Automated peritoneal dialysis system and process with...

Details Automated peritoneal dialysis system and process with... Automated peritoneal dialysis system and process with...

2002-02-14

2004-07-06

Drodge, Joseph (Department: 1723)

Liquid purification or separation

Processes

Liquid/liquid solvent or colloidal extraction or diffusing...

C073S038000, C073S040000, C210S085000, C210S090000, C210S257200, C210S321690, C210S739000, C210S741000, C604S029000, C604S065000

Reexamination Certificate

active

06758975

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to an automated peritoneal dialysis system and process that provides a large supply of proportioned dialysis fluid which is used in a peritoneal dialysis system and process wherein the dialysis fluid is sterilized in-line with integrity checks in realtime during dialysis before delivery to a patient's peritoneal cavity.
BACKGROUND OF THE INVENTION
The National Institute of Health (NIH) reports that more than 289 people per million population in the United States require renal replacement therapy in the form of dialysis. The main barriers to treating dialysis patients have been expense and practicality. Moreover, the largest portions of the world's population live in countries that do not support dialysis. Patients in those areas who need dialysis must pay for their own treatment, which leads to a sparing use of material that results in serious under dialysis and ineffective treatment. In the United States, the need for the patient to drive to a dialysis center for treatment, often over long distances, is a serious barrier to obtaining dialysis treatment for some needy patients. It is rather impossible to provide in-center dialysis to patients who cannot get to the clinic. Furthermore, in countries where there are few dialysis patients there is no highly trained and dedicated staff to care for the patients' special needs. In short, the high cost of the current dialysis methods, massive supplies that must be delivered and stored for home dialysis, inadequate transportation, and a lack of trained professional healthcare workers capable of delivering dialysis treatment, are serious obstacles for dialysis patients.
There are two methods of clinical dialysis in widespread use today. They are called hemodialysis and peritoneal dialysis. They differ in the method by which the patient's blood is exposed to the dialysate. Hemodialysis is the most widely used type of clinical dialysis. In this method, the patient's blood is taken outside the body and passed through a dialysis cell, called a hemodialyzer. The hemodialyzer includes a membrane. The patient's blood flows on a sterile side of the membrane while the dialysate flows along the opposite side. Dialysis of blood toxins and excess water occurs across the membrane. U.S. Pat. Nos. 5,683,584 and 6,074,559 disclose typical blood filters for use in hemodialysis to filter blood. This process requires the assistance of trained personnel and subjects the patient to life threatening dangers of mechanical malfunction, rapid shifts of fluid and metabolite, and surgery associated with attaching an artery directly to a vein to produce an adequate blood flow for dialysis treatment. Hemodialysis removes excess fluid from a patient by a process called ultrafiltration, which uses hydrostatic pressure to force water out of the blood, across the hemodialyzer, and into the dialysate for removal. It is also known to reuse blood filters after hemodialysis and to test the filter membrane when it is fully wetted with an aqueous solution using pressurized air to determine if there is a leak in the filter membrane, such as disclosed in U.S. Pat. No. 5,808,181.
Peritoneal dialysis was developed as a means of surmounting some of the difficulties associated with in-center hemodialysis. In addition, peritoneal dialysis is more suitable for in home use. In peritoneal dialysis, a specially prepared, sterilized dialysis fluid (dialysate) is instilled into the peritoneal cavity through an in-dwelling dialysis catheter. The toxins move down the gradient and into the dialysate, freeing the body of toxins. The dialysate is allowed to remain in the peritoneal space for a period, commonly called the dwell time, in order to maximize the quantity of toxins removed per unit volume of dialysate. Then, after absorbing body toxins in a long slow process, the dialysis fluid is removed and discarded. The longer the fluid remains in the cavity the less effective it becomes at removing waste due to the shift in the gradient towards equilibrium. The process is then repeated until the level of toxic metabolites in the blood is reduced to a desired level. This method is commonly referred to as the “intermittent” or “batch” method due to the fact that multiple one or two liter bags of fresh, sterilized dialysis solution must be constantly exchanged to provide the supply of fresh, sterilized dialysate with an acceptable osmotic gradient. Peritoneal dialysis uses an osmotic gradient that is created by adding an osmol, usually glucose, to the dialysate to remove the patient's excess fluid.
Commercially available, pre-sterilized peritoneal dialysate is expensive. Most patients have a peritoneal dialysis prescription of ten to fifteen liters per session, five to six times a week. However, this volume of fluid is frequently inadequate for the patient's need but is all the patient can afford. The home peritoneal patient must have a large storage space in which to put the dialysis solution he will need until the next monthly shipment. On average, they must have the capacity to store about seventy-five to ninety gallons of dialysate to last the month. In addition, the patients must keep on hand a supply of other dialysis solutions with different glucose levels to meet changing body conditions.
Infection is one of the greatest dangers of peritoneal dialysis, either at home or in the hospital. Each time a sterile seal is broken, there is the danger of introducing bacteria into the system. Thus, each time a patient inserts a tube in a bag of fluid, or connects the tubing to his own in-dwelling catheter, or attaches the drainage bag, or does anything else which opens the system, there is the potential for contaminating the system and threatening the life of the patient. The more times the system must be opened, the greater the danger of contamination. The danger is actually compounded by fatigue, physical incapacity, and carelessness. The more often the patient must open the system, the less careful he becomes with each instance.
To overcome the above problems, various automated processes and systems for peritoneal dialysis have been proposed which seek to overcome the problems associated with the “batch” method of peritoneal analysis. For example, U.S. Pat. Nos, 4,586,920, 4,718,890, 4,747,822, 5,004,459, and 5,643,201, issued to the present inventor, all relate to continuous or cyclic peritoneal dialysis systems and processes for overcoming the problems associated with effective home dialysis for needy patients. U.S. Pat. Nos. 4,586,920, 4,718,890, and 4,747,882 disclose single and double catheter peritoneal dialysis systems and methods which are automated in a continuous and cyclic manner. A reverse osmosis unit in combination with various filters produces sterilized water which is mixed with a dialysate in a conventional proportioning machine to produce a properly mixed dialysis solution. The dialysis solution is delivered through a high volume bacterial filter which sterilizes the dialysis solution. The sterilized dialysis solution is then stored in a head vessel for use in subsequent dialysis process. To test for sterilization, the dialysis solution may be cultured in the head vessel to see if a bacteria grows. U.S. Pat. No. 5,004,459 discloses an automated cyclic peritoneal dialysis system and process which automatically adjusts the osmoality of the dialysis fluid in response to the amount of excess fluid removed from the patent. Sterilized dialysis fluid is provided by mixing sterilized water and dialysate concentrate in a sterilized preparation unit. The dialysis preparation unit is disposed upstream of the dialysis machine which has been pre-sterilized with bleach or the like. U.S. Pat. No. 5,643,201 discloses an automated cyclictidal peritoneal dialysis system and process having a reverse osmosis unit for sterilizing water with a concentrate dialysate to produce a proportioned dialysis solution whereupon the dialysis solution is further sterilized by heating, and stored in a reservoir before use in the

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