Endovascular graft

BACKGROUND THE INVENTION

The This invention relates to a system for the treatment of disorders of the Vascular system. More specifically, a system for treating abdominal aortic aneurysms That is, and the like., A state of expansion and by weakening of the aorta below the diaphragm shows. Such conditions require an engagement due to the serious consequences that often the Death is. earlier A method for the treatment of aortic aneurysms consisted of invasive surgical Method with an arrangement of a graft within the aorta as a reinforcing element of the artery. However, such a procedure requires a surgical incision, to gain access to the vessel, which in turn, can lead to a catastrophic rupture of the aneurysm, namely due to the decreased external pressure from the aorta ... surrounding organs and tissues, which during the procedure to access to win to the vessel moves will. Accordingly, surgical procedures have due the above-discussed possibility tearing additionally to other factors on a high mortality rate. Other factors can include: a poor physical Condition of the patient due to blood loss, anuria, and low Blood pressure associated with the aortic Abdominalaneurysma. An example of a surgical procedure is in a book entitled Surgical Treatment of Aortic Aneurysms described by Denton A. Cooley, MD, which was published in 1986 by the WB Saunders Company.

by virtue of the inherent Risks and complexities of surgical procedures have been various attempts in the Development of alternative methods for use of grafts in Aortic aneurysms undertaken. One such method is the non-invasive method a percutaneous deployment through a catheter-based system. Such a method is described in Lawrence, Jr. et al. In endovascular "Percutaneous graft: experimental evaluation ", Radiology (Mai 1987). Lawrence described therein the use of a Gianturco stents as described in US patent no. 4,580,568 is. The stent is used in the vessel a Dacron fabric graft position. The Darcon graft is compressed within the catheter and then into the to be treated Vessel used. A similar Procedure was continued by Mirich et al. In "Percutaneously Placed endovascular grafts for aortic aneurysms: feasibility study ", Radiology (March 1989) described Mirich. describes therein a self-expanding metallic structure, which is covered by a nylon fabric, the structure of the proximal and anchored at the distal end by peaks.

one the main drawbacks of existing percutaneous devices and The method was that the transplants and for the transfer of Shipments catheters used grafts in profile relative are large, frequently up to 24 French and greater, and are rigid. The great Airfoil and large bending stiffness makes the shipment by the irregular and tortuous arteries difficult of diseased vessels and risky. In particular, the iliac arteries are often too tight or irregularly for the Through a percutaneous device. For this reason, a non-invasive percutaneous graft movement to treat Aortic aneurysms for many Patients who would benefit from it, not available.

A Another contraindication current percutaneous graft methods and apparatus is a vascular treatment site with high neck angulation which a proper fit between the Graft and the vessel wall excludes. On incorrect seating or incorrect seal between the graft and the vessel wall can be Leaks or lead to a range in which the diseased vessel high Burden which is what the to reduced efficacy Graft and a possible Rip the aneurysm leads.

The US-A-5423851 discloses a method and apparatus for mounting an endoluminal device on the walls of tubular structures within the body, which uses an incremental inflate a balloon cuff to to arrange radially projecting spikes which within at the Cuff a plurality of recesses are provided. EP-A-0 646 365 discloses an aortic graft for intraluminal shipment to prepare for an abdominal aortic aneurysm, at least woven wire in the distal or lower end of the graft is, which wire permits the distal end with the aortic bifurcation region matches the aneurysm and with this is sealingly engaged.

While the above process with respect to the treatment of abdominal aortic aneurysms with non-invasive procedure gave hope remains a need after an endovascular graft system which percutaneously in a flexible catheter system used with small diameter can be. additionally there is a need for a graft which contours the an aortic aneurysm more equivalent, which often quite irregularly are and winding and may vary from patient to patient.

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SUMMARY OF INVENTION

According to the present Invention is an endovascular graft provided as claimed in Claim first Preferred features of the invention are defined in dependent claims 2-16 defined. Preferably, the graft can be configured in such a way be that the morphology of a vessel to be treated a Patients equivalent. Alternatively, the inflatable cuff is at both ends the tubular Structure arranged. The inflatable cuffs can in diameter and profile be reduced if the introduction into a vascular system of a patient by a catheter-based system shipments or other appropriate means are emptied. Preferably, the filters inflatable cuff a sufficiently rigid structure ready when they are inflated which supports the graft and the graft against the inner surface the vessel seals, in which it is used. One or more elongated inflatable channels can also be provided on the graft. Preferably, the elongated Channel between and in fluid communication with a proximal and a distal inflatable cuff disposed. The channel provides the Inflate the desired stiffness ready to prevent buckling of the graft frame, and facilitates the use of the graft in a passageway of a body of Patients. The elongate inflatable channel can respect the transplant is a longitudinal or linear configuration include, but is preferably as one around the graft arranged around Wendel designed. Other orientations how interconnecting grids or rings may also for the elongated channels be suitable. The inflatable cuffs and elongated channel contain fluid tight Chambers, which are generally in fluid communication with each other are, however, which is by or frangible may be separated, to control the Aufpumpfolge or use selective / regulate can. The fluid tight chambers are typically accessed by an injection port, which is configured such that a pressurized Source of gas, fluid, particles, gel or a combination thereof receives and which is in fluid connection with at least one fluid-tight chambers is. A fluid which over time sets, cures or gels, can be used. The plurality of elongated channels can with the specific configuration of the graft, depending on Adaptation to a given indication vary, but ranges the number of channels generally from 1 to 25, preferably from 2 to about 8th

On proximal collar portion may at the proximal inflatable cuff be attached. The proximal neck portion has a flexible tubular structure on which similar diameter having the proximal inflatable cuff. The proximal collar portion can be used as a straight tubular may be configured portion or distal or proximal to a increased or reduced diameter be conically shaped. Preferably the proximal collar portion at the proximal inflatable Cuff and secured and sealed proximally to an increased diameter conically shaped so that it in the inner surface of a vessel wall Engages what a sealing effect inflatable in addition to that of the proximal Cuffs provides. Such a configuration smooths the switchover for a fluid flow from the vessel of a Patients to the lumen or channel within the endovascular graft. The proximal neck portion has an inlet axis which preferably a Winkelvorspannung to a longitudinal axis comprising of the graft.

Preferably the graft has a monolithic structure, whereby the Material, which comprises the inflatable cuffs and channels between the elements in a thin flexible layer extends, which longitudinal lumen a defines a flow from blood or other fluid to be limited by this. A Such a monolithic structure can be made of a plurality of suitable polymers including Polyvinyl chloride (PVC), polyurethane, polyethylene and fluoropolymers be formed, such as tetrafluoroethylene (TFE), polytetrafluoroethylene (PTFE) and expanded PTFE (ePTFE). Additional stiffness or reinforcement can the Graft by adding of metal or plastic inserts or framing to the transplant inflicted be, further positioning and insertion of the graft against a inflate an inflatable portion of the graft facilitate.

In a further embodiment , the graft is a thin flexible sheet on which over or between a proximal inflatable cuff, a distal inflatable cuff and an elongated inflatable channel of the frame is arranged. The thin, flexible Layer is made of a material different from the material the cuffs or elongated Channel differs. The barrier is designed such that it a tubular structure forms which longitudinal lumen a or a longitudinal channel define a blood flow to limit therethrough. The flexible barrier may be made a variety of suitable materials are prepared as about DACRON^®. NYLON^®or Fluoropolymers, such as TEFLON^®or like.

On endovascular graft having features of the invention, in a tubular Configuration of a flexible sheet material may be prepared as about DACRON^®. NYLON^®. or fluorine<?page 4?>polymers, as discussed above. The inflatable Cuffs and elongate channels are separately formed and attached to it. The inflatable Cuffs and channels can be also made of the same sheet material, ie DACRON^®. TEFLON^® or NYLON^®. wherein a fluid-tight arranged membrane or bladder within the cuff or channel is to make these fluid-tight. In order to limit the permeability, the material in the regions of the cuffs and channels with a be treated or otherwise coating by methods such as be about thermomechanical compacting processed.

In an alternative embodiment, of the invention is the expansion element at a proximal collar portion the graft attached. Expansion elements may also be attached to the distal end of the graft. Preferably is the expansion element of an expandable ring or connected expandable rings made of a pseudoelastic shape memory alloy prepared, which is self-expanding and a mechanical anchoring the supports the proximal end of the graft to a body channel to to prevent axial displacement of the graft once it is to use. By having an expansion element provided is, which is different from the proximal cuff, the sealing effect the cuff comprising a soft-elastic adaptation to the vessel wall without excessive radial force requires, from the anchoring function of the expansion element be separated, which may require significant radial force. This allows each function is optimized without the function of each harming others. It further allows that the Anchoring function which requires a higher radial force to the vessel wall, proximally is positioned from the aneurysm than the cuff and therefore Healthier disposed portion of the vessel is, which is more suitable for the anchoring function necessary radial strength to persevere. In addition, the cuff and expansion members can spatial in a longitudinal direction be separated, with the graft in a collapsed state for an application is what a lower, more flexible profile for a Percutaneous shipments allowed. Such a configuration allows a collapsed shipment profile 12-16 French, preferably of less than 12 French.

Of the expandable ring or expandable rings of the expansion element can in a continuous loop having a serpentine or zig-zag pattern be formed along a circumference of the loop. Any other similar configuration could are used which allow a radial expansion of the ring would. The expansion element may be made of metals having a suitable high strength be made such as of stainless steel, nitinol, or other shape memory alloys or other composites or polymers with suitable high Strength. The expansion element may be made of materials with a large memory, such as Nitinol, or from materials with low memory, such as stainless steel may be made, depending on the configuration of the endovascular graft, the morphology the place of use and the mode of transportation and the use of Graft.

The Expansion member preferably has an inlet axis which an inlet axis angle with respect to a longitudinal axis the graft forms. The angled inlet axis allows, that the graft better with the morphology of a patient's vascular system coincides in patients having an angular collar aneurysm morphology. The inlet axis angle may range from about 0 to 90 degrees, preferably of about 20 degrees to about 30 degrees. Some or all of the inlet axis angle can in a proximal neck portion of the graft can be achieved, to which the expansion element can be attached. An expansion member or members may be attached as well to the distal end of the graft.

In a further embodiment of the invention, the graft at the distal end of a main body portion be bifurcated graft and at least two bifurcated portions exhibit with Longitudinallumina which contained fluid communication are a Longitudinallumen the main body portion. Of the first bifurcated portion and second bifurcated portion can be made of be formed of a structure which is similar to that of the main body portion, with optional inflatable cuffs at either the proximal or the distal end. One or more elongated channels can between the inflatable Cuffs be arranged.

The Size and angular orientation the bifurcated portions can vary, but they can generally be configured such that it has an outer diameter have, which with the inner diameter of the iliac arteries is a patient compatible. The bifurcated portions can also for use in the renal arteries of a patient or other be designed appropriate indication. The distal ends of the bifurcated sections can also having attached thereto the expansion elements to the distal ends in the just treated body channel to anchor or expand, or both anchor and extend. The expansion members for the distal ends of the forked From<?page 5?>sections can have a structure which is similar to the extension element, the proximal to the end or the proximal portion of the collar Main body portion is attached. The expansion members are preferably made of a shape memory material, such as as nitinol manufactured.

at bifurcated embodiments of grafts having features of the invention, further comprising have a biased proximal end, the inlet axis angle a forms, the direction of the bias of kinking or with respect to a Achieving a proper fit between the graft and the morphology of the deployment site be important. In general, the Winkelvorspannung of the proximal end of the graft, the proximal neck portion or proximal expansion member be in any direction. Preferably, the Winkelvorspannung in a direction normal to a plane defined by a longitudinal axis the main body portion, the first bifurcated portion and second bifurcated portion is defined.

In a further embodiment The invention rupture discs or other temporary closures between fluid-tight chambers of the inflatable cuff and an elongate Channel or channels placing the graft and form a seal between the Chambers. The disks can are cracked or broken if sufficient force or pressure is exerted on a side of a disc or temporary closure. Once the graft at the site to be treated within a body passageway of a patient is arranged, a gas under pressure, Fluid or gel by an inflating catheter into the fluid-tight Chambers of the graft can be injected through an injection port. A injecting a pressurized substance into an inflatable cuff will cause the cuff a generally annular shape assumes, although the cuff conform to the shape of the vessel can, in which it is inserted, and a sufficient radial force outward exercise against the inner wall of the body to be treated passage to the desired provide sealing effect.

Several can rupture disks be arranged at various locations of the graft and can still be configured such that they, or at different pressures Berstgrenzen burst to a deployment of the graft within a body passageway to facilitate. In a particular bifurcated embodiment of the invention, the proximal inflatable cuff of the main body portion proximally of a connection between the branch of the abdominal aorta and the iliac arteries of a patient to be positioned. There the proximal cuff by injecting a suitable substance in an injection port used in fluid communication with the fluid-tight chamber thereof is, it will expand radially and, as well as in the axial direction sealingly fixed proximal to the bifurcation of the aorta. A Rupture disc is between the fluid-tight chamber of the proximal cuff and the elongate inflatable channels such arranged such that the proximal cuff are used primarily can before the rupture disc bursts and the elongated channels is begin to fill with the injected substance. The elongate channels to fill then and are sufficiently rigid and expand, therein a longitudinal lumen to create. When the pressure within the fluid-tight chamber is increased, A rupture disk between the fluid-tight chamber of elongate channels inflatable and a fluid-tight chamber of the optional distal Cuffs or distal manifold of the main body portion of the burst and distal inflatable cuff or manifold will unfold and put under pressure. One of the bifurcated portions of the graft is used when a rupture disk bursts which its fluid-tight Chamber from the distal inflatable cuff or manifold of the main body portion sealing of the graft, if the inflation pressure is increased. After all unfolds the second bifurcated portion of the graft, after a rupture disc bursts which its fluid tight chamber from the main body portion seals.

On Inflating catheter, which transferred to the fluid-tight chambers of the graft a disposed thereon injection port mounted and in fluid communication therewith, may be of the Injection opening after completion of inflation by raising a pressure over a predetermined Level are decoupled. The raised pressure causes a break in a compound with the injection port by triggering a Separation mechanism. Alternatively, the inflating catheter from its Connection to be removed. The injection port, a check valve, include a seal or a plug to the leakage of Aufblasmaterial interrupting once the inflating catheter decoupled has been. The injection port might as well be glued or twisted to seal it.

On Graft having features of the invention may also by a used percutaneous shipments with a catheter-based system are having an inflatable balloon member in Expansion elements of the graft in a compressed state is arranged. The graft is percutaneously desired to Point spent. Once positioned the graft in the axial direction is, the <?page 6?>inflatable member of the balloon to be extended and the extension elements radially against the inner surface of a body channel are acted upon by force, within which it is located. The Expansion elements of a constrained its configuration starting self expandable once the restriction removed is. Once the graft is positioned by the catheter system has been, to the inflatable cuff or cuffs and elongated Channel or channels the graft is pressurized.

These and other advantages of the invention will become apparent from the following detailed Description of preferred embodiments of the invention more apparent are, when used in conjunction with the accompanying exemplary drawings to be viewed as.

SHORT DESCRIPTION THE DRAWINGS

<figref idrefs="S28">1</figref> shows a perspective view of an endovascular graft having features of the invention.

<figref idrefs="S29">2</figref> shows a longitudinal cross-sectional view of a endovascular graft having a monolithic structure.

<figref idrefs="S30">3</figref> shows an enlarged view the longitudinal cross-sectional view the endovascular graft of <figref idrefs="S29">2</figref>,

<figref idrefs="S31">4</figref> shows a longitudinal cross-sectional view of a endovascular graft having features of the invention.

<figref idrefs="S32">5</figref> shows an enlarged view a portion of the in <figref idrefs="S31">4</figref> endovascular graft shown.

<figref idrefs="S33">6</figref> is a perspective view of a bifurcated endovascular graft incorporating features of the present invention.

<figref idrefs="S33">7</figref> is a cross-sectional view in the transverse direction of a bifurcated portion an endovascular graft with 7-7 of <figref idrefs="S33">6</figref>,

<figref idrefs="S34">8A</figref> - <figref idrefs="S34">8C</figref> show perspective views of a bifurcated endovascular graft incorporating features of the present invention in various use levels.

<figref idrefs="S35">9A</figref> is an enlarged longitudinal cross-sectional view of the valve, which could be used to inflate a a maintain fluid tight chamber in the endovascular graft, namely at 9-9 of <figref idrefs="S34">8A</figref>,

<figref idrefs="S35">9B</figref> is an enlarged longitudinal cross-sectional view an alternative seal that could be used to a Aufpumpzustand a fluid tight chamber in the endovascular Graft maintain, namely at 9-9 of <figref idrefs="S34">8A</figref>,

<figref idrefs="S35">9C</figref> is an enlarged longitudinal cross-sectional view an alternative sealing plug, which could be used to a Aufpumpzustand a fluid tight chamber in the endovascular Graft maintain, namely at 9-9 of <figref idrefs="S34">8A</figref>,

<figref idrefs="S35">10</figref> is an enlarged longitudinal cross-sectional view a rupture disc that could be used to Aufpumpsequenz an inflatable endovascular graft to control / regulate, namely at 10-10 of <figref idrefs="S34">8C</figref>,

<figref idrefs="S36">11</figref> is a drawing of an inflation pressure of an inflatable endovascular Graft with respect to time for an endovascular graft having features of the present invention including rupture discs, which are configured such that they at various predetermined To press give in.

DETAILED DESCRIPTION OF THE INVENTION

<figref idrefs="S28">1</figref> shows a perspective view of an endovascular graft <figref>10</figref> With Features of the present invention and having a proximal end <figref>11</figref> and a distal end <figref>12</figref>, The graft is an inflatable frame <figref>13</figref> supported that a proximal end <figref>14</figref> and a distal end <figref>15</figref> having and is shown in its unfolded state. The inflatable Rahmentsruktur<figref>13</figref> has a proximal inflatable cuff <figref>16</figref> at the proximal end <figref>14</figref> and an optional distal inflatable cuff <figref>17</figref> at the distal end <figref>15</figref> on. The inflatable cuff<figref>16</figref> and <figref>17</figref> can in deployed state, an annular have shape, although corresponding to the shape of the vessel Cuffs can, in which they are eingesezt, and can have an outside diameter or a cross-sectional dimension of about 10 to about 45 mm, preferably about 16 to about 28 mm. There is at least one elongate inflatable channel <figref>18</figref> present, positioned between the proximal inflatable cuff <figref>16</figref> and the distal inflatable cuff <figref>17</figref> arranged is. The inflatable frame<figref>13</figref> may have a length of about 5 to about 30 cm, preferably from about 10 to about 20 cm. Between the proximal inflatable cuff<figref>16</figref>, The distal inflatable cuff <figref>17</figref> and the elongated inflatable channel <figref>18</figref> is a thin flexible location <figref>21</figref> arranged, which longitudinal lumen a <figref>22</figref> forms, the fluid flow limit therethrough &lt;?page 7?&gt;can. The thin flexible layer<figref>21</figref> can from the same material as the inflatable cuffs <figref>16</figref> and <figref>17</figref> and the elongated channel <figref>18</figref> can be prepared and integrally with the construction be these elements and form a monolithic structure. The thin flexible location <figref>21</figref> and to form the frame structure <figref>13</figref> used materials can have a wall thickness of about 0.1 to about 0.5 mm, preferably from about 0.15 to about 0.25 mm. The inflatable frame<figref>13</figref> can any from any medical polymer or other material be constructed, including are fluoropolymers, PVCs, polyurethanes, PET, ePTFE and the like. Preferably the inflatable frame <figref>13</figref> and the thin flexible sheet <figref>21</figref> out ePTFE prepared. A proximal collar portion<figref>23</figref> is at the proximal end of the inflatable frame structure <figref>13</figref> appropriate and serves as an additional Means the graft against the inside of a body passageway seal, provides a means for headers n of a proximal end the graft <figref>11</figref> , and provides a tranquil flow transition in the longitudinal lumen <figref>22</figref> ready.

On expansion element <figref>24</figref> having a proximal end <figref>25</figref> and a distal end <figref>26</figref> has the distal end to the proximal end <figref>14</figref> the frame <figref>13</figref> secured. The distal end <figref>26</figref> of the expansion element may also be at the proximal collar section <figref>23</figref> be secured. The expansion element<figref>24</figref> can of expandable rings <figref>27</figref> be made, which in a zig-zag pattern formed by members and <figref>28</figref> are connected. The expansion element<figref>24</figref> is preferably a self-expanding element to release expands from a limited state back to the inner wall of a Body passageway to contact. The expansion element<figref>24</figref> may consist of a any suitable material, which stretch a from a limited condition of allowed, preferably a shape memory alloy, such as Nitinol. The expansion element<figref>24</figref> can such be configured such that it automatically from a limited state from relaxed, or may be configured such that it acts as a Result of pressure exerted from the inside outwardly directed Radial force expands. Other structure of the expansion element<figref>24</figref> suitable Materials include non-stainless steel, MP35N alloy, other Shape memory alloys as Nitinol, fiber composites and the like. The members <figref>28</figref> allow a bend of the expansion element <figref>24</figref>To a curvature of a physique a patient both during the shipments as to go through in situ. The expansion element<figref>24</figref> has a generally cylindrical shape, but may also be directed to the outside protuberances <figref>32</figref> exhibit, which are adapted to the inner surface of a body passageway into engagement to be. The expansion element<figref>24</figref> then instructs, when it is inserted, a generally cylindrical shape, although the expansion element to conform to the shape of the vessel may, in which it is used, and may have a length of having about 0.5 to about 5 cm, preferably about 1 to about 4 cm. The diameter of the expansion element<figref>24</figref> is typically similar to that the inflatable cuff <figref>16</figref> and <figref>17</figref> and may be about 10 to about 35 mm, preferably about 16 to about 28 mm. The high strength material from which the expansion element <figref>24</figref> produced is, a cross-sectional dimension of from about 0.1 to about 1.5 mm weight, preferably from about 0.25 to about 1 mm.

The graft <figref>10</figref> is generally performed by pumping up the inflatable frame structure <figref>13</figref> with a pressurized Material of solid particles, Gas, fluid or gel used, which through an injection orifice <figref>33</figref> be injected can. The pressurized material may contain a contrast agent, which a display of the device during insertion into a body a patient easier. For example stahlenundurchlässige materials such about bismuth, barium, gold, platinum, tantalum or the like., in particle or powder form are used to visualize the graft to facilitate under fluoroscopy. Similarly, to set stahlenundurchlässige marks the same purpose at the graft attached or integrally can be molded into this and from the same stahlenundurchlässigen Materials can be prepared as discussed above.

<figref idrefs="S29">2</figref> shows a longitudinal cross-sectional view of the in <figref idrefs="S28">1</figref> endovascular graft shown. Within the proximal inflatable cuff <figref>16</figref> is a fluid-tight chamber <figref>41</figref>Which is in fluid communication with a fluid-tight chamber <figref>42</figref> the elongate inflatable channel <figref>18</figref> is. The fluid-tight chamber<figref>42</figref> of elongated inflatable channel is in fluid communication with a fluid-tight chamber <figref>43</figref> inflatable within the optional distal Cuffs <figref>17</figref>, A longitudinal axis<figref>44</figref> the graft <figref>10</figref> is additionally to a proximal inlet axis <figref>45</figref> shown that a Inlet axis angle <figref>46</figref> forms with the longitudinal axis. The angled inlet axis <figref>45</figref> is generally created by the proximal collar section <figref>23</figref> and gives the transplant a profile which correspond to the morphology of a patient's vasculature can. The expansion element<figref>24</figref> has a longitudinal axis <figref>47</figref> on, which is generally coextensive with the proximal inlet axis <figref>45</figref> is, However, further can bend to a local Body including a Kragenabwinkelung a erkankten vessel correspond to.

<figref idrefs="S30">3</figref> shows an enlarged view of the &lt;?page 8?&gt;Longitudinal cross-sectional view a portion of the proximal end <figref>11</figref> of in <figref idrefs="S29">2</figref> shown graft <figref>10</figref>, A more detailed view of the fluid-tight chamber<figref>41</figref> of proximal inflatable cuff <figref>16</figref> is also seen as a more detailed View of the attachment of the distal end <figref>26</figref> of the expansion element <figref>24</figref> at the proximal collar portion <figref>23</figref>, The thin flexible layer<figref>21</figref> is between the proximal inflatable cuff <figref>16</figref> and the elongated inflatable channel <figref>18</figref> arranged to see. The expandable rings<figref>27</figref> of expansion element <figref>24</figref> are by members <figref>28</figref> connected, which may be made of the same material as the extension element or of any other suitable material, such as from a biocompatible fiber or a metal such as stainless steel or nitinol.

<figref idrefs="S31">4</figref> is a cross-sectional view of an embodiment of an endovascular graft <figref>51</figref> having features of the invention. The proximal inflatable cuff <figref>52</figref>, The distal inflatable cuff <figref>53</figref> and the elongated inflatable channel <figref>54</figref> are formed by material strips <figref>55</figref> over a tubular structure <figref>56</figref> be sealed to. The Stripes<figref>55</figref> are at the edges <figref>57</figref> connected, therein fluid-tight chambers <figref>58</figref> to build. If the material of the strip <figref>55</figref>Which with the tubular structure <figref>56</figref> connected were, permeable Nature is, an additional Material may be used around the interior of the fluid-tight chambers coat in order for fluids impermeable to make. Alternatively, the material of the strips<figref>55</figref> and the material of these adjacent elongated tubular member <figref>56</figref> made impermeable be, by a further thermal, mechanical or chemical Undergoes processing. Preferably would thermomechanical Compression are used to the fluid-tight chambers <figref>58</figref> for fluids impermeable to make what for an inflating the graft <figref>51</figref> would be suitable.

The proximal end <figref>61</figref> the graft <figref>51</figref> has a proximal collar portion <figref>62</figref> on which inlet axis a <figref>63</figref> Has, the having a longitudinal axis <figref>65</figref> of Graft an inlet axis angle <figref>64</figref> forms. Of the Inlet axis angle <figref>64</figref> allows that the graft <figref>51</figref> one Morphology of vascular channels of Patients corresponds better. Also, an expansion element<figref>66</figref> at the proximal end <figref>61</figref> the graft <figref>51</figref> arranged and is made of expandable rings <figref>67</figref> formed, which by members <figref>68</figref> held together will. The expansion element<figref>66</figref> has a longitudinal axis <figref>71</figref> on, which with the inlet axis <figref>63</figref> the proximal collar portion <figref>62</figref> coincide can. The graft<figref>51</figref> has a thin flexible sheet <figref>72</figref> on, which from the distal end <figref>73</figref> the graft <figref>51</figref> to the proximal end of the graft <figref>61</figref> runs, including the proximal collar portion <figref>62</figref>, The thin flexible layer<figref>72</figref> forms during insertion of the graft a longitudinal lumen or channel <figref>74</figref> which or where a flow of blood or other body fluid limited therethrough.

<figref idrefs="S32">5</figref> is an enlarged view the longitudinal cross-sectional view the endovascular graft of <figref idrefs="S31">4</figref>, A detailed View of the fluid-tight chamber <figref>58</figref> the proximal inflatable Cuffs and elongate inflatable channel can be seen. The edges of the strip<figref>57</figref>, Which the proximal inflatable cuff <figref>52</figref> and the elongate inflatable channel <figref>54</figref> form, are by any Method, such as the use of adhesives, solvents, or warmth, the edges connected. Suitable adhesives would epoxies and cyanoacrylate or the like. include. For use as the thin flexible location <figref>72</figref> or the strip <figref>55</figref> suitable Materials include DACRON^®, TEFLON^® or NYLON^® and also such materials as PVC, polyethylene, polyurethane, and ePTFE.

The <figref idrefs="S33">6</figref> and <figref idrefs="S33">7</figref> show an endovascular graft <figref>81</figref> having features of the invention which a first forked portion <figref>82</figref> and a second forked portion <figref>83</figref> having. A main body portion<figref>84</figref> of graft <figref>81</figref> includes a proximal end <figref>85</figref> and a distal end <figref>86</figref> having a proximal collar portion <figref>87</figref> on, which is disposed at the proximal end, as well as an expansion element <figref>91</figref>. consisting of expandable rings <figref>92</figref> a suitable material may be formed, which have been joined together. At the distal end <figref>86</figref> of main body portion <figref>84</figref> is an optional distal inflatable cuff <figref>93</figref>, which one fluidly connected to a proximal inflatable cuff <figref>94</figref> by an elongated inflatable channel <figref>95</figref> connected is. The distal inflatable Cuff <figref>93</figref> may optionally through a distributor or another suitable structure for a fluid connection between the elongated inflatable channel <figref>95</figref> and the first bifurcated portion <figref>82</figref> or the second bifurcated section <figref>83</figref> be replaced.

Of the first bifurcated portion <figref>82</figref> includes a proximal end <figref>96</figref> and a distal end <figref>97</figref> , wherein an optional distal inflatable cuff <figref>98</figref> is disposed at the distal end. The distal end of the first bifurcated portion <figref>97</figref> can together with or instead of the distal inflatable cuff <figref>98</figref> on have expansion element. The proximal end<figref>96</figref> of first bifurcated portion <figref>82</figref> is at the distal end <figref>86</figref> of Main body portion <figref>84</figref> of graft <figref>81</figref> appropriate. The first bifurcated portion<figref>82</figref> has an optional inflatable elongate channel <figref>101</figref> in which the distal inflatable cuff <figref>98</figref> of first bifurcated portion <figref>82</figref> with the distal to&lt;?page 9?&gt;pumpable Cuff <figref>93</figref> of main body portion <figref>84</figref> fluidly connects. The inflatable elongate channel <figref>101</figref> further provides a support for a first bifurcated portion <figref>82</figref> ready.

Of the second bifurcated portion <figref>83</figref> generally has a Structure to which those of the first section <figref>82</figref> is similar, having a proximal end <figref>102</figref> and a distal end <figref>103</figref>, The distal end <figref>103</figref> has an optional distal inflatable Cuff <figref>104</figref> on. The proximal end<figref>102</figref> the second bifurcated portion <figref>83</figref> is connected to the distal end <figref>86</figref> of Main body portion <figref>84</figref> of graft <figref>81</figref> connected. The distal end of the second bifurcated section <figref>103</figref> can in conjunction with or in place of the distal inflatable cuff <figref>104</figref> an expansion element exhibit. The second bifurcated portion<figref>83</figref> has a optional inflatable elongate channel <figref>105</figref> in which the distal inflatable cuff <figref>104</figref> of second forked portion <figref>83</figref> with the distal inflatable cuff <figref>93</figref> of Main body portion <figref>84</figref> fluidly connects. The inflatable elongate channel <figref>105</figref> further provides a support for the second bifurcated portion <figref>83</figref> ready. The inflatable elongated channel the first bifurcated portion <figref>101</figref> and the inflatable elongated Channel of the second bifurcated portion <figref>105</figref> , as shown, a linear configuration, the main body portion <figref>84</figref> similar having helical configuration or any other suitable configuration. Between the proximal inflatable cuff <figref>94</figref>, The distal inflatable cuff <figref>93</figref> and the elongated inflatable channel <figref>95</figref> of Main body portion <figref>84</figref> the graft <figref>81</figref> is a thin flexible location <figref>106</figref> present which longitudinal lumen a <figref>107</figref> forms, the flow of blood or other body fluid to limit therethrough. Between the distal inflatable Cuff <figref>98</figref> and the elongate inflatable channel <figref>101</figref> the first bifurcated portion <figref>82</figref> and the distal inflatable cuff <figref>93</figref> of main body portion <figref>84</figref> is a first thin flexible location <figref>108</figref> present which longitudinal lumen a <figref>109</figref> forms, which is in fluid communication with the longitudinal lumen <figref>107</figref> of main body portion <figref>84</figref> is. The second bifurcated portion may also formed separately from a main body portion his and after percutaneous shipment thereof by docking method with the main body portion get connected. The first and second forked portion<figref>82</figref> and <figref>83</figref> then have, when they are used, in general a cylindrical shape on, although they may form the corresponding one vessel in which they are used, and can a length comprise from about 1 to about 10 cm. The outer diameter of the distal ends the first and the second bifurcated portion <figref>82</figref> and <figref>83</figref> can of about 2 to about 30 mm range, preferably from about 5 to about 20 mm.

A second thin flexible location <figref>111</figref> is inflatable between the distal Cuff <figref>104</figref> and the elongate inflatable channel <figref>105</figref> the second bifurcated portion <figref>83</figref> and the distal inflatable cuff <figref>93</figref> of main body portion <figref>84</figref> arranged. The second thin flexible storage <figref>111</figref> forms a longitudinal lumen <figref>112</figref>which in fluid communication with the longitudinal lumen <figref>107</figref> of main body portion <figref>84</figref> is. The thin flexible sheet of the first bifurcated portion surrounds the elongated Lumen of the first bifurcated portion. The thin flexible layer of the second bifurcated portion surrounds the elongated lumen of the second bifurcated Section. <figref idrefs="S34">8A</figref> - <figref idrefs="S34">8C</figref> show an endovascular graft <figref>121</figref> with certain characteristics However, the invention (showing no expansion element <figref>24</figref>) in various stages of deployment for the purposes of clarity of Explanation. In <figref idrefs="S34">8A</figref> is a Aufpumpkatheter <figref>122</figref> with a Injection opening <figref>123</figref> in a first forked portion <figref>124</figref> the endovascular graft <figref>121</figref> connected. The injection port <figref>123</figref> is having a distal inflatable cuff <figref>125</figref> the first bifurcated section <figref>124</figref> connected and is in fluid communication with a fluid-tight chamber <figref>126</figref> therein. The first bifurcated portion<figref>124</figref> and a main body portion <figref>127</figref> were in <figref idrefs="S34">8A</figref> inflated in any significant way. However, it was prevents a second bifurcated portion <figref>128</figref> unfolded namely by bursting discs <figref>131</figref>Which in fluid-tight chambers <figref>132</figref> the elongate inflatable channels <figref>133</figref> of Main body portion <figref>127</figref> arranged were associated with fluid-tight chambers <figref>134</figref> elongated inflatable channels <figref>135</figref> of second bifurcated portion <figref>128</figref> are connected. In<figref idrefs="S34">8B</figref> has been the second bifurcated portion <figref>128</figref> mainly used, and While on a break-up or breaking the rupture disks <figref>131</figref> below, which in the fluid-tight chambers <figref>132</figref> and <figref>134</figref> of the elongated inflatable channels <figref>133</figref> and <figref>135</figref> arranged are what the flow a pressurized substance permitted therein. <figref idrefs="S34">8C</figref> shows the endovascular graft fully deployed and illustrates loosening a distal end <figref>136</figref> the Aufpumpkatheters <figref>122</figref> from the injection port <figref>123</figref>what by increasing the pressure is performed in the Aufpumpkatheter until a separation mechanism <figref>137</figref> is triggered.

<figref idrefs="S35">9A</figref> shows a longitudinal cross-sectional view at 9-9 of <figref idrefs="S34">8A</figref>, The unidirectional inflation valve<figref>141</figref> has an external wall <figref>142</figref>. an inner lumen <figref>143</figref>, An annular spring stop <figref>144</figref>a annular ball seat <figref>145</figref>, A seal body <figref>146</figref> and a seal spring <figref>147</figref> on. In the<figref idrefs="S35">9A</figref> shown Configuration allows the possibility of an inflation medium in the Direction of the arrow <figref>148</figref>While a leakage thereof is prevented as soon as the pressure is released.

&lt;?page 10?&gt;

<figref idrefs="S35">9B</figref> shows an alternative unidirectional valve. The unidirectional inflation valve<figref>149</figref> has an external wall <figref>149A</figref>. an inner lumen <figref>149B</figref>A first reed valve <figref>149C</figref> and a second reed valve <figref>149D</figref> in which in a relaxed state is fluidly sealed with the first reed valve. In the<figref idrefs="S35">9B</figref> shown Konfiguraiton allows the possibility of an inflation medium in the direction arrow <figref>149E</figref>, while leakage thereof is prevented when the pressure subsided becomes.

<figref idrefs="S35">9C</figref> shows an alternative seal <figref>150</figref>, The seal has a outer wall <figref>150A</figref>. an inner lumen <figref>150B</figref>, A plug <figref>150C</figref> and a sealing surface <figref>150D</figref> on. The plug <figref>150C</figref> has a sealing head <figref>150E</figref>, which one by irreversible deployment by application of force to the plug in the direction of arrow <figref>150E</figref> sealingly with the sealing surface <figref>150D</figref> in Engaged.

<figref idrefs="S35">10</figref> shows a longitudinal cross-sectional view of a rupture disc <figref>151</figref> 10-10 of <figref idrefs="S34">8C</figref>, The rupture disc<figref>151</figref> has a wall element <figref>152</figref> on which a sealing manner against the inner surface <figref>153</figref> one fluid-tight chamber <figref>154</figref> is secured. The wall element<figref>152</figref> is configured such that it will fail under pressure, before the Failure of the surrounding wall <figref>155</figref> the fluid-tight chamber <figref>154</figref> among Pressure. The rupture disc<figref>151</figref> allows use shipment and inflating other fluid-tight chambers as that which were sealed by the rupture disc. Once sufficient force or pressure against the wall <figref>152</figref> the rupture disc is applied, a failure to cause the rupture disk <figref>151</figref> break and the occurrence of an inflation medium and deployment of a portion an inflatable graft permit, by which previously the rupture disk was sealed.

<figref idrefs="S36">11</figref> shows a graphical representation of inflation pressure <figref>161</figref> about the time <figref>162</figref> at an injection opening of an inflatable graft as it in <figref idrefs="S34">8A</figref> - <figref idrefs="S34">8C</figref> illustrated is, during the process of inserting. P₁ represents the inflation pressure at the injection port prior to the rupturing of any Rupture discs in the endovascular graft. P₂ represents the pressure which is required to failure or bursting the weakest Rupture disc in the endovascular graft to effect, by which a previously by the weakest Bursting disc sealed portion of the endovascular graft is inflated and deployed. The pressure then increases over the Time to P₃ to which the pressure level is required to failure or bursting of a second to cause the rupture disk. P₄ is the pressure level, which for triggering an Separation mechanism at the distal end of Aufpumpkatheters required is.