Tumortherapy device and method

Surgery – Diagnostic testing – Sampling nonliquid body material

Reexamination Certificate

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Reexamination Certificate

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06238355

ABSTRACT:

The present invention claims priority to German patent application 198 06 693.7, filed Feb. 16, 1998, the entire disclosure of which is incorporated herein by reference.
FIELD OF THE INVENTION
The present invention is directed to minimally invasive surgical procedures. Specifically, the invention is directed to minimally invasive devices and methods for removal of a consolidated tissue mass from a dense tissue.
BACKGROUND OF THE INVENTION
Generally, solidated tissue masses, such as a tumor, which are situated deeply in a dense tissue have to be removed by an open surgical cut down through the dense tissue and around the consolidated mass. Such tumors include, for example, tumors of the breast, prostate, liver, muscle and fatty tissue. Presently, there are no minimally invasive systems to access the tumor for removal. The advantage of minimally invasive procedures performed in body cavities, for example, laparoscopy and arthroscopy, are well known.
Using a minimally invasive “key hole” method for tumor removal for accessing the tumor through a small incision in a dense tissue could reduce tissue trauma and pain and enhance patient recovery time.
SUMMARY OF THE INVENTION
The present invention provides minimally invasive systems for removal of consolidated tissue masses, such as tumors or other pathological tissues, located deep to the surface of a dense tissue. In general, the present invention is directed to a system of telescoping needles and cannulas. In some embodiments, the operation of a system of the invention can be facilitated by guidance of MRI visualization.
Throughout the present disclosure, examples are provided for illustration purposes. The examples are not intended to limit the invention. Thus, for example, when a device or method is described with regard to breast tissue or a tumor, it will be appreciated that the procedure is equally applicable to other tissues as further described below.
As used herein, a “needle” refers to an elongate hollow or solid centered body having a proximal end and a distal end. The distal end is the end directed toward the patient and the proximal end is the end facing the operator during use. A needle of the invention includes a sharp distal end which can pierce, cut or penetrate a tissue.
As used herein, a “cannula” refers to an elongate hollow body having a proximal end and a distal end. The proximal and distal end are as defined above. In some embodiments, a cannula of the invention can include a mechanism for excising or cutting a consolidated tissue mass at the distal end.
The invention provides for deep dissection of a dense tissue by step by step (incremental) mechanical widening or separation of the tissue. Generally, a device disclosed herein includes a telescoping needle system comprising an inner guiding needle, a system of one or more tissue separating needles to widen, stretch or otherwise separate the tissue, and an outer needle which defines an operating lumen. As used herein, the “operating lumen” is the lumen of the outermost needle used to perform a procedure of the invention. In some embodiments, the inner guiding needle can be a biopsy device. In one simple embodiment, only a single needle with a cone-shaped tip is inserted into the tissue so that it is widened and stretched. However, generally the invention provides a plurality of telescoping needles which are inserted sequentially into the dense tissue to widen the tissue step by step.
In a preferred embodiment, the outer needle includes an operating lumen having a longitudinal slit. The longitudinal slit includes a first and second lateral edge that move apart from one another when widening needles are inserted within the operating lumen of the outer needle, thus increasing the diameter of the operating lumen. In one embodiment, after placement, the operating lumen of the outer needle can be reduced in size to peripherally compress a consolidated tissue mass when the separating needles within the operating lumen of the outer needle are removed in a proximal direction. Thus, when the outer hollow needle has been placed around a tumor, for example, it can press the tumor and hold it fast in its lumen.
Such a held fast tumor can be removed with various cutting instruments. In one embodiment, a tumor can be pressed and cut out. Typically, if the tumor was in slack tissue, a cutting instrument may not be able to grasp it.


REFERENCES:
patent: 5197484 (1993-03-01), Kornberg et al.
patent: 5249583 (1993-10-01), Mallaby
patent: 5280427 (1994-01-01), Magnusson et al.
patent: 5830219 (1998-11-01), Bird et al.

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