Surgery – Instruments
Reexamination Certificate
2001-07-19
2003-05-06
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
C604S513000, C604S539000, C600S206000
Reexamination Certificate
active
06558371
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an apparatus for holding a trocar sleeve in different spatial orientations relative to a patient, comprising a base member fixedly positionable relative to the patient and a retainer for the trocar sleeve, where the retainer is connected to be tiltable with respect to the base member by a flexible connecting member.
A holding apparatus of this type is disclosed in U.S. Pat. No. 5,540,675.
A trocar provides access into the body in minimally invasive surgery. A small incision can be made with a trocar mandrel, through which incision the trocar sleeve is inserted into the body of the patient. The trocar mandrel is subsequently withdrawn from the trocar sleeve. The trocar sleeve thus forms an access channel into the body of the patient.
Trocars are used particularly in minimally invasive surgeries in the stomach region, the field of laparoscopy. Its use however is not limited thereto. Medical instruments can be reliably guided and held in the channel formed by the trocar sleeve and, in addition, the channel serves to supply or discharge fluids or gases into or out of the patient's body. For this purpose, a flap valve housing is usually provided at the proximal end of the trocar sleeve with corresponding sealings and stop cocks.
The trocar sleeve is located in a spatial orientation corresponding to the incision channel. The trocar sleeve however can be varied in its orientation by hand; it returns to the direction of the incision channel when the tube is released. This results from the tendancy of the tissue layers penetrated by the trocar to realign themselves to a certain position. For this reason, apparatus of the above-mentioned type are used to hold the trocar sleeve in certain positions.
One or more different spatial orientations of the trocar sleeve is desirable during a surgery. In a first operational state, the holding apparatus retaining the trocar sleeve is slightly adjustable. Once the trocar sleeve is oriented in the desired position, it should no longer change its disposition. In a second operational state, the holding apparatus is rigid and the trocar sleeve remains fixed in the selected spatial orientation.
The holding apparatus disclosed in mentioned U.S. Pat. No. 5,540,675 comprises an annular base portion which is directly secured to the patient's body with an adhesive layer. The annular base portion is connected with elastic, rubber connecting members to a retainer arranged centrally with respect to the base portion and in the starting condition perpendicular to it. The retainer in the present case itself is tube-shaped. The trocar sleeve is inserted into the retainer. To orient and to fix the retainer in different directions with respect to the base portion, a telescopic-like tensioning mechanism is provided consisting of at least one tensioning element adjustable in length. It is secured between the radially outward region of the base portion and the end of the retainer lying remote from the base portion. The inclination of the retainer relative to the base portion can be varied by adjusting the length of the tensioning element. However, it is first necessary to release the tensioning element with a screw, to adjust the tensioning element to the desired length and finally to again tighten the screw. In one embodiment of the known holding apparatus, three tensioning elements in the form of a tripod are arranged about the retainer for reasons of stability. The trocar sleeve can only be tilted in one single plane with one tensioning element. The adjustment and securement of the desired position of the retainer is complicated in this known holding apparatus. To change the spatial position of the trocar sleeve, all three tensioning elements for fixing the retainer must first be released, and then adjusted and finally retightened. Should the operator after inserting an instrument, for example an endoscope, find that the orientation is not yet exact, he must again carry out the complicated procedure. Extremely tilted positions of the trocar sleeve are not achievable in a stable manner due to the tripod geometry.
Furthermore, the tensioning elements of this known apparatus comprise numerous bacterial niches, cavities and corners, for example the threadings of the adjustable screws and the telescopic shafts, so that the known apparatus is difficult to clean and to sterilize.
Another type of apparatus for aligning and fixing medical instruments is described in the U.S. Pat. No. 5,597,146, which is representative for numerous similar arrangements. This type of apparatus comprises a multi-link pivot arm, whose individual link elements can be oriented independent from one another about different axes. A medical instrument to be fixed can be positioned and held at an arbitrary position, similar to a robot arm. This type of apparatus however is very complicated with respect to its construction and manufacture. In addition, it takes up space on the operating table above the patient and thus obstructs the surgeon's access to the patient from several directions.
It is, therefore, object of the present invention to provide an apparatus of the mentioned type, which is simple to operate and enables a rapid and at the same time reliable adjustment and fixation of the spatial orientation of the trocar sleeve relative to a patient.
SUMMARY OF THE INVENTION
This object is achieved in that the connecting member has a first operational state in which it is flexible and a second operational state in which it is rigid and in that the connecting member is switchable between the first flexible and the second rigid operational state.
The apparatus according to the invention does not require telescopic-like or column-like tensioning elements held with screws, whose handling is cumbersome and complicated. The invention instead provides the degree of flexibility or of rigidity of the flexible connecting member to be variable itself. It is therefore possible in a first operational state, where the connecting member is flexible, to align the trocar sleeve and also the medical instrument therein in the desired position. By switching over to the second operational state where the connecting member is rigid, the trocar sleeve is then fixed in the adjusted position.
The realization of a connecting member with two such different operational states is technically possible in different ways. Preferred manners of realization are correspondingly described in the following with reference to the dependent claims.
The apparatus according to the present invention has the advantage that the adjustment and fixation of the trocar sleeve position and therefore the medical instrument passed therethrough, is easily possible in any, even extreme tilted position in the first flexible operational state, while the adjusted position is safely and reliably held in the second rigid operational state. Compared to the known apparatus, the present apparatus is much easier to operate. At the same time, it is possible to place the present apparatus with its base directly adjacent to the patient to be treated, for example on his abdominal wall. This has the advantage that the apparatus and therefore the trocar sleeve held therein follows changes in the position of the patient. An undesired relative movement of the trocar sleeve with respect to the patient is avoided. Finally, the present apparatus requires very little space, so that access to the patient from different sides is not obstructed.
The connecting member comprises an elastic casing filled with a material having variable rigidity. This feature has the advantage that the material can have the properties of a flowable mass in the first operational state, because the material is contained by the elastic casing. With this, a particularly simple adjustment of a given spatial orientation of the trocar sleeve is possible. Furthermore, this feature has the advantage that the apparatus has a uniform and smooth surface, due to the elastic cover, preferably of silicone, which is simple to clean and to s
Dvorak Linda C. M.
Karl Storz GmbH & Co. KG
Ram Jocelyn
St. Onge Steward Johnston & Reens LLC
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