JP5215313B2 - Drug encapsulation - Google Patents

Description

This application
US patent application Ser. No. 11 / 581,629 filed Oct. 16, 2006;
US patent application Ser. No. 11 / 581,630, filed Oct. 16, 2006;
US patent application Ser. No. 11 / 581,591, filed Oct. 16, 2006;
US patent application Ser. No. 11 / 435,906 filed May 17, 2006,
Is a continuation-in-part application.
The present invention relates to a medical device, and more particularly, to an infusion device having a drug enclosed therein or a subassembly thereof.

  Several diseases and conditions in the posterior region of the eye are a threat to vision. Age-related macular degeneration (ARMD), choroidal neovascularization (CNV), retinopathy (eg, diabetic retinopathy, vitreoretinopathy), retinitis (eg, cytomegalovirus (CMV) retinitis), uveitis Macular edema, glaucoma, and neuropathy are some examples.

  These and other diseases can be treated by injecting drugs into the eye. Such infusion is usually performed manually using conventional syringes and needles. FIG. 1 is a perspective view of a prior art syringe used to inject a drug 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 rest 130. As is generally known, the drug to be injected is placed in the chamber 115. When the thumb rest 130 is pushed, the plunger 120 releases the drug through the needle 105.

  When using such a syringe, the surgeon pierces the eye tissue with a needle, holds the syringe in a stable state, and (with or without nurse assistance) the syringe. The plunger needs to be activated to inject fluid into the eye. The injection volume is usually not accurately controlled because of the parallax associated with the vernier reading. The flow rate of the fluid is not controlled. Tissue damage can occur due to “unstable” injections. In addition, the drug may flow backward when the needle is removed from the eye.

  Efforts are being made to control the delivery of small amounts of liquid. EFD Inc. located in Providence, Rhode Island. The ULTRA ™ positive displacement dispenser available from the company is one of the commercially available fluid dispensers. ULTRA dispensers are typically used in dispensing small volumes of industrial adhesives. This utilizes a conventional syringe and a custom dispensing tip. An electric stepper motor and working fluid are used to actuate the syringe plunger. In this type of dispenser, the dispense volume is highly dependent on fluid viscosity, surface tension, and dispense tip specifications. Parker Hanifin Corporation, located in Cleveland, Ohio, sells small volume liquid donors for new drug discovery manufactured by Aurora Instruments LLC, located in San Diego, Calif. The Parker / Aurora donor utilizes a piezoelectric donor mechanism. This dispenser is accurate but expensive and requires an electrical signal to be sent to the dispensing mechanism.

  Patent Document 1 discloses a method of injecting a viscous fluid (for example, silicone oil) into an eye in a fluid / fluid exchange during surgery for repairing a retinal detachment or a hiatus, and at the same time, a second viscous fluid (for example, perfluorocarbon). An ophthalmic system for sucking a liquid from the eye is disclosed. The system includes a conventional syringe having a plunger. One end of the syringe is fluidly coupled to a pneumatic source that provides a constant pneumatic pressure to actuate the plunger. The other end of the syringe is fluidly coupled to the infusion cannula via a tube to provide a viscous fluid to be infused.

  It would be desirable to have a handheld handpiece for injecting medication into the eye. Such handpieces can include a limited reuse assembly that can be attached to and removed from a disposable tip. The disposable tip includes a temperature control device such as a drug, a needle for administering the drug, and a heater that changes the temperature of the drug. It would be desirable to have a temperature control device integrated with the temperature sensor in a single assembly to facilitate assembly of the device.

US Pat. No. 6,290,690

  In one embodiment in accordance with the principles of the present invention, the present invention is a dispensing assembly having a dispensing chamber housing, a temperature controller, and a temperature sensor. The dispensing chamber housing has an inner surface, an outer surface, and a wall thickness. The interior surface partially defines a dispensing chamber that receives a quantity of material. The temperature control device at least partially surrounds the dispensing chamber housing. The temperature control device changes the temperature of the substance in the dispensing chamber. The temperature control device and the temperature sensor are disposed on the substrate.

  In another embodiment according to the principles of the present invention, the present invention is a single element temperature control assembly. The assembly includes a temperature controller and a temperature sensor disposed on the substrate. The temperature sensor is disposed on the substrate such that the distance between the temperature sensor and the temperature control device is approximately equal to the distance between the temperature control device and the substance whose temperature is to be changed by the temperature control device. .

  In another embodiment according to the principles of the present invention, the present invention is a dispensing assembly comprising a dispensing chamber housing, a temperature controller, a temperature sensor, and an interface. The dispensing chamber housing has an inner surface, an outer surface, and a wall thickness. The interior surface partially defines a dispensing chamber that receives a quantity of material. The temperature control device at least partially surrounds the dispensing chamber housing. The temperature control device changes the temperature of the substance in the dispensing chamber. The temperature control device and the temperature sensor are disposed on the substrate. An interface is connected to the temperature controller and the temperature sensor. An interface connector is connected to the interface. The distance between the temperature controller and the temperature sensor is approximately equal to the wall thickness of the dispensing chamber housing. The substrate is wrapped around the outer surface of the dispensing chamber housing.

  The foregoing general description and the following detailed description are both for purposes of illustration and description only and are intended to provide a further description of the claimed invention. I want you to understand. Further advantages and objects of the present invention will become apparent from the following description and through practice of the 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, explain the principles of the invention. Useful for.

1 is a perspective view of a prior art syringe. FIG. 1 is one view of an ophthalmic medical device including a disposable tip and limited reuse assembly according to an embodiment of the present invention. FIG. 3 is another embodiment of a limited reuse assembly according to the principles of the present invention. 1 is a cross-sectional view of a disposable tip and limited reuse assembly according to an embodiment of the present invention. FIG. 1 is a cross-sectional view of a disposable tip according to the principles of the present invention. 1 is a cross-sectional view of a dispensing chamber housing assembly according to the principles of the present invention. FIG. 6 is another cross-sectional view of a dispensing chamber housing assembly according to the principles of the present invention. 1 is a diagram of a temperature control device and temperature sensor assembly in accordance with the principles of the present invention. FIG. FIG. 7B is an enlarged view of the temperature controller and temperature sensor assembly of FIG. 7A.

  Reference will now be made in detail to the 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 like parts.

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

  The tip 205 can be connected to and removed from the limited reuse assembly 250. In this embodiment, the tip 205 includes a threaded portion on the interior surface of the housing 215 that is threaded onto the threaded portion 260 of the limited reuse assembly 250. In addition, a locking mechanism 265 secures the tip 215 to the limited reuse assembly 250. The locking mechanism 265 may be in the form of a button, a sliding switch, or a cantilevered mechanism. Other mechanisms for connecting the tip 205 to the limited reuse assembly 250, such as those with structural features that couple together, are generally known in the art and are also within the scope of the present invention. belong to.

  Needle 210 is adapted to dispense a substance, such as a drug, into the eye. Needle 210 can have any generally known configuration. Preferably, needle 210 is designed so that its thermal properties are useful for a particular drug delivery application. For example, when a heated drug needs to be dispensed, the needle 210 may be relatively short (a few millimeters) in length to facilitate proper dispensing of the drug.

  Switch 270 is adapted to provide input to the system. For example, the switch 270 can be used to start the system or to turn on the heater. Other switch, button, or user-operated control inputs are generally known and can also be used with limited reuse assembly 250 and / or tip 205.

  The optional light 275 is lit when the tip 205 is ready for use. The optional light 275 can protrude from the housing 215 or can be stored within the housing 215, in which case the optional light 275 is viewed through a transparent portion of the housing 215. Is possible. In other embodiments, the optional light 275 can be replaced by an indicator such as a liquid crystal display, a segmented display, or other device that reports the status or status of the disposable tip 205. For example, the optional light 275 can be a system error, a full battery charge, a poor battery charge, or a poor connection between the tip 205 and the limited reuse assembly 250, but is not limited thereto. It is also possible to intermittently turn on and off in order to notify the state. Although shown at the top of the tip 205, an optional light 275 or other indicator may be located on the limited reuse assembly 250.

FIG. 3 is another embodiment of a limited reuse assembly according to the principles of the present invention. Limited reuse assembly 250 includes button 3 10 , display 320, and housing 330. A disposable tip 205 is attached to the end 340 of the limited reuse assembly 250. It provides an input to the system buttons 3 10 actuates. Similar to switch 270, button 3 10 can start the heater or other temperature control device, or the operation of the plunger can begin. Display 320 is a liquid crystal display, a partial display, or other device that reports the status or status of disposable tip 205 or limited reuse assembly 250.

  FIG. 4 is a cross-sectional view of a disposable tip and limited reuse assembly according to one embodiment of the present invention. FIG. 4 illustrates how the tip 205 interfaces with the limited reuse assembly 250. In the embodiment of FIG. 4, tip 205 includes plunger interface 420, plunger 415, dispensing chamber housing 425, tip housing 215, temperature controller 450, temperature sensor 460, needle 210, dispensing chamber 405, interface 530, and A tip interface connector 520 is included. Limited reuse assembly 250 includes mechanical linkage interface 545, actuator shaft 510, actuator 515, power supply 505, controller 305, limited reuse assembly housing 255, interface 535, and limited reuse assembly interface connector 525.

  Within the distal end portion 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 fluidly sealed to the inner surface of the dispensing chamber housing 425. A dispensing chamber housing 425 surrounds the dispensing chamber 405. Typically, the dispensing chamber housing 425 has a cylindrical shape. As a result, the dispensing chamber 405 also has a cylindrical shape.

  Needle 210 is fluidly coupled to dispensing chamber 405. In such a case, the substance stored in the dispensing chamber 405 can pass through the needle 210 into the eye. 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 any material stored in the dispensing chamber housing 425 and the dispensing chamber 405. The configurations of the temperature controller 450 and the supply temperature sensor 460 will be described in detail later. An interface 530 connects the temperature controller 450 and the temperature sensor 460 to the tip interface connector 520.

  The components of the tip 205, including the dispensing chamber housing 425, the temperature controller 450, and the plunger 415, are at least partially enclosed by the tip housing 215. In one embodiment in accordance with the principles of the present invention, the plunger 415 is sealed to the interior surface of the dispensing chamber housing 425. This sealing prevents contamination of the material stored in the dispensing chamber 405. Such sealing is desirable for medical purposes. This sealing can be placed at any point on the plunger 415 or dispensing chamber housing 425.

  Within limited reuse assembly 250, power source 505 supplies power to actuator 515. An interface (not shown) between the power supply 505 and the actuator 515 functions as a circuit that supplies power to the actuator 515. The actuator 515 is connected to the actuator shaft 510. When the actuator 515 is a stepper motor, the actuator shaft 510 is integrated with the actuator 515. The mechanical linkage interface 545 is connected to the actuator shaft 510. In this configuration, as the actuator 515 moves the actuator shaft 510 upward toward the needle 210, the mechanical linkage interface 545 also moves upward toward the needle 210.

  Controller 305 is connected to limited reuse assembly interface connector 525 via interface 535. Limited reuse assembly interface connector 525 is disposed on the upper surface of limited reuse assembly housing 255 adjacent to mechanical linkage interface 545. As a result, both limited reuse assembly interface connector 525 and mechanical linkage interface 545 are adapted to be connected to tip interface connector 520 and plunger interface 420, respectively.

  Controller 305 and actuator 515 are connected by an interface (not shown). With this interface (not shown), the controller 305 can control the operation of the actuator 515. Furthermore, the controller 305 can also control the operation of the power supply 505 through an interface between the power supply 505 and the controller 305. In such a case, when the power source 505 is a rechargeable battery, the controller 305 can control charging and discharging of the power source 505.

  The controller 305 is typically an integrated circuit having power, input, and output pins and has the ability to perform logical functions. In various embodiments, the controller 305 is a limited-use device controller. In such a case, the controller 305 performs a specific control function limited to a specific device or component, such as a temperature control device or a power source. For example, the temperature control device controller has a basic function of controlling the temperature control device. In other embodiments, the controller 305 is a microprocessor. In such cases, the controller 305 is programmable so that it can function to control multiple components of the device. In other cases, the controller 305 is not a programmable microprocessor, but instead is a special purpose controller configured to control different components that perform different functions. Although shown as one component, the controller 305 can be comprised of many different components or integrated circuits.

  The tip 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 disposed on the bottom surface of the plunger 415 is adapted to couple with a mechanical linkage interface 545 disposed near the top surface of the limited reuse assembly housing 255. Yes. Further, the tip interface connector 520 is adapted to connect with a limited reuse assembly interface connector 525. When the tip 205 is thus connected to the limited reuse assembly 250, the actuator 515 and the actuator shaft 510 are adapted to drive the plunger 415 upward toward the needle 210. Furthermore, an interface is also formed between the controller 305 and the temperature control device 450. Signals can propagate from the controller 305 toward the temperature controller 450 through the interface 535, limited reuse assembly interface connector 525, tip interface connector 520, and interface 530.

  In operation, the controller 305 controls the operation of the actuator 515 when the tip 205 is connected to the limited reuse assembly 250. When the actuator 515 is activated, the actuator shaft 510 moves upward toward the needle 210. As a result, the mechanical linkage interface 545 coupled to the plunger interface 420 moves the plunger 415 upward toward the needle 210. As a result, the substance placed in the dispensing chamber 405 is released through the needle 210.

  Furthermore, 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. Because the dispensing chamber housing 425 is at least partially thermally conductive, heating or cooling the dispensing chamber housing 425 heats or cools the material disposed in the dispensing chamber 405. The temperature information can be sent from the temperature sensor 460 to the controller 305 via a number of interfaces. Using this temperature information, the operation of the temperature controller 450 can be controlled. When the temperature control device 450 is a heater, the controller 305 controls the amount of current sent to the temperature control device 450. The more current that is sent to the temperature controller 450, the hotter the temperature controller. As a result, the controller 305 can control the operation of the temperature control device 450 using a feedback loop using information from the temperature sensor 460. An arbitrary type of control algorithm such as a PID (Proportional Integral Derivative) algorithm can be used to control the operation of the temperature controller 450.

  FIG. 5 is a cross-sectional view of a disposable tip of an ophthalmic medical device according to an embodiment of the present invention. In FIG. 5, disposable tip 205 includes housing 215, needle 210, plunger 415, plunger interface 420, dispensing chamber 405, dispensing chamber housing 425, temperature controller 450, temperature sensor 460, interface 530, and tip interface connector. 520. The disposable tip 205 operates as a disposable injection device.

  In the embodiment of FIG. 5, the plunger 415 is disposed within the dispensing chamber housing 425. The dispensing chamber 405 is enclosed by a dispensing chamber housing 425 and a plunger 415. Plunger 415 forms a fluid seal with the interior surface of dispensing chamber housing 425. Needle 210 is fluidly coupled to dispensing chamber 405. As a result, the substance disposed in dispensing chamber 405 can contact plunger 415 and can be pushed out of needle 210. The temperature controller 450 is disposed adjacent to the dispensing chamber housing 425 and at least partially surrounds the dispensing chamber 405. The housing 215 forms an outer skin on the disposable tip portion 205.

  In various embodiments of the present invention, the temperature controller 450 is a heating and / or cooling device. The temperature controller 450 is in thermal contact with the dispensing chamber housing 425. Thus, the temperature controller 450 has the ability to change the temperature of the material in the dispensing chamber 450. Interface 530 and tip interface connector 520 couple temperature controller 450 to a limited reuse assembly. In such cases, the temperature controller 450 can be powered and controlled by a limited reuse assembly. In one embodiment of the present invention, the temperature controller 450 receives current from the limited reuse assembly via the interface 530. By supplying a current in one direction (ie, a positive voltage across the device), the temperature controller 450 heats. By supplying current in the opposite direction (ie, a negative voltage across the device), the temperature controller 450 cools.

  The substance to be dispensed into the eye is usually a drug, which is placed in the dispensing chamber 405. As a result, the substance contacts the inner surface of the dispensing chamber housing 425 and one side of the plunger 415. Typically, the dispensing chamber 405 is cylindrical in shape. The temperature controller 450 is in thermal contact with the dispensing chamber housing 425. As a result, the temperature controller 450 is adapted to control the temperature of the contents of the dispensing chamber 425. The temperature sensor 460 provides temperature information to assist in controlling the operation of the temperature controller 450.

  In one embodiment of the present invention, the substance disposed in the dispensing chamber 450 is a drug that is pre-filled in the dispensing chamber. In such a case, the disposable tip 205 is suitable as a disposable product. Such disposable products can be assembled at the factory with a filled dose of drug.

  When prefilling medication into dispensing chamber 405, a set amount of medication can be prefilled. For example, 100 microliters of drug can be filled into the dispensing chamber 405 so that any amount up to 100 microliters can be dispensed. In such a case, the plunger 415 can be moved the exact distance and the correct dose of drug can be dispensed from the dispensing chamber 405 through the needle 210 into the eye. This provides filling flexibility and ease of assembly.

  FIG. 6A is a cross-sectional view of a dispensing chamber housing assembly according to the principles of the present invention. In FIG. 6, the dispensing chamber housing 425 has a substantially cylindrical shape. The dispensing chamber 405 is disposed within a cavity defined at least in part by the interior surface of the dispensing chamber housing 425. A temperature controller 450 at least partially surrounds the dispensing chamber housing 425. Temperature controller 450 and temperature sensor 460 are integrated into a single assembly that is wrapped around the outer surface of dispensing chamber housing 425. In one embodiment of the present invention, the temperature sensor 460 is a thermistor.

  FIG. 6B is a cross-sectional view of a dispensing chamber housing assembly according to the principles of the present invention. This figure is a horizontal section of the embodiment of FIG. 6A (which is a vertical section). In FIG. 6B, the dispensing chamber housing has a generally circular cross section (since its shape is generally cylindrical). The wall thickness of the dispensing chamber housing is “d”. The dispensing chamber 405 is disposed inside the dispensing chamber housing 425. The temperature controller 450 at least partially surrounds the dispensing chamber housing 425. The temperature sensor 460 is disposed adjacent to the dispensing chamber housing 425.

  FIG. 7A shows a temperature control device and a temperature sensor according to an embodiment of the present invention. In FIG. 7A, temperature controller 450 is disposed on a substrate (eg, a flexible printed circuit board or similar structure) as shown. In its simplest form, the temperature control device is a resistive element that generates heat when current is passed through it. The temperature sensor 460 is disposed on the same substrate as the temperature control device 450. Interface 530 and tip interface connector 520 function to link temperature controller 450 and temperature sensor 460 to the limited reuse assembly.

  FIG. 7B is an enlarged view of a part of the temperature control device and the temperature sensor of FIG. 7A. FIG. 7B shows the arrangement of the temperature sensor 460 and the temperature control device 450. The temperature sensor 460 is disposed at a distance “d” from the temperature control device 450. This distance “d” is approximately equal to the thickness of the dispensing chamber housing 425, as shown in FIG. 6B. As a result, the temperature sensor 460 reads a temperature that is approximately equal to the temperature inside the dispensing chamber housing 425. Since the distance “d” is the distance between the temperature controller 450 and both the temperature sensor 460 and the dispensing chamber 405, the temperature sensor 460 is arranged to read a temperature approximating the temperature in the dispensing chamber 450. Yes.

  In view of the foregoing, it can be seen that the present invention provides an improved system for delivering an accurate volume of material to the interior of the eye. The present invention provides a single use disposable dispensing device tip that can dispense a dose of drug. The tip interfaces with a limited reuse assembly. The disposable tip includes an assembly that includes a temperature controller and a temperature sensor. This assembly structure allows easy manufacture and assembly of the device while allowing a reliable injection procedure.

  Although the present invention has been described in the context of a disposable ophthalmic drug delivery device, the present invention encompasses any medical device or infusion device. 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 is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the appended claims.

Claims (19)

In the donor assembly,
A dispensing chamber housing comprising an interior surface, an exterior surface, and a wall thickness, wherein the interior surface partially defines a dispensing chamber that receives a quantity of material;
A temperature control device disposed on a substrate and at least partially surrounding the donor chamber housing, wherein the temperature controller changes the temperature of the substance in the donor chamber;
A temperature sensor disposed on the substrate;
Have a distance between the temperature control device the temperature sensor is substantially equal to the wall thickness of said dispensing chamber housing assembly, characterized in that.   The assembly of claim 1, wherein the dispensing chamber housing is substantially cylindrical in shape. An interface connected to the temperature control device and the temperature sensor;
  An interface connector connected to the interface;
    The assembly of claim 1 further comprising: The assembly of claim 3, wherein power is supplied to the temperature controller through the interface. The assembly of claim 3, wherein temperature information is communicated from the temperature sensor through the interface. The assembly of claim 1, wherein the temperature sensor is a thermistor. The assembly of claim 1, wherein the temperature control device is a heater having a resistive element. The assembly of claim 1, further comprising a needle fluidly coupled to the dispensing chamber. The assembly of claim 1, wherein the substrate is wrapped around an outer surface of the dispensing chamber housing. In an integrated temperature control assembly,
    A substrate,
    A temperature control device disposed on the substrate;
    A temperature sensor disposed on the substrate, wherein a distance between the temperature sensor and the temperature control device is a distance between the temperature control device and a substance whose temperature is to be changed by the temperature control device. A temperature sensor arranged to be approximately equal to
  An assembly characterized by comprising: An interface connected to the temperature control device and the temperature sensor;
  An interface connector connected to the interface;
    The assembly of claim 10, further comprising: The assembly according to claim 10, wherein the temperature sensor is a thermistor. The assembly of claim 10, wherein the temperature control device is a heater having a resistive element. In the donor assembly,
    A dispensing chamber housing comprising an interior surface and an exterior surface, wherein the interior surface partially defines a dispensing chamber that receives a quantity of material, the dispensing chamber housing having a wall thickness. A dispensing chamber housing;
    A temperature control device disposed on a substrate and at least partially surrounding the donor chamber housing, wherein the temperature controller changes the temperature of the substance in the donor chamber;
    A temperature sensor disposed on the substrate;
    An interface connected to the temperature control device and the temperature sensor;
    An interface connector connected to the interface;
  The distance between the temperature controller and the temperature sensor is approximately equal to the wall thickness of the dispensing chamber housing, and the substrate is wrapped around an outer surface of the dispensing chamber housing;
  An assembly characterized by that. 15. The assembly of claim 14, wherein the dispensing chamber housing is substantially cylindrical in shape. The assembly of claim 14, wherein power is supplied to the temperature controller through the interface. The assembly of claim 14, wherein temperature information is communicated from the temperature sensor through the interface. The assembly of claim 14, wherein the temperature sensor is a thermistor. 16. The assembly of claim 15, wherein the temperature control device is a heater having a resistive element.

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