Marker

Abstract

The utility model relates to the technical field of medical instruments. A marker comprises a gold mark assembly, and the gold mark assembly comprises a gold calibration structure and an anchoring part used for anchoring the gold calibration structure; the anchoring part is made of shape memory alloy and comprises a fixing part used for fixing the gold calibration structure and a deformation part used for anchoring. The fixed part is fixedly connected with the deformation part, and the deformation part is of a bending angle variable structure. According to the utility model, a bending angle variable structure is arranged on the optimized gold mark assembly, so that an anchoring extension claw is conveniently formed for anchoring after the marker is released.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a marker. Background Art

[0002] Traditional stereotactic radiotherapy techniques, such as the Gamma Knife, typically rely on surface markers or external fixators to help locate the radiotherapy field. This positioning method is subject to certain errors, especially when the patient moves slightly, which can cause deviation from the radiation field. This not only reduces treatment effectiveness but also may cause unnecessary injury. A new stereotactic radiotherapy device, the CyberKnife, has recently emerged. It is a synchronized radiotherapy device that can achieve real-time three-dimensional tracking of tumor position. It is currently the world's most advanced whole-body three-dimensional radiosurgery device. This method achieves real-time target tracking through the device's built-in CT (Computed Tomography) positioning system, which tracks the tumor position once per second. Based on this tracked position information, the position and angle of the radiotherapy head are precisely adjusted, enabling stereotactic radiotherapy with an accuracy of within 1mm. To better track tumor position, certain tumors with unique properties or locations (such as liver and prostate tumors) often require percutaneous implantation of CT-sensitive markers, such as metal tracking markers (gold labels), to help the device accurately track the tumor position.

[0003] Currently commonly used markers have poor "anchoring" performance in the human body and are prone to deviation, affecting the treatment effect.

[0004] Existing gold labels are typically cylindrical in shape, which has limitations during implantation. Cylindrical gold labels are prone to displacement or loss due to breathing and coughing, leading to significant positional deviations during treatment. This can directly impact the accuracy of tumor treatment and compromise treatment outcomes. Utility Model Content

[0005] In response to the problems existing in the prior art, the present invention provides a marker that solves at least one of the above technical problems.

[0006] The technical solution of the utility model is: a marker, characterized in that it includes a gold label component, the gold label component includes a gold calibration structure and an anchor for anchoring the gold calibration structure;

[0007] The anchoring piece is made of shape memory alloy and comprises a fixing portion for fixing the gold calibration structure and a deformable portion for anchoring;

[0008] The fixing portion is fixedly connected to the deformable portion, and the deformable portion is a structure with a variable bending angle.

[0009] The utility model optimizes the gold label component and is provided with a variable bending angle structure, so that after the marker is released, anchoring extension claws are formed for anchoring.

[0010] Further preferably, the shape memory alloy is nickel-titanium shape memory alloy.

[0011] As a preferred solution, both ends of the fixing portion in the axial direction are connected to the deformation portion.

[0012] The deformation process of the deformation portion is that the U-shaped bending structure is deformed from a folded state to an L-shaped bending structure.

[0013] The U-shaped bending structure makes it easy to store, and the L-shaped bending structure makes it easy to anchor at the target location.

[0014] Further preferably, at least one anchor is provided.

[0015] As another preferred solution, two anchors are provided;

[0016] The deformable portion is connected to both axial ends of the fixing portion;

[0017] The fixing parts of the two anchoring pieces are arranged closely and side by side, and the two anchoring pieces are arranged in a centrally symmetrical manner.

[0018] Further preferably, the deformation portions of the two anchors each include a first extension portion, a bending portion, and a second extension portion connected in sequence;

[0019] The first extension portions of the two anchors are both connected to the end portion of the fixing portion, and the first extension portions of the two anchors are closely arranged along the first straight line direction;

[0020] The second extensions of the two anchors are respectively located on different sides in the second straight line direction;

[0021] The first straight line direction is perpendicular to the second straight line direction, and both the first straight line direction and the second straight line direction are perpendicular to the axial direction of the fixing portion.

[0022] As another preferred solution, two fixing parts are provided, and the two fixing parts are connected via the deformation part;

[0023] The deformation portion is a bending structure connecting the two fixing portions.

[0024] It is convenient to achieve the anchoring effect by changing the angle of the bending structure.

[0025] More preferably, it further comprises a filling component for filling the gold label component;

[0026] The loading assembly includes an introduction slot for introducing the gold label assembly and a storage slot for storing the gold label assembly, wherein the introduction slot is connected to the storage slot, and the inner diameter of the introduction slot increases from the side adjacent to the storage slot to the side away from the storage slot;

[0027] The gold label component is located in the storage tank.

[0028] It is convenient for storing the gold label component and switching the gold label component together with the filling component. The gold label component is pushed through the needle core to implant the marker.

[0029] Further preferably, the gold label assembly is fixed to the end of the storage tank away from the introduction tank by paraffin.

[0030] This facilitates securing the gold label component within the loading mechanism. Harmless paraffin wax is used to fuse with the gold label component to secure the marker, preventing it from falling out. The paraffin wax prevents the gold label component from getting stuck during delivery and acts as a lubricant. It also seals the delivery channel, reducing air ingress and preventing pneumothorax.

[0031] Further preferably, when the gold label component is located in the storage slot, the deformation portion is in a retracted state;

[0032] When the gold label component is pushed into the storage slot, the deformation portion is in an outwardly extended state.

[0033] Alternatively, when the gold label assembly is located in the storage slot, at least two of the fixing portions are arranged along the storage slot;

[0034] When the gold label component is pushed out of the storage slot, the deformable portion assumes an initial shape, and the angle between two adjacent fixing portions switches to 45°-80°.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] 1. In lung applications, traditional markers are prone to displacement due to the loose texture of the organ. The markers in this solution have a unique "anchoring" structure and excellent "anchoring" performance. After implantation into the human body, they are not easily moved with human movement and breathing, resulting in deviation from the radiotherapy target area, thereby improving the accuracy and treatment effect of stereotactic radiotherapy for body tumors.

[0037] 2. Convenient marker loading and implantation. A loading assembly is provided, and the marker is pre-loaded in the loading assembly, making it easy to replace and store the marker. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a schematic structural diagram of a specific embodiment 1 of the present invention when a marker is stored in a filling assembly;

[0039] Figure 2 This is a schematic diagram of the structure of the specific embodiment 1 of the present invention after the marker is pushed out of the filling assembly;

[0040] Figure 3 This is a schematic structural diagram of a specific embodiment 2 of the present invention when a marker is stored in a filling assembly;

[0041] Figure 4 This is a schematic diagram of the structure of the specific embodiment 2 of the present invention after the marker is pushed out of the filling assembly;

[0042] Figure 5 This is a schematic diagram of the structure of the specific embodiment 2 of the present invention after the marker is pushed out of the filling assembly;

[0043] Figure 6 This is a cross-sectional view of the combination of the marker and the filling component in specific embodiment 3 of the present invention;

[0044] Figure 7 This is a schematic diagram of the structure of the specific embodiment 3 of the present invention after the marker is pushed out of the filling assembly;

[0045] Figure 8 This is a cross-sectional view of a specific embodiment 4 of the present utility model;

[0046] Figure 9 This is a structural diagram of a specific embodiment 4 of the present utility model;

[0047] Figure 10 This is an exploded view of specific embodiment 4 of the present utility model;

[0048] Figure 11 This is an exploded view of specific embodiment 4 of the present utility model;

[0049] Figure 12 This is a schematic structural diagram of the filling assembly of specific embodiment 4 of the present utility model. DETAILED DESCRIPTION

[0050] See also Figures 1 to 2 Specific embodiment 1, a marker includes a gold label assembly, the gold label assembly including a gold calibration structure 4.11 and an anchor 4.12 for anchoring the gold calibration structure. Anchor 4.12 is made of a shape memory alloy and includes a fixed portion for securing the gold calibration structure and a deformable portion for anchoring. The fixed portion is fixedly connected to the deformable portion, and the deformable portion is a variable-bending structure. The present invention optimizes the gold label assembly and provides a variable-bending structure, facilitating the formation of an extended anchoring claw for anchoring after the marker is released.

[0051] The gold calibration structure can be set in a spiral.

[0052] The outer side of the fixing portion may be connected to the deformable portion, or the inner side of the fixing portion may be connected to the deformable portion.

[0053] The shape memory alloy is nickel-titanium shape memory alloy. The fixing portion is cylindrical.

[0054] The fixing portion is connected to a deformable portion at both axial ends. The deformable portion can be deformed from a U-shaped structure to an L-shaped structure. The U-shaped structure facilitates storage, while the L-shaped structure facilitates anchoring at the target location.

[0055] At least one anchor 4.12 is provided.

[0056] See also Figure 3 、 Figure 4 as well as Figure 5 Specific embodiment 2, based on specific embodiment 1, two anchors 4.12 are provided in the gold mark component 4; the axial ends of the fixing portion are connected with a deformation portion; the fixing portions of the two anchors 4.12 are arranged tightly side by side, and the two anchors 4.12 are arranged in a central symmetrical manner.

[0057] The deformation parts of the two anchors 4.12 include a first extension part 121, a bending part 122 and a second extension part 123 connected in sequence; the first extension parts 121 of the two anchors 4.12 are connected to the end of the fixed part, and the first extension parts 121 of the two anchors 4.12 are tightly arranged along the first straight line direction; the second extension parts 123 of the two anchors 4.12 are respectively located on different sides of the second straight line direction; the first straight line direction is perpendicular to the second straight line direction, and the first straight line direction and the second straight line direction are both perpendicular to the axial direction of the fixed part.

[0058] See also Figure 6 as well as Figure 7 Specific embodiment 3, a marker, characterized by including a gold label assembly, the gold label assembly including a spirally arranged gold calibration structure 4.11 and an anchor 4.12 for anchoring the gold calibration structure; the anchor 4.12 is made of a shape memory alloy and includes a fixed portion for securing the gold calibration structure and a deformable portion for anchoring; the fixed portion is fixedly connected to the deformable portion, and the deformable portion is a variable bending angle structure. By optimizing the variable bending angle structure provided on the gold label assembly, the present invention facilitates the formation of an anchoring extension claw for anchoring after the marker is released.

[0059] The shape memory alloy is nickel-titanium shape memory alloy.

[0060] There are two fixing parts, which are connected by an anchor 4.12; the deformation part is a bending structure connecting the two fixing parts. It is convenient to achieve the anchoring effect by changing the angle of the bending structure. Figure 6 The state of the gold label component 4 pushing out the filling component 1, see Figure 7 .

[0061] See also Figures 8 to 12 Specific embodiment 4, based on specific embodiments 1 to 3, further includes a loading assembly 1 for loading a gold label assembly 4. The loading assembly 1 includes an introduction slot for introducing the gold label assembly 4 and a storage slot for storing the gold label assembly 4. The introduction slot and the storage slot are connected and connected, and the inner diameter of the introduction slot increases from the side adjacent to the storage slot to the side distal to the storage slot. The gold label assembly 4 is located in the storage slot. This facilitates the storage of the gold label assembly 4 and facilitates its replacement together with the loading assembly. The gold label assembly 4 is pushed by the needle core to implant the marker. When the gold label assembly 4 is in the storage slot, the deformable portion assumes a U-shaped storage configuration. When the gold label assembly 4 is released from the storage slot, the deformable portion assumes an initial L-shaped, outward-bent configuration. Alternatively, when the gold label assembly 4 is in the storage slot, at least two fixing portions are arranged along the storage slot. When the gold label assembly 4 is released from the storage slot, the deformable portion assumes its initial configuration, and the angle between two adjacent fixing portions changes to 45°-80°.

[0062] The marker is used in conjunction with an implantation device, which includes a puncture needle outer tube 2 and a needle core 3; the puncture needle outer tube 2 includes an outer needle tube 2.2 and an outer needle seat 2.1 connected in sequence, the outer needle seat 2.1 is provided with a guide positioning groove for axially inserting the filling component 1, and the guide positioning groove is connected to the inner cavity of the outer needle tube 2.2; the inner cavity of the filling component 1 is provided with a through hole, the through hole includes a storage groove 1.3 for storing the gold label component 4 and an introduction groove 1.2 for pushing the gold label component 4 into the storage cavity, the introduction groove 1.2 is connected to the storage groove 1.3, the storage groove 1.3 is connected to the inner cavity of the outer needle tube 2.2, and the through hole is connected to the outer needle tube 2.2 to form a channel for guiding the insertion of the needle core 3. The utility model simplifies the loading process of the gold label component 4 through the provision of the loading component 1, and facilitates the rapid loading of the gold label component 4 and the pushing of the needle core 3 to the target position. The utility model realizes multiple implantations of the gold label component 4 with one puncture, thereby greatly reducing the number of punctures on the patient.

[0063] The end of the storage tank 1.3 away from the introduction tank 1.2 is connected to the gold label component 4 through paraffin. It is convenient to fix the gold label component 4 in the filling component 1. Paraffin wax, which is harmless to the human body, is used to fuse and fix the gold label component 4 to prevent the pre-installed gold label component 4 from falling off. It is convenient to fix the gold label component in the filling mechanism. Paraffin wax, which is harmless to the human body, is used to fuse and fix the marker with the gold label component to prevent the pre-installed gold label component from falling off. Paraffin wax can prevent the gold label component from getting stuck during the pushing process and has a lubricating effect. At the same time, it can also achieve blocking of the delivery channel, which has the effect of reducing gas entry and preventing pneumothorax.

[0064] The outer needle tube 2.2 and outer needle hub 2.1 are arranged in a front-to-rear arrangement. The guide and positioning groove is a tapered groove with an increasing inner diameter from front to back. The filling assembly 1 includes a tapered insert portion that matches the tapered groove. The rear end of the tapered insert portion is provided with an extension portion 1.1 extending radially outward. The front and rear sides of the extension portion 1.1 respectively abut against the outer needle hub 2.1 and the needle core 3. The extension portion 1.1 facilitates the removal and installation of the filling assembly 1 and facilitates the relative positioning of the filling assembly 1, outer needle hub 2.1, and needle core 3.

[0065] The needle core 3 includes an inner needle body and an inner needle seat arranged in front and back; when the front end of the inner needle seat abuts against the extension part 1.1, and the rear end of the outer needle seat 2.1 abuts against the extension part 1.1, the front end of the inner needle body is flush with the needle tip of the outer needle tube 2.2.

[0066] When the gold label component 4 is implanted for the first time, a gold label component 4 is pre-installed inside the front end of the outer needle tube 2.2 of the puncture needle outer tube 2, and a filling component 1 without the gold label component 4 is pre-installed on the outer needle base 2.1 of the puncture needle outer tube 2. The puncture needle outer tube 2 is inserted into the target area near or inside the human tumor. Then, the needle core 3 is inserted from the introduction groove 1.2 of the filling component 1 and pushed forward until the gold label component 4 at the front end of the outer needle core 3 of the puncture needle outer tube 2 is pushed out and reaches the designated area of the tumor. At this point, the first implantation of the gold label component 4 is completed.

[0067] When multiple gold label components 4 need to be implanted, first, the original needle core 3 needs to be withdrawn from the filling component 1, and then the filling component 1 is removed by holding the filling component 1 with one hand; then, the filling component 1 pre-installed with the gold label component 4 is installed into the outer needle seat 2.1 of the outer tube; then, the needle core 3 is inserted from the introduction groove 1.2 of the filling component 1, and the needle core 3 is pushed until the gold label component 4 slides into the outer needle tube 2.2 of the puncture needle outer tube 2, and continues to be pushed until the front end of the needle core 3 is level with the needle tip of the puncture needle outer tube 2, and the gold label component 4 is pushed out of the puncture needle outer tube 2 to reach the designated area of the tumor, thereby completing the implantation of the second gold label component 4.

[0068] For subsequent implantation of the gold label component 4, the need for repeated punctures is avoided. The operator simply withdraws the needle core 3, removes the filling component 1 without the gold label component 4, and installs the filling component 1 with the gold label component 4 into the outer needle hub 2.1 of the puncture needle outer tube 2. The gold label component 4 is then accurately implanted again after the procedure is repeated. This process can be repeated, enabling multiple implantations with a single puncture, improving treatment efficiency and accuracy while reducing the risk of additional harm to the patient and the risk of pneumothorax.

[0069] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A marker, characterized in that It comprises a gold mark component, wherein the gold mark component comprises a gold mark structure and an anchor for anchoring the gold mark structure; The anchoring piece is made of shape memory alloy and comprises a fixing portion for fixing the gold calibration structure and a deformable portion for anchoring; The fixing portion is connected to the deformable portion, and the deformable portion is a structure with a variable bending angle.

2. A marker according to claim 1, characterized in that: The shape memory alloy is nickel-titanium shape memory alloy.

3. A marker according to claim 1, characterized in that: The deformable portion is connected to both ends of the fixing portion in the axial direction.

4. A marker according to claim 3, characterized in that: At least one anchor is provided.

5. A marker according to claim 1, characterized in that: There are two anchors; The deformable portion is connected to both axial ends of the fixing portion; The fixing parts of the two anchoring pieces are arranged closely and side by side, and the two anchoring pieces are arranged in a centrally symmetrical manner.

6. A marker according to claim 5, characterized in that: The deformation portions of the two anchors each include a first extension portion, a bending portion, and a second extension portion connected in sequence; The first extension portions of the two anchors are both connected to the end portion of the fixing portion, and the first extension portions of the two anchors are closely arranged along the first straight line direction; The second extensions of the two anchors are respectively located on different sides in the second straight line direction; The first straight line direction is perpendicular to the second straight line direction, and both the first straight line direction and the second straight line direction are perpendicular to the axial direction of the fixing portion.

7. A marker according to claim 1, characterized in that: There are two fixing parts, and the two fixing parts are connected via the deformation part; The deformation portion is a bending structure connecting the two fixing portions.

8. A marker according to claim 1, characterized in that: Also included is a filling component for filling the gold label component; The loading assembly includes an introduction slot for introducing the gold label assembly and a storage slot for storing the gold label assembly, wherein the introduction slot is connected to the storage slot, and the inner diameter of the introduction slot increases from the side adjacent to the storage slot to the side away from the storage slot; The gold label component is located in the storage tank.

9. A marker according to claim 8, characterized in that: When the gold label component is located in the storage slot, the deformable portion is in a retracted state; When the gold label component is pushed into the storage slot, the deformation portion is in an outwardly extended state.

10. A marker according to claim 8, characterized in that: The gold label component is fixed to the end of the storage tank away from the introduction tank by paraffin.

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