Biopsy device waiting mechanism

Abstract

The present application relates to a biopsy device that includes an elongate housing that houses a probe hub and a cannula hub. Each of the probe hub and the cannula hub is movable between a proximal firing position and a distal firing position. Each of the probe hub and the cannula hub has an impingement portion configured to hold the respective hub in its proximal to-be-launched position. The priming member is movably mounted on the housing and configured to move the probe hub and cannula hub to their respective proximal priming positions. The housing includes a first deflectable wall portion, and a portion of the probe hub is positioned between the cannula striker and the first deflectable wall portion when the probe hub is in the distal firing position and the cannula hub is in the proximal waiting position, thereby enabling the cannula hub to be released from its proximal waiting position by actuating the first deflectable wall portion.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application US63 / 514,546, filed July 19, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to the field of tissue sampling and collection. More specifically, this disclosure relates to biopsy needle kits and devices. Background Technology

[0004] The chapter titles used in this document are for organizational purposes only and should not be construed as limiting the subject matter in any way.

[0005] In diagnostic medicine practice, biopsies, or the taking of selected tissue samples from a living patient, are frequently required or anticipated for medical evaluation. The biopsy samples can then be subjected to cytological and histological studies to aid in the diagnosis and treatment of disease. Biopsies can be used to diagnose and treat various forms of cancer, as well as to identify other diseases in localized areas of affected tissue.

[0006] Tissue biopsies are routinely performed using needle kits, which typically include an inner needle / probe with a sharp tip and an orifice / notch defined near its distal end. The probe is slidably disposed within an outer cannula, allowing the notch to be alternately exposed or covered. Typically, a hub is attached to the proximal end of each needle. Such needle kits are used with or incorporated into various types of biopsy devices, such as single-action and double-action biopsy devices.

[0007] Currently, several soft tissue biopsy devices are classified as spring-loaded core biopsy devices. These devices all share the following characteristics: they utilize a spring to generate force and movement axially within the needle cannula to selectively extract tissue samples. These devices require manual loading of the spring or spring pre-loaded, compressed, and locked in the compressed state to prepare for actuation. As the biopsy device is actuated, the cannula moves rapidly forward to cut through tissue near the needle and contain the tissue within the cannula until it is removed by the clinician.

[0008] The shortcoming of many available devices is that, due to ergonomic factors, users find it difficult to prepare and actuate the device, and also difficult to use the device in other ways. For example, because the other hand is often needed to hold other devices, users (often doctors) would very much like to prepare the device with one hand. Many existing devices cannot be easily prepared with one hand. In addition, many users with smaller than average hand sizes may not be able to prepare devices designed for large hands, or may not be able to prepare the device with one hand. Many devices are designed to be prepared using a single finger, but this can be difficult to do due to the force required. Since the act of preparing the device is the same as the act required to withdraw the outer cannula to approach the excised tissue sample, each sampling requires three "preparation actions" (two for preparing the device and one for approaching the excised tissue sample). This poses a significant challenge to users during medical procedures when they cannot perform the preparation action with one hand or without difficulty. Other devices require compressing the components with the fingers extended, which is also difficult because it is impossible to generate sufficient force with the fingers extended as it is with the palm closed (e.g., with the hand in a "C" grip). Some devices have a pre-launching feature that pops forward and may impact or pinch the hand or patient's hand. Furthermore, it can be advantageous to use surfaces other than the hand to pre-launch the device, and alternatively, to utilize arm muscles to more easily compress the spring.

[0009] Another problem is that the device is difficult to actuate (i.e., fire) during use. Some devices have buttons that are hard to reach, or the action required to press the button may interfere with device placement, potentially reducing the accuracy of tissue target localization. The actuation button may be difficult to press due to its location and / or the force required. Furthermore, for both safety and effectiveness reasons, the ability to acquire tissue in two distinct steps is often desired. In such cases, two or more buttons may be required. Buttons on existing devices may be accidentally pressed due to their similar shape and / or location. Existing actuation buttons may be accidentally pressed during operation because they are protruding and may be pressed due to unintentional pressure from contact with the hand surface, and / or require only a small force to press. Accidental firing can be unsafe or impair tissue acquisition.

[0010] Furthermore, different users actuate the button in different ways to apply varying degrees of pressure, such as applying pressure directly to the button or from the side. Providing actuation control that allows for consistent firing and control over the firing process can eliminate this user preference. Summary of the Invention

[0011] This disclosure solves one or more of the problems described above and / or achieves one or more of the desired features described above. Other features and / or advantages may become apparent from the following description.

[0012] According to one aspect of this disclosure, a biopsy device includes an elongated housing having a proximal end and a distal end, and a probe hub slidably mounted within the housing, wherein the probe hub is movable relative to the housing between a proximal ready position and a distal firing position. The probe hub has a probe hub impact portion configured to hold the probe hub in its proximal ready position. A cannula hub is slidably mounted in the housing and movable relative to the housing between a proximal ready position and a distal firing position. The cannula hub has a cannula hub impact portion configured to hold the cannula hub in its proximal ready position. The biopsy device also includes a firing member movably mounted to the housing, and the firing member is configured to move the probe hub and the cannula hub to their respective proximal ready positions. The housing includes a first deflectable wall portion located proximal to the distal end of the housing. When the probe hub is in the distal firing position and the casing hub is in the proximal ready-to-fire position, a portion of the probe hub is positioned between the casing impact portion and the first deflectable wall portion, thereby enabling the first deflectable wall portion to be actuated to release the casing hub from its proximal ready-to-fire position and advance the casing hub in the distal direction.

[0013] According to another aspect of this disclosure, a biopsy device includes: an elongated housing; a probe hub slidably mounted within the housing, wherein the probe hub is movable relative to the housing between a proximal firing position and a distal firing position, the probe hub having a probe impact portion; and a cannula hub slidably mounted within the housing and mounted side-by-side with the probe hub, wherein the cannula hub is movable relative to the housing between a proximal firing position and a distal firing position. The cannula hub has a cannula impact portion. The biopsy device further includes a spring-biased firing member movably mounted to the housing, proximal to the respective probe hub and cannula hub. The probe impact portion and the cannula impact portion are aligned in the proximal firing position, and when in the proximal firing position, the probe impact portion and the cannula impact portion are positioned below an actuable portion of the housing.

[0014] Other objects and advantages will be set forth in part in the description which follows, and will be apparent in part from the description, or may be learned by practicing the teachings. At least some of the objects and advantages of this disclosure may be realized and obtained by means of the elements and combinations particularly pointed out in the appended claims.

[0015] It should be understood that both the foregoing general description and the following detailed description are merely exemplary and explanatory, and are not intended to limit this disclosure and the claims (including equivalents). It should be understood that this disclosure and the claims may be practiced in their broadest sense without having one or more features of these exemplary aspects and embodiments. Attached Figure Description

[0016] 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 specification, serve to explain certain principles. These drawings depict only typical embodiments of the disclosed invention and should not be construed as limiting its scope. In the drawings:

[0017] Figure 1A , Figure 1B and Figure 1C This is an isometric top view of an embodiment of a spring-loaded core biopsy device, showing the device in the ready-to-fire, partially fired, and fully fired positions.

[0018] Figures 2A-2D yes Figure 1A-1C Various views of an embodiment of the top cover of a spring-loaded core biopsy device.

[0019] Figure 3A yes Figures 2A-2D An enlarged perspective view of the far side of the top cover.

[0020] Figure 3B yes Figure 3A Top view of the actuation button.

[0021] Figure 3C yes Figure 3A A perspective sectional view of the far side of the top cover.

[0022] Figure 3D yes Figure 3A The far side of the top cover from Figure 3C The perspective section view shown is taken from the opposite side of the view shown.

[0023] Figure 4 yes Figure 1A-1C Top perspective view of a first alternative embodiment of the top cover of a spring-loaded core biopsy device.

[0024] Figure 5 yes Figure 1A-1C A top perspective view of a second alternative embodiment of the top cover of a spring-loaded core biopsy device.

[0025] Figure 6 yes Figure 1A-1C A top perspective view of a third alternative embodiment of the top cover of a spring-loaded core biopsy device.

[0026] Figure 7A and Figure 7B They are respectively slidably installed Figure 1A-1C A perspective view of the inner (probe) hub and outer hub of a spring-loaded core biopsy device.

[0027] Figures 8A-8C yes Figure 1A-1C The side perspective view of the spring-loaded core biopsy device with the top cover removed shows the device in the ready-to-fire, partially fired, and fully fired positions, respectively.

[0028] Figure 9A and Figure 9B yes Figure 1A-1C A partial cross-sectional side view of the upper cover portion of a spring-loaded coring biopsy device, the Figure 9A and Figure 9B This demonstrates the use of an automatic button to fire the inner (probe) sleeve ( Figure 9A ) and outer tube ( Figure 9B The sequence of these actions. In the context of the automatic button of the disclosed biopsy device, the term "automatic" as used herein refers to the fact that these actions (i.e., the firing of the cannulas 104 and 106 of the biopsy device) occur substantially sequentially.

[0029] Figure 10A-10D yes Figure 1A-1C A partial perspective side view of the top cover portion of a spring-loaded coring biopsy device, wherein, for clarity, a portion of the top cover has been removed to illustrate the relative positions of the (probe) sheath hub (blue) and the outer sheath hub (green) during the firing procedure of the biopsy device. Figure 10A The diagram shows views of the inner (probe) sleeve hub and impact section (blue) and the outer sleeve hub and impact section (green) in the ready-to-fire position. Figure 10B The inner sleeve hub and outer sleeve hub are shown after the inner (probe) sleeve has been fired and before the outer sleeve has been fired. Figure 10C The diagram shows an actuation button and protrusion for engagement with the cantilever portion of the inner sleeve hub, thereby actuating the outer sleeve impact portion and firing the outer sleeve; and Figure 10D It shows the relationship with Figure 10C The same procedure, but provides a view from the other side of the biopsy device.

[0030] Figure 11A and 11B yes Figure 1A-1C A partial cross-sectional side view of the top cover of a spring-loaded core biopsy device, showing the use of a delayed button to fire the inner (probe) sheath. Figure 11A ) and using the automatic button to fire the outer tube ( Figure 11B The order of ).

[0031] Figure 12 It is a perspective view of the axis used to prepare the biopsy device according to the teachings of the present invention.

[0032] Figure 13 This is a side longitudinal sectional view of the distal end of the needle and the distal end of the cannula of a spring-loaded core biopsy device according to one embodiment.

[0033] Figure 14 and Figure 15 This is a side longitudinal sectional view of the distal end of the needle and the distal end of the cannula of a spring-loaded core biopsy device according to another embodiment.

[0034] Figure 16 This is a side longitudinal sectional view of the distal end of the needle and the distal end of the cannula of a spring-loaded core biopsy device according to another embodiment.

[0035] Figure 17 This is a side longitudinal sectional view of the distal end of the needle and the distal end of the cannula of a spring-loaded core biopsy device according to another embodiment. Detailed Implementation

[0036] Spring-loaded core biopsy devices use a spring to generate force and movement axially within a needle cannula to selectively retrieve tissue samples. These devices require manual loading of the spring or spring-loaded preparation to compress and lock the spring in a compressed state in preparation for actuation. For successful tissue sample capture, an inner cannula or probe, for example, comprising a sharp tip to maximize tissue penetration, is deployed before the outer cannula. By deploying the inner cannula or probe first, the window or orifice in the probe is fully exposed within the tissue before firing the outer cannula. This allows for the option of imaging the probe's position in the tissue, particularly the orifice, before firing the outer cannula to obtain a tissue sample. In some embodiments, the inner and outer cannulas may also be incorporating markers visible under ultrasound to identify the distal portion of the inner cannula and the orifice. As the outer cannula is actuated, it moves rapidly forward to cut through the tissue near the probe and contain the tissue within the inner cannula until the clinician retracts it.

[0037] In recent years, improvements to spring-loaded core biopsy devices have provided more ergonomic and user-friendly shape factors, allowing for single-handed pre-launching and actuation of the device. For example, various embodiments and examples of such devices and their pre-launching and firing mechanisms are disclosed in U.S. Patent Application US14 / 555,531, filed November 26, 2014, and U.S. Patent US9,585,639, granted March 7, 2017. The entire contents of U.S. Patent US9,585,639 are incorporated herein by reference.

[0038] Because the actuation mechanism of such spring-loaded coring biopsy devices is manually fired by the user, it is subject to varying forces and loads that can be applied from different directions based on user habits; that is, actuation is influenced by user preferences. To eliminate user preferences and ensure consistent actuation and the correct firing sequence of the inner and outer sleeves, this disclosure provides a structural component and element arrangement that prevents the inner sleeve (or probe) and outer sleeve from firing together or simultaneously. The inner sleeve hub and outer sleeve hub are formed and positioned within the sleeve housing, requiring the inner sleeve to be fired before the outer sleeve. In one exemplary embodiment, firing the inner sleeve or probe moves the probe hub from a ready-to-fire position to a firing position, thereby positioning a portion of the probe hub above a portion of the outer sleeve hub. Without this probe hub positioned above the outer sleeve hub, the actuator cannot engage with the outer sleeve hub to fire the outer sleeve. This structural arrangement ensures the sequential firing of the inner and outer sleeves.

[0039] According to another aspect of this disclosure, an automatic button is provided to initiate a two-step firing sequence of firing the inner sleeve and subsequently firing the outer sleeve. In some exemplary embodiments, the automatic button is overmolded and integrally formed with the housing of the biopsy device. The integral molding improves the manufacturability of the device. Furthermore, the integral structure improves the robustness of the device because the button and actuator move together. In other exemplary embodiments, the size and shape of the automatic button are configured to facilitate button actuation. For example, the automatic button may have a concave surface that allows for a better grip by the user's finger or thumb, which provides smoother actuation by reducing / preventing finger slippage during actuation.

[0040] Figure 1A-1C A spring-loaded core biopsy device 10 in various preparatory and firing phases according to an exemplary embodiment is depicted. Figure 1A The device 10 shown is in a ready-to-fire configuration. Figure 1B In the middle, the inner sleeve (or "probe") 106 has been fired, while the outer sleeve 104 remains in a ready-to-fire configuration and has not yet been fired. Figure 1C In this device, both the inner sleeve 106 and the outer sleeve 104 are fired. The device 10 includes a distally facing ready-to-fire button (or "ready-to-fire member") 110 with a distal surface 50. The device 10 also includes a body 16 with a proximal surface 52. To prepare the device 10 for firing, the user holds the device 10 with the proximal surface 52 of the body 16 in the palm of the hand and the fingers of the hand resting on the distal surface 50 of the ready-to-fire button 110. The user then squeezes the ready-to-fire button 110 twice to prepare the device 10 for firing. This action can be performed in several ways.

[0041] exist Figure 1A-1CIn the illustrated embodiment, the inner cannula / probe 106 can be fired independently of the outer cannula 104 by pressing / activating a smaller button 12, which can be referred to as the "delay" button, because actuating this button individually delays the completion of the firing sequence since only the inner cannula 106 is fired. After actuating the smaller delay button 12, located more proximal to the device 10, the outer cannula 104 can then be advanced by pressing a larger button 14, which can be referred to as the "automatic" button, to remove tissue prolapsed into the orifice of the inner cannula 106 (described below). Alternatively, both the inner cannula 106 and the outer cannula 104 can be fired sequentially by pressing only the larger automatic button 14, located more distally (described below). To retrieve a sample from the orifice, the user presses / activates the ready-to-fire button 110 once to expose the orifice and prepare the outer cannula 104 for firing. To perform another biopsy, the ready-to-fire button 110 is pressed / activated again, and the device 10 is fully ready again to obtain tissue.

[0042] One-handed usability:

[0043] exist Figure 1A-1C In the illustrated device 10, the ready-to-fire button 110 is located adjacent to the proximal end of the device 10 and utilizes multiple fingers. Therefore, even for users with small hands, a single-handed, non-extended, compressive ready-to-fire stroke can be used to ready-to-fire the device 10 or retract the outer sheath 104 to expose tissue within the orifice. This contrasts with an extended ready-to-fire stroke requiring both hands. The device 10 is symmetrical in two planes (two perpendicular planes passing through the longitudinal axis of the device 10) to facilitate two-handed use and to make it easier for fingers to access the ready-to-fire button 110. It can easily transition from the ready-to-fire position to the take-off / firing position. For example, the reachable distance required for the ready-to-fire device 10 is only about 2.25 inches or 1.3 inches, while existing biopsy devices require a reachable distance of 4 inches or more. This difference in reachable distance required to ready-to-fire the device is significant for users with varying hand spans. This improved hand control allows for easier single-handed ready-to-fire of the envisioned device 10, while also increasing the force / intensity generated by the hand in the ready-to-fire position.

[0044] Actuation / firing mechanism:

[0045] Figure 1A-1CThe illustrated device is actuated by pressing one or both of buttons 12 and 14 in sequence to release internal components. Buttons 12 and 14 are pressed orthogonally to the longitudinal axis of device 10, and the positions of buttons 12 and 14 are adjacent to the positions of the fingers (not shown) and thumb (not shown) of the hand (not shown) when the hand holds device 10 in a natural posture. Pressing buttons 12 and 14 orthogonally to the longitudinal axis also minimizes the degree of disturbance to the position of device 10 caused by the pressing action. In some exemplary embodiments, as described above, there is a significant size difference between the two buttons 12 and 14 (making the delay button 12 significantly smaller than the automatic button 14), which serves as a non-visual indication of the button's function. In some additional embodiments, the larger automatic button 14 may also have a concave top surface 13 surrounded by a raised edge 15. This 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 rather than slippage between the delay button 12 and the automatic button 14, but also helps reduce accidental actuation by helping to limit the movement of the thumb. In one exemplary embodiment, the raised edge only surrounds a portion of the automatic button 14. For example, the proximal portion of the button may not have a raised edge, thereby allowing the user's finger or thumb to smoothly transition from the delay button 12 to the automatic button 14.

[0046] Noise reduction:

[0047] Figure 1A-1C The illustrated device 10 may include features that reduce the sound generated by the firing of the accompanying device. These features include contact surfaces that are not perpendicular to the travel axes of the inner sleeve 106 and the outer sleeve 104, surfaces with a larger contact area, flexible ribs, and sound-absorbing material in the body 16 to suppress sound, prevent energy from propagating to the outer casing, and dampen or absorb energy, as described below.

[0048] Instead of having two surfaces perpendicular to the travel axes of the inner and outer sleeves contact each other to prevent the sleeve from traveling distally, mating surfaces with tapered, angled, hemispherical, parabolic, or other non-planar shapes can be used. These shapes increase the surface area and reflect impact energy away from the housing, thereby reducing noise generated by the housing.

[0049] Furthermore, energy-absorbing materials, including elastomers, porous materials, foams, and polymers containing energy-absorbing additives, can be used to prevent large sounds from being generated by device 10. These materials can be disposed in device 10 to cushion moving parts. Alternatively, the energy-absorbing material can also absorb sound energy without contacting moving parts. The absorbing material can be used with the aforementioned non-vertical surfaces, or it can be used without the aforementioned non-vertical surfaces.

[0050] Various features can be used to minimize noise generated by the actuation of the biopsy device 10, including but not limited to contact surface geometry, cushioning, and materials. The housing material can be selected to suppress a significant portion of the noise generated by impacts from the internal components of the device 10. Cushions can be placed on the impact surface to further reduce sound generated during operation.

[0051] Orifice orientation:

[0052] It may be desirable for the orifice to face in a direction other than the side of device 10 with firing buttons 12, 14. This orientation can be optimized based on the specific design for the physician's comfort or preference. Device 10 may include a visual indication of the orifice orientation on its body 16.

[0053] Device 10 may also include an inner cannula 106 (i.e., a probe or needle) that rotates within the housing of device 10 to allow a physician to select the orifice orientation. (See US Patent 9,585,639) Figure 7A and 7B The related text describes an exemplary mechanism that would allow a physician to change the orientation of the needle hole, the entire contents of which are incorporated herein by reference.

[0054] Axial needle concentricity:

[0055] In other embodiments, the inner cannula 106 may be centered within the housing of the device 10 in both the height and width directions, allowing the physician to easily rotate the device about the axis of the inner cannula 106 while maintaining the position of the needle tip relative to a fixed target. This allows clinicians to intuitively rotate the device 10 to the desired tissue access orifice while minimizing unwanted needle movement during target localization.

[0056] Design of features to be launched:

[0057] When viewed from one end of the device 10, the surface of the feature to be fired by the user is located within the envelope of the housing. Since the device 10 does not include features extending beyond the axial envelope of this housing, the feature to be fired will not unintentionally come into contact with the patient's body during a biopsy. On the other hand, known devices typically have wing-like or arm-like features protruding from the device near the patient's biopsy site surface, and therefore can unintentionally come into contact with the patient's body during a biopsy. This unintentional contact can cause pain or discomfort to the patient and is problematic for the physician attempting to accurately place the device. Eliminating features that could potentially contact the patient allows for a more comfortable experience for both the patient and the physician during procedures involving lesions that are difficult to access.

[0058] Distal pin support:

[0059] By adding an insert to the housing mold or a small shim to the assembly, a more precise fit between the inner sleeve 106 and the housing can be achieved by minimizing the gap around the inner sleeve or needle 106 at the farthest end of the housing. This minimizes the movement of the needle 106 relative to the body of the device 10, thereby improving the trajectory accuracy when the needle is fired. In the presence of a large gap between the needle 106 and the housing, the needle 106 may deviate from the intended trajectory axis due to resistance from the tissue. Movement of the needle 106 may also make it more difficult to manually advance through the tissue (before firing the needle 106) when targeting lesions. An insert / shim including an integrated noise-reducing buffer can be positioned around the needle 106 to achieve a dual function, as shown and described in U.S. Patent 9,585,639, the entire contents of which are incorporated herein by reference. Furthermore, the shim can extend beyond the farthest end of the housing (not shown) and perform a third function as a feature for press-fitting the needle onto the needle. This feature ensures that the needle sheath does not unintentionally slip off the needle.

[0060] Actuation / firing mechanism:

[0061] Figures 2A-2D An embodiment of an upper housing or cover 16a forming part of the device body 16 of the biopsy device 10 is depicted. (See also...) Figures 2A-2D As shown, 106 is used to fire the inner sleeve (i.e., the probe or needle). Figure 1B ) and outer tube 104 ( Figure 1A The actuation / firing buttons 12 and 14 are formed as part of the upper housing 16a. Figures 2A-2D The upper housing 16a of the biopsy device 10 is depicted, which has a smaller firing button 12 (delay button) and a larger firing button 14 (automatic button). The smaller firing button 12 is located closer to the proximal side on the device body 16 compared to the larger firing button 14.

[0062] Figure 2A It is a top view of the upper housing 16a including firing buttons 12 and 14. Figure 2B Show Figure 2A The upper casing 16a, in which the larger firing button 14 (automatic button) has been removed. Figure 2C This is a side view of the upper outer shell 16a. Figure 2D This is a view of the interior of the upper outer casing 16a. In various exemplary embodiments, the upper outer casing 16a, which forms the upper half of the biopsy device body 16, may be connected to the lower half 16b of the biopsy device body (see [link to documentation]). Figures 8A-8C They are snapped together to form the complete biopsy device body 16. Figures 3A-3DDifferent views of various portions of the upper housing 16a are provided to better illustrate the structure of the firing buttons 12 and 14. In some exemplary embodiments, one or both of the firing buttons 12 and 14 are integrally formed with the upper housing 16a.

[0063] like Figure 3A and Figure 3B As shown, firing buttons 12 and 14 can have different shapes, sizes, and surface profiles. For example, in Figure 3A and Figure 3B In an exemplary embodiment, the larger automatic button 14 has a concave surface 13 to receive a finger for actuation. The edge 15 of the button may also be raised or ridged relative to the center 14 of the actuation button 14. The button 14 may have a visible identifier to identify it as an "automatic" button; for example, the button may have the letter "A". In addition to a visible usage type identifier, the shape and / or size of the button 14 may also indicate to the user the intended function of the button 14. Similarly, the smaller delay button 12 may be smooth and without concavity to allow differentiation from the button 14. Furthermore, the button 12 may be angled or have a slope, allowing its geometry / structure to be tactilely distinguishable from the button 14. Additionally, the button 12 may have a shape that distinguishes it from the button 14, such as a "D" shape. Furthermore, the letter "D" may be embossed or engraved on the surface 17 of the button 12 to allow the user to perceive the letter "D" upon contact with the button 12 (e.g., to feel the shape of the letter "D" by touch). Any combination of features, including shape, size, slope, and texture, can be used to help users identify and distinguish between button 12 (delay button) and button 14 (auto button).

[0064] like Figure 2A , Figure 2C , Figure 3C and Figure 3D As shown, the first deflectable wall portion or the first operating lever 18 is integrally formed with the upper housing 16a at the distal end of the operating lever 18 and extends upward beyond the upper housing 16a, extending from the distal portion of the upper housing 16a in a proximal direction. The proximal free end 18a of the first deflectable wall portion or the first operating lever 18 terminates at a larger firing button (automatic button) 14. Figure 3C and Figure 3D As shown, the first protrusion 20 extends from the lower surface 14a of the larger firing button 14 (i.e., from the lower surface of the first deflectable wall portion or the free end 18a of the first operating lever 18).

[0065] like Figure 2B and Figure 3CAs shown, a smaller firing button 12 is also formed within a portion of the upper housing 16a of the biopsy device body 16. The smaller firing button 12 is formed on a second deflectable wall portion or a second operating lever 22, which is connected to and extends distally from a proximal portion of the upper housing 16a. The second operating lever 22 is defined by slots 24a and 24b, each slot extending into an open area 26 surrounding the free distal end 22a of the second operating lever 22 in the upper half 16a of the biopsy device body 16. Figure 3D As shown, the second protrusion 28 extends from the lower surface of the free distal end 22a of the second deflectable wall portion or the second operating lever 22.

[0066] For example, such as Figure 3C , Figure 3D , Figure 9A , Figure 9B and Figure 10A As shown in the embodiment, the proximal free end 18a of the first operating lever 18 overlaps with the distal free end 22a of the second operating lever 22, the proximal free end including a larger firing button (automatic button) 14. This configuration of the larger firing button 14 and the first operating lever 18 allows the actuation / pressing of the larger firing button 14 to actuate the first operating lever 18 in addition to actuating the second operating lever 22.

[0067] Figure 2D The inner surface of the upper housing 16a is shown, wherein a first capturing member 30 and a second capturing member 32 are formed on and extend from the inner surface of the upper housing 16a of the upper half of the body, and the first capturing member 30 and the second capturing member 32 are configured to restrict the inner sleeve (probe) hub 34 (see...). Figure 7A ) and outer casing hub 40 (see Figure 7B ), thereby enabling the inner sleeve 106 and the outer sleeve 104 to respectively ( Figure 2D (Not shown in the image) To be sent. Figure 7A A probe hub 34 with a probe hub impact section 36 and a cantilever section 38 is shown. Figure 7B An outer tube hub 40 with an outer tube hub impact portion 42 is shown. As shown, in some embodiments, the probe hub impact portion 36 is thicker (i.e., taller) than the outer tube hub impact portion 42. In this way, the outer tube hub impact portion 42 can accommodate the cantilever portion 38 of the probe hub 34.

[0068] In some other embodiments, when the respective hubs 34, 40 retract (i.e., prepare the device 10 for firing), they retract until they are “clicked” into place against structures (e.g., catchers 30, 32) formed in the inner surface of the upper housing 16a. In other words, the combination of catchers 30, 32 with corresponding impact portions 40, 42 (impact portions of hubs 34 and 36) creates a snap-fit ​​feature that produces an audible sound when impact portions 40 and 42 engage with catchers 30 and 32 under compression. This audible “click” indicates to the user that hubs 34 and 36 are in the fully ready-to-fire position (i.e., snapped into place against catchers 30 and 32 formed in the inner surface of the upper housing 16a).

[0069] Figure 4-6 An alternative embodiment of the upper housing 16a is shown, which forms the operating levers 18 and 22. For example, as Figure 4 As shown, the positions of the larger button 14 (auto button) and the smaller button 12 (delay button) can be switched so that the smaller button 12 is located further away from the larger button 14. Figure 5 In an alternative embodiment of the upper housing 16a shown, a first operating lever 18 associated with the automatic button and a second operating lever 22 associated with the delay button are positioned side by side. Figure 6 As shown, the lever 18 associated with the automatic button can be parallel to the lever 22 associated with the delay button. The two levers can be connected so that movement of the lever 18 moves the lever 22.

[0070] Figures 8A-8C The biopsy apparatus 10 without the upper housing 16a is shown to illustrate the positioning of the probe hub 34 (which is connected to the probe 106) and the outer casing hub 40 (which is connected to the outer casing 104) within the lower housing 16b, which forms the lower half of the body 16. Figure 8A The probe hub 34 (shown in blue) and the outer casing hub 40 (shown in green) are shown in the ready-to-fire position. In this position, the probe hub impact portion 36 and the outer casing hub impact portion 42 are aligned with each other. When viewed from this position, in cross-section and relative to the upper casing 16a, Figure 10A The probe hub impact section 36 and the outer tube hub impact section 42 are shown positioned adjacent to each other, each engaging with corresponding catchers 30, 32 extending from the upper housing 16a on either side of the operating lever 18 to hold each impact section in a ready-to-fire position. In this position, the probe hub impact section 36 and the outer tube hub impact section 42 are positioned below the larger automatic button 14, wherein the operating lever 22 is positioned between the automatic button 14 and the probe hub impact section 36.

[0071] In use, when it is desired to fire the probe 106 without firing the outer sleeve 104, for example, to allow the fired probe 106 and the orifice of the probe 106 (e.g.) to be fired before firing the outer sleeve 104. Figure 13-17 When imaging at position 206, the smaller firing button 12 (delay button) is actuated / pressed to move the second operating lever 22, thereby applying pressure to the probe hub impact portion 36 using the protrusion 28 extending from the bottom surface of the operating lever 22. When the probe 106 is in the ready / unfired position, pushing the probe hub impact portion 36 downward / applying pressure to the probe hub impact portion 36 will cause the probe hub impact portion 36 to disengage from the capture member 30 and fire the probe 106. This process is as follows: Figure 11A As shown. When the probe hub impact section 36 is released / fired, the probe hub 34 moves in the distal direction. The movement of the probe hub 34 in the distal direction positions the proximal cantilever portion 38 of the probe hub 34 above the outer sleeve hub impact section 42, while being held by the capture member 32 (see...). Figure 8B and Figure 10B The second operating lever 22 is actuated to fire the probe 106, but not the outer tube 104. Therefore, the firing of the outer tube 104 is delayed using the button 12.

[0072] On the other hand, when the larger firing button (automatic button) 14 is actuated / pressed, both the first operating lever 18 and the second operating lever 22 move downwards. The proximal end 18a of the larger firing button 14 engages the second operating lever 22 by acting on the distal end 22a, thereby releasing the probe hub impact portion 36 from the capture member 30 and causing the inner probe 106 to fire. The probe hub 34 moves in the distal direction, thereby positioning the cantilever portion 38 of the probe hub 34 above the outer tube hub impact portion 42, as... Figures 9A-9B As shown. The larger firing button 14 acts directly on the second operating lever 22 to move it, thereby engaging and releasing the capture member 32. The capture member 32 holds the outer tube hub impact portion 42 in the ready-to-fire position. Since the bottom surface 14a of the first operating lever 18 is higher than the bottom surface 12a of the second operating lever 22, actuating / pressing the larger firing button 14 first acts on the second operating lever 22 and releases the probe hub impact portion 36, and then acts on the cantilever portion 38 of the operating lever 22 and the probe hub 34, which engages and releases the outer tube hub impact portion 42. When both the probe 106 and the outer tube 104 are in their respective ready-to-fire / unfired positions, the sequential release of the probe hub impact portion 36 and the outer tube hub impact portion 42 will sequentially fire the probe 106 and the outer tube 104. When probe 106 has been fired (e.g., by actuating / pressing the smaller firing button 12) and outer tube 104 is in the ready / unfired position, pressing the larger firing button 14 fires only outer tube 104.

[0073] Issuing Institution:

[0074] Various mechanisms and methods for preparing a biopsy device according to this disclosure are disclosed in U.S. Patent 9,585,639, the entire contents of which are incorporated herein by reference. In one exemplary embodiment, the biopsy device 10 is prepared by moving the preparation button 110 in a proximal direction (e.g., see [link to relevant documentation]). Figure 1A-1C ).

[0075] In one exemplary embodiment, the assembly for sequentially preparing the outer sheath 104 and the inner sheath or probe 106 includes a firing body 101 having a resilient shaft 100 and being operatively coupled to a user-operable firing button 110 (see [link to relevant documentation]). Figure 1A-1C and Figures 8A-8C The assembly also includes an outer tube hub 40 operably coupled to the outer tube 104. The outer tube hub 40 includes an outer tube impact portion 42 disposed along a first edge of the travel path of the shaft 100. Furthermore, the assembly includes a probe hub 34 operably coupled to the probe 106. The probe hub 34 includes a probe impact portion 36 disposed along a second opposite edge of the travel path of the shaft 100. When both the outer tube 104 and the probe 106 are in their respective firing / not-ready positions, the probe hub impact portion 36 is disposed adjacent to the outer tube impact portion 42 (see [link to documentation]). Figure 8C ).

[0076] The distal edge 42a of the outer tube hub impact portion 42 forms a wedge-shaped portion / ramp, with its high end adjacent to the first edge of the travel path of the shaft 100, and its low end away from the first edge. The distal edge 36a of the probe hub impact portion 36 forms a wedge-shaped portion / ramp, with its high end adjacent to the second edge of the travel path of the shaft 100 (adjacent to the second recess 122 in the shaft 100, as described below), and its low end away from the second edge. The distal edge 36a of the probe hub impact portion 36 is positioned flush with the distal edge 42a of the outer tube hub impact portion 42.

[0077] The proximal end 118 of shaft 100 expands to form a first capture member 32 and a second capture member 30, the first and second capture members being configured to receive the respective distal edges 42a, 36a of the outer casing hub impact portion 42 and the probe hub impact portion 36. The pre-launch process is typically performed in two steps: first, the pre-launch member 110 of the biopsy device 10 is pressed against the proximal end of the housing to compress the pre-launch member 110, while simultaneously moving the outer casing hub 40 and the outer casing hub impact portion 42 to engage the capture member 32 formed on the inner surface of the upper casing 16a. Subsequently, as the pre-launch member 110 moves towards the proximal end of the housing, it is compressed a second time, while simultaneously moving the movable probe hub 34 and the probe hub impact portion 36 to engage the capture member 30 formed on the inner surface of the upper casing 16a.

[0078] Tissue was removed from the biopsy device:

[0079] Spring-loaded core biopsy devices include, for example, a device 10 for removing tissue samples from a patient for pathological examination (e.g., determining the presence of cancer cells). A typical spring-loaded core biopsy device has a needle 202 in which an orifice 206 (e.g., a slot) is inserted, and the needle 202 is coaxially disposed within a cutting sleeve 204 having a sharp distal edge 208. During the biopsy, as the cutting sleeve 204 translates through the orifice 206, the cutting sleeve 204 cuts off the tissue prolapsed into the orifice 206, thereby forming a core of the excised tissue 210. The cutting sleeve 204 is then retracted, exposing the excised tissue 210 contained in the orifice 206. The tissue is then removed from the orifice 206 and placed in a fixative solution for analysis.

[0080] Several known methods exist for removing excised tissue 210 from orifice 206, including: scraping against the edge or interior of a collection container with a needle, grasping and depositing it into the collection container with forceps, shaking or tapping the needle to dislodge the excised tissue 210 into the collection container, or swabbing the tissue sample onto a piece of gauze and depositing it into the collection container. Known methods for removing excised tissue 210 from orifice 206 can be time-consuming, and the excised tissue 210 must be removed from orifice 206 before further tissue can be biopsied. Furthermore, all of the above-mentioned known methods carry the risk of dropping or otherwise contaminating the excised tissue core 210 during transfer to the collection container.

[0081] Figure 13-17 Various embodiments of removing excised tissue 210 from the orifice 206 of a spring-loaded core extractor 200 are shown, the device 200 may have components similar to those of the device 10 discussed above. Figure 13 An embodiment of a spring-loaded core-taking device 200 is shown, wherein the orifice 206 on the inner sleeve (i.e., needle or probe) 202 is coated with a lubricating material 212 to prevent tissue adhesion to the orifice 206. Adipose tissue is a typical tissue that adheres to the orifice 206 in the metal needle 202. Therefore, the lubricating material 212 coating can be oleophobic, hydrophobic, or a combination of both.

[0082] Figure 14 and Figure 15Another embodiment is shown, in which the spring-loaded core extraction device 200 includes a pushing device 214 configured to remove the core of the excised tissue 210 from an aperture 206 by mechanical pushing and / or scraping. The pushing device 214 includes a spoon-shaped, scraper-shaped, or other shaped body 216 disposed in the aperture 206 and its proximal end coupled to an elongated body 218 (e.g., a thin wire) extending along the length of the spring-loaded core extraction device 200 in an annular space 220 located between the needle 202 and the outer sheath 204. Figure 15 As shown, the elongated body 218 can be used to advance the spoon-shaped / scraper-shaped / shaping body 216 distally to expel / eject the core of the removed tissue 210 from the orifice 206. After expelling or ejecting the core of the removed tissue 210, the spoon-shaped / scraper-shaped / shaping body 216 can be retracted into the annular space 220. Alternatively, when not in use, the spoon-shaped / scraper-shaped / shaping body 216 can be positioned (substantially flush) against the proximal end of the orifice 206.

[0083] Figure 16 and Figure 17 Two related embodiments of a spring-loaded coring device 200 are shown, which uses a flushing fluid 222 (such as physiological saline) to flush the excised tissue core 210 from an orifice 206 into a collection bottle (not shown). Figure 16 In the illustrated embodiment, flushing fluid 222 is pushed distally through a spring-loaded core extractor 200 within the annular space 220 between the needle 202 and the outer cannula 204. A port (not shown) on the spring-loaded core extractor 200 can be attached to a syringe (not shown) filled with flushing fluid 222 to provide pressurized flushing fluid 222. Figure 17 In the illustrated embodiment, flushing fluid 222 is pushed distally through the spring-loaded core extractor 200 within the cavity 224 of the hollow needle 202. This embodiment allows the flushing fluid 222 to flow more directly into the orifice 206 to flush out the excised tissue core 210 from the orifice.

[0084] Example

[0085] Examples of biopsy devices are provided below. Embodiments of the biopsy devices described herein may include any one or more of the following terms, and any combination thereof:

[0086] Clause 1. A biopsy device, the biopsy device comprising:

[0087] An elongated shell having a proximal end and a distal end;

[0088] A probe hub slidably mounted in the housing, wherein the probe hub is movable relative to the housing between a proximal ready position and a distal firing position, the probe hub having a probe hub impact portion configured to hold the probe hub in its proximal ready position;

[0089] A sleeve hub, slidably mounted in the housing, wherein the sleeve hub is movable relative to the housing between a proximal ready position and a distal firing position, the sleeve hub having a sleeve hub impact portion configured to hold the sleeve hub in its proximal ready position; and

[0090] A firing member, which is movably mounted to the housing and configured such that the probe hub and the sleeve hub are moved to their respective proximal firing positions;

[0091] The housing includes a first deflectable wall portion located proximal to the distal end of the housing, and

[0092] When the probe hub is in the distal firing position and the sleeve hub is in the proximal ready position, a portion of the probe hub is positioned between the sleeve impact portion and the first deflectable wall portion, thereby enabling the first deflectable wall portion to actuate the sleeve hub to release the sleeve hub from its proximal ready position and advance the sleeve hub in the distal direction.

[0093] Clause 2. The biopsy device according to Clause 1, wherein the housing further includes a second deflectable wall portion located proximal to the proximal end of the housing, the free end of the first deflectable wall portion extending over the free end of the second deflectable wall portion.

[0094] Clause 3. The biopsy apparatus according to Clause 2, wherein, when the probe hub and the cannula hub are in their proximal ready positions, actuation of either the first deflectable wall portion or the second deflectable wall portion releases the probe hub from its proximal ready position to advance the probe hub in a distal direction.

[0095] Clause 4. The biopsy apparatus according to Clause 1, wherein the portion of the probe hub positioned between the sleeve impact portion and the first deflectable wall portion is the cantilever portion of the probe hub.

[0096] Clause 5. A biopsy apparatus according to any one of Clauses 1-4, wherein the actuator of the first deflectable wall portion has a recessed surface.

[0097] Clause 6. A biopsy apparatus according to any one of Clauses 2-5, wherein the actuator of the second deflectable wall portion has an inclined surface.

[0098] Clause 7. The biopsy apparatus according to Clause 6, wherein the inclined surface includes an imprint symbol.

[0099] Clause 8. A biopsy apparatus according to any one of Clauses 1-7, wherein the pre-detonation member is spring-biased and configured to be manually actuated from a relaxed extended position to a loaded compressed position.

[0100] Clause 9. The biopsy apparatus according to Clause 8, wherein the test component is positioned proximal to the probe hub and the cannula hub.

[0101] Clause 10. A biopsy apparatus according to any one of Clauses 1-9, wherein the cannula hub and the probe hub are positioned side by side with each other and movable relative to each other within the housing, and wherein the cannula hub and the probe hub are further configured to align when the cannula hub and the probe hub are in their respective distal firing positions.

[0102] Clause 11. A biopsy device according to any one of Clauses 2-10, wherein the first deflectable wall portion includes a first actuator and a first protrusion, and the second deflectable wall portion includes a first segment, a second segment, and a second actuator, the second segment having a second protrusion extending into the housing.

[0103] Clause 12. The biopsy apparatus according to Clause 11, wherein when the first actuator is actuated to advance the probe hub to its distal firing position, the first actuator contacts and deflects the second section of the second deflectable wall portion such that the second protrusion engages with the probe hub impact portion.

[0104] Clause 13. The biopsy device according to Clause 12, wherein the second section of the second deflectable wall portion has a tapered end and is spaced apart from the first protrusion of the first deflectable wall portion.

[0105] Clause 14. The biopsy apparatus according to Clause 2, wherein the first actuator is integrally formed with the first deflectable wall portion, and the second actuator is integrally formed with the second deflectable wall portion.

[0106] Clause 15. The biopsy device according to Clause 14, wherein the first actuator is a first button and the second actuator is a second button.

[0107] Clause 16. The biopsy device according to Clause 15, wherein the first button is larger than the second button.

[0108] Clause 17. The biopsy device according to Clause 15, wherein the first button has a recessed surface.

[0109] Clause 18. The biopsy device according to Clause 17, wherein the first button includes a distal edge with a raised edge.

[0110] Clause 19. A biopsy apparatus according to any one of Clauses 1-18, wherein the firing member is configured to retract the probe hub and / or the cannula hub until the internal structure of the housing engages with the corresponding impact portion of the probe hub or the cannula hub.

[0111] Clause 20. A biopsy apparatus according to any one of Clauses 1-19, wherein each of the probe hub and the cannula hub is in a compressed state when in the proximal ready position.

[0112] Clause 21. A biopsy apparatus according to any one of Clauses 1-20, wherein the thickness and / or height of the probe hub impact portion is greater than the thickness and / or height of the sleeve hub impact portion.

[0113] Clause 22. A biopsy device, the biopsy device comprising:

[0114] A slender shell;

[0115] A probe hub, slidably mounted in the housing, wherein the probe hub is movable relative to the housing between a proximal ready position and a distal firing position, the probe hub having a probe impact portion;

[0116] A cannula hub, slidably mounted within the housing and side-by-side with the probe hub, wherein the cannula hub is movable relative to the housing between a proximal ready-to-fire position and a distal firing position, and the cannula hub has a cannula impact portion; and

[0117] A spring-biased firing member, which is movably mounted on the housing, near the respective probe hub and sleeve hub;

[0118] The probe impact portion and the sleeve impact portion are aligned when in the proximal ready-to-fire position, and when in the proximal ready-to-fire position, the probe impact portion and the sleeve impact portion are positioned below the actuable portion of the housing.

[0119] Clause 23. The biopsy device according to Clause 22, wherein the housing is composed of an upper housing portion and a lower housing portion, and the actuable portion of the housing includes an operating lever integrally formed in the upper housing portion.

[0120] Clause 24. The biopsy apparatus according to Clause 22, wherein, when the probe hub is in the distal firing position and the cannula hub is in the proximal firing position, a portion of the probe hub is positioned between the cannula impact portion and the actuable portion of the housing.

[0121] Clause 25. The biopsy apparatus according to Clause 22, wherein the biopsy apparatus is configured to prevent the cannula hub from firing until the probe hub has moved to the distal firing position.

[0122] This disclosure describes some examples of the present technology with reference to the accompanying drawings, in which some possible examples are shown. However, other aspects may be embodied in many different forms and should not be construed as being limited to the examples set forth herein. Rather, these examples are provided so that this disclosure is thorough and complete and fully conveys to those skilled in the art the scope of possible examples.

[0123] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modified by the term "approximately". The term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(i.e., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant value.

[0124] The range of numbers described by the endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0125] This specification and accompanying drawings, which illustrate exemplary embodiments, should not be considered limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this specification and the claims (including equivalents). In some cases, the fact that well-known structures and techniques are not shown or described in detail does not make this disclosure difficult to understand. Furthermore, elements and related features described in detail with reference to one embodiment may be included in other embodiments, even if they are not specifically shown or described, provided it is practicable. For example, if an element is described in detail with reference to one embodiment but not with reference to a second embodiment, that element may still be included in the second embodiment.

[0126] It is worth noting that, as used herein, the singular forms of “a,” “one,” and “the,” as well as any singular use of any word, include multiple referents unless explicitly and unambiguously limited to a single referent. As used herein, the term “including” and its grammatical variations are intended to be non-restrictive, such that the items listed do not exclude other similar items that may be substituted for or added to the listed items.

[0127] Furthermore, the terminology used in this description is not intended to limit this disclosure. For example, spatially relative terms (such as “below,” “under,” “down,” “above,” “up,” “forward,” “front,” “back,” etc.) may be used to describe the relationship of one element or feature to another element or feature as shown in the orientations of the figures. In addition to the positions and orientations shown in the figures, these spatially relative terms are intended to cover different positions and orientations of the device in use or operation. For example, if the device in the figures is inverted, an element described as being “below” or “under” other elements or features would be “above” or “on” other elements or features. Thus, the exemplary term “below” can cover both above and below positions and orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations) and the spatially relative descriptions used herein should also be interpreted accordingly.

[0128] Given the disclosure herein, further modifications and alternative embodiments will be apparent to those skilled in the art. For example, the system may include additional components omitted from the drawings and description for clarity of operation. Therefore, this description is to be interpreted as illustrative only, and its purpose is to teach those skilled in the art the general manner in which to implement the systems and methods of this disclosure. It should be understood that the various embodiments shown and described herein should be considered exemplary embodiments. Elements and materials, and arrangements of such elements and materials, may be substituted for those shown and described herein, parts and processes may be reversed, and certain features of this teaching may be utilized independently, all of which will be apparent to those skilled in the art upon benefiting from the description herein. Changes may be made to the elements described herein without departing from the scope of this disclosure.

[0129] It should be understood that the specific examples and embodiments set forth herein are non-limiting, and modifications to the structure, dimensions, materials, and methods may be made without departing from the scope of this disclosure. Other embodiments of the invention disclosed herein will be apparent to those skilled in the art upon consideration of the description and practice of the invention. It is contemplated that the descriptions and examples are intended to be considered merely exemplary and are entitled to enjoy their full scope, including equivalents.

Claims

1. A biopsy device, the biopsy device comprising: A slender shell having a proximal end and a distal end; A probe hub slidably mounted in the housing, wherein the probe hub is movable relative to the housing between a proximal ready position and a distal firing position, the probe hub having a probe hub impact portion configured to hold the probe hub in its proximal ready position; A sleeve hub, slidably mounted in the housing, wherein the sleeve hub is movable relative to the housing between a proximal ready position and a distal firing position, the sleeve hub having a sleeve hub impact portion configured to hold the sleeve hub in its proximal ready position; and A firing member, which is movably mounted to the housing and configured such that the probe hub and the sleeve hub are moved to their respective proximal firing positions; The housing includes a first deflectable wall portion located on the proximal side of the distal end of the housing, and When the probe hub is in the distal firing position and the sleeve hub is in the proximal ready position, a portion of the probe hub is positioned between the sleeve impact portion and the first deflectable wall portion, thereby enabling the first deflectable wall portion to actuate the sleeve hub to release the sleeve hub from its proximal ready position and advance the sleeve hub in the distal direction.

2. The biopsy device according to claim 1, wherein, The housing also includes a second deflectable wall portion located near the proximal end of the housing, with the free end of the first deflectable wall portion extending over the free end of the second deflectable wall portion.

3. The biopsy device according to claim 2, wherein, When the probe hub and the sleeve hub are in their proximal ready positions, actuation of either the first deflectable wall portion or the second deflectable wall portion releases the probe hub from its proximal ready position to advance the probe hub in a distal direction.

4. The biopsy device according to claim 1, wherein, The portion of the probe hub positioned between the sleeve impact section and the first deflectable wall section is the cantilever portion of the probe hub.

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

6. The biopsy device according to any one of claims 2-5, wherein, The actuator of the second deflectable wall portion has an inclined surface.

7. The biopsy device according to claim 6, wherein, The inclined surface includes embossed symbols.

8. The biopsy device according to any one of claims 1-7, wherein, The component to be launched is spring-biased and configured to be manually actuated from a relaxed extended position to a loaded compressed position.

9. The biopsy device according to claim 8, wherein, The component to be launched is positioned near the probe hub and the sleeve hub.

10. The biopsy device according to any one of claims 1-9, wherein, The sleeve hub and the probe hub are positioned side by side and movable relative to each other within the housing, wherein the sleeve hub and the probe hub are also configured to align when the sleeve hub and the probe hub are in their respective distal firing positions.

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

12. The biopsy device according to claim 11, wherein, When the first actuator is actuated to advance the probe hub to its distal firing position, the first actuator contacts the second section of the second deflectable wall portion and deflects the second section, such that the second protrusion engages with the probe hub impact portion.

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

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

15. The biopsy apparatus according to claim 14, wherein, The first actuator is a first button, and the second actuator is a second button.

16. The biopsy apparatus according to claim 15, wherein, The first button is larger than the second button.

17. The biopsy apparatus according to claim 15, wherein, The first button has a recessed surface.

18. The biopsy device according to claim 17, wherein, The first button includes a distal edge with a raised edge.

19. The biopsy apparatus according to any one of claims 1-18, wherein, The firing member is configured to retract the probe hub and / or the sleeve hub until the internal structure of the housing engages with the corresponding impact portion of the probe hub or the sleeve hub.

20. The biopsy device according to any one of claims 1-19, wherein, Each of the probe hub and the sleeve hub is in a compressed state when it is in the proximal ready position.

21. The biopsy apparatus according to any one of claims 1-20, wherein, The thickness and / or height of the probe hub impact portion is greater than the thickness and / or height of the sleeve hub impact portion.

22. A biopsy device, the biopsy device comprising: A slender shell; A probe hub, slidably mounted in the housing, wherein the probe hub is movable relative to the housing between a proximal ready position and a distal firing position, the probe hub having a probe impact portion; A cannula hub, slidably mounted within the housing and side-by-side with the probe hub, wherein the cannula hub is movable relative to the housing between a proximal ready position and a distal firing position, and the cannula hub has a cannula impact portion; and A spring-biased firing member, which is movably mounted on the housing, near the respective probe hub and sleeve hub; The probe impact portion and the sleeve impact portion are aligned when they are in the proximal ready-to-fire position, and when they are in the proximal ready-to-fire position, the probe impact portion and the sleeve impact portion are positioned below the actuable portion of the housing.

23. The biopsy device according to claim 22, wherein, The housing is composed of an upper housing portion and a lower housing portion, and the actuable portion of the housing includes an operating lever integrally formed in the upper housing portion.

24. The biopsy apparatus according to claim 22, wherein, When the probe hub is in the distal firing position and the sleeve hub is in the proximal ready-to-fire position, a portion of the probe hub is positioned between the sleeve impact portion and the actuable portion of the housing.

25. The biopsy device according to claim 22, wherein, The biopsy device is configured to prevent the cannula hub from firing until the probe hub has moved to the distal firing position.

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