Biopsy site marker with expandable mesh

Abstract

A biopsy site marker includes a carrier and a marker element. The carrier is configured to expand the diameter in response to humidity. The marker element includes a base. The base defines a plurality of interconnected legs. Each leg is configured to move relative to the other leg to allow the marker element to move from a pre-deployment configuration to a post-deployment configuration. The base portion is disposed around an outer surface of the carrier. The carrier is configured to drive the marker element to move from the pre-deployment configuration to the post-deployment configuration.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 354,952, filed on June 23, 2022, entitled “Biopsy Site Marker with Expandable Mesh,” the disclosure of which is incorporated herein by reference. Background Art

[0003] A breast biopsy may be performed because of an irregular mammogram and palpable abnormalities. Biopsies can include surgical excisional biopsies as well as 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 surgical procedures (e.g., 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 the surgical procedure. Imaging systems such as ultrasound, magnetic resonance imaging (MRI), or X-ray may be used to locate the biopsy site. To assist in relocating the biopsy site, markers may be placed at the time of 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. Patent No. 6,083,524, entitled “Polymerizable biodegradable polymers including carbonate or dioxanone linkages,” issued on July 4, 2000; U.S. Patent No. 6,162,241, entitled “Hemostatic tissue sealants,” issued on December 4, 2000; U.S. Patent No. 6,270,464, entitled “Biopsy localization method and device,” issued on August 7, 2001; U.S. Patent No. 6,356,782, entitled “Subcutaneous cavity marking device and method,” issued on March 12, 2002; U.S. Patent No. 6,356,782, entitled “Methods of using in situhydration of hydrogel articles for sealing or augmentation of tissue No. 6,605,294, entitled “Subcutaneous cavity marking device,” issued on December 3, 2013; and No. 8,939,910, entitled “Method for enhancing ultrasound visibility of hyperechoic materials,” issued on January 27, 2015. All of these U.S. 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 features into the marker so that the marker remains in a fixed position over time.

[0006] While several systems and methods have been made and used to mark biopsy sites, the inventors believe that the invention described in the appended claims has not previously been made or used. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] While the specification concludes with claims that particularly point out and distinctly claim the invention, the inventors believe 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 as depicted in dashed lines.

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

[0009] Figure 2 Depicted with Figure 1 A perspective view of an example of a marker delivery device for use with a marker;

[0010] Figure 3A Describes the use Figure 2 The marker delivery device will Figure 1 A perspective view of a marker inserted into tissue, the marker being in a pre-deployment configuration;

[0011] Figure 3B Describes the use Figure 2 The marker delivery device will Figure 1 Another perspective view of a marker inserted into tissue, the marker being in an expanded configuration;

[0012] Figure 3C Describes the Figure 1 another perspective view of a marker inserted into tissue, the marker being in a post-deployment configuration;

[0013] Figure 4 A perspective view depicting another example of a biopsy site marker;

[0014] Figure 5A Describes the use Figure 2 The marker delivery device will Figure 4 A perspective view of a marker inserted into tissue, the marker being in a pre-deployment configuration;

[0015] Figure 5B Describes the use Figure 2 The marker delivery device will Figure 4 Another perspective view of a marker inserted into tissue, the marker being in an expanded configuration;

[0016] Figure 6 A perspective view depicting yet another example of a biopsy site marker;

[0017] Fig. 7A Describes the use Figure 2 The marker delivery device will Figure 6 a perspective view of a marker inserted into tissue, the marker being in a pre-deployment configuration; and

[0018] Figure 7B Describes the use Figure 2 The marker delivery device will Figure 6 Another perspective view of a marker inserted into tissue, the marker being in an expanded configuration.

[0019] The drawings are not intended to be limiting in any way, 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 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

[0020] 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 not restrictive in nature.

[0021] 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.

[0022] 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. In general, 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.

[0023] I. Example Systems with Limited Mobility Markers

[0024] In some biopsy site marker versions, it may be desirable to include certain features within the marker or within portions of the marker to reduce the tendency of the marker to migrate when it is placed within the tissue. For example, some markers may be prone to migration after being placed at the biopsy site due to tissue movement during the intermediate time between marker placement and subsequent follow-up procedures. In addition or as an alternative, structures within the tissue may increase the tendency of the marker to migrate. An example of such a structure may include, for example, a channel formed for collecting biopsy samples and / or placing markers. Therefore, such markers and / or the surrounding environment may pose challenges to accurately identifying the biopsy site during subsequent follow-up procedures. Therefore, it may be desirable to incorporate features into the marker to assist in maintaining the marker in a substantially fixed position within the tissue 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.

[0025] A. Example of a biopsy site marker with expandable mesh

[0026] Figure 1 An exemplary marker (100) is shown that is generally configured to expand from a pre-deployment configuration to a post-deployment configuration to anchor or otherwise secure the marker (100) at a predetermined location within tissue. The present version of the marker (100) includes a marker element (112). In some versions, the marker element (112) can generally be configured to be non-bioresorbable and radiopaque and / or echogenic to enhance visualization using one or more visualization modes.

[0027] In addition, although not shown, it should be understood that in some versions, the marker (100) may include a structure that may be referred to as a "carrier." By way of example only, such a carrier may include certain bioabsorbable features that may be absorbed into the tissue over time. In some versions, the marker element (112) may be embedded within such a carrier. In such versions, one or more portions of the marker element (112) may protrude outward from such a carrier. In other versions, the marker element (112) may surround such a carrier, and the carrier acts as a core. In versions that include such a carrier, the carrier may be formed in a shape described in more detail below, or alternatively may be configured as a coating. In other versions, the marker (100) may include only the marker element (112), omitting additional structures such as a carrier. In other words, in some versions, the marker (100) may be configured as Figure 1. It will be appreciated that in versions using elements such as carriers, such carriers may be configured to provide enhanced visualization in certain imaging modes. By way of example only, such carriers may include echogenic features to enhance visibility of the marker (100) under ultrasound.

[0028] like Figure 1 As best shown in , the marker element (112) includes a body (114) and a plurality of anchors (120) extending outwardly from one or more portions of the body (114). The body (114) is generally configured to easily expand and contract between different positions, as will be described in more detail below. The body (114) in this version includes a plurality of interconnected legs (116). The legs (116) can generally be arranged to form a repeating pattern of one or more predetermined shapes. For example, in this version, the legs (116) form a plurality of repeated triangular or zigzag shapes. In other versions, a variety of other alternative shapes can be used alone or in combination. Examples of suitable shapes formed by the legs (116) can include triangles, zigzags, squares, rectangles, ellipses, circles, octagons, and the like. In addition, although each leg is shown as a generally straight wire segment, it should be understood that in other versions, each leg (116) can be curved to provide different irregular shapes.

[0029] Regardless of the specific shape formed by the legs (116), it should be understood that the legs (116) are generally configured to facilitate deformation of the marker element (112) between one or more different positions. Therefore, the specific shape formed by the legs (116) is generally configured to allow at least some movement of each leg (116). It may be desirable for each leg (116) to be flexed to a certain extent relative to the other legs (116) to allow the overall deformation of the marker element (112) and / or one or more portions of the marker element (112) to be deformed. It may also be desirable for the specific shape formed by the legs (116) to provide a relatively large coverage area and / or surface area for the marker element (112) using a relatively small volume of material. It may also be desirable for the specific shape formed by the legs (116) to provide an opening in the surface of the marker element (112) to facilitate tissue growth, thereby providing additional tissue anchoring and / or fixation over time.

[0030] The legs (116) are interconnected to form the overall shape of the marker element (112). In this version, the marker element (112) is formed in the shape of a hollow cylinder (e.g., a stent-shaped, straight or tapered). As will be described in more detail below, it may be desirable that this particular shape facilitates the deployment of the marker (100) at the biopsy site. Although both ends of the marker element (112) are open in this version, in other versions, one or both ends may be closed. In other versions, a variety of alternative shapes may be used. Suitable alternative shapes of the marker element (112) may include a truncated cone, a sphere, an egg shape, an annular shape, and the like.

[0031] The marker element (112) comprises a material that is generally deformable and biocompatible. As will be described in more detail below, the marker element (112) is generally configured to be manipulable into various predetermined shapes and then maintain such predetermined shapes over time. Therefore, the marker element (112) may include a material having at least some ductility. In other words, the marker element (112) may be configured to be shaped by an external force above a predetermined threshold; and also configured to maintain a predetermined shape in response to an external force below a predetermined threshold. Examples of suitable materials may include, for example, stainless steel, platinum chromium, cobalt chromium, polymers, combinations thereof, and the like. In other versions, the marker element (112) may include nitinol or one or more portions of nitinol. In such versions, the nitinol material may provide at least some shape memory properties, wherein the marker element (112) may change from one shape or configuration to another shape or configuration in response to heat or other stimulation from tissue. Regardless of the specific material used, in some versions, one or more surfaces of such a material may be etched with an echogenic pattern to enhance detection of the marker element (112) under ultrasound.

[0032] As described above, the marker element (112) includes a plurality of anchors (120) extending outwardly from the body (114). Each anchor (120) is generally configured to engage with tissue to increase the tendency of the marker element (112) to remain in a fixed position within the tissue. In this version, each anchor (120) is formed as a generally straight wire segment extending from one or more legs (116). Although the anchors (120) of this version are generally straight, in other versions, the anchors (120) may be curved or various alternative shapes. In addition, although not shown, in some versions, the anchors (120) may include barbs or other tissue engagement features to further facilitate engagement of the anchors (120) with the tissue.

[0033] Each anchor (120) of this version is generally at an angle relative to the longitudinal axis of the marker element (112). The specific angle used by each anchor (120) may vary from all anchors (120) to each anchor (120). For example, in some versions, all anchors (120) may be oriented at an angle between about 30° and 60° relative to the longitudinal axis of the marker element (112). In such versions, the specific angle used may be substantially the same (e.g., about 45°) for all anchors (120). In other versions, each anchor (120) (or a group of anchors (120)) may have different angles relative to other anchors (120).

[0034] The marker element (112) of this version includes four anchors (120), but other suitable numbers of anchors (120) may be used in other versions. In this configuration, the anchors (120) are arranged at opposite ends of the marker element (112). In other versions, various alternative anchor (120) configurations may be used depending on the specific number of anchors (120) used. For example, in some versions, eight anchors (120) may be used, each of which is on an opposite section of the marker element (112). In other versions, two anchors (120) may be used, each of which is on an opposite end of the marker element (112). In other versions, the anchors (120) may be omitted entirely.

[0035] B. Examples of Marker Delivery Devices

[0036] In some versions, it may be desirable to deploy marker (100) (or other markers described herein) within a body lumen using certain marker delivery devices. Figure 2 An example marker delivery device (150) is shown that includes an elongated outer sleeve (162) having a marker outlet, such as a distal opening (164) formed in the distal end of the sleeve (162). Thus, the present version of the marker delivery device (150) is configured as an end-deployed device. However, it should be understood that in other versions, a side-deployed device may be used, with a lateral opening disposed proximal to the distal end and on one side of the sleeve (162).

[0037] A grip (166) may be provided at the proximal end of the cannula (162). A push rod (168) may be provided, wherein the push rod (168) extends coaxially in 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 distal opening (164). The push rod (168) may have sufficient rigidity when compressed to push the marker out of the inner lumen of the cannula (162) through the distal opening (164), but is relatively flexible when bent. A plunger (170) may be coupled to the proximal end of the push rod (168) to push the rod (168) distally in the cannula (162) to deploy the marker outside the cannula (162).

[0038] The user can grasp the grip (166) with two fingers and can push the plunger (170) with the thumb of the same hand so that the marker delivery device (150) is operated by a single hand of the user. To facilitate single-handed use, a spring (172) or other resilient feature can be provided around the rod (168) between the grip (166) and the plunger (170) to bias the rod (168) proximally relative to the grip (166) and the cannula (162).

[0039] Sleeve (162) can be formed from any suitable metallic or non-metallic material. In some versions, sleeve (162) is formed from a thin-walled hollow tube formed from a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as polyether block amide (PEBA), such as known by the trade name PEBAX. Sleeve (162) can be formed from PEBAX and can be substantially transparent to visible light and X-rays.

[0040] This version of the marker delivery device (150) also includes a deployment balloon (180) disposed at the distal end of the push rod (168). It should be understood that the deployment balloon (180) is merely optional and may be omitted in some versions. For example, when the marker delivery device (150) is used in combination with a marker similar to the marker (100) described above, it may be desirable to deploy the balloon (180) to facilitate expansion of the marker (100) from a pre-deployment configuration to a post-deployment configuration, as described in more detail below. However, when the marker delivery device (150) is used in combination with other markers that do not require expansion or are self-expanding, the deployment balloon (180) may be omitted and the push rod (168) may be used to push such markers through the distal opening (164).

[0041] In versions of the marker delivery device (150) that include a deployment balloon (180), the deployment balloon (180) can be configured to apply a force to a marker similar to the marker (100) described above to deform certain elements of the marker. Thus, the deployment balloon (180) of this version can be configured as a non-flexible balloon to have sufficient strength to withstand the pressure associated with applying a force on an element such as the marker (100).

[0042] Although not shown, it should be understood that the deployment balloon (180) can be inflated by a variety of mechanisms. For example, in some versions, the push rod (168) can include a lumen that is configured to allow fluid to be injected into the deployment balloon (180) via the lumen. In such examples, fluid injection can be performed by means of a variety of mechanisms (such as syringes, fluid dispensing devices, etc.). In addition, in some versions, the fluid injection can be connected to the plunger (170) so that the fluid injection can occur automatically when the plunger (170) is actuated. For those of ordinary skill in the art, in view of the teachings herein, various alternative mechanisms for the expansion of the deployment balloon (180) will be apparent.

[0043] C. Exemplary Use of Biopsy Site Markers and Marker Delivery Devices

[0044] FIG. 3A to FIG. 3C An exemplary use of a marker (100) in combination with a marker delivery device (150) to deploy the marker (100) within tissue is shown. In this use, the marker (100) can be deployed at a biopsy site, although in other uses the marker (100) can also be deployed in a variety of tissue features. Prior to use, the marker (100) can be inserted onto a deployment balloon (180) of the marker delivery device (150). Both the marker (100) and the deployment balloon (180) can then be disposed within a cannula (162) of the marker delivery device (150) to initially insert the cannula (162) into the tissue.

[0045] In this application, the marker delivery device (150) may be first placed at the biopsy site. Figure 3A As shown in , placement at the biopsy site can be performed by inserting a cannula (162) into a tissue tube or passage formed by a biopsy needle. Thus, the marker delivery device (150) can be inserted after removing the biopsy needle and / or other components associated with the biopsy needle (such as, a targeting sleeve, an introducer, etc.). In other uses, the marker delivery device (150) can be used in combination with a biopsy needle, a targeting sleeve, an introducer, or other components. It may be desirable to use such additional components to maintain a tissue tube or passage to facilitate insertion of the cannula (162). It may also be desirable to use such additional components to more easily identify the location of the biopsy site, thereby facilitating accurate placement of the marker (100) at the biopsy site.

[0046] Once cannula (162) of marker delivery device (150) is inserted into tissue, plunger (170) may be used to actuate push rod (168). Figure 3A As best shown in FIG. 1 , such actuation may cause push rod (170) to extend the combination of deployment balloon (180) and marker (100) out of distal opening (164) of cannula (162) and into position at the biopsy site. At this point, the position of marker (100) may be confirmed using any suitable form of visualization technology (such as ultrasound, X-ray, MRI, etc.).

[0047] Once marker (100) is positioned as desired, deployment balloon (180) may be used to move marker element (112) from Figure 3A The pre-deployment configuration shown in Figure 3B and Figure 3C The post-deployment configuration shown in . Figure 3B As best shown in , the deployment balloon (180) may be inflated or otherwise expanded to apply a force to the marker element (112). The force may also cause the marker element (112) to expand by deforming the shape formed by the legs (116). The expansion may continue until one or more legs (116) and / or anchors (120) engage the surrounding tissue, thereby retaining the marker (100) at a desired location within the tissue.

[0048] Once the deployment balloon (180) has been expanded to manipulate the marker element (112) into the post-deployment configuration, the deployment balloon (180) may be deflated. The marker delivery device (150) may be removed from the tissue, such as Figure 3C As shown in , the marker (100) is left in place at the biopsy site. Due to the configuration of the marker element (112) described above, the marker element (112) can remain in the post-deployment configuration even after the deployment balloon (180) is removed. The marker element (112) can maintain this configuration over time, thereby maintaining the position of the marker (100) at the biopsy site for subsequent follow-up procedures.

[0049] II. Example Biopsy Site Marker with Expandable Core

[0050] Figure 4An example of an alternative marker (200) similar to the marker (100) described above is shown. For example, as with the marker (100) described above, the marker (200) is typically configured to expand from a pre-deployment configuration to a post-deployment configuration, thereby anchoring or otherwise fixing the marker (200) at a predetermined location within the tissue. However, unlike the marker (100) described above, the present version of the marker (200) is typically self-expandable, such that an external structure such as a deployment balloon (180) may not be required to initiate the transition from the pre-deployment configuration to the post-deployment configuration. In some cases, it may be desirable that the self-expanding mechanism described herein allow the marker (200) to be used with a variety of deployment devices having or not having a structure similar to the deployment balloon (180). As will be described in more detail below, it may be desirable that the self-expanding mechanism described herein enhances the visualization of the marker (200) in certain circumstances.

[0051] As with the above-described marker (100), the present version of the marker (200) includes a marker element (212). The present version of the marker element (212) is substantially similar to the above-described marker element (112). For example, similar to the above, the marker element (212) can generally be configured to be non-bioabsorbable and radiopaque and / or echogenic to enhance visualization using one or more visualization modes.

[0052] As with the marker element (112) described above, the marker element (212) of this version includes a body (214) and a plurality of anchors (220) extending outwardly from one or more portions of the body (214). The body (214) is substantially similar to the body (114) described above. For example, the body (214) is generally configured to easily expand and contract between different positions, as will be described in more detail below. As with the body (114) described above, the body (214) of this version includes a plurality of interconnected legs (216) that can form a variety of repeating shapes and / or patterns.

[0053] As with the above-described legs (116), the legs (216) are typically configured to facilitate deformation of the marker element (212) between one or more different positions. Thus, the specific shape formed by the legs (216) is typically configured to allow at least some movement of each leg (216). It may be desirable for each leg (216) to be flexed to a certain degree relative to the other legs (216) to allow for overall deformation of the marker element (212) and / or deformation of one or more portions of the marker element (212). It may also be desirable for the specific shape formed by the legs (216) to provide a relatively large coverage area and / or surface area for the marker element (212) using a relatively small volume of material. It may also be desirable for the specific shape formed by the legs (216) to provide an opening within the surface of the marker element (212) to facilitate tissue growth, thereby providing additional tissue anchoring and / or fixation over time.

[0054] As with the above-described legs (116), the legs (216) of this version are interconnected to form the general shape of the marker element (212). Similar to the above, the marker element (212) is formed in the shape of a hollow cylinder (e.g., a bracket-shaped, straight or tapered). Although both ends of the marker element (212) are open in this version, in other versions, one or both ends may be closed. In other versions, a variety of alternative shapes may be used. Suitable alternative shapes for the marker element (212) may include a truncated cone, a sphere, an egg shape, an annular shape, and the like.

[0055] The marker element (212) also includes a plurality of anchors (220) that are substantially similar to the anchors (120) described above. As with the anchors (120), the anchors (220) of this version extend outwardly from the body (214) and are generally configured to engage with tissue to increase the tendency of the marker element (212) to remain in a fixed position within the tissue. Each anchor (220) is formed as a generally straight wire segment extending from one or more legs (216). Although the anchors (220) of this version are generally straight, in other versions, the anchors (220) may be curved or various alternative shapes. Additionally, although not shown, in some versions, the anchors (220) may include barbs or other tissue engagement features to further facilitate engagement of the anchors (220) with tissue.

[0056] As with each anchor (120) described above, each anchor (220) of this version is generally angled relative to the longitudinal axis of the marker element (212). Similar to the above, the specific angle used for each anchor (220) may vary for all anchors (220) or for each anchor (220). Additionally, while the marker element (212) of this version includes four anchors (220), any other suitable number of anchors (220) may be used.

[0057] Unlike the above-described marker (100), the present version of the marker (200) includes a carrier (230) in addition to the marker element (212). The carrier (230) is generally configured to expand within the tissue to apply a force to the marker element (212), thereby causing the marker element (212) to transition from a pre-deployment configuration to a post-deployment configuration. In addition, the carrier (230) may generally be configured to enhance the visibility of the marker (200) under certain visualization modes (such as ultrasound visualization).

[0058] The carrier (230) of this version includes a bioabsorbable material that can be configured to be absorbed into the tissue after the marker (200) is placed at the biopsy site. The material of the carrier (230) is also configured to expand or swell after the marker (200) is placed at the biopsy site. In some versions, the material of the carrier (230) can be configured to expand two to three times or more relative to the initial size. As will be described in more detail below, these properties may be desirable to allow the carrier (230) to drive the marker element (212) from a pre-deployment configuration to a post-deployment configuration. Examples of suitable materials for the carrier (230) can include collagen, hydrogels, combinations of collagen and hydrogels, and the like. Although not shown, it should be understood that in some versions, the material of the carrier (230) can include bubbles and / or microbubbles to facilitate the echogenicity of the carrier (230) under ultrasound visualization.

[0059] The carrier (230) defines a generally cylindrical shape. As will be described in more detail below, the specific shape of the carrier (230) generally corresponds to the shape of the marker element (212). Therefore, in versions in which the shape of the marker element (212) changes, the shape of the carrier (230) may also change. In addition, the axial length of the carrier (230) may be greater than the axial length of the marker element (212), so that one or more portions of the carrier (230) may protrude from the marker element (212). In other versions, the axial length of the carrier (230) may be less than or equal to the axial length of the marker element (212).

[0060] The carrier (230) is positioned in the marker element (212) so that the marker element (212) wraps the outer surface of the carrier (230). Therefore, the carrier (230) is positioned relative to the marker element (212) to act as the core of the marker element (212). When the marker element (212) is in the pre-deployment configuration, the specific diameter of the carrier (230) can be approximately equal to the inner diameter of the marker element (212). In some versions, there may be a slight interference between the outer surface of the carrier (230) and the inner diameter of the marker element (212). It may be desirable to expect such interference to fix the marker element (212) to the carrier (230), which can improve ease of use by fixing the marker element (212) and the carrier (230) together as discrete units. In other versions, one or more parts of the marker element (212) may be embedded in the carrier (230) to further facilitate the marker element (212) to be additionally connected to the carrier (230).

[0061] FIG. 5A to FIG. 5B An exemplary use of the above-described marker (200) is shown for deploying the marker (200) into tissue. In this use, the marker (200) can be deployed at a biopsy site, although in other uses the marker (200) can also be deployed in a variety of tissue features. Prior to use, the marker (200) can be inserted into a marker delivery device similar to the above-described marker delivery device (150). Unlike the use of the above-described marker (100), a structure similar to the deployment balloon (180) may not be necessary. Therefore, the marker (200) can be directly inserted into a sleeve similar to the above-described sleeve (166). Then, a structure similar to the push rod (168) can be used to directly manipulate the marker (200) instead of the deployment balloon (180).

[0062] After being inserted into a marker delivery device similar to the marker delivery device (150), the marker delivery device can be manipulated to the appropriate position of the biopsy site. Placement at the biopsy site can be performed by inserting a structure similar to the sleeve (162) into a tissue tube or channel formed by a biopsy needle. Thus, insertion can occur after removing the biopsy needle and / or other components associated with the biopsy needle (such as, targeting sleeves, introducers, etc.). In other uses, devices such as the marker delivery device (150) can be used in combination with a biopsy needle, a targeting sleeve, an introducer, or other components. It may be desirable to use such additional components to maintain a tissue tube or channel for easy insertion. It may also be desirable to use such additional components to more easily identify the location of the biopsy site, thereby facilitating accurate placement of the marker (200) at the biopsy site.

[0063] Once a structure similar to cannula (162) of marker delivery device (150) is inserted into tissue, a plunger (170) or other actuation mechanism may be used to actuate push rod (168) or other similar structure. Marker (200) may then be maneuvered out of a structure similar to cannula (162) and into the biopsy site, into Figure 5A At this point, any suitable form of visualization technology (such as ultrasound, X-ray, MRI, etc.) can be used to confirm the position of marker (200).

[0064] Once the marker (200) is positioned as desired, the carrier (230) may swell or otherwise expand by absorbing fluid at the biopsy site. As the carrier (230) expands, the carrier (230) may drive the marker element (212) from Figure 5A The pre-deployment configuration shown in corresponds to the expansion to Figure 5B The post-deployment configuration shown in Figure 5B As best shown in , expansion to a post-deployment configuration may expand marker element (212) by deforming the shape formed by legs (216). Expansion may continue until one or more legs (216) and / or anchors (220) engage surrounding tissue, thereby retaining marker (200) at a desired location within the tissue.

[0065] Once the carrier (230) expands to manipulate the marker element (212) to the post-deployment configuration, the carrier (230) can begin to degrade and / or bioabsorb. Thus, the carrier (230) may disappear over time, leaving only the marker element (212) at the biopsy site. It should be understood that the particular material of the marker element (212) may be hard enough to maintain the post-deployment configuration even after the carrier (230) is absorbed, but flexible enough to allow the carrier (230) to manipulate the marker element (212). The marker element (212) can maintain this configuration over time, thereby maintaining the position of the marker (200) at the biopsy site for subsequent follow-up procedures.

[0066] III. Example Biopsy Site Marker with Self-Expanding Mesh

[0067] Figure 6An example of an alternative marker (300) similar to the marker (100) described above is shown. For example, as with the marker (100) described above, the marker (300) is typically configured to expand from a pre-deployment configuration to a post-deployment configuration, thereby anchoring or otherwise fixing the marker (300) at a predetermined location within the tissue. However, unlike the marker (100) described above, the present version of the marker (300) is typically self-expandable, such that an external structure such as a deployment balloon (180) may not be required to initiate the transition from the pre-deployment configuration to the post-deployment configuration. In some cases, it may be desirable that the self-expanding mechanism described herein allow the marker (300) to be used with a variety of deployment devices having or not having a structure similar to the deployment balloon (180). As will be described in more detail below, it may be desirable that the self-expanding mechanism described herein enhances the visualization of the marker (300) in certain circumstances.

[0068] As with the above-described marker (100), the present version of the marker (300) includes a marker element (312). Unless otherwise specified herein, the present version of the marker element (312) is substantially similar to the above-described marker element (112). For example, similar to the above, the marker element (312) can generally be configured to be radiopaque and / or echogenic to enhance visualization using one or more visualization modes.

[0069] As with the marker element (112) described above, the marker element (312) of this version includes a body (314) and a plurality of anchors (320) extending outwardly from one or more portions of the body (314). The body (314) is substantially similar to the body (114) described above. For example, the body (314) is generally configured to easily expand and contract between different positions, as will be described in more detail below. As with the body (114) described above, the body (314) of this version includes a plurality of interconnected legs (316) that can form a variety of repeating shapes and / or patterns.

[0070] As with the above-described legs (116), the legs (316) are generally configured to facilitate deformation of the marker element (312) between one or more different positions. Therefore, the specific shape formed by the legs (316) is generally configured to allow at least some movement of each leg (316). It may be desirable for each leg (316) to be flexed to a certain extent relative to the other legs (316) to allow for overall deformation of the marker element (312) and / or deformation of one or more portions of the marker element (312). It may also be desirable for the specific shape formed by the legs (316) to provide a relatively large coverage area and / or surface area for the marker element (312) using a relatively small volume of material. It may also be desirable for the specific shape formed by the legs (316) to provide an opening in the surface of the marker element (312) to facilitate tissue growth, thereby providing additional tissue anchoring and / or fixation over time.

[0071] As with the above-described legs (116), the legs (316) of this version are interconnected to form the general shape of the marker element (312). Similar to the above, the marker element (312) is formed in the shape of a hollow cylinder (e.g., a bracket-shaped, straight or tapered). Although both ends of the marker element (312) are open in this version, in other versions, one or both ends may be closed. In other versions, a variety of alternative shapes may be used. Suitable alternative shapes for the marker element (312) may include a truncated cone, a sphere, an egg shape, an annular shape, and the like.

[0072] The marker element (312) also includes a plurality of anchors (320) that are substantially similar to the anchors (120) described above. As with the anchors (120), the anchors (320) of this version extend outwardly from the body (314) and are generally configured to engage with tissue to increase the tendency of the marker element (312) to remain in a fixed position within the tissue. Each anchor (320) is formed as a generally straight wire segment extending from one or more legs (316). Although the anchors (320) of this version are generally straight, in other versions, the anchors (320) may be curved or various alternative shapes. Additionally, although not shown, in some versions, the anchors (320) may include barbs or other tissue engagement features to further facilitate engagement of the anchors (320) with tissue.

[0073] As with each anchor (120) described above, each anchor (320) of this version is generally angled relative to the longitudinal axis of the marker element (312). Similar to the above, the specific angle used for each anchor (320) may vary for all anchors (320) or for each anchor (320). Additionally, while the marker element (312) of this version includes four anchors (320), any other suitable number of anchors (320) may be used.

[0074] Unlike the above-described marker (100), the present version of the marker (300) includes a self-deformable material. Specifically, the marker element (312) includes a biocompatible material that is configured to transform the marker element (312) from a pre-deployment configuration to a post-deployment configuration after the marker (300) is deployed to the biopsy site. By way of example only, suitable self-deformable materials may include hydrogels, collagen, various combinations of hydrogels and collagen, and the like. Hydrogels and collagen may be desirable materials because the material properties involve swelling and / or expansion when exposed to moisture from the tissue. It may also be desirable that the hydrogels and collagen improve the echogenicity of the marker element (312).

[0075] Although the marker element (312) can be composed entirely of hydrogel and / or collagen, other materials can be used in combination with hydrogel and / or collagen in some versions. For example, in some versions, the marker element (312) can include a hydrogel and / or collagen outer coating, wherein a wire or polymer core is disposed within the coating. In such versions, the hydrogel and / or collagen coating can provide the above-mentioned self-expansion and echogenic properties. At the same time, the wire or polymer core can provide enhanced rigidity for the marker element (312). In addition, the hydrogel and / or collagen material is typically bioabsorbable. Therefore, after the hydrogel and / or collagen material is absorbed by the tissue, it may be desirable that the wire or polymer core provide a permanent structure for visualization of the marker (300).

[0076] Fig. 7A and Figure 7BAn exemplary use of the above-described marker (300) is shown for deploying the marker (300) into tissue. In this use, the marker (300) can be deployed at a biopsy site, although in other uses the marker (300) can also be deployed in a variety of tissue features. Prior to use, the marker (300) can be inserted into a marker delivery device similar to the marker delivery device (150) described above. Unlike the use of the above-described marker (100), a structure similar to the deployment balloon (180) may not be necessary. Therefore, the marker (300) can be directly inserted into a sleeve similar to the above-described sleeve (166). Then, a structure similar to the push rod (168) can be used to directly manipulate the marker (300) instead of the deployment balloon (180).

[0077] After being inserted into a marker delivery device similar to the marker delivery device (150), the marker delivery device can be manipulated to the appropriate position of the biopsy site. Placement at the biopsy site can be performed by inserting a structure similar to the sleeve (162) into a tissue tube or channel formed by a biopsy needle. Thus, insertion can occur after removing the biopsy needle and / or other components associated with the biopsy needle (such as, targeting sleeves, introducers, etc.). In other uses, devices such as the marker delivery device (150) can be used in combination with a biopsy needle, a targeting sleeve, an introducer, or other components. It may be desirable to use such additional components to maintain a tissue tube or channel for easy insertion. It may also be desirable to use such additional components to more easily identify the location of the biopsy site, thereby facilitating accurate placement of the marker (300) at the biopsy site.

[0078] Once a structure similar to cannula (162) of marker delivery device (150) is inserted into tissue, a plunger (170) or other actuation mechanism may be used to actuate push rod (168) or other similar structure. Marker (300) may then be maneuvered out of a structure similar to cannula (162) and into the biopsy site, into Fig. 7A At this point, any suitable form of visualization technology (such as ultrasound, X-ray, MRI, etc.) can be used to confirm the position of marker (300).

[0079] Once marker (300) is positioned as desired, the one or more materials forming marker element (312) may swell or otherwise expand by absorbing fluid at the biopsy site. As the materials forming marker element (312) expand, a corresponding expansion of marker element (312) may also occur. Specifically, marker element (312) may initially be in a Figure 6 and Fig. 7AIn the pre-deployment configuration, the hydrogel and / or collagen forming the marker element (312) may be in a dehydrated and / or compressed configuration. The dehydrated and / or compressed configuration may allow the marker element (312) to expand to Figure 7B As can be seen, expansion to the post-deployment configuration can expand marker element (312) by deforming the shape formed by legs (316). Expansion can continue until one or more legs (316) and / or anchors (320) engage surrounding tissue, thereby retaining marker (300) at a desired location within the tissue.

[0080] Once the material of the marker element (312) expands to manipulate the marker element (312) to the post-deployment configuration, such material may begin to degrade and / or absorb. As a result, at least some of the marker elements (312) may disappear over time, with only the non-bioabsorbable portion of the marker element (312) remaining at the biopsy site. It should be understood that a particular non-bioabsorbable material portion of the marker element (312) may be sufficiently rigid to maintain the post-deployment configuration even after the non-bioabsorbable portion is absorbed; yet flexible enough to allow the non-bioabsorbable portion to manipulate the marker element (312). The marker element (312) can maintain this configuration over time, thereby maintaining the position of the marker (300) at the biopsy site for subsequent follow-up procedures.

[0081] IV. Exemplary Combinations

[0082] 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 examples 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 mentioned below, it shall not be presumed that these additional features are added for any reason related to patentability.

[0083] Example 1

[0084] A biopsy site marker comprises: a carrier configured to expand in diameter in response to moisture; and a marker element comprising a base defining a plurality of interconnected legs, each leg configured to move relative to another leg to allow the marker element to move from a pre-deployment configuration to a post-deployment configuration, the base being disposed around an outer surface of the carrier, the carrier being configured to drive the marker element to move from the pre-deployment configuration to the post-deployment configuration.

[0085] Example 2

[0086] In the marker of Example 1, the outer surface of the carrier defines a first diameter, the base defines a second diameter, and the first diameter corresponds to the second diameter.

[0087] Example 3

[0088] In the marker of Example 1, the outer surface of the carrier defines a first diameter and the base defines a second diameter, the second diameter being smaller than the first diameter to provide an interference fit between the carrier and the base.

[0089] Example 4

[0090] As a marker as described in any of Examples 2 and 3, the carrier is configured to expand the second diameter defined by the base when the marker element is driven to move from the pre-deployment configuration to the post-deployment position.

[0091] Example 5

[0092] As a marker as described in any of Examples 2 and 3, the carrier is configured to expand the second diameter defined by the base by three times or more when the marker element is driven to move from the pre-deployment configuration to the post-deployment position.

[0093] Example 6

[0094] As a marker as described in any of Examples 1 to 5, the marker element includes a material having at least a certain rigidity so that the base is configured to maintain a predetermined shape in the absence of the carrier.

[0095] Example 7

[0096] A marker as described in any one of Examples 1 to 6, wherein the carrier is bioabsorbable and the marker element is not bioabsorbable.

[0097] Example 8

[0098] As a marker as described in any of Examples 1 to 7, the carrier is configured to deform the shape defined by the plurality of legs during expansion of the carrier.

[0099] Example 9

[0100] As a marker as described in any one of Examples 1 to 8, the carrier defines a cylindrical shape, and the main body portion of the marker element defines a shape corresponding to the carrier.

[0101] Example 10

[0102] In the marker of any one or more of Examples 1 to 9, the carrier defines a first axial length, the main body portion of the marker element defines a second axial length, and the first axial length is longer than the second axial length.

[0103] Example 11

[0104] As a marker as described in any of Examples 1 to 10, the base also includes one or more anchors, each of the one or more anchors extending outwardly from one or more legs of the plurality of legs.

[0105] Example 12

[0106] In a marker as described in any of Examples 1 to 10, the base also includes one or more anchors, each of the one or more anchors extending outward from one or more of the plurality of legs, and each of the one or more anchors is oriented at a certain angle relative to a longitudinal axis defined by the base.

[0107] Example 13

[0108] As a marker as described in any of Examples 1 to 12, the marker element includes a surface treatment on one or more outer surfaces of the marker element, and the surface treatment is configured to improve the echogenicity of the marker element.

[0109] Example 14

[0110] A marker as described in any one of Examples 1 to 13, wherein the carrier comprises a collagen material.

[0111] Example 15

[0112] As a marker as described in any of Examples 1 to 14, the carrier includes a hydrogel material.

[0113] Example 16

[0114] A biopsy site marker comprises: a marker element, the marker element including a base and an anchor portion, the anchor portion extending from the base, the base defining a plurality of interconnected legs, each leg being configured to move relative to another leg to transition the marker element from a pre-deployment configuration to a post-deployment configuration, the anchor being configured to engage tissue when the marker element is in the post-deployment configuration.

[0115] Example 17

[0116] In the biopsy site marker of Example 16, the plurality of interconnected legs together define a mesh structure.

[0117] Example 18

[0118] As a biopsy site marker as described in any of Examples 16 or 17, the plurality of interconnected legs together define a plurality of diamond-shaped openings extending through the base.

[0119] Example 19

[0120] As a biopsy site marker as described in any of Examples 16 to 18, the marker element defines a hollow interior that is configured to receive a deployment balloon.

[0121] Example 20

[0122] As a biopsy site marker as described in any of Examples 16 to 19, the marker element includes a self-deformable material, and the self-deformable material is configured to transform the marker element from the pre-deployment configuration to the post-deployment configuration after contact with tissue at the biopsy site.

[0123] Example 21

[0124] As a biopsy site marker as described in any of Examples 16 to 19, the marker element includes a self-deformable material, which is configured to transform the marker element from the pre-deployment configuration to the post-deployment configuration after contact with tissue at the biopsy site, and the self-deformable material defines each leg of the plurality of interconnected legs.

[0125] Example 22

[0126] A biopsy site marker as described in any of Examples 16 to 21, further comprising a carrier coupled to a portion of the marker element, the carrier being bioabsorbable.

[0127] Example 23

[0128] A biopsy site marker as described in any of Examples 16 to 21, further comprising a carrier coupled to a portion of the marker element, the carrier being bioabsorbable, the main body portion of the marker element encapsulating a portion of the carrier.

[0129] Example 24

[0130] The biopsy site marker as described in any of Examples 16 to 21 further includes a carrier connected to a portion of the marker element, the carrier is bioabsorbable, and a portion of the marker element is embedded in a portion of the carrier.

[0131] Example 25

[0132] A method for securing a biopsy site marker at a biopsy site, the method comprising: inserting a marker delivery device into tissue to position a deployment opening of a cannula at the biopsy site; actuating a push rod to extend a delivery balloon from the deployment opening of the cannula into the biopsy site, the delivery balloon having a marker element disposed on a portion thereof; expanding the delivery balloon to deform the marker element; and removing the delivery balloon from the biopsy site while the marker element remains in place at the biopsy site.

[0133] Example 26

[0134] As described in Example 25, the step of expanding the delivery balloon includes inflating the delivery balloon.

[0135] Example 27

[0136] As in the method of any of Examples 25 or 26, the step of expanding the delivery balloon includes expanding the delivery balloon to deform the marker element until the marker element contacts at least some tissue of the biopsy site.

[0137] Example 28

[0138] As described in any of the methods of Examples 25 to 27, the act of deforming the marker element includes moving a plurality of interconnected legs relative to each other to increase the volume of space occupied by the marker element without increasing the volume of material defined by the marker element.

[0139] Example 29

[0140] As in the method of any of Examples 25 to 28, the step of expanding the delivery balloon includes moving one or more anchors extending from a portion of the marker element into engagement with at least some tissue of the biopsy site.

[0141] Example 30

[0142] A biopsy marking system, the system comprising: a biopsy site marker as described in any one or more of Examples 1 to 24; a marker delivery device, the marker delivery device comprising an introduction sleeve, a handle and a push rod, 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.

[0143] Example 31

[0144] In the biopsy marking system of Example 30, the marker delivery device further includes a deployment balloon configured to receive a portion of the biopsy site marker.

[0145] V. Conclusion

[0146] 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.

[0147] 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 skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above 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 structures and operations shown and described in the specification and drawings.

Claims

1. A biopsy site marker, comprising: a carrier configured to expand in diameter in response to humidity; as well as a marker element, the marker element comprising a base, The base defines a plurality of interconnected legs, each leg being configured to move relative to another leg to allow the marker element to move from a pre-deployment configuration to a post-deployment configuration, The base is disposed around an outer surface of the carrier, and the carrier is configured to drive the marker element to move from the pre-deployment configuration to the post-deployment configuration.

2. The marker of claim 1, wherein the outer surface of the carrier defines a first diameter and the base defines a second diameter, the first diameter corresponding to the second diameter.

3. The marker of claim 1, wherein the outer surface of the carrier defines a first diameter and the base defines a second diameter, the second diameter being smaller than the first diameter to provide an interference fit between the carrier and the base.

4. The marker of any one of claims 2 and 3, wherein the carrier is configured to expand the second diameter defined by the base when the marker element is driven to move from the pre-deployment configuration to the post-deployment position.

5. The marker of any one of claims 2 and 3, wherein the carrier is configured to expand the second diameter defined by the base by three times or more when the marker element is driven to move from the pre-deployment configuration to the post-deployment position.

6. The marker of any one of claims 1 to 5, the marker element comprising a material having at least a certain rigidity such that the base is configured to maintain a predetermined shape in the absence of the carrier.

7. The marker of any one of claims 1 to 6, wherein the carrier is bioabsorbable and the marker element is not bioabsorbable.

8. The marker of any one of claims 1 to 7, the carrier being configured to deform a shape defined by the plurality of legs during expansion of the carrier.

9. The marker of any one of claims 1 to 8, wherein the carrier defines a cylindrical shape, and the main body portion of the marker element defines a shape corresponding to the carrier.

10. The marker of any one or more of claims 1 to 9, wherein the carrier defines a first axial length and the main body portion of the marker element defines a second axial length, the first axial length being longer than the second axial length.

11. The marker of any one of claims 1 to 10, the base further comprising one or more anchors, each of the one or more anchors extending outwardly from one or more of the plurality of legs.

12. The marker of any one of claims 1 to 10, wherein the base further comprises one or more anchors, each of the one or more anchors extending outwardly from one or more of the plurality of legs, each of the one or more anchors being oriented at an angle relative to a longitudinal axis defined by the base.

13. The marker of any one 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 any one of claims 1 to 13, wherein the carrier comprises a collagen material.

15. The marker of any one of claims 1 to 14, wherein the carrier comprises a hydrogel material.

16. A biopsy site marker, comprising: a marker element comprising a base portion and an anchor portion, The anchor portion extends from the base, The base defines a plurality of interconnected legs, each leg being configured to move relative to another leg to transition the marker element from a pre-deployment configuration to a post-deployment configuration, The anchor is configured to engage tissue when the marker element is in the post-deployment configuration.

17. The biopsy site marker of claim 16, the plurality of interconnected legs together defining a mesh structure.

18. The biopsy site marker of any one of claims 16 or 17, the plurality of interconnected legs together defining a plurality of diamond-shaped openings extending through the base.

19. The biopsy site marker of any one of claims 16 to 18, the marker element defining a hollow interior configured to receive a deployment balloon.

20. The biopsy site marker of any one of claims 16 to 19, the marker element comprising a self-deformable material configured to transform the marker element from the pre-deployment configuration to the post-deployment configuration upon contact with tissue at a biopsy site.

21. A biopsy site marker as described in any one of claims 16 to 19, wherein the marker element includes a self-deformable material, and the self-deformable material is configured to transform the marker element from the pre-deployment configuration to the post-deployment configuration after contact with tissue at the biopsy site, and the self-deformable material defines each leg of the plurality of interconnected legs.

22. The biopsy site marker of any one of claims 16 to 21 further comprising a carrier coupled to a portion of the marker element, the carrier being bioabsorbable.

23. The biopsy site marker of any one of claims 16 to 21 further comprising a carrier coupled to a portion of the marker element, the carrier being bioabsorbable, the body portion of the marker element encapsulating a portion of the carrier.

24. The biopsy site marker of any one of claims 16 to 21 further comprising a carrier coupled to a portion of the marker element, the carrier being bioabsorbable, a portion of the marker element being embedded within a portion of the carrier.

25. A method for fixing a biopsy site marker at a biopsy site, the method comprising: (a) inserting a marker delivery device into tissue to position a deployment opening of the cannula at a biopsy site; (b) actuating a push rod to extend a delivery balloon from the deployment opening of the cannula into the biopsy site, the delivery balloon having a marker element disposed on a portion thereof; (c) expanding the delivery balloon to deform the marker element; as well as (d) Removing the delivery balloon from the biopsy site while the marker element remains in place at the biopsy site.

26. The method of claim 25, the step of expanding the delivery balloon comprising inflating the delivery balloon.

27. The method of any one of claims 25 or 26, the step of expanding the delivery balloon comprising expanding the delivery balloon to deform the marker element until the marker element contacts at least some tissue of the biopsy site.

28. The method of any one of claims 25 to 27, wherein the act of deforming the marker element comprises moving a plurality of interconnected legs relative to one another to increase the volume of space occupied by the marker element without increasing the volume of material defined by the marker element.

29. The method of any one of claims 25 to 28, the step of expanding the delivery balloon comprising moving one or more anchors extending from a portion of the marker element into engagement with at least some tissue of the biopsy site.

30. A biopsy marking system, the system comprising: (a) A biopsy site marker as claimed in any one or more of claims 1 to 24; (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.

31. The biopsy marking system of claim 30, the marker delivery device further comprising a deployment balloon configured to receive a portion of the biopsy site marker.

Images