KR20090115848A - Drug casting - Google Patents

Abstract

An injection device assembly includes a dispensing chamber housing and a plunger. The dispensing chamber housing is coupled to a needle. The dispensing chamber housing has an inner surface and an outer surface. The inner surface partially defines a dispensing chamber for holding a quantity of a substance. A dosage of a substance is cast into the dispensing chamber housing or cast onto a plunger that is inserted into the dispensing chamber housing.

Description

Chemical Casting {DRUG CASTING}

Related Applications

The present invention discloses US patent application 11 / 581,629, filed October 16, 2006, US patent application 11 / 581,630, filed October 16, 2006, US patent application 11 / 581,591, filed October 16, 2006. , Part of US patent application Ser. No. 11 / 453,906, filed May 17, 2006.

The present invention relates to a medical device, and more particularly, to an injection device or subassembly thereof cast a drug therein.

Several diseases and conditions of the back part of the eye threaten vision. Some examples include age related macular degeneration (ARMD), choroidal neovascularization (CNV), retinopathy (eg diabetic retinopathy, vitreoretinopathy, retinitis) (Eg, cytomegalovirus (CMV) retinitis), uveitis, macular edema, glaucoma, and neuropathies.

These and other diseases can be treated by injecting drugs into the eye. Such injections are typically made manually using conventional syringes and needles. 1 shows a perspective view of a prior art syringe used to inject medication into the eye. In FIG. 1, the syringe includes a needle 105, a luer hub 110, a chamber 115, a plunger 120, a plunger shaft 125, and a thumb support 130. As is generally known, the drug to be injected is located in the chamber 115. When the thumb support 130 is pressed, the plunger 120 sprays the medicine through the needle 105.

In using such syringes, the surgeon (with or without the help of a nurse) pierces the tissue of the eye with a needle, keeps the syringe stable, and activates the syringe plunger to inject the drug into the eye. Since the parallax error is affected in the reading of the vernier, the injected volume is usually not controlled in a precise manner. The fluid flow rate is also not controlled. Tissue damage can occur due to "unsteady" injections. Backflow of the drug may occur when the needle is removed from the eye.

Efforts have been made to control the delivery of small amounts of liquid. Commercially available fluid distributors are available from EFD Inc. of Rhode Island, Providence. ULTRA ^™ positive displacement dispenser available from. ULTRA dispensers are generally used to dispense small volumes of industrial adhesives. This utilizes conventional syringes and customized dispensing tips. The syringe plunger operates using an electric stepper motor and working fluid. Paker Hannifin Corporation of Ohio, Cleveland distributes small volume liquid distributors for drug discovery applications manufactured by Aurora Instruments LLC of San Diego, California. Parker / Aurora distributors use a piezoelectric distribution mechanism. Ypsomed, Inc. of Switzerland. Introduced a line of automated injectors and injection pens primarily intended for patients to directly inject insulin or hormones. This product line includes simple disposable pens and electrically controlled powered injectors.

U. S. Patent 6,290, 690 discloses a second viscous fluid (e.g., perfluorocarbon liquid) from the eye in a fluid / fluid exchanger during the surgical procedure to treat retinal detachment or tear and simultaneously into the eye. An ophthalmic system for injecting a viscous fluid (eg silicone oil) is disclosed. Such a system includes a conventional syringe with a plunger. One end of the syringe couples fluidly to a pneumatic source that provides a constant pneumatic pressure to actuate the plunger. The other end of the syringe couples in fluid communication with an infusion cannula through a tube to deliver the viscous fluid to be injected.

Portable hand pieces for reliably injecting medication into the eye are preferred. When the drug is heated or cooled, the drug is in a solid or semi-solid state at room temperature. It may be difficult to introduce these drugs into the infusion device because of the viscosity of the drugs. It is desirable to transfer these chemicals to a more liquid state to cast inside the injection device.

In one embodiment according to the principles of the present invention, the present invention is an injection device assembly having a dosage chamber housing and a plunger. A needle is coupled to the dosing chamber housing. The dosage chamber housing has an inner surface and an outer surface. The inner surface partially defines a dosage chamber for holding a predetermined amount of material. The plunger engages with the inner surface of the dosing chamber housing, is slidable within the dosing chamber housing, and is sealed in fluid communication with the inner surface of the dosing chamber housing. The material is cast inside the dosing chamber housing.

In another embodiment according to the principles of the present invention, the present invention is an injection device assembly having a dosage chamber housing and a plunger. A needle is coupled to the dosing chamber housing. The dosage chamber housing has an inner surface and an outer surface. The inner surface partially defines a dosage chamber for holding a predetermined amount of material. The plunger engages with the inner surface of the dosing chamber housing, is slidable within the dosing chamber housing, and is sealed in fluid communication with the inner surface of the dosing chamber housing. The material is cast on the plunger before the plunger is inserted into the dosing chamber housing.

In another embodiment according to the principles of the present invention, the present invention is a dosage assembly having a plunger having a top surface and a bottom surface and a removable sleeve. The removable sleeve has an inner surface and an outer surface and is mounted over the top surface of the plunger. In this position, the inner surface of the sleeve forms a mold such that the material is cast on the upper surface of the plunger inside the mold.

In another embodiment according to the principles of the present invention, the present invention is a dosage assembly having a dosage chamber housing and a removable plug. The dosing chamber housing engages with the needle. The dosage chamber housing has an inner surface and an outer surface. The inner surface partially defines a dosage chamber for holding a predetermined amount of material. A removable plug is located in the needle and prevents the material from exiting the dosing chamber housing. The material is cast inside the dosing chamber housing.

In another embodiment according to the principles of the present invention, the present invention provides a method for producing a liquid comprising: reaching a temperature range at which a substance is brought into a more liquid state; Casting the material into a dosage chamber housing in which the material returns to a solid state; And inserting a plunger into the dosing chamber housing; A method for dosing into an injection device assembly comprising a.

In another embodiment according to the principles of the present invention, the present invention provides a method for producing a liquid comprising: reaching a temperature range at which a substance is brought into a more liquid state; Placing a sleeve around the plunger; Casting the material inside the sleeve and on top of the plunger where the material returns to a more solid state; Removing the sleeve; And inserting the plunger and the material into the dosing chamber housing; It is a method for dosing in an injection device comprising a.

It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide a description of the claimed subject matter. The following description and examples of the present invention illustrate and present additional advantages and objects of the present invention.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present invention and together with the description serve to explain the principles of the invention.

1 is a perspective view of a syringe of the prior art.

2 illustrates an ophthalmic medical device including a finite reusable assembly and a disposable tip segment in accordance with an embodiment of the present invention.

3 illustrates another embodiment of a finite reuse assembly in accordance with the principles of the present invention.

4 illustrates a cross section of a disposable tip segment and a finite reuse assembly according to one embodiment of the invention.

5 is an exploded cross-sectional view of a tip segment for an ophthalmic medical device in accordance with one embodiment of the present invention.

6A and 6B are cross-sectional views of a dosage chamber in which a drug is cast therein according to the principles of the present invention.

7A-7D are cross-sectional views of a plunger in which a drug is cast according to the principles of the present invention.

8A-8G illustrate cross-sectional views of various plungers in accordance with the principles of the present invention.

9A and 9B are end views of various plungers in accordance with the principles of the present invention.

10 is a flow chart of a method of casting a material into an injection device or subassembly thereof in accordance with the principles of the present invention.

11 is a flow chart of a method of casting a material into an injection device or subassembly thereof in accordance with the principles of the present invention.

Reference is now made in detail to exemplary embodiments of the present invention. Examples of such embodiments are shown in the accompanying drawings. Wherever possible, the same reference numbers have been used for the same or similar parts throughout the figures.

2 illustrates an ophthalmic medical device including a finite reusable assembly and a disposable tip segment in accordance with an embodiment of the present invention. In FIG. 2, such a medical device includes a tip segment 205 and a finite reuse assembly 250. Tip segment 205 includes a needle 210, a housing 215, and an optional light source 275. The finite reuse assembly 250 includes a housing 255, a switch 270, a locking device 265, and a threaded portion 260.

Tip segment 205 may be connected to and removed from finite reuse assembly 250. In this embodiment, the tip segment 205 has a thread on the inner surface of the housing 215 that is screwed onto the thread 260 of the finite reuse assembly 250. Lock device 265 also secures tip segment 205 to finite reuse assembly 250. The locking device 265 may be in the form of a button, a sliding switch, or a cantilevered mechanism. Other mechanisms for connecting the tip segment 205 to the finite reuse assembly 250, such as those involving structural features that match each other, are well known to those of ordinary skill in the art. It falls within the scope of the present invention.

Needle 210 is configured to deliver a substance, such as a drug, to the eye. Needle 210 may be of a generally known shape. Preferably, the needle 210 is configured such that its thermal properties are advantageous for use in certain drug delivery. For example, if a heated medication is to be delivered, the needle 210 may be relatively short (a few millimeters) long to aid in the correct delivery of the medication.

The switch 270 is configured to provide an input to the system. For example, switch 270 may be used to operate the system or turn on the heater. Other switches, buttons, or control inputs for the user are generally known and may be used with the finite reuse assembly 250 and / or tip segment 205.

When tip segment 205 is ready for use, optional light source 275 is illuminated. The optional light source 275 may protrude from the housing 215 or may be embedded within the housing 215 in which case the optional light source 275 may be identified through the transparent portion of the housing 215. In another embodiment, the optional light source 275 is replaced with an indicator, such as a liquid crystal display, a segmented display, or other device indicating the condition or condition of the disposable tip segment 205. Can be. For example, optional light source 275 may include, but is not limited to, a system error, a full charge of the battery, a lack of charge of the battery, or other failures such as poor connection between tip segment 205 and finite reuse assembly 250. It may be pulse on or pulse off to indicate status. Although shown on tip segment 205, an optional light source 205 or other indicator may be located on finite reuse assembly 250.

3 illustrates another embodiment of a finite reuse assembly in accordance with the principles of the present invention. Finite reuse assembly 250 includes a button 308, a display 320, and a housing 330. Disposable tip segment 205 is attached to end 340 of finite reuse assembly 250. Button 308 acts to provide input to the system. As with the switch 270, the button 308 can activate a heater or other temperature control device or initiate operation of the plunger. Display 320 is a liquid crystal display, segmented display, or other device that indicates the condition or condition of disposable tip segment 205 or finite reuse assembly 250.

4 illustrates a cross section of a disposable tip segment and a finite reuse assembly according to one embodiment of the invention. 4 shows how tip segment 205 connects to finite reuse assembly 250. In the embodiment of FIG. 4, tip segment 205 includes plunger interface 420, plunger 415, dosing chamber housing 425, tip segment housing 215, temperature control device 450, thermal sensor 460. , Needle 210, dosing chamber 405, interface 530, and tip interface connector 453. The finite reuse assembly 250 includes a mechanical link interface 545, an actuator shaft 510, an actuator 515, a power source 505, a controller 305, a finite reuse assembly housing 255, an interface 535, And a finite reuse assembly interface connector 553.

In tip segment 205, plunger interface 420 is located on one end of plunger 415. The other end of the plunger 415 forms one end of the dosage chamber 405. The plunger 415 is configured to slide in the dosing chamber 405. The outer surface of the plunger 415 is fluid seal to the inner surface of the dosage chamber housing 425. Dosing chamber housing 425 surrounds dosing chamber 405. Typically, the dosage chamber housing 425 has a cylindrical shape. Thus, the dosing chamber 405 also has a cylindrical shape.

The needle 210 couples in fluid communication with the dosing chamber 405. In such a case, material stored in the dosing chamber 405 may pass through the needle 210 and enter the eye. The temperature control device 450 at least partially surrounds the dosage chamber housing 425. In this case, temperature control device 450 is configured to cool and / or heat any material stored in dosing chamber housing 425 and dosing chamber 405. The interface 530 connects the temperature control device 450 to the tip interface connector 453.

The optional thermal sensor 460 provides temperature information to assist in controlling the operation of the temperature control device 450. The thermal sensor 460 may be located near the dosage chamber housing 425 to measure the temperature near the dosage chamber housing 425 or may be located in thermal contact with the dosage chamber housing 425, in which case the thermal sensor may be The temperature of the dosing chamber housing 425 is measured. Thermal sensor 460 may be any number of different devices capable of providing temperature information. For example, thermal sensor 460 may be a resistance device or thermocouple whose resistance varies with temperature. In addition, the thermal sensor is electrically coupled to interface 530 or similar interface.

The components of the tip segment 205 are at least partially surrounded by the tip segment housing 215, including the dosing chamber housing 425, the temperature control device 450, and the plunger 415. In one embodiment according to the principles of the present invention, the plunger 415 is sealed to the inner surface of the dosage chamber housing 425. This seal prevents contamination of any material stored in the dosing chamber 405. For medical purposes, such a seal is desirable. Such a seal may be placed in any position of the dosage chamber housing 425 or the plunger 415.

In the finite reuse assembly 250, the power source 505 provides power to the actuator 515. An interface (not shown) between the power source 505 and the actuator 515 acts as a conduit for providing power to the actuator 515. Actuator 515 is coupled to actuator shaft 510. When the actuator 515 is a stepper motor, the actuator shaft 510 is integral with the actuator 515. The mechanical link interface 545 is connected to the actuator shaft 510. In this configuration, as the actuator 515 moves the actuator shaft 510 upwards towards the needle 210, the mechanical link interface 545 also moves upward towards the needle 210. In another configuration of the present invention, the mechanical link interface 545 and the actuator shaft 510 are a single part. That is, the shaft connected to the actuator 515 includes both the actuator shaft 510 and the mechanical link interface 545 as a single assembly.

In the finite reuse assembly 250, the power source 505 may typically use a rechargeable battery, such as a lithium ion battery, or another type of battery. In addition, any type of power cell is suitable as the power source 505. The power source 505 supplies current to the dosing chamber housing 425 to heat it and change its shape. Optionally, power source 505 may be removed from housing 255 through a door or other similar shape (not shown).

The controller 305 is connected to the finite reuse assembly interface connector 553 via the interface 535. The finite reuse assembly interface connector 553 is located on the top surface of the finite reuse assembly housing 255 adjacent the mechanical link interface 545. In this manner, both the finite reuse assembly interface connector 553 and the mechanical link interface 545 are configured to be connected to the plunger interface 420 and the tip interface connector 453, respectively.

Controller 305 and actuator 515 are connected by an interface (not shown). This interface (not shown) allows the controller 305 to control the operation of the actuator 515. In addition, the interface between the power source 505 and the controller 305 allows the controller 305 to control the operation of the power source 505. In this case, the controller 305 is connected to the power source 505. In the case of a rechargeable battery, charging and discharging of the power source 505 may be controlled.

Controller 305 is typically an integrated circuit having power, input, and output pins capable of performing logic functions. In various embodiments, the controller 305 is a targeted device controller. In such a case, the controller 305 performs specific control functions targeting specific components or components, such as temperature control devices or power supplies. For example, the temperature controller has a basic function of controlling the temperature controller. In another embodiment, the controller 305 is a microprocessor. In such a case, the controller 305 may be programmed to function to control more than one component of the autonomy. In other cases, the controller 305 is not a programmable microprocessor, but instead is a purpose-built controller configured to control different components that perform different functions. Although shown as one component in FIG. 5, the controller 305 may be comprised of many different components or integrated circuits.

Tip segment 205 is configured to attach to or mate with finite reuse assembly 250. In the embodiment of FIG. 4, the plunger interface 420 located on the bottom surface of the plunger 415 is configured to mate with the mechanical link interface 545 located near the top surface of the finite reuse assembly housing 255. Tip interface connector 453 is also configured to be coupled with finite reuse assembly interface connector 533. When tip segment 205 is connected to finite reuse assembly 250 in this manner, actuator 515 and actuator shaft 510 are adjusted to drive plunger 415 upward toward needle 210. In addition, an interface is formed between the controller 305 and the temperature control device 450. Signals can be communicated from the controller 305 to the temperature control device 450 via the interface 535, finite reuse assembly interface connector 553, tip interface connector 453, and interface 530.

In operation, when tip segment 205 is connected to finite reuse assembly 250, controller 305 controls operation of actuator 515. When the actuator 515 is actuated, the actuator shaft 510 moves up towards the needle 210. Subsequently, a mechanical link interface 540 that mates with the plunger interface 420 moves the plunger 415 upward toward the needle 210. Subsequently, material located in the dosing chamber 405 is discharged through the needle 210.

The controller 305 also controls the operation of the temperature control device 450. The temperature control device 450 is configured to cool and / or heat the dosage chamber housing 425 and its contents. Since the dosing chamber housing 425 is at least partially thermally conductive, heating or cooling the dosing chamber housing 425 heats or cools the material located in the dosing chamber 405. Temperature information may be communicated from the thermal sensor 460 back to the controller 305 via the interface 530, the tip interface connector 453, the finite reuse assembly interface connector 553, and the interface 535. This temperature information can be used to control the operation of the temperature control device 450. When the temperature control device 450 is a heater, the controller 305 controls the amount of current entering the temperature control device 450. As more current enters the temperature control device 450, the temperature control device becomes hotter. In this manner, the controller 305 may use a feedback loop that utilizes information from the thermal sensor 460 to control the operation of the temperature control device 450. Any suitable control algorithm, such as a proportional integral derivative (PID) algorithm, can be used to control the operation of the temperature control device 450.

Substances to be delivered to the eye, typically drugs suspended in phase change compounds, are located in the dosing chamber 405. In this manner, the drug and phase change compound contact the inner surface of the dosage chamber housing 425. Phase transition compounds are in a solid or semi-solid state at low temperatures and more liquid at higher temperatures. Such a compound can be heated to a more liquid state by injecting a current into the temperature control device 450 and injected into the eye, where it forms a bolus that erodes over time.

Likewise, reverse gelation compounds can be used. Inverse gelling compounds are solid or semisolid at high temperatures and more liquid at low temperatures. Such compounds may be cooled to a more liquid state by the temperature control device 450 and injected into the eye, where they form pills that melt over time. As such, the temperature control device 450 may be a device for heating the material in the dosing chamber 405 or a device for cooling the material in the dosing chamber 405 (or a combination thereof). The phase shift compound or reverse gelling compound melts over time after being delivered to the eye to provide the desired amount of drug over an extended period of time. The use of phase change compounds or reverse gelling compounds provides better drug dosage with less infusion.

In one embodiment of the invention, the substance in the dosing chamber 405 is a drug that is preloaded into the dosing chamber. In this case, the tip segment 205 is suitable as a single use consumable product. Such disposable products may be assembled at the factory with a single dose of drug.

Although shown as a two-piece device, the injection system of FIG. 4 may be a single piece device. In this case, the tip segment is integrated into a finite reuse assembly to form a single medical device.

5 is a cross-sectional view of a tip segment for an ophthalmic medical device according to one embodiment of the present invention. In FIG. 5, tip segment 205 includes dosing chamber housing 425, tip segment housing 215, thermal sensor 460, needle 210, dosing chamber 405, plunger 415, plunger interface 420. ), A temperature control device 450, an interface 530, a tip interface connector 453, and an optional luer 430. The optional luer secures the needle 210 to the dosage chamber housing 425.

In the embodiment of FIG. 5, the temperature control device 450 operates to reach the appropriate temperature range of the material in the dosing chamber 405. Thermal sensor 460 provides temperature information to controller 305 (not shown) to control temperature control device 450. After the substance reaches the appropriate temperature range, the plunger 415 operates to deliver the substance to the eye through the needle 210. Plunger 415 extends as shown and has an integral shaft.

6A and 6B are cross-sectional views of a dosage chamber in which a drug is cast therein according to the principles of the present invention. In FIG. 6A, the drug suspended in phase transition compound 605 is heated and poured into or dispensed into dosing chamber housing 425 where it is cooled and solidified. A plug 610 is located in the needle 210 to prevent the drug suspended in the phase change compound 605 from escaping through the needle 210 when in a liquid or semi-liquid state. . After the drug floating in the phase transition compound 605 is cast into the dosing chamber housing 425, the plunger 415 is inserted as shown in FIG. 6B.

Casting a drug suspended in phase transition compound 605 into the dosing chamber housing 425 allows a small gauge needle to be used. In one embodiment according to the principles of the present invention, a 25 gauge needle is used. It is difficult to introduce the drug suspended in the phase shift compound 605 into the dosing chamber housing 425 through a small gauge needle. It can also be difficult to handle at room temperature when the phase change compound is in the form of a wax that is a solid phase. Incorporation into the injection device when such materials are in a more solid form will result in entrapment of air, inaccurate dosing, and the like. Appropriate dosages can be easily stored in a pre-loaded injection device by “melting” the material and pouring it into the dosage chamber housing 425.

Drugs suspended in the reverse gelling compound may also be used. In this case, the drug suspended in the reverse gelling compound is cooled until it is more liquid and then introduced into the dosing chamber housing 425 where it is warmed and solidified.

7A-7D are cross-sectional views of a plunger in which a drug is cast according to the principles of the present invention. 7A shows the plunger. In FIGS. 7B and 7C, the sleeve 705 is disposed around the plunger 415 and the drug suspended in the phase change or reverse gelling compound 710 is introduced into the sleeve 705 on top of the plunger 415. Sleeve 705 has an inner and an outer surface. The inner surface contains the material. As the material returns to room temperature, the material solidifies and the sleeve 705 is removed. The sleeve 705 is hinged or its inner surface coated so that it can be removed. In addition, the sleeve 705 may also have a guide (not shown) to properly position the plunger. As shown in FIG. 7D, after the sleeve 705 is removed, the plunger 415 will have the drug and compound 710 formed thereon. The plunger 415 is now ready to be placed in the dosage chamber housing 425. This casting operation facilitates the assembly of the preloaded injection device.

8A-8G illustrate cross-sectional views of various plungers in accordance with the principles of the present invention. Different plunger shapes may be used for the casting operation shown in FIGS. 7A-7D. In some cases, it is desirable to provide a shape or texture on the top surface of the plunger 415. Such features or textures allow the injected drugs and compounds to be better attached to the plunger 415. Better adherence facilitates the assembly of pre-dosed infusion devices. In particular, the top surface of the plunger 415 in Figures 8A-8E has a specific shape. In FIG. 8F the top surface of the plunger 415 is flat and in FIG. 8G the top surface of the plunger is textured.

9A and 9B are top views of various plungers according to the principles of the present invention. In FIG. 9A, there are three small holes or indentations in the top surface of the plunger 415. In FIG. 9B, one hole or depression is present in the top surface of the plunger 415. Various other plunger shapes are possible, and those presented herein are merely examples.

10 is a flow chart of a method of casting a material into an injection device or subassembly thereof in accordance with the principles of the present invention. In step 1010, the substance enters a temperature range that is in a more liquid state. For the phase change material, heat is applied to bring the phase change material to a more liquid state. In step 1020, the material is introduced for casting into the dosing chamber housing. The plug is located in a needle that is in fluid communication with the dosing chamber housing. The plug prevents material from leaving the dosing chamber housing through the needle when the material is in a more liquid state. After the material is introduced into the dosing chamber housing, the material gradually approaches ambient temperature and becomes more solid. In step 1030, the plunger is inserted into the dosing chamber housing. In this way the infusion device is ready to be transported for use by a medical professional. If the substance is a medicament for treating the condition of the eye, the correct dosage can be cast into the dosage chamber housing under sterile conditions at the place of manufacture. Pre-dose infusion devices (with the correct dosage) can be placed in a sterile pack for delivery. This manufacturing process makes it possible to accurately dispense refractory materials under a controlled environment.

11 is a flow chart of a method of casting a material into an input device or subassembly thereof, in accordance with the principles of the present invention. In step 1010, the substance enters a temperature range that is in a more liquid state. For the phase change material, heat is applied to bring the phase change material to a more liquid state. In step 1020, a sleeve is disposed around the top of the plunger. The sleeve forms a mold into which the material can be introduced. As such, the inner surface of the sleeve and the top of the plunger form a container into which the material can be injected. In step 1130, material is introduced for casting into the sleeve and into the plunger top. After the material is introduced into the sleeve, the material gradually approaches room temperature and becomes a solid state. In step 1140 the sleeve is removed leaving the material on the plunger top surface. In step 1150, the material and the plunger are inserted into the dosing chamber housing. The infusion device is now predosed and ready for use. If the substance is a medicament for treating the condition of the eye, the correct dosage can be cast into the dosage chamber housing under sterile conditions at the place of manufacture. Pre-dose infusion devices (with the correct dosage) can be placed in a sterile pack for delivery. This manufacturing process makes it possible to accurately dispense refractory materials under a controlled environment.

From the above, it will be appreciated that the present invention provides an improved system and method for delivering the correct volume of material. The present invention provides an injection device in which a drug is cast therein. The drug is heated or cooled (as the case may be) and converted to a more liquid state suitable for introducing the drug into the dosing chamber or plunger. The invention is illustrated by way of example herein, and various modifications may be made by those skilled in the art to which the invention pertains.

Although the present invention has been described with reference to ophthalmic infusion devices, the invention is suitable for use with any type of infusion device. Other embodiments of the present invention will be apparent to those of ordinary skill in the art in view of the practice and description of the invention disclosed herein. The description and examples of the present invention are intended to be considered by way of example only, and the true scope and spirit of the present invention will be indicated by the following claims.

Claims (31)

An injection device assembly, A dosing chamber housing having a needle coupled thereto, comprising: a dosing chamber housing having an inner surface and an outer surface, the inner surface partially defining a dosing chamber for holding a predetermined amount of material; And A plunger engaged with an inner surface of the dosing chamber housing, the plunger being slidable within the dosing chamber housing and sealed in fluid communication with the inner surface of the dosing chamber housing; Including; The material is cast inside the dosing chamber housing, Injection device assembly. The method of claim 1, A removable plug located within the needle, further comprising a plug to prevent the material from exiting the dosage chamber housing when the material is cast into the dosage chamber housing, Injection device assembly. The method of claim 1, Further comprising a temperature control device at least partially surrounding the dosage chamber housing, Injection device assembly. The method of claim 3, Further comprising a controller for controlling the temperature control device, Injection device assembly. The method of claim 4, wherein Further comprising a thermal sensor for temperature measurement, located near the dosing chamber housing, Injection device assembly. The method of claim 5, The controller controls the temperature control device using the measured temperature, Injection device assembly. The method of claim 1, Further comprising a power source for providing power to the temperature control device, Injection device assembly. The method of claim 1, The substance is a drug for treating an eye condition, Injection device assembly. An injection device assembly, A dosing chamber housing having a needle coupled thereto, comprising: a dosing chamber housing having an inner surface and an outer surface, the inner surface partially defining a dosing chamber for holding a predetermined amount of material; And A plunger engaged with an inner surface of the dosing chamber housing, the plunger being slidable within the dosing chamber housing and sealed in fluid communication with the inner surface of the dosing chamber housing; Including; The material is cast onto the plunger before the plunger is inserted into the dosing chamber housing. Injection device assembly. The method of claim 9, Further comprising a temperature control device at least partially surrounding the dosage chamber housing, Injection device assembly. The method of claim 10, Further comprising a controller for controlling the temperature control device, Injection device assembly. The method of claim 11, Further comprising a thermal sensor for temperature measurement, located near the dosing chamber housing, Injection device assembly. The method of claim 12, The controller controls the temperature control device using the measured temperature, Injection device assembly. The method of claim 9, Further comprising a power source for providing power to the temperature control device, Injection device assembly. The method of claim 9, The substance is a drug for treating an eye condition, Injection device assembly. As a dosage assembly, A plunger having an upper surface and a lower surface; A removable sleeve having an inner surface and an outer surface, said removable sleeve mounted over an upper surface of said plunger, said inner surface forming a mold such that said material is cast on said upper surface of said plunger within said mold; And A casting material located on an upper surface of the plunger; Including, Dosage assembly. The method of claim 16, The upper surface of the plunger is shaped to accommodate the casting material, Dosage assembly. The method of claim 16, The upper surface of the plunger has a texture, Dosage assembly. The method of claim 16, The sleeve is hinged, Dosage assembly. The method of claim 16, The inner surface of the sleeve is coated, Dosage assembly. As a dosage assembly, A dosing chamber housing having a needle coupled thereto, comprising: a dosing chamber housing having an inner surface and an outer surface, the inner surface partially defining a dosing chamber for holding a predetermined amount of material; And A removable plug located within the needle, the plug for preventing the material from exiting the dosing chamber housing; Including, Wherein the material is cast inside the dosing chamber housing, Dosage assembly. The method of claim 21, Further comprising a plunger sealingly engaged in fluid communication with an inner surface of the dosing chamber housing, Dosage assembly. A method for dosing into an injection device assembly, Reaching the temperature range at which the material is in a more liquid state; Casting the material into a dosage chamber housing in which the material returns to a solid state; And Inserting a plunger into the dosing chamber housing; Including, A method for dosing into an injection device assembly. The method of claim 23, wherein After the material is cast inside the dosing chamber housing, further comprising removing a plug from a needle fluidly coupled to the dosing chamber housing, A method for dosing into an injection device assembly. The method of claim 23, wherein Before the material is cast into the dosing chamber housing, inserting a plug inside the needle that is in fluid communication with the dosing chamber housing, A method for dosing into an injection device assembly. The method of claim 23, wherein Reaching the temperature range at which the material is in a more liquid state further comprises heating the material, A method for dosing into an injection device assembly. The method of claim 23, wherein Casting the material into a dosage chamber housing in which the material returns to a solid state further comprises casting the correct dosage within the dosage chamber housing in a sterile environment; A method for dosing into an injection device assembly. As a method for administering to an infusion device, Reaching the temperature range at which the material is in a more liquid state; Placing a sleeve around the plunger; Casting the material inside the sleeve and on top of the plunger where the material returns to a more solid state; Removing the sleeve; And Inserting the plunger and the material into the dosing chamber housing; Including, Method for dosing into an infusion device. The method of claim 28, Further waiting for the material to reach a temperature near room temperature before removing the sleeve; Method for dosing into an infusion device. The method of claim 28, Reaching the temperature range at which the material is in a more liquid state further comprises heating the material, Method for dosing into an infusion device. The method of claim 28, Casting the material within the sleeve and on top of the plunger where the material returns to a more solid state further comprises casting the correct dosage within the dosing chamber housing in a sterile environment; Method for dosing into an infusion device.

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