WO2024206458A1

WO2024206458A1 - Biopsy site marker with light emission

Info

Publication number: WO2024206458A1
Application number: PCT/US2024/021700
Authority: WO
Inventors: Kyle D. WAGNER; James O. Rogers
Original assignee: Devicor Medical Products Inc
Current assignee: Devicor Medical Products Inc
Priority date: 2023-03-28
Filing date: 2024-03-27
Publication date: 2024-10-03
Anticipated expiration: 2025-09-28

Abstract

A biopsy site marker includes a coil of wire, an illuminator, and an outer shell. The illuminator may produce light in response to an electrical current communicated from the coil of wire. The outer shell encapsulates the coil of wire and illuminator.

Description

BIOPSY SITE MARKER WITH LIGHT EMISSION

PRIORITY

[00001] This application claims priority to U.S. Provisional Patent App. No. 63/455,124, entitled “Biopsy Site Marker with Light Emission” filed on March 28, 2023, the disclosure of which is hereby incorporated by reference herein.

BACKGROUND

[00002] 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 the irregular 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.

[00003] 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.

[00004] In some contexts, a marker is located with the use of ultrasound or x-ray technology. This location method requires additional equipment. Alternatively, sometimes visible wires will protrude from the patient’s skin to pinpoint the location of the marker. Such wires may be inconvenient or uncomfortable for the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[00005] 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.

[00006] FIG. 1 depicts a side elevational view of an exemplary biopsy site marker element;

[00007] FIG. 2 depicts a side elevational view of the marker element of FIG. 1, the marker element being disposed within carrier;

[00008] FIG. 3 depicts a perspective view of an exemplary marker delivery device for use with the marker element of FIG. 1;

[00009] FIG. 4A depicts a perspective view of the marker element of FIG. 1 being deployed from the marker delivery device of FIG. 3 and through a lateral aperture in a biopsy needle to mark a biopsy site;

[00010] FIG. 4B depicts a perspective view of the marker element of FIG. 1 after being deployed from the marker delivery device of FIG. 3 and through a lateral aperture in a biopsy needle to mark a biopsy site;

[00011] FIG. 5 A depicts a perspective view of the marker element of FIG. 1 after being deployed; [00012] FIG. 5B depicts the activation of an illuminator of the marker element of FIG. 1.

[00013] FIG. 6 depicts a perspective view of an energy conduit that can be used in combination with the marker element of FIG. 1.

[00014] 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

[00015] 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.

[00016] 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.

[00017] Once a marker is positioned in a biopsy site, it may be desirable for the marker to remain visible. For instance, it may be desirable for the marker to produce light that penetrates the skin and is visible to the naked eye. Alternatively, for markers that are implanted deep under the skin, it may be desirable for the marker to produce infrared light. In such examples, goggles or glasses could be used to view the light emitted by the marker.

[00018] I. Example of Biopsy Site Marker with Light Emission

[00019] FIG. 1 shows an exemplary marker (100) that is generally configured to emit light from an illuminator (104) to thereby assist in locating the marker after deployment. Marker (100) of the present version includes a marker element (108). Marker element (108) can be generally configured as non-bioabsorbable (e.g., permanent or semi-permanent) and radiopaque and/or echogenic to enhance visualization over time. Marker element (108) includes a power source (102), an illuminator (104), a circuitry assembly (106), and an outer shell (110).

[00020] In present version, power source (102) is configured as a coil of wire. The individual coils of wire are wrapped around a common axis so that the coil of wire itself defines a longitudinal axis. In some versions, the longitudinal axis defined by the coil of wire may be aligned with a longitudinal axis defined by marker element (108) and/or marker (100). In some versions, power source (102) is configured as a battery in communication with one or more portions of marker (100). In such versions, the battery may be separate from marker (100) or integrated into a portion of marker (100). In other versions, power source (102) is configured as an assembly that can draw power from the heat of a patient’s body.

[00021] Illuminator (104) includes one or more light emitters in the form of light emitting diodes such that illuminator (104) is generally configured to emit light of one or more wavelengths. In some versions, illuminator (104) is configured as an array of light emitting diodes in communication with each other to illuminate together or independently of each other. Illuminator (104) may be configured as an array of light emitting diodes arranged in a plurality of rows extending parallel to each other. In other versions, illuminator (104) is configured as a circular array of light emitting diodes. In still other versions, illuminator (104) is configured of both light emitting diodes that emit visible light and light emitting diodes that emit infrared light.

[00022] Illuminator (104) may not be limited to only a light emitting element. In some examples, illuminator (104) may be configured to emit other forms of energy, such as ultrasonic energy via an ultrasound transducer. In such embodiments, ultrasound energy may be emitted in addition to a light emission or in-lieu of a light emission. Thus, in some examples, illuminator (104) can include an ultrasound transducer either in addition to, or in lieu of, light emitting diodes or other illumination sources. Such emission of ultrasound may be desirable in some examples to further facilitate locating marker (100) within tissue. For instance, emission of ultrasound may be detectable by an ultrasonic transducer used as a part of an ultrasound imaging system, which may be used to visualize marker (100) under ultrasound.

[00023] As described above, illuminator (104) is configured to produce one or more wavelengths of light. In some versions, such emitted light may be within the visible light spectrum. In other versions, such as those where marker (100) is configured for implantation in relatively deep positions in the body, illuminator (104) is configured to produce wavelengths within infrared light spectrum. Generally, the particular type of infrared light emitted may be based on the type of tissue marker (100) is configured for implantation within. For instance, when marker (100) is configured for implantation within fat or shallow muscle, illuminator (104) may be configured to produce near field infrared light spectrum. Alternatively, when marker (100) is implanted deeply into muscle, illuminator (104) may be configured to produce far infrared light. In some versions, illuminator (104) is configured to emit an intermittent flashing light. As will be described in greater detail below, in such configurations, emissions of intermittent flashing light may be desirable to provide real time feedback related to the position of marker (100) relative to other elements.

[00024] As shown in FIG. 1, power source (102) is in communication with illuminator (104) via a circuitry assembly (106). Power source (102) of the present version is generally configured to receive or harvest energy transmitted to it by an external electromagentic field. In other words, power source (102) is configured to receive electromagnetic radiation from a power transmitter (500), generate power using the electromagnetic radiation. Such generated power can then be communicated to illuminator (104) via circuitry assembly (106). Thus, power source (102) is configured to communicate an electrical current to illuminator (104).

[00025] Outer shell (110) is configured to encapsulate both power source (102) and illuminator (104). Outer shell (110) is transparent to permit light to pass through. In some versions, outer shell (110) is biocompatible and non-absorbable. In some versions, outer shell (110) is comprised of polymers. In some versions, outer shell (110) is cylindrical or pill-shaped. In other versions, outer shell (110) is the shape of a rectangular prism. In some versions, outer shell (110) is hollow. In other versions, outer shell (110) is filled with a solid or viscous material that marker (100) and other components are embedded within. In still other versions, outer shell (110) is configured as a solid hydrogel carrier that may fully encapsulate elements of marker (100) such as marker element (108) including illuminator (104), power source (102), and/or circuitry assembly (106).

[00026] Circuitry assembly (106) is generally configured to manipulate electric current produced by power source (102) to render the current suitable to drive illuminator (104). Thus, circuitry assembly (106) may include one or more resistors, transistors, capacitors, inductors, diodes, integrated circuits, various combinations thereof, and/or etc. In other versions, circuitry assembly (106) could include a battery. Circuitry assembly (106) could be configured to regulate the voltage and electromagnetic energy being communicated by power source (102) to illuminator (104). Optionally, in some versions, circuitry assembly (106) may be used to provide additional functional features to illuminator (104) such as on-off patterns, adjustment of emitted wavelengths, on-off timers, and/or etc.

[00027] In some examples, circuitry assembly (106) includes one or more capacitors configured to be charged to a target threshold. In such examples, the one or more capacitors are in communication with both power source (102) and illuminator (104) to both receive power from power source (102) and then communicate such power to illuminator (104) at predetermined intervals. As will be described in greater detail below, the one or more capacitors may be configured to cycle through one or more charge-discharge cycles to intermittently power illuminator (104) and thereby generate a predetermined pattern of illumination or other signal emission. In some examples, such patterns may vary as a function of the power communicated to the one or more capacitors by power source (102).

[000281 In some examples, the closer marker (100) is to power transmitter (500), the more frequently power source (102) sends power to illuminator (104). There may be a proportional relationship between the distance separating marker (100) from power transmitter (500) and the frequency with which power source (102) communicates with illuminator (104). In other words, the time in between each instance of power source (102) sending power to illuminator (104) is directly related to how close marker (100) is from power transmitter (500).

[00029] In some examples, illuminator (104) produces an intermittent flashing light. In such examples, the closer marker (100) is to power transmitter (500), the faster the speed of the intermittent flashing light. There may be a proportional relationship between the distance separating marker (100) from power transmitter (500) and the frequency of the intermittent flashing light.

[00030J Current induced in power source (102) varies as a function of distance from power transmitter (500). By way of example only, this relationship can be implemented through the use of the one or more capacitors described above. For instance, the one or more capacitors can be configured to activate illuminator (104) at a variable frequency using charge and discharge cycles of the one or more capacitors. Regardless of the particular implementation, varying illumination as a function of distance may be desirable to provide real-time feedback as to the position of marker (100) relative to power transmitter (500). Alternatively, a more complex digital circuit could be used to produce the same real-time feedback via illuminator (104) being activated at a variable frequency. [00031] Marker (100) of the present example is large enough to be readily visible to a clinician under x-ray or ultrasonic viewing, for example; yet small enough to be able to be percutaneously deployed into the biopsy cavity. Aspects presented herein may be used for markers in any internal, tissue, e.g., in breast tissue, lung tissue, prostate tissue, lymph gland tissue, etc.

[00032] As best seen in FIG. 2, marker (100) may optionally include a carrier (200). Carrier (200) generally includes abioabsorbable marker material (212) such as collagen and/or hydrogel. Thus, carrier (200) is generally configured for absorption into a patient after placement of marker (100) within the biopsy cavity. In some versions, marker element (108) is centered in the middle of carrier (200). In other versions, marker element (108) is aligned with a horizontal and/or vertical axis relative to carrier (200).

[00033] Marker element (108) may include a radiopaque or echogenic marker embedded within the bioabsorbable marker material of carrier (200). For instance, marker element (108) may comprise metal, hard plastic, or other radiopaque or hyperechoic materials known to those of ordinary skill in the art in view of the teachings herein. By way of example only, power source (102) may function as such a radiopaque or echogenic marker suitable for visualization under x-ray or ultrasound visualization. For instance, as described above, power source (102) may include a coil of wire. Such coils of wire may be visible under x-ray visualization by virtue of the relative density of the wire. Similarly, such coils of wire may be visible under ultrasound visualization by virtue of the coil shape providing a plurality of normal surfaces that may be suitable to reflect ultrasonic radiation.

[00034] Although marker (100) of the present version includes carrier (200), it should be understood that carrier (200) is merely optional and may be omitted in some versions. For instance, marker (100) may be formed with only marker element (108) such that carrier (200) is omitted and marker element (108) is in a “bare” form. In other words, in some examples marker (100) is formed of only marker element (108) as a bare element without a coating similar to carrier (200). [00035] Marker material (212) is generally expandable once disposed within a patient at a biopsy site. The initially dehydrated marker material (212) may absorb fluid from the surrounding tissue into which it is inserted. In response to this absorption of fluid, maker material (212) may swell, thereby permitting carrier (200) to fill a cavity formed at a biopsy site by removal of tissue samples during a biopsy procedure. Biodegradable materials may be particularly suitable in applications where it is desired that natural tissue growth be permitted to completely or partially replace the implanted material over time. Accordingly, biocompatibility is ensured and the natural mechanical parameters of the tissue are substantially restored to those of the pre-damaged condition.

[00036] The hydration of marker material (212) of carrier (200) by the natural moisture of the tissue surrounding it causes expansion of the polymer and thus minimizes the risk of migration. The growing hydrogel based marker material (212) centers marker (100) in the biopsy cavity as it grows. In some versions, carrier (200) is defined by a cylindrical shape.

[00037] II. Exemplary Marker Delivery Device

[00038] In some circumstances it may be desirable to deploy marker (100) described above within the body cavity using certain marker delivery devices. For instance, FIG. 3 shows an exemplary marker delivery device (312) which includes an elongate outer cannula (306) having a marker exit, such as side opening (308) formed adjacent to, but spaced proximally from, a distal end (310) of the cannula (306).

[00039] A grip (304) can be provided at the proximal end of cannula (306). A push rod (302) can be provided, with push rod (302) extending coaxially in cannula (306) such that push rod (302) is configured to translate within cannula (306) to displace one or more markers through side opening (308). Rod (302) may have sufficient rigidity in compression to push a marker from an internal lumen of cannula (306) out through opening (308), yet be relatively flexible in bending. A plunger (300) is coupled at the proximal end of rod (302) for forcing rod (302) distally in cannula (306) to deploy a marker out of cannula (306).

[00040] A user may grasp grip (304) with two fingers, and may push on plunger (300) using the thumb on the same hand, so that marker delivery device (312) is operated by a user's single hand. A spring (not shown) or other feature may be provided about rod (302) to bias rod (302) proximally relative to grip (304) and cannula (306).

[00041] Cannula (306) may be formed of any suitable metallic or non-metallic material. In some versions, cannula (306) 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. Cannula (306) may be formed of PEBAX, and may be substantially transparent to visible light and X-ray.

[00042] Side opening (308) may be formed by cutting away a portion of the wall of cannula (306). Side opening (308) communicates with an internal lumen of cannula (306). Side opening (308) may extend axially (in a direction parallel to the axis of lumen) from a proximal opening end to a distal opening end. In some versions, side opening (308) may be configured as an opening in the distal end of cannula (306).

[00043] III. Exemplary Use

[00044] Aspects presented herein relate to devices and procedures for using a marker for percutaneously marking a biopsy cavity having surrounding tissue, as shown in FIGS. 4A-4B. FIGS 4A-4B show marker delivery device (312) being used to deploy marker (100) to mark a biopsy location with a patient. A cannular biopsy needle (400) is shown. Optionally, cannula (306) of marker delivery device (312) is introduced to a biopsy site through biopsy needle (400), which may be the same needle (400) used to collect a tissue sample from the biopsy site. Alternatively, in other uses, marker delivery device (312) may be used with other cannular structures for deployment such as introducers. In still other uses, marker deliver device (312) may be used without any additional components. Biopsy needle (400) may be of the type used with single insertion, multiple sample vacuum assisted biopsy devices. Several such biopsy devices are disclosed in the various patents and patent applications that have been referred to and incorporated by reference herein, though other biopsy devices may be used.

[00045] Distal end (310) of marker delivery device (312) is disposed within needle (400). Needle (400) may be positioned in tissue, and a biopsy sample may be obtained through lateral aperture (402), thereby providing a biopsy cavity adjacent lateral aperture (402). Then, after the tissue sample has been obtained and transferred proximally through needle (400), and without removing needle (400) from the patient's tissue, marker delivery device (312) is inserted into a proximal opening in needle (400). Needle (400) and marker delivery device (312) are positioned such that opening (308) of cannula (306) and needle (400) are substantially aligned axially and circumferentially. Then, with marker delivery device (312) and needle (400) so positioned at the biopsy site, push rod (302) is advanced to deploy marker (100) through opening (308) and into the biopsy cavity.

[00046] FIGS 4A-4B show the marking of a biopsy cavity having surrounding tissue. As seen in FIG. 4A, a marker (100) may be initially placed in the biopsy cavity to facilitate relocation of the biopsy site. As noted above, marker (100) may comprise a carrier (200) and a marker element (108). Carrier (200) generally includes a bioabsorbable marker material. Thus, carrier (200) is generally configured for absorption into a patient after placement of marker (100) within the biopsy cavity. Marker material (212) is generally bioabsorbable such that marker material (212) may be generally absorbed into the patient’s tissue over time. In the present example, marker material (212) comprises a hydrogel that is initially in a dehydrated state. Although a hydrogel is used in the present example, it should be understood that in other examples marker material (212) may comprise other known bioabsorbable materials.

[00047] FIGS. 5A-5B show marker (100) in position in a patient’s body cavity after deployment. Marker (100) can be located by the activation of illuminator (104). After marker (100) has been deployed in a patient’s body cavity, a clinician can activate illuminator (104) with a power transmitter (500). In some versions, power transmitter (500) includes a switch (502) and a power source (504). In some versions, power source (504) is configured as a coil of wire. In some versions, switch (502) is a button that clinician may press to activate illuminator (104). In some versions, power transmitter (500) is a hand-held device.

[00048] When power transmitter (500) is activated, electromagnetic energy is transferred to power source (102) wirelessly similarly to transmission described above. Then, power source (102) transfers the energy through circuitry assembly (106) to illuminator (104), thus activating illuminator (104). In some versions, an operator may activate power transmitter (500) by bringing power transmitter (500) into proximity of the patient and turning it on.

[00049] In some versions, once illuminator (104) is activated, marker (100) would appear to glow to the human eye. This light would lead a clinician to the precise location of marker (100). In other versions, such as when marker (100) is deployed deeper into a patient’s body, illuminator (104) would display infrared light. In versions in which infrared light is used, goggles or glasses could be used to view light emitted by illuminator (104).

[00050] Other noninvasive detection techniques, such as x-ray mammography or ultrasound, may then be used by the physician to identify, locate, and monitor the biopsy cavity site over a period of time via marker (100).

[00051] FIG. 6 shows an energy conduit (620). Energy conduit (620) may be a handheld device. Energy conduit (620) may be used in addition to or in lieu of power transmitter (500) for communication of power with marker (100) either using energy conduit (620), power transmitter (500), or both. As will be described in greater detail below, in some examples aspects of power transmitter (500) may be readily incorporated into energy conduit (620). In configurations in which energy conduit (620) is used in addition to power transmitter (500), power transmitter (500) is activated to send electromagnetic energy to power source (102) wirelessly similarly to transmission described above. Then, power source (102) transfers the energy through circuitry assembly (106) to illuminator (104), thus activating illuminator (104). In some versions, an operator may activate power transmitter (500) by bringing power transmitter (500) into proximity of the patient and turning it on.

[00052] Alternatively, energy conduit (620) may include a power transmitter (600) that is substantially similar to power transmitter (500) above. In such embodiments, energy conduit (620) may further include a user guidance interface (622) to communicate with a user. In some examples, user guidance interface (622) includes a display screen for the user to see, such as an LED screen, which may be configured to graphically depict a position of marker (100) relative to one or more references. In other examples, user guidance interface (622) includes a speaker to give the user audible cues, which may correspond to the position of marker relative to energy conduit (620).

[00053] Energy conduit (620) may further include a sensing capability piece (624). Sensing capability piece (624) may be configured to be responsive to the energy emitted by marker (100). In some examples, sensing capability piece (624) includes one or more sensors configured to detect emissions within the infrared spectrum. In other examples, sensing capability piece (624) includes one or more sensors configured to detect emissions within the ultrasound spectrum, either in addition to or in-lieu of detection within the infrared spectrum.

[00054] Energy conduit (620) can be used by a medical professional to observe and interpret the position and status of marker (100). For example, power transmitter (600) may activate illuminator (104) of marker (100). Next, sensing capability piece (624) may receive signals from illuminator (104) and communicate those signals to user guidance interface (622), such as an LED screen. Then, a user may view the LED screen and/or listen to audible tones from the speaker to get a sense of marker’s (100) position.

[00055] In some versions, the closer power transmitter (600) is to marker (100) when a clinician engages power transmitter (600), the faster power source (102) transfers power to illuminator (104). In some examples, illuminator (104) may intermittently flash a light. In such examples, the closer power transmitter (600) is to marker (100), the faster illuminator (104) will flash a light. In this way, a clinician may move power transmitter (600) around the surface of a biopsy site and observe the flashing light to determine the location of marker (100). In some examples, power transmitter (600) may be used in combination with a stereoscopic detector array. In such examples, the speed of the intermittent flashing light may be used mathematically to precisely position marker (100) relative to the stereoscopic detector ray in three dimensions.

[00056] IV. Exemplary Combinations

[00057] Example 1

[00058] A biopsy site marker, comprising a marker element, the marker element including: (a) a coil of wire; (b) an illuminator, the illuminator being configured to produce light in response to an electrical current communicated from the coil of wire; and (c) an outer shell, the outer shell encapsulating the coil of wire and illuminator.

[00059] Example 2

[00060] The marker of Example 1, the coil of wire being configured to harvest energy transmitted by an electric field.

[00061] Example 3

[00062] The marker of any of Examples 1 or 2, the coil of wire being configured to receive electromagnetic radiation from a power transmitter to drive illumination of the illuminator.

[00063] Example 4

[00064] The marker of any of Examples 1 through 3, the illuminator configured to produce visible light.

[00065] Example 5 [00066] The marker of any of Examples 1 through 4, the illuminator configured to produce infrared light.

[00067] Example 6

[00068] The marker of any of Examples 1 through 5, the illuminator including an array of lightemitting diodes.

[00069] Example 7

[00070] The marker of any of Examples 1 through 6, the marker further comprising a carrier, the carrier being configured to expand in diameter in response to moisture.

[00071] Example 8

[00072] The marker of Example 7, the carrier being bioabsorbable, the marker element being non-bioabsorbable.

[00073] Example 9

[00074] The marker of any of Examples 7 or 8, the carrier defining a cylindrical shape.

[00075] Example 10

[00076] The marker of any of Examples 7 through 9, the carrier defining a first axial length, the outer shell of the marker element defining a second axial length, the first axial length being longer than the second axial length.

[00077] Example 11

[00078] The marker of any of Examples 7 through 10, the carrier including a collagen material.

[00079] Example 12

[00080] The marker of any of Examples 7 through 11, the carrier including a hydrogel material.

[00081] Example 13 [00082] A biopsy site marker, comprising: (a) a carrier, the carrier being configured to expand in diameter in response to moisture; and (b) a marker element, the marker element including: (i) a coil of wire, the wire configured to harvest energy transmitted by an electric field; (b) an illuminator, the illuminator being configured to produce light using the harvested energy from the coil of wire; and (c) an outer shell, the outer shell encapsulating the coil of wire and illuminator.

[00083] Example 14

[00084] The biopsy marker site of Example 13, the illuminator being configured to produce infrared light.

[00085] Example 15

[00086] The biopsy marker site of any of Examples 13 or 14, the illuminator including an array of light-emitting diodes.

[00087] Example 16

[00088] The biopsy marker site of any of Examples 13 through 15, the carrier being coupled to a portion of the marker element, the carrier being bioabsorbable.

[00089] Example 17

[00090] The biopsy marker site of any of Examples 13 through 16, the carrier being 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.

[00091] Example 18

[00092] A method comprising: (a) inserting a marker delivery device into tissue to position a deployment opening of a cannula at a biopsy site; (b) actuating a push rod from the deployment opening of the cannula into the biopsy site; and (c) emitting a light from the biopsy site marker by placing a power transmitting proximate the biopsy site marker. [00093] Example 19

[00094] A method for locating a biopsy site marker at a biopsy site after the biopsy site marker has been inserting, the method comprising: (a) transmitting energy to the biopsy site marker using a hand-held transmitter, such that the marker illuminates a light; and (b) observing the light illuminated by the marker.

[00095] Example 20

[00096] A biopsy marking system, the system comprising: (a) a biopsy site marker of any one or more of Examples 1 through 17; and (b) a marker deliver device, the marker delivery device including an introducer cannula, a grip, and a push rod, the introducer cannula being configured to receive the marker, the push rod being configured to move relative to the grip to eject the marker from a marker exit defined by the introducer cannula.

[00097] Example 21

[00098] A biopsy site marker, comprising a marker element, the marker element including: (a) a battery; (b) an illuminator, the illuminator being configured to produce light in response to an electrical current communicated from the battery; and (c) an outer shell, the outer shell encapsulating the battery and illuminator.

[00099] Example 22

[000100] A biopsy site marker, comprising: (a) a capacitor; (b) a receiver, the receiver in communication with the capacitor, the receiver being configured to respond to a signal from a transmitter; (c) an illuminator, the illuminator in communication with the capacitor such that the illuminator is configured to produce light; and (d) an outer shell, the outer shell encapsulating the capacitor, receiver, and illuminator, wherein the closer the biopsy site marker is to the transmitter, the faster the capacitor is configured to communicate an electrical current to the illuminator.

[000101] Example 23 [000102] The biopsy site marker of Example 22, wherein: (a) the capacitor is configured to discharge a communication to the illuminator; and (b) the frequency with which the capacitor discharges a communication to the illuminator is proportional to the distance between the marker and the transmitter.

[000103] Example 24

[000104] The biopsy site marker of any of Examples 22 through 23, the receiver being wireless.

[000105] Example 25

[000106] The biopsy site marker of any of Examples 22 through 24, the illuminator being configured to produce visible light.

[000107] Example 26

[000108] The biopsy site marker of any of Examples 22 through 25, the illuminator being configured to produce infrared light.

[000109] Example 27

[000110] The biopsy site marker of any of Examples 22 through 26, the illuminator including an ultrasonic transducer.

[000111] Example 28

[000112] The biopsy site marker of any of Examples 22 through 27, the illuminator being configured to produce an intermittent flashing light.

[000113] Example 29

[000114] The biopsy site marker of any of Examples 22 through 28, wherein the more frequently the capacitor discharges a communication with the illuminator, the more frequently the illuminator flashes a light.

[000115] Example 30 The biopsy site marker of any of Examples 22 through 29, wherein: (a) the illuminator is configured to intermittently flash a light; and (b) the frequency with which the illuminator flashes a light is proportional to the distance between the marker and the transmitter.

[000116] Example 31

[000117] A method for locating the biopsy site marker of any of Examples 22 through 30 at a biopsy site after the marker has been inserted into a patient, the method comprising: (a) transmitting energy to the marker using a hand-held transmitter, such that the marker illuminates an intermittent flashing light; (b) moving the transmitter around a surface of the patient; and (c) observing the intermittent flashing light illuminated by the marker.

[000118] Example 32

[000119] The method of Example 31, wherein moving the hand-held transmitter closer to the biopsy site marker increases the speed of the intermittent flashing light and moving the transmitter further from the marker decreases the speed of the intermittent flashing light.

[000120] Example 33

[000121] The method of any of Example 31 or 32, further comprising varying the frequency of the intermittent flashing light in proportion with the distance between the hand-held transmitter and the biopsy site marker.

[000122] Example 34

[000123] The method of any of Examples 31 through 33, wherein the hand-held transmitter includes a stereoscopic detector array.

[000124] Example 35 [000125] The method of any of Examples 31 through 34, wherein the speed of the intermittent flashing light is used to position the biopsy site marker relative to the stereoscopic detector array.

[000126] Example 36

[000127] An energy conduit, comprising: (a) a transmitter, the transmitter configured to communicate with the biopsy site marker of any of claims 22 through 30; (b) a sensing capability piece, the sensing capability piece configured to receive outputs from the biopsy site marker of any of claims 22 through 30; and (c) a guidance interface, the guidance interface configured to communicate with the sensing capability piece.

[000128] Example 37

[000129] The energy conduit of Example 36, wherein the guidance interface includes a lightemitting display screen.

[000130] Example 38

[000131] The energy conduit of any of Examples 36 or 37, wherein the guidance interface includes a speaker.

[000132] Example 39

[000133] The energy conduit of any of Examples 36 through 38, wherein the energy conduit is a handheld device.

[000134] Example 40

[000135] The energy conduit of any of Examples 36 through 39, wherein the sensing capability piece is configured to detect light within an infrared spectrum.

[000136] Example 41

[000137] The energy conduit of any of Examples 36 through 40, wherein the sensing capability piece is configured to detect radiation within an ultrasound spectrum. [000138] V. Conclusion

[000139] 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. As such, 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.

[000140] 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 biopsy site marker, comprising a marker element, the marker element including:

(a) a coil of wire;

(b) an illuminator, the illuminator being configured to produce light in response to an electrical current communicated from the coil of wire; and

(c) an outer shell, the outer shell encapsulating the coil of wire and illuminator.

2. The marker of claim 1, the coil of wire being configured to harvest energy transmitted by an electric field.

3. The marker of any of claims 1 or 2, the coil of wire being configured to receive electromagnetic radiation from a power transmitter to drive illumination of the illuminator.

4. The marker of any of claims 1 through 3, the illuminator configured to produce visible light.

5. The marker of any of claims 1 through 4, the illuminator configured to produce infrared light.

6. The marker of any of claims 1 through 5, the illuminator including an array of light-emitting diodes.

7. The marker of any of claims 1 through 6, the marker further comprising a carrier, the carrier being configured to expand in diameter in response to moisture.

8. The marker of claim 7, the carrier being bioabsorbable, the marker element being non-bioabsorbable.

9. The marker of any of claims 7 or 8, the carrier defining a cylindrical shape.

10. The marker of any of claims 7 through 9, the carrier defining a first axial length, the outer shell of the marker element defining a second axial length, the first axial length being longer than the second axial length.

11. The marker of any of claims 7 through 10, the carrier including a collagen material.

12. The marker of any of claims 7 through 11, the carrier including a hydrogel material.

13. A biopsy site marker, comprising:

(a) a carrier, the carrier being configured to expand in diameter in response to moisture; and

(b) a marker element, the marker element including: (i) a coil of wire, the wire configured to harvest energy transmitted by an electric field;

(ii) an illuminator, the illuminator being configured to produce light using the harvested energy from the coil of wire; and

(iii) an outer shell, the outer shell encapsulating the coil of wire and illuminator.

14. The biopsy site marker of claim 13, the illuminator being configured to produce infrared light.

15. The biopsy site marker of any of claims 13 or 14, the illuminator including an array of light-emitting diodes.

16. The biopsy site marker of any of claims 13 through 15, the carrier being coupled to a portion of the marker element, the carrier being bioabsorbable.

17. The biopsy site marker of any of claims 13 through 16, the carrier being 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.

18. A method comprising:

(a) inserting a marker delivery device into tissue to position a deployment opening of a cannula at a biopsy site; (b) actuating a push rod from the deployment opening of the cannula into the biopsy site; and

(c) emitting a light from the biopsy site marker by placing a power transmitting proximate the biopsy site marker.

19. A method for locating a biopsy site marker at a biopsy site after the biopsy site marker has been inserted, the method comprising:

(a) transmitting energy to the biopsy site marker using a hand-held transmitter, such that the marker illuminates a light; and

(b) observing the light illuminated by the marker.

20. A biopsy marking system, the system comprising:

(a) a biopsy site marker of any one or more of claims 1 through 17; and

(b) a marker delivery device, the marker delivery device including an introducer cannula, a grip, and a push rod, the introducer cannula being configured to receive the marker, the push rod being configured to move relative to the grip to eject the marker from a marker exit defined by the introducer cannula.

21. A biopsy site marker, comprising a marker element, the marker element including:

(a) a battery; (b) an illuminator, the illuminator being configured to produce light in response to an electrical current communicated from the battery; and

(c) an outer shell, the outer shell encapsulating the battery and illuminator.

22. A biopsy site marker, comprising:

(a) a capacitor;

(b) a receiver, the receiver in communication with the capacitor, the receiver being configured to respond to a signal from a transmitter;

(c) an illuminator, the illuminator in communication with the capacitor such that the illuminator is configured to produce light; and

(d) an outer shell, the outer shell encapsulating the capacitor, receiver, and illuminator, wherein the closer the biopsy site marker is to the transmitter, the faster the capacitor is configured to communicate an electrical current to the illuminator.

23. The biopsy site marker of claim 22, wherein:

(a) the capacitor is configured to discharge a communication to the illuminator; and

(b) the frequency with which the capacitor discharges a communication to the illuminator is proportional to the distance between the marker and the transmitter.

24. The biopsy site marker of any of claims 22 through 23, wherein the receiver is wireless.

25. The biopsy site marker of any of claims 22 through 24, the illuminator being configured to produce visible light.

26. The biopsy site marker of any of claims 22 through 25, the illuminator being configured to produce infrared light.

27. The biopsy site marker of any of claims 22 through 26, the illuminator including ultrasonic transducer.

28. The biopsy site marker of any of claims 22 through 27, the illuminator being configured to produce an intermittent flashing light.

29. The biopsy site marker of any of claims 22 through 28, wherein the more frequently the capacitor discharges a communication to the illuminator, the more frequently the illuminator flashes a light.

30. The biopsy site marker of any of Examples 22 through 29, wherein:

(a) the illuminator is configured to intermittently flash a light; and

(b) the frequency with which the illuminator flashes a light is proportional to the distance between the marker and the transmitter.

31. A method for locating the biopsy site marker of any of claims 22 through 30 at a biopsy site after the marker has been inserted into a patient, the method comprising:

(a) transmitting energy to the marker using a hand-held transmitter, such that the marker illuminates an intermittent flashing light;

(b) moving the transmitter around a surface of the patient; and

(c) observing the intermittent flashing light illuminated by the marker.

32. The method of claim 31, wherein moving the hand-held transmitter closer to the biopsy site marker increases the speed of the intermittent flashing light and moving the transmitter further from the marker decreases the speed of the intermittent flashing light.

33. The method of any of claims 31 or 32, further comprising varying the frequency of the intermittent flashing light in proportion with the distance between the hand-held transmitter and the biopsy site marker.

34. The method of any of claims 31 through 33, wherein the hand-held transmitter includes a stereoscopic detector array.

35. The method of any of claims 31 through 34, wherein the speed of the intermittent flashing light is used to position the biopsy site marker relative to the stereoscopic detector array.

36. An energy conduit, comprising: (a) a transmitter, the transmitter configured to communicate with the biopsy site marker of any of claims 22 through 30;

(b) a sensing capability piece, the sensing capability piece configured to receive outputs from the biopsy site marker of any of claims 22 through 30; and

(c) a guidance interface, the guidance interface configured to communicate with the sensing capability piece.

37. The energy conduit of claim 36, wherein the guidance interface includes a lightemitting display screen.

38. The energy conduit of any of claims 36 or 37, wherein the guidance interface includes a speaker.

39. The energy conduit of any of claims 36 through 38, wherein the energy conduit is a handheld device.

40. The energy conduit of any of claims 36 through 39, wherein the sensing capability piece is configured to detect light within an infrared spectrum.

41. The energy conduit of any of claims 36 through 40, wherein the sensing capability piece is configured to detect radiation within an ultrasound spectrum.