# Patent

## Title
Supra-renal prosthesis and renal artery bypass

## Abstract

The present invention is a system, apparatus, and method for treating, repairing, and/or replacing an aneurysm, preferably an aortic aneurysm, the most preferably, an abdominal aortic aneurysm. The systems, devices, and methods of the present invention include a first prosthesis or stent gasket, and at least one second prosthesis for bypassing the aneurysm, and at least one third prosthesis for establishing a fluid flow channel from the abdominal aorta into another artery, such as a renal artery.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation in part of U.S. application Ser. No. 09/714,093, filed on Nov. 16, 2000; and U.S. application Ser. No. 09/714,079, filed on Nov. 16, 2000 now U.S. Pat. No. 6,482,227.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to devices and methods for repairing aneurysms, and more particularly, to percutaneously and/or intraluminally delivered devices and methods for repairing aneurysms, such as abdominal aortic aneurysms and thoracic aortic aneurysms.
2. Discussion of the Related Art
An aneurysm is an abnormal dilation of a layer or layers of an arterial wall, usually caused by a systemic collagen synthetic or structural defect. An abdominal aortic aneurysm is an aneurysm in the abdominal portion of the aorta, usually located in or near one or both of the two iliac arteries or near the renal arteries. The aneurysm often arises in the infrarenal portion of the diseased aorta, for example, below the kidneys. A thoracic aortic aneurysm is an aneurysm in the thoracic portion of the aorta. When left untreated, the aneurysm may rupture, usually causing rapid fatal hemorrhaging.
Aneurysms may be classified or typed by their position as well as by the number of aneurysms in a cluster. Typically, abdominal aortic aneurysms may be classified into five types. A Type I aneurysm is a single dilation located between the renal arteries and the iliac arteries. Typically, in a Type I aneurysm, the aorta is healthy between the renal arteries and the aneurysm and between the aneurysm and the iliac arteries.
A Type II A aneurysm is a single dilation located between the renal arteries and the iliac arteries. In a Type II A aneurysm, the aorta is healthy between the renal arteries and the aneurysm, but not healthy between the aneurysm and the iliac arteries. In other words, the dilation extends to the aortic bifurcation. A Type II B aneurysm comprises three dilations. One dilation is located between the renal arteries and the iliac arteries. Like a Type II A aneurysm, the aorta is healthy between the aneurysm and the renal arteries, but not healthy between the aneurysm and the iliac arteries. The other two dilations are located in the iliac arteries between the aortic bifurcation and the bifurcations between the external iliacs and the internal iliacs. The iliac arteries are healthy between the iliac bifurcation and the aneurysms. A Type II C aneurysm also comprises three dilations. However, in a Type II C aneurysm, the dilations in the iliac arteries extend to the iliac bifurcation.
A Type III aneurysm is a single dilation located between the renal arteries and the iliac arteries. In a Type III aneurysm, the aorta is not healthy between the renal arteries and the aneurysm. In other words, the dilation extends to the renal arteries.
A ruptured abdominal aortic aneurysm is presently the thirteenth leading cause of death in the United States. The routine management of abdominal aortic aneurysms has been surgical bypass, with the placement of a graft in the involved or dilated segment. Although resection with a synthetic graft via transperitoneal or retroperitoneal procedure has been the standard treatment, it is associated with significant risk. For example, complications include perioperative myocardial ischemia, renal failure, erectile impotence, intestinal ischemia, infection, lower limb ischemia, spinal cord injury with paralysis, aorta-enteric fistula, and death. Surgical treatment of abdominal aortic aneurysms is associated with an overall mortality rate of five percent in asymptomatic patients, sixteen to nineteen percent in symptomatic patients, and is as high as fifty percent in patients with ruptured abdominal aortic aneurysms.
Disadvantages associated with conventional surgery, in addition to the high mortality rate, include an extended recovery period associated with the large surgical incision and the opening of the abdominal cavity, difficulties in suturing the graft to the aorta, the loss of the existing thrombosis to support and reinforce the graft, the unsuitability of the surgery for many patients having abdominal aortic aneurysms, and the problems associated with performing the surgery on an emergency basis after the aneurysm has ruptured. Further, the typical recovery period is from one to two weeks in the hospital and a convalescence period at home from two to three months or more, if complications ensue. Since many patients having abdominal aortic aneurysms have other chronic illnesses, such as heart, lung, liver and/or kidney disease, coupled with the fact that many of these patients are older, they are less than ideal candidates for surgery.
The occurrence of aneurysms is not confined to the abdominal region. While abdominal aortic aneurysms are generally the most common, aneurysms in other regions of the aorta or one of its branches are possible. For example, aneurysms may occur in the thoracic aorta. As is the case with abdominal aortic aneurysms, the widely accepted approach to treating an aneurysm in the thoracic aorta is surgical repair, involving replacing the aneurysmal segment with a prosthetic device. This surgery, as described above, is a major undertaking, with associated high risks and with significant mortality and morbidity.
Over the past five years, there has been a great deal of research directed at developing less invasive, endovascular, i.e. catheter directed, techniques for the treatment of aneurysms, specifically abdominal aortic aneurysms. This has been facilitated by the development of vascular stents, which can and have been used in conjunction with standard or thin-wall graft material in order to create a stent-graft or endograft. The potential advantages of less invasive treatments have included reduced surgical morbidity and mortality along with shorter hospital and intensive care unit stays.
Stent-grafts or endoprostheses are now FDA approved and commercially available. Their delivery procedure typically involves advanced angiographic techniques performed through vascular accesses gained via surgical cutdown of a remote artery, which may include the common femoral or brachial arteries. Over a guidewire, the appropriate size introducer will be placed. The catheter and guidewire are passed through the aneurysm. Through the introducer, the stent-graft will be advanced to the appropriate position. Typical deployment of the stent-graft device requires withdrawal of an outer sheath while maintaining the position of the stent-graft with an inner-stabilizing device. Most stent-grafts are self-expanding; however, an additional angioplasty procedure, e.g., balloon angioplasty, may be required to secure the position of the stentgraft. Following the placement of the stent-graft, standard angiographic views may be obtained.
Due to the large diameter of the above-described devices, typically greater than twenty French (3F=1 mm), arteriotomy closure typically requires open surgical repair. Some procedures may require additional surgical techniques, such as hypogastric artery embolization, vessel ligation, or surgical bypass, in order to adequately treat the aneurysm or to maintain flow to both lower extremities. Likewise, some procedures will require additional, advanced catheter directed techniques, such as angioplasty, stent placement, and embolization, in order to successfully exclude the aneurysm and efficiently manage leaks.
While the above-described endoprostheses represent a significant improvement over conventional surgical techniques, there is a need to improve the endoprostheses, their method of use and their applicability to varied biological conditions. Accordingly, in order to provide a safe and effective alternate means for treating aneurysms, including abdominal aortic aneurysms and thoracic aortic aneurysms, a number of difficulties associated with currently known endoprostheses and their delivery systems must be overcome. One concern with the use of endoprostheses is the prevention of endo-leaks and the disruption of the normal fluid dynamics of the vasculature. Devices using any technology should preferably be simple to position and reposition as necessary, should preferably provide an acute, fluid tight seal, and should preferably be anchored to prevent migration without interfering with normal blood flow in both the aneurysmal vessel as well as branching vessels. In addition, devices using the technology should preferably be able to be anchored, sealed, and maintained in bifurcated vessels, tortuous vessels, highly angulated vessels, partially diseased vessels, calcified vessels, odd shaped vessels, short vessels, and long vessels. in order to accomplish this, the endoprostheses should preferably be extendable and re-configurable while maintaining acute and long term fluid tight seals and anchoring positions.
The endoprostheses should also preferably be able to be delivered percutaneously utilizing catheters, guidewires and other devices which substantially eliminate the need for open surgical intervention. Accordingly, the diameter of the endoprostheses in the catheter is an important factor. This is especially true for aneurysms in the larger vessels, such as the thoracic aorta.
SUMMARY OF THE INVENTION
The suprarenal prosthesis and renal artery by-pass of the present invention provides a means for overcoming the problems associated with anchoring, sealing and/or providing cross-flow into branching arteries, in an artery that is highly angulated, too short for proper positioning or otherwise diseased as briefly described above.
The present invention is directed to a system including at least one prosthesis for repair or replacement of a mammalian body part or condition. The typical system includes a first prosthesis for sealing the system within a predetermined portion of an artery; at least one second prosthesis engaged to the first prosthesis, the second prosthesis providing a fluid flow path through the system or a portion of the system; and a third or extension prosthesis for extending a fluid flow path through the system or a portion of the system. In some embodiments of the invention, the second prosthesis is sealingly and/or matingly engaged with the first prosthesis. In some embodiments of the invention, the extension prosthesis extends the fluid flow path formed by the second prosthesis. In some embodiments of the invention, the extension prosthesis is sealingly and/or matingly engaged with the second prosthesis.
In accordance with the present invention, the predetermined portion, as used herein, refers to a section of artery upstream of an aneurysm, the section being unsuitable for anchoring a prosthesis. In accordance with the present invention, a section is unsuitable if it is non-existent, too short, too bent or angulated, includes another artery (typically, a cross-flow or branch artery), or any other condition in which it would be desirable or beneficial to anchor the prosthesis upstream of the unsuitable section of artery. A section is also unsuitable if it would be deleterious to place a fluid tight prosthesis within a section of artery in which continued blood flow is desirable.
A typical first prosthesis includes a support or stent structure, and a foam or gasket material supported by the stent, the stent and gasket material being configured to seal the system within an artery. A typical first prosthesis may also include one or more structures or elements for engaging the second prosthesis. In preferred embodiments of the invention, these elements or structures sealingly and/or matingly engage the second prosthesis. The stent is typically a synthetic or natural matrix for supporting the gasket material. In some exemplary embodiments of the stent, the stent is a hollow, substantially cylindrical, and preferably radially expandable matrix having a lumen and two open ends. The typical gasket material is a synthetic or natural fabric, tissue, foam, or the like. In preferred embodiments of the invention, the gasket material covers at least a portion of the lumen, even more preferably, the proximal end of the lumen.
The typical second prosthesis of the present invention includes a support or stent structure, and graft material supported by the stent, the stent and graft material defining a fluid flow path therethrough. The typical graft material is a synthetic or natural fabric, tissue, or the like. The stent is typically a synthetic or natural matrix for supporting the graft and/or positioning the prosthesis in a pre-determined position. In some embodiments of the stent, the stent is a hollow, substantially cylindrical, and preferably radially expandable matrix having a lumen and two open ends. The stent typically comprises a plurality of interconnected struts. In some embodiments of the invention, a graft material may be positioned on an inside and/or outside surface of the matrix; in preferred embodiments of the invention, the graft material may include a plurality of substantially longitudinally directed pleats disposed thereon. In a particularly preferred embodiment, the graft further includes a plurality of radially oriented pleat interruptions. In some embodiments of the invention the graft material may be attached to the stent, preferably by one or more staples or the like.
A prosthesis according to the present invention is specifically adapted and configured for an unsuitable section of artery or the like upstream of an aneurysm. These specific adaptations and configurations include, but are not limited to an elongated proximal stent; an elongated proximal stent having a flow through intermediate section, e.g., a section without graft material; a proximal stent portion having a pivot, joint, axis, juncture, hinge, hub or the like to provide an angled prosthesis; and combinations thereof.
A system according to the present invention is intended for repairing or bypassing an aneurysm, preferably an aortic aneurysm. The system may also be used to direct fluid flow from one portion of a fluid pathway to another. The system may also be used for repairing or bypassing aneurysms having an upstream portion unsuitable for anchoring or using a typical prosthesis.
The typical system according to the present invention may include multiple system components, e.g., more than one prosthesis, with the first prosthesis typically positioned upstream of an aneurysm. In preferred embodiments of the invention, the first prosthesis, or BiosealTM stent gasket, includes one or more structures that anchor the system and/or system components in their proper position. The first prosthesis also preferably includes gasket material configured and adapted to facilitate delivery of other system components, to receive and/or position other system components, and/or to seal the system.
For example, a system may include a first prosthesis configured to be positioned in an artery upstream of an aneurysm, and a second prosthesis that matingly engages the first prosthesis and provides a fluid flow path that bypasses the aneurysm. As will be evident from the description below, the system may include a variety of other components all adapted to communicate with another component in the system, with a particular assembly of components designed to establish one or more fluid flow paths that bypass a pre-determined location, e.g., a location that includes an aneurysm and/or an arterial junction.
In preferred embodiments of the present invention, the system includes a first prosthesis suitable for being positioned upstream of an arterial junction, the first prosthesis comprising a gasket material adapted to receive and engage at least one second or bypass prosthesis for bypassing an aneurysm, the gasket material being further adapted to receive and engage at least one third prosthesis for establishing a fluid flow path out of an intermediate portion of the system and into an artery or the like.
For example, the system may include a first prosthesis having a gasket material configured to receive two second prostheses, each second prosthesis configured to bypass an aneurysm; the gasket material being further configured to receive two third prostheses, each third prosthesis being adapted to provide a fluid flow path into an artery.
In the most preferred embodiments of the present invention, the gasket material on the first prosthesis further includes one or more structures configured to assist in delivering one or more other components of the system into position.
A system of the present invention may comprise various components, elements, and/or prostheses, the combination of which preferably provide at least four functions:

    1) an anchor positioned upstream of a cross artery, providing an anchoring function for the system; the typical anchor comprises an uncovered stent portion configured to exert a radial force against the wall of the artery;
    2) a trans- or para-region that spans the cross artery, providing a flexible and open connection between the upstream portion of the system and the downstream portion; the typical trans-region comprises a highly flexible uncovered stent portion or bridge section;
    3) a fluid tight seal, providing a sealing function that prevents fluid leakage outside the system; the typical sealing element or prosthesis is positioned downstream of the cross artery, and includes a sealing diaphragm configured to seat another element or prosthesis that defines a fluid flow path; and
    4) a delivery system guide, providing a guiding function for the various elements of the delivery system; the typical guide is a flared portion of the downstream end of the system, said flared portion providing proper orientation or channeling of the catheter elements used to deliver the various components of the system.


The accompanying figures show illustrative embodiments of the present invention from which these and other of the objectives, novel features and advantages will be readily apparent.



BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other aspects of the present invention will best be appreciated with reference to the detailed description of the present invention in conjunction with the accompanying drawings. Throughout the figures and the description below, like numerals indicate the same element.
FIG. 1 is an elevation view of a fully deployed aortic repair system made in accordance with the present invention.
FIG. 2 is a perspective view of a stent for a first prosthesis, shown for clarity in an expanded state.
FIG. 3 is a perspective view of a first prosthesis having a stent covered by a gasket material.
FIG. 4 is a side elevation of a second prosthesis having a stent covered by a graft material.
FIG. 5 is an elevation view of a fully deployed first prosthesis made in accordance with the present invention and an exemplary delivery system.
FIG. 6 is an end view of the graft material illustrating the graft material in its unexpanded or crimped configuration, and in its fully expanded configuration.
FIG. 7 is a partial, exploded perspective view of the distal end of a second prosthesis of the present invention illustrating an anchoring and delivery system according to the invention.
FIG. 8 is an elevation view of an exemplary embodiment of a fully deployed aortic repair system of the present invention configured with a proximal extension anchor.
FIG. 9 is an elevation view of an exemplary embodiment of a fully deployed aortic repair system of the present invention configured for use in a highly angulated fluid flow path.
FIG. 10 is a side elevation of an exemplary embodiment of a stent of the present invention having a proximal extension anchor.
FIG. 11 is a side elevation of an exemplary embodiment of a stent of the present invention having an angled or jointed proximal extension anchor.
FIGS. 12(a-c) show alternate exemplary embodiments of an angle junction for the stent of FIG. 11.
FIGS. 13(a-h) show a method of delivering and deploying an alternate system according to the invention having a first prosthesis and four bypass prostheses.
FIGS. 14 and 14a show the fully deployed alternate system of FIG. 13.
FIG. 15 is a side cross section of a first prosthesis according to the present invention.
FIGS. 16(a-c) are a top view of alternate embodiments of a cover on a first prosthesis according to the present invention.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The apparatuses, systems, methods, and kits of the present invention may be used in the treatment of aortic aneurysms, preferably an abdominal aortic aneurysm, among other uses noted below. A better understanding of the present device and its use in treating aortic aneurysms will be achieved by reading the following description in conjunction with the above-incorporated references.
The present invention is directed to a prosthesis for repairing or bypassing an aneurysm, the prosthesis comprising a gasket material engaging a stent, the stent comprising at least one proximally extending anchor for positioning and/or anchoring the stent in a portion of an artery upstream of the aneurysm, typically a section of healthy tissue. In preferred embodiments of the invention, the proximally extending anchor is configured into a lattice or matrix of interconnected struts. In the most preferred embodiments of the invention, the lattice or matrix includes diamond shaped structures. A portion of the matrix may or may not include gasket material engaging the matrix.
The present invention is directed to a prosthesis for repairing or bypassing an aneurysm, the prosthesis comprising a gasket material engaging a stent, the stent comprising interconnected struts, wherein the stent includes at least one proximally extending strut for positioning the stent in a portion of an artery upstream of the aneurysm. In some embodiments of the invention, the stent includes five proximally extending struts. In the most preferred embodiments of the invention, the proximally extending struts engage or form a matrix of interconnected struts, preferably interconnected struts formed into one or diamond configurations. A portion of the matrix may or may not include gasket material engaging the matrix.
The present invention is also directed to a prosthesis for repairing or bypassing an aneurysm, the prosthesis comprising a gasket material engaging a stent, the stent comprising a first matrix of interconnected struts configured to engage a proximal section of an artery, and a second matrix of interconnected struts configured to engage a distal section of the artery, the stent including an intermediate portion comprising at least one longitudinally extending strut connecting the first matrix to the second matrix. A portion of the first matrix and/or the second matrix may or may not include gasket material engaging the respective matrix.
An exemplary embodiment of the present invention includes a first prosthesis for repairing or bypassing an aneurysm, the first prosthesis comprising a gasket material engaging a stent, the stent comprising a first matrix of interconnected struts configured to engage a section of an artery upstream of an aneurysm, the gasket material being configured to receive at least one second prosthesis and at least one third prosthesis, the second prosthesis being configured for establishing a fluid flow channel through the aneurysm, the third prosthesis being configured for establishing a fluid flow channel from a proximal portion of the first prosthesis and into a cross artery.
In preferred embodiments of the invention, the gasket material is configured to receive two second prosthesis, each of the second prostheses preferably having a distal end positioned in an artery downstream of the aneurysm (e.g., an iliac artery); and is configured to receive two third prostheses, each of the third prostheses having a distal end positioned in an artery upstream of the aneurysm (e.g., a renal artery).
The present invention also includes a first prosthesis adapted to engage or seat at least one second prosthesis, the first prosthesis comprising a stent; the stent comprising a first portion suitable for engaging a section of a first artery downstream of a junction between a first artery and a second artery; the stent comprising a second portion suitable for engaging an upstream portion of the first artery, the second portion being adapted to engage a section of the first artery upstream of the junction between the first and second arteries; the stent including elongated struts interconnecting the first portion with the second portion.
The present invention may also include a first prosthesis for repairing or bypassing an aneurysm, the first prosthesis comprising a gasket material engaging a stent, the stent comprising a matrix of interconnected struts, the first prosthesis being configured to engage a section of an artery upstream of an aneurysm; wherein a portion of the gasket material is positioned across the fluid flow path, the portion comprising at least one thread or filament defining a predetermined region within the portion, the predetermined region configured to receive at least one second prosthesis, the second prosthesis being configured for establishing a fluid flow channel through the aneurysm. In preferred embodiments of the invention, the portion includes a first filament defining a first predetermined region configured to receive a first second prosthesis, and a second filament defining a second predetermined region configured to receive a second prosthesis.
The present invention also includes an anchor, stent, or prosthesis as described above, wherein an intermediate portion of the anchor, stent, or prosthesis is configured into a flexible bridge, pivot, joint, axis, juncture, hinge, hub or the like.
Any of the prostheses or stents described above may form a component or portion of a system or kit for repairing or bypassing an aneurysm.
The present invention is also a system for repairing and/or replacing an aneurysm, said system being variously configured and/or assembled using components described in more detail below. Typical systems according to this aspect of the invention may include one or more first prostheses or a sealing component, one or more second prostheses or a fluid flow component, and, optionally, one or more component receptacles, assemblies, or connectors for matingly engaging one component with another. Preferred embodiments of a system of the present invention include a sealing component matingly engaged to two fluid flow path components.
Any of the prostheses, stents, systems, or kits described above may be incorporated in a method for treating an aneurysm. In preferred embodiments of the invention, the prostheses, stents, systems, or kits are used to treat an aortic aneurysm, even more preferably, an abdominal aortic aneurysm.
A method of the present invention includes positioning a first portion of a first prosthesis in a first section of an artery, positioning a second portion of the first prosthesis in a second section of the artery, the second section being upstream of an aneurysm, and engaging at least one second prosthesis with the first prosthesis, the second prosthesis forming a fluid flow path that bypasses the aneurysm. In preferred embodiments of the invention, the method includes anchoring the system using the second prosthesis in its expanded configuration. The method may further include anchoring the most upstream portion of the system using the first portion of the stent, matrix, or first prosthesis.
An alternate method of the present invention comprises delivering and deploying a first prosthesis upstream of an aneurysm, the first prosthesis being adapted to receive at least one second prosthesis and at least one third prosthesis; positioning a proximal end of at least one third prosthesis in a proximal end of the first prosthesis, and positioning a distal end of the third prosthesis in an artery upstream of the aneurysm; and positioning a proximal end of at least one second prosthesis in a proximal end of the first prosthesis. In some exemplary embodiments of the invention, the method may further include positioning a distal end of the second prosthesis in an artery downstream of the aneurysm.
Exemplary prostheses and methods of the present invention may be configured to repair an abdominal aortic aneurysm. In these exemplary embodiments of the invention, the first prosthesis may be positioned in an infra-renal or supra-renal portion of the abdominal aorta, the second prosthesis may extend into one of the iliac arteries, and the third prosthesis may extend into one of the renal arteries.
The present invention is also directed to a kit that includes one or more of the following: a sterile or sterilizable enclosure; a first prosthesis; a first prosthesis in an individual sterile enclosure; a second prosthesis; a second prosthesis in an individual sterile enclosure; a third prosthesis; a third prosthesis in an individual sterile enclosure; at least one suture; at least one staple; a collar or catheter tip assembly configured to engage and deliver a first prosthesis, a second prosthesis, and/or a third prosthesis; and at least one marker configured for placement on a first prosthesis, a second prosthesis, a third prosthesis, and/or portions thereof.
The present invention also includes a kit comprising a prosthesis according to the invention, preferably in a sterile or sterilizable enclosure.
A system or kit of the present invention may include one or more modular components. As used herein, a modular component is configured, or adapted to engage, or includes one or more structures that are intended to communicate with or engage a complementary structure on another modular component. The present invention also includes a kit that includes one or more of the following: a sterile or sterilizable enclosure; a first prosthesis; a first prosthesis in an individual sterile enclosure; a second prosthesis; a second prosthesis in an individual sterile enclosure; a third prosthesis; a third prosthesis in an individual sterile enclosure; at least one suture; at least one staple; a collar or catheter tip assembly configured to engage and deliver a first prosthesis, a second prosthesis, and/or a third prosthesis; and at least one marker configured for placement on a first prosthesis, a second prosthesis, a third prosthesis, and/or portions thereof.
Embodiments of the invention may further include one or more second and/or third prostheses configured to matingly engage a first prosthesis, the second and/or third bypass prosthesis comprising a graft material engaging a stent, the stent comprising a hollow matrix comprising a series of interconnected struts, the matrix being moveable from a first dosed position to a second open position; the stent having at least one attachment structure or connector for matingly engaging at least one second complementary structure on the first prosthesis. In some embodiments of the invention, the prosthesis further comprises at least one marker. In preferred embodiments of the invention, the marker or markers are positioned on or formed as part of the stent.
Other embodiments of the present invention will be evident from the description provided below.
Definitions
As used herein, aortic aneurysm refers to any failure of a conduit, such as an aortic wall, typically characterized by an undesirable dilation of a portion of the artery, vessel malformation, or an occlusion. The system and structures of the present invention may be used to treat, repair, replace, or bypass any blood vessel (e.g., artery, vein, capillary); any fluid carrying vessel (e.g., lymphatic vessels); any organ or portion thereof that includes a blood or fluid vessel; or any junction between blood vessels, between fluid vessels, and between organs and blood vessels. An exemplary use of a system and method of the present invention is to repair an aortic aneurysm, and the use of such term is not intended to limit the use of the structures or systems of the present invention to repair or replace other conduit failures. The prosthesis of the present invention may also be utilized in the thoracic aorta, and may be used to repair thoracic aneurysms or dissecting thoracic aneurysms. Accordingly, use of the term “aortic aneurysm”
is intended to relate to and include other aneurysms, including but not limited to both abdominal aortic aneurysms and thoracic aneurysms.
In preferred embodiments of the invention, the system and structures are used to treat, repair, replace, or bypass an abdominal aortic aneurysm.
As used herein fluid pathway refers to any in vivo structure through which a biological fluid passes. A preferred fluid pathway is an artery. Fluid pathways include, but are not limited to channels formed by an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins, and capillaries within an organ or organelle.
As used herein fluid or biological fluid refers to any fluid produced by an animal, including a human. Exemplary biological fluids include but are not limited to blood, oxygenated blood, de-oxygenated blood, gastric fluids, amniotic fluid, spinal fluid, and lymph. The preferred fluid is blood or oxygenated blood.
As used herein, conduit typically refers to any structure used to convey a biological fluid. The conduit may be formed of natural or synthetic materials, or combinations thereof. Exemplary conduits include but are not limited to an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins, capillaries within an organ or organelle, and a prosthesis or system according to the invention.
As used herein, “biofusion” is a word coined by assignee referring to the ability of cells, proteins, fibrin, and other biological molecules to incorporate into the pore structure of a material, such as a foam or gasket material, or a graft material. It is believed that this feature promotes a long term stable biological interface that cannot be separated about six weeks after implantation.
The biofusion effect has many advantages. It has the potential to obviate late endo-leakage by preventing areas of non-organized clot from being displaced or recanalized. It is also believed that biofusion creates a connective tissue collar around the prosthesis that may prevent the aortic neck from dilating over time. Restricting neck dilation avoids leakage pathways and implant migration that can be caused by an insufficient fit with the aorta.
As used herein, adapted for communication, communicating, or similar terms refer to any means, structures, or methods for establishing operational association between two elements of the system. Similarly, engaging, adapted to engage, or similar terms refer to means, structures, or methods for contacting a first component, structure, or portion thereof with a second component, structure, or portion thereof. Exemplary structures are shown in the Figures. Typically, all of these terms and phrases refer to at least one structure in or on a first component configured to engage a complementary structure in or on a second component, and the use of these inter-engaging features to link a first prosthesis or component with a second prosthesis or component. The engagement or communication may be matingly (e.g., permanent) and/or releasably (e.g., temporary). In preferred embodiments of the invention, communication or engagement may be fluid tight, substantially fluid tight, or fluid tight to an extent so as to not substantially compromise the intended function of the structure.
For example, a connector may be adapted to receive or connect to a complementary connector on another prosthesis. As used herein, connector refers to any structure used to form a joint or to join itself to another component or portion thereof. These connectors or connections establish a fluid flow path through various elements of the apparatus, assembly, or system. In a preferred embodiment of the invention, the system is intended to establish at least one fluid flow path through a vessel, conduit, organ, or portions thereof. Typical connections include but are not limited to mating connections, such as Luer-type, screw-type, friction-type, or connectors that are bonded together.
As used herein, distal is used in accordance with its ordinary dictionary definition, e.g., referring to a position farthest from the beginning; in human anatomy, this term is commonly equivalent to caudal or inferior. Proximal is used in accordance with its ordinary dictionary definition, e.g., referring to a position nearest the beginning; in human anatomy, this term is commonly equivalent to cranial or superior. The terms distal and proximal are intended to convey opposite ends or portions of a device, channel, element, or structure. In relation to a fluid flow path, distal will typically refer to a downstream location in the fluid flow path, and proximal will typically refer to an upstream location, unless otherwise specifically noted. Anatomically, distal generally refers to “away from the heart” and proximal generally refers to “toward the heart.”
A system for treating an aortic aneurysm according to the present invention typically includes a first prosthesis or precursor stent and at least one second prosthesis. In preferred embodiments of the invention, the components of the system are delivered intraluminally to the site of the aneurysm using a catheter or the like. One skilled in the art will therefore recognize that it is beneficial to deliver the components of the system in a closed or first position, and to deploy the component in its functional location by expanding the component into an open or second position. A typical second prosthesis forms a fluid flow channel that bypasses the aneurysm. The system may also include at least one third prosthesis, typically forming a fluid flow path into a cross artery upstream of the aneurysm.
Jointed stent, as used herein, refers to any stent structure or configuration that permits one section of the stent to be angled in relation to another section. The angled configuration may be fixed or moveable, flexible or non-flexible, preferably to accommodate the angle of the artery in which the prosthesis is placed. An exemplary embodiment is shown in FIG. 11. Although the angle may be any angle, the preferred stent and first prosthesis of the present invention is capable of achieving an angle of forty-five degrees or more between the two sections. A flexible stent structure, wherein the flexibility is derived from the bridge and/or strut configuration itself, may provide sufficient flexibility and/or articulation to accommodate extreme angulations in an artery's shape. These various flexible stent structures are also included in the meaning of jointed stent.
Each of the components of the system will now be described in more detail. Any references to the Figures will be used to illustrate one or more exemplary embodiments of the invention, without intending to limit the invention thereby.
System
A system according to the present invention may include one or more prostheses. Exemplary systems are shown in FIGS. 1, 8, 9 and 14. The system includes a first prosthesis 10 and at least one second prosthesis, preferably two second prostheses 11a and 11b, which, in combination, bypass an aneurysm 100. In preferred embodiments of the invention, a proximal portion of the system may be positioned in a section 101 of an artery upstream of the aneurysm 100 but below the renal arteries 3, 4, and a distal portion of the system may be positioned in a downstream section of the artery or a different artery. Some embodiments of the system may also include at least one third prosthesis (FIG. 14), preferably two third prostheses 11c and 11d, which may be configured to provide a fluid flow channel into an artery or the like upstream of the aneurysm, e.g., a renal artery 3 or 4.
As shown most dearly in FIGS. 8 and 9, the system of the present invention is intended for use when the section 101 of the artery is unsuitable for anchoring a portion of the system. As noted above, these circumstances exist when the length of section 101 is diseased, too short, includes a junction with a second artery 3 or 4, and/or includes one or more angled sections 104 of artery. Under these and other circumstances, it may be desirable to provide a system, first prosthesis having a proximal portion that extends into an upstream portion 105 of the artery above the renal arteries 3, 4. This proximal portion anchors the system or prosthesis in a section of the artery that is suitable for engaging and anchoring the system or prosthesis.
As shown in FIG. 14, it may also be beneficial to provide a system having one or more third prostheses for channeling fluid flow into a cross or second artery 3 or 4. Under these and other circumstances, it may be desirable to provide a system, first prosthesis positioned across the junction between two or more arteries, e.g., arteries 302, 3 and 4. This proximal portion anchors the system or prosthesis in a section of the artery that is suitable for engaging and anchoring the system or prosthesis, and may be further adapted to receive various other prostheses for bypassing the aneurysm and/or establishing fluid communication with one or more arteries upstream of the aneurysm.
A prosthesis of the present invention includes a support, stent, or lattice of interconnected struts defining an interior space having an open proximal end and an open distal end. The lattice also defines an interior surface and an exterior surface. The interior and/or exterior surfaces of the lattice, or a portion of the lattice, may be covered by or support at least one covering material, such as a foam or gasket material.
In preferred embodiments of the invention, a prosthesis is moveable between an expanded or inflated position and an unexpanded or deflated position, and any position therebetween. An exemplary embodiment of this feature of the invention is shown in FIG. 6 and is intended to generically illustrate a stent or stent graft in its expanded or unexpanded position. In some embodiments of the invention, it may be desirable to provide a prosthesis that moves only from fully collapsed to fully expanded. In other embodiments of the invention, it may be desirable to expand the prosthesis, then collapse or partially collapse the prosthesis. Such capability is beneficial to the surgeon to properly position or re-position the prosthesis. In accordance with the invention, the prosthesis may be self-expanding, or may be expandable using an inflatable device, such as a balloon or the like. Even further in accordance with the present invention, there is provided a delivery apparatus for a self-expanding prosthesis. The apparatus includes an outer sheath, comprising an elongated tubular member having distal and proximal ends, and an inner shaft located coaxially within the outer sheath, the shaft having a distal end and a proximal end. The distal end of the shaft further including at least two grooves disposed thereon. The flanges of the first prosthesis are configured to releasably engage the grooves of a portion of the delivery device.
Exemplary embodiments of a system for treating an abdominal aortic aneurysm according to the present invention are shown in FIGS. 1, 8, 9, and 14. In the exemplary embodiment, illustrated in FIG. 1, the system is deployed in the infrarenal neck 101 of the abdominal aorta, upstream of where the artery splits into right and left common iliac arteries (also known as first and second iliac arteries). FIG. 1 shows stent gasket 10 positioned in the infrarenal neck 101; two second prostheses, 11a and 11b, the proximal ends of which matingly engage a proximal portion of stent gasket 10, and the distal ends of which extend into a common iliac artery 1 or 2. As illustrated, the bodies of second prostheses 11a and 11b form a conduit or fluid flow path that passes through the location of the aneurysm 100. In preferred embodiments of the invention, the components of the system define a fluid flow path that bypasses the section of the artery where the aneurysm is located.
Alternately, FIG. 14 shows stent gasket 10 positioned in the supra-renal portion of abdominal aorta 302. Two second prostheses, 11a and 11b, the proximal ends of which matingly engage a proximal portion of stent gasket 10, and the distal ends of which extend into a common iliac artery 1 or 2, bypass aneurysm 100. Two other prostheses, 11c and 11d, the proximal ends of which also matingly engage a proximal portion of the stent gasket 10, may also be utilized. The distal ends of third prosthesis 11c, lid extend into a renal artery 3 or 4. As illustrated, the bodies of the prostheses 11a and 11b form conduits or fluid flow paths that pass through the location of the aneurysm 100; and the bodies of the prostheses 11c and 11d form conduits or fluid flow paths that pass into an artery upstream of the aneurysm. In preferred embodiments of the invention, the components of the system define one or more fluid flow paths that bypass the section of the artery where the aneurysm is located.
These and other features of the prosthetic devices and systems of the present invention will be described in more detail below.
First Prosthesis or Sealing Prosthesis
The first prosthesis includes a support matrix or stent that supports a sealing material or foam, at least a portion of which is positioned across a biological fluid flow path, e.g., across a blood flow path. In preferred embodiments of the invention, the first prosthesis, including the stent and the sealing material, are radially expandable, and define a hollow space between a proximal portion of the prosthesis and a distal portion of the prosthesis. The first prosthesis may also include one or more structures for positioning and anchoring the prosthesis in the artery, and one or more structures for engaging and fixing at least one second prosthesis in place, e.g., a bypass prosthesis.
The support matrix or stent of the first prosthesis may be formed of a wide variety of materials, may be configured in a wide variety of shapes, and their shapes and uses are well known in the art. Exemplary prior art stents are disclosed in U.S. Pat. No. 4,733,665 (Palmaz); U.S. Pat. No. 4,739,762 (Palmaz); and U.S. Pat. No. 4,776,337 (Palmaz), each of the foregoing patents being incorporated herein by reference.
In preferred embodiments of the invention, the stent of the first prosthesis is a collapsible, flexible, and self-expanding lattice or matrix formed from a metal or metal alloy, such as nitinol or stainless steel. Structures formed from stainless steel may be made self-expanding by configuring the stainless steel in a predetermined manner, for example, by twisting it into a braided configuration. More preferably, the stent is a tubular frame that supports a sealing material. The term tubular, as used herein, refers to any shape having a sidewall or sidewalls defining a hollow space or lumen extending therebetween; the cross-sectional shape may be generally circular, elliptic, oval, rectangular, triangular, or any other shape. Furthermore, the shape may change or be deformable as a consequence of various forces that may press against the prosthesis.
The sealing material or gasket member supported by the stent may be formed of a wide variety of materials, may be configured in a wide variety of shapes, and their shapes and uses are well known in the art. Exemplary materials for use with this aspect of the invention are disclosed in U.S. Pat. No. 4,739,762 (Palmaz) and U.S. Pat. No. 4,776,337 (Palmaz), both incorporated herein by reference.
The sealing material or gasket member may comprise any suitable material. Exemplary materials are composed of a biodurable and biocompatible material, including but are not limited to, open cell foam materials and dosed cell foam materials. Exemplary materials include polyurethane, polyethylene, polytetrafluroethylene; and other various polymer materials, preferably woven or knitted, that provide a flexible structure, such as Dacron®. Highly compressible foams are particularly preferred, preferably to keep the crimped profile low for better delivery. The sealing material or foam is preferably substantially impervious to blood when in a compressed state.
The sealing material may cover one or more surfaces of the stent i.e., can be located along an interior or exterior wall, or both, and preferably extends across the proximal end or a proximal portion of the stent. The sealing material helps impede any blood trying to flow around the first prosthesis, e.g., between the first prosthesis and the arterial wall, and around one or more bypass prostheses after they have been deployed within the lumen of the first prosthesis (described in more detail below).
In preferred embodiments of the invention, the sealing material stretches or covers a portion of the proximal end of the stent and along at least a portion of the outside wall of the stent.
In some embodiments of the invention, it may be desirable for the portion of the sealing material covering the proximal portion of the stent to include one or more holes, apertures, points, slits, sleeves, flaps, weakened spots, guides, or the like for positioning a guidewire, for positioning a system component, such as a second prosthesis, and/or for engaging, preferably matingly engaging, one or more system components, such as a second prosthesis. For example, a sealing material configured as a cover or the like, and having a hole, may partially occlude the stent lumen.
These openings may be variously configured, primarily to conform to its use. These structures promote proper side by side placement of one or more, preferably multiple, prostheses within the first prosthesis, and, in some embodiments of the invention, the sealing material may be configured or adapted to assist in maintaining a certain shape of the fully deployed system or component Further, these openings may exist prior to deployment of the prosthesis, or may be formed in the prosthesis as part of a deployment procedure. The various functions of the openings will be evident from the description below. In preferred embodiments of the invention, the sealing material is a foam cover that has a single hole.
The sealing material may be attached to the stent by any of a variety of connectors, including a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, Dacron® or any other suitable material and attached thereto. Other methods of attaching the sealing material to the stent include adhesives, ultrasonic welding, mechanical interference fit and staples.
One or more markers may be optionally disposed in or on the stent between the proximal end and the distal end. Preferably, two or more markers are sized and/or positioned to identify a location on the prosthesis, or to identify the position of the prosthesis, or a portion thereof, in relation to an anatomical feature or another system component.
First prosthesis is typically deployed in an arterial passageway upstream of an aneurysm, and functions to open and/or expand the artery, to properly position and anchor the various components of the system, and, in combination with other components, seal the system or portions thereof from fluid leaks. For example, the sealing prosthesis may be deployed within the infrarenal neck, between an abdominal aortic aneurysm and the renal arteries of a patient, to assist in repairing an abdominal aortic aneurysm.
FIGS. 1-3 and 10-11 show an exemplary sealing prosthesis 10 of the present invention. Sealing prosthesis 10 includes a cylindrical or oval self-expanding lattice, support, or stent 12 having a substantially circular or oval cross-section, typically made from a plurality of interconnected struts 13. Stent 12 defines an interior space or lumen 18 having two open ends, a proximal end 14 and a distal end 16. One or more markers 15 may be optionally disposed in or on the stent between the proximal end 14 and the distal end 16.
Stent 12 may further include at least two, but preferably eight (as shown in FIG. 2), spaced apart longitudinal legs 20. Preferably, there is a leg extending from each apex 11 of diamonds formed by struts 13. At least one leg, but preferably each leg, includes a flange 28 adjacent its distal end which, as is described in greater detail below, allows for the stent to be retrievable into its delivery apparatus after partial or nearly full deployment of member 12 so that it can be turned, or otherwise repositioned for proper alignment.
FIG. 3 shows the sealing material 30 covering the proximal end of the stent gasket 10. In the embodiment shown in FIG. 3, sealing prosthesis 10 includes a sealing material 30 having a first opening or hole 32 and a second opening or slit 33. The gasket material covers at least a portion of the interior or exterior of the stent, and most preferably covers substantially all of the exterior of the stent. For example, gasket material 30 may be configured to cover stent 12 from the proximal end 14 to the distal end 16, but preferably not covering longitudinal legs 20.
The sealing material helps impede any blood trying to flow around second prostheses 11a and 11b after they have been deployed (as shown in FIG. 1), and from flowing around the stent gasket 10 itself. For this embodiment, sealing material 30 is a compressible member or gasket located along the exterior of the stent 12 and at least a portion of the interior of the stent 12.
Preferred embodiments of the invention are illustrated in FIGS. 15 and 16(a-c). These Figures show a first prosthesis 10 having a gasket material 30 that covers at least a portion of the proximal end of the first prosthesis 10. The gasket material 30 preferably includes a partition that extends approximately across the diameter of the cross section of the first prosthesis 10, wherein the partition includes a thicker gasket material, or further includes a foam or the like. The partition may be formed from any of the gasket or foam materials described above.
The exemplary embodiments illustrated in FIGS. 15 and 16 include a thicker partition 71 in roughly an hourglass shape, although other shapes and sizes may be used. The partition defines at least one section 72 within the prosthesis having less material or the like, these sections being configured for receiving a proximal end of a second prosthesis, as is described in more detail below. In the exemplary embodiments shown in FIGS. 16(a-c), partition 71 defines a first section 72a and a second section 72b; first section 72a is configured to receive a first second prosthesis 11a, and second section 72b is configured to receive a second second prosthesis 11b, as described below.
In accordance with the present invention, it may be desirable to include one or more fibers, threads, filaments, straps, or the like for further defining a section 72. In the description below, the word fiber will be used as a shorthand descriptor for the element that includes fibers, threads, filaments, straps, or the like. In preferred embodiments of the invention, the fiber, etc., assists in positioning a second prosthesis 11a, b. 
In accordance with the present invention, the fiber or thread may be formed from any material and/or comprise any construction suitable for use in a biological environment, e.g., suitable for use in a blood vessel. The fiber or thread may be braided or non-braided, formed of a synthetic or natural material, and/or single or multi-filament Exemplary materials for forming the fiber or thread include but are not limited to polyester, Dacron®, Teflon®, polyurethane, porous polyurethane, silicone, polyethylene terephthlate, and expanded polytetrafluoroethylene (ePTFE). The fiber or thread may also take on other forms. For example, the fiber or thread may be formed from glues or adhesives or by melting sections of the gasket material. In addition, the fiber or thread may comprise struts deformed out of the circumferential plane.
The end or ends of the fiber may be unattached or attached. In a preferred embodiment of the invention, both ends of the fiber are attached or fixed. For example, the ends may be sewn or fixed to the cover 31. In a preferred embodiment of the invention, the ends of the fiber are fixed to a strut 13, even more preferably to a proximal portion of stent 12. One or more ends of the fiber may be fixed to the stent 12 or the strut 13 by threading, knotting, sewing, with adhesives, or any other mechanism for fixing the end of the fiber in place.
In the exemplary embodiments of the invention illustrated in FIGS. 16(a-c), fiber 73 may be variously configured. In FIG. 16a, fibers 73a and 73b may be interwoven in the cover 31, and define or form first section 72a and a second section 72b, as noted above. As shown, the ends of the fibers may be fixed to a strut; see 74a, 74b, 74c, and 74d. In FIG. 16b, a single fiber 73c may be positioned across the diameter of the cover 31, and is fixed to a strut at 74e and 74f. In FIG. 16c, one or more crossed fibers 73d and 73e may be used to form or define partitions 72a and 72b respectively. In the illustrated embodiments, the ends may be attached to the stent 12 at 74a, 74b, 74c, and 74d. 
In some embodiments according to the present invention, it may be desirable to use a fiber that is frangible or breakable. In these exemplary embodiments of the invention, the fiber breaks as the unexpanded prosthesis is expanded to Its fully deployed position. Alternately, the ends of the fibers may be releasably fixed to the stent or strut when the prosthesis is in a collapsed condition, with one or more ends releasing as the prosthesis expands to its fully deployed position.
These structures promote proper side by side placement of one or more, preferably multiple, prostheses within the first prosthesis 10.
FIGS. 10 and 11 show alternative configurations of a stent 12 intended for use with arterial sections unsuitable for use with a typical stent, such as that shown in FIG. 9. The stent configurations shown in FIGS. 10 and 11 include a first portion or matrix 12 configured to engage a downstream portion of an artery 302 (upstream of an aneurysm), and a second portion or matrix 106 configured to engage an upstream portion of the artery 101 (see FIGS. 8 and 9). In arterial networks that are configured the same as or similar to the abdominal aorta network illustrated in FIG. 8, matrix 106 may be configured to engage a portion of the artery 302 upstream of a second artery, such as a renal artery 3 or 4.
In these exemplary embodiments of the invention, the struts 13, of matrix 12 include a proximally extending bridge 107 comprising at least one elongated strut 108 that communicates with or connects to the matrix 106. The exemplary embodiment of the invention shown in FIG. 10 includes a plurality of struts 108, preferably five or eight, that in combination form a straight bridge. The exemplary embodiment of the invention shown in FIG. 11 includes a plurality of struts 108, preferably ten or sixteen, that in combination form a jointed bridge, described in more detail below.
In accordance with the present invention, first matrix 12 and second matrix 106 may comprise similar or the same structures or elements. In some embodiments of the invention, the second matrix 106 may be configured to achieve a greater outwardly directed radial force to anchor the system against or within the artery. In these embodiments of the invention, the first matrix 12 may not need to achieve a similar outwardly directed radial force since this section may receive one or more second prostheses which provide, when expanded or deployed, sufficient outwardly directed radial force to anchor the system in the artery and provide an adequately fluid-tight seal against blood leakage into the aneurysm sac 100.
In accordance with the present invention, the upstream portion, component, or prosthesis of the system may be variously configured to achieve a flexible structure suitable for accommodating one or more highly angled sections of an artery. In preferred embodiments of the invention, the flexibility is achieved without creating kinks in the structure. In addition to the exemplary configurations shown in FIGS. 10-12(a-c), the upstream portion, component, or prosthesis of the system may include open or unattached diamonds or struts, resilient struts, or the like. In preferred embodiments of the invention, the stent or matrix configuration is flexible both longitudinally and radially. As used herein, longitudinal flexibility refers to the ability for a stent or matrix to shorten or elongate as needed.
In the exemplary embodiments of the invention that include a stent configured as those shown in FIGS. 10 and 11, gasket material 30 typically engages only the first portion 12 of the prosthesis 10. Alternately, gasket material 30 may also engage second portion 106 of the prosthesis 10. In the most preferred embodiments of the invention, bridge 107 is open or allows fluid cross flow, as is depicted by the arrows 400 in FIGS. 8-11. In these exemplary embodiments of the invention, gasket material 30 does not engage bridge 107, or the amount of gasket material that engages bridge 107 does not prevent fluid cross flow. In other embodiments of the invention (not shown), gasket material 30 engages or covers bridge 107, but in this embodiment of the invention, the section of gasket material 30 that engages bridge 107 is porous, even more preferably, highly porous. It is intended that these various configurations of the stent and gasket material should not impede or substantially impede the flow of blood through the first prosthesis and into the arteries.
As noted above, the bridge section interposed between the first matrix 12 and the second matrix 106 may be configured to accommodate a bend or highly angulated portion of an artery. In accordance with the present invention, bridge section 107 may be variously configured to allow a prosthesis to have an angled or flexible conformation. One skilled in the art will readily recognize that the need for a prosthesis having an angled conformation may be dependent on a number of factors, including but not limited to, the specific pathological condition of the patient, the flexibility of a given prosthesis, stent, or assembly, and the purpose for which the prosthesis is being used, among others.
One skilled in the art will also recognize that some of the “straight” embodiments described above may be used in pathological conditions that involve or need an angled blood or fluid flow path. For example, a straight prosthesis may be used when only a small angle is involved. Any of the straight exemplary embodiments described above may be deformed to achieve an angled fluid flow path if the amount of deformation does not adversely affect the function of the prosthesis or the well being of the patient
Conversely, one skilled in the art will recognize that a pathological or biological condition having a fluid flow path from a slight deflection to a wide angle (e.g., from about forth-five degrees to about ninety degrees) may warrant the use of a prosthesis having a structural configuration or element that allows the prosthesis to achieve the angled configuration. In these situations, it is believed that the following are exemplary embodiments of the invention that would provide beneficial results in achieving a fluid flow path through a tortuous channel.
A prosthesis having an angled configuration may be achieved by interposing one or more flexible struts, flexible diamonds, open diamonds, pivots, joints, axes, junctions, hinges, narrows, hubs, or the like, in the struts 108 or the bridge 107 between matrix 12 and matrix 106. Individual struts 108 may be joined or connected at this joint, as is shown in FIGS. 11, 12a, 12b and 12c, utilizing various configurations that allow a prosthesis or stent to achieve an angled configuration.
In some embodiments of the invention, an intermediate section of the bridge 107 includes a pivot 120 or hinge. Pivot 120 in FIG. 12c, and similar configurations, allow some degree of movement between the struts of the bridge, i.e., the angle between adjacent struts is moveable or changeable.
The present invention also includes a prosthesis or stent having an intermediate section of the bridge 107 that comprises a joint, junction, or hub 121 in which the struts are fixed together at the intermediate section as illustrated in FIG. 12a. 
The present invention also includes a prosthesis or stent having an intermediate section of the bridge 107 that comprises a narrow or corseted configuration 122 in which a portion of the struts 108 are positioned in close proximity to a portion of another strut. The exemplary embodiment in FIG. 12 B shows an intermediate portion of the struts in close proximity to each other.
As shown in FIGS. 13a-h, gasket material 30 and/or cover 31 may be configured to receive one or more additional system components by including one or more slits, holes, passages, cavities, or the like. Preferably, any structure configured to receive another system component will be deformable or resilient to sealingly engage a portion of the system component. This attribute of the present invention is illustrated by comparing FIG. 13f to FIG. 13h, in which structures 32-35 assume different shapes after the first prosthesis sealing engages multiple system components.
in FIGS. 13e, f, g and h, first prosthesis 10 includes a cover 31 or a gasket having a first opening 32, a second opening 33, a third opening 34, and a fourth opening 35. These openings may be variously configured, primarily to conform to its use. For example, the openings may be a hole, aperture, slit, point, or weakened spot in the cover or no opening at all. Further, these openings may exist prior to deployment of the prosthesis, or may be formed in the prosthesis as part of a deployment procedure. The various functions of the openings are described in more detail below.
An alternate exemplary embodiment of the present invention uses a first prosthesis 10 as described for FIGS. 1 and 3, and positions it across an arterial junction, as shown in FIGS. 14 and 14a. As is readily evident to one skilled in the art, a system that includes a first prosthesis 10 upstream of both an aneurysm and cross arteries will preferably include a number of second and third prostheses for establishing alternate fluid flow paths. In these exemplary embodiments of the invention, first prosthesis 10 preferably includes gasket material 30, cover 31, and/or an occlusive member configured to receive one or more additional system components. In the exemplary embodiment shown in FIGS. 14 and 14a, the system includes two second prostheses, 11a and 11b, and two third prostheses, 11c and 11d. 
Second Prosthesis
The second prosthesis is a bypass conduit or the like that is typically deployed in an arterial passageway upstream of an aneurysm, and establishes a fluid flow path through the system or a portion thereof. In some embodiments of the invention, the second prosthesis defines a fluid flow path that passes through the arterial segment having the aneurysm, e.g., bypassing the aneurysm. In these embodiments of the invention, the second prosthesis extends from a healthy portion of the artery, through the arterial segment having the aneurysm, and into another healthy portion of the artery or another artery. In some embodiments of the invention, the second prosthesis defines a fluid flow path from one portion of the system, e.g., a proximal portion or end, to another portion, e.g., a distal portion or end, or an intermediate portion.
The second prosthesis functions to bypass the portion of the conduit containing the aneurysm, and to properly position and/or anchor the proximal end of the system in an artery. The second prosthesis may also include one or more structures for positioning and anchoring the second prosthesis in the artery or in the first prosthesis. In a preferred embodiment of the invention, the second prosthesis is adapted to engage the first prosthesis.
One or more markers may be optionally disposed in or on the stent between the proximal end and the distal end. Preferably, two or more markers are sized and/or positioned to identify a location on the prosthesis, or to identify the position of the prosthesis, or a portion thereof, in relation to an anatomical feature or another system component. In preferred embodiments of the invention, fluoroscopically identifiable sutures or staples are used; these sutures or staples may also attach the graft material to the stent.
FIGS. 1, 4, 8, 9 show exemplary second or bypass prostheses 11a, b of the present invention. Second prosthesis 11a, b includes a substantially cylindrical self-expanding lattice, support, or stent 40, typically made from a plurality of interconnected struts 44. Lattice 40 defines an interior space having two open ends, a proximal end 41 and a distal end 42. The interior and/or exterior surfaces of lattice 40 may be covered by or support at least one graft material 60.
The second prosthesis typically includes a support matrix or stent that supports a graft material. One end of the second prosthesis is typically adapted to engage one or more portions of first prosthesis. In preferred embodiments of the invention, the proximal end of second prosthesis is adapted to matingly engage a proximal portion of first prosthesis. The second prosthesis may optionally include at least one attachment structure on its distal end for engaging and securing the prosthesis in a portion of an artery downstream of the aneurysm.
These and other features of the second prosthesis will be described in more detail below.
Third Prosthesis
A third prosthesis is a second prosthesis that does not pass through the aneurysm. The third prosthesis is a bypass conduit or the like that is typically deployed in an arterial passageway upstream of an aneurysm, and extends from a healthy portion of a first artery into another healthy portion of the first artery or into a second artery. The third prosthesis functions to establish a fluid flow path or channel from an upstream portion of the system into an artery upstream of the aneurysm, and to properly position and/or anchor a proximal end of the system in an artery. The third prosthesis may also include one or more structures for positioning and anchoring the third prosthesis in the artery or in the first prosthesis. In a preferred embodiment of the invention, the third prosthesis is adapted to engage the first prosthesis.
FIGS. 13a-h, 14 and 14a show exemplary third prostheses 11c and 11d of the present invention. Any third prosthesis may be configured as described above for any second prosthesis.
Stent
Any of the stents of the present invention form a support or lattice structure suitable for supporting a graft material. In preferred embodiments of the invention, the stent defines a channel through which a fluid, such as blood, may flow. A typical stent comprises an expandable lattice or network of interconnected struts. In preferred embodiments of the invention, the lattice is laser cut from an integral tube of material.
In accordance with the present invention, the stent may be variously configured. For example, the stent may be configured with struts or the like that form repeating geometric shapes. One skilled in the art will readily recognize that a stent may be configured or adapted to include certain features and/or to perform a certain function(s), and that alternate designs may be used to promote that feature or function.
In some exemplary embodiments of the invention, the struts of the stent gasket or first prosthesis form a matrix having diamond shapes. In the embodiment of the invention shown in FIG. 2, the matrix or struts of stent gasket 10 is configured into a diamond shapes, preferably having approximately eight diamonds. In a most preferred embodiment of the invention, the fully expanded diamond pattern of a first prosthesis has angles of about forty-five to fifty-five degrees at their distal and proximal ends.
In the exemplary embodiment of the invention shown in FIG. 4, the matrix or struts of stent 40 may be configured into at least two hoops 43, each hoop 43 comprising a number of struts 44 having a diamond shape, having approximately nine diamonds. A second and/or third prosthesis, such as second prosthesis 11a, b, may further include a zigzag shaped ring 50 for connecting adjacent hoops 43 to one another. The zigzag shaped rings 50 may be formed from a number of alternating struts 52, wherein each ring has fifty-four struts.
The diamond pattern for the anchors, as well as the other hoops, provide the hoops with radial and longitudinal stiffness. The longitudinal strength provides for better mechanical fixation of stent 40 to a graft material (described below). The radial strength provides the proximal hoop 45a with better attachment and sealing to the gasket material, and provides the distal hoop 45b with better fixation and sealing to the arterial wall. Further, the distal hoop may be flared, and may be exposed after the graft material has been attached to the stent.
In one preferred embodiment, the proximal and distal hoops 45a, b have greater radial and longitudinal strength than the hoops therebetween. This creates a stent graft having stiff ends for anchoring, but a more flexible body for navigation through the vasculature. The stiffer ends can be accomplished by changing the dimensions of the struts for the end hoops, or by varying the heat treatment of the end hoops during manufacture. The rings allow the stent to bend more easily, and generally provide for more flexibility when the stent is being delivered through a tortuous vessel. When a non-compliant graft is attached to a stent, the strength of the diamond hoops restricts any graft from folding into the blood flow lumen, while maintaining a tight kink radius.
In accordance with some embodiments of the present invention, the proximal and/or distal end of a stent may include one or more anchors and/or one or more struts of the stent configured into an anchor. One or more anchors, commonly referred to as recapture legs, may also be configured to releasably engage a delivery device, such as a catheter, or a portion thereof.
The distal end of the stent is preferably configured to engage a complementary structure on a delivery device, such as a catheter or a portion thereof. For example, the distal end of the stent may include one or more keys that engage, preferably releasably engage, a corresponding latch on the catheter. An exemplary configuration is shown in FIG. 7. It is intended that the invention should not be limited by the precise structures used to engage the stent to the delivery device.
In the exemplary embodiments of the invention shown in the Figures, the stent may include one or more anchors 46 configured to engage a corresponding structure on a delivery device 130 (illustrated most clearly in FIG. 7). In accordance with the present invention, the delivery apparatus may include a collar having one or more grooves 144 or the like adapted to releasably engage one or more complementary structures on a stent or prosthesis of the present invention. For example, the delivery apparatus shown in FIG. 7 includes three grooves 144 to configure the delivery device to releasably engage the second or third prosthesis 11a, b, c, d shown in FIG. 7 (having three anchors 46). The delivery apparatus shown in FIG. 5 includes eight grooves 144 to configure the delivery device to releasably engage the first prosthesis 10. Such an anchor/delivery device configuration is particularly suited to partially deploying a prosthesis of the present invention, and to position or re-position the prosthesis.
Any of the stents of the present invention may be formed of any material suitable for functioning in vivo as a support for graft material. A stent of the present invention may be formed of a wide variety of materials, all of which are well known to those skilled in the art. In some embodiments of the invention, the stent is formed from a metal or metal alloy. In preferred embodiments of the invention, the stent is formed from superelastic Nickel Titanium alloys (Nitinol). Descriptions of medical devices which use such alloys can be found in U.S. Pat. No. 4,665,906 and European Patent Application EP 0928606, both of which are hereby incorporated herein by reference. A stent according to the present invention is preferably laser cut from a tubular piece of nitinol and thereafter treated so as to exhibit shape memory properties at body temperature. In preferred embodiments of the invention, the stent material is expandable or collapsible, i.e., moveable from a first closed position to a second open position, or vice versa.
Graft Material
An inner or outer surface of a stent of the present invention may be covered by or support a graft material. Graft material 60 may be made from any number of materials known to those skilled in the art, including woven polyester, Dacron®, Teflon®, polyurethane, porous polyurethane, silicone, polyethylene terephthlate, expanded polytetrafluoroethylene (EPTFE) and blends of various materials.
In some embodiments of the invention, it may be desirable to incorporate a biodegradable, or degradable material, such as albumin, collagen, or any type of collagen. A graft material that is biodegradable would erode or dissolve over time; however, it is believed that the eroding graft material may be replaced by one or more biofusion constituents, or alternately, a layer of endothelium may grow as the graft material erodes. It is further believed that these new layers of endothelium may provide a new, fluid impervious lining within the aneurysm.
The graft material may be variously configured, preferably to achieve predetermined mechanical properties. For example, the graft material may incorporate a single or multiple weaving and/or pleating patterns, or may be pleated or unpleated. For example, the graft may be configured into a plain weave, a satin weave, include continuous longitudinal pleats, interrupted pleats, annular or helical pleats, radially oriented pleats, or combinations thereof. Alternately, the graft material may be knitted or braided. In the exemplary embodiments of the invention in which the graft material is pleated, the pleats may be continuous or discontinuous. Also, the pleats may be oriented longitudinally, circumferentially, or combinations thereof.
As shown in FIG. 4, graft material 60 may include a plurality of longitudinal pleats 61 extending along its surface, generally parallel to the longitudinal axis of the prosthesis. As shown in FIG. 6, the pleats allow the prosthesis to collapse around its center, much as it would be when it is delivered into a patient. As illustrated, the pleats come together as a series of radially oriented regular folds 68 that pack together efficiently. This provides a relatively low profile delivery system, and provides for a controlled and consistent deployment therefrom. It is believed that this configuration minimizes wrinkling and other geometric irregularities. Upon subsequent expansion, the prosthesis assumes its natural cylindrical shape, and the pleats or folds uniformly and symmetrically open.
In addition, pleats 61 help facilitate stent graft manufacture, in that they indicate the direction parallel to the longitudinal axis, allowing stent to graft attachment along these lines, and thereby inhibiting accidental twisting of the graft relative to the stent after attachment. The force required to push the stent-graft out of the delivery system may also be reduced, in that only the pleated edges of the graft make frictional contact with the inner surface of the delivery system. One further advantage of the pleats is that blood tends to coagulate generally uniformly in the troughs of the pleats, discouraging asymmetric or large clot formation on the graft surface, thereby reducing embolus risk.
As shown in FIGS. 4, and 9, the graft material may also include one or more, and preferably a plurality of, radially oriented pleat interruptions 70. The pleat interruptions are typically substantially circular and are oriented perpendicular to longitudinal axis. Pleat interruptions 70 allow the graft and prosthesis to bend better at selective points. This design provides for a graft material that has good crimpability and improved kink resistance.
As noted above, the extension prosthesis may be pleated longitudinally, axially, or utilizing combinations of both. Under typical conditions, these pleats will form a relatively consistent pattern, e.g., pleats all of a certain length. In the exemplary embodiments of the present invention for use in a highly angulated artery, it may be desirable to vary the pattern or patterns of pleats. For example, in the area of greatest angle, it may be desirable to provide an extension prosthesis having one or two (or more, as needed) pleat interruptions or axially pleated sections separated by a shorter longitudinally pleated section or sections. It is believed that increasing the number of axial pleats in the highly angulated section of the artery improves stent graft kink resistance and decreases the likelihood of localized graft wear from adjacent stent struts.
The graft material as described above is preferably highly compressible, which also promotes a low crimped profile for better delivery characteristics.
In accordance with the present invention, the graft material may be impervious or substantially Impervious to the flow of blood, or may be porous. A graft material is Impervious if it prevents blood from passing through the graft material on contact with blood or after the graft material is saturated with blood. Choice of the flow characteristics of a graft material are well known to those skilled in the art, and are tied in part to the intended function of the prosthesis or portion of the prosthesis. For example, it may be desirable for the material that forms the cover of the first prosthesis to be impervious or substantially impervious to the flow of blood. Alternatively, it may be desirable for a graft material to be porous or partially porous to promote biofusion.
In addition, it is preferable that the gasket member be substantially impervious to the flow of blood, at least when in a partially compressed state. When used throughout the present invention, materials which are substantially impervious to the flow of blood include materials which become substantially impervious to the flow of blood after being saturated with blood.
The foregoing graft materials may be knitted or woven, and may be warp or weft knitted. If the material is knitted, it may be provided with a velour, or towel like surface, which is believed to speed the formation of blood clots, thereby promoting the integration of a prosthesis or prosthesis component into the surrounding cellular structure.
A graft material may be attached to a stent or to another graft material by any number of structures or methods known to those skilled in the art, including adhesives, such as polyurethane glue; a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, Dacron®, or any other suitable material; ultrasonic welding; mechanical interference fit; and staples.
As stated above, a stent preferably has a graft member attached thereto. The graft member covers at least a portion of the interior or exterior of the stent, and most preferably covers substantially all of the exterior of the stent in some embodiments of the invention, prosthesis 11a, b includes graft material 60 that covers only a portion of the distal end 42 of matrix 40. See, for example, FIG. 4.
In an alternate design, graft material may not be utilized on either end of the stent. For example, on any endolegs, prostheses, extension cuffs, stent gaskets or other covered stents, both ends thereof may be left uncovered. The body has the ability to cover the exposed portions of the stent with endothelial cells and thus these exposed portions become endothelialized or incorporated into the vessel wall. This may be an important factor in the long-term stability of the system. Essentially, over long periods of time, the aneurysmal sac can and will shrink if it is totally excluded from blood flow. This shrinkage changes the morphology of the aortic region that has been treated with the bypass prostheses. If all ends of the system are firmly anchored in the actual vessel, as is the case when the ends are covered with endothelium cells, the system will be better able to withstand these morphological changes.
In accordance with the present invention, it may be highly desirable to provide a graft material that limits or substantially eliminates the amount of blood that passes between the graft and the arterial wall, to provide a catheter-delivered graft or prosthesis that extends through a longer portion of an artery, to improve the anchoring mechanisms between two prostheses, to improve the anchoring mechanism between the prosthesis and the arterial wall or an interluminal cavity within an artery, and to improve the fluid dynamic and performance characteristics of the implanted prosthesis.
Marker
As noted above, a stent and/or prosthesis of the present invention may include one or more markers. One skilled in the art will recognize that one or markers may be positioned on the stent, the graft material, or on the prosthesis. In preferred embodiments of the invention, the markers are used to identify the position of the stent or prosthesis in relation to a body part and/or in relation to another stent or prosthesis, and/or to identify the position of one part of the prosthesis relative to another part. In most preferred embodiments of the invention, the marker(s) is used to identify a position in vivo.
As shown in FIGS. 2-4, a stent, such as stents 12 and/or 40, preferably includes one or more radiopaque markers 15. Exemplary materials for forming markers include but are not limited to tantalum, platinum, iridium, and gold. As shown, markers 15 are coils of radiopaque metal, wrapped around the struts of the stent. Markers 15 are preferably made from 0.0075 inch diameter tantalum (Ta) wire wrapped tightly around the struts. The number, location, and size of the marker may vary, and the markers may be used alone or in combination to identify the position of a particular portion of the prosthesis. For example, a proximal marker adjacent aperture 32 may be five mm long and the proximal marker adjacent hole 33 may be two mm long. Also, two distal markers may be one hundred eighty degrees apart, and a proximal marker may be positioned equidistant from each of the distal markers. In this exemplary configuration, the proximal marker then aids proper rotational positioning of the device.
Connectors
Some embodiments of a prosthesis according to the present invention may include one or more connectors. In some embodiments of the invention, the connectors are used to engage or connect one prosthesis or component to another. In some embodiments of the invention, the connectors may be used to attach the gasket material or graft material to a stent or lattice.
As noted above, one skilled in the art will recognize that a variety of materials and methodologies may be used to connect one prosthesis to another, or to attach the graft material to a stent. Exemplary connectors include but are not limited to sutures, staples, rivets, or the like. In preferred embodiments of the invention, the connector is a suture or staple, even more preferably, having a knotted or nub end. Further, a connector may be formed from a radiopaque material or a fluorescent material, each of which allow the connector to be used as a marker.
In accordance with the present invention, it may be desirable to incorporate in a prosthesis a connector adapted for use with a lattice-like stent. A first connector 54, an exemplary embodiment of which is shown in FIG. 4, may be configured for use at an end portion of a stent, preferably at an end portion of a strut 44. A second connector 56, an exemplary embodiment of which is shown in FIG. 7, may be configured for use at an internal portion of a stent, preferably at the junction between two struts 44.
A connector configured for receiving a rivet, staple, suture, or the like, may include two apertures, each aperture configured to receive a leg of the rivet, staple, suture, or the like. In this exemplary embodiment of the invention, the end of each leg is preferably formed into a knot, nub, or spherical end. Preferably, all of the elements noted above are assembled, the legs are passed through the apertures, and the end of each leg is formed into a nub. Alternately, one end may be formed into a nub prior to placement through the aperture, with the second end being formed into a nub after assembly of all the elements.
The number of connectors and staples are typically dictated by the size and structure of a particular stent; it is intended that the invention should not be limited thereby. The illustrated embodiments show six first connectors and three second connectors.
The above staple aperture design or connector assembly has many advantages for attaching gasket material or a graft material to a stent. Because the legs of the staple are folded around and imbedded within a pocket or the like, any risk of puncturing an inflation balloon is minimized. In addition, the structural integrity of the prosthesis is increased because staples more securely attach the graft material to the stent, as compared to prior art designs which use suture or adhesives to attach the graft to the stent.
Staples 90 and 120 (in FIGS. 4 and 7) may be made from any number of materials known in the art, including tantalum alloys, platinum alloys or stainless steel, such as a grade of type 316 stainless steel. The staples may take on other configurations and shapes, and may be coated for lubricity purposes, wear resistance and/or the prevention of corrosion. Essentially, the coating may be used for increased durability. The staples may be formed from a radiopaque material to identify the location of the staple, and to act as a marker to identify the location of a portion of the prosthesis. Using a different number of radiopaque staples on a distal end of a stent as compared to a proximal end further assists in identifying the position of the prosthesis.
Methods
A method in accordance with the present invention includes delivering and positioning a system or component of a system in a fluid conduit, such as an aorta. The components described above permit intraluminal delivery into an aorta. This is accomplished by percutaneously inserting the prostheses into the same or different arteries, e.g., a femoral artery, and navigating them to the site of the aneurysm. This type of procedure is similar to the delivery of angioplasty catheters and guiding catheters into the human vasculature. Upon proper positioning, the system components may be deployed either through a radially, outwardly extending force, e.g., expanding a balloon, or, if a self-expanding stent, by releasing the stent anchors from a constraint. Once fully deployed, at least one passageway is formed bypassing the aneurysm. As shown in FIG. 1, it may be desirable to form two fluid flow paths bypassing the aneurysm, each fluid flow path extending into a separate downstream artery.
In preferred embodiments of the invention, the first prosthesis is a stent gasket, and even more preferably, a stent gasket that expands automatically against the wall of the artery. As the stent gasket expands, proximal longitudinal legs allow the stent gasket diamond rings to expand, thereby anchoring the stent in place. The method also includes delivering and positioning at least one second prosthesis. In preferred embodiments of the invention, the second prosthesis is a bypass conduit for extending through an aneurysm. The second prosthesis is typically positioned within the first prosthesis, preferably into and through a hole in the first prosthesis cover. In most preferred embodiments of the invention, the hole is slightly smaller in diameter than the expanded diameter of the second prosthesis, thus sealingly engaging the second prosthesis in the first prosthesis. The sealed configuration of the second prosthesis within the first prosthesis forms a fluid pathway through the assembly or system, thereby bypassing the aneurysm.
For exemplary embodiments of the invention as illustrated in FIGS. 13 and 14, the method may further include delivering and positioning at least one third prosthesis. In preferred embodiments of the invention, the third prosthesis is a bypass conduit for extending from the proximal end of the system into a cross artery. The third prosthesis is typically positioned within the first prosthesis, preferably into and through a hole in the first prosthesis cover. In most preferred embodiments of the invention, the hole is smaller in diameter than the expanded diameter of the third prosthesis, thus sealingly engaging the third prosthesis in the first prosthesis. The sealed configuration of the third prosthesis within the first prosthesis forms a fluid pathway or channel through a portion of the assembly or system into an artery or position upstream of the aneurysm.
FIGS. 1, 8, 9, 13a-h, 14 and 14a generally show how the system of the present invention may be deployed in vivo. One skilled in the art will readily recognize that a typical delivery device, such as a catheter, includes a guidewire or the like that passes through an aperture in the cover of the first prosthesis, and a collar or the like that releasably engages at least one anchor on the prosthesis. Once the anchors are released from the collar, the first prosthesis can expand, preferably automatically. The portion of the delivery device containing the collar may then be removed from the artery, typically leaving the guidewire in place, i.e., still positioned in an aperture of the first prosthesis cover. The guidewire may then be used to guide another prosthesis or prostheses into position.
In some embodiments of the invention, the collar of the delivery device, engaged to the prosthesis, may be positioned within a sheath or the like until the prosthesis is delivered. In preferred embodiments of the invention, a portion of the prosthesis may be partially deployed and/or positioned. Once it is determined that the prosthesis is in its proper position, the collar can be pushed out of the sheath, thereby releasing the anchors from the collar. If the prosthesis is a self-expanding prosthesis, release of the flanges will allow the prosthesis to deploy automatically. If the prosthesis is not self-expanding, a deflated balloon or the like may be delivered to the interior of the prosthesis using the guidewire. When the balloon is inflated, it will expand the prosthesis into its fully deployed position, i.e., fully expanded radially.
As is evident to one skilled in the art, precisely placing a component(s) of the system may be critical. The physician must have precise placement of the components to ensure adequate repair of the aneurysm. The present invention allows the physician to fully deploy a component within the body without fully releasing the entire component from the delivery device. The anchors releasably interlock with complementary structures, such as grooves, on the delivery device, and, if the physician decides that the placement of the component is incorrect, the outer member of the delivery device may be moved relative to an inner member, thereby resulting in the prosthesis being retrieved or retracted within the delivery device. The extended legs and anchors allow the physician to temporarily position the prosthesis before full deployment. Once the physician is satisfied with a prosthesis position, the legs 20 (FIGS. 13a-h, 14 and 14a) may be released from their engagement with the delivery device.
In order to prevent the physician from prematurely completely deploying a prosthesis, a releasable stop may be preferably placed on the delivery device.
In preferred embodiments of the invention, the system is used to bypass an abdominal aortic aneurysm (AAA). A method for treating or bypassing an AAA includes delivering, preferably percutaneously, a first prosthesis or stent gasket, or one of its components (e.g., the gasket member may be delivered separately, if desired). The components of the system are typically delivered through one of the femoral arteries and deployed within the infrarenal neck, between an abdominal aortic aneurysm and the renal arteries of a patient. In alternate embodiments, the components may be deployed within the suprarenal neck. Once the first prosthesis is properly positioned or repositioned, the legs and anchors are fully released from the delivery device. The delivery device for the precursor stent may then be removed, without removing the guidewire, and another guidewire may be inserted through the other femoral artery and into first prosthesis. If the second guidewire is on the wrong side of the interior of first prosthesis, it will contact the occlusive member and be prevented from easily advancing. The physician may then properly reposition the guidewire through hole 32 (FIGS. 13a-h, 14 and 14a).
Thereafter each delivery apparatus, each containing a sheathed second prosthesis, is inserted into the femoral arteries and maneuvered into the iliac arteries 1 and 2 by sliding them over the guide wires; each of the two second prostheses are then positioned in the first prosthesis. Thereafter, the second prostheses may be either separately or simultaneously deployed.
After proper delivery, first prosthesis 10 and second prostheses 11a, b should appear as they do in FIGS. 1, 8, 9, 14 and 14a. First prosthesis 10 along with its attached gasket material 30 is firmly secured within an arterial section upstream of an aneurysm, and may or may not extend into one or more arteries. For example, the first prosthesis or a portion thereof may be positioned upstream of an arterial junction (FIGS. 8, 9, 14 and 14a) or downstream of the junction (FIG. 1). Second prostheses 11a and 11b provide a fluid flow path that extends through the aneurysm, anchoring in an artery downstream of the aneurysm (FIGS. 1, 8, 9, 14 and 14a). Third prostheses 11c and 11d provide a fluid flow path that extends into cross arteries upstream of the aneurysm, anchoring in a downstream portion of the cross artery (FIGS. 14 and 14a).
In an exemplary embodiment of the invention, a proximal portion of the first prosthesis is positioned upstream of the renal arteries, a distal portion of the first prosthesis is positioned downstream of the renal arteries, for example, in the infrarenal neck region, and an intermediate portion of the first prosthesis is positioned across the junction between the renal arteries and the abdominal aorta. The outward force of the second prostheses 11a, b on the stent gasket or first prosthesis 10 helps to secure the device within the body. The distal ends of the second prosthesis may be firmly attached to the iliac arteries 1 and 2. Thereafter blood will flow from the abdominal aorta 302, through an exemplary system of the present invention comprising a first prosthesis and two second prostheses 11a and 11b, and into iliac arteries 1 and 2, thereby bypassing the aneurysm 100. In this embodiment of the invention, fluid may freely pass through an intermediate portion of the system into renal arteries 3 and 4.
In an alternate exemplary embodiment, the system is further configured with third prostheses 11c and 11d, and fluid is directed through the prostheses into renal arteries 3 and 4.
FIGS. 13a-h are intended to show an exemplary method of delivering, positioning, and deploying a system according to the present invention. In the illustrated embodiment, the system is configured to repair an abdominal aortic aneurysm. In FIGS. 13a and 13b, first prosthesis 10 is positioned in a supra-renal location in the abdominal aorta 302. Longitudinal legs 20 extend through the arterial junction and into an aneurysm 100. The first prosthesis 10 may be properly positioned using guide wires, such as renal guide wires 131a and 131b, that pass through a hole in cover 31. In the illustrated embodiment, the renal wires engage the cover 31 through a knot 133 on the proximal or upstream side of the cover.
in FIG. 13c, renal wires 131a and 131b may be snared using a conventional delivery device, such as catheter 130, and the distal ends of the renal wires may be positioned in the renal arteries 3 and 4. As shown in FIG. 13e, the renal wires may be used to deliver and deploy at least one third prosthesis (as illustrated, 11c and 11d). The proximal end of each third prosthesis matingly engages the proximal end of first prosthesis 10 through holes 34 and 35 respectively. A fluid flow path or channel from the proximal end of the system into a renal artery is thus established.
FIG. 13g illustrates the delivery and deployment of second prostheses 11a and 11b for bypassing the aneurysm. The proximal end of each second prosthesis matingly engages the proximal end of first prosthesis 10 through holes 32 and 33 respectively. A fluid flow path or channel from the proximal end of the system through the aneurysm is thus established.
In accordance with the present invention, a system and method for bypassing an aneurysm may establish one, and possible multiple, fluid flow paths through the system. When the system is placed in an artery upstream of a junction with one or more other arteries, the system permits fluid, such as blood, to flow through the proximal end of the system. and a portion of the blood may flow out of the system into one of the cross arteries. Another portion of the fluid will continue within the system, bypassing the aneurysm and out of the system into one or more downstream arteries. A method of the present invention therefore includes establishing one or more fluid flow paths. in a preferred embodiment of the invention, the method includes establishing a first fluid flow path through the system, wherein the first fluid flow path bypasses the aneurysm. The method may further include establishing at least one second fluid flow path, wherein the second fluid flow path passes through a portion of the system, and passes out of an intermediate portion of the system into an artery or arteries.
It is important to note that even though self-expanding stents are utilized, balloons may be utilized for tacking them into position if necessary.
Although shown and described is what is believed to be the most practical and preferred embodiments, it is apparent that departures from specific designs and methods described and shown will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the invention. The present invention is not restricted to the particular constructions described and illustrated, but should be constructed to cohere with all modifications that may fall within the scope of the appended claims.

## Claims

1. A system for bypassing an aneurysm in an artery comprising:
a first prosthesis having a proximal end, a distal end and a substantially tubular body; 
a gasket covering at least a portion of the proximal end and a portion of the substantially tubular body, said gasket including a plurality of apertures in a portion of the gasket covering the proximal end of the first prosthesis such that the apertures are in line with the substantially tubular body; 
at least one second prosthesis matingly engaged with the proximal end of the first prosthesis through one of the plurality of apertures, said second prosthesis being configured to provide a fluid flow path that extends through the aneurysm; and 
a pair of third prostheses matingly engaged with the proximal end of said first prosthesis through respective ones of the plurality of apertures, each one of said pair of third prostheses being configured to provide a fluid flow path that extends into a cross artery upstream of the aneurysm.

2. The system of claim 1 wherein said pair of third prostheses are configured to be anchored in respective cross arteries.

3. The system of claim 1 wherein each one of the pair of third prostheses is configured to provide a fluid flow path that extends from the proximal end of the first prosthesis into respective renal arteries.

4. The system of claim 1 wherein said first prosthesis is configured to be anchored in the artery upstream from the aneurysm and upstream from the cross arteries.

5. The system of claim 4 wherein the first prosthesis is configured to be anchored in the abdominal aorta upstream from the aneurysm and upstream from the renal arteries.

6. The system of claim 1 wherein said second and third prostheses are expandable.

7. The system of claim 6 wherein a diameter of the one of the plurality of apertures engaged with the at least one second prosthesis is slightly smaller than an expanded diameter of the at least one second prosthesis.

8. The system of claim 6 wherein a diameter of the respective ones of the plurality of apertures engaged with the pair of third prostheses is slightly smaller than an expanded diameter of each of the pair of third prostheses.