TW202120041A - Stent delivery with expansion assisting delivery wire - Google Patents
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本發明大致關於用於脈管系統中缺陷之治療的介入性治療處理或血管手術的裝置,且更具體地關於將支架輸送到患者體腔中的治療部位及在該治療部位處打開支架。 The present invention generally relates to devices for interventional treatment or vascular surgery for the treatment of defects in the vasculature, and more specifically to the delivery of a stent to a treatment site in a patient's body cavity and the opening of the stent at the treatment site.
支架係插入血管中以提供血管內的開放路徑,且其等已廣泛用於閉塞血管的血管內血管成形術(intravascular angioplasty)治療及其他應用。支架可係自擴張的,或者可藉由從支架內施加的徑向力來擴張,例如當支架配有球囊時。 Stents are inserted into blood vessels to provide an open path within the blood vessels, and they have been widely used in intravascular angioplasty treatment and other applications to occlude blood vessels. The stent may be self-expanding, or it may be expanded by radial force applied from within the stent, for example when the stent is equipped with a balloon.
編織支架可藉由以平織技術編織在一起的金屬絲的管特徵化。在輸送到治療部位期間,編織支架可以細長的塌縮構形行進通過具有小直徑的導管,且編織支架可在治療部位處擴大直徑。以編織支架的適當治療可要求支架徑向延伸到支架植入於其中的體腔壁。雖然編織支架可係自擴張的,但此類植入物一般以低開啟力打開,並因此可能無法完全打開以適形於血管壁。在部署後,諸如引導線、導管、球囊等的輔助裝置可用以跨編織物並試圖進一步擴張編織支架以改善血管壁的適形度。常發生諸如非刻意的編織物移動或無法完 全打開編織物的問題。此外,不能回收與輸送線分離的編織植入物以用於重新定位。 Braided stents can be characterized by tubes of metal wires woven together in a plain weave technique. During delivery to the treatment site, the braided stent can travel through a catheter having a small diameter in an elongated collapsed configuration, and the braided stent can expand in diameter at the treatment site. Proper treatment with braided stents may require the stent to extend radially to the wall of the body cavity in which the stent is implanted. Although braided stents can be self-expanding, such implants generally open with a low opening force, and therefore may not be fully opened to conform to the vessel wall. After deployment, auxiliary devices such as guide wires, catheters, balloons, etc. can be used to span the braid and attempt to further expand the braided stent to improve the conformity of the vessel wall. Such as unintentional movement of the braid or incompleteness Fully open the problem of the braid. In addition, the braided implant separated from the delivery line cannot be recovered for repositioning.
本發明的一目的是提供用於改善一編織支架的血管壁適形度的系統、裝置、及方法。大致上,一種可擴張元件,其在一遠端處具有一遠側錨定部件、在近端處具有一近側錨定部件、及一編織中間部分,該可擴張元件可係藉由一輸送線通過一導管輸送到一治療部位,該輸送線具有:一第一遠側凸起,該第一遠側凸起可係朝遠側平移以朝遠側推動該遠側錨定件及在離開該導管之一遠端時釋放該遠側錨定件;一成形區段,該成形區段可係移動以從該編織中間部分內施加一徑向力以擴張該編織中間部分;及一第二近側凸起,該第二近側凸起可係朝遠側平移以朝遠側推動該近側錨定件及將該可擴張元件從該導管排出。 An object of the present invention is to provide a system, device, and method for improving the conformity of the vascular wall of a braided stent. Generally, an expandable element has a distal anchoring part at a distal end, a proximal anchoring part at a proximal end, and a braided middle part. The expandable element can be delivered by a delivery The wire is delivered to a treatment site through a catheter. The delivery wire has: a first distal protrusion, which can be translated distally to push the distal anchor member distally and when leaving Releasing the distal anchor when a distal end of the catheter; a shaped section that can be moved to apply a radial force from within the braided middle part to expand the braided middle part; and a second A proximal protrusion, the second proximal protrusion can be translated distally to push the proximal anchor member distally and expel the expandable element from the catheter.
該輸送線亦可具有經定位在該遠側凸起之近側及該近側凸起之遠側的一第三取回凸起,該第三取回凸起可朝近側平移以朝近側推動該近側錨定件。具有從該導管排出並從該輸送線釋放的一遠側部分及定位在該導管內的一近側錨定件的部分植入的一可擴張元件可藉由朝近側平移該輸送線以朝近側推動該近側錨定件而回縮,從而將該編織部分及遠側錨定件朝近側拉動至該導管中。 The delivery line may also have a third retrieving protrusion positioned at the proximal side of the distal protrusion and the distal side of the proximal protrusion, and the third retrieving protrusion can be translated toward the proximal side to move toward the proximal side. Push the proximal anchor laterally. A partially implanted expandable element having a distal portion discharged from the catheter and released from the delivery line and a proximal anchor positioned in the catheter can be moved toward the delivery line by translating the delivery line proximally The proximal anchor is pushed proximally to retract, thereby pulling the braided part and the distal anchor proximally into the catheter.
實例血管治療設備可包括一導管、一可擴張元件、及一輸送線。該導管可具有一內腔,該可擴張元件可係藉由該輸送線輸送通過該內腔至一治療部位。該可擴張元件可具有:一近端;一遠端;一編織部分,其位於該 近端及該遠端之間;一近側錨定部件,其設置在該近端處;及一遠側錨定部件,其設置在該遠端處。 An example vascular treatment device may include a catheter, an expandable element, and a delivery line. The catheter can have a lumen, and the expandable element can be delivered through the lumen to a treatment site by the delivery line. The expandable element may have: a proximal end; a distal end; a braided part, which is located at the Between the proximal end and the distal end; a proximal anchoring component disposed at the proximal end; and a distal anchoring component disposed at the distal end.
該可擴張元件可具有經定尺寸以適配在用於輸送至該治療部位之該導管的該內腔內的一壓縮構形,及當該可擴張元件未完全植入於該治療部位處時的一部分植入構形。在該部分植入構形中,該可擴張元件的該近端可係定尺寸以適配在該導管的該內腔內,且該遠端可係定尺寸而大於該導管。 The expandable element may have a compressed configuration sized to fit within the lumen of the catheter for delivery to the treatment site, and when the expandable element is not completely implanted at the treatment site Part of the implant configuration. In the partially implanted configuration, the proximal end of the expandable element can be sized to fit within the lumen of the catheter, and the distal end can be sized to be larger than the catheter.
該輸送線可係設置在該導管的該內腔及該可擴張元件內並延伸通過其等,該可擴張元件具有一實質上管狀形狀。該輸送線可具有一近側部分、定位在該近側部分的一遠端處的一近側凸起部件、一遠側部分、定位在該遠側部分的一近端處的一遠側凸起部件、及定位在該近側凸起部件與該遠側凸起之間的一可成形部分。該可成形部分在離開該導管的該內腔時可從一實質上直的構形移動到一彎曲構形。 The delivery line may be arranged in the lumen of the catheter and the expandable element and extend through it, etc., the expandable element having a substantially tubular shape. The delivery line may have a proximal portion, a proximal protrusion member positioned at a distal end of the proximal portion, a distal portion, and a distal protrusion positioned at a proximal end of the distal portion. The lifting part, and a formable part positioned between the proximal protrusion part and the distal protrusion. The formable portion can move from a substantially straight configuration to a curved configuration when leaving the lumen of the catheter.
該可擴張元件可係可藉由該輸送線的一遠側移動而從該壓縮構形移動至該部分植入構形,其可致使該輸送線的該遠側凸起部件與該可擴張元件的該遠側錨定部件接合並朝遠側推動該遠側錨定部件。該遠側錨定部件可係從該導管中排出,而以該遠側凸起部件將該遠側錨定部件推出該導管。 The expandable element can be moved from the compressed configuration to the partially implanted configuration by a distal movement of the delivery line, which can cause the distal protruding part of the delivery line and the expandable element The distal anchoring component engages and pushes the distal anchoring component distally. The distal anchoring component can be expelled from the catheter, and the distal anchoring component can be pushed out of the catheter with the distal protruding component.
在該部分植入構形中,該輸送線可係相對於該可擴張元件朝遠側、朝近側、及旋轉地移動,且當該可擴張元件處於該部分植入構形時,該輸送線的該可成形部分可係移動以從該可擴張元件的該編織部分內提供一徑向力。 In the partially implanted configuration, the delivery line can move distally, proximally, and rotationally relative to the expandable element, and when the expandable element is in the partially implanted configuration, the delivery line The formable portion of the thread can be moved to provide a radial force from within the braided portion of the expandable element.
該可成形部分在該彎曲構形中可係可移動成一對稱弧形形狀、一非對稱弧形形狀、或一大約「S」形狀中的至少一者。 The formable portion may be movable into at least one of a symmetrical arc shape, an asymmetrical arc shape, or an approximately "S" shape in the curved configuration.
該可擴張元件可係處於壓縮構形並完全定位在該導管的該內腔內。當該可擴張元件處於該壓縮構形並完全定位在該導管的該內腔內時,成形的該部分可處於該實質上直的構形並可係定位在該可擴張元件的該編織部分的一腔體內,該遠側凸起部件可係定位在該可擴張元件的該編織部分的該腔體內,且該近側凸起部件可係定位在該近側錨定部件的近側。 The expandable element can be in a compressed configuration and fully positioned within the lumen of the catheter. When the expandable element is in the compressed configuration and is fully positioned within the lumen of the catheter, the shaped portion can be in the substantially straight configuration and can be positioned on the braided portion of the expandable element In a cavity, the distal protruding component can be positioned in the cavity of the braided portion of the expandable element, and the proximal protruding component can be positioned proximal to the proximal anchoring component.
該可擴張元件可處於該部分植入構形,使得該可擴張元件的該遠端係定位在該導管外,且該可擴張元件的該近端及該近側錨定件係定位在該導管的該內腔內。當該可擴張元件處於該部分植入構形時,該輸送線的該可成形部分可處於該彎曲構形並定位在該導管外,且該輸送線相對於該可擴張元件的一旋轉可擴張該可擴張元件的一半徑。 The expandable element may be in the partially implanted configuration such that the distal end of the expandable element is positioned outside the catheter, and the proximal end of the expandable element and the proximal anchor are positioned on the catheter的内内内。 In the cavity. When the expandable element is in the partially implanted configuration, the formable portion of the delivery line can be in the curved configuration and positioned outside the catheter, and a rotation of the delivery line relative to the expandable element can expand A radius of the expandable element.
用於植入一支架的一實例方法可包括以下步驟:提供一植入系統,該植入系統包含一導管、一可擴張元件、及一輸送線;移動該可擴張元件的一第一部分以離開該導管;將該可擴張元件的一第二部分維持在該導管內以建立一部分植入構形;在該部分植入構形中獨立於該可擴張元件移動該輸送線;及回應於該移動該輸送線而擴大該可擴張元件的一圓周。該方法可進一步包括以下步驟:將一近側錨定件定位在該可擴張元件的一近端處;將一遠側錨定件定位在該可擴張元件的一遠端處;將一遠側凸起定位在該輸送線上;將一近側凸起在該輸送線上定位於該遠側凸起的近側;將該遠側凸起定位在該可擴張元件的一腔體內;將該近側凸起定位在該可擴張元件的近側;將該可擴張元件及該輸送線的至少一部分定位在該導管的一腔體內;及藉由朝遠側推動該輸送線而將該遠側錨定件及該可擴張元件朝遠側移動穿過該導管的該腔體,從而將該遠側凸起抵靠該遠側錨定件推動;藉由朝遠側推動該輸送線而從該導管的 該遠端排出該近側錨定件,從而將該近側凸起抵靠該近側錨定件推動;及擴張經排出的該近側錨定件。 An example method for implanting a stent may include the steps of: providing an implant system that includes a catheter, an expandable element, and a delivery line; and moving a first portion of the expandable element away The catheter; maintaining a second portion of the expandable element within the catheter to establish a part of the implant configuration; moving the delivery line independently of the expandable element in the partial implant configuration; and in response to the movement The conveying line expands a circumference of the expandable element. The method may further include the steps of: positioning a proximal anchor at a proximal end of the expandable element; positioning a distal anchor at a distal end of the expandable element; positioning a distal Positioning the protrusion on the delivery line; positioning a proximal protrusion on the delivery line on the proximal side of the distal protrusion; positioning the distal protrusion in a cavity of the expandable element; the proximal side The protrusion is positioned on the proximal side of the expandable element; the expandable element and at least a portion of the delivery line are positioned within a cavity of the catheter; and the distal side is anchored by pushing the delivery line distally The member and the expandable element move distally through the cavity of the catheter, thereby pushing the distal protrusion against the distal anchor; by pushing the delivery wire distally from the catheter The distal end expels the proximal anchor, thereby pushing the proximal protrusion against the proximal anchor; and expands the expelled proximal anchor.
移動該可擴張元件的一第一部分以離開該導管的該步驟可包括以下步驟:藉由朝遠側推動該輸送線而將該遠側錨定件從該導管的一遠端排出,從而將該遠側凸起抵靠該遠側錨定件推動;及擴張經排出的該遠側錨定件。 The step of moving a first part of the expandable element away from the catheter may include the step of expelling the distal anchor from a distal end of the catheter by pushing the delivery wire distally, thereby expelling the The distal protrusion is pushed against the distal anchor; and the expelled distal anchor is expanded.
在該部分植入構形中獨立於該可擴張元件移動該輸送線的該步驟可包括將該近側錨定件維持在該導管的該腔體內的該步驟。 The step of moving the delivery line independently of the expandable element in the partially implanted configuration may include the step of maintaining the proximal anchor within the cavity of the catheter.
回應於該移動該輸送線而擴大該可擴張元件的一圓周的該步驟可包括從該可擴張元件的該腔體內提供自該輸送線抵靠該可擴張元件的一徑向力的該步驟。 The step of expanding a circumference of the expandable element in response to the moving of the delivery line may include the step of providing a radial force from the delivery line against the expandable element from the cavity of the expandable element.
該方法可進一步包括以下步驟:在該輸送線的一部分從該導管的該腔體內朝遠側移動到該導管的該腔體外的一位置時,將該部分從一實質上直的構形定形狀成一彎曲構形;將該輸送線的成形的該部分從該可擴張元件的該腔體內抵靠該可擴張元件滑動;藉由抵靠該可擴張元件移動成形的該部分,將該可擴張元件的一部分延伸到一血管壁;及移動該可擴張元件的該第二部分以藉由以該輸送線的一遠側移動朝遠側推動該可擴張元件而離開該導管及變得植入。 The method may further include the step of shaping the part of the delivery line from a substantially straight configuration as the part of the delivery line is moved distally from inside the cavity of the catheter to a position outside the cavity of the catheter Into a curved configuration; the shaped part of the delivery line slides against the expandable element from the cavity of the expandable element; by moving the shaped part against the expandable element, the expandable element A portion of the expandable element extends to a blood vessel wall; and the second portion of the expandable element is moved to leave the catheter and become implanted by pushing the expandable element distally with a distal movement of the delivery line.
用於植入一支架或其他此類可擴張元件的一實例系統可包括一導管、一編織支架、及一輸送線。該編織支架可移動至一部分植入構形,其特徵在於在該導管外部之該編織支架的一部分及在該導管內之該編織支架的一部 分,且該輸送線可係可獨立於該編織支架移動,及當該編織支架處於一部分植入構形時可移動以提供打開該編織支架的一力。 An example system for implanting a stent or other such expandable element may include a catheter, a braided stent, and a delivery wire. The braided stent can move to a part of the implanted configuration, and is characterized by a part of the braided stent outside the catheter and a part of the braided stent inside the catheter Moreover, the delivery line can be movable independently of the braided stent, and can move when the braided stent is in a partial implant configuration to provide a force to open the braided stent.
該編織支架可係在一壓縮構形中移動通過該導管,且可從該壓縮構形移動到該部分植入構形。該系統的該編織支架可具有在一遠端處的一第一可擴張錨定件及在一近端處的一第二可擴張錨定件,使得在該部分植入構形中,該第一可擴張錨定件係在該導管之遠側的一植入位置擴張,且該第二可擴張錨定件係壓縮在該導管內。 The braided stent can be moved through the catheter in a compressed configuration and can be moved from the compressed configuration to the partially implanted configuration. The braided stent of the system may have a first expandable anchor at a distal end and a second expandable anchor at a proximal end, so that in the partially implanted configuration, the second expandable anchor An expandable anchor is attached to an implantation location on the distal side of the catheter to expand, and the second expandable anchor is compressed in the catheter.
當該編織支架處於該部分植入構形時,該輸送線可係可獨立於該編織支架沿一遠側方向、一近側方向、及一旋轉方向移動。當該編織支架處於該壓縮構形時及當該編織支架處於該部分植入構形時,該輸送線可延伸穿過該編織支架。 When the braided stent is in the partially implanted configuration, the delivery line can be moved independently of the braided stent in a distal direction, a proximal direction, and a rotation direction. When the braided stent is in the compressed configuration and when the braided stent is in the partially implanted configuration, the delivery wire can extend through the braided stent.
該輸送線可包括一推動器凸起,當該編織支架處於該壓縮構形時及當該編織支架處於該部分植入構形時,該推動器凸起可係定位在該第二可擴張錨定件的近側。該推動器凸起可係可移動以朝遠側推動該第二可擴張錨定件,從而當該編織支架處於該部分植入構形時朝遠側推動該編織支架。 The delivery line may include a pusher protrusion, and when the braided stent is in the compressed configuration and when the braided stent is in the partially implanted configuration, the pusher protrusion may be positioned on the second expandable anchor The near side of the fixed piece. The pusher protrusion may be movable to push the second expandable anchor distally, thereby pushing the braided stent distally when the braided stent is in the partially implanted configuration.
該輸送線可包括一可成形區段,當該編織支架處於該壓縮構形時及當該編織支架處於該部分植入構形時,該可成形區段可係定位於該編織支架內。該可成形區段可係可從該編織支架處於該壓縮構形時的一實質上直的構形移動至該編織支架處於該部分植入構形時的一彎曲構形,且當該編織支架處於該部分植入構形時,該可成形區段可係可獨立於該編織支架移動。當處於該彎曲構形時,該可成形區段可係可移動以形成一弧形形狀、一波狀(undulating)形狀、或其他無創傷(atraumatic)形狀。 The delivery line can include a formable section that can be positioned within the braided stent when the braided stent is in the compressed configuration and when the braided stent is in the partially implanted configuration. The formable section may be movable from a substantially straight configuration when the braided stent is in the compressed configuration to a curved configuration when the braided stent is in the partially implanted configuration, and when the braided stent is When in the partially implanted configuration, the formable section can be moved independently of the braided stent. When in the curved configuration, the formable section may be movable to form an arc shape, an undulating shape, or other atraumatic shape.
該輸送線可包括一拉動器凸起,當該編織支架處於該壓縮構形時,該拉動器凸起係定位在該推動器凸起及該可成形區段的遠側且亦定位在該第一可擴張錨定件的近側。 The delivery line may include a puller protrusion. When the braided stent is in the compressed configuration, the puller protrusion is positioned on the far side of the pusher protrusion and the formable section and also positioned on the first The proximal side of an expandable anchor.
10‧‧‧體腔/腔體/脈管系統/血管 10‧‧‧Body cavity/cavity/vasculature/vascular
100‧‧‧植入系統/設備 100‧‧‧Implant System/Equipment
102‧‧‧導管 102‧‧‧Conduit
104‧‧‧內腔 104‧‧‧Inner cavity
106‧‧‧輸送線 106‧‧‧Conveying line
108‧‧‧近側部分 108‧‧‧Proximal part
110‧‧‧遠側部分 110‧‧‧Distal part
112‧‧‧可成形部分/成形的部分 112‧‧‧Formable part/formable part
113‧‧‧無創傷區段/無創傷形狀 113‧‧‧Non-traumatic section/Non-traumatic shape
114‧‧‧凸起部件/遠側凸起 114‧‧‧Protrusion part/distal protrusion
144‧‧‧凸起 144‧‧‧Protrusion
116‧‧‧凸起部件/凸起 116‧‧‧Protruding parts/protrusions
120‧‧‧取回凸起/凸起部件/凸起 120‧‧‧Retrieve the protrusion/protrusion part/protrusion
200‧‧‧可擴張元件/植入物/可擴張錨定件 200‧‧‧Expandable element/implant/expandable anchor
201‧‧‧不良貼附部分 201‧‧‧Poorly attached part
202‧‧‧近端 202‧‧‧Proximal
204‧‧‧遠端 204‧‧‧Remote
206‧‧‧編織部分/中間部分 206‧‧‧Knitting part/Middle part
208‧‧‧錨定部件/錨定件 208‧‧‧Anchor Parts/Anchor Parts
210‧‧‧錨定部件/錨定件 210‧‧‧Anchor Parts/Anchor Parts
220‧‧‧遠側線圈 220‧‧‧Distal coil
700‧‧‧方法 700‧‧‧Method
710‧‧‧步驟 710‧‧‧Step
720‧‧‧步驟 720‧‧‧Step
730‧‧‧步驟 730‧‧‧Step
740‧‧‧步驟 740‧‧‧Step
750‧‧‧步驟 750‧‧‧step
參見以下具體實施方式並結合圖式進一步討論本發明的上述態樣及進一步態樣,在圖式中,相同的編號指示各種圖中相同的結構元件及特徵。圖式中的影像及圖示未必按比例繪製,而係將重點放在繪示本發明的原理。如指示者,圖式僅以舉例方式而非限制方式描繪本發明裝置的一或多種實施方案。 The above aspects and further aspects of the present invention are further discussed with reference to the following specific embodiments in conjunction with the drawings. In the drawings, the same numbers indicate the same structural elements and features in the various drawings. The images and illustrations in the drawings are not necessarily drawn to scale, but the emphasis is placed on depicting the principles of the present invention. As indicated, the drawings depict one or more implementations of the device of the present invention by way of example only and not by way of limitation.
圖1係描繪根據本發明的處於輸送構形的植入系統的圖示; Figure 1 is a diagram depicting an implant system in a delivery configuration according to the present invention;
圖2A至圖2H係繪示根據本發明的用於植入系統的步驟的圖示; 2A to 2H are diagrams showing the steps of the implantation system according to the present invention;
圖3A至圖3C係描繪根據本發明的輸送線部分的形狀的圖示; 3A to 3C are diagrams depicting the shape of the conveying line part according to the present invention;
圖4係描繪所屬技術領域中已知的編織植入物的影像,該編織植入物具有不良地附於血管壁的區段; Figure 4 depicts an image of a braided implant known in the art, the braided implant has a section that is poorly attached to the blood vessel wall;
圖5係描繪根據本發明的植入期間的植入系統的影像; Figure 5 depicts an image of the implant system during implantation according to the present invention;
圖6A至圖6C係繪示根據本發明的用於植入系統的步驟的影像;及 6A to 6C are images showing the steps of the implantation system according to the present invention; and
圖7係概述根據本發明的用於部署植入物的設備或系統的實例方法步驟的流程圖。 Fig. 7 is a flowchart outlining example method steps of a device or system for deploying an implant according to the present invention.
在以下詳細描述中,藉由實例闡述許多具體細節以提供相關教示的徹底理解。然而,應對於所屬技術領域中具有通常知識者顯而易見的是,可在沒有此類細節的情況下實施本教示。在其他例項中,為了避免不必要地模糊本教示的態樣,已在相對較高的位階上(無細節)描述熟知的方法、程序、組件、及/或電路系統。 In the following detailed description, many specific details are explained through examples to provide a thorough understanding of relevant teachings. However, it should be obvious to those with ordinary knowledge in the technical field that the teachings can be implemented without such details. In other examples, in order to avoid unnecessarily obscuring the teachings, well-known methods, procedures, components, and/or circuit systems have been described at a relatively high level (without details).
如圖1所示,植入系統100的實例可具有導管102、可擴張元件200、和輸送線106。導管102可具有內腔104,並且可擴張元件200可係形成為壓縮構形,該壓縮構形係定尺寸以適配在導管102的內腔104內。可擴張元件200可具有:近端202、遠端204、定位在近端202與遠端204之間的編織部分206、設置在近端202處的近側錨定部件208、及設置在遠端204處的遠側錨定部件210。輸送線106可係設置在導管102的內腔104和可擴張元件200內並延伸通過其等,並且可用以將可擴張元件200輸送到治療部位及將可擴張元件200定位在治療部位處。輸送線106可具有:近側部分108、遠側部分110、定位在近側部分108的遠端處的近側凸起部件114、定位在遠側部分110的近端處的遠側凸起部件114、及定位在近側凸起部件116與遠側凸起部件114之間的可成形部分112。當可擴張元件200處於壓縮構形以用於輸送通過導管102時,可成形部分112可具有實質上直的形狀,其具有可撓性以通過導管102引導到治療部位。
As shown in FIG. 1, an example of an
輸送線106可進一步包括定位在遠側凸起114與近側凸起116之間的取回凸起120。利用具有遠側凸起部件、近側凸起部件、和取回凸起的輸送線在體腔內輸送、定位、回縮諸如支架的可擴張元件係與本申請案同時申請的另一專利申請案的主題。
The
凸起部件114、116、120中的一者或全部可包括不透輻射材料,以允許凸起144、116、120的位置在植入程序期間易於看見。
One or all of the raised features 114, 116, 120 may include a radiopaque material to allow the location of the
一或多個錨定部件208、210可係突出部,該等突出部大致平行於可擴張元件200的縱軸延伸及朝可擴張元件200的縱軸向下延伸。在將可擴張元件200部署在體腔10內期間,錨定部件208、210可作用為不透輻射標記,以用於改善可視化。錨定部件208、210可係用以對準可擴張元件200,所以其可被推動及拉動穿過導管102而不損壞或變形。錨定部件208、210亦可係用以將編織部分206移動至擴張/植入構形。錨定部件208、210的實例可見於美國序號第15/299,918號,該案全文以引用方式併入本文中。
The one or
一般而言,可擴張元件200可具有壓縮構形及擴張的植入構形。處於壓縮構形時,可擴張元件200可經定尺寸以適配在導管102的內腔104內。在某些實例中,導管102可有助於限制可擴張元件200,所以其當含在導管102內時不擴張。其他元件可係用以限制可擴張元件200,如所屬技術領域已知。
Generally speaking, the
可擴張元件200亦可具有部分植入構形,其中近端202經定尺寸以適配在導管102的內腔104內,並且遠端204經定尺寸而大於導管102。
The
圖2A至圖2H係繪示用於植入系統的步驟的圖示。當可擴張元件200處於塌縮構形時,遠側凸起114可係定位在可擴張元件200內,使得輸送線106的遠側移動可致使遠側凸起114抵靠遠側錨定件210推動,而將可擴張錨定件200通過導管102拉動到治療部位。遠側凸起部件114可推動遠側錨定部件210以將遠側錨定部件210從導管102排出,從而將可擴張元件200移動到部分植入構形,如圖2A所示。
2A to 2H are diagrams showing steps for implanting the system. When the
在離開導管時,輸送線106的可成形部分112可從直的形狀移動到彎曲形狀,如圖2A至圖2H所示。當可擴張元件處於部分植入構形時,可成形部分112可從可擴張元件200的編織部分206內提供徑向力。
Upon exiting the catheter, the
在一實例中,包括可成形部分112的整個輸送線106可係由不鏽鋼製成。在其他實例中,輸送線106及/或可成形部分112可係由記憶形狀材料製成,該記憶形狀材料包括記憶形狀金屬,諸如鎳鈦諾或聚合記憶形狀材料。在離開導管102時,可成形部分112可從處於導管102中時的實質上直的可撓性構形移動到接觸體液後的彎曲構形。額外地或替代地,可成形部分112可彎曲以適形於彎曲體腔的形狀,使得可擴張元件200、輸送線106、和導管102的遠側移動和近側移動可致使輸送線106移動以從編織部分206內提供徑向力。
In an example, the
如圖2A所示,在治療期間,因為自擴張編織植入物可在植入期間提供低徑向力,所以可擴張元件200的中間部分206之至少一些者可能不完全適形於體腔10的壁。
As shown in FIG. 2A, during treatment, because the self-expanding braided implant can provide low radial force during implantation, at least some of the
如圖2B所示,輸送線106可係可相對於可擴張元件200旋轉,並且旋轉可致使輸送線106的成形的部分112提供抵靠可擴張元件200的力,而推動可擴張元件的部分以適形於體腔10的壁。
As shown in FIG. 2B, the
如圖2C所示,輸送線106可係可相對於可擴張元件200在遠側方向和近側方向移動,而不會干擾部分植入的可擴張元件200的放置。遠側移動和近側移動亦可致使輸送線106的成形的部分112抵靠可擴張元件200移動,而致使可擴張元件200的部分更好地適形於體腔10的壁。
As shown in FIG. 2C, the
如圖2D所示,輸送線106可係隨後旋轉以改善可擴張元件200與體腔10的壁的適形度。
As shown in FIG. 2D, the
如圖2E所示,當可擴張元件200處於部分植入構形時,輸送線106可進一步朝遠側移動以將近側推動器凸起116與近側錨定件208接合。
As shown in FIG. 2E, when the
如圖2F所示,輸送線106的進一步遠側移動可將近側錨定件208從導管102排出。一旦將近側錨定件208從導管102排出,近側錨定件可擴張以接合體腔10的壁。一旦近側錨定件208經擴張,可擴張元件200可從輸送線106脫離。如圖2F所示,可擴張元件200的部分可保持不完全適形於體腔10的壁。
As shown in FIG. 2F, further distal movement of the
如圖2G所示,輸送線106隨後可係朝近側移動以側靠編織物的部分,而導致對體腔10的壁之更佳適形度。
As shown in FIG. 2G, the
如圖2H所示,輸送線106隨後可經旋轉,並且成形的部分112可抵靠編織物的部分滑動,而導致對體腔10的壁之更佳適形度。
As shown in FIG. 2H, the conveying
在擴張構形中,如圖2H所示,可擴張元件200可經擴張以適形於患者體腔10的尺寸。可擴張元件200的擴張尺寸允許設備100穿過其中,以前移到第二位置或被抽出。可擴張元件200在其固有的性質下可係至少部分可擴張的,至少基於其初始形狀及構成該元件的材料的本質,並且藉由如本文所述之輸送線106的移動來進一步擴張。當處於其擴張直徑時,可擴張元件200的實例可係梨形、卵形、及橢圓形中的一者。可擴張元件200的構造對於所屬技術領域中具有通常知識者而言是已知的。設想用於本揭露的可擴張元件200的其他實施例,並且亦可在美國專利公開案第2016/0058524號中觀察到,其全文以引用方式併入本文。
In the expanded configuration, as shown in FIG. 2H, the
圖3A至圖3C繪示當可擴張元件處於部分植入構形時,輸送線106的可成形部分112可具有的一些潛在形狀。弧形、彎曲、「S」形、和「C」形係一些實例。在一實例中,可成形部分112呈現無創傷區段113以接觸編織植
入物200和可能的體腔10的壁兩者。無創傷區段113使對植入物200和腔體10的一者或兩者的損害最小化。無創傷區段113的另一實例係一旦可成形部分112從直的形狀變形成彎曲形狀就使所施加的徑向力的量最小化。太大的力(甚至由無創傷形狀113施加)仍然可損壞植入物/腔體。太小的力或形狀和植入物將不會打開到其完全的潛在形狀。
3A to 3C illustrate some potential shapes that the
圖4描繪所屬技術領域中已知的編織植入物,該編織植入物具有不良地附於血管壁的區段。本發明的一目的係提供用於改善植入物對血管壁的適形度的治療裝置、系統、和方法。 Figure 4 depicts a braided implant known in the art, the braided implant having a section that is poorly attached to the blood vessel wall. An object of the present invention is to provide a treatment device, system, and method for improving the conformity of the implant to the blood vessel wall.
圖5描繪部分植入的可擴張元件,該可擴張元件係編織植入物200,該編織植入物具有定位在導管102外的遠端204和定位在植入物200內的輸送線106,輸送線106具有定位在植入物200之遠側的遠側線圈220、定位在植入物內的遠側凸起114、定位在植入物200內遠側凸起114之近側的取回凸起120、及定位在導管102內植入物200之近側的近側凸起116。如圖5所描繪的植入物200具有未延伸以適形於脈管系統10的不良貼附部分201。
Figure 5 depicts a partially implanted expandable element that is a
圖6A至圖6C繪示在圖5所示系統內的輸送線106的移動,以從不良貼附部分201及植入物200的未完全附於壁的其他部分內提供向外徑向力,以將該等部分移動更靠近血管10的壁。從圖6A進展至圖6B,輸送線106可係朝遠側移動以抵靠植入物200的外彎曲部分延伸及/或藉由近側凸起116提供抵靠植入物200的近側錨定件(未圖示)的推動力。從圖6B進展至圖6C,輸送線106可係朝近側拉動以壓抵植入物200的內彎曲部分及/或將植入物200的至少一部分回縮到導管102中。
6A to 6C illustrate the movement of the
在圖6A至圖6C所示的實例中,輸送線106的成形的部分112可係可撓性的以彎曲成彎曲脈管系統10的形狀,並且由於由記憶形狀材料製成而不需要重新成形。可成形部分112可單獨地彎曲以適形於彎曲體腔的形狀,使得可擴張元件200、輸送線106、和導管102的遠側移動和近側移動可致使輸送線移動以從編織部分206內提供徑向力。在此實例中,非預成形的可成形部分112可基於將輸送線106帶到穿過彎曲部內及待植入之編織部分206的脈管系統的彎曲部外而彎曲。
In the example shown in FIGS. 6A to 6C, the shaped
圖7係概述用於部署植入物的設備或系統的實例方法步驟的流程圖。該等方法步驟可藉由本文所述的實例手段或藉由所屬技術領域中具有通常知識者已知的任何手段來實現。 Figure 7 is a flowchart outlining example method steps of a device or system for deploying an implant. These method steps can be implemented by the example means described herein or by any means known to those with ordinary knowledge in the art.
參考圖7所示的方法700,在步驟710中,可提供具有導管、可擴張元件、及輸送線的植入輸送系統。植入輸送系統可係本文所述的輸送系統中的任一者,其具有在此所述特徵之任何組合以及所屬技術領域中具有通常知識者已知的任何特徵。在步驟720中,可移動可擴張元件的第一部分以離開導管。在步驟730中,可將可擴張元件的第二部分維持在導管內以建立部分植入構形。在步驟740中,在部分植入構形中,可獨立於可擴張元件移動輸送線。在步驟750中,可回應於步驟740中之輸送線的移動而擴大可擴張元件的圓周。
Referring to the
本文所包含的描述是本發明的實施方案的實例,並且不旨在以任何方式限制本發明的範圍。如本文所述,本發明設想植入系統及其使用方法的許多變化和修改,包括輸送線的可成形部分的各種形狀、各種材料、各種治療、和各種支架幾何形狀。這些修改將對本發明所屬技術領域中具有通常知識者顯而易見,並且旨在處於以下申請專利範圍的範疇內。 The description contained herein is an example of an embodiment of the invention and is not intended to limit the scope of the invention in any way. As described herein, the present invention envisions many variations and modifications of the implant system and its method of use, including various shapes, various materials, various treatments, and various stent geometries of the formable portion of the delivery line. These modifications will be obvious to those with ordinary knowledge in the technical field to which the present invention belongs, and are intended to be within the scope of the following patent applications.
10‧‧‧體腔/腔體/脈管系統/血管 10‧‧‧Body cavity/cavity/vasculature/vascular
100‧‧‧植入系統/設備 100‧‧‧Implant System/Equipment
102‧‧‧導管 102‧‧‧Conduit
104‧‧‧內腔 104‧‧‧Inner cavity
106‧‧‧輸送線 106‧‧‧Conveying line
108‧‧‧近側部分 108‧‧‧Proximal part
110‧‧‧遠側部分 110‧‧‧Distal part
112‧‧‧可成形部分/成形的部分 112‧‧‧Formable part/formable part
114‧‧‧凸起部件/遠側凸起 114‧‧‧Protrusion part/distal protrusion
116‧‧‧凸起部件/凸起 116‧‧‧Protruding parts/protrusions
120‧‧‧取回凸起/凸起部件/凸起 120‧‧‧Retrieve the protrusion/protrusion part/protrusion
200‧‧‧可擴張元件/植入物/可擴張錨定件 200‧‧‧Expandable element/implant/expandable anchor
202‧‧‧近端 202‧‧‧Proximal
204‧‧‧遠端 204‧‧‧Remote
206‧‧‧編織部分/中間部分 206‧‧‧Knitting part/Middle part
208‧‧‧錨定部件/錨定件 208‧‧‧Anchor Parts/Anchor Parts
210‧‧‧錨定部件/錨定件 210‧‧‧Anchor Parts/Anchor Parts
220‧‧‧遠側線圈 220‧‧‧Distal coil
Claims (18)
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