MRI Biopsy Apparatus Incorporating a Sleeve and Multi-Function Obturator

Abstract

A localization mechanism, or fixture, is used in conjunction with a breast coil for breast compression and for guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines. The localization fixture includes a three-dimensional Cartesian positionable guide for supporting and orienting an MRI-compatible biopsy instrument, and in particular a sleeve, to a biopsy site of suspicious tissues or lesions. A depth stop enhances accurate insertion, and prevents over-insertion or inadvertent retraction of the sleeve. The sleeve receives a probe of the MRI-compatible biopsy instrument and may contain various features to enhance its imageability, to enhance vacuum and pressure assist therethrough, and marker deployment etc.

1 - 48 . (canceled) 
     
     
         49 . A medical system, comprising:
 an introducer having an introducer cannula generally defined by an axis, a latch portion, a valve, and a hub, wherein the cannula is defined, at least in part, by an inner lumen, the latch portion is adapted to releasably secure the introducer to a medical device, the hub includes a proximal end and a distal end, the introducer cannula includes an introducer cannula distal end, and the valve is selectively interposed within the introducer so as to seal between the introducer cannula and a medical device portion interposed within the introducer cannula.   
     
     
         50 . The system of  claim 49 , wherein the valve has a first flap and a second flap biased toward a closed position, the first flap having a first flap opening surface, the second flap having a second flap opening surface, and wherein the first flap opening surface is selectively in contact with the second flap opening surface to seal an inner lumen of the introducer cannula. 
     
     
         51 . The system of  claim 50 , wherein the first flap opening surface and the second flap opening surface are formed integrally with the valve. 
     
     
         52 . The system of  claim 50 , wherein a portion of the first flap adjacent the first flap opening surface is positioned at an angle relative to a portion of the second flap adjacent the second flap opening surface when the first flap opening surface is in contact with the second flap opening surface. 
     
     
         53 . The system of  claim 50 , wherein the valve is formed of a single body having an outer periphery and a slit formed therein, the slit does not intersect the outer periphery, and wherein the slit defines the first flap opening surface and the second flap opening surface. 
     
     
         54 . The system of  claim 49 , wherein the system is constructed of a material that is magnetic resonance imaging (MRI) compatible. 
     
     
         55 . A medical system comprising:
 a first medical device having an elongated cannula and an introducer engaging end;   an introducer having an introducer cannula and a hub having a hub proximal end and a hub distal end, wherein the introducer is defined, at least in part, by an introducer distal end and an introducer proximal end, and wherein the introducer proximal end is engaged with the medical device; and   a latch extending from one of the introducer and the first medical device, wherein the latch will selectively engage the first medical device with the introducer so as to axially restrain at least a portion of the medical device relative to the introducer cannula during at least a portion of a medical procedure.   
     
     
         56 . The system of  claim 55 , wherein the latch will engage the first medical device with the introducer as the first medical device cannula is interposed within the introducer cannula, and wherein the latch may be manipulated so as to disengage the first medical device from the introducer so as to permit the first medical device cannula to be withdrawn from the introducer cannula. 
     
     
         57 . The system of  claim 55 , wherein the elongated cannula will selectively permit a medical treatment to be delivered through the introducer cannula. 
     
     
         58 . The system of  claim 55 , wherein the elongated cannula will selectively capture a biopsy sample for removal through the introducer cannula. 
     
     
         59 . The system of  claim 55 , further comprising a valve at least partially interposed within the introducer. 
     
     
         60 . The system of  claim 59 , wherein the valve is interposed within the introducer, the valve has a first flap and a second flap, the first flap having a first flap opening surface, the second flap having a second flap opening surface, wherein the first flap opening surface is selectively in contact with the second flap opening surface to seal the inner lumen, and wherein the first flap opening surface and the second flap opening surface are selectively in contact with the elongated cannula to seal the inner lumen when the elongated cannula is interposed within the introducer cannula. 
     
     
         61 . A method of performing a medical procedure, comprising:
 inserting an introducer cannula into a patient's body in a pathway to a target tissue;   inserting a portion of a first medical device cannula into the introducer cannula;   removing a biopsy portion from the patient's body;   inserting a portion of a second medical device cannula into the introducer cannula;   unlatching the introducer cannula from one of the first medical device and the second medical device.   
     
     
         62 . The method of  claim 61 , further comprising latching the first medical device to the introducer cannula with a latch such that axial movement is restricted between at least a portion of the first medical device and at least a portion of the introducer cannula, wherein the latch includes a release portion and manipulation of the release portion will permit unlatching of the introducer cannula from the first medical device. 
     
     
         63 . The method of  claim 61 , further comprising providing a valve and interposing the medical device within the valve to form a seal between the outer cannula and a portion of the medical device. 
     
     
         64 . The method of  claim 63 , further comprising deploying the site marker within a biopsy site. 
     
     
         65 . A slotted introducer device, comprising:
 a cannula selectively insertable into a patient's tissue, the cannula having an open distal end and an open proximal end;   wherein the cannula defines an inner lumen therein, the inner lumen extending from the open proximal end to the open distal end; and wherein the cannula defines at least one aperture in a side wall thereof, the aperture allowing fluid communication between the inner lumen and the area outside the cannula.   
     
     
         66 . The slotted introducer device of  claim 65 , wherein the cannula is configured to receive a medical device therein. 
     
     
         67 . The slotted introducer device of  claim 66 , wherein the medical device is one of a stylet, a biopsy device and a target confirmation device. 
     
     
         68 . A method of obtaining a biopsy sample, the method comprising:
 (a) inserting a hollow cannula into a patient's breast, wherein the hollow cannula defines a cannula lumen, a distal opening, and a proximal opening, wherein the hollow cannula has a seal configured to seal the proximal opening relative to the distal opening, wherein an obturator is positioned in the cannula lumen during the act of inserting the hollow cannula into the patient's breast, wherein the seal is configured to seal against the obturator;   (b) taking an MRI image of the patient's breast with the hollow cannula inserted in the patient's breast;   (c) removing the obturator from the hollow cannula, wherein the hollow cannula remains inserted in the patient's breast during the act of removing the obturator from the hollow cannula, wherein the seal is configured to seal the proximal opening relative to the distal opening with the obturator removed from the hollow cannula;   (d) inserting a needle of a biopsy device through the proximal opening and into the cannula lumen to introduce the needle into the patient's breast, wherein the seal is configured to seal against the inserted needle; and   (e) operating the biopsy device to obtain a tissue sample from the patient's breast through the distal opening of the hollow cannula via the inserted needle.