Patent Description:
The applicator taught by <CIT> is devoid of grooves and projections as set out in the present claims.

The present invention provides a method of manufacturing an applicator as claimed in the claims hereto. Suitably, a method of manufacturing an applicator according to the present invention is a method of manufacturing a brachytherapy applicator. Furthermore, the present invention provides a brachytherapy applicator as claimed in the claims hereto.

At least one example embodiment of the present invention relates to a method of manufacturing a brachytherapy applicator.

In at least one example embodiment, the method includes the steps defined in claim <NUM>.

In at least one example embodiment, the providing the shaft includes forming the shaft by additive manufacturing. In at least one example embodiment, the providing a cap includes forming the cap by additive manufacturing. In at least one example embodiment, the providing the base portion includes forming the base portion by additive manufacturing.

In at least one example embodiment, the forming an applicator further includes applying a resin between the shaft and the cap, and curing the resin and/or, the forming an applicator further includes applying the resin between the shaft and the base portion, and curing the resin. For example, the resin may be applied to the top surface of the shaft and/or to the mating surface of the cap. The resin may also be introduced into the first groove, the second groove, and/or the one or more holes of the shaft. After applying the resin and connecting the cap to the shaft, the resin is cured such that the cap is secured to the shaft.

The first end of the shaft comprises a top surface. Suitably, the top surface defines a first groove and a second groove and the second groove circumscribes the first groove.

The cap includes a mating surface configured to be coupled to the top surface of the shaft. Suitably, a first plurality of projections extend from the mating surface, and a second plurality of projections extend from the mating surface and circumscribe the first plurality of projections.

The step of connecting the cap to the first end of the shaft includes engaging the first plurality of projections of the cap with the first groove of the shaft and engaging the second plurality of projections of the cap with the second groove of the shaft.

In at least one example embodiment, the first end of the shaft comprises a top surface and the top surface defines one or more holes. Suitably, the cap includes a mating surface configured to be coupled to the top surface of the shaft and one or more positioning elements extending from the mating surface.

In at least one example embodiment, the connecting the cap to the first end of the shaft includes inserting the one or more positioning elements of the cap into the one or more holes of the shaft.

In at least one example embodiment, the method further comprises forming an inlet in a side of the shaft adjacent the first end of the shaft, forming an outlet in another side of the shaft, and applying a resin between the shaft and the cap through the inlet.

In at least one example embodiment, the forming the applicator further comprises coupling a plurality of connectors to the base portion and applying a resin between the connectors and the base portion.

In at least one example embodiment, the applicator includes a primary channel and one or more secondary channels. The primary channel may extend through a center of the applicator through the base portion, the shaft, and the cap. The one or more secondary channels may circumscribe the primary channel. For example, the one or more secondary channel may be equidistantly spaced apart about the primary channel. In at least one example embodiment, the one or more secondary channel extends from a second section of the base portion, along the shaft, and at least partially through the cap. The one or more secondary channels may comprise two to eight channels. In at least one example embodiment, the one or more secondary channels comprises six channels.

In at least one example embodiment, the shaft includes a first central channel extending from the first end to the second end. The shaft may comprise a first plurality of lumens extending from the first end to the second end. In at least one example embodiment, the first plurality of lumens may be positioned between the first central channel and the exterior surface of the shaft. For example, the first plurality of lumens may be positioned between the first groove and the second groove. The first plurality of lumens may form at least a portion of the one or more secondary channels extending through the shaft. The first plurality of lumens are suitably positioned circumferentially about the first central channel. The first plurality of lumens may be equidistantly spaced about the first central channel. The first plurality of lumens may comprise two to eight lumens. In at least one example embodiment, the first plurality of lumens comprises six lumens.

The cap suitably includes a second central channel extending through a center of the cap. Suitably, the second central channel is configured to be coupled to the first central channel of the shaft. For example, the second central channel may form at least a portion of the primary channel extending through the cap. Suitably, the cap further comprises a plurality of holes extending at least partially through the cap. Suitably, the plurality of holes are positioned circumferentially about the second central channel and configured to be coupled to the first plurality of lumens. In at least one example embodiment, the plurality of holes of the cap may comprise two to eight holes. In at least one example embodiment, the plurality of holes may comprise six holes.

The base portion may include a third central channel extending through a center of the base portion and a second plurality of lumens extending through the base portion. In at least one example embodiment, the second plurality of lumens comprises two to eight lumens. In at least one example embodiment, the second plurality of lumens comprises six lumens. The third central channel is suitably configured to be coupled to the first central channel and the second plurality of lumens are suitably positioned circumferentially about the third central channel and configured to be coupled to the first plurality of lumens. In an embodiment of the invention, the shaft includes a first plurality of projections and a second plurality of projections extending from the bottom surface thereof. The first plurality of projections may circumscribe the first central channel. The second plurality of projections may circumscribe the first plurality of projections. In at least one example embodiment, the second plurality of projections may be positioned adjacent an outer perimeter of the shaft. For example, the second plurality of projections may be between the outer perimeter of the shaft and the first plurality of lumens. In at least one example embodiment, the first plurality of projections is configured to engage the first groove of the base portion and the second plurality of projections is configured to engage the second groove of the base portion such that the base portion is secured to the second end of the shaft. In at least one example embodiment, the shaft includes one or more positioning elements extending from the bottom surface. The one or more positioning elements may be positioned between the first plurality of projections and the second plurality of projections. In at least one example embodiment, the one or more holes in the mating surface of the base portion are configured to receive the one or more positioning elements. In at least one example embodiment, the one or more positioning elements may comprise three positioning elements. In at least one example embodiment, the one or more positioning elements are spaced equidistantly about the first central channel. In at least one example embodiment, the one or more positioning elements may comprise a flexible material.

In at least one example embodiment, the shaft, the cap, and/or the base portion comprise a resin or a plastic material. In at least one example embodiment, the shaft, the cap, and/or the base portion of the applicator may comprise transparent, non-transparent, or a combination of both transparent and non-transparent materials. In at least one example embodiment, surfaces of or materials forming the applicator may also be provided with antibacterial additives such as copper, silver, and/or graphene.

In at least one example embodiment, the method further comprises cleaning the shaft, the base portion, and/or the cap before the forming the applicator.

At least one example embodiment relates to a brachytherapy applicator for insertion into a body cavity.

In at least one example embodiment, the brachytherapy applicator includes a shaft and a cap. The shaft has a first end and a second end opposite the first end. The shaft also includes a top surface adjacent the first end of the shaft. The top surface defines a first groove and a second groove. In at least one example embodiment, the first groove circumscribes a first central channel extending through the shaft from the first end to the second end. The first central channel may form at least a portion of the primary channel. The second groove may circumscribe the first groove. For example, the second groove may be positioned adjacent an exterior surface of the shaft. In at least one example embodiment, the top surface of the shaft defines one or more holes. The one or more holes may be positioned between the first groove and the second groove. In at least one example embodiment, the one or more holes comprises three holes. The one or more holes may be spaced equidistantly about a circumference of the top surface of the shaft.

The cap is suitably configured to be coupled to the first end of the shaft. The cap includes a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface and a second plurality of projection extending from the mating surface. The first plurality of projections are configured to engage the first groove. The second plurality of projections suitably circumscribe the first plurality of projections and are configured to engage the second groove. In at least one example embodiment, the second plurality of projections may be positioned adjacent an outer perimeter of the first side of the cap.

In at least one example embodiment, the cap comprises one or more positioning elements extending from the mating surface. The one or more positioning elements may be positioned between the first plurality of projections and the second plurality of projections. Suitably, the top surface of the shaft defines one or more holes configured to receive the one or more positioning elements. In at least one example embodiment, the one or more positioning elements may comprise three positioning elements. The one or more positioning elements may be equidistantly spaced about a circumference of the cap. In at least one example embodiment, the one or more positioning elements may comprise a flexible material. The flexible material may enable the one or more positioning elements to be inserted into the one or more holes of the shaft by a snap-fit and/or a form-fit.

In at least one example embodiment, the shaft includes a first central channel extending from the first end to the second end and a first plurality of lumens extending from the first end to the second end. The first plurality of lumens are suitably positioned circumferentially about the first central channel. Suitably, the cap includes a second central channel extending through a center of the cap and a plurality of holes extending at least partially through the cap. The second central channel is suitably configured to be coupled to the first central channel. Suitably, the plurality of holes are positioned circumferentially about the second central channel and configured to be coupled to the first plurality of lumens.

In at least one example embodiment, the second end of the shaft includes a base portion. The base portion may include a first section, a second section, and a third section. The second section may be positioned between the first section and the third section of the base portion. In some example embodiments, the base portion and the shaft are a single unitary piece. In other example embodiments, the base portion may be a separate piece configured to be coupled to the second end of the shaft. In such embodiments, the first section of the base portion is configured to be coupled to the second end of the shaft.

In at least one example embodiment, the base portion suitably includes a first section configured to be coupled to the second end of the shaft; a second section including an exterior surface; a third section; a third central channel extending through the first section, the second section, and the third section; and a second plurality of lumens extending through the first section and the second section of the base portion. Suitably, the exterior surface is at an angle relative to a horizontal axis through the base portion. The second section is suitably between the first section and the third section.

In at least one example embodiment, the angle is greater than or equal to <NUM>°. Suitably, the angle of the exterior surface of the base portion relative to a horizontal axis through the base portion is greater than <NUM>°, suitably greater than <NUM>°, for example, greater than or equal to <NUM>°. Suitably, the angle of the exterior surface of the base portion is at an angle relative to a horizontal axis through the base portion of less than <NUM>°, for example, less than <NUM>°, or less than <NUM>°, or less than <NUM>°. Suitably, the angle of the exterior surface of the base portion is at an angle relative to a horizontal axis through the base portion of around <NUM>°.

In at least one example embodiment, the brachytherapy applicator further comprises a plurality of connectors configured to be at least partially inserted into the first plurality of lumens of the third section of the base portion.

In at least one example embodiment, the brachytherapy applicator further comprises a source of radiation configured to be coupled to the plurality of connectors and to deliver radiation to a target location. The source of radiation may include one or more ports configured to receive one or more wires or cables. For example, a first end of the cable may be coupled to one or the ports and a second end of the cable may be coupled to one of connectors of the base portion.

Some detailed example embodiments are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing some example embodiments. Example embodiments may, however, be embodied in many alternate forms and should not be construed as limited to only example embodiments set forth herein.

Accordingly, while example embodiments are capable of various modifications and alternative forms, example embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit an example embodiment to the particular forms disclosed, but to the contrary, example embodiments are to cover all modifications and alternatives falling within the scope of an example embodiment. Like numbers refer to like elements throughout the description of the figures.

It should be understood that when an element or layer is referred to as being "on," "connected to," "coupled to," or "covering" another element or layer, it may be directly on, connected to, coupled to, or covering the other element or layer or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," "directly connected to," or "directly coupled to" another element or layer, there are no intervening elements or layers present. Like numbers refer to like elements throughout the specification.

It should be understood that, although the terms first, second, third, etc. may be used herein to describe various elements, regions, layers and/or sections, these elements, regions, layers, and/or sections should not be limited by these terms. These terms are only used to distinguish one element, region, layer, or section from another region, layer, or section. Thus, a first element, region, layer, or section discussed below could be termed a second element, region, layer, or section without departing from the teachings of example embodiment.

Spatially relative terms (e.g., "beneath," "below," "lower," "above," "upper," and the like) may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. Thus, the term "below" may encompass both an orientation of above and below.

The terminology used herein is for the purpose of describing various example embodiment only and is not intended to be limiting of example embodiment. It will be further understood that the terms "includes," "including," "comprises," and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, and/or elements, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements and/or groups thereof.

Example embodiments are described herein with reference to cross-sectional illustrations that are schematic illustrations of example embodiment. As such, variations from the shapes of the illustrations are to be expected. Thus, example embodiment should not be construed as limited to the shapes of regions illustrated herein but are to include deviations and variations in shapes.

When the words "about" and "substantially" are used in this specification in connection with a numerical value, it is intended that the associated numerical value include a tolerance of ±<NUM>% around the stated numerical value, unless otherwise explicitly defined. Moreover, when the terms "generally" or "substantially" are used in connection with geometric shapes, it is intended that precision of the geometric shape is not required but that latitude for the shape is within the scope of the disclosure. Furthermore, regardless of whether numerical values or shapes are modified as "about," "generally," or "substantially," it will be understood that these values and shapes should be construed as including a manufacturing or operational tolerance (e.g., ±<NUM>%) around the stated numerical values or shapes.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiment belong.

<FIG> is a front view of a brachytherapy applicator according to at least one example embodiment.

An applicator <NUM> may be inserted into a body cavity for brachytherapy treatment. The applicator <NUM> includes a shaft <NUM> having a first end <NUM> and a second end <NUM> opposite the first end <NUM>. In at least one example embodiment, the shaft <NUM> has a cylindrical shape. In at least one example embodiment, the applicator <NUM> includes a cap <NUM> configured to be coupled to the first end <NUM> of the shaft <NUM>, as will be discussed in relation to <FIG>, below.

In at least one example embodiment, the applicator <NUM> includes a base portion <NUM> at the second end <NUM> of the shaft <NUM>. In at least one example embodiment, the base portion <NUM> includes a first section <NUM>, a second section <NUM>, and a third section <NUM>. The second section <NUM> is positioned between the first section <NUM> and the third section <NUM> of the base portion <NUM>. In some example embodiments, the base portion <NUM> and the shaft <NUM> are a single unitary piece. In other example embodiments, the base portion <NUM> may be a separate piece configured to be coupled to the second end <NUM> of the shaft <NUM>, as will be discussed in relation to <FIG>, below. In such embodiments, the first section <NUM> of the base portion <NUM> is configured to be coupled to the second end <NUM> of the shaft <NUM>.

In at least one example embodiment, the second section <NUM> of the base portion <NUM> includes an exterior surface <NUM>. The exterior surface <NUM> may form an angle <NUM> relative to the axis <NUM> through the base portion <NUM>. In at least one example embodiment, the angle <NUM> may be greater than or equal to about <NUM>°.

<FIG> is a section view of the applicator <NUM> of <FIG> along line I-I according to at least one example embodiment.

In at least one example embodiment, the applicator <NUM> includes a primary channel <NUM> and one or more secondary channels <NUM>. The primary channel <NUM> may extend through a center of the applicator <NUM> through the base portion <NUM>, the shaft <NUM>, and the cap <NUM>. The one or more secondary channels <NUM> may circumscribe the primary channel <NUM>. For example, the one or more secondary channel <NUM> may be equidistantly spaced apart about the primary channel <NUM>. In at least one example embodiment, the one or more secondary channel <NUM> extend from the second section <NUM> of the base portion <NUM> (as shown in <FIG>), the shaft <NUM>, and at least partially through the cap <NUM>. The one or more secondary channels <NUM> may comprise two to eight channels. In at least one example embodiment, the one or more secondary channels <NUM> comprises six channels.

In at least one example embodiment, the shaft <NUM>, the cap <NUM>, and/or the base portion <NUM> of the applicator <NUM> may comprise a resin or a plastic material. Such materials allow the applicator <NUM> to be safe in magnetic resonance environments ("MR-Safe"). For example, the materials will not interact with magnetic imaging, such as magnetic resonance imaging ("MRI"). In at least one example embodiment, the shaft <NUM>, the cap <NUM>, and/or the base portion <NUM> of the applicator <NUM> may comprise transparent, non-transparent, or a combination of both transparent and non-transparent materials. Transparent materials allow sterilization, cleaning, and disinfection of the application <NUM> to be checked visually. In at least one example embodiment, surfaces of or materials forming the applicator <NUM> may also be provided with antibacterial additives such as copper, silver, and/or graphene.

<FIG> is a top perspective view of the shaft <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment.

In at least one example embodiment, the first end <NUM> of the shaft <NUM> includes a top surface <NUM>. The top surface <NUM> defines a first groove <NUM> and a second groove <NUM>. In at least one example embodiment, the first groove <NUM> circumscribes a first central channel <NUM> extending through the shaft <NUM> from the first end <NUM> to the second end <NUM>. The first central channel <NUM> may form at least a portion of the primary channel <NUM>, as shown in <FIG>. In at least one example embodiment, the second groove <NUM> circumscribes the first groove <NUM>. For example, the second groove <NUM> may be positioned adjacent an exterior surface of the shaft <NUM>.

In at least one example embodiment, the top surface <NUM> of the shaft <NUM> defines one or more holes <NUM>. The one or more holes <NUM> may be positioned between the first groove <NUM> and the second groove <NUM>. In at least one example embodiment, the one or more holes <NUM> comprises three holes. The one or more holes <NUM> may be spaced equidistantly about a circumference of the top surface <NUM> of the shaft <NUM>.

In at least one example embodiment, the shaft <NUM> may include a first plurality of lumens <NUM> extending from the first end <NUM> to the second end <NUM>. The first plurality of lumens <NUM> may form at least a portion of the one or more secondary channels <NUM> extending through the shaft <NUM>, as shown in <FIG>. In at least one example embodiment, the first plurality of lumens <NUM> may be positioned between the first central channel <NUM> and the exterior surface of the shaft <NUM>. For example, the first plurality of lumens <NUM> may be positioned between the first groove <NUM> and the second groove <NUM>. The first plurality of lumens <NUM> may also be aligned with the one or more holes <NUM> in some example embodiments. In at least one example embodiment, the first plurality of lumens <NUM> may be positioned circumferentially about the first central channel <NUM>. The first plurality of lumens <NUM> may be equidistantly spaced about the first central channel <NUM>. The first plurality of lumens <NUM> may comprise two to eight lumens. In at least one example embodiment, the first plurality of lumens <NUM> comprises six lumens.

<FIG> is a front perspective view of the cap <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment. <FIG> is a sectional view of the cap <NUM> of <FIG> along line IV-IV according to at least one example embodiment.

In at least one example embodiment, the cap <NUM> includes a first side <NUM> and a second side <NUM>. The first side <NUM> of the cap <NUM> includes a mating surface <NUM> configured to be coupled to the top surface <NUM> of the shaft <NUM>. In at least one example embodiment, the cap <NUM> defines a second central channel <NUM> through a center of the cap <NUM> and extending from the first side <NUM> to the second side <NUM> (as shown in <FIG>). The second central channel <NUM> is configured to be coupled to the first central channel <NUM> of the shaft <NUM>. For example, the second central channel <NUM> may form at least a portion of the primary channel <NUM> extending through the cap <NUM>, as shown in <FIG>.

In at least one example embodiment, the cap <NUM> includes a first plurality of projections <NUM> and a second plurality of projections <NUM> extending from the mating surface <NUM>. The first plurality of projections <NUM> may circumscribe the second central channel <NUM>. The second plurality of projections <NUM> may circumscribe the first plurality of projections <NUM>. In at least one example embodiment, the second plurality of projections <NUM> may be positioned adjacent an outer perimeter of the first side <NUM> of the cap <NUM>. In at least one example embodiment, the first plurality of projections <NUM> is configured to engage the first groove <NUM> of the shaft <NUM> and the second plurality of projections <NUM> is configured to engage the second groove <NUM> such that the cap <NUM> is secured to the first end <NUM> of the shaft <NUM>, as shown in <FIG>.

In at least one example embodiment, the cap <NUM> includes one or more positioning elements <NUM> extending from the mating surface <NUM>. The one or more positioning elements <NUM> may be positioned between the first plurality of projections <NUM> and the second plurality of projections <NUM>. The one or more holes <NUM> in the top surface <NUM> of the shaft <NUM> are configured to receive the one or more positioning elements <NUM> (as shown in <FIG>). The one or more positioning elements <NUM> are configured to align the cap <NUM> with the shaft <NUM> such that the cap <NUM> is properly positioned and secured to the shaft <NUM>. For example, the one or more positioning elements <NUM> are configured to be inserted into the one or more holes <NUM> of the shaft <NUM>, as shown in <FIG>. In at least one example embodiment, the one or more positioning elements <NUM> may comprise three positioning elements. The one or more positioning elements <NUM> may be equidistantly spaced about a circumference of the cap <NUM>. In at least one example embodiment, the one or more positioning elements <NUM> may comprise a flexible material. The flexible material may enable the one or more positioning elements <NUM> to be inserted into the one or more holes <NUM> of the shaft <NUM> by a snap-fit and/or a form-fit.

In at least one example embodiment, the cap <NUM> defines a plurality of holes <NUM> extending through at least a portion of the cap <NUM> from the first side <NUM> toward the second side <NUM>. The plurality of holes <NUM> may be positioned between the first plurality of projections <NUM> and the second plurality of projections <NUM>. The plurality of holes <NUM> may also be positioned circumferentially about the second central channel <NUM>. The plurality of holes <NUM> are configured to be coupled to the first plurality of lumens <NUM> of the shaft <NUM>. For example, the plurality of holes <NUM> may form at least a portion of the one or more secondary channels <NUM> extending into the cap <NUM>, as shown in <FIG>. In at least one example embodiment, the plurality of holes <NUM> may comprise two to eight holes. In at least one example embodiment, the plurality of holes may comprise six holes.

<FIG> is a detailed interior view of the shaft <NUM> and the cap <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment.

In at least one example embodiment, the first groove <NUM> and the second groove <NUM> of the shaft <NUM> are configured to receive and engage the first plurality of projections <NUM> and the second plurality of projections <NUM> of the cap <NUM>, respectively. In at least one example embodiment, a resin may be applied between the shaft <NUM> and the cap <NUM>. For example, the resin may be applied to the top surface <NUM> of the shaft <NUM> and/or to the mating surface <NUM> of the cap <NUM>. The resin may also be introduced into the first groove <NUM>, the second groove <NUM>, and/or the one or more holes <NUM> of the shaft. After applying the resin and connecting the cap <NUM> to the shaft <NUM>, the resin is cured such that the cap <NUM> is secured to the shaft <NUM>.

In at least one example embodiment, a resin may be introduced between the cap <NUM> and the shaft <NUM> after the cap <NUM> and the shaft <NUM> are already connected. For example, the shaft <NUM> may include an inlet <NUM> in a side of the shaft adjacent the first end <NUM> of the shaft <NUM>. The shaft <NUM> may also include a channel <NUM> fluidly coupling the inlet <NUM> with one or more of the holes <NUM>. Resin may be introduced to the one or more holes <NUM> through the inlet <NUM> and the channel <NUM>. The resin may also flow from the one or more holes <NUM> along the top surface <NUM> of the shaft and the mating surface <NUM> of the cap <NUM>, and into the first groove <NUM> and the second groove <NUM>.

In at least one example embodiment, the shaft <NUM> also includes an outlet <NUM> opposite the inlet <NUM>. For example, the outlet <NUM> may be fluidly coupled to the second groove <NUM> on a side of the shaft <NUM> opposite the inlet <NUM>. The outlet <NUM> may also be positioned above the inlet <NUM> and the channel <NUM>. For example, the outlet <NUM> may be positioned closer to the first end <NUM> of the shaft <NUM> than the inlet <NUM>. In another example embodiment, the outlet <NUM> may be disposed in the cap <NUM> adjacent the second plurality of projections <NUM> and opposite the inlet <NUM>. The outlet <NUM> may be configured to allow air and excess resin to flow out as resin is introduced through the inlet <NUM>.

<FIG> is a top perspective view of the base portion <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment.

In at least one example embodiment, the first section <NUM> of the base portion <NUM> includes a mating surface <NUM>. The mating surface <NUM> may be similar or analogous to the top surface <NUM> of the shaft <NUM>, as shown in <FIG>. The mating surface <NUM> defines a first groove <NUM> and a second groove <NUM>. In at least one example embodiment, the first groove <NUM> circumscribes a third central channel <NUM>. The third central channel <NUM> extends through the first section <NUM>, the second section <NUM>, and the third section <NUM> of the base portion <NUM> and may form at least a portion of the primary channel <NUM>, as discussed above with respect to <FIG>. In at least one example embodiment, the second groove <NUM> is adjacent an outer perimeter of the base portion <NUM> and circumscribes the first groove <NUM>.

In at least one example embodiment, the mating surface <NUM> of the base portion <NUM> defines one or more holes <NUM>. The one or more holes <NUM> may extend from the mating surface <NUM> at least partially into the first section <NUM> of the base portion <NUM>. In at least one example embodiment, the one or more holes <NUM> comprises three holes. In at least one example embodiment, the one or more holes <NUM> may be positioned between the first groove <NUM> and the second groove <NUM> and equidistantly spaced apart about the third central channel <NUM>.

In at least one example embodiment, the base portion <NUM> includes a second plurality of lumens <NUM>. The second plurality of lumens <NUM> may extend through the first section <NUM> and the second section <NUM> of the base portion <NUM> and form at least a portion of the one or more secondary channels <NUM>, as discussed above with respect to <FIG>. In at least one example embodiment, the second plurality of lumens <NUM> may be positioned between the first groove <NUM> and the second groove <NUM>. The second plurality of lumens <NUM> may also be aligned with the one or more holes <NUM> in some embodiments. In at least one example embodiment, the second plurality of lumens <NUM> may be equidistantly spaced apart about the third central channel <NUM>. In at least one example embodiment, the second plurality of lumens <NUM> comprises two to eight lumens. In at least one example embodiment, the second plurality of lumens <NUM> comprises six lumens.

<FIG> is a detailed, section view of the second end <NUM> of the shaft <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment.

In at least one example embodiment, the second end <NUM> of the shaft <NUM> includes a bottom surface <NUM>. The bottom surface <NUM> of the shaft <NUM> may be similar or analogous to the mating surface <NUM> of the cap <NUM>, discussed above with respect to <FIG>. The mating surface <NUM> of the base portion <NUM> is configured to be coupled to the bottom surface <NUM> of the shaft <NUM>, as will be discussed in <FIG>, below.

In at least one example embodiment, the shaft <NUM> includes a first plurality of projections <NUM> and a second plurality of projections <NUM> extending from the bottom surface <NUM>. The first plurality of projections <NUM> may circumscribe the first central channel <NUM>. The second plurality of projections <NUM> may circumscribe the first plurality of projections <NUM>. In at least one example embodiment, the second plurality of projections <NUM> may be positioned adjacent an outer perimeter of the shaft <NUM>. For example, the second plurality of projections <NUM> may be between the outer perimeter of the shaft <NUM> and the first plurality of lumens <NUM>. In at least one example embodiment, the first plurality of projections <NUM> is configured to engage the first groove <NUM> of the base portion <NUM> and the second plurality of projections <NUM> is configured to engage the second groove <NUM> of the base portion <NUM> such that the base portion <NUM> is secured to the second end <NUM> of the shaft <NUM>.

In at least one example embodiment, the shaft <NUM> includes one or more positioning elements <NUM> extending from the bottom surface <NUM>. The one or more positioning elements <NUM> may be positioned between the first plurality of projections <NUM> and the second plurality of projections <NUM>. In at least one example embodiment, the one or more holes <NUM> in the mating surface <NUM> of the base portion <NUM> are configured to receive the one or more positioning elements <NUM>. The one or more positioning elements <NUM> are configured to align the shaft <NUM> and the base portion <NUM> such that the base portion <NUM> is properly positioned and secured to the shaft <NUM>. In at least one example embodiment, the one or more positioning elements <NUM> may comprise three positioning elements. In at least one example embodiment, the one or more positioning elements <NUM> are spaced equidistantly about the first central channel <NUM>. In at least one example embodiment, the one or more positioning elements <NUM> may comprise a flexible material. The flexible material may enable the one or more positioning elements <NUM> to be inserted into the one or more holes <NUM> of the base portion <NUM> by a snap-fit and/or a form-fit.

<FIG> is a detailed section view of the shaft <NUM> and the base portion <NUM> of the applicator <NUM> of <FIG> according to at least one example embodiment.

In at least one example embodiment, the first groove <NUM> and the second groove <NUM> of the base portion <NUM> are configured to receive and engage the first plurality of projections <NUM> and the second plurality of projections <NUM> of the shaft <NUM>, respectively. In at least one example embodiment, a resin may be applied between the base portion <NUM> and the shaft <NUM>. For example, the resin may be applied to the mating surface <NUM> of the base portion <NUM> and/or the bottom surface <NUM> of the shaft <NUM> before connecting the base portion <NUM> and the shaft <NUM>. The resin may also be introduced into the first groove <NUM>, the second groove <NUM>, and/or the one or more holes <NUM>. After the resin is applied and the base portion <NUM> is connected to the shaft <NUM>, the resin may be cured such that the base portion <NUM> is secured to the shaft <NUM>.

<FIG> is a detailed section view of the shaft and the base portion of the applicator of <FIG> according to at least one example embodiment.

In at least one example embodiment, the resin may be introduced between the shaft <NUM> and the base portion <NUM> after the base portion <NUM> is coupled to the shaft <NUM>. For example, the base portion <NUM> may include an inlet <NUM> for introducing the resin. The inlet may also include a channel <NUM> configured to fluidly couple the inlet <NUM> to the one or more holes <NUM>. The shaft <NUM> may also include an outlet <NUM> opposite the inlet for allowing air and excess resin to flow out from between the shaft <NUM> and the base portion <NUM>. In at least one example embodiment, the outlet <NUM> is fluidly coupled to the second groove <NUM>. The inlet <NUM>, the channel <NUM>, and the outlet <NUM> may be similar or analogous to the inlet <NUM>, the channel <NUM>, and the outlet <NUM>, as discussed above with respect to <FIG>. For example, the resin may be introduced to the one or more holes <NUM> of the base portion <NUM> through the inlet <NUM> and the channel <NUM>. The resin may also flow from the one or more holes <NUM> along the mating surface <NUM> of the base portion and the bottom surface <NUM> of the shaft <NUM>, and into the first groove <NUM> and the second groove <NUM>. The outlet <NUM> may be configured to allow air and excess resin to flow out from between the base portion <NUM> and the shaft <NUM>.

<FIG> is a detailed perspective view of the base portion <NUM> of <FIG> according to at least one example embodiment. <FIG> is a section view of the base portion <NUM> of <FIG> along line XI-XI according to at least one example embodiment.

In at least one example embodiment, a plurality of connectors <NUM> may be configured to be at least partially inserted into the second plurality of lumens <NUM> of the base portion <NUM>. For example, the exterior surface <NUM> of the second section <NUM> of the base portion <NUM> may define a plurality of openings <NUM>. The plurality of openings may be coupled to the second plurality of lumens <NUM> and configured to receive the plurality of connectors <NUM>. The plurality of connectors <NUM> may comprise the same material as the shaft <NUM>, the cap <NUM>, and/or the base portion <NUM> of the applicator <NUM>.

In at least one example embodiment, the plurality of connectors <NUM> may be coupled to the base portion <NUM> with a resin. For example, a resin may be applied to each of the plurality of openings <NUM> and/or the second plurality of lumens <NUM> before inserting the plurality of connectors <NUM>. After inserting the plurality of connectors <NUM> into the plurality of openings <NUM>, the resin may then be cured such that the plurality of connectors <NUM> are secured to the base portion <NUM>. In at least one example embodiment, the resin applied to the plurality of openings <NUM> and the plurality of connectors <NUM> may be cured at the same time the resin applied between the shaft <NUM> and the base portion <NUM> and/or the resin applied between the shaft <NUM> and the cap <NUM> is cured.

In at least one example embodiment, the plurality of connectors <NUM> are configured to be coupled to the second plurality of lumens <NUM> of the base portion <NUM>, the first plurality of lumens <NUM> of the shaft <NUM>, and the plurality of holes <NUM> of the cap <NUM>. For example, the plurality of connectors <NUM> may be configured to be coupled to the one or more secondary channels <NUM> of the applicator <NUM>, as shown in <FIG>.

<FIG> is a perspective view of the applicator of <FIG> and a source of radiation according to at least one example embodiment. <FIG> is a detailed view of the applicator of <FIG> according to at least one example embodiment.

In at least one example embodiment, the plurality of connectors <NUM> may be coupled to a source of radiation <NUM>. The source of radiation <NUM> may include one or more ports <NUM> configured to receive one or more wires or cables <NUM>. For example, a first end <NUM> of the cable <NUM> may be coupled to one or the ports <NUM> and a second end <NUM> of the cable <NUM> may be coupled to one of the connectors <NUM> (as shown in <FIG>). The applicator <NUM> may be configured to deliver radiation from the source of radiation <NUM> to a target location. For example, radiation may be supplied from the source of radiation <NUM> through the one or more cables <NUM>, the plurality of connectors <NUM>, and the one or more secondary channels <NUM> of the applicator <NUM>.

<FIG> is a flowchart depicting a method of manufacturing an applicator according to at least one example embodiment.

As shown in <FIG>, in at least one example embodiment, the method generally includes providing the shaft <NUM>, the base portion <NUM>, and the cap <NUM> at S1300; connecting the cap <NUM> to the first end <NUM> of the shaft <NUM> at S1301; and connecting the base portion <NUM> to the second end <NUM> of the shaft <NUM> at S1302. Each of these steps is described in greater detail below.

At S1300, in at least one example embodiment, the method includes providing the shaft <NUM>, the base portion <NUM>, and the cap <NUM>. Providing the shaft <NUM>, the cap <NUM>, and the base portion <NUM> includes forming the shaft <NUM>, the cap <NUM>, and the base portion <NUM> by additive manufacturing. In at least one example embodiment, the shaft <NUM> and the base portion <NUM> may be a single unitary piece that may be formed by additive manufacturing. Additive manufacturing allows the shaft <NUM>, the cap <NUM>, and/or the base portion <NUM> to be manufactured modularly. Additive manufacturing also allows the applicator <NUM> to be customizable. For example, the number of channels and the size of the channel, such as the primary channel <NUM> and the one or more secondary channels <NUM> may be customized to suit particular treatment or patient needs. Additionally or alternatively, the length, diameter, and/or angle of the applicator <NUM> may also be customized to suit particular treatment or patient needs. Producing the applicator <NUM> by additive manufacturing may also reduce costs of manufacturing.

In at least one example embodiment, the method further includes cleaning the shaft <NUM>, the cap <NUM>, and the base portion <NUM>. For example, the shaft <NUM>, the cap <NUM>, and the base portion <NUM> may be cleaned before connecting the cap <NUM> to the shaft <NUM> and before connecting the base portion <NUM> to the shaft <NUM>.

At S1301, in at least one example embodiment, the method includes connecting the cap <NUM> to the first end <NUM> of the shaft <NUM>. Connecting the cap <NUM> to the shaft <NUM> may include engaging the first plurality of projections <NUM> of the cap <NUM> with the first groove <NUM> of the shaft <NUM> and/or engaging the second plurality of projections <NUM> of the cap <NUM> with the second groove <NUM> of the shaft <NUM>. In at least one example embodiment, the connecting the cap <NUM> to the shaft <NUM> includes inserting the one or more positioning elements <NUM> of the cap <NUM> into the one or more holes <NUM> of the shaft <NUM>.

As described above in relation to <FIG>, connecting the cap <NUM> to the shaft <NUM> may also include applying a resin between the shaft <NUM> and the cap <NUM>. In at least one example embodiment, the method includes forming the inlet <NUM> and the channel <NUM> in a side of the shaft <NUM> adjacent the first end <NUM> and forming the outlet <NUM> in another side of the shaft <NUM> opposite the inlet <NUM>. In such example embodiment, the method includes applying the resin between the shaft <NUM> and the cap <NUM> through the inlet <NUM>.

At S1302, in at least one example embodiment, the method includes connecting the base portion <NUM> to the second end <NUM> of the shaft <NUM>. Connecting the base portion <NUM> to the shaft <NUM> may include engaging the first plurality of projections <NUM> of the shaft <NUM> with the first groove705 of the base portion and/or engaging the second plurality of projections <NUM> of the shaft <NUM> with the second groove <NUM> of the base portion <NUM>. In at least one example embodiment, connecting the base portion <NUM> to the shaft <NUM> may also include inserting the one or more positioning elements <NUM> of the shaft <NUM> into the one or more holes <NUM> of the base portion <NUM>. The method may further include applying a resin between the shaft <NUM> and the base portion <NUM>. In at least one example embodiment, the resin is applied before connecting the base portion <NUM> to the shaft <NUM>. In other example embodiments, the resin may be applied after the base portion <NUM> is connected to the shaft <NUM>. For example, the shaft <NUM> and/or the base portion <NUM> may include another inlet, channel, and outlet at the second end <NUM> of the shaft <NUM>, similar to the inlet <NUM>, the channel <NUM>, and the outlet <NUM> discussed above with respect to <FIG>.

In at least one example embodiment, the method includes coupling the plurality of connectors <NUM> to the base portion <NUM>. For example, the method may include inserting the plurality of connectors <NUM> into the plurality of openings <NUM> of the base portion <NUM>. The method may further include applying a resin between the base portion <NUM> and the plurality of connectors <NUM>, such as introducing the resin into the plurality of openings <NUM>.

Claim 1:
A method of manufacturing a brachytherapy applicator (<NUM>), comprising:
providing a shaft (<NUM>), the shaft having a first end (<NUM>) and a second end (<NUM>) opposite the first end (<NUM>);
providing a cap (<NUM>);
providing a base portion (<NUM>); and
forming an applicator (<NUM>), the forming including,
connecting the cap (<NUM>) to the first end (<NUM>) of the shaft, and
connecting the base portion (<NUM>) to the second end (<NUM>) of the shaft,
wherein optionally the shaft (<NUM>), the cap (<NUM>), and the base portion (<NUM>) comprise a resin or a plastic material;
wherein the first end (<NUM>) of the shaft comprises a top surface (<NUM>), the top surface defining a first groove (<NUM>) and a second groove (<NUM>), the second groove (<NUM>) circumscribing the first groove (<NUM>), and the cap (<NUM>) includes a mating surface (<NUM>) configured to be coupled to the top surface (<NUM>) of the shaft (<NUM>);
a first plurality of projections (<NUM>) extending from the mating surface (<NUM>); and
a second plurality of projections (<NUM>) extending from the mating surface (<NUM>) and circumscribing the first plurality of projections (<NUM>); and
wherein the connecting the cap to the first end of the shaft comprises:
engaging the first plurality of projections (<NUM>) of the cap (<NUM>) with the first groove (<NUM>) of the shaft (<NUM>); and
engaging the second plurality of projections (<NUM>) of the cap (<NUM>) with the second groove (<NUM>) of the shaft (<NUM>)