Surgery – Instruments – Electrical application
Reexamination Certificate
1998-10-06
2001-05-15
Cohen, Lee (Department: 3739)
Surgery
Instruments
Electrical application
C606S041000, C607S102000, C128S923000
Reexamination Certificate
active
06231569
ABSTRACT:
SUMMARY OF THE INVENTION
1. Field of the Invention
This invention relates to the field of electro-surgical medical devices. More particularly, this invention relates to devices that deliver energy in the form of radio-frequency electrical current to tissue in order to perform surgical functions.
2. Description of Related Art
Various medical procedures rely on high-frequency electrical currents to deposit energy and thus heat human and animal tissues. During such procedures, a high-frequency current is passed through the tissue between electrodes. One electrode is located at the tip of a surgical probe. Another electrode is located elsewhere, and may be a ground pad or another surgical probe tip. The tissue to be treated lies between the electrodes.
When the electrode circuit is energized, the electric potential of the electrodes at the probe tips oscillates at radio frequencies about a reference potential. If one is used, a ground pad remains at a floating reference potential. As the electric potential of the probe electrodes varies, a motive force on charged particles in the tissue is established that is proportional to the gradient of the electric potential. This electromotive force causes a net flow of electric charge, a current, to flow from one electrode, through the tissue, to any other electrode(s) at a lower potential. In the course of their flow, the charged particles collide with tissue molecules and atoms. This process acts to convert electrical energy to sensible heat in the tissue and is termed Joule heating.
Upon heating, surgical functions such as cutting, cauterizing and tissue destruction can be accomplished. For example, tissues can be cut by heating and eventually vaporizing the tissue cell fluids. The vaporization causes the cell walls to rupture and the tissue to cleave. When it is beneficial to destroy tissue, comparatively higher rates of energy deposition can cause tissue ablation.
Ablation of cellular tissues in situ is used in the treatment of many diseases and medical conditions either alone or combined with surgical removal procedures. Surgical ablation is often less traumatic than surgical removal procedures and may be the only alternative where other procedures are unsafe.
The Food and Drug Administration (FDA) requires an extensive validation process for approval of radio frequency (RF) electro-surgical devices. This evaluation is designed to assure that any risks associated with this type of surgical procedures are minimized. The validation process requires documenting and testing all possible states and exceptions that can be generated by the combined hardware and software that makes up the RF Electro-Surgical device. Depending on the level of concern every line of source code must be documented to the satisfaction of the FDA. The degree to which computer controlled medical equipment is verified and validated depends on the level of concern. These levels of concern can also be applied to subsystems within a system. This latter requirement has prevented the introduction of complex graphical user interfaces (GUIs) for electro-surgical devices. Complex graphical user interfaces are certainly available on personal computers. These interfaces are generated using the proprietary software of companies such as Microsoft, e.g. Windows 95® and Apple Computer, e.g. System 7®. However, the source code for these well know operating systems is proprietary and thus can not be verified to the satisfaction of the FDA. Absent the use of these complex operating systems and development environments they provide, companies manufacturing electro-surgical devices have been limited in the complexity of their GUIs to those which can be generated with source code written in house. Typically electro-surgical device displays are limited to one or two lines of alphanumeric display without any graphical capability.
What is needed is a way to create for electro-surgical instruments the more user-friendly GUIs found in Microsoft's or Apple's operating environments while staying in compliance with FDA guidelines for computer controlled surgical equipment.
SUMMARY OF THE INVENTION
The present invention provides for an electro-surgical instrument with a rich graphical user interface (GUI) capability and a verifiable hardware and software platform meeting Food and Drug Administration (FDA) requirements. The rich GUI makes for a device which is more easily operated than prior art devices which lacked a sophisticated user interface. The increased functionality is achieved without sacrificing the ability to validate the device for FDA purposes. This goal is achieved by a dual processor design. In the dual processor design a control or master processor with verifiable source code implements the functions of: power delivery, temperature measurement, power measurement and power control. A display or slave processor, is functionally isolated from the first processor receiving only messages from the first processor.
In a first embodiment of the invention an electro-surgical instrument is disclosed. The electro-surgical instrument includes a power delivery channel, at least one electrode and a display. The electro-surgical instrument also includes a control unit and a display unit. The control unit controls the operation of the power delivery channel and at least one electrode to deliver power to the surgical site. The control unit also determines at least one parameter of the power delivery channel and passing the parameter to the display unit. The display unit is coupled to the control unit and the display. The display unit accepts the at least one parameter, generates the graphical user interface on the display and displays the at least one parameter on the graphical user interface.
In another embodiment of the invention a method for providing a graphical user interface in an electro-surgical instrument is disclosed. The electro-surgical instrument includes a power delivery channel, at least one electrode and a display. The method for providing comprises the acts of:
controlling with a control unit the operation of the power delivery channel and at least one electrode to deliver power to the surgical site;
determining with the control unit at least one parameter of the power delivery channel;
passing the at least one parameter from the control unit to a display unit;
accepting at the display unit the at least one parameter; and
displaying the at least one parameter on a graphical user interface generated by the display unit.
REFERENCES:
patent: 5233515 (1993-08-01), Cosman
patent: 5868737 (1999-02-01), Taylor et al.
patent: 5871481 (1999-02-01), Kannenberg et al.
patent: WO 97/ 20510 (1997-06-01), None
Bek Robin
Koenig Franklin R.
Wills David
Cohen Lee
Ruddy David M.
Somnus Medical Technologies Inc.
Wilson Sonsini Goodrich & Rosati
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