Surgery – Cardiac augmentation
Reexamination Certificate
1998-10-02
2001-02-06
Kamm, William (Department: 3737)
Surgery
Cardiac augmentation
Reexamination Certificate
active
06183412
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to pump control systems and, more specifically, to a pump control system for an implantable blood pump.
2. Description of Related Art
Implantable blood pump systems are generally employed either to completely replace a human heart that is not functioning properly, or to boost blood circulation in patients whose heart still functions but is not pumping blood at an adequate rate. Known implantable blood pump systems are primarily used as a “bridge to transplant.” In other words, existing blood pump system applications are mainly temporary fixes, intended to keep a patient alive until a donor is available. However, the shortage of human organ donors, coupled with improvements in blood pump reliability make long-term, or even permanent blood pump implementations a reality. The estimated need for a relatively simple, long-term ventricle assist device (VAD) is presently projected at between 50,000 and 100,000 patients per year in the United States alone.
Despite this need, existing implantable pump systems have not been satisfactory for long term use. Known systems of the continuous flow type are designed primarily for use in a hospital setting. These systems typically include the implanted pump device, a power source such as a rechargeable battery, a motor controller for operating the pump motor, and an external operator console. While some existing implantable pump systems allow for operation while decoupled from the operator console, operating these systems “stand-alone” can be a risky endeavor. This is due, at least in part, to the lack of an adequate user interface when the system is decoupled from the console.
Prior art blood pump systems generally only include electronics for operating the pump when disconnected from the console. Often, the user interface is limited to a green light indicating that the system is operating, or a red light indicating that the system is not operating properly. There are no provisions for displaying system parameters, diagnostic messages, alarm messages, etc. Further, known systems typically lack memory capabilities. Hence, when a technician attempts to diagnose a prior art blood pump system after the red light indicated a system failure, there is no record of the system conditions related to the failure.
Further, even when an implantable continuous flow pump is coupled to an operator console, relevant system parameters are missing. For example, the operator consoles of known continuous flow pump systems may monitor pump parameters such as voltage level, current level, pump speed, etc. These parameters, however, do not provide all the necessary information to properly monitor a system that is as complicated as the human circulatory system. The system can be better assessed if pump parameters are analyzed in conjunction with other factors, such as blood flow rate, blood pressure or vibro-acoustic signatures. It is even more desirable to monitor all of these parameters together in real time. Unfortunately, known blood pump systems typically lack the ability to integrally analyze these data in real time.
Moreover, prior blood pump systems are not conducive to long-term use outside an institutional setting. As discussed above, known systems require a large, fixed operator console for the system to function. While prior art operator consoles may be cart mounted to be wheeled about the hospital, at home use of known systems is difficult at best.
Other problems of prior pump systems that have limited their mobility and use to relatively short times are related to motor controller size and shape limitations necessary for convenient mobility, weight limitations for implantation to avoid tearing of implant grafts due to inertia of sudden movement, high power consumption that requires a larger power supply, complex Hall Effect sensors/electronics for rotary control, the substantial desire for minimizing percutaneous (through the skin) insertions, including support lines and tubes, and high cost effectively.
Thus, there is a need for an implantable pump control system that addresses the shortcomings associated with the prior art.
SUMMARY OF THE INVENTION
A controller module for an implantable pump system which includes a pump having an electric motor is presented in one aspect of the present invention. The controller module includes a microprocessor, a motor controller electrically coupled to the microprocessor and adapted to power the pump motor such that the pump motor operates at a desired speed. The motor controller outputs digital representations of the pump motor operating parameters to the microprocessor. A first memory device is coupled to the microprocessor for storing the digital signals representing the pump motor operating parameters. The controller module further includes a user interface. In one embodiment, the user interface includes an LCD display and a keypad. In a further embodiment, a rechargeable battery is included for powering the controller module.
In another aspect of the present invention, a data acquisition system includes a primary power supply and a computer. The data acquisition system is adapted to be removably coupled to the controller module such that the power supply provides power to the controller module when the data acquisition device is coupled to the controller module. The computer is programmed to exchange data with the controller module when the data acquisition device is coupled to the controller module.
In yet another aspect of the invention, a patient home support system includes a power supply and a battery charger adapted to receive and charge the rechargeable battery. A first connector is adapted to removably couple the home support system to the controller module such that the power supply provides power to the controller module when the home support device is coupled to the controller module.
In a still further aspect of the invention, a method of controlling an implanted pump includes the acts of coupling a controller module to the implanted pump. The controller module includes a microprocessor, a display device, a user input device, and a digital memory. The method further includes collecting operating parameters of the implanted pump, displaying the collected parameters on the display device as selected by a user via the input device, storing the collected parameters in the digital memory, and displaying the stored parameters on the display device as selected by a user via the input device.
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Benkowski Robert J.
Lynch Bryan E.
Morello Gino F.
Winstrom William L.
Howrey Simon Arnold & White , LLP
Kamm William
MicroMed Technology, Inc.
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