Biopsy device arming mechanism

Abstract

A biopsy device includes an elongated housing containing a stylet hub and a cannula hub. Each of the stylet and cannula hubs are movable between a proximal, armed position, and a distal, fired position. Each of the stylet hub and the cannula hub have a strike configured to retain the respective hub in its proximal, armed position. An arming member is moveably mounted to the housing and configured to move the stylet and cannula hubs to their respective proximal, armed positions. The housing includes a first deflectable wall portion, and when the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the first deflectable wall portion, enabling release of the cannula hub from its proximal, armed position by actuation of the first deflectable wall portion.

Description

BIOPSY DEVICE ARMING MECHANISMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 514,546, filed July 19, 2023, the entire contents of which is incorporated by reference herein.FIELD

[0002] The present disclosure generally relates to the field of tissue sampling and harvesting. More specifically, the disclosure relates to biopsy needle sets and devices.BACKGROUND

[0003] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described in any way.

[0004] In the practice of diagnostic medicine, it is often necessary or desirable to perform a biopsy, or to sample selected tissue from a living patient for medical evaluation. Cytological and histological studies of the biopsy sample can then be performed as an aid to the diagnosis and treatment of disease. Biopsies can be useful in diagnosing and treating various forms of cancer, as well as other diseases in which a localized area of affected tissue can be identified.

[0005] Biopsies are routinely performed on tissue using a needle set, which typically includes an inner needle / stylet with a pointed tip and an aperture / notch defined near its distal end. The stylet is slidably disposed within an outer cannula so that the notch can be alternately exposed or covered. Typically, a hub is connected to the proximal end of each needle. Such needle sets are used with or incorporated in various forms of biopsy devices, such as the single action and double action biopsy devices.

[0006] Currently, there are several soft tissue biopsy devices which are classified as Spring Loaded Core biopsy devices. These all share the characteristics of employing springs to create force and movement in needle cannulas axially to selectively remove a sample of the tissue. These devices are required to have the springs loaded, or armed, manually to compress and lock the springs in a compressed state to prepare for actuating the device. As the device is actuatedthe cannula moves rapidly forward to cut through tissue adjacent to the needle and contain it within the cannula until it is retrieved by the clinician.

[0007] Many of the current devices available are deficient in that they are difficult for users to arm and actuate the device and otherwise use the device due to ergonomic factors. For example it is highly desired for the user (usually a physician) to arm the device using a single hand since the other hand is frequently needed to hold other devices. Many current devices cannot be armed easily with a single hand. In addition, many users with smaller than average hands may not be able to arm devices designed for larger hands and also may not be able to arm the device with one hand. Many of the devices are designed so that a single finger is used to arm the device which can be difficult to do because of the force required. Since the action of arming the device is the same action required to withdraw the outer cannula to access the excised tissue sample, the “arming motion” is done three times per sample (twice to arm the device and once to access the excised tissue sample). When the arming motion cannot be done with a single hand or without difficulty, it presents a significant challenge to the user during the medical procedure. Other devices require compression of elements with the fingers in an extended state which makes it difficult because it is not possible to generate as much force in an extended state as it is with the hand un-extended (e.g. with the hand held in a “C” shape). Some devices have arming features which spring forward and may hit and pinch parts of the hand or patient. In addition, it may be advantageous to arm the device using other surfaces besides the hand and use the muscles of the arm instead to more easily compress the springs.

[0008] Another issue is the inability to actuate (i.e., fire) the device easily in-use. Some devices have buttons that cannot be reached easily or require a motion that may disturb the placement of the device which may decrease accuracy of the tissue targeting. The actuation button can be difficult to depress due to the location of the button and / or the force required. In addition it is often desired to have the ability to acquire the tissue in two distinct steps for safety and efficacy reasons. In this case two or more buttons may be needed. Current devices have buttons that may be mistaken from each other due to similar shape and / or position. Current actuation buttons may be unintentionally depressed during handling because they are protruding and can be depressed with pressure coming from unintended contact with a hand surface and / orcan be depressed easily with low force. A misfire can be unsafe or compromise the acquisition of tissue.

[0009] In addition, different user’s actuate buttons in different ways, apply more or less pressure, applying pressure to the button directly or from the side, etc. Providing actuation controls that allow for consistent firing and control of the firing process can eliminate this user bias.SUMMARY

[0010] The present disclosure addresses one or more of the above-mentioned problems and / or achieves one or more of the above-mentioned desirable features. Other features and / or advantages may become apparent from the description which follows.

[0011] In accordance with one aspect of the present disclosure, a biopsy device includes an elongated housing having a proximal end and a distal end, a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position. The stylet hub has a stylet hub strike configured to retain the stylet hub in its proximal, armed position. A cannula hub is slidably mounted in the housing and is movable relative to the housing between a proximal, armed position, and a distal, fired position. The cannula hub has a cannula hub strike configured to retain the cannula hub in its proximal, armed position. The biopsy device also includes an arming member moveably mounted to the housing and configured to move the stylet and cannula hubs to their respective proximal, armed positions. The housing includes a first deflectable wall portion proximate to the distal end of the housing. When the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the first deflectable wall portion, enabling actuation of the first deflectable wall portion to release the cannula hub from its proximal, armed position and propel the cannula hub in the distal direction.

[0012] In accordance with another aspect of the present disclosure, a biopsy device includes an elongated housing, a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position,the stylet hub having a stylet strike, and a cannula hub slidably mounted in the housing alongside the stylet hub, wherein the cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position. The cannula hub has a cannula strike. The biopsy device also includes a spring-biased arming member moveably mounted to the housing proximal of the respective stylet and cannula hubs. The stylet strike and the cannula strike are aligned when in the armed position and, when in the armed position, the stylet strike and the cannula strike are positioned below an actuatable portion of the housing.

[0013] Additional objects and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present teachings. At least some of the objects and advantages of the present disclosure may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0014] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure and claims, including equivalents. It should be understood that the present disclosure and claims, in their broadest sense, could be practiced without having one or more features of these exemplary aspects and embodiments.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some exemplary embodiments of the present disclosure and together with the description, serve to explain certain principles. These drawings depict only typical embodiments of the disclosed inventions and are not therefore to be considered limiting of its scope. In the drawings:

[0016] FIGS. 1A, IB, and 1C are isometric top views of an embodiment of a spring loaded core biopsy device showing the device in an armed position, a partially fired position, and a fully fired position, respectively.

[0017] FIGS. 2A-2D are various views of an embodiment of an upper cover of the spring loaded core biopsy device of FIGS. 1A-1C.

[0018] FIG. 3A is an enlarged perspective view of a distal portion of the upper cover of FIGS. 2A-2D.

[0019] FIG. 3B is a top view of an actuation button of FIG. 3 A.

[0020] FIG. 3C is a perspective cross sectional view of the distal portion of the upper cover of FIG. 3 A.

[0021] FIG. 3D is a perspective cross sectional view of the distal portion of the upper cover of FIG. 3A taken from the opposite side of the view shown in FIG. 3C.

[0022] FIG. 4 is a top perspective view of a first alternate embodiment of an upper cover for the spring loaded core biopsy device of FIGS. 1 A-1C.

[0023] FIG. 5 is a top perspective view of a second alternate embodiment of an upper cover for the spring loaded core biopsy device of FIGS. 1A-1C.

[0024] FIG. 6 is a top perspective view of a third alternate embodiment of an upper cover for the spring loaded core biopsy device of FIGS. 1A-1C.

[0025] FIGS. 7A and 7B are perspective views of the inner (stylet) cannula hub and the outer cannula hub, respectively, slidably mounted in the spring loaded core biopsy device of FIGS. 1A-1C.

[0026] FIGS. 8A-8C are side perspective views of the spring loaded core biopsy device of FIGS. 1A-1C with the upper cover removed, showing the device in an armed position, a partially fired position, and a fully fired position, respectively.

[0027] FIGS. 9A and 9B are partial cross sectional side views of the upper cover portion of the spring loaded core biopsy device of FIGS. 1A-1C, showing a sequence for firing the inner (stylet) cannula (FIG. 9A) and the outer cannula (FIG. 9B) using the automatic button. As used herein the term “automatic” in the context of the automatic button of the disclosed biopsy devices means that the actions (i.e., firing of the cannulas 104 and 106 of the biopsy devices) happens substantially sequentially.

[0028] FIGS. 10A-10D are partial perspective side views of the upper cover portion of the spring loaded core biopsy device of FIGS. 1A-1C with a portion of the upper cover removed for clarity to illustrate relative positions of the inner (stylet) cannula hub (in blue) and the outer cannula hub (in green) during a firing sequence of the biopsy device, with FIG. 10A showing aview of the inner (stylet) cannula hub and strike (in blue) and the outer cannula hub and strike (in green) in the armed position, FIG. 10B showing the inner and outer cannula hubs after the inner (stylet) cannula has been fired and before the outer cannula has been fired, FIG. IOC illustrates actuation of the automatic button and protrusion to engage a cantilever portion of the inner cannula hub to thereby actuate the outer cannula strike and fire the outer cannula; and FIG. 10D illustrates the same process as FIG. IOC but provides a view from the opposite side of the biopsy device.

[0029] FIGS. 11A and 11B are partial cross sectional side views of the upper cover portion of the spring loaded core biopsy device of FIGS. 1A-1C, showing a sequence for firing the inner (stylet) cannula (FIG. 11 A) using the delay button and the outer cannula (FIG. 11B) using the automatic button.

[0030] FIG. 12 is a perspective view of a shaft for use in arming the biopsy device in accordance with the present teachings.

[0031] FIG. 13 is a side longitudinal cross-sectional view of the distal ends of a needle and a cannula of a spring loaded core biopsy device according to one embodiment.

[0032] FIGS. 14 and 15 are side longitudinal cross-sectional views of the distal ends of a needle and a cannula of a spring loaded core biopsy device according to another embodiment.

[0033] FIG. 16 is a side longitudinal cross-sectional view of the distal ends of a needle and a cannula of a spring loaded core biopsy device according to another embodiment.

[0034] FIG. 17 is a side longitudinal cross-sectional view of the distal ends of a needle and a cannula of a spring loaded core biopsy device according to another embodiment.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0035] Spring-loaded core biopsy devices employ springs to create force and movement in needle cannulas axially to selectively remove a tissue sample e. These devices are required to have the springs loaded, or armed, manually to compress and lock the springs in a compressed state to prepare for actuating the device. In order to successfully capture a tissue sample, an inner cannula or stylet, which may for example include a sharpened tip to maximize tissue penetration, is deployed prior to deploying an outer cannula. By deploying the inner cannula or stylet first, awindow or aperture in the stylet is fully exposed within the tissue before the outer cannula is fired. This allows the option of imaging a position of the stylet and, in particular, the aperture of the stylet, in the tissue prior to firing the outer cannula to obtain the tissue sample. In some embodiments, the inner and outer canula may also incorporate markings that are visible under ultrasound in order to identify a distal portion of the inner cannula and aperture. As the outer cannula is actuated, the outer cannula moves rapidly forward to cut through tissue adjacent to the stylet and contain it within the inner cannula until it is retrieved by the clinician.

[0036] Recent improvements to spring loaded core biopsy devices provide more ergonomic and user-friendly form factors, permitting single-handed arming and actuation of the devices. Various embodiments and examples of such devices, and their arming and firing mechanisms, are disclosed, for example, in U.S. Application No. 14 / 555,531, which was filed on November 26, 2014, issued as U.S. Patent No. 9,585,639 on March 7, 2017, and is entitled “Biopsy Device Arming Mechanism.” The entire content of U.S. Patent No. 9,585,639 is incorporated herein by reference.

[0037] As the actuation mechanisms of such spring loaded core biopsy devices are manually fired by a user, the actuation mechanisms are subject to varying forces and loads which may be applied from different directions based on the user’s habits, i.e., the actuation is subject to user bias. To remove user bias and ensure a consistent actuation and a proper sequence of firing of the inner and outer cannulas, the present disclosure provides structural components and an arrangement of elements that prevent the inner cannula, or stylet, and the outer cannula from firing together or simultaneously. The hubs for the inner cannula and the outer cannula are formed and positioned within the housing of the cannula in a manner that requires that the inner cannula is fired before the outer cannula can be fired. In one example embodiment, firing of the inner cannula, or stylet, moves a stylet hub from an armed position to a fired position, placing a portion of the stylet hub in position over a portion of an outer cannula hub. Without this positioning of the stylet hub over the outer cannula hub, the actuator cannot engage the outer cannula hub to fire the outer cannula. This structural arrangement ensures that the inner and outer cannulas are sequentially fired.

[0038] In accordance with another aspect of the present disclosure, an automatic button is provided to initiate a two-step firing sequence of firing the inner cannula and subsequently firing the outer cannula. In some example embodiments, the automatic button is overmolded and integrally formed with the housing of the biopsy device. An integrally molded body improves manufacturability of the device. In addition, the integral structure improves the robustness of the device as the button and actuator move together. In other example embodiments, the automatic button is sized and shaped to facilitate actuation of the button. For example, the automatic button may have a concave surface that allows a better grip by a finger or thumb of a user actuating the button, which will provide smoother actuation by reducing / preventing slippage of the finger during actuation.

[0039] FIGS. 1A-1C depict a spring loaded core biopsy device 10 in various stages of arming and firing according to an example embodiment. The device 10 depicted in FIG. 1A is in an armed configuration, in FIG. IB an inner cannula (or “stylet”) 106 has been fired while an outer cannula 104 remains in an armed configuration and has not been fired. In FIG. 1C, both the inner and outer cannulas 106 and 104 have been fired. Device 10 includes a distally facing arming button (or “arming member”) 110 having a distal surface 50. The device 10 also includes a body 16 having a proximal surface 52. In order to arm the device 10, a user grasps the device 10 with the proximal surface 52 of the body 16 in the palm of a hand and fingers of the hand on the distal surface 50 of the arming button 110. Then, the user squeezes the arming button 110 twice to arm the device 10. This motion can be accomplished in multiple ways.

[0040] In the embodiment depicted in FIGS. 1A-1C, the inner cannula / stylet 106 can be fired independently of the outer cannula 104 by depressing / actuating the smaller button 12, which may be referred to as the “delay” button as actuation of this button alone delays the completion of the firing sequence as only the inner cannula 106 is fired. After actuation of the smaller, delay button 12, which is located toward the more proximal end of the device 10, the outer cannula 104 can then be advanced by pressing a larger, more distally located button 14, which may be referred to as the “automatic” button, to excise tissue prolapsing into the aperture in the inner cannula 106 (described below). Alternatively, both the inner cannulal06 and the outer cannula 104 can be fired sequentially by only depressing the larger, more distal automatic button 14 (describedbelow). To recover samples from the aperture, the user depresses / actuates the arming button 110 a single time to expose the aperture and arm the outer cannula 104. To perform further biopsies, the arming button 110 is depressed / actuated once more, and the device 10 is fully armed again and ready to acquire tissue.

[0041] Single handed usability:

[0042] In the device 10 depicted in FIGS. 1A-1C, the arming button 110 is adjacent to the proximal end of the device 10 and employs multiple fingers. Therefore, the device 10 can be armed or the outer cannula 104 can be retracted to expose tissue in the aperture with one hand in a non-extended position using a compressive arming stroke, even for users with small hands. This is in contrast to an extending arming stroke, which requires two hands. The device 10 is symmetric in two planes (two perpendicular planes passing through the longitudinal axis of the device 10) for easy use with both hands and for easier access of the fingers to the arming button 110. It can be easily transitioned from arming to acquiring / firing positions. The reach required for arming the device 10, for example, is only about 2.25 or 1.3 inches compared to 4 inches or more of existing devices biopsy devices. This difference, in the reach required to arm the device, is significant in relation to the span of a user’s hand. This allows the contemplated device 10 to be armed with a single hand more easily because of improved hand control, while also increasing the force / strength generated by the hand in the arming position.

[0043] Actuating / firing the device:

[0044] The device depicted in FIGS. 1A-1C is actuated by depressing one or two of the buttons 12, 14 in succession to release internal components. Buttons 12, 14 are depressed normal to a longitudinal axis of the device 10 and in locations that are adjacent to locations where fingers (not shown) and thumbs (not shown) of a hand (not shown) will be present when the device 10 is held by the hand in a natural position. Depressing the buttons 12, 14 normal to the longitudinal axis also minimizes an amount that the depressing motion will disrupt a location of the device 10. In some example embodiments, as discussed above, there is a distinct size difference between the two buttons 12, 14 (such that the delay button 12 is distinctly smaller than the automatic button 14) that serves as a non-visual indicator of button function. In some additional embodiments the larger, automatic button 14 may also have a concave top surface 13that is bordered by a raised edge 15. Such a button geometry not only makes it easier for the thumb of the hand to find and press the automatic button 14, for example by providing a smooth transition without slippage between the delay button 12 and the automatic button 14, but also helps to reduce accidental actuation by helping to limit the movement of the thumb. In one example embodiment, a raised edge encompasses only a portion of the automatic button 14, for example a proximal portion of the button may not have a raised edge, allowing for a smooth transition of the user’s finger or thumb from the delay button 12 to the automatic button 14.

[0045] Noise reduction:

[0046] The device 10 depicted in FIGS. 1A-1C may include features that reduce the sound accompanying firing of the devices. These features include use of contacting surfaces that are not perpendicular to the axis of travel of the inner and outer cannulas 106 and 104, surfaces with more contact area, flexible ribs, and sound energy absorbing materials in the body 16 to muffle the sound, prevent propagation of the energy to the casing and to dampen or absorb the energy, as described below.

[0047] Instead of two surfaces perpendicular to the axis of travel of the inner and outer cannulas contacting to stop distal travel of the cannulas, mating surfaces with conical, angled, hemispherical, parabolic or other non-planar shape can be used. These shapes increase the surface area and also reflect the energy of impact away from the casing, resulting in less sound from the casing.

[0048] Also, energy absorbing material including elastomeric, porous, foam, and polymers with additives that absorb energy can be used to prevent loud sounds from being produced by the device 10. These materials can be disposed in the device 10 so as to cushion the moving parts. Alternatively, the energy absorbing material can absorb sound energy without coming in to contact with the moving parts. The absorbing materials can be used with or without the nonperpendicular surfaces described above.

[0049] The noise produced by the actuation of the biopsy device 10 can be minimized using multiple features including, but not limited to, contact surface geometry, bumpers, and materials. Case materials can be chosen that will dampen a significant portion of the noise produced byimpact of internal parts of the device 10. Bumpers can be disposed on impact surfaces to further dampen the sound produced during operations.

[0050] Aperture orientation:

[0051] It may be desirable for the aperture to face a direction other than the side of the device 10 with the firing buttons 12, 14. This direction can be optimized based on the specific design for physician comfort or preference. The device 10 can include an intuitive indication of the direction of the aperture on the body 16 of the device 10.

[0052] The device 10 can also include an inner cannula 106 (i.e., stylet or needle) that rotates within a case of the device 10 to give the physician his or her choice of aperture orientations. Figures 7A and 7B of U.S. Patent No. 9,585,639 and the related text describe an example mechanism that would allow the physician to change the orientation of the needle aperture, the entire disclosure of this patent is incorporated herein by reference.

[0053] Axial needle concentricity:

[0054] In further embodiments, the inner cannula 106 may be centered within an outer case of the device 10 in both the height and width directions in order to facilitate ease of the physician rotating the device around an axis of the inner cannula 106, while maintaining a position of a needle tip relative to a stationary target. This may allow a clinician to intuitively rotate the device 10 to a desired tissue acquisition aperture location while minimizing unwanted needle motion during targeting.

[0055] Arming feature design:

[0056] The surfaces of the features employed by the user to arm the internal mechanism are within an envelope of an outer case when viewed from an end of the device 10. Because the device 10 does not include features that extend beyond an axial envelope of this outer case, the arming features of the device will not unintentionally contact a patient’s body during a biopsy. Known devices, on the other hand, often have wings or arms that protrude from the device near the biopsy site surface on the patient, and can therefore unintentionally contact the patient’s body during a biopsy. Such unintentional contact can be painful or uncomfortable for the patient, and can be a nuisance for the physician attempting to place the device accurately. Eliminatingfeatures that could contact the patient results in a more comfortable experience for both the patient and the physician during certain procedures with difficult to reach lesions.

[0057] Distal needle support:

[0058] Adding inserts to the case mold or a small spacer to the assembly can create a more precise fit between the inner cannula 106 and the case, by minimizing empty space around the inner cannula or needle 106 at the most distal end of the case. This minimizes movement of the needle 106 relative to the body of the device 10, thereby increasing the accuracy of the needle trajectory when fired. With a large amount of empty space between the needle 106 and the case, the needle 106 can be shifted from the intended axis of trajectory by resistance from the tissue. Movement of the needle 106 can also render it more difficult to advance through tissue manually when targeting a lesion (before firing the needle 106). An insert / spacer that includes an integrated noise reducing bumper component to serve a dual purpose may be positioned around the need 106 as shown and described in U.S. Patent No. 9,585,639, which is incorporated herein by reference in its entirety. Additionally, a spacer could extend past the most distal end of the case (not shown) and perform a tertiary function as a feature for the needle sheath to press fit onto. This feature ensures that the sheath does not unintentionally slip off of the needle.

[0059] Actuation / firing mechanisms:

[0060] FIGS. 2A-2D depict an embodiment of an upper case or cover 16a that forms a part of the device body 16 of biopsy device 10. As shown in FIGS. 2A-2D, the actuation / firing buttons 12, 14 for firing the inner cannula (i.e., stylet or needle) 106 (FIG. IB) and the outer cannula 104 (FIG. 1A) are formed as part of the upper case 16a. FIGS. 2A-2D depict an upper case 16a of the biopsy device 10 having a smaller, firing button 12 (delay button) and a larger, firing button 14 (automatic button). The smaller, firing button 12 is located more proximally on the device body 16 than the larger, firing button 14.

[0061] FIG. 2A is a top view of the upper case 16a, including buttons 12 and 14. FIG. 2B shows the upper case 16a of FIG. 2A with the larger, firing button 14 (automatic button) removed. FIG. 2C is a side view of the upper case 16a and FIG. 2D is a view of the interior of upper case 16a. In various example embodiments, the upper case 16a, which forms a top half of the biopsy device body 16, can snap together with a bottom half of the biopsy device body 16b(see FIGS. 8A-8C) to form the complete biopsy device body 16. FIGS. 3A-3D provide various views of portions of the upper case 16a to better illustrate the structure of the firing buttons 12 and 14. In certain example embodiments, one or both of the buttons 12 and 14 are integrally formed with the upper case 16a.

[0062] As shown in FIGS. 3A and 3B, the buttons 12 and 14 may have different shapes, sizes, and surface contours. For example, in the example embodiment of FIGS. 3 A and 3B, the larger, automatic button 14 has a concave surface 13 to receive a finger for actuation. The edges 15 of the button may also be raised or ridged with respect to the center of the button 14. The button 14 may have a visible indication to identify it as the “automatic” button, for example, the letter “A” may be on the button. In addition to the visible indication of type of use, the shape of the button 14 and / or its size may indicate to a user the intended function of the button 14. Similarly, the smaller, delay button 12 may be smooth, without concavity, to allow the button 12 to be distinguished from the button 14. In addition, the button 12 may be positioned at an angle or have a slope that allows the geometry / structure of the button 12 to be distinguishable from the button 14 by feel. Further, the button 12 may also have a shape that distinguishes the button 12 from the button 14, for example a “D” shape. In addition, the letter “D” may be embossed or cut into a surface 17 of the button 12 to allow a user to perceive the letter “D” on contact (e.g., feel the shape of the letter “D” through touch) with button 12. Any combination of features including shape, size, slope, and texture may be used to help a user identify and distinguish between the buttons 12 (delay button) and 14 (automatic button).

[0063] As shown in FIGS. 2A, 2C, 3C, and 3D, a first deflectable wall portion or first lever 18 is integrally formed with the upper case 16a at a distal end of the lever 18 and extends upward out of the upper case 16a to extend from a distal portion of the upper case 16a in a proximal direction. A proximal free end 18a of the first deflectable wall portion or first lever 18 terminates in the larger, firing button (automatic button) 14. As shown in FIGS. 3C and 3D, a first projection 20 extends from a lower surface 14a of the larger, firing button 14 (i.e., from a lower surface of the free end 18a of the first deflectable wall portion or first lever 18) .

[0064] As shown in FIGS. 2B and 3C, the smaller, firing button 12 is also formed from a portion of the upper case 16a of the biopsy device body 16. The smaller, firing button 12 is formed on asecond deflectable wall portion or second lever 22 that is connected to and extends distally from a proximal portion of the upper case 16a. The second lever 22 is defined by slots 24a and 24b, each of which extend to an open area 26 around a free distal end 22a of the second lever 22 in the top half 16a of the biopsy device body 16. As illustrated in FIG. 3D, a second projection 28 extends from a lower surface of the free distal end 22a of second deflectable wall portion or second lever 22.

[0065] As shown for example in the embodiment of FIGS. 3C, 3D, 9A, 9B, and 10A, the proximal free end 18a of the first lever 18, which includes the larger, firing button (automatic button) 14, overlaps the distal free end 22a of the second lever 22. This configuration of the larger, firing button 14 and the first lever 18 allows actuation / depression of the larger, firing button 14 to actuate the first lever 18 in addition to the second lever 22.

[0066] FIG. 2D illustrates an inner surface of the upper case 16a in which first and second catches 30, 32 are formed on and extend from the inner surface of the upper case the body top half 16a, which are configured to restrain an inner cannula (stylet) hub 34 (see FIG. 7A) and outer cannula hub 40(see FIG. 7B), to thereby arm the inner cannula 106 and the outer cannula 104 (not shown in FIG. 2D), respectively. FIG. 7A shows the stylet hub 34 with a stylet hub strike 36 and a cantilever portion 38. FIG. 7B shows the outer cannula hub 40 with outer cannula hub strike 42. As illustrated in the figures, in some embodiments, the stylet hub strike 36 is thicker (i.e., has more height) than the outer cannula hub strike 42. In this manner, the outer cannula hub strike 42 can accommodate the cantilever portion 38 of the stylet hub 34.

[0067] In some further embodiments, when a respective hub 34, 40 is retracted (i.e., to arm the device 10), it is retracted until it “snaps” into place against the structure that is formed (e.g., the catches 30, 32) in the interior surface of the upper case 16a. In other words, the combination of the catches 30, 32 and the corresponding strikes 40, 42 (of the hubs 34 and 36) create a snap feature, which makes an audible sound when the strikes 40 and 42 engage the catches 30 and 32 under compression. This audible “snapping” sound indicates to a user that the hubs 34 and 36 are each in a fully armed position (i.e., snapped into place against the catches 30 and 32 formed in the interior surface of the upper case 16a).

[0068] FIGS. 4 - 6 illustrate alternate embodiments of the upper case 16a, which forms levers 18 and 22. For example, as shown in FIG. 4, the position of the larger button 14 (automatic button) and smaller button 12 (delay button) may be switched such that the smaller button 12 is distal to the larger button 14. In the alternative embodiment of the upper case 16a shown in FIG. 5, the first lever 18, associated with the automatic button, is positioned side by side with the second lever 22, associated with the delay button. And as shown in FIG. 6, the lever 18, associated with the automatic button, may be parallel to the lever 22, associated with the delay button. The two levers may be connected such that movement of the lever 18 moves the lever 22.

[0069] FIGS. 8A-8C show biopsy device 10 without the upper case 16a to illustrate the positioning of the stylet hub 34 (which is connected to the stylet 106) and the outer cannula hub 40 (which is connected to the outer cannula 104) within the lower case 16b, which forms the lower half of the body 16. Fig. 8A shows the stylet hub 34 (shown in blue) and the outer cannula hub 40 (shown in green) in the armed position. In this position, the stylet hub strike 36 and the outer cannula hub strike 42 are aligned with one another. When viewed in this position, in cross section and relative to the upper case 16a, FIG. 10A shows that the stylet hub strike 36 and the outer cannula hub strike 42 are positioned adjacent to one another, each engaging a respective catch 30, 32, which extend from the upper case 16a on either side of the lever 18 to retain the strikes in the armed position. When in this position, the stylet hub strike 36 and the outer cannula hub strike 42 are positioned below the larger, automatic button 14, with the lever 22 positioned between the automatic button 14 and the stylet hub strike 36.

[0070] In use, when it is desired to fire the stylet 106 without causing the outer cannula 104 to fire, for example to allow imaging of the fired stylet 106 and the position of an aperture (e.g., 206 in FIGS. 13-17) of the stylet 106 before firing the outer cannula 104, the smaller, firing button 12 (delay button) is actuated / depressed to move the second lever 22, thereby applying pressure to the stylet hub strike 36 with the protrusion 28 extending from the bottom surface of the lever 22. When the stylet 106 is in an armed / non-fired position, pushing downward on / applying pressure to the stylet hub strike 36 disengages the stylet hub strike 36 from the catch 30 and fires the stylet 106. This process is illustrated in FIG. 11 A. When the stylet hub strike 36 is released / fired, the stylet hub 34 moves in a distal direction. Movement of the stylet hub 34 inthe distal direction positions the proximal cantilever portion 38 of the stylet hub 34 above the outer cannula hub strike 42 while it is retained by catch 32 (see FIGS. 8B and 10B). Actuating the second lever 22 fires the stylet 106 but does not fire the outer cannula 104. Thus use of the button 12 delays the firing of the outer cannula 104.

[0071] On the other hand, when the larger, firing button (automatic button) 14 is actuated / depressed, both the first and second levers 18, 22 move downward. The proximal end 18a of the larger, firing button 14 engages the second lever 22 by acting on the distal end 22a, thereby releasing the stylet hub strike 36 from catch 30 and causing the firing of inner stylet 106 and the movement of the stylet hub 34 in the distal direction, positioning cantilever portion 38 of stylet hub 34 above the outer cannula hub strike 42, as illustrated in FIGS. 9A-9B. The larger, firing button 14 acts directly on the second lever 22 to move it, thereby causing it to engage and release catch 32, which retained the outer cannula hub strike 42 in the armed position. Because a bottom surface 14a of the first lever 18 is higher than a bottom surface 12a of the second lever 22, actuating / depressing the larger, firing button 14 first acts on the second lever 22 and releases the stylet hub strike 36, then acts on the lever 22 and the cantilever portion 38 of the stylet hub 34, which engages and releases the outer cannula hub strike 42. When both the stylet 106 and the outer cannula 104 are in their respective armed / non-fired positions, sequentially releasing the stylet hub strike 36 and the outer cannula hub strike 42 sequentially fires the stylet 106 and the outer cannula 104. When the stylet 106 has been fired (e.g., by actuating / depressing the smaller, firing button 12) and the outer cannula 104 is in an armed / non-fired position, depressing the larger, firing button 14 fires only the outer cannula 104.

[0072] Arming mechanisms:

[0073] Various mechanisms and methods for arming a biopsy device in accordance with the present disclosure are disclosed in U.S. Patent No. 9,585,639, the entire content of which is incorporated herein by reference. In one example embodiment, biopsy device 10 is armed by moving an arming button 110 in a proximal direction (see, for example, FIGS. 1A-1C).

[0074] In one example embodiment, an assembly for sequentially arming the outer cannula 104 and the inner cannula or stylet 106 includes an arming body 101, having a resilient shaft 100, and which is operably coupled to an arming button 110 (see FIGS. 1A-1C and 8A-8C) thatis operable by a user. The assembly also includes the outer cannula hub 40, which is operably coupled to the outer cannula 104. The outer cannula hub 40 includes the outer cannula strike 42 disposed along a first edge of a travel path of the shaft 100. Further the assembly includes the stylet hub 34, which is operably coupled to the stylet 106. The stylet hub 34 includes the stylet strike 36 disposed along a second opposite edge of the travel path of the shaft 100. When both the outer cannula 104 and stylet 106 are in their respective fired / unarmed positions, the stylet hub strike 36 is disposed adjacent to the outer cannula strike 42 (see FIG. 8C).

[0075] A distal edge 42a of the outer cannula hub strike 42 forms a wedge / ramp with a high end adjacent the first edge of the travel path of the shaft 100 and the low end away from the first edge. A distal edge 36a of the stylet hub strike 36 forms a wedge / ramp with a high end adjacent a second edge of the travel path of the shaft 100 (adjacent a second recess 122 in the shaft 100, which is described below) and the low end away from the second edge. Distal edge 36a of the stylet hub strike 36 is positioned even with the distal edge 42a of the outer cannula hub strike 42.

[0076] The proximal end 118 of the shaft 100 is enlarged forming first and second catches 32, 30 configured to receive the respective distal edges 42a, 36a of the outer cannula hub strike 42 and the stylet hub strike 36. The arming process is generally performed in two steps, first depressing the arming member 110 of the biopsy device 10 toward a proximal end of the housing to compress the arming member 110 and simultaneously move the outer cannula hub 40 and outer cannula hub strike 42 to engage on catch 32 formed on an inner surface of the upper casing 16a. Subsequently the arming member 110 is compressed a second time as it is moved toward the proximal end of the housing, simultaneously moving the stylet hub 34 and stylet hub strike 36 to engage on catch 32 formed on the inner surface of the upper casing 16a.

[0077] Removing tissue from biopsy device:

[0078] Spring loaded core biopsy devices, such as, for example, device 10 are used to remove a sample of tissue from the patient for pathology (e.g., to determine whether cancerous cells are present). Typical spring loaded core devices have a needle 202 with an aperture 206 (e.g., a slot) cut into it, and the needle 202 is disposed coaxially within a cutting cannula 204 having a sharpened distal edge 208. During a biopsy, the tissue prolapsed into the aperture 206 is severed by the cannula 204 as the cannula 204 translates over the aperture 206, forming a core of excisedtissue 210. The cannula 204 is then retracted, exposing the excised tissue 210 contained in the aperture 206. The tissue is then removed from the aperture 206 and placed in fixative and analyzed.

[0079] There are several known methods for removing the excised tissue 210 from the aperture 206, including scraping the needle against an edge or the interior of a collection container, picking up with forceps and depositing into a collection container, shaking or tapping of the needle to dislodge the excised tissue 210 into a collection container, or wiping the tissue specimen onto a piece of gauze and depositing into a collection container. Known methods for removing the excised tissue 210 from the aperture 206 can be time-consuming, but the excised tissue 210 must be removed from the aperture 206 before additional tissue can be biopsi ed. Further, all of the above-described known methods risk dropping or otherwise contaminating the excised tissue core 210 during transfer into the collection container.

[0080] FIGS. 13-17 illustrate various embodiments for removing excised tissue 210 from an aperture 206 of a spring loaded core device 200, device 200 may, for example, have similar components to that of device 10 discussed above. FIG. 13 depicts an embodiment of a spring loaded core device 200 in which an aperture 206 in an inner cannula (i.e., needle or stylet) 202 is coated with a lubricious material 212 that resists adherence of the tissue to the aperture 206. Fatty tissue is the typical tissue that adheres to the aperture 206 in metallic needles 202. Accordingly, the lubricious material 212 coating may be oleophobic, hydrophobic, or both.

[0081] FIGS. 14 and 15 depict another embodiment in which the spring loaded core device 200 includes a pushing device 214 configured to remove the excised tissue core 210 from the aperture 206 by mechanically pushing and / or scraping. The pushing device 214 includes a scoop, spatula, or other shaped body 216 disposed in the aperture 206 and having a proximal end coupled to an elongate body 218 (e.g., a thin wire), which runs along the length of the spring loaded core device 200 in an annular space 220 between the needle 202 and an outer cannula 204. As shown in FIG. 15, the scoop / spatula / shaped body 216 can be advanced distally using the elongate body 218 to dislodge / eject the excised tissue core 210 from the aperture 206. After dislodging or ejecting the excised tissue core 210, the scoop / spatula / shaped body 216 can beretracted into the annular space 220. Alternatively, the scoop / spatula / shaped body 216 can sit (substantially flush) against the proximal end of the aperture 206 when not in use.

[0082] FIGS. 16 and 17 depict two related embodiments of spring loaded core devices 200 that use a flushing fluid 222, such as saline, to flush the excised tissue core 210 from the aperture 206 and into a collection vial (not shown). In the embodiment depicted in FIG. 16, the flushing fluid 222 is pushed distally through the spring loaded core device 200 in the annular space 220 between the needle 202 and the outer cannula 204. A port (not shown) on the spring loaded core device 200 can be attached to a syringe (not shown) filled with the flushing fluid 222 to provide the flushing fluid 222 under pressure. In the embodiment depicted in FIG. 17, the flushing fluid 222 is pushed distally through the spring loaded core device 200 in the lumen 224 of a hollow needle 202. This embodiment provides a more direct flow of the flushing fluid 222 into the aperture 206 to flush the excised tissue core 210 therefrom.

[0083] Examples

[0084] Illustrative examples of the biopsy devices are provided below. Embodiments of the biopsy devices described herein may include any one or more, and any combination of, the clauses described below:

[0085] Claus 1. A biopsy device, comprising: an elongated housing having a proximal end and a distal end; a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the stylet hub having a stylet hub strike configured to retain the stylet hub in its proximal, armed position; a cannula hub slidably mounted in the housing, wherein the cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the cannula hub having a cannula hub strike configured to retain the cannula hub in its proximal, armed position; and an arming member moveably mounted to the housing and configured to move the stylet and cannula hubs to their respective proximal, armed positions; wherein the housing includes a first deflectable wall portion proximate to the distal end of the housing, andwhen the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the first deflectable wall portion, enabling actuation of the first deflectable wall portion to release the cannula hub from its proximal, armed position and propel the cannula hub in the distal direction.

[0086] Clause 2. The biopsy device of clause 1, wherein the housing further includes a second deflectable wall portion proximate to the proximal end of the housing, a free end of the first deflectable wall portion extending over a free end of the second deflectable wall portion.

[0087] Clause 3. The biopsy device of clause 2, wherein, when the stylet hub and the cannula hub are in their proximal, armed positions, actuation of either of the first and the second deflectable wall portions will release the stylet hub from its proximal, armed position to propel the stylet hub in a distal direction.

[0088] Clause 4. The biopsy device of clause 1, wherein the portion of the stylet hub positioned between the cannula strike and the first deflectable wall portion is a cantilevered portion of the stylet hub.

[0089] Clause 5. The biopsy device of any one of clauses 1-4, wherein an actuator of the first deflectable wall portion has a concave surface.

[0090] Clause 6. The biopsy device of any one of clauses 2-5, wherein an actuator of the second deflectable wall portion has a surface that is sloped.

[0091] Clause 7. The biopsy device of clause 6, wherein the sloped surface includes an embossed symbol.

[0092] Clause 8. The biopsy device of any one of clauses 1-7, wherein the arming member is spring-biased and is configured for manually actuated movement from a relaxed, extended position to a loaded, compressed position.

[0093] Clause 9. The biopsy device of clause 8, wherein the arming member is positioned proximally of the stylet hub and the cannula hub.

[0094] Clause 10. The biopsy device of any one of clauses 1-9, wherein the cannula hub and the stylet hub are positioned alongside each other and move relative to each other within thehousing, and wherein the cannula hub and the stylet hub are further configured to be aligned when the cannula hub and the stylet hub are in respective distal, fired positions.

[0095] Clause 11. The biopsy device of any one of clauses 2-10, wherein the first deflectable wall portion includes a first actuator and a first projection and the second deflectable wall portion includes a first section, a second section, and a second actuator, the second section having a second projection extending into the housing.

[0096] Clause 12. The biopsy device of clause 11, wherein, when the first actuator is actuated to propel the stylet hub into its distal fired position, the first actuator contacts and deflects the second section of the second deflectable wall portion so that the second projection engages the stylet hub strike.

[0097] Clause 13. The biopsy device of clause 12, wherein the second section of the second deflectable wall portion has a tapered end and is spaced apart from the first projection of the first deflectable wall portion.

[0098] Clause 14. The biopsy device of clause 2, wherein a first actuator is integrally formed with the first deflectable wall portion and a second actuator is integrally formed with the second deflectable wall portion.

[0099] Clause 15. The biopsy device of clause 14, wherein the first actuator is a first button and the second actuator is a second button.

[0100] Clause 16. The biopsy device of clause 15, wherein the first button is larger than the second button.

[0101] Clause 17. The biopsy device of clause 15, wherein the first button has a concave surface.

[0102] Clause 18. The biopsy device of clause 17, wherein the first button includes a raised edge distal edge.

[0103] Clause 19. The biopsy device of any one of clauses 1-18, wherein the arming member is configured to retract the stylet hub and / or the cannula hub until an interior structure of the housing engages a respective strike of the stylet hub or the cannula hub.

[0104] Clause 20. The biopsy device of any one of clauses 1-19, wherein each of the stylet hub and the cannula hub are in compression when in the proximal, armed position.

[0105] Clause 21. The biopsy device of any one of clauses 1-20, wherein a thickness and / or a height of the stylet hub strike is greater than a thickness and / or a height of the cannula hub strike.

[0106] Clause 22. A biopsy device, comprising: an elongated housing; a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the stylet hub having a stylet strike; a cannula hub slidably mounted in the housing alongside the stylet hub, wherein the cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the cannula hub having a cannula strike; and a spring-biased arming member moveably mounted to the housing proximal of the respective stylet and cannula hubs; wherein the stylet strike and the cannula strike are aligned when in the armed position and, when in the armed position, the stylet strike and the cannula strike are positioned below an actuatable portion of the housing.

[0107] Clause 23. The biopsy device of clause 22, wherein the housing is formed by an upper housing portion and a lower housing portion and the actuatable portion of the housing comprises a lever integrally formed in the upper housing portion.

[0108] Clause 24. The biopsy device of clause 22, wherein, when the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the actuatable portion of the housing.

[0109] Clause 25. The biopsy device of clause 22, wherein the biopsy device is configured to prevent firing of the cannula hub until after the stylet hub has moved to the distal, fired position.

[0110] This disclosure described some examples of the present technology with reference to the accompanying drawings, in which some of the possible examples were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples were provided so that this disclosure wasthorough and complete and fully conveyed the scope of the possible examples to those skill in the art.[00111J 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.

[0112] 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).

[0113] This description and the accompanying drawings that illustrate exemplary embodiments should not be taken as limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Furthermore, elements and their associated features that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be included in the second embodiment.

[0114] It is noted that, as used herein, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0115] Further, this description’s terminology is not intended to limit the disclosure. For example, spatially relative terms — such as “beneath,” “below,” “lower,” “above,” “upper,” “forward,” “front,” “behind,” and the like — may be used to describe one element’s or feature’s relationship to another element or feature as illustrated in the orientation of the figures. These spatially relative terms are intended to encompass different positions and orientations of a devicein use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is inverted, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. A device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0116] Further modifications and alternative embodiments will be apparent to those of ordinary skill in the art in view of the disclosure herein. For example, the systems may include additional components that were omitted from the diagrams and description for clarity of operation. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the systems and methods of the present disclosure. It is to be understood that the various embodiments shown and described herein are to be taken as exemplary. Elements and materials, and arrangements of those elements and materials, may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the present teachings may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of the description herein. Changes may be made in the elements described herein without departing from the scope of the present disclosure.

[0117] It is to be understood that the particular examples and embodiments set forth herein are non-limiting, and modifications to structure, dimensions, materials, and methodologies may be made without departing from the scope of the present disclosure. Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with being entitled to their full breadth of scope, including equivalents.

Claims

What is claimed is:

1. A biopsy device, comprising: an elongated housing having a proximal end and a distal end; a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the stylet hub having a stylet hub strike configured to retain the stylet hub in its proximal, armed position; a cannula hub slidably mounted in the housing, wherein the cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the cannula hub having a cannula hub strike configured to retain the cannula hub in its proximal, armed position; and an arming member moveably mounted to the housing and configured to move the stylet and cannula hubs to their respective proximal, armed positions; wherein the housing includes a first deflectable wall portion proximate to the distal end of the housing, and when the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the first deflectable wall portion, enabling actuation of the first deflectable wall portion to release the cannula hub from its proximal, armed position and propel the cannula hub in the distal direction.

2. The biopsy device of claim 1, wherein the housing further includes a second deflectable wall portion proximate to the proximal end of the housing, a free end of the first deflectable wall portion extending over a free end of the second deflectable wall portion.

3. The biopsy device of claim 2, wherein, when the stylet hub and the cannula hub are in their proximal, armed positions, actuation of either of the first and the second deflectable wall portions will release the stylet hub from its proximal, armed position to propel the stylet hub in a distal direction.

4. The biopsy device of claim 1, wherein the portion of the stylet hub positioned between the cannula strike and the first deflectable wall portion is a cantilevered portion of the stylet hub.

5. The biopsy device of any one of claims 1-4, wherein an actuator of the first deflectable wall portion has a concave surface.

6. The biopsy device of any one of claims 2-5, wherein an actuator of the second deflectable wall portion has a surface that is sloped.

7. The biopsy device of claim 6, wherein the sloped surface includes an embossed symbol.

8. The biopsy device of any one of claims 1-7, wherein the arming member is spring-biased and is configured for manually actuated movement from a relaxed, extended position to a loaded, compressed position.

9. The biopsy device of claim 8, wherein the arming member is positioned proximally of the stylet hub and the cannula hub.

10. The biopsy device of any one of claims 1-9, wherein the cannula hub and the stylet hub are positioned alongside each other and move relative to each other within the housing, and wherein the cannula hub and the stylet hub are further configured to be aligned when the cannula hub and the stylet hub are in respective distal, fired positions.

11. The biopsy device of any one of claims 2-10, wherein the first deflectable wall portion includes a first actuator and a first projection and the second deflectable wall portion includes a first section, a second section, and a second actuator, the second section having a second projection extending into the housing.

12. The biopsy device of claim 11, wherein, when the first actuator is actuated to propel the stylet hub into its distal fired position, the first actuator contacts and deflects the second section of the second deflectable wall portion so that the second projection engages the stylet hub strike.

13. The biopsy device of claim 12, wherein the second section of the second deflectable wall portion has a tapered end and is spaced apart from the first projection of the first deflectable wall portion.

14. The biopsy device of claim 2, wherein a first actuator is integrally formed with the first deflectable wall portion and a second actuator is integrally formed with the second deflectable wall portion.

15. The biopsy device of claim 14, wherein the first actuator is a first button and the second actuator is a second button.

16. The biopsy device of claim 15, wherein the first button is larger than the second button.

17. The biopsy device of claim 15, wherein the first button has a concave surface.

18. The biopsy device of claim 17, wherein the first button includes a raised edge distal edge.

19. The biopsy device of any one of claims 1-18, wherein the arming member is configured to retract the stylet hub and / or the cannula hub until an interior structure of the housing engages a respective strike of the stylet hub or the cannula hub.

20. The biopsy device of any one of claims 1-19, wherein each of the stylet hub and the cannula hub are in compression when in the proximal, armed position.

21. The biopsy device of any one of claims 1-20, wherein a thickness and / or a height of the stylet hub strike is greater than a thickness and / or a height of the cannula hub strike.

22. A biopsy device, comprising: an elongated housing; a stylet hub slidably mounted in the housing, wherein the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the stylet hub having a stylet strike; a cannula hub slidably mounted in the housing alongside the stylet hub, wherein the cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the cannula hub having a cannula strike; and a spring-biased arming member moveably mounted to the housing proximal of the respective stylet and cannula hubs; wherein the stylet strike and the cannula strike are aligned when in the armed position and, when in the armed position, the stylet strike and the cannula strike are positioned below an actuatable portion of the housing.

23. The biopsy device of claim 22, wherein the housing is formed by an upper housing portion and a lower housing portion and the actuatable portion of the housing comprises a lever integrally formed in the upper housing portion.

24. The biopsy device of claim 22, wherein, when the stylet hub is in the distal fired position and the cannula hub is in the proximal, armed position, a portion of the stylet hub is positioned between the cannula strike and the actuatable portion of the housing.

25. The biopsy device of claim 22, wherein the biopsy device is configured to prevent firing of the cannula hub until after the stylet hub has moved to the distal, fired position.

Images