Radiation delivery devices

Abstract

Radioactive seeds may be attached to wrappers made of various bio-compatible materials such as plastics, polymers, or shielding materials. These wrappers may be inserted (at least partially) into a carrier (e.g., a collagen substrate) to position radioactive seeds at desired locations within the carrier. Wrappers may each have a single layer or multiple discrete layers, and some may include shielding materials. A wrapper may shield radiation in certain directions while allowing it to emit into the patient tissue for therapeutic purposes. The size of the wrapper opening can be customized for specific patients or treatment plans, enabling controlled radiation delivery areas.

Description

RADIATION DELIVERY DEVICESFIELD OF THE DISCLOSURE

[0001] The present disclosure generally relates to devices used in conjunction with radiation therapy.BACKGROUND

[0002] Tumors in living organisms are highly variable in size, location and their amount of infiltration into normal tissues, the variability of tumors in general make them very difficult to treat with a one-size fits all approach. Furthermore, the extent of tumors and / or void upon debulking are typically not known until presented in the operating room. Thus, the options necessary to effectively treat a tumor or tumor bed need to be quite diverse.

[0003] Brachytherapy involves placing a radiation source either into or immediately adjacent to a tumor. It provides an effective treatment of cancers of many body sites. Brachytherapy, as a component of multimodality cancer care, provides cost-effective treatment. Brachytherapy may be intracavitary, such as when treating gynecologic malignancies; intraluminal, such as when treating esophageal or lung cancers; external surface, such as when treating cancers of the skin, or interstitial, such as when treating various central nervous system tumors as well as extracranial tumors of the head and neck, lung, soft tissue, gynecologic sites, rectum, liver, prostate, penis and skin.SUMMARY

[0004] Tumors are difficult to eradicate surgically as their infiltrative nature often precludes microscopically complete resection without undue morbidity or mortality. This local persistence of tumor cells may be controlled if sufficient radiation can be delivered safely prior to regrowth and replication of the residual tumor cells. Debulking surgery, followed by radiation therapy may be used for local control of a tumor. Discussed herein are various systems, methods, and devices for use in conjunction with radiation therapy, such as to deliver (and to control delivery of) radiation to a post-operative tumor bed.Overview

[0005] To facilitate an understanding of the systems and methods discussed herein, several terms are described below. These terms, as well as other terms used herein, should be construed to include the provided descriptions, the ordinary and customary meanings of the terms, and / or any other implied meaning for the respective terms, wherein such construction is consistent with context of the term. Thus, the descriptions below do not limit the meaning of these terms, but only provide example descriptions.

[0006] Tumor: an abnormal growth of tissue resulting from uncontrolled, progressive multiplication of cells. Tumors can be benign or malignant.

[0007] Tumor bed: an anatomical area of a patient (e.g., a human or other mammal) where a tumor exists (pre-operative tumor bed) and / or an area surrounding a surgically removed tumor (post-operative tumor bed), such as a cranial cavity from which a tumor was surgically removed. Even after surgical removal of a tumor, the remaining tumor bed of the patient may include tumor cells.

[0008] Treatment area: an anatomical area that is targeted for delivery of radiation, such as from one or more radiation delivery devices (e.g., the carriers discussed below). A treatment area may include tissue below and / or around a location where the radiation deliver device is positioned, such as an anatomical area of a tumor or a tumor bed.

[0009] Treatment surface: an anatomical surface of a patient (e.g., a human or other mammal) where a radiation delivery device is to be placed to deliver radiation to a treatment area, such as the treatment surface itself and / or tissue below the treatment surface. A treatment surface may be a portion of a tumor bed or any other anatomical surface. For example, if a tumor bed is surgically created, the treatment surface may include an entire exposed surface of the tumor bed, a portion of such exposed surface, or the entire exposed surface of the tumor bed as well as a surrounding area of tissue.

[0010] Brachytherapy: radiation treatment in which the radiation delivery device is placed directly on and / or close to a treatment surface of the body, such as directly on the surface of the body, within the body, or in a tumor bed. For example,brachytherapy may be intracavitary, such as in cranial or gynecologic malignancies; intraluminal, such as in esophageal or lung cancers; external, such as in cancers of the skin; and / or interstitial, such as in treatment of various central nervous system tumors as well as extracranial tumors of the head, neck, lung, soft tissue, gynecologic sites, rectum, liver, prostate, and penis.

[0011] Seed: a radioactive material that is configured for delivery of radiation to a tumor and / or tumor bed. A seed may be in various shapes and sizes, such as cylinder, cone, sphere, pyramid, cube, prism, rectangular prism, triangular prism, and / or any combination of these or other shapes. While seeds are generally referred to herein as cylindrical, any other shape or size of seed may alternatively be used in the various systems and methods discussed herein. Seeds may comprise any combination of one or more of multiple radioactive components, such as Cs 131 , Ir 192, I 125, Pd 103, for example. Seeds may include a protective outer shell that partially or fully encases the radioactive material. Seeds are one form of radiation source. The term "radiation source,” as used herein, generally refers to a radioactive seed (or other object that emits radiation), either alone (e.g., a seed) or embedded, or otherwise attached to, a carrier (e.g., a tile carrier with an embedded radioactive seed).

[0012] Carrier: a substrate that holds or contains a radioactive seed. A carrier that contains one or more seeds is a radiation delivery device. Carriers may comprise various materials, such as one or more biocompatible and / or bioresorbable materials, such as collagen. Thus, these bioresorbable materials are biodegradable, or naturally absorbing into the mammalian tissue over time, such as over a period of weeks or months. Carriers may be configured for permanent implantation into a tumor bed, such as to provide radioactive energy to a treatment surface surrounding an area where a tumor has been removed in order to treat any remaining malignant tissue. Carriers can be composed of various materials and take on various shapes and sizes. Examples carriers, such as carriers having various sizes, shapes, configurations, etc., are included in the following patents and patent applications, each of which is hereby incorporated by reference in its entirety and for all purposes:• U.S. Patent Application No. 14 / 322,785, filed July 2, 2014, now U.S. Patent No.8,876,684, entitled “Dosimetrically Customizable Brachytherapy Carriers and Methods Thereof In The Treatment Of Tumors,” and• U.S. Patent Application No. 14 / 216,723, filed March 17, 2014, now U.S. Patent No. 9,492,683, entitled “Dosimetrically Customizable Brachytherapy Carriers and Methods Thereof In The Treatment Of Tumors.”

[0013] Tile Carrier (also referred to as “Tile”): type of carrier that is substantially planar and generally maintains a two-dimensional planar geometry when placed in a tumor bed. Depending on the material of the tile, though, the tile may be malleable such that the tile can be deformed by bending in order to better conform to a tumor bed. For example, for tiles comprising essentially collagen (and / or other malleable materials), the tiles may be substantially bent as placed in or on a treatment surface (and / or when pressed against the treatment surface) to conform with the shape of the treatment surface, such as a post-operative tumor bed.

[0014] Custom Carrier: a carrier having one or more non-planar surfaces, such as a spherical shape or having a spherical portion. Examples of custom carriers include Spherical Carriers, Gore Carriers, and Star Carriers, noted below, as well as other custom carriers discussed herein.

[0015] Spherical Carrier (or “GammaSphere”): a substantially radially symmetrical body around an axis. A spherical carrier may also include a non-spherical portion, such as a tapered portion that extends from a spherical portion. Examples of other variations of spherical carriers is discussed in Co-pending provisional application no. 63 / 163583, filed March 19, 2021 and entitled “Custom Brachytherapy Carriers,” which is incorporated by reference in its entirety and for all purposes.

[0016] Gore Carrier (also referred to as “Gore”): type of carrier that is 3- dimensional and conforms to the tumor bed while maintaining the geometry necessary for an effective implant. In some embodiments, gores are initially planar and are reconfigured to take on a 3-dimensional shape, such as to form a hemispherical surface that may be placed into a similarly shaped tumor cavity. Gore Carriers are further discussed in U.S. Patent No. 8,876,684, entitled “Dosimetrically customizable brachytherapy carriers and methods thereof in the treatment of tumors,” filed on July2, 2014 as Application No. 14 / 322,785, which is hereby incorporated by reference in its entirety and for all purposes.

[0017] Star Carrier (also referred to as “Star” or “arm-based carrier”): type of carrier that assumes a conformable 3-dimensional shape when arranged and placed into an operative cavity or similar space and conforms to the treatment environment while maintaining the geometry necessary for an effective implant. However, in some embodiments, Star carriers may be used in their initial planar state to cover a relatively flat tumor or tumor bed area. Star carriers are further discussed in U.S. Patent No. 9,492,683, entitled “Dosimetrically customizable brachytherapy carriers and methods thereof in the treatment of tumors,” filed on March 17, 2014 as Application No. 14 / 216,723, which is hereby incorporated by reference in its entirety and for all purposes.

[0018] Loader: a device that aids in placement of radioactive seeds in carriers, such as via injection of seeds into carriers. A loader, also referred to herein as a “loading device,” may include multiple components, such as to hold a carrier in place and guide a delivery device (e.g., a needle or injector) into the carrier in order to place a seed at a precise location in the carrier. The “Loader Patents” refers to U.S. Patent Application No. 13 / 460,809, filed April 30, 2012, now U.S. Patent No. 8,939,881 , entitled “Apparatus For Loading Dosimetrically Customizable Brachytherapy Carriers,” and U.S. Patent Application No. 14 / 696,293, filed April 24, 2015, entitled “Apparatus and Method for Loading Radioactive Seeds Into Carriers,” which are each hereby incorporated by reference in their entirety for all purposes, describe several embodiments of loaders. As discussed further herein, loaders may be operated manually, such as by human operators, or may be fully automated, such that carriers can be loaded with seeds using an automated process. Alternatively, loaders may be configured to be automated in part and require manual operation in part.

[0019] High Z Materials: any element with an atomic number greater than 20, or an alloy containing such materials.

[0020] Hot Carrier: a carrier that is loaded with a material that is radioactive.

[0021] Cold Carrier: a carrier that is not loaded with a material that is radioactive, such as a carrier prior to loading of a radioactive seed.

[0022] Shielding Material: any material that restricts movement of radiation emitted by radioactive particles, such as by absorbing, reflecting, and / or scattering radioactive emissions. Shielding may provide directionality of radiation delivery from the radioactive source. For example, a shielding layer may be configured to block radiation in certain directions without impacting radiation in other directions. The term “shielding,” as used herein, generally refers to any mechanism of preventing radiation from moving through and exiting a corresponding shielding material, such as by the shielding material absorbing, reflecting, or otherwise blocking the radiation. Shielding materials in various forms may be used in the various embodiments discussed herein. For example, a shielding material may be in the form of a particle, wire, rod, cylinder, bar, sheet, liquid, solution, foam, or any other form in which a material having radiation absorbing and / or reflecting properties is possible. A shielding material provides a shielding rate, which is generally an amount of shielding of radioactive energy (that is emitted from one or more radiation sources), provided by the particular shielding materials. Similarly, a shielding layer comprising multiple shielding materials and an isolation sheet have associated shielding rates, which are dependent on the combination of shielding (and possibly non-shielding) materials therein. For some applications, such as based on clinical need, an isolation sheet that provides a shielding rate of 25%, 50%, 75%, 90%, 95%, 98%, or some other shielding percentage, may be desired. As discussed herein, material composition, shape, size, dimensions, etc. may impact the shielding abilities of a shielding material. For applications (e.g., based on clinical need) where a higher shielding percentage is desired than may be provided by a single shielding material, multiple shielding materials may be used in combination, in one or more shielding layers or isolation sheets.

[0023] In some embodiments, shielding materials comprise high Z materials, such as tantalum, gold, platinum, tin, steel, copper, aluminum, etc. (e.g., a 0.01 mm to 0.06 mm thickness metallic foil). In other embodiments, any other material that reduces penetration of radiation may be a shielding material. For example, a non-metallic, yet dense compound, may be used alone (or in combination with a metallic material) as a shielding material. Such a non-metallic shielding material may advantageously lessen the chance of 1) MRI artifacts, 2) deflection of the isolation sheet, and / or 3) MRI-induced heating, such as may be caused by current loop induction and / or radio-frequency induced tissue heating that may be caused by metallic shielding materials. Depending on the particular non-metallic material, thickness of the material may be larger than a required thickness of a metallic shielding material, in view of the general enhanced shielding abilities of metallic materials. Non- metallic high density shielding materials may beneficially provide shielding of nontarget tissues from radiation particularly in applications where MRI or other magnetic field exposure may be anticipated. Examples of non-metallic shielding materials include polyetheretherketone (PEEK), nanoparticles, polymeric nanoparticles, encapsulated nanoparticles, calcium carbonate, calcium phosphate, calcium sulfate, barium sulfate, zirconium dioxide, polymers and polymer hybrids of these and other materials. Shielding materials may be combined to form a composite shielding material. For example, a metallic cylinder may be filled with (non-metallic) liquid calcium carbonate, in order to form a shielding material that better addresses one or more of the clinical needs of the patient than a separate metallic cylinder and liquid calcium carbonate or a solid metallic rod.

[0024] Any reference herein to a shielding material, even if the example references a particular metallic or non-metallic material (e.g., a particular form of a particular material), could be implemented with any other shielding material (e.g., a different form and / or different material) and / or combination of shielding materials. For example, a golden rod shielding material be replaced with a PEEK mesh shielding material that provides similar radiation absorption and / or reflecting properties. Dimensions (e.g., width, height, radius, thickness, etc.) of various shielding materials that provide the same radiation absorption and / or reflective properties may vary from one material to another.

[0025] Shielding Layer: one or more shielding materials configured for placement on or near radioactive sources (e.g., seeds) for reducing penetration of radiation outside of a treatment area. A shielding layer may comprise discrete layersof one or more materials, such as a gold foil sheet or a polymer sheet. In other embodiments, a shielding layer may include particles of high Z or non-metallic material that may be embedded within a shielding layer substrate (comprising a shielding layer material), such as a wrapper. In some embodiments, the shielding layer may be perforated or include a grid or mesh pattern, for example, interwoven with one or more high Z materials. A perforated or mesh shielding layer may improve effectiveness of the isolation sheet, for example, by configuring the shielding layer with desired radioactive shielding properties. A perforated or mesh shielding layer may also improve ease of handling (e.g., malleability that allows placement in the treatment area in the desired configuration) and / or imaging characteristics (e.g., reduces artifacts from shielding materials).

[0026] Wrapper: an apparatus configured for placement on or near, or attachment to, radioactive sources (e.g., seeds). A wrapper may include one or more shielding layers that is configured to shield (e.g., to block and / or absorb) a portion of the radiation emitted from the radioactive seed, such as from 5% - 95% of radiation.

[0027] In some embodiments, a wrapper may be configured for placement on or attachment to a carrier, without direct coupling to a radioactive seed. For example, a “carrier wrapper” may be placed and / or replaced on a surface of a carrier during a medical procedure, for example, by a medical professional to provide shielding from radiation from one or more radioactive seeds embedded in the carrier. In various implementations, a carrier wrapper may cover a portion of a carrier surface, all of a carrier surface, or multiple carrier surfaces. A carrier wrapper may secure to a carrier by adhesion, for example, by adhesive properties of the wrapper and / or carrier. A carrier wrapper may secure to a carrier by one or more fasteners of the wrapper configured to pierce the carrier to anchor the wrapper to the carrier. A carrier wrapper may be shaped to fit to a shape and / or size of a carrier. For example, a carrier wrapper configured for placement on a top surface of a tile carrier may be generally planar and sized to match the top surface size. In another example, a carrier wrapper configured for placement on a spherical surface of a carrier (e.g., a top surface of a spherical carrier) may be generally spherical with an inner cavity configured to receive thespherical surface of the carrier, such that the wrapper fits on or around the spherical surface.

[0028] A radioactive seed coupled to a wrapper is generally referred to as a “wrapped radioactive seed.” A radioactive seed may be attached to a wrapper via a friction fit and / or snap fit assembly. For example, a wrapper may be flexible enough to expand a diameter of the inner cavity to allow a radioactive seed to be inserted into the inner cavity. The seed in the cavity may then be held in place via a snap fit or friction fit between the wrapper and the radioactive seed. For example, a snap fit may be realized via one or more protrusions or other mechanical features at the edge of the wrapper that extend into the inner cavity. In general, the term “radioactive seed” or “seed” herein may refer to either a radioactive seed as described above and / or a wrapped radioactive seed.

[0029] A wrapped radioactive seed may be attached or embedded within a carrier for placement adjacent a treatment surface of a patient for delivery of radioactive therapy, or a wrapped radioactive seed may be placed directly on a treatment surface without attachment to a carrier.

[0030] Wrappers may comprise one or more materials such as plastics, polymers or other bio-compatible material, embedded with one or more shielding materials. Alternatively, a wrapper may be entirely composed of a shielding material. A wrapper may comprise a single continuous material or may comprise discrete layers of materials. In some embodiments, a wrapper may not include shielding material and may be used to hold a seed, for example, to facilitate loading a seed in a carrier. With a radioactive seed positioned within the cavity of a wrapper, radiation emitted from the seed is shielded in directions of the shielding material of the wrapper, while radiation may exit the seed and / or wrapper in directions that do not include a shielding material (e.g., the cavity opening of the wrapper) into patient tissue for adjuvant therapy.

[0031] Wrappers may be customized for a particular patient and / or treatment plan. For example, the opening of a wrapper may be adjusted to provide a reduced or increased area of radiation delivery from the wrapped radioactive seed.

[0032] Shielding Specifications (also referred to as a “Shielding plan”) attributes of one or more wrapped radioactive seeds, such as attributes of shieldinglayers and any other layers (e.g., collagen or other spacing layer, adhesive layers, etc.) included in the wrappers, such as any combination of those attributes (also referred to herein as “characteristics”) of wrapper shape, size, cavity dimensions, shielding material(s), shielding layer(s), and / or other aspects. Shielding specifications may be in digital form (e.g., in an electronic data structure, such as a database or table), written form (handwritten by an oncologist or surgeon or printed from a digital form), and / or may be developed and / or updated without (or prior to) placement of the wrapped radioactive seeds. Thus, shielding specifications may be developed in realtime based on clinical need and / or other patient characteristics.

[0033] Shielding specifications may be determined to best meet one or more of many clinical needs (and / or other shielding goals or requirements), such as to provide shielding that:• results in a directional therapeutic treatment area. Radiation sources, such as carriers embedded with radioactive seeds, generally emit radiation in an omnidirectional manner, such that all areas around the radiation sources absorb radiation (possibly in varying amounts depending on the shape, size, placement, etc. of the radiation source). Shielding specifications may include use of wrapped radioactive seeds that reduce the range of radiation by blocking radiation emitted in certain directions;• reduce risk of imaging distortion due to interference by the shielding materials (or other components);• reduce risk of RF heating caused by energy from MRI or other imaging devices, thereby reducing risk of further patient injuries, such as burning, as a result of imaging;• provide a preferred (or required in some embodiments) shape, size, etc., of wrappers, such as to allow placement of wrapped radioactive seeds in irregularly shaped treatment areas; and / or• reduce risk of deflection (e.g., movement) of shielding materials within the wrappers by energy from imaging devices, such as MRI.

[0034] Dosimetry: a process of measurement and quantitative description of the radiation absorbed dose (e.g., rad) in a tissue or organ.

[0035] Dosimetric Plan: a description of the prescribed dosimetry, such as for a particular patient, associated with a particular clinical condition, and / or for use in a particular surgical cavity, etc. For example, a dosimetric plan may indicate position, quantity, radioactive strength, etc., for placement of radioactive carriers on a treatment surface of a patient, such as in view of characteristics of a tumor removed (or planned for removal) from the patient. In some embodiments, dosimetric plans may include shielding specifications (or a “shielding plan), such as characteristics of one or more wrappers that are used in conjunction with radioactive seeds (e.g., as wrapped radioactive seeds) in accordance with the dosimetric plan. In other embodiments, the dosimetric plan for a patient may not include shielding specifications and, for example, may leave determination of the shielding specifications to another specialist, such as a surgeon that implements the dosimetric plan. Thus, the shielding specifications may be determined based on clinical need, even in real-time as or after some of the prescribed radioactive carriers are positioned on the treatment surface. Determining shielding specifications based on clinical need may better accommodate actual clinical condition of a patient that may be unknown and / or change after creation of a dosimetric plan, such as after removal of a tumor. In some embodiments, clinical need may be considered in order to increase shielding around sensitive tissue areas (e.g., an optic nerve, vital organs, etc.) or scar tissue areas. Any discussion herein of determining shielding specifications according to a dosimetric plan, which is one type of “treatment plan” specific to radiation therapy planning, refer additionally to determination of those same shielding specifications according to clinical need, such that shielding specifications may be determined based on a dosimetric plan and / or clinical need.

[0036] Therapeutic Index: relationship between an amount of therapeutic effect provided by a therapeutic agent, such as one or more radioactive seeds in carriers, to an amount that causes toxicity. The therapeutic index may indicate a relative amount of healthy tissue (non-target tissue) receiving radiation (e.g., above a certain dosage level) compared to an amount of the target area (e.g., a tumor or tumor bed) receiving radiation. The therapeutic index may be a ratio of radiation delivered to a treatment area (e.g., tumor or tumor bed) to radiation delivered to areassurrounding the treatment area. Thus, a higher therapeutic index generally indicates better localization of radiation to the treatment area, sparing as much of the surrounding area from radiation as possible. Accordingly, improving the therapeutic index may increase local control of tumors and / or decrease the morbidity of treatment.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The following drawings and the associated descriptions are provided to illustrate embodiments of the present disclosure and do not limit the scope of the claims. Aspects and many of the attendant advantages of this disclosure will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

[0038] Figures 1A and 1 B are cross-sectional drawings illustrating portions of patient tissue having tumor beds therein, respectively.

[0039] Figure 1 C illustrates an example where a tumor cavity is not present and, thus, the carriers are placed on a substantially planar treatment area of tissue, such as a patient's skin covering the skull or other tissue.

[0040] Figure 2 is a perspective view of an example embodiment of a "button" wrapper.

[0041] Figure 3 illustrates further details of the example button wrapper, from a bottom perspective view of the wrapper.

[0042] Figures 4A- 4D are exploded views of components of an example loaded carrier that is shown in the perspective view of Figure 4E.

[0043] Figure 4E illustrates a loaded carrier with the four wrappers contacting the top surface of the carrier to hold in place the four corresponding radioactive seeds at least partially embedded within the carrier.

[0044] Figure 5 is a perspective view of two example strip wrappers attached to a carrier.

[0045] Figures 6A-6D are exploded views of components of an example loaded carrier that is shown in the perspective view of Figure 6E.

[0046] Figure 6E illustrates a loaded carrier with the two strip wrappers contacting the top surface of the carrier.

[0047] Figure 7A illustrates a top and cross-section views of a U-shaped wrapper (also referred to herein as U-wrapper).

[0048] Figures 7B - 7F are top views of alternative embodiments of a U- wrapper, each including different stabilization and / or attachment mechanisms that are configured to maintain position of the wrapper with reference to a carrier.

[0049] Figure 8 illustrates an example shielded U-wrapper with a seed at least partially enclosed in the elongated slots.

[0050] Figures 9A-9D illustrate alternative configurations and dimensions of elongated slots within insertions arms.

[0051] Figure 10 illustrates a carrier having an attached U-wrapper.

[0052] Figure 11 illustrates an alternative elongated slot, which generally is deeper into the insertion arms, than those in Figure 10.

[0053] Figure 12 illustrates several views of an example carrier with two U- wrappers.Example Carrier Embodiments

[0054] Figures 1A and 1 B are cross-sectional drawings illustrating a portion of patient tissue 102 and 112 having tumor beds 104 and 114 therein, respectively. These tumor beds 104 and 114 may have been created by a surgical process, such as a tumor debulking process that removed tumor cells. For example, the tissue 102 or 112 may represent cranial tissue of a human (or other mammal) wherein the tumor beds 104 and 114 are surgically created in order to remove one or more tumors from the brain (and / or surrounding areas) of the patient. Thus, the tissue 102 and 112 may represent different types of material, such as bone, fatty tissue, brain tissue, etc. Any reference herein to “tissue” may reference to any type of mammalian material, including bone, fatty tissue, brain tissue, etc.

[0055] In the example of Figure 1A, four tile carriers 106 are illustrated as already placed within the tumor bed 104. Placement of the tiles 106 in the tumor bed 104 may occur in the surgical room, such as immediately after a surgical procedure,or elsewhere at some time after the surgical procedure, such as in a separate procedure performed hours, days, or weeks later. In the embodiment of Figure 1 A, the tiles 106 are pliable such that they conform to the treatment surface, which is the non-planar outer surface of the tumor bed 104 in this example. In one embodiment, the tiles 106 may comprise collagen that provides such flexibility in conforming the tiles 106 to a nonplanar surface. In the example of Figure 1 B, tiles 116 that are placed in tumor bed 114 of tissue 112 are comprised of a non-pliable substrate, such as a polymer, that maintains its substantially planar shape even when placed within the tumor bed 114. For ease of discussion, tile carriers discussed herein are illustrated as being flexible, such as the tiles 106 in Figure 1A. However, any other type of tile carrier, as well as other configurations of carriers, such as gore, star, or dot carriers, may be used alternatively. Thus, any discussion herein of a tile carrier or any other particular carrier should be interpreted to also include embodiments using other types of carriers, no carriers at all (e.g., radioactive seeds could be placed in a tumor bed without first being placed in a carrier), and / or any other radiation delivery device.

[0056] In the examples of Figure 1A and 1 B, the tiles 106 and 116 each include a radioactive seed embedded therein. As discussed in the related patents and patent applications noted above, the radioactive seeds can have various shapes, sizes, and characteristics. In the examples discussed herein, radioactive seeds are illustrated as generally cylindrical, such as the cylinders included in each of the tiles 106 and 116 of Figures 1A and 1 B. However, other shapes and sizes of seeds may be used in other implementations. In the examples discussed herein, radioactive seeds are substantially rigid, such that they maintain their shape within their respective carriers. Thus, as shown in Figure 1A, even when the carriers 106 near the bottom of the tumor bed 104 are deformed to better engage with the treatment surface, the seeds therein retain their linear cylindrical shape. In other embodiments, seeds may be more pliable, such that they are somewhat malleable in taking on a shape of a specific treatment surface. In the example of Figure 1C, a tumor cavity is not present and, thus, the carriers 126 are placed on a substantially planar treatment area of tissue 122, such as a patient’s skin covering the skull or other tissue.

[0057] In the examples of Figure 1A, 1 B, and 1 e radiation is delivered to the corresponding treatment area by the radioactive seeds within the carriers 106, 116, and 126, respectively. However, radiation from these seeds may also extend to other areas of tissue that are outside of the desired treatment area. For example, radiation emitted from top surfaces of the carriers may extend to surrounding tissue outside of the treatment area, other portions of tissue that come near and / or contact the treatment surface (e.g., the hand of a patient placed over the tumor bed 104), or even tissue of another person or animal, such as a spouse that lays near the treatment surface and, thus, receives radiation from the radioactive seeds. Accordingly, depending on placement of the carriers, size and shape of treatment surface, radioactive seed intensity, and / or many other factors, the therapeutic index for use of such carriers may be unnecessarily low. Discussed herein are various shielding devices, systems, and methods, which are generally designed to improve therapeutic index for delivery of radiation using brachytherapy.Example Wrapper Embodiments

[0058] Disclosed herein are several embodiments of wrappers, which are generally any materials that are placed over, around and / or that are included with radioactive seeds in order to provide directional radioactive shielding. As noted above, a wrapper may include a single shielding layer, which itself may include one or more shielding materials, or multiple shielding layers in various positional relationships to one another. Wrappers may improve a therapeutic index associated with a dosimetry plan. Shielding materials used in wrappers may include, for example, high-z materials or alloys thereof, in various forms, formed in shielding layers such as a foil, mesh, oriented strips, grid, embedded, sprayed, bio-adhered, or an on-lay in or on a substrate, such as one or more layers of plastic or polymer. While specific shapes, material compositions, properties, etc. are disclosed herein with reference to various example wrappers, variations on these examples are anticipated. Examples of wrappers are shown and described in U.S. Application No. 17 / 936,149, titled “RADIATION SHIELDING APPARATUS FOR IMPLANTABLE RADIOACTIVE SEEDS,” filed September 28, 2022, which is hereby incorporated by reference in its entirety. Any enhancements, modifications, additions, etc. discussed in thatapplication may also be used in conjunction with the wrappers discussed herein, even if not specifically discussed herein.

[0059] The wrappers discussed herein may provide one or more of the technical advantages below:• Holds a shielded seed• Can be imaged on CT• Has negligible impact on MRI• Shield / seed complex introduction into tile is reproducible and reasonably stable (e.g., rotationally)• Impact on dosimetric plan can be determined with ~current TPS abilities• Uses current collagen form factor• Uses materials already in use intracranially• Has similar tile conformability• Ability to cut into 14 if neededExample Button Wrapper Embodiments

[0060] Figure 2 is a perspective view of an example embodiment of a “button” wrapper 302. In the example of Figure 2, four radioactive seeds (not shown) are partially embedded in the carrier 304 and held in place by respective button wrappers 302, making the carrier 304 a “loaded” carrier (to signify that the carrier includes one or more radioactive sources). In this example, each of the button wrappers 302 includes a substantially circular base 303 having a cylindrical protrusion 308 extending outward. As used herein, the terms “embedded” and “partially embedded” may refer to any level of embedding (e.g., the radioactive seed is embedded from 1 -100 percent within the carrier), as well as abutting of the components (e.g., the radioactive seed abuts, or is on top of, the carrier).

[0061] Figure 3 illustrates further details of the example button wrapper 302, from a bottom perspective view of the wrapper 302. In this example, the bottom side of that cylindrical protrusion 308 (Figure 2) is shown as a cylindrical elongated slot 309. The elongated slot 309 is sized to receive a radioactive seed, such as a cylindrical radioactive seed. With the radioactive seed partially embedded in the buttonwrapper 302 (e.g., in the cylindrical elongated slot 309) and partially embedded in the carrier 304 (or, as noted above, atop the carrier 304), the radioactive seed is held into place in (or on) the carrier 304. In this example, the button wrappers 302 each include attachment apertures 306 configured to receive an attachment mechanism that secures the button wrapper 302 to the carrier 304, with the radioactive seed partially within the elongated slot 309 and partially embedded in (or on) the carrier 304. In some implementations, a suture may be inserted through a first of the apertures 306, through the carrier 304, then back through the backside of the carrier 304 and the other aperture 306 before tying off the suture tightly to maintain contact of the wrapper 302 on a top surface of the carrier 304. In other embodiments, other attachment mechanisms may be used, such as a barbed anchor, a spike, hook, etc. that may be inserted through one or more of the apertures 306 or on edges of the base 303. In some embodiments, the bottom surface of the base 303 adheres well enough to the top surface of the carrier 304 so that additional attachment mechanisms are not needed. In some embodiments, an adhesive may be used to adhere the button wrapper 302 to the carrier 304.

[0062] The example of Figure 3 provides a bottom view 350, a side cross- sectional view 360, and a side view 370 of the example button wrapper 302. In other embodiments, the dimensions of the wrapper 302 components may vary.

[0063] Figures 4A- 4D are exploded views of components of an example loaded carrier 404E that is shown in the perspective view of Figure 4E. In this example, the loaded carrier 404E includes four radioactive seeds that are held in place with four button wrappers 402, with shielding layers (or “shieldings”) 403 between the radioactive seeds 430 and wrappers 402 providing directional shielding.

[0064] Starting with Figure 4A, four button wrappers 402 are shown above four shieldings 403 and four radioactive seeds 430. While the shieldings 403 are shown separate from the wrappers 402, in some embodiments the shieldings 403 are adhered to the elongated slots of the wrappers 402 and / or integral to the wrappers 402 (e.g., a shielding layer may be part of the wrapper base).

[0065] Moving to Figure 4B, the radioactive seeds 430 are shown partially embedded in the carrier 404. In some embodiments, the radioactive seeds arepositioned within the elongated slots of the button wrappers 402 prior to embedding in (or placement on top of) the carrier 404. For example, a wrapper 402 with a shielding403 in an elongated slot may receive a radioactive seed that is held in place via a snap or friction fit or adhesive. The loaded wrapper 402 (e.g., the wrapper including a radioactive seed) may then be pressed onto the top (or bottom) surface of the carrier404 to at least partially embedded (or position on top of) the radioactive seed into the carrier 404.

[0066] Moving to Figure 4C, the shieldings 403 are shown atop the radioactive seeds 430 that are partially embedded in the carrier 404. As such, the shieldings 403 reduces radiation that otherwise would be released upward from the radioactive seeds, while not impacting radiation directed downward into the carrier 404 and, presumably, towards a treatment area of a patient. Thus, the shieldings 403 provide directionality of radiation delivery, such as may increase the therapeutic index of a treatment plan.

[0067] Figure 4D shows the button wrappers 402 just about the top surface of the carrier 404, and the corresponding encasement of the radioactive seeds 430 and shielding 403 within the elongated slot of the button wrappers 402.

[0068] Figure 4E illustrates a loaded carrier 404E with the four wrappers 402 contacting the top surface of the carrier 404E to hold in place the four corresponding radioactive seeds at least partially embedded within the carrier 404E, while also applying shielding via the shielding 403 in a directional manner to increase a therapeutic index of the loaded carrier 404E.

[0069] In other embodiments, different quantities of button wrappers 402 may be used for a single carrier 404. Additionally, other shapes and sizes of carriers may be used in conjunction with button wrappers 402. Additionally, in some embodiments shielding 403 may be integral to the button wrappers 402 and / or may not be added - for example, the button wrappers 402 may be placed directly on the radioactive seeds 430.Example Strip Wrapper Embodiments

[0070] Figure 5 is a perspective view of two example strip wrappers 510 attached to a carrier 504. In this example, the strip wrappers 510 each include twocylindrical protrusions 508 that correspond to cylindrical elongated slots (not shown) on the bottom side of the strip wrappers 510. The elongated slots are each sized to receive a radioactive seed, such as a cylindrical radioactive seed. With a radioactive seed partially in one or both of the cylindrical elongated slots, the strip wrapper 510 may be attached to the carrier 504 to hold the radioactive seeds in position within and / or on a surface of the carrier 504. In this example, a base 501 of the strip wrapper 510 has a length that is substantially the same as a length of the carrier 504, such that flanges 507 that are on either end of the wrapper 510 contact and / or are very close to sides of the carrier 504. In some implementations, the flanges 507 are positioned so that they create a friction fit with the carrier 504 and hold the wrapper 510 in place on the carrier 504. In some implementations, an angle between the flanges 507 may be slightly less than 90°, so that a lower surface of the flanges 507 partially embeds within sides of the carrier 504.

[0071] In the example of Figure 5, the flanges 507 each include an attachment aperture 506 configured to receive an attachment mechanism, such as a suture, barbed anchor, hook, etc. In some implementations, a suture is extended through the aperture 506 of a first flange, through the length of the carrier 504, and out the aperture 506 on the other flange. The suture may be tied off on each end separately or the ends may be tied together to attach to the carrier 504 and maintain position of the radioactive seeds within the carrier 504.

[0072] In the example of Figure 5, two strip wrappers 510 are shown attached to a carrier 504 so that four radioactive seeds are partially embedded within the carrier 504 (or atop the carrier 504 in some implementations). In other embodiments, a strip wrapper may include a different quantity of elongated slots, such as one, three, four, etc. Additionally, fewer or additional strip wrappers may be attached to a single carrier 504. For example, a third strip wrapper 510, housing two additional radioactive seeds, may be positioned between the strip wrappers 510 shown in Figure 5 to create a loaded carrier 504 with six radioactive seeds.

[0073] Figures 6A-6D are exploded views of components of an example loaded carrier 504E that is shown in the perspective view of Figure 6E. In this example, the loaded carrier 504E includes four radioactive seeds that are held in placewith two strip wrappers 510 that each partially encase two radioactive seeds and provide direction shielding via shieldings 503.

[0074] Starting with Figure 6A, two strip wrappers 510A and 51 OB are shown above four shieldings 503 and four radioactive seeds 530. While the shieldings 503 are shown separate from the wrappers 510, in some embodiments the shieldings503 are adhered to the cylindrical slots of the wrappers 510 and / or integral to the wrappers 510 (e.g. , a shielding layer may be part of the wrapper base).

[0075] Moving to Figure 6B, the radioactive seeds 530 are shown partially embedded in the carrier 504. In some embodiments, the radioactive seeds 530 are positioned within the cylindrical slots of the strip wrappers 510 prior to embedding in (or placing on top of) the carrier 504. For example, the strip wrapper 510B with a shielding 503 in each of the two elongated slots (on the bottom of the wrapper 510B, not shown in Figure 6) may receive two radioactive seeds that are held in place via a snap or friction fit or adhesive. The loaded wrappers 510 (e.g., the wrapper including one or more radioactive seed) may then be pressed onto the top surface of the carrier504 to at least partially embedded the radioactive seeds into the carrier 504.

[0076] Moving to Figure 6C, the shieldings 503 are s shown atop the radioactive seeds 530 (not visible in Figure 6C) that are at least partially embedded in the carrier 504. As such, the shieldings 503 reduce radiation that otherwise would be released upward from the radioactive seeds, and concentrates radiation directed downward into the carrier 504 and, presumably, towards a treatment area of a patient.

[0077] Figure 6D shows the strip wrappers 510 just above the top surface of the carrier 504, and the corresponding encasement of the radioactive seeds 530 and shielding 503 within the elongated slot of the wrappers 510.

[0078] Figure 6E illustrates a loaded carrier 504E with the two strip wrappers 510A and 510B contacting the top surface of the carrier 504E to hold in place the four corresponding radioactive seeds at least partially embedded within the carrier 504E, while also applying shielding via the shieldings 503 in a directional manner to increase a therapeutic index of the loaded carrier 504E.Example U-Wrapper Embodiments

[0079] Figure 7A illustrates a top and cross-section views of a U-shaped wrapper 610 (also referred to herein as U-wrapper). The example U-wrapper 610 may be configured to attach to a top or bottom surface of a carrier or, in some embodiments, may be configured for insertion into a side of a carrier. The top view of the U-wrapper in Figure 7A includes two insertion arms 612 that are connected via a connecting arm 611. In this embodiment, the connecting arm 611 is rigid enough to maintain a substantially parallel orientation of the insertion arms 612. The insertion arms and connecting arm may be a single structure, such as may be manufactured via injection molding, or may be multiple components that are coupled together.

[0080] In some implementations of U-wrappers, such as in Figures 7A-12, the insertion arms 612 may be supported by and releasably coupled to the connecting arm 611 , such that upon placement of the insertion arms 612, loaded with seeds, to a desired location and orientation within a carrier, the connecting arm 612 may be selectively decoupled (e.g., removed) from the insertion arms. This decoupling of the connecting arm 611 from the insertion arms 612 leaves the seeds 614 positioned within the carrier in the insertion arms, without the connecting arm 611 extending from a side of the carrier. In some embodiments, the connecting arm 611 may be reusable, such as by attaching the connecting arm 611 to additional insertion arms 612 for insertion into the same or another carrier. In some implementations, after insertion of the insertion arms 612 into a carrier, the insertion arms 612 may be severed (e.g., cut) from the connecting arm 611 , such that the insertion arms 612, loaded with seeds, remain embedded within the carrier.

[0081] In the example of Figure 7A, an elongated slot 614 is shown in each of the insertion arms 612. As seen in the side cross-section, each of the elongated slots 614 comprises a generally hemi-cylindrical cutout of the corresponding insertion arm 612. Advantageously, the elongated slots 614 are sized to receive a radioactive seed and maintain position of the radioactive seed with reference to a carrier (not shown in Figure 7A) when the U-wrapper 610 is attached to the carrier. In this example, the insertion arms 612 each include a piercing tip 616 configured to allow insertion of the insertion arms into the carrier, such as into a side of the carrier, withoutrequiring a predrilled channel or without potentially destroying part of the carrier which may occur if a blunt end is forced into the carrier.

[0082] Figures 7B - 7F are top views of alternative embodiments of a U- wrapper 610, each including different stabilization and / or attachment mechanisms that are configured to maintain position of the wrapper with reference to a carrier. Any combination of the features illustrated in these figures may be used with reference to other embodiments of the U-wrappers disclosed herein, such as in Figures 8 - 11. Additionally, attachment and stabilization mechanisms such as those discussed in Figures 7B - 7F may be used in conjunction with other types of wrappers, such as the button wrappers or strip wrappers that are discussed above.

[0083] The U-wrapper 610B in Figure 7B includes a piercing tip 616B that extends beyond the width of the insertion arms 612, which provides a hook within the carrier that increases stability of the U-wrapper 610B within a carrier (e.g., a collagen substrate) by increasing difficulty of pulling the U-wrapper 610B back out of the carrier once inserted.

[0084] The U-wrapper 610C in Figure 7C includes barbed tips 619 on the connecting arm 611 , positioned so that when the U-wrapper 610C is inserted into a carrier the barbed tips 619 enter the side of the carrier and lock the U-wrapper 620C in place (with the connecting arm 611 flush with the side of the carrier.

[0085] The U-wrapper 610D includes a connecting arm 611 with elongated portions 620 that extend beyond the junction of the connecting arm 611 with the insertion arms. These elongated portions 620 may contact a side of the carrier when the insertion arms 612 are inserted into the side of the carrier. The elongated portions provide rotational stability of the U-wrapper 610D with references to the carrier.

[0086] The U-wrapper 610E in Figure 7E includes barbed tips 621 on the elongated portions 620 of the connecting arm 611 , positioned so that when the U- wrapper 610E is inserted into a carrier the barbed tips 621 enter the side of the carrier and lock the U-wrapper 620E in place (with the connecting arm 611 flush with the side of the carrier.

[0087] The U-wrapper 61 OF in Figure 7F includes a combination of stabilization and attachment mechanisms discussed above with reference to Figures7B-7E. In particular, the U-wrapper 61 OF includes piercing tips 616B that extends beyond the width of the insertion arms 612, which provides a hook within the carrier that increases stability of the U-wrapper 61 OF within a carrier. The U-wrapper 61 OF further includes elongated portions 620 of the connecting arm 611 and barbed tips 621 on each of the connecting arms. The U-wrapper 61 OF future includes barbed tips 619 on the connecting arm 611 between the insertion arms 612.

[0088] In other embodiments, any combination of these attachment and stabilization mechanisms may be used with a wrapper.

[0089] Moving to Figure 8, the U-wrapper 610 with a shielding 615 is shown with a seed 630 at least partially enclosed in the elongated slots 614. In some embodiments, the shielding 615 may be placed in the elongated slots 614 prior to insertion of the radioactive seeds 630. For example, a shielding layer may be adhered to the elongated slots 614 prior to shipment to the use location (e.g., a hospital or surgery center). In some embodiments, the radioactive seeds 630 are also loaded into the elongated slots and are maintained in position within the elongated slots via snap fit, friction fit, adhesive, and / or other means, prior to delivery to the use location. In other implementations, the components may be assembled at the use location prior to insertion into a carrier.

[0090] Figures 9A-9D illustrate alternative configurations and dimensions of elongated slots 914 within insertions arms. Any of the configurations of Figures 9A- 9D may be used with any other configuration of U-wrapper and / or other wrapper (e.g. , such as the U-wrapper 610 of Figures 7-11 ). In some embodiments, the shielding 925A-925D is shown extending about halfway around the radioactive seeds 930 (e.g., 180 degrees around the seed). However, any of these embodiments may be modified to provide a different directionality of the radiation treatment by adjusting the shielding 925 to cover less (e.g., only 15 degrees) or more (e.g., 145 degrees) of the radioactive seeds.

[0091] Figure 9A illustrates elongated slots 914A that are generally deeper into the insertion arms than in the example of Figure 8. In this example, the elongated slots 914A allow embedding of more than half of the radioactive seeds 930 into the insertion arms. In this embodiment, the radioactive seeds 930 may better maintainposition within the elongated slots of the insertion arms, such as when the wrapper is inserted into a carrier.

[0092] Figure 9B illustrates elongated slots 914B that are even deeper into the insertion arms than in the example of Figure 9A. In this example, the elongated slots 914B allow embedding of the entire radioactive seeds 930 into the insertion arms. In this embodiment, the radioactive seeds 930 may better maintain position within the elongated slots of the insertion arms, such as when the wrapper is inserted into a carrier.

[0093] Figure 9C illustrates elongated slots 914C that are deep enough into the insertion arms to allow embedding of the entire radioactive seeds 930 into the insertion arms. Additionally, the elongated slots 914C include a narrowed opening, which may provide a snap-fit engagement of the seeds 930 withing the elongated slots 914C. In this embodiment, the radioactive seeds 930 may better maintain position within the elongated slots of the insertion arms, such as when the wrapper is inserted into a carrier.

[0094] Figure 9D illustrates elongated slots 914D that are covered top and bottom by the insertion arm. In this example, the radioactive seeds may be slid in through an end of the insertion arms, such as prior to attaching the piercing tip 616 to insertion ends of the insertion arms. In this embodiment, the radioactive seeds 930 may better maintain position within the elongated slots of the insertion arms, such as when the wrapper is inserted into a carrier.

[0095] Figure 10 illustrates a carrier 1004 having an attached U-wrapper 610. In this example, the U-wrapper 610 has been inserted into a side of the carrier 1004 so that the connecting arm 611 abuts a side of the carrier 1004. In this example, the radioactive seeds 630 are maintained in position within the carrier 1004 and, additionally, the shielding 615 provides directional shielding of radiation from the radioactive seeds.

[0096] Figure 11 illustrates an alternative elongated slot 915, which generally is deeper into the insertion arms, than those in Figure 10. In the example of Figure 11 , the elongated slots 915 allow embedding of more than half of the radioactive seeds 630 into the insertion arms. In this embodiment, the radioactiveseeds 630 may better maintain position within the elongated slots of the insertion arms.

[0097] Figure 12 illustrates several views of carrier 1230 with two U- wrappers 1210. In this example, the U-wrappers 1210 include generally narrower insertion arms 1212 with a seed-carrying portion 1225 expanded to provide an elongated slot sized to fit a radioactive seed. Attachment prongs 1216 are also included at the insertion ends of the insertion arms 1212. In this embodiment, the narrower insertion arm next to the prongs 1216 allow for better attachment within the carrier, such as by allowing the carrier material (e.g., collagen) to fill the area behind the prongs 1216 to hold the prongs 1216 and the entire U-wrapper 1210 in place. In the embodiment of Figure 12, the insertion arms have generally rounded edges, as can be seen in the perspective view. For example, the insertion arms 1212 may be cylindrical.

[0098] In the example of Figure 12, a first U-wrapper 1210A is shown outside of the carrier 1230, ready for insertion into a side 1231 of the carrier and a second U-wrapper 1210B that has already been inserted through the side 1232 of the carrier 1230 such that the radioactive seeds within the extension arms are embedded in the carrier 1230. In this example, the U-wrapper 1210B is shown fully attached to the carrier 1230, with the connecting arm 1211 flush with the side 1232 of the carrier 1230. As noted elsewhere, the example U-wrapper in Figure 12 may include fewer or additional attachment and / or stabilization mechanisms, such as those discussed with reference to Figures 7B-7F.

[0099] In some embodiments, a loaded carrier may be created using two of the U-wrappers illustrated in Figures 7 - 11. For example, a first U-wrapper may be inserted into a first side of the carrier (e.g., a side or end of a square or rectangular carrier) and a second U-wrapper may be inserted into a second side of the carrier, so that four radioactive seeds are embedded in the carrier.

[0100] In some embodiments, a U-shaped wrapper may include fewer or additional elongated slots for receiving radioactive seeds. In some embodiments, the piercing tip 616 may include an anchoring mechanism, such as a hook, ribbed edges,and / or other means for more securely maintaining position of the insertion arms 612 in the carrier.

[0101] In some implementations, the insertion arms 1212 may be supported and releasably coupled to the connecting arm 1211 , such that upon placement of the insertion arms 1212, including the seed-carrying portions 1225, to a desired location and orientation within a carrier, the connecting arm 1212 may be selectively decoupled (e.g., removed) from the insertion arms. This decoupling of the connecting arm 1211 from the insertion arms 1212 leaves the seed-carrying portions 1225 positioned within the carrier, without the connecting arm 1211 extending from a side of the carrier 1230. In some embodiments, the connecting arm 1211 may be reusable, such as by attaching the connecting arm 1211 to additional insertion arms 1212 for insertion into the same or another carrier. In some implementations, after insertion of the insertion arms 1212 into a carrier, the insertion arms 1212 may be severed (e.g., cut) from the connecting arm 1211 , such that the insertion arms 1212, including the seed-carrying portions 1225, remain embedded within the carrier 1230.Example specifications

[0102] The below are example specifications of components discussed above with reference to the various wrapper embodiments. These are provided as examples only, and other specifications are contemplated.• Radioactive seed 0.85 x 4.5 mm• Collagen carrier: 1 -6 mm x 20 mm x 20 mm (e.g., 4 mm for U-wrapper and 3 mm for button and strip wrappers)• Shielding: likely less than 1 mm, such as 0.04 mm thick for gold foil o wrapping 90-270 degrees around seed in elongated slot• Carriers are flexible and may be cut, such as into halves, each with one or more button, strip, and / or U-wrappers.• ATARA (as thin as reasonably achievable)Example Clauses

[0103] Examples of the implementations of the present disclosure can be described in view of the following example clauses (and the example clauses providedabove). The features recited in the below example implementations can be combined with additional features disclosed herein. Furthermore, additional inventive combinations of features are disclosed herein, which are not specifically recited in the below example implementations, and which do not include the same features as the specific implementations below. For sake of brevity, the below example implementations do not identify every inventive aspect of this disclosure. The below example implementations are not intended to identify key features or essential features of any subject matter described herein. Any of the example clauses below, or any features of the example clauses, can be combined with any one or more other example clauses, or features of the example clauses or other features of the present disclosure.

[0104] Clause 1. A carrier system for delivering directional radiation treatment to a tissue site according to a dosimetric plan, the carrier system comprising: a biocompatible carrier configured to be placed on an exposed treatment surface of a surgically-created cavity in mammalian tissue; and a [button] wrapper comprising a base and a central elongated slot extending substantially across a width of the wrapper, wherein the central elongated slot is sized to receive at least a portion of a radioactive seed, and wherein the wrapper is configured to receive a radioactive seed withing the central elongated slot and placed on the biocompatible carrier such that a bottom surface of the base contacts the biocompatible carrier and holds the radioactive seed in place between the wrapper and the biocompatible carrier.

[0105] Clause 2. The carrier system of clause 1 , wherein the radioactive seed is atop the biocompatible carrier.

[0106] Clause 3. The carrier system of clause 1 , wherein the radioactive seed is at least partially embedded in the biocompatible carrier.

[0107] Clause 4. The carrier system of clause 1 , wherein the wrapper further comprises at least two apertures through the base configured to receive an anchoring medium to better hold the bottom surface of the base on the biocompatible carrier and, correspondingly, better hold the radioactive seed in place.

[0108] Clause 5. The carrier system of clause 4, wherein the anchoring medium comprises a suture that is inserted via a needle.

[0109] Clause 6. The carrier system of clause 4, wherein the anchoring medium comprises a fastener, anchor, staple, screw, or other structure configured to lock into place within the biocompatible carrier.

[0110] Clause 7. The carrier system of clause 1 , wherein the base is substantially, oval, circular, rectangular, or square.

[0111] Clause 8. The carrier system of clause 1 , further comprising: a high- z shielding layer positioned in the central elongated slot between the base and the radioactive seed.

[0112] Clause 9. The carrier system of clause 1 , wherein the elongated slot comprises a semicircular cylindrical cavity.

[0113] Clause 10. A [button] wrapper comprising: a base; a central elongated slot extending substantially across a width of the base; a high-z shielding layer positioned in the central elongated slot; wherein the central elongated slot with the high-z shielding layer is sized to receive a radioactive seed.

[0114] Clause 11. The wrapper of clause 10, wherein the wrapper is configured to be positioned on a top surface of a biocompatible carrier such that a bottom surface of the base contacts the biocompatible carrier and holds the radioactive seed in place between the wrapper and the biocompatible carrier.

[0115] Clause 12. The wrapper of clause 11 , wherein the radioactive seed is atop the biocompatible carrier.

[0116] Clause 13. The wrapper of clause 11 , wherein the radioactive seed is at least partially embedded in the biocompatible carrier.

[0117] Clause 14. A carrier system for delivering directional radiation treatment to a tissue site according to a dosimetric plan, the carrier system comprising: a biocompatible carrier configured to be placed on an exposed treatment surface of a surgically-created cavity in mammalian tissue; a [strip] wrapper comprising: a substantially rectangular base having a length substantially the same as a length of the biocompatible carrier; the base including flanges at either end at a substantially right angle; the base including an elongated slot sized to receive at least a portion of a radioactive seed; wherein the wrapper, with a radioactive seed positioned at least partially within the elongated slot, is configured for placement on the biocompatiblecarrier such that a bottom surface of the base contacts the biocompatible carrier and the radioactive seed is held in place between the wrapper and the biocompatible carrier.

[0118] Clause 15. The carrier system of clause 14, wherein the radioactive seed is atop the biocompatible carrier.

[0119] Clause 16. The wrapper of clause 14, wherein the radioactive seed is at least partially embedded in the biocompatible carrier.

[0120] Clause 17. The carrier system of clause 14, wherein the base further comprises a second elongated slot sized to receive a second radioactive seed; and wherein the wrapper, with the second radioactive seed positioned at least partially within the second elongated slot and at least partially embedded in the biocompatible carrier, is held in place by the wrapper.

[0121] Clause 18. The carrier system of clause 14, wherein the wrapper further comprises a first aperture through a first flange on a first end of the base and a second aperture through a second flange on a second end of the base, the apertures configured to receive an anchoring medium to better hold the bottom surface of the base on the biocompatible carrier and, correspondingly, better hold the radioactive seed in place.

[0122] Clause 19. The carrier system of clause 18, wherein the anchoring medium comprises a suture that is inserted via a needle.

[0123] Clause 20. The carrier system of clause 19, wherein the suture extends through a width of the biocompatible carrier.

[0124] Clause 21. The carrier system of clause 18, wherein the anchoring medium comprises a fastener, anchor, staple, screw, or other structure configured to lock into place within the biocompatible carrier.

[0125] Clause 22. The carrier system of clause 14, further comprising: a high-z shielding layer positioned in the central elongated slot between the base and the radioactive seed.

[0126] Clause 23. The carrier system of clause 22, wherein the shielding layer is adhered or integral to the elongated slot.

[0127] Clause 24. A [strip] wrapper comprising: a substantially rectangular base including: flanges at either end at a substantially right angle; an elongated slot sized to receive at least a portion of a radioactive seed; a high-z shielding layer positioned in the central elongated slot between; wherein the central elongated slot with the high-z shielding layer is sized to receive a radioactive seed.

[0128] Clause 25. The wrapper of clause 24, wherein the wrapper is configured to be positioned on a top surface of a biocompatible carrier such that a bottom surface of the base contacts the biocompatible carrier and holds the radioactive seed in place between the wrapper and the biocompatible carrier.

[0129] Clause 26. The wrapper of clause 25, wherein the radioactive seed is atop the biocompatible carrier.

[0130] Clause 27. The wrapper of clause 25, wherein the radioactive seed is at least partially embedded in the biocompatible carrier.

[0131] Clause 28. A carrier system for delivering directional radiation treatment to a tissue site according to a dosimetric plan, the carrier system comprising: a biocompatible carrier configured to be placed on an exposed treatment surface of a surgically-created cavity in mammalian tissue; a [U] wrapper comprising: a substantially U-shaped base having a first insertion arm and a second insertion arm that are held in a substantially parallel relationship by a connecting arm therebetween, wherein the first insertion arm includes a first elongated slot sized to receive at least a portion of a first radioactive seed and the second insertion arm includes a second elongated slot sized to receive at least a portion of a second radioactive seed; wherein the wrapper, with the first radioactive seed positioned at least partially within the first elongated slot of the first insertion arm and the second radioactive seed positioned at least partially within the second elongated slot of the second insertion arm, is configured for attachment to the biocompatible carrier by insertion of the insertion arms into a side of the biocompatible carrier until the radioactive seeds are at least partially embedded within the biocompatible carrier.

[0132] Clause 29. The carrier system of clause 28, wherein the radioactive seeds are sufficiently inserted into the biocompatible carrier when the connecting arm contacts the side of the biocompatible material.

[0133] Clause 30. The carrier system of clause 28, wherein the connecting arm is removably attachable to the first and second insertion arms.

[0134] Clause 31 . The carrier system of clause 30, wherein the connecting arm is removed from the first and second insertion arms prior to placement of the biocompatible carrier on the exposed treatment surface of the surgically-created cavity.

[0135] Clause 32. The carrier system of clause 28, wherein the connecting arm is configured to be cut from the first and second insertion arms prior to placement of the biocompatible carrier on the exposed treatment surface of the surgically-created cavity. 33.

[0136] Clause 34. The carrier system of clause 28, wherein the first elongated slot is sized to receive at least half of the first radioactive seed such that less than half of the radioactive seed is above a top surface of the U-shaped base.

[0137] Clause 35. The carrier system of clause 28, wherein the first elongated slot is sized to receive the first radioactive seed via snap fit or friction fit to cover at least a portion of an exterior surface of the first radioactive seed.

[0138] Clause 36. The carrier system of clause 28, further comprising: a high-z shielding layer positioned in the first elongated slot and the second elongated slot between the base and the radioactive seeds.

[0139] Clause 37. The carrier system of clause 35, wherein the shielding layer covers only a portion of the elongated slots.

[0140] Clause 38. A [U] wrapper comprising: a substantially U-shaped base having a first insertion arm and a second insertion arm that are held in a substantially parallel relationship by a connecting arm therebetween, wherein the first insertion arm includes a first elongated slot at least partially covered with a shielding material and configured to receive at least a portion of a first radioactive seed and the second insertion arm includes a second elongated slot at least partially covered with the shielding material and configured to receive at least a portion of a second radioactive seed.

[0141] Clause 39. The wrapper of clause 37, wherein the wrapper, with the first radioactive seed positioned at least partially within the first elongated slot of thefirst insertion arm and the second radioactive seed positioned at least partially within the second elongated slot of the second insertion arm, is configured for attachment to a biocompatible carrier by insertion of the insertion arms into a side of the biocompatible carrier until the radioactive seeds are at least partially embedded within the biocompatible carrier.

[0142] Clause 40. The carrier system of clause 38, wherein the radioactive seeds are sufficiently inserted into the biocompatible carrier when the connecting arm contacts the side of the biocompatible material.

[0143] Clause 41 . The carrier system of clause 28, wherein the connecting arm is removably attachable to the first and second insertion arms.

[0144] Clause 42. The carrier system of clause 30, wherein the connecting arm is removed from the first and second insertion arms prior to placement of the biocompatible carrier on the exposed treatment surface of the surgically-created cavity.

[0145] Clause 43. The carrier system of clause 28, wherein the connecting arm is configured to be cut from the first and second insertion arms prior to placement of the biocompatible carrier on the exposed treatment surface of the surgically-created cavity. 44. 45.

[0146] Clause 46. The carrier system of clause 1 , 14, or 28, wherein at least one of the wrappers comprises one or more protrusions configure to secure the wrapper to the carrier.

[0147] Clause 47. The carrier system of clause 1 , 14, or 28, wherein at least one of the wrappers comprises one or more protrusions configured to increase a rotational inertia to reduce rotation relative to the carrier.

[0148] Clause 48. The carrier system of clause 1 , 14, or 28, wherein the shielding layer comprises a plurality of individual, discrete layers of one or more high Z materials.

[0149] Clause 49. The carrier system of clause 1 , 14, or 28, wherein the shielding layer is embedded in an interior region of the wrapper.

[0150] Clause 50. The carrier system of clause 1 , 14, or 28, wherein the shielding layer is positioned on an exterior surface of the wrapper.

[0151] Clause 51. The carrier system of clause 1 , 14, or 28, wherein the shielding layer has a half value layer (HVL) of two.

[0152] Clause 52. The carrier system of clause 1 , 14, or 28, wherein the wrappers have a thickness of between about 0.2 mm and 0.7 mm.

[0153] Clause 53. The carrier system of clause 1 , 14, or 28, wherein the shielding layer has a thickness of between about 0.01 mm and 0.06 mm.

[0154] Clause 54. The carrier system of clause 1 , 14, or 28, wherein the wrappers comprise plastic or polymer.

[0155] Clause 55. The carrier system of clause 1 , 14, or 28, wherein the carrier comprises collagen.

[0156] Clause 56. A method of assembling a radiation delivery device, the method comprising: providing a wrapper having at least one elongated slot sized to receive a radioactive seed; attaching a shielding layer to at least a portion of the at least one elongated slot; inserting a radioactive seed into each of the at least one elongated slot so that the shielding layer is between the radioactive seed and the wrapper; and attaching the wrapper to a biocompatible carrier so that the radioactive seed is held in place between the wrapper and the biocompatible carrier.

[0157] Clause 57. The method of clause 53, wherein the wrapper comprises polymer and the shielding layer comprises a gold foil.

[0158] Clause 58. The method of clause 53, wherein the wrapper comprises one of a button wrapper, strip wrapper, or U-wrapper.Additional Embodiments

[0159] Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment.

[0160] It should be emphasized that many variations and modifications may be made to the above-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. The foregoing description details certain embodiments of the invention. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the invention can be practiced in many ways. As is also stated above, the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the invention with which that terminology is associated. The scope of the invention should therefore be construed in accordance with the appended claims and any equivalents thereof.

Claims

WHAT IS CLAIMED IS:

1. A carrier system for delivering directional radiation treatment to a tissue site according to a dosimetric plan, the carrier system comprising: a biocompatible carrier configured to be placed on an exposed treatment surface of a surgically-created cavity in mammalian tissue; a wrapper comprising: a substantially U-shaped base having a first insertion arm and a second insertion arm that are held in a substantially parallel relationship by a connecting arm therebetween, wherein the first insertion arm includes a first elongated slot sized to receive at least a portion of a first radioactive seed and the second insertion arm includes a second elongated slot sized to receive at least a portion of a second radioactive seed; wherein the wrapper, with the first radioactive seed positioned at least partially within the first elongated slot of the first insertion arm and the second radioactive seed positioned at least partially within the second elongated slot of the second insertion arm, is configured for attachment to the biocompatible carrier by insertion of the insertion arms into a side of the biocompatible carrier until the radioactive seeds are at least partially embedded within the biocompatible carrier.

2. The carrier system of claim 1 , wherein the radioactive seeds are sufficiently inserted into the biocompatible carrier when the connecting arm contacts the side of the biocompatible material.

3. The carrier system of claim 1 , wherein the connecting arm is removably attachable to the first and second insertion arms.

4. The carrier system of claim 3, wherein the connecting arm is removed from the first and second insertion arms prior to placement of the biocompatible carrier on the exposed treatment surface of the surgically-created cavity.

5. The carrier system of claim 1 , wherein the connecting arm is configured to be cut from the first and second insertion arms prior to placementof the biocompatible carrier on the exposed treatment surface of the surgically- created cavity.

6. The carrier system of claim 1 , wherein the first elongated slot is sized to receive at least half of the first radioactive seed such that less than half of the radioactive seed is above a top surface of the U-shaped base.

7. The carrier system of claim 1 , wherein the first elongated slot is sized to receive the first radioactive seed via snap fit or friction fit to cover at least a portion of an exterior surface of the first radioactive seed.

8. The carrier system of claim 1 , further comprising: a high-z shielding layer positioned in the first elongated slot and the second elongated slot between the base and the radioactive seeds.

9. The carrier system of claim 8, wherein the shielding layer covers only a portion of the elongated slots.

10. A wrapper comprising: a substantially U-shaped base having a first insertion arm and a second insertion arm that are held in a substantially parallel relationship by a connecting arm therebetween, wherein the first insertion arm includes a first elongated slot at least partially covered with a shielding material and configured to receive at least a portion of a first radioactive seed and the second insertion arm includes a second elongated slot at least partially covered with the shielding material and configured to receive at least a portion of a second radioactive seed.

11. The wrapper of claim 10, wherein the wrapper, with the first radioactive seed positioned at least partially within the first elongated slot of the first insertion arm and the second radioactive seed positioned at least partially within the second elongated slot of the second insertion arm, is configured for attachment to a biocompatible carrier by insertion of the insertion arms into a side of the biocompatible carrier until the radioactive seeds are at least partially embedded within the biocompatible carrier.

12. The carrier system of claim 11 , wherein the radioactive seeds are sufficiently inserted into the biocompatible carrier when the connecting arm contacts the side of the biocompatible material.

13. The carrier system of claim 10, wherein at least one of the insertion arms comprises one or more protrusions configured to secure the wrapper to the carrier.

14. The carrier system of claim 10, wherein at least one of the insertion arms comprises one or more protrusions configured to increase a rotational inertia to reduce rotation relative to the carrier.

15. The carrier system of claim 10, wherein the shielding material has a half value layer (HVL) of two.

16. The carrier system of claim 10, wherein the wrapper comprises plastic or polymer.

17. The carrier system of claim 10, wherein the carrier comprises collagen.

18. A wrapper comprising a base having a connecting member and at least one insertion arm extending generally orthogonally therefrom, wherein said at least one insertion arm includes a slot at least partially covered with a shielding material and configured to receive at least a portion of a radioactive seed.

19. The wrapper of claim 18, further comprising a second insertion arm extending from the connecting member in substantially parallel and spaced apart relationship with said at least one arm.

20. The wrapper of claim 18, wherein the second insertion arm includes a second slot at least partially covered with the shielding material and configured to receive at least a portion of a second radioactive seed.

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