Nephros Inc.

Edward C Spence

Gregory R Collins

James Summerton

A method and an apparatus are provided for preventing retrograde flow of fluid, e.g., blood products, into a source of sterile substitution fluid (). The apparatus of the present invention includes a controllable pinch valve member () that is placed on a section of a conduit () which carries sterile substitution fluid to an extracorporeal circuit (). In one embodiment, control over the valve member () is based on a control unit () using fluid pressures that are sensed upstream and downstream of the valve member () by upstream sensor () and downstream pressure () respectively. The valve member () is preferably opened only when the upstream pressure is greater than the downstream pressure. This assures that the substitution fluid flows only in a single direction when the pinch valve member () completely occludes the conduit () when in a closed position. Therefor, blood will not contaminate the sterile fluid by being drawn into the conduit () due to pressure differences.

Valve mechanism for infusion fluid systems

A hemodiafiltration/hemofiltration cartridge is preferably formed of a single cartridge providing multi-stage hemofiltration and hemodiafiltration defined by a first hemodiafiltration stage having first filtering elements and a second hemofiltration stage having second filtering elements. Both stages are contained in a single cartridge. The cartridge can be used in a mid-dilution scheme, a pre-dilution scheme or a post-dilution scheme.

Hemodiafiltration/hemofiltration cartridges

An apparatus and method are provided for generating sterile infusion fluid from non-sterile infusion fluid produced by a machine. In one embodiment, the sterile infusion fluid is produced by a sterile fluid generating device that is an ancillary device designed to operate in conjunction with the existing machine. For example, the sterile fluid generating device is used in conjunction with a dialysis machine according to one embodiment resulting in sterile infusion fluid being produced.

Method and apparatus for generating a sterile infusion fluid

In a blood dialysis system including a source of substitution fluid () and a blood dialysis machine, a hemodiafiltration system having a first dialyzer () including a first blood compartment () having a first blood inlet which receives blood to be cleaned and a first blood outlet which discharges partially diafiltered blood and a first dialysate compartment () having a first dialysate inlet and a first dialysate outlet, means () for mixing the partially diafiltered blood with substitution fluid from the source to obtain a blood/substitution fluid mixture, and a second hemofilter () including a second blood compartment () having a second blood inlet which receives the blood/substitution fluid mixture and a second blood outlet which discharges filtered blood and a second permeate compartment () having a second permeate outlet.

Multistage hemodiafiltration/hemofiltration method and apparatus

A dual-stage system and methods for using the same include first and second filtration cartridges is provided and is particularly suited for hemodiafiltration and/or hemodialysis. As fluid enters the first filtration cartridge, the hydroxyl ion concentration and hence pH is increased by exposing it to either a strong base or a salt of a weak acid across a filter membrane. This stage allows for improved removal of certain toxins in the fluid, such as protein-bound substances that disassociate more readily from proteins at higher pH. As the filtered fluid enters the second filtration cartridge, the pH of the fluid is restored to normal levels prior to infusion to a patient.

Ionic enhanced dialysis/diafiltration system

This invention provides a method and apparatus for a hemodiafiltration delivery module that is used in conjunction with a UF controlled dialysis machine to enable hemodiafiltration therapy to be performed. The advantage is that one can fully utilize a current functioning dialysis machine to perform a hemodiafiltration therapy as opposed to purchasing a completely new machine that offers this capability.

Method and apparatus for a hemodiafiltration delivery module

A dual-stage system and methods for using the same include first and second filtration cartridges is provided and is particularly suited for hemodiafiltration and/or hemodialysis. As fluid enters the first diafiltration cartridge, the hydrogenion concentration (pH) is reduced by exposing it to an acidic solution such as citric acid across a filter membrane. This stage allows for improved removal of certain toxins in the fluid, such as protein-bound substances that disassociate more readily from proteins at lower pH. As the filtered fluid enters the second filtration cartridge, the pH of the fluid is restored to normal levels prior to infusion to a patient.

A dual-stage filtration cartridge is provided. The cartridge can be embodied as a mid-dilution hemodiafiltration cartridge or a redundant sterilization filtration cartridge. The cartridge includes a housing having a first end and an opposing second end. The housing has a primary fluid inlet and outlet at the first end of the cartridge. The housing also defines first and second filtration stages with the first filtration stage including first filtering elements disposed between the first and second ends of the housing. Each stage has a separate inter-lumen fiber space, but shares a common extra-lumen space. The primary fluid inlet communicates with the first filtering elements at the first end so that fluid flows through the first filtering elements toward the second end. The second filtration stage includes second filtering elements disposed between the first and second ends of the housing with the fluid outlet communicating with the second filtering elements at the first end.

Dual-stage filtration cartridge

The present invention provides a hemodialysis or hemodiafiltration system and method using two dialyzer stages (122, 138), wherein the temperature of a dialysate fluid stream of the first cartridge (122) is increased such that the blood in the first cartridge (122) is dialyzed or diafiltered at an elevated temperature, while blood in the second cartridge (138) is dialyzed or diafiltered against a dialysate stream at normal blood temperature. This results in an increased solute diffusivity and a corresponding increase in removal of blood substances by diffusion. When diafiltration is performed, an additional removal of substances occurs by convection as a larger portion of plasma water from a blood compartment (142) can be filtered across a semi-permeable membrance (140) at the same transmembrane pressure due to the reduced viscosity of the heated blood and plasma water.

Thermally enhanced dialysis/diafiltration system

A method of hemodiafiltration including the steps of supplying a blood inflow, diafiltering the blood inflow using a first non-isosmotic dialysate fluid to provide a partially diafiltered blood outflow, mixing the partially diafiltered blood outflow with a substitution fluid to provide a blood/substitution fluid mixture, and diafiltering the blood/substitution fluid mixture using a second non-isosmotic dialysate fluid.

Non-isosmotic diafiltration system

In a blood dialysis system including a source of substitution fluid and a blood dialysis machine, a hemodiafiltration system comprises a first dialyzer including a first blood compartment having a first blood inlet which receives blood to be cleaned and a first blood outlet which expels partially diafiltered blood and a first dialysate compartment having a first dialysate inlet and a first dialysate outlet, means for mixing the partially diafiltered blood with substitution fluid from the source to obtain a blood/substitution fluid mixture, and a second dialyzer including a second blood compartment having a second blood inlet which receives the blood/substitution fluid mixture and a second blood outlet which expels diafiltered blood and a second dialysate compartment having a second dialysate inlet and a second dialysate outlet.

Two stage diafiltration method and apparatus

An apparatus and method for hemodiafiltration are disclosed. The apparatus includes a first dialyzer cartridge containing a semi-permeable membrane that divides the dialyzer into a blood compartment and a dialysate compartment. Fluid discharged from the blood compartment of the first dialyzer cartridge is mixed with sterile substitution fluid to form a fluid mixture and the mixture enters a second dialyzer cartridge. The second dialyzer cartridge contains a second semi-permeable membrane which divides the second dialyzer cartridge into a blood compartment and a dialysate compartment. Hemodiafiltration occurs in both cartridges.

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Bronx, NY, United States of America

Edward C Spence