Surgery – Instruments – Stereotaxic device
Reexamination Certificate
2001-10-03
2002-10-29
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Stereotaxic device
Reexamination Certificate
active
06471711
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for guiding a puncture needle for allowing the needle to precisely reach a target site in a subject or a patient (hereinafter referred simply to as “subject”) in accordance with a target determined by image data. The puncturing operation being percutaneously carried out with respect to a pectoral region or an abdominal part of the subject in accordance with a target determined by image data, particularly image data obtained in CT (computerized tomography) scanner and the like.
BACKGROUND OF THE INVENTION
In the case where a puncturing operation is percutaneously performed with respect to a pectoral region or an abdominal part of a subject in accordance with a target determined by image data obtained in CT (computerized tomography) scanner and the like, an examiner or an operator (hereinafter referred to simply as “examiner”) confirms a target site, decides a puncturing position, a depth, and a direction (a puncturing route) for a puncture needle, and manipulates the puncture needle so as to reach the target site from the surface of the subject body (hereinafter referred optionally to as “subject's body surface”) while confirming a needlepoint of the puncture needle under its image, besides the puncturing operation must be made while maintaining a parallel state with respect to the cross section of such CT image,
Particularly, the examiner is requested to reproduce the puncturing route determined in the image to perform the puncturing operation. Accordingly, it is an important point from a viewpoint of manipulation to be performed by the examiner how much exact puncturing operation.
In the case where manipulation for a puncturing operation with a needle is practiced clinically without employing any device for guiding such puncture needle, the operation is carried out in such that a position to be punctured in a subject is marked, a needle tube is calibrated as a navigation mark for a depth, CT-photographing is repeated for adjustment of a direction and necessity of puncturing exactly a target, and a needlepoint of the puncture needle is observed by a monitor under its image.
In this case, if it is difficult to capture exactly a target site and to puncture parallel the target site in conformity with a cross section of its image, such events wherein a needle does not reach a target site by a single try occur frequently. In such case, it is necessary for beginning again the puncturing operation. Furthermore, in a monitor observation during a puncturing operation, it is required to repeat photographing for confirming a position of the puncture needle, so that it is desired for an administration wherein an amount of exposure to radiation is reduced with respect to a subject, and for making an arrangement by which significant burden is not given to the subject by reducing a period of time for examination as much as possible.
In order to eliminate the above described disadvantages, devices for guiding puncture needle which are intended to apply to a pectoral region or an abdominal part of a subject have been proposed. They are, for example, a device provided with an angle gauge which is fixed to an examining table; or a device for holding a biopsy needle on a curved arm in a circular arc shape which is employed by fixing to an examining table (Japanese Patent Laid-Open No. 236633/1995); a device for guiding a puncture needle which is provided with a level, a protractor, and a guide plate for the puncture needle and which is employed by floating the same from an examining table on the basis of horizontal plane as its reference (Japanese Patent Laid-Open No, 127036/1987); or a device wherein a number of strings which are not allowed X-rays to pass through them are stretched in two stages with respect to a tetragonal cylindrical body and which has a holding section for a puncture needle being photographed together with a target site, whereby the target site can be determined on the extension from two points in a visible section (Japanese Patent Laid-Open No. 238248/1996); and the like.
When a puncture needle is pierced in accordance with each guiding mechanism by utilizing any of these devices for guiding puncture needle, it becomes possible to allow a needlepoint of the puncture needle to reach a target in conformity with a cross-sectional plane of its image at a certain degree, and further it is expected to reduce the number of times for photographing.
Recently, an image; can be observed real time while scanning continually sections with development of CT apparatus. Hence, manipulation can be performed while confirming always a needlepoint under CT transmission. Accordingly, it becomes possible to perform relatively easy a puncturing operation with high precision.
On the other hand however, since X-rays are continuously exposed in a gantry of a continuous CT scanning apparatus, an amount of exposure to X-rays is significantly restricted by a law as to prevention of radiation damage due to radioactive isotopes and relative laws and ordinances in practical manipulation, Moreover, an administration for direct exposure to radiation upon an examiner during his (or her) manipulation becomes a problem.
In order to solve such exposure problems, a device wherein a major detection needle is connected perpendicularly to a rod serving as a handle; and a needle holder composed of a needle holding section and a handle disposed in parallel to the needle holding section wherein the handle is disposed away 4 to 7 cm from the holding section (Japanese Patent Laid-Open No.140716/1997) have been proposed. When these devices are used, it is possible to avoid direct exposure to radiation with respect to fingertips of an examiner.
However, according to conventional devices for guiding puncture needle, in a device of the type which is fixed to an examining table, since a guiding device must be fixed to an exact position after deciding a target for puncturing with a needle, there is a problem of requiring a much time before starting a puncturing operation because of such troublesome fixing operation Particularly, if there is a movement of a subject's body during examiner's manipulation, the puncture needle deviates from the target site, and further there is a danger of bending or breaking of the puncture needle in the worst case, because the guiding device is fixed to the examining table. Furthermore, the circular arc-shaped device to be attached to an examining table involves also the same problems as that contained in the above described guiding device. In addition, the device contains a problem of large number of parts, and a problem of a complicated structure.
In a device provided with a level or the like, since it is used in a floating state from an examining table, problems relating to fixation of the above described devices are eliminated. However, it is required that the device must be kept horizontal during examiner's manipulation by the use of the level, In a practical use, there is clinically a rare case where a subject's body surface on which the device is to be placed is maintained in a horizontal state. Accordingly, the device must be kept horizontal by an assistant or the like, but it is difficult to maintain a horizontal state during examiner's manipulation.
In a tetragonally cylindrical device provided with strings which are not allowed X-ray to pass through the same, such a problem wherein the device must be kept horizontal during manipulation by an assistant or the like is eliminated, because the device can be used in such a situation that it has been attached to a subject's body surface, However, such device involves a complicated structure and the number of parts therefore increases.
Moreover, a device for a needle holder which is practiced under CT vision through according to a real time CT apparatus can prevent exposure to radiation upon an examiner, but a grip section is not directly connected with a needle, Further; since a puncturing operation is performed with holding the grip section
Irie Toshiyuki
Itai Yuji
Maruyama Masaru
Hakko Electric Machine Works Co., Ltd.
Robert Eduardo C.
Scully Scott Murphy & Presser
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