Internal radiotherapy system for treating spinal metastatic tumor

Abstract

The invention relates to an internal radiotherapy system for treating spinal metastatic tumor, which comprises a bag body, radioactive particles and bone cement filler, and is characterized in that the bag body comprises a peripheral wall made of a flexible material, an inner cavity is defined by the peripheral wall, and a plurality of meshes are formed in the peripheral wall; the radioactive particles are fixed on the outer side surface of the bag body; the inner cavity of the bag body is filled with the bone cement filler so that the bag body can be opened, and the meshes allow part of the bone cement filler to seep to the outer side of the bag body from the meshes to form an anchoring part.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an internal radiotherapy system for treating spinal metastases. Background Art

[0002] Spinal metastases are the most common type of spinal tumor, with an increasing incidence in recent years. Nearly 70% of patients with malignant tumors will develop spinal metastases. These metastases often result in severe local pain, pathological fractures, and spinal nerve compression, leading to decreased motor and sensory function in the patient's limbs, and even irreversible spinal cord injury, ultimately leading to paraplegia. These metastases are a significant factor in reducing patients' quality of life and even death in the later stages of the disease.

[0003] Currently, the main treatments for spinal metastases include radiotherapy, chemotherapy, and surgery. Surgical treatment can relieve local pain, restore spinal stability, improve neurological function, control local recurrence, and improve the patient's quality of life. Since the survival of patients with spinal metastases is generally 6-16 months, the focus and purpose of clinical treatment is often to improve the patient's quality of life and alleviate their pain. Currently, open surgical procedures mainly include total spondylectomy and metastasis separation, which have disadvantages such as greater trauma, excessive bleeding, narrow indications, and a high recurrence rate. Their clinical application has gradually decreased in recent years.

[0004] Radiation therapy for spinal metastases can be used alone or in combination with surgery or chemotherapy. It can relieve pain, delay or reverse neuromotor dysfunction, improve local tumor control, and improve quality of life. However, due to the presence of specialized neural tissue in the spine (the spinal cord and cauda equina), many normal tissues, including the spinal cord, are also exposed to radiation during radiotherapy. The therapeutic dose is often limited by the tolerance of the spinal cord and cauda equina, making satisfactory results difficult to achieve. Consequently, the application of traditional external beam radiotherapy for spinal metastases is significantly limited.

[0005] Radiation seed implantation is a brachytherapy method. 125I seeds implanted in the tumor continuously release gamma rays, killing tumor cells and alleviating the pain caused by the tumor tissue. Compared with external radiotherapy, 125I seed implantation has the following advantages: ① The intralesional radiotherapy dose is higher, with the cumulative radiation dose reaching 2-3 times that of external radiotherapy, effectively killing tumor cells; ② The radiation intensity decreases rapidly with distance, allowing targeted radiotherapy of nearly any tumor shape with minimal damage to surrounding normal tissue; ③ It can be used for patients with recurrence after external radiotherapy and is not affected by the cumulative effect on the spinal cord; ④ The procedure is completed in a single procedure, unlike external radiotherapy, which requires multiple sessions, reducing patient discomfort and inconvenience.

[0006] In patent application number CN202410996222.7, the inventors disclosed a spinal metastasis radiotherapy stent system. The system utilizes a memory alloy stent with radioactive particles mounted on it. The stent's expansion allows the particles to approach or contact tumor cells at close range, resulting in a sustained killing effect on the cells, alleviating symptoms and prolonging patient survival. However, in clinical trials, the rigidity of the memory alloy stent made it difficult to implant the stent into the irregular prefabricated spaces within vertebral tumors. Furthermore, some radioactive particles were unable to approach or contact tumor cells, resulting in blind spots for radiation. Furthermore, if the memory alloy stent were directly replaced with a flexible stent, securing the flexible stent within the prefabricated spaces within the vertebral tumors would be difficult. Therefore, the present invention provides an internal radiotherapy system for treating spinal metastases that not only adapts to the irregular prefabricated spaces within vertebral tumors but also allows for easy fixation within the prefabricated spaces within the vertebral tumors. Summary of the Invention

[0007] The purpose of the present invention is to provide an internal radiotherapy system for treating spinal metastases that can not only adapt to the irregular prefabricated space within the vertebral tumor, but also be conveniently fixed within the prefabricated space within the vertebral tumor.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] An internal radiotherapy system for treating spinal metastases, comprising:

[0010] A bag body, the bag body comprising a peripheral wall made of a flexible material, the peripheral wall enclosing an inner cavity, and the peripheral wall being provided with a plurality of meshes;

[0011] radioactive particles, the radioactive particles being fixed to the outer side of the bag;

[0012] Bone cement filler is filled in the inner cavity of the bag body to expand the bag body, and the mesh allows part of the bone cement filler to seep out of the mesh to the outside of the bag body to form an anchoring portion.

[0013] In one embodiment, the mesh area of ​​the mesh is 0.6-1.6 mm 2 .

[0014] In one embodiment, the mesh area of ​​the mesh is 0.9-1.1 mm 2 .

[0015] In one embodiment, the plurality of meshes are substantially evenly distributed on the bag body.

[0016] In one embodiment, the plurality of meshes are unevenly distributed on the bag, wherein the mesh density of the area around the bag where the radioactive particles are fixed is smaller than the mesh density of the area of ​​the bag where no radioactive particles are set.

[0017] In one embodiment, a plurality of bags are fixed to the outer side of the bag body, and the radioactive particles are located in the bags.

[0018] In one embodiment, the bag body is made of PET mesh.

[0019] In one embodiment, the bag body is in the shape of an elongated strip, the front end of the bag body is provided with a constriction opening, and the rear end of the bag body is provided with an open opening.

[0020] In one embodiment, the radioactive particles are iodine-125 particles.

[0021] In one embodiment, the internal radiotherapy system further includes a sleeve, and the bag can be accommodated in the sleeve.

[0022] The present invention employs the above-mentioned technical solution, resulting in the beneficial effect that the internal radiotherapy system for treating spinal metastases provided by the present invention combines radioactive particles with bone cement to treat spinal metastases, effectively resolving the key issues of uneven spatial distribution of radioactive particles within the tumor and particle migration. Furthermore, compared to memory alloy stents, the bag of the present invention is flexible and can adapt to irregular tumor cavities, allowing the radioactive ions on the outer surface of the bag to be closer to the tumor tissue, resulting in a better therapeutic effect. Simultaneously, the mesh of the bag allows some bone cement to seep out, forming a burr-like anchoring portion, thereby increasing the local anchoring force and achieving the purpose of securing the bag. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A schematic diagram of an internal radiotherapy system is shown.

[0024] Figure 2 A schematic diagram of the bag is shown.

[0025] Figure 3 A schematic diagram showing radioactive particles fixed on a bag is shown.

[0026] Figure 4 A rear schematic diagram showing the endoradiation system placed within the cannula.

[0027] Figure 5 A schematic diagram shows an internal radiotherapy system placed in a cannula and entering the vertebral body through a puncture channel.

[0028] Figure 6 Schematic diagram showing the internal radiotherapy system being advanced into the vertebral body.

[0029] Figure 7A schematic diagram showing the injection of bone cement into the bag through the puncture channel.

[0030] Figure 8 It shows a schematic diagram of the bag body after the bone cement fills the internal space of the bag body and part of the bone cement seeps out of the bag body to form an anchoring part. DETAILED DESCRIPTION

[0031] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings so that the objects, features and advantages of the present invention can be more clearly understood. It should be understood that the embodiments shown in the accompanying drawings are not intended to limit the scope of the present invention, but are only intended to illustrate the essential spirit of the technical solution of the present invention.

[0032] In the following description, for the purpose of illustrating the various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other cases, well-known devices, structures, and techniques associated with this application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0033] Unless the context requires otherwise, throughout the specification and claims, the word "comprise" and variations such as "include" and "have" should be construed in an open, inclusive sense, that is, should be interpreted to mean "including, but not limited to."

[0034] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0035] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0036] In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but words such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and should not be understood as restrictive terms.

[0037] Furthermore, terms such as "horizontal," "vertical," and "overhanging" do not necessarily imply that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0038] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0039] The present invention provides an internal radiotherapy system for treating spinal metastases. Figure 1-Figure 3 The internal radiotherapy system includes a flexible bag 1, radioactive particles 2 fixed outside the bag, and bone cement filler 3. Figure 2 The bag body 1 in this embodiment is made of polyethylene terephthalate (PET) mesh cloth that is cut and sewn to form a long strip of bag body. The front end of the bag body 1 is provided with a bundle opening, and the rear end of the bag body 1 is provided with an open opening to facilitate the filling of the bone cement filler 3 into the bag body 1. Bags 11 for wrapping the radioactive particles 2 are preset along the longitudinal axis on the outer surface of the bag body 1. The number of bags 11 can match the number of radioactive particles 2 to be placed, or can be more than the number of radioactive particles to be placed. For example, two groups of bags are provided on the outer peripheral surface of the bag body 1 in this embodiment, and each group of bags has a bag 11 provided at a preset distance in the axial direction of the bag body. The preset distance can be determined according to actual needs.

[0040] The radioactive particles 2 are assembled into the corresponding capsule 11 and fixed according to the location of the patient's lesion. In this embodiment, the radioactive particles 2 are iodine 125 ( 125 I) particles, the outer diameter of conventional specifications is 0.6mm or 0.8mm, and the length is 4.5mm, so the bag 11 matches the size of the iodine 125 particles, but is not limited to this. The size of the bag 11 can also be adapted according to the actual size of the radioactive particles.

[0041] The bag body 1 is also provided with a mesh, the size of which allows the bone cement filler 3 filled into the bag body 1 to, after reaching a preset pressure, a small portion of the bone cement filler 3 can be seeped out of the mesh to the outside of the bag body 1 to form a burr-shaped anchoring portion, thereby increasing the local anchoring force to achieve the purpose of fixing the bag body. The mesh can be roughly evenly distributed on the entire bag body, so that it is only necessary to select the corresponding mesh cloth according to the mesh size for sewing, and the preparation method is simple and the cost is low. The mesh can also be unevenly distributed on the bag body, such as not setting a mesh or setting a relatively small amount of mesh in the surrounding area where the radioactive particles 2 are placed, so that the bone cement filler 3 will not seep out from the surrounding area of ​​the radioactive particles 2 or the amount of seepage relative to other areas is smaller, thereby allowing the radioactive particles 2 to be closer to the lesion position and achieve a better therapeutic effect. For a bag body with uneven mesh distribution, a plurality of mesh cloths with different mesh densities can be spliced ​​together to form it. In addition, since there is no mesh or a relatively small amount of mesh around the radioactive particle 2, there is no or only a small amount of burr-shaped anchoring portion around the radioactive particle 2, which can reduce the obstruction of the tumor tissue at the lesion location by bone cement and enhance the effect of the radioactive particle on reducing the tumor.

[0042] The mesh is usually formed by the gaps formed by the horizontal and vertical interlacing during the weaving process of the mesh, which is roughly rectangular in shape when stretched. Of course, different mesh shapes can also be formed by different weaving processes, such as circles, regular polygons or other irregular shapes. Preferably, the mesh size is 0.6-1.6mm 2 , more preferably 0.9-1.1mm 2 . The mesh size is 1mm 2 This can ensure that the bone cement filler 3 can fully expand the bag body 1, allowing the radioactive particles 2 fixed on the outside of the bag body to be close to the lesion location, and allow a small amount of bone cement filler 3 to seep out to the outside of the bag body 1 to form a burr-shaped anchoring part, thereby increasing the local anchoring force to achieve the purpose of fixing the bag body.

[0043] See also Figure 4-Figure 8 , Figure 4-Figure 8 A schematic diagram of the intraoperative use of the internal radiotherapy system is shown.

[0044] 1. The patient first undergoes pedicle puncture to the diseased vertebral body to establish a puncture channel, and uses radiofrequency ablation to remove part of the tumor tissue, or uses an expansion balloon to pre-expand the tumor body to pre-create an implant space for the internal radiotherapy system.

[0045] 2. See Figure 5 and Figure 6 The compressed bag 1 loaded with radioactive particles 2 is pushed into the prefabricated implantation space in the vertebral tumor along the established puncture channel (see Figure 4 , the bag body 1 has been placed in the sleeve 4 before or during the operation).

[0046] 3. See Figure 7 and Figure 8 After the bag 1 is implanted, the bone cement filler 3 is injected through the internal bone cement injection guide rod to expand the bag, allowing the radioactive particles 2 on the outside of the bag 1 to be close to the lesion. At the same time, after hardening, the bone cement can also play a role in reinforcing the vertebral body and preventing vertebral fracture and collapse. As the bone cement filling reaches a certain pressure, a small amount of bone cement is allowed to seep out of the mesh to form a burr-like anchoring part, thereby increasing the local anchoring force and achieving the purpose of fixing the bag. The radioactive particles carried on the outer surface of the mesh bag can continuously kill the remaining tumor cells in the surrounding area and prevent recurrence.

[0047] The internal radiotherapy system provided in this embodiment combines radioactive particles with bone cement to treat spinal metastases, effectively addressing the key issues of uneven spatial distribution of radioactive particles within the tumor and particle migration. Compared to memory alloy stents, the flexible bag of this application can adapt to irregular tumor cavities, allowing the radioactive ions on the outer surface of the bag to be closer to the tumor tissue, achieving a better therapeutic effect. Simultaneously, the mesh of the bag allows some bone cement to seep out, forming a burr-like anchoring portion, thereby increasing local anchoring force and achieving the purpose of securing the bag.

[0048] While the preferred embodiments of the present invention have been described in detail above, it should be understood that, after reading the above teachings of the present invention, those skilled in the art may make various changes or modifications to the present invention. Such equivalents also fall within the scope defined by the appended claims.

Claims

1. An internal radiotherapy system for treating spinal metastases, characterized in that: include: A bag body, the bag body comprising a peripheral wall made of a flexible material, the peripheral wall enclosing an inner cavity, and the peripheral wall being provided with a plurality of meshes; radioactive particles, the radioactive particles being fixed to the outer side of the bag; Bone cement filler is filled in the inner cavity of the bag body to expand the bag body, and the mesh allows part of the bone cement filler to seep out of the mesh to the outside of the bag body to form an anchoring portion.

2. The internal radiotherapy system according to claim 1, wherein: The mesh area of ​​the mesh is 0.6-1.6mm 2 .

3. The internal radiotherapy system according to claim 2, wherein: The mesh area of ​​the mesh is 0.9-1.1mm 2 .

4. The internal radiotherapy system according to claim 1, wherein: The plurality of meshes are roughly evenly distributed on the bag body.

5. The internal radiotherapy system according to claim 1, wherein: The plurality of meshes are unevenly distributed on the bag body, wherein the mesh density of the area around the bag body where the radioactive particles are fixed is smaller than the mesh density of the area of ​​the bag body where no radioactive particles are set.

6. The internal radiotherapy system according to claim 1, wherein: A plurality of bags are fixed on the outer side of the bag body, and the radioactive particles are located in the bags.

7. The internal radiotherapy system according to claim 1, wherein: The bag body is made of PET mesh.

8. The internal radiotherapy system according to claim 1, wherein: The bag body is in the shape of an elongated strip, the front end of the bag body is provided with a constriction opening, and the rear end of the bag body is provided with an open opening.

9. The internal radiotherapy system according to claim 1, wherein: The radioactive particles are iodine-125 particles.

10. The internal radiotherapy system according to claim 1, wherein: The internal radiotherapy system further includes a sleeve, and the bag can be accommodated in the sleeve.

Images