US-12623012-B2 - Peritoneal dialysis system including peristaltic pump

US12623012B2US 12623012 B2US12623012 B2US 12623012B2US-12623012-B2

Abstract

A peritoneal dialysis (“PD”) system includes a cycler having a peristaltic pump actuator; a disposable set including a pressure sensing manifold including first and second pressure sensing pods, a drain line and a first dialysis fluid/heater container line in fluid communication with the first pressure sensing pod, and at least one dialysis fluid container line and a patient line in fluid communication with the second pressure sensing pod; and a control unit programmed to operate the peristaltic pump actuator (i) in a first direction to pump fresh dialysis fluid along the at least one additional dialysis fluid container line into the first dialysis fluid/heater line and (ii) in a second direction to pump heated fresh dialysis fluid along the first dialysis fluid/heater line into the patient line. The pump actuator may be operated in the first direction again to pump used dialysis fluid from the patient to a drain.

Inventors

Karthik PITCHAIMANI
Anoop TA
Sadashiva KAMATH
Akhilesh SV

Assignees

VANTIVE US HEALTHCARE LLC
VANTIVE HEALTH GMBH

Dates

Publication Date: 20260512
Application Date: 20211207
Priority Date: 20201224

Claims (20)

1 . A peritoneal dialysis system comprising: a disposable set including a pressure sensing manifold including first and second pressure sensing pods, a drain line and a dialysis fluid/heater container line in fluid communication with the first pressure sensing pod, and at least one additional dialysis fluid container line and a patient line in fluid communication with the second pressure sensing pod; a cycler including: a peristaltic pump actuator, a first valve actuator configured to operate with the first pressure sensing pod to allow dialysis fluid to selectively flow to either the drain line or the dialysis fluid/heater container line, and a second valve actuator configured to operate with the second pressure sensing pod to allow dialysis fluid to selectively flow to either the patient line or one of the at least one additional dialysis fluid container line; and a control unit programmed to operate the peristaltic pump actuator (i) in a first direction to pump fresh dialysis fluid along the at least one additional dialysis fluid container line into the dialysis fluid/heater container line, and (ii) in a reverse, second direction to pump heated, fresh dialysis fluid along the dialysis fluid/heater container line into the patient line.
2 . The peritoneal dialysis system of claim 1 , further comprising a peristaltic pumping tube in fluid communication with the first and second pressure sensing pods.
3 . The peritoneal dialysis system of claim 1 , wherein at least one of the drain line or the dialysis fluid/heater container line is connected to a port extending from the first pressure sensing pod.
4 . The peritoneal dialysis system of claim 1 , wherein at least one of the at least one additional dialysis fluid container line or the patient line is connected to a port extending from the second pressure sensing pod.
5 . The peritoneal dialysis system of claim 1 , wherein the control unit is configured to use an output from the first pressure sensing pod as feedback to control pumping in the first direction at or below a positive system pressure limit for moving the fresh dialysis fluid to a dialysis fluid/heater container.
6 . The peritoneal dialysis system of claim 1 , wherein the control unit is configured to use an output from the second pressure sensing pod as feedback to control pumping in the first direction at or below a negative system pressure limit for moving the fresh dialysis fluid to a dialysis fluid/heater container.
7 . The peritoneal dialysis system of claim 1 , wherein the control unit is configured to use an output from the second pressure sensing pod as feedback to control pumping in the second direction at or below a positive patient pressure limit for moving the fresh dialysis fluid to a patient.
8 . The peritoneal dialysis system of claim 1 , wherein the control unit is configured to use an output from the second pressure sensing pod as feedback to control pumping in the first direction at or below a negative patient pressure limit for removing used dialysis fluid from a patient.
9 . The peritoneal dialysis system of claim 1 , wherein the first valve actuator includes a drain valve configured to operate with the drain line and a dialysis fluid/heater valve configured to operate with the dialysis fluid/heater container line, and the second valve actuator includes at least one additional dialysis fluid container valve configured to operate with the at least one additional dialysis fluid container line and a patient valve configured to operate with the patient line.
10 . The peritoneal dialysis system of claim 1 , wherein the cycler further includes a heater under control of the control unit for heating the fresh dialysis fluid delivered to a first dialysis fluid/heater container via the dialysis fluid/heater container line.
11 . The peritoneal dialysis system of claim 1 , wherein at least one of the first and second pressure sensing pods includes a flexible diaphragm that transmits fresh and used dialysis fluid pressure fluctuations to a pressure transmission fluid.
12 . The peritoneal dialysis system of claim 11 , wherein the flexible diaphragm is further configured to dampen pressure fluctuations.
13 . The peritoneal dialysis system of claim 1 , wherein the control unit is further configured to end a patient drain when a negative pressure increase is sensed by the second pressure sensing pod while the peristaltic pump actuator is operated in the first direction to pump used dialysis fluid from the patient line.
14 . The peritoneal dialysis system of claim 13 , wherein the control unit is configured to end the patient drain when the negative pressure increase is sensed and the control unit has determined that at least a threshold amount of the used dialysis fluid has been removed from a patient.
15 . The peritoneal dialysis system of claim 13 , wherein the control unit is configured to end the patient drain when the negative pressure increase is sensed and after a pushback of the used dialysis fluid in the patient line by the peristaltic pump actuator operating in the second direction fails to remove the negative pressure increase.
16 . The peritoneal dialysis system of claim 1 , wherein the control unit is further configured to determine that a patient line occlusion has occurred when the second pressure sensing pod senses an increase in positive pressure in the patient line while moving the fresh dialysis fluid to a patient.
17 . The peritoneal dialysis system of claim 1 , wherein the control unit is further configured to determine that a patient line occlusion has occurred when the second pressure sensing pod senses an increase in negative pressure in the patient line while removing used dialysis fluid from a patient.
18 . The peritoneal dialysis system of claim 1 , wherein the control unit is further configured to perform a patient fill according to a fill profile in which a speed of the peristaltic pump actuator operating in the second direction is increased for a middle portion of the patient fill.
19 . The peritoneal dialysis system of claim 1 , wherein the control unit is further configured to perform a patient drain according to a drain profile in which a speed of the peristaltic pump actuator operating in the first direction is increased for a middle portion of the patient drain.
20 . The peritoneal dialysis system of claim 1 , wherein the peristaltic pump actuator is positioned relative to the cycler such that the first and second pressure sensing pods, the drain line, the dialysis fluid/heater container line, the at least one additional dialysis fluid container line, and the patient line are oriented at least substantially horizontally for treatment.

Description

PRIORITY CLAIM The present application is a national phase entry of PCT Patent Application No. PCT/US2021/062199, filed on Dec. 7, 2021, which claims priority to and the benefit of Indian Patent Application number 202041056330, filed on Dec. 24, 2020, the entirety of which are herein incorporated by reference. TECHNICAL FIELD The present disclosure relates generally to medical fluid treatments and in particular to dialysis fluid treatments. BACKGROUND 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 chamber via a catheter. The dialysis fluid is in contact with the peritoneal membrane in the patient's peritoneal chamber. 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 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 flow dialysis 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 chamber. The patient then switches fluid communication so that the patient catheter communicates with a bag of fresh dialysis fluid to infuse the fresh dialysis fluid through the catheter and into the patient. The patient disconnects the catheter from the fresh dialysis fluid bag and allows the dialysis fluid to dwell within the peritoneal chamber, wherein the transfer of waste, toxins and excess water takes place. After a dwell period, the patient repeats the manual dialysis procedure, for example, four times per day. Manual pe