Stent graft prothesis

Abstract

To provide a prothesis device which can be arranged in a natural blood vessel.SOLUTION: A stent graft prothesis which repairs a deficit natural blood vessel includes a tubular fabric member having a first end and a second end. At least one of the ends is supported by a combination of two cooperating ring stents having different configurations. The tubular fabric member is attached to the ring stents at the time of being selected. At least one of the ring stents can be compressed in a folded "saddle" shape having two projections and two recesses. The other of the ring stents crosses at four points on the "saddle" shaped ring stent. Each of the points are in a region between the projection and recess of the folded "saddle" shape. When developed, the other ring stent is selected from a ring stent provided with one or more of a circular or cylindrical shaped, or a saddle shaped, or a V-shaped hinge part having a curved part therebetween.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to a method for treating a patient's natural vascular deficiency due to disease, injury, or the natural aging process. Targeted therapeutic sites within the lumen of native blood vessels to compensate for the reduced ability of the blood to perform essential functions. In particular, the present invention relates to a prosthetic device that can be placed at a target treatment site. An improved method of fastening is disclosed. [Background technology]

[0002] Artificial prostheses consisting of tubular conduits having open lumens are well known and can be surgically inserted. and hybrid surgical procedures. Currently, prostheses are placed at the treatment site inside the body. For example, blood vessels or other hollow organs such as the bile duct, intestinal segments, etc. In appropriate cases, minimally invasive delivery systems may be used to replace damaged natural body cavities. The most common use of such prostheses is The primary goal of vascular endovascular treatment is to replace diseased or damaged blood vessels.

[0003] Some vascular disorders can be treated with the use of artificial prostheses Dissection, a tear or separation of the lining of a natural blood vessel such as the aorta, is one such injury. For example, in an aortic dissection, the lining of the aorta separates from the media, causing blood to flow rapidly through the tear. The inflow of oxygen can cause the detachment to progress, blood vessels to expand unnaturally, and / or blood leakage ( This can cause blood to leak between the layers of the blood vessels, rupturing the aorta or or blood flow may be diverted, resulting in insufficient blood flow to the organ (ischemia).

[0004] Another relatively common vascular disorder is the aneurysm. Aneurysms typically occur in the natural artery of the aorta. They occur when a portion of the blood vessel wall expands and bulges outward. Small aneurysms are rarely, if ever, Although they do not cause any symptoms, large aneurysms pose a great danger to the patient. Rupture of the aorta can occur without warning and is usually fatal, so early diagnosis and Treatment is important. With an aging population, the incidence of aneurysms continues to rise in Western societies. is.

[0005] If an aneurysm is diagnosed before it ruptures, surgical treatment to repair the affected blood vessel wall is effective. Surgical treatment of aneurysms involves a large procedure under general anesthesia that allows the patient's abdomen or thorax to be opened. The aneurysmal site of the artery is replaced or reinforced with a synthetic graft or prosthesis (Non-Patent Document 1 (See ). Patients then have a normal life expectancy.

[0006] Currently, aneurysms or dissections are repaired using fabric or ePTFE grafts placed through a catheter. In many cases, the stent is delivered by a catheter and held in the required position by deploying a metallic stent element. The graft / stent can be delivered by catheter, eliminating the need for surgical intervention. Entry requires only a small incision to expose the femoral artery. Under appropriate circumstances, the device can be inserted into the It can be deployed percutaneously. Catheter delivery is preferred for localized delivery, as it is a less invasive procedure. Catheter delivery is therefore associated with reduced mortality and morbidity. For example, endovascular repair is typically performed in patients with renal failure. It is used to treat abdominal aortic aneurysms below the kidneys by placing a graft under the artery. Many different types of devices are available that are useful for endodontic repair.

[0005] The elastically engaging intravascular element described in US Pat. No. 5,399,633 (Medtronic) or US Pat. No. 5,499,633 (Medtronic) The radially expandable support frame and the radiation-resistant sewn into the liner are described in There is a tubular fabric liner having a transparent marker element.

[0007] Intravascular techniques involve delivery of the prosthesis by catheter. The inner lumen of the catheter Defines the maximum dimensions of the prosthesis to be inserted, so that it can be packaged in the smallest possible volume. Great effort has gone into designing a prosthesis that can be easily deployed once in place and in the required location. Power has been expended.

[0008] One successful type of prosthesis is attached to a rigid support or stent. A "stent graft" includes a conduit formed from a flexible sleeve. Typically, expanded polytetrafluoroethylene (ePTFE), PTFE or polyester Physiologically acceptable fabrics (usually knitted or woven fabric) that optionally reduces friction, inhibits clotting, or delivers pharmaceutical agents. Coatings for fabrics or their constituent fibers include , heparin, gelatin, collagen, or antibacterial agents such as rifampicin. The substrate should be porous on at least one surface to allow for cellular ingrowth. These materials are suitable for the presently disclosed stent graft prosthesis. The stent can be balloon expandable (e.g., a rigid stainless steel wire). However, the stent is self-expanding and They can also be made from shape-memory materials such as Knole (a nickel-titanium alloy). Stent designs that can be used for this purpose are known in the art. For example, the braided stent described in US Pat. tents, or wire "zig-zag" stents as described in U.S. Patent No. 5,399,633. In addition, the stent design can be designed to be delivered by radial or axial deformation, or a combination of both. The catheter is then temporarily retained using a removable sleeve or release wire. It addresses the requirements for compact packaging for a rugged configuration.

[0009] Another useful design is a "wire-based" ring stent that can be formed into individual circular ring stents. A ring stent with a "saddle" shape. It is usually flat (different from the natural ring). (not distorted), a first pair of diametrically opposed points on the circumference of the ring stent are distorted in one axial direction. The first pair has sufficient elasticity to bend (fold) into its desired position. A second pair of diametrically opposed points, located at the center, are displaced in opposite axial directions to form a symmetrical "strip." For convenience, the first pair of points will be described as a "mountain" and the second pair of points will be described as a "dollar" shaped configuration. Peaks and valleys can be described as "peaks" and "valleys," or vice versa. Typically, the first pair of points are fixed to a tubular sleeve component of the graft prosthesis. The degree of axial displacement between the second pair of points (this axial displacement is also called the "saddle height"). The original circumference of the ring stent before it is distorted (folded) is shown in Fig. 1. is a function of the final circumference of a circle that the (dollar-shaped) configuration can be placed inside. The ratio of the final circumference to the original circumference can be used to simplify the axial displacement. The circumference is the outer circumference of the graft sleeve to which the stent is attached. The oversize ratio of the undistorted inner circumference of a circular stent to the outer circumference is taken It is also a convenient measure of the "saddle" shape and can be calculated as follows:

number

[0010] [Patent Document 1] U.S. Patent No. 6,635,080 [Patent Document 2] U.S. Patent No. 6,203,568 [Patent Document 3] European Patent No. 880979 [Patent Document 4] U.S. Patent No. 4,580,568 [Non-patent literature]

[0011] [Non-Patent Document 1] Parodi et al., Annals of Vascular Surgery (1991) 5: 491-499. Summary of the Invention

[0012] A stent graft prosthesis for repairing a defective natural blood vessel includes at least a first end and and a second end, at least one of the ends being of a different configuration. The tubular fabric member is supported by a combination of two cooperating ring stents. At least one of the rings is attached to each of the ring stents at a selected point. The stent can be compressed into a folded "saddle" shape with two peaks and two valleys. The other ring stent crosses over the "saddle" shaped ring stent at four points. Each point lies in the area between the peaks and valleys of the folded "saddle" shape. When deployed, the tent may be circular, cylindrical, or saddle-shaped, or any curve in between. a ring stent having one or more V-shaped hinge portions having a portion; or A "Z" shaped stent may be selected.

[0013] In particular, the stent graft prosthesis disclosed comprises: At least a first end and a second end, and a length L extending between the first end and the second end f and , open lumen diameter D f and a tubular fabric member having a At least one of the first end and the second end of the tubular fabric member is provided with two cooperating tubular members of different configurations. The stent is supported by a combination of rings and stents. Each of the stents is preferably stent-grafted to provide a compact delivery configuration for the stent-graft prosthesis. The tubular fabric member is compressible into a folded configuration for compressing the tubular fabric member into two cooperating configurations. Each ring is attached at a selected point to the stent. At least one of the ring stents is a folded stent having two peaks and two valleys. The other of the two cooperating ring stents of different configurations is , intersecting at four points on at least one of two cooperating ring stents of different configurations Each point lies in the region between the peaks and valleys of the folded "saddle" shape.

[0014] The stent graft prosthesis is comprised of two cooperating ring stents of different configurations. , which can be compressed into a folded "saddle" shape with two peaks and two valleys, The peaks are axially aligned with the peaks of at least one of two cooperating ring stents of different configuration. It can be configured to be in line.

[0015] The stent graft prosthesis consists of two cooperating stents of different configurations that can be compressed into a collapsed shape. The other of the ring stents that operates on the stent has at least one "V" shaped hinge portion. The "V" shaped hinged ring stent has two different configurations. and configured to be axially aligned with the crests of at least one of the cooperating ring stents. It is possible.

[0016] Disclosed herein is a stent graft prosthesis that includes: At least a first end and a second end, and a length L extending between the first end and the second end f and , a tubular fabric member having a length L f is a continuous tubular fabric portion aligned with the longitudinal axis of the tubular fabric member. The longest dimension of the tubular fabric member is the open lumen diameter D f The first tubular fabric member At least one of the end and the second end is of two cooperating ring stents of different configurations. The combination is supported by two cooperating ring stents of different configurations. compactly packages a stent-graft prosthesis for delivery into the lumen of a blood vessel The tubular fabric member can be optionally compressed into a folded shape for the purpose of folding. The two cooperating ring stents in the configuration may be the same or different. The stent may be supported over its entire length by one or more additional stents. In particular, the second end portion may be disposed at an intermediate position or spaced apart from the first end portion. Any of the additional stents or combinations thereof that may be used in the stent graft process may be used. When the prosthesis is fully deployed and the lumen of the tubular fabric member is open, two different configurations of In the cooperating ring stent combination, two cooperating ring stents of different configurations are used. Alternatively, for use in natural blood vessels, the tubular Two cooperating elements of different configurations disposed at the first end or the second end or at each end of the fabric member. The ring-stent combination is used to support the tubular graft member within its length. It does not engage with any other additional stents that are used and does not interfere with such other additional stents (if present). The tubular fabric member may be provided with a plurality of different The combination of two cooperating ring stents in the configuration allows the stent graft prosthesis to The catheter is adapted to maintain a desired open, circular configuration when deployed in an operational configuration within the lumen of a vessel. This can be seen, for example, when using a single steep saddle-shaped ring stent. Thus, it acts to counteract the tendency of the open end to distort, ovalize, or flatten. The term "steep" refers to a material that, when folded into a saddle shape, extends in one direction, e.g. The grooves have a significant axial distance between the peaks and valleys extending in the opposite axial direction. This applies to ring stents that have "peaks" and "valleys" that correspond to each other.

[0017] The term "combination of two cooperating ring stents of different configurations" means a combination of two individual The functional relationship between the two ring stents is as follows: The present invention relates to a method for manufacturing a tubular graph comprising: As a result, the two The ring stents interact and are not bonded together while the stent graft prosthesis is The ring stent improves the position and radial stability of the stent. overlap across the intersecting portions during folding and deployment of the tent graft prosthesis; or sliding. Combination of two cooperating ring stents of different configurations The interaction between the ring stents is such that each ring stent is attached to the tubular groove of the stent graft prosthesis. This can be facilitated by selectively attaching the ends of the raft members.

[0018] The combination of two cooperating ring stents of different configurations may be deployed in a circular or Collapsible ring stent having a cylindrical shape, foldable to have a saddle shape when deployed A ring stent that can be inserted into the stent and one or more V-shaped stents with curved sections between them. A ring stent selected from a foldable ring stent having a hinge portion. However, the above combination of two cooperating ring stents of different configurations may be used. In the set, only one collapsible ring stent may be circular or cylindrical. Multiple stents connected together as one of two cooperating ring stents of different configurations. In the case of a foldable ring stent having a "V" shaped hinge portion, the type The ring stent may be referred to as a "Z" shaped stent. When deployed, it forms a saddle The collapsible ring stent has a configuration in which the deployed configuration forms a steeply saddle shape. Ring stents selected from those that form a gentle saddle shape to those that form a gentle saddle shape As used herein, the term "steep" The ring stent is used in combination with two cooperating ring stents of different configurations. One of the folded ring stents is useful for comparing the The ring stent is folded and constrained against the other ring stent or in the deployed state. In combination of two cooperating ring stents of different configurations, one in relation to the other In contrast, ring stents can be considered to be distinct.

[0019] The combination of two cooperating ring stents of different configurations is One of the ring stents crosses the other of two cooperating ring stents of different configurations. Thus, the present invention includes a ring stent having two cooperating ring stents of different configurations. One of them can be considered to be inside the other, or one can be considered to be an outer ring state. The outer ring is generally the stent graft. The end of the prosthesis is then properly sealed in its desired position, e.g. by using a healthy natural blood vessel. It also performs a sealing function to hold the fabric of the tubular fabric member against the surface of the desired portion. Generally, the inner ring is configured to have an open lumen that is expanded, e.g., flattened, ovalized, petal-shaped, elongated, etc. To resist expansion or tubing at the deployed end of the stent graft prosthesis If the lumen is distorted from its designed configuration in one transluminal dimension or another, To inhibit any tendency of the tubular fabric member of the stent graft prosthesis to It serves to ensure shape retention, particularly radial stability, for the shape.

[0020] The following illustrative, but not exhaustive, list is intended to Different configurations of the prosthesis are useful for positioning and stabilizing at least one end of the prosthesis. 1 shows an embodiment of a combination of two cooperating ring stents. The ring stent has an outer non-steep saddle shape and an inner steep saddle shape. Gusten. The ring stent consists of an outer circular or cylindrical ring stent and an inner steeply saddle-shaped ring stent. nt. The ring stent has an inner non-steep saddle shape and an outer steep saddle shape. Gusten. The ring stent consists of an inner circular or cylindrical ring stent and an outer steep saddle-shaped ring stent. nt. An internal shaped ring having at least one "V" shaped flexible hinge portion A stent having a curved portion on both sides of at least one configured "V" shaped portion. A ring stent having more than one "V" shaped flexible hinge section at the side or between the sections. and an external non-steep saddle-shaped ring stent. An internal shaped link having at least one "V" shaped flexible hinge portion. a curved portion of the stent having at least one pre-configured "V" shaped portion; Ring steel with two or more "V" shaped flexible hinge sections on either side and an external circular or cylindrical ring stent. An external steep saddle-shaped ring stent and an internal radially compressible Z-stent . External circular or non-steep saddle shaped ring stent and internal radially compressible Z stent.

[0021] Disclosed herein is a stent graft prosthesis comprising: At least a first end and a second end, and a length L extending between the first end and the second end f and , open lumen diameter D f and a tubular fabric member having At least one of the first end and the second end of the tubular fabric member is provided with two cooperating tubular members of different configurations. The stent is supported by a combination of two cooperating ring stents of different configurations. Each of the tents is folded to deliver the stent graft prosthesis to the treatment site. The tubular fabric member is compressible into a shape that is substantially parallel to the surface of the stent. The two cooperating ring stents are of different configurations and are attached at selected points. One of the ring stents crosses the other of two cooperating ring stents of different configurations. The different configurations of the ring stents are different in that one of the two cooperating ring stents is The structure is such that the stent is restrained from overexpansion by the other of two cooperating ring stents of different configurations. Includes composition.

[0022] Different configurations of the two cooperating ring stents may be used. One side of the tent is a relatively steep "saddle" shaped ring, with two collaborating tent poles of different configurations. The stent can include a configuration in which the stent is restrained from over-expansion by the other of the ring stems acting thereon.

[0023] Different configurations of the two cooperating ring stents may be used. One side of the tent is a relatively steeply shaped ring, and the other is a shallower (shaped The latter may include a feature that restrains a ring stent (not shown) from overexpanding. This is the other of the two cooperating ring stents in the configuration.

[0024] In an embodiment, in a combination of two cooperating ring stents of different configurations One of the two cooperating ring stents of different configurations is the ring stent as follows: That is, the stent graft prosthesis may be fully deployed and the tubular fabric portion may be The lumen of the material when open may be substantially circular or may have two cooperating Two cooperating ring stents of different configurations, each of which is less steep than the other of the ring stents. A ring stent is a stent that is external to the other stent. The other of the stents may be in the shape of a relatively steep saddle. A circular or less steep ring stent in configuration, when deployed, It serves as the primary sealing ring for the end of the stent graft prosthesis.

[0025] In an embodiment, one or more ring stents are configured to be inflated with the aid of an expandable balloon. It can be expanded.

[0026] The ring stent in the combination of two cooperating ring stents of different configurations is It may be formed from a shape memory material and folds compactly to accommodate the desired use. The catheter may be capable of returning to a compact shape for delivery, e.g., within a constraining delivery sheath. This facilitates folding the device into a compact package, e.g., by removing the constraining delivery sheath. When deployed by the stent, each ring of the combination of two cooperating ring stents of different configurations The stent graft prosthesis is then opened and extends within the constraints of the attached tubular fabric member and the stent graft prosthesis. The desired configuration may be achieved within any additional constraints imposed by the natural vasculature in which the thesis is deployed. There is a tendency to adopt

[0027] Desired configuration of compressible ring stents in deployed stent graft prostheses The configuration may, for example, be such that the stent graft prosthesis is packaged within a constraining delivery sheath. The ring stent is preattached to the tubular fabric member at selected discrete points by pre-suturing. The attachment can be secured after the restraining delivery sheath has been removed.

[0028] At least one ring in the combination of two cooperating ring stents of different configurations The stent expands radially from a compact configuration to a circular or partially cylindrical configuration. The combination of two cooperating ring stents of different configurations can be At least one ring stent, which may be radially expandable, may include one Or it may have multiple V-shaped hinge sections and curved sections between them. Alternatively, in combination with two cooperating ring stents of different configurations, radially At least one ring stent, which may be expandable, is a "Z" shaped stent. The hinge may have multiple "V" shaped hinge portions connected together to provide Cut.

[0029] At least one ring stent in a combination of two cooperating ring stents The ring stent may be a "saddle-shaped" ring stent. When folded into a compact configuration or deployed into an expanded configuration, Moves in both radial directions.

[0030] Radially expandable in combination with two cooperating ring stents of different configurations The ring stent is placed within a "saddle-shaped" ring stent and tubular at selected points. This configuration allows the "saddle-shaped" ring stent to be attached to the tubing. The saddle-shaped member is supported by a support member that is supported by a support member that supports the support member. The desired "ring-like" stent shape is observed due to flattening of the open ends of the tubular fabric member. Suppression of what the industry calls "petalization" or "ellipticalization" of open circular configurations do.

[0031] In an embodiment of the stent graft prosthesis, at least one "V" shaped hiatus is provided. The shape-set ring stent with a flex portion is constructed of two cooperating rings of different configurations. The stent is at least partially disposed within the other of the two cooperating links of different configurations. The other side of the stent is compressible into a "saddle" shape having peaks and valleys. Shape-set ring stents are held together by a "V" shaped hinge or by a set of shapes. Each "V" shaped hinge of the configured ring stent creates a "saddle" shaped ring. The tubular fabric member is attached to the fabric by the peaks of the stent.

[0032] In an embodiment of the stent graft prosthesis, the tubular fabric member has a first end and a second end. A ring stent having a substantially circular perimeter at each end. is attached to the fabric of the tubular fabric member at a plurality of points around one of the first end and the second end. The cooperating shape set ring stents are attached to the fabric portion of the tubular fabric member at the same end. A ring that can be selectively attached and compressed into a "saddle" shape having peaks and valleys A stent may be used to compress a stent graft prosthesis for delivery to the lumen of a native blood vessel, for example. The stent graft prosthesis is deployed within the lumen of the native vessel or while being folded to contract. During deployment, the stent may be slid over the shaped ring stent as needed. do.

[0033] The combination of two cooperating ring stents with different configurations provides important vascular support for long-term implantation. Effective end sealing and radial stability with migration-resistant function for endograft prostheses has been shown to provide

[0034] A shape design having one or more V-shaped hinge portions and a curved portion therebetween. The foldable ring stent is formed into a folding ring having two peaks and two valleys. Its use in combination with an outer ring stent that can be compressed into a folded "saddle" shape is A combination tubular fabric member of a stent graft prosthesis deployed as a repair in a natural blood vessel. The present invention provides a stent with two peaks and two valleys. The "end ring stent" is configured as an outer ring stent on top of the other, and has a shape The collapsible ring stent is slidably intersected with a portion of the stent, thereby forming a stent. During deployment of the graft prosthesis, the shape-set ring stent moves radially and It expands perpendicular to the wall of the native vessel being repaired. This radial expansion creates an outer "saddle" Prevents the end ring stent from distorting into a so-called "petal" shape or "ovalization" deformation. While still holding the stent in place, the "saddle" shaped ring stent is urged into the desired circular cross-sectional shape.

[0035] Alternatively, each ring in a combination of two cooperating ring stents may be of different configurations. The stents can be of the "saddle-shaped" type and have different saddle heights. do.

[0036] According to one embodiment of the stent graft prosthesis, a first end and a second end of the tubular fabric member are Each end is supported by a ring-stent combination. Each tent combination consists of two cooperating ring stents of different configurations. Optionally, the continuous tubular fabric member extending between the first end and the second end is spaced apart. The tubular fabric member is supported by a ring stent. It does not have to be the same as a ring-stent combination with end support.

[0037] The first and second ends of the tubular fabric member are referred to herein as the "proximal" and "distal" ends. The stent graft is located in a stent graft section that is closer to the heart when deployed and farther from the heart when deployed, respectively. The term "prosthesis" refers to the end of the prosthesis.

[0038] In one embodiment of the stent graft prosthesis, the stent graft prosthesis comprises: In each ring-stent combination, the outer "saddle" shaped ring stent, The ring stent is a simple circular stent that overlaps and constrains an inner, steeper "saddle" shaped ring stent. The self-expanding ring stent is used to measure the radial expansion force of the self-expanding ring stent. This addresses the potential problem of long-term vascular overdilation caused by overlapping rings. The stent combination also has an inner ring stent exerting a radially directed force, A sealing member is provided to securely hold the outer ring stent and the fabric of the tubular fabric member against the vessel wall. The result was that the ring stent deployed against the vascular wall was placed in a good parallel position for the purpose of Brings results.

[0039] In an embodiment, two cooperating rings of different configurations are compressible into a folded shape. Each of the stents is compressible into a "saddle" shape having peaks and valleys. One of the cooperating ring stents has an open lumen diameter D of the tubular fabric member. f More than compressed No diameter d 1 The other of the two cooperating ring stents has an open lumen of a tubular fabric member. Diameter D f and has a diameter d 1 The uncompressed diameter d is significantly larger than 2 Have One of the two cooperating ring stents having an uncompressed diameter d1 is Unknown diameter d 2 The ring stent is attached to the other of the two cooperating ring stents. In such an embodiment, the uncompressed diameter d 1 One of the two cooperating ring stents has four intersections, which are not compressed. Diameter d 2 Typically, two cooperating ring stents having a crossover are intersected over each other. The difference is the uncompressed diameter d 2 In the region between the peaks and valleys of the ring stent having be.

[0040] In such an embodiment, the uncompressed diameter d 1 Two cooperating phosphorus One of the stents was designed as a ring stent (LS) with a "less steep saddle" shape. Identify the uncompressed diameter d 2 The other of the two cooperating ring stents having It can be identified as a "steep saddle" shaped ring stent (S).

[0041] In an embodiment, the stent graft prosthesis is branched, e.g., bifurcated. It is possible.

[0042] Those skilled in the art will appreciate that the tubular fabric member functions as a repair sleeve or liner. a first end that extends through and connects to a weakened or missing portion of a natural blood vessel; and a stent disposed at the second end to fill a weakened or defective portion of the native blood vessel. The tubular fabric member is deployed after the treatment procedure is completed and the components of the delivery system are removed. The tubular fabric member functions to position the tubular fabric member so that the tubular fabric member is inserted into the endoscopic device after the treatment procedure is completed. a first end and a second end, which function to position the tubular fabric member so that the These stents have at least one different end, as claimed. As long as the stent has two cooperating rings of the same design or construction, stomach.

[0043] In an embodiment, each of the two cooperating ring stents of different configurations comprises a tubular fabric member At least one portion is attached to the fabric. Two cooperating rings of different configurations Each of the ring stents is in sliding contact with the other portion of two cooperating ring stents of different configurations. Thereby, two cooperating rings of different configurations are Each of the stents can be folded and deployed according to its characteristics. While the tubular fabric body is formed by the overlapping portions of two cooperating ring stents of different configurations. The end profile and shape of the stent graft prosthesis are improved. The performance of the system is improved.

[0044] In its initial state, i.e., before being folded, the ring stent is conveniently referred to herein as A circle that has its widest lateral dimension, called the diameter, and may be completely undeformed shaped ring, or flexible hinge section or sinusoidal section (as disclosed herein below) A ring having at least one, preferably two, shaped portions such as a circular ring. It will be understood that the collapsed state may allow the stent to pass through the narrow lumen of a tubular blood vessel. The catheter may be compacted for delivery purposes within a delivery restraint such as a sheath in which the “diameter” is reduced to allow delivery of the catheter to a compact size. In such a compact folded state, At least one sinusoidal portion of the ring stent is in the longitudinal direction of the tubular fabric member. Therefore, the "diameter" of the ring stent can be displaced axially along the axis of the ring stent. The tubular fabric portion is folded into its original unfolded shape. Compact for delivery into a restraining device such as a removable sheath attached to the material. The graft prosthesis is in a shape that is curved or supports the open end of the tubular graft prosthesis in the lumen of the blood vessel. It is necessary to consider whether the deployment configuration is one in which the

[0045] Shape setting of "shape memory" materials is generally known. This shape setting usually involves a heat treatment. Under the treatment process, in the case of the wire-formed ring of the present invention, a cylindrical or polygonal mandrel is formed. It involves the manipulation of material around a shape former, a dorel. It involves a heating and quenching phase. For example, U.S. Patent Application Publication No. 2009 / 0136664 may include the controlled, continuous application of No. 0309273 discloses a method for making a self-expanding tubular stent from a shape memory alloy. do.

[0046] In an embodiment, in a combination of two cooperating ring stents of different configurations At least two cooperating ring stents of different configurations compressible into a collapsed configuration. The other is the open lumen diameter D of the tubular fabric member. f The uncompressed diameter is greater than .

[0047] In an embodiment, in a combination of two cooperating ring stents of different configurations Each of the two cooperating ring stents of different configurations is compressible into a collapsed configuration, Open lumen diameter D of tubular fabric member f or the open lumen diameter D f More than 100% compressed The diameter is not

[0048] In an embodiment, in a combination of two cooperating ring stents of different configurations One of two cooperating ring stents of different configurations compressible into a collapsed configuration is folded Two cooperating ring stents of different configurations that are compressible into a collapsed configuration have a diameter that exceeds that of the other. It has a diameter of

[0049] Each of the two cooperating ring stents of different configurations compressible into a collapsed configuration includes: It is compressible into a "saddle" shape with peaks and valleys. Two cooperating ring steels One of the two (LS) is the open cavity diameter D of the tubular fabric member. f Uncompressed diameter d or more 1 Have The other of the two cooperating ring stents (S) has an open lumen diameter D of the tubular fabric member. f and has a diameter d 1 The uncompressed diameter d is significantly larger than 2 has. Uncompressed diameter d 1 One of the two cooperating ring stents (LS) has a pressure Unreduced diameter d 2 The stent (S) overlaps the other of the two cooperating ring stents having the same configuration.

[0050] The folded shape is a compressible ring stent that folds upon compression to form a curved section. and having at least one resilient hinge portion therebetween, preferably two spaced apart resilient hinge portions. Each of the resilient hinge portions may have a shaped "V" shape. Alternatively, the collapsed configuration may be a collapsed configuration in which a compressible ring stent is compressed. During contraction, the curved portions are folded to form sinusoidal curves, and in some embodiments, the curved portions are formed by ridges and The elastic member may be shaped like a "saddle" having at least two spaced apart elastic members. The hinge portion may be a set "V" shape, and the compressible ring stent The ring stent portion can be arranged in a V-shaped configuration. Shape setting of the hinge portion can be accomplished by heat setting.

[0051] Used to form a combination of two cooperating ring stents of different configurations Ring stents are radially compressible "Z" stents, or "zigzag" stents, Compressible ring stents, compressible shape-set ring stents, or "saddle In this case, the ring stent to be used may be selected from the ring stent having the shape of In a combination of two cooperating ring stents of different configurations, the ring stents One of the stents is a ring stent (S) with a relatively steep "saddle" shape, and the other is a comparatively From a range of sizes such as the ring stent (LS) with a "saddle" shape that is not particularly steep You can choose.

[0052] US Pat. No. 5,035,706 discloses an example of a radially compressible "Z" stent. U.S. Patent No. 9,993,329 discloses an example of a compressible "saddle" shaped ring stent. do.

[0053] US Patent Application Publication No. 20170007391 discloses a stent graft having a tubular configuration. The stent graft has multiple elastic rings that are tubular and extend between both ends of the graft. The elastic rings are arranged intermittently in the axial direction of the saddle-shaped delivery system, and each elastic ring is deformed into a "saddle shape." The stent graft is housed within a thin auxiliary elastic band that is less rigid than the elastic ring. The auxiliary elastic wire is directly connected to the multiple elastic rings disposed at the end of the auxiliary elastic wire. The auxiliary elastic wire is connected to the first and second elastic wires in series or through a graft. The auxiliary elastic wire is an endless loop formed from the first wire element and the second wire element. The lid is endless and connected by wire elements for tilt stability due to regular spacing However, the auxiliary elastic wire has a recessed portion and a protruding portion in the graft. The elastic rings at the ends do not cross over each other. Therefore, U.S. Patent Application Publication No. 201700073 The stent graft disclosed in '91 is fundamentally different from that disclosed herein.

[0054] At least two cooperating ring stents of different configurations compressible into a collapsed configuration. Another type of stent may be a radially compressible Z-stent. The other of the two cooperating ring stents of different possible configurations is the crest and It may be folded into a "saddle" shape having a valley portion. In configuration, the "saddle" shaped ring stent has a cooperating ring stent. Cooperating ring stents are attached to the tubular fabric member at selected discrete points. However, they can move freely relative to each other at their intersections. This allows the cooperating rings to The different levers required for compact folding into a delivery catheter and subsequent deployment are It becomes possible to undergo the bell's transformation.

[0055] One of two cooperating ring stents of different configurations compressible into a collapsed configuration includes: A radially compressible, shape-set ring steel having a hinge portion, such as a V-shaped portion. The device may be a folded structure having two cooperating rings of different configurations that can be compressed into a folded shape. The other end of the stent is folded into a "saddle" shape having peaks and valleys when compressed. In some embodiments, a "saddle" shaped ring sta The tubular fabric member is the outermost member and is attached to the tubular fabric member and is fitted to another cooperating configured The ring stent intersects with the ring stent. The cooperating shape-set ring stent provides radial crimping. This allows it to be compressed to a smaller diameter, and each attachment point is a saddle-shaped ring. Selectively attached to the tubular fabric member, such as in the fabric area behind the peak quarter of the tent This allows sufficient relative movement between the rings for delivery into the catheter and Accommodate the desired level of deformation required to compactly fold for subsequent deployment. It is possible.

[0056] The shape-set ring stent is associated with the peaks of the "saddle-shaped" ring stent. The tubular fabric member may be selectively attached to the tubular fabric member at points corresponding to the fabric areas to be attached. This allows for a "smooth" fit within the tubular fabric member. The complete deployment of the "saddle-shaped" ring stent was dependent on the presence of a shaped ring stent. The preferred radius of the "saddle-shaped" ring stent within the tubular fabric member is not impeded. The contoured peripheral shape is facilitated by the presence of a shape-set ring stent.

[0057] In another embodiment, two cooperating rings of different configurations are compressible into a folded shape. At least one of the stents has peaks and valleys with relatively steep "saddle" heights. The device may be compressible into a "saddle" shape that compresses into a folded shape. The other of the two cooperating ring stents has a relatively steep slope having peaks and valleys. The saddle may be compressible into a non-slip "saddle" shape.

[0058] As used herein and referred to above, the "saddle" shape refers to a constraining sleeve or sheath. The material has sufficient elasticity to be reversibly folded into a compact packaged form within the container. This refers to a typical circular ring stent made of a material that is , deform in a predictable way, resulting in the formation of folds and diametrical deformations around the circumference of the ring. The first pair of opposing points are displaced in one axial direction. Meanwhile, a point is located at the center of the circumference between the first pair. A second pair of diametrically opposed points are axially displaced opposite the first pair, forming a symmetrical "saddle" Any implementation using such a "saddle" shaped ring stent will In terms of morphology, the ring stent is folded to form two peaks and two valleys. The shape memory material, such as Nitinol (nickel-titanium alloy), You can use the "saddle" shape to "remember" it. Or you can use the "saddle" shape to By selectively attaching the stent to the fabric of the tubular fabric member, for example, the ridges and The "saddle" shape is simply held in the desired shape by stitching at least the valley portion to the fabric. It is also possible.

[0059] Such a "saddle" shaped ring stent is a sine wave (saddle) shaped stent as described above. A series of deformable elastic materials (strands or fibers such as Nitinol or PEEK) The "saddle" shape can be formed by a cylindrical or polygonal mandrel. By forming the elastic material on the ring stent, it can be shaped into a ring stent. do.

[0060] These "saddle" shaped stents are made by placing an open tube of the graft tubular fabric member at the "saddle" height. Luminal diameter D f The steepness of the slope can be expressed as a ratio to the saddle height. For saddle rings, 1:2.5 to 1:0.9 (i.e. ring saddle height is fabric) Tube diameter D f The ratio may range from 40% to 110% of the original value. For non-adjusted "saddle" shaped ring stents, 0 (i.e., substantially flat or deformed) (unshaped flat ring) to 1:2 (i.e., 0 to 50% of the diameter of the graft tubular fabric) The ratio may range from 0.1 to 1.

[0061] For ease of illustration herein, two cooperating ring stents of different configurations are shown. The "saddle" shape is intended to distinguish the different ring stents used in combination with A compressible ring stent that adopts a "saddle" shape when collapsed into a ring-shaped stent. It refers to a ring stent. It is used in combination with two cooperating ring stents of different configurations. The other shaped ring stent, e.g., a flexible hinge portion or a separate positive The components formed by shaped parts such as sinusoidal sections are simply "shaped" rings. and generally or specifically, for example, the hinge portion which is heat-set depending on the situation. Additionally, the wire is described as being straight, but not deformed. A ring stent formed into a circular stent is simply referred to as a "ring stent." Each ring stent is made up of multiple wire filament strands, ranging from 2 to over 120. Any diameter wire can be used that maintains the required elasticity. Suitable diameters of the wires are 0.05 mm to 2 mm, for example 0.5 mm to 1 You can choose from a range of mm.

[0062] A tubular fabric member is attached to at least one of the first end and the second end and has a different configuration. The "saddle" shaped ring stent forms a combination of two cooperating ring stents. In the embodiment using the "saddle" shaped ring stent, one of the "steep" "Saddle" height, i.e., diameter D of the tubular fabric member, f 40~110% range The other has a "saddle" height that is considered "not steep", That is, the diameter D of the tubular fabric member f These have a "saddle" height within the range of 0 to 50% of the The range is folded to form a combination of two cooperating ring stents, or Relative differences in the configuration of compressed ring stents and therefore their effectiveness As such, these ranges are intended as representative and non-limiting guidelines.

[0063] In another embodiment, two cooperating links of different configurations are compressible into a folded configuration. One of the stents has at least one "V" shaped flexible hinge portion. Optionally, the stent may be a shape-set ring stent. The component may have more than one "V" shaped flexible hinge portion. If not, the pre-configured ring stent must have at least one pre-configured "V" shape. Curved sections on either side of a "V" shaped section or between more than one "V" shaped flexible hinge section The two "V" shaped flexible hinge portions are shaped into a ring. When formed into a stent, they are oriented diametrically around the shaped ring stent. They can be positioned opposite each other.

[0064] In an embodiment, two cooperating rings of different configurations are compressible into a folded shape. At least one of the stents has two cooperating links of different configurations that are compressible into a collapsed configuration. The stent is at least partially disposed within the other of the stents.

[0065] In an embodiment, the shape-set ring stent is compressed into a radially folded configuration. The open cavity diameter D of the tubular fabric member is f It is radially expandable within the shape set. The ring stent is formed such that a portion of the shaped ring stent is longer than the length L of the tubular fabric member. f of located over the end of the tubular fabric member so as not to extend beyond and be covered by the fabric of the tubular fabric member That is, the portion is exposed as a bare stent. Alternatively, trauma of the exposed portion to the natural vascular wall that it contacts during pulsatile circulation may be avoided. Covered or coated with a material that reduces its resistance.

[0066] In an embodiment, the "V" shaped portion of the shaped ring is axially spaced apart from the length L of the tubular fabric member. f The curved portion is within the length L of the tubular fabric member. f Extends beyond.

[0067] In an embodiment, the shape-set ring stent is a " The stent is at least partially disposed within a ring stent that is compressible into a "saddle" shape.

[0068] In an embodiment, the tubular fabric member has a substantially circular perimeter at each of the first and second ends. The ring stent, compressible into a "saddle" shape, has a first end and a second end. The tubular fabric member is attached to the fabric at multiple points around its circumference. The stent is selectively attached to the fabric portion of the tubular fabric member and has peaks and valleys. The compressible ring stent compresses and expands (folds and unfolds) into a "saddle" shape that The stent can slide across the shaped ring stent during folding and unfolding. It is noh.

[0069] In an embodiment, two cooperating rings of different configurations are compressible into a folded shape. Each of the stents may be compressible into a "saddle" shape having peaks and valleys. One of the two cooperating ring stents has an open lumen diameter D of the tubular fabric member. f The above Uncompressed diameter d 1 The other of the two cooperating ring stents has a tubular fabric portion. Material open lumen diameter D f and has a diameter d 1 Significantly larger than uncompressed diameter d 2 The uncompressed diameter d 1 Two cooperating ring stents having One is the uncompressed diameter d 2 Two cooperating ring stents overlap each other. The two cooperating ring stages of different configurations constrain the latter without adhering to it. The combination of the ring stents is selectively attached to the fabric of the tubular fabric member by attaching each of the two cooperating ring stents to the fabric of the tubular fabric member. The attachment can hold the devices in a cooperative relationship. The relationship is that the curved area between the "peaks" and "valleys" of the steeply saddle-shaped ring stent The present invention relates to a method for providing a method for providing a stent having a stent having a ring stent, comprising: It is also possible.

[0070] In embodiments, deployed flat rings or shallower height "saddle" rings are used. The tent provides radial restraint to the steep height "saddle" ring stent. , in use for deployment within a damaged blood vessel, a stent graft prosthetic device During deployment, flat (planar) rings or non-steep "saddle" rings on top It only opens to a limited extent, determined by the tent. This gives This could mitigate the potential problem of long-term overexpansion of the device in damaged vessels. do.

[0071] Additionally, in the overlapping stent configuration proposed herein, the inner steep height A thick "saddle" ring stent is fitted with an outer flat or shallow "saddle" ring The stent is biased against the vessel wall so that it can function for its intended purpose within the vessel being treated. The ring stent is placed in a well-aligned manner within the vessel wall to provide an adequate seal for the stent to penetrate the vessel wall.

[0072] As disclosed herein, other combinations may be used to achieve similar benefits. The set "hinged" ring stent is slid onto the set ring stent section. "Saddle" shaped end links configured as movably crossed over outer ring stents. When used in combination with a ring stent, the shaped ring stent can be This allows the vessel to expand radially in the direction perpendicular to the wall of the native vessel being repaired. The directional expansion causes the "saddle" shaped end ring stent to assume the desired circular cross-sectional shape, On the other hand, the compression of the steeper "saddle" shape keeps the shape shallower compared to the steeper "saddle" shape. Therefore, the inner shaped ring is supported by the outer "saddle" shaped end ring. The so-called “saddle” shaped end rings of the stent are deployed only when the stent is in the “saddle” shape. Prevents distortion into a "petal" shape or "ovalization" deformation. Such "ovalization" is the process of Overexpansion (risk of excessive tension on the native vascular wall) and repair after long-term transplantation This may lead to potential migration of the prosthetic device from the treatment site, so Not desirable.

[0073] In all embodiments, the ring stent may be, for example, a stent that requires release at the treatment site. The stent is compressed into a compact ring stent sheath that holds it in place until it is delivered. It is further compressible into a compact configuration. It is known to use a removable sheath to restrain the device. Such uses are described, for example, in U.S. Patent Application Publication No. 2011196472 and U.S. Patent Application No. As described in Publication No. 2013178925.

[0074] The ring stent described herein is a stent graft formed from a tubular fabric material, After the delivery constraints, such as the sheath, are removed, the ring stent self-expands to create an open lumen structure. This enables the organization to be supported in its construction.

[0075] In an embodiment, at least one of the first end and the second end of the tubular fabric member are different. The stent can be supported by a combination of two cooperating ring stents in a configuration similar to that described above. Each of the two cooperating ring stents of the configuration is compressible into a collapsed configuration. The stent graft prosthesis may optionally be secured to the prosthesis by additional stents over its length. The stent graft prosthesis can be supported by the stent graft when deployed in the native blood vessel. When in the configured shape, any of the optional additional stents may be configured with two cooperating stents of different configurations. In the combination of two stents, two cooperating ring stents of different configurations are used. Do not come into contact with

[0076] In an embodiment, the stent graft prosthesis comprises two cooperating linkages of different configurations. At least one of the first end and the second end of the tubular fabric member supported by the combination of the stents. Each of the two cooperating ring stents has at least one, and optionally one each. The ring stent in the combination can be compressed into a folded "saddle" shape. The combination of two cooperating ring stents in such a configuration is steeper than the other ring stent. It is a saddle shaped slope.

[0077] In an embodiment, the different configurations at each of the first and second ends of the tubular fabric member. One of the two cooperating ring stents is a stent protrusion extending beyond the fabric of the tubular fabric member. The protruding portion may have a length L of the tubular fabric member. f Exposed beyond Alternatively, the protruding portion may be a curved portion of bare metal. Traumatic to the native vessel wall that the prosthesis comes into contact with when deployed within the lumen of the native vessel. The material may be optionally covered or coated with a material that reduces

[0078] Preferred embodiments will now be described, by way of example only, with reference to the following drawings: [Brief description of the drawings]

[0079] [Figure 1] FIG. 1 is a perspective view of a stent graft prosthesis according to a first embodiment. [Figure 2A] FIG. 2 is a side view of the stent graft prosthesis of FIG. 1. [Figure 2B] FIG. 2 is a side view of the stent graft prosthesis of FIG. 1. [Figure 3A] FIG. 13 is a diagram of a stent graft prosthesis according to a second embodiment. [Figure 3B] FIG. 13 is a diagram of a stent graft prosthesis according to a second embodiment. [Figure 3C] FIG. 13 is a diagram of a stent graft prosthesis according to a second embodiment. [Figure 4A] FIG. 11 is a diagram of a stent graft prosthesis according to a third embodiment. [Figure 4B] FIG. 11 is a diagram of a stent graft prosthesis according to a third embodiment. [Figure 4C] FIG. 11 is a diagram of a stent graft prosthesis according to a third embodiment. [Diagram 5] FIG. 11 is a perspective view of a stent graft prosthesis according to a fourth embodiment. [Figure 6A] FIG. 6 is a diagram of the stent graft prosthesis of FIG. 5. [Figure 6B] FIG. 6 is a diagram of the stent graft prosthesis of FIG. 5. [Figure 7] Figure 6 is a diagram of a stent as used in the stent graft prosthesis of Figure 5. Figure 7 shows a schematic folding of a ring stent to form a "saddle" shaped stent in either the deployed or compressed configuration. [Figure 8] FIG. 8 is a schematic side view of the end of a tubular fabric member having attached thereto a first ring stent, such as the "saddle" shaped stent of FIG. 7, and a schematic side view of a second ring stent, such as the shaped ring stent of the stent graft prosthesis of FIG. 5, which combine to form an open luminal end support for the stent graft prosthesis of FIG. [Figure 9] FIG. 10 is a diagram of a stent graft prosthesis according to a fifth embodiment. [Figure 10] FIG. 3B illustrates how the stent graft prosthesis of FIG. 3A can be deployed in a blood vessel. [Figure 11A] FIG. 6 is a diagram of a test setup to evaluate how the stent graft prosthesis of FIG. 5 can be introduced into and deployed within an arched lumen to predict performance in a procedure to repair an aortic arch or similar curved natural vessel. [Figure 11B] FIG. 6 is a diagram of a test setup to evaluate how the stent graft prosthesis of FIG. 5 can be introduced into and deployed within an arched lumen to predict performance in a procedure to repair an aortic arch or similar curved natural vessel. [Figure 12A] FIG. 1 is a perspective view of an unshaped or unfolded ring stent, the circumference of which lies in a single plane (flat ring). [Figure 12B] FIG. 1 is a schematic diagram of a "saddle" shaped ring stent. [Figure 12C] FIG. 1 is a schematic diagram of a steep "saddle" shaped ring stent. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0080] With reference to FIGS. 1, 2A and 2B, a stent graft prosthesis 1 according to a first embodiment is shown. As shown, the stent graft prosthesis 10 includes a tubular fabric member 12. The tubular fabric member 12 has a first end 14 and a second end 16. Length(L f ) is the longest dimension of the continuous tubular fabric aligned with the longitudinal axis of the tubular fabric member 12. and extends between the first and second ends 14, 16. f ) of the tubular fabric member 12 The longest dimension of the continuous tubular fabric is aligned with the longitudinal axis. Diameter D f has.

[0081] In the illustrated example, the first end 14 of the tubular fabric member 12 is formed with two cooperating ring stents 18. These stents are supported by a combination of 18a and 18b. The cooperating ring stents are a first ring stent 18a and a second ring stent 18b. The first and second ring stents 18a and 18b in the illustrated example are , 18b are "saddle" shaped stents, with peaks and valleys 20a, 20b. The first and second ring stents 18a, 18b each have a " It has a "saddle height".

[0082] As shown, first and second ring stents 18a, 18b are disposed outside the tubular fabric member 12. The first and second ring stents 18a, 18b are each formed of a tubular fabric member. Open lumen diameter D of material 12 f This is best seen in FIG. As shown, this allows the first end 14 of the tubular fabric member 12 to open upon deployment. As shown, the first ring stent 18a can be at least partially The second ring stent 18b is disposed in the second ring stent 18b. When the tubular fabric member 18a and 18b are deployed, they support the first end 14 of the tubular fabric member and are deployed within the blood vessel. When attached, it facilitates sealing with healthy portions of the native blood vessel.

[0083] As shown in this illustrative example, the first and second ring stents 18a, 18b are For example, as shown in the figure, the deployed diameter of the second ring stent 18b is The deployed diameter of the one-ring stent 18a is larger than that of the unfolded tubular fabric. When not attached to member 12, first ring stent 18a is a second ring stent. 18b, and as shown, the second ring stent 18b and the tubular fabric portion When constrained within material 12, first ring stent 18a assumes a steep "saddle" height. It is understood that the second ring stent 18b is more flexible than the first ring stent 18a. It has a much lower (less steep) "saddle" height.

[0084] In an alternative embodiment, the second ring stent 18b may be a compressed and folded "saddle" structure. The ring stent expands from a "flat" circular ring stent to a "flat" circular ring stent. This ring stent is a steeply saddle-shaped ring stent. 18a: Four points in the area between the "peak" and "valley" of the steeper "saddle" shaped ridges. It crosses over ring 18a.

[0085] Referring again to FIG. 1, the first and second ring stents 18a, 18b each may be, for example, The first and second ring stents 18a, 18b are secured to the tubular fabric member 12, for example, by sutures. The manner in which 8b is secured to tubular fabric member 12 is shown with respect to the second embodiment in FIGS. 3A and 3B. Suitable materials for the sutures include braided or monofilament. These include various forms of nylon, polypropylene, silk, and polyester. The second ring stent 18a, 18b may be balloon expandable (e.g., For example, the PALMAZ stent, made of rigid stainless steel wire, is self-expanding and It can also be made of a shape-memory material such as nickel-titanium alloy.

[0086] The stent graft prosthesis 10 is secured along its entire length by a further stent 22. However, as shown, neither of these stents 22 are supported by the first In this embodiment, the first and second ring stents 18a, 18b are not in contact with each other. The additional stent 22 is also a "saddle" shaped stent with peaks and valleys. In the illustrated example, the cooperating ring stents 18a, 18b are attached to the tubular fabric member 12. A circular end stent 24 is disposed at the first end 14 of the tubular fabric member 12. Alternatively, however, cooperating ring stents 18a, 1 8b may also be provided at the second end 16 of the tubular fabric member 12. The tubular fabric member includes a first end and a second end of the tubular fabric member. ... do.

[0087] 3A, 3B and 3C show a second embodiment of a prosthesis 100 according to the present invention. The second embodiment is a modified version of the first embodiment. In this embodiment, the tubular fabric member 11 Further stents supporting the stent 2 over its entire length include cooperating ring stents 118a, The ring stent 118a, 118b includes a plurality of combinations of tubular fabric members. Spaced along the length of the material.

[0088] 4A, 4B and 4C show a third embodiment of a prosthesis 200 according to the present invention. The third embodiment is a modified version of the first embodiment. Here, as in the first embodiment, the first and Both the first and second ring stents 218a, 218b are "saddle-shaped" stents. In this embodiment, the first ring stent 218a is disposed at the first end 2 of the tubular fabric member 212. 14, the first ring stent 218b is disposed inside the second ring stent 218b. A portion 230 of the tubular stent 218a extends beyond the length of the tubular fabric member 212. Optionally, the first ring stent 218a is formed of metal and has a cylindrical or polygonal shape. The "saddle" shape is set on the dorel. If not, the desired "saddle" is The folding operation also creates a "saddle" shape for the fabric of the tubular fabric member 212 at selected locations. The shape can be formed by sewing the shape together, as best shown in Figure 4B. Only the valley portion 220b of the first ring stent is fixed inside the tubular fabric member 212. The portion 230 of the first ring stent that extends beyond the tubular fabric member 212 is the first ring stent. This is the mountain part of tent 218a.

[0089] 5, 6A and 6B, a prosthesis 300 according to a fourth embodiment of the present invention is shown. As with the first embodiment, the stent graft prosthesis 300 includes first and second Two ends 314, 316, as well as two cooperating ring stents 318a of different configurations; 318b. Further, the tubular fabric member 312 has a combination of , similar to the first embodiment, the open lumen diameter D f However, there are two cooperating The combination of stents 318a, 318b is arranged differently relative to the first embodiment. This combination is explained below.

[0090] The cooperating ring stents include first and second ring stents 318a, 318b. The first ring stent 318a includes at least one "V" shaped portion 332. The second ring stent 318b is a shaped ring stent. The first ring stent is a "saddle" shaped ring stent with "valley" portions 350, 351. The tent 318a is disposed inside the second ring stent and has an open lumen diameter D f More than As shown, the shape-set stent 318a has two "V" shaped ends. These include hinge portions 332. These have an open lumen diameter D f At diametrically opposed positions within 3, are separated from each other by curved portions 334 and are attached to the fabric of tubular fabric member 312. Additionally, the shape-set stent 318a extends beyond the tubular fabric member 312. 3 and includes a portion 330 extending therefrom.

[0091] In the embodiment of FIGS. 5, 6A and 6B, cooperating ring stents 318a, 318 The combination of b is provided at the first end 314 of the tubular fabric member 312. A first ring stent 318a (see FIG. 1) is secured to the inner surface of the tubular fabric member 312. A second ring stent 318b (having a "saddle" shape) is secured around the first end 314 of the tubular fabric. The first and second ring stents 318a, 318b are each secured to a tubular structure by a suture. The stent is secured to the fabric member 312. As a result, the stent can be secured to the fabric member 312, for example, for delivery to the lumen of a native blood vessel. During folding to compress the graft prosthesis 300, or within the lumen of a natural blood vessel. During deployment of the stent graft prosthesis 300, if necessary, the first ring sten The second ring stent 318a can slide over the second ring stent 318b. The first ring stent 318a is attached to the "V" shaped hinge near the ridge 350. This can be achieved when the tubular fabric member 312 is secured to the inner surface of the tubular fabric member 312 by the fastener portion 332. Thus, the cooperating ring stents 318a, 318b are separately secured to the tubular fabric member 312. They can be folded compactly and then deployed simultaneously with independent relative motion. can be opened to

[0092] FIG. 7 shows the second ring stent 318b in a compressed and deployed state. As shown, in the deployed state, the "saddle" diameter of the second ring stent 318b is: In addition, the "saddle" of the second ring stent 318b is much larger than that of the compressed state. "The height is much higher in the compressed state versus the deployed state.

[0093] FIG. 8 illustrates a tubular fabric member 312 having a second ring stent 318b attached thereto, and a tubular FIG. 8 also shows the first ring stent 318a separated from the fabric member 312. The graft prosthesis 300 is shown. The first ring stent 318a is connected to the second ring stent 318b. A first ring stent 318a is secured to the inner surface of tubular fabric member 312 so as to be disposed within tubular fabric member 312b. When the stent graft prosthesis 300 is set, the stent graft prosthesis 300 is formed. The first (shaped) ring stent 318a has a “V” shape near the peak 350. The tubular fabric member 312 is secured only to the inner surface thereof by the hinge portion 332 of the tubular fabric member 312. One stent slides across the contact points with the other stent, allowing independent relative motion. It is possible to move.

[0094] FIG. 9 shows an end view of a stent graft prosthesis 400 according to a fifth embodiment of the invention. The fifth embodiment is a modification of the first embodiment. Here, like the first embodiment, The graft prosthesis 400 is a combination of ring stents having different configurations. The tubular fabric member 412 has first and second ends supported by a To this end, the first end 414 of the tubular fabric member 412 is configured as described above in the first embodiment. Two cooperating first and second ring stents 418a, 418b of different configurations functioning The tubular fabric member 412 is held open by a combination of the Ring stent 418b is a "saddle" shaped stent. In contrast to the configuration, a first ring stent 418a is disposed within a second ring stent. The first ring stent 4 has a plurality of "V" shaped hinge portions connected to each other. 18a can be referred to as a "Z" shaped stent that is compressed and radially expanded. Z-shaped stents are known per se to those skilled in the art. Similar to the embodiment, the Z-shaped stent has a "V" shaped hinge portion connected to the second ring. By fastening the tent 418b to the inner surface of the tubular fabric member 412 only in the vicinity of the peak portion of the tent 418b, This results in one stent sliding across the contact points with the other stent. This allows for independent relative motion.

[0095] FIG. 10 shows the results of a test performed in a test rig to simulate performance in a curved natural blood vessel 50. The stent graft prosthesis 100 is shown deployed in a transparent curved tube. When the prosthesis 100 is deployed from a compressed state within the blood vessel 50, the first ring Stents 118a are ring stents selectively secured to the fabric of tubular fabric member 112. Due to this, the second ring stent 118b is prevented from being obstructed by being slidable at the contact points. The second ring stent 118b is formed by tubular fabric member 112 having a circular cross section. The first ring stent 118a has a surface that acts to restrain it. This is due to the lack of stent grouping observed when using a single "saddle" shaped stent. Problems such as "ovalization" of the raft prosthesis 100 do not occur, and therefore the flow in the blood vessel 50 is To ensure long-term radial stability of the tent graft prosthesis position. The use of a steeply saddled ring stent provides stability and radial opening. (For vertical deployment) is beneficial, and non-steep (or circular) ring stents The use of may prove beneficial in achieving sealing apposition.

[0096] 11A and 11B show the results of the experiments shown in FIGS. 5, 6A and 6C, which can be seen in the transparent tube of the test device. 6B illustrates the successive steps of a method for deploying the stent graft prosthesis 300 of the embodiment of FIG. The test device is shown in Fig. 1. The proximal end of the tubular graft prosthesis is inserted into the arch section. The change in angle of the graft prosthesis was also determined, along with the extent to which the proximal end of the graft prosthesis was in contact with the surface of the tube. The test device is adapted to measure the diameter of a natural blood vessel, such as the lumen of the aortic arch. The introduction of a tubular graft prosthesis into a vessel lumen is simulated.

[0097] In patients undergoing thoracic endovascular aortic repair, structural changes and endograft size It has been observed that parallel placement to the aortic arch can sometimes be incomplete. This is called the "bird-beaking" effect.

[0098] The present disclosure relates to various implementations that are combinations of two cooperating ring stents of different configurations. The present invention addresses these problems by providing a configuration that incorporates the features of the cooperating ring stent. Gender works together to avoid or reduce these problems.

[0099] In one embodiment of the presently disclosed use, the proximal shaped ring is When the proximal end of the prosthetic graft device is withdrawn from its compact delivery configuration, The endovascular system automatically centers itself within the curved lumen of the native vessel. This action prevents the proximal sealing The stent was well aligned and stable without "bird beak" This is because the shape-set stent first exits the sheath and enters the outside of the native vessel to be repaired. Contact with the wall is easily achievable with the disclosed stent combination. The stent, once opened, reacts against the vessel wall, forming a tubular graft prosthesis. Press the proximal end of the vise to center it within the lumen of the native vessel. This is necessary for sealing. The ring stent is centrally positioned in the lumen in a stable, symmetrical "saddle" shape. This means that the proximal end of the tubular graft prosthetic device is The catheter is placed well parallel to the surrounding vessel wall without a bird's beak at the inner curve of the catheter. It is guaranteed that

[0100] In one embodiment of the tubular graft prosthetic device, the ring stent has a circumferential and attaching the tubular graft member to a circular end fabric around the tubular graft member to form a stent graft. This stent graft is a ring stent having a "peak" portion and a "valley" portion. Folds into a steep saddle shape to a diameter smaller than that of the tubular graft prosthesis Alternatively, the delivery sheath can be packaged compactly within the delivery sheath. When removed, the folded "saddle" ring forms a compact, steeply sloping "saddle" shape. Therefore, the tubular graft prosthetic device is supported by the contacting wall of the native blood vessel into which it is delivered. Depending on the constraints imposed by the catheter, the catheter may be shaped into a ring stent with a less steep "saddle" shape, or The stent opens into a circular ring stent. Many of these are "normal" procedures, but the "saddle" stent The effect of introducing a shape-set ring stent in combination with a conventional stent is remarkable. In the disclosed embodiment, the shape-set ring stent has a curved portion. The hinge has two "V" shaped hinge portions connected by a The graft portion is disposed diametrically on the fabric wall of a tubular graft member having a generally cylindrical shape. The shape-set stent has a diameter that is smaller than the diameter of the stent when compressed into a compact delivery configuration. The deformation of the direction changes it from one diameter to another smaller diameter. The stent is divided into two quarter rings by two opposing "V" shaped hinges. The graft fabric is attached to the posterior region of the ring and the 2 rings are attached to the valley quarter region of the ring. The graft is not attached to the fabric. The branch of the "V" hinge is sewn to the fabric. When attached to the stent, the shape-set stent must be ring-shaped at (at least) four points. Each point is located on the curved portion between the peaks and valleys of the "saddle" shaped ring stent. The "saddle" shaped ring stent allows for the shaped stents where these intersections occur. This positioning allows the stent attached to the stent graft to slide freely over the tent. Although the deformation modes of the stent are different, the stent graft can be compressed or expanded. This can be done.

[0101] In one embodiment, the shaped ring stent has a maximum width dimension ( Two "hinge" elements (each of which is 1.0 mm in diameter) are positioned on the ring stent. has one peak and two valleys) and between their opposing positions in the proximal direction The "hinge" portion is a ring ridge. Used to attach to the fabric at the back area of ​​the quarter. Each hinge peak is behind the ring valley. The curved portion extends beyond the edge of the graft fabric above the ring valley. The stent is then exposed to the outside air, forming "bare metal" stent elements in these areas. A bare metal stent, i.e. a stent not covered by a graft fabric, Allows atraumatic contact with the wall of the native vessel being repaired. Reduces trauma from contact. The exposed stent elements are optionally covered or coated with a material to enhance The adhesive may be glued, sewn, or otherwise treated.

[0102] In some embodiments, two cooperating ring stents of different configurations each advantageously Also, from the same memory material, for example Nitinol (NiTi alloy) wire. It can be manufactured.

[0103] The disclosed embodiments of the stent graft prosthesis according to the invention provide the following advantages: is provided. 1. The presently disclosed stent graft prosthesis is capable of delivering blood to the target treatment site within the lumen of a blood vessel. When deployed, the cooperating ring stents are deployed without the aid of a positioning mechanism in the delivery system. This provides stable positioning within the blood vessel even when 2.By combining two ring stents instead of only one ring, The second ring stent determines how far the first ring stent can open (radially) during deployment. This limits the chronic outward forces of self-expanding stents. Over time, the stent graft prosthesis acts as a second link as the underlying blood vessel remodels. The stent only opens as far as it will allow, thereby avoiding the long-term problem of overstretching of the blood vessel. It means to be avoided. 3. In addition, the stent placement of the present invention is such that the first ring stent is connected to the second ring stent. The stent is placed parallel to the vessel wall because a radial force is applied to hold it against the vessel wall. (The stent adheres better to the blood vessel wall). 4. The cooperating ring stent may be used when the delivery system is placed off-center. and / or provide a good radial fit within the vessel, even when the vessel is curved. 5. The cooperating stent, when deployed, opens radially and creates a cylindrical, stable stent perpendicular to the vessel wall. The shape becomes 6. "Bird's beak" does not occur during deployment of the stent graft prosthesis of the present invention . 7. The use of the stent graft prosthesis of the present invention allows The lack of a sharp tip at the proximal (leading during delivery) end prevents the catheter from penetrating into the vessel wall of the vessel in which it is placed. It has a non-traumatic effect. 8. The above atraumatic effect is achieved by the shaped hinge parts and the curved parts between the hinge parts. The curved portion can be achieved with a shaped ring stent having a tubular fabric member. and protruding beyond the fabric of the hinge portion to provide a proximal apex having a larger radius than the distal apex of the hinge portion. The hinge portion is fixed only at selected portions within the tubular fabric member (FIGS. 5 and 8). Alternatively, in embodiments using a saddle ring stent, the steep saddle shaped rings The stent is attached to the end of the tubular fabric member in a non-steep saddle ring stent or in a flat It can be placed in or on top of a ring stent, resulting in a steep saddle shape. The curved "peaks" of the ring stent protrude beyond the ends of the tubular fabric member (FIGS. 4a, 4b). b, and 4c). 9. Stability of the end ring stent crosses over the end ring stent to be stabilized , or this can be achieved with only one other ring stent placed across it. 10. Achievable radial deflection to maintain luminal patency of the stent graft prosthesis Stability is achieved by two cooperating ring stents of different configurations, either on the inside or outside. By crossing over one another two cooperating ring stents of different configurations on either side. It is possible to achieve this.

[0104] The following paragraphs describe embodiments and alternative configurations of the disclosed stent graft prosthesis. or a preferred embodiment. (a) Stent graft prosthesis: At least a first end and a second end, and a length L extending between the first end and the second end f and , open lumen diameter D f and a tubular fabric member having a At least one of the first end and the second end of the tubular fabric member is provided with two cooperating tubular members of different configurations. The stent is supported by a combination of rings and stents. Each of the stents is preferably stent-grafted to provide a compact delivery configuration for the stent-graft prosthesis. The tubular fabric member is compressible into a folded configuration for compressing the tubular fabric member into two cooperating configurations. Each of the ring stents is attached at a selected point along its entire length. If the stent graft prosthesis is supported by an additional stent over the entire When in the deployed configuration, any additional stent may have two cooperating links of different configurations. In the ring stent combination, two cooperating ring stents of different configurations are used. Do not come into contact with any of them. (b) Stent graft prosthesis: At least a first end and a second end, and a length L extending between the first end and the second end f and , open lumen diameter D f and a tubular fabric member having a At least one of the first end and the second end of the tubular fabric member is provided with two cooperating tubular members of different configurations. The stent is supported by a combination of rings and stents. Each of the stents is preferably stent-grafted to provide a compact delivery configuration for the stent-graft prosthesis. The tubular fabric member is compressible into a folded configuration for compressing the tubular fabric member into two cooperating configurations. Each ring is attached at a selected point to the stent. The ring stent is a ring stent having two cooperating ring stents of different configurations, one of which is a ring stent having a different configuration. The two cooperating rings of the stent are free to move relative to each other at the points where they cross over one another. One of the two cooperating ring stents of different configurations can be The other of the ring stents acting on the stent is restrained from overexpansion. (c) A stent graft prosthesis as described in paragraph (a) or paragraph (b), comprising: At least one of two cooperating ring stents of different configurations compressible into a collapsed configuration. The first is the open lumen diameter D of the tubular fabric member. f or the open lumen diameter D of the tubular fabric member f has a diameter greater than (d) A stent graft prosthesis as described in paragraph (c), in a collapsed configuration. One of two cooperating ring stents of different compressible configurations is compressed into a collapsed configuration. and a diameter that exceeds the diameter of the other of two cooperating ring stents of different configurations that can be collapsed. . (e) A stent graft according to any one of paragraphs (a), (b), (c) or (d). A hamstring prosthesis having two cooperating limbs of different configurations compressible into a folded configuration. One of the stents is a shape-set stent having at least one "V" shaped hinge portion. It is a ring stent. (f) A stent graft according to any one of paragraphs (a), (b), (c), or (d). A hamstring prosthesis having two cooperating limbs of different configurations compressible into a folded configuration. One of the stents has more than one "V" shaped hinge section and a curved section between them. minutes, and (g) A stent graft according to any one of paragraphs (a), (b), (c) or (d). A hamstring prosthesis having two cooperating limbs of different configurations compressible into a folded configuration. One of the stents has multiple connected "V" shaped hinge sections, optionally with Z-sprung A shape set ring stent having a tent configuration. (h) A stent-graft prosthesis according to any one of paragraphs (e), (f), or (g). The present invention relates to a stent having a shape-set ring stent, the shape-set ring stent being compressible into a radially folded shape. and the open lumen diameter D of the tubular fabric member fIt is radially expandable within the The ring stent is a tubular fabric member having a length L of a portion of the shaped ring stent. f Exceeding and disposed over the end of the tubular fabric member so as not to extend beyond the end of the tubular fabric member and be covered by the fabric of the tubular fabric member. do. (i) The stent graft prosthesis of paragraph (h), comprising a shaped ring. The "V" shaped hinge of the tubular fabric member has a length L f It's inside. (j) A stent graph as described in any one of paragraphs (e), (f), (g) or (h). A shape-set prosthesis having at least one "V" shaped hinge portion. The ring stent is at least partially comprised of two cooperating ring stents of different configurations. The other of the two cooperating ring stents of different configurations is disposed within the other of the ring stents. The ring stent can be compressed into a "saddle" shape having a groove and a valley. , by a "V" shaped hinge portion, or by each "V" of a shaped ring stent. The hinged portion of the ring stent is attached to the fabric of the tubular fabric member at the peak of the ring stent in the shape of a "saddle". It is installed (Figure 5). (k) The stent graft prosthesis of paragraph (j), wherein the tubular fabric member has a first end. Each of the first and second ends has a substantially circular perimeter. A ring stent has a plurality of rings around a substantially circular circumference at a first end and a second end. The stent is attached to the fabric of the tubular fabric member at a point. , selectively attached to the fabric portion of the tubular fabric member at the same end, The ring stent is compressible into a "saddle" shape having a portion that can be shaped as needed. This allows the ring to slide over the stent. (l) paragraphs (a), (b), (c), (d), (e), (f), (g), (h), (i); (i) a stent graft prosthesis according to any one of (a), (b), (c), (d), or (e), Different configurations of the two cooperating ring stents are One of the ring stents is relatively sharp compared to the other of the two cooperating ring stents of different configurations. This involves forming a gradient "saddle" shaped ring stent. (m) A stent graft according to any one of paragraphs (a), (b), (c) or (d). A hamstring prosthesis having two cooperating limbs of different configurations compressible into a folded configuration. Each of the stents is compressible into a "saddle" shape having peaks and valleys. One of the two cooperating ring stents has an open lumen diameter D of the tubular fabric member. f More than compressed Not the diameter d 1 The other of the two cooperating ring stents is an opening of the tubular fabric member. Lumen diameter D f and has a diameter d 1 The uncompressed diameter d is significantly larger than 2 The uncompressed diameter d 1 One of the two cooperating ring stents has Uncompressed diameter d 2 The two cooperating ring stents overlap one another, The latter is restrained without adhering to the (n) The stent graft prosthesis of paragraph (m), comprising an uncompressed straight Diameter d 1 One of the two cooperating ring stents is compressed at four intersections. No diameter d 2 Each of the two cooperating ring stents has a pressure Unreduced diameter d 2 The ring stent has peaks and valleys in the area between the peaks and valleys. (o) The stent graft prosthesis of paragraph (m), comprising an uncompressed straight Diameter d 2 One of the two cooperating ring stents is in a "saddle" shaped configuration. The "valley" portion is attached within the tubular fabric member, and the "peak" portion is the length L of the tubular fabric member. f of attached to the fabric of the tubular fabric member so as not to protrude beyond and be covered by the fabric of the tubular fabric member It is being done. (p) A stent graft prosthesis according to any one of the preceding paragraphs, comprising a tubular fabric One of the two cooperating ring stents at each of the first and second ends of the member is Length of tubular fabric member L f The exposed curved portion is greater than or equal to the base. Astent or covered with material to reduce traumatic contact with native vessels , or coated.

[0105] The illustrated embodiment is a combination of stents developed by the inventors. These are provided as non-limiting examples of possible stent graft prosthetic devices. Further modifications and improvements are within the scope of the invention as disclosed herein and claimed below. It can be incorporated without deviation.

Claims

1. 1. A stent graft prosthesis comprising: At least a first end and a second end, and a length L extending between the first end and the second end ｆ and the open lumen diameter D ｆ and a tubular fabric member having At least one of the first end and the second end of the tubular fabric member is supported by a combination of two cooperating ring stents of different configurations, each of the two cooperating ring stents of different configurations being compressible into a folded configuration to provide a compact delivery configuration of the stent graft prosthesis, and the tubular fabric member is attached at a selected point to each of the two cooperating ring stents of different configurations; A stent graft prosthesis, wherein two cooperating ring stents of different configurations have different uncompressed diameters and are positioned so that one is disposed inside the other, wherein one of the two cooperating ring stents of different configurations can move freely relative to each other at the point where it intersects with the other of the two cooperating ring stents of different configurations, and wherein one of the two cooperating ring stents of different configurations is restrained from overexpansion by the other of the two cooperating ring stents of different configurations.

2. 2. A stent graft prosthesis as claimed in claim 1, wherein each of the two cooperating ring stents of different configurations is compressible into a folded "saddle" shape having two peaks and two valleys.

3. 3. A stent graft prosthesis as claimed in claim 1 or 2, wherein one of the two cooperating ring stents of different configurations compressible into a folded shape is a shaped ring stent having at least one "V" shaped hinge portion.

4. 4. The stent graft prosthesis of claim 3, wherein one of the two cooperating ring stents has two "V" shaped hinge portions attached to the fabric of the tubular fabric member, separated from each other by a curved portion so as to be in diametrically opposed positions within the open lumen diameter Df.

5. 2. A stent graft prosthesis as described in claim 1, wherein the other of the two cooperating ring stents of different configuration is compressible into a folded "saddle" shape having two peaks and two valleys, the peaks being axially aligned with the peaks of at least one of the two cooperating ring stents of different configuration.

6. A stent graft prosthesis as described in claim 3 or 4, wherein the "V" shaped hinge portion of one of the two cooperating ring stents of different configuration is located near the crest of the other of the two cooperating ring stents of different configuration.

7. A stent graft prosthesis according to any one of claims 1 to 6, wherein one of the two cooperating ring stents having an uncompressed diameter d 1 corresponds to a "less steep saddle" shaped ring stent (LS) and the other of the two cooperating ring stents having an uncompressed diameter d 2 corresponds to a "steep saddle" shaped ring stent (S).

8. A stent graft prosthesis as described in any one of claims 1 to 7, wherein the other of two cooperating ring stents of different configuration crosses over at least one of the two cooperating ring stents of different configuration at four points, each point being in the area between the peaks and valleys of the folded ``saddle'' shape.

9. A stent graft prosthesis according to any one of claims 1 to 8, wherein one of the two cooperating ring stents of different configurations compressible into a folded shape is arranged inside the other of the two cooperating ring stents of different configurations compressible into a folded shape, and the open lumen diameter D ｆ 4. A stent graft prosthesis having a diameter greater than 1 mm.

10. 10. A stent graft prosthesis as claimed in any one of claims 1 to 9, wherein one of the two cooperating ring stents of different configuration has an exposed portion extending beyond the tubular fabric member.

11. 11. A stent graft prosthesis as claimed in any one of claims 1 to 10, wherein one of the two cooperating ring stents of different configuration is fixed to an inner surface of the tubular fabric member and the other of the two cooperating ring stents of different configuration is fixed around a first end of the tubular fabric member.

12. 12. A stent graft prosthesis as claimed in any one of claims 1 to 11, wherein each of the two cooperating ring stents of different configurations is secured to the tubular fabric member by sutures such that one of the two cooperating ring stents of different configurations is slidable relative to the other of the two cooperating ring stents of different configurations.

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