Method of manufacturing a needle assembly for use with a biopsy device

Abstract

An improved process for manufacturing a biopsy needle assembly is provided. The process may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube for receiving a cutter, wherein the elongated tube comprises a proximal portion and a distal portion; forming a hole in the exterior surface of the elongated tube; and applying a coating of material over the elongated tube to form a lumen for receiving vacuum on the exterior surface of the elongated tube, wherein the hole in the exterior surface of the elongated tube provides communication between an interior of the elongated tube and an interior of the lumen. In one version, the elongated tube may be placed in a mold configured to form the vacuum lumen when material is injected into the mold. A proximal hub may advantageously be formed by overmolding.

Description

FIELD OF THE INVENTION [0001] The present invention is related generally to biopsy devices and, more particularly, to an improved process of manufacturing a needle assembly for use with a biopsy device for acquiring a tissue sample. BACKGROUND OF THE INVENTION [0002] The diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions, and other disorders has long been an area of intense investigation. Non-invasive methods for examining tissue include palpation, thermography, PET, SPECT, Nuclear imaging, X-ray, MRI, CT, and ultrasound imaging. When the physician suspects that tissue may contain cancerous cells, a biopsy may be done either in an open procedure or in a percutaneous procedure. For an open procedure, a scalpel is used by the surgeon to create a large incision in the tissue in order to provide direct viewing and access to the tissue mass of interest. Removal of the entire mass (excisional biopsy) or a part of the mass (incisional biopsy) is performed. ...

AI Technical Summary

Benefits of technology

[0009] The process of the current invention overcomes the above-noted and other deficiencies of the prior art by providing a process for manufacturing a biopsy needle device that reduces the number of components that must be separately manufactured and assembled, thereby reducing the cost of manufacturing the biopsy needle device while maintaining the necessary biomechanical properties.

[0010] In one aspect consistent with the present invention, a process of manufacturing a biopsy needle may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube that has a proximal and distal portion, wherein the elongated tube may be configured to receive a cutter; forming a hole in the exterior surface of the elongated tube; and applying a coating of material over the elongated tube to form a lumen for receiving vacuum on the exterior surface of the elongated tube, wherein the hole in the exterior surface of the elongated tube may be adapted to provide communication between an interior of the elongated tube and an interior of the lumen. This process advantageously allows the vacuum lumen to be formed over the elongated tube without requiring separate manufacturing and assembly steps, thus reducing assembly costs.

[0011] In another version, the process of manufacturing the biopsy needle device may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube, wherein the elongated tube may be adapted to receive a cutter and may further comprise a proximal portion and a distal portion; forming a hole in the exterior surface of the elongated tube; and placing the elongated tube in a mold and injecting the mold with a material, wherein the mold may be configured such that the material forms a lumen for receiving vacuum on the exterior surface of the elongated tube, and wherein further the hole in the exterior surface of the elongated tube may be adapted to provide communication between an interior of the elongated tube and the interior of the lumen. This version advantageously provides for the formation of a vacuum lumen on an elongated tube by overmolding a coating of material onto the elongated tube, avoiding the need to separately manufacture the vacuum lumen and then attach it to the elongated tube. Further, this process may provide for a stronger attachment between the vacuum lumen and the elongated tube than some previously known methods of attachment of the two components.

Problems solved by technology

The type of biopsy used depends mainly on various factors present in the patient, and no single procedure is ideal for all cases.

While biopsy needles of the type described above are useful in obtaining tissue samples, the processes known in the art for manufacturing these needles are often expensive and labor-intensive due to the number of components and steps involved.

These sharpened tips often have small components and / or features that require significant time and expense to make and attach to the needle.

Even if a more reliable method of attaching the mounting component to the needle is used, such as induction heating or heat staking, such methods still involve the added expense necessitated by the extra assembly equipment as well as the steps of manufacturing the mounting component and attaching it to the needle.

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