Core needle biopsy device for collecting multiple samples with a single insertion

Abstract

To provide a biopsy device that allows single insertion with multiple samples obtained while using a core needle type device.SOLUTION: A core needle biopsy device includes a body, a needle assembly 20, and a drive assembly. The needle assembly extends distally from the body and includes a hollow piercer 22 and a hollow cutter 40. The piercer is disposed within the cutter. The cutter includes a distal tip 24 and a swaged portion 50 proximate to the distal tip. The drive assembly is configured to selectively cock and fire the piercer and the cutter.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 62 / 712,470, entitled "Core Needle Biopsy Device for Collecting Multiple Samples in a Single Insertion," filed July 31, 2018, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Biopsy samples are taken in a variety of ways in a variety of medical procedures, including open and percutaneous methods, using a variety of devices. For example, some biopsy devices may be fully operable by a user using one hand, with a single insertion, to obtain one or more biopsy samples from a patient. Additionally, some biopsy devices may be connected to a vacuum module and / or a control module for the transmission of fluids (e.g., pressurized air, saline, atmospheric air, vacuum, etc.), power, and / or commands. Other biopsy devices may be fully or at least partially operable without being connected or otherwise coupled to another device.

[0003] One technique for collecting breast biopsies involves the use of a core needle biopsy device. Core needle biopsy devices often utilize a sharp, rigid perforator with a lateral tissue-receiving notch located adjacent the distal end of the perforator. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severed tissue sample is then stored within the notch until both the perforator and cutting sheath are removed from the patient. Thus, core needle biopsy devices can collect only one tissue sample per insertion of the perforator and cutting sheath.

[0004] Another technique for performing a breast biopsy involves using a vacuum-assisted breast biopsy device. In contrast to core needle breast biopsy procedures, vacuum-assisted breast biopsy devices allow the probe to excise multiple samples without the need to withdraw the probe from the breast after all samples have been collected. For example, in vacuum-assisted breast biopsy devices, a hollow needle is used to penetrate tissue. The hollow needle includes a lateral opening adjacent to a sharp distal tip. A hollow cutter is disposed inside the hollow needle and moved axially relative to the lateral opening of the needle to cut the tissue sample. Once the tissue sample is cut by the hollow cutter, the tissue sample is transported axially within the cutter and collected in a tissue collection device.

[0005] Examples of vacuum-assisted biopsy devices and biopsy system components are described in U.S. Patent No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," issued June 18, 1996; U.S. Patent No. 6,086,544, entitled "Control Apparatus for an Automated Surgical Biopsy Device," issued July 11, 2000; U.S. Patent No. 7,442,171, entitled "Remote Thumbwheel for a Surgical Biopsy Device," issued October 8, 2008; U.S. Patent No. 7,854,706, entitled "Clutch and Valving System for Tetherless Biopsy Device," issued December 1, 2010; U.S. Patent No. 7,854,706, entitled "Vacuum Timing Algorithm for Biopsy," issued May 10, 2011; No. 7,938,786 entitled "Biopsy Sample Storage Device," issued February 1, 2012; U.S. Patent No. 8,118,755 entitled "Biopsy Sample Storage," issued February 1, 2012; and U.S. Patent No. 8,206,316 entitled "Tetherless Biopsy Device with Reusable Portion," issued June 26, 2012. The disclosures of each of the above U.S. patents are incorporated herein by reference.

[0006] Exemplary 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; 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.

[0007] Although several systems and methods have been made and used for obtaining and processing biopsy samples, it is believed that no one prior to the inventors has made or used the invention as set forth in the appended claims.

[0008] While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed the invention will be better understood from the following description of specific embodiments considered in conjunction with the accompanying drawings, in which like reference numerals refer to the same elements, and in which some components or portions of components are shown in perspective view as represented by dashed lines. [Brief explanation of the drawings]

[0009] [Figure 1] 1 shows a perspective view of an exemplary biopsy device. [Figure 2] 2 shows a detailed perspective view of a needle assembly of the biopsy device of FIG. 1. [Figure 3] FIG. 3 shows a side view of the needle assembly of FIG. 2. [Figure 4] 4 shows a vertical cross-sectional view of the needle assembly of FIG. 2, taken along line 4-4 of FIG. 2. [Figure 5] 4 shows a detailed vertical cross-sectional view of the needle assembly of FIG. 2, taken along line 4-4 of FIG. 2. [Figure 6] 2 shows a perspective view of the internal components of the biopsy device of FIG. 1. [Figure 7] 2 shows a perspective view of a drive assembly of the biopsy device of FIG. 1. [Figure 8] 8 shows a partially exploded perspective view of the drive assembly of FIG. 7. [Figure 9] 8 shows a perspective exploded view of the cutter drive section of the drive assembly of FIG. 7; [Figure 10] 8 shows a perspective exploded view of the perforator drive of the drive assembly of FIG. 7. [Figure 11A] 11 is a cross-section taken along line 11-11 of FIG. 1, showing a vertical cross-sectional view of the biopsy device of FIG. 1 with the drive assembly of FIG. 7 in an initial position. [Figure 11B] 8 shows another cross-sectional view of the biopsy device of FIG. 1 with the drive assembly of FIG. 7 in a cocked position. [Figure 11C] 8 shows yet another cross-sectional view of the biopsy device of FIG. 1 with the drive assembly of FIG. 7 in the ready position. [Figure 11D] 8 illustrates yet another cross-sectional view of the biopsy device of FIG. 1 with the drive assembly of FIG. 7 in a partially fired position. [Figure 11E] 8 illustrates yet another cross-sectional view of the biopsy device of FIG. 1 with the drive assembly of FIG. 7 in a fully fired position. [Figure 12A] 3 shows a side view of the needle assembly of FIG. 2 with the needle assembly positioned just before the suspicious lesion. [Figure 12B] 3 shows another side view of the needle assembly of FIG. 2 with the perforator of the needle assembly fired into the suspected lesion. [Figure 12C] 3 shows yet another side view of the needle assembly of FIG. 2 with the cutter of the needle assembly fired into the suspected lesion. DETAILED DESCRIPTION OF THE INVENTION

[0010] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be embodied 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 arrangements shown.

[0011] The following description of specific 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 be apparent to those skilled in the art from the following description, which is an example and one of the best modes contemplated for carrying out the invention. As will be understood, the present invention is capable of other various and obvious aspects, all without departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature, and not as limiting.

[0012] Biopsy devices can 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 individually hold each tissue sample separate from the other tissue samples. Such trays or strips may be removable or otherwise separable from the tissue sample holder at the end of the biopsy procedure.

[0013] Regardless of the structure in which the tissue sample is stored, the tissue sample can be collected using a biopsy device under the guidance of various imaging techniques, such as ultrasound image guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, and breast-specific gamma imaging ("BSGI") guidance. Each procedure has its own methodology based on the type of imaging guide used. The following text provides a brief description of ultrasound image-guided biopsy procedures, stereotactic guided biopsy procedures, and MRI-guided biopsy procedures.

[0014] In an ultrasound imaging-guided breast biopsy procedure, an operator places an ultrasound transducer on a patient's breast and, while viewing an ultrasound image display screen, can move the transducer to locate suspicious tissue in the patient's breast. Once the operator has located the suspicious tissue, the operator can anesthetize the target area of ​​the breast. Once the breast is anesthetized, the operator can use a scalpel to create an initial incision on the exterior of the breast at a location offset from the transducer. A needle of a breast biopsy probe, coaxially positioned within an introducer cannula, is then inserted into the breast through the initial incision. The operator holds the ultrasound transducer with one hand while moving the biopsy probe with the other. While viewing the ultrasound image on the display screen, the operator guides the needle to a location adjacent to the suspicious tissue. A cutter is used inside the probe needle to excise the tissue, which is then transported to a manual pick-up location or tissue sample chamber in the breast biopsy device. The needle of the breast biopsy device is then removed, leaving the introducer cannula in place within the breast. The introducer cannula may then be used to introduce a biopsy marker cannula for placing a biopsy site marker at the biopsy site. Once the marker is placed at the biopsy site, both the biopsy marker cannula and the introducer cannula are removed from the breast and the incision is closed using a medically acceptable method for closing a break in the skin.

[0015] In a stereotactic image-guided breast biopsy procedure, the patient is first positioned relative to an X-ray device that includes a breast localization assembly. In some procedures, the patient is positioned prone on the treatment table with at least one breast hanging through an opening in the treatment table. The breast is then compressed between a compression paddle and an X-ray receptor in a localization assembly located below the treatment table. A breast biopsy device is placed in an automatic guide device in front of the compression paddle, between the breast and the X-ray source. Once patient positioning and breast localization are complete, a scout image is acquired with the X-ray receptor at a zero-degree angle (i.e., X-rays are emitted parallel to an axis perpendicular to the X-ray receptor). If the scout image indicates that the patient is positioned in the desired position, the procedure can proceed with acquiring a stereotactic image pair. Stereotactic image pairs are acquired by directing the x-ray source at various complementary angular positions (e.g., +15° and −15°) relative to the x-ray receptor while acquiring at least one x-ray image at each position.

[0016] Furthermore, in a stereotactic image-guided breast biopsy procedure, once a suitable stereotactic image pair has been acquired, the operator can identify the target site from which a biopsy sample is desired by examining the stereotactic image pair. The target site is marked on each stereotactic image, and the exact location of the target site in a Cartesian coordinate system is calculated using an image processing module. The calculated target site location is then transmitted to an automated guide device. In response to this information, the automated guide device positions the breast biopsy probe to align it with the target site. With the breast biopsy device positioned, the operator can then fire the needle of the biopsy probe into the patient's breast, thereby positioning the needle at the target site. A cutter is used inside the probe needle to excise tissue, which is then transported to a manual pick-up position or tissue sample chamber in the breast biopsy device. After the biopsy tissue is excised, a biopsy marker cannula is inserted into the needle and used to place a biopsy site marker at the biopsy site. Once the marker is deployed at the biopsy site, the needle is removed from the breast and the incision is closed using a medically acceptable method for closing the skin break.

[0017] In an MRI-guided breast biopsy procedure, after the patient is properly positioned on the table, a targeting device (e.g., a grid and cube combination or a pillar, post, and cradle support combination) is deployed and used, and a baseline MRI image is taken to confirm the target location. A scalpel is then used to incise the breast skin. The assembly, formed by the obturator placed within the sleeve, is then inserted through the incision to penetrate the breast tissue beneath the skin. In some acceptable surgical techniques, the obturator is removed, and an imaging rod is inserted into the sleeve in its place. The imaging rod is simply defined as a rod of an appropriate shape that includes features detectable by the imaging technique being used for the biopsy procedure. An MRI image of the imaging rod is used to identify the site penetrated by the sleeve / obturator assembly. In other acceptable surgical techniques, the obturator interacts with the breast tissue, resulting in a visually observable artifact in the MRI image. After the location within the breast where the biopsy should be obtained is confirmed using both of these techniques, the obturator or imaging rod is removed.

[0018] Furthermore, in an MRI-guided breast biopsy procedure, after the obturator or imaging rod is removed, it is replaced with the needle of a breast biopsy probe within the sleeve. A cutter is used inside the needle of the probe to excise tissue, which is then transported to a manual pick-up position in the breast biopsy device or to a sample chamber of the breast biopsy device. After the biopsy tissue is excised, a biopsy marker cannula is inserted into the needle, which is used to place a biopsy site marker at the biopsy site. The needle is then removed from the sleeve. Optionally, the imaging rod or obturator is returned to the breast for re-imaging of the biopsy site. The imaging rod or obturator and sleeve are then removed.

[0019] Both vacuum-assisted biopsy devices and core needle biopsy devices may have various advantages over other devices, depending on the context. For example, one advantage of vacuum-assisted biopsy devices is that vacuum assistance allows for the removal of multiple tissue samples using a single insertion. However, while core needle biopsy devices lack this feature, their use may still be desirable. For example, core needle biopsy devices may generally have a smaller needle compared to core needle 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 removal feature of vacuum-assisted biopsy devices into core needle biopsy devices to obtain the benefits present in both styles of biopsy devices.

[0020] A preferred feature of the devices described herein that are core needle biopsy devices is that they allow for a single insertion in which multiple samples are taken while still using a core needle type device, currently believed to be the only vacuum assisted biopsy devices that have this capability.

[0021] FIG. 1 illustrates an exemplary core needle biopsy device 10 for use in a breast biopsy procedure. The core needle biopsy device 10 of this example includes a body 12 and a needle assembly 20 extending distally from the body 12. The body 12 includes a holster housing 14 and a probe housing 16. As described in further detail below, the holster housing 14 and the probe housing 16 house various components of the biopsy device 10, which are used to drive the needle assembly 20 through cutting and tissue acquisition cycles. For example, in some embodiments, the holster housing 14 may house more expensive or durable parts, allowing the holster housing 14 to be reusable. Similarly, the probe housing 16 may house less expensive or less durable parts, allowing the probe housing 16 (along with the needle assembly 20) to be disposable. In this embodiment, the holster housing 14 and the probe housing 16 are configured to couple together such that, when coupled together, the body 12 is sized and shaped to be grasped by an operator using one hand. As used herein, the terms "holster" and "probe" may imply one part receiving another, but it should be understood that no such limitation is intended. For example, in some embodiments, certain components of the holster housing 14 may be received within the probe housing 16.

[0022] Biopsy device 10 further includes a tissue sample holder 80 disposed at the distal end of body 12. In this example, tissue sample holder 80 is generally configured as a hollow compartment capable of receiving a tissue sample severed by needle assembly 20. While not shown, it should be understood that in some embodiments, tissue sample holder 80 may include a basket for holding collected tissue samples and / or filtrate from the severed tissue samples. In yet other embodiments, such baskets may be separated into separate compartments to store tissue samples in an organized arrangement. In such embodiments, the baskets may be movable to facilitate accumulation of severed tissue samples in specific compartments. It should also be understood that in some embodiments, tissue sample holder 80 is in communication with a vacuum source to facilitate transfer of tissue samples to tissue sample holder 80. Of course, various other alternative configurations for tissue sample holder 80 will be apparent to those skilled in the art in light of the teachings herein.

[0023] Figures 2-5 show the needle assembly (20) in more detail. As shown in Figure 2, the needle assembly (20) includes an elongated perforator (22) and an elongated cutter (40). As described in more detail below, the perforator (22) is generally movable relative to the cutter (40) to perforate tissue and collect a tissue sample, while the cutter is generally movable relative to the perforator (22) to sever the tissue sample. The perforator (22) includes a generally hollow, cylindrical cannula (28) having a sharpened distal tip (24) and a lateral opening (26) disposed adjacent the distal tip (24). The cannula (28) defines a lumen (27) extending through the entire length of the perforator (22). As described in more detail below, the distal tip (24) is generally configured to penetrate tissue of a patient. Similarly, as described in more detail below, side opening (26) is generally configured to receive tissue therein so that after the tissue sample is cut by cutter (40), the tissue sample can be collected within side opening (26) and transported proximally through lumen (27).

[0024] The cutter (40) comprises an elongated cannula (42) defining an internal lumen (48), a distal end (44), and a crimped portion (50) proximate the distal end (44). The distal end (44) includes a generally sharpened, tapered edge (46) to aid in cutting tissue. The tapered edge (46) is oriented obliquely relative to the longitudinal axis of the cannula (42). In this embodiment, the tapered edge (46) is oriented such that its leading edge is disposed at an upper portion of the cannula (42) and its trailing edge is oriented toward a lower portion of the cannula (42). This corresponds to the leading edge of the tapered edge (46) being aligned with the side opening (26) of the perforator (22), as best seen in Figures 3 and 4. In some embodiments, this positioning of the leading edge of the tapered edge (46) can aid in cutting tissue.

[0025] The crimped portion (50) is generally defined by a taper or narrowing of the diameter of the cannula (42) just proximal to the distal end (44). As best seen in FIG. 5, the crimped portion (50) is formed by a continuous change in the diameter of the cannula (42) as it extends distally. As shown, the region of the cannula (42) proximal to the crimped portion (50) defines an inner diameter that is generally larger than the outer diameter of the cannula (28) of the perforator (22). The difference between the inner diameter of the cannula (42) and the outer diameter of the cannula (28) forms a gap (52) between the cannula (42) and the cannula (28). This gap (52) extends proximally from the crimped portion (50) along the entire length of the cannula (42).

[0026] As described in more detail below, gap 52 is generally configured to communicate atmospheric air through cannula 42 to aid in the transfer of the tissue sample through perforator 22. It should be understood, therefore, that the specific dimensions of gap 52 may depend on a variety of factors, such as the size of the collected tissue sample, the pressure of the vacuum used to transfer the tissue sample, the speed of transfer, and / or other factors. It should be understood, therefore, that the difference between the inner diameter of cannula 42 and the outer diameter of cannula 28 may similarly vary due to similar factors.

[0027] As shown in FIG. 5 , crimped portion 50 substantially eliminates gap 52 by reducing the diameter of cannula 42. In particular, at the beginning of crimped portion 50, the diameter of cannula 42 is equal to the outer diameter of cannula 28 plus the amount of diameter desired to create gap 52. As cannula 42 continues to extend distally across crimped portion 50, the diameter of cannula 42 continuously decreases. In this embodiment, crimped portion 50 involves the inner diameter of cannula 42 being reduced to a diameter approximately equal to the outer diameter of cannula 28 of perforator 22. Thus, at the distal end of crimped portion 50, gap 52 is substantially eliminated by direct contact between the inner diameter of cannula 42 and the outer diameter of cannula 28. It should be understood that the particular fit between cannula 42 and cannula 28 at its distal end 44 may vary in view of a variety of factors. For example, in some embodiments, the fit may be tight enough to substantially seal gap 52 against distal end 44 while still allowing cannula 42 to translate relative to cannula 28. In some embodiments, this fit may be desirable to prevent atmospheric air from leaking through gap 52 to the patient. Of course, a variety of alternative fits may be used, as would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0028] Hereafter, the present application describes specific means and techniques for advancing and retracting the needle assembly 20 within the core needle biopsy device 10. At this stage, applicants wish to point out that while they describe specific techniques and means for advancing and retracting the needle assembly 20, they do not intend to be bound thereby and believe that there are many alternative techniques for advancing and retracting the needle assembly 20 that would be known to one skilled in the art of designing biopsy devices.

[0029] 6 and 7 illustrate various components that may be included within the body 12 to control the operation of the biopsy device 10. As can be seen, the body 12 includes one or more batteries 210, vacuum pumps 220, motors 230, 240, and drive assembly 100. In this embodiment, the battery 210, vacuum pump 220, and motors 230, 240 are generally located within the holster housing 14, while the drive assembly 100 is located within the probe housing 16. It should be understood, therefore, that the battery 210, vacuum pump 220, and motors 230, 240 are typically configured to be reusable, while the drive assembly 100 is typically configured to be disposable. It should further be understood that, with all of these components disposed within body 12, biopsy device 10 may be configured as a self-contained, tetherless biopsy device, and that in other embodiments, various components may be located remotely relative to body 12. For example, in some embodiments, a tethered power source may be selected, eliminating battery 210. Similarly, an external vacuum source may be selected, eliminating vacuum pump 220. Similarly, a remote power source in communication with body 12 via a rotary drive cable may be selected, eliminating motors 230, 240. Of course, various alternative configurations will be apparent to those skilled in the art in light of the teachings herein.

[0030] 7 and 8 illustrate the motors (230, 240) in more detail below. As will be appreciated, the motors (230, 240) are generally configured to translate at least a portion of the drive assembly (100) and cock or otherwise prepare the cutter (40) and perforator (22) for firing. As shown, the motors (230, 240) include a cutter motor (230) and a perforator motor (240). The cutter motor (230) is generally configured to translate a portion of the drive assembly (100), thereby translating the cutter (40). Specifically, the cutter motor (230) is coupled to a bevel gear (232) configured to mesh with a combination gear (234). The combination gear (234) includes both a bevel gear portion (236) and a spur gear portion (238). As described in further detail below, bevel gear (234) is configured to be driven by cutter motor (230) to rotate combination gear (234), which in turn is configured to mesh with at least a portion of drive assembly (100) to drive a rack or similar device to translate cutter (40) from a fired position to a cocked position.

[0031] The perforator motor 240 is configured to generally translate a portion of the drive assembly, thereby translating the perforator 22. Specifically, the perforator motor 240 is coupled to a bevel gear 242 configured to mesh with a set gear 244. The set gear 244 includes both a bevel gear portion 246 and a spur gear portion 248. As described in further detail below, the bevel gear 244 is configured to be driven by the perforator motor 240 to rotate the set gear 244. The set gear 244 is then configured to mesh with at least a portion of the drive assembly 100 to drive a rack or similar device to translate the perforator 22 from a fired position to a cocked position.

[0032] The drive assembly (100) includes a cutter drive (110) and a perforator drive (150). As best seen in FIG. 9, the cutter drive (110) includes a manipulator (112), a cutter driver (130), and a coil spring (148). As described in further detail below, the manipulator (112) is generally configured to manipulate the cutter driver (130) to a cocked position, while the coil spring (148) is generally configured to distally fire the cutter (40) via the cutter driver (130). The manipulator (112) defines a hollow interior (114) and includes an upper channel (116), a lower channel (118), and a rack (120). The hollow interior (114) is configured to receive the cutter (40) and cutter driver (130) in combination.

[0033] The upper and lower channels (116, 118) are configured to allow at least a portion of the cutter driver (130) to extend outside the outer diameter defined by the manipulator (112). In this embodiment, only the lower channel (118) is used in this manner. However, the presence of the upper channel (116) makes the manipulator (112) generally symmetrical, allowing the manipulator (112) to be used in other positions. For example, in some embodiments, the manipulator (112) can be positioned so that the rack (120) faces toward the inside of the page rather than the outside of the page in FIG. 9. Of course, this configuration allows the manipulator (112) to be used interchangeably with corresponding components of the perforator driver (150).

[0034] Rack 120 is configured to mesh with spur gear portion 238 of combination gear 234. As described in more detail below, this configuration allows cutter motor 230 to rotate and drive linear movement of manipulator 112. In some circumstances, this linear movement of manipulator 112 can be used to manipulate cutter driver 130, along with cutter 40, into a cocked position where coil spring 148 is loaded to fire cutter 40.

[0035] The cutter driver (130) includes a cylindrical body (132) defining a cutter bore (134) and a catch post (136) extending downwardly from the cylindrical body (132). The cylindrical body (132) is sized to generally correspond to the diameter of the coil spring (148). This relationship between the size of the cylindrical body (132) and the size of the coil spring (148) enables the coil spring (148) to transfer energy to the cylindrical body (132), thereby driving the fire of the cutter (40).

[0036] The cutter bore (134) is sized to receive the cutter (40) therein. When the cutter driver (110) is fully assembled, the cutter bore (134) is coaxial with the cutter (40). Furthermore, the cylindrical body (132) is typically fixedly attached to the cutter (40). In some embodiments, the cutter bore (134) is sized to have an interference fit with the cannula (42) of the cutter (40) to secure the cylindrical body (132) to the cutter (40). In other embodiments, the diameter of the cutter bore (134) is somewhat larger than the outer diameter of the cannula (42) of the cutter (40). In such embodiments, the cylindrical body (132) may be secured to the cutter (40) by a tight fit, such as by a seal. In still other embodiments, the cylindrical body (132) may be overmolded directly onto the surface of the cannula (42) to secure the cylindrical body (132) to the cutter (40). Of course, other suitable methods of joining cylindrical body (132) to cutter (40) may be used, as will be apparent to those skilled in the art in light of the teachings herein.

[0037] A catch post (136) extends downwardly from the cylindrical body (132). As described in more detail below, the catch post (136) is generally configured to retain the cylindrical body (132) against the resilient bias of the spring (148). The catch post (136) extends away from the cylindrical body (132) a sufficient distance so that the catch post (136) protrudes from the lower channel (118) of the manipulator (112). As described in more detail below, this extension allows at least a portion of the probe housing (16) to engage the catch post (136), thereby maintaining the cylindrical body (132) in the cocked position against the resilient bias of the coil spring (148).

[0038] As best seen in FIG. 10 , the perforator drive (150) includes a manipulator (152), a perforator driver (180), and a coil spring (198). As described in further detail below, the manipulator (152) is generally configured to manipulate the perforator driver (180) to a cocked position, while the coil spring (198) is generally configured to distally fire the perforators (22) via the perforator driver (180). The manipulator (152) defines a hollow interior (154) and includes an upper channel (156), a lower channel (158), and a rack (160). The hollow interior (154) is configured to receive the perforator (22) and perforator driver (180) in combination.

[0039] The upper and lower channels 156, 158 are configured to allow at least a portion of the perforator driver 180 to extend outside the outer diameter defined by the manipulator 152. In this embodiment, only the lower channel 158 is used in this manner. However, the presence of the upper channel 156 makes the manipulator 152 generally symmetrical, allowing the manipulator 152 to be used in other positions. For example, in some embodiments, the manipulator 152 can be positioned so that the rack 160 faces away from the page, rather than towards the inside of the page in FIG. 10 . Of course, this configuration allows the manipulator 152 to be used interchangeably with the manipulator 112 described above.

[0040] The rack 160 is configured to mesh with the spur gear portion 248 of the combination gear 244. As explained in more detail below, this configuration allows the perforator motor 240 to rotate and drive the linear movement of the manipulator 152. In some circumstances, this linear movement of the manipulator 152 can be used to manipulate the perforator driver 180, along with the perforators 22, to a cocked position where the coil spring 198 is loaded to fire the perforators 22.

[0041] The perforator driver (180) includes a cylindrical body (182) defining a perforator bore (184) and a catch post (186) extending downwardly from the cylindrical body (182). The cylindrical body (182) is sized to generally correspond to the diameter of the coil spring (198). This relationship between the size of the cylindrical body (182) and the size of the coil spring (198) enables the coil spring (198) to transfer energy to the cylindrical body (182), thereby driving the fire of the perforator (22).

[0042] The perforator bore 184 is sized to receive the perforator 22 therein. When the perforator drive 150 is fully assembled, the perforator bore 184 is coaxial with the perforator 22. Furthermore, the cylindrical body 182 is typically fixedly attached to the perforator 22. In some embodiments, the perforator bore 184 is sized to have an interference fit with the cannula 28 of the perforator 22 to secure the cylindrical body 182 to the perforator 22. In other embodiments, the diameter of the perforator bore 184 is somewhat larger than the outer diameter of the cannula 28 of the perforator 22. In such embodiments, the cylindrical body 182 may be secured to the perforator 22, such as by a tight fit. In yet another embodiment, cylindrical body 182 may be overmolded directly onto the surface of cannula 28 to secure cylindrical body 182 to perforator 22. Of course, other suitable methods of joining cylindrical body 182 to perforator 22 may be used, as will be apparent to those skilled in the art in light of the teachings herein.

[0043] A catch post (186) extends downwardly from the cylindrical body (182). As described in more detail below, the catch post (186) is generally configured to retain the cylindrical body (182) against the resilient bias of the spring (198). The catch post (186) extends away from the cylindrical body (182) a sufficient distance so that the catch post (186) protrudes from the lower channel (158) of the manipulator (152). As described in more detail below, this extension allows at least a portion of the probe housing (16) to engage the catch post (186), thereby maintaining the cylindrical body (182) in the cocked position against the resilient bias of the coil spring (198).

[0044] 11A-12C illustrate an exemplary use of the biopsy device 10 to collect one or more tissue samples from a patient using a single insertion of the needle assembly 20. In particular, FIGS. 11A-11E detail the internal workings of the biopsy device 10. As best seen in FIG. 11A, the biopsy device 10 is initially in a fired or initial position. In this position, both the perforator 22 and the cutter 40 are positioned in their distal-most positions, corresponding to the positions of the perforator 22 and the cutter 40 after firing. When the perforator 22 and the cutter 40 are both in the fired or initial position, the manipulators 112, 152, the perforator driver 180, and the cutter driver 130 are all in their distal-most positions. The coil springs 148, 198 are also in their uncompressed positions.

[0045] In preparation for inserting the needle assembly 20 into a patient, it may be desirable to first cock the needle assembly 20 to enable firing of the needle assembly 20 into a suspected lesion. To cock the needle assembly 20, both the cutter motor 230 and the perforator motor 240 are activated, thereby rotating the bevel gears 232, 242. The rotation of the bevel gears 232, 242 in turn causes rotation of the mating gears 234, 244. The spur gear portions 238, 248 of each mating gear 234, 244 mesh with their respective racks 120, 160, causing translation of each manipulator 112, 152. Thus, the manipulators 112, 152 are translated proximally by the motors 230, 240 from the position shown in FIG. 11A to the position shown in FIG. 11B.

[0046] As the manipulators 112, 152 are translated proximally, the cutter driver 130 and the perforator driver 150 are likewise translated proximally due to contact between their respective catch posts 136, 186 and the distal ends of their respective lower channels 118, 158. The proximal translation of the cutter driver 130 and the perforator driver 150 compresses each of the coil springs 148, 198 in proportion to the translation. Although not shown, it should be understood that in this embodiment, the interior of the probe housing 16 may include stops or other geometric features to provide a mechanical ground at the proximal end of each of the coil springs 148, 198 to enable compression of each of the coil springs 148, 198.

[0047] When the drive assembly 100 is positioned as shown in FIG. 11B, a portion of the probe housing 16 is secured to the cutter driver 130 and the perforator driver 180. Specifically, in this embodiment, the probe housing 16 is shown having resiliently biased latches 17, 18. For example, the distal latch 17 is configured to selectively engage with a catch post 136 on the cutter driver 130 to selectively retain the cutter driver 130 in a cocked position. Similarly, the proximal latch 18 is configured to selectively engage with a catch post 186 on the perforator driver 180 to selectively retain the perforator driver 180 in a cocked position. Each latch 17, 18 in this embodiment is integral with the probe housing 16 and includes a tooth projecting from a resilient arm. Thus, each latch (17, 18) is generally movable and capable of bending into and out of engagement with the cutter driver (130) and perforator driver (180), respectively.

[0048] While the probe housing 16 in this embodiment includes latches 17 and 18, it should be understood that in other embodiments, the same functionality may be achieved in a variety of ways. For example, in some embodiments, the latches 17 and 18 may be replaced with solenoids or other electromechanical devices to selectively hold the cutter driver 130 and the perforator driver 180 in a cocked position. In other embodiments, the latches 17 and 18 may be in the form of other alternative configurations, both integral with the probe body 16, or configured as separate components. In all such alternative embodiments, it should be understood that the latches 17 and 18, or any other actuators, may be connected to one another to facilitate firing the cutter 40 and perforator 22 in a predetermined sequence. Of course, other alternative configurations will be apparent to those skilled in the art in light of the teachings herein.

[0049] When the drive assembly 100 is cocked, as shown in FIG. 11B, potential energy is stored in the coil springs 148, 198, and thus both the cutter 40 and the perforator 22 are ready to fire distally upon release of the potential energy stored in the coil springs 148, 198. To release this potential energy, the latches 17, 18 can be actuated to release the cutter driver 130 and the perforator driver 180. However, it may be preferable to advance the manipulators 112, 152 before releasing the cutter driver 130 and the perforator driver 180. For example, in the position shown in FIG. 11B, the manipulators 112, 152 are positioned proximally after driving the cutter driver 130 and the perforator driver 180 proximally. In some applications, it may be preferable to advance the manipulators (112, 152) distally before firing to avoid the possibility that the manipulators (112, 152) may interfere with the firing of the cutter (40) and perforator (22). To advance the manipulators (112, 152) distally, the rotation of the cutter motor (230) and perforator motor (240) is reversed until the manipulators (112, 152) are positioned as shown in FIG. 11C.

[0050] Once the manipulators (112, 152) are positioned as shown in FIG. 11C, the drive assembly (100) is prepared for firing. In this method of use, the perforator (22) is fired first to penetrate the suspected lesion. The perforator (22) is fired by actuating the proximal latch (18), as shown in FIG. 11D. Actuation of the proximal latch (18) disengages the proximal latch (18) from the catch post (186) of the perforator driver (180). Once the catch post (186) is released, the perforator driver (180) is free to translate distally using energy provided by the coil spring (198). Because the perforator driver (180) is rigidly attached to the perforator (22), the perforator (22) translates distally as well.

[0051] The firing of the perforator (22) as a result of the actuator shown in Figure 11D can be understood by comparing Figures 12A and 12B. As can be seen, the perforator (22) is initially positioned immediately in front of the suspected lesion (SL), as shown in Figure 12A. Upon firing of the perforator (22) as described above, the perforator (22) advances distally within the suspected lesion (SL), as shown in Figure 12B. It should be appreciated that this movement of the perforator (22) results in minimal displacement of the suspected lesion (SL), thereby avoiding movement of the suspected lesion (SL) and improving the quality of any tissue sample collected.

[0052] After the perforator 22 is fired into the suspected lesion SL, it may be desirable to obtain a tissue sample by advancing the cutter 40 relative to the perforator 22. Specifically, as the perforator 22 is fired into the suspected lesion SL, tissue may prolapse into the side opening 26 of the perforator 22. In some applications, tissue prolapse into the side opening 26 may occur via internal tension within the tissue. In other applications, a vacuum may be applied to the lumen 27 of the perforator 22 to provide a force that facilitates tissue prolapse into the side opening 26.

[0053] Once the tissue has escaped through the side opening (26) of the perforator (22), the cutter (40) can be used to sever the tissue sample. Specifically, the cutter (40) can be fired by first actuating the distal latch (17), as shown in FIG. 11E. Actuating the distal latch (17) disengages the catch post (136) of the cutter driver (130). Disengagement of the catch post (136) allows the cutter driver (130) to freely translate distally. Thus, once the catch post (136) is disengaged, the cutter driver (130) is fired distally by the energy provided by the coil spring (148). Because the cutter driver (130) is rigidly attached to the cutter (40), the cutter (40) is similarly fired distally to the position shown in FIGS. 11E and 12C.

[0054] The firing of cutter (40) resulting from the actuation shown in Figure 11E can be understood by comparing Figures 12B and 12C. As can be seen, cutter (40) is initially positioned near the suspected lesion (SL) immediately prior to firing, as shown in Figure 12B. As cutter (40) is fired, distal tip (44) is translated distally past side opening (26) of perforator (22), as shown in Figure 12C. As distal tip (44) passes through side opening (26), the tissue sample is severed.

[0055] Next, it may be desirable to transfer the severed tissue sample through the lumen (27) of the perforator (22) to the tissue sample holder (80). To transfer the severed tissue sample, a vacuum is applied to the lumen (27) of the perforator (22). Such vacuum may be applied via the tissue sample holder (80) to pack the severed tissue sample into the tissue sample holder (80). When the vacuum is applied, a proximal force is applied to the proximal end of the severed tissue sample. If the proximal force is large enough, the severed tissue sample begins to move proximally through the lumen (27) of the perforator (22). However, the movement of the severed tissue sample may create a negative pressure at the distal end of the severed tissue sample. Therefore, it may also be desirable to provide either atmospheric air pressure or back pressure to the distal end of the severed tissue sample. In this embodiment, such atmospheric air pressure or back pressure is provided by the gap (52) defined by the cutter (40). In this embodiment, atmospheric air is continuously supplied through lumen 48 via the proximal end of cutter 40, although it should be understood that in other embodiments, the supply of atmospheric air may be regulated using a valve or other fluid control mechanism.

[0056] It should be understood that while atmospheric air is continuously supplied to cutter 40, atmospheric air is selectively supplied by cutter 40 only to perforator 22. For example, after a tissue sample is severed, gap 52 of cutter 40 is positioned such that gap 52 is in fluid communication with side opening 26. Thus, atmospheric air can freely flow from cutter 40 to perforator 22. However, when distal end 44 of cutter 40 is positioned proximal to side opening 26, side opening 26 is not in fluid communication with gap 52, and the flow of atmospheric air to side opening 26 is stopped.

[0057] Once the severed tissue sample has been transferred to tissue sample holder 80, it may be desired to collect one or more additional tissue samples. To collect additional tissue samples, both cutter 40 and perforator 22 are retracted using motors 230, 240. This retraction also cocks both cutter 40 and perforator 22, so that the same tissue sample collection process described above can be repeated until the desired number of tissue samples have been collected or tissue sample holder 80 is filled.

[0058] Exemplary Combinations The following examples illustrate 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 any subsequent application thereto. No disclaimer is intended. The following examples are presented merely for illustrative purposes. 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 particular components referred to in the following examples. Accordingly, none of the aspects or features referred to below should be considered critical unless specifically and expressly indicated otherwise by the inventor or by the intended inventor's successors. If any claims are presented in this application or any subsequent application related thereto that include additional features other than those referred to below, these additional features should not be presumed to have been added for any reason related to patentability. Example 1 1. A core needle biopsy device comprising: a needle assembly having a hollow perforator disposed within a hollow cutter, the cutter having a distal tip and a crimped portion proximate the distal tip; and a drive assembly configured to selectively cock and fire the perforator and the cutter.

[0059] Example 2 2. The core needle biopsy device of Example 1, wherein the crimped portion is tapered proximal to the distal tip of the cutter to form a gap between the perforator and the cutter.

[0060] Example 3 3. The core needle biopsy device of Example 2, wherein the perforator has a sharpened tip and a side opening proximate to the sharpened tip, and the gap defined by the crimped portion of the cutter is configured to supply atmospheric air to the side opening of the perforator when the distal tip is positioned proximal to the side opening.

[0061] Example 4 4. The core needle biopsy device of any one or more of Examples 1-3, wherein the distal tip of the cutter forms a tapered edge configured to cut tissue.

[0062] Example 5 5. The core needle biopsy device of example 4, wherein the tapered edge of the cutter is oriented at an oblique angle relative to a longitudinal axis defined by the cutter.

[0063] Example 6 6. The core needle biopsy device of any one or more of Examples 1 to 5, wherein the perforator is configured to transfer a tissue sample through a lumen defined by the perforator to a tissue sample holder coupled to the core needle biopsy device.

[0064] Example 7 7. The core needle biopsy device of any one or more of Examples 1 to 6, wherein the drive assembly includes a cutter drive and a perforator drive, the cutter drive configured to cock and fire the cutter, and the perforator drive configured to cock and fire the perforator.

[0065] Example 8 8. The core needle biopsy device of example 7, wherein the cutter driver and the perforator driver are operable independently of each other to cock and fire the cutter and perforator, respectively.

[0066] Example 9 8. The core needle biopsy device of Example 7, wherein the cutter drive unit and the perforator drive unit each include a manipulator, a driver, and a spring, and the manipulator is movable relative to a fixed portion of the spring to move the driver to a cocked position.

[0067] Example 10 10. The core needle biopsy device of example 9, wherein each manipulator includes a rack, the rack being configured to be driven by a motor to translate each manipulator proximally and distally.

[0068] Example 11 1. A needle assembly for use in a biopsy device, comprising: a hollow perforator having a sharp tip configured to penetrate tissue and a side opening; and a cutter arranged coaxially around the perforator, the cutter having a distal cutting edge and a crimped portion adjacent to the distal cutting edge.

[0069] Example 12 12. The needle assembly of claim 11, wherein the crimped portion of the cutter is defined by a taper in diameter of the cutter, the crimped portion tapering inward as the cutter extends distally toward a cutting edge of the distal portion.

[0070] Example 13 13. The needle assembly of any one or more of Examples 11-12, wherein the perforator defines a lumen extending from the side opening to a proximal end of the perforator.

[0071] Example 14 14. The needle assembly of claim 13, wherein the lumen is configured to conduct a tissue sample from the side opening to a tissue sample holder in communication with the proximal end of the perforator.

[0072] Example 15 15. The needle assembly of any one or more of Examples 11-14, wherein the crimped portion defines a gap between the interior of the cutter and the exterior of the perforator, the gap extending from the crimped portion to the proximal end of the cutter.

[0073] Example 16 16. The needle assembly of claim 15, wherein the gap defined by the crimped portion is configured to communicate fluid from the proximal end of the cutter to the side opening of the perforator.

[0074] Example 17 17. The needle assembly of claim 16, wherein the proximal end of the cutter is in open fluid communication with atmospheric air.

[0075] Example 18 17. The needle assembly of claim 16, wherein the proximal end of the cutter is in selective fluid communication with atmospheric air.

[0076] Example 19 17. The needle assembly of claim 16, wherein the cutter is movable relative to the perforator such that the cutter is configured to utilize the gap defined by the crimped portion to provide selective fluid communication to the side opening of the perforator.

[0077] Example 20 17. The needle assembly of claim 16, wherein the cutting edge of the distal portion of the cutter is configured to fluidly isolate the exterior of the perforator relative to the gap defined by the crimped portion.

[0078] Example 21 1. A method of using a core needle biopsy device to collect multiple tissue samples with a single insertion of a needle assembly, the needle assembly including a perforator and a cutter coaxially disposed around the perforator, the method comprising: inserting the needle assembly into a patient to position a distal tip of the perforator adjacent to a suspicious lesion; firing the perforator distally to position a lateral opening of the perforator within at least a portion of the suspicious lesion; firing the cutter distally to sever a tissue sample at the lateral opening of the perforator; and transporting the tissue sample proximally through a lumen defined by the perforator using a vacuum applied to a proximal end of the tissue sample.

[0079] Example 22 22. The method of example 21, wherein the step of firing the cutter includes advancing a cutting edge of the cutter distally beyond the side opening of the perforator.

[0080] Example 23 23. The method of any one or more of Examples 21-22, further comprising retracting the cutter relative to the perforator after transferring the tissue sample in preparation for collecting another tissue sample.

[0081] Example 24 24. The method of example 23, wherein the steps of inserting the needle assembly, firing the cutter distally, transporting the tissue sample, and retracting the cutter to collect multiple tissue samples are repeated while the perforator remains within the patient.

[0082] While various embodiments of the present invention have been shown and described, further modifications of the methods and systems described herein may be achieved by those skilled in the art through appropriate modifications without departing from the scope of the present invention. While some of such possible 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. previously discussed are illustrative and not required. Accordingly, it will be understood that the scope of the present invention should be considered in terms of the following claims, and not limited to the details of construction and operation shown and described in the specification and drawings.

[0083] 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.

[0084] Any patent, publication, or other disclosure material that is said to be incorporated herein by reference, in whole or in part, should be understood to be incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated herein by reference but that contradicts existing definitions, descriptions, 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.

[0085] [Embodiment] (1) (a) a main body; (b) a needle assembly extending distally from the body and having a hollow perforator and a hollow cutter, the perforator being disposed within the cutter, the cutter having a distal tip and a crimped portion proximate the distal tip; (b) a drive assembly configured to selectively cock and fire the perforator and the cutter relative to the body; and A core needle biopsy device comprising: (2) The core needle biopsy device of claim 1, wherein the crimped portion is tapered proximal to the distal tip of the cutter to form a gap between the perforator and the cutter. (3) The core needle biopsy device of embodiment 2, wherein the perforator has a sharp tip and a side opening proximal to the sharp tip, and the gap defined by the crimped portion of the cutter is configured to supply atmospheric air to the side opening of the perforator when the distal tip is positioned proximal to the side opening. (4) The core needle biopsy device of embodiment 3, wherein the distal tip of the cutter is configured to fluidly isolate the exterior of the perforator relative to the gap defined by the crimped portion. (5) The core needle biopsy device of embodiment 1, wherein the distal tip of the cutter forms a tapered edge configured to cut tissue.

[0086] (6) The core needle biopsy device of embodiment 5, wherein the tapered edge of the cutter is oriented at an oblique angle relative to a longitudinal axis defined by the cutter. (7) The core needle biopsy device of embodiment 1, wherein the perforator is configured to transfer a tissue sample through a lumen defined by the perforator to a tissue sample holder coupled to the core needle biopsy device. (8) The core needle biopsy device of embodiment 1, wherein the drive assembly includes a cutter drive and a perforator drive, the cutter drive configured to cock and fire the cutter, and the perforator drive configured to cock and fire the perforator. (9) The core needle biopsy device of embodiment 8, wherein the cutter driver and the perforator driver are operable independently of each other to cock and fire the cutter and the perforator, respectively. (10) A core needle biopsy device as described in embodiment 8, wherein the cutter drive unit and the perforator drive unit each include a manipulator, a driver, and a spring, and the manipulator is movable relative to a fixed portion of the spring to move the driver to a cocked position.

[0087] (11) A core needle biopsy device as described in embodiment 10, wherein each manipulator includes a rack, and the rack is configured to be driven by a motor to translate each manipulator proximally and distally. (12) The core needle biopsy device of embodiment 8, wherein the cutter driver is directed distal to the perforator driver. (13) The core needle biopsy device of embodiment 8, wherein the cutter, the perforator, the cutter driver, and the perforator driver are all oriented coaxially with respect to one another. (14) The core needle biopsy device of embodiment 8, wherein at least a portion of the cutter driver defines an open proximal end, the open proximal end configured to allow the perforator to extend proximally beyond the cutter driver. (15) The core needle biopsy device of embodiment 1, wherein the distal tip of the cutter is oriented at an angle defined by the longitudinal axis of the cutter.

[0088] (16) A needle assembly for use in a biopsy device, comprising: (a) a hollow perforator having a sharp tip configured to penetrate tissue and a side opening; (b) a cutter disposed coaxially around the perforator, the cutter having a distal cutting edge and a crimped portion adjacent the distal cutting edge; The needle assembly comprising: (17) The needle assembly of claim 16, wherein the crimped portion of the cutter is defined by a taper in the diameter of the cutter, the crimped portion tapering inward as the cutter extends distally toward a cutting edge of the distal portion. 18. The needle assembly of claim 16, wherein the perforator defines a lumen extending from the side opening to a proximal end of the perforator. (19) The needle assembly of claim 18, wherein the lumen is configured to conduct a tissue sample from the side opening to a tissue sample holder in communication with the proximal end of the perforator. (20) A method of using a core needle biopsy device to collect multiple tissue samples with a single insertion of a needle assembly, the needle assembly including a perforator and a cutter coaxially disposed about the perforator, the method comprising: (a) inserting the needle assembly into a patient to position the distal tip of the perforator adjacent a suspected lesion; (b) firing the perforator distally to position a lateral opening of the perforator within at least a portion of the suspected lesion; (c) firing the cutter distally to sever a tissue sample into the side opening of the perforator; (d) transporting the tissue sample proximally through a lumen defined by the perforator using a vacuum applied to the proximal end of the tissue sample; The method comprising:

Claims

1. 1. A core needle biopsy device comprising: (a) a main body; (b) a needle assembly extending distally from the body, the needle assembly having a perforator and a hollow cutter, the perforator disposed within the hollow cutter, the cutter defining a cutting edge, and the perforator defining a sharp tip configured to penetrate tissue; (c) a drive assembly having a cutter drive and a perforator drive, the cutter drive having a first manipulator and the perforator drive having a second manipulator, the first manipulator configured to engage a motor drive mechanism to compress a cutter spring while moving the cutter to a cocked position, and the second manipulator configured to engage the motor drive mechanism to compress a perforator firing spring while moving the perforator to a cocked position, the drive assembly configured to move the cutter and the perforator independently of one another, the first manipulator, the cutter spring, the second manipulator, and the perforator firing spring being coaxially arranged with one another.

2. 2. The core needle biopsy device of claim 1, wherein the drive assembly further includes a cutter driver and a perforator driver, the cutter driver being secured to the cutter and configured to drive the cutter from the cocked position to the fired position, and the perforator driver being secured to the perforator and configured to drive the perforator from the cocked position to the fired position.

3. 3. The core needle biopsy device of claim 2, wherein the cutter driver is configured to move relative to the first manipulator and the perforator driver is configured to move relative to the second manipulator.

4. 3. The core needle biopsy device of claim 2, further comprising a latch assembly, the latch assembly having a first latch and a second latch, the first latch configured to engage with the cutter driver to selectively release movement of the cutter driver, and the second latch configured to engage with the perforator driver to selectively release movement of the perforator driver.

5. The core needle biopsy device of claim 4 , wherein the first latch and the second latch each have a tooth and a flexible arm, each tooth extending outwardly from a respective flexible arm.

6. The core needle biopsy device of claim 4 , wherein the first latch and the second latch are each integral with the body.

7. The core needle biopsy device of claim 4 , wherein the first latch connects with the second latch to release the cutter driver and the perforator driver in a predetermined sequence.

8. The core needle biopsy device of claim 1 , wherein the drive assembly includes one or more gears in communication with the motor drive mechanism, the first manipulator, and the second manipulator.

9. 2. The core needle biopsy device of claim 1, wherein the drive assembly further comprises a first gear and a second gear, the first gear communicating with the motor drive mechanism to move the first manipulator, and the second gear communicating with the motor drive mechanism to move the second manipulator.

10. 2. The core needle biopsy device of claim 1, wherein the drive assembly further comprises a first gear and a second gear, the first manipulator having a first rack, and the second manipulator having a second rack, the first gear communicating with the motor drive mechanism to move the first manipulator through engagement with the first rack, and the second gear communicating with the motor drive mechanism to move the second manipulator through engagement with the second rack.

11. The core needle biopsy device of claim 1 , wherein the motor drive mechanism comprises a pair of motors.

12. 10. The core needle biopsy device of claim 1, wherein the perforator defines a hollow interior, the hollow interior of the perforator allowing a tissue sample to be transferred through the perforator and into a tissue sample holder.

13. 10. The core needle biopsy device of claim 1, wherein the cutter has a distal end and a crimped portion proximate the distal end, the crimped portion tapering proximal to the distal end of the cutter to form a gap between the perforator and the cutter.

14. 14. The core needle biopsy device of claim 13, wherein the perforator defines a hollow interior, the hollow interior of the perforator being configured to transfer a tissue sample through the perforator and into a tissue sample holder, and the gap being configured to supply atmospheric air to a portion of the perforator.

15. A core needle biopsy device as described in claim 1, wherein the first manipulator having the cutter spring therein and the second manipulator having the perforator firing spring therein are arranged coaxially with the needle assembly.

16. A core needle biopsy device as described in claim 2, wherein the cutter driver is disposed within the first manipulator and the perforator driver is disposed within the second manipulator.

17. A core needle biopsy device as described in claim 11, wherein the axial direction of the rotation shaft of the motor is along the axial direction of the needle assembly.

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