Apparatus and method for deploying an implantable device within the body

STENT LOADED CATHETER SETS

FIELD OF INVENTION

The present invention relates to the treatment of vascular diseases, including, for example, aneurysms, ruptures, pseudoaneurysms, dissections, vulnerable plaque exclusions and treatment of occlusive diseases, and more particularly to an apparatus a method for applying and distributing an implantable device within the body to treat more conditions.

The present invention is particularly suited for the implantation of stents, grafts and stent grafts into arteries or other vessels at sites involving two or more intersecting vessels.

BACKGROUND OF THE INVENTION

In the prior art, treatment of cardiovascular disease with implantable graft stents is well known.

For example, it is well known in the art to interpose within a stenotic or occluded portion of an artery a self-expanding or balloon-expandable stent. Similarly, it is also well known in the prior art to use a stent graft to repair highly damaged or vulnerable portions of a vessel, particularly the aorta, thereby ensuring blood flow reducing the risk of aneurysm or rupture. .

A more challenging situation occurs when it is desirable to use a stent, graft or stent graft at or around the intersection between a major artery (for example, the abdominal aorta) and one or more intersecting arteries (eg renal arteries). The use of simple axial stents or grafts may seal

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2/82 effectively or block blood flow to the corresponding organs such as the kidneys. U.S. Patent no. 6,030,414 relates to such a situation, describing the use of a stent graft having lateral openings for alignment with the corresponding blood flow passages extending from the primary vessel in which the stent graft is positioned. The side openings are prepositioned within the stent based on the relative positioning identification of the side vessels to which they should be aligned. U.S. Patent no. 6,099,548 describes a multiple branch graft and a system for its distribution. Graft implantation is quite complicated, requiring a separate balloon-distributable stent to secure each side branch of the graft 15 within a designated branch artery. In addition, a plurality of stylets are required to apply the graft, taking up the space within the vasculature and thereby making the system less adaptable for smaller vessel implantation. In addition, graft and stent application 20 requires access and exposure to each of the branch vessels to which the graft is to be placed by means of a secondary arteriotomy. These techniques, while effective, can be cumbersome and somewhat difficult to employ and perform, particularly where the implant site involves two or more vessels crossing the primary vessel, which requires grafting.

The use of bifurcated stents for the treatment of abdominal aortic aneurysms (AAA) is well known in the state of the art. These stents have been specifically developed to solve problems arising from the treatment of defects and / or vascular diseases at or near the site of a bifurcation. The forked stent is typically configured in a trouser design comprising a body

3/82 or a tubular trunk and two tubular legs. Examples of bifurcated stents are disclosed in U.S. Pat. 5,723,004 and 5,755,735. Bifurcated stents may have unitary configurations or modular configurations 5 wherein the stent components are interconnected in situ.

In particular, one or both leg extensions are attached to a main tubular body. Although modular systems are easier to apply due to smaller component sizes, it is difficult to align and interconnect the legs with the body lumen quite accurately to prevent any leakage. On the other hand, although unitary stents reduce the likelihood of leakage, their larger structure is often difficult to apply to a treatment site that has a restricted geometry.

The highly curved aortic arch anatomy requires a stent that can accommodate multiple radii of curvature. More particularly, it is necessary that the stent wall be adaptable to the tightest radius of curvature of the underside of the aortic arch without twisting while still extending or stretching to accommodate the arch side without stretching the stent cells. superior longer yarn array beyond its elastic capabilities.

In addition, aortic of the person to which is placed a vessel of generally left, unnamed, branching equal to the artery variability of the person anatomy makes the same a graft site that if three, the carotid arch difficult to stent.

Although the number of originate from the arch is more know, common in some patients may be equal to one, some cases four, five or left subclavian artery, and most to the artery vessels usually six. In addition two and further, in spacing and angular orientation between the tributary vessels are variable from person to person.

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In addition, placement of stents / grafts within the aortic arch presents additional challenges. The aortic arch region is subject to blood flow and very high pressures that make it difficult to position a stent graft 5 without stopping the heart and placing the patient in cardiopulmonary bypass. In addition, even if the stent graft is placed correctly, it should be fixed in a manner that resists blood flow and constant high pressures and shear forces to which it is subjected over time to prevent it from migrating. or leak. In addition, the aorta undergoes relatively significant changes (approximately 7%) in diameter due to vasodilation and vasoconstriction. Thus, if an aortic arch graft cannot expand and contract to accommodate such changes, there may be an insufficient seal between the graft and the aortic wall, subjecting it to a risk of migration and / or leakage.

In order to achieve alignment of a side branch stent or side opening of the main stent 20 with a branch vessel, a custom stent manufactured according to the unique geometric limitations of each patient should be required. Measurements required to create a custom-made stent that fits the patient's unique vascular anatomy can be obtained using spiral tomography, computed tomography (CT), fluoroscopy, or another vascular imaging system. However, while such measurements and the associated manufacturing of a custom stent can be made, they do consume time and money. In addition, for patients requiring immediate intervention involving the use of a stent, such a custom stent is impractical. In these situations, it would be highly desirable that if you had a stent that could be

5/82 adjusted in situ when placed. It would likewise be highly desirable if it had a sufficient degree of fit to allow a distinct number of stents to be manufactured in advance and available to accommodate the required range of sizes and configurations found.

Another disadvantage of conventional stents and stent grafts is the limitations in position adjustment or subsequent recovery of the stent or 10 stent graft once delivered. Often, although the stent is distributed, the final position of the applied stent is determined to be no longer favorable to achieve the desired therapeutic effect. During delivery of self-expanding stents, the delivery mode consists of pushing the stent out of an delivery catheter or, more generally, retracting an outer sheath by securing the stent in a fixed position relative to the vasculature. In either case, the distal end of the stent is not attached to the catheter and thus can expand freely to its maximum diameter and seal with the surrounding artery wall. While this self-expanding capability is advantageous in stent distribution, it does present the user with a disadvantage when removing or repositioning the stent. Some designs use a lead wire to selectively retain the distal end of the stent until complete distribution is desired and accomplished by releasing the lead wire or tying the wire. The limitation of this design is the lack of ability to reduce the diameter of the entire stent length. The importance of not being possible to 30 stent diameter reduction. It is when positioning that blood flow is occluded by the fully expanded main body of the stent even though its distal end is trapped from the opening.

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Another disadvantage of conventional stent grafts is the temporary interruption in blood flow through the vessel. In the case of balloon-delivered stents and stent grafts, balloon expansion 5 itself when delivering the stent or stent graft causes blood flow to stop through the vessel. In addition, in certain applications, a separate balloon is used in a position distal to the distal end of the stent delivery catheter to actively obstruct blood flow 10 when the stent is placed. In the case of self-expanding stent grafts, misplacement of a stent graft may occur by interruption of arterial flow during delivery, requiring the placement of an additional stent graft in an overlapping form to complete vessel repair. Even without interruptions in flow, the strong momentum of arterial blood flow can cause a partially open stent graft to be pushed downstream by the high pressure pulsatile impact force of the blood entering the partially distributed stent graft.

Attempts have been made to overcome some of the disadvantages described above for conventional stents and stent grafts. For example, U.S. Pat. No. 6,099,548 describes the use of strands past and attached to the distal end of the stent which are introduced through a first opening into the vasculature. The ends of the cord are then passed through a second opening in the vasculature in such a way that they can be pulled, thereby moving the stent within the vasculature. Although the use of joined cords offers some additional control over stent placement, the skilled artisan may appreciate that the passage of cords within the vasculature through a second opening presents procedural difficulties. In addition, it is beneficial to the patient's welfare to minimize the

7/82 ​​number of surgical openings when performing any procedure.

With the limitations of current stent grafts and stent grafting technologies, there is clearly a need for improved devices and method. ^u- for the implantation of a stent or graft and for the treatment of vascular diseases and conditions that affect vessel interconnection (i.e. vascular trees) that eliminate the drawbacks of the prior art.

BRIEF DESCRIPTION OF THE INVENTION

The present invention provides implantable devices and systems and methods of distributing implantable devices within the body.

The implantable sites accessible by the devices in question may be any lumen or hollow or tubular tissue organ; however, the most typical implant sites are vascular structures, particularly the aorta. Thus, the devices of the invention are constructed in such a way that they can access implant sites that

0 it involves two or more intersecting tubular structures and thus are particularly suitable in the context of treating vascular trees such as the aortic arch and infrarenal aorta. Accordingly, implantable devices generally include a tubular member or lumen, more typically in the form of a stent, graft or stent graft, the devices may additionally include one or more transverse tubular members or branches or lumens which extend laterally from the primary or primary tubular member.

0 The devices and their lumens are formed by the interconnected cells, the cells being defined by the supports which are preferably made of an elastic or superelastic material in such a way that changes and

8/82 settings can feature length expansion formats,

Typically, it results when the stent is to be made in various dimensions, lumens of the device. Thus from one being one, reducing the other diameter or one or more lumens change in one dimension an opposite change in diameter of the stent lumen increases, and vice versa. The one of the device.

is dependent or other dimension, i.e. reduced in size, the construct length of the device material further allows one or more lateral branching lumens of the devices to be positioned at any appropriate position along the length of the main lumen and at any angle with respect to the longitudinal axis of the main lumen. Where there are two or more lateral branching lumens 15, the lumens may be axially spaced and may be circumferentially folded relative to each other to accommodate the target vasculature into which the implant is to be placed. .

The systems of the present invention are particularly suitable for applying and delivering the stent, graft or stent graft devices in question within a vessel or tubular structure within the body, particularly where the implant site surrounds two or more vessels. interconnected. In general, the delivery and delivery systems of the present invention allow independent control of each luminal end of an implantable device, where control may involve one or more application, positioning, placement, stretching, shortening, expansion and reduction actions. of a dimension 30 of the device. The systems further include devices for partially and / or completely distributing implantable devices as well as repositioning devices after at least partial distribution within the

9/82 vasculature.

Such independent control and distribution capabilities are provided by utilizing at least one element or member associated with the application system and releasably joined to each luminal end. Each element is independently manipulative relative to the other releasably joined elements. Accordingly, each luminal end of the implantable device may be individually and independently distributed as desired, where some or all of the luminal ends may be simultaneously distributed or may be serially distributed in any order that further facilitates the implantation procedure.

In one variation, the elements include a collection of elongate elements used to distribute implantable devices where the elongate elements may take any appropriate shape, including, but not limited to, cords, threads, filaments, fibers, yarns, strands, pipes, etc., wherein at least one elongate member is releasably attached to one, some or all of the luminal ends of the implantable device. In a particular embodiment, a cord collection is employed where a single cord is provided and used to control each proximal and distal end of the main lumen and for each lateral branching lumen of the implantable device. In another embodiment, a set of strands is used for each luminal end, where each set includes a strand at the apex of the ends of the device. The application systems in question include a device for selectively tensioning or pulling each of the single cord or the plurality of securing strings or elongating elements whereby the implantable device is selectively distributable to the

10/82 release tension on the fastening straps.

However, in other embodiments, something other than an elongate cord or member is used to control and retain at least one of the luminous ends. In a particular embodiment, the retention mechanism comprises a set of extensions, such as pins or hooks, that extend from the distal end of a catheter or guidewire associated with the delivery system. Extensions are used to couple the apexes of a luminal end into a releasable shape to retain that luminal end to be used together to receive the ends.

It may suitable implantable similarly with there being others besides use to distribute a receptacle or similar elements when apical detachable devices also selectively coils apex devices. For example, used in that used for repair of aneurysms, a current may be electrolysis means the stent point to facilitate a controlled erode end-to-stent release. Other release clamping devices that may be employed with the application systems to distribute the devices in question include, but are not limited to, thermal energy, mechanical or magnetic device, chemical device, any other thermal energy device, detachment device controllable.

distribution technique the device that or distributable in

Regardless of the type of device used, selective distribution allows implantable to be partially distributable increments or sections, where the implant can be fully or partially exposed from the application system without being fully released / distributed at the implant site.

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The implant delivery and delivery system in one embodiment includes a series of guidewires, a distal catheter portion and a proximal loop portion where the implantable device is loaded into the catheter portion prior to application to the target site. The catheter portion of the system is accompanied by at least one or more guidewires that direct and position the stent or stent graft and each of its branches within their respective targeted vessels selected for the implant. Several controls 10 are provided for selective tensioning and release of the luminal ends of the implant, where the controls may be located on the loop portion, catheter portion, or both. In a preferred embodiment, the catheter portion and / or application guide wires are pivotable at their distal ends to facilitate navigation through the vasculature.

One embodiment of the system includes an articulated application or a guide catheter.

guide wire of

The pivoting guidewire may have one or more pivot points to allow an operator to change the shape of the distal portion of the guidewire by manipulating the proximal portion of the guidewire. The guidewire may be pre-configured to change a linear configuration in a range of various preselected shapes arising from the control of individual pivot points 25 while manipulating the proximal portion of the guidewire. In this way, a guidewire can be produced with unique specifications for access to distinct areas of the vasculature. For example, this may be of particular importance for locating the implant within a region that requires an S-shaped path from the entry point to the implant target site. The introduction of a guidewire through a femoral artery access point leading to an implant target in the innominate artery shows an example of a

Potentially difficult S-shaped navigation passage where a hinged guide wire may be advantageous.

The methods of the present invention involve deploying the implantable device where some of the methods involve the use of the systems in question. Manufacturing methods of implantable devices are also provided.

Another object of the invention is to provide a stent delivery method that does not cause temporary occlusion of the vessel in which the stent is to be placed.

Another object of the invention is to provide a stent delivery method using the guidewires and an associated delivery system that enters the vasculature of a single access location.

An advantage of the stent delivery system of the present invention is that it does not require the use of space-occupying stylets and balloon catheters.

Another advantage of the system in question is that it allows adjustment of position or placement as well as removal of a stent during and after its distribution.

The present invention is further advantageous in providing a user with the ability to deliver a stent, assessing the suitability of the resulting delivery using standard imaging, such as using radiographic contrast and fluoroscopy or any other imaging system, if there is internal leakage between the covered stent wall and the surrounding arterial wall and detach the stent from the delivery system upon proper stent distribution or, In the case of improper distribution, reposition the stent in a new position and obtain a satisfactory result by repeating the stent application and removal, or completely removing the stent.

The present invention is further advantageous in that

Fix the stent from migration within the vasculature by integrating the lateral branching lumen cells into the main body lumen cells in such a way that when the lateral branching lumens are distributed within their branching vessels, The lumen of the main body is confined from migration by a lock and key mechanism. More specifically, interconnecting the side branch lumen to the main body lumen is performed by forming the side branch lumen and main body lumen from the same single wire where a specific wire wrap pattern is used to form a screen. to link the side branch lumen with the main lumen. Thus, when the lateral branch is distributed and held in place by the lateral branching artery, the main stent body cannot migrate. Furthermore, such a passive anchoring mechanism is non-traumatic, unlike the active anchoring device, such as burrs or hooks, which can damage implant site cell structures leading to smooth muscle proliferation, restenosis, and other vascular complications.

These and other objects, advantages and features of the invention will be apparent to those skilled in the art upon reading the details of the invention as more fully described below.

BRIEF DESCRIPTION OF DRAWINGS

The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to scale. In contrast, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Also for the purpose of clarity, certain

Features of the invention may not be described in some of the drawings. The following figures are included in the drawings:

Figure 1A illustrates one embodiment of a distributed implant of the present invention. Figure IB illustrates another embodiment of an implant of the present invention in a distributed, natural state. Figure 1C illustrates another embodiment of an implant wherein the lateral branching lumens are angular. Figure ID illustrates an end view of the implant of Figure 1C. Figure 1E illustrates another embodiment of an implant of the present invention having a heart valve operatively coupled thereto.

Figure 2A is a perspective view of a system of the present invention for applying and distributing the implants of the present invention within a tubular tissue structure within the body. Figure 2B is an enlarged perspective view of the portion of the system of Figure 2A that includes a side branch control and catheter hubs.

Figures 3A and 3B are side views of the side branch control and catheter hubs of the system of Figures 2A and 2B in open and closed configurations, respectively.

Figure 4 is a side view of the loop portions of the system of Figure 2A.

Figure 5A is a side view of the distal end of the delivery and delivery system of the present invention with an implantable device of the present invention shown partially distributed from the implant system. Figure 5B shows a top view of the system and implantable device of Figure 5A. Figure 5C shows a longitudinal cross-sectional view of Figure 5B.

Figure 6A is a cross-sectional view taken on

15/82 along line AA of Figure 5C. Figure 6B is a cross-sectional view taken along line BB of Figure 5C. Figure 6C is a longitudinal cross-sectional view of the catheter tip portion of the delivery and delivery system of Figure 5C.

Figures 7A, 7B and 7C are cross-sectional views of possible embodiments of side branch catheters of the present invention.

Figures 8A-8H illustrate various steps of a method of the present invention for applying a stent of the present invention using an implant system of the present invention.

Figure 9 illustrates another embodiment of the loop portion of the delivery and delivery system of the present invention.

Figure 10A illustrates a side view of an embodiment of an internal element of the catheter portion of the delivery and delivery system of the present invention. Figure 10B illustrates a cross-sectional view of the inner element of Figure 10A taken along line BB of Figure 10A. Figure 10C illustrates a cross-sectional view of the inner member of Figure 10 taken along the CC line of Figure 10A.

Figure 11 illustrates the partial distribution of the implant of Figure 1E within the aortic root.

Figures 12A-12F illustrate various steps of another method of the present invention for applying a stent of the present invention using an implant system of the present invention.

Figures 13A-13C illustrate various exemplary mandrel drawings for manufacturing the stents and stent grafts of the present invention.

Figure 14 illustrates a wire winding pattern.

16/82 of a stent of the present is a cross-sectional view of the application and device partially of the distal end of another system of the present invention with a present invention shown implantable from the implant system.

Figure 17 illustrates a perspective view of and distribution of the present

Figures 18A and 18B are cross-sectional side views of a dispensing / clamping mechanism at a distal end of the system of Figure 17 having an operably joined and distributed stent, respectively.

Figure 19 is a cross-sectional side view of the loop portion of the system of Figure 17 wherein a spring mechanism is employed for spring loading the dispensing / clamping mechanism of Figures 18A and 18B.

Figures 20A and 20B are cross-sectional side views of the system manipulation of Figure 17 and particularly illustrate the blasting characteristics of the system.

Figures 21A and 21B are side and top views, respectively, of the distal end of a steerable side branch catheter of an delivery / delivery system of the present invention operatively coupled with a side branch lumen of a stent of the present invention.

Figure 22 illustrates the use of lateral branch catheter steerability of the Figures

21A and 21B.

Figure 23 illustrates the use of a filter wire

17/82 with the side branch catheter of Figure 22.

Figures 24A and 24B are side and end views, respectively, of a sheath of an application / delivery system of the present invention having radiopaque markings.

Figure 25 is another sheath of the present invention having the walls reinforced with a braid material.

DETAILED DESCRIPTION OF THE INVENTION

Before the devices, systems and methods of the present invention are described, it should be understood that the present invention is not limited to the particular therapeutic applications and implant sites described, as these may vary. It should also be understood that the terminology used in the present invention is for the purpose of describing particular embodiments only and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as that generally understood by one of ordinary skill in the art to which the present invention belongs. The terms proximal and distal, when used with reference to the delivery and delivery systems of the present invention, should be understood to indicate user-related positions or locations where proximal refers to a position or location closer to the user and distal refers to the user. to a location or location farthest from the user. When used with reference to the implantable devices of the present invention, these terms should be understood to indicate positions or locations relative to an delivery and delivery system when the implantable devices are operatively positioned within the system. In this way, proximal

18/82 refers to a position or location closest to the proximal end of the delivery and delivery system and distal refers to a position or location closer to the distal end of the delivery and delivery system. The term implantable or implantable device as used in the present invention includes, but is not limited to, a device comprising a stent, a graft, a stent graft, or the like.

The present invention will now be described in more detail by the following description of embodiments and exemplary variations of the devices, systems and methods of the present invention. The invention generally includes an implantable device that includes a tubular element in the form of a stent, a graft or a stent graft, where the device may additionally include one or more laterally extending branching or tubular members. of the main or primary tubular element. The invention further includes a system for the percutaneous, endovascular delivery and delivery of the implantable device to a target implant site within the body. The implant site may be any lumen or tubular or hollow tissue organ; however, the most typical implant sites are vascular structures, particularly the aorta. A feature of the invention is that it relates to applications involving two or more intersecting tubular structures and thus is particularly suited in the context of treating vascular trees such as the aortic arch and infrarenal aorta.

IMPLANTABLE DEVICES OF THIS INVENTION

Referring now to the figures, and Figures IA and

IB in particular, exemplary embodiments of the implantable devices of the present invention are illustrated.

19/82 invention. Each device has a primary or main tubular member and at least one laterally extending tubular branch; however, the implantable devices of the present invention need not have side branches.

1A illustrates a variation of an implantable device 2 having a portion, body or primary tubular member 4 and laterally extending side branches 6a, 6b and 6c, interconnected and in fluid communication with the main body 4 by means of lateral openings within the body. The proximal and distal ends of the main tubular member 4 end at the crowns or apexes 8, the number of which may vary. The distal ends of the side branches 6a, 6b and 6c terminate at the crowns or apexes 10a, 10b and 10c, respectively, the number of which may also vary. Device 2 is configured particularly for the aortic arch implant where the primary tubular member 4 is positionable within the arch walls and the tubular branches 6a, 6b and 6c are positionable within the innominate artery, left common carotid artery, and subclavian artery. left respectively.

As will be described in more detail below, the distribution or fastening elements of the delivery and delivery systems in question are looped through the apexes 10a, 10b and 10c or through eyelets (not shown) extending from the distal ends of the apexes. of device 2. The fasteners of the present invention may be any elongate member including, but not limited to, strands, filaments, fibers, strands, stranded cables, tubing or other elongate member that is releasably attachable to the distal end of various lumens. of the stent. The release clamping devices

20/82 include, but are not limited to, electrolytic erosion, thermal energy, magnetic device, chemical device, mechanical device or any other controllable detachment device.

Figure 1B illustrates another variation of a device 12 having a portion or primary tubular member 14 and laterally extending branches 16a and 16b, interconnected and in fluid communication with the main body 14 through side openings within the body. The proximal and distal ends of the main tubular member 14 terminate at the crowns or apexes 18 which are employed as described above with respect to Figure 1A with the distal ends of the lateral branches 16a and 16b terminating at the crowns or apexes 18A and 18B, respectively. Device 12 is configured particularly for implantation in the infrarenal aorta where the primary tubular member 14 is positioned within the aorta walls and the tubular branches 16a and 16b are positioned within the right and left renal arteries, respectively.

Those skilled in the art will recognize that the implants in question may have any number and configuration of lumens (e.g., a single main lumen without side branch lumens, one main lumen and one or more side-branching lumens) where one or more side-branching lumens may be positioned at any appropriate position along the length of the main lumen and at any angle with respect to the longitudinal axis of the main lumen and where there are two or more lateral branching lumens, the lumens may be axially spaced and circumferentially bent relative to each other to accommodate the target vasculature into which the implant is to be placed. In addition, the length, diameter and shape

21/82 (e.g. radius of curvature) of each of the implant lumens may vary as needed to accommodate the vessel in which it is positioned. In certain applications, particularly when treating a vascular aneurysm having a relatively large neck section located near a junction between the main vessel and an affluent vessel, it may be preferable to provide a branched stent where the lateral branching lumens are relatively longer. longer than average. Longer stent branches can bridge the neck opening by maintaining sufficient length at its distal ends to extend a distance to a vascular side branch sufficient to support the stent.

Typically, the devices in question for most vascular applications will have a main branch lumen with a free length in the range of approximately 1 cm to approximately 25 cm and a free diameter in the range of approximately 2 mm to approximately 42 mm; and the side branching lumens have a free length in the range of about 0.5 cm to about 8 cm and a free diameter in the range of about 2 mm to about 14 mm. For aortic applications, the free length of the main lumen is typically about 8 cm to about 25 cm and the free diameter is in the range of about 15 mm to about 42 mm; and the side branching lumens will have a free length in the range of about 2 cm to about 8 cm and a free diameter in the range of about 5 mm to about 14 mm. Where dimension is the diameter of the main lumen of the stent, the reduced diameter is more likely to be closer to one tenth of the unreduced diameter. For renal applications, the main branch lumen will have a free length in the range of

About 2 cm to about 20 cm and a free diameter in the range of about 12 mm to about 25 mm; and the side branching lumens will have a free length in the range of approximately 0.5 cm to approximately 5 cm and a free diameter in the range of approximately 4 mm to approximately 12 mm. For coronary applications, the main branching lumen will have a free length in the range of approximately 1 cm to approximately 3 cm and a free diameter of approximately 2 mm to approximately 5 mm; and the side branching lumens will have a free length in the range from about 0.5 cm to about 3 cm and a free diameter in the range from about 2 mm to about 5 mm. For smaller vessel applications such as neurovasculature, these dimensions will naturally be smaller. In certain applications, particularly when treating a vascular aneurysm having a relatively large neck section located near a junction between the main vessel and an affluent vessel, it may be preferable to provide a branched stent where the lateral branching lumens are relatively longer. than the average. Longer stent branches can bridge the neck opening by maintaining sufficient length at its distal ends to extend a distance on a vascular side branch sufficient to support the stent.

It is also contemplated that the therapeutic or diagnostic components or devices may be integrated with the implants in question. Such devices may include, but are not limited to, prosthetic valves such as heart valves (for example, aortic or pulmonary valve) and venous valves, sensors for measuring flow, pressure, oxygen concentration, concentration glucose, etc., leads by stimulation

23/82 electrical, etc. For example, as illustrated in Figure 1E, an aortic root treatment implant 210 is provided which includes a mechanical or biological prosthetic valve 216 employed at a distal end of the main lumen 212. Device 210 additionally includes two lumens generally opposing minor lateral branching lines 214a and 214b adjustable for placement within the right and left coronary ostia, respectively. The length of the stent graft may be selected to extend to a selected distance where it terminates at any position anterior or subsequent to the aortic arch, for example, may extend to the descending aorta. Any number of additional lateral branches may be provided to accommodate the aortic arch branch vessels.

Those skilled in the art will appreciate that any appropriate stent or graft configuration may be provided for the treatment of other applications at other vascular positions or near the intersection of two or more vessels (e.g., bifurcated, trifurcated, quadrifurcated, etc.). .) including, but not limited to, aortoiliac junction, femoral-popiteal junction, brachiocephalic arteries, posterior spinal arteries, coronary bifurcations, carotid arteries, the superior and inferior mesenteric arteries, general bowel and stomach arteries, 25 cranial arteries and neurovascular bifurcations.

Stents and grafts of the present invention may be made from all appropriate materials known in the art. Preferably, the stent is constructed from a wire, although any suitable material 30 may be replaced. The wire stent must be elastically compliant, for example, the stent may be made of stainless steel, Elgiloy, tungsten, platinum or nitinol, but any other suitable material may be

24/82 used in its place or in addition to these commonly used materials.

Stents may have any suitable wire shape pattern or may be cut from a tube or a flat sheet. In one embodiment, the entire stent structure is fabricated from a single braided wire in a pattern of interconnected cells that form, for example, a closed-loop binding configuration. The structure may have a linear cylindrical configuration, a curved tubular configuration 10, a tapered hollow configuration, asymmetric cell sizes, for example, the cell size may vary along the length or around the circumference of the stent. In certain stent embodiments, the cell size of the lateral branching lumens is gradually reduced in the distal direction. This further facilitates the ability to selectively stretch the most distal portion of the lateral lumens and thereby makes it easier for a physician to guide the lateral branching distal end into a designated vessel. The ends of the main stent lumen and / or the end of one or more side branch stent lumens may be enlarged. Stent holders (i.e., the elemental portions that form a cell) may vary in diameter (in wire embodiments) or thickness or width (in sheet and cut tube embodiments).

In a particular embodiment, the stent is configured from a single wire. The single-wire stent configuration is advantageous in that the selective interlacing of the attachment points along the stent length provides an adjustment in the angular orientation of the side branch stents relative to each other and to the stent lumen. within a selected range that can accommodate any possible variation in the anatomy being treated. Such angular orientation of the lumens of

Lateral branching can be axial, circumferential, or both.

Figure 1C illustrates an implant device 20 wherein lateral branching lumens 24 and 26 have an angular orientation defined by angle a with respect to the main lumen 22 and have an angular orientation defined by angle β with respect to each other. others. Figure ID is an end view of implant device 20 illustrating the circumferential orientation, defined by angle Θ, between lateral branch lumens 22 and 24. Typical ranges of the various angles are as follows: from about 10 ° to about 170 ° to the angle o from 0^O approximately 170 ° for angle β, and from 0^O at 360 ° for angle Θ. These orientations can be provided by the production process, resulting in a stent that has naturally inclined orientations in a free, pre-distributed condition, ie the neutral state. One or more of these orientations may be selectively adjusted within the angle ranges provided above when applying and placing the branch lumens within the respective vessel lumens. This design also allows for adjustability in linear spacing between side branch stents by stretching and / or shortening the main lumen of the stent. In addition, the side branch portions may be lengthened to permit placement of an oversized stent in a smaller branch vessel thereby providing adequate juxtaposition between the stent wall and the vessel. It should be noted that stent adjustability does not compromise the radial force required to secure or prop and prevent migration and internal leakage of the device.

The devices in question may also be manufactured in such a way that their lumens have constant or variable stiffness / flexibility along their

26/82 lengths as well as around their circumferences. Greater flexibility can better accommodate the curvilinear vasculature encountered during application and at the implant site. This feature is highly beneficial in aortic arch stent applications due to the relatively tight arc curve. Enhanced stiffness, on the other hand, particularly at the end portions of a lumen, confers greater radial force thereby resisting migration of the device within the vasculature after placement. Variable flexibility / stiffness can be performed in a variety of ways.

The size or thickness of the holder (ie the elemental portions that form a stent cell) used to make the devices may vary, with thicker gauges giving greater rigidity and thinner gauges giving greater flexibility. Stent holders may vary in diameter (in wire embodiments) or thickness or width (in sheet and cut tube embodiments). In one variation, a single strand or filament may be used where the gauge selectively varies along its length. The thicker portions of the caliber are used to form at least the end portions of the stent lumen to increase their radial force, thereby reducing the risk of stent migration. On the other hand, the narrowest gauge portion of the wire forms at least a central portion of the main stent lumen (and side branch lumen portions) that may be relatively more flexible than the end portions to facilitate stent application. within the winding or curved vasculature or allow the device to be compacted into the application sheath more easily. For aortic stent applications, this can be accomplished by a wire that has portions of one to two centimeters in each of

27/82 their ends having a larger diameter than the remaining central portion. Another example for selectively reducing the cross-sectional diameter of the wire is to decrease the diameter of the side branch stent holders.

In other embodiments, more than one yarn is used, with each yarn having constant gauges along their respective lengths, but differing from yarn to yarn. A larger gauge wire may be used to form stent ends or other areas where increased stiffness is required, and a narrower gauge wire may be used to form other portions, for example the central portions of the stent lumens. where increased flexibility is required. Additionally or alternatively, the larger gauge wire may be selectively bent or wrapped with the narrow gauge wire at selected points or positions on the stent to support rigidity at those particular sites.

In one variation, two or more wires may be employed to form the device whereby the ends of the wire, i.e. four ends of the wire in the case of a two-wire device, are joined. The location over the lumens where the wires cross and / or where their ends are joined is selected to minimize stiffness in certain areas along or over the lumen and / or to intensify stiffness in one or more areas of the device. , that is, to provide relative stiffness and flexibility between the stent portions. For example, in aortic arch applications, the portion of the main lumen of the stent that should be aligned along the lower arch wall is preferably relatively more flexible and / or less rigid than the portion of the stent that should be aligned along the arch. upper wall of the arch, since the lower wall has a tighter radius of curvature.

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Accordingly, it may be desirable to minimize the joining and / or intersecting points of the wires along this portion of the stent.

It may also be desirable to provide greater stiffness at the junction between the lumen and the main side branching lumens. Aortic aneurysms, and particularly aneurysms located at the intersection of the aortic arch and one or more of its affluent vessels, may result in relatively large volumes of perimeters not defined in this manner, ie sacs, within the vasculature. Without a vessel wall against which it can be propped, a stent joint may be more susceptible to coiling. The stiffness of the stent junction points can prevent such curl.

Copending US Patent Application No. 11 / 539,478 filed October 6, 2006 and another US Patent Application (which has Attorney No. DUKEPZ01101) filed contemporaneously therewith, both entitled Vascular Implants and Methods of Fabricating the Same, and incorporated herein by reference, describe stent devices that have many of the features to selectively enhance the stiffness and flexibility properties described above. .

As mentioned above, implantable devices of the present invention may include a stent or graft or a combination of the two, referred to as a stent graft, a stent graft or a grafted stent. The graft portion of a stent graft may be made of a textile material, polymer, latex, silicone latex, polyethyl fluoroethylene, polyethylene, Dacron polyesters, polyurethane or the like, or a suitable material such as a biological tissue. Graft material must be flexible and durable in order to withstand the

29/82 effects of installation and use. One skilled in the art will appreciate that the grafts of the present invention may be formulated by many different well known methods such as, for example, weaving, or may be formed by dipping a substrate into the desired material. Exemplary graft production methods are described in the above-mentioned contemporary filed US Patent Application.

Biological tissues that may be used to form the graft material (as well as the stent) include, but are not limited to, extracellular matrices (ECMs), acellularized uterine wall, decellularized sinus cavity lining or membrane, ureture membrane acellular, cord tissue, decellularized pericardium and collagen. Suitable ECM materials are derived from mammalian host sources and include, but are not limited to, small intestine submucosa, liver base membrane, urinary bladder submucosa, stomach submucosa, dermis, etc. Extracellular matrices suitable for use with the present invention include mammalian small intestine submucosa (SIS), stomach submucosa, urinary bladder submucosa (UBS), dermis or sheep-derived liver base membranes, bovine, porcine or any appropriate mammal.

Submucosal tissues (ECMs) of warm-blooded vertebrates are useful in tissue grafting materials. Small intestine-derived submucosal tissue graft compositions have been described in U.S. Pat. No. 4,902,508 (hereinafter, '508 Patent) and U.S. Pat. No. 4,956,178 (hereinafter, '178 Patent) and urinary bladder-derived submucosal tissue graft compositions have been described in U.S. Patent No. 4,596,178. 5,554,389 (hereafter,

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Patent '389). All of these compositions (ECMs) generally comprise the same layers of tissue and are prepared by the same method, the difference being that the starting material is small intestine on the one hand and the urinary bladder on the other. The procedure detailed in the '508 patent, incorporated by reference in the' 389 patent, and the procedure detailed in the '178 patent, includes mechanical wear steps for removing the inner layers of the tissue, including at least the luminal portion of the mucous membrane of the intestine or bladder, that is, the mucosa of the epithelial lamina (epithelium) and lamina propria, as detailed in '178 patent. Abrasion, peeling or scraping of the mucosa delaminates the epithelial cells and their associated base membrane and most of the lamina propria, at least at the level of a dense organized connective tissue layer, the compact stratum. Thus, the tissue graft material (ECMs) previously recognized as the soft tissue replacement material is devoid of the epithelial base membrane and consists of the submucosa and compact stratum.

Examples of a typical epithelium having a base membrane include, but are not limited to: the epithelium of the skin, intestine, urinary bladder, esophagus, stomach, cornea and liver. The epithelial base membrane may be in the form of a thin sheet of extracellular material contiguous with the basilar appearance of the epithelial cells. Aggregated epithelial cell leaves of a similar type form an epithelium. The epithelial cells and their associated epithelial base membrane may be positioned in the luminal portion of the mucous membrane and constitute the inner surface of tubular and hollow organs and tissues of the body. Connective and submucosal tissues are positioned, for example, on the abluminal or deep side of the base membrane. Examples of connective tissues

31/82 used to form the ECMs that are positioned on the abluminal side of the epithelial base membrane include the bowel and urinary bladder submucosa (UBS) and the dermis and subcutaneous tissues of the skin. The submucosal tissue may have a thickness of approximately 80 micrometers, and consists mainly (more than 98%) of a cellular eosinophilic pretend (H&E pretense) matrix material. Occasional blood vessels and spindle cells consistent with fibrocytes may be randomly dispersed in any tissue. The material is typically rinsed with saline and is optionally stored in a frozen hydrated state until use.

Fluidized UBS, for example, may be prepared in a similar manner to the preparation of fluidized intestinal submucosa, as described in U.S. Pat. 5,275,826, the disclosure of which is expressly incorporated herein by reference. The UBS is fragmented by tearing, cutting, grinding, shearing or the like. Grinding UBS in a frozen or freeze-dried state is preferred, although good results can also be obtained by subjecting a suspension of parts of the submucosa to treatment in a high speed mixer (high shear) and draining, if necessary,. by centrifuging and decanting excess water. In addition, the fragmented fluidized tissue may be solubilized by enzymatic digestion of the bladder submucosa with a protease such as

<td>trypsin</td><td>Or the</td><td>pepsin, or</td><td>per</td><td>middle of</td><td>others</td><td>enzymes</td>

<td>appropriate</td><td>per</td><td>a period</td><td>in</td><td>time ι</td><td colspan="2">enough to</td>

<td>solubilize</td><td>O</td><td>said fabric</td><td>and</td><td>to form</td><td>an</td><td>solution</td>

substantially homogeneous.

Coating for the stent may consist of powdered forms of UBS. In one embodiment, a powdered form of

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UBS is prepared by spraying urinary bladder submucosa tissue with liquid nitrogen to produce particles ranging in size from 0.1 to 1 mm.². The particulate composition is then lyophilized until the next morning and sterilized to form a substantially solid anhydrous particulate compound. Alternatively, a powdered form of UBS may be formed of fluidized UBS by drying the suspensions or the fragmented UBS solutions.

Other examples of ECM material suitable for use with the present invention include, but are not limited to, fibronectin, fibrin, fibrinogen, collagen, including fibrillar and non-fibrillar collagen, adhesive glycoproteins, proteoglycans, hyaluronan, acid secreted protein and cysteine-rich (SPARC), thromboespondins, tenacin and cell adhesion molecules, and matrix metalloproteinase inhibitors.

The stent may be processed in such a way that it adheres to an ECM (or other material) sheath only to the wire and does not extend between wire segments or within stent cells. For example, energy in the form of a laser beam, current or heat may be applied to the wire stent structure while the ECM is placed in contact with the underlying structure. Thus, as cooking meat in a hot pan leaves tissue, ECM could be applied to the stent in such a way.

Subsequent to the implantation of the devices in question, the ECM portion of the implant is finally resorbed by the surrounding tissue, assuming the cellular characteristics of the tissue, for example the endothelium, smooth muscle, the adventitia, in which it was resorbed. In addition, an ECM support structure having a selected configuration may be operatively attached to a stent or stent graft of the present invention in a position

33/82 is selected whereby the ECM material is subjected to remodeling subsequent to the native tissue structures at the selected position. For example, the ECM support structure may be positioned in the ring of a previously removed natural aortic valve configured in such a way as to create the structural characteristics of aortic valve leaflets and whereby the implant provides valve function.

The stents, grafts and / or stent grafts in question may be coated to provide local application of a therapeutic or pharmaceutical agent to the disease site. Local application requires lower dosages of the therapeutic or pharmaceutical agent applied to a concentrated area, as opposed to systemic dosages, which require multiple administrations and loss of material before reaching the targeted disease site. Any therapeutic material, composition or drug may be used including, but not limited to, dexamethasone, tocopherol, dexamethasone phosphate, aspirin, heparin, cumadin, urokinase, streptokinase and TPA or any other appropriate thrombolytic substance to prevent thrombosis in the body. implant site. Additional therapeutic and pharmacological agents include, but are not limited to, tannic acid simulating dendrimers used as submucosal stabilizing nanocorrosives to increase resistance to proteolytic degradation as a device to prevent the development of post-implant aneurysm in support structures. natural vascular cells, cell adhesion peptides, collagen mimetic peptides, hepatocyte growth factor, proliferative / antimitotic agents, paclitaxei, epidipodophyllotoxins, antibiotics, anthracyclines, mitoxantrone, bleomycins, plicamycin and mitomycin, enzymes,

Antiplatelet agents, non-steroidal agents, heteroaryl acetic acids, gold compounds, immunosuppressants, angiogenic agents, nitric oxide donors, antisense oligonucleotides, cell cycle inhibitors and protease inhibitors.

For agent application purposes, the stents, grafts and / or stent grafts in question are coated with a primer layer on one surface. The primer layer forms a reservoir for containing the therapeutic / pharmaceutical agent. The overlap region between the primer layer and the active ingredient may be modified to increase the permeability of the primer layer to the active ingredient. For example, by applying a common solvent, the active ingredient and the surface layer mix together and the active ingredient begins to be absorbed into the primer layer. In addition, the primer layer may also be treated to produce an uneven or rough surface. This rough area captures the active ingredient and enhances the diffusion rate of the ingredient when the stent is introduced into the patient's body. Thus, the implant has the ability to diffuse drugs or other agents at a controllable rate. Furthermore, one skilled in the art will understand that the present invention may provide a combination of multiple coatings, such as the primer layer may be divided into multiple regions, each containing a different active ingredient.

The implants in question can also be seeded with cells of any type including stem cells to promote angiogenesis between the implant and the arterial walls. The methods included applying a porous coating to the device, which allows tissue to grow in the interstices of the implant surface. Other efforts to improve host tissue capacity

Growth and adherence of the implant to the host tissue involved the inclusion of an electrically charged or ionic material on the surface of the device in contact with the tissue.

The stent, graft or stent graft of the present invention may also include a sensor or sensors for monitoring the pressure, flow, velocity, turbidity and other physiological parameters as well as the concentration of a chemical species such as for example, glucose, pH, sugar, blood oxygen, glucose, humidity, chemical, ionic, enzymatic, and oxygen levels. The sensor should be designed to minimize the risk of thrombosis and embolism. Therefore, retardation or interruption of blood flow at any point within the lumen should be minimized. The sensor may be directly attached to the outer surface or may be enclosed within a package or attached within the stent material, graft or stent graft of the present invention. The biosensor may additionally employ a wireless device for distributing implant site information to an instrument external to the body.

The stent, graft or stent graft may be made of visualization materials or may be configured to include marking elements, which provide an indication of device orientation to facilitate proper stent alignment at the implant site. Any suitable material capable of radiopacity may be used including, but not limited to, barium sulphate, bismuth trioxide, iodine, iodide, titanium oxide, zirconium oxide, metals such as gold, platinum, silver, tantalum. , niobium, stainless steel and combinations thereof. The entire stent or any portion thereof may be made of or marked with a radiopaque material, i.e. the crowns of the stent.

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DEVICE MANUFACTURING METHODS

The stent of the present invention can be manufactured in many ways. One method of stent manufacturing is by use of a mandrel device such as the mandrel devices 320, 330 and 340 illustrated in Figures 13A-13C, respectively. Each device has at least one main component 322, 332 and 342, respectively, with a plurality of selectively positioned small chuck holes 324, 334 and 344, respectively, within which a plurality of pins (not shown) are selectively positioned. , or from which the pins are extended. As described in more detail below, the stent structure is formed by selectively wrapping a wire around the pins. Where the stent should have one or more side branch lumens, the mandrel device, such as device 340, may be provided with at least one lateral mandrel 346 extending substantially transversely of the main mandrel 342, where the number of side mandrels preferably corresponds to the number of lateral branches of the stent to be formed. Arbor devices can be modular where side branching chucks of varying diameter and length can be detachably mounted to the main arbor. The master mandrel as well as the side branch mandrel configuration may be of any shape, size, length, diameter, etc., suitable to form the desired stent configuration. Generally, the mandrel components have a linear cylindrical configuration (see Figures 13A and 13C) that have a uniform cross section, but may be tapered with varying diameters over a length dimension (see Figure 13B) of tapered stem having an oval cross section, a curved shape, etc.

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The pins may be retractable within the mandrel components or are removable and selectively positionable within the holes formed in the mandrel components. In addition, the chuck device can be configured to selectively extend and retract the pins. The number of pins and the distance and spacing between them can be varied to provide a custom configuration pin. This customization allows the production of stents that have variable sizes, lengths, cell sizes, etc., using a limited number of mandrel components. For example, in one variation, the pins are arranged over the mandrel components in an alternating pattern, such as, for example, where four out of eight small holes per row will be filled with the pins. Alternatively, a selection of mandrels can be provided, each of which has a unique small hole pattern which in turn defines a single cell stent pattern.

For stent formation, a shape memory wire, such as a NITINOL wire, having a selected length and diameter, is provided. Typically, the length of the wire ranges from about 9 to about 12 feet in length, but may be longer if necessary or shorter if more practical. The wire diameter is typically in the range of from about 0.001 to about 0.020 inch. After a mandrel device is provided which has winding pins at the desired points or positions on the mandrel components, the wire is wound over the pins in a selected direction and in a selected top and bottom loop pattern, for example. a zigzag pattern to form a series of interconnected wavy rings resulting in a desired cell pattern.

An exemplary 350 wire winding pattern

38/82 is shown in Figure 14. Starting from one end of the main mandrel, wire 352 is wound around pins 354 in a zigzag pattern back and forth from one end of the main mandrel to the other until the cells of the main lumen of the stent are formed. Next, the same wire, still attached to the mandrel device, is used to form the lateral branching lumen where the wire is wrapped in a zigzag form from the base of the lateral branching mandrel to the distally extending end and to the rear. , again until all side branch cells are created. The wire is then wound over the main mandrel along a path that is at an angle to the longitudinal axis of the main mandrel where the wire is bent over itself along certain segments of cell 356. It should be noted that any lumen of the stent may be manufactured first, followed by others, or the coiling pattern may be such that portions of the various lumens are formed intermittently.

The arbor device with the formed wire stent pattern is then heated to a temperature in the range of approximately 480 ° C to approximately 520 ° C and typically to approximately 490 ° C for approximately twenty minutes; however, this time may be reduced by using a salt bath. The duration of the hot consolidation step is dependent on the time required to move the wire material from a martensitic to austenitic phase. 0 The set is then air-cooled or placed in a water bath to cool sharply for thirty seconds or more and is then placed to air dry. Once the stent is sufficiently dry, the pins are pulled from the mandrel device or retracted to the hollow center of the mandrel by driving an inner part that projects the pins to

39/82 out of their respective holes in the outer surface of the mandrel. The stent with its interconnected lumens can then be removed from the mandrel device. Alternatively, with the mandrel components detached from one another, one of the lumens, for example the main stent lumen, can be formed first by forming a side branch lumen after attaching a side mandrel to the main mandrel. .

Optionally, selected regions of the main body 10 or portions of the wire forming lateral branch lumen cells may be selectively reduced in diameter through corrosion or electropolishing to exert less radial force than that portion of the stent wire that was not reduced in wire diameter. An example of a selective reduction in wire diameter in the main body of the stent is to leave a circumferential portion of one to two centimeters at each proximal and distal end to allow the high radial force in these regions to protect the stent from migration while the central portion 20 between these regions of high radial force may be reduced in cross-sectional wire diameter to facilitate stent stretching more easily during placement or allow it to be compressed into the application sheath more easily over a long length. Another example of selective wire diameter reduction in cross section is to decrease the diameter of the side branch supports. This can be done by selective side-branch immersion in an acid during manufacture to reduce the amount of metal in a particular 30 stent region. Another method to achieve the desired result of preferentially reducing the longitudinal branching stiffness and / or the external radial force of the lateral branching component is to use a

40/82 electropolishing. By placing the braided solid wire stent in an electrolyte bath and applying a voltage potential through an anode-cathode opening, where the stent itself is the anode, the metal ions are dissolved in the electrolyte solution. Alternatively or subsequently, the process may be reversed, whereby the stent becomes the cathode and the lateral branch or other selected region of the stent may be electro- plated with a similar or different metal in the ionic solution, for example gold or platinum. to change the mechanical properties or to enhance the radiopacity of the selected region. Elements skilled in the electroplating and electropolishing technique will recognize that there are techniques that utilize an etching layer of a substrate-like material to enhance the bonding of a dissimilar material to the substrate. An example would be the use of a pure nickel etching layer on top of a titanium substrate (NITINOL) in order to subsequently bond a gold or platinum coating to the substrate.

Another method of manufacturing the stent is to cut a thin-walled tubular element, such as a stainless steel tubing, to remove the tubing portions in the desired stent pattern, leaving relatively untouched the metal tubing portions that are to form the stent. . The stent can also be made from other metal alloys such as tantalum, nickel titanium, cobalt chrome, shape memory titanium and superelastic alloys and noble metals such as gold or platinum.

According to the invention, one skilled in the art should know that several different methods may be employed for the manufacture of the stents in question, such as the use of different types of lasers; chemical corrosion; electric blasting machinery; laser cutting of a sheet

41/82 smooth and winding in a cylinder; all of which are well known in the state of the art.

Where a stent graft 360 must be formed by the addition of a graft material 362, such as an ECM, to the stent 364 in question, any way of joining the graft material to the shape of the wire may be used. In one variation, the graft material is joined by a suture 366. In this manner, an edge 370 of the graft material is sewn longitudinally to the stent structure along the length of the stent, where at least one knot 368 is tied at each stent apex to secure one end of the graft to the stent. Next, the graft material is stretched around the stent surface and the opposite edge 372 of the graft is overlapped with the already joined edge 370 and is independently sewn to the stent structure to provide a free escape surface against which blood Can't escape. The graft material is stretched to an extent to match stent compliance so that it is not collapsed when the stent is in the expanded state. Upon complete fixation of the graft material to the stent, the graft is dehydrated so that it shrinks comfortably to the stent structure similar to how the tubing would shrink when heated.

APPLICATION AND DISTRIBUTION SYSTEMS OF THIS INVENTION

Referring now to Figures 2A and 2B, a system 30 of the present invention for implanting the devices of the present invention is shown. System 30 includes a distal catheter portion 32 and a proximal or loop portion 34. The portion of the catheter 32 is configured for positioning within the vasculature or other passage leading to the implant site and includes a plurality of elongate elements having a plurality of lumens, many of which are multifunctional to the guidewire, the leadwire. traction and

Fluid passage from one end of the device to the other. The catheter portion 32 includes a translatable outer sheath 38 which has a lumen within which an intermediate element 40 is received. The proximal end of the outer sheath 38 is configured with a socket 50 to engage a distal hub 52 of the intermediate portion 40. The socket 50 is configured with an internal valve mechanism that fluidly seals the luminal space between the walls of the outer member 38 and the intermediate member 40, thereby preventing blood from leaking therefrom. The socket 50 may additionally include a blast port (not shown) for evacuating any residual air as is common in catheter preparation. An inner member 42 is received and translatable within a lumen 138 (see Figure 6A) of intermediate member 40 and defines a guidewire lumen of the main body 44 for translating a guidewire 48 therethrough. The inner member 42 terminates at a distal conical tip 46 which facilitates forward translation of the device through the sinuous vasculature. The outer element, intermediate element, and inner element tubing (as well as some catheter components discussed below) may be made from materials used to construct conventional intravenous sheaths and catheters, including, but not limited to, biocompatible reinforced plastics. braided materials or any other biocompatible material that is substantially flexible.

The proximal portion 34 of delivery and delivery system 30 includes proximal and distal loop portions 36a, 36b which are axially translated with respect to one another. Inner member 42 is attached to proximal handle portion 36a and intermediate member 40 is attached to distal handle portion 36b in such a way that separation and

The axial extension of the two handle portions relative to each other controls the amount of extension and shortening subjected by an operatively loaded stent within the application system, as will be explained in more detail below.

As mentioned above, in a variation of the present invention, the implantation and distribution of an implant is performed by use of a plurality of designated attachment lines, cords, wires or filaments. More particularly, a single cord or set or plurality of cords is provided for releasably controlling and securing each free end of the implant to the delivery system. Two strands or separate sets of strands are employed to control the main tubular portion of a strand of an implantable device or a set of strands to control the distal end and another to control the proximal end of the device. For each lateral branch of the implant, an additional cord or set of cords is provided. The number of cords in each set correlates with the number of crowns or connection points provided at the respective ends (i.e., proximal and distal ends of the main stent portion and distal ends of the branching portions) of the device. Each lanyard is interwoven with a designated crown with both ends positioned and controlled on the device loop, where one end of each lanyard is permanently attached to the delivery and dispensing system 30 and the other end releasably attached to the delivery system. application and distribution 30. When operatively loaded into system 30, the luminal ends of the implant are releasably joined to the various portions of system 30. For example, the distal end of the lumen.

44/82 of the stent is releasably attached to the inner member 42, the proximal end of the main stent lumen is releasably attached to the intermediate member 40 and the distal end of each side branch stent is releasably attached to a side branch catheter designated 150 (see Figure 6A).

Figures 21A and 21B illustrate an arrangement whereby a side branch catheter 460 carries, directs and distributes a side branch lumen of stent 468. A single delivery cord 470 which comes from a lumen of cord 464a within catheter 460 is grooved or braided around the appendages 474 of side branch stent 468 and exits through another lumen of cord 464b within catheter 460, where both The ends of the cord 470 are retained at a proximal end of the delivery system as discussed above. Control and steerability of side branch catheter 460 is performed in part by the use of side branch guide wire 466, as shown in Figure 22, passed through the guide wire lumen of catheter 462. The manner in which the cord 470 holding and securing the distal end of the side branch stent 468 to the outside of catheter 460 also provides control and steerability. As best illustrated in Figure 22, the resulting tension placed at the end of the distal catheter 460 by the side branch 468 allows controlled movement and directionality of the catheter. For example, translational movement of catheter 460 longitudinally in an axial direction 477 results in forward and backward movement, that is, movement parallel to or in the same plane with the main stent lumen 462 of the distal end of the catheter, such as indicated by arrows 475a, 475b. On the other hand, the rotational or twisting motion 480 of the catheter body 460 results in lateral movement, that is, in the

Lateral movement to or in a plane perpendicular to the axis of the main stent lumen 472, i.e. the distal end of the catheter.

Each tie-down or set of tie-downs is controlled, that is, they can be fixed, released, tensioned, pulled, tightened, etc., by a designated control mechanism. Accordingly, the number of control mechanisms provided in the illustrated embodiment of the system in question corresponds to the number of locking cord assemblies; however, control of bead assemblies can be consolidated into fewer control mechanisms.

The various control mechanisms may be of any suitable configuration and may be mounted at any appropriate position in system 30 where an exemplary configuration and position 15 of the control mechanisms is illustrated in

Figure 2A. In particular, each control mechanism includes a pair of controls in the form of buttons, selectors, switches or keys, for example, where a control is for linear translation, ie the draw of the cords at their fixed ends through the system. 30 when distributing the implant, and the other control is to selectively release and fix the free ends of the cords prior to implant distribution.

Controls 70a, 70b and 72a, 72b for controlling the distal and proximal luminal ends, respectively, of the implant, are provided in loop portions 36a and 36b, respectively. An additional pair of controls for each set of attachment strands associated with each side of the implant or side branch lumens is provided in a releasably mounted hub to the intermediate element where the collective hubs are arranged in series between the proximal end 50. of the outer sheath 38 and the distal end of the distal loop portion 36b. For example, for use

46/82 with implant 2 of Figure 1A which has three branching lumens 6a, 6b and 6c, three hubs 74, 76 and 78 and associated control pairs respectively are provided where the most distal control pair 74a, 74b controls the fixation cords for the most distal branching lumens of stent 6a, the second middle pair or pair of controls 76a, 76b controls the cords for the middle stent branching lumen 6b and the most proximal control pair 78a, 78b controls the attachment strands to the most proximal of the stent branch lumens 6c.

Each pair of controls includes a fixed end member 70a, 72a, 74a, 76a and 78a, here in the form of a button, to which a set, the fixed set, of the ends of the tie strands is permanently anchored but is removable from the respective loop portion or the hub to manually pull the strings therethrough. This control maintains a constant tension on the attachment strands and maintains the implant contained within the delivery system, although the delivery system is articulated through the vasculature. As best illustrated in Figure 2B, each knob is positioned within a hemostatic valve 80 to prevent fluid backflow, for example, blood, out of the handle or hub before and after the knob is removed from it. Each pair of controls also includes an end member or releasable clamp 70b, 72b, 74b, 76b and 78b, here in the form of a selector or a movement screw, whereby the free ends of the strand assembly are propped. releasably to the handle portion or the respective hub. When ready to distribute a respective luminal end of the implant, the drive screw is selectively loosened to allow tension to be released into the respective cord assembly. The elements versed in the

It will be appreciated that the relative positioning and arrangement of the various control mechanisms may vary with the intention of providing an organized, ergonomically designed profile.

Referring now to Figures 2B, 3A and 3B, each side branch control hub 74, 76 and 78 is associated with a distally positioned side branch catheter hub 84, 86 and 88 respectively (only the most proximally positioned hubs 78). and 88 are 10 illustrated in Figure 2B). Between each pair of hubs extends a proximal portion 94a 94b, 94c of the side branch catheters 150a, 150b, 150c, respectively (see Figure 6A), which extends from a sealable port 110a, 110b, 110c (see Figure 2B) at the rear end of each control hub 15 74, 76 and 78 to a distal end and through the respective lumens of the side branch catheter 148 within intermediate member 40 (see Figure 6A). Within each side branch catheter 150a, 150b,

150c there is a lumen of side branch guidewire 152a, 152b, 152c (see Figure 6A). Port 110a, 110b, 110c allows entry and passage of a side branch guidewire 154a, 154b, 154c (see Figure 6A) through a respective side branch guidewire lumen 152, One or both of these. lateral branching catheters and lateral branching guidewire may be deflectable. Each of the control hubs 74, 76 and 78 is slidably coupled to intermediate member 40. The undersides of the control hubs have clamp 96, a partial ring configuration or the like such that the hubs 30 are completely releasable from the intermediate element 40 as well as slidable thereon. As mentioned above, each of the lateral branch stent lumens is releasably coupled to the distal end of the catheter.

Lateral branching 150a, 150b, 150c by a designated anchor cord or set of anchor cords. Regardless of the relative position between the branch control side hubs 74, 76, 78 and the associated side branch catheter hubs 84, 86, 88, the clamping cord assemblies are maintained at full tension in both configurations illustrated in the Figures. 3A and 3B until released by their respective control knobs 74b, 76b and 78b. When the control hubs are in a distal or near position relative to the catheter hubs as illustrated in Figures 3Ά and 3B, where the proximal portion 94a 94b, 94c of the side branch catheter 150a, 150b, 150c is received completely within of the associated catheter hub, lateral branching stents are maintained in a partially distributed state. In the partially distributed state, the lateral branching stents are held straight, with tension being applied by the distal end of the respective extended lateral branching catheter 94a, 94b, 94c removably attached to the distal end of the lateral branching stent apexes stretched or connection points by the respective cord of the side branch catheters or the cord assembly. The tension being applied to the distal end of each side branch stent is transferred through the side branch stent, thereby lengthening its length while simultaneously reducing the diameter. This allows the placement of a larger diameter stent within a smaller diameter side branch vessel. This partially distributed state, that is, where the lateral branching stent diameter is smaller than the lateral branching vessel in which it is being placed, also allows blood flow around and through the implant, which allows, thereby perfusion of vessels and organs downstream during placement. IS

It is preferable to allow blood to continue to flow through the intersecting lateral branching vessels during the procedure to avoid ischemia to the downstream affected organs. The lateral branching stent is stretched by the extension of the lateral branching catheter that is releasably attached to the crowns of the distal end of the lateral branching stent. Stretching the lateral branching stent allows its subsequent placement within a targeted, undersized lateral branching vessel. Typically, the diameter of a free-standing lateral branching stent is approximately 5% to approximately 50% larger than the diameter of the lateral branching vessel in which it is to be placed. On the other hand, when the control hubs are in a proximal or retracted position as illustrated in Figures 2B and 3A, each side branch stent is maintained in a distributed or unstretched condition.

Side branch catheters 150a, 150b, 150c slidably extend at their proximal ends 94a, 94b, 94c through respective side branch catheter hubs 84, 86, 88 and a hemostatic valve 92a, 92b, 92c positioned at the posterior end of the catheter hub. Each side branch control hub 74, 76, 78 has a Luer socket 110a, 110b, 110c (where only 110c is shown) that allows a hemostatic valve (not shown) to be applied. The hemostatic valve can be a Y-arm adapter or a Toughy-Borst adapter that allows the sealed introduction of a guidewire. Y-arm Luer fitting allows air to clear the guidewire lumen when blasting the saline catheter before introducing the catheter into the body. In subsequent stages of the procedure, this lumen can be used to introduce radiographic contrast to visualize

50/82 blood flow through the lateral branching arteries.

A main body port 76, as shown in Figure 4, located at the rear end of the proximal loop portion 36a is in fluid communication with a guidewire lumen 44 extending through a central lumen 138 (see Figures 6A and 6B) within intermediate element 40. Guidewire lumen 44 provides passage and translation of a primary guidewire 48 which is used to direct and guide distal portion 32 of the system to a target implant site within the vasculature as well as to facilitate positioning and positioning. implant of the distal end of the primary lumen of the implantable device. The main body port 76 has a Luer socket similar to the Luer socket 110 described above with respect to the side branch catheter control hubs.

As further illustrated in Figure 4, a lever mechanism 56 extending distally and downwardly of the proximal loop portion 36a is provided for directing the distal catheter portion 32 of device 30 through the vasculature in which it is positioned. This lever may be replaced by a rotary control knob 193 in another handle embodiment 194 shown in Figure 9. A pull wire, cord, or steering filament (not shown) is attached to the proximal end of lever 56 and extends through the portion of catheter 32 where its distal end terminates and is joined within the nozzle cone 46 of the member. internal 42. The lever 56 is pivotally coupled within the handle portion 36a such that when rotated in a downward direction (indicated by arrow 65a of Figure 4), the steering pull wire is in a relaxed state. or loose. On the other hand, when lever 56 is turned upwards (indicated by

51/82 by arrow 65b), the steering pull wire is pulled or tensioned, thereby causing the distal end of the inner member 42 and thereby the distal end of the device 30 to be bent. Any number of steering traction wires may be employed and selectively tensioned to selectively pivot the distal end of the device 30 in multiple orthogonal directions to the longitudinal axis of the implant system. Typically, the delivery and delivery system in question will have at least one, and often two to four distal points of articulation. These pivot points may be one or more distances from the distal end of the catheter 32 to create composite curves of the distal end of the catheter.

The relative positioning and interface of the implantable device with the various catheters, lumens, guide wires, ports, and pull wires of the implant system in question will now be described with respect to Figures 5A-6c, 6A, and 6B. Figures 5A-5c illustrate an implantable device 120 partially distributed from the distal end 118 of the outer sheath 38. The implantable device 120 includes a main tubular body 122 and may include one or more side tubular branches 124. At the distal ends of the crowns or apexes 126 of the main body 122 and the side branching crowns or apexes 124 may be the eyelet loops 130 to receive the lanyards 132 (shown in Figure 5C only). As shown in Figure 5C, when operatively charged within the system 30 of Figure 2A, the main lumen 122 of device 120 is disposed longitudinally between the outer sheath 38 and the inner member 42 and positioned distally from the distal end 134 of the intermediate member 40.

To load the implant device into the outer sheath 38, the handle controls are adjusted to stretch the

52/82 stent by extending the distal tip 46 of the inner member 42 relative to the distal end of the intermediate member. When the proximal and distal loop portions 36a and 36b are extended from one another, shown in Figure 8D, the main lumen of the stent is in a stretched or tensioned condition. On the other hand, when the proximal and distal loop portions 36a and 36b are unstretched, as shown in Figure 8E, the main lumen of the stent is in the unstretched or unstressed condition. The distal lumen ends of the inner member 42 and the intermediate member 40 are the connection points for the cord or cords that are releasably joined to the main lumen openings of the distal and proximal stent 122. As discussed above, the distal luminal end of the lateral branching stent is releasably attached to the distal end of the lateral branching catheter.

Figure 6A shows a cross section of a distal portion of the implant system along lines AA of Figure 5C, and specifically the cross-sectional view is taken at the distal end of intermediate member 40. This view shows the nested relationship between the outer member 38, the intermediate member 40, the inner member 42 which is positioned within the center lumen 138 of the intermediate member 40 and the main guidewire 48 positioned within a central guidewire lumen. 44 of the inner element 40 extending distally through the tip 46.

The inner member 42 is a very small diameter catheter, for example, in the range of 3 to 8 French for cardiovascular applications and has, in addition to the central guidewire lumen 44, a plurality of fixation cord lumens 140 disposed circumferentially over the central guidewire lumen 44 which directs the alignment of the securing strands to the connection points at the distal end of the

53/82 lumen of main stent. Multiple lumens 140 are located at the distal portion of member 42 and extend over the entire length of inner member 42. Lumens 140 may be in communication with one or more blasting ports 5 in the handle portion of the delivery system whereby the saline may be blown through the lumens 140 at a pressure greater than that of the surrounding blood flow. to prevent blood flow through the lumens of the device. Lumens 140 may also be used to apply the radiopaque contrast dye used during fluoroscopic visualization of the device. Lumens 140 and outlet ports 186, described below, allow visualization of the contrast flowing through the implant at various stages of delivery to verify that stent placement results in a satisfactory flow pattern and therapeutic outcome. .

In other embodiments, such as those illustrated in Figures 10A, 10B and 10C, the fixture cord lumens 20 140 may extend only over a portion of the length of the inner member 40, for example, only a few millimeters distally to proximally. . This embodiment is particularly suitable in the case where only one attachment cord is employed with multiple stent connection points. Here, the single strand member exits one of the distal lumens, passes through the stent connection point, passes distal to proximally through another lumen, exits proximally from that lumen and passes through another distal to proximal lumen, and passes through another stent connection point. The interlacing pattern continues until all stent connection points are tied with the single strand passing through the multiple circumferential lumens. This configuration of the clamping cord lumens

54/82 extending only a portion of the length of the inner member may also be employed with the intermediate member 40 and the side branching catheters 94a, 94b, 94c. With respect to an intermediate member employing such a bead lumen configuration, the proximal portion of the intermediate member 40 should be a single lumen containing the inner member 42 and the shorter circumferential lumens containing the side branch catheters as well as the wires. fixation to the proximal end of the main stent lumen. As will be seen from this embodiment and those discussed below, any combination of loop patterns may be used to attach an individual stent end to the respective catheter to which it is attached.

Referring again to the embodiment of Figure 6A, the lumen number of the anchor strings 140 is twice the number of anchor strings 132 where a pair of adjacent anchor strand lumens 140a, 140b is provided for each distal anchor strand. 132. Thus, where device 120 is fully loaded into the delivery system, the first portion of a distal attachment cord 132 resides within lumen 140a and a second portion or return portion of the distal attachment cord resides within lumen 140b.

In addition to the clamping / distributing cord lumens 140, there are one or more lumens of the steering pull 142, whose function is as described above with respect to Figure 4. Typically, one or two pairs (180 ° apart) of wires diametrically opposed steering traction shafts are employed to provide opposite orthogonal deflections of the distal end of the delivery system. The greater the number of steering pull-wire pairs employed, the greater

55/82 articulate the application system.

In addition to the central lumen 138 through which the inner element 42 is translated, the intermediate element includes a plurality of pairs of the proximal attachment cord lumen 146a, 146b where the lumen 146a is shown radially outwardly of the lumen 146b. Attachment cords attached or threaded through the proximal crowns (not

<td rowspan="2">shown) the lumens</td><td colspan="3">from the main lumen</td><td colspan="5">122 of device 120 use</td>

<td> 146. 0</td><td>number</td><td>in</td><td>lumens</td><td>&gt; do</td><td>cord</td><td>in</td><td>fixation</td>

<td>Proximal 10</td><td>146 is the</td><td>double</td><td>of</td><td>number</td><td>in</td><td>cords</td><td>in</td><td>fixation</td>

where a pair of lumens of the anchor cord 146a, 146b is provided for each proximal anchor cord, that is, where device 120 is fully loaded into the delivery and delivery system, the fixed end portion of a proximal fixation cord resides within lumen 146a and the distal or return portion of the proximal fixation cord resides within lumen 146b.

In addition to the fixture cord lumens 146, the intermediate element 40 also provides a plurality of 20 lumens 148, also circumferentially disposed on the central lumen 138 and preferably interposed between the proximal fixture lumen pairs 146, where one or more lumens 148 may be employed for translating and applying a side branch catheter 150 (shown in Figure 6A without details). Side branch catheter 150 provides a lumen of central side branch guide wire 152 for the application and translation of a side branch guide wire 154. Additional lumens 148 extending from a handle blast port ( not shown) 30 may be provided for air evacuation from the application system 30. Additional lumens 148 may also permit rehydration of tissue graft covers or other covers that need to be prepared with solutions and therapeutic agents.

Potential such as pharmacological agents, stem cells or other agents. This allows the stent graft or other device to be confined to the delivery catheter in a subsequently dehydrated dry condition, sterilized and rehydrated by blasting and preparing the catheter at the time of use. All unused lumens 148 exhibit enhanced flexibility of the intermediate element, particularly where the distal end of the device is deflectable at multiple pivot points.

Figures 7A, 7B and 7C illustrate various possible embodiments of the side branch catheters suitable for use with the delivery system of the present invention. The side branch catheter 160 of Figure 7A provides a central guidewire lumen 162 and a plurality of fixation cord lumens 164 arranged circumferentially around the central lumen 162. Lumens 164 are used or occupied by the attachment strands (not shown) that are looped or threaded through the distal crowns 128 of the side branch lumen 124 of the device 120 (see Figure 20A). The lumen number of the side branch attachment cord 164 is twice the number of the side branch attachment cord, where a pair of lumens of the attachment branch cord 146a, 146b is provided for each side branch attachment cord, i.e. where device 120 is fully loaded into the implant system, the proximal portion of a side branch attachment cord resides within the lumen 164a and the distal or return portion of the side branch attachment cord resides within the lumen 164b.

The side branch catheter 170 of Figure 7B provides an outer member 172 having a central lumen 174 and an inner member 176 concentrically positioned thereon. Inner element 176 also has a central lumen 178

57/82 for translating and applying a side branch guidewire (not shown). The outer member 172 additionally provides a plurality of side branch attachment cord lumens 180, where there is a one to one correspondence between the number of side branch attachment cord lumens 180 and the number of branch attachment cordons side (not shown). In this embodiment, the proximal portion of the side branch attachment cords resides within the space between the inner diameter of the outer member 172 and 10 the outer diameter of the inner member 176, and after being looped through the eyelets, crowns, or stem cells. distal fixation, the distal or return portion of the strands passes through the lumens 180 of the outer member 172.

In another embodiment of the side branch catheter 200, shown in Figure 7C, the side branch catheter may be composed of two single concentric lumens. A single single lumen tubing 202 defining an inner diameter and another single lumen tubing 203 defining an outer diameter has the side branch attachment strands to be contained within the space 201 between the inner diameter of the outer tubing 202 and the Outer diameter of inner pipe 203. The inner diameter of the inner tubing is used to translate a guidewire (not shown) through the side branch guidewire lumen 204 which is isolated from the tie strands as shown in Figure 7C. This lumen configuration can also be employed with the intermediate and internal elements.

Referring to Figure 6B, a cross-sectional view taken along lines BB of Figure 5C is shown, specifically through a proximal end of distal tip 46 where inner member 42 terminates. Distal tip 46 provides the distal portion of guidewire lumen 44 as well as

58/82 as the distal lumen portions 182 of the distal anchor cord lumens 140 of the inner member 42 where the plurality of distal lumen portions 182 are axially aligned and correspond one to one with the anchor cord lumens 140 of the inner element. In this way, the same pairing of the adjacent fixation cord lumens 182a, 182b is provided for each distal fixation cord 132, that is, where the fixed end portion of a distal fixation cord 132 resides within the lumen portion 182a and the releasable or return portion of the distal attachment cord resides within the lumen portion 182b. As best illustrated in Figure 6C, upon passage within the lumen portions 182a, the attachment strands 132 are passed radially outside the distal tip 46 through the proximal side ports 184. The attachment strands are then looped or threaded around the eyelets 130 or crowns or apexes 126 or through the most distal cells of the main lumen 122 and are threaded again through the designated side door 184 of the distal tip 46, whereby again enter the respective lumen portions 182 and the respective lumens of the attachment cord 140. Thus, for each pair of fixture cord lumens, there are one half of side ports 184, that is, one to one correspondence between the number of tie straps 132 and the number of side doors 184 of the distal end. Distal tip 46 also provides distal side ports 186 for easy loading of cords during implant mounting to the delivery system.

Figure 16 illustrates a delivery system of the present invention wherein only a single strand 135 is used to retain and distribute the distal end (forward-facing end) of implantable device 120. The basic components of the system are

59/82 comparable to those identified and described with respect to Figures 5A-5c, where similar numerical references refer to similar components. Similar to the manner described with respect to Figures 10A-10C above, the single clamping / dispensing cord 135 is passed through a designated lumen (not shown) within the guidewire catheter 42 and passed radially off the distal tip 46 through a proximal side door designated 184. The attachment / distribution cord 135 is then looped or threaded through each of the eyelets 130 (or through the crowns or apexes 126 or through the most distal cells of the main lumen 122) and re-threaded through another designated side port 184 of the distal end 4 6 whereby it enters the lumen of the cord again. 0 The cord extends through the system to the proximal end and can be secured, released, tensioned, pulled, tightened, etc. by a control mechanism as described above. Similarly, additional strands may be used for attachment and distribution of the other luminal ends of the implantable device, where each luminal end is controlled by a separate strand. With fewer strands, the manufacturing and operating complexity of the stent delivery system is extremely reduced. In addition, the required cross-sectional profile (ie diameter) of the system can be minimized and thus smaller vessels.

As mentioned above, the device of the systems in question is not limited to cords and other tensionable elements and may include other devices. An example of an alternative stent delivery / fixation device is provided with delivery system 400 of Figure 17. System 400 includes a distal catheter portion 402 and a proximal or delivery portion.

60/82 handle 404.

Catheter portion 402 includes outer sheath 408 which has one or more lumens therein and within which an intermediate member 410 is translatable therethrough. When operatively loaded into the application system 400, the main body of a stent 450 (shown in Figure 18A) is received between the luminal spacing between the outer sheath 408 and the intermediate member 410. The intermediate element 410 defines a lumen through which an internal element 10 (see Figure 18B) is translated and which in turn defines a lumen 424 through which the system guide wire 418 is applicable. Inner member 416 terminates in a tapered distal tip 420 which facilitates forward translation of the device through the tortuous vasculature. Extension members 15 extend from a proximal surface of tapered tip 420, such as pins or hooks, which extend parallel to the longitudinal axis of the system. The distal end 426 of intermediate member 410 may define a receptacle or cup for receiving pins 422 to capture the apexes 428 of the distal end of main stent lumen 450 when operatively loaded therein (see Figure 18A). The proximal end 412 of the outer sheath 408 provides branching light ports 412 for receiving the side branch guide wires 425 as well as the respective 25 distribution elements (e.g. strands)

427 to direct and distribute the lateral branching lumens of a branching stent (not shown). Lanyards 427 may be controlled and tensioned by the mechanism as described above. Here, two ports 412 are provided for a 30 stent that has two side branches; however, more or less ports may be provided to accommodate stents that have any number of side branches. As for the embodiments described above, the valve mechanisms

61/82 may be provided to fluidly seal the light doors 412, thereby preventing blood from leaking therefrom.

Proximal portion 404 of delivery and delivery system 400 includes loop portion 436 which may have proximal and distal portions that are axially translatable axially relative to one another as described above to control the amount of extension and shortening by the main body of a stent operatively charged within the delivery system. Handle 436 provides a pair of controls including a knob 430 to which one end of the dispensing / fastening element (e.g., cords) for controlling the distribution of the proximal end of a stent device is permanently anchored, but is removable at all times. from the strap to manually pull the cords through it. A hemostatic valve may be incorporated into the handle to prevent backflow of fluid, for example, blood, out of the handle when the button is removed from it. Opposite control is provided by the selector or drive screw 432, which is used to releasably support the free ends of the cord or the set of strings to the handle. As described above with respect to the delivery system of Figures 2A and 2B, these control elements are used in tandem to maintain a constant tension on the attachment strands and to maintain the implant contained at its proximal end within the delivery system when the system of application is articulated through the vasculature.

<td>At</td><td>Figures 18A and</td><td>18B</td><td colspan="2">illustrate the</td><td>retention and</td>

<td>distribution,</td><td>respectively,</td><td>in</td><td>an</td><td colspan="2">distal end of</td>

<td>a lumen of</td><td>main stent</td><td> 450</td><td>of</td><td>system</td><td>400. As</td>

<td colspan="2">mentioned earlier, the</td><td colspan="2">summits</td><td>428 or</td><td>similar to</td>

stent cells at the most distal end of the stent when

62/82 are synchronized or radially held inward and are captured by coupling the pins 422 of the inner member 416 and the receptacle 426 of the intermediate member 410, as shown in Figure 18A. The coupling of the pins within the receptacle may be biased or spring loaded in such a way that when operating a release mechanism, such as by pressing a button 434 on the handle 436, the inner member 416 will advance or be thrown into the spring. forward to retract the receptacle pins 422 and release the stent apexes 428 as shown in Figure 18B. Figure 19 illustrates a spring mechanism 452 within the handle 436 which, when compressed (as is the case when the system is preloaded with the stent) holds the inner member 416 in a retracted position. When button 434 is compressed, spring 4 52 is released from its compressed condition and causes inner member 416 to advance thereby releasing pins 422 from stent apexes 428. Alternatively, the system may be configured such that intermediate element 410 may be retracted to release the pins of receptacle 426.

Any type and combination of elements and delivery mechanisms may be used with the stent delivery systems in question, where each end of the stent lumens is controlled by the same type of mechanism or one or more ends of the stent lumens may be used. be retained and released by one type of mechanism and one or more of the other ends of the stent may be retained and released by another type of mechanism.

The delivery systems of the present invention may additionally provide a device for blasting the various lumens of the system. In particular, it is important to align the guidewire lumen in order to draw air before introducing the system into the body. For this purpose, as

63/82 illustrated in Figure 17, a blasting port 438 is provided at the proximal end 442 of handle 404. Any source of blasting fluid, such as a syringe 440 shown in Figure 17, may be used to inject fluid into port 5. The blasting port 438 is in fluid communication with the guidewire lumen 424 of the inner member 416 and is thus blasted by the fluid injected therein through the port 438. Injected fluid passes through lumen 424 and forces air and is ejected out at the distal end of the lumen as shown by the arrows.

445 In subsequent stages of the procedure, blasting port 428 and lumen 424 may be used to introduce radiographic contrast to visualize blood flow through the lateral branching arteries. In order to prevent backflow of the blasting fluid and blood that may enter the system during use, gaskets or a one-way valve may be used within the system where appropriate to maintain hemostasis. For example, as illustrated in Figure 20A, a gasket 444 is employed only distally from the blasting port 438 to prevent leakage through the blasting port. Additional joints, such as joints 446 and 448, may be employed to provide hemostasis in the lumens leading to controls 430, 432.

Another optional feature of the present invention is the use of lateral branch guidewires which also function as embolic protective devices such as those used during percutaneous transluminal angioplasty (PTA), percutaneous transluminal coronary angioplasty (PTCA) and atherectomy procedures. . As shown in Figure 23, the guidewire 482 is equipped with a filter mechanism 484 that is positioned in a downstream position within the lateral branching artery prior to

64/82 lateral branch stent lumen distribution. Embolic material released as a result of lumen application or distribution is captured by filter 484.

Catheters and / or guidewires employed with the systems of the present invention may include intravenous ultrasound imaging (IVUS) capabilities wherein one or more miniaturized transducers are mounted on the tip of a catheter or guidewire to provide electronic signals to an external imaging system. Such a transducer arrangement may rotate to produce an image of the lumen of the artery showing the precise position of the extractions for the connected branch vessels that will receive the connected branch stents or other cavities into which the catheter is introduced, the vessel tissue and / or the tissue surrounding the vessel. In addition to facilitating visualization during stent delivery and delivery, such systems enhance diagnostic and treatment effectiveness by providing important diagnostic information (ie prior to stent placement), for example, the position and size of the stent. an aneurysm, which are not available from a conventional x-ray angiography. Intravenous ultrasound imaging (IVUS) catheters are generally used as a primary step in the appropriately sized stent graft selection procedure before placing a non-branching stent for a variety of reasons including ensuring that a vessel cap is covered. lateral branching is not done wrong. Combining the ability to generate images at the tip of the stenting catheter has the advantage of saving time by avoiding catheter replacement. A second technique that is generally employed to prevent exchange of the stenting catheter and IVUS catheter through the access site is obtaining. another access point for

65/82 introduce the separate IVUS catheter. By integrating IVUS transducers at the tip of the stent delivery catheter, the need for a second vascular access wound is eliminated if the imaging catheter is applied through a bilateral groin access position. In addition, when placing a stent within another stent, an IVUS catheter is used to ensure that the second stent is distributed within the lumen of the first stent in an overlapping manner to extend the length of the treated region cover. In such cases, a first stent has been placed and the downstream portion floats freely within a large aneurysm sac, and care should be taken to ensure that the second stent to be placed within the first stent does not fall outside the lumen of the first. 15 stent. Otherwise, it may result in involuntary vessel occlusion, which requires the procedure to be converted into surgery to remove the second misplaced stent.

The system components of the present invention may be alternatively or additionally provided with radiopaque markings to assist in the generation of fluoroscopic images of the components during implant placement and delivery. Figures 24A and 24B illustrate the distal end of an outer sheath 490 of a system in question where the radiopaque lines 494 were provided on the sheath wall 492. In the illustrated embodiment, two radiopaque lines 494 positioned 180Â ° from each other facilitate accurate rotational orientation of the sheath within the vasculature. These lines can also be used in conjunction with radiopaque markings provided on the stent or graft portions of the implants whereby the implant markings are aligned with those on the sheath to ensure proper implant orientation, i.e. positioning

66/82 side of the implant that has lateral branches adjacent to the side of the application sheath that will be in contact with the upper aortic arch portion. Examples of stents bearing such radiopaque markings are described in Copending U.S. Patent Application No. Prosecutor Document. DUKEPZ01101.

The external application sheaths employed with the delivery and delivery systems of the present invention may be provided separately from the remainder of the delivery catheters and may be configured to be positioned over the catheter lumen assembly. This can facilitate loading of the stent, delivery cords and guidewires. Thus, and as illustrated in Figure 25, the proximal end 504 of sheath 500 may be equipped with a hemostasis valve mechanism to prevent leakage. Another optional feature of the sheath is that it can be fabricated with a reinforced braid 506 fitted within the sheath wall 502, which makes it very resistant to high twist capability. In addition, by providing multiple spaced weld joints 508 with the braid along the length of the sheath, the translational loads and rotational loads placed on the sheath during application are more evenly distributed over the sheath length, further preventing twisting or bending of the sheath. sheath.

DEVICE IMPLANT METHODS

An implant procedure for some of the devices in question will now be described with respect to Figures 8A-8H and in the context of an aortic arch application wherein a stent graft 2 of the present invention, such as that illustrated in Figure IA, which has a main body lumen 4 and three lateral branching lumens 6a, 6b and 6c are implanted percutaneously into the aortic arch 5, where,

At implantation, the lumen of the main body 4 will reside within the aortic arch 5 and the three lateral branching lumens 6a, 6b and 6c will reside in the innominate artery 7a, the left common carotid artery 7b and the 5 subclavian artery. left 7c respectively as illustrated in Figure 8H.

By means of a Seldinger technique through the left femoral artery 8 or abdominal aortatomy, a main or aortic guidewire 48 advances through the aortic arch vasculature 5 until the distal tip 48a crosses the aortic valve 10, as shown in Figure 8A. The catheter portion 32 of the implant system 30 of the present invention, provided with the stent graft 2 operatively loaded thereon, is then percutaneously inserted into the patient's body over the guidewire 48.

It may be noted that stent grafts or stents covered with a material, for example an ECM, may require reconstitution or hydration of the graft or sheath prior to initiating the implant procedure. This can be accomplished by blasting the lead catheter lumen of the saline delivery system prior to introducing the catheter into the body. Alternatively, this could be done by open air rinsing before coating.

Although the stent graft 2 is in a loaded and undistributed state within the catheter portion 32, the delivery system handle is in the retracted position, i.e. the proximal handle portion 34a and the distal handle portion 34b are. coupled together. With the handle in position

0 retracted (shown in Figures 8B and 8D), the inner element is held in a distally advanced position and the intermediate element 40 is held in a proximally retracted position. This relative axial relationship between the elements

Intermediate and internal 68/82 maintains stent graft 2 or at least

<td>any less</td><td>your lumen</td><td colspan="3">main 4 in</td><td>an</td><td>stretched condition</td><td>or</td>

<td colspan="2">tensioned. This</td><td>is</td><td>done</td><td>so</td><td>what</td><td>the distal crowns</td><td>of</td>

<td>lumen</td><td>main</td><td> 4</td><td>if already</td><td>united</td><td colspan="2">to the distal end</td><td>of</td>

<td colspan="2">5 inner element</td><td> 42,</td><td>what</td><td>is fixed</td><td>per</td><td>turn to portion</td><td>in</td>

the proximal loop 34a and the proximal crowns of the main lumen 4 are joined to the distal end of the intermediate member 40, which is in turn attached to the distal loop portion 36b.

The portion of the catheter 32 is then directed as required by the manipulation lever 56, thereby deflecting to the tip of the distal catheter 32 as described above with respect to Figure 4, and advancing to the descending aorta and then to the aortic arch 5. . It is important that the catheter portion is correctly rotatably positioned so that the side branching lumens 6a, 6b and 6c of stent graft 2 are substantially aligned with the arteries 7a, 7b and 7c, respectively, to which they should be applied. . For this purpose, catheter 32 may be twisted and fluoroscopic orientation may be employed to further facilitate application of the catheter portion 32. In particular, fluoroscopic markers (not shown) on the crowns of stent graft lumens can be accurately tracked and positioned for more favorable placement within the respective arteries. The stent itself may be radiopaque. The tip of the catheter will also be radiopaque. A steerable guidewire can be used to guide the main catheter 32 and side branching catheters as the stretched main stent body and side branching stent bodies are guided by the deflectable tip guide wires placed at the target implant site. .

During any application and delivery procedure, the various lumens of catheter portion 32 may be

They may be continuously blasted with a fluid, for example, saline or contrast agent, in a retrograde direction (relative to blood flow) at a pressure that is greater than or substantially equal to arterial blood pressure. This prevents possible blood leakage from the system as well as any interference with the operation of the application process, keeping the lumens of the stent strands particularly free and bloodless, thereby eliminating clots within the lumens. In addition, since each luminal end of the stent graft (i.e., the proximal and distal ends of the main lumen 4 as well as the distal ends of the lateral branching lumens) is individually controlled (however, some or all may be controlled by the delivery and delivery system 30 of the present invention, the interconnected stent cells can be selectively elongated axially in one direction, allowing a continuous blood flow around the device during delivery within the anatomy. This axial elongation feature also allows for the implantation of larger diameter side branch stents into a vessel having a smaller diameter.

Since the distal end of the catheter portion 32 is operatively positioned within the aortic arch 25, the outer sheath 38 is manually retracted by pulling on socket 50 (see Figure 3A) to expose the proximal end of the nozzle cone 46 of the catheter. inner member 42 and to partially distribute the distal portion of the main or aortic lumen 4 of stent graft 2 within the ascending aorta 30, as shown in Figure 8C. With partial distribution of stent graft 2, ie the main aortic lumen 4 is maintained in a stretched or tensioned state, the arterial blood flow leaving the valve

Aortic 10 flows through and around the main lumen 4. It is important to note that with the main lumen 4 in this partially distributed state, stent graft 2 can be easily repositioned within the vasculature because 5 is not yet coupled with the vessel walls and thus is not subject to the frictional resistance that contact with the walls should cause, in addition to preventing the resulting endothelial damage and / or plaque embolization that may occur.

Although several side branch lumens 6a, 6b and 6c of stent graft 4 may be distributed serially (one at a time) in any order or parallel (simultaneously) together, it may be easier to distribute side branch stent lumens one by one. each time from the 15 most distally positioned stent lumen (6a) to the most proximally positioned stent lumen (6a). This order of distribution eliminates unnecessary or repetitive translation of the outer sheath 38 over the stent graft, that is, only gradual, unidirectional (proximal) translation is required.

This is advantageous in that abrasions to the graft material are minimized, which is particularly important when coated with a material, for example extracellular matrix or a drug. This order of distribution also reduces the required distribution steps and thus the total time required for the implant procedure.

To distribute a side branch stent lumen, such as stent lumen 6a, a side branch guide wire 154 is inserted (or may be preloaded) into the side branch port 110 of the respective control hub in its distally position. and a forward lumen 152 of the side branch catheter 150 positioned within the lumen 148 of intermediate member 40 (see Figure 6A). At the same time, the outer sheath 38 is

Retracted incrementally and gradually proximally to allow the distal end of the guidewire 154 to be translated through the lateral branching catheter 150 out of its distal end and into the innominate artery 7a as shown in Figure 8C. The respective control hub is then translated distally along the intermediate element 40 and can be fully coupled with the associated catheter hub 84, thereby exerting the maximum tension being applied to the side branch 10 stent cells by the attachment strands. joined and partially depositing the side branch stent 6a as shown in 8D. It should be noted that the main body stent cells are held distal to proximally stretched through the relative positions of the inner element and the intermediate element, as controlled by the handle in the near configuration, with a side branch stent being maintained in the same manner. in a position stretched by the distally advanced lateral branching catheter. This procedure is repeated as necessary for the remaining number of lateral branch stents, in this case the lateral branch stents 6b and 6c that are applied to the left common carotid artery 7b and the left subclavian artery 7c, respectively, as illustrated in Figure 8D. It should be noted that, in this partially distributed state, blood flow is around the device as well as through the implant, depending on how firm and over what length of the extension cords are pulled into the exit ports of the inner element. 184 It may be desirable to have a slack flow around the device rather than through the lumen of the device and can be accomplished by tightening down the fastening strands at the distal end of the main lumen to allow the minimum fixture length bring this

Thus, the main lumen of the stent graft to be kept closed against the distal tip 46 or the inner member 42. It is important to note that the distance between the end of the distal main stent and its connection to the inner element is controllable by the stent graft. length of the distal fixation cords that are controlled by the cord clamp 70b when adjusting and selecting the position from which the clamp is locked on the distal fixation cords. This adjustment can be made in situ while the stent is applied. Likewise, the distance between the end of the proximal main stent and its connection to the intermediate element is controllable by the length of the proximal attachment strands that are controlled by the cord clamp 72b by adjusting and selecting the position from which the clamp is locked. in the proximal fixation cords.

This adjustment can be made in situ while the stent is applied.

After placement within the branching arteries of all lateral branching stents in their partially distributed states, the stent graft is ready 20 for complete delivery. This is accomplished by moving the system handle to the extended position, that is, the proximal handle portion 34a and distal handle portion 34b are axially separated from each other as illustrated in Figure 8E.

This action causes the inner element 42 to be moved proximally to the fixed intermediate element 40 and in turn relaxes the tension applied to the cells of the main lumen 4, thereby bringing the ends of the lumen closer together.

Thus, the stent is shortened and there is a corresponding increase in the diameter of the main lumen 4, thereby fixing the main lumen 4 against the aortic walls.

Side branch catheters are similarly translated proximally by moving the respective control hub 74, 76, 78 to a distance

73/82 of its corresponding catheter hub 84, 86, 88, thereby relaxing the tension applied to the side branch stent cells. Thus, there is a corresponding increase in the diameter of the side branch lumens 6a, 6b, 6c once the luminal ends are shortened. It is important to note that the distance between the stent ends and the catheter end is controllable by adjusting the length⁸ of the strands that cross between the fixed end knob

70a, 72a, 74a, 76a, 78a and the releasable end clamp 70b, 72b, 74b, 76b, 78b.

Once the stent cells have been released from their tension by translating the catheter loop and side branch catheters, and while the stent opens to a diameter that is expanded against the surrounding artery wall, the entire blood flow enters through the distal end of the device and exits all of its other lumens. Preferably, blood flow is sealed around the outside of the stent graft once the stent has been completely distributed.

Although the stent itself may be fully distributed as shown in Figure 8E, it is still joined by the clamping strings assemblies to each of the distal ends of the inner member 42, the intermediate member 40, and each side branch catheter.

150a, 150b, 150c. The lumen ends of the stent graft can now be detached from their respective. catheters. The luminal graft stent ends can be released serially (one at a time) in any order or parallel (simultaneously) together. As shown in

Figure 8F, the lumen ends of the side branch lumens 6b and 6c have been released, with the respective attachment cords 190, side branch catheters 150a, 150b, 150c and side branch guide wires 154 having

74/82 been retracted. For each side branch luminal end, as illustrated for side branch lumen 6a, catheter removal is performed by actuating the designated control cuff 74b, 7,6b and 78b on its respective catheter hub 74, 76, 78 to release the free ends of the catheter hub screw clamp strings 190 while removing the control knob 74a, 76a, 78a of the loop and pull the cords 190 to the point where the free ends dislocate or detach from the crowns of the respective stents 128 of Figure 8F.

The cords 190 need only be pulled until their free ends release the crowns, but can be pulled from the distal end of the catheter portion 32.

As illustrated in Figure 8G, a similar procedure is performed with respect to the distribution of the distal and proximal ends of the main lumen 4, where each end may be distributed first or both ends may be distributed simultaneously. The designated control clamp 70b, 72b is actuated to release the free ends of the strands 192 and at the same time the control buttons 70a, 72a are removed from the handle thereby pulling the strands 192 to the point where the free ends detach or detach from the crowns of the respective stents 126. The cords 192 need only be pulled until their free ends release the crowns, but may be extracted from the distal end of the catheter portion 32. The entire portion of catheter 32 can then be removed from the vasculature with stent graft 2 in a completely distributed state within aortic arch 30, as shown in Figure 8H.

Referring now to Figure 11, the partial distribution step of the procedure described above is illustrated with respect to the application and distribution of the

75/82 implant 210 of Figure 1E. Specifically, the catheter portion 38 of the delivery system is positioned within the aorta with the distal portion of the main stent lumen 122 partially distributed within the aortic root and ascending aorta 5, and the lateral branching lumens 214a and &lt;. 214b partially distributed within the right and left coronary ostia 220 and 222, respectively. A guide wire⁴ 218 extends from catheter 38 and crosses the anterior position of natural aortic valve 224, with lateral branching guide wires 226 and 228 extending within the coronary ostium 220, 222 of lateral branching catheters 230 and 232, respectively. Upon release of the fixation cords into the main lumen of the implant, the prosthetic aortic valve 216 will reside within the natural annulus 15 224. Side branch lumens 214a, 214b may be distributed simultaneously with each other and with the main lumen 212 or in series in any order.

In any surgical or endovascular procedure as described herein, the fewer incisions made on the patient, the better. Of course, this often requires highly specialized instrumentation and tools used by a highly skilled surgeon or physician. In view of this, the single-incision device implantation procedure described above may be modified to include the creation and use of one or more secondary incisions to facilitate the initial application of the catheter portion 38 of delivery system 32 to the implant site. implant and to further ensure proper stent graft orientation when delivered to the site.

The two-incision (or multiple-incision) procedure of the present invention involves a primary incision, for example, a downward cut in the femoral artery as

76/82 described above, whereby the delivery and delivery system described above is introduced into a first vessel within the body, for example, into the aortic arch, and a second incision (or more) at a location providing access to At least one vessel crossing the first vessel, for example, is one of the lateral branches of the aortic arch. This procedure is now described with reference to Figures 12A.^v 12F and in the context of stent 2 graft implantation of the present invention in the aortic arch by the use of a primary incision 10 made in the left femoral artery 8 to reach the aortic arch 5 and a single secondary incision made in the brachiocephalic or radial artery 15 to reach one or more arteries of the aortic tree.

The first and second access incisions are made in the left femoral artery 8 and the left brachiocephalic artery 15, respectively. By a Seldinger technique, a secondary or mooring guidewire 300 advances through the left brachiocephalic artery 15 to the innominate artery 7. Guidewire 300 then advances further to the aortic arch 5, to the descending aorta

11, the abdominal aorta 13 and the left femoral artery 8 where it exits the body through the femoral incision, as shown in Figure 12A. A secondary or mooring catheter 302 then runs over the femoral end 300a of the guidewire 300 and along the length of the guidewire until catheter 302 advances out of the brachial incision, as illustrated in

Figure 12B. Any ready-to-use system suitable for cardiovascular applications may be employed for use as a guide wire and secondary or mooring catheter.

0 A fast-changing double lumen (RX) catheter, as illustrated, has a second lumen positioned at the proximal end of catheter 302. One advantage of an RX catheter is that it only requires a cord (or a

77/82 guide wire) is pushed a relatively short distance (which requires little pushing) before leaving the lumen rather than a longer distance at which it would be difficult to push the cord because of its weak nature.

Alternatively, the catheter end 302 itself may be provided with a through hole or a transverse hole in the catheter wall, as illustrated in Figure 12C.

The implant system 30 described above is then provided with the stent graft 2 operatively loaded therein. For this procedure, as shown in Figure 12C, the side branch attachment strings 190 or at least one strand for the distribution of the more distally located side branch stent lumen 6a (i.e. which are intended for implantation in the innominate artery 7a) and attached to it (to one or more stent crowns) are extended from the side branch catheter 150a of the primary catheter or stent delivery system 38 and then threaded through a side branch mooring tubing 35. The cords are then tied 37a to prevent proximal removal 20 back to catheter 150a and tubing 35. The remaining distal length of the cords 190 is then threaded through the exchange lumen 304 of the lashing catheter 302. The ends of the cords are then tied a second time 37b to prevent proximal removal of the exchange lumen cords 304. With this embodiment from the secondary catheter of Figure 12C, the cords are threaded into the main lumen 302 and out of the side bore 305. The distal ends of the cord are then tied 37b.

Secondary catheter 302, together with side-branching catheter 30a, such as the entire stent catheter 38 including primary or primary guidewire 48, then advances again through the femoral incision through secondary guidewire 300 to that the catheter

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302 is completely removed from the brachial incision, as illustrated in Figure 12D, and until the distal end of the side branch catheter 150a is also extended from the brachial incision. The lashing guide wire 300 can now be removed from the body. At this time, the cords 190 are cut at a position 307 between the distal end of the side branch catheter 150a and the opposite end of the secondary catheter 302 to release the mooring catheter 302 from the stent delivery system.

By the tension applied to the cords 190 and their translation, the lateral branch 6a of the stent graft 4 is extracted to the innominate artery 7a, as illustrated in Figure 12E, in a partially distributed (i.e. exposed but stretched) state. Simultaneously, the stent guidewire 48 advances over the aortic arch 5 and through the aortic valve 10, thereby advancing the nozzle cone 46 and thereby the distal (i.e. exposed but stretched or tensioned) end of the lumen. partially distributed main stent 4 in the ascending aorta. Meanwhile, the stent catheter 38 follows over the guide wire of stent 48 to the aortic arch 5. Continued forward advancement of stent catheter 38 is obstructed by partially distributed lateral branch lumen 6a.

As discussed above, with the main lumen 4 held in a stretched or tensioned state (as well as the lateral branching lumen 6a), several advantages are obtained: arterial blood flow from the aortic valve 10 flows to the brain and body; Repositioning of the stent graft is possible and the likelihood of endothelial damage and / or aortic wall plaque embolization is greatly minimized.

For stents and stent grafts that have two or more lateral branching lumens 6a, 6b, 6c, as in Figure 12F, the procedure described above and illustrated in

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Figures 12A-12E with respect to implantation of a stent having a single lateral branching lumen is performed simultaneously, with the designated mooring guidewires and separate catheters 150a, 150b, 150c. As shown in Figure 12F, at least with the distal end of the main stent lumen 4 precisely positioned and partially distributed within the ascending aorta, the respective lateral branching lumens 6a, 6b, 6c are distributed within the innominate artery 7a of the carotid artery. common left

7b and the left subclavian artery

7c, respectively. Alternatively, one or more side branch lumens may be partially distributed as described with respect to Figures 12A-12F and the remaining side branch lumens, if any, may be distributed as described above with respect to

Figures 8C and 8D. Finally, with all side branch lumens 6a, 6b, 6c partially distributed within their respective arteries, the procedural steps described with respect to Figures 8E-8H can be performed to completely distribute all stent graft lumens and to remove the body application system.

Although the implants of the present invention have been described as being distributable by the elements or mechanisms containing the stent, it should be understood that the implants in question may be configured such that they and / or their lumen ends are configured for delivery. by an element or expandable elements. For example, each end of the implant (i.e. the main lumen and side branch lumen (s)), in an undistributed charged state, may be coupled to one or more of the catheters nested by the implant. placement over an expandable balloon attached to the catheter (s). Balloons, either partially or completely

80/82 expanded, offer a sufficiently comfortable fit with the ends of the implant such that the implant lumens can be selectively stretched or tensioned along their lengths when manipulating catheter components.

What has been seen above merely illustrates the principles of the invention. It should be appreciated that elements of skill in the art devise various arrangements which, although not explicitly described or shown in the present invention, incorporate the principles of the invention and are included within their character and scope. In addition, all examples and conditional language cited in the present invention are primarily intended to assist the reader in understanding the principles of the invention and the concepts contributed by the authors of the present invention to further the art, and should be construed as not limited to such examples and conditions specifically cited. Furthermore, all statements which cite the principles, aspects and embodiments of the invention, as well as specific examples thereof, are intended to encompass structural and functional equivalents thereof.

Furthermore, such equivalents are intended to include currently known equivalents and future developed equivalents, that is, any developed elements that perform the same function, regardless of structure. The scope of the present invention, therefore, should not be limited by the exemplary embodiments shown and described in the present invention. Instead, the scope and character of the present invention are embodied by the appended claims.

It should be noted that as used in the present invention and the appended claims, the singular forms one, one, and the, the, include plural referents, unless the context clearly dictates otherwise.

81/82 another way. Thus, for example, reference to a cord may include a plurality of such cords and reference to a tubular element includes reference to one or more tubular elements and equivalents known to them by those skilled in the art, and so forth. .

Where a range of values ​​is provided, it must be understood that each intervention value, to the tenth of the lower bound unit, unless the context clearly dictates 10 otherwise, between the upper and lower bounds of that range, is also specifically described. Each smaller range between any indicated value or intervention value in a given range and any other indicated value or intervention in that indicated range is within the scope of the invention. The upper and lower limits of these minor ranges may be independently included or excluded in the range and each range where neither or both limits are included in the minor ranges is also within the scope of the invention, subject to any specifically excluded limit within the indicated range. Where the indicated range includes one or both limits, ranges excluding either or both included limits are also included in the invention.

All publications mentioned in the present invention are incorporated herein by reference to describe and disclose the methods and / or materials for which the publications are cited. The publications discussed in the present invention are provided for their description only prior to the filing date of this patent application. Nothing herein is to be construed as an admission 30 that the present invention is not intended to anticipate such publication by virtue of the preceding invention. Also, actual publication dates that may need to be provided publication dates may differ from

Independently confirmed.