CN115554578B

CN115554578B - Restraint device for balloon, preparation method thereof and vasodilation instrument

Info

Publication number: CN115554578B
Application number: CN202211545279.2A
Authority: CN
Inventors: 关丽鹃; 王永刚
Original assignee: Suzhou Venmed Technology Co ltd
Current assignee: Suzhou Venmed Technology Co ltd
Priority date: 2022-12-05
Filing date: 2022-12-05
Publication date: 2023-04-28
Anticipated expiration: 2042-12-05
Also published as: CN115554578A

Abstract

The invention discloses a restraint device for a balloon, a preparation method thereof and a vasodilation instrument. The restraining device comprises an axial strip, a first connecting strip and a second connecting strip; the plurality of axial strips are arranged at intervals along the circumferential direction of the restraint device; the axial strip can elastically deform and is provided with a plurality of first connecting parts and a plurality of second connecting parts which are arranged at intervals along the length direction, and at least one second connecting part is arranged between two adjacent first connecting parts; the first connecting part of any one axial strip is connected with the first connecting part of one adjacent axial strip through the first connecting strip, and the second connecting part of any one axial strip is connected with the second connecting part of the other adjacent axial strip through the second connecting strip; each first connecting part is connected with only one first connecting strip, and each second connecting part is connected with only one second connecting strip. The restraint device has larger elastic deformation quantity, increases the specification range of the balloon which can be matched, and is suitable for dilating the plaque in the narrow blood vessel.

Description

Restraint device for balloon, preparation method thereof and vasodilation instrument

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a restraining device for a balloon, a preparation method thereof and a vasodilation instrument.

Background

Occlusion of the lumen of the human body is a common disorder, such as peripheral arterial disease (Peripheral Artery Disease, PAD), which is commonly referred to as various arterial lesions other than coronary arteries and intracranial arteries. One of the main methods for treating PAD is angioplasty, wherein the used apparatus is a balloon catheter, the vascular access is molded by performing angioplasty through the balloon catheter, or the balloon catheter is used for pre-expansion, post-expansion and the like when the vascular access is ensured by releasing the stent.

Balloon catheters generally include a balloon and a catheter for delivering and pressurizing the balloon. The size of the balloon may vary significantly with the inflation pressure. The size of the balloon is reduced by folding before the balloon reaches a lesion, the folded balloon can be unfolded in a rotary cutting mode in the pressurizing process after the balloon reaches the lesion, shearing force can be formed on the wall of a blood vessel to damage the wall of the blood vessel, the diameters of two ends of the balloon can be larger than those of plaque areas in the blood vessel with plaque, namely a dog bone effect, and the phenomenon can cause damage to the blood vessel. The common balloon has a phenomenon that the balloon slips off when the blood vessel with plaque is dilated due to smooth appearance, which reduces the dilation effect of the balloon.

In order to solve the above problems, there is proposed a proposal to provide a constraining structure on a conventional balloon catheter in order to reduce damage to the vessel wall and to avoid balloon slipping. This solution is very demanding for the design of the constraint structure, including at least: firstly, the constraint structure is required to expand compliantly with the inflation of the balloon, and the risk of fracture or breakage is very small in the expansion process and the process of acting after expansion; secondly, considering that the same size balloon in the industry usually has a tolerance of up to + -10% due to uncontrollable factors of equipment and manufacturing processes, the constraint structure matched with the balloon has to have good balloon adaptability to ensure good consistency of the product as a whole in use, thereby being beneficial to improving operation accuracy and reducing damage to the vessel wall. However, the prior art restraint structure has not yet met the aforementioned requirements.

Disclosure of Invention

The invention aims to solve the technical problem of overcoming the defects of the prior art and providing a novel restraining device for a balloon and a preparation method thereof. The invention also provides a vessel dilating instrument adopting the novel restraining device for the saccule.

A first aspect of the present invention provides a constraining device for a balloon having an inner space accommodating the balloon, the constraining device having an expanded state capable of expanding with the balloon and a contracted state contracted with the balloon, the constraining device including a plurality of axial strips, a plurality of first connecting strips, and a plurality of second connecting strips;

the plurality of axial strips are arranged at intervals along the circumferential direction of the restraint device; each axial strip can elastically deform and is provided with a plurality of first connecting parts and a plurality of second connecting parts which are arranged at intervals along the length direction, and at least one second connecting part is arranged between two adjacent first connecting parts;

the first connecting part of any one axial strip is connected with the first connecting part of one adjacent axial strip through the first connecting strip, and the second connecting part of any one axial strip is connected with the second connecting part of the other adjacent axial strip through the second connecting strip;

each first connecting part is connected with only one first connecting strip, and each second connecting part is connected with only one second connecting strip;

two adjacent axial strips and two adjacent first connecting strips or two adjacent second connecting strips between the two axial strips enclose an expansion outlet for the balloon to expand outwards; when the restraint device is in a contracted state, the axial strip extends along the length direction of the restraint device for the balloon; when the restraint device is in the expansion state, the axial strip is bent at the first connecting part and the second connecting part, and the outline shape of the expansion opening is a polygon with the side number being more than or equal to 6.

Preferably, the plurality of first connecting strips and the plurality of second connecting strips are staggered, one second connecting portion is arranged between two adjacent first connecting portions, and one first connecting portion is arranged between two adjacent second connecting portions.

Preferably, the axial strip, the first connecting strip and the second connecting strip are integrally arranged, and the axial strip and the first connecting strip or the second connecting strip are in arc transition.

More preferably, the first connection part has a transition angle protruding to a side where the first connection bar is located, the first connection bar being connected to the transition angle; the second connecting part is provided with a transition angle protruding towards one side where the second connecting strip is located, and the second connecting strip is connected with the transition angle.

Further, the widths of the first and second connection portions are the sum of the width of the portion of the axial strip between the first and second connection portions and the chamfer radius of the transition angle.

Preferably, the axial strip extends linearly along the length of the balloon restriction device when the restriction device is in the contracted state.

More preferably, when the restriction device is in the inflated state, any one of the inflation openings has a hexagonal shape, wherein one of the axial strips forms two sides of the hexagon, the other axial strip forms the other two sides of the hexagon, and the two first or second connection strips form the remaining two sides.

More preferably, the lengths of the first connection bars, the lengths of the second connection bars, and the pitches of the adjacent first connection portions and second connection portions are equal.

Preferably, when the restraint device is in the inflated state, the first connecting strip and the second connecting strip are perpendicular to the length direction of the restraint device for the balloon.

Preferably, the first and second connecting strips comprise one or more arcuate portions when the restraining means is in the contracted state.

More preferably, the shape of the first and second connection bars is sinusoidal when the restraining means is in the contracted state.

Preferably, the first and second connection bars have elasticity.

Preferably, the constraining device further comprises a proximal connecting stent and a distal connecting stent for connecting the balloon catheter, a proximal end portion of a part of the axial strips being connected between the proximal connections, and a distal end portion of the other axial strips being connected to the distal connecting stent.

Preferably, the restraining device is integrally formed by nickel-titanium alloy, and the axial strip, the first connecting strip and the second connecting strip are nickel-titanium alloy wires respectively.

Preferably, when the restraint device is in the expansion state, the outline shape of the expansion opening is a polygon with 6-10 sides.

The second aspect of the present invention provides a method for preparing the restraining device for a balloon, comprising the steps of: providing a nickel-titanium alloy tube with a thin wall, cutting the nickel-titanium alloy tube, and forming an axial strip, and connecting the axial strip with a first connecting strip and a second connecting strip connected with the axial strip.

The third aspect of the invention provides a vasodilation apparatus, comprising a balloon and a catheter for pushing the balloon, wherein the balloon apparatus further comprises a restraining device for the balloon, the restraining device for the balloon is fixedly connected with the catheter, the balloon is arranged in the restraining device, the restraining device is in an expanded state after the balloon is expanded, a plurality of pillows which are outwards protruded and are arranged in a staggered way are formed by expanding a plurality of balloon walls of the balloon from the expansion outlet, and a concave part is arranged between the adjacent pillows.

Preferably, the surface of the balloon and/or the surface of the restriction device is loaded with a medicament. More preferably, the agent is one or more of an agent that inhibits proliferation of intimal smooth muscle cells and/or an agent that eliminates inflammation. Specifically, the drug is paclitaxel which inhibits proliferation of intimal smooth muscle cells.

Compared with the prior art, the invention has the following advantages:

according to the restraining device for the balloon, through the integral structural design, particularly, the first connecting parts and the second connecting parts of the axial strips are arranged in a staggered mode, and each connecting part is connected with only one first connecting strip or one second connecting strip, on one hand, the restraining device for the balloon has proper elastic deformation on the whole, the specification range of the balloon which can be adapted is wider, and the consistency of the balloon in use of products is ensured; on the other hand, the structural design has more uniform stress distribution, and compared with the structure in the prior art, the structural design has the advantages of remarkably reduced fracture risk and better safety.

The blood vessel dilating device has the advantages that the constraining device for the saccule has small fracture risk and good safety when being used for dilating the blood vessel stenosis, can effectively reduce the damage of the saccule to the blood vessel wall, and ensures that the saccule is not easy to slip. For doctors, the uniformity of the vasodilator is good, so that the vasodilator can be more accurately implemented, and the damage to blood vessels is reduced to the maximum extent. The control requirements for balloon tolerances are reduced for the manufacturer, so that production costs can be reduced.

Drawings

In order to more clearly illustrate the technical solutions of the present invention, the drawings that are needed in the description of the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a configuration of a vasodilator device according to an embodiment of the present invention, wherein the balloon is unexpanded and the constraining scaffold is in a contracted state;

FIG. 2 is a schematic view of a configuration of a vasodilator device according to an embodiment of the present invention, wherein the balloon is inflated and the constraining scaffold is in an inflated state;

fig. 3 is a schematic view of a restraint device according to an embodiment of the present invention in a collapsed state.

Fig. 4 is an enlarged partial schematic view of the restriction device in a contracted state.

Fig. 5 is a schematic view of a restraint device according to an embodiment of the present invention in an expanded state.

Fig. 6a is a schematic representation of a variation of an axial strip according to an embodiment of the present invention.

FIG. 6b is a force analysis diagram of an axial strip according to an embodiment of the present invention.

Detailed Description

Preferred embodiments of the present invention will be described in detail below with reference to the attached drawings so that the advantages and features of the present invention can be more easily understood by those skilled in the art. The description of these embodiments is provided to assist understanding of the present invention, but is not intended to limit the present invention. In addition, technical features of the embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.

The embodiment provides a restraint device for a balloon and a vasodilation instrument with the restraint device. Referring to fig. 1 and 2, the vasodilator with this restriction device 1 further comprises a balloon 2 and a catheter 3 for pushing the balloon 2 to the site to be treated of the blood vessel. The balloon 2 can be inflated and contracted, and after a certain amount of gas or liquid is introduced into the balloon 2 through the catheter 3, the balloon 2 is inflated; the restraint device 1 is sleeved outside the balloon 2, and the surface of the balloon 2 and/or the surface of the restraint device 1 can be loaded with medicines; the restriction device 1 is fixedly connected to the catheter 3. The restraint device 1 can also assist the retraction of the balloon 2 under the condition of pressure relief, and the diameter of the inflated restraint device 1 is smaller than the diameter of the balloon 2 in the unconstrained state, so that the over-inflation of the balloon 2 can be limited, and the restraint device 1 can be withdrawn from the body along with the catheter 3 of the balloon 2 after the end of the blood vessel expansion, and cannot be left in the body.

As shown in connection with fig. 1 to 5, the restriction device 1 has an inner space in which the balloon 2 is accommodated, the balloon 2 being located in the inner space. The restriction device 1 has an inflated state, in which it is inflatable with the balloon 2, and a deflated state, in which it is deflatable with the balloon 2. Specifically, the body portion of the restraint device 1 is sleeved on the balloon 2, and includes a plurality of axial strips 11 (e.g., 6), a plurality of first connecting strips 12, and a plurality of second connecting strips 13. The plurality of axial strips 11 are arranged at intervals along the circumferential direction of the restraining means, and in this embodiment, the plurality of axial strips 11 are equally spaced along the circumferential direction of the restraining means. Each axial bar 11 is elastically deformable, and has a plurality of first connecting portions 111 and a plurality of second connecting portions 112 that are provided at intervals along the longitudinal direction of the restraining device. The first connecting portions 111 and the second connecting portions 112 are alternately distributed, and at least one second connecting portion 112 is arranged between two adjacent first connecting portions 111. The first connecting portion 111 of any one axial bar 11 and the first connecting portion 111 of one axial bar 11 adjacent thereto are connected by the first connecting bar 12, and the second connecting portion 112 of any one axial bar 11 and the second connecting portion 112 of the other axial bar 11 adjacent thereto are connected by the second connecting bar 13.

The connection will be described in detail by taking the specific axial bar 11b in fig. 3 and 5 as an example. The axial bar 11b is connected with the axial bar 11a on the left side thereof by a plurality of first connecting bars 12, and the first connecting bars 12 are specifically connected with the first connecting portions 111 of the axial bars 11 b; the axial bar 11b is connected to the axial bar 11c on the right side thereof by a plurality of second connecting bars 13, and the second connecting bars 13 are specifically connected to the second connecting portions 112 of the axial bar 11 b. It should be further noted that each first connecting portion 111 is connected to only one first connecting bar 12, and each second connecting portion 112 is connected to only one second connecting bar 13.

Two adjacent axial strips 11 and two adjacent first connecting strips 12 or two adjacent second connecting strips 13 between the two adjacent axial strips enclose an expansion opening 10 for the balloon 2 to expand outwards, and when the restraint device 1 is in an expansion state, the expansion opening 10 is in a polygonal shape with the number of sides being more than or equal to 6. The number of sides satisfies the following condition: 2N, N is a positive integer greater than or equal to 3; further, the number of sides is 6 or more and 10 or less. In this embodiment, the first connecting strips 12 and the second connecting strips 13 are staggered, and a second connecting portion 112 is disposed between two adjacent first connecting portions 111, and a first connecting portion 111 is disposed between two adjacent second connecting portions 112; thus, when the restriction device 1 is in the inflated state, the shape of the inflation port 10 is a hexagon, wherein one of the axial strips 11 forms two sides of the hexagon, the other axial strip 11 forms the other two sides of the hexagon, and the two first connection strips 12 or the two second connection strips 13 form the remaining two sides. For example, referring to fig. 4, the axial bars 11a form two sides of the hexagonal expansion port 10, the axial bars 11b form the other two sides of the hexagonal expansion port 10, and the two first connection bars 12 form the remaining two sides of the hexagonal expansion port 10. Further, the first connecting portion 111 and the second connecting portion 112 on the same axial bar 11 are disposed at equal intervals, the shape of the expansion port 10 is regular hexagon when the restraint device 1 is in the expanded state, and the length of the first connecting bar 12, the length of the second connecting bar 13, and the distance between the adjacent first connecting portion 111 and second connecting portion 112 are equal.

The axial strip 11, the first connecting strip 12 and the second connecting strip 13 are integrally arranged, and an arc transition is formed between the axial strip 11 and the first connecting strip 12 or the second connecting strip 13, as shown in fig. 3. The first connection portion 111 has a transition angle protruding toward a side where the first connection bar 12 is located, and the first connection bar 12 is connected to the transition angle; the second connection portion 112 has a transition angle protruding toward a side where the second connection bar 13 is located, and the second connection bar 13 is connected to the transition angle. The width of the first and

second connection portions

111 and 112 is the sum of the width of the portion of the axial strip 11 located between the first and second connection portions and the chamfer radius of the transition angle. In this embodiment, the width of the axial bar 11 is 50% greater than the widths of the first connecting bar 12 and the second connecting bar 13.

The axial strip 11 has elasticity, and can be elastically bent and deformed, and when the balloon 2 is inflated, the first connecting part 111 of the axial strip 11 receives a pulling force from the first connecting strip 12 to one side, so that the axial strip is bent to one side; the second connection portion 112 receives a pulling force from the second connection bar 13 to the other side, thereby being bent to the other side. When the restriction device 1 is in the contracted state, the axial strips 11 extend straight along the length direction (axial direction) of the restriction device 1 along the balloon 2. When the restraint device 1 is in the expanded state, the axial strip 11 is bent at each of the first connecting portion 111 and the second connecting portion 112 to form a fold line shape. Further, the axial strips 11 can also elastically stretch and deform, and when the stress is large, the axial strips 11 are stretched.

The first 12 and second 13 connecting strips comprise one or more arcuate portions when the restriction device 1 is in the contracted state. Further, the shapes of the first connecting bar 12 and the second connecting bar 13 are sine waves, that is, are formed by combining a plurality of circular arc portions. When the restraint device 1 is in the inflated state, the first connecting strip 12 and the second connecting strip 13 are perpendicular to the axial direction of the restraint device 1 for the balloon 2. The first connecting bar 12 and the second connecting bar 13 have elasticity and can be bent and deformed, and can also be deformed in a telescopic manner.

The restraining device 1 further comprises a proximal connecting stent 14 and a distal connecting stent 15 for connecting the catheter 3, wherein the proximal end of some of the axial strips 11 are connected to the proximal connecting stent 14 and the distal end of other axial strips 11 are connected to the distal connecting stent 15. The proximal and distal connecting

stents

14, 15 are secured to the catheter 3 by heat staking or adhesive means. Herein, "proximal" and "distal" are defined in terms of the state of the medical personnel when operating the vasodilator device, and are defined as the proximal end at a distance closer to the hand of the medical personnel operating the device, and the distal end at a distance farther.

The restraint device 1 is integrally formed by nickel-titanium alloy, and the axial strip 11, the first connecting strip 12 and the second connecting strip 13 are respectively nickel-titanium alloy wires formed by cutting.

The preparation method of the restraint device 1 for the balloon 2 comprises the following steps: a nickel-titanium alloy tube with a thin wall is provided, and the nickel-titanium alloy tube is cut to form an axial bar 11, a first connecting bar 12 connected with the axial bar 11, and a second connecting bar 13 connected with the axial bar 11. The proximal connecting bracket 14 and the distal connecting bracket 15 are also nickel-titanium alloy wires formed by cutting the nickel-titanium alloy tube.

As shown in fig. 2, in the above-mentioned vasodilator, the restraint device 1 is in an inflated state after the balloon 2 is inflated, and a plurality of pillows 21 are inflated from the inflation outlet 10 to form a plurality of outwards protruding and staggered pillows 21, and a concave portion 22 is provided between the adjacent pillows 21. The plurality of convex pillows 21 are in contact with the blood vessel wall and function to expand the blood vessel. As shown in fig. 1, after the balloon 2 is depressurized, the pillow 21 disappears, and the restraint device 1 is retracted, contracted together with the balloon 2, out of contact with the vessel wall, and withdrawn outside the body with the balloon 2. Taking an axial strip 11 of width 0.08mm as an example, the inflated inner diameter of the restriction device 1 at nominal pressure is 0.13mm-0.23mm smaller than the inner diameter of the adapted balloon 2.

The vasodilator may further comprise a tip tube attached to the distal end of the catheter 3 and a visualization ring. The catheter 3 comprises an inner tube and an outer tube which are sleeved with each other, and a developing ring is arranged on the inner tube to indicate the position of the balloon 2. The proximal and distal connecting

brackets

14, 15 of the restriction device 1 are fixed to the outer tube.

The surface of the balloon 2 and/or the surface of the restriction device 1 is loaded with a medicament. The medicine is one or more of medicine for inhibiting proliferation of medium membrane smooth muscle cells and/or medicine for eliminating inflammation. Specifically, the drug is paclitaxel which inhibits proliferation of intimal smooth muscle cells.

The structure restraining device and the vasodilation apparatus have the following advantages:

1. the first connecting part 111/second connecting part 112 of the axial strip 11 only needs to be connected with the first connecting strip 12/second connecting strip 13 at one side, the width of the connecting part of the axial strip 11 and the connecting strip is controlled (the maximum width is reduced by 15-40% compared with other possible structures), so that the whole restraint device has larger deformation, stress concentration is reduced, and the product fracture risk is small.

For example: the width of the main portion of the connecting strip (except the first connecting portion 111/second connecting portion 112) is 0.15mm, the transition angle is rounded at the first connecting portion 111/second connecting portion 112, the chamfer radius is 0.08mm, and the maximum width of the axial strip 11 is 0.23mm. If the following structure is adopted: the connecting strips are connected to two sides of the same connecting portion of the axial strip, and then the two sides of the connecting portion of the axial strip are chamfered, so that the maximum width of the axial strip is 0.31mm, and compared with the maximum width of the axial strip 11 in the structure of the embodiment is reduced by 25%.

The reduction of the width at the connection portion can increase the linear elastic quantity in the radial direction of the whole restraining device 1. If the diameter of the restraint device 1 after expansion is 6mm, the perimeter of the restraint device 1 is 6pi, wherein there are 6 axial strips 11, and there are three groups of first connecting strips 12 and three groups of second connecting strips 13 seen from the circumferential direction, so there are 6 groups of joints, the total width (6×0.23 mm) of the joints accounts for 7.3% of the perimeter of the restraint device 1, and compared with 9.8% of the conventional structure (the total width of the joints is 6×0.31 mm), the overall deformation amount of the restraint device 1 in this embodiment is larger. Assuming that the elastic deformation of nickel titanium is 7%, the deformation amount of the restraint device 1 in this embodiment is closer to 7% than that of a connecting mechanism that two sides of the same connecting portion of the axial strip are connected with connecting strips, the occupation ratio of the rod width at the connecting portion is reduced, and the elastic deformation of the instrument can be increased.

2. The axial strips 11 can adapt to the size of the balloon 2 to generate corresponding deformation so as to compensate the problem of poor pillow expansion effect caused by the tolerance of the balloon 2, namely, the size range of the balloon 2 which can be adapted is enlarged, the method is suitable for industrialized production, and the assembly cost of the vasodilation apparatus is reduced.

Referring to fig. 6a, the restraining device 1 of the present embodiment may generate different amounts of deformation according to the size of the balloon 2. The axial strip 11 is subjected to an upward pulling force from the first connecting strip 12 and to a downward pulling force from the second connecting strip 13. When the balloon 2 is contracted, the axial strips 11 remain horizontal, as shown in the position P1 in fig. 6 a. When the balloon 2 begins to expand, the first and second connection strips 12 and 13 are deployed and gradually straightened; referring to fig. 6b, at this time, the tensile force F1 of the first connecting bar 12 increases, the direction of the component force F2 of the tensile force from the second connecting bar 13 is inclined downward, and the axial bar 11 is bent and deformed, so that the three components form a mechanical balance. When the diameter of the balloon 2 is larger, F1 is larger, so that the connecting rod is deformed more, and the corresponding F2 is increased to achieve mechanical balance. Referring to fig. 6a, P2 is a position where the small diameter balloon 2 is fitted and the axial strips 11 are deformed after the balloon 2 is inflated; p3 is a position where the large diameter balloon 2 is fitted and the axial strips 11 are deformed after the balloon 2 is inflated. Therefore, the structural design can solve the problem that the inflated pillow part is not obvious due to the dimensional tolerance of the balloon 2, so that the balloon 2 with a large specification range can be adapted, and the consistency of the use of products is ensured.

3. When the restraint device 1 is in the inflated state, the distance between pillows formed by the inflation of the saccule 2 is smaller, more pillows exist in unit length, and vascular plaques are easy to dilate, so that the restraint device is suitable for being applied to narrow blood vessels.

The embodiment adopts a staggered arrangement, and the smaller the interval between the highest points of the adjacent pillows is, the more beneficial to dilating the narrow blood vessel.

As used in this specification and in the claims, the terms "comprises" and "comprising" merely indicate that the steps and elements are explicitly identified, and do not constitute an exclusive list, as other steps or elements may be included in a method or apparatus. The term "and/or" as used herein includes any combination of one or more of the associated listed items.

It should be noted that, unless otherwise specified, when a feature is referred to as being "fixed" or "connected" to another feature, it may be directly or indirectly fixed or connected to the other feature. Further, the descriptions of the upper, lower, left, right, etc. used in the present invention are merely with respect to the mutual positional relationship of the constituent elements of the present invention in the drawings.

The above-described embodiments are provided for illustrating the technical concept and features of the present invention, and are intended to be preferred embodiments for those skilled in the art to understand the present invention and implement the same according to the present invention, not to limit the scope of the present invention. All equivalent changes or modifications made according to the principles of the present invention should be construed to be included within the scope of the present invention.

Claims

1. A constraining device for a balloon having an interior space accommodating a balloon, the constraining device having an inflated state capable of inflating with the balloon and a deflated state deflating with the balloon, the constraining device comprising a plurality of axial strips, a plurality of first connecting strips, and a plurality of second connecting strips;

2. The balloon restraint device of claim 1, wherein the plurality of first connection bars and the plurality of second connection bars are staggered, one second connection portion is provided between two adjacent first connection portions, and one first connection portion is provided between two adjacent second connection portions.

3. The constraining apparatus according to claim 1 or 2, wherein the axial strip is integrally provided with the first connecting strip and the second connecting strip, and the axial strip and the first connecting strip or the second connecting strip are in circular arc transition.

4. A balloon restraint device according to claim 3, wherein the first connection portion has a transition angle protruding to a side where the first connection bar is located, the first connection bar being connected to the transition angle; the second connecting part is provided with a transition angle protruding towards one side where the second connecting strip is located, and the second connecting strip is connected with the transition angle.

5. The balloon restraint device of claim 4 wherein the first and second connection portions have a width that is the sum of the width of the portion of the axial strip between the first and second connection portions and the chamfer radius of the transition angle.

6. The balloon restraint device according to claim 1 or 2, wherein the axial strip extends straight along a length direction of the balloon restraint device when the restraint device is in a contracted state.

7. The balloon restriction device according to claim 6, wherein in the inflated state of the restriction device, any one of the inflation ports has a hexagonal shape, wherein one of the axial strips forms two sides of the hexagon, the other axial strip forms the other two sides of the hexagon, and the two first connection strips or the two second connection strips form the remaining two sides.

8. The constraining apparatus according to claim 1 or 7, wherein the length of the first connecting bar, the length of the second connecting bar, and the pitch of the adjacent first connecting portion and second connecting portion are equal.

9. The balloon restraint device of claim 1, wherein the first and second connection bars are perpendicular to a length direction of the balloon restraint device when the restraint device is in the inflated state.

10. The balloon restraint device of claim 1 wherein the first and second connection strips include one or more arcuate portions when the restraint device is in a contracted state.

11. The balloon restraint device of claim 10 wherein the first and second connection strips are sinusoidal in shape when the restraint device is in a contracted state.

12. The balloon restraint device of claim 1, wherein the first and second attachment strips are resilient.

13. The balloon restraint device of claim 1 further comprising a proximal connection bracket and a distal connection bracket for connecting to a balloon catheter, wherein a proximal portion of a portion of the axial strips are connected to the proximal connection bracket and a distal portion of the other axial strips are connected to the distal connection bracket.

14. The balloon restraint device of claim 1, wherein the restraint device is integrally formed of a nitinol, and the axial strips, the first connecting strips, and the second connecting strips are each nitinol wires.

15. The restriction device for a balloon according to claim 1, wherein the outline shape of the inflation port is a polygon having 6 to 10 sides when the restriction device is in the inflated state.

16. A method of preparing a restriction device for a balloon according to any one of claims 1 to 15, comprising the steps of: providing a nickel-titanium alloy pipe with a thin wall, cutting the nickel-titanium alloy pipe to form an axial strip, a first connecting strip connected with the axial strip and a second connecting strip connected with the axial strip.

17. A vessel dilation instrument comprising a balloon and a catheter for pushing the balloon, wherein the vessel dilation instrument further comprises a constraint device for the balloon according to any one of claims 1 to 15, the constraint device for the balloon is fixedly connected to the catheter, the balloon is arranged in the constraint device, the constraint device is in an expanded state after the balloon is expanded, a plurality of pillows which are outwards protruded and are arranged in a staggered mode are formed by expanding a plurality of balloon walls of the balloon from expansion outlets, and a concave part is arranged between every two adjacent pillows.

18. A vasodilator device according to claim 17, wherein the surface of the balloon and/or the surface of the constraining means is loaded with a medicament.