Intraoral marker
A resin-based intraoral marker with a hollow structure and contrast medium injection capability addresses the need for minimally invasive oral markers, facilitating accurate irradiation area identification and enabling stereotactic radiotherapy for early-stage tongue cancer.
Patent Information
- Application Number
- PCT/JP2025/002771
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-05
- Filing Date
- 2025-01-29
- Publication Date
- 2025-08-14
AI Technical Summary
There is a lack of minimally invasive markers suitable for use within the oral cavity for stereotactic radiotherapy, particularly for early-stage tongue cancer, and existing markers are not compatible with stereotactic radiotherapy or suitable for oral use, posing challenges in identifying the appropriate irradiation area and causing invasive issues.
A resin-based intraoral marker with a hollow structure that can be injected with a contrast medium, featuring a protruding portion and an outlet for fluid discharge, allowing easy identification and positioning under imaging devices, and facilitating stereotactic radiotherapy by confirming the irradiation area.
Enables minimally invasive stereotactic radiotherapy by clearly delineating the irradiation area within the oral cavity, supporting various radiation therapies, and reducing the risk of swallowing or aspiration.
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Figure JP2025002771_14082025_PF_FP_ABST
Abstract
Description
Oral marker
[0001] The present disclosure relates to intraoral markers for medical imaging.
[0002] JP 2022-539073 A discloses a marker for brachytherapy, which includes an inner ring made of one or more of copper, brass, gold, silver, or titanium, an outer coating metal inner ring made of one or more of nickel or iron oxide and having a thickness of about 1 μm to about 30 μm, and a central opening having a diameter of about 0.50 mm to about 3.00 mm.
[0003] Approximately 5,000 people in Japan are affected by tongue cancer each year. Half of these cases are in the early stages. There are only a few facilities in Japan that perform brachytherapy for early-stage tongue cancer, and they are unable to meet the needs of patients with early-stage tongue cancer. Therefore, surgical resection is currently the de facto standard treatment. While the five-year survival rate for early-stage tongue cancer with surgical resection exceeds 80%, if the surgical resection is extensive, quality of life (QOL) issues can arise, such as speech impediments, oral discomfort, and aesthetic problems.
[0004] Meanwhile, stereotactic radiotherapy has been found to be effective for early-stage lung cancer, and its range of applicable diseases is gradually expanding. However, stereotactic radiotherapy has not yet been put into practical use in the field of head and neck cancer. Early-stage tongue cancer is surrounded by muscles with high dose tolerance, making it a good candidate for stereotactic radiotherapy, but it is necessary to identify the appropriate irradiation area. For example, it is necessary to irradiate radiation while checking the irradiation area with a marker under X-ray fluoroscopy.
[0005] Because the oral mucosa and tongue are delicate and sensitive organs, it would be highly invasive to implant and permanently leave gold or platinum coils or particles, which have been used in conventional indwelling markers, under the mucosa. Furthermore, there are no markers that can be used inside the oral cavity.
[0006] The marker described in Patent Document 1 is a marker for brachytherapy and is not intended for use in stereotactic radiotherapy, etc. This marker is made of metal, and a contrast agent cannot be injected into it.
[0007] The present disclosure provides a minimally invasive marker that can be used in the oral cavity.
[0008] The intraoral marker according to the first aspect has a hollow main body portion formed from resin, and a contrast medium can be injected into the hollow internal space of the main body portion.
[0009] This intraoral marker, whose main body is made of resin, is minimally invasive to the oral mucosa and can be used intraoral. By injecting a contrast agent into the hollow internal space of the main body and, for example, adhering it around a tumor in the oral cavity, the irradiation area of radiation in stereotactic radiotherapy for the tumor can be easily confirmed, for example, under fluoroscopy with an X-ray device, when using a CT (computed tomography) device, or an MRI (magnetic resonance imaging) device. By irradiating radiation while checking the irradiation area, stereotactic radiotherapy can be performed appropriately within the oral cavity. This intraoral marker can be used not only for stereotactic radiotherapy, but also for other radiation therapies such as proton therapy, particle therapy, and FLASH therapy. The intraoral marker can also be used as a marker for diagnostic purposes.
[0010] A second aspect is an intraoral marker according to the first aspect, which has an inlet for injecting a contrast agent into the internal space, and an outlet through which fluid in the internal space is pushed out when the contrast agent is injected.
[0011] In this intraoral marker, a contrast agent can be injected into the hollow internal space through the contrast agent injection port. When the contrast agent is injected, the fluid in the internal space is pushed out through the outlet, allowing for smooth injection of the contrast agent.
[0012] In a third aspect, in the intraoral marker according to the second aspect, a hollow protrusion made of resin protrudes from the main body, and the inside of the protrusion communicates with the internal space.
[0013] In this intraoral marker, the protruding portion protrudes from the main body, and the interior of the protruding portion is connected to the internal space of the main body, so that a contrast medium can be injected into the internal space of the main body and the protruding portion. Therefore, compared to markers with simple shapes such as circles or squares, the position of the marker is easier to identify when using the X-ray device.
[0014] In a fourth aspect, in the intraoral marker according to the third aspect, the main body portion has an annular portion, and the protrusion protrudes outward from the annular portion.
[0015] This intraoral marker has a ring-shaped portion and a distinctive shape with a protruding portion protruding outward from the ring-shaped portion, making it easier to identify the position of the marker when using the X-ray device, etc., compared to markers with simple shapes such as circles or squares. For example, automatic tracking of the marker using AI (artificial intelligence) is also possible. Furthermore, by tying, for example, surgical thread to the ring-shaped portion, it is possible to prevent the intraoral marker from being accidentally swallowed or aspirated.
[0016] In a fifth aspect, in the intraoral marker according to the fourth aspect, at least a part of the annular portion has a straight portion.
[0017] This intraoral marker can be easily handled by pinching the linear portion provided on at least a part of the annular portion with tweezers, which facilitates the procedure of adhering the intraoral marker to the oral cavity.
[0018] A sixth aspect is the intraoral marker according to any one of the first to fifth aspects, wherein the internal space is filled with a contrast agent.
[0019] Since the internal space of this intraoral marker is filled with a contrast agent, by attaching the intraoral marker to the periphery of a tumor in the oral cavity, the irradiation range of radiation in stereotactic radiotherapy for the tumor can be easily confirmed, for example, under fluoroscopy with an X-ray device, when using a CT (computed tomography) device, or an MRI (magnetic resonance imaging) device. By irradiating radiation while checking the irradiation range, stereotactic radiotherapy can be performed appropriately within the oral cavity.
[0020] According to the present disclosure, it is possible to provide a minimally invasive marker that can be used in the oral cavity.
[0021] (A) is a perspective view of the intraoral marker as seen from the outlet side. (B) is a perspective view of the intraoral marker as seen from the protruding portion side. A cross-sectional view of the intraoral marker. A cross-sectional view of the intraoral marker filled with contrast agent. A perspective view showing the straight portion of the intraoral marker pinched with tweezers. A perspective view showing the intraoral marker with surgical thread tied to the ring-shaped portion. A plan view showing the marker placed around a tongue tumor. A cross-sectional view showing the marker placed around a tongue tumor.
[0022] Hereinafter, embodiments for carrying out the present disclosure will be described with reference to the drawings. Components indicated by the same reference numerals in each drawing are the same or similar components. Note that duplicated explanations and reference numerals may be omitted in the embodiments described below. Furthermore, all drawings used in the following description are schematic, and the dimensional relationships, ratios, etc. of each element shown in the drawings do not necessarily match those in reality. Furthermore, the dimensional relationships, ratios, etc. of each element between multiple drawings do not necessarily match.
[0023] 1 to 3, the intraoral marker 10 according to this embodiment has a hollow main body 12 and a hollow protrusion 14 that protrudes from the main body 12. The main body 12 and the protrusion 14 are integrally formed from resin. The resin may be a resin used in the oral cavity, such as a transparent resin used in intraoral stents. Opaque resins used in dentures and dental treatments may also be used. Furthermore, multiple resins may be combined by two-color molding or the like.
[0024] The main body 12 may have an annular portion 12A. At least a portion of the annular portion 12A may be provided with a linear portion 12B. In this embodiment, the annular portion 12A is substantially D-shaped and has an arc portion 12C and a linear portion 12B. A through portion 12D is formed in the center of the annular portion 12A.
[0025] The protrusion 14 protrudes outward from the annular portion 12A serving as the main body 12. In this embodiment, the protrusion 14 protrudes from the annular portion 12A on the side opposite the straight portion 12B across the through portion 12D. The interior of the protrusion 14 is connected to an internal space 16 of the annular portion 12A, and the internal space 16 is provided inside the protrusion 14 and the annular portion 12A. Note that the protrusion 14 is provided in one location on the annular portion 12, but is not limited thereto and may be provided in multiple locations.
[0026] As an example, the dimensions of the intraoral marker 10 are as follows: overall length is approximately 8 mm, thickness is approximately 2 mm, width of the main body 12 is approximately 5 mm, and width of the protrusion 14 is approximately 3 mm.
[0027] Both sides of the intraoral marker 10 in the thickness direction may be formed flat. In this embodiment, the upper surface 18 and the lower surface 20 are each formed flat. This is to improve the adhesiveness of the intraoral marker 10 to the oral cavity 30 (FIGS. 6 and 7). The shapes of these both surfaces may be cylindrical, donut-shaped, etc.
[0028] A contrast agent 22 can be injected into the hollow internal space 16 in the main body 12 and the protruding portion 14. That is, the intraoral marker 10 is configured as a container for the contrast agent 22. The intraoral marker 10 is provided with an injection port 24 for the contrast agent 22 into the internal space 16, and an outlet 26 through which fluid in the internal space 16 is pushed out when the contrast agent 22 is injected. As an example, the injection port 24 opens at the tip of the protruding portion 14 and communicates with the internal space 16. Furthermore, the outlet 26 opens at the straight portion 12B (annular portion 12A) and communicates with the internal space 16. Note that the positions of the injection port 24 and the outlet 26 are not limited to these and can be changed as appropriate.
[0029] Fig. 2 shows the intraoral marker 10 before the contrast agent has been injected. Fig. 3 shows the intraoral marker 10 after the contrast agent 22 has been injected and filled into the internal space 16. The injection port 24 and the outlet 26 are closed with, for example, resins 34 and 36, respectively. The resins 34 and 36 may be, for example, an adhesive.
[0030] The contrast agent 22 may be, for example, barium sulfate, which blocks X-rays and is visible under X-ray irradiation, or gummies, specifically collagen, fats, gelatin, etc., which exhibit high signals in MRI.
[0031] 1 to 3, in the intraoral marker 10 according to this embodiment, the main body 12 and the protruding portion 14 are formed from resin, so that the intraoral marker 10 is less invasive to the mucous membrane inside the oral cavity 30 and can be used inside the oral cavity 30.
[0032] In this intraoral marker 10, the contrast agent 22 can be injected into the hollow internal space 16 through the injection port for the contrast agent 22. When the contrast agent 22 is injected, the fluid in the internal space 16 is pushed out through the outlet 26, so the injection of the contrast agent 22 can be carried out smoothly even if the intraoral marker 10 is small. If the resin is transparent, it is easy to check the injection status of the contrast agent 22. After the injection of the contrast agent 22, the injection port 24 and the outlet 26 can be blocked with, for example, resins 34 and 36, respectively. This prevents the contrast agent 22 from leaking out.
[0033] 4, the intraoral marker 10 can be easily handled by pinching the linear portion 12B provided on at least a part of the annular portion 12A with tweezers 40. By using tweezers 40 with thin tips, one tip can be inserted into the piercing portion 12D to pinch the linear portion 12B. This facilitates the procedure of adhering the intraoral marker 10 to the oral cavity 30, as shown in FIGS. 6 and 7.
[0034] In FIG. 6 , six intraoral markers 10 injected with contrast agent 22 are attached around a tumor 32A, for example, on a tongue 32 in an oral cavity 30. A medical adhesive can be used to attach the intraoral markers 10 to the oral cavity 30. By positioning the intraoral markers 10 in this manner, the irradiation range of radiation for stereotactic radiotherapy of the tumor 32A can be easily confirmed, for example, under fluoroscopy with an X-ray device, when using a CT (computed tomography) device, or an MRI (magnetic resonance imaging) device. By irradiating radiation while checking the irradiation range, stereotactic radiotherapy can be performed appropriately within the oral cavity 30. This intraoral marker 10 can also be used in stereotactic radiotherapy, proton therapy, particle therapy, and FLASH therapy. The intraoral marker can also be used as a marker for diagnostic purposes. Note that the direction of the protrusions 14 of each intraoral marker 10 in Figure 6 does not have to be particularly aligned, but it is desirable to arrange each intraoral marker 10 so that the main body 12 and protrusions 14 of the intraoral marker 10, i.e., the characteristic shape, can be seen in a planar view.
[0035] 7, an intraoral spacer 42 is used to fix the position of the tumor 32A. The intraoral spacer 42 is fitted to the upper and lower teeth 44, 46, respectively, and holds the tongue 32 by suction or by pinching it between the intraoral spacer 42. The intraoral marker 10 may be adhered to the tongue 32 or to the mucous membrane surrounding the tongue 32.
[0036] The intraoral marker 10 has a ring-shaped portion 12A and a characteristic shape in which the protrusion 14 protrudes outward from the ring-shaped portion 12A, so that the position of the intraoral marker 10 is easier to identify when using the X-ray device, etc., compared to markers with simple shapes such as circles or squares. It also becomes possible to automatically track the intraoral marker 10 using, for example, AI (artificial intelligence) when the tongue 32 having the tumor 32A moves.
[0037] Furthermore, as shown in FIG. 5, by tying, for example, a surgical thread 38 to the loop portion 12A, it is possible to prevent the intraoral marker 10 from being accidentally swallowed or aspiration.
[0038] As described above, this embodiment can provide a minimally invasive marker that can be used inside the oral cavity 30. This makes it possible to provide an improved intraoral marker.
[0039] [Other Embodiments] Although one example of an embodiment of the present disclosure has been described above, the embodiment of the present disclosure is not limited to the above, and it goes without saying that various modifications can be made without departing from the spirit of the present disclosure.
[0040] The annular portion 12A is generally D-shaped and has an arc portion 12C and a straight portion 12B, but the annular portion 12A is not limited to the arc portion 12C and may be, for example, elliptical, polygonal, irregular, or a combination thereof. Also, the annular portion 12A may not have the straight portion 12B.
[0041] Although the through-hole 12D is formed in the center of the annular portion 12A in the above embodiment, the present invention is not limited to this, and for example, a recess (not shown) that does not penetrate the annular portion 12A may be formed. Also, the annular portion 12A may have no through-hole 12D or recess.
[0042] The shape of the protrusion 14 is not limited to a straight cylindrical shape, but may be any shape, such as curved, bent, or flared, as long as it improves the visibility of the intraoral marker 10.
[0043] Although the main body 12 has the annular portion 12A in the above embodiment, the main body 12 is not limited to this and may have a non-annular C-shaped portion, U-shaped portion, or the like (not shown). In this case, the protrusion 14 may protrude outward from the C-shaped portion or U-shaped portion.
[0044] Although the intraoral marker 10 has the protruding portion 14 in the above embodiment, it may have a configuration without the protruding portion 14 .
[0045] The disclosure of Japanese Patent Application No. 2024-015752, filed on February 5, 2024, is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards mentioned herein are incorporated herein by reference to the same extent as if each individual document, patent application, and technical standard was specifically and individually indicated to be incorporated by reference.
Claims
1. An intraoral marker having a hollow body made of resin, in which a contrast medium can be injected into the hollow internal space of the body.
2. An intraoral marker according to claim 1, comprising: an inlet for injecting a contrast medium into the internal space; and an outlet through which fluid in the internal space is pushed out when the contrast medium is injected.
3. An intraoral marker according to claim 2, wherein a hollow protruding portion made of resin protrudes from said main body portion, and the inside of said protruding portion communicates with said internal space.
4. An intraoral marker according to claim 3, wherein the main body has an annular portion, and the protrusion protrudes outward from the annular portion.
5. The intraoral marker according to claim 4, wherein at least a part of the annular portion has a straight portion.
6. An intraoral marker according to any one of claims 1 to 5, wherein the internal space is filled with a contrast agent.
Citation Information
Patent Citations
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