KR20090080975A - Limited reuse assembly for ophthalmic injection device - Google Patents

Abstract

A limited reuse assembly for an ophthalmic medical device has an actuator with a shaft, a power source for providing power to the actuator, a controller for controlling the actuator, a mechanical linkage interface, and a housing. The mechanical linkage interface is coupled to the actuator shaft and has a mating surface on one end. The housing at least partially encloses the power source, the controller, and the actuator. The limited reuse assembly is attachable to and removable from a disposable injection device.

Description

LIMITED REUSE ASSEMBLY FOR OPHTHALMIC INJECTION DEVICE}

Related Applications

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

The present invention relates to disposable medical instruments, and more particularly to a two-piece eye drop dispensing device having a disposable tip comprising an improved plunger linkage and a seal. .

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

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

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

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

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

It would be desirable to have a portable hand piece for injecting medication into the eye, including a relatively inexpensive tip segment that can be attached to or removed from the reusable assembly. Placing sterilized parts while placing more expensive parts, including electronics or drive devices, within the reusable assembly increases the efficiency and cost effectiveness of the drug delivery system. It would be desirable to have a reusable assembly that includes functions and configurations for the infusion process. It would also be desirable to have a disposable tip segment that can be easily attached to a reusable assembly for injection and can be easily removed and discarded after injection. Such a system offers many advantages over prior art injectors.

In one embodiment according to the principles of the present invention, the invention is a finite reuse assembly having an actuator having an axis, a power source for supplying power to the actuator, a controller for controlling the actuator, a mechanical link interface, and a housing . The mechanical link interface is coupled to the actuator axis and has a mating surface on one end. The housing at least partially surrounds the power source, the controller, and the actuator. The finite reuse assembly is attachable to and can be removed from the disposable infusion device.

In another embodiment according to the principles of the present invention, the present invention provides an actuator having an axis, a power source for supplying power to the actuator, a controller for controlling the actuator, a mechanical link interface, a housing, and an indicator. The branch is a finite reuse assembly. A mechanical link interface couples to the actuator axis and has a mating surface on one end. The housing at least partially surrounds the power source, the controller, and the actuator. The indicator is located on the housing and provides information regarding the state of the finite reuse assembly. The actuator drives the actuator shaft to control the operation of the actuator so that a dose of material is delivered to the eye.

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

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

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

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

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

4 illustrates a cross-sectional view of another embodiment of a finite reuse assembly in accordance with the principles of the present invention.

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

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

7 illustrates a cross-sectional view of a disposable tip segment for an ophthalmic medical device according to one embodiment of the present invention.

8 shows a partial view of a finite reuse assembly and cross-sectional view of a disposable tip segment according to one embodiment of the present invention.

9A illustrates a cross-sectional view of a disposable tip segment for an ophthalmic medical device in accordance with one embodiment of the present invention.

9B is an end view of the tip segment of FIG. 9A.

10A-10D schematically illustrate four different circuits that may be included in embodiments of the present invention.

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

12 illustrates a cross-sectional view of a finite reuse assembly according to one embodiment of the present invention.

13 is a cross-sectional view of a finite reuse assembly according to one embodiment of the present invention.

14 and 15 are cross-sectional views of two subassemblies in accordance with the principles of the present invention.

16 is a cross-sectional view of a finite reuse assembly, tip segment, and filling base according to the principles of the present invention.

17A and 17B are flowcharts of one method of injecting material into the eye in accordance with the principles of the present invention.

18 is a flow chart of one method associated with injecting material into the eye in accordance with the principles of the present invention.

19 is a flow chart of one method associated with injecting material into the eye according to the principles of the present invention.

20 is a flow chart of one method associated with injecting material into the eye in accordance with the principles of the present invention.

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

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

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

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

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

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

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

4 illustrates a cross-sectional view of another embodiment of a finite reuse assembly in accordance with 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 located in the housing 255. The upper portion of the housing 255 has a threaded portion 260. The locking device 265, the switch 270, the button 308, and the indicators 306, 307 are all located on the housing 255.

The power source 505 may typically use rechargeable batteries such as lithium ion batteries or other types of batteries. In addition, any type of power cell is suitable as the power source 505. The power source 505 provides power to the system, more specifically the actuator 515. The power source 505 also provides power to the tip segment that is connected to the finite reuse assembly 250. In such a case, the power source 505 may provide power to a temperature control device (not shown) located within the tip segment. Optionally, power source 505 may be removed from housing 255 through a door or other similar shape (not shown).

Interface 517 is typically an electrical conductor that allows power to flow from power source 505 to actuator 515. As with interface 517, other interfaces may be arranged to provide power to other parts of the system.

Actuator shaft 510 is connected to and driven by actuator 515. Actuator 515 is typically a stepper motor or other type of motor capable of moving the actuator shaft 510 a precise distance. In one embodiment, the actuator shaft 510 is connected to a tip segment that delivers the drug to the eye via a mechanical linkage. In this case, actuator 515 is a stepper motor capable of precisely moving shaft 510 to deliver the correct amount of drug to the eye. Actuator 515 is secured to the inner surface of housing 255 by, for example, tabs that engage the outer surface of actuator 515.

In another embodiment, actuator 515 is a linear actuator or linear driver. In this case, the actuator 515 may be a spring or spring driven mechanism, a geared DC motor with a rotary sensor connected to a linear driver or a DC motor coupled to a linear drive with a linear sensor, or a linear stepper motor. have. Other types of motors, such as rotary permanent magnet motors, may be used as the actuator 515.

The locking device 265, the switch 270, and the button 308 are all disposed on the housing 255 and can be operated by hand. Similarly, indicators 306 and 307 can also be disposed and viewed on housing 255. The locking device 265, the switch 270, the buttons 308, and the indicators 306, 307 may be connected to a controller (not shown) via an interface (not shown) located within the housing 255.

5 shows a cross section of a disposable tip segment and a finite reuse assembly according to one embodiment of the invention. 5 shows how tip segment 205 connects to finite reuse assembly 250. In the embodiment of FIG. 5, the tip segment 205 includes an assembly 555, a plunger interface 420, a plunger 415, a dosage chamber housing 425, a tip segment housing 215, a temperature control device 450, Thermal sensor 460, needle 210, dosing chamber 405, interface 530, and tip interface connector 453. The finite reuse assembly 250 includes a mechanical link interface 545, an actuator shaft 510, an actuator 515, a power source 505, a controller 305, a finite reuse assembly housing 255, an interface 535, and Finite reuse assembly interface connector 553.

In tip segment 205, plunger interface 420 is located on one end of plunger 415. The other end of the plunger 415 forms one end of the dosage chamber 405. The plunger 415 is configured to slide in the dosing chamber 405. The outer surface of the plunger 415 is fluid seal to the inner surface of the dosage chamber housing 425. Dosing chamber housing 425 surrounds dosing chamber 405. Typically, the dosage chamber housing 425 has a cylindrical shape. Thus, the dosing chamber 405 also has a cylindrical shape. In tip segment 205, assembly 555 includes any number of components, as described below.

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

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

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

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

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

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

Tip segment 205 is configured to attach to or mate with finite reuse assembly 250. In the embodiment of FIG. 5, the plunger interface 420 located on the bottom surface of the plunger 415 is configured to mate with the mechanical link interface 545 located near the top surface of the finite reuse assembly housing 255. Tip interface connector 453 is also configured to connect with finite reuse assembly interface connector 533. When tip segment 205 is connected to finite reuse assembly 250 in this manner, actuator 515 and actuator shaft 510 are adjusted to drive plunger 415 upward toward needle 210. In addition, an interface is formed between the controller 305 and the temperature control device 450. Signals can be communicated from the controller 305 to the temperature control device 450 via the interface 535, finite reuse assembly interface connector 553, tip interface connector 453, and interface 530.

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

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

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, disposable tip segment 205 includes housing 215, needle 210, plunger 415, plunger interface 420, dosing chamber 405, dosing chamber housing 425, assembly 555, Temperature control device 450, thermal sensor 460, optional luer 430, tip interface connectors 451, 452, 453, and interfaces 461, 462, 463. Disposable tip segment 205 works like a disposable injection device.

In the embodiment of FIG. 6, the plunger 415 is located in the dosage chamber housing 425. Dosing chamber 405 is surrounded by plunger 415 and dosing chamber housing 425. The plunger 415 forms a fluid seal with the inner surface of the dosing chamber housing 425. The needle 210 couples in fluid communication with the dosing chamber 405. In this manner, material located within the dosage chamber 405 is pushed out of the needle 210 in contact with the plunger 415. Needle 210 may be secured or permanently attached to disposable tip segment 205 by an optional luer 430. The temperature control device 450 is disposed on the dosage chamber housing 425 and at least partially surrounds the dosage chamber 405. Housing 215 forms an outer skin on disposable tip segment 205.

In various embodiments of the present invention, temperature control device 450 is a heating and / or cooling device. The temperature control device 450 is in thermal contact with the dosage chamber housing 425. This allows the temperature control device 450 to change the temperature of the material in the dosing chamber 405.

In FIG. 6, plunger 415 includes an O-ring. The O-ring seals against the inner surface of the dosing chamber housing 425. In this manner, a hermetic seal is maintained to prevent contamination of material in the dosing chamber 405. Plunger 415 may be made of any suitable material, for example glass, stainless steel, or polymer. O-rings are typically made of rubber or polymer. Other types of seals may be used. For example, the plunger 415 may include an annular ring disposed around the circumference of the plunger 415 such that the annular ring contacts the inner surface of the dosage chamber housing 425. This annular ring may seal the plunger against the inner surface of the dosage chamber housing 425. In this case, the annular ring may be integral with the plunger 415, and the plunger 415 may be made of rubber or polymer. Plunger interface 420 may be manufactured in any suitable shape. For example, the plunger interface may be substantially dish-shaped as shown, or may be substantially flat, conical, or spherical. It may also include a lip or other similar feature.

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

Assembly 555 may include any number of different components. In one embodiment assembly 555 includes a fuse that is blown after disposable tip segment 205 is used or when a heat button is actuated. In this manner the fuse prevents reuse of the disposable tip segment 205. In another embodiment, assembly 555 may include information regarding the type of disposable tip segment 205, dosage information, temperature information, plunger movement information, or the manner in which disposable tip segment 205 operates or the disposable tip. Memory device that stores any type of information that identifies a characteristic of the segment 205. In another embodiment, an assembly 555 may be configured to store a representation of data, such as a NAND flash IC, a hard-wired memory device such as an RFID tag, a series of fuses and resistors connected in parallel. Circuits or other types of devices.

The substance to be delivered to the eye, typically the medication, is located in the dosing chamber 405. In this manner, the medication contacts one surface of the plunger 415 and the inner surface of the dosage chamber housing 425. The temperature control device 450 is in thermal contact with the dosage chamber housing 425. In this manner the temperature control device 450 is configured to control the temperature of the contents of the dosing chamber 405.

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

The thermal sensor 460 provides temperature information to assist in controlling the operation of the temperature control device 450. The thermal sensor 460 can be located near the dosage chamber housing 425 and measure the temperature near the dosage chamber housing 425. The thermal sensor 460 may be positioned in thermal contact with the dosing chamber housing 425, in which case the thermal sensor measures the temperature of the dosing chamber housing 425. In other embodiments, the temperature measured by thermal sensor 460 may be correlated with the temperature of the material in dosing chamber 405. That is, a measurement of the temperature of the dosing chamber housing 425 can be used to calculate the temperature of the material located within the dosing chamber 405. Since the thermal properties of the dosing chamber housing 425 and the materials therein are known and the temperature of the temperature control device 450 is controllable, the temperature of the material in the dosing chamber 405 is applied when the temperature control device is applied for a specified time. The change can be calculated. Thermal sensor 460 may be any number of different devices capable of providing temperature information. For example, thermal sensor 460 may be a thermocouple or resistive device whose resistance varies with temperature.

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

When the medication is pre-injected into the dosing chamber 405, a set amount of medication may be pre-injected. For example, 100 microliters of medication may be introduced into the dosing chamber 405 and any amount up to 100 microliters may be dosed. Information regarding the amount of medication in the medication chamber 405 and other medication information may be stored in the assembly 555. In this case, the plunger 415 may move at the correct distance to deliver the correct dose of medication from the dosing chamber 405 through the needle 210 to the eye. This will provide flexibility in dosage and ease of assembly.

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

The embodiment of FIG. 7 functions similarly to the embodiment of FIG. 6. Several parts of the tip segment 205 of FIG. 7 have the same characteristics as the parts of FIG. 6 and operate in substantially the same manner. The locking mechanism 471 is used to attach the tip segment 205 to the finite reuse assembly. A mating mechanism on the finite reuse assembly, such as locking mechanism 265, is attached to locking mechanism 471 to secure tip segment 205 to the finite reuse assembly.

8 shows a partial view of a finite reuse assembly and cross-sectional view of a disposable tip segment according to one embodiment of the present invention. In FIG. 8, disposable tip segment 205 includes housing 215, needle 210, plunger 415, plunger interface 420, dosing chamber 405, dosing chamber housing 425, RFID tag 1110. , Temperature control device 450, tip interface connector 452, and interface 462. A partial view of the finite reuse assembly includes a mechanical link interface 545, an actuator axis 510, an interface 535, a finite reuse assembly interface connector 552, an RFID reader 1120, and an RFID interface 1130. It is shown.

The embodiment of FIG. 8 functions like the embodiment of FIGS. 6 and 7. Several parts of the tip segment 205 of FIG. 8 have the same characteristics as the parts of FIGS. 6 and 7 and operate in substantially the same manner. However, the embodiment of FIG. 8 uses an RFID system rather than using a wired assembly 555 to store and convey information. The RFID reader 1120 is located near the top of the finite reuse assembly adjacent to the mechanical link interface 545. The RFID tag is located under the tip segment 205. The RFID reader 1120 is configured to read information from the RFID tag 1110. The RFID interface 1130 is connected to a controller 305 (not shown).

The RFID tag 1110 is configured to hold information of the same type as the information that the assembly 555 maintains in the embodiments of FIGS. 5-7. In this manner, the RFID tag 1110 is another type of memory. However, as is generally known, the RFID tag 1110 need not be wired to the RFID reader 1120. In this manner, a wireless connection may be made between the tip segment 205 (RFID tag 1110) and the finite reuse assembly (RFID reader 1120).

In a passive RFID system, one type of RFID system, the RFID tag 1110 has no power supply. Instead, passive RFID tags rely on their power on the electromagnetic fields generated by RFID readers. 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. This small current allows the RFID tag 1110 to operate. In such a passive system the RFID tag is configured to receive power from the electromagnetic field emitted by the RFID reader 1120 and to send outgoing signals received at the RFID reader 1120.

In operation, an RFID reader antenna (not shown) transmits the signals 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 powers the RFID tag 1110. The RFID tag 1110 may then transmit a signal to the RFID reader antenna and the RFID reader 1120 itself via the RFID tag antenna. In this manner, the RFID tag 1110 and the RFID reader 1120 are able to communicate with each other via a radio frequency link. The RFID tag 1110 transmits information such as medication information or tip segment information to the RFID reader 1120 through the RFID tag antenna. This information is received by the RFID reader 1120. In this way, information can be transferred from the tip segment 205 to the finite reuse assembly. The RFID reader 1120 may send information to the RFID tag 1110 in a similar manner. For example, the RFID reader 1120 may transmit information such as medication information through a radio frequency signal emitted by the RFID reader 1120. The RFID tag 1110 receives the radio frequency signal with information. The RFID tag 1110 may then store this information.

Although the embodiment of FIG. 8 is shown having an RFID system, any other type of wireless system may be used to convey information between tip segment 205 and finite reuse assembly 250. For example, a Bluetooth protocol can be used to establish a communication link between the tip segment 205 and the finite reuse assembly 250. Information may be communicated between the tip segment 205 and the finite reuse assembly 250 via this communication link. Other embodiments used to convey information include infrared protocols, 802.11, fire wire, or other wireless protocols.

In one embodiment, the RFID tag 1110 (or assembly 555) includes medication information. Appropriate dosage information for the medication stored in the dosage chamber 405 may be included in the RFID tag 1110 (or assembly 555). In such a case, the controller 305 can read the dosage information from the RFID tag 1110 (or assembly 555) and operate the actuator 515 in a manner suitable for delivering a suitable dosage. For example, 100 microliters can be stored in the dosing chamber 405. Information that a dosage of 20 microliters should be delivered to the eye may be stored in the RFID tag 1110 (or assembly 555). In this case, the controller 305 reads the dosage information from the RFID tag 1110 (or assembly 555) (a 20 microliter dose must be delivered to the eye). Controller 305 may then actuate actuator 515 to deliver a dosage of 20 microliters. The controller 305 can cause the actuator 515 to move the actuator shaft 510 and the mechanical link interface 545 to a set distance associated with a dosage of 20 microliters. In this case, the plunger 415 moves to this set distance so that exactly 20 microliters of medication is released from the needle 210 into the eye.

In another embodiment in accordance with the principles of the present invention, the controller 305 may calculate the distance that the plunger 415 must travel to deliver the desired dosage. For example, if controller 305 reads dosage information about a 20 microliter drug dosage from RFID tag 1110 (or assembly 555), controller 305 uses this information to plunger 415. Calculates the proper distance that must travel. Knowing the volume of the dosing chamber 405 and the volume of the drug introduced into the dosing chamber 405, the distance at which the plunger 415 must travel to deliver the required dose can be calculated at the controller 305. If the dosing chamber 405 has a cylindrical shape, the volume of the dosing chamber can be calculated by multiplying the cross-sectional area (circle area) of the cylinder by the height of the dosing chamber. This simple mathematical formula can be used to calculate the total volume of the dosage chamber 405. Since the cross-sectional area of the dosing chamber 405 is constant for any given situation, a height corresponding to the distance the plunger 415 travels can be calculated for any dose.

For example, suppose that 100 microliters of drug are introduced into the dosing chamber 405 and that the cross-sectional area of the dosing chamber 405 is 10. If the dosing chamber 405 is cylindrical, the height of the cylinder is also 10. In order to deliver a dose of 20 microliters corresponding to 20% of the total volume of the dosing chamber 405, the plunger 415 must be moved upwards 2 toward the needle 210. That is, a dosage of 20 microliters corresponds to 20% of the total volume of the dosage chamber 405. In this case, the plunger 415 must move up towards the needle 210 by a distance corresponding to 20% of the overall height of the dosing chamber 405. The controller 305 thus controls the actuator 515 such that the actuator shaft 510 moves the plunger 415 over a distance of 20% of the overall height of the dosing chamber 405.

In addition, the controller 305 may read information about the speed at which the plunger 415 must travel to properly deliver the single dose. In such a case, the controller 305 reads information about the drug delivery rate from the RFID tag 1110 (or assembly 555) and uses this information to cause the actuator 515 to pull the plunger 415 at that rate. Operate to drive. The speed at which the plunger 415 moves can be fixed or variable. In some cases, it may be necessary to move the plunger 415 faster than in other cases. For example, if the drug stored in the dosing chamber 405 is a drug that must be heated before being injected into the eye, the plunger 415 is driven at a rate that prevents the heated drug from cooling and blocking the needle 210. It would be desirable. In other cases, it may be necessary to move the plunger 415 slowly to improve delivery of the medication stored in the dosing chamber 405.

The RFID tag 1110 (or assembly 555) may also include any other type of information related to the delivery of the drug. For example, the RFID tag 1110 (or assembly 555) may include information regarding the type of drug contained within the dosing chamber 405, the various properties of the drug, or other properties of the proper delivery or proper dosage of the drug. It may contain �ž�. In addition, RFID tag 1110 (or assembly 555) may include safety information, information regarding proper operation of tip segment 205, or any other information regarding tip segment or finite reuse assembly.

In another embodiment according to the principles of the present invention, a healthcare professional taking a medication may select a dosage. In such cases, the physician may select the desired drug dosage by an input device (not shown) located on the finite reuse assembly 250 or tip segment 205. In such a case, the controller 305 operates the actuator 515 to move the plunger 415 to the distance necessary to receive the desired drug dosage and deliver the desired dosage. Such user selectable dosage regimes can be implemented simply by adding additional input devices.

It may be desirable to include dosage information in the RFID tag 1110 (or assembly 555) to avoid dosage errors. In such a case, a number of different drug delivery tip segments 205 will be manufactured with the drug injected at the factory. Dosage information may be loaded on the RFID tag 1110 (or assembly 555) at the factory. In such a case, a number of different tip segments, each having the same amount of medication stored in the dosing chamber 405 but with different dosing information stored in the RFID tag 1110 (or assembly 555), can be manufactured and shipped. . The physician can then order the disposable tip segment 205 with the necessary dosage information on the RFID tag 1110 (or assembly 555). Packaging may be clearly categorized to confirm dosage information so that appropriate dosages are taken to the patient.

9A illustrates a cross-sectional view of a disposable tip segment for an ophthalmic medical device in accordance with one embodiment of the present invention. In FIG. 9, disposable tip segment 205 includes housing 215, needle 210, plunger 415, plunger shaft 417, plunger interface 420, dosing chamber 405, dosing chamber housing 425. , Assembly 555, temperature control device 450, thermal sensor 460, optional luer 430, tip interface connectors 452 and 453, interfaces 462 and 463, and tab 472, 473).

The various parts of 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, which engage a slot of a finite reuse assembly. After these two tabs 472 and 473 have been inserted into the slot, the tip segment 205 rotates to lock the tip segment into position on the finite reuse assembly. The two tabs 472, 473 can have different shapes or sizes to provide a suitable interface between the tip segment 205 and the finite reuse assembly. If these two tabs 472 and 473 have different shapes or sizes from each other, the tip segment 205 fits on the finite reuse assembly in only one direction. In other embodiments of the present invention, tabs of different shapes or sizes may be used with slots of different shapes or sizes on different finite reuse assemblies. In this manner, a number of different finite reuse assemblies may be manufactured with slots of different shapes or sizes to accommodate tip segments 205 having tabs of complementary shapes or sizes.

In addition, the embodiment of FIG. 9 includes a plunger shaft 417 coupled to the plunger 415. In such an embodiment, the plunger 415 may be over-mold on the plunger shaft 417. Plunger shaft 417 has a generally cylindrical shape whose central diameter is smaller than the diameter on its proximal and distal ends. Plunger interface 420 is a surface on the proximal end of plunger shaft 417. Plunger shaft 417 is typically made of a rigid material, such as stainless steel. Plunger 415 is made of rubber or polymeric material. In another embodiment of the present invention, the distal end of the plunger shaft 417 has a lip to which the plunger 415 can be attached. Plunger 415 may be press-fitted on plunger shaft 417 and held in place by a lip on the distal end of plunger shaft 417. This facilitates assembly. Instead of overmolding the plunger 415 on the shaft, the plunger 415 can be made of a separate component and pushed over the distal end of the plunger shaft 417. Plunger interface 420 may be any suitable shape.

9B is an end view of the tip segment of FIG. 9A. 9B shows the end furthest from the needle 210 of the tip segment 205. This end connects with a finite reuse assembly. Housing 215, plunger interface 420, tip interface connectors 451, 452, 453, 454, 455, 456, tabs 472, 473, and alignment slots 481 are shown.

In the embodiment of FIG. 9B, one end of the plunger interface 420 is not fully circular. It is a flat part configured to align with a mechanical link interface having a similar cross-sectional shape. This optional shape is designed to allow proper alignment of the tip segment with the finite reuse assembly. In another embodiment 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 to assist in proper alignment between the tip segment and the finite reuse assembly. Alignment slot 481 connects with an alignment pin (shown 581 in FIG. 11) on the finite reuse assembly. In other embodiments of the present invention, tabs 472 and 473 have different sizes. Alternatively, the tabs 472 and 473 can have different shapes. The two tabs 472, 473 also connect with the slots 572, 573 of FIG. 11 to assist in the alignment of the finite reuse assembly and tip segment.

In one embodiment according to the principles of the present invention, the tip segments are disposed on a finite reuse assembly such that tabs 472 and 473 are inserted into slots 572 and 573. The tip segment then rotates relative to the finite reuse assembly such that tabs 472 and 473 remain in slots 572 and 573. Alignment pins 581 and alignment slots 481 are then properly aligned.

Connectors 451, 452, 453, 454, 455, 456 electrically link tip segments to finite reuse assemblies. Connectors 451, 452, 453, 454, 455, 456 connect to each of similar connectors 551, 552, 553, 554, 556, 557 on a finite reuse assembly (see FIG. 11). These connectors provide a passageway for the signal to travel between the tip segment and the finite reuse assembly.

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

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

10C shows one of several different configurations for fuse 1011. Fuse 1011 may be included within assembly 555 or may be implemented as shown in FIG. 10C. In FIG. 10C, fuse 1011 is connected between connectors 453 and 456. In this embodiment, the fuse 1011 operates to ensure that the tip segment is a single-use device. The fuse 1011 is blown after the heating button is activated or the disposable tip segment 205 is used. As noted above, the controller in the finite reuse assembly detects when the connected tip segment has been used and causes an increased current to flow through the fuse 1011 to blow the fuse. If the fuse 1011 is blown, the tip segment will no longer work and should be discarded.

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

Various other configurations of connectors 451, 452, 453, 454, 455, 456 can be implemented. For example, six connectors are shown but any number of connectors may be implemented. In addition, any combination of different circuits may be included within the tip segment.

11 is an end view of a finite reuse assembly in accordance with the principles of the present invention. The end of the finite reuse assembly shown in FIG. 11 connects with the end of the tip segment shown in FIG. 9B. An end view of the finite reuse assembly shown in FIG. 11 is a finite reuse assembly housing 255, a mechanical link interface 545, finite reuse assembly interface connectors 551, 552, 553, 554, 556, 557, slots 572, 573, and alignment pin 581.

In the embodiment of FIG. 11, one end of the mechanical link interface 545 is not fully circular. It has a flat portion designed to align with the plunger interface having a similar cross-sectional shape. This optional shape is designed to allow proper alignment between the tip segment and the finite reuse assembly. In another embodiment of the present invention, the cross section of one end of the mechanical link interface 545 is circular.

The embodiment of FIG. 11 also includes an optional alignment pin 581 to assist in proper alignment of the tip segment with the finite reuse assembly. Alignment pins 581 connect with alignment slots (shown 481 in FIG. 9B) on the tip segment. In another embodiment of the present invention, the slots 572 and 573 have different sizes. Alternatively, the slots 572 and 573 can have different shapes. The two slots 572, 573 also assist in the alignment of the fin segments with the finite reuse assembly by connecting with the tabs 472, 473 of the tip segment shown in FIG. 9B.

Connectors 551, 552, 553, 554, 556, 557 electrically link the tip segments to the finite reuse assembly. Connectors 551, 552, 553, 554, 556, 557 connect with connectors 451, 452, 453, 454, 455, 456 on the tip segment (as shown in FIG. 9B). Such a connector provides a passage through which a signal can pass between the tip segment and the finite reuse assembly.

12 illustrates a cross-sectional view of a finite reuse assembly according to one embodiment of the present invention. In FIG. 12, finite reuse assembly 250 includes mechanical link interface 545, actuator shaft 510, actuator 515, power source 505, controller 305, finite reuse assembly housing 255, interface 535, finite reuse assembly interface connector 551, displacement sensor 1215, power source controller 444, and inductive member 1225.

Displacement sensor 1215 measures the movement of actuator shaft 510. The displacement sensor may in particular be an optical rotary encoder, a linear encoder, a current sensing circuit (Hall sensor), a rotary potentiometer, or a linear potentiometer. In another embodiment, the displacement sensor may detect whether actuator 515 is stopped. For example, the hall sensor can detect an increase in current consumption of the actuator 515, which indicates a stopped state. In addition, the displacement sensor 1215 can measure a back EMP from the actuator 515. The displacement sensor 1215 may be made of a single part or a plurality of parts. In one embodiment in accordance with the principles of the present invention, the displacement sensor 1215 includes a device for measuring the distance the actuator axis 510 moves and a device for detecting whether the actuator 515 has stopped.

The displacement sensor 1215 measures the position of the actuator shaft 510. Since the mechanical link interface 545 is connected to the actuator shaft 510, the displacement sensor 1215 also measures the position of the mechanical link interface 545. This displacement sensor 1215 can be used to determine if the total dose has been delivered. When the displacement sensor 1215 detects that the actuator shaft 510 has moved a certain distance corresponding to the movement of the mechanical link interface 545 and the plunger 415, it can be seen that a certain dose is released from the needle 210. Can be. In the case where the medication is to be delivered to the eye, the displacement sensor 1215 provides information about the movement of the actuator shaft 510, which information can be used to determine whether the overall dosage has been delivered.

In some cases, the actuator 515 may stop and prevent the actuator shaft 510, the mechanical link interface 545, and the plunger 415 from driving at a suitable distance to deliver the entire dose to the eye. In this case, the displacement sensor 1215 measures the distance the actuator axis 510, the mechanical link interface 545, and the plunger 415 have moved. From this distance information, the amount of drug delivered can be calculated. For example, if the dosing chamber 405 is cylindrical, the circular cross-sectional area can be seen. The distance measured by the displacement sensor 1215 then becomes the height of the cylinder, and the displacement volume can be easily calculated (eg in the controller 305). The amount delivered in this way may be displayed via a display device, such as display 320 (of FIG. 3), with a stall indication.

Displacement sensor 1215 may also provide other information useful for the drug delivery process. For example, when the tip segment is connected to a finite reuse assembly, the actuator axis 510 can be withdrawn or moved to its homed position for connection of the tip segment. The displacement sensor 1215 can measure the movement of the actuator shaft 510 to this original position. The actuator shaft 510 may be placed in its original position so that the tip segment may be attached to a finite reuse assembly or prior to delivery of the drug. In one embodiment, the information read from the displacement sensor 1215 is used to confirm that the actuator shaft 510 is in its original position before the actuator 515 is actuated to deliver medication to the eye.

The embodiment of FIG. 12 also includes a power source controller 444 and an inductive member 1225. These two components control the charging of the power source 505 when the power source 505 is a rechargeable battery, for example. The power source controller 444 includes circuitry capable of performing any number of different functions related to the maintenance, monitoring, and charging of the power source 505. In other embodiments, power source controller 444 may be implemented within controller 305 or integrated within controller 305.

In one embodiment of the present invention, power source controller 444 (or controller 305 in some circumstances) counts the number of times the finite reuse assembly 250 has been used. After this count has reached a predetermined safe use count, the finite reuse assembly 250 will not operate. Alternatively, power source controller 444 (or in some cases controller 305) counts the number of times power source 505 has been charged (the number of charge cycles experienced by power source 505). When this count number reaches a predetermined limit, the finite reuse assembly 250 will not operate. In one embodiment of the present invention, power source controller 444 (or controller 305 in some circumstances) detects a fault condition or other instability of power source 505.

To charge the power source 505, a current is induced in the inductive member 1225 when the flowable member 1225 is disposed near another inductive member in a charging base (not shown). This induced current charges the power source 505.

13 is a cross-sectional view of a finite reuse assembly according to one embodiment of the present invention. In FIG. 12, finite reuse assembly 250 includes mechanical link interface 545, actuator shaft 510, actuator 515, power source 505, controller 305, finite reuse assembly housing 255, interface ( 535, finite reuse assembly interface connector 551, displacement sensor 1215, power source controller 444, and charging contacts 1235.

In the embodiment of FIG. 13, charging contacts 1235 contact on a charging base (not shown) to provide power to power source 505. In one embodiment, the charging contacts 1235 are USB type connections such as those used in portable electronic devices having docking stations. In one embodiment, a Molex® CradleCon ^™ connector is used. Other types of connectors may be used.

14 and 15 are cross-sectional views of two subassemblies in accordance with the principles of the present invention. Each of these subassemblies shows the path from the actuator 515 to the needle 210. FIG. 14 shows a mechanical link interface 545 rigidly connected to the actuator shaft 510, while FIG. 15 shows a mechanical link interface 545 with a ball joint 805. The use of the ball joint 805 assists in the alignment of the mechanical link interface 545 with the plunger interface 420.

In FIG. 14, the actuator 515 has an actuator shaft 510 rigidly connected to the mechanical link interface 545. The mechanical link interface is mated with the plunger interface 420. Plunger 415 is disposed within dosing chamber housing 425 and sealed against an interior surface of dosing chamber housing 425. The dosage chamber 405 is defined by the distal face of the plunger 415 and the inner surface of the dosage chamber housing 425. The temperature control device 450 at least partially surrounds the dosage chamber housing 425. The needle 210 couples in fluid communication with the dosing chamber 405.

In FIG. 15, the actuator 515 has an actuator shaft 510 connected to the shaft 810 via a ball joint. The mechanical link interface 545 is rotatably connected to the shaft 810 via a ball joint 805. The mechanical link interface is mated with the plunger interface 420. Plunger 415 is disposed within dosing chamber housing 425 and sealed against an interior surface of dosing chamber housing 425. The dosage chamber 405 is defined by the distal face of the plunger 415 and the inner surface of the dosage chamber housing 425. The temperature control device 450 at least partially surrounds the dosage chamber housing 425. The needle 210 couples in fluid communication with the dosing chamber 405.

In FIGS. 14 and 15, the actuator 515 drives the actuator shaft 510 upwards (in the direction toward the needle 210). Subsequently, the mechanical link interface 545 is also driven up. When the mechanical link interface 545 is mated with the plunger interface 420, the plunger 410 also moves up. The material stored in the dosing chamber 405 is released through the needle 210. In this way, force and motion are transmitted from the actuator shaft 510 to the plunger 415 via the mechanical link interface 545.

If the dosing chamber 405 stores medication to be delivered to the eye, the configuration of FIGS. 14-15 prevents reflux when the needle is removed from the eye. Movement of the plunger 415 takes place in a single direction (in the direction of discharging the drug in the dosing chamber 405). If the mechanical link interface 545 is moved away from the 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 link interface 545, the plunger 415 does not retract when the mechanical link interface 545 retracts.

16 is a cross-sectional diagram of the finite reuse assembly and filling base of FIG. 13. In FIG. 16, the bottom surface of the finite reuse assembly 250 connects with the filling base 1615. Once the finite reuse assembly 250 is placed in the charging base 1615, the power source 505 can be charged. After being filled, the finite reuse assembly 250 can be removed from the filling base 1615. In one embodiment of the present invention, the finite reuse assembly 250 to which the tip segment 205 is attached is disposed within the filling base 1615 and the material located within the dosing chamber 405 is heated by the temperature control device 450 or Is cooled. In this manner, charging base 1615 provides power to temperature control device 450. Once the material located in the dosing chamber 405 reaches a suitable temperature (as determined from the information from the thermal sensor 460), the finite reuse assembly 250 to which the tip segment 205 is attached can be removed from the filling base. Can be. This saves the power source 505 for the implantation process when the finite 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 material into the eye in accordance with the principles of the present invention. At step 1705, a connection between the tip segment and the finite reuse assembly is recognized. In step 1710, the type of tip segment connected to the finite reuse assembly is identified. For example, the type of drug delivery tip segment or drug delivery tip segment can be identified. This identification process can be done by reading information from the tip segment, for example by reading information from a memory or RFID tag. In step 1715, medication information is received from the tip segment. As with the information about the tip segment type, the medication information may be read from the memory device in the tip segment by a controller, RFID reader, or similar device in the finite reuse assembly.

In step 1720, the temperature control device is operated to change the temperature of the material located within the dosing chamber. Such materials may be heated or cooled as described above. In addition, heating or cooling takes place only when the tip segment and the finite reuse assembly are located on the filling base. In step 1725, temperature information is received from a thermal sensor near the dosing chamber in which the substance is located. In step 1730, this temperature information is used to control the temperature control device to adjust the temperature of the material.

In step 1735, the actuator axis moves to its homed position. For example, the actuator axis may be fully retracted to form its original position. The original position forms the reference point for the displacement sensor. In other words, the displacement sensor starts a measurement of the movement of the actuator axis from this reference position. In step 1740, the actuator shaft moves until the mechanical link interface (integral with or coupled to the actuator shaft) contacts the plunger interface. In this position, any further movement of the actuator shaft will cause material to exit the dosing chamber. Once the mechanical link interface is in contact with the plunger interface, the device is ready to be used for injecting material into the eye. This step takes place prior to injecting the substance into the eye so that the substance can be maintained at a temperature suitable for infusion. For example, the material can be heated or cooled while the tip segment and finite reuse assembly are located on the fill base. Once the tip segment and finite reuse assembly are removed from the filling base, the surgeon must perform the injection within a limited time so that the temperature of the material does not fall outside the proper temperature range. If the mechanical link interface comes in contact with the plunger interface, the injection should be performed in a short time.

At step 1745, input is received indicating that the material has been delivered to the eye. For example, the physician may indicate that the actuator will be activated to deliver material by pressing a button that signals the controller. In step 1750, dosage information is used to control the operation of the actuator to deliver the appropriate dosage at a suitable rate. The material is only delivered to the eye after it is in the proper temperature range. In step 1755 information is received from the displacement sensor. This information represents the distance traveled by the actuator axis. The distance traveled by the actuator axis is correlated with the dosage. The farther the shaft moves, the more the plunger moves, and the higher the dose delivered. In step 1760, an indication of the delivered dose is provided. For example, a successful infusion, in which the total dosage is successfully delivered, may be indicated by green light or a number (in microliters indicating the amount of material delivered). For wrong injections, the amount of material actually delivered is indicated. In step 1765, reuse of the tip segment is prevented, for example, by blowing a fuse in the tip segment.

18 is a flow chart of one method associated with injecting material into the eye in accordance with the principles of the present invention. 18 illustrates a method of operating a temperature control device to heat or cool a material located in a dosing chamber while a tip segment and a finite reuse assembly are located in a filling station. In step 1805, the connection between the tip segment and the finite reuse assembly is recognized. In step 1810, the type of tip segment is identified. In step 1815, medication information is received from the tip segment. In step 1820, it is determined whether the tip segment and the finite reuse assembly are located on the filling base. If they are not located on the charging base, at step 1825, the system waits and returns to step 1820. Once the tip segment and the finite reuse assembly are located on the filling base, at step 1830, the temperature control device operates to change the temperature of the material stored in the dosing chamber. In step 1835, temperature information is received from the thermal sensor. In step 1840, this temperature information is used to control the temperature control device.

19 is a flow chart of one method associated with injecting material into the eye according to the principles of the present invention. 19 illustrates a method associated with determining whether an appropriate dosage was delivered. In step 1910, the actuator is controlled based on the dosage and dosage rate information. The actuator moves the plunger to deliver the substance. In step 1920, information indicative of the distance the actuator axis has moved is received from the displacement sensor. In step 1930, this distance information is used to determine if an appropriate dosage has been delivered. If the actuator axis has moved the distance required to deliver the appropriate dosage, then at step 1940, an indication is provided that the appropriate dosage has been delivered. If the actuator axis did not move the distance needed to deliver the appropriate dose, then at step 1950, the delivered dose is calculated based on the distance the actuator axis has moved. In step 1960, an indication of the delivered dose is provided.

20 is a flow chart of one method associated with injecting material into the eye in accordance with the principles of the present invention. 20 relates to the state in which the actuator axis has stopped. In step 2010, the actuator is controlled based on the dosage and dosage rate information. The actuator moves the plunger to deliver the substance. At step 2020, data is received from a stall sensor. In step 2030, this data is used to determine if the actuator has stopped. If the axis has stopped, at step 2040 an indication of the stopped state is provided. At step 2050, a signal is received from the displacement sensor indicating the distance the actuator axis has moved. In step 2060, an indication of the delivered dose is provided based on distance information. If the axis has not stopped, in step 2070 an indication is provided that the appropriate dosage has been delivered.

From the above, it will be appreciated that the present invention provides an improved system and method for delivering the correct volume of material to the eye. The present invention provides a single-use, disposable delivery device tip segment that can deliver an accurate dosage. The tip segment connects with a finite reuse assembly. The invention is illustrated by way of example herein, and various modifications may be made by those skilled in the art to which the invention pertains.

Although the present invention has been described with reference to a single drug delivery device, the present invention encompasses any single medical device that connects to an electrical power source. Other embodiments of the present invention will be apparent to those of ordinary skill in the art in view of the practice and description of the invention disclosed herein. The description and examples of the present invention are intended to be considered by way of example only, and the true scope and spirit of the present invention will be indicated by the following claims.

Claims (47)

A finite reusable assembly for an ophthalmic hand piece, An actuator having an axis; A power source for providing power to the actuator; A controller for controlling the actuator; A mechanical link interface coupled to the shaft, the mechanical link interface having a mating surface at one end; And A housing at least partially surrounding the power source, the controller, and the actuator; Including, The finite reuse assembly is attachable to and removable from a disposable infusion device, Finite reuse assembly. The method of claim 1, Further comprising a pair of interface connectors located on a connection surface of the finite reuse assembly; Finite reuse assembly. The method of claim 2, Wherein the pair of interface connectors provide power to the tip segment, Finite reuse assembly. The method of claim 2, The interface connector pair provides power to a temperature control device, Finite reuse assembly. The method of claim 2, The interface connector pair connects the controller to a thermal sensor, Finite reuse assembly. The method of claim 2, The interface connector pair connects the controller to a memory device, Finite reuse assembly. The method of claim 6, Information about the status of the tip segment is transmitted to the controller via the interface connector pair. Finite reuse assembly. The method of claim 6, Dosing data is communicated to the controller via the interface connector pair; Finite reuse assembly. The method of claim 8, The dosage data is used to control the actuator, Finite reuse assembly. The method of claim 6, Temperature data is communicated to the controller via the interface connector pair; Finite reuse assembly. The method of claim 10, The temperature data is used to control the temperature control device, Finite reuse assembly. The method of claim 1, A stop sensor for detecting whether the actuator is in a stopped state; And An interface for connecting the stop sensor to the controller; Further comprising, Finite reuse assembly. The method of claim 1, A displacement sensor for measuring a distance traveled by the actuator axis; And An interface for connecting the displacement sensor to the controller; Further comprising, Finite reuse assembly. The method of claim 1, The power source is a battery, Finite reuse assembly. The method of claim 1, The actuator is a stepper motor, Finite reuse assembly. The method of claim 1, The actuator is a spring driven mechanism, Finite reuse assembly. The method of claim 1, Wherein the actuator shaft is rigidly connected to the mechanical link interface, Finite reuse assembly. The method of claim 1, The actuator shaft is coupled to the mechanical link interface by a ball and socket joint, Finite reuse assembly. The method of claim 1, Further comprising a power source controller for monitoring the status of the power source, Finite reuse assembly. The method of claim 1, An electrical contact located on the bottom surface of the finite reuse assembly, further comprising an electrical contact for connecting with a charging base; Finite reuse assembly. The method of claim 20, The electrical contact is an electronic-type interface, Finite reuse assembly. The method of claim 1, An inductive member located near the bottom surface of the finite reuse assembly, further comprising an inductive member for connecting with a filling base; Finite reuse assembly. The method of claim 1, An RFID reader disposed within the housing, the RFID reader further configured to read information from the RFID tag, Finite reuse assembly. The method of claim 1, The controller determines a distance for moving the actuator axis and the mechanical link interface to deliver a dose of material, Finite reuse assembly. The method of claim 1, The controller actuates the actuator to cause the actuator axis to move at a fixed speed, Finite reuse assembly. The method of claim 1, The controller actuates the actuator to cause the actuator axis to move at a variable speed, Finite reuse assembly. The method of claim 1, An indicator located on the housing, the indicator further comprising an indicator for providing information regarding the state of the finite reuse assembly; Finite reuse assembly. The method of claim 27, The indicator is a display, Finite reuse assembly. A finite reusable assembly for an ophthalmic hand piece, An actuator having an axis; A power source for providing power to the actuator; A controller for controlling the actuator; A mechanical link interface coupled to the shaft, the mechanical link interface having a mating surface at one end; An interface connector pair located on a connection surface of the finite reuse assembly; A displacement sensor for measuring a distance traveled by the actuator axis; An interface for connecting the displacement sensor to the controller; A housing at least partially surrounding the power source, the controller, and the actuator; And An indicator located on said housing, said indicator for providing information regarding a state of said finite reuse assembly; Including, Wherein the controller controls the operation of the actuator such that the actuator drives the actuator shaft to deliver a dose of material to the eye, Finite reuse assembly. The method of claim 29, Wherein the pair of interface connectors provide power to the tip segment, Finite reuse assembly. The method of claim 29, The interface connector pair connects the controller to a thermal sensor, Finite reuse assembly. The method of claim 29, The interface connector pair connects the controller to a memory device, Finite reuse assembly. 33. The method of claim 32, Information about the status of the tip segment is transmitted to the controller via the interface connector pair. Finite reuse assembly. 33. The method of claim 32, Dosing data is communicated to the controller via the interface connector pair; Finite reuse assembly. The method of claim 34, wherein The dosage data is used to control the actuator, Finite reuse assembly. The method of claim 29, Temperature data is communicated to the controller via the interface connector pair; Finite reuse assembly. The method of claim 36, The temperature data is used to control the temperature control device, Finite reuse assembly. The method of claim 29, A stop sensor for detecting whether the actuator is in a stopped state; And An interface for connecting the stop sensor to the controller; Further comprising, Finite reuse assembly. The method of claim 29, The power source is a battery, Finite reuse assembly. The method of claim 29, Wherein the actuator is selected from the group consisting of a stepper 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, Finite reuse assembly. The method of claim 29, The actuator is a spring driven mechanism, Finite reuse assembly. The method of claim 29, Wherein the actuator shaft is rigidly connected to the mechanical link interface, Finite reuse assembly. The method of claim 29, The actuator shaft is connected to the mechanical link interface by a ball and socket joint, Finite reuse assembly. The method of claim 29, An RFID reader disposed within the housing, the RFID reader further configured to read information from the RFID tag, Finite reuse assembly. The method of claim 29, The controller actuates the actuator to cause the actuator axis to move at a fixed speed, Finite reuse assembly. The method of claim 29, The controller actuates the actuator to cause the actuator axis to move at a variable speed, Finite reuse assembly. The method of claim 29, The indicator is a display, Finite reuse assembly.

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