Technique for extracorporeal treatment of blood

• US 5,762,805 A
• Filed: 06/07/1995
• Issued: 06/09/1998
• Est. Priority Date: 02/12/1993
• Status: Expired due to Term

• Current Assignee: Gambro Renal Products, Inc. (Baxter International Inc.)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Manica, Keith, Eilers, George J., Miller, Douglas P., Corbin, Frank III, Lobdell, Donn D., Johnson, Steven H., Truitt, Lori A., Leppert, Lawrence L.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/480,489
• Time in Patent Office: 1,098 Days
• Field of Search: 210/85, 210/90, 210/96.1, 210/97, 210/101, 210/134, 210/138, 210/143, 210/195.2, 210/257.1, 210/257.2, 210/258, 210/259, 210/321.71, 210/416.1, 210/433.1 , 210/645, 210/646, 210/739, 210/649, 210/805, 210/929, 604/4, 604/5, 604/6, 604/65, 604/66, 604/67, 422/48, 177/45, 177/50, 364/184, 364/185, 364/188, 364/189, 364/413.01, 364/413.02, 364/413.07, 364/550, 364/552, 364/579, 364/567, 364/580, 364/581
• US Class Current: 210/645
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3451 the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/3468 using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/365 through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: C07K 14/4711 : Alzheimer's disease; Amyloid plaque core protein
• CPC Class Codes: C07K 16/40 : against enzymes
• CPC Class Codes: C12N 9/6421 : from mammals
• CPC Class Codes: G01N 33/573 : for enzymes or isoenzymes
• CPC Class Codes: G01N 33/6896 : Neurological disorders, e.g. Alzheimer's disease
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

Abstract

Blood from a patient is treated extracorporeally by any selected one of a plurality of predetermined treatments. Each of the treatments involves the flow of blood from the patient into a primary chamber of a filtration unit, past a semipermeable membrane located in the filtration unit which separates the primary chamber from a secondary chamber of the filtration unit, out the filtration unit and back to the patient. A replacement fluid is selectively and controllably added to the blood, as required for the selected treatment. A secondary fluid is controllably and selectively introduced into the secondary chamber of the filtration unit for controllably collecting material passing across the semipermeable membrane from the blood or for supplying material to pass across the semipermeable membrane into the blood as required for the selected treatment. Materials are removed from the secondary chamber and collected in accordance with the selected treatment. Blood leaks into the secondary chamber are automatically detected and the rates of blood and fluid flow automatically adjusted in response thereto. An apparatus which automatically performs and monitors the selected treatment is also described.

Claims

1. A method for treating blood from a patient extracorporeally by a treatment which transfers matter to or from the blood through a semipermeable membrane, the semipermeable membrane being part of a filtration unit of an apparatus and dividing the filtration unit into a primary chamber and a secondary chamber, the primary chamber receiving the blood and the matter transferred across the semipermeable membrane into the blood, the secondary chamber receiving the matter to be transferred into the blood and the matter transferred across the semipermeable membrane from the blood, said method comprising the steps of:

establishing an extracorporeal blood flow primary circuit from the patient through the primary chamber and back to the patient;

controlling the flow of blood through the primary circuit;

selectively supplying a replacement fluid to the blood in the primary circuit prior to returning the blood to the patient;

controlling the amount of the replacement fluid supplied to the blood in the primary circuit;

establishing a secondary circuit for the flow of fluid through the secondary chamber;

selectively supplying a one of a secondary fluid containing matter which is to be transferred across the semipermeable membrane into the blood or a secondary fluid to remove matter from the secondary chamber which has been transferred across the semipermeable membrane from the blood to the secondary chamber;

controlling the amount of secondary fluid supplied to the secondary chamber;

collecting fluid exiting from the secondary chamber;

controlling the amount of fluid collected from the secondary chamber;

selecting one of a plurality of different extracorporeal blood treatments to be performed by the apparatus;

frequently determining and automatically controlling the rate of flow of fluid through the primary circuit, the rate of flow of replacement fluid into the primary circuit, the rate of flow of secondary fluid into the secondary chamber and the rate of flow of fluid collected from the secondary chamber according to the extracorporeal blood treatment selected;

storing information defining which of the ones of the replacement fluid and the secondary fluid are to be supplied and defining the flow rates in the primary and secondary circuits for each of the plurality of treatments;

providing a blood leak detector;

detecting blood in the secondary circuit with the blood leak detector; and

during treatment periodically conducting self-tests of the blood leak detector to determine the operational integrity of the blood leak detector during treatment.

2. The method as defined in claim 1 further comprising the step of:

controlling the rate of fluid flow in the primary and secondary circuits in response to detecting a blood leak in the secondary circuit.

3. The method as defined in claim 1 further comprising the step of:

putting the apparatus in a safe state in response to detecting a blood leak in the secondary circuit.

4. The method as defined in claim 1, wherein the apparatus further includes a blood leak detector in the secondary circuit operative, said method further comprising the step of:

automatically detecting blood in the secondary circuit.