Patent ID: 12201278

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

Various embodiments of the disclosed inventions are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. In addition, an illustrated embodiment of the disclosed inventions needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the disclosed inventions and are not therefore to be considered limiting of its scope.

FIGS.1to7depict a biopsy system including a biopsy device10in accordance with one embodiment. The biopsy device10includes a reusable body portion12and a disposable needle portion14. The body portion12includes components configured to perform a tissue biopsy using the needle portion14. These components include a drive assembly configured to drive movement of components of the needle portion14. An exemplary drive system is described in U.S. Provisional Patent Application Ser. No. 62/055,610, filed on Sep. 25, 2014, and assigned to the same assignee as the instant application, the contents of which are incorporated by reference as though fully set forth herein. The drive assembly can include one or more motors known in the art, including electrical, pneumatic or hydraulic motors. The body portion12also includes a controller (e.g., a computer processor) configured to control the motors in the drive assembly and thereby control movement of the components of the needle portion14.

FIGS.8and9depict respective distal portions of the needle portion14.FIG.8shows the outer cannula16without the inner cannula26.FIG.9shows the outer cannula16with a distal portion of the inner cannula26visible through the tissue receiving aperture20. The needle portion14includes an outer cannula16having a distal tissue piercing tip18. The outer cannula defines an outer cannula lumen24, and a tissue receiving aperture20adjacent to the distal tissue piercing tip18and in communication with the outer cannula lumen24. The needle portion14also includes an inner cannula26slidably disposed in the outer cannula lumen24, and having an open distal end28surrounded by an annular cutting blade30. When the inner cannula26is in its distal-most position in the outer cannula lumen24, the inner cannula26closes the tissue receiving aperture20in the outer cannula16.

As shown inFIGS.10and11, a cutting board22is disposed in the outer cannula lumen24distal to the tissue receiving aperture20. The cutting board22is configured to seal the open distal end28of the inner cannula26when the inner cannula26is in contact with the cutting board22. This seal prevents fluids introduced into the outer cannula lumen24from being aspirated through the open distal end28and the inner cannula lumen32, and bypassing the biopsy site. Instead, the fluids are delivered to the biopsy site through the outer cannula lumen24and the tissue receiving aperture20.

As shown inFIGS.12to17, the biopsy device10is configured to be coupled to an introducer34(also included in the biopsy system) defining an introducer lumen36in which the needle portion14is disposed during certain portions of the tissue biopsy procedure. The introducer34includes an introducer hub38at a proximal end thereof and an open distal end40through which a distal end (including the tissue piercing tip18and at least a portion of the tissue receiving aperture20) of the outer cannula16extends during the tissue biopsy procedure. While the introducer hub38is depicted inFIGS.1-7, the distal tubular portion42of the introducer34is omitted in those figures for clarity.

As shown inFIGS.12to17, the introducer hub38is configured to couple the proximal end of the introducer34to a distal end of the body portion12of the biopsy device10in one of two positions. The distal tubular portion42of the introducer34is shown in phantom inFIGS.12to17for clarity. InFIGS.12,14and16, the introducer34is coupled to the body portion12of the biopsy device10in the “standard” position. In the standard configuration, the open distal end40of the introducer34is proximal of the tissue receiving aperture20, as shown inFIG.14. Therefore, the introducer34does not overlay or obscure any portion of the tissue receiving aperture20. With the introducer34in the standard configuration, tissue receiving aperture20is in its full-size, e.g., 20 mm.

InFIGS.13,15and17, the introducer34is coupled to the body portion12of the biopsy device10in the “petite” position. The introducer34can be transitioned between the standard and petite configurations by: (1) detaching the introducer34from the body portion12; (2) rotating the introducer34on the outer cannula16by 180°; and (3) reattaching the introducer34to the body portion12. In the petite configuration, the introducer34is mounted more distally on the outer cannula16compared to the standard configuration, as shown by comparingFIGS.16and17. In the petite petition, a distal portion40of the introducer34overlays and obscures a proximal portion44of the tissue receiving aperture20, thereby reducing the size of the tissue receiving aperture20, as shown inFIG.15. As a result, with the introducer34in the petite configuration, the tissue receiving aperture20has a reduced “petite” size, e.g., 12 mm.

As shown inFIGS.1to7,12,13,15and17, the biopsy device10is also configured to be coupled to an adapter46(also included in the biopsy system). The biopsy device10and the adapter46together form a support structure. The adapter46is in turn configured to be coupled to a stable surface, such as a stereotactic table (not shown), to stabilize the biopsy device10during a biopsy procedure. The adapter46includes proximal and distal detents48,50(best shown inFIG.2), which facilitate attachment of the introducer34to the tissue biopsy device10in the standard and petite configurations, respectively, as described below. Each detent48,50defines a pair of laterally spaced apart detent latches. The distal detent50is located distal of the proximal detent48. The distal detent50is also located above the proximal detent48(seeFIG.2).

FIGS.18to25illustrate the introducer hub38without the distal tubular portion42of the introducer34. As seen in those figures, the introducer hub38includes respective pairs of standard and petite connector arms52,54extending from the bottom and top of the introducer hub38when the introducer34is in the standard configuration. The standard arms52are laterally space apart from each other. Similarly, the petite arms54are laterally space apart from each other. The standard arms52are located proximal of the petite arms54(seeFIG.20). The axial distance between the standard and petite arms52,54is about the same as the axial distance between the proximal and distal detents48,50. The standard arms52are configured to releasably couple to the proximal detent48on the adapter46to releasably couple the introducer34to the adapter46and the biopsy device10in the standard configuration (see e.g.,FIG.16). The petite arms54are configured to releasably couple to the distal detents50on the adapter46to releasably couple the introducer34to the adapter46and the biopsy device10in the petite configuration (see e.g.,FIG.17). As explained above, the introducer34can be transitioned between the standard and petite configurations the rotating 180° about the outer cannula16. While the introducer34in this embodiment is attached to the biopsy device10via the adapter46, in other embodiments, the introducer34may attach directly to the biopsy device10.

As shown inFIGS.18to25, introducer hub38also includes left and right tabs56,58. The directional terms left and right are from the perspective of the user, behind the introducer hub38, when the introducer34is coupled to the body portion12of the biopsy device10in the standard configuration, as shown inFIG.19. The left tab56includes a recess60(best shown inFIG.19) in which a sensor detectable locating element62, e.g., a magnet, is fixedly coupled to the left tab56. The locating element62is configured to be detected by two sensors64,66in a distal end of the body portion12of the biopsy device10, as described below. For instance, the sensors64,66can be Hall Effect sensors if the locating element62is a magnet. The tabs56,58can be squeezed together to open the standard and petite arms52,54to remove the introducer34from the adapter46. The sensors64,66are laterally spaced apart from each other on respective left and right sides of the body portion12of the biopsy device10. The sensors64,66are also axially spaced apart from each other as described below.

FIGS.26to32depict the interaction between the locating element62in the left tab56of the introducer hub38and the sensors64,66in the body portion12of the biopsy device10.FIGS.26to31depict the body portion12of the biopsy device10with certain components omitted and the housing shown in phantom to allow visualization of the left and right sensors64,66(best seen inFIGS.26and29, respectively).

The left sensor64is located more proximally in the body portion12compared to the right sensor66, as shown inFIGS.26,29and32. The axial position of the left sensor64corresponds to the axial position of the left tab56when the introducer34is coupled to the body portion12of the biopsy device10in the standard configuration. As such, when the introducer34is coupled to the body portion12of the biopsy device10in the standard configuration, the locating element62is not only disposed on the left side of the biopsy device10, wherein the left sensor64is located, but the locating element62is also disposed axially adjacent the left sensor64, as shown inFIG.27. On the other hand, the locating element62is disposed on the other side of the body portion12of the biopsy device10from the right sensor66, as shown inFIG.28. Therefore, when the introducer34is in the standard configuration, the left sensor64detects the proximity of the locating element62, and the right sensor66does not detect the proximity of the locating element62. The sensors64,66send respective signals to the controller in the biopsy device10.

The right sensor66is located more distally in the body portion12compared to the left sensor64, as shown inFIGS.26,29and32. The axial position of the right sensor66corresponds to the axial position of the left tab56when the introducer34is coupled to the body portion12of the biopsy device10in the petite configuration. As such, when the introducer34is coupled to the body portion12of the biopsy device10in the petite configuration, the locating element62is not only disposed on the right side of the biopsy device10, wherein the right sensor66is located, but the locating element62is also disposed axially adjacent the right sensor66, as shown inFIG.30. On the other hand, the locating element62is disposed on the other side of the body portion12of the biopsy device10from the left sensor64, as shown inFIG.31. Therefore, when the introducer34is in the petite configuration, the right sensor66detects the proximity of the locating element62, and the left sensor64does not detect the proximity of the locating element62. The sensors64,66send respective signals to the controller in the biopsy device10.

The controller is configured to receive the signals from the left and/or right sensors64,66, which represent location data of the locating element62, and to analyze the signals to determine whether the introducer34has been coupled to the biopsy device10in the standard or petite configuration. When the locating element62is in a proximal position adjacent the left sensor64, the controller determines that the introducer34is coupled the biopsy device10in the standard configuration. In response to that determination, the controller instructs the drive assembly to move (i.e., axially oscillate) the inner cannula26through a standard (oscillation) stroke length, e.g., 23 mm. When the locating element62is in a distal position adjacent the right sensor66, the controller determines that the introducer34is coupled to the biopsy device10in the petite configuration. In response that determination, the controller instructs to drive assembly to move the inner cannula26through a petite stroke length, e.g., 15 mm. In this manner, the orientation and location of the introducer hub38, and therefore the locating element62, relative to the left and right sensors64,66in the biopsy device10automatically determines the stroke length of the inner cannula26. Exemplary mechanisms for adjusting the stroke length of the inner cannula26are described in U.S. Provisional Patent Application Ser. No. 62/055,610, which was incorporated by reference above. If neither of the left or right sensors64,66detect an adjacent locating element62, they send respective signals to the controller. The controller interprets those signals as indicating the lack of a properly installed introducer34, and halts the biopsy procedure.

Alternatively or additionally, signals from the left and/or right sensors64,66(indicating the standard or petite configuration of the introducer34) can cause the controller to instruct the drive mechanism to change the distance the outer and inner cannulas16,26are fired into tissue at the beginning of a biopsy procedure. When the introducer34is coupled to the biopsy device10in the petite configuration, the outer and inner cannulas16,26are retracted and fired a shorter distance than when the introducer34is in the standard configuration. Exemplary mechanisms for adjusting the firing distance of the outer and inner cannulas16,26(between a proximal armed position and a distal fired position) are described in U.S. Provisional Patent Application Ser. No. 62/055,610, which was incorporated by reference above. Retracting and firing the outer and inner cannulas16,26a shorter distance allows the user to insert the tissue piercing tip20of the armed outer cannula18a short distance through the skin and into a petite breast while minimizing the possibility that the tissue piercing tip20of the outer cannula18will be fired through the breast tissue into which it was pre-inserted before firing, as described in U.S. Provisional Patent Application Ser. No. 62/055,610. Firing a pre-inserted outer cannula16, in turn, improves accuracy and reduces tissue damage.

Having described the structure of various components of the biopsy device10, the adapter46and the introducer34, a breast biopsy procedure100using the biopsy device10, the adapter46and the introducer will now be described.FIG.33depicts the steps of a breast biopsy procedure100according to one embodiment. At step102, a user (e.g., a physician and/or a technician working under the direction of a physician) mounts the biopsy device10to the adapter46, which is in turn coupled to a stable surface like a stereotactic surgical table. At step104, the user removes a protective sheath from the biopsy device10. The protective sheath protects the biopsy device10and maintains sterility during shipping and storage. The protective sheath may cover only the needle portion14of the biopsy device10, which will be inserted into the patient.

At step106, the user installs the introducer34onto the biopsy device10via the adapter46. As discussed above, in other embodiments, the introducer34may be coupled to the biopsy device10without coupling to the adapter46. The user can install the introducer34in either the standard or petite configuration based on the patient's history or anatomy. At step108, the user compresses the patient's breast to prepare for the breast tissue biopsy. At step110, the user measures the compressed breast. At step112, the user determines whether the introducer position (and the corresponding tissue receiving aperture size and stroke length) is suitable for the compressed breast.

If the introducer position is suitable, the user performs the breast tissue biopsy procedure100at step116. Performing the procedure100can include initiating a computer controlled procedure. If the introducer position is not suitable, the user rotates the introducer34180° around the outer cannula16to change to the alternate introducer position at step114. In detail, the user first uncouples the introducer hub38from the adapter46without removing the introducer34from the outer cannula16. Next, the user rotates the introducer34180° around the outer cannula16. Finally, the user recouples the introducer hub38to the adapter46with the introducer34in the alternate introducer position (e.g., from standard to petite). Because the introducer remains slidably and rotatably mounted to the introducer34during step114, introducer position can be changed with minimum effort and in a minimum amount of time, while minimizing the probability of contaminating the outer cannula16. After the changing introducer position at step114, the user performs the breast tissue biopsy procedure100at step116, as described above. During the breast tissue biopsy procedure100, the locating element62and the left and right sensors64,66interact to automatically adjust the stroke length to match the aperture size resulting from the introducer position.

Although the procedure100depicted inFIG.33is a breast biopsy procedure, the disclosed biopsy device10and introducer34are suitable for any biopsy procedure that can be including a variable aperture size and stroke length. Similarly, while the introducer34is described as having two positions (i.e., standard and petite), the disclosed introducer34and locating element62are suitable for biopsy procedures with any number of aperture sizes, including a continuously adjustable aperture size. In such embodiments, the locating element62can be configured to interact with one or more sensors configured to determine the longitudinal, axial or rotational position of the locating element62. In response to signals from the one or more sensors, the controller in the biopsy device varies the stroke length to match the aperture.

Although the sensors64,66described herein are configured to detect a position of the introducer34. Similar sensors can be used to detect other aspects of the biopsy device10and to report same to the controller therein. For instance,FIG.35depict a needle portion sensor68(e.g., a Hall Effect sensor) in the body portion12of the biopsy device10. The needle portion sensor68is configured to detect sensor detectable needle portion elements70(e.g., magnets) in the needle portion14of the biopsy device10to determine when a certain type of needle portion14(containing a certain type of outer cannula16) has been attached to the body portion12. When two sensor detectable needle portion elements70are detected by the needle portion sensor68, the needle portion sensor68communicates with the controller for the biopsy device to confirm proximity of a needle portion14including an outer cannula16having a tissue piercing tip18. When only one sensor detectable needle portion element70is detected by the needle portion sensor68, the needle portion sensor68communicates with the controller for the biopsy device to confirm proximity of a needle portion14including an outer cannula16having a blunt tip. When no sensor detectable needle portion elements70are detected by the needle portion sensor68, the needle portion sensor68communicates with the controller for the biopsy device to confirm the lack of a needle portion14in proximity to the body portion12.

Instead of being fired into tissue, blunt outer cannulas are inserted into openings pre-formed in the tissue. Firing blunt outer cannulas can injure the patient and damage the biopsy device. Accordingly, upon detecting the only one sensor detectable needle portion element70, the needle portion sensor68communicates with the controller, which then disables the firing mechanism in the biopsy device10. Alternatively, the needle portion sensor68can detect two sensor detectable needle portion elements70in the needle portion14with a sharp outer cannula, and communicate with the controller to enable the firing mechanism. When the needle portion sensor68detects no sensor detectable needle portion elements70in its proximity, the needle portion sensor68communicates with the controller, which then disables the biopsy device10.

While the sensors64,66and locating element62in the above-described embodiments are Hall Effect sensors and magnets, other embodiments include optical beam break sensors and protruding sensor detectable elements that break the optical beams. While such sensors are binary, the biopsy device can be associated with more than one sensor to enable encoding of more than two states. Given “n” sensors, the number of states that can be identified is 2n.

FIGS.36to44depict a new, original and ornamental design for a needle portion of a two-part biopsy device for use as part of a medical diagnostic or treatment system.

FIG.36is a perspective view of an embodiment of a needle portion of a two-part biopsy device.

FIG.37is a top plan view of the needle portion ofFIG.36.

FIG.38is a bottom plan view of the needle portion ofFIG.36.

FIG.39is a left side elevational view of the needle portion ofFIG.36.

FIG.40is a right side elevational view of the needle portion ofFIG.36.

FIG.41is a front elevational view of the needle portion ofFIG.36.

FIG.42is a rear elevational view of the needle portion ofFIG.36.

FIG.43is a perspective view of the needle portion ofFIG.36attached to a body portion of a two-part biopsy device.

FIG.44is a second perspective view of the needle portion ofFIG.36.

Although particular embodiments of the disclosed inventions have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the present inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made (e.g., the dimensions of various parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments of the disclosed inventions shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.