An integrated membrane-covered branch tracheal stent and a manufacturing method thereof

Abstract

The present invention relates to the technical field of tracheal stents, and discloses an integrated coated branch tracheal stent and a manufacturing method thereof, comprising a main tracheal silicone sleeve, the side surfaces of the left bronchial silicone sleeve and the right bronchial silicone sleeve are both provided with second through holes, and the bottom of the main tracheal silicone sleeve, the bottom of the left bronchial silicone sleeve and the bottom of the right bronchial silicone sleeve are all fixed with second memory metals. In the process of extending the integrated coated branch tracheal stent into the human body, the first memory metal and the second memory metal can be bent and deformed, and after the device is installed, the power-on columns on the contacts and the second memory metal are powered on, and the first memory metal and the second memory metal are automatically restored, thereby automatically opening the main tracheal silicone sleeve, the left bronchial silicone sleeve and the right bronchial silicone sleeve, so that the device can better open the human trachea and make the patient breathe more smoothly.

Description

Technical Field

[0001] The present invention relates to the technical field of tracheal stents, and in particular to an integrated membrane-covered branch tracheal stent and a manufacturing method thereof. Background Art

[0002] When people breathe, air enters and exits the lungs through the bronchi. The bronchi are like branches, with large bronchi divided into small bronchi. At the end of the smallest bronchi, there are air sacs, where oxygen in the air is absorbed by the human body to sustain life, and carbon dioxide is expelled from the body. Tracheal and bronchial stenosis caused by inflammatory granulomas, scars, tuberculosis, trauma, tracheomalacia, amyloidosis, tumors and other lesions can cause obstructive pneumonia, atelectasis and dyspnea. Patients experience symptoms such as dyspnea, wheezing, and choking. In severe cases, respiratory failure may occur and endanger life. Tracheal stent placement is one of the important means to treat airway stenosis, which can quickly relieve dyspnea and improve clinical symptoms. The application of airway stents can be traced back to the 1890s. In the past 20 years, with the continuous development of materials science and the popularization of flexible bronchoscopes in clinical practice, airway stent placement has been widely used in clinical practice, providing opportunities for further treatment and improving the quality of life of patients.

[0003] The Y-shaped stent fully conforms to the anatomical structure of the tracheal carina, with an original main body and two-branch design. The stent and tracheal carina fit perfectly and will not shift or deform, which is beneficial to breathing and the discharge of sputum. The stent coating can reduce irritation and block fistula, keeping the airway open for a long time. The Y-shaped design can complete the treatment of multiple lesions in the carina at one time, reduce the incidence of surgical complications, reduce the difficulty of surgery, and reduce costs. Some stents are partially or fully covered.

[0004] The supporting force of the end of the existing one-piece coated branch tracheal stent is average. After the stent is placed in the human body, since the side of the stent is completely a mesh structure, adhesion is easily generated between the stent and the trachea, and the complete mesh structure will also affect the supporting effect of the stent. In view of the above problems, the existing equipment needs to be improved. Summary of the invention

[0005] The object of the present invention is to provide an integrated coated branch tracheal stent and a method for manufacturing the same, so as to solve the problem that the supporting force of the end of the existing integrated coated branch tracheal stent proposed in the above background technology is general. After the stent is placed in the human body, since the side of the stent is completely a mesh structure, adhesion is easily generated between the stent and the trachea, and the complete mesh structure will also affect the supporting effect of the stent.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solutions: an integrated coated branch tracheal stent and a manufacturing method thereof, comprising a main trachea silicone sleeve, a first through hole being provided on the side of the main trachea silicone sleeve, a supporting mechanism being fixed inside the top of the main trachea silicone sleeve, the supporting mechanism comprising a first memory metal, a contact being fixed on an inner wall of the first memory metal, and an inflation channel being provided on the contact.

[0007] A connecting silicone sleeve is fixed to the bottom of the main trachea silicone sleeve, and a left bronchial silicone sleeve and a right bronchial silicone sleeve are symmetrically fixed on both sides of the bottom of the connecting silicone sleeve. A second through hole is opened on the side of the left bronchial silicone sleeve and the side of the right bronchial silicone sleeve, and a second memory metal is fixed in the bottom of the main trachea silicone sleeve, the bottom of the left bronchial silicone sleeve, and the bottom of the right bronchial silicone sleeve.

[0008] Preferably, six groups of the first through holes are provided, and the six groups of first through holes are evenly distributed circumferentially on the main air pipe silicone sleeve.

[0009] Preferably, a support block is fixed in the inflation channel, and one side of the support block is connected to the magnetic block through a tension spring, and stop blocks are fixed to the inner top and inner bottom of the inflation channel, and the magnetic block rests on the two stop blocks.

[0010] Preferably, the second through holes are evenly distributed circumferentially on the left bronchial silicone sleeve and the right bronchial silicone sleeve.

[0011] Preferably, an annular channel and a branch channel are provided in the side wall of the main airway silicone sleeve, and the annular channel is connected to the bottom of the inflation channel, and the top of the branch channel is connected to the annular channel. A groove is provided on the outer side of the main airway silicone sleeve, and the groove is connected to the branch channel, and an airbag is fixed in the groove.

[0012] A method for manufacturing an integrated coated branch tracheal stent comprises the following steps:

[0013] S1. Place the first memory metal and the second memory metal at both ends of the main air pipe mold respectively, heat the silicone liquid and place it in the mold, cool and form it, and then extract the blocking wire in the first memory metal to generate an annular channel and a branch channel in the silicone sleeve of the main air pipe. Then, fix the airbag on the surface of the groove by a thermoforming machine to obtain the silicone sleeve of the main air pipe, and then open the first through holes with equal spacing on the silicone sleeve of the main air pipe by a hole opening device;

[0014] S2, placing the second memory metal at the bottom of the two bronchial molds respectively, heating the silicone liquid and placing it into the molds, cooling and forming, to obtain the left bronchial silicone sleeve, and then using a hole-opening device to open second through holes with equal spacing on the left bronchial silicone sleeve and the right bronchial silicone sleeve, and the right bronchial silicone sleeve is made in the same way;

[0015] S3. Connect the main trachea silicone sleeve, the connecting silicone sleeve, the left bronchial silicone sleeve and the right bronchial silicone sleeve together by a hot-melt machine to make an integrated coated branch tracheal stent.

[0016] Compared with the prior art, the invention has the following beneficial effects: the integrated membrane-covered branch tracheal stent,

[0017] 1. The integrated coated branch tracheal stent can achieve the purpose of convenient placement and automatic expansion. When the device is extended into the human body, the first memory metal and the second memory metal can be bent and deformed. After the device is placed, the power-on column on the contact and the second memory metal is energized, and the first memory metal and the second memory metal automatically recover, thereby automatically expanding the main tracheal silicone sleeve, the left bronchial silicone sleeve and the right bronchial silicone sleeve, so that the device can better expand the human trachea and make the patient breathe more smoothly.

[0018] 2. The integrated coated branch tracheal stent can achieve the purpose of stable and firm installation. After completing the installation operation of the device, the inflation device with an electromagnet is inserted into the main trachea silicone sleeve and aligned with the inflation channel. After the electromagnet is energized, the electromagnet attracts the magnetic block, which moves to the right and leaves the inflation channel. The inflation channel opens, and then air is inflated into the inflation channel. The gas is finally filled into the groove, and the airbag expands and presses against the trachea, making the device more stable and firm to install.

[0019] 3. The integrated coated branch tracheal stent can achieve the purpose of reducing adhesion and achieving good supporting effect. The first through hole is segmentedly opened on the main trachea silicone sleeve, which can reduce the adhesion between the tracheal mucosa and the main trachea silicone sleeve and increase the supporting effect of the main trachea silicone sleeve. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0021] Figure 2 It is a schematic diagram of the front cross-sectional structure of the present invention;

[0022] Figure 3 This is a schematic diagram of the connection structure between the first memory metal and the contact point of the present invention;

[0023] Figure 4 It is a schematic diagram of a top-view cross-sectional structure of the present invention;

[0024] Figure 5 For the present invention Figure 2 The enlarged structural diagram at A in the middle;

[0025] Figure 6 For the present invention Figure 3Enlarged structural diagram at B in the middle.

[0026] In the figure: 1. Main bronchial silicone sleeve; 2. First through hole; 3. Support mechanism; 301. First memory metal; 302. Contact; 303. Inflation channel; 304. Support block; 305. Tension spring; 306. Magnetic block; 307. Stopper; 4. Connecting silicone sleeve; 5. Left bronchial silicone sleeve; 6. Right bronchial silicone sleeve; 7. Second through hole; 8. Second memory metal; 9. Annular channel; 10. Branch channel; 11. Groove; 12. Airbag. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0028] See also Figure 1-6 The present invention provides a technical solution: an integrated coated branch tracheal stent, comprising a main tracheal silicone sleeve 1, a first through hole 2 is opened on the side of the main tracheal silicone sleeve 1, a supporting mechanism 3 is fixed inside the top of the main tracheal silicone sleeve 1, the supporting mechanism 3 comprises a first memory metal 301, a contact 302 is fixed on an inner wall of the first memory metal 301, and an inflation channel 303 is opened on the contact 302.

[0029] A connecting silicone sleeve 4 is fixed to the bottom of the main trachea silicone sleeve 1, and a left bronchial silicone sleeve 5 and a right bronchial silicone sleeve 6 are symmetrically fixed on both sides of the bottom of the connecting silicone sleeve 4. A second through hole 7 is opened on the side of the left bronchial silicone sleeve 5 and the side of the right bronchial silicone sleeve 6, and a second memory metal 8 is fixed in the bottom of the main trachea silicone sleeve 1, the bottom of the left bronchial silicone sleeve 5, and the bottom of the right bronchial silicone sleeve 6.

[0030] In this embodiment, Figure 1 As shown, six groups of first through holes 2 are provided, and the six groups of first through holes 2 are evenly distributed circumferentially on the main air pipe silicone sleeve 1. The six groups of first through holes 2 evenly distributed circumferentially can make the supporting effect of the main air pipe silicone sleeve 1 better.

[0031] In this embodiment, Figure 2 , Figure 3 , Figure 5 and Figure 6As shown, a support block 304 is fixed in the inflation channel 303, and one side of the support block 304 is connected to the magnet 306 through a tension spring 305, and blocks 307 are fixed to the inner top and inner bottom of the inflation channel 303, and the magnet 306 rests on the two blocks 307, and the blocks 307 have a blocking effect on the magnet 306. When the magnet 306 is attracted to the right by the energized electromagnet, the tension spring 305 is stretched, the magnet 306 leaves the inflation channel 303, and the inflation channel 303 is opened. Subsequently, an external tool can be used to inflate the inflation channel 303. After the inflation is completed, the electromagnet is powered off, and the magnet 306 automatically rebounds into the inflation channel 303 under the action of the tension spring 305, and the inflation channel 303 is automatically closed.

[0032] In this embodiment, Figure 1 As shown, the second through holes 7 are evenly distributed circumferentially on the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6. The circumferentially evenly distributed second through holes 7 can make the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6 form a mesh to support the left bronchus and the right bronchus of the human body.

[0033] In this embodiment, Figure 2 , Figure 4 and Figure 5 As shown, an annular channel 9 and a branch channel 10 are provided in the side wall of the main airway silicone sleeve 1, and the annular channel 9 is connected with the bottom of the inflation channel 303, and the top of the branch channel 10 is connected with the annular channel 9. A groove 11 is provided on the outer side of the main airway silicone sleeve 1, and the groove 11 is connected with the branch channel 10. An airbag 12 is fixed in the groove 11. When the inflation channel 303 is inflated, the gas can enter the groove 11 through the annular channel 9 and the branch channel 10, and the airbag 12 expands and presses against the trachea, so that the supporting stability effect is better.

[0034] According to another aspect of the present invention, a method for manufacturing an integrated coated branch tracheal stent is provided, comprising the following steps:

[0035] S1, respectively placing the first memory metal 301 and the second memory metal 8 at both ends of the main airway mold, heating the silicone liquid and placing it in the mold, and after cooling and molding, extracting the blocking wire in the first memory metal 301, so that an annular channel 9 and a branch channel 10 are generated in the main airway silicone sleeve 1, and then fixing the airbag 12 on the surface of the groove 11 by a thermoforming machine to obtain the main airway silicone sleeve 1, and then opening the first through holes 2 with equal spacing on the main airway silicone sleeve 1 by a hole opening device;

[0036] S2, placing the second memory metal 8 at the bottom of the two bronchial molds respectively, heating the silicone liquid and placing it into the molds, cooling and molding, obtaining the left bronchial silicone sleeve 5, and then using a hole-opening device to open second through holes 7 with equal spacing on the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6, and the right bronchial silicone sleeve 6 is made in the same way;

[0037] S3. Connect the main trachea silicone sleeve 1, the connecting silicone sleeve 4, the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6 together by a hot melt machine to make an integrated coated branch tracheal stent.

[0038] When in use, the device is first inserted into the human bronchus, the main bronchial silicone sleeve 1 is in the main bronchus, the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6 are in the left bronchus and the right bronchus respectively. In the process of placing the device, the first memory metal 301 and the second memory metal 8 can be bent and deformed, and the second memory metal 8 is provided with a power-on column. After the contact 302 and the power-on column are energized, the first memory metal 301 and the second memory metal 8 are restored to their original shapes, thereby opening the main bronchial silicone sleeve 1, the left bronchial silicone sleeve 5 and the right bronchial silicone sleeve 6, and then the first memory metal 301 and the second memory metal 8 are connected. Then, the inflation device with the electromagnet is inserted into the main trachea silicone sleeve 1 and the electromagnet is aligned with the magnetic block 306. After the electromagnet is energized, the electromagnet attracts the magnetic block 306, and the magnetic block 306 moves to the right and leaves the inflation channel 303, and the inflation channel 303 is opened. Then, the inflation device is used to inflate the inflation channel 303, and the airbag 12 eventually expands and presses against the human body, thereby improving the stability of the device. Subsequently, the electromagnet is powered off, and the magnetic block 306 automatically bounces back into the inflation channel 303, and the inflation channel 303 is automatically closed, thus completing the entire work.

[0039] In summary, the integrated coated branch tracheal stent and the manufacturing method thereof achieve the purposes of convenient placement, automatic expansion, stable and firm installation, reduced adhesion and good supporting effect, thus meeting people's usage needs.

[0040] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An integrated coated branch tracheal stent, comprising a main tracheal silicone sleeve (1), characterized in that: A first through hole (2) is provided on the side of the main air pipe silicone sleeve (1), a support mechanism (3) is fixed inside the top of the main air pipe silicone sleeve (1), the support mechanism (3) comprises a first memory metal (301), a contact point (302) is fixed on an inner wall of the first memory metal (301), and an inflation channel (303) is provided on the contact point (302); A connecting silicone sleeve (4) is fixed to the bottom of the main trachea silicone sleeve (1), and a left bronchial silicone sleeve (5) and a right bronchial silicone sleeve (6) are symmetrically fixed on both sides of the bottom of the connecting silicone sleeve (4), and a second through hole (7) is provided on the side of the left bronchial silicone sleeve (5) and the side of the right bronchial silicone sleeve (6), and a second memory metal (8) is fixed in the bottom of the main trachea silicone sleeve (1), the bottom of the left bronchial silicone sleeve (5), and the bottom of the right bronchial silicone sleeve (6).

2. The integrated coated branch tracheal stent according to claim 1, characterized in that: Six groups of the first through holes (2) are provided, and the six groups of first through holes (2) are evenly distributed in the circumferential direction on the main air pipe silicone sleeve (1).

3. The integrated coated branch tracheal stent according to claim 1, characterized in that: A support block (304) is fixed inside the inflation channel (303), and one side of the support block (304) is connected to a magnetic block (306) via a tension spring (305). Blocks (307) are fixed to the inner top and inner bottom of the inflation channel (303), and the magnetic block (306) rests against the two block blocks (307).

4. The integrated coated branch tracheal stent according to claim 1, characterized in that: The second through holes (7) are evenly distributed in the circumferential direction on the left bronchial silicone sleeve (5) and the right bronchial silicone sleeve (6).

5. The integrated coated branch tracheal stent according to claim 1, characterized in that: An annular channel (9) and a branch channel (10) are provided in the side wall of the main airway silicone sleeve (1), and the annular channel (9) is connected to the bottom of the inflation channel (303), and the top of the branch channel (10) is connected to the annular channel (9). A groove (11) is provided on the outer side of the main airway silicone sleeve (1), and the groove (11) is connected to the branch channel (10), and an air bag (12) is fixed in the groove (11).

6. A method for manufacturing an integrated coated branch tracheal stent, applied to an integrated coated branch tracheal stent according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1, placing the first memory metal (301) and the second memory metal (8) at the two ends of the main airway mold respectively, heating the silicone liquid and placing it in the mold, and after cooling and molding, extracting the blocking wire in the first memory metal (301), so that an annular channel (9) and a branch channel (10) are generated in the main airway silicone sleeve (1), and then fixing the airbag (12) on the surface of the groove (11) by a thermoforming machine to obtain the main airway silicone sleeve (1), and then opening the first through holes (2) with equal spacing on the main airway silicone sleeve (1) by a hole opening device; S2, placing the second memory metal (8) at the bottom of the two bronchial molds respectively, heating the silicone liquid and placing it in the molds, cooling and molding, and obtaining the left bronchial silicone sleeve (5), and then using a hole-opening device to open second through holes (7) with equal spacing on the left bronchial silicone sleeve (5) and the right bronchial silicone sleeve (6), and the right bronchial silicone sleeve (6) is made in the same way; S3. Connect the main trachea silicone sleeve (1), the connecting silicone sleeve (4), the left bronchial silicone sleeve (5) and the right bronchial silicone sleeve (6) together by a hot melt machine to form an integrated coated branch tracheal stent.

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