Method and device for attaching a stent structure to aaa graft material

METHOD AND DEVICE FOR ATTACHING A STENT STRUCTURE TO AAA GRAFT MATERIAL

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to aneurismal repair devices, and more particularly, to devices and methods for attaching graft material to intraluminal scaffolds or stents to eliminate the relative movement between the graft material and the stent.

2. Discussion of the Related Art

An aneurysm is an abnormal dilation of a layer or layers of an arterial wall, usually caused by a systemic collagen synthetic or structural defed. An abdominal aortic aneurysm is an aneurysm in the abdominal portion of the aorta, usually located in or near one or both of the two iliac arteries or near the renal arteries. The aneurysm often arises in the intrarenal portion of the diseased aorta, for example, below the kidneys. A thoracic aortic aneurysm is an aneurysm in the thoracic portion of the aorta. When left untreated, the aneurysm may rupture, usually causing rapid fatal hemorrhaging.

Aneurysms may be classified or typed by their position as well as by the number of aneurysms in a duster. Typicaly, abdominal aortic aneurysms may be classified into five types. A Type I aneurysm Is a single dilation located between the renal arteries and the iliac arteries. Typically, in a Type I aneurysm, the aorta is healthy between the renal arteries and the aneurysm and between the aneurysm and the iliac arteries.

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A Type II A aneurysm is a single dilation located between the renal arteries and the iliac arteries. In a Type II A aneurysm, the aorta is healthy between the renal arteries and the aneurysm, but not healthy between the aneurysm and the iliac arteries. In other words, the dilation extends to the aortic bifurcation. A Type II B aneurysm comprises three dilations. One dilation Is located between the renal arteries and the iliac arteries. Like a Type II A aneurysm, the aorta Is healthy between the aneurysm and the renal arteries, but not healthy between the aneurysm and the Mac arteries. The other two dilations are located in the iliac arteries between the aortic bifurcation and the bifurcations between the external iliacs and the internal iliacs. The iliac arteries are healthy between the iliac bifurcation and the aneurysms. A Type II C aneurysm also comprises three dilations. However. In a Type II C aneurysm, the dilations In the iliac arteries extend to the iliac bifurcation.

A Type III aneurysm is a single dilation located between the renal arteries and the iBac arteries. In a Type III aneurysm, the aorta is not healthy between the renal arteries and the aneurysm. In other words, the dilation extends to the renal arteries.

A ruptured abdominal aortic aneurysm is presently the thirteenth leading cause of death in the United States. The routine management of abdominal aortic aneurysms has been surgical bypass, with the placement of a graft In the involved or dilated segment. Although resection with a synthetic graft via a transperitoneal or retroperitoneal procedure has been the standard treatment, it is associated with significant risk. For example, complications Include perioperative myocardial ischemia, renal failure, erectile impotence, intestinal Ischemia, infection, lower limb ischemia, spinal cord Injury with paralysis, aortaenteric fistula, and death. Surgical treatment of abdominal aortic aneurysms is associated with an overall mortality rate of five percent in asymptomatic patients, sixteen to nineteen percent in symptomatic patients, and Is as high as fifty percent in patients with ruptured abdominal aortic aneurysms.

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Disadvantages associated with conventional surgery, in addition to the high mortality rate, include an extended recovery period associated with the large surgical incision and the opening of the abdominal cavity, difficulties in suturing the graft to the aorta, the loss of the existing thrombosis to support and reinforce the graft, the unsuitability of the surgery for many patients having abdominal aortic aneurysms, and the problems associated with performing the surgery on an emergency basis after the aneurysm has ruptured. Further, the typical recovery period Is from one to two weeks in the hospital and a convalescence period, at home, ranging from two to three months or more, If complications ensue. Since many patients having abdominal aortic aneurysms have other chronic illnesses, such as heart, lung, liver and/or kidney disease, coupled with the fact that many of these patients are older, they are less than ideal candidates for surgery.

The occurrence of aneurysms is not confined to the abdominal region. While abdominal aortic aneurysms are generally the most common, aneurysms in other regions of the aorta or one of its branches are possible. For example, aneurysms may occur in the thoracic aorta. As is the case with abdominal aortic aneurysms, the widely accepted approach to treating an aneurysm in the thoracic aorta is surgical repair, involving replacing the aneurysmal segment with a prosthetic device. This surgery, as described above, is a major undertaking, with associated high risks and with significant mortality and morbidity.

Over the past five years, there has been a great deal of research directed at developing less invasive, endovascular, i.e., catheter directed, techniques for the treatment of aneurysms, specifically abdominal aortic aneurysms. This has been facilitated by the development of vascular stents, which can and have been used in conjunction with standard or thin-waH graft material in order to create a stent-graft or endograft. The potential advantages of less invasive treatments have included reduced surgical morbidity and mortality along with shorter hospital and intensive care unit stays.

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Stent-grafts or endoprostheses are now Food and Drug Administration (FDA) approved and commercialy available. Their delivery procedure typically involves advanced angiographic techniques performed through vascular accesses gained via surgical cut down of a remote artery, which may include the common femoral or brachial arteries. Over a guidewire, the appropriate size introducer will be placed. The catheter and guidewire are passed through the aneurysm. Through the introducer, the stent-graft will be advanced to the appropriate position. Typical deployment of the stent-graft device requires withdrawal of an outer sheath while maintaining the position of the stent-graft with an inner-stabilizing device. Most stent-grafts are self-expanding; however, an additional angioplasty procedure, e.g., balloon angioplasty, may be required to secure the position of the stent-graft. Following the placement of the stentgraft, standard angiographic views may be obtained.

Due to the large diameter of the above-described devices, typically greater than twenty French (3F=1 mm), arteriotomy closure typically requires open surgical repair. Some procedures may require additional surgical techniques, such as hypogastric artery embolization, vessel ligation, or surgical bypass in order to adequately treat the aneurysm or to maintain blood flow to both lower extremities. Likewise, some procedures will require additional advanced, catheter directed techniques, such as angioplasty, stent placement and embolization, in order to successfully exclude the aneurysm and efficiently manage leaks.

While the above-described endoprostheses represent a significant improvement over conventional surgical techniques, there is a need to improve the endoprostheses, their method of use and their applicabity to varied biological conditions. Accordingly, in order to provide a safe and effective alternate means for treating aneurysms, including abdominal aortic aneurysms and thoracic aortic aneurysms, a number of difficulties associated with currently known endoprostheses and their delivery systems must be overcome. One concern with the use of endoprostheses is the prevention of endo-leaks and the disruption of the normal fluid dynamics of the vasculature. Devices using any

CA 02944014 2016-09-30 technology should preferably be simple to position and reposition as necessary, should preferably provide an acute, fluid tight seal, and should preferably be anchored to prevent migration without Interfering with normal blood flow in both the aneurysmal vessel as well as branching vessels. In addition, devices using 5 the technology should preferably be able to be anchored, sealed, and maintained in bifurcated vessels, tortuous vessels, highly angulated vessels, partially diseased vessels, calcified vessels, odd shaped vessels, short vessels, and long vessels. In order to accomplish this, the endoprostheses should preferably be highly durable, extendable and re-configurable while maintaining 10 acute and long-term fluid tight seals and anchoring positions.

The endoprostheses should also preferably be able to be delivered percutaneousiy utilizing catheters, guidewires and other devices which substantially eliminate the need for open surgical intervention. Accordingly, the 15 diameter of the endoprostheses in the catheter is an important factor. This is especially true for aneurysms in the larger vessels, such as the thoracic aorta. In addition, the endoprostheses should preferably be percutaneousiy delivered and deployed such that surgical cut down is unnecessary.

Many aneurismal repair devices currently in the market utilize a woven

Dacron® graft material and a metallic stent or scaffold. Typically, the stents are attached to the graft material by sutures. Even though the stents are sutured in place, this does not completely eliminate relative movement between the stent and the graft material caused by the pulsatile movement of the blood In the 25 particular artery and the movement of the artery itself. This relative motion between the stent and the graft causes wear and potentially a separation or opening between the graft and the stent. This potential separation or opening may in turn lead to endo leaks. Accordingly, it would be highly advantageous to develop a system for preventing this or substantially eliminating relative movement between the stent and the graft

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SUMMARY OF THE INVENTION

The present invention overcomes the disadvantages associated with currently utilized aneurismal repair devices that exhibit relative motion between the components of the system as briefly described above.

In accordance with one aspect, the present invention is directed to an aneurismal repair system. The aneurismal repair system comprises at least one substantially cylindrical stent segment and graft material affixed, via attachment elements, to the at least one substantially cylindrical stent segment The at least one substantially cyfindrical stent segment comprising a substantially zigzag shaped configuration with attachment sections proximate at least one apex.

in accordance with another aspect the present invention is directed to an aneurismal repair system. The aneurismal repair system comprises at least one substantially cylindrical stent segment and graft material affixed to the at least one substantially cylindrical stent segment The graft material comprises a plurality of openings and the substantially cylindrical stent segment comprises a substantially zigzag shaped configuration with attachment sections proximate at least one apex that are configured to be positioned and secured with the plurality of openings in the graft material.

A majority of aneurismal repair devices such as abdominal aortic aneurysm repair devices currently on the market utilize a woven synthetic fiber graft material and a metallic stent. Typically, the stents are attached to the graft material by sutures. Even with the stents sutured in place, this does not completely eliminate stent movement caused by the pulsatile movement of the vessel, e.g. the aorta. This relative motion between the stent and the graft Is what causes fiber wear and potential fiber separation. In other words, the pulsatile motion of the vessel causes the stent to rub against the graft material potentially resulting in holes that cause endoleaks. Accordingly, the present invention is directed to a unique stent apex configuration and its attachment method to prevent or substantially eliminate any relative motion between the β

CA 02944014 2016-09-30 stent and the graft. In addition to the stent shape, a unique attachment method, the so called the delta stitch is added to ensure better security at the attachment site.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will be apparent from the following, more particular description of preferred embodiments of the invention, as fflustrated in the accompanying drawings.

Figure 1 is a diagrammatic representation of the exemplary anchoring and sealing prosthesis in accordance with the present invention.

Figure 2 is a diagrammatic representation of an exemplary anchoring and 15 sealing prosthesis with no graft material and/or stitching in certain locations In accordance with the present invention.

Figure 3 is an elevational view of an endovascular graft in accordance with the present invention.

Figure 4 is a perspective view of an expanded stent segment of the endovascular graft In accordance with the present invention.

Figure 4A is a fragmentary perspective view of a portion of the stent 25 segment of Figure 4.

Figure 4B is a fragmentary perspective view of a portion of the stent segment of Figure 4.

Figure 4C is an enlarged plan view of a section of the stent segment of

Figure 4.

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Figure 4D is an enlarged plan view of a section of the stent segment of

Figure 4.

Figure 5 is a perspective view of another expanded stent segment of the endovascular graft in accordance with the present invention.

Figure 6 is an elevational view of an endovascular graft in accordance with the present invention.

Figure 7 is a diagrammatic representation of a stent segment having a first modified apex design in accordance with the present invention.

Figures 8A and 8B are diagrammatic representations of a portion of the modified apex as it is attached to the graft material in accordance with the present invention.

Figure 9A is a diagrammatic presentation of a modified graft in accordance with the present invention.

Figure 9B is a diagrammatic representation of a modified stent-graft in accordance with the present invention.

Figure 10 is a diagrammatic representation of a stent segment having a second modified apex design in accordance with the present invention.

Figure 11 is a diagrammatic representation of a stent segment having a third modified apex design In accordance with the present invention.

Figure 12 is a diagrammatic representation of a stent segment having a fourth modified apex design in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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Referring to Figure 1. there is illustrated an exemplary embodiment of an anchoring and sealing component 100 of an aneurysm repair system. The 5 anchoring and sealing component 100 comprises a trunk section 102 and a bifurcated section, including two legs 104,106. Graft material 106, described in detail below, is affixed to at least a portion of the trunk section 102 and to all of the legs 104,106. The graft material may be attached via any number of means. In the exemplary embodiment, the graft material 108 is attached to various 10 portions of the underlying structure by sutures 110. As illustrated, the graft material 108 is affixed with a continuous stitch pattern on the end of the trunk section 102 and by single stitches elsewhere. It Is Important to note that any stitch pattern may be utilized, and other devices, such as staples, may be utlfized to connect the graft material 108 to the underlying structure. The sutures 110 15 may comprise any suitable biocompatible material that is preferably highly durable and wear resistant.

The underlying structure of the trunk section 102, as fflustrated in Figure 2, comprises a substantially tubular stent structure or lattice comprising multiple 20 stent sections. The stent or lattice structure comprises a single row of substantially diamond shaped elements 112 on one end, multiple nows of substantially diamond shaped elements 114 on the other end, a plurality of longitudinal struts 116 and a single, substantially zigzag shaped stent element 117. The pkiraity of longitudinal struts 116 are connected to the apexes of the 25 substantially diamond shaped elements 114. The single, substantially zigzag shaped stent element 117 comprises a number of barbs 119 protruding therefrom for anchoring the device In the vessel to be repaired. This exemplary embodiment may be utilized for anchoring and sealing in positions wherein there are branches off the main artery. For example, this exemplary embodiment may 30 be utilized for supra-renal anchoring. Accordingly, the graft material 108 Is only attached below the longitudinal struts 116 so that blood may flow Into the renal arteries from the aorta. Infra-renal designs are also possible.

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The underlying structure of the bifurcated section, as Illustrated in Figure 2, comprises a plurafity of individual, substantially tubular stent elements 118. Each stent element 118 comprises a substantially zigzag pattern. As illustrated, leg 104 comprises three stent elements 118a, 118b, 118c and leg 106 comprises 5 two stent elements 118d, 118e. As illustrated, In this exemplary embodiment, the stent elements do not line up and the legs are of two different lengths. This exemplary design allows for nesting of the legs 104,106 such that the profile of the device is reduced.

In order to compensate for the missing stent elements, the legs are connected at the bifurcation as illustrated in Figure 1. The legs 104,106 may be connected in any suitable manner. In the exemplary embodiment, the two legs 104,106 are connected by suturing them together. The sutures 120 connect the graft material 108 on each leg 104, 106 together. The sutures may be non15 biodegradable or biodegradable. Biodegradable sutures would dissolve over time thereby allowing the two legs to move independently.

Referring now to Figure 3, there is illustrated an exemplary embodiment of an endovascular graft 300 of an aneurysm repair system. The exemplary 20 endovascular graft 300 comprises one or more first stent segments 310, one second stent segment 320 and a third stent segment 330. In a typical use scenario, the third stent segment 330 would be anchored in healthy tissue below the aneurysm and the uppermost first stent segment 310 would be in fluid communication with the anchoring and sealing component 100. The second 25 stent segment 320 comprises a tapered profile, having a diameter at one end equal to that of the first stent segment 310 and a diameter at the other end equal to that of the third stent segment 330. The length of the endovascular graft 300 may be adjusted by varying the number of first stent segments 310 utilized.

Figure 4 is a detailed perspective view of an exemplary embodiment of the third stent segment 330. The third stent segment 330 comprises a plurality of struts 332 connected in a substantially zigzag pattern. As illustrated, the exemplary third stent segment 330 comprises three sets of zigzag-connected io

CA 02944014 2016-09-30 struts 332, thereby forming substantially diamond-shaped cells. The nonconnected apex 334 of each diamond shaped cell, illustrated in greater detail in Figure 4A, comprises a smooth, uniform width curved region formed at the intersection of two struts 332 of each diamond-shaped cell. This shape Is cut 5 directly into the stent segment 330 during the initial machining steps, typically laser cutting, and is maintained during all subsequent finishing processing. The junctions 336 between the zigzag- connected struts 332, illustrated in greater detail in Figure 4B occurs at the intersection of four struts 332. Preferably, each junction 336 of four struts 332 comprises two indentations 338 and 340 as 10 illustrated in Figure 4B.

The regions proximate the non-connected apexes 334 and the junctions 336 are generally the highest stress regions in the third stent segment 330. To minimize the stressesjn.these regions, these regions are designed to maintain 15 uniform beam widths proximate where the struts 332 Interconnect. Beam width refers to the width of a strut junction 336. Indentations 338 and 340 are cut or machined into the junctions 336 to maintain a uniform beam width in this area, which is generally subject to the highest stress. Essentially, by designing the junctions 336 to maintain uniform beam widths, the stress and strain that would normally build up in a concentrated area, proximate the junction 336, is allowed to spread out into the connecting regions, thereby lowering the peak values of the stress and strain In the stent structure.

To further minimize the maximum stresses in the struts 332 of the third stent segment 330, the struts 332 may have a tapering width. For example, in one exemplary embodiment, the struts 332 may be designed to become wider as it approaches a junction 336. Figure 4C is an enlarged partial view of the third sent segment 330 in its expanded conditions which fllustrates the tapering width of the struts 332. In this exemplary embodiment, the strut 332 proximate the junction 336 (width a) is about 0.025 cm and gradually tapers to a dimension of about 0.0178 cm in the mid-region of the strut 332 (width b). By tapering the struts' widths, the stresses in the struts 332 adjacent the junction 336 is spread out away from the junction 336. The tapering of the struts 332 Is accomplished

CA 02944014 2016-09-30 during the machining of the tube of material from which the stent 330 is cut. However, by tapering the struts 332 in this manner, there is a tradeoff. The stent segment 330 becomes somewhat less resistant to localized deformations, caused for example, by a protrusion within the vessel lumen. This localized 5 deformation may lead to a local torsional loading on some of the struts 332, and, therefore, since the struts 332 in this exemplary embodiment have a relatively significant portion of their length with a reduced width, their torsional rigidity is reduced.

If maximizing the resistance to localized deformation is preferred, the struts 332 may be maintained at a uniform width, or more preferably have a reverse taper, as iBustrated in Figure 4D, wherein the width at point a is less than the width at point b. In this exemplary embodiment, the reverse taper struts 332 _______are about 0.025 cm proximate the junction 336 and about 0.028 cm in the central region of the struts. While this reverse taper tends to increase the stresses somewhat proximate the junctions 336, this increase is very small relative to the decrease In stresses gained by having the side indentations 338, 340 illustrated in Figure 4B, as well as the uniform width connections illustrated in Figure 4A. In addition, since the reverse taper serves to increase the torsional rigidity of the start 332, the stent structure resists local deformation and tends to maintain a substantially circular cross-sectional geometry, even if the lumen into which the stent is positioned in non-circular in cross-section.

In a preferred exemplary embodiment, the third stent segment 330 is fabricated from a laser cut tube, of Initial dimensions 0.229 cm inside diameter by 0.318 cm outside diameter. The struts 332 are preferably 0.0229 cm wide adjacent the four strut junctions 336 and six mm long, with a reverse taper strut width. Also, to minimize the number of different diameter combination of grafts systems, it is preferred that the third stent segment 330 have an expanded diameter of sixteen mm. Similarly, the proximal portion of the graft material forming the legs is flared, having a diameter of sixteen mm. This single diameter for the third stent segment of the graft system would enable its use in arteries having a non-aneurysmal region of a diameter from between eight and fourteen

CA 02944014 2016-09-30 mm in diameter, it is also contemplated that multiple diameter combinations of third stent segment 330 and graft flare would be desirable.

Referring back to Figure 3, the one or more first stent segments 310 are also formed from a shape set laser cut tube, simflar to the third stent segment

330 described above. The one or more first stent segments 310 comprise a single circumferential row of zigzag or sinusoidally arranged elements. In the exemplary embodiment illustrated in Figure 3, and in greater detail in Figure 5, the first stent segment 310 comprises ten zigzag or sinusoidal undulations. The 10 one or more first stent segments 310 are formed with uniform width connections at the intersections 314 of the struts 312 forming the zigzag or sinusoidal pattern.

The one or more first stent segments 310 are preferably cut from tubing having an inside diameter of 0.251 cm and an outside diameter of 0.317 cm. The strut widths are preferably about 0.33 cm wide adjacent strut intersections 314 and 15 the struts 312 are preferably seven mm long and the one or more first stent segments 310 are preferably eleven mm in diameter when expanded.

The second stent segment 320 comprises a tapered profile, having a diameter at one end which is the same as the one or more first stent segments 20 310, and a diameter at the other end matching the diameter of the third stent segment 330. The second stent segment 320 Is identical to the one or more first stent segments 310 except for the taper.

As is explained in detail subsequently, the stent segments 310, 320 and 25 330 are secured in position by the graft material.

Nitinol is utilized in a wide variety of applications, including medical device applications as described herein. Nitinol or Ni-Ti alloys are widely utilized in the fabrication or construction of medical devices for a number of reasons, including 30 its biomechanical compatibility, its biocompatibility, its fatigue resistance, its kink resistance, its uniform plastic deformation, its magnetic resonance imaging compatibility, its constant and gentle outward pressure, its dynamic interference,

CA 02944014 2016-09-30 its thermal deployment capability, its elastic deployment capability, its hysteresis characteristics and because it Is modestly radiopaque.

Nitinol, as described above, exhibits shape memory and/or superelastic characteristics. Shape memory characteristics may be simplistically described as follows. A metallic structure, for example a Nitinol tube that Is in an Austenite phase may be cooled to a temperature such that it is in the Martensite phase. Once in the Martensite, the Nitinol tube may be deformed into a particular configuration or shape by the application of stress. As long as the Nitinol tube is maintained in the Martensite phase, the Nitinol tube will remain in its deformed shape. If the Nitinol tube is heated to a temperature sufficient to cause the Nitinol tube to reach the Austenite phase, the Nitinol tube wU return to its original or programmed shape. The original shape Is programmed to be a particular ........ shape by well known., techniques. .. .Superelastic, characteristics may be simplistically described as follows. A metallic structure, for example, a Nitinol tube that is in an Austenite phase may be deformed to a particular shape or configuration by the application of mechanical energy. The application of mechanical energy causes a stress induced Martensite phase transformation. In other words, the mechanical energy causes the Nitinol tube to transform from the

Austenite phase to the Martensite phase. By utilizing the appropriate measuring instruments, one can determine that the stress from the mechanical energy causes a temperature drop in the Nitinol tube. Once the mechanical energy or stress is released, the Nitinol tube undergoes another mechanical phase transformation back to the Austenite phase and thus its original or programmed shape. As described above, the original shape is programmed by well known techniques. The Martensite and Austenite phases are common phases In many metals.

Medical devices constructed from Nitinol are typically utilized in both the

Martensite phase and/or the Austenite phase. The Martensite phase Is the tow temperature phase. A material in the Martensite phase is typically very soft and malleable. These properties make it easier to shape or configure the Nitinol Into complicated or complex structures. The Austenite phase is the high temperature

CA 02944014 2016-09-30 phase. A material in the Austenite phase is generally much stronger than the material in the Martensite phase. Typically, many medical devices are cooled to the Martensite phase for manipulation and loading into delivery systems, as described above with respect to stents and then when the device is deployed at 5 body temperature, they return to the Austenite phase.

The first, second and third stent segments 310, 320,330 are preferably seif-expandable and formed from a shape memory alloy. Such an alloy may be deformed from an original, heat-stable configuration to a second, heat-unstable 10 configuration. The application of a desired temperature causes the alloy to revert to an original heat-stable configuration. A particularly preferred shape memory alloy for this application is binary nickel titanium alloy comprising about 55.8 percent Ni by weight, commerdaly available under the trade designation —NITINOL This NiTi. alloy ..undergoes a phase transformation at physiological 15 temperatures. A stent made of this material is deformable when chilled. Thus, at low temperatures, for example, below twenty degrees centigrade, the stent is compressed so that it can be delivered to the desired location. The stent may be kept at low temperatures by circulating chilled saline solutions. The stent expands when the chilled saline is removed and it is exposed to higher 20 temperatures within the patient’s body, generally around thirty-seven degrees centigrade.

In preferred embodiments, each stent is fabricated from a single piece of alloy tubing. The tubing is laser cut, shape-set by placing the tubing on a 25 mandrel, and heat-set to Its desired expanded shape and size.

In preferred embodiments, the shape setting is performed in stages at five hundred degrees centigrade. That is, the stents are placed on sequentially larger mandrels and briefly heated to five hundred degrees centigrade. To 30 minimize grain growth, the total time of exposure to a temperature of five hundred degrees centigrade Is limited to five minutes. The stents are given their final shape set for four minutes at five hundred fifty degrees centigrade, and then aged to a temperature of four hundred seventy degrees centigrade to import the

CA 02944014 2016-09-30 proper martensite to austenite transformation temperature, then blasted, as described in detail subsequently, before electropolishing. This heat treatment process provides tor a stent that has a martensite to austenite transformation which occurs over a relatively narrow temperature range; for example, around 5 fifteen degrees centigrade.

To improve the mechanical integrity of the stent, the rough edges left by the laser cutting are removed by combination of mechanical grit blasting and electropolishing. The grit blasting is performed to remove the brittle recast layer 10 left by the laser cutting process. This layer is not readily removable by the electropolishing process, and if left intact, could lead to a brittle fracture of the stent struts. A solution of seventy percent methanol and thirty percent nitric add at a temperature of minus forty degrees centigrade or less has been shown to work effectively as an electropolishing solution. Electrical parameters of the 15 electropolishing are selected to remove approximately 0.00127 cm of material from the surfaces of the struts. The clean, electropolished surface is the final desired surface for attachment to the graft materials. This surface has been found to import good corrosion resistance, fatigue resistance, and wear resistance.

The graft material or component 600, as illustrated in Figure 6, may be made from any number of suitable biocompatible materials, including woven, knitted, sutured, extruded, or cast materials comprising polyester, polytetrafluoroethylene, sillcones, urethanes, and ultralight weight polyethylene, 25 such as that commercially available under the trade designation SPECTRA™. The materials may be porous or nonporous. Exemplary materials indude a woven polyester fabric made from DACRON™ or other suitable PET-type polymers.

In one exemplary embodiment, the fabric for the graft material is a forty denier (denier is defined in grams of nine thousand meters of a filament or yam), twenty-seven filament polyester yam, having about seventy to one-hundred end yams per cm per face and thirty-two to forty-six pick yams per cm face. At this

CA 02944014 2016-09-30 weave density, the graft material is relatively impermeable to blood flow through the wall, but is relatively thin, ranging between 0.08 and 0.12 mm in wall thickness.

The graft component 600 is a single lumen tube and preferably has a taper and flared portion woven directly from the loom, as illustrated for the endovascular graft 300 shown in Figure 3.

Prior to attachment of the graft component 600 to the stents 310, 320,

330, crimps are formed between the stent positions by placing the graft material on a shaped mandrel and thermally forming indentations in the surface. In the exemplary embodiment illustrated in Figures 3 and 6, the crimps 602 in the graft 400 are about two mm long and 0.5 mm deep. With these dimensions, the _______endovascular graft 300 can bend and flex while maintaining an open lumen.

Also, prior to attachment of the graft component 600 to the stents 310,320 330, the graft material is cut in a shape to mate with the end of each end stent.

As stated above, each of the stent segments 310, 320 and 330 is attached to the graft material 600. The graft material 600 may be attached to the 20 stent segments 310,320,330 in any number of suitable ways. In one exemplary embodiment, the graft material 600 may be attached to the stent segments 310, 320,330 by sutures.

The method of suturing stents in place Is important for minimizing the 25 relative motion or robbing between the stent struts and the graft material. Because of the pulsatile motion of the vasculature and therefore the graft system, it is possible for relative motion to occur, particularly in areas where the graft system is in a bend, or if there are residual folds in the graft material, due to being constrained by the aorta or Iliac arteries.

Ideally, each strut of each stent segment is secured to the graft material by sutures. In an exemplary embodiment, the suture material is blanket stitched to the stent segments at numerous points to securely fasten the graft material to

CA 02944014 2016-09-30 the stent segments. As stated above, a secure hold is desirable in preventing relative motion in an environment in which the graft system experiences dynamic motion arising from pulsatile blood pressure, in addition to pulsation of the arteries that are in direct mechanical contact with the graft system. The stents 5 nearest the aortic and iliac ends of the graft system (the uppermost first stent segment 310 and the third stent segment 330 respectively) are subject to the pulsatile motion arising from direct internal contact. These struts in particular should be wefl secured to the graft material. As ilustrated in Figure 6, the stitches 604 on the upper most first stent segment 310 are positioned along the 10 entire zigzag arrangement of struts. The upper and lower apexes of the third stent segment may be stitched utilizing a similar configuration. It Is difficult to manipulate the suture thread precisely around the struts that are located some distance away from an open end, accordingly, various other simpler stitches may be utilized on these struts, or no stitches may be utilized in these areas.

As illustrated in Figure 6, each of the struts in the first stent segment 310 is secured to the graft material 600 which has been cut to match the shape of the stent segment 310. The blanket stitching 604 completely encircles the strut and bites into the graft material 600. Preferably, the stitch 604 encircles the strut at 20 approximately five equally spaced locations. Each of the struts on each end of the third stent segment 330 is attached to the graft material, which has been cut to make the shape of the stent segment 330, in the same manner as the first stent segment 310.

A significant portion of the graft wil not rest directly against vascular tissue. This portion of the graft will be within the dilated aneurysm Itself. Therefore, this portion of the graft will not experience any significant pulsatile motion. For this reason, it is not necessary to secure the stent segments to the graft material as aggressively as the stent structure described above.

Therefore, only point stitches 606 are necessary for securing these stents.

It is important to note that a wide variety of sutures are available. It is equaly important to note that there are a number of alternative means for

CA 02944014 2016-09-30 attaching the graft material to the stent, including welding, gluing and chemical bonding.

As described above with respect to suturing stents in place, it is important to minimize or substantially reduce the relative motion or rubbing between the stent struts and the graft material. This relative motion arises from pulsatile blood pressure in addition to the pulsation of the arteries that are in direct mechanical contact with the graft system.

The present invention is directed to a means for attaching graft material to , stent structures in such a manner as to significantly reduce or substantially eliminate this relative motion. The means may be utilized in any of the stent structures described herein, including the stents forming the trunk section and bifurcated section of the anchoring and sealing component of the repair device and the first, second and third stent segments of the endovascular graft.

Referring to Figure 7, there Is illustrated an exemplary embodiment of a modified stent cell 700 design in accordance with the present invention. As shown, rather than a simple apex 334 as illustrated in Figure 4, foe modified 20 stent cel! 700 comprises a more complex or modified apex 702 that Is designed to more securely attach the graft to foe stent while allowing the graft material to move with the apex as is illustrated in Figures 8A and 8B and described subsequently. The modified apex 702 oomprises a tab like structure 704 and a narrow neck structure 706. This configuration allows the sutures to be 25 connected utilizing a delta stitch as described in more detai below. This modified apex 702 may comprise other suitable configurations and sizes so long as it allows for securely holding the delta stitch or any other stitch or attaching elements, and does not significantly impact the size of the overall device. The modified apex 702 may comprise radiopaque material such as tantalum and thus 30 serve a dual role as holder and marker.

Referring now to Figure 8A and 88, there is iiustrated the more complex apex 702 relative to the graft material 802 forming the particular component. In

CA 02944014 2016-09-30 both figures, the more complex modified apex 702 is secured to the graft material 802 by any suitable, non-biodegradable or non-bioeiTodable suture material 804 utilizing a delta stitch. The delta stitch is so named because when looked at as a single entity, the stitching pattern forms a substantially delta configuration. As illustrated, the delta stitch suture 804 fits around two struts 708 and the narrow neck structure 706. With this configuration, the apex itself holds two legs of the delta stitch in position, and the combination of the narrow neck structure 706 along with the tab 704 holds the third leg of the delta stitch in position. It is important to note that any stitch may be utiized and that if so desired, the stitching material may be made out of a degradable material. Utilizing a degradable stitch material allows for an acute connection, but also allows for removal of a component If desired after the material degrades.

As set forth above, this unique arrangement not only holds the graft to the stent, but also allows for movement of the graft together with the stent thereby ensuring minimal or substantially no relative movement The black square 806 of the graft material 602 is always maintained in position behind the tab 704 even though the stent structure moves and changes shape. Without this relative movement, wear Is reduced.

In an alternative exemplary embodiment the graft material itself may comprise openings for securing the more complex apex 702 Illustrated in Figures 7, 8A and 8B. With this type of configuration, no sutures or other attachment means or elements may be required. Figure 9A Blustrates a substantially 25 cylindrical section of graft material 902 comprising a plurality of openings or slits 904. These slits 904 are designed large enough for the tabs 704 of the stent to go through, but small enough to hold them in place as illustrated in Figure 9Θ with the stent struts 708 shown in phantom.

With respect to the exemplary embodiment illustrated in Figure 7, a modified apex having a protrusion was utilized; however, in alternate exemplary embodiments, no protrusion may be required. For example, Figure 10 illustrates a modified apex 1002 having a necked down region 1004 for holding a stitch or

CA 02944014 2016-09-30 other suitable holding device such as a clip or staple. Figure 11 illustrates a modeled apex 1102 having multiple holes 1104 for securing a stitch or other suitable securing devkæs. In yet another alternate exemplary embodiment Illustrated in Figure 12, a modified apex 1202 may oomprise a series of indents 5 or notches 1204 to hold the attachment means. In each of these exemplary embodiments, there is no protrusion, just simply an attachment section. In addition, although shown and described as being on every apex, the present Invention may be utilized on one, every other one or any combination of apeces.

The present Invention works more effectively on zigzag shaped structures and less effectively on closed shaped structures such as diamonds.

The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.