METHOD AND OPHTHALMIC DEVICE WITH ACTIVE AGENT RELEASE SYSTEM

• US 20150305931A1
• Filed: 04/24/2015
• Published: 10/29/2015
• Est. Priority Date: 04/25/2014
• Status: Abandoned Application

• Current Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Inventors: Pugh, Randall B., Snook, Sharika, Martin, Anthony W.
• Application Number:
  US14/696,126
• Publication Number:
  US 20150305931A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3538 using electrical conduction through the body of the patient
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The present invention provides an energized ophthalmic device with an active agent release system and an associated method. The active agent release system can be suitable to dispense an active agent including, for example, a vitamin, lubricant, a saline, a solvent, and/or medicament, at one or more predetermined times, through the use of an energization element contained in the ophthalmic device. The energization element may be a battery and/or an energy receptor antenna. The release of the active agent can be according to a signal received wirelessly, a predetermined time, and/or a sensed condition, which can cause an activation element to conduct a current to at least a portion of a metal cap under stress causing it to fold and thereby expose the active agent to a surrounding environment.

Claims

1. An ophthalmic device with an active agent release system comprising:

a substrate having one or more containment cells, wherein at least one of the one or more containment cells contains an active agent enclosed by a metal cap bonded under stress to a surface of the substrate; and

an energy source in electrical connection to an activation element configured to conduct an electrical current to at least a portion of the metal cap upon receipt of an activation signal,

wherein the electrical current and the stress cause the metal cap to fold and thereby expose the active agent to an ophthalmic environment of a user.

2. The ophthalmic device of claim 1, additionally comprising:

a micro-processor in electrical connection with the energy source, and

an antenna,

wherein the processor is configured to wirelessly receive, using the antenna, one or more activation signals from a wireless device.

3. The ophthalmic device of claim 2, wherein the wireless device includes one or more of:

a smart phone, a tablet, a personal computer, a remote transmitter, and a medical drug delivery device.

4. The ophthalmic device of claim 1, additionally comprising:

a micro-processor in electrical connection with one or more sensors;

wherein the substrate, the micro-processor, and the one or more sensors form a digital microarray configured to be energized by the energy source.

5. The ophthalmic device of claim 4, wherein the one or more sensors include a biosensor configured to measure the concentration of one or more biomarkers contained in ocular fluid, and to send an activation signal when the measured concentration falls outside a predetermined range.

6. The ophthalmic device of claim 4, wherein the micro-processor includes a timing element configured to provide the activation signal to cause at least one of the one or more metal caps to fold and thereby dispense the active agent at a pre-determined time.

7. The ophthalmic device of claim 4, wherein at least one of the one or more sensors is configured to determine when the ocular surface is above a comfortable dryness level.

8. The ophthalmic device of claim 4, wherein the activation signal is generated when at least one of the one or more sensors senses a voluntary blink by the user of the ophthalmic device.

9. The ophthalmic device of claim 1, wherein the metal cap forms a hermetic seal over an opening of the one or more containment cells.

10. The ophthalmic device of claim 1, wherein the active agent can include one or more of:

a lubricant, a saline, a solvent, a vitamin, and a medicament.

11. The ophthalmic device of claim 1, wherein a binary shape memory alloy forming part of the metal cap is configured to be under stress after assembly.

12. The ophthalmic device of claim 1, wherein a method used to bond the metal cap to the substrate during assembly provides stress to the bonded metal cap.

13. The ophthalmic device of claim 12, wherein the metal cap comprises one or more of:

gold, titanium, nickel, stainless steel, cobalt-chromium, and nitinol.

14. An active agent dispensing digital microarray device comprising:

a semiconductor material substrate including one or more containment cells, at least one of the one or more containment cells containing an active agent enclosed by a biocompatible metal cap bonded under stress to a surface of the semiconductor material substrate; and

a micro-processor energized by an energy source and in connection with an activation element, the activation element configured to conduct an electrical current to at least a portion of the biocompatible metal cap upon the receipt of an activation signal from the micro-processor, and

wherein the electrical current and the stress are sufficient to cause the biocompatible metal cap to fold and thereby expose the active agent contained in at least one or the one or more containment cells.

15. The active agent dispensing digital microarray of claim 14, wherein the micro-processor is in connection with an antenna, and is configured with the antenna to wirelessly receive one or more signals from a wireless device.

16. The active agent dispensing digital microarray of claim 14, wherein the active agent can include one or more of:

a lubricant, a saline, a solvent, a vitamin, and a medicament.

17. The active agent dispensing digital microarray of claim 14, additionally comprising one or more sensors in connection with the micro-processor,

wherein at least one of the one or more sensors is configured to measure the concentration of one or more biomarkers and provide a signal when the measured concentration is outside a predetermined range.

18. The active agent dispensing digital microarray of claim 14, wherein the active agent dispensing digital microarray forms part of an ophthalmic device.

19. A method of dispensing an active agent comprising:

forming a substrate having one or more containment cells;

depositing one or more active agents into at least one of the one or more containment cells;

forming a hermetic seal over an opening of at least one of the one or more containment cells by bonding a biocompatible metal cap under stress to a surface of the substrate; and

providing an activation element configured to conduct an electrical current from an energy source to at least a portion of the biocompatible metal cap causing the biocompatible metal cap to fold and thereby expose the active agent to a surrounding environment.

20. The method of claim 19, additionally comprising:

providing a micro-processor in connection with an antenna and the energy source; and

receiving, using the antenna, a wireless signal from a wireless device used to generate an activation signal for the energizing of the activation element.

21. The method of claim 19, wherein the active agent can include one or more of:

a lubricant, a saline, a solvent, a vitamin, and a medicament.

22. The method of claim 19 additionally comprising:

encapsulating at least part of the substrate in a hydrogel.

23. The method of claim 19 additionally comprising:

encapsulating the energy source in a media insert configured to be positioned in an ophthalmic device and supporting the substrate and the activation element.

24. The method of claim 19, wherein the energy source is an energy receptor antenna in electrical communication with said activation element.

25. The method of claim 19, additionally comprising:

providing a micro-processor in connection with one or more sensors and the energy source; and

generating an activation signal for energizing the activation element based upon one or more of said sensors detecting a pre-defined parameter.