Ophthalmic drug delivery system

• US 7,883,031 B2
• Filed: 05/20/2004
• Issued: 02/08/2011
• Est. Priority Date: 05/20/2003
• Status: Active Grant

• Current Assignee: Optimyst Systems Inc.
• Original Assignee: James F. Collins Jr
• Inventors: Chinnock, Randal B., Howard, Joseph, Collins, James F. Jr., Melanson, Jeffrey
• Primary Examiner(s): Tran; Len
• Assistant Examiner(s): Boeckmann; Jason J
• Application Number:
  US10/851,611
• Publication Number:
  US 20040256487A1
• Time in Patent Office: 2,455 Days
• Field of Search: 2391021-1022, 239/375, 239/378, 239/338, 239/329, 239/330, 239/71, 239/74, 239/360, 222/64, 222/66, 222/639, 222/642, 310/327, 310/326, 251/129.06, 128/200.14, 128/200.16
• US Class Current: 239/338
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/041 using heaters
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 11/065 using steam as driving gas
• CPC Class Codes: A61M 2205/59 Aesthetic features, e.g. distraction means to prevent fears of child patients
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: B05B 17/0623 coupled with a vibrating horn
• CPC Class Codes: B05B 17/0646 Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto
• CPC Class Codes: B05B 17/0676 Feeding means

Abstract

A fluid atomizer is disclosed. The fluid atomizer comprises a body having a proximal end and a distal end. A removable reservoir containing a fluid disposed therein is connected to the body. A discharge plate is disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough. An ultrasonic oscillator is disposed in the body for transmitting the fluid from the reservoir to the discharge plate and through the plurality of openings, wherein transmission of the fluid through the plurality of openings atomizes the fluid.

Claims

1. An ophthalmic fluid atomizer configured to deliver an ophthalmic fluid to an eye, the ophthalmic fluid atomizer comprising:

a body having a proximal end and a distal end;

a reservoir connected to the body, wherein the reservoir contains an ophthalmic fluid disposed therein;

a discharge plate disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough;

propulsion means for transmitting the ophthalmic fluid from the reservoir to the discharge plate, wherein transmission of the ophthalmic fluid across the discharge plate generates a plume of ophthalmic fluid along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid atomizer that is physically separate from the propulsion means, from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye;

a processor electronically connected to the propulsion means, wherein the processor controls operation of the propulsion means;

an activation switch operatively coupled to the processor to activate the propulsion means; and

an adjustable dosage adjuster, physically separate from the activation switch, operatively coupled to the processor and configured to adjust discharge duration of the ophthalmic fluid from the propulsion means.

2. The ophthalmic fluid atomizer according to claim 1, wherein the atomizer discharges the ophthalmic fluid having a velocity of between approximately 4 and 30 centimeters per second.

3. The ophthalmic fluid atomizer according to claim 1, wherein the atomizer operates for approximately 0.5 to 5 seconds upon activation of the activation switch.

4. The ophthalmic fluid atomizer according to claim 1, further comprising means for transmitting data between the processor and an external device.

5. The ophthalmic fluid atomizer according to claim 1, further comprising means for operating the atomizer for a period in excess of five seconds.

6. The ophthalmic fluid atomizer according to claim 1, further comprising a low level alert operatively connected to the processor, wherein the low level alert transmits a signal that the ophthalmic fluid is at a low level in the reservoir.

7. The ophthalmic fluid atomizer according to claim 1, further comprising means for adjusting operation of the propulsion means to adjust an amount of the ophthalmic fluid transmitted across the discharge plate.

8. The ophthalmic fluid atomizer according to claim 7, wherein the means for adjusting operation of the propulsion means are operatively connected to the processor.

9. The ophthalmic fluid atomizer according to claim 1, wherein the activation switch is operable among an off position, a first operating position, and a second operating position.

10. The ophthalmic fluid atomizer according to claim 9, wherein, upon engaging the activation switch in the second operating position, the processor transmits an operating signal to the propulsion means for no more than five seconds.

11. The ophthalmic fluid atomizer according to claim 9 wherein, upon engaging the activation switch in the first operating position, the system controller transmits a signal to a user that the device is ready for operation.

12. The ophthalmic fluid atomizer according to claim 9, wherein the first operating position is operatively disposed between the off position and the second position.

13. The ophthalmic fluid atomizer according to claim 9, further comprising an indicator signal operatively coupled to the activation switch and configured to operate when the activation switch is in the first position.

14. The ophthalmic fluid atomizer according to claim 9, wherein the activation switch is configured to operate the propulsion means when the activation switch is in the second position.

15. The ophthalmic fluid atomizer according to claim 9, wherein the activation switch is operatively coupled to the propulsion means and configured to operate the propulsion means for a predetermined period of time independent of a duration of the operation of the activation switch.

16. The ophthalmic fluid atomizer according to claim 1, further comprising a low level alert operatively connected to the processor, wherein the low level alert transmits a signal that the fluid is at a low level in the reservoir.

17. The ophthalmic fluid atomizer according to claim 1, further comprising a flow controller operatively coupled to the processor to adjust flow rate of the ophthalmic fluid from the propulsion means.

18. The ophthalmic fluid atomizer according to claim 17, wherein the flow controller is preprogrammed.

19. The ophthalmic fluid atomizer according to claim 1, wherein the propulsion means extends into the reservoir.

20. The ophthalmic fluid atomizer according to claim 1, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

21. The ophthalmic fluid atomizer according to claim 20, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

22. The ophthalmic fluid atomizer according to claim 1, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

23. The ophthalmic fluid atomizer according to claim 1, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

24. The ophthalmic fluid atomizer according to claim 1, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

25. The ophthalmic fluid atomizer of claim 1, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

26. An ophthalmic fluid atomizer configured to deliver an ophthalmic fluid to an eye the ophthalmic fluid atomizer comprising:

a body having a proximal end and a distal end;

a reservoir connected to the body, wherein the reservoir contains an ophthalmic fluid disposed therein;

a discharge plate disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough;

propulsion means for transmitting the ophthalmic fluid from the reservoir to the discharge plate, wherein transmission of the ophthalmic fluid through the plurality of openings atomizes the ophthalmic fluid and generates a plume of ophthalmic fluid along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid atomizer that is physically separate from the propulsion means, from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye;

a processor electronically connected to the propulsion means, wherein the processor controls operation of the propulsion means; and

an activation switch operatively coupled to the processor and configured to operate the propulsion means for a predetermined period of time, said predetermined period of time having a duration which is independent of operation of the activation switch.

27. The ophthalmic fluid atomizer according to claim 26, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

28. The ophthalmic fluid atomizer according to claim 27, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

29. The ophthalmic fluid atomizer according to claim 26, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

30. The ophthalmic fluid atomizer according to claim 26, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

31. The ophthalmic fluid atomizer of claim 26, wherein the mist contains an amount of ophthalmic medicine and the momentum of the mist is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

32. The ophthalmic fluid atomizer according to claim 26, wherein the atomizer discharges the ophthalmic fluid having a velocity of between approximately 4 and 30 centimeters per second.

33. The ophthalmic fluid atomizer according to claim 26, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

34. The ophthalmic fluid atomizer according to claim 26, wherein the reservoir is removable.

35. An ophthalmic fluid misting device adapted to deliver an ophthalmic fluid to an eye comprising:

a) a body having a proximal end and a distal end;

b) a prime mover coupled to the body;

c) a discharge plate coupled to the distal end of the body;

d) a targeting device mounted on the body for spacing the discharge plate a predetermined distance from the eye;

e) a prefilled medication reservoir releasably coupled to the proximal end of the body, the medication reservoir comprising;

i) a vent having a vent covering comprising a liquid impermeable/gas permeable material,

ii) a seal operable between a closed position prior to coupling the reservoir to the body and an open position when the reservoir is coupled to the body, and

iii) a sterile ophthalmic fluid disposed within the reservoir;

f) a processor operatively coupled to the prime mover for regulating operation of the prime mover;

g) an activation switch operatively coupled to the processor such that a single operation of the activation switch activates the prime mover for a predetermined period of time; and

h) an adjustable dosage adjuster, physically separate from the activation switch, operatively coupled to the processor to operate the prime mover for the predetermined period of time regardless of a duration of the operation of the activation switch, wherein during the predetermined period of time the prime mover and the discharge plate have a structure that generates a plume of ophthalmic fluid in mist form along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid misting device that is physically separate from the prime mover,—

from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye.

36. The ophthalmic fluid misting device according to claim 35, wherein the discharge plate is releasably connected to the body.

37. The ophthalmic fluid misting device according to claim 35, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

38. The ophthalmic fluid misting device according to claim 35, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

39. The ophthalmic fluid misting device according to claim 35, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

40. The ophthalmic fluid misting device of claim 35, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

41. The ophthalmic fluid misting device according to claim 35, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

42. The ophthalmic fluid misting device according to claim 41, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

43. An ophthalmic fluid misting device adapted to deliver an ophthalmic fluid to an eye comprising:

a) a body and a reservoir connected to the body, wherein the reservoir contains an ophthalmic fluid disposed therein;

b) a mover of the ophthalmic fluid coupled to the body;

c) a processor operatively coupled to the mover for regulating operation of the mover;

d) an activation switch operatively coupled to the processor such that a single operation of the activation switch activates the mover for a predetermined period of time;

e) an adjustable dosage adjuster, physically separate from the activation switch, operatively coupled to the processor to operate the mover for the predetermined period of time regardless of a duration of the operation of the activation switch, wherein during the predetermined period of time the mover has a structure that generates a plume of ophthalmic fluid in mist form along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger to at least one of an ocular blink reflex and a lacrimation reflex of the eye, and

f) an output device electronically coupled to the processor, wherein the output device is adapted to receive information from the processor.

44. The ophthalmic fluid misting device according to claim 43, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

45. The ophthalmic fluid misting device according to claim 43, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

46. The ophthalmic fluid misting device according to claim 43, further comprising:

a discharge plate at a distal end of the body; and

means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

47. The ophthalmic fluid misting device of claim 43, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

48. The ophthalmic fluid misting device according to claim 43, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

49. The ophthalmic fluid misting device according to claim 48, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

50. An ophthalmic fluid atomizer comprising:

a body having a proximal end and a distal end;

a reservoir connected to the body, wherein the reservoir contains an ophthalmic fluid disposed therein;

a discharge plate disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough;

an ultrasonic generator located in the body for transmitting the ophthalmic fluid from the reservoir to the discharge plate, wherein the discharge plate and the ultrasonic generator have a structure for generating a plume of ophthalmic fluid along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid atomizer that is physically separate from the ultrasonic generator, from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye;

the ultrasonic generator disposed between the proximal and distal ends and in fluid communication with the reservoir and the discharge plate;

a processor electronically connected to the ultrasonic generator, wherein the processor controls operation of the ultrasonic generator;

an activation switch operatively coupled to the processor to activate the ultrasonic generator;

an adjustable dosage adjuster, physically separate from the activation switch, operatively coupled to the processor, and configured to adjust discharge duration of the ophthalmic fluid from the device; and

a flow controller operatively coupled to the processor to adjust flow rate of the ophthalmic fluid from the ultrasonic generator.

51. The ophthalmic fluid atomizer according to claim 50, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

52. The ophthalmic fluid atomizer according to claim 50, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

53. The ophthalmic fluid atomizer according to claim 50, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

54. The ophthalmic fluid atomizer of claim 50, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

55. The ophthalmic fluid atomizer according to claim 50, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

56. The ophthalmic fluid atomizer according to claim 55, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

57. An ophthalmic fluid atomizer comprising:

a body having a proximal end and a distal end;

a reservoir engaging surface disposed at the distal end for receiving a reservoir containing an ophthalmic fluid disposed therein;

a discharge plate disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough;

an ultrasonic generator located in the body for transmitting the ophthalmic fluid from the reservoir to the discharge plate, wherein the discharge plate and the ultrasonic generator have a structure for generating a plume of ophthalmic fluid along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid atomizer that is physically separate from the ultrasonic generator, from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye;

the ultrasonic generator disposed between the proximal and distal ends and in fluid communication with the discharge plate;

a processor electronically connected to the ultrasonic generator, wherein the processor controls operation of the ultrasonic generator;

an activation switch operatively coupled to the processor to activate the ultrasonic generator; and

an adjustable dosage adjuster, physically separate from the activation switch, operatively coupled to the processor, and configured to adjust discharge duration of the ophthalmic fluid from the device.

58. The ophthalmic fluid atomizer according to claim 57, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

59. The ophthalmic fluid atomizer according to claim 57, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

60. The ophthalmic fluid atomizer according to claim 57, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

61. The ophthalmic fluid atomizer of claim 57, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

62. The ophthalmic fluid atomizer according to claim 57, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

63. The ophthalmic fluid atomizer according to claim 62, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.

64. An ophthalmic fluid atomizer comprising:

a body having a proximal end and a distal end;

a reservoir connected to the body, wherein the reservoir contains an ophthalmic fluid disposed therein;

a discharge plate disposed at the distal end, wherein the discharge plate includes a plurality of openings extending therethrough;

propulsion means for transmitting the ophthalmic fluid from the reservoir to the discharge plate, wherein transmission of the ophthalmic fluid across the discharge plate generates a plume of ophthalmic fluid along a direction directly toward the eye, wherein the plume of ophthalmic fluid travels, without being subject to a dynamic force generated by a mechanical device of the ophthalmic fluid atomizer that is physically separate from the propulsion means, unassisted from the discharge plate to the eye and at the eye has a momentum that has a magnitude that is insufficient to trigger at least one of an ocular blink reflex and a lacrimation reflex of the eye;

a processor electronically connected to the propulsion means, wherein the processor controls operation of the propulsion means;

an activation switch operatively coupled to the processor to activate the propulsion means; and

means for adjusting the flow rate of ophthalmic fluid from the propulsion means.

65. The ophthalmic fluid atomizer according to claim 64, wherein the plume of ophthalmic fluid has a volume that can entirely be retained by the eye.

66. The ophthalmic fluid atomizer according to claim 64, wherein the plume of ophthalmic fluid has a volume of greater than or equal to 1 micro liter and less than or equal to 5 micro liters.

67. The ophthalmic fluid atomizer according to claim 64, further comprising means for spacing the discharge plate a predetermined distance from an eye, wherein the means for spacing the discharge plate comprises at least one light projected toward the eye.

68. The ophthalmic fluid atomizer of claim 64, wherein the plume of ophthalmic fluid contains an amount of ophthalmic medicine and the momentum of the plume is such that substantially all of the amount of ophthalmic medicine is received and retained by the human eye.

69. The ophthalmic fluid atomizer according to claim 64, wherein the ophthalmic fluid is selected from the group consisting of mydriatics/cycloplegics, anesthetics, flourescein, flourescein/anesthetic combinations, mydriatic reversal agents, ophthalmic decongestants, ophthalmic lubricants, and glaucoma medications.

70. The ophthalmic fluid atomizer according to claim 69, wherein the glaucoma medications are selected from the group consisting of prestaglandins, beta blockers, alpha adrenergic agents, carbonic anhydrase inhibitors, and miotics.