JP2010535040A - Limited reuse assembly for ophthalmic injection devices - Google Patents

Abstract

  A limited reuse assembly for an ophthalmic handpiece includes an actuator having a shaft, a power source for supplying power to the actuator, a controller for controlling the actuator, a mechanical coupling interface, and a housing. Have. The mechanical coupling interface is attached to the shaft of the actuator and has a mating surface at one end. The housing at least partially encloses the power source, the controller, and the actuator. The limited reuse assembly is detachable from a disposable injection device.

Description

No. 11 / 581,629 filed Oct. 16, 2006, U.S. Patent Application No. 11 / 581,630 filed Oct. 16, 2006, U.S. patent filed Oct. 16, 2006. No. 11 / 581,591 and US patent application Ser. No. 11 / 435,906 filed May 17, 2006.
The present invention relates to disposable medical devices, and more particularly to a two-piece ophthalmic drug delivery device with a disposable tip having an improved plunger coupling and seal.

  A number of diseases and conditions in the back of the eyeball threaten vision. For example, age-related macular degeneration (ARMD), choroidal neovascularization (CND), retinal disorders (eg diabetic retinopathy, vitreoretinopathy), retinitis (eg cytomegalovirus (CMV) retinitis), grapes This includes membrane inflammation, macular edema, glaucoma, and neuropathy.

  These and other diseases can be treated by injecting drugs into the eye. Such injections are usually done manually using conventional syringes and needles. FIG. 1 is a perspective view of a conventional syringe used to inject drugs into the eye. In FIG. 1, the syringe has a needle 105, a luer hub 110, a chamber 115, a plunger 120, a plunger shaft 125, and a thumb rest 130. As is well known, the drug to be injected is in chamber 115. Pressing the thumb rest 130 causes the plunger 120 to eject the medicine through the needle 105.

  When using such a syringe, the surgeon punctures the eyeball tissue with a needle, holds the syringe firmly, and operates the syringe plunger (with or without the assistance of a nurse) to liquid inside the eyeball. Must be injected. Since the vernier on the syringe is not exactly proportional to the small injection volume, the injection volume is usually not controlled in an accurate manner. The liquid flow rate is not controlled. Also, reading the vernier also tends to suffer parallax. It can also damage tissue due to “unstable” injections. There is also a possibility that the medicine flows backward when the needle is pulled out of the eyeball.

  Previous attempts have been made to control the delivery of small amounts of liquid. Commercially available liquid dispensers include the ULTRA® positive displacement dispenser from EFD, Providence, Rhode Island. This ULTRA dispenser is typically used for dispensing small amounts of industrial adhesives. It utilizes a conventional syringe and a customized dispensing tip. The syringe plunger is actuated using an electric step motor and working fluid. Parker Hann-ifin, Cleveland, Ohio, distributes small-volume liquid dispensers for drug discovery made by Aurora Instruments-Lens LLC, San Diego, California. Parker / Aurora dispensers use a piezoelectric dispensing mechanism. Switzerland's Ypsmed produces a family of injection pens and automated syringes, mainly for the patient's own insulin and hormone injections. The product line includes a simple disposable pen and an electronically controlled electric syringe.

  In Patent Document 1, in fluid / fluid exchange during a surgical operation for dealing with retinal detachment or retinal tear, a viscous fluid (for example, silicone oil) is injected into the eyeball, while a second viscous fluid (for example, a silicone fluid) is injected into the eyeball (for example, An ophthalmic system for aspirating a perfluorocarbon liquid) is disclosed. The system includes a conventional syringe with a plunger. One end of the syringe is fluidly connected to a pressure source that supplies a constant air pressure to actuate the plunger. To administer the viscous fluid to be injected, the other end of the syringe is fluidly coupled to the infusion cannula via tubing.

US Pat. No. 6,290,690

  It would be desirable to have a portable handpiece for injecting medication into the eyeball with a relatively inexpensive tip segment that is detachable from a reusable assembly. Placing more expensive components such as electronic components and drive mechanisms in reusable assemblies while retaining sterile components in the tip assembly improves the efficiency and cost performance of the drug delivery system It will be. It would also be desirable to have a reusable assembly with functional parts for the injection process. It is also preferable to have a disposable tip segment that can then be easily attached to a reusable assembly during injection and can be easily removed and discarded after injection. Such a system provides significant benefits over conventional syringes.

  In one embodiment consistent with the principles of the present invention, the present invention comprises a regenerative actuator comprising a shafted actuator, a power source for supplying power to the actuator, a controller for controlling the actuator, a mechanical coupling interface and a housing. Consists of limited use assembly. The mechanical coupling interface is coupled to the actuator shaft and includes a mating surface at one end. The housing at least partially surrounds the power source, the controller and the actuator. The limited reuse assembly is detachable from the disposable injection device.

  In another embodiment consistent with the principles of the present invention, the present invention provides an actuator with a shaft, a power source for supplying power to the actuator, a controller for controlling the actuator, a mechanical coupling interface, a housing and an indicator Consists of a limited reuse assembly. The mechanical coupling interface is coupled to the actuator shaft and includes a mating surface at one end. The housing at least partially surrounds the power source, the controller and the actuator. An indicator is located on the housing and provides information regarding the status of the limited reuse assembly. The controller controls the operation of the actuator so that the actuator drives the actuator shaft so that a predetermined dose of drug is dispensed into the eyeball.

  It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed. I want. Both the following description and the practice of the present invention illustrate and suggest further advantages and objects of the invention.

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

It is a perspective view of the syringe by a prior art. 1 illustrates an ophthalmic medical device including a disposable tip segment and a limited reuse assembly according to an embodiment of the present invention. FIG. FIG. 5 illustrates another embodiment of a limited reuse assembly in accordance with the principles of the present invention. 6 is a cross-sectional view illustrating another embodiment of a limited reuse assembly in accordance with the principles of the present invention. FIG. 1 is a cross-sectional view of a disposable tip segment and limited reuse assembly according to one embodiment of the invention. FIG. 1 is a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention. FIG. 1 is a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention. FIG. 2 is a cross-sectional view of a disposable tip segment and a partial view of a limited reuse assembly, according to one embodiment of the invention. FIG. 1 is a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention. FIG. FIG. 9B is an end view of the embodiment of FIG. 9A. 1 is a schematic diagram of a circuit that may be included in an embodiment of the present invention. 1 is a schematic diagram of a circuit that may be included in an embodiment of the present invention. 1 is a schematic diagram of a circuit that may be included in an embodiment of the present invention. 1 is a schematic diagram of a circuit that may be included in an embodiment of the present invention. 1 is an end view of a limited reuse assembly in accordance with the principles of the present invention. FIG. 1 is a cross-sectional view of a limited reuse assembly according to one embodiment of the invention. FIG. 1 is a cross-sectional view of a limited reuse assembly according to one embodiment of the invention. FIG. 1 is a cross-sectional view of a subassembly in accordance with the principles of the present invention. 1 is a cross-sectional view of a subassembly in accordance with the principles of the present invention. 1 is a cross-sectional view of a limited reuse assembly, a tip segment and a filling base in accordance with the principles of the present invention. 3 is a flow chart of one method related to intraocular substance injection in accordance with the principles of the present invention. 3 is a flow chart of one method related to intraocular substance injection in accordance with the principles of the present invention. 3 is a flow chart of one method related to intraocular substance injection in accordance with the principles of the present invention. 3 is a flow chart of one method related to intraocular substance injection in accordance with the principles of the present invention. 3 is a flow chart of one method related to intraocular substance injection in accordance with the principles of the present invention.

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

  FIG. 2 is one drawing of an ophthalmic medical device including a disposable tip segment and a limited reuse assembly, according to one embodiment of the present invention. In FIG. 2, the medical device includes a tip segment 205 and a limited reuse assembly 250. The tip segment 205 includes a needle 210, a housing 215 and an option light 275. The limited reuse assembly 250 includes a housing 255, a switch 270, a lock mechanism 265, and a screw portion 260.

  The tip segment 205 is detachable from the limited reuse assembly 250. In this embodiment, the tip segment 205 comprises a threaded portion that is threaded onto the threaded portion 260 of the limited reuse assembly 250 on the inner surface of the housing 215. Further, the locking segment 265 secures the tip segment 215 to the limited reuse assembly 250. The locking mechanism 265 may be in the form of a button, slide switch, or cantilever mechanism. Other mechanisms for connecting the tip segment 205 to the limited reuse assembly 250, such as having structural features that align with each other, are known in the art and are within the scope of the present invention.

  The needle 210 is configured to administer a substance such as a drug into the eyeball. Needle 210 may have any known shape. Desirably, needle 210 is designed such that its thermal properties result in specific drug delivery. For example, when administering a heated medicament, the needle 210 may be relatively short (a few millimeters) in length to facilitate proper delivery of the medicament (for thermal purposes).

  Switch 270 is adapted to provide input to the system. For example, the switch 270 may be used to start a system or turn on a temperature control device. Other switches, buttons or user-initiated control inputs are generally known and may be mounted on the limited reuse assembly 250 and / or the tip segment 205.

  When the tip segment 205 is ready for use, the option light 275 is lit. The option light 275 may protrude from the housing 215, or may be stored in the housing 215. However, in this case, the option light 215 is viewed through the transparent portion of the housing 215. In other embodiments, the option light 275 may be replaced with an indicator such as a liquid crystal display, a split display, or other device that indicates the state of the disposable tip segment 205. For example, the option light 275 blinks to indicate other conditions such as, but not limited to, a system error, battery charge status, insufficient battery charge status, or poor connection between the tip segment 205 and the limited reuse assembly 250. May be. Although an indicator is shown here at the tip segment 205, an optional light 275 and additional indicators may be placed on the limited reuse assembly 250.

  FIG. 3 is another embodiment of a limited reuse assembly according to the principles of the present invention. The limited reuse assembly 250 includes a button 308, a display 320 and a housing 330. The disposable tip segment 205 is coupled to the end 340 of the limited reuse assembly 250. Button 308 is actuated to provide input to the system. Similarly to the switch 270, the temperature control device may be operated by the button 308, or the operation of the plunger may be started. Display 320 may comprise a liquid crystal display, a split display, or other device that indicates the status of disposable tip segment 205 or limited reuse assembly 250.

  FIG. 4 is a cross section of another embodiment of a limited reuse assembly according to the principles of the present invention. In FIG. 4, the power source 505, the interface 517, the actuator 515, and the actuator shaft 510 are disposed in the housing 255. An upper portion of the housing 255 is a screw portion 260. Lock mechanism 265, switch 270, button 308 and indicators 306, 307 are all disposed on housing 255.

  Normally, the power source 505 is composed of a rechargeable battery such as a lithium ion battery, but may be other types of batteries. Further, any other type of power battery can be used as the power source 505. A power source 505 powers the system, particularly the actuator 515. The power source 505 also powers the tip segment connected to the limited reuse assembly 250. In such a case, the power source 505 may supply power to a temperature control device (not shown) located in the tip segment. Optionally, the power source 505 can be removed from the housing 255 via a door or other similar mechanism (not shown).

  In general, the interface 517 is made of a conductor capable of supplying power from the power source 505 to the actuator 515. Other interfaces, such as interface 517, may be provided to provide power to other parts of the system.

  The actuator shaft 510 is driven by being connected to the actuator 515. The actuator 515 is typically a step motor or other type of motor that can move the actuator shaft 510 with a precise distance. In one embodiment, the actuator shaft 510 is connected via a mechanical link to a tip segment that delivers drug to the eyeball. In such a case, the actuator 515 is composed of a step motor that can move the shaft 510 accurately to deliver the correct amount of drug to the eyeball. The actuator 515 is fixed to the inner surface of the housing 255 by a tab that engages with the outer surface of the actuator, for example.

  In other embodiments, actuator 515 is a linear actuator or a linear driver. In such a case, the actuator 515 is a spring or a spring drive mechanism, a gear DC motor with a rotation sensor attached to a linear drive, a DC motor attached to a linear drive with a linear sensor, or a linear step motor. Good. Also, other types of motors such as a rotary permanent magnet motor may be used for the actuator 515.

  The locking mechanism 265, the switch 270, and the button 308 are all disposed on the housing 255 so that they can be operated by hand. Similarly, indicators 306, 307 are also disposed on housing 255 so that they can be seen. Further, the lock mechanism 265, the switch 270, the button 308, and the indicators 306 and 307 are all connected to a controller (not shown) through an interface (not shown) located in the housing 255.

  FIG. 5 is a cross-sectional view of a disposable tip segment and limited reuse assembly according to one embodiment of the present invention. FIG. 5 shows how the tip segment 205 connects to the limited reuse assembly 250. In the embodiment shown in FIG. 5, the tip segment 205 comprises an assembly 555, a plunger interface 420, a plunger 415, a dispensing chamber housing 425, a tip segment housing 215, a temperature controller 450, a thermal sensor 460, a needle 210, a dispensing chamber 405. , Interface 530 and tip interface connector 453. The limited reuse assembly 250 includes a mechanical coupling interface 545, an actuator shaft 510, an actuator 515, a power supply 505, a controller 305, a limited reuse assembly housing 255, an interface 535, and a limited reuse assembly interface connector 553.

  In the tip segment 205, the plunger interface 420 is disposed at one end of the plunger 415. The other end of the plunger 415 forms one end of the dispensing chamber 405. Plunger 415 is adapted to slide within dispensing chamber 405. The outer surface of the plunger 415 is fluid sealed to the inner surface of the dispensing chamber housing 425. Dispensing chamber housing 425 surrounds dispensing housing 405. Typically, the dispensing chamber housing 425 is cylindrical. Similarly, the dispensing chamber 405 is also cylindrical. In the tip segment 205, the assembly 555 comprises a number of parts described below.

  Needle 210 is fluidly connected to dispensing chamber 405. In such a case, the substance contained in the dispensing chamber 405 can enter the eyeball through the needle 210. The temperature controller 450 at least partially surrounds the dispensing chamber housing 425. In this case, the temperature controller 450 is adapted to heat and / or cool the material in the dispensing chamber housing 425 and the dispensing chamber 405. The interface 530 connects the temperature controller 450 to the tip interface connector 453.

  Dispensing chamber housing 425, temperature controller 450 and plunger 415, each component of tip segment 205 is at least partially enclosed by tip segment housing 215. In one embodiment consistent with the principles of the present invention, the plunger 415 is sealed against the inner surface of the dispensing chamber housing 425. This seal can prevent contamination from any material contained in the dispensing chamber 405. Such seals are preferred for medical purposes. This seal can be located at any point on the plunger 415 or the dispensing chamber housing 425.

  In the limited reuse assembly 250, the power source 505 powers the actuator 515. An interface (not shown) between the power supply 505 and the actuator 515 serves as a conduit for supplying power to the actuator 515. The actuator 515 is connected to the actuator shaft 510. When the actuator 515 is a step motor, the actuator shaft 510 is integrated with the actuator 515. A mechanical coupling interface 545 is connected to the actuator shaft 510. Also in this configuration, when the actuator 515 moves the actuator shaft 510 upward toward the needle 210, the mechanical coupling interface 545 also moves upward toward the needle 210. In other embodiments of the present invention, the mechanical coupling interface 545 and the actuator shaft 510 are comprised of a single piece. In other words, the shaft connected to the actuator 515 will comprise both the actuator shaft 510 and the mechanical coupling interface 545 as a single assembly.

  Controller 305 is connected to limited reuse assembly interface connector 553 via interface 535. Limited reuse assembly interface connector 553 is disposed on the upper surface of limited reuse assembly housing 255 adjacent to mechanical coupling interface 545. Thus, both the limited reuse assembly interface connector 553 and the mechanical coupling interface 545 are configured to connect to the tip interface connector 453 and the plunger interface 420, respectively.

  The controller 305 and the actuator 515 are connected by an interface (not shown). This interface (not shown) enables operation control of the controller 305 to the actuator 515. In addition, an interface (not shown) between the power supply 505 and the controller 305 enables operation control of the controller 305 to the power supply 505. In such a case, when the power source 505 is a rechargeable battery, the controller 305 may control charging and discharging of the power source 505.

  The controller 305 typically consists of an integrated circuit with power supply, input and output pins that can perform logic functions. In various embodiments, the controller 305 is a targeted device controller. In such a case, the controller 305 executes a specific control function for a specific device or component such as a temperature control device or a power supply device. For example, the temperature control device controller has a basic function for controlling the temperature control device. In other embodiments, the controller 305 comprises a microprocessor. In such cases, the controller 305 can be programmed to control one or more components that make up the device. In other cases, the controller 305 may not be a programmable microprocessor, in which case it will be a special purpose controller configured to control different components that perform different functions. In FIG. 5, the controller 305 is shown as one component, but it may be constituted by many different components and integrated circuits.

  The tip segment 205 is adapted to be coupled to or attached to the limited reuse assembly 250. In the embodiment of FIG. 5, the plunger interface 420 located on the bottom surface of the plunger 415 is configured to couple with a mechanical coupling interface 545 located near the top surface of the limited reuse assembly housing 255. In addition, the tip interface connector 453 is adapted to connect with a limited reuse assembly interface connector 553. Thus, when the tip segment 205 is connected to the limited reuse assembly 250, the actuator 515 and the actuator shaft 510 drive the plunger 415 upward toward the needle 210. Further, an interface is formed between the controller 305 and the temperature control device 450. Signals can be sent from the controller 305 through the interface 535, limited reuse assembly interface connector 553, tip interface connector 453, and interface 530 to the temperature controller 450.

  In operation, the controller 305 controls the operation of the actuator 515 when the tip segment 205 is connected to the limited reuse assembly 250. When the actuator 515 is operated, the actuator shaft 510 is moved upward toward the needle 210. This causes the mechanical coupling interface 545 coupled to the plunger interface 420 to move the plunger 415 upward toward the needle 210. The substance in dispensing chamber 405 is then ejected through needle 210.

  Further, the controller 305 controls the operation of the temperature control device 450. The temperature controller 450 is adapted to heat and / or cool the dispensing chamber housing 425 and its contents. Dispensing chamber housing 425 is at least partially heat conducting, so heating or cooling dispensing chamber housing 425 heats or cools the material in dispensing chamber 405. Temperature information from the thermal sensor 460 can be communicated to the controller 305 via the interface 530, the tip interface connector 453, the limited reuse assembly interface connector 553 and the interface 535. This temperature information can be used to control the operation of the temperature controller 450. When the temperature control device 450 is a heater, the controller 305 controls the current value to the temperature control device 450. The greater the current sent to the temperature controller 450, the hotter the device. In such a manner, the controller 305 can utilize a feedback loop using information from the thermal sensor 460 to control the operation of the temperature controller 450. For example, any type of control algorithm, such as a proportional / integral / derivative (PID) algorithm, can be used to control the operation of the temperature controller 450.

  FIG. 6 is a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention. In FIG. 6, the disposable tip segment 205 includes a housing 215, a needle 210, a plunger 415, a plunger interface 420, a dispensing chamber 405, a dispensing chamber housing 425, an assembly 555, a temperature controller 450, a thermal sensor 460, an optional lure. 430, tip interface connectors 451, 452, and 453 and interfaces 461, 462, 463. The disposable tip segment 205 functions as a disposable injection device.

  In the embodiment of FIG. 6, the plunger 415 is located within the dispensing chamber housing 425. Dispensing chamber 405 is closed by dispensing chamber housing 425 and plunger 415. Plunger 415 forms a fluid seal with the inner surface of dispensing chamber housing 425. Needle 210 is fluidly connected to dispensing chamber 405. In this manner, the substance in the dispensing chamber 405 is pushed out of the needle 210 in contact with the plunger 415. Needle 210 may be secured to disposable tip segment 205 by an optional luer 430 or may be permanently attached. The temperature controller 450 is disposed on the dispensing chamber housing 425 and at least partially surrounds the dispensing chamber 405. Housing 215 forms the outer skin of disposable tip segment 205.

  In various embodiments of the present invention, the temperature controller 450 comprises a heating and / or cooling device. The temperature controller 450 is in thermal contact with the dispensing chamber housing 425. As a result, the temperature controller 450 can change the temperature of the substance in the dispensing chamber 405.

  In FIG. 6, the plunger 415 includes an O-ring. The O-ring seals to the inner surface of the dispensing chamber housing 425. In this way, a sterilization seal is retained to avoid contamination of the substance in the dispensing chamber 405. The plunger 415 may be formed of any compatible material, such as glass, stainless steel, or a polymer compound. The O-ring is usually formed from rubber or a polymer compound. Other types of seals may be used. For example, the plunger 415 may include an annular ring, and the annular ring may contact the inner surface of the dispensing chamber 425 by being arranged around the outer periphery of the plunger 415. This annular ring can seal the plunger against the inner surface of the dispensing chamber 425. In such a case, the annular ring may be integrated with the plunger 415, and the plunger 415 may be formed from rubber or a polymer compound. Plunger interface 420 may have any shape. For example, the plunger interface may be substantially bowl-shaped as shown, substantially flat, conical or spherical. The plunger interface may also be provided with a lip or other similar mechanism.

  Tip interface connectors 451, 452, 453 contribute to the connection between tip segment 205 and the limited reuse assembly. The interface 461 connects the heat sensor 460 to the tip interface connector 451. Interface 462 connects temperature controller 450 to tip interface connector 452. Interface 463 connects assembly 555 to tip interface connector 453.

  The assembly 555 can comprise any of many different parts. In one embodiment, the assembly 555 comprises a fuse that is blown when the thermal button is activated or after use of the disposable tip segment 205. This method prevents reuse of the disposable tip segment 205 by the fuse. In another embodiment, the assembly 555 may include information regarding the type of disposable tip segment 205, dosage information, temperature information, plunger motion information, or other information identifying the properties of the disposable tip segment 205, or the disposable tip segment 205. A memory for storing the operating method of the segment 205 is provided. In other embodiments, the assembly 205 is a wired storage device such as a NAND flash IC, RFID tag, a hard wired wired circuit capable of storing something representing data, such as a series of fuses and resistors connected in parallel. Or other types of devices.

  A substance, usually a drug, to be administered to the eyeball is located in the dispensing chamber 405. In this method, the drug contacts the inner surface of the dispensing chamber housing 425 and one surface of the plunger 415. The temperature controller 450 is in thermal contact with the dispensing chamber housing 425. In this way, the temperature controller 450 controls the contents temperature of the dispensing chamber 405.

  In various embodiments of the present invention, the temperature controller 450 heats the phase change compound located in the dispensing chamber 405. This phase change compound carries the drug to be injected into the eyeball. The phase change compound may be solid, or a semi-solid state at low temperatures and a more liquid state at high temperatures. Such a substance can be heated to a more liquid state with the temperature controller 450 and injected into the eye, where it can form a rapid intravenous solution that will wear away over time. Similarly, a reverse gelling compound may be used. The reverse gelling compound may be a solid or a semi-solid state at low temperatures and a more liquid state at high temperatures. Such compounds can form a rapid intravenous solution that is cooled to a more liquid state by the temperature controller 450 and injected into the eye where it wears out over time. As such, the temperature control device 450 may be a device that heats the material in the dispensing chamber 405 or a device that cools the material in the dispensing chamber 405 (or a combination of both). After intraocular administration, the phase transition compound and the reverse gelling compound wear away over time, and a certain amount of drug will be supplied over a long period of time. By using a phase transition compound or a reverse gelling compound, better drug administration can be achieved with fewer injections.

  The thermal sensor 460 provides temperature information useful for controlling the operation of the temperature controller 450. A thermal sensor 460 may be placed near the dispensing chamber housing 425 to measure the temperature near the dispensing chamber housing 425. Alternatively, the thermal sensor 460 may be placed in thermal contact with the dispensing chamber housing 425 so that the temperature of the dispensing chamber housing 425 is measured. In other embodiments, the temperature measured by the thermal sensor 460 can be correlated to the material temperature in the dispensing chamber 405. In other words, the temperature measurement of the dispensing chamber housing 425 can be used to calculate the material temperature in the dispensing chamber 405. Since the thermal characteristics of the dispensing chamber housing 425 and the materials therein are known and the temperature of the temperature controller 450 is controllable, the result of using the temperature controller over a specified period of time is the result. As a result of a calculable change in the substance temperature in the dispensing chamber 405. The thermal sensor 460 may be any of a number of different devices that can provide temperature information. For example, the thermal sensor 460 may be a thermocouple or a resistance device whose resistance value changes with temperature.

  In one embodiment of the present invention, the substance in the dispensing chamber 405 comprises a drug that has been pre-filled into the dispensing chamber. In such a case, the disposable tip segment 205 is suitable as a disposable consumable. Such disposable products can be assembled at the factory with a predetermined amount of drug installed.

  When the dispensing chamber 405 is prefilled with a medicine, a preset amount of the medicine can be prefilled. For example, 100 microliters of drug can be filled into the dispensing chamber 405 and any amount of drug up to 100 microliters can be administered. Information regarding the amount of drug present in dispensing chamber 205 and other dosage information may be stored in assembly 555. In such a case, the plunger 415 can be moved a precise distance from the dispensing chamber 405 via the needle 210 to dispense the correct amount of drug into the eyeball. This provides dosage flexibility and ease of assembly.

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

  The embodiment of FIG. 7 functions as the embodiment of FIG. The various components that make up the tip segment 205 of FIG. 7 have the same characteristics as the components of FIG. 6 and operate in substantially the same manner. Locking mechanism 471 serves to attach tip segment 205 to the limited reuse assembly. A coupling mechanism, such as a locking mechanism 265 on the limited reuse assembly, couples to the locking mechanism 471 and secures the tip segment 205 to the limited reuse assembly.

  FIG. 8 is a cross-sectional view of a disposable tip segment and a partial view of a limited reuse assembly according to an embodiment of the present invention. In FIG. 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 controller 450, tip interface connector 452, and An interface 462 is included. A partial view of the limited reuse assembly shows mechanical coupling interface 545, actuator shaft 510, interface 535, limited reuse assembly interface connector 552, RFID reader 1120 and RFID interface 1130.

  The embodiment of FIG. 8 functions like the embodiment of FIGS. The various components that make up the tip segment 205 of FIG. 8 have the same characteristics as the components of FIGS. 6 and 7 and operate in substantially the same manner. However, the embodiment of FIG. 8 uses an RFID system rather than a wired assembly 555 for storing and transmitting information. The RFID reader 1120 is positioned adjacent to the mechanical coupling interface 545 near the tip of the adjacent reuse limit assembly. The RFID tag is located at the bottom of the tip segment 205. The RFID reader 1120 is designed to read information from the RFID tag 1110. The RFID interface 1130 is connected to the controller 305 (not shown).

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

  In a passive RFID system, which is one type of RFID system, the RFID tag 1110 does not have a power supply device. Instead, passive RFID tags rely on the electromagnetic field generated by RFID reader 1120 for their power. The electromagnetic field generated by the RFID reader 1120 and emitted from the RFID reader antenna (not shown) induces a small current in the RFID tag 1110. The RFID tag 1110 is activated by this small current. In this passive system, the RFID tag is designed to collect power from the electromagnetic field emitted by the RFID reader 1120 and further transmit an outbound signal received by the RFID reader 1120.

  In operation, an RFID reader antenna (not shown) transmits a signal generated by the RFID reader 1120. An RFID tag antenna (not shown) receives this signal and a small current is induced in the RFID tag 1110. This small current supplies power to the RFID tag 1110. The RFID tag 1110 can transmit a signal to the RFID reader antenna and the RFID reader 1120 itself via the RFID tag antenna. In this way, the RFID tag 1110 and the RFID reader 1120 can communicate with each other over the radio frequency link. The RFID tag 1110 transmits information such as dosage information and tip segment information to the RFID reader 1120 via the RFID tag antenna. This information is received by the RFID reader 1120. In this way, information can be communicated from the tip segment 205 to the limited reuse assembly. RFID reader 1120 can similarly communicate information to RFID tag 1110. For example, the RFID reader 1120 can convey information such as dosage information on a radio frequency signal emitted by the RFID reader 1120. The RFID tag 1120 receives this radio frequency signal with information. At this time, the RFID tag 1110 can store this information.

  Although the embodiment of FIG. 8 has been described as having an RFID system, any type of wireless system can be used for information transfer between the limited reuse assembly 250 and the tip segment 205. For example, perhaps the Bluetooth protocol would have established a communication link between the limited reuse assembly 250 and the tip segment 205. Information can then be communicated between the limited reuse assembly 250 and the tip segment 205 over this communication link. Other embodiments used for information transmission include infrared protocols, 802.11, firewire or other wireless protocols.

  In one embodiment, RFID tag 1110 (or assembly 555) includes dosage information. Information regarding the appropriate dosage for the drug contained in dispensing chamber 405 may be included on RFID tag 1110 (or assembly 555). In such a case, the controller 305 can read dosage information from the RFID tag 1110 (or assembly 555) and actuate the actuator 515 in a suitable manner to achieve proper dosing. For example, the dispensing chamber 405 may contain 100 microliters. In this case, information that a 20 microliter dose should be made inside the eyeball may be stored on the RFID tag 1110 (or assembly 555). In such a case, the controller 305 will read the dosage information (ie, information that 20 microliters of medication should be administered to the eyeball) from the RFID tag 1110 (or assembly 555). At this time, the controller 305 can actuate the actuator 515 to dispense 20 microliters. Controller 305 allows actuator 515 to move actuator shaft 510 and mechanical coupling interface 545 by a set distance related to 20 microliters of dosing. In such a case, the plunger 415 is moved by this predetermined distance so that only 20 microliters of medicine is ejected from the needle 210 and enters the eyeball.

  In another embodiment consistent with the principles of the present invention, the controller 305 may calculate the travel distance required for the plunger 415 to achieve the desired dosage. For example, if dosage information corresponding to 20 microliters of drug administration is read from the RFID tag 1110 (or assembly 555) by the controller 305, the controller 305 will then determine the appropriate travel distance required for the plunger 415. This information may be used to calculate. Since the volume of the dispensing chamber 405 itself is known, as well as the volume of the drug filled in the dispensing chamber 405, the travel distance of the plunger 415 required to achieve the required amount of dispensing should be calculated by the controller 305. Can do. When the dispensing chamber 405 is cylindrical, the volume of the dispensing chamber can be calculated by the cylindrical cross-sectional area (circle area) x the dispensing chamber height. This simple formula can also be used to calculate the total volume of the dispensing chamber 405. Since the cross-sectional area of the dispensing chamber 405 is constant for any given application, the height corresponding to the plunger 415 travel distance can be calculated for any dosage.

  For example, assume that 100 microliters of medicine has been filled into dispensing chamber 405 and that the dispensing chamber 405 has a cross-sectional area of 10. When the dispensing chamber 405 is cylindrical, the height of the cylinder is also 10. In order to dispense 20 microliters, corresponding to 20% of the total volume of dispensing chamber 405, it is necessary to move plunger 415 upwardly toward needle 210 by a distance of two. In other words, a 20 microliter dose corresponds to 20% of the total volume of the dispensing chamber 405. In such a case, plunger 415 must move upward toward needle 210 by a distance equal to 20% of the total height of dispensing chamber 405. At that time, the controller 305 can control the actuator 515 such that the actuator shaft 510 drives the plunger 415 upward by a distance of 20% of the total height of the dispensing chamber 405.

  In addition, the controller 305 may read information on the speed at which the plunger 415 should be moved to deliver a predetermined amount of the appropriate drug. In such a case, the controller 305 reads information about the medication rate from the RFID tag 1110 (or assembly 555) and uses that information to actuate the actuator 515 to move the plunger 415 at that rate. The moving speed of the plunger 415 may be a fixed value or variable. In some applications, it may be preferable to move the plunger 415 faster than other applications. For example, if the drug contained in the dispensing chamber 405 is to be heated before being injected into the eyeball, the plunger 415 is moved at a rate such that the heated drug does not cool and clog the needle 210. It may be preferable to move. In other applications, it may be desirable to move the plunger 415 slowly to improve drug administration contained in the dispensing chamber 405.

  Also, RFID tag 1110 (or assembly 555) may also include any other information regarding drug administration. For example, the RFID tag 1110 (or assembly 555) may provide information on the type of drug contained in the dispensing chamber 405, various characteristics of the drug, or other characteristics related to the proper dosage and proper supply of the drug. May be included. Further, the RFID tag 1110 (or assembly 555) may include safety information, proper activation information for the tip segment 205, or any other information associated with the tip segment or limited reuse assembly.

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

  It may be desirable to place dosage information on the RFID tag 1110 (or assembly 555) to reduce the likelihood of medication errors. In such cases, many different drug delivery tip segments 205 may be manufactured and filled with drug at the factory. Dosage information can also be placed on the RFID tag 1110 (or assembly 555) at the factory. In such a case, a number of different tip segments are manufactured and produced, each with the same amount of drug contained in the dispensing chamber 405, but with different dosage information stored on the RFID tag 1110 (or assembly 555). Can be shipped. The physician can also order the tip segment 205 that contains the required dosage information on the RFID tag 1110 (or assembly 555). The package can be clearly labeled so that dosage information can be identified so that the appropriate formulation is administered to the patient.

  FIG. 9A is a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention. In FIG. 9, the disposable tip segment 205 includes a housing 215, a needle 210, a plunger 415, a plunger shaft 417, a plunger interface 420, a dispensing chamber 405, a dispensing chamber housing 425, an assembly 555, a temperature controller 450, a thermal sensor 460. , Optional luer 430, tip interface connectors 452, 453, interfaces 462, 463, and tabs 472, 473.

  The various parts making up the tip segment 205 of FIG. 9 have the same characteristics as the parts of FIGS. 5-8 and operate in substantially the same manner. The embodiment of FIG. 9 includes two tabs 472, 473 that engage slots in the limited reuse assembly. After these two tabs 472, 473 are inserted into the slots, the tip assembly 205 is rotated to lock into place on the limited reuse assembly. The two tabs 472, 473 may be of different shapes and sizes to provide a suitable interface between the tip segment 205 and the limited reuse assembly. If these two tabs 472, 473 are formed differently or of different sizes, the tip segment 405 has only one orientation to fit the limited reuse assembly. In other embodiments of the invention, different shaped and sized tabs can be used with different shaped and sized slots on different limited reuse assemblies. Thus, a number of different reuse limiting assemblies may be manufactured with slots of different shapes and sizes to accommodate tip segments 205 having complementary shapes or sizes of tabs.

  Further, the embodiment of FIG. 9 includes a plunger shaft 417 connected to the plunger 415. In this embodiment, the plunger 415 may be overmolded on the plunger shaft 417. The plunger shaft 417 is formed in a substantially cylindrical shape whose intermediate diameter is smaller than the diameter of the distal end or the proximal end. The plunger interface 420 is composed of a surface on the proximal end of the plunger shaft 417. The plunger shaft 417 is typically made from a rigid material such as stainless steel. Meanwhile, the plunger 415 is made of rubber or a polymer material. In another embodiment of the invention, the distal end of the plunger shaft 417 is provided with a lip to which the plunger 415 can be applied. Plunger 415 can be press fit onto plunger shaft 417 and will be held in place by a lip at the distal end of plunger shaft 417. This allows for easier assembly. Instead of overmolding the plunger 415 on the shaft, the plunger 415 can be manufactured as a separate piece and crimped to the distal end of the plunger shaft 417. The plunger interface 420 may be any suitable shape.

  FIG. 9B is an end view of the tip segment shown in FIG. 9A. FIG. 9B shows the end of the tip segment 205 furthest from the needle 210. This end joins with the limited reuse assembly. Shown are housing 215, plunger interface 420, tip interface connectors 451, 452, 453, 454, 455, 456, tabs 472, 473 and alignment slot 481.

  In the embodiment of FIG. 9B, one end of the plunger interface 420 is not completely circular. It comprises a flat part designed to fit a mechanical coupling interface with a similar cross-sectional shape. This optional feature is designed to properly align the tip segment and the limited reuse assembly. In other embodiments of the present invention, the cross section of one end of the plunger interface 420 is circular.

  The embodiment of FIG. 9B also includes an optional alignment slot 481 that assists in properly aligning the tip segment with the limited reuse assembly. Alignment slot 481 engages an alignment pin (shown at 581 in FIG. 11) on the limited reuse assembly. In another embodiment of the invention, the tabs 472, 473 have different sizes. Alternatively, the tabs 472 and 473 may have different shapes. The two tabs 472, 473 also engage the slots 572, 573 of FIG. 11 to assist in aligning the tip segment with the limited reuse assembly.

  In one embodiment consistent with the principles of the present invention, the tip segment is positioned on the limited reuse assembly such that the tabs 472, 473 are inserted into the slots 572, 573. The tip segment is then rotated relative to the limited reuse assembly such that the tabs 472, 473 are retained in the slots 572, 573. At that time, the alignment pin 581 and the alignment slot 481 are properly aligned.

  Connectors 451, 452, 453, 454, 455, 456 electrically connect the tip segment to the limited reuse assembly. Connectors 451, 452, 453, 454, 455, 456 connect to similar connectors 551, 552, 553, 554, 557, 556 on the limited reuse assembly (shown in FIG. 11), respectively. These connectors provide a path for signals passing between the tip segment and the limited reuse assembly.

  10A through 10D are schematic diagrams of four different circuits that may be included in embodiments of the present invention. FIG. 10A shows one of many different configurations for the temperature controller 450. In FIG. 10A, the temperature control device 450 is connected to connectors 452 and 455. Power and / or control signals are provided to temperature controller 450 via connectors 452, 455.

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

  FIG. 10C shows one of many different configurations for the fuse 1011. The fuse 1011 may be included in the assembly 555 or implemented as shown in FIG. 10C. In FIG. 10C, the fuse 1011 is connected between the connectors 453 and 456. In this embodiment, the fuse 1011 serves to ensure that the tip segment is a disposable device. The fuse 1011 blows when the heat button is activated or after the disposable tip segment 205 is used. As described above, the controller of the limited reuse assembly detects when the connected tip segment is completely used, and further increases the current flowing through the fuse 1011 to blow the fuse 1011. When the fuse 1011 is blown, the tip segment is no longer operational and must be discarded.

  FIG. 10D shows one of many different configurations for the assembly 555. In FIG. 10D, assembly 555 is connected to connectors 453, 456. Power and / or control signals are provided to assembly 555 via connectors 453,456.

  Many other forms of connectors 451, 452 453, 454, 455, 456 may be employed. For example, although six connectors are shown in the figure, any number of connectors may be used. Furthermore, any combination of different circuits may be included in the tip segment.

  FIG. 11 is an end view of a limited reuse assembly according to the principles of the present invention. The end of the limited reuse assembly shown in FIG. 11 mates with the end of the tip segment shown in FIG. 9B. The end view of the limited reuse assembly shown in FIG. 11 includes a housing 255, a mechanical coupling interface 545, a reuse assembly interface connector 551, 552, 553, 554, 557, 556, slots 572, 573 and alignment pins 581. Show.

  In the embodiment of FIG. 11, one end of the mechanical coupling interface 545 is not completely circular. It comprises a flat portion designed to match a plunger interface with a similar cross-sectional shape. This optional feature is designed to properly align the tip segment and the limited reuse assembly. In other embodiments of the present invention, the cross section of one end of the mechanical coupling interface 545 is circular.

  The embodiment of FIG. 11 also includes an optional alignment slot 581 that assists in properly aligning the tip segment with the limited reuse assembly. The alignment pin 581 engages an alignment slot (indicated by the number 481 in FIG. 9B) on the tip segment. In another embodiment of the invention, the slots 572, 573 have different sizes. Alternatively, the slots 572 and 573 may have different shapes. The two slots 572, 573 also engage the tip segment tabs 472, 473 shown in FIG. 9B to assist in aligning the tip segment with the limited reuse assembly.

  Connectors 551, 552, 553, 554, 557, 556 electrically connect the tip segment to the limited reuse assembly. Connectors 551, 552, 553, 554, 557, 556 are coupled to connectors 451, 452 453, 454, 455, 456 (shown in FIG. 9) on the tip segment side. These connectors provide a signal path back and forth between the tip segment and the limited reuse assembly.

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

  The displacement sensor 1215 measures the movement of the actuator shaft 510. The displacement sensor may be an optical rotary encoder, linear encoder, current detection circuit (Hall sensor), rotary potentiometer or linear potentiometer, among others. In other embodiments, the displacement sensor can detect whether the actuator 515 has stalled. For example, the Hall sensor can detect an increase in current drawn by the actuator 515 indicating a stalled state. The displacement sensor 1215 may measure the counter electromotive force from the actuator 515. The displacement sensor 1215 may be a single component or a plurality of components. In one embodiment consistent with the principles of the present invention, the displacement sensor 1215 includes a device that measures the travel distance of the actuator shaft 510 and a device that detects whether the actuator 515 is stalled.

  The displacement sensor 1215 measures the position of the actuator shaft 510. Because the mechanical coupling interface 545 is connected to the actuator shaft 510, the displacement sensor 1215 measures its position. Such a displacement sensor 1215 can be used to determine whether the entire amount of drug has been administered. If the displacement sensor 1215 detects that the actuator shaft 510 has moved a specific distance corresponding to the movement of the mechanical coupling interface 545 and the plunger 415, then a predetermined amount of medicine has been ejected from the needle 210. This is an established fact. Thus, when a drug is administered to the eye, the displacement sensor 1215 provides information regarding the amount of actuator shaft 510 travel that can be used to determine whether or not the full amount of drug has been administered.

  In some cases, the actuator 515 may stall and the actuator shaft 510, the mechanical coupling interface 545, and the plunger 415 may not be driven by an appropriate distance to administer the entire amount of drug to the eyeball. In such a case, the displacement sensor 1215 measures the distance traveled by the actuator shaft 510, the mechanical coupling interface 545, and the plunger 415. From this distance information, the amount of drug actually administered can be calculated. For example, if the dispensing chamber 405 is cylindrical, its circular cross-sectional area is known. In such a case, the distance measured by the displacement sensor 1215 becomes the height of the cylinder, and the volume of the displacement can be easily calculated (for example, by the controller 305). This administered amount can be notified via a display device such as the display 320 (FIG. 3) with a stall display.

  The displacement sensor 1215 may also provide other information useful for the dosing process. For example, when the tip segment is connected to the limited reuse assembly, the actuator shaft 510 may be retracted or moved to a home position for connection with the tip segment. In this case, the displacement sensor 1215 can measure the movement of the actuator shaft 510 to this fixed position. The actuator shaft 510 may also be placed in a fixed position where the tip segment can be attached to the limited reuse assembly prior to dispensing. In one embodiment, the information read from the displacement sensor is used to confirm that the actuator shaft 510 is in place prior to actuation of the actuator 515 for dosing.

  The embodiment of FIG. 12 also includes a power supply controller 444 and an inductive element 1225. For example, if the power source 505 is a rechargeable battery, these two components will control the charging of the power source 505. The power supply controller 444 includes circuitry that can perform any of a number of different functions related to charging, monitoring and maintenance of the power supply 505. In other embodiments, the power supply controller 444 may be mounted on or integrated with the controller 305.

  In one embodiment of the present invention, the power supply controller 444 (and possibly the controller 305) counts the number of times that the limited reuse assembly 250 is used. After the counted usage count reaches a predetermined safe usage count, the limited reuse assembly 250 is disabled. Alternatively, the power supply controller 444 (or the controller 305 in some cases) counts the number of times the power supply 505 is charged (the number of charge cycles received by the power supply 505). The limited reuse assembly 250 is disabled when the counted number of charges has reached a predetermined threshold. In other embodiments of the present invention, the power supply controller 444 (and possibly the controller 305) detects a failure condition or other unsafe condition of the power supply 505 to avoid further use of the limited reuse assembly 250.

  In charging the power supply 505, current is induced in the inductive element 1225 when the inductive element 1225 is placed near another inductive element on the charging base (not shown).

  FIG. 13 is a cross-sectional view of a limited reuse assembly according to one embodiment of the present invention. In FIG. 12, limited reuse assembly 250 includes mechanical coupling interface 545, actuator shaft 510, actuator 515, power supply 505, controller 305, limited reuse assembly housing 255, interface 535, limited reuse assembly interface connector 551, A displacement sensor 1215, a power supply controller 444, and a charging contact 1235 are provided.

  In the embodiment of FIG. 13, contact 1235 joins to a contact on a charging base (not shown) to provide power to power source 505. In one embodiment, the contact 1235 comprises a USB connection, such as used in a portable electronic device with a docking station, for example. In one embodiment, a Molex® CradleC-on (Molex Cradlecon®) connector is used. Other types of connectors may be used.

  14 and 15 are cross-sectional views of two subassemblies according to the principles of the present invention. Each of these subassemblies shows a path from the actuator 515 to the needle 210. FIG. 14 shows a mechanical coupling interface 545 that is rigidly connected to the actuator shaft 510, whereas FIG. 15 shows a mechanical coupling assembly 545 with a ball joint 805. The ball joint 805 is used to help align the mechanical coupling interface 545 with the plunger interface 420.

  In FIG. 14, the actuator 515 has an actuator shaft 510 that is rigidly connected to a mechanical coupling interface 545. The mechanical coupling interface is aligned with the plunger interface 420. Plunger 415 is disposed within dispensing chamber housing 425 and is sealed to the inner surface of dispensing chamber housing 425. Dispensing chamber 405 is surrounded by the inner surface of dispensing chamber housing 425 and the distal end of plunger 415. The temperature controller 450 at least partially surrounds the dispensing chamber housing 425. Needle 210 is fluidly connected to dispensing chamber 405.

  In FIG. 15, an actuator 515 includes an actuator shaft 510 connected to a shaft 810 via a ball joint. The mechanical coupling interface 545 is rotatably connected to the shaft 810 via a ball joint 805. The mechanical coupling interface is aligned with the plunger interface 420. Plunger 415 is disposed within dispensing chamber housing 425 and is sealed to the inner surface of dispensing chamber housing 425. Dispensing chamber 405 is surrounded by the inner surface of dispensing chamber housing 425 and the distal end of plunger 415. The temperature controller 450 at least partially surrounds the dispensing chamber housing 425. Needle 210 is fluidly connected to dispensing chamber 405.

  14 and 15, the actuator 515 drives the actuator shaft 510 upward (in the direction toward the needle 210). The mechanical coupling interface 545 is then also driven upward. When the mechanical coupling interface 545 is coupled to the plunger interface 420, the plunger 420 is also driven upward. The substance contained in the dispensing chamber 405 is ejected through the needle 210. In this manner, movement and force are transmitted from the actuator shaft 510 to the mechanical coupling interface 545 and the plunger 415.

  When the dispensing chamber 405 contains a drug to be administered to the eye, the configuration of FIGS. 14 and 15 eliminates the backflow that occurs when the needle is withdrawn from the eye. The operation of the plunger 415 is a single direction (the direction in which the medicine in the dispensing chamber 405 is discharged). When the mechanical coupling interface 545 is moved away from the needle 210, for example after the drug has been injected into the eyeball, the plunger 415 remains in place. Since the plunger 415 is not firmly connected to the mechanical coupling interface 545, the plunger 415 is not retracted when the mechanical coupling interface 545 is retracted.

  16 is a cross-sectional view of the limited reuse assembly and charging base of FIG. In FIG. 16, the bottom surface of the limited reuse assembly 250 is compatible with the charging base 1615. When the limited reuse assembly 250 is placed in the charging base 1615, the power source 505 can be charged. The limited reuse assembly 250 can be removed from the charging base 1615 after charging. In one embodiment of the invention, the limited reuse assembly 250 is placed on the charging base 1615 with the tip segment 205 attached, and the material in the dispensing chamber 405 is heated and cooled by the temperature controller 450. In this way, the charging base 1615 supplies power to the temperature controller 450. When the material in dispensing chamber 405 reaches the appropriate temperature (as determined from information from thermal sensor 460), limited reuse assembly 250 with tip segment 205 attached can be removed from the charging base. . This saves the power supply 505 for the injection process when the limited reuse assembly 250 and the attached tip segment 205 are removed from the charging base 1615.

  17A and 17B are flowcharts of one method of injecting a substance into the eye according to the principles of the present invention. First at 1705, the connection between the tip segment and the limited reuse assembly is verified. Next, at 1710, the type of tip segment connected to the limited reuse assembly is identified. Here, for example, the medication tip segment itself or the type of medication tip segment may be identified. For example, the information may be identified by reading information from the tip segment such as information from a memory or an RFID tag. Next, at 1715, dosage information is received from the tip segment. Similar to tip segment type related information, dosage information may be read from a storage device in the tip segment using a controller, RFID reader, or similar device in a limited reuse assembly.

  At 1720, a temperature controller is activated to change the temperature of the material in the dispensing chamber. As described above, the material is heated or cooled here. In addition, such heating and cooling may be performed only when the tip segment and the limited reuse assembly are located on the charging base. At 1725, temperature information is received from a thermal sensor located near the dispensing chamber containing the substance. Then at 1730, this temperature information is used for control of a temperature controller that adjusts the material temperature.

  In 1735, the actuator shaft is moved to a fixed position. For example, the actuator shaft may be completely retracted in order to secure this fixed position. This home position can be a reference point for the displacement sensor. In other words, the displacement sensor can start measuring the movement of the actuator shaft from its fixed position. At 1740, the actuator shaft is moved until the mechanical coupling interface (which is integral with or connected to the actuator shaft) contacts the plunger interface. In this position, further movement of the actuator shaft will release the substance from the dispensing chamber. When the mechanical coupling interface contacts the plunger interface, the device is ready to inject material into the eye. This step is performed prior to injecting the substance into the eye so that the temperature of the substance can be maintained at an appropriate temperature for injection. For example, the material may be heated or cooled while the tip segment and the limited reuse assembly are on the charging base. If the tip segment and the limited reuse assembly are removed from the charging base, the physician may have only a limited time to perform the injection before the temperature of the material falls outside the proper temperature range. By bringing the mechanical interface into contact with the plunger interface, the injection itself can be performed in a short time.

  At 1745, an input is received indicating that a substance is to be administered to the eye. For example, a physician may press a button to send a signal to the controller indicating that the actuator will be activated for substance administration. At 1750, the dosage information is used to control the actuation of the actuator to administer the appropriate dose of drug at the appropriate rate. The substance will be administered intraocularly only after it is in the proper temperature range. At 1755, information is received from the displacement sensor. This information indicates the movement distance of the actuator shaft. The travel distance of the actuator shaft is correlated with the dosage. As the shaft moves farther, the plunger is displaced by a greater amount and the dosage is increased. At 1760, an indication of the provided dosage is made. For example, the success of an injection where a full amount of drug has been successfully delivered may be indicated by a green lamp or a numerical value (indicating the amount of substance administered on the order of microliters). For failed injections, the amount of substance actually administered is displayed. In 1765, for example, the tip segment is prevented from being reused by blowing a fuse in the tip segment.

  FIG. 18 is a flowchart of one method associated with injecting a substance into the eye according to the principles of the present invention. FIG. 18 represents a method of operating a temperature controller that heats or cools the material in the dispensing chamber while the tip segment and limited reuse assembly is located at the charging station. At 1805, the connection between the tip segment and the limited reuse assembly is first recognized. At 1810, the type of tip segment is confirmed. At 1815, dosage information is received from the tip segment. At 1820, it is determined whether the tip segment and the limited reuse assembly are located on the charging base. If they are not on the charging base, the system waits at 1825 and returns to 1820. If the tip segment and the limited reuse assembly are on the charge bay, at 1830, the temperature controller is activated to change the temperature of the material contained in the dispensing chamber. Next, at 1835, temperature information is received from the thermal sensor. In 1840, this temperature information is used to control the temperature control device.

  FIG. 19 is a flow chart of one method associated with injecting a substance into the eye according to the principles of the present invention. FIG. 19 illustrates a method involved in determining whether an appropriate dose of drug has been administered. First, at 1910, the actuator is controlled based on dosage and dosage rate information. The actuator drives the plunger and dispenses the substance. In 1920, information indicating the movement distance of the actuator shaft is received from the displacement sensor. At 1930, with this distance information, it is determined whether an appropriate amount of drug has been administered. If the actuator shaft has moved the distance necessary to administer the appropriate dose of drug, an indication is made at 1940 that the appropriate dose of drug has been administered. If the actuator axis has not moved the distance necessary to administer the appropriate dose of drug, then in 1950, the actually administered dose is calculated based on the distance actually moved by the actuator axis. Then, at 1960, an indication of the dose administered is made.

  FIG. 20 is a flow chart of one method associated with injecting a substance into the eye according to the principles of the present invention. FIG. 20 relates to a situation where the actuator shaft has stalled. First, at 2010, the actuator is controlled based on dosage and dosage rate information. The actuator drives the plunger and dispenses the substance. In 2020, data is received from the stall sensor. At 2030, this data is used to determine if the actuator shaft has stalled. If the shaft is in a stalled state, the stalled state is displayed in 2040. At 2050, data is received from a displacement sensor indicating the travel distance of the actuator shaft. In 2060, the amount of the drug actually administered based on the distance information is displayed. If the shaft has not stalled, an indication is made at 2070 that the correct dose of drug has been administered.

  From the foregoing, it will be appreciated that the present invention provides an improved system and method for administering an accurate amount of a substance into the eye. The present invention provides a single-use, disposable dispensing device tip segment that can be dispensed in precise doses. The tip segment is compatible with a limited reuse assembly. Although the invention has been described herein by way of example, various modifications may be made by those skilled in the art.

  Although described above in the context of a disposable dispensing device, the present invention encompasses any disposable medical device device that can be coupled to a power source. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It should be understood that the specification and examples are merely exemplary, with the true scope and spirit of the invention set forth in the following claims.

Claims (47)

  A limited reuse assembly for an ophthalmic handpiece comprising an actuator having a shaft, a power source for supplying power to the actuator, a controller for controlling the actuator, and attached to the shaft at one end A mechanical coupling interface having a mating surface; and a housing that at least partially encloses the power source, the controller, and the actuator, wherein the limited reuse assembly is detachable from a disposable injection device. And reuse limited assembly.   The assembly of claim 1, further comprising a set of interface connectors disposed on an interface surface of the limited reuse assembly.   The assembly of claim 2, wherein the set of interface connectors provides power to a tip segment.   The assembly of claim 2, wherein the set of interface connectors provides power to a temperature control device.   The assembly of claim 2, wherein the set of interface connectors connects the controller to a thermal sensor.   The assembly of claim 2, wherein the set of interface connectors connects the controller to a storage device.   7. The assembly of claim 6, wherein data regarding tip segment status is sent to the controller through the set of interface connectors.   The assembly of claim 6, wherein dosage data is communicated to the controller via the set of interface connectors.   The assembly of claim 8, wherein the dosage data is used to control the actuator.   The assembly of claim 6, wherein temperature data is sent to the controller through the set of interface connectors.   The assembly of claim 10, wherein the temperature data is used to control a temperature controller.   The assembly of claim 1 further comprising a stall sensor for detecting whether the actuator is experiencing a stall condition and an interface for connecting the stall sensor to the controller.   The assembly according to claim 1, further comprising a displacement sensor for measuring a moving distance of the actuator shaft, and an interface for connecting the displacement sensor to the controller.   The assembly of claim 1, wherein the power source is a battery.   The assembly according to claim 1, wherein the actuator is a step motor.   The assembly of claim 1, wherein the actuator is a spring drive mechanism.   The assembly of claim 1, wherein the actuator shaft is rigidly connected to the mechanical coupling interface.   The assembly of claim 1, wherein the actuator shaft is coupled to the mechanical coupling interface via a ball joint.   The assembly of claim 1, further comprising a power controller for monitoring the status of the power source.   The assembly of claim 1, further comprising an electrical contact disposed on a bottom surface of the limited reuse assembly for interfacing with a charging base.   21. The assembly of claim 20, wherein the electrical contact is an electronic type interface.   The assembly of claim 1, further comprising an inductive element disposed near a bottom surface of the limited reuse assembly for interfacing with a charging base.   The assembly of claim 1, further comprising an RFID reader located within the housing, the RFID reader adapted to read information from an RFID tag.   The assembly of claim 1, wherein the controller determines a distance to move the actuator shaft and the mechanical coupling interface to deliver a predetermined dose of material.   The assembly of claim 1, wherein the controller actuates the actuator such that the actuator shaft moves at a constant speed.   The assembly of claim 1, wherein the controller actuates the actuator such that the actuator shaft moves at a variable speed.   The assembly of claim 1, further comprising an indicator disposed on the housing for providing information regarding a status of the limited reuse assembly.   28. The assembly of claim 27, wherein the indicator is a display.   A limited reuse assembly for an ophthalmic handpiece comprising an actuator having a shaft, a power source for supplying power to the actuator, a controller for controlling the actuator, and an end attached to the shaft A mechanical coupling interface having a mating surface, a set of interface connectors provided on the interface surface of the limited reuse assembly, a displacement sensor for measuring the travel distance of the actuator shaft, and the displacement sensor An interface for connecting to the controller, a housing that at least partially encloses the power source, the controller, and the actuator, and an indicator disposed on the housing and providing information regarding a state of the limited reuse assembly Have, before Controller, limited reuse assembly, characterized in that the predetermined dose of substance is the actuator to be supplied to the eye so as to drive the actuator shaft, controlling the operation of the actuator.   30. The assembly of claim 29, wherein the set of interface connectors provides power to a tip segment.   30. The assembly of claim 29, wherein the set of interface connectors connect the controller to a thermal sensor.   30. The assembly of claim 29, wherein the set of interface connectors connect the controller to a storage device.   33. The assembly of claim 32, wherein data regarding the state of the tip segment is communicated to the controller via the interface connector set.   33. The assembly of claim 32, wherein dosage data is communicated to the controller via the interface connector set.   35. The assembly of claim 34, wherein the dosage data is used to control the actuator.   30. The assembly of claim 29, wherein temperature data is communicated to the controller via the set of interface connectors.   The assembly of claim 36, wherein the temperature data is used to control a temperature controller.   30. The assembly of claim 29, further comprising a stall sensor for detecting whether the actuator is experiencing a stall condition and an interface for connecting the stall sensor to the controller.   30. The assembly of claim 29, wherein the power source is a battery.   The actuator is selected from the group consisting of a step motor, a DC motor, a DC motor with a rotation sensor coupled to a linear drive, and a DC motor coupled to a linear drive with a linear sensor. 30. The assembly of claim 29.   30. The assembly of claim 29, wherein the actuator is a spring drive mechanism.   30. The assembly of claim 29, wherein the actuator shaft is rigidly connected to the mechanical coupling interface.   30. The assembly of claim 29, wherein the actuator shaft is coupled to the mechanical coupling interface via a ball joint.   30. The assembly of claim 29, further comprising an RFID reader located within the housing, the RFID reader being adapted to read information from an RFID tag.   30. The assembly of claim 29, wherein the controller actuates the actuator such that the actuator shaft moves at a constant speed.   30. The assembly of claim 29, wherein the controller actuates the actuator such that the actuator shaft moves at a variable speed.   30. The assembly of claim 29, wherein the indicator is a display.

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