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  Self-contained, self-piercing, side-expelling marking apparatusUSPTO Application #: 20060036158Title: Self-contained, self-piercing, side-expelling marking apparatus Abstract: A self-contained, self-piercing, and side-expelling marking apparatus for percutaneously placing a imaging marker in a tissue mass. (end of abstract)
Agent: Mcgarry Bair PC - Grand Rapids, MI, US Inventors: Steven E. Field, Ryan L. Goosen, Brian R. Mulder USPTO Applicaton #: 20060036158 - Class: 600414000 (USPTO) Related Patent Categories: Surgery, Diagnostic Testing, Detecting Nuclear, Electromagnetic, Or Ultrasonic Radiation, Magnetic Resonance Imaging Or Spectroscopy, Using Fiducial Marker The Patent Description & Claims data below is from USPTO Patent Application 20060036158. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This invention relates generally to an apparatus for the percutaneous positioning of an imaging marker for identifying the location of a lesion in a biopsy procedure. More particularly, the invention relates to a self-contained marking apparatus that expels the imaging marker through the side of the marking device. DESCRIPTION OF THE RELATED ART [0002] Tissue biopsies are commonly performed on many areas and organs of the body where it is desirable to ascertain whether or not the biopsied tissue is cancerous. Often, a lesion or other tissue to be biopsied is identified through use of an imaging technique such as a computerized axial tomography (CAT) scan, ultrasonography, magnetic resonance imaging, and mammography. [0003] One problem commonly encountered, especially in breast biopsies, is that the lesion is so small that the biopsy reduces its size to the extent that it is no longer visible by the imaging method employed. In such circumstances, it is desirable to place an imaging marker at the site of the biopsy to enable the medical practitioner subsequently to locate the lesion quickly and accurately in the event complete removal of the affected tissue is indicated. This problem is currently met by placing an imaging marker at the biopsy area by means of a cannula or similar device housing the marker. [0004] There are currently two primary types of marking devices. One of the primary types is referred to as vacuum assisted biopsy devices (VAB's). The VAB devices are many times integrated with a mammography imaging system. They include a large diameter cannula, approximately 9 to 12 gage, or probe that is inserted into the breast tissue. Instruments, such as a biopsy device and a marking device, are introduced into the breast tissue through the large diameter cannula to take biopsy samples or mark a biopsy location. [0005] The other primary type is self-contained marking devices comprising a small diameter, approximately 14 to 17 gage, open-end cannula and a stylet slidably received within the cannula. A marker is located in the cannula and expelled out the open-end upon the advancing of the stylet relative to the cannula. [0006] One disadvantage of the VAB system is the biopsy and marking tools are integrated with the mammography imaging system. The capital investment of this type of system is substantial. Also, the biopsy and marking tools are typically designed to work only with the large diameter probe, which tends to lock the hospital or medical professional into the same source for the imaging system and the biopsy and marking tools. The VAB systems are also intended for the same components to be reused, which requires sterilization after each step. The various components are also typically flexible to help insert them through the probe. The VAB systems also have a relatively large diameter probe, which, all things being equal, the larger the diameter, the greater trauma to the surrounding tissue and the greater the pain or discomfort for the patient. [0007] The self-contained marking devices address these disadvantages of the VAB systems. Since the self-contained marking device is not integrally incorporated with a particular imaging system, the self-contained marking devices can be used with any suitable imaging system and are not limited to just mammography. This permits the hospital or medical professional to mix and match the available imaging systems and self-contained marking devices to obtain the desired performance and cost-effectiveness. [0008] The self-contained marking devices are typically disposable, which negates the need to sterilize them after each use. They also have a much smaller diameter, resulting in much less trauma to the surrounding tissue and pain to the patient. [0009] A disadvantage of the self-contained systems is that the cannula has an open tip through which the marker is expelled. The open tip is generally closed by the marker residing in the cannula. However, the marker does not completely close off the open tip and it is possible for tissue to enter the open end of the cannula during the positioning of the marking device. The presence of tissue inside the open end of the cannula can interfere or make more difficult the expelling of the marker from the cannula. [0010] The possibility for tissue being present in the open end of the cannula is, to some extent, related to the distance that the cannula is inserted through the tissue to the marking site. Thus, the manner in which the marking device is located at the biopsy site can impact the presence of tissue in the open end of the cannula. For example, the self-contained systems are sometimes used in combination with a positioning cannula that is inserted into the tissue mass with a stylet closing the end of the positioning cannula. In such a configuration, the stylet is removed once the positioning cannula is properly located relative to the biopsy site. Both the biopsy device and the marking device can be inserted and withdrawn through the positioning cannula. The use of the positioning cannula reduces the distance that the open end of the marking device cannula must travel through the tissue. [0011] Alternatively, the marking device can be inserted without the positioning cannula. This is most common when it is desirable to place a marker without taking a biopsy. Under such circumstances, it is more likely that tissue will be received within the open end of the cannula. Therefore, it is more likely that the tissue will interfere with the expelling of the marker. [0012] Therefore, it is desirable to have a self-contained marking device that can be used with or without a positioning cannula and which does not receive tissue within the open end of the cannula that might interfere with the expelling of the marker. SUMMARY OF THE INVENTION [0013] The invention relates to a marking apparatus for the percutaneous placement of an imaging marker at a predetermined location in a tissue mass to facilitate subsequent determination of the predetermined location. The marking apparatus comprises a handle, cannula, and plunger. The handle is to be grasped by a user to aid in the placement of the marker. [0014] The cannula comprises a peripheral wall forming a lumen, with a proximal end carried by the handle, and a distal end terminating in a self-piercing tip. A lateral opening is formed in the peripheral wall and is open to the lumen. [0015] A plunger having a distal end is slidably received within the lumen for movement between a ready position, where the distal end is spaced inwardly from the self-piercing tip to form a marker recess in communication with the lateral opening and sized to receive an imaging marker, and an expelled position, where the distal end is advanced a sufficient distance into the marker recess to expel a marker contained therein through the lateral opening. [0016] One or more imaging markers can be positioned within the marker recess. [0017] The handle, cannula, plunger are operably coupled such that they form a self-contained marking apparatus that can be easily and conveniently handled by a user to effect operation of the marking apparatus from the ready position to an expelled position. [0018] The cannula is preferably sufficiently rigid and a distal end of the cannula is pointed to form the self-piercing tip. The cannula is 13 gage or less. [0019] A ramp can be provided on at least one of the plunger and cannula to aid in expelling an imaging marker. The ramp can be located in the lumen adjacent the lateral opening. The distal end of the plunger can be flexible to be deflected toward the lateral opening by the ramp when the plunger is moved to the expelled position. The ramp can also be located on the distal end of the plunger. [0020] The invention also relates to a method for percutaneously placing a marker at a predetermined location in a tissue mass using a self-piercing, side-ejecting, self-contained marking apparatus comprising a cannula defining a lumen and terminating in a self-piercing tip, with a lateral opening in communication with the lumen, and a plunger slidably received within the lumen for expelling a marker in the lumen through the lateral opening. The method comprises: inserting the cannula into the tissue mass by puncturing an exterior of the tissue mass with the self-piercing tip, and expelling the marker through the lateral opening by sliding the plunger within the lumen. [0021] The inserting step can comprise locating the lateral opening near a predetermined location in the tissue mass where it is desired to be marked. Preferably, the lateral opening is located beneath the predetermined location. Continue reading... Full patent description for Self-contained, self-piercing, side-expelling marking apparatus Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Self-contained, self-piercing, side-expelling marking apparatus patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. 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