Multi-sample core needle biopsy device with limited lancet firing

Abstract

The core needle biopsy device includes a needle assembly, a cutter drive assembly, a lancing device drive assembly, and a latch mechanism. The needle assembly includes a lancing device and a hollow cutter. The lancing device includes a sharp distal tip and a notch proximal to the distal tip. The lancing device is slidably disposed within the cutter to sever a tissue sample into the notch of the lancing device. The cutter drive assembly is configured to move the cutter. The lancing device drive assembly is configured to move the lancing device. The lancing device drive assembly includes a lead screw. The lead screw is configured to move both a portion of the cutter drive assembly and a portion of the lancing device drive assembly. The latch mechanism is configured to selectively couple a portion of the cutter drive assembly to a portion of the lancing device drive assembly.

Description

[Technical Field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 63 / 435,615, entitled "Multi-Sample Core Needle Biopsy Device Having Limited Piercer Firing," filed December 28, 2022, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] A biopsy is the removal of a tissue sample from a patient so that the tissue can be examined for signs of cancer or other disorders. Tissue samples can be obtained in a variety of ways using a variety of medical procedures involving a variety of sample collection devices. For example, a biopsy can be an open procedure (surgical removal of tissue after making an incision) or a percutaneous procedure (e.g., by fine needle aspiration, core needle biopsy, or vacuum biopsy). After the tissue sample is collected, it is generally analyzed in a laboratory (e.g., a pathology laboratory, a biomedical laboratory, etc.) set up to perform the appropriate tests (e.g., histological analysis).

[0003] One technique for collecting breast biopsies involves the use of a core needle biopsy device. One such device is the MAX-CORE disposable core biopsy instrument manufactured by Bard Biopsy Systems. Core needle biopsy devices often use a sharp, solid lancing tool with a lateral tissue-receiving notch located adjacent the distal end of the lancing tool. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severing tissue sample is then stored within the notch until both the lancing tool and the cutting sheath are removed from the patient. Thus, core needle biopsy devices can collect only one tissue sample per insertion of the lancing tool and cutting sheath.

[0004] In contrast to core needle breast biopsy procedures, vacuum-assisted breast biopsy devices allow for the extraction of multiple samples with a needle without the need to remove the needle from the breast after each sample collection. For example, vacuum-assisted breast biopsy devices use a hollow needle to penetrate tissue. The hollow needle may include a lateral opening adjacent to a sharp distal tip. A hollow cutter may be disposed within the hollow needle, and the hollow cutter may be moved axially relative to the lateral opening of the needle to sever the tissue sample. Once the tissue sample is severed by the hollow cutter, it is transported axially within the cutter and collected in a tissue collection feature.

[0005] Examples of suction biopsy devices and biopsy system components are described in U.S. Pat. No. 5,526,822, issued June 18, 1996, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," U.S. Pat. No. 6,086,544, issued July 11, 2000, entitled "Control Apparatus for an Automated Surgical Biopsy Device," U.S. Pat. No. 6,162,187, issued December 19, 2000, entitled "Fluid Collection Apparatus for a Surgical Device," U.S. Pat. No. 6,432,065, issued August 13, 2002, entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Pat. No. 6,432,065, issued June 22, 2004, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," and U.S. Pat. No. 6,432,065, issued June 22, 2004, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode." U.S. Patent No. 6,752,768 entitled "Remote Thumbwheel for a Surgical Biopsy Device," issued on October 8, 2008; U.S. Patent No. 7,442,171 entitled "Remote Thumbwheel for a Surgical Biopsy Device," issued on December 1, 2010; U.S. Patent No. 7,854,706 entitled "Clutch and Valving System for Tetherless Biopsy Device," issued on March 29, 2011; U.S. Patent No. 7,914,464 entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," issued on May 10, 2011; U.S. Patent No. 7,938,193 entitled "Vacuum Timing Algorithm for Biopsy Device," issued on May 10, 2011;No. 786, issued on December 21, 2011, entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder," U.S. Patent No. 8,083,687, issued on February 1, 2012, entitled "Biopsy Sample Storage," U.S. Patent No. 8,118,755, issued on February 1, 2012, entitled "Tetherless Biopsy Device with Reusable Portion," U.S. Patent No. 8,206,316, issued on June 26, 2012, entitled "Biopsy Device with Discrete Tissue Chambers," U.S. Patent No. 8,702,623, issued on April 22, 2014, entitled "Biopsy Device with Motorized Needle Firing," U.S. Patent No. 8,858,465, issued on October 14, 2014, entitled "Biopsy Device with Motorized Needle Firing," and U.S. Patent No. 8,858,465, issued on May 3, 2016, entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and No. 9,326,755, entitled "Pathology Chamber," the disclosures of each of the above-listed U.S. patents are incorporated herein by reference.

[0006] Additional examples of suction biopsy devices and biopsy system components are described in U.S. Publication No. 2006 / 0074345, published April 6, 2006, now abandoned, entitled "Biopsy Apparatus and Method," U.S. Publication No. 2009 / 0131821, published May 21, 2009, now abandoned, entitled "Graphical User Interface for Biopsy System Control Module," U.S. Publication No. 2010 / 0152610, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol Grip," U.S. Publication No. 2010 / 0160819, published June 24, 2010, now abandoned, entitled "Biopsy Device with Central Thumbwheel," and U.S. Publication No. 2010 / 0160819, published December 5, 2013, now abandoned, entitled "Control for Biopsy System Control Module." and U.S. Publication No. 2013 / 0324882, entitled "Method and Apparatus for Promoting a Novel Electrode-Based Imaging Device." The disclosures of each of the above U.S. patent application publications are incorporated herein by reference.

[0007] Examples of core needle biopsy devices are disclosed in U.S. Patent No. 5,560,373, entitled "Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly," issued October 1, 1996; U.S. Patent No. 5,817,033, entitled "Needle Core Biopsy Device," issued October 6, 1998; U.S. Patent No. 5,971,939, entitled "Needle Core Biopsy Device," issued October 26, 1999; and U.S. Patent No. 5,511,556, entitled "Needle Core Biopsy Instrument," issued April 30, 1996. The disclosures of each of the above U.S. patents are incorporated herein by reference.

[0008] Examples of other forms of biopsy devices are disclosed in U.S. Publication No. 2021 / 0153850, entitled "Tissue Collection Device for Collection of Tissue Samples from a Biopsy Needle and a Biopsy Device Including Tissue Collection Device," published May 27, 2021; U.S. Patent No. 8,485,989, entitled "Biopsy Apparatus Having a Tissue Sample Retrieval Mechanism," published June 16, 2013; and U.S. Patent No. 11,013,499, entitled "Core Needle Biopsy Device," published May 25, 2021, the disclosures of which are incorporated herein by reference.

[0009] In some situations, it may be desirable to combine the features of core needle biopsy devices and suction biopsy devices to obtain the benefits of both devices and mitigate their overall drawbacks. For example, core needle biopsy devices may be advantageous due to their simplicity, lightness, and ease of use. Furthermore, core needle biopsy devices generally include smaller needle sizes, which may be desirable to enhance patient comfort and recovery time. On the other hand, suction biopsy devices may be advantageous due to their ability to collect multiple samples with a single insertion. Therefore, a simple, lightweight biopsy device capable of collecting multiple samples with a single insertion may be desirable.

[0010] One challenge in using biopsy devices generally may involve collecting one or more tissue samples from areas near particularly sensitive tissue. For example, in the context of breast biopsy, collecting one or more tissue samples from areas near the axilla or chest wall may present this challenge. In situations such as these, it may be desirable to avoid contact between one or more parts of the biopsy device and the sensitive anatomical structure while getting close enough to the sensitive anatomical structure to access the area of ​​interest. This desirability may be complicated by the fact that, in the context of core needle biopsy, elements of the biopsy device may be configured to fire cutters, lancets, and the like. Therefore, in some situations, it may be desirable to limit or modify the firing elements of the biopsy device.

[0011] Although several systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the present invention made or used the invention as set forth in the appended claims.

[0012] While the specification concludes with claims particularly pointing out and distinctly claiming the invention, the invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which some components or portions of components are shown in phantom, as indicated by dashed lines. [Brief explanation of the drawings]

[0013] [Figure 1] 1 shows a perspective view of a version of a core needle biopsy device. [Figure 2] 2 shows a perspective view of the needle assembly of the core needle biopsy device of FIG. 1. [Figure 3] 3 shows a side view of the needle assembly of FIG. 2, with the needle assembly in proximity to a lesion. [Figure 4] 3 shows another side view of the needle assembly of FIG. 2 with the piercer of the needle assembly penetrating the lesion of FIG. 3. [Figure 5]3 shows yet another side view of the needle assembly of FIG. 2, with the cutter of the needle assembly penetrating the lesion of FIG. 3 to sever a tissue sample. [Figure 6] 4 shows a perspective view of the biopsy device of FIG. 1, with the lancet of FIG. 4 retracted relative to the cutter of FIG. 5; [Figure 7] 2 shows a perspective view of a drive assembly that can be readily incorporated into the core needle biopsy device of FIG. 1; [Figure 8A] FIG. 8 shows a perspective view of the lancing device drive assembly of the drive assembly of FIG. 7. [Figure 8B] 8B shows a detailed perspective view of the lancing device lead screw and the cutter lead screw of the lancing device drive assembly of FIG. 8A. [Figure 9] 8B shows an exploded perspective view of the latch mechanism of the lancing device drive assembly of FIG. 8A. [Figure 10] FIG. 10 shows a front view of the cam member of the latch mechanism of FIG. 9. [Figure 11] 11 shows a rear view of the cam member of FIG. 10. [Figure 12] FIG. 8 shows an exploded perspective view of the cutter drive assembly of the drive assembly of FIG. 7. [Figure 13] FIG. 8 shows a perspective view of the control shaft of the drive assembly of FIG. 7. [Figure 14] 8 illustrates a perspective cutaway view of the drive assembly of FIG. 7 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in an initial configuration. [Figure 15] 13 shows a perspective view of the latch mechanism of FIG. 9 coupled to the cutter drive assembly of FIG. 12. [Figure 16] 8 illustrates another perspective cutaway view of the drive assembly of FIG. 7 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in an unlocked configuration. [Figure 17A] 17 illustrates a cross-sectional view of the latch mechanism of FIG. 9, the cross-section being taken along line 17-17 of FIG. 16, with the latch mechanism in the latched configuration. [Figure 17B] 17 illustrates another cross-sectional view of the latch mechanism of FIG. 9, the cross-section being taken along line 17-17 of FIG. 16, with the latch mechanism in an unlatched configuration. [Figure 18A]17 shows a cross-sectional view of the latch mechanism of FIG. 9, the cross-section being taken along a line perpendicular to line 17-17 of FIG. 16, with the latch mechanism in the latched configuration. [Figure 18B] 17 shows another cross-sectional view of the latch mechanism of FIG. 9, the cross-section being taken along a line perpendicular to line 17-17 of FIG. 16, with the latch mechanism in an intermediate configuration. [Figure 18C] 17 illustrates yet another cross-sectional view of the latch mechanism of FIG. 9, the cross-section being taken along a line perpendicular to line 17-17 of FIG. 16, with the latch mechanism in an unlatched configuration. [Figure 19] 8 illustrates yet another perspective cutaway view of the drive assembly of FIG. 7 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in a firing configuration. [Figure 20] 1. FIG. 4 shows a perspective view of another drive assembly that can be readily incorporated into the core needle biopsy device of FIG. [Figure 21] 21 shows an exploded perspective view of the lancing device drive assembly of the drive assembly of FIG. 20. [Figure 22] 22 shows a perspective cross-sectional view of the lead screw shaft of the lancing device drive assembly of FIG. 21, the cross-section being taken along the longitudinal axis of the lead screw shaft. [Figure 23] 22 shows a perspective view of the lancing device carriage of the lancing device drive assembly of FIG. 21. [Figure 24] 22 shows an exploded perspective view of the latch mechanism of the lancing device drive assembly of FIG. 21. [Figure 25] FIG. 25 shows a front view of the cam member of the latch mechanism of FIG. 24. [Figure 26] 26 shows a rear view of the cam member of FIG. 25. [Figure 27] FIG. 21 shows an exploded perspective view of the cutter drive assembly of the drive assembly of FIG. 20; [Figure 28] FIG. 28 shows a perspective view of the cutter carriage of the cutter drive assembly of FIG. 27; [Figure 29] 29 shows a partial top view of the cutter carriage of FIG. 28. [Figure 30] FIG. 21 shows a perspective view of the control shaft of the drive assembly of FIG. 20. [Figure 31]21 shows a perspective cutaway view of the drive assembly of FIG. 20 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in an initial configuration. [Figure 32] 28 shows a perspective view of the latch mechanism of FIG. 24 coupled to the cutter drive assembly of FIG. 27. FIG. [Figure 33] 29 shows a perspective view of the lancing device of the core needle biopsy device of FIG. 1 positioned within a portion of the cutter carriage of FIG. 28. [Figure 34] 21 shows another perspective cutaway view of the drive assembly of FIG. 20 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in the armed configuration; [Figure 35] 35 shows a side cross-sectional view of the drive assembly of FIG. 20, the cross-section being taken along line 35-35 of FIG. 34, with the drive assembly in a near stop configuration. [Figure 36] 36 shows a perspective view of the needle assembly of FIG. 2, with the needle assembly in a short stop configuration corresponding to the short stop configuration of FIG. 35; [Figure 37] 34 shows another cross-sectional side view of the drive assembly of FIG. 20, the cross-section being taken along the longitudinal axis of the drive assembly, with the drive assembly in the armed configuration of FIG. [Figure 38] 35 shows another perspective view of the needle assembly of FIG. 2, with the needle assembly in an armed configuration corresponding to the armed configuration of FIG. 34; [Figure 39A] 39 illustrates a cross-sectional view of the latch mechanism of FIG. 24, the cross-section being taken along line 39-39 of FIG. 34, with the latch mechanism in the latched configuration. [Figure 39B] 39 illustrates another cross-sectional view of the latch mechanism of FIG. 24, the cross-section being taken along line 39-39 of FIG. 34, with the latch mechanism in an intermediate configuration. [Figure 40A] 39 shows a cross-sectional view of the latch mechanism of FIG. 24, the cross-section being taken along a line perpendicular to line 39-39 of FIG. 34, with the latch mechanism in the latched configuration. [Figure 40B] 39 illustrates another cross-sectional view of the latch mechanism of FIG. 24, the cross-section being taken along a line perpendicular to line 39-39 of FIG. 34, with the latch mechanism in an unlatched configuration. [Figure 41]21 illustrates yet another perspective cutaway view of the drive assembly of FIG. 20 incorporated into the core needle biopsy device of FIG. 1, the drive assembly in a firing configuration. [Figure 42] FIG. 29 illustrates a cross-sectional view of the cutter carriage of FIG. 28, the cross-section being taken along a line perpendicular to the longitudinal axis of the cutter carriage, with the cutter carriage transitioning from the armed configuration to the fired configuration. [Figure 43] 42 shows yet another perspective view of the needle assembly of FIG. 2, the needle assembly in a firing configuration corresponding to the firing configuration of FIG. 41; DETAILED DESCRIPTION OF THE INVENTION

[0014] The drawings are not intended to be limiting in any way, and it is envisioned that various embodiments of the invention may be practiced in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise configurations shown.

[0015] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the invention. As will be understood, the present invention is capable of other different and obvious aspects, all without departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0016] Biopsy devices may be utilized to collect tissue samples in a variety of ways. For example, in some cases, tissue samples are collected in a single tissue basket, such that all tissue samples collected during a given biopsy procedure are accumulated in the single tissue sample basket. In some other instances, tissue samples are collected in a tissue sample holder having a separate compartment for each collected tissue sample. Such multi-compartment tissue sample holders may further include trays or strips that hold each tissue sample separately from the other tissue samples. Such trays or strips may be removable or otherwise separable from the tissue sample holder upon completion of the biopsy procedure.

[0017] Regardless of the structure in which the tissue sample is stored, the tissue sample may be collected using a biopsy device under the guidance of various imaging modalities, such as ultrasound imaging guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, breast-specific gamma imaging ("BSGI") guidance, etc. Each procedure has its own methodology based on the form of imaging guidance used.

[0018] Both suction biopsy devices and core needle biopsy devices may have various advantages over the other, depending on the situation. For example, one advantage of suction biopsy devices is that suction allows for the extraction of multiple tissue samples with a single insertion. On the other hand, core needle biopsy devices lack this feature, but their use may nevertheless be desirable in some situations. For example, core needle biopsy devices may generally include smaller needles than suction biopsy devices, thereby reducing patient anxiety and increasing the needle's ability to penetrate a lesion. Therefore, in some cases, it may be desirable to incorporate the multiple sample extraction feature of a suction biopsy device into a core needle biopsy device in order to obtain the benefits found in both styles of biopsy devices.

[0019] A desirable feature of the devices described herein is that they are core needle biopsy devices that allow for the acquisition of multiple samples with a single insertion while still using the elements of a core needle biopsy device. To facilitate this function, the biopsy device further includes a drive mechanism for firing elements associated with the needle assembly, such as a lancing device and / or a cutter. In some aspects, such a drive mechanism can be configured to limit the firing capability of one or more elements of the needle to facilitate performing biopsy procedures in proximity to sensitive patient anatomical structures.

[0020] I. Example of a Core Needle Biopsy Device with Multiple Sample Collection FIG. 1 illustrates a version of a core needle biopsy device 10 for use in a breast biopsy procedure. This version of the core needle biopsy device 10 includes a body 12 and a needle assembly 20 extending distally from the body 12. The body 12 includes an outer housing 14 and an actuation member 16 disposed on the outer housing 14. As described in further detail below, the outer housing 14 encases various components of the biopsy device 10, which are used to drive the needle assembly 20 through cutting and tissue-grabbing cycles. To this end, this version of the outer housing 14 is sized and shaped to be grasped by an operator in one hand. While not shown, it should be understood that in some versions, the outer housing 14 may include multiple sections interconnected to form the outer housing 14.

[0021] FIG. 2 shows needle assembly 20 in more detail. As can be seen, needle assembly 20 includes an elongated piercer 22 and an elongated cutter 40. As described in further detail below, piercer 22 is generally movable relative to cutter 40 to pierce tissue and collect a tissue sample, while cutter 40 is generally movable relative to piercer 22 to sever the tissue sample. Piercer 22 includes a generally cylindrical rod 28 (also referred to as a shaft) having a sharpened distal tip 24 and a notch 26 disposed adjacent distal tip 24. As described in further detail below, distal tip 24 is generally configured to penetrate a patient's tissue. Additionally, notch (26) is generally configured to receive tissue therein so that the tissue sample may be collected within notch (26) after it has been cut by cutter (40), as will be described in more detail below.

[0022] Cutter (40) includes a generally hollow cylindrical tube configured to receive lancer (22) therein. Cutter (40) includes an open distal end (42) and a cannula portion (44). Open distal end (42) is configured to allow at least a portion of lancer (22) to protrude from cutter (40) when lancer (22) is moved relative to cutter (40). In some versions, such as the illustrated version, open distal end (42) may also be oriented at an angle relative to the longitudinal axis of cutter (40). In other versions, open distal end (42) may alternatively be perpendicular to the longitudinal axis of cutter (40). As described in more detail below, this configuration allows needle assembly (20) to move through cutting and tissue collection cycles by allowing notch (26) of lancer (22) to move relative to distal end (42) of cutter (40).

[0023] The open distal end (42) of this version includes a tapered edge (43). The tapered edge (43) is generally configured to bite into tissue and separate the tissue sample when the cutter (40) is moved relative to the notch (26) of the lancing device (22). It should be understood, therefore, that the tapered edge (43) is generally configured to function as a blade. While this version is described and illustrated as using a tapered configuration, it should be understood that in other versions, various alternative configurations may be used. For example, in some versions, the tapered edge (43) includes multiple serrated edges in addition to or instead of the illustrated taper. In still other versions, the tapered edge (43) may include any other additional or alternative cutting surface, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0024] A cannula portion (44) of cutter (40) extends proximally from distal end (42) into body (12) so that lancer (22) can be received at the proximal end of cutter (40). In some versions, cannula portion (44) may be secured to an end, cutter carriage, or other feature used to facilitate operation of cutter (40). In such versions, a feature such as an end may be generally elongated to accommodate additional features, such as a tissue collection feature. Suitable tissue collection features may be configured according to one or more of the teachings of U.S. Patent Application No. 63 / 316,184, filed March 3, 2022, entitled "Sample Management for Core Needle Biopsy Device," the disclosure of which is incorporated herein by reference in its entirety.

[0025] FIG. 2 shows a puncture device (22) disposed within a cutter (40). As shown, the cutter (40) is generally configured to receive the puncture device (22) such that the puncture device (22) is coaxial with the cutter (40). Additionally, the puncture device (22) is generally movable relative to the open distal end (42) of the cutter (40). It should be understood that in some situations, the puncture device (22) moves relative to the cutter (40) while the cutter (40) remains stationary. In other situations, the cutter (40) moves relative to the puncture device (22) while the puncture device (22) remains stationary. In either case, it should be understood that the lancet 22 and cutter 40 are generally configured such that the notch 26 of the lancet 22 can be moved into and out of the cutter 40, thereby positioning the notch 26 distally or proximally relative to the open distal end 42 of the cutter 40. As described in further detail below, this configuration allows the lancet 22 and cutter 40 to operate in concert to penetrate tissue, sever a tissue sample, and withdraw the tissue sample for collection by an operator via one or more tissue collection features.

[0026] As seen in FIG. 2 , the cutter (40) and lancing device (22) may be in communication with the tissue collection assembly (80) and drive assemblies (200, 400). As described in more detail below, the tissue collection assembly (80) and a given drive assembly (200, 400) may be configured to operate cooperatively with the cutter (40) and lancing device (22) to collect multiple tissue samples within a portion of the tissue collection assembly (80) during a single insertion. For example, a given drive assembly (200, 400) may be configured to move the cutter (40) and lancing device (22) in a predetermined sequence to sever tissue samples. A given drive assembly (200, 400) may then retract the lancing device (22) relative to the body (12) for operation to move the tissue sample severed by the sampling assembly (80) out of the notch (26) of the lancing device (22) and into an area of ​​the sampling assembly (80) configured for storage of the tissue sample. In some versions, the tissue sampling assembly (80) may be configured according to one or more of the teachings of U.S. Patent Application No. 63 / 316,184, filed March 3, 2022, entitled "Sample Management for Core Needle Biopsy Device," the disclosure of which is incorporated herein by reference in its entirety. Various aspects of the drive assembly (200, 400) are described in more detail below, but it should be understood that in some versions, the drive assembly (200, 400) may be configured in accordance with one or more of the teachings of U.S. Publication No. 2022 / 0249075, entitled "Core Needle Biopsy Device for Collecting Multiple Samples in a Single Insertion," published August 11, 2022, the disclosure of which is incorporated by reference in its entirety into this specification.

[0027] 3-5 illustrate an exemplary process for collecting a tissue sample using a needle assembly (20). As seen in FIG. 3, the needle assembly (20) may first be positioned proximate a lesion (LE) or other area of ​​interest. At this stage, the cutter (40) may be positioned relative to the lancet (22) so that the cutter (40) covers the notch (26) of the lancet (22). Additionally, the cutter (40) may be further positioned relative to the lancet (22) so that the sharp distal tip (24) of the lancet (22) may protrude from the open distal end (42) of the cutter (40).

[0028] Once the needle assembly 20 is positioned proximal to the lesion (LE), the puncturer 22 may be advanced relative to the cutter 40, as shown in FIG. 4. In some versions, the puncturer 22 may be rapidly launched into the lesion (LE). In other versions, as described in more detail below, the movement of the puncturer 22 may be less rapid. In yet other versions, the needle assembly 20 may initially be in the position shown in FIG. 4 (e.g., with the puncturer 22 advanced relative to the cutter 40), and the needle assembly 20 may be inserted into the lesion (LE) to the position shown in FIG. 4.

[0029] Regardless of the particular steps used to reach the position shown in Figure 4, it should be understood that at this stage, needle assembly (20) is positioned to sever a tissue sample. In particular, as lancing device (22) advances relative to cutter (40), notch (26) is exposed to the tissue. At this position, tissue may prolapse or otherwise enter or fill notch (26).

[0030] Once notch (26) is exposed to the tissue, cutter (40) may be advanced relative to notch (26) to sever the tissue using tapered edge (43). As best seen in FIG. 5, cutter (40) may be advanced relative to lancing device (22) to completely cover notch (22). As cutter (40) advances, the tissue sample may be severed and enter notch (26). In some versions, cutter (40) may be advanced at a relatively high speed by any one of drive assemblies (200, 400) described herein. As described in more detail below, such a relatively high speed may, in some applications, be referred to as a spring-activated firing.

[0031] After advancement of cutter (40) to sever the tissue sample, lancing device (22) may be retracted relative to cutter (40), as shown in FIG. 6. As can be seen, lancing device (22) may be retracted proximally within tissue collection assembly (80), while cutter (40) remains generally stationary or otherwise in a distal position. Although not shown, it should be understood that one or more components of tissue collection assembly (80) may remove the severed tissue sample from notch (26) for storage within one or more portions of the tissue collection assembly. Additional tissue samples may then be collected by repeating the process described above with respect to FIGS. 3-6.

[0032] II. Drive Assembly Embodiments for Core Needle Biopsy Devices As noted above, it may be desirable to incorporate a drive assembly into one or more portions of biopsy device 10 to facilitate manipulation of portions of needle assembly 20 and / or tissue collection assembly 80. While a suitable drive assembly can take a variety of forms, in some versions it may be desirable for such a drive assembly to be configured to limit certain movements of one or more portions of needle assembly 20. For example, when biopsy device 10 is used to extract a tissue sample from an area adjacent to sensitive anatomical structures, one or more portions of needle assembly 20 may have a tendency to contact the sensitive anatomical structures. Therefore, it may be desirable to incorporate one or more features into a suitable drive assembly to limit or restrict certain movements of needle assembly 20 to reduce or eliminate the likelihood of this contact.

[0033] A. Drive Assembly Example with Axial Offset Drive 7 illustrates a drive assembly 200 that may be readily incorporated into the biopsy device 10 described above. As noted above, the drive assembly 200 may generally be configured to manipulate portions of the needle assembly 20, such as the lancing device 22 and the cutter 40. In some versions, this manipulation may include driving the lancing device 22 and / or the cutter 40 through a predetermined sequence for cocking, firing, and sample collection.

[0034] To facilitate such sequential operation, the drive assembly 200 includes a lancing device drive assembly 210 and a cutter drive assembly 310. As described in more detail below, the lancing device drive assembly 210 and the cutter drive assembly 310 are generally interconnected and generally configured to interact with one another. As a result of this interconnected configuration, the lancing device drive assembly 210 and the cutter drive assembly 310 may be operated to move the lancing device 22 and the cutter 40 independently and in a predetermined sequence with a relatively compact size across the axial dimension.

[0035] Lance drive assembly (210) may be in communication with lance (22), such that lance drive assembly (210) may be configured to drive lance (22) through a predetermined motion sequence independently of cutter (40), in cooperation with cutter (40), or both. Additionally, as described in more detail below, lance drive assembly (210) may be in communication with one or more elements of cutter drive assembly (310) to drive elements of cutter (40) and / or cutter (40).

[0036] As best seen in Figure 8A, the lancing device drive assembly 210 includes a lead screw drive shaft 212, a latch mechanism 220, a lancing device lead screw 240 (also referred to as a primary lead screw or lancing device driver), a cutter lead screw 250 (also referred to as a secondary lead screw or cutter driver), and a lancing device carriage 270. Generally, the lancing device drive assembly 210 is configured such that rotational movement of the lancing device lead screw 240 directly moves the lancing device carriage 270, thereby moving the lancing device 22 via the lancing device carriage 270.

[0037] The lead screw drive shaft 212 is generally configured to drive the rotational movement of the lancing device lead screw 240 and the cutter lead screw 250. The lead screw drive shaft 212 extends proximally from the lancing device lead screw 240 and is generally rigidly fixed to the lancing device lead screw 240 such that movement of the lead screw drive shaft 212 corresponds to movement of the lancing device lead screw 240. The lead screw drive shaft 212 further includes a drive gear 214 which may be integrally fastened to the lead screw drive shaft 212 to drive the rotational movement of the lead screw drive shaft 212. Thus, the drive gear 214 may be configured to drive the rotational movement of the lancing device lead screw 240 via the lead screw drive shaft 212. Although not shown, it should be understood that the drive gear (214) may mesh with other components of the biopsy device (10), such as a motorized assembly, to drive the rotational movement of the lead screw drive shaft (212).

[0038] The puncturer lead screw (240) extends distally from the lead screw drive shaft (212). The puncturer lead screw (240) is generally cylindrical in shape and includes a threaded portion (242) and a hard stop (244) at the proximal end of the threaded portion (242). As will be appreciated, the threaded portion (242) may generally be configured to engage the puncturer carriage (270) to convert rotational motion of the puncturer lead screw (240) into translational motion of the puncturer (22) via the puncturer carriage (270). Similarly, the hard stop (244) is configured to engage a portion of the puncturer carriage (270) to provide a mechanical stop to translational motion of the puncturer carriage (270) adjacent the proximal end of the puncturer lead screw (240). Although not shown, it should be understood that in some versions, the piercer lead screw (240) may further include a hard stop at the distal end of the threaded portion (242), similar to the hard stop (244) described above.

[0039] The threads (242) in this version are generally coarse, so that rotational movement of the piercer lead screw (240) can result in greater translational movement of the piercer carriage (270) than in other forms of threads described herein. The threads (242) in this version are also of a left-handed configuration, so that counterclockwise rotational movement of the piercer lead screw (240) (as viewed from the proximal end of the piercer lead screw (240) looking distally) can result in distal translational movement of the piercer carriage (270). While this version uses left-handed threads, it should be understood that in other versions, the threads can be reversed. However, as described in more detail below, such reversal of the threads (242) can result in corresponding reversals of other forms of threads associated with other components described herein.

[0040] The cutter lead screw (250) extends distally from the puncture lead screw (240) along the longitudinal axis of the puncture lead screw (240). The cutter lead screw (250) also defines a generally cylindrical shape similar to the cylindrical shape of the puncture lead screw (240). However, the diameter of the cutter lead screw (250) may generally be smaller than the diameter of the puncture lead screw (240). It should be understood that the cutter lead screw (250) may be rigidly secured to or integral with the puncture lead screw (240). Thus, rotational movement of the puncture lead screw (240) may result in corresponding rotational movement of the puncture lead screw (240).

[0041] Cutter lead screw (250) may also include a threaded portion (252). As will be appreciated, threaded portion (252) of cutter lead screw (250) may be configured to generally engage latch mechanism (220) to convert rotational motion of cutter lead screw (250) into translational motion of latch mechanism (220) along the longitudinal axis of cutter lead screw (250).

[0042] In this version, the threads 252 of the cutter lead screw 250 are generally finer than the threads 242 of the lancing device lead screw 240. Thus, rotational movement of the cutter lead screw 250 may generally result in less translational movement of the latch mechanism 220 than the translational movement of the lancing device carriage 270 caused by the lancing device lead screw 240.

[0043] The threads 252 in this version are also the reverse of the threads 242 of the puncturer lead screw 240. In other words, the threads 252 of the cutter lead screw 250 may be of a right-hand thread configuration such that counterclockwise rotational movement of the cutter lead screw 250 (as viewed from the proximal end of the puncturer lead screw 240, looking distally) can result in proximal translational movement of the latch mechanism 220. As will be appreciated, this reverse thread configuration may be desirable to facilitate a specific sequence of movement of the puncturer 22 and cutter 40. While this version uses right-hand threads, it should be understood that in other versions, this thread may be reversed. However, it should be understood that the reverse thread configurations described herein may be provided, even though such reverse threads 252 result in the corresponding threads 242 being reversed.

[0044] 9-11 show latch mechanism (220) in more detail. While latch mechanism (220) is characterized herein as being part of lancing device drive assembly (210), latch mechanism (220) may also be characterized as being part of cutter drive assembly (310), another part of drive assembly (200), or an entirely separate component. As will be appreciated, latch mechanism (220) is generally configured to interact with various components of drive assembly (200) to facilitate interaction between lancing device drive assembly (210) and cutter drive assembly (310).

[0045] Latch mechanism (220) includes an axial locator (222) (also referred to as a nut member) and a cam member (230). As described in more detail below, axial locator (222) and cam member (230) are generally configured to move along the longitudinal axis of cutter lead screw (250) and function cooperatively to selectively engage and / or disengage one or more portions of cutter drive assembly (310).

[0046] As best seen in FIG. 9 , the axial locator (222) defines a generally cylindrical shape. The axial locator (222) defines a threaded bore (224), a collar portion (226), and a receiving portion (228). The threaded bore (224) may extend longitudinally through the axial locator (222) and may include a threaded portion (not shown) configured to engage the threaded portion (252) of the cutter lead screw (250). It should be understood, therefore, that the axial locator (222) may be configured to translate axially along the length of the cutter lead screw (250) in response to rotational movement of the cutter lead screw (250).

[0047] Both collar portion (226) and receiving portion (228) are configured to function cooperatively to receive and position cam member (230) relative to axial locator (222). Collar portion (226) extends outward from receiving portion (228) to define a flange-like structure. As described in more detail below, collar portion (226) is generally configured to engage one or more portions of cutter drive assembly (310) to associate movement of latch mechanism (220) with cutter drive assembly (310). Optionally, a distal portion of collar portion (226) may be beveled, angled, or radiused to facilitate engagement with cutter drive assembly (310). Meanwhile, receiving portion (228) defines a generally smooth cylindrical surface configured to be received within a portion of cam member (230), as described in more detail below.

[0048] The cam member (230) is generally configured to receive the axial locator (222) and rotate relative to the axial locator (222). The cam member (230) includes a body (232) defining a receiving bore (234), one or more cam features (236) projecting from an outer surface of the body (232), and one or more axial protrusions (238) extending axially from the body (232). The receiving bore (234) is generally configured to receive at least a portion of the axial locator (222), and the cam features (236) and the axial protrusions (238) are generally configured to facilitate operation of the cam member (230) relative to the axial locator (222) for engagement with one or more portions of the cutter drive assembly (310).

[0049] As best seen in Figures 10 and 11, the present version of cam member (230) includes a pair of cam features (236), although other versions may use other suitable numbers. Each cam feature (236) is generally configured to engage a portion of cutter drive assembly (310) upon rotational movement of cam member (230), as described in more detail below. To facilitate such engagement, the portion of each cam member (230) may be sloped or contoured. In other words, each cam feature (236) may include a cam surface to drive movement of one or more portions of cutter drive assembly (310).

[0050] This version of the cam member (230) similarly includes a pair of axial protrusions (238) corresponding to each cam feature (236). Each axial protrusion (238) may be disposed between each cam feature (236) approximately around the circumference of the cam member (230). As will be appreciated, this configuration may define a pocket or open space adjacent each cam feature (236) to provide access to both the axial protrusions (238) and the cam feature (236). Specifically, such pocket or open space may allow one or more portions of the cutter drive assembly (310) to extend into the cam member (230) to engage each cam feature (236). Furthermore, such pocket or open space may provide access to one or more surfaces of each axial protrusion (238) for manipulating the cam member (230) via the one or more axial protrusions (238).

[0051] 12 shows the cutter drive assembly 310 in more detail. As can be seen, the cutter drive assembly 310 includes a cutter spring 312 and a cutter carriage 320. Furthermore, it should be understood that, depending on the context, the latch mechanism 220 may be characterized as part of the cutter drive assembly 310 rather than the lancing assembly 210, as the latch mechanism 220 may engage elements of both assemblies 210, 310. As will be appreciated, the cutter drive assembly 310 is generally configured to engage the lancing assembly 210 and other elements of the drive assembly 200 to sequentially activate and fire the cutter 40.

[0052] Cutter carriage (320) includes a cutter collar (324), a tissue manipulator (326), and a carriage body (322) defining a proximal receiving end (330). Cutter collar (324) is configured to receive the proximal end of cutter (40) such that cutter (40) can extend distally from cutter collar (324). In this version, cutter (40) can be rigidly secured to cutter collar (324). Alternatively, in other versions, cutter collar (324) can be threaded, keyed, or otherwise structured to allow cutter (40) to be removably secured to cutter collar (324). Cutter collar (324) is of a generally hollow configuration to facilitate access to the proximal end of cutter (40) by lancet (22) and / or other structures.

[0053] The tissue manipulator (326) is disposed between the cutter collar (324) and the proximal receiving end (330). The tissue manipulator (326) is generally configured to direct tissue from the lancing device (22) into a tissue sample chamber or other structure during operation of the drive assembly (200). Thus, the tissue manipulator (326) is configured to receive at least a portion of the lancing device (22) such that the lancing device (22) can extend and move through the tissue manipulator (326). In some versions, the tissue manipulator (326) can be used in conjunction with other features, such as a flexible member, wiper, or blade feature. In such a version, the tissue manipulator (326) and associated features may be configured in accordance with one or more teachings of U.S. patent application Ser. No. 63 / 316,184, entitled "Sample Management for Core Needle Biopsy Device," filed March 3, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0054] The proximal receiving end (330) of the carriage body (322) is generally configured to engage various components of the drive assembly (200) so that movement of the cutter carriage (320) drives movement of the cutter (40). Specifically, the proximal receiving end (330) defines a driver bore (332), a shaft bore (334), and a piercer bore (336). The bores (332, 334, 336) may be configured to provide clearance for certain elements of the drive assembly (200) and / or biopsy device (10) through the cutter carriage (320), as described in more detail below. While in this version holes (332, 334, 336) are shown as defining a generally cylindrical passageway through a portion of cutter carriage (320), it should be understood that in other versions any one or more of holes (332, 334, 336) may use various shapes or may be omitted entirely.

[0055] The proximal receiving end (330) further includes one or more retaining arms (340) extending proximally from a proximal face of the proximal receiving end (330). The retaining arms (340) are generally configured to resiliently engage a portion of the latch mechanism (220) to allow selective coupling of the cutter drive assembly (310) to the lancing device drive assembly (210), as described in more detail below. Each retaining arm (340) includes a respective extension member (342) and engagement member (344). Each extension member (342) is generally configured to have a degree of rigidity as well as a degree of flexibility. As described in more detail below, this combination of rigidity and flexibility may be desirable to facilitate selective coupling and decoupling of the latch mechanism (220).

[0056] Each engagement member (344) is generally configured as a tooth or detent. As will be appreciated, this configuration may allow each engagement member (344) to engage with a collar portion (226) of an axial locator (222). Specifically, each engagement member (344) includes a flat surface (346) and an angled surface (348) that projects proximally relative to the flat surface (346). As described in further detail below, the flat surface (346) may be configured to engage the collar portion (226) of an axial locator (222) for fastening, and the angled surface (348) may be configured to engage the collar portion (226) for operation of the respective retention arm (340) during fastening.

[0057] In this configuration, the proximal receiving end (330) includes a pair of retaining arms (340) oriented opposite one another around a circumference corresponding approximately to the diameter of the axial locator (222). In other versions, any suitable number of retaining arms (340) may be used, such as three, four, or more. Alternatively, in yet other versions, the retaining arms (340) may be configured as a single element with undercuts formed in its structure to facilitate similar functionality within a single-element component.

[0058] Cutter spring (312) is configured to engage proximal receiving end (330) to drive cutter carriage (320) distally during firing of cutter (40). Specifically, cutter spring (312) includes a coil spring configured to be disposed between proximal receiving end (330), retaining arm (340), and latch mechanism (220). As described in more detail below, cutter spring (312) is configured to be compressed between proximal receiving end (330) and latch mechanism (220) to store potential energy that can be released during firing of cutter (40).

[0059] The drive assembly (200) further includes a control shaft (360) (also referred to as an actuation mechanism, control, or trip mechanism) that may be configured to interact with the cutter drive assembly (310) to initiate movement of the cutter (40) through a predetermined movement sequence. As best seen in FIG. 13, the control shaft (360) includes an elongated shaft (362) having a drive gear (364), a latch portion (370), and a tissue manipulation portion (380). The elongated shaft (362) defines a generally cylindrical cross-section and is configured to extend from the lancing device drive assembly (210) to the cutter drive assembly (310).

[0060] The drive gear 364 is configured to engage a gear coupled to a motor or other drive mechanism to drive the rotational movement of the control shaft 360. In some versions, the drive gear 364 may be driven by the same motor used to drive the gear 214 of the lancing device drive assembly 210 using a transmission, gearing, and / or other mechanism. In other versions, the drive gear 364 may be driven by a dedicated motor. In still other versions, the drive gear 364 may be manually driven by a knob, thumbwheel, crank, or other manual drive mechanism.

[0061] The latch portion (370) is disposed along the elongate shaft (362) between the drive gear (364) and the tissue manipulation portion (380). The latch portion (370) is generally configured to engage a portion of the latch mechanism (220) to control one or more operations of the cutter drive assembly (310). Specifically, the latch portion (370) includes an actuator (372) that protrudes outwardly from the elongate shaft (362). As described in more detail below, the actuator (372) is configured to engage one or more of the axial protrusions (238) of the cam member (230) to selectively release the cutter carriage (320) from the latch mechanism (220).

[0062] The tissue manipulation portion (380) is disposed proximate the distal end of the elongate shaft (362). The tissue manipulation portion (380) is generally configured to manipulate a tissue sample out of the lancing device (22) and into the tissue chamber in response to rotation of the control shaft (360). The tissue manipulation portion (380) may include various features to facilitate such function. In some versions, the tissue manipulation portion (380) may be configured according to one or more teachings of U.S. Patent Application No. 63 / 316,184, filed March 3, 2022, entitled "Sample Management for Core Needle Biopsy Device," the disclosure of which is incorporated herein by reference in its entirety.

[0063] 14-19 illustrate the use of a drive assembly (200) coupled to a biopsy device (10) to collect one or more tissue samples using a single insertion of a needle assembly (20). As best seen in FIG. 14, the drive assembly (200) may initially start in an initial configuration (also referred to as a home or retrieval configuration). To transition to the initial configuration, the lancing screw (240) may rotate to drive the lancing carriage (270) proximally via the threads (242). The same rotational movement of the lancing screw (240) may also drive distal translational movement of the latch mechanism (220) along the cutter lead screw (250) via the threads (252), which may be of opposite pitch relative to the threads (242).

[0064] Once the rotational movement of the lancing screw (240) is completed and the drive assembly (200) is positioned in the initial position, the lancing carriage (270) may be fully retracted proximally relative to the lancing screw (240). In this position, the lancing device (22) may be in its most proximal position. In such a position, the notch (26) may be aligned with the tissue manipulator (326) of the cutter carriage (320). Thus, the initial configuration may be used as a starting or home position, but the initial configuration may also be used as a sample collection position, as described in more detail below.

[0065] Also in the initial position, cutter carriage 320 may be fully advanced distally relative to cutter lead screw 250. Specifically, latch mechanism 220 may be advanced distally via cutter lead screw 250 to engage cutter carriage 320 and drive cutter carriage 320 distally to the initial position shown in FIG. 14 . In this position, cutter 40 may be in its distal-most position (also referred to as the fired position). In some versions, cutter carriage 320 may abut against a distal hard stop within the outer housing of biopsy device 10 to prevent further distal movement of cutter 40.

[0066] As described above, latch mechanism (220) may also be fully advanced distally via cutter lead screw (250). During distal advancement of latch mechanism (220), latch mechanism (220) may engage cutter carriage (320). As best seen in FIG. 15, latch mechanism (220) may contact retaining arms (340) of cutter carriage (320). As latch mechanism (220) further advances distally, collar portion (226) of axial locator (222) may engage angled surfaces (348) of each retaining arm (340), driving retaining arms (340) away from each other until collar portion (226) is located distally of flat surface (346). Each flat surface (346) may then engage a collar portion (226) of an axial locator (222) to couple the latch mechanism (220) to the cutter carriage (320).

[0067] It should be appreciated that in some versions, coupling latch mechanism 220 to cutter carriage 320 may simultaneously compress cutter spring 312. In such use, cutter 40 may be characterized as being partially disarmed. When partially disarmed, cutter spring 312 may be fully compressed in preparation for firing cutter 40. However, the distal position of cutter carriage 320 may prevent or otherwise prevent actual firing of cutter 40.

[0068] Once the drive assembly 200 is in the initial configuration, it may be desirable to initiate an arming of the drive assembly 200. Figure 16 shows the drive assembly 200 in the armed configuration. In this version, the transition from the initial configuration to the armed configuration may be initiated by an operator providing user input (e.g., pressing a button on the biopsy device 10). Alternatively, in some versions, the transition to the armed configuration may be initiated automatically.

[0069] Regardless of the particular initiation process, the transition from the initial configuration to the armed configuration may be initiated by rotating the lancing screw 240 in the opposite direction to the direction described above, to translate the lancing screw 270 distally. Simultaneously, the cutter lead screw 250 may rotate in the same direction as the lancing screw 240, to translate the latch mechanism 220 and the cutter carriage 320 proximally. In other words, the lancing screw 270 and the cutter carriage 320 may translate in opposite directions due to the reverse-threaded threads of the lancing screw 240 and the cutter lead screw 250.

[0070] The rotational movement of the lancet lead screw 240 and the cutter lead screw 250 may continue until the lancet carriage 270 reaches the distal position shown in FIG. 16 and the cutter carriage 320 reaches the proximal position also shown in FIG. 16. With the lancet carriage 270 in the distal position, the lancet 22 may be in its distal-most position. Similarly, with the cutter carriage 320 in the proximal position, the cutter 40 may be in its proximal-most position. This results in a relative position between the lancet 22 and the cutter 40, including the notch 26 of the lancet 22 being exposed relative to the cutter 40.

[0071] In an alternative arming configuration, it may be desirable for the notch 26 of the lancing device 22 to be covered by the cutter 40. In such an alternative configuration, the rotational movement of the lancing device lead screw 240 and the cutter lead screw 250 may stop before the lancing device carriage 270 reaches the distal position. At this stage, further user input (e.g., a second button press) may be used to initiate further rotational movement of the lancing device lead screw 240 and the cutter lead screw 250 to reach their respective distal and proximal positions shown in FIG. 16 . In some versions, a series of light-emitting diodes (LEDs) may be used to indicate the status of the drive assembly 200 (e.g., one LED for arming, two LEDs for an exposed notch 26, and three LEDs for firing).

[0072] Proximal retraction of cutter carriage (320) by engagement with latch mechanism (220) may also serve to arm or cock cutter drive assembly (310) for firing. Specifically, in versions in which cutter spring (312) is compressed during transition to the initial configuration, arming or cocking may include proximal retraction of cutter carriage (320) to provide space for subsequent distal advancement of cutter carriage (320) during firing of cutter (40).

[0073] In other versions, proximal translation of the cutter carriage (320) may also be used to compress the cutter spring (312). Specifically, in some versions, the cutter spring (312) may not be compressed between the cutter carriage (320) and the latch mechanism (220), but may be positioned elsewhere relative to the cutter carriage (320). By way of example only, in some versions, the cutter spring (312) may be compressed between the cutter carriage (320) and a portion of the housing of the biopsy device (10). In such versions, compression of the cutter spring (312) may be based on movement of the cutter carriage (320) relative to the housing, rather than movement of the cutter carriage (320) relative to the latch mechanism (220). Thus, in such versions, proximal translation of the cutter carriage (320) during arming or cocking may also include compression of the cutter spring (312).

[0074] Once the drive assembly 200 is in the armed configuration, the lancet 22 and cutter 40 may be inserted into tissue and positioned near the lesion. Such insertion into tissue may be performed either with the notch 26 of the lancet 22 exposed to the cutter 40 or with the notch 26 covered by the cutter 40. Optionally, insertion at this stage may be performed in conjunction with various forms of image guidance, such as ultrasound, x-ray, or magnetic resonance imaging (MRI).

[0075] After the drive assembly (200) has been moved to the armed configuration, it may be desirable to fire the cutter (40) against the lancing device (22) to sever the tissue sample and place it into the notch (26) of the lancing device (22). Similar to that described above for the armed configuration, firing may be initiated using a user input, such as a button. Figures 17A-18C illustrate a sequence that may be performed to move the drive assembly (200) to the fired configuration shown in Figure 19.

[0076] As best seen in Figures 17A-17B, the firing sequence may begin with the control shaft (360) rotating to move the actuator (372) of the latch portion (370) toward the latch mechanism (220). At this stage, the actuator (372) may engage the axial protrusion (238), or other suitable portion of the cam member (230), causing the cam member (230) to rotate relative to the axial locator (222). As the cam member (230) rotates, the cam feature (236) may be driven into engagement with the retaining arm (340) of the cutter carriage (320).

[0077] Further rotational movement of cam member (230) may cause retaining arms (340) of cutter carriage (320) to disengage from collar portion (226) of axial locator (222). Specifically, as best seen in Figures 18A-18C, rotational movement of cam member (230) may cause cam features (236) to exert outward pressure on each retaining arm (340) of cutter carriage (320). As a result, flat surface (346) of engagement member (344) may move out of engagement with collar portion (226) of axial locator (222).

[0078] When the retaining arm (340) disengages from the axial locator (222), the cutter carriage (320) may be axially released relative to the latch mechanism (220), allowing free axial translation of the cutter carriage (320). The cutter spring (312) may then be free to decompress, driving the cutter carriage (320) distally to the firing configuration shown in FIG. 19. Once the cutter carriage (320) has moved to the firing configuration, the cutter (40) may likewise move distally relative to the lancing device (22) to place a tissue sample into the separation notch (26).

[0079] After drive assembly 200 has been moved to the firing configuration, the severed tissue sample may be collected by returning drive assembly 200 to the initial position described above and then rotating control shaft 360 to wipe the severed tissue sample from notch 26. The same process may then be repeated to obtain any number of desired tissue samples with a single insertion of needle assembly 20.

[0080] B. Alternative drive assembly with axially aligned drives 20 illustrates a drive assembly 400 that may be readily incorporated into the biopsy device 10 described above in place of the drive assembly 200 described above. Similar to the drive assembly 200 described above, this version of the drive assembly 400 may generally be configured to manipulate portions of the needle assembly 20, such as the lancing device 22 and the cutter 40. In some versions, this manipulation may include driving the lancing device 22 and / or the cutter 40 through a predetermined sequence for cocking, firing, and sample collection.

[0081] To facilitate such sequential operation, the drive assembly 400 includes a lancing device drive assembly 410 and a cutter drive assembly 510. As described in more detail below, the lancing device drive assembly 410 and the cutter drive assembly 510 are generally interconnected and generally configured to interact with one another. As a result of this interconnected configuration, the lancing device drive assembly 410 and the cutter drive assembly 510 may be operated to move the lancing device 22 and the cutter 40 independently and in a predetermined sequence with a relatively compact size across the axial dimension.

[0082] Lance drive assembly (410) may be in communication with lance (22), such that lance drive assembly (410) may be configured to drive lance (22) through a predetermined motion sequence independently of cutter (40), in cooperation with cutter (40), or both. Additionally, as described in more detail below, lance drive assembly (410) may be in communication with one or more elements of cutter drive assembly (510) to drive elements of cutter (40) and / or cutter (40).

[0083] As best seen in FIG. 21 , the lancing device drive assembly 410 includes a lead screw shaft 412, a latch mechanism 420, and a lancing device carriage 470. The lead screw shaft 412 further defines an internal lancing device lead screw 440 (also referred to as a primary lead screw or lancing device driver) and an external cutter lead screw 450 (also referred to as a secondary lead screw or cutter driver). Generally, the lancing device drive assembly 410 is configured to move the lancing device 22 via the lancing device carriage 470 by directly moving the lancing device carriage 470 via rotational movement of the lead screw shaft 412.

[0084] Lead screw shaft 412 is generally configured to drive the rotational movement of lancing device lead screw 440 and cutter lead screw 450. Lead screw shaft 412 extends axially along a longitudinal axis defined by needle assembly 20 such that lancing device lead screw 440 and cutter lead screw 450 are both positioned along the longitudinal axis defined by needle assembly 20. Lead screw shaft 412 may further include a drive gear 414 coupled thereto or integral therewith to drive the rotational movement of lead screw shaft 412. Thus, drive gear 414 may be configured to drive the rotational movement of lancing device lead screw 440 via lead screw shaft 412. Although not shown, it should be understood that drive gear (414) may mesh with other components of biopsy device (10), such as a motorized assembly, to drive rotational movement of lead screw shaft (412).

[0085] As best seen in FIG. 22 , the lancet lead screw (440) extends internally within a hollow interior defined by the lead screw shaft (412). The lancet lead screw (440) is generally cylindrical in shape and includes a threaded portion (442). While not shown, it should be understood that the lancet lead screw (440) may optionally include a hard stop (not shown) at the proximal end of the threaded portion (442) to facilitate operating functions such as initialization. As should be understood, the threaded portion (442) may generally be configured to engage the lancet carriage (470) to translate rotational motion of the lancet lead screw (440) into translational motion of the lancet (22) via the lancet carriage (470). Similarly, the hard stop may be configured to engage a portion of the puncture carriage (470) to provide a mechanical stop to the translational movement of the puncture carriage (470) adjacent the proximal end of the puncture lead screw (440).

[0086] The threads (442) in this version are generally coarse, so that rotational movement of the piercer lead screw (440) can result in greater translational movement of the piercer carriage (470) than in other forms of threads described herein. The threads (442) in this version are also of a right-hand configuration, so that clockwise rotational movement of the piercer lead screw (440) (as viewed from the proximal end of the piercer lead screw (440) looking distally) can result in distal translational movement of the piercer carriage (470). While right-hand threads are used in this version, it should be understood that in other versions, the threads can be reversed. However, as described in more detail below, such reversal of the threads (442) can result in corresponding reversals of other forms of threads associated with other components described herein.

[0087] The cutter lead screw 450 extends outwardly along the outer surface of the lead screw shaft 412. In this configuration, at least a portion of the cutter lead screw 450 may optionally overlap the lancing device lead screw 440. The cutter lead screw 450 also defines a generally cylindrical shape similar to the cylindrical shape of the lancing device lead screw 440. However, the diameter of the cutter lead screw 450 may generally be larger than the diameter of the lancing device lead screw 440, depending on the internal and external configurations of the lancing device lead screw 440 and the cutter lead screw 450, respectively. It should be understood that the cutter lead screw 450 may be rigidly secured to or integral with the lancing device lead screw 440. Thus, rotational movement of the lancing device lead screw 440 may result in corresponding rotational movement of the lancing device lead screw 440.

[0088] Cutter lead screw (450) may also include a threaded portion (452). As will be appreciated, threaded portion (452) of cutter lead screw (450) may be configured to generally engage latch mechanism (420) to convert rotational motion of cutter lead screw (450) into translational motion of latch mechanism (420) along the longitudinal axis of cutter lead screw (450).

[0089] In this version, the threads 452 of the cutter lead screw 450 are generally finer than the threads 442 of the lancing device lead screw 440. Therefore, rotational movement of the cutter lead screw 450 may generally result in less translational movement of the latch mechanism 420 than the translational movement of the lancing device carriage 470 caused by the lancing device lead screw 440. As a result of this configuration, the axial length of the threads 452 along the lead screw shaft 412 may be shorter than the axial length of the threads 442 in the lead screw shaft 412.

[0090] The threads 452 in this version are also the reverse of the threads 442 of the puncture lead screw 440. In other words, the threads 452 of the cutter lead screw 450 may be of a left-handed configuration such that clockwise rotational movement of the cutter lead screw 450 (as viewed from the proximal end of the puncture lead screw 440, looking distally) can result in proximal translational movement of the latch mechanism 420. As will be appreciated, this reverse thread configuration may be desirable to facilitate a specific sequence of movement of the puncture tool 22 and the cutter 40. While this version uses left-handed threads, it should be understood that in other versions, this thread may be reversed. However, it should be understood that the reverse thread configurations described herein may be provided, even though such reverse threads 452 result in the corresponding threads 442 being reversed.

[0091] 23 shows the lancing device carriage (470) in more detail. As can be seen, the lancing device carriage (470) is generally formed by overmolding onto a portion of the lancing device (22) adjacent its proximal end. The lancing device carriage (470) is generally configured to be received within the hollow interior of the lead screw shaft (412) for engagement with the lancing device lead screw (440). Accordingly, the lancing device carriage (470) may include a threaded portion (472) on its outer surface for engagement with the threaded portion (442) of the lancing device lead screw (440).

[0092] 24-26 show latch mechanism (420) in more detail. While latch mechanism (420) is characterized herein as being part of lancing device drive assembly (410), latch mechanism (420) may also be characterized as being part of cutter drive assembly (510), another part of drive assembly (400), or an entirely separate component. As will be appreciated, latch mechanism (420) is generally configured to interact with various components of drive assembly (400) to facilitate interaction between lancing device drive assembly (410) and cutter drive assembly (510).

[0093] Latch mechanism (420) includes axial locator (422) (also referred to as a nut member) and cam member (430). As described in more detail below, axial locator (422) and cam member (430) are generally configured to move along the longitudinal axis of cutter lead screw (450) and function cooperatively to selectively engage and / or disengage one or more portions of cutter drive assembly (510).

[0094] As best seen in FIG. 24 , the axial locator (422) defines a generally cylindrical shape. The axial locator (422) defines a threaded bore (424), a collar portion (426), and a receiving portion (428). The threaded bore (424) may extend longitudinally through the axial locator (422) and may include a threaded portion (not shown) configured to engage the threaded portion (452) of the cutter lead screw (450). It should be understood, therefore, that the axial locator (422) may be configured to translate axially along the length of the cutter lead screw (450) in response to rotational movement of the cutter lead screw (450).

[0095] Both collar portion (426) and receiver portion (428) are configured to function cooperatively to receive and position cam member (430) relative to axial locator (422). Collar portion (426) extends outwardly from receiver portion (428) to define a flange-like structure. As described in more detail below, collar portion (426) is generally configured to engage one or more portions of cutter drive assembly (510) to associate movement of latch mechanism (420) with cutter drive assembly (510). Optionally, a distal portion of collar portion (426) may be beveled, angled, or radiused to facilitate engagement with cutter drive assembly (510).

[0096] The receiving portion (428) defines a generally smooth cylindrical surface configured to receive within a portion of the cam member (430), as described in more detail below. Optionally, the receiving portion (428) may include an alignment protrusion (429). The alignment protrusion (429) may be configured to retain the cam member (430) on the axial locator (422) between the collar portion (426) and the alignment protrusion (429). In some versions, the proximal surface of the alignment protrusion (429) may be angled to facilitate assembly. Additionally, while a single alignment protrusion (429) is shown, in other versions, any suitable number of alignment protrusions (429) may be used.

[0097] The cam member (430) is generally configured to receive the axial locator (422) and rotate relative to the axial locator (422). The cam member (430) includes a body (432) defining a receiving hole (434), one or more cam features (436) projecting from an outer surface of the body (432), and one or more axial protrusions (438) extending axially from the body (432). The receiving hole (434) is generally configured to receive at least a portion of the axial locator (422), and the cam features (436) and the axial protrusions (438) are generally configured to facilitate operation of the cam member (430) relative to the axial locator (422) for engagement with one or more portions of the cutter drive assembly (510).

[0098] While the present version of cam member (430) includes a pair of cam features (436), other versions may use other suitable numbers. Each cam feature (436) is generally configured to engage a portion of cutter drive assembly (510) upon rotational movement of cam member (430), as described in more detail below. To facilitate such engagement, the portion of each cam member (430) may be sloped or contoured. In other words, each cam feature (436) may include a cam surface to drive movement of one or more portions of cutter drive assembly (510).

[0099] This version of cam member (430) includes a single proximally extending axial protrusion (438), as opposed to the pair of axial protrusions (238) discussed above with respect to cam member (240). Alternatively, in other versions, axial protrusion (438) may be comprised of multiple protrusions. Furthermore, each axial protrusion (438) may extend proximally or distally.

[0100] Axial protrusions (438) may be disposed between each cam feature (436) generally around the circumference of cam member (430). Proximal extension of axial protrusions (438) results in axial protrusions (438) extending into body (432) proximally into open spaces. Such open spaces may allow extension of one or more portions of cutter drive assembly (410) relative to cam member (430) or other components of drive assembly (400) to engage axial protrusions (438).

[0101] As best seen in Figures 25 and 26, body (432) further defines a pair of pockets (439) extending axially from a distal edge of body (432). Pockets (439) are generally configured to allow a portion of cutter drive assembly (510) to extend into a portion of body (432) in an area of ​​body (432) proximate cam feature (436). As will be appreciated, this configuration may facilitate engagement between portions of cutter drive assembly (510) and cam feature (436) upon rotational movement of cam member (430).

[0102] 27 shows the cutter drive assembly 510 in more detail. As can be seen, the cutter drive assembly 510 includes a cutter spring 512 and a cutter carriage 520. Furthermore, it should be understood that, depending on the context, the latch mechanism 420 may be characterized as part of the cutter drive assembly 510 rather than the lancing device drive assembly 410, as the latch mechanism 420 may engage elements of both assemblies 410, 510. As will be appreciated, the cutter drive assembly 510 is generally configured to engage the lancing device drive assembly 410 and other elements of the drive assembly 400 to sequentially activate and fire the cutter 40.

[0103] Cutter carriage (520) includes a cutter collar (524), a tissue manipulator (526), ​​and a carriage body (522) defining a proximal receiving end (530). Cutter collar (524) is configured to receive the proximal end of cutter (40) such that cutter (40) can extend distally from cutter collar (524). In this version, cutter (40) can be rigidly secured to cutter collar (524). Alternatively, in other versions, cutter collar (524) can be threaded, keyed, or otherwise structured to allow cutter (40) to be removably secured to cutter collar (524). Cutter collar (524) is of a generally hollow configuration to facilitate access to the proximal end of cutter (40) by lancet (22) and / or other structure.

[0104] The tissue manipulator (526) is disposed between the cutter collar (524) and the proximal receiving end (530). The tissue manipulator (526) is generally configured to direct tissue from the lancing device (22) into a tissue sample chamber or other structure during operation of the drive assembly (400). Thus, the tissue manipulator (526) is configured to receive at least a portion of the lancing device (22) such that the lancing device (22) can extend and move through the tissue manipulator (526). In some versions, the tissue manipulator (526) can be used in conjunction with other features, such as a flexible member, wiper, or blade feature. In such a version, the tissue manipulator (536) and associated features may be configured in accordance with one or more teachings of U.S. patent application Ser. No. 63 / 316,184, entitled "Sample Management for Core Needle Biopsy Device," filed March 3, 2022, the disclosure of which is incorporated by reference in its entirety into this specification.

[0105] The proximal receiving end (530) of the carriage body (522) is generally configured to engage various components of the drive assembly (400) to drive movement of the cutter (40) through movement of the cutter carriage (520). In particular, the proximal receiving end (530) defines a spring bore (532) aligned with the longitudinal axis defined by the needle assembly (20). The spring bore (532) may be configured to receive the cutter spring (512) such that the cutter spring (512) may be compressed within the spring bore (532) between a portion of the cutter carriage (520) and the latch mechanism (420), as described in further detail below. While the spring bore (532) is shown in this version as defining a generally cylindrical passageway through a portion of the cutter carriage (520), it should be understood that in other versions, the spring bore (532) may use various shapes or may be omitted entirely.

[0106] The proximal receiving end (530) further includes one or more retaining arms (540) extending proximally from a proximal face of the proximal receiving end (530). The retaining arms (540) are generally configured to resiliently engage a portion of the latching mechanism (420) to allow selective coupling of the cutter drive assembly (510) to the lancing mechanism (410), as described in more detail below. Each retaining arm (540) includes a respective extension member (542) and engagement member (544). Each extension member (542) is generally configured to have a degree of rigidity as well as a degree of flexibility. As described in more detail below, this combination of rigidity and flexibility may be desirable to facilitate selective coupling and decoupling of the latching mechanism (420).

[0107] Each engaging member (544) is generally configured as a tooth or detent. As will be appreciated, this configuration may allow each engaging member (544) to engage with a collar portion (426) of an axial locator (422). Specifically, each engaging member (544) includes a flat surface (546) and an angled surface (548) that projects proximally relative to the flat surface (546). As described in further detail below, the flat surface (546) may be configured to engage the collar portion (426) of an axial locator (422) for fastening, and the angled surface (548) may be configured to engage the collar portion (426) for operation of the respective retaining arm (540) during fastening.

[0108] In this configuration, the proximal receiving end (530) includes a pair of retaining arms (540) oriented opposite one another around a circumference corresponding approximately to the diameter of the axial locator (422). In other versions, any suitable number of retaining arms (540) may be used, such as three, four, or more. Alternatively, in yet other versions, the retaining arms (540) may be configured as a single element with undercuts formed in its structure to facilitate similar functionality within a single-element component.

[0109] Cutter spring (512) is configured to engage proximal receiving end (530) to drive cutter carriage (520) distally during firing of cutter (40). Specifically, cutter spring (512) includes a coil spring configured to be disposed between proximal receiving end (530), retaining arm (540), and latch mechanism (520). As described in more detail below, cutter spring (512) is configured to be compressed between proximal receiving end (530) and latch mechanism (420) to store potential energy that can be released during firing of cutter (40).

[0110] The drive assembly (400) further includes a control shaft (560) (also referred to as an actuation mechanism, control, or trip mechanism) that may be configured to interact with the cutter drive assembly (510) to initiate movement of the cutter (40) through a predetermined movement sequence. As best seen in FIG. 30 , the control shaft (560) includes an elongated shaft (562) having a drive gear (564), a latch portion (570), and a tissue manipulation portion (580). The elongated shaft (562) defines a generally cylindrical cross-section and is configured to extend from the lancing device drive assembly (410) to the cutter drive assembly (510).

[0111] Drive gear 564 is configured to engage a gear coupled to a motor or other drive mechanism to drive rotational movement of control shaft 560. In some versions, drive gear 564 may be driven by the same motor used to drive gear 414 of lancing device drive assembly 410 using a transmission, gearing, and / or other mechanism. In other versions, drive gear 564 may be driven by a dedicated motor. In yet other versions, drive gear 564 may be manually driven by a knob, thumbwheel, crank, or other manual drive mechanism.

[0112] The latch portion (570) is disposed along the elongate shaft (562) between the drive gear (564) and the tissue manipulation portion (580). The latch portion (570) is generally configured to engage a portion of the latch mechanism (420) to control one or more operations of the cutter drive assembly (510). Specifically, the latch portion (570) includes an actuator (572) that protrudes outwardly from the elongate shaft (562). As described in more detail below, the actuator (572) is configured to engage one or more of the axial protrusions (438) of the cam member (430) to selectively release the cutter carriage (520) from the latch mechanism (420).

[0113] The tissue manipulation portion (580) is disposed proximate the distal end of the elongate shaft (562). The tissue manipulation portion (580) is generally configured to manipulate a tissue sample out of the lancing device (22) and into the tissue chamber in response to rotation of the control shaft (560). The tissue manipulation portion (580) may include various features to facilitate such function. In some versions, the tissue manipulation portion (580) may be configured according to one or more teachings of U.S. Patent Application No. 63 / 316,184, filed March 3, 2022, entitled "Sample Management for Core Needle Biopsy Device," the disclosure of which is incorporated herein by reference in its entirety.

[0114] 31-43 illustrate the use of a drive assembly 400 coupled to a biopsy device 10 to collect one or more tissue samples using a single insertion of a needle assembly 20. As best seen in FIG. 31, the drive assembly 400 may initially start in an initial configuration (also referred to as a home or retrieval configuration). To transition to the initial configuration, the lead screw shaft 412 may rotate to drive the lancing device carriage 470 proximally via the lancing device lead screw 440 and threaded portion 442. The same rotational movement of the lead screw shaft 412 may also drive distal translational movement of the latch mechanism 420 along the cutter lead screw 450 via threaded portion 452, which may be of opposite pitch relative to threaded portion 442.

[0115] Once the rotational movement of the lead screw shaft (412) is completed and the drive assembly (400) is positioned in the initial position, the lancing device carriage (470) may be fully retracted proximally relative to the lancing device lead screw (440). In this position, the lancing device (22) may be in its most proximal position. In such a position, the notch (26) may be aligned with the tissue manipulator (526) of the cutter carriage (520), as shown in FIG. 33. Thus, the initial configuration may be used as a starting or home position, but the initial configuration may also be used as a sample collection position, as described in more detail below.

[0116] Also in the initial position, cutter carriage 520 may be fully advanced distally relative to cutter lead screw 450. Specifically, latch mechanism 420 may be advanced distally via cutter lead screw 450 to engage cutter carriage 520 and drive cutter carriage 520 distally to the initial position shown in FIG. 31 . In this position, cutter 40 may be in its distal-most position (also referred to as the fired position). In some versions, cutter carriage 520 may abut against a distal hard stop within the outer housing of biopsy device 10 to prevent further distal movement of cutter 40.

[0117] As described above, the latch mechanism (420) may also be fully advanced distally via the cutter lead screw (450). During distal advancement of the latch mechanism (420), the latch mechanism (420) may engage the cutter carriage (520). As best seen in FIG. 32, the latch mechanism (520) may contact the retaining arms (540) of the cutter carriage (520). As the latch mechanism (420) further advances distally, the collar portion (426) of the axial locator (422) may engage the angled surface (548) of each retaining arm (540), driving the retaining arms (540) away from each other until the collar portion (426) is located distally of the flat surface (546). Each flat surface (546) may then engage a collar portion (426) of an axial locator (422) to couple the latch mechanism (420) to the cutter carriage (520).

[0118] It should be appreciated that in some versions, coupling latch mechanism 420 to cutter carriage 520 may simultaneously compress cutter spring 512. In such uses, cutter 40 may be characterized as being partially disarmed. When partially disarmed, cutter spring 512 may be fully compressed in preparation for firing cutter 40. However, the distal position of cutter carriage 520 may prevent or otherwise prevent actual firing of cutter 40.

[0119] Once the drive assembly 400 is in the initial configuration, it may be desirable to initiate an arming of the drive assembly 400. Figure 34 shows the drive assembly 400 in the armed configuration. In this version, the transition from the initial configuration to the armed configuration may be initiated by an operator providing user input (e.g., pressing a button on the biopsy device 10). Alternatively, in some versions, the transition to the armed configuration may be initiated automatically.

[0120] Regardless of the particular initiation process, the transition from the initial configuration to the armed configuration may be initiated by rotation of the lead screw shaft 412 in the opposite direction to that described above, to translate the lancing device carriage 470 distally via the lancing device lead screw 440. Simultaneously, the cutter lead screw 450 may rotate in the same direction as the lancing device lead screw 440, to translate the latch mechanism 420 and the cutter carriage 520 proximally. In other words, the lancing device carriage 470 and the cutter carriage 520 may translate in opposite directions due to the reverse-threaded threads of the lancing device lead screw 440 and the cutter lead screw 450.

[0121] The rotational movement of the lancet lead screw 440 and the cutter lead screw 450 may continue until the lancet carriage 470 reaches the position shown in Figure 34 and the cutter carriage 520 reaches the proximal position also shown in Figure 34. In some versions, at this stage, the lancet carriage 470 may reach its distal-most position and the cutter carriage 520 may reach its proximal-most position.

[0122] In other versions, the lancet carriage 470 and the cutter carriage 520 may optionally stop translational motion before their respective distal-most and proximal-most positions to position the lancet 22 and the cutter 40 in a pre-stop configuration. For example, as shown in FIG. 35 , the lancet carriage 470 may be partially advanced distally before its distal-most position. Similarly, the cutter carriage 520 may be partially retracted proximally before its proximal-most position. As a result of this pre-stop configuration, the lancet 22 may be positioned relative to the cutter 40 as shown in FIG. 36 . In this configuration, the lancet 22 partially extends from the cutter 40 such that the distal tip 24 protrudes from the cutter 40, but the notch 26 may remain within the cutter 40. It may be desirable to use this low-stop configuration for insertion of needle assembly 20 into tissue, as the placement of notch 26 within cutter 40 may reduce the force required to penetrate tissue. It should be understood that in some versions, drive assembly 400 may automatically stop upon transition to the low-stop configuration. After this point, further user input (e.g., a second press of the button) may be used to initiate further rotational movement of lead screw shaft 412. In some versions, a series of light-emitting diodes (LEDs) may be used to indicate the status of drive assembly 400 (e.g., one LED for armed, two LEDs for exposed notch 26, and three LEDs for fired).

[0123] After translating the lancing device carriage 470 and the cutter carriage 520 to the proximal stop configuration, the rotational movement of the lead screw shaft 412 may continue to translate the lancing device carriage 470 to its distal-most position and the cutter carriage 520 to its proximal-most position, as shown in FIG. 37. With the lancing device carriage 470 in its distal position, the lancing device 22 may be in its distal-most position. Similarly, with the cutter carriage 320 in its proximal position, the cutter 40 may be in its proximal-most position. This results in a relative position between the lancing device 22 and the cutter 40, as shown in FIG. 38, with the notch 26 of the lancing device 22 exposed relative to the cutter 40.

[0124] Proximal retraction of cutter carriage (520) by engagement with latch mechanism (420) may also serve to arm or cock cutter drive assembly (510) for firing. Specifically, in versions in which cutter spring (512) is compressed during transition to the initial configuration, arming or cocking may include proximal retraction of cutter carriage (520) to provide space for subsequent distal advancement of cutter carriage (520) during firing of cutter (40).

[0125] In other versions, proximal translation of the cutter carriage (520) may also be used to compress the cutter spring (512). Specifically, in some versions, the cutter spring (512) may not be compressed between the cutter carriage (520) and the latch mechanism (420), but may be in another position relative to the cutter carriage (520). By way of example only, in some versions, the cutter spring (512) may be compressed between the cutter carriage (520) and a portion of the housing of the biopsy device (10). In such versions, compression of the cutter spring (512) may be based on movement of the cutter carriage (520) relative to the housing, rather than movement of the cutter carriage (520) relative to the latch mechanism (420). Thus, in such versions, proximal translation of the cutter carriage (520) during arming or cocking may also include compression of the cutter spring (512).

[0126] Once the drive assembly 400 is moved to the armed configuration shown in FIGURE 34, the lancet 22 and cutter 40 may be inserted into tissue and positioned near the lesion. Such insertion into tissue may be performed with the lancet 22 notch 26 either exposed to the cutter 40 or covered by the cutter 40, as described above. Optionally, insertion at this stage may be performed in conjunction with various forms of image guidance, such as ultrasound, x-ray, or magnetic resonance imaging (MRI).

[0127] After the drive assembly (400) has been moved to the armed configuration, it may be desirable to fire the cutter (40) against the lancing device (22) to sever and deposit the tissue sample into the notch (26) of the lancing device (22). Similar to that described above for the armed configuration, firing may be initiated using a user input, such as a button. Figures 39A-40B illustrate a sequence that may be performed to move the drive assembly (400) to the fired configuration shown in Figure 41.

[0128] As best seen in Figures 39A-39B, the firing sequence may begin with the control shaft (560) rotating to move the actuator (572) of the latch portion (570) toward the latch mechanism (420). At this stage, the actuator (572) may engage the axial protrusion (438), or other suitable portion of the cam member (430), causing the cam member (430) to rotate relative to the axial locator (422). As the cam member (430) rotates, the cam feature (436) may be driven into engagement with the retaining arm (540) of the cutter carriage (520).

[0129] Further rotational movement of cam member (430) may cause retaining arms (540) of cutter carriage (520) to disengage from collar portion (426) of axial locator (422). Specifically, as best seen in FIGS. 40A-40B, rotational movement of cam member (430) may cause cam features (436) to exert outward pressure on each retaining arm (540) of cutter carriage (520). As a result, flat surface (546) of engagement member (544) may move out of engagement with collar portion (426) of axial locator (422).

[0130] When the retaining arm (540) disengages from the axial locator (422), the cutter carriage (520) may be axially released relative to the latch mechanism (420), allowing free axial translation of the cutter carriage (520). The cutter spring (512) may then be free to decompress, driving the cutter carriage (520) distally to the firing configuration shown in Figures 41-43. Once the cutter carriage (520) has moved to the firing configuration, the cutter (40) may likewise move distally relative to the lancing device (22) to place a tissue sample into the separation notch (26).

[0131] After drive assembly 400 has been moved to the firing configuration, the severed tissue sample may be collected by returning drive assembly 400 to the initial position described above and then rotating control shaft 360 to wipe the severed tissue sample from notch 26. The same process may then be repeated to obtain any number of desired tissue samples with a single insertion of needle assembly 20.

[0132] III. Exemplary Combinations The following examples describe various, non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any Claims that may be presented at any time in this application or in any subsequent application thereto. No disclaimers are intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features referred to in the examples below. Accordingly, none of the aspects or features referred to below should be considered critical unless expressly indicated otherwise later by the inventor, or by the intended inventor's successors, etc. If any Claims are presented in this application or in any subsequent application related to this application that include additional features beyond those referred to below, those additional features should not be presumed to have been added for any reason related to patentability.

[0133] Example 1 1. A core needle biopsy device comprising: a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet being slidably disposed within the cutter to sever a tissue sample within the notch of the lancet; a cutter drive assembly configured to move the cutter; a lancet drive assembly configured to move the lancet, the lancet drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the lancet drive assembly; and a latch mechanism configured to selectively couple a portion of the cutter drive assembly to a portion of the lancet drive assembly.

[0134] Example 2 2. The core needle biopsy device of claim 1, wherein the lead screw includes a lancing device lead screw and a cutter lead screw, the lancing device lead screw configured to drive translational movement of the lancing device, and the cutter lead screw configured to drive translational movement of the cutter.

[0135] Example 3 3. The core needle biopsy device of claim 2, wherein the lancing screw includes a first threaded portion and the cutter screw includes a second threaded portion, the first threaded portion being a reverse threaded portion relative to the second threaded portion.

[0136] Example 4 4. The core needle biopsy device of example 3, wherein the first threaded portion has a coarse thread relative to the second threaded portion.

[0137] Example 5 5. The core needle biopsy device of any one of Examples 2 to 4, wherein the lead screw is configured to drive translational motion of the lancing instrument and the cutter in opposite directions when the lead screw rotates in a single direction.

[0138] Example 6 6. The core needle biopsy device of any one of Examples 2 to 5, wherein the lancing device lead screw and the cutter lead screw are both external to the lead screw structure.

[0139] Example 7 6. The core needle biopsy device of any one of Examples 2 to 5, wherein the lancing device lead screw or the cutter lead screw is internal to the lead screw structure.

[0140] Example 8 8. The core needle biopsy device of any one of claims 1 to 7, wherein the lead screw is oriented along an axis that is offset relative to a longitudinal axis defined by the needle assembly.

[0141] Example 9 8. The core needle biopsy device of any one of Examples 1 to 7, wherein the lead screw is oriented along a longitudinal axis defined by the needle assembly.

[0142] Example 10 10. The core needle biopsy device of any one of claims 1 to 9, wherein the cutter drive assembly, the lancing device drive assembly, and the latch mechanism are oriented along a single axis, and the latch mechanism is disposed between a portion of the cutter drive assembly and the lancing device drive assembly.

[0143] Example 11 11. The core needle biopsy device of any one of claims 1 to 10, wherein the latch mechanism includes an axial locator and a cam member, the cam member configured to rotate relative to the axial locator to selectively decouple a portion of the cutter drive assembly from a portion of the lancing device drive assembly.

[0144] Example 12 12. The core needle biopsy device of claim 11, wherein the cam member of the latch mechanism includes one or more cam features configured to operate a portion of the cutter drive assembly upon rotational movement of the cam member relative to the axial locator.

[0145] Example 13 13. The core needle biopsy device of claim 11 or 12, further comprising a control shaft, the control shaft comprising an actuator, the actuator configured to engage the cam member of the latch mechanism to rotate the latch mechanism relative to the axial locator.

[0146] Example 14 13. The core needle biopsy device of any one of Examples 1 to 12, further comprising a control shaft configured to engage the latch mechanism and rotate relative to the latch mechanism to selectively decouple a portion of the cutter drive assembly from the lancing device drive assembly.

[0147] Example 15 15. The core needle biopsy device of any of Examples 1 to 14, wherein the lead screw is configured to drive the axial translational movement of the latch mechanism.

[0148] Example 16 1. A drive assembly for use with a core needle biopsy device, the core needle biopsy device including a hollow cutter and a puncture device disposed within the hollow cutter, the drive assembly comprising: a cutter drive assembly configured to translate the cutter; a puncture device drive assembly configured to translate the puncture device, the puncture device including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the puncture device; and a latch mechanism configured for axial translation along a portion of the lead screw, a portion of the latch mechanism being releasably coupled to a portion of the cutter drive assembly.

[0149] Example 17 The drive assembly of Example 16, wherein the cutter drive assembly includes a cutter carriage, the cutter carriage defining one or more retaining arms, the one or more retaining arms configured to releasably engage the latch mechanism.

[0150] Example 18 The drive assembly of Example 17, wherein the one or more retaining arms include a pair of retaining arms, each retaining arm of the pair being oriented in an opposite direction to the other retaining arm, and each retaining arm including a flat surface configured to engage with a portion of the latch mechanism.

[0151] Example 19 A drive assembly described in any of Examples 16 to 18, wherein the puncture drive assembly further includes a puncture carriage, the puncture carriage defining a male thread, the male thread configured to engage with the female thread defined by the lead screw.

[0152] Example 20 1. A method for using a core needle biopsy device, comprising: advancing a portion of a lancing device drive assembly relative to a cutter drive assembly to releasably couple a portion of the lancing device drive assembly to a portion of a cutter drive assembly; firing a cutter distally from a ready-to-fire position to a distal position relative to a stationary lancing device after releasably coupling the portion of the lancing device drive assembly to the portion of the lancing device drive assembly; and retracting the lancing device relative to the cutter to expose a notch in the lancing device relative to a proximal end of the cutter.

[0153] Example 21 21. The method of claim 20, wherein the step of firing the cutter includes decoupling the portion of the lancing device drive assembly from the portion of the cutter drive assembly.

[0154] Example 22 22. The method of claim 21, wherein the act of decoupling the portion of the lancing device drive assembly from the portion of the cutter drive assembly includes rotating a cam member relative to the cutter drive assembly.

[0155] Example 23 23. The method of any of Examples 20 to 22, further comprising advancing the puncture device relative to the cutter after the step of retracting the puncture device, wherein the act of advancing the puncture device comprises retracting the cutter simultaneously with the advancement of the puncture device.

[0156] Example 24 24. The method of example 23, wherein the act of retracting the cutter simultaneously with advancing the lancet is performed with the advancement of the lancet at a higher speed than the retraction of the cutter.

[0157] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. While some such potential modifications have been mentioned, others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. described above are illustrative and not required. Accordingly, it is understood that the scope of the present invention should be considered in relation to the following claims, and is not limited to the details of structure and operation shown and described in the specification and drawings.

[0158] It should be understood that any of the variations of the devices described herein may include various other features in addition to or in place of those described above. Also, by way of example only, any of the devices described herein may include one or more of the various features disclosed in any of the various references incorporated by reference herein. It should be understood that the teachings herein are readily applicable to any device described in any of the other references cited herein, and as a result, the teachings herein can be readily combined in numerous ways with the teachings of any of the references cited herein. Other types of devices that can incorporate the teachings herein will be apparent to those skilled in the art.

[0159] It should be recognized that any patent, publication, or other disclosure material referred to herein as being incorporated by reference, in whole or in part, is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, statements, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein will take precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, referred to as being incorporated herein by reference but that contradicts existing definitions, statements, or other disclosure material set forth herein, is incorporated only to the extent that no contradiction arises between the incorporated material and the existing disclosure material.

[0160] [Embodiment] (1) A core needle biopsy device, comprising: (a) a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet slidably disposed within the cutter to sever a tissue sample into the notch of the lancet; (b) a cutter drive assembly configured to move the cutter; (c) a lancing device drive assembly configured to move the lancing device, the lancing device drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the lancing device drive assembly; (d) a latch mechanism configured to selectively couple a portion of the cutter drive assembly to a portion of the lancing assembly; The core needle biopsy device. (2) The core needle biopsy device of embodiment 1, wherein the lead screw includes a puncture device lead screw and a cutter lead screw, the puncture device lead screw is configured to drive the translational motion of the puncture device, and the cutter lead screw is configured to drive the translational motion of the cutter. (3) The core needle biopsy device of claim 2, wherein the lancet lead screw includes a first threaded portion, the cutter lead screw includes a second threaded portion, and the first threaded portion is a reverse-threaded threaded portion relative to the second threaded portion. (4) The core needle biopsy device of claim 3, wherein the first threaded portion has a coarse thread relative to the second threaded portion. (5) A core needle biopsy device according to any one of embodiments 2 to 4, wherein when the lead screw rotates in a single direction, the lead screw drives translational motion of the puncture device and the cutter in opposite directions.

[0161] (6) A core needle biopsy device according to any one of claims 2 to 5, wherein the lancet lead screw and the cutter lead screw are both external to the lead screw structure. (7) The core needle biopsy device according to any one of embodiments 2 to 5, wherein the lancet feed screw or the cutter feed screw is internal to the feed screw structure. (8) A core needle biopsy device according to any one of claims 1 to 7, wherein the lead screw is oriented along an axis that is offset from the longitudinal axis defined by the needle assembly. (9) A core needle biopsy device according to any one of claims 1 to 7, wherein the lead screw is oriented along a longitudinal axis defined by the needle assembly. (10) A core needle biopsy device according to any one of embodiments 1 to 9, wherein the cutter drive assembly, the puncture device drive assembly, and the latch mechanism are oriented along a single axis, and the latch mechanism is disposed between a portion of the cutter drive assembly and the puncture device drive assembly.

[0162] (11) The core needle biopsy device of any one of claims 1 to 10, wherein the latch mechanism includes an axial locator and a cam member, the cam member configured to rotate relative to the axial locator to selectively decouple a portion of the cutter drive assembly from a portion of the lancet drive assembly. (12) The core needle biopsy device of embodiment 11, wherein the cam member of the latch mechanism includes one or more cam features configured to operate a portion of the cutter drive assembly upon rotational movement of the cam member relative to the axial locator. (13) The core needle biopsy device of any one of claims 11 to 12, further comprising a control shaft, the control shaft including an actuator, the actuator configured to engage the cam member of the latch mechanism to rotate the latch mechanism relative to the axial locator. (14) The core needle biopsy device of any one of claims 1 to 12, further comprising a control shaft configured to engage the latch mechanism and rotate relative to the latch mechanism to selectively decouple a portion of the cutter drive assembly from the lancing device drive assembly. (15) The core needle biopsy device according to any one of the preceding embodiments, wherein the lead screw is configured to drive the axial translational movement of the latch mechanism.

[0163] (16) A drive assembly for use with a core needle biopsy device, the core needle biopsy device including a hollow cutter and a puncture tool disposed within the hollow cutter, the drive assembly comprising: (a) a cutter drive assembly configured to translate the cutter; (b) a lancing device drive assembly configured to translate the lancing device, the lancing device drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the lancing device drive assembly; (c) a latch mechanism configured to translate axially along a portion of the lead screw, a portion of the latch mechanism releasably coupled to a portion of the cutter drive assembly; and The drive assembly comprising: (17) The drive assembly of embodiment 16, wherein the cutter drive assembly includes a cutter carriage, the cutter carriage defining one or more retaining arms, the one or more retaining arms configured to releasably engage the latch mechanism. (18) The drive assembly of embodiment 17, wherein the one or more retaining arms include a pair of retaining arms, each retaining arm of the pair oriented in an opposite direction to the other retaining arm, and each retaining arm includes a flat surface configured to engage a portion of the latch mechanism. (19) The drive assembly of any one of embodiments 16 to 18, wherein the puncture drive assembly further includes a puncture carriage, the puncture carriage defining a male thread, the male thread configured to engage with the female thread defined by the lead screw. (20) A method for using a core needle biopsy device, comprising: (a) advancing a portion of the lancing assembly relative to a cutter drive assembly so as to releasably couple a portion of the lancing assembly to a portion of the cutter drive assembly; (b) releasably coupling the portion of the lancing device drive assembly to the portion of the lancing device drive assembly, and then firing a cutter distally from a cocked position to a distal position relative to the stationary lancing device; (c) retracting the lancet relative to the cutter to expose a notch in the lancet relative to the proximal end of the cutter; The method comprising:

[0164] (21) The method of claim 20, wherein the step of firing the cutter includes decoupling the portion of the lancing device drive assembly from the portion of the cutter drive assembly. (22) The method of claim 21, wherein the act of decoupling the portion of the lancing device drive assembly from the portion of the cutter drive assembly includes rotating a cam member relative to the cutter drive assembly. (23) A method according to any one of embodiments 20 to 22, further comprising advancing the puncture device relative to the cutter after the step of retracting the puncture device, wherein the act of advancing the puncture device comprises retracting the cutter simultaneously with the advancement of the puncture device. (24) The method of embodiment 23, wherein the act of retracting the cutter simultaneously with advancing the lancet is performed with the advancement of the lancet at a higher speed than the retraction of the cutter.

Claims

1. 1. A core needle biopsy device comprising: (a) a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet slidably disposed within the cutter to sever a tissue sample into the notch of the lancet; (b) a cutter drive assembly configured to move the cutter; (c) a lancing device drive assembly configured to move the lancing device, the lancing device drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the lancing device drive assembly; (d) a latch mechanism configured to selectively couple a portion of the cutter drive assembly to a portion of the lancing assembly; The core needle biopsy device.

2. 2. The core needle biopsy device of claim 1, wherein the lead screw comprises a lancing device lead screw and a cutter lead screw, the lancing device lead screw configured to drive translational movement of the lancing device and the cutter lead screw configured to drive translational movement of the cutter.

3. 3. The core needle biopsy device of claim 2, wherein the lancing screw includes a first threaded portion and the cutter screw includes a second threaded portion, the first threaded portion being a reverse threaded portion relative to the second threaded portion.

4. The core needle biopsy device of claim 3 , wherein the first threaded portion has a coarse thread relative to the second threaded portion.

5. The core needle biopsy device of any one of claims 2 to 4, wherein the lead screw is configured to drive translational motion of the lancet and the cutter in opposite directions when the lead screw rotates in a single direction.

6. The core needle biopsy device of claim 2 , wherein the lancing device lead screw and the cutter lead screw are both external to the lead screw structure.

7. The core needle biopsy device of claim 2 , wherein the lancing device lead screw or the cutter lead screw is internal to the lead screw structure.

8. The core needle biopsy device of claim 1 , wherein the lead screw is oriented along an axis that is offset from a longitudinal axis defined by the needle assembly.

9. The core needle biopsy device of claim 1 , wherein the lead screw is oriented along a longitudinal axis defined by the needle assembly.

10. 2. The core needle biopsy device of claim 1, wherein the cutter drive assembly, the lancing device drive assembly, and the latch mechanism are oriented along a single axis, and the latch mechanism is disposed between a portion of the cutter drive assembly and the lancing device drive assembly.

11. 2. The core needle biopsy device of claim 1, wherein the latch mechanism includes an axial locator and a cam member, the cam member configured to rotate relative to the axial locator to selectively decouple a portion of the cutter drive assembly from a portion of the lancing assembly.

12. 12. The core needle biopsy device of claim 11, wherein the cam member of the latch mechanism includes one or more cam features configured to manipulate a portion of the cutter drive assembly upon rotational movement of the cam member relative to the axial locator.

13. 13. The core needle biopsy device of claim 11 or 12, further comprising a control shaft, the control shaft including an actuator, the actuator configured to engage the cam member of the latch mechanism to rotate the latch mechanism relative to the axial locator.

14. 10. The core needle biopsy device of claim 1, further comprising a control shaft configured to engage the latch mechanism and rotate relative to the latch mechanism to selectively decouple a portion of the cutter drive assembly from the lancing device drive assembly.

15. The core needle biopsy device of claim 1 , wherein the lead screw is configured to drive axial translational movement of the latch mechanism.

16. 1. A drive assembly for use with a core needle biopsy device, the core needle biopsy device including a hollow cutter and a lancing device disposed within the hollow cutter, the drive assembly comprising: (a) a cutter drive assembly configured to translate the cutter; (b) a lancing device drive assembly configured to translate the lancing device, the lancing device drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the lancing device drive assembly; (c) a latch mechanism configured to translate axially along a portion of the lead screw, a portion of the latch mechanism releasably coupled to a portion of the cutter drive assembly; and The drive assembly comprising:

17. 17. The drive assembly of claim 16, wherein the cutter drive assembly includes a cutter carriage, the cutter carriage defining one or more retaining arms, the one or more retaining arms configured to releasably engage the latch mechanism.

18. 20. The drive assembly of claim 17, wherein the one or more retaining arms include a pair of retaining arms, each retaining arm of the pair oriented opposite the other retaining arm, and each retaining arm including a flat surface configured to engage a portion of the latch mechanism.

19. 19. The drive assembly of any of claims 16-18, wherein the lancing device drive assembly further includes a lancing device carriage defining external threads configured to engage internal threads defined by the lead screw.

20. 1. A method for using a core needle biopsy device, comprising: (a) advancing a portion of the lancing assembly relative to a cutter drive assembly so as to releasably couple a portion of the lancing assembly to a portion of the cutter drive assembly; (b) releasably coupling the portion of the lancing device drive assembly to the portion of the lancing device drive assembly, and then firing a cutter distally from a cocked position to a distal position relative to the stationary lancing device; (c) retracting the lancet relative to the cutter to expose a notch in the lancet relative to the proximal end of the cutter; The method comprising:

21. 21. The method of claim 20, wherein the step of firing the cutter includes decoupling the portion of the lancing device drive assembly from the portion of the cutter drive assembly.

22. 22. The method of claim 21, wherein the act of decoupling the portion of the lancing assembly from the portion of the cutter drive assembly comprises rotating a cam member relative to the cutter drive assembly.

23. 23. The method of any of claims 20-22, further comprising, after the step of retracting the lancet, advancing the lancet relative to the cutter, wherein the act of advancing the lancet includes retracting the cutter simultaneously with advancing the lancet.

24. 24. The method of claim 23, wherein the act of retracting the cutter simultaneously with advancing the lancing device is performed with the advancement of the lancing device at a higher rate than the retraction of the cutter.

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