MIXED FRAME ENDOLUMENAL PROSTHESIS AND METHODS THEREOF - Patent application

Abstract

An intraluminal prosthesis (100) and method for treating at least portal hypertension are disclosed. The intraluminal prosthesis (100) includes a hybrid frame of a main frame (110) and an end frame (120), and at least a tubular graft (130) on the main frame (110). The main frame (110) includes a plurality of annular members (112). Each annular member (112) includes a plurality of diamond-shaped cells (114). The end frame (120) includes braided struts (122). The end frame (120) includes a coupling end (124) coupled to at least one of a first end annular member (112a) or a second end annular member (112b) located at a first end (110a) or a second end (110b), respectively, of the main frame (110). The tubular graft (130) extends from the first end annular member (112a) to the second end annular member (112b). The endoluminal prosthesis (100) includes an insertion state for inserting the endoluminal prosthesis (100) and an expanded state for using the endoluminal prosthesis (100).

Description

Background Art

[0001]

[0001] In the case of a healthy person, the blood flowing from the stomach, esophagus, or intestine first passes through the liver. For example, in the case of an unhealthy person suffering from liver damage, there may be obstacles that restrict blood flow, and thus the blood cannot easily flow through the liver. Such a condition is known as portal hypertension. Common causes of portal hypertension include excessive alcohol intake, thrombosis in the vein flowing from the liver to the heart, excessive iron in the liver (e.g., hemochromatosis), hepatitis B, or hepatitis C. When portal hypertension occurs, the pressure in the portal vein increases due to obstacles that restrict blood flow, which may cause rupture of the portal vein and severe bleeding. Patients with portal hypertension may also have bleeding from the veins of the stomach, esophagus, or intestine (e.g., variceal bleeding), accumulation of body fluids in the abdominal cavity (e.g., ascites), or accumulation of body fluids in the thoracic cavity (e.g., hydrothorax). At least an intraluminal prosthesis for treating portal hypertension and a method thereof are disclosed herein.

Summary of the Invention

Means for Solving the Problems

[0002]

[0002] An intraluminal prosthesis having an inserted state and an expanded state is disclosed herein. In some embodiments, the intraluminal prosthesis includes a main frame, a terminal frame, and a tubular graft. The main frame includes a plurality of annular members. Each annular member includes a plurality of diamond-shaped cells. The terminal frame includes braided struts. The terminal frame includes a connecting end coupled to at least one of a first end annular member or a second end annular member, each of which is located at a first end or a second end of the main frame. The tubular graft is located on the main frame. The tubular graft extends from the first end annular member to the second end annular member.

[0003]

[0003] In some embodiments, the distal frame includes an unconnected end at a position opposite the connected end. In the expanded state of the endoluminal prosthesis, the diameter of the unconnected end is larger than the diameter of the main frame.

[0004]

[0004] In some embodiments, the unconnected end includes an odd number of tantalum keys covering the braided struts. To facilitate identification of the tantalum keys by fluoroscopy, the width of the tantalum keys is larger than the width of the braided struts.

[0005]

[0005] In some embodiments, each annular member includes a plurality of "S"-shaped struts forming diamond-shaped cells. Each "S"-shaped strut includes a cross-sectional shape surrounded by two parallel arcs and two polynomial curves.

[0006]

[0006] In some embodiments, any two adjacent annular members are joined together only by a flexible coupling provided by a tubular graft over the two adjacent annular members.

[0007]

[0007] In some embodiments, the flexible coupling around any two adjacent annular members enables the endoluminal prosthesis to maintain the same length regardless of whether the endoluminal prosthesis is in the inserted state or the expanded state.

[0008]

[0008] In some embodiments, the flexible coupling provides flexibility to the main frame around any two adjacent annular members.

[0009] In some embodiments, the tubular graft prevents ingrowth of tissue inside the main frame, thereby maintaining the flexibility of the main frame.

[0009]

[0010] In some embodiments, the tubular graft is high density polyethylene ("HDPE") or expanded polytetrafluoroethylene ("ePTFE").

[0011] In some embodiments, both the main frame and the distal frame are nitinol.

[0010]

[0012] Also, in some embodiments, an intraluminal prosthesis is disclosed that includes a main frame, a hybrid frame of a pair of end frames, and a tubular graft. The main frame includes a plurality of physically distinct annular members. Each annular member includes a plurality of "S"-shaped struts that form a plurality of diamond-shaped cells. The pair of end frames includes woven struts. Each end frame includes a coupling end coupled to only one of a first end annular member or a second end annular member that is respectively located at a first end or a second end of the main frame. The tubular graft is located over the main frame. The tubular graft extends from the first end annular member to the second end annular member.

[0011]

[0013] In some embodiments, each end frame includes an uncoupled end opposite the coupling end. The uncoupled end includes an odd number of tantalum keys that cover the woven struts. To facilitate identification of the tantalum keys by fluoroscopy, the width of the tantalum keys is greater than the width of the woven struts.

[0012]

[0014] In some embodiments, any two adjacent annular members are coupled together only by a flexible coupling provided by the tubular graft over the two adjacent annular members.

[0013]

[0015] In some embodiments, the tubular graft is high density polyethylene ("HDPE") configured to prevent ingrowth of tissue inside the main frame and thereby maintain flexibility of the main frame around the annular members.

[0014]

[0016] In some embodiments, the length L of the main frame is given by Equation 1 L = ML 1 +(M - 1)S (Equation 1) wherein, in the above formula, M is the number of annular members, L 1 is the longitudinal dimension of the diamond-shaped cell, and S is given by Equation 2

[0015]

Number

[0016] is determined according to, and in the above formula, L 2 is the equation 3 L 2 = πD 1 / N (Equation 3) is the short dimension of the diamond-shaped cell determined according to, and in the above formula, D 1 is the diameter of the main frame in the inserted or expanded state of the intraluminal prosthesis, and N is the number of diamond-shaped cells in each annular member.

[0017]

[0017] Also, a method for a hybrid frame intraluminal prosthesis is disclosed herein, which method, in some embodiments, forms the main frame of the hybrid frame by fixing and attaching a plurality of physically distinct annular members to a tubular graft, each annular member including a plurality of "S"-shaped struts forming a plurality of diamond-shaped cells, forming, and at a first end of the main frame, knitting a first set of struts into a first end annular member to form a first end frame, and at a second end of the main frame, knitting a second set of struts into a second end annular member to form a second end frame, thereby forming a pair of end frames of the hybrid frame, and fixing the ends of each set of struts together with a tantalum key suitable for its identification by a radiation transmission method.

[0018]

[0018] In some embodiments, the method further includes, when forming the main frame, arranging each annular member longitudinally with respect to the previous annular member and then attaching it to the tubular graft, thereby ensuring the flexibility of the flexible connection between the annular members provided by the tubular graft.

[0019]

[0019] In some embodiments, fixing and attaching the annular member to the tubular graft includes inserting the annular member into the tubular graft and then attaching it to the tubular graft, or sandwiching the annular member between this tubular graft and another tubular graft and then attaching it to any of the tubular grafts.

[0020]

[0020] In some embodiments, fixing the ends of each set of struts together with tantalum keys includes fixing the ends of each set of struts together so as to obtain an odd number of tantalum keys.

[0021]

[0021] In some embodiments, the method further includes fixing together any remaining ends of each set of struts without tantalum keys to achieve an odd number of tantalum keys.

[0022]

[0022] The above and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which disclose specific embodiments of such concepts in more detail.

Brief Description of the Drawings

[0023]

Figure 1

[0023] It is a diagram showing an intraluminal prosthesis in the portal vein according to some embodiments.

Figure 2A

[0024] It is a side view of an intraluminal prosthesis according to some embodiments.

Figure 2B

[0025] It is an enlarged view of the intraluminal prosthesis of Figure 2A around the joint between the end frame of the intraluminal prosthesis and the annular member of the main frame.

Figure 3

[0026] It is a diagram showing the annular member of the main frame of an intraluminal prosthesis according to some embodiments.

Figure 4

[0027] It is a diagram showing the diamond-shaped cell of the annular member of the main frame of an intraluminal prosthesis according to some embodiments.

Figure 5

[0028] Cross-sectional view of a strut of an annular member of a luminal prosthesis according to some embodiments.

Figure 6A

[0029] A diagram showing the stress distribution in an annular member of a prior art luminal prosthesis.

Figure 6B

[0030] A diagram showing the stress distribution in an annular member of a luminal prosthesis according to some embodiments.

Figure 7A

[0031] A diagram showing a plot of von Mises stress in a prior art annular member as a function of displacement.

Figure 7B

[0032] A diagram showing a plot of von Mises stress in an annular member according to some embodiments as a function of displacement.

Figure 8A

[0033] A diagram showing the stress distribution and displacement in a prior art annular member.

Figure 8B

[0034] A diagram showing the stress distribution and displacement in an annular member according to some embodiments.

Figure 9A

[0035] A diagram showing a plot of state variables for a prior art annular member as a function of displacement.

Figure 9B

[0036] A diagram showing a plot of state variables for an annular member according to some embodiments as a function of displacement. DETAILED DESCRIPTION OF THE INVENTION

[0024]

[0037] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. The specific embodiments disclosed herein can be readily separated from the specific embodiments and can optionally be combined with any of the features of a plurality of other embodiments disclosed herein or can have features that can replace such features.

[0025]

[0038] Regarding the terms used in this specification, it should also be understood that these terms are for the purpose of describing some specific embodiments and do not limit the scope of the concepts provided in this specification. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not give limitations regarding order or numerical value. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps does not necessarily have to be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used for convenience and are not intended to imply, for example, any specific fixed location, orientation, or direction. Instead, such labels are used, for example, to reflect relative location, orientation, or direction. Unless otherwise clearly indicated in the context, the singular forms "a", "an", and "the" also include plural references.

[0026]

[0039] For example, the "proximal", "proximal portion", or "proximal end" of a catheter disclosed herein includes the portion of the catheter that is intended to be located near the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be located near the clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be located near the clinician when the catheter is used in a patient. The proximal portion, proximal end, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end, or proximal length of a catheter does not necessarily have to include the proximal end of the catheter. That is, unless otherwise suggested in the context, the proximal portion, proximal end, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0027]

[0040] For example, the "distal", "distal portion", or "distal end" of the catheter disclosed in this specification includes the portion of the catheter that is intended to be located near or within the patient when the catheter is used in the patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that is intended to be located near or within the patient when the catheter is used in the patient. For example, the "distal end" of the catheter includes the end of the catheter that is intended to be located near or within the patient when the catheter is used in the patient. The distal portion, distal end, or distal length of the catheter can include the distal end of the catheter, but the distal portion, distal end, or distal length of the catheter does not necessarily have to include the distal end of the catheter. That is, unless otherwise indicated by context, the distal portion, distal end, or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0028]

[0041] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art.

[0042] In the case of a healthy person, blood flowing from the stomach, esophagus, or intestine first passes through the liver. For example, in the case of an unhealthy person suffering from liver impairment, there may be an obstacle that restricts blood flow, and thus blood cannot easily flow through the liver. Such a condition is known as portal hypertension. Common causes of portal hypertension include excessive alcohol intake, thrombosis in the vein flowing from the liver to the heart, excessive iron in the liver (e.g., hemochromatosis), hepatitis B, or hepatitis C. When portal hypertension occurs, the pressure in the portal vein increases due to the obstacle restricting blood flow, which may cause rupture of the portal vein and severe bleeding. Patients with portal hypertension may also have bleeding from the veins of the stomach, esophagus, or intestine (e.g., variceal bleeding), accumulation of body fluids in the abdominal cavity (e.g., ascites), or accumulation of body fluids in the thoracic cavity (e.g., hydrothorax). At least an intraluminal prosthesis and its method for treating portal hypertension are disclosed in this specification.

[0029]

[0043] FIG. 1 shows an intraluminal prosthesis 100 or a transjugular intrahepatic portosystemic shunt (``TIPS'') 100 within the portal vein PV that carries blood to the liver L according to some embodiments. The intraluminal prosthesis 100 that a clinician can place within the portal vein PV in a placement procedure using a percutaneous catheter delivery system restores the patency of the portal vein PV so that blood can flow easily through the liver without being obstructed by an obstacle that restricts blood flow.

[0030]

[0044] FIG. 2A shows a side view of the intraluminal prosthesis 100 according to some embodiments, and FIG. 2B shows an enlarged view of the intraluminal prosthesis 100 around the braided connection portion 125 between the end frame 120 of the intraluminal prosthesis 100 and the annular member 112 of the main frame 110. FIG. 3 shows the annular member 112 of the main frame 110 according to some embodiments. FIG. 4 shows the diamond-shaped cell 114 of the annular member 112 according to some embodiments. FIG. 5 shows a cross-sectional view of the strut 116 of the annular member 112 according to some embodiments.

[0031]

[0045] As shown in FIGS. 2A and 2B, the intraluminal prosthesis 100 includes a hybrid frame of a main frame 110 and an end frame 120, each described in further detail herein, and a tubular graft 130 over the main frame 110. Although not shown in FIGS. 2A and 2B, the intraluminal prosthesis 100 includes an insertion state or a compressed state for advancing the intraluminal prosthesis 100 through the patient's vascular structure to the portal vein PV. The intraluminal prosthesis 100 also includes an expanded state for placing the intraluminal prosthesis 100 within the portal vein PV. The intraluminal prosthesis 100 can be self-expanding since it can expand itself from the insertion state to the expanded state.

[0032]

[0046] The main frame 110 includes, for example, a plurality of Nitinol annular members 112 spaced longitudinally from each other, or is formed from such a plurality of annular members 112. For example, the first end annular member 112a is located at the first end 110a of the main frame 110, and the second end annular member 112b is located at the second end 110b of the main frame 110.

[0033]

[0047] Each annular member 112 includes a plurality of diamond-shaped cells 114, and one of the diamond-shaped cells 114 is shown in FIG. 4. The diamond-shaped cell 114 has a long dimension L 1 and a short dimension L 2 that can vary. In the annular member 112 shown in FIG. 3, the diamond-shaped cells 114 are joined together by vertices along the short dimension L 2 to form the annular member 112. The longitudinal spacing between the annular members 112 within the main frame 110 depends in part on whether the dimension is longitudinal with respect to the intraluminal prosthesis 100, the long dimension L 1 or the short dimension L 2 of the diamond-shaped cell 114.

[0034]

[0048] Each annular member 112 also includes a plurality of "S"-shaped struts 116 that form the diamond-shaped cells 114. As shown in FIG. 5, each "S"-shaped strut 116 includes a cross-sectional shape surrounded by two parallel arcs R1 and R2 and two polynomial curves R3 and R4. For each "S"-shaped strut 116, the parallel arc R2 provides a concave outer surface, and the parallel arc R1 provides a concave inner surface. The concave outer surface of the "S"-shaped strut 116 provides as large a surface as possible for contacting the luminal surface of the portal vein PV.

[0035]

[0049] For the "S"-shaped struts 116 that form the diamond-shaped cells 114, the first "S"-shaped strut 116a is joined to the tip and the midpoint of the second "S"-shaped strut 116b at the midpoint and the end, respectively, to form the diamond-shaped cell 114 therebetween. By joining a plurality of such "S"-shaped struts 116 as described above, a plurality of diamond-shaped cells 114 shown with respect to the annular member 112 in FIG. 3 can be obtained. Also in this case, the diamond-shaped cell 114 has a long dimension L 1 and a short dimension L 2 that can vary together. This varies according to the degree to which the "S"-shaped strut 116 is compressed or elongated. For example, a relatively compressed "S"-shaped strut 116 can provide the diamond-shaped cell 114 in FIG. 4, and the long dimension L 1 of the diamond-shaped cell 114 is larger than the short dimension L 2 of the diamond-shaped cell 114.

[0036]

[0050] The distal frame 120 includes, or is formed from, for example, nitinol incorporated struts 122. The distal frame 120 includes a coupling end 124 and an uncoupled end 126 located opposite the coupling end 124, thereby enabling long-term placement of the endoluminal prosthesis 100 within the portal vein PV without migration. The coupling ends 124 of the distal frame 120 are each coupled by incorporation to at least one of the first end annular member 112a or the second end annular member 112b within the incorporation coupling portion 125 at the first end 110a or the second end 110b of the main frame 110, respectively. The incorporation coupling portion 125 is an extension of the incorporated strut 122 into the first end annular member 112a or the second end annular member 112b, thereby providing anti-collapse strength to the endoluminal prosthesis 100 while maintaining the flexibility of the endoluminal prosthesis 100. As shown in FIG. 2A, when a second distal frame 120 is present within the endoluminal prosthesis 100, the second distal frame 120 of the pair of distal frames 120 is coupled by incorporation to the other of the first end annular member 112a or the second end annular member 112b. The second distal frame 120 can be the same as the first distal frame 120, or can be different, for example, with respect to axial length or conicity. In any case, having two distal frames 120 without the tubular graft 130 prevents the endoluminal prosthesis 100 from "covering" the portal vein PV when the endoluminal prosthesis 100 is placed in the portal vein PV.

[0037]

[0051] In the inserted or expanded state of the intraluminal prosthesis 100, the diameter of the unconnected end 126 of the distal frame 120 is larger than the diameter of either the main frame 110 or the connected end 124 of the distal frame 120. The unconnected end 126 of the distal frame 120 can include a plurality of radiopaque keys 128, such as tantalum keys 128, that together cover the braided struts 122 or the fixed ends of the braided struts 122. The plurality of tantalum keys 128 can be an odd number of tantalum keys 128 greater than a collection of, for example, three, five, seven, or nine tantalum keys 128. The width of each tantalum key 128 is greater than the width of any one of the braided struts 122 covered by each tantalum key 128. This facilitates the identification of the tantalum keys 128 by a radiation transmission method such as fluoroscopy. As shown in FIG. 2A, when a second distal frame 120 is present within the intraluminal prosthesis 100, the second distal frame 120 of the pair of distal frames 120 can similarly include the tantalum keys 128, thereby enabling a clinician to improve the positioning of the intraluminal prosthesis 100 by a radiation transmission method.

[0038]

[0052] The tubular graft 130 is located on at least a majority of the main frame 110, below a majority of the main frame 110, or a majority of the main frame 110 is sandwiched between a pair of concentric tubular grafts 130. Any of the embodiments of the tubular graft 130 described above can extend from the first end annular member 112a to the second end annular member 112b, such as up to the apex of the diamond-shaped cell 114, up to the braided connection 125, or beyond the braided connection 125 and up to a portion of the connected end 124 of the distal frame 120.

[0039]

[0053] Any two adjacent annular members 112 are flexibly coupled together only by a flexible coupling 115 provided by a tubular graft 130 between the two adjacent annular members 112, as shown in FIGS. 2A and 2B. However, such adjacent annular members 112 fixedly attached to the tubular graft 130 are physically separate from each other and detached elsewhere. The plurality of flexible couplings 115 between the annular members 112 impart flexibility to the main frame 110 around the annular members 112. The flexible couplings 115 around the annular members 112 enable the endoluminal prosthesis 100 to maintain the same length regardless of whether the endoluminal prosthesis 100 is in the inserted state or the expanded state. The relatively high degree of flexibility accommodates the movement of the surrounding liver tissue with little or no fatigue-based damage to the endoluminal prosthesis 100, permanent deformation of the endoluminal prosthesis 100, or change in the cross-sectional area of the endoluminal prosthesis 100.

[0040]

[0054] The tubular graft 130 can be made of a medically acceptable polymer such as high density polyethylene ("HDPE") or expanded polytetrafluoroethylene ("ePTFE"). Such a tubular graft 130 prevents ingrowth of tissue inside the main frame 110, thereby maintaining the flexibility of the main frame 110.

[0041]

[0055] Referring again to the main frame 110 in view of the above description, the length L of the main frame 110 is given by Equation 1 L = ML 1 +(M - 1)S (Equation 1) where M is the number of annular members 112, L 1 is the longitudinal dimension of the diamond-shaped cell 114, and S is given by Equation 2

[0042]

Number

[0043] as determined by, where L 2 is given by Equation 3 L2 = πD 1 / N (Equation 3) is the short dimension of the diamond-shaped cell 114 determined according to the above formula, where D 1 is the diameter of the main frame 110 in the inserted or expanded state of the endoluminal prosthesis 100, and N is the number of diamond-shaped cells 114 in each annular member 112.

[0044]

[0056] FIG. 6A shows the stress distribution in the annular member of a prior art endoluminal prosthesis, and FIG. 6B shows the stress distribution in the annular member 112 of the endoluminal prosthesis 100 according to some embodiments. As shown, when a radial resistance force is applied to reduce the diameter of each annular member by 1 mm, the prior art annular member experiences a greater stress than the annular member 112 throughout the prior art annular member.

[0045]

[0057] FIG. 7A shows a plot of the von Mises stress in a prior art annular member as a function of displacement, and FIG. 7B shows a plot of the von Mises stress in the annular member 112 according to some embodiments as a function of displacement. As shown, the prior art annular member experiences different stresses at each end of the prior art annular member, and the annular member 112 experiences the same stress at each end of the annular member 112.

[0046]

[0058] FIG. 8A shows the stress distribution and displacement in a prior art annular member subjected to a radial load, and FIG. 8B shows the stress distribution and displacement for the annular member 112 subjected to the same radial load according to some embodiments. In addition, FIG. 9A shows a plot of the state variable p0 for the prior art annular member subjected to the radial load described above as a function of displacement, and FIG. 9B shows a plot of the state variable p0 for the annular member 112 subjected to the radial load described above according to some embodiments as a function of displacement. As shown, the prior art annular member advances by different radial distances at each end of the prior art annular member, and the annular member 112 advances by similar radial distances at each end of the annular member 112.

[0047]

[0059] A method of fabricating a hybrid frame endoluminal prosthesis 100 includes forming a main frame 110 of the hybrid frame by physically attaching a physically separate annular member 112 to a tubular graft 130, knitting a first set of struts 122 into a first end annular member 112a at a first end 110a of the main frame 110 to form a first distal frame 120, knitting a second set of struts 122 into a second end annular member 112b at a second end 110b of the main frame 110 to form a second distal frame 120, thereby forming a pair of distal frames 120 of the hybrid frame as shown in FIGS. 2A and 2B, and securing together the ends of each set of struts 122 with tantalum keys 128, thereby securing the endoluminal prosthesis 100 to be suitable for identification by a radiation transmission method.

[0048]

[0060] This method can further include, when forming the main frame 110, arranging each annular member 112 longitudinally with respect to the previous annular member 112 and then attaching it to the tubular graft 130, thereby ensuring the flexibility of the flexible coupling 115 between the annular members 112 provided by the tubular graft 130.

[0049]

[0061] Securing and attaching the annular member 112 to the tubular graft 130 includes inserting the annular member 112 into the tubular graft 130 and then attaching it to the tubular graft 130, or sandwiching the annular member 112 between this tubular graft 130 and another tubular graft 130 and then attaching it to any of the tubular grafts 130.

[0050]

[0062] Securing together the ends of each set of struts 122 with tantalum keys 128 includes securing together the ends of each set of struts 122 so as to obtain an odd number of tantalum keys 128.

[0051]

[0063] This method can further include securing together any remaining ends of each set of struts 122 without tantalum keys 128 in order to achieve an odd number of tantalum keys 128.

[0052]

[0064] Some specific embodiments have been disclosed herein and have been disclosed to some extent in detail. However, the intention is not that the specific embodiments limit the scope of the concepts provided herein. Additional applicable forms and / or modified forms can also be considered by those skilled in the art, and in a broader aspect, these applicable forms and / or modified forms are similarly included. Therefore, it is possible to depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. An endoluminal prosthesis having an insertion state and an expanded state, comprising: a main frame including a plurality of annular members, each annular member including a plurality of diamond-shaped cells; an end frame including a plurality of woven struts, the end frame including coupling ends coupled to first and second end annular members at the first and second ends, respectively, of the main frame; a tubular graft overlying the main frame, the tubular graft extending only from the first end annular member to the second end annular member; the diamond-shaped cells of the first end annular member and the second end annular member have the plurality of woven struts connected to them by weaving, each woven strut being woven with an adjacent woven strut to form a diamond-shaped cell; An intraluminal prosthesis, wherein a line connecting two opposing vertices along the long dimension of each diamond-shaped cell of the woven strut and a line connecting two opposing vertices along the long dimension of the diamond-shaped cell of the first end annular member or the second end annular member into which each diamond-shaped cell of the woven strut is woven form a straight line.

2. 2. The intraluminal prosthesis of claim 1, An endoluminal prosthesis, wherein the distal frame includes a non-attached end opposite the attached end, the diameter of the non-attached end being greater than the diameter of the main frame in the expanded state of the endoluminal prosthesis.

3. 3. The intraluminal prosthesis of claim 2, An endoluminal prosthesis, wherein the unbonded end includes an odd number of tantalum keys covering the woven struts, the width of the tantalum keys being greater than the width of the woven struts to facilitate identification of the tantalum keys by radiographic methods.

4. An intraluminal prosthesis according to any one of claims 1 to 3, An endoluminal prosthesis wherein any two adjacent annular members are joined together only by the tubular graft over the two adjacent annular members.

5. 5. An endoluminal prosthesis according to claim 4, An endoluminal prosthesis, wherein the tubular graft around any two adjacent annular members enables the endoluminal prosthesis to maintain the same length whether the endoluminal prosthesis is in the insertion state or the expanded state.

6. 6. An intraluminal prosthesis according to claim 4 or 5, An endoluminal prosthesis, wherein the tubular graft provides flexibility to the main frame about any two adjacent annular members.

7. 7. The intraluminal prosthesis of claim 6, An endoluminal prosthesis, wherein the tubular graft prevents tissue ingrowth around the main frame, thereby maintaining the flexibility of the main frame.

8. An intraluminal prosthesis according to any one of claims 1 to 7, An endoluminal prosthesis, wherein the tubular graft is made of high density polyethylene ("HDPE") or expanded polytetrafluoroethylene ("ePTFE").

9. An intraluminal prosthesis according to any one of claims 1 to 8, An endoluminal prosthesis, wherein the main frame and the end frames are both Nitinol.

10. An intraluminal prosthesis, comprising: a main frame including a plurality of physically separate annular members; a pair of end frames including a plurality of woven struts, each end frame including a coupling end coupled to only one of a first end annular member or a second end annular member located at a first end or a second end of the main frame, respectively; a tubular graft overlying the main frame, the tubular graft extending only from the first end annular member to the second end annular member; the diamond-shaped cells of the first end annular member and the second end annular member have the plurality of woven struts connected to them by weaving, each woven strut being woven with an adjacent woven strut to form a diamond-shaped cell; An intraluminal prosthesis, wherein a line connecting two opposing vertices along the long dimension of each diamond-shaped cell of the woven strut and a line connecting two opposing vertices along the long dimension of the diamond-shaped cell of the first end annular member or the second end annular member into which each diamond-shaped cell of the woven strut is woven form a straight line.

11. 11. The intraluminal prosthesis of claim 10, An endoluminal prosthesis, wherein each end frame includes a non-bonded end opposite the bonded end, the non-bonded ends including an odd number of tantalum keys covering the woven struts, the width of the tantalum keys being greater than the width of the woven struts to facilitate identification of the tantalum keys by radiographic methods.

12. 12. An intraluminal prosthesis according to claim 10 or 11, An endoluminal prosthesis wherein any two adjacent annular members are joined together only by the tubular graft over the two adjacent annular members.

13. An endoluminal prosthesis according to any one of claims 10 to 12, An endoluminal prosthesis, wherein the tubular graft is a high density polyethylene ("HDPE") configured to prevent tissue ingrowth around the main frame, thereby maintaining flexibility of the main frame around the annular member.

14. An endoluminal prosthesis according to any one of claims 10 to 13, The length L of the main frame is expressed by Equation 1. L = ML １ +(M-1)S(Equation 1) where M is the number of annular members and L １ is the long dimension of the diamond-shaped cell, and S is the product of Equation 2. [0010] In the above formula, L ２ But, Equation 3 L ２ =πD １ / N (Equation 3) where D is the minor dimension of the diamond-shaped cell determined according to １ is a diameter of the main frame in an inserted or expanded state of the endoluminal prosthesis, and N is a number of diamond-shaped cells in each annular member.

15. A method for an endoluminal prosthesis, comprising: forming a main frame by fixedly attaching a plurality of physically distinct annular members to the tubular graft, each annular member including a plurality of diamond-shaped cells; forming a pair of end frames by the steps of weaving a plurality of struts into a first end annular member at a first end of the main frame to form a first end frame and weaving a plurality of struts into a second end annular member at a second end of the main frame to form a second end frame, wherein the tubular graft extends only from the first end annular member to the second end annular member, the diamond-shaped cells of the first end annular member and the second end annular member have the plurality of woven struts weaved together, each woven strut being woven into adjacent woven struts to form a diamond-shaped cell, and a line connecting two opposing vertices of each diamond-shaped cell along a major dimension of the woven struts forms a straight line with a line connecting two opposing vertices of each diamond-shaped cell along a major dimension of the first end annular member or the second end annular member into which each diamond-shaped cell of the woven struts is woven; and securing the ends of each set of struts together with a tantalum key suitable for their identification by radiography.

16. 16. The method of claim 15, The method further includes the step of: when forming the main frame, positioning each annular member longitudinally relative to the previous annular member before attaching it to the tubular graft, thereby ensuring flexibility of the tubular graft between the annular members provided by the tubular graft.

17. 17. The method of claim 15 or 16, The method, wherein the step of fixedly attaching the annular member to the tubular graft includes the steps of inserting the annular member into the tubular graft and then attaching it to the tubular graft, or sandwiching the annular member between the tubular graft and another tubular graft and then attaching it to either tubular graft.

18. The method according to any one of claims 15 to 17, The method, wherein the step of securing the ends of each set of posts together with the tantalum key includes securing the ends of each set of posts together such that an odd number of tantalum keys is obtained.

19. 20. The method of claim 18, The method further comprising the step of fixing any remaining ends of each set of posts together without said tantalum key to achieve said odd number of tantalum keys.

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