Surgery – Instruments
Reexamination Certificate
1999-07-23
2003-02-11
Jaworski, Francis J. (Department: 3737)
Surgery
Instruments
C600S439000, C600S459000
Reexamination Certificate
active
06517530
ABSTRACT:
This invention relates to a probe-device having an auxiliary element for use during surgery, where there is employed a surgical instrument of the type comprising a relatively elongate, rod-shaped member being provided with a work element at its outer, free end. An auxiliary in this connection can be a sensor element for the detection of physiological parameters, or as an alternative the auxiliary can be an instrument or tool element intended for active use by the surgeon during the operation. Thus in principle this latter form of auxiliary can be of a similar type as the work element referred to at the surgical instrument with which the probe device is adapted to cooperate.
In the following description a starting point has mainly been taken in a device having an auxiliary element of the first mentioned type, namely a sensor element e.g. in the form of an ultrasonic transducer. In general there can here be the question of sensors for detection of various physiological parameters (such as pulse, blood pressure, oxygen saturation and so forth) and physiological structures (blood vessels) during an operation carried out with endoscopic or other tecniques.
It is considered in this connection that the surgical instrument with which the probe device can be associated or cooperate, can be a surgical instrument of a standard type, which inherently is designed to be used by the surgeon during operations without being assisted by the specific probe device according to the invention.
This probe device can be employed in most situations where a surgical instrument, being either rigid or flexible, is already employed during an endoscopic operation. Endoscopic and laparoscopic surgical methods have been much developed during recent years. More and more operations are carried out with endoscopic techniques, which today are based on rigid or flexible instruments controlled by the operator by means of light optics in the endoscopes. In laparoscopic operations it is necessary to introduce several instruments simultaneously through several small openings (ports) in the abdominal wall. Light and optics then have a dedicated port and the surgical instruments are used in from one to four extra ports.
The situation today is such that usually there are not employed probes or instruments for detecting physiological parameters during endoscopic operations. The reason is that the surgeon is reluctant to introduce still another surgical tool into the work field. If this tool is to be available at any time it must be introduced through a separate port. It is desired to keep the number of ports at a minimum, so as to ease the patient's trauma and increase the safety of the operation. To dedicate a separate port for an instrument for physiological parameter determination, is not considered to be expedient during standard procedures where the duration of the operation has great importance. If such an instrument shall be used during an operation where there is not allocated any dedicated port, it will be necessary to perform a change from surgical instrument to detection instrument in one of the ports. This is a time-consuming process. It is desirable to have as few instrument changes as possible in order to keep the operation time short. Endoscopic techniques involve the possibility of the surgeon to have palpating contact with physiological structures. In order to maintain safety margins the surgeon will proceed very carefully and let further work be based on visual verification of the physiology through the light and video channels of the endoscopes. It is a cumbersome work and a time-consuming process to expose all structures for verification before the surgical procedure can proceed. This is a time-consuming process. When using an instrument for detecting physiological parameters, such as blood vessel detection, the verification of structures lying underneath, can be made before visual verification is possible. The endoscopic procedures can be performed more quickly and safely, which saves the patient for great strain in connection with long operations and a long convalescense time. This leads to cost effective savings.
Thus it is a general object of the invention to provide a probe device which together with a surgical standard instrument constitutes a simple and very useful tool unit at the disposal of the surgeon, so that the surgeon in situations as discussed above, in a more simple manner and more easily can carry out difficult steps during an operation. In this connection it is also very important that the probe device makes possible very inexpensive solutions, taking into account among other things that common surgical standard instruments are taken as a basis.
Previously known methods and techniques of interest in this context, can be considered to be represented by the following patent specifications:
[1] U.S. Pat. No. 5,325,860
[2] U.S. Pat. No. 5,353,783
[3] U.S. Pat. No. 5,275,166
[4] U.S. Pat. No. 5,413,107
Aspects of technological methods for detecting blood vessels are known from other clinical connections and purposes. Ultrasound doppler and ultrasound imaging are described for the purpose of detecting blood vessels in time and to be able to clamp these during laparoscopic operations [3]. An ultrasound system is located on an endoscopic instrument dedicated for blood vessel detection or in combination with a clamping tool or the like. There is described a catheter whereby ultrasound imaging monitors a surgical instrument introduced through the lumen of the catheter [1]. A laparoscopic ultrasound imaging instrument having a flexible tip is described for dedicated ultrasound imaging of a surgical region [4]. A surrounding hose is described for use outside an existing endoscope [2]. The hose serves as a sterile protection for the endoscope and in addition contains several external foldable work channels for introducing endoscopic tools.
On the above background the novel and specific features of the probe device according to the invention in the first place consists in a sleeve-shaped main part adapted to be mounted externally of the rod-shaped member of the instrument, being either rigid or flexible, and provided with the auxiliary element at one end, corresponding to the outer free end of the rod-shaped member, said main part being slideable in its longitudinal direction between two extreme positions, namely a retracted and an extended or forward position, with a resulting altered position of the auxiliary element in relation to the work element.
In a typical practical embodiment based on the invention, this novel probe device thus comprises a main part or supporting part in the form of a sleeve at the end of which there is mounted one or more sensors for detection. This sleeve can be threaded onto a standard endoscopic surgical instrument, as a supplement to the function thereof. The sleeve can be threaded so far onto the surgical instrument that during normal work conditions it is outside the field of work of the surgical instrument. When situations occur, where it is important to investigate the surgical region concerned, with respect to measurable physiological parameters given by the sleeve sensor or sensors, the sleeve can be moved forwardly along the surgical instrument by means of a release mechanism, so that the sensor or sensors enter into the field of work. When parameter determination has been finished the sleeve is retracted along the instrument and out of its field of work.
The present invention makes its possible to combine any endoscopic instrument with a probe for detecting physiological parameters or detectable physiological structures. The surgeon selects which of the endoscopic instruments it is suitable to provide with this auxiliary function. The surgeon will have the opportunity to increase safety during the operation, by being at an early stage able to verify hidden physiological structures, and to shorten the intervention time without introducing a dedicated port and without exchang
Duane Morris LLP
Jaworski Francis J.
Leiv Eiriksson Nyfotek AS
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