Silicone stents carrying radioactive particles and implantation kit assembly

Abstract

This utility model relates to the field of medical devices, specifically to a silicone stent carrying radioactive particles and its implantation assembly, including: an outer sheath, a push rod, an operating rod, a balloon, a guidewire, and a silicone stent. The combination of the silicone stent and the particles in this utility model not only physically solves problems such as respiratory obstruction and insufficient blood supply caused by tracheal and bronchial stenosis due to inflammatory granulomas, scars, tumors, etc., but also provides radiation therapy for the patient's tumor, fundamentally curing the patient. Simultaneously, it solves the problem of particle displacement and loss caused by the inability of metal stents to better fix the radioactive particles, resulting in damage to healthy parts of the patient. It is simple to operate and convenient to use.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and more specifically, to a silicone stent carrying radioactive particles and an implantation kit assembly. Background Technology

[0002] Inflammatory granulomas, scars, tumors, and other lesions causing tracheal and bronchial stenosis often lead to breathing difficulties and insufficient blood supply, which can be life-threatening in severe cases. Airway stent placement is an effective treatment for central airway stenosis. Airway stents include non-metallic stents, metallic stents, and hybrid stents. Silicone stents were the first type of airway stent developed, offering advantages such as low cost and good biocompatibility, making them suitable for treating stenosis and lesions in the trachea and bronchi. Long-term clinical studies have shown that silicone stents have significantly fewer long-term complications, such as granulation tissue hyperplasia and scar stenosis, compared to metallic stents. They also offer advantages such as ease of removal after long-term placement. Therefore, silicone stents are recommended for treating complex post-tracheal intubation tracheal stenosis and post-tracheostomy tracheal stenosis. However, silicone stents can also stimulate granulation tissue hyperplasia. Silicone stent placement is also indicated for patients with malignant airway stenosis who are expected to have a longer survival time. However, silicone stents cannot directly inhibit tumor growth, and tumor growth may lead to obstruction of the upper and lower edges of the stent.

[0003] However, existing silicone stents have high tension, requiring placement in a specific pusher and the use of a rigid bronchoscope during release. They also require general anesthesia to ensure ventilation, and release is done blindly using measurement methods. This makes placement difficult, the surgery challenging, and can cause some damage to the patient's airway. As a result, silicone stent implantation carries significant risks, thus limiting its applicability. Summary of the Invention

[0004] To address the aforementioned problems, the purpose of this invention is to provide a silicone stent carrying radioactive particles and an implantation kit assembly.

[0005] The objective of this utility model is achieved through the following technical solution:

[0006] This utility model provides a silicone stent carrying radioactive particles and an implantation kit assembly, including: an outer tube, a push rod, an operating rod, a balloon, a guide wire, and a silicone stent;

[0007] The operating lever is slidably sleeved inside the push rod and extends out of the front and rear ends of the push rod. The push rod is slidably sleeved inside the outer sleeve and extends out of the rear end of the outer sleeve. The operating lever has a guidewire channel and an tracheal channel. The guidewire is slidably set inside the guidewire channel and extends out of the front and rear ends of the operating lever. The front end of the operating lever is sequentially equipped with a balloon and a silicone stent. The balloon is a non-compliant balloon and is connected to the tracheal channel.

[0008] When not deployed, the balloon and silicone stent are housed within the front end of the outer tube. The front end of the push rod is equipped with a top platform for pushing the silicone stent and for use with the imaging ring. Several particle chambers are provided on the silicone stent, and the particle chambers are filled with radioactive particles.

[0009] Furthermore, the silicone stent includes a straight silicone stent and a Y-type silicone stent. The Y-type silicone stent includes a straight silicone stent and two branch tubes connected to the straight silicone stent.

[0010] Furthermore, the cylindrical silicone support has several rows of conical nails and several rows of particle chambers axially distributed on it.

[0011] Furthermore, several pressure relief holes are provided at the junction of the straight-tube silicone stent and the two branch tubes.

[0012] Furthermore, several particle chambers are distributed along the axial direction of the straight-cylinder silicone support. Each particle chamber is a cylindrical cavity, with a particle placement channel at one end. The entrance to the particle placement channel is sloping, and the bottom of the slope is a particle baffle to prevent the radioactive particles from slipping out. The cylindrical cavity is filled with radioactive particles.

[0013] Furthermore, the outer tube is a flexible and supportive transparent tube with length markings, a handle at the rear end of the outer tube, and a handle stop at the rear end of the handle.

[0014] Furthermore, the push rod has bending characteristics and pushing force, the front end of the push rod has a clearance space for receiving the balloon and retracting, the rear end of the push rod is provided with a push handle, and the front and rear ends of the push handle are provided with push handle stops.

[0015] Furthermore, the front end of the operating lever is a conical guide head made of silicone material that is integrated into the sleeve. The bottom of the guide head is cylindrical, and its outer edge is equivalent to the inner diameter of the outer sleeve, so it can be inserted into the outer sleeve.

[0016] Furthermore, an operating handle is provided at the rear end of the operating lever, an anti-slip edge is provided at the rear end of the operating handle, an airway interface communicating with the tracheal channel is provided on the operating handle, and a flap is provided on the operating handle to connect the operating handle and the airway interface.

[0017] Furthermore, the guidewire is a metal guidewire with a soft tip coated with a hydrophilic layer, and the middle and tail ends are elastic and supportive.

[0018] This invention relates to a silicone stent carrying radioactive particles and its implantation kit assembly. The combination of the silicone stent and the particles not only physically solves problems such as respiratory distress and insufficient blood supply caused by tracheal and bronchial stenosis due to inflammatory granulomas, scars, tumors, etc., but also provides radiation therapy for the patient's tumor, fundamentally curing the patient. Simultaneously, it solves the problem of particle displacement and loss caused by the inability of metal stents to effectively fix the radioactive particles, resulting in damage to healthy parts of the patient. The procedure is simple, convenient, and practical. Attached Figure Description

[0019] The accompanying drawings, which are included to provide a further understanding of the present invention and form part of this application, illustrate exemplary embodiments of the present invention and, together with the description thereof, serve to explain the present invention and do not constitute an undue limitation thereof. In the drawings:

[0020] Figure 1 This is a cutaway view of the overall structure of the silicone stent carrying radioactive particles and the implantation kit of this utility model;

[0021] Figure 2 This is a cross-sectional view of the overall structure of the silicone stent carrying radioactive particles and the implantation kit of this utility model.

[0022] Figure 3 This is a cutaway view of the internal structure of the silicone stent and implantation kit assembly carrying radioactive particles according to this utility model.

[0023] Figure 4 This is a diagram showing the usage status of the silicone stent carrying radioactive particles and the implantation kit assembly of this utility model;

[0024] Figure 5 This is a structural diagram of the straight-cylinder silicone stent in the silicone stent carrying radioactive particles and implantation kit assembly of this utility model;

[0025] Figure 6 This is a structural diagram of the Y-type silicone stent in the silicone stent carrying radioactive particles and the implantation kit assembly of this utility model;

[0026] Figure 7 This is a structural diagram of the particle compartment in the silicone stent carrying radioactive particles and the implantation kit assembly of this utility model;

[0027] The attached diagrams are labeled as follows: 1. Outer tube; 2. Push rod; 3. Operating rod; 4. Balloon; 5. Guide wire; 6. Silicone stent; 7. Top platform; 8. Particle chamber; 9. Radioactive particles; 10. Release hole; 11. Particle placement channel; 12. Particle baffle; 13. Outer tube handle; 14. Outer tube handle baffle; 15. Clearance space; 16. Push handle; 17. Push handle baffle; 18. Guide head; 19. Operating handle; 20. Anti-slip edge; 21. Airway interface; 22. Wing; 23. Main pulmonary tube; 24. Pulmonary bronchus; 25. Conical nail. Detailed Implementation

[0028] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of the present invention.

[0029] like Figures 1 to 7 As shown, addressing the drawback of silicone stent 6, which only physically clears the airway but cannot inhibit tumor growth, this invention incorporates radioactive particles 9 into the silicone stent 6. This allows for effective treatment of the tumor while simultaneously clearing the airway. This invention also provides a method for loading the silicone stent 6 onto a flexible bronchoscope and a delivery device for its placement.

[0030] The present invention relates to a silicone stent carrying iodine-125 radioactive particles and an implantation kit assembly, comprising a silicone stent delivery device and a silicone stent assembly carrying radioactive particles 9.

[0031] The silicone stent delivery system consists of, from the outside in, an outer tube 1, a push rod 2, an operating rod 3, and a guide wire 5. The outer tube 1 is a relatively soft and supportive transparent tube with thin walls. Length markings are printed along the axial direction of the tube wall, with numerical labels. The length markings begin at the guide head 18 and end at the outer tube handle 13. The outer tube 1 is 26cm-43cm long and has a diameter of 8.5mm-14mm. Depending on the diameter of the human trachea, it can be further subdivided into various models. The outer tube 1 has an integrally fitted outer tube handle 13 at its end, with the inner diameter of the handle 13 matching that of the outer tube 1. The outer tube handle 13 is an 8-12cm cylindrical tube with a thicker wall than the outer tube 1. The front end of the outer tube handle 13, from 4cm to the connection with the outer tube 1, has a conical tapering transition. The rear end of the outer tube handle 13 has an annular circular outer tube handle stop 14 that is larger than the outer diameter of the outer tube handle 13, which makes it easier for doctors to hold and operate the tube and prevents it from slipping out of their hands.

[0032] Inside the outer tube 1 is the push rod 2, a cylindrical tube with an outer diameter roughly equal to the inner diameter of the outer tube 1, extending from front to back. The push rod 2 can move smoothly axially within the outer tube 1. The push rod 2 has a thicker wall, providing strong support force and a degree of flexibility. The inner diameter of the tube through which the push rod 2 passes is smaller, and the push rod 2 is slightly longer than the outer tube 1. A clearance space 15, formed by the enlarged inner diameter of the push rod 2, is provided 2cm from the front end to the rear end to accommodate the balloon 4 during retraction.

[0033] The front end of the push rod 2 is inlaid with a one-piece molded metal top platform 7. The metal top platform 7 provides a rigid pushing platform when the push rod 2 acts on the silicone stent 6, and also serves as a contrast ring to determine whether the silicone stent 6 is properly positioned. The rear end of the push rod 2 is a push handle 16, which is slightly thicker than the push rod 2. The push handle 16 is 8-12cm long, and has push handle stops 17 at the front and rear for easier gripping and operation by the doctor.

[0034] Inside the push rod 2 is the operating rod 3. The operating rod 3 is a thin tube that runs through the push rod 2 and the outer sleeve 1. An airway channel is embedded within the tube between the inner and outer walls of the operating rod 3. A guide wire 5 channel is also provided through the center of the operating rod 3. The front end of the operating rod 3 is a silicone conical guide head 18 that is integrally fitted onto the tube. The conical guide head 18 has a 3-5mm long cylinder at its base, with its outer edge matching the inner diameter of the outer sleeve 1, allowing it to fit inside the outer sleeve 1. The maximum outer diameter of the conical portion at the front end of the cylinder is the same as that of the outer sleeve 1. The tip of the conical portion has an outlet for the guide wire 5 channel.

[0035] Behind the conical guide head 18, on the operating lever 3, there is a non-compliant balloon 4 for supporting the silicone stent 6. Inside the balloon 4, on the operating lever 3, is an airway outlet. The balloon's function is to help the silicone stent 6 regain its elasticity when it cannot expand the tracheal wall, allowing it to be more quickly fixed within the trachea. At the end of the operating lever 3 is an operating handle 19, which is cylindrical and slightly thicker than the operating lever 3. The end of the operating handle 19 has a non-slip edge 20. At approximately a 45° angle, the operating handle 19 has a cylindrical airway interface 21, the end of which is a syringe connector. A flap 22 connects the operating handle 19 and the cylindrical airway interface 21 at the angle. The flap 22 serves both to fix the airway interface 21 and to improve the grip of the operating handle 19. The tracheal passage extends from the airway interface 21 along the inside of the operating rod 3 to the inside of the balloon 4, allowing the balloon 4 to be inflated or deflated to expand the silicone stent 6.

[0036] A metal guide wire 5 runs through the guide wire channel inside the operating lever 3. The tip of the metal guide wire 5 is made of a soft material and coated with a hydrophilic layer, while the middle and tail ends have good elasticity and support. The function of the guide wire 5 is to better guide the silicone support 6 to the designated position.

[0037] The silicone stent assembly includes a cylindrical silicone stent 6 carrying radioactive particles 9 and a Y-shaped silicone stent 6 carrying radioactive particles 9. The cylindrical silicone stent 6 is a straight cylinder with a wall thickness of 1-2 mm and a length of 6-15 mm, which can be cut to any size according to actual use. Four rows of conical nails 25 are evenly distributed along the axial direction of the straight cylinder on the outer wall of the silicone stent 6 to secure it to the outer wall of the trachea and prevent displacement of the silicone stent 6. Between every two rows of conical nails 25, there is a row of particle chambers 8. The four rows of particle chambers 8 are also arranged along the axial direction of the tube wall. The particle chambers 8 are completely set inside the tube wall of the silicone stent 6, and the spacing between each particle chamber 8 is 5 mm. The cavity of the particle chamber 8 is a 0.8 × 5 mm cylindrical cavity, and the front end of the cylindrical cavity has a particle placement channel 11 that opens outward at an angle to the outer wall of the silicone stent 6. The opening of the particle placement channel 11 is 0.2 mm wide. The opening of the particle placement channel 11 is smaller than the particle diameter, and the bottom surface of the sloping opening has a particle baffle 12 to prevent the particles from moving outward. Due to the elastic deformation properties of the silicone scaffold 6, the particles will not slip or be lost after being placed in the particle chamber 8. Since the silicone scaffold 6 is surrounded by particle chambers 8, doctors can flexibly arrange the required number and position of particles according to the patient's condition, achieving precise radiotherapy.

[0038] The Y-shaped silicone stent 6 is derived from the cylindrical silicone stent 6, based on the position and shape of the main pulmonary duct 23 and the two pulmonary bronchi 24. The outer walls of the three tubes of the Y-shaped silicone stent 6 have evenly distributed conical studs 25 and particle chambers 8, with the two thinner tubes having three rows of particle chambers 8. At the junction of the two thinner and thicker tubes, there are stress relief holes 10 penetrating the tube wall to reduce stress at the connection points of the Y-shaped silicone stent 6, making the two tubes more suitable for the branching angles of the pulmonary bronchi 24, preventing discomfort to the patient due to differences in the branching angles of the two tubes of the Y-shaped stent compared to the bifurcation angles of the pulmonary bronchi 24. The particle chambers 8 on all three tubes of the Y-shaped silicone stent 6 are designed to meet the treatment needs of tumors in various parts of the pulmonary ducts.

[0039] How to use the silicone stent and implantation kit assembly of this utility model:

[0040] 1. Remove the silicone stent 6 and trim it to the required length according to the patient's pathological characteristics.

[0041] 2. Calculate the required number of particles for the radiation dose based on the size of the patient's tumor. With proper radiation protection in place, load the required particles into the particle chamber 8 of the silicone stent 6.

[0042] 3. Remove the silicone bracket conveyor, push the push rod 2 out of the front end of the outer tube 1, and push the operating rod 3 out of the push rod 2 so that the distance between the guide head and the push rod 2 is equal to the length of the cut silicone bracket 6.

[0043] 4. Place the silicone support 6 loaded with particles onto the corresponding operating rod 3 between the guide head and the push rod 2, ensuring that the air bladder on the operating rod 3 is completely enclosed by the silicone support 6. Then place the silicone support 6 on the filling device, and use the compression of the filling device to place the outer tube 1 onto the compressed silicone support 6 to complete the filling.

[0044] 5. Insert the delivery device containing the silicone stent 6 into the patient's airway. With the aid of the imaging device, observe the location of the lesion corresponding to the imaging ring at the front end of the push rod 2 to determine the position where the silicone stent 6 needs to be released. After confirming the accuracy, hold the outer cannula handle 13 with one hand and the push rod handle 16 with the other. Push the push rod 2 to push the silicone stent 6 out of the outer cannula 1. When the silicone stent 6 is completely freed from the restraint of the outer cannula 1, it will be secured to the tracheal wall by its own elasticity. Then, connect the syringe to the airway interface 21 at the end of the operating rod 3, push the syringe forward, and push gas into the air bladder at the front end of the operating rod 3. The expansion of the air bladder will fully support the silicone stent 6 and firmly secure it to the tracheal wall.

[0045] 6. First, pull out the operating lever 3 and retract it into the push rod 2. Then, pull out the push rod 2 and retract it into the outer sleeve 1. Finally, pull out the whole thing. The release procedure of the silicone bracket 6 is complete.

[0046] The beneficial effects of this utility model of silicone stent and implantation kit assembly are as follows:

[0047] 1. The combination of silicone stent 6 and radioactive particles not only physically resolves breathing difficulties and insufficient blood supply caused by tracheal and bronchial stenosis due to inflammatory granulomas, scars, tumors, and other lesions, but also provides radiation therapy to the patient's tumor, fundamentally curing the patient. Simultaneously, it solves the problem of particle displacement and loss caused by the inability of metal stents to effectively fix radioactive particles, which can damage healthy parts of the patient.

[0048] 2. The particle chambers 8 are evenly distributed around the wall of the silicone stent 6, which allows doctors to flexibly release the required number of particles according to the location and area of ​​the cancer, combined with the position of the corresponding silicone stent 6, and to conduct precise radiotherapy, effectively avoiding radiation damage to healthy tissues.

[0049] 3. The particle chamber 8 of the silicone stent 6 uses a single particle chamber 8 as an independent unit, which solves the problems of long and narrow particle chambers 8 being difficult to place particles and difficult to judge the particle spacing. The slanted opening at the front of the particle chamber 8 has a diameter smaller than the particle diameter, and the bottom surface of the slanted opening has a particle baffle 12 to prevent particle displacement. This makes placement easy and avoids poor treatment effect and harm to normal tissues caused by particle displacement and loss during particle therapy.

[0050] 4. The evenly distributed tapered nails 25 on the outer wall of the silicone stent 6, due to the relatively soft nature of the silicone stent 6, will not damage the inner wall of the trachea when placed on it, and will firmly fix the position of the silicone stent 6, effectively avoiding the displacement problem of the silicone stent 6. The effect is much better than that of cylindrical nails.

[0051] 5. At the junction of the two thin and thick tubes of the Y-shaped stent, there are stress relief holes 10 penetrating the tube wall. This is to reduce the stress at the connection point of the Y-shaped silicone stent 6, so that the branching angle of the two tubes is more suitable to the branching angle of the pulmonary bronchi, and the patient will not feel uncomfortable due to the different bifurcation angle between the Y-shaped stent and the pulmonary bronchi, thus reducing the patient's pain.

[0052] 6. The use of a flexible bronchoscope to deploy the silicone stent 6 overcomes the drawbacks of using a rigid bronchoscope, which requires general anesthesia to ensure ventilation, involves blind placement based on measurement methods, is difficult to perform, has a high surgical complexity, and can cause some damage to the patient's airway. This significantly reduces the risks associated with silicone stent 6 implantation, thereby expanding its applicability, reducing the workload of doctors, and providing patients with a better medical experience.

[0053] 7. The front end of the push rod 2 is inlaid with an integrally formed metal top platform 7. The metal top platform 7 provides a rigid pushing platform when the push rod 2 acts on the silicone bracket 6, and can also serve as a developing ring to determine whether the placement of the silicone bracket 6 is appropriate.

[0054] 8. The combination of the guide head 18, operating lever 3, and cuff simplifies the doctor's procedure, allowing for a single release and easy completion of the entire process. The guide head 18 easily guides the bronchoscope through the epipharynx, avoiding damage to the glottis and other parts of the trachea. The cuff helps the silicone stent 6 regain its elasticity and fix itself in the trachea more quickly when the stent 6 cannot expand the congested tracheal wall. This reduces the doctor's workload and alleviates the patient's discomfort.

[0055] The above description is only a preferred embodiment of the present utility model. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present utility model, and these improvements and modifications should also be considered within the protection scope of the present utility model.

Claims

1. A silicone stent carrying radioactive seeds and an implant kit assembly, characterized in that, include: Outer tube, push rod, operating lever, balloon, guide wire, silicone stent; The operating rod is slidably sleeved inside the push rod and extends out of the front and rear ends of the push rod. The push rod is slidably sleeved inside the outer sleeve and extends out of the rear end of the outer sleeve. The operating rod has a guidewire channel and an tracheal channel. The guidewire is slidably disposed in the guidewire channel and extends out of the front and rear ends of the operating rod. The front end of the operating rod is sequentially provided with the balloon and the silicone stent. The balloon is a non-compliant balloon and is connected to the tracheal channel. When not deployed, the balloon and silicone stent are housed within the front end of the outer tube. The front end of the push rod is provided with a top platform for pushing the silicone stent and for use with the imaging ring. The silicone stent is provided with several particle chambers, and the particle chambers are filled with radioactive particles.

2. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The silicone stent includes a straight silicone stent and a Y-type silicone stent. The Y-type silicone stent includes the straight silicone stent and two branch tubes connected to the straight silicone stent.

3. The radioparticle-carrying silicone stent and implant kit assembly of claim 2, wherein, The cylindrical silicone support has several rows of conical nails and several rows of particle chambers axially distributed on it.

4. The radioparticle-carrying silicone stent and implant kit assembly of claim 2, wherein, The straight-tube silicone support has several pressure relief holes at the junction with the two branch pipes.

5. The radioparticle-carrying silicone stent and implant kit assembly of claim 2, wherein, Several particle chambers are distributed along the axial direction of the cylindrical silicone support. Each particle chamber is a cylindrical cavity. One end of the cylindrical cavity is a particle placement channel. The entrance of the particle placement channel is sloping. The bottom of the slope is a particle baffle to prevent the radioactive particles from slipping out. The cylindrical cavity is filled with radioactive particles.

6. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The outer tube is a flexible and supportive transparent tube with length markings. A handle is provided at the rear end of the outer tube, and a handle stop is provided at the rear end of the handle.

7. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The push rod has bending characteristics and pushing force. The front end of the push rod has a clearance space for receiving the balloon retraction. The rear end of the push rod is provided with a push handle. The front and rear ends of the push handle are provided with push handle stops.

8. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The front end of the operating lever is a conical guide head made of silicone material that is sleeved together. The bottom of the guide head is cylindrical, and its outer edge is approximately the same as the inner diameter of the outer sleeve, so that it can be sleeved into the outer sleeve.

9. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The operating lever is provided with an operating handle at its rear end, the operating handle is provided with an anti-slip edge at its rear end, the operating handle is provided with an airway interface communicating with the tracheal channel, and the operating handle is provided with a wing connecting the operating handle and the airway interface.

10. The radioparticle-carrying silicone stent and implant kit assembly of claim 1, wherein, The guidewire is a metal guidewire, the front end of the guidewire is made of a soft material and coated with a hydrophilic layer, and the middle and tail ends are elastic and supportive.

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