# US 5,346,472 A · Apparatus and method for preventing hypotension in a dialysis patient

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- Number: US 5,346,472 A
- Document ID: US5346472A
- Status: Granted
- Kind: A
- Application number: 08/072,413
- Filed: 1993-06-02
- Granted: 1994-09-13
- Earliest claimed: 1993-06-02
- Assignees: Baxter International Inc.
- Inventors: Prakash R. Keshaviah; Jian Ruan; Jim Ebben; Dave Luhring; Charles J. Dubauskas
- Web page: https://patentgrep.com/patent/US5346472A

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/1605: {Physical characteristics of the dialysate fluid}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An automatic means and method for preventing and/or treating hypotension in hemodialysis patients. To this end, a system is provided wherein the patient or healthcare practitioner can cause the hemodialysis machine to automatically deliver sodium to the patient through the dialysate so as to increase blood and extracellular osmolarity, increase blood volume from vascular refilling, and raise blood pressure. This would thereby alleviate any clinical symptoms caused by hypotension during hemodialysis.

## Claims

### Claim 1

A method for preventing hypotension in a patient receiving hemodialysis comprising the steps of providing a means for generating a signal, and automatically delivering to the patient, through a dialyzer, sodium in response to said signal generated by the patient or other person wherein the signal is generated by the patient or the other person actuating a switch on a controller extending from a hemodialysis machine.

### Claim 2 (depends on 1)

The method of claim 1 including the step of adjusting the concentration of sodium delivered over a predetermined period of time in response to other parameters.

### Claim 3 (depends on 1)

The method of claim 1 including the step of delivering a predetermined concentration of sodium in response to the signal by adjusting a length of time over which the sodium is delivered in response to other parameters.

### Claim 4 (depends on 1)

The method of claim 1 wherein a concentration of sodium to be delivered and a length of time over which the sodium is delivered is fixed.

### Claim 5 (depends on 1)

The method of claim 1 including the step of using hardware, at least in part, to automatically deliver the sodium to the patient.

### Claim 6 (depends on 1)

The method of claim 1 wherein the step of automatically delivering is, at least in part, controlled by software.

### Claim 7 (depends on 1)

The method of claim 1 including the step of using a hemodialysis machine having a dual variable proportioning pump.

### Claim 8 (depends on 1)

The method of claim 1 including the step of restricting the sodium delivered to the patient to a predetermined number of milliequivalents.

### Claim 9

A method for providing hemodialysis to a patient comprising the steps of:
passing, at least a portion of, a patient's blood through a dialyzer that uses a dialysate, that includes an amount of sodium, to remove metabolic waste from the blood; and
automatically increasing the amount of sodium in the dialysate in response to a signal generated by the patient or healthcare personnel wherein the signal is generated by the patient or the healthcare personnel actuating a switch on a controller extending from a hemodialysis machine.

### Claim 10 (depends on 9)

The method of claim 9 including the step of adjusting the concentration of sodium delivered over a predetermined period of time in response to other parameters.

### Claim 11 (depends on 9)

The method of claim 9 including the step of delivering a predetermined concentration of sodium in response to the signal but adjusting a length of time over which the sodium is delivered in response to other parameters.

### Claim 12 (depends on 9)

The method of claim 9 wherein a concentration of sodium to be delivered and a length of time over which the sodium is delivered is fixed.

### Claim 13 (depends on 9)

The method of claim 9 including the step of using a hemodialysis machine having a dual variable proportioning pump.

### Claim 14 (depends on 9)

The method of claim 9 including the step of restricting the sodium delivered to the patient to a predetermined number of milliequivalents.

### Claim 15

A hemodialysis system for providing hemodialysis to a patient comprising:
means for removing through the use of a dialysate, that includes an amount of sodium, metabolic waste from a patient's blood stream;
means for increasing in the dialysate the amount of sodium in response to a signal; and
means for allowing the patient or healthcare practitioner to generate the signal wherein the signal is generated by the patient or the healthcare personnel actuating a button on a controller extending from a hemodialysis machine.

### Claim 16 (depends on 15)

The hemodialysis system of claim 15 including the step of adjusting the concentration of sodium delivered over a predetermined period of time in response to other parameters.

### Claim 17 (depends on 15)

The hemodialysis system of claim 15 including means for delivering a predetermined concentration of sodium in response to the signal by adjusting a length of time over which the sodium is delivered in response to other parameters.

### Claim 18 (depends on 15)

The hemodialysis machine of claim 15 including means for insuring that a concentration of sodium to be delivered and a length of time over which the sodium is delivered is fixed.

### Claim 19 (depends on 15)

The hemodialysis machine of claim 15 wherein the hemodialysis machine includes a dual variable proportioning pump.

### Claim 20 (depends on 15)

The hemodialysis machine of claim 15 including means for restricting the sodium delivered to the patient to a predetermined number of milliequivalents.

### Claim 21

A method for preventing hypotension in a patient receiving hemodialysis comprising the steps of:
providing a means for generating a signal;
automatically delivering to the patient, through a dialyzer, sodium in response to a signal generated by the patient or other person;
entering into a delivery system, for delivering sodium to the dialysate, a patient's standard dialyzer clearance at a given blood and dialysate flow rate and the patient's sodium concentration and blood flow;
calculating the mass transfer area coefficient for the dialyzer; and
automatically, through the system, determined the total number of milliequivalents that will be required by the patient to remove hypotension.

### Claim 22

A method of providing hemodialysis to a patient comprising the steps of:
passing, at least a portion of, a patient's blood through a dialyzer that uses a dialysate, that includes an amount of sodium, to remove metabolic waste from the blood; and
automatically increasing the amount of sodium in the dialysate in response to a signal generated by the patient or healthcare personnel;
entering into a delivery system, for delivering sodium to the dialysate, a patient's standard dialyzer clearance at a given blood and dialysate flow rate and the patient's sodium concentration and blood flow;
calculating the mass transfer area coefficient for the dialyzer; and
automatically, through the system, determining the total number of milliequivalents that will be required by the patient to prevent hypotension.
