WO2018218781A1 - 一种定向挤压球囊扩张导管 - Google Patents

一种定向挤压球囊扩张导管 Download PDF

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Publication number
WO2018218781A1
WO2018218781A1 PCT/CN2017/094640 CN2017094640W WO2018218781A1 WO 2018218781 A1 WO2018218781 A1 WO 2018218781A1 CN 2017094640 W CN2017094640 W CN 2017094640W WO 2018218781 A1 WO2018218781 A1 WO 2018218781A1
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balloon
catheter
directional
catheter body
layer
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PCT/CN2017/094640
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English (en)
French (fr)
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刘逸
刘志忠
祁玉珍
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刘逸
刘志忠
祁玉珍
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Priority claimed from CN201720625577.0U external-priority patent/CN207928567U/zh
Priority claimed from CN201710403451.3A external-priority patent/CN107802944A/zh
Application filed by 刘逸, 刘志忠, 祁玉珍 filed Critical 刘逸
Publication of WO2018218781A1 publication Critical patent/WO2018218781A1/zh

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    • 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 invention belongs to the field of medical instruments, and relates to a balloon dilatation catheter for interventional medical treatment, in particular to a directional squeeze balloon dilatation catheter.
  • PCI percutaneous coronary intervention
  • Conventional PTCA uses a semi-compliant or non-compliant balloon to expand the vascular lesion.
  • the lumen is enlarged by radial compression and wall expansion (almost 50% [4] ), with plaque axial Shift [5] .
  • the anatomical enlargement of mixed plaque or calcified plaque is caused by irregular plaque tear and dissection [6] , as shown in Figure 1.
  • the consequence of this expansion is that it destroys the original integrity of the lesion, and the plaque migrates along the axial direction of the blood vessel, which not only causes the involvement of the side branch, but also causes the artificial lipid core component to be artificially enlarged and the endovascular membrane is damaged.
  • the middle membrane breaks the outer membrane tension bulging, which in turn promotes the body's proliferative repair reaction. Therefore, when the anatomical lumen is increased, in turn, the vascular mechanical trauma, inflammation spreads, and plaque rupture shifts.
  • the traditional intravascular balloon angioplasty does not really reduce the volume of atherosclerotic plaque on the one hand, especially the component that does not reduce inflammation, on the other hand, it leads to the activation, expansion and endometrial inflammation of the wall. Integrity damage is the main reason for the limited benefits of traditional PCI. How to reduce the nucleus load of atherosclerotic plaque (the main component of inflammation) and maximize the protection of the endothelial layer is an urgent problem to be solved.
  • the patented CN201394274Y and CN204395193 involve a double-layer balloon to solve the possibility that a single-layer balloon may be broken.
  • the problem is that the inner and outer balloons have the same material and shape; they can not solve the problem of nucleosis load of atherosclerotic plaque and protect the endothelial layer.
  • the patents CN201135683 [P] and CN105662668A provide a single-layer conical balloon for the expansion of the lesions of the vessel segments with large diameter drop and improve the passability, but still can not solve the problem of the fat load of the atherosclerotic plaque. And protect the endothelial layer.
  • the invention is inspired by the treatment of clinical abscesses.
  • a prominent feature of suppurative disease is that there is a strong and inflamed cystic parcel in the center, and the periphery is a multi-layered structure surrounded by inflammatory cells.
  • the most effective treatment for abscesses is to open the drainage, and only the core of the abscess can be cured.
  • Atherosclerotic lesions are similar, and it is speculated that the lesion must be cut and the lipid nucleus is removed to reduce the inflammatory effect, which can fundamentally improve the prognosis of atherosclerotic lesions.
  • the key advantage of the technology provided by the present invention is that the endothelial tissue is protected to the greatest extent while removing pathological tissues such as lipid nucleus.
  • the present invention provides a directional squeeze balloon which aims to reduce plaque volume by directional expansion of the balloon, avoid branch involvement, and maximize endothelial protection. .
  • a directional squeeze balloon dilatation catheter comprising a catheter body and a double-layer balloon connected to the distal body of the catheter body, the proximal body of the catheter body is provided with an external input port a connecting member, a developing ring is disposed in the balloon; the double-layer balloon is designed as a coaxial phase sleeve centered on the catheter body; and the inner layer and the outer layer of the double-layer balloon are respectively sealed with the catheter body
  • the inner balloon has high compliance.
  • the preform is shaped into a first taper, a cylindrical working A segment, a truncated cone working B segment and a second taper;
  • the catheter body comprises three independent cavities, the central cavity is a guide wire lumen, and the two lateral cavities of the catheter body are an inner balloon communication cavity and an outer balloon communication cavity, and the inner balloon communication cavity and the outer cavity
  • One end of the balloon communication cavity communicates with the connecting member, and the other end communicates with the inner layer balloon and the outer layer balloon through the inlet and outlet holes respectively;
  • the access hole on the outer balloon connecting cavity is disposed in the inner layer balloon and the outer layer balloon
  • the access hole on the inner balloon connecting cavity is disposed in the inner balloon.
  • the key to the present invention is the design of the directional squeeze balloon, which is not limited to the catheter system, and may be a fast exchange balloon catheter or a coaxial exchange balloon catheter.
  • the guidewire outlet is in the middle of the balloon dilation catheter (the body of the catheter between the connector and the balloon), it is referred to as a quick exchange balloon catheter; if the guidewire outlet is in the connector The end is called a coaxial-on-the-wire.
  • one end of the guide wire lumen is connected to the guide wire tube, and the other end is open at the outlet of the guide wire, and the outlet of the guide wire is located at the body of the catheter between the connector and the balloon or at the external input port connector.
  • the connecting member has two independent ports, which are respectively connecting ports of the inner and outer balloon connecting chambers; the two connecting ports are respectively provided with bidirectional rotary switches.
  • the connector can have three separate ports that communicate with the three lumens of the catheter body, respectively.
  • the outer balloon has non-compliance, and the working section has a conventional shape.
  • the working section has a conventional shape.
  • it can be designed into a cylindrical or truncated cone shape (Fig. 3) according to the characteristics of the blood vessel diameter, and includes the first when the pressure is filled.
  • Cone cylindrical working A section and cylindrical or truncated B section, second taper. Due to its non-compliance, it constitutes a limitation on the expansion of the inner balloon.
  • the cylindrical working A and B sections of the outer balloon correspond to the cylindrical working A section of the inner balloon and the frustum shaped working B section.
  • the inner layer balloon has compliance, and the working section is pre-shaped into a cylinder A section + a round table B section.
  • the role of the segment A of the cylinder is mainly fixed; the main function of the segment B of the truncated cone is to cause directional extrusion on the vessel wall during the pressure expansion until it is restrained by the outer balloon.
  • the cylindrical A segment of the inner and outer layers is the same, and the pre-shaped volume of the inner balloon working B segment in the initial working state should be smaller than the outer balloon working B segment volume.
  • the truncated cone-shaped working B segment of the inner layer balloon is formed into a cone together with the second taper portion. shape.
  • the direction of the double-layered balloon on the catheter body is optional, the first tapered portion is oriented toward the connector, or the second tapered portion is oriented toward the connector.
  • the access holes on the outer balloon communication cavity are 2-4; the access holes on the inner balloon communication cavity are 2-6.
  • the developing ring is preferably two, respectively located at corresponding positions on both ends of the working section, and the working section refers to the working A section plus the working B section. To assist in positioning.
  • the following manner may be adopted: one is to connect a fixed balloon to the distal end of the double-layer balloon.
  • the other is to provide an outwardly protruding fixing structure in the cylindrical working A section of the outer balloon; further, the fixing structure is papillary and symmetrically distributed on the outer balloon.
  • the directional squeeze balloon dilatation catheter of the present invention can also provide 1 um-100 um micropores on the outer balloon wall, and the porosity is 5-90%.
  • the drug can be delivered through the outer balloon cavity and act on the wall through the micropores.
  • the directional squeeze balloon dilatation catheter of the present invention can be loaded with a drug on the outer balloon surface.
  • the compliance of the balloon refers to the extent to which the diameter of the balloon varies with the filling pressure of the balloon.
  • the formula says:
  • the double-layer balloon of the invention has inner and outer layers made of different compliant materials, the inner layer is of high compliance material, and is pre-shaped, the working section is cylindrical + round table shape, and the outer layer is non-compliant material.
  • the inner balloon expands axially due to the high compliance of the inner balloon, and the outer balloon is passively expanded, resulting in an axial compression effect of the balloon on the plaque.
  • the inner balloon wall slides relative to the outer balloon wall, while the outer balloon has less displacement relative to the plaque, so the outer balloon and the endocardium have less friction.
  • the balloon of this case has less damage to the endometrium during the expansion process.
  • the balloon body has a diameter of 1.0-20.0 mm after expansion and a length of 5 mm to 100 mm.
  • the working pressure of the balloon is 2-30 standard atmospheres.
  • the inner diameter of the guide wire lumen is from 0.1 mm to 1.5 mm.
  • the material of the balloon is a medical polymer material, which may be selected from the group consisting of: an alloy of cross-linked polyethylene and polyethylene terephthalate, polytetrafluoroethylene, nylon, polyurethane or other materials.
  • the balloon Before the balloon is used, the balloon is twitched and the double layer is closely attached and folded.
  • the balloon When used, the balloon as a whole spans the lesion, gradually increases the pressure of the inner balloon and reaches the named pressure.
  • the inner balloon and the first cone and the working segment A of the outer balloon expand synchronously, and the size and shape are equivalently named. And shape.
  • the inner and outer balloons continue to pressurize the inner balloon, the inner and outer balloons work in the B segment and gradually expand to form a cone Continuously applying pressure to the vessel wall in the direction of the shape, such that the balloon produces axially oriented compression of the vascular plaque, as shown in Figure 2; because the outer balloon is non-compliant, the size and shape of the inner balloon Limitation.
  • the balloon of the invention is combined with the distal protection device, the cutting balloon and the stent to achieve the expansion of the lumen and reduce the plaque volume effect.
  • the active filling of the outer balloon allows for a higher pressure expansion, including post-stent expansion.
  • the first to the second tapered portion of the balloon When the direction of the first to the second tapered portion of the balloon coincides with the direction of the distal end of the blood vessel, it is referred to as a forward-oriented expansion balloon; the first to the second tapered portion of the balloon is used. When the direction is opposite to the near distal direction of the blood vessel, it is called a reverse orientation expansion balloon.
  • the balloon described in the present invention can be loaded with a corresponding stent and subjected to the stent releasing operation.
  • the invention has the following beneficial effects:
  • the outer non-compliant balloon can be directly pressurized until the target is reached.
  • the outer balloon is loaded with drugs on the surface, and after the balloon is inflated, it closely adheres to the blood vessel wall to release the drug to the wall;
  • the outer balloon When the outer balloon is designed to have a microporous membrane, after the inner balloon is inflated, the outer balloon closely abuts the blood vessel wall, and can be administered through the outer balloon cavity and applied to the blood vessel wall.
  • Figure 1 is a schematic view of a conventional balloon angioplasty.
  • FIG. 2 is a schematic view showing the structure and operation of the directional squeeze balloon of the present invention.
  • A. Named pressure working state
  • B. During the inner layer balloon pressurization process,
  • C. is pressurized to a fully expanded state.
  • Figure 3 The outer segment of the balloon is a truncated catheter.
  • Figure 4 is a block diagram of the proximal midsection of the balloon dilatation catheter.
  • Figure 5 is a structural view of a balloon dilatation catheter. A: forward orienting the balloon, B: reverse orienting the balloon
  • Figure 6 Oriented balloon dilatation catheter with a papillary structure.
  • Figure 7 shows a directional balloon dilatation catheter with a fixed balloon at the distal end.
  • Figure 8 is a schematic view of the operation of the balloon dilatation catheter.
  • Figure 9 is a schematic illustration of a balloon dilatation catheter for the treatment of bifurcation lesions (Medina 010 or 001).
  • Figure 10 is a schematic illustration of a balloon dilatation catheter for the treatment of bifurcation lesions (Medina 100).
  • FIG. 5 is a structural view of a balloon dilatation catheter.
  • the directional squeeze balloon dilatation catheter comprises a coaxially connected guide wire tube 7, a catheter body 8 and a double-layer balloon 9 connected to the distal body of the catheter body, and the proximal body of the catheter body is provided with an external input port connection.
  • a developing ring 10 is provided in the balloon.
  • the double-layer balloon 9 can be designed in different directions on the catheter body, A: a forward-oriented balloon, and a B-orientation balloon.
  • the size of the balloon dilation catheter can be: L1:120-250cm, L2: 15-100cm, L3: 0.5-5.0cm, d: 1.25mm-8.0mm, d1: 0.6-1.5mm.
  • the double-layer balloon 9 is centered on the guide wire cavity and designed for the coaxial phase sleeve; the inner layer and the outer layer of the double-layer balloon are respectively sealed and connected with the catheter body; the inner layer balloon Highly compliant, pre-shaped into a first taper, a cylindrical working A segment, a frustum-shaped working B segment and a second taper; the outer balloon is non-compliant and has the same size and shape as the inner balloon The first taper and the cylindrical working section A, the truncated cone shaped working section B.
  • Figure 2 shows the A. named pressure working state, B. During the inner layer balloon pressurization, C. is pressurized to the fully expanded state.
  • the catheter used in this embodiment is a rapid balloon exchange catheter.
  • the catheter body comprises three independent cavities, and the central cavity is a guide wire lumen 6.
  • One end of the guide wire lumen 6 is connected to the guide wire tube, and the other end is open to the connection.
  • the two side cavities of the catheter body are the inner balloon communication chamber 3, the outer balloon communication chamber 4, and the inner balloon communication chamber 3 and the outer ball
  • One end of the bladder communication chamber 4 communicates with the connecting member, and the other end communicates with the inner layer balloon and the outer layer balloon through the inlet and outlet holes respectively;
  • the inlet and outlet holes on the outer balloon connecting chamber 4 are disposed in the inner layer balloon and the outer layer balloon
  • the inlet and outlet holes on the inner balloon communication chamber 3 are disposed in the inner layer balloon;
  • the connecting member has two independent ports, respectively, the connection port 1 of the inner balloon communication cavity and the connection port of the outer balloon communication cavity 1
  • Two-way rotary switches are respectively arranged on the two connection ports.
  • Fig. 6 is another fixing manner in which a fixing structure 11 which protrudes outward is provided in a cylindrical working A section region of the outer balloon.
  • Figure 7 is a perspective view of a balloon dilatation catheter of the present invention with a fixed balloon 12 attached to the distal end of the dual balloon 9.
  • a retractable distal protection device 13 is placed at the distal end of the lesion.
  • the stent is formed while extruding the plaque tissue
  • the use of the present invention provides a balloon for directional squeeze balloon angioplasty, and the plaque is extruded from the lesion to the distal end so as not to affect the branch opening, as shown in FIG.
  • Step 1 Directly squeezing the balloon 9 into position, with a distal end protection device 13 at its distal end, starting to expand with a named pressure;
  • Step 2 the directional squeeze balloon 9 is continuously pressurized to the target filling pressure
  • Step 3 After the directional squeeze balloon 9 is withdrawn, the extrudate is collected by the distal protection device 13.
  • the plaque is oriented from the distal end of the lesion toward the proximal end so as not to affect the branch opening, as shown in FIG.
  • Step 1 After the balloon is cut to cut the surface of the plaque, the balloon 9 is expanded in the opposite direction (the branch vessel 14 is expanded and expanded to prevent the plaque extrudate from entering the branch vessel);
  • Step 2 The directional squeeze balloon catheter is withdrawn (the intravascular balloon remains inflated, and the plaque extrudate is collected by the protective device 13 located at the distal end of the main branch vessel);
  • Step 3 Withdrawal of the intravascular device, depending on the condition of the vessel after the balloon has been dilated, it is decided whether to insert or not.

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Abstract

一种定向挤压球囊扩张导管，包括：导管体（8），连接在导管体（8）远端体部的双层球囊（9）以及导管体（8）近端体部的外源输入端口连接件。双层球囊（9）内设有显影环（10）。所述双层球囊（9）以导管体（8）为中心，内层球囊具有高顺应性，在命名压时其被预塑形为具有第一锥部、圆柱形工作A段、圆台形工作B段和第二锥部；外层球囊具有非顺应性。导管体（8）包含三个独立的腔，中心腔为导丝腔（6），两个侧腔为内球囊连通腔（3）和外球囊连通腔（4），所述内球囊连通腔（3）和外球囊连通腔（4）的一端分别与内外球囊连通，另一端与连接件相通。该定向挤压球囊扩张导管由于内外球囊具有不同的顺应性，工作时能够定向扩张，有效减少斑块体积，避免分支受累，最大限度保护了内皮组织。

Description

一种定向挤压球囊扩张导管 技术领域
本发明属于医疗器械领域，涉及一种介入医疗用的球囊扩张导管，具体是一种定向挤压球囊扩张导管。
背景技术
冠状动脉粥样硬化性心脏病是当今人类主要致死、致残性疾病。经皮血管腔内球囊成形术(PTCA)/支架术是其主要的治疗方法。这种经皮冠状动脉内干预术(PCI)疗效至今仍不甚满意。首先，PCI不能真正减少死亡和非致命心肌梗死，尤其在稳定性冠心病中和优化的药物治疗方案相比较时[1,2]；其次，不能长期缓解血管狭窄。6个月时单纯PTCA再狭窄率高达50％,裸金属支架再狭窄可达40％[3]。即便是采用第2代药物支架治疗，6年后较金属裸支架减少再狭窄的优势所剩无多[2]。故，PCI有需要持续改进的需求。
传统的PTCA使用半顺应或非顺应气囊进行血管病变部位扩张，管腔增大的原因为：斑块被径向压缩和管壁扩大(几乎各贡献50％[4])，伴斑块轴向移位[5]。混合性斑块或钙化斑块的管腔解剖增大的因素是斑块不规则撕裂和夹层形成[6]，如图1。这种扩张的后果是，破坏了病变原有完整性，斑块沿血管轴向迁移，不但容易引起边支受累，还使得致炎的脂质核成分影响范围被人为扩大，血管内膜受损，中膜断裂外膜张力性膨出，进而促发机体的增生修复反应。因此，在获得解剖意义上的管腔增加时，换来的是，血管机械性创伤，炎症扩散，斑块破裂移位。
组织学研究表明，因内皮受损、管壁物质的趋化作用，在PCI术后早期血管扩张区域即出现血小板激活、黏附，及附壁血栓形成；同时血管内膜出现大量的巨噬细胞和幼稚的平滑肌细胞浸润，这些细胞及其间质是新生内膜的主要构成成分[7]，正是这种过度增生的新生内膜导致了血管再狭窄。
由此可见，传统的血管内球囊成形术一方面没有真正减少动脉粥样硬化斑块体积，尤其是没有减少致炎的成分，另一方面，却导致了管壁炎症激活、扩展以及内膜完整性破坏，这是传统PCI获益受限的主要原因。如何减少粥样斑块的脂核负荷(致炎的主要成分)，并最大程度保护内皮层，是亟待解决的问题。
专利CN1010 45175A、CN103623497A和CN104857615A都公开了一种双层球囊，但所涉及的双层球囊，其使用目的仅仅是解决提供局部给药的路径和方法；不能解决粥样斑块的脂核负荷问题。
专利CN201394274Y和CN204395193所涉及双层球囊是为了解决单层球囊可能破裂的 问题，内外层球囊材质、形状一致；不能解决粥样斑块的脂核负荷问题并保护内皮层。
专利CN201135683[P]和CN105662668A提供的是一种单层锥形球囊，用于管径落差大的血管节段的病变扩张并改善通过性，但仍不能解决粥样斑块的脂核负荷问题并保护内皮层。
本发明受启发于临床脓肿的治疗方法。化脓性疾病一个显著特点是中央有个强致炎的囊性包裹区，外周是炎症细胞包绕的多层结构。脓肿最有效的治疗方法是切开引流，只有引流出脓肿核心方可痊愈。动脉粥样硬化性病灶与之类似，推测必须切开病灶并排掉脂质核物质，减少致炎作用，才可从根本上改善动脉粥样硬化性病变的预后。
既往有定向斑块旋切或旋磨技术，用于斑块减容术，这个技术被证明并不优于传统的PCI，可能与其造成血管损伤范围过大，内膜损伤过于严重有关。而内皮具有抗增生、抗血栓、促进损伤愈合作用[8]，故本发明提供的技术关键优势在于，在去除脂质核等病理组织同时最大程度保护了内皮组织。
参考文献
[1]Boden WE,O'Rourke RA,Teo KK,et al；COURAGE Trial Research Group.Optimal medical therapy with or without PCI for stable coronary disease.N Engl J Med.2007；356(15):1503-16.
[2]
Figure PCTCN2017094640-appb-000001
KH,Mannsverk J,Wiseth R,et al；NORSTENT Investigators.Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.N Engl J Med.2016；375(13):1242-52.
[3]Buccheri D,Piraino D,Andolina G,et al.Understanding and managing in-stent restenosis:a review of clinical data,from pathogenesis to treatment.J Thorac Dis.2016；8(10):E1150-62.
[4]Baptista J,Umans VA,di Mario C,et al.Mechanisms of luminal enlargement and quantification of vessel wall trauma following balloon coronary angioplasty and directional atherectomy.Eur Heart J.1995；16(11):1603-12.
[5]Mintz GS,Pichard AD,Kent KM,et al.Axial plaque redistribution as a mechanism of percutaneous transluminal coronary angioplasty.Am J Cardiol.1996；77(5):427-30.
[6]Ahmed JM1,Mintz GS,Weissman NJ,et al.Mechanism of lumen enlargement during intracoronary stent implantation:an intravascular ultrasound study.Circulation.2000；102(1):7-10.
[7]Komatsu R,Ueda M,Naruko T,et al.Neointimal tissue response at sites of coronary stenting in humans:macroscopic,histological,and immunohistochemical analyses.Circulation.1998；98(3):224-33.
[8]Noma K,Kihara Y,Higashi Y.Outstanding Effect of Physical Exercise on Endothelial Function Even in Children and Adolescents.Circ J.2017；81(5):637-639.
发明内容
为了解决粥样斑块的脂核负荷，并最大程度保护内皮层，本发明提供一种定向挤压球囊旨在通过球囊的定向扩张减少斑块体积，避免分支受累，最大限度保护内皮组织。
本发明解决上述问题所采取的技术方案是：
一种定向挤压球囊扩张导管，一种定向挤压球囊扩张导管，包括导管体和连接在导管体远端体部的双层球囊，导管体近端体部设有外源输入端口连接件，球囊内设有显影环；所述双层球囊以导管体为中心，为同轴相套设计；双层球囊的内层和外层的两端部分别与导管体密封连接；内层球囊具有高顺应性，在初始工作状态也即命名压时，预塑形为第一锥部、圆柱形工作A段、圆台形工作B段和第二锥部；外层球囊具有非顺应性；导管体包含3个独立的腔，中心腔为导丝腔，导管体的二个侧腔为内球囊连通腔、外球囊连通腔，所述内球囊连通腔与外球囊连通腔的一端与连接件相通，另一端通过进出孔分别与内层球囊和外层球囊相通；外球囊连通腔上的进出孔设置于内层球囊和外层球囊之间；内球囊连通腔上的进出孔设置于内层球囊内。
本发明的关键在于定向挤压球囊的设计，对于导管系统没有限制，可以是快速交换球囊导管或同轴交换球囊导管。如本领域技术人员所知晓的，如果导丝出口在球囊扩张导管中间段(连接件与球囊之间的导管体体部)，称为快速交换球囊导管；如果导丝出口在连接件的端，称为同轴交换球囊导管(on-the-wire)。
本发明中，导丝腔一端与导丝管相连，另一端开口于导丝出口，所述导丝出口位于连接件与球囊之间的导管体体部或者位于外源输入端口连接件。
当采用快速交换球囊导管形式时，所述连接件具有两个独立端口，分别为内、外球囊连通腔的连接口；两个连接口分别设置有双向旋转开关。当采用同轴交换球囊导管形式时，所述连接件可以具有3个独立端口，分别与导管体的3个腔连通。
本发明中，外层球囊具有非顺应性，其工作段形状为常规的，例如可根据血管管径的特点设计为圆柱形或圆台形(图3)结构，其加压充盈时包括第一锥部、圆柱形工作A段和圆柱形或圆台形B段、第二锥部。由于其非顺应性，在形状上构成对内层球囊膨胀的限制。外层球囊的圆柱形工作A段和B段位置对应于内层球囊的圆柱形工作A段和锥台形工作B段。
本发明中，内层球囊具有顺应性，其工作段预塑形为圆柱A段+圆台B段。工作时，圆柱A段的作用主要是固定；圆台B段的主要作用是在加压膨胀直至被外层球囊限制过程中对血管壁产生定向挤压。可以理解，在初始工作状态时，内外层的圆柱A段即达到相同，而内层球囊工作B段在初始工作状态时的预塑形体积应当小于外层球囊工作B段体积。优选地，在初始工作状态也即命名压时，内层球囊预塑形的圆台形工作B段与第二锥部一同形成圆锥 形。
本发明中，所述双层球囊在导管体上的方向是可选的，第一锥部朝向连接件方向，或者是第二锥部朝向连接件方向。
本发明所述的定向挤压球囊扩张导管，所述外球囊连通腔上的进出孔为2-4个；所述内球囊连通腔上的进出孔为2-6个。
本发明中，所述显影环优选为两个，分别位于工作段两端相应位置，所述工作段是指工作A段加工作B段。以辅助定位。
对于本发明的定向挤压球囊扩张导管来说，为了便于固定，可采用以下方式：一种是在所述双层球囊的远端连接有固定球囊。另一种是在外层球囊的圆柱形工作A段区域设有向外突出的固定结构；进一步地，所述的固定结构为乳突状，在外层球囊上呈对称分布。
本发明的定向挤压球囊扩张导管，还可在外层球囊壁上设置1um-100um微孔，成孔率5-90％。内层球囊膨胀时可以经外层球囊腔输送药物，通过微孔作用于管壁。
本发明的定向挤压球囊扩张导管，可在其外层球囊表面装载药物。
球囊的顺应性，指球囊的直径随球囊充盈压力变化的程度。公式表示：
球囊的顺应性＝球囊额度压力下的直径/球囊命名压下的直径
球囊的顺应性为1.05-1.10时，称为非顺应性球囊；顺应性为1.18-1.30时，称为半顺应性球囊；顺应性超过1.30，为顺应性球囊，其体积变化范围在100-600％。
本发明中的双层球囊，其内、外层由不同顺应性材质制成，内层为高顺应性材质，并经过预塑形，工作段为圆柱+圆台形，外层为非顺应材质制成的传统球囊。内层球囊连续加压时，因为内层球囊的高顺应性，内层球囊轴向扩张，外层球囊被动扩张，结果球囊对斑块产生轴向挤压效应。此外，内层球囊在持续充盈过程中，内层球囊壁相对外层球囊壁滑动，而外层球囊相对斑块位移少，故外层球囊和血管内膜摩擦力小，如此，和传统球囊相比，本案球囊在扩张过程中对内膜损害较小。
本发明所述的球囊扩张导管，其中，优选地，所述球囊体扩张后的直径为1.0-20.0mm，长度为5mm—100mm。球囊体的工作压力为2-30个标准大气压。导丝腔的内径为0.1mm-1.5mm。
所述球囊的材质为医用高分子材料，可选为：交联聚乙烯和聚苯二甲酸乙二醇酯、聚四氟乙烯、尼龙、聚氨酯或其他材料的合金。
球囊使用前，球囊抽瘪双层紧密贴合并折叠。使用时，球囊整体跨越病变，逐渐增加内层球囊压力并达到命名压时，内层球囊与外层球囊的第一锥部和工作A段同步膨胀，大小和形状等同命名的大小和形状。继续加压内层球囊，内、外层球囊工作B段逐渐膨胀，形成锥 形方向上对血管壁连续施压，如此球囊对血管斑块产生轴向定向挤压作用，如图2所示；因为外层球囊具有非顺应性，对内层球囊的大小、形状起限制作用。本发明球囊和远端保护装置、切割球囊及支架等配合使用，达到扩张管腔，减少斑块容积效果。此外，主动充盈外层球囊可以行更高压力扩张，包括支架后扩张。
该球囊使用时的第一锥部至第二锥部的方向与血管近远端方向一致时，称为正向定向扩张球囊；该球囊使用时的第一锥部至第二锥部的方向与血管近远端方向相反时，称为反向定向扩张球囊。
本发明中所述的球囊可装载相应支架，并进行所述支架释放操作。
本发明与现有技术相比，具有以下有益效果：
1)与切割球囊、远端保护装置配合使用时，通过挤压发挥斑块减容效应，这种作用改变了传统的血管腔内球囊成形术(PTCA)/支架术的机制。
2)处理分叉病变时，定向推移和减容斑块，不易影响分支。
3)当仅充盈内层球囊时不能够充分扩张病变或支架时，可以直接加压外层非顺应球囊，直至达到目标。
4)还发挥药物球囊的作用：
(1)外层球囊表面装载药物，在球囊膨胀后与血管壁紧密贴合，将药物释放至管壁；
(2)当外层球囊设计为带微孔膜时，在内层球囊膨胀后，外层球囊紧密贴靠血管壁，可以经外层球囊腔给药，施于血管壁局部。
附图说明
图1是传统的球囊成形术示意图。
图2是本发明定向挤压球囊的结构和工作示意图；A.命名压工作状态，B.内层球囊加压过程中，C.加压至完全膨胀状态。
图3外层球囊工作B段为圆台形的扩张导管。
图4是球囊扩张导管近中段结构图。
图5是球囊扩张导管结构图。A：正向定向球囊，B：反向定向球囊
图6带有乳突状结构的定向球囊扩张导管。
图7远端带有固定球囊的定向球囊扩张导管。
图8球囊扩张导管工作示意图。
图9是球囊扩张导管用于治疗分叉病变(Medina010或001)示意图。
图10是球囊扩张导管用于治疗分叉病变(Medina100)示意图。
具体实施方式
实施例1
图5是球囊扩张导管结构图。定向挤压球囊扩张导管，包括同轴相连的导丝管7、导管体8和连接在导管体远端体部的双层球囊9，导管体近端体部设有外源输入端口连接件，球囊内设有显影环10。双层球囊9在导管体上可以设计为不同方向，A：正向定向球囊，B：反向定向球囊。做为一个实例，该球囊扩张导管的尺寸可以是：L1：120-250cm，L2:15-100cm，L3:0.5—5.0cm，d:1.25mm—8.0mm，d1：0.6—1.5mm。
如图2A，所述双层球囊9以导丝腔为中心，为同轴相套设计；双层球囊的内层和外层的两端部分别与导管体密封连接；内层球囊具有高顺应性，预塑形为第一锥部、圆柱形工作A段、锥台形工作B段和第二锥部；外层球囊具有非顺应性，有与内层球囊同样大小、形状的第一锥部和圆柱形工作A段，圆台形工作B段。图2显示了A.命名压工作状态，B.内层球囊加压过程中，C.加压至完全膨胀状态。
本实施例采用的导管为快速球囊交换导管，如图4，导管体包含3个独立的腔，中心腔为导丝腔6，导丝腔6一端与导丝管相连，另一端开口于连接件与球囊之间的导管体体部的导丝出口5；导管体的二个侧腔为内球囊连通腔3、外球囊连通腔4，所述内球囊连通腔3与外球囊连通腔4的一端与连接件相通，另一端通过进出孔分别与内层球囊和外层球囊相通；外球囊连通腔4上的进出孔设置于内层球囊和外层球囊之间；内球囊连通腔3上的进出孔设置于内层球囊内；连接件具有两个独立端口，分别为内球囊连通腔的连接口1和外球囊连通腔的连接口1；两个连接口上分别设置有双向旋转开关。
图6是另一种固定方式，是在外层球囊的圆柱形工作A段区域设有向外突出的固定结构11。
图7是本发明球囊扩张导管的一种固定方式，双层球囊9的远端连接有固定球囊12。
实施例2
举例说明本发明球囊导管使用的3种情况
1、一个动脉粥样硬化病灶的减容治疗方法，如图8：
1)在常规的介入操作基础上，于病变远端安置一个可回收的远端保护装置13
2)使用切割球囊切割斑块
3)再使用本发明提供的定向挤压气囊9，将斑块组织的内部成分定向挤出斑块
4)如需更高压力扩张，主动充盈外层球囊至更高压力
5)或使用本发明提供的定向挤压气囊所装载的支架，在挤出斑块组织的同时给予支架成形术
6)回收远端保护装置，将斑块挤出的成分取出体外。
2、分叉病变(Medina010或001)的处理
使用本发明提供球囊施行定向挤压球囊扩张成形术，自病变向远端定向挤压斑块，使不影响分支开口，如图9。
步骤1：定向挤压球囊9到位，其远端有远端保护装置13，以命名压开始扩张；
步骤2：定向挤压球囊9持续加压至目标充盈压；
步骤3：定向挤压球囊9撤出后，挤压物被远端保护装置13收集。
3、分叉病变(Medina100)的处理
使用本发明提供球囊施行定向挤压球囊扩张成形术，自病变的远端朝着近端定向挤压斑块，使不影响分支开口，如图10。
步骤1：切割球囊切割斑块表面后，反向定向挤压球囊9扩张(分支血管内置球囊14并膨胀，防止斑块挤出物进入分支血管)；
步骤2：定向挤压球囊导管撤出(分支血管内球囊保持膨胀，斑块挤出物被置于主支血管远端的保护装置13收集)；
步骤3：撤出血管内装置，根据定向球囊扩张后的血管情况，决定置入或不置入支架。

Claims (10)

  1. 一种定向挤压球囊扩张导管，包括导管体和连接在导管体远端体部的双层球囊，导管体近端体部设有外源输入端口连接件，球囊内设有显影环；其特征在于，所述双层球囊以导管体为中心，为同轴相套设计；双层球囊的内层和外层的两端部分别与导管体密封连接；内层球囊具有高顺应性，在命名压时，预塑形为第一锥部、圆柱形工作A段、圆台形工作B段和第二锥部；外层球囊具有非顺应性；导管体包含3个独立的腔，中心腔为导丝腔，导管体的二个侧腔为内球囊连通腔、外球囊连通腔，所述内球囊连通腔与外球囊连通腔的一端与连接件相通，另一端通过进出孔分别与内层球囊和外层球囊相通；外球囊连通腔上的进出孔设置于内层球囊和外层球囊之间；内球囊连通腔上的进出孔设置于内层球囊内。
  2. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述扩张导管是快速交换球囊导管或同轴交换球囊导管。
  3. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述连接件具有两个独立端口，分别为内、外球囊连通腔的连接口；两个连接口分别设置有双向旋转开关。
  4. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述双层球囊在导管体上的方向是可选的，第一锥部朝向连接件方向，或者是第二锥部朝向连接件方向。
  5. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述外球囊连通腔上的进出孔为2-4个；所述内球囊连通腔上的进出孔为2-6个。
  6. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述显影环为两个，分别位于工作段两端相应位置，所述工作段是指工作A段加工作B段。
  7. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，所述双层球囊的远端连接有固定球囊和/或在外层球囊的圆柱形工作A段区域设有向外突出的固定结构。
  8. 根据权利要求7所述的定向挤压球囊扩张导管，其特征在于，所述的固定结构为乳突状，在外层球囊上呈对称分布。
  9. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，外层球囊壁上设置1um-100um微孔，成孔率5-90％。
  10. 根据权利要求1所述的定向挤压球囊扩张导管，其特征在于，外层球囊表面装载药物。
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