TW201630574A - Reconstrainable stent delivery system with a slider and knob for actuation and method - Google Patents

Abstract

Devices, systems and methods are described and involve deploying and reconstraining a stent. An intravascular device with first and second elongated tubular members capable of axial motion relative to a housing having an annular lock configured to secure in one operational state and release the intraluminal device in another operational state, the intraluminal device being coaxially disposed over the second elongated tubular member proximal of a distal stop. Actuators on the housing may withdraw or advance the first and second tubular members. The first tubular member is withdrawn to deploy the stent and is advanced to reconstrain the stent. The second tubular member is withdrawn to engage the distal stop with the annular lock prior to reconstraining. The device may have a directional control that is engaged by an actuator to allow only proximal motion of the first elongated tubular member relative to the housing and allows only distal motion of the first elongated tubular member when disengaged.

Description

具有用於致動的滑動件和旋鈕的可再約束支架輸送系統及方法 Re-constrained stent delivery system and method having a slider and knob for actuation 相關申請的交叉引用 Cross-reference to related applications

依照35USC§119或者巴黎公約，本申請要求2015年1月31日提交的美國臨時專利申請(律師案號FSS5013USPSP)和2015年7月27日提交的美國臨時專利申請No.(律師案號FSS5014USPSP)的優先權，這些臨時專利申請的全部內容以參考的方式併入本文中。 In accordance with 35 USC § 119 or the Paris Convention, this application claims US Provisional Patent Application (Attorney Docket No. FSS5013USPSP) filed on January 31, 2015 and U.S. Provisional Patent Application No. (Attorney Docket FSS5014USPSP) filed on July 27, 2015 The priority of these Provisional Patent Applications is hereby incorporated by reference.

發明領域 Field of invention

本公開涉及醫療裝置的領域，並且更具體地涉及用於可控制地佈置支架和再約束局部佈置的支架的醫療裝置或輸送系統及方法。在一些應用中，本公開涉及用於輸送在身體通道或管內使用的自擴張式管腔內移植物(“支架”)的系統，其尤其對於修復由於疾病而變窄或閉塞的血管是有用的。 The present disclosure relates to the field of medical devices, and more particularly to medical devices or delivery systems and methods for controllably arranging stents and re-constraining locally disposed stents. In some applications, the present disclosure relates to a system for delivering a self-expanding intraluminal graft ("stent") for use within a body passage or tube, particularly useful for repairing blood vessels that are narrowed or occluded due to disease. of.

發明背景 Background of the invention

在醫學領域，腔內假體已被廣泛地用於植入血管、膽管、或者生物體的其它類似的腔管。這些假體通常 被稱作支架，並且用於保持、打開或擴張管狀結構。由Palmaz於1985年11月7日提交的美國專利4,733,665中給出了常用支架的一個例子，該專利的全部內容以參考的方式併入本文中。這種支架常常稱為球囊擴張式支架。通常，該支架是由不銹鋼的實心管製成。之後，在支架的壁中製作出一系列的切割。支架具有第一較小直徑，其允許通過將支架壓握到球囊導管上而經過人體脈管系統輸送支架。在球囊導管從管狀構件內部施加徑向向外延伸的力時，支架還具有第二、擴張的直徑。 In the medical field, endoluminal prostheses have been widely used to implant blood vessels, bile ducts, or other similar lumens of living organisms. These prostheses usually It is called a stent and is used to hold, open or expand the tubular structure. An example of a conventional stent is given in U.S. Patent 4,733,665, the entire disclosure of which is incorporated herein by reference. Such stents are often referred to as balloon-expandable stents. Typically, the bracket is made of a solid tube of stainless steel. Thereafter, a series of cuts are made in the wall of the stent. The stent has a first smaller diameter that allows the stent to be transported through the human vasculature by crimping the stent onto the balloon catheter. The stent also has a second, expanded diameter when the balloon catheter exerts a radially outwardly extending force from inside the tubular member.

然而，對於在一些脈管(如頸動脈或股淺動脈)中的使用，這種支架常常是不現實的。頸動脈可容易地從人體的外部進入，並且常常可通過在一個人的頸部觀察而看見。在他或她的頸動脈中放置由不銹鋼等製成的球囊擴張支架的患者可能由於日復一日的活動而容易受到嚴重損傷。作用於患者頸部的足夠大的力(例如由於下降)可導致支架塌陷從而導致對患者的損傷。為了防止這種情況發生並且為了克服球囊擴張支架的其它缺點，開發了自擴張式支架。自擴張式支架像彈簧一樣動作，並且在被擠壓後將恢復到它們的擴張或植入構造。 However, for use in some vessels, such as the carotid or superficial femoral artery, such stents are often unrealistic. The carotid artery can easily enter from the outside of the body and can often be seen by looking at the neck of a person. A patient who has a balloon-expanded stent made of stainless steel or the like in his or her carotid artery may be susceptible to severe damage due to day-to-day activities. A sufficiently large force acting on the patient's neck (eg, due to a drop) can cause the stent to collapse resulting in damage to the patient. To prevent this from happening and to overcome other shortcomings of balloon-expandable stents, self-expanding stents have been developed. Self-expanding stents act like springs and will return to their expanded or implanted configuration after being squeezed.

美國專利4,665,771中公開了一種類型的自擴張式支架，該支架具有徑向和軸向易彎曲的彈性管狀主體，具有預定直徑，該直徑在主體的端部相對於彼此做軸向運動時是可變的，並且該支架是由多個分別為剛性但易彎曲的彈性線絲元件所組成，這些線絲元件限定徑向自擴張的 螺旋結構。在本技術領域，此類型的支架被稱為”編織型支架”並且在本文中如此地稱謂。 One type of self-expanding stent is disclosed in U.S. Patent No. 4,665,771, which has a radially and axially flexible, resilient tubular body having a predetermined diameter that is operative when the ends of the body are axially moved relative to each other. Variable, and the bracket is composed of a plurality of elastic but flexible elastic wire elements, each of which defines a radially self-expanding Spiral structure. This type of stent is referred to in the art as a "braided stent" and is so referred to herein.

其它類型的自擴張式支架使用合金，如鎳鈦諾(鎳鈦合金)，該合金在被設計用於***患者身體的醫療裝置中具有形狀記憶和/或超彈性特性。形狀記憶特性使這些裝置能夠發生變形從而便於將它們***體腔或腔中，然後在身體內被加熱使得該裝置恢復到其”記憶的”形狀。另一方面，超彈性特性通常使金屬能夠變形並且被約束於變形狀態從而便於將容納該金屬的醫療裝置***患者身體，這種變形導致相變。一旦在體腔內，則可以除去對超彈性構件的約束，由此減小其內的應力以便超彈性構件可以通過轉變到原來的相而恢復到其原來的未變形形狀或者接近它(因為植入的形狀被設計成具有一些變形，以便提供力來支撐打開其所被植入的血管)。 Other types of self-expanding stents use alloys, such as Nitinol (Nitinol), which have shape memory and/or superelastic properties in medical devices designed to be inserted into a patient's body. The shape memory properties enable these devices to be deformed to facilitate insertion into a body cavity or cavity and then heated within the body to restore the device to its "memorized" shape. On the other hand, the superelastic properties generally enable the metal to deform and be constrained to a deformed state to facilitate insertion of the medical device containing the metal into the patient's body, which deformation results in a phase change. Once in the body cavity, the constraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can be restored to its original undeformed shape or close to it by transitioning to the original phase (because of implantation The shape is designed to have some deformation to provide a force to support opening the blood vessel into which it is implanted.

具有形狀記憶/超彈性特性的合金通常具有至少兩個相。這些相是馬氏體相和奧氏體相，馬氏體相具有相對較低的抗拉強度且在相對較低溫度下是穩定的，奧氏體相具有相對較高的抗拉強度且在高於馬氏體相的溫度下是穩定的。 Alloys having shape memory/superelastic properties typically have at least two phases. These phases are the martensite phase and the austenite phase, the martensite phase has a relatively low tensile strength and is stable at relatively low temperatures, the austenite phase has a relatively high tensile strength and It is stable above the temperature of the martensite phase.

當把應力施加到顯示超彈性特性的金屬(如鎳鈦諾)的樣品時，該樣品處於一溫度，奧氏體在高於該溫度時是穩定的(即，馬氏體相向奧氏體相的轉變完成的溫度)，該樣品發生彈性變形直到它達到特定的應力水準，在該應力水準，合金然後經歷從奧氏體相向馬氏體相的應力誘導相 變。當相變進行時，合金經歷顯著的應變增加，但具有很少或沒有相應的應力增加。應變增加而應力保持基本恒定，直到奧氏體相向馬氏體相的轉變完成。之後，應力的進一步增加對於導致進一步變形是必需的。馬氏體金屬首先在施加附加的應力時發生彈性變形然後發生具有永久殘餘變形的塑性變形。 When a stress is applied to a sample of a metal exhibiting superelastic properties (such as Nitinol), the sample is at a temperature above which austenite is stable (ie, martensite to austenite phase) The temperature at which the transformation is completed), the sample is elastically deformed until it reaches a specific stress level at which the alloy then undergoes a stress-induced phase from the austenite phase to the martensite phase. change. As the phase change progresses, the alloy undergoes a significant strain increase with little or no corresponding stress increase. The strain increases and the stress remains substantially constant until the transformation of the austenite phase to the martensite phase is completed. Thereafter, a further increase in stress is necessary to cause further deformation. The martensitic metal first undergoes elastic deformation upon application of an additional stress and then undergoes plastic deformation with permanent residual deformation.

如果在任何永久變形發生之前將作用於樣品的負荷除去，那麼馬氏體樣品將彈性地恢復並且轉變回到奧氏體相。應力的減小首先導致應變的減小。當應力的減小達到馬氏體相轉變回到奧氏體相的水準時，樣品中的應力水準將保持基本恒定(但顯著地小於奧氏體轉變到馬氏體的恒定應力水準)直到向奧氏體相的轉變完成，即存在顯著的應變恢復但只有可忽略的相應的應力減小。在轉變回到奧氏體完成之後，進一步的應力減小導致彈性應變減小。在施加負荷時在相對恒定的應力下引起顯著的應變並且在除去負荷時從變形中恢復的這種能力通常被稱為超彈性或偽彈性。正是由於材料的這種性質使得它可用於製造管切割自擴張式支架。現有技術中提到將具有超彈性特性的金屬合金用於意圖被***患者身體內或者以其他方式在患者身體內使用的醫療裝置。參見例如美國專利No.4,665,905(Jervis)和美國專利No.4,925,445(Sakamoto等人)。 If the load acting on the sample is removed before any permanent deformation occurs, the martensite sample will elastically recover and transition back to the austenite phase. The reduction in stress first leads to a reduction in strain. When the stress decreases to the level at which the martensite phase transitions back to the austenite phase, the stress level in the sample will remain substantially constant (but significantly less than the austenite transformation to the constant stress level of martensite) until The transformation of the austenite phase is complete, ie there is a significant strain recovery but only a negligible corresponding reduction in stress. After the transformation back to austenite is completed, further stress reduction results in a decrease in elastic strain. The ability to cause significant strain under relatively constant stress when applying a load and to recover from deformation upon removal of the load is commonly referred to as superelastic or pseudoelastic. It is because of this nature of the material that it can be used to make tube-cut self-expanding stents. It is mentioned in the prior art that metal alloys having superelastic properties are used in medical devices intended to be inserted into or otherwise used in the body of a patient. See, for example, U.S. Patent No. 4,665,905 (Jervis) and U.S. Patent No. 4,925,445 (Sakamoto et al.).

目前用於自擴張式支架的常規輸送系統是所謂的”固定和拉拽(pin and pull)”系統。以下是”固定和拉拽”系 統的一個示例。該輸送系統包括外護套，該外護套是具有遠端和近端及經過其中的腔管的細長管狀構件。典型的外護套是由外聚合物層、內聚合物層以及在內層與外層之間的編織加強層所製成。加強層比內層和外層更加剛性。在”固定和拉拽”系統中，正是該外護套被”拉拽”。”固定和拉拽”系統還包括被同軸地定位在外護套內的內軸。該軸具有在護套的遠端向遠側延伸的遠端以及在護套的近端向近側延伸的近端。在”固定和拉拽”系統中，正是該軸被”固定”。 Conventional delivery systems currently used for self-expanding stents are the so-called "pin and pull" systems. The following is the "fixed and pulled" system An example of a system. The delivery system includes an outer sheath that is an elongated tubular member having a distal end and a proximal end and a lumen therethrough. A typical outer sheath is made from an outer polymeric layer, an inner polymeric layer, and a woven reinforcing layer between the inner and outer layers. The reinforcing layer is more rigid than the inner and outer layers. In the "fixed and pulled" system, it is the outer sheath that is "pull". The "fix and pull" system also includes an inner shaft that is coaxially positioned within the outer jacket. The shaft has a distal end that extends distally at the distal end of the sheath and a proximal end that extends proximally at a proximal end of the sheath. In the "fixed and pulled" system, it is the axis that is "fixed".

“固定和拉拽”系統還具有用於限制自擴張式支架相對於軸的向近側運動的結構，例如被固定地附接到內軸從而充當不動的近側限位器的環，在佈置期間在向近側收回護套時壓握的支架可在近側方向上被裝載抵靠該環。該”支架限位”結構位於護套遠端的近側。位於內軸的端部處的錐形遠側頂端的尺寸可被設置成與外護套的內直徑接觸，並且該遠側頂端也可稱為鼻錐或擴張器。 The "fixing and pulling" system also has a structure for limiting proximal movement of the self-expanding stent relative to the shaft, such as a ring that is fixedly attached to the inner shaft to act as a stationary proximal stop, in the arrangement The stent that is crimped during the proximal withdrawal of the sheath can be loaded against the loop in the proximal direction. The "bracket limit" configuration is located proximal to the distal end of the sheath. The tapered distal tip at the end of the inner shaft can be sized to contact the inner diameter of the outer sheath, and the distal tip can also be referred to as a nose cone or dilator.

最後，”固定和拉拽”系統包括位於護套內的自擴張式支架。該支架在便於輸送的其減小直徑狀態下與外護套的內直徑發生摩擦接觸，更具體地與外護套的內層的內直徑發生摩擦接觸。支架位於限位結構與護套的遠端之間，軸的一部分被同軸地設置在支架的腔管內。在佈置期間當護套被取出並且使支架與該護套一起運動時(由於支架與護套的內直徑之間的摩擦接觸)，支架與限位結構接觸。當支架的近端與限位結構接觸時支架近端的向近側運動被阻止，並且限位結構提供作用於支架的反作用力，該 反作用力與護套作用於支架上的摩擦力是相等且相反的。 Finally, the "fix and pull" system includes a self-expanding stent located within the sheath. The stent is in frictional contact with the inner diameter of the outer sheath in its reduced diameter state for ease of delivery, and more particularly in frictional contact with the inner diameter of the inner layer of the outer sheath. The stent is positioned between the stop structure and the distal end of the sheath, a portion of the shaft being coaxially disposed within the lumen of the stent. The stent is in contact with the stop structure when the sheath is removed and the stent is moved with the sheath during deployment (due to frictional contact between the stent and the inner diameter of the sheath). The proximal movement of the proximal end of the stent is prevented when the proximal end of the stent is in contact with the constraining structure, and the limiting structure provides a reaction force acting on the stent, The reaction force and the friction of the sheath on the bracket are equal and opposite.

為了從”固定和拉拽”系統佈置支架，將系統引導至治療位置。然後，操作者(醫學專業人員)用一隻手將在外護套的近端向近側延伸的內軸固定到患者上。這個動作固定了內軸沿植入支架的患者腔管的縱向軸線的位置。這個動作是”固定和拉拽”系統中的”固定”步驟。醫生用他或她的另一隻手向近側拉拽外護套(將外護套的一部分從患者中朝向”固定”的手拉出)從而不約束、暴露和佈置支架。這個動作是”固定和拉拽”系統中的”拉拽”步驟。 To position the stent from the "fix and pull" system, the system is directed to the treatment site. The operator (medical professional) then secures the inner shaft extending proximally at the proximal end of the outer sheath to the patient with one hand. This action fixes the position of the inner shaft along the longitudinal axis of the patient lumen of the implanted stent. This action is the "fixed" step in the "fixed and pulled" system. The physician uses his or her other hand to pull the outer sheath proximally (the portion of the outer sheath is "fixed" from the patient) so as not to constrain, expose, and deploy the stent. This action is the "pull" step in the "fix and pull" system.

另一種”固定和拉拽”系統的早期示例是如1986年4月8日提交的美國專利4,580,568中所描述的Gianturco支架輸送系統。在這個現有技術的輸送系統中，外護套是單一材料的管，該管不具有在其內的加強結構。具有幾乎等於護套內直徑的直徑的圓柱形平端推送器被***護套中位於支架後面。然後，利用推送器或內軸將支架從護套的近端推送到護套的遠端。通過將內軸相對於患者身體加以固定並拉回到護套上以暴露支架而完成支架的佈置，當除去徑向約束力時該支架擴張，如美國專利4,580,568的圖4和圖5中所示，該專利的內容以參考的方式併入本文中。 An early example of another "fixing and pulling" system is the Gianturco stent delivery system as described in U.S. Patent 4,580,568, filed on April 8, 1986. In this prior art delivery system, the outer sheath is a single material tube that does not have a reinforcing structure therein. A cylindrical flat end pusher having a diameter almost equal to the inner diameter of the sheath is inserted into the sheath behind the stent. The stent is then pushed from the proximal end of the sheath to the distal end of the sheath using a pusher or inner shaft. The arrangement of the stent is accomplished by securing the inner shaft relative to the patient's body and pulling it back onto the sheath to expose the stent, which stent expands when radial restraint is removed, as shown in Figures 4 and 5 of U.S. Patent 4,580,568. The content of this patent is incorporated herein by reference.

另一種市場上的早期自擴張式支架是Wallstent。該支架是編織的，並且在其被佈置時改變長度(縮短)和直徑(增加)，並且其長度的改變是明顯的。授予Wallsten的美國專利4,655,771(在下文中稱為”Wallsten”)描述了幾種用於編織型支架的輸送系統，該專利中被稱為”管 狀主體”。Wallsten的圖11中示出了這些輸送系統中的一個，其被如下描述”在圖11中示出了用於使管狀主體擴張的組件的另一個實施例。該組件構成易彎曲的器械，該器械用於把處於收縮狀態的管狀主體導入例如血管中然後當定位在其內時使該管狀主體擴張。器械的各部分是由易彎曲的外管61和同軸的、也是易彎曲的內管62組成。在外管的一端，佈置有操作構件63。另一個操作構件64附接到內管62的自由端。這樣，內管62可相對於外管61軸向地位移。在內管62的另一端附接有活塞65，該活塞65當運動時沿外管61的內壁行進。當器械將要被使用時，首先將處於收縮狀態的管狀可擴張主體69放置在管61內，帶有活塞65的內管62位於外管61的後部66中。在圖11中，活塞65的起始位置是用虛線表示在67處。這樣，在起始位置，管61的一部分被收縮的管狀主體69填充。在植入期間，將裝置的易彎曲管狀部***血管的用於植入的位置。然後，使構件64在箭頭68的方向上運動，將收縮的主體69經過管61的端部70推出，使管狀主體69的離開管端部70的那部分擴張直到在其擴張位置71其與脈管壁72的內部接合。為簡單起見，在圖11中將管狀主體69和71圖示為兩條彎曲形狀的線。就擴張的主體21與脈管壁72接合而言，通過使構件63在箭頭73的方向上運動而使管端部70運動。通過活塞65推靠主體60的一端，而使收縮的主體69運動。因此，通過構件64和63的同時的相反方向的運動而進行植入，構件64的位移大於構件63的位移”。如同用於Gianturco支架的輸送系統，其護 套未被加強，而是單一材料的管，並且其內軸不延伸穿過支架，而是終止於被約束在外護套遠端處的支架的近端。內軸與外護套是同軸的，並且具有大於減小直徑的”受約束”或壓握支架的內直徑的外直徑。 Another early self-expanding stent on the market is Wallstent. The stent is woven and changes length (shortening) and diameter (increased) as it is placed, and the change in length is significant. U.S. Patent 4,655,771, issued to Wallsten (hereinafter referred to as "Wallsten") describes several delivery systems for woven stents, which are referred to as "tubes". One of these delivery systems is shown in Figure 11 of Wallsten, which is described below. Another embodiment of an assembly for expanding a tubular body is shown in FIG. The assembly constitutes a flexible instrument for introducing a tubular body in a contracted state into, for example, a blood vessel and then expanding the tubular body when positioned therein. The various parts of the instrument consist of a flexible outer tube 61 and a coaxial, also flexible, inner tube 62. At one end of the outer tube, an operating member 63 is disposed. Another operating member 64 is attached to the free end of the inner tube 62. Thus, the inner tube 62 is axially displaceable relative to the outer tube 61. At the other end of the inner tube 62 is attached a piston 65 which travels along the inner wall of the outer tube 61 when moving. When the instrument is to be used, the tubular expandable body 69 in the contracted state is first placed within the tube 61 and the inner tube 62 with the piston 65 is located in the rear portion 66 of the outer tube 61. In Fig. 11, the starting position of the piston 65 is indicated by a broken line at 67. Thus, in the initial position, a portion of the tube 61 is filled with the contracted tubular body 69. During implantation, the flexible tubular portion of the device is inserted into the vessel for implantation. The member 64 is then moved in the direction of arrow 68, and the collapsed body 69 is pushed out through the end 70 of the tube 61, causing the portion of the tubular body 69 that exits the tube end 70 to expand until it is in its expanded position 71. The interior of the tube wall 72 is joined. For the sake of simplicity, the tubular bodies 69 and 71 are illustrated in Figure 11 as two curved shaped lines. With respect to the engagement of the expanded body 21 with the vessel wall 72, the tube end 70 is moved by moving the member 63 in the direction of the arrow 73. The contracted body 69 is moved by the piston 65 being pushed against one end of the body 60. Thus, the implantation is performed by simultaneous movement of the members 64 and 63 in opposite directions, the displacement of the member 64 being greater than the displacement of the member 63. As with the delivery system for the Gianturco stent, it is protected. The sleeve is not reinforced, but a tube of a single material, and its inner shaft does not extend through the stent, but terminates at the proximal end of the stent that is constrained at the distal end of the outer sheath. The inner shaft is coaxial with the outer jacket and has an outer diameter that is larger than the diameter of the "constrained" or inner diameter of the crimping bracket.

當自擴張式支架從其受約束以便輸送的構造轉變到在患者脈管的腔管內的其佈置的擴張狀態時，總長度會由於被稱為縮短(foreshortening)的效應而減小。所發生的縮短的量取決於支架的設計以及在佈置期間所經歷的徑向擴張的量。患者脈管的精確幾何形狀可能不是已知的並且可能經受變化和不規則性，包括不同程度的脈管鈣化。縮短百分比通常被定義為輸送導管裝載狀態(壓握)與標稱佈置直徑(即，當佈置時支架意圖具有的標記直徑，即，”10mm支架”具有10mm的標稱佈置直徑)之間的支架長度的變化除以輸送導管裝載狀態(壓握)時的支架長度，再乘以100。一些自擴張式支架被設計成將支架縮短限制到不明顯的量(例如，小於10%)。然而，由於設計、佈置環境和其它因素，自擴張式支架可縮短達明顯的量(例如，多於10%)。 When the self-expanding stent transitions from its configured configuration for delivery to its deployed expanded state within the lumen of the patient's vessel, the overall length is reduced by an effect known as foreshortening. The amount of shortening that occurs depends on the design of the stent and the amount of radial expansion experienced during deployment. The precise geometry of the patient's vasculature may not be known and may be subject to changes and irregularities, including varying degrees of vascular calcification. The shortening percentage is generally defined as the stent between the delivery catheter loading state (pressure grip) and the nominal placement diameter (ie, the marker diameter that the stent is intended to have when placed, ie, the "10 mm stent" has a nominal placement diameter of 10 mm). The change in length is divided by the length of the stent when the catheter is loaded (pressure grip) and multiplied by 100. Some self-expanding stents are designed to limit stent shortening to an insignificant amount (eg, less than 10%). However, self-expanding stents can be shortened by significant amounts (eg, more than 10%) due to design, placement environment, and other factors.

當發生明顯的縮短時，將支架佈置在體腔或腔(如脈管、動脈、靜脈或導管)內的其預期軸向位置會更加困難。縮短效應可表現在支架的遠端，當支架在近端佈置在體腔或腔中(例如當支架的遠端擴張並與脈管內壁接合或者兩種情況)時支架的遠端可向近側運動。由於縮短所導致的這些運動，可使支架從其預期位置移位，從而導致佈置在錯誤的或不是最理想的位置。 When a significant shortening occurs, it may be more difficult to position the stent in its intended axial position within a body lumen or lumen, such as a vessel, artery, vein or catheter. The shortening effect can be manifested at the distal end of the stent, and the distal end of the stent can be proximal when the stent is placed proximally in the body lumen or lumen (eg, when the distal end of the stent expands and engages the inner wall of the vessel or both) motion. Due to the shortening of these movements, the stent can be displaced from its intended position, resulting in placement in the wrong or not optimal position.

將自擴張式支架佈置在非預期的位置可能不能解決被治療的疾病，例如當支架未覆蓋脈管的患病部分的全長或者未在動脈瘤上架橋時。在這些情況中所採用的常規策略可包括將另一個支架放置在重疊的位置。然而，這增加了手術的長度和難度。此外，佈置在非預期位置可能例如通過阻礙與另一個脈管的連接而不期望地影響脈管系統的解剖結構。因此，期望將放錯位置的支架重新定位而不是佈置另一個支架。 Arranging the self-expanding stent in an unintended position may not solve the disease being treated, such as when the stent does not cover the full length of the diseased portion of the vessel or does not bridge over the aneurysm. Conventional strategies employed in these situations may include placing another stent in an overlapping position. However, this increases the length and difficulty of the procedure. Moreover, placement at an unintended location may undesirably affect the anatomy of the vasculature, such as by impeding connection to another vessel. Therefore, it is desirable to reposition the misplaced stent instead of arranging another stent.

為了便於使支架重新定位，存在一些技術用於在完全地佈置支架之前將支架再約束在輸送系統的外護套內，並且支架的近端留在外護套內。可通過使外護套在支架上向遠側滑動並且將其徑向地壓縮回到其壓握直徑，而再約束支架。為了對抗由於使護套在支架上行進時的摩擦所產生的護套作用於支架上的軸向力，可約束支架的近端使其不能相對於護套和內構件向遠側運動。一些輸送系統設計提供用於約束支架的近端使其不能向遠側運動的特徵，參見例如2009年10月5日提交的共同未決的共同受讓的美國專利申請序號12/573,527(律師案號FSS5004USNP)和2012年6月12日提交的序號13/494,567(律師案號FSS5004USCIP)，這兩個專利申請以參考的方式併入本文中，以及歐洲專利申請No.0696442 A2和美國專利公開No.2007/0233224 A1。 To facilitate repositioning of the stent, there are techniques for re-constraining the stent within the outer sheath of the delivery system prior to completely arranging the stent, with the proximal end of the stent remaining within the outer sheath. The stent can be re-constrained by sliding the outer sheath distally on the stent and compressing it radially back to its crimping diameter. To counteract the axial forces exerted by the sheath on the stent as a result of the friction of the sheath as it travels over the stent, the proximal end of the stent can be constrained from moving distally relative to the sheath and the inner member. Some delivery system designs provide features for constraining the proximal end of the stent from distal movement, see, for example, co-pending U.S. Patent Application Serial No. 12/573,527, filed on Oct. 5, 2009. FSS5004USNP) and Serial No. 13/494,567 (Attorney Docket No. FSS5004USCIP), filed on Jun. 12, 2012, the disclosure of each of which is hereby incorporated by reference in its entirety, in its entirety, in its entirety, 2007/0233224 A1.

發明概要 Summary of invention

因此，我們已認識到期望的是提供便於再約束局部佈置支架從而允許重新定位的自擴張式支架輸送系統和方法。類似地，期望提供補償支架縮短的自擴張式支架輸送系統和方法。如下面的資料所描述的本公開的技術滿足了這些和其它目的。 Accordingly, we have recognized that it would be desirable to provide a self-expanding stent delivery system and method that facilitates re-constraining the localized stent to allow for repositioning. Similarly, it would be desirable to provide a self-expanding stent delivery system and method that compensates for stent shortening. These and other objects are met by the techniques of the present disclosure as described in the following documents.

本公開包括一種用於佈置和再約束可擴張腔內裝置的脈管內裝置，該裝置具有：殼體；從殼體延伸且能夠相對於殼體做軸向運動的第一細長管狀構件；從殼體延伸且能夠相對於殼體做軸向運動的第二細長管狀構件，第二細長管狀構件具有遠端，遠端帶有徑向突出的遠側限位器，其中，第二細長管狀構件被同軸地設置在第一細長管狀構件內；環狀鎖，環狀鎖構造成在一個操作狀態中固定可擴張腔內裝置而在另一個操作狀態中釋放腔內裝置，其中，環狀鎖被同軸地設置在第二細長管狀構件上並且被同軸地設置在第一管狀構件內，並且其中，環狀鎖具有小於遠側限位器的有效外直徑的內直徑；在殼體上的旋鈕，旋鈕被柔性環構件聯接到第一細長管狀構件，使得旋鈕的操縱使第一細長管狀構件相對於殼體軸向地運動；以及在殼體上的滑動件，滑動件聯接到柔性環構件。 The present disclosure includes an intravascular device for arranging and reconstraining an expandable intraluminal device, the device having: a housing; a first elongate tubular member extending from the housing and axially movable relative to the housing; a second elongate tubular member extending from the housing and axially movable relative to the housing, the second elongate tubular member having a distal end, the distal end having a radially projecting distal stop, wherein the second elongate tubular member Coaxially disposed within the first elongate tubular member; an annular lock configured to secure the expandable intraluminal device in one operational state and to release the intraluminal device in another operational state, wherein the annular lock is Coaxially disposed on the second elongate tubular member and coaxially disposed within the first tubular member, and wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal limiter; a knob on the housing, The knob is coupled to the first elongate tubular member by a flexible loop member such that manipulation of the knob causes the first elongate tubular member to move axially relative to the housing; and a slider on the housing, the slider coupled to Of the ring member.

在一個方面，旋鈕提供機械利益，使得第一細長管狀構件相對於殼體的對應軸向運動小於輸入運動。 In one aspect, the knob provides a mechanical advantage such that the corresponding axial movement of the first elongate tubular member relative to the housing is less than the input motion.

在一個方面，環狀鎖可具有多個凹陷，這些凹陷構造成捕獲可擴張腔內裝置的元件。 In one aspect, the annular lock can have a plurality of depressions configured to capture elements of the device within the expandable lumen.

在一個方面，所述裝置可包括摩擦致動器，摩擦 致動器在殼體的遠側被同軸地設置在第一細長管狀構件上。 In one aspect, the device can include a friction actuator, friction An actuator is coaxially disposed on the first elongate tubular member at a distal side of the housing.

在一個方面，所述裝置可包括被同軸地設置在第二細長管狀構件內且從殼體延伸經過遠側限位器的內細長管狀構件，其中，該內細長管狀構件包括腔管、與腔管流體連通的近側埠以及具有與腔管流體連通的多個孔眼的遠側部分。所述脈管內裝置還可具有錐形的遠側頂端，該遠側頂端具有多個凹槽，這些凹槽構造成當遠側頂端鄰接第一細長管狀構件的遠端時允許從內細長管狀構件的孔眼中供應的流體的流出。 In one aspect, the device can include an inner elongate tubular member that is coaxially disposed within the second elongate tubular member and that extends from the housing through the distal limiter, wherein the inner elongate tubular member includes a lumen, and a lumen The proximal side of the fluid communication tube and the distal portion of the plurality of apertures in fluid communication with the lumen. The intravascular device can also have a tapered distal tip having a plurality of grooves configured to allow for an elongated tubular shape from the inside when the distal tip abuts the distal end of the first elongated tubular member The outflow of fluid supplied in the perforations of the component.

本公開還包括一種可再約束支架輸送系統，該系統具有：殼體；從殼體延伸且能夠相對於殼體做軸向運動的第一細長管狀構件；從殼體延伸且能夠相對於殼體做軸向運動的第二細長管狀構件，第二細長管狀構件具有遠端，遠端帶有徑向突出的遠側限位器，其中，第二細長管狀構件被同軸地設置在第一細長管狀構件內；環狀鎖，環狀鎖被同軸地設置在第二細長管狀構件上且被同軸地設置在第一管狀構件內，其中，環狀鎖具有小於遠側限位器的有效外直徑的內直徑；被可釋放地固定到環狀鎖的自擴張支架；在殼體上的旋鈕，旋鈕被柔性環構件聯接到第一細長管狀構件，使得旋鈕的操縱使第一細長管狀構件相對於殼體軸向地運動；以及在殼體上的滑動件，滑動件聯接到柔性環構件。 The present disclosure also includes a re-constrainable stent delivery system having: a housing; a first elongated tubular member extending from the housing and axially movable relative to the housing; extending from the housing and diaposable relative to the housing a second elongate tubular member that is axially moved, the second elongate tubular member having a distal end, the distal end having a radially projecting distal stop, wherein the second elongate tubular member is coaxially disposed in the first elongate tubular Inside the member; an annular lock, the annular lock being coaxially disposed on the second elongated tubular member and coaxially disposed within the first tubular member, wherein the annular lock has an effective outer diameter that is less than the distal limiter Inner diameter; a self-expanding stent releasably secured to the annular lock; a knob on the housing, the knob coupled to the first elongated tubular member by the flexible loop member, such that manipulation of the knob causes the first elongated tubular member to be opposite the shell The body moves axially; and a slider on the housing, the slider being coupled to the flexible ring member.

本公開還包括一種用於佈置和再約束可擴張腔 內裝置的方法。該方法可包括：提供脈管內裝置，該裝置具有：殼體；從殼體延伸且能夠相對於殼體做軸向運動的第一細長管狀構件；從殼體延伸且能夠相對於殼體做軸向運動的第二細長管狀構件，第二細長管狀構件具有遠端，遠端帶有徑向突出的遠側限位器，其中，第二細長管狀構件被同軸地設置在第一細長管狀構件內；可釋放地固定可擴張腔內裝置的環狀鎖，其中，環狀鎖被同軸地設置在第二細長管狀構件上並且被同軸地設置在第一管狀構件內，並且其中，環狀鎖具有小於遠側限位器的有效外直徑的內直徑；在殼體上的旋鈕，旋鈕被柔性環構件聯接到第一細長管狀構件；以及在殼體上的滑動件，滑動件聯接到柔性環構件；將脈管內裝置的遠端定位在患者脈管系統內的期望位置；並且操縱旋鈕以使第一細長管狀構件相對於殼體軸向地運動以便使可擴張腔內裝置的一部分暴露。 The present disclosure also includes a method for arranging and reconstraining an expandable lumen The method of the inner device. The method can include providing an intravascular device having: a housing; a first elongate tubular member extending from the housing and axially movable relative to the housing; extending from the housing and capable of being opposite the housing An axially moving second elongate tubular member having a distal end with a distally extending distal stop, wherein the second elongate tubular member is coaxially disposed on the first elongate tubular member An annular lock that releasably secures the expandable intraluminal device, wherein the annular lock is coaxially disposed on the second elongated tubular member and coaxially disposed within the first tubular member, and wherein the annular lock An inner diameter having an effective outer diameter that is less than the distal limiter; a knob on the housing, the knob being coupled to the first elongated tubular member by the flexible ring member; and a slide on the housing coupled to the flexible ring a member; positioning a distal end of the intravascular device at a desired location within the patient's vasculature; and manipulating the knob to axially move the first elongate tubular member relative to the housing to enable the expandable intraluminal device A portion of the exposure.

在一個方面，所述方法可包括操縱在殼體上的聯接到柔性環構件的滑動件，以使第一細長管狀構件相對於殼體向近側軸向地運動。 In one aspect, the method can include manipulating a slider coupled to the flexible ring member on the housing to axially move the first elongated tubular member proximally relative to the housing.

在一個方面，可操縱在殼體上的聯接到第二細長管狀構件的第二致動器從而使第二細長管狀構件相對於殼體向近側軸向地運動直到遠側限位器與環狀鎖接合。進一步，可使第一細長管狀構件相對於殼體向遠側運動從而再約束可擴張腔內裝置。在使第一細長管狀構件向遠側軸向地運動的同時可將力施加到第二致動器，以保持遠側限位器與環狀鎖接合。 In one aspect, a second actuator coupled to the second elongate tubular member on the housing is operative to move the second elongate tubular member axially proximally relative to the housing until the distal stop and loop The lock is engaged. Further, the first elongate tubular member can be moved distally relative to the housing to constrain the expandable intraluminal device. A force can be applied to the second actuator while the first elongate tubular member is moved axially distally to maintain the distal limiter engaged with the annular lock.

在一個方面，通達第二致動器可包括去除設置在第二致動器上的蓋，從而當去除蓋時第二致動器是可見的。 In one aspect, accessing the second actuator can include removing a cover disposed on the second actuator such that the second actuator is visible when the cover is removed.

在一個方面，當使第一細長管狀構件相對於殼體向遠側軸向地運動時，可操縱在殼體的遠側被同軸地設置在第一細長管狀構件上的摩擦致動器。 In one aspect, the friction actuator is coaxially disposed on the first elongate tubular member distal to the housing when the first elongate tubular member is moved axially distally relative to the housing.

在一個方面，脈管內裝置可具有被同軸地設置在第二細長管狀構件內且從殼體延伸經過遠側限位器的內細長管狀構件，其中，內細長管狀構件包括腔管、與腔管流體連通的近側埠以及具有與腔管流體連通的多個孔眼的遠側部分。在將脈管內裝置的遠端定位在期望位置之前，可將沖洗流體供應至近側埠從而導致沖洗流體從孔眼流動。脈管內裝置可具有帶多個凹槽的錐形遠側頂端，使得將沖洗流體供應至近側埠導致沖洗流體被傳送經過第三細長管狀構件的孔眼並且當遠側頂端鄰接第一細長管狀構件的遠端時從凹槽流出。 In one aspect, the intravascular device can have an inner elongate tubular member that is coaxially disposed within the second elongate tubular member and that extends from the housing through the distal limiter, wherein the inner elongate tubular member includes a lumen, and a lumen The proximal side of the fluid communication tube and the distal portion of the plurality of apertures in fluid communication with the lumen. The irrigation fluid may be supplied to the proximal helium prior to positioning the distal end of the intravascular device at the desired location to cause irrigation fluid to flow from the orifice. The intravascular device can have a tapered distal tip with a plurality of grooves such that supply of irrigation fluid to the proximal side causes irrigation fluid to be delivered through the aperture of the third elongated tubular member and when the distal tip abuts the first elongated tubular member The distal end flows out of the groove.

10、110、210、310‧‧‧脈管內裝置 10, 110, 210, 310‧‧‧ intravascular devices

12、112、212、312‧‧‧殼體 12, 112, 212, 312‧‧‧ shell

14、114、214、314‧‧‧第一細長管狀構件 14, 114, 214, 314‧‧‧ first elongated tubular member

16、116、216、316‧‧‧第二細長管狀構件 16, 116, 216, 316‧‧‧ second elongated tubular member

18、118、218、318‧‧‧旋鈕 18, 118, 218, 318‧‧ ‧ knob

20、42、120、142、220、242、320、342‧‧‧滑動件 20, 42, 120, 142, 220, 242, 320, 342‧‧ ‧ slides

22、222、322‧‧‧內管狀構件 22, 222, 322‧‧‧ tubular members

24、124、224、324‧‧‧頂端 24, 124, 224, 324 ‧ ‧ top

26、126、226、326‧‧‧腔管 26, 126, 226, 326‧‧‧ lumen

28、128、228、328‧‧‧導絲 28, 128, 228, 328‧‧ ‧ guide wire

30、130、230、330‧‧‧閥 30, 130, 230, 330‧‧‧ valves

32、132、232、332‧‧‧支架 32, 132, 232, 332‧‧‧ bracket

34、134、234、334‧‧‧環狀鎖 34, 134, 234, 334‧‧ ‧ ring lock

36、136、236、336‧‧‧遠側限位器 36, 136, 236, 336 ‧ ‧ distal limiter

38、138、238、338‧‧‧第三細長管狀構件 38, 138, 238, 338‧‧‧ third elongated tubular member

40、140、240、340‧‧‧近側限位器 40, 140, 240, 340‧‧‧ proximal stop

44、144、244、344‧‧‧抓握器 44, 144, 244, 344‧‧ ‧ grippers

46、146、246、346‧‧‧標誌 46, 146, 246, 346 ‧ ‧ signs

48‧‧‧脈管壁 48‧‧‧Vascular wall

50‧‧‧方向控制組件 50‧‧‧ Directional Control Components

52、58、60‧‧‧近端 52, 58, 60‧‧‧ proximal end

54‧‧‧連接桿 54‧‧‧ Connecting rod

56‧‧‧穿梭件、近端 56‧‧‧ shuttle, proximal

56a‧‧‧貫通開口、穿梭件 56a‧‧‧through opening, shuttle

57‧‧‧管狀構件 57‧‧‧Tubular components

57a‧‧‧槽 57a‧‧‧ slot

58a‧‧‧構件；近端 58a‧‧‧ components; proximal end

59a‧‧‧凸形突片 59a‧‧‧ convex tabs

59b‧‧‧***開口 59b‧‧‧ insertion opening

62、64‧‧‧傳動齒輪 62, 64‧‧‧ transmission gear

66‧‧‧惰滑輪 66‧‧‧ idler pulley

68‧‧‧皮帶 68‧‧‧Land

70‧‧‧棘輪；傳動滑輪軸 70‧‧‧ratchet; drive pulley shaft

72‧‧‧聯接件；棘輪；脈管壁 72‧‧‧Connecting parts; ratchet; vessel wall

74‧‧‧第一彈性可偏轉元件 74‧‧‧First elastic deflectable element

76、86‧‧‧端 76, 86‧‧‧

78、88‧‧‧自由端 78, 88‧‧‧Free end

80‧‧‧齒 80‧‧‧ teeth

82‧‧‧第一凸輪 82‧‧‧First Cam

84‧‧‧第二彈性可偏轉元件 84‧‧‧Second elastic deflectable element

90‧‧‧第二凸輪 90‧‧‧second cam

92‧‧‧抓爪 92‧‧‧ gripper

94‧‧‧突出部 94‧‧‧Protruding

350‧‧‧界限標誌 350‧‧‧limit mark

352‧‧‧蓋 352‧‧‧ Cover

354‧‧‧孔眼 354‧‧‧ Eyes

356‧‧‧凹槽 356‧‧‧ Groove

D_c‧‧‧外直徑 D _c ‧‧‧outer diameter

D_nc‧‧‧直徑 D _nc ‧‧‧diameter

L_c、L_nc‧‧‧長度 L _c , L _nc ‧‧‧ length

L-L‧‧‧縱向軸線 L-L‧‧‧ longitudinal axis

進一步的特徵和優點將從如附圖中所示出的本公開優選實施例的以下更具體的說明變得明顯，在附圖中，遍及所有視圖，相同的附圖標記通常指代相同的部件或元件，並且其中：圖1示出了根據實施例的處於初始構造的可再約束支架輸送系統；圖2示出了根據實施例的具有局部佈置的支架的可再約束支架輸送系統； 圖3示出了根據實施例的準備好進行再約束的可再約束支架輸送系統；圖4示出了根據實施例的在再約束期間的可再約束支架輸送系統；圖5示出了根據實施例的在再約束之後的可再約束支架輸送系統；圖6示出了根據實施例的返回到佈置構造的可再約束支架輸送系統；圖7示出了根據實施例的可再約束支架輸送系統的殼體的內部視圖；圖8A示出了根據實施例的可再約束支架輸送系統的致動器元件；圖8B示出了圖8A中所示系統的致動器的替代實施例；圖8C示出了圖8B中的致動器的相關部件的透視圖；圖8D示出了位於手柄的近端的部件的分解透視圖；圖9示出了根據實施例的可再約束支架輸送系統的方向控制組件；圖10示出了根據實施例的處於支架佈置構造的可再約束支架輸送系統的方向控制組件；圖11示出了根據實施例的處於支架再約束構造的可再約束支架輸送系統的方向控制組件； 圖12示出了根據另一個實施例的可再約束支架輸送系統；圖13示出了根據實施例的具有近側限位器的可再約束支架輸送系統；圖14A、14B示出了根據實施例的具有單個埠沖洗的可再約束支架輸送系統；圖15示出了根據實施例的具有單個埠沖洗的可再約束支架輸送系統的端視圖；圖16示出了根據實施例的處於受約束構造的自擴張式支架；並且圖17示出了根據實施例的處於佈置構造的自擴張式支架。 The features and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments illustrated in the appended claims Or an element, and wherein: Figure 1 illustrates a reconstrainable stent delivery system in an initial configuration in accordance with an embodiment; Figure 2 illustrates a re-constrainable stent delivery system having a partially disposed stent in accordance with an embodiment; Figure 3 illustrates a re-constrainable stent delivery system ready for re-constraints in accordance with an embodiment; Figure 4 illustrates a re-constrainable stent delivery system during re-constraints, according to an embodiment; Figure 5 illustrates Re-constrained stent delivery system after re-constraining; Figure 6 illustrates a re-constrainable stent delivery system returning to an arrangement configuration in accordance with an embodiment; Figure 7 illustrates a re-constrainable stent delivery system in accordance with an embodiment Figure 8A shows an actuator element of a re-constrainable stent delivery system in accordance with an embodiment; Figure 8B shows an alternate embodiment of the actuator of the system shown in Figure 8A; Figure 8C A perspective view of the relevant components of the actuator of Fig. 8B is shown; Fig. 8D shows an exploded perspective view of the component at the proximal end of the handle; and Fig. 9 shows a reconstrainable stent delivery system according to an embodiment. Directional control assembly; Figure 10 illustrates a directional control assembly of a re-constrainable stent delivery system in a stent arrangement configuration in accordance with an embodiment; Figure 11 illustrates a reconstrainable stent delivery in a stent re-constrained configuration, in accordance with an embodiment The direction control component of the system; Figure 12 illustrates a re-constrainable stent delivery system in accordance with another embodiment; Figure 13 illustrates a re-constrainable stent delivery system with a proximal restraint in accordance with an embodiment; Figures 14A, 14B illustrate implementations in accordance with an embodiment Example of a re-constrainable stent delivery system with a single fistula irrigation; Figure 15 illustrates an end view of a re-constrainable stent delivery system with a single fistula irrigation in accordance with an embodiment; Figure 16 illustrates being constrained in accordance with an embodiment A self-expanding stent constructed; and Figure 17 illustrates a self-expanding stent in an arrangement configuration in accordance with an embodiment.

較佳實施例之詳細說明 Detailed description of the preferred embodiment

在開始，應該理解的是本公開並不局限於具體例示的材料、架構、例行程序、方法或結構，因為這些可以變化。因此，儘管多個此類選項(類似於或等同於本文中所描述的那些)可以用於本公開的實施或實施例，但本文中描述了優選的材料和方法。 In the beginning, it should be understood that the present disclosure is not limited to the specifically illustrated materials, architecture, routines, methods or structures, as these may vary. Thus, although a plurality of such options (similar or equivalent to those described herein) can be used in the practice or embodiments of the present disclosure, the preferred materials and methods are described herein.

也應當理解的是，本文中所使用的術語只是為了描述本公開的具體實施例的目的，而並非意圖是限制性的。 The terminology used herein is for the purpose of describing the particular embodiments of the embodiments

下面結合附圖所陳述的詳細說明意圖是用作對本公開的示例性實施例的描述，而並非意圖代表可以實施本公開的僅有的示例性實施例。遍及本說明書所使用的術 語”示例性的”指的是”充當示例、例子或例證”，並且不必被理解成比其它示例性實施例更加優選或更加有利。詳細說明包括具體細節，用於提供對本說明書的示例性實施例的詳盡理解的目的。本領域技術人將會理解的是，本說明書的示例性實施例可在沒有這些具體細節的情況下實施。在一些情況下，眾所周知的結構和裝置是以方框圖形式示出，以便避免使本文中給出的示例性實施例的新穎性變得難以理解。 The detailed description set forth below with reference to the drawings is intended to be illustrative of the exemplary embodiments of the present invention, and is not intended to represent the only exemplary embodiments of the present disclosure. Throughout the instructions used in this manual "Exemplary" means "serving as an example, instance or illustration" and is not necessarily to be construed as preferred or advantageous over other exemplary embodiments. The detailed description includes specific details for the purpose of providing a detailed understanding of the exemplary embodiments of the specification. Those skilled in the art will appreciate that the exemplary embodiments of the present specification can be practiced without these specific details. In some instances, well known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the exemplary embodiments presented herein.

僅為了方便和清楚的目的，可關於附圖使用方向性術語，例如頂部、底部、左、右、上、下、在上方、在上面、在下方、在下面、在後面、在背面和在前面。這些和類似的方向性術語不應被理解成以任何方式限制本公開的範圍。 For convenience and clarity only, directional terminology may be used with respect to the figures, such as top, bottom, left, right, up, down, above, above, below, below, behind, behind, and in front. . These and similar directional terms are not to be construed as limiting the scope of the disclosure in any way.

除非另有規定，本文中所使用的全部技術和科學術語具有與本公開所屬領域的技術人員通常所理解的相同的含義。 All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs, unless otherwise specified.

如本文中使用的，術語”可擴張腔內裝置”不僅包括可被另一個裝置(例如球囊)擴張的裝置，而且包括可在無需另一個裝置的情況下能夠自擴張以便擴張到其操作構造的裝置。最後，如本說明書和所附申請專利範圍所使用的，單數形式”一”、”一個”和”該”包括複數所指對象，除非上下文中明確地另有所指。 As used herein, the term "expandable intraluminal device" includes not only devices that can be expanded by another device (eg, a balloon), but also self-expanding that can be expanded to its operational configuration without the need for another device. s installation. The singular forms "a", "the", and "the"

在自擴張式支架與細長管狀構件的內直徑處於摩擦接觸的支架輸送系統(例如包括由鎳鈦諾製成的自擴 張式支架的那些支架輸送系統)中，摩擦可以是相當高的。在不使用對抗作用於支架的近側力的近側限位器或一些其它機構的情況下，將外細長管狀構件向近側拔出可能無法成功地暴露並由此釋放支架。相反，可用管狀構件向近側拉拽支架。因此，大部分的自擴張式支架輸送系統具有所謂的近側限位器的結構，當使外管狀構件向近側平移以暴露並佈置支架時該近側限位器向支架的近端施加相等且相反的力。取決於支架的設計，這可彈簧載入支架抵靠限位器，並且當遠端不再受到外管狀構件的約束時遠端可向遠側彈出。該運動連同擴張時支架的縮短可以導致支架被沿脈管的軸線縱向地佈置在不同於期望位置的位置。當確定了局部佈置的支架處在不是最理想的位置時，為了解決這些和其它情況，本公開的技術提供了一種支架輸送系統，其具有再約束局部佈置的支架從而將支架重新定位以便佈置在更期望位置的能力。 A stent delivery system in which the self-expanding stent is in frictional contact with the inner diameter of the elongated tubular member (eg, including self-expanding made of Nitinol) In those stent delivery systems of the tension bracket, the friction can be quite high. Pulling the outer elongate tubular member proximally without the use of a proximal stop or some other mechanism against the proximal force acting on the stent may not successfully expose and thereby release the stent. Instead, the tubular member can be used to pull the stent proximally. Thus, most self-expanding stent delivery systems have a so-called proximal stopper structure that applies equal force to the proximal end of the stent when the outer tubular member is translated proximally to expose and deploy the stent. And the opposite force. Depending on the design of the bracket, this spring loaded bracket abuts the limiter and the distal end can be ejected distally when the distal end is no longer constrained by the outer tubular member. This movement, along with the shortening of the stent when expanded, can result in the stent being longitudinally disposed at a different location than the desired location along the axis of the vessel. To address these and other situations when it is determined that the partially disposed stent is in a less than optimal position, the techniques of the present disclosure provide a stent delivery system having a re-constrained partially disposed stent to reposition the stent for placement in the The ability to position more.

再約束包括使外管狀構件向遠側行進，使得其在擴張的支架上滑動並且壓縮擴張的支架，直到支架的全長受到約束並且不再與脈管壁接觸。當返回到此構造時，可在沒有拉伸或者以其他方式損傷血管的危險的情況下將支架重新定位。因此，本公開的支架輸送系統可包括近側限位器，以將向遠側的反作用力施加於支架的近端上從而抵消沿與外管狀構件接觸的支架的外直徑的近側摩擦力從而允許拔出管狀構件從而在佈置期間暴露支架。與此同時，本公開的支架輸送系統可具有遠端限位結構，以施加向近 側的作用力，在再約束期間，該向近側的作用力抵消與使管狀構件在支架的外直徑上行進相關聯的向遠側作用的摩擦力。 Reconstraining includes advancing the outer tubular member distally such that it slides over the expanded stent and compresses the expanded stent until the full length of the stent is constrained and no longer contacts the vessel wall. When returning to this configuration, the stent can be repositioned without the risk of stretching or otherwise damaging the blood vessel. Accordingly, the stent delivery system of the present disclosure can include a proximal limiter to apply a distally acting reaction force on the proximal end of the stent to counteract proximal frictional forces along the outer diameter of the stent in contact with the outer tubular member thereby The tubular member is allowed to be pulled out to expose the stent during deployment. At the same time, the stent delivery system of the present disclosure can have a distal stop structure to apply proximally The lateral force, during re-constraining, this proximal force counteracts the distally acting friction associated with advancing the tubular member over the outer diameter of the stent.

當使管狀構件向遠側行進時不能提供足夠的反作用力會具有不期望的後果。例如，在被局部地佈置之後支架的遠端可與脈管壁接觸，使得當使在較小直徑處的支架的一個部分朝向支架的相對不動的擴張直徑遠端行進時，由於與外管狀構件的摩擦所造成的支架的向遠側運動可導致支架的在緊靠約束管狀構件遠端的遠側的那部分反轉進入(局部地)佈置的支架的已釋放的部分。作為另一個例子，與脈管壁接觸的支架的擴張部分可向遠側滑動，從而導致創傷。在本領域中，已知系統用於提供如上所述施加合適的向近側的反作用力的結構。然而，表現出明顯縮短的支架在再約束時可具有顯著的長度增加。因此，當以補償該長度增加的方式再約束支架時，本公開的技術提供作用於支架的近側取向的反作用力。 Failure to provide sufficient reaction force when advancing the tubular member distally can have undesirable consequences. For example, the distal end of the stent can be in contact with the vessel wall after being partially disposed such that when a portion of the stent at a smaller diameter is advanced toward the relatively immovable expanded diameter distal end of the stent, due to the outer tubular member The distal movement of the stent caused by the friction can cause the portion of the stent that is distal to the distal end of the constraining tubular member to reverse into the released portion of the (partially) disposed stent. As another example, the expanded portion of the stent in contact with the vessel wall can slide distally, resulting in a wound. In the art, systems are known for providing a structure that applies a suitable proximal reaction force as described above. However, stents that exhibit a significant shortening can have a significant increase in length when reconstrained. Thus, the technique of the present disclosure provides a reaction force that acts on the proximal orientation of the stent when the stent is reconstrained in a manner that compensates for this increase in length.

一種可再約束支架輸送系統實施例包括如圖1中示意性示出的脈管內裝置10，並且通常可具有：沿縱向軸線L-L延伸的殼體12、從殼體12延伸且能夠相對於殼體12做軸向運動的第一細長管狀構件14(其也可被稱為護套或外構件)以及也從殼體12延伸且能夠相對於殼體14做軸向運動的第二細長管狀構件16。第一細長管狀構件14可具有任何合適的結構，例如擠出聚合物與被包封在聚合物中的加強層(例如金屬編織物)的複合結構，如本領域技術人員所 瞭解的。第二細長管狀構件16被同軸地設置在第一細長管狀構件14內。殼體12承載多個致動器，可操作這些致動器從而實現第一細長管狀構件14和第二細長管狀構件16相對於殼體12的運動。 A reconstrainable stent delivery system embodiment includes an intravascular device 10 as schematically illustrated in Fig. 1, and generally can have a housing 12 extending along a longitudinal axis LL, extending from the housing 12 and capable of being opposite the housing The first elongated tubular member 14 (which may also be referred to as a sheath or outer member) that moves axially within the body 12 and a second elongated tubular member that also extends from the housing 12 and is axially movable relative to the housing 14 16. The first elongate tubular member 14 can have any suitable structure, such as a composite structure of an extruded polymer and a reinforcing layer (e.g., a metal braid) encapsulated in a polymer, as will be appreciated by those skilled in the art. understand. The second elongate tubular member 16 is coaxially disposed within the first elongate tubular member 14. The housing 12 carries a plurality of actuators that are operable to effect movement of the first elongated tubular member 14 and the second elongated tubular member 16 relative to the housing 12.

如圖中所示，第一致動器構造成旋鈕18。例如，旋鈕18可以是由短圓柱體形成的撥輪，該撥輪可具有壓花的或者有紋理的外直徑以便在無滑動的情況下協助將力從操作者傳遞到撥輪。取決於使旋鈕18旋轉的方向，可使第一細長管狀構件14相對於殼體12前進或者退出。在此實施例中，第二致動器構造成滑動件20(例如突片、按鈕或旋鈕)。滑動件20可聯接到第二細長管狀構件16，從而滑動件20在近側方向的運動使第二細長管狀構件16相對於殼體12退出，並且滑動件20在遠側方向上的運動使第二細長管狀構件16相對於殼體12前進。 As shown in the figures, the first actuator is configured as a knob 18. For example, the knob 18 can be a dial formed of a short cylinder that can have an embossed or textured outer diameter to assist in transferring force from the operator to the dial without slippage. The first elongate tubular member 14 can be advanced or withdrawn relative to the housing 12 depending on the direction in which the knob 18 is rotated. In this embodiment, the second actuator is configured as a slider 20 (eg, a tab, button or knob). The slider 20 can be coupled to the second elongated tubular member 16 such that movement of the slider 20 in the proximal direction causes the second elongated tubular member 16 to withdraw relative to the housing 12, and movement of the slider 20 in the distal direction causes The two elongated tubular members 16 are advanced relative to the housing 12.

通常，滑動件20可聯接到第二細長管狀構件16，從而滑動件20的直線運動以1：1的比率被轉化成第二細長管狀構件16的直線運動。滑動件20具有從最遠側位置到最近側位置的行進範圍。正如將下面在一些實施例中所描述的，當處在其最遠側位置時，滑動件20接合與旋鈕18相關聯的方向控制件(圖1中未示出)，使得旋鈕18只可在相對於殼體12拔出第一細長管狀構件14的方向上旋轉。相應地，第一細長管狀構件14的運動被限制到向近側運動。當滑動件20從其最遠側位置向近側運動時，其與方向控制件脫離接合，使得旋鈕18只可在使第一細長管狀構件14前進的方 向上旋轉，從而將第一細長管狀構件14限制為僅做向遠側運動。 Generally, the slider 20 can be coupled to the second elongated tubular member 16 such that linear motion of the slider 20 is converted to linear motion of the second elongated tubular member 16 at a ratio of 1:1. The slider 20 has a travel range from the most distal position to the most proximal position. As will be described below in some embodiments, when in its most distal position, the slider 20 engages a directional control (not shown in Figure 1) associated with the knob 18 such that the knob 18 is only available Rotation in the direction in which the first elongated tubular member 14 is withdrawn from the housing 12. Accordingly, the movement of the first elongated tubular member 14 is restricted to move proximally. When the slider 20 is moved proximally from its most distal position, it disengages from the directional control member such that the knob 18 can only advance the first elongated tubular member 14 Rotating upwardly limits the first elongate tubular member 14 to only distal movement.

內管狀構件22也可從殼體12延伸並且具有與殼體的固定關係，從而在其遠端終止於擴大的錐形頂端24，該錐形頂端可以是一體的或分開的並且也可被稱為鼻錐或擴張器。內管狀構件22具有在其近端與其遠端之間延伸的腔管26。內管狀構件可由用於導絲管的聚醯亞胺或者本領域技術人員已知的聚合物的其它組合製成。在一個方面，遠側頂端24可以是不透射線的。腔管26的尺寸可被設置成在導絲28上緊密地跟隨。如圖中所示，導絲28可從殼體12中經過密封的閥30(例如魯爾鎖)向近側延伸，該閥30與腔管26流體連通並且導絲28也可向遠側延伸超過頂端24。在不使用導絲的實施例中，內構件可以是無腔管的實心細長圓柱形構件。 The inner tubular member 22 can also extend from the housing 12 and have a fixed relationship with the housing to terminate at its distal end at an enlarged tapered tip end 24, which can be integral or separate and can also be referred to as For a nose cone or dilator. The inner tubular member 22 has a lumen 26 extending between its proximal end and its distal end. The inner tubular member can be made from a polyimine of a guidewire or other combination of polymers known to those skilled in the art. In one aspect, the distal tip 24 can be radiopaque. The lumen 26 can be sized to closely follow the guidewire 28. As shown, the guidewire 28 can extend proximally from the housing 12 through a sealed valve 30 (e.g., a Luer lock) that is in fluid communication with the lumen 26 and that the guidewire 28 can also extend distally. More than the top 24. In embodiments where a guidewire is not used, the inner member can be a solid elongated cylindrical member without a lumen.

可將支架32設置在第一細長管狀構件14的遠端內，使得第一細長管狀構件14的內直徑將支架32約束在其壓握形狀。當被壓握時，支架32與環狀鎖34接合，從而限制支架32相對於環狀鎖34的縱向運動，並且在佈置期間當支架32擴張時，其從環狀鎖34釋放。環狀鎖34可具有小於第一細長管狀構件14的內直徑的最大外尺寸，以在通過分別拔出第一細長管狀構件14或者使第一細長管狀構件14前進而進行的支架32的佈置或再約束期間減小摩擦。 The stent 32 can be disposed within the distal end of the first elongate tubular member 14 such that the inner diameter of the first elongate tubular member 14 constrains the stent 32 in its crimped shape. When clamped, the bracket 32 engages the ring lock 34 to limit longitudinal movement of the bracket 32 relative to the ring lock 34 and is released from the ring lock 34 when the bracket 32 is expanded during deployment. The annular lock 34 can have a largest outer dimension that is smaller than the inner diameter of the first elongated tubular member 14 to facilitate placement of the bracket 32 by either pulling out the first elongated tubular member 14 or advancing the first elongated tubular member 14, respectively. Friction is reduced during reconstraint.

第二細長管狀構件16的遠端延伸超過環狀鎖34並且包括徑向突出的遠側限位器36，遠側限位器36具有大 於環狀鎖34的內直徑的有效外直徑，使得第二細長管狀構件16的向近側運動可導致遠側限位器36與環狀鎖34接合。當把支架壓握時遠側限位器36的外尺寸小於支架32的內直徑，從而可在沒有來自支架32的干擾的情況下使遠側限位器36移動到環狀鎖34的遠側。可將任何合適的結構用於第二細長管狀構件16，包括例如編織物加強的聚醯亞胺。當滑動件20處在相對於殼體12的其最遠側位置時，遠側限位器36可處在與環狀鎖34的初始位置間隔期望距離的預定位置處，以適應在佈置期間當使支架32擴張時由於縮短所造成的環狀鎖34的向遠側運動。 The distal end of the second elongate tubular member 16 extends beyond the annular lock 34 and includes a radially protruding distal stop 36, the distal limiter 36 having a large The effective outer diameter of the inner diameter of the annular lock 34 such that proximal movement of the second elongated tubular member 16 can cause the distal limiter 36 to engage the annular lock 34. The outer dimension of the distal limiter 36 is less than the inner diameter of the bracket 32 when the bracket is crimped so that the distal limiter 36 can be moved to the distal side of the annular lock 34 without interference from the bracket 32. . Any suitable structure can be used for the second elongate tubular member 16, including, for example, a woven reinforced polyimide. When the slider 20 is in its most distal position relative to the housing 12, the distal stop 36 can be at a predetermined position spaced a desired distance from the initial position of the ring lock 34 to accommodate during deployment. The distal movement of the annular lock 34 due to the shortening when the stent 32 is expanded.

第三細長管狀構件38也可以以固定關係從殼體12延伸，具有遠端，該遠端具有構造成從近側方向與環狀鎖34接合的直徑，使得第三細長管狀構件38的端部充當近側限位器40。第三細長管狀構件38可被同軸地設置在第一細長管狀構件14內並且被同軸地設置在第二細長管狀構件16上。因為第三細長管狀構件38具有與殼體12的固定關係，所以遠側限位器40也保持固定位置，而當適當地操縱旋鈕18和滑動件20時，可分別使第一細長管狀構件14和第二細長管狀構件16連同遠側限位器36相對於其前進或者退出。第三細長管狀構件38可具有在長度上變化的物理性質，例如通過具有由聚合材料形成的相對易彎曲的遠側長度和由不銹鋼海波管形成的相對剛性的近側長度。在替代的結構中，第三細長管狀構件38可在全長上具有基本恒定的柔性的物理性質。可用於第三細長管狀構件38的結構的 合適聚合材料的一個例子是聚醚醚酮(PEEK)。 The third elongate tubular member 38 can also extend from the housing 12 in a fixed relationship having a distal end having a diameter configured to engage the annular lock 34 from a proximal direction such that the end of the third elongate tubular member 38 Acts as a proximal limiter 40. A third elongate tubular member 38 can be disposed coaxially within the first elongate tubular member 14 and coaxially disposed on the second elongate tubular member 16. Because the third elongate tubular member 38 has a fixed relationship with the housing 12, the distal limiter 40 also maintains a fixed position, and when the knob 18 and the slider 20 are properly manipulated, the first elongate tubular member 14 can be respectively engaged And the second elongated tubular member 16 along with the distal limiter 36 advances or exits relative thereto. The third elongate tubular member 38 can have physical properties that vary in length, such as by having a relatively flexible distal length formed from a polymeric material and a relatively rigid proximal length formed by a stainless steel hypotube. In an alternative configuration, the third elongate tubular member 38 can have substantially constant flexible physical properties over the entire length. Can be used for the structure of the third elongated tubular member 38 An example of a suitable polymeric material is polyetheretherketone (PEEK).

在所示的實施例中，殼體12具有採用快速佈置滑動件42的形式的另一個致動器。正如將在下面詳細地描述，滑動件42可被固定到殼體12內的第一細長管狀構件14，使得操作者可操縱滑動件42以實現第一細長管狀構件14的1：1相對運動以便佈置或者再約束支架32。快速佈置滑動件42可具有在殼體12上的行進範圍，其足以允許將第一細長管狀構件14完全地退出從而完全地暴露支架32以便佈置。可存在超過此長度的行進範圍的近側界限。在示出的實施例中，快速佈置滑動件42的輪廓不延伸超過殼體12的最外表面以降低由於突出結構卡在某物體上而引起的滑動件的非預期平移的可能性。 In the illustrated embodiment, the housing 12 has another actuator in the form of a quick-disposed slider 42. As will be described in detail below, the slider 42 can be secured to the first elongate tubular member 14 within the housing 12 such that an operator can manipulate the slider 42 to effect a 1:1 relative movement of the first elongate tubular member 14 so that The bracket 32 is placed or re-constrained. The quick-displacement slider 42 can have a range of travel on the housing 12 that is sufficient to allow the first elongate tubular member 14 to be fully withdrawn to completely expose the bracket 32 for placement. There may be a near limit to the range of travel beyond this length. In the illustrated embodiment, the profile of the quick-disposed slider 42 does not extend beyond the outermost surface of the housing 12 to reduce the likelihood of unintended translation of the slider due to the protruding structure being stuck on an object.

在另一方面，脈管內裝置10還可具有採用抓握器44形式的摩擦致動器，以促進第一細長管狀構件14的直接操縱。在一個實施例中，抓握器44可由被同軸地設置在第一細長管狀構件14上的彈性聚合材料形成。通常，抓握器44位於殼體12的遠側，但仍然位於患者的進入點的近側。儘管抓握器44可同軸地沿第一細長管狀構件14滑動，但當施加向內的壓力時抓握器44可顯示與第一細長管狀構件14的更大程度的摩擦並且允許手動地使管狀構件前進或退出。例如，如果單獨地操縱殼體12上的致動器以實現第一細長管狀構件14或其它管狀構件的期望運動，在患者身體外的第一細長管狀構件14的長度可能使得脈管內裝置10的管狀部分將傾向於彎曲。因此，抓握器44允許在距離患者 身體近得多的位置將力施加到第一細長管狀構件14以降低任何彎曲傾向。 In another aspect, the intravascular device 10 can also have a friction actuator in the form of a gripper 44 to facilitate direct manipulation of the first elongate tubular member 14. In one embodiment, the gripper 44 can be formed from an elastic polymeric material that is disposed coaxially on the first elongate tubular member 14. Typically, the gripper 44 is located distally of the housing 12, but is still proximal to the patient's entry point. While the gripper 44 can slide coaxially along the first elongate tubular member 14, the gripper 44 can exhibit a greater degree of friction with the first elongate tubular member 14 when applied inward pressure and allows for manual tubular The component advances or exits. For example, if the actuator on the housing 12 is manipulated separately to achieve the desired movement of the first elongate tubular member 14 or other tubular member, the length of the first elongate tubular member 14 outside of the patient's body may cause the intravascular device 10 The tubular portion will tend to bend. Therefore, the gripper 44 allows the distance to the patient A much closer position of the body applies a force to the first elongate tubular member 14 to reduce any tendency to bend.

只作為例子並且不是限制性的，操作者可通過操作旋鈕18而啟動支架32的佈置，這可提供機械利益以允許更大程度地控制第一細長管狀構件14的運動。一旦操作者對支架32的放置滿意，則可能希望操縱快速佈置滑動件42以完成第一細長管狀構件14的拔出並釋放支架32。然而，如果在完成佈置之前希望再約束支架32，則操作者可在相反的方向上操縱旋鈕18和/或使用抓握器44以使第一細長管狀構件14在支架32上反方向前進。 By way of example only and not limitation, an operator can initiate the placement of the bracket 32 by operating the knob 18, which can provide a mechanical advantage to allow for greater control of the movement of the first elongated tubular member 14. Once the operator is satisfied with the placement of the bracket 32, it may be desirable to manipulate the quick-disposed slider 42 to complete the extraction of the first elongated tubular member 14 and release the bracket 32. However, if it is desired to constrain the bracket 32 before completing the arrangement, the operator can manipulate the knob 18 in the opposite direction and/or use the gripper 44 to advance the first elongated tubular member 14 in the opposite direction on the bracket 32.

為了便於將支架32放置在患者脈管系統內的期望位置，可將一個或多個不透射線標誌固定到脈管內裝置10的管狀構件的(一個或多個)位置。例如，在內管狀構件22上示出了標誌46。儘管只為了說明的目的而圖示為位於遠側限位器36的遠側，但標誌46可根據需要而定位以提供關於支架32的放置的回饋和/或指示在再約束支架32之前可將第一細長管狀構件14拔出的限量可能不再是實用的或安全的。 To facilitate placement of the stent 32 at a desired location within the patient's vasculature, one or more radiopaque markers can be secured to the location(s) of the tubular member of the intravascular device 10. For example, the indicia 46 is shown on the inner tubular member 22. Although illustrated for the purpose of illustration only on the distal side of the distal limiter 36, the marker 46 can be positioned as needed to provide feedback and/or indication of placement of the stent 32 prior to reconstraining the stent 32 The limitation of the first elongated tubular member 14 being pulled out may no longer be practical or safe.

正如將會理解的，標誌46可構造為近側放置標誌，用於輸送系統的初始定位並且在第一細長管狀構件14的收回期間用於佈置支架32。可將近側放置標誌用作軸向位置的指示，在該軸向位置處，如果被佈置到其標稱直徑那麼支架的近端將靠在脈管壁上。因為內管狀構件22保持相對於殼體12固定，所以在手術期間標誌46可保持不變。 估計支架的近端所到達的位置對於操作者是有用資訊，並且在手術期間使近側放置標誌有時軸向地運動可以導致在放置支架時的錯誤，或者不必要地再約束和再佈置，如果這種運動不是由操作者所導致的。 As will be appreciated, the marker 46 can be configured as a proximal placement marker for initial positioning of the delivery system and for arranging the stent 32 during retraction of the first elongated tubular member 14. The proximal placement marker can be used as an indication of the axial position at which the proximal end of the stent will rest against the vessel wall if placed to its nominal diameter. Because the inner tubular member 22 remains fixed relative to the housing 12, the indicia 46 can remain unchanged during the procedure. Estimating where the proximal end of the stent is reached is useful information for the operator, and sometimes causing the proximal placement marker to move axially during surgery can result in errors in placing the stent, or unnecessarily constraining and rearranging, If this movement is not caused by the operator.

在另一方面，標誌46可被定位成充當再約束界限標誌，如所述的。這通過指示第一細長管狀構件14的最遠的收回(在此之後仍然可以可靠地再約束支架32)而對於操作者是有用資訊，並且可以在觀察螢光檢查儀時被看見(顯示在靶區中的所有不透射線結構)。如下面所討論的，再約束界限標誌可以相對於快速佈置滑動件42的位置替代地或者另外地定位在殼體12上。 In another aspect, the marker 46 can be positioned to act as a re-constrained boundary marker, as described. This is useful information for the operator by indicating the farthest retraction of the first elongate tubular member 14 (after which the bracket 32 can still be reliably re-constrained) and can be seen while viewing the fluoroscopy (displayed at the target) All radiopaque structures in the area). As discussed below, the re-constrained boundary mark can be alternatively or additionally positioned on the housing 12 relative to the position of the quick-disposed slider 42.

圖1的構造示出了脈管內裝置10準備好在導絲28上前進到患者脈管系統中的期望位置以便佈置支架32，例如在由脈管壁48所限定的體腔內。如圖所示，環狀鎖34被近側限位器40接合，從而當把第一細長管狀構件14拔出時阻止支架32的向近側運動。圖2-6中示意性地示出包括旋鈕18和滑動件20的致動器的示例性操作和操縱，以及在脈管內裝置10的遠端佈置並再約束支架32所形成的效果。在身體中的初始構造中使環狀鎖34鄰接近側限位器36的益處是當把遠側不透射線的支架標誌設置在目標位置時操作者可立即開始收回第一細長管狀構件14，而不必在佈置之前將近側限位器與環狀鎖之間的間隙封閉。這簡化了手術並縮短了與手術相關的時間，並且隨之而來提供了患者可暴露輻射量的減小。 The configuration of Figure 1 shows that the intravascular device 10 is ready to advance over the guidewire 28 to a desired location in the patient's vasculature to position the stent 32, such as within a body lumen defined by the vessel wall 48. As shown, the annular lock 34 is engaged by the proximal stop 40 to prevent proximal movement of the stent 32 when the first elongated tubular member 14 is withdrawn. Exemplary operations and manipulations of the actuator including the knob 18 and the slider 20 are schematically illustrated in Figures 2-6, as well as the effect of arranging and constraining the stent 32 at the distal end of the intravascular device 10. A benefit of having the annular lock 34 adjacent the side stop 36 in the initial configuration in the body is that the operator can immediately begin retracting the first elongated tubular member 14 when the distal radiopaque stent marker is placed at the target position, It is not necessary to close the gap between the proximal stopper and the ring lock before the arrangement. This simplifies the procedure and shortens the time associated with the procedure, and in turn provides a reduction in the amount of radiation that the patient can expose.

開始於圖2，一旦使脈管內裝置10前進到患者脈管系統內的期望位置，則如圖所示操作者可使旋鈕18旋轉(和/或操縱快速佈置滑動件42)以拔出第一細長管狀構件14。當從支架32拔出第一細長管狀構件14時，支架32的不受約束的部分在脈管內擴張，從而與體腔的脈管壁48接觸。由於這是明顯縮短的支架，所以支架32的全長已經縮短，並且該縮短的至少一部分已經發生在第一細長管狀構件14內。已擴張到與脈管壁48接觸的支架32的遠端可在脈管內保持相對不動。因此，如圖所示，支架32的近端和可釋放地固定的環狀鎖34已在第一細長管狀構件14內向遠側軸向地平移達近側限位器40與環狀鎖34之間的空間，該近側限位器40相對於殼體12和患者可以是固定的。 Beginning with Figure 2, once the intravascular device 10 is advanced to a desired position within the patient's vasculature, the operator can rotate the knob 18 (and/or manipulate the rapid placement slider 42) to pull out the first An elongated tubular member 14. When the first elongate tubular member 14 is withdrawn from the stent 32, the unconstrained portion of the stent 32 expands within the vessel to contact the vessel wall 48 of the body lumen. Since this is a significantly shortened stent, the overall length of the stent 32 has been shortened and at least a portion of this shortening has occurred within the first elongated tubular member 14. The distal end of the stent 32 that has been expanded into contact with the vessel wall 48 can remain relatively immobile within the vessel. Thus, as shown, the proximal end of the stent 32 and the releasably securable annular lock 34 have been translated distally axially within the first elongate tubular member 14 to the proximal stop 40 and the annular lock 34. The space between the proximal stops 40 can be fixed relative to the housing 12 and the patient.

第二細長管狀構件16和相應地遠側限位器36的位置保持相對不動，遠側限位器36位於推送器管近側限位器40的遠端的足夠遠側處，該支架32的縮短不會把環狀鎖34推送成與其接觸或者限制由於縮短所造成的支架32的向遠側運動。如果操作者對所佈置支架的位置滿意，那麼第一細長管狀構件14可被完全地收回支架32的近端，從而允許其擴張成沿其全長與脈管48接觸並且由於徑向擴張而從環狀鎖34釋放。正如可以看見的，當把第一細長管狀構件14拔出時，快速佈置滑動件42也已相對於殼體12向近側平移。根據需要，可利用旋鈕18和滑動件42中的一者或兩者實現支架32的佈置。 The position of the second elongate tubular member 16 and the corresponding distal stop 36 remain relatively immobile, the distal stop 36 being located at a sufficient distal end of the distal end of the pusher tube proximal stop 40, the holder 32 Shortening does not push the ring lock 34 into contact with it or limit the distal movement of the bracket 32 due to the shortening. If the operator is satisfied with the position of the deployed stent, the first elongated tubular member 14 can be fully retracted proximally of the stent 32, allowing it to expand into contact with the vessel 48 along its entire length and from the annulus due to radial expansion. The lock 34 is released. As can be seen, the quick deployment slider 42 has also been translated proximally relative to the housing 12 when the first elongated tubular member 14 is withdrawn. The arrangement of the brackets 32 can be achieved with one or both of the knob 18 and the slider 42 as desired.

替代地，如果期望將支架32重新定位並且第一細 長管狀構件14尚未被拔出經過合適的再約束界限標誌(如標誌46)，則可以如關於圖3-5所描述的來實施支架32的再約束。為了如圖3中示意性地示出的開始再約束操作，可操縱滑動件20從殼體12上的其最遠側位置向近側運動。當滑動件20向近側運動時，其導致第二細長管狀構件16的對應的向近側運動直到遠側限位器36與環狀鎖34接合。當遠側限位器36與環狀鎖34接觸時，可感覺到阻力。由於縮短，當已佈置了較大部分的支架32時，滑動件20的相對較小的向近側運動會與使遠側限位器36與環狀鎖34接合有關。正如將在下面更詳細地描述，使滑動件20向近側移位可使與旋鈕18相關聯的方向控制件脫離接合，從而允許使第一細長管狀構件14前進同時防止進一步的拔出。 Alternatively, if it is desired to reposition the bracket 32 and the first The long tubular member 14 has not been pulled out through a suitable reconstrained boundary mark (e.g., indicia 46), and the re-constraint of the bracket 32 can be implemented as described with respect to Figures 3-5. To initiate the re-constraining operation as schematically illustrated in Figure 3, the steerable slide 20 is moved proximally from its most distal position on the housing 12. As the slider 20 moves proximally, it causes a corresponding proximal movement of the second elongated tubular member 16 until the distal limiter 36 engages the annular lock 34. When the distal limiter 36 is in contact with the ring lock 34, resistance can be felt. Due to the shortening, when a larger portion of the bracket 32 has been deployed, the relatively small proximal movement of the slider 20 can be associated with engaging the distal limiter 36 with the annular lock 34. As will be described in more detail below, displacing the slider 20 proximally can disengage the directional control associated with the knob 18, thereby allowing the first elongated tubular member 14 to advance while preventing further extraction.

接著，圖4示意性地示出了第一細長管狀構件14前進以再約束支架32。可通過操縱旋鈕18和/或滑動件42而實施第一細長管狀構件14的前進。然而，由於可能發生在與患者或其它來源對接的導引器的止血閥處的摩擦，所期望的是操縱抓握器44以將第一細長管狀構件14推送到患者的身體內，從而導致其在支架32上前進並且再約束支架32。如上所述，抓握器44可位於相對靠近導引器的位置以降低當施加推力時第一細長管狀構件14發生彎曲的傾向。 Next, FIG. 4 schematically illustrates the advancement of the first elongated tubular member 14 to constrain the bracket 32. Advancing of the first elongate tubular member 14 can be accomplished by manipulating the knob 18 and/or the slider 42. However, since friction at the hemostatic valve of the introducer that interfaces with the patient or other source may occur, it is desirable to manipulate the grasper 44 to push the first elongated tubular member 14 into the body of the patient, thereby causing it The bracket 32 is advanced and the bracket 32 is constrained. As noted above, the gripper 44 can be positioned relatively close to the introducer to reduce the tendency of the first elongate tubular member 14 to flex when a thrust is applied.

操作者可利用觸覺回饋來保持滑動件20上的期望水準的張力，從而保持遠側限位器36與環狀鎖34的接合並且補償當支架長度由於被再約束而增加時支架32的任何相對的向近側運動。用期望量的近側力保持遠側限位器36 與環狀鎖34接觸可將支架32保持在張緊狀態並且協助第一細長管狀構件14在支架32上前進而不是將支架32的受約束部分向遠側推送，這可能導致支架在脈管系統中的非預期運動。施加到遠側限位器36的近側力並非意圖將支架32向近側拉拽。由於第一細長管狀構件14與旋鈕18和滑動件42之間的聯接，不論操作者是否操縱致動器或者使用抓握器44來實現前進，第一細長管狀構件14的前進導致旋鈕18的旋轉和滑動件42在所指示方向上的運動。當操作者施加力以將遠側限位器36保持成與環狀鎖34接合時，滑動件20也可向近側運動，並且當被再約束時支架32變長。 The operator can utilize tactile feedback to maintain a desired level of tension on the slider 20, thereby maintaining engagement of the distal limiter 36 with the ring lock 34 and compensating for any relative position of the bracket 32 as the bracket length increases due to being re-constrained. Move to the side. Maintaining the distal stop 36 with a desired amount of proximal force Contact with the annular lock 34 maintains the stent 32 in tension and assists the first elongated tubular member 14 on the stent 32 rather than pushing the constrained portion of the stent 32 distally, which may result in the stent being in the vasculature Unexpected movement in the middle. The proximal force applied to the distal stop 36 is not intended to pull the stent 32 proximally. Due to the coupling between the first elongate tubular member 14 and the knob 18 and the slider 42, the advancement of the first elongate tubular member 14 results in rotation of the knob 18 whether or not the operator manipulates the actuator or uses the gripper 44 to effect advancement. And the movement of the slider 42 in the indicated direction. When the operator applies a force to hold the distal stop 36 into engagement with the annular lock 34, the slider 20 can also move proximally and the bracket 32 becomes longer when re-constrained.

當第一細長管狀構件14已在支架32的全長上前進時，脈管內裝置10可處於圖5中示意性地示出的構造。遠側限位器36仍然可與環狀鎖34接合，並且滑動件20可定位在相對於殼體的其最遠側位置的近側。然而，第一細長管狀構件14以及滑動件20已返回到它們的初始位置，支架32被完全徑向約束。隨後，如圖6中示意性地示出，操作者可操縱滑動件20以使其返回到相對於殼體12的其最遠側位置。這導致第二細長管狀構件16相對於近側限位器40向遠側前進，從而使脈管內裝置10返回到圖1中所示的構造，從而可根據需要將支架32重新定位。在具有方向控制件的實施例中，使滑動件20返回到其最遠側位置會使方向控制件重新接合，從而第一細長管狀構件14可被拔出並且不前進。 When the first elongate tubular member 14 has advanced over the entire length of the stent 32, the intravascular device 10 can be in the configuration shown schematically in FIG. The distal stop 36 can still engage the annular lock 34 and the slider 20 can be positioned proximal to its most distal position relative to the housing. However, the first elongate tubular member 14 and the slider 20 have returned to their original positions and the bracket 32 is fully radially constrained. Subsequently, as shown schematically in FIG. 6, the operator can manipulate the slider 20 to return it to its most distal position relative to the housing 12. This causes the second elongate tubular member 16 to advance distally relative to the proximal stop 40, thereby returning the intravascular device 10 to the configuration shown in Figure 1, so that the stent 32 can be repositioned as desired. In embodiments having a directional control, returning the slider 20 to its most distal position causes the directional control to re-engage so that the first elongated tubular member 14 can be pulled out and not advanced.

對於一個實施例，圖7-11中示出了關於殼體12及其致動器的合適實施方式的進一步細節。開始於圖7，示出 了殼體12的示意性剖開圖。旋鈕18(在此視圖中為了清楚起見被去除)與方向控制組件50相關聯，如下面所描述的，方向控制組件50進而聯接到第一細長管狀構件14的近端52。近端52還直接地聯接到快速佈置滑動件42。利用連接桿54將滑動件20聯接到第二細長管狀構件16的近端56。第三細長管狀構件38的近端58在第一細長管狀構件14和第二細長管狀構件16的近端之間的位置附著到殼體12。在第二細長管狀構件16的近端56的近側，內管狀構件22的近端60附著到殼體12。 For an embodiment, further details regarding a suitable embodiment of the housing 12 and its actuator are shown in Figures 7-11. Beginning with Figure 7, it is shown A schematic cross-sectional view of the housing 12 is shown. Knob 18 (which is removed for clarity in this view) is associated with directional control assembly 50, which in turn is coupled to proximal end 52 of first elongate tubular member 14, as described below. The proximal end 52 is also directly coupled to the quick deployment slider 42. The slider 20 is coupled to the proximal end 56 of the second elongated tubular member 16 by a connecting rod 54. The proximal end 58 of the third elongate tubular member 38 is attached to the housing 12 at a location between the proximal ends of the first elongate tubular member 14 and the second elongate tubular member 16. On the proximal side of the proximal end 56 of the second elongate tubular member 16, the proximal end 60 of the inner tubular member 22 is attached to the housing 12.

如上所述，該構造允許第一細長管狀構件14和第二細長管狀構件16相對於殼體12獨立地前進或拔出，而第三細長管狀構件38和內管狀構件22具有固定的相對位置。第一細長管狀構件14被同軸地設置在第三細長管狀構件38上，該第三細長管狀構件38被同軸地設置在第二細長管狀構件16上，第二細長管狀構件16進而被同軸地設置在內管狀構件22上。方向控制組件50包括傳動齒輪62，該傳動齒輪62與旋鈕18共用一個軸並且被固定到旋鈕18，從而旋鈕18和傳動齒輪62一起旋轉。傳動齒輪62的齒與傳動滑輪64嚙合從而將旋鈕18的旋轉運動轉移到傳動滑輪64。柔性環構件(在此視圖中未示出)被設置在傳動滑輪64周圍和惰滑輪66周圍。滑動件42被柔性環構件承載並且被固定到第一細長管狀構件14的近端52，如所述的。如果需要，可調節齒輪比和/或滑輪直徑而提供機械利益，從而便於第一細長管狀構件14的拔出和/或前進，如上所述。例如，可減小來 自旋鈕18的旋轉輸入，以輸出減小的線性輸出並且對第一細長管狀構件14的運動施加更大的控制。替代地，根據需要，可增加給定的旋轉輸入，以實現更快速的拔出或者前進。 As described above, this configuration allows the first elongate tubular member 14 and the second elongate tubular member 16 to be independently advanced or withdrawn relative to the housing 12, while the third elongate tubular member 38 and the inner tubular member 22 have a fixed relative position. The first elongate tubular member 14 is coaxially disposed on a third elongate tubular member 38 that is coaxially disposed on the second elongate tubular member 16, which in turn is coaxially disposed On the inner tubular member 22. The directional control assembly 50 includes a drive gear 62 that shares a shaft with the knob 18 and is secured to the knob 18 such that the knob 18 and the drive gear 62 rotate together. The teeth of the drive gear 62 mesh with the drive pulley 64 to transfer the rotational motion of the knob 18 to the drive pulley 64. A flexible ring member (not shown in this view) is disposed about the drive pulley 64 and around the idler pulley 66. The slider 42 is carried by the flexible ring member and is secured to the proximal end 52 of the first elongate tubular member 14, as described. If desired, the gear ratio and/or pulley diameter can be adjusted to provide a mechanical advantage to facilitate the extraction and/or advancement of the first elongate tubular member 14, as described above. For example, can be reduced The rotational input from the knob 18 is output to output a reduced linear output and exert greater control over the motion of the first elongated tubular member 14. Alternatively, a given rotational input can be added as needed to achieve faster extraction or advancement.

圖8A中示意性地示出了柔性環驅動系的元件，在此實施例中柔性環構件被實施為皮帶68。正如將理解的，柔性環構件也可以是V型帶、有齒皮帶、鏈條、筋或者任何其它合適的構造。皮帶68在傳動滑輪64和惰滑輪66的周圍行進。此外，皮帶68被固定到滑動件42，該滑動件42進而被固定到第一細長管狀構件14的近端52。因此，旋鈕18的旋轉運動被轉換成直線運動從而根據旋轉方向使第一細長管狀構件14前進或者拔出。柔性環構件可處在充分的張緊狀態下以便賦予與傳動滑輪軸70的期望程度的摩擦。 The elements of the flexible ring drive train are schematically illustrated in Figure 8A, which in this embodiment is implemented as a belt 68. As will be appreciated, the flexible ring member can also be a V-belt, a toothed belt, a chain, a rib, or any other suitable configuration. Belt 68 travels around drive pulley 64 and idler pulley 66. In addition, the belt 68 is secured to the slider 42, which in turn is secured to the proximal end 52 of the first elongated tubular member 14. Therefore, the rotational motion of the knob 18 is converted into a linear motion to advance or pull out the first elongated tubular member 14 in accordance with the rotational direction. The flexible ring member can be in a sufficiently tensioned condition to impart a desired degree of friction to the drive pulley shaft 70.

柔性環構件可構造成在最高預計的操作負載下呈現相對低的伸長(例如大約3%)，因為張緊構件的任何拉長可被視為對於操作者的輸入延遲或誤差。此外，可將彈簧元件***柔性環構件路徑從而提供恒定的張力並且增加與傳動滑輪64的摩擦。可採用替代的或其它的技術來增加摩擦，例如通過使用在傳動滑輪軸周圍的柔性環構件的多次捲繞。此外，可將V形槽與單個捲繞一起使用或者將螺旋槽與多次捲繞一起使用，從而增強與柔性環構件的接合。 The flexible ring member can be configured to exhibit a relatively low elongation (e.g., about 3%) under the highest expected operational load, as any elongation of the tensioning member can be considered as an input delay or error to the operator. Additionally, the spring element can be inserted into the flexible ring member path to provide a constant tension and increase friction with the drive pulley 64. Alternative or other techniques may be employed to increase friction, such as by using multiple windings of a flexible ring member around the drive pulley shaft. In addition, the V-groove can be used with a single winding or with a helical groove for multiple windings to enhance engagement with the flexible ring member.

如上所述，傳動齒輪62與旋鈕18可以是同軸的並且被固定到旋鈕18，從而這兩個元件一起轉動。類似地，棘輪70也可與旋鈕18是同軸的並且被固定到旋鈕18。在圖 8A的視圖中，將旋鈕18和傳動齒輪62局部地切掉以顯示棘輪70。如果需要，旋鈕18、傳動齒輪62和/或棘輪72可一體地形成。可通過聯接件72將連接桿54固定到第二細長管狀構件16的近端56，以使滑動件20從同軸設置的管狀構件的縱向軸線偏離以避免與滑動件42發生干涉，從而允許它們相對於彼此運動。例如，聯接件72可以是根據需要成形的單個一體化部件，以通過固定的附接而直接地連接到連接桿54和第二細長管狀構件16的近端56，或者通過若干部件進行連接，使得聯接件72以1：1的比率將滑動件20的直線運動直接地轉換成第二細長管狀構件16的直線運動。 As noted above, the drive gear 62 and the knob 18 can be coaxial and secured to the knob 18 such that the two components rotate together. Similarly, the ratchet 70 can also be coaxial with the knob 18 and secured to the knob 18. In the picture In the view of 8A, the knob 18 and the drive gear 62 are partially cut away to show the ratchet 70. The knob 18, the transmission gear 62 and/or the ratchet 72 can be integrally formed if desired. The connecting rod 54 can be secured to the proximal end 56 of the second elongated tubular member 16 by a coupling 72 to deflect the slider 20 from the longitudinal axis of the coaxially disposed tubular member to avoid interference with the slider 42, thereby allowing them to be opposed Exercise with each other. For example, the coupling 72 can be a single, unitary component that is shaped as desired to be directly coupled to the proximal end 56 of the connecting rod 54 and the second elongated tubular member 16 by a fixed attachment, or by a number of components such that The coupling 72 directly converts the linear motion of the slider 20 into a linear motion of the second elongated tubular member 16 at a ratio of 1:1.

參照圖8B，示出了經由被***開口59b中的(構件58a的)凸形突片59a將第三細長管狀構件38的近端58a的附件附著到殼體12的一個替代實施例。近端58a聯接到開槽的管狀構件57，該管狀構件57允許構件16的近端或穿梭件56沿縱向軸線L-L在大體為直線的路徑中平移並且具有很少的或沒有由於滑動件20的致動所造成的連接桿54的彎曲。內管狀構件22的近端60在第二細長管狀構件16的穿梭件56的近側附著到殼體12。 Referring to Figure 8B, an alternate embodiment of attaching the attachment of the proximal end 58a of the third elongate tubular member 38 to the housing 12 via a male tab 59a (of the member 58a) inserted into the opening 59b is illustrated. The proximal end 58a is coupled to a slotted tubular member 57 that allows the proximal end of the member 16 or shuttle 56 to translate in a generally linear path along the longitudinal axis LL with little or no due to the slider 20 The bending of the connecting rod 54 caused by the actuation. The proximal end 60 of the inner tubular member 22 is attached to the housing 12 proximal to the shuttle 56 of the second elongated tubular member 16.

如圖8C中所示，穿梭件56的外表面的一部分被捕獲在開槽構件57的槽57a中，從而確保當穿梭件56由於由槽57a所提供的外部導軌而沿軸線L-L平移時存在很少的或者沒有偏差。而且，穿梭件56設置有貫通開口56a，在貫通開口56a中，構件38(未圖示)充當用於穿梭件56的內部導軌，在圖8D中更詳細示出。 As shown in Figure 8C, a portion of the outer surface of the shuttle 56 is captured in the slot 57a of the slotted member 57 to ensure that the shuttle 56 is present as it translates along the axis LL due to the outer rail provided by the slot 57a. Little or no deviation. Moreover, the shuttle 56 is provided with a through opening 56a in which the member 38 (not shown) acts as an internal guide for the shuttle 56, as shown in more detail in Figure 8D.

圖9中示意性地示出了方向控制組件50的一個實施例的進一步的細節，其中，一個或多個彈性可偏轉元件充當可與棘輪70的齒接合的棘爪。方向控制組件可包括第一彈性可偏轉元件74，該第一彈性可偏轉元件74具有被安裝在殼體12中的一端76和相對的自由端78，該自由端78選擇性地與棘輪70上的齒80接合從而允許逆時針旋轉並且限制順時針旋轉，如所示的。滑動件20包括第一凸輪82，當滑動件20處在相對於殼體12的其最遠側位置時，該第一凸輪82與第一彈性可偏轉元件74接合從而使自由端78與棘輪70接合。正如將會理解的，該構造允許棘輪70在(所示的透視圖中的)逆時針方向上旋轉，因為齒80會使第一彈性可偏轉元件74的自由端78發生偏轉並且允許旋轉。然而，棘輪70在順時針方向上旋轉並不使所接合的自由端78發生偏轉，從而基本上防止棘輪在此方向上的旋轉。由於如上所述使棘輪70聯接到第一細長管狀構件14，所以當滑動件20處在其最遠側位置並且與方向控制組件50接合時第一細長管狀構件14可被拔出但不會前進。 Further details of one embodiment of the directional control assembly 50 are schematically illustrated in FIG. 9, wherein one or more of the resilient deflectable elements act as a pawl that is engageable with the teeth of the ratchet 70. The directional control assembly can include a first resilient deflectable element 74 having an end 76 mounted in the housing 12 and an opposite free end 78 that is selectively coupled to the ratchet 70 The teeth 80 engage to allow counterclockwise rotation and limit clockwise rotation, as shown. The slider 20 includes a first cam 82 that engages the first resiliently deflectable element 74 to bring the free end 78 and the ratchet 70 when the slider 20 is in its most distal position relative to the housing 12. Engage. As will be appreciated, this configuration allows the ratchet 70 to rotate in a counterclockwise direction (in the perspective view shown) because the teeth 80 deflect the free end 78 of the first resilient deflectable element 74 and allow for rotation. However, rotation of the ratchet 70 in a clockwise direction does not deflect the engaged free end 78, thereby substantially preventing rotation of the ratchet in this direction. Since the ratchet 70 is coupled to the first elongate tubular member 14 as described above, the first elongate tubular member 14 can be pulled out but not advanced when the slider 20 is in its most distal position and engaged with the directional control assembly 50 .

方向控制組件50還可包括第二彈性可偏轉元件84，該第二彈性可偏轉元件84具有被安裝在殼體12中的一端86和相對的自由端88，該自由端選擇性地與棘輪70上的齒80接合從而允許順時針旋轉並且限制逆時針旋轉。當滑動件20處在相對於殼體12的其最遠側位置時，滑動件上的第二凸輪90與第二彈性可偏轉元件84接合，從而使自由端88與棘輪70的齒80脫離接合。在所示的構造中，第二彈性 可偏轉元件84被脫離接合，以便第一彈性可偏轉元件74控制棘輪70的旋轉方向，如上所述。然而，當滑動件20向近側運動時，第二凸輪90與第二彈性可偏轉元件84脫離接合，使得自由端88彈回到與齒80接合的其未偏置位置。 The directional control assembly 50 can also include a second resilient deflectable element 84 having an end 86 and an opposite free end 88 mounted in the housing 12, the free end selectively coupled to the ratchet 70 The upper teeth 80 engage to allow clockwise rotation and limit counterclockwise rotation. When the slider 20 is in its most distal position relative to the housing 12, the second cam 90 on the slider engages the second resilient deflectable element 84, thereby disengaging the free end 88 from the teeth 80 of the ratchet 70. . In the configuration shown, the second elasticity The deflectable element 84 is disengaged such that the first resilient deflectable element 74 controls the direction of rotation of the ratchet 70, as described above. However, as the slider 20 moves proximally, the second cam 90 disengages from the second resilient deflectable element 84 such that the free end 88 springs back to its unbiased position engaged with the tooth 80.

類似地，當滑動件20向近側運動時，第一凸輪82也與第一彈性可偏轉元件74脫離接合，從而允許其採取其未偏置位置並且自由端78與齒80脫離接合。因此，滑動件20從其最遠側位置開始的向近側運動允許棘輪70在順時針方向上旋轉，因為齒80會使第二彈性可偏轉元件84的自由端88發生偏轉從而允許順時針旋轉。棘輪70的逆時針旋轉被限制，因為該運動不使接合的自由端88發生偏轉。此外，因為棘輪70聯接到第一細長管狀構件14，所以當使滑動件20從其最遠側位置向近側運動並且與方向控制組件50脫離接合時，可該第一細長管狀構件14可前進但不被拔出。 Similarly, when the slider 20 is moved proximally, the first cam 82 is also disengaged from the first resiliently deflectable element 74, allowing it to assume its unbiased position and the free end 78 disengaged from the tooth 80. Thus, proximal movement of the slider 20 from its most distal position allows the ratchet 70 to rotate in a clockwise direction because the teeth 80 deflect the free end 88 of the second resilient deflectable element 84 to allow for clockwise rotation. . The counterclockwise rotation of the ratchet 70 is limited because this movement does not deflect the engaged free end 88. Moreover, because the ratchet 70 is coupled to the first elongate tubular member 14, the first elongate tubular member 14 can be advanced when the slider 20 is moved proximally from its most distal position and disengaged from the directional control assembly 50. But not pulled out.

圖10和圖11中分別示意性地示出了處於佈置和再約束構造的方向控制組件50的圖示。在圖10中所示的佈置構造中，滑動件20處在相對於殼體12的其最遠側位置，使得第一凸輪82與第一彈性可偏轉元件74接合並且第二凸輪90與第二彈性可偏轉元件84接合。第一凸輪82的接合使第一彈性可偏轉元件74從標稱脫離接合位置偏移到與棘輪70接合，並且第二凸輪90的接合使第二彈性可偏轉元件84從棘輪70的其標稱接合偏移開。因此，第一彈性可偏轉元件74允許棘輪70逆時針轉動並且限制棘輪70順時針轉動。滑動件20還可具有抓爪92，該抓爪92當處在其最遠側位置 時與殼體12的突出部94鎖住。因此，一旦被釋放，需要比使滑動件20直線平移所需的力相對更大的力來使抓爪92發生偏轉。該佈置阻止了滑動件20的意外的直線平移，例如在運輸期間或者使用中的操作期間，並且停留在最遠側位置直到有意地使滑動件20向近側運動。而且，抓爪92和突出部94的相互作用提供正回饋，表明滑動件20已在再約束操作之後返回到其最遠側位置，發出信號表明方向控制組件50已被滑動件20接合並且在支架32的重新定位之後現在可將第一細長管狀構件14拔出。 An illustration of the directional control assembly 50 in an arrangement and re-constrained configuration is shown schematically in Figures 10 and 11, respectively. In the arrangement configuration shown in Figure 10, the slider 20 is in its most distal position relative to the housing 12 such that the first cam 82 engages the first resiliently deflectable element 74 and the second cam 90 and the second The resilient deflectable elements 84 are engaged. Engagement of the first cam 82 biases the first resiliently deflectable element 74 from the nominal disengaged position to engage the ratchet 70, and engagement of the second cam 90 causes the second resiliently deflectable element 84 to assume its nominal position from the ratchet 70 The joint is offset. Thus, the first resilient deflectable element 74 allows the ratchet 70 to rotate counterclockwise and restricts the ratchet 70 from rotating clockwise. The slider 20 can also have a gripper 92 that is at its most distal position It is locked with the projection 94 of the housing 12. Thus, once released, a relatively greater force than the force required to linearly translate the slider 20 is required to deflect the gripper 92. This arrangement prevents unintended linear translation of the slider 20, such as during transport or during use, and stays at the most distal position until the slider 20 is intentionally moved proximally. Moreover, the interaction of the gripper 92 and the projection 94 provides positive feedback indicating that the slider 20 has returned to its most distal position after the reconstraining operation, signaling that the directional control assembly 50 has been engaged by the slider 20 and is in the bracket The first elongated tubular member 14 can now be withdrawn after repositioning of 32.

相應地，圖11中示出了再約束構造，其中，滑動件20已運動到其最遠側位置的近側，如所示的。在此構造中，第一凸輪82與第一彈性可偏轉元件74脫離接合，並且第二凸輪90與第二彈性可偏轉元件84脫離接合。第一彈性可偏轉元件74返回到其未偏置位置並且不與棘輪70接合，並且第二彈性可偏轉元件84返回到其未偏置位置從而與棘輪70接合。因此，第二彈性可偏轉元件84允許棘輪70順時針轉動並且限制棘輪70逆時針轉動。 Accordingly, a re-constrained configuration is illustrated in Figure 11, wherein the slider 20 has been moved to the proximal side of its most distal position, as shown. In this configuration, the first cam 82 is disengaged from the first elastically deflectable element 74 and the second cam 90 is disengaged from the second elastically deflectable element 84. The first resilient deflectable element 74 returns to its unbiased position and does not engage the ratchet 70, and the second resilient deflectable element 84 returns to its unbiased position for engagement with the ratchet 70. Thus, the second resilient deflectable element 84 allows the ratchet 70 to rotate clockwise and restricts the ratchet 70 from rotating counterclockwise.

圖12中示意性地示出了具體實施本公開的技術的替代的脈管內裝置100。與在第二管狀構件外還使用單獨的內管狀構件不同，可將與內管狀構件相關的特徵併入第二管狀構件中。除非另有說明，類似的元件具有對應的附圖標記(例如，脈管內裝置110的殼體112對應於脈管內裝置10的殼體12)。這樣，脈管內裝置100通常可包括殼體112、從殼體112延伸且能夠相對於殼體112做軸向運動的第一細 長管狀構件114以及也從殼體112延伸且能夠相對於殼體114做軸向運動的第二細長管狀構件116。殼體112上的第一致動器構造為旋鈕118並且可使第一細長管狀構件114前進或者拔出第一細長管狀構件114。構造成滑動件120的第二致動器聯接到第二細長管狀構件116，從而滑動件120的運動使第二細長管狀構件116前進並且拔出第二細長管狀構件116。旋鈕118也可具有如上所述的方向控制組件，以根據滑動件120是否與方向控制件接合(即，處在相對於殼體112的其最遠側位置)而限制第一細長管狀構件114所允許的運動方向。在此實施例中，第二細長管狀構件116在其遠端處終止於擴大的錐形頂端124中，並且具有在其近端和遠端之間延伸的腔管126。導絲128可從殼體112向近側延伸穿過與腔管126流體連通的密封的閥130(如魯爾鎖)，並且導絲128也可向遠側延伸超過頂端124。 An alternative intravascular device 100 embodying the techniques of the present disclosure is schematically illustrated in FIG. In contrast to the use of a separate inner tubular member outside of the second tubular member, features associated with the inner tubular member can be incorporated into the second tubular member. Similar elements have corresponding reference numerals unless otherwise indicated (eg, housing 112 of intravascular device 110 corresponds to housing 12 of intravascular device 10). As such, the intravascular device 100 can generally include a housing 112, a first thinner extending from the housing 112 and capable of axial movement relative to the housing 112. The elongated tubular member 114 and the second elongated tubular member 116 also extending from the housing 112 and capable of axial movement relative to the housing 114. The first actuator on the housing 112 is configured as a knob 118 and can advance or pull the first elongated tubular member 114 out of the first elongated tubular member 114. A second actuator configured as a slider 120 is coupled to the second elongated tubular member 116 such that movement of the slider 120 advances the second elongated tubular member 116 and pulls out the second elongated tubular member 116. The knob 118 can also have a directional control assembly as described above to limit the first elongated tubular member 114 depending on whether the slider 120 is engaged with the directional control (ie, at its most distal position relative to the housing 112). Allowable direction of movement. In this embodiment, the second elongate tubular member 116 terminates in its enlarged tapered tip end 124 at its distal end and has a lumen 126 extending between its proximal and distal ends. The guidewire 128 can extend proximally from the housing 112 through a sealed valve 130 (such as a Luer lock) in fluid communication with the lumen 126, and the guidewire 128 can also extend distally beyond the tip end 124.

在不使用導絲的實施例中，第二細長管狀構件116可以是無腔管的實心細長圓柱形構件。可將支架132設置在第一細長管狀構件114的遠端內，用可釋放地固定的環狀鎖134約束於壓握構造中。第二細長管狀構件116的遠端延伸超過環狀鎖134並且具有可與環狀鎖134接合的徑向突出的遠側限位器136。第三細長管狀構件138也可以以固定關係從殼體112延伸，該第三細長管狀構件138具有遠端，該遠端具有直徑，構造成從近側方向與環狀鎖134接合，從而形成近側限位器140。第三細長管狀構件38可具有與殼體112的固定關係，以將近側限位器140保持在對應的固定位 置。殼體112也可包括快速佈置滑動件142，該快速佈置滑動件142操作地連接到第一細長管狀構件114，如上所述。脈管內裝置110可具有抓握器144，也類似於上述實施例。此外，第二細長管狀構件116可具有一個或多個不透射線標誌(如標誌146)，以指示支架132的近側放置、再約束界限或者與用脈管內裝置100所實施的手術相關的其它合適的指示。 In embodiments where a guidewire is not used, the second elongate tubular member 116 can be a solid elongate cylindrical member without a lumen. A bracket 132 can be disposed within the distal end of the first elongate tubular member 114 and constrained in the crimping configuration with a releasably securable annular lock 134. The distal end of the second elongate tubular member 116 extends beyond the annular lock 134 and has a radially projecting distal stop 136 engageable with the annular lock 134. The third elongate tubular member 138 can also extend from the housing 112 in a fixed relationship, the third elongate tubular member 138 having a distal end having a diameter configured to engage the annular lock 134 from a proximal direction to form a proximal portion Side limiter 140. The third elongate tubular member 38 can have a fixed relationship with the housing 112 to retain the proximal stop 140 at a corresponding fixed position Set. The housing 112 can also include a quick-arrangement slider 142 that is operatively coupled to the first elongate tubular member 114, as described above. The intravascular device 110 can have a gripper 144, also similar to the embodiments described above. Moreover, the second elongate tubular member 116 can have one or more radiopaque markers (such as indicia 146) to indicate proximal placement of the stent 132, re-constrained boundaries, or associated with surgery performed with the intravascular device 100. Other suitable indications.

圖13中示意性地示出了類似於圖1的脈管內裝置的本公開的另一個實施例。除非另有說明，類似的元件具有對應的附圖標記(例如，脈管內裝置210的殼體212對應於脈管內裝置10的殼體12)。這樣，脈管內裝置200通常可包括殼體212、從殼體212延伸且能夠相對於殼體212做軸向運動的第一細長管狀構件214以及也從殼體212延伸且能夠相對於殼體214做軸向運動的第二細長管狀構件216。殼體212上的第一致動器構造為旋鈕218並且可使第一細長管狀構件214前進或者拔出第一細長管狀構件214。構造成滑動件220的第二致動器聯接到第二細長管狀構件216，從而滑動件220的運動使第二細長管狀構件216前進和拔出第二細長管狀構件216。旋鈕218也可具有如上所述的方向控制組件，以根據滑動件220是否與方向控制件接合(即，相對於殼體212處於其最遠側位置)而限制第一細長管狀構件214所允許的運動方向。在此實施例中，內管狀構件222從殼體212延伸，並且與殼體212可以是固定關係。內管狀構件222在其遠端處終止於擴大的錐形的頂端224並且具有在其近 端和遠端之間延伸的腔管226。 Another embodiment of the present disclosure similar to the intravascular device of Fig. 1 is schematically illustrated in Fig. 13. Similar elements have corresponding reference numerals unless otherwise indicated (eg, housing 212 of intravascular device 210 corresponds to housing 12 of intravascular device 10). As such, the intravascular device 200 can generally include a housing 212, a first elongated tubular member 214 extending from the housing 212 and capable of axial movement relative to the housing 212, and also extending from the housing 212 and capable of opposing the housing 214 is a second elongated tubular member 216 that moves axially. The first actuator on the housing 212 is configured as a knob 218 and can advance or pull the first elongated tubular member 214 out of the first elongated tubular member 214. A second actuator configured as a slider 220 is coupled to the second elongated tubular member 216 such that movement of the slider 220 advances and pulls the second elongated tubular member 216 out of the second elongated tubular member 216. The knob 218 can also have a directional control assembly as described above to limit the allowable first elongate tubular member 214 depending on whether the slider 220 is engaged with the directional control (ie, at its most distal position relative to the housing 212). Direction of movement. In this embodiment, the inner tubular member 222 extends from the housing 212 and may be in fixed relationship with the housing 212. The inner tubular member 222 terminates at its distal end at the enlarged tapered tip 224 and has a near end thereof A lumen 226 extending between the distal end and the distal end.

導絲228可從殼體212向近側延伸穿過與腔管226流體連通的密封的閥230(如魯爾鎖)，並且導絲228也可向遠側延伸超過頂端224。支架232可被設置在第一細長管狀構件214的遠端內，用可釋放地固定的環狀鎖234約束於壓握構造。第二細長管狀構件216的遠端延伸超過環狀鎖234並且具有可與環狀鎖234接合的徑向突出的遠側限位器236。第三細長管狀構件238也可以以固定關係從殼體212延伸，具有帶近側限位器240的遠端，該近側限位器240具有相對於第三細長管狀構件238增加的直徑以從近側方向與環狀鎖234接合。在此實施例中，近側限位器240可以是附著到第三細長管狀構件238的單獨的元件或者可以是一體的。第三細長管狀構件238可具有與殼體212的固定關係，以將近側限位器240保持在對應的固定位置。 The guidewire 228 can extend proximally from the housing 212 through a sealed valve 230 (such as a Luer lock) in fluid communication with the lumen 226, and the guidewire 228 can also extend distally beyond the tip 224. A bracket 232 can be disposed within the distal end of the first elongate tubular member 214 and constrained to the crimping configuration with a releasably securable annular lock 234. The distal end of the second elongate tubular member 216 extends beyond the annular lock 234 and has a radially projecting distal stop 236 engageable with the annular lock 234. The third elongate tubular member 238 can also extend from the housing 212 in a fixed relationship with a distal end with a proximal stop 240 having an increased diameter relative to the third elongate tubular member 238 to The proximal direction is engaged with the annular lock 234. In this embodiment, the proximal stop 240 can be a separate component attached to the third elongate tubular member 238 or can be integral. The third elongate tubular member 238 can have a fixed relationship with the housing 212 to retain the proximal restraint 240 in a corresponding fixed position.

殼體212也可包括快速佈置滑動件242，該快速佈置滑動件242操作地連接到第一細長管狀構件214，如上所述。脈管內裝置210可具有抓握器244，也類似於上述實施例。此外，第二細長管狀構件216可具有一個或多個不透射線標誌(例如標誌246)，以指示支架232的近側放置、再約束界限或者與用脈管內裝置200所實施的手術有關的其它合適的指示。 The housing 212 can also include a quick deployment slider 242 that is operatively coupled to the first elongated tubular member 214, as described above. The intravascular device 210 can have a gripper 244, also similar to the embodiments described above. Moreover, the second elongate tubular member 216 can have one or more radiopaque markers (eg, indicia 246) to indicate proximal placement of the stent 232, re-constrained boundaries, or related to surgery performed with the intravascular device 200. Other suitable indications.

圖14中示意性地示出了本公開的又一個實施例，其也類似於圖1的脈管內裝置，並且類似的元件具有對應的附圖標記(例如，脈管內裝置310的殼體312對應於脈管 內裝置10的殼體12)，除非另有說明。這裡，脈管內裝置300通常可包括殼體312、從殼體312延伸且能夠相對於殼體312做軸向運動的第一細長管狀構件314以及也從殼體312延伸且能夠相對於殼體314做軸向運動的第二細長管狀構件316。構造為旋鈕318的殼體312上的第一致動器可使第一細長管狀構件314前進或者將第一細長管狀構件314拔出。構造成滑動件320的第二致動器聯接到第二細長管狀構件316，從而滑動件320的運動使第二細長管狀構件316前進和將其拔出。旋鈕318也可具有如上所述的方向控制組件，以根據滑動件320是否與方向控制件接合(即，處在相對於殼體312的其最遠側位置)而限制第一細長管狀構件314所允許的運動方向。在此實施例中，內管狀構件322從殼體312延伸，並且與殼體312可以是固定關係。內管狀構件322在其遠端處終止於擴大的錐形頂端324並且具有在其近端和遠端之間延伸的腔管326。 Yet another embodiment of the present disclosure is schematically illustrated in FIG. 14, which is also similar to the intravascular device of FIG. 1, and like elements have corresponding reference numerals (eg, housings of intravascular device 310). 312 corresponds to the vessel The housing 12) of the inner device 10, unless otherwise stated. Here, the intravascular device 300 can generally include a housing 312, a first elongate tubular member 314 extending from the housing 312 and capable of axial movement relative to the housing 312, and also extending from the housing 312 and capable of being opposite the housing 314 is a second elongated tubular member 316 that moves axially. A first actuator on the housing 312 configured as a knob 318 can advance the first elongated tubular member 314 or pull the first elongated tubular member 314 out. A second actuator configured as a slider 320 is coupled to the second elongated tubular member 316 such that movement of the slider 320 advances and pulls the second elongated tubular member 316 out. The knob 318 can also have a directional control assembly as described above to limit the first elongate tubular member 314 depending on whether the slider 320 is engaged with the directional control (i.e., at its most distal position relative to the housing 312). Allowable direction of movement. In this embodiment, the inner tubular member 322 extends from the housing 312 and may be in fixed relationship with the housing 312. The inner tubular member 322 terminates at its distal end at the enlarged tapered tip end 324 and has a lumen 326 extending between its proximal and distal ends.

導絲328可從殼體312向近側延伸穿過與腔管326流體連通的密封的閥330(如魯爾鎖)，並且導絲328也可向遠側延伸超過頂端324。可將支架332設置在第一細長管狀構件314的遠端內，用可釋放地固定的環狀鎖334約束於壓握形狀中。第二細長管狀構件316的遠端延伸超過環狀鎖334，並且具有可與環狀鎖334接合的徑向突出的遠側限位器336。第三細長管狀構件338也可以以固定關係從殼體312延伸，具有遠端，遠端具有增加直徑的近側限位器340以從近側方向與環狀鎖334接合。第三細長管狀構件338可具有 與殼體312的固定關係，以將近側限位器340保持在對應的固定位置。 The guidewire 328 can extend proximally from the housing 312 through a sealed valve 330 (such as a Luer lock) in fluid communication with the lumen 326, and the guidewire 328 can also extend distally beyond the tip 324. A bracket 332 can be disposed within the distal end of the first elongate tubular member 314 and constrained in the crimped shape with a releasably securable annular lock 334. The distal end of the second elongate tubular member 316 extends beyond the annular lock 334 and has a radially projecting distal stop 336 engageable with the annular lock 334. The third elongate tubular member 338 can also extend from the housing 312 in a fixed relationship with a distal end having an increased diameter proximal stop 340 to engage the annular lock 334 from a proximal direction. The third elongated tubular member 338 can have A fixed relationship with the housing 312 to maintain the proximal stop 340 in a corresponding fixed position.

如所示的，在此實施例中，環狀鎖334可以是自由浮動的並且具有近側部分，該近側部分的尺寸被設置成配合在第三細長管狀構件338的內直徑中。在一個方面，環狀鎖334的近側部分可具有足夠的距離，從而當支架332經歷最大量的縮短時環狀鎖334的一些量仍然留在第三細長管狀構件338的內直徑中，從而保持環狀鎖334和第三細長管狀構件338之間的關係。環狀鎖334可具有中間部分，該中間部分具有增大的直徑，其可被近側限位器340接合。環狀鎖334的遠側部分可具有足夠的直徑，以當支架被壓握時與支架332接合從而將支架固定。環狀鎖334可以是整體的或者可以由如所期望的許多單獨的元件形成。殼體312也可包括快速佈置滑動件342，該快速佈置滑動件342操作地連接到第一細長管狀構件314，如上所述。脈管內裝置310可具有抓握器344，也類似於上述實施例。此外，第二細長管狀構件316可具有一個或多個不透射線標誌(如標誌346)，以指示支架332的近側放置、再約束界限或者與用脈管內裝置300所實施的手術有關的其它合適的指示。 As shown, in this embodiment, the annular lock 334 can be free-floating and have a proximal portion that is sized to fit within the inner diameter of the third elongate tubular member 338. In one aspect, the proximal portion of the annular lock 334 can have a sufficient distance such that some amount of the annular lock 334 remains in the inner diameter of the third elongate tubular member 338 when the stent 332 undergoes the greatest amount of shortening, thereby The relationship between the annular lock 334 and the third elongated tubular member 338 is maintained. The annular lock 334 can have an intermediate portion with an increased diameter that can be engaged by the proximal stop 340. The distal portion of the annular lock 334 can have a sufficient diameter to engage the bracket 332 to secure the bracket when the bracket is crimped. The annular lock 334 can be unitary or can be formed from a number of separate components as desired. The housing 312 can also include a quick-arrangement slider 342 that is operatively coupled to the first elongate tubular member 314, as described above. The intravascular device 310 can have a gripper 344, also similar to the embodiments described above. Moreover, the second elongate tubular member 316 can have one or more radiopaque markers (such as indicia 346) to indicate proximal placement of the stent 332, re-constrained boundaries, or related to surgery performed with the intravascular device 300. Other suitable indications.

在所示的實施例中，殼體312可包括位於與快速佈置滑動件342的行進範圍相鄰的合適位置的再約束界限標誌350。這表示仍然將會使支架332能夠被可靠地再約束的第一細長管狀構件314的最遠的收回。再約束界限標誌350可作為位於脈管內裝置300的遠端的合適的不透射線標 誌(例如346)的替代或補充而提供。殼體312也可具有可去除蓋352，以保護滑動件320並且幫助防止在支架佈置期間的意外操作。如果期望將支架332重新定位，在開始再約束過程之前操作者首先去除蓋352以通達滑動件320。 In the illustrated embodiment, the housing 312 can include a re-constrained boundary marker 350 located at a suitable location adjacent the range of travel of the quick-disposed slider 342. This represents the farthest retraction of the first elongate tubular member 314 that will still enable the bracket 332 to be reliably re-constrained. The re-constrained boundary marker 350 can serve as a suitable radiopaque marker at the distal end of the intravascular device 300 Provided by an alternative or supplement to Zhi (eg, 346). The housing 312 can also have a removable cover 352 to protect the slider 320 and help prevent accidental operation during stent placement. If it is desired to reposition the bracket 332, the operator first removes the cover 352 to access the slider 320 before beginning the re-constraining process.

在用脈管內裝置實施手術之前，可執行沖洗步驟以將空氣從系統中排出從而使在手術期間可能引入的空氣的量最小化。為了有助於該沖洗步驟，本公開的設計允許經過單個埠進行沖洗。如圖14中所示，內管狀構件322的遠側部分可具有與腔管326流體連通的多個孔眼。在使脈管內裝置310在導絲328上前進之前，可將沖洗流體(如生理鹽水)的源連接到閥330以將該流體輸送到腔管326的近端中。當腔管被填充時，系統中的空氣將會被排出直到流體流出孔眼354並且流過第一細長管狀構件314、支架332和內管狀構件322之間的任何空隙。操作者可暫時地阻塞腔管326的遠側開口以迫使流體流過孔眼354。此外，如圖15的端視圖中示意性地示出，錐形的遠側頂端324的外直徑可緊密地對應於第一細長管狀構件314的內直徑，使得在沖洗步驟期間多個凹槽356有助於流體和空氣的流出。 Prior to performing the procedure with the intravascular device, a rinsing step can be performed to expel air from the system to minimize the amount of air that may be introduced during the procedure. To facilitate this rinsing step, the design of the present disclosure allows for rinsing through a single crucible. As shown in FIG. 14, the distal portion of the inner tubular member 322 can have a plurality of apertures in fluid communication with the lumen 326. Prior to advancing the intravascular device 310 on the guidewire 328, a source of irrigation fluid (e.g., saline) can be coupled to the valve 330 to deliver the fluid into the proximal end of the lumen 326. When the lumen is filled, air in the system will be expelled until fluid exits aperture 354 and flows through any gap between first elongate tubular member 314, stent 332, and inner tubular member 322. The operator can temporarily block the distal opening of the lumen 326 to force fluid flow through the aperture 354. Moreover, as shown schematically in the end view of Figure 15, the outer diameter of the tapered distal tip 324 can closely correspond to the inner diameter of the first elongate tubular member 314 such that the plurality of grooves 356 during the rinsing step Helps the flow of fluids and air.

如上所討論的，可以利用具體實施了本公開的技術的脈管內輸送系統來佈置的支架可以是自擴張的。圖16的側視圖中示意性地示出了處於壓握構造的支架32的一個例子，其採用完全連接的螺旋狀幾何結構，具有當支架被壓握時的長度L_c和當支架被壓握時的外直徑D_c。例如，當被設置在第一細長管狀構件14的遠側部分中時，圖16中所 示的構造對應於完全受約束狀態。如圖中所示，合適的特徵(例如眼孔等)可與環狀鎖34上的對應凹陷相互作用以在一個操作狀態中固定支架32並且在另一個操作狀態中釋放支架32。當把第一細長管狀構件14完全地拔出來佈置支架32時，其可根據脈管的幾何形狀在患者脈管內擴張，直到最大非受約束長度L_nc和直徑D_nc，根據圖17的側視圖中示意性地示出的其設計參數。當擴張時，支架32的特徵被從環狀鎖34釋放，從而將其釋放。壓握長度與標稱佈置長度之間的差當大於10%時被認為是明顯的。當被佈置時，在支架擴張時如果支架的遠端與脈管壁接觸，則其可相對於脈管不動。因此，當佈置支架時，支架的近端可向遠側運動以允許支架擴張。 As discussed above, the stent that can be deployed using an intravascular delivery system that specifically implements the techniques of the present disclosure can be self-expanding. 16 is a side view schematically illustrating an example of a crimped configuration in the holder 32, which employs a spiral geometry fully connected, has a length L _c when the stent is crimped when the stent is crimped and when The outer diameter D _c . For example, when disposed in the distal portion of the first elongate tubular member 14, the configuration shown in Figure 16 corresponds to a fully constrained state. As shown in the figures, suitable features (e.g., eyelets, etc.) can interact with corresponding depressions on the annular lock 34 to secure the stent 32 in one operational state and to release the stent 32 in another operational state. When the first elongate tubular member 14 is fully pulled out to position the stent 32, it can be expanded within the patient's vessel according to the geometry of the vessel until the maximum unconstrained length _Lnc and diameter _Dnc , according to FIG. Its design parameters are shown schematically in side view. When expanded, the features of the bracket 32 are released from the ring lock 34 to release it. The difference between the grip length and the nominal arrangement length is considered to be significant when it is greater than 10%. When deployed, the distal end of the stent can be immovable relative to the vessel if the distal end of the stent is in contact with the vessel wall when the stent is expanded. Thus, when the stent is placed, the proximal end of the stent can be moved distally to allow the stent to expand.

正如將會理解的，可將任何合適的設計應用於與本公開脈管內裝置一起使用的環狀鎖。該環狀鎖可與處在其壓握直徑的支架相互作用，使得在將支架被壓握在外護套中時，支架與環狀鎖一起運動或者以固定關係保持一起不動。支架鎖可以軸向地短於支架。通常，支架鎖可與壓握支架的相對短的長度(高至4或5mm)相互作用。當支架不在允許與支架鎖聯繫的減小的直徑中彈性變形(受約束)並且溫度超過轉變溫度時，支架自擴張到其”記憶的”形狀，並且不再與支架鎖相互作用並且被釋放。支架鎖可構造成與第三細長管狀構件或近側限位器發生機械相互作用，以阻止支架和環狀鎖組件在近側方向上的運動。 As will be appreciated, any suitable design can be applied to the annular lock for use with the intravascular device of the present disclosure. The ring lock can interact with a bracket at its crimping diameter such that when the bracket is crimped into the outer sheath, the bracket moves with the ring lock or remains stationary in a fixed relationship. The bracket lock can be axially shorter than the bracket. Typically, the bracket lock can interact with a relatively short length (up to 4 or 5 mm) of the crimp holder. When the stent is not elastically deformed (constrained) in a reduced diameter that allows for engagement with the stent lock and the temperature exceeds the transition temperature, the stent self-expands to its "memorized" shape and no longer interacts with the stent lock and is released. The stent lock can be configured to mechanically interact with the third elongate tubular member or proximal stop to prevent movement of the stent and the annular lock assembly in a proximal direction.

類似地，支架鎖可構造成與遠側限位器發生機械 相互作用，以阻止支架和環狀鎖組件的向遠側運動。環狀鎖的至少一部分可由剛性材料形成，在把設計的轉矩和軸向力施加到該材料時其保持大體圓柱形狀。環狀鎖的一些實施例被動地徑向地釋放支架(即，支架不被環狀鎖約束於減小的直徑)。支架鎖的一些實施例主動地徑向地釋放支架(即，沒有致動，支架鎖也將支架的一部分約束於減小的直徑)。在一些實施例中，可通過支架的結構元件實現支架和環狀鎖之間的聯繫。例如，支架撐桿可徑向地向內延伸達一定距離，並且可與順應在撐桿或其它結構構件周圍的環狀鎖的可變形材料接觸，以在一個操作狀態中固定支架並且在另一操作狀態中釋放支架。在輸送系統的一些實施例中，環狀鎖能夠自由地軸向平移並且繞管狀構件(例如第二細長管狀構件16)的縱向軸線旋轉，環狀鎖被承載在該管狀構件上。 Similarly, the bracket lock can be configured to mechanically interact with the distal stop Interaction to prevent distal movement of the stent and ring lock assembly. At least a portion of the annular lock may be formed from a rigid material that maintains a generally cylindrical shape when the designed torque and axial forces are applied to the material. Some embodiments of the annular lock passively release the bracket radially (ie, the bracket is not constrained to a reduced diameter by the annular lock). Some embodiments of the bracket lock actively release the bracket radially (ie, without actuation, the bracket lock also constrains a portion of the bracket to a reduced diameter). In some embodiments, the connection between the stent and the annular lock can be achieved by the structural elements of the stent. For example, the bracket struts may extend radially inwardly for a distance and may be in contact with a deformable material that conforms to an annular lock around the struts or other structural members to secure the bracket in one operational state and in another Release the stand during operation. In some embodiments of the delivery system, the annular lock is free to translate axially and rotate about a longitudinal axis of the tubular member (eg, the second elongated tubular member 16) on which the annular lock is carried.

在輸送系統的一些實施例中，近側限位器和遠側限位器之間的長度可以是可變的並且由操作者決定，但最初在準備好使用時，當整個支架被徑向地受約束在外構件中時，環狀鎖的可能的軸向行進距離可以大於支架長度的百分之二十(20)以適應縮短，並且在其它實施例中大於該長度的百分之二十五(25)。在一些實施例中，環狀鎖在兩個限位器之間的可能的軸向行進距離是可變的並且由操作者決定，但最初在準備好使用時可大於對應於最大預期縮短的預定長度。 In some embodiments of the delivery system, the length between the proximal stop and the distal stop can be variable and determined by the operator, but initially when ready for use, when the entire stent is radially When constrained in the outer member, the possible axial travel distance of the annular lock may be greater than twenty percent (20) of the length of the stent to accommodate shortening, and in other embodiments greater than twenty-five percent of the length. (25). In some embodiments, the possible axial travel distance of the ring lock between the two stops is variable and determined by the operator, but may initially be greater than the predetermined maximum shortened schedule when ready for use. length.

已參考本發明的當前公開的實施例給出了前面 的描述。本發明所屬領域的技術人員將會理解的是，可在不實質性地背離本發明的原理、精神和範圍的情況下實施所描述的結構中的變更和變化。如本領域技術人員所理解的，附圖不一定按比例繪製。因此，前面的描述不應被理解成只屬於在附圖中所描述和示出的確切結構，而是應被理解成與所附申請專利範圍一致並且支持所附申請專利範圍，所附申請專利範圍應當具有它們最全面和合理的範圍。 The foregoing has been given with reference to the presently disclosed embodiments of the present invention description of. Variations and modifications of the described structures may be practiced without departing from the spirit and scope of the invention. The drawings are not necessarily to scale unless the Therefore, the foregoing description is not to be construed as being limited to The scope should have their most comprehensive and reasonable scope.

10‧‧‧脈管內裝置 10‧‧‧Intravascular device

12‧‧‧殼體 12‧‧‧ housing

14‧‧‧第一細長管狀構件 14‧‧‧First elongated tubular member

16‧‧‧第二細長管狀構件 16‧‧‧Second elongated tubular member

18‧‧‧旋鈕 18‧‧‧ knob

20、42‧‧‧滑動件 20, 42‧‧‧Sliding parts

22‧‧‧內管狀構件 22‧‧‧Inner tubular member

24‧‧‧頂端 24‧‧‧Top

26‧‧‧腔管 26‧‧‧ lumen

28‧‧‧導絲 28‧‧‧ Guide wire

30‧‧‧閥 30‧‧‧ valve

32‧‧‧支架 32‧‧‧ bracket

34‧‧‧環狀鎖 34‧‧‧Annual lock

36‧‧‧遠側限位器 36‧‧‧ distal limiter

38‧‧‧第三細長管狀構件 38‧‧‧ Third elongated tubular member

40‧‧‧近側限位器 40‧‧‧ proximal stop

44‧‧‧抓握器 44‧‧‧gripper

46‧‧‧標誌 46‧‧‧ sign

48‧‧‧脈管壁 48‧‧‧Vascular wall

L-L‧‧‧縱向軸線 L-L‧‧‧ longitudinal axis

Claims (16)

一種用於佈置和再約束可擴張腔內裝置的脈管內裝置，包括：殼體；從所述殼體延伸且能夠相對於所述殼體做軸向運動的第一細長管狀構件；從所述殼體延伸且能夠相對於所述殼體做軸向運動的第二細長管狀構件，所述第二細長管狀構件具有遠端，所述遠端帶有徑向突出的遠側限位器，其中，所述第二細長管狀構件被同軸地設置在所述第一細長管狀構件內；環狀鎖，所述環狀鎖構造成在一個操作狀態中固定且在另一個操作狀態中釋放所述腔內裝置，其中，所述環狀鎖被同軸地設置在所述第二細長管狀構件上並且被同軸地設置在所述第一管狀構件內，並且其中，所述環狀鎖具有小於所述遠側限位器的有效外直徑的內直徑；在所述殼體上的旋鈕，所述旋鈕被柔性環構件聯接到所述第一細長管狀構件，使得所述旋鈕的操縱使所述第一細長管狀構件相對於所述殼體軸向地運動；以及在所述殼體上的滑動件，所述滑動件聯接到所述柔性環構件。 An intravascular device for arranging and reconstraining an expandable intraluminal device, comprising: a housing; a first elongate tubular member extending from the housing and axially movable relative to the housing; a second elongated tubular member extending from the housing and axially movable relative to the housing, the second elongated tubular member having a distal end with a radially protruding distal stop, Wherein the second elongate tubular member is coaxially disposed within the first elongate tubular member; an annular lock configured to be secured in one operational state and to release the release in another operational state An intraluminal device, wherein the annular lock is coaxially disposed on the second elongate tubular member and disposed coaxially within the first tubular member, and wherein the annular lock has less than the An inner diameter of an effective outer diameter of the distal limiter; a knob on the housing, the knob being coupled to the first elongated tubular member by a flexible ring member such that manipulation of the knob causes the first Elongated tubular member relative to Axially moving said housing; and a sliding member on said housing, said slide member coupled to the flexible ring member. 如請求項1所述的脈管內裝置，其中，所述旋鈕提供機 械利益，使得所述第一細長管狀構件相對於所述殼體的對應軸向運動小於輸入運動。 The intravascular device according to claim 1, wherein the knob providing device The mechanical advantage is that the corresponding axial movement of the first elongate tubular member relative to the housing is less than the input motion. 如請求項1所述的脈管內裝置，其中，所述環狀鎖包括多個凹陷，所述多個凹陷構造成捕獲所述可擴張腔內裝置的元件。 The intravascular device of claim 1, wherein the annular lock comprises a plurality of depressions configured to capture elements of the expandable intraluminal device. 如請求項1所述的脈管內裝置，還包括在所述殼體的遠側被同軸地設置在所述第一細長管狀構件上的摩擦致動器。 The intravascular device of claim 1, further comprising a friction actuator coaxially disposed on the first elongate tubular member distal to the housing. 如請求項1所述的脈管內裝置，還包括被同軸地設置在所述第二細長管狀構件內且從所述殼體延伸經過所述遠側限位器的內細長管狀構件，其中，所述內細長管狀構件包括腔管、與所述腔管流體連通的近側埠以及具有與所述腔管流體連通的多個孔眼的遠側部分。 The intravascular device of claim 1, further comprising an inner elongated tubular member coaxially disposed within the second elongated tubular member and extending from the housing through the distal limiter, wherein The inner elongated tubular member includes a lumen, a proximal bore in fluid communication with the lumen, and a distal portion having a plurality of apertures in fluid communication with the lumen. 如請求項5所述的脈管內裝置，其中，所述脈管內裝置包括錐形的遠側頂端，所述遠側頂端具有多個凹槽，所述多個凹槽構造成當所述遠側頂端鄰接所述第一細長管狀構件的遠端時允許從所述內細長管狀構件的孔眼中供應的流體的流出。 The intravascular device of claim 5, wherein the intravascular device comprises a tapered distal tip, the distal tip having a plurality of grooves configured to be The distal tip abuts the distal end of the first elongate tubular member to allow for the outflow of fluid supplied from the bore of the inner elongate tubular member. 一種可再約束支架輸送系統，包括：殼體；從所述殼體延伸且能夠相對於所述殼體做軸向運動的第一細長管狀構件；從所述殼體延伸且能夠相對於所述殼體做軸向運動的第二細長管狀構件，所述第二細長管狀構件具有遠 端，所述遠端帶有徑向突出的遠側限位器，其中，所述第二細長管狀構件被同軸地設置在所述第一細長管狀構件內；環狀鎖，所述環狀鎖被同軸地設置在所述第二細長管狀構件上且被同軸地設置在所述第一管狀構件內，其中，所述環狀鎖具有小於所述遠側限位器的有效外直徑的內直徑；自擴張支架，所述自擴張支架被可釋放地固定到所述環狀鎖；在所述殼體上的旋鈕，所述旋鈕被柔性環構件聯接到所述第一細長管狀構件，使得所述旋鈕的操縱使所述第一細長管狀構件相對於所述殼體軸向地運動；以及在所述殼體上的滑動件，所述滑動件聯接到所述柔性環構件。 A reconstrainable stent delivery system comprising: a housing; a first elongate tubular member extending from the housing and axially moveable relative to the housing; extending from the housing and capable of being opposite the a second elongated tubular member that is axially moved by the housing, the second elongated tubular member having a distal The distal end has a radially protruding distal stop, wherein the second elongated tubular member is coaxially disposed within the first elongated tubular member; an annular lock, the annular lock Coaxially disposed on the second elongate tubular member and coaxially disposed within the first tubular member, wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop a self-expanding stent releasably secured to the annular lock; a knob on the housing, the knob being coupled to the first elongated tubular member by a flexible ring member such that Manipulation of the knob causes the first elongate tubular member to move axially relative to the housing; and a slider on the housing that is coupled to the flexible ring member. 一種用於佈置和再約束可擴張腔內裝置的方法，包括：提供脈管內裝置，所述脈管內裝置具有殼體、從所述殼體延伸且能夠相對於所述殼體做軸向運動的第一細長管狀構件、從所述殼體延伸且能夠相對於所述殼體做軸向運動的第二細長管狀構件、環狀鎖、在所述殼體上的旋鈕以及在所述殼體上的滑動件，所述第二細長管狀構件具有遠端，所述遠端帶有徑向突出的遠側限位器，其中，所述第二細長管狀構件被同軸地設置在所述第一細長管狀構件內，所述環狀鎖可釋放地固定可擴張腔內裝置，其中，所述環狀鎖被同軸地設置在所述第二 細長管狀構件上並且被同軸地設置在所述第一管狀構件內，並且其中，所述環狀鎖具有小於所述遠側限位器的有效外直徑的內直徑，所述旋鈕被柔性環構件聯接到所述第一細長管狀構件，所述滑動件聯接到所述柔性環構件；將所述脈管內裝置的遠端定位在患者的脈管系統內的期望位置；以及操縱所述旋鈕以使所述第一細長管狀構件相對於所述殼體軸向地運動，使得所述可擴張腔內裝置的一部分被暴露。 A method for arranging and reconstraining an expandable intraluminal device, comprising: providing an intravascular device having a housing extending from the housing and capable of axially relative to the housing a first elongated tubular member of movement, a second elongated tubular member extending from the housing and axially movable relative to the housing, an annular lock, a knob on the housing, and the housing a sliding member on the body, the second elongated tubular member having a distal end, the distal end having a radially protruding distal stop, wherein the second elongated tubular member is coaxially disposed at the first In an elongated tubular member, the annular lock releasably secures the expandable intraluminal device, wherein the annular lock is coaxially disposed in the second An elongate tubular member and disposed coaxially within the first tubular member, and wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop, the knob being a flexible ring member Coupled to the first elongate tubular member, the slider coupled to the flexible ring member; positioning a distal end of the intravascular device at a desired location within a patient's vasculature; and manipulating the knob to The first elongate tubular member is moved axially relative to the housing such that a portion of the expandable intraluminal device is exposed. 如請求項8所述的方法，還包括操縱聯接到所述柔性環構件的在所述殼體上的滑動件，以使所述第一細長管狀構件相對於所述殼體向近側軸向地運動。 The method of claim 8 further comprising manipulating a slider coupled to the housing of the flexible ring member such that the first elongated tubular member is proximally axially relative to the housing Ground movement. 如請求項8所述的方法，還包括操縱聯接到所述第二細長管狀構件的在所述殼體上的第二致動器以使所述第二細長管狀構件相對於所述殼體向近側軸向地運動直到所述遠側限位器與所述環狀鎖接合。 The method of claim 8 further comprising manipulating a second actuator coupled to the second elongate tubular member on the housing to cause the second elongate tubular member to be oriented relative to the housing The proximal side moves axially until the distal stop engages the annular lock. 如請求項10所述的方法，還包括使所述第一細長管狀構件相對於所述殼體向遠側軸向地運動以再約束所述可擴張腔內裝置。 The method of claim 10, further comprising moving the first elongate tubular member axially relative to the housing to re-constrain the expandable intraluminal device. 如請求項11所述的方法，還包括在使所述第一細長管狀構件向遠側軸向地運動的同時將力施加到所述第二致動器，以保持所述遠側限位器與所述環狀鎖接合。 The method of claim 11 further comprising applying a force to the second actuator while axially moving the first elongate tubular member to retain the distal stop Engaged with the annular lock. 如請求項12所述的方法，還包括通過去除設置在所述第 二致動器上的蓋而通達所述第二致動器，從而當去除所述蓋時所述第二致動器是可見的。 The method of claim 12, further comprising setting the The cover on the two actuators passes to the second actuator such that the second actuator is visible when the cover is removed. 如請求項11所述的方法，還包括當使所述第一細長管狀構件相對於所述殼體向遠側軸向地運動時，操縱在所述殼體的遠側被同軸地設置在所述第一細長管狀構件上的摩擦致動器。 The method of claim 11 further comprising, when the first elongate tubular member is axially moved distally relative to the housing, the manipulation is coaxially disposed at a distal side of the housing A friction actuator on the first elongate tubular member. 如請求項8所述的方法，其中，所述脈管內裝置還包括：被同軸地設置在所述第二細長管狀構件內且從所述殼體中延伸經過所述遠側限位器的內細長管狀構件，其中，所述內細長管狀構件包括腔管、與所述腔管流體連通的近側埠以及具有與所述腔管流體連通的多個孔眼的遠側部分，還包括在將所述脈管內裝置的遠端定位在期望位置之前將沖洗流體供應到所述近側埠，以導致所述沖洗流體從所述多個孔眼流動。 The method of claim 8, wherein the intravascular device further comprises: coaxially disposed within the second elongated tubular member and extending from the housing through the distal stop An inner elongate tubular member, wherein the inner elongate tubular member comprises a lumen, a proximal condyx in fluid communication with the lumen, and a distal portion having a plurality of perforations in fluid communication with the lumen, further comprising The distal end of the intravascular device is positioned to supply irrigation fluid to the proximal fistula prior to positioning at a desired location to cause the irrigation fluid to flow from the plurality of orifices. 如請求項15所述的方法，其中，所述脈管內裝置包括具有多個凹槽的錐形的遠側頂端，並且其中，將沖洗流體供應到所述近側埠導致所述沖洗流體被傳送通過所述第三細長管狀構件的所述孔眼並且當所述遠側頂端鄰接所述第一細長管狀構件的遠端時從所述凹槽流出。 The method of claim 15, wherein the intravascular device comprises a tapered distal tip having a plurality of grooves, and wherein supplying irrigation fluid to the proximal fistula causes the irrigation fluid to be Passing through the aperture of the third elongate tubular member and flowing out of the recess when the distal tip abuts the distal end of the first elongate tubular member.