Patent Application
20240017092
The present disclosure relates to an applicator for insertion into a body cavity for brachytherapy treatment.
At least one example embodiment related to a method of manufacturing an applicator.
In at least one example embodiment, the method includes providing a shaft. The shaft has a first end and a second end opposite the first end. The method further includes providing a cap, providing a base portion, and forming an applicator. The forming the applicator includes connecting the cap to the first end of the shaft and connecting the base portion to the second end of the shaft.
In at least one example embodiment, the providing the shaft includes forming the shaft by additive manufacturing, the providing a cap includes forming the cap by additive manufacturing, and 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, applying the resin between the shaft and the base portion, and curing the resin.
In at least one example embodiment, the first end of the shaft comprises a top surface. The top surface defines a first groove and a second groove and the second groove circumscribes the first groove.
In at least one example embodiment, the cap includes a mating surface configured to be coupled to the top surface of the shaft, 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.
In at least one example embodiment, the 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. 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 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 positioned circumferentially about the first central channel. 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 configured to be coupled to the first central channel and the plurality of holes are positioned circumferentially about the second central channel and configured to be coupled to the first plurality of lumens. The base portion includes a third central channel extending through a center of the base portion and a second plurality of lumens extending through the base portion. The third central channel is configured to be coupled to the first central channel and the second plurality of lumens positioned circumferentially about the third central channel and configured to be coupled to the first plurality of lumens.
In at least one example embodiment, the shaft, the cap, and the base portion comprise a resin or a plastic material.
In at least one example embodiment, the method further comprises cleaning the shaft, the base portion, and 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. The second groove circumscribes the first groove. The cap is 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 circumscribe the first plurality of projections and are configured to engage the second groove.
In at least one example embodiment, the cap comprises one or more positioning elements extending from the mating surface and 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 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 positioned circumferentially about the first central channel. 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 configured to be coupled to the first central channel. 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 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. The exterior surface is at an angle relative to a horizontal axis through the base portion. The second section is between the first section and the third section.
In at least one example embodiment, the angle is greater than or equal to 45°.
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 various features and advantages of the non-limiting embodiments herein may become more apparent upon review of the detailed description in conjunction with the accompanying drawings. The accompanying drawings are merely provided for illustrative purposes and should not be interpreted to limit the scope of the claims. The accompanying drawings are not to be considered as drawn to scale unless explicitly noted. For purposes of clarity, various dimensions of the drawings may have been exaggerated.
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, equivalents, 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. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
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. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
The terminology used herein is for the purpose of describing various example embodiment only and is not intended to be limiting of example embodiment. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 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 ±10% 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., ±10%) 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. It will be further understood that terms, including those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
An applicator 100 may be inserted into a body cavity for brachytherapy treatment. The applicator 100 includes a shaft 105 having a first end 110 and a second end 115 opposite the first end 110. In at least one example embodiment, the shaft 105 has a cylindrical shape. In at least one example embodiment, the applicator 100 includes a cap 120 configured to be coupled to the first end 110 of the shaft 105, as will be discussed in relation to
In at least one example embodiment, the applicator 100 includes a base portion 125 at the second end 115 of the shaft 105. In at least one example embodiment, the base portion 125 includes a first section 130, a second section 135, and a third section 140. The second section 135 is positioned between the first section 130 and the third section 140 of the base portion 125. In some example embodiments, the base portion 125 and the shaft 105 are a single unitary piece. In other example embodiments, the base portion 125 may be a separate piece configured to be coupled to the second end 115 of the shaft 105, as will be discussed in relation to
In at least one example embodiment, the second section 135 of the base portion 125 includes an exterior surface 145. The exterior surface 145 may form an angle 150 relative to the axis 155 through the base portion 125. In at least one example embodiment, the angle 150 may be greater than or equal to about 45°.
In at least one example embodiment, the applicator 100 includes a primary channel 160 and one or more secondary channels 165. The primary channel 160 may extend through a center of the applicator 100 through the base portion 125, the shaft 105, and the cap 120. The one or more secondary channels 165 may circumscribe the primary channel 160. For example, the one or more secondary channel 165 may be equidistantly spaced apart about the primary channel 160. In at least one example embodiment, the one or more secondary channel 165 extend from the second section 135 of the base portion 125 (as shown in
In at least one example embodiment, the shaft 105, the cap 120, and/or the base portion 125 of the applicator 100 may comprise a resin or a plastic material. Such materials allow the applicator 100 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 105, the cap 120, and/or the base portion 125 of the applicator 100 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 100 to be checked visually. In at least one example embodiment, surfaces of or materials forming the applicator 100 may also be provided with antibacterial additives such as copper, silver, and/or graphene.
In at least one example embodiment, the first end 110 of the shaft 105 includes a top surface 200. The top surface 200 defines a first groove 205 and a second groove 210. In at least one example embodiment, the first groove 205 circumscribes a first central channel 215 extending through the shaft 105 from the first end 110 to the second end 115. The first central channel 215 may form at least a portion of the primary channel 160, as shown in
In at least one example embodiment, the top surface 200 of the shaft 105 defines one or more holes 220. The one or more holes 220 may be positioned between the first groove 205 and the second groove 210. In at least one example embodiment, the one or more holes 220 comprises three holes. The one or more holes 220 may be spaced equidistantly about a circumference of the top surface 200 of the shaft 105.
In at least one example embodiment, the shaft 105 may include a first plurality of lumens 225 extending from the first end 110 to the second end 115. The first plurality of lumens 225 may form at least a portion of the one or more secondary channels 165 extending through the shaft 105, as shown in
In at least one example embodiment, the cap 120 includes a first side 300 and a second side 305. The first side 300 of the cap 120 includes a mating surface 310 configured to be coupled to the top surface 200 of the shaft 105. In at least one example embodiment, the cap 120 defines a second central channel 315 through a center of the cap 120 and extending from the first side 300 to the second side 305 (as shown in
In at least one example embodiment, the cap 120 includes a first plurality of projections 320 and a second plurality of projections 325 extending from the mating surface 310. The first plurality of projections 320 may circumscribe the second central channel 315. The second plurality of projections 325 may circumscribe the first plurality of projections 320. In at least one example embodiment, the second plurality of projections 325 may be positioned adjacent an outer perimeter of the first side 300 of the cap 120. In at least one example embodiment, the first plurality of projections 320 is configured to engage the first groove 205 of the shaft 105 and the second plurality of projections 325 is configured to engage the second groove 210 such that the cap 120 is secured to the first end 110 of the shaft 105, as shown in
In at least one example embodiment, the cap 120 includes one or more positioning elements 330 extending from the mating surface 310. The one or more positioning elements 330 may be positioned between the first plurality of projections 320 and the second plurality of projections 325. The one or more holes 220 in the top surface 200 of the shaft 105 are configured to receive the one or more positioning elements 330 (as shown in
In at least one example embodiment, the cap 120 defines a plurality of holes 335 extending through at least a portion of the cap 120 from the first side 300 toward the second side 305. The plurality of holes 335 may be positioned between the first plurality of projections 320 and the second plurality of projections 325. The plurality of holes 335 may also be positioned circumferentially about the second central channel 315. The plurality of holes 335 are configured to be coupled to the first plurality of lumens 225 of the shaft 105. For example, the plurality of holes 335 may form at least a portion of the one or more secondary channels 165 extending into the cap 120, as shown in
In at least one example embodiment, the first groove 205 and the second groove 210 of the shaft 105 are configured to receive and engage the first plurality of projections 320 and the second plurality of projections 325 of the cap 120, respectively. In at least one example embodiment, a resin may be applied between the shaft 105 and the cap 120. For example, the resin may be applied to the top surface 200 of the shaft 105 and/or to the mating surface 310 of the cap 120. The resin may also be introduced into the first groove 205, the second groove 210, and/or the one or more holes 220 of the shaft. After applying the resin and connecting the cap 120 to the shaft 104, the resin is cured such that the cap 120 is secured to the shaft 105.
In at least one example embodiment, a resin may be introduced between the cap 120 and the shaft 105 after the cap 102 and the shaft 105 are already connected. For example, the shaft 105 may include an inlet 600 in a side of the shaft adjacent the first end 110 of the shaft 105. The shaft 105 may also include a channel 605 fluidly coupling the inlet 600 with one or more of the holes 220. Resin may be introduced to the one or more holes 220 through the inlet 600 and the channel 605. The resin may also flow from the one or more holes 220 along the top surface 200 of the shaft and the mating surface 310 of the cap 120, and into the first groove 205 and the second groove 210.
In at least one example embodiment, the shaft 105 also includes an outlet 610 opposite the inlet 600. For example, the outlet 610 may be fluidly coupled to the second groove 210 on a side of the shaft 105 opposite the inlet 600. The outlet 610 may also be positioned above the inlet 600 and the channel 605. For example, the outlet 610 may be positioned closer to the first end 110 of the shaft 105 than the inlet 600. In another example embodiment, the outlet 610 may be disposed in the cap 120 adjacent the second plurality of projections 325 and opposite the inlet 600. The outlet 610 may be configured to allow air and excess resin to flow out as resin is introduced through the inlet 600.
In at least one example embodiment, the first section 130 of the base portion 125 includes a mating surface 700. The mating surface 700 may be similar or analogous to the top surface 200 of the shaft 105, as shown in
In at least one example embodiment, the mating surface 700 of the base portion 125 defines one or more holes 720. The one or more holes 720 may extend from the mating surface 700 at least partially into the first section 130 of the base portion 125. In at least one example embodiment, the one or more holes 720 comprises three holes. In at least one example embodiment, the one or more holes 720 may be positioned between the first groove 705 and the second groove 710 and equidistantly spaced apart about the third central channel 715.
In at least one example embodiment, the base portion 125 includes a second plurality of lumens 725. The second plurality of lumens 725 may extend through the first section 130 and the second section 135 of the base portion 125 and form at least a portion of the one or more secondary channels 165, as discussed above with respect to
In at least one example embodiment, the second end 115 of the shaft 105 includes a bottom surface 800. The bottom surface 800 of the shaft 105 may be similar or analogous to the mating surface 310 of the cap 120, discussed above with respect to
In at least one example embodiment, the shaft 105 includes a first plurality of projections 805 and a second plurality of projections 810 extending from the bottom surface 800. The first plurality of projections 805 may circumscribe the first central channel 215. The second plurality of projections 810 may circumscribe the first plurality of projections 805. In at least one example embodiment, the second plurality of projections 810 may be positioned adjacent an outer perimeter of the shaft 105. For example, the second plurality of projections 810 may be between the outer perimeter of the shaft 105 and the first plurality of lumens 225. In at least one example embodiment, the first plurality of projections 805 is configured to engage the first groove 705 of the base portion 125 and the second plurality of projections 810 is configured to engage the second groove 710 of the base portion 125 such that the base portion 125 is secured to the second end 115 of the shaft 105.
In at least one example embodiment, the shaft 105 includes one or more positioning elements 815 extending from the bottom surface 800. The one or more positioning elements 815 may be positioned between the first plurality of projections 805 and the second plurality of projections 810. In at least one example embodiment, the one or more holes 720 in the mating surface 700 of the base portion 125 are configured to receive the one or more positioning elements 815. The one or more positioning elements 815 are configured to align the shaft 105 and the base portion 125 such that the base portion 125 is properly positioned and secured to the shaft 105. In at least one example embodiment, the one or more positioning elements 815 may comprise three positioning elements. In at least one example embodiment, the one or more positioning elements 815 are spaced equidistantly about the first central channel 215. In at least one example embodiment, the one or more positioning elements 815 may comprise a flexible material. The flexible material may enable the one or more positioning elements 815 to be inserted into the one or more holes 720 of the base portion 125 by a snap-fit and/or a form-fit.
In at least one example embodiment, the first groove 705 and the second groove 710 of the base portion 125 are configured to receive and engage the first plurality of projections 805 and the second plurality of projections 810 of the shaft 105, respectively. In at least one example embodiment, a resin may be applied between the base portion 125 and the shaft 105. For example, the resin may be applied to the mating surface 700 of the base portion 125 and/or the bottom surface 800 of the shaft 105 before connecting the base portion 125 and the shaft 105. The resin may also be introduced into the first groove 705, the second groove 710, and/or the one or more holes 720. After the resin is applied and the base portion 125 is connected to the shaft 105, the resin may be cured such that the base portion 125 is secured to the shaft 105.
In at least one example embodiment, the resin may be introduced between the shaft 105 and the base portion 125 after the base portion 125 is coupled to the shaft 105. For example, the base portion 125 may include an inlet 900 for introducing the resin. The inlet may also include a channel 905 configured to fluidly couple the inlet 900 to the one or more holes 720. The shaft 105 may also include an outlet 910 opposite the inlet for allowing air and excess resin to flow out from between the shaft 105 and the base portion 125. In at least one example embodiment, the outlet 910 is fluidly coupled to the second groove 710. The inlet 900, the channel 905, and the outlet 910 may be similar or analogous to the inlet 600, the channel 605, and the outlet 610, as discussed above with respect to
In at least one example embodiment, a plurality of connectors 1000 may be configured to be at least partially inserted into the second plurality of lumens 725 of the base portion 125. For example, the exterior surface 145 of the second section 135 of the base portion 125 may define a plurality of openings 1100. The plurality of openings may be coupled to the second plurality of lumens 725 and configured to receive the plurality of connectors 1000. The plurality of connectors 1000 may comprise the same material as the shaft 105, the cap 120, and/or the base portion 125 of the applicator 100.
In at least one example embodiment, the plurality of connectors 1000 may be coupled to the base portion 125 with a resin. For example, a resin may be applied to each of the plurality of openings 1100 and/or the second plurality of lumens 725 before inserting the plurality of connectors 1000. After inserting the plurality of connectors 1000 into the plurality of openings 1100, the resin may then be cured such that the plurality of connectors 1000 are secured to the base portion 125. In at least one example embodiment, the resin applied to the plurality of openings 1100 and the plurality of connectors 1000 may be cured at the same time the resin applied between the shaft 105 and the base portion 125 and/or the resin applied between the shaft 105 and the cap 120 is cured.
In at least one example embodiment, the plurality of connectors 1000 are configured to be coupled to the second plurality of lumens 725 of the base portion 125, the first plurality of lumens 225 of the shaft 105, and the plurality of holes 335 of the cap 120. For example, the plurality of connectors 1000 may be configured to be coupled to the one or more secondary channels 165 of the applicator 100, as shown in
In at least one example embodiment, the plurality of connectors 1000 may be coupled to a source of radiation 1200. The source of radiation 1200 may include one or more ports 1205 configured to receive one or more wires or cables 1210. For example, a first end 1215 of the cable 1210 may be coupled to one or the ports 1205 and a second end 1220 of the cable 1210 may be coupled to one of the connectors 1000 (as shown in
As shown in
At S1300, in at least one example embodiment, the method includes providing the shaft 105, the base portion 125, and the cap 120. Providing the shaft 105, the cap 120, and the base portion 125 includes forming the shaft 105, the cap 120, and the base portion 125 by additive manufacturing. In at least one example embodiment, the shaft 105 and the base portion 125 may be a single unitary piece that may be formed by additive manufacturing. Additive manufacturing allows the shaft 105, the cap 120, and/or the base portion 125 to be manufactured modularly. Additive manufacturing also allows the applicator 100 to be customizable. For example, the number of channels and the size of the channel, such as the primary channel 160 and the one or more secondary channels 165 may be customized to suit particular treatment or patient needs. Additionally or alternatively, the length, diameter, and/or angle of the applicator 100 may also be customized to suit particular treatment or patient needs. Producing the applicator 100 by additive manufacturing may also reduce costs of manufacturing.
In at least one example embodiment, the method further includes cleaning the shaft 105, the cap 120, and the base portion 125. For example, the shaft 105, the cap 120, and the base portion 125 may be cleaned before connecting the cap 120 to the shaft 105 and before connecting the base portion 125 to the shaft 105.
At S1301, in at least one example embodiment, the method includes connecting the cap 120 to the first end 110 of the shaft 105. Connecting the cap 120 to the shaft 105 may include engaging the first plurality of projections 320 of the cap 120 with the first groove 205 of the shaft 105 and/or engaging the second plurality of projections 325 of the cap 120 with the second groove 210 of the shaft 105. In at least one example embodiment, the connecting the cap 120 to the shaft 105 includes inserting the one or more positioning elements 330 of the cap 120 into the one or more holes 220 of the shaft 105.
As described above in relation to
At S1302, in at least one example embodiment, the method includes connecting the base portion 125 to the second end 115 of the shaft 105. Connecting the base portion 125 to the shaft 105 may include engaging the first plurality of projections 805 of the shaft 105 with the first groove 705 of the base portion and/or engaging the second plurality of projections 810 of the shaft 105 with the second groove 710 of the base portion 125. In at least one example embodiment, connecting the base portion 125 to the shaft 105 may also include inserting the one or more positioning elements 815 of the shaft 105 into the one or more holes 720 of the base portion 125. The method may further include applying a resin between the shaft 105 and the base portion 125. In at least one example embodiment, the resin is applied before connecting the base portion 125 to the shaft 105. In other example embodiments, the resin may be applied after the base portion 125 is connected to the shaft 105. For example, the shaft 105 and/or the base portion 125 may include another inlet, channel, and outlet at the second end 115 of the shaft 105, similar to the inlet 600, the channel 605, and the outlet 610 discussed above with respect to
In at least one example embodiment, the method includes coupling the plurality of connectors 1000 to the base portion 125. For example, the method may include inserting the plurality of connectors 1000 into the plurality of openings 1100 of the base portion 125. The method may further include applying a resin between the base portion 125 and the plurality of connectors 1000, such as introducing the resin into the plurality of openings 1100.
In at least one example embodiment, the method further includes curing the resin such that the cap 120 and the base portion 125 are secured to the shaft 105 and the applicator 100 is formed. The method may further include cleaning the applicator 100 such that any excess resin may be removed and the applicator 100 may be sanitized.
