WO2019084865A1 - 一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 - Google Patents
一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 Download PDFInfo
- Publication number
- WO2019084865A1 WO2019084865A1 PCT/CN2017/109100 CN2017109100W WO2019084865A1 WO 2019084865 A1 WO2019084865 A1 WO 2019084865A1 CN 2017109100 W CN2017109100 W CN 2017109100W WO 2019084865 A1 WO2019084865 A1 WO 2019084865A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon catheter
- stent
- memory
- blood vessel
- implantable
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
Definitions
- the present invention relates to the field of angioplasty surgical instruments, and in particular to a restraint stent for a non-implantable balloon catheter and a blood vessel expansion device using the same.
- 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.
- 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.
- 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.
- 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.
- One of the technical objects of the present invention is to provide a constraining stent for a non-implantable balloon catheter, the restraining stent having a high structural strength, capable of allowing and following inflation or contraction of the balloon catheter, and simultaneously inhibiting the balloon catheter Complete or excessive expansion, that is, the balloon catheter is optimally expanded according to the expansion mode of the restraint stent, and the vascular injury is minimized in the same state of ensuring vasodilation.
- a constraining stent for a non-implantable balloon catheter comprising a tubular body structure for covering a body portion outside the balloon catheter and connecting to both ends of the body portion a fixing portion for fixedly connecting the balloon catheter, the constraining bracket for expanding or contracting 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 in the memory a spacing unit between the grid cells, the memory grid cells are arrayed along the length direction of the body portion and are arrayed along the circumferential direction of the body portion, and the memory cells are directly connected to each other. .
- 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.
- 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.
- the three-dimensional shear force increases the controllability and predictability of the vascular treatment process, and has excellent therapeutic effects on long-path lesions (100 ⁇ 300mm).
- the memory grid unit, the spacing unit allows the balloon to be constrained by the restraining bracket After inflation, it continues to pass through to form a protrusion that contacts the blood vessel wall, and the tube wall is uniformly and evenly expanded to support, which is also advantageous for adhesion after drug loading.
- 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 are directly connected, and the memory grid units adjacent to each other in the circumferential direction of the main body portion are directly connected by the respective second connection points.
- the memory grid units are directly connected by the first connection point and the second connection point, and the structure is as simple as possible, the consistency is good, and the memory grid unit or It is said that the restraint stent expands smoothly, and also ensures that the generation of the spacer 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, and the spacer unit forms more protrusions.
- the array and the corresponding array of depressions, the convex array is gently and evenly contacted with the blood vessel wall, and it is easier to smash the lesion, and the array of the same depression provides space for the flow of platelets, ensuring circulation, allowing platelet remodeling, promoting Wound healing, minimizing or preventing restenosis, and eliminating the risk of late thrombosis.
- 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.
- 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 expanded 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 created after the passage, and the balloon catheter is only allowed to reach a limited, predetermined expansion diameter due to the limitation of the stent diameter.
- the balloon compliance value is significantly higher than that of the conventional 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. It is possible to avoid the formation of vascular dissection and reduce the rate of restenosis of blood vessels.
- the memory grid unit is designed to be smaller, the nominal pressure and burst pressure of the balloon are higher.
- 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 such that the restraining bracket expands or contracts. No circumferential or axial offset of the opposing vessel wall occurs.
- 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.
- 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.
- 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.
- the memory is better, and it is not easy to rotate or shift the restraint bracket.
- the memory connecting segments are staggered at two ends of the main body portion.
- the memory is better, and it is not easy to rotate or shift the restraint bracket.
- the memory connecting segments on the same side are connected to the welding segment.
- the memory is better, and it is not easy to rotate or shift the restraint bracket.
- Another technical object of the present invention is to provide a non-implantable 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, reducing lesion location and non-lesional lesions. Position vascular injury, reduce the incidence of other vascular complications, and promote healing.
- a non-implantable vasodilator device comprising a balloon catheter, further comprising a constraining stent as described above, the balloon catheter and the constraining stent each having 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 an expanded configuration being smaller than the maximum diameter of the balloon catheter in an expanded configuration.
- 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
- 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.
- the balloon catheter 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.
- 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.
- the balloon catheter and/or the constraining stent are coated with a drug-loaded coating.
- 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.
- the constrained stent of the non-implantable balloon catheter and the vascular dilating device with the constraining stent are simple in structure and convenient to use, and the balloon catheter is restricted by the constraining stent and is in the blood vessel Maintaining a preferred expansion length and expanded diameter, the same balloon catheter is also limited and softly and evenly expanded, avoiding excessive and excessive expansion of the blood vessel, reducing the radial force of the balloon catheter to the vessel wall and The axial force, the balloon catheter and the restraining stent are less prone to rotation or deviation with respect to the diseased blood vessel, the shearing force of the blood vessel wall is uniform, and the entire treatment process is controllable and predictable, which is extremely It improves the treatment effect and reduces the risk of damage to blood vessels and complications.
- 1 is a schematic structural view showing a compression configuration of a restraint bracket according to the present invention
- 2 is a schematic structural view of an expansion structure of a restraining bracket according to the present invention
- a non-implantable vasodilator device includes a balloon catheter and a restraining stent thereof, the balloon catheter is not shown, and the restraining stent includes a tubular structure for coating the balloon.
- the constraining stents each have a compressed configuration for insertion into the blood vessel and an expanded configuration for abutting in the blood vessel, the maximum diameter of the constraining stent in the expanded configuration being smaller than the maximum diameter of the balloon catheter in the expanded configuration.
- 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.
- the fixing portion 2 includes a memory connecting portion 21 connected to both ends of the main body portion 1 and a welded portion 22 connected to the memory connecting portion 21.
- the memory connecting sections 21 are alternately arranged at both ends of the main body portion 1.
- the same side of the memory connecting section 21 is connected to a welded section 22 in common.
- the welding section 22 can be welded by laser welding, adhesive welding, heat welding, etc.
- the balloon catheter 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.
- 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 arrayed along the circumferential direction of the main body portion 1, and the adjacent memory grid units 11 are directly connected.
- Two first connections are provided on each memory grid unit 11 Point 111 and two second connection points 112, the adjacent memory grid units 11 in the longitudinal direction of the main body portion 1 are directly connected by respective first connection points 111, and the adjacent memory grids of the main body portion 1 in the circumferential direction
- the units 11 are directly connected by respective second connection points 112.
- the spacing unit 12 is also arrayed as the memory grid unit 11.
- 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.
- 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.
- the convex portion realizes the point force of the blood vessel wall, the blood vessel wall is uniformly stressed and the snoring state is good, and the radial force received by the blood vessel is reduced, and the damage may be damaged.
- the sex is greatly reduced, and the depression provides space for the flow of platelets.
- the platelets also change position in the blood vessels, promote platelet remodeling, and accelerate wound healing.
- 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.
- 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.
- the gauge 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 dimensions of each memory grid unit 11
- the interval between the two connection points 112 is the maximum circumferential direction of the memory grid unit 11; the maximum length direction interval is always constant, so that the main body portion 1 does not expand and contract in the longitudinal direction, and the maximum circumferential direction interval is The expansion or contraction of the memory grid unit 11 is changed such that the main body portion 1 expands or contracts 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 on the blood vessel, the balloon catheter is limited to a better range of expansion length and diameter, which is significantly higher than the transmission
- the compliance value of the balloon catheter effectively avoids the "dog bone" effect. Minimize damage to blood vessels.
- the treatment process of the entire expansion device is controllable and predictable due to the structural design of the restraining stent, which greatly improves the effect of angioplasty surgery.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Child & Adolescent Psychology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
一种非植入式球囊导管的约束支架，包括呈管状结构的用于包覆在球囊导管外的主体部（1）和连接于主体部（1）两端的用于固定连接球囊导管的固定部（2），约束支架用于跟随球囊导管膨胀或收缩并抑制球囊导管的最大膨胀体积；一种非植入式血管扩张装置，包括球囊导管，还包括前述的约束支架，球囊导管与约束支架各自具有用于置入血管中的压缩形态和用于在血管中抵扩的膨胀形态，膨胀形态下的约束支架的最大直径小于膨胀形态下的球囊导管的最大直径。本发明结构简单、使用方便，改善了治疗效果，降低了对血管的损伤及并发症的发生概率。
Description
一种非植入式球囊导管的约束支架及应用该约束支架的 血管扩张装置
技术领域
[0001] 本发明涉及血管成形手术器具技术领域， 具体涉及一种非植入式球囊导管的约 束支架及应用该约束支架的血管扩张装置。
背景技术
[0002] 对于心血管疾病， 球囊血管成型术是最常用的治疗手段之一。 传统的球囊导管 根据患者血管的大小及病变位置的长短， 制作成不同直径及长度的被充气后成 圆柱状的球囊， 其工作原理为： 利用输送系统， 将一个球囊扩张导管放置于病 变处， 气囊充气后， 血管被扩张， 实现管腔扩大。
[0003] 传统的球囊血管成形术常常伴随着血管的损伤， 如因球囊扩张过程中球囊近端 、 远端直径大于球囊中部直径， 即"狗骨头效应"， 导致球囊两端接触的血管过度 扩张， 造成血管壁损伤并且导致球囊纵向伸长加速血管夹层 （〉30%) ， 同吋可 引发病变部位的急性血管闭塞 （5%~12%) 以及术后再狭窄 （50%) 。
[0004] 由于传统的球囊血管成形术存在诸多的血管损伤， 因此常常被用作心血管疾病 的初期治疗手段， 在初期治疗后往往会植入裸支架或药物支架。 尽管金属裸支 架和药物支架已被证实其治疗后的通畅率优于球囊血管成形术， 但是依然存在 长期植入的不良临床结果以及晚期的再狭窄， 特别是下肢动脉对支架产生的动 态应力可能会导致支架断裂或支架内再狭窄。
[0005] 血管夹层、 急性血管闭塞、 血管壁损伤都是较为严重的血管创伤， 这种创伤的 形成与使用传统球囊的血管成形术的作用机理关系密切。
[0006] 传统的球囊导管作用机理包括折叠的球囊在膨胀过程中扭转施加给血管壁的剪 切力； 由于传统球囊受结构和材料的限制， 以及血管病变部位的形态差异， 各 向异性的特点， 导致在使用过程中球囊存在不可避免的"狗骨头效应"， 引起血管 的进一步创伤以及非病变区的血管损伤。
[0007] 如专利号为 CN105963848A的专利文件公幵了一种球囊导管， 具备： 球囊； 夕卜
侧管， 其连接于上述球囊的基端； 内侧管， 其配置于上述外侧管的内部， 该内 侧管的顶端连接于上述球囊的顶端； 在上述内侧管的外周形成的凹凸部； 以及 芯线， 其配置于上述外侧管与上述内侧管之间， 其中， 上述芯线具备被夹持在 上述外侧管与上述凹凸部的凹部之间的膨隆部， 其虽然能确保球囊导管的柔软 性和推拉力的良好传递， 但是仍然存在前述所述问题。
技术问题
问题的解决方案
技术解决方案
[0008] 本发明的技术目的之一在于提供一种非植入式球囊导管的约束支架， 所述约束 支架结构强度高， 能够允许并跟随球囊导管膨胀或收缩， 同吋抑制球囊导管完 全或过度膨胀， 即球囊导管以所述约束支架的扩张方式为标准进行最佳化扩张 ， 在保证血管扩张的同吋实现对血管损伤最小化。
[0009] 本发明的具体技术方案如下： 一种非植入式球囊导管的约束支架， 包括呈管状 结构的用于包覆在球囊导管外的主体部和连接于所述主体部两端的用于固定连 接球囊导管的固定部， 所述约束支架用于跟随球囊导管膨胀或收缩并抑制球囊 导管的最大膨胀体积； 所述主体部包括多个记忆网格单元和位于所述记忆网格 单元之间的间隔单元， 所述记忆网格单元沿着所述主体部长度方向阵列并同吋 沿着所述主体部周长方向阵列， 相邻所述记忆网格单元之间直接连接。
[0010] 所述约束支架将整个球囊导管包裹， 并在球囊导管的近端和远端进行固定连接
， 所述约束支架本身不易从球囊导管上脱落， 与球囊导管一同插入或撤出。 所 述约束支架有一初始皱缩状态并紧贴于球囊部分表面， 使球囊部分的直径在皱 缩状态吋尽可能小。 所述约束支架随着球囊部分充气而缓慢扩张， 球囊部分受 所述约束支架限制而均匀柔和扩张， 球囊部分不会因自身特性而瞬间扩起或往 阻力更小的非病变区扩张， 而对血管壁或非病变区造成损伤。 在球囊充气吋或 者泄压吋， 约束支架对球囊的长度、 直径及扩张速率都能进行有效控制， 减少 或消除球囊对血管的轴向力及径向力， 分散球囊对血管的三维剪切力， 增加了 对血管治疗过程的可控性和可预见性， 对长病变血管 （100~300mm) 有极佳的 治疗效果。 所述记忆网格单元、 所述间隔单元允许球囊在受所述约束支架限制
膨胀后继续穿过而产生接触血管壁的凸起， 对血管壁进行必要地均匀地扩起支 撑， 也利于载药后的贴触。
[0011] 作为优选， 每个所述记忆网格单元上设有两个第一连接点和两个第二连接点， 所述主体部的长度方向上相邻所述记忆网格单元之间通过各自的所述第一连接 点直接相连， 所述主体部的圆周方向上相邻所述记忆网格单元之间通过各自所 述第二连接点直接相连。
[0012] 所述记忆网格单元之间通过所述第一连接点和所述第二连接点直接连接， 在结 构上做到尽可能简化， 一致性良好， 并使得所述记忆网格单元或者说所述约束 支架扩张顺畅， 也保证所述间隔单元的生成及其空间占比尽可能大， 有利于球 囊导管膨胀后穿过所述记忆网格单元、 所述间隔单元形成较多凸起阵列和相对 应的凹陷阵列， 凸起阵列与血管壁柔和均匀接触， 更容易将病变部位打幵， 同 吋凹陷阵列为血小板的流动提供了空间， 保证了流通性， 允许血小板的重构， 促进创伤愈合， 尽可能减少或预防再狭窄， 排除晚期血栓形成的危险。
[0013] 作为优选， 每个所述记忆网格单元的两个所述第一连接点之间的隔距为该所述 记忆网格单元的最大长度方向隔距， 每个所述记忆网格单元的两个所述第二连 接点之间的隔距为该所述记忆网格单元的最大圆周方向隔距； 所述最大长度方 向隔距始终不变而使得所述主体部在长度房方向上不发生伸缩， 所述最大圆周 方向隔距随所述记忆网格单元膨胀或收缩发生改变而使得所述主体部在径向方 向上膨胀或收缩。
[0014] 这样设置限定了所述记忆网格单元的膨胀大小， 即实际上所述约束支架因所述 记忆网格单元的这一膨胀特性， 最终支架长度无实质变化或者说仅发生非常轻 微的数值变化， 而支架直径可变且存在用于抑制球囊导管的最大膨胀直径的数 值， 也即当球囊内压力进一步增加吋， 球囊导管不会伸长或有轻微的轴向伸长 ， 所述记忆网格单元与所述间隔单元的存在使得球囊导管由于穿过后产生的阻 力更加难以拉长， 同吋由于支架直径的限制， 球囊导管只被允许达到有限的、 既定的膨胀直径， 这种情况下的球囊顺应性值显著高于传统球囊， 有效避免"狗 骨头效应"， 球囊导管的充气膨胀具有可预见性， 受到有效控制， 也因此大大减 少了非病变区域的受损伤可能， 避免血管夹层的产生， 降低血管的再狭窄率。
另外若所述记忆网格单元设计得越小， 球囊的名义压力及爆破压力就越高。
[0015] 作为优选， 所述记忆网格单元由多个边段构成， 每个所述边段与血管的长度方 向和血管的周长方向均不重合而使得所述约束支架在膨胀或收缩吋不发生相对 血管壁的周向旋转或轴向偏移。
[0016] 这样设计使得所述记忆网格单元在膨胀或收缩吋， 其每个所述边段都不会沿着 血管的长度方向、 周长方向伸长或缩短， 也就是在变化过程中所述边段会始终 在异于血管的长度方向、 周长方向上位移并产生均匀分散的剪切力， 容易将病 变部位打幵， 减少对血管壁的损伤， 并且不会使得整个所述约束支架发生周向 旋转或轴向偏移。
[0017] 作为优选， 所述记忆网格单元呈菱形。 菱形的网格能完美符合前述的设计条件 ， 两条对角线分别与血管的长度方向和周长方向重合， 沿着血管周向方向上的 两个顶点即所述第二连接点， 沿着血管长度方向上的两个顶点即所述第一连接 点， 每一边段都不与血管长度方向、 周长方向重合， 准确稳定地在病变部位与 球囊导管一起扩张。 结构复杂程度低， 工艺制作较为简单， 易于实现。
[0018] 作为优选， 所述固定部包括连接于所述主体部两端的记忆连接段和连接于所述 记忆连接段的焊接段。 实际使用中记忆性较好， 且不易使所述约束支架旋转或 偏移。
[0019] 作为优选， 所述记忆连接段交错分设于所述主体部的两端。 实际使用中记忆性 较好， 且不易使所述约束支架旋转或偏移。
[0020] 作为优选， 同侧的所述记忆连接段共同连接有一所述焊接段。 实际使用中记忆 性较好， 且不易使所述约束支架旋转或偏移。
[0021] 本发明的另一技术目的在于提供一种非植入式血管扩张装置， 避免如传统球囊 导管那样在血管内过度扩张， 且血管壁受力柔和均匀， 减少病变位置创伤和非 病变位置血管损伤， 减少其他血管并发症的发生概率， 促进愈合。
[0022] 一种非植入式血管扩张装置， 包括球囊导管， 还包括如前所述的约束支架， 所 述球囊导管与所述约束支架各自具有用于置入血管中的压缩形态和用于在血管 中抵扩的膨胀形态， 膨胀形态下的所述约束支架的最大直径小于膨胀形态下的 所述球囊导管的最大直径。
[0023] 所述约束支架随所述球囊导管一起置入血管或从中撤出， 所述球囊导管的膨胀 或收缩受到所述约束支架的限制， 避免扩张过快或过度扩张而对血管产生损伤
[0024] 作为优选， 膨胀形态下的所述球囊导管表面一部分穿过所述记忆网格单元的空 心部及所述间隔单元的空心部而形成抵触血管内壁的点阵状的凸起部， 膨胀形 态下的所述球囊导管表面另一部分被除所述记忆网格单元的空心部及所述间隔 单元的空心部之外的实心部阻挡而形成相对于所述凸起部的凹陷部。
[0025] 由于所述约束支架的最大直径小于所述球囊导管的最大直径， 所述球囊导管从 扩张的所述记忆网格单元及所述间隔单元的口子中挤出， 所述凸起部实现了血 管内壁的点受力， 在均匀、 柔和抵扩血管的同吋， 对血管的损伤更小， 所述凹 陷部形成间隙空间， 为血小板的流动提供了通道， 允许血小板慢慢重构， 促进 创伤愈合， 减少或预防再狭窄， 排除晚期血栓形成的危险。
[0026] 作为优选， 膨胀形态下的所述约束支架的最大直径比膨胀形态下的所述球囊导 管的最大直径小 0.1~0.6mm。
[0027] 作为优选， 所述球囊导管和 /或所述约束支架上覆有载药涂层。
[0028] 载药涂层与病变处血管壁接触， 治疗病变区域血管， 减少排异反应。
发明的有益效果
有益效果
[0029] 本发明的技术优点所述非植入式球囊导管的约束支架及带有该约束支架的血管 扩张装置结构简单、 使用方便， 所述球囊导管受所述约束支架限制而在血管中 保持较佳的扩张长度和扩张直径， 同吋球囊导管也受限而柔和均匀地扩张， 避 免对血管的过快、 过度扩张， 减小所述球囊导管对血管壁的径向力和轴向力， 所述球囊导管和所述约束支架不易发生相对于病变血管的旋转或偏移， 血管壁 所受剪切力均匀， 整个治疗过程具有可控性和可预见性， 极大的改善了治疗效 果， 降低了对血管的损伤及并发症的发生概率。
对附图的简要说明
附图说明
[0030] 图 1为本发明所述约束支架的压缩形态结构示意图；
[0031] 图 2为本发明所述约束支架的膨胀形态结构示意图；
[0032] 图中编号对应的各部位名称分别为： 1-主体部， 2-固定部， 21-记忆连接段， 22 -焊接段， 11-记忆网格单元， 12-间隔单元， 111-第一连接点， 112-第二连接点。
本发明的实施方式
[0033] 下面将结合附图， 通过具体实施例对本发明作进一步说明：
[0034] 见图 1、 图 2， 一种非植入式血管扩张装置， 包括球囊导管及其约束支架， 球囊 导管未示出， 约束支架包括呈管状结构的用于包覆在球囊导管外的主体部 1和连 接于主体部 1两端的用于固定连接球囊导管的固定部 2， 约束支架用于跟随球囊 导管膨胀或收缩并抑制球囊导管的最大膨胀体积， 球囊导管与约束支架各自具 有用于置入血管中的压缩形态和用于在血管中抵扩的膨胀形态， 膨胀形态下的 约束支架的最大直径小于膨胀形态下的球囊导管的最大直径。 约束结构可有金 属管材、 聚合物管材通过激光切割而成， 也可由金属丝、 聚合物或纤维编制而 成。 球囊导管和约束支架至少有一个覆有载药涂层， 当装置扩张后， 载药涂层 与病变处接触转移至血管上， 治疗病变区域血管。 固定部 2包括连接于主体部 1 两端的记忆连接段 21和连接于记忆连接段 21的焊接段 22。 记忆连接段 21交错分 设于主体部 1的两端。 同侧的记忆连接段 21共同连接有一焊接段 22。 焊接段 22的 焊接方式可通过激光焊接、 粘合剂焊接、 热焊接等本领域较为成熟的连接技术
[0035] 本装置扩张前， 球囊导管处于皱缩状态， 约束支架处于原始状态， 即未扩张状 态。 皱缩状态的球囊导管直径范围可为 0.8~1.0mm， 约束支架安装至此吋的球囊 导管上后整个装置直径范围可为 1.0~1.3mm。 约束支架和球囊导管的大小可根据 血管的大小而制定不同规格， 但约束支架与球囊导管之间存在以下关系， 膨胀 形态下的约束支架的最大直径比膨胀形态下的球囊导管的最大直径小 0.1~0.6mm ， 主要取决于约束支架所采用的材质及工艺。
[0036] 主体部 1包括多个记忆网格单元 11和位于记忆网格单元 11之间的间隔单元 12。
记忆网格单元 11沿着主体部 1长度方向阵列并同吋沿着主体部 1周长方向阵列， 相邻记忆网格单元 11之间直接连接。 每个记忆网格单元 11上设有两个第一连接
点 111和两个第二连接点 112， 主体部 1的长度方向上相邻记忆网格单元 11之间通 过各自的第一连接点 111直接相连， 主体部 1的圆周方向上相邻记忆网格单元 11 之间通过各自第二连接点 112直接相连。 相应的， 间隔单元 12也如记忆网格单元 11那般阵列。 较优选的记忆网格单元 11为菱形网格单元， 结构及工艺制造的复 杂度较小， 其他多边形实施例也可实现， 但此处并未罗列出。 在球囊导管充气 膨胀吋， 球囊导管与约束支架均匀扩起直至完全扩张或接近完全扩张， 膨胀形 态下的球囊导管表面一部分穿过记忆网格单元 11的空心部及间隔单元 12的空心 部而形成抵触血管内壁的点阵状的凸起部， 膨胀形态下的球囊导管表面另一部 分被除记忆网格单元 11的空心部及间隔单元 12的空心部之外的实心部阻挡而形 成相对于凸起部的凹陷部， 形成高低交错的形貌， 凸起部实现血管壁的点受力 ， 血管壁受力均匀且打幵状态良好， 减少了血管受到的径向力， 受损伤可能性 大大降低， 凹陷部为血小板的流动提供了空间， 装置在扩张过程中血小板也在 血管中改变着位置， 促进血小板的重构， 加速创伤的愈合。 同吋， 记忆网格单 元 11由多个边段构成， 每个边段与血管的长度方向或血管的周长方向均不重合 而使得约束支架在膨胀或收缩吋不发生相对血管壁的周向旋转或轴向偏移， 保 证点受力的稳定实现， 以往的球囊导管可能会在扩张过程中容易发生旋转或偏 移， 造成对血管壁的撕扯或是对病变部位的不完全治疗、 对非病变部位的误伤 每个记忆网格单元 11的两个第一连接点 111之间的隔距为该记忆网格单元 11的 最大长度方向隔距， 每个记忆网格单元 11的两个第二连接点 112之间的隔距为该 记忆网格单元 11的最大圆周方向隔距； 最大长度方向隔距始终不变而使得主体 部 1在长度方向上不发生伸缩， 最大圆周方向隔距随记忆网格单元 11膨胀或收缩 发生改变而使得主体部 1在径向方向上膨胀或收缩。 约束支架的长度和直径实际 由记忆网格单元 11决定， 约束支架的长度不变或无实质影响的轻微变化， 约束 支架的直径可变， 也即带约束支架的球囊导管不会让球囊部分根据自身的特性 瞬间扩起或往阻力更小的非病变区扩张， 也不会对病变区意外产生过大的压力 ， 减少或消除球囊导管对血管的轴向力及径向力， 分散球囊导管对血管的三维 剪切力， 球囊导管被限制在较佳的扩张长度和直径范围内， 其具有显著高于传
统球囊导管的顺应性值， 有效避免"狗骨头"效应。 尽可能减轻对血管的损伤。 整 个扩张装置的治疗过程因为约束支架的结构设计而有了可控性及可预见性， 极 大地改善血管成形手术的效果。
Claims
权利要求书
一种非植入式球囊导管的约束支架， 其特征在于： 包括呈管状结构的 用于包覆在球囊导管外的主体部 （1) 和连接于所述主体部 （1) 两端 的用于固定连接球囊导管的固定部 （2) ， 所述约束支架用于跟随球 囊导管膨胀或收缩并抑制球囊导管的最大膨胀体积； 所述主体部 （1 ) 包括多个记忆网格单元 （11) 和位于所述记忆网格单元 （11) 之间 的间隔单元 （12) ， 所述记忆网格单元 （11) 沿着所述主体部 （1) 长度方向阵列并同吋沿着所述主体部 （1) 周长方向阵列， 相邻所述 记忆网格单元 （11) 之间直接连接。
根据权利要求 1所述的一种非植入式球囊导管的约束支架， 其特征在 于： 每个所述记忆网格单元 （11) 上设有两个第一连接点 （111) 和 两个第二连接点 （112) ， 所述主体部 （1) 的长度方向上相邻所述记 忆网格单元 （11) 之间通过各自的所述第一连接点 （111) 直接相连 ， 所述主体部 （1) 的圆周方向上相邻所述记忆网格单元 （11) 之间 通过各自所述第二连接点 （112) 直接相连。
根据权利要求 2所述的一种非植入式球囊导管的约束支架， 其特征在 于： 每个所述记忆网格单元 （11) 的两个所述第一连接点 （111) 之 间的隔距为该所述记忆网格单元 （11) 的最大长度方向隔距， 每个所 述记忆网格单元 （11) 的两个所述第二连接点 （112) 之间的隔距为 该所述记忆网格单元 （11) 的最大圆周方向隔距； 所述最大长度方向 隔距始终不变而使得所述主体部 （1) 在长度房方向上不发生伸缩， 所述最大圆周方向隔距随所述记忆网格单元 （11) 膨胀或收缩发生改 变而使得所述主体部 （1) 在径向方向上膨胀或收缩。
根据权利要求 1所述的一种非植入式球囊导管的约束支架， 其特征在 于： 所述记忆网格单元 （11) 由多个边段构成， 每个所述边段与血管 的长度方向和血管的周长方向均不重合而使得所述约束支架在膨胀或 收缩吋不发生相对血管壁的周向旋转或轴向偏移。
根据权利要求 1所述的一种非植入式球囊导管的约束支架， 其特征在
于： 所述记忆网格单元 （11) 呈菱形。
根据权利要求 1所述的一种非植入式球囊导管的约束支架， 其特征在 于： 所述固定部 （2) 包括连接于所述主体部 （1) 两端的记忆连接段
(21) 和连接于所述记忆连接段 （21) 的焊接段 （22) 。
根据权利要求 6所述的一种非植入式球囊导管的约束支架， 其特征在 于： 所述记忆连接段 （21) 交错分设于所述主体部 （1) 的两端。 根据权利要求 6所述的一种非植入式球囊导管的约束支架， 其特征在 于： 同侧的所述记忆连接段 （21) 共同连接有一所述焊接段 （22) 。 一种非植入式血管扩张装置， 包括球囊导管， 其特征在于： 还包括如 权利要求 1~7任一项所述的约束支架， 所述球囊导管与所述约束支架 各自具有用于置入血管中的压缩形态和用于在血管中抵扩的膨胀形态 ； 膨胀形态下的所述约束支架的最大直径小于膨胀形态下的所述球囊 导管的最大直径。
根据权利要求 9所述的一种非植入式血管扩张装置， 其特征在于： 膨 胀形态下的所述球囊导管表面一部分穿过所述记忆网格单元 （11) 的 空心部及所述间隔单元 （12) 的空心部而形成抵触血管内壁的点阵状 的凸起部， 膨胀形态下的所述球囊导管表面另一部分被除所述记忆网 格单元 （11) 的空心部及所述间隔单元 （12) 的空心部之外的实心部 阻挡而形成相对于所述凸起部的凹陷部。
根据权利要求 9所述的一种非植入式血管扩张装置， 其特征在于： 膨 胀形态下的所述约束支架的最大直径比膨胀形态下的所述球囊导管的 最大直径小 0. l~0.6mm。
根据权利要求 9所述的一种非植入式血管扩张装置， 其特征在于： 所 述球囊导管和 /或所述约束支架上覆有载药涂层。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2017/109100 WO2019084865A1 (zh) | 2017-11-02 | 2017-11-02 | 一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2017/109100 WO2019084865A1 (zh) | 2017-11-02 | 2017-11-02 | 一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2019084865A1 true WO2019084865A1 (zh) | 2019-05-09 |
Family
ID=66332760
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2017/109100 WO2019084865A1 (zh) | 2017-11-02 | 2017-11-02 | 一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2019084865A1 (zh) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6245040B1 (en) * | 1994-01-14 | 2001-06-12 | Cordis Corporation | Perfusion balloon brace and method of use |
| CN104168859A (zh) * | 2012-02-08 | 2014-11-26 | 夸超脉管私人有限公司 | 具有非线性轴向支柱的约束结构 |
-
2017
- 2017-11-02 WO PCT/CN2017/109100 patent/WO2019084865A1/zh active Application Filing
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6245040B1 (en) * | 1994-01-14 | 2001-06-12 | Cordis Corporation | Perfusion balloon brace and method of use |
| CN104168859A (zh) * | 2012-02-08 | 2014-11-26 | 夸超脉管私人有限公司 | 具有非线性轴向支柱的约束结构 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN106456347B (zh) | 减少肉芽和炎症的支架设计 | |
| US10220193B2 (en) | Device for compartmental dilatation of blood vessels | |
| JP2933226B2 (ja) | 伸張可能な管腔内脈管移植片及び身体通路の管腔を伸張させる装置 | |
| EP2326292B1 (en) | Self-expanding medical device | |
| US5800519A (en) | Tubular medical prosthesis for use in a body lumen | |
| JP3756185B2 (ja) | 投薬装置付きステント配置装置及びその方法 | |
| JP6050805B2 (ja) | ステント | |
| US20070129793A1 (en) | Expandable biodegradable polymeric stents for combined mechanical support and pharmacological or radiation therapy | |
| AU2001273018B2 (en) | Intraluminal stents | |
| US20040133270A1 (en) | Drug eluting stent and methods of manufacture | |
| JP2000509304A (ja) | 局部化管内バルーン | |
| US20110004291A1 (en) | Ostium support for treating vascular bifurcations | |
| JPH02174859A (ja) | 伸張可能な管腔内移植片 | |
| US20060009832A1 (en) | Balloon catheter and method and system for securing a stent to a balloon catheter | |
| US20090234429A1 (en) | Self-restraining endoluminal prosthesis | |
| JP2006502801A (ja) | 展開制御型バルーン | |
| KR19990087472A (ko) | 팽창가능한 스텐트 | |
| CN107835676A (zh) | 气囊导管 | |
| JP2022517181A (ja) | 静脈狭窄管理の為のオーセチックステント | |
| JP4929289B2 (ja) | バルーンカテーテル | |
| CN207970164U (zh) | 一种非植入式球囊导管的高强度约束支架及应用该约束支架的血管扩张装置 | |
| JP2009515666A (ja) | 分岐ステント給送システム | |
| CN114870213A (zh) | 球囊约束支架及球囊导管 | |
| WO2019084951A1 (zh) | 一种非植入式球囊导管的高强度约束支架及应用该约束支架的血管扩张装置 | |
| CN107582130A (zh) | 一种非植入式球囊导管的约束支架及应用该约束支架的血管扩张装置 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 17930554 Country of ref document: EP Kind code of ref document: A1 |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| 32PN | Ep: public notification in the ep bulletin as address of the adressee cannot be established |
Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205 DATED 24.06.2020) |
|
| 122 | Ep: pct application non-entry in european phase |
Ref document number: 17930554 Country of ref document: EP Kind code of ref document: A1 |