The present invention is generally directed to medicament injectors and is more particularly directed to needleless injectors.
A great number of injectors have been developed for transdermally providing medicament doses. All of these devices require sufficient energy to propel a medicament through the dermal surface of a patient. Such energy may be provided through the use of mechanical leverage, springs, compressed gas, or electrical solenoids.
Injectors may be developed for single use or have a rechargeable medicament and energy storage system. All of these systems require sufficient force on a piston or the like to eject all of the medicament at a pressure sufficient for dermal penetration.
The present invention is directed to needleless injectors for transdermal delivery of a medicament using a piston/or bolt through an injection head by an energy source.
A needleless injector in accordance with the present invention generally includes a housing, casing, or barrel along with an injection head and a piston, mold, or cylinder for forcing a medicament through the injection head upon the release of actuating energy.
The present invention may be more clearly understood with reference to the appended drawings of which:
With reference to
An injection head 22 is disposed at the barrel distal end 16, which is in fluid communication with the bore 20 for the injection of a medicament therethrough.
A vial 26 is provided for containing a medicament, such as BOTOX®, with the vial being in fluid communication with the bore 20 near the barrel distal end 16. Preferably, the vial 26 is removably attached to the barrel 12.
A gas cartridge 30 is disposed at the barrel proximal end 14 and a bolt 32 is provided and disposed in the bore 20 for reciprocal movement therein from a first position closing the port 28 to a second position opening the port for release of medicament into the bore 20.
The bolt 32 is sized and fitted to provide sufficient seal between the bolt 32 and the bore 20 in order to draw medicament from the vial into the bore 20 upon movement of the bolt 32 from the first position to the second position and to force medicament through the injection head 22 upon movement of the bolt 32 from the second position to the first position, as will be hereinafter described in greater detail.
A cocking stud 34 is provided for enabling manual movement of the bolt 32 from the first and second position. In this cocking movement, medicament is drawn into the bore 20 between the bolt 32 and the injection head 22 through the port 28.
A hammer 40 is provided and disposed for reciprocal movement within the bore 20 between the barrel and the proximal and distal end 12, 14. A mainspring 42 is disposed between the bolt 32 and the hammer 40 for forcing the hammer forwardly toward the barrel distal end 16.
A sear 46 is provided for releasably holding the bolt 32 in the second position with the mainspring 42 compressed between the bolt 32 and the hammer 40 and a trigger 48 is disposed in an operative relationship with the sear 46 for releasing the spring 42 in order to drive the hammer 40 toward the barrel distal end 16.
A valve tube 52 is provided and disposed within the bore 20 with the distal thereof attached to the bolt 32 and a proximal end attached to the gas cartridge 30. The valve tube 52 extends through the hammer 40 and mainspring 42.
A cup seal 56 includes a valve seat 58 for controlling gas flow from the cartridge 30 into the valve tube 52.
In that regard, a rear spring 60 is provided for releasably sealing the cup seal 56 against the valve seat 58. The cup seal 56 is open momentarily by impact of the hammer 40 after release by the sear 46 in order to allow gas to flow through the valve tube 52 to force the bolt 32 to the first position which ejects medicament through the injection head 22. The rear spring 60 thereafter closes the cup seal 56 against the valve seat 58 after the momentary opening.
In operation, when the bolt 32 is not cocked, a forward portion blocks entry of the medicament into the bore 20 extending through the barrel 12. In order to cock the injector 10, the cocking stud 34 is moved rearwardly, pushing against the mainspring 42 in order that the bolt 32 butts up against the hammer 40. This motion opens the port 28 between the vial 26 and the bore 20 and draws medicament into the bore 20 between the injection head 22 and the bolt 32. The sear 46 catches the bolt 32 as the bolt 32 is pushed against the hammer 40 and this binds the bolt 32 and the hammer 40 together so they move as one unit.
For injecting a medicament, the trigger 48 is pushed in order to release the sear 46 which releases the hammer 40 from the bolt 32 and the mainspring 42 propels the hammer 40 rearwardly in order to push momentarily onto the valve tube 52 which propels the valve backward with sufficient force to overcome the rear spring 60. At that point, gas pressure is released from the gas cartridge 30 through the tube 52, which causes the bolt 32 to rapidly move and eject medicament disposed between the front of the bolt 32 and the injection head 22 through the injection head 22.
With reference to
A vial 128 is provided for containing a medicament, such as (BOTOX®), with the vial 128 being in fluid communication with the bore 120 through a port 130 near the barrel distal end 114. Preferably the vial 128 is removably attached to the barrel 112 which is in turn supported by a frame 134.
A cylinder 136 is rotatably supported by the frame 134 at the barrel proximal end 114 and includes a plurality of chambers 140 therein for receiving gas cartridges 142.
A bolt 144 is disposed in the bore 120 for reciprocating movement from a first position closing a port 130 as shown in
The bolt 144 is fitted within the bore 120 in order to draw medicament from the vial 128 through the port 130 via a line 148 upon movement of the bolt 144 from the first position to the second position. Movement of the bolt 144 from the second to the first position as hereinafter described forces a medicament through the injection head 124. The injection head may be of any conventional design.
A spring 152 is disposed adjacent to the bolt 144 for driving the bolt 144 from the first to the second position, as hereinafter described.
A firing pin 160 may be disposed between the bolt 144 and the cylinder 136 for puncturing a gas cartridge 142 aligned with a hammer 156 and bore 120 by rotation of the cylinder 136. A trigger 164 pivotally 166 mounted to the frame 134 utilizes a linkage 170 for forcing the aligned cartridge 142 with the hammer 156 for puncture of the cartridge 142 in order to pneumatically drive the bolt 144 from the second position to the first position and force medicament in the bore through the ejection head 124, as shown in
It should be appreciated that the cylinder 136 may be manually rotated to align bore 120 and hammer 156 or a pawl and ratchet arrangement may be provided in order to rotate the cylinder 136 prior to a movement of a gas cartridge 142 into engagement of the hammer for release of pressure therein.
With reference to
A top half shell 220 is hingeably attached to the casing rear end 214 for covering the bottom half shell 214.
A nose cap 222 is removably attached to a front end 226 of the tubular casing 212 and an injection head 230 is disposed in an end 232 of the nose cap 222. As more clearly shown in
A push rod is housed between the top half shell 220 and bottom half shell 214 is provided for slidably moving the plunger 242 and a spring 256 is disposed about a rear portion 260 of a push rod 250 for driving the push rod.
A ratchet 262 is disposed on a forward portion 264 of the push rod and manually operated trigger 270 which is pivotably mounted within the tubular casing 212 includes a button extending outwardly from the tubular casing 212 for manual depression of a link mechanism 274 and a sear 276 for releasably engaging a ratchet 262.
With reference to
The cylinder 316 is slidably disposed within the cocking ring 314 and includes a front end 342 and a rear end 344 with a chamber 346 disposed proximate the front end 342. A vial 350 for containing a medicament is replaceably disposed proximal end 332 and is in fluid communication with the chamber 346 through a dip tube 324 and check valve 324.
The injection head 318 is disposed at the cylinder front end 342 and in fluid communication with the chamber 346. The injection head may be of any suitable design.
A piston 364 is slidably disposed within the cocking ring 314 and includes a front head 366 slidably disposed within the cylinder 316 and a rear head 368 slidably disposed within the housing bore 334.
The front head 366 is fitted to the cylinder 316 in order to draw medicament from the vial 350 into the chamber through the one-way valve 324 upon movement of the piston 364 from a first position shown in
A main spring 372 is disposed between the housing proximal end 332 and the piston rear head 368 and a sear 380 is provided for releasably holding of the piston 364 in the second position with the main spring 372 compressed. The sear 380 includes a sear spring 382 and a tapered end 384 which provides releasable engagement with the piston rear head 368.
In use, the injector head 318 is pressed against the skin 360 which causes rearward motion of the cylinder 316 and the cylinder rear end 344 is urged against the tapered end 384 causing movement of the sear in the direction of the arrow 390 and compression of the sear spring 382 which releases the piston rear head 368 and piston 364, thus causing the spring 372 to force the piston front head 366 into the chamber 346 forcing medicament through the injection head 318, as indicated by the arrow 370.
To re-cock the device the cocking ring 314 is moved in the direction of the arrow 394, thus moving the piston end 384 and re-engagement of the sear 380 with the piston rear head 368.
As illustrated in
With reference to
As shown in
The injection head, which may be of conventional design, is disposed at the housing distal end 426 and is in fluid communication with the chamber 430.
The vial 416 may support a replaceable container 434 containing a medicament, not shown, as hereinabove referenced and is in fluid communication with the chamber through a dip tube 436 and a one-way valve 438.
A piston 440 is slidably disposed within the housing 412 and includes a piston head slidably disposed within the chamber 430 and a separately moveable stem 444 disposed in the housing 428. The piston head 442 is fitted within the chamber 430 in order to draw medicament from the vial 416 into the chamber 430 through the one-way valve 438 and dip tube 436 upon movement of the piston head from a first position, as shown in
Medicament is forced through the injection head 414 by movement of the piston head 442 from the second position, as shown in
As shown in
The trigger 422 is pivotally 476 disposed on a housing 412 and in an operational relationship with the sear 474 for releasing the spring 466 in order to drive the piston 442 along with fore plate 460 to the first position, thus ejecting a metered dose of medicament determined by the chamber 430 volume.
With reference to
As shown in
The injection head 514, which may be of conventional design, is disposed at the housing distal end 526 and is in fluid communication with the chamber 530.
The vial 516 may support a replaceable container 534 containing a medicament, not shown, as hereinabove referenced and is in fluid communication with the chamber through a dip tube 536 and a one-way valve 538, for example a duckbill valve.
A piston 540 is slidably disposed within the housing 512 and includes a piston head 542 slidably disposed within the chamber 530 and a moveable stem 544 disposed in the housing 512. The piston head 542 is fitted within the chamber 530 in order to draw medicament from the vial 516 into the chamber 530 through the one-way valve 538 and dip tube 536 upon movement of the piston head from a first position, as shown in
Medicament is forced through the injection head 514 by movement of the piston head 542 from the second position, as shown in
As shown in
The trigger 522 is pivotally 576 disposed on the housing 512 and in an operational relationship with the sear 574 for releasing the spring 566 in order to drive the piston 542 along with fore plate 560 to the first position, thus ejecting a metered dose of medicament determined by the chamber 530 volume.
With reference to
A drug manifold or line 630 communicates with the vial 626 through a dip tube 634 and a chamber 638 for transport of medicament from the vial 626 into the chamber 638. A one-way valve 642, such as, for example, a duckbill valve, disposed in the drug manifold 630 prevents transport of medicament into the vial from the chamber.
A piston 646 is provided and slidably disposed within the chamber for forcing medicament through the injection head 632 and withdrawing medicament from the vial 626 into the chamber 638 through the manifold. A gas manifold 650 is provided behind a proximal end 652 of the piston 646 for introducing gas from a line 654 behind the piston proximal end 652 in order to drive the piston 646 toward the casing distal end 618 thereby forcing medicament through the injection head 622.
In the embodiment 610, a cocking stud 656 may be provided in order to move the piston toward the casing proximal end 616 in order to withdraw medicament from the vial 626 and into the chamber 638 for subsequent injections.
With reference to
A manually operated gas valve 664, not shown, in
Operation of the injector 660 is illustrated in
With reference to
A plunger 744 includes a first end, or piston, 748 slidably disposed within the cylinder 722 for forcing medicament in the cylinder 722 through the injection head 726 upon movement of the plunger 744 toward the injection head 726 and for withdrawing medicament from the vial 734 into the cylinder 722 upon movement of the plunger 744 away from the injection head 726. As hereinafter described, the plunger 744 is operable, or moveable, through the application of a magnetic flied provided by a solenoid stack 752. The solenoid 752 is disposed around the plunger 744 between the first end 748 and a second end 756 of the plunger 744. The solenoid 752 is disposed in an operational manner for forcing the plunger 744 toward the injection head 726 upon application of electrical current controlled by a trigger switch 760 interconnected with a power supply such as, for example, a 110 volt AC line 764.
A spring 768 is disposed around the plunger 744 between the solenoid 752 and the second end 756 for forcing a plunger 744 away from the injection head 726 after electrical current is not applied to the solenoid 752 in order to withdraw medicament from the vial 734 into the cylinder 722 as hereinabove noted.
As more clearly shown in
Operation of the device is illustrated in
Upon energizing the solenoid 752 through the application of electrical current controlled by the trigger switch 760, the plunger 744 is forced to a distal end 776 of the cylinder 722 as shown in
After injection of medicament through the injector head 726, power is removed from the solenoid through the switch 760 enabling the spring 768 to force the plunger away from the injector head with the first end, or piston, 748 thereof withdrawing to the proximal end 772 of the cylinder 722.
Although there has been hereinabove described specific needleless injectors in accordance with the present invention for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. That is, the present invention may suitably comprise, consist of, or consist essentially of the recited elements. Further, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein. Accordingly, any and all modifications, variations or equivalent arrangements which may occur to those skilled in the art, should be considered to be within the scope of the present invention as defined in the appended claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US04/19491 | 6/17/2004 | WO | 11/14/2005 |
Number | Date | Country | |
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60480320 | Jun 2003 | US | |
60480784 | Jun 2003 | US | |
60480665 | Jun 2003 | US | |
60484069 | Jul 2003 | US | |
60491159 | Jul 2003 | US | |
60494463 | Aug 2003 | US | |
60497780 | Aug 2003 | US | |
60497992 | Aug 2003 | US |