CN103381101B - For the method and system of clamping and repairing lumen and tissue defects in vascular - Google Patents

Abstract

The present invention relates to for the method and system of clamping and repairing lumen and tissue defects in vascular.Implantable enclosed construction is conveyed using minimally-invasive technology, and suppress liquid and particulate matter from such as aneurysm or the physiology cavity of interval defect or the internal migration of opening, and suppress liquid and particulate matter and such as flow into physiology cavity or opening from associated blood vessel or chamber.The device has enclosed construction, the neck or opening of enclosed construction covering cavity and with being used for enclosed construction supports and is held in place one or more anchoring structures across cavity or opening.

Description

For the method and system of clamping and repairing lumen and tissue defects in vascular

The application is PCT Patent Application (the China national Shen for having been enter into National Phase in China submitted on June 11st, 2008 Please number be 200680047626.1, international application no PCT/US2006/040907, entitled " METHODS AND SYSTEMS FOR ENCOVASCULARLY CLIPPING AND REPAIRING LUMEN AND TISSUE DEFECTS”) Divisional application.

The cross reference of related application

This application claims the U.S. Patent application No.60/823,730 that August in 2006 is submitted on the 28th；On May 25th, 2006 The U.S. Patent application No.60/803,200 of submission；The U.S. Patent application No.60/747,400 that on May 16th, 2006 submits； The U.S. Patent application No.11/324,827 and the U.S. Patent application submitted on October 19th, 2005 that on January 3rd, 2006 submits No.60/728,052 interests, the disclosure of above-mentioned application are fully incorporated in the present invention by reference.

Inventive technique field

The present invention relates generally to the system and method using the defects of minimally-invasive technology repairing physiology inner chamber, this is lacked The defects of falling into the blood vessel or air flue of such as mammal.More particularly it relates to using the occlusion of minimally-invasive technology not Desirable opening, clamp and repair the mankind or the system and method the defects of institutional framework of animal, the defect such as artery Knurl, other vascular defects, interval defect and other tissue defects and other channel defects.

Background of invention

For closing opening and repairing the defects of anatomical lumens and tissue of such as blood vessel, interval defect and other types Physiological defect and the surgical technic of defect be high invasive.For example, need to open for clamping aneurysmal surgical method Skull, excision or the brain tissue for removing covering, clamp from extravascular and repair aneurysm, be then reassembled with tissue and close Skull.Surgical technic for repairing interval defect is also high invasive.With during this operation and in this operation Rear anesthesia, the risk for bleeding related to infection are high, and impacted tissue during operation may, it is also possible to Bu Huicun Live and continue to play a role.

Alternatively, minimally-invasive surgical technic can be used for placing locking device in opening in vivo or cavity or Across the opening or cavity, the opening or cavity are in such as vascular system, backbone, fallopian tubal, bile duct, bronchus and other air flues Deng in tissue.Generally, implantable device is guided to desired locations by delivery conduit, and such as pusher or defeated can be passed through The pushing mechanism of line sending (delivery wire) pushes through implantable device the opening of the far-end positioned at delivery conduit, so as to Deploy the device in the desired locations of intervention.Once locking device is placed on desired locations, then the locking device Separated in the state of without prejudice to the placement of the locking device or destruction surrounding structure from pushing mechanism.

Aneurysm be arterial wall in protuberance, it is typically due to caused by the reduction of arterial wall, the protuberance formed opening or Cavity and the often internal position bled with apoplexy.Generally, the purpose of minimally-invasive treatment is to prevent from gathering or formed Material in the cavities enters blood flow, and anti-Hemostatic Oral Liquid enters and accumulated in aneurysm.This is frequently by by various materials Introduce in aneurysm and realize with device.

The related risk to patient be present to aneurysmal using various suppositories and device to reduce.A kind of suppository Fluid or suspension including injectable, such as microfibrillar collagen, various polymer microspheres and polyvinyl alcohol foam.These polymerizations Agent can be (sometimes in vivo) of crosslinking, to extend persistence of the preparation in vessel location.These preparations draw frequently by conduit Enter in vascular system.After introducing, the material being introduced into forms solid space filling block in the position.Although in these preparations Some excellent short-term occlusions are provided, but many preparations are considered as allowing vascular again to lead to due to being absorbed into blood.It is all As the other materials of bristles and metal particle suspension have also been suggested and for promoting aneurysmal occlusion.Such as cyano group The polymer resin of acrylate also serves as the vascular occlusion material of injectable.These resins typically compare material with radiopaque Material mixes, or turns into radiopaque material by adding tantalum powder.It is accurate and in time place these mixtures be to Close important and extremely difficult.Once these materials are put into vascular system, they are difficult to or can not possibly received Return.

Implantable vascular occlusion metal structure is also widely known by the people and using universal.Many vascular occluding devices are with bung flange (coil) structure provides, and is made up of shape-memory material, the shape-memory material leave delivery conduit distal end it After form desired bung flange structure.The purpose of the bung flange be filling by defect or the space that is formed of damage, and be easy to it is related Autologous tissue formed embolism.Multiple bung flanges with identical structure or different structure can sequentially be implanted into single during operation In aneurysm or other vascular defects.Implantable frame structure is additionally operable to attempt before the packing material of insertion such as bung flange The wall of stable aneurysm or defect.

Technology for vascular occluding device to be delivered to target point (target site) generally includes delivery conduit and divided Disembark structure, the separating mechanism separates bung flange after bung flange to be placed on to target point from conveying mechanism.Typically by means of Using steerable seal wire (guidewire), microtubular be initially manipulated by delivery conduit enter or close to it is aneurysmal enter Mouthful.Then, seal wire is extracted out from microtubular inner chamber and replaced by implantable vascular occlusion bung flange.Before vascular occlusion bung flange Enter through and depart from microtubular, and thereby be deposited on aneurysm or other vasculars are extremely interior.It is implanted into the internal volume of cavity Vascular occluding device and safeguard that the device is vital in aneurysmal internal volume.Vascular occluding device is from cavity Migration or protrusion can interference with blood flow or neighbouring physiological structure, and cause serious health risk.

The aneurysm of known a kind of commonly referred to as " wide neck aneurysm " is deposited in terms of the placement and holding of vascular occlusion bung flange In special difficulty.Wide neck aneurysm is often referred to the artery with knurl neck or the vascular wall of the entry zone from adjacent vessels Knurl, the knurl neck or entry zone are larger compared with aneurysmal diameter, or clinically observe too wide and can not effectively protect Hold the vascular occlusion bung flange deployed using above-mentioned technology.

Bung flange or other structures are placed in the inner space of aneurysm or other defects or material not fully succeeds. Placement operation is probably laborious and tediously long, it is necessary to sequentially place a variety of dresses of such as bung flange in aneurysmal inner space Put.Generally, perform the operation longer, be related to higher from the complication risk anaesthetized, bleed, infected etc..Further, since aneurysmal Displacement structure generally incomplete occlusion opening in inner space, thus more likely occur it is former it is aneurysmal lead to again, fragment and occlusion Material can escape out of aneurysm and apoplexy be present, the risk of vessel occlusion or other undesirable complication.In addition, placing After embolization device, blood may also be flowed into aneurysm and other aberrant angiogenesis, which increase the risk of complication and Further expand aneurysm.In addition, some aneurysms, vascular and other channel defects be not very suitable for place bung flange or Other traditional locking devices.

Propose the device for maintaining vascular occlusion bung flange in aneurysm.Described in United States Patent (USP) 5,980,514 A kind of such device, the interior intracavitary of the supply vascular that is placed on outside aneurysm is which disclose so that bung flange to be maintained at Device in aneurysm cavity.The device is held in place by by the radial pressure of vascular wall.Discharged by the device And be placed on after correct position, the interior intracavitary that microtubular is inserted behind holding meanss, and the distal end of conduit is inserted and is used for Place in the aneurysm cavity of one or more vascular occluding devices.The holding meanss prevent locking device from being migrated from cavity.

Described in United States Patent (USP) 5,749,894 for closing aneurysmal another method, in that patent, such as The vascular occluding device of bung flange or braid has polymer (polymeric composition), the polymerization on its outer surface Thing is reformed or condensed to provide obstacle in original place.The polymer for example can be melted by using photoactivation, or additionally be reformed Polymer outside vascular occluding device.Then, vascular occluding device is adhered on itself at its various contact position, and And rigid integral blocks are formed in aneurysm.

It also proposed the device for bridging aneurysmal knurl neck.For example, U.S. Patent application 2003/0171739A1 is public A kind of bridge material of knurl neck is opened, it has the one or more array elements being attached on join domain and is attached to bonding pad Covering on domain and/or array element.The array element may include Nitonol alloy hoops, and the covering may include fabric, Net or other laminated structures.

U.S. Patent application 2004/008799 discloses the apparatus and method for treating vascular defect, wherein, two pieces Shape structure, or a laminated structure and a branching rod structure play a part of fixed vascular occluding device and occlusion is open.This Patent discloses the synthetic and material for listing a variety of bio-compatibles, and it can be used together with the device to promote adhesion, fibre Dimensionization, tissue growth, endothelialization or cell growth.

U.S. Patent application 2004/0193206 is disclosed at least partly aneurysmal another device of occlusion, and it is wrapped Include multiple elongated members, these parts be configured to move relative to each other so that bridge-shaped object delivery configuration and deployment configuration it Between change.Two array bridge-shaped objects are also disclosed, wherein the first array deploys inside aneurysm, the second array is outside aneurysm Deploy in portion.

Interval defect locking device is also known from.This device occlusion heart or opening or interval in vascular system Defect.Such as disclose interval locking device in United States Patent (USP) 6,077,291 and 6,911,037.Sealing or part sealing branch The bronchoscopy amount control device of tracheae inner chamber is also known, for example, see United States Patent (USP) 7,011,094.

Being currently used in the system of separation implantable device after the placement includes mechanical system, electrolysis system and hydraulic pressure system System.In mechanical system, locking device and promotion silk (pusher wire) are coupled by mechanical fastener or interlocking connector, Once device leaves the delivery conduit mechanical fastener or interlocking connector separates, so as to discharge the device.This system Example includes United States Patent (USP) 5,263,964；5,304,195；5,350,397 and 5,261,916 systems instructed.

In electrolysis system, the joint that is constructed (being usually fiber base or adhesive base) will promote silk to be connected to and close On plug device.Once place the device in desired locations, then the joint by doctor by using electric current or or heat (such as profit With laser) and electrolytically decompose.The example of this system is provided in United States Patent (USP) 5,624,449.This system has as follows Shortcoming, i.e., dissolved material or gas may be discharged to vascular system as caused by electrolysis, so as to produce potential wind to patient Danger.During the Invasive procedures of several locking devices are placed, the completion of electrolytic separation is also possible to spend ratio desired Time more times.

In hydraulic system, silk is promoted to be connected to by polymer connection on locking device.The promotion silk includes micro- inner chamber, Hydraulic injector is attached on micro- inner chamber by doctor in the proximal end of promotion silk.When applying pressure on syringe plunger, Hydraulic pressure increases and forces polymeric joint to expand and rupture, so as to discharge the device.In United States Patent (USP) 6,689,141 Describe the example of hydraulic system.

In spite of a variety of available device and system using minimally-invasive technology come inaccessible physiological defect, but these hands Art still has risk, and even if successfully occlusion opening, its result also are difficult to physiological structure recovering normal strong to it Health state.Wherein, method and system of the invention, which is intended to reduce, is used for occlusion opening and the minimum of repairing lumen or tissue defects The duration of invasive surgical and complexity, and be intended to recover the physiological structure of such as blood vessel to its normal healthy shape State.

Brief summary of the invention

The present invention, which provides, utilizes the opening in the inner chamber of the inside in minimally-invasive technology repairing subject's body or cavity Method and system.Generally, these system and method associate use extremely with such as vascular of opening or cavity, and join herein Their applications for aneurysm and other types of vascular defect are examined to be described.It should, however, be understood that the present invention's is System and method are not limited to these applications, and repair and be reconstituted in physiological inner chamber or passage or tissue available for hope Opening or cavity plurality of medical indication.

On the one hand, method and system of the invention across opening or cavity by placing enclosed construction and utilization one or more Individual anchoring structure keeps enclosed construction to repair and rebuild the inner chamber of such as blood vessel across opening, one or more anchoring structures As clamping such as aneurysmal opening or cavity in vascular and by opening or cavity from parent artery (parent Artery) the device of isolation.After the placement, the enclosed construction covers opening or cavity substantially, and is formed and existed with internal chamber wall Substantially similar substantially continuous internal chamber wall is constructed under its health status.The anchoring structure and enclosed construction substantially not with Fluid stream interference in inner chamber.Place perform the operation during or place perform the operation after and/or with system relatively, can will be various Preparation provides the preparation for repairing position, such as promoting endothelialization again and tissue growth, and adhesive, therapeutic agent, anti-hemolysis Bolt preparation etc..

On the other hand, method and system of the invention by across opening or cavity place limitation close to the defect and with this The enclosed construction and keep enclosed construction to isolate such as across opening using one or more anchoring structures that deficient cells connect Aneurysmal defect.The method and system of the present invention may additionally facilitate the contraction of each several part of defect or defect and adsorb again, and The hemostasis being easy to inside defect.On the one hand, not only recover attached in defect for treating aneurysmal method and system of the invention The 26S Proteasome Structure and Function of near load knurl vascular (parent vessel), and the material inside stable aneurysm, prevent fragment from departing from Into blood flow, and promote to reduce aneurysmal size and quality.

Intracavity operation and endovascular surgeries are commonly used to place implantable device and material with a variety of intervening modes.Blood vessel Interior guiding catheter is generally such as inserted in the vascular system of patient by femoral artery, and is directed to or is connect by vascular system The desired locations closely intervened.The other conveying mechanisms and special conduit of microtubular, pushing meanss etc. can be used for promotion will Various devices and annex are delivered to target point.Implantable device is generally detachably mounted on impeller or conveying mechanism, and And target point is navigated to by guiding catheter, deploy implantable device at the target point and them is divided from conveying mechanism From.Then, conveying mechanism is retracted by guiding catheter, and if desired, can be by it before the guiding catheter is removed Its device, annex, medicine etc. are delivered to target point.

The method of the present invention leads the device in minor diameter, feed status using the intracavitary technology of minimally-invasive Boat to desired repairing position, device has enclosed construction and one or more anchoring structures.In certain embodiments, seal wire Guided by guiding catheter and navigate to target repairing point.Then, the locking device can navigate to target repairing point and on the seal wire Expansion.In a preferred embodiment, locking device is preloaded in the distal part of delivery conduit, and the delivery conduit is dimensioned so as to For (multiple) physiology inner chamber is navigated into target repairing point.If necessary, to seal wire, delivery conduit, locking device and push away The size of the combination of moving part or separator is suitably set, and has enough flexibility and pushability, with navigation Relatively long inner chamber distance and tortuous passageway.For example, long tortuous passageway must be passed through, implantable device is delivered to brain arteries and veins Guard system, and size must be set and be configured to provide for required flexibility, pushes away by (multiple) delivery conduit and implantable device Dynamic property and guided bone.

In one embodiment, method of the invention is additionally included in the guiding nearby of physiological defect or opening and positioning in small The defects of diameter feed status closed system, the defect closed system has enclosed construction and at least two groups of anchoring structures.Generally, First anchoring structure or first group of anchoring structure contact or the close positioning of a surface and exhibition near physiological defect or opening Open.After the expansion, (multiple) first anchoring structure is radially opened and extended so that the construction of substantially circle configurations is presented, the structure Make the periphery more than enclosed construction and generally about the periphery of enclosed construction.Then, the enclosed construction across physiological defect or Opening positioning and expansion, with basic covering and inaccessible defect or opening.After enclosed construction expansion, the second anchoring structure or the Two groups of anchoring structure contacts are positioned and deployed close to the substantially relative surface of another of physiological defect or opening.Second grappling Structure or second group of anchoring structure are radially opened and extended with tissue (such as vascular wall) and (multiple) the first grappling knot The construction of substantially circle configurations is presented on the relative surface of structure, the construction is more than the periphery of enclosed construction and generally about closing The periphery positioning of structure.Anchoring structure in deployed condition preferably in contact with or closely defect or opening near in The apparent surface of chamber or tissue position, and enclosed construction preferably substantially covering be open and meet internal chamber wall to be closed or The structure and construction of defect, internal chamber wall or defect are recovered into the structure normal and healthy to its and construction.The anchoring structure Effectively serve as relative clip, the apparent surface of contact deficiency structure organization or extend to contact healthy group near defect Knit, so that enclosed construction is positioned and retained in into appropriate location across opening.

It can help to deploy defect closing by placing radiopaque mark on delivery conduit and/or defect closed system System.For example, in the distal end of the device corresponding to the first anchoring structure (when in feed status), corresponding to enclosed construction The center section (when in feed status) of device, and/or device corresponding to the second anchoring structure proximal portion (when in During feed status) one or more radiopaques marks can be set.Then, the device can be deployed in the following way：Passing through will Distal side radiopaque mark is positioned as across defect opening and in the opening close to opening or the inner space of cavity, and And the first anchoring structure of expansion；Middle radiopaque mark is positioned at defect opening, and deploys enclosed construction；With it is last Nearside radiopaque mark is positioned at the slightly outside of opening, and deploys the second anchoring structure.With locking device and/or defeated Send conduit association to use and places radiopaque and mark and be easy to being accurately positioned and deploying for anchoring structure and enclosed construction.By with Anchoring structure is positioned on the opposite face of the neighbouring inner chamber of opening or tissue and positions the closing across opening by the mode of circumference Structure, position and keep securely the closed system.The radiopaque being arranged on by checking on device is marked relative to tissue The position of defect or opening, it can place and monitored afterwards after treatment the position of closed system.

The implantable device of the present invention use enclosed construction with it is basic cover with the opening in occlusive tissue or cavity and Extend in the opening or cavity.As described below, the enclosed construction can be made up of a variety of different materials, and can be carried out a variety of Surface treatment and/or related to multiple material to provide desired characteristic for various applications.Closing knot in deployed condition The size of structure and construction be preferably at least one greater in size than such as aneurysm neck the defects of opening, so as to enclosed construction Basic covering opening upon deployment.The enclosed construction can have substantially continuous inaccessible surface region, or alternatively implement In example, the enclosed construction can have one or more openings, facilitate the use coaxial seal wire to place enclosed construction and/or just In the inside that the implantable device of auxiliary or preparation are delivered to cavity or defect after enclosed construction is placed.

In certain embodiments, the enclosed construction is semipermeable, and generally has enough radial compliances with mould The structure of imitative repaired tissue and movement (such as beating).For example, when enclosed construction is placed across aneurysm neck, the closing Structure becomes substantially continuous with vascular wall and follows the movement of vascular wall, so as to effectively repair and rebuild vascular wall and Recover intensity, structure and the flexibility of vascular wall.In a preferred embodiment, after being placed across tissue or vascular defect, the envelope Close structure and/or anchoring structure does not repair defect only effectively, and promote the ingrowing of cell and endothelialization again, so as to enter Locking device is incorporated in physiological structure and reduces the structure by one step to be weakened and returns to fault of construction or functional defect The chance of state.

The enclosed construction can be combined with reinforcement structure, or the special area of its structure on its whole surface region to be had There is reinforcement structure.For example, in one embodiment, elastic and flexible flaky material, which can be bonded to, to be had well-regulated or does not advise It is in the more rigid reinforcement structure of pattern then or associated.In one embodiment, enclosed construction is by providing structure Silk ring (wire loop) or frame structure supports with reinforcement is in its adjacent peripheral edges, and additionally or alternately, enclosed construction It may incorporate one or more anchoring structures.In one embodiment, reinforcement structure includes thimble structure, itself and one or more Anchoring structure is integrally or as the mounting structure for one or more anchoring structures.

In certain embodiments, (multiple) anchoring structure makes enclosed construction recline internal chamber wall biasing, and out of internal chamber wall The position of portion or outside is across opening or defect.In certain embodiments, multiple anchoring structures are set, and it makes enclosed construction recline Internal chamber wall biases and from the inside and outside position of internal chamber wall across opening or defect.In other embodiments, there is provided Multiple anchoring structures, it has contact or closely at least one grappling knot of the inner lumen wall near opening or defect Structure and contact or very close extra lumina wall or cavity or at least one anchoring structure of the inwall of defect in inner chamber. In one embodiment, anchoring structure circumferentially positions in the inside and outside of the inner chamber defect close to opening or defect, closing knot Structure basic covering opening or defect, effectively isolates the side of opening from opposite side and will across opening or defect location Recover to its initial closing and continuous structure inner chamber.

In certain embodiments, the anchoring structure is intended at least partly tissue or blood vessel of the contact near opening or defect The one or both sides of wall, and enclosed construction is positioned and supported across opening.The anchoring structure be usually hurtless measure and will envelope Close structure to maintain in position, the inaccessible defect is without destroying adjacent tissue or limiting the blood flow in vascular or tissue.One In individual embodiment, anchoring structure is arranged to ring or the clip structure with opening, and in the surface region of the anchoring structure Density of material is typically smaller than the density of material in the surface region of enclosed construction.The implantable device is generally under feed status The substantial cylindrical construction of minor diameter, in this case, the anchoring structure generally protrudes in the opposite direction from middle enclosed construction. During expansion, the anchoring structure is changed shape and outwardly opened in a manner of circumference, to form the anchor of larger-diameter circumference Determine structure.The distal side anchoring structure and nearside anchoring structure deployed on the opposite side of cavity or defect (is determined when with feed status During position) can have essentially identical construction and size, or the anchoring structure may be designed as the length with change, the structure of change Structure make, changed etc..In certain embodiments, it is positioned at the inside and outside anchoring structure of inner chamber defect substantially each other Alignment, and in certain embodiments, the inside and outside anchoring structure for being positioned at inner chamber defect substantially interlocks toward each other Or deviate.

In another embodiment, implantable device combines one or more anchors including enclosed construction substantially as discussed above Determine structure and/or the collar or holding structure.In this embodiment, anchoring structure includes being arranged on enclosed construction or tied with closing At least two locating rings that structure is additionally associated.In the deployed state, locating ring is configured to and is dimensioned so as to contact move The inwall of arteries and veins knurl and/or the vascular wall near aneurysm, and enclosed construction is reclined and the biasing of aneurysmal wall or recline Vascular wall biasing near aneurysm neck, so as to which enclosed construction be held in place, covers aneurysm neck substantially.

In the deployed state, the enclosed construction and (multiple) anchoring structure can be positioned on the inside of aneurysm neck and/or outer Portion.For example, in one embodiment, the implantable device is in aneurysmal internal expansion so that relative anchoring structure contact Aneurysmal inwall and enclosed construction cover aneurysmal import or knurl neck substantially, and the circumference of enclosed construction is aneurysmal Vascular wall internal or that contact is near aneurysm neck.In another embodiment, blood of the implantable device at aneurysm Deploy in pipe so that (multiple) anchoring structure contacts vascular wall, and the circumference of enclosed construction covers aneurysm neck and connect substantially Touch the vascular wall near aneurysm neck.According to the construction of (multiple) anchoring structure, multiple anchor rings can be positioned as after the expansion Contact or the closely vascular wall near aneurysm neck and/or the vascular wall substantially relative with aneurysm neck.

In yet another embodiment, the implantable device includes enclosed construction and anchoring structure, and the enclosed construction, which has, to be connected Generally conical or conical butt the part of close membrane is connected to, the anchoring structure includes at least two positioning elements.Herein In embodiment, the conical section of the enclosed construction preferably includes the discontinuous network structure being made up of shape changing metal material, It expands at least a portion of contact aneurysm inwall during expansion.The base portion of the discontinuous network structure of taper is preferred Ground is connected in close membrane or associated, and the close membrane covers aneurysm neck substantially in the deployed state.Anchoring structure and envelope Structure correlation is closed, and may include multiple locating rings, locating ring contacts the vascular wall near aneurysm neck in the deployed state At least a portion.According to another embodiment, the anchoring structure has at least two petal-like structures, the petal-like structures bag Include metal structure for example associated with permeable or impermeable covering.According to another embodiment, the grappling knot Structure may include the discontinuous network structure of the second taper, and it has the construction more shallow than the construction of enclosed construction.

The enclosed construction placed across aneurysm neck can have the opening or the line of rabbet joint at center, for passing through other conveying mechanisms Or the seal wire of detent mechanism, or for introducing compound, device etc. after closed system is placed.According to some of the present invention Method, after enclosed construction is placed, the additional embolization device of embolism of bung flange, liquid or particle etc. is available to pass through envelope The delivery conduit for closing the opening insertion of structure introduces.In certain embodiments, additional embolization material and/or device can be used for making The circumference of locking device reclines the biasing of aneurysmal inwall, and therefore contributes to enclosed construction being held in place, basic covering Aneurysm neck.

Implantable device disclosed herein, which can utilize, promotes induction system and/or separating mechanism to be delivered to by delivery conduit Target point.Enclosed construction, scaffold and anchoring structure are generally along transport axis radial compression, and with base under feed status This cylindrical construction arrangement.In the embodiment using moving system, the impeller is located near nearside anchoring device, and And locking device can be shifted relative to delivery conduit.By releasing and being maintained by device device on one's own initiative from delivery conduit The combination for extracting delivery conduit on one's own initiative out while stationary state, expansion can be achieved.In an alternative embodiment, implantable dress Put the resolution element for combining and discharging or separating after the expansion.Separating mechanism known in the art, including mechanical system, electrolysis System, hydraulic system and other systems, it is used equally for deploying implantable device disclosed herein.

In a kind of development system, device silk (device wire) be arranged on the present invention implantable device on or with Correlation.The near-end of device silk can be arranged on or near separating mechanism, and the separating mechanism includes deformation actuation mean, and it has The construction of substantial linear and it is fixedly connected to conveying silk, pipeline, conduit etc. in its near-end.The near-end of device silk and actuate member The distal end of part has a coupling mechanism coordinated, the coupling mechanism provided under feed status to the positive connection of implantable device with And implantable device is led to the reliable guiding of desired separation point position.By the way that the deforming force of such as heat or electric current is applied Actuation mean is added to produce deformation in actuation mean, the actuation mean release device silk, it is allowed to extract actuation mean and defeated out Wire feed, actuation mean is separated from device silk after desired locations are placed the device in so as to reach.

Accompanying drawing briefly describes

The various aspects of the invention required by applicant are illustrated schematically in the figures, and accompanying drawing is only used for schematic mesh , and not be drawn to scale.

Figure 1A represents the amplification schematic front perspective of one embodiment of the implantable locking device in deployed condition Figure.

Figure 1B represents that the amplification schematic front of another embodiment of the implantable locking device in deployed condition is saturating View.

Fig. 1 C, 1D, 1E and 1F are schematically illustrated in Figure 1A and Figure 1B of aneurysm site expansion locking device.

Fig. 2A shows the amplification schematic front perspective view of another implantable locking device in deployed condition, Fig. 2 B The implantable locking device for schematically showing Fig. 2A deploys at vascular defect.

Fig. 3 A and 3B show the amplification schematic front perspective view of another implantable locking device, and Fig. 3 A device is in The partially unfolded state, Fig. 3 B device are in its fully unfolded position.

Fig. 4 A-4C schematically show the implantable of Fig. 3 A and Fig. 3 B in the partially unfolded state and its fully unfolded position Locking device.Implantable locking device in Fig. 4 A display insertion aneurysm necks；Fig. 4 B are shown in aneurysm and intravascular are in Fig. 3 B of deployed condition device (being represented by dashed line)；And Fig. 4 C are shown in the dress of Fig. 3 B in deployed condition in aneurysm Put, and aneurysm and blood vessel are shown with section.

Fig. 5 shows the enclosed construction for including flexible patch (patch), and the flexible patch has the week for being arranged on enclosed construction Multiple anchoring structures near boundary.

Fig. 6 A-6C show the amplification perspective schematic view of the implantable device in deployed condition, implantable device tool There is the neck-shaped element with rock-steady structure.

Fig. 7 A show the amplification schematic side elevation of another embodiment of the implantable device in feed status, and this can Implanted device has the enclosed construction that is combined with anchoring structure, and Fig. 7 B, which are shown, is in the of the invention implantable of the partially unfolded state The amplification schematic side elevation of another embodiment of device.

Fig. 8 shows the amplification schematic side perspective view of the implantable device in deployed condition, implantable device tool There is relative grappling pole.

Fig. 9 shows the amplification schematic side perspective view of another embodiment of the implantable device in deployed condition, The implantable device has substantially spherical packaged unit.

Figure 10 shows the amplification schematic side perspective view of another embodiment of the implantable device in deployed condition, The implantable device has bung flange structure.

Figure 11 is shown in the amplification schematic side elevation of the implantable device of the invention in induction system.

Figure 12 A-E show the enlarged diagram for placing the useful method of deploying of device of the invention.

Detailed description of the Invention

On describing and illustrating the implantable system of the present invention in detail as the application of aneurysm locking device.So And, it should be understood that these systems are not limited to this application, and can combine other vasculars, tissue or air duct cavity, Abnormal etc. treatment and repairing is adapted to and applied.Similarly, it should be understood that for the side for the applicant for repairing defect and opening Method is not limited to system described herein.

The implantable locking device of the present invention generally comprises the enclosed construction placed across tissue or vascular defect and will sealed The anchoring structure for closing structure positioning and being held in place.It is disclosed that multiple alternatives and alternative construction.It is disclosed herein (multiple) flexible patch or (multiple) film used in enclosed construction is generally made up of flexible material, and the flexible material can be small Conveyed under diameter feed status by conduit, and larger size configurations are presented in the deployed state.In one embodiment, The enclosed construction is made up of the substantially impermeable material of the liquid of such as blood and body fluid.Alternatively, the enclosed construction can It is made up of following material, the material can be semi-permeable or pass through by the liquid of such as blood and body fluid, and at least allows through benefit The limited exchange of piece or film.The enclosed construction can have a variety of constructions according to device application, and can be for substantially it is circular, ellipse Circular, avette, triangle, polygon etc..

The enclosed construction is made up of (a variety of) material, the material for bio-compatible and Biostatic, and it is compressible, It is foldable or can additionally deform, for minor diameter profile to be presented in the case where loading or being attached to the feed status of delivery conduit. Forming the material of enclosed construction may include for example a variety of natural polymers or synthetic polymeric material；Silicone material；Rubber material Material；Woven or nonwoven textile material, such as Dacron^TM；Fluoropolymer, such asPolytetrafluoro Ethene (PTFE) material or such as GORE- Deng expanded PTFE (ePTFE)；Polymeric material, such as polyurethane, polyurethane/silicon resin composition and copolymer, etc..In another embodiment In, enclosed construction may include metal material, such as thin film shape memory alloy, such as film Nitinol, and such as Nitinol is closed Gold.A variety of film layers and film including Multiple components and component can be provided.In certain embodiments, the enclosed construction by flexibility and The material of elasticity is formed, and is placed on tissue therein with the enclosed construction or the movement of blood vessel or pollex substantially radially expand Exhibition and contraction.

In certain embodiments, the enclosed construction includes network structure, and the network structure has equal in its surface region Even or uneven construction.Generally, the enclosed construction with reticulated structure is with generally fine network structure.In some realities Apply in example, the enclosed construction has the network structure that can radially extend.In other embodiments, the enclosed construction have can edge The network structure of one or more axis extension.

The enclosed construction can have porous or perforation surface texture, hole at least a portion of their surface area It is arranged as providing substantially homogeneous porosity over regions of the surface, or hole is arranged as carrying in the different surfaces region of enclosed construction For different porositys.Average pore size can be basically identical in the surface region of enclosed construction, or can provide with not With the hole of Size Distribution.Generally, it is being suitable from the pore-size in the range of about 0.5 micron to 200 microns.One In individual embodiment, there is provided such pore structure, its allow liquid flow through the enclosed construction but exclude include red blood cell greatly Protein and cell.Generally, hole of the average diameter less than about 10 microns will exclude big protein and cell, while Fluid is allowed to penetrate and cross film.The arrangement of hole can formation rule or irregular pattern, the construction of hole can be consistent Or it is inconsistent, and can be circle substantially, ellipse, square etc..Such as it can be set in the peripheral part office of enclosed construction Bigger porosity is put, the peripheral part is after the placement near to or in contact with tissue or blood vessel wall.

Alternatively or additionally, the enclosed construction can carry out promoting the table of cell attachment and growth on one or both sides Face is handled.For example, in one embodiment, forming the material of enclosed construction has following surface structure, the surface structure is It is irregular or coarse, or the surface irregularity with the cell attachment for promoting material.In another embodiment, should Enclosed construction can have three-dimensional construction, and the three-dimensional is constructed with pit, groove, the passage using regular or irregular pattern Deng to promote cell attachment and again endothelialization.

In some devices disclosed herein, the enclosed construction of implantable device and/or other components, including one or Multiple anchoring structures, it is configured to or handles to promote cell in folded-out position ingrowing or attachment, or including promoting Material or (a variety of) material of the cell in folded-out position ingrowing or attachment.Similarly, method of the invention may include Promotion cell is introduced before placing implantable device, during implantable device is placed and/or after implantable device is placed In the ingrowing of device folded-out position and (a variety of) preparation of endothelialization again.For example, for vascular applications, some applications are wished Promote blood vessel can by place the present invention device and the aneurysm repaired or the endothelium again of the opening position of other vascular defects Change.The many kinds of substance used can be associated in U.S. Patent Publication 2004/0087988 and 2004/ with the method and system of the present invention It is described in 0193206, above-mentioned patent is disclosed by reference to be fully incorporated in the present invention.

Can before device expansion, during device deploys or after-applied multiple material in device expansion, or with can Implanted device is associated, to promote cell ingrowth.Include such as protein available for this purpose biocompatible material, it is all Such as collagen, fibrin, fibronectin, antibody, cell factor, growth factor, enzyme；Glycan, such as heparin, chondroitin；It is raw The cross-linked gel in thing source；Nucleic acid；Poly- (.alpha.- hydroxy acids)；RNA；DNA；Other nucleic acid；Polyester and poe, it is such as poly- Glycolide, polyactide and PLGA；Polylactone including PCL；PPDO；It is such as poly- The polyaminoacid of lysine；Polybutylcyanoacrylate；Poly- (phosphine piperazine)；Poly- (phosphate)；Polyesteramide；Polyacetals；Polyketals；Bag Include the makrolon of trimethylene carbonate and poly- orthocarbonic ester；Degradable polyethylene；Poly- alkylene ethanedioic acid ester；Poly- alkylene amber Acid esters；Chitin；Chitan；Oxycellulose；Polyhydroxy-alkanoates, it includes poly butyric ester, polyhydroxy Valerate and its copolymer；The polymer and copolymer of PEO；The PEO that acrylic acid terminates；Polyamide；It is poly- Ethene；Polyacrylonitrile；Polyphosphazene；The polyanhydride formed by dicarboxylic acid monomer, it includes unsaturated polyanhydride, poly- (amide anhydride), gathered (carboxylic acid amide esters) acid anhydride, the equal polyanhydride of aromatic-aliphatic, aromatic polyanhydride, poly- (ester acid anhydride), fatty acid-based polyanhydride etc.；It is and other raw Thing Compatible Polymeric Materials generate polymeric material, and its copolymer and terpolymer naturally；The fragment of bioactive materials With the mixture of above-mentioned material.

The polymer of some bio-compatibles is considered as bioabsorbable, and suitable and apparatus and method of the present invention Association uses, and the polymer of the bio-compatible includes polyactide, PGA, PLGA, polyanhydride, poly- p- pairs Dioxanone, trimethylene carbonate, PCL, polyhydroxy-alkanoates etc..It also can be used and be not generally regarded as giving birth to The polymer of the bio-compatible of thing degraded, it includes polyacrylate；Ethylene-vinyl acetate；Cellulose and cellulose derive Thing, it includes acetylbutyrylcellulose and cellulose acetate propionate；The cellulose acetate and its derivative that acyl group substitutes；Can not be rotten The polyolefin of erosion；Polystyrene；Polyvinyl chloride；Polyvinyl fluoride；Polyethylene (imidazoles)；Chlorosulfonated polyolefin；PEO；It is poly- Ethylene glycol；PVP；Polyurethane；Polysiloxanes；The copolymer and terpolymer and above-mentioned material of above-mentioned material The mixture of material.Exemplary polymer is it is known in the art that those skilled in the art will be appreciated that, this polymer is too More can not be listed here.Therefore, this list being merely to illustrate property purpose, rather than detailed purpose.

Non-cohesive material can also be used for the closed system of the present invention.Suitable non-cohesive material includes such as hormone and resisted swollen Knurl agent.The example of other biocompatible materials for promoting to be combined with the vascular system of patient for example including the mankind that treat or Animal tissue, including such as cell or cell fragment；Artificial vascular tissue；From bladder, stomach, liver carcass material；It is natural Inhereditary material of source or synthetic source etc..

Other types of synthetic also can be with the enclosed construction or (multiple) anchoring structure of the closed system for forming the present invention It is associated.For example, hydrophilizing agent and/or water-repelling agent or adhesive may be provided in the whole of (multiple) structure or in a part. Similarly, including the anti-friction agent of such as PTFE fluoropolymer may be provided in the whole of (multiple) structure or in a part, In order to deploy from delivery conduit or sheath.It is radiopaque mark or radiopaque mixture can with apparatus structure certain Individual structure or part are associated, in order to which the device of expansion is precisely located, is placed and monitored.For example, in a reality To apply in example, radiopaque synthetic may be incorporated in enclosed construction, or as the coating on enclosed construction.In another reality To apply in example, certain therapeutic agent, antiseptic, coagulant, anticoagulant etc. can be associated with some structure of apparatus structure or part, Or it can deploy before implantable device expansion, during implantable device deploys or in implantable device after-applied.Close Suitable preparation is known in the art, and combines other types of implantable device and use.

Enclosed construction may include multilayer, and can have a variety of coating associated there or other materials, such as adhere to The expandable material of material or adhesion substance, therapeutic substance, hydrophilic material or hydrophobic material, such as hydrogel, is not transmitted Wire tag etc..For example, in one embodiment, the settable enclosed construction in the deployed state of expandable hydrogel and/or On the surface for facing or contacting aneurysmal inside of anchoring structure.In another embodiment, it is easy to form embolism or thrombus Preparation or the settable enclosed construction and/or anchoring structure in the deployed state of formulation compositions face or contact in aneurysmal On the surface in portion, to promote to be internally formed embolism in aneurysm.In yet another embodiment, thrombosis and the system condensed are reduced The settable enclosed construction and/or anchoring structure in the deployed state of agent or formulation compositions faces or contacted blood vessel or vascular wall On surface, said preparation or formulation compositions such as heparin, tissue plasminogen activator (tPA), Abciximab etc..At another In embodiment, the preparation or formulation compositions that prevent the inflammation at ISR and/or reduction position may be provided at enclosed construction and/or anchor Determine on the surface of structure, said preparation or formulation compositions such as Paclitaxel or derivative or the like, Sirolimus is all Such as the compound of the anti-inflammatory of steroids, inhibin, brufen etc..In yet another embodiment, radioactive synthetic can be with The surface of enclosed construction and/or anchoring structure is associated, for therapeutic purposes or imaging purpose.

Substantially continuous surface region can be had by forming the film of enclosed construction, or can have one or more openings or groove Seam, it helps to place implantable device under feed status or the device is arranged on conduit or induction system.The film passes through Shaping, bonding, suture, embedded etc. are fixed on framework or anchoring structure, and the framework or anchoring structure preferably include such as shape The shape-changing material of shape memory alloys.Some membrane materials can also by coating, dip-coating etc. being applied on framework or anchoring structure or Person applies to framework or anchoring structure.

The framing component of supporting enclosed construction can be made up of the shape-changing material of bio-compatible, the framing component such as grappling knot Structure and reinforcement structure, the shape-changing material of the bio-compatible have superpower elasticity and/or shape memory characteristic, such as shape memory Alloy.The shape-changing material changes shape in a predictive manner when applying the deformation power of heat, electric current etc., so that it is presented Predetermined deployed condition.Active force for producing deformation is usually temperature change, and the temperature change is for example by the way that device is drawn Enter body temperature environment, device is applied heat to by using external heat mechanism or is added by making current flow through conducting element The hot device and produce.After shape-memory material to be heated to phase transition temperature of material or more, the framework knot of the device The construction of its predetermined large-size is presented in structure and/or (multiple) anchoring structure.

Nitinol with ultra-strong elasticity and shape memory characteristic is the preferable shape note for apparatus of the present invention Recall alloy.Framework and anchoring structure such as can be formed as solid silk, tubular filament, braided material, and/or can from pipeline configuration or Cut out in cylindrical structural.Framework and anchoring structure can combine other materials, and can have and be arranged between frame structure Coating or film among.In one embodiment, framework and anchoring structure can utilize following sputtering technologies known in the art Formed by the thin film shape memory alloy of such as film nitinol.

Implantable device generally (is referred to as " conveying using with promotion conduit or the delivery conduit of bar or special microtubular Conduit ") or utilize the moving system with separating mechanism to be delivered to target point.For example, in a system, the enclosed construction It is separately mounted with small profile state to the distal end of delivery conduit, and is covered by contractile sheath and remained small outer Shape state.The delivery conduit can be positioned at aneurysm neck or is positioned in aneurysm neck using conventional art, and in sheath After contraction, the enclosed construction is presented its predetermined deployed condition and placed across aneurysm neck.More specifically, in the first step In rapid, after a part for sheath is shunk, the first anchoring structure deploy and is positioned as contacting or approaches inside aneurysm The tissue near aneurysm neck；In the second step, enclosed construction or film are positioned across aneurysm neck and covered substantially Aneurysm neck；After the complete contraction of sheath, the second anchoring structure is deployed and is positioned as contacting or close in aneurysm neck Neighbouring interior vessel.

Figure 1A shows the embodiment of locking device 30, it include being attached on two anchoring structures 32,33 or with two Anchoring structure 32,33 associated sticking patch or enclosed construction 31.Described above is the suitable of the construction for enclosed construction or film Material.Enclosed construction 31 is supported by frame structure 34, and the frame structure 34 is arranged at the perimeter portion of enclosed construction 31 In, and be attached to by bonding, suturing etc. on enclosed construction 31.Frame structure 34 is arranged on wing anchoring structure 32,33 It is or related with wing anchoring structure 32,33.Frame structure 34 and anchoring structure 32,33 all preferably include such as Nitinol conjunction The shape-changing material of golden material.

Anchoring structure 32,33 may include solid silk or tubular structure, or can be by with braiding structure or other netted knots The material of structure is formed.The tectonic sieving of anchoring structure 32,33 under deployed condition exists at least a portion of anchoring structure 32,33 Aneurysmal inwall or the inwall of relevant blood vessel are contacted after expansion.The construction of anchoring structure 32,33 can be substantially circular, ellipse Circle, which is either additionally formed curve construction or anchoring structure 32,33, can form polygonal structure.In a preferred embodiment, As shown in Figure 1A, anchoring structure 32,33 be oval curvilinear structures substantially, and it is bent outwardly to framework from attachment joint 35 Structure 34, then returned inwardly each other in the end away from attachment joint 35.

In the embodiment shown in Figure 1A, anchor ring 32,33 has roughly the same construction and roughly the same size, and And arrange substantially opposite one another.In another embodiment, anchoring structure can have different construction and/or size.For example, In one embodiment, an anchoring structure is longer than another anchoring structure and/or wider, or anchoring structure can have Different three-dimensional curve constructions or polygonal structure.Though it is shown that two anchoring structures 32,33, it is to be understood that Other anchoring structures can be set.Anchoring structure is preferably with substantially symmetric relative to frame structure 34 and/or enclosed construction 31 Mode arrange.

Figure 1B show include have anchoring structure 37,38 enclosed construction 36 similar locking device, anchoring structure 37, 38 are attached in frame structure 39 along the relative lateral margin of frame structure or are protruded from frame structure 39.Alternatively, the closing Structure 36 can have the opening or the line of rabbet joint being arranged in approximate centre region.Anchoring structure 37,38 shown in Figure 1B is slight curved Bent, and extend beyond the corresponding terminal part of frame structure and enclosed construction in its terminal part office.In this embodiment Enclosed construction and frame structure generally there is the surface region of the surface region more than aneurysm neck, and the anchoring structure leads to Often after the device is placed inside aneurysm.In such configuration, the anchoring structure applies laterally on enclosed construction Downward power, so that enclosed construction generally conforms to profile of the vascular wall at aneurysm site, so as to relative to the stream in vascular Aneurysm neck is sealed, and vascular wall is rebuild at aneurysm site.

Fig. 1 C-1F are shown schematically in Figure 1A and Figure 1B of aneurysm site expansion locking device.It is grand in blood vessel B Rise and form aneurysm A.As shown in Figure 1 C and 1D, in one embodiment, when locking device 30 across aneurysm A knurl neck and When deploying in aneurysm A, enclosed construction 31 is positioned as covering aneurysmal opening, and anchoring structure 32 and 33 is maintained at dynamic Inside arteries and veins knurl and along at least a portion surface area contact internal arteries knurl wall of internal arteries knurl wall.In this way, Enclosed construction 31 and frame part 34 are supported by across aneurysm opening and are resisted against aneurysm neck from aneurysm external bias On.In the embodiment shown in Fig. 1 C and Fig. 1 D, enclosed construction 31 and frame part 34 are in the outside of aneurysmal inner space Expansion.In the alternative shown in Fig. 1 E, enclosed construction 31 and frame part 34 be supported by across aneurysm opening and It is biased against inside aneurysm in aneurysm neck.

Fig. 1 F show optional development system and method, wherein, the locking device with least two anchoring structures deploys Aneurysmal opening is covered to cause enclosed construction 31 to be positioned as, anchoring structure 32,33 is positioned at outside aneurysm and contacted Interior vessel near aneurysm.In this embodiment, anchoring structure 32,33 can generally be sized for and be configured to Match with the vascular internal diameter near aneurysm neck so that anchoring structure contacts blood in a substantially continuous manner after the expansion Tube wall, without deforming the vascular wall in aneurysm region or expanding.In all of these embodiments, closing dress is being placed After putting, the enclosed construction covers aneurysm neck effectively to repair vascular defect substantially, and the anchoring structure is substantially not Interference with vascular stream.

Fig. 2A shows another locking device 40 including enclosed construction 41, and the enclosed construction 41 is propped up by frame structure 42 Hold, and be installed in grappling 43,44,45 and 46 or be further associated.The characteristic of enclosed construction 41 and construction substantially with it is upper State identical.Enclosed construction 41 is preferably supported by frame structure 42, and the frame structure 42 is arranged at the periphery of structure 41 It is attached in part and by bonding, suturing etc. in structure 41.Frame structure 42 is attached to two pairs of wing anchoring structures 43,44 With 45, on 46 or it is further associated.Frame structure 42 and anchoring structure 43,44,45 and 46 preferably include such as Nitinol The shape-changing material of alloy material, and may include solid silk or tubular structure, or can be by with braiding structure or other netted The material of structure is formed.

The tectonic sieving of anchoring structure 43,44,45 and 46 in the deployed state is in anchoring structure 43,44,45 and 46 At least a portion of each anchoring structure contacts aneurysmal inwall or the inwall of relevant blood vessel after the expansion.Anchoring structure 43,44,45 and 46 construction in the deployed state can be circle substantially, ellipse or be additionally formed curve construction, or Person can form polygonal structure.In the preferred embodiment shown in Fig. 2A, anchoring structure 43,44,45 and 46 is ellipse substantially The curvilinear structures of shape, it is bent outwardly to frame structure 42 from attachment joint, then away from frame structure 42 end that This inwardly is returned.In the embodiment shown in Fig. 2A, anchor ring 43,44,45 and 46 formed roughly the same construction and Roughly the same size.Anchor ring 43 and 46 is respectively with relative to the positioning of the substantial mirror images direction of anchor ring 44 and 45.Similarly, Anchor ring 43 and 44 is respectively with relative to the positioning of the substantial mirror images direction of anchor ring 46 and 45.In an alternative embodiment, anchor ring The construction and/or size of each anchor ring in 43,44,45 and 46 can change, every in anchor ring 43,44,45 and 46 The construction and/or size of individual anchor ring can differ.Though it is shown that two pairs of substantially relative anchoring structures, it is to be appreciated that It is that other anchoring structures or paired relative anchoring structure can be set.Anchoring structure is preferably with relative to framework knot Structure 42 and/or the substantially symmetric mode of enclosed construction 41 are arranged.

Fig. 2 B show the locking device of Fig. 2A shown types, and it is expanded into so that sticking patch 41 is positioned as covering aneurysmal open Mouthful, two anchoring structures are positioned inside aneurysm so as to contact at least a portion of aneurysm wall, and two anchoring structures It is positioned at outside aneurysm so as to contact the interior vessel near aneurysm.Arteries and veins is repaired using the locking device shown in Fig. 2 The method of pipe, which is generally included in expansion in aneurysm A knurl neck, for example includes the first anchoring structure of anchor ring 43,46, and will Anchor ring 43,46 is located proximate to or contacted the internal arteries knurl wall near aneurysm neck；Deploy to close across aneurysm neck Structure 41, to cover aneurysm neck substantially；And for example include the second grappling of anchor ring 44,45 in aneurysm neck external expansion Structure, and anchor ring 44,45 is located proximate to or contacted the interior vessel near aneurysm neck.

The alternative embodiment of aneurysm locking device is shown at the partially unfolded state in figure 3 a, shows in figure 3b For in its fully unfolded position.In this embodiment, locking device 50 includes conical closure structure 51, the conical closure structure 51 With the generally frustoconical construction being connected in close membrane 52, and with including multiple positioning elements 53,54,55 and 56 Anchoring structure, the close membrane 52 have above-mentioned enclosed construction characteristic.

Conical closure structure 51 preferably includes the loose structure or network structure being made up of shape changing metal material, the deformation Metal material provides the minor diameter structure of small profile under feed status, and the expansion shape of expansion is extended to during expansion At least a portion of state, in a state the shape changing metal material aneurysm inwall.The loose structure or network structure exist There can be generally big or generally small space between structure, the space and structure can be symmetrical or asymmetric, and can be General curved or substantial linear and angled.The suitable type of the network structure of extension is known, and for example Used with various stents.Conical closure structure 51 can be covered by flexible fabric or membrane material or therewith at least in part Correlation, or can be related to other types of fibrous material, the flexible fabric or membrane material for bio-compatible and Biostatic , such as silicone material, PFTE materials, Dacron^TMDeng.

Conical closure structure 51 can be connected in close membrane 52 or associated at minor diameter base portion 57.Enclosed construction 51 can have the circumference for the construction for corresponding roughly to minor diameter base portion 57, or alternatively, the circumference of the enclosed construction 51 can have Have and construct bigger shaping structure or different shaping structure than minor diameter base portion 57.For example, in one embodiment In, enclosed construction 51 be arranged on it is close in the frame structure 58 of its circumference or associated, and in the inner side position of its circumference The place of putting is attached on base portion 57 or associated.

The positioning element 53,54,55 and 56 of locking device 50 can have the cyclic structure similar to above-mentioned anchoring structure.It is standby Selection of land, positioning element 53,54,55 and 56 may include solid metal structure, netted discontinuous structure or flexible wherein Material is arranged in the frame structure for limiting the positioning element or structure associated therewith.Two or more positioning elements Can be to be configured and arrange relative to the approximately radial symmetrical arrangement of enclosed construction 51.In another embodiment, taper Discontinuous network structure can be used as anchoring structure, and with the more shallow construction of the construction than conical closure structure 51.

During Fig. 4 A-4C are shown in expansion and in expanding into aneurysm and across the expansion shape after aneurysm The locking device 50 of state.Locking device 50 in Fig. 4 A display portions insertion aneurysm A.When the first anchoring structure passes through aneurysm Neck and when being positioned in aneurysm, and film 52 extends across aneurysm neck and base closed aneurysm neck, expansion taper envelope Close structure 51.Positioning element 53,54,55 and 56 deploys and is located at the outside of aneurysm neck, and contact after the expansion dynamic At least a portion of vascular wall near arteries and veins knurl neck.Therefore, vascular wall will be repaired by placing this closed system, and vascular is repaiied Multiple extremely normal and healthy construction.

Fig. 5 shows another embodiment of the implantable device 60 including flexible closure structure 61, the flexible closure structure 61 have on the periphery of enclosed construction or are maintained at multiple anchoring members 62 of the adjacent peripheral edges.As illustrated, anchor Determining part 62 has at least two arms 63 spaced apart, and 64, and the inner surface or outer surface of enclosed construction 61 can be arranged on, Or alternatively can be installed through enclosed construction, and relative arm 63,64 extend from the apparent surface of enclosed construction 61.Arm 63,64 can be located on enclosed construction so that the outer peripheral edge 65 of structure 61 is arranged in the connection of opposing arms 63,64 and enclosed construction 61 The outside at place.

Implantable device 60 preferably radially can be folded or compressed, for minimally invasively defeated by pipe guide Send.Under feed status, arm 63,64 can be at the state of substantially linear, so as to minor diameter, substantially cylindrical structure Make and convey the device.After device is delivered into desired target point with the feed status of minor diameter, a series of arm exhibition Its larger deployed condition is split into, and is located close on the inside of the aneurysm wall of aneurysm neck.Another a series of arm with After deploy so that two serial arms are presented its three-dimensional, be spaced apart and substantially relative position, and the arm of second series It is located close in the interior vessel of aneurysm neck.During corresponding anchoring arm is deployed, enclosed construction 61 is across aneurysm Neck positions, and is open with basic covering.After implantable device 60 is placed across aneurysm neck, enclosed construction 61 covers substantially Knurl neck, and arm 63,64 provides anchor point inside aneurysm and in the blood vessel.Outer peripheral edge 65 can additionally cover aneurysm neck And/or the vascular wall near aneurysm neck, the section of diameter of the outer peripheral edge 65 are more than the section of diameter of enclosed construction 61.

Fig. 6 A-6C show optional locking device.Closed system 70 shown in Fig. 6 A includes Central Closed structure 71, and it has There are the neck-shaped structure 72 and multiple anchoring structures 73 and 74 of reinforcement.Alternatively, enclosed construction 71, which can have, is arranged on approximate centre Opening or the line of rabbet joint in region.The neck-shaped structure 72 of reinforcement can be with the one of enclosed construction 7 or being separately constructed, and is arranged on Near the circumference of enclosed construction 71.Neck-shaped structure 72 includes strengthening part 75 and flexible film member.In a word, the neck-shaped structure of reinforcement It can be cylindrical, avette etc. upright thimble structure substantially to be formed, and is intended in the processus aboralis being placed at aneurysm neck Go out into aneurysmal inside and relative vascular seals knurl neck region.The strengthening part 75 can be with shown zigzag pattern Set, or another schema setting of structure support is provided with strengthening part 75 for upright neck-shaped structure.Although strengthen The direction that neck-shaped structure 72 is shown as the plane of enclosed construction 71 along a direction substantially perpendicular protrudes, it is to be understood that according to institute The construction for the body structure that desired application and expectation are blocked for, the neck-shaped structure 72 of reinforcement can be along relative to enclosed construction 71 Planar shaped is at an acute angle or the direction at obtuse angle protrudes.

Closed system 70 also includes skirt section 76, and the skirt section 76 extends from enclosed construction 71 or neck-shaped structure 72, and has The circumference bigger than enclosed construction 71 or neck-shaped structure 72.The skirt section is additionally operable to the border for the opening that sealing expectation is blocked for, and And it is intended to be maintained at the outside of opening contact site, the opening contact site is the blood near aneurysm neck in aneurysmal example Tube wall.In the geometry of opening is irregular application, it is therefore highly desirable that, and can be correspondingly using the device with skirt section Adjust the size in skirt section.Skirt section is more preferably at least big preferably by the deployment diameter increase at least about 10% of locking device About 15%, it is in certain embodiments at least about 20%.In other embodiments, skirt section is preferably by the expansion of locking device Diameter increase at least about 30%.

Anchoring structure 73,74 is preferably made up of common rigid material, and the rigid material is preferably such as Nitinol Shape-memory material.In the embodiment shown in Fig. 6 A, anchoring structure 73 and 74 is on the opposite side of the plane of enclosed construction 71 It is prominent, and connected by the structural support member 77 of centre.Anchoring structure can for entirety and provide as single structure, or Person can provide the anchoring structure positioned discretely and relatively.Anchoring structure 73,74, which is shown as having in fig. 6, carries fillet General triangular construction.In the alternative embodiment of the locking device 78 shown in Fig. 6 B, anchoring structure have it is more circular, The structure of folder shape.Anchoring structure can have sizes and construction, and can have generally wide or usual narrow profile.It is right In some applications, anchoring structure can have reticulated structure or vesicular structure.Though it is shown that three groups of anchoring structures, it is to be appreciated that , less or more anchoring structure can be set, and anchoring structure is generally with relative to central patch radial symmetric Mode is arranged.

Fig. 6 C show the similar closed system 80 including Central Closed structure 81, and the Central Closed structure 81 has substantially The set ring region 82 and loudspeaker cylindrical skirt 83 of cylinder.General curved is demarcated as between set ring region 82 and loudspeaker cylindrical skirt 83 And it is continuous.Reinforcement is provided by relative anchoring arm 84,85, the anchoring arm 84,85 is toward each other staggeredly and with big Cause the mode arrangement of radial symmetric.

Fig. 7 A show another embodiment (Fig. 7 A) of the locking device 120 of the feed status in minor diameter, and Fig. 7 B show Show the optional locking device 130 in larger-diameter, basic deployed condition.Locking device 120 includes first group of anchoring structure 122 and second group of anchoring structure 124, the phase of this first group and second group of anchoring structure 122 and 124 from middle thimble structure 126 Protruded on offside and be substantially transverse to enclosed construction 128.Anchoring structure 122 and 124 preferably includes shape-changing material, and The structure of substantially cylindrical is formed under feed status shown in Fig. 7 A.These anchoring structures (122,124) radial direction during expansion Outwards bend, to form the cyclic structure of basic circumference in the deployed state.

Anchoring structure 122 and 124 is preferably basic hurtless measure, and is configured to greatest extent reduce to anchoring structure The wound of 122 and 124 tissues contacted in the deployed state.In one embodiment, anchoring structure 122 and 124 has big Cause flat structure and cross-sectional configuration.In the embodiment shown in Fig. 7 A, anchoring structure (122,124) has essentially identical structure Make and size, it is prominent on the opposite side of intermediate collar structure, and with substantially staggeredly or the construction of deviation arrange.Deploying Under state, the not lap of tissue of the anchoring structure 122,124 generally on opposite side of the contact closed the defects of.It is this Arrangement is usually hurtless measure, and promote and maintain tissue viability and the region that is contacted by locking device in blood flow. The distal side pad 123 and nearside pad 125 of expansion can be related to anchoring structure 122 and 124 respectively, with promote the positioning of locking device and Deploy and the contact zone of larger diameter is provided in the contact area of tissue.

Although anchoring structure 122 and 124 is shown as total length more than the general triangular of the length of intermediate collar structure Flat silk structure, it is to be understood that alternative construction can be used.Anchoring structure can combine other reinforcement structures or pressure Distribution structure, it can use the form of other structures or surface region.Alternatively or additionally, such as forming closing knot The film of the film of structure can be used for one or more anchoring structures.

One or more radiopaque marks are preferably provided in the remote intermediate collar structure of anchoring structure 122,124 End near, the end corresponds to implantable device under feed status proximally and distally.For example, pad 123 and 125 can Have or including radiopaque mark or associated, so as to during expansion and after the expansion two groups of anchoring structures of mark Terminal.Suitable radiopaque material, tantalum, gold, silver, barium, platinum, tungsten etc. can be used.Discrete radiopaque mark example It is related to anchoring structure such as by gluing, adhesion, crimping, welding, laser welding etc..

Intermediate collar structure 126 includes the reinforcement structure of the substantial cylindrical formed by rib 127, and the rib 127 is formed The reinforcement structure of substantial cylindrical, and provided with the generally finer and close structure of the structure than anchoring structure 122,124.Rib 127 are bonded in membrane structure or associated, and the membrane structure is flexible and basic with thimble structure in this embodiment It is coextensive.The membrane structure can be related to transverse seal structure 128, or is integrally formed with transverse seal structure 128.It is impermeable Radiographic marker is preferably related to thimble structure 126 and/or transverse seal structure 128.

Fig. 7 B show a part for another locking device 130 of the invention under the partially unfolded state.Closing dress Putting 130 includes first group of anchoring structure 132 and second group of anchoring structure 134, and it dashes forward from the opposite side of middle thimble structure 136 Go out and be substantially transverse to enclosed construction 138.Anchoring structure 132 and 134 is preferably made up of shape-changing material, and the shape-changing material exists The structure (as shown in Figure 7 A) of substantially cylindrical is formed under feed status, and change construction during expansion to make grappling to provide Structure 132,134 forms the larger-diameter structure of the cyclic structure of basic circumference under expansion or the partially unfolded state, such as schemes Shown in 7B.Anchoring structure 132,134 substantially as shown in Figure 7 B, or can be repaired according to by implantable device in the deployed state Tissue defects type and structure, the anchoring structure 132,134 can enter under its fully unfolded position towards the center line of device One step is bent.Similarly, intermediate collar structure 136 can have substantially upright cylindrical structure under its fully unfolded position, such as Shown in Fig. 7 B, or intermediate collar structure can be at an angle of together with anchoring structure or circumference is outwards bent, to provide with noninvasive The mode of wound, which contacts, to be organized near defect and the device is securely clamped in the structural structure near defect.According to The size of defect, the type of tissue to be repaired and thickness etc., various bendings and/or curve in the deployed state can be set Device construction.

Preferably, anchoring structure 132 and 134 is essentially hurtless measure, and is configured to farthest reduce to grappling The wound for the tissue that structure 132 and 134 is contacted in the deployed state.In one embodiment, anchoring structure 132 and 134 has There are substantial cylindrical or tubulose structure and cross-sectional configuration.In the partially unfolded construction shown in Fig. 7 B, anchoring structure 132, 134 is prominent on the opposite side of intermediate collar structure 136, and the construction to be aligned substantially is arranged, thus, when at target point After expansion, relative anchoring structure contacts the relative tissue surface near defect in essentially identical position.Grappling knot The distal terminus of structure 132,134 forms generally big surface region, and the surface region is terminated with generally blunt structure, to provide base The anchoring structure of this hurtless measure, the anchoring structure contact tissue definitely to position and keep the enclosed construction across defect, and The tissue that the anchoring structure is contacted is not damaged.

Although anchoring structure 132 and 134 is shown as total length more than the general triangular of the length of intermediate collar structure Silk structure, it is to be understood that optional construction can be used.Anchoring structure can have other reinforcement structures or pressure to distribute Structure, it can use the form of other structures or surface region.Alternatively or additionally, such as forming enclosed construction The film of film can be used for one or more anchoring structures.

One or more radiopaque marks are preferably provided in the remote intermediate collar structure of anchoring structure 132,134 End near, the end corresponds to implantable device under feed status proximally and distally.For example, by making not transmit Wire material is a part of related to anchoring structure, and radiopaque mark can be set.Suitable radiopaque material can be used, such as Tantalum, gold, silver, barium, platinum, tungsten etc..Radiopaque mark such as can by gluing, adhesion, crimping, welding, laser welding and anchor Determine structure correlation.Band 133 and 135 can for example have or including radiopaque mark or associated, therefore during expansion The terminal of two groups of anchoring structures of mark after the expansion.

Intermediate collar structure 136 includes the reinforcement structure formed by rib 137, and the rib 127 forms substantial cylindrical Reinforcement structure, and provided with the generally finer and close structure of the structure than anchoring structure 132,134.Rib 137 is formed substantially The structure of intersection, and can be bonded in membrane structure or associated, the membrane structure is flexible and can be with thimble structure Substantially it is coextensive.The thimble structure can form generally upstanding cylindrical structural, or as described above, set in the deployed state Ring structure and rib can be at an angle of or be bent with outside circumferential configuration.Centre can be installed or be bonded in transverse seal structure 138 On thimble structure 136 and/or the membrane structure associated with thimble structure or formed with intermediate collar structure 136 and/or with set The associated membrane structure of ring structure, and can be substantially continuous or can have a line of rabbet joint being used for by seal wire or other apparatuses Or opening.One or more radiopaque marks are preferably related to thimble structure 136 and/or transverse seal structure 138.

Fig. 8 represents another embodiment of locking device 90, wherein heart district domain provides the locking device 91 expanded wherein Occluding surfaces, and the substrate for attaching reinforcement structure is also provided, the reinforcement structure includes forming petal in the deployed state Multiple grappling poles 92 and 93 of the circular pattern of shape, relative pole 92 and 93 are the construction of base image.Pole 92,93 is logical Intermediate structure 94 is crossed to be connected to each other.Reinforcement structure is formed as the structure of single interconnection, or peace attachable or coordinated with each other Multiple independent structures of dress.

When locking device 90 is deploying after the device in minor diameter feed status to be delivered to the knurl neck of opening, anchor Determine pole 92 to be expanded to the inside of opening first and be positioned as contacting or close to aneurysmal inwall, and intermediate structure 94 is substantially It is positioned at the knurl neck of opening.When further spreading out, grappling pole 93 is deployed and contacts the inside near aneurysm opening Vascular wall, and enclosed construction 91 is mutually pulled from vascular direction by opening.In this embodiment, locking device 91 can be used for closing Plug is with the opening irregularly constructed.

Fig. 9 shows another embodiment of the locking device 100 under the deployed condition in extension.Locking device 100 wraps The conical or spherical structure 101 of general curved is included, the structure 101 can be closed for example by the thin film shape memory of such as Nitinol Gold is formed.Warp architecture 101 terminates at the smaller diameter end of enclosed construction (not shown), and has opening in larger diameter end. In the embodiment shown in fig. 8, warp architecture 101 includes the membranous wall 102 strengthened by multiple ribs 103 or multiple diaphragm plates.Rib 103 generally with the mode arrangement of radial symmetric, and less or more rib can be set.In another embodiment, membranous wall 102 can be strengthened by network structure or other types of frame structure.

Locking device 100 also includes at least one for being positioned across opening and keeping the holding structure of the device 100 104.Holding structure 104 can use the form of the band of bending or winding, or be formed as petal-like or ring-type structure, And multiple holding structures 104 can be set.During the expansion of device 100, chondritic 101 is positioned in open interior expansion Exhibition, and (multiple) holding structure 104 still opening knurl neck outside, and by contacting the wall of structure near opening Device 100 is anchored in opening.

Figure 10 shows another embodiment of the locking device 110 with spiral structure.For example, frame structure may be provided at At the inner boundary and external boundary of helical structure, and film can mount in frame structure or is integrally formed with frame structure. In one embodiment, helical structure has smaller diameter end and larger diameter end.In another embodiment, closing of the invention dress Putting may include relative Double-spiral bung flange construction.In this embodiment, there is provided relative bung flange structure, it is small straight that it is included in its The middle connection of path portion and in opposite direction two bung flanges of radial expansion (using rise/fall pattern).

Bung flange reinforcement structure may include to be embedded in or be attached to the nitinol wires for the membrane material to form enclosed construction or is preferably The biocompatible material of shape-changing material.The size of film to invest the overlapping ring of the film in bung flange reinforcement structure when in winding structure Overlapping border is formed when making.Locking device 110 expand into so that the larger diameter end of the terminal of a bung flange be positioned at it is to be occluded The inside of opening, and when device deploys, the spiral-shaped opening that reclines forms and become tight.Two relative spiral shells of the device The small diameter portion that coil structures meet herein is positioned as the knurl neck across opening, and the relative bung flange is deployed in the area of open outside In domain and contact the wall of structure (such as blood vessel) near opening.

As described above, can be by such as film nitinol for the enclosed construction in closed system disclosed herein and film Thin film shape memory alloy formed.It is preferably for the thickness of film nitinol in the film and enclosed construction of the present invention About 0.5-100 microns, more preferably about 2-50 microns, and can respectively the titanium between 45-55% and nickel form by composition.

For example, using United States Patent (USP) 6, the sputtering technology described in 533,905 prepares film nitinol, so as to which this is special The disclosure of profit is fully incorporated in the present invention by reference.This technology can use the core formed by steel, glass, silicon etc. (mandrel), its outer layer etched with exposure, the thin layer sputtering sedimentation of nitinol is on the outer layer.Sputtering After deposition, the thin layer for forming nitinol on core is heated in an annealed state, and for example pass through by Core and attached thin layer discharge the film of gained exposed to etchant from core.By forming bag on annealing thin film Barrier layer containing opening pattern, the film of covering is exposed to solvent to form the window corresponding to opening pattern, Yi Jiqing Except the barrier layer, window or small opening or hole can be formed in film nitinol.Structural member can close in Nitinol It is positioned at before the sputtering sedimentation of gold on core, so that film is directly attached on structural member.

For example can be from such as film Ti-Ni alloy (i.e. nickel for the framework in locking device or supporting member and anchoring members Titanium promise alloy) thin film shape memory alloy pipe or cylinder in cut out or etch.For etching thin film shape memory alloy Technology to be known in the art.In one embodiment, for example, such as Gupta et al. (SMST-2003： Proc.Intl.Conf.Shape Memory Superelastic Technol., (Pacific Grove, CA) Eds.A.R.Pelton＆T.Duerig, p.639,2003) it is described, light-wall pipe can be prepared.In brief, plural layers Nitinol Continuously sputtering sedimentation is on flat substrate surface for alloy and expendable material (such as chromium), wherein the first sedimentary is by chromium shape Into two layers then deposited of nitinol are separated by the second layer of chromium, what the flat substrate surface such as polished And the silicon chip of oxidation.The thickness of the nitinol layer can be 1 to 40 micron, and the thickness of layers of chrome may be about 500 angstroms.Using Two optical mask plates (photomask) (being referred to as mask 1 and mask 2), mask have the size and dimension of determination resulting structures Predetermined pattern designs, and the structure obtained by this is cylinder or pipe in this case.Mask 1 includes being used to make the second chromium on chip The design of pattern layers, mask 2 include making the design of nitinol pattern layers.Make film nickel using the MEMS technology of standard Titanium promise alloy and layers of chrome patterning.After film nitinol and layers of chrome are deposited on chip, by the way that chip is immersed It is recessed so as to be formed between the first nitinol layer and the second nitinol layer to dissolve all layers of chrome in chromium etchant Locate (pocket), therefore multi-layer film structure is removed from chip.By the way that the tight fit core for example formed by stainless steel is inserted Recess between two nitinol layers and the structure is heat-treated with 500 DEG C in a vacuum, will had substantially long The membrane structure of the release of square configuration is changed into three-dimensional cylinder.Window with all desired sizes, shape and pattern can Formed using the photoetching technique of standard in nitinol layer.

On the other hand, implantable system disclosed herein includes the locking device with device silk, and the device silk is with separating Implantable device is separably connected to convey on silk/promotion silk by joint together.Device silk is generally with implantable device into whole Body, or be attached to by separating joint in its far-end on implantable device, and it is used for leading by using guiding catheter Navigate and implantable device is delivered to internal desired locations.Suitable device silk, separating joint and conveying silk/promotion silk are this Known to field, and available for the locking device of the present invention.Material available for the device silk and conveying silk is this area institute It is known.

The closed system of the present invention is used to repairing aneurysmal vascular defect and forms its in inner chamber, tissue etc. Its physiological defect or cavity.The present invention method and system using minimally-invasive intracavitary technology repairing and rebuild internal chamber wall or Tissue defects, without invasive surgical operation.Conveying and expansion, which have been performed the operation typically directly, works as, and can player than many Art is time-consuming less, thus reduces the risk of complication.

Figure 11 shows this hair being loaded in delivery conduit for navigating to target repairing point and deploying at target repairing point Bright implantable device, Figure 12 A-E show exemplary conveying and method of deploying.Induction system 140 includes delivery conduit 142, It has suitably sized, flexible and pushability, for navigating to desired target repairing point, such as forms in the blood vessel dynamic Arteries and veins knurl or cavity.The conveying of target point of delivery for reaching such as neuro-vascular aneurysms includes navigation and passes through (multiple) small inner chamber And/or the embodiment of tortuous passageway, delivery conduit 142 may include the microtubular with minor diameter and usual high flexibility.Conveying is led (multiple) distal side segmentation of pipe is for example segmented more soft than nearside.A variety of delivery conduits are known in the art, and are adapted to In the induction system for the present invention.

Repair apparatus 144 can be any repair apparatus described here with two groups of relative anchoring structures and/or Locking device, and be preferably preloaded in minor diameter feed status in the distal end 141 of delivery conduit 142.Work as repair apparatus 144 in order to convey when being positioned in delivery conduit 142, and the distal end 145 of repair apparatus 144 preferably corresponds to anchoring structure, The anchoring structure be intended to be placed at the inwall of aneurysm to be repaired or cavity, or be placed on relative to transfer passage with it is interior At the relative internal chamber wall of wall or cavity surface.One or more radiopaque marks 146 may be provided at the remote of repair apparatus 144 At or near end 145.When repair apparatus 144 is positioned in delivery conduit 142 to convey, the near-end of repair apparatus 144 147 preferably correspond to anchoring structure, and the anchoring structure is intended to be placed near the knurl neck of aneurysm to be repaired or cavity Vascular wall at, or be placed at inner lumen wall or cavity surface relative to transfer passage.One or more does not transmit The mark 148 of line may be provided at or near the near-end 147 of repair apparatus 144.Additionally or alternatively, repair apparatus 144 can With the radiopaque mark near the central part of device, the central part corresponds roughly to the enclosed construction 149 of device.It is additional Ground or alternatively, radiopaque mark may be configured as related to delivery conduit 142, and mark position corresponds respectively to repair apparatus 144 distal portion and proximal portion.

Induction system shown in Figure 11 and Figure 12 A-E uses the guiding for repair apparatus 144 and the He of seal wire 150 of positioning Impeller 152, the impeller 152 there is guidewire lumen and be positioned as proximal portion 147 for contacting repair apparatus 144 and Repair apparatus 144 is moved relative to delivery conduit 142.Suitable seal wire and impeller are known in the art, and available for defeated Send the repair apparatus and locking device of the present invention.

Therefore, for repairing physiological defect or closing opening or the method for cavity 160 using without intrusion or minimum Repair apparatus 144 in minor diameter feed status is navigated to target repairing point by the technology of intrusion on seal wire 150, and will be right Should in the repair apparatus 144 of the first anchoring structure 145 it is remotely located opening to be repaired or positioning in the openings, such as Shown in Figure 12 A.Alternatively, can be by being positioned and intermediate collar or envelope across the opening of the aneurysm in blood vessel 170 or defect 160 The associated radiopaque mark of structure 149 is closed, positions repair apparatus 144.Then, by by the distal end of repair apparatus 144 from Release in delivery conduit 142 and/or extract delivery conduit 142 so that first group of anchoring structure to be located proximate to or contact in knurl out Internal arteries knurl wall near neck, expansion generally include a series of the first anchoring structure of anchoring arm 145, as shown in Figure 12 B. After expansion, first group of anchoring arm 145 circumferentially extends and opened, and wherein anchoring structure is positioned as contacting or led to close to from conveying Road observation with it is to be repaired the defects of it is relative the defects of surface, or the defects of be positioned to be repaired from transfer passage On opposite side.During expansion and positioning, the radiopaque mark 146 being arranged on the first anchoring structure can be monitored, to ensure Correct and hurtless measure positioning.

After the expansion of the first anchoring structure, including the center section of the repair apparatus of enclosed construction 149 expands into substantially Across opening to be repaired and inaccessible defect opening, as indicated in fig. 12 c.After enclosed construction 149 among expansion, closing knot Structure is opened or extended to cover the opening substantially.In this state, first group of anchoring arm 145 contacts or closely in opening The side of neighbouring aneurysm inwall, and the enclosed construction 149 covering cavities open.Then, by by the near of repair apparatus Side part is released from delivery conduit 142 or extracts the conduit associated with locking device out, including the second anchoring structure 147 Deploy with the portions of proximal of the repair apparatus of associated radiopaque mark 148, as indicated in fig. 12d.Deploying the second grappling After structure, the anchoring arm 147 of the second anchoring structure is positioned as contacting or approached and limit or formed to external expansion and opening The defects of part of transfer passage surface.Now, locking device 144 deploys securely, and seal wire 150 is retracted into delivery conduit In 142.Induction system 140 is retracted from the position, and the locking device effectively repairs the opening, as shown in figure 12e.

Therefore, by the way that enclosed construction is installed as into basic covering opening, and enclosed construction is supported and protected across opening Hold in position, and anchoring structure is positioned on two apparent surfaces of the inner chamber near defect or tissue, side of the invention Method and system effectively repair tissue defect or opening.The subsequent regrowth of cell in the device placement region and tissue Endothelialization effectively recovery organization function and will effectively repair defect again.Radiopaque mark is preferably used for deploying and positioned The device, and available for the position of various time supervision devices after the placement.

Although some preferred embodiments on the present invention describe the present invention in the above specification, what is proposed is permitted More details merely for example purpose, it will be apparent for a person skilled in the art that the present invention allow various changes and improve with And other embodiments, and essence spirit and model of some details described here without departing from the present invention can be significantly changed Enclose.

All patent documents cited in this specification and openly it is fully incorporated in by reference in the present invention.

Claims (10)

1. a kind of implantable device for being used to repair opening or cavity in target tissue defect, the implantable device can be from defeated Status adjustment is sent to deployed condition, the construction of the generally small diameter of the implantable device presentation under the feed status, The construction of larger diameter is presented in the implantable device under the deployed condition, and the implantable device includes：

Enclosed construction, be sized to cover substantially when the implantable device is in the deployed condition opening or Cavity, wherein there is the enclosed construction at least one opening to be passed through in order to another device by and wherein institute Stating enclosed construction includes reinforcement structure, and the reinforcement structure includes framework or the collar；With

When the implantable device is in the feed status in the first direction from the first grappling of enclosed construction extension Structure and the second anchoring structure extended along substantially opposite second direction, first anchoring structure and the second anchoring structure It is prominent on the opposite side of intermediate collar structure with essentially identical construction and size, and with interlock substantially or deviation Construction arrangement, first and second anchoring structure forms the structure of substantially circumference, and the structure of the substantially circumference is described Diameter with more than enclosed construction when implantable device is in the deployed condition.

2. implantable device according to claim 1, it is characterised in that described in the enclosed construction at least one opens Mouth is sized to allow at least one of which of wire or conduit to be passed into the cavity.

3. implantable device according to claim 1, it is characterised in that the enclosed construction includes being surrounded by neighboring area Central area, and the opening in wherein described enclosed construction is in the central area.

4. implantable device according to claim 1, it is characterised in that the opening in the enclosed construction includes groove Seam.

5. implantable device according to claim 1, it is characterised in that also include and first anchoring structure and second The associated at least one radiopaque mark of at least one of which of anchoring structure.

6. implantable device according to claim 1, it is characterised in that the enclosed construction has substantially continuous occlusion Surface region.

7. implantable device according to claim 1, it is characterised in that the enclosed construction, which has, to be configured to described in simulation The structure of destination organization and the radial compliance of motion.

8. implantable device according to claim 1, it is characterised in that the enclosed construction includes being made up of following material Group selected in material：Fluorine-containing synthetic, high polymer material, metal material, thin film shape memory alloy and combinations thereof.

9. implantable device according to claim 8, it is characterised in that high polymer material includes silicone material, rubber Material, Woven fabric and supatex fabric.

10. implantable device according to claim 1, it is characterised in that the enclosed construction at least in part include by Material selected in the group of following material composition：Region porous surface is liquid permeable but be essentially prevented from cell and pass through The material of the enclosed construction.