Aksys Gmbh

Akysys, Ltd.

Baxter Healthcare Sa

Dennis M Treu

Rodney S Kenley

Dawn Matthews

Frederick H Peter, Jr

Kenneth E Pawlak

Thomas M Feldsein

Wayne F Adolf

Douglas L Wilkerson

Shawn O Barrett

Tom L Brose

Lori A Plummer

Thomas M Feldsien

William C Cesaroni

Jack B Hough

Dilip H Shah

Anthony M Anello

Michael Edward Wiklund

Joel DeJesus

Andrew Gebhardt

Steven J Wroblewski

Russel L Sage

William R Dolan

Michael D Peters

Russell L Sage

Christine F Schroeder

Michael Duch

Seema A Kapadia

H Gordon Minns

Linda Roettger

A user interface for a medical instrument such as a dialysis machine is described which uses both a touch screen and at least one hard key off of the touch screen to effectuate a change in a parameter associated with the operation of the machine or the treatment session. The user interface is connected to a central computer control system having a host microprocessor and a backup safety microprocessor. The hard key is directly wired to the safety microprocessor. After the user selects a new parametric value on the touch screen, the user presses a hard key. The host and safety microprocessors implement a verification routine to insure that the entered parameter is appropriate for the patient's treatment and the display on the touch screen. If the verification procedure ends in a positive result, the user is prompted to presses a second hard key to confirm the change, causing an additional verification check to be preformed. If the additional verification check is successful, the parametric value is entered into a memory (such as a hard disk) storing instructions for operation of the medical instrument.

User interface and method for control of medical instruments, such as

Several tests are described for verifying the integrity of the extracorporeal circuit of a medical instrument, such as a dialysis machine. One test verifies the condition of the blood tubing set. Another test verifies that the clamps in the arterial and venous lines adequately occlude the arterial and venous lines. Another test confirms that the arterial and venous lines are properly installed on their respective ports for receiving the lines after the treatment session has ended. In this last test, a fluid such as heated water is then introduced into one of the arterial or venous lines and sent out of the line through its respective port, where it is detected with suitable fluid detection equipment such as a thermistor. The heated fluid and thermistor verify that the arterial line is connected to its arterial port and the venous line is connected to its venous port and that there is an unobstructed fluid path in the blood tubing set. If the lines are installed on the wrong port, the user is prompted to correctly install the arterial and venous lines on their respective ports.

Blood tubing set integrity tests for extracorporeal circuits

A user interface for a medical instrument such as a dialysis machine is described which uses both a touch screen and at least one hard key off of the touch screen to effectuate a change in a parameter associated with the operation of the machine or the treatment session. The user interface is connected to a central computer control system having a host microprocessor and a backup safety microprocessor. The hard key is directly wired to the safety microprocessor. After the user selects a new parametric value on the touch screen, the user presses a hard key. The host and safety microprocessors implement a verification routine to insure that the entered parameter is appropriate for the patient's treatment and the display on the touch screen. If the verification procedure ends in a positive result, the user is prompted to presses a second hard key to confirm the change, causing an additional verification check to be performed. If the additional verification check is successful, the parametric value is entered into a memory (such as a hard disk) storing instructions for operation of the medical instrument.

A vessel for containing a batch quantity of chemicals for preparation of physiologic, therapeutic, or irrigation solutions, such as dialysate. The vessel has a cap and a bottle shell having features that make the vessel suitable for mounting to an apparatus for automatically opening the vessel. In a preferred embodiment, the cap has a frangible membrane sealing the vessel. A protective overcap is removable mounted to the cap to protect the cap from puncture prior to installation on the opening apparatus.

Vessel for containing batch quantities of dialysate or other physiologic

A dialysis machine is described which has a batch dialysate preparation system comprising a lightweight, substantially noncompliant dialysate tank and volumetrically closed dialysate circuit. The tank is made from a polymeric material, such as polypropylene, with fiberglass windings on the exterior of the tank. The noncompliance of the tank and dialysate circuit allows for greater control over ultrafiltration of the patient.

Lightweight noncompliant dialysate solution tank for batch dialysate

Chemical vessel

Dialysis machine

Water treatment and pretreatment methods and processes for use in a dialysate preparation machine are described. In one aspect, water is passed through a first filter having chlorine removal properties and then passed into a line. Water is removed from the line at a sample location. The removed water is periodically sampled for the presence of chlorine or chloramines. The presence of chlorine or chloramines indicates that the filtration capacity for chlorine of the first filter is substantially exhausted. The method further includes the step of filtering the water downstream from the sample location in a second filter having chlorine removal properties, and replacing the first filter if chlorine or chlorine is detected during the sampling step. Water pretreatment may be provided by mixing hot and cold water from a source with a temperature-controlled mixing valve and passing the water through the first filter, so as to provide warm, filtered water to the dialysate preparation machine.

Water treatment for dialysate preparation

Methods and apparatus for increasing the accuracy of ultrafiltration in a dialysis machine and decreasing the time required for dialysis. The machine inclused a substantially non-compliant tank for mixing and storing a batch of dialsyate. In a preferred form, the tank is a hollow vessel made from a lightweight and chemically inert material, such as polypropylene, reinforced on its exterior. The machine further includes an ultrafiltration pump for pumping fluid from an extracorporeal circuit to an ultrafiltration tank commensurate with the removal of water from the patient. The pump is calibrated with the volume of fluid in the tank. The reduction in the time to conduct hemodialysis of the patient is achieved by introducing the patient's blood into the arterial line and conducting the blood to the blood pump, measuring the pressure of the blood in the arterial line, increasing the pump rate of the blood pump, and in the event that the pressure measured in the arterial line drops below a predetermined threshold value, slowing the pump rate of the blood pump.

Methods for ultrafiltration control in hemodialysis

A hemodialysis machine has ports of a disinfection manifold for receiving the arterial and venous line connectors terminating the arterial and venous lines. The ports are in fluid communication with a hydraulic system that circulates disinfection fluid through the machine including the extracorporeal circuit. The ports are constructed so as to provide a gap extending circumferentially around the arterial and venous line connectors. When the disinfection fluid circulates through the ports of the disinfection manifold, the fluid circulates around the external surfaces of the connectors as well as through the internal fluid passages, thereby insuring a complete disinfection of the connectors.

Disinfection of arterial and venous line connectors hemodialysis machine

A connector for a tube and a port construction for sealingly and securely receiving the connector. The connector has a male luer comprising a locking hub and a cylindrical tubing port. The cylindrical tubing port receives the free end of the tube. A second piece is provided that envelops the male luer, comprising a elongate cylindrical housing having a interior surface. The male luer and the tube are snugly inserted within the interior surface of the second piece to form a unitary connector. The port receives the connector and has a housing having a first end and a second end and an open interior region defining first and second chambers and a housing axis. The first and second chambers are disposed within the first and second ends of the housing, respectively. A locking knob is movably mounted on the first end of the port apparatus and movable along the housing axis relative to the first end between first and second positions. The knob is rotatable in the second position relative to the first end into a locking engagement with the housing. When the connector is inserted into the first chamber of the port, the user rotates the knob to one side to securely retain the connector. The connector is pressed into sealing contact with an O-ring disposed in the interior region of the first chamber, thereby preventing any leakage around the connector and port. Various alternative tubing connectors are disclosed.

Tubing connectors and parts for receiving the connectors

An apparatus is described for automatically opening and dispensing the contents of a vessel, for example, a vessel containing dialysate chemicals for dispersion into a dialysate preparation tank. The apparatus comprises a housing having an open interior region, with the vessel mounted above the housing, and a spike reciprocable within the interior of the housing between upper and lower positions. The spike pierces the vessel when the spike is moved to the upper position. The spike has an upper spike element that pierces the bottle and an integral spike body concentric with the housing permitting passage of dialysate chemicals therethrough after the spike has pierced the vessel. A drive means is proved for moving the spike relative to the housing between the upper and lower positions, so as to control the operation of the spike and the automatic release of the contents of the vessel.

Apparatus for opening a vessel

A loading platform and chemical addition system are described for a machine that prepares a batch of dialysate. The loading platform is in fluid communication with a dialysate preparation tank, and receives chemical vessels that contain a batch quantity of dialysate chemicals. The chemicals are released from the vessels automatically and fall onto a shelf in the loading platform. Nozzles and spray equipment are provided for insuring the complete release of the chemicals from the vessels and their dispersion into the tank. Novel mixing techniques are implemented in the tank to insure complete mixing of the dialysate solution and prevention of settling of dialysate solution at the bottom of the tank.

Apparatus for supplying a batch of chemicals to a dialysate tank

A method is described herein for automatically rinsing blood back to a patient. The method comprises the steps of pumping dialysate (or, alternatively, saline solution) through a dialyzer into an extracorporeal circuit, and pumping blood in the extracorporeal circuit out the arterial and venous lines back to the patient. Optical sensors monitor the concentration of blood in the arterial and venous lines as the blood is being pumped from the extracorporeal circuit back to the patient. The return flow of blood is ceased when the concentration of blood in the arterial and venous lines drops to a predetermined threshold level, thereby preventing excess fluids from being returned to the patient.

Method of rinsing back blood to hemodialysis patient

A dialysis machine is described which provides for the detection of leakage anywhere in the machine. The machine includes integral water treatment, dialysate preparation and extracorporeal circuit modules. The floor of the machine is constructed in a non-horizontal manner so as to provide a fluid catchment chamber with a fluid sensor. The extracorporeal circuit is mounted above the dialysate preparation module and the water treatment module. In one embodiment, a drain and drain tube allows fluid that leaks from the extracorporeal circuit module to be conducted to the floor of the machine, where the leak can be detected, along with a fluid leak in the water treatment or dialysate preparation modules. In another embodiment, a separate fluid leakage detector is placed at the base of the extracorporeal circuit module for detection of leakage in situ in the extracorporeal circuit, while the catchment chamber and sensor in the base of the machine detect leaks from the other modules.

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Gurnee, IL, United States of America

Dennis M Treu