Radiation therapy reference marker
By designing alternating first and second segments in the reference positioning markers, and setting a deformable segment in the second segment, the problems of friction and jamming during implantation were solved, achieving higher positioning accuracy and stability.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- CAM TOM SAM LLC
- Filing Date
- 2021-10-06
- Publication Date
- 2026-06-23
AI Technical Summary
Existing reference positioning markers are prone to inaccurate positioning due to increased friction or getting stuck inside the needle during implantation, which affects the effectiveness of radiotherapy.
Design a radiotherapy reference positioning marker comprising a first segment and a second segment arranged alternately along a longitudinal axis, wherein the second segment is provided with a deformable segment to control the deformation to occur at a predetermined position between adjacent first segments, ensuring linear alignment during implantation.
This reduces the risk of friction and entrapment, improves the stability and reliability of the positioning markers in the tissue, and ensures the accuracy of radiotherapy.
Smart Images
Figure CN116096462B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a radiotherapy reference positioning marker, particularly a marker suitable for implantation into tissue using a hollow needle, and which is adapted to form an expanded and entangled sphere when implanted into tissue. Background Technology
[0002] During treatment, such as radiation therapy for cancer, treatment of the target area is often repeated over time. Radiation equipment localization is typically used to calibrate the radiation equipment for the specific target area, based on imaging systems such as computed tomography (CT). Imaging systems can be combined and include, for example, X-ray imaging, magnetic resonance imaging (MRI), and positron emission tomography (PET), ultrasound imaging, or any other suitable imaging techniques. The accuracy of radiation equipment calibration / localization is crucial to ensuring the effectiveness of radiation therapy and minimizing unwanted effects on healthy tissues.
[0003] Other applications include guidance during surgical procedures, where surgeons need to navigate their tools during surgery.
[0004] Reference positioning markers are used in implanted tissue to assist in the calibration / positioning of radiation equipment and / or in providing tools for surgeons. These markers typically indicate the location of a target area within the patient's body and allow for improved calibration / positioning of radiation equipment as radiation therapy is repeated over time.
[0005] US Patent 9579160 discloses a prior art reference positioning marker suitable for implantation into tissue using a hollow needle. This reference positioning marker addresses several challenges associated with other reference positioning markers, such as facilitating simple implantation, providing sufficient quality to deliver good contrast in images produced by different types of imaging systems, minimizing the risk of bleeding and infection, and ensuring that the reference positioning marker remains largely in the same location in the body over time.
[0006] However, the aforementioned prior art markings have the following drawbacks: the reference positioning mark can be deformed to increase friction in the hollow needle used to implant the reference positioning mark, or even cause the reference positioning mark to get stuck inside the needle.
[0007] Therefore, improved reference positioning markers are needed.
[0008] Purpose of the invention
[0009] The purpose of the embodiments of the present invention is to provide a solution that mitigates or solves the above-mentioned disadvantages and problems. Summary of the Invention
[0010] The above and other objectives are achieved through the subject matter described herein. Other advantageous embodiments of the invention are also defined herein.
[0011] According to a first aspect of the invention, the object of the invention is achieved by a radiotherapy reference positioning mark suitable for implantation into tissue using a hollow injection needle, wherein the mark comprises an elongated object having a longitudinal axis and having a cross section perpendicular to the longitudinal axis, suitable for fitting within the inner diameter of the needle, wherein the mark comprises a plurality of first segments having a first cross section and one or more second segments having a second set of cross sections, wherein the area of the first cross section is selected to be relatively larger than the area of the second set of cross sections, and wherein the first and second segments are arranged alternately to each other along the longitudinal axis, wherein one or more second segments are provided with one or more deformable segments, said one or more deformable segments being adapted to ensure that any deformation of the plurality of second segments when positioned inside the needle occurs in predetermined positions between adjacent first segments, such that when the mark encounters resistance during implantation into the tissue, the plurality of first segments remain linearly aligned in the injection needle.
[0012] The advantage of the invention according to the first aspect is that it at least reduces or even eliminates the risk of deformation leading to reduced friction and / or the risk of the reference positioning mark getting stuck inside the needle.
[0013] In one embodiment of the first aspect of the invention, one or more deformable segments are centered between correspondingly adjacent first segments, and each deformable segment includes the smallest region of the second set of cross-sectional areas.
[0014] In one embodiment of the first aspect of the invention, the minimum region is also centered on the longitudinal axis.
[0015] In one embodiment of the first aspect of the invention, one or more deformable segments are formed as curved portions that extend from the outer surface of the end of a corresponding second segment in a direction toward the longitudinal axis.
[0016] In one embodiment of the first aspect of the invention, the curved portion has a bending radius equal to or greater than half the diameter of the circle enclosing the contour of the first cross section.
[0017] In one embodiment of the first aspect of the invention, one or more deformable segments include a single deformable segment formed as an elongated element having a weakened recess on the side of the deformable segment facing the longitudinal axis.
[0018] In one embodiment of the first aspect of the invention, one or more deformable segments include a single deformable segment formed as an elongated element with a sharp crease, wherein the crease has a direction perpendicular to the longitudinal axis from a cylindrical shape formed by the outer surface of the first segment.
[0019] In one embodiment of the first aspect of the invention, the plurality of second segments further include two anchoring segments, each anchoring segment being arranged between any adjacent first segment and one or more deformable segments, wherein the anchoring segment includes a cross-section that ranges from an area equal to the area of the first cross-section at the end of the corresponding second segment to a reduced area of one or more deformable segments.
[0020] In one embodiment of the first aspect of the invention, the marking includes a density of at least 10 g / cm³. 3 The first material constitutes at least 90% of the volume of the mark, wherein the mark includes a second material that is magnetic and constitutes at most 10% of the volume of the mark, and wherein the mark includes an alloy or particulate mixture having the first material and the second material.
[0021] In one embodiment of the first aspect of the invention, the markings include a first segment of two to fifteen and a second segment of one to fourteen.
[0022] An advantage of the implementation according to the first aspect is that any deformation of the plurality of second segments when positioned inside the needle occurs in predetermined positions between adjacent first segments, such that the plurality of first segments remain linearly aligned in the injection needle when the marker encounters resistance during implantation into the tissue.
[0023] Other applications and advantages of the embodiments of the present invention will become apparent from the following detailed description. Attached Figure Description
[0024] Figures 1A to 1C The reference positioning marks of the prior art are shown.
[0025] Figure 2A The illustration shows the reference positioning markers before implantation into the tissue.
[0026] Figure 2B The illustration shows the reference positioning markers after implantation into the tissue.
[0027] Figure 3A The illustration shows an unwanted deformation of the reference positioning mark in the prior art.
[0028] Figure 3B Other examples of unwanted variations of prior art reference positioning marks are illustrated.
[0029] Figures 4A to 4B The illustration shows the inventive concept of reference locating mark 5 according to one or more embodiments of the present disclosure.
[0030] Figures 5A to 5B A side view of a reference positioning mark according to one or more embodiments of the present disclosure is shown.
[0031] Figures 6A to 6B The diagram shows a deformed section formed as a bend according to one or more embodiments of the present disclosure.
[0032] Figures 7A to 7B A deformed section including a weakened recess is shown according to one or more embodiments of the present disclosure.
[0033] Figures 8A to 8B A detailed side view of a deformed section 22 including a sharp crease CR according to one or more embodiments of the present disclosure is shown.
[0034] Figures 9A to 9C Different cross sections of a first segment according to one or more embodiments of the present disclosure are shown.
[0035] Figures 10A to 10B A first section of a reference positioning mark provided with a reflector element is shown according to one or more embodiments of the present disclosure.
[0036] By considering the following detailed description of one or more embodiments, a more comprehensive understanding of embodiments of the invention and an appreciation of its additional advantages will be provided to those skilled in the art. It should be understood that the same reference numerals are used to identify the same elements illustrated in one or more figures. Detailed Implementation
[0037] The word "or" in this specification and the corresponding claims should be understood to encompass the mathematical OR of "and" and "or", and should not be understood as XOR (exclusive OR). The indefinite article "a" in this disclosure and claims is not limited to "a" and can also be understood as "a or more", i.e., a plurality of.
[0038] In this disclosure, the term "radiotherapy reference positioning mark," used interchangeably with the term "marker" herein, refers to an arrangement structure suitable for assisting in the calibration / positioning of a radiation device configured to deliver radiotherapy to a target area in a patient's tissue. The reference positioning mark is suitable for implantation in the tissue of a patient (human or animal). The reference positioning mark is suitable for indicating the location of a target area in an image of the patient's body and allows for improved calibration / positioning of the radiation device as radiotherapy is repeated over time. An example of a radiotherapy reference positioning mark is shown in US9579160.
[0039] This disclosure discloses a radiotherapy reference positioning marker adapted for implantation into tissue using a hollow needle by constructing the marker as an elongated object suitable for fitting within the inner diameter of a needle. This facilitates simple implantation in the body.
[0040] In this disclosure, the terms "hollow injection needle" and / or "needle" are used interchangeably and refer to, for example, a hypodermal injection needle.
[0041] In this disclosure, the term "cross section" means a non-empty intersection with the longitudinal axis of an elongated object or with a plane perpendicular to a first or second segment as disclosed herein. In other words, creating a cross section by cutting the object into slices results in multiple parallel cross sections.
[0042] The terms “millimeters” and “mm” in this disclosure are used interchangeably.
[0043] The marker is formed by alternating first and second segments along the longitudinal axis, which allows the marker to remain linearly aligned in the injection needle and then form an entangled and expanded sphere of the first and second segments as it leaves the needle and is implanted into the patient's tissue.
[0044] The marker comprises multiple first segments having a first cross-section and one or more second segments having a second set of cross-sections. The area of the first cross-section is selected to be relatively larger than the area of the second set of cross-sections. This facilitates or ensures that the marker bends / flips in one or more second segments when it encounters resistance during its implantation into the tissue.
[0045] This invention ensures that any deformation of the plurality of second segments when positioned inside the needle and subjected to forces along or parallel to the longitudinal axis occurs at predetermined positions between adjacent first segments, such that the plurality of first segments remain linearly aligned along the longitudinal axis within the injection needle when resistance is encountered during implantation into the tissue. This is ensured by providing one or more second segments, each of which is provided with one or more deformable segments adapted to deform at one or more predetermined positions.
[0046] In other words, if the force is applied along the longitudinal axis, any deformation of one or more second segments is controlled such that the multiple first segments remain aligned along the longitudinal axis when the multiple first segments are positioned in the injection needle, and the first segments are still allowed to tilt and / or fold and form tangled and expanded spheres after exiting the needle.
[0047] The deformation of one or more second segments is typically controlled by making the one or more second segments weaker than the plurality of first segments, and by positioning one or more of the weakest points of each of the one or more second segments such that the plurality of first segments remain linearly aligned along the longitudinal axis in the injection needle when the marker encounters resistance during implantation into the tissue. Without departing from this disclosure, one or more deformed segments may be formed using different shapes, such as circular, semi-circular, circular segments, elliptical, triangular, or star-shaped.
[0048] The application of reference positioning markers in this article includes:
[0049] Used as a marker in breast tissue to guide surgeons when removing breast tumors.
[0050] Used in endoscopic image-guided surgery; used in image-guided robotic surgery.
[0051] Used in image-guided high-intensity focused ultrasound (HIFU).
[0052] Used in image-guided radiofrequency ablation (RFA) and microwave ablation (MWA).
[0053] Use within the marked area of cryoablation.
[0054] Used as a biopsy marker (simply marking the location where a biopsy is performed for future reference);
[0055] The above list is not exhaustive, and other applications are envisioned.
[0056] Figure 1AA side view of a prior art reference positioning mark 5 is shown. Mark 5 is formed by alternating first segments 1 and second segments 2 arranged along a longitudinal axis CL. This allows the mark to maintain linear alignment in the injection needle and then allows it to tilt and / or fold as it leaves the needle and is implanted into the patient's tissue to form an entangled and expanded sphere of the first and second segments. The mark includes a plurality of first segments 1 having a first cross-section AA and one or more second segments 2 having a second set of cross-sections BB. The area of the first cross-section AA is selected to be relatively larger than the area of the second set of cross-sections BB. This facilitates or ensures that when the mark 5 encounters resistance during implantation into the tissue, i.e., when forces acting along the longitudinal axis provide resistance during the implantation of the mark 5, the mark 5 bends / folds in one or more of the second segments 2. The reference positioning mark 5 has a total length L. TOT This ranges from approximately 10mm to 30mm. It should be understood that L... TOT It can be selected to any suitable length related to the length of the hollow needle used for implantation marker 5. The preferred total length L TOT It is 20 mm or in the range of [5 mm to 35 mm].
[0057] In one example, the markings consist of ten first segments, nine second segments, and have a total length L of 20 mm. TOT In one example, the markings consist of fifteen first segments, fourteen second segments, and have a total length L of 30 mm. TOT In another example, the marking comprises two first segments, one second segment, and has a total length L of 3 mm. TOT .
[0058] Figure 1B A detailed side view of a prior art reference positioning mark 5 is shown. As described above, mark 5 typically includes a plurality of first segments 1 having a first cross-section AA and at least one or more second segments 2 having a second set of cross-sections BB. A first region AR1 of the first cross-section AA is selected to be relatively larger than a second region AR2 of the second set of cross-sections BB; for example, the first region AR1 of the first cross-section AA is selected to be ten times the size of the second region AR2 of the second set of cross-sections BB. In embodiments using circular cross-sections, the diameter relationship between the first segment 1 and the second segment 2 can be approximately 6:1. In other words, the second set of cross-sections BB typically has a second region AR2 that is within the range of [1% to 10%] of the first region AR1 of the first cross-section AA.
[0059] In one example, the diameter of the first segment 1 is between 0.2 mm and 0.7 mm, and the diameter B2 of the second segment 2 is between 0.025 mm and 0.12 mm. In a preferred embodiment, the diameter of the first segment 1 is 0.28 mm, and each first segment 1 has a diameter of 0.0615 mm. 2 The first region is AR1. The diameter of the second segment is 0.05 mm, and each second segment has a diameter of 0.002 mm. 2 The second region AR2. In another preferred embodiment, the diameter of the first segment 1 is 0.2 mm. The diameter of the second segment is 0.03 mm. Furthermore, the first segment 1 has a length L1 of about 2 mm, and the second segment 2 has a length L2 of about 1 mm.
[0060] Figure 1C Cross-sectional views of cross sections AA and BB of a prior art reference positioning mark 5 are shown. As described above, mark 5 typically includes a plurality of first segments 1 having a first cross section AA and at least one or more second segments 2 having a second set of cross sections. A first region AR1 of the first cross section AA is selected as a second region AR2 that is relatively larger than the second set of cross sections.
[0061] Figure 2A The illustration shows a reference positioning mark 5 prior to implantation into the tissue. The reference positioning mark 5 is positioned inside the hollow injection needle 4 and is prepared for implementation in the patient's tissue. The mark 5 comprises an elongated object having a longitudinal axis CL. This elongated object includes multiple first segments 1 having a first cross-section AA and one or more second segments 2 having a second set of cross-sections BB. The area of the first cross-section AA is selected to be relatively larger than the area of the second set of cross-sections BB. The first segments 1 and the second segments 2 are arranged alternately along the longitudinal axis CL. When the mark 5 is positioned inside the needle 4 prior to implantation into the tissue, the longitudinal axis CL of the mark 5 substantially corresponds to the longitudinal axis of the hollow injection needle 4. A mandrel 3 is arranged to push the mark in the direction of the arrow.
[0062] Figure 2B The illustration shows the reference positioning mark 5 after implantation into the tissue. The reference positioning mark 5 after implementation in the patient's tissue is shown. As described above, the mark 5 comprises a plurality of first segments 1 and one or more second segments 2, which, upon being propelled from the hollow injection needle 4 by the mandrel 3, fold or wrinkle at the second segments into a three-dimensional structure having a diameter / cross-sectional area larger than that of the needle 4 and the resulting tissue channel 31, or having a diameter / cross-sectional area at least larger than the initial cross-sectional area of the mark 5. In other words, the mark 5, upon implantation into the tissue through the tip of the needle 4, forms an entangled and expanded sphere 5b of the first segments 1 and the second segments 2.
[0063] The marker 5 has the advantage of firmly embedding itself into the tissue because, after forming an entangled and expanded sphere 5b, the marker 5 will expand and have a larger diameter than the tissue channel 31 formed by the hollow injection needle 4. This has the advantage of minimizing the risk of the marker 5 changing position over time. It also has the advantage that a relatively fine needle can be used, leaving a smaller tissue channel, because the marker can have a fairly small diameter when unfolded and expand upon realization, and therefore the marker is clearly visible in MRI, X-ray, or CT images when folded. In other words, the foldable marker 5 can therefore be implanted using a relatively small diameter needle 4, which minimizes trauma to the patient, and this can even be done without general anesthesia. Therefore, the time between marker placement and radiation therapy can be reduced or even eliminated.
[0064] Figure 3A The illustration shows an unwanted deformation of the prior art reference positioning mark 5. When the mark 5 is pushed out of the needle 4 by the mandrel 3, the bending resistance of the tissue and / or the second segment will generate a force F, which acts in the opposite direction to the force applied by the mandrel 3 attempting to push the mark out of the tip of the needle 4.
[0065] If the force F exceeds a certain limit, the marker will deform when it encounters resistance / force F during implantation into the tissue, and the first segment 1 and the second segment 2 will no longer maintain linear alignment within the injection needle 4. This will result in increased friction between the marker 5 and the inside of the needle 4, or even complete jamming, causing the marker to become stuck inside the needle 4.
[0066] Figure 3B An example of an unwanted deformation of the prior art reference positioning mark 5 is illustrated. It should be understood that any deformation may occur that causes the first segment 1 and the second segment 2 to no longer maintain linear alignment in the injection needle 4.
[0067] The inventor has solved this problem in the solution disclosed below. The inventor has already... Figures 1A to 3B The existing reference positioning mark 5 disclosed herein is improved into the improved reference positioning mark 5 disclosed below.
[0068] Figures 4A to 4B The illustration shows the inventive concept of reference locating mark 5 according to one or more embodiments of the present disclosure. Figure 4AThe image shows an improved reference positioning mark 5 before deformation and positioned within needle 4. One or more second segments are provided with one or more deformable segments 22, which ensure that any deformation of the one or more second segments when positioned inside the needle occurs at predetermined positions between adjacent first segments, such that the plurality of first segments remain linearly aligned within the injection needle when the mark encounters resistance during implantation into the tissue. Figure 4B The image shows an improved reference positioning mark 5 after deformation and positioning in needle 4.
[0069] The reference positioning marker 5 presented herein can be used in radiotherapy and / or microwave therapy and / or cryosurgery and / or ultrasound therapy.
[0070] Figure 5A A general side view of a reference positioning mark 5 according to one or more embodiments of the present disclosure is shown. The improved reference positioning mark 5 comprises an elongated object having a longitudinal axis CL. The elongated object includes a plurality of first segments 1 and one or more second segments 2. It should be understood that the minimum configuration of the mark 5 includes two first segments and one second segment 2. The first segments 1 and the second segments 2 are arranged alternately along the longitudinal axis CL. Any suitable number of first segments and second segments can be included within the elongated object of the mark 5. When the mark 5 is positioned in a hollow injection needle 4 (not shown), the longitudinal axis CL of the mark 5 substantially corresponds to the longitudinal axis of the hollow injection needle 4.
[0071] Figure 5B A detailed side view of a reference positioning mark 5 according to one or more embodiments of the present disclosure is shown. A vertical dotted line marks the section between a first segment 1 and a second segment 2. The first segment may have a first length L1 of, for example, about 2 mm, and the second segment 2 may have a second length L2 of, for example, about 1 mm.
[0072] In one example, the first segment has a first length L1 of 1.2 mm and the second segment has a second length L2 of 0.8 mm.
[0073] Each of the multiple first segments 1 typically has a generally consistent first cross section AA, for example, shaped like a circle, ellipse, triangle, or star. One or more second segments 2 have a second set of cross sections BB, CC, DD, EE, FF. The area of the first cross section is typically selected to be relatively larger than the area of the second set of cross sections, thereby ensuring that the deformation / folding / bending of the mark 5 occurs in one or more second segments 2.
[0074] In other words, by ensuring that at least some of the regions of the second set of cross sections BB, CC, DD are relatively smaller than the region of the first cross section AA, mark 5 will deform / fold / wrinkle at one or more points of the second segment 2 where the bending resistance is minimal when subjected to a force approximately along the longitudinal axis CL.
[0075] In one embodiment, a radiotherapy reference positioning mark 5 is provided, suitable for implantation into tissue using a hollow injection needle 4. The reference positioning mark 5 comprises an elongated object having a longitudinal axis CL and cross sections AA, BB, CC, DD, EE, FF perpendicular to the longitudinal axis CL, adapted for fitting within the inner diameter DI of the needle 4. The mark 5 is configured to form an entangled and expanded sphere 5b of first segments 1 and second segments 2 upon implantation into tissue by exiting the needle (4). Furthermore, the mark 5 includes a plurality of first segments 1 having a first cross section AA and one or more second segments 2 having a second set of cross sections BB, CC, DD, EE, FF. The area of the first cross section AA is selected to be relatively larger than the area of the second set of cross sections BB, CC, DD, EE, FF. Furthermore, the first segments 1 and the second segments 2 are arranged alternately along the longitudinal axis CL. In this embodiment, one or more second segments 2 are provided with one or more deformable segments 22, which are adapted to ensure that any deformation of the plurality of second segments when positioned inside the needle occurs in a predetermined position between adjacent first segments, such that the plurality of first segments remain linearly aligned in the injection needle when the marker encounters resistance during implantation into the tissue.
[0076] As described above, by ensuring that the area of the second set of cross sections BB, CC, DD, EE, FF is relatively smaller than the area of the first cross section AA, the marker 5 will deform / fold / wrinkle at one or more points of minimum bending resistance of the second section 2, i.e., at the deformation section 22, when subjected to a force approximately along the longitudinal axis CL.
[0077] Figure 6A A detailed side view of a deformable segment 22 formed as a bend according to one or more embodiments of the present disclosure is shown. In one embodiment, one or more deformable segments comprise a single deformable segment. In one embodiment, the deformable segment 22 is centered between corresponding adjacent first segments AJ1, AJ2, and includes the smallest region AR2 located at section BB among the regions AR2, AR3, AR4, AR5, AR6 of the second set of cross-sections BB, CC, DD, EE, FF.
[0078] In one embodiment, the minimum region AR2 at section BB is centered between the corresponding adjacent first segments AJ1 and AJ2. Alternatively or additionally, the minimum region AR2 is centered on the longitudinal axis CL. In other words, the geometric center / mass center of region AR2 at section BB intersects the longitudinal axis CL.
[0079] These implementations have the advantage that any deformation of the plurality of second segments when positioned inside the needle occurs in the middle between adjacent first segments AJ1, AJ2, such that the plurality of first segments remain linearly aligned in the injection needle when the marker encounters resistance during implantation into the tissue.
[0080] In one embodiment, one or more deformable segments are formed as bends that extend from the outer surfaces of the ends E1, E2 of the respective second segments in a direction toward the longitudinal axis CL.
[0081] In one embodiment, the bend has a bending radius R, which is equal to or greater than half the diameter of the circle CK that encloses the outline of the first cross-section AA.
[0082] In one embodiment, each of the plurality of second segments 2 further includes two anchoring segments 21A to 21B, respectively arranged between any adjacent first segments AJ1, AJ2 and one or more deformable segments 22. Specifically, the first anchoring segment 21A is shown located between section EE and section CC, and the second anchoring segment 21B is shown located between section DD and section FF. The first anchoring segment 21A has a length L21A along the longitudinal axis CL. The second anchoring segment 21B has a length L21B along the longitudinal axis CL.
[0083] In one example, the length L21A of the first anchoring section 21A is equal to the length 21B of the second anchoring section 21B, and the length L21A is in the range of 0.10 mm to 0.12 mm.
[0084] Figure 6B An exemplary second set of cross-sections of the second segment according to one or more embodiments of the present disclosure is shown. As can be seen, the second segment 2 connects to the leftmost adjacent first segment AJ1 at cross-section EE at the first end E1 (the leftmost end in the figure), and connects to the rightmost adjacent first segment AJ2 at cross-section FF at the second end E2 (the rightmost end in the figure). The minimum region AR2 at cross-section BB is centered between the corresponding adjacent first segments AJ1 and AJ2.
[0085] The third section CC formed between section EE and section BB has a third region AR3, which is relatively smaller than the first region AR1 of the first section AA and relatively larger than the region of section BB centered between the corresponding adjacent first segments AJ1 and AJ2.
[0086] The fourth section DD formed between section FF and section BB has a fourth region AR4, which is relatively smaller than the first region AR1 of the first section AA and relatively larger than the region of section BB that is centered between the corresponding adjacent first segments AJ1 and AJ2.
[0087] The advantage of this is that any deformation of the multiple second segments when positioned inside the needle occurs at the cross section BB in the middle between the adjacent first segments AJ1 and AJ2, so that the multiple first segments remain linearly aligned in the injection needle when the marker encounters resistance during implantation into the tissue.
[0088] exist Figure 6B In the example shown, the second set of cross sections BB, CC, DD, EE, FF of the second segment are shown as circular cross sections, and the first cross section AA is shown as a circle. It should be understood that the first segment 1 can have any suitable uniform first cross section AA, for example, shaped like a circle, ellipse, triangle, or star. Similarly, the second set of cross sections BB, CC, DD, EE, FF can be suitable uniform first cross section AA cross sections, i.e., circular, elliptical, triangular, or star-shaped cross sections.
[0089] Figure 7A A detailed side view of a deformable segment 22 including a weakened recess WI according to one or more embodiments of the present disclosure is shown. In one embodiment, the one or more deformable segments comprise a single deformable segment. In one embodiment, each of the one or more deformable segments is formed as an elongated element having a weakened recess WI on the side of the deformable segment facing the longitudinal axis CL. The weakened recess WI is generally centered between correspondingly adjacent first segments AJ1, AJ2.
[0090] The effect of this is that when the deformable segment 22, including the weakened recess WI, is subjected to a force along the longitudinal axis CL and is still positioned in the needle 4, the deformable segment 22 will fold over at the weakened recess WI and ensure that the multiple first segments remain linearly aligned in the injection needle when the marker encounters resistance during implantation into the tissue.
[0091] In one embodiment, each of the plurality of second segments 2 further includes two anchoring segments 21, each arranged between any adjacent first segments AJ1, AJ2 and one or more deformable segments 22. Specifically, a first anchoring segment 21A is shown located between section EE and section CC, and a second anchoring segment 21B is shown located between section DD and section FF. The first anchoring segment 21A has a length L21A along the longitudinal axis CL. The second anchoring segment 21B has a length L21B along the longitudinal axis CL.
[0092] In one example, the length L21A of the first anchoring section 21A is equal to the length 21B of the second anchoring section 21B, and the length L21A is in the range of 0.10 mm to 0.12 mm.
[0093] Figure 7B An exemplary second set of cross-sections of a second section according to one or more embodiments of the present disclosure is shown. Relative to Figure 6B It also describes the region of the second set of cross sections in the second segment.
[0094] Figure 8A A detailed side view of a deformable segment 22 including a sharp crease CR according to one or more embodiments of the present disclosure is shown. In one embodiment, one or more deformable segments include a single deformable segment 22. In one embodiment, each of the one or more deformable segments is formed as an elongated element provided with a sharp crease, wherein the crease has a direction perpendicular to the longitudinal axis (CL) from a cylindrical shape formed by the outer surface of the first segment.
[0095] In one embodiment, each of the plurality of second segments 2 further includes two anchoring segments 21, each arranged between any adjacent first segments AJ1, AJ2 and one or more deformable segments 22. Specifically, a first anchoring segment 21A is shown located between section EE and section CC, and a second anchoring segment 21B is shown located between section DD and section FF. The first anchoring segment 21A has a length L21A along the longitudinal axis CL. The second anchoring segment 21B has a length L21B along the longitudinal axis CL.
[0096] Figure 8B An exemplary second set of cross-sections of a second section according to one or more embodiments of the present disclosure is shown. Relative to Figure 6B It also describes the region of the second set of cross sections in the second segment.
[0097] Figure 9A A first segment 1 having a circular cross-section is shown according to one or more embodiments of the present disclosure.
[0098] Figure 9B A first segment 1 having a triangular cross-section is shown according to one or more embodiments of the present disclosure.
[0099] Figure 9C A first segment 1 having a star-shaped cross-section is shown according to one or more embodiments of the present disclosure.
[0100] Sometimes, ultrasound imaging equipment is used to perform initial positioning of reference positioning marker 5 in patient tissue. Depending on the equipment used and the location of reference positioning marker 5 in the tissue, the visibility of reference positioning marker 5 in the ultrasound image is reduced. This disclosure improves the visibility of reference positioning marker 5 in ultrasound images by providing reflective elements, such as recesses provided with concave surfaces for reflecting and focusing ultrasound waves or ultrasound signals generated by the ultrasound imaging equipment.
[0101] Figure 10A A first section of reference positioning mark 5, in accordance with one or more embodiments of the present disclosure, is shown, in which a reflector element 1010 is disposed. A vertical dotted line marks the section between the first section 1 and the second section 2.
[0102] As in Figure 10A As can be seen, the first section 1 is provided with a plurality of reflector elements 1010, which are shown as recesses. These recesses are provided with concave surfaces for reflecting and focusing ultrasonic waves or ultrasonic signals generated by the ultrasonic imaging device.
[0103] Without departing from this concept, any other recess or indentation configured to reflect and focus ultrasonic and / or radiated waves may be used.
[0104] Figure 10B A detailed view of a reference positioning mark 5 provided with a plurality of reflector elements 1010 according to one or more embodiments of the present disclosure is shown.
[0105] In some embodiments, a plurality of reflector elements 1010 may be distributed substantially evenly over the surface of the first segment of the reference positioning mark 5.
[0106] In some embodiments, the plurality of reflector elements 1010 may include recesses, particularly recesses created by embossing the outer surface of a first segment of the reference positioning mark 5, thereby creating a recess in the outer surface of the first segment of the reference positioning mark 5. The reflector elements 1010 improve visibility when imaging the reference positioning mark 5.
[0107] Finally, it should be understood that the present invention is not limited to the embodiments described above, but also relates to and incorporates all embodiments within the scope of the appended independent claims.
Claims
1. A reference positioning marker (5) suitable for radiotherapy, microwave therapy, cryosurgery, or ultrasound therapy that is implanted in tissue using a hollow injection needle (4). in, The marking includes an elongated object having a longitudinal axis (CL) and a cross section (AA, BB, CC, DD, EE, FF) perpendicular to the longitudinal axis (CL) and adapted to be fitted into the inner diameter (DI) of the injection needle (4). The marker (5) includes a plurality of first segments (1) having a first cross-section and one or more second segments (2) having a second set of cross-sections, wherein the region of the first cross-section is selected to be relatively larger than the region of the second set of cross-sections, and wherein the first segments (1) and the second segments (2) are arranged alternately along the longitudinal axis (CL). Each of the one or more second segments (2) is provided with a deformable segment (22) adapted to ensure that any deformation of the plurality of second segments when positioned inside the injection needle occurs at a predetermined position between adjacent first segments, such that when the mark (5) encounters resistance during implantation into the tissue, the plurality of first segments remain linearly aligned in the injection needle. The deformable section (22) is formed as a curved portion, which extends from the outer surface of the corresponding end (E1, E2) of the second section in a direction toward the longitudinal axis (CL). In a side view of one or more deformed sections, the outer surface of the curved portion defines a recess on a first side extending along the longitudinal axis and a convex portion on a second side opposite to the first side. The radial distance of each of the recess and the convex portion to the longitudinal axis varies, and each of the recess and the convex portion has a single vertex in the side view. Furthermore, the respective vertices of the recess and the convex portion coincide and lie in the same YZ plane perpendicular to the longitudinal axis. The second segment further includes a first anchoring segment and a second anchoring segment disposed on the opposite side of the one or more deformable segments, wherein the first anchoring segment is disposed between a first adjacent segment and one or more deformable segments of an adjacent second segment, and the second anchoring segment is disposed between another first adjacent segment and one or more deformable segments of an adjacent second segment. Wherein, the first cross-section is solid, and The second set of cross-sections includes: The cross-sections of the first anchorage section and the second anchorage section each have their own first anchorage section area and second anchorage section area. The second end cross section having its own second end region, and One or more deformation segment cross sections, each with its own deformation zone region. The first anchorage section region and the second anchorage section region range from the second end region, which is equal to the cross-section of the second end, to the deformation section region, which is equal to the cross-section of one or more deformation sections.
2. The mark according to claim 1, wherein, The deformable segment (22) is centered between the corresponding adjacent first segments (AJ1, AJ2), and the deformable segment (22) includes the smallest region (AR2) of the regions (AR2, AR3, AR4) of the second set of cross sections (BB, CC, DD).
3. The mark according to claim 2, wherein, The minimum region (AR2) is also centered on the longitudinal axis (CL).
4. The mark according to claim 1, wherein, The curved portion has a bending radius (R) that is equal to or greater than half the diameter of the circle (CK) that encloses the contour of the first cross section.
5. The mark (5) according to any one of the preceding claims, wherein, The marking includes a density of at least 10 g / cm³. 3 The first material constitutes at least 90% of the volume of the mark, wherein the mark includes a second material that is magnetic and constitutes at most 10% of the volume of the mark, and wherein the mark includes an alloy or particulate mixture having the first material and the second material.
6. The mark (5) according to any one of the preceding claims, wherein, The marker (5) includes two to fifteen first segments (1) and one to fourteen second segments (2).
7. The mark (5) according to any one of the preceding claims, wherein, The marker (5) includes a plurality of reflector elements (1010).