Biopsy site marker with expandable 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 distally from the base portion. The anchor portion includes a plurality of arms. Each arm of the plurality of arms is configured to transition from a pre-deployment configuration to a post-deployment configuration in response to heat. Each arm of the plurality of arms extends outwardly from a longitudinal axis defined by the marker element when the plurality of arms are in the deployed configuration.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 398,333, filed on August 16, 2022, entitled “Biopsy Site Marker Having Expandable Portion,” 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 where the biopsy tissue is removed after a breast biopsy is described in the following U.S. patents: US 6,083,524, issued on July 4, 2000, "Polymerizable biodegradable polymers including carbonate or dioxanone linkages"; US 6,162,241, issued on December 4, 2000, "Hemostatic tissue sealants"; US 6,270,464, issued on August 7, 2001, "Biopsylocalization method and device"; US 6,356,782, issued on March 12, 2002, "Subcutaneous cavity marking device and method"; US 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"; US 8,600,481, issued on December 3, 2013, "Subcutaneous cavity marking method and device"; device”; and US 8,939,910, issued January 27, 2015, “Method for enhancing ultrasound 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 depicted in dashed lines.

[0008] Figure 1 depicts a stereogram of an exemplary 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 's expanded configuration; and

[0013] Figure 5A , Figure 5B and Figure 5C shows exemplary aspects of placing another biopsy site marker according to aspects of the present disclosure;

[0014] Figure 6 depicts a perspective view of an exemplary marker delivery device;

[0015] Figure 7 Depicted Figure 6 a side cross-sectional view of a marker delivery device; and

[0016] Figure 8 Depicted is a cross-sectional view of a marker from Figure 6 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.

[0017] 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

[0018] 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.

[0019] 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.

[0020] 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 that the ultrasound view be distinguishable as a marker and not inadvertently identified as a new mass.

[0021] I. Exemplary Biopsy Site Markers for Limited Migration

[0022] 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 features outlined below are described herein, it should be understood that various alternative combinations may be used without departing from the basic principles described herein.

[0023] Figure 1An 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. In some versions, the marker (500) is similar to the marker (100) described in more detail below. For example, as with the marker (100), 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 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, marker (500) may include only marker element (512), omitting structures similar to carrier (120) described below. In other words, in some versions, marker (500) may be configured as a "naked" marker.

[0024] As described above, the present version of marker (500) is configured to transform from a pre-deployment configuration to a post-deployment configuration after deployment at a biopsy site. Marker (500) includes a base (520) and an anchor portion (540), wherein both base (520) and anchor portion (540) are defined by marker element (512). Base (520) defines a generally cylindrical shape. In the present version, base (520) is hollow and defines an open proximal end (522) (see Figure 4 ). In other versions, base (520) may be partially or substantially solid.

[0025] All edges of the base (520) may be of a non-invasive configuration. In other words, the base (520) generally does not include sharp edges or corners. Thus, the intersection of any given surface of the base (e.g., the distal end and the cylindrical exterior) may be rounded, chamfered, smoothed, beveled, or otherwise softened to smooth the contours of such intersection.

[0026] Anchor portion (540) extends distally from base portion (520), and the hollow interior of base portion (520) is open to the interior of anchor portion (540). As will be described in greater detail below, anchor portion (540) is generally configured to transition from a pre-deployment configuration to a post-deployment configuration in response to one or more environmental stimuli.

[0027] 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 exist even if the term "anchor" or similar terms are not directly used herein to refer to a feature. For example, in some cases, the open proximal end (522) of base (520) may also have an anchoring function by facilitating tissue growth into marker (500). In addition or alternatively, some versions of marker (500) may include a structure similar to carrier (120) (described below) that can expand within tissue and be used to further facilitate anchoring marker (500) within tissue.

[0028] The anchor portion (540) of this version includes a plurality of arms (542) oriented in a circular pattern. Although this version includes three arms (542), it should be understood that other suitable numbers of arms (542) may be used in other versions, such as two, four, five, etc. Each arm (542) is defined by a plurality of slots extending from the distal end of the marker element (512) to the base. As will be described in more detail below, the arms (542) 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.

[0029] Each arm (542) defines a substantially semi-cylindrical cross-sectional shape, such that each arm (542) can abut against each adjacent arm (542) to form a cylindrical shape corresponding to the shape of the base (520). Specifically, each arm (542) includes a curved inner surface (544) and a curved outer surface (546). Thus, when each arm (542) is positioned to abut against each adjacent arm (542), the curved surfaces (544, 546) together form a cylindrical inner and outer surface.

[0030] The proximal end of each arm (542) is fixed to the distal end of the base (520), so that each arm (542) extends distally from the distal end of the base (520). In this version, each arm (542) is integral with the base (520), although in other versions, each arm (542) can be fixedly fixed to the base (520).

[0031] A portion of the base (520) and / or each arm (542) defines a plurality of release openings (560). Each release opening (560) defines 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) 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 arm (542) relative to the base (520) and each adjacent arm (542).

[0032] The distal end of each arm (542) includes a distal tip (562) having a blunt configuration. Specifically, all edges of each arm (542) that intersect at the distal tip (562) are generally rounded or otherwise fused together so that the distal tip (562) of each arm (542) is generally in an atraumatic configuration. In some versions, such a configuration may be desirable to facilitate movement of the arm (542) through tissue during or after deployment. For example, during deployment, the blunt configuration of each distal tip (562) may be suitable for facilitating easy movement through various instruments, devices, and / or tissues. Similarly, after deployment, the blunt configuration of each distal tip (562) may facilitate movement of the arm (542) through tissue, thereby not impeding movement and not unnecessarily damaging surrounding tissue.

[0033] In this version, each arm (542) is substantially identical to all other arms (542), except for the position of each arm (542) relative to the base (520). It should be understood that in other versions, one or more arms (542) may be different from other arms (542). For example, in some versions, one or more arms (542) may have a longer or shorter length relative to another arm (542). In addition, or alternatively, in some versions, one or more arms (542) may define a different shape relative to another arm (542). In view of the teachings herein, other other variations in the configuration of each arm (542) relative to other arms (542) will be apparent to those of ordinary skill in the art.

[0034] As described above, arms (542) may be movable between a pre-deployment configuration and a post-deployment configuration. Figure 1 and Figure 2Arms (542) are shown in a post-deployment state. In this state, each arm (542) is bent outward from the longitudinal axis defined by marker element (512). In other words, arms (542) can be spread outward relative to each other. In some versions, such outward extension, bending, and / or spreading of arms (542) can cause the diameter of marker (500) to be twice as large as when in the pre-deployment configuration. In other versions, such outward extension, bending, and / or spreading of arms (542) can cause the diameter of marker (500) to be three times as large as when in the pre-deployment configuration. Figure 2 As can be most clearly seen in , the particular outward curvature of each arm (542) may be non-linear, with the curvature initially having a relatively low slope, followed by a relatively high slope, and then a gradually decreasing slope toward alignment with the longitudinal axis defined by the marker element (512). In other words, the outward curvature of each arm (542) may initially define a relatively concave (relative to the exterior of a given arm (542)) portion proximate the base (520) and then transition to a relatively convex portion proximate the distal tip (562).

[0035] As described above, arms (542) of this version are integral with base (520). Marker element (512) is thus 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 marker element (512) can be used to allow arms (542) to be converted from a pre-deployment configuration to a post-deployment configuration, wherein heat from the patient's surrounding tissue at the biopsy site is used to initiate the conversion.

[0036] 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.

[0037] Back to Figure 1 , the entire outer surface of the marker element (512) may include a surface treatment (ST). Figure 1In the embodiment of the present invention, the surface treatment (ST) has the appearance of covering a portion of the marker element (512), it should be understood that this appearance is for illustrative purposes only, and in some versions, the surface treatment (ST) covers the entire surface of the marker element (512). 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 multiple microspheres and a polymer adhesive. This 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 obvious to those of ordinary skill in the art in view of the teachings of this article.

[0038] FIG. 3A to FIG. 4 Various aspects of using a marker element (512) to mark tissue are shown. Figure 3A As can be seen, the marker element (512) can initially begin with the arms (542) in a pre-deployment configuration. In the pre-deployment configuration, the arms (542) can be compressed inwardly toward the longitudinal axis defined by the marker element (512) so that each arm (542) abuts each adjacent arm (542). When compressed as shown, the arms (542) form a generally hollow cylindrical shape corresponding to the shape of the base (520). Thus, when the arms (542) are in the pre-deployment configuration, the marker element (512) can define a generally cylindrical shape.

[0039] 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 arms (542) of the shape memory alloy. The arms (542) may then be subsequently compressed during manufacturing into a Figure 3A The pre-deployment shape is shown to prepare marker element (512) for deployment at a biopsy site.

[0040] Regardless of how the arms (542) are transformed to the pre-deployment configuration, the marker element (512) can be introduced into a biopsy site of a patient while in the pre-deployment configuration. The pre-deployment configuration may be suitable for introduction at a biopsy site because the compact and uniform shape may facilitate use with instruments similar to the marker delivery device (150) described in more detail below. The compact and uniform shape may also facilitate movement of the marker element (512) through tissue for placement at a biopsy site.

[0041] Once the marker element (512) is positioned as desired, the marker element (512) can absorb heat from tissue near the biopsy site and increase the temperature. The temperature of the marker element (512) can be increased 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 arm (542). Therefore, heat from the patient can initiate the conversion of the arm (542) from the pre-deployment configuration to the post-deployment configuration.

[0042] from Figure 3B and Figure 4 As can be most clearly seen in FIG. 5 , the transition to the deployed configuration includes the arms (542) moving away from the longitudinal axis defined by the marker element (512). In other words, the arms (542) may expand or splay outward relative to each other. During this transition, the 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.

[0043] II. Exemplary Markers

[0044] Aspects presented herein relate to methods for manufacturing a FIG. 5A to FIG. 5C The apparatus and procedure for percutaneously marking a biopsy cavity (10) with surrounding tissue (30) are shown. Figure 5A As can be seen in the figure, the marker (100) (or alternatively, the marker (500)) can first be placed in the biopsy cavity (10) to facilitate repositioning the biopsy site. Although the marker (100) is described separately herein, it should be understood that the marker (100) can include various features of the above-mentioned marker (500), such as the anchor portion (540), the arm (542), the base (520), etc. The marker (100) can include a carrier (120) and a marker element (12). As described above, the carrier (120) can be easily incorporated into the marker (500) or the marker (100). The carrier (120) generally includes a bioabsorbable marker material (122). Therefore, the carrier (120) is generally 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 greater detail below, the marker material (122) is generally bioabsorbable, such that the marker material (122) is generally absorbed 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 comprise other known bioabsorbable materials.

[0045] 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. Additionally, as described above, in some versions marker element (12) may include features of a marker element (12), such as base (520), anchor portion (540), arm (542), and the like.

[0046] Once positioned at the biopsy site within the patient, the marker material (122) is typically capable of expanding. Figure 5B and Figure 5C 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.

[0047] The marker (100) (or alternatively, the marker (500)) can be inserted into the body through an opening in the body cavity (30) surgically, or through minimally invasive surgery using a device such as a catheter, an inserter, or a similar type of insertion device. This insertion can be performed 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 marker (100) (or alternatively, the marker (500)).

[0048] 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.).

[0049] 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.

[0050] 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.

[0051] III. Exemplary Marker Delivery Devices

[0052] In some versions, it may be desirable to deploy any one or more of the markers (100, 500) described above within a body cavity (30) using certain marker delivery devices. For example, Figure 6 and Figure 7 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.

[0053] 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 Figure 7The 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).

[0054] 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).

[0055] Figure 7 A cross-sectional view of a distal portion of a marker delivery device (150) is shown. As can be seen, a biopsy marker (300) similar to the markers (100, 500) described above is disposed within the interior lumen (165) of the cannula (162). Although the marker (300) is shown in this version, the depiction of the marker (300) is for illustrative purposes only, and in some versions, the marker (100, 500) may be used to supplement or replace the marker (300). In this version, the marker (300) may include a biodegradable or otherwise absorbable marker material (306), a generally cylindrically shaped body such as collagen, a hydrogel, or the like, and a metallic, substantially radiopaque permanent marker or marker element (310) (shown in phantom) disposed within or otherwise carried by the marker material (306).

[0056] 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.

[0057] 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 Figure 7 shown.

[0058] In this version, distal tip (172) extends from the distal end of cannula (162) and is rounded, as shown. Figure 7 See Figure 7 , 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).

[0059] 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 Figure 7 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). Figure 7 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).

[0060] like Figure 7 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 Figure 7 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.

[0061] like Figure 7As 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).

[0062] refer to Figure 8 The marker delivery device (150) is used to deploy the marker (300) (or alternatively, any one or more of the markers (100, 500)) to mark a biopsy location within a patient. Figure 8 , 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.

[0063] Figure 8The 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). Figure 8 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 cause the marker (300) (or alternatively, any one or more of the markers (100, 500) to be deployed upward along the ramp surface (212), through the opening (164), and then through the lateral hole (414) into the biopsy cavity.

[0064] IV. Exemplary Combinations

[0065] 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.

[0066] Example 1

[0067] A biopsy site marker comprises: a marker element, the marker element comprising a base and an anchor portion, the anchor portion extending distally from the base, the anchor portion comprising a plurality of arms, each of the plurality of arms being configured to transform from a pre-deployment configuration to a post-deployment configuration in response to heat, each of the plurality of arms extending outwardly from a longitudinal axis defined by the marker element when the plurality of arms are in the post-deployment configuration.

[0068] Example 2

[0069] 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.

[0070] Example 3

[0071] The marker of Example 1 or 2, wherein each of the plurality of arms is arranged in a circular pattern relative to the base.

[0072] Example 4

[0073] 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.

[0074] Example 5

[0075] In the marker of Example 4, the curved inner surface and the curved outer surface of each arm of the plurality of arms are configured to form a hollow cylindrical shape when the plurality of arms are in the pre-deployment configuration.

[0076] Example 6

[0077] The marker of any one or more of Examples 1 to 5, when in the post-deployment configuration, each of the plurality of arms defines a curved profile having an initially increasing slope followed by a decreasing slope as each arm extends distally from the base.

[0078] Example 7

[0079] The marker of any one or more of Examples 1-6, wherein the marker element is configured to slidably engage the cannula when each arm of the plurality of arms is in the pre-deployment configuration.

[0080] The marker of any one or more of Examples 1 to 7, wherein the plurality of arms comprises three arms.

[0081] Example 9

[0082] 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.

[0083] Example 10

[0084] In the marker of Example 9, each release opening defines a teardrop shape.

[0085] Example 11

[0086] The marker of any one or more of Examples 1 to 10, wherein each of the plurality of arms is integral with the base.

[0087] Example 12

[0088] The marker of any one or more of Examples 1 to 11, wherein the base has a hollow interior and an open proximal end, the open proximal end of the base being configured to promote tissue ingrowth.

[0089] Example 13

[0090] 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.

[0091] Example 14

[0092] In the marker of Example 13, the surface treatment comprises a sandblasted surface.

[0093] Example 15

[0094] The marker of any one or more of Examples 1 to 14, wherein the marker element is configured as a bare marker element.

[0095] Example 16

[0096] A biopsy site marker comprises: a base; and an anchor portion extending from the base, the anchor portion comprising a plurality of outriggers, each outrigger having a shaped position and a compressed position, each outrigger being spread apart from each other outrigger when in the shaped position, each outrigger being configured to return from the compressed position to the shaped position when the anchor portion is exposed to a predetermined temperature.

[0097] Example 17

[0098] The biopsy site marker of Example 16, wherein the marker defines a bell shape when each outrigger is in the shaped position.

[0099] Example 18

[0100] In the biopsy site marker of example 16 or 17, the anchor portion defines a first diameter when each outrigger is in the compressed position, and the anchor portion defines a second diameter when each outrigger is in the shaped position, the second diameter being at least twice the first diameter.

[0101] Example 19

[0102] In the biopsy site marker of example 16 or 17, the anchor portion defines a first diameter when each outrigger is in the compressed position, and the anchor portion defines a second diameter when each outrigger is in the shaped position, the second diameter being at least three times the first diameter.

[0103] Example 20

[0104] 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 slots extending from the distal end to a base to define a plurality of arms, each of the plurality of arms being configured to move outwardly from a longitudinal axis defined by the marker element in response to heat at the biopsy site.

[0105] Example 21

[0106] In the biopsy site marker of Example 20, the proximal end and the distal end of the marker element have rounded edges.

[0107] Example 22

[0108] In the biopsy site marker of examples 20 or 21, the plurality of slots terminate in a release opening sized to allow movement of the arm relative to a portion of the marker element.

[0109] Example 23

[0110] The biopsy site marker of any one or more of Examples 20 to 22, wherein the marker element comprises a single material, wherein the single material is Nitinol.

[0111] V. Conclusion

[0112] 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.

[0113] 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 distally from the base portion, the anchor portion comprising a plurality of arms, Each arm of the plurality of arms is configured to transform from a pre-deployment configuration to a post-deployment configuration in response to heat, When the plurality of arms are in the post-deployment configuration, each 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 claimed in any one or more of claims 1 to 3, each arm having a curved inner surface and a curved outer surface.

5. The marker of claim 4, wherein the curved inner surface and the curved outer surface of each of the plurality of arms are configured to form a hollow cylindrical shape when the plurality of arms are in the pre-deployment configuration.

6. A marker as described in any one or more of claims 1 to 5, wherein when in the post-deployment configuration, each of the plurality of arms defines a curved profile having an initially increasing slope followed by a decreasing slope as each arm extends distally from the base.

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 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 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 Example 9, wherein each release opening defines a teardrop shape.

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 proximal end, the open proximal 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: (a) Base; as well as (b) an anchor portion extending from the base, the anchor portion comprising a plurality of outriggers, each outrigger having a shaped position and a compressed position, each outrigger being spread apart from each other outrigger when in the shaped position, each outrigger being configured to return from the compressed position to the shaped position when the anchor portion is exposed to a predetermined temperature.

17. The biopsy site marker of claim 16, said marker defining a bell shape when each outrigger is in said shaped position.

18. The biopsy site marker of claim 16 or 17, wherein the anchor portion defines a first diameter when each outrigger is in the compressed position, and wherein the anchor portion defines a second diameter when each outrigger is in the shaped position, the second diameter being at least twice the first diameter.

19. The biopsy site marker of claim 16 or 17, wherein the anchor portion defines a first diameter when each outrigger is in the compressed position, and wherein the anchor portion defines a second diameter when each outrigger is in the shaped position, the second diameter being at least three times the first diameter.

20. 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 from the distal end to the base to define a plurality of arms, Each arm of the plurality of arms is configured to move outwardly from a longitudinal axis defined by the marker element in response to heat at the biopsy site.

21. The biopsy site marker of claim 20, the proximal end and the distal end of the marker element having rounded edges.

22. The biopsy site marker of claim 20 or 21, the plurality of slots terminating in a release opening sized to allow movement of the arm relative to a portion of the marker element.

23. The biopsy site marker of any one or more of claims 20 to 22, the marker element comprising a single material, the single material being Nitinol.

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