US-12618704-B2 - Medical treatment system and methods using a plurality of fluid lines

Abstract

A system including a pumping cassette having a first side including number of valve wells and second side having a fluid bus. Each side may be covered by a flexible membrane. A control surface having a number of valve well control stations actuatable with respect to the flexible membrane covering the first side of the cassette to open and close the valve wells when the cassette is mated against the control surface may be included. A pressure distribution assembly having a positive and negative pressure source and a number of pneumatic valves may be included. A controller configured to selectively actuate the number of pneumatic valves to apply pressure against the valve well control stations in a valve pumping sequence until a volume displaced through the fluid bus of the pumping cassette from a source to a destination is within a range of a target volume may be included.

Inventors

• Daniel S. Karol

Assignees

• DEKA PRODUCTS LIMITED PARTNERSHIP

Dates

Publication Date

20260505

Application Date

20240315

Claims (20)

1. 1 . A system for determining a characteristic correlated to a heightwise location of a component of interest relative to a pumping chamber of a fluid handling set, the system comprising: a pumping cassette including the pumping chamber and having at least a first fluid valve, and a second fluid valve leading to a port connected to a fluid line coupled to the component of interest; a pressure distribution module having a control surface against which the pumping cassette is disposed and including at least one sensor configured to output sensor data indicative of a pressure of the pumping chamber; and a controller configured to command the pressure distribution module to establish a path from the port to the pumping chamber, receive the sensor data, and detect a feature profile in the sensor data, the controller configured to predict the characteristic of the component of interest based on the feature profile and additional temporal data associated with the feature profile.
2. 2 . The system of claim 1 , wherein the controller is configured to predict the characteristic using a behavior model.
3. 3 . The system of claim 2 , wherein the behavior model is based off an ideal second order undampened system.
4. 4 . The system of claim 1 , wherein the feature profile includes one or more pressure peak.
5. 5 . The system of claim 1 , wherein the feature profile includes a first pressure peak and a second pressure peak lower in magnitude than the first peak.
6. 6 . The system of claim 1 , wherein the controller is configured to set an adjusted pumping pressure value based on the predicted characteristic.
7. 7 . The system of claim 1 , wherein while the controller is detecting the feature profile, the controller is also configured to orchestrate pumping of fluid through the pumping cassette via actuation of one or more pneumatic valves in the pressure distribution module associated with a second pump chamber in the pumping cassette.
8. 8 . A system for determining a value dependent upon a heightwise location of a component of interest relative to a pumping chamber of a fluid handling set, the system comprising: a pumping cassette including the pumping chamber, and a plurality of valves, at least one of the valves disposed intermediate the pumping chamber and the component of interest; a pressure distribution module having a control surface against which the pumping cassette is retained, the pressure distribution module including at least one sensor configured to output sensor data indicative of a pressure of the pumping chamber; and a controller configured to command the pressure distribution module to establish a path from the component of interest to the pumping chamber, receive the sensor data, and detect a feature profile in the sensor data, the controller configured to predict the value dependent upon the heightwise location based on the feature profile before the sensor data has stabilized.
9. 9 . The system of claim 8 , wherein the feature profile includes one or more pressure peak.
10. 10 . The system of claim 8 , wherein the feature profile includes a first pressure peak and a second pressure peak lower in magnitude than the first peak.
11. 11 . The system of claim 8 , wherein the controller is configured to set an adjusted pumping pressure value based on the value dependent upon the heightwise location.
12. 12 . A system for detecting a heightwise location of a component of interest comprising: a pumping cassette including a pumping chamber, and a set of fluid valves, a first fluid valve of the fluid valves being intermediate the pumping chamber and the component of interest; a pressure distribution module having a control surface for receipt of the pumping cassette and including at least one sensor configured to output sensor data indicative of a pressure of the pumping chamber; and a controller configured to command the pressure distribution module to establish a path from the component of interest to the pumping chamber, receive the sensor data, and detect a feature profile in the sensor data before the sensor data indicates the pressure in the pumping chamber is stable, the controller configured to set, based on the feature profile, a heightwise location value for the component of interest from a list consisting of: a value dependent upon the heightwise location of the component of interest, and a headheight value of the component of interest.
13. 13 . The system of claim 12 , wherein the feature profile includes one or more pressure peak.
14. 14 . The system of claim 12 , wherein the feature profile includes a first pressure peak and a second pressure peak lower in magnitude than the first peak.
15. 15 . The system of claim 12 , wherein the controller is configured to set an adjusted pumping pressure value based on the heightwise location value.
16. 16 . The system of claim 12 , wherein the controller is further configured to actuate one or more pneumatic valve of the pressure distribution module to apply pressure to the control surface and consequentially place the pumping chamber in an intermediary state between a fully filled and fully delivered state before establishing the path from the component of interest to the pumping chamber.
17. 17 . The system of claim 16 , wherein the intermediary state is a state that allows for the detection of a maximum positive and maximum negative head height of about the same absolute value.
18. 18 . The system of claim 12 , wherein the controller is further configured to actuate one or more pneumatic valve of the pressure distribution module to apply pressure to the control surface and consequentially place the pumping chamber in a negative head height detection biased state before establishing the path from the component of interest to the pumping chamber.
19. 19 . The system of claim 12 , wherein the controller is further configured to actuate one or more pneumatic valve of the pressure distribution module to apply pressure to the control surface and consequentially place the pumping chamber in a positive head height detection biased state before establishing the path from the component of interest to the pumping chamber.
20. 20 . The system of claim 12 , wherein the controller is configured to compare the heightwise location value to an expected heightwise location range and generate an error signal when the heightwise location value is outside of the expected range.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Divisional of U.S. patent application Ser. No. 16/384,082, filed on Apr. 15, 2019, now US2019/0316948A1, published Oct. 17, 2019, and entitled Medical Treatment System and Methods Using a Plurality of Fluid Lines which claims the benefit of U.S. Provisional Application Ser. No. 62/658,731 filed Apr. 17, 2018 and entitled Medical Treatment System and Methods Using a Plurality of Fluid Lines, each of which being hereby incorporated herein by reference in their entireties. BACKGROUND Peritoneal Dialysis (PD) involves the periodic infusion of sterile aqueous solution (called peritoneal dialysis solution, or dialysate) into the peritoneal cavity of a patient. Diffusion and osmosis exchanges take place between the solution and the bloodstream across the natural body membranes. These exchanges transfer waste products to the dialysate that the kidneys normally excrete. The waste products typically consist of solutes like sodium and chloride ions, and other compounds normally excreted through the kidneys like urea, creatinine, and water. The diffusion of water and solutes across the peritoneal membrane during dialysis is called ultrafiltration. A popular form of PD is Automated Peritoneal Dialysis or APD. APD uses a machine, called a cycler, to automatically infuse, dwell, and drain peritoneal dialysis solution to and from the patient's peritoneal cavity. APD is particularly attractive to a PD patient, because it can be performed at home and at night while the patient is asleep. This frees the patient from the day-to-day demands of manually administered peritoneal dialysis (known as CAPD) during his/her waking and working hours. The APD sequence or therapy typically lasts for several hours. It often begins with an initial drain phase to empty the peritoneal cavity of spent dialysate. The APD sequence then proceeds through a succession of fill, dwell, and drain phases that follow one after the other. Each sequencing including a fill/dwell/drain is called a cycle. During the fill phase, the cycler transfers a predetermined volume of fresh, warmed dialysate into the peritoneal cavity of the patient. The dialysate remains (or “dwells”) within the peritoneal cavity for a period of time. This is called the dwell phase. During the drain phase, the cycler removes the spent dialysate from the peritoneal cavity. The number of cycles that are required during a given APD session depends upon the total volume of dialysate prescribed for the patient's APD regimen, and is either entered as part of the treatment prescription or calculated by the cycler. Conventional peritoneal dialysis solutions typically come in the form of a premixed bag which contains electrolytes and dextrose in concentrations sufficient to generate the necessary osmotic pressure to remove water and solutes from the patient through ultrafiltration. These bags vary in size, but can range up to five or more liters. As several bags of dialysate are generally consumed during a therapy, the patient must maintain a stockpile of a large number of bags in their home to ensure appropriate supplies for continued therapy are available. It is recommended to keep about a month worth or more of supplies on hand. These bags may take up significant space. Additionally, these bags can be heavy making them difficult for patients to move about during set up. More recently, there has been a focus on creating new PD solutions which are more physiologically biocompatible. This research is in progress and some solutions which are purported to be more physiologically biocompatible are currently on the market. Like conventional solutions, these are provided in bags which contain the full volume of fluid to be used during the therapy. Some of these bags may be compartmented and rely on the user manually manipulate the bag and to mix compartments prior to therapy. This is done since the mixed dialysate is intended for immediate use and does not have a long storage life in mixed state. Such a dialysate solution is evidenced to support better patient outcomes, but may contribute to increased waste, set-up burden, and introduce mixing variability from patient to patient. Per the Center for Drug Evaluation and Research of the FDA, “manufacturing a sterile fluid like PD solution is highly specialized and complex, and there are limited numbers of manufacturing lines at each company that are capable of making these solutions.” Expansion of production “can take months to years for a firm to complete necessary planning and development to initiate the new production lines successfully.” Thus, as APD has become a modality of choice for dialysis patients, production of fluids has, in some instances, been unable to keep pace. It is projected that strong future growth in APD will outpace dialysate production capacity and will likely result in future shortfalls. Currently, the FDA states, “preventing and mitigating shortages of medica