Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-11-03
2001-05-08
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S564000, C600S104000, C606S170000
Reexamination Certificate
active
06228039
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a device for performing endoscopic guided fine-needle biopsy.
In the medicine it is known that, to collect a tissue sample, a hollow needle is used to puncture tissue and to gain biological material for histological, cytological or genetechnological examinations.
As to the cytological examination, in particular, fine-needle biopsy is known. In this biopsy, cell material is collected by a thin hollow needle by means of suction. Usually the collection of the tissues and the positioning of the hollow needle are monitored with ultrasonic waves. The monitoring by the use of ultrasonic waves is necessary, particularly when it is necessary to collect the tissue from a small region which has been specified.
In case of percutaneous hollow-needle biopsy, the needle is pushed forward through the skin of the patient until it reaches the tissue from which a sample shall be collected. The percutaneous hollow-needle biopsy is suitable for collecting tissue which can be easily accessed, directly through the skin. Ordinary needles have a length of 6 to 10 cm and are monitored by means of an imaging method, such as ultrasonic or computer tomography. The efficiency of the tissue sampling and the efficiency of penetrating hardened tissue can be improved by abruptly pushing the needle if the needle is relatively short. The pushing of the needle can be assisted by a spring force.
Certain tissues are not suitable for being punctured with a percutaneous biopsy needle. This is because the needle cannot reach the tissue. For example, another tissue can block the insertion of the biopsy needle.
Hereto it has been known that a biopsy needle can also be guided through an echo-endoscope, to thereby collect tissues through a hollow organ (Hahlorgan). In this technique, the echo-endoscope possess not only functions as an optical monitor for the puncture, but also is a protecting sleeve and a means for guiding the needle over a long distance and positioning the needle at the sampling position.
The technique of echo-endoscopic fine-needle biopsy is employed to, for example, collect pancreasor lymphatic node tissue. The echo-endoscope which is appropriate for use in this technique has a passage for guiding the biopsy needle. The needle is inserted into the hollow organ, while being guided through the echo-endoscope, until it reaches the sampling position. At the sampling position, the needle is inserted into the tissue and moved back and forth, whereby a sample is separated from the tissue by virtue of a negative pressure. In order to obtain material in a sufficient amount for cytological or histological examination, the needle must be moved back and forth many times.
In this technique, the needle needs to be long enough to have access to the tissue to be sampled, through a hollow organ. This results in some drawbacks. The length of the needle must be greater than the length of the endoscope. For example, tissues must be sampled with needles about 160 cm long, or ten times or more as long as needles for use in percutaneous biopsy.
Some skill is required to operate endoscopes. For example, it is difficult to control the needle in the grip region of an endoscope, in the process of positioning an endoscope. This is true, especially when the needle must be guided along several curves, through a passage formed in the endoscope. The force which is necessary for moving the needle increases as the needle is guided along each curve, due to the frictional forces at the curves. The sum of the frictional forces may become considerable. The user must manually overcome the sum of frictional forces. This makes it difficult to perform a precise operation, causes the danger of breaking the needle, and may result in damage to the echo-endoscope which is a sensitive component.
In addition, the fine needle biopsy relating to echo-endosonography cannot be achieved at all when the tissue to be sampled has a certain hardness, as do pathologically hardened tissues. In this case, the needle is not inserted into the tissue. If the needle is inserted, the pressure applied to it will increase very much. Even in the best case, the needle or the endoscope connected to the needle may avoid contacting the tissue, but the endoscope may nevertheless be damaged.
Even if the tissue is easy to penetrate, the tissue sampled is often not satisfactory. This is especially disadvantageous, when the punctured tissue is intended for a cytlogical or histological examination. Thus, the biopsy needle must be moved back and forth several times to increase the amount of tissue sampled. Even if this technique is applied, it may not possible to sample tissue in a useful amount.
BRIEF SUMMARY OF THE INVENTION
The object of the present invention is to solve the above described problems and to provide an improved endoscopic biopsy device that can be used to sample even hardened or hard tissue.
The solution is achieved by automatically operating the needle and pre-biasing the needle by means of, for example, a spring. As soon as the spring is loosened, the needle thrusts forward into the tissue. By virtue of the inertia of the mass of the echo-endoscope, the needle passes through even hardened tissue. The high acceleration of the needle lessens the bending of the needle and overcomes the frictional forces.
More specifically, according to the device of the present invention, the needle pre-biased rushes forward after a release device provided on the pre-biasing device is operated.
The biopsy needle automated according to the invention can acquire high quality samples, and can penetrate even hardened tissue which cannot be sampled through an endoscope by the use of the conventional manual biopsy needle. As described above, if a manual biopsy needle is used to sample hardened tissue, there is a risk that either the needle or the endoscope will be damaged.
Further, the use of the biopsy needle of the invention results in a considerable increase in the amount of tissues sampled and avoids the undesirable, repeated reciprocating motion required with conventional techniques.
In this case, the needle in the passage formed in the echo-endoscope can be surrounded by a protecting sleeve. Preferably, the sleeve is made of a spiral-type sheath that can be moved independently of the needle. The movable sleeve protects and reinforces the needle and can position the needle appropriately, even after the needle has moved out of the passage provided in the echo-endoscope.
In order to reliably move the biopsy needle forwards and to prevent the pre-biasing device from projecting, the housing of the pre-biasing device can be set into screw engagement with the opening of the passage provided in the echo-endoscope. Adjusting means may precisely adjust the position of the needle and the forward movement of the pre-biasing device.
The device according to a specific embodiment of the invention can also be used for conventional manual sampling of tissue, achieved by reciprocating a biopsy needle, in addition to the function of automatically sampling tissues. Thus, it is possible to sample tissues by (manually) moving the needle back and forth or by (automatically) thrusting the needle forward, before or during the sampling of tissues.
Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out hereinafter.
REFERENCES:
patent: 2725878 (1955-12-01), Reiter
patent: 4572201 (1986-02-01), Kondo et al.
patent: 4578061 (1986-03-01), Lemelson
patent: 4700694 (1987-10-01), Shishido
patent: 4763667 (1988-08-01), Manzo
patent: 4982724 (1991-01-01), Saito et al.
patent: 5060658 (1991-10-01), Dejter, Jr. et al.
patent: 5234426 (1993-08-01), Rank et al.
patent: 5342296 (1994-08-01), Persson et al.
patent: 5342394 (1994-08-01), Matsuno et al.
patent: 5470308 (
Frishauf, Holtz Goodman, Langer & Chick, P.C.
Marmor II Charles
Winakur Eric F.
LandOfFree
Biopsy device does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Biopsy device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Biopsy device will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2562103