Claims for Patent: 10,155,076

Summary for Patent: 10,155,076

Title:	Method for treating dialysate, dialysis system, and method for pre-evaluating dialysis patients for treatment with same
Abstract:	A method for treating dialysate solutions used in dialysis wherein dialysate is treated in an early part of a dialysis treatment session by external infusion of bicarbonate solution into the dialysate circuit to eliminate the need for bicarbonate requirements in concentrates used for preparation of precursor dialysate (priming) solutions and/or for a solid bicarbonate layer in a sorbent cartridge. Dialysate is treated in a latter part of a dialysis treatment session by introduction of sterile dilution water to reduce sodium concentration in the dialysate. The method provides a more efficient and reduced use of dialysate fluids, electrolytes, sorbent cartridge materials, equipment scale, or any combinations of these, while maintaining purity standards and applicable physiological ranges for bicarbonate, sodium, and other dialysate solution components over the course of a dialysis treatment session.
Inventor(s):	Merchant; Stephen (Oklahoma City, OK)
Assignee:	Fresenius Medical Care Holdings, Inc. (Waltham, MA)
Application Number:	14/723,493
Patent Claims:	1. A dialysis system comprising: a dialyzer comprising a blood flow path, a dialysate flow path, a dialysate inlet for receiving fresh or regenerated dialysate into the dialyzer, and a dialysate outlet for discharging spent (used) dialysate from the dialyzer; a sorbent cartridge configured for regenerating spent dialysate, the sorbent cartridge comprising a sorbent cartridge inlet and a sorbent cartridge outlet; a fluid circuit comprising a first fluid passageway configured to provide fluid communication between the dialysate outlet of the dialyzer and the sorbent cartridge inlet, and a second fluid passageway configured to provide fluid communication between the sorbent cartridge outlet and the dialysate inlet of the dialyzer; a source of bicarbonate solution which is fluidly coupled to the second fluid passageway; a pump or orifice flow controller for delivery of the bicarbonate solution at a controlled rate from the source of bicarbonate solution into the second fluid passageway wherein said orifice flow controller having a body that defines an orifice or flow passageway through which fluid flows from tubing fluidly coupled at an inlet of the orifice flow controller to tubing fluidly coupled at the outlet of the orifice flow controller; and a supply of sterile water which is fluidly coupled to the second fluid passageway for introducing sterile water into the second fluid passageway from the supply container of sterile water wherein the pump or orifice flow controller is controlled by an electronic controller, which is configured to introduce the bicarbonate into the regenerated dialysate during a first dialysis treatment time period to provide a treated regenerated dialysate that is circulated to the dialyzer; and said supply of sterile water is controlled by the same or different electronic controller, such that the sterile water is added to the regenerated dialysate during a second dialysis treatment time period occurring after the first dialysis treatment time period to provide a diluted regenerated dialysate that is circulated to the dialyzer and wherein the first dialysis treatment time period occurs within an initial 50% of total dialysis treatment time of a dialysis treatment session, and the second dialysis treatment time period occurs within a final 50% of the total dialysis treatment time of the same dialysis treatment session. 2. The dialysis system of claim 1, wherein the pump is present for delivery of the bicarbonate solution and is a programmable pump, and the supply of sterile water comprises a bag of sterile water that is hung at a raised position relative to the second fluid passageway for gravity feeding of the sterile water into the second fluid passageway. 3. The dialysis system of claim 1, wherein the supply of sterile water comprises a container having a maximum volume of sterile water of about 2.0 liters or less. 4. The dialysis system of claim 1, wherein the supply of sterile water comprises sterile water held in a container for flow of the sterile water into the second fluid passageway, wherein the second fluid passageway comprises a tubing system, the tubing system comprises a first primary tube, an orifice flow controller, and a second primary tube, wherein i) the first primary tube fluidly connects the supply container and the orifice flow controller, wherein the first primary tube has a first inside diameter, ii) the second primary tube fluidly connecting the orifice flow controller and the fluid circuit, wherein the second primary tube has a second inside diameter, iii) the orifice flow controller defines an orifice having a reduced diameter relative to the first and second diameters, wherein flow of regenerated dialysate through the fluid circuit creating a fluid pressure differential relative to the supply of sterile water in the container to induce flow of sterile water from the supply of sterile water in the container through the tubing system into the fluid circuit at a controlled flow rate via the orifice flow controller. 5. The dialysis system of claim 1, wherein the sorbent cartridge comprises at least one activated carbon layer, at least one urease-containing layer, at least one zirconium phosphate-containing layer, and at least one zirconium oxide-containing layer. 6. The dialysis system of claim 5, wherein the sorbent cartridge is free of a solid particulate bicarbonate layer. 7. The dialysis system of claim 1, further comprising an expandable reservoir, first tubing, and second tubing, wherein the expandable reservoir comprising a flexible bag having a reservoir inlet, a reservoir outlet, and a bottom portion defining progressively reducing cross-sectional area in a direction extending from the reservoir inlet towards the reservoir outlet, wherein fluid is held within the expandable reservoir in progressively smaller cross-sectional areas nearer to the reservoir outlet; the second tubing configured to provide a fluid communication of regenerated dialysate discharged from the sorbent cartridge and any sterile water to the reservoir inlet; and a third tubing configured to provide a fluid communication of regenerated dialysate and any sterile water from the reservoir outlet to the dialysate inlet of the dialyzer. 8. The dialysis system of claim 1, wherein the source of bicarbonate solution and the supply of sterile water are controllable for dispensing or not dispensing. 9. The dialysis system of claim 8, wherein the source of bicarbonate solution and the supply of sterile water are controllable for dispensing, and the source of bicarbonate solution and the supply of sterile water are controlled based on signals provided by a controller. 10. The dialysis system of claim 9, wherein the controlling is based on if the patient needs one or other of the bicarbonate solution and the sterile water added to the dialysate. 11. The dialysis system of claim 10, wherein the patient needing one or other of the bicarbonate solution and the sterile water added to the dialysate or not is based on pre-dialysis testing and/or prior patient history and/or using one or more pre-screening factors to determine expected needs of patient.

Details for Patent 10,155,076

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2034-05-29