Rheological treatment methods and related apheresis systems

• US 20030127390A1
• Filed: 12/12/2002
• Published: 07/10/2003
• Est. Priority Date: 12/29/1998
• Status: Abandoned Application

• Current Assignee: Tearlab Corp.
• Original Assignee: OccuLogix Corporation
• Inventors: Davis, Richard C. Jr.
• Application Number:
  US10/316,895
• Publication Number:
  US 20030127390A1
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/84 for treating several patients simultaneously
• 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 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

Therapeutic apheresis treatments and diagnostic monitoring methods are described, specifically relating to the depletion and/or removal of a broad bandwidth of certain rheologically active elements from the blood of a patient followed by return of the blood so treated to the patient, and to methods or procedures of apheresis treatment, especially biophysiologic blood filtering treatments and computer medicated delivery methods configured to provide such apheresis treatments to patients with certain chronic, age-related, degenerative, atherogenic, thrombotic or inflammatory diseases; especially those associated with RAM accumulation-deposition causing disturbances of blood rheology or microcirculatory impairment.

Claims

1. A therapeutic method comprising the step of depleting at least two species of rheologically active macromolecules from a patient'"'"'s plasma;

wherein the macromolecules are depleted for a period of time and to a level that is effective to produce an improvement in a measurable endpoint or clinical improvement in a disease associated with elevated levels of rheologically active macromolecules.

2. The method of claim 1, wherein the depleted rheologically active macromolecules are selected from the group consisting of cholesterol isoforms (VLDL, LDL and IDL), triglycerides, fibrinogen, alpha-2 macroglobulin tetramers, IgM, Lipoprotein A, fibronectin, vitronectin, and IgA.

7. The method of any of claims 1-6, wherein the depleting step is accomplished by Rheopheresis®

blood filtration.

8. The method of claim 7, wherein the volume of plasma processed through Rheopheresis®

blood filtration in a single treatment session ranges between about 80% and 120% of the patient'"'"'s total plasma volume.

9. The method of claim 7, wherein the time interval between successive Rheopheresis®

blood filtration treatments in a dual session ranges from about one day to about ten days and the total plasma volume processed in any one week period is at least about 200% of a patient'"'"'s total plasma volume and, optionally, the successive treatment interval prior to the next dual session preferably is about 16 days ±

about 3 days.

10. The method of claim 7, wherein the Rheopheresis®

blood filtration is effective to produce in the patient a response selected from the group consisting of;

(1) increased microperfusion or capillary function;

(2) improved immune response; and

(3) extraction of tissue-bound RAM and to deplete the extracted RAM from the patient'"'"'s plasma.

11. The method of claim 7, wherein the Rheopheresis®

blood filtration is effective to produce in the patient a clinically observable improvement in a disorder characterized by elevated plasma levels of rheologically active macromolecules.

12. The method of claim 11, wherein the disorder is selected from the group consisting of:

(1) age-related macular degeneration;

(2) atherosclerosis;

(3) rheumatoid arthritis;

(4) autoimmune diseases;

(5) Diabetes;

(6) Alzheimer'"'"'s disease;

(7) Procoagulant states, and (8) neurodegenerative diseases.

3. A therapeutic method comprising the step of depleting from a patient'"'"'s plasma the high molecular weight fraction of plasma constituents;

wherein the high molecular weight fraction of plasma constituents are depleted for a period of time and to a level that is effective to produce an improvement in a measurable endpoint or clinically observable improvement in a disease associated with elevated levels of rheologically active macromolecules in the high molecular weight fraction of plasma constituents.

4. The method of claim 3, wherein the depleted plasma constituents have a molecular weight greater than about 500,000 Daltons.

5. The method of claim 3, wherein the depleted plasma constituents have an average size of the biologically active isoform is greater than about 200 Å

across the shortest diameter.

6. The method of claim 3, wherein the depleted components are depleted to a level of at least about 50% of their levels in the patient compared to that prior to treatment.

13. A Rheopheresis®

blood filtration filter packaged together with a label or package insert indicating its use for treatment of an age-related, degenerative, atherogenic, thrombotic or inflammatory disorder characterized by elevated plasma levels of rheologically active macromolecules.

14. The filter and label or package insert according to claim 13, wherein the disorder is selected from the group consisting of:

(1) age-related macular degeneration;

(2) atherosclerosis;

(3) rheumatoid arthritis;

(4) autoimmune diseases;

(5) Diabetes;

(6) Alzheimer'"'"'s disease;

(7) Procoagulant states, and (8) neurodegenerative diseases.

15. A diagnostic method comprising the step of measuring the absolute or relative levels of at least two rheologically active macromolecules depleted from a patient'"'"'s plasma by Rheopheresis®

blood filtration.

16. The diagnostic method of claim 15, comprising the further step of assessing the plasma levels or rate of decrease of such levels post treatment, then making an assessment of the concomitant increase of the plasma levels of the depleted rheologically active macromolecules as they re-equilibrate toward pre-treatment levels.

17. A method of providing Rheopheresis®

blood filtration treatment, comprising the steps of

(a) evaluating a candidate patient to identify whether the patient has a RAM associated disease and to determine that state and extent of that disease;

(b) determining whether the patient exhibits elevated plasma levels of at least two RAMs;

(c) declining to treat patients with Rheopheresis®

blood filtration who are not likely to respond to treatment or who might be harmed by the treatment;

(d) selecting a particular Rheopheresis®

blood filtration treatment protocol appropriate for chronic versus acute medical situations; and

(e) providing Rheopheresis®

blood filtration treatment.

18. The method of claim 17, wherein the step of selecting a particular Rheopheresis®

blood filtration treatment protocol includes an evaluation of a data base containing data on other patients treated by Rheopheresis®

blood filtration.

19. The method of claim 17, further comprising the step of providing disease-specific medical follow-up evaluations.

20. The method of claim 19, further comprising the step of submitting data on the patient to a data base containing data on other patients treated by Rheopheresis®

blood filtration.

21. An integrated apheresis treatment process comprising the steps of:

(a) providing at least one dedicated out-patient, non-hospital, apheresis treatment facility;

(b) locating and selecting ambulatory, community-dwelling patients potentially capable of benefiting from apheresis treatments within a community that can be served by said apheresis facility;

(c) identifying and selecting from among said patients, by-means which include measurement of serum levels of circulating rheologically active macromolecules in said patients, a subset of patients capable of benefiting from apheresis treatments;

(d) performing apheresis treatments in sessions on the selected patients in said dedicated out-patient apheresis treatment facility; and

(e) determining clinical endpoints to said apheresis treatments based upon reductions in serum levels of said rheologically active macromolecules and correlations of clinical symptomatology through disease-specific testing and serial endpoint and clinical assessments.

22. An apheresis treatment method, comprising the steps of:

(a) identifying chronically ill patients having age-related, degenerative, atherogenic, thrombotic or inflammatory diseases, said chronically ill patients being considered candidates for an apheresis procedure;

(b) storing patient profile data for an identified chronically ill patient;

(c) analyzing qualifying data for said identified chronically ill patient to determine applicability of an apheresis treatment; and

(d) performing apheresis treatments in sessions on said identified chronically ill patient.

23. The method of claim 22, wherein step (b) further comprises the step of storing at least one of medical history data, physical characteristic data, medical condition data, diagnosis data, historical procedure data, and clinical effect data.

24. The method of claim 22, wherein step (c) further comprises the step of analyzing at least one of medical history data, disease specific history data, physical examination data, and interview data.

25. The method of claim 22, wherein step (c) further comprises the step of comparing patient profile data with a composite patient profile that is generated using data from similar patients who have completed an apheresis treatment process.

26. The method of claim 25, wherein step (c) further comprises the step of determining at least one of a probability of apheresis treatment success, a potential degree of anticipated clinical outcomes based upon statistical normograms from an analysis of historical composite patient profiles, and a most appropriate initial apheresis treatment protocol.

27. An apheresis treatment qualification method, comprising the steps of:

(a) identifying a chronically ill patient having an age-related, degenerative, atherogenic, thrombotic or inflammatory disease, said chronically ill patient being considered a candidate for an apheresis procedure;

(b) storing patient profile data for said identified chronically ill patient;

(c) receiving, from a centralized database system, a composite patient profile derived from other patients similarly situated to said identified chronically ill patient;

(d) comparing said patient profile data with said received composite patient profile; and

(e) determining based upon the comparison in step (d), whether said identified chronically ill patient would likely benefit from apheresis treatments.

28. The method of claim 27, wherein step (b) comprises the step of storing at least one of medical history data, physical characteristic data, medical condition data, diagnosis data, historical procedure data, and clinical effect data.

29. A method of screening patients for a Rheopheresis®

blood filtration treatment comprising the steps of;

(a) identifying whether the patient has a RAM associated disease and determining that state and extent of that disease;

(b) determining whether the patient exhibits elevated plasma levels of at least two RAMs;

(c) selecting patients who are likely to respond to Rheopheresis®

blood filtration treatment or who will not be harmed by the treatment; and

, optionally,

(d) selecting a particular Rheopheresis®

blood filtration treatment appropriate for treating a specific RAM associated disease.

30. The method of claim 29, wherein the step of selecting a particular Rheopheresis®

blood filtration treatment further includes screening a data base containing patient data from individuals treated by Rheopheresis®

blood filtration to determine the most appropriate treatment protocol.

31. The method of claim 29, further comprising the step of submitting data in a patient profile to a data base containing patient data from other Rheopheresis®

blood filtration treatment patients.

32. A treatment protocol generator for use in a system that endeavors to generate disease specific treatment protocols based on a patient profile, said treatment protocol generator comprising:

(a) a treatment protocol derivation means for analyzing disease specific historical composite patient profiles to derive treatment protocols having enhanced therapeutic effects;

(b) an identifying means for identifying particular data of a patient profile which will serve to optimize the disease specific apheresis treatment; and

(c) a treatment protocol generating means for generating treatment protocol that, when executed, will enable optimization of the therapeutic effect of apheresis treatment.

33. The treatment protocol generator of claim 32, further comprising:

(a) a comparing means for comparing said data of said patient profile against a prescribed set of data to identify any of said treatment protocols substantially conforming to desired therapeutic result; and

(b) classifying means for classifying said identified suitable treatment protocols in order of suitability based on said patient profile.

34. The treatment protocol generator of claim 32, wherein said identifying means comprises means for identifying, in accordance with said composite historical patient profiles, data from said database that will result a treatment protocol predicted to have a superior therapeutic effect;

and wherein said data includes at least one of medical history data, physical characteristic data, medical condition data, diagnosis data, historical procedure data, clinical effect data, disease specific history data, physical examination data, and interview data.

35. The treatment protocol generator of claim 32, wherein said treatment protocol generator further comprises optimal set selecting means for selecting an optimal set of treatment parameters based on at least one of the following factors:

(i) their respective predicted abilities to exhibit therapeutic results more closely matching said prescribed set of therapeutic results as indicated by said composite historical patient profiles;

(ii) their respective predicted abilities to validate said composite historical patient profiles;

(iii) their respective predicted abilities to discriminate between said composite historical patient profiles;

(iv) their respective predicted abilities to induce superior therapeutic response; and

(v) similarity between their disease specific characteristics and those in composite historical patient profile database whose therapeutic response most closely conform to the desired therapeutic response.

36. The treatment protocol generator of claim 35, wherein said optimal set selecting means comprises means for selecting said optimal set by individually ranking said treatment parameters based on at least one of factors (i)-(v).

37. The treatment protocol generator of claim 35, wherein said optimal set selecting means comprises means for selecting said optimal set by ranking combinations of said treatment parameters based on at least one of factors (i)-(v).

38. An apheresis treatment data collection and treatment system, comprising:

(a) a plurality of interconnected computer systems located at a respective plurality of apheresis treatment sites, said plurality of interconnected computer systems being configured to receive input reflective of apheresis treatment parameters and clinical effects produced by apheresis treatments, wherein at least one of said plurality of interconnected computer systems is located at a dedicated out-patient apheresis treatment facility; and

(b) a centralized database system including a storage facility that stores apheresis treatment parameter data and clinical effects data that are received from said plurality of interconnected computer systems, said centralized database system further including a means for creating a composite patient profile based upon apheresis treatment data that is collected for patients treated at said plurality of apheresis treatment sites.

39. The system of claim 38, wherein said plurality of interconnected computer systems and said centralized database system are interconnected to form a computer network.

40. The system of claim 39, wherein said computer network is connected to the Internet.

41. The system of claim 40, wherein said computer network utilizes a computerized data management system for coordinating, managing, directing, entering, accessing, and analyzing all aspect of medical subspecialty-directed, disease-specific apheresis services throughout said computer network, said data management system comprising:

(a) at least one processing unit for processing data in said data management system;

(b) at least one storage device for storing information in said data management system; and

(c) a software component for managing and controlling said processing unit and said storage device.

42. The system of claim 41, wherein said data management system further comprises:

(a) means for tracking apheresis patients;

(b) means for providing real-time paperless data entry of apheresis treatment parameters during apheresis procedures at said plurality of apheresis treatment facilities;

(c) means for providing central access for real-time remote monitoring, via a secure Internet link, of all steps in said apheresis treatment process at said plurality of apheresis treatment facilities; and

(d) means for allowing all authorized members of said computer network to enter patient data and retrieve reports and analysis based on all prior patients treated.

43. The system of claim 42, wherein said data management system is located in one of said plurality of apheresis treatment facilities.

44. The system of claim 42, wherein said data management system is centralized in a dedicated facility for ease of maintenance and overall system management.

45. The system of claim 41, wherein a software unit in each of said plurality of interconnected computer systems is expandable to include, among other information, information about additional diseases.

46. The system of claim 41, wherein upon receiving patient data through said apheresis treatment data collection and treatment system, said software component initializes and indexes said patient data and saves it in at least one of said storage devices in the form of composite patient profiles.

47. The system of claim 46, wherein said software component uses said processing unit to:

(a) process and analyze data in said patient profiles for all patients previously treated by said medical subspecialty-directed, disease-specific apheresis providers within said plurality of apheresis treatment facilities; and

(b) create patient profiles for patients currently undergoing treatment, and to save created profiles in at least one of said storage devices.

48. A method for storing and processing input reflective of apheresis treatment parameters and clinical effects produced by apheresis treatments in a apheresis treatment data collection and treatment system, said method comprising the steps of:

(a) configuring-a plurality of interconnected computer systems located at a respective plurality of apheresis treatment sites to receive input reflective of apheresis treatment parameters and clinical effects produced by apheresis treatments, wherein at least one of said plurality of interconnected computer systems is located at a dedicated out-patient apheresis treatment facility; and

(b) storing apheresis treatment parameter data and clinical effects data that are received from said plurality of interconnected computer systems in a centralized database system, said centralized database system further including a means for creating a composite patient profile based upon adheresis treatment data that is collected for patients treated at said plurality of apheresis treatment sites.

49. The method of claim 48, further comprising the step of interconnecting said plurality of interconnected computer systems and said centralized database system to form a computer network.

50. The method of claim 49, further comprising the step of connecting said computer network is to the Internet.

51. The method of claim 50, further comprising the step of utilizing, by said computer network, a computerized data management system for coordinating, managing, directing, entering, accessing, and analyzing all aspect of medical subspecialty-directed, disease-specific apheresis services throughout said computer network, the method further comprises the steps of:

(a) processing data in at least one processing unit in said data management system;

(b) storing information in at least one storage device in said data management system; and

(c) managing and controlling said processing unit and said storage device by a software component in said data management system.

52. The method of claim 51, wherein the step of managing and controlling further comprises the steps of:

(a) tracking apheresis patients;

(b) providing real-time paperless data entry of apheresis treatment parameters during apheresis procedures at said plurality of apheresis treatment facilities;

(c) providing central access for real-time remote monitoring, via a secure Internet link, of all steps in said apheresis treatment process at said plurality of apheresis treatment facilities; and

(d) allowing all authorized members of said computer network to enter patient data and retrieve reports and analysis based on all prior patients treated.

53. The method of claim 52, further comprising the step of locating said data management system in one of said plurality of apheresis treatment facilities.

54. The method of claim 52, further comprising the step of centralizing said data management system in a dedicated facility for ease of maintenance and overall system management.

55. The method of claim 51, further comprising the step of expanding a software unit in each of said plurality of interconnected computer systems to include, among other information, information about additional diseases.

56. The method of claim 51, further comprising the steps of:

(a) initializing and indexing, by said software component, patient data, upon receiving said patient data through said apheresis treatment data collection and treatment system; and

(b) saving, by said software component, said patient data in at least one of said storage devices in the form of composite patient profiles.

57. The method of claim 56, further comprising the step of using, by said software component, said processing unit to:

(a) process and analyze data in said patient profiles for all patients previously treated by said medical subspecialty-directed, disease-specific apheresis providers within said plurality of apheresis treatment facilities; and

(b) create patient profiles for patients currently undergoing treatment, and save created profiles in at least one of said storage devices.

58. A system for storing and processing input reflective of apheresis treatment parameters and clinical effects produced by apheresis treatments in a apheresis treatment data collection and treatment system, said system comprising:

(a) means for configuring a plurality of interconnected computer systems located at a respective plurality of apheresis treatment sites to receive input reflective of apheresis treatment parameters and clinical effects produced by apheresis treatments, wherein at least one of said plurality of interconnected computer systems is located at a dedicated out-patient apheresis treatment facility; and

(b) means for storing apheresis treatment parameter data and clinical effects data that are received from said plurality of interconnected computer systems in a centralized database system, said centralized database system further including a means for creating a composite patient profile based upon apheresis treatment data that is collected for patients treated at said plurality of apheresis treatment sites.

59. The system of claim 58, further comprising means for interconnecting said plurality of interconnected computer systems and said centralized database system to form a computer network.

60. The system of claim 59, further comprising means for connecting said computer network is to the Internet.

61. The system of claim 60, further comprising means for utilizing, by said computer network, a computerized data management system for coordinating, managing, directing, entering, accessing, and analyzing all aspect of medical subspecialty-directed, disease-specific apheresis services throughout said computer network, the system further comprises:

(a) means for processing data in at least one processing unit in said data management system;

(b) means for storing information in at least one storage device in said data management system; and

(c) means for managing and controlling said processing unit and said storage device by a software component in said data management system.

62. The system of claim 61, wherein said means for managing and controlling further comprises:

(a) means for tracking apheresis patients;

(b) means for providing real-time paperless data entry of apheresis treatment parameters during apheresis procedures at said plurality of apheresis treatment facilities;

(c) means for providing central access for real-time remote monitoring, via a secure Internet link, of all steps in said apheresis treatment process in said plurality of apheresis treatment facilities; and

(d) means for allowing all authorized members of said computer network to enter patient data and retrieve reports and analysis based on all prior patients treated.

63. The system of claim 62, further comprising means for locating said data management system in one of said plurality of apheresis treatment facilities.

64. The system of claim 62, further comprising means for centralizing said data management system in a dedicated facility for ease of maintenance and overall system management.

65. The system of claim 61, further comprising means for expanding a software unit in each of said plurality of interconnected computer systems to include, among other information, information about additional diseases.

66. The system of claim 61, further comprising:

(a) means for initializing and indexing, by said software component, patient data, upon receiving said patient data through said apheresis treatment data collection and treatment system; and

(b) means for saving, by said software component, said patient data in at least one of said storage devices in the form of composite patient profiles.

67. The system of claim 66, further comprising means for using, by said software component, said processing unit to:

(a) process and analyze data in said patient profiles for all patients previously treated by said medical subspecialty-directed, disease-specific apheresis providers within said plurality of apheresis treatment facilities; and

(b) create patient profiles for patients currently undergoing treatment, and save created profiles in at least one of said storage devices.

68. An apheresis treatment data collection and treatment system, comprising:

(a) first means for enabling a user to enter information about a patient in a computer database;

(b) second means for creating a summary of the information entered into the local computer database;

(c) third means for periodically transmitting the summarized information to a data management system database;

(d) fourth means for allowing local users to search the data management system database for a specific patient profile;

(e) fifth means for performing data aggregation and analysis on the data management system database and for producing reports based on a search criterion; and

(f) sixth means for allowing the local users to download the produced reports.

69. The system of claim 68, wherein the sixth means for allowing enables licensed users to establish the efficacy of RheoTherapy®

.

70. The system of claim 69, wherein the first means for allowing enables licensed users to input data for each patient on several transaction forms, the transaction forms are accessed from a main switchboard in the data processing system.

71. The system of claim 70, wherein the main switchboard displays information about the data processing system and a list bar which is the primary means of navigating through the data processing system.

72. The system of claim 71, wherein licensed users may click on icons in the main switchboard to open transaction forms, locate patient records in the data management system, transfer or download data to and from the data management system and maintain system tables in the data management system.

73. A method in an apheresis treatment data collection and treatment system, comprising the steps of:

(a) enabling a user to enter information about a patient in a computer database;

(b) creating a summary of the information entered into the local computer database;

(c) periodically transmitting the summarized information to a data management system database;

(d) allowing local users to search the data management system database for a specific patient profile;

(e) performing data aggregation and analysis on the data management system database and producing reports based on a search criterion; and

(f) allowing the local users to download the produced reports.

74. The method of claim 73, wherein the step of allowing the local users further comprises the step of enabling licensed users to establish the efficacy of RheoTherapy®

.

75. The method of claim 74, wherein the step of allowing further comprises the step of enabling licensed users to input data for each patient on several transaction forms which are accessed from a main switchboard in the data processing system.

76. The method of claim 75, further comprising the step of displaying on the main switchboard, information about the data processing system and a list bar which is the primary means of navigating through the data processing system.

77. The method of claim 76, further comprising the step of allowing licensed users to click on icons in the main switchboard to open transaction forms, locate patient records in the data management system, transfer or download data to and from the data management system and maintain system tables in the data management system.