SYSTEMS AND METHODS FOR USING PHYSIOLOGICAL INFORMATION

• US 20120064006A1
• Filed: 08/08/2011
• Published: 03/15/2012
• Est. Priority Date: 08/06/2010
• Status: Abandoned Application

• Current Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Original Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Inventors: YADAV, JAY
• Application Number:
  US13/205,459
• Publication Number:
  US 20120064006A1
• Time in Patent Office: Days
• US Class Current: 424/9.2
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: G06F 16/245 Query processing
• CPC Class Codes: G16C 20/50 Molecular design, e.g. of drugs
• CPC Class Codes: G16C 20/90 Programming languages; Computing architectures; Database systems; Data warehousing
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

Systems and methods using a database of physiological information for the design, development, testing and use of therapeutics. In one aspect, the physiological information can include at least one of: hemodynamic monitoring information, pulmonary arterial pressure, cardiac output, heart rate, respiratory rate, peripheral vascular resistance, total peripheral resistance or dicrotic notch information. Optionally, the cardiovascular physiology information can include ambulatory physiological information.

Claims

1. A process comprising:

developing a therapeutic using a database of physiological information, wherein the physiological information comprises cardiovascular physiology information, and wherein the cardiovascular physiology information comprises at least one of;

hemodynamic monitoring information, pulmonary arterial pressure, cardiac output, peripheral vascular resistance, total peripheral resistance, heart rate, respiratory rate, and dicrotic notch information.

9. The process of claim 1, wherein developing further comprises prospectively guiding development of the therapeutic using the database of physiological information.

10. The process of claim 9, wherein prospectively guiding development of the therapeutic comprises designing the therapeutic.

11. The process of claim 10, wherein prospectively guiding development of the therapeutic further comprises designing a testing protocol for the therapeutic.

12. The process of claim 10, wherein prospectively guiding development of the therapeutic further comprises identifying patients for clinical trials.

13. The process of claim 10, wherein prospectively guiding comprises modeling predicted characteristics of the therapeutic.

14. The process of claim 13, wherein the predicted characteristics comprise at least one of:

efficacy, drug-drug interaction, safety, adverse events, and dosing.

15. The process of claim 1, wherein developing the therapeutic using the database further comprises using the database to meet regulatory requirements and providing access to the physiological information on the database to a regulatory authority.

2. The process of claim 2, wherein the cardiovascular physiology information is remotely obtained.

3. The process of claim 2, wherein the cardiovascular physiology information comprises ambulatory cardiovascular information.

4. The process of claim 3, wherein the cardiovascular physiology information is obtained wirelessly.

5. The process of claim 4, wherein the cardiovascular information is obtained from an implanted sensor.

6. The process of claim 5, wherein the implanted sensor is a pressure sensor.

7. The process of claim 6, wherein the pressure sensor is implanted in a pulmonary artery.

8. The process of claim 5, wherein the sensor is a passive sensor configured to be energized by an electromagnetic field produced from an external source.

16. A computer system comprising a memory on which is stored:

a database including high-fidelity physiological information obtained from a plurality of patients and correlated with a plurality of associated conditions;

instructions for receiving from a user an inquiry about a therapeutic;

instructions for determining a relationship between the therapeutic and one of the associated conditions or the high-fidelity physiological information.

17. The computer system of claim 16, wherein the high-fidelity physiological information is obtained from an implanted sensor.

18. The computer system of claim 17, wherein the associated conditions are ambulatory conditions.

19. The computer system of claim 18, further comprising instructions for receiving a date stamp associated with the high-fidelity physiological information and with the ambulatory conditions and instructions for correlating the date stamps to develop associative information characterizing temporal relationships between the high-fidelity physiological information and the ambulatory conditions and store the associative information on the database.

20. The computer system of claim 18, wherein the inquiry about the therapeutic is a design inquiry configured to prospectively predict success of the therapeutic based on a predicted physiological impact of the therapeutic and the high-fidelity physiological information.

21. A method for assessing an effect of a therapeutic agent on a hemodynamic parameter of a subject, comprising:

providing at least one database including hemodynamic data comprising a plurality of hemodynamic values measured in one or more subjects having been administered a therapeutic agent; and

identifying a change in one or more of the measured hemodynamic values resulting from the administration of the therapeutic agent, the change indicating an effect of the therapeutic agent on the hemodynamic parameter of the subject.

22. The method of claim 21, wherein the hemodynamic data comprises at least one hemodynamic value measured in a subject prior to administration of the therapeutic agent.

23. The method of claim 21, wherein the hemodynamic data comprises at least one hemodynamic value measured in a subject concurrent with administration of the therapeutic agent.

24. The method of claim 21, wherein the hemodynamic data comprises at least one hemodynamic value measured in a subject subsequent to administration of the therapeutic agent.

25. The method of claim 21, wherein the hemodynamic data comprises at least one hemodynamic value measured in a subject prior to administration of the therapeutic agent and at least one hemodynamic value measured in a subject subsequent to administration of the therapeutic agent.

26. The method of claim 21, wherein one or more additional therapeutic agents are administered to the subject prior to, concurrently with, or subsequent to the therapeutic agent.

27. The method of claim 21, further comprising modifying the therapeutic agent to selectively increase or decrease the indicated effect.

28. The method of claim 21, further comprising modifying an administration characteristic of the therapeutic agent to selectively increase or decrease the indicated effect, wherein the administration characteristic is selected from the group consisting of:

dosage amount, number of doses, timing of doses, route of administration, and total dosage.

29. The method of claim 21, further comprising determining one or more portions of the therapeutic agent responsible for the indicated effect.

30. The method of claim 29, further comprising designing a second therapeutic agent including the one or more portions of the therapeutic agent responsible for the indicated effect.

31. The method of claim 29, further comprising designing a second therapeutic agent wherein the one or more portions of the therapeutic agent responsible for the indicated effect are removed or reduced in effect.

32. The method of claim 21, wherein the indicated effect is used to assess safety of the therapeutic agent for administration to a mammal or population thereof.

33. The method of claim 21, wherein the indicated effect is used to assess the toxicity of the therapeutic agent for administration to a mammal or population thereof.

34. The method of claim 21, wherein the indicated effect is used to assess the efficacy of the therapeutic agent for administration to a mammal or population thereof.

35. The method of claim 21, wherein the indicated effect is used to predict the effect or effects of the therapeutic agent or agents having the same or similar pharmacological characteristics on the hemodynamic parameter.

36. The method of claim 21, wherein the indicated effect is used to predict the effect or effects of the therapeutic agent or agents having the same or similar pharmacological characteristics on a hemodynamic parameter of a mammal.

37. The method of claim 21, wherein the indicated effect is used to determine an end point for a clinical trial.

38. The method of claim 21, further comprising determining one or more characteristic of the subject, wherein the characteristic is selected from the group consisting of:

a physical, physiologic, metabolic, chronological, disease state, drug administration history, medical history, and genetic characteristic.

39. The method of claim 38, wherein the characteristic is correlated with the indicated effect in the subject.

40. The method of claim 39, wherein the correlation of the characteristic and the indicated effect in the subject is used to select one or more additional subjects for administration of the therapeutic agent or for a therapeutic agent having the same or similar indicated effect.

41. The method of claim 39, wherein the correlation of the characteristic and the indicated effect is used to select one or more additional subjects to participate in a clinical trial for the therapeutic agent or for a therapeutic agent having the same or similar indicated effect.

42. The method of claim 39, wherein the correlation of the characteristic and the indicated effect in the subject is used to select or modify a therapeutic regimen in the subject or in another subject having the same or similar characteristics, wherein the selecting or modifying comprises selecting or modifying drug administration protocol including dosage of one or more therapeutic agent, selection of one or more therapeutic agent, combination of therapeutic agents, or timing of administration of one or more therapeutic agent.

43. The method of claim 21, further comprising using the indicated effect to alter the treatment protocol of the subject, wherein the alteration is selected from the group consisting of:

administering less of the therapeutic agent, administering more of the therapeutic agent, discontinuing use of the therapeutic agent, administering one or more additional agents, and the timing of administration of the agent.

44. The method of claim 21, wherein the hemodynamic parameters are selected from the group consisting of heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, stroke volume, cardiac output, peripheral vascular resistance, total peripheral resistance and pulmonary arterial pressure.

45. The method of claim 44, wherein the hemodynamic values measured in the subject are measured using an implantable sensor device.

46. The method of claim 45, wherein the implantable sensor device measures pulmonary arterial pressure and is implanted in the pulmonary artery, and wherein the implantable sensor communicates measurements of pulmonary arterial pressure remotely wirelessly.

47. A method for predicting an effect of a candidate therapeutic agent on a hemodynamic parameter of a patient, comprising:

providing at least one database including hemodynamic data comprising a plurality of hemodynamic values measured in one or more patients;

identifying a candidate therapeutic agent for administration to the one or more patients; and

correlating all or a subset of the hemodynamic data with the candidate therapeutic agent to indicate a predicted change in one or more hemodynamic values in the one or more patients that would result from administration of the candidate agent, the predicted change indicating the predicted effect of the candidate agent on the hemodynamic parameter of the one or more patients,

administering a therapeutic agent to the one or more patients, wherein the therapeutic agent administered to the one or more patients is of the same class as the candidate agent.

48. A method for designing a therapeutic agent, comprising:

determining a change to a hemodynamic parameter of a subject or an expected change resulting from administration of the therapeutic agent, and

using the change or expected change in the hemodynamic parameter to design a therapeutic agent,

wherein the change or expected change is desirable and the therapeutic agent is modified to increase the magnitude, onset or duration of the change or wherein the change or expected change is undesirable and the therapeutic agent is modified to decrease the magnitude, onset or duration of the change.

49. A method of identifying a subject based on a specified hemodynamic response to a therapeutic agent, comprising:

determining characteristics of the subject that indicate an increased likelihood that the subject will have the specified hemodynamic responses; and

selecting the identified subject or a plurality of subjects having the same or similar determining characteristics to participate in a clinical study for the therapeutic agent.

50. A method of developing a therapeutic agent or regimen for administering the therapeutic agent, comprising:

determining a change to a hemodynamic parameter of a subject or an expected change resulting from administration of the therapeutic agent; and

using the change or expected change in the hemodynamic parameter to develop the therapeutic agent or regimen.

51. A method for assessing the efficacy of a therapeutic agent, comprising:

determining a change to a hemodynamic parameter of a subject or an expected change resulting from administration of the therapeutic agent; and

using the change or expected change in the hemodynamic parameter to assess the efficacy of the therapeutic agent.