Ophthalmic Injection System

• US 20090036846A1
• Filed: 08/01/2007
• Published: 02/05/2009
• Est. Priority Date: 05/17/2006
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: Santos, Cesario Dos, Lind, Casey, Foster, James, Sanchez, Robert, Pinedjian, Raffi, Dacquay, Bruno
• Granted Patent: US 7,887,521 B2
• Time in Patent Office: Days
• US Class Current: 604/290
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02

Abstract

An ophthalmic injection system has a tip segment attachable to and removable from a limited reuse assembly. The tip segment has a dispensing chamber housing, a plunger, a needle, a temperature control device, a thermal sensor, and a first housing at least partially enclosing the dispensing chamber housing, the temperature control device and the plunger. The limited reuse assembly 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 second housing at least partially enclosing the power source, the controller, and the actuator. The mechanical linkage interface is coupled to the actuator shaft and has a mating surface on one end. The substance is injected after the temperature of the substance is altered.

Claims

53. An ophthalmic injection system comprising:

a tip segment attachable to and removable from a limited reuse assembly;

the tip segment comprising;

a dispensing chamber housing having an inner surface and an outer surface, the inner surface partially defining a dispensing chamber for holding a quantity of a substance;

a plunger engaged with the inner surface of the dispensing chamber housing, the plunger capable of sliding in the dispensing chamber housing, the plunger fluidly sealed to the inner surface of the dispensing chamber housing, the plunger having a plunger interface;

a needle fluidly coupled to the dispensing chamber;

a temperature control device at least partially surrounding the dispensing chamber housing, the temperature control device for altering a temperature of the substance in the dispensing chamber;

a thermal sensor located near the dispensing chamber housing, the thermal sensor for measuring a temperature near the dispensing chamber housing;

a pair of tip interface connectors located on an interfacing surface of the tip segment; and

a first housing at least partially enclosing the dispensing chamber housing, the temperature control device and the plunger the limited reuse assembly comprising;

an actuator having a shaft;

a power source for providing power to the actuator;

a controller for controlling the actuator;

a mechanical linkage interface coupled to the shaft, the mechanical linkage interface having a mating surface on an end, the mating surface for interfacing with the plunger interface;

a pair of limited reuse assembly interface connectors located on an interfacing surface of the limited reuse assembly;

a displacement sensor for measuring a distance the actuator shaft travels;

an interface for connecting the displacement sensor to the controller; and

a second housing at least partially enclosing the power source, the controller, and the actuator;

wherein the substance is injected after the temperature of the substance is altered.

1. An ophthalmic injection system comprising:

a tip segment attachable to and removable from a limited reuse assembly;

the tip segment comprising;

a dispensing chamber housing having an inner surface and an outer surface, the inner surface partially defining a dispensing chamber for holding a quantity of a substance;

a plunger engaged with the inner surface of the dispensing chamber housing, the plunger capable of sliding in the dispensing chamber housing, the plunger fluidly sealed to the inner surface of the dispensing chamber housing, the plunger having a plunger interface;

a needle fluidly coupled to the dispensing chamber;

a temperature control device at least partially surrounding the dispensing chamber housing, the temperature control device for altering a temperature of the substance in the dispensing chamber; and

a first housing at least partially enclosing the dispensing chamber housing, the temperature control device and the plunger

the limited reuse assembly comprising;

an actuator having a shaft;

a power source for providing power to the actuator;

a controller for controlling the actuator;

a mechanical linkage interface coupled to the shaft, the mechanical linkage interface having a mating surface on an end, the mating surface for interfacing with the plunger interface; and

a second housing at least partially enclosing the power source, the controller, and the actuator;

wherein the substance is injected after the temperature of the substance is altered.

2. The system of claim 1 wherein the tip segment further comprises:

a thermal sensor located near the dispensing chamber housing, the thermal sensor for measuring a temperature.

3. The system of claim 2 wherein the thermal sensor is selected from the group consisting of a thermocouple and a thermistor.

4. The system of claim 2 wherein the thermal sensor measures a temperature of the substance.

5. The system of claim 2 wherein a temperature of the substance is extrapolated from a temperature measured near the dispensing chamber housing.

6. The system of claim 2 further comprising:

an interface connecting the thermal sensor to the controller.

7. The system of claim 6 wherein the controller uses the temperature information to control the temperature control device.

8. The system of claim 6 wherein the controller uses the temperature information to control an injection of the substance.

9. The system of claim 1 wherein the temperature control device is a heater.

10. The system of claim 1 wherein the temperature control device is a cooling device.

11. The system of claim 1 wherein the temperature control device is a combination heating/cooling device.

12. The system of claim 1 wherein the limited reuse assembly further comprises:

a stall sensor for detecting if the actuator is experiencing a stall condition; and

an interface for connecting the stall sensor to the controller.

13. The system of claim 1 wherein the limited reuse assembly further comprises:

a displacement sensor for measuring a distance the actuator shaft travels; and

an interface for connecting the displacement sensor to the controller.

14. The system of claim 1 wherein the power source is a battery.

15. The system of claim 1 wherein the actuator is selected from the group consisting of a stepper motor, a DC motor, a DC motor with a rotary sensor coupled to a linear drive, and a DC motor coupled to a linear drive with a linear sensor.

16. The system of claim 1 wherein the actuator is a spring driven mechanism.

17. The system of claim 1 wherein the actuator shaft is rigidly connected to the mechanical linkage interface.

18. The system of claim 1 wherein the actuator shaft is coupled to the mechanical linkage interface via a ball and socket joint.

19. The system of claim 1 wherein the tip segment further comprises:

a pair of tip interface connectors located on an interfacing surface of the tip segment.

20. The system of claim 19 wherein the limited reuse assembly further comprises:

a pair of limited reuse assembly interface connectors located on an interfacing surface of the limited reuse assembly.

21. The system of claim 20 wherein when the pair of tip interface connectors is coupled to the pair of limited reuse assembly interface connectors, the tip segment is electrically coupled to the limited reuse assembly.

22. The system of claim 19 wherein the tip segment further comprises:

a fuse electrically connected to the pair of tip interface connectors.

23. The system of claim 22 wherein the fuse is blown thus preventing further use of the disposable injection device.

24. The system of claim 19 wherein the temperature control device is electrically coupled to the pair of tip interface connectors.

25. The system of claim 1 wherein the power source provides power to the tip segment.

26. The system of claim 1 wherein the power source provides power to the temperature control device.

27. The system of claim 1 wherein the tip segment further comprises:

a memory device.

28. The system of claim 27 wherein the memory device is connected to a pair of tip interface connectors.

29. The system of claim 27 in which the controller interfaces with the memory device.

30. The system of claim 27 wherein the memory device includes data about a condition of the tip segment.

31. The system of claim 30 wherein the controller uses the data about a condition of the tip segment to control an operation of the tip segment.

32. The system of claim 27 wherein the memory device includes dosage data.

33. The system of claim 32 wherein the controller uses the dosage data to control an operation of the tip segment.

34. The system of claim 32 wherein the controller uses the dosage data to control an operation of the actuator.

35. The system of claim 32 wherein the controller uses the dosage data to control an operation of the temperature control device.

36. The system of claim 1 wherein the controller determines a distance to move the plunger to deliver a dosage of the substance.

37. The system of claim 1 wherein the controller operates the actuator so that the actuator shaft moves at a fixed rate.

38. The system of claim 1 wherein the controller operates the actuator so that the actuator shaft moves at a variable rate.

39. The system of claim 27 wherein the memory device is embodied in an RFID tag located near an interfacing surface of the disposable injection device.

40. The system of claim 39 wherein the limited reuse assembly further comprises:

an RFID reader located near an interfacing end of the limited reuse assembly, the RFID reader adapted to read information from the RFID tag.

41. The system of claim 1 wherein the plunger is press-fitted onto a rigid shaft, and the plunger interface is located on a proximal end of the shaft.

42. The system of claim 1 wherein the plunger is over-molded onto a rigid shaft, and the plunger interface is located on a proximal end of the shaft.

43. The system of claim 1 wherein the tip segment further comprises:

first and second tabs located on an interfacing surface of the tip segment, the first and second tabs for securing the tip segment to the limited reuse assembly.

44. The system of claim 43 wherein the limited reuse assembly further comprises:

first and second slots located on an interfacing surface of the limited reuse assembly, the first and second slots for receiving the first and second tabs to secure the tip segment to the limited reuse assembly.

45. The system of claim 1 wherein the tip segment further comprises:

a luer for securing the needle to the dispensing chamber housing.

46. The system of claim 1 wherein the plunger interface has a shape that mates with a shape on an end of the mechanical linkage mechanism.

47. The system of claim 1 wherein motion is transferred from the mechanical linkage interface to the plunger only in a single dispensing direction.

48. The system of claim 1 wherein the substance is a drug for treating a condition of the eye.

49. The system of claim 1 wherein the limited reuse assembly further comprises:

a power source controller for monitoring a condition of the power source.

50. The system of claim 1 wherein the limited reuse assembly further comprises:

an indicator located on the housing, the indicator for providing information about a status of the limited reuse assembly.

51. The assembly of claim 50 wherein the indicator is a display.

52. The system of claim 1 wherein an initial amount of the substance is preloaded in the dispensing chamber and a dosage of the substance comprising less than the initial amount is delivered by movement of the plunger in the dispensing chamber.

54. The system of claim 53 further comprising:

an interface connecting the thermal sensor to the controller.

55. The system of claim 54 wherein the controller uses the temperature information to control the temperature control device.

56. The system of claim 54 wherein the controller uses the temperature information to control an injection of the substance.

57. The system of claim 53 wherein the thermal sensor is selected from the group consisting of a thermocouple and a thermistor.

58. The system of claim 53 wherein the temperature control device is a heater.

59. The system of claim 53 wherein the temperature control device is a cooling device.

60. The system of claim 53 wherein the temperature control device is a combination heating and cooling device.

61. The system of claim 53 wherein the limited reuse assembly further comprises:

a stall sensor for detecting if the actuator is experiencing a stall condition; and

an interface for connecting the stall sensor to the controller.

62. The system of claim 53 wherein the power source is a battery.

63. The system of claim 53 wherein the actuator is selected from the group consisting of a stepper motor, a DC motor, a DC motor with a rotary sensor coupled to a linear drive, and a DC motor coupled to a linear drive with a linear sensor.

64. The system of claim 53 wherein the actuator is spring driven mechanism.

65. The system of claim 53 wherein the actuator shaft is rigidly connected to the mechanical linkage interface.

66. The system of claim 53 wherein the actuator shaft is coupled to the mechanical linkage interface via a ball and socket joint.

67. The system of claim 53 wherein when the pair of tip interface connectors is coupled to the pair of limited reuse assembly interface connectors, the tip segment is electrically coupled to the limited reuse assembly.

68. The system of claim 53 wherein the tip segment further comprises:

a fuse electrically connected to the pair of tip interface connectors.

69. The system of claim 68 wherein the fuse is blown thus preventing further use of the disposable injection device.

70. The system of claim 53 wherein the tip segment further comprises:

a memory device.

71. The system of claim 70 wherein the memory device is connected to the pair of tip interface connectors.

73. The system of claim 71 wherein the controller interfaces with the memory device.

74. The system of claim 73 wherein the controller uses the data about a condition of the tip segment to control an operation of the tip segment.

79. The system of claim 53 wherein the controller determines a distance to move the plunger to deliver a dosage of a substance.

80. The system of claim 53 wherein the controller operates the actuator so that the actuator shaft moves at a fixed rate.

81. The system of claim 53 wherein the controller operates the actuator so that the actuator shaft moves at a variable rate.

82. The system of claim 70 wherein the memory device is embodied in an RFID tag located near an interfacing surface of the disposable injection device.

83. The system of claim 82 wherein the limited reuse assembly further comprises:

an RFID reader located near an interfacing end of the limited reuse assembly, the RFID reader adapted to read information from the RFID tag.

84. The system of claim 53 wherein motion is transferred from the mechanical linkage interface to the plunger only in a single dispensing direction.

85. The system of claim 53 wherein the substance is a drug for treating a condition of the eye.

86. The system of claim 53 wherein an initial amount of the substance is preloaded in the dispensing chamber and a dosage of the substance comprising less than the initial amount is delivered by movement of the plunger in the dispensing chamber.

73-1. The system of claim 70 wherein the memory device includes data about a condition of the tip segment.

75. The system of claim 72 wherein the memory device includes dosage data.

76. The system of claim 75 wherein the controller uses the dosage data to control an operation of the tip segment.

77. The system of claim 75 wherein the controller uses the dosage data to control an operation of the actuator.

78. The system of claim 75 wherein the controller uses the dosage data to control an operation of the temperature control device.