CN101516291B - Bioabsorbable polymeric medical device - Google Patents

Bioabsorbable polymeric medical device Download PDF

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CN101516291B
CN101516291B CN 200780034691 CN200780034691A CN101516291B CN 101516291 B CN101516291 B CN 101516291B CN 200780034691 CN200780034691 CN 200780034691 CN 200780034691 A CN200780034691 A CN 200780034691A CN 101516291 B CN101516291 B CN 101516291B
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stent
member
structure
tube
multi
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CN 200780034691
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CN101516291A (en
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R·J·科顿
S·叶
J·帕齐恩扎
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奥巴斯尼茨医学公司
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Priority to US60/807,932 priority
Priority to US60/862,433 priority
Priority to US60/862,409 priority
Priority to US86243306P priority
Priority to US86240906P priority
Priority to US91326407P priority
Priority to US60/913,264 priority
Application filed by 奥巴斯尼茨医学公司 filed Critical 奥巴斯尼茨医学公司
Priority to PCT/US2007/074052 priority patent/WO2008011614A2/en
Priority claimed from CN201310312417.7A external-priority patent/CN103494661B/en
Publication of CN101516291A publication Critical patent/CN101516291A/en
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Abstract

在实施方案中描述了这样一种管状可锁定且可膨胀的可生物吸收的心血管支架,其具有低免疫原性且由可结晶的可生物吸收聚合物组合物或共混物制备。 Describes a tubular expandable locking and cardiovascular stents may in embodiments bioabsorbable, it has a low immunogenicity and preparation of the polymer composition or a blend of a crystallizable bioabsorbable.

Description

可生物吸收的聚合物医疗器械 Bioabsorbable polymeric medical

[0001] 相关申请的互相参引 [0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 本申请要求享有2007年4月20日提交的美国临时申请60/913,264、2006年10月20日提交的60/862,433以及2006年7月20日提交的60/807,932的优先权。 [0002] This application claims the benefit of United States April 20, 2007 Provisional Application 60 / 913,264, 60 / 862,433 and 60/807, 2006 July 20, 2006 filed on October 20 submitted 932 priority.

[0003] 本说明书中所引用的参考文献以及它们的参考文献,当适用于教导其它的或备选的详情、特征和/或技术背景时,通过引证的方式全文纳入本说明书中。 [0003] References cited in this specification, and their references, when to the teachings of additional or alternative details, features and / or technical background, incorporated by reference in its entirety in the present specification.

技术领域 FIELD

[0004] 本发明涉及用于植入体内腔结构的聚合物医疗器械。 [0004] The present invention relates to polymeric medical devices for implantation in the body cavity structure. 具体而言,该医疗器械包括这样一种聚合物结构,该聚合物为可生物吸收的、生物相容的并且其结构配置成与体内腔结构(例如血管)内部吻合。 Specifically, the medical device comprising a polymer structure, the polymer is bioabsorbable, biocompatible and which is consistent with the structure configured as an internal lumen structure (e.g., a blood vessel). 该医疗器械可用于治疗疾病,例如动脉粥样硬化、再狭窄和其它类型的小管阻塞。 The medical device can be used to treat diseases such as atherosclerosis, restenosis and other types of small duct obstruction.

背景技术 Background technique

[0005] 本发明实施方案中公开了一种新的医疗器械,例如一种具有一个或多个曲折结构实体的可膨胀的管状心血管支架。 [0005] The embodiments of the present invention discloses a new medical device, such as one having one or more inflatable tubular structural entity meandering cardiovascular stent. 所述新的医疗器械在其末端可包括一种封闭机构以确保该器械在载体装置上处于卷曲位置,以用于展开。 The new medical device at its closed end may include one mechanism to ensure that the instrument is crimped position on the carrier means for deployment. 该封闭机构提供了确保卷曲支架位于托架组件上的结构装置,从而使所述支架在插入以及送达治疗目标区域的过程中保持于固定位置。 The closing mechanism provides a means to ensure that the structure of crimped stent positioned on the carriage assembly such that the stent held in a fixed position during the insertion and delivery of the therapeutic target area. 该支架的锁定限制可一直维持到该器械植入或者除非其被该载体组件的膨胀结构克服。 The locking bracket may be restricted to the device is implanted maintained unless it is overcome or expanded configuration of the carrier assembly.

[0006] 发现使用金属支撑管(stenting)进行治疗(例如治疗血管闭塞)中一个长期的问题是当在血管受损位点处插入该器械后在该器械四周形成瘢痕组织,即所谓的再狭窄过程。 [0006] found that the use of a metal support tube (stenting) treatment (e.g., treatment of vascular occlusion) in a long-term problem is that when the damaged blood vessel at the site of the instrument is inserted into the instrument in the formation of scar tissue around the so-called restenosis process. 很多人认为存在形成支撑管血栓的持续风险,这是由于单独的或者含有药物包衣组合物的血管内金属支撑管的持久存在造成的,该疗法意欲避免所述损害。 Many people think that the presence of the support tube form a continuous risk of thrombosis, which is due alone or in the presence of persistent intravascular drug coating compositions caused by the metal support tube, the therapy is intended to avoid the damage. 此外,金属的或非可吸收的聚合物支撑管会阻止血管管腔`重塑和扩张。 Further, the polymer or non-resorbable metal support tube prevents the expansion of the vessel lumen and remodeling '.

[0007] 已知任何对身体组织或器官的损伤都经历伤口愈合过程,所述过程包括例如I型胶原合成和具体而言,平滑肌细胞从血管迁移,其导致了愈合区域的伴行性硬化和血管直径的再变窄。 [0007] Known any damage to the body tissues or organs are subjected to the wound healing process, the process comprising, for example, type I collagen synthesis, and specifically, from the vascular smooth muscle cell migration, which results in concomitant curing and healing area re-narrowing of the blood vessel diameter. 因此,通过手术将医疗器械例如支架植入血管所进行的侵入性操作,应需要支架具有足够可塑性以避免在支架膨胀以及在治疗区域中安置支架期间的血管壁挫伤或毛细血管损伤。 Thus, for example, medical devices surgically invasive procedures performed Stent implantation, the stent should have sufficient plasticity required to avoid expansion of the stent and the vessel wall during the placement of a stent in the treatment of contusion injury or capillary region.

[0008] 避免再狭窄的另一个长期目标为用没有免疫原性或免疫原性基本上很低的医疗器械进行手术操作。 [0008] prevent restenosis with other long-term goals immunogenic or non-immunogenic substantially low operative medical devices.

[0009] 植入后由于金属支撑管的持久存在造成形成支架血栓的持续风险,该风险尚未通过使用为避免所述问题产生的药物组合物包被金属结构的手段克服。 After [0009] Because of the persistence of the implant caused by the metal support tube form a continuous risk of stent thrombosis, yet to avoid the risk of the pharmaceutical composition of the package problems are overcome by using a means of the metal structure. 相反,这些包衣所导致的死亡率极高。 Instead, these coatings caused high mortality rate. 此外,金属的或聚合物的非可吸收支撑管会阻止血管管腔重塑和扩张。 In addition, metallic or non-absorbable polymer support tube prevents the expansion of the vessel lumen and remodeling. 已尝试多种方法来避免或愈合组织以及降低免疫反应的补体激活或血小板聚集。 Various methods have been tried to avoid or tissue healing and reduce complement activation of the immune response or platelet aggregation. 而且,需要消除或降低在植入位点处的炎症应答并降低植入物和/或其组分材料分解时创伤的可能。 Further, it is necessary to eliminate or reduce the response and reduce the likelihood of trauma or during and / decomposition of the component materials implant inflammation at the implant site. 发现最期望的改善目标为需要提高用于植入一特别是植入血管中一的医疗器械的形状和结构的柔性。 It found that the most desirable targets for improvement is needed to improve implant for implantation into a particular shape and configuration of a blood vessel a flexible medical device.

[0010] 参引文献 [0010] Literature references

[0011] 参引2003年8月19日授权的美国专利6,607,548 B2 (Inion),该文献公开了使用一种基于乳酸或乙醇酸的聚合物或共聚物与一种或多种共聚物添加剂共混而制得的生物相容性生物再吸收材料的组合物。 [0011] reference in authorizing August 19, 2003 U.S. Patent No. 6,607,548 B2 (Inion), which discloses the use of polymers or copolymers based on lactic or glycolic acid with one or more comonomers additive blends prepared biocompatible bioresorbable material composition. 该参考文献公开了由这些材料制得的植入物为可冷弯曲的且无裂纹或破裂。 This reference discloses materials prepared from these implants to be cold curved and no crack or breakage. EP 0401844公开了一种聚L-丙交酯与聚D-DL-丙交酯的共混物。 EP 0401844 discloses a poly-L- lactide and poly-D-DL- lactide blend. 美国专利6,001,395公开了生物可降解聚(L-丙交酯)或者其共聚物或共混物的片状粒子一至少部分为晶体——的药物递送。 U.S. Patent No. 6,001,395 discloses a biodegradable poly (L- lactide) or copolymers flake particles or a blend of at least partially crystalline - drug delivery. 美国专利7,070,607公开了一种动脉瘤修复线圈,其包括一种载有栓塞剂的可生物吸收的聚合物材料,其中血栓形成由聚合物组分控制。 U.S. Patent No. 7,070,607 discloses a coil aneurysm repair, which comprises one polymeric carrier material with a bioabsorbable embolic agent, wherein the polymer component is controlled by thrombosis.

发明内容 SUMMARY

[0012] 本发明发明人尤其已认识到需要改进植入物构型,包括体内应用的支架/支撑管构型。 [0012] In particular, the present inventors have recognized the need to improve implant configurations including stent application in vivo / support tube configuration. 发明人还认识到需要开发一种用于植入物(例如支撑管和血管合成移植物)的生物相容性聚合物共混物,从而在当该医疗器械用于体内时向基质聚合物提供了一种韧化机制。 The inventors have also recognized the need to develop an implant (e.g. a support tube and a synthetic vascular graft) biocompatible polymer blend is used, so that when the medical device is used to provide the matrix polymer in vivo a toughening mechanism. 他们假设该韧化机制可通过将额外的分子自由体积赋予基质聚合物以促进足够的分子运动来使得在生理条件下——尤其是当将另外的分子作用力施加于植入物上时——发生重结晶而被实施。 They assumed that the toughening mechanisms may impart additional molecular free volume of the polymer matrix to facilitate sufficient molecular motion such that under physiological conditions by - particularly when additional force is applied to the molecules on the implant - recrystallize be implemented. 他们已建立理论认为,提高的分子自由体积也可提高水吸收的速率从而增加塑化效果以及提高本体降解动力学。 They have theorized that a higher molecular free volume rate of water absorption can be improved thus increasing the plasticizing effect and increased bulk degradation kinetics.

[0013] 例如,该医疗器械可包括这样一种具有低免疫排斥性能的聚合物,例如一种可生物吸收的聚合物组合物或共混物,其具有平衡了弹性、刚性和柔性的混合机械性能。 [0013] For example, the medical device may comprise a polymer having low immune rejection performance, for example, an bioabsorbable polymer composition or blend having balanced flexibility, rigid and flexible mechanical mixing performance. 该聚合物组合物可通过可生物吸收的基质材料以及一种共聚物或三聚物添加剂而产生低的抗原性,所述基质材料的非限制性实例为可生物吸收的聚合物、共聚物或三聚物。 The polymer compositions can be produced by low antigenicity bioabsorbable matrix material may be a copolymer or a terpolymer and an additive, said polymeric matrix material, non-limiting examples of bioabsorbable copolymer or trimer. 这些类型的聚合物结构可有利地在体内进行酶促降解和吸收。 These types of polymer structures may advantageously be enzymatically degraded and absorbed in vivo. 特别是,该新的组合物可在体内进行“软”降解机制,该机制缓慢进行以使得降解产物或聚合物组分对周围组织损伤较小并从而降低再狭窄反应或完全抑制再狭窄。 In particular, the new composition may be "soft" in vivo degradation mechanisms, the mechanism slowly so that the degradation products of the polymer components or to less damage to surrounding tissue and thereby reduce the reaction restenosis or complete inhibition of restenosis.

[0014] 本发明的发明人还提出这样的新设计,该设计可使用所述可生物吸收的生物相容性可生物降解的材料以制造有利的支架,所述支架可向例如心血管体系提供非常适于在搏动运动、收缩和舒张中植入的柔性和延伸性。 [0014] The present invention also provides such new design, the design may use the bioabsorbable biocompatible biodegradable materials to produce advantageously a bracket may be provided to the cardiovascular system, e.g. very suitable for implantation in the beating movement, contraction and relaxation of the flexible and extensible.

[0015] 本文所公开的实施方案包括医疗器械,例如支撑管、合成移植物和导管,其可包括或可不包括一种植入患者体内的可生物吸收聚合物组合物。 [0015] The embodiments disclosed herein include medical devices, such as a support tube, synthetic grafts and conduits, which may or may not include an implant patient bioabsorbable polymer compositions.

[0016] 在一个实施方案中,提供了一种管状可膨胀的心血管支架(例如一种支撑管),其在植入后具有低排斥反应或免疫原作用,其由可生物吸收聚合物组合物或共混物制备而成,该组合物或共混物具有平衡了弹性、刚性和柔性的混合机械性能,这些性能使得支架管弯曲和卷曲在用于血管植入的可膨胀递送系统上。 [0016] In one embodiment, there is provided an expandable tubular cardiovascular stents (e.g. for supporting a pipe), which has a low rejection or immunogenic effect after implantation, which is a combination of a bioabsorbable polymer or prepared from a blend, the composition or blend having balanced flexibility, rigid and flexible mechanical mixing properties that is bent such that the stent is crimped onto the expandable and delivery system for implantation in a blood vessel. 该器械可用于治疗例如血管疾病(如动脉粥样硬化和再狭窄),并且可以一种可卷曲和/或可膨胀的结构提供,这些结构可与气囊血管成形术一起使用。 The instrument may be used, for example, the treatment of vascular disease (such as atherosclerosis and restenosis), and may be an curl and / or structure to provide expandable, these structures can be used with balloon angioplasty.

[0017] 在一个实施方案中,医疗器械可以一种可膨胀支架的形式提供,该可膨胀支架包括多种曲折支柱部件或结构从而形成一种坚固的结构,例如沿着式样重复的器械的圆周的环状结构(例如对于支架而言,非限制性地为遍及该结构、仅在开口端或其结合)。 [0017] In one embodiment, the medical device can be in the form of an expandable stent provided, the expandable stent comprises a plurality of meandering strut members or structures to form a robust structure, such as repeated pattern along the circumference of the instrument the cyclic structure (e.g., for purposes of the stent, without limitation to this configuration throughout, only the open end or a combination thereof). 曲折支柱结构可彼此相邻和/或以相反方向安置从而使得它们沿该器械纵轴在该可膨胀支架的长方向上整体径向且均一地膨胀。 Meandering strut structure may be adjacent to each other and / or in opposite directions so that they are arranged along the entire longitudinal axis of the instrument expands radially and uniformly in the longitudinal direction of the expandable stent. 在一个实施方案中,该可膨胀支架可包括任选具有侧面分枝的特定式样,例如具有均匀框架的格栅结构、双螺旋结构。 In one embodiment, the expandable stent may optionally comprise a particular pattern having a side branch, for example, a uniform grid structure frame, double helix.

[0018] 在一个实施方案中,可生物吸收的柔性支架以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可由未膨胀结构膨胀为一种膨胀结构,并且可弯曲;所述具有以膨胀形式存在的式样形状的支架包括: [0018] In one embodiment, bioresorbable flexible stent circumferentially about the longitudinal axis is formed in the form of a tube, the tube having a proximal open end and a distal open end, and may be expanded into a structure of unexpanded expandable structure, and bendable; having the pattern shape present in the form of expandable stent comprising:

[0019] a)多个第一曲折支柱单元结构(pattern),各第一曲折支柱单元结构彼此连接,从而以圆周形式绕纵轴形成一种相互连接的筛网样式;以及 [0019] a) a first plurality of meandering struts cell structure (pattern), each of the first meandering strut unit structures to each other, so that the form of the circumference around the longitudinal axis is formed in a mesh pattern of mutual connection; and

[0020] b)至少两个被套入相互连接的筛网样式内部的第二支柱单元结构,各所述第二支柱单元结构包括以圆周形式绕纵轴形成的箍,所述箍具有最接近纵轴的内表面和位于纵轴远端的外表面,沿圆周的箍内外表面与纵轴垂直并且基本位于同一平面内。 [0020] b) a second strut screen pattern cell structure within the at least two interconnected into a quilt, each of the second leg unit comprises a structure formed about a longitudinal axis form a circumferential hoop, said hoop having a longitudinal closest located on the inner surface of the shaft and the longitudinal axis of the distal end of the outer surface of the ferrule along the circumference of the inner and outer surfaces and substantially perpendicular to the longitudinal axis in the same plane.

[0021] 在一个实施方案中,第一曲折支柱单兀结构一般平行于所述纵轴、一般与所述纵轴斜交、一般与所述纵轴垂直或者一般环绕所述纵轴与其同轴。 [0021] In one embodiment, the first meandering strut Wu single structure generally parallel to said longitudinal axis, generally oblique to the longitudinal axis, or generally perpendicular to said longitudinal axis generally coaxial with the longitudinal axis surrounds . 第二支柱单元结构可由一种材料制备,其当所述管处于膨胀状态时基本上结晶,但在非膨胀状态时基本上不结晶。 The second pillar structure of a unit material may be prepared, when the tube is in its expanded state substantially crystalline, but substantially does not crystallize in the non-expanded state. 第二支柱单元结构可包括至少一个具有伸缩空隙(through-void)的箍,其中所述伸缩空隙被配置成能容纳当所述至少一个箍受到扩张作用力而扩张时的半径,该作用力超过其标称的膨胀状态但不导致箍被破坏。 The second pillar may comprise at least one cell structure has a telescopic gap (through-void) of the ferrule, wherein the gap is configured to be telescopically received when the at least one expandable cuff biasing force by the radius of the expansion, the biasing force exceeds its nominal expanded state, but does not result in destruction cuff.

[0022] 在一个实施方案中,该支架的各第一曲折支柱单元结构基本呈正弦曲线,各第二支柱单元结构基本呈非正弦曲线。 [0022] In one embodiment, each of the first meandering strut of the stent cell structure is substantially sinusoidal, the second leg of each unit structure substantially non-sinusoidal. 支架的各第一曲折支柱单元结构可由管的近开口端延伸到其远开口端。 Each of the first meandering strut structure of the stent by means of the proximal open end of the tube extends into the distal open end thereof. 在另一个实施方案中,各第二支柱单元结构可存在于近开口端和远开口端。 In another embodiment, each of the second unit structure may be present in strut near the opening end and a distal open end. 在一个实施方案中,各第二支柱单元结构还存在于近开口端和远开口端之间。 In one embodiment, each of the second leg unit structure further present between the distal end and the open proximal open end.

[0023] 在一个实施方案中,该支架可包括这样一个结构,其中各第二支柱单元结构可存在于近开口端和远开口端之间但并不位于近开口端和远开口端。 [0023] In one embodiment, the stent may include a structure in which each of the second unit structure may be present in strut near the opening end and a distal open end, but is not located between the proximal open end and a distal open end. 在另一个实施方案中,该支架可包括这样一个结构,其中第二支柱单元结构可存在于近开口端或远开口端中的至少一个上。 In another embodiment, the stent may include a configuration in which the second pillar structure unit may be present on the at least one open end or near the distal open end.

[0024] 在一个具体实施方案中,该支架包括这样一个支撑管,其具有非膨胀构型和膨胀构型;一个外部管状表面和一个内部管状表面,所述支撑管包括:在非膨胀构型中具有显著起伏式样且在膨胀构型中基本无起伏式样的多个可生物降解的、成对的、分离的圆周带以及跨各对圆周带之间并与成对的带中的各个带上多个点连接的多个可生物降解的互相连接结构,上述可生物降解的、成对的、分离的圆周带的起伏在支架处于非膨胀状态下存在而在处于膨胀状态下被纳入基本为平面的环中。 [0024] In one particular embodiment, the stent includes a support tube, having a non-expanded configuration and an expanded configuration; a tubular outer surface and an inner tubular surface, said support tube comprising: a non-expanded configuration in having a plurality of biologically significant relief pattern in the expanded configuration and substantially no degradation undulating pattern, paired, separated between each pair of circumferential band and the circumferential band across the band and each of the pair of belt a plurality of interconnected biodegradable structure connecting a plurality of points, said biodegradable, paired circumferential band of the separated stent undulations in the presence of a non-expanded state is included in the expanded state is substantially planar in the ring.

[0025] 在一个实施方案中,该支撑管互连结构包括非膨胀和膨胀二种构型时的起伏式样。 [0025] In one embodiment, the interconnect structure comprises a support tube of non-expandable and expandable undulating pattern when two kinds of configuration. 在另一个实施方案中,该互连结构包括这样一种式样,其中该式样在非膨胀和膨胀二种构型时都不包括含起伏的式样。 In another embodiment, the interconnect structure comprising a pattern, wherein the pattern in the non-expanded and expanded when the two kinds of configurations including not containing undulating pattern. 该支撑管的相互连接结构可在成对的圆周带的起伏之间膨胀。 Interconnect structure of the support tube between the paired expandable undulating circumferential band.

[0026] 在一个实施方案中,多个成对的可生物降解的圆周带中的至少一条沿其外部管状表面包括不透射线材料,该不透射线材料可通过放射照相术、MRI或螺旋CT技术检测。 [0026] In one embodiment, a plurality of pairs of biodegradable circumferential band at least one radiopaque material comprises along its outer tubular surface, the radiopaque material can be obtained by radiographic, MRI or spiral CT technical testing. 或者,至少一个相互连接结构沿其管的外表面含有不透射线材料,该不透射线材料可通过放射照相术、MRI或螺旋CT技术检测。 Alternatively, the outer surface of at least one connecting to each other along the pipe structure comprises radiopaque material, the radiopaque material can be obtained by radiographic, MRI or spiral CT detected. 该不透射线材料可被置于各圆周带中之一的凹处中,或者置于相互连接结构中之一的凹处中。 The radiopaque material may be placed in the recess of each one of the circumferential band, placed in one or another recess in the connection structure. 在一个实施方案中,相互连接结构中的至少一个和圆周带中的至少一个沿外管状曲面包括不透射线材料,该不透射线材料可通过放射照相术、MRI或螺旋CT技术检测。 And at least one circumferential band along at least one outer surface of the tubular In one embodiment, the interconnect structure comprises radiopaque material, the radiopaque material can be obtained by radiographic, MRI or spiral CT detected.

[0027] 在另一个实施方案中,可生物吸收的柔性支架以圆周形式绕纵轴大致形成这样一种管,该管具有近开口端以及远开口端,并且可弯曲且可膨胀;并且在膨胀形式下包括: [0027] In another embodiment, bioresorbable flexible stent circumferentially around the longitudinal axis is formed substantially in the form of a tube, the tube having a proximal open end and a distal open end, and an expandable and bendable; and in its expanded under the form include:

[0028] a)位于以圆周形式绕纵轴的至少两个环,该环具有接近纵轴的内表面、远离纵轴的外表面、接近于近开口端的顶面以及接近于远开口端的底面,位于绕圆周的环内外表面与纵轴垂直并基本位于同一平面内,以及 [0028] a) positioned circumferentially about a longitudinal axis of the at least two form a ring having an inner surface close to the longitudinal axis, the longitudinal axis away from the outer surface, a top surface and a bottom surface near the distal open end near the proximal open end, ring located around the circumference of the inner and outer surfaces and substantially perpendicular to the longitudinal axis in the same plane, and

[0029] b)位于所述至少两个环之间并绕纵轴圆周的多个曲折支柱单元结构;所述多个曲折支柱单元结构与所述环连接于各环圆周上的至少两个连接点,并且该环圆周上的各连接点位于环顶面和环底面上;其中位于环上表面以上以及下表面以下的与任何具体环连接的各点是结构对称的。 [0029] b) said at least meandering struts and a plurality of unit structures around the longitudinal axis between the two circumferential rings; meandering strut of the plurality of cell structures and the ring is attached to the circumference of each ring is connected to at least two point, and the connection points on circumferentially located around the top surface and the bottom surface of the ring; wherein the ring is located on the surface of the above points and is connected to any particular surface of the ring is equal to or lower symmetrical structure.

[0030] 在一个实施方案中,该支架包括这样一种结构,其中位于环上表面以上和环下表面以下的环的连接点、曲折支柱单元结构一起形成一个固定的字母H构型。 [0030] In one embodiment, the stent comprising a structure in which the ring is located above the lower ring surface and the point of attachment below the surface of the ring, together form a fixed configuration of letter H meander pillar cell structure. 在另一个实施方案中,该支架可包括这样一种结构,其中在环的连接点处位于环上表面以上和环下表面以下的曲折支柱单元结构一起形成两个邻接的正弦曲线。 In another embodiment, the stent may comprise a structure in which the ring is located above the surface at the connection point of the ring and the lower ring meandering struts cell structure below the surface formed with two adjoining sinusoidal. 在另一个实施方案中,该支架可包括这样一种结构,其中在环的连接点处位于环上表面以上和环下表面以下的曲折支柱单元结构与连接该单元结构和环的相干结构一起形成两个正弦曲线。 In another embodiment, the stent may comprise a structure which together form a ring positioned at the connection point above the upper ring surface and the lower surface of meandering strut ring of the following structural units and the coherent structure of the cell structure and connections of the ring two sinusoidal. 在一个实施方案中,该环的连接点在各连接处具有2至6个曲折支柱单元结构连接。 In one embodiment, the point of attachment of the ring having 2-6 meandering strut units connected to each of the connection structure.

[0031] 在另一个实施方案中,可膨胀的可生物降解的管状支架包括多个可生物降解的第一曲折结构从而形成相互连接的网。 [0031] In another embodiment, the expandable tubular biodegradable stent comprising a first plurality of meander structure so as to form a biodegradable mesh interconnected. 该网绕纵轴沿圆周延伸;其中各可生物降解的第一曲折结构由外消旋聚合物制备,该外消旋聚合物在管状支架的膨胀作用力下结晶,并且还包括多个可生物降解的第二曲折结构,各第二曲折结构彼此分离且各自在一个平面内绕纵轴沿圆周延伸,该第二曲折结构被套入第一曲折结构中并与之互连。 The web extends circumferentially about the longitudinal axis; wherein each biodegradable meander structure made from a first polymer racemic, racemic crystallization of the polymer at the expansion force of the tubular stent, and further comprising a plurality of biologically degradation second meander structure, each of the second meander structure separated from each other and in a plane extending circumferentially around the longitudinal axis, the second meander structure into the first quilt meandering structure and interconnected therewith. 在该实施方案中,该支架的第一曲折结构一般平行于纵轴、一般与纵轴斜交、一般与纵轴垂直、或者一般环绕所述纵轴与其同轴。 In this embodiment, the first meander structure of the bracket generally parallel to the longitudinal axis, the longitudinal axis generally oblique, generally perpendicular to the longitudinal axis, or longitudinal axis generally surrounds the coaxial therewith. 第二曲折结构由这样一种材料制成,该材料在管处于其膨胀状态时结晶而在其非膨胀状态时基本上不结晶;并且第二曲折结构中的至少一个包括至少一个伸缩空隙,其中所述伸缩空隙被配置成允许第二部件伸展而该部件不被破坏。 A second meander structure made of a material, the material in the tube is in its expanded state substantially crystalline not crystallize in its non-expanded state; and a second meander structure comprises at least one of the at least one telescoping gap, wherein the gap is configured to allow the telescoping member extension and the second member is not destroyed.

[0032] 在一个实施方案中,第一曲折结构形成这样一种支柱单元结构,当该管为膨胀形式时其呈正弦曲线;第二曲折结构形成这样一种支柱单元结构,当该管为膨胀形式时其呈非正弦曲线。 [0032] In one embodiment, the first meander structure forms a pillar cell structure, when the tube is expanded in the form of sinusoidal thereof; a second meander structure formed pillar cell structure, when the tube is expanded which is non-sinusoidal curve form. 在该实施方案和其它实施方案中,第一曲折结构形成这样一种支柱单元结构,其由管的近开口端延伸至远开口端;第二曲折结构形成这样一种支柱单元结构,其存在于近开口端和远开口端处。 In this embodiment and other embodiments, a first structure is formed in such a meandering struts cell structure, which extends from the proximal open end of the tube to the distal open end; a second meander structure forms a pillar cell structure, which is present in the proximal open end and a distal open end. 第二曲折结构也可形成这样一种支柱单元结构,其还存在于近开口端和远开口端处之间;或者第二曲折结构形成这样一种单元结构,其存在于近开口端和远开口端之间但并不形成于近开口端或远开口端。 A second meander structure may also be formed in such a pillar cell structure, which is also present in the proximal open end and an opening between the distal end; a second meander structure or a cell structure is formed, which is present in the proximal open end and a distal opening formed between the end but not at the proximal open end or distal open end.

[0033] 在另一个实施方案中,一种制备管状支架的方法包括:制备一种外消旋聚-丙交酯混合物;制造一种外消旋聚-丙交酯混合物的可生物降解的聚合物管;激光切割该管至形成所述支架。 [0033] In another embodiment, a method of preparing a tubular stent comprising: preparing a poly rac - lactide mixture; rac producing a poly - lactide mixture biodegradable polymeric property management; laser cutting the tube to form the stent. 在该实施方案中,支架的制造可使用成型技术或挤出工艺进行,所述成型技术基本无溶剂。 In this embodiment, the stent may be manufactured using an extrusion molding technique or process is performed, the substantially solvent-free molding technology.

[0034] 还提供了这样一种制造管状支架的方法,其包括:共混这样一种含可结晶组合物的聚合物组合物,所述可结晶组合物包括与改性共聚物连接的聚L-丙交酯或聚D-丙交酯的基质聚合物,所述改性共聚物包括嵌段共聚物或嵌段无规共聚物形式的聚L(或D)-共-碳酸亚丙酯或者聚L(或D)-共-ε -己内酯,其中丙交酯链长足够长以便于发生交联部分结晶;使该聚合物组合物成型以使所述支架结构成形;以及切割该支架以形成所需支架式样。 [0034] further provided a method of manufacturing a tubular stent, comprising: blending a crystallizable polymer composition containing composition, said composition comprising a crystalline modified copolymer poly connected to L - lactide or poly-D- lactide matrix polymer, the modified block copolymer comprises a random copolymer or a block copolymer of poly L (or D) - co - propylene carbonate or poly L (or D) - co -ε - caprolactone, wherein the lactide chain length long enough to crystallize partially crosslinking occurs; the polymer composition is molded so that the molded support structure; and cutting the stent to form the desired stent pattern. 在该实施方案中,该共混组合物包括一种聚L-丙交酯和聚D-丙交酯的外消旋混合物。 In this embodiment, the blend composition comprises a poly-L- lactide and poly-D- lactide racemic mixture. 因此,由该方法制造的医疗器械例如支撑管,基本上由一种聚L和聚D-丙交酯的外消旋混合物组成。 Thus, the method for producing a medical device such as a support tube, consisting essentially of a poly L-lactide and poly-D- racemic mixtures thereof. 在该实施方案中,该支撑管可包括其它聚合物材料例如碳酸亚丙酯。 In this embodiment, the support tube may comprise other polymeric materials such as propylene carbonate. 在器械包括碳酸三甲酯的实施方案中,碳酸三甲酯的量不超过支架重量的40%以上。 In the embodiment of the instrument comprises trimethyl carbonate, the amount of trimethyl carbonate does not exceed more than 40% by weight of the stent.

[0035] 在另一个实施方案中,提供了这样一种可膨胀的管状支架,该支架具有绕纵轴限定的近端和远端。 [0035] In another embodiment, there is provided an expandable tubular stent, the stent having proximal and distal ends about the longitudinal axis defined. 该支架包括: The bracket includes:

[0036] (a)多个第一曲折支柱部件,该部件彼此相互连接于至少一个点处以形成一种圆周管状结构,该第一曲折支柱部件形成可弯曲且可膨胀的管状网; [0036] (a) a first plurality of meandering strut member, the member interconnected to one another at least one point to form a circumference of the tubular structure imposed, the first meandering strut member may be bent and formed expandable tubular mesh;

[0037] (b)第二曲折支柱部件,其有效地成形从而可卷曲且可膨胀并成形以在膨胀后形成支架的环状支柱;以及 [0037] (b) a second meandering strut member, which effectively crimps and can be shaped so as to be expanded and shaped to form an annular strut after expansion of the stent; and

[0038] (C)使得支架锁定于·卷曲位置的锁定装置; [0038] (C) so that the stent crimped-locked in the position of locking means;

[0039] 其中该支架包括膨胀可结晶的、可生物吸收外消旋聚合物组合物或共混物。 [0039] wherein the expandable stent comprises a crystallizable, racemates bioabsorbable polymer composition or blend.

[0040] 在一个锁的一种实施方案中,管状支架可包括这样一个结构,其中该锁定装置为一个两部分部件,其为位于或接近该管状支架的近端和远端的一个或不同的曲折支柱部件。 [0040] In one embodiment of a lock, it may include a tubular stent structure, wherein the locking means is a two-part member, which is at or near a proximal end and a distal end of the tubular stent or different meandering strut members. 在该实施方案中,该锁定装置的两部分部件可需要例如位于支架曲折位置的卡扣接合,其中该锁定工具通过支架膨胀而被分开。 In this embodiment, the two parts of the locking member, for example, may require the device located at the position of the stent twists snap engagement, wherein the locking means are separated by stent expansion. 在另一个实施方案中,管状支架可包括这样一个锁定装置,该锁定装置包括卡扣匙锁构型,其中该设计类似楔形榫头型联锁工具。 In another embodiment, the tubular stent may include a locking means, the locking means comprises a snap lock key configuration, wherein the design tool is similar to a dovetail-type interlocking. 该管状支架也可包括这些锁定装置,其包括类似于球窝接合型联锁装置的卡扣匙锁构型;钩住塑料支架的反向成形的末端部件的腕臂等。 The tubular stent may also comprise the locking means, which includes a key lock configuration similar to snap ball joint type interlocking means; cantilever end of the hooking member of the reverse molded plastic carrier and the like.

[0041] 管状支架可被设置于或负载于可膨胀气囊载体装置上,其尺寸可被设定为能够由卷曲管直径伸展至足以植入血管体系的内腔内的直径。 [0041] The tubular holder may be provided in or supported on the inflatable bladder carrier means, the size of which can be set so as to extend from the coiled tubing inner diameter to a diameter sufficient to implantation of the endovascular system.

[0042] 在另一个实施方案中,可膨胀支架包括一组联锁的曲折支柱,该支柱稳定处于膨胀或植入构型的植入支架,其中支架聚合物在膨胀的径向应变期间发生分子再定向和结晶。 [0042] In another embodiment, the expandable stent may comprise a set of interlocking meandering strut, the strut in the expanded stable configuration of the implant or a stent, wherein the stent during expansion of the polymer occurring molecules radial strain re-orientation and crystallinity. 该支架可由圆柱形变化为圆锥形或其组合。 The bracket may be changed to a cylindrical-conical, or combinations thereof. 在本文所述的各实施方案中,该支架的可生物降解聚合物表现出足够慢的降解动力学以避免组织过载或其它炎性反应。 In each of the embodiments described herein, the biodegradable polymer scaffold exhibits a slow enough to avoid degradation kinetics overload or other inflammatory tissue reaction. 聚合物核心材料包括至少一种用于血管壁和内腔的局部治疗的被包封药物。 Polymeric core material comprising at least one topical treatment for a blood vessel wall and lumen were encapsulated drug.

[0043] 该管状支架也可包括一种或多种药物物质,其可被包封于用于局部释放药物以及治疗和预防组织发炎和血小板聚集的聚合结构中。 [0043] The tubular stent may also include one or more drug substances which may be encapsulated in a polymeric structure as well as local delivery of drug treatment and prevention of tissue inflammation and aggregation of platelets. 该管状支架也可包括至少一种附着或包埋识别标志,其可为包括点不透射线或弥漫不透射线的附着或包埋的识别标记物。 The tubular stent may also comprise at least one attachment or embedding identification, which may include a radiopaque point or diffuse attached or embedded radiopaque marker line identification.

[0044] 该管状支架也可包括这样一些曲折支柱,其可通过包括选自一种或多种以下构型的小圈连接器互锁:H状、X状、穿孔圆形、两个相邻的H状、三个附着的连接、两个相邻平行连接、平行支柱的正弦连接。 [0044] The tubular stent may also include such meandering struts, which can comprise from one or more of the following configurations connector interlocking small circle: H-shaped, X-shaped, circular perforations, two adjacent the H-shaped, connecting the three attaching, connecting two adjacent parallel, sinusoidal struts connected in parallel.

[0045] 在另一个实施方案中,可生物吸收的柔性支架以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可弯曲和可膨胀;其包括: [0045] In another embodiment, bioresorbable flexible stent circumferentially about the longitudinal axis is formed in the form of a tube, the tube having a proximal end and a distal open end opening, and the expandable and bendable; comprising:

[0046] (a)多个第一曲折支柱部件,该部件彼此相互连接于至少一个点处以形成一种圆周管状结构,该第一曲折支柱部件形成可弯曲且可膨胀的管状网; [0046] (a) a first plurality of meandering strut member, the member interconnected to one another at least one point to form a circumference of the tubular structure imposed, the first meandering strut member may be bent and formed expandable tubular mesh;

[0047] (b)第二曲折支柱部件,其有效地成形从而可卷曲和可膨胀并成形以在膨胀后形成支架的箍状支柱,其中该箍状支柱具有接近纵轴的内表面、远离纵轴的外表面、接近于近开口端的顶面以及接近于远开口端的底面;第二曲折支柱部件与多个第一曲折支柱部件相互连接;以及 [0047] (b) a second meandering strut member, which effectively crimps and shaped so as to be expanded and shaped to be band-like struts formed after expansion of the stent, wherein the strut-like band having an inner surface close to the longitudinal axis, away from the longitudinal the outer surface of the shaft, close to the top surface and the bottom surface near the open end of the proximal open distal end; a plurality of second meandering strut member interconnecting the first meandering strut member; and

[0048] (C)位于接近于第二曲折支柱部件的内表面或外表面的至少一对锁定机构,该对锁定机构被成形以当支架处于非膨胀状态时彼此有效锁定,但在支架处于膨胀状态时彼此分离。 [0048] (C) is located close to the inner or outer surface of the second meandering strut member at least one locking mechanism, the locking mechanism is formed when the stent is in a non-expanded state effectively locked to each other, but in an expanded stent state separated from each other.

[0049] 该支架可包括这样一对锁定机构,其包括当支架处于非膨胀状态时彼此连接的腕臂;包括相对的凸凹连接器的锁定机构;这样一些锁定机构,其包括当该支架处于非膨胀状态时用易碎连接彼此邻接的连接器,但在该支架处于膨胀状态时易碎连接破裂时分离的连接器;包括楔形榫头型联锁连接器的锁定结构;这样一些锁定机构,其包括腕臂和当该支架处于非膨胀状态时的第二曲折支柱部件的部件,并且当该支架处于非膨胀状态时形成从第二曲折支柱部件开始延伸的腕臂和该部件中的凹处。 [0049] The bracket may include a pair of locking mechanism, which comprises as cantilever the stent is in a non-expanded state are connected to each other; comprising opposing punch and the connector locking mechanism; as locking mechanism including when the stent is non- expanded state adjacent connected to each other by frangible connector, but in the expanded state of the stent is separated at break frangible connection connector; locking structure comprising interlocking dovetail-type connector; as locking mechanism, comprising when the cantilever and the non-expanded state of the stent is a second meandering strut member member, and the cantilever is formed extending from the second member and the meandering strut member in the recess when the stent is in the unexpanded state. 所述管的锁定机构可被合适成形并安置以便于在非膨胀状态以及装在可膨胀气囊载体装置上时可以锁定。 The locking mechanism may be tube shaped and suitable to be positioned to and locked in the non-expanded state the expandable balloon is mounted on the carrier device.

[0050] 在另一个实施方案中,可卷曲的可生物吸收的柔性支架以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可由未膨胀结构膨胀为一种膨胀结构,并且含有锁定机构以将支架的一个部件锁定到另一个上,膨胀形式下具有式样形状的支架包括: [0050] In another embodiment, a rollable flexible bioabsorbable stent is formed circumferentially about a longitudinal axis in the form of a tube, the tube having a proximal open end and a distal open end, and may be expanded into an unexpanded configuration species expanded configuration, and comprising a locking mechanism to lock the bracket member to the other, the expanded form of stent patterns having a shape comprising:

[0051] (a)多个第一曲折支柱单元结构,各第一曲折支柱单元结构彼此相互连接从而以圆周形式绕纵轴形成一种相互连接的筛网式样;以及 [0051] (a) a first plurality of cell structures meandering struts, each meandering strut of the first structure are interconnected to each other so that cell circumferentially about the longitudinal axis in the form of a mesh pattern formed in a mutually connected; and

[0052] (b)至少两个被套入相互连接的筛网式样内部的第二支柱单元结构,各所述第二支柱单元结构包括以圆周形式绕纵轴形成的箍,所述箍具有最接近纵轴的内表面和位于纵轴远端的外表面,沿圆周的箍内外表面正交于纵轴并且基本位于同一平面内。 [0052] (b) a second strut element mesh structure inside the quilt pattern at least two interconnected, each of the second leg unit comprises a structure formed about a longitudinal axis form a circumferential hoop, said hoop having the closest the inner surface of the longitudinal axis and the longitudinal axis of the distal outer surface located along the inner and outer surfaces of the hoop circumferential substantially orthogonal to the longitudinal axis and in the same plane.

[0053] 该可膨胀管状支架包括一个或多个第一曲折结构,该第一曲折结构包括贮藏器(receptacle)结构以用于相应锁结构的锁合容纳。 [0053] The expandable tubular stent comprising a plurality of first or meandering structure, the meandering structure comprises a first receptacle (RECEPTACLE) corresponding lock structure for locking engagement receiving structure. 该可膨胀管状支架包括这样一种结构,其中该相应锁定机构为一个或多个第一曲折结构的部分,该第一曲折结构在其上包含贮藏器结构,并且贮藏器结构的相应锁定机构被锁定。 The expandable stent comprises a tubular structure, wherein the locking means is a respective one or more portions of the first meandering structure, the meandering structure comprises a first structure on which the receptacle and the receptacle structure corresponding locking mechanism is locking. 在一个实施方案中,可膨胀管状支架还包括一个或多个第二曲折结构,该第二曲折结构包括贮藏器结构以用于相应锁结构的锁合容纳;该可膨胀管状支架还可包括相应锁定机构,并且贮藏器结构的相应锁定机构被锁定。 In one embodiment, the expandable tubular stent further comprises one or more second meandering structure, the meandering structure comprises a second structure for storing a respective latch lock engagement receiving structure; the expandable tubular stent may further comprise a respective the locking mechanism, the locking mechanism and the corresponding receptacle structure is locked. 在一个实施方案中,可膨胀管状支架包括这样一种结构,其中第一曲折结构中的一个或多个包括贮藏器结构以用于相应锁结构的锁合容纳。 In one embodiment, the expandable stent comprises a tubular structure, wherein the first meander structure comprises one or more storage structures corresponding locking structure for locking engagement receiving.

[0054] 在另一个实施方案中,可膨胀管状支架包括这样一个结构,其中第二曲折结构中的一个或多个包括用于贮藏器结构的相应锁定机构,并且贮藏器结构的相应锁定机构被锁定;或者第二曲折结构中的一个或多个包括贮藏器结构以用于相应锁结构的锁合容纳。 [0054] In another embodiment, the expandable stent includes a tubular structure, wherein the second meander structure comprises one or more respective locking mechanism for the receptacle structure and the receptacle structure corresponding locking mechanism is lock; or the second meander structure comprises one or more storage structures corresponding locking structure for locking engagement receiving.

[0055] 在另一个实施方案中,可膨胀管状支架包括这样一个结构,其中第一曲折结构中的一个或多个包括相应锁结构,并且贮藏器结构的相应锁定机构被锁定。 [0055] In another embodiment, the expandable stent includes a tubular structure, wherein the first meander structure comprises the one or more respective lock structure, and a corresponding locking mechanism is locked storage structure. [0056] 在另一个实施方案中,可生物吸收的柔性支架以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可卷曲且可膨胀,而且具有以膨胀形式存在的式样形状,该支架包括:由管的近开口端螺旋状延伸到其远开口端的第一多部件支柱单元结构;由管的近开口端螺旋状延伸到其远开口端的第二多部件支柱单元结构;其中,当各部件由所述管的所述近开口端螺旋状延伸到其所述远开口端时,每个所述多部件支柱单元结构的部件相对于另一多部件支柱单元结构的另一部件成约120°至约180°。 [0056] In another embodiment, bioresorbable flexible stent circumferentially about the longitudinal axis is formed in the form of a tube, the tube having a proximal open end and the open distal end, and may be crimped and expanded to expand and having in the form of pattern shape, the stent comprising: a proximal open end of the helically extending tube member to a first multi-cell structure struts which open distal end; extending from the proximal open end to a second multi-tube helical member distal the open end thereof pillar cell structure; wherein when each of said pipe member by said helically extending into the proximal open end when said distal open end thereof, said strut member of each multi-cell structure of the multi-component relative to the other member strut unit another member of the structure to about 120 ° to about 180 °. 在一个实施方案中,支架包括这样一种结构,其中第一多部件支柱单元结构的各部件支柱单元结构的构型实质相同。 In one embodiment, the stent comprises a structure wherein the configuration of substantial parts of each pillar cell structure of the first multi-cell structure struts same member. 该支架还可包括这样一种结构,其中第二多部件支柱单元结构的各部件支柱单元结构的构型实质相同。 The stent may also comprise a structure wherein the configuration of substantial parts of each pillar cell structure of the second multi-cell structure struts same member. 或者,该支架可包括这样一种结构,其中第一和第二多部件支柱单元结构的各部件支柱单元结构构型实质相同。 Alternatively, the stent may comprise a structure in which each member of the first strut and the second cell structure pillar member multi-cell structure substantially the same configuration. 在该实施方案中,即其中位于第一多部件支柱单元结构和第二多部件支柱单元结构之间的该部件支柱单元结构的各对立部件构型实质相同;并且可形成固定的字母H构型、固定的X构型、固定的S构型、固定的8构型或固定的I构型。 In this embodiment, in which it is located a first plurality substantial same configuration opposite each strut member of the cell structure member between the structure and the second multi-column unit cell structural member strut member; and may form a fixed configuration of letter H , fixed X-configuration, S configuration is fixed, a fixed configuration or a fixed 8 I configuration.

[0057] 该支架可包括由管的近开口端螺旋状延伸到其远开口端的第三多部件支柱单元结构。 [0057] The bracket may include a proximal open end extending from the spiral tube to the third multi-cell structure which pillar member distal the open end. 该支架还可包括由管的近开口端螺旋状延伸到其远开口端的第四多部件支柱单元结构,以及由管的近开口端螺旋状延伸到其远开口端的第五多部件支柱单元结构。 The holder may further include a proximal open end extending from the spiral tube to the fourth plurality of unit structures which strut member open distal end and extending from the proximal open end of the spiral tube member to fifth multi-cell structure strut distal open end thereof. 一对多部件支柱单元结构的各螺旋可绕管沿左手螺旋方向绕转。 Pillar cell structure may be many members of each spiral around the tube along the revolving direction of the left-handed helix. 或者,该支架可包括这样一种结构,其中两个多部件支柱单元结构的各螺旋绕管沿右手螺旋方向绕转。 Alternatively, the stent may comprise a structure in which two multi-cell structure of the struts of each spiral around the tube member revolves in the right hand direction. 在另一个实施方案中,两个多部件支柱单元结构的至少一个螺旋绕管沿左手螺旋方向绕转,而另一个螺旋沿右手螺旋方向绕转。 In another embodiment, two multi-cell structure struts least one helical member revolves around the tube in the left-hand helix direction and the other in the right-handed helical swirling direction. 在又一个实施方案中,多部件支柱单元结构的所有螺旋绕管沿相同方向绕转。 In yet another embodiment, all of revolutions in the same direction around the tube spiral strut configuration of the multi-component unit.

[0058] 在另一个实施方案中,公开了这样一种可生物吸收的支撑管,其包括多个由管的近开口端螺旋状延伸到其远开口端的多部件支柱单元结构,其中当各部件由所述管的所述近开口端螺旋状延伸到其所述远开口端时,每个所述多部件支柱单元结构的部件相对于另一多部件支柱单元结构的另一部件成约120°至约180°。 [0058] In another embodiment, disclosed a bioabsorbable tube may be supported, comprising a plurality of helically extending from the proximal open end of the tube to the multi-cell structure strut member distal open end thereof, wherein when each member the tube extends from the proximal open end of the spiral to the distal open end thereof, said strut member of each multi-cell structure member relative to the other member of another multi-cell structure strut member at approximately 120 ° to about 180 °. 在该实施方案中,多部件支柱单元结构的各螺旋绕支撑管沿左手螺旋方向绕转;两个多部件支柱单元结构的各螺旋可绕支撑管沿右手螺旋方向绕转。 In this embodiment, each of the coil support tube around the helical direction along the left-hand column unit swirling multi-component structure; two multi-cell structure struts each helical member rotatable about the support tube along the revolving direction of the right-handed screw. 或者,该支架可包括多个螺旋,其中多部件支柱单元结构的至少一个螺旋绕支撑管沿左手螺旋方向绕转,而另一个螺旋绕支撑管沿右手螺旋方向绕转;或者其中多部件支柱单元结构的所有螺旋绕支撑管沿相同方向绕转。 Alternatively, the stent may comprise a plurality of spiral, wherein the plurality of struts cell structure at least one helical member revolves about the support tube in the direction of left-handed helix and the other right-handed spiral around the support tube in the helical direction about the rotor; or wherein a multi-part strut unit All orbiting spiral in the same direction about the support tube configuration.

[0059] 还提供了一种柔性支架,它以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可卷曲并可膨胀,而且在未膨胀的形式下具有式样形状,该支架包括:第一正弦曲线式支柱单元结构,其包括一系列由波峰部分和波谷部分确定的重复正弦曲线,所述重复正弦曲线由管的近开口端延伸到其远开口端;以及第二正弦曲线式支柱单元结构,其包括一系列由波峰部分和波谷部分确定的重复正弦曲线,第二正弦曲线式支柱单元结构的正弦曲线与第一正弦曲线式支柱单元结构的波峰和波谷的相差为约180° ;其中第二正弦曲线式支柱单元结构在至少两个点处与第一正弦曲线式支柱单元结构相连,并且其中各点处的连接由第一正弦曲线单元结构的正弦曲线的波峰到第二正弦曲线单元结构的正弦曲线的波峰。 [0059] further provided a flexible stent, which is formed circumferentially about a longitudinal axis form a tube, the tube having an open distal end and a proximal open end and a rollable and expandable, and has in the unexpanded form pattern shape, the stent comprising: a first sinusoidal strut unit structure, comprising a series of repeating sinusoids determined by the peak portions and trough portions, the sinusoid repeats extends from the proximal open end of the tube to the distal open end thereof; and a second sinusoidal strut unit structure, comprising a series of repeating sinusoids determined by the peak portions and trough portions, the second sinusoidal strut sinusoidal cell structure and cell strut first sinusoidal peak and trough structure the phase difference of about 180 °; wherein the second sinusoidal strut unit is connected to the structure at least at two points of the first strut sinusoidal cell structure, and is connected at various points by a sinusoidal wherein the first cell structure sinusoidal curve the peak-to-peak sinusoidal cell structures second sinusoidal curve.

[0060] 在一个实施方案中,该支架可包括这样一个结构,其中第一正弦曲线式支柱单元结构和第二正弦曲线式支柱单元结构重复多次、一个接一个以形成支架;或者其中第一正弦曲线式支柱单元结构和第二正弦曲线式支柱单元结构相同;或者其中第一正弦曲线式支柱单元结构和第二正弦曲线式支柱单元结构不同。 [0060] In one embodiment, the stent may include a configuration in which the first sinusoidal strut unit structure and the second sinusoidal strut unit structure is repeated a plurality of times, one after another to form the stent; or wherein the first sinusoidal strut same cell structure and the second structure sinusoidal strut unit; or wherein the first sinusoidal strut different cell structure and the second cell structure sinusoidal strut. 该支架可由可生物降解材料如聚-丙交酯制得。 The stent may be formed of a biodegradable material such as poly - lactide was prepared. 在该实施方案中,该支架包括这样一个结构,其中第二正弦曲线式支柱单元结构在至少三或四个点处与第一正弦曲线式支柱单元结构连接。 In this embodiment, the stent includes a structure in which the second sinusoidal strut unit structure is connected at at least three or four points of the first sinusoidal strut unit structure.

[0061] 在另一个实施方案中,可生物吸收的柔性支架以圆周形式绕纵轴形成这样一种管,该管具有近开口端以及远开口端,并且可卷曲和可膨胀,而具有非膨胀形式的式样形状,该支架包括:第一正弦曲线式支柱单元结构,其包括一系列由波峰部分和波谷部分确定的重复正弦曲线,所述重复正弦曲线由管的近开口端延伸到其远开口端;以及第二正弦曲线式支柱单元结构,其包括一系列由波峰部分和波谷部分确定的重复正弦曲线,第二正弦曲线式支柱单元结构的正弦曲线与第一正弦曲线式支柱单元结构的波峰和波谷同相;其中第二正弦曲线式支柱单元结构在至少两个点处与第一正弦曲线式支柱单元结构相连,并且其中各点处的连接由第一正弦曲线单元结构的正弦曲线的波峰到第二正弦曲线单元结构的正弦曲线的波峰。 [0061] In another embodiment, bioresorbable flexible stent circumferentially about the longitudinal axis is formed in the form of a tube, the tube having a proximal open end and a distal open end, and an expandable and rollable, and having a non-expanded in the form of pattern shape, the stent comprising: a first sinusoidal strut unit structure, comprising a series of repeating sinusoids determined by the peak portions and trough portions, the sinusoid repeats extends from the proximal open end of the tube to its distal opening end; and a second sinusoidal strut unit structure, comprising a series of repeating sinusoids determined by the peak portions and trough portions, the peak sinusoid second sinusoidal strut of the first cell structure sinusoidal strut cell structure and valleys in phase; wherein the second sinusoidal strut unit is connected to the structure at least at two points of the first strut sinusoidal cell structure, and is connected at each point where a peak of a sinusoidal configuration of a first cell to sinusoidal peak sinusoidal second sinusoidal cell structure.

[0062] 在该实施方案中,第一正弦曲线式支柱单元结构和第二正弦曲线式支柱单元结构重复很多次、一个接一个形成支架;第一正弦曲线式支柱单元结构和第二正弦曲线式支柱单元结构相同或不同。 [0062] In this embodiment, the first sinusoidal strut unit structure and the second sinusoidal strut unit structure is repeated many times, one after the stent is formed; a first sinusoidal strut unit structure and the second sinusoidal are identical or different structural units struts. 该支架可由可生物降解材料例如聚合物一如聚-丙交酯聚合物——制得;并且包括这样一种结构,其中第二正弦曲线式支柱单元结构在至少三或四个点处与第一正弦曲线式支柱单元结构连接。 The stent may be formed of a biodegradable material, for example, polymers as poly - lactide polymer - prepared; and comprises a structure in which at least the first three or four points of the second sinusoidal strut unit structure a sinusoidal strut connected cell structure.

[0063] 在一个其中管状结构为支撑管的实施方案中,该支撑管包括多个环绕管状结构直径的正弦曲线状的或曲折的支柱单元结构,其中各正弦曲线环状结构可在一点与相邻的正弦曲线环状结构连续。 [0063] In an embodiment wherein a support tube is a tubular structure, the support tube includes a plurality of sinusoidal diameter of the surrounding tubular structure or configuration meandering strut unit, wherein each cyclic structure may be sinusoidal phase and at a point o continuous sinusoidal cyclic structure. 相邻的正弦曲线/曲折单元结构可在至少一点连续。 Adjacent sinusoidal / unit meandering continuous structure at least one point. 在一个实施方案中,支撑管支架可由两种不同类型的曲折部件形成,所述第一曲折部件包括具有可延伸到支架整个圆周的波峰和波谷的Z字形单元结构/正弦曲线状结构,从而该曲折部件即使当支架结构处于完全膨胀的构型时可维持一个正弦曲线状即使当支架结构处于完全膨胀的构型。 In one embodiment, the support bracket may be formed meandering pipe member formed of two different types, the first member comprises a Z-shaped winding unit structure / sinusoidal structure may extend the entire circumference of the stent peaks and troughs, so that the even when the winding member is in a fully expanded stent structure configuration can be maintained even when a sinusoidal fully expanded configuration of the stent structure is. 第二类型的曲折部件也形成支撑管支架,并且可插入或位于相邻第一曲折部件之间,从而当该支架结构充分展开时,第二类型的曲折部件形成环状或箍结构,其可适应直至完全与使用支架的管状器官空间的直径相配合。 The second member is also formed zigzag type stent support tube, and may be inserted or positioned between the first member adjacent turns, so that when the support structure is fully deployed second meander type or cuff member to form a cyclic structure which may be until completely adapted to cooperate with the use of the stent diameter tubular organ space. 环状(还称为小圈)部件提供箍强度提高的管状支架并且可避免展开后的支架的瓦解。 Cyclic (also known as the small circle) members provides enhanced hoop strength to avoid collapse of the tubular stent and the stent may be expanded after. 更具体而言,该实施方案提供了处于膨胀状态的环或箍,其至少在管状器械的一端处于膨胀状态,用于在器官空间中保护或锚定支架位置。 More specifically, this embodiment provides a ring or cuff in an expanded state, an expanded state thereof in at least one end of the tubular instrument, or for protecting the organs in the anchor bracket position in space. 此外,另一个实施方案可提供至少一个被套入支架内的其它环或箍以避免支架由其植入位置脱位。 Further, another embodiment may provide at least one other ring or cuff quilt into the stent implantation site to prevent the stent from its dislocation. 该实施方案还可提供多个随机或以规律间隔式样沿支架的长度分布的小圈。 This embodiment may also provide a plurality of small random or at regular intervals along the support loop length distribution pattern. 在膨胀支架的情况下,小圈被设计为最大膨胀成环或箍形状,或者膨胀至一个程度以保持更具柔性、更小刚性结构特征的某些正弦曲线形状。 In the case of an expandable stent, it is designed as a small circle of maximum expansion hoop or ring-shaped, or expanded to a degree to keep the more flexible, less certain sinusoidal shape characteristics of the rigid structure. 在支架末端或沿支架轴的任何地方存在箍状第二曲折支柱,有助于避免支架通过紧紧推向器官空间、如心血管的壁而发生“移位”。 There is a second zigzag shaped stent strut end or cuff anywhere along the support shaft, the stent helps to avoid space by closely into organs, such as the occurrence of cardiovascular wall "displaced." 本发明的“移位”定义为植入物由器官空间中原位置逐渐脱位。 "Displacement" defined in the present invention is a dislocation of the implant gradually Central organ spatial position. 可通过搏动的器官壁以及体内流体流动所造成的该改变,可通过再结晶箍或环实体扭转,该实体横跨腔空间、紧压周围组织并且还具有足够的弹性和相容性以降低局部有害碰撞。 By changing the wall of the organ and the body fluid flow pulsation caused, by recrystallization cuff or ring twisting entity, the entity across the chamber space, and further pressed against the surrounding tissue and having sufficient elasticity to reduce localized compatibility harmful impact.

[0064] 各实施方案的器械可包括这样一种聚合物组合物,其设计成在非膨胀状态下具有柔性并具有与其膨胀成比例提高的刚性和强度。 Devices [0064] The various embodiments may include such a polymer composition, which is designed to have flexibility in the unexpanded state and having a rigid and expandable therewith to increase the proportion of intensity. 更具体而言,优选的实施方案被设计成使得来自于曲折度更小的第二曲折支柱部件的端环将伸展成箍构造,其中在该箍处支架聚合物获得抵抗用于器官移植空间中有利锚定的压力所必需的强度。 More specifically, a preferred embodiment is designed such that the second member from meandering strut tortuosity of smaller end extending into the cuff ring structure, wherein the polymer of the ferrule holder in place against the space for organ transplantation advantageously anchoring strength necessary pressure. 该支架强度差异的基础存在于聚合物组合物中,其表现出松散或卷曲构型的无定形母体,但当进行冷应变、膨胀或伸展时伴随着增强的结晶其引起了聚合物母体的重新排列,从而导致了成比例地提高了支架的机械强度。 The intensity difference of the stent base present in the polymer composition which exhibits a loose or curled configuration of the amorphous precursor, but cold strain, along with enhanced crystallization which causes the expansion or extension of the polymer matrix re arrangement, thus resulting in a proportional increase the mechanical strength of the stent.

[0065] 在一个实施方案中,该管状支架可包括一个或多个第二类型的曲折部件并可被置于具有交替式样的管状支架中的第一类型曲折部件之间,以根据所想要得到的管状支架的长度形成重复式样。 [0065] In one embodiment, the tubular stent may include one or more second meander type member and may be disposed between the tubular stent having an alternating pattern of a first type winding member, according to the desired the resulting length of the tubular stent formed of a repetitive pattern. 在另一个实施方案中,提供了这样一种支架构型,其包括连接于膨胀稳定的环形部件的曲折支柱部件以及有效地用于确保支架处于载体装置上卷曲位置的卡扣锁定工具。 In another embodiment, there is provided a stent configuration comprising an annular member attached to the expandable strut member meander stable and effective for ensuring the stent crimped in position snap locking means on the carrier means.

[0066] 在一个实施方案中,管状支架可以可卷曲且可膨胀的结构提供以用于与气囊血管成形术一起使用。 [0066] In one embodiment, the tubular stent may be crimped and expandable structure provides for the use with balloon angioplasty. 所述管状实施方案任选可包括一种保护机构,其可被置于管状结构/支架的各端或与其接近。 The tubular embodiment may optionally include one protection mechanism, which can be placed in the tubular structure / stent or close to each end. 在该实施方案中,保护机构可为不同的设计并且结构上成形以确保柔性塑料支架位于送递体系的载体部件上,并且其中该支架可在锁定位置上被卷曲以保持支架在血管植入物载体上固定。 In this embodiment, the protective means can be formed on different designs and structures to ensure the carrier member is located in the flexible plastic stent delivery system, and wherein the stent may be crimped in the locked position to hold the stent in the vascular implant carrier fixed. 该保护机构可包括例如机械锁定工具,如扣、钩、锁匙状结构、啮合结构和邻接结构等,其可彼此接合并确保支架以一种紧紧卷曲的构型位于载体上。 The protective means may comprise, for example, mechanical locking means, such as a buckle, a hook, key structure, and engagement structure adjacent structure, which can engage one another to ensure that the stent in a tightly curled configuration on a support. 保护机构可避免支架在展开过程中的移出或在植入载体上的转移。 Protection mechanism can be avoided during removal of the stent in the expanded or implanted in the transfer vector. 例如,锁定工具可结构上成形以例如以卡扣锁定工具的形式工作,并且可被置于支架的一端或与之接近,或者在其两端或与之接近。 For example, the locking means may be formed, for example, a snap locking structure in the form of the working tool, and may be placed at or near one end of the stent, or both ends thereof or close thereto. 该卡扣锁定工具可为指状延伸形式以滑过被置于管状构型的端部件中或与之接近的相邻相似弯曲的支架部件。 The snap locking means may be finger-like extensions in the form of slides are placed in a tubular configuration of the components at or near the end of the curved bracket adjacent similar member. 在支架在卷曲下来的转移位置可被锁定的一个实施方案中,该支架包括类似于楔形榫头型打孔结构的卡扣匙锁设计。 In one embodiment of the stent in the crimped down the transfer position may be locked, the key holder comprising a snap-lock design is similar to a dovetail-type perforated structure.

[0067] 在另一个实施方案中,该支架在卷曲下来的转移位置可被锁定,通过包括类似于球窝结合和槽样结合结构的卡扣匙锁设计的保护工具。 [0067] In another embodiment, the stent may be locked in the crimped down the transfer position, a snap-like protection means in conjunction with key lock structure similar design by including a ball and groove binding. 在另一个实施方案中,提供了这样一种卡扣匙锁构型,其中在曲折环结构上的一系列钩状支柱延伸物可与相邻对立排布的钩状支柱互锁。 In another embodiment, there is provided a snap lock key configuration, wherein a series of hook-shaped meander loop structure in the struts extending opposite the hook material may be adjacent struts interlock arrangement. 在其它实施方案中,锁定机构可包括摩擦力提高部件并且其它防滑性能可用于在卷曲支架中锁定。 In other embodiments, the locking mechanism may include a friction member and the other to improve the anti-slip properties may be used to lock the stent in the crimped. 因此,在本实施方案中,卷曲支架的机械联锁特征可通过纳入塑料组合物中的摩擦力特性而提高。 Accordingly, in the present embodiment, crimped stent mechanical interlock features may be improved by the inclusion of frictional characteristics of the plastic composition. 这些摩擦力提高特性可被加入到该组合物本身,或者结合到层形式或者隔离的或点刻的表面部件中。 These friction surface member may be added to improve the properties of the composition itself, or isolated form or incorporated into a layer of or in stippled. 合适的试剂包括离子型或非离子型物质。 Suitable agents include ionic or non-ionic substances. 非离子型相互作用或弱的吸引力在提高支架的摩擦力分向量中发挥着重要作用。 Non-ionic interactions or weak attraction plays an important role in improving friction points stent vector. 离子型添加剂优选以溶解形式浓缩于卷曲支架的锁定表面上以避免不想要的血浆蛋白质反应。 The ionic additive is preferably crimped stent concentrated dissolved form locking surface to prevent unwanted reactions of plasma proteins.

[0068] 在某些实施方案中,展开的支架的锁定工具可通过送递载体的膨胀装置而分开。 [0068] In certain embodiments, the locking means deployed stent expansion may be separated by means of delivery vectors. 根据其位置,支架的锁定特征可被选择来以不同速率从整个支架结构的彻底卷曲送递构型膨胀到具有足以植入血管壁上的内腔直径的过程中解锁。 According to its position, the locking characteristics of the stent can be selected to expand at different rates from the crimped delivery configuration complete the entire stent structure having a lumen diameter sufficient to process the vessel wall of the implant to unlock. 在一个实施方案中,该支架可被处理以由均一的圆柱形变化为更倾向圆锥形结构,从而可容易地安装、再定位和调整植入物。 In one embodiment, the stent may be treated to change by a cylindrical conical tends to a more uniform structure so as to be easily installed, adjusted and re-positioning of the implant. 例如,该支架植入物可为这样一种构型,其包括气囊型可逆胀大或膨胀工具,该工具将锁定的支架构型载至体内并通过以下方式将其置于目标区域:通过膨胀卷曲锁定的支架以打破锁定位置并通过伸展调整环成箍状形式并牢牢地接合内腔圆周。 For example, the stent graft may be a configuration which includes an airbag reversible swelling or expansion tool, the tool will be locked to the carrier of structure of the body and by way of placing the target area: by expanding crimped stent to break the locking position and the locking ring by stretching the band-like form and adjusted to firmly engage the circumference of the lumen. 气囊膨胀装置包括一种用于加热和/或冷却该器械的工具。 A heating apparatus comprising the airbag is inflated and / or cooling means for the instrument. [0069] 一种医疗器械实施方案,例如一种支撑管,可由一种包括这样一种聚合物的材料制得,该聚合物的降解部分在与身体组织和流体一例如血管壁一接触时表现“友好”。 [0069] The embodiment of a medical device, such as one supporting tube may be made of such a material comprising a polymer obtained, the polymer portion of the performance degradation when in contact with a body tissue such as a blood vessel wall and the fluid "friendly". 在一个具体实施方案中,该医疗器械包括一种具有足够慢的降解动力学以避免组织过载或炎性反应的聚合物,其中所述炎性反应可导致再狭窄,例如其提供临床上支撑强度的最少30天的保留。 In one particular embodiment, the medical device comprising a slow enough to avoid degradation kinetics having organized polymeric support or inflammatory reactions, wherein the inflammatory response may result in restenosis, such as its strength to provide support clinical of at least 30 days of reservation. 在一个实施方案中,该医疗器械可在植入后长达3-4个月仍保持在适当的位置,而无大量的生物吸收。 In one embodiment, the medical device can be held for up to 3-4 months is still in place after implantation, without a large number of bio-absorption.

[0070] 在一个实施方案中,该植入物可在植入后进行过渡改变,由植入时的固体柔性植入物变为植入后的“橡胶态”,表现出柔性、却有足够弹性和附着力从而可进行外科手术。 [0070] In one embodiment, the implant may be changed after implantation transition after the flexible implant from the solid implant upon implantation becomes "rubbery", exhibits a flexible, there is sufficient so as to be elastic and adhesion surgery.

[0071] 在一个实施方案中,选定用于制备器械的聚合物具有适于植入物在心血管脉冲收缩和舒张期间与血管壁进行无摩擦力接触的柔性和弹性。 [0071] In one embodiment, the polymer is selected having a suitable instrument for preparing implant cardiovascular pulse-free contraction and relaxation during frictional contact with the vessel wall in the flexible and elastic. 在一个实施方案中,该医疗器械包括一种可伸展的弹性支架,其具有足够的刚性强度以能经受住血管中波动的心血管压力。 In one embodiment, the medical device comprises an elastically stretchable stent having sufficient rigidity strength to withstand pressure in the cardiovascular vessel lived fluctuations. 例如,聚合物选择可根据基于以分子量降低表示的质量损失、机械性能的保持和组织反应的评估基准进行。 For example, the polymer can be selected according to the mass loss based on the evaluation to reduce the molecular weight indicated, maintaining the mechanical properties of the tissue response and the reference.

[0072] 在一个实施方案中,该植入物由这样一种可生物吸收的聚合物制造,其中该可生物吸收的聚合物的分子部分包括聚L-丙交酯或聚D-丙交酯作为基质聚合物,其中包括聚L (或D)-丙交酯-共-碳酸亚丙酯或者聚L (或D)-丙交酯-共-ε -己内酯的改性共聚物用于连接基质聚合物。 [0072] In one embodiment, the implant, wherein the portion of the polymer molecule which comprises a bioabsorbable poly-L- lactide polymer producing a bioabsorbable or a poly-D- lactide as the matrix polymer, which comprises poly L (or D) - lactide - co - propylene carbonate or poly L (or D) - lactide - co - [epsilon] - caprolactone modified copolymer used connecting the matrix polymer. 这些共聚物可以嵌段共聚物形式或“嵌段”无规共聚物形式合成,其中丙交酯链长足够长以发生结晶。 These copolymers may be block copolymers or in the form of "blocks" in the form of random copolymer synthesis, wherein the lactide chain length long enough to crystallize.

[0073] 在另一个实施方案中,该组合物包括这样一种基质共聚物,其中一个部分足够长并且无空间位阻以进行结晶,例如具有更小部分的L-丙交酯或D-丙交酯,如乙交酯或聚乙二醇(PEG)或单甲氧端基的PEG(PEG-MME)。 [0073] In another embodiment, the composition comprises a copolymer matrix, wherein a portion is sufficiently long and no steric hindrance for crystallization, for example, a D- or L- lactide prop-less portion lactides, such as glycolide or polyethylene glycol (PEG) or monomethoxy-terminated PEG (PEG-MME).

[0074] 在另一个实施方案中,该组合物除了基质共聚物之外还可含有改性聚合物或共聚物,它们也可具有提高的降解动力学,例如ε-己内酯共聚物部分,其中ε-己内酯保持无定形,从而使得所得的片段更易水解。 [0074] In another embodiment, the composition may contain in addition to the copolymer matrix modified polymer or copolymer, which may also have an increased degradation kinetics, e.g. ε- caprolactone copolymer fraction, wherein ε- caprolactone remains amorphous, such that the fragment was hydrolyzed more easily.

[0075] 在另一个实施方案中,该组合物可包括聚乙二醇(PEG)共聚物,例如PEG部分占约1%的AB双嵌段或ABA三嵌段。 [0075] In another embodiment, the composition may include polyethylene glycol (PEG) copolymers, for example, about 1% PEG moiety of the AB diblock, or ABA triblock. 在该实施方案中,丙交酯的机械性能(见Enderlie andBuchholz SFB May 2006)得以维持。 In this embodiment, the mechanical properties of the lactide ester (see Enderlie andBuchholz SFB May 2006) is maintained. 在该实施方案中,PEG或PEG-MME共聚物的引入也可用于促进药物附着到聚合物上,例如与药物释放(drug eluding)医疗器械一起使用。 In this embodiment, PEG or PEG-MME introduced into the copolymer may also be used to facilitate attachment of the drug to the polymer, for example, drug release (drug eluding) used with medical devices.

[0076] 在另一个实施方案中,该医疗器械包括一种含基质聚合物的聚合物支架,该基质聚合物包括高分子量共聚物(即2-3 IV共聚物)小于5%的低PEG含量的聚合物的组合,其能使得丙交酯嵌段结晶并将相当的强度赋予基质聚合物。 [0076] In another embodiment, the medical device comprising a polymer matrix containing polymer scaffolds, the polymer matrix comprises a high molecular weight copolymer (i.e., 2-3 IV copolymer) content of less than 5% low PEG polymer compositions, which enables the block-lactide crystals and the matrix polymer impart comparable strength.

[0077] 在一个实施方案中,该聚合物组合物使得聚合物重新排列并且使得产生结晶形态。 [0077] In one embodiment, the polymer composition so that the polymer and rearranged so that a crystalline form. 塑性变形将结晶性赋予聚合物分子。 The plastic deformation imparted crystalline polymer molecules. 结晶状态的聚合物比其无定形聚合物强度更大。 Polymer crystalline state is larger than the strength of an amorphous polymer. 在包括环状结构的支撑管实施方案中,环状结构或小圈可为这样一种材料状态,其比正弦曲线支撑管片段的固有强度更大,其可提高医疗器械的机械性能、提高加工条件并提供交联部分结晶——例如热交联——的可能。 In the embodiment comprises a support tube in the cyclic structure, the cyclic structure may be a small circle or a material state, which is larger than the inherent strength of the sinusoidal segment support tube, which may improve the mechanical properties of the medical device and improve processing conditions partially crystalline and provide crosslinking - e.g. thermally crosslinked - possible.

[0078] 本文所公开的其它实施方案包括缩短组合物中聚合物的降解时间,例如一种医疗器械包含一种具有提高的降解动力学的可生物吸收的聚合物。 [0078] Other embodiments disclosed herein include a reduction in the degradation time of the polymer composition, for example, a medical device comprising a polymer having improved degradation kinetics bioabsorbable. 在该实施方案中,原料可为较低分子量的组合物并且/或者可以使用更亲水或水解链易于分解的基质聚合物。 In this embodiment, the feedstock may be a lower molecular weight composition and / or may use a matrix polymer is more hydrophilic or readily hydrolyzable chain decomposition. [0079] 在另一种器械实施方案中,该医疗器械包括一个含标记分子的聚合共混物,所述标记分子例如一种不透射线物质、荧光物质或发光物质,其可用于医疗器械植入患者体内后对其进行检测或识别。 [0079] In another embodiment, the instrument, the medical device comprises a polymeric blend containing the labeled molecule, the label molecule such as one radiopaque substance, a fluorescent substance or a luminescent substance which can be used in medical devices implanted detecting or identifying them into the patient. 例如,可用作标记分子的化合物包括碘、磷、荧光基团等。 For example, a compound used as a marker molecule include iodine, phosphorus, fluorophores and the like. 医疗器械,例如使用荧光透视法、X射线、MR1、CT技术等的医疗器械,可用于检测不透射线物质。 Medical devices, for example, fluoroscopy, X-ray, MR1, CT technology, medical devices, may be used to detect a radiopaque material.

[0080] 在该实施方案和本发明的其它实施方案中,该医疗器械可包括用于局部施用的填充剂和一种或多种药物物质。 [0080] In this embodiment and other embodiments of the present invention, the medical device may include one or more fillers and topical administration of pharmaceutical substances. 该医疗器械可包括,例如一种生物制剂、药剂如一种包封药物(其可用于一如血管壁组织和内腔的一局部送递和治疗)。 The medical device may comprise, for example, a biological agents, encapsulating a pharmaceutical agent such as (a local delivery and treatment thereof may be used as vessel wall and lumen).

[0081] 在另一个实施方案中,提供了一种包含核心降解计划的支架结构,更具体地,该计划可同时缓慢释放用于治疗和预防组织炎症和血小板聚集的药物。 [0081] In another embodiment, there is provided a support structure comprising a degradable core program, and more specifically, the program can be simultaneously slowly release medicament for the treatment and prevention of platelet aggregation and tissue inflammation. 该聚合物组合物或共混物提供了原位均一降解,从而避免了聚合物的大块或颗粒释放。 The polymer composition or blend provides uniform degradation in situ, thereby avoiding the release of bulk or particulate polymer.

[0082] 在另一个实施方案中,该聚合物组合物用于制造植入患者体内的医疗器械。 [0082] In another embodiment, the polymer composition for the manufacture of medical devices implanted in the patient. 该医疗器械包括具有可生物降解、可生物吸收且无毒性能的支架,并且包括但不限于支撑管、支撑管移植物、血管合成移植物、导管、血管分流器、瓣膜等。 The medical device comprising a biodegradable, bioresorbable and non-toxic properties of the stent, and including but not limited to support tube, the support tube graft, a synthetic vascular grafts, catheters, vascular shunts, valves and the like. 生物相容的且可生物吸收的支架可特别用于治疗冠状动脉。 Biocompatible and bioabsorbable stent may be particularly useful in the treatment of coronary artery. 例如,支架结构可由一种含一种基质聚合物材料、至少一种局部递送的药物和至少一种附着或包埋识别标记物的组合物制造或挤出。 For example, the support structure may be a substrate containing polymeric material, at least one topical drug delivery and at least one identification marker attached to or embedded in the extruded composition or manufacture.

[0083] 在另一个实施方案中,公开了一种治疗血管疾病的方法,该方法包括:向患血管疾病的人施用一种这样的医疗支架或器械,其包括一种由生物相容性可生物吸收的聚合物制备的结构。 [0083] In another embodiment, there is disclosed a method of treating a vascular disease, the method comprising: administering one such stent or medical device to a person suffering from vascular disease, which may include one of a biocompatible structure made of a bioabsorbable polymer.

附图说明 BRIEF DESCRIPTION

[0084] 与本文一起提供的图描绘了如示例性实例所述的实施方案,不认为这些实例以任何方式限制本发明。 [0084] FIG herein provided with such exemplary embodiment depicts an exemplary embodiment of the examples, that these examples do not limit the invention in any way.

[0085] 图1为一张计算机模拟图,其图示了一个可生物吸收的医疗器械的实施方案的局部视图,图示了支架支柱片段、嵌套的箍结构、端环、锁定机构和相互连接的“H”部位。 [0085] Figure 1 is a computer simulation diagram which illustrates a partial view of an embodiment of a bioabsorbable medical device, illustrating a fragment of the stent struts, hoops nested structure, the end rings, and each locking mechanism "H" connection site.

[0086] 图2为针对一种实施方案的计算机生成图,该实施方案包含一种处于稍有膨胀的构型状态下的可生物吸收支撑管设计,示出了嵌套的箍或环结构、端环、曲折支柱单元结构和锁定机构。 [0086] FIG. 2 is a view of one embodiment directed to a computer program to generate, in this embodiment comprising one biologically in a state slightly expanded configuration absorber support tube design is shown nested hoop or ring structure, end rings, meandering struts cell structure and a locking mechanism.

[0087]图3A描绘了一种计算机模拟图,其图示了一种过早膨胀的可生物吸收支撑管支架,该图示出了交替的环或箍结构以及一种曲折支柱部件单元结构和锁定机构。 [0087] FIG 3A depicts a computer simulation diagram which illustrates a premature expansion bioabsorbable stent support tube, which illustrates an alternate ring or ferrule member and one cell structure and the meandering strut The locking mechanism. 图3B为与图3A相同的支撑管支架,其示出了处于不同应力状态下的环片段。 3B is a view similar to the support tube holder 3A, which shows a ring segment in different stress state.

[0088] 图4A为一张示出了一种可生物吸收的支撑管支架单元结构的一个实施方案的平面图,其描绘了具有重复的S形支柱单元结构特征的可生物吸收支架的平面图,其中S形可用所示的其它设计方案代替。 [0088] FIG. 4A is a plan view illustrating an embodiment of a cell structure of the support tube A bioabsorbable stent, a plan view depicting an S-shaped strut having a repeating structural feature bioabsorbable scaffold unit, wherein further embodiments can be replaced with an S-shaped as shown. 图4A还示出了嵌套的箍/环结构。 Figure 4A also shows the nested hoop / ring structure. 图4B为平面构型的另一实施方案,其示例出了嵌套的环部件,其中该支撑管支柱结构可用8处所涵盖的设计方案代替。 4B is a planar configuration of another embodiment, an example of a nested loop member, wherein the support tube strut structure may be covered by the design spaces 8 in place. 图4C为本发明一个实施方案的平面图,其中该结构单元形成螺旋状结构。 FIG 4C a plan view of the embodiment of the present embodiment of the invention, wherein the structural unit forms a helical structure. 图4D示出了具有如所制造的形式所示的箍或环结构部件和支架部件的部分支撑管结构。 FIG 4D shows a partial structure having a support tube or ferrule member and the bracket member ring structure as illustrated in the form of fabricated. 图4E示出了处于部分膨胀构型的图4D的支撑管结构。 4E shows a support tube structure in a partially expanded configuration of FIG. 4D. 图4F示出了处于膨胀构型的图4D的支撑管结构。 FIG 4F illustrates a support tube structure is in the expanded configuration of FIG. 4D.

[0089]图5描绘了可生物吸收支撑管实施方案的斜视图,其表现出正弦曲线式样的曲折支柱片段。 [0089] FIG. 5 depicts a perspective view of a support bioabsorbable tube according to the embodiment, which exhibits a sinusoidal meandering strut pattern segment.

[0090] 图6A描绘了一种支撑管实施方案中的膨胀箍或环以及曲折或正弦曲线(6B)式的可生物吸收支柱部件的局部俯视图。 [0090] Figure 6A depicts an embodiment of the support tube or hoop expansion ring, and meandering or sinusoidal partial top plan view of a post member (6B) of formula bioabsorbable. 图6C示出了可生物吸收支撑管的箍或环部件,其示出了径向/横向载荷如何分布在整个环结构上。 6C shows a bioabsorbable support tube cuff or ring member, which shows a radial / lateral load how distributed throughout the ring structure.

[0091] 图7A-7C示出了可生物吸收医疗器械的实施方案中的聚合物纤维排列以及该排列在受到应力时如何进行塑性变形。 [0091] Figures 7A-7C illustrate an embodiment of a bioabsorbable medical device in the polymeric fibers are arranged and how the arrangement plastically deform when subjected to stress. 图7A示出了用于制备该器械的聚合物组合物的无定形状态。 7A shows a state of an amorphous polymer composition used in the instrument's. 图7B示出了部分膨胀构型中的聚合物纤维排列,图7C示出了一种实施方案的可生物吸收支撑管膨胀时纤维的晶体状态的实施方案。 7B shows a portion of the polymer fibers are arranged in the expanded configuration, Figure 7C shows an embodiment of a support embodiment bioabsorbable crystalline fiber state the tube expands.

[0092] 图8A示出了可生物吸收支撑管支架实施方案的平面图,该实施方案的支撑管支架包括结构曲折的支柱部件、嵌套的箍/环部件并在支撑管的开口处具有端环。 [0092] FIG. 8A shows a plan view of a bioabsorbable stent embodiment of the support tube, the support tube stent embodiment includes a configuration meandering strut member, nested hoop / ring member and having an end ring at the opening of the support tube . 图8B为图8A的支撑管支架部分的平面图,其示出了形成支撑管支架的结构曲折的支柱部件、嵌套的箍/环部件以及连接结构。 8B is a plan view of the support bracket portion of the tube of FIG. 8A, which shows the meandering strut members form a support structure of the stent, nested hoop / ring member and a connection structure. 支撑管支架以制造时的状态示出,并且还示出了多种构型的嵌套的环结构,以及结构曲折的部件与箍部件之间的以固定的字母H形状的连接。 Bracket support tube in a state shown during production, and also shows the shape of the letter H at a fixed connection between the various configurations of the nested loop structure, and the meandering of the clamping member and the structural member. 图SC示出了膨胀构型的图8B片段。 FIG SC expanded configuration is shown in FIG. 8B fragment. 图8D、8E和8F为可生物吸收支撑管支架壁的平面图,其示出了连接部件的其他设计实施方案,它们可在曲折支柱部件之间替换。 FIG. 8D, 8E and 8F is a plan view of a bioabsorbable tube wall of the stent support, which illustrate other embodiments of connector member design, they may alternatively between meandering strut member. 图8G为可生物吸收支撑管支架壁的平面图,其示出了支架和箍/环单元结构的另一设计实施方案以及该设计方案如何通过可替换连接部件的变更以改变该支撑管支架的柔性。 FIG. 8G is a plan view of the support tube wall of the stent may be bio-absorption, which shows another embodiment of a stent design and hoop / ring unit structure and design by alternatively changing how the connection member to change the flexibility of the stent support tube . 图8H示出了所制造的支撑管支架,其示出了插入曲折支柱部件之间的嵌套的箍/环结构。 FIG. 8H shows the support stent manufactured, which is shown inserted between the nested meandering strut member hoop / ring structure. 图81为部分膨胀构型状态下的图8H,图8J与处于膨胀构型的8H相同,图8K处于充分膨胀的构型。 FIG 81 is a view of a lower portion of the expanded configuration state 8H, 8H-8J in the expanded configuration with the same, FIG. 8K is fully expanded configuration.

[0093]图9A描绘了可生物吸收支撑管支架的平面图,其示出了多种部件、嵌套的箍/环结构部件、曲折/正弦曲线状的支柱部件、端环部件和经变更后的其中各部件相接为O-环状的连接结构。 [0093] Figure 9A depicts a plan view of a bioabsorbable stent support tube, which shows various components, the nested hoop / member ring structure, meandering / sinusoidal strut members, the end ring member and the altered wherein each contact member is connected to an annular structure O-. 图9B示出了膨胀构型的图9A所示支撑管结构支架的斜视图。 9B shows a perspective view of the support structure of the stent tube expanded configuration shown in FIG 9A.

[0094] 图1OA示出了如图9A中所绘的`可生物吸收支架的连接部件,其示出了所制造的连接状态;图1OB和IOC处于部分膨胀状态并且图1OD处于充分膨胀状态。 [0094] FIG 1OA illustrates a connection member can be `bioabsorbable stent depicted in FIG. 9A, which shows a connection state produced; and FIG 1OB IOC in a partially expanded state and FIG. 1OD in a fully expanded state.

[0095] 图1lA描绘了非膨胀的另一可生物吸收支撑管支架设计的平面图,其示出了支柱部件之间连接的另一单元结构并包括端环结构。 [0095] FIG. 1lA depicts a plan view of another unexpanded tube support bioabsorbable stent design, which shows another structure of the connection between the cell and the strut member includes an end ring structures. 图1lB为膨胀构型的图11A。 FIG 1lB is expanded configuration of FIG. 11A. 图1lC示例出了处于膨胀构型下的安置于气囊式导管上的图1lA中所示的可生物吸收的支撑管结构。 FIG 1lC example a tube support structure is disposed in the expanded configuration shown in FIG. 1lA the balloon catheter is bioabsorbable.

[0096] 图12A描绘了可生物吸收支撑管支架结构的另一实施方案的平面图,其示出了处于膨胀构型下的支柱部件和箍/环部件的另一设计方案。 [0096] FIG 12A depicts a plan view of another embodiment of bioabsorbable support structure of the embodiment of the tube support, showing a strut member and ferrule / further embodiment of the ring member is in the expanded configuration. 图12B为处于膨胀状态的安置于气囊式导管上的图12A的可生物吸收支撑管结构。 12B is disposed in an expanded state in FIG. 12A the balloon catheter bioabsorbable tube support structure.

[0097] 图13A示出了这样一种可生物吸收支撑管支架实施方案,其包括置于端环处和支柱片段支架之间的连接部件上的不透射线标记结构。 [0097] FIG. 13A shows a bioabsorbable stent support tube embodiment comprising a radiopaque marker disposed on the connection structure between the end ring member and the segment support struts. 图13B示出了这样一种实施方案,其中不透射线材料以斜列式样安置,用于在该器械植入后对其进行放射照相术而识别。 13B shows such an embodiment, wherein the radiopaque material disposed in echelon pattern, for identifying them radiography after implantation of the device.

[0098] 图14A-14D示出了可生物吸收支撑管支架的分离出的标记指示结构的另一实施方案的截面图。 [0098] FIGS. 14A-14D shows a sectional view of another embodiment of a bioabsorbable stent support isolated structure indicated by the marker scheme.

[0099] 图15A和15B还示出了指示不透射线标记物被置于可生物吸收的支撑管支架实施方案的位置,并且图15C为对可生物吸收支撑管支柱实施方案中的不透射线标记指示物进行的放射照相图。 [0099] Figures 15A and 15B illustrate further indicate radiopaque markers are placed embodiment stent support tube bioabsorbable position, and FIG. 15C is a pair of pillar support tube embodiment bioabsorbable radiopaque scheme FIG radiographic markers was indicated.

[0100] 图16A示出了处于膨胀构型的支撑管实施方案的一端的平面图,所述支撑管实施方案包括端环部件、锁定机构和支撑管支柱曲折部件。 [0100] FIG. 16A shows a plan view at one end of the expanded configuration of an embodiment of the support tube, the support tube embodiment includes an end ring member, the locking mechanism and the support tube meandering strut member. 图16B为图16A所示支撑管支架卷曲构型。 FIG. 16B support stent is crimped configuration in FIG. 16A. 图16C示出了膨胀支撑管支架,其中示出了应力分布。 FIG 16C shows expandable stent support tube, showing a stress distribution. 图16D示出了可生物吸收支撑管支架实施方案的片段,其示出了嵌套的箍/环结构、支撑管曲折片段和锁定机构或固定部件(retention feature),其可针对接合进行设计方面的改变。 16D shows a fragment bioabsorbable stent embodiment of the support tube, which shows nested hoop / ring structure, meandering segment and the support tube fixing member or a locking mechanism (retention feature), which can be engaged for the design of It changes.

[0101] 图17A和17B描绘了支撑管支架的其他实施方案在膨胀状态下的平面图,并示出了其端部的脱开的锁定机构和端环结构。 [0101] Figures 17A and 17B depict a plan view showing another embodiment of a support stent in the expanded state, and shows a releasable locking mechanism in its end and the end ring structures.

[0102] 图18A-18F示出了可生物吸收的支撑管支架的另一实施方案,其以平面图和斜视图示出了在该器械的端环处的以及处于脱离和接合位置的锁定机构。 [0102] FIGS. 18A-18F illustrate another embodiment of the support tube bioabsorbable stent, which is a plan view and a perspective view showing the end ring at the instrument and a locking mechanism is in the engaged and disengaged positions. 图18G示出了这样一种实施方案,其中支撑管支架被安置于气囊式导管上并且锁定机构接合以使支撑管以均一构型处于支撑管主体平面内而维持在导管上。 FIG 18G shows such an embodiment in which the support stent is disposed on a balloon catheter and the locking mechanism engages the support tube to a uniform configuration is in the plane of the support tube body is maintained on the catheter. 图18H为图18G的支撑管支架的前视图,其示出了圆形的导管、端环和气囊。 FIG 18H is a front view of the support tube bracket of FIG. 18G, which shows a circular conduit, the end rings and bladder.

[0103] 图19A描绘了支撑管支架实施方案的平面图,其示出了所制造的支撑管端部的锁定机构的备选实施方案。 [0103] FIG 19A depicts a plan view of the embodiment of the stent support tube, which illustrates an alternative embodiment of the locking mechanism of the support tube end portion being fabricated. 图19B描绘了处于卷曲位置的图19A,其示出了接合的锁定机构。 FIG. 19B depicts a crimped position in FIG. 19A, which shows the locking mechanism engages. 图19C示出了处于卷曲位置的锁定机构的放大平面图,图19D示出了其部分膨胀构型,图19E示出了锁定机构部分接合的端环的斜视图;图19F示出了卷曲状态,图19G示出了安置于气囊式导管上的状态。 FIG 19C illustrates an enlarged plan view of the locking mechanism is in its crimped position, FIG 19D shows a partially expanded configuration, FIG. 19E shows a perspective view of the locking portion of the engagement mechanism of the end ring; FIG. 19F shows a crimped state, FIG 19G shows a balloon catheter disposed on state.

[0104] 图20A描绘了处于膨胀构型的可生物吸收支撑管的实施方案中锁定机构的另一设计方案的平面图;图2(«描绘了其卷曲构型。图20C为端片段的平面图,其示出了处于卷曲构型时卡扣锁定端,图20D示出了其膨胀构型时卡扣锁定端。图20E和20F表示分别处于膨胀构型和卷曲构型的图20A-20F的支撑管支架的斜视图。图20G示出了被安置于气囊式导管上的支撑管支架。 [0104] FIG 20A depicts a plan view of another embodiment of the design in the expanded configuration bioabsorbable support tube locking mechanism; FIG. 2 ( «crimped configuration depicted in FIG. 20C is a plan view of the end of the fragment. which is shown in a curled configuration when the snap locking end, FIG. 20D showing its expanded configuration when the snap locking end. FIG. 20E and 20F are respectively represented in the expanded configuration the support and crimp configurations of FIGS. 20A-20F perspective view of the tube holder. FIG. 20G shows is disposed on a balloon catheter stent support tube.

[0105] 图21描绘了置于人拇指与食指之间的所制造的可生物吸收支撑管支架的照片,其表现出该器械的柔性。 [0105] FIG. 21 depicts photographs biologically produced between thumb and index finger is placed human absorption bracket support tube which exhibits flexibility of the instrument.

具体实施方式 Detailed ways

[0106] 本文公开了新的结构部件,以及可用于制备所述新结构部件的新组合物。 [0106] Disclosed herein are new structural components, as well as new compositions can be used in preparing the new structural member. 本发明实施方案可用于治疗多种疾病和生理失调。 Embodiments of the invention are useful for treating a variety of diseases and physiological disorders.

[0107] 近年来,已开始使用金属支撑管以帮助清除血管体系的堵塞的内腔。 [0107] In recent years, the use of a metal support tube started to help clear the blockage of the lumen of the blood vessel system. 然而,植入血管动脉的金属支撑管植入物的效能已由于某些不利的结果而降低。 However, the effectiveness of the metal support tube implant implanted arteries have some adverse consequences reduced. 例如,因为所述支撑管已表现出刺激伤口处瘢痕组织或再狭窄形成的倾向,其中所述伤口是在血管区域展开中所造成。 For example, since the support tube has been shown to stimulate scar tissue tends to wound formation or restenosis, wherein the wound is caused in a blood vessel in the expanded area. 该效应在使用小直径管的治疗中变得更加不利。 This effect becomes even more disadvantageous treatment using a small diameter tube. 此外,重要的是在支撑管插入期间要避免动脉壁损伤。 In addition, it is important to support the tube during insertion to avoid damage to the arterial wall. 这些因素(尽管在第一种情况中稍难控制)的目标在于试图降低在血管内腔中引起过多的凝块和瘢痕形成的机械原因。 These factors (although a little difficult to control in the first case) is aimed at trying to reduce the mechanical causes of excessive clot and scar formation in the blood vessel lumen.

[0108] 支撑管结构通常包括大量曲折单元结构。 [0108] tube support structure typically include a large meander cell structure. “曲折”的含义为沿非严格直线的路线移动。 "Twists and turns" in the strict meaning of the non-linear movement along the route. 由于需要具有非膨胀形式以便于将支撑管容易地插入其生物环境(例如但不限于脉管系统),构成支撑管的曲折单元结构通常实际上为正弦曲线,也就是说具有重复的波峰和波谷的排列。 Since the need to have a non-expanded form so as to be easily inserted into the support tube biological environment (e.g., but not limited to, the vasculature), constituting the support tube meander units actually generally sinusoidal configuration, i.e. having repeating peaks and valleys arrangement. 通常所述正弦曲线结构被标准化从而使得各波峰或波谷距中线的所测距离一般相同。 The structure is generally sinusoidal so that each of the normalized peak or trough distance measured from the center line of the same general. “非正弦曲线”的含义为这样一种式样,其不具有重复的波峰和波谷的序列并且不具有一系列距中线的所测距离大体相同的上升部分也不具有一系列距中线的所测距离大体相同的下降部分。 The meaning of "non-sinusoidal" is a pattern which does not have sequence repeats of peaks and troughs and having no series midline rising portion is not substantially the same distance measured from the midline with a series of distance measurements the decline in much the same section. 支撑管的特征可为具有以下三种不同的构型:非膨胀状态(制备得)、卷曲状态(与非膨胀状态相比的压缩状态)和膨胀状态(体内植入物展开时)。 Wherein the support tube can have three different configurations: (in vivo implant deployment) non-expanded state (Preparation too), the curl state (a compressed state as compared to non-expanded state) and the expanded state.

[0109] 本发明所公开的构型不限于通过任何特定材料制造,但在某些实施方案中所述构型由柔性、弹性的可生物吸收的塑性支架构造。 [0109] The present invention is not limited to the configurations disclosed by any particular manufacturing material, but in some embodiments the plastic stent configuration bioabsorbable configured from a flexible, resilient. 本发明所公开的实施方案示例出了由可生物吸收聚合物和聚合物组合物制造的多种形状、式样和特征的可生物吸收的且可膨胀支架。 The disclosed embodiments of the present invention illustrating example various shapes, styles and characteristics of the polymer and polymer compositions produced bioabsorbable and bioabsorbable expandable stents. 一个有利的实施方案中的支架平衡了弹性、刚性和柔性的性能,同时比现有技术中的聚合物医疗器械更具生物相容性、更不容易形成血栓和免疫原性。 One advantageous embodiment of the stent balanced elasticity, rigidity and flexibility properties, while more biocompatible than the prior art polymer medical device, and is less immunogenic clots. 所述实施方案可提供用于当卷曲置于载体上以及当膨胀置于活的器官空间中时避免器械移位或改变位置的工具。 The embodiment can provide a support for the instrument and to avoid shifting or changing position in space of a living organ when the expansion tool is placed when the curl is placed. 支撑管植入物可使用气囊式可膨胀医疗器械,其包括热气囊或非热气囊。 Implant may be used to support a balloon expandable medical device, which comprises a thermal or nonthermal airbag airbag.

[0110] 现参照附图,图1为一张计算机模拟图,其图示了一个处于非膨胀形式的可生物吸收的医疗器械的实施方案的局部视图,图示了支架支柱片段17、嵌套的箍结构14和端环16,两者均包括不在同一平面内的结构,锁定机构18连接到另一个锁定机构(未示出)上,以及相互连接“H”部位15在嵌套的箍结构14处具有环膨胀通孔11。 [0110] Referring now to the drawings, Figure 1 is a computer simulation diagram which illustrates a partial view of the embodiment in a non-expanded form a bioabsorbable medical device, illustrating a stent strut fragments 17 nested the ferrule 14 and the end ring 16, including both the structure are not in the same plane, the locking mechanism 18 is connected to the other locking mechanism (not shown), and connected to each other "H" nested portion 15 of ferrule the expansion ring 14 has a through hole 11.

[0111] 图2为针对一种实施方案的计算机生成图,该实施方案包含一种处于稍有膨胀的构型状态下的可生物吸收支撑管设计,示出了目前现在大致体上位于同一平面内的嵌套的箍结构14(或环结构)和端环16,曲折支柱单元结构17,以及和与另一锁定机构分离的另一个锁定机构18。 [0111] FIG. 2 is a computer-generated diagram for one embodiment, which includes one embodiment in the configuration biologically slightly expanded state absorber support tube design, the current shown are in substantially the same plane thereof 16, meandering struts cell structure 17, and be separated from another and the locking mechanism further nested within the ferrule 14 (or cyclic structure) and the end ring 18 locking mechanism. 所示膨胀通孔11在这种膨胀构型中已被拉伸成一个长椭圆形的孔。 FIG expansion through hole 11 in this expanded configuration and is stretched to have an oblong hole.

[0112]图3A描绘了一种计算机模拟图,图示了一种过早膨胀的可生物吸收支撑管支架,该图示出了交替的环或箍结构以及一种曲折支柱部件单元结构17和锁定机构18。 [0112] FIG 3A depicts a computer simulation diagram illustrating a premature expansion bioabsorbable stent support tube, which illustrates an alternate ring or ferrule and one meandering strut member 17 and the cell structure The locking mechanism 18. 图3B为与图3A中相同的支撑管支架,其示出了处于不同应力状态下的环片段。 3A and FIG. 3B is the same stent support tube, which is shown in a ring segment in different stress states. 在两者的任一情况下,包括各环或箍的结构大致位于同一平面内。 In either case both, comprising each ring or hoop configuration substantially in the same plane.

[0113] 图4A为一张示出了一种可生物吸收的S形支撑管支架单元结构15的一个实施方案的平面图,其中S形可用所示的其它设计方案代替。 [0113] FIG. 4A is a plan view illustrating a bioabsorbable an S-shaped tube support supports one embodiment of the cell structure 15, wherein the other of S-shaped design shown can be replaced. 图4A还示出了嵌套的箍/环结构 Figure 4A also shows the nested hoop / ring structure

14。 14. 图4B为平面构型的另一实施方案,其示例出了嵌套的环部件14,其中该支撑管支柱结构可用8处所包括的任何设计方案取代。 4B is a planar configuration of another embodiment, an example of a nested loop member 14, wherein the support tube strut structure may be substituted with any design included at 8. 图4C为一张本发明的非膨胀支架实施方案的平面图,其中结构正弦曲线单元结构17在整个结构中形成螺旋状式样结构9(如平面图中斜列式样所示)。 FIG 4C is a plan view of an embodiment of the present unexpanded stent embodiment of the invention, wherein the structural unit structures sinusoidal helical pattern structure 917 is formed (as shown in echelon pattern in plan view) in the overall structure. 图4D示出了图4C支架形成的具有以所制造形式的箍或环结构部件14和支架部件的部分非膨胀支撑管结构16。 4D shows a portion having a non-expandable support structure 14 and the tubular member of the stent hoop or ring structure member 16 fabricated in the form of the bracket of FIG. 4C is formed. 图4E示出了处于部分膨胀构型的图4D的支撑管结构。 4E shows a support tube structure in a partially expanded configuration of FIG. 4D. 图4E示出了处于膨胀构型的具有大体位于同一平面内的的延伸环的图4D的支撑管结构。 FIG. 4E shows the support having a generally tubular structure extending ring located within the same plane in FIG. 4D in the expanded configuration.

[0114] 图5描绘了未膨胀可生物吸收的支撑管实施方案的斜视图,其表现出正弦曲线式样的曲折支柱片段22和端环23。 [0114] FIG. 5 depicts a perspective view of the unexpanded embodiment of the support tube may be bio-absorbable, which exhibits a sinusoidal pattern meandering strut segments 22 and the end ring 23.

[0115] 图6A描绘了支撑管实施方案的膨胀箍或环的局部俯视图,而图6B示出了非膨胀时的所述箍或环,在图中示出了由曲折的正弦曲线(6B)状的可生物吸收支柱部件构成的支撑管实施方案。 [0115] Figure 6A depicts a partial top view of inflated cuff or ring support tube embodiment, and FIG. 6B shows the band or ring when unexpanded, in the figure is shown by the zigzag sinusoidal (6B) shaped bioabsorbable support tube embodiment strut member thereof. 图6C示出了可生物吸收支撑管的箍或环部件,其示出了径向/横向载荷如何分布在整个环结构上。 6C shows a bioabsorbable support tube cuff or ring member, which shows a radial / lateral load how distributed throughout the ring structure. 如所示出的,这种结构提供了更好的力分布,从而使所述支撑管在其它方式可能造成该支撑管变形的作用力下处于开放状态。 As shown, this arrangement provides a better force distribution, so that the support tube may otherwise result in an open state under the biasing force of the support tube deformation.

[0116] 图7A-7C示出了可生物吸收医疗器械的实施方案中的聚合物纤维排列以及该排列在受到应力时如何进行塑性变形。 [0116] Figures 7A-7C illustrate an embodiment of a bioabsorbable medical device in the polymeric fibers are arranged and how the arrangement plastically deform when subjected to stress. 图7A示出了用于制备该器械的聚合物组合物的无定形状态。 7A shows a state of an amorphous polymer composition used in the instrument's. 图7B示出了部分膨胀构型中的聚合物纤维排列,图7C示出了一个实施方案的可生物吸收支撑管在膨胀时纤维的晶体状态,该实施方案的支撑管由外消旋或立体复合物聚合组合物组成。 7B shows a portion of the polymer fibers are arranged in the expanded configuration, Figure 7C shows a tube embodiment of a crystalline state bioabsorbable support fibers when inflated, the support tube of the embodiment of a racemic or stereoisomer composite polymeric composition components.

[0117] 图8A示出了未膨胀的可生物吸收支撑管支架实施方案的平面图,该实施方案包括结构曲折的支柱部件17、嵌套的箍/环部件14,并在支撑管的开口处具有端环16。 [0117] FIG. 8A shows a plan view of the unexpanded stent support tube bioabsorbable embodiment, this embodiment includes a strut member 17, convoluted, nested hoop / ring member 14, and having at the opening of the support tube end ring 16. 图SB为图8A的支撑管支架的一部分的平面图,其示出了形成支撑管支架的结构曲折的支柱部件17、嵌套的箍/环部件28、30以及连接结构。 FIG. SB is a plan view of a portion of the stent support tube of FIG. 8A, which shows the meandering strut members form a support structure of the stent 17, 28, 30 and a connection structure nested hoop / ring member. 支撑管支架以制造的状态示出,并且还示出了多种构型的嵌套的环结构28、30。 Support stent manufactured in a state shown, and further illustrates the various configurations of the nested loop structure 28, 30. 就结构曲折部件与箍部件之间的连接而言,可见固定的字母H形状。 For connection to meander between the structural member and the clamping member, seen stationary letter H shape. 图SC示出了膨胀构型的图SB片段。 FIG SC expanded configuration is shown in FIG. SB fragment. 图8D、8E和8F为可生物吸收支撑管支架壁的平面图,其示出了曲折支柱部件17与环结构15 (嵌套的)和16 (末端环结构)之间连接点的其他设计方案17。 Other designs of connection points between the FIG. 8D, 8E and 8F plan view of the absorbent support tube wall of the stent is biodegradable, which shows the meandering strut member 17 and the ring structure 15 (nested) and 16 (end of the ring structure) 17 . 图8G为可生物吸收支撑管支架壁的平面图,其示出了支柱和箍/环单元结构的另一设计实施方案以及该设计如何能够通过其他连接部件的变更进而改变该支撑管支架的柔性。 FIG. 8G is a plan view of a support stent wall is bioabsorbable, which shows a further embodiment of the cuff and strut / ring unit structure and how the design can be changed and thus the flexibility of the stent support tube by changing the other connection member. 图8H示出了所制造的支撑管支架,其示出了插入曲折支柱部件之间的嵌套的箍/环结构。 FIG. 8H shows the support stent manufactured, which is shown inserted between the nested meandering strut member hoop / ring structure. 图81为处于部分膨胀构型的图8H,图8J与处于膨胀构型的8H相同,并且图8K处于充分膨胀的构型。 FIG 81 8H, 8H-8J and in the expanded configuration is the same as in a partially expanded configuration, and FIG. 8K in a fully expanded configuration.

[0118]图9A描绘了可生物吸收支撑管支架的平面图,其示出了多种部件、嵌套的箍/环结构部件28、曲折/正弦曲线状的支柱部件38、端环部件16和经变更后的在各部件相接处为ο-环状的连接结构6。 [0118] Figure 9A depicts a plan view of a bioabsorbable stent support tube, which shows various components, nested hoop / ring structure member 28, meandering / sinusoidal strut members 38, 16 and through the end ring member contacting each member at the changed structure is connected to an annular ο- 6. 图9B示出了如图9A中以膨胀构型示出的支撑管结构支架的斜视图。 9B shows a perspective view of the support structure of the stent of FIG. 9A tube to the expanded configuration illustrated.

[0119] 图1OA示出了如图9A中所绘的可生物吸收支架的连接结构6,其示出了所制造的连接状态;图1OB和IOC处于部分膨胀的状态,图1OD处于充分膨胀状态。 [0119] FIG 1OA illustrates a connection structure depicted in FIG. 9A bioabsorbable stent 6, showing a connection state produced; state in FIG. 1OB IOC and partially expanded, fully expanded state in FIG. 1OD . 如所示出的,当支架膨胀时伸缩空隙形状改变。 As shown, the shape of the gap changes when the telescopic expansion of the stent.

[0120] 图1lA描绘了非膨胀的另一可生物吸收支撑管支架设计的平面图,其示出了支柱部件之间连接的另一单·元结构并包括端环结构。 [0120] FIG. 1lA depicts a plan view of another unexpanded tube support bioabsorbable stent design, which shows another connection between the single-cell structure and includes a side strut member ring structures. 图1lB为膨胀构型的图11A。 FIG 1lB is expanded configuration of FIG. 11A. 图1lC示出了处于膨胀状态下的在膨胀气囊式导管上展开的图11A。 FIG 1lC in FIG. 11A shows the deployed expandable balloon catheter in the expanded state.

[0121] 图12A描绘了可生物吸收支撑管支架结构的另一实施方案的平面图,其示出了膨胀构型下的用于包括箍/环部件14和16的支柱部件的另一设计方案。 [0121] FIG 12A depicts a plan view of another embodiment of bioabsorbable support tube support structure embodiment which is shown in the expanded configuration comprising a further embodiment of a strut member cuff / the ring members 14 and 16. 图12B可为处于膨胀构型下的安置于气囊式导管上的图12A的可生物吸收支撑管结构。 In FIG. 12B may be disposed in an expanded configuration in Fig. 12A on the balloon catheter bioabsorbable tube support structure.

[0122] 图13A示出了这样一种可生物吸收支撑管支架实施方案,其包括置于端环处和支柱片段之间的连接部件的不透射线标记结构65。 [0122] FIG. 13A shows a bioabsorbable stent support tube embodiment comprising a radiopaque marker disposed structural member 65 is connected between the ends of the ring segments and the strut. 图13B示出了这样一个实施方案,其中不透射线材料以斜列式样65'安置,用于在该器械植入后对其进行放射照相术而识别。 13B shows such an embodiment, wherein the radiopaque material in echelon pattern 65 'is disposed, for identifying them radiography after implantation of the device.

[0123] 图14A-14D示出了可生物吸收支撑管支架的分离出的标记指示结构的其他实施方案的截面图。 [0123] FIGS. 14A-14D shows a cross-sectional view of the support bioabsorbable stent separated indicia indicating a configuration of other embodiment. 如所示出的,分离标记可被置于支撑管(14D)上、或者凹处(14B)中或多个通孔(14A和14C)中。 As shown, the separation mark may be placed on the support tube (14D), or a recess or a plurality of through holes (14A and 14C) in (14B).

[0124] 图15A和15B还示出了指示不透射线标记物65在可生物吸收的支撑管支架实施方案中的位置。 [0124] Figures 15A and 15B further illustrate radiopaque markers 65 indicate the position of the stent support tube embodiment of a bioabsorbable material. 图15C为对可生物吸收支撑管支柱实施方案中的不透射线标记指示物进行的近放射照相术。 FIG 15C near radiography performed for the embodiment of the radiopaque biodegradable schemes numerals strut support tube was absorbed.

[0125] 图16A示出了处于膨胀构型的支撑管实施方案的一端的平面图,所述支撑管实施方案包括端环部件16、锁定机构75和支撑管支柱曲折部件17。 [0125] FIG. 16A shows a plan view at one end of the expanded configuration of the embodiment of the support tube, the support tube embodiment comprising end ring member 16, the locking mechanism 75 and the support member 17 meandering strut tube. 图16B为图16A所示具有联锁锁定机构75的支撑管支架的卷曲构型。 FIG. 16B has a locking mechanism locking the support stent 75 is crimped to the configuration shown in FIG. 16A. 图16C示出了膨胀支撑管支架,其示出了应力分布,并且示出了当支撑管处于膨胀构型时锁定机构75的分离。 FIG 16C shows expandable stent support tube, which illustrates the stress distribution, and shows the separation of the locking mechanism when the support tube 75 in an expanded configuration. 图16D示出了可生物吸收支撑管支架实施方案的片段,其示出了嵌套的箍/环结构14、支撑管曲折片段17和锁定机构11或固定部件,其可针对接合进行设计方面的改变。 16D shows a fragment may be bioabsorbable stent embodiment of the support tube, which shows nested hoop / ring structure 14, the support tube 17 and the locking mechanism meandering segments or fixed member 11, which can be engaged for the design of change.

[0126] 图17A和17B描绘了支撑管支架的其它实施方案在膨胀状态下的平面图,并示出了于其各端处的脱开的锁定机构75和端环结构16。 [0126] Figures 17A and 17B depict a plan view of another embodiment of a support stent in the expanded state, and shows the locking mechanism 75 in its disengaged configuration and the end ring 16 at each end. 如所示出的,锁定机构75为凸凹部分的卡扣连接。 As shown, the locking mechanism 75 is a convex-concave portion of a snap connection.

[0127] 图18A-18F示出了可生物吸收的支撑管支架的另一实施方案的平面图和斜视图,其示出了在该器械的端环处的以及处于脱离和接合位置的锁定机构75。 [0127] FIGS 18A-18F shows a plan view and a perspective view of another embodiment of the support tube bioabsorbable stent, which shows a locking ring mechanism at the end of the instrument and in the disengaged and engaged position 75 . 所述实施方案中的锁定机构75包括卡扣球窝接合。 The embodiment of the locking mechanism 75 includes a card socket joint spiking. 图18A、18D和18E示出了不相连的锁定机构75。 FIG. 18A, 18D, and 18E illustrate a locking mechanism 75 is not connected. 图18B、18C和18F示出了处于锁定状态的锁定机构75。 FIG. 18B, 18C and 18F illustrate a locking mechanism 75 in a locked state. 图18G示出了这样一种实施方案,其中支撑管支架被安置于气囊式导管60上并且锁定机构接合以使支撑管以均一构型处于支撑管主体平面内而维持在导管上。 FIG 18G shows such an embodiment in which the support stent is disposed on a balloon catheter 60 and the locking mechanism engages the support tube to a uniform configuration is in the plane of the support tube body is maintained on the catheter. 图18H为图18G的支撑管支架16的前视图,其示出了圆形的导管60、端环16和气囊70。 FIG 18H is a front view of the support stent 16 of FIG. 18G, which shows a circular catheter 60, balloon 70 and end ring 16.

[0128]图19A描绘了支撑管支架实施方案的平面图,其示出了所制造的支撑管各端的锁定机构80的另一实施方案。 [0128] FIG 19A depicts a plan view of the embodiment of the stent support tube, showing another embodiment of the support tube at each end of the manufactured locking mechanism 80. 图19B描绘了处于卷曲位置的图19A,其示出了接合的锁定机构80。 FIG. 19B depicts a crimped position in FIG. 19A, which shows the locking mechanism 80 is engaged. 图19C示出了处于卷曲位置的锁定机构的放大平面图,图19D示出了其部分膨胀构型的不锁定状态。 FIG 19C illustrates an enlarged plan view of the locking mechanism is in its crimped position, FIG 19D shows a partially expanded configuration is not locked state. 图19E示出了锁定机构80部分接合的端环的斜视图;图19F示出了处于卷曲位置的状态而且图19G示出了安置于气囊式导管上的状态。 19E shows a perspective view of the locking mechanism 80 engages the end ring portion; FIG. 19F shows a state in a crimped position and FIG 19G shows a balloon catheter disposed on state.

[0129] 图20A描绘了处于膨胀构型的可生物吸收支撑管的实施方案中锁定机构的另一设计方案的平面图。 [0129] FIG 20A depicts a plan view of another embodiment of the design in the expanded configuration bioabsorbable support tube locking mechanism. 图20B描绘了卷曲构型下的相同平面图。 FIG. 20B depicts a plan view of the same curl configuration. 图20C为端片段的平面图,其示出了处于卷曲构型的卡扣锁定端。 FIG 20C is a plan view of an end segment, showing a snap-in locking end crimped configuration. 图20D示出了当膨胀造成锁定机构80解除锁定时图20C的端部片段。 FIG 20D shows the expansion caused when the lock mechanism 80 is unlocked segment end portion 20C of FIG. 图20E和20F分别描绘了处于膨胀构型下的具有未锁定的锁定机构90的图20C的支撑管支架的斜视图,以及处于卷曲构型的具有锁定的锁定机构90的图20C的支撑管支架的斜视图。 FIGS. 20E and 20F depicts a perspective view in FIG. 90 has unlocked the locking mechanism in the expanded configuration the support tube bracket 20C, and at 90 of FIG coiled configuration with a locking a locking mechanism support tube bracket 20C of the oblique view. 图20G示出了被安置于气囊式导管上的图20A-20F的支撑管支架。 FIG 20G shows is disposed on a balloon catheter stent support tube of FIG. 20A-20F of.

[0130] 图21描绘了置于人拇指与食指之间的所制造的可生物吸收支撑管支架的照片,其表现出器械的柔性。 [0130] FIG. 21 depicts photographs biologically produced between thumb and index finger is placed human absorption bracket support tube, which exhibits a flexible instrument. 如可以看到的,可存在相当大的柔性。 As can be seen, there may be considerable flexibility.

[0131] 由于缺乏质量密度或没有信号,实施方案的聚合物植入物几乎不可检测。 [0131] Due to a lack of quality or no signal density, polymer implants embodiment hardly detectable. 因此,所述实施方案可包括不透射线标记,如不透射线的点。 Accordingly, the embodiments may include radiopaque markers, such as radiopaque dotted lines. 所述点可通过将膏状不透射线材料施用于该支架支柱部件之中或之上的铆状凹陷处或贮藏器而产生。 The point may be formed by a radiopaque material paste is applied to the rivet-like member in the stent struts or on the receptacle or recess is generated. 如所示的,沉积于该支架上的不透射线的点的规则式样将有利地有助于使所述植入物位置的放射线检测容易。 As shown, the point rules pattern deposited on the carrier radiopaque will advantageously contribute to the radiation detecting the position of the implant easy.

[0132] 在一个支架实施方案中,该支架包括一个可卷曲的聚合物支撑管,其可通过用于血管植入的气囊递送体系被插入。 [0132] In one embodiment of the stent, the stent comprising a rollable polymer support tube, which may be the vascular implant is inserted through the balloon delivery system used. 然而,该支撑管支架的柔性塑性可导致在用于血管插入或送递的载体体系上的卷曲构型放松。 However, the flexible plastic support tube of the stent may result in the carrier system for delivery of a blood vessel or inserting a curled configuration to relax. 因此,该卷曲支架易于发生“移位”,从气囊式载体目的位置移开或变得完全松散。 Thus, the crimped stent prone to "shift", the carrier is removed from the balloon become completely loose or destination. 因此,在优选实施方案中,向这样的聚合物器械如支撑管提供一种保护机构,用于保护以避免支架在被置于或安装在递送体系上时以及在卷曲器械展开至管状器官中想要的位置期间发生意外开口。 Thus, in a preferred embodiment, the polymer to such devices as a support tube to provide a protection mechanism for protecting the stent and expand in order to avoid crimping to the tubular organ instrument when placed on a delivery system or the like mounted accidents during opening position wanted. 本文公开了可与医疗器械使用的多种保护机构。 Disclosed herein are various protection mechanisms that can be used with medical devices. 保护机构可设计成与圆周的远和近端环支柱(第二曲折支柱部件)相邻。 Mechanism may be designed to protect the distal and proximal ring adjacent to the circumference of the struts (second meandering strut member). 在具体实施方案中,该支架现已装备了锁定工具以使曲折结构保持在安全夹紧的位置,从而避免结构扭曲并用于该器械的安全展开。 In particular embodiments, the stent has been equipped with a locking means to secure that the meander structure remains in clamped position, so as to avoid distortion of the structure and deployment of the instrument for the safety. 此外,锁定装置可避免塑性支架的卷曲构型在操作期间从载体体系上松开。 Further, the locking device can be avoided coiled conformation plastic stent is released from the carrier during operation of the system. 锁定机构受结构相干的设计和/或所加入的摩擦特性影响,锁定机构可被相互的压力配合而激活。 Locking mechanism by coherent structure design and / or impact of the added friction characteristics, the locking mechanism can be activated in each press fit. 根据一种实施方案,锁定机构的摩擦力可受选择性改性的塑性组合物影响,其中离子型或非离子型添加剂物质可用于确保支架的卷曲构型。 According to one embodiment, the locking mechanism can be influenced selectively friction-modified plastic composition, wherein the ionic or non-ionic additive materials can be used to ensure that the configuration of crimped stent.

[0133] 在具体实施方案中,该支架使用多种设计方案——包括位于或接近远端和近端的卡扣部件——来锁定在递送体系的载体部件上处于卷曲位置的支架。 [0133] In a particular embodiment, the stent using a variety of designs - snap member including at or near the distal and proximal ends - to lock the stent in its crimped position on the carrier member delivery systems. 在该实施方案和其它实施方案中,可设计一种或多种卡扣结构,置于支架结构的曲折支柱部件的末端或者也可置于支架结构内的某些重复位置。 In this embodiment and other embodiments may be designed with one or more locking structures, placed at the end of the meandering strut member or the support structure may be placed in some position within the frame structure repeated. 如曲折构型中所想要的,锁定机构提高了支撑管的保持力。 The zigzag configuration desired, the locking mechanism increases the holding force of the support tube. 相邻的卡扣锁定部件被设计为连续的,或者附着到第二曲折或环/箍结构上或者其一部分上;并且有效地成形以接合并锁上处于卷曲位置的该支架器械的各端,从而提供足够的保持力来使支架保持在沿器械的纵轴的位置并维持其直径均一。 Adjacent snap locking member is designed as a continuous, meander or attached to the second or ring / hoop structure or portion thereof; and effectively formed at each end of the stent to engage and lock the instrument in a crimped position, thereby providing sufficient holding force to maintain the stent in position along the longitudinal axis of the instrument and to maintain a uniform diameter. 在某些实施方案中,器械膨胀后,末端曲折部件可形成用于提高——例如支撑管的——箍强度的完全伸直环。 In certain embodiments, after expansion of the device, the tip member may be formed for improving the winding - e.g. support tube - fully extended hoop strength.

[0134] 如以上所述,可向该器械提供一种锁匙构型部件形式的结构锁定工具,其中该设计类似于卡扣球套接合型联锁工具;在一个实施方案中,提供了一种或多种用于形成膨胀构型的箍或环状式样的嵌套的曲折部件结构。 [0134] As described above, the keys may be to provide a device configuration tool member in the form of a locking structure, wherein the card-like design engaging spike sleeve type interlocking means; In one embodiment, there is provided a expanded configuration for one or more hoop or cyclic member zigzag pattern of nested structures.

[0135] 该支架实施方案可以多种方式构成。 [0135] The holder may be configured in various ways embodiment. 例如,一种支架实施方案可使用卡扣形式的端部环型锁定位置,其中腕臂形或指状支柱部件当在支撑管的曲折构型锁上时在相邻的反压力支柱表面上紧紧地配合。 Immediately adjacent the surface of the strut when the counter-pressure end ring a locked position, wherein the finger-shaped or cantilever strut member in a meander configuration when the support tube locked e.g., a stent embodiment may be used in the form of a snap tight fit. 在另一个实施方案中,锁定工具包括这样一种指状腕臂延伸,其以卡扣方式接合地滑行于塑性·支架支柱部件的相邻部分的曲度匹配表面部件上。 In another embodiment, the locking means comprises a finger extending cantilevers which snap-engage in a sliding manner on the curvature of the mating surface portion of the plastic part adjacent to the stent-strut member. 在该实施方案中,定位机构作为一种破裂或摩擦装置起作用,其产生了足够的摩擦力以使支架端保持在卷曲位置。 In this embodiment, the positioning means as a function rupture or friction means, which generates a frictional force sufficient to crimp the stent held in the end position. 另一备选锁定工具以锁定状态下的球窝接合的卡扣锁定工具示出。 In another alternative snap locking means in a locked state of the ball engaging the locking means is shown.

[0136]另一种备选机构为这样一种卡扣锁定装置,其中该腕臂实施方案利用在相邻支柱部件上形成的切口接收部容纳腕臂的尖端部件。 [0136] An alternative mechanism is a snap-locking device, wherein the cantilever embodiments received by the notched portion is formed on the receiving member adjacent strut tip of the cantilever member.

[0137] 在一个实施方案中,该医疗器械的结构锁定工具可被设计成锁匙或球窝接合构型,其中相对定向的腕臂钩型联锁工具处于锁定和不锁定位置。 [0137] In one embodiment, the structure of the medical device may be designed to lock the tool or keys ball joint configuration, the interlocking cantilever hook tool wherein the relative orientation in the locking and non-locking position.

[0138] 在另一个实施方案中,可向该医疗器械提供以锁匙构型成形的结构锁定工具,其中该设计类似卡扣楔形榫头型联锁工具。 [0138] In another embodiment, the keys may be provided to the configuration of the locking means shaped to the configuration of medical device, wherein the design is similar to a dovetail-type interlocking snap tool.

[0139] 该锁定工具能够以接近或位于支架实体的一端或两端部件的卡扣特征的形式提供,从而使得其在递送至治疗目标区域期间可保持在载体工具上的原位置,直到或除非在植入时的展开期间膨胀载体体系被刺激以脱离该器械。 [0139] The locking means can be provided in the form of snap features near or at one or both ends of the member support entity, such that it during delivery to the treatment target region may be maintained at the original position on the tool carrier, until or unless during implantation deployed expandable carrier system is stimulated to disengage the instrument. 在展开期间,锁定机构可彼此统一地脱离。 During deployment, the locking mechanism can be uniformly from one another. 在一个实施方案中,该锁定机构可充分伸展从而使得在植入一例如血管的腔壁或其它目标区域一后在纵向曲折支架部件的一端或两端处的连接稳定器成环。 In one embodiment, the locking mechanism can be fully extended so that the implant in a cavity wall, for example, a blood vessel or other target area after a connecting ring at one or both ends of the longitudinal stabilizer zigzag stent member.

[0140] 在一个实施方案结构中,曲折支柱彼此交替。 [0140] In one embodiment the program structure, meandering struts alternate with each other. 第一曲折支柱和第二曲折或小圈支柱部件两者都通过位于相邻支柱间的交叉点处的多种形状的特殊连接器而保持于彼此卷曲构型以及膨胀或植入构型的位置。 A second member both the pillar and the first meander or zigzag struts are kept small circle curled configuration to one another and expanded or implanted configuration position by the special connector located at the intersections of various shapes between the adjacent legs . 各所述交叉连接器或其选定数目可重复使用。 The number of each of the selected cross-connect, or the reusable. 这些连接部件能保持支架实施方案的曲折支柱处于规则间隔位置。 These connecting members can be maintained meandering struts in stent embodiment of regularly spaced position. 这些连接器意欲经受由最初管形到位于送递球形物/插入器械上紧紧卷曲位置再到伸展膨胀构型的变化。 These connectors are intended to be subjected to a first tubular delivery bulb positioned / inserted into the instrument and then extended position tightly curled expanded configuration changes. 所述支撑管支架的伸展压迫和晶化支柱部件以及箍/环,形成环状并且整体为圆柱形或锥形。 Said support tube extending bracket oppression and crystallization strut member and hoop / ring formed annular and has an overall cylindrical or conical. 支柱连接部件或连接器可以重复式样排列以稳定和连接相邻曲折支柱部件。 Or the strut connecting the connecting member may be arranged in a repetitive pattern and a stable strut member connecting the adjacent turns. 该设计意欲使弹性柔性曲折支柱保持位于管状支架构造中。 This design is intended to maintain the resilient flexible meandering strut positioned tubular stent configuration.

[0141] 在另一个实施方案中,提供了一种冷却工具或条件,用于将塑性支架固定并稳定在卷曲的锁定住的载体体系上,从而提高送抵体系的可靠性。 [0141] In another embodiment, there is provided a tool or cooling condition for the plastic bracket and the stable locking of the curled live carrier system, thereby improving the reliability reach the system.

[0142] 在另一个实施方案中,该医疗器械包括这样一种聚合物支架结构,其可在展开时——例如在气囊膨胀时——的应变作用下定向和/或晶化,以改善其机械性能。 [0142] In another embodiment, the medical device comprising a polymeric support structure, which may be deployed when - for example, when the airbag is inflated - strain effect of orientation and / or crystallization, to improve its Mechanical behavior. 这些机械性能包括但不限于对压缩的抵抗力、反作用、弹性。 These mechanical properties include, but are not limited to, resistance to compression, reactive, elastic.

[0143] 在另一个实施方案中,该医疗器械由在体内可降解的聚合物或聚合物组合物制备,由所述降解得到的聚合物副产物包括具有对宿主具有极低免疫原性或基本上无免疫原性的“友好的”或生物相容的化合物,例如无显著肉芽组织可被刺激以在血管壁中生长。 [0143] In another embodiment, the medical device having a very low immunogenicity in vivo host prepared from biodegradable polymer or polymer composition, obtained by the degradation byproducts or polymers having substantially comprises a non-immunogenic "friendly" or biocompatible compound, e.g. no significant granulation tissue can be stimulated to grow in the vessel wall.

[0144] 在又一个实施方案中,该医疗器械包括具有缓慢降解动力学的聚合物,这在植入位点处可避免组织过载或其它炎性反应。 [0144] In yet another embodiment, the medical device comprising a polymer having a slow degradation kinetics, which may be at the site of implantation to avoid overloading or other tissue inflammation.

[0145] 在一个实施方案中,医疗器械最小可具有临床上足以对抗植入后的移位或降解以及导致内皮化的30天原位保留。 [0145] In one embodiment, the medical device may have a minimum degradation or displacement sufficient to counter the 30-day clinical implant in situ endothelialization results in retention.

[0146] 示例性医疗器械可结构成形以提供改变植入部位并与之一致的能力,并且提供使局部组织的正常复原的能力。 [0146] Exemplary medical devices may be shaped to provide structure to change the site of implantation and with the same capacity, and so provide a restoring normal ability to local tissue. 例如,该医疗器械可由固体聚合物状态过渡变为“橡胶状”,并使外科手术相对于例如金属支撑管如不锈钢支撑管更容易。 For example, the medical device may be a solid polymer state transitions to "rubbery", for example, is easier and surgical support tube with respect to the metal such as stainless steel support tube. 变形状态越高,赋予该器械结构部件的强度越高。 The higher the deformed state, the instrument impart higher strength structural member.

[0147] 在某些实施方案中,该聚合物组合物可包括可以占组合物约70重量% -95重量%或约70重量% -80重量%的量存在的基质聚合物。 [0147] In certain embodiments, the polymer composition may comprise the composition may comprise from about 70 wt% to 95 wt%, or about 70% by weight of the matrix polymer present in an amount of 80% by weight.

[0148] 在一个实施方案中,该聚合物制剂可包括约70重量%的聚L-丙交酯(约2.5-3IV)与聚L-丙交酯-共-TMC (70/30 w/w) (1.4 至1.6IV)。 [0148] In one embodiment, the polymer formulation can comprise from about 70 wt% of poly L- lactide (about 2.5-3IV) with poly L- lactide - co -TMC (70/30 w / w ) (1.4 to 1.6IV).

[0149] 在另一个实施方案中,该聚合物制剂包括70重量%的三嵌段聚L-丙交酯-共-PEG(99/01) (2.5-3IV)与聚L-丙交酯-共-TMC(70/30 w/w) (L 4 至L 6IV)。 [0149] In another embodiment, the polymer formulation comprises 70% by weight triblock poly-L- lactide - co -PEG (99/01) (2.5-3IV) poly L- lactide - total -TMC (70/30 w / w) (L 4 to L 6IV).

[0150] 在一个实施方案中,该聚合物组合物可包括一种约70重量%的二嵌段聚L-丙交酉旨-共-PEG-MME (95/05) (2.5-3IV)与聚L-丙交酯-共-TMC (70/30 w/w) (1.4 至1.6IV)的制剂。 [0150] In one embodiment, the polymer composition may include one about 70 wt% of diblock poly-L- lactide unitary purpose - co -PEG-MME (95/05) (2.5-3IV) and poly-L- lactide - co -TMC (70/30 w / w) (1.4 to 1.6IV) formulation.

[0151] 一个可生物降解的医疗器械的一个实施方案包括这样一种基质聚合物,其包括例如聚L-丙交酯或聚D-丙交酯、改性共聚物如上文所述的聚L (或D)-丙交酯-共-碳酸亚丙酯或者聚L(或D)-丙交酯-共-ε -己内酯。 [0151] one embodiment of a biodegradable medical device comprising a polymer matrix, including, for example poly-L- lactide or poly-D- lactide, as described above, the modified copolymer poly L (or D) - lactide - co - propylene carbonate or poly L (or D) - lactide - co - [epsilon] - caprolactone.

[0152] 聚合优选通过D和L异构体形式的嵌段聚合进行,从而获得这样一种聚合物外消旋部分,其增强了由一般无定形构型到与膨胀相关的伸展或应变引起的聚合物部分晶体重排的转变。 [0152] The polymerization is preferably carried out by polymerization of the D and L isomeric form of a block, so as to obtain a polymer in racemic outer portion to enhance the expansion of the general configuration associated with amorphous stretching or strain-induced rearranged polymer transformation part of the crystal. 机械性能相应地由可卷曲柔性变化到箍形延伸的刚性,最特别的是上述改变在第二曲折支柱上嵌套安置的和末端安置的环或箍的膨胀过程中出现。 Mechanical properties change by a crimped flexible to rigid hoop extending, most particularly above changes nested disposed on the second end of the expansion process and the meandering strut ring or cuff disposed in a corresponding manner.

[0153] 在一个实施方案中,药物组合物可通过例如以下方式混入聚合物:将该组合物与聚合物在器械挤出成型之前混合,或将该组合物接枝到聚合物活性位点上,或将该组合物涂覆于器械上。 [0153] In one embodiment, the pharmaceutical composition may be incorporated into the polymer, for example, by the following manner: the composition with the polymer prior to extrusion mixing device, or the polymer composition is grafted onto the active site or applying the composition to the instrument.

[0154] 医疗器械可包括可用于植入的任何聚合物医疗器械,包括支撑管、移植物、支撑管移植物、合成血管移植物、分流器、导管等。 [0154] Medical devices may comprise any polymer can be used in implantable medical devices, including the support tube, the graft support tube graft, a synthetic vascular grafts, shunts, catheters and the like.

[0155] 示例性医疗器械可为一个支撑管,其用第一曲折/正弦曲线部件结构成形并具有大量当膨胀时包括环状结构部件的嵌套第二部件。 [0155] Exemplary medical devices may be a support tube, which is formed with a first meandering / sinusoidal member structure and a second member having a large cyclic structure, including nested member when expanded. 该支撑管也可包括接合结构,用于帮助卷曲并维持卷曲状态以进入例如动脉或静脉,并且能原位膨胀和适应血管内腔,以在受损位点处重建血管的连续性。 The support tube may also include engagement structure, and to help maintain the crimped into the crimped state, for example, an artery or vein, and can adapt to the blood vessel lumen and expanded in situ to rebuild the continuity of the vessel at the damaged site. 在另一实施方案中,该支撑管可成形以具有不同的排列、单元结构或设计,从而使其在装入时可卷曲,并且在生理条件下一旦展开可膨胀、具有柔性,但也具有抗压缩力或回弹力。 In another embodiment, the support tube may be shaped to have different arrangement, construction or design unit, so that it can be crimped when loaded, and once deployed expandable under physiological conditions, with a flexible, but also has anti compressive force or resilience. 此外,膨胀植入物可表现出机械性能,例如一定程度的刚性和相应的柔性,从而避免脱位或移位。 In addition, the expansion of the implant may exhibit mechanical properties such as a degree of rigidity and flexibility corresponding to avoid dislocation or displacement.

[0156] 不同的可生物降解的聚合物支撑管和/或支撑管壁实施方案具有不同的构型。 [0156] Different biodegradable polymer support tube and / or the support wall embodiments having different configurations. 例如,该支撑管为一种包括这样一种支架的管状结构,其中支柱部件被设计成使血液流过各部件之间的开放空间。 For example, the support tube comprising a tubular structure such as a stent, wherein the strut member is designed so that the blood flow through the open space between the components. 特别地,该曲折支柱被如此间隔从而使得相邻组织表面中的大部分仍能与血液保持接触。 In particular, the meandering struts are spaced such that adjacent tissue so most of the blood still remains in contact with the surface. ,特定的支撑管设计部件包括取决于待展开的支撑管的大小的不同的径向和纵向参数。 The specific supporting member comprises a tube design depends on the size of the support tube to be expanded radially and longitudinally different parameters. 可改变支撑管构造,例如分叉或成形以便于进一步展开到其它远离最初植入物位点的血管。 Support tube configuration may be varied, for example, bifurcated or other shape so as to expand away from the original site of the implant to the vessel further.

[0157] 支撑管可含有用侧分枝修饰的均一的柔性支架。 [0157] support a side branch tube may comprise modified homogeneous flexible stent. 因此,该支撑管在原位最初展开后,第二支撑管可通过第一支撑管的内腔壁被插入。 Thus, the support tube in situ after initial deployment, the second support tube through the lumen wall of the first support tube is inserted.

[0158] 在一个实施方案中,可修饰该医疗器械以使其包括一种不透射线的或半透射线的材料用于在展开后探测其位置,或者胜于确定长期使用出个月或2年)的效果。 [0158] In one embodiment, the medical device may be modified to include a non-radiopaque material or semi-rays for detecting its position after deployment, rather than determining the long-term use or a month, or 2 years) effect. 可使用不同类型的修饰,例如支架的散开或点标记。 You may use different types of modifications, for example, marked point spread or stent. 因此,该不透射线材料能够以混合物的形式或以共价键合组分的形式被直接混入到最初塑性组合物中。 Thus, the radiopaque material can be in the form of a mixture or in covalently bonded form is mixed directly into the components of the first plastic composition. 或者,该不透射线材料可被置于在支架之上或之内的规则分布的多个具体的点贮藏器中。 A plurality of specific points or receptacle, the radiopaque material may be placed on the stent or within the regular distribution. 或者不透射线或半透射线的材料可作为支架上的薄涂层的部分使用。 Or a radiopaque material or semi-rays may be used as part of a thin coating on the stent.

[0159] 因此,通过电子致密或X-射线折射标记物所对组织植入物质进行的对比检测增强是有利的。 [0159] Thus, the contrast of the detected tissue implant material made by electron-dense marker or X- ray diffractometer enhancement is advantageous. 所述标记物可存在于充满由已知材料制备的不透射线组合物的可生物降解点贮藏处中,以折射X射线,从而在摄影图像中变得可见。 The marker may be present in a radiopaque filled compositions may be prepared in known biological degradation of the material at the storage point to the X-ray refraction, so that it becomes visible in the photographic image. 合适的材料包括但不限于10-90%的可包埋于可生物降解部分的不透射线化合物或微粒中,特别是置于多种位于预形成的聚合物支架支柱部件的杯状贮藏器中的膏状组合物的形式。 Suitable materials include, but are not limited to 10-90% may be embedded within a biodegradable microparticle radiopaque moiety or compound, in particular cup-shaped receptacle disposed more strut members positioned preformed polymer scaffold in the form of paste composition.

[0160] 不透射线化合物可选自不透X射线的化合物或折射X射线的化合物,如金属颗粒或盐。 [0160] The radiopaque compound may be selected from X-ray opaque compound or compounds refracted X-rays, or particles such as metal salts. 合适的金属标记物可包括纯形式或有机化合物形式的铁、金、胶体银、锌、镁。 Suitable labels may include pure metal form or in the form of an organic compound of iron, gold, colloidal silver, zinc, magnesium. 其它不透射线材料为钽、钨、钼/铱、或钼。 Other radiopaque material is tantalum, tungsten, molybdenum / iridium, or molybdenum. 不透射线标记物可由一种或多种上述可生物降解聚合物的结合剂组成,所述聚合物例如PLLA、PDLA, PLGA、PEG等。 The radiopaque markers may consist of one or more of the above biodegradable polymer composition of the binding agent, e.g. a polymer PLLA, PDLA, PLGA, PEG and the like. 为了获得合适的标记材料共混物,溶剂体系包括丙酮、甲苯、DMSO等中的两种或多种。 In order to obtain a blend suitable marking material, the solvent system comprises two or more of acetone, toluene, DMSO, and the like. 此外,标记物贮藏处可用于放置选自PPAR激动剂、留族化合物、mTOR抑制剂、神经钙蛋白抑制剂等家族的抗炎药。 In addition, the marker may be used to place the selected storage PPAR agonists, leaving family compounds, mTOR inhibitors, calcineurin inhibitors and other anti-inflammatory agents. 在一个含有不透射线标记物的实施方案中,含铁化合物或包封铁的颗粒与PLA聚合物母体交联,以产生可注射或以其它方式置于聚合物支柱部件所含的合适中空贮藏器中的膏状物质。 In an embodiment comprising a radiopaque marker, the iron compound particles to the PLA polymer, or a crosslinked matrix encapsulated iron, to produce an injectable or otherwise placed in a suitable storage of the hollow strut member contained in the polymer vessel material paste. 使所述杯状贮藏器形成这样的尺寸即使其位于支架支柱部件的宽度内。 The cup-shaped receptacle formed within the width dimension even if such a stent strut member located. 重金属和重稀土元素用于多种化合物中,例如亚铁盐、有机碘物质、铋或钡盐等。 Heavy metals and heavy rare earth elements used in a variety of compounds, such as ferrous salts, organic iodine species, bismuth or barium salts. 另外的实施方案可利用天然包封的铁颗粒如铁蛋白,其可还通过交联剂进一步交联。 Further embodiments may utilize naturally encapsulated iron particles such as ferritin, which may also be further crosslinked by a crosslinking agent. 此外,铁蛋白胶体可通过与低浓度(0.1-2%)的戊二醛交联构成。 Further, the colloid may be formed by ferritin with a low concentration (0.1-2%) glutaraldehyde crosslinked. 不透射线标记物可以多种方式被使用并保持于聚合物中。 The radiopaque markers may be used in various ways and held in the polymer. 例如,该标记物的流体或膏混合物可填充于注射器中并通过针尖缓慢注射入可生物降解的支撑管支架的预形成的空穴或杯状凹陷处。 For example, a fluid or paste mixture of the marker may be filled in a syringe and injected through a needle into a slowly biodegradable stent support tube holes or pre-formed cup-shaped depressions. 流体混合物中所含的溶剂可将标记材料结合到空穴壁上。 The solvent fluid contained in the mixture may be incorporated marker material into the cavity wall. 含有不透射线标记点的支撑管可在加热/真空下干燥。 Support tube containing a radiopaque marker may be heated / dried under vacuum. 植入后,可生物降解结合剂可降解为可被身体吸收/排出的简单分子。 After implantation, the binding agent is biodegradable to simple molecules which may be absorbed / discharged body biodegradable. 因此,不透射线材料在接近首先被植入的区域中将变得分散。 Thus, radiopaque material to become dispersed in the region close to the first implanted.

[0161] 定时地原位测定支架机械性能,测定反冲力的保持和再狭窄组织的存在。 [0161] timing of the stent in situ measurement of mechanical properties, determine the presence holding recoil and restenosis tissue. 类似地,支架聚合物生物降解和新陈代谢可通过测量回声的产生和组织组成的定量改变而评估。 Similarly, the biodegradable polymer scaffold alter metabolism and quantified by measuring the echo generation and organizations of the evaluation. 局部机械性能可通过震动学(palpography) (6个月;2年)来评估。 Local mechanical properties can be obtained by Vibration Technology (palpography) (6 months; 2 years) evaluated. 聚合物降解过程中的质量随时间的下降可通过0CT(6个月;2年)评估。 Degradation of the polymer quality by lowered over time 0CT (6 months; 2 years) evaluation. 二元再狭窄可用MSCT(18m)定量测定。 Two yuan restenosis available MSCT (18m) quantitatively. 实验证据表明了可生物降解的可吸收支架用于例如支撑管中时的优点。 Experimental evidence indicates that the biodegradable stent may be used to advantage when the absorbent support tube, for example. 已发现,在急性递送和适应性方面,该支架的作用类似金属药物洗脱支撑管(DES)。 It has been found, in the delivery of acute and adaptability, metal-like effect of the drug eluting stent support tube (DES). 然而,已发现定位的支架被自然吸收并充分代谢。 However, it has been found that the positioning of the stent is fully natural absorption and metabolism. 因此,可为管状支撑管形式的可生物吸收的支架被完全代谢,不留下永久性的植入物并且留下已愈合的自然脉管或组织。 Thus, the tubular support may be a form of a tube may be bioabsorbable stent is completely metabolized, leaving no permanent implant and the tissue or vessel is leaving the natural healing. 本发明的支架可与CT成像相容。 Stent of the present invention may be compatible with CT imaging.

[0162] —种用于制备不例性医疗器械的方法,包括:制备一种含有或不含有一种或多种药物物质的合适聚合物组合物;成型或挤出该聚合物组合物以使得植入器械结构上成形。 [0162] - methods for the preparation of Example does not medical devices, comprising: preparing a suitable polymer or may not contain one or more composition of the drug substance; molding or extrusion of the polymer composition such that device structure formed on the implant. 如果是支撑管,则形成管状结构并且随后——例如在激光的帮助下——将其切割以形成所想要的式样。 If the support tube, the tubular structure is formed and subsequently - for example with the aid of a laser beam - it is cut to form a desired pattern.

[0163] 在一个实施方案中,一种制造该医疗器械的方法包括:制备一种可生物降解的聚合物结构;设计所述聚合物结构以成形来植入患者体内;用激光将所述结构切割成这样的成形式样,即使得可通过开口横穿器械并且便于该器械的卷曲。 Method [0163] In one embodiment, a method of manufacturing the medical device comprising: preparing a biodegradable polymer structure; the polymer structure designed to be implanted in the patient molding; said laser structure with such shaped cut pattern, even when the opening may be obtained by a traverse device and facilitate curling of the instrument. 优选,成样的结构含有上述用于稳定卷曲的器械以使之安全地保留在载体/植入物体系上的锁定工具。 Preferably, the structure containing the sample into a safe instrument for stabilizing curling so as to retain the locking means on the carrier / implant system.

[0164] 在另一个实施方案中,用于帮助卷曲和装入支架构型的锁定装置的闭合方式,还可通过将生物相容的非离子型或离子型试剂加入到支架或支架组合物中或者以层或移植物形式加入而被化学改性或增强。 [0164] In another embodiment, the crimping and to help mount the closure embodiment of structure of the locking means, but also by the biocompatible nonionic or ionic agent is added to the composition in the stent or stent It has been chemically modified or added or enhanced in the form of layers or graft. 这些经改性的阴离子、阳离子或非离子层可为均一的或者可被极细微点刻于联锁表面上。 These modified anionic, cationic or nonionic layer may be uniform or may be engraved on a very fine point locking surface. 也可为表面活性剂的阳离子型或阴离子型试剂的剂量水平范围可为0.01-10重量%。 It can also be dosage levels of the cationic or anionic surfactant agent may be from 0.01 to 10 wt%. 所述离子型试剂的外部施用优选用于原位膨胀后的容易溶解移出。 The external administration preferably ionic agents for the removal is easily dissolved in situ expansion. 非离子试剂的低剂量水平适合用于提高摩擦相互作用,特别是介于锁定机构部件之间的摩擦相互作用。 Low dose levels of non-ionic agents are suitable for improving frictional interaction, in particular between the locking mechanism the friction between interacting components. 优选这样的非离子型试剂,其由FDA批准可以0.05-2.5%的剂量水平使用。 Preferably such a non-ionic agents which can be approved by the FDA to use 0.05 to 2.5% dosage level. 摩擦力提高的支架或者特别为相互联锁表面的实施方案,提供了改性层的非离子型掺杂。 Friction or improve stent are interlocked particular embodiment the surface is provided a non-ionic modified layer doped. 合适的非离子型试剂可选自化学品,例如乙氧基化脂肪胺、脂肪酸酯以及单酸甘油酯和甘油二酯。 Suitable non-ionic agents can be selected from chemicals, such as ethoxylated fatty amines, fatty acid esters and mono- and diglycerides.

[0165] 尽管参照具体实施方案已对本发明特别示出并描述,但将理解的是,以上所公开以及其它的特征和功能的变型、或者它们的替换物,可根据需要结合入多种其它的不同系统或应用。 [0165] While reference to specific embodiments have been particularly shown of the present invention is described, it will be understood that the above-disclosed and variations other features and functions, or their alternatives, may be into a variety of other in accordance with the needs of different systems or applications. 同样,本文中多种可由本领域普通技术人员随后作出的目前无法预料的或意料之外的替换物、变化、变型或改进也将意欲包含于所附权利要求中。 Similarly, various herein by one of ordinary skill in the art subsequent to the presently unforeseen or unanticipated alternatives, variations, modifications or improvements are also intended to be encompassed within the appended claims.

Claims (22)

1.一种可生物吸收的柔性支架,以圆周形式绕纵轴形成这样一种管,所述管具有近开口端以及远开口端,并且可卷曲且可膨胀,而且具有膨胀形式的式样形状,该支架包括: 由所述管的所述近开口端螺旋状延伸到其所述远开口端的第一多部件支柱单元结构; 由所述管的所述近开口端螺旋状延伸到其所述远开口端的第二多部件支柱单元结构;以及位于所述多部件支柱单元结构之间的嵌套的箍结构; 其中,各部件由所述管的所述近开口端螺旋状延伸到其所述远开口端时,所述第一多部件支柱单元结构的部件相对于第二多部件支柱单元结构的部件成120°至180°。 A bioabsorbable flexible stent, formed circumferentially about a longitudinal axis form a tube, the tube having a proximal open end and the open distal end, and may be crimped and expanded, and the expanded form having a pattern shape, the stent comprising: by the proximal open end of the tube extends spirally to a first multi-cell structure which the pillar member open distal end; by the proximal open end of the tube which extends into the distal helically the open end of the second multi-cell structure pillar member; and a ferrule between the nested structure of the multi cell strut member; wherein each member of said proximal open end of the tube which extends into the distal helically end of the opening, the first member of the multi-cell structure of the strut member relative to the second multi-part unit structure pillar member to be 120 ° to 180 °.
2.权利要求1的支架,其中所述第一多部件支柱单元结构的各部件支柱单元结构的构型实质相同。 2. The stent of claim 1, wherein the configuration of the substantial part structure of each column unit cell structure of the first strut member the same plurality.
3.权利要求1的支架,其中所述第二多部件支柱单元结构的各部件支柱单元结构的构型实质相同。 3. The stent of claim 1, wherein the structural configuration of the substantial column unit cell structure of each strut member of the second plurality of the same component.
4.权利要求1的支架,其中所述第一和第二多部件支柱单元结构的各部件支柱单元结构的构型实质相同。 4. The stent of claim 1, wherein said first configuration and a configuration of substantial part of each column unit cell structure of a second multi-pillar same components.
5.权利要求1的支架,其中位于所述第一多部件支柱单元结构和第二多部件支柱单元结构之间的所述部件支柱单元结构的各相对部件的构型实质相同。 5. The stent of claim 1, wherein the relative configuration of the substantial part of each pillar cell structure member located between the plurality of the first member and the second multi-cell structure strut column unit the same structure member.
6.权利要求2的支架,其中各部件形成固定的H构型。 6. The stent of claim 2, wherein each fixing member is formed of H-configuration.
7.权利要求2的支架,其中各部件形成固定的X构型。 7. The stent of claim 2, wherein the components form a fixed X-configuration.
8.权利要求2的支架,其中各部件形成固定的S构型。 8. The stent of claim 2, wherein the components form a fixed S configuration.
9.权利要求2的支架,其中各部件形成固定的8构型。 9. The stent of claim 2, wherein each forming member 8 fixed configuration.
10.权利要求2的支架,其中各部件形成固定的I构型。 10. The stent of claim 2, wherein the components form a fixed I configuration.
11.权利要求2的支架,还包括由所述管的所述近开口端螺旋状延伸到其所述远开口端的第三多部件支柱单元结构。 11. The stent of claim 2, further comprising by the proximal open end of the tube extends spirally to a third multi-cell structure which pillar member distal the open end.
12.权利要求11的支架,还包括由所述管的所述近开口端螺旋状延伸到其所述远开口端的第四多部件支柱单元结构。 12. The stent of claim 11, further comprising by the proximal open end of the tube extends spirally to a fourth multi-cell structure which the pillar member distal end opening.
13.权利要求12的支架,还包括由所述管的所述近开口端螺旋状延伸到其所述远开口端的第五多部件支柱单元结构。 13. A bracket as claimed in claim 12, further comprising by the proximal open end of the tube extends spirally strut member to the fifth multi-cell structure which the distal open end.
14.权利要求2的支架,其中两个多部件支柱单元结构的各个螺旋绕所述管沿左手螺旋方向绕转。 14. The stent of claim 2, wherein each of the helical configuration of two multi-column unit about the tubular member in the left-hand orbiting spiral direction.
15.权利要求2的支架,其中两个多部件支柱单元结构的各个螺旋绕所述管沿右手螺旋方向绕转。 15. A bracket as claimed in claim 2, wherein the configuration of two multi-column unit of each screw member revolves about the tube along the right-handed direction.
16.权利要求2的支架,其中两个多部件支柱单元结构的至少一个螺旋绕所述管沿左手螺旋方向绕转,另一个螺旋沿右手螺旋方向绕转。 16. A bracket as claimed in claim 2, wherein the structural units of more than two struts at least one helical member revolves around the tube in the left-handed helix direction, the other in the right-handed helical swirling direction.
17.权利要求11的支架,其中多部件支柱单元结构的所有螺旋绕所述管沿相同的方向绕转。 17. The stent of claim 11, wherein the multi-cell structure strut member all around the tube spiral orbiting in the same direction.
18.—种可生物吸收的支撑管,其包括多个由所述支撑管的近开口端螺旋状延伸到其远开口端的多部件支柱单元结构,其中,当各部件由所述支撑管的所述近开口端螺旋状延伸到其所述远开口端时,每个所述多部件支柱单元结构的部件相对于另一多部件支柱单元结构的另一部件成120°至180°,其中,所述支撑管具有位于所述多部件支柱单元结构之间的至少一个嵌套的箍结构。 18.- species bioabsorbable support tube, including the proximal open end which extends into the helical structure of the multi cell strut member distal the open end thereof by a plurality of said support tube, wherein, when each member is supported by said tube said helically extending into the proximal open end when said distal open end thereof, each member of the multi-cell structure of the strut member relative to the other member of another multi-cell structure pillar member to be 120 ° to 180 °, wherein the said support tube having at least one nested hoop structure is located between the multi-cell structure strut member.
19.权利要求18的支撑管,其中多部件支柱单元结构的各螺旋绕所述支撑管沿左手螺旋方向绕转。 19. The support tube as claimed in claim 18, wherein each of said helically wound multi-cell structure strut member in the left-hand support tube orbiting spiral direction.
20.权利要求18的支撑管,其中两个多部件支柱单元结构的各螺旋绕所述支撑管沿右手螺旋方向绕转。 20. The support tube as claimed in claim 18, wherein each of the two multi-spiral wound cell structural member support struts revolving tube in the right hand direction.
21.权利要求18的支撑管,其中多部件支柱单元结构的至少一个螺旋沿左手螺旋方向绕转,另一个螺旋绕所述支撑管沿右手螺旋方向绕转。 21. The support tube as claimed in claim 18, wherein the at least one helical spiral direction along the left-hand column unit configuration of a multi-orbiting member, other spiral orbiting around the support tube in the right-handed direction.
22.权利要求18的支撑管,其中多部件支柱单元结构的所有螺旋绕所述支撑管沿相同的方向绕转。 22. The support tube as claimed in claim 18, wherein the multi-cell structure strut member all orbiting spiral around the support tube in the same direction.
CN 200780034691 2006-07-20 2007-07-20 Bioabsorbable polymeric medical device CN101516291B (en)

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