BRPI0717517A2 - DISPOSABLE OPHTHALMAL INJECTION DEVICE - Google Patents

Description

Report of the Invention Patent for "DISPOSABLE OPHTHALMAL INJECTION DEVICE".

Related Requests

This application is a continuation in part of US Patent Application No. 11 / 581,629, filed October 16, 2006, US Patent Application No. 11 / 581,630, filed October 16, 2006, US patent application. No. 11 / 581,591, filed October 16, 2006 and US Patent Application No. 11 / 435,906, filed May 17, 2006. Background of the Invention The present invention relates to a medical device for use in

more particularly, a two-piece ophthalmic drug delivery device with a disposable tip end having an improved piston coupling and sealing.

Several diseases and conditions of the posterior segment of the eye threaten vision. Age Related Macular Degeneration (ARMD), Choroidal Neovascularization (CNV), Retinopathies (eg diabetic retinopathy, Vitreoretinopathy), Retinitis (eg cytomegalovirus retinitis (CMV)) - Cytomegalovirus), uveitis, macular edema, glaucoma and neuropathies are several examples.

These and other illnesses can be treated by injecting a drug into the eye. Such injections are typically made manually using a conventional syringe and needle. Figure 1 is a perspective view of a prior art syringe used to inject medicaments into the eye. In Figure 1, the syringe includes a needle 105, a Iuer-type connector shaft 110, a chamber 115, a plunger 120, a plunger shaft 125, and a thumb rest 130. As is commonly known, the medicament to be Injected injection is located in chamber 115. Pushing thumb support 130 causes plunger 120 to expel the medicament through needle 105.

In the use of such a syringe, the surgeon is required to pierce the eye tissue with the needle, hold the syringe firmly and actuate the syringe plunger (with or without the help of a nurse) to inject fluid into the eye. The injected volume is typically not precisely controlled because the syringe barrel is not accurate with respect to the small injection volume. Fluid flow rates are not controlled. Vernier reading is also subject to a parallax error. Tissue damage may occur due to an "unstable" injection. Medication reflux may also occur when the needle is removed from the eye.

An effort has been made to control the delivery of small quantities of liquids. A commercially available fluid dispenser is the ULTRA® Positive Displacement Dispenser, available from EFD Inc., Providence, Rhode Island. The ULTRA dispenser is typically used for dispensing small volumes of industrial adhesives. It uses a standard syringe and a custom dispensing tip. The syringe plunger is actuated using a stepping motor and actuating fluid. Parker Hannifin Corporation, Cleveland, Ohio, distributes a small volume dispenser for drug discovery applications, manufactured by Aurora Instruments LLV, San Diego1 California. The Parker / Aurora dispenser utilizes a piezoelectric dispensing mechanism. Ypsomed, Inc., Switzerland, produces a line of automated injection pens and injectors primarily for a patient's self-injection of insulin or hormones. This product line includes simple disposable pens and electronically controlled motorized injectors.

US Patent No. 6,290,690 describes an ophthalmic system for injecting a viscous fluid (e.g. silicone oil) into the eye while simultaneously aspirating a second viscous fluid (e.g. liquid perfluorocarbon) from the eye into the eye. a fluid / fluid exchange during surgery to repair a retinal tear or tear. The system includes a conventional syringe with a plunger. One end of the syringe is fluidly coupled to a pneumatic pressure source that provides constant pneumatic pressure to actuate the plunger. The other end of the syringe is fluidly coupled to an infusion cannula via a delivery tube for viscous fluid to be injected. It would be desirable to have a portable handpiece for injecting a medicament into the eye that includes a relatively inexpensive nose segment that can be fixed and removed from a reusable assembly. Putting the most costly components, including electronics and drive mechanism, into the reusable assembly, while the components are kept sterile in the nose assembly, increases the efficiency and cost-effectiveness of a power system. medicine delivery. It would be desirable to have a reusable set that contains the functionality and components for the injection process. It would also be desirable to have a disposable tip segment that can be easily attached to the reusable assembly for injection and then easily removed and discarded after injection. Such a system provides numerous benefits over prior art injectors. Summary of the Invention In a manner consistent with the principles of the present

In this invention, the present invention is a disposable injection device having a dispensing chamber housing, a piston, a needle and a temperature control device. The dispensing chamber housing has an inner surface and an outer surface. The inner surface partially defines a dispensing chamber for receiving a quantity of a substance. The plunger is engaged with the inner surface of the dispensing chamber housing, is capable of sliding into the dispensing chamber housing and is fluidly sealed to the inner surface of the dispensing chamber housing. The plunger has a plunger interface. The needle is fluidly coupled to the dispensing chamber. The temperature control device at least partially surrounds the housing of the dispensing chamber and changes a temperature of the substance in the dispensing chamber. The substance is injected after the temperature of the substance is changed.

In another modality consistent with the principles of

In this invention, the present invention is a disposable injection device having a dispensing chamber housing, a plunger, a needle, a temperature control device, a thermal sensor, a pair of interface connectors and a housing. The dispensing chamber housing has an inner surface and an outer surface. The inner surface partially defines a dispensing chamber for receiving a quantity of a substance. The plunger is engaged with the inner surface of the dispensing chamber housing, is capable of sliding into the dispensing chamber housing and is fluidly sealed to the inner surface of the dispensing chamber housing. The plunger has a plunger interface. The needle is fluidly coupled to the dispensing chamber. The temperature control device at least partially surrounds the dispensing chamber housing and changes a temperature of the substance in the dispensing chamber. The thermal sensor is located near the dispensing chamber housing and measures a temperature near the dispensing chamber housing. The pair of interface connectors are located on a disposable injection device interface surface. The housing closes at least partially the dispensing chamber housing and the plunger. The substance is injected after the temperature of the substance is changed.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not intended to provide further explanation of the invention as claimed. The following description, as well as the practice of the invention, establish and suggest further advantages and purposes of the invention. Brief Description of the Drawings The accompanying drawings, which are incorporated and constitute a

part of this report illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention.

Figure 1 is a perspective view of a technical syringe.

previous.

Figure 2 is a view of an ophthalmic medical device that

includes a disposable nose segment and a limited reusable assembly in accordance with one embodiment of the present invention. Figure 3 is another embodiment of a limited reuse assembly in accordance with the principles of the present invention.

Figure 4 is a cross-sectional view of another embodiment of a limited reuse assembly in accordance with the principles of the present invention.

Figure 5 is a cross-sectional view of a disposable nose segment and a limited reuse assembly according to one embodiment of the present invention.

Figure 6 is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention.

Figure 7 is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention. Figure 8 is a cross-sectional view of a segment of

disposable tip and a partial view of a limited reuse assembly according to one embodiment of the present invention.

Figure 9A is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention.

Fig. 9B is an end view of the embodiment of Fig. 9A.

Figures 10A to 10D are schematic illustrations of four different circuits that may be included in embodiments of the present invention.

Figure 11 is an end view of a limited reuse assembly in accordance with the principles of the present invention.

Figure 12 is a cross-sectional view of a limited reuse assembly according to one embodiment of the present invention. Figure 13 is a cross-sectional view of an assembly with

limited reuse according to one embodiment of the present invention.

Figures 14 and 15 are cross-sectional views of two subassemblies according to the principles of the present invention.

Figure 16 is a cross-sectional view of a limited reuse assembly, nose segment and charging base in accordance with the principles of the present invention.

Figures 17A and 17B are flow charts of an injection method.

of a substance in an eye according to the principles of the present invention.

Figure 18 is a flow chart of a method for injecting a substance into an eye according to the principles of the present invention.

Figure 19 is a flow chart of a method for injecting a substance into an eye according to the principles of the present invention.

Figure 20 is a flow chart of a method for injecting a substance into an eye according to the principles of the present invention.

Detailed Description of Preferred Modalities

Now, reference is made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts.

Figure 2 is a view of an ophthalmic medical device including a disposable nose segment and a limited reuse assembly according to one embodiment of the present invention. In Figure 2, the medical device includes a nib segment 205 and a limited reuse assembly 250. Nib segment 205 includes a needle 210, a housing 215, and an optional light 275. The limited reuse assembly 250 includes a housing 255, a switch 270, a locking mechanism 265 and a threaded portion 260. Tip segment 205 may be attached and removed from the housing.

limited reuse assembly 250. In this embodiment, the tip segment 205 has a threaded portion on an internal surface of housing 215 which bolts to the threaded portion 260 of the limited reuse assembly 250. In addition, the locking mechanism 265 holds the tip segment 215 in the limited reuse assembly 250. The locking mechanism 265 may be in the form of a button, a sliding switch or a lever mechanism. Other mechanisms for connecting the tip segment 205 to the limited reuse assembly 250, such as those involving pairing structural features, are commonly known in the art and are within the scope of the present invention.

Needle 210 is adapted to deliver a substance such as

A medicine in an eye. Needle 210 may have any commonly known configuration. Preferably, needle 210 is designed such that its thermal characteristics are conductive to the particular drug delivery application. For example, when a heated drug is to be delivered, the needle 210 may be relatively short (several millimeters) long (for thermal purposes) to facilitate proper delivery of the drug.

Switch 270 is adapted to provide a system input. For example, switch 270 may be used to activate the system or turn on a temperature control device. Other user-controlled switches, buttons, or control inputs are commonly known and may be employed with the limited reuse set 250 and / or the tip segment 205.

Optional light 275 illuminates when nib segment 205 is ready for use. Optional light 275 may project from housing 215 or may be contained within housing 215, in which case optional light 275 may be viewed through a transparent portion of housing 215. In other embodiments, optional light 275 may be be replaced by an indicator, such as a liquid crystal display, segmented display, or other device that indicates a state or condition of the disposable nose segment 205. For example, optional light 275 may pulse to indicate other states, such as, but not limited to, a system error, fully charged battery, insufficiently charged battery, or faulty connection between tip segment 205 and limited use set 250. Although shown on tip segment 205, the optional light 275 or a Optional indicator may be located on limited reuse set 250.

Figure 3 is another embodiment of a limited reuse assembly in accordance with the principles of the present invention. Limited reuse assembly 250 includes a button 308, a monitor 320, and a housing 330. A disposable nose segment 205 connects end 340 of the limited reuse assembly 250. Button 308 is actuated to provide an input to the system. As with switch 270, button 308 can activate a temperature control device or initiate actuation of a piston. The display 320 is a liquid crystal display, segmented display or other device indicating a state or condition of the disposable nose segment 205 or limited reuse assembly 250.

Figure 4 is a cross-sectional view of another embodiment of a limited reuse assembly in accordance with the principles of the present invention. In Figure 4, power source 505, interface 517, actuator 515 and actuator shaft 510 are located in housing 255. The upper part of housing 255 has a threaded portion 260. Locking mechanism 265, the switch 270, button 308 and indicators 306, 307 are all located in housing 255.

The 505 power source is typically a rechargeable battery, such as a lithium ion battery, although other types of batteries may be employed. In addition, any other type of power cell is suitable for power source 505. Power source 505 supplies power to the system, and more particularly to actuator 515. Power supply 505 also supplies power to a segment. connected to the limited reuse assembly 250. In this case, the power supply 505 can supply power to a temperature control device (not shown) located on the nose segment. Optionally, the power source 505 may be removed from housing 255 through a door or other similar item (not shown).

Interface 517 is typically an electrical conductor that allows power to flow from power 505 to actuator 515. Other interfaces, such as interface 517, may also be present to provide power to other parts of the system.

Actuator shaft 510 is connected and driven by actuator 515. Actuator 515 is typically a stepper motor or other type of motor that is capable of moving actuator shaft 510 by precise distances. In one embodiment, the actuator shaft 510 is connected via a mechanical connection to a nose segment that delivers a drug to an eye. In such a case, actuator 515 is a stepping motor that can precisely move shaft 510 to deliver a precise amount of medication to the eye. Actuator 515 is secured to an inner surface of housing 255 by, for example, tabs that engage the outer surface of actuator 515. In other embodiments, actuator 515 is a linear actuator or

linear drive. In such a case, the actuator 515 may be a spring or spring driven mechanism, a direct current motor equipped with a rotary sensor coupled to a linear drive or a direct current motor coupled to a linear drive with a linear sensor or a linear stepper motor. Other types of motors, such as a rotational permanent magnet motor, can also be used for the 515 actuator.

Locking mechanism 265, switch 270, and knob 308 are all located in housing 255 so that they can be handled by hand. Likewise, indicators 306, 307 are located in housing 255 such that they can be seen. Locking mechanism 265, switch 270, knob 308, and indicators 306, 307 are all connected to a controller (not shown) via interfaces (not shown) located in housing 255. Figure 5 is a view in cross section of a segment of

disposable tip and a limited reuse assembly according to one embodiment of the present invention. Fig. 5 shows how nib segment 205 interfaces with limited reuse assembly 250. In the embodiment of Fig. 5, nib segment 205 includes assembly 555, piston interface 420, piston 415, chamber housing 425, the tip segment housing 215, the temperature control device 450, the thermal sensor 460, the needle 210, the dispensing chamber 405, the interface 530 and the tip interface connector 453. limited reuse kit 250 includes the mechanical connection interface 545, the drive shaft 515, the power supply 505, the controller 305, the limited reuse assembly housing 255, the interface 535, and the interface connector of the limited reuse set 553.

In tip segment 205, plunger interface 420 is located at one end of plunger 415. The other end of plunger 415 forms an end of dispensing chamber 405. Plunger 415 is adapted to slide into dispensing chamber 405. A The outer surface of the plunger 415 is fluidly sealed to the inner surface of the dispensing chamber housing 425. The dispensing chamber housing 425 surrounds the dispensing chamber 405. Typically, the dispensing chamber housing 425 is cylindrically shaped. As such, the dispensing chamber 405 also has a cylindrical shape. In nose segment 205, assembly 555 includes any number of components as described below.

The needle 210 is fluidly coupled to the dispensing chamber 405. In such a case, a substance contained in the dispensing chamber 405 may pass through the needle 210 into the eye. The temperature control device 450 at least partially surrounds the housing of the dispensing chamber 425. In this case, the temperature control device 450 is adapted to heat and / or cool the housing of the dispensing chamber 425 and any substance in dispensing chamber 405. Interface 530 connects temperature control device 450 to tip interface connector 453.

Tip segment components 205, including housing of dispensing chamber 425, temperature control device 450, and plunger 415, are at least partially enclosed by tip segment housing 215. In an embodiment consistent with the principles of the present invention, plunger 415 is sealed to the inner surface of the dispenser chamber housing 425. This seal prevents contamination of any substance contained in the dispenser chamber 405. For medical purposes, such a seal is desirable. This seal can be located anywhere on plunger 415 or dispensing chamber housing 425.

In the limited reuse assembly 250, power supply 505 provides power to actuator 515. An interface (not shown) between power supply 505 and actuator 515 serves as a conduit for powering actuator 515. Actuator 515 is connected to actuator shaft 510. When actuator 515 is a stepper motor, actuator shaft 510 is integral with actuator 515. Mechanical linkage interface 545 is connected to actuator shaft 510. In this configuration , as actuator 515 moves actuator shaft 510 upwards toward needle 210, mechanical linkage 545 also moves upwards towards needle 210. In other embodiments of the present invention, the interface of mechanical linkage 545 and actuator shaft 510 are a single component. In other words, an axis connected to actuator 515 includes both actuator axis 510 and mechanical linkage interface 545 as a single assembly.

The controller 305 is connected via interface 535 to the limited reuse set interface connector 553. The limited reuse set interface connector 553 is located on a top surface of the adjacent limited reuse set housing 255. to the mechanical interface 545. In this way, both the limited reuse set interface connector 553 and the mechanical interface 545 are adapted to be connected to the tip interface connector 453 and plunger interface. 420, respectively.

Controller 305 and actuator 515 are connected by an interface (not shown). This interface (not shown) allows controller 305 to control the operation of actuator 515. In addition, an interface (not shown) between power supply 505 and controller 305 allows controller 305 to control operation of the power supply. In such a case, the 305 controller can control the loading and unloading of the 505 power supply to the 505 power supply for a rechargeable battery.

Controller 305 is typically an integrated circuit with power, input, and output pins capable of performing logic functions. In several embodiments, controller 305 is a target device controller. In such a case, the 305 controller performs specific control functions directed at a specific device or component, such as a temperature control device or a power supply. For example, the temperature control device controller has the basic functionality to control a temperature control device. In other embodiments, the controller 305 is a microprocessor. In such a case, the controller 305 is programmable such that it can function to control more than one component of the device. In other cases, the 305 controller is not a programmable microprocessor, but instead is a special purpose controller configured to control different components that perform different functions. Although illustrated as a component in FIG. 5, controller 305 can be made of many different components or integrated circuits.

Tip segment 205 is adapted to match or attach to the limited reuse assembly 250. In the embodiment of Figure 5, plunger interface 420 located on a bottom surface of plunger 415 is adapted to correspond to mechanical link interface 545 loca. - located near a top surface of the limited reuse assembly housing 255. In addition, the nib interface connector 453 is adapted to connect to the limited reuse assembly interface connector 553. When the segment No. 205 is connected to the limited reuse assembly 250 in this manner, actuator 515 and actuator shaft 510 are adapted to drive piston 415 upwardly towards needle 210. In addition, an interface is formed between controller 305 and actuator 305. temperature control device 450. A signal can be passed from controller 305 to temperature control device 450 via interface 535, 553 limited reuse set interface connector, 453 edge interface connector, and 530 interface connector.

In operation, when nose segment 205 is connected to limited reuse assembly 250, controller 305 controls the operation of actuator 515. When actuator 515 is actuated, actuator shaft 510 is moved upward toward needle 210. In turn, the mechanical interface 545, which corresponds to the piston interface 420, moves the piston 415 up towards the needle 210. A substance located in the dispensing chamber 405 is then expelled through the needle 210.

In addition, the controller 305 controls the operation of the temperature control device 450. The temperature control device 450 is adapted to heat and / or cool the housing of the dispensing chamber 425 and its contents. Since the dispensing chamber housing 425 is at least partially thermally conductive, heating or cooling of the dispensing chamber housing 425 heats or cools a substance located in the dispensing chamber 405. Temperature information can be transferred from the thermal sensor 460 via the interface. 530, tip interface connector 453, limited reuse set interface connector 553 and interface 535 back to controller 305. This temperature information can be used to control the operation of the temperature control device 450. When the device temperature control unit 450 is a heater, controller 305 controls the amount of current that is sent to the temperature control device 450. The more current is sent to the temperature control device 450, the warmer it is. stay. Thus, the 305 controller may use a feedback loop that uses information from the thermal sensor 460 to control the operation of the temperature control device 450. Any suitable type of control algorithm, such as a proportional integral derivative algorithm ( PID), can be used to control the operation of the 450 temperature control device.

Figure 6 is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention. In Figure 6, the disposable tip segment 205 includes housing 215, needle 210, plunger 415, piston interface 420, dispensing chamber 405, dispensing chamber housing 425, assembly 555, temperature control device 450, thermal sensor 460, optional Iuer-type connector 430, nose interface connectors 451, 452 and 453, and interfaces 461, 462 and 463. Disposable nose segment 205 operates as a device disposable injection

In the embodiment of Fig. 6, plunger 415 is located in the housing of dispensing chamber 425. Dispensing chamber 405 is surrounded by housing of dispensing chamber 425 and plunger 415. Plunger 415 forms a fluid seal with the inner surface of the dispenser. dispensing chamber housing 425. Needle 210 is fluidly coupled to dispensing chamber 405. In this manner, a substance located in dispensing chamber 405 can be contacted by plunger 415 and pushed out of needle 210. Needle 210 it may be secured to the disposable tip segment 205 by an optional Iuer-type connector 430 or may be permanently attached. The temperature control device 450 is located in the dispensing chamber housing 425 and at least partially surrounds the dispensing chamber 405. The housing 215 forms an outer skin on the disposable tip segment 205. In various embodiments of the present invention, the device in

temperature control 450 is a heating and / or cooling device. The temperature control device 450 is in thermal contact with the housing of the dispensing chamber 425. As such, the temperature control device 450 is capable of changing the temperature of the substance in the dispensing chamber 405.

In Figure 6, plunger 415 includes an O-ring. The O-ring seals against an inner surface of the dispenser chamber housing 425. In this manner, a sterile seal is maintained, thus preventing contamination of the substance in the dispensing chamber 405. The piston 415 may be made of any suitable material such as glass, stainless steel or a polymer. The O-ring is typically made of rubber or a polymer. Other types of seals can also be used. For example, piston 415 may contain a ring which is located around the periphery of piston 415 such that the ring contacts the inner surface of the dispensing chamber 425. This ring may seal the piston against the inner surface of the dispensing chamber 425. In such a case, the ring may be integral with piston 415 and piston 415 may be made of rubber or polymer. Piston interface 420 may be of any suitable shape. For example, the plunger interface may be substantially shell shaped as shown, or may be substantially flat, conical or spherical. It may also include a ferrule or other similar feature.

Tip interface connectors 451, 452, and 453 serve to provide a connection between tip segment 205 and a limited reuse assembly. Interface 461 connects thermal sensor 460 to nipple interface connector 451. Interface 462 connects temperature control device 450 to nipple interface connector 452. Interface 463 connects assembly 555 to interface connector tip 453.

The 555 set may include any of a number of different components. In one embodiment, assembly 555 contains a fuse that is extended when the heat button is activated or after disposable tip segment 205 is used. In this way, the fuse prevents reuse of the disposable tip segment 205. In another embodiment, the 555 assembly includes a memory device that stores information about the disposable tip segment type 205, dosage information, temperature, plunger movement information, or any other information identifying a feature of the disposable tip segment 205 or a manner in which the disposable tip segment 205 is operated. In other embodiments, assembly 205 includes a wired memory device such as NAND flash IC, RFID marker, wired circuit that can store a data representation, such as a series of fuses and resistors connected in parallel or another type of device.

A substance to be delivered to an eye, typically a

dispenser chamber 405. In this manner, the medicament is contacted by the inner surface of the dispenser chamber housing 425 and a face of the piston 415. The temperature control device 450 is in thermal contact with the dispense chamber housing. In this way, the temperature control device 450 is adapted to control the temperature of the contents of the dispensing chamber 405.

In various embodiments of the present invention, the temperature control device 450 heats a phase transition compound which is located in the dispensing chamber 405. This phase transition compound carries a medicament that is to be injected into the eye. A phase transition compound is a solid or semi-solid state at lower temperatures and a more liquid state at higher temperatures. Such a substance may be heated by the temperature control device 450 to a more liquid state and injected into the eye, where it forms a bolus that erodes over time. Similarly, a reverse gelling compound may be used. An inverse gelling compound is in a solid or semi-solid state at higher temperatures and in a more liquid state at lower temperatures. Such a compound may be cooled by the temperature control device 450 to a more liquid state and may be injected into the eye, where it forms a cake that erodes over time. As such, the temperature control device 450 may be a device that heats a substance in the dispensing chamber 405 or a device that cools a substance in the dispensing chamber 405 (or a combination of both). Upon delivery to the eye, a phase transition compound or reverse gelling compound erodes over time, providing a quantity of drug over an extended period of time. Using a phase transition compound or reverse gelling compound provides a better dosage of the drug with fewer injections.

Thermal sensor 460 provides temperature information to assist in controlling the operation of temperature control device 450. Thermal sensor 460 may be located near the dispensing chamber housing 425 and measures a temperature near the dispensing chamber housing 425. The thermal sensor 460 may also be located in thermal contact with the dispensing chamber housing 425, in which case it measures a temperature of the dispensing chamber housing 425. In other embodiments, the temperature that the thermal sensor 460 measures may correlate with the temperature of the substance in the dispensing chamber 405. In other words, a measurement of the dispensing chamber 425 temperature can be used to calculate the temperature of the substance located in the dispensing chamber 405. Like the thermal characteristics of the dispensing chamber housing 425 and the substance thereof are known, and the temperature of the temperature control device 450 is controllable, an application of the temperature control device for a specified period of time results in a calculated change in substance temperature in dispensing chamber 405. Thermal sensor 460 can be any of series of different devices that can provide temperature information. For example, thermal sensor 460 may be a thermocouple or resistive device whose resistance varies with temperature.

In one embodiment of the present invention, the substance located in the dispensing chamber 405 is a medicament which is preloaded in the dispensing chamber. In such a case, disposable tip segment 205 is suitable as a single use consumable product. Such a disposable product may be assembled in a factory with a dosage of one drug installed.

When a medicine is preloaded into the dispensing chamber,

405, a certain amount of the medicament may be preloaded. For example, 100 microliters of a drug may be loaded into the dispensing chamber 405 and any amount up to 100 microliters may be dispensed. Drug quantity information in dispensing chamber 205 and other dosage information can be stored in kit 555. In such a case, plunger 415 can be moved a precise distance to deliver an accurate dosage of medication from from the dispensing chamber 405 through needle 210 to one eye. This provides dosing flexibility and ease of assembly.

Figure 7 is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention. In Figure 7, the disposable tip segment 205 includes housing 215, needle 210, plunger 415, plunger interface 420, dispensing chamber 405, dispensing chamber housing 425, assembly 555, 450 temperature control device, the 460 thermal sensor, the optional Iuer-type connector 430, the 452 and 453 nose interface connectors, the 462 and 463 interfaces, and the 471 locking mechanism.

The embodiment of FIG. 7 functions as the embodiment of FIG. 6. The various components of the nose segment 205 of FIG. 7 have the same characteristics and operate in substantially the same manner as the components of FIG. 6. The locking mechanism 471 serves to secure the tip segment 205 to limited reuse set. A matching mechanism, such as lock mechanism 265, in a limited reuse assembly, attaches to lock mechanism 471 and secures nose segment 205 to a limited reuse assembly.

Figure 8 is a cross-sectional view of a disposable nose segment and a partial view of a limited reuse assembly according to one embodiment of the present invention. In Figure 7, disposable tip segment 205 includes housing 215, needle 210, plunger 415, plunger interface 420, dispensing chamber 405, dispensing chamber housing 425, RFID tag 1110, temperature control device 450, edge interface connector 452 and interface 462. Partial view of a limited reuse assembly illustrates mechanical linkage interface 545, actuator shaft 510, interface 535, interface connector 552 limited reuse set, the 1120 RFID reader and the 1130 RFID interface.

The embodiment of FIG. 8 functions as the embodiments of FIGS. 6 and 7. The various components of nose segment 205 of FIG. 8 have the same characteristics and operate in substantially the same manner as the similar components of FIGS. The embodiment of Figure 8 uses an RFID system instead of a wired set 555 to store and transfer information. The 1120 RFID reader is located near the top of a limited reuse assembly adjacent to the 545 mechanical link interface. The RFID marker is located at the bottom of tip segment 205. The 1120 RFID reader is designed to read information from the RFID tag 1110. Interface 1130 connects to controller 305 (not shown).

RFID tag 1110 is configured to hold the same type of information as set 555 can hold in the embodiments of FIGS. 5 through 7. In this way, RFID tag 1110 is another type of memory. However, as is commonly known, the RFID 1110 tag does not require a wired connection to the RFID 1120 reader. In this way, a wireless connection can be established between tip segment 205 (RFID 1110 tag) and a limited reuse set (limited reuse reader 1120).

In one type of RFID system, a passive RFID system, the RFID tag 1110 does not have a power supply. Instead, the passive RFID tag relies on the electromagnetic field produced by the RFID 1120 reader for its supply. The electromagnetic field produced by the RFID 1120 reader and emitted by the RFID reader antenna (not shown) induces a small electrical current in the RFID 1110 marker. This small electrical current allows the RFID 1110 marker to operate. In this passive system, the RFID marker is designed to collect energy from the electromagnetic field emitted by the RFID 1120 reader and to transmit a long range signal that is received by the RFID 1120 reader.

In operation, the RFID reader antenna (not shown) transmits a signal produced by the RFID reader 1120. The RFID marker antenna (not shown) receives this signal and a small current is induced in the RFID marker 1110. This small current energizes the marker. RFID 1110. The RFID tag 1110 can then transmit a signal through its RFID tag antenna to the RFID reader antenna and the RFID 1120 reader itself. In this way, the RFID 1110 marker and the RFID 1120 reader can be combined. report on a radio frequency call. The RFID tag 1110 transmits information, such as dosage information or tip segment information, through the RFID tag antenna to the RFID reader 1120. This information is received by the RFID reader 1120. In this way, the information can be transferred from the segment. nozzle 205 for limited reuse set. The RFID reader 1120 can transmit information to the RFID marker 1110 in a similar manner. For example, the RFID 1120 reader may transmit information such as dosage information on the radio frequency signal emitted by the RFID 1120 reader. The RFID 1120 marker receives this radio frequency signal with the information. Then the RFID tag 1110 can store this information.

Although the embodiment of FIG. 8 is described as having an RFID system, any other type of wireless system may be used to transfer information between a limited reuse set 250 and end segment 205. For example, a Bluetooth protocol may be used. - to establish a communications link between a limited reuse set 250 and end segment 205. Then, the information may be transferred between a limited reuse set 250 and a tip segment 205 in this communication link. Other modalities used to transfer information include an infrared, 802.11, fire wire, or other wireless protocol.

In one embodiment, RFID tag 1110 (or assembly 555) contains dosage information. Information on an appropriate drug dosage for a drug contained in dispensing chamber 405 may be contained in RFID marker 1110 (or assembly 555). In such a case, the controller 305 may read the dosage information from the RFID marker 1110 (or assembly 555) and operate the actuator 515 appropriately to deliver the appropriate dosage. For example, 100 microliters may be contained in dispensing chamber 405. Information stating that a dosage of 20 microliters must be delivered to an eye may be stored in RFID marker 1110 (or set 555). In such a case, the controller 305 reads the dosage information (which should be delivered 20 microliters to the eye) of the RFID 1110 marker (or assembly 555). Controller 305 can then operate actuator 515 to deliver a dosage of 20 microliters. Controller 305 can cause actuator 515 to move actuator shaft 510 and mechanical linkage interface 545 for a set distance related to a dosage of 20 microliters. In such a case, the piston 415 is moved by this defined distance such that only 20 microliters of a medicament is expelled from needle 210 in one eye.

In another embodiment consistent with the principles of the present invention, controller 305 may calculate a distance by which piston 415 must be moved to deliver the desired dosage. For example, if the dosage information corresponding to a 20 microliter drug dosage was read from the RFID marker 1110 (or set 555) by controller 305, then controller 305 can use this information to calculate an appropriate distance by which the plunger 415 has to be moved. As the volume of dispensing chamber 405, as well as the volume of a drug loaded in dispensing chamber 405, is known, a distance by which plunger 415 has to be moved to deliver the required dosage can be calculated by controller 305. When the dispensing chamber 405 is cylindrical in shape, the volume of the dispensing chamber may be calculated using the cross-sectional area of the cylinder (the area of a circle) times the height of the dispensing chamber. This simple mathematical formula can be used to calculate the total volume of dispenser chamber 405. Since the cross-sectional area of dispenser chamber 405 is constant for any given application, the height corresponding to a distance by which piston 415 travels can be calculated for any dosage amount. For example, assume that 100 microliters of a drug is loaded into the dispensing chamber 405 and that the cross-sectional area of the dispensing chamber 405 is 10. When the dispensing chamber 405 is shaped like a cylinder, the height of that cylinder is also 10. In order to deliver a 20 microliter dosage which corresponds to 20% of the total volume of the dispensing chamber 405, it is necessary to move the plunger 415 upwardly towards the needle 210 by a distance of two. In other words, a dosage of 20 microliters corresponds to 20% of the total volume of dispensing chamber 405. In such a case, plunger 415 should be moved upwardly towards needle 210 by a distance equal to 20% of the total height of the dispenser. dispensing chamber 405. Then, controller 305 can control actuator 515 such that actuator shaft 415 drives plunger 415 upward by 20% of the total height of dispensing chamber 405.

In addition, the 305 controller can read information about a

rate at which plunger 415 must be moved to properly deliver a dosage of drug. In such a case, controller 305 reads information about the drug delivery rate from RFID marker 1110 (or assembly 555) and uses that information to operate actuator 515 to drive piston 415 at that rate. The rate at which the piston 415 moves may be fixed or may be variable. In some applications it may be desirable to move the plunger 415 faster than in other applications. For example, when the drug contained in the dispensing chamber 405 is a drug that must be heated before being injected into an eye, it may be desirable to actuate the plunger 415 at a rate such that the heated drug does not cool and clog the needle 210. In other applications, it may be desirable to move the plunger 415 slowly to improve delivery of a drug contained in the dispensing chamber 405.

RFID tag 1110 (or assembly 555) may also include any other type of drug delivery related information. For example, RFID tag 1110 (or assembly 555) may include information about the type of drug contained in dispensing chamber 405, various characteristics of that drug, or other characteristics of a suitable dosage or delivery of that drug. In addition, the RFID tag 1110 (or assembly 555) may contain safety information, information about proper operation of tip segment 205, or any other information related to tip segment or limited reuse set.

In another embodiment consistent with the principles of the present invention, the medical professional administering the drug may select a dosage. In such a case, an inlet device (not shown) located in the limited reuse assembly 250 or tip segment 205 may allow a physician to select the desired dosage of drug. In such a case, controller 305 receives the desired drug dosage and operates actuator 515 to move the plunger 415 the required distance to deliver the desired dosage. Such user selectable dosing scheme can be implemented simply by adding an extra input device.

It may be desirable to include dosage information in the RFID tag 1110 (or assembly 555) such that a dosage error is less likely to occur. In such a case, a series of different drug delivery tip segments 205 may be manufactured and loaded with a drug at the factory. Dosing information can also be loaded on the RFID 1110 tag (or set 555) at the factory. In such a case, a series of different nose segments, each with the same amount of drug contained in the dispensing chamber 405, but with different dosage information stored in the RFID marker 1110 (or set 555), may be manufactured and transported. Then, a physician may order tip segment 205 with the required dosage information on RFID marker 1110 (or set 555). The package may be labeled to identify dosage information such that the appropriate dosage is administered to a patient.

Figure 9A is a cross-sectional view of a disposable nose segment for an ophthalmic medical device according to an embodiment of the present invention. In Figure 9, the disposable tip segment 205 includes the housing 215, the needle 210, the piston 415, the piston shaft 417, the piston interface 420, the dispenser chamber 405, the dispenser chamber housing 425 , the 555 set, the 450 temperature control device, the 460 thermal sensor, the optional Iuer-type connector 430, the tip interface connectors 452 and 453, the interfaces 462 and 463, and the tabs 472 and 473.

The various components of the nib segment 205 of FIG. 9 have the same characteristics and operate in substantially the same manner as the similar components of FIGS. 5 to 8. The embodiment of FIG. 9 includes two tabs 472 and 473 that engage slots in a limited reuse set. After these two tabs 472 and 473 are inserted into the slings, the tip assembly 205 is rotated to lock into place in a limited reuse assembly. The two tabs 472 and 473 may have different shapes or sizes to provide a suitable interface between the tip segment 205 and a limited reuse assembly. When these two tabs 472 and 473 are shaped or sized differently, then the tip segment 405 only fits into a limited reuse assembly in one orientation. In other embodiments of the present invention, differently shaped or sized tabs may be used with differently shaped or sized slots in different limited reuse sets. In this way, it is possible to manufacture a series of different limited reuse assemblies with different shaped and sized slots to accommodate the nib segments 205 with complementary shaped or sized tabs.

In addition, the embodiment of figure 9 includes a plunger shaft 417 which is connected to plunger 415. In this embodiment, plunger 415 may be overmolded on plunger shaft 417. Plunger shaft 417 is generally cylindrical in shape with a diameter in the middle that is smaller than a diameter at its distal and proximal ends. Piston interface 420 is a surface at the proximal end of piston shaft 417. Piston shaft 417 is typically made of a rigid material such as stainless steel. Piston 415 is made of a rubber or polymer material. In another embodiment of the present invention, the distal end of shaft 417 has a ferrule to which plunger 415 may be applied. The piston 415 can be snap-fitted to the piston shaft 417 and is held in place by a ferrule at the distal end of the piston shaft 417. This makes it easier to mount. Instead of shaping piston 415 over an axis, piston 415 may be manufactured as a separate portion and pushed onto the distal end of piston shaft 417. Piston interface 420 may be of any suitable shape.

Figure 9B is an end view of the tip segment of Figure 9A. Figure 9B illustrates the end of the farthest tip segment 205 from needle 210. This end interfaces with a limited reuse assembly. Housing 215, plunger interface 420, nose interface connectors 451, 452, 453, 454, 455 and 456, tabs 472 and 473 and alignment slot 481 are shown.

In the embodiment of Fig. 9B, one end of the plunger interface 420 is not completely circular. It has a flat portion that is designed to align with a mechanical bonding interface with a similar cross-sectional shape. This optional feature is designed to allow proper alignment of a nose segment and a limited reuse set. In other embodiments of the present invention, the cross-sectional view of one end of the plunger interface 420 is circular.

The embodiment of Fig. 9B also includes an optional alignment slot 481 to help properly align a nose segment with a limited reuse assembly. Alignment slot 481 interfaces with an alignment pin in a limited reuse assembly (581 as shown in Figure 11). In another embodiment of the present invention, tabs 472 and 473 have different sizes. Alternatively, tabs 472 and 473 may have different shapes. The two tabs 472 and 473 also help align a nose segment with a limited reuse assembly by interfacing with slots 572 and 573 of Figure 11.

In an embodiment consistent with the principles of the present invention, a nose segment is placed in a limited reuse assembly such that tabs 472 and 473 are inserted into slots 572 and 573. Then, the nose segment is rotated with respect to to the limited reuse assembly such that the tabs 472 and 473 are retained in slots 572 and 573. Alignment pin 581 and alignment slot 481 are then properly aligned.

The 451, 452, 453, 454, 455, 456 connectors electrically connect one end segment to a limited reuse assembly. Connectors 451, 452, 453, 454, 455, 456 interface with similar connectors 551, 552, 553, 554, 555, 556, respectively, in a limited reuse assembly (as shown in Figure 11). These connectors provide a path for signals to pass between a tip segment and a limited reuse set.

Figures 10A to 10D are schematic illustrations of four different circuits that may be included in embodiments of the present invention. Figure 10A shows one of many different configurations for temperature control device 450. In figure 10A, temperature control device 450 is connected to connectors 452 and 453. Control and / or power signals are provided. to the temperature control device via connectors 452 and 455.

Figure 10B shows one of many different configurations for thermal sensor 460. In figure 10B, thermal sensor 460 is connected to connectors 451 and 454. Signals are received from thermal sensor 460 through connectors 451 and 454.

Figure 10C shows one of many different configurations for a fuse 1011. Fuse 1011 may be contained in assembly 555 or may be implemented as shown in figure 10C. In Figure 10C, fuse 1011 is connected between connectors 453 and 456. In this embodiment, fuse 1011 acts to ensure that the nose assembly is a single use device. Fuse 1011 blows when the heat button is activated or after disposable tip segment 205 is used. As discussed, a controller in a limited reuse set detects when the connected tip segment has been used and causes increased current to pass through the fuse 1011, thereby blowing the fuse. When fuse 1011 is blown, the tip segment is no longer operable and must be discarded.

Figure 10D shows one of many different configurations for set 555. In figure 10D, set 555 is connected to connectors 453 and 456. Power and / or control signals are supplied to set 555 through connectors 453 and 456

Many other configurations of 451, 452, 453, 454, 455, 456 connectors can be implemented. For example, although six connectors are shown, any number of connectors can be implemented. Additionally, any combination of different circuits may be contained in one end segment.

Figure 11 is an end view of a limited reuse assembly in accordance with the principles of the present invention. The end of the limited reuse assembly shown in Fig. 11 interfaces with the end of the nose assembly shown in Fig. 9B. The end view of the limited reuse assembly illustrated in Figure 11 shows the housing 255, the mechanical link interface 545, the limited reuse assembly interface connectors 551, 552, 553, 554, 557 and 556, slots 572 and 573 and alignment pin 581.

In the embodiment of Figure 11, one end of the mechanical interface 545 is not completely circular. It has a flat portion that is designed to align with a plunger interface with a similar cross-sectional shape. This additional feature is designed to allow proper alignment of a nose segment and a limited reuse set. In other embodiments of the present invention, the cross-sectional view of one end of the mechanical interface 545 is circular.

The embodiment of Fig. 11 also includes an optional alignment slot 581 to help properly align a nose segment with a limited reuse assembly. Alignment pin 581 interfaces with an alignment slot in a nose segment (481 as shown in Figure 9B). In another embodiment of the present invention, slots 572 and 573 have different sizes. Alternatively, slots 572 and 573 may have different shapes. The two slots 572 and 573 also help align a nose segment with a limited reuse assembly by interfacing with tabs 472 and 473 of the nose segment shown in Figure 9B. The connectors 551, 552, 553, 554, 557 and 556 electrically connect

has a high end segment to a limited reuse set. Connectors 551, 552, 553, 554, 557, and 556 interface with connectors 451, 452, 453, 454, 455, 456 in one end segment (as shown in Figure 9B). These connectors provide a path for signals to pass between a tip segment and a limited reuse set.

Figure 12 is a cross-sectional view of a limited reuse assembly according to one embodiment of the present invention. In Figure 12, the limited reuse assembly 250 includes the mechanical linkage interface 545, the actuator shaft 510, the actuator 515, the power supply 505, the controller 305, the limited reuse assembly housing 255, interface 535, limited reuse set interface connector 551, displacement sensor 1215, power supply controller 444, and inductor element 1225.

The displacement sensor 1215 measures the movement of the drive shaft 510. The displacement sensor can be, among other things, an optical rotary encoder, a linear encoder, a current sensor circuit (Hall sensor), a potentiometer. rotary switch or a linear potentiometer. In other embodiments, the displacement sensor is capable of detecting if the actuator 515 fails. For example, the Hall sensor can detect a larger current drain by actuator 515, which indicates a fault condition. The displacement sensor 1215 can also measure actuator EMF 515. The displacement sensor 1215 may comprise a single component or multiple components. In an embodiment consistent with the principles of the present invention, the displacement sensor 1215 includes a device for measuring the distance by which the actuator shaft 510 travels and a device for detecting if actuator 515 has stalled.

The travel sensor 1215 measures the position of the actuated

510. Since the mechanical connecting interface 545 is connected to the drive shaft 510, the displacement sensor 1215 also measures its position. Such a displacement sensor 1215 may be used to determine if a full dosage is delivered. If the displacement sensor 1215 detects that the actuator shaft 510 has moved a certain distance corresponding to a movement of the mechanical interface 545 and the piston 415, then it is known that a certain dosage has been expelled by the needle 210. In which case the drug is to be delivered to an eye, the displacement sensor 1215 provides information about the movement of the actuator shaft 510 that can be used to determine if the full dosage has been delivered.

In some cases, actuator 515 may stall, and cannot drive actuator shaft 510, mechanical linkage interface 545, and piston 415 at the appropriate distance to deliver a full dosage of a drug in one eye. In such a case, the displacement sensor 1215 measures the distance by which the actuating geometry axis 510, the mechanical connecting interface 545 and the piston 415 have moved. From this distance information, a delivered amount of drug can be calculated. For example, when the dispensing chamber 405 is cylindrical in shape, its circular cross-sectional area is known. The distance measured by the travel sensor 1215 is then taken from the cylinder height and the travel volume can be easily calculated (by controller 305, for example). This delivered quantity can be communicated with a fault indication via a display such as display 320 (figure 3).

The displacement sensor 1215 may also provide other useful information in the drug delivery process. For example, when a nose segment is connected to a limited reuse assembly, the actuator shaft 510 may be removed or brought into a housed position for connection of a nose segment. The displacement sensor 1215 can measure the movement of the actuator shaft 510 to this housed position. The drive shaft 510 may be placed in a stowed position to allow a nose segment to be attached to a limited reuse assembly or prior to delivery of a drug. In one embodiment, the information read by displacement sensor 1215 is used to confirm that actuator shaft 510 is in a lodged position before actuator 515 is activated to deliver a drug to the eye.

The embodiment of Fig. 12 also includes power supply controller 444 and inductor element 1225. These two components control charging of power supply 505 when power supply 505 is, for example, a rechargeable battery. The 444 power supply controller includes the circuitry that can perform any function related to loading, monitoring and maintenance of the 505 power supply. In other embodiments, the 444 power supply controller may be implemented in or integrated into the power supply. controller 305.

In one embodiment of the present invention, the power supply controller 444 (or controller 305, as the case may be) counts the number of times the limited reuse assembly 250 has been used. After the count has reached a predetermined safe number of uses, the limited reuse set 250 is inactive. Alternatively, power supply controller 444 (or controller 305, as appropriate) counts the number of times power supply 505 has been charged (the number of charge cycles at which power supply 505 has been charged). submitted). When the count reaches a predetermined limit, the limited reuse set 250 is inactive. In other embodiments of the present invention, the power supply controller 444 (or controller 305, as the case may be) detects faulty or other unsafe conditions of the power supply 505 and prevents further use of the limited reuse assembly 250.

To charge the power supply 505, a current is induced in the inductor element 1225 when it is placed near another inductor element in a charging base (not shown). This induced current charges the power supply 505.

Figure 13 is a cross-sectional view of a limited reuse assembly according to one embodiment of the present invention. In Figure 12, the limited reuse assembly 250 includes the mechanical linkage interface 545, the actuator shaft 510, the actuator 515, the power supply 505, the controller 305, the limited reuse assembly housing 255, interface 535, Limited Reuse Set interface connector 551, travel sensor 1215, power supply controller 444, and charging contacts 1235.

In the embodiment of Figure 13, the 1235 contacts interface with the contacts on a charging cradle (not shown) to provide power to the 505 power supply. In one embodiment, the 1235 contacts are a USB type connection such as those used. portable electronic devices with base stations. In one embodiment, a Molex® CradleCon® connector is employed. Other types of connectors may also be used.

Figures 14 and 15 are cross-sectional views of two subsets according to the principles of the present invention. Each of these subsets illustrates the path from actuator 515 to needle 210. Figure 14 illustrates a mechanical linkage interface 545 which is rigidly connected to the actuator shaft 510, while figure 15 illustrates a mechanical linkage assembly 545 with a ball joint 805. Using the ball joint 805 helps align the mechanical interface 545 with the piston interface 420.

In Figure 14, actuator 515 has an actuator shaft 510 which is rigidly connected to mechanical linkage interface 545. The mechanical linkage interface corresponds to plunger interface 420. Plunger 415 is disposed within the housing of the dispensing chamber 425 and is sealed against an inner surface of the dispensing chamber housing 425. The dispensing chamber 405 is limited by an internal surface of the dispensing chamber housing 425 and the distal face of the piston 415. The temperature control device 450 at least partially surrounds the dispensing chamber housing 425. Needle 210 is fluidly coupled to the dispensing chamber 405.

In Figure 15, actuator 515 has an actuator shaft 510 which is

connected to shaft 810 via a ball joint. The mechanical connecting interface 545 is rotatably connected to the shaft 810 via ball joint 805. The mechanical connecting interface pairs with the piston interface 420. The piston 415 is disposed within the dispensing chamber housing 425 and is sealed against an inner surface of the dispensing chamber housing 425. Dispensing chamber 405 is limited by an inner surface of the dispensing chamber housing 425 and the distal face of plunger 415. Temperature control device 450 surrounds at least partially. the housing of the dispensing chamber 425. Needle 210 is fluidly coupled to the dispensing chamber 405.

In figures 14 and 15, actuator 515 drives actuator shaft 510 upward (toward needle 210). In turn, the mechanical interface 545 is also driven upwards. When the mechanical interface 545 is paired with the piston interface 420, the piston 420 is also moved upwards. A substance contained in the dispensing chamber 405 is expelled through the needle 210. In this manner, movement and force is transferred from the actuator shaft 510 to the mechanical connecting interface 545 to the piston 415.

When dispensing chamber 405 contains a drug to be delivered to an eye, the configurations of figures 14 to 15 eliminate reflux when the needle is removed from the eye. The movement of plunger 415 is in one direction only (one direction that expels the drug into the dispensing chamber 405). When the mechanical interface 545 is moved in a direction away from needle 210, for example, after the drug has been injected into the eye, the plunger 415 remains in place. Since the plunger 415 is not rigidly connected to the mechanical interface 545, the plunger 415 is not retracted as the mechanical interface 545 is retracted.

Fig. 16 is a cross-sectional diagram of the limited reuse assembly of Fig. 13 and a loading base. In Figure 16, a bottom surface of the limited reuse assembly 250 interfaces with the charging base 1615. When the limited reuse assembly 250 is resting on the charging base 1615, power supply 505 may be charged. After loading, the limited reuse assembly 250 may be removed from the charging base 1615. In one embodiment of the present invention, the limited reuse assembly 250 with a fixed tip segment 205 is placed on the charging base 1615. and a substance located in the dispensing chamber 405 is heated or cooled by the temperature control device 450. In this way, the charging base 1615 supplies the power to the temperature control device 450. When the substance located in the dispensing chamber 405 has Once the proper temperature has been reached (as determined by the thermal sensor information 460), the limited reuse assembly 250, the fixed tip segment 205 can be removed from the charging base. This saves the power supply 505 for the injection process when the limited reuse assembly 250 and fixed tip segment 205 are removed from the charging base 1615.

Figures 17A and 17B are flow charts of a method of injecting a substance into an eye according to the principles of the present invention. In 1705, a connection between a high end segment and a limited reuse set is recognized. In 1710, the type of point segment that was connected to the limited reuse set is identified. For example, a drug delivery tip segment or type of drug delivery tip segment may be identified. Such identification can occur by reading edge segment information, for example by reading information from the memory or RFID marker. In 1715, dosage information is received from the tip segment. Like tip segment information, dosage information can be read by a controller, an RFID reader, or similar device from a tip segment memory device in the limited reuse set.

In 1720, the temperature control device is activated to change the temperature of the substance that is located in the dispensing chamber. The substance may be heated or cooled as previously described. In addition, heating or cooling can only occur when the nose segment and limited reuse assembly are located on a charging base. In 1725, temperature information is received from a thermal sensor that is located near the dispensing chamber in which the substance is located. In 1730, this temperature information is used to control the temperature control device to regulate the temperature of the substance.

In 1735, the actuator shaft is moved to a lodged position. For example, the actuator shaft may be fully retracted to establish a lodged position. The housed position can set a reference point for a displacement sensor. In other words, the displacement sensor can begin to measure the movement of the actuator shaft from the lodged position. In 1740, the actuator shaft is moved until the mechanical connection interface (which is integral with or connected to the actuator shaft) contacts the piston interface. In this position, any further movement of the actuator shaft results in expulsion of the substance from the dispensing chamber. When the mechanical interface is in contact with the plunger interface, the device is ready to be used to inject the substance into the eye. This step is performed before injecting the substance into the eye so that the substance can be kept at a temperature suitable for injection. For example, the substance may be heated or cooled while the nose segment and limited reuse assembly are located on a loading base. When the tip segment and limited reuse set are removed from the charging base, the physician may have a limited time to perform the injection before the substance temperature drops outside the appropriate temperature range. Having the mechanical connection interface in contact with the piston interface allows an injection to be performed in a short period of time.

In 1745, an entry is received indicating that the substance should be delivered to the eye. For example, the physician may press a button that sends a signal to the controller indicating that the actuator must be activated to deliver the substance. In 1750, dosing information is used to control actuator operation to deliver proper dosing at the appropriate rate. The substance is delivered to the eye only after it is in the appropriate temperature range. In 1755, information is received from the displacement sensor. This information indicates how far the actuator shaft has moved. The distance by which the actuator shaft has moved correlates to a dosage. The further the shaft has moved, the more the piston has moved and the higher the delivered dosage. In 1760, an indication of the delivered dosage is provided. For example, a correct injection, where the full dose was delivered correctly, may be indicated by a green light or a number (representing the amount of substance delivered in microliters). On an incorrect injection, the amount of substance actually delivered is displayed. In 1765, reuse of the nose segment is prevented, for example, by the blown fuse in the nose segment.

Figure 18 is a flow chart of a method of injecting a substance into an eye according to the principles of the present invention. Figure 18 illustrates a method of activating the temperature control device to heat or cool the substance located in the dispensing chamber while the nose segment and limited reuse assembly are located in a charging station. In 1805, a connection between a high end segment and a limited reuse set is recognized. In 1810, the tip segment type is identified. In 1815, tip segment dosing information is received. In 1820, it is determined whether or not the nose segment and the limited reuse assembly are located on the charging base. If they are not located on the loading cradle, then in 1825, the system waits and returns to 1820. If the nose segment and limited reuse set are located on the charging cradle, then by 1830 the Temperature control device is activated to change a temperature of the substance contained in the dispensing chamber. In 1835, temperature information is received from a thermal sensor. In 1840, this temperature information is used to control the temperature control device.

Figure 19 is a flow chart of a method for injecting a substance into an eye according to the principles of the present invention. Figure 19 illustrates a method of determining whether or not the appropriate dosage has been delivered. In 1910, the actuator is controlled based on a dosage and dosage rate information. The actuator moves the plunger to deliver the substance. In 1920, information is received from the displacement sensor indicating the distance by which the actuating axis has moved. In 1930, this distance information is used to determine if an appropriate dosage has been delivered. If the actuator shaft has moved the distance required to deliver the proper dosage, then in 1940 an indication is given that the proper dosage has been delivered. If the actuator shaft has not moved the distance required to deliver the proper dosage, then in 1950, the delivered dosage is calculated based on the distance the shaft has moved. In 1960, an indication of the delivered dosage is provided.

Figure 20 is a flow chart of a method for injecting a substance into an eye according to the principles of the present invention. Figure 20 refers to the situation where the actuator shaft has come to a standstill. In 2010, the actuator is controlled based on a dosage and dosage rate information. The actuator moves the plunger to deliver the substance. By 2020, data is received from a standstill sensor. By 2030, this data is used to determine if the actuator shaft has stopped. If the axis has stopped, then in 2040, an indication of the stopping condition is given. By 2050, data is received from a displacement sensor indicating the distance the actuator shaft has moved. For 2060, an indication of the dosage delivered based on the distance information is provided. If the shaft has not stopped, then by 2070 an indication is given that the proper dosage has been delivered.

From the foregoing, it can be appreciated that the present invention provides an improved system and methods for delivering accurate volumes of a substance to an eye. The present invention provides a single use disposable delivery tip segment that is capable of delivering accurate dosing. The nib segment interfaces with a limited reuse set. The present invention is illustrated herein, for example, and various modifications may be made by one of ordinary skill in the art.

Although the present invention is described in the context of a single use drug delivery device, the present invention encompasses any single use medical device that interfaces with an electrical power source. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the report and practice of the invention described herein. It is intended that the report and the examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (12)

A disposable injection device (205) comprising: a dispensing chamber housing (405) having an inner surface and an outer surface, the inner surface partially defining a dispensing chamber for holding a quantity of a substance; a plunger (415) engaged with the inner surface of the dispensing chamber housing, the plunger being able to slide into the dispensing chamber housing, the plunger being fluidly sealed to the inner surface of the dispensing chamber housing, the piston a plunger interface (420); a needle (210) fluidly coupled to the dispensing chamber; and a temperature control device (450) at least partially surrounding the dispensing chamber housing, the temperature control device for changing the temperature of the substance in the dispensing chamber; where the substance is injected after the temperature of the substance is changed. Disposable injection device according to claim 1, comprising: a thermal sensor (460) located near the dispensing chamber housing, the thermal sensor for measuring a temperature. Disposable injection device according to claim 2, wherein a temperature of the substance is extrapolated from a temperature measured near the dispensing chamber housing. Disposable injection device according to claim 1, further comprising: a pair of nose interface connectors (451, 452, 453) disposed on a disposable injection device interface surface adapted to electrically couple the disposable injection device (205) to a limited reuse assembly (250). Disposable injection device according to claim 4, further comprising: a fuse (1011) electrically connected to the pair of interface connectors where, if the fuse blows, the use of the disposable injection device is prevented. . Disposable injection device according to claim 4, wherein a temperature control device (450) is electrically coupled to the pair of interface connectors (452). Disposable injection device according to claim 4, further comprising: a thermal sensor (460) electrically coupled to the interface connector pair (451). Disposable injection device according to claim 4, further comprising: an assembly (555) electrically connected to the pair of electrical connectors (453), the assembly comprising a memory device, optionally storing information about a disposable injection device characteristic, selected from dosage information and / or delivery rate information. A disposable injection device according to claim 1, further comprising: an RFID marker (1110) located near an interface surface of the disposable injection device, the RFID marker having information about a feature of the device injection molding, selected from dosage information and / or delivery rate information. A disposable injection device according to claim 1 further comprising: at least one tab (472, 473) located on an interface surface of the disposable injection device, the tab holding the disposable injection device at a limited reuse assembly and where, if there are two tabs, a first and a second tab optionally have different sizes or different shapes. Disposable injection device according to claim 1, wherein the plunger interface (420) has a shape that is designed to align the disposable injection device with a reuse assembly. The system of claim 1, wherein an initial amount of the substance is preloaded into the dispensing chamber (405) and a dosage of the substance comprising less than the initial amount is delivered by the movement of the plunger ( 415) in the dispensing chamber.