EA043488B1 - PALM ACTUATED DRUG DELIVERY DEVICE - Google Patents

Description

Cross-references to related applications

This application is a continuation in part of U.S. Patent Application No. 12/905572, filed October 15, 2010, which claims priority under provisional patent applications

U.S. Nos. 61/361983, filed July 7, 2010, and 61/252378, filed October 16, 2009, the contents of which are incorporated herein by reference in their entirety.

Field of technology

The invention essentially relates to methods and devices for the delivery of drugs by the parenteral route. The devices are designed for manual delivery of drugs with confirmation of completion of the drug delivery process. The devices provide an easy-to-use, enhanced safety system with audio or other feedback to the user notifying that drug delivery is either in progress, complete, or both, thereby avoiding under-dose or wasted drug. , and also provides an easy-to-use enhanced security system.

Prerequisites for creating the invention

For many years, parenteral drug administration was carried out in the only generally accepted way, namely with a syringe and needle. A syringe contains a specified amount of a drug that is either already in the syringe (if the syringe is sold pre-filled with the drug) or is introduced into the syringe by being drawn into the syringe from a vial or other container. Syringes have become widespread due to their low production costs and simple and convenient design. However, from the user's point of view, they have a number of disadvantages.

One disadvantage is that many patients are afraid of needles. In cases where self-administration of medications is necessary, such as in treatments that require multiple daily injections, patients may avoid administering the medication as prescribed due to fear of needles, pain typically associated with injections, lack of dexterity required to properly administration of the drug using a needle and syringe, or other similar factors. For some people with visual, motor, or sensory impairments, self-administration of medication using a needle and syringe presents additional challenges that may prevent them from getting the medication they need.

In addition, the use of needles and syringes is associated with safety and disposal problems affecting not only the patient, but also the people around him: in this case, in addition to stereotypes regarding drug treatment regimens using needles and syringes, we are talking about contaminated needles, accidental injections , cross-infection, etc. However, despite these disadvantages, the incentive for many patients to use needles and syringes to deliver essential medications is the ability to control the insertion of the needle and the rate of delivery of the drug by pressing the plunger of the syringe and, therefore, the ability to control the pain and discomfort associated with such type of drug injection.

Over time, improvements have been made to facilitate self-administration of the drug. Such improvements include reducing the thickness of the needles with improving tip geometry, which reduces pain. To minimize the likelihood of an accidental needle stick, safety syringes are used in which the needle remains closed before, after, or both before and after use. In addition, options were proposed to improve the ergonomics of the syringe design, requiring less skill for accurate and safe self-administration of the drug using a needle and syringe.

To improve dosing accuracy, pre-filled disposable devices with a body designed similar to a ballpoint pen have been developed, and in order to relieve the patient of fear and address the issue of safety, auto-injectors are used, where the needle is hidden from the patient either by retraction or by placing a protective shield around the needle. cap.

Although such modifications have improved needle and syringe drug delivery, ergonomic designs, pen syringes, and auto-injectors remain essentially similar to the original needle and syringe concept, thereby limiting the degree of acceptability for patients requiring self-administration of medication. Current systems use a form factor that utilizes the common skin-fold-and-prick injection technique, with the user holding the device with their hand and placing their thumb on the activation button.

Modern auto-injectors rely on a mechanical system to control the delivery of drugs into the body. Because such a system is highly dependent on the specific mechanical design of the autoinjector, patients may require specialized training in the use of the device and remain at risk for inaccurate dosing. This situation gets worse in

- 1 043488 cases of delivery of very expensive drugs, the administration of which must be carried out once a week or less.

The typical way to use modern auto-injectors involves the patient holding the device, which is pressed against the skin, for a few seconds while the device delivers the drug. Many users, particularly older users, may experience shoulder or arm fatigue caused by uneven pressure from the device on the skin, or they may remove the device from the injection site prematurely. Any of the two listed situations can lead to inaccurate dosing, excessive consumption of the drug, increased discomfort, etc. In any case, modern devices and methods that include or are developed based on the traditional system of syringes and needles have disadvantages that reduce the effectiveness of the prescribed drug treatment regimen.

Finally, as with any medical device or health care service, the cost of all commonly used components of the treatment regimen must be considered. Although the use of drug vials to fill empty syringes during or shortly before drug administration is perhaps the most cost-effective solution, it creates the additional possibility of wasting or wasting expensive medication. If the storage conditions of the drug involve the use of low temperatures, each time it is removed and re-placed in the cooling device before filling the syringe and thereafter, the quality of the drug deteriorates, resulting in a decrease in the expected effectiveness if the amount of drug contained in the ampoule is designed for delivery over a long period of time. Although prefilled syringes are more reliable and convenient, they also have the disadvantages previously listed.

For devices such as prefilled auto-injectors, they are typically designed for use with a wide range of medications, but are specifically designed for use with only one drug. Because such devices rely on mechanical systems incorporating springs to control the rate of drug injection, many drugs that have varying viscosities or require refrigeration and have significant changes in viscosity as a result of temperature changes are delivered either too quickly or too slowly due to a predetermined spring pressure. force provided by the design of the auto-injector. In many cases, too low a spring force results in incomplete delivery of the drug, removal of the device before completion of delivery, or increased user pain and discomfort due to a prolonged period of insertion of the injection device into the patient. On the other hand, too high a spring force results in delivery of the drug too quickly, which causes degradation of the drug, may cause syringe breakage, or pain at the injection site due to the rapid delivery of acidic drug or the pressure gradient under the skin or vein.

Thus, there is good promise for improvements in episodic parenteral drug delivery that will help overcome needle fear, reduce patient pain, and improve the safety, reliability, and effectiveness of many drug treatment regimens.

Summary of the invention

In accordance with one embodiment, a device configured to administer a medicament may include a lower housing member that includes a housing retainer and a syringe secured to the lower housing member and configured to hold the medicinal product. The syringe may include a needle configured to be inserted into tissue. The device may further comprise a needle guard configured to move relative to the lower housing element along a first direction from a first position to a second position to expose the needle, and an upper housing element secured relative to the lower housing element. The upper housing member may be configured to receive manual force and move relative to the lower housing member along a second direction opposite to the first direction from a pre-use position to a dispensing position in response to the manual force. The device may further comprise a piston rod carried by the upper housing member, movable with the upper housing member to extend relative to the syringe when the upper housing member moves along the second direction. Extension of the piston rod relative to the syringe may cause medication to flow out of the syringe needle. The housing lock may be configured to lock the upper housing member and then be removable when the upper housing member is in the pre-use position to prevent movement of the upper housing member to the dispensing position and movement of the needle guard to the second position may cause the lock to be released, whereby allowing the upper housing member to move from the first position to the second position.

- 2 043488

Brief description of drawings

The above brief description, as well as the following detailed description of a preferred embodiment of the invention, will be more clearly understood when read in conjunction with the accompanying drawings. To illustrate the present disclosure, preferred embodiments are shown in the drawings. However, it should be understood that the application of the present invention is not limited to the specific embodiments and methods given, and in this regard, reference is made to the claims of the present invention. The drawings show the following.

In fig. 1A is a side elevation view of an embodiment of the present invention.

In fig. 1B is a side view of the embodiment of the invention shown in FIG. 1A, after removing the cap.

In fig. 1C is a side view of the embodiment of the invention shown in FIG. 1B, after pressing the lock button.

In fig. 1D is a side view of the embodiment of the invention shown in FIG. 1C, after retracting the needle guard and exposing the needle.

In fig. 2A is a side view of the embodiment of the invention shown in FIG. 1D, during drug injection.

In fig. 2B is a side view of the embodiment of the invention shown in FIG. 2A, after completing the drug injection.

In fig. 2C is a side view of the embodiment of the invention shown in FIG. 2B, after extending the needle guard and hiding the needle.

In fig. 3 is an exploded view of the embodiment of the invention shown in FIG. 1A.

In fig. 4 is a cross-sectional view of the embodiment shown in FIG. 1A.

In fig. 5 is a partial cross-sectional view of the embodiment shown in FIG. 1A, which shows the latch.

In fig. 6 is a partial cross-sectional view of a portion of the embodiment shown in FIG. 1A, which shows the latch.

In fig. 7 is a cross-sectional view of the embodiment shown in FIG. 2A.

In fig. 8 is a cross-sectional view of the embodiment shown in FIG. 2B.

In fig. 9 is a cross-sectional view of the embodiment shown in FIG. 2C.

In fig. 10A is a side view of another embodiment of the present invention.

In fig. 10B is a side view of the embodiment of the invention shown in FIG. 10A, after removing the cap.

In fig. 10C is a side view of the embodiment of the invention shown in FIG. 10B, after retracting the needle guard and exposing the needle.

In fig. 11A is a side view of the embodiment of the invention shown in FIG. 10C, during the injection of the drug.

In fig. 11B is a side view of the embodiment of the invention shown in FIG. 11A, after completion of the drug injection.

In fig. 11C is a side view of the embodiment of the invention shown in FIG. 11B, after extending the needle guard and hiding the needle.

In fig. 12 is an exploded view of the embodiment of the invention shown in FIG. 10A.

In fig. 13A is a perspective view of the lower housing member of the embodiment of the invention shown in FIG. 10A.

In fig. 13B is a perspective view of the middle housing member of the embodiment of the invention shown in FIG. 10A.

In fig. 14 is a partial cross-sectional view of a portion of the upper and middle housing members of the embodiment of the invention shown in FIG. 10A.

In fig. 15 shows the locking mechanism of the embodiment shown in FIG. 10A.

In fig. 16 shows another locking mechanism of the embodiment shown in FIG. 10A.

In fig. 17A is a cross-sectional view of a portion of the embodiment illustrated in FIG. 10A.

In fig. 17B is a perspective view of a portion of the lower housing member of the embodiment shown in FIG. 10A.

In fig. 18 is a cross-sectional view of the device shown in FIG. 10A.

In fig. 19 is an exploded side view of yet another embodiment of the present invention.

In fig. 20 is a side cross-sectional view of another embodiment of the present invention before use.

- 3 043488

In fig. 21A is a perspective view of an alternative lower housing member configuration of the embodiment shown in FIG. 10A.

In fig. 21B is a perspective view of an alternative embodiment of the lower housing member shown in FIG. 10A.

In fig. 21C is a cross-sectional view of a portion of the lower housing member shown in FIG. 21B.

In fig. 22A is a front perspective view of yet another embodiment of a drug delivery device in a position prior to use, the drug delivery device including a lower housing member, a middle housing member attached to the lower housing member, an upper housing member movably coupled to the middle housing member a housing member from a pre-use position to a dispensing position, and a needle guard configured to be movable relative to the lower housing member from a first position to a second position and then to a final position.

In fig. 22B is a front elevation view of the drug delivery device shown in FIG. 22A, in a position prior to use, with the upper housing member substantially covering the middle housing member.

In fig. 22C is a cross-sectional view of the drug delivery device shown in FIG. 22A.

In fig. 22D is a cross-sectional view of the drug delivery device shown in FIG. 22B, with the needle guard in the second position, whereby the needle is exposed.

In fig. 22E is a cross-sectional view of the drug delivery device shown in FIG. 22D, with the needle cap in its final position, whereby the needle is contained inside.

In fig. 23 is an exploded view of the drug delivery device shown in FIG. 22A, including a clamp cap, a main body and a top body skirt, a syringe holder, a syringe and a needle cap.

In fig. 24A is a bottom perspective view of the main body of the upper housing member shown in FIG. 23, the main body of the upper housing member including a pair of guides, each of which defines a support surface and a guide channel.

In fig. 24B is a side elevation view of the main body of the upper housing member shown in FIG. 24A.

In fig. 24A is a cross-sectional view of the skirt shown in FIG. 23, the skirt including a body and four friction members, defined as slats, that extend from the body.

In fig. 25A is a perspective view of the middle housing member of FIG. 23, the middle housing element including a side wall and four friction elements formed by cantilever portions that extend from the side wall.

In fig. 25B is a detailed side elevational view of one of the cantilevers of the middle housing member shown in FIG. 25A.

In fig. 25C is a cross-sectional view of the drug delivery device shown in FIG. 22A, which depicts the skirt ribs in contact with the cantilever portions of the middle body member as the upper body member is moved along the middle body member from the pre-use position to the dispensing position.

In fig. 26A is a perspective view of the lower housing member shown in FIG. 23, wherein the lower housing member includes a pair of housing latches that are configured to engage with the guides of the upper housing member to retain the upper housing member in position until use, and are also configured to engage with the needle guard to retain protective cap for the needle in the final position to prevent reuse of the device.

In fig. 26B is a front perspective view of the lower housing member shown in FIG. 26A.

In fig. 27A is a perspective view of the syringe holder shown in FIG. 23, wherein the syringe holder is configured to hold a syringe.

In fig. 27B is a perspective view of a syringe in the syringe holder shown in FIG. 27A.

In fig. 27C is a perspective view of a syringe in combination with the syringe holder shown in FIG. 27V, which is inserted into the lower element of the housing.

In fig. 28 is a perspective view of the needle guard shown in FIG. 23, wherein the needle guard includes a pair of elongated ends, each of which includes a stop that holds a corresponding housing retainer in a locking position with the guides of the upper housing member, and a needle guard retainer that is configured to engage in connection with the housing lock, after the needle guard has moved from the second position to the final position.

In fig. 29A is a partial front elevation view of the drug delivery device shown in FIG. 22A, wherein the upper housing member is in the pre-use position and the needle guard is in a first position such that the stops of the elongated ends of the needle guard abut the housing latches and hold the housing latches in a locking position with the supporting surfaces of the upper housing member guides. holding the upper housing element in position until use.

In fig. 29B is a partial front elevation view of the drug delivery device shown in FIG. 29A, for clarity, without the guides of the upper body member, where the needle guard has been moved to a second position so that the stops of the elongated ends of the needle guard no longer abut the housing latches.

In fig. 29C is a partial front elevation view of the drug delivery device shown in FIG. 29B, where the upper housing element moves to the dispensing position and the housing latches engage in the guide channels of the upper housing element.

In fig. 29D is a front elevation view of the drug delivery device shown in FIG. 29C, with the upper housing element in the dispensing position.

In fig. 29E is a partial front elevation view of the drug delivery device shown in FIG. 29D, for clarity, without the upper body guides, where the upper body is in the dispensing position and the needle guard begins to move from the second position to the end position.

In fig. 29F is a partial front elevation view of the drug delivery device shown in FIG. 29E, wherein the needle guard is in an end position and the needle guard latches are in a locking position with the housing latches, thereby locking the needle guard in the end position.

In fig. 30A is a front elevation view of the drug delivery device shown in FIG. 22A, in position before use.

In fig. 30B is a front elevation view of the drug delivery device shown in FIG. 30A, with the cap of the device removed so as to expose the needle guard.

In fig. 30C is a front elevation view of the drug delivery device shown in FIG. 30V, with needle guard in second position.

In fig. 30D is a front elevation view of the drug delivery device shown in FIG. 30C, with an upper housing element that moves to a dispensing position.

In fig. 30E is a front elevation view of the drug delivery device shown in FIG. 30D, with the top housing in the dispensing position.

In fig. 30F is a front elevation view of the drug delivery device shown in FIG. 30E, with needle guard in end position.

Detailed description of implementation examples

The following detailed description should be interpreted in light of the illustrations, in which like elements appear under the same numbers in different illustrations. The drawings, not necessarily to scale, illustrate exemplary embodiments for purposes of illustration only and are not intended to limit the scope of the invention in any way. In the detailed description, the principles of the invention are illustrated by non-limiting examples.

The present invention provides a drug delivery device and methods for its use, and the present device does not have many of the limitations and disadvantages associated with traditional syringes and needles, as well as devices such as auto-injectors. To address the limitations and disadvantages of previous devices and to meet needs in the art, embodiments of the device and methods disclosed herein include a device that is designed to prevent the user from seeing or touching the needle, thereby reducing needle phobia and the risk of potential needlestick infection . This includes automatically hiding the needle after drug delivery.

Embodiments of the device have an ergonomic form factor that allows one-handed operation of the device and alternating injection sites, such as a thigh, upper arm, or abdominal injection. In embodiments of the invention that include pressure actuation, the needle guard retainer prevents the needle from moving. Thus, the device includes a safety mechanism that will prevent the needle from being exposed without sufficient pressure on the injection site.

In fig. Ία-ID presents one embodiment of the device of the invention, which includes a window 104 allowing the drug to be viewed prior to use. After using the device, a color indicator appears in the window to visually indicate the consumption of the drug contained in the device. In addition, after delivery

- 5 043488 of the drug ensures increased safety and an extreme reduction in the risk of accidental needle sticks.

To ensure that the user is aware of the status of drug delivery and the completion of delivery, this embodiment includes safety locks and ratchet mechanisms, such as safety lock 117 and ratchet mechanism 116 in FIG. 4 and 7, which produce one or more audible clicks upon completion of the injection. This mechanism alerts the user that the drug dose has been delivered and that the device can be removed, preventing premature removal of the device from the injection site. This way, the user is actively involved throughout the entire delivery process, unlike traditional auto-injectors where the user must wait several seconds to ensure that the dose is completely delivered.

To provide better feedback to the user, the exposed safety system provides audible clicks and movement of the device during delivery, which indicates that the injection is in progress. In another embodiment of the invention, feedback indicating completion of delivery occurs only through an audible click at the end of delivery or through a combination of audible and visual indication.

Moreover, the present invention has a convenient, non-intimidating design and mode of operation, unlike traditional safety needle devices and auto-injectors that resemble syringes and cause inconvenience to the user. In addition, unlike traditional auto-injectors, the user has the ability to control the insertion of the needle and the progress of the drug injection itself, as described below.

In fig. 1-9 show an example of a device that is the subject of the present invention. In fig. Ία-ID shows an embodiment of the device at various stages of preparation for injection of a drug, and FIG. 2A-2C show an embodiment of the invention during and after drug injection. In fig. 1A shows the device 100 in a pre-use configuration, that is, as it arrives at the user's disposal. In this free position, the upper housing member 101 partially covers the proximal or uppermost portion of the lower housing member 102. In the description of various embodiments of the device, the term proximal is used to refer to the top of the device, and the term distal refers to the bottom surface of the device. For example, in FIG. 1B, distal is the bottom surface or lower portion 131 of the device 100.

As shown, externally visible elements of the device include the upper housing member 101, the lower housing member 102, the cap 103, the window 104, the lock button 105, the clamp ring 106, the lower edge 111 of the upper housing member 101, and the dose indicator 107. In FIG. Embodiment 3 of the present invention is presented in an disassembled state.

At the preparatory stage of using the device, it is necessary to remove the cap 103, which is attached to the lower element of the housing 102, as shown in Fig. 1B. Removing the cap 103 simultaneously removes the needle guard 113 and exposes the needle guard 108. The window 104 and the needle guard slot 109 (each of which is preferably present on both sides of the device) allow the user to view and control the syringe 118 located within the housing and the drug contained therein.

In practice, the palm-mounted device is grasped over the top of the housing 101, similar to the grip of a gear shift lever in a car. The clamp ring 106 provides a visual guide for the user to properly grip the device. In one embodiment of the invention, the clamp ring 106 is coated or made from a suitable elastomer, including, but not limited to, neoprene rubber, urethane, polyurethane, silicone, natural rubber, thermoplastic elastomer (TPE), or combinations thereof, to provide a non-slip and comfortable grip surface.

The user presses the device by pressing the palm down on the pressure ring 106 and the lock button 105 and pressing the device against the body at the selected injection site, typically the top or side of the upper thigh, the abdomen, or the top or back of the upper arm. Palm pressure on the lock button 105 causes it to deflect downward, as shown in FIG. 1C, which in turn releases the needle guard retainer 124 as shown in FIG. 5, allowing the needle guard 108 to slide upward and expose the needle 110 (it should be noted that some elements of the device in FIG. 5 are not shown for illustrative purposes). The needle guard retainer 124 is integrally formed with a portion of the distal end of the sleeve of the upper body member 120. The sleeve of the upper body member 120 is a hollow cylinder, part of which is located in the upper body member 101, and part of which is located in the lower body member 102, when located devices at rest. The upper housing member sleeve 120 is flexibly attached to the upper housing member 101 and functions as a locking member and also acts as a member to bias the trap 119 toward the lower housing member 102, as will be described in detail below.

The needle guard retainer 124 on the inner side with respect to the longitudinal central axis A-A' of the device includes an inclined surface 127 and a stopper 130 on its

- 6 043488 the very top end. To release the needle guard latch 124, an outwardly inclined surface 128 complementary to the surface 127 forming the distal end of the released locking button 123 engages the inclined surface 127 on the needle guard latch 124. The engagement of surfaces 127 and 128 causes the needle guard retainer 124 to yaw outward with respect to the central axis, moving the stop 130 from the position of blocking upward movement of the needle guard 108. The locking mechanism and needle guard 108 are preferably configured to prevent upward movement of the needle guard 108 unless the lock button 105 is fully depressed. This protects the needle from contamination and damage from contact with other surfaces and protects the user from accidental sticking. needle and hides the needle from view.

As the user continues to apply downward pressure to the upper housing member 101, the needle guard 108 moves upward, exposing the needle 110 and allowing it to penetrate the patient's skin, stopping when the lower surface 131 of the lower housing member 102 is firmly pressed against skin and is practically recessed into it. Once the needle guard 108 has passed the stopper 130, the user may or may not release the lock button 105 without affecting the remaining steps of the injection. When the lock button 105 is released, the elastic element 121 returns the lock button 105 to the upper position. The movement guide 132 allows the lock button to move in a straight line in an up and down direction.

The needle insertion process described herein allows the user to control the insertion. This element takes advantage of a common method often used by people with insulin-dependent diabetes: if the needle is in contact with the skin and held in this position without puncturing, then after a few seconds the user no longer feels the needle. Thus, at this point the needle can be inserted painlessly by applying pressure to it.

Once the needle 110 is inserted into the user's skin, the injection process typically begins, as shown in FIG. 2A-2C. In fig. 6, the housing latch 122, which is part of the lower housing member 102, is shown in a closed state and prevents movement of the upper housing member 101 relative to the lower housing member 102 in the device's pre-use state (it should be noted that some elements of the device in FIG. 6 are not shown in the illustrative purposes). Upon completion of the upward movement of the needle guard 108, the inclined surface 133 on the needle guard 108 contacts the inclined portion of the surface 134 forming the end of the body latch 122, causing the body latch 122 to deflect inward, thereby allowing downward movement of the upper body member 101 and the sleeve 120 the upper element of the body.

After the needle 110 is inserted into the body, the user maintains pressure on the upper housing member 101. As shown in FIG. 3, 4, 7 and 8, the piston rod 115 advances the piston 112. The piston rod 115 is fixedly connected to the upper body member 101, and the syringe 118 is securely fastened or held in a cylinder formed within the lower body member 102. Thus, as the upper member moves body member 101 downward relative to and along the lower body member 102, the drug within the syringe 110 is delivered to the patient from the needle 110 by moving the plunger rod 115 and the plunger 112 downward within the syringe 118.

Upon release of the housing latch 122, the biasing element 119 surrounding the distal end of the sleeve of the upper housing member 120 is released from the tension state by exerting a downward force on the upper housing member 101 by applying a downward force to the sleeve of the upper housing member 120, the uppermost end of which is fixed. on the upper housing member 101. The biasing element 119 may also serve to supply the energy required to advance the piston rod 115 and the piston 112, in combination with the additional necessary force applied by the user to ensure the injection of the drug, or the energy supplied by the biasing element 119 , may only be sufficient to extend the piston rod 115 and piston 112. In an alternative embodiment of the present invention, the biasing member 119 provides sufficient force to inject the drug without additional force on the part of the user: thus, an injection device is provided in which the needle is inserted manually , and the injection of the drug is performed automatically. The biasing element may be any element capable of exerting a desired degree of downward force on the sleeve of the upper housing element 120, including, but not limited to, a spring, a pneumatic actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, a shape memory alloy etc., as well as combinations thereof. In the embodiment of the invention shown in FIG. 1-9, the user applies the additional force required to extend the piston rod 115 and piston 112 by applying downward pressure on the upper housing member 101. Thus, the force required from the user to inject the medicine is reduced, similar to power steering in a vehicle, it reduces the effort required by the driver to rotate the steering wheel. Unlike traditional auto-injectors, the user is involved in creating the force required to perform the injection, and the present invention provides the user with control over the rate of injection of the drug.

In fig. 4 and 7 show cross-sectional views of embodiments of the present invention before and after drug delivery has commenced, respectively. During drug delivery, a guard 117 attached to the sleeve of the upper housing member 120 moves along a ratchet 116 attached to the lower housing member 102. The guard 117 and the ratchet 116 may perform at least two of the following functions. First, when released, they prevent the upper housing member 101 from separating from the lower housing member 102. Second, when the safety lock 117 is moved along the ratchet mechanism 116, a quiet click is heard, providing feedback to the user indicating that the upper housing member 101 is moving and drug delivery is in progress. Moreover, as shown in FIG. 8, at the end of the stroke of the upper housing member 101, the safety catch 117 may engage in a deeper recess in the ratchet mechanism 116, thereby causing a louder click that is an audible signal to the user that the stroke has ended and the delivery of the drug has been completed, and further locking the upper housing member 101 on place, preventing the device from being returned to its original position and used again.

As shown in FIG. 2B and 8, when the drug injection is completely completed and the upper body member 101 is at the end of its stroke, the lower edge 111 of the upper body member 101 covers the dose indicator 107. The dose indicator 107 is a colored ring extending along the perimeter of a circle on the distal portion of the lower member. housing 102. It serves as a visual reference to the user indicating completion of drug delivery.

Before using the device, the patient can see the drug through the window 104, which makes it possible to monitor the clarity of the solution or the presence of undissolved particles in it. After use, the piston 112 can be seen through window 104, indicating that the device has been used. Alternatively, the window design allows the plunger rod 115 to be visible after use of the device, which also indicates completion of the injection. The piston 112 and piston rod 115 may be brightly colored to provide a clear indication to the user of the use of the device.

As shown in FIG. 2C and 9, after injection, the user removes the device 100 from the skin surface, and the needle guard return member 114 causes the needle guard 108 to return to its original position and conceal the needle 110, thereby protecting the user and others from accidental needle sticks. The needle guard returner may be any element capable of causing the needle guard 108 to return to its original position and hide the needle 110, including, but not limited to, a spring, a pneumatic actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, an alloy shape memory effect, etc., as well as combinations thereof. Once the needle guard 108 is fully extended, the needle guard latch 125 engages the slot in the needle guard 108 to prevent the needle guard 108 from retracting. The needle guard retainer 125 is a sliding retainer projecting inwardly from the inner surface of the upper body member sleeve 120. The lower body protrusion 126, which is part of the lower body 102, prevents the needle guard latch 125 from prematurely engaging the slot in the needle guard 108 during delivery, blocking the slot. In another embodiment of the present invention, the needle guard 108 may protrude and lock in place when the device 100 is removed prior to completion of delivery, preventing reuse or sharing of the device.

The forced delivery method proposed by the present invention allows the user to actively participate during the entire delivery process. This method should be distinguished from the activation process of traditional auto-injectors, in which, after pressing a button, the user passively waits for several seconds for the delivery of the drug to complete, without being able to accurately determine whether the injection has been completed or not.

An additional advantage of the forced delivery method of the present invention is that it reduces the development time and costs associated with modifying and adapting the injection device for the delivery of various drugs by allowing the user to control the delivery rate by varying the force applied to the upper housing element. 101. If the plunger gets slightly stuck, the user can apply more force, unlike traditional auto-injectors which are designed based on the amount of force needed in the worst case scenario, when in reality the amount of force varies depending on the drug, cartridge, plunger, needle and frictional force arising in the mechanism.

In another embodiment of the invention, the lock button 105 and lock spring 121 may not be provided by design. In this embodiment, the upper element of the housing 101 can be freely moved downwards until it stops. This movement is used to release the needle guard 108 through a mechanism similar to the locking mechanism described above, allowing the needle guard 108 to retract. After the needle guard 108 is fully retracted, the other lock is released, which stops the downward movement of the upper body 101 and allows the drug to be injected in a manner similar to the method described above.

In fig. 10-18 show another embodiment of the invention. In fig. 10A shows a device 200 having an upper housing member 205, a lower housing member 202, and a middle housing member 201 located between them. The upper housing member 205 includes a clamp cap 228. In the free position, the upper housing member 205 partially overlaps the proximal portion of the middle housing member 201. The distalmost portion of the middle housing member 201 is fixedly secured in the lower housing member 202. Also in FIG. 10A shows the lower edge of the upper housing member 211, the travel limiting ridge 216, and the window 204. The window 204 is preferably located within the distal portion of the lower housing member 202. A second window (not shown) is preferably located on the side opposite the window 204.

The cap 203 is removably attached to the lower body member 202, and in FIG. 10B, device 200 is shown uncapped with exposed needle cover 213, needle cover clip 217, and needle guard 208. When the cap 203 is removed, the needle cap clamp 217 engages and simultaneously removes the needle cap 213, exposing the needle guard 208 and making it visible to the user. When the user of the device presses the needle guard 208 against the skin, this action causes the needle guard 208 to slide upward, exposing the needle 210, as shown in FIG. 10C.

In fig. 12 shows the device 200 in an disassembled state. The clamp cap 228 includes clamp cap assembly pins 230 that permanently secure the clamp cap 228 to the top housing member 205. The assembly pins 230 mate with holes 242 in the top housing member 205. Preferably, the assembly pins 230 have a square cross-section with rounded corners to obtain streamlined surface between the corners of the assembly pins 230 and the holes 242. The guides 233 and the piston rod 215 protrude downward from the inner surface of the clamp cap 228 and are integral with it, as shown in the figure. The piston rod 215 includes a shock absorber 221 located at its distal end. Also shown is a syringe 218 with a plunger 212 and a needle cap 213.

In a preferred embodiment of the invention, the outer surface of the clamp cap 228 is coated or made (or the entire clamp cap 228 is made) of a material that provides a soft, non-slip gripping surface for the user. Suitable materials for coating or forming the clamp cap include, but are not limited to, elastomers such as neoprene rubber, urethane, polyurethane, silicone, natural rubber, TPE, and the like. or combinations thereof.

The upper housing member 205 includes a snap latch 220, a handle guide ridge 238, and a bottom edge 211. With respect to the snap latch 220, as well as other latch elements used in the device, it is preferable to use at least two latch elements symmetrically positioned with respect to each other. to ensure smooth movement and operation of the device.

The middle housing member 201 is shown in FIG. 12, which shows its main body 207 and handle guide slots 239 on the outer surface of the proximal portion of the main body 207. During use of the device, handle guide ridges 238, integral with the upper body member 205, engage and slide within the handle guide slots 239. , providing smooth operation and controlled movement of the upper housing element 205 during drug delivery.

The main body 207 serves as a dose indicator because, upon activation of the device, the upper housing member 205 is lowered over the main body 207. Once a full dose of drug has been delivered, the main body 207 is completely hidden under the upper housing member 205, as shown in FIG. 11C. Preferably, the body 207 is colored, more preferably brightly colored or patterned, to provide visual feedback to the user indicating delivery or completion. Optionally, body 207 may include a scale visually indicating the amount of drug delivered or remaining.

As shown in FIG. 13, the middle body member 201 also includes clamp retainers 224 that retain the snap fastener slots 236, and a needle guard retainer 237. The clamp 224 is generally a rectangular member, the distalmost portion of which is movably coupled to the inner surface 243 of the middle member of the housing 201 so that, in response to force, it is capable of moving outwardly toward the inner surface 243. The clamp 224 also includes a thrust surface 245 and a triangular stop 244 protruding from the corner of its highest part inward toward the center of the device. When the device is in

- 9 043488 At rest, the clamp 224, being in the position prior to use, blocks the movement of the upper housing element 205 relative to the middle housing element 201 thanks to a stop 245, which prevents the guides 233 of the clamp cap 228 from lowering.

As shown in FIG. 12 and 13, the lower housing member 202 has a lower housing member base 206, the end of a stroke limiting ridge 216, a window 204, a housing latch 229, guide slots 227, and a syringe holding clip 235. The cap 203 is placed on the base 206 of the lower body element and is secured thereto by a retaining ring of the cap 234. In practice, the base 206 of the lower body element is in contact with the skin of the user and, therefore, should preferably be made of soft elastic materials suitable for making the clamp cap 228 .

Window 204 is formed by an opening in the lower body 202 that provides a view of the contents of syringe 218. Window 204 is positioned so that the bottom of syringe 218 is visible to the user to ensure that plunger 212 has reached the end of its stroke toward the bottom of the syringe. The window 204 can be of any convenient size and shape, preferably it is oblong in shape and its longitudinal axis is aligned with the longitudinal axis of the device and the syringe, thereby providing a view of the desired portion of the syringe.

The guide slots 227 help maintain the correct alignment of three different elements: the guides 233 of the clamp cap 228; a release mechanism 231 of the clamping clamp and an extension mechanism 241 of the protective nozzle for the needle. The guide slots 227 provide smooth activation of the device, maintaining the correct position and vertical movement of the upper housing element 202 and the protective cap 208 for the needle, as well as reliable fixation and release of the clamp 231. The outwardly projecting housing latch 229 secures the middle element of the housing 201 to the lower element housing 202 engaging a recess (not shown) in the inner surface 243 of the middle housing member 201. In non-reusable embodiments of the device, the shape of the latch 229 and the recess prevents the middle and lower housing members from being separated. In reusable embodiments of the device, the recess and retainer configuration provides for the separation of the middle and lower housing members.

As shown in FIG. 12, the needle guard 208 includes a needle guard slot 209 formed on one side by the clamp release mechanism 231 and on the other side by the needle guard extension mechanism 241. The clamp release mechanism 231 includes an inclined surface 240. As shown in FIG. 14 and 15, the inclined surface 240 of the clamp release mechanism 231 faces outward, and as the clamp 231 moves upward, it engages the inclined surface 244 on the clamp 224 facing inward, which causes the clamp 224 to deflect outward and removes the obstacle to the movement of the guides 233. and 205 down.

A slot in the needle guard 209 allows a window 204 to be used to view the syringe and plunger as the plunger is in the syringe at the end of its downward stroke. In addition, a needle guard returner 214 is located inside the lower part of the space formed by the clamp release mechanism 231 and the needle guard extension mechanism 241.

An inventive aspect of the device 200 is the method of housing the syringe 218 within the device. As shown in FIG. 12, 13, and 17, the syringe 218 is held between the needle cap 213 and the shock absorber 221, each of which is a flexible element and protects the syringe 218 in the event of fall or other mishandling of the device 200. When the device is in the assembled state, the syringe 218 is freely retained inside cavity 246 of the lower housing member 202 by means of retaining clips 235. Depending on the volume of drug inside the syringe 218, during use of the device, slight movement of the upper housing member 205 is allowed before the shock absorber 221 contacts the piston 212, and during the initial downward movement the shock absorber 221 acts as an air piston in the space between the end of the piston rod 215 and the piston 212, which provides a speed-dependent resistance to movement into the home position when the gripper moves downward. When shock absorber 221 moves quickly, air is not able to escape quickly enough to reduce the build-up of air pressure. Alternatively, shock absorber 221 may optionally include through-holes (not shown) to allow air to bleed behind shock absorber 221. Alternatively, frictional resistance of the shock absorber without pressure build-up, use of a shock absorber that is neither air bleed nor speed dependent, or their combination. When shock absorber 221 contacts piston 212, shock absorber 221 is compressed inward toward piston rod 215, reducing friction between shock absorber 221 and the inner surface of cavity 246.

As shown in FIG. 10 and 11, when using the device 200, the user removes the cap 203 from the lower housing member 202, which simultaneously removes the needle cap 213 and exposes the needle guard 208. The user grasps the device 200 by its upper housing member

- 10 043488

205, placing the palm of the hand on the clamp cap 228 and applying downward force to the clamp cap 228 while pressing the device 200 against the desired injection site on the body, the pressure force causing the needle guard 208 to slide upward, exposing the needle 210. In response In response to pressure on the clamp cap 228, the needle 210 penetrates the skin and subcutaneous tissue, stopping when the base of the lower housing member 206 contacts the surface of the skin or when the ridge 245 along the needle guard 208 reaches the end of its stroke within the lower housing member 202.

As shown in FIG. 15, when the needle guard 208 reaches the end of its stroke inside the lower body member 202, the inclined surface 240 of the clamp release mechanism 231 contacts the same-angled but oppositely directed inclined surface 244 of the clamp latch 224 of the middle body member 201, causing deflection. clamp 224 to the inner wall 243 of the middle housing member 201. As a result of this action, the abutment surface 245 of the clamp 224 no longer obstructs the downward movement of the guide 233 of the clamp cap 228, releasing the guide 233 and allowing the upper housing member 205 to move downward over the middle housing member 201.

By moving the upper housing member 205 downward, the drug contained within the syringe 218 is delivered from the needle 210 as the plunger rod 215 and the shock absorber 221 of the clamp cap 228 exert a downward force on the syringe plunger 212. At the end of drug delivery, the body 207 is substantially completely enclosed by the upper housing member 205, and the lower edge 211 of the upper housing member 205 mates with a suitably shaped limiting ridge 216 of the lower housing member 202. The piston rod 215, shock absorber 221, and piston 212 are also clearly visible within the window 204. All of these elements serve to visually confirm completion of drug delivery, and the solid stop of the lower edge 211 into the stroke limiting ridge 216 serves to provide tactile feedback to the user.

Additionally, at the end of drug delivery, a latching mechanism is activated, providing audible feedback. As shown in FIG. 14, the snap latch 220 is deflected outward as its inclined plane 247 contacts and slides against the top of the middle body member 201. When the inclined plane 247 is moved far enough in a downward direction, the inclined plane 247 is aligned with the retention slot 236 of the snap fastener, and the inclined plane 247 enters the retention slot 236, the slot extending through the wall at the proximal portion of the middle body member 201 and snapping onto the outer surface of the main body 201. part 207 of the middle member of the housing 201, producing a click. In non-reusable embodiments of the device, the snap latch 220 is permanently retained in the retaining slot 236 and cannot be returned to its original position. In a preferred embodiment of the invention, two snap latches 220 are positioned 180 degrees opposite each other to provide smooth activation of the device and facilitate latching.

When the user removes the device 200 from the skin, the returner of the needle guard 214 (the spring shown in FIG. 12), which was in a compressed state when the device 200 was pressed against the user's skin, expands, causing the needle guard 208 to extend downwards and hide 210 needles, thus protecting the user from accidental punctures. In addition to the spring, a pneumatic drive, a hydraulic drive, a wax element drive, an electrochemical drive, a shape memory alloy, etc., as well as combinations thereof, can be used as the needle guard returner. When the needle guard 208 is in the fully extended position, the needle guard stop 232 engages the stop 248 shown in FIG. 13, on the lower housing member 202, preventing the needle guard 208 from being separated from the lower housing member 202. In FIG. 16 shows a needle guard retainer 237, the distal end of which is movably connected to the inner surface 243 of the middle member of the housing 201. As the needle guard 208 moves upward, the needle guard retainer 237 is deflected outward, contacting the outer surface of the guide 233 or the elongated end. 241 needle guards. As the needle guard 208 moves downward and extends to conceal the needle 210, the needle guard retainer 237 fits onto the top of the extended end of the needle guard 241, preventing the needle guard 208 from retracting back.

Before use, the guides 233 of the elongated end of the clamp cap 228 hold the needle guard retainer 237 in an outwardly deflected position, allowing the needle guard 208 to be retracted for insertion of the needle 210. Two needle guard stops 232 and a needle guard retainer 237 are preferably used and are placed at 180 degrees around the central axis of device 200. If device 200 is removed from the skin surface before drug delivery is complete, needle guard 208 extends to conceal needle 210 and is locked in position to prevent reuse of the device. In an alternative, reusable embodiment, if the device 200 is removed from the skin surface before delivery of the drug is completed, the needle guard 208 extends but is not locked in place.

In fig. 19 illustrates an alternative, reusable embodiment of device 200 where the upper housing member 205 and the middle housing member 201 are detachable from the lower housing member 202. In this embodiment, the user detaches the middle and upper housing members, inserts a syringe 218 into the lower housing member , and then reattaches the middle and upper housing element to it.

In fig. 20 shows yet another alternative embodiment of device 200 that includes an auxiliary drive 219. The auxiliary drive 219 is most useful when delivering viscous drugs. The auxiliary actuator 219 applies a force between the upper housing member 205 and the middle housing member 201, exerting downward pressure on the adapter sleeve of the upper housing member 120. This reduces the required amount of downward pressure exerted by the user on the clamp cap 228 to inject the drug. As the auxiliary actuator 219, a spring, a pneumatic actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, a shape memory alloy, etc., and combinations thereof may be used. Alternatively, the auxiliary drive provides sufficient force to inject the drug without additional effort on the part of the user: thus, an injection device is provided in which the needle is inserted manually and the drug injection is performed automatically, similar to traditional auto-injectors.

In fig. 21 shows an alternative embodiment of the lower housing member 202 of the device 200 that includes a reusable latching mechanism for a reusable device. In this embodiment, the guide slots 227 engage with the guide 225 of the latch device 222. The latch device 222 is displaced by the return of the needle guard 214. To install the latching device 222, the user presses one of the latching device guides 225 until the latching device latch 22 engages the latching device 222, holding it in the pressed position. As the clamp cap 22 8 moves downward at the end of its stroke, the guide 233 contacts an inclined surface on the latch device retainer 226, causing it to deflect inward and release the latch device 222, allowing it to move upward in response to the force exerted by the needle guard returner 214. When the contact surface 223 of the latching device 222 contacts the lower housing member 202, an audible click is heard, signaling completion of drug delivery. The compression of the needle guard returner 214 increases when the needle guard 208 is retracted during drug injection, and the amount of force exerted on the latching device increases and the click volume increases. Alternatively, the latching mechanism automatically resets when the user attaches the upper housing member to the lower housing member after loading a new syringe into the device.

In fig. 22A-30F show yet another embodiment of a drug delivery device. As shown in FIG. 22A-22E and 23, the device 300, which is configured to deliver a drug, defines a central axis A, a proximal end P and a distal end D spaced from the proximal end D along the central axis A. As shown in FIG. 22A and 22B, device 300 may include a lower housing member 304, an upper housing member 308, and a middle housing member 312 coupled between the lower housing member 304 and the upper housing member 308.

The device 300 may further include a needle guard 316 secured to the lower housing member 304 and a device cap 320 that is removably coupled to the lower housing member 304 such that when the cap 320 is removed, the needle guard 316 is exposed. The needle guard 316 is movable relative to the lower housing member 304 along the first direction X1 from a first position in which the needle 332 of the device 300 is protected by the needle guard (i.e., as shown in FIG. 22C) to a second position in which the needle 332 is exposed (eg, as shown in FIG. 22D). When the device 300 is pressed against a tissue surface, the needle guard 316 is movable from a first position to a second position to thereby allow the needle 332 of the device 300 to be inserted into the tissue. As shown in FIG. 22C-22E and 23, the needle guard 316 includes a needle guard returner 317, illustrated as a spring 318, which is configured to cause the needle guard 316 to move from a second position to an end position along a second direction X ₂ . which is opposite to the first direction X1, and along the needle 332 as the needle 332 is withdrawn from the tissue (eg, as shown in FIG. 22E).

Also according to FIG. 22A, 22B and 23, the upper housing member 308 is secured relative to the lower housing member 304 and is configured to receive manual force and move relative to the lower housing member 304 along a second direction X2 from a pre-use position to a dispensing position in response to manual force. . As shown in FIG. 22A and 22B, the middle housing member 312 includes a body 315 that is exposed between the upper housing member 308 and the lower housing member 304 when the upper housing member 308 is in the pre-use position and is substantially completely covered by the upper housing member 308 when the upper housing member is in position. housing element 308 in the dispensing position. Therefore, the upper housing member 308 is configured to move along the middle housing body body 315 as the upper housing member 308 moves toward the dispensing position.

As shown in FIG. 22B, the upper housing member 308 may define a first or lower joining edge or surface 311, and the lower housing member 304 may define a second or upper joining edge or surface 313 that mates with the lower edge 311 of the upper housing member 308 if the upper housing member is in dispensing position. The edges 311 and 313 may have a sinusoidal shape, as shown in this example, and may provide a visual indication that the upper housing member 308 has moved to the dispensing position. It should be noted that the edges 311 and 313 can have any desired configuration. For example, edges 311 and 313 may be flat if desired.

Also according to FIG. 22C-22E and 23, delivery device 300 further includes a syringe 324 mounted on a lower housing member 304 and a piston rod 328 carried by an upper housing member 308 and movable with the upper housing member 308 so as to extend relative to the syringe. 324 if the upper housing member 308 moves along the second direction X ₂ . The syringe 324 is configured to hold medication and has a needle 332 that is configured to be inserted into tissue. The extension of the piston rod 328 relative to the syringe 324 causes the drug to flow from the needle 332 of the syringe 324 into the tissue. As shown in FIG. 22A and 22B, delivery device 300 further includes at least one window 336, such as a pair of windows 336, that provides an opening in the lower housing member 304 for visual inspection of the contents of the syringe 324. As shown in FIG. 22A, 22B and 23, the lower housing member 304 and the middle housing member 312 together form windows 336 such that the windows 336 are proximate the distal end of the device 300. Thus, the windows 336 are positioned such that the lower portion of the syringe 324 is visible to the user, whereby allowing you to ensure that the plunger rod 328 has reached the end of its stroke towards the bottom of the syringe 324. The windows 336 can be extended along the first direction X1, as shown in the drawing, it should be obvious that the windows 336 can be of any shape and size if desired .

As shown in FIG. 23, the cap 320 is removably attached to the lower housing member 304 such that when the cap 320 is removed, the needle guard 316 is exposed and the needle cap 338 is detached from the syringe 324, thereby exposing the needle 332 within the needle guard 316. As shown in FIG. 23, the cap 320 includes a cap body 340 and a needle cap clip 344 attached to the cap body 340. The cap body 340 defines a cavity 348 that includes a needle guard 316 when the cap 320 is attached to the lower body member 304, and a cap retaining ring 352 that engages the lower body member 304 to thereby removably connect the cap 320 to the lower member. housing 304. As shown in FIG. 23, the cap retaining ring 352 defines a pair of detents 356 that are configured to engage a pair of projections 350 located in the lower housing member 304 to thereby removably connect the cap 320 to the lower housing member 304. To remove the cap 320, the lower housing member 304 may form a pair of ridges on either side of the projections 350 that would allow the cap to be unscrewed. For example, the ridges may engage curved surfaces on the cap such that when the cap is rotated, the ridges separate the cap from the lower body member 304. However, it should be understood that the cap retaining ring 352 may optionally include any elements that removably connect the cap 320 with lower housing element 304.

Also according to FIG. 22C and 23, the needle cap clamp 344 may be coupled to the cap body 340 within the cavity 348. The needle cap clamp 344 is configured to engage the needle cap 338 when the cap 320 is connected to the lower housing member 304. The needle cap 338 is attached to the syringe 324 such that that the needle cap 338 covers the needle 332. When the cap 320 is removed from the lower body member 304, the needle cap clamp 344 engages the needle cap 338 such that the needle cap 338 is removed from the lower body member 304 along the cap 320. When the cap 320 is removed, the device 300 can be pressed against tissue surface and then activated to deliver the drug into the tissue.

As shown in FIG. 23, 24A-24C, the upper body member 308 may include a skirt 360, a body body 364 mounted on the skirt 360, and a clamp cap 368 mounted on the body body 364. As shown in FIG. 24A and 24B, the upper housing member 308 and, in particular, the main body 364 includes a clamping cap mounting member 372 and a pair of guides 376 that extend distally from the clamping cap mounting member 372

- 13 043488 along the second direction X2. As shown in FIG. 23, the clamp cap 368 may be coupled to the clamp cap mounting member 372, and the guides 376 may extend through the skirt.

360 if the main body 364 is mounted on the skirt 360.

The clamp cap mounting member 372 may be domed shaped to define a substantially convex proximal surface 374 and a distal surface 375 that is opposed to the proximal surface 374. The clamp cap 368 may also be domed shaped and may be mounted on the clamp cap mounting member 372 so that the clamp cap 368 lay over the proximal surface 374. As shown in FIG. 24A, the mounting member 372 may include a plurality of locking members 380 that extend from the distal surface 375. The locking members 380 may in each case define an opening 381 that is configured to receive a corresponding locking member, such as a mounting pin 382, formed in the skirt 360 , thereby connecting the main body 364 to the skirt 360. However, it should be noted that the locking elements 380 and 382 can be of any desired configuration. For example, the locking members 380 of the mounting member 372 may define the mounting pins, and the locking members 382 of the skirt 360 may define the holes. It should also be understood that the clamp cap 368 and the main body 364 can be integrally formed if desired, and that the clamp cap 368 and the mounting member 372 can be of any desired shape.

As shown in FIG. 24A, the upper housing member 308 may further include at least one locking latch 390, such as a pair of locking latch 390, that extends from a distal surface 375 of the mounting member 372 and to the lower housing member 304. The locking latch 390 is configured to lock the upper member. of the housing 308 in the dispensing position after the upper member of the housing 308 has moved from the pre-use position to the dispensing position so as to prevent reuse of the device 300. The locking latches 390 may be elastically flexible and in each case may include a flexible member 392 that extends from the mounting member 372, and a projection 394 that extends from the distal end of the flexible member 392 to the central axis A. As shown in FIG. 22C-22E, the locking latches 390 face each other so that the projections 394 extend towards each other along a direction that is perpendicular to the second direction X ₂ . As shown in FIG. 22C-22E, as the upper housing member 308 moves along the middle housing member 312, the locking tabs 390 will engage the lower housing member 304 and bend in opposite directions from each other. If the upper housing member 308 reaches the dispensing position, the locking latches 390 will move back toward each other such that the projections 394 engage the corresponding locking member of the lower housing member 304, thereby locking the upper housing member 308 in the dispensing position. When the locking latch 390 engages the corresponding latch members, an audible click can be heard, thereby notifying the user that the injection has been completed. However, it should be understood that the locking tabs 390 can be of any configuration if desired, and that the upper housing member 308 can optionally include any number of locking tabs. For example, the upper housing member 308 may optionally include a single locking latch.

As shown in FIG. 22C, 23, and 24A-24B, each guide 376 of the body body 364 extends through the skirt 360 into the middle body member 312. Each guide 376 may include a guide body 377 that extends along a second direction X2 and extends from the mounting member 372, so that the guides 376 face each other along a direction that is perpendicular to the second direction X ₂ . The guides 376 are configured to be temporarily coupled to the lower housing member 304 to secure the upper housing member 308 in a pre-use position until the needle guard 316 is moved to a second position and the needle 332 is inserted into the fabric. This will prevent accidental dispensing of the drug.

As shown in FIG. 24B, each guide 376 may define a support surface 398 that at least partially faces the lower housing member 304, and a channel 400 that extends through the main portion of the guide 377 from a distal end of the main portion of the guide 377 and to a proximal end of the main portion of the guide 377. The support surfaces 398 are configured to engage the lower housing member 304 if the upper housing member 308 is in the pre-use position, thereby holding the upper housing member 308 in the pre-use position until the needle guard 316 has moved. to the second position. The support surfaces 398 may be located proximate the distal ends of the guide members 377. The support surfaces 398 may define a plane that is perpendicular to the first direction and may include an inclined portion defining a slope leading into a corresponding channel 400. The channels 400 extend through the guide members 377 along the direction which is perpendicular to the second X ₂ direction and extends along a significant portion of the guide members 377 along the second X ₂ direction. The channels 400 are configured to release or guide the lower housing member 304 when the connection between the upper housing member 308 and the lower housing member 304 is removed and the upper housing member 308 is moved to a dispensing position. That is, the portion of the lower housing member 304 that is overlapped by the upper housing member 308 will move within the channels 400 after the connection is removed and the upper housing member 308 is moved to the dispensing position. However, it should be noted that the support surfaces 398 and channels 400 can have any desired configuration. For example, the support surfaces 398 may be inclined if desired, and the channels 400 may extend into, but not through, the guide members 377.

As shown in FIG. 24C, skirt 360 includes a skirt body 404 that defines an inner surface 408 defining a channel 412 that extends completely through the skirt body 404 along a second direction X ₂ . The upper housing member 308 is coupled to the middle housing member 312 such that the middle housing member 312 fits within the channel 412, and the middle housing member 312 is movable along the channel 412 as the upper housing member 308 moves toward the dispensing position. As shown in FIG. 24C, the skirt 360 includes at least one friction element 416, such as four friction elements 416 that extend from the inner surface 408 to the central axis A. The friction elements 416 are configured to connect with corresponding friction elements formed by the middle body element 312 , thereby generating frictional force as the upper housing member 308 moves from the pre-use position to the dispensing position. The frictional force increases the resistance if manual force is applied to the upper housing member 308, thereby preventing the upper housing member 308 from accidentally moving along the second direction X2. For example, the frictional force may prevent accidental movement of the upper housing member 308 in situations where the syringe 324 is only partially filled with drug and the plunger rod 328 is not in contact with the piston that is placed within the syringe 324. The frictional force generated by the friction members should be greater than or be equal to the force of the compressed spring of the needle guard 318 when the needle guard 316 is in the second position, thereby preventing the lower body member 304 from being lifted by the action of the needle guard spring 318 and leaving the needle 332 from the fabric before the plunger rod 328 is inserted into contact with the piston. However, it should be noted that the friction force can have any desired value. For example, the skirt 360 and the midbody member 312 may have no friction elements such that the friction force is essentially zero. It should be further noted that the skirt 360 may optionally define any number of friction elements 416.

Also according to FIG. 24C, each friction element 416 may define a rack 420 that extends from the inner surface 408. As shown in FIG. 24C, each rack 420 may gradually taper as the rack 420 moves from the distal end of the skirt 360 to the proximal end of the skirt 360. Therefore, the frictional force may be greater when the upper housing member 308 begins to move from the pre-use position than the frictional force if the upper housing member 308 is located near the dispensing position. However, it should be noted that the slats 420 can have any desired configuration. For example, the racks 420 may not have a taper such that the frictional force between the upper housing member 308 and the middle housing member 312 is constant throughout the entire movement of the upper housing member 308.

As shown in FIG. 25A and 25B, the middle body member body 315 includes a side wall 464 and at least one friction element 468, such as four friction elements 468 carried by the side wall 464. Each friction element 468 is configured to be coupled to a corresponding one of the friction elements 416 of the upper housing member 308. As shown in FIG. 25A, each friction member 468 may be configured as a cantilever portion 472 that connects to a side wall 464 at a hinge 474 such that each cantilever portion 472 is configured to flex about a central axis of the middle housing member 312 (e.g., a central axis A) as required. moving the upper housing member 308 to the dispensing position. As shown in FIG. 25A, the side wall 464 is substantially cylindrical and includes four slots 478, each of which defines a corresponding cantilever portion 472. Each slot 478 extends from the proximal end of the main body body portion 315 and terminates at a corresponding hinge 474. In the illustrated embodiment, the hinges 474 are directed such that the cantilever portions 472 bend about their respective axes that are parallel to the central axis A. As shown in FIG. 25A, the console portions 472 form a first and second pair of console portions, each including a first console portion 472a and a second console portion 472b. The first and second cantilever portions 472a and 472b of each pair are directed oppositely from each other. That is, the first cantilever portions 472a of the first and second pairs extend clockwise around the side wall 464, and the second cantilever portions 472b of the first and second pairs extend counterclockwise around the side wall 464. Therefore, each cantilever portion 472 may have a curvature so as to define a radius relative to the central axis A. However, it should be obvious that the cantilever parts 472, if desired, can have any configuration and hinges 474 at

- 15 043488 can have any configuration if desired. It should be further noted that the friction elements 468 are not limited to the cantilever portions 472 and may include any configuration if desired. For example, the friction elements 468 may be elastomeric pads on the outer surface of the side wall 464.

Also according to FIG. 25A-25B, each cantilever portion 472 may be located near the proximal end of the middle housing member 312. Each cantilever portion 472 may include an outer elastomeric portion 480 that is configured to contact a corresponding rack 420. The elastomeric portions 480 may be used to increase the coefficient of friction. surfaces of the cantilever portions 472 that contact the slats 420, thereby adjusting the resistance. As shown in FIG. 25C, initially, when the upper housing member 308 begins to move from the pre-use position, the thicker portion of the slats 420 is in contact with the elastomeric portions 480 such that the cantilever portions 472 bend inward toward the central axis A and exert a biasing force on the slats 420. The connection between slats 420 and cantilever portions 472 creates a frictional force that prevents the upper housing member 308 from moving toward the dispensing position. As the upper housing member 308 moves further toward the dispensing position, the slats 420 narrow so that the biasing force on the slats 420 is reduced and the resistance to downward movement of the upper housing member 308 is reduced.

As shown in FIG. 26A and 26B, the lower housing member 304 includes a base 490 and a lower housing member body 494 that extends from the base 490 along the first direction X1. The base 490 includes a skin-facing surface 498 that is configured to contact the patient's skin when the needle 332 is inserted into the tissue. The base 490 further defines a cavity 502 that extends to the skin-facing surface 498 and is configured to receive the needle guard 316 as the needle guard 316 moves to the second position. The lower body body 494 defines a pair of first channels 506a that extend along the lower body body 494 along the first direction X1, and a pair of second channels 506b that extend along the lower body body 4 94 along the first direction Xi adjacent the first channels. 506a. Each channel 506a is sized to receive corresponding guides 376 of the upper housing member 308 such that the guides 376 extend into the first channels 506a along the second direction X ₂ as the upper housing member 308 moves toward the dispensing position. The second channels 506b are configured to receive a portion of the needle guard 316 such that the portions of the needle guard 316 are disposed between the lower body member body 494 and the guides 376 and are configured within the channels 506b along the first and second directions X1 and _X2 .

As shown in FIG. 26A and 26B, the upper housing member 304 further includes at least one housing latch 510, such as a pair of housing latch 510, that is configured to lock the upper housing member 308 and then be removable when the upper housing member 308 is in the pre-use position so to prevent the upper housing member 308 from moving toward the dispensing position. As shown in FIG. 26B, each body retainer 510 includes a leg 512 that extends upward from a corresponding portion of the lower body body body 494, and a projection 514 that extends from a proximal end of the leg 512 from the central axis A and into the channels 400 defined by the guides 376.

The housing latches 510 are elastically flexible such that the housing latches 510 are configured to flex or otherwise move out of connection with the upper housing member 308 as the upper housing member 308 is moved from a pre-use position to a dispensing position. In particular, the projections 514 engage the supporting surfaces 398 of the guides 376, thereby preventing the upper housing member 308 from moving toward the dispensing position. If the needle guard 316 has moved to the second position and the housing latches 510 are free to flex, movement of the upper housing member 308 to the dispensing position causes the projections to move into and along the channels 400 of the guides 376, and thereby move out of connection with the upper housing member 308 It should be understood that the housing latches 510 may be of any configuration if desired and may extend from any portion of the lower housing body body 494. For example, each leg 512 may extend downward from a corresponding portion of the lower housing body body 494.

Also according to FIG. 26A and 26B, the lower housing member 304 further includes at least one latch member 530, such as a pair of latch members 530 that are configured to engage with the locking latches 390 of the upper housing member 308 when the upper housing member 308 is in the dispensing position. . As shown in FIG. 26A, each latch element 530 may define a bevel 532 that extends from the lower body member body 494 and a step 534 at the distal end of the bevel 532. The step 534 defines a surface that faces the distal end of the device. As the upper housing member 308 moves toward the dispensing position, the projections 394 of the locking tabs 390 will extend along the bevels 532 and bend in opposite directions from each other. If the upper housing element 308 reaches

- 16 043488 to the dispensing position, the locking latches 390 will snap over the retaining elements 530 and substantially return to their original position such that the projections 394 engage the steps 534, thereby locking the upper housing member 308 in the dispensing position. In particular, the projections 394 engage the supporting surfaces of the steps 534 to thereby prevent the upper housing member 308 from returning to its pre-use position. However, it should be noted that the elements of the clamps 530 can have any desired configuration. For example, the latch elements 530 may be slots formed in the lower housing member body 494 that receive the projections 394.

The contact between the projections 394 of the locking tabs 390 and the bevels 532 may create a frictional force that increases the resistance of the downward manual force applied to the upper housing member 308 to move the upper housing member 308 to the dispensing position. Therefore, the locking latch 390 and latch elements 530 can also be considered friction elements. That is, the racks 420 and cantilevers 472 may be classified as primary friction elements, and the locking detents 390 and detent elements 530 may be classified as secondary friction elements.

As shown in FIG. 23 and 27A-27C, the syringe 324 may include a lower bead 540 that is located proximate the needle 332 and an upper bead 544 spaced from the lower bead 540 along a first direction X _b As shown in FIG. 27A-27C, device 300 may further include a syringe holding clip 548 that is configured to receive a syringe 324 and retain the syringe 324 in the region of the lower collar 540. The syringe holding clip 548 may include a body 552 and a pair of elastic flexible legs 556 that extend from the main body along the second direction X ₂ . The elastically flexible legs 556 are spaced apart along a direction perpendicular to the second direction X ₂ so as to define a gap 560 between the elastically flexible legs 556. Each elastically flexible leg 556 includes a tongue 564 that extends to the other leg 556 such that as the syringe 324 moves through the lumen 560 along the second direction and toward the fixed position, the elastically flexible legs 556 move away from each other, and when the syringe 324 is in the fixed position, the elastically flexible legs 556 again move back towards each other so that the tab 564 engages the lower stop 540 of the syringe 324. Once the syringe holder and holder elements are inserted into the lower housing member 304, the position of the flexible legs 556 is fixed and thereafter cannot bend outward, thereby securing the syringe 324. In the illustrated embodiment, the tabs 564 are located at the distal ends of the legs 556. However, it should be noted that the guides 564 can be positioned anywhere along the legs 556 if desired.

Also according to FIG. 27A, the syringe holder 548 further includes an opening 572 that extends through the body 552 and into the gap 560, and at least one clip 576 carried by the body 552 within the opening 572. At least one clip 576 is configured to abut the syringe. 324 to prevent the syringe 324 from moving through the gap 560 along the first direction X _b after the syringe 324 is in a fixed position. The clamps 576 may be elastomeric portions, ribs, or any other structure capable of preventing the syringe 324 from exiting the gap.

As shown in FIG. 27A and 22C, the syringe holder 548 further includes at least one locking tab 580, such as a pair of locking tabs 580 that extend from the main body 552 from the central axis A. The locking tabs 580 are configured to abut the lower housing member 304. to thereby lock the syringe holding clip 548 within the lower housing member 304. The locking tabs 580 may be flexible such that, after the syringe holder 548 is locked into the lower housing member 304, the locking tabs 580 are folded toward the central axis A and then move back to their original position after the syringe holder 548 is fully secured within the lower body member 304 such that the locking tabs 580 engage with corresponding portions of the lower body member 304 to thereby lock the syringe holder 548 and the syringe 324 within the lower member housing 304. However, it should be noted that the syringe holder 548 can have any desired configuration. For example, locking tabs 580 may optionally extend from legs 556.

As shown in FIG. 23, 22C-22E and 28, the needle guard 316 is configured relative to the lower body member 304 along the first direction X ₁ from a first position to a second position when the needle guard 316 is pressed against the skin surface, and is subsequently movable along the second direction X2 from the second position to the final position after the device 300 is removed from the skin surface. As shown in FIG. 28, the needle guard 316 includes a base 600 and a pair of elongated ends 604 that extend from the body 600 along a first direction X ₁ . Housing 600 houses needle 332 when needle guard 316 is in the first position and end positions. As the needle guard 316 moves to the second position, the needle 332 exits the housing 600 and enters the fabric.

As shown in FIG. 23 and 28, the projections 604 are opposed to each other and are movable within the corresponding second channel 506b of the lower housing member 304, so

- 17 043488 that the elongated ends 604 are in each case located between the lower housing member body 494 and the corresponding guide 376 of the upper housing member 308. As shown in FIG. 28, each protrusion 604 defines a stop 612 that is configured to engage or otherwise abut a corresponding housing latch 510, such as a protrusion 514 of the body latch 510 when the needle guard 316 is in a first position so as to retain the latch 510 the housing in a locked position with the upper housing member 308. As the needle guard 316 moves to the second position, the stopper 612 moves out of contact with the housing latches 510. The housing latches 510 may then be retractable from the connection with the upper housing member 308 such that the upper housing member 308 is movable to a dispensing position. Therefore, the upper body member 308 can be held in position until use until the needle guard 36 has moved to the second position.

Also according to FIG. 28, the needle guard 316 further defines an opening 616 in each projection 604 and a needle guard retainer 620 that extends upward from the projection 604 and into the opening 616. Each needle guard retainer 620 is resiliently flexible and defines a groove 624 at its proximal end. and a hinge 628 at the distal end. The needle guard latches 620 are configured to flex about their hinges 628 as the needle guard 316 moves from a second position to a final position and if the upper housing member 308 is in a dispensing position. As shown in FIG. 28, each needle guard retainer 620 defines a side wall 632 that extends from the hinge 628 to the channel 624. At least a portion of the side wall 632 is located adjacent to the channel 624 and extends at an angle relative to the first or second direction. The projections 514 of the housing detents 510 may extend along the inclined portions of the side wall 632 as the upper housing member 308 moves toward the dispensing position, causing the needle guard retainer 620 to flex, and as the needle guard 316 moves from the second position to the final position. If the device 300 is then removed from the fabric and the needle guard 316 is moved to its final position, the needle guard latches 620 will fold back to their original positions such that the grooves 624 receive the projections 514 of the body latches 510, thereby locking the guard 316 for needle in final position.

As shown in FIG. 29A-29F, the housing latches 510 may be configured to selectively hold the upper housing member 308 in position prior to use and then hold the needle guard 316 in its final position. As shown in FIG. 29A, if the upper housing member 308 is in the pre-use position and the needle guard 316 is in the first position, the projections 514 of the housing detents 510 abut the corresponding support surfaces 398 of the guides 376 of the upper housing member 308, preventing the upper housing member 308 from moving to the position. issuance. As shown in FIG. 29A, the stops 612 of the needle guard 316 abut the projections 514 and lock the projections 514 into a locking position with the support surfaces 398. As shown in FIG. 29B, when the needle guard 316 is moved to the second position, the stops 612 are retracted from the projections 514 such that the housing latches 510 are movable from the support surfaces 398 of the upper housing member 308 and the upper housing member 308 is movable to a dispensing position. As shown in FIG. 29C and 29D, as the upper housing member 308 moves toward the dispensing position, the projections 514 engage and move along the channels 400 of the guides 376. As shown in FIG. 29D, the projections 514 extend along the beveled portions of the side wall 632 and cause the needle guard retainers 620 to flex so that the projections 514 can continue to move along the channels 400. As shown in FIG. 29E and 29F, as the needle guard 316 moves from the second position to the end position, the projections 514 extend along the side walls 632 until the needle guard latches 620 fold back to their original position and the grooves 624 receive the projections 514, whereby locking the needle guard 316 in its final position. Thus, the housing latches 510 may be configured to hold the upper housing member 308 in position prior to use and lock the needle guard 316 in its final position.

In working order and as shown in Fig. 30A-30F, delivery device 300 may be configured to deliver a drug. Before use, the upper housing member 308 may be locked in position prior to use by housing latches 510, and the cap 320 may be coupled to the lower housing member 304 so as to cover the needle guard 316 and the needle 332. When the device 300 is ready for use, the cap 320 can be removed from the upper housing member 304 such that the cap 320 simultaneously removes the needle cap 338 from the needle 332, as shown in FIG. 30V.

As shown in FIG. 30C, the device 300 may be positioned at the surface of the skin and a manual force may be applied to the upper housing member 308 along the direction of insertion (e.g., the second direction) such that if the needle guard 316 is pressed against the skin surface, the needle guard 316 moves toward the second position and the needle 332 is inserted into the tissue. As

- 18 043488 By moving the needle guard 316 to the second position, the stopper 612 is disengaged from the housing latches 510 so that the upper housing member 308 is no longer locked in the pre-use position. As shown in FIG. 30D and 30E, the upper housing member 308 can then move along the second direction and over the middle housing member 312. When the upper housing member 308 reaches the dispensing position, substantially the entire middle housing member 312 is covered by the upper housing member 308 and the piston can be seen inside the windows 336 , whereby providing visual confirmation that all of the drug has been introduced into the tissue.

Moreover, if the upper housing member 308 reaches the dispensing position, the locking latches 390 of the upper housing member 308 engage the locking members 530 of the lower housing member 304, thereby locking the upper housing member 308 in the dispensing position, preventing reuse of the delivery device 300 Once the locking latches 390 snap over the latch members 530, an audible click is heard which serves as an indication to the user that the upper housing member 308 has reached the dispensing position and is locked in the dispensing position. The upper housing member 308 may be permanently locked in the dispensing position such that the device 300 cannot be reused. However, it should be noted that the upper housing member 308 can be temporarily locked so that the device 300 can be sterilized and reused.

As shown in FIG. 30F, if the device 300 is retracted from the skin surface along a direction opposite to the insertion direction, the needle guard 316 moves along the second direction to a final position. Having reached the final position, the housing latches 510 are connected by the needle guard latches 620, thereby locking the needle guard 316 in the final position. Thus, the needle guard 316 may be irreversibly locked in its final position so that the device 30 cannot be used repeatedly. However, it should be appreciated that the needle guard 316 can be temporarily locked so that the device 300 can be sterilized and reused.

As shown in FIG. 30B and 30F, the needle guard 316 may be movable a first distance d1 along a first direction from a first position to a second position and a second distance _d2 along a second direction from a second position to an end position. The second distance d ₂ may be greater than the first distance d1, thereby providing an indication to the user that the needle guard 316 is indeed in its final position and locked. The needle guard 316 and, in particular, the needle guard 316 body 600 may include a visual indicator 640, such as a colored stripe at the proximal end of the needle guard 316, that is visible only when the needle guard 316 is in its final position. However, it should be apparent that the needle guard 316 can be moved any distance from the first position to the second position and any distance from the second position to the end position.

Although the foregoing description and drawings represent the preferred embodiment of the present invention, it should be understood that various additions, modifications, combinations and/or substitutions may be made to the described structure without departing from the spirit and scope of the present invention, as defined below in the claims. inventions. In particular, it will be appreciated by those skilled in the art that the present invention may be implemented in other specific forms, structures, geometries, proportions, and other components, materials and components without affecting the essence and important characteristics of the present invention. One skilled in the art will understand that the present invention can be used with numerous modifications in structure, geometry, proportions, materials, components, specifically adapted for use in specific operating conditions and in accordance with performance requirements without departing from the principles of the present invention. In addition, the elements described herein may be used alone or in combination with other elements. For example, elements described in connection with one component may be used and/or interchanged with elements described in connection with another component. Thus, the embodiment described herein is considered to be exemplary and is not intended to limit in any way the scope of the present invention as defined by the appended claims and the foregoing description.

It will be apparent to those skilled in the art that the present invention is subject to various modifications and changes without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be obvious to those skilled in the art. They include a multiple dose configuration in which the upper or middle housing elements, or both housing elements together, are not fully utilized and when pressed by the user, a partial delivery of the dose contained in the syringe is achieved.

-

Claims (33)

CLAIM 1. A method of administering a drug from a drug delivery device of a type that includes an upper housing member, a lower housing member, a syringe supported by the lower housing member and containing a needle, and a needle guard supported by the lower housing member, the method comprising the steps of: positioning the drug delivery device against the surface of the skin so as to provide abutment of the needle guard against the surface of the skin, the upper housing member being releasably locked relative to movement in the direction of the needle by a housing lock that locks the upper housing member; applying a force to the upper body member along the direction of insertion, whereby the skin surface causes the needle guard to be retracted relative to the lower body member and thereby exposes the needle for insertion into the skin surface; at the application stage, the forces cause the housing latch to move out of locking with the upper housing element; continuing to apply a force to the upper body along the direction of insertion, thereby causing the upper body to move towards the needle and thereby pushing the drug contained inside the syringe out of the needle; moving the drug delivery device away from the skin surface along a direction opposite to the direction of insertion to remove the needle from the skin surface and to extend the needle guard relative to the needle to a final position, whereby the needle guard substantially encloses the needle; and ensuring that the needle guard is locked in its final position by the housing lock. 2. The method of claim 1, wherein the continuing step further comprises the step of actuating a plunger rod in the syringe to deliver the drug from the needle. 3. The method of claim 1, which, after the continuation step, further comprises the step of preventing the upper body member from being pulled back from the needle. 4. The method of claim 1, wherein the drug delivery device further includes a middle housing member coupled between the upper housing member and the lower housing member, wherein the continuation step comprises the step of the upper housing member gradually covering the main portion of the middle member housing, thereby providing a visual indication that the drug has been delivered. 5. The method of claim 4, wherein the continuing step comprises causing the friction member of the upper housing member to rub against the friction member of the middle housing member as the upper housing member gradually covers the main portion, thereby creating a frictional force between the upper housing member and the upper housing member. body element and middle body element. 6. The method of claim 5, wherein the friction element of the middle body member is configured as a cantilever portion, the further step of which is to cause the cantilever portion to bend relative to the central axis of the middle body member as the upper body member moves toward the dispensing position. 7. The method of claim 6, wherein the friction element of the upper body member is a rack, and the continuation step involves allowing the rack to pass along the cantilever portion. 8. The method of claim 5, wherein during the movement step, the spring causes the needle guard to move from the second position to the end position and over the needle after the needle is removed from the fabric, wherein the friction force between the friction elements of the upper and middle body elements is greater than or equal to the force generated by the spring when the needle guard is in the second position. 9. The method of claim 1, wherein the needle guard has a stop that is configured to abut the housing lock when the needle guard is in the first position so as to hold the housing lock in the locking position of the upper housing element; and the application step includes causing the stopper to be released from contact with the housing latch as the needle guard moves from the first position to the second position and causing the housing latch to move out of interlock with the upper housing member. 10. The method of claim 1, wherein the application step comprises causing the needle guard to move a first distance along a direction opposite to the insertion direction when the needle guard moves from the first position to the second position so as to expose the needle, and the moving step includes causing moving the needle guard a second distance along the insertion direction as the needle guard moves to a final position, the second distance being greater than the first distance. 11. The method of claim 1, wherein the step of providing interaction of the needle guard lock with the housing lock when the needle guard is moved to an end position, thereby locking the needle guard in the end position. - 20 043488 12. The method of claim 11, wherein the needle guard retainer includes a groove and the body retainer includes a projection, and the moving step includes causing at least one of the needle guard retainer and the body retainer to bend toward the other , so that the protrusion is received into the groove when the needle guard is in its final position. 13. The method of claim 11, wherein the lower housing member includes a housing retainer and another housing retainer, and the needle guard includes a guard retainer and another guard retainer, wherein the moving step includes ensuring that each needle guard retainer mates with and another needle guard clamp with a housing clamp and another housing clamp, respectively, when the needle guard is moved to an end position. 14. The method of claim 1, wherein the lower housing member includes a housing latch and another housing latch, and the upper housing member includes a pair of guides, and at the placement stage, each of the guides abuts a corresponding one of the housing latch and the other latch the housing when the upper housing member is in the pre-use position, thereby holding the upper housing member in the pre-use position. 15. The method of claim 1, wherein the continuation step comprises moving the housing lock protrusion into the housing upper member guide channel when the housing upper member is moved from the pre-use position towards the dispensing position. 16. The method of claim 15, wherein the guide defines a support surface that leads into the channel, and wherein the housing lock locks the support surface when the upper housing member is in the pre-use position. 17. The method of claim 1, comprising the step of inserting a syringe into a syringe holder of a drug delivery device such that the syringe holder supports the syringe in a lower collar of the syringe. 18. The method of claim 17, wherein the injection step comprises causing the syringe to move through the gap between a pair of elastically flexible legs of the syringe holder in the direction of the fixed position, such that the syringe causes the elastically flexible legs to move away from each other, and when the syringe is in the fixed position, the elastically flexible legs move rearwardly towards each other so that the tongues of the elastically flexible legs engage the lower collar of the syringe. 19. The method of claim 17, wherein the method includes the step of inserting a syringe holder with a syringe into the lower housing member such that at least one tab of the syringe holder abuts the lower housing member to thereby lock the syringe holder within the lower housing member. 20. The method of claim 1, wherein the upper housing element includes at least one locking latch, the lower housing element defines at least one corresponding latch element, and the further step includes causing the at least one locking latch to snap into place on the at least one at least on one locking element so as to lock the upper housing element in the dispensing position. 21. A device (300) configured to administer a medicinal product, comprising a lower housing element (304) that includes a housing latch (510); a syringe (324) supported by a lower housing member (304) and configured to hold a medicament, the syringe (324) having a needle (332) configured to be inserted into tissue; a needle guard (316) that is movable relative to the lower body member (304) along a first direction from a first position to a second position so as to expose the needle (332), and then from the second position to a final position to enclose the needle (332) into oneself; an upper housing member (308) supported relative to a lower housing member (304), wherein the upper housing member (308) is configured to receive manual force and move relative to the lower housing member (304) along a second direction opposite to the first direction from a pre-use position to the dispensing position in response to manual force; and a piston rod (328) carried by the upper housing member (308) and movable with the upper housing member (308) so as to extend relative to the syringe (324) when the upper housing member (308) is moved along the second direction, the rod extending piston (328) relative to the syringe (324) causes the syringe (324) to dispense medication from the needle (332), characterized in that the housing latch (510) releasably locks the upper housing element (308) when the upper housing element is in the position prior to use so as to prevent movement of the upper housing member (308) in the direction of the dispensing position, and movement of the needle guard (316) in the direction of the second position causes the lock to be released while allowing movement of the upper housing member (308) from the pre-use position to dispensing position; And - 21 043488 needle guard (316) includes a needle guard retainer (620), wherein the needle guard retainer (620) is operative with the housing retainer (510) when the needle guard (316) moves to the end position so that the body lock (510) locks the needle guard (316) in the end position. 22. The device according to claim 21, in which the needle guard (620) includes a groove (624) and the housing lock (510) includes a projection (514), and at least one of the needle guard lock (620) and the housing lock (510) is configured in the other direction so that the protrusion (514) is received into the groove (624) when the needle guard (316) is in its final position. 23. The apparatus of claim 21 or 22, wherein the needle guard (316) further includes a housing (600) and a pair of projections (604) extending from the housing (600) along the first direction, wherein the needle guard (316) further defines holes (616) in each projection (604), and a needle guard retainer (620) extends upward from each projection (604) and into the hole (616); the needle guard retainer (620) is resiliently flexible and forms a hinge (628) at its distal end and the needle guard retainer (620) is configured to flex around the hinge (628) when the needle guard (316) is moved from second position to the end position. 24. The device according to any one of claims 21-23, in which the groove (624) is located at the proximal end of the clamp (620) of the needle guard; and the groove (624) receives the body lock projection (514) to thereby lock the needle guard (316) in the final position. 25. The device of claim 24, wherein the needle guard retainer (620) forms a side wall (632) that extends from the hinge (628) to the groove (624); at least a portion of the side wall (632) that is located adjacent to the groove (624) is angled relative to the first or second directions, and the protrusion (514) of the housing latches (510) is movable along the angled portions of the side wall when the upper the housing member (308) moves toward the dispensing position so as to cause the needle guard latches (620) to flex as the needle guard (316) moves from the second position to the end position. 26. The device according to any one of claims 21 to 25, wherein the needle guard (316) carries a stopper (612) which abuts against the housing latch (510) when the needle guard (316) is in the first position, so to support the housing retainer (510) in engagement with the upper housing member (308). 27. The device according to claim 26, wherein when the needle guard (316) is moved in the direction of the second position, the stopper (612) moves out of contact with the body latch (510), so that the body latch (510) is movable from interaction with the upper housing element (308). 28. The apparatus of claim 27, wherein the needle guard (316) includes a needle guard returner (317) configured to cause the needle guard (316) to move toward an end position along the second direction, and over the needle (332) when the needle (332) is removed from the fabric. 29. The apparatus of claim 28, wherein the needle guard (316) is configured to move a first distance along the first direction when the needle guard (316) moves to the second position, and the needle guard (316) is configured movable a second distance along a second direction as the needle guard (316) moves to an end position, the second distance being greater than the first distance. 30. The device according to any one of claims 21 to 29, wherein the lower housing member (304) includes two housing latches (510) and the needle guard (316) includes two needle guard latches (620). wherein each needle guard latch (620) is configured to interact with a corresponding one of the housing latch (510) when the needle guard (316) is moved to a final position. 31. The apparatus of claim 30, wherein the upper housing member (308) includes a pair of guides (376), each of which abuts a corresponding housing latch (510) when the upper housing member (308) is in the pre-use position so as to properly hold the upper housing member (308) in position until use. 32. The apparatus of claim 31, wherein each guide (376) includes a main body and a channel (400) that extends through the body along the first direction, and each housing latch (510) includes a projection (514) that is configured to movement into a corresponding one of the channels (400) when the upper housing element (308) moves towards the dispensing position. 33. The device according to claim 31 or 32, wherein when the needle guard (316) is moved towards the second projection, the projections (514) move along the side wall portions (632) and cause -