Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-12-28
2003-04-01
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06540695
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the field of surgical biopsy instruments and methods. More specifically, it relates to devices and methods for electrosurgically accessing a pathologically suspect tissue mass within a patient's body, anchoring the device relative to the suspect tissue, and cutting tissue so as to isolate the suspect tissue and to facilitate the taking of a biopsy sample of the tissue mass, as well as to facilitate subsequent surgical procedures in the region of the tissue mass.
BACKGROUND OF THE INVENTION
In diagnosing and treating certain medical conditions, such as potentially cancerous tumors, it may be desirable to perform a biopsy, in which a specimen of the suspicious tissue is removed for pathological examination and analysis. In many instances, the suspicious tissue is located at a subcutaneous site, such as inside a human breast. To minimize surgical intrusion into a patient's body, it is desirable to be able to insert a small instrument into the body to gain access to the desired location for inspection and for extraction of a biopsy specimen.
Body tissue is often deformable, so that insertion of a needle or other device into a patient's tissues will often deform or displace the tissue through which the needle or other device moves. Tissues of interest, such as nodules, masses, tumors and the like, which are typically the desired targets of a biopsy sample, may be readily displaced, pushed aside or otherwise deformed during biopsy procedures, making it likely that some or all of the desired target tissue may be missed during the biopsy procedure, thereby increasing the likelihood of misdiagnosis of the condition that led to the need for the biopsy.
In extraction of a biopsy specimen with a probe, it may be desirable to anchor the probe in a desired position so as to insure th at the probe remains in a proper position relative to the suspect tissue during manipulations and activities before and during the actual acquisition of the biopsy sample. In addition, it may be desirable to isolate tissue from neighboring healthy tissue in order to ensure that no diseased or abnormal tissue remains outside the sampled volume. Thus, the volume of tissue isolated may be larger than the minimum necessary so as to obtain margins of tissue free of disease for pathological diagnosis.
Electrosurgical techniques have been used in a variety of circumstances, including certain types of biopsy procedures. In electrosurgery, high frequency electrical energy is applied through a primary electrode to patient tissue. The electrical energy flows through the tissue to a return electrode that is in contact with the patent's tissue. Typically, the return electrode is attached to the patient at a point remote from where the primary electrode contacts the tissue. The tissue adjacent the primary electrode is ablated, to form an opening in the tissue.
When electrically activated, the electrode ablates the tissue adjacent the electrode, to produce a tissue opening which provides access to tissue to be taken in a biopsy sample. Guidance of the electrode tip to the desired site within a patient's body may be through stereotactic, radiological, ultrasonic, magnetic resonance imaging (MRI), or other means. However, there is frequently a delay between the positioning of the device and the taking of the biopsy sample, so that the device or tissue may move and prevent acquisition of the desired tissue. Accordingly, there is need in the art for means to mark a target site within a patient's body and for means to anchor the biopsy device in a proper location.
The tissue to be sampled or removed from the patient will often comprise a volume larger than the volume of the biopsy probe to obtain disease-free margins for pathological diagnosis. Accordingly, means for obtaining tissue samples larger than the probe itself are desired. In addition, it is of clinical interest to determine the extent of a diseased or abnormal portion of the tissue, and it is often desired that a border of normal tissue, surrounding any abnormal tissue present, be removed as well. It is further desired that the tissue to be removed be isolated from the body to prevent migration of diseased or abnormal tissue into other locations of the patient's body.
Accordingly, there is need in the art for devices and methods for accessing a desired site within a patient's body without displacing target body tissue, for anchoring devices at a desired site to prevent movement of such devices after arrival at a desired site, for isolating tissue, and for taking biopsy specimens from a patient.
SUMMARY OF THE INVENTION
The present invention is directed to systems, devices and methods for accessing target tissue within a patient, for isolating a body of target tissue from its supporting bed, for performing a lumpectomy, for performing a biopsy, and for obtaining biopsy tissue. Accordingly, the present invention provides systems, devices and methods providing access to a desired subcutaneous site for target tissue within a patient's body and for isolating such target tissue from a supporting tissue bed.
In one embodiment, a device having features of the invention has an elongated shaft having a distal end, a proximal end and a longitudinal axis. An electrosurgical electrode is secured to the distal end of the shaft with a first electrical conductor extending within the shaft having a distal end electrically connected to the electrosurgical electrode and a proximal end configured to be electrically connected to a high frequency electrical power source. An anchoring mechanism is located proximal to the distal end; and a side-cutting mechanism having a cutting element configured to be rotated about the longitudinal axis of the shaft and thereby isolate a body of target tissue.
In another embodiment, the invention is a biopsy device for obtaining target tissue within a patient. In such an embodiment, it has an elongated shaft that has distal and proximal ends and a longitudinal axis; with an electrosurgical electrode secured to the distal end of the shaft. A device of this embodiment also has an electrical conductor extending within the shaft that is electrically connected at opposite ends to the electrosurgical electrode and to an electrical power source. The device also has an anchoring mechanism and a side-cutting mechanism having a cutting element. The cutting element is configured to be rotated about the longitudinal axis of the shaft and so to isolate a body of target tissue.
In yet a further embodiment, the invention is a device for performing a lumpectomy in a patient's breast. I t has an elongated shaft with an electrosurgical electrode secured to the distal end of the shaft and an electrical conductor extending within the shaft that is electrically connected to the electrosurgical electrode and to an electrical power source. The device of this embodiment has an anchoring mechanism located and a side-cutting mechanism having a cutting element that can be rotated about the longitudinal axis of the shaft to isolate a body of target tissue for removal.
In another embodiment, the invention provides a method for accessing target tissue at a desired site within a patient and isolating a body of target tissue. This method includes the steps of providing a device of the invention, contacting a patient's body with the device, and supplying high frequency electrical current to the electrical electrode while advancing the device into the patient and through the site of target tissue. The method also includes steps of an anchoring mechanism to penetrate the surface of the target tissue in order to fix the device at the target tissue site. In addition, the method provides for expanding the cutting element of the side-cutting mechanism into the target tissue and rotating the cutting element to cut a body of target tissue.
In a further embodiment, the invention provides methods for performing a biopsy on target tissue at a desired site within a patient, and of p
Burbank Fred
Jones Michael L.
Lubock Paul
Quick Richard L.
Shabaz Martin V.
Coudert Brothers LLP
Hindenburg Max
SenoRx, Inc.
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