Biopsy system with end-deploying needle

Abstract

A needle for use with a biopsy device includes an outer cannula and a tissue-piercing tip. The outer cannula defines a cutter lumen for receiving a cutter therein and a lateral lumen adjacent to the cutter lumen. The tissue-piercing tip has a body, a marker opening, and a marker lumen. The body defines a plurality of cutting surfaces. The marker opening is disposed in at least one cutting surface of the plurality of cutting surfaces. The marker lumen extends distally through the body from the marker opening to a proximal opening. The proximal opening communicates with the cutter lumen.

Description

[Technical field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 62 / 777,390, entitled “Biopsy System with End Deploy Needle,” filed December 10, 2018, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Many patients undergo breast biopsy due to irregular mammograms and palpable abnormalities. Biopsies may include surgical excision biopsies, as well as stereotactic and ultrasound-guided breast needle biopsies. With image-guided biopsies, a radiologist or other physician may take a small sample of the irregular tissue for laboratory analysis. If the biopsy proves malignant, additional surgery (e.g., lumpectomy or mastectomy) may be required. With needle biopsies, the patient may return to the radiologist after a day or more and the biopsy site (site of the lesion) may need to be repositioned in preparation for surgery. Imaging systems such as ultrasound, magnetic resonance imaging (MRI), or x-rays may be used to locate the biopsy site. A marker may be placed at the time of biopsy to aid in repositioning the biopsy site.

[0003] The use of markers used after breast biopsy to mark the location where the biopsied tissue has been removed is described in the following U.S. patents: U.S. Patent No. 6,083,524, issued July 4, 2000, entitled "Polymerizable biodegradable polymers including carbonate or dioxanone linkages"; U.S. Patent No. 6,162,241, issued December 4, 2000, entitled "Hemostatic tissue sealants"; U.S. Patent No. 6,270,464, issued August 7, 2001, entitled "Biopsy localization method and device"; U.S. Patent No. 6,356,782, issued March 12, 2002, entitled "Subcutaneous cavity marking device and method"; and U.S. Patent No. 6,605,294, issued August 12, 2003, entitled "Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissues or No. 8,600,481, issued December 3, 2013, entitled "Subcutaneous cavity marking device," and U.S. Pat. No. 8,939,910, issued January 27, 2015, entitled "Method for enhancing ultrasound visibility of hyperechoic materials." All of these U.S. patents are incorporated by reference in their entirety.

[0004] In some situations, a biopsy site marker is used to identify the biopsy site after a biopsy procedure. In some embodiments, such a biopsy site marker can be deployed to the biopsy site through a biopsy needle using a side-deploying marker delivery device. In this configuration, the marker delivery device includes a side opening that matches the side opening of the biopsy needle. However, this configuration may not be entirely satisfactory in all situations, but the concept of deployment through the biopsy needle may still be desirable. Thus, in some situations, it may be desirable to deploy a biopsy site marker from an end-deploying marker delivery device with a marker delivery device disposed within the biopsy needle. Although several systems and methods have been made and used to mark a biopsy site, it is believed that no one prior to the present inventors has made or used the invention described in the appended claims.

[0005] While the specification concludes with claims which particularly point out and distinctly claim the invention, 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, as represented by dashed lines. [Brief description of the drawings]

[0006] [Figure 1] 1A-C show exemplary embodiments of biopsy site marker placement according to embodiments of the present disclosure. [Diagram 2] 1 shows a perspective view of an exemplary marker delivery device. [Diagram 3] 3 shows a side cross-sectional view of the marker delivery device of FIG. 2. [Figure 4] 2 shows a cross-sectional view of a marker being deployed from a distal portion of the marker delivery device of FIG. 1 and through a lateral opening in a biopsy needle to mark a biopsy site. [Diagram 5] 1 illustrates a detailed perspective view of an exemplary biopsy needle. [Figure 6] FIG. 6 shows a detailed perspective view of the tissue-piercing tip of the biopsy needle of FIG. 5. [Figure 7] 8 shows a side elevational view of the tissue piercing tip of FIG. 7. [Figure 8] 8 shows a perspective cross-sectional view of the biopsy needle of FIG. 5 taken along line 8-8 of FIG. 5. [Figure 9] 6 shows a perspective view of an exemplary marker delivery device for use with the biopsy needle of FIG. 5. [Figure 10] 10 shows a detailed perspective view of the cannula of the marker delivery device of FIG. [Figure 11] 11 shows a detailed cross-sectional view of the cannula of FIG. 9 taken along line 11-11 of FIG. [Figure 12A] 11 shows a side cross-sectional view of the biopsy needle of FIG. 5 and the cannula of FIG. 10, with the cannula being inserted into the biopsy needle. [Figure 12B] 11 shows another cross-sectional side view of the biopsy needle of FIG. 5 and the cannula of FIG. 10 with the marker delivery device in an intermediate position. [Figure 12C] 11 shows yet another cross-sectional side view of the biopsy needle of FIG. 5 and the cannula of FIG. 10 with the marker delivery device in a deployed position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be practiced in a variety of other ways, including ways 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.

[0008] 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 present invention. As will be understood, the present invention is capable of other various and obvious aspects, all without departing from the present invention. Thus, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0009] It may be beneficial to be able to mark the location or periphery of a lesion before or immediately after removing or sampling the lesion, whether temporary or permanent. Marking before removal can help ensure that the entire lesion has been excised, if desired. Alternatively, if the lesion has been inadvertently removed in its entirety, marking the biopsy site immediately after the procedure will allow for the location to be reconfirmed for future identification.

[0010] Once a marker is placed at the biopsy site, it may be desirable for the marker to remain visible under ultrasound. It may also be desirable for the marker to be easily identifiable relative to other structural features of the patient. For example, it may be desirable for the marker to be distinguishable from microcalcifications under ultrasound visualization to avoid inadvertently characterizing the marker as a microcalcification during a subsequent ultrasound examination. Typically, microcalcifications are used in the field to identify suspicious lesions or masses. Thus, it is generally desirable for the ultrasound view to be distinguishable as a marker and not inadvertently identified as a new mass.

[0011] I. Exemplary Markers The embodiments presented herein relate to an apparatus and procedure for manufacturing a marker for percutaneously marking a biopsy cavity (10) having surrounding tissue (30), as shown in FIGS. 1A-1C. For example, as shown in FIG. 1A, a marker (100) may be initially placed in the biopsy cavity (10) to facilitate repositioning of the biopsy site. The marker (100) may include a carrier (120) and a marker element (12). The carrier (120) generally includes a bioabsorbable marker material (122). Thus, the carrier (120) is generally configured for absorption into the patient after the marker (100) is placed in the biopsy cavity (10). In some embodiments, the carrier (120) may include a plurality of microbubbles to enhance visualization of the carrier (120) under ultrasound. As described in more detail below, the marker material (122) is generally bioabsorbable such that the marker material (122) may be absorbed into the patient's tissue over time. In this example, the marker material 122 comprises a hydrogel that is initially in a dehydrated state. Although a hydrogel is used in this example, it should be understood that in other examples, the marker material 122 may comprise other known bioabsorbable materials.

[0012] In this embodiment, the marker (100) further includes a marker element (12), which is generally not bioabsorbable. The marker element (12) may include a radiopaque or echogenic marker embedded within the bioabsorbable marker material (122) of the carrier (120). For example, the marker element (12) may include metal, hard plastic, or other radiopaque or hyperechoic material known to those of skill in the art in view of the teachings herein. In other embodiments, the marker (100) may be formed without the marker element (12). In yet other embodiments, the marker (100) may be formed with only the marker element (12), such that the carrier (120) is omitted and the marker element (12) is in a "bare" form. In other words, in some embodiments, the marker (100) is formed only from the carrier (120) as a bare clip.

[0013] The marker material (122) is generally expandable when placed in the patient at the biopsy site. As shown in Figures 1B and 1C, the initially dehydrated marker material (122) may absorb fluid from the surrounding tissue (30) into which it is inserted. In response to this fluid absorption, the marker material (122) may expand, thereby allowing the carrier (120) to fill the cavity formed at the biopsy site by the removal of the tissue sample during the biopsy procedure. Bioabsorbable materials may be particularly suitable in applications where it is desired to allow natural tissue growth to completely or partially replace the implanted material over time. Thus, biocompatibility is ensured and the natural mechanical parameters of the tissue are substantially restored to those of the pre-damage state.

[0014] The marker (100) may be inserted into the body either surgically through an opening in the body cavity (30) or through a minimally invasive procedure using a device such as a catheter, introducer, or similar type of insertion device. The marker (100) may be delivered immediately after removal of the tissue specimen using the same device used to remove the tissue specimen itself. Follow-up non-invasive detection techniques, such as x-ray mammography or ultrasound, may then be used by the physician to identify, locate, and monitor over a period of time the biopsy cavity site via the marker (100).

[0015] The marker (100) of this example is large enough to be easily visible to a clinician under, for example, x-ray or ultrasound observation, yet small enough that it can be deployed percutaneously into the biopsy cavity and not cause any problems for the patient. Although the example is described in the context of treating and diagnosing breast tissue, the embodiments presented herein may be used to marker in any internal tissue, such as, for example, breast tissue, lung tissue, prostate tissue, lymph gland tissue, etc.

[0016] Hydration of the marker material (122) of the carrier (120) by the natural moisture of the surrounding tissue causes the polymer to expand, thus minimizing the risk of migration. The growing hydrogel-based marker material (122) centers the marker (100) in the biopsy cavity as it grows. As the hydrogel expands, the naturally present moisture, or hydration, from the surrounding tissue allows for an increase in sound transmission, appearing increasingly hypoechoic and easier to visualize on follow-up ultrasound studies.

[0017] The hydrated hydrogel marker material (122) of the carrier (120) may also be used to fabricate a permanent marker (12). The hypoechoic nature of the hydrated marker material (122) allows for ultrasonic visibility of the permanent marker (12) within the hydrogel hydrated marker material (122) since the permanent marker (12) is contoured as a specular reflector within the hypoechoic hydrated marker having a non-reflective substrate such as water.

[0018] II. Exemplary Marker Delivery Devices In some embodiments, it may be desirable to use a particular marker delivery device to deploy the above-described marker (100) into the body cavity (30). For example, Figures 2 and 3 show an exemplary marker delivery device (150) that includes an elongated outer cannula (162) having a marker exit port, such as a side opening (164), formed adjacent to but spaced proximally from the distal end of the cannula (162).

[0019] A grip (166) may be provided at a proximal end of the cannula (162). A push rod (168) may be provided and extend coaxially within the cannula (162) such that the push rod (168) is configured to translate within the cannula (162) to displace one or more markers through the side opening (164) (see FIG. 3). The rod (168) may have sufficient compressive stiffness to push the markers out of the internal lumen (165) of the cannula (162) through the opening (164) but may be relatively flexible in bending. A plunger (170) is coupled at the proximal end of the rod (168) for urging the rod (168) distally within the cannula (162) to deploy the markers from within the cannula (162).

[0020] A user may grasp grip (166) with two fingers and use the thumb of the same hand to depress plunger (170) such that marker delivery device (160) may be operated with only one hand of the user. A spring (not shown) or other feature may be provided about rod (168) to bias rod (168) proximally relative to grip (166) and cannula (162).

[0021] 3 shows a cross-sectional view of a distal portion of marker delivery device (160). As can be seen, a biopsy marker (300), similar to marker (100) described above, is disposed within the interior lumen (165) of cannula (162). In this example, marker (300) includes a generally cylindrically shaped body, such as collagen, a hydrogel, or the like, and a biocompatible or otherwise absorbable marker material (306), such as a metallic, generally radiopaque, permanent marker or marker element (310) (shown in phantom) disposed within or otherwise carried by the marker material (306).

[0022] Cannula (162) may be formed from any suitable metallic or non-metallic material. In some versions, cannula (162) is formed from a thin-walled hollow tube formed from a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as polyether block amide (PEBA), known under the trade name PEBAX. Cannula (162) may be formed from PEBAX and may be substantially transparent to visible light and x-rays.

[0023] The side opening (164) may be formed by cutting away a portion of the wall of the cannula (162). The side opening (164) communicates with an internal lumen (165) of the cannula (162). The side opening (164) may extend axially (in a direction parallel to the axis of the lumen (165)) from a proximal open end (164A) to a distal open end (164B), as shown in FIG.

[0024] In this embodiment, a distal tip (172) extends from the distal end of the cannula (162) and is rounded, as shown in FIG. 3. Referring to FIG. 3, the distal end of the cannula (162) is closed by a one-piece end piece (171), a portion of which extends into the internal lumen (165) of the cannula (162). The end piece (171) may be a molded or cast component. The end piece (171) includes a tip (172), a ramp (210) having a sloped surface (212), and a marker engaging element (240). The sloped surface (212) serves to move the marker (300) from the internal lumen (165) through the side opening (164). The marker engaging element (240) serves to retain the marker (300) within the internal lumen (165) until a user intends to deploy the marker (300).

[0025] Marker engaging element (240) is disposed within inner lumen (165), with at least a portion of marker engaging element (240) disposed distally from proximal end (164A) of side opening (164). Marker engaging element (240) extends along a portion of the bottom of cannula (162) below opening (164) such that marker engaging element (240) is positioned to reinforce the portion of cannula (162) in which opening (164) is formed. For example, as shown in FIG. 3, by positioning marker engaging element (240) directly below opening (164), element (240) serves to strengthen cannula (162) in the area where the wall of cannula (162) is cut to form opening (164). As shown in FIG. 3, the marker engagement element (240) extends from the proximal-most portion of the inclined surface (212) and does not extend proximally from the side opening (164), although in other embodiments, a portion of the element (240) may extend proximally from the opening (164).

[0026] As shown in Figure 3, marker engaging element (240) is in the form of a step having a generally uniform thickness (T) along the axial length of element (240), except that element (240) has a tapered proximal end (242). Tapered proximal end (242) forms an included angle of approximately 45 degrees with the longitudinal axis of lumen (165) (with the horizontal in Figure 3), while angled surface (212) forms an included angle of approximately 30 degrees with the longitudinal axis. Of course, any number of other suitable angles may be used.

[0027] As shown in FIG. 3, the upwardly facing surface (244) of the marker-engaging element (240) (the surface facing the opening (164)) extends distally to contact the ramp (212) so that there is no space or gap between the surface (244) and the ramp (212). Such an arrangement is advantageous to reduce the possibility of the marker (300) getting caught between the marker-engaging element (240) and the ramp (212) as it moves past the marker-engaging element (240). In some versions, the marker-engaging element (240), the ramp (210), and / or the tip (172) are formed from or include a material that is relatively more radiopaque than the walls of the cannula (162). For example, when the element (240), the ramp (210), and the tip (172) are formed as a unitary end piece (171), the end piece (171) may include a radiopaque additive, such as barium sulfate. For example, the end piece (171) may be a component molded from PEBAX with approximately 20 weight percent barium sulfate added to the molten PEBAX molding material. The relatively more radiopaque marker engaging element (240), ramp (210), and tip (22) may aid in distinguishing the location of those components using radiographic imaging. Also, when the steps of the ramp (210) and / or engaging element (240) are positioned relative to the opening (164), the addition of radiopaque material may aid in identifying the location of the opening (164) and the location of the marker (300) relative to the opening (164) before, during, or after the deployment of the marker (300).

[0028] Referring to FIG. 4, a marker delivery device (160) is used to deploy a marker (300) to mark a biopsy site within a patient. In FIG. 4, a cannula biopsy needle (400) is shown having a closed distal end with a piercing tip (402) and a lateral tissue receiving opening (414). The marker delivery device (160) is introduced to the biopsy site through the biopsy needle (400), which may be the same needle (400) used to collect tissue samples from the biopsy site. The biopsy needle (400) may be of the type used with a single-insertion multiple sample vacuum-assisted biopsy device. Several such biopsy devices are disclosed in various patents and patent applications incorporated by reference herein, although other biopsy devices may also be used.

[0029] FIG. 4 shows the distal end of the marker delivery device (160) disposed within the needle (400). The needle (400) may be disposed within tissue and a biopsy sample may be obtained through the lateral opening (414), thereby providing a biopsy cavity adjacent the lateral opening (414). The marker delivery device (160) is then inserted into the proximal opening of the needle (400) after the tissue sample has been obtained and moved proximally through the needle (400) without removing the needle (400) from the patient's tissue. In FIG. 4, the needle (400) and marker delivery device (160) are disposed such that the opening (164) of the cannula (162) and the lateral opening (414) of the needle (400) are substantially aligned axially and circumferentially. Next, with the marker delivery device (160) and needle (400) so positioned at the biopsy site, the push rod (168) is advanced to deploy the marker (300) up the inclined surface (212) through the opening (164) and then through the lateral opening (414) into the biopsy cavity.

[0030] III. Exemplary Biopsy Systems with End Deployment Capability In some embodiments, it may be desirable to deploy a marker similar to the markers (100, 300) described above in other ways. In particular, in some embodiments, it may be desirable to deploy a marker from a distal end of a marker delivery device similar to the marker delivery device (150) described above. In such embodiments, deployment from a distal end may be desirable for improved ease of use. For example, if a marker is deployed through an opening, such as the side opening (164) described above, such a marker may be subject to high resistance from the opening (164). Furthermore, in some embodiments, a push rod similar to the push rod (168) may be subject to engagement of the opening, which may lead to increased procedure times. In embodiments in which deployment is provided through the distal end of the marker delivery device, these challenges may be eliminated.

[0031] In embodiments where marker deployment is provided through the distal end of a marker delivery device, it may be desirable to incorporate features into the associated device to aid in the configuration of such a marker delivery device. For example, in embodiments where marking is performed through a biopsy needle, it may be desirable to include features in the biopsy needle to more easily facilitate marker deployment through the distal end of the marker delivery device. Although various embodiments of devices suitable for providing marker deployment through the distal end of a marker delivery device are described herein, it should be understood that a variety of alternative configurations may be used as will be apparent to those of skill in the art in view of the teachings herein.

[0032] A. An exemplary biopsy needle with a deployment aperture 5-8 illustrate an exemplary biopsy needle (600) that may be used with the various marker delivery devices described herein. It should be understood that unless otherwise expressly stated herein, the biopsy needle (600) is substantially similar to the biopsy needle (400) described above. The biopsy needle (600) of this example includes an outer cannula (610), a lateral opening (612) formed therein, and a tissue piercing tip (640) secured to a distal end of the outer cannula (610). Although not shown, it should be understood that the proximal end of the outer cannula (610) may be coupled to a distal end of a biopsy device (not shown) to facilitate collection of a tissue sample via the biopsy needle (600).

[0033] The outer cannula (610) includes a cutter receiving tube (620) received within a distal end of the outer cannula (610). The cutter receiving tube (620) defines a lateral opening (612) and is generally circular, whereas the outer cannula (610) is elliptical. As best seen in FIG. 8, this configuration provides a two-lumen configuration with an upper cutter lumen (622) and a lower lateral lumen (624). Both the cutter lumen (622) and the lower lumen (624) are in fluid communication through one or more fluid openings (626) disposed within a portion of the cutter receiving tube (620) opposite the lateral opening (612).

[0034] The cutter receiving tube (620) is generally configured to receive a tubular cutter (630). It should be appreciated that the cutter (630) is generally configured to be movable within the cutter receiving tube (620) relative to the lateral opening (612). In some embodiments, the cutter (630) is moved proximally from the lateral opening (612) to "open" the lateral opening (612). The tissue sample is then drawn into the lateral opening (612) by vacuum supplied through the cutter lumen (622), the lateral lumen (624), or both. The cutter (630) is then advanced distally to the position shown in FIG. 8 to sever the tissue sample. The severed tissue sample can then be conveyed through the cutter (630) and into a tissue sample holder or other tissue receiving feature under vacuum supplied by the biopsy device.

[0035] The piercing tip (640) is best seen in Figures 6 and 7. As can be seen, the piercing tip (640) includes a body (642) that defines a plurality of cutting surfaces (644) at a distal end of the piercing tip (640). In this embodiment, three cutting surfaces (644) are disposed about the exterior of the body (642) to converge and thereby form a plurality of cutting edges (646). The cutting edges (646) similarly converge to form a sharp distal tip (647). Although the surface (644) is referred to herein as a "cutting surface," it should be understood that the actual cutting of tissue may be performed by other structural elements. For example, in this embodiment, the cutting edges (646) and the sharp distal tip (647) actually perform the cut. However, the cutting surface (644) merely defines the shape and / or structure of the cutting edges (646) and the sharp distal tip (647). Thus, the use of the term "cutting" in conjunction with the term "surface" herein does not necessarily imply that a physical cut of tissue is performed by such cutting surface (644).

[0036] The cutting surface (644) may be formed on the exterior of the body (642) in a variety of ways. For example, in some embodiments, the cutting surface (644) may be roughly formed by a molding technique, such as metal injection molding. The cutting surface (644) may then be further defined by cutting, grinding, polishing, or a combination thereof. In other embodiments, the cutting surface (644) may be completely formed by cutting, grinding, polishing, or a combination thereof. Still other techniques for forming the cutting surface (644) will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0037] The cut surfaces (644) in this embodiment are generally planar. In other words, each cut surface (644) lies in a single plane oriented at an angle relative to the longitudinal axis of the body (642). Although each cut surface (644) in this embodiment is shown as oriented at a particular angle relative to the longitudinal axis of the body (642), it should be understood that a variety of alternative angles may be used in other embodiments, as will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0038] The proximal end of body (642) includes an intermediate end (652) and a proximal end (654) extending proximally from intermediate end (652). Intermediate end (652) and proximal end (654) together define a generally cylindrical shape. Further, intermediate end (652) and proximal end (654) are both coaxially oriented relative to one another. However, intermediate end (652) has a larger diameter compared to the diameter of proximal end (654) such that intermediate end (652) and proximal end (654) together form a gradually decreasing cross-section, similar to the formation of a step.

[0039] Both the intermediate end (652) and the proximal end (654) are configured for reception within at least a portion of the outer cannula (610). For example, as best seen in FIG. 8, the intermediate end (652) is configured to directly abut an upper portion of the distal end of the cutter receiving tube (620) while remaining inside the outer cannula (610), while the proximal end (654) extends proximally beyond the intermediate end (652) and further into the interior of the cutter receiving tube (620). Additionally, the diameter of the proximal end (654) is generally smaller than the diameter of the cutter receiving tube (620) to provide a space between the cutter receiving tube (620) and the exterior of the proximal end (654). This space is generally configured for reception of at least a portion of the cutter (630) to facilitate severing of tissue.

[0040] In this embodiment, the body (642) of the tissue piercing tip (640) is coupled to the outer cannula (610) and the cutter receiving tube (620) by a welding process, such as laser welding. In other embodiments, the body (642) can be coupled to the outer cannula (610) and / or cutter receiving tube (620) in a variety of ways, such as by adhesive, mechanical fastening, and / or a compression fit.

[0041] As best seen in FIG. 6, the body (642) further defines a distal opening (648) disposed in a single cutting plane (644). The distal opening (648) is generally oval-shaped and communicates with a lumen (650) extending through the body (642), as described in more detail below. In this embodiment, the distal opening (648) is disposed in a cutting plane (644) oriented upward (e.g., toward the top of the page in FIG. 6). However, it should be understood that in other embodiments, the distal opening (648) can be disposed in any other cutting plane (644).

[0042] In this embodiment, the distal opening (648) is disposed entirely within the single cutting surface (644) to generally avoid interaction between the distal opening (648) and tissue while the biopsy needle (600) is piercing the tissue. In such a situation, the majority of the forces between the cutting surface (644) and the tissue are directed toward the cutting edge (646). Thus, as the tissue piercing tip (640) pierces the tissue, such tissue generally moves over the distal opening (648) rather than being caught or worn by the distal opening (648).

[0043] Although the distal opening (648) is described herein as being located entirely on a single cutting surface (644), it should be understood that in other embodiments, the distal opening (648) may be located across multiple cutting surfaces (644). For example, in some embodiments, the distal opening may be located adjacent to the distal tip (647) and thus may intersect all three cutting surfaces (644). In such embodiments, the combination of the distal tip (647) and cutting surfaces (644) may resemble a hypodermic needle.

[0044] As described in more detail below, the distal opening (648) is generally configured to transmit a marker from within the body (642). As such, it should be understood that the size or diameter of the distal opening (648) generally corresponds to the size or diameter of a marker, such as the markers (100, 300) described above. Similarly, since the distal opening (648) in this example is disposed entirely on a single cutting surface (644), it should be understood that the one or more cutting surfaces (644) can also be sized in proportion to the size or diameter of the marker. The distal opening (648) is large enough to accommodate the marker, while generally being small enough to prevent tissue ingress. As described in more detail below, this sizing allows the distal opening (648) to engage and self-seal with adjacent tissue when the distal opening (648) is not being used for marker delivery.

[0045] As best seen in FIGS. 7 and 8 , the body (642) defines a lumen (650) extending from a distal opening (648) to a proximal opening (651). The cross-sectional diameter or size of the lumen (650) generally corresponds to the diameter of the distal opening (648). Similar to the distal opening (648) described above, the lumen (650) is generally sized to transmit the marker through the body (642) from the proximal opening (651) to the distal opening (648). While the cross-sectional diameter or size of the lumen (650) in this example is shown as being generally consistent along the length of the body (642), it should be understood that in some embodiments, the cross-sectional diameter or size of the lumen (650) may vary along the length of the body (642). For example, in some embodiments, the cross-sectional diameter or size of lumen (650) may taper inwardly as lumen (650) extends distally from proximal opening (651). In such embodiments, lumen (650) may thus function as a funnel to move the marker to a desired location. Of course, other sizes and / or shapes of lumen (650) may become apparent to one of ordinary skill in the art in view of the teachings herein.

[0046] As best seen in FIG. 7, the lumen (650) is oriented at a slight angle relative to the longitudinal axis of the body (642). In particular, the lumen (650) is angled such that the lumen (650) extends upward as the lumen (650) extends distally. In this embodiment, this angle exists to account for the difference in orientation between the distal opening (648) and the proximal opening (651). By way of example only, the particular angle of the lumen (650) in this embodiment is approximately 5°. However, it should be understood that in other embodiments, the angle of the lumen (650) may range between 2 and 10°. In still other embodiments, a variety of other angles may be used depending on the particular size, shape, and configuration of the tissue piercing tip (340).

[0047] A proximal opening (651) is defined by the proximal end (654) of the body (642). As best seen in FIG. 8, the proximal opening (651) connects the lumen (650) to the interior of the needle (600). As will be explained in more detail below, this configuration allows a marker to be delivered through the cutter (630) and into the lumen (650). It should therefore be understood that the proximal opening (651) is generally disposed to align with the cutter (630). Additionally, the proximal opening (651) defines a diameter or size that corresponds to the diameter or size of a marker such that the proximal opening (651) is generally configured to receive the marker.

[0048] B. Exemplary Marker Delivery Device with End Deployment 9-11 illustrate an exemplary marker delivery device (700) that can be used with the needle (600) described above. As best seen in FIG. 9, the marker delivery device (700) includes an elongated outer cannula (712) having a marker outlet (714). The outer cannula (712) is generally sized to slidably fit within the cutter (630) of the needle (600). Similarly, the length of the cannula (712) is generally sized to match the length of the needle (600). It should be understood that in some embodiments, the particular length of the cannula (712) may be greater than the length of the needle (600). For example, in some embodiments, the needle (600) and / or cutter (630) may be sized to fit within the cutter (630) of the needle (600). 3 The proximal end of the cannula (712) can be coupled to a tissue sample holder or other tissue collection device. In such an embodiment, the length of the cannula (712) can be adjusted to fit the length of the needle (600) / cutter (600). 3 0) and various tissue collection devices.

[0049] A grip (716) can be provided at a proximal end of the cannula (712). A push rod (718) can be provided, the push rod (718) extending coaxially within the cannula (712) such that the push rod (718) is configured to translate within the cannula (712) to displace one or more markers through the marker outlet (714). The push rod (718) generally has sufficient compressive stiffness to push the markers out of the internal lumen (715) of the cannula (712) through the marker outlet (714), but is relatively flexible in bending. A plunger (720) is coupled at the proximal end of the push rod (718) for urging the push rod (718) distally within the cannula (712) to deploy the markers from within the cannula (712).

[0050] FIG. 10 shows a detailed view of the distal end (722) of the cannula (712). As can be seen, the marker outlet (714) is centrally located at the distal end (722). It should be understood that the marker outlet (714) is therefore generally coaxially located with the internal lumen (715) of the cannula (712). As a result, the marker delivery device (700) of this example is an "end-deploying" marker delivery device rather than a "side-deploying" marker delivery device. As will be explained in more detail below, this configuration generally allows the marker delivery device (700) to be used with a needle (600) to deploy a marker from a distal opening (648) at the distal tip (647) rather than a lateral opening (612).

[0051] Distal end 722 is generally rounded relative to the outer diameter of cannula 712. As such, it should be understood that distal end 722 generally tapers or is rounded inwardly toward marker outlet 714. As will be appreciated, this configuration generally avoids snagging of distal end 722 at various internal locations of needle 600. Although distal end 722 is shown as rounded, it should be appreciated that a variety of other alternative shapes may be used, such as frusto-conical, tapered, and / or other.

[0052] As best seen in FIG. 11 , end portion (722) is shown as a separate component inserted into cannula (712). In particular, end portion (722) includes a distal tip (724) and an inactive portion (726). The distal tip (724) defines a rounded portion of end portion (722) that is external to cannula (712). An insert portion (726) extends proximally from the distal tip (724) and is disposed within cannula (712). The insert portion (726) defines a tapered diameter that is distally slightly oversized relative to the inner diameter of inner lumen (715). As the insert portion (726) extends proximally away from the distal tip (724), the diameter of the insert portion (726) gradually decreases until it is approximately equal to the inner diameter of inner lumen (715). This configuration generally provides a press-fit configuration between distal end 722 and cannula 712. Additionally, this configuration provides a gradual transition between cannula 712 and distal end 722 to prevent the marker from getting caught during the transition. While a press-fit or mechanical fit is used in this embodiment, it should be understood that in other embodiments, distal end 722 can be secured to cannula 712 using other fastening methods, such as a snap fit, adhesive, welding, and / or the like. In yet other embodiments, distal end 722 can be integral with cannula 712.

[0053] The marker delivery device (700) of this example is shown with a marker (300). However, it should be understood that in other examples, any suitable alternative marker can be used with the marker delivery device (700). The marker (300) is initially positioned within the cannula (712) distal to the end of the push rod (718). It should be understood that the push rod (718) can then be advanced within the cannula (712) to push the marker (300) out of the marker outlet (714). Although not shown, it should be understood that in some examples, the internal lumen (715) can include a detent, internal ridge, rubber gasket, or other similar feature to retain the marker (300) within the cannula (712) until the marker (300) is actuated by the push rod (718) out of the marker outlet (714).

[0054] C. Exemplary Method for End Development of Biopsy Site Markers 12A-12C illustrate an exemplary use of the marker delivery device (700) with a needle (600). As seen in FIG. 12A, the cannula (712) of the marker delivery device (700) is first inserted into the needle (600) through the cutter (630). In particular, the cannula (712) is inserted into the needle (600) through the cutter (630) until the distal end (722) contacts the proximal end (754) of the tissue piercing tip (640). In this position, the cannula (712) is coaxial with the cutter (630). This aligns the marker outlet (714) with the proximal opening (651) of the tissue piercing tip (640).

[0055] Once the cannula (712) is positioned within the needle (600) as shown in Figure 12A, the marker delivery device (700) is positioned for deployment of the marker (300). It should therefore be understood that at this stage, the marker (300) is positioned within the cannula (712). Similarly, the push rod (718) is in a pre-actuated state corresponding to a proximal position within the cannula (712).

[0056] Insertion of the marker delivery device (700) into the needle (600) for deployment of the marker can occur at various stages during a biopsy procedure. For example, in some embodiments, the marker delivery device (700) can be inserted into the needle (600) after the biopsy procedure is completed, while the needle (600) is still in place within the patient even though all desired tissue samples have been collected from a given biopsy site. Alternatively, the marker delivery device (700) can be inserted into the needle (600) at one or more intermediate stages during the biopsy procedure. In still other embodiments, the marker delivery device (700) can be used at other stages where marking of a site of interest is desired. Additionally, although not shown, it should be understood that insertion of the marker delivery device (700) may involve other procedure steps, such as adjustment of the tissue sample holder, removal of the tissue sample holder, or removal of parts of the tissue sample holder, or removal of other portions of the biopsy device.

[0057] Regardless of the particular step at which marking is performed, it should be understood that in some embodiments, the needle (600) may require at least some repositioning relative to the biopsy site prior to marking. For example, in this embodiment, the tissue sample is collected through the lateral opening (612) of the needle (600), while the marking is performed through a distal opening (648) that is positioned away from the lateral opening (612). Thus, in some embodiments, it may be desirable to reposition the needle (600) to align the distal opening (648) with the biopsy site that was originally positioned adjacent the lateral opening (612).

[0058] Once the cannula (712) has been inserted into the needle (600), the operator may desire to deploy the marker (300) from the marker delivery device (700). Deployment of the marker (300) is illustrated in Figures 12B and 12C. As can be seen, deployment is initiated by distally advancing the push rod (718) using the plunger (720) or a combination of the plunger (720) and grip (716). As the push rod (718) is advanced, as shown in Figure 12B, the distal end of the push rod (718) engages the marker (300) and moves the marker distally with the push rod (718).

[0059] As marker (300) is moved distally via push rod (718), marker (300) is pushed through inner lumen (715) of cannula (712), through distal end (722), and out marker outlet (714). As marker (300) is pushed out of marker outlet (714), it enters lumen (650) of tissue piercing tip (640) through proximal opening (651). It should be appreciated that because lumen (650) is oriented at an angle as described above, lumen (650) may provide some alignment of marker (300) along the axis of lumen (650).

[0060] As best seen in FIG. 12C, further advancement of the push rod (718) advances the marker (300) further through the lumen (650) until the marker (300) fully exits the needle (600) through the distal opening (648) of the tissue-piercing tip (640). Although not shown, it should be understood that in some applications, a distal portion of the push rod (718) may also exit the needle (600) through the distal opening (648) to provide further piercing of the marker (300) into the tissue. However, in other applications, the push rod (718) may instead remain within the lumen (650), as shown in FIG. 12C.

[0061] Once the markers (300) have been deployed as shown in Figures 12A-12C, the marker delivery device (700) can be removed from the needle (600). If additional marking is desired, the marker delivery device (700) can be reloaded with additional markers (300). Alternatively, another identical or substantially identical marker delivery device (700) can be used for deployment of additional markers (300). If additional marking is not desired after deployment of the markers (300), the needle (600) can be removed from the patient, either in conjunction with or separately from the removal of the marker delivery device (700).

[0062] IV. Exemplary Combinations The following examples relate to various non-exhaustive methods 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 of this application. No disclaimer is intended. The following examples are presented 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 components referred to in the following examples. Thus, unless specifically and explicitly indicated by the inventor later or by the intended successor of the inventor, none of the aspects or features referred to below should be considered critical. If any claim is presented in this application or any subsequent application related to this application that includes 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.

[0063] Example 1 1. A needle for use with a biopsy device, comprising: an outer cannula defining a cutter lumen for receiving a cutter therein and a lateral lumen adjacent the cutter lumen; a body defining a plurality of cutting surfaces, a marker opening disposed in at least one cutting surface of the plurality of cutting surfaces, and a tissue piercing tip having a marker lumen extending distally through the body from the marker opening to a proximal opening, the proximal opening in communication with the cutter lumen.

[0064] Example 2 The needle of example 1, wherein the marker opening is located on a single cutting surface of the multiple cutting surfaces.

[0065] Example 3 The needle of example 1, wherein the marker opening is disposed on two or more cutting surfaces of the plurality of cutting surfaces.

[0066] Example 4 The needle of any one or more of Examples 1-3, wherein the proximal opening is coaxial with an axis defined by the cutter lumen.

[0067] Example 5 The needle of any one or more of Examples 1-4, wherein the marker lumen is disposed at an oblique angle relative to a central axis of the outer cannula.

[0068] Example 6 The needle of any one or more of Examples 1-5, wherein the marker lumen is sized to receive a marker therein.

[0069] Example 7 The needle of any one or more of Examples 1-6, wherein the marker lumen is sized to prevent prolapse of tissue within the marker lumen.

[0070] Example 8 The needle of any one or more of Examples 1-7, wherein the cutting surfaces of the plurality of cutting surfaces converge to form one or more cutting edges.

[0071] Example 9 A needle as described in any one or more of Examples 1-8, wherein the cutter defines a lumen configured to receive a cannula of a marker delivery device such that the marker delivery device can be received within the cutter to deploy a marker through the marker lumen.

[0072] Example 10 11. A biopsy system comprising: a biopsy device including a body, a needle extending distally from the body, and a cutter movable relative to the needle, the needle including an outer cannula, a tissue piercing tip fixed to a distal end of the outer cannula, and a cutter lumen configured to receive the cutter, the tissue piercing tip defining a marker lumen communicating with an exterior of the cutter and with the cutter lumen; a marker delivery device including an elongated cannula having a distal end with a marker outlet disposed at the distal end; and a biopsy site marker, the marker delivery device configured to expel the biopsy site marker through the marker outlet and out of the needle through the marker lumen defined by the tissue piercing tip.

[0073] Example 11 The biopsy system of example embodiment 10, wherein the elongated cannula of the marker delivery device is configured for insertion into the cutter of the biopsy device.

[0074] Example 12 The biopsy system of any one or more of Examples 10 and 11, wherein the end of the marker delivery device defines a rounded distal tip.

[0075] Example 13 13. The biopsy system of example 12, wherein the marker outlet is centered on the rounded distal tip.

[0076] Example 14 The biopsy system of any one or more of Examples 10-13, wherein the tissue-piercing tip further defines a plurality of cutting surfaces, and the marker lumen extends through a single cutting surface of the plurality of cutting surfaces.

[0077] Example 15 The biopsy system of any one or more of Examples 10-13, wherein the tissue-piercing tip further defines a plurality of cutting surfaces, and the marker lumen extends through two or more of the plurality of cutting surfaces.

[0078] Example 16 A biopsy system described in any one or more of Examples 10 to 15, wherein the cutter is configured to align the marker outlet of the marker delivery device with the marker lumen of the tissue-piercing tip.

[0079] Example 17 A biopsy system described in any one or more of Examples 10 to 16, wherein the needle further includes a cutter receiving tube configured to receive the cutter, and the cutter receiving tube and the outer cannula together define a lateral lumen disposed below the cutter.

[0080] Example 18 The biopsy system of any one or more of Examples 10 to 17, further comprising a tissue sample holder in communication with the cutter and configured to receive one or more tissue samples cut by the cutter, the tissue sample holder configured to receive the elongated cannula of the marker delivery device for marking through the cutter.

[0081] Example 19 19. The biopsy system of any one or more of Examples 10-18, wherein the marker lumen extends through the tissue-piercing tip at an angle relative to a central longitudinal axis of the needle.

[0082] Example 20 19. The biopsy system of any one or more of Examples 10-18, wherein the marker lumen extends through the tissue-piercing tip at an angle relative to a central longitudinal axis of the needle such that the marker lumen protrudes upward as it extends distally through the tissue-piercing tip.

[0083] Example 21 1. A method for marking a biopsy site, comprising: positioning a biopsy needle adjacent to a biopsy site; collecting one or more tissue samples from the biopsy site by moving a cutter relative to the needle; inserting a marker delivery device into the needle, through the cutter; and expelling a marker from the marker delivery device toward the biopsy site through a marker lumen in the tissue-piercing tip of the needle.

[0084] Example 22 22. The method of example 21, further comprising repositioning the biopsy needle to align the marker lumen with the biopsy site.

[0085] Example 23 23. The method of example embodiment 22, wherein the step of expelling the marker is performed by advancing a push rod through a cannula of the marker delivery device.

[0086] Example 24 The method of any one or more of Examples 21-23, wherein the step of collecting one or more tissue samples comprises prolapse of tissue through a lateral opening in the biopsy needle.

[0087] Example 25 The method of any one or more of Examples 21-24, wherein the step of inserting the marker delivery device into the needle includes inserting the marker delivery device into a tissue sample holder to access the cutter.

[0088] V. Conclusion Any patent, publication, or other disclosure material that is said to be incorporated herein by reference, in whole or in part, is 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. Thus, and to the extent necessary, the disclosure expressly set forth herein takes precedence over 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 content set forth herein, is incorporated only to the extent that no contradiction occurs between the incorporated material and the existing disclosure material.

[0089] Although 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. Some of such possible modifications have been mentioned, but others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Thus, 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 construction and operation shown and described in the specification and drawings.

[0090] [Embodiment] (1) A needle for use with a biopsy device, comprising: (a) an outer cannula defining a cutter lumen for receiving a cutter therein and a lateral lumen adjacent the cutter lumen; (b) a tissue piercing tip having a body defining a plurality of cutting surfaces, a marker opening disposed in at least one of the plurality of cutting surfaces, and a marker lumen extending distally through the body from the marker opening to a proximal opening, the proximal opening in communication with the cutter lumen; The needle. (2) The needle of embodiment 1, wherein the marker opening is located on a single cutting surface of the multiple cutting surfaces. (3) The needle of embodiment 1, wherein the marker opening is located on two or more cutting surfaces of the plurality of cutting surfaces. (4) The needle of any one or more of embodiments 1-3, wherein the proximal opening is coaxial with an axis defined by the cutter lumen. (5) The needle of any one or more of embodiments 1-4, wherein the marker lumen is disposed at an oblique angle relative to a central axis of the outer cannula.

[0091] (6) The needle of any one or more of embodiments 1-5, wherein the marker lumen is sized to receive a marker therein. (7) The needle of any one or more of embodiments 1-6, wherein the marker lumen is sized to prevent prolapse of tissue within the marker lumen. (8) The needle according to any one or more of the preceding claims, wherein each of the plurality of cutting surfaces converge to form one or more cutting edges. (9) The needle of any one or more of embodiments 1 to 8, wherein the cutter defines a lumen configured to receive a cannula of a marker delivery device such that the marker delivery device can be received within the cutter for deployment of a marker through the marker lumen. (10) A biopsy system comprising: (a) a biopsy device including a body, a needle extending distally from the body, and a cutter movable relative to the needle, the needle including an outer cannula, a tissue piercing tip secured to a distal end of the outer cannula, and a cutter lumen configured to receive the cutter, the tissue piercing tip defining a marker lumen in communication with an exterior of the cutter and with the cutter lumen; (b) a marker delivery device comprising an elongated cannula having a distal end with a marker outlet disposed at the distal end; (c) a biopsy site marker, wherein the marker delivery device is configured to expel the biopsy site marker through the marker outlet and out of the needle through the marker lumen defined by the tissue-piercing tip; and A biopsy system comprising:

[0092] (11) The biopsy system of embodiment 10, wherein the elongated cannula of the marker delivery device is configured for insertion into the cutter of the biopsy device. (12) A biopsy system described in any one or more of embodiments 10 and 11, wherein the end portion of the marker delivery device defines a rounded distal tip. (13) The biopsy system of embodiment 12, wherein the marker outlet is located at the center of the rounded distal tip. (14) A biopsy system according to any one or more of embodiments 10 to 13, wherein the tissue-piercing tip further defines a plurality of cutting surfaces, and the marker lumen extends through a single cutting surface of the plurality of cutting surfaces. (15) A biopsy system according to any one or more of embodiments 10 to 13, wherein the tissue-piercing tip further defines a plurality of cutting surfaces, and the marker lumen extends through two or more of the plurality of cutting surfaces.

[0093] (16) A biopsy system described in any one or more of embodiments 10 to 15, wherein the cutter is configured to align the marker outlet of the marker delivery device with the marker lumen of the tissue-piercing tip. (17) The biopsy system of any one or more of embodiments 10 to 16, wherein the needle further includes a cutter receiving tube configured to receive the cutter, and the cutter receiving tube and the outer cannula together define a lateral lumen disposed below the cutter. (18) The biopsy system of any one or more of embodiments 10 to 17, further comprising a tissue sample holder in communication with the cutter and configured to receive one or more tissue samples cut by the cutter, the tissue sample holder configured to receive the elongated cannula of the marker delivery device for marking through the cutter. (19) A biopsy system according to any one or more of embodiments 10 to 18, wherein the marker lumen extends through the tissue-piercing tip at an angle relative to the central longitudinal axis of the needle. (20) A method for marking a biopsy site, comprising: (a) positioning a biopsy needle adjacent to a biopsy site; (b) collecting one or more tissue samples from the biopsy site by moving a cutter relative to the needle; (c) inserting a marker delivery device through the cutter and into the needle; (d) expelling a marker from the marker delivery device toward the biopsy site through a marker lumen in the tissue-piercing tip of the needle; The method comprising:

Claims

1. 1. A needle for use with a biopsy device, comprising: (a) an outer cannula defining a cutter lumen for receiving a cutter therein and a lateral lumen adjacent the cutter lumen; (b) a tissue-piercing tip having a body defining three or more cutting edges, two adjacent cutting edges of the three or more cutting edges together defining a cutting surface for a total number of cutting surfaces equal to the three or more cutting edges, a marker opening disposed in a single cutting surface of the same number of cutting surfaces, and a marker lumen extending distally through the body from a proximal opening to the marker opening, the proximal opening being in communication with the cutter lumen; Equipped with The needle is positioned at an oblique angle of 2 to 10 degrees relative to a central axis of the outer cannula such that the marker lumen extends outwardly of the outer cannula toward the single cutting surface.

2. The needle of claim 1 , wherein the proximal opening is coaxial with an axis defined by the cutter lumen.

3. The needle of claim 1 or 2, wherein the marker lumen is sized to receive a marker therein.

4. The needle of any one of claims 1 to 3, wherein the marker lumen is sized to prevent prolapse of tissue within the marker lumen.

5. The needle of any one of claims 1 to 4, wherein two adjacent cutting surfaces of said equal number of cutting surfaces converge to form each cutting edge of said three or more cutting edges.

6. 6. The needle of claim 1, wherein the cutter defines a lumen configured to receive a cannula of a marker delivery device such that the marker delivery device can be received within the cutter for deployment of a marker through the marker lumen.

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