According to the described preferred embodiments, the mesh-like tube includes a plurality of filaments of bio-compatible material extending helically in an interlaced manner in opposite directions so as to form a braided tube. 6,093,199, Wallsten U.S. Pat. The filaments can be made of any suitable material which are bio-compatible and which can be worked into a braid. can be achieved by increasing or decreasing the braiding angle, as described below with respect to specific examples. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS, Filters implantable into blood vessels; Prostheses, i.e.
The circumference is defined in macro scale. CONFIRMATORY ASSIGNMENT;ASSIGNORS:YODFAT, OFER;LIEBER, BARUCH;GRAD, YGAEL;AND OTHERS;REEL/FRAME:023564/0525;SIGNING DATES FROM 20091029 TO 20091102, Free format text: Typical microcatheters suitable for this procedure are disclosed in U.S. Pat. The difficulties include not only in producing such stents of different permeabilities, but also in deploying them such that the portion of low permeability is exactly aligned with the aneurysm neck. Rupture of intracranial aneurysms leads to subarachnoid aneurysmal hemorrhage (SAH) which has a 30-day mortality rate of 45%, and results in approximately half the survivors sustaining irreversible brain damage [1, 2].
The filaments could also be of non-circular cross-section, such as of square or rectangular cross-section, in which case it is preferred that they have a circumference of 40-180 m. 7. Also aneurysm perforation may occur during placement of coils into the aneurysm. The same is true with respect to bifurcations of a blood vessel splitting into one or more branch vessels, which may also be in the vicinity of an aneurysm. When the device is implantable in a blood vessel having an aneurysm at or proximate to one or more perforating vessels, or a bifurcation leading to a branch vessel, the windows defined by the filaments of the braided tube are such as to reduce the flow of blood therethrough to the aneurysm to decrease the possibility of rupturing it, but not to unduly reduce the blood flow to the perforating or branch vessels to the degree likely to cause damage to tissues supplied with blood by such vessels. FIG.
Another object of the invention is to provide such an intraluminal device particularly useful for implantation in a blood vessel having an aneurysms at or proximate to one or more perforating vessels and/or a bifurcation leading to a branch vessel such as to reduce the blood flow to the aneurysms while still maintaining patency in the perforating and/or branch vessels.
1. Because of the high mortality and morbidity rates, and because the condition of many patients does not permit them to undergo an open operation, the surgical procedure is often delayed or not practical. According to another aspect of the present invention, there is provided a method of treating an aneurysm in a blood vessel, which may be proximate to one or more perforating vessels and/or to a bifurcation leading to a branch vessel, by using intraluminal devices having the above combination of features. 6 schematically illustrates how the bending rigidity or flexibility of a braided tube varies with the diameter of the filaments. 3.
As will be appreciated, if a constant diameter braided tube device is inserted into such a variable-diameter lumen, this may result in a defective anchoring of the device at the larger diameter portion of the lumen, and in a possible risk of the migration of the device within the lumen. Surgical treatment of vascular intracranial aneurysm is accompanied by a mortality rate of 3.8% and a morbidity rate of 10.9% [3]. The method has 4% morbidity and 1% mortality rate and achieves complete aneurysm occlusion in only 52% to 78% of the cases in which it is employed.
7 schematically illustrates an intraluminal device implanted in a blood vessel having a plurality of perforating vessels in the vicinity of an aneurysm; and. In the described preferred embodiments, the windows in the mesh-like tube produce a porosity index of 50%-85%, preferably 60%-75%. 5 is of lower flexibility but of higher strength. 6,258,115. ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION, Free format text: The braid pattern illustrated in FIG.
ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Additionally, particularly in tortuous, ectatic vessels, existing stiff stents are difficult to introduce and may results in kinking such as to cause the failure of the deployment process.
3 more particularly illustrates the braid pattern of FIGS. 6 illustrates the region of filament diameters for use in constructing braided tubes in accordance with the present invention. 4 illustrates another braid pattern, wherein one filament extending in one helical direction is interwoven over and under two filaments extending in the opposite helical direction; FIG. A braided stent construction with different porosities is also disclosed in the Dubrul patent. 2001 May; 14(3):190-5. a mesh-like tube of bio-compatible material having an expanded condition in which the tube diameter is slightly larger than the diameter of the blood vessel in which it is to be implanted, and the tube length is sufficient to straddle said aneurysm and to be anchored to the blood vessel on the opposite sides of said aneurysm; said mesh-like tube also having a contracted condition wherein it is sufficiently flexible so as to be easily manipulatable through the blood vessel to straddle the aneurysm; said mesh-like tube, in its expanded condition, having a porosity index of 50%-85% such as to reduce the flow of blood through a wall of the mesh-like tube to the aneurysm sufficiently to decrease the possibility of rupture of the aneurysm but not to unduly reduce the blood flow to a perforating or branch vessel to the degree likely to cause significant damage to tissues supplied with blood by such perforating or branch vessel.
SURPASS MEDICAL LTD., ISRAEL, Free format text: 4,954,126, the contents of which are incorporated herein by reference. No. The major advantage of the endovascular procedures is that they do not require the use of open surgery.
5 illustrates a further braid pattern in which two (or more) filaments extending helically in one direction are interwoven over and under two (or more) filaments extending in the opposite direction; FIG. 1998 Dec. 10; 339(24):1725-33: International study of unruptured intracranial aneurysms investigators; Unruptured intracranial aneurysms-risk of rupture and risks of surgical intervention. Further information concerning the construction and deployment of such braided-tube intraluminal devices is available in the above-cited patents, and also in Applicant's International Application PCT/IL01/00624, published 24 Jan. 2002, International Publication No.
The development of microcatheters made possible the use of endovascular (catheter-based) procedures. Wardlaw J M, White P M. The detection and management of unruptured intracranial aneurysms.
Other difficulties are associated with the presence of preexisting thrombus within the aneurysm cavity, which may be sheared off into the parent trunk leading to parent artery occlusion. It is also possible to use combination of several filament diameters and filament materials in one device to achieve structural stability and/or desired radio-opacity characteristic.
Neurosurgery. artificial body members, parts thereof, or aids and accessories therefor, Method or apparatus for assembling prosthetic, The Regents Of The University Of California.
Also in the described preferred embodiments, the filaments, or at least most of them, are of circular cross-section and have a diameter of 10-60 m, preferably 20-40 m.
It is to be understood that the drawings and the description below are provided primarily for purposes of facilitating understanding the conceptual aspects of the invention and various possible embodiments thereof, including what is presently considered to be preferred embodiments. A further object of the invention is to provide a method of treating aneurysms by using intraluminal devices having the above features. 1997 May-June; 25(3):460-9. No. It is to be further understood that the embodiments described are for purposes of example only, and that the invention is capable of being embodied in other forms and applications than described herein. They are generally more beneficial and have much lower mortality and morbidity rates than the extravascular procedures.
Brain.
Wallsten U.S. Pat. CONFIRMATORY ASSIGNMENT;ASSIGNORS:YODFAT, OFER;LIEBER, BARUCH;GRAD, YGAEL;AND OTHERS;SIGNING DATES FROM 20091029 TO 20091102;REEL/FRAME:023564/0525, Owner name:
Nos. STRYKER CORPORATION, MICHIGAN, Free format text: A maximum porosity index is attained when the braiding angle, in the expanded condition of the braided tube, is 90. 2. 
mechanical property or material property, at different locations within the same prosthesis differing in porosity, GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS, TECHNICAL SUBJECTS COVERED BY FORMER USPC, TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS, Prosthesis, i.e.
Preferably, the braided tube has a braiding angle in the range of 20%-150% in the expanded condition of the braided tube. 8. Lieber B B, Stancampiano A P, Wakhloo A K. Alteration of hemodynamics in aneurysm models by stenting: influence of stent porosity.
Widespread, long-term experience with this technique has shown several risks and limitations. ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SURPASS MEDICAL LTD;REEL/FRAME:032223/0302. In some situations, it may be desired to implant the device in a portion of a lumen, e.g., an artery, varying significantly in diameter along its length. No abstract available.
1, FIG. For this reason the prior art has sought alternative means of treatment. 3, each filament. In the tube devices of the present invention, however, the porosity index is not more than 85%, preferably 55-80%, more preferably 60-75%.
As known, the braided tube is normally formed in an expanded condition (FIGS. In this case, the complete braided tube would have high permeability with respect to blood flow therethrough since its function is to mount the grafts, but the graft would have low-permeability to decrease the possibility of rupture of the aneurysm. Region B in FIG.
In this case the surface cross section of the filament would be in the range 75-3000 m, As indicated earlier, the windows formed in the braided tube would also be preferably within a predetermined range such as to reduce the blood-flow in the portion of the braided tube applied over the aneurysm, but maintain sufficient blood flow in any perforating or branch vessels in the vicinity of the aneurysm. 5. N Engl J Med.
The use of this technology has been limited until recently by the lack of available stents and stent delivery systems capable of safe and effective navigation through the intercranial vessels.
2. According to the present invention, there is provided an intraluminal device implantable in a blood vessel having an aneurysm therein in the vicinity of a perforating vessel, and/or of a bifurcation leading to a branch vessel, the device comprising: a mesh-like tube of bio-compatible material having an expanded condition in which the tube diameter is slightly larger than the diameter of the blood vessel in which it is to be implanted, and the tube length is sufficient to straddle the aneurysm and to be anchored to the blood vessel on the opposite sides of the aneurysm; the mesh-like tube also having a contracted condition wherein it is sufficiently flexible so as to be easily manipulatable through the blood vessel to straddle the aneurysm; the mesh-like tube, in its expanded condition, having a porosity index of 55%-80% such as to reduce the flow of blood through a wall of the mesh-like tube to the aneurysm sufficiently to decrease the possibility of rupture of the aneurysm but not to unduly reduce the blood flow to a perforating or branch vessel to the degree likely to cause significant damage to tissues supplied with blood by such perforating or branch vessel. No.
When such braided tubes are used as stents within blood vessels, the filaments forming the braided tube are generally of a diameter exceeding 50 m and define windows producing a porosity index exceeding 80%. For these reasons it is apparent that there is a need for a better intraluminal device to treat an aneurysm, particularly an intracranial aneurysm.
Nos. 8 illustrates the braided tube device, FIG. 5,061,275 and Wallsten U.S. Pat. Further, the invention could be implemented with respect to many of the other variations and applications described in the above-cited International Application PCT IL01/00624 incorporated herein by reference. According to the present invention, the filaments making up the braided tube are of a sufficiently small size in cross-section and define windows of a size such that the braided tube, when in its contracted condition, is sufficiently flexible so as to be easily manipulatable through the blood vessel to straddle the aneurysm; and when in its expanded condition straddling the aneurysm, reduces the flow of blood through the braided tube to the aneurysm sufficiently to decrease the possibility of rupture of the aneurysm. Another object of the invention is to provide an implantable intraluminal device for treating aneurysms in the intracranial vasculature that is sufficiently flexible and pliable so that it can be delivered easily to an intracranial site, deployed accurately, and then left in position to accomplish its purpose. In approximately 15,000 cases (6 cases per 100,000 persons per year), intracranial aneurysms rupture every year in North America [2].
No. Preferably, the filaments are made of a material selected from among the 316L stainless steel, tantalum, and super elastic Nitinol, cobalt base alloy, polymer or any other suitable metal or metal combination. As will be described more particularly below, intraluminal devices constructed in accordance with the foregoing features show great promise in the treatment of aneurysms in general, and brain aneurysms in particular, since they are relatively easily manipulatable through the blood vessel to the implantation site, and when deployed in their expanded condition in the implantation site, they reduce the flow of blood to the aneurysm sufficiently to decrease the possibility of rupture thereof, while maintaining patency in any perforating or branch vessels in the vicinity of the aneurysm. intravascular implant expansion deflector. These problems were sought to be overcome in the above-cited McCrory U.S. Pat.
The intraluminal device includes a mesh-like tube of bio-compatible material having an expanded condition in which the tube diameter is slightly larger than the diameter of the blood vessel in which it is to be implanted, and the tube length is sufficient to straddle the aneurysm and to be anchored to the blood vessel on the opposite sides of the aneurysm. Such braided-tube intraluminal devices are well-known, for example as described in Wallsten et al, U.S. Pat.
4,954,126, and Dubrul U.S. Pat. The invention also relates to methods of treating aneurysms using such intraluminal devices. The filament diameters in this region would be significantly smaller than in region A, preferably being 10-60 m, more preferably 20-40 m. J Neurosurg. Both of these surgical procedures typically require general anesthesia, craniotomy, brain retraction, and dissection of the arachnoid around the neck of the aneurysm.
The circumference can be enlarged micro-scale by adding roughness to the wire, in order to control the neointimal growth and making the circumference in micro scale longer while keeping the macro scale the same. An object of the present invention is to provide an intraluminal device having advantages in one or more of the above respects for implantation in a blood vessel having an aneurysm in order to treat the aneurysm.
No.
In the interest of clarity and brevity, no attempt is made to provide more details than necessary to enable one skilled in the art, using routine skill and design, to understand and practice the described invention. One of the disadvantages of this method is that detachable balloons, when inflated, typically do not conform to the interior configuration of the aneurysm sac. No. 4,954,126, discloses a braided tube intraluminal device for use in various applications, one of which applications is to apply a graft to treat an aneurysm (FIG.
mechanical property or material property, at different locations within the same prosthesis, Special features of prostheses classified in groups A61F2/00-A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. Assignors: GRAD, YGAEL, LIEBER, BARUCH, NISHRI, BOAZ, YODFAT, OFER, Assignors: MINDGUARD LTD. (IN VOLUNTARY LIQUIDATION), Assignors: GRAD, YGAEL, NISHRI, BOAZ, LIEBER, BARUCH, YODFAT, OFER, https://patents.darts-ip.com/?family=26910931&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20030100945(A1). The blood vessels in the brain are frequently as small as several millimeters, requiring that the catheters have an outside diameter as small as 2-8 French (0.66 mm to 2.64 mm). Preferably the length of the window, i.e., its long dimension as shown at W. The diameter and length of the braided tube in its normal, expanded condition, will vary according to the location and anatomical dimensions at the particular site of the implantation. WO 02/05729, the contents of which are incorporated herein by reference. The present invention is related to Provisional Application No. Delivery devices for stents for use in the intracranial vasculature are well known at the art. The present invention relates to intraluminal devices implantable in a blood vessel for the treatment of aneurysms especially brain aneurysms.
Thus, shown in FIG. Instead, the aneurysm sac is forced to conform to the exterior surface of the detachable balloon.
10 illustrates the variation wherein the opposite ends of the braided tube.
Preferably the braid is formed of 24-144 filaments, more preferably 62-120 filaments.
An intraluminal device implantable in a blood vessel having an aneurysm therein in the vicinity of a perforating vessel and/or of a bifurcation leading to a branch vessel.
This problem can be easily overcome in several ways, e.g., by creating braided devices with variable diameters along their longitudinal axis, as described in the above-cited International Publication No. It is possible to use a combination of several filament materials in one device and combinations of several materials in one filament. An International Study of Unruptured Intracranial Aneurysms Investigators. In the described preferred embodiments, the mesh-like tube includes windows having an inscribed diameter of 30-480 m, preferably 50-320 m, in the expanded condition of the mesh-like tube. Another surgical procedure is to surgically reconstruct the aneurysmal portion of the artery, by surgically cut out the aneurysm and repairing the vessel by using a natural or synthetic vessel graft. A steady flow analysis on the stented and non-stented sidewall aneurysm models. 1999 April; 21(3):133-41.
When the stent is deployed, the portion of low permeability is located to overlie the neck of the aneurysm, and the portion of high permeability is spaced from the neck of the aneurysm. They are generally used as stents for providing support to a wall of a blood vessel, for implanting a graft, e.g., to treat an aneurysm (FIG. The relatively low success rate is due to technical limitations (e.g., coil flexibility, shape, and dimensions) which prevent tight packing of the sac of the aneurysm, especially aneurysms with wide necks [3]. 60/332,013 filed 23 Nov. 2001, the contents of which are incorporated herein by reference, and claims the priority date of that application. 2000 November; 31(11): 2742-50. Lanzino G, Wakhloo A K, Fessler R D, Hartney M L, Guterman L R, Hopkins L N. Efficacy and current limitations of intravascular stents for intracranial internal carotid, vertebral, and basilar artery aneurysms. However, decreasing the braiding angle below 90 increases the radial force applied by the braided tube against the inner surface of the blood vessel and decreases the P.E. At the present time, three general methods of treatment exist.
Brown et al, on the other hand, discloses an intraluminal device or stent comprising a diverter, in the form of a low-permeability foam pad, to overlie the neck of the aneurysm, straddled on its opposite sides by a pair of high-permeability coil elements for anchoring the device in the blood vessel. 7 diagrammatically illustrates the braided tube device, therein generally designated, Thus, FIG. Ann Biomed Eng.
Autopsy studies show that the overall frequency of intracranial aneurysms in the general population is approximately 5 percent and suggest that 10 to 15 million persons in the United States have or will have intracranial aneurysms [1].
Thus, there is an increased risk that the detachable balloon will rupture the sac of the aneurysm. No. bladders, tracheae, bronchi or bile ducts, Modifying the blood flow model, e.g. Occlusion system for endovascular treatment of an aneurysm, Removable occlusion system for aneurysm neck, Methods and devices for the treatment of aneurysms, Method for culturing cells using wave-induced agitation, Filter and method for trapping emboli during endovascular procedures, Variable stent and method for treatment of arterial disease, Expandable stent having radiopaque marker and method, Stent-graft with bioabsorbable structural support, Implantable cerebral protection device and methods of use, Methods for recovering polypeptides from plants and portions thereof, Removable vascular filter, catheter system and methods of use, Intra-luminal device for treatment of body cavities and lumens and method of use, Tooth enamel remineralization accelerator, oral composition and food and drink, Method and apparatus for aseptic growth or processing of biomass, Porous synthetic vascular grafts with oriented ingrowth channels, Disposable bioreactor for culturing microorganisms and cells, Woven bifurcated and trifurcated stents and methods for making the same, Woven intravascular devices and methods for making the same and apparatus for delivery of the same, Implantable composite device and corresponding method for deflecting embolic material in blood flowing at an arterial bifurcation, Implantable integral device and corresponding method for deflecting embolic material in blood flowing at an arterial bifurcation, Devices and methods for preventing distal embolization from the internal carotid artery using flow reversal by partial occlusion of the external carotid artery, Bioactive aneurysm closure device assembly and kit, Composite expandable device with impervious polymeric covering and bioactive coating thereon, delivery apparatus and method, Method and apparatus for supporting a graft assembly, Methods and devices for protecting a passageway in a body when advancing devices through the passageway, Micro-porous mesh stent with hybrid structure, Aneurysm liner with multi-segment extender, Expression of biologically active polypeptides in duckweed, Technology for manufacturing sole of heavy shoe, Stent devices with detachable distal or proximal wires, Implantable composite stroke preventing device and method of manufacturing, Deployment system for implantable self-expandable intraluminal devices, Implantable expanding stroke preventing device and method of maufacturing, Self furling umbrella frame for carotid filter, Expandable delivery appliance particularly for delivering intravascular devices, Implantable intraluminal protector device and method of using same for stabilizing atheromas, Composite stent with polymeric covering and bioactive coating, Stretch-resistant vaso-occlusive assembly with multiple detaching points, Braided intraluminal device for stroke prevention, Measurements in a body lumen using guidewire with spaced markers, Human lysosomal proteins from plant cell culture, Methods for expression of enzymatically active recombinant lysosomal enzymes in transgenic plant root cells and vectors used thereby, Method and apparatus for making intraluminal implants and construction particularly useful in such method and apparatus, Delivery system for self-expandable diverter, Implantable medical devices with enhanced visibility, mechanical properties and biocompatability, Mixed wire braided device with structural integrity, System and method for supplying and deploying an occlusion device in a conduit, Partially covered stent devices and methods of use, An endovascular device with membrane having permanently attached agents, Aneurysm covering devices and delivery devices, Production of high purity decabromodiphenylalkanes, System and method for intracranial access, Production of high mannose proteins in plant culture and therapeutic uses thereof, Stent apparatuses for treatment via body lumens and methods of use, Stent assembly and methods for treatment via body lumens, Intravascular aneurysm treatment device and methods, Optimized stent jacket having single fiber mesh, Methods of providing optimized drug-eluting stent assemblies, Optimized drug-eluting stent assembly methods, Methods for attaining a predetermined porosity of a vascular device, Coated vaso-occlusive device and methods for treatment of aneurysms, Methods of coupling parts of vascular treatment systems, Methods of manufacturing vascular treatment devices, Methods of manufacturing woven vascular treatment devices, Methods of using non-cylindrical mandrels, Methods of manufacturing slotted vascular treatment devices, Variably bulbous vascular treatment devices, Longitudinally variable vascular treatment devices, Methods of selectively heat treating tubular devices, Methods of manufacturing flow diverting devices, Two-way shape memory vascular treatment methods, Methods of manufacturing variable porosity flow diverting devices, Two-way shape memory vascular treatment systems, Thrombus aspiration using an operator-selectable suction pattern, Methods of treating a thrombus in a vein using cyclical aspiration patterns, Methods of treating a thrombus in an artery using cyclical aspiration patterns, Circumferentially offset variable porosity devices, Methods of manufacturing variable porosity devices, Thrombus aspiration with different intensity levels, Systems for aspirating thrombus during neurosurgical procedures, Aneurysm treatment device and method of use, Self expanding bifurcated endovascular prosthesis, Methods and apparatus for stenting comprising enhanced embolic protection coupled with improved protections against restenosis and thrombus formation, Stent with variable cross section braiding filament and method for making same, Articulated expandable intraluminal stent, Stent for treating bifurcate vessel and stent graft, Information on status: application discontinuation. 3 is of highest flexibility, whereas that illustrated in FIG. 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FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. 
