AU2015275263B2 - Method of making a flexible stent - Google Patents

Abstract

A method of making a flexible stent comprising: a) providing a stent having a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and having 5 stent elements; b) providing at least a portion of the length of the stent with a polymeric covering when the stent is at the smaller compacted diameter; c) puncturing slits or apertures through the covering between adjacent stent elements; wherein following diametrical expansion said slits or apertures become diamond-shaped. 72581811 (GHMatters) P84556.AU.2 22/12/15 co co m cv cv N cm C%4 CY) Cj cr) co to (MO co co (N co < w -0 co CN cv to co V- m

Description

2015275263 18 Aug 2017

METHOD OF MAKING A FLEXIBLE STENT RELATED APPLICATIONS This application claims divisional status from patent cases Australian Patent 5 Application No. 2013205751, which itself is a divisional application of Australian Patent Application No. 2009204460. The entire disclosure of Australian Patent Application No. 2013205751 and Australian Patent Application No. 2009204460 is incorporated herein by reference. Most of the disclosure of these applications is also included herein, however, reference may be made to the specification of Australian Patent Application 10 No. 2013205751 and Australian Patent Application No. 2009204460 as filed to gain further understanding of the invention claimed herein. 15 20 25 30 35 FIELD OF INVENTION The present invention relates to the field of making implantable stents BACKGROUND OF THE INVENTION The use of implantable stents in the vasculature and other body conduits has become commonplace since first proposed by Dotter in the 1960’s. These devices are required to have a small, compacted diameter for insertion into an intended body conduit and transport, typically via a catheter, to a desired site for deployment, at which site they are expanded to a larger diameter as necessary to fit interferably with the luminal surface of the body conduit. Balloon expandable stents are expanded by plastically deforming the device with an inflatable balloon on which the expandable stent was previously mounted in the compacted state, the balloon being attached to the distal end of the catheter and inflated via the catheter. Self-expanding stents are forcibly compacted to a small diameter and restrained at that diameter by a constraining sleeve or other means. Following delivery to a desired site for deployment, they are released from the restraint and spring open to contact the luminal surface of the body conduit. These devices are typically made from nitinol metal alloys and typically rely on the supereleastic and biocomptible characer of this metal. Nitinol stents that relay on the shape memory attributes of that material are also known. The evolution of implatable stents has also included the use of a tubular covering fitted to the stent, either to the outer surface, the luminal surface or to both surfaces of the stent. These covered stents have generally come to the referred to as stent-grafts. The coverings are generally of a polymeric biocompatible material such as polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE). See, for example, United States Patent No. 4,776,337 to Palmaz. -1 - 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17

The Palmaz’337 patent also describes that the covering may be optionally provided with perforations if desired for particular applications. Because of the open area provided by the perforations, such devices having perforated coverings may be considered to be a sort of hybrid stent and stent-graft, as are devices that include stent 5 frames having metallic stent elements and polymeric elements connecting, covering or otherwise being attached to the stent elements. The presence of the polymeric elements reduces the otherwise open space between the adjacent metallic stent elements, either very slightly or very substantially depending on the intended application and mechanical design. Perforated stent-grafts are also described 10 elsewhere; see, for example WOOO/42949. 2015275263 18 Aug 2017

Stents having stent elements provided with polymeric coatings or coverings are also known; see, for example, United States Patent Nos. 5,735,892 to Myers et al. and 5,968,091 to Pinchuk et al.

Generally, a fully covered stent-graft can be considered to have a surface area 15 (hereinafter Amax) equal to the outer circumference of the expanded stent multiplied by the length of the stent. For a conventional, open frame stent (as opposed to a stent-graft), the surface area represented by all of the stent elements is only a small portion of the maximum surface area Amax). The actual surface area covered by the sent, meaning the area covered by all components of the stent (including connecting 20 elements) in their deployed state, is Astent· The porosity index, or P.l. describes the open area (the portion of the maximum surface area not covered by all components of the stent assembly) as a percentage of maximum surface area, wherein: P.L =(1-(Astent/Amax))x 100%) . 25 A preferred method of measuring the actual surface area covered by the stent (Astent). involves the use of a machine provided Visicon Inspection Technologies, LLC (Napa, CA0. The Visicon Finescan™ Stent Inspection System (Visicon Finescan machine model 85) uses a 6000 pixel line scan camera to generate a flat, unrolled 30 view of a stent. In operation, the stent is mounted on a sapphire mandrel with a fine diffuse surface. This mandrel is held under the linear array camera and rotated by the system electronics and is used to trigger the linear array camera to collect a line of image data in a precise line-by-line manner. After complete revolution an entire image of the stent is acquired. When the entire stent has been imaged, the software 35 differentiates between the stent with cover and the background. The total number of picture elements (pixels) is compared to the total number of pixels associated with the stent and cover to determine Astent. Basic settings on the machine used for this type of -2- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 2015275263 18 Aug 2017 10 20 25 determination are (for example): light, 100%; exposure, 0.3ms/line; gain, 5; threshold, 50; noise filter, 20; smoothing, 4.

The open area may be a continuous single space, such as the space between windings of a single helically wound stent element. Likewise the open area may be represented by the space between multiple individual annular or ring-shaped stent elements. The open area may also be represented by the total area of multiple apertures provided by either a single stent element (e.g., as shown by Figures 1B and 2B of the United States Patent No. 4,776,337 to Palmaz) or by multiple stent elements providing multiple apertures. If multiple apertures are provided they may be of equal or unequal sizes. The use of a perforated graft covering or of polymeric elements in addition to metallic stent elements may also reduce the open area.

Stents having a porosity index of greater than 50% are considered to be substantially open stents.

In addition to the porosity index, the size of any aperture providing the open area must be considered if it is intended to cover only a portion of a stent area for a specific stent application. For multiple apertures, often the consideration must be for the largest size of any individual aperture, particularly if the apertures are to provide for a “filtering” effect whereby they control or limit the passage of biologic materials from the luminal wall into the flow space of the body conduit.

Various stent devices combining metallic stent elements with polymeric connecting elements are known; see, for example US Patent 5,507,767 to Maeda et al. Another is a stent provided with a flexible knitted sleeve having small open apertures in the fashion of chain link fencing, from InspireMD Ltd. (4 Derech Hashalom St., Tel Aviv 67892 Israel).

SUMMARY OF THE INVENTION 30 35

The invention provides a method of making a flexible stent comprising: a) providing a stent having a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; b) providing at least a portion of the length of the stent with a polymeric covering when the stent is at the smaller compacted diameter; c) puncturing slits or apertures through the covering between adjacent stent elements; wherein following diametrical expansion said slits or apertures become diamond-shaped, and said polymeric covering forms a connection between said stent elements.

In an embodiment described herein there is provided a stent comprising multiple rows of stent elements, each row of said stent elements incorporating apices -3- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 wherein an apex of one row is connected to a pair of apices of an adjacent row by a pair of film webs. 2015275263 18 Aug 2017

In another embodiment described herein there is provided a stent comprising a tubular form having a plurality of openings therethrough, said openings comprising 5 adjacent stent elements interconnected by webs.

In another embodiment described herein there is provided a stent comprising multiple stent elements incorporating a plurality of apices wherein three adjacent apices are interconnected by a pair of film webs.

In another embodiment described herein there is provided a method of making 10 a flexible stent comprising: (a) providing a stent having a length between opposing ends and having stent elements; b) providing at least a portion of the length of the stent with a polymeric covering; 15 c) puncturing slits or apertures through the covering between adjacent stent elements; d) heating the stent and polymeric covering to cause the slits or apertures to enlarge to form polymeric webs interconnecting said stent elements.

In accordance with the present invention there is also provided a method of 20 making a flexible stent, the method comprising: providing a stent having a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; providing at least a portion of the length of the stent with a polymeric covering when the stent is at the 25 smaller compacted diameter, the polymeric covering connecting said stent elements; puncturing slits through the polymeric covering between adjacent stent elements; wherein following diametrical expansion said slits become diamond-shaped apertures defined between adjacent stent elements, and wherein said polymeric covering defines flexible webs forming a connection between adjacent stent elements. 30 In accordance with the present invention there is also provided a flexible stent comprising: a stent configured to have a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; a polymeric covering forming a connection between said 35 stent elements along at least a portion of the length of the stent; wherein following diametrical expansion the polymeric covering and the stent elements are configured to define diamond-shaped openings. -4- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17

In another embodiment described herein there is provided a stent formed by the method described above and comprising multiple rows of stent elements, each row of said stent elements incorporating apices wherein an apex of one row is connected to a pair of apices of an adjacent row by a pair of said polymeric webs. 2015275263 18 Aug 2017 5 An open stent (a stent having open space through its thickness at locations between the ends of the stent) and a method of making are described. The stent incorporates flexible, preferably polymeric connecting elements (i.e., polymeric webs) into the stent wherein these connecting elements connect adjacent, spaced-apart stent elements. The flexible, preferably polymeric connecting elements provide a means for 10 keeping the stent elements equally spaced and allow the construction of a stent having good flexibility and a useful resistance to forces that may be applied to the device in vivo such as torsional forces, bending forces, axial tension or compression, or radial compression.

Preferably the spaced-apart adjacent stent elements are in the form of 15 polymeric webs. A preferred stent form is a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped stent elements may also be used. Ring shaped stent elements may be in the form of zig-zag elements creating a circumferential ring, or interconnected elements that provide diamond shaped openings in a circumferential 20 sequence when the device is diametrically expanded. Alternatively, embodiments presented that utilise the helically wound serpentine forms are preferred for many applications. The stent is preferably self-expanding (made from materials such as nitinol) but may also be made from materials suitable for balloon expandable stents (e.g., stainless steel, magnesium based alloys, magnesium, cobalt chromium alloy, 25 titanium or titanium-based alloys).

Helically wound stent frames are inherently unstable in absence of a secondary linkage connecting adjacent rows. Utilization of the described polymer web linkage to interconnect adjacent rows stabilizes the helical structure and limits axial elongation, torsion and bending while allowing a high degree of flexibility. 30 The adjacent, spaced-apart stent elements are preferably substantially circumferentially oriented, meaning that they have a general direction of orientation perpendicular to the longitudinal axis of the stent, when the stent is in a straight, unbent state. A method of making involves the application of a biocompatible polymeric 35 covering to the chosen stent form to create, temporarily, a stent-graft. The covering is preferably of a strong and thin material and may be in a tubular form, although sheet forms (e.g., relatively wide films cut into narrow tapes) are preferred for manufacturing -5- 9201110,1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 as will be described. The covering is preferably applied to the outer surface of the stent, but may be applied only to the luminal surface, or alternatively may be applied to both the luminal and abluminal (outer) surfaces of the stent. Covering both the luminal and abluminal surfaces allows for the possibility of covering substantially all of the 5 metallic surfaces of the stent with the desired polymer. The polymeric film covering is preferably a thermoplastic film, and preferably a film with strength properties that result in relatively uniform directional shrinking properties when the film is subjected to heat above its melt point. The film-covered stent graft is provided with punctures (slits or other apertures) through the thickness of the film, preferably at locations between 10 adjacent stent elements as will be further described. The punctured stent-graft is then exposed to heat above the melt temperature of the film which causes the film to shrink back from the edges of the previously created puncture, resulting in openings through the wall of the stent. These openings are of size, shape, quantity and orientation that are a result of the size, shape, quantity and orientation of the previously created 15 punctures, the amount of heat subsequently applied and the thickness and type of polymeric film used. It is apparent that these are manufacturing variables that may be controlled as desired. The resulting open area of the stent (i.e., porosity index) may cover a wide range (i.e., 30 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, or higher, or between any of these percentages). The remaining polymeric 20 film following the heating step is in the form of polymeric webs extending between the adjacent stent elements. 2015275263 18 Aug 2017

An alternate method of making also involves the application of a biocompatible polymeric covering to the chosen stent form to create, temporarily, a stent-graft. A preferable stent form in this instance would be ring shaped stent elements made from 25 a suitable balloon expandable material. The covering is similar to that described previously and may be applied to the chosen stent form similarly to the methods described in the previous section. The polymeric film covering is preferably a thermoplastic film, and preferably a film with unidirectional strength properties. The film- covered stent graft is provided with punctures (slits or other apertures) through the 30 thickness of the film, preferably at locations between adjacent stent elements as will be further described. The punctured stent graft is then exposed to heat sufficient to bond the film to the stent form. When the resulting stent is diametrically expanded, these openings are of size, shape, quantity and orientation that are a result of the size, shape, quantity, and orientation of the previously created punctures. It is apparent that 35 these are manufacturing variables that may be controlled as desired. The resulting open area of the stent (i.e., porosity index) may cover a wide range such as previously described. The remaining polymeric film following the puncturing/slitting step is in the -6- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 form of polymeric webs extending between and interconnecting the adjacent stent elements. 2015275263 18 Aug 2017

Further, the finished open frame stent may optionally be provided with another covering of polymeric graft material to create a stent-graft if desired. This graft covering 5 is easily adhered or bonded to the covering or coating that is provided over the stent elements (e.g., the wire) and forms the interconnecting webs.

The polymeric covering of these finished devices (that include a multiplicity of openings and a multiplicity of polymeric interconnecting webs) is generally continuous or substantially continuous between the stent ends, being the result of having been 10 made from a continuous sheet of film or the result using helically wrapped polymeric tape with overlapping adjacent edges that are melt-bonded together. The film covering that forms these continuous webs is well adhered to the stent elements.

Still further, these devices may be provided with coatings (preferably elutable coatings) of various therapeutic agents (e.g., heparin) by various means known in the 15 art that are suitable to the particular agent.

Stents made as described herein have good conformability enabled by the flexible interconnecting webs between adjacent stent elements that provide flexibility and anatomic apposition. They also have good flexural durability enabled by interconnecting webs between adjacent stent elements that mitigates fracture due to 20 cyclic longitudinal bending in curved anatomies. The expandable device is scalable to accommodate a range of vessel sizes (e.g. 3mm - 55mm).

The potential clinical applications of the expandable device described herein include but are not limited to: congenital defects (i.e., pulmonary artery stenosis, aortic coarctation), adjunctive aortic therapy (i.e., Type I endoleaks; aortic side branch 25 stenting), peripheral artery disease (i.e., renal and iliac artery stenosis, aneurysm, and dissection) and venous applications.

BRIEF DESCRIPTION OF THE DRAWINGS 30 Figures 1A and 1 B describe respectively a perspective view and a plan view of a helically wound serpentine wire form (previously known) of a preferred stent as described herein.

Figure 2A is a side perspective view of a portion of a helically wound serpentine wire stent provided with flexible interconnecting webs between adjacent stent 35 elements.

Figure 28 is a flattened, plan view of the stent of Figure 2A.

Figures 2C and 2D are plan views wherein each single opening shown by -7- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17

Figure 28 is replaced by multiple apertures, specifically four openings in Figure 2C and six openings in Figure 20. 2015275263 18 Aug 2017

Figure 3 is a scanning photomicrographs of a multiaxial ePTFE film useful for making the described open frame stent. 5 Figure 4 shows a side view of a partially completed stent provided with slits or punctures that are part of the process of manufacturing the device.

Figures 5A-5C show transverse cross sectional views of a stent element as it may appear for a finished stent made as described herein.

Figure 6A is a side perspective view of a balloon expandable stent (or a length 10 portion of such a stent) provided with flexible interconnecting webs between adjacent stent elements.

Figure 68 is a side perspective view of three stent rings shown without the interconnecting polymeric covering.

Figure 6C is a side perspective view -of the stent assembly comprising the stent 15 rings shown in 68 provided with the interconnecting polymeric covering.

Figure 60 is the upper left section of the stent assembly described by Figure 6C, shown as a perspective detail.

Figure 7 is a side perspective view of a balloon expandable stent (or a length portion of such a stent) provided with flexible interconnecting webs between adjacent 20 stent elements.

Figure 8 is a schematic side view of stent as it would appear when mounted on a balloon for subsequent deployment and expansion. DETAILED DESCRIPTION OF THE DRAWINGS 25

It has been noted that a variety of stent forms may be usefully provided with the flexible connecting elements taught herein. Figure 1A shows a perspective view of a stent 10 that is preferred for use as described herein. The stent 10 shown comprises a helical winding of a length of serpentine wire 18. Sequential windings of the helical 30 wound serpentine wire 18 result in spaced-apart adjacent stent elements 12. The ends 17 of wire 18 may be secured by any suitable method (e.g., welding) to the adjacent helical winding. For clarity, stent 10 is shown with a mandrel 16 extending through and beyond both ends of the stent lumen, making the side closest to the viewer visually apparent while blocking the view of the side of stent 10 furthest from the viewer. 35 Mandrel 16 is present only for clarity of visualization and is not a part of stent 10.

The helically wound serpentine wire 18 extends continuously between opposing -8- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 2015275263 18 Aug 2017 ends of stent 10, wherein opposing apices 22a and 22b formed of wire bends of relatively small radii are interconnected by straight or relatively straight wire segments 24. The apices typically "point" in directions that are substantially parallel to the longitudinal axis 19 of the mandrel 16 and the tubular form of the stent 10, with 5 alternating apices 22a and 22b pointing in opposite directions, that is, pointing to opposite ends of the stent. As shown by Figure 1 A, it is preferred that apices pointing in one direction (e.g., apices 22a) are aligned along a first common line while the apices pointing in the opposite direction (e.g., apices 22b) are aligned along a second common line that is parallel to the first common line. 10 Figure 1B shows a plan (or flattened) view of details of the serpentine wire form described by Figure 1 A; dimensions-relate to the method of making described below. Dimension 27 is considered as the height (amplitude) of adjacent opposing apices while dimension 28 is the width of adjacent opposing apices. Dimension 29 describes one full period of the serpentine form. Wire diameter 25 and bend radius 26 of the 15 apices 22 may be chosen as appropriate.

Figure 2A is a side perspective view of a portion of the length of an open-frame stent 10 wherein spaced-apart, adjacent stent elements 12 (e.g., two adjacent apices 22a connected to opposing apex 22b) are interconnected by a pair of flexible polymeric webs 32. Figure 2B shows a flattened plan view of this same construction. Openings 20 34 exist between adjacent aligned apices 22a; the particular single openings 18 are generally in the shape of a guitar pick. If one drew a line through the center of the length of an individual, randomly selected web (i.e., extending between the adjacent wire apices joined by that web), that line would preferably form an angle of between 15 and 75 degrees with respect to a line parallel with the centerline of the stent (or parallel 25 with the centerline 19 of mandrel 16 shown in Figure 1). Said otherwise, for this type of stent with elements interconnected by flexible webs 32, the webs 32 preferably are oriented at an angle to the length of the stent.

The enlarged portion of Figure 28 shows how these flexible polymeric webs 32 are narrower at the middle of their length than at the ends where they are attached to 30 the stent element (e.g. the nitinol wire). It also shows how the webs 32 preferably merge tangentially into the stent element where they are joined to and attached to the stent element.

Figures 2C and 20 are plan views wherein each single opening shown by Figure 28 is replaced by multiple apertures, specifically four openings in Figure 2C and 35 six openings in Figure 20.

While various polymeric films may be suitable for use as the stent covering (or coating) material for this device, combinations of FEP (fluorinated ethylene propylene) -9- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 2015275263 18 Aug 2017 films used in combination with ePTFE films are preferred. The preferred ePTFE films for use with these helically wound serpentine wire stents are films having multiaxial fibrillar orientations as shown by the scanning electron photomicrograph of Figure 3. It is seen how the fibrils are oriented in-all directions within the plane of the ePTFE film. 5 ePTFE films of this type may be made as taught by US Patent 7,306, 729 and US Published Patent Application 2007/0012624 to Bacino et al. Films of this same type may optionally be provided with a partial covering of a thin layer of FEP (having openings through the FEP film covering; i.e., a discontinuous covering). FEP coated ePTFE films, with either a discontinuous (porous) FEP covering (coating) or a 10 continuous (non-porous) FEP covering (coating) may be made generally as taught by US Patent 5, 735,892 to Myers et al.

Figure 4 shows a partially finished stent 13 of helically wound serpentine wire provided with a first outer (abluminal) covering of FEP film and an additional covering of multiaxial ePTFE film, wherein longitudinally oriented slits 41 have been made 15 through the film between adjacent apices of the wire that are pointed in the same direction. Heat will be applied to the device having the multiple slits 41, causing the films to shrink back toward the adjacent wire stent elements, subsequently resulting the openings in the finished stent 15 (Figure 2A). This process is described in further detail below. 20 While, as noted, various types of films may be used for the stent covering, the described ePTFE films is preferred because of its multiaxial (within the plane of the film) strength orientation. It is strong, thin, and has excellent biocompatibility. When suitable heat is applied following slitting, the film will retract (shrink back) with good uniformity to create the openings through the polymeric stent covering and to create 25 the flexible polymeric interconnecting webs between adjacent stent elements.

The flexible interconnecting webs 32 that result from this process typically are of wider width at their end points where they connect with the wire apices and are of comparatively narrower width in the middle of their lengths between the apices that they interconnect. Additionally, there may be a very thin, vestigial edge (36, Figure 2B) 30 of film that extends outwardly away from the wire 18 in the straight portions 24 that connect the apices in the same helical winding (i.e., apices 22a and 22b). Figure 5A shows a transverse cross section of the wire with this edge (taken at section 5 indicated in the plan view of Figure 2B) that shows the general appearance of the edge for a single layer of graft material applied to either the outer or inner surface of the 35 stent. Figures 5B and 5C show the transverse cross section as it would appear for a covering applied to both the inner and outer surfaces of the stent element. A preferred method of making a flexible stent is as follows. A stainless steel -10- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 mandrel of diameter equal to about the inside diameter of the intended stent is obtained. The surface of the mandrel is provided with a helical wrapping of a 1" wide tape of Kapton ® Polyimide Film (DuPont, 0.002 inch thickness). A stent of the desired length and diameter made of helically wound serpentine nitinol wire is provided (wire 5 diameter as desired). This is then wound around the Kapton covered surface of the mandrel. The end of the stent wires are secured to an adjacent winding of the stent wire using an FEP thread tied with a securing knot. The apices of the serpentine wire are aligned so that apices pointing in a common direction are aligned with and parallel to the longitudinal axis of the mandrel. The stent is then helically wrapped with a 10 covering of a single layer of FEP tape that has been cut from FEP film (0.00015 inch thickness and about 0.75 inch width), stretched tight over the outer surface of the stent with minimal overlap of adjacent edges of the FEP tape. This FEP tape is then cigarette wrapped (wrapped in a direction perpendicular to the longitudinal axis of the mandrel) with an ePTFE film of the type described previously. This wrapping may be 15 started by aligning a transverse edge of the film with the longitudinal axis of the mandrel and attaching it to the underlying FEP film by carefully melt-bonding the ePTFE film edge to the FEP using a heat source such as a clean soldering iron or appropriate equivalent. Six layers of the ePTFE film are wrapped around the outer surface of the stent and the film edge is trimmed along the length of the stent (i.e., 2015275263 18 Aug 2017 20 parallel to the longitudinal axis of the mandrel). The film edge is secured with the previously-used heat source.

Longitudinal slits 41 are created between adjacent wire apices that are pointed in the same direction as shown by Figure 4. These slits may be created by any suitable means, including the use of a scalpel blade, water jet, laser, etc. One such suitable 25 laser is a Coherent Inc., Model: GEM-100A, C02, CW (continuous wave only). Santa Clara, CA. The last row of apices at each end of the stent may be omitted from slitting if it is desired to leave these end rows covered in their entirety (i.e., in stent-graft fashion). The entire length of the wrapped stent is then provided with an additional, temporary helical wrap of the Kapton tape; the ends of this tape may be secured to the 30 surface of the mandrel beyond each end of the stent with a mechanical clip or other temporary fastener. This layer of Kapton is then tightly wrapped with a temporary helical wrap of ePTFE tape (made from an ePTFE film having a fibrillar microstructure with fibrils oriented predominately parallel to the length of the tape and wrapped with a small pitch angle so that the orientation is primarily circumferential with respect to the 35 mandrel). This ePTFE tape will provide circumferential compression to the underlying materials when suitably heated.

The above construction is them placed into a suitable convection oven set at - 11 - 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 380°C for 11 minutes, after which it is removed from the oven and allowed to cool to approximately ambient temperature. The outer layers of ePTFE film and Kapton tape are then removed. The resulting coated stent and underlying layer of Kapton tape are then carefully removed from the mandrel. The remaining layer of Kapton tape may then 5 be removed from the stent using a suitable tool such as small forceps or tweezers. Remaining film edges protruding beyond the ends of the stent may then be carefully trimmed in a transverse direction close to the end apices of the stent wire with a scalpel blade. 2015275263 18 Aug 2017

Figure 6A shows a perspective view of a balloon expandable stent 60, as it 10 appears following diametrical expansion with a balloon that is preferred for use as described herein. The stent 60 shown comprises rings 62 wherein the balloon-xpanded stent elements form multiple diamond-shaped openings 63d; stent 60 is typically comprised of one or more of these rings 62. The individual rings 62 may be constructed by any suitable means known in art but are preferably fabricated from a 15 laser cut tube. For clarity, only the side of the tubular stent 60 closest to the viewer is shown. Stent 60 is provided with a polymeric covering 66, preferably of a flexible film.

It is apparent how covering 66 interconnects the multiple rings 62 to create stent 60, via webs 32 that span the distance between apices 22a and 22b of adjacent rings 62.

While various polymeric films may be suitable for use as the stent covering (or 20 coating) material for this device; combinations of FEP (fluorinated ethylene propylene) films used in combination with ePTFE films are preferred. The preferred ePTFE film for this device is a uni-axial film having higher strength in one direction, with the direction primarily aligned with the longitudinal axis 61 of the stent prior to balloon expansion. This type of film is similar to that described in U.S. Patent No. 5,476,589. A further 25 preference would be to modify the film with an application of a discontinuous coating of FEP similar to that taught in U.S. Patent No. 6, 159,565.

The arrangement of stent rings 62 are shown in Figure 68 without polymeric covering 66 as the rings 62 would appear prior to balloon expansion. Unexpanded stent rings 62 are cut to have openings 63 which become diamond shaped openings 30 63d when expanded (as shown in Figure 6A). Stent rings 62 are placed in proximity to one another with apices 22a and 22b in a typical apex to apex alignment. It is apparent that the distance between adjacent rings 62 may be as desired.

Figure 6C illustrates the stent rings 62 as shown previously in Figure 68 with the addition of interconnecting polymeric covering 66. Webs 32, each a portion of 35 polymeric covering 66, are shown to interconnect adjacent rings 62. Figure 60 is an enlarged detail perspective view of the upper left end of stent 60 described in Figure 6C. -12- 9201110,1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17

Also shown in Figures 6C and 60 are punctures or slits 68 arranged in polymeric covering 66 along the longitudinal axis of stent 60. Figures 68-60 show the multiplicity of openings 63 and 64 formed between adjacent stent elements of stent rings 62. Slits 68 through polymeric covering 66 are formed of size and shape to 5 generally correspond with the multiplicity of openings 63 and 64 in each stent ring 62. These slits 68 may be formed by various means as previously described. Slits 68 are formed through the polymeric covering 66 that covers openings 63 that extend between opposing apices 22a and 22b (openings that are enclosed between the ends of each stent ring 62). Alternate openings 64 that extend from the middle of the length 10 of each stent ring 62 and fully to the end of each stent ring 62 (i.e. between radially adjacent apices 22a and 22a, and likewise between radially adjacent apices 22b and 22b) are also provided with slits through the covering polymeric material 66. These slits 68 extend longitudinally between adjacent rings 62 and into the corresponding opening in the adjacent ring 62. These slits 68 collectively create individual interconnecting 15 webs 32. Slits 68 may be of width as desired; the width of a scalpel blade may be 2015275263 18 Aug 2017 deemed sufficient even though the figures show that width of slit 68 corresponding to the width of the underlying stent openings 63 and 64.

The apices 22a and 22b of each ring 62 may be made to point toward one another as shown in Figure 6A or may be arranged to be offset as shown in Figure 7 20 (i.e. aligned peak-to-valley as shown in Figure 7 as opposed to being aligned in peak- to-peak fashion as shown in Figures 1A through 20, Figure 4 and Figure 6A). The apices typically "point" in directions that are substantially parallel to the longitudinal axis 61 of the tubular form of the stent 60.

Figure 8 is a schematic side view of stent 60 as it would appear mounted on a 25 balloon (not shown) for subsequent deployment and expansion. Stent 60 is preferably axially compressed during mounting so that Interconnecting webs 32 are bowed or wrinkled so that stent 60 is foreshortened. The advantage of mounting stent 60 in this fashion is that, during balloon expansion, stent rings 62 will foreshorten as they are deformed (with openings 63 becoming diamond shaped openings 63d). For example, 30 this allows for less than 10% shortening with a greater than 6 times diametrical expansion. Bowed webs 32 may be tucked under adjacent stent ring 62 if it is preferred that they do not protrude outwardly. A preferred balloon is a balloon that expands diametrically from the middle of its length toward its opposing ends. Alternatively, stent rings 62 at the ends of stent 60 may be made of a thicker material than ring 62 35 positioned closer to the middle of the length of stent 60. These alternatives result in the application of tension during expansion to bowed webs 32 thereby pulling the slack out of them, increasing their length and compensating for foreshortening of rings 62 to -13- 9201110J (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 maintain the length of stent 60. 2015275263 18 Aug 2017 A preferred method of making a stent such as a stent shown in Figures 6A through 7 is as follows. Standard diamond pattern geometry stents were laser machined and electro-polished at Laserage Technology Inc, Waukegan, IL from a 316 5 LVM stainless steel tube measuring 4.19mm diameter x ,38mm wall thickness, available from Norman Noble, Cleveland OH. The stents were exposed to a surface roughening step to improve adherence without degrading fatigue durability performance. Plasma treatment of the stents was performed prior to FEP powder coating for purposes of cleaning and reducing contact angle of the metal surface. 10 Plasma treatment was performed as commonly known in the arts. FEP powder (Daikin America, Orangeburg N.Y.) was applied to the stent component by first stirring the powder into an airborne "cloud" in a standard kitchentype blender and suspending the frame in the cloud until a uniform layer of powder was attached to the stent frame. The stent component was then subjected to a 15 thermal treatment of 320° C. for approximately three minutes. This caused the powder to melt and adhere as a coating over the stent component. Each ring was coated a second time while suspending it from the opposite end and placed in 320'C oven for 3 minutes then removed and allowed to cool to room temperature.

Seventeen layers of a thin ePTFE film provided with a discontinuous coating of 20 FEP as previously described was then wrapped around a stainless steel mandrel measuring approx 3.43mm. The film is applied with its high strength orientation parallel to the longitudinal axis of the stent and with the FEP side facing out. Individual stent rings were placed over the film tube and aligned. In this case, the stent rings were aligned apex to apex and separated evenly with a gap of about 2.5mm between each 25 ring to achieve an overall device length of about 40mm. An additional 17 layers of the same film was applied as previously described except with the FEP side oriented down, toward the outer diameter of the stent.

The entire assembly was wound with several layers of an ePTFE thread (Part# S024T4, WL Gore, Elkton, MD) to impart compressive forces to the underlying 30 construct. The assembly was placed in 320'c oven (Grieves, Model MT1000, The

Grieve Corporation, Round Lake IL) for approximately 40 minutes. The stent assembly was removed and allowed to cool to room temperature. The over-wrap was then removed and the slits were created and excess material was removed.

While particular embodiments of the present invention have been illustrated and 35 described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the -14- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17 following claims. 2015275263 18 Aug 2017

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is 5 used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the 10 common general knowledge in the art, in Australia or any other country. -15- 9201110_1 (GHMatters) P84556.AU.29201110_1 (GHMatters) P84556.AU.2 18/08/17

Claims (19)

1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. A method of making a flexible stent comprising: a) providing a stent having a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; b) providing at least a portion of the length of the stent with a polymeric covering when the stent is at the smaller compacted diameter; c) puncturing slits or apertures through the covering between adjacent stent elements; wherein following diametrical expansion said slits or apertures become diamond-shaped, and said polymeric covering forms a connection between said stent elements.
2. 2. A method according to claim 1 wherein said stent with the polymeric covering is heated to bond the polymeric covering to the stent elements prior to puncturing.
3. 3. The method according to claim 1 or claim 2, wherein said stent elements define apices oriented to point towards opposing ends of the stent.
4. 4. The method of claim 3, wherein following diametrical expansion, said polymeric covering defines webs that span a distance between said apices of adjacent stent elements.
5. 5. The method according to any one of claims 1 to 4, wherein following diametrical expansion said slits or apertures define a porosity index greater than 50%.
6. 6. The method according to any one of claims 1 to 5, wherein following diametrical expansion said slits or apertures define a porosity index greater than 80%.
7. 7. A method of making a flexible stent, the method comprising: providing a stent having a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; providing at least a portion of the length of the stent with a polymeric covering when the stent is at the smaller compacted diameter, the polymeric covering connecting said stent elements; puncturing slits through the polymeric covering between adjacent stent elements; wherein following diametrical expansion said slits become diamond-shaped apertures defined between adjacent stent elements, and wherein said polymeric covering defines flexible webs forming a connection between adjacent stent elements.
8. 8. The method of claim 7, wherein providing at least said portion of the length of the stent with said polymeric covering creates a stent-graft, and wherein puncturing slits through the polymeric covering and diametrically expanding said stent-graft forms said flexible stent.
9. 9. The method of claim 7 or claim 8, wherein said stent elements with said polymeric covering is heated to bond said polymeric covering to said stent elements prior to puncturing.
10. 10. The method of any one of claims 7 to 9, wherein said stent elements define apices pointed toward opposing ends of said stent.
11. 11. The method of claim 10, wherein following diametrical expansion, said polymeric covering defines webs that span a distance between said apices of adjacent stent elements.
12. 12. The method of claim 11, wherein said webs provide a flexible linkage between said apices of adjacent stent elements.
13. 13. A flexible stent comprising: a stent configured to have a smaller compacted diameter prior to diametrical expansion and a larger diameter following diametrical expansion, said stent having a length between opposing ends and including a plurality of distinct stent elements along said length; a polymeric covering forming a connection between said stent elements along at least a portion of the length of the stent; wherein following diametrical expansion the polymeric covering and the stent elements are configured to define diamond-shaped openings.
14. 14. The flexible stent of claim 13, wherein said stent elements comprise multiple individual spaced-apart ring-shaped stent elements.
15. 15. The flexible stent of claim 13, wherein said stent elements comprise multiple individual circumferential rings defining zig-zag elements along a circumference.
16. 16. The flexible stent of any one of claims 13 to 15, wherein said stent elements define apices pointed toward the opposing ends of said stent.
17. 17. The flexible stent of any one of claims 13 to 16, wherein said diamond-shaped apertures define apices oriented to point towards opposing ends of the stent.
18. 18. The flexible stent of any one of claims 13 to 17, wherein following diametrical expansion, said polymeric covering defines webs that span a distance between said apices of adjacent stent elements.
19. 19. The flexible stent of claim 18, wherein said webs provide a flexible linkage between said apices of adjacent stent elements.