Biopsy site marker with movable portion

Abstract

A biopsy site marker includes a marker element. The marker element includes a base portion and an anchor portion. The anchor portion extends from the base portion. The anchor portion includes a plurality of arms. One or more arms of the plurality of arms are configured to transition from a pre-deployment configuration to a post-deployment configuration in response to heat. When in the deployed configuration, each transformed arm of the plurality of arms extends outwardly from a longitudinal axis defined by the marker element.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 398,338, filed on August 16, 2022, entitled “Biopsy Site Marker Having Movable Portions,” the disclosure of which is incorporated herein by reference. Background Art

[0003] A breast biopsy may be performed because of an abnormal mammogram or a palpable abnormality. Biopsies can include surgical excisional biopsies and stereotactic and ultrasound-guided needle breast biopsies. In the case of an image-guided biopsy, a radiologist or other physician may obtain a small sample of the irregular tissue for laboratory analysis. If the biopsy proves to be malignant, additional surgery (e.g., a lumpectomy or mastectomy) may be required. In the case of a needle biopsy, the patient may return to the radiologist a day or more later, and the biopsy site (lesion) may need to be relocated in preparation for surgery. Imaging systems such as ultrasound, magnetic resonance imaging (MRI), or x-rays can be used to locate the biopsy site. To assist in relocating the biopsy site, markers may be placed during the biopsy.

[0004] The use of markers for marking the location for removal of biopsy tissue after a breast biopsy is described in the following U.S. patents: U.S. 6,083,524, issued on July 4, 2000, "Polymerizable biodegradable polymers including carbonate or dioxanone linkages"; U.S. 6,162,241, issued on December 4, 2000, "Hemostatic tissue sealants"; U.S. 6,270,464, issued on August 7, 2001, "Biopsy localization method and device"; U.S. 6,356,782, issued on March 12, 2002, "Subcutaneous cavity marking device and method"; U.S. 6,605,294, issued on August 12, 2003, "Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels ... 8,600,481, “Subcutaneous cavity marking device”; and US 8,939,910, issued January 27, 2015, “Method for enhancing ultrasonic visibility of hyperechoic materials”. All of these US patents are incorporated by reference in their entirety.

[0005] Once the marker is placed at the biopsy site, it can be repositioned later in a subsequent follow-up procedure to identify the biopsy site. In some cases, when the marker is repositioned, the placed marker may not correspond exactly to the biopsy site. For example, during the intervening time between the biopsy procedure and the subsequent follow-up procedure, the marker may migrate to another nearby location. Migration of the biopsy site marker may cause difficulty in identifying the biopsy site during a subsequent follow-up procedure. Therefore, it may be desirable to incorporate some features into the marker to maintain the marker in a fixed position over time.

[0006] While several systems and methods have been made and used to mark biopsy sites, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] While the specification concludes with claims that particularly point out and distinctly claim the invention, it is believed that the invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings in which like reference numerals designate like elements. In the drawings, some components or portions of components are shown in phantom form with dashed lines.

[0008] Figure 1 A stereogram depicting an example of a biopsy site marker;

[0009] Figure 2 Depicted Figure 1 Detailed side elevation view of the markers;

[0010] Figure 3A Depicted Figure 1 A side elevation view of a marker of the invention, the marker being in a pre-deployment configuration;

[0011] Figure 3B Depicted Figure 1 Another side elevation view of the marker, the marker being in a deployed configuration;

[0012] Figure 4 Depicted Figure 1 A front elevation view of a marker located at Figure 3B The expanded configuration of

[0013] Figure 5 A perspective view depicting another example of a biopsy site marker;

[0014] Figure 6 A perspective view depicting yet another example of a biopsy site marker;

[0015] Figure 7 Depicted Figure 6 Detailed side elevation view of the markers;

[0016] Fig. 8A Depicted Figure 6 A side elevation view of a marker of the invention, the marker being in a pre-deployment configuration;

[0017] Figure 8B Depicted Figure 6 Another side elevation view of the marker, the marker being in a deployed configuration;

[0018] Fig. 9 Depicted Figure 6 A front elevation view of a marker located at Figure 8B The expanded configuration of

[0019] Fig.10 A perspective view depicting yet another example of a biopsy site marker;

[0020] Fig.11A , Fig. 11B and Fig. 11C shows exemplary aspects of placing yet another biopsy site marker according to aspects of the present disclosure;

[0021] Fig.12 depicts a perspective view of an example of a marker delivery device;

[0022] Fig.13 Depicted Fig.12 a side cross-sectional view of a marker delivery device; and

[0023] Fig.14 Depicts a cross-sectional view of yet another marker, the marker being Fig.11A The distal portion of the marker delivery device is deployed and passed through a lateral hole in the biopsy needle to mark the biopsy site.

[0024] The accompanying drawings are not intended to be limiting in any respect, and it is contemplated that various embodiments of the invention may be implemented in a variety of other ways, including those not necessarily depicted in the accompanying drawings. The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0025] 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 through the following description, which is illustrated by way of example and is one of the best modes for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which will not depart from the present invention. Therefore, the drawings and description should be considered illustrative and non-restrictive in nature.

[0026] It may be beneficial to be able to mark the location or margins of a lesion (whether temporarily or permanently) before or immediately after it is removed or sampled. Marking prior to removal can help ensure that the entire lesion is removed, if necessary. Alternatively, if a lesion is inadvertently completely removed, marking the biopsy site immediately after the procedure will allow its location to be reconfirmed for future identification.

[0027] Once the marker is positioned at the biopsy site, it may be desirable for the marker to remain visible under ultrasound. It may also be desirable to make the marker 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. Generally, microcalcifications are used to identify suspicious lesions or masses on site. Therefore, it is generally desirable for the ultrasound view to be distinguishable as a marker without being inadvertently identified as a new mass.

[0028] III. Examples of Biopsy Site Markers for Limited Migration

[0029] In some versions of biopsy site markers, it may be desirable to include certain features within the marker to reduce the tendency of the marker to migrate when placed within the tissue. For example, some markers may be prone to migration after being placed at the biopsy site due to movement of the tissue in the intervening time between marker placement and subsequent follow-up procedures. As a result, these markers may make it difficult to accurately identify the biopsy site during subsequent follow-up procedures. Therefore, it may be desirable to incorporate features into the marker to help maintain the marker in a fixed position over time. Although several versions incorporating the above features are described herein, it should be understood that various alternative combinations may be used without departing from the basic principles described herein.

[0030] A. Example of a biopsy site marker with a central base

[0031] Figure 1 An exemplary marker (500) is shown, which is generally configured to expand from a pre-deployment configuration to a post-deployment configuration, thereby anchoring the marker (500) in the tissue. The marker (500) of this version includes a marker element (512). In some versions, the marker element (512) can be substantially similar to the marker element (12) described in more detail below. Therefore, the marker element (512) can be generally configured to be non-bioabsorbable, non-radiopaque and / or echogenic to enhance visualization over time. In addition, although not shown, it should be understood that in some versions, the marker (500) can include a structure similar to the carrier (120) described in more detail below. In versions including a structure similar to the carrier (120), this structure can be formed as described below, or alternatively configured as a coating. In other versions, the marker (500) can include only the marker element (512), omitting a structure similar to the carrier (120) described below. In other words, in some versions, marker (500) may be configured as a “naked” marker.

[0032] The marker (500) of this version is configured to transform from a pre-deployment configuration to a post-deployment configuration after deployment at a biopsy site. The marker (500) includes a base (520) and an anchor portion (540), wherein both the base (520) and the anchor portion (540) are defined by a marker element (512). The base (520) defines a generally cylindrical shape. In this version, the base (520) is hollow and defines an open proximal end (522) on each proximal and distal side of the base (520) (see FIG. 5A ). Figure 4 ). In other versions, base (520) may be partially or substantially solid.

[0033] The anchor portion (540) includes a distal anchor portion (580) and a proximal anchor portion (582) extending distally and proximally from the base portion (520), respectively. In other words, the base portion (520) is disposed between the distal anchor portion (580) and the proximal anchor portion (582). In addition, the hollow interior of the base portion (520) may be open to the interiors of the distal anchor portion (580) and the proximal anchor portion (582). As will be described in more detail below, the anchor portion (540) is generally configured to transform from a pre-deployment configuration to a post-deployment configuration in response to one or more environmental stimuli.

[0034] Although references herein to the "anchor" in anchor portion (540) may indicate that only anchor portion (540) may be used to anchor marker (500) within tissue, it should be understood that other features of marker (500) may also be used to facilitate anchoring within tissue. Such anchoring functionality may be present even if the term "anchor" or similar terms are not directly used herein to refer to a feature. For example, in some cases, one or more portions of base (520) may also have an anchoring function by facilitating tissue growth into marker (500). Additionally or alternatively, some versions of marker (500) may include a structure similar to carrier (120) that can expand within tissue and be used to further facilitate anchoring marker (500) within tissue.

[0035] The distal anchor portion (580) and the proximal anchor portion (582) of this version each include a plurality of active arms (542) (also referred to as movable arms, engagement arms, or anchor arms) and a plurality of inactive arms (592) (also referred to as passive arms, fixed arms, or straight arms) extending outwardly from the base portion (520) along the longitudinal axis defined by the marker element (512). The arms (542, 592) are oriented together in a circular pattern corresponding to the cylindrical shape of the base portion (520). Around the circular pattern, the arms (542, 592) are arranged in an alternating configuration - alternating between active arms (542) and inactive arms (592). In other words, the arms (542, 592) are arranged such that there is an inactive arm (592) positioned between each active arm (542).

[0036] Although the present version includes three movable arms (542) and three inactive arms (592), it should be understood that in other versions, other appropriate numbers of arms (542, 592) may be used, such as two, four, five, etc. In addition, or alternatively, in other versions, any appropriate number of arms (542, 592) combinations may be used, rather than three movable arms (542) and three inactive arms (592). In other versions, the distal anchor portion (580) may have any of the configurations of the arms (542, 592) described above, while the proximal anchor portion (582) may have another of the configurations of the arms (542, 592) described above. Each arm (542, 592) is defined by a plurality of slots extending from the distal end of the marker element (512) to the base (520). As will be described in more detail below, one or more arms (542, 592) are generally configured to move from a pre-deployment position to a post-deployment position. For reference, the post-deployment position is as shown in FIG. Figure 1 shown.

[0037] Each arm (542, 592) defines a substantially semi-cylindrical cross-sectional shape, such that each arm (542, 592) can abut against each adjacent arm (542, 592) to form a cylindrical shape corresponding to the shape of the base (520). Specifically, each arm (542, 592) includes a curved inner surface (544, 545) and a curved outer surface (546, 548), respectively. Therefore, when each arm (542, 592) is positioned to abut against each adjacent arm (542, 592), the curved surfaces (544, 545, 546, 548) together form a cylindrical inner surface and outer surface.

[0038] The inner end of each arm (542, 592) is fixed to the corresponding outer end of the base (520), so that each arm (542, 592) extends outward from the base (520). In this version, each arm (542, 592) is integral with the base (520), although in other versions, each arm (542, 592) can be fixedly fixed to the base (520).

[0039] A portion of the base (520) and / or each arm (542, 592) defines a plurality of release openings (560). Figure 2 As can be most clearly seen in the drawings, each release opening (560) has a generally teardrop-shaped or circular configuration. Each release opening (560) further extends completely through the surface of the base (520) and / or a portion of each arm (542, 592) into the hollow interior of the marker element (512). As will be described in more detail below, each release opening (560) is configured to facilitate flexion of each movable arm (542) relative to the base (520) and each adjacent arm (542, 592).

[0040] The outer end of each movable arm (542) includes a tip (562) having a blunt configuration. Specifically, all edges of each movable arm (542) that intersect at the tip (562) are generally rounded or otherwise fused together so that the tip (562) of each movable arm (542) is generally in a non-invasive configuration. In some versions, such a configuration may be desirable to facilitate movement of the movable arm (542) through tissue during or after deployment. For example, during deployment, the blunt configuration of each tip (562) may be suitable for facilitating easy movement through various instruments, devices and / or tissues. Similarly, after deployment, the blunt configuration of each tip (562) may facilitate movement of the arm (542) through tissue without impeding movement and without unnecessarily damaging surrounding tissue. Although in the present version each inactive arm (592) includes a cut-off or flattened distal end, it should be understood that in other versions each inactive arm (592) may include an end having a blunted configuration similar to the tip (562) described above with respect to the active arm (542).

[0041] In this version, the active arm (542) defines a shorter extension length from the base (520) than the inactive arm (592). In other words, the active arm (542) is generally shorter than the inactive arm (592). As will be described in more detail below, this feature may be suitable for facilitating the conversion of the active arm (542) from the pre-deployment configuration to the post-deployment configuration. In other versions, the length of the active arm (542) may be substantially the same as the length of the inactive arm (592). In addition, although each active arm (542) has substantially the same length relative to each other active arm (542), and each inactive arm (592) has substantially the same length relative to each other inactive arm (592), it should be understood that in some versions, the individual lengths of each active arm (542) and / or inactive arm (592) may vary. For example, in some versions, one or more active arms (542) may be longer than other active arms (542). Similarly, one or more inactive arms (592) may be longer than other inactive arms (592). Still other variations in the configuration of each arm (542, 592) relative to the other arms (542, 592) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0042] The marker element (512) of this version generally has a mirror image configuration, wherein the arms (542, 592) extend from each side of the base (520) in a substantially similar configuration. In other words, the arms (542, 592) on the proximal side of the marker element (512) form a mirror image of the arms (542, 592) on the distal side of the marker element (512), wherein the base (520) is positioned at the center of the marker element (512). However, it should be understood that in other versions, various asymmetric or non-mirror image configurations may be used. For example, in some versions, the arms (542, 592) may extend only from a single side of the base (520). In other versions, the arms (542, 592) on one side of the marker element (512) may be longer relative to the arms (542, 592) on the other side of the marker element (512). Therefore, in some versions, the base (520) may be positioned off-center relative to the arms (542, 592).

[0043] As described above, the active arm (542) can move between the pre-deployment configuration and the post-deployment configuration. Meanwhile, the inactive arm (592) can remain substantially stationary during the transition of the active arm (542) from the pre-deployment configuration to the post-deployment configuration. Figure 1 and Figure 2 The movable arms (542) are shown in a deployed state. In this state, each movable arm (542) is bent outward from the longitudinal axis defined by the marker element (512). In other words, the movable arms (542) can be opened outward relative to each other. In addition, in this state, the inactive arms (592) maintain a generally straight configuration, extending along the longitudinal axis defined by the marker element (512). In some versions, the outward extension, bending and / or opening of the movable arms (542) can cause the diameter of the marker (500) to be approximately twice the diameter when in the pre-deployment configuration. In other versions, this outward extension, bending and / or opening of the movable arms (542) can cause the diameter of the marker (500) to be approximately three times the diameter when in the pre-deployment configuration.

[0044] from Figure 2 As can be clearly seen in the figure, the specific outward curvature of each movable arm (542) can be non-linear, wherein the curvature initially has a relatively low slope and subsequently has a relatively high slope. In other words, the curvature of each movable arm (542) can be approximated as an exponential. In other versions, each movable arm (542) can be configured with a curvature having one or more inflection points such that the movable arm (542) can have a more irregular shape relative to the continuously increasing slope shown. In addition, or alternatively, in some versions, the specific curvature used can vary between the movable arms (542), wherein one or more movable arms (542) have an irregular curvature and one or more other movable arms (542) have a curvature that is substantially the same as that of the movable arms (542). Figure 2A relatively continuous curvature similar to the curvature shown in .

[0045] As described above, the arms (542, 592) of this version are integral with the base (520). The marker element (512) is therefore a single unitary, homogeneous, continuous material. The particular material used in this version is a shape memory alloy. As will be described in more detail below, the shape memory properties of the material used in the marker element (512) can be used to allow the movable arm (542) to be converted from a pre-deployment configuration to a post-deployment configuration, wherein the conversion is initiated using the patient's heat from the tissue surrounding the biopsy site.

[0046] It should be appreciated that a variety of suitable shape memory alloys may be used for the marker element (512). In addition, the composition of any shape memory alloy may be varied to produce desired properties (e.g., transition temperature). A suitable shape memory alloy may include Nitinol (nickel titanium). Any suitable grade of Nitinol may be used. By way of example only, a suitable grade of Nitinol may include Nitinol S (ASTM 2063). Alternatively, other shape memory alloys may include copper-based alloys, gold-cadmium alloys, silver-cadmium alloys, and / or nickel-aluminum alloys.

[0047] Back to Figure 1 , the entire outer surface of the marker element (512) may include a surface treatment (surface treatment, ST). The surface treatment (ST) is generally configured to enhance the echogenicity of the marker element (512). In this version, the surface treatment (ST) includes a rough surface texture caused by sandblasting. However, it should be understood that in other versions, various alternative surface treatments (ST) can be used. For example, in some versions, the surface treatment (ST) may include an echogenic coating having a plurality of microspheres and a polymer adhesive. Such a coating can be used as a supplement to sandblasting, or instead of sandblasting. In addition, or alternatively, other versions may include a rough surface formed by various processing mechanisms (e.g., shot peening, grinding, knurling, etc.). Of course, various alternative surface treatment (ST) configurations can be used, which will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0048] FIG. 3A to FIG. 4 Various aspects of using a marker element (512) to mark tissue are shown. Figure 3AAs can be seen, the marker element (512) can initially begin with the active arms (542) in a pre-deployment configuration. In the pre-deployment configuration, the active arms (542) can be compressed inwardly toward the longitudinal axis defined by the marker element (512) so that each active arm (542) is adjacent to each adjacent inactive arm (592). When the active arms (542) are compressed as shown, the arms (542, 592) together form a generally hollow cylindrical shape corresponding to the shape of the base (520). Thus, when the active arms (542) are in the pre-deployment configuration, the marker element (512) can define a generally cylindrical shape.

[0049] In some versions, the deployed configuration described above may correspond to a "natural," "original," "formed," or "undeformed" shape. In other words, the deployed configuration may be the natural or manufactured shape imparted to the active arm (542) of the shape memory alloy. The active arm (542) may then be subsequently compressed into the shape memory alloy during manufacturing. Figure 3A The pre-deployment shape is shown to prepare marker element (512) for deployment at a biopsy site.

[0050] Regardless of how the movable arm (542) is converted to the pre-deployment configuration, the marker element (512) can be introduced into the biopsy site of the patient while in the pre-deployment configuration. In some uses, the introduction of the marker element (512) can be performed using a marker delivery device (150) described in more detail below. The pre-deployment configuration may be suitable for introduction at the biopsy site because the compact and uniform shape can facilitate use with instruments similar to the marker delivery device (150) described below. The compact and uniform shape can also facilitate movement of the marker element (512) through tissue for placement at the biopsy site.

[0051] Once the marker element (512) is positioned as desired, the marker element (512) can absorb heat from tissue near the biopsy site and increase its temperature. The temperature of the marker element (512) can increase until the transformation temperature of the shape memory alloy of the marker element (512) is reached. Once the transformation temperature is reached, the alloy may return to its natural, original or undeformed shape. In this version, this shape corresponds to the post-deployment configuration of the movable arm (542). Therefore, heat from the patient can initiate the transition of the movable arm (542) from the pre-deployment configuration to the post-deployment configuration.

[0052] from Figure 3B and Figure 4As can be seen most clearly in FIG. 5 , the transition to the deployed configuration includes the movable arms (542) moving away from the longitudinal axis defined by the marker element (512). In other words, the movable arms (542) may expand or splay outward relative to each other. During this transition, the movable arms (542) may engage tissue surrounding the biopsy site to anchor the marker element (512) in the tissue, thereby maintaining the marker element (512) in place at the biopsy site.

[0053] During the entire transition of the active arm (542) from the pre-deployment configuration to the post-deployment configuration, the inactive arm (592) remains substantially stationary. Figure 3A and Figure 3B As can be most clearly seen in the figure, the inactive arm (592) generally maintains a straight configuration throughout the transition of the active arm (542) from the pre-deployment configuration to the post-deployment configuration. In this straight configuration of the inactive arm (592), the inactive arm (592) remains in a position extending along the longitudinal axis defined by the marker element (512). In some versions, the configuration of the inactive arm (592) in the straight and static configuration shown may be suitable for facilitating the anchoring of the marker (500). For example, the inactive arm (592) can set and maintain the initial position of the marker (500) by engaging tissue adjacent to the proximal and distal ends of the marker. This initial position of the marker (500) can then be maintained by the inactive arm (592) until the active arm (542) fully engages the adjacent tissue by transitioning from the pre-deployment configuration to the post-deployment configuration.

[0054] Figure 5 Another version of a biopsy site marker (600) is shown that is substantially similar to the marker (500) described above. For example, similar to the marker (500) described above, the present version of the marker (600) includes a marker element (612) that can be used as a "bare" marker or in conjunction with a structure similar to the carrier (120) described below. As with the marker element (512) described above, the present version of the marker element (612) includes a base (620) from which an anchor portion (640) extends outwardly along a longitudinal axis defined by the marker element (612). Similar to the description above regarding the anchor portion (540), the present version of the anchor portion (640) includes a distal anchor portion (680) and a proximal anchor portion (682).

[0055] Each of the distal anchor portion (680) and the proximal anchor portion (682) includes a set of active arms (642) and a set of inactive arms (692) extending outwardly from the base portion (620). Unless otherwise noted below, the configuration and function of the arms (642, 692) are similar to those described above with respect to the arms (542, 592). For example, as with the arms (542, 592) described above, the arms (642, 692) of this version may be configured such that the active arms (642) may be transformed from a pre-deployment configuration to a post-deployment configuration, while the inactive arms (692) remain in a generally stationary or static configuration.

[0056] Unlike the movable arms (542) described above, each movable arm (642) of this example includes one or more openings (670) extending through the surface of each movable arm (642) and communicating with the hollow interior of the marker element (612). In this version, each movable arm (642) includes one opening (670), although multiple openings (670) may be used in other versions. The opening (670) in each movable arm (642) is located near the base (620) and may overlap at least a portion of the base (620) in some versions. In some versions, the opening (670) may be configured to promote tissue growth into the marker element (612). In addition, or alternatively, in some versions, the opening (670) may be configured to provide enhanced visualization by providing enhanced echogenic properties for visualization under ultrasound or providing a more visible shape under x-ray.

[0057] Unlike the above-described movable arm (542), the movable arm (642) of this example defines a different shape in the deployed configuration. Specifically, Figure 5 The deployed configuration of the movable arm (642) is shown. It can be seen that when in the deployed configuration, the movable arm (642) defines a generally straight but angled configuration. In other words, the movable arm (642) can form a linear shape, rather than being curved, that has a constant slope away from the longitudinal axis defined by the marker element (612). Although a generally linear shape having only one slope is shown in this version, it should be understood that in other versions, multiple single slopes can be used, wherein one portion of each movable arm (642) extends at a first angle, and one or more other portions of each movable arm (642) extend at a second angle different from the first angle.

[0058] B. Example of a biopsy site marker with a central anchor

[0059] Figure 6Another exemplary biopsy site marker (700) is shown, which is generally configured to expand from a pre-deployment configuration to a post-deployment configuration, thereby anchoring the marker (700) in the tissue. In some versions, the marker (700) is similar to the markers (500, 600) described above or the marker (100) described below. For example, as with markers (500, 600), the marker (700) of this version includes a marker element (712). In some versions, the marker element (712) can be generally configured to be non-bioabsorbable, non-radiopaque and / or echogenic to enhance visualization over time. In addition, although not shown, it should be understood that in some versions, the marker (700) can include a structure similar to the carrier (120) described below. In versions including a structure similar to the carrier (120), such a structure can be formed as described above, or alternatively configured as a coating. In other versions, marker (700) may include only marker element (712), omitting structures similar to carrier (120) described below. In other words, in some versions, marker (700) may be configured as a "naked" marker.

[0060] The marker (700) of this version is configured to convert from a pre-deployment configuration to a post-deployment configuration after deployment at a biopsy site. The marker (700) includes a distal base (720), a proximal base (722), and an anchor (740) extending between the bases (720). In this example, the bases (720, 722) and the anchor (740) are defined by a marker element (712). Each base (720, 722) defines a generally cylindrical shape. In this version, each base (720, 722) is hollow, and a corresponding open end (724, 726) is defined on the outside of each base (720, 722). In other versions, each base (720, 722) may be partially or substantially solid.

[0061] The anchor portion (740) extends between each base portion (720, 722) from a distal portion of the marker element (712) to a proximal portion of the marker element (712). In other words, each base portion (720, 722) is disposed on a respective end of the anchor portion (740). Additionally, the hollow interior of each base portion (720, 722) may be open to the interior of the anchor portion (740). As will be described in greater detail below, the anchor portion (740) is generally configured to transition from a pre-deployment configuration to a post-deployment configuration in response to one or more environmental stimuli.

[0062] The anchor portion (740) of this version includes a plurality of active arms (742) (also referred to as movable arms, engagement arms, or anchoring arms) and a plurality of inactive arms (792) (also referred to as passive arms, stationary arms, static arms, or straight arms) extending inwardly from each base (720, 722) along a longitudinal axis defined by the marker element (712). The arms (742, 792) are oriented together in a circular pattern corresponding to the cylindrical shape of each base (720, 722). Around the circular pattern, the arms (742, 792) are arranged in an alternating configuration - alternating between active arms (742) and inactive arms (792). In other words, the arms (742, 792) are arranged such that there is an inactive arm (792) positioned between each active arm (742).

[0063] This version includes three active arms (742) and six inactive arms (782). Specifically, each active arm (742) extends completely from the distal base (720) to the proximal base (722), thereby defining a continuous material portion connecting the distal base (720) to the proximal base (722). At the same time, each inactive arm (782) extends inward only from the distal base (720) or the proximal base (722). In other words, each inactive arm (782) includes a disconnected material portion between the distal base (720) and the proximal base (722). In some versions, this disconnected configuration of the inactive arm (782) may be suitable for providing at least some freedom of movement relative to the active arm (742), as described in more detail below.

[0064] Although the present version includes three movable arms (742) and six inactive arms (792), it should be understood that in other versions, other suitable numbers of arms (742, 792) may be used, such as two, four, five, etc. Additionally, or alternatively, in other versions, any suitable number of arms (742, 792) combinations may be used, rather than three movable arms (742) and three inactive arms (792).

[0065] Each arm (742, 792) is defined by a plurality of slots extending from the distal base (720) to the proximal base (722). As will be described in more detail below, one or more arms (742, 792) are generally configured to move from a pre-deployment position to a post-deployment position. For reference, the post-deployment position is as follows: Figure 6 shown.

[0066] Each arm (742, 792) defines a substantially semi-cylindrical cross-sectional shape, such that each arm (742, 792) can abut against each adjacent arm (742, 792) to form a cylindrical shape corresponding to the shape of the base (720, 722). Specifically, each arm (742, 792) includes a curved inner surface (744, 745) and a curved outer surface (746, 748), respectively. Therefore, when each arm (742, 792) is positioned to abut against each adjacent arm (742, 792), the curved surfaces (744, 745, 746, 748) together form a cylindrical inner surface and outer surface.

[0067] A portion of the base (720, 722) and / or each arm (742, 792) defines a plurality of release openings (760). Figure 7 As can be most clearly seen in the drawings, each release opening (760) has a generally teardrop-shaped or circular configuration. Each release opening (760) also extends completely through the surface of the base (720, 722) and / or a portion of each arm (742, 792) into the hollow interior of the marker element (712). As will be described in more detail below, each release opening (760) is configured to facilitate flexion of each movable arm (742) relative to the base (720) and each adjacent arm (742, 792).

[0068] In this version, the active arm (742) defines a longer extension length between each base (720, 722) relative to each inactive arm (792). In other words, the inactive arm (792) is generally shorter than the active arm (742). As will be described in more detail below, this feature may be suitable for facilitating the conversion of the active arm (742) from the pre-deployment configuration to the post-deployment configuration. In other versions, the length of the active arm (742) may be substantially the same as the length of the inactive arm (792). In addition, although each active arm (742) has substantially the same length relative to each other active arm (742), and each inactive arm (792) has substantially the same length relative to each other inactive arm (792), it should be understood that in some versions, the individual lengths of each active arm (742) and / or inactive arm (792) may vary. For example, in some versions, one or more active arms (742) may be longer than other active arms (742). Similarly, one or more inactive arms (792) may be longer than other inactive arms (792). Still other variations in the configuration of each arm (742, 792) relative to the other arms (742, 792) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0069] The marker element (712) of this version generally has a mirror image configuration, wherein the arms (742, 792) extend inwardly from each base (720, 722) with a substantially similar configuration. In other words, each active arm (742) extends from one side of the marker element (712) to the other side, and the inactive arm (792) extends from each base (720, 722) with the same but mirror image configuration. However, it should be understood that in other versions, various asymmetric or non-mirror image configurations can be used. For example, in some versions, the arms (742, 792) can extend only from a single base (720, 722). In other versions, the inactive arm (792) on one side of the marker element (712) may be longer relative to the inactive arm (792) on the other side of the marker element (712). In such versions, the length of the inactive arm (792) can vary so that the inactive arm (792) can form an interlocking relationship together.

[0070] As described above, the active arm (742) can move between the pre-deployment configuration and the post-deployment configuration. Meanwhile, the inactive arm (792) can remain substantially stationary during the transition of the active arm (742) from the pre-deployment configuration to the post-deployment configuration. Figure 6 and Figure 7 The movable arms (742) are shown in a deployed state. In this state, each movable arm (742) is bent outward from the longitudinal axis defined by the marker element (712). In other words, the movable arms (742) can be opened outward relative to each other. In addition, in this state, the inactive arms (792) maintain a generally straight configuration, extending along the longitudinal axis defined by the marker element (712). In some versions, the outward extension, bending and / or opening of the movable arms (742) can cause the diameter of the marker (700) to be approximately twice the diameter when in the pre-deployment configuration. In other versions, this outward extension, bending and / or opening of the movable arms (742) can cause the diameter of the marker (700) to be approximately three times the diameter when in the pre-deployment configuration.

[0071] from Figure 6 and Figure 7As can be most clearly seen, the specific outward curvature of each movable arm (742) can be non-linear, with the curvature initially having a relatively low slope, followed by a relatively high slope, then reversing to a relatively low slope, followed by a relatively high slope, and finally a relatively low slope. In other words, the curvature of each movable arm (742) can be approximately parabolic or arcuate. It can be seen that this shape configuration of each movable arm (742) has an inflection point approximately located at the center of the marker element (712). In some versions, the specific curvature used can vary between movable arms (742), with one or more movable arms (542) having an irregular curvature, a greater curvature, etc., and one or more other movable arms (742) having a curvature that is similar to that of the movable arm (742). Figure 6 A relatively continuous curvature similar to the curvature shown in .

[0072] As described above, the arms (742, 792) of this version are integral with the base (720). The marker element (712) is therefore a single material. The particular material used in this version is a shape memory alloy. As will be described in more detail below, the shape memory properties of the material used in the marker element (712) can be used to allow the movable arm (742) to be converted from a pre-deployment configuration to a post-deployment configuration, wherein the conversion is initiated using the patient's heat from the tissue surrounding the biopsy site.

[0073] It should be appreciated that a variety of suitable shape memory alloys may be used for the marker element (712). In addition, the composition of any shape memory alloy may be varied to produce desired properties (e.g., transition temperature). A suitable shape memory alloy may include Nitinol (nickel titanium). Any suitable grade of Nitinol may be used. By way of example only, a suitable grade of Nitinol may include Nitinol S (ASTM 2063). Alternatively, other shape memory alloys may include copper-based alloys, gold-cadmium alloys, silver-cadmium alloys, and / or nickel-aluminum alloys.

[0074] Back to Figure 6 , the entire outer surface of the marker element (712) may include a surface treatment (ST). The surface treatment (ST) is typically configured to enhance the echogenicity of the marker element (712). In this version, the surface treatment (ST) includes sandblasting. However, it should be understood that in other versions, various alternative surface treatments (ST) may be used. For example, in some versions, the surface treatment (ST) may include an echogenic coating having a plurality of microspheres and a polymer adhesive. Such a coating may be a supplement to sandblasting, or may replace sandblasting. In addition, or alternatively, other versions may include a rough surface formed by various processing mechanisms (e.g., shot peening, grinding, knurling, etc.). Of course, various alternative surface treatment (ST) configurations may be used, which will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0075] FIG. 8A to FIG. 9 An aspect of marking tissue using a marker element (712) is shown. Fig. 8A As can be seen, marker element (712) can initially begin with active arms (742) in a pre-deployment configuration. In the pre-deployment configuration, active arms (742) can be compressed inwardly toward the longitudinal axis defined by marker element (712) such that each active arm (742) abuts each adjacent inactive arm (792). When active arms (742) are compressed as shown, arms (742, 792) together form a generally hollow cylindrical shape corresponding to the shape of bases (720, 722). Thus, when active arms (742) are in the pre-deployment configuration, marker element (712) can define a generally cylindrical shape. In some versions, as active arms (742) are compressed inwardly into Fig. 8A Shown in a straight shape, the length of marker element (712) may also increase when in the pre-deployment configuration.

[0076] In some versions, the deployed configuration described above may correspond to a "natural," "original," "formed," or "undeformed" shape. In other words, the deployed configuration may be the natural or manufactured shape imparted to the active arm (742) of the shape memory alloy. The active arm (742) may then be subsequently compressed into the shape memory alloy during manufacturing. Fig. 8A The pre-deployment shape is shown to prepare marker element (712) for deployment at a biopsy site.

[0077] Regardless of how the movable arm (742) is transformed to the pre-deployment configuration, the marker element (712) can be introduced into the biopsy site of the patient while in the pre-deployment configuration. In some uses, the introduction of the marker element (712) can be performed by a marker delivery device (150) described in more detail below. The pre-deployment configuration may be suitable for introduction at the biopsy site because the compact and uniform shape can facilitate use with instruments similar to the marker delivery device (150) described below. The compact and uniform shape can also facilitate movement of the marker element (712) through tissue for placement at the biopsy site.

[0078] Once the marker element (712) is positioned as desired, the marker element (712) can absorb heat from tissue near the biopsy site and increase its temperature. The temperature of the marker element (712) can increase until the transformation temperature of the shape memory alloy of the marker element (712) is reached. Once the transformation temperature is reached, the alloy may return to its natural, original or undeformed shape. In this version, this shape corresponds to the post-deployment configuration of the movable arm (742). Therefore, heat from the patient can initiate the transition of the movable arm (742) from the pre-deployment configuration to the post-deployment configuration.

[0079] from Figure 8B and Fig. 9 As can be most clearly seen, the transition to the deployed configuration includes the movable arms (742) moving outwardly away from the longitudinal axis defined by the marker element (712). In other words, the movable arms (742) can expand or splay outwardly relative to each other. At the same time, the overall length of the marker element (712) can decrease in proportion to the outward expansion of the movable arms (742). During this transition, the movable arms (742) can engage tissue surrounding the biopsy site to anchor the marker element (712) in the tissue, thereby maintaining the marker element (712) in place at the biopsy site.

[0080] During the entire transition of the active arm (742) from the pre-deployment configuration to the post-deployment configuration, the inactive arm (792) remains substantially stationary. Fig. 8A and Figure 8B As can be most clearly seen in the Figure 1 , the inactive arm (792) remains in a generally straight configuration throughout the transition of the active arm (742) from the pre-deployment configuration to the post-deployment configuration. In this straight configuration of the inactive arm (792), the inactive arm (792) remains in a position extending along the longitudinal axis defined by the marker element (712). In some versions, the configuration of the inactive arm (792) in the straight and static configuration shown may be suitable for facilitating anchoring of the marker (700). For example, the inactive arm (792) may provide an irregular internal profile of the marker element (712), which may be used to facilitate tissue growth between the inactive arms (792).

[0081] Fig.10 Another version of a biopsy site marker (800) is shown that is substantially similar to the marker (700) described above. For example, similar to the marker (700) described above, this version of the marker (800) includes a marker element (812) that can be used as a "bare" marker or in conjunction with a structure similar to the carrier (120) described below. As with the marker element (712) described above, this version of the marker element (812) includes a distal base (820), a proximal base (822), and an anchor (840) that extends between the distal base (820) and the proximal base (822) along a longitudinal axis defined by the marker element (812).

[0082] As with the anchor portion (740) described above, the present version of the anchor portion (840) includes a set of active arms (842) and a set of inactive arms (892) extending inwardly from each base portion (820, 822). Unless otherwise noted below, the configuration and function of the arms (842, 892) are similar to those described above with respect to the arms (742, 792). For example, as with the arms (742, 792) described above, the present version of the arms (842, 892) can be configured such that the active arms (842) can be transformed from a pre-deployment configuration to a post-deployment configuration, while the inactive arms (792) remain in a generally stationary or static configuration.

[0083] Unlike the above-described bases (720, 722), the bases (820, 822) of this version each include one or more static anchors (824, 826). Specifically, the distal base (820) includes a plurality of distal static anchors (824, 826) extending outwardly from the outside of the distal base (820). Similarly, the proximal base (822) includes a plurality of proximal static anchors (826) extending outwardly from the outside of the proximal base (822). The static anchors (824, 826) are positioned in a generally circular pattern around the cylindrical shape of each corresponding base (820, 822).

[0084] Each static anchor (824, 826) defines a shape that generally corresponds to the shape of a small portion of each corresponding base (820, 822). In other words, each static anchor (824, 826) defines a curvature that corresponds to the curvature of each corresponding base (820, 822). In addition, each static anchor (824, 826) defines a taper, wherein the width of each static anchor (824, 826) decreases as each static anchor (824, 826) extends from each corresponding base (820, 822). The extension of each static anchor (824, 826) is slightly angled relative to the longitudinal axis of the marker element (812), such that each static anchor (824, 826) is slightly angled inwardly toward the center of the marker element (812).

[0085] The specific shape and configuration of the static anchors (824, 826) are generally configured to provide additional anchoring of the marker element (812) within the tissue. For example, the static anchors (824, 826) may provide a generally irregular shape that may capture or grab adjacent tissue, thereby holding the marker element (812) in place. Additionally, or alternatively, the irregular shape of the static anchors (824, 826) may facilitate anchoring by taking advantage of the growth of tissue between each static anchor (824, 826) and within the marker element (812).

[0086] II. Exemplary Use of Labels

[0087] Aspects presented herein relate to devices and procedures for percutaneously marking a biopsy cavity (10) with surrounding tissue (30) using a marker, such as FIG. 11A to FIG. 11C For example, from Fig.11A As can be seen in the figure, the marker (100) can first be placed in the biopsy cavity (10) to facilitate repositioning the biopsy site. Although the usage described herein is in the context of the marker (100), it should be understood that in some usages, the above-mentioned markers (500, 600, 700, 800) can be used instead of the marker (100) or as a supplement to the marker (100). The marker (100) may include a carrier (120) and a marker element (12). The carrier (120) typically includes a bioabsorbable marker material (122). Therefore, the carrier (120) is typically configured to be absorbed into the patient's body after the marker (100) is placed in the biopsy cavity (10). In some versions, the carrier (120) may include a plurality of microbubbles to enhance the visualization of the carrier (120) under ultrasound. As will be described in more detail below, the marker material (122) is generally bioabsorbable, such that the marker material (122) is generally resorbable into the patient's tissue over time. In this version, the marker material (122) comprises a hydrogel that is initially in a dehydrated state. Although a hydrogel is used in this version, it should be understood that in other versions, the marker material (122) may include other known bioabsorbable materials. As described above, in some versions, the carrier (120) may also be used with alternative marker elements (e.g., marker elements (512, 612, 712, 812)).

[0088] In this version, the marker (100) also includes a marker element (12) that is generally not bioabsorbable (e.g., permanent or semi-permanent). The marker element (12) may include a radiopaque marker or echogenic marker embedded in a bioabsorbable marker material (122) of a carrier (120). For example, the marker element (12) may include metal, hard plastic, or other radiopaque or highly echogenic materials known to those of ordinary skill in the art in view of the teachings of this article. In other versions, the marker (100) may be formed without the marker element (12). In yet other versions, the marker (100) may be formed with only the marker element (12), so that the carrier (120) is omitted and the marker element (12) is in a "naked" form. In other words, in some versions, the marker (100) is formed only by the marker element (12) as a bare clip or other structure, and the carrier (120) may be completely omitted. As noted above, in some versions, marker element (12) may be readily replaced with any one or more of marker elements (512, 612, 712, 812) described above.

[0089] Once positioned at the biopsy site within the patient, the marker material (122) is typically capable of expanding. Fig. 11B and Fig. 11C As shown, the initially dehydrated marker material (122) can absorb liquid from the surrounding tissue (30) into which it is inserted. In response to the absorption of such liquid, the marker material (122) can expand, thereby allowing the carrier (120) to fill the cavity formed at the biopsy site due to the removal of the tissue sample during the biopsy procedure. Biodegradable materials may be particularly suitable for applications where it is desired to allow natural tissue to grow over time to completely or partially replace the implanted material. Thus, biocompatibility is ensured and the natural mechanical parameters of the tissue are substantially restored to those of the original condition.

[0090] The markers (100, 500, 600, 700, 800) can be inserted into the body surgically through an opening in the body cavity (30), or can be inserted into the body through minimally invasive surgery using a device such as a catheter, an inserter, or a similar type of insertion device. The markers (100, 500, 600, 700, 800) can be delivered immediately after the tissue sample is removed using the same device used to remove the tissue sample itself. The physician can then use subsequent non-invasive detection techniques (such as x-ray mammography or ultrasound) to identify, locate, and monitor the biopsy cavity site over a period of time via the markers (100, 500, 600, 700, 800).

[0091] The present version of the marker (100) is large enough to be easily visible to a clinician, for example, under x-ray or ultrasound observation, and small enough to be deployed percutaneously into a biopsy cavity without causing any difficulty to the patient. Although the various versions of the marker (100) are described in conjunction with the treatment and diagnosis of breast tissue, the various aspects presented herein may be used with markers in any internal tissue (e.g., breast tissue, lung tissue, prostate tissue, lymph gland tissue, etc.).

[0092] Hydration of the marker material (122) of the carrier (120) by the natural moisture of the tissue surrounding it causes the polymer to expand and thereby minimize the risk of migration. The growing hydrogel-based marker material (122) places the marker (100) in the center of the biopsy cavity as it grows. As the hydrogel expands under the moisture naturally present in the surrounding tissue, hydration enables increased insonification, appearing increasingly hypoechoic and easily visualized in subsequent ultrasound studies.

[0093] The hydrated hydrogel marker material (122) of the carrier (120) may also be used to frame the permanent marker (12). The hypoechoic nature of the hydrated marker material (122) enables ultrasound visibility of the permanent marker (12) within the hydrogel hydrated marker material (122) because the permanent marker (12) is formed as a specular reflector within the hypoechoic hydrated marker with the aqueous non-reflective substrate.

[0094] III. Exemplary Marker Delivery Devices

[0095] In some versions, it may be desirable to deploy any one or more of the markers (100, 500, 600, 700, 800) described above within body cavity (30) using certain marker delivery devices. For example, Fig.12 and Fig.13 An exemplary marker delivery device (150) is shown including an elongated outer cannula (162) having a marker outlet, such as a side opening (164) formed adjacent to the distal end of cannula (162) but spaced proximally therefrom.

[0096] A handle (166) may be provided at the proximal end of the cannula (162). A push rod (168) may be provided that extends 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.13 The rod (168) may be sufficiently rigid when compressed to push the marker out of the interior lumen (165) of the cannula (162) through the opening (164), but relatively flexible when bent. A plunger (170) is coupled to the proximal end of the rod (168) to push the rod (168) distally within the cannula (162), thereby deploying the marker outside of the cannula (162).

[0097] The user may grasp grip (166) with two fingers and may use the thumb on the same hand to push plunger (170) such that marker delivery device (150) is operated by a single hand of the user. A spring (not shown) or other feature may be disposed about rod (168) to bias rod (168) proximally relative to grip (166) and cannula (162).

[0098] Fig.13A cross-sectional view of a distal portion of a marker delivery device (150) is shown. As can be seen, a biopsy site marker (300) similar to the markers (100, 500, 600, 700, 800) described above is disposed within the interior lumen (165) of the cannula (162). Although the marker delivery device (150) is shown and described herein as being used with the marker (300), it should be understood that in other uses, the marker delivery device (150) can be readily used with any one or more of the markers (100, 500, 600, 700, 800) in addition to or in lieu of the marker (300). In this version, the marker (300) includes a biodegradable or otherwise absorbable marker material (306), a generally cylindrically shaped body such as collagen, hydrogel, etc., and a metallic generally radiopaque permanent marker or marker element (310) (shown in phantom) disposed within or otherwise carried by the marker material (306).

[0099] The cannula (162) can be formed of any suitable metallic or non-metallic material. In some versions, the cannula (162) is formed of a thin-walled hollow tube formed of a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as polyether block amide (PEBA), such as known by the trade name PEBAX. The cannula (162) can be formed of PEBAX and can be substantially transparent to visible light and X-rays.

[0100] 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 the 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 the proximal opening end (164A) to the distal opening end (164B), such as Fig.13 shown.

[0101] In this version, distal tip (172) extends from the distal end of cannula (162) and is rounded, as shown. Fig.13 See Fig.13, the distal end of the cannula (162) is closed by an integral end piece (171), wherein a portion of the end piece (171) extends into the inner lumen (165) of the cannula (162). The end piece (171) may be a molded component or a cast component. The end piece (171) includes a tip (172), a ramp (210) having a ramp surface (212), and a marker engagement element (240). The ramp surface (212) helps guide the marker (300) from the inner lumen (165) through the side opening (164). The marker engagement element (240) helps keep the marker (300) in the inner lumen (165) until the user intends to deploy the marker (300).

[0102] The marker engagement element (240) is disposed within the interior lumen (165), and at least a portion of the marker engagement element (240) is disposed distally of the proximal end (164A) of the side opening (164). The marker engagement element (240) extends along a portion of the bottom of the cannula (162) below the opening (164), such that the marker engagement element (240) is positioned to reinforce the portion of the cannula (162) in which the opening (164) is formed. For example, by Fig.13 As shown, marker engagement element (240) is positioned below opening (164), element (240) helps to reinforce cannula (162) in the area where the wall of cannula (162) is cut to form opening (164). Fig.13 As shown, marker engagement element (240) extends from the proximal-most portion of ramp surface (212) and does not extend proximal to side opening (164), although in other embodiments, a portion of element (240) may extend proximal to opening (164).

[0103] like Fig.13 As shown, the marker engagement element (240) is in the form of a step having a substantially uniform thickness (T) along the axial length of the element (240), except that the element (240) has a tapered proximal end (242). The tapered proximal end (242) forms an angle of approximately 45 degrees with the longitudinal axis of the lumen (165) (at Fig.13 The angle between the center and the horizontal line is about 30 degrees, and the slope surface (212) forms an angle of about 30 degrees with the longitudinal axis. Of course, any number of other suitable angles can be used.

[0104] like Fig.13As shown, the upwardly facing surface (244) of the marker engagement element (240) (the surface facing the opening (164)) extends distally to contact the ramp surface (212) such that there is no space or gap between the surface (244) and the ramp surface (212). This arrangement is advantageous in reducing the possibility that the marker (300) may become stuck between the marker engagement element (240) and the ramp (212) when moving through the marker engagement element (240). In some versions, the marker engagement element (240), the ramp (210) and / or the tip (172) are formed of or include a material that is relatively more radiopaque than the wall of the cannula (162). For example, when the element (240), the ramp (210) and the tip (172) are formed as an integral end piece (171), the end piece (171) may include a radiopaque additive, such as barium sulfate. For example, the end piece (171) can be a component molded from PEBAX, wherein about 20 weight percent barium sulfate is added to the molten PEBAX molding composition. Relatively more radiopaque marker engagement element (240), ramp (210), and tip (22) may be useful for distinguishing the positions of these components using radiographic imaging. Additionally, when the ramp (210) and / or step of the engagement element (240) are positioned in association with the opening (164), the addition of radiopaque material can help identify the position of the opening (164) before, during, or after the marker (300) is deployed, as well as the position of the marker (300) relative to the opening (164).

[0105] refer to Fig.14 , the marker delivery device (150) is used to deploy the marker (300) (or alternatively, the marker (100, 500, 600, 700, 800)) to mark a biopsy location in a patient's body. Fig.14 , a tubular biopsy needle (400) is shown having a closed distal end with a piercing tip (402) and a lateral tissue receiving hole (414). The marker delivery device (150) 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 the various patents and patent applications that have been mentioned and incorporated herein by reference, but other biopsy devices may also be used.

[0106] Fig.14The distal end of a marker delivery device (150) is shown disposed within a needle (400). The needle (400) can be positioned in tissue, and a biopsy sample can be obtained through a lateral aperture (414), thereby providing a biopsy cavity adjacent to the lateral aperture (414). Then, after the tissue sample has been obtained and proximally transferred through the needle (400), and without removing the needle (400) from the patient's tissue, the marker delivery device (150) is inserted into the proximal opening in the needle (400). Fig.14 In the embodiment of the present invention, the needle (400) and the marker delivery device (150) are positioned such that the opening (164) of the cannula (162) and the lateral hole (414) of the needle (400) are substantially aligned axially and circumferentially. Then, with the marker delivery device (150) and the needle (400) so positioned at the biopsy site, the push rod (168) is advanced to deploy the marker (300) upward along the ramp surface (212), through the opening (164), and then through the lateral hole (414) into the biopsy cavity.

[0107] IV. Exemplary Combinations

[0108] The following examples relate to various non-exhaustive ways in which the teachings of this document may be combined or applied thereto. It should be understood that the following embodiments are not intended to limit the coverage of any claims that may be raised at any time in this application or in subsequent documents of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is conceivable that the various teachings of this document may be arranged and applied in many other ways. It is also conceivable that some variations may omit certain feature parts mentioned in the following examples. Therefore, unless the inventor or the inventor's successor in interest later explicitly points out, any aspect or feature mentioned below should not be considered critical. If any claim raised in this application or in subsequent documents related to this application includes additional features in addition to the features described below, it shall not be presumed that these additional features are added for any reason related to patentability.

[0109] Example 1

[0110] A biopsy site marker comprises: a marker element, the marker element comprising a base and an anchor portion, the anchor portion extending from the base, the anchor portion comprising a plurality of arms, one or more of the plurality of arms being configured to transform from a pre-deployment configuration to a post-deployment configuration in response to heat, each transformed arm of the plurality of arms extending outwardly from a longitudinal axis defined by the marker element when in the post-deployment configuration.

[0111] Example 2

[0112] The marker of Example 1, wherein each arm of the plurality of arms is configured to abut one or more adjacent arms when in the pre-deployment configuration.

[0113] Example 3

[0114] The marker of Example 1 or 2, wherein each of the plurality of arms is arranged in a circular pattern relative to the base.

[0115] Example 4

[0116] The marker of any one or more of Examples 1 to 3, wherein each arm has a curved inner surface and a curved outer surface, and the curved inner surface and the curved outer surface of each arm of the multiple arms are configured to form a hollow cylindrical shape when the multiple arms are in the pre-deployment configuration.

[0117] Example 5

[0118] The marker of any one or more of Examples 1 to 4, wherein the base includes a first base and a second base, and one or more of the plurality of arms extend from the first base to the second base.

[0119] Example 6

[0120] The marker of any one or more of Examples 1 to 5, wherein each transformed arm of the plurality of arms defines a curved exponential or parabolic shaped profile when in the post-deployment configuration.

[0121] Example 7

[0122] The marker of any one or more of Examples 1 to 6, wherein the marker element is configured to slidably engage the cannula when each transformed arm of the plurality of arms is in the pre-deployment configuration.

[0123] Example 8

[0124] The marker of any one or more of Examples 1 to 7, wherein the plurality of arms comprises three or more arms.

[0125] Example 9

[0126] The marker of any one or more of Examples 1 to 8, wherein the marker element defines a plurality of release openings, each release opening being disposed between one of the plurality of arms, each release opening being configured to allow each arm to move relative to the base.

[0127] Example 10

[0128] The marker of any one or more of Examples 1 to 9, wherein the plurality of arms comprises a plurality of movable arms and a plurality of inactive arms, the plurality of movable arms being configured to transform from the pre-deployment configuration to the post-deployment configuration while the plurality of inactive arms remain substantially stationary.

[0129] Example 11

[0130] The marker of any one or more of Examples 1 to 10, wherein each of the plurality of arms is integral with the base.

[0131] Example 12

[0132] The marker of any one or more of Examples 1 to 11, wherein the base has a hollow interior and an open end, the open end of the base being configured to promote tissue ingrowth.

[0133] Example 13

[0134] The marker of any one or more of Examples 1 to 12, wherein the marker element comprises a surface treatment on one or more outer surfaces of the marker element, the surface treatment being configured to increase the echogenicity of the marker element.

[0135] Example 14

[0136] In the marker of Example 13, the surface treatment comprises a sandblasted surface.

[0137] Example 15

[0138] The marker of any one or more of Examples 1 to 14, wherein the marker element is configured as a bare marker element.

[0139] Example 16

[0140] A biopsy site marker comprises: a base; and an anchor portion extending from at least one side of the base portion, the anchor portion comprising a plurality of engagement arms, each engagement arm having a shaped position and a compressed position, each engagement arm being spread apart from each other engagement arm when in the shaped position, each engagement arm being configured to return from the compressed position to the shaped position when the anchor portion is exposed to a predetermined temperature.

[0141] Example 17

[0142] In the biopsy site marker of Example 16, the base includes a distal base and a proximal base, and each engagement arm of the plurality of engagement arms extends from the distal base to the proximal base.

[0143] Example 18

[0144] In the biopsy site marker of Example 16, one or more engagement arms of the plurality of engagement arms extend from proximal and distal sides of the base, and the base is located at the center between at least two engagement arms of the plurality of engagement arms.

[0145] Example 19

[0146] The biopsy site marker of any one or more of Examples 16 to 18, wherein the anchor portion defines a first diameter when each engagement arm is in the compressed position, and the anchor portion defines a second diameter when each engagement arm is in the fixed position, the second diameter being at least twice the first diameter.

[0147] Example 20

[0148] The biopsy site marker of any one or more of Examples 16 to 18, wherein the anchor portion defines a first diameter when each engagement arm is in the compressed position, and the anchor portion defines a second diameter when each engagement arm is in the fixed position, the second diameter being at least three times the first diameter.

[0149] Example 21

[0150] The biopsy site marker of any one or more of Examples 16 to 20 further includes a plurality of static arms, each static arm of the plurality of static arms being configured to remain in a static position relative to the engagement arm.

[0151] Example 22

[0152] In the biopsy site marker of Example 21, each of the plurality of static arms extends along a longitudinal axis defined by the biopsy site marker.

[0153] Example 23

[0154] In the biopsy site marker of Examples 21 or 22, each of the plurality of static arms defines a length that is shorter than a length defined by each of the plurality of articulated arms.

[0155] Example 24

[0156] In the biopsy site marker of Examples 21 or 22, each of the plurality of static arms defines a length that is longer than a length defined by each of the plurality of articulated arms.

[0157] Example 25

[0158] A biopsy site marker comprises: a marker element, the marker element defining a hollow cylindrical shape extending from a proximal end to a distal end, the marker element further defining a plurality of narrow slots extending longitudinally relative to a longitudinal axis of the marker element to define a plurality of active arms and a plurality of passive arms, each of the plurality of active arms being configured to move outwardly from the longitudinal axis defined by the marker element in response to heat at the biopsy site.

[0159] Example 26

[0160] In the biopsy site marker of Example 25, the plurality of slots extend inwardly toward a base disposed between at least two active arms and at least two passive arms.

[0161] Example 27

[0162] In the biopsy site marker of Example 25, the plurality of slots extend inwardly from the distal base to the proximal base to define each movable arm, such that each movable arm extends from the distal base to the proximal base.

[0163] Example 28

[0164] In the biopsy site marker of Example 27, the distal base and the proximal base each include a plurality of static anchors extending outwardly from the distal base and the proximal base, respectively.

[0165] Example 29

[0166] The biopsy site marker of any one or more of Examples 25 to 28, wherein the plurality of slots terminate in a release opening sized to allow the movable arm to move relative to a portion of the marker element.

[0167] Example 30

[0168] The biopsy site marker of any one or more of Examples 25 to 29, wherein the marker element comprises a single material, wherein the single material is nitinol.

[0169] Example 31

[0170] A biopsy marking system, the system comprising: a biopsy site marker of one or more of Examples 1 to 30; a marker delivery device, the marker delivery device comprising an introduction sleeve, a handle and a push rod, the introduction sleeve being configured to receive the marker, the push rod being configured to move relative to the handle to eject the marker from a marker outlet defined by the introduction sleeve.

[0171] V. Conclusion

[0172] It should be understood that any patent, publication, or other public material described as being incorporated herein by reference in whole or in part is only incorporated herein to the extent that the incorporated material does not conflict with pre-existing definitions, statements, or other public materials set forth in the present disclosure. Therefore, and to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof described as being incorporated herein but conflicting with pre-existing definitions, statements, or other public materials set forth herein is only incorporated to the extent that no conflict occurs between the incorporated material and the pre-existing public materials.

[0173] Although various embodiments of the present invention have been shown and described, the methods and systems described herein may be further modified by those of ordinary skill in the art by appropriate modifications without departing from the scope of the present invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those of ordinary skill in the art. For example, the above examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like are illustrative and not required. Therefore, the scope of the present invention should be considered in accordance with the following claims and should not be construed as limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A biopsy site marker, comprising: a marker element, the marker element comprising a base portion and an anchor portion, The anchor portion extends from the base portion, the anchor portion comprising a plurality of arms, one or more of the plurality of arms is configured to transform from a pre-deployment configuration to a post-deployment configuration in response to heat, When in the post-deployment configuration, each transformed arm of the plurality of arms extends outwardly from a longitudinal axis defined by the marker element.

2. The marker of claim 1, wherein each of the plurality of arms is configured to abut one or more adjacent arms when in the pre-deployment configuration.

3. A marker as described in claim 1 or 2, each arm of the plurality of arms is arranged in a circular pattern relative to the base.

4. A marker as described in any one or more of claims 1 to 3, each arm having a curved inner surface and a curved outer surface, and the curved inner surface and the curved outer surface of each arm in the multiple arms are configured to form a hollow cylindrical shape when the multiple arms are in the pre-deployment configuration.

5. A marker as described in any one or more of claims 1 to 4, wherein the base includes a first base and a second base, and one or more arms of the plurality of arms extend from the first base to the second base.

6. The marker of any one or more of claims 1 to 5, wherein each transformed arm of the plurality of arms defines a curved exponential or parabolic shaped profile when in the post-deployment configuration.

7. The marker of any one or more of claims 1 to 6, wherein the marker element is configured to slidably engage a cannula when each transformed arm of the plurality of arms is in the pre-deployment configuration.

8. A marker as described in any one or more of claims 1 to 7, wherein the plurality of arms comprises three or more arms.

9. A marker as described in any one or more of claims 1 to 8, wherein the marker element defines a plurality of release openings, each release opening being disposed between one of the plurality of arms, each release opening being configured to allow each arm to move relative to the base.

10. The marker of any one or more of claims 1 to 9, wherein the plurality of arms comprises a plurality of movable arms and a plurality of inactive arms, the plurality of movable arms being configured to transform from the pre-deployment configuration to the post-deployment configuration while the plurality of inactive arms remain substantially stationary.

11. A marker as described in any one or more of claims 1 to 10, each arm of the plurality of arms being integral with the base.

12. The marker of any one or more of claims 1 to 11, the base having a hollow interior and an open end, the open end of the base configured to promote tissue ingrowth.

13. The marker of any one or more of claims 1 to 12, the marker element comprising a surface treatment on one or more outer surfaces of the marker element, the surface treatment being configured to increase the echogenicity of the marker element.

14. The marker of claim 13, wherein the surface treatment comprises a sandblasted surface.

15. A marker as described in any one or more of claims 1 to 14, wherein the marker element is configured as a bare marker element.

16. A biopsy site marker, comprising: base; as well as an anchor portion extending from at least one side of the base portion, the anchor portion comprising a plurality of engagement arms, Each engagement arm has a shaped position and a compressed position, each engagement arm being spread apart from each other engagement arm when in the shaped position, Each engagement arm is configured to return from the compressed position to the set position when the anchor portion is exposed to a predetermined temperature.

17. The biopsy site marker of claim 16, the base comprising a distal base and a proximal base, each engagement arm of the plurality of engagement arms extending from the distal base to the proximal base.

18. The biopsy site marker of claim 16, one or more engagement arms of the plurality of engagement arms extending proximally and distally from the base, the base being centered between at least two engagement arms of the plurality of engagement arms.

19. The biopsy site marker of any one or more of claims 16 to 18, wherein the anchor portion defines a first diameter when each engagement arm is in the compressed position, and the anchor portion defines a second diameter when each engagement arm is in the fixed position, the second diameter being at least twice the first diameter.

20. The biopsy site marker of any one or more of claims 16 to 18, wherein the anchor portion defines a first diameter when each engagement arm is in the compressed position, and the anchor portion defines a second diameter when each engagement arm is in the fixed position, the second diameter being at least three times the first diameter.

21. The biopsy site marker of any one or more of claims 16 to 20, further comprising a plurality of static arms, each static arm of the plurality of static arms being configured to remain in a static position relative to the engagement arm.

22. The biopsy site marker of claim 21, each of the plurality of static arms extending along a longitudinal axis defined by the biopsy site marker.

23. The biopsy site marker of claim 21 or 22, each of the plurality of static arms defining a length that is shorter than a length defined by each of the plurality of articulated arms.

24. The biopsy site marker of claim 21 or 22, each of the plurality of static arms defining a length that is longer than a length defined by each of the plurality of articulated arms.

25. A biopsy site marker, comprising: a marker element defining a hollow cylindrical shape extending from a proximal end to a distal end, The marker element further defines a plurality of slots extending longitudinally relative to a longitudinal axis of the marker element to define a plurality of active arms and a plurality of passive arms, Each movable arm of the plurality of movable arms is configured to move outwardly from the longitudinal axis defined by the marker element in response to heat at a biopsy site.

26. The biopsy site marker of claim 25, the plurality of slots extending inwardly toward a base disposed between the at least two active arms and the at least two passive arms.

27. The biopsy site marker of claim 25, the plurality of slots extending inwardly from the distal base to the proximal base to define each movable arm, such that each movable arm extends from the distal base to the proximal base.

28. The biopsy site marker of claim 27, the distal base and the proximal base each comprising a plurality of static anchors extending outwardly from the distal base and the proximal base, respectively.

29. The biopsy site marker of any one or more of claims 25 to 28, the plurality of slots terminating in a release opening sized to allow the movable arm to move relative to a portion of the marker element.

30. The biopsy site marker of any one or more of claims 25 to 29, the marker element comprising a single material, the single material being Nitinol.

31. A biopsy marking system, the system comprising: (a) A biopsy site marker as described in one or more of Examples 1 to 30; (b) A marker delivery device, comprising an introduction sleeve, a handle and a push rod, wherein the introduction sleeve is configured to receive the marker, and the push rod is configured to move relative to the handle to eject the marker from a marker outlet defined by the introduction sleeve.

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