Vibration assisted needle device

Surgery – Diagnostic testing – Liquid collection

Reexamination Certificate

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Details

C600S567000, C600S568000

Reexamination Certificate

active

06702761

ABSTRACT:

FIELD OF THE INVENTION
A needle device, and more particularly, a biopsy needle device which is driven to vibrate in a direction along the axis of the needle to ease passage of the needle through tissue and the collection of a sample at a site of interest.
BACKGROUND OF THE INVENTION
When an abnormal area of tissue, such as a tumor, is discovered by non-invasive means, a tissue diagnosis is often required in order to determine the appropriate treatment. This requires that an adequate sample of tissue be removed from the patient for histopathological analysis. The tissue may be obtained in a variety of ways, such as surgical excision, fine needle aspiration biopsy or large needle core biopsy.
Fine needle aspiration biopsy, using needles with diameters of 20-22 Gauge, is minimally invasive. Typically, a biopsy needle with a stylet is inserted into the abnormal tissue, under the guidance of an imaging modality, such as ultrasound or magnetic resonance imaging (“MRI”). The stylet is then removed. A syringe is attached to the needle, suction is applied through the syringe and then the needle is manually thrust into and out of the tissue to capture and remove cellular material. However, rather than cutting the tissue to enable collection in the needle bore, the thin needle tends to displace the tissue, especially rigid malignant tissue. Therefore, only a small number of cells may be obtained. Even after repeated attempts, a sufficient amount of tissue might not be obtained. Displacement of tissue also alters the frame of reference defined by the imaging modality.
To improve yield, large bore needles, having diameters of 18-10 Gauge, have been used. However, the risk of damage to the tissues that the needle has to traverse to reach the area of pathology, as well as the risks of bleeding, infection and patient discomfort, rise with increasing needle thickness. Healing time may therefore be increased. Large needle core biopsy needles may also cause significant damage to certain organs, such as the lungs and the spleen. As with fine needles, displacement of movable tissues, such as breast tissue, is also a problem.
SUMMARY OF THE INVENTION
The problems encountered in the prior art are overcome in the devices, systems and methods of the present invention by reciprocating the biopsy needle along its longitudinal axis. Such reciprocation or vibration eases the advance of the needle through tissue to the site of interest, decreasing damage to the tissue. It is believed that the rapid movement of the needle decreases the friction between the needle and the surrounding tissue. The reciprocation of the needle also eases the penetration of the site of interest and the collection of tissue at the site of interest, with minimal displacement of the tissue, as the inertia of the tissue of the site of interest maintains the tissue essentially stationary as the tissue is penetrated by the rapidly moving needle. The present invention provides for greater tissue collection than that typically obtained by fine needle aspiration, without the risk of tissue damage and tissue displacement associated with the use of large bore needles. While fine needles are preferably used with the present invention, large bore needles may be used, as well.


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