Lesion bracketing solution

Abstract

A method for bracketing a margin of a lesion includes deploying a first biopsy site marker, deploying a second biopsy site marker, and using a tether. The step of deploying the first biopsy site marker includes deploying from a cannula proximate a first side of the margin of the lesion. The step of deploying the second biopsy site marker includes deploying from the cannula proximate a second side of the margin of the lesion with the first biopsy site marker being connected to the second biopsy site marker by the tether. The step of using the tether includes using the tether to locate the first side and the second side of the margin of the lesion.

Description

LESION BRACKETING SOLUTIONPRIORITY

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 680,877, entitled “Lesion Bracketing Solution,” filed on August 8, 2024, the disclosure of which is incorporated by reference herein.BACKGROUND

[0002] A number of patients will have breast biopsies because of irregular mammograms and palpable abnormalities. Biopsies can include surgical excisional biopsies and stereotactic and ultrasound guided needle breast biopsies. In the case of image directed biopsy, the radiologist or other physician may take a small sample of tissue for laboratory analysis. If the biopsy proves to be malignant, additional surgery (e.g., a lumpectomy or a mastectomy) may be required. In the case of needle biopsies, the patient may return to the radiologist a day or more later, and the biopsy site (the site of the lesion) may need to be relocated in preparation for the surgery. An imaging system, such as ultrasound, magnetic resonance imaging (MRI) or x-ray may be used to locate the biopsy site. In order to assist the relocation of the biopsy site, a marker may be placed at the time of the biopsy.

[0003] The use of markers after breast biopsies to mark the location where the biopsied tissue was removed is described in the following US Patents: US 6,083,524, “Polymerizable biodegradable polymers including carbonate or dioxanone linkages,” issued July 4, 2000; US 6,162,241, “Hemostatic tissue sealants,” issued December 4, 2000; US 6,270,464, “Biopsy localization method and device,” issued August 7, 2001; US 6,356,782, “Subcutaneous cavity marking device and method,” issued March 12, 2002; US 6,605,294, “Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels,” issued August 12, 2003; US 8,600,481, “Subcutaneous cavity marking device,” issued December 3, 2013 and US 8,939,910, “Method for enhancing ultrasound visibility of hyperechoic materials”,issued January 27, 2015. All of these US Patents are incorporated by reference in their entirety.

[0004] In some circumstances, a marker can be positioned within a patient to identify the location of a suspicious lesion. Such location methods may be useful in subsequent procedures to relocate the suspicious lesion. However, a challenge with such markers may be the markers only provide limited location information. For instance, such markers may only indicate one spot corresponding to the suspicious lesion. Therefore, it may be desirable for markers to include one or more features to provide additional information related to the location of a suspicious lesion.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements.

[0006] FIG. 1 depicts a perspective view of an illustrative lesion bracketing assembly;

[0007] FIG. 2 depicts a perspective view of a biopsy site marker of the lesion bracketing assembly of FIG. 1, the biopsy site marker being in a pre-depl oyment configuration;

[0008] FIG. 3 depicts another perspective view of the biopsy site marker of FIG. 2, the biopsy site marker being in a post-deployment configuration;

[0009] FIG. 4 depicts a perspective view of an illustrative marker delivery device for use in deploying the lesion bracketing assembly of FIG. 1;

[0010] FIG. 5 depicts a side cross-sectional view of a cannula of the marker delivery device of FIG. 4, the cross-section taken along line 5-5 of FIG. 4;FIG. 6A depicts a perspective view of the marker delivery device of FIG. 4 being used to deploy the lesion bracketing assembly of FIG. 1 at a biopsy site, the marker delivery device deploying a first portion of the lesion bracketing assembly; andFIG. 6B depicts another perspective view of the marker delivery device of FIG. 4 being used to deploy the lesion bracketing assembly of FIG. 1 at a biopsy site, the marker delivery device deploying a second portion of the lesion bracketing assembly.

[0011] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0012] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0013] It may be beneficial to be able to mark the location or margins of a lesion, whether temporarily or permanently, prior to or immediately after removing or sampling it. Marking prior to removal may help to ensure that the entire lesion is excised, if desired. Alternatively, if the lesion were inadvertently removed in its entirety, marking the biopsy site immediately after the procedure would enable reestablishment of its location for future identification. Once a marker is positioned ina biopsy site, it may be desirable for the marker to remain visible. For instance, it may be desirable for one or more portions of the marker to be visible under various modes of visualization such as x-ray, ultrasound, magnetic resonance imaging (MR1), and / or etc.

[0014] I. Illustrative Lesion Bracketing Assembly

[0015] FIG. 1 shows an illustrative lesion bracketing assembly (100) that is generally configured for deployment in tissue to mark the location of a biopsy site. As will be described in greater detail below, one or more portions of lesion bracketing assembly (100) are further configured to mark one or more boundaries of the biopsy site, in addition to the particular location of the biopsy site within tissue. As will be appreciated, such boundary marking capabilities may be desirable to permit identification of margins of a suspicious lesion.

[0016] Lesion bracketing assembly (100) of the present example includes a first biopsy site marker (110), a second biopsy site marker (140), and a tether (180) extending between first marker (110) and second marker (140). In the present example, first marker (110) and second marker (140) are substantially similar in construction. In other examples, first marker (110) and second marker (140) may have one or more differing characteristics. Generally, both first marker (110) and second marker (140) are configured to expand from a pre-deployment configuration to a post-deployment configuration to thereby anchor each respective marker (110, 140) within tissue.

[0017] Each marker (110, 140) of the present example is generally configured as a selfexpanding marker with one or more elements that expand within tissue to anchor each marker (110, 140) at a specific point within the tissue. As described in greater detail below, in some examples, such self-expanding characteristics may be achieved by shape-memory alloys, resilient materials (e.g., such as a self-expanding nitinol marker structure). Each marker (110, 140) includes a marker element (112, 142), which is generally configured to enhance visualization of each marker (110, 140) within tissue. Thus, each marker element (112, 142) can be generally configured as non-bioabsorbable and radiopaque and / or echogenic to enhance visualization over time. Additionally, although not shown, it should be understood that in some versions, one or both of markers (110, 140) may include certain bioabsorbable structures, which may be referred to as a “carrier” in some circumstances. In such examples, such carriers may surround each marker element (112, 142) and be configured to expand in the presence of moisture. In such examples, a material such as hydrogel and / or collagen may expand to fill a tissue cavity, thereby facilitating anchoring of each marker (110, 140) within tissue. Additionally, due to the absorption of fluid, visualization of each marker (110, 140) may be enhanced, particularly under ultrasound visualization. In other examples, such carriers may alternatively configured as a coating. In still other versions, each marker (110, 140) may only include a respective marker element (112, 142), omitting structures such as a carrier. In other words, in some versions, one or both of markers (110, 140) may be configured as a “bare” marker.

[0018] Each marker (110, 140) of the present version is configured to transition from a predeployment configuration (see, e g., FIG. 2) to a post-deployment (see, e.g., FIG. 3) configuration after being deployed at a biopsy site. Although certain specific examples are provided herein of structures that can facilitate transition from the predeployment configuration to the post-deployment configuration, it should be understood such structures are for illustration purposes only and should be considered optional unless otherwise stated herein. In other examples, various alternative markers may be used in addition to, or in lieu of, the markers (110, 140) described herein. While such alternative markers may still be configured to transition from a pre-deployment configuration to a post-deployment configuration, the predeployment and post-deployment configurations may be varied. Additionally, the structures and / or materials used to facilitate such a transition may likewise be varied.

[0019] In the present example, each marker (110, 140) includes a base portion (120, 150) and an anchor portion (130, 160), with both base portion (120, 150) and anchor portion (130, 160) being defined by a respective marker element (112, 142). Each baseportion (120, 150) defines a generally cylindrical shape. In the present example, each base portion (120, 150) is hollow and defines an open end (122, 152) on each proximal and distal side of base portion (120, 150). In other versions, one or more of base portions (120, 150) may be partially or substantially solid.

[0020] Each marker (110, 140) includes an anchor portion (130, 160) extending proximally and distally relative to each base portion (120, 150). In other words, each marker (110, 140) includes two anchor portions (130, 160), with each anchor portion (130, 160) extending in opposing directions relative to a respective base portion (120, 150). Although the present example defines a generally symmetrical configuration with respect to anchor portions (130, 160), it should be understood that in other examples, asymmetrical configurations may be used by either varying configurations for anchor portions (130, 160) or omitting one anchor portion (130, 160) entirely.

[0021] Although reference to “anchor” in anchor portion (130, 160) herein may suggest that only anchor portion (103, 160) may serve to anchor marker (110, 140) within tissue, it should be understood that other features of marker (110, 140) may also be used to facilitate anchoring in tissue. Such anchoring functionality may be present even if a feature is not referred to herein directly using the term “anchor” or similar terms. For instance, under some circumstances, one or more portions of base portion (120, 150) may also have an anchoring function by facilitating the growth of tissue into marker (110, 140). In addition, or in the alternative, some versions of marker (110, 140) may include structures similar to a carrier described above, which may expand within tissue and serve to further facilitate anchoring of marker (110, 140) within tissue.

[0022] Each anchor portion (130, 160) includes a plurality of active arms (132, 162) (also referred to as movable arms, engagement arms, or anchor arms) and a plurality of inactive arms (134, 164) (also referred to as passive arms, stationary arms, or straight arms). Both active arms (132, 162) and inactive arms (134, 164) are arranged in a circular pattern with respect to base portion, such that each marker (110, 140) may define a generally cylindrical shape when in the pre-deployment configuration as shown in FIGS. 1 and 2. Meanwhile, inactive arms (132, 162) may be configured tomove relative to inactive arms (134, 162), as described in greater detail below, to define an irregular shape corresponding to the post-deployment configuration as shown in FIG. 3. Although each anchor portion (130, 160) of the present example includes an identical number of active arms (132, 162) and inactive arms (134, 164) (e.g., three and three, respectively), it should be understood that in other examples a different number of active arms (132, 162) and inactive arms (134, 164) may be used.

[0023] Both active arms (132, 162) and inactive arms (134, 164) define a strip-shaped configuration. Optionally, an interior and exterior of each of active arms (132, 162) and inactive arms (134, 164) may include a curved surface to complement the cylindrical shape of a respective base portion (120, 150). In some examples, the outermost end of each active arm (132, 162) and / or inactive arm (134, 164) may define a blunt, curved or atraumatic shape, although such a configuration as optional and the outermost end of each active arm (132, 162) and / or inactive arm (134, 164) may be generally flat in some examples. Similarly, in the present example, active arms (132, 162) are optionally shorter than inactive arms (134, 164). Although in other examples, active arms (132, 162) may define a length longer or the same relative to inactive arms (134, 164).

[0024] As described above, active arms (132, 162) may move between a pre-deployment configuration and a post-deployment configuration. Meanwhile, inactive arms (134, 164) may remain generally stationary during the transition of active arms (132, 162) from the pre-deployment configuration to the posit deployment configuration. FIG. 3 shows active arms (132, 162) in the post-deployment state. In this state, each active arm (132, 162) curves outwardly from a longitudinal axis defined by marker element (112, 142). In other words, active arms (132, 162) may be splayed outwardly relative to each other. Also in this state, inactive arms (134, 164) remain in a generally straight configuration, extending along the longitudinal axis defined by marker element (112, 142). In some versions, the outward extension, curvature, and / or splaying of active arms (132, 162) may approximately double the diameter of marker (110, 140) relative to the diameter when in the pre-deployment configuration. In otherversions, this outward extension, curvature, and / or splaying of active arms (132, 162) may approximately triple the diameter of marker (110, 140) relative to the diameter when in the pre-deployment configuration.

[0025] Active arms (132, 162) of the present version are integral with each respective base portion (120, 150). Marker element (112, 142) is thus a single monolithic, homogeneous continuum of material. Although, as will be described in greater detail below, such integral construction is merely optional. The particular material used in the present version is a shape-memory alloy. As will be described in greater detail below, the shape-memory characteristic of the material used in marker element (112, 142) may be used to permit transitioning of active arms (132, 162) from the predeployment configuration to the post-deployment configuration using patient heat from tissue surrounding the biopsy site to initiate the transition.

[0026] It should be understood that a variety of suitable shape-memory alloys may be used for marker element (112, 142). In addition, the constituents of any one shape-memory alloy may be varied to produce desired properties (e g., transformation temperature). One suitable shape-memory alloy may include Nitinol (nickel-titanium). Any suitable grade of Nitinol may be used. By way of example only, one suitable grade of Nitinol may include Nitinol S (ASTM 2063). Alternatively, other shape-memory alloys may include copper-based alloys, gold-cadmium, silver-cadmium, and / or nickelaluminum.

[0027] In the present example, shape-memory alloys may be used to drive transition of each marker (110, 140) from the pre-deployment configuration to the post-deployment configuration. In particular, each active arm (132, 162) may be configured with a predetermined post-deployment shape in accordance with the description above. This post-deployment shape may be imputed into the shape-memory alloy by one or more heat treatments. Prior to use, active arms (132, 162) may be bent to the generally straight pre-deployment shape. Once deployed, each marker (110, 140) may absorb heat from tissue, thereby triggering the shape-memory alloy to return each active arm (132, 162) to the post-deployment shape.

[0028] As described above, in some examples, shape-memory alloys may be omitted from one or more of markers (110, 140). In such examples, transition of each marker (110, 140) may be driven by other mechanisms. By way of example only, in such examples, each active arm (132, 162) may include a malleable or resilient material such that each active arm (132, 162) may be pre-bent to the post-deployment shape described above. Prior to use, each active arm (132, 162) may be temporarily straightened using one or more structures applying external forces to each active arm (132, 162). As will be described in greater detail below, one such structures may be a cannula used in a marker delivery device. Regardless, once such external forces are released, active arms (132, 162) may return to the pre-bent, post-deployment shape.

[0029] As described above, markers (110, 140) are connected to each other by tether (180). In other words, tether (180) extends from first biopsy site marker (110) to second biopsy site marker (140). As will be understood, tether (180) is generally configured for localization purposes with respect to markers (110, 140). Such localization may include external visualization using one or more imaging modalities such as ultrasound imaging and / or x-ray imaging. In addition, or in the alternative, such localization may include non-visualization modalities such as magnetic detection or radio frequency localization. Such localization may additionally include guidance during resection procedures. With such guidance, tether (180) may be used to trace a path from one marker (110, 140) to another (140, 110), as will be described in greater detail below.

[0030] Tether (180) is generally an elongate, thin, and flexible material such as a suture, string, or wire. Flexibility is generally desirable to promote movement of each marker (110, 140) relative to each other marker (110, 140), such as during deployment of each marker (110, 140). Flexibility is also generally desirable to promote ease of manipulation of tether (180) itself, such as during a resection procedure when tether (180) is used as a guide.

[0031] Tether (180) may include a variety of materials in braded or wire form. Suitable materials may include for example, metals such as biocompatible stainless steel,synthetic polymer fibers such as polypropylene, natural materials such as silk, and / or etc. When tether (180) includes a suture material (e.g., synthetic polymer), such suture material may be either dissolvable or non-absorbable.

[0032] An opposing end of tether (180) is secured to at least a portion of each marker (110, 140). In other words, each marker (110, 140) is connected to the other marker (110, 140) using tether (180) with tether (180) extending between each marker (110, 140). Tether (180) may be coupled to each marker (110, 140) at one or more points on each marker (110, 140). In one example, tether (180) may be coupled to base portion (120, 150). In another example, tether (180) may be coupled to anchor portion (130, 160). In still other examples, tether (180) may be coupled to any other suitable portion of each marker (110, 140) as will be appreciated by those of ordinary skill in the art in view of the teachings herein.

[0033] Although markers (110, 140) are shown and described herein as having a particular configuration, it should be understood that in other examples, one or more of markers (110, 140) may be substituted with various alternative marker configurations coupled together by tether (180). In some examples, such alternative markers may be constructed in accordance with at least some of the teachings of U.S. Pat. No. 10,492,884, entitled “Biopsy Marker,” issued on December 3, 2019; U.S. Pat. No. 11,759,285, entitled “Biopsy Marker with Anchoring Capabilities,” issued on September 9, 2023; U.S. Pub. No. 2023 / 0000587, entitled “Non-Migrating Biopsy Site Identifiers,” published on January 5, 2023; U.S. Pub. No. 2024 / 0058093, entitled “Biopsy Site Marker having Movable Portions,” published on February 22, 2024; and International App. No. WO 2023215090, entitled “Biopsy Site Marker with Increased Visualization and Non-Migration Features,” published on November 9, 2023, the disclosures of which are hereby incorporated by reference herein.

[0034] FIG. 4 shows an illustrative marker delivery device (250) that may be used in connection with lesion bracketing assembly (100) described above for deployment of lesion bracketing assembly (100) within tissue. Although a single marker delivery device (250) is shown herein for deploying both markers (110, 140) of lesionbracketing assembly (100), it should be understood that in other examples, multiple marker delivery devices (250) may be used with one marker delivery device (250) configured to deploy each marker (110, 140) independently of the other marker delivery device (250). Marker delivery device (250) includes an elongate outer cannula (262) having a marker exit, such as distal opening (264) formed in the distal end of the cannula (262).

[0035] A grip (266) can be provided at the proximal end of cannula (262). A push rod (268) can be provided, with push rod (268) extending coaxially in outer cannula (262) such that push rod (268) is configured to translate within outer cannula (262) to displace one or more markers (110, 140) through distal opening (264). Push rod (268) may have sufficient rigidity in compression to push a marker from an internal lumen (265) of outer cannula (262) out through distal opening (264), yet be relatively flexible in bending. A plunger (270) is coupled at the proximal end of rod (268) for forcing push rod (268) distally in outer cannula (262) to deploy a marker (110, 140) out of outer cannula (262).

[0036] As will be described in greater detail below, an operator may grasp grip (266) with two fingers, and may push on plunger (270) using the thumb on the same hand, so that marker delivery device (250) is operated by a user's single hand. A spring (not shown) or other feature may be provided about rod (268) to bias rod (268) proximally relative to grip (266) and outer cannula (262).

[0037] Outer cannula (262) may be formed of any suitable metallic or non-metallic material. For instance, in some examples, outer cannula (262) is formed of a rigid biocompatible metal such as stainless steel. In such examples, rigidity may be desirable to faciliate tissue penetration for deployment of markers (110, 140) in tissue, as will be described in greater detail below. In other examples, outer cannula (262) 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 is known under the tradename PEBAX. Insuch examples, outer cannula (262) may be formed of PEBAX, and may be substantially transparent to visible light and X-ray.

[0038] Outer cannula (262) is configured to receive lesion bracketing assembly (100) within internal lumen (265) defined by outer cannula (262). In particular, outer cannula (262) is sized of a sufficient diameter and length to receive both first biopsy site marker (110) and second biopsy site marker (140). As described above, although outer cannula (262) of the present example is configured to receive all of lesion bracketing assembly (100), in other examples, outer cannula (262) may be configured to receive only a portion of lesion bracketing assembly (100) such as a single marker (110, 140). In such examples, another marker delivery device (250) may be used to receive the other marker (110, 140) within a similar outer cannula (262), while tether (180) may extend between both marker delivery devices (250).

[0039] As described above, distal opening (264) is oriented on the distal end of outer cannula (262). Distal opening (262) is defined by a sharpened tip (263) in the distal end of outer cannula (262). Sharpened tip (263) is defined by an angled cut in outer cannula (262). Such a sharpened tip (263) may be desirable in some examples to promote use of outer cannula (262) for penetrating tissue. As will be described in greater detail below, such tissue penetration may be desirable in certain circumstances to permit deployment of lesion bracketing assembly (100) into tissue. In other examples, sharpened tip (263) may be omitted and distal opening (262) may be formed by a relatively flat distal end in outer cannula (262).

[0040] II. Illustrative Use of Lesion Bracketing Assembly

[0041] FIGS. 5 through 6B show an illustrative use of legion bracketing assembly (100) for localizing the margins of a lesion during a procedure. As best seen in FIG. 5, lesion bracketing assembly (100) may be initially loaded into marker deliver device (250). In particular, lesion bracketing assembly (100) may be loaded within outer cannula (262) of marker delivery device (250) proximate distal opening (264) with markers (110, 140) in an end-to-end configuration and tether (180) disposed therebetween.Although not shown, it should be understood that in some uses, tether (180) may additionally be coiled or otherwise stowed in this configuration to save space and generally avoid tangling or snagging of tether (180). Although not shown, it should be understood that in some examples, outer cannula (262) may optionally include one or more features proximate distal opening (264) to prevent inadvertent deployment of markers (1 10, 140) through distal opening (264) at this stage. Suitable features may include, for example, detents, ribs, clips, and / or etc.

[0042] The initial configuration of marker delivery device (250) and lesion bracketing assembly (100) may correspond to a stage of use prior to a procedure to bracket a margin of a lesion. It should be understood that prior to this stage, marker delivery device (250) and / or lesion bracketing assembly (100) may be subjected to other preprocedure steps or operations. For instance, in some uses, marker delivery device (250) may be pre-loaded with lesion bracketing assembly (100) and the combination may be positioned within sterile packaging. The sterile packaging and contents therein may be subjected to one or more sterilization processes to sterilize both marker delivery device (250) and lesion bracketing assembly (100). The combination of marker delivery device (250) and lesion bracketing assembly (100) may then be removed from the sterile packing prior to beginning the procedure to bracket a margin of a lesion. Additionally, such a margin bracketing procedure may occur in combination with other clinical procedures such as a biopsy procedure to acquire a biopsy sample from the lesion being bracketed.

[0043] To begin the margin bracketing procedure, outer cannula (262) of marker delivery device (250) may be inserted into tissue as shown in FIG. 6A. Such insertion may be performed under a form of imaging guidance such as ultrasound guidance, x-ray guidance, and / or etc. Under such guidance, sharpened tip (263) may be positioned proximate a margin of a lesion (L). Optionally, the sharp configuration of sharpened tip (263) may aid in penetrating tissue to position sharpened tip (262) proximate the margin of lesion (L).

[0044] Once sharpened tip (263) is positioned relative to lesion (L) as desired, first biopsy site marker (110) can be deployed. In particular, an operator can press plunger (270) of marker delivery device (250) to translate push rod (268) distally within outer cannula (262). Push rod (268) then drives lesion bracketing assembly (100) distally to eject first biopsy site marker (110) from distal opening (264) in sharpened tip (263).

[0045] Once first biopsy site marker (110) is deployed, one or more portions of first biopsy site marker (110) may optionally self-expand to secure first biopsy site marker (110) in a desired position proximate the margin of lesion (L). As described above, in the present example, first biopsy site marker (110) includes a shape-memory alloy. Thus, in one use, first biopsy site marker (110) may absorb heat from surrounding tissue, which may transition first biopsy site marker (110) from the pre-deployment configuration to the post-deployment configuration described above. In other uses, various alternative self-expansion actions may occur at this stage via heat from surrounding tissue or other suitable mechanisms such as moisture, the release of a retaining force applied by outer cannula (262), or the release of a retaining force applied by other external components. Regardless of the mechanism, it should be understood that in uses with self-expansion actions, relatively quick mechanisms of self-expansion are generally desirable over relatively slow mechanisms of selfexpansion (e.g., seconds or minutes versus hours).

[0046] After first biopsy site marker (110) is deployed as described above, second biopsy site marker (140) may be deployed. As best seen in FIG. 6B, marker delivery device (250) may next be used to position sharpened tip (263) proximate the margin of lesion (L). This positioning may be on a side of lesion (L) opposite of the side where first biopsy site marker (110) was positioned. Such an opposing positioning may be desirable to permit the combination of first biopsy site marker (110) and second biopsy site marker (140) to define width, length, height, or other extent of lesion (L). As similarly described above, guidance of outer cannula (262) at this stage may be performed using a form of imaging guidance such as ultrasound guidance, x-ray guidance, and / or etc.

[0047] At this stage, positioning of sharpened tip (262) may also include using sharpened tip (262) and / or outer cannula (262) to position tether (180). In particular, it may be desirable to guide tether (180) around lesion (L) or otherwise manipulate tether (180) relative to tissue. Thus, sharpened tip (262) and / or outer cannula (262) may be used to manipulate tether (180) relative to tissue. Such manipulation may be direct in some examples (e g., directly moving tether (180)) or indirect (e.g.. indirectly moving tether (180) by moving second biopsy site marker (140) using outer cannula (262)) in some uses.

[0048] After positioning outer cannula (262) and sharpened tip (263) as desired, second biopsy site marker (140) can be deployed. In particular, an operator can press plunger (270) of marker delivery device (250) to translate push rod (268) distally within outer cannula (262). Push rod (268) then drives lesion bracketing assembly (100) further distally to eject second biopsy site marker (110) from distal opening (264) in sharpened tip (263). Although the present use includes deployment of both first and second biopsy site marker (110, 140) from a single marker delivery device (250), it should be understood that in other uses, a dedicated marker delivery device (250) may be used for each of first biopsy site marker (110) and second biopsy site marker (140). In other words, first biopsy site marker (110) may be deployed from one outer cannula (262) of one marker delivery device (250), while second biopsy site marker (140) may be deployed from another outer cannula (262) of another marker delivery device (250).

[0049] Once second biopsy site marker (140) is deployed, one or more portions of second biopsy site marker (140) may optionally self-expand to secure second biopsy site marker (140) in a desired position proximate the margin of lesion (L). As described above, in the present example, second biopsy site marker (140) includes a shapememory alloy. Thus, in one use, second biopsy site marker (140) may absorb heat from surrounding tissue, which may transition second biopsy site marker (140) from the pre-depl oyment configuration to the post-deployment configuration described above. In other uses, various alternative self-expansion actions may occur at this stagevia heat from surrounding tissue or other suitable mechanisms such as moisture, the release of a retaining force applied by outer cannula (262), or the release of a retaining force applied by other external components. Regardless of the mechanism, it should be understood that in uses with self-expansion actions, relatively quick mechanisms of self-expansion are generally desirable over relatively slow mechanisms of self-expansion (e.g., seconds or minutes versus hours).

[0050] After both first biopsy site marker (110) and second biopsy site marker (140) are deployed as described above, marker delivery device (250) can be removed, leaving lesion bracketing assembly (100) in position. Optionally, the patient tissue may be closed at this stage and lesion bracketing assembly (100) may remain in position until a later resection. Alternatively, resection may occur shortly after deployment of lesion bracketing assembly (100), without the need for patient closure.

[0051] Regardless, lesion bracketing assembly (100) may be used to both identify the location of lesion (L) and guide an operator with respect to the margin of lesion (L) during resection. In particular, one or more portions of one or both of markers (110, 140) or tether (180) may be configured for identification under one or more forms of imaging guidance such as ultrasound guidance, x-ray guidance, and / or etc. Such imaging guidance may be used to locate the position of lesion (L) within tissue using first biopsy site marker (110), second biopsy site marker (140), tether (180), or a combination thereof. In addition, or in the alternative, one or more portions of one or both of markers (110, 140) or tether (180) may be identified using non-imaging localization techniques such as magnetic detection and / or radio frequency localization.

[0052] Once lesion (L) is located, lesion bracketing assembly (100) may be used to guide resection of lesion (L). In particular, an operator may begin resection at either first biopsy site marker (110) or second biopsy site marker (140). Tether (180) may then be used to guide resection using visual feedback, tactile feedback, or combinations thereof. For instance, stating with first biopsy site marker (110) positioned on one side of the margin of lesion (L), tether (180) may guide an operator to second biopsysite marker (140) positioned on another side of the margin of lesion (L). In other words, tether (180) may be used to trace a path of resection from one side of the margin of lesion (L) to the other using first biopsy site marker (110) and second biopsy site marker (140) as fixed reference points corresponding to opposing sides of the margin of lesion (L).

[0053] At the conclusion of resection, lesion bracketing assembly (100) may optionally be removed along with lesion (L). Alternatively, in some uses, lesion bracketing assembly (100) may be left in position for use in identifying the site of resection during subsequent follow-up procedures. In uses where lesion bracketing assembly (100) remains in position, it may be desirable for one or more portions of lesion bracketing assembly (100) to be dissolvable or bioabsorbable. For instance, as described above, tether (180) may include a dissolvable suture material. Thus, uses with such examples, tether (180) may dissolve or absorb, thereby leaving first biopsy site marker (110) and second biopsy site marker (140) in position.

[0054] III. Exemplary Combinations

[0055] Example 1

[0056] A method for bracketing a margin of a lesion, the method comprising: deploying a first biopsy site marker from a cannula proximate a first side of the margin of the lesion; deploying a second biopsy site marker from the cannula proximate a second side of the margin of the lesion, the first biopsy site marker being connected to the second biopsy site marker by a tether; and using the tether to locate the first side and the second side of the margin of the lesion.

[0057] Example 2

[0058] The method of Example 1, the second side of the margin of the lesion being opposite the first side of the margin of the lesion.

[0059] Example 3

[0060] The method of Examples 1 or 2, the step of using the tether to locate the first aide and the second side including identifying the first marker, the second marker, or the tether using an imaging modality.

[0061] Example 4

[0062] The method of Example 3, the imaging modality including x-ray imaging or ultrasound imaging.

[0063] Example 5

[0064] The method of any of Examples 1 through 4, further comprising guiding the tether around a portion of the lesion using the cannula after the step of deploying the first biopsy site marker from the cannula.

[0065] Example 6

[0066] The method of any of Examples 1 through 5, further comprising expanding a portion of the first biopsy site marker after the step of deploying the first biopsy site marker.

[0067] Example 7

[0068] The method of Example 6, the step of expanding the portion of the first biopsy site marker including transitioning a solid marker element of the first biopsy site marker from a pre-depl oym ent configuration to a post-deployment configuration.

[0069] Example 8

[0070] The method of Examples 6 or 7, the portion of the first biopsy site marker being selfexpanding such that the step of expanding the portion of the first biopsy site marker is performed automatically.

[0071] Example 9

[0072] The method of any of Examples 1 through 8, further comprising expanding a portion of the second biopsy site marker after the step of deploying the second biopsy site marker.

[0073] Example 10

[0074] The method of any of Examples 1 through 8, the step of expanding the portion of the second biopsy site marker including transitioning a solid marker element of the second biopsy site marker from a pre-deployment configuration to a post-deployment configuration.

[0075] Example 11

[0076] The method of Examples 9 or 10, the portion of the first biopsy site marker being self-expanding such that the step of expanding the portion of the first biopsy site marker is performed automatically.

[0077] Example 12

[0078] The method of any of Examples 1 through 11, further comprising holding the second biopsy site marker within the cannula during the step of deploying the first biopsy site marker from the cannula.

[0079] Example 13

[0080] The method of any of Examples 1 through 12, the step of deploying the first biopsy site marker from the cannula being performed prior to performing the step of deploying the second biopsy site marker from the cannula.

[0081] Example 14

[0082] The method of any of Examples 1 through 13, the step of deploying the first biopsy site marker from the cannula and the step of deploying the second biopsy site marker from the cannula being performed during the same procedure.

[0083] Example 15

[0084] The method of any of Examples 1 through 14, the step of deploying the first biopsy site marker from the cannula and the step of deploying the second biopsy site marker from the cannula being performed with a single cannula.

[0085] Example 16

[0086] A system for bracketing a margin of a lesion, the system comprising: a tether; a first biopsy site marker, the first biopsy site marker including one or more self-expanding elements configured to move relative to a base portion of the first biopsy site marker; and a second biopsy site marker, the tether extending from the first biopsy site marker to the second biopsy site marker, the second biopsy site marker including one or more self-expanding elements configured to move relative to a base portion of the second biopsy site marker.

[0087] Example 17

[0088] The system of Example 16, the tether including an elongate flexible material.

[0089] Example 18

[0090] The system of Example 17, the tether including a bioabsorbable material.

[0091] Example 19

[0092] The system of any of Examples 16 through 18, the first biopsy site marker and the second biopsy site marker both including a shape-memory alloy, the shape-memory alloy being configured to drive movement of each of the one or more self-expanding elements of both the first biopsy site marker and the second biopsy site marker.

[0093] Example 20

[0094] A method for identifying the margin of a lesion, the method comprising: locating a first biopsy site marker using image guidance; identifying a first portion of the marginof the lesion using the first biopsy site marker; tracing a path extending from the first biopsy site marker to a second biopsy site marker, the second biopsy site marker being positioned proximate a second portion of the margin, the second portion of the margin being opposite the first portion; and resecting the lesion based on the first portion of the margin and the second portion of the margin.

[0095] Example 21

[0096] The method of Example 20, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including tracing a tether extending from the first biopsy site marker to the second biopsy site marker.

[0097] Example 22

[0098] The method of Example 21, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including observing the tether.

[0099] Example 23[000100] The method of Examples 21 or 22, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including collecting tactile feedback from the tether.[000101] Example 24[000102] The method of any of Examples 20 through 23, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker being performed simultaneously with the step of resecting the lesion..[000103] IV. Conclusion[000104] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Assuch, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.[0001051 Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

We Claim:

1. A method for bracketing a margin of a lesion, the method comprising:(a) deploying a first biopsy site marker from a cannula proximate a first side of the margin of the lesion;(b) deploying a second biopsy site marker from the cannula proximate a second side of the margin of the lesion, the first biopsy site marker being connected to the second biopsy site marker by a tether; and(c) using the tether to locate the first side and the second side of the margin of the lesion.

2. The method of claim 1, the second side of the margin of the lesion being opposite the first side of the margin of the lesion.

3. The method of claims 1 or 2, the step of using the tether to locate the first side and the second side including identifying the first marker, the second marker, or the tether using an imaging modality.

4. The method of claim 3, the imaging modality including x-ray imaging or ultrasound imaging.

5. The method of any of claims 1 through 4, further comprising guiding the tether around a portion of the lesion using the cannula after the step of deploying the first biopsy site marker from the cannula.

6. The method of any of claims 1 through 5, further comprising expanding a portion of the first biopsy site marker after the step of deploying the first biopsy site marker.

7. The method of claim 6, the step of expanding the portion of the first biopsy site marker including transitioning a solid marker element of the first biopsy site marker from a predeployment configuration to a post-deployment configuration.

8. The method of claims 6 or 7, the portion of the first biopsy site marker being selfexpanding such that the step of expanding the portion of the first biopsy site marker is performed automatically.

9. The method of any of claims 1 through 8, further comprising expanding a portion of the second biopsy site marker after the step of deploying the second biopsy site marker.

10. The method of any of claims 1 through 8, the step of expanding the portion of the second biopsy site marker including transitioning a solid marker element of the second biopsy site marker from a pre-deployment configuration to a post-deployment configuration.

11. The method of claims 9 or 10, the portion of the first biopsy site marker being self-expanding such that the step of expanding the portion of the first biopsy site marker is performed automatically.

12. The method of any of claims 1 through 11, further comprising holding the second biopsy site marker within the cannula during the step of deploying the first biopsy site marker from the cannula.

13. The method of any of claims 1 through 12, the step of deploying the first biopsy site marker from the cannula being performed prior to performing the step of deploying the second biopsy site marker from the cannula.

14. The method of any of claims 1 through 13, the step of deploying the first biopsy site marker from the cannula and the step of deploying the second biopsy site marker from the cannula being performed during the same procedure.

15. The method of any of claims 1 through 14, the step of deploying the first biopsy site marker from the cannula and the step of deploying the second biopsy site marker from the cannula being performed with a single cannula.

16. A system for bracketing a margin of a lesion, the system comprising:(a) a tether;(b) a first biopsy site marker, the first biopsy site marker including one or more self-expanding elements configured to move relative to a base portion of the first biopsy site marker; and(c) a second biopsy site marker, the tether extending from the first biopsy site marker to the second biopsy site marker, the second biopsy site marker including one or more self-expanding elements configured to move relative to a base portion of the second biopsy site marker.

17. The system of claim 16, the tether including an elongate flexible material.

18. The system of claim 17, the tether including a bioabsorbable material.

19. The system of any of claims 16 through 18, the first biopsy site marker and the second biopsy site marker both including a shape-memory alloy, the shape-memory alloy being configured to drive movement of each of the one or more self-expanding elements of both the first biopsy site marker and the second biopsy site marker.

20. A method for identifying the margin of a lesion, the method comprising:(a) locating a first biopsy site marker using image guidance;(b) identifying a first portion of the margin of the lesion using the first biopsy site marker;(c) tracing a path extending from the first biopsy site marker to a second biopsy site marker, the second biopsy site marker being positioned proximate a second portion of the margin, the second portion of the margin being opposite the first portion; and(d) resecting the lesion based on the first portion of the margin and the second portion of the margin.

21. The method of claim 20, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including tracing a tether extending from the first biopsy site marker to the second biopsy site marker.

22. The method of claim 21, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including observing the tether.

23. The method of claims 21 or 22, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker including collecting tactile feedback from the tether.

24. The method of any of claims 20 through 23, the step of tracing the path extending from the first biopsy site marker to the second biopsy site marker being performed simultaneously with the step of resecting the lesion.

Images