Automated Peritoneal Dialysis Device

Abstract

An automated peritoneal dialysis (APD) system using gravity to deliver fluid from one or more source dialysate bags to the patient as the destination, and using gravity to deliver fluid from the source patient to the destination drain container or drain receptacle, and heats at least one dialysate bag placed onto a heated plate, and using a disposable tubing set is used for dialysate delivery to and from the patient, and using one or more solenoid-operated, normally closed, electronically-controlled pinch valves which pinch or release the disposable tubing set's tubing to stop or start fluid flow, respectively.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application incorporates by reference and claims the benefit of priority to U.S. Provisional Application No. 62 / 807,121 filed on Feb. 18, 2019.BACKGROUND OF THE DESCRIPTION[0002]The present subject matter relates generally to automated peritoneal dialysis (APD) devices, and potentially may be applied to other medical device applications as well, including hemodialysis applications.[0003]Peritoneal dialysis (PD) consists of a series of cycles of filling, dwelling, and draining dialysate solution into and out of a patient's peritoneal cavity in their lower abdomen for patients with End Stage Renal Disease (ESRD). The solution is exchanged by connecting one or more dialysate solution bag(s) and associated disposable tubing to a transfer set with a shutoff pinch valve, which in turn connects to a PD catheter surgically implanted in the patient's abdomen as shown in FIG. 5. PD dialysate solution contains dextrose, icodextrin (i.e., starch...

AI Technical Summary

Benefits of technology

The present patent provides solutions to common problems in peritoneal dialysis, such as peritonitis, pumping devices, cassettes, loading tubing sets, horizontal device footprint, noise, dialysate bag lifting, connecting the proper bag concentration, low flow rates, therapy efficacy, portability, drain containers, and therapy programming. The improved automated peritoneal dialysis device is cost-effective and designed for easy disposables setup and prevention of unnecessary injuries.

Problems solved by technology

Today, active pumping APD devices are expensive, with significant costs associated with the pump, valves, pressure sensors, and / or pneumatic manifolds, along with significant costs associated with the disposable tubing sets with cassettes to interface with said APD devices.

Additionally, excessive delivery and / or suction pressures causes inflow or outflow pain during filling or draining phases for many patients.

Today, active pumping APD devices' disposable tubing sets with cassettes are expensive.

Some cassettes may require expensive ultrasonic welding or other technology to bond a rigid plastic cassette with a flexible thin plastic sheeting membrane, with costly high scrap rates associated with failed sheeting bonds.

A common, serious complication of APD therapy is peritonitis.

Peritonitis can occur if a patient touches the fluid path of their disposable tubing set and / or solution bag access port, resulting in touch contamination.

Touch contamination can introduce bacteria or other contaminants into the sterile fluid path, thus causing an infection or inflammation of the peritoneum, known as peritonitis.

However, there are no shrouded female Luer fittings which mate to the dialysate bags' shrouded male Luer fittings.

An APD device's disposable tubing set without a cassette poses a potential problem with the user loading the tubing into the hardware enclosure in the reverse orientation.

For gravity-based devices, portability poses a problem since the machines tend to be rather tall in their therapy operational position.

Free flow of fluid from an APD device resulting in unintended Increased Intraperitoneal Volume (IIPV) can be fatal to patients.

Conventionally, APD devices are often audibly noisy during operation.

They are also prone to fluid ingress.

Conventionally dialysate bags are often difficult to lift up to place them in the proper position required for therapy.

In addition, the peritoneal dialysis patient population tends to skew older and more frail than the general population, thus exacerbating these potential lifting difficulties.

Lifting heavy dialysate bags may cause shoulder or back problems, may lead to the user losing balance and / or falling over.

These same difficulties may be experienced by caregivers who may perform setup rather than the patients themselves.

Additionally, patients and caregivers in certain regions in the globe and / or female patients may have smaller statures and may not have as much strength as others.

Additionally, many PD patients also suffer from other comorbidities or illnesses such as diabetes mellitus, which may further reduce the patient's ability to lift heavy objects.

Existing APD devices do not provide any sort of mechanical advantage nor any other active or passive features to assist patients or caregivers in lifting heavy bags to the proper height required to perform APD therapy.

As such, some physicians may be hesitant to prescribe APD therapy to a patient they believe may not possess the strength to lift the bags into place.

Those patients may be forced to perform hemodialysis instead, which may not be the preferred dialysis modality for those patients.

However, several smaller bags are more expensive to manufacture than fewer larger bags.

APD patients and / or their caregivers may be illiterate or have low literacy.

They may not be able to read text-based prompts to properly set up, monitor, tear down, or troubleshoot their APD therapy.

This will either result in a longer therapy duration or less effective therapeutic outcomes.

If it takes longer to fill due to suboptimal dialysate bag head height, then there may be less time available for dwelling.

Therefore, therapy is less effective if low flow rates result in less dwell time, for a given (e.g. 8 hour) total therapy time.

Alternatively, low flow rates could lead to longer total therapy duration, which is not desirable since patients' lives are disrupted with therapy durations that exceed the patient's normal nocturnal sleep duration.

In some locations, AC power outages are a frequent occurrence, each potentially lasting several hours.

Other locations may have frequent, short duration AC power outages and / or brownouts, each lasting a few seconds or several minutes.

Additionally, if patients want to start therapy in one room within their home while performing some activity (e.g. watching TV, cooking, studying, etc), followed by movement to their bedroom to complete therapy, there may not be AC plugs readily available in all of the locations within the home that patients may find themselves wanting to perform some or all of their APD therapy.

To date, no commercially available APD device is able to continue delivering therapy during an AC power outage.

Currently, none of the widely available, inexpensive pinch valves are capable of opening the pincher jaws if a tube is not already installed in the valve, using the manufacturer's recommended voltage.

Additionally, APD users may have difficulty draining the relatively large fluid volumes that may be stored in one or more reusable or disposable drain containers if the drain containers do not contain features to facilitate easy drainage.

Users may not know which method they need to use, which could result in selecting the wrong programming method, attempting to enter their prescribed parameters, only to later realize the user interface doesn't have the programmable option(s) they need, thus resulting in the user backing out from the programming menu and trying to program the prescription again using the alternate programming method.

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