Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2001-09-28
2004-03-30
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06712774
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates, in general, to an improved surgical biopsy instrument and, more particularly, to a lockout mechanism for use in a surgical biopsy instrument.
BACKGROUND OF THE INVENTION
The diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions, and other disorders has long been an area of intense interest in the medical community. Non-invasive methods for examining tissue and, more particularly, breast tissue include palpation, X-ray imaging, MRI imaging, CT imaging, and ultrasound imaging. When a physician suspects that tissue may contain cancerous cells, a biopsy may be done using either an open procedure or in a percutaneous procedure. In an open procedure, a scalpel is used by the surgeon to create an incision to provide direct viewing and access to the tissue mass of interest. The biopsy may then be done by removal of the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). In a percutaneous biopsy, a needle-like instrument is inserted through a very small incision to access the tissue mass of interest and to obtain a tissue sample for examination and analysis. The advantages of the percutaneous method as compared to the open method are significant: less recovery time for the patient, less pain, less surgical time, lower cost, less disruption of associated tissue and nerves and less disfigurement. Percutaneous methods are generally used in combination with imaging devices such as X-ray and ultrasound to allow the surgeon to locate the tissue mass and accurately position the biopsy instrument.
Generally there are two ways to percutaneously obtain a tissue sample from within the body, aspiration or core sampling. Aspiration of the tissue through a fine needle requires the tissue to be fragmented into small enough pieces to be withdrawn in a fluid medium. Application is less intrusive than other known sampling techniques, but one can only examine cells in the liquid (cytology) and not the cells and the structure (pathology). In core biopsy, a core or fragment of tissue is obtained for histologic examination which may be done via a frozen or paraffin section. The type of biopsy used depends mainly on various factors and no single procedure is ideal for all cases.
A number of core biopsy instruments which may be used in combination with imaging devices are known. Spring powered core biopsy devices are described and illustrated in U.S. Pat. Nos. 4,699,154, 4,944,308, and Re. 34,056. Aspiration devices are described and illustrated in U.S. Pat. Nos. 5,492,130; 5,526,821; 5,429,138 and 5,027,827.
U.S. Pat. No. 5,526,822 describes and illustrates an image-guided, vacuum-assisted, percutaneous, coring, breast biopsy instrument which takes multiple tissue samples without having to re-puncture the tissue for each sample. The physician uses this biopsy instrument to “actively” capture (using the vacuum) the tissue prior to severing it from the body. This allows the physician to sample tissues of varying hardness. The instrument described in U.S. Pat. No. 5,526,822 may also be used to collect multiple samples in numerous positions about its longitudinal axis without removing the instrument from the body. A further image-guided, vacuum-assisted, percutaneous, coring, breast biopsy instrument is described in commonly assigned U.S. application Ser. No. 08/825,899, filed on Apr. 2, 1997 and in U.S. Pat. Nos. 6,007,497; 5,649,547; 5,769,086; 5,775,333; and 5,928,164. A handheld image-guided, vacuum-assisted, percutaneous, coring, breast biopsy instrument is described in U.S. Pat. No. 6,086,544 and in U.S. Pat. No. 6,120,462. The instrument described therein moves drive motors and other electronic components into a control unit separate from and remotely located from the biopsy probe. Biopsy probe cutter rotational and translational motion is transferred from the motors in the control unit to the biopsy probe via flexible coaxial cables. This arrangement greatly improves the cleanability of the reusable hardware that remains in close proximity to the biopsy site as well as improves the life and durability of the electric motors and electronic components now remotely located from the biopsy probe. The biopsy instrument described and illustrated in U.S. Pat. No. 6,086,544 and in U.S. Pat. No. 6,120,462 was designed primarily to be a “hand held” instrument to be used by the clinician in conjunction with real time ultrasound imaging. Several image-guided, vacuum-assisted, percutaneous, coring, breast biopsy instruments are currently sold by Ethicon Endo-Surgery, Inc. under the Trademark MAMMOTOME™.
The majority of breast biopsies done today, however, utilize an x-ray machine as the imaging modality. Using x-ray requires that the biopsy instrument be affixed to the x-ray machine by some type of bracket arrangement. Since the biopsy instrument is fixed to a portion of the x-ray machine there is now a need for a means to conveniently rotate the biopsy probe once it is advanced into the breast in order to accurately position the vacuum port at the distal end of the probe.
In U.S. Pat. No. 5,649,547 a biopsy device is disclosed which includes a drive assembly containing a stored energy probe “firing” mechanism. This firing mechanism is used by the clinician to rapidly advance the biopsy probe piercing element into the patient during a biopsy procedure, which is necessary to penetrate the dense tissue comprising many lesions. Also disclosed in U.S. Pat. No. 5,649,547 is a biopsy device which includes a drive assembly containing a stored energy probe “firing” mechanism. This firing mechanism is used by the clinician to rapidly advance the biopsy probe piercing element into the patient during a biopsy procedure, which is necessary to penetrate the dense tissue comprising many lesions. The firing mechanism in U.S. Pat. No. 5,649,547 includes a probe firing safety system intended to minimize the risk of the biopsy probe being fired prematurely or accidentally. The system includes a “pierce” button and a “safety” button, both of which are utilized in the process of firing the biopsy probe piercing element into the patient. The pierce button is attached to a latch, which interfaces with the stored energy firing mechanism. By depressing the pierce button, stored energy in the firing mechanism is released causing the biopsy probe to rapidly advance distally into the patient. The safety button is attached to a rod and is free to slide in a linear fashion. In the “on” position, the rod is placed in interference with the travel of the pierce button thus preventing accidental firing of the biopsy probe. Conversely, the safety button can be placed by the clinician in the “off” position, moving the rod clear of the pierce button and allowing for full travel of the pierce button to effect the firing of the biopsy probe.
It would, therefore, be advantageous to design an image-guided, vacuum assisted, percutaneous, coring, breast biopsy instrument which may be conveniently mounted to an x-ray machine, and incorporate into it a safety system that is located in an area that can be easily viewed and accessed by the user irrelevant of the position of the user to the instrument during a biopsy procedure. It would further be advantageous to design an image-guided, vacuum assisted, percutaneous, coring, breast biopsy instrument which may be conveniently mounted to an x-ray machine in which the safety system is biased to the “on” or safe position, to eliminate the risk of the safety being unknowingly positioned to the “off” position. It would further be advantageous to design an image-guided, vacuum assisted, percutaneous, coring, breast biopsy instrument which may be conveniently mounted to an x-ray machine in which the safety system operates in a non-linear motion, is biased to the on or safe position, and is located immediately adjacent to the pierce button further improving the convenience of activating the firing mechanism to the user while reducing the risk of the biopsy probe being fired unintentionally.
SUMMARY OF THE INVENTION
Forester Craig F.
Garrison William A.
Voegele James W.
Hindenburg Max F.
Szmal Brian
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