Surgery – Instruments – Means for concretion removal
Reexamination Certificate
1999-05-25
2001-03-27
Smith, Jeffrey A. (Department: 3732)
Surgery
Instruments
Means for concretion removal
C128SDIG008, C600S562000
Reexamination Certificate
active
06206889
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for removing anatomical parts, devised for surgical operations carried out by laparoscopy.
In a most specific manner, this device comprises a bag wherein the aforesaid parts are placed back and a tube applicator wherein the bag is arranged for being introduced in an abdominal cavity to be operated; the applicator is also provided with means for ejecting the bag out into the cavity above.
DESCRIPTION OF THE RELATED ART
The surgical operations previously referred to, have been studied and developed in recent time; they allow to operate inside the abdominal cavity of a patient, avoiding to make the wide incisions that usually mark the traditional surgical operations: examples of treatments that actually are carried out with laparoscopic technique are the taking of samples of tissues like the appendix or cholecystes, the extirpation of calculi and cyst, as well as some gynecological treatments.
In practice the operations herein considered consist of making on the patient's abdomen some apertures or laparatomies, usually at least two and no more than four, having diameter of few millimeters (from 5 to 15 mm) and devised for the insertion into the abdominal cavity of surgical instruments suitably adapted to this purpose; these instruments may be optical waveguide probes, scissors, pliers, suture devices or, like in the case of the present invention, devices for removing anatomical parts to be taken or extirpated.
Actually two models of the device just mentioned, are known in commerce. The first one, generally considered as the best by the persons of the art even though more expensive, comprises a polyurethane bag on the mouth thereof there is applied a pretensioning metallic ring, resiliently folding and having a diameter of 10 or 15 cm depending on the models; the polyurethane bag is also provided with a twisted polyamide seam, that allows its tightening like a tobacco bag thereby separating it in an automatic manner from the pretensioning ring, by means of a cutting edge of the latter.
The ring in an initial folded condition, together with the empty bag, is located in a cylindrical tube of 10 or 15 mm of diameter, which is inserted into the abdominal cavity to be operated through one of the laparatomies already referred to.
The use of the known device just considered takes place according to a sequence of steps as follows.
After having inserted a distal end of the cylindrical tube into the abdominal cavity of the patient, the bag is pushed out in said cavity by a cursor acting on it, similar to that of a normal syringe and operated from the proximal end of the tube: in this situation the pretensioning ring may thus unfold close to the area to be surgically operated by virtue of its spring action, thereby promptly disposing the related bag in an open condition, ready to accomodate an anatomical part to be removed.
After the part has been put into the bag, the latter is closed by narrowing its mouth pulling the aforesaid polyamide seam; following to this phase the bag is cut off the pretentioning ring and the latter, after having been previously folded, may be drawn out from the cylindrical tube while the former is pulled toward the distal and of the tube: afterward, also the bag may be slipped out of the cavity together with the tube.
On this subject it is pointed out that for the known model of device just described, it is also foreseen the possibility of keeping the bag open inside the abdominal cavity after the pretensioning ring has been drawn out: in this case, however, the detachment of the ring from the bag must be made differently from what has been said before, that is not by closing the mouth of the bag following to the pulling of its polyamide seam, but rather by acting inside the abdominal cavity for making a partial cut of the bag in correspondence of the ring.
From what has been stated heretofore, it is possible to understand that although this known device has the advantage of an automatic and quick opening of the bag thanks to the resilient pretensioning ring, it is however marked by a scarce handyness because of the dimensions of the ring once the latter is open inside the cavity to be operated, and of a certain functioning labouriousness; above all it must be underlined the fact that in this known device, once the bag is closed it is no more possible to re-open it: in other words, with such a device it is not possible to carry out cycles of opening and subsequent closing of the bag which are useful in some kinds of operations, such as those wherein several anatomical parts must be removed (extirpations of small lymph nodes, multiple biopsies) in sequence inside the abdominal cavity, without the risk of their dispersion.
As an alternative to the removing device discussed heretofore, there exists another one available in commerce.
The latter device is provided with the usual bag wherein the anatomical parts are accommodated, whose mouth is however coupled with a flexible ribbon made of plastics such as NYLON (registered trademark) or the like; the bag is applied on the distal end of a cannula and for this reason it is provided with an appendix in correspondence of its mouth, to be sealed on such an end.
The above mentioned ribbon is located for a portion in a turn-up edge of the mouth of the bag, whereas its two free ends are arranged inside the above mentioned cannula and are connected to the tip of a cursor rod axially slidable within it: in this manner the ribbon takes a loop configuration that will be better appreciated later. Likewise the previous model, in this device the cursor is operated from the proximal end of the cannula like a syringe and moves between a forward end stroke position and a rearward one.
In accordance with the movements of the cursor, the ends of the ribbon connected to it are placed, respectively, adjacent to the distal end of the cannula or inside to it: in the first case the ribbon protrudes basically for all its length off the distal end of the cannula and the loop that it forms has such a length as to allow the mouth of the bag to be in the maximum opening condition; in the second case, instead, the ribbon is located mainly inside the cannula so that the mouth of the bag is closed following to the relative sliding between its turned-up edge and the ribbon.
This second model of device just referred to allows, differently from the first one, to carry out repeated opening and closing cycles of the bag, thereby representing under this point a technical improvement; this outcome is due essentially to the fact that it does not have a rigid pretensioning ring associated to the mouth of the bag, but rather a flexible element like the ribbon made of plastic material.
However it is not able to ensure an automatic and quick first opening of the bag like it occurs for the previous example.
It must indeed been taken into account that when the distal end of the cannula is introduced in the abdominal cavity, for opening the bag applied thereto the surgeon must make use of pliers or other surgical instruments because even by acting on the cursor of the device, the ribbon surrounding the mouth of the bag cannot lay itself in the loop configuration sought: this is due to the intrinsic features of the ribbon useful for folding it as explained before. Similar difficulties may further arise also in the case of possible subsequent opening phases of the bag, thereby limiting infact the performances of this device. It can also be appreciated that the limit just outlined relating to the opening of the bag, increases with the growth of the dimensions: it can indeed be understood that the difficulties for unfolding the material of the bag are increased by such a growth, in particular for what it concerns the mouth and the capability to achieve the loop configuration of the ribbon. This argument may thus explain the reason why this second known model of device is available in commerce with bags of small dimensions, which are therefore not useful for removing anatomical parts of a certain size
Pillsbury Madison & Sutro LLP
Smith Jeffrey A.
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