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A DEVICE CONNECTABLE TO A DIALYSIS CATHETHER FOR IN SITU ANALYSIS

Renal dysfunction or failure and, in particular, end-stage renal disease, causes the body to lose the ability to remove water and minerals and excrete harmful metabolites, maintain acid-base balance, and control electrolyte and mineral concentrations within physiological ranges. Toxic uremic waste metabolites including urea, creatinine, uric acid, and phosphorus accumulate in the body’s tissues, which can result in a person’s death if the filtration function of the kidney is not replaced.

Dialysis is commonly used to replace kidney function by removing these waste toxins and excess water. Hemodialysis treatment typically lasts several hours and must be performed under medical supervision three or four times a week, requirements that significantly decrease a patient’s autonomy and quality of life. Also, since hemodialysis is performed periodically instead of continuously, the patient’s condition and general well-being tend to be poor both immediately before hemodialysis (when toxin levels are high) and after hemodialysis (when electrolytes are imbalanced), resulting in the patient having symptoms that range from nausea and vomiting to edema.

Peritoneal dialysis is a common mode of treatment for patients with kidney failure. The technique requires insertion of a peritoneal dialysis catheter to be placed surgically in the abdominal cavity of the patients. This cavity is flushed with a solution with high glucose concentration several times a day. This process is studied by a specialized test, called Peritoneal Equilibration Test (PET). This test requires special preparation and multiple samples. The test necessitates that the patient spend several hours in the peritoneal dialysis unit.

In vivo real time measurement of levels of analytes, such as glucose, creatinine, sodium, potassium, etc. in peritoneal dialysis fluid can enhance physicians’ capabilities to understand the peritoneal membrane characteristics. Development of a device which could be inserted through the existing peritoneal dialysis catheter while maintaining sterility of the circuit and means to continue dialysis while the device is in place, will open a new way to study mechanisms which may potentially modify membrane characteristics.

The idea of real time peritoneal dialysis fluid measurement is likely to open up research into the study of peritoneal membrane function. This technology will open up this new avenue. Patients who are no more suitable for peritoneal dialysis may become candidates to continue peritoneal dialysis if this possibility could be realized. Additionally, patients with preference toward ambulatory peritoneal dialysis may continue to do so if pharmacological agents could be identified to modify the membrane function.

In view of the forgoing, this invention is developed to provide a device that able to measure the level of analytes in vivo real time.

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