WO2019084951A1

WO2019084951A1 - High-strength restraint stent of non-implantable balloon catheter and blood vessel expanding device using same

Info

Publication number: WO2019084951A1
Application number: PCT/CN2017/109501
Authority: WO
Inventors: 陈丽君; 季培红; 王成
Original assignee: 杭州巴泰医疗器械有限公司
Priority date: 2017-11-06
Filing date: 2017-11-06
Publication date: 2019-05-09

Abstract

Disclosed is a high-strength restraint stent of non-implantable balloon catheter, comprising a main body part (1) for encapsulating the outer part of said balloon catheter, and a fixing part (2) connected to the two ends of said main body part and designed for fixing said connecting balloon catheter, wherein said restraint stent is used for tracking said balloon catheter expansion, or contracting and inhibiting the maximum expanded volume of said balloon catheter. Also disclosed is a non-implantable blood vessel expanding device, comprising said balloon catheter, and said restraint stent having respectively a compression shape for the implantable blood vessel and an expanded shape used for blocking blood vessels. The maximum diameter of said restraint stent in the expanded shape is smaller than the maximum diameter of said balloon catheter in an expanded shape. The invention is simple in structure, convenient to use, greatly improves the treatment efficiency, and reduces the occurrence probability of damage and blood vessel complications.

Description

Technical field

[0001] The present invention relates to the field of angioplasty surgical instruments, and in particular to a high-strength restraint stent for a non-implantable balloon catheter and a blood vessel expansion device using the same.

Background technique

[0002] For cardiovascular disease, balloon angioplasty is one of the most commonly used treatments. The conventional balloon catheter is made into an inflated and cylindrical balloon of different diameters and lengths according to the size of the patient's blood vessel and the length of the lesion. The working principle is as follows: Using a delivery system, a balloon dilatation catheter is placed on the catheter. At the lesion, after the balloon is inflated, the blood vessels are expanded to expand the lumen.

[0003] Traditional balloon angioplasty is often accompanied by vascular damage, such as the proximal end of the balloon during balloon dilation, and the distal diameter is larger than the central diameter of the balloon, ie, the "dog bone effect", resulting in both ends of the balloon. Excessive expansion of the contact vessel, causing damage to the vessel wall and causing longitudinal elongation of the balloon to accelerate the vascular dissection (>30%), can cause acute vascular occlusion of the lesion (5%~12%) and postoperative restenosis (50 %).

[0004] Because of the numerous vascular injuries in conventional balloon angioplasty, it is often used as an initial treatment for cardiovascular disease, and a bare stent or drug stent is often implanted after initial treatment. Although bare metal stents and drug stents have been shown to have better patency rates after balloon angioplasty, there are still long-term adverse clinical outcomes and advanced restenosis, especially for lower extremity arteries. May cause stent fracture or restenosis in the stent.

[0005] Vascular dissection, acute vascular occlusion, and vascular wall injury are all severe vascular traumas, and the formation of such trauma is closely related to the mechanism of action of angioplasty using conventional balloons.

[0006] Conventional balloon catheter mechanism includes the shearing force applied by the folded balloon to the vessel wall during inflation; due to the limitations of the structure and material of the conventional balloon, and the morphological differences of the vascular lesion, The characteristics of the opposite sex lead to the inevitable "dog bone effect" of the balloon during use, causing further trauma of the blood vessel and vascular damage in the non-lesional area.

[0007] A balloon catheter is disclosed in the patent document No. CN105963848A, which has: a balloon; a side tube connected to a base end of the balloon; an inner tube disposed inside the outer tube; a distal end of the inner tube connected to a distal end of the balloon; an uneven portion formed on an outer circumference of the inner tube; The core wire is disposed between the outer tube and the inner tube, wherein the core wire includes a bulging portion that is sandwiched between the outer tube and the concave portion of the uneven portion, and the softness of the balloon catheter can be ensured Good transmission of sex and push-pull force, but the aforementioned problems still exist.

technical problem

Problem solution

Technical solution

[0008] One of the technical objects of the present invention is to provide a high-intensity restraint bracket of a non-implantable balloon catheter, which has a high structural strength, can allow and follow the balloon catheter to expand or contract, and simultaneously suppress the ball. The balloon catheter is fully or over-expanded, that is, the balloon catheter is optimally expanded according to the expansion mode of the restraining stent, and the vascular injury is minimized in the same state of ensuring vasodilation.

[0009] A specific technical solution of the present invention is as follows: A high-intensity restraint stent of a non-implantable balloon catheter, comprising a tubular body structure for covering a body portion outside the balloon catheter and connecting to the body portion a fixing portion at both ends for fixedly connecting the balloon catheter, the constraining bracket for expanding or contracting following the balloon catheter and suppressing a maximum expansion volume of the balloon catheter; the body portion including a plurality of memory grid units and located at the a spacing unit between the memory grid units, the memory grid units being arrayed along the length direction of the body portion and being arrayed along the circumference of the body portion, adjacent to the memory grid unit Connected by the memory connection key.

[0010] the restraining stent encloses the entire balloon catheter and is fixedly connected at the proximal end and the distal end of the balloon catheter

The restraining bracket itself is not easily detached from the balloon catheter and is inserted or withdrawn along with the balloon catheter. The restraining bracket has an initial collapsed state and abuts against the surface of the balloon portion such that the diameter of the balloon portion is as small as possible in the collapsed state. The restraining bracket slowly expands as the balloon portion is inflated, and the balloon portion is uniformly and gently expanded by the restraining bracket, and the balloon portion does not instantaneously expand due to its own characteristics or expands into a non-lesional region with less resistance. , causing damage to the vessel wall or non-lesional area. After the balloon is inflated or released, the restraining bracket can effectively control the length, diameter and expansion rate of the balloon, reduce or eliminate the axial force and radial force of the balloon to the blood vessel, and disperse the balloon to the blood vessel. Three-dimensional shear force increases the controllability and predictability of the vascular treatment process, and is excellent for long-path lesions (100~300mm) treatment effect. The memory grid unit and the spacing unit allow the balloon to continue to pass through the restraint expansion of the restraining bracket to generate a protrusion that contacts the blood vessel wall, and the necessary uniform expansion of the blood vessel wall is also beneficial for loading Post-medication touch. Although the direct connection of the memory grid unit can ensure good memory and molding degree, it is easy to generate a multi-directional stress during twisting during use, causing a connection break between the memory grid units, and a memory connection key. The setting can ensure the memory and the degree of molding, eliminate the stress during use, and ensure the stability and strength of the structure.

[0011] Preferably, each of the memory grid units is provided with two first connection points and two second connection points, and the length of the main body portion is adjacent to the memory grid unit The respective first connection points and a memory connection key are connected, and the memory grid units adjacent to each other in the circumferential direction of the main body portion are connected by the respective second connection points and a memory connection key.

[0012] The memory grid units are connected by the first connection point, the second connection point, and the memory connection key, and are structurally simplified and stable as possible, have good consistency, and are not easily broken. And facilitating the expansion of the memory grid unit or the constraining bracket, and ensuring that the generation of the spacing unit and the space ratio thereof are as large as possible, which is advantageous for the balloon catheter to expand and pass through the memory grid unit. The spacer unit forms a plurality of convex arrays and corresponding concave arrays, and the convex array is softly and uniformly contacted with the blood vessel wall, and the lesion is more easily snorted, and the array of the same depression provides space for the flow of platelets, which ensures Circulation, allowing platelet remodeling, promoting wound healing, minimizing or preventing restenosis, and eliminating the risk of late thrombosis.

[0013] Advantageously, the interval between the two first connection points of each of the memory grid units is a maximum length direction of the memory grid unit, each of the memory grids a gauge between two of the second connection points of the unit is a maximum circumferential direction of the memory grid unit; the maximum length direction spacer is always constant such that the body portion is in a length room direction The expansion and contraction does not occur, and the maximum circumferential direction interval changes or expands in accordance with the expansion or contraction of the memory grid unit to cause the main body portion to expand or contract in the radial direction.

[0014] Such an arrangement defines the expansion size of the memory grid unit, that is, the constraining bracket actually has no substantial change in the length of the stent due to the expansion characteristic of the memory grid unit or only occurs very slightly. The value varies, and the diameter of the stent is variable and there is a value for suppressing the maximum expansion diameter of the balloon catheter, that is, when the pressure inside the balloon is further increased, the balloon catheter does not elongate or has a slight axial elongation. The presence of the memory grid unit and the spacer unit makes the balloon catheter more difficult to stretch due to the resistance generated after the passage, and the balloon catheter is only allowed to reach a limited, predetermined expansion due to the limitation of the stent diameter. Diameter, the balloon compliance value in this case is significantly higher than the traditional balloon, effectively avoiding the "dog bone effect". The inflation of the balloon catheter is predictable and effectively controlled, thus greatly reducing the non-lesional area. The damage may be, avoid the formation of vascular dissection, and reduce the rate of restenosis of the blood vessels. In addition, if the memory grid unit is designed to be smaller, the nominal pressure and burst pressure of the balloon are higher.

[0015] Preferably, the length of the memory connecting key 13 disposed along the longitudinal direction of the main body portion 1 and the length of the side portion constituting the mesh unit 11 are 1:20 to 30, along the The length of the memory connecting key 13 provided in the circumferential direction of the main body portion 1 and the length of the side portion constituting the mesh unit 11 are 1:80 to 100.

[0016] Preferably, the diameter of the memory connection key 13 is the same as the diameter of the side section constituting the mesh unit 11.

[0017] Preferably, the memory grid unit is composed of a plurality of side segments, each of the side segments not coincident with the longitudinal direction of the blood vessel and the circumferential direction of the blood vessel to cause the restraining bracket to expand or contract. No circumferential or axial offset of the opposing vessel wall occurs.

[0018] The design is such that the memory grid unit expands or contracts, and each of the side segments does not elongate or shorten along the length direction and the circumferential direction of the blood vessel, that is, during the change process. The segments will always be displaced in the length direction and circumferential direction of the blood vessel and produce a uniformly dispersed shear force, which will easily smash the lesion, reduce damage to the vessel wall, and will not cause the entire restraint bracket. A circumferential rotation or axial offset occurs.

[0019] Preferably, the memory grid unit has a diamond shape. The diamond-shaped mesh can perfectly conform to the aforementioned design conditions, and the two diagonal lines respectively coincide with the longitudinal direction and the circumferential direction of the blood vessel, and the two vertices along the circumferential direction of the blood vessel, that is, the second connection point, along The two vertices in the longitudinal direction of the blood vessel, that is, the first connection point, each of which does not coincide with the longitudinal direction and the circumferential direction of the blood vessel, and is accurately and stably expanded together with the balloon catheter at the lesion site. The structure is low in complexity, and the process is simple to manufacture and easy to implement.

[0020] Preferably, the fixing portion includes a memory connecting segment connected to both ends of the main body portion and a welded portion connected to the memory connecting portion. In actual use, the memory is better, and it is not easy to rotate or shift the restraint bracket.

[0021] Preferably, the memory connecting segments are staggered at two ends of the main body portion. Memory in actual use Preferably, the restraining bracket is not easily rotated or offset.

[0022] Preferably, the memory connecting segments on the same side are connected to the welding segment. In actual use, the memory is better, and it is not easy to rotate or shift the restraint bracket.

[0023] Another technical object of the present invention is to provide a non-implantable high-intensity vasodilator device that avoids excessive expansion in a blood vessel like a conventional balloon catheter, and that the blood vessel wall is softly and evenly distributed, thereby reducing the wound at the lesion site. Vascular injury at non-lesional locations reduces the incidence of other vascular complications and promotes healing.

[0024] A non-implantable high-intensity vasodilator device, comprising a balloon catheter, further comprising a high-intensity constraining stent of a non-implantable balloon catheter as described above, the balloon catheter and the constraining stent Each has a compressed configuration for insertion into a blood vessel and an expanded configuration for abutting in a blood vessel, the maximum diameter of the constraining stent in the expanded configuration being smaller than the maximum diameter of the balloon catheter in an expanded configuration.

[0025] the restraining stent is inserted into or withdrawn from the blood vessel along with the balloon catheter, and the expansion or contraction of the balloon catheter is restricted by the restraining stent to prevent the expansion from being too fast or excessively expanding to generate blood vessels. Damage

[0026] Preferably, a portion of the surface of the balloon catheter in an expanded configuration passes through the hollow portion of the memory grid unit and the hollow portion of the spacer unit to form a lattice-like convex portion that opposes the inner wall of the blood vessel. Another portion of the balloon catheter surface in the expanded configuration is blocked by a solid portion other than the hollow portion of the memory grid unit and the hollow portion of the spacer unit to form a recess relative to the raised portion.

[0027] Since the maximum diameter of the restraining bracket is smaller than the maximum diameter of the balloon catheter, the balloon catheter is extruded from the expanded memory mesh unit and the mouth of the spacing unit, the protrusion The part realizes the point force of the inner wall of the blood vessel, and the damage to the blood vessel is smaller in the uniform and gentle abutment of the blood vessel, and the concave portion forms a gap space, which provides a channel for the flow of the platelet, and allows the platelet to be slowly reconstructed. Promote wound healing, reduce or prevent restenosis, and eliminate the risk of advanced thrombosis.

Preferably, the maximum diameter of the constraining stent in the expanded configuration is 0.1 to 0.6 mm smaller than the maximum diameter of the balloon catheter in the expanded configuration.

[0029] Preferably, the balloon catheter and/or the constraining stent are coated with a drug-loaded coating.

[0030] The drug-loaded coating is in contact with the blood vessel wall of the lesion to treat the blood vessels in the lesion area and reduce the rejection reaction.

Advantageous effects of the invention

Beneficial effect [0031] Technical advantages of the present invention The high-intensity restraint stent of the non-implantable balloon catheter and the high-intensity vasodilator with the constraining stent have the advantages of simple structure, convenient use, high structural strength, good memory, and shape retention. Stable, the balloon catheter is restrained by the restraining stent to maintain a preferred expansion length and an expanded diameter in the blood vessel, and the balloon catheter is also limited and softly and evenly expanded to avoid excessive and excessive expansion of the blood vessel. Reducing a radial force and an axial force of the balloon catheter against the blood vessel wall, the balloon catheter and the restraining stent are less prone to rotation or deviation with respect to the diseased blood vessel, and the blood vessel wall is evenly sheared The whole treatment process is controllable and predictable, which greatly improves the treatment effect and reduces the risk of damage to blood vessels and complications.

Brief description of the drawing

DRAWINGS

1 is a schematic structural view showing a compression configuration of a restraining bracket according to the present invention;

2 is a schematic structural view of A in FIG. 1;

[0034] FIG. 3 is a schematic view showing the structure of an expanded shape of the restraint bracket of the present invention;

4 is a schematic structural view of B in FIG. 3;

[0036] The names of the parts corresponding to the numbers in the figure are: 1-body part, 2-fixing part, 21-memory connecting section, 22-welding section, 11-memory grid unit, 12-spacer unit, 111- A connection point, 112 - the second connection point.

Embodiments of the invention

[0037] The present invention will be further described by way of specific embodiments with reference to the accompanying drawings:

[0038] Referring to Figures 1, 2, 3, and 4, a non-implantable high-intensity vasodilator includes a balloon catheter and a constraining stent thereof, the balloon catheter is not shown, and the constraining stent includes a tubular a body portion 1 for covering the outside of the balloon catheter and a fixing portion 2 for fixing the balloon catheter connected to both ends of the body portion 1. The restraining bracket is used to follow the balloon catheter to expand or contract and inhibit the balloon The maximum expansion volume of the catheter, the balloon catheter and the constraining stent each have a compressed configuration for insertion into the blood vessel and an expanded configuration for abutting in the blood vessel, and the maximum diameter of the constraining stent in the expanded configuration is smaller than that of the balloon in the expanded configuration The maximum diameter of the balloon catheter. The constraining structure may be formed by laser cutting of a metal pipe or a polymer pipe, or may be made of a wire, a polymer or a fiber. At least one of the balloon catheter and the constraining stent is coated with a drug-loaded coating. When the device is expanded, the drug-loaded coating contacts the lesion to transfer to the blood vessel to treat the blood vessel in the lesion area. Fixing part 2 A memory connecting section 21 connected to both ends of the main body portion 1 and a welded portion 22 connected to the memory connecting section 21 are included. The memory connecting segments 21 are alternately arranged at both ends of the main body portion 1. A soldering section 22 is commonly connected to the memory connecting section 21 on the same side. The welding section 22 can be welded by a relatively mature joining technique such as laser welding, adhesive welding, and heat welding.

[0039] Prior to expansion of the device, the balloon catheter is in a collapsed state, constraining the stent in its original state, i.e., in an unexpanded state. The diameter of the balloon catheter in the collapsed state can range from 0.8 to 1.0 mm, and the diameter of the stent can be 1.0 to 1.3 mm after the stent is mounted to the balloon catheter. The size of the restraining stent and the balloon catheter can be different according to the size of the blood vessel, but the following relationship exists between the restraining stent and the balloon catheter. The maximum diameter of the restraining stent in the expanded state is larger than the maximum diameter of the balloon catheter in the expanded configuration. The diameter is 0.1~0.6mm, which depends mainly on the material and process used for the restraint bracket.

[0040] The main body portion 1 includes a plurality of memory grid units 11 and a spacing unit 12 located between the memory grid units 11.

The memory grid units 11 are arrayed along the longitudinal direction of the main body portion 1 and are arranged along the circumferential direction of the main body portion 1, and the adjacent memory grid units 11 are connected by a memory connection key 13. Each of the memory grid units 11 is provided with two first connection points 111 and two second connection points 112. The first storage points 111 are adjacent to each other in the longitudinal direction of the main body portion 1 through the respective first connection points 111. And a memory connection key 13 is connected, and adjacent memory grid units 11 in the circumferential direction of the main body portion 1 are connected by respective second connection points 112 and a memory connection key 13. Correspondingly, the spacing unit 12 is also arrayed as the memory grid unit 11. The length of the memory connecting key 13 (generally set to 0.1 to 0.3 mm) provided along the longitudinal direction of the main body portion 1 and the length of the side portion constituting the mesh unit 11 are 1:20 to 30, along the circumference of the main body portion 1. The length of the memory connection key 13 set in the direction (generally set to 0.04 to 0. 06 mm) is proportional to the length of the side section constituting the mesh unit 11 of 1:80 to 100, and the diameter of the memory connection key 13 and the constituent grid unit 11 The diameters of the side sections are the same, and the setting is based on the superior size and structural stability of the entire restraint bracket. The more preferred memory grid unit 11 is a diamond-shaped grid unit, and the complexity of structure and process manufacturing is small, and other polygonal embodiments are also possible, but are not listed here. After the balloon catheter is inflated, the balloon catheter and the restraining stent are uniformly expanded until fully expanded or nearly fully expanded, and a portion of the balloon catheter surface in the expanded configuration passes through the hollow portion of the memory grid unit 11 and the hollow of the spacing unit 12. Forming a lattice-shaped convex portion against the inner wall of the blood vessel, and the other portion of the surface of the balloon catheter in the expanded form is blocked by the hollow portion other than the hollow portion of the memory grid unit 11 and the hollow portion of the spacer unit 12 Compared with the concave portion of the convex portion, a high and low staggered topography is formed, and the convex portion realizes blood The point on the wall of the tube is stressed, the force on the vessel wall is uniform and the snoring state is good, the radial force on the blood vessel is reduced, and the possibility of damage is greatly reduced. The depression provides space for the flow of platelets, and the device is in the process of expanding platelets. It also changes position in blood vessels, promotes platelet remodeling, and accelerates wound healing. In the same way, the memory grid unit 11 is composed of a plurality of side segments, each of which does not coincide with the longitudinal direction of the blood vessel or the circumferential direction of the blood vessel, so that the restraining stent does not occur in the circumferential direction of the blood vessel wall after expansion or contraction. Rotation or axial offset to ensure the stable implementation of the point force. In the past, the balloon catheter may be easily rotated or displaced during the expansion process, causing tearing of the vessel wall or incomplete treatment of the lesion. Injury to non-lesional areas.

The interval between the two first connection points 111 of each memory grid unit 11 is the maximum length direction of the memory grid unit 11, and the two second connection points 112 of each memory grid unit 11 The interval between the spacers is the maximum circumferential direction of the memory grid unit 11; the maximum length direction gauge is always constant so that the main body portion 1 does not expand and contract in the longitudinal direction, and the maximum circumferential direction spacer is along with the memory grid unit 11 The expansion or contraction changes to cause the body portion 1 to expand or contract in the radial direction. The length and diameter of the restraining bracket are actually determined by the memory grid unit 11, the length of the restraining bracket is constant or has no substantial change in the influence, and the diameter of the restraining bracket is variable, that is, the balloon catheter with the restraining bracket does not allow the balloon to be Partly expands according to its own characteristics or expands into the non-lesion area with less resistance, and does not cause excessive pressure on the lesion area. It reduces or eliminates the axial force and radial force of the balloon catheter to the blood vessel. The three-dimensional shear force of the balloon catheter to the blood vessel, the balloon catheter is limited to a preferred range of expansion length and diameter, which has a significantly higher compliance value than the conventional balloon catheter, effectively avoiding the "dog bone" effect. Minimize damage to blood vessels. The treatment of the entire dilatation device is controlled and predictable due to the structural design of the constraining stent, which greatly improves the effect of angioplasty.

Claims

Claim

[Claim 1] A high-strength restraint stent for a non-implantable balloon catheter, comprising: a tubular body structure for covering a body portion (1) outside the balloon catheter and connecting to the body Department (1

a fixing portion (2) at both ends for fixedly connecting the balloon catheter, the constraining bracket for expanding or contracting following the balloon catheter and suppressing a maximum expansion volume of the balloon catheter; the body portion (1) comprising a plurality of a memory grid unit (11) and a spacer unit (12) located between the memory grid unit (11), the memory grid unit (11) being arrayed along the length direction of the body portion (1) The arrays are arranged along the circumferential direction of the main body portion (1), and adjacent to the memory grid units (11) are connected by a memory connection key (13).

[Claim 2] A high-intensity restraint bracket for a non-implantable balloon catheter according to claim 1, wherein: each of said memory grid units (11) is provided with two first connections a point (11 1) and two second connection points (112), wherein the first connection point is adjacent to the memory grid unit (11) in the longitudinal direction of the main body portion (1) 111) and a memory connection key (13) connected, wherein the main body portion (1) is adjacent to the memory grid unit (11) in the circumferential direction through the respective second connection point (112) and A memory connection button (13) is connected.

[Claim 3] A high-intensity restraint bracket for a non-implantable balloon catheter according to claim 2, characterized by: two said first connections of each of said memory grid units (11) The gauge between the points (11 1) is the maximum length direction of the memory grid unit (11), and the two second connection points of each of the memory grid units (11) (112) The gauge between the spacers is the maximum circumferential direction of the memory grid unit (11); the maximum length direction gauge is always constant such that the body portion (1) does not occur in the direction of the length chamber The telescoping, the maximum circumferential direction spacing changes with expansion or contraction of the memory grid unit (11) such that the body portion (1) expands or contracts in a radial direction.

[Claim 4] A high-intensity restraint bracket for a non-implantable balloon catheter according to claim 1, characterized by: said memory connection key disposed along a length direction of said main body portion (1) a ratio of a length of 1 3) to a length of a side section constituting the mesh unit (11) is 1:20 to 30, and the memory connection key (13) is disposed along a circumferential direction of the main body portion (1) length The ratio of the lengths of the segments constituting the grid unit (11) is 1:80 to 100.

A high-intensity restraint stent for a non-implantable balloon catheter according to claim 1, characterized in that: the diameter of the memory connection key (13) and the edge portion constituting the grid unit (11) The diameter is the same.

A high-intensity restraint stent for a non-implantable balloon catheter according to claim 1, wherein: said memory grid unit (11) is composed of a plurality of side segments, each of said side segments and blood vessels Both the lengthwise direction and the circumferential direction of the blood vessel do not coincide such that the constraining stent does not undergo circumferential or axial offset relative to the vessel wall after expansion or contraction.

A high-intensity restraint stent for a non-implantable balloon catheter according to claim 1, wherein: said memory grid unit (11) has a diamond shape.

A high-intensity restraint bracket for a non-implantable balloon catheter according to claim 1, wherein: said fixing portion (2) includes a memory connecting portion (21) connected to both ends of said main body portion (1) And a welded section (22) connected to the memory connecting section (21). A non-implantable high-intensity vasodilator device, comprising a balloon catheter, further comprising: a restraining stent according to any one of claims 1-7, the balloon catheter and the constraining stent Each has a compressed configuration for insertion into a blood vessel and an expanded configuration for abutting in a blood vessel; the maximum diameter of the constraining stent in the expanded configuration is smaller than the maximum diameter of the balloon catheter in an expanded configuration.

A non-implantable high-intensity vasodilator according to claim 9, wherein: a portion of said balloon catheter surface in an expanded configuration passes through a hollow portion of said memory grid unit (11) and a hollow portion of the spacer unit (12) forms a lattice-like convex portion that opposes the inner wall of the blood vessel, and another portion of the surface of the balloon catheter in an expanded configuration is removed from the hollow portion of the memory grid unit (11) And a solid portion other than the hollow portion of the spacer unit (12) is blocked to form a recess portion with respect to the convex portion.

A non-implantable high-intensity vasodilator according to claim 9, wherein: said constraining stent has an outer diameter that is smaller than a maximum diameter of said balloon catheter in an expanded configuration. ~0.6mm.

A non-implantable high-intensity vasodilator device according to claim 9, characterized in that Wherein: the balloon catheter and/or the constraining stent are coated with a drug-loaded coating.