JP2011147791A - System and method for supplying blocking device in vascular tract for expansion - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a system and a method for expanding a blocking device for use in re-forming aneurysm in a vascular tract for example by a neck reconstructing technique or a balloon re-forming. <P>SOLUTION: The system includes an introducing sheath 10 and an assembly for supporting a blocking device 100. The assembly comprises: a long flexible member 21 having a blocking device holding member for receiving a first end part of the blocking device; a retention member positioned on the proximal end side for the purpose of engaging with a second end part of the blocking device; and a support body surrounding a part of the long flexible member; thus, the assembly can situate the blocking device on the support body. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

Field of Invention

  [01] The present invention relates generally to systems and methods for delivering and deploying medical devices within a duct, and more particularly within a patient's vasculature to close and close an aneurysm, particularly a cerebral aneurysm. The present invention relates to a system and method for supplying and deploying an endoluminal therapy device.

Background of the Invention

  [02] The walls of the vasculature, especially the arterial walls, may develop a pathologic dilation called an aneurysm. As is well known, aneurysms have thin and weak walls that are easy to rupture. An aneurysm can be said to be the result of a weakened vessel wall due to illness, injury or a congenital abnormality. Aneurysms can be found in various parts of the body, the most common being cerebral aneurysms and abdominal aortic aneurysms within the neurovasculature. If the weakened wall of the aneurysm ruptures, it can be fatal, especially if it is a cerebral aneurysm rupture.

  [03] Aneurysms are generally treated by removing weakened portions of the blood vessels from the arterial circulation. To treat a cerebral aneurysm, such reinforcement includes (i) surgical clipping in which a metal clip is secured around the base of the aneurysm, (ii) arteries using small flexible wire coils (microcoils) Enveloping the aneurysm (iii) “filling” the aneurysm using an embolic material, (iv) occluding the parent vessel providing the aneurysm using a removable balloon or coil, (v) endovascular stent placement It is done in many ways, including art.

  [04] Intravascular stents are well known in the medical arts for the treatment of vascular stenosis or aneurysms. A stent is a prosthesis that expands radially or otherwise within a blood vessel or lumen to provide support against vessel collapse. Methods for delivering these intravascular stents are also well known.

  [05] In conventional methods of introducing a compressed stent into a blood vessel and positioning the stent within a stenotic region or aneurysm, a guide catheter having a tip is introduced percutaneously into the patient's vasculature. The The guide catheter is pushed into the blood vessel until its distal tip is closest to the stenosis or aneurysm. A guide wire positioned within the inner lumen of the second inner catheter and the inner catheter are advanced through the distal end of the guide catheter. Thereafter, the guide wire is advanced from the distal end of the guide catheter into the blood vessel until the distal end of the guide wire supporting the compression stent is positioned at a lesion point in the blood vessel. Once the compressed stent is positioned in the lesion, the stent can be released and expanded so that the stent supports the blood vessel.

  [06] Aspects of the invention include systems and methods for deploying an occlusion device within a conduit. The occlusion device can be used to recreate an aneurysm in the duct, for example by neck reconstruction or balloon remodeling. The occlusion device is used to form a barrier that retains occlusion material such as microtherapy (ONYX) or other well-known coils in the aneurysm so that the introduced material does not escape from within the aneurysm Can be used. Also, during deployment, the length of the occlusion device can be adjusted according to the friction formed between the occlusion device and the inner surface of the catheter. When this is done, the deployment length and circumferential size of the closure device can be varied as desired by the treating physician.

  [07] One aspect of the present invention includes a system for supporting and deploying an occlusion device. The system includes an introducer sheath and an assembly for supporting the occlusion device. The assembly includes an elongate flexible member having an occlusion device retaining member for receiving a first end of the occlusion device, and a proximally located retention member for engaging the second end of the occlusion device And a support body surrounding a part of the long flexible member, and the closure device can be positioned on the support body.

  [08] Another aspect of the invention includes a system for supporting and deploying an occlusion device. The system includes an assembly for supporting the occlusion device. The assembly includes an elongate member including a flexible tip portion, a holding member for receiving the first end of the occlusion device, and a support for surrounding the portion of the elongate flexible member to support the occlusion device. With.

  [09] A further aspect of the invention includes a method of introducing and deploying an occlusion device in a conduit. The method includes introducing an elongate sheath including an introducer sheath that supports the guidewire assembly into the catheter and pushing the guidewire assembly out of the sheath and into the catheter. The method also includes positioning the end of the catheter closest to the aneurysm, pushing a portion of the guidewire assembly out of the catheter, and deploying the occlusion device in the area of the aneurysm. Rotating a part.

Detailed Description of the Invention

  [21] An occluder supply assembly having a small cross-section and a very flexible occluder supply assembly will now be described. FIG. 1 shows an introducer sheath 10 according to one aspect of the present invention that receives and houses an occlusion device 100 and supplies the occlusion device 100 to a flexible microcatheter 1 for positioning within the individual's vasculature. Show. The occlusion device 100 is a co-pending US patent application (Attorney Docket No.006258.01010), filed on May 25, 2005, which is incorporated herein by reference in its entirety (FLEXIBLE VASCULAR OCCLUDING DEVICE). ) Can be included.

  [22] As shown in FIGS. 1 and 2, the distal end 12 of the introducer sheath 10 is sized and configured to be received within the hub 2 of the microcatheter 1. The hub 2 can be located at the proximal end of the microcatheter 1, or it can be located elsewhere along the length of the microcatheter 1. The microcatheter 1 may be any known microcatheter that can be introduced and pushed through the patient's vasculature. In one embodiment, the microcatheter has an inner diameter of 0.047 inches or less. In other embodiments, the microcatheter has an inner diameter of about 0.027 inches to about 0.021 inches. In other possible embodiments, the microcatheter can have an inner diameter of about 0.025 inches. However, it is contemplated that the catheter 1 can have an inner diameter that is greater than 0.047 inches or less than 0.021 inches. After the introducer sheath 10 is positioned within the catheter hub 2, the occlusion device 100 can be pushed from the introducer sheath 10 into the microcatheter 1 in preparation for deployment of the occlusion device 100 within the patient's vasculature.

  [23] The microcatheter 1 may have at least one fluid introduction port 6 located adjacent to the hub 2 or located elsewhere along its length. The port 6 is in fluid communication with the tip of the microcatheter 1 so that air or debris trapped in the microcatheter 1 is passed through the microcatheter 1 prior to insertion into the vasculature, eg, saline. Preferably, any instrument such as a guidewire positioned within the microcatheter can be washed away. Port 6 may also be used to deliver drug or fluid into the vasculature as desired.

  [24] FIG. 3 shows an introducer sheath 10, an elongate flexible supply guidewire assembly 20 movable within the introducer sheath 10, and an occlusion device 100. FIG. As shown, the guide wire assembly 20 and the occlusion device 100 supported by the guide wire assembly 20 are not introduced into the microcatheter 1. Instead, they are located within the introducer sheath 10 as shown. The introducer sheath 10 may be formed from a variety of thermoplastics, such as PTFE, FEP, HDPE, PEEK, etc., optionally with a hydrophilic material such as PVP or some other plastic coating on the inner or adjacent surface of the sheath It may be covered with. Also, depending on the desired result, any surface may be coated with various combinations of different materials.

  [25] The introducer sheath 10 may include a drainage port or purge hole (not shown) formed in the wall near the region covering the occlusion device 100. A single hole or multiple holes, eg, three holes, may be formed in the introducer sheath 10. These purge holes allow the introducer sheath 10 and guidewire assembly 20 to be removed when purging the sheath prior to placing the introducer sheath 10 in contact with the catheter hub 2, for example, to remove trapped air or debris. A fluid such as physiological saline can be easily escaped from between.

  [26] As shown in FIG. 4, the guidewire assembly 20 includes an elongate flexible guidewire 21. The flexibility of the guidewire 21 allows the guidewire assembly 20 to bend as necessary to conform to the curvature of the vasculature and positionally move the occlusion device 100 within the vasculature. The guide wire 21 may be formed of a conventional guide wire material and may have a solid cross section. Alternatively, the guide wire 21 can be formed by a hypotube. In either embodiment, guidewire 21 has a diameter D5 in the range of about 0.010 inches to about 0.020 inches. In one embodiment, guide wire 21 has a maximum diameter of about 0.016 inches. The material used for the guidewire 21 may be any well-known guidewire material including a superelastic metal such as Nitinol. Alternatively, the guide wire 21 can be formed of a metal such as stainless steel. The guide wire length L4 may be between about 125 cm and 190 cm. In one embodiment, the length L4 is about 175 cm.

  [27] The guidewire assembly 20 can have the same degree of curvature along its entire length. In other embodiments, the guidewire assembly 20 can have a plurality of longitudinal sections, each longitudinal section having a different degree of curvature / rigidity. Different degrees of curvature in the guidewire assembly 20 can be formed using different materials and / or thicknesses in different longitudinal sections of the guidewire 21. In other embodiments, the curvature of the guidewire 21 can be controlled by spaced notches (not shown) formed in the supply guidewire 21. These cuts can be spaced apart from one another in the longitudinal direction and / or in the circumferential direction. The notch can be accurately formed in the supply guidewire 21. Different sections of the supply guidewire 21 can include cuts formed at different spacings and different depths to give these separate sections different amounts of curvature and stiffness. In any of the foregoing embodiments, the guidewire assembly 20 and guidewire 21 are responsive to torque applied to the guidewire assembly 20 by the operator. As described below, torque applied to the guidewire assembly 20 via the guidewire 21 can be used to release the closure device 100 from the guidewire assembly 20.

  [28] The size and shape of the cut formed in the supply guidewire 21 may be controlled to provide greater or lesser flexibility. Since the width of the cut can be changed without changing the depth of the cut or the overall shape, even if the flexibility of the supply guide wire 21 can be selectively changed without affecting the torsional strength of the supply guide wire 21. Good. Thus, the flexibility and torsional strength of the supply guidewire 21 may be selectively and independently changed.

  [29] The longitudinally adjacent pairs of cuts are beneficial in that they can be rotated about 90 degrees relative to each other in the circumferential direction of the supply guidewire 21 to bend in the lateral and vertical directions. However, the cuts may be placed in place to provide selective bending in one or more desired directions. Of course, the cuts can be randomly formed to allow bending evenly in all directions or evenly in the plane. In one embodiment, this can be achieved by spacing the notches circumferentially.

  [30] The flexible supply guidewire 21 can include any number of sections having the same or different degrees of curvature. For example, the flexible supply guide wire 21 can include more than one section. In the embodiment shown in FIG. 4, the flexible supply guidewire 21 includes three sections, each section having a different diameter. Each section can have a diameter of about 0.005 inches to about 0.025 inches. In one embodiment, the diameter of one or more sections may be from about 0.010 inches to about 0.020 inches. The first section 22 includes a proximal end 23 positioned opposite the position of the occluding device 100. The first section 22 can have a constant thickness along its length. Alternatively, the first section 22 can have a thickness (diameter) that tapers over its entire length or only a portion of its length. In a tapered embodiment, the thickness (diameter) of the first section 22 decreases in the direction of the second transition section 24. In embodiments where the guidewire 21 has a circular cross section, the thickness is the diameter of the section.

  [31] The second transition section 24 extends between the first section 22 and the third tip section 26. The second section 24 gradually decreases in thickness from the large diameter of the first section 22 to the small diameter of the third section 26. Similar to the first section 22, the second section 24 can taper over its entire length or over only a portion of its length.

  [32] The third section 26 has a small thickness compared to the other sections 22, 24 of the supply guidewire 21. The third section 26 extends away from the tapered second section 24 that supports the occlusion device 100. The third section 26 can taper over its entire length from the second section 24 to the tip 27 of the supply guidewire 21. Alternatively, the third section 26 can have a constant diameter or can taper over only a portion of its length. In such an embodiment, the tapered portion of the third section 26 is one spaced from the tip 27 of the supply guidewire 21 from one point spaced from the second section 24 or from the second section 24. Can extend to one point. Although three sections of the supply guidewire 21 have been described and illustrated, the supply guidewire 21 can include more than two sections. Also, each of these sections can be progressively reduced in thickness (diameter) over their entire length or only a portion of their length. In any disclosed embodiment, the supply guidewire 21 can be formed from a shape memory alloy such as Nitinol.

  [33] As shown in FIGS. 4 and 5, a tip 28 and a flexible tip coil 29 are fixed to the distal end 27 of the supply guide wire 21. As shown, the tip 28 can include a continuous end cap or cover that securely receives the tip of the tip coil 29. The bending control is performed on the distal end portion of the supply guide wire 21 by the chip coil 29. However, in one embodiment, the chip 28 may not have the coil 29. The tip 28 has a non-percutaneous atraumatic end face. In the illustrated embodiment, the tip 28 has a rounded surface. In other embodiments, the tip 28 can have other non-percutaneous shapes that do not damage the conduit into which it is introduced. As shown in FIG. 4, the tip 28 includes a housing 45 that firmly receives the tip of the guide wire 21 within an opening 46 on the inner surface of the housing 45. The guide wire 21 can be secured in the opening by any known means.

  [34] As shown in FIG. 4, the chip coil 29 surrounds a portion of the guide wire 21. The tip coil 29 is flexible so that when the tip 28 is pushed along the conduit in the patient and the guide wire 21 bends to follow the tortuous path of the vasculature, the tip coil 29 is said to pass through the conduit. It is adapted to follow the path. As illustrated, the chip coil 29 extends rearward from the chip 28 toward the proximal end 23.

  [35] Chip 28 and coil 29 have an outer diameter D1 of about 0.010 inches to about 0.018 inches. In one embodiment, their outer diameter D1 is about 0.014 inches. The chip 28 and the coil 29 have a length L1 of about 0.1 cm to about 3.0 cm. In one embodiment, they have a total length L1 of about 1.5 cm.

  [36] As shown in FIGS. 1 and 4, the proximal end 30 of the tip coil 29 is received in the housing 32 at the distal end 24 of the protective coil 35. Housing 32 and protective coil 35 have an outer diameter D2 of about 0.018 inches to about 0.038 inches. In one embodiment, their outer diameter D2 is about 0.024 inches. The housing 32 and the protective coil 35 have a length L2 of about 0.05 cm to about 0.2 cm. In one embodiment, their total length L2 is about 0.15 cm.

  [37] The housing 32 has a non-percutaneous, non-traumatic shape. For example, as shown in FIG. 5, the housing 32 has a substantially blunt outline. Also, the housing 32 can be dimensioned to open / support the conduit as it passes through the conduit. The housing 32 can also include an angled sidewall dimensioned to be spaced from the inner surface of the introducer sheath 10.

  [38] The housing 32 and protective coil 35 maintain the position of the occlusion device 100 on the flexible guidewire assembly 20 and compress the occlusion device 100 prior to delivery of the occlusion device and deployment within the vasculature conduit. A tip holding member is formed to help hold the state. As shown in FIG. 4, the protective coil 35 extends from the housing 32 toward the proximal end 23 of the supply guidewire 21. The protective coil 35 is fixed to the housing 32 by any known method. In the first embodiment, the protection coil 35 can be fixed to the outer surface of the housing 32. In other embodiments, the protective coil 35 can be secured within the opening of the housing 32 such that the housing 32 surrounds and receives the distal end 51 of the protective coil 35 (FIG. 4). As shown in FIGS. 3 and 4, the distal end 102 of the occlusion device 100 is held within the proximal end 52 so that the occlusion device 100 is positioned within the sheath 10 or the microcatheter 1. It cannot be deployed.

  [39] At the proximal end of the closure device 100, the bumper coil 60 and the cap 62 prevent lateral movement along the length of the guide wire 21 of the closure device 100 in the direction toward the proximal end 23 (see FIG. 3). . Bumper coil 60 and cap 62 have an outer diameter D4 of about 0.018 inches to about 0.038 inches. In one embodiment, their outer diameter D4 is about 0.024 inches. The cap 62 contacts the proximal end 107 of the occluding device 100 and prevents the occluding device from moving along the length of the guide wire 21 away from the protective coil 35. The bumper coil 60 can be in the form of a spring that contacts and presses against the cap 62 in a direction toward the protective coil 35, thereby creating a biasing force against the closure device 100. This biasing force (pressure) helps to maintain a strong covering relationship between the tip 102 of the closure device 100 and the protective coil 35. As with any coil located along the supply guidewire 21, the bumper coil 60 is secured to the supply guidewire 21 by soldering, welding, RF welding, glue, and / or other known adhesives. be able to.

  [40] In another embodiment shown in FIG. 10, the bumper coil 60 is not utilized. Instead, the proximal end 107 of the occlusion device 100 is held in place by a set of spring loaded arms (jaws) 140 while being positioned within the introducer sheath 10 or microcatheter 1. The inner surfaces of the microcatheter 1 and the introducer sheath 10 limit the radial expansion of the arm 140. When the proximal end of the occlusion device comes out of the microcatheter 1, the arm 140 springs open to release the occlusion device, as shown in FIG.

  [41] In other embodiments, the bumper coil 60 and cap 62 can be eliminated and the proximal end of the closure device 100 is held in place relative to the protective coil 35 by the tapered section of the guidewire 21. Can do. In such an embodiment, the enlarged cross-section of this tapered section holds the closure device 100 in place along the length of the supply guidewire 21 and closes the closure device 100 in the direction toward the proximal end 23. Can be used to prevent movement of

  [42] As shown in FIG. 4, the guidewire assembly 20 includes a support 70 for the occlusion device 100. In the first embodiment, the support 70 includes an outer surface of the supply guidewire 21 that is dimensioned to contact the inner surface of the occlusion device 100 when the occlusion device 100 is loaded onto the guidewire assembly 20. it can. In this embodiment, the outer surface of the supply guidewire 21 supports the occlusion device 100 and maintains the occlusion device in a ready state for deployment. In another embodiment shown in the figure, the support 70 includes an intermediate coil 70 that extends rearward from the position on the proximal end side of the protective coil 35 toward the bumper coil 60. As shown in FIG. 1, the intermediate coil 70 extends below the occlusion device 100 and over the supply guidewire 21. The intermediate coil 70 can be coextensive with one or more sections of the supply guidewire 21. For example, the intermediate coil 70 can extend with only the second section of the supply guidewire 21, or along a portion of both the third section 26 and the second section 24 of the supply guidewire 21. Can be extended.

  [43] The intermediate coil 70 guides an outwardly extending surface dimensioned to contact the inner surface of the occlusion device 100 to help support the occlusion device and maintain the occlusion device 100 ready for deployment. For wire assembly 20. As with the other coils described and illustrated herein, the intermediate coil 70 can be bent with the supply guidewire 21 as the supply guidewire 21 is advanced through the patient's vasculature due to its coil configuration. The intermediate coil 70 provides a constant diameter along the length of the supply guidewire 21 that is covered by the closure device 100, regardless of the taper of the supply guidewire 21 below the closure device 100. The intermediate coil 70 can taper the supply guidewire 21 so that the supply guidewire 21 follows the path of the vasculature without disturbing the support provided to the occlusion device 100. Therefore, the necessary flexibility can be obtained. The intermediate coil 70 provides constant support to the closure device 100 regardless of the taper of the supply guidewire 21 before the closure device 100 is deployed. Further, the minimum diameter of the closing device 100 in the compressed state is also controlled by the size of the intermediate coil 70. In addition, the diameter of the intermediate coil 70 may be selected so that an appropriate space (including no space) is formed between the occluding device 100 and the inner wall of the microcatheter 1 before the occluding device 100 is deployed. it can. The intermediate coil 70 can also be used to bias the occlusion device 100 away from the supply guidewire 21 during deployment of the occlusion device.

  [44] In any embodiment, support 70 may have an outer diameter D3 of about 0.010 inches to about 0.018 inches. In one embodiment, the outer diameter D3 is about 0.014 inch. The support 70 can also have a length L3 of about 2.0 cm to about 30 cm. In one embodiment, the length L3 of the support 70 is about 7 cm.

  [45] The occlusion device 100 may also be disposed on the intermediate coil 70 between a pair of optional marker bands that do not transmit radio positioned along the length of the guidewire assembly 20. Alternatively, the protective coil 35, the bumper coil 60, and / or the intermediate coil 70 can include a radio opaque marker. In other embodiments, the guidewire assembly 20 may include only one radio opaque marker. Through the use of a radio-opaque marker, the guidewire assembly 20 and the occlusion device 100 can be visualized while being placed in the vasculature. Such visualization techniques may include conventional methods such as fluoroscopy, radiography, ultrasonography, magnetic resonance imaging, and the like.

  [46] The occlusion device 100 can be supplied and deployed at the site of aneurysm A according to the following method and variations thereof. The supply of the occluding device 100 includes introducing the microcatheter 1 into the vasculature until the microcatheter 1 reaches the site requiring treatment. The microcatheter 1 is introduced into the vasculature using conventional techniques, such as being pushed over a conventional vascular guidewire (not shown) or simultaneously with the vascular guidewire. The positioning of the microcatheter 1 can be performed before the microcatheter receives the guidewire assembly 20 or while the microcatheter receives the guidewire assembly 20. The position of the microcatheter 1 within the vasculature can be determined by identifying a radio-opaque marker located on or within the microcatheter 1.

  [47] After the microcatheter 1 is positioned at the desired location, the guidewire is removed and the distal end of the introducer sheath 10 is inserted into the proximal end of the microcatheter 1 as shown in FIG. In one embodiment, the distal end of the introducer sheath 10 is introduced through the hub 2 at the proximal end of the microcatheter 1. The introduction sheath 10 is pushed into the microcatheter 1 until the distal end of the introduction sheath 10 is wedged in the microcatheter 1. In this position, the introduction sheath 10 cannot be pushed further into the microcatheter 1. Thereafter, the introducer sheath 10 is firmly held while the supply guidewire assembly 20 supporting the occlusion device 100 is pushed through the introducer sheath 10 until the occlusion device 100 is pushed out of the introducer sheath 10 and into the microcatheter 1. The

  [48] The guidewire assembly 20 and the occlusion device 100 are advanced through the microcatheter 1 until the tip coil 29 is closest to the tip of the microcatheter 1. At this point, the positions of the microcatheter 1 and the guide wire assembly 20 can be confirmed. Thereafter, the guidewire assembly 20 is pushed out of the microcatheter 1 and into the patient's vasculature so that the proximal end 107 of the occlusion device 100 is adjacent to the treatment area outside the distal end of the microcatheter 1. Is located. At any point during these steps, the position of the occlusion device 100 can be checked to determine that the occlusion device 100 will be deployed exactly at the desired location. This can be achieved by using the radio opaque marker described above.

  [49] When the distal end 102 of the occlusion device 100 is positioned outside the microcatheter 1, the proximal end 107 is shown in FIG. 7 within the vasculature while the distal end 102 remains covered by the protective coil 35. Start expanding in the direction of the arrow shown. When the occlusion device 100 is in the proper position, the supply guidewire 21 is rotated until the tip 102 of the occlusion device 100 moves away from the protective coil 35 and expands at a desired location within the vasculature (FIG. 8). The supply guidewire 21 can be rotated clockwise or counterclockwise as required to deploy the closure device 100. In one embodiment, the supply guidewire 21 may be rotated over 2-10 revolutions in either or both directions, for example. In other embodiments, the occlusion device may be deployed by rotating the supply guidewire 21 less than 5 revolutions, for example, 3-5 revolutions clockwise. After the occlusion device 100 is deployed, the delivery guidewire 21 can be drawn into the microcatheter 100 and removed from the body.

  [50] In an alternative or further deployment step shown in FIG. 9, the tip of the occlusion device 100 is separated from the protective coil 35 due to friction between the occlusion device 100 and the inner surface of the microcatheter 1. This friction can be formed by opening the occlusion device 100 and / or by biasing the occlusion device 100 toward the inner surface of the microcatheter 1 by the intermediate coil 70. Friction between the microcatheter 1 and the occlusion device 100 assists in the deployment of the occlusion device 100. If the occlusion device 100 does not open during deployment and does not move away from the protective coil 35, the supply guidewire 21 and the microcatheter 1 move relative to each other due to friction between the occlusion device 100 and the inner surface of the microcatheter 1. Therefore, the closing device 100 moves away from the protective coil 35. Thereafter, the supply guidewire 21 can be rotated to deploy the closure device 100 in the pipeline.

  [51] After the occlusion device 100 self-expands radially in order to occlude the neck of the aneurysm A and makes gentle but positive contact with the wall of the duct, the entire microcatheter 1 is removed from the patient's body May be. Alternatively, the microcatheter 1 may be left in place in the vasculature so that further instruments can be inserted or a drug can be applied in the vicinity of the treatment site.

  [52] Well-known materials can be used in the present invention. One common material that can be used with the occlusion device 100 and guidewire 21 is Nitinol, ie, it can be molded, annealed, deformed at low temperatures, and brought to its original shape by heating, such as when deployed at body temperature in the body. It is a nickel-titanium shape memory alloy that can be recovered. The radio opaque marker can be formed of a radio opaque material including a metal such as platinum or a doped plastic containing bismuth or tungsten to aid visualization.

  [53] The devices and methods described herein are not limited to deployment and use within the vasculature and may include any number of additional treatment applications. Other treatment sites can include body regions or sites such as body organs. Each variation of the above-described apparatus and methods for practicing the present invention, and variations of aspects of the present invention that are apparent to one skilled in the art are intended to be within the scope of the following claims. Nor are elements, components or method steps intended to be dedicated to the public, whether or not they are explicitly recited in the claims.

2 is a cross section of an occluding device and an occluding device supply assembly in accordance with an aspect of the present invention. 2 shows the introducer sheath and catheter shown in FIG. FIG. 3 is a partial cross-sectional view of the introducer sheath of FIG. 2 supporting a guidewire assembly loaded with an occlusion device. FIG. 4 is a cross section of the guidewire assembly shown in FIG. 3. FIG. 5 is a schematic view of the guidewire assembly of FIG. 4. FIG. 5 is a second schematic view of the guidewire assembly of FIG. 4. A portion of the guidewire assembly located outside the catheter and the occlusion device are shown and how the proximal end of the occlusion device begins to deploy in the conduit. Fig. 4 illustrates one step in the method of deploying the occlusion device. Fig. 4 illustrates the deployment of a closure device according to one aspect of the present invention. FIG. 6 is a schematic view of a guidewire assembly according to another embodiment of the present invention. FIG. 11 is a schematic view of the deployed occlusion device after it has been deployed by the guidewire assembly of FIG. 10.

Claims (20)

A system for supporting and deploying an occluding device,
A sheath and an assembly configured to support the occlusion device;
The assembly includes an elongate flexible member including an occlusion device retaining member that receives a first end of the occlusion device;
The long flexible member is applied by a rotational force applied to a proximal end side of the long flexible member so that the closing member holding member rotates relative to the sheath around an axis extending in the longitudinal direction of the flexible member. A system configured to be rotatable to deploy the closure device from   The system of claim 1, wherein the elongate flexible member includes a guidewire having a flexible atraumatic tip.   The system of claim 2, wherein the guidewire is movable longitudinally relative to the sheath.   The system of claim 2, wherein the guidewire has at least two sections having different diameters.   The system of claim 2, wherein the guidewire has sections of different bends.   The occlusion device holding member includes an inner recess for receiving and holding the first end of the occlusion device before deployment of the occlusion device by rotation of the elongated flexible member, and the occlusion device holding member The system of claim 1, wherein the system is secured to the flexible member.   A holding member located on the base end side configured to engage with the second end of the closure device is further provided, and the holding member located on the base end side attaches the closure device to the flexible member. The system of claim 1, comprising a biasing member biasing toward the tip.   The system according to claim 7, wherein the proximally located holding member includes a portion of the flexible member.   The system of claim 1, further comprising a catheter, wherein the assembly and the occlusion device are located within the catheter.   The system of claim 1, wherein the occlusion device retaining member includes a portion configured to protect the first end of the occlusion device.   The system of claim 1, wherein the occlusion device is a stent.   The system of claim 11, wherein the stent is a woven permeable stent.   The system of claim 11, wherein the stent is a self-expanding stent.   The system of claim 1, further comprising a support having an outer surface extending along a portion of the flexible member and configured to engage an inner surface of the occlusion device.   The system of claim 14, wherein the support surrounds a portion of the flexible member.   The system of claim 14, wherein the support comprises an elongate coil.   The system of claim 14, wherein the occlusion device is movable relative to the support.   The system of claim 14, wherein the occlusion device retaining member has an outer surface that extends further from the outer surface of the flexible member than the outer surface of the support.   The system of claim 1, wherein the closure device retaining member comprises a protective coil.   The system of claim 19, wherein the protection coil receives a first end of the occlusion device within the protection coil.

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