Peritoneal dialysis apparatus and method

Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...

Reexamination Certificate

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Reexamination Certificate

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06290669

ABSTRACT:

The present invention relates to peritoneal dialysis, particularly to apparatus and methods for enhancing the rate of solute removal during peritoneal dialysis.
Peritoneal dialysis (PD) is a medical treatment administered when there is insufficient functioning of the kidneys. It is performed by inserting a sterile plastic catheter into the abdominal cavity of the subject and instilling a dialysis fluid to irrigate the peritoneal chamber such that solutes transfer across the peritoneal membrane into the dialysis fluid from the blood in the mesentery capillary network. This treatment does not require a machine, such as in hemodialysis, but does require much longer periods of time in order to achieve solute removal comparable to that of intermittent hemodialysis. Such a treatment is commonly performed in an ambulatory manner as a CAPD (Continuous Ambulatory Peritoneal Dialysis) treatment.
CAPD is usually performed in four 6-hour sessions during each 24-hour period. In each session, the dialysis fluid is instilled into the peritoneal chamber of the subject and permitted to dwell therein for a period of six hours, following which the dialysis fluid is drained, and a fresh dialysis fluid is instilled. This relatively large number of sessions greatly disturbs the daily routine of the subject. It also increases the risk of infection.
Various studies have been conducted on the application of mechanical vibrations for improving the efficiency of waste removal by PD (peritoneal dialysis); see J.Rudoy et al. Nephron 46:364-366 (1987); Levitt et al. Kidney International, Vol. 35, pp. 1145-1150 (1989); Utsunomia-T et al.,
Nippon-Jinzo-Gakkai-Shi;
1995 Jan; 37(1):24-8; and Japanese Patent Application No. H2-2356561 by H.Aoki filed Sep. 7, 1990 and laid open Apr. 17, 1992, which discloses a peritoneal dialysis system in which low-frequency physical vibrations are applied to the abdomen during dialysis. My prior International Patent Application No. PCT/IL96/00064, filed Jul. 24, 1996 disclosed various appliances which included vibrator devices for applying localized, inwardly directed mechanical vibrations to the abdomen of the subject for this purpose.
An object of the present invention is to provide another type of peritoneal dialysis apparatus which can be used to enhance the rate of solute removal, or which can be used together with the peritoneal dialysis apparatus of my above International Patent Application in order to further enhance the rate of solute removal.
According to a broad aspect of the present invention, there is provided peritoneal dialysis apparatus, comprising a holder device for holding a container of a dialysis fluid to be introduced into the peritoneal chamber of a subject: a peritonial dialysis catheter device constructed to be insertable through the abdominal wall of the subject for introducing the dialysis fluid into the peritoneal chamber and for draining the dialysis fluid therefrom; and a conduit device fluidly connecting a container held by the holder device to the catheter device: characterized in that the apparatus further comprises an agitator located to be cooperable with at least one of said devices for agitating the dialysis fluid in the peritoneal chamber in order to enhance the rate of solute removal therefrom.
It will thus be seen that, whereas the apparatus of the above-identified patent application produced enhanced solute removal by applying mechanical vibrations to the subject's abdomen via an external vibrator, the apparatus of the present invention enhances solute removal by directly agitating the dialysis fluid in the peritoneal chamber of the subject. The apparatus of the present invention may be used in lieu of, but preferrably is used with, that of my above International Patent Application in order to further enhance the rate of solute removal, and thereby to shorten the dialysis periods and/or to reduce the frequency of such periods.
A number of constructions are described below for purposes of example. In some constructions, the agitator is located to be cooperable with the holder device and acts on the container held thereby to agitate the dialysis fluid in the peritoneal chamber; in other constructions, the agitator is cooperable with the conduit device for agitating the dialysis fluid in the peritoneal chamber; and in still other constructions, the agitator is cooperable with the catheter device for agitating the dialysis fluid in the peritoneal chamber.
The invention also provides a method of peritoneal dialysis characterized in providing one of the above-mentioned devices with an agitator for agitating the dialysis fluid in the peritoneal chamber.
Further features and advantages of the invention will be apparent from the description below.


REFERENCES:
patent: 4657160 (1987-04-01), Woods et al.
patent: 5147310 (1992-09-01), Giannini et al.
patent: 5277820 (1994-01-01), Ash
patent: 5336165 (1994-08-01), Twardowski
patent: 5484396 (1996-01-01), Naficy

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