Self-expanding and balloon-expanding stent combination

Abstract

The invention provides a self-expanding and balloon expanding type stent combination and a stent module, the stent module is arranged in a blood vessel and used for supporting the blood vessel, and a balloon space is formed in the stent module; the balloon is arranged in the balloon space and is in elastic contact with the stent module; the balloon can be expanded by itself, so that the stent module is expanded together. The self-expanding and balloon-expanding stent combination provided by the invention can be safely fixed through a proper stent, and the risks of stent displacement, fracture and vascular injury are reduced to the greatest extent.

Description

Technical Field

[0001] The invention relates to the field of medical stents, and in particular to a combination of a self-expanding stent and a balloon-expanding stent. Background Art

[0002] Stenting is the treatment of choice for aortic coarctation in adults and children; despite its widespread use, several challenges remain in optimizing outcomes for these patients. Key issues include selecting the appropriate stent for safe fixation and maximal aortic dilation while reducing the risk of stent migration, fracture, and vessel injury, as well as addressing descending aortic aneurysms while relieving aortic coarctation. Combining a self-expanding and balloon-expandable stent is critical. Summary of the invention

[0003] The object of the present invention is to provide a combination of a self-expanding and balloon-expandable stent, which has the advantages of overall stability and reduced risk of stent displacement or migration.

[0004] To achieve the above-mentioned purpose, the present invention provides a combination of a self-expanding and balloon-expandable stent, a stent module, wherein the stent module is arranged in a blood vessel to support the blood vessel, and has a balloon space inside; a balloon, wherein the balloon is arranged in the balloon space and is in elastic contact with the stent module; the balloon can expand itself to achieve expansion of the stent module.

[0005] Preferably, the stent module includes: a stent body, which is arranged in a blood vessel to support the blood vessel; a coated stent, which is arranged in contact with the inner surface of the stent body, has a balloon space inside and is in elastic contact with the balloon; the balloon can expand itself, and the stent body can be expanded together with the coated stent.

[0006] Preferably, the support module is formed by connecting a plurality of metal rows in sequence; each metal row is formed by connecting a plurality of "Z"-shaped metal wires in sequence.

[0007] Preferably, the connection of the "Z"-shaped metal wires is laser welded.

[0008] Preferably, the support module is made of platinum-iridium alloy wire.

[0009] Preferably, the surface of the support module is covered with a layer of porous polytetrafluoroethylene tubular material with elongation properties to form a coating.

[0010] Preferably, the balloon is a double-layer balloon structure, the inner balloon and the outer balloon are independent of each other, the diameter of the inner balloon is 1 / 2 of the diameter of the outer balloon, and the length is 1 cm shorter than the outer balloon.

[0011] Preferably, during the expansion process, the inner balloon is first filled to initially expand the stent module; then the outer balloon is filled to further evenly expand the stent module.

[0012] In summary, compared with the prior art, the combination of a self-expanding stent and a balloon-expandable stent provided by the present invention has the following beneficial effects:

[0013] First, the present invention proposes a combination of a self-expanding stent and a balloon-expandable stent, which can be safely fixed by a suitable stent, thereby minimizing the risks of stent displacement, fracture, and vascular damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 This is a schematic diagram of a combination of a self-expanding stent and a balloon-expandable stent proposed by the present invention.

[0015] Figure 2 It is a schematic diagram of the support body of the present invention.

[0016] Figure 3 Schematic diagram of the stent graft of the present invention.

[0017] Reference numerals:

[0018] 1-stent body, 2-covered stent, 3-balloon, 4-balloon space. DETAILED DESCRIPTION

[0019] The following will be combined with the attached embodiment of the present invention Figure 1 , the technical solutions, structural features, objectives achieved and effects in the embodiments of the present invention are described in detail.

[0020] It should be noted that the drawings are in a very simplified form and use non-precise proportions. They are only used to conveniently and clearly assist in explaining the embodiments of the present invention, and are not used to limit the conditions for the implementation of the present invention. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size, without affecting the effects and purposes that can be achieved by the present invention, should still fall within the scope of the technical content disclosed by the present invention.

[0021] It should be noted that, in the present invention, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only the elements explicitly listed, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0022] like Figure 1 , Figure 2 As shown, a combination of a self-expanding and balloon-expandable stent proposed by the present invention comprises:

[0023] A stent module, which is disposed in a blood vessel and used to support the blood vessel, and has a balloon space 4 inside;

[0024] A balloon 3, which is disposed in the balloon space 4 and is in elastic contact with the stent module;

[0025] The balloon 3 can expand itself, thereby expanding the stent module together.

[0026] like Figure 1 , Figure 2 , Figure 3 As shown, in a specific embodiment, the support module includes:

[0027] A stent body 1, wherein the stent body 1 is disposed in a blood vessel to support the blood vessel;

[0028] The coated stent 2 is arranged to fit the inner surface of the stent body 1, and has a balloon space 4 inside, and is in elastic contact with the balloon 3;

[0029] The balloon 3 can expand itself, and the stent body 1 can be expanded together with the stent graft 2 .

[0030] The support module can be configured as follows:

[0031] Material: The stent body 1 is made of platinum-iridium alloy wire (90% platinum, 10% iridium). Platinum-iridium alloy has good biocompatibility and corrosion resistance and is suitable for long-term implantation in the body.

[0032] Structure: The stent body 1 is formed by connecting a plurality of metal rows in sequence; each metal row is formed by connecting a plurality of "Z"-shaped metal wires in sequence, and the number of "Z"-shaped metal wires in each metal row can be different. By adjusting the number, the expansion force, expansion diameter and shortening rate of the stent module can be affected. The joints are welded with 24K gold laser to ensure the strength and stability of the stent.

[0033] Covered stent 2: The inner surface of the stent body 1 can be covered with a layer of porous polytetrafluoroethylene tubular material with elongation to form a covered stent 2. The material of the covered stent 2 has good biocompatibility and anti-permeability, and can effectively prevent thrombosis and intimal hyperplasia.

[0034] Length: Various lengths of stents are available, such as 1.6mm, 2.2mm, 2.8mm, 3.4mm, 3.9mm, 4.5mm, etc., to meet the treatment needs of different lumens.

[0035] In a specific embodiment, the balloon 3 can be configured as follows:

[0036] Structure: The balloon 3 is a double-layer balloon structure. The inner balloon and the outer balloon are independent of each other, but work together to expand and contract the stent module.

[0037] Diameter: balloons 3 of various diameters are provided, such as 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, etc., to adapt to different lumens diameters.

[0038] Length: balloons 3 of various lengths are provided, such as 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm, 5.5 cm, etc., to meet the expansion requirements of stent modules of different lengths.

[0039] Working principle: The diameter of the inner balloon is 1 / 2 of the outer balloon diameter and 1 cm shorter than the outer balloon. During the expansion process, the inner balloon is first filled to expand the stent module initially; then the outer balloon is filled to further expand the stent evenly to avoid the formation of undesirable shapes such as funnel shape and dumbbell shape.

[0040] Example 1

[0041] The stent body 1 is composed of "Z"-shaped platinum-iridium alloy wires (90% platinum, 10% iridium) arranged in rows. There are 5 "Z"-shaped wires in each row, and the joints are welded by 24K gold laser. The stent is 3.4mm long, and the surface is covered with a layer of porous polytetrafluoroethylene tubular material to form a coated stent 2. The stent is suitable for the treatment of medium-diameter and long lumen stenosis.

[0042] The matching balloon has a diameter of 18mm and a length of 4.0cm. During the expansion process, the inner balloon (9mm in diameter and 3.0cm in length) is first filled to expand the stent initially; then the outer balloon (18mm in diameter and 4.0cm in length) is filled to further evenly expand the stent module.

[0043] Example 2

[0044] The stent body 1 is composed of "Z"-shaped platinum-iridium alloy wires (90% platinum, 10% iridium) arranged in rows. There are 8 "Z"-shaped wires in each row, and the joints are also welded with 24K gold laser. The stent length is 2.2mm, it is a bare stent, and there is no covered stent 2. This stent is suitable for the treatment of luminal stenosis of smaller diameter and length.

[0045] The matching balloon 3 has a diameter of 14 mm and a length of 3.0 cm. During the expansion process, the inner balloon (7 mm in diameter and 2.0 cm in length) is first filled to initially expand the stent; then the outer balloon (14 mm in diameter and 3.0 cm in length) is filled to further evenly expand the stent module.

[0046] Example 3

[0047] The stent body 1 is composed of "Z"-shaped platinum-iridium alloy wires (90% platinum, 10% iridium) arranged in rows. The number of "Z"-shaped wires in each row can be customized according to the patient's specific conditions, and the joints are welded with 24K gold laser. The stent is 4.5mm long and is covered with a layer of porous polytetrafluoroethylene tubular material to form a coated stent 2. The stent is suitable for the treatment of luminal stenosis of larger diameter and length.

[0048] The matching balloon 3 has a diameter of 24 mm and a length of 5.5 cm. During the expansion process, the inner balloon (12 mm in diameter and 4.5 cm in length) is first filled to initially expand the stent; then the outer balloon (24 mm in diameter and 5.5 cm in length) is filled to further evenly expand the stent module.

[0049] The following describes the method of using the present invention

[0050] 1. Preparation of stent module and balloon

[0051] Check the packaging and expiration date: Before surgery, first check whether the packaging of the stent and balloon dilatation system is complete and confirmed to be free of damage or contamination. At the same time, check the expiration date of the product to ensure that it is used within the expiration date.

[0052] Choose the appropriate specifications: According to the patient's specific conditions, such as the diameter, length and stenosis of the lumen, choose the appropriate stent length and balloon diameter and length. Make sure the selected specifications can meet the treatment needs.

[0053] Prepare surgical instruments: Before the operation, prepare all the instruments needed for the operation, including catheters, guide wires, contrast agents, etc., and ensure that all instruments are in good working condition.

[0054] 2. Surgical Procedure

[0055] Angiography: Angiography is used to determine the specific location and extent of lumen stenosis, providing accurate positioning information for subsequent stent implantation.

[0056] Guidewire guidance: Under X-ray fluoroscopy, a guidewire is passed through the stenosis to provide guidance for the delivery of the stent and balloon.

[0057] Delivery of stent: Load the bare stent body 1 on the delivery system and deliver the stent to the narrow part along the guide wire. During the delivery process, maintain the stability of the delivery system to prevent the stent from shifting. After the bare stent body 1 self-expands, similarly deliver the covered stent 2 to the narrowest part.

[0058] Initial expansion: The inner balloon part of the balloon is delivered to the position of the stent graft 2, and the inner balloon is filled to initially expand the stent graft 2. At this time, the filling pressure and time need to be controlled to avoid over-expansion of the stent or damage to the blood vessel wall.

[0059] Uniform expansion: After the initial expansion of the inner balloon, continue to fill the outer balloon to further uniformly expand the stent graft 2. The outer balloon should be filled slowly and evenly to ensure that the stent can completely fit the vessel wall and avoid forming an undesirable shape.

[0060] Device withdrawal: After the stent is successfully expanded and adheres to the vessel wall, the balloon and delivery system are gradually withdrawn. At the same time, contrast agents are used to check the expansion effect of the stent and the patency of the lumen.

[0061] Follow-up treatment: After the operation, the patient is given necessary medication and care to prevent complications such as thrombosis and infection. At the same time, regular follow-up and reexamination are performed to ensure the stability of the stent and the therapeutic effect.

[0062] 3. Notes

[0063] Strictly adhere to aseptic operation: During the operation, the aseptic operation principles should be strictly followed to avoid the occurrence of complications such as infection.

[0064] Control filling pressure and time: When filling the balloon, the filling pressure and time need to be controlled to avoid over-expansion of the stent or damage to the blood vessel wall.

[0065] Closely monitor the patient's condition: During and after the operation, the patient's vital signs and condition changes should be closely monitored, and possible complications should be dealt with in a timely manner.

[0066] The present invention provides a combination of a self-expanding stent and a balloon-expandable stent, which achieves precise expansion of the stent and effective support of the lumen by adjusting the number and arrangement of "Z"-shaped metal wires and the double-layer sac structure of the balloon. The system has good biocompatibility, corrosion resistance and therapeutic effect, and is suitable for the treatment of different lumen stenosis or occlusive diseases.

[0067] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be appreciated that the above description should not be considered as a limitation of the present invention. After reading the above content, it will be apparent to those skilled in the art that various modifications and substitutions of the present invention will occur. Therefore, the protection scope of the present invention should be limited by the appended claims.

Claims

1. A combination of a self-expanding and balloon-expandable stent, characterized in that: A stent module, the stent module is arranged in a blood vessel and used to support the blood vessel, and has a balloon space (4) inside the stent module; a balloon (3), the balloon (4) is arranged in the balloon space (4) and is in elastic contact with the stent module; the balloon (3) can expand itself to achieve expansion of the stent module.

2. A combination of a self-expanding and balloon-expandable stent according to claim 1, characterized in that: The stent module comprises: a stent body (1), the stent body (1) being arranged in a blood vessel for supporting the blood vessel; a coated stent (2), the coated stent (2) being arranged in contact with the inner surface of the stent body (1), having a balloon space (4) inside the stent and being in elastic contact with the balloon (3); the balloon (3) can expand itself and expand the stent body (1) together with the coated stent (2).

3. According to the combination of a self-expanding and balloon-expandable stent as described in claim 2, the stent body (1) is formed by a plurality of metal rows connected in sequence; each metal row is formed by a plurality of "Z"-shaped metal wires connected in sequence.

4. A combination of a self-expanding and balloon-expandable stent according to claim 3, characterized in that: The connection of the "Z"-shaped metal wire is laser welded.

5. A combination of a self-expanding and balloon-expandable stent according to claim 4, characterized in that: The stent body (1) is made of platinum-iridium alloy wire.

6. A combination of a self-expanding and balloon-expandable stent according to claim 5, characterized in that: The coated stent (2) is a porous polytetrafluoroethylene tubular material with elongation properties, forming a coating.

7. A combination of a self-expanding and balloon-expandable stent according to claim 6, characterized in that: The balloon (3) is a double-layered balloon structure, wherein the inner balloon and the outer balloon are independent of each other, the inner balloon has a diameter of 1 / 2 of the outer balloon diameter, and is 1 cm shorter than the outer balloon.

8. A combination of a self-expanding and balloon-expandable stent according to claim 7, characterized in that: During the expansion process, the inner balloon is first inflated to initially expand the stent module; then the outer balloon is inflated to further evenly expand the stent module.

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