EA040210B1 - DRUG DELIVERY DEVICE ACTIVATED WITH THE PALM OF THE HAND - Google Patents

Description

This application claims priority under § 119 and/or § 120 of title 35 U.S.C.C. pursuant to U.S. Provisional Application No. 61/361983 filed July 07, 2010 and 61/252378 filed October 16, 2009 which are incorporated herein by reference in their entirety.

Field of invention

In general, the invention relates to methods and devices for parenteral drug delivery. Devices are designed for manual drug delivery with confirmation of the completion of the drug delivery process. The devices provide an easy-to-use, high-security system with audible or other feedback to the user that drug delivery is either in progress, complete, or both, avoiding underdose or wasted drug and also provides an easy-to-use advanced security system.

Prerequisites for the creation of the invention

For many years, the administration of drugs by parenteral route was carried out by the only generally accepted method, namely with a syringe and needle. The syringe contains a certain amount of drug, which is either already in the syringe (if the syringe is sold pre-filled with the drug), or is introduced into the syringe by drawing into the syringe from a glass or other ampoule. Syringes are widely used due to the low cost of production 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 drugs is necessary, such as for treatments that require multiple daily injections, patients may avoid administering drugs as prescribed due to fear of needles, pain usually associated with injections, lack of dexterity required for proper administration medicinal substances with a needle and syringe or other similar factors. For some people with impaired vision, movement or perception, self-administration of a drug with a needle and syringe presents additional difficulties that may prevent them from receiving the necessary medical treatment.

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

Improvements have been made over time to facilitate self-administration of drugs. These include reducing the thickness of the needles and improving the geometry of the tip, which can reduce pain. To minimize the chance of accidental needle stick, safety syringes are used in which the needle remains covered before, after, or both before and after use. In addition, options have been 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 ballpoint pen body have been developed, and in order to relieve patient fear and address the issue of safety, autoinjectors are used, where the needle is hidden from the patient either by retraction or by being placed around protective case needles.

While these modifications have improved needle and syringe delivery of drugs, the ergonomic design, pens, and autoinjectors essentially remain similar to the original needle and syringe concept, thus limiting acceptance by patients requiring self-administration of drugs. Current systems utilize a form factor that utilizes the common skin-fold and quick-prick injection technique, where the user holds the device with their hand and their thumb is placed on the trigger.

Modern autoinjectors place the control of drug delivery into the body on a mechanical system. Since such a system is highly dependent on the specific mechanical design of the autoinjector, patients may need specialized training in the use of the device, while still risking inaccurate dosing. This situation is exacerbated in the case of delivery of very expensive drugs, which must be administered once a week or less frequently.

- 1 040210

The usual way of using modern autoinjectors involves the patient holding the device close to the skin for several seconds while the device delivers the drug. Many users, particularly the elderly, 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 above two situations can lead to inaccurate dosing, excessive consumption of the medicinal substance, increased discomfort, etc. In any case, modern devices and methods using or based on the traditional system of syringes and needles have disadvantages that reduce the effectiveness of the prescribed drug regimen.

Finally, as with any medical device or health care service, the cost of all commonly used components of a treatment regimen must be considered. While the use of ampoules to fill empty syringes at or shortly before drug administration may be the most cost-effective solution, it creates the additional possibility of wasting or wasting an expensive drug. If the storage conditions of the medicinal product involve the use of low temperatures, each time the drug is removed and re-placed in a cooling device before filling the syringe and after that, the quality of the drug deteriorates, which leads to a decrease in the expected effectiveness if the amount of drug contained in the ampoule is designed to deliver in over a long period of time. Although pre-filled syringes are more reliable and convenient, they also suffer from the previously listed disadvantages.

With regard to devices such as pre-filled autoinjectors, they are usually designed for use with a wide range of drugs, but are specifically adapted for use with only one drug. Because such devices place control of the rate of drug injection on mechanical systems that incorporate springs, many drugs that have different viscosities or require refrigeration and that change viscosities significantly as a result of temperature change are delivered too quickly or too slowly due to predetermined spring rates. effort provided by the design of the autoinjector. In many cases, too low a spring force results in incomplete delivery of drugs, removal of the device before delivery is complete, or increased pain and discomfort to the user due to the prolonged period of insertion of the injection device into the patient's body. On the other hand, too high spring force leads to too rapid delivery of drugs, which causes degradation of drugs or pain at the injection site due to rapid delivery of an acid-containing drug or pressure gradient under the skin or in a vein.

Thus, there are good prospects for improvements in the field of episodic parenteral drug delivery that will help overcome needle phobia, reduce patient pain, and improve the safety, reliability, and efficacy of many drug regimens.

Brief description of the figures

In FIG. 1A is a side view of an embodiment of the present invention;

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

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

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

in fig. 2A is a side view of the embodiment 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 completion of drug injection;

in fig. 2C is a side view of the embodiment shown in FIG. 2B, after pulling out 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 showing a latch;

in fig. 6 is a partial cross-sectional view of a portion of the embodiment shown in FIG. 1A showing a 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;

- 2 040210 in FIG. 10A is a side view of another embodiment of the present invention;

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

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

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

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

in fig. 11C is a side view of the embodiment shown in FIG. 11B after pulling out 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 of the embodiment shown in FIG. 10A;

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

in fig. 14 is a partial cross-sectional view of a portion of the upper and middle housings 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 shown in FIG. 10A;

in fig. 17B is a perspective view of a portion of the lower housing 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 another embodiment of the present invention;

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

in fig. 21A is a perspective view of an alternative lower housing design of the embodiment shown in FIG. 10A;

in fig. 21B is a perspective view of an alternative lower housing of the embodiment shown in Figure 10A;

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

Detailed Description of the Invention and Preferred Embodiments

The following detailed description is to be read in conjunction with the illustrations, in which the same elements in different drawings are represented by the same numbers. The embodiments of the invention shown in the figures, not necessarily drawn to scale, are for illustration and clarification purposes only and do not limit the scope of the invention in any way. The detailed description discloses the principles of the present invention by means of examples, which do not limit the scope of the present invention.

The present invention provides a drug delivery device and methods of using the same, the present device avoiding many of the limitations and disadvantages of conventional syringes and needles, as well as autoinjector type devices. To overcome the limitations and disadvantages of previous devices and meet the needs in the art, embodiments of the device and methods disclosed herein include a device whose design does not allow the user to see the needle or touch the needle, thereby reducing the fear of needles and the risk of potential infection through the needle. The device involves automatic hiding of the needle after the delivery of the medicinal substance.

Embodiments of the device have an ergonomic form factor that allows the device to be operated with one hand and alternate injection sites, such as injecting into the thigh, upper arm, or abdomen. In pressure-triggered embodiments, the latch of the needle guard prevents the needle from moving. Thus, the device contains a safety mechanism that will not allow the needle to be exposed without sufficient pressure on the injection site.

In FIG. 1A-1D show one embodiment of the device of the invention which has a window 104 to allow the drug substance to be seen prior to use. After using the device, a color indicator appears in the window to visually indicate the consumption of the medicinal substance contained in the device. In addition, after drug delivery

- 3 040210 this substance provides increased safety and the ultimate reduction in the risk of accidental needle stick.

To ensure that the user is aware of drug delivery status and completion of delivery, this embodiment includes a ratchet pawl and a ratchet, such as ratchet pawl 117 and ratchet 116 in FIG. 4 and 7, which, upon completion of the injection, emit one or more audible clicks. Such a mechanism signals to the user that a dose of drug has been delivered and that the device can be removed, thereby preventing premature removal of the device from the injection site. Thus, the user is actively involved throughout the entire delivery process, unlike traditional auto-injectors where the user has to wait a few seconds to ensure that the dose is complete.

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

Moreover, the present invention has a convenient, non-intimidating design and mode of operation, unlike traditional needle safety devices and autoinjectors 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 course 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. 1A-1D show an embodiment of the device at various stages of preparation for performing drug injection, and FIG. 2A-2C show an embodiment of the invention during and after drug injection. In FIG. 1A shows device 100 in a pre-use configuration, i. in the form in which the device is delivered to the user. In this free position, the upper body 101 partially covers the proximal or uppermost portion of the lower body 102. In describing various device embodiments, the term proximal is used to refer to the bottom surface of the device. For example, in FIG. 1 Proximal is the lower surface or lower portion 131 of device 100.

As shown, externally visible elements of the device include the upper body 101, the lower body 102, the cap 103, the window 104, the lock button 105, the clamp ring 106, the lower edge 111 of the upper body 101, and the dose indicator 107. In FIG. 3 is an exploded view of the present invention.

At the preparatory stage of using the device, it is necessary to remove the cap 103, which is put on the lower body 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 slot in the needle guard 109 (each of said features preferably present on both sides of the device) allow the user to view and control the syringe 118 located within the housing and contained in the him a medicinal substance.

In practice, the palm of the hand device is gripped over the upper housing 101, in a manner similar to gripping a gearshift lever in a car. The grip ring 106 provides the user with a visual guide to properly grip the device. In one embodiment, the grip 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 depresses 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, usually on the top or side of the upper thigh, on the abdomen, or on the top or back of the upper arm. Palm pressure on the lock button 105 moves it down, as shown in FIG. 1C, which in turn releases the latch of the needle guard 124, as shown in Figure 5, allowing the needle guard 108 to slide upward and expose the needle 110 (it should be noted that some of the elements of the device in FIG. 5 are not shown for illustrative purposes). The latch of the needle guard 124 is integral with a part of the distal end of the upper adapter sleeve 120. The upper adapter sleeve 120 is a hollow cylinder, part of which is located in the upper housing 101, and part of which is located in the lower housing 102 when the device is at rest. The upper adapter sleeve 120 has a flexible connection with the upper housing 101 and performs the functions of blocking, and also acts as an element that biases the trap 119 to the lower housing 102, as described in detail below.

The latch of the needle guard 124 on the inner side with respect to the longitudinal central axis A-A' of the device has an inclined surface 127 and a stop 130 at its uppermost end.

- 4 040210

To release the latch of the needle guard 124, the outwardly inclined surface 128, complementary to the surface 127 forming the distal end of the depressed lock button 123, engages with the inclined surface 127 on the latch of the needle guard 124. When surfaces 127 and 128 engage, the latch of the needle guard 124 deviates outward along relative to the central axis, moving the stop 130 from the position of blocking the movement of the needle guard 108 upwards. The locking mechanism and needle guard 108 are preferably configured to prevent the needle guard 108 from moving upward unless the lock button 105 is fully depressed. This protects the needle from contamination and damage from contact with other surfaces, protects the user from accidental needle sticks, and hides the needle from view.

As the user continues to exert downward pressure on the upper body 101, the needle guard 108 moves upward, exposing the needle 110 and allowing it to penetrate the patient's skin, stopping when the bottom surface 131 of the lower body 102 is firmly pressed against the skin and practically drowned in it. Once the needle guard 108 is past the stop 130, the user may or may not release the lock button 105 without affecting the remaining injection steps. When the lock button 105 is released, the resilient element 121 returns the lock button 105 to its upper position. The movement guide 132 allows the lock button to move in a straight line up and down.

The needle insertion process described herein allows the user to control insertion independently. This takes advantage of a common technique often used by insulin-dependent diabetics: if the needle contacts the skin and is held in that position without being pierced, the user will no longer feel the needle after a few seconds. Thus, at this point, the needle can be inserted painlessly by applying pressure to it.

Once the needle 110 has been 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 102, is shown in the closed state and prevents movement of the upper housing 101 relative to the lower housing 102 in the state of the device prior to use (it should be noted that some elements of the device in Fig. 6 are not shown for illustrative purposes). Upon completion of the upward movement of the needle guard 108, the sloping surface 133 on the needle guard 108 comes into contact with the sloping portion of the surface 134 forming the end of the body latch 122, deflecting the body latch 122 inward, thereby allowing downward movement of the upper body 101 and the upper body adapter sleeve. 120.

After the needle 110 is inserted into the body, the user maintains pressure on the upper body 101. As shown in FIG. 3, 4, 7 and 8, the piston rod 115 advances the piston 112. The piston rod 115 is fixedly attached to the upper housing 101, and the syringe 118 is securely fixed or held in a cylinder formed inside the lower housing 102. Thus, when the upper housing 101 is moved down in relation to and along the lower housing 102, the drug inside the syringe 110 is delivered to the patient through the needle 110 by moving the piston rod 115 and the piston 112 down inside the syringe 118.

After the latch of the housing 122 is released, the bias member 119 surrounding the distal end of the upper housing adapter sleeve 120 comes out of tension by exerting a downward force on the upper housing 101 by applying a downward force to the upper housing adapter sleeve 120, the uppermost end of which is fixed to upper housing 101. The biasing element 119 can also be used to deliver the energy required to move the piston rod 115 and the piston 112 forward, in combination with the additional force required by the user to ensure the injection of the medicinal substance, or the energy supplied by the biasing element 119 can only be sufficient to push the piston rod 15 and the piston 112. In an alternative embodiment of the present invention, the biasing element 119 provides sufficient force to effect the injection of the drug without additional effort on the part of the user: thus , an injection device is proposed in which the needle is inserted manually and the drug is injected automatically. Any element capable of applying a downward force to the adapter sleeve of the upper housing 120 can be used as the biasing element, including, but not limited to, a spring, an air actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, a memory alloy. shapes, etc., as well as combinations thereof. In the embodiment of the invention shown in FIG. 1-9, the user exerts the additional force required to move the piston rod 115 and piston 112 forward by downward pressure on the upper housing 101. Thus, the force required from the user to inject the drug is reduced, similar to how power steering in a car reduces the effort required by the driver to turn the steering wheel. Unlike traditional auto-injectors, the user participates in the force needed to deliver the injection, and the present invention provides the user with control over the rate.

- 5 040210 drug injections.

In FIG. 4 and 7 show cross-sectional views of embodiments of the present invention before and after drug delivery, respectively. During drug delivery, the ratchet pawl 117 attached to the adapter sleeve of the upper housing 120 moves along the ratchet 116 attached to the lower housing 102. The ratchet pawl 117 and the ratchet 116 can perform at least two of the following functions. First, when disengaged, they prevent the upper housing 101 from separating from the lower housing 102. Second, as the ratchet pawl 117 moves along the ratchet 116, a soft click is heard providing feedback to the user that the upper housing 101 is moving. and drug delivery is in progress. In addition, as shown in FIG. 8, at the end of the stroke of the upper housing 101, the pawl of the ratchet 117 may engage a deeper recess in the ratchet 116, resulting in a louder click, which is an audible signal to the user for the end of the stroke and completion of drug delivery, and also as a result of this fixing the top case 101 in place to prevent the device from returning to its original position and being reused.

As shown in FIG. 2B and 8, when drug injection is complete and the upper body 101 is at the end of its stroke, the lower edge 111 of the upper body 101 covers the dose indicator 107. The dose indicator 107 is a colored ring running around the perimeter of the circumference on the distal portion of the lower body 102. It serves as a visual guide for the user, indicating the completion of drug delivery.

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

As shown in FIG. 2C and 9, after injection, the user removes the device 100 from the skin surface, and the needle guard return 114 causes the needle guard 108 to return to its original position and hide the needle 110, thereby protecting the user and others from accidental needle sticks. Any element capable of returning the needle guard 108 to its original position and concealing the needle 110 may be used as the needle guard returner, including but not limited to a spring, an air actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, an alloy effect shape memorization, etc., as well as combinations of these. After the needle guard 108 is fully extended, the needle guard lock 125 engages the slot in the needle guard 108, preventing the needle guard 108 from retracting. 120. The protrusion of the lower housing 126, which is part of the lower housing 102, prevents premature engagement of the needle guard lock 125 in the slot in the needle guard 108 during delivery by blocking the slot. In another embodiment of the present invention, the needle guard 108 may protrude and lock into place when the device 100 is removed prior to completion of delivery, thus preventing reuse of the device or sharing of the device.

The forced delivery method of the present invention allows the user to take an active part in 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 completion of drug delivery, without being able to accurately determine whether the injection has taken place or not.

An additional advantage of the forced delivery method of the present invention is the reduction of rework time and costs associated with the modification and adaptation of the injection device for the delivery of various drugs, due to the fact that the user has the ability to control the delivery rate by changing the force on the upper body 101 If the plunger is slightly stuck, the user can apply more force, unlike traditional autoinjectors, which are designed with the amount of force required in the worst case, while in reality the amount of force varies depending on the drug, cartridge, plunger, needle and the friction force that occurs in the mechanism.

In another embodiment, the lock button 105 and lock spring 121 may be omitted. In this case, the upper body 101 can freely move down to the stop. This movement is used to release the needle guard 108 when

- 6 040210 assistance of a mechanism similar to the locking mechanism described above, which ensures the retraction of the protective cap of the needle 108. After the protective cap of the needle 108 is fully retracted, another latch is released, which ensures that the movement of the upper body 101 in the downward direction stops and the injection of the medicinal substance is performed in the same way as described above way.

In FIG. 10-18 show another embodiment of the invention. In FIG. 10A shows a device 200 having an upper case 205, a lower case 202, and a middle case 201 disposed therebetween. The upper body 205 includes a clamping cap 228. In the free position, the upper body 205 partially extends over the proximal portion of the middle body 201. The most distal portion of the middle body 201 is fixedly fixed in the lower body 202. Also in FIG. 10A shows the lower edge of the upper body 211, the travel-limiting ledge 216, and the window 204. The window 204 is preferably placed in the proximal portion of the lower body 202. The second window (not shown) is preferably placed on the side opposite the window 204.

The cap 203 is placed on the lower body 202, and in FIG. 10B, device 200 is shown uncapped with needle sheath 213 exposed, needle sheath clip 217, and needle shield 208. When cap 203 is removed, needle sheath clip 217 engages and simultaneously removes needle sheath 213, exposing needle shield 208 and making it visible to the user. When the user of the device presses the needle guard 208 against the skin, the needle guard 208 slides upward to expose the needle 210 as shown in FIG. 10C.

In FIG. 12 shows the device 200 in a disassembled state. Clamp cap 228 includes clamp cap assembly pins 230 that secure clamp cap 228 to upper body 205. Assembly pins 230 mate with openings 242 in upper body 205. Preferably, assembly pins 230 have a square cross-section with rounded corners to provide a streamlined surface between the corners. assembly pins 230 and 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 damper 221 located at its distal end. Also shown is a syringe 218 with a plunger 212 and a needle sheath 213.

In a preferred embodiment of the invention, the outer surface of the clamp cap 228 is covered or made (or the entire clamp cap 228 is made) of a material that provides a soft, non-slip grip surface for the user. Suitable materials for coating or making the clamp cap are, among others, elastomers such as neoprene rubber, urethane, polyurethane, silicone, natural rubber, TPE, and the like. or combinations thereof.

The upper housing 205 includes a locking latch 220, a handle guide comb 238, and a bottom edge 211. With regard to the locking latch 220, as well as other latches used in the device, it is preferable to use at least two latches arranged symmetrically with respect to each other to ensure smooth the course and operation of the device.

The middle body 201 is shown in FIG. 12, showing its main body 207 and the guide slots of the handle 239 on the outer surface of the proximal portion of the main body of the body 207. During use of the device, the guide ridges of the handle 238, which are integral with the upper body 205, engage with the guide slots of the handle 239 and slide over them. , providing a smooth ride and controlled movement of the upper body 205 during drug delivery.

The main body 207 serves as a dose indicator because when the device is activated, the top body 205 descends over the main body 207. After a full dose of drug has been delivered, the main body 207 is completely hidden under the top body 205, as shown in FIG. 11c. Preferably the main body 207 is colored, more preferably a bright color or patterned to provide visual feedback to the user indicating delivery is in progress or completed. If necessary, a scale can be applied to the main part of the body 207, visually reflecting the amount of delivered or remaining medicinal substance.

As shown in FIG. 13, the middle body 201 also includes clamp latches 224 holding the slots of the locking latch 236 and the latch of the needle guard 237. The clamp latch 224 is generally a rectangular element, the distal end of which is movably connected to the inner surface 243 of the middle body 201, so that under the action of force it is able to move outward towards the inner surface 243. The clamping latch 224 also has a stop surface 245 and a triangular stop 244 protruding from the corner of its highest part inwards towards the center of the device. When the device is at rest, the clamp latch 224, in its pre-use position, blocks the movement of the upper body 205 relative to the middle body 201 due to the stop 245, which prevents the guides 233 of the clamp cap 228 from lowering.

As shown in FIG. 12 and 13, the lower housing 202 has a lower housing base 206, the end of a travel-limiting ridge 216, a window 204, a housing latch 229, guide slots 227, and a clip retaining a syringe 235. The cap 203 is put on the base of the lower housing 206 and fixed

- 7 040210 it through the retaining ring of the cap 234. In practice, the base of the lower body 206 is in contact with the skin of the user and, thus, should preferably be made of soft elastic materials suitable for the manufacture of the clamping cap 228.

Window 204 is formed by an opening in lower housing 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 verify that piston 212 has reached the end of its stroke towards the bottom of the syringe. The window 204 may be of any convenient size and shape, preferably it is oblong, and its longitudinal axis coincides with the longitudinal axis of the device and the syringe, thus providing a view of the desired area of the syringe.

The guide slots 227 make it possible to maintain the correct position of three different elements: the guides 233 of the clamping cap 228; latch release mechanism 231 and needle guard extension mechanism 241. Guide slots 227 are designed to smoothly activate the device, maintaining the correct position and verticality of the upper body 202 and needle guard 208, as well as securely locking and releasing the clamp latch 231. 229 protruding outwardly secures the middle body 201 to the bottom body 202 by engaging a notch (not shown) in the inner surface 243 of the middle body 201. lower body. In reusable embodiments of the device, the notch and latch configuration provides for separation of the middle and bottom housings.

As shown in FIG. 12, the needle guard 208 has a needle guard slot 209 formed on one side by the latch release mechanism 231 and on the other side by the needle guard extension mechanism 241. The latch release mechanism 231 has an inclined surface 240. As shown in FIG. 14 and 15, the sloping surface 240 of the release mechanism of the latch 231 faces outward, and as the latch 231 moves upward, it engages the sloping surface 244 on the latch 224 facing inward, causing the latch 224 to tilt outward and remove the obstruction to the movement of the guides 233. and 205 down.

The slot in the needle guard 209 allows a window 204 to be used to view the syringe and plunger when the plunger in the syringe is at the end of its downward stroke. In addition, inside at the bottom of the space formed by the latch release mechanism 231 and the needle guard extension mechanism 241, there is a needle guard returner 214.

An inventive aspect of the device 200 is the method of placing the syringe 218 within the device. As shown in FIG. 12, 13 and 17, the syringe 218 is held between the needle sheath 213 and the damper 221, each of which is a flexible element and protects the syringe 218 in the event of a fall or other mishandling of the device 200. When the device is in the assembled state, the syringe 218 is freely held in the cavity 246 of the lower body 202 using retaining clips 235. Depending on the volume of drug inside the syringe 218, during use of the device, a slight displacement of the upper body 205 is allowed before the damper 221 comes into contact with the piston 212, and during the initial movement downwards, damper 221 acts as an air piston in the space between the rod end of piston 215 and piston 212, which provides a speed-dependent resistance to the initial position during the downward movement of the gripper. When the damper 221 is moved rapidly, the air does not have a chance to exit quickly enough to reduce the buildup of air pressure. Alternatively, damper 221 may have through holes (not shown) allowing air to bleed behind damper 221. Alternatively, damper friction resistance without pressure buildup, use of a damper that is neither bleed nor velocity dependent, or a combination of the two is acceptable. Upon contact of the damper 221 with the piston 212, the damper 221 is compressed inwardly towards the piston rod 215, reducing the friction between the damper 221 and the inner surface of the cavity 246.

As shown in FIG. 10 and 11, when using the device 200, the user removes the cap 203 from the lower body 202, which simultaneously removes the needle sheath 213 and exposes the needle guard 208. The user grasps the device 200 by the upper body 205 by placing the palm of the hand on the clamping cap 228, and presses with a downward force on the clamp cap 228, while pressing the device 200 to the desired injection site on the body, while under the action of pressure the needle guard 208 slides up, exposing the needle 210. By applying pressure on the clamp cap 228, the needle 210 penetrates through skin and subcutaneous tissue, stopping when the base of the lower housing 206 contacts the surface of the skin or when the ridge 245 along the needle guard 208 reaches the end of its travel inside the lower housing 202.

As shown in FIG. 15, when the needle guard 208 reaches the end of its stroke inside the lower housing 202, the slant surface 240 of the latch release mechanism 231 comes into

- 8 040210 contact with having the same angle, but oppositely directed inclined surface 244 of the latch 224 of the middle body 201, as a result of which the latch 224 deviates towards the inner wall 243 of the middle body 201. As a result of this action, the abutment surface 245 of the latch 224 no longer obstructs the downward movement of the guide 233 of the clamping cap 228, releasing the guide 233 and allowing the upper body 205 to move downward over the middle body 201.

The downward movement of the upper body 205 delivers the medicament contained within the syringe 218 through the needle 210 as the piston rod 215 and the damper 221 of the clamp cap 228 are pressed with a downward force on the plunger of the syringe 212. At the end of drug delivery, the bulk housing 207 is substantially completely enclosed by upper housing 205, and the lower edge 211 of upper housing 205 mates with a properly shaped travel-limiting lip 216 of lower housing 202. The piston rod 215, damper 221, and piston 212 are also clearly visible in the window 204. All of these elements serve to visually confirm the completion of drug delivery, and the firm stop of the lower edge 211 against the travel-limiting protrusion 216 provides tactile feedback to the user.

In addition, at the end of drug delivery, a latching mechanism is activated, providing audible feedback. As shown in FIG. 14, the locking latch 220 deflects outwardly when its inclined plane 247 contacts and slides over the top of the middle housing 201. When the inclined plane 247 moves far enough in the downward direction, the inclined plane 247 aligns with the retaining slot of the locking latch 236, and the inclined plane 247 enters the retaining slot 236, the slot passing through the wall at the proximal portion of the middle body 201 and snapping onto the outer surface of the main body. part 207 of the middle body 201 by making a clicking sound. In non-reusable versions of the device, the locking latch 220 is permanently held in the retaining slot 236 and cannot be returned to its original position. In the preferred embodiment of the invention, the two locking latches 220 are positioned 180° opposite each other, allowing smooth activation of the device and facilitating snapping.

When the user removes the device 200 from the skin, the needle guard returner 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 to push the needle guard 208 down and hide the needle 210 , thus protecting the user from accidental jabs. In addition to the spring, as the needle guard returner, a pneumatic actuator, a hydraulic actuator, a wax element actuator, an electrochemical actuator, a shape memory alloy, and the like, as well as combinations thereof, may be used. When needle guard 208 is in the fully extended position, needle guard latch 232 engages stop 248, shown in Figure 13, on lower housing 202, preventing needle guard 208 from separating from lower housing 202. FIG. 16 shows the needle guard latch 237, the distal end of which is movably connected to the inner surface 243 of the middle body 201. As the needle guard 208 moves upward, the needle guard latch 237 deflects outward, coming into contact with the outer surface of the guide 233 or the guard extension mechanism. needle guard 241. In the process of moving the needle guard 208 down and retracting to conceal the needle 210, the needle guard latch 237 is pushed onto the top of the needle guard extender mechanism 241, preventing the needle guard 208 from retracting.

Prior to use, the extension guides 233 of the clamp cap 228 hold the needle guard latch 237 in an outwardly tilted position, allowing the needle guard 208 to be retracted for insertion of the needle 210. The two needle guard retainers 232 and the needle guard latch 237 are preferably used and spaced at a distance of 180 ° around the central axis of the device 200. If the device 200 is removed from the skin surface before drug delivery is complete, the needle guard 208 extends to hide the needle 210 and locks in that position preventing reuse of the device. In an alternate, reusable embodiment, if the device 200 is removed from the skin surface before drug delivery is complete, the needle guard 208 extends but does not lock into place.

In FIG. 19 shows an alternate embodiment of the reusable device 200 where the upper housing 205 and middle housing 201 are detached from the lower housing 202. In this embodiment, the user detaches the middle and upper housing, inserts the syringe 218 into the lower housing, and then reattaches to it the middle and upper case.

In FIG. 20 shows another alternative embodiment of the device 200, which includes an auxiliary drive 219. The use of an auxiliary drive 219 is most justified when delivering viscous drugs. Auxiliary drive 219 attached

- 9 040210 There is a force between the upper body 205 and the middle body 201, exerting downward pressure on the adapter sleeve of the upper body 120. This reduces the amount of downward pressure required by the user on the clamp cap 228 to perform drug injection. As the auxiliary drive 219, a spring, a pneumatic drive, a hydraulic drive, a wax drive, an electrochemical drive, a shape memory alloy, and the like, as well as combinations thereof, can be used. Alternatively, an auxiliary drive provides enough 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 is injected automatically, similar to traditional auto-injectors.

In FIG. 21 shows an alternative embodiment of the lower housing 202 of the device 200, which includes a repositionable snap-in mechanism for repeated use of the device. In this embodiment, the guide slots 227 engage with the guide 225 of the buzzer 222. The buzzer 222 is displaced by the needle guard returner 214. To install the buzzer 222, the user pushes one of the buzzer guides 225 until the buzzer latch 226 will not enter the buzzer 222 by holding it down. When the clamp cap 228 is moved downward at the end of the stroke, the guide 233 comes into contact with the sloped surface on the buzzer latch 226, deflecting it inward, releasing the buzzer 222 and allowing it to move upward under the force exerted by the needle guard returner 214. When the contact surface 223 of the buzzer 222 comes into contact with the lower housing 202, an audible click is heard, signaling the completion of drug delivery. The compression of the needle guard retractor 214 increases when the needle guard 208 is retracted during drug injection, increasing the amount of force exerted on the buzzer and increasing the volume of the click. Alternatively, the snap mechanism automatically resets when the user attaches the upper housing to the lower housing after loading a new syringe into the device.

Additional alternative embodiments of the present invention are provided herein, however, they are not included in the accompanying figures. This includes a multiple dose design in which the upper or middle housing, or both housings, are underutilized and, when pressed by the user, partial delivery of the dose contained in the syringe occurs.

Claims (10)

1. A device for the introduction of a medicinal product, containing a lower housing configured to support a syringe containing a needle, while the syringe is configured to contain a drug; an upper housing supported relative to the lower housing and movable relative to the lower housing in the direction of the needle from the first position to the second position; a piston rod held by the upper housing and configured to move with the upper housing to advance relative to the syringe when the upper housing is moved in said direction, wherein the movement of the piston rod relative to the syringe causes the syringe to dispense drug through the needle when the drug is contained in syringe; and a latch member configured to lock the upper housing in the second position to prevent the upper housing from moving from the second position to the first position after the upper housing has been moved to the second position from the first position. 2. The apparatus of claim 1, further comprising a middle housing positioned between the lower housing and the upper housing, the upper housing being further movable relative to the middle housing when the upper housing is moved from the first position to the second position. 3. The device of claim 2, wherein the latch element is mounted on the upper housing, the latch element cooperating with the middle housing to prevent the latch element from moving from the second position to the first position after the upper housing has been moved to the second position from the first position. 4. The apparatus of claim 3, wherein the middle housing defines a retaining slot configured to receive the latch element after the upper housing is moved to the second position from the first position. 5. The device according to claim 4, wherein the latch element is configured to produce audible - 10 040210 My click when the latch element engages in the retaining slot. 6. The device of claim 1 further comprising a needle guard movable relative to the lower housing to expose the needle when the lower housing is pressed against a skin surface. 7. The apparatus of claim 6, further comprising a second latch member that releasably engages with the upper housing when the upper housing is in the first position to prevent the upper housing from moving to the second position while moving the needle guard relative to the lower housing to expose of the needle leads to the elimination of the interaction, which ensures the movement of the upper body from the first position to the second position. 8. The apparatus of claim 7, wherein the needle guard comprises a contact surface with the second latch member and is configured to deflect the second latch member from engagement with the upper housing when the needle guard is moved relative to the lower housing to expose the needle. 9. The device of claim 8, wherein the surface causes the second latch member to deflect inwardly toward the central axis of the device when the needle guard is moved relative to the lower housing to expose the needle. 10. Apparatus according to claim 8, wherein the surface is sloped.