Restraint stent for balloon and using method thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a restraint stent for a balloon and a using method thereof.The restraint stent comprises the balloon, a restraint part is arranged on the outer wall of the balloon, a restraint stent body is arranged on the outer wall of the restraint part, and arc-shaped parts are annularly arranged on the inner wall of the restraint stent body at equal angles; a plurality of arc-shaped pieces are arranged on the inner side of the restraint support, a connecting arc-shaped plate is arranged on the inner side of each arc-shaped piece, a first connecting piece is arranged on one side of each connecting arc-shaped plate, and a second connecting piece is arranged on the other side of each connecting arc-shaped plate. The balloon, the restraining piece and the restraining support extend in the direction of the blood vessel, so that after the balloon is expanded, the whole outer surface of the balloon can be kept cylindrical, the diameter of the two ends of the balloon is not larger than that of the two ends of the restraining support, the blood vessel is not prone to being damaged, and meanwhile the blood vessel wall can bear uniform pressure; and therefore, the possibility of occurrence of a dog bone effect is effectively reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular is a balloon restraint bracket and a use method thereof. Background Art

[0002] The balloon-restrained stent is an effective interventional device that can significantly improve the symptoms and prognosis of patients with cardiovascular diseases. Relevant matters need to be noted when using it to ensure the success of the operation and the safety of the patient. The balloon-restrained stent is usually used in interventional treatment, especially in the treatment of cardiovascular diseases. For example, in the treatment of coronary heart disease, atherosclerosis and other diseases, when the blood vessels are severely blocked, balloon dilatation and stent implantation can be used for treatment. In these operations, the balloon mainly expands physically to temporarily open the narrow lumen, improve blood flow or restore the normal function of the lumen, and the balloon-restrained stent can be used as an auxiliary tool to help doctors expand the balloon more accurately, so that it can expand the blocked blood vessels and keep the blood vessels unobstructed.

[0003] At present, balloon angioplasty usually requires first delivering a balloon and a constrained stent into the diseased blood vessel through a catheter, and then applying pressure to expand the balloon, thereby causing the constrained stent to expand and open the blood vessel. However, the constraint of the constrained stent on the balloon is mainly in the middle of the balloon, and the constraint force on the two ends of the balloon is relatively small, resulting in the diameter of the two ends of the balloon being larger than the diameter of the two ends of the stent after the balloon is expanded, thereby causing excessive expansion of the blood vessel, which can easily cause damage to the blood vessel. At the same time, the blood vessel wall cannot always be subjected to uniform pressure, thereby increasing the possibility of the "dog bone effect". A balloon constrained stent and a method of use thereof are now proposed to solve the above problems. Summary of the invention

[0004] In order to solve the problems raised in the above-mentioned background technology, the present invention provides a balloon-use constrained stent and a method of using the same, which solves the problem that after the balloon is expanded, the diameters at both ends of the balloon will be larger than the diameters at both ends of the stent, which can easily cause damage to the blood vessels and cause uneven pressure on the blood vessel walls, thereby increasing the possibility of the "dog bone effect".

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a constraint bracket for a balloon, comprising a balloon, the outer wall of the balloon is provided with a constraint part, the outer wall of the constraint part is provided with a constraint bracket, the inner wall of the constraint bracket is provided with arc-shaped parts in a circular shape and at equal angles, the inner side of each arc-shaped part is provided with a connecting arc plate, one side of the connecting arc plate is provided with a first connecting piece, the other side of the connecting arc plate is provided with a second connecting piece, and the inner side of the connecting arc plate is provided with a reset spring.

[0006] Preferably, the restraint bracket comprises a main body, both sides of the main body are provided with connecting wires, and one side of the two groups of connecting wires are provided with a connecting part.

[0007] Preferably, one side of one group of the connecting parts is provided with a proximal end portion, one side of the other group of the connecting parts is provided with a distal end portion, and a plurality of restraint rings are provided inside the main body.

[0008] Preferably, each group of the connecting parts is provided in plurality, and the expansion amplitude of the plurality of the connecting parts is consistent with the expansion amplitude of the main body.

[0009] Preferably, the proximal portion is used to constrain the expansion of both ends of the balloon.

[0010] Preferably, the restraint ring is a prismatic structure, and the restraint ring is evenly and annularly or linearly distributed inside the main body.

[0011] Preferably, one end of the return spring is connected to the restraining member, and both ends of the restraining member are welded to both ends of the balloon.

[0012] Preferably, the two ends of the restraining member are used to restrain the expansion of the two ends of the balloon, and one connecting arc plate, one first connecting piece and one second connecting piece form a group.

[0013] Preferably, one side of the first connecting piece is connected to the second connecting piece.

[0014] The present invention also provides a method for using a balloon restraint stent, comprising the following steps:

[0015] Step 1: The balloon, together with the restraint and the restraint bracket, extends along the tube direction of the blood vessel. When reaching the location of the vascular lesion, the balloon is expanded. While the balloon is expanding, the restraint restrains the balloon, and the expansion amplitude of the restraint is the same as the expansion amplitude of the balloon. The restraint pushes the connecting arc plate through the reset spring, so that the first connecting piece and the second connecting piece expand and extend. At the same time, the connecting arc plate pushes the arc-shaped piece, and the arc-shaped piece pushes the main body, so that the main body expands.

[0016] Step 2: When the balloon is expanded, the main body can constrain the middle part of the balloon, and the connecting part can effectively constrain the balloons on both sides of the main body, so that after the balloon is expanded, its outer surface can maintain a cylindrical shape as a whole, so that the blood vessel wall is subjected to uniform pressure, thereby effectively reducing the possibility of the "dog bone effect";

[0017] Step three: after the balloon clears the blocked blood vessel through the expansion of the constraint piece and the constraint stent, and the blood vessel remains unobstructed, the balloon is compressed. At the same time, the constraint piece retracts, and the constraint piece drives the connecting arc plate to move through the reset spring, the first connecting piece and the second connecting piece retract, and the connecting arc plate drives the main body to retract through the arc piece, so that when the balloon is pulled out along the blood vessel, the constraint piece and the constraint stent can be pulled out together.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The present invention is provided with a balloon, a restraining member, a restraining bracket, a first connecting piece, a second connecting piece and other structures, so that the balloon, the restraining member and the restraining bracket are extended along the tube direction of the blood vessel. When the balloon reaches the position of the vascular lesion, the balloon is expanded. While the balloon is expanding, the restraining member restrains the balloon, and the expansion amplitude of the restraining member is the same as the expansion amplitude of the balloon. The restraining member pushes the connecting arc plate through a reset spring, so that the first connecting piece and the second connecting piece are expanded and extended. At the same time, the connecting arc plate pushes the arc-shaped member, and the arc-shaped member pushes the main body to expand the main body. The main body can restrain the middle part of the balloon, and the connecting part can effectively restrain the balloons on both sides of the main body, so that after the expansion of the balloon, the outer surface of the balloon can remain cylindrical as a whole, the diameters of the two ends of the balloon will not be larger than the diameters of the two ends of the restraining bracket, it is not easy to cause damage to the blood vessel, and at the same time, the blood vessel wall can be subjected to uniform pressure, thereby effectively reducing the possibility of the occurrence of the "dog bone effect";

[0020] The present invention is provided with structures such as a balloon, a constraint, a constraint bracket, a reset spring, and a second connecting piece. After the balloon dredges the blocked blood vessel through the expansion of the constraint bracket and the constraint bracket, the blood vessel remains unobstructed, and the balloon is compressed. At the same time, the constraint bracket retracts, and the constraint bracket drives the connecting arc plate to move through the reset spring, the first connecting piece and the second connecting piece retract, and the connecting arc plate drives the main body to retract through the arc-shaped piece, so that when the balloon is pulled out along the blood vessel, the constraint bracket and the constraint bracket can be pulled out together. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the overall positional relationship structure of the present invention;

[0022] Figure 2 It is a schematic diagram of the side position relationship structure of the present invention as a whole;

[0023] Figure 3 For the present invention Figure 2 A schematic diagram of the enlarged relationship structure of the structure at A in the middle;

[0024] Figure 4 It is a schematic diagram of the shrinkage structure of the restraining bracket of the present invention;

[0025] Figure 5 It is a schematic diagram of the expansion structure of the restraining stent of the present invention;

[0026] Figure 6 It is a schematic diagram of the cross-sectional structure of the collapsed balloon of the present invention.

[0027] In the figure: 1. balloon; 2. restraint member; 3. restraint bracket; 301. main body; 302. connecting line; 303. connecting part; 304. proximal end; 305. distal end; 306. restraint ring; 4. return spring; 5. connecting arc plate; 6. first connecting piece; 7. second connecting piece; 8. arc-shaped member. DETAILED DESCRIPTION

[0028] 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.

[0029] like Figures 1 to 6 As shown, the present invention provides a restraining bracket for a balloon, comprising a balloon 1, a restraining member 2 is arranged on the outer wall of the balloon 1, a restraining bracket 3 is arranged on the outer wall of the restraining member 2, an arc-shaped member 8 is arranged on the inner wall of the restraining bracket 3 in a circular shape at equal angles, a connecting arc plate 5 is arranged on the inner side of each arc-shaped member 8, a first connecting piece 6 is arranged on one side of the connecting arc plate 5, a second connecting piece 7 is arranged on the other side of the connecting arc plate 5, and a reset spring 4 is arranged on the inner side of the connecting arc plate 5;

[0030] The above scheme is adopted: by providing a balloon 1, a constraint 2, a constraint bracket 3, a first connecting piece 6, a second connecting piece 7 and other structures, the balloon 1 is extended along the tube direction of the blood vessel together with the constraint 2 and the constraint bracket 3. When the balloon 1 reaches the location of the vascular lesion, the balloon 1 is expanded. While the balloon 1 is expanding, the constraint 2 constrains the balloon 1, and the expansion amplitude of the constraint 2 is the same as the expansion amplitude of the balloon 1. The constraint 2 pushes the connecting arc plate 5 through the reset spring 4, so that the first connecting piece 6 and the second connecting piece 7 are expanded and extended. At the same time, the connecting arc plate 5 pushes the arc-shaped piece 8, and the arc-shaped piece 8 pushes the main body 301, so that the main body 301 expands. The main body 301 can constrain the middle part of the balloon 1, and the connecting part 303 can effectively constrain the balloon 1 on both sides of the main body 301, so that after the expansion of the balloon 1 is completed, its outer surface as a whole can remain cylindrical, so that the blood vessel wall is subjected to uniform pressure, thereby effectively reducing the possibility of the occurrence of the "dog bone effect".

[0031] like Figures 1 to 6As shown, the restraint bracket 3 includes a main body 301, both sides of the main body 301 are provided with connecting wires 302, and one side of the two groups of connecting wires 302 are provided with connecting parts 303;

[0032] One side of one group of connecting parts 303 is provided with a proximal end portion 304, one side of another group of connecting parts 303 is provided with a distal end portion 305, and a plurality of restraint rings 306 are provided inside the main body 301;

[0033] Each group of connection parts 303 is provided in plurality, and the expansion range of the plurality of connection parts 303 is consistent with the expansion range of the main body part 301;

[0034] The proximal portion 304 is used to restrict the expansion of both ends of the balloon 1;

[0035] The restraining ring 306 is a prismatic structure, and the restraining ring 306 is evenly and annularly or linearly distributed inside the main body 301;

[0036] The above scheme is adopted: the main body 301 is pushed by the arc-shaped member 8 to expand the main body 301. When the balloon 1 expands, the main body 301 can constrain the middle part of the balloon 1, and the connecting part 303 can effectively constrain the balloon 1 on both sides of the main body 301, so that after the expansion of the balloon 1, the outer surface of the balloon 1 can remain cylindrical as a whole, and the internal space of the connecting part 303 can expand with the expansion of the balloon 1, so that after the balloon 1 expands, the diameters of the two ends of the balloon 1 will not be larger than the diameters of the two ends of the constraining stent 3, which is not easy to cause damage to the blood vessel, and the blood vessel wall can be subjected to uniform pressure, thereby effectively reducing the possibility of the "dog bone effect";

[0037] The extension and contraction achieved by deformation of each constraint ring 306 in the circumferential direction are uniform, the axial constraint rings 306 expand uniformly with each other, and the force applied by the constraint stent 3 to the blood vessel wall is also uniform, which can avoid the occurrence of blood vessel wall dissection; the shape of the constraint ring 306 during the process of stretching and expanding and the shape after the final stretching and expansion are uniform, and the area and thickness of the part of the balloon 1 extending through each constraint ring 306 are roughly consistent during the whole process, and the pressure on the blood vessel is also roughly consistent, so that the blood vessel is always subjected to uniform force, achieving a good and uniform support effect on the blood vessel;

[0038] The balloon 1 is restricted by the constrained stent 3 and maintains an optimal expansion length and expansion diameter in the blood vessel. At the same time, the balloon 1 is also restricted and expands gently and evenly, avoiding too fast and excessive expansion of the blood vessel, reducing the radial force and axial force of the balloon 1 on the blood vessel wall, and the balloon 1 and the constrained stent 3 are not prone to rotation or displacement relative to the diseased blood vessel. The shear force on the blood vessel wall is uniform, and the entire treatment process is controllable and predictable, which greatly improves the treatment effect and reduces the probability of damage to the blood vessel and the occurrence of complications.

[0039] like Figures 1 to 6 As shown, one end of the return spring 4 is connected to the restraining member 2, and both ends of the restraining member 2 are welded to both ends of the balloon 1;

[0040] The two ends of the restraining member 2 are used to restrain the expansion of the two ends of the balloon 1, and a connecting arc plate 5, a first connecting piece 6 and a second connecting piece 7 form a group;

[0041] One side of the first connecting piece 6 is connected to the second connecting piece 7;

[0042] The above scheme is adopted: the constraint member 2 to the arc-shaped member 8 are all made of medical polymer materials, and the balloon 1, the constraint member 2, the constraint bracket 3, the reset spring 4, the second connecting piece 7 and other structures are provided. After the balloon 1 dredges the blocked blood vessel through the expansion of the constraint member 2 and the constraint bracket 3, the blood vessel remains unobstructed, and the balloon 1 is compressed. At the same time, the constraint member 2 retracts, and the constraint member 2 drives the connecting arc plate 5 to move through the reset spring 4, the first connecting piece 6 and the second connecting piece 7 retract, and the connecting arc plate 5 drives the main body 301 to retract through the arc-shaped member 8, so that when the balloon 1 is withdrawn along the blood vessel, the constraint member 2 and the constraint bracket 3 can be withdrawn together;

[0043] The balloon 1 mentioned in the present application is an interventional device that can expand and contract, and enters the natural lumen of the human body (such as blood vessels, esophagus, etc.) through a catheter for expansion treatment. According to the application site, the balloon 1 can be divided into a coronary artery balloon 1, a peripheral vascular balloon 1, an esophageal stenosis expansion balloon 1, etc. According to the material characteristics, the balloon 1 can be divided into a compliant, semi-compliant and non-compliant balloon 1. According to the design characteristics, it can be divided into a common balloon 1, a cutting balloon 1, a double guidewire balloon 1, a drug-coated balloon 1, etc.; the balloon 1 is mainly composed of an expandable balloon body and a connecting catheter. The balloon body part applies an expansion force to the lumen wall or the stent during the expansion process, and is the part that actually works in the operation. The connecting catheter is used to deliver the balloon 1 to the target position and expand the balloon 1 through pressurized liquid;

[0044] The balloon 1 temporarily expands the narrow lumen, improves blood flow or restores the normal function of the lumen mainly by physical expansion. In cardiovascular treatment, the balloon 1 can be used to treat vascular diseases such as arterial stenosis. The balloon 1 is delivered to the lesion through a catheter and pressurized to expand the balloon 1, thereby expanding the narrow blood vessel wall. In addition, the balloon 1 can also be used for the delivery and expansion of vascular stents, as well as the pre-expansion of blood vessels before vascular stent implantation and the precise shaping after implantation.

[0045] Compared with the restraint stent 3 in the present application which can be withdrawn together with the balloon 1, the currently commonly used restraint stent 3 can also be fixed on the blood vessel wall, and the restraint stent 3 is delivered to the diseased blood vessel site by utilizing the expansion force of the balloon 1, and the patency of the blood vessel is maintained by the supporting effect of the restraint stent 3. During the operation, the doctor first delivers the balloon 1 and the restraint stent 3 to the diseased blood vessel site through a catheter, and then applies pressure to expand the balloon 1, thereby expanding and fixing the restraint stent 3 on the blood vessel wall. The supporting effect of the restraint stent 3 can prevent blood vessel collapse and restenosis, thereby achieving the purpose of treating vascular diseases. The balloon restraint stent is an effective interventional device that can significantly improve the symptoms and prognosis of patients with cardiovascular diseases. Relevant matters need to be paid attention to when using it to ensure the success of the operation and the safety of the patient.

[0046] like Figures 1 to 6 As shown, the present invention also proposes a method for using a balloon restraint stent, comprising the following steps:

[0047] Step 1: The balloon 1, together with the restraint 2 and the restraint bracket 3, extends along the tube direction of the blood vessel. When reaching the position of the vascular lesion, the balloon 1 is expanded. While the balloon 1 is expanding, the restraint 2 restrains the balloon 1, and the expansion amplitude of the restraint 2 is the same as that of the balloon 1. The restraint 2 pushes the connecting arc plate 5 through the reset spring 4, so that the first connecting piece 6 and the second connecting piece 7 expand and extend. At the same time, the connecting arc plate 5 pushes the arc-shaped piece 8, and the arc-shaped piece 8 pushes the main body 301, so that the main body 301 expands.

[0048] Step 2: When the balloon 1 is expanded, the main body 301 can constrain the middle part of the balloon 1, and the connecting part 303 can effectively constrain the balloon 1 on both sides of the main body 301, so that after the balloon 1 is expanded, its outer surface can maintain a cylindrical shape as a whole, so that the blood vessel wall is subjected to uniform pressure, thereby effectively reducing the possibility of the "dog bone effect";

[0049] Step three, after the balloon 1 clears the blocked blood vessel through the expansion of the constraint 2 and the constraint stent 3, and the blood vessel remains unobstructed, the balloon 1 is compressed. At the same time, the constraint 2 retracts, and the constraint 2 drives the connecting arc plate 5 to move through the reset spring 4, the first connecting piece 6 and the second connecting piece 7 retract, and the connecting arc plate 5 drives the main body 301 to retract through the arc piece 8, so that when the balloon 1 is pulled out along the blood vessel, the constraint 2 and the constraint stent 3 can be pulled out together.

[0050] It should be noted that, in this article, 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 those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0051] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A balloon restraining stent, comprising a balloon (1), characterized in that: The outer wall of the balloon (1) is provided with a restraining member (2), the outer wall of the restraining member (2) is provided with a restraining bracket (3), the inner wall of the restraining bracket (3) is provided with arc-shaped members (8) in a circular shape and at equal angles, the inner side of each arc-shaped member (8) is provided with a connecting arc plate (5), one side of the connecting arc plate (5) is provided with a first connecting piece (6), the other side of the connecting arc plate (5) is provided with a second connecting piece (7), and the inner side of the connecting arc plate (5) is provided with a return spring (4).

2. The balloon restraint stent according to claim 1, characterized in that: The restraining bracket (3) comprises a main body (301), both sides of the main body (301) are provided with connecting wires (302), and one side of two groups of connecting wires (302) are provided with connecting parts (303).

3. The balloon restraint stent according to claim 2, characterized in that: One side of one group of the connecting parts (303) is provided with a proximal end portion (304), and one side of the other group of the connecting parts (303) is provided with a distal end portion (305). A plurality of restraint rings (306) are provided inside the main body (301).

4. The balloon restraint stent according to claim 3, characterized in that: Each group of the connecting parts (303) is provided in plurality, and the expansion amplitudes of the plurality of connecting parts (303) are consistent with the expansion amplitude of the main body (301).

5. The balloon restraining stent according to claim 3, characterized in that: The proximal portion (304) is used to restrict the expansion of both ends of the balloon (1).

6. The balloon restraining stent according to claim 3, characterized in that: The restraining ring (306) is a prismatic structure, and the restraining ring (306) is evenly and annularly or linearly distributed inside the main body (301).

7. The balloon restraining stent according to claim 1, characterized in that: One end of the return spring (4) is connected to the restraining member (2), and the two ends of the restraining member (2) are welded to the two ends of the balloon (1).

8. The balloon restraining stent according to claim 1, characterized in that: The two ends of the restraining member (2) are used to restrain the expansion of the two ends of the balloon (1), and one connecting arc plate (5), one first connecting piece (6) and one second connecting piece (7) form a group.

9. The balloon restraining stent according to claim 1, characterized in that: One side of the first connecting piece (6) is connected to the second connecting piece (7).

10. A method for using a balloon restraining stent, applied to the balloon restraining stent according to any one of claims 1 to 9, characterized in that: The steps include: Step 1: The balloon (1) together with the restraining member (2) and the restraining bracket (3) are extended along the tube direction of the blood vessel. When the balloon (1) reaches the position of the vascular lesion, the balloon (1) is expanded. While the balloon (1) is expanding, the restraining member (2) restrains the balloon (1), and the expansion amplitude of the restraining member (2) is the same as the expansion amplitude of the balloon (1). The restraining member (2) pushes the connecting arc plate (5) through the reset spring (4), so that the first connecting piece (6) and the second connecting piece (7) are expanded and extended. At the same time, the connecting arc plate (5) pushes the arc-shaped member (8), and the arc-shaped member (8) pushes the main body (301), so that the main body (301) is expanded. Step 2: When the balloon (1) is expanded, the main body (301) can constrain the middle part of the balloon (1), and the connecting part (303) can effectively constrain the balloon (1) on both sides of the main body (301), so that after the expansion of the balloon (1), its outer surface can maintain a cylindrical shape as a whole, so that the blood vessel wall is subjected to uniform pressure, thereby effectively reducing the possibility of the occurrence of the "dog bone effect"; Step three: After the balloon (1) clears the blocked blood vessel through the expansion of the constraint member (2) and the constraint bracket (3), and the blood vessel remains unobstructed, the balloon (1) is compressed. At the same time, the constraint member (2) retracts, and the constraint member (2) drives the connecting arc plate (5) to move through the reset spring (4), and the first connecting piece (6) and the second connecting piece (7) retract. The connecting arc plate (5) drives the main body (301) to retract through the arc member (8), so that when the balloon (1) is pulled out along the blood vessel, the constraint member (2) and the constraint bracket (3) can be pulled out together.

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