Vascular occlusion device

Abstract

This invention provides an occlusion device that can conform to the complex shape of the vascular system and can quickly occlude the target area. [Solution] An occlusion device comprising: a support having a first passage, the support comprising a woven mesh structure having a first radius, the mesh structure ending with a base member having a second radius smaller than the first radius; and a retaining portion comprising a central element and a plurality of loops connected to the central element, the central element being connected to the base member, wherein the support or the central element is configured to be detachably connected to at least one of a microcatheter or a pressure device.

Description

Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 62 / 293,710, filed February 10, 2016, entitled "Device for Vascular Occlusion", the entire contents of which are hereby incorporated by reference. BACKGROUND OF THE INVENTION

[0002] Vascular occlusion is often necessary in a variety of cases including, but not limited to, treatment of aneurysms, atrial septal defects, patent foramen ovale, left atrial appendage occlusion, patent ductus arteriosus, fistulas, arteriovenous malformations, fallopian tube occlusion for infertility, and occlusion of the peripheral vascular system. One method of vascular occlusion involves filling a blood vessel, malformation, or aneurysm with an occlusion device for embolization purposes. Typically, embolization coils are used for this purpose.

[0003] Due to the complex arrangements potentially associated with various target regions of the vascular system, it is difficult to achieve successful occlusion. Therefore, there is a need for an occlusion device that can conform to the complex shapes associated with the vascular system and quickly occlude the target region. SUMMARY OF THE INVENTION

[0004] An occlusion device is described below.

[0005] In one embodiment, the occlusion device includes a retaining portion and a supporting portion. In one embodiment, the retaining portion is in a clover shape and the supporting portion on the tip side is a cylindrical mesh.

[0006] In one embodiment, the occlusion device includes a retaining portion and a supporting portion, and other occlusion devices can be used to fill the supporting portion.

[0007] In one embodiment, the occlusion device includes a holding portion, a support portion, and an attached transport tube, wherein an additional occlusion device is transportable via the attached transport tube to fill the support portion.

[0008] In one embodiment, the occlusion device includes one or more disc-shaped elements.

[0009] In one embodiment, the occlusion device includes one or more disc-shaped elements and a central element that traverses at least some of the disc-shaped elements.

[0010] In one embodiment, the occlusion device includes a ribbon shape. In one embodiment, the occlusion device includes a helical ribbon shape.

[0011] In one embodiment, the occlusion device includes a small-diameter region and a large-diameter region. In one embodiment, these small-diameter and large-diameter regions are alternately continuous. In one embodiment, the small-diameter region utilizes one substantially constant shape, and the large-diameter region utilizes one different substantially constant shape.

[0012] In one embodiment, a transport system for transporting and removing an occlusion device is described.

[0013] In one embodiment, the occlusion device utilizes an expansion / contraction resistance member to assist in controlling the expansion of the occlusion device during transport.

[0014] In one embodiment, the occlusion device includes an outer member and an inner member. In one embodiment, the inner member and the outer member are made of the same braided material that is filled inside each other.

[0015] In one embodiment, the occlusion device includes one or more sealing members, the sealing members of which may be positioned on at least one of the proximal and / or tip ends of the device.

[0016] In one different embodiment, the occlusion device includes a structural portion and a mesh or membrane portion that covers the structural portion.

[0017] In one different embodiment, the occlusion device includes a cervical bridge element and one or more filling structures.

[0018] In one different embodiment, the occlusion device includes a cervical bridge element and an embolic material such as an embolizing coil.

[0019] In one different embodiment, the occlusion device includes a plurality of structural supports and an end contact portion.

[0020] In one different embodiment, the occlusion device includes two separate occlusion sections connected by a coil.

[0021] Furthermore, a method for manufacturing an occlusion device is described.

[0022] In one embodiment, the occlusion device is manufactured by taking a central element and attaching one or more wires to the central element to form a retaining portion. In one embodiment, the shape of this retaining portion is clover-shaped. A support portion, i.e., a mesh containing multiple wires in one embodiment, can then be attached to the retaining portion.

[0023] In one embodiment, the occlusion device is manufactured by winding the occlusion device so as to cover one or more disk-shaped elements. The one or more disk-shaped elements have a plurality of holes through which the constituent wires of the occlusion device are inserted and wound. The one or more disk-shaped elements may optionally include a central channel through which a plurality of wires are drawn to form a central element that traverses at least some of the disk-shaped elements.

[0024] In a different embodiment, the occlusion device is manufactured by thermally curing a device that covers a mandrel into a shape including a small-diameter region and a large-diameter region. In a different embodiment, the occlusion device is manufactured to cover a mandrel having a relatively constant diameter. Thereafter, a plurality of marker bands or a plurality of coupling elements are selectively disposed across the entire occlusion device to form a small-diameter region that covers all of the length of the occlusion device.

[0025] In a different embodiment, a braider uses both an inner braider and an outer braider to braid the occlusion device. The occlusion device is wound to cover one or more mandrels, and the use of both the inner braider and the outer braider can assist in speeding up the manufacturing process.

[0026] In a different embodiment, a tapered mandrel can be used with a braider to form an occlusion device that includes both an inner region and an outer region.

[0027] In a different embodiment, a removable mandrel can be used to wind the occlusion device.

[0028] In a different embodiment, a vertical braider is described. The vertical braider can be used to manufacture the occlusion device.

[0029] In one different embodiment, an implant including a closed end is braided to cover a mandrel that utilizes the closed end and a series of pins on the closed end section, assisting in the formation of the closed end. The implant may be an occlusion device.

[0030] In one different embodiment, a rotatable bider is described. The rotatable bider can be used to form an implant having a plurality of regions with different rigidities.

Brief Description of the Drawings

[0031] These and other aspects, features, and advantages of the embodiments of the present invention that can be implemented will become apparent and will be described from the following description of the embodiments of the present invention and reference to the accompanying drawings.

[0032] [Figure 1-5] Figures 1-5 show an occlusion device including a holding portion and a supporting portion.

[0033] [Figure 6] Figure 6 shows an occlusion device including a plurality of holding portions.

[0034] [Figure 7] Figure 7 shows a manufacturing element used to form the holding portion of an occlusion device. <00^0116> [Figure 8-12] Figures 8-12 show an occlusion device including a plurality of disc-shaped portions and a mandrel for creating the same.

[0036] [Figure 13-14] Figures 13-14 show an occlusion device including a small-diameter region and a large-diameter region.

[0037] [Figure 15] Figure 15 shows an occlusion device including a spiral ribbon.

[0038] [Figure 16-22] Figure 16-22 shows various removal systems for implants, where the implant may be an occluding device.

[0039] [Figure 23] Figures 23A and 23B show an occlusion device having a tension member that allows the device to expand in a curved configuration.

[0040] [Figure 24] Figures 24A and 24B disclose an occlusion device extending from its own catheter in an offset configuration.

[0041] Figure 24C shows the mandrel for forming the occlusion device shown in Figures 24A and 24B.

[0042] [Figure 25] Figures 25A-25D show a braided occlusion device having multiple concave end points and a mandrel for creating them.

[0043] [Figure 26] Figures 26A-26F show the occlusion device, including the outer section and the inner section.

[0044] [Figure 27] Figures 27A-27D show a closure device including a sealing member.

[0045] Figures 27E-27F show an occlusion device that includes a structural portion and a mesh or membrane portion.

[0046] [Figure 28] Figures 28A-28C show a brider including an inner brider and an outer brider. The brider can be used to braid an occlusion device.

[0047] [Figure 29] Figures 29A-29E show tapered mandrels used to form occlusion devices.

[0048] [Figure 30] Figure 30 shows a vertical brider.

[0049] [Figure 31] Figures 31A and 31E show mandrels used to form implants with closed ends.

[0050] Figures 31B-31D and 31F show alternative embodiments of the occlusion device having a braided closing end.

[0051] [Figure 32] Figures 32A-32C show the intersecting sections of the braided structure formed by the rotatable bridles.

[0052] [Figure 33] Figures 33A-33E show the removal system used in conjunction with the occlusion device.

[0053] [Figure 34] Figures 34A-34B show the removal system used in conjunction with the occlusion device.

[0054] [Figure 35-40] Figure 35-40 shows an occlusion device including a cervical bridge element.

[0055] [Figure 41-42] Figures 41-42 show a closure device that includes multiple support columns and a tip contact portion.

[0056] [Figure 43-45]Figures 43-45 show a closure device including the top element, the bottom element, and the coil connection component. [Modes for carrying out the invention]

[0057] Several specific embodiments of the present invention are described with reference to the accompanying drawings. However, the present invention can be carried out in several different forms and is not intended to be limited to the embodiments described herein, but rather these embodiments are provided so as to make this disclosure detailed and complete and to fully convey the scope of the invention to those skilled in the art. The technical terms used in the detailed description of the several embodiments shown in the accompanying drawings are not intended to limit the invention. In the drawings, similar numbers refer to similar elements.

[0058] Devices for occlusion and / or embolization are described. These devices can be used for a variety of purposes, but are not limited to, filling aneurysms, atrial septal defects, patent foramen ovale, left atrial appendage occlusion, patent ductus arteriosus, fistulas, arteriovenous malformations, fallopian tube occlusion for infertility, and occlusion of the peripheral vascular system. Some of the embodiments described herein can be considered intrasaccular devices.

[0059] For the purpose of illustrating the use of the various embodiments described herein, a treatment of aneurysms is described for simplicity and consistency. However, various embodiments of this device can be used for numerous purposes, including those described above, in addition to the treatment of aneurysms.

[0060] Typical techniques for treating vascular diseases such as aneurysms utilize coils to fill the space or clips to block blood flow to the target area. These techniques are challenging because coil placement and retention can be problematic when the aneurysm / treatment area has a wide neck or complex shape. Intracapsular devices aim to create an occlusion in the neck of the aneurysm and further conform their shape to the general shape of the aneurysm, thereby restricting blood flow from the neck to the aneurysm and occluding the target site. An example of such a device can be found in US20140200607 by the same applicant, the entire disclosure herein is incorporated by reference.

[0061] Furthermore, the intracapsular devices described herein may be used in conjunction with embolic coils, liquid embolic materials, or other embolic means to enhance the occlusive effect at the target site. Many embodiments disclosed herein are removable intracapsular devices connected to a catheter, and which allow the embolic material to be delivered via the catheter. The catheter has a path that extends along its longitudinal direction and opens into the intracapsular device. As the intracapsular device is advanced toward the target aneurysm and expands, the embolic means, such as embolic coils or liquid embolic materials, is advanced through the catheter and exits from the catheter into the intracapsular device and / or aneurysm. Finally, the intracapsular device can be removed from the catheter. Alternatively, the intracapsular device can be placed in the aneurysm first to occlude it from adjacent vessels, and then the embolic material can be delivered. This order of procedure allows for better retention of the embolic material within the aneurysm compared to delivering the embolic material first and then the intracapsular device. Furthermore, the opening within the intracapsular device may also be used to attach a tether (connecting net) or monofilament connected to the catheter, thereby allowing the intracapsular device to be removed from within the catheter using a removal mechanism.

[0062] One embodiment of such an intracapsular device 11 can be seen in Figure 1-5. The intracapsular device 11 includes a plurality of support sections 12 for supporting a plurality of embolization coils 6, and a retaining section 10 that expands and supports the proximal ends of the support sections 12. As will be described in more detail below, the intracapsular device 11 has an opening connected to a pathway within the microcatheter 9, and allows for the expansion of a tether for detachably holding the intracapsular device 11 and / or the transport of the embolization material after connection.

[0063] In one embodiment, the support portion 12 is composed of multiple wires woven together to form a mesh or braided structure, and further extends into a cylindrical or concave disc shape. As best shown in Figures 4A and 4B, the base end of the support portion 12 is terminated with its own mesh, together with a cylindrical base end member 15. This end member 15 preferably includes a path 15A (see Figure 4B) connecting the base end and the tip end of the support portion 12.

[0064] In one embodiment, the base member 15 can be formed by first gathering the base ends of the mesh of the support portion 12, and then arranging a relatively large radiopaque marker band around the base ends of the gathered mesh. Next, a smaller marker band is lined up inside the mesh and aligned concentrically with the larger marker band. Finally, the two marker bands are welded together. Since both marker bands are annular or ring-shaped, the two marker bands together form a base member 15 having a path 15A through which both marker bands are inserted.

[0065] In one different embodiment, the base member 15 can be formed by feeding all of the braided wires of the support mesh through the center of an X-ray opaque marker band. A mandrel with low welding capacity (i.e., a mandrel that does not easily melt at normal welding temperatures) is placed within the mesh and marker band, and the mesh and ring are welded together, leaving a path 15A through which the resulting base member 15 is inserted.

[0066] In yet another embodiment, the base end member 15 can be formed by arranging multiple braided wires of the support portion mesh to be inserted into a tube having low weldability. A mandrel, also having low weldability, is inserted inside the mesh, allowing multiple wires of the mesh to be welded together. The tube and mandrel are removed from the mesh, leaving a path 15A through which the resulting base end member 15 is inserted. Optionally, additional welding can be performed around the outer diameter of the device to increase the strength of the end member 15.

[0067] In one different embodiment, the size of the base end member 15 can be reduced by first cutting the base end of the initial braided structure of the support portion 12 so that it becomes a plurality of pointed or triangular flaps 12A. For example, four to sixteen flaps can be formed. In one of the techniques described above, the resulting plurality of flaps 12A can be brought together more closely to form the base end member 15. The reduction in the number of wires held together in the end member 15 makes it possible to obtain an end member 15 that is substantially smaller than when multiple flaps 12A are not formed.

[0068] In one embodiment, the retaining portion 10 comprises a plurality of loops 22 formed from one or more wires, and further extends radially such that the plurality of loops 22 are substantially aligned in a single plane. The retaining portion 10 comprises a central element 18, shown in the top and side views of Figures 3 and 4, which holds a plurality of wires forming the plurality of loops 22. The central element comprises a central opening or lumen 21 and a plurality of smaller openings 20. The central opening 21 is preferably connected to or aligned with the path 15A of the support portion 12, thereby forming a continuous path between the path in the catheter 9, the path 15A, and the opening 21. This continuous path allows the embolic material to be delivered into the intracapsular device 11.

[0069] Multiple wires are inserted through multiple small openings 20 to form a clover shape as shown in Figure 5. Four of these “clover leaf” loops 22 are shown in Figure 5, but fewer or more leaves may be used. In one embodiment, each leaf can be formed by a single wire, with one end of the wire positioned to insert through a first hole and the other end of the wire positioned to insert through a second hole. The two ends of the wire are joined to each other by welding or other means. Thus, each leaf utilizes two holes on the central element 18. Figures 3-4 show eight holes used with each of the four leaves. In one different embodiment, the central element may not contain holes and instead may be simply a single component to which the clover leaf wires are attached (by adhesive, mechanical bonding, or welding).

[0070] Figure 7 shows a mandrel or fixture 17 that can be used to form the retaining portion 10. The fixture 17 has a slot 17A for housing the central element 18. Multiple wires can be wound around the “petal”-shaped fixture 17B to form multiple “cloverleaf” loops 22. Optionally, a press 17C may be used to press the device downward and maintain its shape. In addition, optionally, a heat treatment procedure may be performed thereafter.

[0071] The support element 12 can be attached to the holding portion 10 by adhesive, mechanical bonding, or welding. The support element 12 is positioned to traverse the base-end opposing portions of a plurality of “cloverleaf” loops 22, and then extends like a cylinder with a wall portion projecting toward the tip. The support element 12 as shown in Figure 1 has an open top, but a closed top may also be used. The support element 12 can be constructed from a wire mesh or braided structure such as nitinol wire. Alternatively, radiopaque materials such as titanium, platinum, gold, and / or palladium may be used. In one embodiment, the mesh simply comprises nitinol wire. In another embodiment, the mesh comprises nitinol wire together with another radiopaque wire (e.g., the materials mentioned above). In another embodiment, a wire comprising a radiopaque core and a nitinol outer layer, or a nitinol core and a radiopaque outer layer may be used. As best shown in Figure 2, in one embodiment, the retaining portion 10 is positioned at the neck of the aneurysm, while the support element 12 is located inside the aneurysm and fills it.

[0072] The device 11 in Figure 1 can be placed inside a relatively large transport catheter 8, to which the device 11 itself is connected to a relatively small microcatheter 9. The microcatheter 9 either follows a path through the relatively large catheter 8 or is pre-positioned within the tip of the transport catheter 8. The base end of the support portion 12 of the device 11 may be coplanar with the central element 18 of the holding portion 10, extend close to the holding portion 10, or terminate approximately coplanar with the rear or all of the multiple "cloverleaf" loops 22. In one different embodiment, the wire portions of the multiple cloverleaf loops 22 are located below the central element 18 because they pass through the opening 20 of the central element 18 (see Figure 3). This forms a cage shape (in the shape of Figure 5, the four loops form four wire cage protrusions), and the base end of the mesh support portion 12 is located inside this cage and constrained by the wires of this cage. Alternatively, the wires of the support section 12 can be directly attached above or below the multiple cloverleaf loops 22 by adhesive, mechanical bonding, or welding. If this technique is used, the mesh will be configured so as not to block the central opening 21 of the central element 18. The lumen must not be blocked, as it can be used to deliver additional embolic material, as described below.

[0073] In one embodiment, the occlusion device 11 shown in Figure 1 is attached to a microcatheter 9. Specifically, the microcatheter 9 is connected at its tip to a central element 18, a support portion 12, and a retaining portion 10. The microcatheter 9 is transported via a relatively large catheter 8, and the support portion 12 and retaining portion 10 are folded when within this larger catheter 8. In this folded configuration, the clover-leaf loops 22 of the retaining portion are pressed together (similar to a bud before blooming) and positioned beyond the tip of the microcatheter. The support portion is then positioned further forward and similarly folded. The relatively large transport catheter 8 is retracted to expose the microcatheter 9 and the attached occlusion device 11. Alternatively, the microcatheter 9 is pushed out from the tip of the transport catheter 8 to expose the device. Once exposed, the support portion and retaining portion assume an expanded configuration as shown in Figure 1. After the occlusion device 11 is positioned within the target treatment site 14, the lumen of the microcatheter 9 can be used to deliver additional embolic material, such as the embolic coil 6 or liquid embolic material, as best shown in Figure 2.

[0074] One different embodiment uses only the retaining portion 10 and omits the support portion 12. In such an embodiment, the retaining portion is used alone to prevent the subsequently transported embolizing coil from falling outward from the neck of the aneurysm 14. Another different embodiment may use a retaining portion 10 having a mesh layer positioned above, below, or on both sides of the multiple “cloverleaf” loops 22 of the retaining portion 10. The mesh provides an occluding effect that restricts the flow of blood into the aneurysm (i.e., the mesh itself provides a barrier against blood intrusion). Any additional subsequently introduced embolizing material, such as an embolizing coil or liquid embolizing material, will then augment the occlusion within the aneurysm / treatment site. For example, after the occlusion device 11 is positioned at the target treatment site and any selective embolizing material (i.e., a coil, liquid embolizing material, or other embolizing material) is introduced via the microcatheter 9, the occlusion device 11 is removed from the microcatheter and remains at the treatment site. This allows the microcatheter 9 to be withdrawn.

[0075] A removal system can be used in conjunction with the central element 18 of the retaining element 10. Several removable tip devices for removing the tip section of a microcatheter are known in the art, and these are often used in conjunction with liquid embolization material delivery systems, and are removable so that the rest of the catheter can be withdrawn if the tip section of the catheter becomes stuck or "adhered" to the delivered liquid embolization material. A removable tip can be used in conjunction with the central element 18, so that the microcatheter has a central element 16 and a retaining element 10 built on the tip end of the microcatheter. An electrolytic, thermal, or mechanical removal system can be used to separate the central element from the microcatheter and leave the occlusion device at the target treatment site. Alternatively, the removal contact may be located proximal to the central element. For example, the removable tip element may be connected to the central element 16 but located in close proximity to the central element. U.S. Patent Publication No. 2015 / 0137773 discloses several detachable tip system embodiments available in this embodiment, and all disclosures of U.S. Patent Publication No. 2015 / 0137773 are incorporated herein by reference.

[0076] Figures 33A–33E show a unique removal system 107 that can be used with the occlusion device 11 shown in Figure 1, as well as any of the other occlusion devices described herein. Unlike other removal systems in the prior art, the embodiments in Figures 33A–33E show a removal system capable of accommodating the central opening of the lumen 21 (most preferably shown in Figure 3). One of several embodiments of the device 107 utilizes an occlusion device connected to the tip of a relatively small microcatheter or transport tube 106. In this case, the device 107 itself is transported via another relatively large catheter. The removal system 107 allows the microcatheter or transport tube 106 connected to the occlusion device 11 to be removed from the occlusion device 11 at an appropriate time. For example, the occlusion device 11 is placed in an aneurysm, the attached microcatheter 106 is used to transport additional embolic material (e.g., liquid embolic material or coil), and then the microcatheter 106 is removed and detached, resulting in the occlusion device 11 being left in place. The removal system 107 utilizes a heater 104 located in the tip-side region of the attached microcatheter 106. The heater 104 is an electrical resistance wire coil or laser-cut sheet in various patterns (e.g., a rectangular wave pattern as shown in the drawings). Wires 108a and 108b are connected to the heater 104 at two points and are supplied from a voltage source at the proximal end of the device 107, so that each wire is polarized in opposite directions, thereby enabling the heater 104 to carry current. A cylindrical cover 110 is positioned to cover the heater 104, and a sacrificial polymer layer or adhesive layer may be located between the cover 110 and the heater 104. The operating principle is that the heat generated by the heater 104 separates the sacrificial layer and removes the microcatheter 106 from the cover 110, thereby leaving the microcatheter in place without retracting it from the vascular structure, as shown in Figures 33D and 33E.

[0077] Figure 33A shows a configuration in which both the sacrificial polymer or adhesive layer and the heater are stretched to surround an opening or lumen at an angle greater than 180 degrees but less than 360 degrees. Various configurations are possible. For example, the inner sacrificial polymer or adhesive layer melted by the heater may be stretched in discontinuous segments that selectively cover the circumferential surface of the opening. The heater and sacrificial layer may be stretched to surround the opening completely 360 degrees or nearly 360 degrees. One of the heater or sacrificial layer may be stretched to surround the opening completely 360 degrees, while the other stretches to surround the opening by less than 360 degrees. Preferably, the sacrificial layer is stretched to surround the opening by at least 180 degrees, while the heater must at least cover the width of the sacrificial layer.

[0078] The operation method using the occlusion device 11 in Figure 1 and the removal system 107 in Figures 33A-33E includes the steps of taking the occlusion device 11 together with the attached microcatheter 106 and transporting the system via a relatively large catheter. Once the occlusion device 11 is properly positioned, additional embolic material is optionally transported via the attached microcatheter 106, after which the removal sequence is initiated, the microcatheter 106 is removed from the occlusion device 11, and subsequently the microcatheter 106 is withdrawn.

[0079] Figures 34A and 34B show a occlusion device removal system 150 that can be used with the occlusion device 11, as well as any of the other occlusion devices described herein. As shown in Figure 34B, the system 150 uses a device coupling ring 152 on the proximal end of the occlusion device and two tethers 159 attached to a tubular pressing body 156. Each tether 158 is connected to a selectively activated power source and, when activated, is surrounded by a heater coil 158 that raises the temperature and further destroys the tether 159, removing the device coupling ring 152 and the occlusion device connected thereto.

[0080] The heater coil 158 is preferably located within two opposing channels cut into a tubular pressing body 156. The paths within the heater coil 158 are each arranged in line with the opening 154A via a pressing coupling ring 154. Similarly, the device coupling ring 152 has two openings 152A that are opposite or on opposite sides to each other and arranged in line with the opening 154A. The tether 159 is inserted through the opening 152A and coupled or fixed to the proximal end of the opening 152A via the opening 154A and the heater coil 158, and is further coupled / fixed proximal to the heater coil 158 and inside the slot 156A.

[0081] If the occlusion device, like device 11, comprises a braided structure or mesh, the occlusion device is first attached to the device-connecting ring 152 by feeding the mesh through the main opening of the ring 152, and then positioning an inner mandrel, matched to the size of the central lumen of the compression tube 156, within the center of the captured mesh. The ends of the mesh are then welded to the ring 152 and the mandrel is removed, thereby leaving a pathway within the occlusion device. The main opening of the compression-connecting ring 154 is sized and positioned to cover the end of the compression tube 156, so that the central lumen of the compression tube 156 aligns with the pathway formed by the device-connecting ring 152 and the mesh of the occlusion device. This allows the embolic material to advance through the central compression lumen and the occlusion device before the occlusion device is removed.

[0082] As shown in Figure 6, multiple retaining portions 10 are available. The retaining portion 13b closer to the proximal end is positioned at the neck of the aneurysm, and the retaining portion 13a closer to the distal end is positioned inside the aneurysm. This embodiment can also be used with the support element 12 shown in Figure 1, with the retaining portion 10b closer to the distal end being positioned at the proximal end of the support element 12. Removal of the retaining portion 13b is performed using the heating technique described above.

[0083] Figures 8-12 illustrate several embodiments of an occlusion device comprising a braided structure that forms multiple disc-shaped sections 31, such as the device 30a in Figure 9, which has four disc shapes. Although the term “disc-shaped” is used, the formed sections may take on numerous shapes, such as elliptical, oval, cylindrical, conical, or frustoconical. The purpose of such shapes is to take into account both the compressibility and extensibility of the occlusion device.

[0084] This shape is formed by a plurality of wound mandrels 26 having the shape of the desired braided section 31. Figure 8 shows one embodiment of two disc-shaped mandrels 26 connected to each other by a support 24 that is inserted and extended. Each mandrel 26 has a plurality of holes 28 into which pins 23 can be inserted to form the desired braided pattern. A portion of the pins 23 are located outside the holes 29, and the braided structure can be wound around various pins to form a closure device shape. Each mandrel 26 may have the same shape, each mandrel 26 may have a different shape, and a combination or similar / different shapes may be used for the plurality of mandrels 26.

[0085] Figure 10 shows an embodiment of a closure device 33, similar to the device 30a in Figure 9, but with a central braiding element 32. The molded mandrel 26 in Figure 8 is equipped with a central support 24. The top of the closure device is formed by winding multiple wires through the upper mandrel, and the remaining portions of the multiple wires are drawn out from the bottom of the central element and central support 24. Alternatively, if the central element 24 is a rod and does not have a lumen, the remaining portions of the multiple wires are drawn out to surround the central element 24 and not through it. Alternatively, the multiple constituent wires are first drawn out to pass through or surround the central rod 24, and then winding of the mandrel is initiated. Various winding techniques are available. For example, when three disc-shaped elements 31 are used as shown in Figure 10, the process begins by first winding around the central mandrel 26, then the lower mandrel 26, then pulling the multiple wires back over to cover the multiple mandrels, and then winding the multiple wires to cover the upper mandrel 26. This results in multiple wires being pulled back to cover the device, so that the sidewalls become double, covering a portion of the mesh device, and a multilayer effect can be obtained. Figures 9-12 show a closure device containing three-four molded sections 31, but fewer or more molded sections 31 can be used.

[0086] Multiple other closure device shapes may utilize the central element in all, not just a portion, of the braided structure. Various closure shapes are possible using fewer or more disc-shaped elements. Figure 11 shows different shapes of elements 31 of different shapes and different shapes of closure devices 35 that utilize the central element through which only a portion of the closure device is inserted. In one embodiment, the base ends of multiple wires are welded or attached to the base end of the central element 32 so that the base ends of the closure device are integrated.

[0087] Figure 12 shows the device 33 from Figure 10 within the aneurysm 14. As mentioned above, one advantage of using a mesh and having multiple disc-shaped elements of different shapes lies in the compressibility and extensibility of the braided structure. The braided structure is extensible, and furthermore, the radial dimensions of the disc elements can be reduced, and it is also rapidly compressible and expandable at the expense of elongation in the longitudinal direction.

[0088] In one embodiment, a winding method for winding the closure device of Figure 8-12 is described and shown in Figures 28A-28E. The winding method is useful for forming a device similar to the device shown in Figure 10-12, which utilizes a central braiding element 32 inside the disk portion 31. The winding process utilizes two braiding mechanisms, namely an outer brider 84 and an inner brider 86. A first set of wires 80 is connected to the outer brider 84, and these wires 80 are wound so as to cover several pins of the mandrel 26A. A second set of wires 82 is connected to the inner brider 86, and these wires are not braided to cover several pins, but instead are drawn into the central channel of the mandrel (i.e., element 24 in Figure 8). The several wires 82 are then positioned on the outer brider 84.

[0089] The second mandrel 26B is positioned next to the first mandrel 26A. A first set of wire 80 is drawn out to pass through the inner channel of the second mandrel 26b (similar to how wire 82 was initially drawn out to pass through the inner channel of the first mandrel 26a), while a second set of wire 82 is wound to cover several pins of the second mandrel. The first set of wire 80 is connected to the inner brider. As is easily understood, once the set of wire is drawn out to pass through the inner channel of the mandrel, this wire is connected to the inner brider, while once the set of wire is wound to cover several pins of the mandrel, this wire is connected to the outer brider. The brider has a number of carriers 86, each containing a number of bobbins for housing wire. The brider is automated so that the carriers rotate in various configurations while the mandrel moves in the longitudinal direction, enabling the braiding to be performed. Additional mandrels may be placed, and the wire arrangement is performed in a continuous, alternating manner. For example, a first set of wires 80 may first form an outer braided structure surrounding the first mandrel, then an inner braided structure within the second mandrel, and then an outer braided structure around the third mandrel, while a second set of wires 82 may form an inner braided structure around the first mandrel, then an outer braided structure around the second mandrel, and then an inner braided structure around the third mandrel. Since multiple different wire elements form multiple different parts of the outer braided structure and multiple different locations of the outer braided structure, the inner braided structure 32 of this described winding method can be considered discontinuous.In some places, all the wires (both wire sets 80 and 82) need to be held by the outer brider, so the outer braided structure requires more carriers to hold various wires, while the inner brider only needs to hold wire sets 80 and 82 (or neither), so the outer brider 84 will require at least twice the number of carriers as the inner brider 86. For example, if the braided structure for each section consists of 48 wires (i.e., each wire set 80 and 82 contains 48 wires, for a total of 96 wires used), the inner brider must have at least 48 carriers to house one of the wire sets, while the outer brider must have at least 96 carriers to house both of the wire sets.

[0090] Figures 28A-28C illustrate the various manufacturing processes described above. Multiple different winding methods may also be used, utilizing the continuous inner elements 32. For example, a second set of wire 82 may be pulled up to pass through the inner channels of a series of mandrels, while a first set of wire 80 may be wound around the circumferential surfaces of various mandrels. When the inner and outer briders are used in this configuration, the second set of wire 82, including the continuous inner elements 32, remains connected to the inner blider during the braiding operation, while the first set of wire 80, including the outer braiding portion, remains connected to the outer brider.

[0091] Figures 29A-29E show another method for forming a braided structure having multiple layers. A tapered mandrel 88 is braided by a brider 90. The taper allows one end to have a smaller diameter and the other end to have a larger diameter, with the diameter changing between the two ends. For reasons described below, it is desirable that a portion of the small-diameter end 88a has a constant diameter, as shown in Figure 29C. The tapered mandrel is braided. Circular elements 92 can be placed at one or more locations along the small-diameter portion 88a of the tapered mandrel, where the diameter is constant. The rest of the braided structure is then folded over the circular elements forming an outer spherical shape, while portion 88a remains as is, containing the inner braided portion. In Figure 29E, three circular elements are placed along section 88a to form three enlarged sections. To set the shape, the folded sections can be joined and heat-cured.

[0092] Figures 13A and 13B show an occlusion device 37 that includes a tubular braided structure which is flattened into a double layer and then thermoformed to form a series of narrow mesh regions 39 and wide regions 30b (i.e., multiple “petal” shapes 30b). These petal shapes 30b are thermoformed twice to achieve a curved shape that roughly matches the curvature inside the aneurysm.

[0093] When the initial tubular braided structure is woven with a uniform braiding pattern, the braiding density is highest in the narrow region 39 and lowest in the center of each petal 30b. However, the center of the petal 30b is where the device 37 attempts to create the greatest flow obstruction within the aneurysm, and such a braiding density does not optimally obstruct the flow as intended. Figure 14 shows a braiding technique and pattern in which both the pitch and width of the braided structure vary, thereby providing a region 41 with increased braiding density in the center of the petal 30b and a region 43 with decreased braiding density between the centers of multiple petals 30b. This variable pitch / width technique allows for optimization of the braiding density for the most effective flow obstruction where the petal width is greatest and where it is most needed.

[0094] The braiding fixture 35A can be used to form a variable pitch / width of the braided structure. The fixture 35A is a valve structure whose diameter increases and decreases regularly, forming a repeating three-dimensional wave pattern. The fixture 35A also has numerous mounting points for multiple pins 35B that are arranged at regular intervals around the fixture 35A, allowing one or more wires to be braided around the fixture 35A. The longitudinal spacing of each pin 35B is minimum at each peak of the "wave" in region 41, gradually increases as it approaches the trough of the wave in region 43, and then increases again as it approaches the peak of the wave. The pore size of the braided pattern is minimum at each peak of the "wave" and maximum in the trough of the "wave".

[0095] Figure 15 shows a occlusion device 34 including a helical ribbon mesh. The helical ribbon may have a uniform or variable diameter / thickness. The support element 12 in Figure 1 and the occlusion devices in Figures 9-15 utilize a wire braided structure or mesh. Multiple wires can be made from nitinol, cobalt-chromium, polymers, stainless steel, and / or spring-tempered stainless steel. Alternatively, radiopaque materials such as tantalum, palladium, gold, and / or palladium may be used and incorporated into the mesh together with the radiopaque materials listed in the preceding paragraph. In one embodiment, the mesh may consist only of nitinol wires, and in another embodiment, the mesh may consist of a mesh of nitinol wires together with other radiopaque wires (of the materials described above) that contain the mesh. In another embodiment, a wire consisting of a radiopaque core and a nitinol outer layer, or a wire consisting of a radiopaque core and a nitinol outer layer, may be used. In one embodiment, the wire diameter may be approximately 0.002” to approximately 0.005”. Additionally, to aid visualization, some or all of the wires containing the braided structure / mesh may include radiopaque (i.e., tantalum) coils.

[0096] The device 11 in Figure 1 may utilize a removable tip type system as already described, since the occlusion device in this figure is attached to the tip of a microcatheter 9 that is transported via a relatively large catheter 8. In one different embodiment, a solid lumen presser may be used instead. The device can be transported as described above, and furthermore, the lumen of the microcatheter for subsequent introduction of the embolic material is not required. Thus, for example, the occlusion device 11 in Figure 1 may be pushed via a transport catheter or microcatheter and connected to a presser rod positioned inside the aneurysm, with the device subsequently being pushed out or the catheter being retracted to expose the device. A thermal, mechanical, or electrolytic removal system can be used to remove the central element 16 of the device from the presser rod. Various removal systems are discussed in US5895385, US5108407, US6500149, US4346712, US8182506, US20100268204, US20110301686, and US20150289879, all of which are incorporated herein by reference. The compression rod and catheter are then retracted. Alternatively, the catheter lumen is subsequently used to introduce other embolic material (e.g., coils or liquid embolic material) into the occlusion device positioned proximal to the aneurysm. Thus, the occlusion device forms a proximal barrier that protects the dome of the aneurysm from impact, and the additional embolic material fills the more proximal section of the aneurysm.

[0097] In one embodiment, instead of a microcatheter, a first catheter can be used to position the occlusion device, utilizing the device shown in Figure 1 connected to a compression rod. A relatively small catheter, particularly one used for embolic material, can then be positioned within the catheter and further positioned via the occlusion device to introduce additional embolic material (i.e., embolic coils or liquid embolic material). The occlusion device can then be removed. Alternatively, the occlusion device can be positioned and removed. The catheter initially used to transport the occlusion device can then be used to transport additional embolic material (i.e., coils or liquid embolic material). In another case (where a separate catheter is used, or where the same occlusion device is reused), the catheter can be guided to another location where it is positioned within the braided structure to transport additional embolic material. In one embodiment, the catheter can be positioned towards the top of the occlusion device near the dome of the aneurysm, thereby filling the aneurysm and occlusion device from bottom to top. In one different embodiment, the catheter can be positioned towards the bottom of the occlusion device, thereby filling the aneurysm and the occlusion device from bottom to top.

[0098] The disc-shaped element in Figure 8-12, the small / large diameter region in Figure 13-14, or the helical ribbon-shaped device in Figure 15 will be connected to the pressing element. Various thermal, mechanical, or electrolytic removal systems can be used to remove the device from the pressing element, including removal systems discussed in the applications cited by reference. Similarly, the catheter used to deliver the occlusion device may subsequently be used to deliver additional embolic materials, such as embolic coils or liquid embolic materials.

[0099] Figure 16-22 shows a press device removal system 45 located near the tip of a long press device 47. The press device 47 is advanced through the catheter 8, and its removal system 47 is activated to remove an occlusion device 48, such as the device 48 described herein. The occlusion device 48 is secured to the press device by an axially movable removal wire 38 on the press device. That is, first, the occlusion device 48 is positioned in the cavity of the coupling fixture 40 on the proximal end of the device 48, preventing the device 49 from moving laterally from the proximal end of the press device 47. A tether connected to the coupling fixture 40 and further connected to the more proximal portion of the removal wire 38, which is exposed from the cut-out area 44 on the tip region side of the press body 36, prevents the device 48 from moving away from the removal wire 38. A spring 42 is positioned between the two to improve flexibility and further improve connectivity between the press body 36 and the coupling fixture 40.

[0100] To activate the removal system 45, the removal wire 38 is retracted towards the proximal end so that its tip moves toward the proximal end, toward the detachment area 44, and beyond the proximal end point of the tether 46 attachment. The tether is connected to the removal wire 38 (for example, by a loose knot or loop-shaped fastener) so that the tether slides relative to the removal wire 38. Thus, the removal wire 38 not only moves toward the coupling fastener 40, but also retracts in a way that allows the tether 46 to slide toward the wire 38 completely, leaving the occlusion device 48 completely disconnected from the press 47. Furthermore, the spring 42 contacts the coupling fastener 40, providing some force or kick to push the occlusion device 48 toward the press 47.

[0101] Figure 17-20 shows one possible mechanism in which the proximal end of the press body 36 is broken, exposing the proximal portion of the wire 38, thereby retracting the removal wire 38 of the press device 47, and allowing the physician to retract the wire 38 towards the proximal end and activate the removal system 45. As shown in Figure 17, the proximal end of the press body 36 preferably includes a brittle area 52 (e.g., one or more holes in the press body 36) and a visual guide 50 that indicates to the user where the destructive tool 54 should be positioned and assists in destructuring the press body 36. Preferably, the brittle area 52 of the press body 36 has sufficient strength not to be broken during the procedure without the lever action applied by the tool 54, thereby preventing the difficult situation in which the occlusion device 48 is unintentionally removed.

[0102] The destructive tool 54 preferably has a path formed to be approximately the same size as the diameter of the base end of the press 36, thereby allowing the tool 54 to slide along the press 36. The tool 54 preferably has a relatively small diameter and includes a narrow area 56 aligned with the brittle area 52, thereby allowing the physician to apply additional force to the brittle area 52 to destruct both the press 36 and the tool 54 itself, as shown in Figures 19 and 20. To facilitate the physician's proper alignment of the narrow area 56, the press 36 preferably includes a window that allows the user to view and align a visual guide 50, as shown in Figure 18. Alternatively, the guide may be configured such that the tool 54 must move quickly to align with the guide, or it may be configured as a tactile stopper, thereby eliminating the need for a window.

[0103] Figures 21-22 show several alternative embodiments of the removal system 45 of Figure 16. Figure 21 shows a removal system 53 that is similar to that of system 45 but does not utilize a spring 42 that provides an additional kick for pushing the connector 40. Figure 22 uses two windows cut out above the connector 40 and two tethers 46A and 46B. One tether 46A is attached to the end of the removal wire 38 and has a loop that surrounds the end of the presser 36. The other tether connects to another proximal end section of the removal wire 38 and further connects to a section of the loop that surrounds the proximal end of the presser 36. In both systems, the knot around the removal wire 36 is loose, so that the connector 40 and implant 48 are removed by pulling the removal wire.

[0104] Embodiments of the occlusion device in Figures 8-12 and 8-13-15 may also be configured to operate similarly to the embodiment in Figure 1. That is, the occlusion device may be pre-mounted on the tip of a microcatheter that is delivered via a relatively larger catheter. In one different embodiment, the proximal end of the occlusion device utilizes an element similar to the central element 16 in Figure 1. The central element will constrain multiple constituent braiding wires together. The central element will be located near the tip of the microcatheter, and a removable tip system similar to the removable tip system referenced above will be used in this system. Similar to the embodiment in Figure 1, the user will place the device in the neck of the aneurysm and optionally deliver embolic material (i.e., embolic coil or liquid embolic material) via the microcatheter and occlusion device. Once the embolic material has been delivered, the user will detach the tip of the microcatheter and retract the microcatheter via the removal concept described above.

[0105] Intracapsular lace-up devices work very well in bifurcated aneurysms, where the transport catheter can be guided relatively straight through the aneurysm. However, in other aneurysms, such as lateral wall aneurysms, the position of the transport catheter is more perpendicular to the entrance of the aneurysm neck, making the placement of intracapsular lace-up devices more difficult. When the intracapsular device is positioned at an angle, the attached pressure body and the relatively rigid properties of the device cause the catheter to try to go straight, and furthermore, the device is positioned at an angle within the aneurysm.

[0106] Figures 23A-23B show a tension system 59 that allows the occlusion device 64 to expand in an offset or curved configuration, thereby avoiding the difficulties described above. Specifically, the tension system 59 includes tethers 58 connected to the leading and leading ends of the braided occlusion device 64. When the press 60 pushes the occlusion device out of the catheter 8, the material of the tethers 58 causes the device 64 to maintain tension on one side of itself while expanding, allowing for maximum expansion to the opposite side. This allows the device 64 to curve or fold in the direction of the tethers 58 while expanding.

[0107] More controlled, curved transport allows the occlusion device 64 to take on its own expanded shape and maximize the chance of filling the aneurysm when the catheter cannot access the aneurysm in a relatively straight trajectory. The tension member maintains tension on the connection of the occlusion device, thereby limiting expansion along one side of the device 64 and allowing it to form a curved shape. In addition, an advantage of this technology is that the tether 58 can be applied to a wide variety of weaving patterns of the occlusion device 64, such as 1 over 1 pattern, 2 over 1 pattern, and 2 over 2 pattern.

[0108] The tether 58 may be an elastic polymer, stretched nitinol or stainless steel, a coil spring, nitinol or stainless steel wire, shape memory wire or ribbon, platinum or tantalum wire or elongated piece. Furthermore, more than one tether may be used, i.e., multiple tethers may be connected in a longitudinal direction or offset along the vertical dimension of the implant. In one embodiment, the tether is a nitinol coil or wire, and a heat source is connected to the tether to change the stiffness properties of the tether.

[0109] Figures 24A and 24B show a braided mesh occlusion device 160 in which the expanded mesh shape is braided to expand in a manner offset from the catheter 8 (or pressure device), thereby allowing for more optimal expansion within the aneurysm when approached at an angle by the catheter 8, as shown in Figure 24B. In other words, when the device 160 expands, its central axis is offset from the central axis of the catheter 8 from which the device 160 expands.

[0110] Such an offset expansion occlusion device 160 can be formed by placing a braided mesh tube or enclosing structure on a mandrel 162 (Figure 24C) having a relatively large-diameter cylindrical structure 162A and a relatively small-diameter cylindrical shape 162B. The small-diameter cylindrical structure 162B is fixed at an offset position from the central axis of the large-diameter cylindrical structure 162A, thereby enabling the offset shape of the occlusion device 160 after thermosetting. Preferably, the braided mesh tube is first formed to form a uniform cylinder or tube, and then the offset shape is achieved by thermosetting. This technique allows the braided cell size of the final occlusion device 160 to be more consistent. In addition, an advantage of this technique is that this offset thermoset shape can be applied to a wide range of braiding patterns for the occlusion device 160, such as 1 over 1 pattern, 2 over 1 pattern, and 2 over 2 pattern.

[0111] In addition, the mandrel 162 may be machined at the end of the large-diameter cylindrical structure 162A so as to surround the joint surface of the small-diameter cylindrical structure 162B, allowing the cylinder to be inserted beyond the small-diameter cylindrical structure 162B, and may have a recess that provides a recess or push-down area surrounding the base end of the occlusion device 162. This recess will be described in more detail with reference to Figures 25A-25D.

[0112] The laced capsule occlusion devices described herein may be terminated proximal and optionally distal by marker bands or other welding techniques, as described elsewhere herein. However, protrusion beyond the laced end face of the proximal or distal end of the occlusion device is generally undesirable for the termination region. For example, a projection at the proximal termination point may extend into the patient's artery or cause unnecessary thrombus formation. In addition, a projection at the proximal termination point may rupture the dome of the aneurysm.

[0113] Figures 25A-25D show how the aforementioned difficulties are mitigated by reducing the outward projection of the braided terminations when the device is expanded. Specifically, Figure 25A discloses an open-end closure device 170 having a base braided termination 170A that recesses inward when expanded. Similarly, Figure 25B shows a closure device 172 having a front braided termination 172A and a base braided termination 172B, both of which recess inward when expanded.

[0114] As shown in Figures 25C and 25D, a mandrel 174 having a relatively large cylindrical portion 174A and a relatively smaller, adjacent cylindrical portion 174B can be used to form an inwardly recessed braided termination. The relatively large cylindrical portion 174A is machined at its end to have a recess 174C having a diameter that allows the relatively smaller cylindrical portion 174B to be placed inside. The recess is preferably curved or concave and is exposed even when the relatively smaller cylindrical portion 174B is inside. The braided structure of the occlusion device is first positioned to cover both cylindrical portions 174A and 174B, and then the tube 176 is moved over a portion of the braided structure on the relatively smaller cylindrical portion 174B and pressed against the recess 174C. Furthermore, a clip 177 is used to hold the position of the tube 176. This movement pushes the braided structure into the recess 174C, allowing the mandrel 174 to be placed in the oven and subjected to thermal curing to achieve the desired recess shape. The mandrel 174 is shown with one recessed end 174C and one relatively small cylindrical portion 174A, while both ends of the relatively large cylindrical portion 174A may have these features to form a closure device 172 having recessed ends at both the base and tip.

[0115] Figures 31A-31B show one different embodiment of a braided closure device 101 having fully braided ends (or both ends) to mitigate the difficulties associated with protruding proximal or tip ends. In other words, instead of closing the ends of a cylindrical braided structure by welding or other techniques, one or more ends are braided to close at the ends of the device 101 such that there are no free ends of wire. In one embodiment, the device 101 includes a cylindrical body having at least one end that terminates in a plurality of loops 101A arranged in a circular pattern surrounding the axis of the device 101, thereby ensuring that the ends do not include any free ends of the basic wire of the braided structure.

[0116] The device 101 can be braided onto a mandrel 102 (shown in the end views of Figures 31A and 31E) having a desired body shape (e.g., a cylinder) and dome or concave ends (both ends, if necessary). Alternatively, the ends of the mandrel may have a relatively flat shape with multiple pins. The mandrel 102 has multiple pins 102A protruding from itself, allowing the user to wind or braid the wire in a desired braiding pattern surrounding the ends of the mandrel 102. A typical braiding technique used with a pre-woven cylindrical portion begins by braiding inward toward the central axis of the device using a second set of wire. This provides a free end of wire at the edge of the cylindrical portion or at the center of the end of the device.

[0117] The braiding pattern of device 101 begins from the center of the end of mandrel 102. Instead of starting the braiding at this location using the free end of each of the multiple wires, the braiding begins substantially away from one of the free ends of each of the multiple wires, thereby ensuring that each end of the wire has enough length to complete the braided structure descending toward the tip of the closure device. The braiding begins using each of the multiple wire-forming loops 101A that form a circular pattern surrounding the central axis of device 101. To help hold these base ends together, each loop 101A is braided such that at least two adjacent loops intertwine with each other. If only two loops intertwine with each other (i.e., on the left and right sides), the multiple loops 101A form a circular pattern with a central opening, as shown in Figures 31B and 31C. If loops 101A intertwine with each other with loops 101A diagonally or on the opposite side of the circular pattern, device 101 substantially lacks a central opening, as shown in Figure 31D. Furthermore, a larger loop 101A size results in a larger potential central opening (Figure 31C), and a smaller loop 101A size results in a smaller arbitrary potential central opening (Figure 31D). The proximal end of the device 101 can be woven on the mandrel 102 to have an axial central opening (as described with other embodiments herein and used for transport embolization devices) or to not have an axial opening.

[0118] After the desired braiding is performed, the mandrel 102 and device 101 are thermoset so that the device configuration can be held on the mandrel 102. The braided end of device 101 can be connected to a press or catheter via a tether 101B joined or looped through a portion of the end, and can also be made detachable by one of the detachment mechanisms described elsewhere in this specification (Figure 31F).

[0119] Figures 31C and 31D show two alternating knitting patterns for the ends of a closure device. Figure 31C is terminated with multiple interconnected circular loops arranged in a ring so that the center or axial point of the device is open. Figure 31D is terminated with multiple interconnected oval loops arranged to cover the center or axial point of the device, thereby closing the center of the end of the device.

[0120] Figures 26A–26F show several different designs for intravesical devices, many of which include multiple folding elements incorporated within the knitted pattern. The devices shown in these drawings are manufactured and thermoset into a single configuration, which allows the various elements to fold together to form a knitted device. During transport, the device takes on a long, unfolded configuration, in which all elements are arranged flat and linearly. Upon removal from the transport catheter, the various layers then apply pressure to the pre-arranged layers in sequence, causing the knitted structure to take on its folded configuration. This folding effect is particularly useful for occlusion purposes as it compresses and packs the knitted structure and further increases the occlusion density of the mesh. Alternatively, the long transport shape of the device may also be stretched compared to the shape that is ultimately placed, utilizing the same long folded shape. In one embodiment, the tip of the braided structure can utilize a longer stalk so that the stalk presses against and expands the dome of the aneurysm, thereby providing a soft tip cap that the rest of the braided structure can contact and fill the remaining portion of the aneurysm.

[0121] Figure 27A shows a sealing device 69 that can be used with an occlusion device 66, as described herein. The sealing device 69 comprises a concave sealing portion 70 that is connected to the occlusion device 66 by a connecting member 68. The sealing device 69 can be transported to the tip of the device and / or the proximal end of the device 66. When positioned at the tip of the device 66, the sealing device 69 contacts the dome of the aneurysm and provides a tip scaffold from which the remainder of the mesh occlusion device 66 can fill the remainder of the aneurysm. When positioned at the proximal end of the device, the sealing device 69 seals the neck of the aneurysm, preventing the occlusion device from being positioned outside the aneurysm. Furthermore, if an embolization device (i.e., an embolization coil or liquid embolization material) is placed following the intracapsular device, the proximal sealing device 69 provides a capture-type element that prevents the embolization material from detaching from the aneurysm. In one embodiment, the sealing element consists of an umbrella-shaped continuum of wires that utilizes a membrane that optionally covers multiple wires. When the sealing device 69 is connected to the occlusion device 66 within the aneurysm, the connecting member 68 has a plurality of hooks or other engaging members that can engage with the occlusion device 66 during subsequent transport. However, it is also possible to connect the sealing device 69 to the occlusion device 66 before transport, and therefore the connecting member 68 may also be equipped with adhesive, welding, or other engaging mechanisms.

[0122] Figure 27B shows a proximal and tip sealing device 69 used in a similar arrangement to the occlusion device 72, which is formed to consist of three folded layers of a braided mesh. A connecting member 68 is connected to the inner filling member 71 and is further positioned inside the multiple layers of the occlusion device 72, thereby enhancing the occlusion of the device. Figure 27C shows a similar arrangement to that of Figure 27B, except that the inner filling member 71 is not used. The filling structure 17 can take the form of a wire, hypotube, or sheet-cut structure. To facilitate occlusion of the target area, the filling structure 17 can be molded into numerous forms such as linear, corrugated, sinusoidal, and / or coiled shapes. In one embodiment, the filling structure may be made from nitinol wire having a diameter of about 0.002” to about 0.005”. Other embodiments may utilize shape-retaining polymers, cobalt-chromium, and spring-tempered stainless steel. In one embodiment, each wire is equipped with a tantalum coil for contrast imaging, the tantalum coil being wrapped around the wire and extending over the entire wire or a sufficient length of the wire, allowing for visualization of the device during the procedure.

[0123] Figure 27d shows the wire substructure of the sealing device 69, which does not have its own mesh or membrane cover because it is transported from the catheter. During transport, the sealing device 69 takes on a linear, elongated shape when folded within the aneurysm, and then expands to an umbrella shape when removed.

[0124] This sealing concept may be useful in other embodiments. For example, a neck bridge element may utilize a proximal sealing device to occlude the neck of the aneurysm, after which other embolic material (e.g., coils or liquid embolic material) may be placed inside the aneurysm and received by the sealing device. In Figures 27E and 27F, the occlusion devices 75, 77 include a wire scaffold 78. In Figure 27E, the wire forms a spherical shape, and the device is intended to substantially fill the aneurysm. In Figure 27F, the wire is elongated, forming a partial spherical shape, and the device is not intended to substantially fill the aneurysm. The proximal and distal ends of the wire scaffold 78 may utilize sealing members 76, in which case all wires are bound together by the sealing members. The proximal end of the device may utilize a mesh or membrane to seal, for example, the neck of the aneurysm. The cervical seal is delivered to the tip of a pressure device from which the cervical seal is removed, after which a catheter is introduced into the cervical seal to deliver additional embolic material such as coils and / or liquid embolic material. Alternatively, the cervical seal is delivered to the tip of an open lumen pressure device (similar to a microcatheter), the cervical seal is positioned within the target site, and subsequently the open lumen of the pressure device is used to deliver additional embolic material. The pressure device is then removed. Alternatively, a mesh / membrane can be placed within the scaffold, as shown by element 74 in Figure 27E. By placing the mesh or membrane in this manner, an occlusion region is essentially formed that extends from the neck of the aneurysm to the top of the membrane. The subsequently introduced embolic material (i.e., coils or liquid embolic material) will be trapped within the region defined by the membrane. Several variations of this concept include wire-forming scaffolds, but the mesh / membrane may be positioned to surround the entire circumference of the scaffold, only the center of the scaffold, or only the tip of the scaffold. The cervical bridge takes a folded configuration when housed in the transport catheter and takes its expanded shape when transported and removed from the catheter (see Figures 27E-27F). The mesh / membrane material used may consist of polymer or metallic material.The mesh / membrane can be fixed to the wire scaffolding by adhesive, stitching, heat treatment, or other means. Although wire scaffolding has been described, various variations are possible. For example, the scaffolding primarily utilizes wire to form the structure, but link elements (imagine a gem pendant or a chain link) may be selectively incorporated along the length of the wire to enhance flexibility. Alternatively, the scaffolding may be constructed from laser-cut sheets.

[0125] Figure 30 shows a mandrel and winding technique that can be used to wind a braided structure to form an occlusion device. This design utilizes tension and gravity to wind the braided structure. First, a plurality of wires 96, including the braided structure, are placed on a mandrel 94. The top of the mandrel has a plurality of notches or grooves for housing the plurality of wires. Alternatively, in the initial state, the plurality of wires may be placed on the top of the mandrel and secured by tape or other means to maintain tension on the plurality of wires. A plurality of weights 98 are placed at the bottom of the plurality of wires, and a braiding ring 100 is also utilized. The braiding ring has a plurality of notches for housing the plurality of wires, and the braiding ring is selectively movable up and down relative to the mandrel, and can also be locked in the desired position. The braiding ring can be used to control the angle of the wire braided structure, and by holding the braiding ring in a high position, a smaller braiding angle and a denser braided structure can be obtained, while by holding the braiding ring in a low position, a larger braiding angle and a looser braided structure can be obtained. The user can maintain a constant tension and braiding angle of the braided structure by lowering the braiding ring as they wind the wire to cover the mandrel. The user manually winds various wires onto each other on the upper and lower sides to form the braided structure. To maintain a constant braiding angle, the braiding ring is lowered as the user winds each increasing section of the braided structure. To reinforce the shape, the device can be heat-cured after winding is performed.

[0126] In several parts of this description, the use of briders to form braiding devices has been described, and typically these briders utilize a mandrel that moves longitudinally and a series of bobbins mounted within a carrier frame. In this case, the bobbins rotate within the carrier frame in various configurations. The rotation of the carrier and the bobbins, coupled to the longitudinal movement of the mandrel, enables the braiding of the device to be performed. In one different embodiment, a rotatable brider may be used; that is, instead of multiple bobbins housed within a circulating carrier or circulating brider, the brider itself may have the freedom to rotate. Figure 32A shows a typical shape of the intersection of a wire braiding structure. Each line represents a wire, and thus the intersection of four wires forms the shape shown. For simplicity of reference, these four wire intersections will hereafter be referred to as cells. Since the braiding angle in Figure 32A is constant, a diamond-shaped cell shape is typically generated during a typical braiding process. Further developments are possible by adding rotation to the brider itself, in addition to the rotation of the bobbins and carrier. By applying rotation to the brider, the winding angle shifts as the brider winds around the mandrel, changing the shape to a rhomboid type, shifting the angle towards a parallelogram type configuration, and enabling more distorted shapes, such as one of the examples shown in Figures 32B-32C. One shape can be manufactured by rotating the frame clockwise, and a different shape can be manufactured by rotating the frame counterclockwise. This can be useful when different flexibility is desired in selective regions of the manufactured braided device (i.e., occlusion device). If a more elongated braided structure section is present in Figures 32B-32C, it is possible to give that section different stiffness characteristics than the shape in Figure 32A. For example, perhaps the manufacturer would want to form a braided device so that the majority of the device has general stiffness, but the central portion has different stiffness characteristics.As the central section of the braided structure is wound, the user can rotate the carrier frame to form the type of cell shape shown in Figures 31B-31C. This allows for changes in the device's rigidity characteristics in specific areas. Such a process is automatable, and therefore, for example, the braiding process is typically automated, and the amount (capacity) of rotation of the carrier frame is also automated and can be considered as different variables in the winding operation. Several other variables include the longitudinal speed of the mandrel, the rotation speed of the carrier and multiple bobbins that wind the wire around the mandrel, and the angle of the braided structure.

[0127] Several other embodiments may utilize a tip-fill structure and a proximal neck bridge structure. The filling structure can take the form of a wire, hypotube, or sheet-cut structure. The filling structure can be molded into numerous shapes, such as linear, corrugated, sinusoidal, and / or coiled, to facilitate occlusion of the target area. In one embodiment, the filling structure may be made from a nitinol wire having a diameter of about 0.002”–0.005”. Several other embodiments may utilize shape-retaining polymers, cobalt-chromium, and spring-tempered stainless steel. In one embodiment, each wire is equipped with a tantalum coil for contrast imaging, the tantalum coil being wound around the wire and extending over the entire wire or a sufficient length of the wire to allow visualization of the device during the procedure. The neck bridge may include a mesh braided element positioned in the neck of the aneurysm or just inside the aneurysm to prevent the filling structure from coming out of the aneurysm. Alternatively, the cervical bridge may include a structure comprising multiple disc-like elements, where one disc is located inside the aneurysm and the other discs are located outside the aneurysm. The cervical bridge may be a braided structure made of metal (i.e., nitinol, stainless steel, cobalt-chromium) or polymer.

[0128] Figure 35 shows a tip-wire-filled structure 110 and a proximal-mesh neck bridge structure 112A used to occlude an aneurysm. The device is delivered from a catheter 8. In one embodiment, the tip-filled structure 110 and the proximal-mesh / neck bridge structure 112A are connected, and the entire system is pressed via a core wire-based pressing system. In this case, a removal system is incorporated at the proximal end of the core wire and mesh / neck bridge, allowing the device to be removed. Any mechanical, thermal, or electrolytic removal system can be used, including several other removal concepts disclosed herein.

[0129] Figure 36 shows an embodiment similar to that in Figure 34, except that it has a double-disk neck bridge structure 112B. In this embodiment, the neck bridge 112B may include multiple disc-shaped elements, with one disc located inside the aneurysm and the other multiple discs located outside the aneurysm.

[0130] In one embodiment, the filling structure 110 is fixed to the tip of the cervical bridge 112A / 112B. During transport, the entire system, along with the filling structure 110 located at the tip of the cervical bridge, folds inside the catheter 8. In one different embodiment, the cervical bridge structure 112A / 112B may be pre-positioned at the tip of the catheter 8 and located outside the catheter 8. In one embodiment, the catheter 8 extends through the cervical bridge 112A / 112B, providing a lumen for the transport of additional embolic material into the aneurysm 14 via the cervical bridge 112A / 112B.

[0131] In one different embodiment, the cervical bridge structure 112B shown in Figure 34 may utilize one or more lumens, and the filling structure is delivered into the aneurysm 14 via the cervical bridge 112B through one or more lumens. The filling structure is delivered via the catheter and the cervical bridge, and after the cervical bridge is in place, it is placed via the cervical bridge.

[0132] In one embodiment, a filling structure 110 is fixed to a neck bridge 112A / 112B at the proximal end of the filling structure 110. The filling structure 110 and the attached neck bridge are pressed through the catheter 8 by a proximal pressing system. A removal system (electrolytic, thermal, mechanical, or other removal systems as described or previously incorporated herein) links the pressing device to the neck bridge. The pressing device is used to push the neck bridge and filling structure out of the catheter, and then the removal system is used to remove the system from the pressing device, and then the pressing device is withdrawn. Figure 37 shows a cross-sectional view of such an arrangement in which the filling structure 110 is fixed to the proximal portion of a neck bridge (not shown), and the entire device is transported through the catheter 8. Three filling structures are used. The filling structure 110 includes a wire 111 surrounded by a radiopaque coil 116 to aid visualization. The radiopaque coil 116, in one embodiment, contains tantalum or tungsten and has a thread-like shape of 0.001”, which is slightly larger in diameter than the wire 111, as the coil 116 is positioned to surround the wire 111. The neck bridge 112A / 112B is located on the proximal end side of the filling structure. A proximal-side presser, such as a core wire presser, is connected to the neck bridge 112A / 112B. A removal system utilizing thermal, mechanical, or electrolytic means can separate the presser from the neck bridge 112A / 112B. Any removal systems discussed herein and any systems invoked by reference are also available.

[0133] Figures 38 and 39 show one different embodiment in which the proximal neck bridge structure 112B (alternatively, 112A) has an internal channel 124 connected to the catheter 8, such that a continuous lumen exists through the neck bridge 112B. The neck bridge 112B is located at the tip of the catheter 8. In one different embodiment, when the catheter 8 is positioned appropriately (i.e., near an aneurysm or treatment site), a portion of the neck bridge 112B is located at the proximal end of the catheter 8, and a portion is located inside the catheter 8, and a removable pressing element is used to push the neck bridge 112B out of the catheter 8. Alternatively, the catheter 8 can be retracted to expose the entire neck bridge 112B. Since the neck bridge 112B contains a lumen, when the neck bridge is positioned appropriately, the lumen can be used as a conduit for pushing embolic material (e.g., embolic coils) into the treatment site (e.g., an aneurysm) through the neck bridge 112B. The cervical bridge 112B prevents the embolization coil from becoming dislodged from the treatment site and also avoids other complications. The cervical bridge may be pushed out from the catheter 8 so that the catheter 8 can be withdrawn, or the catheter 8 may be equipped with a removal system (thermal, mechanical, electrolytic, other removal devices described herein, other removal systems incorporated herein by reference) for removing the catheter from the cervical bridge.

[0134] U.S. Patent Application Publication 20150173772 discloses an embolization coil system that utilizes multiple removal elements along the length of the coil to form a variable removal system, where a selective length of the coil is positioned within the target treatment site. All disclosures of the said U.S. Patent Application Publication are incorporated herein by reference. One embodiment shown in Figures 38-39 makes available a variable removal coil system along a cervical bridge concept. The variable removal system utilizes contact elements on a catheter that interact with multiple links between multiple embolization coil segments, and the multiple links include disassemblable elements that disassemble when the contact elements on the catheter electrically interact with the multiple coil rings to separate the coil segments. Element 124 in Figure 39 represents an internal lumen connecting the inside of the cervical bridge 112. This lumen is connected to a capsule 126 which includes a disassemblable link mechanism that separates the cervical bridge from the catheter transport system. Multiple embolic coils 120, pressed through a catheter (see Figure 38), include multiple links 122, the links electrically interacting with a capsule element 128 (see Figure 40) to detach the appropriate segment of the embolic coil within the blood vessel. The catheter 8 provides a transport platform for both the multiple embolic coils and the cervical bridge (connected to the tip of the catheter) transported through the catheter. The inner lumen and the attached cervical bridge are separated from the catheter by a disassemblable capsule 126. The capsule is equipped with a disassembly mechanism to remove the cervical bridge 112 and the inner lumen 124 connecting the inside of the cervical bridge from the catheter, as described above. Several wires 130 are used to provide current to capsules 126 and 128, with a voltage source (i.e., a battery) located at the base end of the system, providing current between the battery and the capsule. The inner lumen 24 may contain a number of materials, including polymers, metals, and metal meshes.

[0135] Several embodiments have been described that utilize a neck bridge located in or inside the neck of an aneurysm (Figure 35) or a neck bridge having one portion located inside the aneurysm and the other portion located outside the aneurysm (Figure 36). Other embodiments utilize a floating neck bridge, in which the neck bridge is placed inside the aneurysm and multiple filling structures or multiple embolizing coils are placed inside the aneurysm so that these embolizing materials fill the internal space of the aneurysm and further push down the neck bridge, resulting in the neck bridge sealing the neck of the aneurysm. In one embodiment, the catheter 8 positioned in Figures 35-40 is a microcatheter having a diameter of 0.017”-0.021””.

[0136] Another different embodiment of the occlusion device 143 in a compressed, elongated state while being transported within the catheter is shown in Figure 41. Figure 42 shows the expanded configuration as it emerges from the catheter 8. The device 143 comprises a number of structural loops or struts 138 connected to the tip occlusion portion 140. The proximal occlusion portion 140 forms a dome-shaped or concave occlusion region within the aneurysm when used within the aneurysm, while the struts 138 assist in the expansion of the occlusion portion 140 and fill the area beneath it.

[0137] Multiple connecting structures 142 are fixed to the proximal contact portion 140 (e.g., by adhesive or welding) and further fixed to the multiple struts 138 (e.g., by loops through which the multiple struts 138 are inserted), thereby allowing the multiple struts 138 to be connected to the proximal occlusion portion 140. The multiple struts can be made of metal or polymer, such as nitinol wire or hypotube, and radiopaque items can also be used to aid in contrast imaging. The proximal occlusion portion 140 may have a pre-set curved shape or may contain a malleable thin material that can conform to the shape of the aneurysm. In one embodiment, the proximal occlusion portion 140 is made of a thin film polymer (e.g., PTFE, ePTFE, polyethylene) or a metal (e.g., nitinol, stainless steel). The multiple struts 138 help to control the expansion of the proximal contact portion and further help to ensure that the device 143 is positioned gradually.

[0138] The proximal ends of the multiple struts 138 are connected to the cylindrical collection band 136, for example, by inserting them through openings within the collection band 136. A coil 134 (made of stainless steel in one embodiment) is connected to the proximal end of the collection band 136 and to the tip of the proximal band 132 on the presser 131, thereby assisting the multiple struts to be pushed forward and open, as well as the proximal closure portion 140. The coil 134 takes a compressed shape when the device 143 is inside the catheter 8, and the struts 138 also take a compressed, elongated shape. Therefore, the coil 134 has stored energy, and as the device 143 is transported and the multiple struts 138 begin to open, the coil 134 releases the stored energy, assisting in further expanding the multiple struts, as well as the attached proximal contact portion 140.

[0139] The presser 131 may include a core wire or hypotube system, allowing the user to manipulate the device 143 through the catheter 8 and blood vessel. A removal system may be provided at the tip of the presser. In one embodiment, the coil 134 is part of the removal system, with a detachable tether located within the lumen of the coil 134. Multiple wires can be connected to one end of the coil, and these wires are connected to a voltage source, such as a battery, at the proximal end of the system, allowing the user to initiate a removal sequence (i.e., by pressing a button) that heats the coil and detaches the tether in order to remove the device from the presser. The removal system may be coplanar with the coil 134 or at the proximal end of the coil 134 to prevent the coil 134 from advancing into the blood vessel. In one embodiment, the removal system utilizes a tether connecting the coil 134 to a collection band 136, with the coil firmly connected to element 132. Therefore, when the removal sequence is initiated and the device is positioned, the tether detaches because the base end of the presser is attached to the base end band 132, but the coil remains attached to the presser.

[0140] Furthermore, a tension element 141 can be used to connect the base-end closure portion 140 to a plurality of support columns 138. The tension element 141 may be a thin wire or tether and helps to control the expansion of the base-end portion 140 and the plurality of support columns 138 so that the opening is slow or not too abrupt when transported.

[0141] Multiple support columns 138 are heat-treated to have a shape-memory open shape as shown in Figure 40 in one embodiment. This shape memory allows the multiple support columns 138 to open quickly and retain their shape as a memorized open shape, which helps the tether control the opening of the device during transport. The tension element 141 may alternatively connect the area between the base-end closure portion 140 and the press 131, or the base end side of the base of the multiple support columns 138, band 136, coil 134, element 132, or press 131. Fixing the base end of the tether to a non-support element has the advantage that the tether can be fixed to an element that does not expand, resulting in very precise control of the placement. Fixing the base end of the tether to a support column 138 does not restrict expansion because the base end is fixed to something that expands during placement. The position of the tether's base end is adjusted based on whether the user wants more precise or less precise control over device extension during placement, and the materials used in the device and the size of the device become important variables during operation.

[0142] Figures 43-45 show an occlusion device 145 having a concave upper occlusion element 144A and a concave lower occlusion element 144B that expand into the dome and neck of the aneurysm, respectively. The upper and lower elements 144A and 144B may be composed of various components including metal mesh, metal sheet, and polymer. A coil 146 connects to the upper and lower occlusion elements 144A and 144B, connecting both elements 144A and 144B and allowing for variations in distance to accommodate different aneurysm sizes. The upper element 144A is the first element to be placed inside the aneurysm, and the lower element 144B is the last element to exit the catheter. As shown in Figures 44 and 45, the device 145 may optionally include a frame 148 that expands within the upper and lower elements 144A and 144B. Frame 148 has multiple loops that extend radially across the openings of the concave openings of elements 144A and 144B, thus serving as a scaffold for opening and closing the top and bottom elements while simultaneously providing more precisely controlled expansion and contraction of the device. Figure 45 shows device 145 in the folded configuration taken while being transported through the catheter. When folded, frame element 148 is positioned to cover a portion of the coil (in the contracted state, compared to the expanded state, it can be thought of as an umbrella-shaped frame). When expanded, the frame elements are arranged flat on the same plane and positioned within the top and bottom elements, respectively.

[0143] Other embodiments may utilize the tip-filled structure 110 described above and shown in Figures 35-36, but may also utilize the device shown in Figure 1, which comprises a holding portion 10 and a support portion 12.

[0144] Various mandrel and winding techniques used to form occlusion devices have already been described. One different embodiment utilizes a removable mandrel, in which case crushing, chemical dissolution, or other techniques can be used to remove the mandrel after the manufactured device has been woven to cover the mandrel. The manufactured device may be a number of devices, including an occlusion device, such as a braided therapeutic device. Conventional braiding techniques utilize the steps of braiding the device to cover the mandrel, thermosetting the device covering the mandrel, and subsequently removing the mandrel. The mandrel may optionally comprise a number of pins around which the device is woven. In this case, a non-cylindrical, tapered occlusion device is formed (i.e., both ends are smaller than the center), and the step of removing the mandrel may be difficult due to the tapered shape of the mandrel and the occlusion device. One way to solve this problem is to use a mandrel that is removable by mechanical means (i.e., crushing) or chemical means (i.e., chemical dissolution), remove the mandrel, and leave the braided device.

[0145] In one embodiment, the mandrel is made of ceramic or glass. Both ceramic and glass are highly brittle, and therefore the mandrel can be mechanically broken with a hammer to remove it after the device has been formed. If a glass mandrel is used, the glass can be coated with a silicon or latex material to prevent the device wound to cover the mandrel from slipping. In one different embodiment, an aluminum mandrel is used, and a concentrated sodium hydroxide solution is used to dissolve the mandrel. The concentrated (i.e., 1-10M) sodium hydroxide solution can be used at a high temperature (i.e., 100-150 degrees Fahrenheit) where it can be confident that it is liquid. The aluminum mandrel dissolves slowly, but this technique does not dissolve other materials such as nitinol that will be used to wind the intervention device. Thus, the mandrel disappears, and the device remains. In one different embodiment, the mandrel is a sand mold. The sand-cast mandrel is removable by a liquid jet, and when the formed mandrel is destroyed, only sand remains. In one embodiment, the mandrel has an aluminum core, and the sand mold is constructed to cover the upper side of the aluminum core. In another embodiment, a removable mandrel may be utilized that includes a wire-forming structure similar to a braided structure formed to cover the mandrel. Thus, the mandrel includes a first braided structure, and a second braided intervention device is wound to cover the braided mandrel. The braided mandrel is easily compressible to remove the braided intervention device. The braided mandrel must include any wire structure that is both strong and compressible and can withstand high curing temperatures for thermosetting, such as 316 stainless steel or 321 stainless steel. One different embodiment uses a mandrel comprising a first layer (i.e., a typical metal mandrel) and a second layer, in which case the second layer comprises any of the removable mandrel elements described herein to form a double or multiple layered intervention device.The user winds the first layer of the device so as to cover the base mandrel. A removable second mandrel layer is then positioned to cover the first mandrel layer and the first braided layer of the intervention device. The second layer of the intervention device is then wound to cover the second (removable) mandrel layer. The removable mandrel section is then removed, leaving the first mandrel and the multi-layer intervention device. Although this process has been described for forming a two- or double-layer device, additional removable mandrels may be added to form braided intervention devices with three, four, five, or more layers.

[0146] While the present invention has been described in terms of specific embodiments and uses, those skilled in the art can obtain additional embodiments and modifications by referring to this teaching without exceeding the scope of the invention as described in the claims or departing from the principles of the invention. Therefore, it will be understood that these drawings and this specification are provided as examples to facilitate a comprehensive understanding of the invention, and these drawings and this specification do not constitute a limitation of the scope of the invention.

Claims

1. An occlusion device for medical procedures on the lumen, A retaining portion is formed from multiple wires braided into a cylindrical shape with the proximal ends closed, and the closed proximal ends have a first opening. A catheter having a tip detachably connected to the retaining portion, the catheter having a passage extending to the distal end of the catheter and aligned with the first opening of the retaining portion. The embolic material within the catheter passage can advance through the passage, through the first opening, and into the cylindrical shape of the retaining portion.

2. The occlusion device according to claim 1, further comprising a retaining portion having a plurality of loops arranged within the cylindrical shape of the retaining portion, and further having a second opening aligned with the first opening.

3. The system according to claim 1, further comprising a central element having a plurality of loop openings arranged around the periphery of the central element, through which wires forming the plurality of loops pass, the closure device further comprising a third aperture aligned with the second aperture and the first aperture.

4. The occlusion device according to claim 2, wherein the plurality of loops of the retaining portion further comprises a first plurality of loops located at the closed proximal end of the retaining portion and a second plurality of loops located distal to the first plurality of loops.

5. The closure device according to claim 1, wherein the closed proximal end of the retaining portion is formed from a plurality of triangular flaps connected to each other at their ends.

6. The closure device according to claim 1, wherein the closed proximal end of the retaining portion is terminated by a cylindrical marker band having a passage aligned with the first opening of the closed proximal end of the retaining portion.

7. The closed proximal end is a wire further comprising a braided closed end having a plurality of interconnecting loops arranged in a ring around the axis of the closing device such that the closed proximal end does not include any free ends of the plurality of closed proximal ends.

8. The occlusion device according to claim 1, wherein the retaining portion is removable from the distal end of the catheter.

9. The occlusion device according to claim 1, wherein the distal end of the catheter further includes a sacrificial material further connected to the retaining portion, and the distal end of the catheter further includes a heater positioned near the sacrificial material for melting the sacrificial material and removing the retaining portion from the catheter.

10. An occlusion device for medical procedures on the lumen, A three-dimensional structure formed from multiple braided wires and selectively detachable from a delivery device, The three-dimensional structure has a linearly compressed shape within the delivery device, and the three-dimensional structure has an expanded state in which it expands axially, offset at a longitudinal angle from the axis of the distal end of the delivery device.

11. The occlusion device according to claim 10, further comprising a tether connected along the side of the three-dimensional structure between the distal end and proximal end of the three-dimensional structure, wherein the three-dimensional structure is curved in the direction of the tether.

12. The occlusion device according to claim 10, further comprising a plurality of tethers aligned in series in the longitudinal direction between the distal and proximal ends of the three-dimensional structure.

13. The system further comprises a first tether connected along a first side of the three-dimensional structure and a second tether connected along a second side of the three-dimensional structure. The 3D structure is positioned on a second side of the 3D structure so as to curve away from the axis of the closure device.

14. The occlusion device according to claim 11, wherein the tether comprises an elastic polymer, a stretched nitinol or stainless steel spring coil, a nitinol or stainless steel wire, a shape memory wire or ribbon, or a platinum or tantalum wire.

15. The occlusion device according to claim 10, wherein the expanded state of the three-dimensional structure is heat-set to expand at an axial offset with a longitudinal angle from the axis of the distal end of the delivery device.

16. The occlusion device according to claim 10, wherein the three-dimensional structure is created by arranging a braided mesh structure on a mandrel having a first cylindrical portion and a second cylindrical portion smaller than the first cylindrical portion and attached to the end of the first cylindrical portion. The method according to claim 1, characterized in that the braided mesh structure and the mandrel are heated to impart the shape of the mandrel to the braided mesh structure.

17. The occlusion device according to claim 10, wherein the catheter further comprises a heating coil configured to cause separation of the three-dimensional structure from the catheter.

18. An implant delivery system, Implants; A delivery tube having a continuous lumen, wherein a delivery tube operably connected to the distal portion of the delivery tube, A heater, and a sacrificial layer extending around a portion of the circumference of the distal section of the delivery tube, The heater melts the sacrificial layer, allowing the implant to be removed from the delivery tube.

19. The implant delivery system according to claim 18, wherein the sacrificial layer is located between the heater and the cover piece.

20. An occlusion device for medical procedures on the lumen, A three-dimensional structure comprising a cylindrical body and a plurality of wires braided together to form a braided enclosed end of the cylindrical body, the braided enclosed end comprising a plurality of interconnected loops and free from any free end of the plurality of wires.

21. The closure device according to claim 20, wherein the plurality of loops are arranged in an annular configuration and form an opening at the center of the braided closure end.

22. The occlusion device according to claim 21, wherein each of the plurality of loops is interwoven with two adjacent loops of the plurality of loops.

23. The closure device according to claim 20, wherein the plurality of loops are arranged in an annular configuration and substantially have no opening at the center of the braided closure end.

24. The closure device according to claim 23, wherein each of the plurality of loops is interwoven with a diagonal or opposing loop of the plurality of loops.

25. The system further comprises a tether member positioned through the closed end and further connected to the delivery catheter, wherein the tether member is detachable via a separation mechanism on the catheter.

26. A method for braiding a blocking device, The process involves preparing a mandrel having a cylindrical body and a convex end, wherein the cylindrical body and the convex end have a plurality of pins extending from them. The steps include braiding multiple wires into multiple intertwined loops around the center of the convex end of the mandrel, and, Continue the braided pattern around the convex ends and beneath the cylindrical body.

27. The braiding method according to claim 26, wherein the step of braiding the plurality of wires into a plurality of weaving loops further includes the step of braiding the plurality of wires such that each of the plurality of weaving loops is woven with at least two adjacent loops from the plurality of weavings.

28. The braiding method according to claim 27, wherein the plurality of interwoven loops are arranged in a circular pattern to form a central opening.

29. Braiding the plurality of wires into a plurality of interwoven loops further comprises braiding the plurality of wires such that each of the plurality of interwoven loops is interwoven with an opposing or diagonal loop from the plurality of interwoven loops.

30. The braiding method according to claim 29, wherein the plurality of interwoven loops are arranged in a circular pattern that substantially does not have a central opening.

31. The braiding method according to claim 26, further comprising passing a tether member through one or more parts of an occlusion device and connecting it to a catheter.

32. A method for forming an occlusion device, A step of preparing a mandrel having a first cylindrical portion and a second cylindrical portion, wherein the second cylindrical portion has a smaller diameter than the first cylindrical portion, and the second cylindrical portion is connected to the end of the first cylindrical portion at a position offset from the central axis of the first cylindrical portion. The process involves placing a cylindrical braided mesh on the first cylindrical section and the second cylindrical section, The process includes the steps of fitting a portion of the braided mesh to a second cylindrical portion and heat-setting the braided mesh onto a mandrel.

33. The method according to claim 32, wherein fitting the portion of the braided mesh to the second cylindrical portion further includes advancing a tube on the portion of the braided mesh and on the second cylindrical portion.

34. The method according to claim 33, wherein the end of the first cylindrical portion further includes a recess around the second cylindrical portion, and the tube is further advanced into the recess.

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