Abstract:
An endoluminal prosthesis comprises a tubular member having a proximal opening and a distal opening providing a lumen through which body fluids may flow. The tubular member is constructed of a graft material. The tubular graft is formed of a first material such as a woven fiber or other suitable material for conducting fluid, and sections of a second material configured to extend or contract to permit the tubular graft to flex or straighten to conform to the anatomy in which it is deployed.

Description:
RELATED FIELD  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates to tubular prostheses such as grafts and endoluminal prostheses including, for example, stent-grafts and aneurysm exclusion devices, and methods for placement of such grafts and endoluminal structures. More particularly, the present invention relates to an improved a tubular graft for placement within or in place of a body lumen. The present invention further relates to an endoluminal prosthesis of particular utility in treating vessels with particularly curved or tortuous anatomies.  
         [0003]     2. Background of the Invention  
         [0004]     A wide range of medical treatments have been previously developed using “endoluminal prostheses,” which terms are herein intended to mean medical devices that are adapted for temporary or permanent implantation within a body lumen, including both naturally occurring and artificially made lumens. Examples of lumens in which endoluminal prostheses may be implanted include, without limitation: arteries such as those located within coronary, mesentery, peripheral, or cerebral vasculature; veins; gastrointestinal tract; biliary tract; urethra; trachea; hepatic shunts; and fallopian tubes. Various types of endoluminal prostheses have also been developed, each providing a uniquely beneficial structure to modify the mechanics of the targeted luminal wall.  
         [0005]     A number of vascular devices have been developed for replacing, supplementing or excluding portions of blood vessels. These vascular grafts may include but are not limited to endoluminal vascular prostheses and stent grafts, for example, aneurysm exclusion devices such as those used in the thoracic aortic aneurysm (“TAA”) and abdominal aortic aneurysm (“AAA”) are used to exclude aneurysms and provide a prosthetic lumen for the flow of blood. One very significant use for endoluminal or vascular prostheses is in treating such aneurysms. Vascular aneurysms are the result of abnormal dilation of a blood vessel, usually resulting from disease or a genetic predisposition, which can weaken the arterial wall and allow it to expand. While aneurysms can occur in any blood vessel, most occur in the aorta and particularly the abdominal and thoracic aorta and peripheral arteries.  
         [0006]     Aneurysms have been most commonly treated in open surgery procedures where the diseased vessel segment is bypassed and repaired with an artificial vascular graft. While considered to be an effective surgical technique in view of the alternative of a fatal ruptured abdominal aortic aneurysm, the open surgical technique suffers from a number of disadvantages. The surgical procedure is complex and sometimes requires long hospital stays due to serious complications and has long recovery times and high mortality rates. To reduce the mortality rates, complications and duration of hospital stays, less invasive devices and techniques have been developed. The improved devices include tubular prostheses that provide an artificial lumen or lumens for blood flow while excluding blood flow to the aneurysm site in the native lumen. They are introduced into the blood vessel using a catheter in a less or minimally invasive technique. Although frequently referred to as stent-grafts, these devices differ from covered stents in that they are not used to mechanically prop open natural blood vessels. Rather, they are used to secure an artificial lumen in a sealing engagement with the vessel wall without further opening the natural blood vessel that is already abnormally dilated.  
         [0007]     Typically these endoluminal prostheses or stent grafts are constructed of graft materials such as woven polymer materials (e.g.,—Dacron(polyester), or polytetrafluoroethylene (“PTFE”) and a support structure. The stent-grafts typically have graft material secured onto the inner diameter or outer diameter of the support structure that supports the graft material and/or holds it in place against a luminal wall. The prostheses are typically secured to a vessel wall upstream and downstream of the aneurysm site spanning the aneurysm with at least one attached expandable annular spring member that provides sufficient radial force so that the prosthesis engages the inner lumen wall of the body lumen to seal the prosthetic lumen from the aneurysm. In other devices, other mechanisms have also been used to engage the vessel walls such as, for example, forcibly expandable members or hook like members that puncture the vessel wall.  
         [0008]     When placing a stent graft in a curved or tortuous vessel, the graft material tends to wrinkle or kink where the stent graft bends to conform to the shape of the vessel. Kinking is understood to be a predefined reducing in the flow area of the internal lumen, obstructing the flow lumen and creating a potentially thrombus generating location. Quantitatively, reductions in area on 25% or grater of the total straight tube flow area, can be considered kinked. Kinking is particularly of concern in thoracic applications where the aorta tends to curve as in the aortic arch.  
         [0009]     Accordingly it would be desirable to provide a device structure that avoids such wrinkling and kinking in curved vessels.  
       SUMMARY OF THE INVENTION  
       [0010]     The present invention provides an endoluminal prosthesis having a tubular graft, configured to bend without substantial kinking when deployed in a curved lumen.  
         [0011]     An embodiment of the endoluminal prosthesis according to the invention comprises a tubular member having a proximal opening and a distal opening providing a lumen through which body fluids may flow. The tubular member is constructed of a graft material and typically at least one annular support member. The tubular graft is formed of a first material such as a woven fiber or other suitable material for conducting fluid, and sections of a second material constructed or configured to expand or contract to permit the tubular graft to flex (i.e., curve) or straighten to conform to the anatomy in which it is deployed while not substantially obstructing or impeding the flow of blood as a kink or other bend in a standard stent graft would. In one variation, the sections of elastic material are provided in side locations of the prosthesis that are stretched when the device is straight and that contract or compress when deployed in a curved position to permit bending of the prosthesis while reducing or minimizing the kinking and wrinkling typically found in such endoluminal prostheses.  
         [0012]     In general, the endoluminal prosthesis is radially compressed, and loaded on or otherwise coupled to, the distal end of a catheter for delivery to the deployment site. The deployment/treatment site is located using an imaging technique such as fluoroscopy and is guided through the vasculature with the use of a guide wire to the treatment site. The device has radiopaque markers that indicate the orientation or rotational-angular position of the device when located in the catheter. The device is properly oriented for deployment when the catheter is positioned so that the side having the elastic sections is located adjacent the arcuate side of the vessel having a smaller radius curvature. Once properly located for deployment, any restraining mechanism or protective sheath covering is retracted from the tubular graft. The annular support members and the tubular graft are then released, thus allowing the annular springs to expand, and attach or engage the tubular member to the inner wall of the body lumen. Where the vasculature is curved, the expandable members tend to return to the compressed or contracted position so that the tubular graft tends to curve at those locations. Where the vasculature is straighter, the sections of elastic material are forced by the shape of the vasculature to maintain their shape present in the catheter, i.e., the expandable sections tend to expanded or opened up. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  is a side view of a curved an endoluminal prosthesis according to the invention.  
         [0014]      FIG. 2A  is a side view of the endoluminal prosthesis of  FIG. 1  straightened out.  
         [0015]      FIG. 2B  is a cross-section of the endoluminal prosthesis of  FIG. 2A  along the lines  2 B- 2 B.  
         [0016]      FIG. 3  is a side view of the endoluminal prosthesis of FIGS.  1  deployed across an aortic aneurysm.  
         [0017]      FIG. 4  is a perspective view of the endoluminal prosthesis of  FIG. 3 . 
     
    
     DETAILED DESCRIPTION  
       [0018]     Referring to  FIGS. 1 and 2 A- 2 B, a prosthesis  20  of an embodiment is illustrated in which the graft is constructed to conform the prosthesis to the anatomy of a body lumen in which it is deployed with an expandable section or sections of graft material. The prosthesis  20  comprises a tubular graft  25  and a series of radially compressible annular support members  22  attached to tubular graft  25 . The annular support members  22  support the graft and/or bias the prosthesis  20  into conforming fixed engagement with an interior surface of an aorta  100  (See  FIGS. 3 and 4 ). The annular support members  22  are spring members having a predetermined radii and are constructed of a material such as Nitinol in a superelastic, shape set condition.  
         [0019]     The tubular graft  25  comprises a main tubular portion  26  and a series of expandable graft portions or sections  27   a - c  located on a semi-cylindrical portion  28  (as defined herein a semi-cylindrical portion is not limited to one half of the circular circumference of the tube to be curved—since the graft material on the outside of the curve in which the stent graft is to be placed, does not stretch (at all) a section of flexible material needs to reach to at least half way around the circumference, but more likely ⅔ to ¾ to ⅞ around the circumference—all of which configurations might be termed a semi-cylindrical portion or half or more, but less than all the way around, or less than 90% of the way around.), along a length of the tubular graft  25 . The expandable portions  27   a - c  wrap around or are formed around a semi-cylindrical portion  28  of the tubular prosthesis  20  as illustrated in  FIG. 2B .  
         [0020]     The expandable portions  27   a - c  of the tubular graft  25  are relatively unsupported by annular support members (i.e. they are not directly supported by support members e.g., are not attached to the graft material of the expandable portions) and the sections are relatively flexible (i.e., more flexible than the main tubular portion  26  of the tubular graft). The main tubular portion  26  is formed of a first biocompatible, low-porosity woven fabric, such as a woven polyester or Dacron. Where a Talent™ Stent Graft is used, the principal stent graft material is a thin woven monofilament, which is considered to be relatively stiff and creates indentations or kinks that reduce the area of the flow lumen as a tubular graft of the material is formed into an arch shape. A description of the monofilament material can be found in U.S. Pat. No. 6,344,052 to Greenan et al., incorporated herein by reference. The series of expandable portions  27  are formed of a soft corrugated woven Dacron (e.g. Cooley™ VeriSoft™ material) having corrugated folds  30  oriented in a circumferential pattern that are sewn onto the main portion  26  of the tubular graft  25 . The corrugated folds  30  may be formed by placing the material on a mandrel and winding a wire around the tube of material. (For example, a tube of material may be placed around a mandrel, the folds formed, and then section may be cut to create the expandable portion sections.) Thus, the corrugated material acts like an accordion to expand and contract. The graft materials are thin-walled so that the prosthesis may be compressed into a small diameter, yet are capable of acting as a strong, leak-resistant fluid conduits when expanded to a cylindrical tubular form.  
         [0021]     The expandable portions  27   a - c  when expanded ( FIG. 2A ) have a larger triangular or wedge shaped profile (as viewed from the side as illustrated in  FIG. 2A ). Conversely, when the expandable portions  27   a - c  are compressed, closing the folds, have a smaller triangular or wedge shaped profile (as viewed from the side as illustrated in  FIG. 1 ). When expanded (straightened) as illustrated in  FIG. 2A , the expandable portions  27   a - c  expand to support the side of the semicircular side portion  28  of the tubular graft  25 . The flexibility/foldability of the expandable portions  27   a - c  permit the prosthesis  20  to concentrate the wall compression in those regions and allow the stent graft to bend or curve with reduced kinking, as compared to a uniform graft material wall configuration stent graft, such as the Talent™ Stent Graft. When the expandable portions  27   a - c  are compressed, closing the folds, creating a curve by reducing the length of the prosthesis along the semi-cylindrical portion  28  of the tubular graft  25 .  
         [0022]     In this embodiment, the annular support members  22  are sewn on to the outside of the tubular graft  25  by sutures. Alternative mechanisms of attachment may be used (such as embedding or winding within material, adhesives, staples or other mechanical connectors) and the annular support members  22  may be attached to the inside of the tubular graft  25 . The support members  22  comprise a series of undulating ring members.  
         [0023]     In  FIGS. 3 and 4 , the prosthesis  20  is shown in place in a thoracic aorta  100  excluding or bypassing, a diseased region  105  where the vessel wall is weakened and expanded. The prosthesis  20  is used to relieve blood pressure against the weakened vessel wall, by acting as a fluid conduit through the weakened diseased region  105  or aneurysm. In its deployed configuration, prosthesis  20  defines a conduit for blood flow through the aorta  100 . When deployed, the annular support members  22  are designed to exert a radially outward force sufficient to bias the tubular graft  25  of the endoluminal prosthesis  20  into conforming fixed engagement with the interior surface of aorta  100  upstream and downstream of the diseased region  105 . When deployed, the expandable portions  27   a - c  will permit the tubular graft  25  to bend or flex (contract or extent, or curve or straighten) as is necessary for the graft material to conform to the shape of the vessel and to thereby reduce kinking where the vessel curves.  
         [0024]     As illustrated in  FIGS. 3 and 4 , expandable section  27   a  and  27   b  are compressed to permit the graft  25  to curve at a smaller radius curved portion  107  of the aorta  100  while section  27   c  is extended, i.e., open, permitting the graft  25  to conform to the straight portion  108 . The annular members  22  also act to support the tubular graft  25 , and/or to provide a leak resistant seal between the prosthesis  20  and the inner wall of the aorta  100 .  
         [0025]     To deploy the prosthesis  20 , the prosthesis  20  is loaded into a catheter (not shown) in a straight position wherein the expandable portions  27   a - c  are expanded and annular support members  22  are held in a radially compressed configuration. A thin flexible sheath or cover (not shown) is placed over the prosthesis  20  to restrain the prosthesis and prevent it from damaging or catching on the luminal wall as it is delivered to the aneurysm site. The prosthesis  20  is delivered in a radially compressed state via the catheter through a surgically accessed vasculature, to the desired deployment site. When the distal end of the catheter is located at the deployment site the cover is retracted in a manner as is well understood by persons skilled in the art. The tubular graft  25  further includes radiopaque markers  29  that are sewn into the graft material at predetermined locations with respect to the expandable portions  27   a - c  and the semi-cylindrical portion  28  so that prior to deployment, the prosthesis  20  can be oriented under imaging, so that the semi-cylindrical portion  28  is aligned with the smaller radius curved portion  107  of the vessel. The annular support members  22  expand to bias the prosthesis into conforming fixed engagement with an interior surface of the vessel and engage the vessel wall upstream and downstream of the aneurysm site or diseased portion  105 . The expandable sections  27   a - c  either expand or contract to flexibly conform to the anatomy of the vessel. The expanding and contracting may for example be by folding and unfolding a corrugated section, or by stretching or relaxing the material. Surgical methods and apparatus for accessing the surgical site are generally known in the art and may be used to place the catheter within the vasculature and deliver the prosthesis to the deployment site. Additionally, various actuation mechanisms for retracting sheaths and where desired, inflating balloons of balloon catheters are known in the art. The prosthesis may be delivered to the deployment site by one of several ways. A surgical cut down may be made to access the femoral artery. The catheter is then inserted into the artery and guided to the aneurysm site using fluoroscopic imaging where the device is then deployed. The annular support members supporting the graft, biased in a radially outward direction, are released to expand and engage the prosthesis in the vessel against the vessel wall to provide an artificial lumen for the flow of blood. Another technique includes percutaneously accessing the blood vessel for catheter delivery, i.e., without a surgical cutdown. An example of such a technique is set forth in U.S. Pat. No. 5,713,917, incorporated herein by reference.  
         [0026]     In this embodiment, the graft curves along one side of the length of the graft. However, the graft can be designed to fit other vessels of varying curvatures and twists by placing the expandable sections on a portion of a length of a side of a graft that would match the curvature of a corresponding portion vessel. Furthermore, the expandable sections may be constructed so that their ranges of expansion provide an curved portion for the greater arced side of a length of the graft when expanded, i.e., when contracted the sections provide a curve in one orientation or direction and when substantially expanded, provide a curve in the opposite orientation. (i.e., locating the expandable portion at the greater arced portion of a curved vessel). The device can also be custom made to fit the curvature of a vessel of a particular patient and can also create, e.g., folds that open on varying angles and/or that are positioned at varying locations about the circumference of the graft and along its length.  
         [0027]     While the invention has been described with reference to particular embodiments, it will be understood to one skilled in the art that variations and modifications may be made in form and detail without departing from the spirit and scope of the invention.