Automatic priming technique

• US 5,776,345 A
• Filed: 06/07/1995
• Issued: 07/07/1998
• 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, Miller, Douglas P., Truitt, Lori A.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/472,676
• Time in Patent Office: 1,126 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, 210/321.6, 210/416.1 , 210/433.1, 210/645, 210/646, 210/650, 210/649, 210/739, 210/805, 210/929, 210/741, 604/4, 604/5, 604/6, 604/65, 604/66, 604/67, 422/48, 364/184, 364/185, 364/188, 364/189, 364/413.01, 364/413.02, 364/413.07, 364/550, 364/552, 364/579, 364/580
• 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. Upon selection of one of the plurality of extracorporeal blood treatments available, the primary and secondary circuits are automatically primed with a priming fluid, in accordance with the selected treatment. An apparatus which automatically performs and monitors the selected treatment is also described.

Claims

1. An apparatus for treating blood from a patient extracorporeally by a treatment which transfer matter to or from the blood through a semipermeable membrane in a filtration unit, the semipermeable membrane dividing the filtration unit into a primary chamber and a secondary chamber, the primary chamber receiving the blood and the matter diffused across the semipermeable membrane into the blood, the secondary chamber receiving the matter to be diffused into the blood and the matter transferred across the semipermeable membrane from the blood, said apparatus comprising:

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

a primary pump connected in the extracorporeal circuit and operative for controlling the flow of blood through th primary circuit;

replacement fluid supply connected in the primary circuit and operative for supplying a replacement fluid to the blood in the primary circuit;

a replacement fluid pump operatively coupled to the replacement fluid supply and operative for controlling the amount of replacement fluid supplied to the blood in the extracorporeal circuit;

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

a secondary fluid supply connected to the secondary circuit and operative for supplying one of a secondary fluid containing matter which is to be diffused 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;

a secondary fluid pump operatively coupled to the secondary fluid supply for controlling the amount of secondary fluid supplied to the secondary chamber;

a collection reservoir connected to the secondary flow circuit and operative for collecting fluid exiting from the secondary chamber;

a collection pump operatively coupled to the collection reservoir and operative for controlling the amount of fluid collected from the secondary chamber;

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

memory for storing information defining the flow rates and priming protocols in relationship to the treatment selected and for storing information describing the ones of the replacement fluid and the secondary supply fluid which are to be selectively supplied and the collection fluid which is to be selectively collected according to the type of treatment selected; and

a controller connected to the input device, the primary pump, the replacement fluid pump, the secondary fluid pump and the collection pumps operatively coupled to the memo and operative prior to treatment in response to the selection of each type of treatment and based on the priming protocol stored in the memory, for automatically priming the primary and secondary circuits, fully priming portions of the primary and secondary circuits to be used during the selected treatment and partially filling with priming fluid those portions of the primary and secondary circuits not to be used during the selected treatment.

2. The apparatus as defined in claim 1 further comprising:

anticoagulant supply means connected to the primary circuit; and

anticoagulant pump means connected to the anticoagulant supply means and controller means and operative for automatically dispensing anticoagulant from the anticoagulant supply means into the blood of the primary circuit in accordance with a stored flow rate.

3. An apparatus for treating blood from a patient extracorporeally in accordance with claim 1 wherein the treatment selected is UF and wherein the portion of the primary circuit attached to the replacement fluid supply and the portion of the secondary circuit attached to the secondary fluid supply are partially filled with priming fluid.

4. An apparatus for treating blood from a patient extracorporeally in accordance with claim 1 wherein the treatment selected is HF and wherein the portion of the secondary circuit attached to the secondary fluid supply is partially filled with priming fluid.

5. An apparatus for treating blood from a patient extracorporeally in accordance with claim 1 wherein the treatment selected is HD and wherein the portion of the primary circuit connected to the replacement fluid supply is partially filled with priming fluid.

6. 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;

automatically moving a priming fluid into the primary and secondary circuits prior to treatment according to the extracorporeal blood treatment selected, fully priming portions of the primary and secondary circuits to be used during the selected treatment and partially filling with priming fluid those portions of the primary and secondary circuits not to be used during the selected treatment;

initiating the selected treatment;

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; and

storing information defining which of the ones of the replacement fluid and the secondary fluid are to be supplied for each of the plurality of treatments.

7. The method according to claim 6, wherein the step of automatically moving a priming fluid into the primary and secondary circuits further includes the step of ultrafiltering at least a portion of the priming fluid in the primary circuit into the secondary circuit.

8. The method according to claim 6, wherein the step of automatically moving a priming fluid into the primary and secondary circuits includes the step of establishing a flow of priming fluid through the primary chamber in a reverse direction to the direction of blood flow in the primary circuit established in the extracorporeal blood flow establishing step.

9. The method according to claim 6, wherein the plurality of treatments includes UF, HF and HD, and wherein when UF is selected then the portions of both the primary circuit and the secondary circuit are partially filled with priming fluid, when HF is selected then a portion of the secondary circuit is partially filled with priming fluid, and when HD is selected then a portion of the primary circuit is partially filled with priming fluid.

10. Method for controlling and monitoring the circulation of body fluids and medical fluids through a circuit for multiple blood extracorporeal treatments, said circuit comprising:

a filtration unit having a primary and a secondary chamber separated by a semipermeable membrane, each chamber having an inlet and an outlet;

a primary circuit comprising a blood access line connected to the inlet of the primary chamber and a blood return line connected to the outlet of the primary chamber;

a secondary circuit comprising a secondary fluid line connected to the inlet of the secondary chamber and a collection fluid line connected to the outlet of the secondary chamber;

a replacement fluid line connected to the primary circuit;

an anticoagulant fluid line connected to the blood access line; and

memory for storing preprogrammed information selected from the group consisting of preprogrammed priming fluid instructions, priming protocols, and priming times for each of the multiple extracorporeal blood treatments;

the method comprising the steps of;

defining for a specific treatment the flow rates of body fluids and medical fluids through the circuit for multiple extracorporeal blood treatments;

in accordance with a selected one or more of the stored priming fluid instructions, priming times and priming protocols for the specific treatment, priming at least the primary circuit and at least one part of the secondary circuit by circulating a priming fluid from an end of the blood return line, through the primary chamber, and to an end of the blood access line, for the predetermined priming time for the specific treatment, and then ultrafiltering priming fluid from the primary chamber into the secondary chamber;

in accordance with the selected one or more of the stored priming fluid instructions, priming times and priming protocols for the specific treatment, fully priming the ones of the replacement fluid line, the secondary fluid line and the collection line to be used during the defined treatment;

in accordance with the selected one or more of the stored priming fluid instructions, priming times and priming protocols for the specific treatment, partially filling with priming fluid the ones of the replacement fluid line and the secondary fluid line not to be used during the defined treatment;

connecting the primary circuit to a vascular system of a patient;

circulating blood, anticoagulant fluid, replacement fluid, secondary fluid and collection fluid in the circuit for multiple blood extracorporeal treatments according to the corresponding flow rates previously defined;

monitoring a pressure in at least one of the blood access line, the blood return line and the collection fluid line;

monitoring a flow rate of liquid in at least one of the primary circuit, the anticoagulant fluid line, the replacement fluid line, the secondary fluid line and the collection fluid line; and

stopping the circulation of at least one circulating fluid in the circuit for multiple extracorporeal blood treatments when predetermined alarm conditions occur.

11. Method according to claim 10, further comprises:

circulating priming liquid from the secondary chamber to an end of the collection fluid line.

12. Method according to claim 10, further comprising:

when the primary circuit is filled with priming fluid, pumping priming fluid from the primary circuit into the replacement fluid line in order to fill, at least partially, the replacement fluid line with priming fluid.

13. Method according to claim 10, further comprising:

when the secondary chamber is filled with priming fluid, pumping priming fluid from the secondary chamber into the secondary fluid line in order to fill, at least partially, the secondary fluid line with priming fluid.

14. Method according to claim 10, further comprising:

priming the replacement fluid line by circulating replacement fluid in the replacement fluid line for a predetermined fraction of the priming time.

15. Method according to claim 10, further comprising:

priming the secondary fluid line by circulating secondary fluid in the secondary fluid line for a predetermined fraction of the priming time.

16. Method according to claim 10, further comprising, when the priming time has elapsed, the steps of:

closing the blood return line;

pumping priming fluid into the blood access line in order to increase the pressure in the primary circuit from an initial value to a predetermined pressure;

sensing the pressure in the primary circuit for a predetermined period of time; and

either

emitting an alarm if the predetermined pressure is not reached or if the pressure decreases, or

allowing the pressure to decrease if the pressure remains substantially constant for the predetermined period of time.

17. Method according to claim 16, wherein the step of allowing the pressure to decrease in the primary circuit comprises:

pumping priming fluid from the blood access line until the pressure in the circuit decreases to the initial value; and

opening the return line.

18. A method in accordance with claim 10, wherein the treatment defined is UF and wherein the replacement fluid line and the secondary fluid line are partially filled with priming fluid.

19. A method in accordance with claim 10 wherein the treatment defined is HF and wherein the secondary fluid line is partially filled with priming fluid.

20. A method in accordance with claim 10 wherein the treatment defined is HD and wherein the replacement fluid line is partially filled with priming fluid.