the activation levers 128 together until they engage the rigid stop 132, thereby disengaging the latches 130 from the mushroom-shaped base latch 114. The user then lifts the fluid connector 126 axially away from the base 102.
In this exemplary embodiment, the activation levers 128 and the fluid connector latches 130 are molded from a resilient plastic material as a separate component from the fluid connector 126. The activation levers 128 and fluid connector latches 130 pivot on a living hinge. This may simplify manufacturing and reduce mold complexity. The rigid stop 132 ensures that both of the fluid connector latches 130 travel far enough to completely disengage from the mushroom-shaped base latch 114. The rigid stop 132 also provides a stable anchor for the activation levers 128 during the handling of the fluid connector 126. Additionally, according to one embodiment, the fluid connector 126 can freely rotate 360 degrees about the base 102, which provides the user with the ability to position the extension tubing 134, which connects the fluid connector 126 to an infusion pump.
FIGS. 8 and 9 illustrate an exploded and perspective view, respectively, of the components of an exemplary embodiment of an infusion set. The infusion set includes the fluid connector 126 and the base 102 as described above, and also includes the extension tubing 134 connecting the fluid connector 126 to a reservoir connector 136 that connects to an infusion pump, as well as a base adhesive 105 for connecting the adhesive patch 106 to the base 102 and/or the flexible disc 104, and an adhesive backing 107 for selectively protecting the distal adhesive surface of the adhesive patch 106.
FIG. 10 is a sectional view depicting a connected fluid path provided by the fluid connector 126 and the base 102. In this embodiment, the extension tubing 134 is connected to a tubing port 138 on the fluid connector 126. According to one embodiment, the tubing port 138 provides a press fit connection for the extension tubing 134, facilitating fluid flow from the infusion pump, through the extension tubing 134 and into the fluid connector 126. According to another embodiment, glue, or another bonding mechanism, such as solvent bonding, is used to secure the extension tubing 134 to the tubing port 138. The fluid path continues from the tubing port 138 into a molded cannula 140.
The molded cannula 140 extends in a direction substantially perpendicular to the longitudinal direction of the tubing port 138. In this embodiment, the molded cannula 140 is a rigid, substantially tubular member made of plastic and having either a tapered or rounded terminal end. The terminal end of the molded cannula 140 is used to penetrate through a pre-formed slit in the septum 124, thus providing a sealed fluid connection between the extension tubing 134 and the catheter 108. Fluid flows through the molded cannula 140, through the septum 124, then through the wedge 118 and into the catheter 108. The septum 124 provides a self-sealing feature, preventing fluid from exiting or leaking out of the base 102, except through the catheter 108. According to one embodiment, the molded cannula 140 is formed as an integral part of the fluid connector 126.
FIG. 11 is an exploded, perspective, cross-sectional view of the fluid connector 126. In this exemplary embodiment, the fluid connector 126 is formed using two distinct components: a first component 153, including the fluid connector latches 130 and the corresponding activation levers 128, and a second component 155, including the fluid connector shroud 142 (the top half of each component being omitted for clarity). The activation levers 128 have finger bumps 144 to aid the user in locating and using the activation levers 128. Alternatively, the finger bumps 144 may be replaced with a ridge or divots that can provide tactile feedback to the user regarding where to press to release the fluid connector 126 from the base 102. According to one embodiment, the activation levers 128 can have a different color than the fluid connector 126 to provide a visual indicator for the same purpose. The fluid connector shroud 142 of the fluid connector 126 has a smooth rounded exterior surface that aids in minimizing snagging or catching the fluid connector 126 on clothing or other objects during use. At the base of the fluid connector 126 there is a circular anchoring ring 146. The anchoring ring 146 forms a foundation and provides added stability around the base 102 when the fluid connector 126 engages with the base 102.
FIG. 11 also illustrates how the fluid connector shroud 142 and the fluid connector latches 130 are assembled. A male T-slot 148 feature on the first component 153 engages with a female T-slot 150 feature on the second component 155. Detents 152 and 154 on the first and second components 153 and 155 provide a mechanical lock between the two components. Alternatively, the fluid connector latches 130 and the fluid connector shroud 142 can be formed as a single integral molded plastic piece.
FIG. 12 illustrates the self-sealing resilient septum 124, which has a pre-pierced center 156 (shown partially opened for illustrative purposes) to receive the blunt molded cannula 140 from the fluid connector 126 and facilitate penetration of the septum 124. According to one embodiment, the septum 124 I sunder inward radial compression to ensure a seal at all times, with or without the molded cannula 140 being present. The septum 124 can be made of a soft resilient material including, but not limited to silicones, isoprene rubbers, or bromobutyl rubbers. The septum 124 can be made from a combination of these materials as well. The septum 124 ensures a complete seal during infusion and when the fluid connector 126 is disconnected from the base 102. The slit geometry of the septum 124 may be a single straight slit or multiple, intersecting straight slits. The slit may also be curved to ensure a complete seal during infusion and while the connector hub 126 is disconnected from the base 102.
FIG. 13 illustrates a needle shield device 158 with a tab 160 connected to the base 102, ready for placement on the skin, and FIG. 14 is a cross-sectional view of the needle shield device 158 fully engaged with the base 102, piercing the septum 124 and catheter with the introducer needle 110. The needle shield device 158 includes an outer shield 162 and an inner shield 164 that is connected to the tab 160. The outer and inner shields 162, 164 are both preferably made of a molded plastic material that is substantially rigid but that has some degree of flexibility.
FIGS. 15-18 illustrate the sequence of steps that occur to deploy the needle shield device 158 after the user has inserted the catheter 108 and removed the introducer needle 110 from the user's skin. For clarity, the base 102 is omitted from these figures. Briefly, the user holds the tab 160 on the base 102 while pulling up the outer shield 162, thereby extending the inner shield 164 disposed within the outer shield 162 to substantially conceal the introducer needle 110. As illustrated in FIG. 15, the inner shield 164 axially extends from the outer shield 162 to conceal the introducer needle 110.
FIG. 16 illustrates that the inner shield 164 includes a flexible shield beam or arm 166 and the outer shield includes a shield latch 168. In the completely extended position of the inner shield 164, the shield beam 166 engages the shield latch 168 to prevent the inner shield 164 from moving in the axial direction of the introducer needle 110. The engagement of the shield latch 168 with the shield beam 166 provides the user with a safe needle holder which prevents the possibility of an accidental needle stick.
As shown in FIGS. 16 and 17, the inner shield 164 has an opening 170 that the introducer needle 110 extends through. The needle shield device 158 includes a shield well 172 in the inner shield 164 that surrounds the exposed introducer needle 110 such that an average finger 173 will not fit through the shield well 172 opening and contact the concealed introducer needle 110. The inner shield 164 also includes a detent 174 on an internal surface thereof that prevents the inner shield 164 from collapsing once it is fully extended with respect to the outer shield 162. More specifically, once the internal structure 175 (to which the insertion needle is fixed) passes the detent 174 during withdrawal of the needle, the detent 174 engages the structure 175 to prevent axial displacement of the outer shield 162 relative to the inner shield 164. Thus, the detent 174 acts as a secondary mechanism to the shield beam 166 and shield latch 168.
FIGS. 19-24 illustrate another exemplary embodiment of a needle shield device 176. The needle shield device 176 includes an outer shield 162 and an inner shield 164 similar to the example described in connection with FIGS. 13-18. The inner shield 164 includes cantilevered retention beams 178, which have notches 180 for engaging the extension tubing 134 therebetween when the inner shield 164 is retracted within the outer shield 162.
FIG. 20 illustrates a cross-sectional view of the needle shield device 176 with the inner shield 164 extended with respect to the outer shield 162. The inner shield 164 includes a flexible shield beam or cantilevered arm or inner shield latch beam 166 formed with, for example, a tapered edge or inner shield latch 167. The outer shield 162 includes a shield latch or outer shield latch 168 for engaging with the shield beam 166. That is, in the completely extended position of the outer shield 162 with respect to the inner shield 164, the shield beam 166 engages the shield latch 168 to prevent the inner shield 164 from moving in the axial direction of the introducer needle 110.
FIGS. 21 and 22 illustrate that the inner shield 164 has an opening 170 that the introducer needle 110 extends through. The needle shield 176 forms a shield well 172 surrounding and concealing introducer needle 110 such that an average finger will not fit through the shield well 172 opening and contact the concealed introducer needle 110. Like the needle shield device 158, the inner shield 164 of the needle shield device 176 includes a detent 174 that prevents the inner shield 162 from collapsing once it is fully extended with respect to the outer shield 162 (that is, a secondary shield mechanism).
FIG. 23 illustrates an example of the outer shield 162 with one or more cams 182. As the outer shield 162 is extended with respect to the inner shield 164, the outer shield cams 182 travel along the retention beams 178 to keep the retention beams 178 biased and in a substantially fixed position. Further, referring back to FIG. 21, the cam or hub latch 182 prevents the separation of the inner shield 164 from the outer shield 162 during extension of the inner shield 164 relative to the outer shield 162.
FIG. 24. illustrates an example of the inner shield 164 with the retention beams 178 having outer edges 184 that are contracted by the cams 182. The base of the retention beams 178 include a tapered base or shield latch 186 to connect the retention beams 178 to the rest of the inner shield 164 and allow the retention beams 178 to bend more freely when not biased. As described above, the retention beams 178 have notches 180 for engaging the infusion tubing hub while the inner shield 164 is retracted within the outer shield and while the outer shield is displaced relative to the inner shield 164. The outer edges 184 of the retention beams 178 are in contact with the cam 182 during displacement of the outer shield 162 relative to the inner shield 164, thereby keeping the retention beams 178 in a substantially fixed position (i.e. secured to the extension tubing 134) until the inner shield 164 is fully extended with respect to the outer shield 162.
When the inner shield 164 is fully extended with respect to the outer shield 162, the cams 182 reach the tapered bases 186. At this point (at the tapered bases 186), the width of the outer edges 184 of the retention beams 178 is less than distance between of the cam 182, and thus, the cams 182 no longer bias or contact the outer edges 184 of the retention beams or cantilevered latch beams 178. This allows the retention beams 178 to bend more freely due to the tapered base 186 and release the extension tubing disposed in the notches 180 when the user continues to pull the needle shield device 176 axially upward, away from the base 102. That is, the contact between the outer edges 184 of the retention beams 178 and the cams 182 keep the extension tubing fixed to the needle shield device 176 until the inner shield 164 has been fully extended with respect to the outer shield 162. In the described example, the needle shield device 176 also provides the user with a mechanism to protect from an accidental needle stick and release the infusion set tubing hub in a single motion.
FIGS. 25-31 illustrate another exemplary embodiment of a needle shield device 188. FIG. 25 is a cross-sectional view of the needle shield device 188 that includes an outer shield 189 and a pre-biased inner shield 190. As shown in FIG. 26, the pre-biased inner shield 190 has a chamber 192 for holding a biasing element in the form of a compressed coil spring 194 (or any other suitable biasing element). FIG. 26 also illustrates that at the distal end of the chamber 192, the outer shield 189 includes a groove 196 for engaging the distal end of the spring 194.
The outer shield 189 includes a stop 198 that engages with a tapered edge 200 of the inner shield 190 to create a jam 202 with the fluid connector 126, thereby selectively maintaining the inner shield 190 in a substantially fixed position relative to the outer shield 189 despite the bias of the spring 194. That is, the potential energy stored in the pre-compressed spring 194 is less than the static friction formed between the stop 198, the tapered edge 200, and the jam 202 to keep the inner shield 190 in a substantially fixed position after assembly of the needle shield device 188.
Unlike the previously-described embodiments, in this embodiment, the fluid connector 126 is connected to the base 102 while the introducer needle 110 is installed in the catheter 108, that is, while the assembly is ready for insertion into a patient's skin. Thus, the fluid connector also has a pierceable septum 203 to maintain the integrity and sterility of the fluid path once the introducer needle 110 is removed. The introducer needle 110 is omitted from FIGS. 26-28 and 31 for clarity.
FIGS. 27-30 are exploded views of the needle shield device 188 that illustrate the removal of the introducer needle 110 from the user. FIG. 27 illustrates the needle shield device 188 being pulled away from the base 102 to begin removal of the introducer needle 110. The additional force applied by the user to the outer shield 189 and the potential energy stored in the spring 194 exceed the static friction formed by the stop 198, the tapered edge 200, and the jam 202, thereby causing the needle shield device 188 to displace axially and disengage from the fluid connector 126 and disengage the jam 202 under the force of the user and the spring 194. FIG. 28 illustrates the state during removal in which the inner shield 190 is no longer in contact with the fluid connector 126, thereby fully disengaging the jam 202. In one embodiment, the potential energy stored in the spring 194 exceeds the force required to move the stop 198 past the tapered edge 200 when the jam 202 is removed, as illustrated in FIG. 29, thereby causing the inner shield 190 to displace in the axial direction of the introducer needle 110 after disengaging the jam 202.
FIG. 30 illustrates the state in which the inner shield 190 has fully displaced and an edge or catch 204 of the outer shield 162 engages with an edge or catch 206 of the inner shield 190. In such an exemplary embodiment, the spring 194 may remain biased to keep the edges 204 and 206 engaged. FIG. 30 also illustrates that the introducer needle 110 extends through an opening 170 into the shield well 172 of the inner shield 190. The well 172 surrounds the concealed introducer needle 110 so that an average finger 173 will not fit through the opening of the shield well 172 and contact the concealed introducer needle 110. In this embodiment, the needle shield device 188 automatically releases the inner shield 190 during withdrawal of the introducer needle 110 in a single motion, and provides the user with a mechanism to protect from an accidental needle stick.
FIG. 31 illustrates an alternative embodiment of the needle shield device 188 in which the outer shield 189 includes cantilevered, tapered edge beams 208 that are circumferentially interposed between the edges 204. The edge beams 208 are biased radially by snap latches 210 of the inner shield 190 when the introducer needle 110 is in an exposed position. As the spring 194 displaces the inner shield 190 upward, the snap latches 210 move past the distal ends of the tapered edge beams 208, and the edge beams 208 move radially inward and latch and an edges 212 of the tapered edge beams 210 latch with the snap latches 210, thereby preventing movement of the inner shield 190 in the axial direction of the introducer needle 110. In other words, once fully-extended, the interaction between the edges 204 and 206 prevent the inner shield 190 from moving upward and the interaction between the edge beams 208 and the snap latches 210 prevent the inner shield from moving downward, thus locking the introducer needle in a covered position, and preventing exposure of the introducer needle 110.
The embodiment of FIGS. 32-34 is similar to the embodiment of FIGS. 25-31, but differs in several respects. For example, rather than connecting to the fluid connector, the needle shield device 50 connects directly to the base 102. Additionally, rather than a pre-compressed spring pushing the inner shield upward relative to the outer shield, the pre-compressed spring 52 pushes the inner shield 54 downward relative to the outer shield 56 after the needle shield device disengages from the base 102. In more detail, the outer shield 56 has an inner portion 58 (to which the introducer needle 110 is connected) that includes a stop 60 at a distal end thereof. When the needle shield device 50 is connected with the base 102, the introducer needle 110 is in an extended position disposed in the catheter 108. In this position, the stop 60 engages a tapered edge 62 of a rim 64 of the inner shield 54 to create a jam 66 with the base 102, thereby selectively maintaining the inner shield 54 in a substantially fixed position relative to the outer shield 56 despite the bias of the spring 52. That is, the potential energy stored in the pre-biased spring 52 is less than the static friction formed between the stop 60, the tapered edge 62, and the jam 66 to keep the inner shield 54 in a substantially fixed position after assembly of the needle shield device 50.
As the needle shield device 50 is pulled away from the base 102 and the jam 66 is disengaged, the force of the spring 52 drives the inner shield 54 downward relative to the outer shield 56. As shown in FIG. 33, which illustrates a state just prior to the inner shield 54 being fully extended and locked out, the jam 66 slides along an internal surface of the inner shield. Once fully extended, as shown in FIG. 34, an edge or catch 68 of the outer shield 56 engages an edge or catch 70 of the inner shield 54 to prevent the inner shield 54 from displacing further distally relative to the outer shield 56. Additionally, the jam 66 engages a proximal surface of the inner shield 54 to prevent the inner shield 54 from displacing proximally relative to the outer shield 56. Thus, the introducer needle 110 is shielded from an average finger 173.
Relative to the embodiment of FIGS. 25-31, the embodiment of 32-34 is simpler to mold, and does not require radial orientation during assembly.
FIG. 35 is a cross-sectional view of another embodiment of a needle shield device 214 fully engaged with the base 102, piercing the septum 124 and catheter with the introducer needle 110 and ready for placement on the skin. The needle shield device 214 includes a spring element or metal spring clip 216 to protect or shield the tip of the introducer needle 110 after withdrawal from the user's skin. FIG. 36 is a perspective view of the spring clip 216 which has a retention hole 218 for retaining the introducer needle 110 and a large hole 220 for passing a bump on the introducer needle 110 (best shown in FIGS. 39 and 40). The spring clip 216 also includes latch tabs 222 and a trigger 224 for protecting the tip of the introducer needle 110. FIG. 37 is a perspective view of the fluid connector 126 that includes hub latches 226 for engaging the latch tabs 222 and maintaining the spring clip 216 in a substantially fixed position prior to withdrawal of the introducer needle 110 from the base 102.
FIGS. 38-40 are cross-sectional views that illustrate the operation of the needle shield device 214 using the spring clip 216. Initially, as shown in FIG. 38, the spring clip 216 is biased by the introducer needle 110 via the trigger 224 so that the latch tabs 222 are retained by the hub latches 226 disposed on the fluid connector 126, thereby substantially retaining the spring clip 216 in the initial position.
As the introducer needle 110 is withdrawn from the fluid connector 126 and the base 102 along with the needle hub or handle 215, as shown in FIG. 40, the introducer needle 110 rides along the trigger 224. In the embodiment of FIG. 39, the introducer needle 110 includes a bump 228 disposed near its distal tip. As the bump 228 passes the trigger 224, the spring clip 216 experiences additional bias due to the bump 228.
FIG. 40 illustrates the state in which the spring clip becomes unbiased as the introducer needle's tip is retracted past the trigger 224. In response to the unbiasing of the spring clip 216, the latch tabs 222, which were prevented from displacing axially by the hub latches, displace forward, thereby unlatching from the hub latches 226 and releasing the spring clip 216 from connection with the hub latches 226 of the fluid connector 126. FIG. 40 further illustrates that, as the introducer needle 110 is retracted, the bump 228 passes through the large hole 220 but does not pass through the retainer hole 218 of the spring clip 216. Further, after becoming unbiased, the spring clip 216 is positioned such that the trigger 224 covers the tip of the introducer needle 110. In this embodiment, the needle shield device 214 automatically releases the spring clip 216 during withdrawal of the introducer needle 110 in a single motion and provides the user with a mechanism to protect from an accidental needle stick.
FIG. 41 illustrates an alternative embodiment of the spring clip 216 having a transverse portion 230. The transverse portion 230 reduces the elasticity of the spring clip 216, thereby increasing the bias strength of the spring clip 216.
FIG. 42 is a cross-sectional view of another embodiment of a needle shield device 232 fully engaged with the fluid connector 126 and the base 102, piercing the septum 124 and catheter with the introducer needle 110 and ready for placement on the skin. FIG. 43 is another cross-sectional view of the needle shield device 232 taken at 90 degrees with respect to FIG. 42. The needle shield device 232 includes a cavity 234 over the fluid connector 126 for housing a spring element or biased spring 236. In the example of FIGS. 42 and 43, the spring 236 is biased in contact with the fluid connector 126 and a surface 238 at the proximal end of the cavity 234.
FIG. 44 is a cross-sectional view of the spring 232 showing that it includes slotted holes 240 for the introducer needle 110 to pass through. The slotted holes 240 are axially aligned with the septum 124. The spring 236 also includes a small hole 242 and a tip pocket 244 at the distal end of the spring 236, which is in contact with the fluid connector 126.
FIGS. 45 and 46 illustrate the removal of the needle shield device 232. In FIG. 45, when the needle shield device 232 is retracted to withdraw the introducer needle 110 from the fluid connector 126 and the base 102, the biased spring 236 unbiases and expands along the axis of the introducer needle 110. According to one embodiment, the slotted holes 240 are longitudinal slots aligned to accommodate the introducer needle 110 as the spring 236 expands.
FIG. 46 illustrates that the needle shield device 232 is fully retracted and the spring 236 extends over the tip of the introducer needle 110, so that the tip is disposed in the tip pocket 244. Further, according to one embodiment, the small hole 242 is biased to one side of the spring 236 so that when the tip of the introducer needle 110 passes through the hole 242, the spring 244 transversely unbiases so that the hole 242 is not axially aligned with the introducer needle 110. That is, a barrier is formed over the tip of the introducer needle 110 when the spring 236 unbiases and substantially covers the introducer needle 110.
According to one embodiment, the spring 236 can be a compression spring (for example, a spiral or coil spring) or a tapered compression spring to provide the force necessary to shield the tip of the introducer needle 110. In such an embodiment, a tip shield can be disposed at the distal end of the spring to cover the tip of the introducer needle 110 after expansion of the spring.
The needle shield device 232 automatically releases the transverse barrier formed by the tip pocket 244 and hole 242 during retraction of the introducer needle 110 in a single motion and provides the user with a mechanism to protect the user from an accidental needle stick.
FIGS. 47-52 illustrate another exemplary embodiment of a needle shield device 246. FIG. 47 is a perspective view of the needle shield device 246 with a shield 248 that is disposed over the extension tubing 134 prior to insertion. The shield 248 includes a hinge 249 that may be formed by molding the needle shield device 246 as a single piece. In an alternative exemplary embodiment, the hinge 249 may be molded separately and fixed to the needle shield device 246. The shield 248 generally has a U-shaped profile and is deployed after removal from the fluid connector 126 and/or base 102 by rotating the shield 248 about the hinge 249. FIGS. 48 and 49 illustrate the shield 248 after deployment. The shield 248 includes latches 250 on an inner surface to keep the shield 248 in a substantially fixed position after deployment.
FIG. 50 is a cross-sectional view of the needle shield device 246 and illustrates that the shield 248 has an inner cavity 252 that is press fit and latches with a base 254 of the needle shield device 246. According to one embodiment, the shield 248 latches to the base 254 without contacting or bending the needle 110. FIG. 51 is a cross-sectional view of the needle shield device 246 after deployment, and illustrates that the distal end of the shield 248 extends beyond the tip of the introducer needle 110. FIG. 52 is another cross-sectional view at 90 degrees with respect to FIG. 51 and illustrates that a gap 256 of the shield 248 is smaller than the average finger, to prevent an accidental needle stick.
Conventional one-piece protective shields generally have more than a 90-degree rotation and may require the user to bend or break the needle. This requires extra force and/or extra manufacturing (e.g., a notch in the introducer needle to facilitate bending or breaking). Such conventional designs also result in a wider needle holder that is physically larger and more difficult to dispose of. The above-described exemplary embodiment is easier to manufacture by reducing manufacturing steps and also is easier to operate because the integrity of the introducer needle is maintained. Further, the above-described exemplary embodiment is physically smaller than conventional shields and is therefore easier to dispose of.
FIGS. 53 and 54 are perspective views of another embodiment of a needle shield device 74. The introducer needle 110 is omitted from FIG. 53 for clarity. The needle shield device 74 includes a needle hub 76 and a shield 78 rotatably connected to the needle hub 76 by a hinge 82, such as a living hinge. The shield 78 includes one or more cantilevered needle-engaging flaps 80. When the user rotates the shield 78 to enclose the introducer needle 110, as shown in FIG. 54, the flaps 80 are disposed to permit the flaps 80 to pass the introducer needle 110 in one direction, but prevent the shield from passing the introducer needle in the opposite direction thereafter. In other words, once the shield 78 is deployed to cover the shield, the flaps engage the introducer needle 110 to prevent the shield 78 from returning to its initial position.
FIGS. 55-59 depict a locking fluid connector 258 that a user may place in, for example, six different rotational positions. FIG. 55 is a cross-sectional view of the locking fluid connector 258 and includes a base 260 that the locking fluid connector 258 locks onto. The fluid connector 258 includes a tubing portion 259 with a tubing port for connecting tubing thereto, and a hub portion 261 for connection with the base 260. The hub portion 261 has a domed portion 263. FIG. 56 is a cross-sectional view of the locking fluid connector 258 and includes engagement fingers 262 protruding radially inward at the distal opening of the domed portion. The molded cannula 140 extends from the domed portion and is in fluid communication with the tubing port. The engagement fingers 262 fix a tensile element such as, for example, a spring 264 within the locking fluid connector 258. The spring 264 in FIG. 56 may be biased or, alternatively, may be unbiased when the locking fluid connector 258 is not connected to the base 260. FIG. 57 is a bottom perspective view of the locking fluid connector 258 that illustrates that the spring 264 and the fingers are separate.
FIGS. 58-60 illustrate an alternative exemplary embodiment of the locking fluid connector 258. FIG. 58 is a cross-sectional view of the locking fluid connector 258 and illustrates that a connector 266 is disposed in the locking fluid connector 258. FIG. 59 illustrates that the connector 266 has fingers 268 and a leaf spring 270 integral therewith, in other words. In other words, in the embodiment of FIG. 59, the fingers and spring are integrally formed as one body. FIG. 60 is a bottom view of the locking fluid connector 258 with the connector 266 placed therein and illustrates that the leaf springs 270 are not biased when the locking fluid connector 258 is not connected to the base 260.
FIG. 61 depicts the base 260 in more detail. The base 260 has a column that includes inverted J-shaped engagement structures or protrusions 273 having cantilevered ends and tapered edges that protrude in the radial direction from the column. The protrusions 273 include a notch to form engagement pockets 272 and are separated by slots 274. In the exemplary embodiment, the engagement pockets 272 and the slots 274 are configured to receive the engagement fingers of the locking fluid hub retention set 258 and lock it into a predetermined number of discrete rotational orientations (e.g., 6, 8, etc.).
FIG. 62 illustrates that, in the event that the engagement fingers 262 of the locking fluid connector 258 are aligned and placed into the slots 274, the spring 264 is in contact with a tapered top surface 276 of the base 260. A user then applies a force to bias the spring 264, causing the engagement fingers 262 to travel into the slots 274. The user then rotates locking fluid connector 258 and releases it, thereby allowing the spring 264 to partially unbias and move the engagement fingers 262 to move into contact with the base 260 via the engagement pockets 272. In this configuration, the locking fluid connector 258 is locked into base 260 via the engagement pockets 272 and can only be removed by pressing on the locking fluid connector 258, rotating it to align the engagement fingers 262 with the slots 274, and releasing the locking fluid connector 258.
The exemplary embodiment provides a locking retention fluid set 268 that can be easily removed and provides a fixed number of rotational positions to allow the user to select the best position of the extension tubing 134. The base 260 may also be made of a rigid or flexible material via a die-cut process, molding process, or a two-step molding process. Various shapes of shrouds may also be used to contour and minimize the potential to snag on objects (e.g., clothing, furniture, etc.) and optimized for ease of handling and intuitive use.
FIG. 63 illustrates another exemplary embodiment of a locking fluid connector 278 having levers 280 with a latch 282 integral thereto. FIG. 64 illustrates the locking fluid connector 278 fully engaged with the base 102, and ready for placement on the skin. The locking fluid connector 278 is locked into a substantially fixed position via a predetermined number of catches 284 disposed on the surface of the base 102. FIG. 65 illustrates a cross-sectional view of the locking fluid connector 278 and depicts one example of a latch 282 engaged with a catch 284.
FIG. 66 illustrates a base 102 having six different catches 284 to allow a user to place the locking fluid connector 278 in six different rotational positions. To remove the locking fluid connector 278, the user squeezes the levers 280 together to cause the latches 282 to disengage from the catches 284. The user then rotates the locking fluid connector 278 such that the latches 282 are not aligned with the catches 284 and releases the levers 280 and lifts off the locking fluid connector 278. In an alternative embodiment, the levers 280 can displace sufficiently to disengage the latches 282 from the catches 284 to permit the user to simply lift the fluid connector 278 from the base 102 without rotation.
The levers 280 are sufficiently displaceable that, if correctly aligned, the fluid connector 278 can be axially lowered onto the base 102 and the latches 282 can snap into engagement with the catches. As shown in FIG. 67 the blunt cannula 140 must be axially aligned with the septum 124 so that the latches 282 can be placed into the catch 284 to place the locking fluid connector 278 into a fixed position.
In an alternative embodiment, to lock the locking fluid connector 278, the user places the latches 282 such that they are not aligned with the catches 284, and then rotates the locking fluid connector 278 until at least one of the latches 282 engage with at least one of the catches 284
The squeeze action of the locking fluid connector 278 is more user friendly and intuitive compared to depressing a single button. Further, the release mechanism is more reliable because it requires fewer assembly tolerances.
FIG. 68 is a cross-sectional view of exemplary embodiment of a fluid connector 286 fully engaged with the base 102, piercing the septum 124 and catheter 108 with the introducer needle 110 and ready for placement on the skin. FIG. 69 depicts the bottom of the fluid connector 286 and FIG. 70 illustrates a base latch 288 that the fluid connector 286 connects to. The fluid connector 286 includes at least one snap latch 290 having an angular profile to snap over the base latch 288. For example, FIG. 70 illustrates a spherically shaped post or ball 289 on the base latch 288 to receive the snap latches 290. The snap latches 290 are configured to unlatch from the ball 289 in the event that the fluid connector 286 experiences undesired force that would normally remove the catheter from the user. That is, the fluid connector 286 is designed to separate from the base 102 to prevent inadvertent removal of the catheter from the user's body in the event that, for example, the extension tubing 134 is accidentally pulled by an external object (e.g., a doorknob, furniture, etc.).
FIG. 71 illustrates the fluid connector 286 connected to the base latch 288 and is able to rotate 360 degrees around the base latch 288, which may be partially exposed between the snap latches 290. The fluid connector 286 includes a sheath 292 that receives the extension tubing 134 and has a sheath base 294 that extends along the sheath 292. The sheath base 294 protrudes from the bottom surface of the sheath 292 toward the base 102. In the embodiment of FIG. 71, the sheath 292 and the sheath base 294 generally do not extend beyond the radius of the base 102. The sheath base 294 provides support to prevent the fluid connector 286 from unlatching in the event an undesired force is asserted on the sheath 292 or extension tubing 134.
FIG. 72 is a cross-sectional view that illustrates another exemplary embodiment of the fluid connector 286 having a shroud 296 with a hemispherical dome shape that extends over and substantially encloses the snap fingers 290. In FIG. 72, the radius of the shroud 296 is less than the radius of the base 102. FIG. 73 illustrates an exemplary embodiment of a tapered shroud 298 that tapers the edges to be substantially planar with the surface of the base 102. The purpose of the shroud 296 is to prevent the user from squeezing the snap latches 290 during removal, which would make it difficult to remove the fluid connector 286 from the base 102. Also, the low profile of the shroud 296 minimizes the potential for unintentionally snagging the fluid connector 286 on clothing or objects.
FIG. 74 illustrates another exemplary embodiment of a tapered shroud 298 with tapered edges that are substantially planar with the surface of the base 102. The tapered shroud 298 impedes accidental disengagement of fluid connector 286 from the user. In another exemplary embodiment of the fluid connector 286 illustrated in FIG. 73, the radius of the tapered shroud 298 is substantially equal to the radius of the base 102. In other embodiments, the shape of the tapered shroud 298 may be modified in any suitable manner for aesthetic purposes or to enhance the user's grip on the fluid connector 286.
The exemplary embodiment provides a fluid connector that separates from the user's body prior to removal of the catheter in the event that the fluid connector experiences an undesired external force. Further, the above-described example provides a shroud with a tapered edge that is substantially planar with the user's skin to facilitate engagement and impede accidental disengagement of the fluid retention set. The exemplary embodiment also includes a sheath with a base to prevent inadvertent removal of the fluid connector from the base 102 due to an undesired force experienced by the extension tubing.
FIG. 75 illustrates another exemplary embodiment of a fluid connector 300 having a septum 302 disposed therein to allow priming of an introducer needle (not shown) disposed in the fluid connector 300 before insertion. The septum 302 is cylindrical in shape and is placed in the axial direction of the extension set tubing 134 such that a fluid path 304 is formed below the septum 302. In this exemplary embodiment, the introducer needle is configured to receive the fluid so that the fluid connector 300 may be primed prior to insertion of the introducer needle.
Alternatively, the septum 302 can be the tubing 134, so long as the tubing material possesses sufficient healing (sealing) properties to prevent leakage due to the slit caused by the introducer needle 110, while still having suitable material properties to perform the other functions required of the tubing 134.
FIG. 76 illustrates a passive needle shield device 400 connected to the base 102 and ready for placement on the skin. FIG. 77 is a cross-sectional view of the needle shield device 400 fully engaged with the base 102, piercing the septum 124 and the catheter 108 with the introducer needle 110. The needle shield device 400 includes a shield needle hub or outer shield 402 which surrounds and encloses an inner shield 404 and the introducer needle 110.
FIGS. 78-81 illustrate the sequence of steps that occur after the user has inserted the catheter 108. In other words, these figures illustrate the operation of removing the needle shield device 400 from the base 102. Briefly, the user simply pulls on the outer shield 402 in a direction away from the base 102 to remove the introducer needle 110. According to one embodiment, the outer shield 402 and inner shield 404 are both made of rigid plastic materials that have some degree of flexibility.
In more detail, FIG. 78 is a quarter-sectional view illustrating an initial state of the needle shield device 400 and a first position of the outer shield 402 relative to the inner shield 404, in which an outer shield hub latch 406 contacts the base 102 and also contacts a cantilevered latch beam 408 of the inner shield 400 to maintain engagement of the latch beam 408 with the base 102 beneath the base latch 114. According to one embodiment, the hub latch 406 biases the latch beam 408 radially inward.
FIG. 79 illustrates the orientation of the needle shield device 400 while the user is axially displacing the outer shield 402, but before it has completed its stroke relative to the inner shield 404. In this state, the outer shield 402 continues to prevent the latch beam 408 from disengaging from the base 102. More specifically it is the hub latch 406 that holds the latch beam 408 in place against the base 102. Therefore, according to one embodiment, the inner shield 404 is locked onto the base 102 while the outer shield 402 is being axially displaced relative to the inner shield 404.
FIG. 80 illustrates the completely displaced position of the outer shield 402 with respect to the inner shield 404. In this state, the hub latch 406 no longer prevents the latch beam 408 from disengaging from the base 102. The hub latch 406 is instead disposed in an indent 409 (best shown in FIG. 77) on the inner shield 404 and engaged with a shield latch 410 formed on the inner shield 404. The shield latch 410 engages a top side of the hub latch 406, thereby preventing further proximal displacement of the outer shield 402 relative to the inner shield 404. Additionally, because the hub latch 406 is no longer pressing on the latch beam 408, the latch beam 408 can disengage from the base 102.
Further, a hub beam or outer shield latch 412 rides over an inner shield latch 414 and the bottom of the hub beam 412 engages the top of the inner shield latch 414 to prevent distal displacement of the outer shield 402 relative to the inner shield 404. According to one embodiment, the hub beam 412 is cantilevered.
The latch beam 408 is free to radially displace and disengage from the base 102 once the user continues to distally displace the needle shield device 400. The engagement of the shield latch 410 with the hub latch 406 and the engagement of the hub beam 412 with the inner shield latch 414 shields the introducer needle 110 and thereby reduces the possibility of an accidental needle stick.
According to one embodiment, the inner shield latch 414 is fixedly disposed on the inner shield 404. According to another embodiment, the inner shield latch 414 is disposed on a cantilevered inner shield latch beam 416 so that both the inner shield latch beam 416 and the hub beam 412 are cantilevered. According to yet another embodiment, the inner shield latch 414 is disposed on a cantilevered inner shield latch beam 416 and the hub beam is fixedly disposed on the outer shield 402.
In another alternative embodiment, the needle shield device 400 can also be attached to a fluid connector 126 and the base 102. Such an embodiment allows a user to prime the infusion set while it is outside the body and insert and remove the introducer needle 110 with the fluid connector 126 attached the entire time.
FIG. 81 illustrates a completely deployed needle shield device 400. The latch beam 408 is removed from the base 102 as the user continues to pull on the outer shield 402. FIG. 82 is a perspective view illustrating the needle shield 400 in the completely deployed state, removed from the base 102 and ready for disposal.
FIG. 83 illustrates how the introducer needle 110 within the needle shield device 400 is prevented from contacting a user's finger 173 during handling of the completely deployed needle shield device 400. The inner shield 404 forms a shield well 414 surrounding the exposed introducer needle 110 such that an average finger 173 will not fit through the shield well 414 opening and contact the exposed introducer needle 110.
In each of the herein disclosed embodiments and in other alternative embodiments, the components of the infusion set can be made of injection-molded polypropylene, polyethylene, polyesters, acrylonitrile-butadiene-styrene polymers, and/or bio-based resins such as polylactide, starch-filled polypropylene, or polyhydroxyalkanoates. The catheter can be a separate component or injection-molded as part of the base assembly, either as a single part or as a coinjection-molded part using two resins.
Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.

## Claims

1. A needle assembly, comprising:
a needle having a sharpened end and an opposing end, the needle being insertable through a base; and
a needle shield device, comprising:
an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and
an outer shield fixedly connected to the opposing end of the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield;

wherein during or after proximal displacement of the outer shield from the first position to the second position, interaction between portions of the inner and outer shields automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

2. The assembly according to claim 1, wherein:
the inner shield comprises a cantilevered latch beam with a shield latch thereon; and
the outer shield comprises a hub latch that engages the latch beam and prevents radially outward displacement of the latch beam to maintain connection between the inner shield and the base when the outer shield is disposed in the first position; and
when the outer shield is disposed in the second position, the hub latch engages the shield latch, thereby permitting radially outward displacement of the latch beam and preventing further proximal displacement of the outer shield relative to the inner shield.

3. The assembly according to claim 2, wherein the engagement of the hub latch and the shield latch also prevents distal displacement of the outer shield relative to the inner shield.

4. The assembly according to claim 2, wherein:
the inner shield further comprises an inner shield latch;
the outer shield comprises a hub beam; and
when the outer shield is disposed in the second position, the hub beam engages the inner shield latch to prevent distal displacement of the outer shield relative to the inner shield.

5. The assembly according to claim 4, wherein the inner shield latch is disposed on a cantilevered inner shield latch beam.

6. The assembly according to claim 4, wherein the hub beam is cantilevered.

7. The assembly according to claim 1, wherein:
the inner shield comprises an inner shield latch;
the outer shield comprises an outer shield latch; and
when the outer shield is disposed in the second position, the shield latch engages the inner shield latch to prevent distal displacement of the outer shield relative to the inner shield.

8. The assembly according to claim 7, wherein:
the inner shield comprises at least one cantilevered latch beam for selectively connecting the needle shield device to the at least one of the base and the fluid connector, the latch beam having a shield latch thereon;
the outer shield comprises a hub latch that engages the latch beam and prevents outward displacement of the latch beam to maintain connection between the inner shield and the at least one of the base and the fluid connector when the outer shield is disposed in the first position; and
when the outer shield is disposed in the second position, the hub latch engages the shield latch, thereby permitting outward displacement of the latch beam and preventing further proximal displacement of the outer shield relative to the inner shield.

9. The assembly according to claim 8, wherein the at least one cantilevered latch beam comprises a pair of retention beams, each having a recess for accommodating tubing of the fluid connector to connect the inner shield to the fluid connector.

10. The assembly according to claim 1, wherein:
the outer shield has a cavity therein for housing the inner shield when the outer shield is in the first position; and
the inner shield comprises a spring element disposed about the introducer needle, the spring element having a shield tip, wherein upon proximal displacement of the sharpened end of the needle past the shield tip when the outer shield displaces to the second position, the shield tip automatically displaces laterally to cover the sharpened end of the needle.

11. The assembly according to claim 10, wherein:
the spring element comprises a spring clip with latch tabs that connect with hub latches on the fluid connector, the spring clip having a retention hole disposed at a proximal end thereof and an additional hole disposed on a cantilevered arm of the spring clip and having a diameter greater than that of the retention hole, the respective centers of the retention hole and the additional hole being substantially axially aligned;
the needle comprises a bump sized to fit through the additional hole but not the retention hole;
the shield tip extends from the latch tabs and contacts the needle when the outer shield is in the first position, thereby biasing the spring clip; and
as the outer shield displaces to the second position,
the bump passes proximally through the additional hole and engages the retention hole; and
the sharpened end of the needle displaces proximally past the shield tip, thereby unbiasing the spring clip to laterally displace the shield tip to cover the sharpened end of the needle, and disengage the latch tabs from the hub latches of the fluid connector.

12. The assembly according to claim 11, wherein:
the proximal end of the spring clip, on which retention hole is disposed, comprises a top tab cantilevered with respect to a main body portion of the spring clip; and
the cantilevered arm of the spring clip comprises an L-shaped arm extending from a front of the top tab.

13. The assembly according to claim 11, wherein:
the proximal end of the spring clip, on which retention hole is disposed, comprises a top tab cantilevered with respect to a main body portion of the spring clip; and
the cantilevered arm of the spring clip comprises an L-shaped arm extending from a lateral side of the top tab.

14. The assembly according to claim 10, wherein:
the spring element comprises a biased spring having a plurality of slotted holes through which the needle passes, and a distal hole and a tip pocket at a distal end thereof; and
as the outer shield displaces to the second position, the biased spring expands along the needle until the sharpened end of the needle displaces proximally past the distal hole, thereby unbiasing the spring clip to laterally displace the tip pocket to cover the sharpened end of the needle.

15. The assembly according to claim 1, wherein when the outer shield is in the first position and the needle is fully inserted through the base and the cannula, the outer shield contacts the base.

16. The assembly according to claim 1, wherein the first and second shields are tubular.

17. A needle assembly, comprising:
a needle having a sharpened end and an opposing end, the needle being insertable through a base; and
a needle shield device, comprising:
an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and
an outer shield fixedly connected to the opposing end of the needle;

wherein during or after the outer shield is proximally displaced relative to the inner shield by a predetermined distance, interaction between portions of the inner and outer shields causes automatic release or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

18. A method comprising:
providing a needle assembly, the needle assembly comprising:
a needle with a sharpened end and an opposing end, the needle being insertable through a base; and
a needle shield device, comprising:
an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and
an outer shield fixedly connected to the opposing end of the needle; and


displacing the outer shield by a predetermined distance relative to the inner shield, and, by interaction between portions of the inner and outer shields during or after the outer shield is proximally displaced, releasing the inner shield from connection to the at least one of the base and the fluid connector.

19. A needle assembly, comprising:
a needle having a sharpened end and an opposing end, the needle being insertable through a base; and
a needle shield device, comprising:
a first shield; and
a second shield displaceable relative to the first shield between a first position, in which the sharpened end of the needle is exposed outside the first and second shields, and a second position, in which the sharpened end of the needle is shielded by the first and second shields;

wherein one of the first and second shields is connectable to at least one of the base and a fluid connector connectable to the base;
wherein one of the first and second shields is fixedly connected to the opposing end of the needle; and
wherein during or after proximal displacement of the second shield from the first position to the second position, interaction between portions of the first and second shields automatically releases or permits release of the one of the first and second shields from connection to the at least one of the base and the fluid connector.