Surgery – Instruments – Means for concretion removal
Reexamination Certificate
1999-04-23
2001-04-10
Mancene, Gene (Department: 3732)
Surgery
Instruments
Means for concretion removal
Reexamination Certificate
active
06214017
ABSTRACT:
BACKGROUND
1. Technical Field
This disclosure relates to surgical systems and, more particularly to an improved ultrasonic surgical apparatus for ultrasonically fragmenting tissue.
2. Background of Related Art
Devices which effectively utilize ultrasonic energy for a variety of applications are well-known in a number of diverse arts. The application of ultrasonically vibrating surgical devices used to fragment and remove unwanted tissue with significant precision and safety has led to the development of a number of valuable surgical procedures. Accordingly, the use of ultrasonic aspirators for the fragmentation and surgical removal of tissue from a body has become known. Initially, the technique of surgical aspiration was applied for the fragmentation and removal of cataract tissue. Later, such techniques were applied with significant success to neurosurgery and other surgical specialties where the application of ultrasonic technology through a handheld device for selectively removing tissue on a layer-by-layer basis with precise control has proven feasible.
Certain devices known in the art characteristically produce continuous vibrations having a substantially constant amplitude at a predetermined frequency (i.e 20-30 kHz). Certain limitations have emerged in attempts to use such devices in a broad spectrum of surgical procedures. For example, the action of a continuously vibrating tip may not have a desired effect in breaking up certain types of body tissue, bone, etc. Because the ultrasonic frequency is limited by the physical characteristics of the handheld device, only the motion available at the tip provides the needed motion to break up a particular tissue. The limited focus of such a device may render it ineffective for certain applications due to the vibrations which may be provided by the handheld device. For certain medical procedures, it may be necessary to use multiple hand held devices or it may be necessary to use the same console for powering different handheld devices.
Certain devices known in the art characteristically produce continuous vibrations having a substantially constant amplitude at a frequency of about twenty to about thirty kHz up to about forty to about fifty kHz. The amplitude is inversely proportional to frequency and directly proportional to wavelength. U.S. Pat. Nos. 4,063,557, 4,223,676 and 4,425,115 disclose devices suitable for the removal of soft tissue which are particularly adapted for removing highly compliant elastic tissue mixed with blood. Such devices are adapted to be continuously operated when the surgeon wishes to fragment and remove tissue, and generally is operated by a foot switch.
A known instrument for the ultrasonic fragmentation of tissue at an operation site and aspiration of the tissue particles and fluid away from the site is the CUSA model System 200 Ultrasonic Aspirator manufactured and sold by Valleylab, Inc. of Boulder, Colo., a subsidiary of U.S. Surgical Corporation; see also U.S. Pat. No. 4,827,911. When the longitudinally vibrating tip in such an aspirator is brought into contact with tissue it gently, selectively and precisely fragments and removes the tissue. Advantages of this unique surgical instrument include minimal damage to healthy tissue in a tumor removal procedure, skeletoning of blood vessels, prompt healing of tissue, minimal heating or tearing of margins of surrounding tissue, with minimal pulling of healthy tissue, and excellent tactile feedback for selectively controlled tissue fragmentation and removal is provided.
In many surgical procedures where ultrasonic fragmentation instruments are employed additional instruments are required for tissue cutting and hemostasis at the operation site. For example, hemostasis is needed in desiccation techniques for deep coagulation to dry out large volumes of tissue and also in fulguration techniques for spray coagulation to dry out the surface of tissues.
The apparatus disclosed in U.S. Pat. Nos. 4,931,047 and 5,015,227 provide hemostasis in combination with an ultrasonically vibrating surgical fragmentation instrument and aspirator. The apparatus effectively provide both a coagulation capability and an enhanced ability to fragment and aspirate tissue in a manner which reduces trauma to surrounding tissue.
U.S. Pat. No. 4,750,488 and its two continuation Patents, 4,750,901 and 4,922,902 disclose methods and apparatus which utilize a combination of ultrasonic fragmentation, aspiration and cauterization.
In an apparatus which fragments tissue by the ultrasonic vibration of a tool tip, it is desirable, for optimum efficiency and energy utilization, that the transducer which provides the ultrasonic vibration should operate at resonant frequency. The transducer design establishes the resonant frequency of the system, while the generator tracks the resonant frequency. The generator produces the electrical driving signal to vibrate the transducer at resonant frequency. However, changes in operational parameters, such as, changes in temperature, thermal expansion and load impedance, result in deviations in the resonant frequency. Accordingly, controlled changes in the frequency of the driving signal are required to track the resonant frequency. This is controlled automatically in the generator.
During surgery, fragmentation devices, such as the handpieces described above, are used internally to a patient. A surgeon manipulates the handpiece manually at an operative site, and therefore the handpiece itself may reduce visibility of the operative site. It would therefore be advantageous to provide an apparatus with the above described features with a smaller profile such that a greater field of view is provided for the surgeon at the operative site.
SUMMARY
An improved ultrasonic surgical apparatus having reduced size includes an ultrasonic handpiece. An ultrasonic fragmenting tool is mounted within the handpiece, the tool having a vibratable tip adapted for ultrasonically fragmenting tissue at a surgical site of a patient. A transducer is mounted within the handpiece and coupled to a connecting body. The connecting body is coupled to the tip for transmitting ultrasonic waves to the tip from the transducer, the tip and the connecting body being constructed of titanium or its alloys. An aspirating system is connected to the handpiece for aspirating fluid and tissue fragmented by the tip from the surgical site. An irrigation system is connected to said handpiece for supplying irrigation fluid to the surgical site for suspending fragmented tissue by the tip.
Another improved ultrasonic surgical apparatus having reduced size includes an ultrasonic handpiece. An ultrasonic fragmenting tool is mounted within the handpiece, the tool having a vibratable tip adapted for ultrasonically fragmenting tissue at a surgical site of a patient. A transducer is mounted within the handpiece and coupled to a connecting body. The connecting body is coupled to the tip for transmitting ultrasonic waves to the tip from the transducer, the connecting body is coupled with the tip for transmitting ultrasonic waves at a frequency of at least 35,000 Hz to the tip from the transducer. An aspirating system is connected to the handpiece for aspirating fluid and tissue fragmented by the tip from the surgical site. An irrigation system is connected to said handpiece for supplying irrigation fluid to the surgical site for suspending fragmented tissue by the tip.
In alternate embodiments of the ultrasonic surgical apparatus systems described, the transducer may include a stack of magnetostrictive plates longitudinally disposed within the handpiece and responsive to an input frequency for vibrating the tip. The plates can be flat or gusseted and may be fabricated of nickel or alloys thereof. The entire acoustic vibrating assembly (the transducer and its associated components) determines the system frequency. A fluid supply for introducing cooling fluid to the fragmenting tool and/or the transducer may also be provided. The aspiration system may include a detachable aspiration line wherein the aspiration
Reschke Arlan James
Stoddard Robert
Mancene Gene
Robert Eduando C.
Sherwood Services AG
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