Patent Document

BACKGROUND OF THE INVENTION 
       [0001]    1. Field of Invention 
         [0002]    Aspects of the present invention relate to methods and devices for performing vacuum assisted biopsies. More particularly, aspects of the current invention relate to methods and devices for performing vacuum assisted spring-loaded biopsies. 
         [0003]    2. Description of Related Art 
         [0004]    A variety of biopsy devices having sampling needles as part of their structure are available in the medical field. Typical biopsy devices include those that are designed to obtain samples from hard tissues, such as bone, and those that are designed for sampling of softer tissues. Soft tissue biopsy devices can include a structure whereby a sampling needle resides within an outer cannula and moves relative thereto during sampling. In particular, the operation of the device involves extending the distal end of the sampling needle beyond the distal end of the outer cannula to expose and introduce a portion of the needle to the tissue sampling site. 
         [0005]    For example, U.S. Pat. No. 7,018,343 describes a spring-loaded biopsy device, described herein with respect to  FIGS. 1A-1B . The biopsy device  20  is illustrated in  FIG. 1A , the biopsy device  20  having a rapid firing mechanism within (not shown), which can include typical components that can be found in such devices, such as a handle portion  21  housing the operative mechanism components (not shown), loading and trigger component  22 , outer cannula  23  and biopsy needle  2  partially residing within the outer cannula  23  with the distal end portion of the needle  2  exposed. Such biopsy devices can contain parts, e.g., the handle portion and loading and trigger component, composed of conventional materials, such as plastic or metallic materials. A profile of the needle  2  extending from the cannula  23  is illustrated in  FIG. 1B , where the needle  2  includes a notch configured to collect tissue samples. 
         [0006]    However, the samples obtained by the above devices generally do not fill the entire space enclosed in the notch within the biopsy device, and the collected samples are not as large as they could possibly be, which could sometimes lead to inaccurate diagnoses obtained from the sample. 
         [0007]    There is a need in the art, therefore, for biopsy devices capable of obtaining samples that fill the entire space enclosed in the notch and that ensure the collected samples are as large and contiguous as possible. 
       SUMMARY OF THE INVENTION 
       [0008]    In light of the above described problems and unmet needs, aspects of the current invention provide biopsy systems and devices with a modified handle and stylet through which a vacuum is delivered to the targeted tissue prior to being severed by a cannula for removal. The biopsy needle, which is capable of penetrating skin and/or tissue to collect biopsy samples, may include a pointed stylet. A distal portion of the stylet may include a notch capable of receiving tissue that has been severed by the cutting cannula. According to various aspects, the vacuum may draw the sample into the notch to fill a larger amount of the notch, after which the tissue may be severed via the cannula. Alternatively, the tissue that is severed via the stylet and the cannula may be deposited within the notch, and the vacuum may be used to maintain the severed tissue within the notch while the biopsy device is extracted from the body of the patient. For example, the vacuum may be used to draw a larger amount of tissue into the notch than would otherwise be collected in the notch if no vacuum was used before the tissue sample is severed by the biopsy device, thus providing a larger sample through the same size access point within the patient. 
         [0009]    According to various aspects, the vacuum also provides more assurance that the desired tissue is captured by clinician. Diseased tissue has varied densities when compared to non-diseased tissue, and the use of vacuum to pull the tissue of various densities into the notch provides clinical advantages compared to biopsy needles without vacuum. In addition, vacuum can be applied to needles of very small gauges, which results in improving the biopsy procedure with respect to smaller lesions or calcifications. 
         [0010]    There are many benefits of using a spring loaded cannula in combination with vacuum assistance. For example, the cannula provides a sharp cutting edge that cleanly severs the tissue within the notch in a fraction of second. The weight and size of the device are also clinical aspects of the proposed invention because the clinician needs to position the tip of the notch in exactly the right location, which is typically done under ultrasound, and once the tip is placed, the clinician needs to manipulate the stylet tip and vacuum in order to maximize the clinical benefit. The size and weight of the device generally hinder the ability of the clinician to position the biopsy device in the desired location. The visibility of the device under ultrasound is also a clinical factor. Markings on the tip of the stylet, including a small grove around the entire diameter of the stylet, may provide significant improvements of the visibility of the stylet tip from any direction with respect to the ultrasound probe. According to various aspects, surface texturing also improves the overall image. 
         [0011]    According to various aspects, the vacuum applied to the biopsy device may be controlled and provided in a variety of ways in order to ensure adequate suction of the tissue into the notch of the stylet of the biopsy device. The vacuum may be controlled by restricting flow through a valve mechanism where the clinician can control the total amount of vacuum being applied. Alternatively, the device may provide the clinician with the ability to turn on or off the vacuum at a predetermined level. According to various aspects, both options may provide varying clinical advantages depending on the type of tissue being biopsied, the size of the lesion or calcification, and the presence of potential clinical complications such as blood vessels, bone, membranes, etc. According to various aspects, the size of the vacuum pump, location of the trigger and amount of vacuum may also be clinically relevant. The pump can be small enough to fit within the clinician&#39;s hand or to stand alone on the table. Typical battery powered pumps may provide cost effective benefits to using vacuum as an assist for spring loaded biopsy devices. 
         [0012]    Additional advantages and novel features of these aspects of the invention will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    Various example aspects of the systems and methods will be described in detail, with reference to the following figures, wherein: 
           [0014]      FIGS. 1A-1B  illustrate a conventional spring-loaded biopsy device; 
           [0015]      FIGS. 2A-2B  are diagrams illustrating a vacuum-assisted biopsy device, according to various aspects of the current invention; 
           [0016]      FIGS. 3A-3D  are diagrams illustrating a cannula and notch in a vacuum-assisted biopsy device, according to various aspects of the current invention; 
           [0017]      FIGS. 4A-4D  are diagrams illustrating a communication between the cannula and the notch in a vacuum-assisted biopsy device, according to various aspects of the current invention; and 
           [0018]      FIGS. 5A-5B  are diagrams illustrating vacuum valves in a vacuum-assisted biopsy device, according to various aspects of the current invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0019]    These and other features and advantages of this invention are described in, or are apparent from, the following detailed description of various example aspects. 
         [0020]      FIGS. 2A-2B  are diagrams illustrating a vacuum-assisted biopsy device, according to various aspects of the current invention. In  FIG. 2A , the vacuum-assisted biopsy device  100  includes a stylet tip  110  that, during operation, penetrates the skin/tissue of a patient and is inserted through the skin to remove one or more tissue samples from the patient, the tissue samples being deposited in the notch  150  of the stylet tip  110 . According to various aspects, the stylet tip  110  may be connected to a vacuum pump  130  via a vacuum line  120  and a housing  160 , the vacuum pump  130  including a valve  140 . The housing  160  may include, in the case of a spring-loaded biopsy device, a valve mechanism and/or the firing mechanism to fire a cannula over the stylet tip  110  to sever tissue samples. According to various aspects, the housing  160  may also be used as a handle by an operator to operate the biopsy device. The valve  140  may, for example, only allow flow in a single direction such that air can only flow out of the vacuum pump  130  via the valve  140 , thus creating a vacuum. In addition, the valve  140  may help prevent foreign materials from coming in contact with the target tissue. 
         [0021]    In operation, the vacuum pump  130  may create a vacuum and transmit the vacuum via the vacuum line  120  to the stylet tip  110 . Accordingly, when the stylet tip  110  penetrates the skin/tissue of the patient, the vacuum provided through the vacuum line  120  may draw an amount of tissue in the notch  150  that is larger than if no vacuum was provided, and the tissue sample may then be severed via, for example, firing a cutting cannula. Alternatively, the tissue sample that is first severed via the stylet tip  110  may be deposited in the notch  150 , and the vacuum may be used to maintain the severed tissue sample within the notch  150  while the biopsy device is extracted from the body of the patient. As a result, when the stylet tip  110  is removed from the body of the patient, larger tissue samples can be collected by the biopsy device  100  because of the action of the vacuum that maintains a large amount of tissue inside the notch  150 . 
         [0022]    In  FIG. 2B , the vacuum-assisted biopsy device  200  includes a stylet tip  210  that is to be inserted within the body of a patient during a biopsy so that tissue sample(s) from the patient may be deposited in the notch  250  of the stylet tip  210 . According to various aspects, the stylet tip  210  may be connected to a vacuum pump  230  via a vacuum line  220 , the vacuum pump  230  including a valve  240 . The housing  260  may include, in the case of a spring-loaded biopsy device, a valve mechanism such valve assembly  270  and/or the firing mechanism to fire a cannula over the stylet tip  210  to sever tissue samples. According to various aspects, the housing  260  may also be used as a handle by an operator to operate the biopsy device. The valve  240  may, for example, only allow flow in a single direction such that air can only flow out of the vacuum pump  230  via the valve  240 . As such, the valve  240  may help prevent foreign materials from coming in contact with the target tissue. In operation, the vacuum pump  230  may create a vacuum and transmit the vacuum via the vacuum line  220  to the stylet tip  210 . Furthermore, an additional valve assembly  270  may be introduced between the stylet tip  210  and the vacuum pump  230  in order to regulate the vacuum flow between the stylet tip  210  and the pump  230 . According to various aspects, the valve assembly  270  may be in a closed state, where no vacuum is communicated to the stylet tip  210 , or in an open state, where a vacuum is communicated to the stylet tip  210 . 
         [0023]    In operation, the vacuum pump  230  may create a vacuum and may transmit the vacuum via the vacuum line  220  to the stylet tip  210  via the additional valve  270 . Accordingly, when the stylet tip  210  penetrates the skin of the patient, the vacuum provided through the vacuum line  220  may draw an amount of tissue in the notch  250  that is larger than if no vacuum was provided, and the tissue may then be severed via, for example, firing a cutting cannula. Accordingly, a larger amount of tissue sample may be collected in the notch  250  of the biopsy device  200  as compared to a biopsy performed without vacuum. 
         [0024]      FIGS. 3A-3D  are diagrams illustrating a cannula and stylet having a notch in a vacuum-assisted biopsy device, according to various aspects of the current invention. In  FIG. 3A , the biopsy device  300  includes the stylet tip  310  having the notch  350  connected to the vacuum line  320 . According to various aspects, the vacuum line  320  may include one or more outlets or passageways  315  that may allow for vacuum to flow between the vacuum line  320  and the environment during vacuum actuation by the vacuum pump. As such, when vacuum is applied and transmitted from the vacuum line, the tissue that has been severed, or that is about to be severed, by the cannula  340  may be attracted to the notch  350  via a vacuum travelling along the three arrows depicted in  FIG. 3A  and representative of the travel path of the suction action of the vacuum. As a result, a large amount of tissue may be attracted to the notch  350  which can be severed and extracted by the biopsy device  300 . 
         [0025]    According to various aspects, the circumference of the body of the stylet, which may correspond to a back portion of the stylet tip  310  and which is typically covered by the cannula  340 , may be altered such as to provide enough space for the vacuum to travel inside the cannula and around the outer surface of the stylet. For example, portions of the circumference of the stylet may be machined away so as to leave an uneven cylindrical shape with enough space to allow circulation of vacuum or air around the circumference of the stylet. 
         [0026]    According to various aspects, the outside surface  325  of the vacuum line  320  may include asperities and other surface features to provide, for example, space for a lubricant to provide adequate lubrication during insertion and operation of the biopsy device. In addition, the lubricant may prevent a vacuum leak during operation of the biopsy device. According to various aspects, the outside surface  325  of the vacuum line  320  may also be covered with a lubricant  335  such as, e.g., silicone grease, to facilitate movement of the stylet tip  310  and the vacuum line  320  inside the wall of the outer tube or cannula  340  of the biopsy device  300 , and thus to facilitate movement of the stylet tip  310  in and out of the outer tube or cannula  340  to penetrate the skin/tissue of the patient, to remove tissue sample(s), or to rotate inside the outer tube or cannula  340  to remove tissue sample(s). In addition, the lubricant  335  may also act as a vacuum membrane to prevent vacuum from escaping through other portions of the biopsy device  300  and to constrain the path of the vacuum to the paths shown in  FIG. 3A  by the three arrows. 
         [0027]    In  FIG. 3B , the biopsy device  300  includes the stylet tip  310  having the notch  350  connected to the vacuum line  320 . According to various aspects, the outside surface of the vacuum line  320  may have surface features  325  of various sizes to provide, for example, space for adequate lubrication of the stylet tip  310  during insertion and operation of the biopsy device, and the surface features  325  may be configured to fit against the inner wall of the outer tube or cannula  340  of the biopsy device. In addition, grooves  335  may also be provided on the surface of the stylet tip  310  between the surface features  325  to receive, for example, lubricant to facilitate movement and/or rotation of the stylet tip  310  inside the outer tube or cannula  340  and to provide a vacuum membrane. 
         [0028]      FIG. 3C  illustrates another aspect of the current invention, where a conduit  345  provides an air/vacuum communication between the notch  350  and the vacuum line  320 . Accordingly, the vacuum provided via the vacuum line  320  can be transmitted to the notch  350  and can attract an amount of tissue sample into the notch  350  either before the tissue is severed, or after the tissue has been severed. 
         [0029]    In  FIG. 3D , according to various aspects of the current invention, a friction space or clearance  330  may be provided between the vacuum line  320  and the outer tube or cannula  340  to allow the stylet tip  310  and the vacuum line  320  to move and rotate freely inside the outer tube or cannula  340 , resulting in the outside diameter of the vacuum line  320  being smaller than the inside diameter of the outer tube or cannula  340  by an amount sufficient to reduce the friction between the outer tube or cannula  340  and the vacuum line  320 . For example, the clearance between the outside diameter of the vacuum line  320  and the inside diameter of the outer tube or cannula  340  may be in the range of 0.015″. According to various aspects, an asperity  355  may also be provided on the outside surface of the vacuum line  320  to maintain, for example, the clearance  330  between the vacuum line  320  and the outer tube or cannula  340  at a constant value, and may provide space for inserting a lubricant to reduce friction between the vacuum line  320  and the cannula  240  and to also provide sealing of the space between the vacuum line  320  and the cannula  240  and avoid or reduce unwanted vacuum leaks. Additionally, the space between the vacuum line  320  and the cannula  240  can be reduced by crimping the exterior of the cannula  240 . 
         [0030]    In operation, when the stylet tip  310  is inserted into the target tissue, the cannula  340  may be moved forward at a relatively high speed to cover the stylet tip  310 , and as a result sever a tissue sample from the body of the patient. For example, the cannula  340  may be fired forward via a spring which, when activated, may fire the cannula  340  forward to cover the stylet tip  310  and sever a tissue sample. According to various aspects, there are three different types of cannula firing mechanisms: i) manual, where the operator manually pushes the stylet tip  310  forward in the target tissue, and then manually pushes the cannula  340  forward to sever a tissue sample, ii) semi-automatic, where the operator manually pushes the stylet tip  310  forward in the target tissue, and then fires the cannula  340  forward via the spring or firing mechanism, and iii) automatic, where the operator fires both the stylet tip  310  and the cannula  340  forward into the target tissue via the spring or firing mechanism. 
         [0031]      FIGS. 4A-4D  are diagrams illustrating a communication between the vacuum line and the notch in a vacuum-assisted biopsy device, according to various aspects of the current invention. In  FIG. 4A , the biopsy device  400  includes stylet tip  410  and a notch  450  connected to the vacuum line  420  located within the outer wall  440 . According to various aspects, the notch  450  may be connected to the vacuum line  420  via a plurality of air/vacuum lines or microbores  465  that may be thinner than the vacuum line  420 . In the example illustrated in  FIG. 4A , two microbores  465  are illustrated, but those of ordinary skill in the art will recognize that more than two microbores  465  may be present to ensure air and/or vacuum communication between the notch  450  and the vacuum line  420 .  FIG. 4B  illustrates a similar configuration as  FIG. 4A , but with a single microbore  465  between the notch  450  and the vacuum line  420  to ensure air and/or vacuum communication. 
         [0032]    In  FIG. 4C , the biopsy device  400  includes the stylet tip  410  with the notch  450 . According to various aspects of the current invention, the back portion of the stylet tip  410  may include a boss  475  that, in operation, may be fitted into a fitting  470 , the fitting being insertable within the vacuum line  420 . As a result, a vacuum or air communication may be established between the notch  450  and the vacuum line  420  so that the target tissue of a patient being subjected to the biopsy may be drawn in the notch  450  via the vacuum provided from the vacuum line  420 , before and/or after being severed, according to various aspects. In addition, a plurality of pores  480  may be provided in the vacuum line to provide an alternative or additional path for the vacuum to the stylet tip  410 . 
         [0033]    In  FIG. 4D , the back portion of the stylet tip  410  includes the boss  475 , which, according to various aspects, may be directly inserted into the vacuum line  420 . Accordingly, a vacuum or air communication may be established between the notch  450  and the vacuum line  420  so that the tissue sample of a patient being subjected to the biopsy may be drawn into the notch  450  via the vacuum provided via the vacuum line  420 . According to various aspects, openings  485  may be provided in the vacuum line  420  to provide an alternative or additional vacuum path to the stylet tip  410  during insertion and operation of the biopsy device. 
         [0034]      FIGS. 5A-5D  are diagrams illustrating vacuum valves in a vacuum-assisted biopsy device, according to various aspects of the current invention. In  FIG. 5A , a valve  570  includes a pinch valve, where a portion of the vacuum line  520  may be pinched in order to block or release passage of vacuum or air.  FIG. 5B  illustrates another type of valve  540  that is based on a duck bill  545 , according to various aspects of the current invention. It should be noted that although the above valves have been illustrated, other types of valves may also be used to regulate the air or vacuum communication between the vacuum line  420  and the notch  450  in order to ensure a large draw of tissue sample into the notch  450  and provide larger tissue samples than the samples collected using conventional biopsy devices for biopsy analysis. 
         [0035]    While aspects of this invention have been described in conjunction with the example features outlined above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that are or may be presently unforeseen, may become apparent to those having at least ordinary skill in the art. Accordingly, the example aspects of the invention, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and thereof. Therefore, aspects of the invention are intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and/or substantial equivalents.

Technology Category: a