Anatomical marker and method of marking portion of human body

Abstract

The invention relates to an anatomical marker and a method of marking a portion of a human body. The anatomical marker includes: a housing including a holder disposed within the housing to hold a radioisotope wherein the radioisotope in the holder is replaceable; a top cover enclosing the holder within the housing, where within the top cover and the housing there are provided one or more radioscreening elements forming an enclosure around the holder to enclose the holder with radioisotopes, where the top cover and the radioscreening elements comprise at least one aperture, wherein an ionizing radiation beam emanating from the radioisotope passes through the at least one aperture, and wherein the aperture is fixed by a radioscreening element; a cover that can be removably secured to the top cover; and a handle having a longitudinal axis wherein one end of the handle is configured to support the housing.

Description

Technical Field

[0001] The present invention relates generally to radioactive anatomical markers. In particular, the present invention relates to radioactive anatomical marker devices and related methods for marking organs during medical imaging. Background Art

[0002] Radioisotopes are used in a variety of applications within the medical industry, particularly in the field of medical imaging, where they are used to image the interior of human organs for diagnostic purposes. Non-invasive three-dimensional imaging procedures such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT) utilize radioisotopes to create images based on the radiation emitted by the radioisotope. In these methods, the patient is injected with a dose of the radioisotope in tablet form, which is taken up by cells in the organ of interest.

[0003] Due to their short half-lives, radioactive isotopes undergo radioactive decay. In PET, positron-emitting radioactive isotopes are used. The positrons collide with electrons, annihilating each other, and the released energy, in the form of a gamma-ray beam, acts as a tracer for the target area / organ. A PET scanner, consisting of a ring of radiation detectors, emits a brief pulse of light each time it is struck by a gamma ray emitted from the radioactive isotope. This pulse is compiled to form a three-dimensional image, thereby determining the spatiotemporal distribution of radioactivity within the body part of interest.

[0004] The radioisotopes used in SPECT emit gamma radiation that is directly measured, and a gamma camera is used to acquire multiple 2D images from multiple angles during data acquisition.

[0005] In addition to injecting radioisotopes for PET / SPECT studies, medical personnel can use anatomical markers, such as pen-tip markers, to trace the outlines of anatomical features on a patient for better imaging and to distinguish normal tissue from abnormal tissue (e.g., distinguishing a goiter from the thyroid gland). Pen markers help to trace points of interest during PET / SPECT imaging. The trace of the pen marker will immediately appear on the image display along with the trace of the injected tracer.

[0006] Although pen-tip markers contribute to better imaging, they have limited clinical applications. Pen-tip markers contain Co-57 in a resin matrix at the end of an anodized aluminum rod. Co-57 markers can only be used for PET / SPECT studies if technetium-99 (Tc-99) has been injected as a tracer. If another radioactive isotope were used for scanning, the Co-57 marker would not be of much use because the energy level of Co-57 is only matched to that of Tc-99. Another disadvantage of Co-57 markers is that Co-57 has a short half-life of approximately 270 days, which requires frequent replacement. The use of Co-57 markers imposes additional costs on the client / patient due to their limitations, such as short half-life, compatibility issues, and the high costs involved in importing and handling Co-57 sources. In addition, medical staff must keep these pen-tip markers close to the area of interest during imaging. Due to the small relative distance between personnel and the radiation source and the management of radioisotope waste, the radiation exposure from the pen markers to medical staff is slightly higher.

[0007] In addition, due to the increasing frequency of inspections and photography, a major issue of growing concern is the increasing radiation exposure to medical personnel. The radioactivity levels of radioisotopes used as tracers in imaging processes such as single photon emission computed tomography (SPECT) and positron emission tomography (PET) are harmful to patients and medical personnel. Radioisotopes are toxic and may have physical and / or chemical effects. Due to the short half-life of radioisotopes and the small application dose, the risk-benefit ratio of radiation exposure is acceptable for patients. However, due to the professional activities of medical personnel, continuous and repeated exposure to radiation over long periods of time is a major problem in medical imaging for medical personnel.

[0008] For the reasons stated above and for other reasons described below that will become apparent to one skilled in the art upon reading and understanding this specification, there is a need for anatomical markers for marking organs using various radioactive isotopes. There is also a need for anatomical markers that allow marking to be accomplished with the same injected radioactive isotope tracer. There is a need in the art to reduce exposure, including minimizing the exposure time of personnel, maintaining a distance between personnel and radiation sources, and protecting personnel from the effects of radiation sources. Additionally, there is a need for cost-effective anatomical markers. Additionally, there is a need to reduce the exposure of medical personnel to radioactivity during manual procedures using pen tip markers as additional tracer reagents. There is also a need to improve the quality control of the administration of radioactive isotopes to patients. Furthermore, there is a need to provide anatomical markers that will be an integral part of a scanning system. Summary of the Invention

[0009] Therefore, it is an object of the present disclosure to provide a device and method that overcomes some or all of the shortcomings and deficiencies noted in the prior art. More specifically, the device and method described herein allow medical personnel to utilize a single device for labeling organs with a variety of radioactive isotopes. Additionally, the device and method of the present disclosure allow labeling to be accomplished using the same injected radioactive tracer rather than a sealed Co-57 source.

[0010] For example, an embodiment includes an anatomical marker comprising: a shell comprising: a retainer disposed within the shell to retain a radioactive isotope, wherein the radioactive isotope in the retainer is replaceable; a top cover enclosing the retainer within the shell, wherein one or more radioactive shielding elements forming an enclosure around the retainer are disposed within the top cover and the shell to encapsulate the retainer having the radioactive isotope, wherein the top cover and the radioactive shielding element include at least one aperture, wherein an ionizing radiation beam emitted from the radioactive isotope passes through the at least one aperture, and wherein the aperture is secured by the radioactive shielding element; a cover removably secured to the top cover; and a handle having a longitudinal axis, wherein one end of the handle is configured to support the shell.

[0011] Another exemplary embodiment includes a method for marking a part of a human body, the method comprising: placing a radioactive isotope in a retaining member disposed within a shell; encapsulating the retaining member within the shell by one or more radioactive shielding elements; securing the retaining member within the shell by a top cover and the radioactive shielding element, the top cover and the radioactive shielding element including at least one aperture for an ionizing radiation beam to be emitted from the radioactive isotope, wherein the top cover is secured by the radioactive shielding element; removing the cover and the radioactive shielding element disposed to cover the top cover; and positioning the shell close to the human body by a handle.

[0012] These and other embodiments and various arrangements and aspects will become apparent and more fully understood from the following detailed description and accompanying drawings, which set forth illustrative embodiments that are indicative of the various ways in which the principles of the invention may be employed. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The following figures illustrate by way of example and not limitation. For the sake of brevity and clarity, not every feature of a given structure is labeled in every figure in which the structure appears. The figures use graphic symbols that will be understood by those of ordinary skill in the art to illustrate at least one of the described elements.

[0014] Figure 1is a perspective view of a pen tip marker known in the prior art.

[0015] Figure 2 is an example diagram of a radioactive anatomical marker according to an embodiment of the present invention.

[0016] Figure 3 yes Figure 2 Top view of the components of the radioactive anatomical marker.

[0017] Figure 4 yes Figure 2 Cross-sectional view of a radioactive anatomical marker.

[0018] Figure 5 A method of marking a portion of a human body according to aspects of the present disclosure is illustrated.

[0019] Figure 6 It is through the use of Figure 2 Clinical images obtained using radioactive anatomical markers. DETAILED DESCRIPTION

[0020] The above summary of the present invention is not intended to describe each illustrated embodiment or every possible implementation of the present invention. The following detailed description particularly exemplifies these embodiments.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosed embodiments, the preferred methods, devices, and materials are now described.

[0022] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives will refer to the orientation of the embodiments disclosed in the accompanying drawings. However, it should be understood that the embodiments may employ alternative variations and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0023] According to embodiments of the present invention, radioactive anatomical markers may be designed to reduce exposure to radiation, including minimizing personnel exposure time, maintaining distance between personnel and radiation sources, and protecting personnel from radiation sources.

[0024] According to embodiments of the present invention, radioactive anatomical markers can be designed, wherein the radioisotope used to mark the organ can be the same as the radioisotope used as a tracer in SPECT / PET studies.

[0025] The radioactive anatomical marker may include a holder that holds a radioactive isotope that emits an ionizing radiation beam. The radioactive anatomical marker may include a radioactive shielding material, such as a housing, a radioactive shielding element, and a top cover, wherein the radioactive shielding element encapsulates the holder and the top cover encloses the holder within the housing. The radioactive anatomical marker may include a cap for securing the top cover to the housing and a handle configured to support the housing.

[0026] "Radiation" in the context of the present invention may include ionizing radiation.

[0027] "Radiation" in the context of the present invention may include alpha radiation, beta radiation, gamma radiation, neutron radiation, x-ray radiation, or a combination thereof.

[0028] In the context of the present invention, a "holder" refers to a container that holds a radioactive isotope.

[0029] In the context of the present invention, a "radiation shielding element" refers to a material that can contain and control any potential release of radioactive substances.

[0030] In the context of the present invention, "radioactive emission blocking material" refers to a material having excellent resistance to gamma radiation.

[0031] Figure 1 A prior art pen-tip marker is shown, containing Co-57 in a resin matrix at the end of an anodized aluminum shaft. The pen-shaped shaft screws into a brass cap that shields the active point. These pen-tip markers are used to outline anatomical features on a patient. Physicians or technologists currently use Co-57 pen-tip markers to differentiate goiters from the thyroid gland during SPECT studies.

[0032] Figure 2 Exemplary embodiments of anatomical markers encompassed by the present invention are shown. In various embodiments, Figure 2 The radioactive anatomical marker shown may include a housing, a top cover, a lid, a radioactive shielding element, and a handle. A retainer is disposed within the housing. In one embodiment, the retainer is retained within the housing by one or more shielding elements, which form an enclosure around the retainer. In one embodiment, the top cover encloses the retainer within the housing. In one embodiment, a threaded lid is removably secured to the housing to the top cover. In one embodiment, a handle having a longitudinal axis is configured to support the housing.

[0033] Figure 3 Shown Figure 2 A top view of the components of a radioactive anatomical marker. The housing and radioactive shielding element of the anatomical marker must be sized to fit within a holder. The holder holds the radioactive isotope. A top cover covering the top of the holder and the radioactive shielding element have at least one aperture through which an ionizing radiation beam emitted from the radioactive isotope in the holder passes to trace an anatomical feature of the patient. The radioactive shielding element is disposed on the top cover to seal the aperture of the top cover. A threaded cap is removably secured to the housing.

[0034] Figure 4 yes Figure 2 A cross-sectional view of a radioactive anatomical marker. A holder disposed within a housing is enclosed by one or more shielding elements. The top cover and the top portion of the radioactive shielding element have an aperture covered by the radioactive shielding element. The bottom portion of the top cover is secured to the housing to retain the holder within the housing. A threaded cap retains the radioactive shielding element, which covers the aperture to block ionizing radiation emitted by the radioisotope present in the holder.

[0035] Reference Figure 5 , illustrates an example of a method for marking a portion of a human body by employing a radioactive anatomical marker according to aspects of the present disclosure. At step 501, the method includes placing a radioactive isotope in a holder disposed within a housing. At step 502, the method includes enclosing the holder within the housing by one or more radioactive shielding elements. At step 503, the method includes securing the holder within the housing by a top cover and the radioactive shielding element, the top cover and the radioactive shielding element including at least one aperture for an ionizing radiation beam to be emitted from the radioactive isotope, wherein the top cover is secured by the radioactive shielding element. At step 504, the method includes removing the lid and the radioactive shielding element disposed to cover the top cover. At step 505, the method includes positioning the housing proximate to the human body by a handle.

[0036] Figure 6 A clinical image of an imaging marker according to the present disclosure having multiple imaging markers visible as darker dots where the radioactive anatomical marker of the present disclosure is used to outline anatomical features on a patient. The radioisotope in the anatomical marker device of the present disclosure produces clearer images, which helps to clearly identify the location of abnormal cells / tissue.

[0037] The top cover of the radioactive anatomical marker of the present invention and the radioactive shielding element enclosing the holder have at least one aperture that serves as an active point. The ionizing radiation beam emitted from the radioisotope in the holder passes through the at least one aperture to track the patient's anatomical features. When the radioactive source is not in use, the active point of the radioactive anatomical marker is covered by the radioactive shielding element, which is retained above the top cover by a threaded cap.

[0038] The radiation shielding element employed in this invention acts as a barrier, effectively preventing the release of radioactive material from the sides and top. Its primary purpose is to contain and control any potential release of radioactive material, thereby enhancing safety and environmental protection. Notably, a 2mm opening is provided, designed to allow for the directional emission of gamma rays.

[0039] The radiation shielding element is typically selected from the group of radiation emission blocking materials. The radiation emission blocking materials are not limited and may include, but are not limited to, materials such as tungsten, tungsten alloys, molybdenum, molybdenum alloys, lead, lead alloys, lead-lined wood, leaded glass, polymer composites, ceramic materials, boron-containing polymers, and combinations thereof.

[0040] The radioactive emission blocking material has excellent resistance to gamma radiation, which is emitted in the energy range of approximately 80 KeV to 511 KeV.

[0041] Radioisotopes with relatively short half-lives, such as fluorine-18, technetium-99, carbon-11, copper-64, gallium-67, iodine-123, nitrogen-13, oxygen-15, rubidium-82, thallium-201, chromium-51, iodine-131, iodine-151, iridium-192, phosphorus-32, samarium-153, and yttrium-90, are commonly used in PET and SPECT imaging procedures and other radiotherapy treatments.

[0042] The holder employed in the present invention is safely disposed of after each surgery along with the remaining radioactive waste. The holder can have a diameter sufficient to hold, but not limited to, 0.25 ml, 0.5 ml, 1 ml, and combinations thereof, of radioisotopes. The holder is replaced after each surgery and is made of a material selected from the group consisting of thermoplastic polymers.

[0043] The housing, top cover, lid, and handle are comprised of a material selected from the group consisting of metals, metal alloys, polymeric materials, polymeric composites, and combinations thereof, and in certain embodiments, the sleeve may be comprised of aluminum or polycarbonate.

[0044] The housing of the present invention is configured to safely contain radioactive materials, thereby ensuring that the radioactive materials are safely stored or transported. Typically, the housing will have a total dimension of 340*23*42 (mm) and weigh approximately 110g. The top cover is specially designed to hold one or more radioactive shielding elements securely in place. Additionally, there is a 2mm tapered opening for directional emission. Typically, the total dimension of the top cover is 40*40 (mm) and weighs approximately 50g. The threaded cover is designed to hold the radioactive shielding element covering the orifice securely in place. Typically, the total dimension of the threaded cover is 40*40 (mm) and weighs approximately 10g.

[0045] The radioactive anatomical markers of the present invention will have greater importance in thyroid scanning and thyroid uptake systems. In these systems, a small amount of radioactive tracer that is injected, swallowed, or inhaled as a gas will accumulate in the thyroid gland and release energy. This energy is detected by a gamma camera, a PET scanner, and the data acquired will be fed into a computing system to create an image to receive information related to the structure and function of the thyroid gland. These imaging tests are performed to assess the properties of the gland, diagnose glandular problems, detect abnormal areas, such as lumps (nodules) or inflammation, determine the spread of cancer, and / or assess changes in the gland after surgery, radiotherapy, or chemotherapy. In order to better observe certain areas or structures and / or distinguish between goiter and thyroid, in some cases, anatomical markers are used to trace the outlines of the patient's anatomical features. The radioactive anatomical markers of the present invention can be used to mark the thyroid gland because the device of the present invention allows marking to be completed by the same injected radioactive tracer used for scanning.

[0046] In current practice, Co-57 pen-tip markers are used, which incur additional costs for the customer because they must be purchased separately and are subject to regulatory requirements for annual replacement due to their short half-life. Furthermore, Co-57 cannot be used as a marker for all types of radioisotopes because its energy level does not match that of most radioisotopes used in the field of medical imaging.

[0047] The radioactive anatomical marker of the present invention will help reduce the total cost of ownership for customers because they can utilize a single device for marking organs using various radioisotopes. The radioactive anatomical marker of the present invention also allows marking to be accomplished with the same injected radiotracer used to perform the scan rather than a sealed Co-57 source.

[0048] The above description and examples provide a complete description of the structure and use of the exemplary embodiments. Although certain embodiments have been described above with a certain degree of particularity or with reference to one or more separate embodiments, those skilled in the art may make various changes to the disclosed embodiments without departing from the scope of the invention. Therefore, the various illustrative embodiments of the disclosed devices are not intended to be limited to the specific forms disclosed. Instead, they include all modifications and alternatives that fall within the scope of the claims, and embodiments other than the embodiments shown may include some or all of the features of the depicted embodiments. For example, components may be combined into an integral structure. In addition, where appropriate, aspects of any of the examples in the above examples may be combined with aspects of any of the other examples in the described examples to form other examples having comparable or different properties and solving the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment, or may relate to several embodiments.

Claims

1. An anatomical marker, comprising: A housing, comprising: a holder disposed within the housing to hold a radioactive isotope, wherein the radioactive isotope in the holder is replaceable; a top cover that surrounds the retaining member within the housing, wherein one or more radioactive shielding elements forming an enclosure around the holder are provided within the top cover and the housing to enclose the holder with the radioactive isotope, wherein the top cover and the radiation shielding element include at least one aperture, wherein an ionizing radiation beam emitted from the radioisotope passes through the at least one aperture, and wherein the aperture is secured by the radiation shielding element; a cover removably securable to the top cover; and a handle having a longitudinal axis, Wherein, one end portion of the handle is configured to support the housing.

2. The anatomical marker according to claim 1, wherein The radioisotope disposed in the holder can be the same radioisotope as that used to perform the scan.

3. The anatomical marker according to claim 1, wherein The housing and radiation shielding element are sized to fit within the holder.

4. The anatomical marker according to claim 1, wherein The one or more radiation shielding elements serve as primary radiation shielding material, and wherein the shell and the top cover serve as secondary radiation shielding material.

5. The anatomical marker according to claim 1, wherein The top cover is secured to the housing to seal the retainer within the housing.

6. The anatomical marker according to claim 1, wherein The cover secures the radiation shielding element covering the aperture.

7. The anatomical marker according to claim 1, wherein The material for the retaining member is selected from the group consisting of thermoplastic polymers.

8. The anatomical marker according to claim 1, wherein The materials used for the housing, top cover, lid and handle are selected from the group consisting of metal, metal alloy, polymeric material, polymeric composite material and / or any combination thereof.

9. The anatomical marker according to claim 1, wherein The radiation shielding elements include materials such as tungsten, tungsten alloys, molybdenum, molybdenum alloys, lead, lead alloys, lead-lined wood, leaded glass, polymer composites, ceramic materials, boron-containing polymers, and / or combinations thereof.

10. A method for marking a part of a human body, the method comprising: placing a radioactive isotope in a holder disposed within the housing; enclosing the retainer within a housing by one or more radiation shielding elements; securing the retaining member within the housing by a top cover and the radiation shielding element, the top cover and the radiation shielding element comprising at least one aperture for an ionizing radiation beam to be emitted from a radioisotope, wherein the top cover is secured by the radiation shielding element; removing the lid and the radiation shielding element disposed overlying the top cover; and The housing is positioned close to the human body by a handle.

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