Biopsy site marker with enhanced visualization and non-mobile characteristics

Abstract

The biopsy site marker includes a carrier and a marker element. The marker element includes a base portion, a first anchor, and a second anchor. The base portion is at least partially disposed within the carrier. At least a portion of the first anchor and the second anchor extend laterally and outwardly away from the base portion. The first anchor and the second anchor are configured to move relative to the base portion to engage tissue at the biopsy site. The base portion defines a plurality of curved portions disposed between the first anchor, the second anchor, and a curved proximal end. The plurality of curved portions are configured to define a distinctive appearance under x-ray visualization.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 337,768, entitled “Biosy Site Marker with Increased Visualization and Non-Migration Features,” filed May 3, 2022, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Many patients undergo breast biopsies because of irregular mammograms and tactile abnormalities. Biopsies can include surgical excision biopsies, as well as stereotactic and ultrasound-guided needle breast biopsies. With image-guided biopsies, a radiologist or other physician can take a small sample of the irregular tissue for laboratory analysis. If the biopsy indicates malignancy, additional surgery (e.g., lumpectomy or mastectomy) may be required. With needle biopsies, the patient may return before 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 can be used to locate the biopsy site. A marker may be placed at the time of the biopsy to aid in repositioning the biopsy site.

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

[0004] Once a marker is placed at a biopsy site, the marker may be later repositioned to identify the biopsy site at a subsequent follow-up procedure. In some circumstances, the placed marker may not perfectly correspond to the biopsy site when the marker is repositioned. For example, the marker may move to another nearby location during the intervening time between the biopsy procedure and the subsequent follow-up procedure. Movement of the biopsy site marker may cause difficulties in identifying the biopsy site during the subsequent follow-up procedure. Therefore, it may be desirable to incorporate features into the marker that maintain the marker in a fixed location over time.

[0005] Examples of markers having features configured to reduce migration are disclosed in U.S. Pat. No. 10,842,591, entitled "Biopsy Marker with Anchoring Capabilities," issued on November 24, 2020, International Publication No. WO 2021 / 188481, entitled "Biopsy Site Markers with Non-Migration Features," issued on September 23, 2021, and International Publication No. WO 2021 / 188479, entitled "Non-Migrating Biopsy Site Identifiers," issued on September 23, 2021, the disclosures of which are incorporated by reference in their entireties into this specification.

[0006] Although several systems and methods have been made and used for marking biopsy sites, it is believed that no one prior to the present inventors made or used the invention as recited in the accompanying claims.

[0007] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference characters identify the same elements and in which some components or portions of components are shown in phantom, as depicted by dashed lines. [Brief description of the drawings]

[0008] [Figure 1] 1 shows a perspective view of an example biopsy site marker. [Diagram 2] FIG. 2 shows a perspective view of a marker element of the marker of FIG. 1. [Diagram 3] 3 shows a front view of the marker element of FIG. 2. [Figure 4] 3 shows a side view of the marker element of FIG. 2. [Diagram 5] 3 shows an exploded perspective view of the marker element of FIG. 2. [Figure 6] FIG. 2 shows a perspective view of an alternative marker element that can be readily incorporated into the marker of FIG. 1. [Figure 7] 7 shows a front view of the marker element of FIG. 6. [Figure 8] 7 shows a side view of the marker element of FIG. 6. [Figure 9] FIG. 2 shows a perspective view of another alternative marker element that can be readily incorporated into the marker of FIG. 1. [Figure 10] 10 shows a front view of the marker element of FIG. 9. [Figure 11] 2 shows a perspective view of yet another alternative marker element that can be readily incorporated into the marker of FIG. 1. [Figure 12] 12 shows a front view of the marker element of FIG. 11. [Figure 13] 12 shows a side view of the marker element of FIG. 11. [Figure 14] 2 shows a perspective view of yet another alternative marker element that can be readily incorporated into the marker of FIG. 1. [Figure 15] 15 shows a front view of the marker element of FIG. 14. [Figure 16] 15 shows a side view of the marker element of FIG. 14. [Figure 17] 1A shows an exemplary embodiment of a biopsy site marker placement according to an embodiment of the present disclosure; 1B shows an exemplary embodiment of a biopsy site marker placement according to an embodiment of the present disclosure; and 1C shows an exemplary embodiment of a biopsy site marker placement according to an embodiment of the present disclosure. [Figure 18]1 shows a perspective view of an exemplary marker delivery device. [Figure 19] 19 shows a side cross-sectional view of the marker delivery device of FIG. 18. [Figure 20] 19 shows a cross-sectional view of a marker deployed from the distal portion of the marker delivery device of FIG. 18 through a side aperture of a biopsy needle to mark a biopsy site. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The drawings are not intended to be limiting in any way, and it is envisioned that various embodiments of the invention may be practiced in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise configurations shown.

[0010] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention is capable of other different 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.

[0011] It may be beneficial to be able to mark the location or margins of a lesion, either temporarily or permanently, before or immediately after removing or sampling it. Marking before removal may help ensure excision of the entire lesion, if desired. Alternatively, in the event that the lesion is unintentionally removed in its entirety, marking the biopsy site immediately after the procedure allows for its location to be reconstructed for future identification.

[0012] It may be desirable for the marker to remain visible under ultrasound once it is placed at the biopsy site. 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. Microcalcifications are commonly used in the art to identify suspicious lesions or masses. Thus, it is generally desirable for the ultrasound appearance to be distinguishable as a marker and not erroneously identified as a new mass.

[0013] I. Examples of markers to limit movement and improve visualization As mentioned above, markers may be used in several contexts to identify the location of a biopsy site after a biopsy procedure has been performed. Identification of the marker may be performed under various imaging modalities, such as ultrasound visualization, x-ray visualization, and / or others. However, in the intervening time between the biopsy procedure and follow-up identification, some marker configurations may be susceptible to movement, which may lead to inaccuracies in the subsequent identification of the biopsy site. Thus, in some situations, it may be desirable for the marker to include features configured to maintain the location of the marker within the tissue.

[0014] When locating a marker, it may be desirable for the marker to have a distinctive characteristic under the imaging modality being used. Such distinctive characteristics may make the marker more easily identifiable under the particular imaging modality being used by providing contrast between the natural tissue structure and the marker itself. Furthermore, such distinctive characteristics may be beneficial in situations where multiple markers are used to mark different biopsy sites. When using multiple markers, it may be desirable to have one marker that has a distinctive visual profile relative to the other markers to aid in distinguishing the biopsy sites.

[0015] A. Example of a marker with a spiral visualization feature. 1-4 show examples of markers (100) generally configured to be secured to tissue using anchors aligned along multiple planes to limit movement of the marker (100) relative to initial placement in tissue. The marker (100) is further generally configured with specific visualization features to provide a distinctive appearance under various imaging modalities, such as X-ray imaging, as described in more detail below. In this variation, the marker (100) includes a carrier (110) and a marker element (120). The carrier (110) generally includes a bioabsorbable marker material (112). Thus, the carrier (120) is generally configured to be absorbed into the patient's body after placement of the marker (100) in the biopsy cavity, as described in more detail below. In some variations, the carrier (110) may include a plurality of microbubbles to enhance visualization of the carrier (110) under ultrasound. As described in more detail below, the marker material (112) is generally bioabsorbable, such that the marker material (112) may be absorbed into the patient's tissue generally over time. In this variation, the marker material (112) comprises a hydrogel. Such a hydrogel may be initially in a dehydrated state and absorb fluid to expand to a hydrated state before being absorbed into the tissue. Although this variation uses a hydrogel, it should be understood that in other variations, the marker material (112) may comprise other suitable bioabsorbable materials.

[0016] Hydration of the marker material (112) of the carrier (110) by the natural moisture of the surrounding tissue may cause the polymers defining the hydrogel to expand. This expansion may reduce the tendency of the marker (100) to migrate within the patient's body. Such expansion may also serve to center the marker (100) within the biopsy site as the expansion progresses. As the hydrogel expands, the naturally occurring moisture present from the surrounding tissue may allow for increased sound transmission due to hydration, resulting in a more hypoechoic appearance, making it easier to visualize on follow-up ultrasound examinations.

[0017] The carrier (110) in this example defines a generally cylindrical shape, although various other shapes may be used. The particular shape of the carrier (110) may be used in some variations to facilitate use with a device for deployment at a biopsy site. For example, as described in more detail below, in some variations, the marker (100) may be placed at a biopsy site using a cylindrical tube or cannula. Thus, in such variations, it may be desirable for the carrier (110) to be cylindrical in shape to facilitate ease of use with such a cylindrical tube or cannula. In other variations, the carrier (110) may have one or more depressions, bulges, or irregular shapes to facilitate visualization of the carrier (110) using an imaging modality such as ultrasound after deployment of the marker (100) at a biopsy site. Of course, other configurations of the carrier (110) may be used in other variations, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0018] The marker element (120) is generally configured as a permanent structure that allows for identification of the biopsy site after the carrier (110) is absorbed into tissue. Thus, the marker element (120) is generally non-bioabsorbable. The marker element (120) may include a radiopaque or echogenic marker, with at least a portion of the marker element (120) being embedded with the marker material (112) of the carrier (110). For example, the marker element (120) may include a metal, a hard plastic, or other radiopaque or hyperechoic material. While the marker element (120) in this variation is used with the carrier (110), it should be understood that in some variations, the carrier (110) may be omitted and the marker (100) may include only the marker element (120). In such variations, the marker (100) may be referred to as a "bare" or "clip" style marker (100).

[0019] The marker element (120) includes a base portion (130) and a number of anchors (142, 152) (alternatively referred to as "outriggers") extending outwardly from the base portion (130). In this variation, the base portion (130) is generally disposed entirely within the carrier (110). The base portion (130) is defined by one or more wires bent into a predetermined shape. Generally, the combination of the one or more wires forming the base portion (130) is configured to provide a unique pattern for enhanced visualization under x-ray and / or ultrasound visualization. Although the base portion (130) is shown in this variation as having a particular orientation (e.g., axially aligned) within the carrier (110), it should be understood that the base portion (130) may have a variety of alternative orientations in other variations.

[0020] The base portion (130) of this variation includes a first wire (132) and a second wire (134). The wires (132, 134) are twisted together to form a helical or spiral shaped pattern. Because there are two wires (132, 134) in this variation, the formation of the wires (132, 134) may be characterized as a double helix or double spiral pattern. Although this variation uses two wires (132, 134), it should be understood that in some variations, any other suitable number of wires (132, 134) may be used, such as a single wire, three wires, four wires, or any other suitable number.

[0021] As best seen in FIG. 5, each wire (132, 134) has a substantially similar shape. Moreover, each wire (132, 134) is configured to mate with the other wire (134, 132) to form a double helix in which the wires (132, 134) together define a generally cylindrical profile. The particular shape of each wire (132, 134) may be desirable in some variations to provide a unique visual profile under x-ray visualization. The particular shape of each wire (132, 134) may also be desirable to provide multiple reflective surfaces oriented at different angles to reflect ultrasonic energy and thereby provide enhanced ultrasonic visualization, particularly after absorption by the carrier (110).

[0022] One end of each wire (132, 134) may be bent to provide an end (136). In this variation, end (136) is formed by bending each wire (132, 134) away from one another to provide a generally rounded profile for end (136). The circular profile shown in this variation may be desirable in some circumstances to provide atraumatic performance for marker (100) with respect to tissue adjacent thereto.

[0023] Each wire (132, 134) terminates at an end (136) separately from the other wires (134, 132). It should therefore be understood that each wire (132, 134) is generally separate and discrete from the other wires (132, 134), and the wires (132, 134) are connected only by the helical pattern formed on each wire (132, 134). In other words, each wire (132, 134) in this variation is a separate component. However, in other variations, the wires (132, 134) may be connected into a single wire with two portions corresponding to the first wire (132) and the second wire (134). In other words, the wires (132, 134) may be formed from a single continuous body of material. In such a variation, the first wire (132) may be folded back on itself and curved to form the second wire (134) at the end (136).

[0024] Each anchor (142, 152) extends distally away from the base portion (130) and protrudes from a portion of the carrier (110). The particular extension of each anchor (142, 152) includes a distal extension component and a lateral extension component. Thus, each anchor (142, 152) extends both distally and outwardly relative to the base portion (130) and the carrier (110). This combination of extension components is generally configured to facilitate engagement with tissue using each anchor (142, 152) even in the presence of the carrier (110) prior to resorption of the carrier (110).

[0025] Each anchor (142, 152) extends at an angle relative to the longitudinal axis defined by the base portion (130). In this variation, the particular angle relative to the longitudinal axis may be about 55°. In other variations, the angle may be between about 50° and 60°. In yet other variations, the angle may be between about 45° and about 65°. Of course, in still other variations, a variety of suitable angles may be used, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0026] Although each anchor (142, 152) is described herein as extending outwardly or laterally relative to a longitudinal axis defined by the base portion (130), it should be understood that in some variations, each anchor (142, 152) may be configured to move relative to the extensions described herein. For example, as described in more detail below, the marker (100) may be used in conjunction with a marker delivery device or other deployment apparatus having a cannula. In such use, each anchor (142, 152) may be moved to a compressed configuration in which each anchor (142, 152) is disposed within a circular footprint defined by the carrier (110). In other words, each anchor (142, 152) may be compressed such that the marker (100) may fit within a cannula having a diameter that corresponds approximately to the diameter of the carrier (110). Upon deployment from the cannula, each anchor (142, 152) may be released and moved to an extended position described herein. Thus, the outward extension of each anchor (142, 152) described above may correspond to a natural or relaxed configuration of each anchor (142, 152) when used to engage tissue. Alternatively, in some variations, a particular extension of each anchor (142, 152) may be responsive to hydration of the carrier (110) such that it cannot reach its natural, relaxed, or fully extended configuration until the carrier (110) is hydrated.

[0027] Each anchor (142, 152) includes a respective anchor coil (146, 156) disposed at a distal end of each anchor (142, 152). Each anchor coil (146, 156) is generally configured to engage tissue to maintain the marker (100) in place at the biopsy site and to provide a unique pattern that enhances visualization under x-ray and / or ultrasound visualization. The particular shape of each anchor coil (146, 156) includes one or more wire loops. In other words, each anchor coil (146, 156) is formed by a wire looped on itself to provide an eyelet-shaped configuration. In this configuration, the one or more wire loops formed by each anchor coil (146, 156) can promote tissue ingrowth to enhance anchoring of the marker (100). It should be understood that while in this variation, one or more circular loops are used in each anchor coil (146, 156), in other variations, different shapes may be used. Examples of suitable alternative shapes may include teardrop shapes, square or rectangular shapes, triangular shapes, helical shapes, corkscrew shapes, and / or others. Alternatively, as described in more detail below, in some variations, one or more of the anchor coils (146, 156) may be omitted and replaced with an end configuration having a non-coil shape. For example, in some variations, one or more of the anchor coils (146, 156) may be replaced with a bent wire section that is ridged, zigzag, or M-shaped.

[0028] Each of the anchors (142, 152) in this variation is integral with the corresponding first wire (132) and second wire (134), respectively. In other words, each of the anchors (142, 152) may be formed by a single wire that may also form part of the base portion (130). In other variations, one or more of the anchors (142, 152) may be separately attached to the base portion (130) by various coupling configurations. As described above with respect to the base portion (130), the first wire (132) and the second wire (134) may be a single wire in some variations that is bent to form both the first wire (132) and the second wire (134). Thus, in such variations, each of the anchors (142, 152) may be formed by a single continuous wire that is bent to form the first wire (132), the second wire (134), and each of the anchors (142, 152) in the same manner.

[0029] Although not shown, it should be understood that each anchor (142, 152) may include one or more additional spring features or coils similar to anchor coil (146, 156) but oriented proximally of each anchor coil (146, 156). Such additional coils may be desirable to add spring-based functionality to each anchor (142, 152) to allow each anchor (142, 152) to compress for use with a marker deployer and then expand upon deployment. Such additional coils may also be desirable to provide additional geometric features to promote tissue ingrowth and / or other forms of tissue engagement.

[0030] Additionally or alternatively, in some variations, such spring-based functionality may be facilitated by the materials used for each anchor (142, 152). For example, in some variations, each anchor (142, 152) may include a shape memory alloy that is engineered to have a pre-deployed shape and a post-deployed shape. Each anchor (142, 152) may then be configured to transition from the pre-deployed shape to the post-deployed shape based on tissue temperature and / or other relevant temperatures.

[0031] Each anchor (142, 152) in this variation is shown as being substantially similar in size, shape, and configuration. However, even in this variation, one anchor (152) may be offset distally from another anchor (142). In other words, the anchor (152) may include a distal protrusion before extending distally and laterally, while such distal protrusion may be omitted from the anchor (142). The net result of this configuration is that the one anchor (152) is oriented a greater distance distally relative to the other anchor (142) and the base portion (130). It should be understood that while this variation includes a distal offset relative to the anchor (152), in some variations such a distal offset may be omitted or may instead be used on both anchors (142, 152).

[0032] While each anchor (142, 152) in this variation is generally substantially similar in size, shape, and configuration, it should be understood that in other variations, each anchor (142, 152) may define a different configuration relative to the other anchor (152, 142). For example, in some variations, one anchor (142, 152) may be longer than the other anchor (152, 142). Additionally or alternatively, one anchor (142, 152) may include an anchor coil (146, 156) as described herein, while another anchor (152, 142) may omit a structure similar to the anchor coil (146, 156) or may use a different structure, such as a raised configuration, described in more detail below. Additionally or alternatively, one anchor (142, 152) may include additional features, such as spring features, compound angular extensions, and / or the like, while another anchor (152, 142) may exclude such features. Of course, various alternative configurations for each anchor (142, 152), individually or together, will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0033] 6-8 show examples of alternative marker elements (220) that may be incorporated into the marker (100) described above in addition to or instead of the marker element (120). The marker element (220) is generally substantially similar to the marker element (120) described above. For example, like the marker element (120), the marker element (220) of this variation is generally configured as a non-bioabsorbable marker that may be inherently radiopaque and / or echogenic. The marker element (220) may also be used in conjunction with a carrier (110) as described above, or alternatively, may be used without the carrier (110) to form a bare or clip-type marker (100).

[0034] Similar to marker element (120) above, marker element (220) of this variation includes a base portion (230) and a number of anchors (242, 252) (alternatively referred to as "outriggers"). Similar to base portion (130) above, base portion (230) of this variation can be disposed within carrier (110), while anchors (242, 252) can protrude distally from carrier (110). Base portion (230) can be configured similarly to base portion (130) in that base portion (230) can include one or more wires bent into a predetermined shape to provide a unique pattern that can enhance visualization under x-ray and / or ultrasound visualization. The particular shape used in this variation is a helical or spiral pattern, similar to the patterns described above with respect to base portion (130).

[0035] Each of the anchors (242, 252) in this variation is substantially similar to the anchors (142, 152) described above. For example, as with the anchors (142, 152) described above, each of the anchors (242, 252) in this variation can extend distally from the base portion (230) and protrude from at least a portion of the carrier (110). Similarly, the extension of each of the anchors (242, 252) can include a distal component and an outer component, such that the extension defines an angle of extension relative to the longitudinal axis of the base portion of about 55° in some variations, between 50° and 60° in some variations, and between about 45° and 65° in other variations. As with the anchors (142, 152) described above, the anchors (242, 252) in this variation can be similarly configured to move from a compressed configuration for use with a marker delivery device to an outwardly extending configuration described herein for engaging tissue.

[0036] Each anchor (242, 252) also includes a respective anchor coil (246, 256) disposed at a distal end of each anchor (242, 252), similar to the anchor coils (146, 156) described above. As also described above, each anchor coil (246, 256) is generally configured to engage tissue to maintain the marker (100) in place at the biopsy site, as well as to provide a unique pattern that enhances visualization under x-ray and / or ultrasound visualization. The particular shape of each anchor coil (246, 256) is substantially similar to the anchor coils (146, 156) described above, in that each anchor coil (246, 256) includes one or more loops of wire to form an eyelet-shaped configuration. As also described above, in other variations, each anchor coil (246, 256) may define other suitable shapes, such as a teardrop shape, a square or rectangular shape, a triangular shape, a spiral shape, a corkscrew shape, and / or others. Also as described above, in some variations, one or more of the anchor coils (246, 256) may be omitted and replaced with an end configuration having a non-coil shape, such as a raised, zigzag, or M-shaped bent wire section.

[0037] Unlike the marker element (120) described above, the marker element (220) of this variation includes a single wire configuration. For example, the base portion (230) of this variation defines a first wire portion (232) and a second wire portion (234). Both the first wire portion (232) and the second wire portion (234) are substantially similar to the first wire (132) and the second wire (134) described above in that they are two separate wire portions bent into a helical or spiral pattern to together define a double helix shape. However, instead of the wire portions (232, 234) terminating at an end (236) to define separate wire elements, the wire portions (232, 234) are integral with one another such that the entire marker element (220) forms a single, integral wire that is bent into the particular shape shown.

[0038] As best seen in FIGS. 7 and 8, the end portion (236) defines a generally curved circular or elliptical profile at the proximal end of the base portion (230). Specifically, the first wire portion (232) may be bent around the distal end of the base portion (230) and cross over the second wire portion (234). In other words, the end portion (236) forms a coil at the proximal end of the base portion (230). In some variations, the end portion (236) may include multiple coil loops, such as two, three, or more. While the end portion (236) defines a curved circular or elliptical profile in this variation, it should be understood that in other variations, various alternative shapes may be used. Suitable alternative shapes for the end portion (236) may include a rectangular or square shape, a triangular shape, a hexagonal shape, a diamond shape, a trapezoidal shape, and / or others.

[0039] 9 and 10 show an example of an alternative marker element (320) that may be incorporated into the marker (100) described above in addition to or instead of the marker elements (120, 220). The marker element (320) is generally substantially similar to the marker element (220) described above. For example, like the marker element (220), the marker element (320) of this variation is generally configured as a non-bioabsorbable marker that may be inherently radiopaque and / or echogenic. The marker element (320) may also be used in conjunction with a carrier (110) as described above, or alternatively, may be used without the carrier (110) to form a bare or clip-type marker (100).

[0040] Similar to marker element (220) above, marker element (320) of this variation includes a base portion (330) and a number of anchors (342, 352) (alternatively referred to as "outriggers"). Similar to base portion (230) above, base portion (330) of this variation can be disposed within carrier (110), while anchors (342, 352) can protrude distally from carrier (110). Base portion (330) can be configured similarly to base portion (230) in that base portion (330) can include one or more wires bent into a predetermined shape to provide a unique pattern that can enhance visualization under x-ray and / or ultrasound visualization. The particular shape used in this variation is a helical or spiral pattern, similar to the pattern described above with respect to base portion (230).

[0041] The marker element (320) of this variation includes a single wire configuration similar to the single wire configuration described above with respect to the marker element (220). As also described above, the base portion (330) defines a first wire portion (332) and a second wire portion (334) that intersect at an end (336) that defines a curved or other alternative shape. Also as also described above, both the first wire portion (332) and the second wire portion (334) may be bent into a twisted double helix or spiral shape that defines the shape of the base portion (330). It should be understood that while a single wire configuration is used in this variation to define the shape of the base portion (330), other variations may use a multiwire configuration similar to the multiwire configurations described herein for the base portion (130).

[0042] Each anchor (342, 352) in this variation is similar to the anchors (242, 252) described above. For example, as with the anchors (242, 252) described above, each anchor (342, 352) in this variation can extend distally from the base portion (330) and protrude from at least a portion of the carrier (110). Similarly, the extension of each anchor (342, 352) can include a distal component and an outer component, such that it defines an extension angle relative to the longitudinal axis of the base portion of about 55° in some variations, between 50° and 60° in some variations, and between about 45° and 65° in other variations. As with the anchors (242, 252) described above, the anchors (342, 352) in this variation can be similarly configured to move from a compressed configuration for use with a marker delivery device to an outwardly extending configuration described herein for engaging tissue.

[0043] Unlike the anchors (242, 252) described above, each anchor (342, 352) omits structure similar to the anchor coils (246, 256) described above. Instead, each anchor (342, 352) includes an anchor member (346, 356) disposed at a distal end of the respective anchor (342, 352). Each anchor member (346, 356) is generally configured to engage tissue to maintain the marker (100) in place at the biopsy site and to provide a unique pattern that enhances visualization under x-ray and / or ultrasound visualization. The shape of each anchor member (346, 356) is an irregular protuberance shape rather than the coil shape described above with respect to the anchor coils (246, 256). The particular irregular shape used in this variation of each anchor member (346, 356) is an M-shape or ridge shape. In some variations, this shape may be desired to provide increased engagement with tissue and / or a more distinctive profile under x-ray visualization. While an M-shape is used in this variation, it should be understood that in other variations, a variety of alternative shapes defining a series of ridges may be used. In other variations, one or more of the anchor members (346, 356) may instead include one or more loops of wire to form an eyelet-shaped configuration similar to the anchor coils (246, 256) described above.

[0044] B. Example of a marker element with cross visibility features 11-13 show an example of an alternative marker element (420) that may be incorporated into the marker (100) described above in addition to or instead of the marker elements (120, 220, 320). The marker element (320) is generally similar to the marker elements (120, 220, 320) described above. For example, like the marker elements (120, 220, 320), the marker element (420) of this variation is generally configured as a non-bioabsorbable marker that may be inherently radiopaque and / or echogenic. The marker element (420) may also be used in conjunction with a carrier (110) as described above, or alternatively, may be used without a carrier (110) to form a bare or clip-type marker (100).

[0045] Similar to marker elements (120, 220, 320) described above, marker element (420) of this variation includes a base portion (430) and a number of anchors (442, 452) (alternatively referred to as "outriggers"). Similar to base portions (130, 230, 330) described above, base portion (430) of this variation can be disposed within carrier (110), while anchors (442, 452) can protrude distally from carrier (110).

[0046] Each anchor (442, 452) in this variation is similar to anchors (142, 152, 242, 252) described above. For example, as with anchors (142, 152, 242, 252) described above, each anchor (442, 452) in this variation can extend distally from base portion (430) and protrude from at least a portion of carrier (110). Similarly, the extension of each anchor (442, 452) can include a distal component and an outer component such that it defines an extension angle relative to the longitudinal axis of the base portion of about 55° in some variations, between 50° and 60° in some variations, and between about 45° and 65° in other variations. Similar to the anchors (142, 152, 242, 252) described above, the anchors (442, 452) of this variation can similarly be configured to move from a compressed configuration for use with a marker delivery device to an outwardly extending configuration described herein for engaging tissue.

[0047] Each anchor (442, 452) also includes a respective anchor coil (446, 456) disposed at a distal end of each anchor (442, 452), similar to the anchor coils (146, 156, 246, 256) described above. As also described above, each anchor coil (446, 456) is generally configured to engage tissue to maintain the marker (100) in place at the biopsy site, as well as to provide a unique pattern that enhances visualization under x-ray and / or ultrasound visualization. The particular shape of each anchor coil (446, 456) is substantially similar to the anchor coils (146, 156, 246, 256) described above in that each anchor coil (446, 456) includes one or more loops of wire to form an eyelet-shaped configuration. As also described above, in other variations, each anchor coil (446, 456) may define other suitable shapes, such as a teardrop shape, a square or rectangular shape, a triangular shape, a spiral shape, a corkscrew shape, and / or the like. Also, as also described above, in some variations, one or more anchor coils (446, 456) may be omitted and replaced with an end configuration having a non-coiled shape, such as a ridged, zigzag, or M-shaped bent wire section, similar to the configurations described above with respect to anchor members (346, 356) of marker element (320).

[0048] The marker element (420) of this variation includes a single wire configuration similar to the single wire configurations described above with respect to the marker elements (220, 320). As also described above, the base portion (430) defines a first wire portion (432) and a second wire portion (434) that intersect at an end (436) that defines a curved shape or other alternative shape. Also as also described above, both the first wire portion (432) and the second wire portion (434) may be bent into a predetermined shape that defines the shape of the base portion (430). It should be understood that while a single wire configuration is used in this variation to define the shape of the base portion (430), other variations may use a multiwire configuration similar to the multiwire configurations described herein for the base portion (130).

[0049] End (436) is similar to ends (236, 336) described above in that end (436) defines a curved shape, but end (436) differs from ends (236, 336) described above in that end (436) includes multiple loops or multiple bends. In particular, as best seen in FIG. 12, wire portions (432, 434) are bent toward one another to define multiple coils at end (436). Such a multiple coil configuration may be desirable in some variations to provide additional structural stability to marker element (420). While two coils are defined in this variation, other variations may use other suitable numbers of coils, such as two or more or one similar to the configurations described above for ends (236, 336).

[0050] Unlike the base portion (130, 230, 330) described above, the base portion (430) defines a different shape relative to the helical configuration described above. Specifically, each of the first wire portion (432) and the second wire portion (434) in this variation may be bent to define an intersecting pattern. Such an intersecting pattern may be desirable in some variations to define a unique appearance of the base portion (430) under X-ray visualization relative to the shapes described above for the base portion (130, 230, 330). The intersecting pattern defined in this example specifically includes each wire portion (432, 434) first flaring outward in an opposite direction relative to the other wire portion (432, 434). The wire portions (432, 434) then extend parallel to each other for a predetermined length before converging inward to intersect with each other. In this configuration, the wire portions (432, 434) together define a generally rounded rectangular configuration when viewed from the side as shown in FIG.

[0051] C. Example of a marker element with linear visualization features 14-16 show an example of an alternative marker element (520) that may be incorporated into the marker (100) described above in addition to or instead of the marker elements (120, 220, 320, 420). The marker element (420) is generally similar to the marker elements (120, 220, 320, 420) described above. For example, like the marker elements (120, 220, 320, 420), the marker element (520) of this variation is generally configured as a non-bioabsorbable marker that may be inherently radiopaque and / or echogenic. The marker element (520) may also be used in conjunction with a carrier (110) as described above, or alternatively, may be used without a carrier (110) to form a bare or clip-type marker (100).

[0052] Similar to marker elements (120, 220, 320, 420) described above, marker element (520) of this variation includes a base portion (530) and a number of anchors (542, 552) (alternatively referred to as "outriggers"). Similar to base portions (130, 230, 330, 430) described above, base portion (530) of this variation can be disposed within carrier (110), while anchors (542, 552) can protrude distally from carrier (110).

[0053] Each anchor (542, 552) in this variation is similar to the anchors (142, 152, 242, 252, 442, 452) described above. For example, as with the anchors (142, 152, 242, 252, 442, 452) described above, each anchor (542, 552) in this variation can extend distally from the base portion (530) and protrude from at least a portion of the carrier (110). Similarly, the extension of each anchor (542, 552) can include a distal component and an outer component such that it defines an extension angle relative to the longitudinal axis of the base portion of about 55° in some variations, between 50° and 60° in some variations, and between about 45° and 65° in other variations. Similar to the anchors (142, 152, 242, 252, 442, 452) described above, the anchors (542, 552) of this variation can similarly be configured to move from a compressed configuration for use with a marker delivery device to an outwardly extending configuration described herein for engaging tissue.

[0054] Each anchor (542, 552) also includes a respective anchor coil (546, 556) disposed at a distal end of each anchor (542, 552), similar to the anchor coils (146, 156, 246, 256, 446, 456) described above. As also described above, each anchor coil (546, 556) is generally configured to engage tissue to maintain the marker (100) in place at the biopsy site, as well as to provide a unique pattern that enhances visualization under x-ray and / or ultrasound visualization. The particular shape of each anchor coil (546, 556) is substantially similar to the anchor coils (146, 156, 246, 256, 446, 456) described above in that each anchor coil (546, 556) includes one or more loops of wire to form an eyelet-shaped configuration. As also described above, in other variations, each anchor coil (546, 556) may define other suitable shapes, such as a teardrop shape, a square or rectangular shape, a triangular shape, a spiral shape, a corkscrew shape, and / or the like. Also, as also described above, in some variations, one or more anchor coils (546, 556) may be omitted and replaced with an end configuration having a non-coiled shape, such as a raised, zigzag, or M-shaped bent wire section, similar to the configurations described above with respect to anchor members (346, 356) of marker element (320).

[0055] The marker element (520) of this variation includes a multi-wire configuration similar to the multi-wire configuration described above with respect to the marker element (120). As above, the base portion (530) defines a first wire (532) and a second wire (534) that extend to, but remain separate at, the end (536). Also as described above, both the first wire (532) and the second wire (534) may be bent into a predetermined shape that defines the shape of the base portion (530). It should be understood that while a multi-wire configuration is used in this variation to define the shape of the base portion (530), other variations may use a single wire configuration for the base portion (230, 330, 430) similar to the single wire configuration described herein.

[0056] End portion (536) is similar to end portion (136) described above in that end portion (536) includes a bend, with the proximal ends of each of first wire (532) and second wire (534) being bent in different or opposite directions. However, unlike end portion (136) described above, each of first wire (532) and second wire (534) is bent to form a first end coil (538) and a second end coil (540), respectively. Each end coil (538, 540) defines a loop of wire or coil that defines the curved shape of end portion (536). Each end coil (538, 540) is also oriented about a parallel plane such that end coils (538, 540) may be arranged in a side-by-side but offset configuration. In this variation, each end coil (538, 540) includes a single coil, although it should be understood that in some variations, the first end coil (538), the second end coil (540), or both, may include two or more coils.

[0057] Unlike the base portion (130, 230, 330) described above, the base portion (530) defines a different shape to the helical configuration described above. Specifically, each of the first wire (532) and the second wire (534) in this variation may be bent to define a generally linear pattern. In other words, the first wire (532) and the second wire (534) may together define a profile having two parallel lines, as seen in Figures 15 and 16. Furthermore, the first wire (532) and the second wire (534) may be offset relative to each other in one or more lateral directions. As a result, the wires (532, 534) may be completely separate or not in contact with each other. In this configuration, the specific relative positions of the first wire (532) and the second wire (534) may be held in place using the carrier (110) as opposed to a physical connection between the wires (532, 534). In other words, the carrier (110) may, in some variations, act as a fastener to hold the wires (532, 534) in place. Such a pattern may, in some variations, be desirable to define a distinctive appearance of the base portion (530) under x-ray visualization relative to the shapes described above for the base portions (130, 230, 330, 430).

[0058] II. Exemplary Uses of Markers to Mark Biopsy Sites 17A-17C show an embodiment of a procedure for percutaneously marking a biopsy cavity (1010) with surrounding tissue (1030). For example, as seen in FIG. 17A, a marker (1000) can be initially placed in the biopsy cavity (10) to facilitate repositioning of the biopsy site. While the marker (1000) shown herein includes certain characteristics, it should be understood that in some variations, the marker (100) described above can be used in conjunction with the biopsy cavity (1010) and surrounding tissue (1030). As with the marker (100) described above, the marker (1000) can include a carrier (1200) similar to the carrier (120) and a marker element (1012) similar to the marker elements (120, 220, 320, 420, 520). Similar to the carrier (120) described above, the carrier (1120) generally includes a bioabsorbable marker material (1022). Thus, the carrier (1120) is generally configured to be absorbed into the patient's body after placement of the marker (1000) within the biopsy cavity (1010). In some variations, the carrier (1120) may include a plurality of microbubbles to enhance visualization of the carrier (1120) under ultrasound. As described in more detail below, the marker material (1022) is generally bioabsorbable, such that the marker material (1022) may generally be absorbed into the patient's tissue over time. In this variation, the marker material (1022) includes a hydrogel that is initially in a dehydrated state. While this variation uses a hydrogel, it should be understood that in other variations, the marker material (1022) may include other known bioabsorbable materials.

[0059] In this variation, the marker (1000) further includes a marker element (1012) that is generally not bioabsorbable. Although not shown, it should be understood that in some variations, the marker element (1012) may include one or more aspects of the marker elements (120, 220, 320, 420, 520) described above, such as aspects of the base portion (130, 230, 330, 430, 530) and / or anchor (142, 152, 242, 252, 342, 352, 442, 452, 542, 552). Similar to the marker elements (120, 220, 320, 420, 520) described above, the marker element (1012) may include a radiopaque or echogenic marker embedded within the bioabsorbable marker material (1022) of the carrier (1120). For example, the marker element (1012) may comprise a metal, a hard plastic, or other radiopaque or hyperechoic material known to one of ordinary skill in the art in view of the teachings herein. In other variations, the marker (1000) may be formed without the marker element (1012). In yet other variations, the marker (1000) may be formed with only the marker element (1012) such that the carrier (1120) is omitted and the marker element (1012) is in a "bare" form. In other words, in some variations, the marker (1000) is formed with only the marker element (1012) as a bare clip.

[0060] The marker material (1022) is generally expandable when placed in the patient's body at the biopsy cavity (1010) at the biopsy site. As shown in Figures 17B and 17C, the initially dehydrated marker material (1022) may absorb fluid from the surrounding tissue (1030) into which it is inserted. In response to this fluid absorption, the maker material (1022) expands, thereby allowing the carrier (1120) to fill the biopsy cavity (1010) formed at the biopsy site by the removal of the tissue sample during the biopsy procedure. Biodegradable materials may be particularly suitable in applications where it is desired that the implanted material be completely or partially replaced by natural tissue growth over time. Correspondingly, biocompatibility is ensured and the natural mechanical parameters of the tissue are substantially restored to those of the pre-injury state.

[0061] The marker (1000) may be inserted into the body either surgically through an opening in the body cavity (1030) or in a minimally invasive procedure using a device such as a catheter, introducer, or similar type of insertion device. The marker (1000) 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 a physician to identify, locate, and monitor the biopsy cavity site over a period of time via the marker (1000).

[0062] The marker (1000) of this variant is large enough to be easily visible to the clinician, for example under X-ray or ultrasound observation, but small enough to be deployed percutaneously inside the biopsy cavity and not cause any difficulty to the patient. Although the variant is described in the context of breast tissue treatment and diagnosis, the embodiments presented herein may be used for markers in any internal tissue, for example breast tissue, lung tissue, prostate tissue, lymphatic tissue, etc.

[0063] Hydration of the marker material (1022) of the carrier (1120) by the natural moisture of the surrounding tissue causes the polymer to swell, thus minimizing the risk of migration. The growing hydrogel-based marker material (1022) centers the marker (1000) in the biopsy cavity as it grows. As the hydrogel swells, the naturally occurring moisture present from the surrounding tissue allows for increased sound transmission due to hydration, resulting in a more hypoechoic appearance that may be easier to visualize on follow-up ultrasound examinations.

[0064] The hydrated hydrogel marker material (1022) of the carrier (1120) may also be used to frame the permanent marker (1012). The hypoechoic nature of the hydrated marker material (1022) allows for ultrasound visibility of the permanent marker (102) within the hydrogel hydrated marker material (1022) since the permanent marker (1012) is contoured as a specular reflector within the hypoechoic hydrated marker, which has a non-reflective substrate similar to water.

[0065] III. Exemplary Marker Delivery Devices In some variations, it may be desirable to deploy any one or more of the above markers (100, 1000) within the biopsy cavity (1030) using a particular marker delivery device. For example, Figures 18 and 19 show an exemplary marker delivery device (1050) including an elongated outer cannula (1062) having a marker exit port, such as a lateral opening (1064), formed adjacent the distal end of the cannula (1062) but spaced proximally.

[0066] Although the marker delivery device (1050) is shown herein as being used with the marker (3000), it should be understood that in other applications, the marker delivery device (1050) may readily be used with any one or more of the markers (100, 1000) described herein. Additionally, in some applications, the marker delivery device (1050) may comprise a marker kit including several variants of the marker (100), and an operator may select one or more of such variants of the marker (100) for use with the marker delivery device (1050). For example, for use with such a kit, several variants of the marker (100) having one or more of the marker elements (120, 220, 320, 420, 520) described above may be included in the kit. The operator may then select a particular variant of the marker (100), or a combination of various variants of the marker (100), for use with the marker delivery device (1050). Such use may be desirable to provide an operator-preferred distinctive appearance of marker (100) for later identification of a particular biopsy site. Such operator preference may be particularly desirable in situations where there are multiple biopsy sites in a single patient, either from a single procedure or multiple procedures over time.

[0067] A grip (1066) can be provided at a proximal end of the cannula (1062). A push rod (1068) can be provided, extending coaxially through the cannula (1062), configured to translate within the cannula (1062) to displace one or more markers through the side opening (1064) (see FIG. 19). The rod (1068) can be sufficiently stiff upon compression to push the markers out of the lumen of the cannula (1062) through the opening (1064), yet relatively flexible to bend. A plunger (1070) is coupled at the proximal end of the rod (1068) to push the rod (1068) distally within the cannula (1062) to deploy the markers from the cannula (1062).

[0068] A user can grasp grip (1066) with two fingers and use the thumb of the same hand to depress plunger (1070), thereby allowing marker delivery device (1060) to be operated with one hand of the user. A spring (not shown) or other feature can be provided around rod (1068) to bias rod (1068) proximally relative to grip (1066) and cannula (1062).

[0069] 19 shows a cross-sectional view of the distal portion of a marker delivery device (1060). As can be seen, a biopsy marker (3000), similar to the markers (100, 1000) described above, is disposed within the lumen (1065) of the cannula (1062). In this variation, the marker (3000) includes a biodegradable or other absorbable marker material (3006), such as a generally cylindrically shaped body of collagen, hydrogel, or the like, and a metallic, generally radiopaque permanent marker or marker element (3010) (shown in phantom) disposed within or otherwise carried by the marker material (3006).

[0070] The cannula (1062) may be formed of any suitable metallic or non-metallic material. In some variations, the cannula (1062) 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. The cannula (1062) may be formed from PEBAX and may be substantially transparent to visible light and x-rays.

[0071] The side opening (1064) may be formed by cutting away a portion of the wall of the cannula (1062). The side opening (1064) communicates with the lumen of the cannula (1062). The side opening (1064) may extend axially (in a direction parallel to the axis of the cavity (165)) from a proximal open end (1064A) to a distal open end (1064B), as shown in FIG.

[0072] In this variation, a distal tip (1072) extends from the distal end of the cannula (1062) and is rounded as shown in FIG. 19. The distal end of the cannula (1062) is closed by an integral end piece (1071) with a portion of the end piece (1071) extending into a portion of the cannula (1062). The end piece (1071) may be a molded or cast component. The end piece (1071) includes a tip (1072), a ramp (2010) having a ramp face (2012), and a marker engaging element (2040). The ramp face (2012) serves to direct the marker (3000) from the lumen of the cannula (1062) through the side opening (1064). Marker engaging element (2040) serves to retain marker (3000) in cannula (1062) until the user intends to deploy marker (3000).

[0073] The marker engaging element (2040) is disposed within the cannula (1062), with at least a portion of the marker engaging element (2040) disposed distal to the proximal end (1064A) of the side opening (1064). The marker engaging element (2040) extends along a portion of the floor of the cannula (1062) below the opening (1064), such that the marker engaging element (2040) reinforces the portion of the cannula (1062) where the opening (1064) is formed. For example, as shown in FIG. 19, by placing the marker engaging element (2040) below the opening (1064), the element (2040) helps reinforce the cannula (1062) in the area where the wall of the cannula (1062) is cut to form the opening (1064). As shown in FIG. 19, the marker engagement element (2040) extends from the proximal-most portion of the ramp face (2012) and does not extend proximal to the side opening (1064), although in other embodiments, a portion of the element (2040) may extend proximal to the opening (1064).

[0074] As shown in Figure 19, the marker engaging element (2040) is in the form of a step having a generally uniform thickness (T) along the axial length of the element (2040), except that the element (2040) has a tapered proximal end (2042). The tapered proximal end (2042) forms an included angle with the longitudinal axis of the cannula (1062) of approximately 45 degrees (included angle with the horizontal in Figure 19), and the ramp surface (2012) forms an included angle with the longitudinal axis of the cannula (1062) of approximately 30 degrees. Of course, any number of other suitable angles may be used.

[0075] 19, the upwardly facing surface (2044) (the opening (1064) facing the surface) of the marker engaging element (2040) extends distally to the contact ramp surface (2012) such that there is no space or gap between the surface (2044) and the ramp surface (2012). Such an arrangement is advantageous in reducing the likelihood that the marker (3000) may become stuck between the marker engaging element (2040) and the ramp (2012) as it moves past the marker engaging element (2040). In some variations, the marker engaging element (2040), ramp (2010), and / or tip (1072) are formed from or include a material that is relatively more radiopaque than the walls of the cannula (1062). For example, if the element (2040), ramp (2010), and tip (1072) are formed as an integral end piece (1071), the end piece (1071) may include a radiopaque additive, such as barium sulfate. For example, the end piece (1071) may be a PEBAX molded component, with about 20 weight percent barium sulfate added to the molten PEBAX mold composition. The relatively radiopaque marker engaging element (2040), ramp (2010), and tip (1072) may be useful in distinguishing the location of those components using radiographic imaging. Also, if the ramp (2010) and / or engaging element (2040) steps are positioned in association with the opening (1064), the addition of radiopaque material may help identify the location of the opening (1064) and the location of the marker (3000) relative to the opening (1064) before, during, or after the marker (3000) is deployed.

[0076] Referring to FIG. 20, a marker delivery device (1060) is used to deploy a marker (3000) to mark a biopsy location within a patient. In FIG. 20, a cannula biopsy needle (4000) is shown having a closed distal end with a piercing tip (4002) and a lateral tissue receiving aperture (4014). The marker delivery device (1060) is introduced to the biopsy site through the biopsy needle (4000), which may be the same needle (4000) used to collect tissue samples from the biopsy site. The biopsy needle (4000) may be of the type used in a single insertion, multiple sample vacuum assisted biopsy device. Several such biopsy devices are disclosed in the various patents and patent applications referenced and incorporated herein by reference, although other biopsy devices may be used.

[0077] FIG. 20 shows the distal end of the marker delivery device 1060 disposed within the needle 4000. The needle 4000 may be placed into tissue and a biopsy sample may be obtained through the side aperture 4014, thereby providing a biopsy cavity adjacent the side aperture 4014. The tissue sample may then be obtained and transferred proximally through the needle 4000, and the marker delivery device 1060 may then be inserted into the proximal opening of the needle 4000 without removing the needle 4000 from the patient's tissue. In FIG. 20, the needle 4000 and marker delivery device 1060 are positioned such that the opening 1064 of the cannula 1062 and the side aperture 4014 of the needle 4000 are substantially aligned axially and circumferentially. Next, with the marker delivery device (1060) and needle (4000) so positioned at the biopsy site, the push rod (1068) is advanced to deploy the marker (3000) above the ramp face (2012), through the opening (1064), and then through the side aperture (4014) and into the biopsy cavity.

[0078] IV. Exemplary Combinations The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any "claims" that may be presented at any time in this application or in any subsequent application following this application. No disclaimers are intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features that are referred to in the examples below. Thus, unless expressly indicated otherwise later by the inventor or by the intended inventor's successors, etc., none of the aspects or features referred to below should be considered critical. If any "claims" are presented in this application or in any subsequent application related to this application that include additional features beyond those referred to below, those additional features should not be presumed to have been added for any reason related to patentability.

[0079] Example 1 1. A biopsy site marker comprising: a carrier; and a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first anchor and the second anchor configured to move relative to the base portion to engage tissue at a biopsy site, the base portion defining a plurality of curved portions disposed between the first anchor, the second anchor, and a curved proximal end, the plurality of curved portions configured to define a distinctive appearance under x-ray visualization.

[0080] Example 2 The marker of example 1, wherein the first anchor and the second anchor extend laterally from the base portion at an angle relative to a longitudinal axis defined by the carrier.

[0081] Example 3 The marker of example 2, wherein the multiple curved portions are oriented along the longitudinal axis defined by the carrier.

[0082] Example 4 A marker described in any of Examples 1 to 3, wherein the hydrogel marker material is configured to expand in the presence of moisture, and the first anchor and the second anchor are configured to increase engagement of the first anchor and the second anchor with tissue in response to expansion of the hydrogel marker material.

[0083] Example 5 A marker described in any of Examples 1 to 4, wherein the first anchor and the second anchor each include an anchor member, and the anchor member is disposed at an outer end of each of the first anchor and the second anchor.

[0084] Example 6 The marker of example 5, wherein the anchor member comprises one or more coils.

[0085] Example 7 The marker of example 5, wherein the anchor member defines a plurality of ridges.

[0086] Example 8 A marker described in any of Examples 1 to 7, wherein the base portion defines a spiral portion extending from the proximal end to the first anchor and the second anchor, and the spiral portion defines the plurality of curved portions.

[0087] Example 9 The marker of Example 8, wherein the helical portion comprises two wire portions twisted together to form a double helix.

[0088] Example 10 The marker of Example 9, wherein the two wire portions are integrally connected at a proximal end.

[0089] Example 11 The marker of example 9, wherein the two wire portions are separate, discrete elements.

[0090] Example 12 A marker as described in any of Examples 1 to 7, wherein the base portion defines a first wire portion and a second wire portion, the first wire portion and the second wire portion being bent in opposite directions such that the first wire portion and the second wire portion cross each other at two or more points, defining at least a portion of a curved portion of the plurality of curved portions.

[0091] Example 13 13. The marker of claim 12, wherein the first wire portion and the second wire portion each define a straight portion, and the first wire portion and the second wire portion extend parallel to one another within the straight portions.

[0092] Example 14 A marker as described in Example 12 or 13, wherein the first wire portion and the second wire portion are joined at the proximal end, the proximal end defining an end coil defining one or more wire loops.

[0093] Example 15 A marker as described in Example 12 or 13, wherein the first wire portion and the second wire portion extend from the first anchor and the second anchor toward the proximal end, the first wire portion and the second wire portion curve away from each other at the proximal end, and the first wire portion and the second wire portion are separate discrete elements.

[0094] Example 16 1. A biopsy site marker comprising: a carrier; and a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier and defining a first wire and a second wire, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first wire defining a first shaped portion and the second wire defining a second shaped portion, the first shaped portion defining a helical shape extending along a longitudinal axis defined by the base portion.

[0095] Example 17 17. The biopsy site marker of example 16, wherein the second shaped portion of the second wire defines a shape that corresponds to the first shaped portion of the first wire.

[0096] Example 18 The biopsy site marker of Example 16, wherein the second shaped portion of the second wire defines a substantially straight shape.

[0097] Example 19 The biopsy site marker of any one of Examples 16 to 18, wherein the first wire is integral with the second wire.

[0098] Example 20 11. A kit for marking a biopsy site comprising: a marker delivery device including a handpiece, a cannula extending from the handpiece, the cannula defining a marker port, and a push rod configured to translate within a portion of the cannula; and a plurality of markers, each marker of the plurality of markers configured to be received within the cannula of the marker delivery device for deployment through the marker port via the push rod, each marker including a carrier, and a marker element defining a base portion and one or more anchors, a portion of the marker element disposed within at least a portion of the carrier, wherein the base portion of each marker element of the plurality of markers defines a unique shape relative to each other base portion, and at least one base portion defines a helical profile.

[0099] Example 21 The kit of Example 20, wherein each anchor portion of the plurality of anchor portions is configured to move from each adjacent anchor portion to secure a respective marker to tissue.

[0100] Example 22 The kit of Example 20 or 21, wherein the plurality of markers includes a first marker having a first marker element defining a first base portion, a second marker having a second marker element defining a second base portion, and a third marker having a third marker element defining a third base portion, each of the first base portion, the second base portion, and the third base portion defining a different shape relative to the other base portions.

[0101] Example 23 The kit of example 22, wherein the first base portion defines a spiral shape, the second base portion defines a cross shape, and the third base portion defines a straight shape.

[0102] Example 24 The kit of Example 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires that together define the shape of the respective base portion.

[0103] Example 25 The kit of Example 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, the two wires being integrally connected at a proximal end of the respective base portion.

[0104] Example 26 The kit of Example 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, and the two wires of one or more of the first base portion, the second base portion, or the third base portion are separated from each other and held in place by the carrier.

[0105] conclusion It should be recognized that any patent, publication, or other disclosure material referred to as being incorporated herein in whole or in part by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, 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, referred to as being incorporated herein by reference but which conflicts with existing definitions, statements, or other disclosure material set forth herein, is incorporated only to the extent that no conflict arises between the incorporated material and the existing disclosure material.

[0106] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Although some of such potential modifications have been mentioned, others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are illustrative and not required. Thus, it is understood that the scope of the present invention should be considered in conjunction with the following "claims" and is not limited to the details of structure and operation shown and described in the specification and drawings.

[0107] [Embodiment] (1) A biopsy site marker, comprising: Carrier, and 1. The biopsy site marker comprising: a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first anchor and the second anchor configured to move relative to the base portion to engage tissue at a biopsy site, the base portion defining a plurality of curved portions disposed between the first anchor, the second anchor, and a curved proximal end, the plurality of curved portions configured to define a distinctive appearance under x-ray visualization. (2) A marker as described in embodiment 1, wherein the first anchor and the second anchor extend laterally from the base portion at an angle relative to a longitudinal axis defined by the carrier. (3) A marker as described in embodiment 2, wherein the multiple curved portions are oriented along the longitudinal axis defined by the carrier. (4) A marker described in any of embodiments 1 to 3, wherein the carrier comprises a hydrogel marker material configured to expand in the presence of moisture, and the first anchor and the second anchor are configured to increase engagement of the first anchor and the second anchor with tissue in response to expansion of the hydrogel marker material. (5) A marker described in any one of embodiments 1 to 4, wherein the first anchor and the second anchor each include an anchor member, and the anchor member is disposed at an outer end of each of the first anchor and the second anchor.

[0108] (6) The marker of embodiment 5, wherein the anchor member comprises one or more coils. (7) A marker as described in embodiment 5, wherein the anchor member defines a plurality of ridges. (8) A marker described in any one of embodiments 1 to 7, wherein the base portion defines a spiral portion extending from the proximal end to the first anchor and the second anchor, and the spiral portion defines the plurality of curved portions. (9) The marker of embodiment 8, wherein the helical portion comprises two wire portions twisted together to form a double helix. (10) A marker as described in embodiment 9, wherein the two wire portions are integrally connected at the proximal end.

[0109] (11) The marker of embodiment 9, wherein the two wire portions are separate, discrete elements. (12) A marker described in any one of embodiments 1 to 7, wherein the base portion defines a first wire portion and a second wire portion, the first wire portion and the second wire portion being bent in opposite directions such that the first wire portion and the second wire portion cross each other at two or more points, defining at least a portion of a curved portion of the plurality of curved portions. (13) The marker of embodiment 12, wherein the first wire portion and the second wire portion each define a straight portion, and the first wire portion and the second wire portion extend parallel to each other within the straight portions. (14) The marker of embodiment 12 or 13, wherein the first wire portion and the second wire portion are joined at the proximal end, the proximal end defining an end coil defining one or more wire loops. (15) The marker of embodiment 12 or 13, wherein the first wire portion and the second wire portion extend from the first anchor and the second anchor toward the proximal end, the first wire portion and the second wire portion curve away from each other at the proximal end, and the first wire portion and the second wire portion are separate, discrete elements.

[0110] (16) A biopsy site marker, comprising: Carrier, and 1. The biopsy site marker comprising: a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier and defining a first wire and a second wire, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first wire defining a first shaped portion and the second wire defining a second shaped portion, the first shaped portion defining a helical shape extending along a longitudinal axis defined by the base portion. (17) The biopsy site marker of claim 16, wherein the second shaped portion of the second wire defines a shape corresponding to the first shaped portion of the first wire. (18) The biopsy site marker of embodiment 16, wherein the second shaped portion of the second wire defines a substantially straight shape. (19) The biopsy site marker of any one of embodiments 16 to 18, wherein the first wire is integral with the second wire. (20) A kit for marking a biopsy site, comprising: (a) a marker delivery device, (i) a handpiece; (ii) a cannula extending from the handpiece, the cannula defining a marker port; and (iii) a push rod configured to translate within a portion of the cannula; and (b) a plurality of markers, each marker of the plurality of markers configured to be received within the cannula of the marker delivery device for deployment through the marker port via the push rod, each marker comprising: (i) the carrier; and (ii) the plurality of markers includes a marker element defining a base portion and one or more anchors, a portion of the marker element disposed within at least a portion of the carrier; The kit, wherein the base portion of each marker element of the plurality of markers defines a unique shape relative to each other base portion, and at least one base portion defines a helical profile.

[0111] (21) The kit of embodiment 20, wherein each anchor portion of the plurality of anchor portions is configured to move from each adjacent anchor portion to fix a respective marker to tissue. (22) The kit of embodiment 20 or 21, wherein the plurality of markers includes a first marker having a first marker element defining a first base portion, a second marker having a second marker element defining a second base portion, and a third marker having a third marker element defining a third base portion, each of the first base portion, the second base portion, and the third base portion defining a different shape relative to the other base portions. (23) The kit of embodiment 22, wherein the first base portion defines a spiral shape, the second base portion defines a cross shape, and the third base portion defines a straight shape. (24) The kit of embodiment 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires that together define the shape of the respective base portion. (25) The kit of embodiment 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, the two wires being integrally connected at a proximal end of the respective base portion.

[0112] (26) The kit of embodiment 22 or 23, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, and the two wires of one or more of the first base portion, the second base portion, or the third base portion are separated from each other and held in place by the carrier.

Claims

1. A biopsy site marker comprising: Carrier, and 1. The biopsy site marker comprising: a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first anchor and the second anchor configured to move relative to the base portion to engage tissue at a biopsy site, the base portion defining a plurality of curved portions disposed between the first anchor, the second anchor, and a curved proximal end, the plurality of curved portions configured to define a distinctive appearance under x-ray visualization.

2. The marker of claim 1 , wherein the first anchor and the second anchor extend laterally from the base portion at an angle relative to a longitudinal axis defined by the carrier.

3. The marker of claim 2 , wherein the plurality of curved portions are oriented along the longitudinal axis defined by the carrier.

4. A marker according to any one of claims 1 to 3, wherein the carrier comprises a hydrogel marker material configured to expand in the presence of moisture, and the first anchor and the second anchor are configured to increase engagement of the first anchor and the second anchor with tissue in response to expansion of the hydrogel marker material.

5. The marker of claim 1 , wherein the first anchor and the second anchor each include an anchor member, the anchor member disposed at an outer end of each of the first anchor and the second anchor.

6. The marker of claim 5 , wherein the anchor member comprises one or more coils.

7. The marker of claim 5 , wherein the anchor member defines a plurality of ridges.

8. The marker of claim 1 , wherein the base portion defines a helical portion extending from the proximal end to the first anchor and the second anchor, the helical portion defining the plurality of curved portions.

9. The marker of claim 8 , wherein the helical portion comprises two wire portions twisted together to form a double helix.

10. The marker of claim 9 , wherein the two wire portions are connected together at a proximal end.

11. The marker of claim 9 , wherein the two wire portions are separate, discrete elements.

12. 2. The marker of claim 1, wherein the base portion defines a first wire portion and a second wire portion, the first wire portion and the second wire portion being bent in opposite directions such that the first wire portion and the second wire portion cross each other at two or more points to define at least a portion of a curved portion of the plurality of curved portions.

13. 13. The marker of claim 12, wherein the first wire portion and the second wire portion each define a straight portion, and the first wire portion and the second wire portion extend parallel to one another within the straight portions.

14. 14. The marker of claim 12 or 13, wherein the first wire portion and the second wire portion are joined at the proximal end, the proximal end defining an end coil that defines one or more wire loops.

15. 14. The marker of claim 12 or 13, wherein the first and second wire portions extend from the first and second anchors toward the proximal end, the first and second wire portions curve away from each other at the proximal end, and the first and second wire portions are separate, discrete elements.

16. A biopsy site marker comprising: Carrier, and 1. The biopsy site marker comprising: a marker element including a base portion, a first anchor, and a second anchor, the base portion being at least partially disposed within the carrier and defining a first wire and a second wire, at least a portion of the first anchor and the second anchor extending laterally and outwardly away from the base portion, the first wire defining a first shaped portion and the second wire defining a second shaped portion, the first shaped portion defining a helical shape extending along a longitudinal axis defined by the base portion.

17. 17. The biopsy site marker of claim 16, wherein the second shaped portion of the second wire defines a shape corresponding to the first shaped portion of the first wire.

18. 17. The biopsy site marker of claim 16, wherein the second shaped portion of the second wire defines a substantially straight shape.

19. The biopsy site marker of any of claims 16 to 18, wherein the first wire is integral with the second wire.

20. 1. A kit for marking a biopsy site, comprising: (a) a marker delivery device, comprising: (i) a handpiece; (ii) a cannula extending from the handpiece, the cannula defining a marker port; and (iii) a push rod configured to translate within a portion of the cannula; and (b) a plurality of markers, each marker of the plurality of markers configured to be received within the cannula of the marker delivery device for deployment through the marker port via the push rod, each marker comprising: (i) a carrier; and (ii) the plurality of markers including a marker element defining a base portion and one or more anchors, a portion of the marker element disposed within at least a portion of the carrier; The kit, wherein the base portion of each marker element of the plurality of markers defines a unique shape relative to each other base portion, and at least one base portion defines a helical profile.

21. 21. The kit of claim 20, wherein each anchor portion of the plurality of anchor portions is configured to move from each adjacent anchor portion to secure a respective marker to tissue.

22. 22. The kit of claim 20 or 21, wherein the plurality of markers includes a first marker having a first marker element defining a first base portion, a second marker having a second marker element defining a second base portion, and a third marker having a third marker element defining a third base portion, each of the first base portion, the second base portion, and the third base portion defining a different shape relative to the other base portions.

23. 23. The kit of claim 22, wherein the first base portion defines a helical shape, the second base portion defines a cross shape, and the third base portion defines a linear shape.

24. 23. The kit of claim 22, wherein the first base portion, the second base portion, and the third base portion each include two wires that together define the shape of the respective base portion.

25. 23. The kit of claim 22, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, the two wires being integrally connected at a proximal end of the respective base portion.

26. 23. The kit of claim 22, wherein each of the first base portion, the second base portion, and the third base portion includes two wires, and the two wires of one or more of the first base portion, the second base portion, or the third base portion are separated from each other and held in place by the carrier.

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