Abstract:
A biopsy marker introduction assembly is configured for introduction through a specimen retrieval recess into a probe cutter lumen of a handheld breast biopsy handle. Advancing the cutter causes an extending deployment rod to distally translate within an introducer tube of the introduction assembly, pushing a biopsy marker out of a distal end of the probe at a surgical biopsy site. Thereby, the surgeon is able to position the probe and effect deployment of the marker even if using the other hand to position an imaging device such as an ultrasonic transceiver.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates, in general, to an applier for delivering and deploying a marker for implantation in tissue of a surgical patient, and more particularly, to such an applier for delivering and deploying an implantable biopsy marker for defining specific locations in human tissue during a biopsy procedure, especially in a human breast.  
       BACKGROUND OF THE INVENTION  
       [0002]     One in nine American women will develop breast cancer in their lifetime. It is the leading cause of cancer deaths in women 40-55 years of age and the second leading cause of cancer deaths in women overall. Breast cancer will be diagnosed in approximately one in eight women in their lifetime, and one in 30 will die of this disease. Breast cancer does occur in males, but is much less common. Biopsy requests stem from a screening process generally performed via a physical examination (palpable) and/or mammogram (non-palpable). A biopsy is indicated if suspicious tissue is detected. Five out of six biopsies performed return benign indications.  
         [0003]     It is desirable and often necessary to perform procedures for detecting, sampling, and testing lesions and other abnormalities in the tissue of humans and other animals, particularly in the diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions and other diseases or disorders. Typically, in the case of cancer, when a physician establishes by means of known procedures (i.e. palpation, x-ray, magnetic resonance imaging (MRI), or ultrasound imaging) that suspicious circumstances exist, a biopsy is performed to determine whether the cells are cancerous. Biopsy may be an open or percutaneous technique. Open biopsy removes the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). Percutaneous biopsy on the other hand is usually done with a needle-like instrument and may be either a fine needle aspiration (FNA) or a core biopsy. In the FNA biopsy, very small needles are used to obtain individual cells or clusters of cells for cytologic examination. The cells may be prepared such as in a Papanicolaou (Pap) smear. In core biopsy, as the term suggests, a core or fragment of tissue is obtained for histologic examination, which may be done via a frozen section or paraffin section. The chief difference between FNA and core biopsy is the size of the tissue sample taken. An imaging system having spectroscopic capabilities, such as the stereotactic guidance system, is employed to guide the extraction instrument to the lesion.  
         [0004]     A significant advance in core biopsies in a diagnostic imaging modality such as X-ray, MRI, ultrasonic, etc. have been facilitated by a hand-held biopsy device, such as described in U.S. Pat. No. 6,086,544, the disclosure of which is hereby incorporated by reference in its entirety. Being handheld, this generally known “MAMMOTOME” breast biopsy system creates a less intimidating and more-comfortable arrangement for the patient with minimal procedure preparation time as compared to a tabletop fixed biopsy device. The procedure may be completed in less than an hour in a doctor&#39;s office or on an outpatient basis under a local anesthetic and requires no surgery or stitches. It allows the patient to lie comfortably on her back.  
         [0005]     A probe need only be inserted once into the patient&#39;s breast via a small incision. Once inserted and positioned via imaging (e.g., ultrasonic, MRI), the needlelike probe can collect multiple samples by means of vacuum aspiration and an internal rotating cutter. The vacuum draws the sample into the probe aperture within reach of the cutter. From there, tissue samples can be obtained in and around the targeted area. Even though the incision is smaller, these samples can be eight times the weight of samples obtained with traditional spring-loaded biopsy equipment.  
         [0006]     It should be appreciated that a generally known vacuum assisted breast biopsy system described above has incorporated an onboard microprocessor to automate the sampling process. A positioning sensor allows the color touch-screen monitor to reflect the exact position of the cutting tip. An easy-to-follow graphical user interface gives surgeons maximum control over the location from which the biopsy sample is taken. A two-motor cutting drive system self-contained in the base unit and connected to a lightweight handpiece eliminates the need to table-mount the cutter assembly. Lightweight, flexible cables connect the base to the disposable handpiece. This handheld unit, which incorporates cutter position sensors, allows physicians to place the sampling probe accurately and obtain larger samples of suspect tissue.  
         [0007]     The cutting drive system includes direct feedback control of both cutter translational and rotational speeds. When either the translational speed or rotational speed is not at the desired rate due to increased or decreased loading on the system, the control feature modifies the power to the motor. This allows the speeds to remain near their desired levels, enabling maximum control throughout the procedure. The cutter can sample both palpable and nonpalpable lesions, including spiculated masses, asymmetric densities, multifocal disease, and diffuse tissue.  
         [0008]     In addition, the handheld cutting probe includes ergonomic features to allow for easy manipulation and procedure control such as a soft-touch finger-control keypad. Precise position control lets the cutter close the aperture through which the sample enters without bottoming out at the end of the probe. Good position control (e.g., within 0.001 in.) enables the minimization of the length of the cushion, or “dead zone,” at the end of the probe. Incision of the tissue and completion of the sampling as directed is achieved without causing damage to healthy surrounding tissue.  
         [0009]     This hand-held biopsy device is capable of rapidly taking a number of biopsy samples, assisted by a vacuum capability that draws tissue into proximity with a cutter. A computer-controlled vacuum system enables the vacuum to cycle on and off, and optimizes the vacuum in accord with the cutter activity. The vacuum retrieval system allows the caregiver to take multiple samples of a lesion while the needle probe remains in the breast. Moreover, large enough samples are obtainable, avoiding dry taps, or the inability to obtain an adequately sized sample of the suspect tissue, a common problem associated with other breast biopsy systems. Moreover, the hand-held biopsy device may further completely remove suspicious material as a therapeutic treatment for suspicious lesions.  
         [0010]     With this ability to completely remove a lesion, however, comes a desire to mark this location for later reference, such as for further treatments or later diagnostic follow-up. To that end, an applier for an implantable surgical marker is advantageously used in conjunction with a hand-held biopsy device, such as described in U.S. Pat. No. 6,261,302, the disclosure of which is hereby incorporated by reference in its entirety. After a last specimen is retrieved from a probe of the hand-held biopsy device, the cutter is withdrawn so that an open lumen is presented between a specimen collection bowl and a distal aperture of the probe. A flexible introducer of the marker applier is inserted through the lumen and then the marker is released at the desired location by depressing a button on the marker applier.  
         [0011]     While this technique accomplishes the desired end, it would be desirable to simplify the procedure. For instance, when using ultrasonic imaging to position the probe of the biopsy device, the surgeon typically has to hold an ultrasonic transceiver with one hand. The other hand directs the biopsy device to the desired location and controls the taking of samples. Then a third hand is needed to actuate the marker applier. It would be desirable that a two-hand procedure would be adequate while maintaining the efficiency and convenience of using a handheld biopsy system.  
         [0012]     In addition, it would be desirable to have the same degree of control and repeatability in marker placement that is available in taking the tissue samples themselves. Generally-known marker placement devices, such as the MICROMARK II device described above, relies upon the user to insert its distal end fully through the open needle of the biopsy device. Actuating the marker placement device in some instances may fail to deploy the marker from the biopsy probe, however.  
         [0013]     Consequently, a significant need exists for an improved approach to placing a biopsy marker with the aid of a biopsy instrument.  
       BRIEF SUMMARY OF THE INVENTION  
       [0014]     The invention overcomes the above-noted and other deficiencies of the prior art by providing a marker introducing assembly that advantageously conforms to a biopsy probe and is actuated by a cutter of a biopsy handle to deploy a biopsy marker out of a distal end of the biopsy probe. Thereby, a surgeon may advantageously position the biopsy probe to a desired surgical site and actuate a cutter control to deploy the marker while having another hand free to perform other functions such as positioning an ultrasonic transceiver for imaging the biopsy probe.  
         [0015]     In one aspect of the invention, a biopsy introducing assembly includes an alignment feature that confirms a fully seated and oriented placement into the biopsy probe so that advancement of the cutter of the biopsy handle will achieve full travel without bottoming out to reliably deploy the marker.  
         [0016]     In another aspect of the invention, a biopsy system and method alters a direct feedback control of the cutter of the biopsy handle to a desired translation distance appropriate for the marker introducing assembly to reliably deploy the marker without bottoming out a plunger therein that communicates between the marker and the cutter. In addition to translation distance control, rate of translation and disabling cutter revolution may be included. Thereby, the surgeon is able to use biopsy controls in a familiar manner for deploying the marker as is used in taking the biopsy samples.  
         [0017]     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0018]     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.  
         [0019]      FIG. 1  is a left side elevation view with a left half cut-away of a biopsy system with a cutter of a biopsy handle retracted allowing placement of a biopsy marker introduction assembly into a biopsy probe.  
         [0020]      FIG. 2  is a left side elevation view in cross section of the biopsy marker introduction assembly of  FIG. 1 .  
         [0021]      FIG. 3  is a left side elevation view in cross section of the biopsy marker introduction assembly seated in the biopsy probe of  FIG. 1 .  
         [0022]      FIG. 4  is a left side elevation view in cross section with the cutter advanced to drive a plunger through an introducer tube to deploy the marker out of the biopsy probe of the biopsy handle of  FIG. 1 .  
         [0023]      FIG. 5  is a perspective view of a handheld breast biopsy device in phantom with a flexible marker introduction assembly being inserted.  
         [0024]      FIG. 6  is a perspective view of the handheld breast biopsy device of  FIG. 5  with the flexible marker introduction assembly further inserted.  
         [0025]      FIG. 7  is a right-side elevation view of the handheld breast biopsy device taken in longitudinal cross section along lines  7 - 7  of  FIG. 6 .  
         [0026]      FIGS. 8-11  are right side elevation views of a cutter of the handheld breast biopsy device and the marker introduction assembly taken in longitudinal cross section along lines  7 - 7  of  FIG. 6  depicting a sequence respectively of the cutter engaging the pusher, the cutter advanced to expose a marker in a specimen opening of the probe, the cutter advanced to ramp a distal end of the marker against an angled surface of the assembly, and the cutter advanced to fully deploy the marker by underrunning a driver tip of the pusher.  
         [0027]      FIG. 12  is a sequence of operations or procedures for controlling a biopsy system to deploy a biopsy marker at a surgical biopsy site. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0028]     Turning to the Drawings, wherein like numerals refer to like components throughout the several views, in  FIG. 1 , a breast biopsy handle  10  of a biopsy system  12 , a minimally invasive device, is used under local anesthetic and ultrasound guidance to collect multiple biopsy samples with a single insertion of a probe  14  into the breast of a patient. After which, a cutter  16  is retracted proximally in a housing  18  of the biopsy handle  10  to expose a distally opening entry cone  20  of a cutter lumen  22  of the probe  12 . The surgeon may then insert and seat a biopsy marker introduction assembly  24 , which is shown separately in  FIG. 2 .  
         [0029]     Also shown in  FIG. 2  is a Mylar sealing cap  26  that has been removed just prior to use from a distal end  28  of the introduction assembly  24  to expose a laterally disposed deployment opening  30  in an introducer tube  32 . A marker  34  is positioned inside of the introducer tube  32  proximal to the deployment opening  30  that has sufficient length to allow the marker  34  to be laterally expelled when a distal end  36  of the marker  34  ramps against an angled surface  38  at the distal end  28  of the introduction assembly  24 . Thus, a proximal end  40  of the marker  34  resides approximately twice the length (2×) of the marker  34  from the angled surface  38  when in its initial state as depicted. Abutting this proximal end  40  is a marker pusher, depicted as a plunger tip  42  of a marker deployment rod  44  that longitudinally translates within the introducer tube  32 . The plunger tip  42  in some applications dynamically seals to the interior of the introducer tube  32  to form a sterile environment for the marker  34  and to pneumatically assist in deploying the marker  34 . For instance, the plunger tip  42  may push air toward the marker  40  as a syringe, which may advantageously reduce the amount of travel required for the cutter  16 . Alternatively or in assistance thereof, a vacuum lumen  45  in the probe  14  may provide vacuum assist to draw the plunger tip  42  and bleed any excess pressure from the surgical site.  
         [0030]     A proximal end  46  of the marker deployment rod  44  terminates in a cutter seat  48  that extends proximally beyond the entry cone  20  of the cutter lumen  22  a sufficient distance to provide full travel of the marker deployment rod  44  yet fit within a specimen retrieval recess  50  formed within the housing  18  of the biopsy handle  10 . The cutter seat  48  has a greater lateral diameter than the tube-shaped cutter  16  to ensure contact. Since the cutter  16  closely fits the inner diameter of the cutter lumen  22 , the cutter seat  48  reaches full travel at the entry cone  20 .  
         [0031]     With reference to  FIGS. 2-3 , a funnel  50  flared proximally and attached to a proximal end  52  of the introducer tube  32  encompasses the cutter seat  48  and the portion of the marker deployment rod  44  that extends proximal to the entry cone  20 . The funnel  50  advantageously includes an alignment feature, such as a transversely extending key  54 , that mates with a corresponding alignment feature in the biopsy probe  14 , such as a proximally opened recess  56 . These alignment features  54 ,  56  ensure that the marker introduction assembly  30  is correctly rotated to present its deployment opening  30  to a specimen opening  58  of the probe  14 . In addition, visual and tactile confirmation is given that the introduction assembly  24  is fully inserted into the probe  14  so that reliable deployment of the marker  34  may be achieved.  
         [0032]     In  FIG. 4 , the cutter  16  has been advanced, distally translating the deployment rod  44  to deploy the marker  34 . Then the probe  14  may be withdrawn leaving the marker  34  behind. In some applications, the existing controls of the biopsy system  12  may be used to achieve deployment as depicted in  FIG. 4 . Thus, the cutter seat  48  may advantageously resist damage from a cutter  16  that is rotating (e.g., hardened surface, low friction surface, or configured to be rotated by the cutter). The surgeon would command forward translation of the cutter until visually confirming full travel or the cutter is prevented from further travel by the cutter seat  48  engaging introducer tube  32 .  
         [0033]     In  FIGS. 1-4 , the breast biopsy handle  10  depicted is similar to sterotactic devices attached to a tabletop. A handheld MRI-compatible biopsy device  60  is depicted in phantom in  FIGS. 5-6  for use with a marker introduction assembly  62 . In some applications, access to an entry cone  64  of a cutter lumen  66  of a probe  68  may be constrained by the shape of a specimen retrieval recess  70  formed in a handle  72  of the handheld breast biopsy device  60 . Consequently, portions of the marker introduction assembly  62  are formed of a sufficiently flexible material, as depicted in  FIG. 5 , to be bent during insertion into the biopsy handle  70 . In  FIGS. 5-6 , an alignment key  74  along the top of a funnel  76  rotationally and longitudinally orients an attached introducer tube  78  within the cutter lumen  66  of the probe  68 . The introducer tube  78  is sufficiently thin to allow advancement of a cutter  80  (depicted in  FIGS. 8-11 ) as desired within the cutter lumen  66  without binding. This has an added advantage of thus being usable in specimen retrieval recesses  70  that are not at least twice the length of a marker  82  or when it is otherwise desirable to advance the cutter  80  more fully during deployment of the marker  82 .  
         [0034]     In  FIG. 7 , the marker introducing assembly  62  has been inserted into the probe  68  in preparation for the surgeon initiating deployment of the marker  82 . In  FIG. 8 , the cutter  80  has been advanced into contact with a cutter seat  84 . In  FIG. 9 , the cutter  80  has further distally advanced, driving a pusher rod  86  and its driving tip  88 , and thus the distally placed marker  82  to expose the marker in a distal opening  90  of the introducer tube  78 . In  FIG. 10 , the cutter  80  has been further advanced so that the distal end of the marker  82  ramps outward against an angled surface  92  of the distal opening  90 . In  FIG. 11 , the cutter  80  has further advanced so that the driving tip  88  has underrun the fully deployed marker  82  and has been received within a tip slot  94  of the introducer tube  78  (shown also in  FIG. 6 ).  
         [0035]     The pusher rod  86  advantageously closes the distal opening  90  of the introduction assembly  62  and thus a specimen opening  96  of the probe  68 . This may be an advantageous feature that allows retracting the probe  68  without inadvertently dragging out the marker  82 . Thus, there is no requirement to rotate the probe  68  as an additional step or alternatively to remove the introduction assembly  62  and replace it with a stylus (not shown) to close the probe  68 .  
         [0036]     It is desirable to include a marker deployment mode into the controls of the biopsy system  12  to optimize this function. For instance, if two motors are used, one for longitudinal translation of the cutter and one for rotating the cutter  16 , then dedicated control logic would allow disabling cutter rotation during deployment. Also, the amount of longitudinal travel and the rate of travel may be optimized for marker deployment. In  FIG. 5 , an illustrative sequence of operations or procedure  100  for biopsy device control of marker deployment is depicted as a flow diagram.  
         [0037]     A surgical cite within the patient&#39;s breast is imaged (e.g., ultrasonic imaging) (block  102 ) to guide the surgeon to insert and position the probe (block  104 ). Vacuum is applied through the probe to assist in drawing tissue into a specimen bowl of the probe (block  106 ) while the cutter is rotated and distally translated to cut the tissue. The probe may be repositioned, such as by rotating the probe to present the specimen bowl at a different angle with the specimen bowl blocked by the extended cutter. Thereafter, the cutter and sample are proximally retracted (block  110 ). These actions of blocks  104 - 108  may be repeated to the surgical site between biopsies or by otherwise repositioning the probe.  
         [0038]     Once the biopsies at the surgical site are complete, then the surgeon engages the marker introduction assembly (“introducer”) into the biopsy probe (block  112 ) and enables deployment mode of the marker (block  114 ). The interface between the introducer and the biopsy handle may be such that its presence is sensed by a sensor (block  116 ) and automatically prepares the biopsy system for deployment mode, preventing inadvertent rotation of the cutter or an inappropriate application of the vacuum assist system and/or adjusting cutter travel and/or rate of travel. Enabling deployment mode may be manual (block  118 ) wherein the surgeon uses a control, such as pushing a deployment soft button, to initiate deployment mode. As a further example, a remote control unit that is spaced away from the biopsy handle may initiate deployment mode (block  120 ). For example, a control unit may be elsewhere in the surgical suite, for instance in an MRI or CTI facility wherein the biopsy system is remotely actuated.  
         [0039]     If marker deployment mode has been enabled, then cutter rotation may advantageously be disabled in a two-motor biopsy system (block  122 ). Distal translation speed is set (block  124 ). For instance, a greater rate of travel may be desired to better propel the marker from the probe. Maximum cutter travel may be set (block  126 ) to avoid binding and damage, especially if the mechanical advantage of the motor and mechanization is such as to cause damage before full travel may be sensed. It may be desirable to use a fluid drainage capability of the biopsy system at this point, such as using the vacuum assist system to remove fluid from the surgical site and/or to insufflate the surgical site to provide a cavity to receive the biopsy marker (block  128 ).  
         [0040]     Then the cutter is advanced to deploy the marker (block  130 ), which may be a programmed mode that is initiated by the surgeon (block  132 ) or a manual process (block  134 ) with a deployment command maintained by the surgeon. Imaging may be performed contemporaneously or subsequently to confirm that the marker has been deployed at the surgical site (block  136 ). Advancement continues until a determination is made that the marker is deployed (block  138 ), which may be determined based on one or more conditions such as the biopsy system sensing full travel, sensing of cutter binding at full travel, visual confirmation of the marker deployment, etc.  
         [0041]     In some applications, the introducer and/or biopsy probe may be determined to be insufficiently closed at this point (block  140 ), such as the introducer prevents closure. To prevent inadvertently dislodging the marker, the cutter is retracted (block  142 ), the marker introducer is removed with the probe still in place (block  144 ), the probe is rotated (e.g., 180 degrees) so that the specimen bowl is moved away from the marker to prevent its inadvertent entry (block  146 ), and the cutter is advanced to close the port (block  148 ). Once the port is determined to be closed in blocks  140  or  148 , then the probe is removed (block  150 ).  
         [0042]     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.  
         [0043]     For example, It should be appreciated that the illustrative embodiment describes a handheld biopsy procedure guided by ultrasonic imaging to accentuate advantages of incorporating marker placement into biopsy instrument controls. However, aspects of the present invention pertain to tabletop fixed biopsy instruments, biopsy instruments used for tissue other than the breast, biopsy instruments positioned with other imaging modalities such as X-ray and Magnetic Resonance Imaging (MRI), and remotely actuated biopsy instruments.  
         [0044]     For example, although a vacuum-assisted biopsy system has been advantageously depicted herein as benefiting from a marker introduction device, it should be appreciated that application of a marker introduction device to a core needle biopsy device would provide similar advantages, allowing a surgeon to place a marker while positioning the core needle device with reference to a diagnostic image.  
         [0045]     For another example, although a specific handheld biopsy device is described, it should be appreciated that a detachable probe may be used in conjunction with a marker introduction device.  
         [0046]     As yet another example, although affirmatively driving the marker with the cutter of a biopsy handle has a number of advantages, it should be appreciated that the vacuum assist control system of a biopsy system consistent with aspects of the invention may be used to draw a plunger of a biopsy marker introduction device toward the distal end of the probe. With the plunger fully translated distally, the marker would deploy and then the vacuum assist may be removed, leaving the marker in place as the biopsy probe is removed.