PATIENT CUSTOMIZED THERAPEUTIC REGIMENS

• US 20090076338A1
• Filed: 05/02/2007
• Published: 03/19/2009
• Est. Priority Date: 05/02/2006
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark J., Thompson, Andrew, Savage, George M.
• Granted Patent: US 8,956,287 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: H01M 2220/10 Batteries in stationary systems, e.g. emergency power source in plant
• CPC Class Codes: H01M 8/02 Details electrodes H01M4/86 - H01M4/98
• CPC Class Codes: H04B 13/005 Transmission systems in which the medium consists of the human body
• CPC Class Codes: Y02E 60/10 Energy storage using batteries
• CPC Class Codes: Y02E 60/50 Fuel cells
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

Methods, systems and compositions that allow for treating a patient according to a patient customized therapeutic regimen are provided. Embodiments of the invention include obtaining dosage administration information from a patient and using the same to tailor a therapeutic regimen for the patient. Embodiments of the invention further include preparing and forwarding to the patient physical pharmaceutical dosages based on the customized therapeutic regimen.

Claims

1. A method of treating a patient for a condition, said method comprising:

(a) obtaining confirmatory data for administration of a medical composition to said patient, wherein;

(i) said patient is on a therapeutic regimen for treatment of said condition; and

(ii) said confirmatory data is produced by a first device and is transmitted to a second device, where both of said first and second devices are associated with the body of said patient;

(b) evaluating said confirmatory data to determine when a change in said therapeutic regimen is desired; and

(c) if the change is determined to be desired, modulating said therapeutic regimen.

2. The method according to claim 1, wherein said confirmatory data is recorded by said second device.

3. The method according to claim 1, wherein said first and second devices are electrically coupled to said body.

4. The method according to claim 1, wherein said confirmatory data is transmitted from said first device to said second device by establishing an electrical current between said first and second devices.

5. The method according to claim 4, wherein said electrical current is confined among said first and second devices and said body.

6. The method according to claim 4, wherein said electrical current is confined among said first and second devices, and wherein said first and second devices are each capacitively coupled to a conductor or ground external to said patient.

7. The method according to claim 1, wherein said confirmatory data is obtained automatically.

8. The method according to claim 1, wherein said first and second devices are different types of devices.

9. The method according to claim 8, wherein said first device comprises an active agent.

10. The method according to claim 9, said second device does not comprise an active agent.

11. The method according to claim 10, wherein said method further comprises transmitting a second set of confirmatory data from a third device to said second device.

12. The method according to claim 11, wherein said third device comprises an active agent

13. The method according to claim 1, wherein said medical composition is selected from the group consisting of a drug, a vitamin, saline, infusate, a dialysate and an antacid.

14. The method according to claim 1, wherein said first device comprises an identifier associated with a pharmaceutical composition, wherein said identifier produces said confirmatory data upon contact with a target physiological site of said patient.

15. The method according to claim 1, wherein said evaluating comprises inputting said data into a decision support tool and obtaining from said decision support tool a recommendation based on said confirmatory data as to whether a change in said therapeutic regimen is desirable.

16. The method according to claim 15, wherein said evaluating further comprises assessing physiological data obtained from said patient.

17. The method according to claim 15, wherein said evaluating further comprises assessing lifestyle information obtained from said patient.

18. The method according to claim 1, wherein said method further comprises forwarding said confirmatory data from said patient to a location distinct from the second device.

19. The method according to claim 18, wherein said location distinct from the second device is a remote location.

20. The method according to claim 15, wherein said method further comprises providing a recommendation to a health care practitioner who reviews said recommendation to determine whether a change in said therapeutic regimen is to be made.

21. The method according to claim 20, wherein in response to said recommendation said health care practitioner modulates said therapeutic regimen and communicates a modulated therapeutic regimen to said patient.

22. The method according to claim 21, wherein said modulated therapeutic regimen includes a change in a pharmaceutical dosage regimen.

23. The method according to claim 22, wherein said change in said pharmaceutical dosage regimen includes a change in an amount of a pharmaceutical agent.

24. The method according to claim 22, wherein said change in said pharmaceutical dosage regimen includes a change in at least one type of pharmaceutical agent administered to said patient.

25. The method according to claim 20, wherein said method further comprises preparing a physical pharmaceutical dosage comprising one or more active agents and forwarding said physical pharmaceutical dosage to said patient.

26. The method according to claim 25, wherein said physical pharmaceutical dosage comprises two or more distinct compositions.

27. The method according to claims 25, wherein said physical pharmaceutical dosage comprises a composition that includes two or more active agents.

28. The method according to claim 27, wherein said composition is fabricated in response to said modulation of said therapeutic regimen.

29. The method according to claim 25, wherein said composition(s) of said physical pharmaceutical dosage comprises a dosage administration compliance identifier.

30. A system for treating a patient for a condition, said system comprising:

(a) an input manager for receiving confirmatory data for administration of a medical composition to a patient;

(b) a processing module comprising a therapeutic regimen evaluator configured to assess a therapeutic regimen based on received confirmatory data to determine whether a change in a therapeutic regimen is desirable and provide a recommendation based on said determination; and

(c) an output manager for providing said recommendation to a user.

31. A method of treating a patient for a condition, said method comprising:

inputting confirmatory data received from said patient into a system according to claim 30; and

obtaining a recommendation from said system and treating said patient according to said recommendation.

32. (canceled)

33. A method in the form of a computer readable medium embodying a set of instructions that, when executed by a processor, causes the processor to perform the method of:

(a) receiving confirmatory data for administration of a medical composition to a patient;

(b) assessing a therapeutic regimen of said patient in view of said confirmatory data to determine whether a change in a therapeutic regimen is desirable and providing a recommendation based on the determination; and

(c) providing the recommendation to a user.

34. A system comprising:

a first device configured to produce confirmatory data for administration of a medical composition to a patient and transmit said confirmatory data to a second device;

a second device configured to receive said confirmatory data from said first device; and

a wireless communication device configured to receive said confirmatory data from said second device and to relay said received confirmatory data to a remote location.

35. The system according to claim 34, wherein said system further includes a device to process said confirmatory data and provide a recommendation to a user.

36. The system according to claim 34, wherein said first and second devices are configured to be associated with the body of a patient.

37. The system according to claim 34, wherein said first device comprises an active agent.

38. The system according to claim 34, wherein said remote location comprises a database.