# Patent

## Title
Fail safe point protector for needle safety flap

## Abstract

A method and device are disclosed for preventing a needle stick hazard in the event of a collapse of a protective needle flap of a portable drug pump. The device may include a needle guide, a secure space and/or a shield. A point of a needle is optionally deflected into a secure space upon collapse of the protective flap. The space may optionally be shielded. Optionally, the support linking the needle to the pump may pivot and/or translate. Optionally, there may be an exposing position wherein the needle protrudes through an opening in the flap. Optionally, the opening may be non-circular.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 13/429,840, filed Mar. 26, 2012, entitled “Fail Safe Point Protector For Needle Safety Flap,” now U.S. Pat. No. 9,072,827, issued Jul. 7, 2015, the disclosure of which is incorporated herein by reference in its entirety.


BACKGROUND OF THE INVENTION
The present invention, in some embodiments thereof, relates to a system and method for preventing a reexposure of point of a needle by deflecting the point and more particularly, but not exclusively, to a guide and/or a safety clip for deflecting and/or enclosing the point upon collapse of a needle protector flap.
International Patent Application WO 2011090955 to Oz Cabiri discloses a needle assembly adapted for fluid communication with a cartridge containing a substance to be delivered to a subject, the needle assembly is characterized by a biasing device arranged to apply a biasing force on a needle to cause the needle to protrude outwards of a housing to pierce the subject. A safety latch is movably mounted on the housing and formed with a needle opening to allow the needle to pass therethrough. The safety latch has a first position wherein the needle is aligned to pass through the needle opening and a second position wherein the safety latch is moved with respect to the housing and the needle is blocked by a portion of the safety latch distanced from the needle opening.
U.S. Pat. No. 5,300,045 and International Application WO 2008/014908 to Plassche discloses a stylet which is received in a needle cannula and is automatically capped in a guard body when the stylet is withdrawn from the cannula. The guard contains an arm which moves into blocking position with respect to the tip of the stylet when it is withdrawn from the cannula by following a cam surface on the cannula hub (either inside or outside the hub for different styles of needle cannulas). The arm may be spring biased, across a hole in the guard in which the stylet is slidably disposed into interfering relationship with the arm. The cam surface urges the arm to bring a portion thereof which protects the point of the tip of the stylet and captures it inside the guard. The arm and cam prevent removal of the stylet from the cannula until the tip is covered and protected by the guard, thereby automatically capping the tip of the stylet to prevent potentially dangerous, inadvertent, or accidental sticking of medical personnel.
U.S. Pat. No. 5,836,920 to Robertson discloses a guard for a hypodermic needle that includes a hub for attachment to a needle and a shield which can be attached to the hub. The shield is adapted to lie adjacent the needle and has a lip which projects outwardly to cover the tip of the needle. An enclosure for the tip of the needle is provided and located adjacent to the lip. The hub and the shield each includes complementary attachment mechanisms whereby the shield can be attached to the hub in first and second relative positions. In the first position, the needle can be used and the shield is capable of moving away from the needle to uncover the tip as the needle initially penetrates the body of a patient and of returning back toward the needle and again to cover the tip as the needle is withdrawn from the patient. By pulling the shield toward the hub in a direction substantially parallel to the longitudinal axis of the needle, the shield is attached to the hub in a second relative position wherein the tip of the needle is enclosed by the enclosure and thereby locks the shield in position with respect to the needle so that the shield cannot be flexed away from the needle to uncover the tip after use.
U.S. Published Patent Application, 2011/0282296 to Harms discloses a protective cap coupled to a syringe having a needle attached thereto. The protective cap may be pivoted to a position in alignment with the needle so that the protective cap substantially envelops the needle. A plug may be inserted into the cap to envelop or capture the needle within a hollow body of the plug to secure at least a tip of the needle.
Additional background art includes U.S. Published Patent Application 2010/0168683 to Oz Cabiri, U.S. Published Patent Application 2010/0234767 Sarstedt, U.S. Published Patent Application 2008/0208138 to Kiang, U.S. Published Patent Application 2003/0135159 to Daily, U.S. Published Patent Application 2002/0055711 to Lavi, U.S. Pat. No. 8,057,431 to Woehr, U.S. Pat. No. 7,854,723 to Hwang, U.S. Pat. No. 6,224,569 to Brimhall, and U.S. Pat. No. 4,929,241 to Kulli.
BRIEF SUMMARY OF THE INVENTION
According to an aspect of some embodiments of the present invention there is provided a device for preventing reexposure of a point of a needle projecting from a housing of an apparatus wearable by a recipient for delivering a drug to the recipient. The device may include a flap movably mounted to a housing of the apparatus. The flap may have a protecting position in which the flap may cover the point. The device may further include a secure space. The device may further include a guide integrated into the flap. The guide may be positioned relative to the point such that upon collapse of the flap the guide deflects the point into the secure space thereby preventing the reexposure of the point upon the collapse.
According to some embodiments of the invention, in the protecting position, the guide may be disposed at an incline to the needle. The incline may be at an angle of between 5 and 85 degrees to the needle
According to some embodiments of the invention, the device may further include a clip shielding the secure space.
According to some embodiments of the invention, after the collapse of the flap, the secure space may be shielded by a clip and/or the flap and/or a joint between the flap and the housing.
According to some embodiments of the invention, the device may further include a pivot linking the needle and the housing. The pivot may be positioned to rotate upon deflection of the needle.
According to some embodiments of the invention, the device may further include a translating support linking the needle and the housing. The translating support may be positioned to translate upon deflection of the needle.
According to some embodiments of the invention, the guide may be positioned to bend the needle when the needle is deflected.
According to some embodiments of the invention, the guide may include a channel positioned to direct the point of the needle toward the secure space.
According to some embodiments of the invention, the guide may include a barrier positioned to direct the point to the secure space.
According to some embodiments of the invention, the flap may be pivotally connected to the housing of the apparatus.
According to some embodiments of the invention, the flap may have an exposing position wherein the needle protrudes through an opening in the flap. The opening may be non-circular.
According to some embodiments of the invention, the device may further include a biasing device for moving the flap from the exposing position to the protecting position.
According to some embodiments of the invention, in the protecting position, the opening may be not aligned with the point.
According to an aspect of some embodiments of the present invention there is provided a device for preventing reexposure of a point of a needle projecting from a housing of an apparatus. The apparatus may be wearable by a recipient. The apparatus may deliver a drug to the recipient. The device may include a flap movably mounted to the housing of the apparatus. The flap may have at least three positions: an exposed position in which the needle protrudes through an opening in the flap; and a protecting position in which the flap covers the point and the point is not aligned with the opening; and a collapsed position. The device may also include a secure location in the collapsed position. The device may also include a guide integrated into the flap. The guide may be positioned relative to the point of the needle such that upon movement of the flap from the protecting position to the collapsed position the guide deflects the point into the secure space thereby preventing the reexposure of the point upon collapsing of the protective flap.
According to some embodiments of the invention, in the protecting position, the guide may be disposed at an incline to the needle.
According to some embodiments of the invention, the incline between the guide and the needle in the protected position may be at an angle of between 5 and 85 degrees.
According to some embodiments of the invention, the device may further include a clip shielding the secure space.
According to some embodiments of the invention, after the collapse of the flap, the secure space may be shielded by a clip and/or the flap and/or a joint between the flap and the housing of the apparatus.
According to some embodiments of the invention, the device may further include a pivot linking the needle and the housing. The pivot may be positioned to rotate when the needle is deflected.
According to some embodiments of the invention, the device may further include a translating support linking the needle and the housing. The translating support may be positioned to translate upon deflection of the needle.
According to some embodiments of the invention, the guide may be positioned to bend the needle upon the deflection of the needle.
According to some embodiments of the invention, the guide may include a channel positioned to direct the point of the needle toward the secure space.
According to some embodiments of the invention, the guide may include a barrier positioned to direct the point of the needle toward the secure space.
According to some embodiments of the invention, the flap may be pivotally connected to the housing.
According to some embodiments of the invention, the device may further include a biasing device for moving the flap from the exposing position to the protecting position.
According to some embodiments of the invention, the needle opening in the flap may be non-circular.
According to an aspect of some embodiments of the present invention there is provided a method of preventing reexposure of a point of a needle projecting from a housing of a portable injection apparatus upon collapse of a protective flap. The method may include covering the point after use of the apparatus by moving the protective flap to a protecting position, and deflecting the point into a secure space upon a collapse of the protective flap to prevent the reexposure of the point.
According to some embodiments of the invention, the method may further include shielding the secure space.
According to some embodiments of the invention, the method may further include pivoting the needle around a needle support when the needle is deflected. The needle support may link the needle and the housing.
According to some embodiments of the invention, the method may further include translating a needle support that links the needle and the housing upon the deflection of the needle.
According to some embodiments of the invention, the method may further include bending the needle upon the deflection of the needle.
According to some embodiments of the invention, the method may further include pivoting the protective flap from an exposing position wherein the needle protrudes through an opening in the protective flap to the protecting position.
According to an aspect of some embodiments of the present invention there is provided a device for preventing a needle stick by a point of a needle projecting from a housing of an apparatus wearable by a recipient for delivering a drug to the recipient. The device may include a flap movably mounted to a housing of the apparatus. The device may also include a non-circular opening in the flap. The needle may project through the non-circular opening when the flap is in an exposing position. The device may further include a biasing mechanism for moving the flap to a protecting position in which the flap covers the point and the non-circular opening is not aligned with the point.
According to an aspect of some embodiments of the present invention there is provided a device for preventing a needle stick by a point of a needle projecting from a housing of an apparatus wearable by a recipient for delivering a drug to the recipient. The device may include a flap movably mounted to a housing of the apparatus and an opening in the flap. The needle may project through the opening when the flap is in an exposing position. The device may also include a biasing mechanism for moving the flap to a protecting position in which the flap covers the point of the needle. In the protecting position, the opening may not be aligned with the point. The device may also include a translating needle support linking the needle and the housing.
According to an aspect of some embodiments of the present invention there is provided a device for preventing a needle stick by a point of a needle projecting from a housing of an apparatus wearable by a recipient for delivering a drug to the recipient. The device may include a flap movably mounted to a housing of the apparatus and an opening in the flap. The needle may project through the opening when the flap is in an exposing position. The device may also include a biasing mechanism for moving the flap to a protecting position in which the flap covers the point of the needle. In the protecting position, the opening may not be aligned with the point. The device may also include a pivoting needle support linking the needle and the housing.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.



BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
In the drawings:
FIG. 1a is a flow chart illustrating an exemplary method according to the current invention;
FIG. 1b is a flow chart illustrating an exemplary method according to the current invention including extra optional steps;
FIG. 2a is a simplified cutaway illustration of an exemplary embodiment drug pump attached to a recipient with a flap in an exposing position;
FIG. 2a′ is a perspective illustration of an exemplary embodiment drug pump with a flap in an exposing position;
FIG. 2b is a perspective view of the embodiment of FIG. 2a with the flap in a protecting position;
FIGS. 2c and 2c′ are a close up cutaway view of the flap after collapse;
FIG. 2d is a perspective view of the flap;
FIG. 3a is a perspective view of the embodiment of FIG. 2 with the flap in a protecting position;
FIG. 3b is a view of the embodiment of FIG. 2 with the flap in a protecting position, from another perspective;
FIG. 3c is a cutaway illustration of the embodiment of FIG. 2 with the flap in the protecting position;
FIG. 3d is a perspective view of the base of the apparatus of FIGS. 2a-d, FIGS. 3a-c with the flap in the exposing position showing the form of the needle opening.
FIG. 3d′ is a close up base view of oval A of FIG. 3d showing the form of the needle opening.
FIG. 4 is a cutaway view of the embodiment of FIGS. 2a-d, 3a-d after collapse of the protective flap;
FIG. 4′ is an expanded view of circle B of FIG. 4;
FIG. 5a is a cutaway view of an additional embodiment of an injector with a flap in a protecting position;
FIG. 5b is a cutaway view of the embodiment of FIG. 5a after collapse of the flap;
FIG. 6a is a cutaway view of a further additional embodiment of an injector with a flap in a protecting position;
FIG. 6b is a cutaway view of the embodiment of FIG. 6a after collapse of the flap;
FIG. 7 is a perspective view of a further alternative embodiment of a flap, and
FIG. 8 is a perspective view of a further alternative embodiment of a guide.



DETAILED DESCRIPTION OF THE INVENTION
The present invention, in some embodiments thereof, relates to a system and method for preventing a reexposure of point of a needle by deflecting the point and more particularly, but not exclusively, to a guide and/or a safety clip for deflecting and/or enclosing the point upon collapse of a needle protector flap.
A portable drug pump may include a protective flap for covering a protruding needle. Under certain conditions, the protective flap may collapse, reexposing the needle. In some embodiments, the present invention may include an optional guide for deflecting the needle to a secure space thereby preventing reexposure of the needle in the event of collapse of the flap. An optional enclosure may shield the secure space.
In some embodiments, in a protecting position, when the flap is in the protecting position, the guide may be disposed at an incline to the needle. The angle of include between the deflective guide and the needle may determine the direction to which the point will be deflected upon collapse of the flap. The angle between the needle and the deflective guide may optionally range between 5° to 85°. The guide may take a form of a flat plate and/or the guide may include walls and/or a channel for directing the needle tip to the secure space and/or the guide may have a concave form for directing the needle tip.
In some embodiments, deflecting the point will include bending a needle. Additionally or alternatively, deflecting the point may include pivoting the needle and/or causing a translation of the support of the needle.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
FIG. 1a is a flow chart illustrating a simplified example of a method for preventing reexposure of a point when a protecting flap is subject to a collapse failure. Such a failure may result, for example, from a strong blow to the flap.
An injection apparatus may be used, for example, by a patient who needs to receive a drug by subcutaneous injection. The patient may prefer to receive the injection at home using the injection apparatus rather than traveling to a doctor. The recipient may wear the injector by optionally attaching 162 the apparatus to his body. Attachment 162 may be, for example, by means of an adhesive on the base of the injector.
In some embodiments, after attachment 162 the injector may optionally insert 164 a hypodermic needle subcutaneously into the recipient. The injection apparatus may then optionally inject 166 the drug through the needle into the recipient. After injection 166, the patient optionally removes 168 the injection apparatus.
In some embodiments, after removal 168, the needle will remain protruding from the injection apparatus, presenting a needle stick hazard. In order to protect people from the needle, the injection apparatus may optionally include a protective flap for covering 170 the needle.
When the flap is in a protecting position, at times, a strong force may collapse 172 the protecting flap. For example, the patient may throw the apparatus into the garbage and then later compact the garbage with his foot. The compaction force may collapse the protective flap of the injection apparatus, possibly reexposing the sharp tip of the needle.
In some embodiments, the flap may include an optional fail-safe guide to prevent reexposure of the needle in the event of collapse 172 of the flap. The guide may optionally deflect 174 a point of a needle into a secure space, reducing the likelihood of a needle stick injury.
FIG. 1b is a flow chart illustrating a method of averting a needle stick including optional steps. A method of averting needle sticks may include one, some or all of the optional steps.
An injection apparatus is supplied in a protecting 170′ position wherein a needle protecting flap covers the point. When a strong force collapsed 172′ the protecting flap, the point is optionally deflected 174′ into a secure space.
In the exemplary embodiment of FIG. 1b, the point may optionally be on a tip of a needle. The needle may optionally be bent 176 during deflection 174′. Alternatively or additionally, the needle may be mounted on a movable support and the needle may pivot and/or translate while the point is being deflected 174′.
In some cases, a shield (for example a clip) may be included in the injector for shielding 178 the secure space. Shielding 178 the secure space may prevent needle sticks, for example, when the flap breaks and/or a person pushes his finger under the flap and/or when the displacement of the flap uncovers the needle and/or when the point is displaced away from under the flap by bending and/or pivoting and/or translating. Alternatively or additionally, the needle and/or the guide and/or the clip may hold 180 the needle protective flap in a closed position, thereby shielding 178 the needle with the flap.
FIGS. 2a, 2a′, 2b, 2c, 2c′, 2d, 3a, 3b, 3c, 3d, 3d′, 4 and 4′ are views of an exemplary embodiment 210 of a portable drug injector apparatus and a needle protection flap 222. In embodiment 210, flap 222 is optionally pivotally mounted to a base of the apparatus housing.
FIGS. 2a-c are a simplified illustration of a needle protector in various positions. Particularly, FIGS. 2a, a′ illustrate the injector and flap in an exposing position, wherein needle 216 is exposed. For example, in FIG. 2a, flap 222 is shown in the exposing position while the apparatus is injecting a drug into a flesh 205 of a recipient. FIG. 2b illustrates the injector in a protecting position. FIGS. 2c, c′ illustrate the injector after collapse of protective flap 222. Particularly, FIG. 2c′ illustrates a secure space 256 and a guide 252 for deflecting a point 232 of needle 216 into the secure space. FIG. 2 also shows an optional clip 254 shielding secure space 256.
FIG. 2a, a′ illustrates protective flap 222 in an exposing position (for example while injecting a drug into a patient). In FIG. 2a, the embodiment 210 is shown attached to a recipient. Needle 216 projects out of a needle opening 229 in flap 222 and is inserted into flesh 205. During injection, the base of the injector is typically held against the skin of the recipient by an adhesive. In the exposing position, flap 222 is optionally held flush to the base of the injector housing by pressure against skin of the recipient. Needle 216 is optionally locked in the protruding position. The drug may be administered to the recipient, for example, via needle 216 and/or a cannula.
Embodiments of the invention are described with reference to a needle alone, but apply as well to a needle disposed in a cannula or any other delivery device. The term “needle” is used throughout the specification and claims to encompass all such delivery devices and/or sharp implements.
Embodiment 210 typically includes a motor, a battery and a control unit (all not shown) within the housing of the apparatus. After needle 216 has penetrated the skin of the patient, the control unit controls operation of the motor to administer a controlled amount of the substance to the patient at a controlled rate of delivery. Of course, the needle assembly of the present invention can be used in other applications and does not have to be used with a controlled motorized delivery system.
When injection has finished the injector is lifted away from the skin of the recipient and flap 222 pivots away from the base of the apparatus to a protecting position as illustrated, for example, in FIG. 2b (and in more detail in FIGS. 3a-c). In the protecting position, flap 222 covers the point of needle 216 protecting from a needle stick hazard.
There is a concern that if flap 222 is pivoted back toward the injector housing with a force sufficient to bend needle 216, then point 232 may be reexposed creating a needle stick hazard. For example, in FIGS. 2b and 2c if needle 216 were bent leftward toward the open space between flap 222 and the housing base without any protective mechanism a person could get stuck if he pushed his fingers under the flap, as shown in FIG. 2c. Embodiment 210 includes a guide and clip to deflect and shield needle 216 and prevent such needle sticks as illustrated, for example, in FIG. 2c′. 
FIG. 2c′ is an expanded cutaway illustration of the exemplary embodiment of flap 222. Particularly, FIG. 2c′ illustrates an optional guide 252 and an optional clip 254 and an optional secure space 256, which prevent reexposure of needle 216 in the event of collapsing of flap 222. Particularly, upon collapse of flap 222, guide 252 pushes needle 216 into secure space 256. Optionally, clip 254 shields secure space 256. (See below more detailed discussion of the exemplary embodiment of guide 252, clip 254, and space 252 in reference to FIGS. 4 and 4′.)
FIG. 2d shows a perspective view of flap 222.
In FIGS. 3a-c, embodiment 210 is shown in the protecting position. After finishing the drug administration, embodiment 210 is typically lifted off the recipient's body. As the injector is lifted, biasing device 227 to pushes flap 222 away from the base of the apparatus. Flap 222 pivots into the protecting position. In FIGS. 3a-c, flap 222 is shown in the protecting position, covering point 232.
As illustrated, for example, in FIG. 3c, as flap 222 moves from the exposing position (FIGS. 2a, a′) into the protecting position (FIGS. 2b, 3a-c), a needle opening 229 optionally follows a curved trajectory 330 (downward and rightward in FIG. 3c). As opening 229 moves along trajectory 330, needle 216 is optionally flexed elastically rightward. When opening 229 passes below point 232, needle 216 optionally snaps back leftward to its un-stressed shape. As illustrated, for example, in FIG. 3c, in its unstressed shape, needle 216 optionally remains locked protruding out of the housing. Needle 216 is no longer aligned with needle opening 229. Needle 216 optionally serves as a prop, preventing flap 222 from returning to the exposing position. Flap 222 serves as a protector blocking point 232.
In FIG. 3d, d′, it is seen that, in exemplary embodiment 210, opening 229 is optionally non-circular. In some embodiments, the form of needle opening 229 may be selected to adjust resistance to pivoting of flap 222 from the exposing position (FIGS. 2a, a′, 3d, d′) to the protecting position (FIGS. 3a-c). Additionally or alternatively, the form of needle opening 229 may be selected to adjust stability of flap 222 in the protecting position.
In embodiment 210, opening 229 optionally includes a linear duct 240. In embodiment 210, duct 240 is optionally directed at an angle 220 of approximately 55° with a pivoting axis 242 of flap 222.
In exemplary embodiment 210, as flap 222 pivots from the exposing position (for example, as illustrated in FIG. 2a, a′, 3d, d′) into the protecting position (for example, as illustrated in FIGS. 3a-c), needle 216 slides along duct 240 flexing to remain in opening 229. Once flap 222 has pivoted far enough, point 232 passes through opening 229 and needle 216 returns to its un-stressed shape (as illustrated, for example, in FIG. 3c).
In embodiment 210, the resistance of flap 222 to pivoting may increase as the required flexing of needle 216 increases. The flexing required of needle 216 may depend on the length and angle 220 of duct 240. Generally, the resistance may decrease as angle 220 increases from 0° to 90°.
In the protected mode of embodiment 210 (FIG. 3a-c), as long as point 232 is not aligned with opening 229, needle 216 acts as a prop to stabilize flap 222. The likelihood that point 232 will unintentionally realign with opening 229 may increase as angle 220 increases from 0° to 90°.
Optionally, angle 220 may range between 5° and 85°. In many embodiments, angle 220 may range between 40° and 80°. In some embodiments, duct 240 may be curved and/or have a non-uniform width. Optionally opening 229 may have a different form. More generally, the flexing required of needle 216 may depend on the angle and distance between the un-stressed location of needle 216 and the contact point between needle 216 and opening 229 at the point of maximum flexing. More generally, the likelihood of unintentional alignment, in the protecting position, between needle 216 and opening 229 may depend on the distance between the unstressed location of point 232 and the closest edge of opening 229, in the protecting position.
FIG. 3c illustrates an exemplary embodiment of an optional guide 252 and an optional enclosure, safety clip 254. Guide 252 is optionally integrated into flap 222. For example, guide 252 may be attached to flap 222 and/or it may be integral to flap 222.
Under some conditions flap 222 may collapse. For example, a strong force may cause flap 222 to collapse and pivot towards the base of the apparatus. As flap 222 pivots, guide 252 deflects point 232 into a secure space 256 of clip 254 (as shown in FIGS. 4 and 4′), preventing a needle stick hazard.
In some embodiments, clip 254 optionally shields secure space 256. Additionally or alternatively, clip 254 may clasp point 232.
In the protecting position of FIG. 3a-c, guide 252 is optionally disposed at an approximately 45° angle 318 to the axis of needle 216 and point 232. In some embodiments, guide may be disposed at an angle 318 ranging between 5° and 85° to point 232.
FIG. 4 shows embodiment 210 in after collapse of flap 222. FIG. 4′ shows an enlarged view of circle B. In FIGS. 4, and 4′ guide 252 has deflected point 232 into protected secure space 256. In embodiment 210, guide 252 is optionally configured so that deflection is in the direction away from the joint between flap 222 and the injector housing. In alternative embodiments, the needle may be defected towards the joint and/or at an angle to the pivoting connection.
In some embodiments, Clip 254 may be optionally configured to clasp bent needle 216 thereby securing protective flap 222 in a closed position. In the closed position, flap 222 may shield point 232. In some embodiments clip 254 may retain point 232 inside of secure space 256. For example, clip 254 may grasp needle 216 and/or point 232 (with a clasping force). Alternatively or additionally clip 254 may enclose and shield point 232 but not grasp needle 216 or point 232.
The composition of clip 254 and/or guide 252 may include plastic, metal, paper, wood and/or another suitable material.
FIG. 5a,b illustrate another exemplary embodiment 510 of an apparatus. In embodiment 510, upon collapse of an optional protective flap 522, a needle 516 pivots into a secure space 556.
In embodiment 510, needle 516 is optionally mounted on a pivoting support 558. FIG. 5a shows embodiment 510 in a protecting position. FIG. 5b shows embodiment 510 after collapse of flap 522.
In FIG. 5a, a point 532 is covered by flap 522. An optional guide 552 is optionally inclined at an angle 518 with respect to point 532. Flap 522 is held in the protecting position by an optional biasing device 527 and by needle 516.
Under some conditions flap 522 may be forced to pivot back towards the base of the apparatus. As flap 522 pivots toward the base of the apparatus, guide 552 deflects point 532 into a secure space 556. At first, pivoting support 558 allows needle 516 to pivot without bending. As flap 522 collapses further, point 532 collides with the back side of an optional clip 554 forcing needle 516 to bend as shown in FIG. 5b. 
FIGS. 6a,b illustrate another exemplary embodiment 610 of an apparatus having fail-safe needle protection according to the current invention. Optionally, in embodiment 610, upon collapse of flap 622, point 632 is deflected into a secure space 656 formed at the joint between flap 622 and the housing of the apparatus.
In FIGS. 6a,b, a needle 616 is mounted on an optional sliding pivoting support 658.
Pivoting and translating of support 658 allows a point 632 to be deflected into secure space 656 without bending needle 616.
FIG. 6a shows embodiment 610 in a protecting position. FIG. 6b shows embodiment 610 after collapse of an optional protective flap 622.
In FIG. 6a, a point 632 is covered by flap 622. Flap 622 is held in a protecting position by an optimal biasing device 627 and by needle 616. An optional guide 652 is optionally held inclined at an angle 618 with respect to point 632. In embodiment 610, the inclination of guide 652 is optionally opposite that of flap 622.
Flap 622 may sometimes be forced to pivot back towards the base of the apparatus. As flap 622 pivots toward the base of the apparatus, guide 652 deflects point 632 away from the opening between flap 622 and the base of the apparatus. Point 632 is deflected towards secure space 656 formed by the joint between flap 622 and the housing base. Support 658 optionally pivots and translates along an optional track 660 allowing needle 616 to pivot towards secure space 656. As flap 622 continues to collapse, point 632 is pushed by guide 652. Eventually, needle 616 pivots without bending until it lies flat up against guide 652 parallel to the base of the apparatus. In FIG. 6b, point 632 is located in secure space 656 shielded by the base of the apparatus and flap 622.
FIG. 7 is a close up perspective view of a further exemplary embodiment of a protective flap 722. Visible in the drawing are exemplary embodiments of a pivoting axis 742 and a needle opening 729 and a guide 752 and a shielding clip 754 and a secure space 756 and a biasing element 727. Embodiment 722 also includes barriers 762 forming a channel for preventing a needle from twisting sideward during a collapse of flap 722.
FIG. 8 is a close up perspective view of an exemplary embodiment of a guide 852. Visible in the drawing are exemplary embodiments of a needle opening 829 and a shielding clip 854 and a secure space 856 and a channel 860 for directing the a needle point to secure space 856 and/or for preventing a needle from twisting sideward during a collapse of a protecting flap. Alternatively or additionally channel 860 may have a non-rectangular shape (for example, it could have a wedge shape). Alternatively or additionally channel 860 could have a non-rectangular cross-section (for example it could have a V shaped cross section). Alternatively or additionally, channel 860 could be formed by a concave shape of guide 856.
It is expected that during the life of a patent maturing from this application many relevant technologies will be developed and the scope of the terms is intended to include all such new technologies a priori.
As used herein the term “about” refers to ±10%.
The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”.
The term “consisting of” means “including and limited to”.
The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

## Claims

1. An injection apparatus wearable by a recipient for delivering a drug to the recipient, the injection apparatus comprising:
a housing having a base, the base engaging skin of the recipient during injection;
a generally linear needle having a needle point projecting from the housing;
a flap pivotably mounted to the base of the housing, the flap including a bottom wall and a clip extending therefrom, a secure space located between the clip and bottom wall, the flap having:
an exposed position, generally co-planar with the base, wherein at least the needle point is aligned with and protrudes through an aperture in the flap,
a protecting position, wherein the flap is pivoted away from the exposed position in a direction away from the base of the housing and covers the needle point, such and the needle point is positioned between said flap and said base and is not aligned with the aperture, and
a collapsed position, wherein the flap is pivoted toward the base of the housing from the protecting position;

wherein upon pivoting of the flap from the protecting position to the collapsed position, the flap deflects the needle point into the secure space within the flap while bending the needle to a non-linear orientation, thereby preventing re-exposure of the needle point beyond the flap.

2. The injection apparatus of claim 1, further comprising a guide attached to the flap, the guide being positioned relative to the needle point such that upon pivoting of the flap from the protecting position to the collapsed position, the guide deflects the needle point into the secure space within the flap.

3. The injection apparatus of claim 2, wherein the guide is integrated into the flap.

4. The injection apparatus of claim 2, wherein the guide comprises one of a plate, oriented at an incline to the needle point in the protecting position of the flap, or a concave plate within the flap, for deflecting the needle point into the secure space within the flap.

5. The injection apparatus of claim 1, further comprising a biasing device positioned between the flap and the housing for moving the flap from the exposed position to the protecting position.

6. The injection apparatus of claim 1, wherein movement of the flap from the exposed position to the protecting position elastically flexes the needle out of the aperture.

7. The injection apparatus of claim 1, wherein the aperture is non-circular.

8. The injection apparatus of claim 7, wherein the aperture includes a linear duct.

9. The injection apparatus of claim 8, wherein upon movement of the flap from the exposed position to the protecting position, the needle initially slides along the duct prior to retracting from the aperture and misaligning therewith.