Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2002-04-15
2004-04-20
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S170000, C600S471000
Reexamination Certificate
active
06723110
ABSTRACT:
BACKGROUND OF THE INVENTION
The art of the present invention relates to ultrasonic surgical devices in general and more particularly to a high efficiency ultrasonic tip for use in neurosurgery and other surgical disciplines. The use of ultrasonic aspirators in neurosurgery is well understood and recognized in the field of neurosurgery. Ultrasonic aspiration provides for emulsification and in situ evacuation of intracranial tumors. In this way, retraction of eloquent brain is minimized, while disruption and removal of tissue is advanced.
Prior art ultrasonic aspirators typically utilize a tubular tip having a threaded connecting end and a contacting end. The threaded connecting end attaches to an ultrasonic generator handpiece which injects ultrasonic energy into the tip and further allows for aspiration through said tubular tip. Said energy causes said tubular tip to elastically elongate and retract along the tubular axis at a frequency corresponding to the ultrasonic excitation frequency of the ultrasonic generator. Often the contacting end of said prior art devices is best described as a planar cut perpendicular to the tubular axis of the tubular tip. In other words, the contacting end is simply a flat cut at the tube end which is again perpendicular with the lengthwise tubular axis of the tip.
Prior art ultrasonic aspirators for neurosurgery rely solely upon the phenomenon of cavitation to reduce tissue to its emulsified form. That is, the contacting end of said prior art extends and retracts up to 350 microns at a rate from 20 to 50 kilohertz, thereby producing an ultrasonic field which creates a low pressure cavitation zone at the contacting end. The resulting low-pressure zone at the tip of the aspirator causes cell wall collapse and release of intracellular fluid which creates an emulsate. Therafter, said emulsate is aspirated through said tubular tip via the action of an aspiration system connected inline with said ultrasonic generator handpiece and said tubular tip.
This prior art method of emulsification and aspiration is extremely safe, as it maintains some selectivity of destruction and limits disruption of tissues with low water mass. However, there are times when this selectivity becomes problematic. Fibrotic meningiomas and calcified tumors are minimally affected by the aforementioned cavitation phenomenon thereby dramatically increasing operative time or in some instances completely prohibiting the use of ultrasonic aspiration for their removal. Hence, the benefits of in situ evacuation are lost on these pathologies. Likewise, tumors previously treated with radiosurgery can often find themselves “welded” to surrounding pathology. (i.e. dura, bony prominences within the skull base, etc.) Again, the aforementioned limitations of ultrasonic aspiration apply.
The present art utilizes an ultrasonic field to produce the aforementioned cavitation along with a cutting action at the contacting end of the uniquely designed tubular tip. That is, the present art provides in situ evacuation of the aforementioned intracranial tumors. The aforesaid cutting is promoted at the ultrasonically excited contacting end when the contacting end is not perpendicular to the tubular axis of the tubular tip. In other words, since the ultrasonically excited contacting tip longitudinally extends up to 350 microns, a slicing or mechanical cutting action may be promoted when the contacting tip has an angle relative to the tubular axis. Unfortunately, a simple angle on the contacting end relative to the tubular axis does not promote efficient aspiration or an optimum ultrasonic field.
The present invention represents a tubular tip having a “V” or “U” shaped cut or notch within the contacting end which provides optimum slicing or cutting action while also maintaining asymmetrical handpiece operation, an optimum ultrasonic cavitation field, and optimum aspiration. That is, the present invention represents a tubular tip which is utilized in the aforementioned prior art ultrasonic generator handpiece and provides the traditional ultrasonic and aspiration benefits and allows a surgeon to use the ultrasonic handpiece in any rotational axis position. The tubular tip has a connecting end and a contacting end, yet the contacting end is uniquely shaped to provide the aforementioned cutting action. In a preferred embodiment, said contacting end contains a substantially “V” or “U” shaped cut which provides the desired cutting or slicing action along with a desirable locus for uniform aspiration and ultrasonic field generation. The base of the aforementioned “V” or “U” cut is placed opposite the contacting end, or towards to the connecting end.
Accordingly, it is an object of the present invention to provide a high efficiency ultrasonic surgical aspiration tip having a contacting end which promotes mechanical cutting and slicing of various tissues and other materials, including fibrotic meningiomas and calcified tumors.
Another object of the present invention is to provide a high efficiency ultrasonic surgical aspiration tip having a threaded end which functions with prior art ultrasonic generator handpieces, produces a substantially uniform optimum ultrasonic and aspiration field, and also provides the desired cavitation.
A further object of the present invention is to provide a high efficiency ultrasonic surgical aspiration tip which provides an asymmetrical ultrasonic generator handpiece operation while also promoting efficient and convenient aspiration.
SUMMARY OF THE INVENTION
To accomplish the foregoing and other objects of this invention there is provided a high efficiency ultrasonic surgical aspiration tip and method of using the same. The method and apparatus provide for a unique and desired cutting or slicing action while further providing the traditionally desired aspiration and ultrasonic field generation. In a preferred embodiment, the apparatus is claimed in conjunction with a conventional ultrasonic generator handpiece of a surgical aspirator and the method of use is claimed in conjunction with the action of surgical tissue and tumor removal.
As aforementioned, in its preferred embodiment, the present art represents a tubular tip having a connecting end, a contacting end, and a “V” or “U” shaped cut or notch within the contacting end which provides optimum slicing or cutting action while also maintaining asymmetrical handpiece operation, an optimum ultrasonic cavitation field, and optimum aspiration through the interior tube portion of the tip. In the preferred embodiment, the base of said “V” or “U” shape is positioned closer to the connecting end than the legs of the “U” or “V”. That is, the tips of the legs of the “U” or “V” represent the tip of the contacting end and face away from the connecting end. In the preferred embodiment, the connecting end comprises a male threaded portion which mates with a female threaded portion on the ultrasonic generator handpiece. Said connecting end further comprises a shoulder, away from said connecting end and toward said contacting end, which seats upon and with the mating end of the acoustic horn of the ultrasonic generator handpiece of the aspirator. Alternative embodiments may utilize attachment methods at the connecting end other than threads. These include but are not limited to mating pinned portions, welding, sweated connections, soldered connections, brazed connections, mechanical quick disconnects, and ball and detent connections.
Alternative embodiments utilize variations of the “V” or “U” cut in the contacting end. That is, a first alternative embodiment contains multiple “V” or “U” cuts at the contacting end which form in combination a serrated cut at the contacting end. Further alternative embodiments embody an asymmetrical “V” or “U” shaped cut at the contacting end. That is, one leg of the “V” or “U” is shorter or longer than the other. Still further alternative embodiments provide honed or sharpened edges on said contacting end to further the aforementioned cutting action.
In all of the aforementioned preferred and alternative embodime
Auld Mike
Timm Ed
Davis D. Jacob
Klug Kevin L.
Milano Michael J.
Synergetics, Inc.
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