Zero exchange balloon catheter stent system with distal protective umbrella and method of use

Abstract

The invention relates to a zero-exchange balloon catheter stent system with a far-end protective umbrella and a using method, and belongs to the technical field of medical instruments. Comprising a balloon catheter and a stent system which are connected, the stent system comprises a conveying system and a stent; the conveying system comprises a control core wire; the center of the control core wire is provided with a connecting binding wire fixing hole and a connecting binding wire releasing point; the support comprises a near-end support, a connecting area and a far-end protective umbrella, and the connecting area is located between the near-end support and the far-end protective umbrella; the connecting area comprises a connecting binding wire, a protective umbrella wire binding ring and a protective umbrella connecting wire. The far-end protection umbrella and the near-end support are designed to be a separable combination, instrument exchange is not needed in the operation process, the operation process is simplified, the operation difficulty is reduced, the operation time is shortened, and therefore the risk of complications such as ischemic stroke is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of building medical devices, and in particular to a zero-exchange balloon catheter stent system with a distal protective umbrella and a method of use. Background Art

[0002] As a minimally invasive interventional treatment, carotid angioplasty and stenting have been widely used to treat carotid stenosis and plaques, effectively improving blood perfusion of organs in the neck blood vessel supply area. In China, the popularity of carotid artery stenting (CAS) has even surpassed traditional carotid endarterectomy (CEA) and has become the preferred option for treating carotid stenosis.

[0003] In order to ensure the safety of surgery, the distal carotid artery protection device (disposable embolic protection umbrella) is widely used in vascular interventional surgery. Its main function is to prevent plaque debris and emboli from escaping, protect the distal blood vessels from the risk of embolism, and ensure the safety of the surgical process.

[0004] However, traditional surgical procedures usually require the use of three types of devices: balloon catheters, stents, and distal protective umbrellas. This leads to complex surgical operations, long instrument exchange time, and increased risks of complications such as ischemic stroke. In addition, the use of multiple instruments also increases surgical costs, placing a burden on patients and the medical insurance system.

[0005] In order to solve the above problems, some patents (such as CN201595959U, CN201010262495.7, CN202011312549.6) have proposed a separate embolic protector for cerebrovascular protection. However, when performing carotid artery stenosis surgery, stents are still needed for treatment, and the device exchange step cannot be completely avoided.

[0006] Therefore, the prior art still has the following problems: Long instrument exchange time increases the risk of complications: Traditional surgical procedures require multiple instrument exchanges, which prolongs the operation time and increases the risk of complications such as ischemic stroke.

[0007] High surgical costs: The use of multiple instruments increases surgical costs, placing a burden on patients and the medical insurance system.

[0008] Complex operation: The instrument exchange process is complicated, which increases the difficulty of surgical operation.

[0009] In order to solve the above problems, the present application provides a zero-exchange balloon catheter stent system with a distal protective umbrella. The system designs the protective umbrella and the stent as a detachable combination to achieve zero-exchange operation, simplify the surgical process, reduce the risk of complications, shorten the operation time, and reduce surgical costs. Summary of the invention

[0010] The zero-exchange balloon catheter stent system with distal protection umbrella and the use method provided by the present application adopt the following technical solutions: A zero-exchange balloon catheter stent system with a distal protective umbrella, comprising a balloon catheter and a stent system; The balloon catheter is connected to the stent system; The stent system comprises a delivery system and a stent; The conveying system comprises a control core wire; a connection wire fixing hole and a connection wire release point are provided at the center of the control core wire; The stent comprises a proximal stent, a connection area and a distal protection umbrella, the distal end of the proximal stent is a closed-loop structure, the proximal end of the distal protection umbrella is a closed-loop structure, and the connection area is located between the proximal stent and the distal protection umbrella; The connection area includes: A connecting wire, one end of which is fixed in a connecting wire fixing hole, and the other end is fixed at a connecting wire release point; when the connecting wire binds the proximal bracket and the distal protective umbrella, adjacent closed-loop protrusions are staggered and connected; the connecting wire release point can separate the connecting wire from the control core wire, so that the proximal bracket and the distal protective umbrella are separated; after the distal protective umbrella is released, the control core wire can move axially to independently adjust the position of the distal protective umbrella; The protective umbrella cable ring is fixed on the control core wire and has a cable binding hole; The protective umbrella connecting wire has one end fixed on the wire binding hole of the protective umbrella cable ring, and the other end fixed on the protrusion of the proximal closed loop of the braided wire of the distal protective umbrella.

[0011] Furthermore, the balloon catheter comprises a Luer connector, a catheter body and a balloon; the Luer connector is installed at one end of the catheter body to connect to a stent system; and the balloon is installed outside the catheter body.

[0012] Furthermore, the delivery system also includes an inner delivery tube, an outer delivery tube, a support spring, a push-developing ring, and a recovery developing ring installed in the introduction sheath; the inner delivery tube is sleeved on the control core wire; the length of the inner delivery tube is less than the length of the control core wire; the outer delivery tube is sleeved on the inner delivery tube and the distal end is connected to the support spring; the support spring, the push-developing ring, and the recovery developing ring are fixed on the inner delivery tube in sequence; the distal end of the support spring is connected to the proximal end of the push-developing ring; the distal tapered section of the introduction sheath is connected to the tapered end of the Luer connector.

[0013] Furthermore, the bracket also includes a bracket proximal developing ring, a bracket developing wire and a protective umbrella head end; the bracket proximal developing ring is installed on the control core wire; the bracket developing wire is sleeved on the proximal bracket; the protective umbrella head end is connected to the distal protective umbrella.

[0014] Furthermore, the control core wire runs through the stent system, with the distal end reaching the end of the protective umbrella head; the distance between the pushing developing ring and the recovering developing ring is 1.2-1.5 times the length of the proximal developing ring of the stent, so as to accommodate the proximal developing ring of the stent.

[0015] Furthermore, the proximal closed loop of the distal protective umbrella is also connected with a protective umbrella connecting wire.

[0016] Furthermore, the proximal end of the proximal stent is a braided open-loop structure, two adjacent braided wires are twisted to form a primary twisted wire, multiple strands of primary twisted wire are twisted to form a secondary twisted wire, and the proximal developing ring of the stent is connected to the secondary twisted wire.

[0017] Furthermore, the distal protective umbrella has developing wires; the developing wires include an array; and the head end of the protective umbrella is wound with developing material.

[0018] Furthermore, the outer delivery tube is sleeved on the inner delivery tube and connected to the support spring at the far end, and the connection method is any one of glue connection, laser welding or soldering; The proximal ends of the inner delivery tube and the outer delivery tube are aligned and fixedly connected, and the connection method is any one of glue connection, laser welding or soldering; The distal end of the support spring is connected to the proximal end of the push developing ring, and the connection method is any one of glue connection, laser welding or soldering; The recovery developing ring is connected to the inner conveying tube by glue connection, laser welding or soldering.

[0019] Furthermore, the method for using the zero exchange balloon catheter stent system with a distal protective umbrella comprises the following specific steps: S1. After the balloon catheter reaches the lesion through the passage, the stent system is introduced into the balloon catheter, and the stent enters the human body along the balloon catheter. At this time, the balloon has not reached the narrow position of the lesion plaque; S2: The stent system arrives at the lesion site along with the balloon catheter, and the balloon is located at some distance distal to the plaque and is not inflated; S3, keep the stent system still, withdraw the balloon catheter, and release the stent connection wire at the same time, so that the distal protective umbrella is separated from the proximal stent, and the distal protective umbrella is opened after being freed from the restraint of the balloon catheter body. After the distal protective umbrella is released, the control core wire can move axially relative to the delivery inner tube to independently adjust the position of the distal protective umbrella. The protective umbrella is opened by pushing or withdrawing the control core wire, and the balloon position is adjusted to reach the lesion site; S4, balloon filling, vascular reconstruction at the lesion site. During the balloon filling process, plaques or thrombi will be intercepted by the protective umbrella; S5, balloon decompression, adjust the stent position, withdraw the balloon catheter, and open the proximal stent; S6. Push the balloon catheter to the distal end, retract the proximal part of the distal protective umbrella into the balloon catheter, and withdraw the delivery system, protective umbrella, and balloon catheter from the body to complete the operation.

[0020] In summary, this application includes the following beneficial technical effects: 1. No exchange during the operation, and the operation is completed with one instrument introduction: This application designs the distal protective umbrella and the proximal stent as a detachable combination. There is no need to exchange instruments during the operation, which simplifies the surgical process, reduces the difficulty of operation, shortens the operation time, and thus reduces the risk of complications such as ischemic stroke.

[0021] 2. Reusability and cost reduction: Compared with disposable embolic protection umbrellas, the stent system provided in this application can be reused, which reduces surgical costs, alleviates the financial burden on patients, and reduces the pressure on national medical insurance.

[0022] 3. Reduce the use of instruments and reduce radiation dose: This application integrates the distal protective umbrella and the proximal bracket into a system, which reduces the number of instruments used, reduces the radiation dose of the surgeon and the patient, and improves the safety of the operation.

[0023] 4. Improve surgical efficiency: Simplified surgical procedures and zero-exchange operations improve surgical efficiency, shorten operation time, and enable patients to recover faster.

[0024] 5. The protective umbrella and the stent work together to improve the treatment effect: The synergistic effect of the distal protective umbrella and the proximal stent can better protect the distal blood vessels, prevent the risk of embolism, and effectively support the blood vessels to improve the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of the structure of an embodiment of the present application; Figure 2 is a schematic structural diagram of a support system according to an embodiment of the present application; Figure 3 It is a schematic diagram of the structure of the connection area of ​​an embodiment of the present application; Figure 4 This is a schematic diagram of the proximal twisted wire structure of the proximal stent in an embodiment of the present application; Figure 5 This is a schematic diagram of the structure of the stent in an embodiment of the present application, in which the connecting wires are not released and the stent is opened as a whole; Figure 6 This is a diagram of the connection wire release of the embodiment of the present application, and the bracket and the protective umbrella are in the open state; Figure 7 This is a schematic diagram of the structure of the stent system according to the embodiment of the present application entering a human blood vessel along with a balloon catheter; Figure 8This is a schematic diagram of the structure of the stent system according to the embodiment of the present application, which arrives at the distal end of the lesion site along with the balloon catheter; Fig. 9 This is a schematic diagram of the structure of the embodiment of the present application in which the distal protective umbrella is opened and the balloon reaches the lesion site; Fig.10 This is a schematic diagram of the structure of the balloon being inflated and the distal protective umbrella intercepting thrombus or plaque in an embodiment of the present application; Fig.11 This is a schematic diagram of the structure of the proximal stent in the embodiment of the present application being released at the lesion site to support the blood vessel; Fig.12 It is a schematic diagram of the structure of the embodiment of the present application in which the distal braided protective umbrella is retracted into the balloon catheter; Fig.13 It is a schematic diagram of the structure of the stent system and the balloon catheter in the embodiment of the present application being withdrawn from the body.

[0026] Explanation of the reference numerals in the accompanying drawings: 1. stent system; 2. balloon catheter; 3. control core wire; 4. inner delivery tube; 5. outer delivery tube; 6. support spring; 7. push developing ring; 8. proximal developing ring of stent; 9. recovery developing ring; 10. proximal stent; 11. stent developing wire; 12. connection area; 13. introduction sheath; 14. distal protective umbrella; 15. protective umbrella head end; 16. Luer connector; 17. catheter body; 18. balloon; 19. connection wire fixing hole; 20. connection wire release point; 21. connection wire; 22. protective umbrella cable ring; 23. protective umbrella connecting wire; 24. primary torsion wire; 25. secondary torsion wire; 26. blood vessel; 27. plaque. DETAILED DESCRIPTION

[0027] The present application is further described in detail below in conjunction with the accompanying drawings.

[0028] like Figure 1 and Figure 2 A specific embodiment of a zero-exchange balloon catheter stent system with a distal protective umbrella shown includes a balloon catheter 2 and a stent system 1 connected thereto; The stent system 1 comprises a delivery system and a stent; The conveying system includes a control core wire 3; a connection wire fixing hole 19 and a connection wire release point 20 are provided at the center of the control core wire 3; The stent includes a proximal stent 10, a connecting area 12 and a distal protective umbrella 14. The distal end of the proximal stent 10 is a closed-loop structure, and the proximal end of the distal protective umbrella 14 is a closed-loop structure. The connecting area 12 is located between the proximal stent 10 and the distal protective umbrella 14, and is used to separate the proximal stent 10 and the distal protective umbrella 14; the proximal stent 10 can be a woven stent or a laser-cut stent, and the distal protective umbrella 14 can be a woven protective umbrella or a protective umbrella made by laser cutting.

[0029] Specifically, Figure 3 As shown, the connection area 12 includes: A connecting wire 21, one end of which is fixed in a connecting wire fixing hole 19, and the other end is fixed at a connecting wire release point 20; when the connecting wire 21 binds the proximal bracket 10 and the distal protective umbrella 14, adjacent closed-loop protrusions are staggered and connected, thereby avoiding entanglement or jamming of the proximal bracket 10 and the distal protective umbrella 14 during the separation process, thereby ensuring smooth separation operation; the connecting wire release point 20 can be powered on or otherwise disengaged from the connecting wire 21 and the control core wire 3, thereby separating the proximal bracket 10 and the distal protective umbrella 14. After the distal protective umbrella 14 is released, the control core wire 3 can move axially to independently adjust the position of the distal protective umbrella 14; refer to Figure 5 and Figure 6 ; The protective umbrella cable ring 22 is fixed on the control core wire 3 and has a cable binding hole; The protective umbrella connecting wire 23 has one end fixed to the wire binding hole of the protective umbrella cable ring 22, and the other end fixed to the protrusion of the proximal closed loop of the braided wire of the distal protective umbrella 14, ensuring that the distal protective umbrella 14 remains in an expanded state during transportation to avoid collapse or deformation.

[0030] Specifically, when the proximal support 10 and the distal protective umbrella 14 are separated, the protective umbrella connecting wire 23 can help the distal protective umbrella 14 to be smoothly deployed, thereby improving the release efficiency.

[0031] Specifically, the protective umbrella cable ring 22 ensures that the protective umbrella connecting wire 23 remains stable during transportation to avoid falling off or shifting.

[0032] Specifically, the balloon catheter 2 includes a Luer connector 16 , a catheter body 17 and a balloon 18 ; the Luer connector 16 is installed at one end of the catheter body 17 to connect to the stent system 1 ; the balloon 18 is installed outside the catheter body 17 .

[0033] Specifically, the delivery system also includes a delivery inner tube 4, a delivery outer tube 5, a support spring 6, a push developing ring 7, and a recovery developing ring 9 installed in the introduction sheath 13; the delivery inner tube 4 is sleeved on the control core wire 3; the length of the delivery inner tube 4 is less than the length of the control core wire 3; the delivery outer tube 5 is sleeved on the delivery inner tube 4 and the distal end is connected to the support spring 6; the support spring 6, the push developing ring 7, and the recovery developing ring 9 are fixed on the delivery inner tube 4 in sequence; the distal end of the support spring 6 is connected to the proximal end of the push developing ring 7; the distal tapered section of the introduction sheath 13 is connected to the tapered end of the Luer connector 16, which is convenient for introducing the stent system 1 into the balloon catheter 2; the distal end of the delivery inner tube 4 is close to the proximal end of the connection wire fixing hole 19, which is convenient for the doctor to operate when the proximal stent 10 and the distal protective umbrella 14 are separated.

[0034] Specifically, the inner transport tube 4 and the outer transport tube 5 are respectively sleeved on the control core wire 3 to form a pipeline system for guiding and controlling the transport process of the proximal stent 10 and the distal protective umbrella 14 to ensure that the proximal stent 10 and the distal protective umbrella 14 can smoothly reach the lesion site; the support spring 6 can provide a certain supporting force to help the proximal stent 10 and the distal protective umbrella 14 maintain their shape during the transport process to avoid collapse or deformation; the pushing developing ring 7 and the recovering developing ring 9 are respectively located at the proximal and distal ends of the proximal stent 10 and the distal protective umbrella 14, and the positions of the proximal stent 10 and the distal protective umbrella 14 can be clearly displayed under X-ray fluoroscopy to help doctors locate and observe; by pushing or withdrawing the control core wire 3, the release and recovery of the proximal stent 10 and the distal protective umbrella 14 can be controlled, simplifying the surgical operation and improving the surgical efficiency.

[0035] Specifically, after the balloon catheter 2 delivers the balloon 18 to the lesion site along the delivery guidewire, the guidewire is withdrawn, the distal tapered section of the introduction sheath 13 is inserted into the tapered end of the Luer connector 16, and the delivery outer tube 5 and the control core wire 3 are pushed together to introduce the stent into the balloon catheter 2, and then the stent is delivered to the distal end of the balloon catheter 2, and then the stent is released.

[0036] Specifically, the combined stent system provided by the present application, during the operation, firstly passes the balloon catheter 2 through the passage to the lesion site, and then introduces the stent system 1 into the balloon catheter 2, and the stent enters the human body along the balloon catheter 2. After reaching the lesion site, the balloon catheter 2 is withdrawn, and the connecting wire 21 is released at the same time, so that the distal protective umbrella 14 is separated from the proximal stent 100. After the distal protective umbrella 14 is opened, its opening degree is controlled by controlling the core wire 3, and the position of the balloon 18 is adjusted to the lesion site. After the balloon 18 is filled, the blood vessels at the lesion site are reconstructed, and the distal protective umbrella 14 intercepts plaques or thrombi. After the balloon 18 is depressurized, the balloon catheter 2 is withdrawn to open the proximal stent 10. Finally, the distal protective umbrella 14 is recovered, and the delivery system and the balloon catheter 2 are withdrawn from the body to complete the operation.

[0037] In other preferred embodiments, the stent also includes a stent proximal developing ring 8, a stent developing wire 11 and a protective umbrella head 15; the stent proximal developing ring 8 is installed on the control core wire 3, and because it is made of developing material, it can clearly display the position of the proximal stent 10, helping doctors to accurately position the proximal stent 10 at the lesion site and ensure the accuracy of stent implantation; the stent developing wire 11 is sleeved on the proximal stent 10, and the stent developing wire 11 can be used as an indication of the deployment status of the proximal stent 10. When the stent developing wire 11 is clearly displayed, it indicates that the proximal stent 10 has been fully deployed; the protective umbrella head 15 is connected to the distal protective umbrella 14, and the protective umbrella head 15 can provide a certain supporting force to help the protective umbrella maintain an deployed state in the blood vessel to avoid collapse or displacement of the protective umbrella.

[0038] Specifically, the control core wire 3 passes through the stent system 1, and the distal end reaches the end of the protective umbrella head 15; the distance between the pushing developing ring 7 and the recovering developing ring 9 is 1.2-1.5 times the length of the proximal developing ring 8 of the stent, so as to accommodate the proximal developing ring 8 of the stent, and ensure that the proximal developing ring 8 of the stent can pass smoothly during the release process of the proximal stent 10 to avoid jamming or damage.

[0039] Specifically, the distance design between the pushing developing ring 7 and the recovering developing ring 9 can effectively prevent the developing ring 8 at the proximal end of the bracket from shifting during the release process, ensuring that the developing ring 8 at the proximal end of the bracket is always located at the proximal end of the bracket to play its positioning and developing role.

[0040] In other preferred embodiments, the proximal closed loop of the distal protective umbrella 14 is further connected with a protective umbrella connecting wire 23 .

[0041] Specifically, the protective umbrella connecting wire 23 is bound to the position of the proximal closed loop of the distal protective umbrella 14 that is not connected to the connecting wire 21, so as to avoid interference between the bracket connecting wire 21 and the protective umbrella connecting wire 23.

[0042] In other preferred embodiments, Figure 4 As shown, the proximal end of the proximal stent 10 is a braided open-loop structure, two adjacent braided wires are twisted to form a primary twisted wire 24, and multiple strands of primary twisted wires 24 are twisted to form a secondary twisted wire 25. The proximal developing ring 8 of the stent is connected to the secondary twisted wire 25.

[0043] In other preferred embodiments, the distal protective umbrella 14 has developing wires; the developing wires include an array; and the protective umbrella head 15 is wound with developing material.

[0044] Specifically, the developing wire is made of developing material, which can clearly display the position and shape of the distal protective umbrella 14 under X-ray fluoroscopy, helping doctors to observe the opening and retraction of the distal protective umbrella 14 in real time, ensuring that the distal protective umbrella 14 is always located at the distal end of the diseased blood vessel, and effectively intercepting plaques and thrombi; the distribution and shape of the developing wire can help doctors judge the opening direction and size of the protective umbrella, ensuring that the protective umbrella can be fully deployed and cover the diseased blood vessel to avoid omissions; when plaques or thrombi are intercepted by the protective umbrella, the shape and position of the developing wire may change, and doctors can judge the thrombus interception situation by observing the changes in the developing wire and take timely measures.

[0045] Specifically, the protective umbrella head 15 is wound with a developing material, which can clearly display the position of the protective umbrella head 15 under X-ray fluoroscopy, helping doctors to determine whether the distal protective umbrella 14 has been fully opened and ensure that it is located at the distal end of the diseased blood vessel; the developing design of the protective umbrella head 15 can help doctors avoid accidentally injuring the blood vessel wall when retracting the protective umbrella, thereby improving the safety of the operation.

[0046] In other preferred embodiments, the outer delivery tube 5 is sleeved on the inner delivery tube 4 and connected to the support spring 6 at the distal end thereof, and the connection method is any one of glue connection, laser welding or soldering; The proximal ends of the inner delivery tube 4 and the outer delivery tube 5 are aligned and fixedly connected, and the connection method is any one of glue connection, laser welding or soldering; The distal end of the support spring 6 is connected to the proximal end of the push developing ring 7, and the connection method is any one of glue connection, laser welding or soldering; The recovery developing ring 9 and the conveying inner tube 4 are connected by glue connection, laser welding or soldering.

[0047] Specifically, connection methods such as glue connection, laser welding and soldering can ensure that the various components of the delivery system are firmly connected, avoid loosening or falling off during the operation, and ensure that the proximal bracket 10 and the distal protective umbrella 14 can be smoothly delivered and released.

[0048] A method for using a zero exchange balloon catheter stent system with a distal protective umbrella, such as Figure 7-Figure 13 As shown, the specific steps are as follows: S1. After the balloon catheter 2 reaches the lesion site in the blood vessel 26 through the passage, the stent system 1 is introduced into the balloon catheter 2, and the stent enters the human body along the balloon catheter 2. At this time, the balloon 18 has not reached the narrow position of the lesion plaque. Figure 7 ; S2, the stent system 1 arrives at the lesion site along with the balloon catheter 2, and the balloon 18 is located at a distance from the plaque 27. At this time, the balloon 18 is not filled. Figure 8 ; S3, keep the stent system 1 immobile, withdraw the balloon catheter 2, and release the connecting wire 21 at the same time, so that the distal protective umbrella 14 is separated from the proximal stent 10, and the distal protective umbrella 14 is opened after being free from the restraint of the balloon catheter body 17. After the distal protective umbrella 14 is released, the control core wire 3 can move axially relative to the delivery inner tube 4, and the position of the distal protective umbrella 14 can be adjusted independently. The opening of the distal protective umbrella 14 is controlled by pushing or withdrawing the control core wire 3, and the position of the balloon 18 is adjusted to reach the lesion site, refer to Fig. 9 ; S4, balloon 18 is filled, and blood vessels at the lesion are reconstructed. During the filling process of balloon 18, if there is plaque or thrombus, it will be intercepted by the distal protective umbrella 14. Fig.10 ; S5, the balloon 18 is depressurized, the position of the proximal stent 10 is adjusted, and the balloon catheter 2 is withdrawn to open the proximal stent 10. Fig.11 ; S6, push the balloon catheter 2 to the distal end, retract the proximal part of the distal protective umbrella 14 into the balloon catheter 2, and withdraw the delivery system, the distal protective umbrella 14, and the balloon catheter 2 from the body together, completing the operation, refer to Fig.12 and Fig.13 .

[0049] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A zero-exchange balloon catheter stent system with a distal protective umbrella, characterized in that: Including balloon catheters and stent systems; The balloon catheter is connected to the stent system; The stent system comprises a delivery system and a stent; The conveying system comprises a control core wire; a connection wire fixing hole and a connection wire release point are provided at the center of the control core wire; The stent comprises a proximal stent, a connection area and a distal protection umbrella, the distal end of the proximal stent is a closed-loop structure, the proximal end of the distal protection umbrella is a closed-loop structure, and the connection area is located between the proximal stent and the distal protection umbrella; The connection area includes: A connecting wire, one end of which is fixed in a connecting wire fixing hole, and the other end is fixed at a connecting wire release point; when the connecting wire binds the proximal bracket and the distal protective umbrella, adjacent closed-loop protrusions are staggered and connected; the connecting wire release point can separate the connecting wire from the control core wire, so that the proximal bracket and the distal protective umbrella are separated; after the distal protective umbrella is released, the control core wire can move axially to independently adjust the position of the distal protective umbrella; The protective umbrella cable ring is fixed on the control core wire and has a cable binding hole; The protective umbrella connecting wire has one end fixed on the wire binding hole of the protective umbrella cable ring, and the other end fixed on the protrusion of the proximal closed loop of the braided wire of the distal protective umbrella.

2. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 1, characterized in that: The balloon catheter comprises a Luer connector, a catheter body and a balloon; the Luer connector is installed at one end of the catheter body to connect to a stent system; and the balloon is installed outside the catheter body.

3. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 2, characterized in that: The delivery system also includes a delivery inner tube, a delivery outer tube, a support spring, a push developing ring, and a recovery developing ring installed in the introduction sheath; the delivery inner tube is sleeved on the control core wire; the length of the delivery inner tube is less than the length of the control core wire; the delivery outer tube is sleeved on the delivery inner tube and the distal end is connected to the support spring; the support spring, the push developing ring, and the recovery developing ring are fixed on the delivery inner tube in sequence; the distal end of the support spring is connected to the proximal end of the push developing ring; the distal tapered section of the introduction sheath is connected to the tapered end of the Luer connector.

4. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 3, characterized in that: The bracket also includes a bracket proximal developing ring, a bracket developing wire and a protective umbrella head end; the bracket proximal developing ring is installed on the control core wire; the bracket developing wire is sleeved on the proximal bracket; the protective umbrella head end is connected to the distal protective umbrella.

5. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 4, characterized in that: The control core wire runs through the stent system, and the distal end reaches the end of the protective umbrella head; the distance between the pushing developing ring and the recovering developing ring is 1.2-1.5 times the length of the proximal developing ring of the stent, so as to accommodate the proximal developing ring of the stent.

6. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 1, characterized in that: The proximal closed loop of the distal protective umbrella is also connected with a protective umbrella connecting wire.

7. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 5, characterized in that: The proximal end of the proximal stent is a braided open-loop structure, two adjacent braided wires are twisted to form a primary twisted wire, multiple strands of primary twisted wire are twisted to form a secondary twisted wire, and the proximal developing ring of the stent is connected to the secondary twisted wire.

8. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 5, characterized in that: The distal protective umbrella is provided with developing wires; the developing wires include an array; the head end of the protective umbrella is wound with developing material.

9. A zero-exchange balloon catheter stent system with a distal protective umbrella according to claim 5, characterized in that: The outer delivery tube is sleeved on the inner delivery tube and connected to the support spring at the far end thereof, and the connection method is any one of glue connection, laser welding or soldering; The proximal ends of the inner delivery tube and the outer delivery tube are aligned and fixedly connected, and the connection method is any one of glue connection, laser welding or soldering; The distal end of the support spring is connected to the proximal end of the push developing ring, and the connection method is any one of glue connection, laser welding or soldering; The recovery developing ring is connected to the inner conveying tube by glue connection, laser welding or soldering.

10. A method for using a zero exchange balloon catheter stent system with a distal protective umbrella according to any one of claims 1 to 9, characterized in that: The specific steps are as follows: S1. After the balloon catheter reaches the lesion through the passage, the stent system is introduced into the balloon catheter, and the stent enters the human body along the balloon catheter. At this time, the balloon has not reached the narrow position of the lesion plaque; S2: The stent system arrives at the lesion site along with the balloon catheter, and the balloon is located at some distance distal to the plaque and is not inflated; S3, keep the stent system still, withdraw the balloon catheter, and release the stent connection wire at the same time, so that the distal protective umbrella is separated from the proximal stent, and the distal protective umbrella is opened after being freed from the restraint of the balloon catheter body. After the distal protective umbrella is released, the control core wire can move axially relative to the delivery inner tube to independently adjust the position of the distal protective umbrella. The protective umbrella is opened by pushing or withdrawing the control core wire, and the balloon position is adjusted to reach the lesion site; S4, balloon filling, vascular reconstruction at the lesion site. During the balloon filling process, plaques or thrombi will be intercepted by the protective umbrella; S5, balloon decompression, adjust the stent position, withdraw the balloon catheter, and open the proximal stent; S6. Push the balloon catheter to the distal end, retract the proximal part of the distal protective umbrella into the balloon catheter, and withdraw the delivery system, protective umbrella, and balloon catheter from the body to complete the operation.

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