EA044579B1 - METHOD FOR ADMINISTRATION OF A MEDICINE FROM A DEVICE FOR DELIVERY OF A MEDICINE ACTUATED BY THE PALM OF THE HAND - Google Patents

Description

This application claims priority under 35 USC § 119 and/or § 120 based on U.S. Provisional Patent Application No. 61/361983, filed July 7, 2010, and 61/252378, filed October 16, 2009, contents which are incorporated herein by reference in their entirety.

Field of invention

In general, the invention relates to methods and devices for delivering drugs by the parenteral route. The devices are designed for manual delivery of medicinal substances with confirmation of completion of the medicinal substance 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 underdoses or wasted drug use. , and also provides an easy-to-use enhanced security system.

Prerequisites for creating the invention

For many years, parenteral administration of drugs was carried out in the only generally accepted way, namely with a syringe and needle. The syringe contains a certain amount of the 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 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 medications as prescribed due to fear of needles, pain typically associated with injections, lack of dexterity required to properly administration of medicinal substances using a needle and syringe or other similar factors. For some people who have vision, motor, or sensory impairments, self-administration of a drug with a needle and syringe presents additional challenges that may prevent them from getting the drug treatment 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 necessary drugs is the ability to control the insertion of the needle and the rate of delivery of drugs by pressing the plunger of the syringe, and therefore the ability to control the pain and discomfort associated with this type injection of medicinal substances.

Over time, improvements have been made to facilitate self-administration of medications. These include reducing the thickness of the needles and improving the geometry of the tip, 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 ballpoint-type body 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 retracting or by placing it around protective case needles.

Although such modifications have improved needle and syringe drug delivery, ergonomic designs, pen syringes, and auto-injectors essentially remain similar to the original needle and syringe concept, thereby limiting the degree of acceptance by patients requiring self-administration of medications. Current systems use a form factor that uses the common skin fold and prick injection technique, where the user holds the device with their hand and their thumb is placed on the trigger 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 is exacerbated in cases of delivery of very expensive drugs that must be administered once a week or less.

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The typical way to use modern auto-injectors involves the patient holding the device against the skin for a few seconds while the device delivers the drug. Many users, particularly older adults, 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 medicinal substance, increased discomfort, etc. In any case, modern devices and methods using or developed on the basis of 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 using ampoules to fill empty syringes at or near the time of drug administration may be the most cost-effective solution, it creates the additional potential for wastage or wastage of expensive medication. If the storage conditions of the drug product involve the use of low temperatures, each time the drug is removed and re-placed into 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 to be delivered to 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 to be used 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 drugs, 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's body. On the other hand, too high a spring force results in drug delivery too quickly, causing drug degradation or pain at the injection site due to rapid delivery of the acidic drug or 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.

The essence of the invention

A method is provided for administering a medicinal product from a drug delivery device comprising an upper housing, a lower housing, a syringe supported by the lower housing and having a needle, and a needle guard supported by the lower housing, comprising the steps of:

pressing the drug delivery device to the surface of the skin, so that the protective tip of the needle abuts the surface of the skin, while the upper housing is locked, with the possibility of release, relative to movement in the direction of the needle;

force is applied to the upper body along the direction of insertion, so that the needle guard is retracted, under the action of the skin surface, relative to the lower body and thereby exposes the needle, so that the needle penetrates the skin surface, and this step of application of force results, through the guard needles, to unlock the upper housing relative to movement in the direction of the needle; and continue to apply force to the upper body along the direction of insertion, so that the upper body moves in the direction of the needle, thereby displacing the drug contained in the syringe through the needle.

In preferred embodiments, the step of continuing to apply force includes advancing the plunger into the syringe so that the drug is expelled through the needle.

The upper housing is released relative to movement in the direction of the needle when the needle guard has completed its movement relative to the lower housing.

The drug delivery device includes a latch that cooperates with the upper housing so that the upper housing is locked, releaseable, relative to movement in the direction of the needle, and the unlocking step includes bringing the needle guard into contact with the latch and displacing the latch from the upper housing, thereby most unlocking the upper housing.

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In one embodiment, the method includes removing the drug delivery device from the surface of the skin along a direction opposite to the direction of administration so that the needle is withdrawn from the surface of the skin. Said removal step involves advancing the needle guard relative to the needle so that the needle is substantially hidden. Said removal step further includes preventing the needle guard from being retracted relative to the needle.

The method may further include, after the step of continuing to apply force, the step of preventing the upper body from being retracted from the needle.

In one embodiment, a drug delivery device is used, further including a middle body coupled between the upper body and the lower body, and the force application continuation step includes translational movement of the upper body over the middle body, thereby providing a visual indication of drug delivery. This translational step involves substantially completely concealing the middle housing by the upper housing, thereby indicating complete dispensing of the medicinal product.

Also provided is a method for administering a drug from a drug delivery device comprising an upper body, a lower body, a middle body having a portion visually open between the upper body and the lower body, and a syringe supported by the lower body and having a needle, including steps in which :

pressing the drug delivery device to the skin surface;

moving the drug delivery device towards the skin surface along the direction in which the needle penetrates the skin surface;

applying a force to the upper body along said direction, thereby moving the upper body along the middle body in the direction of the needle, such that the upper body moves translationally over the middle body as the upper body moves in the direction of the needle, thereby providing a visual indication of the dispensing of the contents of the syringe medicinal product.

In preferred embodiments, the force application step includes moving the upper housing along the middle housing until a first surface of the lower housing mates with a corresponding second surface at the distal end of the upper housing. The method may further include providing haptic feedback when the first surface of the lower housing is mated with a corresponding second surface.

At the appropriate step, the drug delivery device is pressed against the skin surface so that the needle guard rests on the skin surface, while the upper housing is locked, with the possibility of release, relative to movement in the direction of the needle.

In said moving step, a force is applied to the upper body along said direction so that the needle guard supported by the lower body is retracted by the action of the skin surface relative to the lower body and exposes the needle so that the needle penetrates the skin surface.

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 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, showing the latch.

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

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.

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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 medicinal substance.

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 of the embodiment shown in FIG. 10A.

In fig. 13B is a perspective view of the middle body 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 shown in FIG. 10A.

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

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

In fig. 21B is a perspective view of an alternative embodiment of the lower housing of the embodiment shown in FIG. 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 should be interpreted in light of the illustrations, in which like elements appear under like numerals in different drawings. The embodiments of the invention shown in the figures, not necessarily to scale, are for illustrative and explanatory purposes only and are not intended to limit the scope of the invention in any way. The detailed description discloses the principles of the present invention by way of examples, which do not limit the scope of the present invention.

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 needle-borne infection. The device involves automatic hiding of the needle after delivery of the medicinal substance.

Embodiments of the device have an ergonomic form factor that allows one-handed operation of the device and alternating injection sites, such as injecting into the thigh, shoulder, or abdomen. In pressure-activated embodiments, the needle guard latch 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 allowing the medicinal substance to be viewed 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 delivery of the drug substance, increased safety is ensured and the risk of accidental needle sticks is minimized.

To ensure that the user is aware of the drug delivery status and completion of delivery, this embodiment includes a ratchet pawl and a ratchet mechanism, such as the ratchet pawl 117 and the ratchet 116 in FIG. 4 and 7, which produce one or more audible clicks upon completion of the injection. This mechanism alerts 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. 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 user feedback, the exposed 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 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 injection of the drug itself, as described below.

Figures 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 an injection of a medicinal substance, 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.e. in the form in which the device arrives to the user. In this free position, the upper housing 101 partially covers the proximal or uppermost portion of the lower housing 102. In the description of various embodiments of the device, the term proximal is used in relation to the lower surface of the device. For example, in FIG. 1B, proximal is the bottom surface or lower portion 131 of the device 100.

As shown, externally visible elements of the device include upper housing 101, lower housing 102, cap 103, window 104, lock button 105, clamp ring 106, lower edge 111 of upper housing 101, and dose indicator 107. In FIG. 3 embodiment 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 placed on the lower 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 slot of the needle guard 109 (each of which is preferably present on both sides of the device) allow the user to view and control the syringe 118 located inside the housing and contained in there is no medicinal substance.

In practice, the palm device is grasped over the upper 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, 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 gripping 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 forces it downward, as shown in FIG. 1C, which in turn releases the latch of the needle guard 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 latch 124 is integral with a portion of the distal end of the upper adapter 120. The upper adapter 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 is flexibly coupled to the upper housing 101 and provides locking functions and also acts as a member to bias the trap 119 toward the lower housing 102, as will be described in detail below.

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The needle guard latch 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. To release the needle guard latch 124, an outwardly inclined surface 128, complementary to the surface 127 that forms the distal end of the released locking button 123, engages with an inclined surface 127 on the needle guard latch 124. When surfaces 127 and 128 engage, the needle guard latch 124 is deflected outwardly. relative to the central axis, moving the stop 130 from the position of blocking the movement of the needle guard 108 upward. 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, protects the user from accidental needle sticks, and hides the needle from view.

As the user continues to apply downward pressure to the upper housing 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 102 is firmly pressed against the skin and practically drowned in it. Once the needle guard 108 has passed the stop 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 takes advantage of a common method often used by insulin-dependent diabetics: 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 102, is shown in a closed state and prevents movement of the upper housing 101 relative to the lower housing 102 in the device's pre-use state (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 inclined surface 133 on the needle guard 108 comes into contact with the inclined portion of the surface 134 forming the end of the housing latch 122, deflecting the housing latch 122 inward, thereby allowing downward movement of the upper housing 101 and the upper housing 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 pushes the piston 112 forward. The piston rod 115 is fixedly attached to the upper body 101, and the syringe 118 is securely fastened or held in a cylinder formed inside the lower body 102. Thus, when the upper body 101 moves downward relative to and along the lower housing 102, the medicinal substance within the syringe 110 is delivered to the patient through the needle 110 by moving the piston rod 115 and piston 112 downward within the syringe 118.

Upon release of the housing latch 122, the biasing member 119 surrounding the distal end of the adapter sleeve of the upper housing 120 is released from the tension state by exerting a downward force on the upper housing 101 by applying a downward force to the adapter sleeve of the upper housing 120, the uppermost end of which is fixed to upper housing 101. The biasing element 119 may also serve to supply the energy required to propel the piston rod 115 and piston 112 forward, in combination with the additional necessary force applied by the user to ensure the injection of the medicinal substance, or the energy supplied by the biasing element 119 may be sufficient only to push the piston rod 15 and piston 112. In an alternative embodiment of the present invention, the biasing element 119 provides sufficient force to inject the medicinal substance 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 adapter sleeve of the upper housing 120, including, but not limited to, a spring, a pneumatic actuator, a hydraulic actuator, a wax actuator, an electrochemical actuator, or a memory alloy. forms, 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 push the piston rod 115 and piston 112 forward by applying downward pressure on the upper housing 101. Thus, the force required from the user to inject the medicinal substance is reduced in a manner similar to power steering in a vehicle, it reduces the effort required by the driver to rotate the steering wheel.

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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, 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 may perform at least the following two 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 quiet click is heard, providing feedback to the user that the upper housing 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 101, the pawl of the ratchet mechanism 117 may engage in a deeper notch in the ratchet mechanism 116, resulting in a louder click that is an audible signal to the user that the stroke has ended and delivery of the drug substance has been completed, and also results in locking the upper housing 101 in place to prevent the device from being returned to its original position and reused.

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

Before using the device, the patient can see the medicinal substance through the window 104, which makes it possible to monitor the transparency 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 painted in a bright color 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 return element of the needle guard 114 ensures that the needle guard 108 returns to its original position and hides the needle 110, thereby protecting the user and others from accidental needlesticks. The needle guard returner may be any element capable of returning the needle guard 108 to its original position and concealing 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 with an effect memorizing forms, etc., as well as combinations thereof. Once needle guard 108 is fully extended, needle guard retainer 125 engages a slot in needle guard 108 to prevent needle guard 108 from retracting. Needle guard retainer 125 is a sliding latch that extends inward from the inside surface of the upper housing adapter. 120. The protrusion of the lower housing 126, which is part of the lower housing 102, prevents the needle guard retainer 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 become locked in place when the device 100 is removed prior to completion of delivery, thereby 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 rate of delivery by varying the force applied to the upper housing 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 required in the worst-case scenario, when in reality the amount of force varies depending on the drug, cartridge, plunger, needle and the frictional force arising in the mechanism.

In another embodiment of the invention, the lock button 105 and the lock spring

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121 may not be provided for by the design. In this case, the upper housing 101 can freely move downwards until it stops. This movement is used to release the needle guard 108 using a mechanism similar to the locking mechanism described above, allowing the needle guard 108 to retract. Once the needle guard 108 is fully retracted, another latch is released, causing the upper housing 101 to stop moving downwards and perform injection of a medicinal substance by analogy with 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 205, a lower housing 202, and a middle housing 201 located between them. The upper housing 205 includes a clamp cap 228. In the free position, the upper housing 205 partially overlaps the proximal portion of the middle housing 201. The distalmost portion of the middle housing 201 is fixedly secured in the lower housing 202. Also in FIG. 10A shows the lower edge of the upper housing 211, the travel limiting projection 216, and the window 204. The window 204 is preferably located in the proximal portion of the lower housing 202. A second window (not shown) is preferably located 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 exposed needle sheath 213, needle sheath clamp 217, and needle guard 208. When cap 203 is removed, needle sheath clamp 217 engages and simultaneously removes needle sheath 213, exposing needle guard 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 an exploded state. The clamp cap 228 includes clamp cap assembly pins 230 that secure the clamp cap 228 to the upper housing 205. The assembly pins 230 mate with holes 242 in the upper housing 205. Preferably, the 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. Guides 233 and 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 housing 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 manufacturing the clamp cap include, 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 ridge 238, and a lower 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 located symmetrically with respect to each other to ensure smooth progress and operation of the device.

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

The main body 207 serves as a dose indicator because, upon activation of the device, the upper body 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 body 205, as shown in FIG. 11C. Preferably, the body body 207 is colored, more preferably brightly colored or patterned, to provide visual feedback to the user indicating delivery has occurred or is complete. If desired, a scale may be applied to the main body 207 to visually indicate the amount of drug delivered or remaining.

As shown in FIG. 13, the middle body 201 also includes clamp latches 224, retaining slots of a locking latch 236, and a needle guard latch 237. The clamp latch 224 is generally a rectangular member, the distalmost portion of which is movably connected to the inner surface 243 of the middle body 201, so that when subjected to force, it is capable of moving outwardly toward the inner surface 243. The latch 224 also has a stop surface 245 and a triangular stop 244 protruding from the corner of its highest portion inward toward the center of the device. When the device is at rest, the clamp latch 224, when in the pre-use position, blocks the movement of the upper housing 205 relative to the middle housing 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 base of the lower housing 206, the end of the stroke-limiting ridge 216, a window 204, a housing latch 229, guide slots 227 and a clip holding the syringe 235. The cap 203 is placed on the base of the lower housing 206 and is fixed. thereon by means of the retaining ring of the cap 234. In practice, the base of the lower housing 206 is in contact with the user's skin and thus 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 housing 202 that provides a view of the contents of the syringe 218. Window 204 is positioned so that the bottom of the syringe 218 is visible to the user to ensure that the plunger 212 has reached the end of its stroke towards 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 coincides with the longitudinal axis of the device and the syringe, thereby providing a view of the desired area of the syringe.

The guide slots 227 help maintain the correct alignment of three different elements: the guides 233 of the clamp cap 228; release mechanism of the clamping latch 231 and the mechanism for extending the protective cap of the needle 241. The guide slots 227 are designed to allow smooth activation of the device, maintaining the correct location and vertical stroke of the upper housing 202 and the protective cap of the needle 208, as well as reliable fixation and release of the clamping latch 231. Housing latch 229, projecting outwardly, secures the middle housing 201 to the lower housing 202 by engaging a recess (not shown) in the inner surface 243 of the middle housing 201. In non-reusable embodiments of the device, the shape of the latch 229 and the recess prevents the middle and lower body. In reusable embodiments of the device, the notch and latch configuration allows for the middle and lower housing to be separated.

As shown in FIG. 12, the needle guard 208 has a needle guard slot 209 formed on one side by a latch release mechanism 231 and on the other side by a needle guard extension mechanism 241. The latch release mechanism 231 has an inclined surface 240. As shown in FIG. 14 and 15, the inclined surface 240 of the release mechanism of the clamp latch 231 faces outward, and as the clamp latch 231 moves upward, it engages the inclined surface 244 on the clamp latch 224 facing inward, which causes the clamp latch 224 to deflect outward and eliminates 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 when the plunger in the syringe is at the end of its downward stroke. In addition, inside the lower part of the space formed by the release mechanism of the clamp latch 231 and the extension mechanism of the needle guard 241, there is a returner of the needle guard 214.

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 housing 213 and the damper 221, each of which is a flexible member that protects the syringe 218 if the device 200 is dropped or otherwise mishandled. 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, slight movement of the upper body 205 is allowed before the damper 221 comes into contact with the piston 212, and during the initial movement the downward damper 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 resting position as the gripper moves downward. When damper 221 moves quickly, air is not able to escape quickly enough to reduce the build-up of air pressure. Alternatively, damper 221 may have through-holes (not shown) to allow air to bleed behind damper 221. Alternatively, frictional resistance of the damper without pressure build-up, a damper that is neither air bleed nor speed dependent, or a combination thereof may be used. When damper 221 contacts piston 212, damper 221 is compressed inward toward piston rod 215, reducing friction between damper 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 202, which simultaneously removes the needle sheath 213 and exposes the needle guard 208. The user grasps the device 200 by the upper housing 205 by placing the palm of the hand on the clamp cap 228. and applies 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 to expose the needle 210. The pressure on the clamp cap 228 forces the needle 210 to penetrate 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 stroke within the lower housing 202.

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As shown in FIG. 15, when the needle guard 208 reaches the end of its stroke inside the lower body 202, the inclined surface 240 of the release mechanism of the clamp latch 231 comes into contact with the same angled but oppositely directed inclined surface 244 of the clamp latch 224 of the middle body 201, resulting in the clamp latch 224 is deflected toward the inner wall 243 of the middle housing 201. As a result of this action, the abutment surface 245 of the clamp latch 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 205 to move downward over the middle housing 201 .

By moving the upper body 205 downward, the drug contained within the syringe 218 is delivered through the needle 210 as the piston rod 215 and the damper 221 of the clamp cap 228 press downwardly on the plunger of the syringe 212. At the end of drug delivery, the main body the housing 207 is almost completely covered by the upper housing 205, and the lower edge 211 of the upper housing 205 mates with the stroke-limiting protrusion 216 of the lower housing 202 having a corresponding shape. Piston rod 215, damper 221, and piston 212 are also clearly visible in window 204. All of these elements serve to visually confirm completion of drug delivery, and the bottom edge 211 firmly rests on the stroke limiting projection 216 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 locking latch 220 is deflected outwardly as its inclined plane 247 contacts and slides against the top of the middle body 201. When the inclined plane 247 moves far enough in the downward direction, the inclined plane 247 is aligned 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 in the proximal portion of the middle body 201 and latching onto the outer surface of the main body 201. parts 207 of the middle body 201, making a clicking sound. In non-reusable embodiments of the device, the retaining 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 locking latches 220 are positioned 180 degrees opposite each other, providing smooth activation of the device and facilitating latching.

When the user removes the device 200 from the skin, the needle guard returner 214 (the spring shown in FIG. 12), which was compressed when the device 200 was pressed against the user's skin, expands, allowing the needle guard 208 to extend downward and conceal the needle 210. , 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 latch 232 engages the stop 248 shown in FIG. 13 on the lower housing 202 to prevent the needle guard 208 from being separated from the lower housing 202. In FIG. 16 shows a 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 is deflected outwardly, coming into contact with the outer surface of the guide 233 or the guard extension mechanism. needle guard 241. As the needle guard 208 moves downward and extends to conceal the needle 210, the needle guard latch 237 fits onto the top of the needle guard extension mechanism 241, preventing the needle guard 208 from retracting.

Before use, the extension mechanism 233 guides of the clamp cap 228 hold the needle guard latch 237 in an outwardly deflected position allowing the needle guard 208 to retract to insert the needle 210. Two needle guard latches 232 and needle guard latches 237 are preferably used and spaced 180 apart. 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, preventing 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 complete, the needle guard 208 is retracted but not locked in place.

In fig. 19 illustrates an alternative, reusable embodiment of device 200 where the upper housing 205 and middle housing 201 are detachable 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 body.

In fig. 20 illustrates yet another alternative embodiment of apparatus 200 that includes an auxiliary drive 219. Use of the auxiliary drive 219

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Claims (5)

most justified when delivering viscous drugs. The auxiliary actuator 219 applies a force between the upper housing 205 and the middle housing 201, exerting downward pressure on the adapter sleeve of the upper housing 120. This reduces the required amount of downward pressure exerted by the user on the clamp cap 228 for the purpose of injecting the drug substance. 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. In an alternative embodiment, the assist drive 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 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 reusable latching 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 return of the needle guard 214. To install the buzzer 222, the user pushes one of the guides of the buzzer 225 until the latch of the buzzer 226 will not engage the sound signal 222, holding it in the pressed position. As the clamp cap 228 moves downward at the end of its stroke, the guide 233 comes into contact with an inclined 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 return of the needle guard 214. When the contact surface 223 of the audible alarm 222 comes into contact with the lower housing 202 and an audible click is heard, signaling completion of drug delivery. Compression of the needle guard returner 214 increases when the needle guard 208 is retracted during drug injection, thereby increasing the amount of force exerted on the audible alarm and increasing the click volume. Alternatively, the latching 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 hereby provided, but are not included in the accompanying figures. This includes a multiple dose design in which the upper or middle body, or both bodies together, are not fully utilized and when pressed by the user, a partial delivery of the dose contained in the syringe is achieved. CLAIM 1. A method of administering a medicinal product from a drug delivery device (100) comprising an upper housing (101), a lower housing (102), a syringe (118) supported by a lower housing (102) and having a needle (110), and a protective nozzle (108) needle supported by a lower housing (102), including steps in which: pressing the drug delivery device (100) to the surface of the skin, so that the protective nozzle (108) of the needle abuts the surface of the skin, while the upper housing (101) is locked, with the possibility of release, relative to movement in the direction of the needle (110); force is applied to the upper body (101) along the direction of insertion so that the needle guard (108) is retracted by the action of the skin surface relative to the lower body (102) and thereby exposes the needle (110) so that the needle (110) penetrates the surface of the skin, and this step of applying force leads, through the protective nozzle (108) of the needle, to unlock the upper housing (101) relative to movement in the direction of the needle (110); and continue to apply force to the upper body (101) along the direction of administration, so that the upper body (101) moves towards the needle (110), thereby displacing the drug contained in the syringe (118) through the needle (110). 2. The method of claim 1, wherein the step of continuing to apply force includes advancing the plunger into the syringe so that the drug is expelled through the needle. 3. The method according to claim 1, wherein the upper housing is unlocked relative to movement in the direction of the needle when the needle guard has completed its movement relative to the lower housing. 4. The method of claim 1, wherein the drug delivery device comprises a latch that cooperates with the upper housing such that the upper housing is locked and releasably relative to movement in the direction of the needle, and the unlocking step includes bringing the needle guard into contact with the latch and moving the latch away from the upper housing, thereby unlocking the upper housing. 5. The method according to claim 1, including removing the drug delivery device from the -