Apparatus for two-path distribution of a sterile operating...

Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...

Reexamination Certificate

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Reexamination Certificate

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06322533

ABSTRACT:

The present invention concerns an apparatus for distribution under controlled pressure and flow of a sterile liquid within a broad range of pressures and according to predefined sequences in pulsed or continuous operation for at least one hand unit intended for medical and surgical applications.
BACKGROUND OF THE INVENTION
The technique of aqua dissection, which uses a high-pressure sterile liquid jet fed to a simple hand unit or to one with aspiration like that described in the published patent application WO 9703713 by SAPHIR MEDICAL, is known.
The action of the high-pressure liquid is a tissue cutting action which is more or less incisive depending on the pressure value.
There are other hand units which are used for rinsing or for lavage, with the sterile liquid distributed in that case under low pressure with adjustable flow.
The sterile liquid is delivered by a source adjustable either in pressure or in flow, for example, that of the generator described in publication WO 9428807 by SAPHIR MEDICAL.
This generator comprises a leak-proof chamber enclosing a flexible pouch containing the sterile liquid. The inner volume of the chamber is adjustably pressurized with a neutral gas. The pneumatic force of this gas expels the sterile liquid from the pouch to the output line. Depending on the hand unit type, i.e., dissection or lavage/rinsing, the liquid coming out is used under pressure or in flow, respectively.
This generator enables successive performance of the two functions corresponding to these two categories of applications. Switching from one to the other necessitates a modification of the tubing and of the hydraulic component.
Thus, this continuous flow generator is limited to distributing sterile liquid by a single type of action at one time, either dissection or lavage/rinsing.
Moreover, the jet is continuous and the generator was provided to feed only a single handpiece at a time.
Thus, it is necessary to change the mode of operation and the conduits each time a switch is made from pressure operation to flow operation, i.e., from the use of a dissection handpiece to a lavage/rinsing unit and vice versa.
The work is performed under aspiration of the operating liquid through the aspiration network, for example, that of the operating theater connected to the evacuation via a vacuum pump.
As the generator is a continuous source, the applications remain limited to those of a continuous jet with adjustable pressure or to diffusion by spraying for the purposes of lavage/rinsing or of irrigation.
Moreover, the advantages of pulsed jets which enable improvement of the precision of dissection work while reducing the pressure and the consumption of the liquid are known in surgery.
This work results from successive sets or trains of periodic pressurized liquid firing pulses, with the pause between the successive sets used for aspiration of the liquid fired and of the biological residues.
Although this pulsed operation enables improvement of the precision of the dissection, the depth of the incision is difficult to control, and efficacy is difficult to guarantee in shallow dissections. Moreover, the visibility of the operative field could be appreciably improved.
SUMMARY OF THE INVENTION
The present invention concerns an apparatus which operates with any type of pressurized liquid sources or generators and with any type of aspiration means. Provision is also made for operation with any type of handpieces controlled manually in various ways, in particular by pneumatic discontinuity.
The apparatus according to invention also targets all medical and surgical applications in which a jet or addition of sterile liquid is used to perform cutting, shaping, cleaning, rinsing, irrigation, or any other work.
Aquadissection, tissue lavage, irrigation of a natural cavity of the human body, shaping of masses of flesh in cosmetic surgery, tumor disintegration, and numerous other examples can be cited.
The distribution apparatus according to the invention is intended to be universal for medical and surgical applications because it can supply handpieces with different functional characteristics depending on the type of work required. It can be used within the framework of cardiac or liver surgery or any other surgical operation and for pulverization and evacuation of a tumor, each of which requires special, different handpieces and specific operating conditions and jet forms.
For example, the work of dissection and disintegration of a tumor is performed under constant suction designed to evacuate not only the liquid used for the cutting or disintegration but also the residues such as tissues, cells, and organic matter and liquids.
To accomplish this, the handpieces include two paths or channels, one for dissection, connected to the pressurized sterile liquid, and the other for evacuation, connected to the depression source.
In its basic version, the sterile liquid distribution apparatus is connected to a pressurized liquid source and to aspiration means and is made up of the following general means:
a pressurized liquid distribution channel connected to a dissection handpiece for operation in pulsed-aspirated or continuous mode;
a flowing liquid distribution channel connected to a lavage/rinsing or irrigation handpiece for operation under continuous manual control;
a control module generating a periodic pulsed pattern of opening/closing of flows in the pressure channel according to predefined sequences;
specific functions enabling the handpiece to be manually controlled by pneumatic discontinuity.
More specifically and more completely, the major functions of the apparatus may be summarized descriptively as follows.
First, the distributor includes at least two different channels, each of which is connected to a dissection handpiece, on the one hand, and to a lavage/rinsing handpiece, on the other hand.
A. The dissection channel includes:
a pressurized sterile liquid distribution conduit connected to a dissection handpiece;
a depression conduit connected to the dissection handpiece;
sequential synchronized means for periodic opening/closing of the depression, acting on the depression conduit;
means for periodic aeration of the depression synchronized with the first, acting on the depression channel;
synchronized means for periodic opening/closing of the pressurized dissection liquid.
The periodic opening/closing control means can be mutually synchronized for common pulsed operation according to a modifiable cyclic program.
The control means can be deactivated to switch to continuous operation.
B. The lavage/rinsing channel includes:
a sterile liquid distribution conduit with adjustable flow connected to a lavage/rinsing or irrigation handpiece;
a conduit with adjustable depression connected to the same lavage/rinsing handpiece;
means for adjusting the flow of the sterile liquid and the depression;
manual control means for opening/closing the liquid flow;
manual control means for opening/closing the depression connected to the preceding liquid control means.
This entirely novel apparatus has numerous advantages of which a few will be indicated in the following:
there are two paths or channels which can function simultaneously independent of each other, each connected to a specific handpiece, use of which may be simultaneous or successive within the framework of activity in a single operative field,
the two channels can distribute the working fluid and aspirate in pulsed or continuous operation independently of each other,
the program sequences producing the appropriate waveforms of the pulsed operation are pre-recorded and specific to a given application. They constitute the optimum for this application,
conduit connections and placement are facilitated, sterility is guaranteed at all levels,
a special circuit is provided to implement the operational controls of the handpieces based on the pneumatic variation of a fluid,
the mechanical means ensure the interruptions of fluid flows under sterile conditions,
it is possible to connect the two channels to a single mixed-use handpiece,
the apparatus enab

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