Optimized bio-synchronous bioactive agent delivery system

• US 10,105,487 B2
• Filed: 01/16/2014
• Issued: 10/23/2018
• Est. Priority Date: 01/24/2013
• Status: Active Grant

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: DiPierro, Guy, Levy, Alan Joel
• Primary Examiner(s): Eisenberg, R.
• Application Number:
  US14/156,998
• Publication Number:
  US 20140207048A1
• Time in Patent Office: 1,741 Days
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 25/34 Tobacco-abuse
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

Optimized bio-synchronous drug delivery begins with establishing a bio-synchronous treatment protocol that incorporates individual temporal and innate biological characteristics into a pharmacological treatment plan. The bio-synchronous treatment protocol is thereafter initiated using bioactive agent delivery device. Bio-synchronous drug delivery includes continual collection of patient data such as physical, psychological, temporal and environmental characteristics. This data is analyzed so to not only determine an initial treatment protocol but to also determining whether modification to the ongoing bio-synchronous treatment protocol is required. And, responsive to determining a modification is required the system modifies the bio-synchronous treatment protocol and use of delivery device. These modifications and treatment protocols can include reactive and proactive psychological support supplied to the patient in a variety of formats.

Claims

1. A method for delivering a drug to a patient according to a bio-synchronous drug delivery protocol, the method comprising:

initiating the bio-synchronous drug delivery protocol wherein the bio-synchronous drug delivery protocol includes use of a bio-synchronous bioactive agent delivery device to administer a dose of the drug to the patient;

gathering patient data with the bio-synchronous bioactive agent delivery device during the bio-synchronous drug delivery protocol; and

obtaining a psychological support based on the patient data.

2. The method for optimized bio-synchronous drug delivery according to claim 1, wherein the at least one bioactive agent is chosen from the group consisting of alprazolam, apomorphine, azelastine, buprenorphine, bupropion, clonidine, enalpril, estradiol, ethinyl estradiol, fentanyl, granisetron, insulin, lidocaine, memantine, methylphenidate, methamphetamine, nitroglycerine, nicotine, norethisterone acetate (NETA), norelgestromine, oxybutynin, pergolide, phenteramine, pramipexole, ramipril, ropinirole, rotigotine, scopolamine, selegiline, tecrine, testosterone, timolol and tolterodine.

3. The method of claim 1, wherein patient data includes patient emotional state data.

4. The method of claim 3, wherein patient emotional state data includes cravings.

5. The method of claim 3, wherein patient emotional state data includes anxiety.

6. The method of claim 1, further comprising:

receiving an indication of a craving input to a smart phone, tablet, or computer by the patient.

7. The method of claim 1, wherein patient data includes patient physiological data.

8. The method of claim 7, wherein the patient physiological data is gathered using physiological sensors on the bio-synchronous bioactive agent delivery device.

9. The method of claim 1, wherein the psychological support includes emotional support.

10. The method of claim 9, further comprising:

providing the emotional support.

11. The method of claim 10, wherein emotional support is provided after receiving an indication from the patient of a need for treatment.

12. The method of claim 10, wherein the emotional support is provided by a text message, supportive tip, vibrating tone, e-mail, call, or voicemail message.

13. The method of claim 1, further comprising:

determining based on gathered patient data whether modification to the bio-synchronous drug delivery protocol is required; and

responsive to determining modification to the bio-synchronous drug delivery protocol is required, modifying the bio-synchronous drug delivery protocol and use of the bio-synchronous bioactive agent delivery device.

14. The method of claim 13, wherein modifying includes remotely adjusting the bio-synchronous treatment protocol.

15. The method of claim 14, further comprising:

a healthcare provider remotely adjusting the bio-synchronous treatment protocol.

16. The method of claim 15, wherein remotely adjusting includes delivering the bioactive agent and/or providing emotional support.

17. The method of claim 1, wherein patient data includes compliance with the bio-synchronous drug delivery protocol.

18. The method of claim 1, further comprising:

determining patient compliance with the bio-synchronous drug delivery protocol.

19. The method of claim 18, further comprising:

analyzing patient compliance during the bio-synchronous drug delivery protocol.

20. The method of claim 19, wherein analyzing patient compliance includes determining bio-synchronous bioactive agent delivery device contact with a skin of the patient.

21. The method of claim 19, wherein analyzing patient compliance includes one or more of determining whether the bio-synchronous bioactive agent delivery device was removed, a treatment in the bio-synchronous drug delivery protocol was missed, or if the bio-synchronous drug delivery protocol was interrupted.

22. The method of claim 19, further comprising upon determination of a non-compliant event:

sending an automated message to encourage the patient or sending a message to a healthcare provider.

23. The method of claim 19, wherein patient compliance includes:

time of administration of the bioactive agent, a dosage amount of the bioactive agent, and a time at which dosing ceased.

24. The method of claim 1, further comprising:

receiving patient data on a smart phone application.

25. The method of claim 1, further comprising:

the drug delivery device transmitting patient data wirelessly to a smartphone, tablet, or computer.

26. The method of claim 1, further comprising:

the drug delivery device transmitting patient data to a wireless network.

27. The method of claim 1, wherein the bio-synchronous drug delivery protocol includes a psychological support program.

28. The method of claim 1, further comprising:

modifying the bio-synchronous drug delivery protocol and use of the bio-synchronous bioactive agent delivery device in response to a determination of a non-compliant event or receiving an indication of a craving input.