CA2412420C - Wet/dry automatic injector assembly - Google Patents
Wet/dry automatic injector assembly Download PDFInfo
- Publication number
- CA2412420C CA2412420C CA002412420A CA2412420A CA2412420C CA 2412420 C CA2412420 C CA 2412420C CA 002412420 A CA002412420 A CA 002412420A CA 2412420 A CA2412420 A CA 2412420A CA 2412420 C CA2412420 C CA 2412420C
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- CA
- Canada
- Prior art keywords
- dry
- assembly
- medicament
- compartment
- liquid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/206—With automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3145—Filters incorporated in syringes
Abstract
The present invention is directed to an automatic injection device containing a pre-loaded charge of medicament for automatically self-administering the medicament upon actuation thereof. The automatic injection device includes a dry compartment located within a housing for storing a predetermined dry charge of the medicament therein, a wet compartment within the housing for storing a predetermined amount of liquid injection solution therein, an activation assembly for causing the liquid injection solution in the wet compartment to be transferred to the dry wet compartment, and at least one compression assembly for maintaining the medicament located in the dry compartment under a continuous compressive state as the liquid injection solution passes through the dry compartment.
Description
= WET/DRY AUTOMATIC INJECTOR ASSEMBLY
FIELD OF TuE IN'PENTION
The present invention relates to automatic injectors for delivering meditcament to an injection site. Tn particular, the present invention is directed to an automatic injector assembly for quickly combining a liquid material with a dry material to form a liquid medicament for deliveriag the medicament to an injection site.
BACKGROUND OF'I'EIL INVENTION
An automatic injector is a device for enabling an individual to self-administer a dosage of medicament i.nto bis or her flesh. The medicament is stored in liquid form. The advantage of automatic injectors is that they contain a measured dosage of a liquid medicam.ent in a sealed sterile car4ndge and can be utilized for delivering the medicaznent into the flesh during emergency situations. Another advantage of automatic injectors is that the self-administration of the medicament is accomplished without the user initially seeing the hypodermic needle tbrough which the medicament is delivered and without having the user to manually force the needle into his or her own flesh.
There are drawbacks associated with the storage ofinedicament in liquid form.
Some medicaments are not stable in liquid form. Furthermore, some liquid medicaments typically have a shorter shelf Iife than their solid counterparts.
Others have developed automatic injectors that store the medicament in solid form and a liquid injection solution. These injectors, disclosed for example in US
Reissue Patent No. 35,985, entitled "Multiple Chamber Automatic Injector.;
however, require the user of the injector to expedite dissolution of the solid component by manually shaking rhe liquid compone.nt and the solid component immediately prior to injection. Tbis increases the time needed to adminisEer a dose of inedicament. Furthermore, the improper mixing of the medicament with the liquid injection solution may release an insufftcient dose of medicament. There is a need for an automatic injector that stores medicament in solid form that does not require manual premixing by the user.
Furkhenmore, rapid delivery of the medicament is needed for emergency medical situations (e.g. nerve gas and chemical agent poisoning).
OBJECTS OF THE INVENTION
It is therefore an object of the present invention to provide an automatic injector device that stores medicament in a solid form for increased shelf life.
It is another object of the present invention to provide an automatic injector device that automatically mixes a solid medicament with a liquid injection solution upon activation.
It is another object of the present invention to provide an automatic injector device that stores the solid medicament under pressure to enhance dissolution in the liquid injection solution.
Additional objects and advantages of the invention are set forth, in part, in the description which follows, and, in part, will be apparent to one of ordinary skill in the art from the description and/or practice of the invention.
SUMMARY OF THE INVENTION
In response to the foregoing challenges, applicants have developed an innovative automatic injection device having both wet and dry storage compartments.
The present invention is directed to an automatic injection device containing a pre-loaded charge of medicament for automatically self-administering the medicament upon actuation thereof. The automatic injection device may include a housing asseinbly, a dry compartment located within the housing for storing a predetermined dry charge of the medicament therein, a wet compartment within the housing for storing a predetermined amount of liquid injection solution therein, and an activation assembly for causing the liquid injection solution in the wet compartment to be transferred to the dry compartment. In accordance with the present invention, the medicament located within the dry compartment dissolves in the liquid injection solution as the liquid injection solution passes through the dry compartment to the needle.
The automatic injector in accordance with the present invention further includes at least one compression assembly for maintaining the medicament located in the dry compartment under a continuous compressive state as the liquid injection
FIELD OF TuE IN'PENTION
The present invention relates to automatic injectors for delivering meditcament to an injection site. Tn particular, the present invention is directed to an automatic injector assembly for quickly combining a liquid material with a dry material to form a liquid medicament for deliveriag the medicament to an injection site.
BACKGROUND OF'I'EIL INVENTION
An automatic injector is a device for enabling an individual to self-administer a dosage of medicament i.nto bis or her flesh. The medicament is stored in liquid form. The advantage of automatic injectors is that they contain a measured dosage of a liquid medicam.ent in a sealed sterile car4ndge and can be utilized for delivering the medicaznent into the flesh during emergency situations. Another advantage of automatic injectors is that the self-administration of the medicament is accomplished without the user initially seeing the hypodermic needle tbrough which the medicament is delivered and without having the user to manually force the needle into his or her own flesh.
There are drawbacks associated with the storage ofinedicament in liquid form.
Some medicaments are not stable in liquid form. Furthermore, some liquid medicaments typically have a shorter shelf Iife than their solid counterparts.
Others have developed automatic injectors that store the medicament in solid form and a liquid injection solution. These injectors, disclosed for example in US
Reissue Patent No. 35,985, entitled "Multiple Chamber Automatic Injector.;
however, require the user of the injector to expedite dissolution of the solid component by manually shaking rhe liquid compone.nt and the solid component immediately prior to injection. Tbis increases the time needed to adminisEer a dose of inedicament. Furthermore, the improper mixing of the medicament with the liquid injection solution may release an insufftcient dose of medicament. There is a need for an automatic injector that stores medicament in solid form that does not require manual premixing by the user.
Furkhenmore, rapid delivery of the medicament is needed for emergency medical situations (e.g. nerve gas and chemical agent poisoning).
OBJECTS OF THE INVENTION
It is therefore an object of the present invention to provide an automatic injector device that stores medicament in a solid form for increased shelf life.
It is another object of the present invention to provide an automatic injector device that automatically mixes a solid medicament with a liquid injection solution upon activation.
It is another object of the present invention to provide an automatic injector device that stores the solid medicament under pressure to enhance dissolution in the liquid injection solution.
Additional objects and advantages of the invention are set forth, in part, in the description which follows, and, in part, will be apparent to one of ordinary skill in the art from the description and/or practice of the invention.
SUMMARY OF THE INVENTION
In response to the foregoing challenges, applicants have developed an innovative automatic injection device having both wet and dry storage compartments.
The present invention is directed to an automatic injection device containing a pre-loaded charge of medicament for automatically self-administering the medicament upon actuation thereof. The automatic injection device may include a housing asseinbly, a dry compartment located within the housing for storing a predetermined dry charge of the medicament therein, a wet compartment within the housing for storing a predetermined amount of liquid injection solution therein, and an activation assembly for causing the liquid injection solution in the wet compartment to be transferred to the dry compartment. In accordance with the present invention, the medicament located within the dry compartment dissolves in the liquid injection solution as the liquid injection solution passes through the dry compartment to the needle.
The automatic injector in accordance with the present invention further includes at least one compression assembly for maintaining the medicament located in the dry compartment under a continuous compressive state as the liquid injection
2 solution passes through the dry compartment. As such the undissolved medicament is maintained in a compressive state. In accordance with the present invention, the at least one compression assembly is located within the dry compartment. Each compression assembly may include an expandable assembly. The expandable assembly expands as the medicament located within the dry compartment dissolves within the liquid injection solution. The expandable assembly may include a spring assembly and at least one plate to apply pressure on the medicament within the dry compartment. The at least one plate permits the passage of the liquid injection solution therethrough.
The automatic injector in accordance with the present invention further includes a needle assembly for dispensing the liquid injection solution containing the medicament dissolved therein.
The automatic injector in accordance with the present invention may further include a releasable liquid barrier assembly located between the wet compartment and the dry compartment for selectively preventing passage of the liquid injection solution from the wet compartment to the dry compartment at predetennined conditions.
It is contemplated that the releasable liquid barrier asseinbly permits the passage of the liquid injection solution to the dry compartxnent in response to a predetermined liquid pressure build up within the wet compartment.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described in conjunction witli the following drawings in which like reference nuinerals designate like elements and wherein:
Fig. 1 is a cross-sectional side view of a wet/dry automatic injector assembly in accordance with the present invention;
Fig. 2 is a partial cross-sectional schematic view of the wet/dry automatic injector assembly of Fig. 1;
Fig. 3 is a partial cut-away view of the injection end of the wet/dry automatic injector assembly of Fig. 1; and
The automatic injector in accordance with the present invention further includes a needle assembly for dispensing the liquid injection solution containing the medicament dissolved therein.
The automatic injector in accordance with the present invention may further include a releasable liquid barrier assembly located between the wet compartment and the dry compartment for selectively preventing passage of the liquid injection solution from the wet compartment to the dry compartment at predetennined conditions.
It is contemplated that the releasable liquid barrier asseinbly permits the passage of the liquid injection solution to the dry compartxnent in response to a predetermined liquid pressure build up within the wet compartment.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described in conjunction witli the following drawings in which like reference nuinerals designate like elements and wherein:
Fig. 1 is a cross-sectional side view of a wet/dry automatic injector assembly in accordance with the present invention;
Fig. 2 is a partial cross-sectional schematic view of the wet/dry automatic injector assembly of Fig. 1;
Fig. 3 is a partial cut-away view of the injection end of the wet/dry automatic injector assembly of Fig. 1; and
3 Fig. 4 is a partial schematic view of a barrier layer assembly of the wet/dry automatic injector assembly according to another embodiment of the present invention.
DETAILED DESCRIPTION OF Tmg PR.EFE1tRED E1ViBOD1NiENTS
Referring now, more particularly to the figures, there is shown in Fig. 1 an automatic injector assembly 10. The present invention is described in connection with a push button type auto injector, whereby the user removes an end cap assembly and presses a button to trigger the injection process. The present invention, however, is not limited to push button type automatic injectors; rather, it is contemplated that the present invention may be incorporated into a nose activated auto inj ector, as described for example in U.S. Patent No. 5,658,259_ The automatic injector assembly 10 includes a generally hollow housing 110.
The housing 110 includes an injection insertion end 111 and an activation end 112, as shown in Fig. 1. An actuator assembly 120 extends from an opening 113 in the activation end 112 of the housing 110. The actuator assembly 120 is slidably received wit.hin the housing I 10. A removable end cap assembly 130 is releasably secured to the actuator assembly 120. When the end cap assembly 130 is secured to the actuator assembly 120, a side portion 131 of the end cap assembly 130 is adapted to abut the housing 110 to prevent movement of the actuator assembly 120 and unintentional injection of the medicament.
The actuator assembly 120 includes a push button actuator assembly 121 having a hollow interior. The end cap assembly 130 engages the push button actnator assembly 121. A collet 122 is located within the hollow interior of the push button actuator assembly 121. An inner tube 123 is also located within the hollow interior of the push button actuator assembly 121. The inner tube 123 is adapted to contact the collet 122, as shown in Figs. 1 and 2. An opposite end of the inner tube 123 may include an engagement nb 1231 that is adapted to be received within a complementary recess 1211 within the push button actuator assembly 121. A
drive assembly 124 is positioned within a space formed between the collet 122 and the inner tube 123.
DETAILED DESCRIPTION OF Tmg PR.EFE1tRED E1ViBOD1NiENTS
Referring now, more particularly to the figures, there is shown in Fig. 1 an automatic injector assembly 10. The present invention is described in connection with a push button type auto injector, whereby the user removes an end cap assembly and presses a button to trigger the injection process. The present invention, however, is not limited to push button type automatic injectors; rather, it is contemplated that the present invention may be incorporated into a nose activated auto inj ector, as described for example in U.S. Patent No. 5,658,259_ The automatic injector assembly 10 includes a generally hollow housing 110.
The housing 110 includes an injection insertion end 111 and an activation end 112, as shown in Fig. 1. An actuator assembly 120 extends from an opening 113 in the activation end 112 of the housing 110. The actuator assembly 120 is slidably received wit.hin the housing I 10. A removable end cap assembly 130 is releasably secured to the actuator assembly 120. When the end cap assembly 130 is secured to the actuator assembly 120, a side portion 131 of the end cap assembly 130 is adapted to abut the housing 110 to prevent movement of the actuator assembly 120 and unintentional injection of the medicament.
The actuator assembly 120 includes a push button actuator assembly 121 having a hollow interior. The end cap assembly 130 engages the push button actnator assembly 121. A collet 122 is located within the hollow interior of the push button actuator assembly 121. An inner tube 123 is also located within the hollow interior of the push button actuator assembly 121. The inner tube 123 is adapted to contact the collet 122, as shown in Figs. 1 and 2. An opposite end of the inner tube 123 may include an engagement nb 1231 that is adapted to be received within a complementary recess 1211 within the push button actuator assembly 121. A
drive assembly 124 is positioned within a space formed between the collet 122 and the inner tube 123.
4
5 PCT/US01/18558 The drive assembly 124 provides the necessary force when activated to operate the injector to inject the user with a necessary dosage of inedicament. It is contemplated that the drive assembly 124 may be a spring assembly, a compressed gas assembly or any other suitable energy storing device. When activated, the drive assembly 124 causes the collet 122 to move such that a needle assembly 140 extends from an opening in the injection end 111 of the housing 110. Movement of the collet 122 also causes mixing of the dry medicament with the liquid injection solution, described in greater detail below.
One end of the collet 122 extends into a wet container 1501ocated within the housing 110. A sealing assembly 1221 is secured to the end of the collet 122, as shown in Figs. 1 and 2. The sealing asseinbly 1221 is adapted to engage the side wall of the wet container 150 to prevent leakage of the contents (e.g. liquid injection solution) of the wet container 150 from the activation end 112 of the housing 110.
The sealing assembly 1221 is preferably formed from a material having low frictional properties such that the collet 122 and sealing assembly 1221 may easily slide within the wet container 150 when operated. Alternatively, the sealing assembly 1221 may be lubricated with silicon or other suitable non reactive lubricant. The movement of the collet 122 and the sealing assembly 1221 pressurizes the liquid located within the wet container 150. One end of the wet container 150 opposite the sealing assembly 1221 includes an aperture 151 therein. When pressurized by movement of the collet 122, the liquid exits the wet container 150 through the opening 151 to the dry container 160, which contains the dry medicament in solid form.
A liquid barrier assembly 170 is located adjacent the opening 151 to prevent the inadvertent passage of liquid from the wet container 150 to the dry container 160.
As shown, the liquid barrier assembly 170 includes a movable plunger assembly slidably received within the dry container 160. The plunger assembly engages the side wall of the dry container 160 such that liquid does not pass to the dry medicament contained within the dry container 160. As pressure within the wet container 150 increases, the plunger assembly 170 moves away from the opening 151.
The dry container 160 includes a recess 161 in a side wall. Liquid may pass from the wet container 150 to the dry container 160 when the plunger assembly 170 is received within the recess 161. The recess 161 allows liquid to flow around the plunger assembly 170 to the dry medicament located within the dry container 160.
The present invention is not limited to the above-described arrangement of the dry container 160 and the wet container 150; rather, other variations are considered to be well within the scope of the present invention. For example, the each of the containers 150 and 160 may the same diameter. Furthermore, a single compartment having a divider assembly may be provided to separate the liquid injector solution from the dry medicament.
The present invention is not limited to the above-described plunger assembly 170; rather, it is contemplated that other liquid barrier assemblies may be employed.
The liquid barrier assembly must also prevent vapor transmission between the wet container 150 and the dry container 160. For example, the plunger assembly may be replaced with a barrier layer. The barrier layer would distort and subsequently rupture upon a suffcient build up of pressure within the wet container 150. The barrier layer may be formed from any suitable non reactive impermeable material that could rupture at a predetermined pressure.
It is also contemplated that the barrier layer may be pierced by a piercing element located within the housing 110. For example, a piercing element may extend from the sealing assembly 1221 such that upon a predetermined movement of the collet 122, the piercing element pierces the barrier layer to permit the liquid to flow from the wet container 150 to the dry container 160. Alternatively, the liquid barrier assembly may include a piercing element 270 extending from a compression element 180, as shown in Fig. 4. As pressure within the wet container 150 increases the barrier layer 271 distorts. A puncture within the barrier layer 271 is created when the layer 271 contacts the piercing element 270. A retainer assembly 272 may be located between the barrier layer 271 and the compression element 180 such that a sufficient distance exists between the barrier layer 271 and the piercing element 270 to allow for a sufficient build up in pressure.
The dry container 160 will now be described in greater detail. A suitable medicament is located within the dry container 160. It is contemplated that the dry medicament may be in either powder or freeze-dried form. To aid in the mixture of
One end of the collet 122 extends into a wet container 1501ocated within the housing 110. A sealing assembly 1221 is secured to the end of the collet 122, as shown in Figs. 1 and 2. The sealing asseinbly 1221 is adapted to engage the side wall of the wet container 150 to prevent leakage of the contents (e.g. liquid injection solution) of the wet container 150 from the activation end 112 of the housing 110.
The sealing assembly 1221 is preferably formed from a material having low frictional properties such that the collet 122 and sealing assembly 1221 may easily slide within the wet container 150 when operated. Alternatively, the sealing assembly 1221 may be lubricated with silicon or other suitable non reactive lubricant. The movement of the collet 122 and the sealing assembly 1221 pressurizes the liquid located within the wet container 150. One end of the wet container 150 opposite the sealing assembly 1221 includes an aperture 151 therein. When pressurized by movement of the collet 122, the liquid exits the wet container 150 through the opening 151 to the dry container 160, which contains the dry medicament in solid form.
A liquid barrier assembly 170 is located adjacent the opening 151 to prevent the inadvertent passage of liquid from the wet container 150 to the dry container 160.
As shown, the liquid barrier assembly 170 includes a movable plunger assembly slidably received within the dry container 160. The plunger assembly engages the side wall of the dry container 160 such that liquid does not pass to the dry medicament contained within the dry container 160. As pressure within the wet container 150 increases, the plunger assembly 170 moves away from the opening 151.
The dry container 160 includes a recess 161 in a side wall. Liquid may pass from the wet container 150 to the dry container 160 when the plunger assembly 170 is received within the recess 161. The recess 161 allows liquid to flow around the plunger assembly 170 to the dry medicament located within the dry container 160.
The present invention is not limited to the above-described arrangement of the dry container 160 and the wet container 150; rather, other variations are considered to be well within the scope of the present invention. For example, the each of the containers 150 and 160 may the same diameter. Furthermore, a single compartment having a divider assembly may be provided to separate the liquid injector solution from the dry medicament.
The present invention is not limited to the above-described plunger assembly 170; rather, it is contemplated that other liquid barrier assemblies may be employed.
The liquid barrier assembly must also prevent vapor transmission between the wet container 150 and the dry container 160. For example, the plunger assembly may be replaced with a barrier layer. The barrier layer would distort and subsequently rupture upon a suffcient build up of pressure within the wet container 150. The barrier layer may be formed from any suitable non reactive impermeable material that could rupture at a predetermined pressure.
It is also contemplated that the barrier layer may be pierced by a piercing element located within the housing 110. For example, a piercing element may extend from the sealing assembly 1221 such that upon a predetermined movement of the collet 122, the piercing element pierces the barrier layer to permit the liquid to flow from the wet container 150 to the dry container 160. Alternatively, the liquid barrier assembly may include a piercing element 270 extending from a compression element 180, as shown in Fig. 4. As pressure within the wet container 150 increases the barrier layer 271 distorts. A puncture within the barrier layer 271 is created when the layer 271 contacts the piercing element 270. A retainer assembly 272 may be located between the barrier layer 271 and the compression element 180 such that a sufficient distance exists between the barrier layer 271 and the piercing element 270 to allow for a sufficient build up in pressure.
The dry container 160 will now be described in greater detail. A suitable medicament is located within the dry container 160. It is contemplated that the dry medicament may be in either powder or freeze-dried form. To aid in the mixture of
6 !WO 01/93925 PCTlUS01/18558 the dry medicament with the Iiqaad inj ection solution contained in the wet container 150, it is desirable that the medicament be maintained in a conapressed state while in the dry container 160. Maintaining the dry m.edicameint -under compression during to injection, accelerates the dissolution of the solid medicament into the liquid injection solutiou. Fnrthermore, tTais prevents the liquid injection solution enteximg the dry container 160 from forming cbannel,s witl3in the dry mec3icament, w]nch would impede dissolutiou of the medicament witbin the solutiom As such, liquid iujectiton solution containing less than the necessary dosage of medicament may be injected into the user. The compression element 180 prevents this phemomenon.
The compression element 180, illustrated in Fig_ 1, includes at least one assembly havmg the ability to expand to compensate for the dissolution of the meclicament wifhin dry comxpatknnent 160. The compression element 180 may include a s,pring assembly 181 sandwiched between a pair of liquid permeable plates 182 and 183 _ It is contemplated that any suitable spring assembly may be employed provided that the expansion of fhe spring assembly is capable of compensating for the dissolution of the medicament witb.in the dry compartment 160 such that uadissolved dry medicameat is maintained iu a compressed state. The spring assembly may be formed from a non-reaciive stamless steel matezial. Other materials having similar mo,ti z'eactive,pro,perties are considered to be well within the scope of the prese,nt invention. FnztlzernaorP, it is contemplated that the spring assembly may be coated wrth a suitable non reactive matenial iuncluding, but not limited to 7Ceflou@.
The embodiment of the present invention illustrated in Figs. I aud 2Mustz-ates a single compression element 180 located witlain the dry compartment 160. It, howeve.r, is cantemplated that add'ztional compression elements may be employed.
For example, the medicament located witbitt the dry compartanent 160 may be sandwiched between a pair of compression elements_ Each colnpression element may iaaclude the above descn'bed spring assembly and liquid permeable plates. An example of this arrangement is illustrated in Figs. 14 and 15 of U S. Patmt No_ 5,725,777 to Taylor, entitled "Reagent/Drug Cac[nidge.' ;
Tlae li.qu%d i.njection solution mixed with the medicament may then exit the dry comvartment 160 fhrough the needle assembly 140 opposite the wet cvmapattment
The compression element 180, illustrated in Fig_ 1, includes at least one assembly havmg the ability to expand to compensate for the dissolution of the meclicament wifhin dry comxpatknnent 160. The compression element 180 may include a s,pring assembly 181 sandwiched between a pair of liquid permeable plates 182 and 183 _ It is contemplated that any suitable spring assembly may be employed provided that the expansion of fhe spring assembly is capable of compensating for the dissolution of the medicament witb.in the dry compartment 160 such that uadissolved dry medicameat is maintained iu a compressed state. The spring assembly may be formed from a non-reaciive stamless steel matezial. Other materials having similar mo,ti z'eactive,pro,perties are considered to be well within the scope of the prese,nt invention. FnztlzernaorP, it is contemplated that the spring assembly may be coated wrth a suitable non reactive matenial iuncluding, but not limited to 7Ceflou@.
The embodiment of the present invention illustrated in Figs. I aud 2Mustz-ates a single compression element 180 located witlain the dry compartment 160. It, howeve.r, is cantemplated that add'ztional compression elements may be employed.
For example, the medicament located witbitt the dry compartanent 160 may be sandwiched between a pair of compression elements_ Each colnpression element may iaaclude the above descn'bed spring assembly and liquid permeable plates. An example of this arrangement is illustrated in Figs. 14 and 15 of U S. Patmt No_ 5,725,777 to Taylor, entitled "Reagent/Drug Cac[nidge.' ;
Tlae li.qu%d i.njection solution mixed with the medicament may then exit the dry comvartment 160 fhrough the needle assembly 140 opposite the wet cvmapattment
7 150. In the event that two compression elements are utilized, the liquid in.jection solution mixed with the medicament will pass through one of the compression elements to the needle assembly 140 prior to exiting tbrough the opening. A
filter assembly, not shown, may be located adjacent the needle assembly 140 to prevent any undissolved medicament from entering the needle assembly 140. Additionally, a liquid impermeable membrane, not shown, may be provided to prevent the undesired passage of liquid in the event the liquid inadvertently enters the dry compartment 160.
The membrane may be either be punctured by the injection assembly 140 or rupture upon the build up of a sufficient amount of pressure.
As discussed above, the movement of the collet 122 and drive assembly 124 causes the injection needle 141 of the injection assembly 140 to advance and protrude through the housing 110. The injection of the medicament can be pexfozmed with a simple operation. The user simply removes the end cap assembly 130, locates the injection end of the housing 110 ad.jacent the injection site and presses the push button actuator assembly 121. This operation automatically triggers the operation of the drive assembly 124 to advance the collet 122 causing the liquid injection solution located within the wet compartcnent 150 to enter the dry compartment 160. The dissolved medicament is then transmitted through the injection needle 141 to provide the user with the necessary dose of inedicarnent. The automatic injector in accordance with the present invention reduces the amount of time required to administer medicament compared to other wetldry injectors. The present invention eliminates the need for mixing by the user.
It will be apparent to those skilled in the art that various modifications and variations may be made without departing from the scope of the present in.ventaon, For example, it is contenaplated that a cover assembly, described for example in U.S.
Patent No. 5,295,965 ' nQa.y be secured to the injection end of the housing 110 after deployment of the medicament. Furthermore, the automatic injector may further include a nipple plunger assembly, as described for example in U.S. Patent No. 5,295,965;
Thus, it is intended that the present invention covers the modi.fications and variations oÃthe
filter assembly, not shown, may be located adjacent the needle assembly 140 to prevent any undissolved medicament from entering the needle assembly 140. Additionally, a liquid impermeable membrane, not shown, may be provided to prevent the undesired passage of liquid in the event the liquid inadvertently enters the dry compartment 160.
The membrane may be either be punctured by the injection assembly 140 or rupture upon the build up of a sufficient amount of pressure.
As discussed above, the movement of the collet 122 and drive assembly 124 causes the injection needle 141 of the injection assembly 140 to advance and protrude through the housing 110. The injection of the medicament can be pexfozmed with a simple operation. The user simply removes the end cap assembly 130, locates the injection end of the housing 110 ad.jacent the injection site and presses the push button actuator assembly 121. This operation automatically triggers the operation of the drive assembly 124 to advance the collet 122 causing the liquid injection solution located within the wet compartcnent 150 to enter the dry compartment 160. The dissolved medicament is then transmitted through the injection needle 141 to provide the user with the necessary dose of inedicarnent. The automatic injector in accordance with the present invention reduces the amount of time required to administer medicament compared to other wetldry injectors. The present invention eliminates the need for mixing by the user.
It will be apparent to those skilled in the art that various modifications and variations may be made without departing from the scope of the present in.ventaon, For example, it is contenaplated that a cover assembly, described for example in U.S.
Patent No. 5,295,965 ' nQa.y be secured to the injection end of the housing 110 after deployment of the medicament. Furthermore, the automatic injector may further include a nipple plunger assembly, as described for example in U.S. Patent No. 5,295,965;
Thus, it is intended that the present invention covers the modi.fications and variations oÃthe
8 invention, provided they come within the scope of the appended claims and their equivalents.
9
Claims (7)
1. An automatic injection device containing a pre-loaded charge of medicament for automatically self-administering the medicament upon actuation thereof, said automatic injection device comprising: a housing assembly; a dry compartment for storing a predetermined dry charge of dry medicament therein; a wet compartment for storing a predetermined amount of liquid injection solution therein; a pre-loaded activation assembly for causing the liquid injection solution in said wet compartment to be transferred to said dry compartment, wherein the pre-loaded activation assembly automatically supplies a driving force upon activation to transfer the liquid injection solution in the wet compartment to the dry compartment, wherein the dry medicament dissolves in the liquid injection solution as the liquid injection solution passes through said dry compartment; at least one dynamic spring compression assembly for maintaining the dry medicament located in said dry compartment under a continuous compressive state as the liquid injection solution passes through said dry compartment, wherein at least a portion of a compressive force acting on the dry medicament located in said dry compartment is provided by said at least one dynamic spring compression assembly; and a needle assembly for dispensing the liquid injection solution containing the medicament dissolved therein.
2. The automatic injection device according to Claim 1, wherein said at least one compression assembly is located within said dry compartment.
3. The automatic injection device according to Claim 1, wherein said at least one compression assembly includes an expandable assembly, wherein said expandable assembly expands as the medicament located within said dry compartment dissolves within the liquid injection solution.
4. The automatic injection device according to Claim 3, wherein said expandable assembly includes a spring assembly and at least one plate to apply pressure on the medicament within said dry compartment.
5. The automatic injection device according to Claim 4, wherein said at least one plate permits the passage of the liquid injection solution therethrough.
6. The automatic injection device according to Claim 1, further comprising a releasable liquid barrier assembly for selectively preventing passage of the liquid injection solution from said wet compartment to said dry compartment at predetermined conditions.
7. The automatic injection device according to Claim 6, wherein said releasable liquid barrier assembly permits the passage of the liquid injection solution to the dry compartment in response to a predetermined liquid pressure build up within said wet compartment.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US20997400P | 2000-06-08 | 2000-06-08 | |
US60/209,974 | 2000-06-08 | ||
PCT/US2001/018558 WO2001093925A2 (en) | 2000-06-08 | 2001-06-08 | Wet/dry automatic injector assembly |
Publications (2)
Publication Number | Publication Date |
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CA2412420A1 CA2412420A1 (en) | 2001-12-13 |
CA2412420C true CA2412420C (en) | 2008-12-02 |
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Application Number | Title | Priority Date | Filing Date |
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CA002412420A Expired - Fee Related CA2412420C (en) | 2000-06-08 | 2001-06-08 | Wet/dry automatic injector assembly |
Country Status (12)
Country | Link |
---|---|
US (1) | US6702778B2 (en) |
EP (1) | EP1292343B1 (en) |
JP (1) | JP2003534879A (en) |
KR (1) | KR100795503B1 (en) |
AT (1) | ATE339980T1 (en) |
AU (1) | AU2001275393A1 (en) |
CA (1) | CA2412420C (en) |
DE (1) | DE60123237T2 (en) |
DK (1) | DK1292343T3 (en) |
ES (1) | ES2269418T3 (en) |
IL (2) | IL153248A0 (en) |
WO (1) | WO2001093925A2 (en) |
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- 2001-06-08 AT AT01942099T patent/ATE339980T1/en not_active IP Right Cessation
- 2001-06-08 KR KR1020027016676A patent/KR100795503B1/en not_active IP Right Cessation
- 2001-06-08 EP EP01942099A patent/EP1292343B1/en not_active Expired - Lifetime
- 2001-06-08 US US09/876,255 patent/US6702778B2/en not_active Expired - Lifetime
- 2001-06-08 CA CA002412420A patent/CA2412420C/en not_active Expired - Fee Related
- 2001-06-08 IL IL15324801A patent/IL153248A0/en active IP Right Grant
- 2001-06-08 ES ES01942099T patent/ES2269418T3/en not_active Expired - Lifetime
- 2001-06-08 AU AU2001275393A patent/AU2001275393A1/en not_active Abandoned
- 2001-06-08 DK DK01942099T patent/DK1292343T3/en active
- 2001-06-08 DE DE60123237T patent/DE60123237T2/en not_active Expired - Lifetime
- 2001-06-08 JP JP2002501496A patent/JP2003534879A/en active Pending
- 2001-06-08 WO PCT/US2001/018558 patent/WO2001093925A2/en active IP Right Grant
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2002
- 2002-12-03 IL IL153248A patent/IL153248A/en not_active IP Right Cessation
Cited By (1)
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CN110464917A (en) * | 2013-03-15 | 2019-11-19 | 温德加普医疗股份有限公司 | Portable medication mixing and delivery system and method |
Also Published As
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CA2412420A1 (en) | 2001-12-13 |
EP1292343B1 (en) | 2006-09-20 |
WO2001093925A3 (en) | 2002-03-28 |
IL153248A0 (en) | 2003-07-06 |
KR20030017533A (en) | 2003-03-03 |
US20020016563A1 (en) | 2002-02-07 |
JP2003534879A (en) | 2003-11-25 |
ATE339980T1 (en) | 2006-10-15 |
US6702778B2 (en) | 2004-03-09 |
DK1292343T3 (en) | 2007-01-29 |
DE60123237T2 (en) | 2007-09-20 |
EP1292343A2 (en) | 2003-03-19 |
WO2001093925A2 (en) | 2001-12-13 |
IL153248A (en) | 2007-08-19 |
AU2001275393A1 (en) | 2001-12-17 |
DE60123237D1 (en) | 2006-11-02 |
ES2269418T3 (en) | 2007-04-01 |
KR100795503B1 (en) | 2008-01-16 |
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