Rheological treatment methods and related apheresis systems

• US 6,551,266 B1
• Filed: 12/28/1999
• Issued: 04/22/2003
• Est. Priority Date: 12/29/1998
• Status: Expired due to Fees

• Current Assignee: Tearlab Corp.
• Original Assignee: OccuLogix Corporation
• Inventors: Davis, Richard C. Jr.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/472,903
• Time in Patent Office: 1,211 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.04, 604/6.09, 604/6.01, 604/48, 422/44, 422/45, 210/650
• US Class Current: 604/6.09
• 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 method of providing membrane differential blood filtration treatment comprising:

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

(d) selecting a particular membrane differential blood filtration treatment protocol appropriate for chronic versus acute medical situations; and

(e) providing membrane differential blood filtration treatment.

2. The method of claim 1 wherein the step of selecting a particular membrane differential blood filtration treatment protocol includes an evaluation of a database containing data on other patients treated by membrane differential blood filtration.

3. The method of claim 1, further comprising the step of providing disease-specific medical follow-up evaluations.

4. The method of claim 3, further comprising the step of submitting data on the patient to a database containing data on other patients treated by membrane differential blood filtration.

5. 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.

6. 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.

7. The method of claim 6, 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.

8. The method of claim 6, 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.

9. The method of claim 6, 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.

10. The method of claim 9, 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.

11. 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.

12. The method of claim 11, 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.

13. A method of screening patients for a membrane differential 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 membrane differential blood filtration treatment or who will not be harmed by the treatment; and

, optionally,

(d) selecting a particular membrane differential blood filtration treatment appropriate for treating a specific RAM associated disease.

14. The method of claim 13, wherein the step of selecting a particular membrane differential blood filtration treatment further includes screening a database containing patient data from individuals treated by membrane differential blood filtration to determine the most appropriate treatment protocol.

15. The method of claim 13, further comprising the step of submitting data in a patient profile to a database containing patient data from other membrane differential blood filtration treatment patients.