Not Applicable
Not Applicable
This invention relates to medical devices for delivering the medicine, specifically to an auto-injection apparatus for bringing media into the body in a subcutaneous, intramuscular way.
Nowadays in the market exist so many different types the auto-injector devices for self-administering injection, capable of delivering medications from the prefilled container with the needle to patients under emergency condition, such as to administer epinephrine to counteract the effects of a severe allergic reaction.
Moreover, some patients, however, can be averse to carrying out self-injection, particularly if the petitioner has a fear of the needles or limited dexterity.
Furthermore, the auto-injector should further be provided with safety to prevent accidental needle sticks from used needles due to the contamination hazards.
Therefore, the auto-injectors are alternative devices to a syringe for delivering a therapeutic agent.
In general, all auto-injectors capable to deliver the dose of medication, after the needle penetrate the patient's skin upon activation of the device if the auto-injector has protection from not proper of using the device by not trained patient.
The U.S. Pat. No. 8,992,476 describes the auto-injector comprise an additional cap to cover an activation button thus prevent accidental activation of the activation button during final assembly or transportation. After, remove the cap the patient has the ability for accidental activation the device and spills the medication.
Also, the injection device has a stepped shroud with two flexible arms for covering the needle of the syringe upon the injection was performed. Those flexible arms prevent the stepped shroud to slide back into a device as long as they do not get enough load to bend again and free the stepped shroud.
Moreover, the plunger has a rod portion with a compressible expanded central portion, named as the plunger elbows to move the syringe toward to injection side without injecting the medication prior to the elbows got compressed condition. This type of piston does not prevent the spill of the drug in case if one elbow of the plunger lost its stiffness or the mechanism has higher friction between parts.
However, a medical delivery device described above with all the presented flaws exist and there is still a possibility for improvements to make a current device more robust and secured.
The aim of the present invention is to remedy the drawbacks of the auto-injection device for injecting a substance, such as a therapeutic agent, into a patient. The purpose and advantages of the disclosed subject matter will be set and pointed out in the claims, as well as from the appended drawings.
According to the invention, the auto-injector consists of two main units: front unit and rear unit.
The front unit consists of a front housing containing the activator with the syringe holder which encloses the ejection spring keeping the activator protruded from the injection side of the front housing and the syringe holder both being arranged along a longitudinal axis under the influence the ejection spring. Furthermore, the front unit has a cover located on the injection end of the front unit to protect the activator.
The rear unit consists of the rear housing with the injection spring compressed via the controller withheld by the plunger arranged along a longitudinal axis into a locked position under the influence of the stopper. The stopper is not able to release the plunger because it is secured via the trigger button which prevents the accidental activation during transportation or assembly with the first unit. Moreover, the controller interacts with the syringe pusher which manages the movement of the syringe into the injection position upon activation of the auto-injector.
Finally, assemble the front and rear units together by installing the syringe, to exclude access to the syringe and protect the syringe from the damage. After the assembly, the activator and the stopper unite and have a coaxial motion, as one piece.
It is necessary to release the stopper in order to activate the auto-injector via the trigger button. For that, the trigger button must be rotated to a certain degree in order to free the stopper. When the assembly is done the auto-injector is ready to be packaged for delivery to the patient.
When the patient needs to administer medication, they should remove the cover of the auto-injector in conjunction with the shield which seals the needle of the syringe and provides access to the protruded activator located on the injection side of the device.
The trigger button may only be activated if the activator is pressed against the skin of the patient thereby shifting the activator with the stopper inside to release the plunger.
When the trigger button is pressed, the injection spring displaces the controller which in turn guides the plunger with the syringe pusher to the syringe, whereby the needle of the syringe penetrates the patient's skin. Only after that, the controller frees the syringe pusher and forwards the plunger to perform the administration of the drug into the body, thereby preventing the spill of the drug.
When the injection is completed, the patient withdraws the auto-injector from their skin, whereby the activator slides back protruded position by the ejection spring and permits the controller to slide forward. This allows the syringe holder with the syringe and the plunger to return back into the device by the ejection spring to a secure position.
Whereupon the controller slides between the activator and the syringe holder by the injection spring and prevent the syringe from sliding back to the injection position.
These and other aspects of and advantages with the present invention will become apparent from the following detailed description of embodiments of the invention and from the accompanying drawings.
The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus, are not limited of the present invention, and wherein:
The embodiment of the auto-injector according to the invention shown in
Referring initially to
For a better understanding look to
The front unit assembly 200 illustrated in
The front unit assembly 200 consists of the following components like the front housing 240, the activator 230 which positioned coaxially to the front housing with the ejection spring 220 and the syringe holder 210 from the one side respectively to the front housing 240 and the cap 250 from another side.
Referring to the
Initially, the activator 230 is coaxially inserted into the front housing 240 until stopped by stops 231 of the activator 230 touches the ribs 241 of the front housing 240 as shown in
After the ejection spring 220 is coaxially inserted into the activator 230 with the syringe holder 210 compressing the ejection spring 220 by the ribs 232 of the activator 230 illustrated in
Subsequent promotion of the syringe holder 210 inside the activator 230 leads to an interaction between the angled surface 212 of the syringe holder 210 shown in
For further advancement, the syringe holder 210 inside the activator requires a force to push the legs 213 of the syringe holder 210 illustrated in
The surfaces 214 of the syringe holder 210 illustrated in
Thereby the preloaded spring 220 is in the locked position between the syringe holder 210 and the activator 230, thereby preventing the activator 230 from sliding out from the front housing 240.
The next step is mounting the cap 250 to another side of the front housing 240. The inner cylindrical portion 251 of the cap 250 shown in
Further advancement of the cap 250, requires a force that can bend the legs 252 inwardly in order to pass over and snap behind the rib 243 of the front housing 240 demonstrated on
Therefore, the interaction between the front housing 240 and the cap 250 contributes to the retention of the parts together as illustrated in
At that moment the front unit is assembled.
The rear unit assembly 300 illustrated in
The rear unit assembly 300 consists of the following components like the rear housing 370, the stopper 360 with the trigger 350 positioned coaxially to the rear housing 370 from one side respectively and the injection spring 310, the controller 320 with the syringe pusher 330 and the plunger 340 from another side.
Referring to
Initially, install the injection spring 310 inside the rear housing 370. The injection spring 310 located coaxially between the internal ribs 371, 372 and 373 of the rear housing 370 indicated on
Whereupon, assemble the syringe pusher 330 with the plunger 340. To do this, insert the legs 341 of the plunger 340 illustrated on
The sidewalls 334 of the notches 331 presented in
Further advancement of the plunger 340 inside the syringe pusher 330 requires preliminary outward bending of the legs 332 of the syringe pusher 330 illustrated in
When the ribs 343 of the plunger 340 passed the clamps 333 of the legs 332 of the syringe pusher 330 must be released and returned to the original position to snap over the ribs 343 of the plunger 340 and secure the plunger 340 inside the syringe pusher 330 as shown in
Upon then, the plunger 340 with the syringe pusher 330 must be inserted together into the controller 320.
After the syringe pusher 330 with the plunger 340 is inserted into the inside of the controller 320, an interaction occurs between the syringe pusher 330 and the clamps 321 of the controller 320 shown in
For further advancement, the syringe pusher 330 inside the controller 320 requires enough force in order to bend legs 322 with the clamps 321 of the controller 320 outward and slide on the external cylindrical surface of the syringe pusher 330. The legs 322 with the clamps 321 shown in
Thereby occurs the return of the legs 322 of the controller 320 to resting condition and blocking the clamps 321 of the controller 320 between the shoulders 342 of the plunger 340 and surface 335 of the syringe pusher 330.
Also, the sidewalls 334 of the syringe pusher 330 interacts with the clamps 321 of the controller 320 to prevent rotation relative to each other.
Therefore, the plunger 340, the syringe pusher 330 and the controller 320 interact with each other and cannot be disassembled without changing the shape of the parts.
Thereafter following the insertion of the assembled the plunger 340 with syringe pusher 330 and controller 320 into the rear housing 370.
For this purpose, insert the syringe pusher 330 into the injection spring 310 until the surface 323 of the controller 320 shown in
Further advancement of controller 320 leads to compression of the injection spring 310 inside the rear housing 370 between ribs 371, 372 and 373 which ensure the correct positioning of the injection spring 310.
When the controller 320 enters inside the rear housing 370, it is necessary that the ribs 371 of the rear housing 370 pass through the grooves 324 of the controller 320 presented in
Subsequent movement of the controller 320 with the syringe pusher 330 and the plunger 340 followed by compression the injection spring 310 inside the rear housing 370 leads to an interaction between the angled surface 344 of the plunger 340 shown in
Thereby upon further movement, the legs 341 of the plunger 340 bends outwardly and locks 345 of the plunger 340 which crosses over the bridge 374 of the rear housing 370 and snap behind the bridge 374. Therefore, the plunger 340, the syringe pusher 330 and the controller 320 are locked at that position.
Likewise, the injection spring 310 remains in a compressed condition between the controller 320 and the rear housing 370, via plunger 340 as is presented in
To avoid spontaneous release of the injection spring 310 with the subsequent displacement of the plunger 340 is necessary to prevent the legs 341 of the plunger to bend outward and does not allow the locks 345 to slide from the bridge 374 of the rear housing 370. For that purpose, it is necessary to install the stopper 360 from the other side of the rear housing 370.
The legs 361 of the stopper 360 illustrated in
The subsequent traveling of the legs 361 of the stopper 360 passes inside cylindrical surface of the rear housing 370 where the ribs 373 of the rear housing 370 settle between legs 361 in gaps 362 of the stopper 360 shown in
With further progress, the stopper 360 into the rear housing 370, the locks 345 of the plunger 340 enters inside the hole 363 of the stopper 360 shown in
To maintain the position of the stopper 360 at that condition, you must install the trigger button 350 shown in
During installation, the trigger button 350 into the rear housing 370 the coaxial ribs 352 of the trigger button interact with the coaxial rib 377 of the rear housing 370 shown in
Also, the elongated parts 351 of the trigger button 350 have the cylindrical pockets 353 shown in
Therefore, the trigger button 350 located within the rear housing 370 thereby forbids change in position of the stopper 360, thereby, preventing the release of the locks 345 of the plunger 340, as shown in
When the front and rear units are ready, they are delivered for final assembly with the syringe assembly 400 presented in
Initially, install the syringe assembly 400 into the front housing 200. For that, the syringe assembly 400 slides through the syringe holder 210 and ejection spring 220 until the cover 404 has to contact with the cap 250.
Further advancement, the cover 404 of the syringe assembly 400 must be placed into the inner cylindrical portion 251 of the cap 250. Further advancement of the cover 404, requires a force that can ensure the outward bend the inclined cylindrical ribs 254 to increase internal diameter of the inner cylindrical portion 251 for receiving the cover 404 and return the inclined ribs 254 to rest position to catch the cover 404 after it fully inserted into the cap 250 as illustrated in
Therefore, the cap 250 of the front unit 200 keeps the syringe assembly 400 inside the front unit 200, thereby preventing the syringe assembly 400 accidentally sliding out from the front unit 200.
Thereafter, assemble the front unit 200 with the rear unit 300 by aligning the T-locks 234 of the activator 230 shown in
When the rear housing 370 enters into the front housing 240, the plunger 340 located in the rear unit 300 advances inside the syringe 402 which is located in the front unit 200.
The subsequent movement of the rear unit 300 into the front unit 200 leads to an interaction between the legs 361 of the stopper with the T-lock 234 of the activator 230. To further advance the rear unit 300 into the front unit 200, it is necessary to apply sufficient force to create an interaction between the surfaces 235 of the T-locks 234 shown in
Therefore, the legs 361 of the stopper 360 return to resting position, thereby the surfaces 365 of the stopper 360 have contact with surfaces 236 of the activator 230 and the surfaces 366 have contact with surfaces 237. Hence, the activator 230 and the stopper 360 are locked together and slides as one part inside the auto-injector 100.
Thereafter, when the auto-injector 100 is assembled the cylindrical ribs 379 of the rear housing 370 snap with the grooves 244 of the front housing 240 to prevent separation the front unit 200 with the rear unit 300, what is presented in
Before releasing the auto-injector to the patients is necessary to unlock the stopper 360 by turning the trigger button 350 by a certain degree. After that, the stopper 360 no longer interferes with the trigger button 350 as shown in
When a patient needs to inject medication, they should examine the auto-injector for medication through a window 245 of the front housing 240 presented in
During the inspection, it is impossible to activate the auto-injector spontaneously because the stopper 360 holds the locks 345 of the plunger 340 in the locked position on the bridge 374 as shown in
After inspection, the patient removes the cap 250 which has the incline ribs 254 engaged with the cover 404 of the syringe assembly 400. Also, the cover 404 joined with the needle sealer 403 by a notch 405 of the cover 404 and a ledge 407 of the needle sealer 403 respectively as illustrated in
Therefore, the cap 250 separates and pulls off the cover 404 with the needle sealer 403 from the auto-injector 100 and unseals the needle 406 as shown in
Then the patient shall press the auto-injector 100 to their body with enough force that displacement of the activator 230 inside the auto-injector 100 occurs which leads to the partial compression of the ejection spring 220 as illustrated in
As stated before, after the assembly of the front unit 200, with the rear unit 300, the activator 230, and the stopper 360 moves inside the auto-injector 100 to function as one part. Consequently, the activator 230 dislocates the stopper 360 which leads to the release of the locks 345 of the plunger 340 as presented in
After that, the patient needs to press the trigger button 350 to activate the auto-injector 100 in order to ensure the injection of medicine.
In the event when the patient presses the trigger button 350, a trapezoid portion 354 of the trigger button 350 comes in contact with the locks 345 of the plunger 340 and moves apart the locks 345 by bending the legs 341 of the plunger 340 as shown in
When the distance between locks 345 is bigger than the width of the bridge 374 of the rear housing 370, then the locks 345 shift into the windows 376 of the rear housing 370. See the
Occurring within the same time frame, the compressed injection spring 310 pushes the controller 320 which has the contact via the clamps 321 with the shoulders 342 of the plunger 340 as illustrated in
Therefore, the plunger 340 obtains freedom followed by displacement to the injection side and carrying the syringe pusher 330 which is connected by the clamps 333 with the ribs 343 of the plunger 340 as shown in
Thereupon, the controller 320, the plunger 340 and the syringe pusher 330 are released and now move as one.
The compressed injection spring 310 obtains a further extension and provides additional movement to the controller 320 towards the syringe side with the plunger 340 via the clamps 321 and the shoulder 342 accordingly as presented in
The plunger 340 also pushes the syringe pusher 330 via the ribs 343 and the clamps 333 accordingly as illustrated in
When the syringe pusher 330 travels to the injection side, it obtains contact with the syringe 402 which pushes the syringe 402 with the syringe holder 210 and compressing the ejection spring 220 as shown in
As was mentioned above the syringe 402 moves to the injection side whereby, the needle 406 moves out from the auto-injector 100 and penetrates the skin of the patient as presented in
The injection spring 310 extends more and continually pushes the controller 320 with the plunger 340 and the syringe pusher 330.
Also, the syringe pusher 330 shifts the syringe 402 with the syringe holder 210 and additionally compresses the ejection spring 220 until the lips 215 of the syringe holder 210 engage with the ribs 242 of the front housing 240 and stop the advancement of the syringe 402 as presented in
Simultaneously, the legs 325 of the controller 320 slip off from the ribs 373 of the rear housing 370 and are bent by the clamps 333 of the syringe pusher 330 which have a reaction from the ribs 343 of the plunger 340 which still continues move with the controller 320 by the injection spring 310 as shown in
Further expansion of the injection spring 310 drive the controller 320 and the plunger 340 to the injection side of the Auto-Injector 100 and separate the syringe pusher 330 from the plunger 340 as illustrated in
Contemporaneously, the plunger 340 travels inside fixed syringe 402 and got interaction with the piston 401 of the syringe assembly 400 as shown in
Subsequent expansion of the injection spring 310 shifts the controller 320 with the plunger 340 through interaction the clamps 321 with the shoulders 342 accordingly as presented in
The plunger 340 moves inside the stationary syringe 402 and pushes the piston 401 which creates pressure and pushes the medication through the needle 406 and delivering it into the patient's body.
When the plunger 340 moves inside the syringe 402, the controller 320 moves from the rear housing 370 into the activator 230.
While the plunger 340 moves the piston 401 down to a stop surface 408 inside the syringe 402 and finishes the delivery of the medication entirely as shown in
Therefore, the plunger 340 is still loaded by the injection spring 310 thus the controller 320 and keeps the syringe 402 in a fixed position due to the contact of the lips 215 of the syringe holder 210 with the ribs 242 of the front housing 240 as presented in
After all the medication has been administered to the patient, the patient moves the auto-injector 100 away from the body, as a result of which the activator 230 returns back towards the injection side by the pre-compressed ejection spring 220 until the stops 231 of the activator 230 adjoins with the ribs 241 of the front housing 240 as shown in
Since the activator has shifted relative to the controller, the protrusions 326 of the controller 320 are released by the activator 230 as shown in
This leads to an outward bending of the legs 322 of the controller 320 by the reaction between the clamps 321 of the controller 320 and the shoulders 342 of the pusher 340.
When the legs 322 are bent outward enough to allow clamps 321 of the controller 320 to slides off the shoulders 342 of the plunger 340 thereby breaking the connection between the controller 320 and the plunger 340.
After the plunger 340 loses the related force from the injection spring 310 it moves with the syringe holder 210 with the syringe 402 into the second unit 300 by means of the ejector spring 220 until the surfaces 214 of the syringe holder 210 adjoins to the ribs 242 of the front housing 240 as illustrated in
Then the plunger 340 with the syringe 402 and the syringe holder 210 moves into the second unit 300 allowing the clamps 321 of the controller 320 to shift inwardly between legs 213 of the syringe holder 210, snapping behind surface 216 as shown in
Furthermore, the controller 320 moves further by means of the injection spring 310 into the activator 230 until it links with the ribs 232 of the activator 230 keeping the activator 230 in an extended position as presented in
Moreover, when the controller 320 moves more to the injection side the protrusions 326 of the controller 320 regains contact with the activator 230.
Consequently, the clamps 321 of the controller 320 cannot move outward and will always have contact with the syringe holder 210 if the syringe holder 210 moves to the injection side of the Auto-Injector 100.
Therefore, the needle 406 of the syringe assembly 400 is not able to move close enough to the injection site as shown in
Through the window 245 of the front housing, the patient is visually able to see the piston 401 at the stop surface 408 of the syringe 402 which verifies that all medication was delivered.