Apparatus and method for peritoneal dialysis

Abstract

An apparatus and method for treatment of end stage renal decline and failure through peritoneal dialysis enabling ambulatory transfer of dialysate to and from the peritoneum of a renal patient, this in synthesis and coordination with normal physiological rhythms of the patient. The system remains unobtrusive and less restrictive of patient ambulation and orientation. The present invention includes expendables disposability of which facilitates safe reuse of more expensive portions and is sufficiently simple for use in a home care environment. It may be designed to incorporate real-time, interactive or remote monitoring and regulation and visual or audible indication of system pressures, chemical balances and other important variables.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of Ser. No. 09 / 962,027, filed Sep. 24, 2001, now U.S. Pat. No. ______, which application claims the priority benefit of Provisional Patent Application Ser. No. 60 / 234,681, filed Sep. 22, 2000, for “APPARATUS AND METHOD FOR PERITONEAL DIALYSIS”, the content of both of which are incorporated by this reference.TECHNICAL FIELD [0002] This invention relates to means for treatment of renal decline and failure. It is particularly directed to an improved system for ambulatory transfer of dialysate to and from the peritoneum. BACKGROUND [0003] State of the Art [0004] Medical practice has numerous applications for treatment of impaired renal function and ultimate decline and failure with peritoneal dialysis. The application of peritoneal dialysis, involves introduction of a dialysate solution to the peritoneal cavity outside the omentum, through an indwelling single lumen catheter entering the peritoneum through t...

AI Technical Summary

Benefits of technology

[0017] This novel system enables coordination of fluid transfers and dialysis processes with ambient physiological activity of the patient. Balance in physiological dynamics is enhanced with a more effective delivery and monitoring system that follows natural rhythms. A system of indicators may communicate various therapeutic variables and physiological measurements, for example, urea, presence of air, temperatures and electrolytes in the dialysate. Accordingly, the indicator system results in reduction of incidence of peritonitis, potentially resulting in cost savings and because it is more efficient in determining the parameters of the dialysate thereby improving timing and fluid exchange. Such fine tuning of physiological balances enhances the physician's and patient's ability to determine optimal dynamic dosage, regime and protocol for the benefit of the patient, irrespective of physical orientation of the patient or of the treatment system or of both. The system entails a small portable pump, filter system, receptacle, with improvements comprising a dialyzing fluid bag designed to be worn, which may alternatively simply be hung from an IV stand for gravity flow where preferably, a novel vest for low profile, aesthetically appealing, symmetric and unobtrusive system containment and placement, and indicators whereby fluid flow rates, volume, timing, direction, pulsating patterns and dialysate and bodily electrolytes, urea, protein, acid-base balances as examples may be monitored and regulated. The system comprising these improvements is inexpensive, disposable and sufficiently simple for use in a home care environment and may be equipped with a real-time monitor and indicator of various system conditions, dialysate parameters and other important therapeutic variables.

[0021] Indicator means may also be included whereby at least one therapeutic variable, but potentially any of a plurality of therapeutic or diagnostic variables, may be monitored or regulated to determine and establish optimal dynamic dosage or optimal dynamic regime or optimal dynamic protocol, or any or all of the foregoing. Such optimal dynamics enable achievement of a desired therapeutic balance. The indicator means may further enable detection of achievement of the desired therapeutic balance. Such therapeutic variables may be monitored or regulated selectively automatically or by direct intervention and may be monitored or regulated from a source remote from the patient. These therapeutic variables may comprise, alone or in combination, dialysate temperature or dialysate flow volume or dialysate flow direction or dialysate flow timing or dialysate chemistry including, for example, albumen, urea, uric acid, creatinine, creatine, pH, ions or electrolytes. The therapeutic variables may be monitored or regulated with detection structure positioned in any of a variety of locations including without limitation associated with the conduit or the pump or the receptacle system or any combination of the foregoing. The detection structure may be located proximal to or within the body of the patient and thus may further monitor and regulate the variables of body temperature or residual pressure or blood content of the patient.

[0023] Accordingly, the present invention contemplates a method of performing peritoneal dialysis, comprising selection of the above characterized device system for treatment of renal decline or failure; association of said device system with an indwelling dialysis catheter such that substantially all of an amount of exhausted dialysate within a peritoneum of a patient may be removed to be disposed of or processed for recycling; and infusion of a therapeutic volume of unused or recycled dialysate optimal for treatment of the patient.

[0024] In accordance with this method a selected volume of unused dialysate, which is in excess of the therapeutic volume and is sufficient to accomplish dialysis through an extended period of time during which the patient may be in a sleeping condition, may selectively be introduced to the peritoneum of the patient. This method may incorporate the distention-limiting structure within or around the receptacle system, may accommodate simultaneous or sequential passage or reciprocal circulation of exhausted and unused or recycled dialysate, either of which may be in a pulsating flow pattern, and may involve having the exhausted dialysate undergo a process that extends its useful life such as, alone or in combination, filtration or chemical, electrical, thermal or light modification.

Problems solved by technology

Most devices require the patient to be tethered and confined and to be situated at a fixed location with a dialyzing bag hanging from an IV stand for gravity feed throughout the transfer of dialysate to and from the peritoneum of the patient and do not permit ambulation during transfer of dialysate.

Some systems utilize pumps that have the disadvantages of substantial cost, size and weight that are prohibitive of significant ambulation during dialysate transfer.

Irrespective of which paradigm has been used, heretofore, peritoneal dialysis procedures presuppose introduction and maintenance of a total of approximately three liters or twelve pounds of dialysate solution to and within the peritoneum for an extended period of time for the patient, with the epithelial tissues of the peritoneum acting essentially as an artificial kidney; the process uncomfortably expands and distends the abdomen of the patient and results in discomfort, disfigurement, flatulence and inconvenience.

Prior art devices for containment of dialysate bags for gravity flow have heretofore been available exclusively for attachment to IV stands adjacent to the patient's person, precluding comfort in movement such as standing, walking or other ambulation and other positions and activities and, further also, detracting from the aesthetic appeal to the patient and diminishment of the patient's body balance and self-image.

A related disadvantage of prior art peritoneal dialysis is the deleterious effect on surrounding epithelial tissues from extended exposure to dialysate that is saturated with caustic bodily toxins.

Heretofore, inefficiencies have resulted from infusion of excessive or insufficient amounts of dialysate relative to the needs of the particular patient during a particular time frame.

Similarly, dialysate infused in ideal amounts but incorrectly presumed to be exhausted is occasionally discarded prematurely.

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