Anti-displacement tracheal stent and human body implantation method

Abstract

The invention provides an anti-displacement tracheal stent and a human body implantation method, solves the problem that the tracheal stent is easy to deviate and misplace in the prior art, limits the whole stent body in human tissues through a positioning bulge, avoids displacement of the tracheal stent, and comprises a sleeve-shaped stent body, a connecting column extending outwards is arranged on the outer side wall of the support body, a positioning protrusion is arranged at the outer end of the connecting column, and the cross section area of the positioning protrusion is larger than that of the connecting column. The stent body, the connecting columns and the positioning protrusions are formed by integrally weaving silk threads made of memory metal materials and covering the silk threads with films.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to the field of tracheal stents, specifically to a tracheal stent designed to prevent displacement and a method for its placement in the human body. Background Technology

[0002] As we all know, air enters and exits the lungs through the bronchi during respiration. Inflammatory granulomas, scars, tuberculosis, trauma, tracheomalacia, amyloidosis, tumors, and other lesions can cause tracheal and bronchial stenosis, leading to symptoms such as dyspnea, wheezing, and choking. In severe cases, respiratory failure can occur, endangering life. Additionally, some cancer patients may develop tracheoesophageal fistulas or tracheomediastinal fistulas, resulting in uncontrollable infections. Tracheal stent placement is one of the important methods for treating airway stenosis and tracheal fistulas, which can quickly relieve breathing difficulties and improve clinical symptoms.

[0003] Metal stents are widely used clinically for tracheal stenosis and tracheal fistulas, with satisfactory results. However, stent migration is a relatively common complication, especially for stents in the high tracheal segment near the glottis, where stent displacement from its original position is more likely, rendering the stent unable to fulfill its original function of supporting the trachea or sealing the fistula. Currently, there is no good clinical solution. Summary of the Invention

[0004] This invention provides a tracheal stent and a method for implanting it in the human body to prevent displacement, which solves the problem of easy displacement of tracheal stents in the prior art. The stent body is limited by a positioning protrusion in the human tissue to prevent displacement of the tracheal stent.

[0005] This invention is achieved through the following technical solution: A tracheal stent for preventing displacement includes a sleeve-shaped stent body, the outer side wall of the stent body is provided with an outwardly extending connecting post, the outer end of the connecting post is provided with a positioning protrusion, and the cross-sectional area of ​​the positioning protrusion is larger than the cross-sectional area of ​​the connecting post. The bracket body, connecting column, and positioning protrusion are integrally woven and coated with memory metal material threads.

[0006] Furthermore, the positioning convex is a disc-shaped structure.

[0007] Furthermore, the connecting column is a tubular structure.

[0008] Furthermore, the length of the bracket body (1) ranges from 30mm to 120mm, and the diameter ranges from 12mm to 22mm; the length of the connecting column (2) ranges from 2mm to 5mm, and the diameter ranges from 1mm to 2mm; the cross-sectional diameter of the positioning protrusion (3) ranges from 10mm to 20mm.

[0009] Furthermore, the shape memory metal material is a nickel-titanium alloy.

[0010] A method for inserting a tracheal stent into a human body, as described above, includes the following steps: S10. Preparations before insertion; S101. Insert the guide wire from the top of the support body, and then pass through the connecting post and the positioning protrusion in sequence; S102. Compress and store the connecting post and positioning protrusion together into the auxiliary conduit; S103. Compress the stent body and the auxiliary catheter together and store them inside the main tube; S20. A guide hole is formed by piercing the neck of the human body, and the guide hole extends from the tracheal wall to the skin surface; S30. Insert the guidewire from inside the mouth into the trachea, and then control the lower end of the guidewire to pass through the guide hole and move to the skin surface. S40. Control the main tube and guidewire to be inserted into the trachea of ​​the human body together, while controlling the lower end of the guidewire to be pulled outward. S50. When the stent body reaches a specific position in the trachea, control the main tube to retract, exposing the lower segment of the tracheal stent and the auxiliary tube. S60. Control the guidewire so that the auxiliary catheter, connecting post, and positioning protrusion enter the guide hole simultaneously. Then, the auxiliary catheter is pulled out from the outside, and the connecting post and positioning protrusion expand and are positioned in the subcutaneous tissue of the neck under their own performance. S70. Continue to retract the main tube to expose the entire stent body, allowing the stent body to expand and support itself within the human trachea.

[0011] Furthermore, in step S20, a percutaneous dilator is inserted into the airway in advance to form a guide hole (6), the diameter of which is about 3 mm. Furthermore, in step S20, in step S70, the outer sheath of the stent implanter is retracted to release the main stent.

[0012] Furthermore, in step S102, the inner diameter of the auxiliary conduit (5) is 2 mm. Furthermore, in step S102, the connecting post and the positioning protrusion are compressed and inserted into the auxiliary conduit.

[0013] The beneficial effects achieved by this invention compared with the prior art are as follows: 1. In the anti-displacement tracheal stent of the present invention, the stent body, connecting column and positioning protrusion are integrally woven from the wire of shape memory metal material. The positioning protrusion is used to position the stent in the human tissue, thereby limiting the entire stent body and avoiding the problem of tracheal stent displacement due to human movement. This invention provides a method for implanting a tracheal stent that prevents displacement. The method allows the tracheal stent to be implanted into the human body. The method is simple and convenient to operate and ensures that the positioning convex ... 2. The positioning protrusion has a disc-shaped structure, and its cross-sectional area is larger than that of the connecting column, thereby ensuring that the positioning protrusion can be stably positioned within human tissue. 3. The shape memory metal material is coated with nickel-titanium alloy, giving the entire tracheal stent excellent shape memory properties. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the tracheal stent described in this invention; Figure 2 This is a schematic diagram of the tracheal stent described in this invention housed inside the main tube; Figure 3 This is a schematic diagram illustrating the initial insertion of the tracheal stent described in this invention into the human body; Figure 4 for Figure 3 Enlarged diagram of part A in the middle; Figure 5 This is a schematic diagram of the tracheal stent placed in the human body according to the present invention; In the diagram: 1. Stent body, 2. Connecting column, 3. Positioning protrusion, 4. Guide wire, 5. Auxiliary catheter, 6. Guide hole, 7. Main tube. Detailed Implementation

[0015] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0016] In the description of the invention, it should be understood that the terms "front," "rear," "upper," "lower," "left," and "right," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the invention. The invention will be further described below with reference to the accompanying drawings and embodiments.

[0017] Example 1 This embodiment discloses a tracheal stent that prevents displacement, such as Figure 1As shown, the support includes a sleeve-shaped support body 1. The outer wall of the support body 1 has an outwardly extending connecting post 2, which is a tubular structure. The outer end of the connecting post 2 has a positioning protrusion 3, the cross-sectional area of ​​which is larger than that of the connecting post 2. The support body 1, the connecting post 2, and the positioning protrusion 3 are integrally woven and coated with shape memory metal threads. In this embodiment, the shape memory metal material is, but is not limited to, a nickel-titanium alloy.

[0018] In this embodiment, the support body 1 has a length of 50mm and a diameter of 12mm; the connecting column 2 has a length of 3mm and a diameter of 2mm. The positioning protrusion 3 has a disc-shaped structure and a cross-sectional diameter of 10mm.

[0019] Based on the above-mentioned anti-displacement tracheal stent, this embodiment also discloses a method for inserting a tracheal stent into the human body, characterized by comprising the following steps: S10. Preparations before insertion; S101, such as Figure 2 As shown, the guide wire 4 is inserted from the top of the support body 1, and then passes through the connecting post 2 and the positioning protrusion 3 in sequence; S102. Compress the connecting post 2 and the positioning protrusion 3 together and store them into the auxiliary conduit 5; In this embodiment, the inner diameter of the auxiliary catheter 5 is 3 mm; S103. Compress the stent body 1 and the auxiliary catheter 5 together and store them in the main tube 7; The stent body 1 needs to be pre-inserted into the outer sheath of the stent implanter, which is a standard technique and will not be described in detail here. S20. A guide hole 6 is formed by piercing the neck of the human body. The guide hole 6 extends from the tracheal wall to the skin surface. To facilitate drilling, this embodiment uses a percutaneous application expander to drill into the airway to form a guide hole 6, the diameter of which is approximately 3mm. S30, such as Figure 3 As shown, guidewire 4 is inserted from the mouth of the human body and enters the trachea. Then, the lower end of guidewire 4 is controlled to pass through guide hole 6 and move to the skin surface. S40, control the main tube 7 and guide wire 4 to be inserted into the trachea of ​​the human body together, and at the same time control the lower end of the guide wire 4 to be pulled outward. S50. When the stent body reaches a specific position in the trachea, control the main tube 7 to retract, exposing the lower section of the tracheal stent and the auxiliary tube 5. S60, such as Figure 5 As shown, the guide wire 4 is controlled so that the auxiliary catheter 5, the connecting post 2, and the positioning protrusion 3 enter the guide hole 6 simultaneously. Then, the auxiliary catheter 5 is pulled out from the outside, and the connecting post 2 and the positioning protrusion 3 expand and are positioned in the neck tissue of the human body under their own performance. S70. Continue to retract the main guide tube 7 to expose the entire stent body, allowing the stent body to expand and support itself within the human trachea. In this step, when retracting the main tube 7, the outer sheath of the stent implanter of the stent body 1 is retracted, so that the stent body 1 is released and expands as a whole to support the trachea of ​​the human body.

[0020] The above method allows for the placement of a tracheal stent into the human body. The procedure is simple and convenient, ensuring that the positioning protrusion can be positioned within the tissue, thus enabling the entire tracheal stent to be stably placed into the human body.

[0021] Example 2 In this embodiment, the support body 1 has a length of 80mm and a diameter of 15mm; the connecting column 2 has a length of 5mm and a diameter of 2mm. The positioning protrusion 3 has a disc-shaped structure with a cross-sectional diameter of 20mm.

[0022] Based on the above-mentioned anti-displacement tracheal stent, this embodiment also discloses a method for inserting a tracheal stent into the human body, characterized by comprising the following steps: S10. Preparations before insertion; S101. Insert the guide wire 4 from the top of the support body 1, and then pass it through the connecting post 2 and the positioning protrusion 3 in sequence. S102. Compress the connecting post 2 and the positioning protrusion 3 together and store them into the auxiliary conduit 5; The inner diameter of the auxiliary catheter 5 is 3 mm.

[0023] S103. Compress the stent body 1 and the auxiliary catheter 5 together and store them in the main tube 7; S20. A guide hole 6 is formed by piercing the neck of the human body. The guide hole 6 extends from the tracheal wall to the skin surface. A guide hole 6 is formed by percutaneously using a dilator to enter the airway and pierce it. The diameter of the guide hole 6 is about 3mm. S30. Insert the guidewire 4 from inside the mouth and into the trachea, then control the lower end of the guidewire 4 to pass through the guide hole 6 and move to the skin surface. S40, control the main tube 7 and guide wire 4 to be inserted into the trachea of ​​the human body together, and at the same time control the lower end of the guide wire 4 to be pulled outward. S50. When the stent body reaches a specific position in the trachea, control the main tube 7 to retract, exposing the lower section of the tracheal stent and the auxiliary tube 5. S60, control the guidewire 4 so that the auxiliary catheter 5, the connecting post 2, and the positioning protrusion 3 enter the guide hole 6 simultaneously. Then, the auxiliary catheter 5 is pulled out from the outside, and the connecting post 2 and the positioning protrusion 3 expand and are positioned in the neck tissue of the human body under their own performance. S70. Continue to retract the main guide tube 7 to expose the entire stent body, allowing the stent body to expand and support itself within the human trachea.

Claims

1. A shift-preventing tracheal stent, characterized in that The bracket includes a sleeve-shaped support body (1), the outer side wall of the support body (1) is provided with an outwardly extending connecting column (2), the outer end of the connecting column (2) is provided with a positioning protrusion (3), and the cross-sectional area of ​​the positioning protrusion (3) is larger than the cross-sectional area of ​​the connecting column (2). The bracket body (1), connecting column (2) and positioning protrusion (3) are integrally woven and coated with memory metal material threads.

2. The tracheal stent of claim 1, wherein, The positioning convex (3) has a disc-shaped structure.

3. The tracheal stent of claim 2, wherein, The connecting column (2) is a tubular structure.

4. The tracheal stent of claim 2, wherein, The length of the bracket body (1) ranges from 30mm to 120mm, and the diameter ranges from 12mm to 22mm; the length of the connecting column (2) ranges from 2mm to 5mm, and the diameter ranges from 1mm to 2mm; the cross-sectional diameter of the positioning protrusion (3) ranges from 10mm to 20mm.

5. The tracheal stent of any one of claims 1-4, wherein, The shape memory metal material is a nickel-titanium alloy.

6. A method of placing a tracheal stent in a human body according to any one of claims 1 to 5, wherein Includes the following steps: S10. Preparations before insertion; S101. Insert the guide wire (4) from the top of the support body (1) and then pass through the connecting post (2) and the positioning protrusion (3) in sequence. S102. Compress the connecting post (2) and the positioning protrusion (3) together and store them into the auxiliary conduit (5); S103. Compress the stent body (1) and the auxiliary catheter (5) together and store them in the main tube (7); S20. A guide hole (6) is formed by piercing the neck of the human body, the guide hole (6) extending from the tracheal wall to the skin surface; S30. Insert the guidewire (4) into the glottis of the human body and into the trachea, and then control the lower end of the guidewire (4) to pass through the guide hole (6) and move to the skin surface. S40, control the main tube (7) and guide wire (4) to be inserted into the trachea of ​​the human body together, and at the same time control the lower end of the guide wire (4) to be pulled outward; S50. When the stent body reaches a specific position in the trachea, control the main tube (7) to retract, exposing the lower section of the tracheal stent and the auxiliary tube (5). S60, control the guidewire (4) so ​​that the auxiliary catheter (5), connecting post (2), and positioning protrusion (3) enter the guide hole (6) simultaneously. Then, the auxiliary catheter (5) is pulled out from the outside, and the connecting post (2) and positioning protrusion (3) expand and are positioned in the subcutaneous tissue of the neck of the human body under their own performance. S70. Continue to retract the main tube (7) to expose the entire stent body and allow the stent body to expand and support itself inside the human trachea.

7. The method of claim 6, wherein the tracheal stent is implanted in the body by, In step S20, a guide hole (6) is formed by percutaneously applying a dilator to the airway and drilling a hole. The diameter of the guide hole (6) is about 3mm-4mm.

8. The method of claim 6, wherein the tracheal stent is implanted in the body by, In step S20, in step S70, when retracting the main tube (7), the outer sheath of the stent implanter of the stent body (1) is retracted, so that the stent body (1) is released and expands as a whole to support the trachea of ​​the human body.

9. The method of claim 6, wherein the tracheal stent is implanted in the body by, In step S102, the inner diameter of the auxiliary catheter (5) is 2 mm.

10. The method for inserting a tracheal stent into a human body according to any one of claims 6-9, characterized in that, In step S102, the connecting column (2) and the positioning protrusion (3) are compressed and installed into the auxiliary conduit (5).

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