AU783680B2

AU783680B2 - Injection device

Info

Publication number: AU783680B2
Application number: AU36441/01A
Authority: AU
Inventors: Thaddeus G. Minior; John P. Willis
Original assignee: Biovalve Technologies Inc
Current assignee: Valeritas Inc
Priority date: 2000-01-07
Filing date: 2001-01-04
Publication date: 2005-11-24
Anticipated expiration: 2021-01-04
Also published as: AU3644101A; AU2006200790B2; AU2006200790A1

Description

7.Oct. 20 05 11 02 Sheiston IP No. 9223 P. 4 INJECTION DEVICE

BACKGROUJND

The invention relates to injection device injection devices including a needleless syringe), as well as components that can be used in injection devices.

Injection devices can be used for fluid injection into a body. Some injection devices can include a needleless syringe.

SUMMYARY

According to a first aspect the present invention provides an injection device, comprising: a housing having a proximal end and a distal end, the housing having a distal opening, and a first opening in a side of the housing between the proximal and distal ends; a propellant disposed inside the housing and spaced from the distal end; *a piston having a first cavity disposed inside the housing between the distal end 15 and the propellant; and a hollow sleeve configured to mate with the piston, the sleeve having a second cavity.

9 According to a second aspect, the present invention provides an injection device, comprising: a housing having a proximal end and a distal end, the housing defining a distal opeing, and a first opening in a side of the housing and between the proximal and distal ends; a propellant disposed inside the housing and spaced from the dista end; a sleeve disposed inside the housing and between the distal end and the propellant, the sleeve defiing a second opening and a first cavity, the second opening and the first cavity in fluid communication with the propellant; and a piston inateable with the sleeve and movable in a distal direction, the piston defining a third opening aligaable with the second opening, wherein the propellant is in fluid communication with the first opening when the second and third openings are aligned.

Unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', and the like are to be construed in an COMS ID No: SBMI-01685688 Received by IP Australia: Time (I-tm) 11:06 Date 2005-10-07 7. Oct. 2005 11:03 Shelston IP No 9223 P. -lainclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

The invention provides one or more components a gas generant unit and/or a housing unit) that can be used in an injection device an injection device including a needleless syringe), and injection devices containing one or more of these components.

The components can be removable, replaceable and/or adaptable to fit different sized injection devices. The injection devices can be re-usable. The injection devices can be in any of a variety of shapes and sizes.

For embodiments in which the injection device includes a gas generant unit, the gas generant unit can be removed before or after use of the injection device. Moreover, a gas generant unit that is removed from the syringe can be replaced with a different gas generant unit, which may contain the same or different gas generant compounds.

Furthermore, a gas generant unit can be adaptable to fit different sized injection devices.

Advantages associated with an injection device that is capable of using such a gas generant can include re-usability, relatively low cost to manufacture, relatively low cost "to use, and/or enhanced flexibility in materials used as gas generant and/or injection fluid.

The injection device can include a housing that allows a fluid a gas, such as a product of the reaction of the gas generant) to travel between the interior of the injection device and the exterior of the injection device without passing through the distal end of the injection device the exit port of a syringe, such as a needleless syringe, contained within the injection device). In certain embodiments, this feature can be provided, for example, by including the following components in the housing: a sliding piston, a sleeve (which can have one or more venting mechanisms, such as COMS ID No: SBMI-01685686 Received by IP Australia: Time 11:06 Date 2005-10-07 WO 01/51109 PCTIUSOI/00346 one or more venting grooves, annular venting groove(s)), and one or more pressure relief mechanisms one or more pressure relief holes). In these embodiments, the sliding piston can be designed to move along the sleeve so that, at one or more points along the path of motion of the sliding piston, the pressure relief mechanism(s) of the sliding piston align partially align or fully align) with the pressure relief mechanism(s) in the sleeve. When this occurs, the fluid reactant gas) can pass between the respective relief mechanism(s). The fluid reactant gas) then exits the injection device via a passageway that does not include the distal end of the injection device the exit port of a syringe, such as a needleless syringe, contained within the injection device).

In one aspect, the invention features an injection device, such as a needleless injection device, having a housing having a proximal end and a distal end, the housing defining a distal opening, and a first opening in a side of the housing and between the proximal and distal ends; a propellant disposed inside the housing and spaced from the distal end; and a movable member disposed inside the housing and between the distal end and the propellant, wherein the propellant is in fluid communication with the movable member and the first opening.

Embodiments include one or more of the following features.

The propellant is capable of forming a gas capable of moving the movable member in a distal direction and flowing through the first opening to the exterior of the housing.

The movable member comprises a piston defining a cavity, and the propellant is in fluid communication with the cavity. The movable member further defines a second opening in fluid communication with the first opening.

The device further includes a hollow sleeve configured to mate with the piston, the sleeve defining a second cavity in fluid communication with the propellant.

The sleeve further defines a third opening alignable with the second opening. The sleeve further defines a groove, and the third opening is disposed in the groove.

The device further includes a button at the proximal end of the housing; a battery inside the housing and adjacent to the button; electrical leads in electrical communication with the battery; and a wire in electrical communication with the electrical leads, the wire configured to trigger the propellant.

-2- WO 01/51109 pCT/US01/00346 The distal opening of the housing is configured to mate with a proximal end of a syringe. The syringe includes a plunger, and the movable member is configured to move the plunger in a distal direction.

The propellant includes a chemical pyrotechnic material.

The housing is composed of a plurality of detachable housings.

In another aspect, the invention features an injection device, such as a needleless injection device, having a housing having a proximal end and a distal end, the housing defining a distal opening, and a first opening in a side of the housing and between the proximal and distal ends; a propellant disposed inside the housing and spaced from the distal end; a sleeve disposed inside the housing and between the distal end and the propellant, the sleeve defining a second opening and a first cavity, the second opening and the first cavity in fluid communication with the propellant; and a piston mateable with the sleeve and movable in a distal direction, the piston defining a third opening alignable with the second opening, wherein the propellant is in fluid communication with the first opening when the second and third openings are aligned.

Embodiments include one or more of the following features.

The propellant is capable of forming a gas capable of flowing through the first cavity to move the piston, wherein the gas flows through the second and third openings when aligned, and through the first opening. The propellant includes a chemical pyrotechnic material.

The piston is coaxial with the sleeve and slidable over the sleeve to align the second and third openings. The piston defines a plurality of openings alignable with the second opening.

The sleeve defines a groove, such as an annular groove, the second opening disposed in the groove.

The distal opening of the housing is configured to mate with a syringe having a plunger, and the piston is configured to move the plunger.

-3- WO 01/51109 PCTIUS01/00346 The housing further defines an elongate passageway between the first opening and the third opening.

The device further includes a filter between the propellant and the first cavity.

The housing is composed of a plurality of detachable housings.

In another aspect, the invention features an apparatus that includes a housing, a button connected to the housing, a battery adjacent the button and connected to the housing, electrical leads in electrical communication with the battery, and a wire in electrical communication with the electrical leads.

In another aspect, the invention features an apparatus that includes a sleeve having a surface having at least one hole, a movable piston having at least one hole and a surface adjacent the surface of the sleeve, and a first housing connected to the sleeve and the movable piston.

In a further aspect, the invention features an injection device including first, second, third and fourth housings. The first housing is demountably attached to the second housing. The second housing is demountably attached to the third housing.

The third housing is demountably attached to the fourth housing. The first housing includes a button and a battery adjacent the button. The second housing includes an inner housing, electrical contacts within the inner housing, a wire within the inner housing and in electrical communication with the electrical contacts, and a gas generant within the inner housing. The third housing includes a syringe adaptor housing having an outer vent sleeve, a movable piston having an end and at least one relief hole, a fixed sleeve having a groove with a hole a pressure relief hole), the fixed sleeve being adjacent the movable piston, a drive piston having at least one groove, the drive piston being adjacent the end of the movable piston and a sealing device within the groove of the drive piston. The fourth housing includes a plunger having an end, a syringe adjacent the end of the plunger, and an elastomeric spring adjacent the syringe.

Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

-4- V I WO 01/51109 PCT/US01/0034 6 DESCRIPTION OF DRAWINGS Fig. 1 is a cross-sectional view of an embodiment of an injection device; Fig. 2 is a partial cross-sectional view of an embodiment of a portion of an injection device; and Fig. 3 is a partial cross-sectional view of an embodiment of a portion of an injection device.

DETAILED DESCRIPTION The invention relates to injection devices injection devices containing needleless syringes) and components that can be used in such injection devices.

Advantages of the injection devices can include that they are relatively safe to use, relatively less painful to use, capable of delivering fluid in a predetermined and/or desirable manner, and/or re-usable.

Fig. 1 shows a cross-sectional view of an embodiment of an injection device Device 5 includes housings 10, 20, 30 and 200. Housing 10 is demountably attached to housing 20 at section 250 by, for example, screw threads or a bayonet lock.

Housing 20 is demountably attached to housing 30 at section 260 by, for example, screw threads or a bayonet lock. Housing 30 is permanently attached to a bayonet interlock syringe housing adaptor 200 to provide a mechanism for fitting a syringe configuration.

Housing 10 includes a button 40, a battery 50, and an electrically insulative nonmetallic) cup 620 (Fig. 3).

Housing 20 encloses a housing 80 a disposable housing) having electrical contacts 60, a wire 70 and a propellant 90, such as a gas generant (Fig. 2).

Housing 30 includes a syringe adaptor housing 200 having an outer vent sleeve 150, a sliding piston 100 having pressure relief holes 130, sleeve 110 a fixed sleeve) having a groove 120 an annular groove), and a drive piston 170 having grooves containing sealing devices 180 o-rings) and a syringe interface 190 a custom syringe interface) located at its distal end (Fig. 3).

In some embodiments, assembly 30 is assembled as follows. Sleeve 110 is permanently attached to housing 30, followed by permanently attached outer vent sleeve 150 to the flange of sleeve 1 10. Then, elastomeric spring 210 is bonded to the 0 f WO 01/51109 PCT/US01/00346 end of housing 30, and syringe adaptor 200 is subsequently permanently attached to housing Syringe adaptor 200 an interlock adaptor) accepts a syringe housing 220 with its associated plunger 230.

Fig. 2 shows an exploded view of an embodiment of housing 80 including electrical contacts 60, wire 70, propellant 90, screen 240, filter 250 and cap 260 with an exit hole 270.

Fig. 3 shows an exploded view of an embodiment of sleeve 1 10, annular groove 120 having hole(s) 300, sliding piston 100 and vent holes 130.

During operation of injection device 5, button 40 a molded plastic button) is pressed, compressing a wave spring 610 which causes battery 50 a replaceable battery) to come into contact with electrical contacts 60. This causes an electrical current to pass through wire 70 a metal wire such as nickel/chromium wire, and/or a wire having a diameter of from about 0.005 inch to about 0.010 inch, such as about 0.010 inch), thereby heating wire 70 causing wire 70 to become red hot in about one second). The heat generated by wire 70 is sufficient to cause the reaction of chemical components contained in propellant 90. Such chemical components can include a fuel and an oxidant. A nonlimiting, illustrative list of examples of chemical components that can be used in propellant 90 a gas generant) are disclosed in U.S. Patent Nos. 4,103,684; 4,342,310; 4,447,225; 4,518,385; 4,592,742; 4,623,332; 4,680,027; 4,722,728; 4,913,699; 5,024,656; 5,049,125; 5,064,123; 5,190,523; 5,304,128; 5,312,335; 5,334,144; 5,383,851; 5,399,163; 5,499,972; 5,501,666; 5,503,628; 5,520,639; 5,569,189; 5,630,796; 5,704,911; 5,730,723; 5,840,061; 5,851,198; 5,879,327; 5,899,879; 5,899,880; 5,911,703; and 5,993,412, each of which is hereby incorporated by reference. Other chemical components are described in commonly-assigned Application No.

60/250,573, filed November 30, 2000, and entitled "Injection Devices", hereby incorporated by reference.

The gas formed by the reaction of the chemical components in propellant passes through screen 240 metal screen, such as a stainless steel screen of, for example, about 50 to 200 mesh) and filter 250 a glass fiber filter). Screen 240

A

WO 01/51109 PCT/US01/00346 can cool the reactant gas and/or trap slag, and filter 250 can trap particulates small particulates, such as those generated during the reaction).

After passing through filter 250, the reactant gases cause sliding piston 100 to move along the surface of sleeve 110. As piston 100 moves along the surface of sleeve 110, piston 100 urges drive piston 170 to push against plunger 230 which, in turn, pushes against fluid within syringe 220, thereby ejecting fluid from syringe 220 via outlet 310.

The movement of piston 100 along the surface of sleeve 110 also causes holes 130 to reach ring 120. When this occurs, the reactant gas can pass through one or more holes 300 one, two, three or four holes) in ring 120 and one or more of holes 130. The reactant gas that passes through holes 300 and hole(s) 130 can flow through relief channels 140, into space 160 an open space, or a space containing a filter material, such as glass wool) and out device 5 via gas vent 7.

The number, size and location of holes 130 can vary to assist in controlling the pressure of fluid exiting through distal end 310 of syringe 5. The location of holes 130 can be determined by interfacing the end of the syringe to a pressure transducer that in turn is interfaced to a real time data acquisition system. One example is a model PCI-730/6040E data acquisition board (commercially available from National Instruments of Austin, TX), which can be interfaced to a computer a personal computer) for real time pressure transducer measurements. Changes in the pressure profile due to changes in the placement, shape and size of holes 130 can be monitored and optimized accordingly.

The use of annular groove 120 can obviate the need for a precise alignment of holes 130 because holes 130 are not required to be keyed to contact groove 120.

Syringe 220 and plunger 230 can take on a variety of shapes and sizes. For example, syringe 220 and plunger 230 can be commercially available components such as available from Bioject Medical, located in Portland, OR; Injet Medical Products, Inc., located in Lake Forest, IL; and Avant Drug Delivery Systems, Inc., located in San Diego, CA).

The end of housing 30, syringe adaptor 200 and elastomeric spring 210 form an interlock, which, in certain embodiments, can be designed to accept the attachment of a WO 01/51109 PCT/US01/00346 commercially available syringes and/or ampules. The interlock may be one of several types including a bayonet type.

In certain embodiments, housing 80 is replaceable. In these embodiments, after an injection housing 80 can be removed and replaced with a different housing, and device 5 can be re-used.

The invention is not limited by the above description, and the invention contemplates variations and modifications to this description. For example, in some embodiments, housings 10, 20, 30 and/or 300 can be non-demountable.

In some embodiments, the invention provides for the delivery of a mixture of two substances.

The first substance can be a dry substance, a lyophilized protein, nucleic acid, RNA or DNA, or polysaccharide. The first substance can be a vaccine, or a drug. The first substance can be a peptide, polypeptide, or protein, an antibody, an enzyme, a hormone or growth factor. Preferred first substances include insulin.

The first substance can be: a blood protein, clotting factor VIII or a IX, complement factor or component; a hormone, insulin, growth hormone, thyroid hormone, a catecholamine, a gonadotrophin, PMSG, a trophic hormone, prolactin, oxytocin, dopamine and the like; a growth factor, EGF, PDGF, NGF, IGF's and the like; a cytokine, an, interleukin, CSF, GMCSF, TNF, TGF-alpha, TGF-beta.

and the 25 like; an enzyme, tissue plasminogen activator, streptokinase, cholesterol biosynthetic or degradative, glycosolases, and the like; a binding protein, a steroid binding protein, a growth hormone or growth factor binding protein and the like; an immune system protein, an antibody, SLA or MHC gene or gene product; an antigen, a bacterial, parasitic, or viral, substance or generally allergens and the like.

The second substance can be a liquid, a diluent or solute. Such liquids can include buffers, inert fillers, pharmaceutically acceptable carriers, or the like.

The subject can be a human or an animal, a laboratory animal, or pet, e.g., a dog or cat, or other animal, a bovine, a swine, a goat, or a horse. The first and second substance can be combined by the subject, or by another person.

Other embodiments are in the claims.

What is claimed is:

Claims

7. Oct. 2005 11:03 Sheiston IP No. 9223 P. 6 T1HE CLAIMS DERiNING THE MNENTION ARE AS FOLLOWS:- 1. An injection device, comprising: a housing having a proximal end and a distal end, the housing having a distal opening, and a first opening in a side of the housing between the proximal and distal ends; a propellant disposed inside the housing and spaced from the distal end, a piston having a first ravity disposed inside the housing between the distal end and the propellant; and a hollow sleeve configured to mate with the piston, the sleeve having a second cavity. 2. The device of claim 1, wherein the propellant is capable of forming a gas capable of moving the piston in a distal direction and flowing through the first opening to the exterior of the housing. 3. The device of claimn I or claim 2, wherein the sleeve further has a third opening alignable with the second opening. The device of claim 3, wherein the sleeve fuirther has a groove, and the third opening is disposed in the groove. 5. The device of any one of claims I to 4, further comprising a button at the proximal end of the housing; a battery inside the housing and adjacent to the button; electrical leads in electrical communication with the battery; and a wire in electrical communication with the electrical leads, the wire configured to trigger the propellant. 6. The device of any one of claims 1 to 5, wherein the distal opening of the housing is configured to mate with a proximnal end of a syringe. 7. -The device of claim 6, wherein the syringe comprises a plunger, and the piston is configured to move the plunger in a distal direction.
8. The device of any one of claims I to 7, wherein the propellant comprises a chemical pyrotechnic material.
9. The device of any one of claims 1 to 8, wherein the housing is composed of a plurality of detachable housings. COMS ID No: SBMI-01685686 Received by IP Australia: Time 11:06 Date 2005-10-07 7. Oct. 2 0 05 11 03 Sheiston IP No. 9226 P. .7 The device of any one of claims Ito 9, wherein the device is needleless injection device.
11.- An injection device, comprising: a housing having a proximal end and a distal end, the housing defining a distal opening, and a first opening in a side of the housing and between the proximal and distal ends; a propellant disposed inside the housing and spaced fronm the distal end; a sleeve disposed inside the housing and between the distal end and the propellant, the sleeve defining a second opening and a first cavity, the second opening and the first cavity in fluid communication with the propellant; and a piston mateable with the sleeve and movable in a distal direction, the piston defining a third opening alignable with the second opening, wherein the propellant is in fluid communication with the first opening when the second and third openings are aligned.
12. The device of claim 11, wherein the propellant is capable of forming a gas capable *of flowing through the first cavity to move the piston, wherein the gas flows through the second and third openings when aligned, and through the first opening.
13. The device of claim 11 or claim 12, wherein the piston is coaxial with the sleeve and slidable over the sleeve to align the second and third openings.
14. The device of any one of claims 11 to 13, wherein the piston has aplurality of openings alignable with the second opening. The device of any one of claims 11I to 14, wherein the sleeve defines a groove, the second opening disposed in the groove.
16. The device of claim 15, wherein the groove is annular.
17. The device of any one of claims 11I to 16, wherein the distal opening of the housing is configured to mate with a syringe comprising a plunger, and the piston is configured to move the plunger.
18. The device of any one of claims 11 to 17, futher comprising a button at the proximal end of the housing; a battery inside the housing and adjacent to the button; electrical leads in electrical communication with the battery; and a wire in electrical communication with the electrical leads, the wire configured to trigger the propellant. COMS ID No: SBMI-01685686 Received by IP Australia: Time 11.08 Date 2005-10-07 7. Oct. 2005 11:04 Shelston IP No. 9228 P. 8 -11
19. The device of any one of claims 11 to 18, wherein the housing further defines an elongate passageway between the first opening and the third opening. The device of any one of claims 11 to 19, wherein the propellant comprises a chemical pyrotechnic material.
21. The device of claim 20, further comprising a filter between the propellant and the first cavity.
22. The device of any one of claims 11 to 21, wherein the housing is composed of a plurality of detachable housings.
23. The device of any one of claims 11 to 22, wherein the device is a needleless injection 0o device.
24. An injection device, substantially as herein described with reference to any one of the examples and/or drawings but excluding comparative examples. DATED this 7 t 1 day of October 2005 Shelston IP 15 Attorneys for: Biovahve Technologies, Inc. *o o o* q o*oo *oo*o COMS ID No: SBMI-01685686 Received by IP Australia: Time 11:06 Date 2005-10-07