Biopsy needle instrument

Details Biopsy needle instrument Biopsy needle instrument

2001-11-13

2004-02-10

Marmor, Charles (Department: 3736)

Surgery

Diagnostic testing

Sampling nonliquid body material

C600S564000, C606S167000

Reexamination Certificate

active

06689072

ABSTRACT:

The present invention relates in general to the field of medical biopsy instruments, and more particularly, to such instruments for use in fine needle biopsy of human or animal tissue for medical diagnostics and the like.
BACKGROUND OF THE INVENTION
Biopsy instruments are often used to obtain tissue samples for microscopic examination to test for malignancy or other diseases and abnormalities. Generally, biopsies may be guided by either stereotactic means, CAT scan or ultrasound means. Image-guided biopsy procedures are particularly useful for non-surgical diagnosis of benign and malignant masses. The biopsy itself may be either a core biopsy or a fine needle aspiration biopsy. For example, an instrument for performing percutaneous biopsy procedures and collection of soft tissue is disclosed in Ritchant, et al., U.S. Pat. No. 5,649,547.
Other currently used biopsy instruments and methods include those disclosed in Siczek, et al., U.S. Pat. No. 5,415,169 and Assa, U.S. Pat. No. 5,240,011, Siczek, et al. and Assa each disclose a motorized biopsy needle positioner employed in a mammographic needle biopsy system for receiving coordinate information representative of an identified point of interest within the patient's captive breast under examination and automatically positioning a biopsy needle in accordance with the coordinate information to permit insertion of the biopsy needle to the identified point of interest.
Additionally, Clement, et al., U.S. Pat. No. 5,368,045 discloses a handheld biopsy needle instrument employing combined stylets and cannulas capable of taking multiple specimens while the other hand is free to manipulate an ultrasound probe. The stylet and cannulas are spring loaded, which upon firing, will penetrate the tissue for obtaining a biopsy specimen. A similar biopsy instrument having a plurality of stylets and cannulas which can be controlled independently for capturing a plurality of discreet specimens at a controlled depth is disclosed in Chin, et al., U.S. Pat. No. 5,415,182. See also Akerfeldt, U.S. Pat. No. 4,944,308.
Fine needle aspiration biopsy is often performed on a potentially malignant mass for confirmation of diagnosis prior to surgery, on more than one mass where multi-focal or multi-centric malignant disease is suspected, on a suspected benign lesion such as a fibroadenoma, where there is ambivalence about follow-up versus excision, or on an ultrasound imaged structure with features unlike a simple cyst. Among the benefits of fine needle aspiration when compared with other biopsy procedures are that it is less invasive, requires no incision, causes minimal discomfort, takes less time and costs considerably less. A discussion of fine needle aspiration is disclosed in the article Fine Needle Aspiration, Kathleen M. Harris, M. D., FACR, pp. 101-105.
Suction and capillary methods of aspiration have been successful on the breast. For suction aspiration, a syringe in a resting position is attached to a sampling needle. Suction is created by pulling the plunger of the syringe. In the capillary method, a syringe is not used and suction is not applied. With both methods, up to the present time the sampling needle is manually moved back and forth rapidly by the physician within the area to be studied. The needle is further angled in multiple directions to sample a cone-shaped area within the area to be studied. In the suction method, the suction should be maintained until material is visible in the plastic needle hub, or for a minimum of twenty up-and-down motions in varying directions. This method is described further in Interventional Breast Procedures, edited by D. David Dershaw, pp. 91, 94 and 95. A similar technique is described in General Ultrasound, Ed., Carol A. Mittelstaedt, M. D., pg. 18. The technique is also described in Interventional Breast Ultrasonography, Ellen B. Mendelson, M. D., pp. 57-76. Another similar technique is that discussed in Thyroid and Parathyroid, pg. 107.
Until now, and as described in the foregoing references, fine needle aspiration biopsies have been performed manually. Such a procedure involves manually thrusting a needle alone or a needle attached to a syringe, with or without suction. The procedure is generally random in that the depth of the thrusts, number of thrusts, the area covered and the force used are done in a very haphazard way. For example, one thrust could be 5 millimeters, while another could be 2 millimeters and so forth.
A significant limitation with random depth is that when a lesion is very small in diameter, there are occasions where none or a few of the thrusts obtain the necessary tissue sample. One of the thrusts may be directed to a lesion, but may bypass the lesion completely as a result of a lack of consistent direction of the thrusts. Random depth results in a significant amount of fine needle aspiration biopsies retrieving an insufficient amount of tissue with which to do an appropriate diagnostic evaluation. If the number of thrusts is limited, this compounds the problem further and increases the chances of missing the lesion.
Another limitation of the prior method is lack of significant thrusting energy. The force behind the thrust may be variable, and many may be insufficient enough to pierce the outer margins of certain lesions, especially fibroadenomas. The needle can potentially bounce off the fibroadenoma or push it aside rather than pierce the outer margin and obtain the necessary tissue.
Many fibroadenomas are currently surgically excised without any attempt to perform a fine needle biopsy. The cost of excisional biopsies are multiple times the cost of a fine needle aspiration biopsy. Significant medical financial resources could be saved by performing fine needle aspiration biopsies instead of excisional biopsies. Providing an improved method and an automated biopsy instrument for performing fine needle aspiration biopsies would reduce the need for excisional biopsies together with their inherent risks.
There is disclosed in Dejter, Jr., et al., U.S. Pat. Nos. 5,060,658 and 4,989,614 a medical instrument for fine needle aspiration biopsies of the prostate only. The biopsy instrument includes a needle having an opening which can be occluded by a stylet during both the penetration and withdrawal stage of an aspiration cycle during the biopsy procedure. After penetration of the target tissue, the needle is reciprocated a predetermined number of times as determined by the desired cytological sample yield. During the reciprocating procedure, the needle opening remains unoccluded by withdrawal of the stylet. Tissue sample is collected in a syringe under vacuum. After sufficient tissue sample has been collected, the stylet is returned to its forward position, thereby occluding the needle opening prior to withdrawal of the needle from the patient. The biopsy instrument is opened in order to remove the syringe containing the collected tissue sample for cytological analysis.
Naslund, U.S. Pat. No. 4,605,011 discloses a biopsy instrument for taking samples of cells of small tumors using fine needle puncturing techniques. The biopsy instrument includes a hand grip having a syringe provided with a removable cannula. The cannula is connected to a motor which is operative for driving the cannula in an oscillating, recipricatory motion. The motor is constructed as an electromagnet having pole elements, which when energized, cause reciprocal motion of a pole element which is coupled to the cannula. The cannula is connected to a container which is placed under vacuum for drawing a tissue sample from the cannula during the biopsy procedure. This instrument is not used without suction.
Patipa, et al., U.S. Pat. No. 4,644,952 discloses a surgical operating instrument provided with a needle which can be reciprocated by means of a cam and cam follower arrangement. The needle is attached to one end of a shaft, the other end supporting a laterally extending cam follower. The cam follower is captured interiorly within a cam between two opposing cam surfaces. The cam is rotated by a motor thereby eff

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