US-20260124351-A1 - PERITONEAL DIALYSIS CYCLER HAVING DECREASED PH DISINFECTION

Abstract

A peritoneal dialysis (“PD”) system includes a plurality of PD fluid components, a reusable PD fluid line selectively fluidly communicating with the PD fluid components, a source of PD fluid selectively fluidly communicating with the reusable PD fluid line, a source of anti-scaling fluid selectively fluidly communicating with the reusable PD fluid line, and a control unit configured to (i) operate the plurality of PD fluid components during treatment using PD fluid from the source heated to a treatment temperature, and (ii) circulate unused PD fluid heated to a disinfection temperature in combination with anti-scaling fluid from the source of anti-scaling fluid after treatment for disinfecting the plurality of PD fluid components and the reusable PD fluid line, the anti-scaling fluid provided in an amount configured to lower the pH of the unused PD fluid to a level below which precipitates are formed and above which the pH causes disinfection.

Inventors

• Markus Nilsson
• Michael PETTERSSON
• Oskar Erik Frode Styrbjorn Fallman
• Per-Olof Borgqvist
• Sophie Sandblad

Assignees

• BAXTER INTERNATIONAL INC.
• BAXTER HEALTHCARE SA

Dates

Publication Date

20260507

Application Date

20251229

Claims (20)

1. 1 : A peritoneal dialysis (“PD”) system comprising: a plurality of PD fluid components; at least one reusable PD fluid line in fluid communication with the plurality of PD fluid components; a source of PD fluid in valved fluid communication with the at least one reusable PD fluid line; a source of anti-scaling fluid in valved fluid communication with the at least one reusable PD fluid line; and a control unit configured to (i) cause the plurality of PD fluid components to be operated during treatment using PD fluid from the source of PD fluid, the PD fluid heated to a treatment temperature, and (ii) cause unused PD fluid heated to a disinfection temperature after treatment to be circulated in combination with anti-scaling fluid from the source of anti-scaling fluid for disinfecting the plurality of PD fluid components and the at least one reusable PD fluid line, the anti-scaling fluid provided in an amount configured to lower a pH of the unused PD fluid to a level below which precipitates are formed and at or above a pH of 4.
2. 2 : The PD system of claim 1 , wherein the plurality of PD fluid components includes a PD fluid pump, the control unit configured to operate the PD fluid pump.
3. 3 : The PD system of claim 2 , wherein after the unused PD fluid heated to a disinfection temperature after treatment is circulated, the control unit causes the PD fluid pump to flush the plurality of PD fluid components and the at least one reusable PD fluid line.
4. 4 : The PD system of claim 1 , wherein the PD system further comprises a user interface communicatively coupled to the control unit.
5. 5 : The PD system of claim 4 , wherein the user interface is configured to provide an audio, visual, or audiovisual message indicating that a volume of the anti-scaling fluid is running low.
6. 6 : The PD system of claim 5 , wherein the control unit is configured to cause fresh anti-scaling fluid to be ordered and delivered when the volume of anti-scaling fluid is running low.
7. 7 : The PD system of claim 6 , wherein the user interface is configured to provide audio, visual, or audiovisual instruction as to how to re-supply the anti-scaling fluid after the fresh anti-scaling fluid has been delivered.
8. 8 : The PD system of claim 1 , wherein the anti-scaling fluid is citric acid.
9. 9 : The PD system of claim 1 , wherein the plurality of PD fluid components includes an air trap and a vent valve.
10. 10 : The PD system of claim 9 , wherein the air trap and vent valve are configured to assist with accommodating an excess amount of gas created during the combination of the unused PD fluid heated to a disinfection temperature with the anti-scaling fluid.
11. 11 : The PD system of claim 1 , further comprising a hose reel for maintaining the at least one reusable PD fluid line.
12. 12 : The PD system of claim 1 , further comprising an inline heater configured to heat the unused PD fluid to be combined with the anti-scaling fluid for disinfection.
13. 13 : A peritoneal dialysis (“PD”) system comprising: a plurality of PD fluid components; at least one reusable PD fluid line in fluid communication with the plurality of PD fluid components; a source of PD fluid in valved fluid communication with the at least one reusable PD fluid line; a source of anti-scaling fluid in valved fluid communication with the at least one reusable PD fluid line; and a control unit configured to (i) cause the plurality of PD fluid components to be operated during treatment using PD fluid from the source of PD fluid, the PD fluid heated to a treatment temperature, (ii) determine whether unused PD fluid from the source to be used for disinfection includes bicarbonate, (iii) when the unused PD fluid from the source to be used for disinfection includes bicarbonate, cause the unused PD fluid heated to a disinfection temperature after treatment to be circulated in combination with anti-scaling fluid from the source of anti-scaling fluid for disinfecting the plurality of PD fluid components and the at least one reusable PD fluid line, and (iv) send a message to a central location when the control unit determines that the anti-scaling fluid from the source of anti-scaling fluid is running low.
14. 14 : The PD system of claim 13 , wherein (ii) occurs before or after (i).
15. 15 : The PD system of claim 13 , wherein the PD system further comprises a user interface.
16. 16 : The PD system of claim 15 , wherein the control unit is configured to cause an audio, visual, or audiovisual message to appear on the user interface indicating that a volume of the anti-scaling fluid is running law.
17. 17 : The PD system of claim 13 , wherein the control unit is further configured to cause fresh anti-scaling fluid to be ordered and delivered after the control unit determines that the anti-scaling fluid from the source of anti-scaling fluid is running low.
18. 18 : The PD system of claim 13 , wherein the anti-scaling fluid is citric acid.
19. 19 : The PD system of claim 13 , wherein the control unit is further configured to flush the plurality of PD fluid components with unused PD fluid that has not been circulated in combination with anti-scaling fluid.
20. 20 : The PD system of claim 13 , wherein determining whether unused PD fluid from the source to be used for disinfection including bicarbonate includes determining a type of PD fluid to be used for disinfection.

Description

PRIORITY CLAIM This application claims priority to and the benefit of U.S. patent application Ser. No. 18/147,133 filed Dec. 28, 2022, which claims priority to and the benefit as a non-provisional application of U.S. Provisional Patent Application No. 63/294,172 filed Dec. 28, 2021, the entire contents of which are hereby incorporated by reference and relied upon. BACKGROUND The present disclosure relates generally to medical fluid treatments and in particular to dialysis fluid treatments. Due to various causes, a person's renal system can fail. Renal failure produces several physiological derangements. It is no longer possible to balance water and minerals or to excrete daily metabolic load. Toxic end products of metabolism, such as, urea, creatinine, uric acid and others, may accumulate in a patient's blood and tissue. Reduced kidney function and, above all, kidney failure is treated with dialysis. Dialysis removes waste, toxins and excess water from the body that normal functioning kidneys would otherwise remove. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is lifesaving. One type of kidney failure therapy is Hemodialysis (“HD”), which in general uses diffusion to remove waste products from a patient's blood. A diffusive gradient occurs across the semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion. Hemofiltration (“HF”) is an alternative renal replacement therapy that relies on a convective transport of toxins from the patient's blood. HF is accomplished by adding substitution or replacement fluid to the extracorporeal circuit during treatment. The substitution fluid and the fluid accumulated by the patient in between treatments is ultrafiltered over the course of the HF treatment, providing a convective transport mechanism that is particularly beneficial in removing middle and large molecules. Hemodiafiltration (“HDF”) is a treatment modality that combines convective and diffusive clearances. HDF uses dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance. In addition, substitution solution is provided directly to the extracorporeal circuit, providing convective clearance. Most HD, HF, and HDF treatments occur in centers. A trend towards home hemodialysis (“HHD”) exists today in part because HHD can be performed daily, offering therapeutic benefits over in-center hemodialysis treatments, which occur typically bi- or tri-weekly. Studies have shown that more frequent treatments remove more toxins and waste products and render less interdialytic fluid overload than a patient receiving less frequent but perhaps longer treatments. A patient receiving more frequent treatments does not experience as much of a down cycle (swings in fluids and toxins) as does an in-center patient, who has built-up two or three days' worth of toxins prior to a treatment. In certain areas, the closest dialysis center can be many miles from the patient's home, causing door-to-door treatment time to consume a large portion of the day. Treatments in centers close to the patient's home may also consume a large portion of the patient's day. HHD can take place overnight or during the day while the patient relaxes, works or is otherwise productive. Another type of kidney failure therapy is peritoneal dialysis (“PD”), which infuses a dialysis solution, also called dialysis fluid, into a patient's peritoneal cavity via a catheter. The dialysis fluid is in contact with the peritoneal membrane in the patient's peritoneal cavity. Waste, toxins and excess water pass from the patient's bloodstream, through the capillaries in the peritoneal membrane, and into the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. An osmotic agent in the PD dialysis fluid provides the osmotic gradient. Used or spent dialysis fluid is drained from the patient, removing waste, toxins and excess water from the patient. This cycle is repeated, e.g., multiple times. There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal peritoneal dialysis (“TPD”) and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow used or spent dialysis fluid to drain from the peritoneal cavity. The patient then switches fluid communication so that the patient catheter communicates with a bag of fresh PD fluid to infuse the fresh PD fluid through the catheter and into the patient. The patient disconnects the catheter from the fresh PD fluid bag and allows the dialysis fluid to dwell within the peritoneal cavity, wherein the transfer of waste, toxins and excess water takes place. After a dwell period, the patient repeats the manual dialysis procedure, fo