Low profile stent graft and delivery system

Abstract

To provide stent graft systems and methods that are capable of being compressed to small size and can be safely and reliably deployed using a flexible low profile system.SOLUTION: A tubular prosthetic device implantable in a body lumen includes a first part including a tubular lumen and a second part including an attachment member. The second part is secured to the first part via various configurations. The tubular prosthetic device can be reduced to a diameter less than the diameter of traditional devices, for ease of use during implantation.SELECTED DRAWING: Figure 5B

Description

[Technical field]

[0001] The present invention relates to a system for the treatment of vascular disorders. In particular, the present invention relates to an implantable graft having a low profile attachment means.

[0002] Description of Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 61 / 621,036, filed April 6, 2012, and U.S. Provisional Patent Application No. 61 / 621,038, filed April 6, 2012, the entire contents of which are incorporated by reference herein. [Background technology]

[0003] The present invention relates to a system for disorders of the vascular system, particularly aneurysms. An aneurysm is a medical condition that is generally manifested by a dilation and weakening of the wall of a patient's aorta. Aneurysms may occur at various locations within a patient's body. A thoracic aortic aneurysm (TAA) or abdominal aortic aneurysm (AAA) is manifested by a dilation and weakening of the aorta that is generally a severe and life-threatening condition that requires intervention. Existing methods for treating aneurysms include invasive surgical procedures, including graft replacement of the diseased blood vessel or body lumen or reinforcing the blood vessel with a graft.

[0004] Surgical procedures to treat aortic aneurysms can result in relatively high morbidity and mortality rates, as well as lengthy hospital stays and painful recoveries, due to risk factors inherent in surgical repair of the disease. Due to the inherent risks and complexities of surgical repair of aortic aneurysms, endovascular repair has become a widely used alternative therapy in most cases, especially in the treatment of AAA. Early work in this field is exemplified by Lawrence, Jr. et al., "Percutaneous Endovascular Graft: Experimental Evaluation," Radiology, May 1987, and Mirich et al., "Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study," Radiology, March 1989. Commercially available endoprostheses for the endovascular treatment of AAA include the Endyrant® stent graft manufactured by Medtronic, Inc., Minneapolis, Minn., the Zenith® stent graft system marketed by Cook, Inc., Bloomington, Ind., the PowerLink® stent graft system manufactured by Endologix, Inc., Irvine, Calif., and the Excluder® stent graft system manufactured by WL Gore & Associates, Inc., Newark, Del. A commercially available stent graft for the treatment of TAAs is the TAG™ system manufactured by WL Gore & Associates, Inc.

[0005] When developing such intravascular devices via catheters or other suitable devices, it would be advantageous to provide a flexible, low profile stent graft and delivery system capable of passing through a variety of guide catheters and the potentially tortuous anatomy of a patient. Most existing endovascular devices and methods for treating aneurysms, while representing a significant technological advancement over previous devices and methods, often employ systems with relatively large transverse profiles, up to 24 French (F). The profile of the stent graft can be important in achieving a desired clinical outcome. [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Lawrence, Jr. et al., "Percutaneous Endovascular Graft: Experimental Evaluation," Radiology, May 1987. [Non-Patent Document 2] Mirich et al., "Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study," Radiology, March 1989. Summary of the Invention [Problem to be solved by the invention]

[0007] Traditional stent graft systems may include a circumferential metal ring at one end of the graft to which a stent is attached. This allows for the fixation of the stent to the graft end, but it is difficult to compress the stent graft to a small size for delivery or transportation. There is a need for a stent graft system and method that can be safely and reliably deployed using a flexible, low profile system that can be compressed to a small size. [Means for solving the problem]

[0008] In one embodiment of the present invention, a device implantable into a body lumen having a reduced implantation diameter is provided, the device comprising: (a) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluids, the first portion having a first open end and a second open end; and (b) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within the body lumen; A device is provided in which the first open end has an attachment flap that is compressible to a reduced diameter compared to a device with a circumferential attachment ring, the attachment flap having a plurality of multiple sites secured by a plurality of attachment tethers.

[0009] In another embodiment, a method of manufacturing a tubular prosthesis for delivery into a patient's body lumen is provided, comprising: (a) providing a device implantable into a body lumen with a reduced implantation diameter, the device having (i) a generally tubular first portion, a lumen for the flow of bodily fluids extending through the first portion, the first portion having a first open end and a second open end; (ii) a second portion attached to the first open end of the first portion, the second portion capable of securing the device within the body lumen, the first open end having an attachment flap compressible to a reduced diameter compared to a device with a circumferential attachment ring, the attachment flap having a plurality of multiple sites secured by a plurality of attachment tethers; and (b) delivering the device to a desired location within the body lumen. Effect of the Invention

[0010] SUMMARY OF THE PRESENT EMBODIMENTS The present invention provides a stent graft system and method that is compressible to a small size and can be safely and reliably deployed using a flexible, low profile system. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 shows an exemplary embodiment of a traditional stent mounting system. [Diagram 2] 1 is a schematic diagram of one embodiment of the present invention having a reduced size attachment flap design. [Diagram 3] 1 is a schematic diagram of an alternative embodiment of the present invention of a single point attachment means of a stent to a graft. [Figure 4] 13 is a schematic diagram of an alternative embodiment of the present invention including radially expandable rings and a means for attaching the stent to the graft. [Figure 5A] 13 is a schematic diagram of yet another embodiment of the present invention including a single point attachment of the stent to the graft using support holes and an optional tethered design. [Figure 5B]13 is a schematic diagram of yet another embodiment of the present invention including a single point attachment of the stent to the graft using support holes and an optional tethered design. [Figure 6A] FIG. 13 is a side view of yet another embodiment of the present invention including a single point attachment of the stent to the graft by a supporting roll feature. [Figure 6B] FIG. 6B is an enlarged view of the support roll feature of FIG. 6A. [Figure 7] FIG. 13 is a close-up view of yet another embodiment of the present invention including a single point attachment of the stent to the graft via a reinforced hole feature. [Figure 8A] FIG. 1 illustrates an embodiment of the present invention including a series of reinforcing tabs for securing the stent to the graft. [Figure 8B] FIG. 1 illustrates an embodiment of the present invention including a series of reinforcing tabs for securing the stent to the graft. [Figure 9] FIG. 13 illustrates an embodiment of the invention including folded graft material to secure the stent to the graft. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] SUMMARY OF THE PRESENT EMBODIMENTS The present invention generally relates to methods and devices for the treatment of fluid flow vessels within a patient's body. In particular, the present invention relates to devices designed for implantation within a patient's body vessels, which allow the flow of fluid, e.g., blood, therethrough. An exemplary prosthetic device has a first portion that is a substantially tubular member through which fluid can flow. The first portion may be referred to as a graft or graft body. The first portion is typically made of a biocompatible, substantially fluid-tight material, which may include a fabric or a polymer. For example, the first portion may be made of a material including polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). In particular, the first portion may have any number of layers of PTFE and / or ePTFE, including from about 2 to about 15 layers, having an uncompressed layered thickness of about 0.003 inches (0.076 mm) to about 0.015 inches (0.381 mm). Unless otherwise specified, the term "PTFE" as used herein includes both PTFE and ePTFE. Additionally, the graft body sections or portions of the invention described herein may comprise all PTFE, all ePTFE, or combinations thereof. Such graft body sections or portions may comprise any other biocompatible material suitable for graft applications, such as Dacron. Useful materials include, but are not limited to, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene, fluorinated ethylene propylene, polyvinyl acetate, polystyrene, poly(ethylene terephthalate), naphthalene dicarboxylate derivatives such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate, and trimethylene diol naphthalate, polyurethane, polyurea, silicone rubber, polyamide, polyimide, polycarbonate, polyaldehyde, polyether ether ketone, natural rubber, polyester copolymers, silicone, styrene-butadiene copolymers, polyethers such as fully or partially halogenated polyethers and copolymers, and combinations thereof.

[0013] Particularly useful materials include porous polytetrafluoroethylene with or without discernible node and fibril microstructures and expanded (wet expanded) PTFE layers with low or substantially zero fluid permeability and substantially free of node and fibril microstructures, including closed cell microstructures with high density regions whose grain boundaries are directly interconnected to the grain boundaries of adjacent high density regions, and porous PTFE with or without discernible node and fibril microstructures. PTFE layers lacking the separate parallel fibrils that interconnect adjacent nodes of ePTFE have no discernible node and fibril microstructures as viewed under a scanning electron microscope (SEM) at 20,000 times magnification.

[0014] A porous PTFE layer that is not or substantially not fluid permeable may have a Gurley number greater than about 12 hours, or may be essentially infinite, or may have a Gurley number that is too high to measure and does not exhibit measurable fluid permeability. 6 Some have Gurley numbers greater than 10 ...

[0015] Descriptions of various graft body configurations can be found in U.S. Pat. No. 7,125,464, entitled "Method for Manufacturing an Endovascular Graft Section," U.S. Patent Application Publication No. 2006 / 0233991, entitled "PTFE Layers and Methods of Manufacturing," and U.S. Patent Application Publication No. 2006 / 0233990, entitled "PTFE Layers and Methods of Manufacturing," which are incorporated by reference in their entireties.

[0016] The second portion of such a device may include an attachment member that may be used to secure the device to a lumen in which it is implanted. The attachment member may be secured to one or more ends of the first portion by a connector ring at least partially disposed in a wall portion of one or more ends of the first portion as described in more detail below. The attachment member may be in the form of an expandable member or stent. The attachment member may be used to anchor one end (e.g., a distal end or a proximal end) of the first portion to the vasculature of a patient. The first portion may include an optional first attachment element or ring that may be disposed adjacent one end of the first portion and that is configured to be securable to the attachment member to the first portion. The mounting member and mounting ring may be configured as, for example, any of the mounting elements described in U.S. Patent Application Publication No. 2005 / 0228484(A1), the entire contents of which are incorporated herein by reference.

[0017] In one embodiment, the second portion may include a tubular stent that joins the first portion to the lumen in which it is implanted. The stent may be self-expanding or may be expandable when subjected to a force, for example via a balloon. The stent may optionally further include barbs angled outwardly from the attachment member and configured to engage tissue in the patient's vessel wall and inhibit axial movement of the device once deployed. In use, the device is typically implanted within the lumen and held in place, at which point the stent is expanded to secure the device within the body lumen and allow fluid flow therethrough. The stent attachment means is particularly useful as it allows for quick, accurate, and safe implantation while avoiding the need to suture or otherwise surgically secure the device in place. The stent attachment member is typically secured to the first portion by an attachment ring that extends around the circumference of the first portion to secure the stent to the first portion. However, the present invention provides an apparatus that allows a second portion, including an attachment member, to be secured to a first portion without the need for a typical attachment ring.

[0018] For example, the devices disclosed herein are typically implanted in a patient's body with the use of a catheter or other implantable device that travels through a body lumen to allow for deployment of the device into the body lumen. As will be appreciated by those skilled in the art, because deployment of the device occurs through a blood vessel, the device must typically be compressed or rolled so that it has a small diameter. Prior art devices were typically only able to achieve a compressed thickness of 18 to 25 French. However, the present invention was able to achieve a very small diameter in the compressed or rolled state. The compressed or rolled diameter of the present invention is about 9 French to about 15 French, particularly about 11 French to about 14 French. The small diameter allows the device to travel safely and accurately through the body lumen. The device is typically rolled or compressed to a small diameter state and placed into a catheter and delivered through a blood vessel into position where the catheter releases the device. Thus, a small diameter is important for successful implantation. However, when the device being implanted has a fixation device, such as a stent member, attached thereto, it is often difficult to achieve the small diameter desired for implantation. This is particularly true when the first portion of the device has a circumferential attachment ring such as that shown in FIG.

[0019] FIG. 1 illustrates a traditional device having a first portion secured to a second portion by a circumferential attachment ring. As illustrated in FIG. 1, a traditional implantable device 10 includes a first portion that is a generally tubular member made of one or more fluid-tight materials as described above, and a second portion 30 that is used to secure the device 10 inside a body lumen. In embodiments that include such a separate second portion 30, the second portion 30 is typically a tubular stent member that may be made of any number of materials, including polymeric materials, metals, and combinations thereof. The second portion 30 may be joined to the first portion by fixation anchors 35, which may include eyelets, hooks, holes, snaps, "dog-bone" configurations, and combinations thereof.

[0020] As will be appreciated, the use of separate first and second portions 25, 30 in these devices 10 naturally requires a means of securing the first and second portions 20, 30 together in a manner such that the two do not become separated, either during the implantation process or after implantation is complete. To achieve this, the device 10 often includes a mounting ring 40 that is located at one or more open ends of the first portion 20 and runs around the entire circumference of the first portion 20. The mounting ring 40 is typically a continuous ring of solid material, possibly having a corrugated pattern, that extends around the entire circumference of the first portion 20. The mounting ring 40 is usually made of similar materials as the second portion 30, including solid metals and polymeric materials that help provide a secure attachment of the first and second portions 20, 30. The mounting ring 40 is typically embedded in a polymeric region located at one or more ends of the first portion 20. The second portion 30 is secured to the attachment ring 40 by a number of fixation anchors 35, which may include eyelets, hooks, holes, snaps, "dogbone" configurations, and combinations thereof.

[0021] As can be appreciated, with the circumferential attachment ring 40 extending around the entire circumference of the first portion 20 at one or more ends of the first portion 20, crushing and compression of the device 10 can be difficult to achieve. This is especially true when the attachment ring 40 is made of a solid metal or polymeric material and has a significant corrugated shape. While such devices are somewhat compressible to a reasonable size, it is often difficult and cumbersome to deploy such devices in a safe and economical manner. The present invention relates to a device having suitable means for attachment of a tubular graft to a stent member, but without the problems associated with such conventional devices as shown in FIG.

[0022] For ease of understanding, Figures 2-9 of the present application show various embodiments of attachment of a first portion to a second portion. As will be appreciated, the configuration of the first portion and / or second portion can span any desired length or shape. In the following description, the term "first portion" is intended to include a generally tubular lumen through which fluid can flow, such as a graft and / or a stent-graft. The first portion can be made of any desired material, such as PTFE, ePTFE, Dacron, and combinations thereof. The first portion can be a tubular graft with two opposing open ends, or can have three or more open ends (e.g., a bifurcated or trifurcated graft with three or more open ends). In the following description, the term "second portion" is intended to mean a means or mechanism secured to the first portion that helps secure the device within the patient. In some embodiments, the "second portion" includes an expandable stent member that may be self-expanding and expandable upon inflation of a balloon. The desired stent member may be made of any desired material, including metals and polymeric materials, and may include additional attachment features, such as barbs, hooks, etc. The second portion may have a generally mesh design, typically used in stents. In general, tubular grafts and stents are known and understood by those skilled in the art, and the present invention provides a safe and secure means of attaching the two together to form a reduced diameter device upon implantation. The reduced diameter upon implantation is beneficial in allowing for safe, precise, and reliable implantation of the device.

[0023] FIG. 2 illustrates one embodiment of the present invention, providing a device 100 that can have a low profile (low profile) when compressed. As with the exemplary devices described above, the device 100 of the present invention has a first portion 110 that is a generally tubular, fluid-flowing component having an inner lumen 115. The first portion 110 can be of any desired size or length, typically selected to be substantially similar to the internal vessel in which the device 100 is implanted. The first portion 110 can be made of any desired biocompatible material known to those skilled in the art, such as, for example, PTFE, ePTFE, Dacron, ultra-high molecular weight polyethylene, and combinations thereof. The first portion 110 can be a stent-graft if desired. The first portion 110 is tubular, with two opposing open ends defining a straight lumen, or the first portion can be split, with three or more open ends (i.e., bifurcated, trifurcated, etc.). The number of open ends of the first portion 110 is not critical and any number can be selected. For purposes of the present invention, only one open end of first portion 110 will be described, and it should be understood that the attachment means of the present invention may be provided on any or all of the open ends of first portion 110.

[0024] This embodiment has a second portion 120 located at the end of the first portion 110. A preferred configuration for the second portion includes a generally tubular open mesh design stent member. The second portion 120 may be of approximately the same diameter as the first portion 110 when expanded, or may be of a larger or smaller diameter. The second portion 120 may be made of any desired material, including, for example, metals (e.g., Nitinol), polymers, and combinations thereof. The second portion 120 may be self-expanding. In such an embodiment, the second portion 120 has a natural tendency to expand to its fully expanded state that aids in anchoring the device 100 in the body lumen. Alternatively, the second portion 120 may be expandable when a force is applied, for example, by use of an inflatable balloon or other opening means. The second portion 120 may have barbs or other components that aid in anchoring the device 100 in the body lumen, if desired. Furthermore, the second portion 120 may be of any desired length to effectively secure the device 100 in place after implantation.

[0025] In some embodiments, the first portion 110 includes at least one inflatable channel 125, which may be inflatable with a biocompatible material and may be used to aid in attachment of the device 100 to a body lumen. The inflatable channel 125 may be inflatable, for example, such that the inflatable channel is pressed against the inner surface of the body lumen in which the device is implanted, thereby providing additional securing and / or sealing of the device 100 in place. While the figures described herein each include one inflatable channel 125, it will be understood that this feature is optional and may be omitted or alternatively, two or more inflatable channels 125 may be provided.

[0026] In this first embodiment depicted in FIG. 2, the second portion 120 may be joined to the first portion 110 by a reduced size attachment flap 130. As in the prior art devices, the reduced size attachment flap 130 is used to secure the second portion 120 to the first portion 110. The reduced size attachment flap 130 is made entirely of a polymeric material, which may be made of the same material as the first portion 110 if desired. Although FIG. 2 shows the reduced size attachment flap 130 as a separate piece from the first portion 110, it will be understood that the reduced size attachment flap 130 may simply be an end of the first portion 110 without needing a separate structure. For example, the reduced size attachment flap 130 may be an end of the first portion 110 that is folded back on itself to form a cuff. As another variation, the flap 130 may be spirally wrapped around a shape forming mandrel to form the structure. Some exemplary methods of forming tubular PTFE structures are described in U.S. Patent Nos. 7,125,464 (Method and Apparatus for Manufacturing an Endovascular Graft Section), 7,090,693 (Endovascular Graft Joint and Method of Manufacture), and 6,776,604 (Method and Apparatus for Shape Forming Endovascular Graft Material), all of which are issued to Chobotov et al. and are incorporated herein by reference in their entireties. Other means of securing a first portion to a second portion include the use of a tethered configuration, which are described further below.

[0027] However, in contrast to prior art devices, the reduced size attachment flap 130 includes a series of separate ring members 135 that cooperate to extend around the first portion 110 but are not connected to one another. Each of these ring members 135 may be made of a solid material and may be made of a material similar to the full circumferential attachment rings typically used in such devices. Each of the ring members 135 is desirably embedded in a polymeric material at the open end of the first portion 110, thus ensuring fixation of the ring members 135 to the first portion 110. The ring members 135 may be generally "V" shaped, with the end of the "V" located at the open end of the attachment flap 130, although any shape may be used, such as a "U" or "W" shape.

[0028] The ring member 135 can have an elongated portion that extends beyond the edge of the attachment flap 130 and has optional fastening members 140 at the ends. It may be desirable for the second portion 120 to be secured directly to the first portion 110 without the optional fastening member 140. If used, the optional fastening member 140 can be used to secure the second portion 120 to the ring member 135 by any desired means. In one embodiment, the optional fastening member 140 can be a generally "dog-bone" type fastener that is used to connect the second portion 120 to the ring member 135. The optional fastening member 140 can include any desired attachment design, including, for example, eyelets, hooks, holes, snaps, "dog-bone" features, and combinations thereof.

[0029] The reduced sized attachment flap 130 is beneficial because it minimizes the amount of ring material in the device 100 while providing a suitable and reliable method of securing the second portion 120 (i.e., the stent member) to the first portion 110. The reduced sized attachment flap 130, which includes separate ring members 135, includes a greater amount of polymeric graft material along with a smaller amount of solid material, and thus is compressible to a greater extent than a design that includes a full circumferential ring extending around the entire circumference of the first portion 110. As discussed above, the present invention allows the device to be compressed to a compressed or rolled diameter of about 9 to about 15 French (about 3 to 5 mm), particularly about 11 to about 14 French.

[0030] In use, the second portion 120 is secured to the first portion 110 by the reduced size attachment flap 130. The device 100 can then be compressed (e.g., by rolling) to a small diameter. The compressed device 100 is fed into a catheter and guided through a body vessel to the implantation site. The device 100 is then released from the catheter at the implantation site, and the second portion 120 expands to secure the device 100 in place. The first portion 110 and the second portion 120 are joined in a secure manner by the reduced size attachment flap 130, the ring member 135, and the fixing member 140.

[0031] In another embodiment, generally depicted in FIG. 3, a device 150 is provided having a first portion 160 of generally tubular shape with a lumen 165 formed therethrough, as described above, and a second portion 170, as described above. As with the previous embodiment, the first portion 160 can be made of a biocompatible material, such as PTFE, ePTFE, Dacron, ultra-high molecular weight polyethylene, and combinations thereof. As with the previous embodiment, the second portion 170 can be a tubular stent member, but can have any desired attachment device. Furthermore, the second portion 170 of this embodiment can be provided at one or all of the open ends of the first portion 160, as described above. Additionally, the first portion 160 can have no inflatable channels at one or more ends, or can have one or more inflatable channels, which can aid in the attachment and sealing of the device 150 to the lumen in which it is implanted.

[0032] In this embodiment, the second portion 170 is secured to the first portion 160 at the attachment area 180, as described above. The attachment area 180 may be a separate piece of material or may be integrally formed with the first portion 160. In some embodiments, the attachment area 180 may simply be an end of the first portion 160, or the attachment area 180 may be an end of the first portion 160 that is folded back on itself to form a cuff. The attachment area 180 may be made of a polymeric material having distinct nodes and fibril structures, such as expanded PTFE. In this embodiment, the second portion 170 is secured to the first portion 160 by use of a series of individual attachment members 185 with a hook-like feature at one end. The second portion 170 may be secured directly to the first portion 160 or may have an optional connector 175. The optional connector 175 may include any of the forms described above (i.e., eyelets, hooks, "dog bones", etc.).

[0033] Each of the attachment members 185 has a securing feature at its end, such as a hook, barb, or other latching feature, which may be embedded in the attachment region 180. In embodiments where the attachment region 180 is made of a material having a node and fibril structure, such as expanded PTFE, the attachment region 180 will include a series of nodes and fibrils. The securing feature of the attachment members 185 extends into the attachment region 180, where it may hook onto one or more fibrils. Attachment of the securing feature to the fibrils may create a secure connection between the first portion 160 and the second portion 170.

[0034] As with the first embodiment, in use, the second portion 170 is secured to the first portion 160 by the attachment region 180. The device 150 can then be compressed (e.g., by rolling) to a small diameter. The compressed device 150 is fed into a catheter and guided through a body vessel to the implantation site. The device 150 is then released from the catheter at the implantation site, and the second portion 120 is expanded to secure the device 150 in place.

[0035] 4 illustrates a further embodiment of the present invention, which includes an implantable device 200 including a first portion 210 as described above and a second portion 220 (i.e., a stent) as described above. The first portion 210 is a graft made of a biocompatible material and generally has a lumen 215 extending therethrough that allows flow therethrough. Optionally, the first portion 210 may include one or more inflatable channels 225 that may aid in attachment and sealing to the body vessel in which the device 200 is implanted.

[0036] In this embodiment, the second portion 220 is secured to the first portion 210 by a hybrid attachment region 230. The hybrid attachment region 230 may be made of a polymeric material, such as PTFE or expanded PTFE, and may be integrally formed with the first web 210. In some embodiments, the hybrid attachment region 230 may be formed by folding an end of the first portion 210 back on itself to form a cuff. The hybrid attachment region 230 includes a reduced size ring 235 that extends around the circumference of the hybrid attachment region 230 but does not extend to the outer edge of the hybrid attachment region 230. The reduced size ring 235 is made of a material that has a tendency to expand radially outward, thus providing a means for maintaining the open end of the first portion 210 in an expanded state. The reduced size ring 235 may be made of any desired material, including, for example, a metal, such as Nitinol, or a polymeric material. The reduced sized ring 235 may be generally "W" shaped and sinusoidal in configuration. Notably, the reduced sized ring 235 is small enough that it does not interfere with compression of the device 200, yet is strong enough to aid in the expansion of the device 200 during implantation.

[0037] In addition to the reduced size ring 235, the device 200 may further include a second portion 220 with a series of individual attachment members 240 at one end. The second portion 220 is secured to the first portion 210 by the attachment members 240 as described above with reference to FIG. 3. Each of the attachment members 240 may have a securing feature, such as a hook, at its end, which is embedded in the hybrid attachment region 230. In an embodiment in which the hybrid attachment region 230 is made of a material having a node and fibril structure, such as expanded PTFE, the hybrid attachment region 230 will include a series of nodes and fibrils. The securing feature of the attachment members 240 extends into the hybrid attachment region 230, where it may hook onto one or more fibrils. The attachment of the attachment members 240 to the fibrils may create a secure connection between the first portion 210 and the second portion 220.

[0038] In some embodiments, the reduced size ring 235 may not be used to directly attach the second portion 220 to the first portion 210. Attachment of the second portion 220 to the first portion 210 may optionally be accomplished through the use of a fastening feature on the attachment member 240 secured within the hybrid attachment region 230. The reduced size ring 235 is provided to aid in the expansion of the device 200 and to maintain the end of the first portion 210 in a spread-out state, thereby allowing fluid flow through the device 200. In this embodiment, the reduced size ring 235 includes a smaller amount of metal or other rigid material than traditional devices (e.g., the device depicted in FIG. 1) and thus is compressible to a smaller diameter than traditional devices.

[0039] In some embodiments, instead of being secured by mounting member 240, second portion 220 may be secured to first portion 210 through the use of a hybrid mounting ring 230 having a supporting mounting configuration described below.

[0040] 5A and 5B show different embodiments of the device 250 using a supporting attachment configuration for securing the second portion 255 to the first portion 260, including a tethered configuration. The first portion 260 is generally described above as having a lumen 265 extending therethrough, and the first portion 260 may include an optional inflatable channel 266 as described above. The second portion 255 has a generally stent configuration as described above. This configuration includes an attachment flap 270, also as described above. The embodiment of FIG. 5A further illustrates a reinforcing filament configuration that may be useful in providing a secure low profile design. In this embodiment, the attachment flap 270 has a series of reinforcing attachment sites 275 secured by attachment tethers 280. Any number of attachment tethers 280 and attachment sites 275 may be provided along the circumference of the attachment flap 270. As can be seen, the second portion 255 is secured directly to the first portion 260. However, in some embodiments, the attachment site 275 can secure a number of optional securing members that secure the second portion 255. FIG. 5B illustrates an embodiment in which a reinforcing attachment site is not provided, but rather the tether 280 directly secures the second portion 255 at the attachment site 276, for example, by intertwining and / or weaving the tether 280 with the second portion 255, or by using a looped configuration. Additionally, the tether 280 itself can be intertwined and / or weaved with one another, or disposed one above the other. For example, one portion of the tether 280 can be placed over and / or under another portion of the tether 280. Such an over-and-under arrangement can be in the form of a braid of several portions of the tether 280. While the second portion 255 can be directly attached to the first portion 260, in some embodiments the second portion 255 can be generally secured by use of a "dog bone" or other securing configuration.

[0041] The attachment tethers 280 can be made of PTFE and / or ePTFE or any other desired material. The attachment tethers 280 can be integrally formed with the first portion 260 or can be separate features attached to the first portion 260. As can be seen in Figures 5A and 5B, each tether 280 is comprised of a first strand 280A and a second strand 280B, which are secured to either the reinforcement attachment site 275 or the anchoring site 276, respectively. The first strand 280A and the second strand 280B can be a single integral strand that forms the tether 280, for example, by looping through the attachment site 275. Alternatively, the first strand 280A and the second strand 280B can be separate pieces that are secured separately to the attachment site 275 or the anchoring site 276. The tether 280 may be comprised of a single integral piece, whereby the first strand 280A and the second strand 280B are made from a single piece. If desired, the attachment site 275 may be secured to the attachment tether 280 by use of a fluorinated ethylene propylene (FEP) dispersion, which may improve bonding. The device 250 may have a separate securing feature, such as an eyelet, at the attachment site 275 or at the securing site 276, as shown for example in FIG. 5A. In this embodiment, the tether 280 may be secured directly to the attachment site 275 by threading the second portion 255 through the eyelet. The eyelet may optionally be formed as an integral part of the second portion 255, if desired. That is, the end of the second portion 255 in contact with the first portion 260 or the attachment flap 270 may have a number of eyelets for securing the tether 280. For example, if the second portion 255 is a stent, the end of the stent may have a number of eyelets configured to allow a tether to be secured therethrough.

[0042] Alternative and / or additional fastening methods include adhesive, heat, compression, welding, sintering, and combinations thereof. Welding may include circumferential, substantially circumferential, and / or partially circumferential weld lines (not shown) provided across or partially across portions of tether 280 at some portions of attachment flap 270 and / or some portions of first portion 260. By using a tethered configuration, the tether can increase the attachment strength of the second portion. In particular, each attachment point can provide a strength of about 4 to about 10 pounds-force (lbf) (1 pound = 453.6 g). By using a multiple tethered configuration, the strength is increased by multiplying the number of tethers by their individual strength (4 to 10 lbf).

[0043] It should be understood that the device 250 may have a reduced size attachment flap 270 with supporting ring members as described above in other embodiments, including designs having a series of separate ring members for support, but where it may be desirable to use attachment sites 275 and attachment tethers 280 to secure the second portion (and vice versa).

[0044] 6B shows yet another embodiment of a low profile device including a support roll feature that provides added strength and security to the attachment. As with the previous embodiment, the device 300 has a first portion 310 which is a generally tubular prosthetic material with a lumen 315 extending therethrough, and a second portion 320 designed to secure the device 300 in place during implantation. As with the above configurations, the second portion 320 may be a stent, which may be either self-expanding or expandable under force, for example, by use of an inflatable balloon. In this embodiment, securing the second portion 320 to the first portion 310 is accomplished through the use of a series of attachment members 325 which may be part of the unitary structure forming the second portion 320. In some embodiments, the second portion 320 is secured directly to the first portion 310, while in other embodiments, the second portion may have a number of optional securing features 330 at a first end and a supporting hook 335 at a second end. The attachment member 325 may be made of any desired material, such as metals, polymers, and combinations thereof. The optional securing features 330, if provided, may include any of the securing features described above, such as eyelets, hooks, "dogbone" configurations, etc.

[0045] The support hook 335 secures the attachment member 320 to the first portion 310, which can be best seen in FIG. 6B. The second end of the attachment member 325 has a generally hook-like configuration that forms the support hook 335. The first portion 310 has a generally tubular configuration along its periphery at one end to form a support roll or lip 340. The support roll 340 may be made of the same material as the first portion 310, such as PTFE and / or ePTFE, but with a slightly larger circumference than the remainder of the first portion 310. In some embodiments, the support roll 340 is a separate part that can be attached to the first portion 310, or alternatively, the support roll 340 can be formed from the first portion 310, i.e., by rolling one end of the first portion 310 onto itself. The support roll 340 can be made of a polymeric material, although in some embodiments, the support roll 340 can also be made of a metallic material.

[0046] In use, the support hooks 335 are positioned around the support roll 340 such that the support hooks 335 are secured in place by the support roll 340. In some embodiments, the support hooks 335 extend all the way around the support roll 340, thereby providing a secure and strong attachment to the support roll. It is particularly desirable for the support roll 340 to be strong enough to withstand the pulling force of the support hooks 335 without tearing or otherwise straining.

[0047] FIG. 7 shows an attachment embodiment similar to FIG. 6, but instead of a support roll, the first portion 310 has a series of reinforcing holes 360 located at one end. In this embodiment, the end of the first portion 310 that is to be secured to the second portion (not shown) has a series of reinforcing holes 360. The reinforcing holes 360 can be formed in any desired manner and made of any desired material, such as a polymeric or metallic material. The reinforcing holes 360 are typically strong enough to withstand pulling forces without tearing or breaking. In use, a number of attachment members 370, each having a secured hook 380, are passed through the reinforcement holes 360 such that each attachment member 370 is secured within one of the reinforcement holes 360. As in the previous embodiment, the second portion (i.e., the stent) is secured to the attachment members 370 in any desired attachment configuration.

[0048] In some embodiments, instead of reinforcing holes 360, reinforcement can be achieved by a series of reinforcing tabs or similar features. The ultimate goal of this embodiment is to provide a series of separate attachment points that are strong enough to resist tearing or fraying of first portion 310 when attachment member 370 is pulled. In these embodiments, the use of a full circumferential attachment ring (e.g., as shown in FIG. 1 above) is avoided and the device can be compressed to a small diameter to allow insertion into the patient's body.

[0049] 8A and 8B show an attachment scheme using a series of reinforcement tabs 400. In such an embodiment, the first portion 390 has a series of reinforcement tabs 400 at multiple fastening points. The reinforcement tabs 400 may be located along the periphery of the first portion 390, for example at least five reinforcement tabs 400 located around the first portion 390. A reinforcement tab 400 may be present at each attachment location of the second portion (not shown) to the first portion 390.

[0050] The reinforcing tabs 400 are designed to provide a high degree of tear resistance in the axial direction. As will be appreciated by one of ordinary skill in the art, the fastening of the second portion to the first portion 390 can be accomplished by hooks or any other fastening means. However, if the second portion is pulled away from the first portion 390, the first portion 390 may tear or fray. The reinforcing tabs 400 help provide strength to the device, thus reducing the likelihood of the first portion 390 tearing or fraying.

[0051] The reinforcement tab 400 may be made of a polymeric material, such as expanded PTFE. As best seen in FIG. 8B, the reinforcement tab 400 has two different orientations of nodes and fibrils to provide a more secure attachment. In particular, the reinforcement tab 400 has a first section 410 and a second section 420 that are separated approximately midway along the reinforcement tab 400 along axis A. In use, axis A is substantially aligned with the axis of the first portion 390. The first section 410 includes a series of nodes and fibrils that are oriented in a direction offset from axis A by about 1° to about 60°. The second section 420 includes a series of nodes and fibrils that are oriented in an opposite direction to the nodes and fibrils of the first section 410 and offset from axis A by about 1° to about 60°. In another embodiment, the nodes and fibrils of the first section 410 are oriented at about 20° to about 50° offset from axis A, such as about 30° offset from axis A. Similarly, the nodes and fibrils of the second section 420 are oriented at about 20° to about 50° offset from axis A (in the opposite direction from the nodes and fibrils of the first section 410), such as about 30° offset from axis A. The angle of the nodes and fibrils of the first section 410 is approximately the same as the angle of the nodes and fibrils of the second section 420 in the opposite direction, with axis A separating sections 410, 420.

[0052] The resulting reinforcement tab 400, seen in FIG. 8B, has a series of nodes and fibrils in the first section 410 and the second section 420 offset from the axis A in opposite directions at approximately the same angle. The orientation angle of each node and fibril may be offset from the axis A by approximately 30°, such that the nodes and fibrils in the first section 410 and the nodes and fibrils in the second section 420 form an angle of approximately 60°. A second portion (not shown) may be secured to the first portion 390 at the reinforcement tab 400, and may be located at a location near the axis A of the reinforcement tab 400. In this manner, the second portion may be pulled away from the first portion 390 without risk of tearing the first portion 390.

[0053] The reinforcement tab 400 may be made as a separate piece, which may then be secured to the first portion 390 by any desired means, including, for example, lamination, gluing, threading, and combinations thereof. The reinforcement tab 400 may be made as a single, integral piece, or may be made as separate pieces that are attached to one another. If the reinforcement tab 400 is made as a single, integral piece, it may be formed by a two-stage drawing process, where the first portion 410 is drawn in a first direction, and then the second section 420 is drawn in a second direction as described above. Alternatively, the reinforcement tab 400 may be formed of two separate pieces that are attached to one another, with the first piece forming the first section 410 and the second piece forming the second section 420. In this manner, the two pieces can be stretched in their respective directions and then secured together to form a two-section reinforcement tab 400 by any desired means, including, for example, lamination, adhesive, threading, and combinations thereof.

[0054] FIG. 9 illustrates another embodiment of the invention. The device 500 includes a tethered configuration utilizing a supported attachment configuration for securing the second portion 510 to the first portion 512. The first portion 510 is, for example, a graft as described above, and generally has a lumen 514 extending therethrough, which may optionally include an inflatable channel (not shown) as described above. The second portion 510 has the general stent configuration as described above. This configuration has eyelets 518 formed at the lower apexes 524 of the second portion 510, with the tether 520 passing through the eyelets 518. As shown in FIG. 9, each of the apexes 524 has an eyelet 518, although the invention is not so limited. The tether 520 may be made of any of the materials described above and secured by any of the techniques described above. This configuration further includes a portion of graft material 516 covering at least some portion of the apexes 524, the eyelets 511, and the tether 520. The graft material 516 may be graft material from the inner surface of the graft lumen 514 or may be graft material from an inner portion, typically one or more layers of graft material laminated to the second portion 510 folded over the apexes 524, eyelets 518, and tethers 520. Although multiple tethers 520 are shown in FIG. 9, the invention is not so limited and any suitable number of tethers may be used, including just one. The portions of graft material 516 may be secured to the first portion 512, apexes 524, eyelets 518, and / or tethers 520 by any of the techniques described above. Additionally, such configurations may include radiopaque portions 522 to aid in visualization during delivery. Radiopaque portions 520 may be provided at selected apexes 524, including all apexes 524 if desired. The radiopaque portion 520 may be disposed under the graft material 516 as shown, or may be disposed over a portion of the second portion 510 that is not covered by the graft material 516. The radiopaque portion 520 may be in the form of a radiopaque marker.

[0055] Each of the above-described embodiments can be implanted in a patient's body by any desired method, including, for example, the use of an insertion catheter. The device is first compressed, for example by rolling, to a small diameter and then inserted into a catheter where it is held in a compressed state until implantation. The catheter is inserted into the patient's body lumen and the implantable device is withdrawn from the catheter. The second portion (i.e., the stent) is expanded, thus anchoring the device within the body lumen.

[0056] If desired, the implantable devices described herein can have a second portion at only one open end of the first portion or at all open ends. For example, if the first portion is a tubular graft, the second portion can be provided at both the proximal and distal ends of the first portion using one or more of the attachment configurations described above. Additionally, if the first portion is a device having three or more open ends (i.e., a bifurcated or trifurcated device), any or all of the open ends can have an attachment flap and a second portion using one or more of the attachment configurations described above. For example, the first open end of the implantable device can have the second attachment configuration and the second open end of the implantable device can have the attachment configuration of FIG. 7. Any combination of the attachment configurations described above can be used as desired.

[0057] The following embodiments or aspects of the invention can be combined in any way and in any combination within the scope of the present invention as follows: [Embodiment 1] 1. A device implantable into a body lumen having a reduced implantation diameter, comprising: (a) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluid, the first portion having a first open end and a second open end; (b) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within a body lumen; The first open end has an attachment flap compressible to a reduced diameter compared to an instrument with a circumferential attachment ring, the attachment flap having a plurality of portions secured by a plurality of attachment tethers. [Embodiment 2] The device of embodiment 1, wherein the second portion is secured to the first portion at the attachment site. [Embodiment 3] The device of embodiment 1, wherein said attachment sites are secured to said attachment tethers through the use of a FEP dispersion. [Embodiment 4] The device of embodiment 1, wherein the attachment sites are secured to the attachment tethers by a thermocompression, welding or sintering process. [Embodiment 5] The device of embodiment 1, wherein the attachment tether is made of PTFE, ePTFE, or combinations thereof. [Embodiment 6] The device of embodiment 1, wherein each of the attachment sites has an individual hole provided through the attachment strap. [Embodiment 7] The device of embodiment 1, wherein each of the attachment sites comprises a physical interlock of the second portion and the tether. [Embodiment 8] The device of embodiment 1, wherein the attachment tether is secured to the second portion by passing through an eyelet in the second portion. [Embodiment Item 9] The device of embodiment 8, wherein material from an inner portion of the first portion is folded over the eyelet of the second portion. [Embodiment 10] 1. A method of manufacturing a tubular prosthesis for delivery into a body lumen of a patient, comprising: (a) providing a device implantable into a body lumen having a reduced implantation diameter, the device comprising: (i) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluid, the first portion having a first open end and a second open end; (ii) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within a body lumen; the first open end has an attachment flap that is compressible to a reduced diameter compared to an instrument with a circumferential attachment ring; (b) providing a plurality of attachment sites at the attachment flap, the attachment sites including a plurality of tethers securing the first portion and the second portion to one another; (c) securing the first portion and the second portion to one another at the plurality of attachment sites. [Embodiment 11] The method of embodiment 10, wherein the second portion is secured to the first portion at the attachment site. [Embodiment 12] The method of embodiment 10, wherein said attachment sites are secured to said attachment tethers through the use of a FEP dispersion. [Embodiment 13] The method of embodiment 10, wherein the attachment tether is made of PTFE, ePTFE, or combinations thereof. [Embodiment 14] The method of embodiment 10, wherein each of the attachment sites has a respective hole provided through the attachment strap. [Embodiment 15] The method of embodiment 10, wherein each of the attachment sites comprises a physical interlock of the second portion and the tether. [Embodiment 16] The method of embodiment 10, wherein the attachment tether is secured to the second portion by passing through an eyelet in the second portion. [Embodiment 17] The method of embodiment 10, wherein material from an inner portion of the first portion is folded back over the eyelet of the second portion. [Embodiment 18] 1. A method of manufacturing a tubular prosthesis for delivery into a body lumen of a patient, comprising: (a) providing a device implantable into a body lumen having a reduced implantation diameter, the device comprising: (i) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluid, the first portion having a first open end and a second open end; (ii) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within a body lumen; the first open end has an attachment flap compressible to a reduced diameter compared to a device with a circumferential attachment ring, the attachment flap having a plurality of portions secured by a plurality of attachment tethers; (b) delivering the device to a desired location within the body lumen. [Embodiment 19] 1. A device implantable into a body lumen having a reduced implantation diameter, comprising: (a) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluid, the first portion having a first open end and a second open end; (b) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within a body lumen; The first open end of the instrument has an attachment flap that is compressible to a reduced diameter as compared to an instrument with a full circumferential attachment ring. [Embodiment 20] 20. The device of embodiment 19, wherein the device is collapsible during implantation to a diameter of about 3 mm to about 5 mm (about 9F (French) to about 15F). [Embodiment 21] The device of embodiment 19, wherein the attachment flap has a plurality of separate ring members that cooperate to extend around the periphery of the attachment flap. [Embodiment 22] The device of embodiment 21, wherein each of the separate ring members is generally "V" shaped. [Embodiment 23] 22. The device of embodiment 21, wherein the second portion is secured to the first portion by attachment to the separate ring members. [Embodiment 24] The device of embodiment 19, wherein the attachment flap is made of a polymeric material including at least one reinforcing section. [Embodiment 25] 25. The device of embodiment 24, wherein the second portion has a plurality of individual attachment members with a hook-like feature at one end. [Embodiment 26] 26. The device of embodiment 25, wherein each of the attachment members having a hook-like feature at one end is secured to the attachment flap by securing the hook-like feature within the at least one reinforcing section. [Embodiment 27] 25. The device of embodiment 24, wherein the attachment flap has a plurality of reinforcing sections disposed along the periphery of the attachment flap. [Embodiment 28] 28. The device of embodiment 27, wherein the second portion has a plurality of individual attachment members with a hook-like feature at one end. [Embodiment 29] The device of embodiment 28, wherein each of the attachment members having a hook-like feature at one end is secured to the attachment flap by securing the hook-like feature within the reinforcement section. [Embodiment 30] The device of embodiment 19, wherein the attachment flap has a support roll at the open end. [Embodiment 31] 31. The device of embodiment 30, wherein the support roll has a ring of polymeric material disposed about the entire periphery of the open end, the ring of polymeric material having an outer diameter greater than an outer diameter of the attachment flap. [Embodiment 32] The device of embodiment 30, further comprising a plurality of attachment members, each of said attachment members having a fixation feature at a first end and a support hook at a second end. [Embodiment 33] 33. The device of embodiment 32, wherein the support hooks are disposed around the support roll, and the support hooks are secured to the attachment flaps. [Embodiment 34] 34. The device of embodiment 33, wherein the second portion is secured to the securing feature of the mounting member. [Embodiment 35] 20. The device of embodiment 19, wherein the attachment flap has a plurality of reinforcing holes. [Embodiment 36] 36. The device of embodiment 35, wherein the plurality of reinforcing holes are disposed along a periphery of the attachment flap. [Embodiment 37] The device of embodiment 30, further comprising a plurality of attachment members, each of said attachment members having a fixation feature at a first end and a support hook at a second end. [Embodiment 38] 38. The device of embodiment 37, wherein each of the support hooks is disposed within a respective one of the reinforcement holes, and each of the support hooks is secured to the attachment flap. [Embodiment 39] 38. The device of embodiment 37, wherein the second portion is secured to the securing feature of the mounting member. [Embodiment 40] 1. A method of manufacturing a tubular prosthesis for delivery into a body lumen of a patient, comprising: (a) providing a device implantable into a body lumen having a reduced implantation diameter, the device comprising: (i) a generally tubular first portion having a lumen extending therethrough for flow of bodily fluid, the first portion having a first open end and a second open end; (ii) a second portion attached to the first open end of the first portion, the second portion capable of anchoring the device within a body lumen; the first open end has an attachment flap that is compressible to a reduced diameter compared to an instrument with a circumferential attachment ring; (b) delivering the device to a desired location within the body lumen. [Embodiment 41] The method of embodiment 40, wherein the device is collapsible during implantation to a diameter of about 3 mm to about 5 mm (about 9F (French) to about 15F). [Embodiment 42] The method of embodiment 40, wherein the attachment flap has a plurality of separate ring members that cooperate to extend around the periphery of the attachment flap. [Embodiment 43] The method of embodiment 42, wherein each of the separate ring members is generally "V" shaped. [Embodiment 44] The method of embodiment 42, wherein the second portion is secured to the first portion by attachment to the separate ring members. [Embodiment 45] The method of embodiment 42, wherein the attachment flap is made of a polymeric material including at least one reinforcing section. [Embodiment 46] The method of embodiment 45, wherein the second portion has a plurality of individual attachment members with a hook-like feature at one end. [Embodiment 47] The method of embodiment 46, wherein each of the attachment members having a hook-like feature at one end is secured to the attachment flap by securing the hook-like feature within the at least one reinforcing section. [Embodiment 48] The method of embodiment 44, wherein the attachment flap has a plurality of reinforcing sections disposed along a perimeter of the attachment flap. [Embodiment 49] The method of embodiment 48, wherein the second portion has a plurality of individual attachment members with a hook-like feature at one end. [Embodiment 50] The method of embodiment 49, wherein the individual attachment members having a hook-like feature at one end are secured to the attachment flap by securing the hook-like feature within the reinforcement section. [Embodiment 51] The method of embodiment 40, wherein the attachment flap has a support roll at the open end. [Embodiment 52] The method of embodiment 51, wherein the support roll has a ring of polymeric material disposed about the entire periphery of the open end, the ring of polymeric material having an outer diameter greater than an outer diameter of the attachment flap. [Embodiment 53] The method of embodiment 51, further comprising a plurality of mounting members, each of said mounting members having a securing feature at a first end and a support hook at a second end. [Embodiment 54] The method of embodiment 53, wherein the support hooks are disposed around the support roll, and the support hooks are secured to the attachment flap. [Embodiment 55] The method of embodiment 54, wherein the second portion is secured to the securing feature of the mounting member. [Embodiment 56] The method of embodiment 40, wherein the attachment flap has a plurality of reinforcing holes. [Embodiment 57] The method of embodiment 56, wherein the plurality of reinforcing holes are disposed along a perimeter of the attachment flap. [Embodiment 58] The method of embodiment 57, further comprising a plurality of mounting members, each of said mounting members having a securing feature at a first end and a support hook at a second end. [Embodiment 59] The method of embodiment 58, wherein each of the support hooks is positioned within a respective one of the reinforcement holes, and each of the support hooks is secured to the attachment flap. [Embodiment 60] The method of embodiment 58, wherein the second portion is secured to the securing feature of the mounting member.

[0058] The various embodiments described herein are useful for enabling prosthetic devices to be implanted in relatively tight spaces (e.g., body lumens) in a safe and secure manner. Enabling compression of such devices to reduce the diameter of the device during implantation is an important and effective means for safely implanting such devices within a patient's body.

[0059] While various embodiments of the present invention have been specifically illustrated and / or described herein, it will be understood that modifications and variations of the present invention may be made by one skilled in the art without departing from the spirit and intended scope of the present invention. For example, the reinforcement holes and / or eyelets may have any suitable configuration to receive the attachment members and / or tethers, including, but not limited to, the size and shape of the holes or the size and shape of the orifices of the reinforcement holes and / or eyelets through which the attachment members and / or tethers pass. For example, the geometry of the attachment members and / or tethers may vary. Additionally, modifications of the reinforcement tabs and / or graft material to provide reinforcements including weld lines are within the scope of the present invention. Furthermore, any of the embodiments or aspects of the present invention described in the claims or herein may be used together without limiting the present invention.

Claims

1. 1. A device for implantation into a body lumen having a low profile implantation diameter, comprising: an expandable stent member having at least one end, the at least one end having an apex, each of the apexes having an eyelet disposed thereon, the stent member being capable of anchoring the device within a body lumen; one or more attachment tethers looped through each of said eyelets; a generally tubular graft having a lumen extending therethrough for the flow of bodily fluids, the graft comprising a first open end, a second open end, and a graft wall having an inner graft layer defining an inner surface of the tubular graft and an opposing outer graft layer defining an outer surface of the tubular graft, the graft wall further comprising a plurality of additional layers disposed between the inner graft layer and the opposing outer graft layer, the apex having the eyelets and the one or more attachment tethers being disposed on a portion of the outer surface of the graft proximate the first open end of the graft; and an attachment flap; material from at least one of the inner additional layers forming the graft wall is extended and folded over the first end to define the attachment flap covering the eyelet, covering the apex having the eyelet, and covering at least a portion of the one or more attachment tethers; The attachment flap is secured over a portion of the exterior surface of the graft adjacent the first open end and over at least a portion of the one or more attachment tethers to define a plurality of attachment sites thereon.

2. The device of claim 1 , wherein the attachment flaps are secured to the attachment tethers and to the portion of the exterior surface of the graft by welding.

3. The device of claim 1 , wherein the attachment tether is made of PTFE, ePTFE, or a combination thereof.

4. 1. A method of manufacturing a tubular prosthesis for delivery into a body lumen of a patient, comprising: Providing an instrument for implantation into a body lumen having a low profile implantation diameter, the instrument comprising: an expandable stent member having at least one end, the at least one end having an apex, each of the apexes having an eyelet disposed thereon, the stent member being capable of anchoring the device within a body lumen; one or more attachment tethers looped through said eyelets; a generally tubular graft having a lumen extending therethrough for the flow of bodily fluids, the graft comprising a first open end, a second open end, and a graft wall having an inner graft layer defining an inner surface of the tubular graft and an opposing outer graft layer defining an outer surface of the tubular graft, the graft wall further comprising a plurality of additional layers disposed between the inner graft layer and the opposing outer graft layer, the graft having an apex with the eyelets and the one or more attachment tethers disposed on a portion of the outer surface of the graft proximate the first open end of the graft; the first open end of the graft having an attachment flap; material from at least one of the additional layers forming the graft wall is extended and folded over the first end to define the attachment flap covering the eyelet, covering the apex having the eyelet, and covering at least a portion of the one or more attachment tethers; further comprising disposing the eyelet, the apex having the eyelet, and the one or more attachment tethers on a portion of the exterior surface of the graft adjacent the first open end of the graft; and securing the attachment flap over the portion of the exterior surface of the graft near the first open end and over at least a portion of the one or more attachment tethers to define a plurality of attachment sites.

5. The method of claim 4 , wherein the attachment tether is comprised of PTFE, ePTFE, or a combination thereof.

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