Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-11-20
2003-07-15
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S568000, C600S567000, C606S167000
Reexamination Certificate
active
06592530
ABSTRACT:
FIELD OF INVENTION
This invention relates generally to a biopsy instrument; a device for removing a sample of tissue from a human being or an animal. More particularly, the invention relates to an automated biopsy instrument in which an outer cannula is driven over an inner stylet to obtain the tissue sample.
BACKGROUND OF INVENTION
The procedure known as biopsy, or the removal of samples of human and animal internal tissue, has been for many years a favored method for the nonsurgical diagnosis of tissue. Using biopsy needles one can take out samples from deeply located organs, such as the liver or the kidneys. This kind of sampling, is usually carried out in such a way that a doctor inserts a needle assembly through the skin and to the desired sampling location. Several kinds of biopsy needles are employed to biopsy the internal organs. One of the most commonly used needle assemblies comprises a slidably provided inner needle within a hollow outer needle. Using this kind of instrument, sampling has been performed in a two-step manual technique in which the outer hollow cutting cannula telescopically receives the inner stylet which is slidable between retracted and extended positions relative to the cannula. The sylet contains a specimen receiving slot near its sharpend distal end. In performing the first step of the technique, the physician places the tip of the needle (with the stylet retracted inside the cannula) against the tissue mass to be sampled and manually drives the stylet forward into the tissue mass. To carry out the second step, the physician manually drives the cutting cannula forwardly over the stylet, thereby severing a tissue sample and retaining it within the stylet slot inside the cannula's hollow interior. Then the entire needle assembly containing the collected tissue sample is withdrawn, whereafter the sample can be taken out and analyzed.
Examples of manually operated biopsy needles of this general type are disclosed in U.S. Pat. No. 4,700,014, issued Jul. 15, 1986 to D. Beraha for “Transrectal Prostate Biopsy Device and Method”, and U.S. Pat. No. 3,477,423, issued Nov. 11, 1969 to L. K. Griffith for “Biopsy Instrument”. Actually many physicians utilize a TRU-CUT® biopsy needle available from Travenol Laboratories, Inc. of Deerfield, Ill. that is described in above mentioned U.S. Pat. No. 3,477,423 to Griffith.
Such manually operated two-step devices are awkward to manipulate, and the tissue samples obtained may often be unsatisfactory. The depths to which the stylet and the cannula are driven into the tissue mass must be carefully controlled for accuracy and efficiency. Caution is required, as well, in applying the force with which the stylet and the cannula are plunged forward. Too little force may not sever the tissue sample from the mass. Too much force may cause unnecessary damage to the surrounding vital tissues.
Several automated biopsy instruments have been invented to improve the manual procedure and make it easier. The inventive idea resides in placing the needle assembly in a box, in which box there are provided propelling means for propelling the outer and/or inner needles, such that they carry out the above mentioned coordinated movements when the needle assembly has been located to the correct sampling position in the body. The needles are brought to carry out the desired movements in that the operator actuates a release mechanism outside of the box. The example of the automated devices are seen in U.S. Pat. No. 4,767,684, issued May 26, 1987 to H. G. Leigh for “Biopsy Device”. It discloses a movable stylet telescopically received in a hollow movable cannula, both the stylet and the cannula being mounted to hubs within a pistol-style grip. In use the stylet is first manually advanced into the tissue and the cannula is then driven over the stylet by depressing a trigger.
A similar instrument designed by D. N. Mehl, through U.S. Pat. No. 4,733,671, issued Mar. 29, 1988, includes a pistol-style squeezable hand grip for single hand operation. A spring tensioned sliding cannula, including a configured cutting edge, actuates by a squeeze trigger and cam arrangement to slide over a fixed position stylet for entry into a tissue sample area.
Another automated device is found in U.S. Pat. No. 4,799,154, issued Oct. 13, 1987 to P. G. Lindgren for “Tissue Sampling Device”. It is composed of a mechanism in which a release button is depressed to cause a spring-loaded stylet to be advanced into the tissue mass. The forward movement of the stylet also triggers the delayed release of a spring-loaded outer cannula, which slides over the stylet to sever the tissue sample.
U.S. Pat. No. 4,924,878, issued May 15, 1990 to J. E. Nottke for “Actuating mechanism for biopsy needle ” and U.S. Pat. No. 4,958,625, issued Sep. 25, 1990 to J. S. Bates for “Biopsy needle instrument”, disclose two other automated devices with sequential movement of the needles.
In any event, the various automated biopsy instruments presently known tend to be heavy and difficult to manipulate. Such limitations diminish the physician's control over the instrument and the precision with which biopsies may be performed. These instruments may be subject to inadvertent movement or torque which may, in turn, subject the patient to unnecessary trauma and risk.
Extensive bleeding can occur as a result of tissue resecting, which can lead to dangerous bleeding and complications. The idea of creating this device arrose after a complicated liver biopsy procedure. The patient developed exsanguinating blood loss through the peritoneum which led to an emergency laparatomy. This complication might be seen in tissue sampling of the visceral organ and is especially encountered in patients with bleeding diathesis. In an effort to remedy these problems, various techniques have been developed. For example, U.S. Pat. No. 3,598,108, issued Aug. 10, 1971 to K. Jamshidi for “Biopsy technique and biopsy device”, discloses a biopsy technique and device involving the insertion of a biopsy needle into the tissue from which the specimen is to be taken, the needle having a sleeve member and the stylet therein, the stylet being removed and the biopsy being collected in the sleeve which is also thereafter removed. A heat transfer means such as a microcauter or a cryoprobe is inserted through the needle to project from the distal end thereof, which serves to cauterize the biopsy track as the needle and heat transfer means are removed as a unit.
In addition, U.S. Pat. No. 5,928,163, issued Jul. 27, 1999 to T. W. Roberts for “Biopsy sampler”, discloses a “hot” biopsy procedure, using surgical forceps in which the jaws are electrodes (bipolar or monopolar). After the tissue sample is resected, the forceps are brought in contact with tissue remaining at the resecting site and RF energy is applied to the forceps to cause current to flow (i.e., cauterization) through the resecting site tissue to coagulate the tissue and stop the bleeding. Often, RF energy is applied to the forceps during resecting to help cut the tissue sample as well.
U.S. Pat. No. 5,810,806, issued Sep. 22, 1998 to M. A. Ritchart for “Methods and devices for collection of soft tissue”, employs a combination of an electrosurgical cutting and a vacuum retrieving element, for sampling tissues.
U.S. Pat. No. 5,607,389, issued Mar. 4, 1997 to Edwards, et al. for “Medical probe with biopsy stylet” discloses several instruments for tissue collection. One of those embodiments includes a biopsy knife device in conjunction with an electromagnetic emitter for selective tissue sampling and electromagnetic heat ablation, or both.
U.S. Pat. No. 6,036,656, issued Mar. 14, 2000 to Slater, et al. for “jaw assembly having progressively larger teeth and endoscopic forceps instrument incorporating same” shows a design of an endoscopic forceps coupled to an electrocautery voltage supply for electrocoagulation of the biopsied tissue. Also U.S. Pat. No. 5,458,598, issued Oct. 17, 1995 to Feinberg for “cutting and coagulating forceps” discloses another type of forceps coup
Farhadi Ashkan
Hindenburg Max F.
Marmor II Charles
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