TWI574707B - Syringe devices and syringe piston - Google Patents

Description

Injection device and injection piston

Embodiments of the invention relate to an injection device, an injection piston configuration, a pharmaceutical preparation system, and a method of preparing a medicament.

The preparation of a medicament or medicament and the application of such agents to a person typically involve mixing two or more components to form a dose and then delivering the mixed medicament to an individual. Mixing the components typically involves extracting one portion from a bottle or other container in fluid form and transferring the components to a separate container containing the other component. In certain instances, only a portion of the contents of a bottle or container is to be used to prepare a mixture prior to application. Thus, extraction and transfer can involve accurately measuring one or more components to be mixed.

A variety of problems can occur when using conventional methods and devices to mix drugs and/or to administer drugs to individuals. For example, in the case where multiple components are to be mixed, extracting and transferring one component and introducing the component into another component may potentially expose one or both of the components to a result of contamination. Non-sterile or contaminated environment of the drug. In addition, incomplete extraction or incorrect measurement of one or more components can result in the preparation and/or application of an incorrect dose. In certain cases, once a drug is mixed, the mixture must be again extracted from a vial or container into a syringe before the individual is applied. This additional transfer can result in additional contamination of the contamination, incomplete extraction of the contents, and/or inaccurate measurement of a portion or resulting drug.

In practice, there is limited availability for maintaining a sterile sterile environment during transfer and/or mixing of components or during preparation and transfer of a drug. Additional errors can be made using the wrong diluent Produced by reconstituting the drug. Finally, the use of multiple components to prepare a drug may be slow due to factors such as the need to access individually packaged articles and/or transfer devices such as separate vials, or to measure factors to be combined to form one or more components of the drug. time consuming.

Alternative methods and systems for preparing and administering drugs will need to be developed.

In one aspect, the invention comprises an injection device. The device includes a syringe and a piston having a first end insertable into the syringe. One of the second ends of the piston is opposite the first end and the piston has a total length defined between the first end and the second end. A bottle opening is disposed within the piston and is configured to receive a bottle in a longitudinal direction along a portion of the total length of the piston. A fluid aisle extends from the mouth of the bottle through the first end of the piston through the piston.

In one aspect, the invention comprises an injection piston having a stem portion that includes one or more projections. A sealing portion is overmolded onto the stem portion and covers one or more projections.

In another aspect, the invention comprises an injection device having a syringe and an injection piston, the injection piston having a first end insertable into the syringe and a second end opposite the first end. A bottle outer casing is associated with the second end of the piston and extends from the second end of the piston. A piercing structure is associated with the second end of the piston and extends into the bottle housing.

In one aspect, the invention comprises an injection device comprising a syringe, a piston cannula and a cannula insert. The cannula insert has a first end insertable into the sleeve and an opposite second end. The cannula insert has a length defined by the distance between the first end and the second end. A fluid passage extends at least a portion of the length of the cannula insert from the first end along an outer side of the cannula insert. A rotary valve controls fluid communication between the fluid passage and the syringe.

In one aspect, the invention comprises an injection device having a syringe and a piston sleeve having a cannula insert having a first end insertable within the cannula And an opposite second end, the length of one of the sleeve inserts is first The distance between the end and the second end is defined. A compartment is disposed within the cannula insert and a valve controls fluid communication between the compartment and the syringe.

In another aspect, the invention comprises a pharmaceutical preparation system. The system includes a syringe having a syringe having an internal chamber, a piston having a first end, a second end, and a fluid passageway through the piston, at least a portion of the piston A first end inserted into the chamber is included. A valve is associated with the fluid aisle and includes a valve body and a cover overmolded onto the valve body.

The invention further comprises a method of preparing a medicament for administering an individual. A syringe is provided having a syringe and a piston disposed at an initial position relative to the syringe. The piston has a piston sleeve and a sleeve insert. A first component is provided in the syringe and a second component is provided in a vial. A valve is associated with a fluid aisle between the bottle and the barrel of the syringe. The valve is initially in a closed position that blocks the fluid passage through the aisle. The method includes repositioning a valve and a sliding piston to engage the first component and the second component. The first component is mixed with the second component to form a medicament and the dose is aspirated into the syringe.

In still another aspect, the invention comprises a method of preparing a composition comprising providing a syringe having a cartridge chamber containing a first component and providing a cartridge having a second component The piston of the compartment. The piston includes a piston sleeve and a sleeve insert. The sleeve insert includes a tip and a body having a sealing portion that is overmolded onto one end of the tip and the piston sleeve. The sealing portion has at least one opening therethrough. The method includes rotating a piston sleeve relative to a cannula insert to establish fluid communication between the compartment and the barrel chamber. The piston is slid to join the first component and the second component, and the first component is mixed with the second component to form a composition. The composition is aspirated into the injection chamber.

10‧‧‧Mixed assembly/mixing/handling system/system

100‧‧‧ syringe/injector/injection body

102‧‧‧Injection chamber/internal chamber

103‧‧‧Internal cone area

200‧‧‧Piston/insert/injection piston

202‧‧‧ first end

203‧‧‧Piston tip/tip

204‧‧‧second end

205,205'‧‧‧Piston rod/rod

206‧‧‧ bottle mouth / mouth

206a‧‧‧Internal piston bottle mouth

208,208a‧‧‧ Sealing section

209‧‧‧ openings

210‧‧‧Piston fins

211‧‧‧Accept slot

213‧‧‧Conical wall

219,219a‧‧‧ openings

220‧‧‧Channel/fluid aisle/fluid channel

223,304,306‧‧‧ highlight

230‧‧‧Sleeve inserts/inserts

231‧‧‧Cover part/cover

232‧‧‧ channel

233‧‧‧ rod part/piston rod/insert

234‧‧‧ collar

235‧‧‧ rod part

237‧‧‧Annex

239‧‧‧Disc section

240‧‧‧ piston bushing/sleeve/sleeve section

242‧‧‧Foundation Ring

243‧‧‧ first end

247‧‧‧second end / opposite end

250‧‧‧ openings

255‧‧‧ container

257‧‧‧Compressed spring

258‧‧‧keeper

260,262‧‧‧Extended fins/wings

300‧‧‧ valve

302‧‧‧ valve body

310‧‧‧ bonnet

400‧‧‧ piercing structure/piercing device

401‧‧‧Head section/head section

402‧‧‧ tip

402a‧‧‧ Opening

403‧‧‧ rod/body part

404‧‧‧Basic surface

406‧‧‧ channel

408‧‧‧ access hole

500‧‧‧ bottles

510‧‧‧ bottle shell/shell

600‧‧‧ bottle shell

602‧‧‧Shell parts / first part / first part / container part

604‧‧‧Part 2 / Second part / part / container part

606‧‧‧Adapter Accessories

608‧‧‧ rod part/rod

620‧‧‧Disc structure

1 is a side view and partial cross section of a hybrid assembly in accordance with an aspect of the present invention Figure.

Figure 2 is a side elevation and partial cross-sectional view of a portion of an injection device in accordance with an aspect of the present invention.

Figure 3A is a side elevational view of a portion of an injection device having a sliding housing disposed at a first position.

Figure 3B is a side elevational view of the portion of the injection device of Figure 3A showing the sliding housing disposed at the second position.

4A is a side elevational view of a mixing assembly in accordance with an aspect of the present invention.

Figure 4B is an exploded view of the assembly shown in Figure 4A.

Figure 5A is an exploded side elevational view of an injection piston in accordance with an aspect of the present invention.

Figure 5B is a partial enlarged view of the assembled injection device shown in Figure 5A.

Figure 5C is a side elevational view of the assembled portion of the injection piston shown in Figure 5A.

Figure 6 is a side elevational view of an injection piston having a tip portion connectable to an alternate stem portion in accordance with an aspect of the present invention.

Figure 7 is an exploded side elevational view of another injection piston configuration in accordance with one aspect of the present invention.

Figure 8 is a side elevational view of a piercing device in accordance with an aspect of the present invention.

Figure 9 is a side elevational view of the piston assembly of Figure 7 in an assembled configuration.

Figure 10 is an exploded side elevational view of an alternate mixing assembly in accordance with another aspect of the present invention.

Figure 11A is an exploded side elevational view of a portion of the system shown in Figure 10.

Figure 11B is an enlarged cross-sectional view of a portion of the assembled form of the system depicted in Figure 10.

Figure 12 is a side elevational view of the assembled device of Figure 10 with alternative features.

In general, the present invention provides methods and apparatus for combining and mixing components to produce a mixture and comprising allowing uncontaminated components or mixtures or not exposing them to a non-negative This combined and mixed device configuration occurs in the case of a bacterial environment. In particular, the method of the present invention involves combining and mixing the components to produce a dosageing agent such as a drug and including the agent in a particular aspect. Thus, the device configuration of the present invention allows for the incorporation of separate components such that the combined and mixed components are ready to be applied. The general concepts and example apparatus in accordance with the present invention are illustrated in the accompanying Figures 1-12.

The apparatus and method described and exemplified herein may be used in conjunction with the apparatus and method described in U.S. Patent Application Serial No. 11/238,880, filed on Sep. Its alternative configuration. The specification and figures of the application from this earlier application are hereby incorporated herein by reference. It will be appreciated that many of the concepts of the present invention can be used in conjunction with or can be adapted to other device groups, including conventional injection devices and components, injection devices and components described in the earlier applications, and injection devices and components yet to be developed. state.

In the case where the device according to the invention is used to prepare a medicament, the device is preferably a closed system mixing assembly. An example of a hybrid assembly 10 in accordance with one embodiment of the present invention is illustrated in FIG. The mixing assembly 10 can include an injection body (or cartridge) 100 and a piston 200 having a fluid aisle that is a portion of its length (discussed further below). In some cases, there may be a reversible attachment cover (not shown) that provides a fluid tight portion at the forward end of one of the injection bodies.

The piston 200 has a first end 202 and an opposite second end 204 that define the total length of the piston. A valve 300 is associated with a fluid passage that passes through a portion of the length of the piston. A bottle opening 206 is disposed along a section of the length of the piston rod and is configured to receive a bottle of 500 intimidation within the mouth of the bottle. Preferably, the fluid passageway through the piston extends from the mouth of the bottle through the first end 202.

The piston 200 further includes a sealing portion 208 that is capable of forming a sliding fluid tight seal between the inner wall of the injection body and the side wall of the piston seal portion. Valve 300 can be configured to selectively control fluid communication between the injection chamber and bottle 500.

Referring to Figure 2, a fluid aisle 220 is illustrated that extends from the first end 202 through the seal Portion 208 extends through the piston to the mouth 206. A piercing device 400 can be associated with the fluid channel 220 and can extend into the port 206. An example piercing device can be as described in the earlier application. The piercing device 400 can have a fluid passage therethrough and can be configured to pierce the bottle septum and remain across the septum to establish fluid communication between the interior of the bottle and the fluid aisle 220.

The mouth 206 can be formed by removing all or a portion of one or more piston fins 210. Preferably, a sufficient tab structure is maintained to allow the bottle to remain and stabilize within the port 206.

Valve 300 can be, for example, a two-way valve as illustrated or can be of the alternative valve type as described in the earlier application.

For the injection assembly illustrated in Figures 1 and 2, the device is preferably initially provided in a configuration in which the bottle is sealed and disposed at a non-contact position relative to the piercing structure 400. In use preparation, the bottle can be repositioned to contact the piercing device 400 and slide into the inlet, allowing the device 400 to pierce and span the septum. Valve 300 can then be repositioned to an "open" position to establish fluid communication between the bottle and the injection chamber. Sliding of the piston relative to the syringe can be used to combine the injected contents with the contents of the bottle. The two components can be mixed by repeatedly sliding the piston or by means of a stirring device. The mixed component can then be aspirated into the syringe and the valve closed to prepare for the preparation of the application.

Referring to Figure 3A, an alternative internal piston bottle port configuration is illustrated. The features of the illustrated device, which are identical to the pistons described earlier, are numbered identically. Additional or different features are indicated relative to the prior device by an additional letter or with a unique numeric identifier.

The illustrated piston 200 has an internal aisle that extends from the first end 202 to an internal piston finish 206a. The inner stem finish is configured to receive a vial 510 that covers a vial (not shown). The bottle housing can be inserted through an opening in the second end 204 of the piston. Referring to Figure 3B, a plurality of receiving slots 211 can be configured to guide and position the housing 510 within the finish. Piston 200 can include a piercing structure (not shown) associated with the mouth of the bottle and the fluid aisle. Better The piston 200 can be initially provided such that the outer casing 510 and a bottle that is internally received within the outer casing are placed in a non-contact position such that the piercing device does not contact or penetrate the bottle or membrane. During preparation for use, the bottle and inner bottles can slide toward the first end 202 to allow penetration of the bottle septum or cap by the piercing device, thereby establishing fluid communication between the interior of the bottle and the fluid aisle of the piston . The fluid passage through the aisle can be selectively controlled by valve 300. Preparation of a medicament for administering a personal can be performed by providing an associated syringe (not shown) and using a method similar to that described above for the apparatus depicted in FIG.

Another alternative configuration of the present invention is described with reference to Figures 4A-4B. Referring initially to Figure 4A, a piston 200 can be inserted into a syringe 100 having an internal chamber 102. The injection piston 200 has an internal aisle that passes through the abutment so that the aisle traverses the length of the piston. The fluid passage through the aisle is selectively controlled by a valve 300 associated with this aisle.

As illustrated, a first end 202 (see FIG. 4B) is inserted into the syringe and a vial housing 600 is associated with the second end 204 of the piston. The bottle housing 600 can include, for example, two components 602 and 604. The first component 602 (in certain instances) may extend for one of the pistons 200. The outer casing component 602 can be integrated with the piston 200, permanently attached to the piston 200, or reversibly attached to the piston 200. The second portion 604 of the bottle housing can be configured to engage the first portion 602 such that a bottle inserted into the container can be completely enclosed within the housing. This closure of a drug bottle prevents damage to the bottle and can advantageously avoid removal and incorrect replacement of the bottle and/or inadvertent replacement of the bottle with another bottle that may contain an incorrect diluent or other agent.

Engagement of the second component 604 of the outer casing with the first component of the outer casing can include, for example, inserting a portion of the component 604 into the first component, inserting a portion of the component 602 into the component 604, and screwing one of the two components Into the other of the two components, and/or use other suitable assembly or joining techniques. In a particular embodiment, component 604 is preferably configurable to stabilize at a first location and upon application of force (sliding, torsional or other force based on the design of the particular assembly configuration used) The two parts extend to a second position Set. This configuration allows a closed bottle to be moved from a first "non-contact" position relative to a piercing device (see Figure 4B) to a second portion of the piercing device capable of piercing a bottle of septum or other capping sleeve. Access to the "location" and thereby provide access to the contents of the bottle.

In a particular embodiment, the bottle housing portion can have an adapter attachment 606 that is configured to adapt the injection device for use with a syringe pump. The attachment preferably includes a stem 608 that protrudes from the component 604, wherein the stem has a first diameter. The stem portion 608 extends to a disc structure 610, wherein the disc structure has a diameter that is larger than the diameter of the stem structure and is configured for insertion into a slot in one of the piston rods of a syringe pump. This configuration may allow the device according to the invention to be used in a conventional syringe pump. The presence of the insertable disc (when inserted into a slot of the piston rod of the syringe pump) prevents inadvertent advancement of the plunger when the pump is closed. Alternatively, the device of the present invention can be manually manipulated.

Referring to Figure 4B, an exploded view of the device depicted in Figure 4A is shown. These figures illustrate the combination of the piercing device 400, which can be at the second end 204 of the piston 200 and can extend into the first component 602 of the bottle housing. FIG. 4B additionally illustrates an alternative placement of valve 300 relative to the overall length of piston 200. It should be understood that the placement of the valve 300 along the length of the piston is not limited to any particular location and the depicted position is for illustrative purposes only.

As further illustrated in FIG. 4B, a sealing portion 208 can be mounted to the first end 202 of the injection piston 200. The sealing portion 208 preferably has an outer diameter along at least a portion of its length that forms a fluid tight portion between the chamber wall and the sealing portion. Where the piston 200 includes an internal fluid aisle, the sealing portion 208 preferably has one or more openings to allow fluid communication between the internal passage of the piston and the injection chamber.

The mixing/applying system 10 depicted in Figures 4A-4B can initially be provided at a "non-contact" position where the piercing structure 400 does not pierce the lid or septum of the bottle 500. In a particular configuration, a plastic shrink film can be used at least at the junction of the two outer casing members to stabilize the positioning of the container members 602 and 604 relative to each other. The shrink film provides a sterile holder and prevents the piercing device from inadvertently or unintentionally engaging the bottle septum. Positioning can also or alternatively be used A form-fitting weld or a molded attachment member in which a breakable attachment member that can be broken by application of a force (torsion, slip or other force depending on the particular containment configuration and the location of the frangible attachment member) is stabilized. The two-part container portion of the described injection device configuration can be formed using a material such as a plastic material, preferably a hard plastic material. Spot welding or tack welding can be accomplished using, for example, RF welding, microwave welding, heat welding, or other suitable plastic welding.

Another aspect of the present invention is described with reference to Figures 5A-5C. In general, this aspect of the invention relates to overmolding an elastomeric sealing portion onto a hard plastic body block of various components of the apparatus according to the present invention. Overmolding involves directly forming an overlying component onto a lower support member. In addition to the circumstances specifically described in this particular aspect of the invention, overmolding can be used in conjunction with an alternative piston and valve body. Alternative pistons and valve bodies may include, for example, the alternative pistons and valves described herein, the pistons and valves described in the earlier application, the conventional pistons and valves, and the piston and valve configurations yet to be developed.

Referring initially to Figure 5A, a piston 200 is illustrated having a valve 300 configured to fit an opening 250 and having a channel 220 extending longitudinally through the piston. A piston seal portion 208a is illustrated having an opening 219 that extends through the seal portion. Although FIG. 5A illustrates the piston 200 in an exploded view, it will be appreciated that the sealing portion 208a is permanently attached to the piston during the overmolding process.

The piston 200 preferably has at least one projection 223 disposed at or adjacent the first end 202 of the piston. The protruding portion or the protruding portions can advantageously support the overmolded sealing portion and can assist in retaining the sealing portion on the first end of the piston. Where the piston is configured to have a fluid aisle or passage therethrough, the overmolding process preferably provides an overmolded sealing portion for passage through one or more openings of the sealing portion The passage of the piston is in fluid communication with an associated inner region of the injection body.

The overmolding process used can be adapted to various injection body designs such that the overmolded sealing portion has a front end that is shaped to conform to the front end of the injection body The cone/shape of the inside of the injection body. The sealing portion is preferably shaped to provide a seal diameter that allows the sealing portion to be inserted and moved into the injection chamber while providing a fluid tight portion along the sidewall of the chamber. In a particular aspect, the diameter/size of the seal mold can be modified to produce a seal portion that is adapted to the varying syringe size without changing the piston size/diameter.

In a similar aspect, valve 300 can include a valve body 302 and an overmolded valve cover 310. The valve body 302 preferably has one or more protruding portions 304, 306 configured to support and retain the overmolded cover 310.

Valve 300 can be, for example, a push-pull type valve as illustrated in Figure 5A. In the configuration shown, the push-pull valve body has a larger projection 306 at the insertion end of the valve. The presence of the overhanging portion provides a shape configuration to assist in positioning and/or retaining the valve within the mouth when the valve is pulled to an open position. It will be appreciated that the present invention contemplates the use of alternative valve types, for example, a rotatable valve having an opening through the body and overmolding the sealing portion.

The bonnet 310 and the sealing portion 208a may comprise, for example, an elastomeric material. The elastic materials used may be the same or may be different from each other. Similarly, piston 200 and valve body 302 may be formed of a hard plastic material and may be the same or may be different relative to each other. Examples of elastomeric materials that may be used include, but are not limited to, polyurethane, polypropylene-EPDM, other polypropylene, polyoxyalkylene and/or polyoxyxides, butyl materials, isoprene, neoprene, poly Ethylene and various copolymers, composites, blends or other combinations of such materials. Examples of plastics that can be used in the formation of pistons and/or valve bodies include, but are not limited to, polyethylene, polypropylene, polycycloolefins, polyvinyl chloride (PVC), polyamines (including aliphatic and aromatic variants). , polyesters, polycarbonates, polyacrylates, polyurethanes, copolymers, blends, composites, and combinations thereof.

Turning to Fig. 5B, the overmolded sealing portion 208a on the piston 200 supported by the protruding portion 223 is illustrated. It also illustrates the passage 220 that passes through the piston and through the sealing portion 208a. Referring to Figure 5C, the overmolded cover 310 on the valve body 302 supported by the projections 304 and 306 is illustrated.

In the case of overmolding to form a piston and/or valve according to the present invention, the rod/book The body portion can be fabricated in a first process and the overmolded sealing portion/cover portion can be formed in a second process. Overmolding will directly form the sealing portion/cover on the body or stem portion. Overmolding may occur directly after forming the underlying component, or the underlying component may be initially formed and removed, transferred, and/or stored from the corresponding die prior to the overmolding process.

The overmolding process advantageously avoids manual assembly of the piston or body relative to the lid or plug. Additional advantages of providing an overmolded elastomeric seal portion include minimizing or preventing fluid leakage between the seal portion and the underlying piston, and a secure attachment such that the seal portion rotates or pulls the piston within the syringe relative to the syringe The piston will not be pulled away during the period. Additionally, the sealing portion can be configured to have a thin wall that spans the first end of the piston. The thin wall of the overmolded sealing portion reduces the rebound of the piston and thereby minimizes backflow of fluid returning through the tip of the syringe, relative to conventional piston seal portions. Additionally, the sealing portion can be shaped to have a central protrusion on the front face (not shown) that is configured to be at least partially inserted into the fluid passageway through the injection tip to further minimize fluid retained in the syringe . This feature can be particularly advantageous for the application of expensive pharmaceutical agents.

Referring to Figure 6, overmolding can also be combined with a multi-component piston configuration. In this aspect, a piston seal portion 208 can be overmolded onto a piston tip 203 that can be screwed or otherwise attached to the replacement piston rod 205, 205'. The rods 205 and 205' and the tip 203 can have internal fluid passages or alternatively solid blocks. The tip 203 can be joined to a piston rod 205 or 205' by inserting one of the tip attachment portions into one of the openings 209 of the stem 205 or 205'. In a particular configuration, the joint can be screwed, snap-locked, press-fitted, coated with a suitable adhesive or other suitable joining technique.

Cover molding the sealing portion 208 may be formed to have a diameter, diameter "d _1" may be used depending on the injection body (not shown) of "d _1" is changed. Together with an appropriate diameter tip portion may cover molding for sealing with a syringe with a particular use (e.g., d ₂ or d ₃₎ one of the piston engagement. Therefore, a single tip configuration can be used for a wide range of seals, syringes and piston sizes.

Another embodiment of the present invention is described with reference to Figures 7-9. Referring initially to Figure 7, the piston 200 can include a piston sleeve 240 and a sleeve insert 230 configured to be inserted into the sleeve 240. The sleeve portion 240 can have a sealing portion 208 mounted to the first end 202. The sealing portion can have an opening 219a that passes through the side of the sealing portion and is aligned with a similar opening through the sleeve portion 240. The sleeve 240 can additionally have a base ring 242 or other chassis to allow manipulation of the sleeve.

The cannula insert 230 can include a channel 232 that extends from a first end 243 of the piston insert along an outer surface of the insert and through a collar 234 at the opposite end 247 of the insert. A piercing structure 400 can be provided for engagement with the second end 247 of the piston insert. Referring to Figure 8, this shows a detailed configuration of one example of a piercing device configuration that can be used in conjunction with the piston illustrated in Figure 7.

Piercing structure 400 depicts an illustrative piercing structure in accordance with the present invention. The piercing structure 400 can be described as having a head section 401 that includes a tip end 402 disposed at a first end. The piercing structure 400 additionally has a stem/body portion 403 that extends from the head portion 401 to a base surface 404 disposed at a second end of the structure opposite the first end. A channel 406 or an alternate fluid aisle extends through the base surface and preferably through the body portion 403.

The piercing structure 400 preferably includes an opening 402a that is aligned with the channel 232 of the insert 200 once the base of the piercing structure is coupled to the piston 200.

The piercing structure shown in Figure 8 is an illustrative shape and form. In a preferred aspect of the invention, the channel 406 extends less than the entirety of the inner length of one of the head segments 401 such that the channel does not pass through the tip 402. Conversely, one or more access apertures 408 are provided, for example, through one or both of the outer surfaces of the head portion. The configuration of the piercing structure in which the passage does not pass through the tip can advantageously minimize or prevent the removal of a diaphragm material or clogging of the passage during a piercing operation. Additional aspects of the piercing structure are set forth in the earlier application.

Referring next to Figure 9, this illustrates the piston assembly shown in Figure 7 in an assembled configuration. Set. The cannula insert 230 is inserted into the cannula portion 240. The insert 230 is rotatable relative to the sleeve portion 240 to allow the two components of the device to act as a rotatable valve. Typically, the first end 202 of the assembled structure will be inserted into a syringe (not shown). The device may initially have an accompanying bottle to make the bottle septum intact. The piercing structure 400 can be used to pierce the bottle septum in preparation for administering a medicament. Rotating the insert 230 relative to the sleeve 240 can be used to align the fluid passage of the insert with the opening 219a through the piston seal portion and through the corresponding opening of the piston sleeve. This alignment establishes a flow communication between the injection chamber and the bottle. Subsequent combinations and mixing of the pharmaceutical components can be performed as described above. Once the mixing is complete, the valve can be closed by rotating the insert 230 relative to the cannula. The application composition can then be applied or can be stored prior to application.

Another mixing and actuation system 10 having a multi-component piston is depicted in Figures 10-12. Referring initially to Figure 10, system 10 can include a syringe 100 having an internal chamber 102. System 10 additionally includes a piston 200 including a piston sleeve 240 and a sleeve insert 230. The insert 230 can be described as having a stem portion 233 with at least a portion of the stem portion 233 being hollow to serve as a container 255. An insert cover portion 231 can be configured to attach to the piston rod 233, thereby covering and closing the container 255. An attachment 237 can extend from the piston insert. The attachment 237 can include a stem portion 235 and a disc portion 239, wherein the disc portion 239 is configured to fit a slot in one of the piston rods of a syringe pump.

The sleeve portion 240 can include a piston seal portion 208. The sealing portion 208 is preferably overmolded and may include a shape having a tapered wall 213 that matches the inner tapered region 103 of the injection chamber 102.

Referring to Figure 11A, the cover portion 231 can be configured to provide a valve action using an insertion compression spring 257 and an overlying retainer 258. Cover 231 and retainer 258 may be formed from a hard plastic material such as the materials described above. The spring 257 can be formed from an elastic material such as the elastic material as set forth above.

Referring next to Figure 11B, in the illustrated embodiment, the overmolded sealing portion 208 can be overmolded onto the piston sleeve 240 and overmolded onto the cover 231. An internal valve spring and retainer are provided prior to the overmolding process. Once the overmolding process is completed, the stem portion 233 can be positioned by inserting the rod into the sleeve portion 240. When inserted into the cannula, the inner container of insert 233 will typically contain a component such as a lyophilized powder. Cover 231 and stem portion 233 are preferably configured to include a snap fit, press fit, or other suitable engagement configuration such that once engaged, the cover and stem portions are not pulled apart when the piston is pulled back.

Figure 12 shows an assembly device similar to the device shown in Figure 10 with additional optional features. As illustrated, the piston 200 including the cannula 240 and the insert 230 is inserted into a syringe 100. The sleeve 240 can include an extension tab 262, and the insert 230 can also include an extension tab 260. An extension flap is present on the sleeve and the insert assists in manipulating the valve associated with the piston. Squeezing the flaps together in the A direction opens the valve. The insert can then be rotated relative to the cannula (direction B) to position the tabs to "lock" the cannula and insert the positions opposite each other thereby locking the valve to the open position. To close the valve, the insert can be rotated in the opposite direction and the tab 260 can be removed relative to the tab 262.

In addition to the inner container in the insert 230, in place of the bottle described earlier, a device prepared using the apparatus depicted in Figure 12 can be used to prepare a apply preparation in a manner similar to that described above. The mixing/applying system 10 shown in Figure 12 can additionally include an attachment associated with the piston and the counter injector 100, wherein the attachment is configured to permit insertion into a slot of one of the piston rods of a syringe pump.

The packaging of the devices of the embodiments described herein may use conventional packaging techniques, or may employ packaging techniques suitable for the particular device being packaged as described in the earlier application.

The features and embodiments described herein can be combined with each other where appropriate and can be used in conjunction with the features and embodiments disclosed in the application of the earlier application. Features and embodiments of the present invention may be adapted or adapted to conventional injection components, bottles and devices, and still to be developed They are used in combination.

10‧‧‧Mixed assembly/mixing/handling system/system

100‧‧‧ syringe/injector/injection body

102‧‧‧Injection chamber/internal chamber

103‧‧‧Internal cone area

200‧‧‧Piston/insert/injection piston

208‧‧‧ sealing part

213‧‧‧Conical wall

230‧‧‧Sleeve inserts/inserts

231‧‧‧Cover part/cover

233‧‧‧ rod part/piston rod/insert

235‧‧‧ rod part

237‧‧‧Annex

239‧‧‧Disc section

240‧‧‧ piston bushing/sleeve/sleeve section

255‧‧‧ container

Claims (14)

An injection device comprising: a syringe; a single piston having a first end insertable into the syringe, a second end opposite the first end, and the second end extending Outside the syringe; a port disposed in the second end of the piston, configured to receive an object defining an opening; and a cover configured to engage the opening. The injection device of claim 1, further comprising a piston sealing portion disposed at the first end of the piston, the piston sealing portion being overmolded on one of the rod portions of the piston. The injection device of claim 1, wherein the mouth is a bottle of outer casing, and the bottle casing includes a first member attached to the second end of the piston and a second member engageable to the first member. The injection device of claim 3, wherein the first component is reversibly attached to the second end of the piston. The injection device of claim 3, wherein the first component comprises a cannula insert having a first end insertable into the sleeve, an opposite second end, and The length defined by the distance between the first end and the second end. The injection device of claim 5, further comprising a compartment disposed within the cannula insert. a single injection piston comprising: a first end insertable into a syringe, a second end opposite the first end, and the second end extends outside the syringe; a port disposed in the second end of the piston, configured to receive an object defining an opening; a cover configured to engage the opening; a stem portion having one or more a protruding portion; and a sealing portion that is overmolded on the rod portion and covers the or the protruding portion. The injection piston of claim 7, wherein the sealing portion comprises at least one of a cyclic olefin homopolymer material and a cyclic olefin copolymer material. The injection piston of claim 7, wherein the stem portion includes a first portion and a second portion, and wherein the sealing portion is overmolded onto the first portion prior to joining the first portion and the second portion. The injection piston of claim 9, wherein the first rod portion and the second rod portion have different diameters relative to each other. An injection device comprising: a syringe; a piston comprising: a first end insertable into the syringe; and a second end opposite the first end, and the second end extends Outside the syringe; a port disposed in the second end of the piston, configured to receive an object defining an opening; and a cover configured to operatively engage the opening, And the object is held in the mouth when engaged. The injection device of claim 11, wherein the cover is constructed as a cannula insert that is operatively received by one of the ports. The injection device of claim 12, wherein the cannula insert is operable to receive the object. The injection device of claim 12, wherein the cannula insert includes a flange that is configured to be digitally operated when the insert is withdrawn from the port.