# Patent

## Title
Delivery system and method for bifurcated graft

## Abstract

A delivery system and method for delivering a bifurcated intracorporeal device. The delivery system comprises a shaft having a distal section supporting a primary support member positioned to be disposed within at least a primary portion of the bifurcated intracorporeal device and a secondary support member extending within a secondary portion of the bifurcated intracorporeal device. At least one belt is configured to be circumferentially disposed about a portion of the secondary support member so to at least partially constrain the secondary portion of the bifurcated intracorporeal device. A tube defining a lumen is secured relative to the secondary support member. A release member is configured to engage and releasably secure the belt in a constraining configuration. The release member extends through at least a portion of the tube lumen such that the release member is accessible adjacent a proximal end of the tube.

## Background
BACKGROUND OF THE INVENTION
The present invention relates generally to a system and method for the treatment of disorders of the vasculature. More specifically, a system and method for treatment of an abdominal aortic aneurysm and the like, which is a condition manifested by expansion and weakening of the aorta. Prior methods of treating aneurysms have consisted of invasive surgical methods with graft placement within the affected vessel as a reinforcing member of the artery. However, such a procedure requires a surgical cut down to access the vessel, which in turn can result in a catastrophic rupture of the aneurysm due to the decreased external pressure from the surrounding organs and tissues, which are moved during the procedure to gain access to the vessel. Accordingly, surgical procedures can have a high mortality rate due to the possibility of the rupture discussed above in addition to other factors. Other risk factors for surgical treatment of aortic aneurysms can include poor physical condition of the patient due to blood loss, anuria, and low blood pressure associated with the aortic abdominal aneurysm.
Due to the inherent risks and complexities of surgical intervention, various attempts have been made to develop alternative methods for deployment of grafts within aortic aneurysms. One such method is the non-invasive technique of percutaneous delivery by a catheter-based system.
U.S. Patent Application Publication No. US 2004/0138734, which is incorporated herein in its entirety by reference, describes systems and methods for the delivery of endovascular grafts, including bifurcated grafts. FIG. 1 illustrates a delivery system 10 of such publication for delivery and deployment of a bifurcated intracorporeal device 12 within a patient's body. The delivery system 10 includes an elongate shaft 14 having a proximal section and a distal section. The bifurcated intracorporeal device 12 is disposed on the distal section of the elongate shaft 14. The distal section of the elongate shaft 14 also includes an elongate primary belt support member 16 and at least one primary belt 18 secured to the primary belt support member 16. The primary belt 18 is configured to be circumferentially disposed about a primary portion 15 of the bifurcated intracorporeal device 12 to constrain such portion 15 of the device 12. A primary release member 20 engages and releasably secures the primary belt 18 in the constraining configuration. The distal section of the elongate shaft 14 also includes at least one elongate secondary belt support member 22 disposed adjacent the elongate primary belt support member 16. At least one secondary belt 24 is secured to the secondary belt support member 22 and is configured to be circumferentially disposed about a secondary leg portion 23 of the bifurcated intracorporeal device 12 to constrain such portion 23 of the device 12. A secondary release member 26 engages and releasably secures the secondary belt 24 in a constraining configuration.
The distal end of the delivery system 10 is introduced into the patient's body and advanced to a desired site within the patient's body. The delivery system 10 generally delivers the bifurcated intracorporeal device 12 via a single patient lumen or vessel, for example, either the left or right iliac (or femoral) artery. After the delivery system has been positioned above the carina of the iliac artery bifurcation, the secondary belt support member 22, and thereby the secondary leg portion 23, is moved laterally to align with the other of the iliac arteries. To facilitate such, a release strand 28, comprising first and second strands 27 and 29, is looped through a proximal portion of the secondary support member 22. The distal ends of the strands 27 and 29 are interconnected at an actuator hub 30 while the opposed proximal ends of strands 27 and 29 are directed out a secondary opening from the other of the iliac (femoral) arteries. As shown in FIG. 1, the secondary release member 26 is also attached to the actuator hub 30. When both strands 27 and 29 are pulled equally, they can be utilized to pull the secondary support member 22, but they do not cause any relative movement to the secondary release member 26 since the strands 27 and 29 apply an equal force to the actuator hub 30. To release the secondary belt 24, strand 29 is pulled proximally such that the actuator hub 30, and thereby the secondary release member 26, will be pulled proximally until the secondary release member releases the secondary belt 24.
To assist in directing of the strands 27 and 29 of the release strand 28 toward the secondary opening in the other of the arteries, the release strand 28 may initially be covered by a tube 32 or sheath or the like. During initial delivery of the delivery system 10, the tube 32 may either be fished, directed along a guide wire, or otherwise directed through the secondary opening. After the tube 32 is directed through the secondary opening, the tube 32 is removed from the release strand 28 such that both strands 27 and 29 are exposed.
SUMMARY OF THE INVENTION
In one aspect, the present invention may provide a delivery system for a bifurcated or modular intracorporeal device. The delivery system comprises a shaft having a distal section supporting a primary support member positioned to be disposed within at least a primary portion of the bifurcated or modular intracorporeal device and a secondary support member disposed adjacent the primary support member and extending within a secondary portion of the bifurcated or modular intracorporeal device. At least one belt is configured to be circumferentially disposed about a portion of the secondary support member so to at least partially constrain the secondary portion of the bifurcated or modular intracorporeal device. A tube defining a lumen is secured relative to the secondary support member. A release member is configured to engage and releasably secure the belt in a constraining configuration. The release member extends through at least a portion of the tube lumen such that the release member is accessible adjacent a proximal end of the tube.
In another aspect, the invention may provide a method of delivering a bifurcated or modular graft having a main body portion, an ipsilateral leg and a contralateral leg. The method comprises positioning a distal end of a shaft into a target vessel through a first access hole with the distal end of the shaft supporting a primary support member disposed within the main body portion and ipsilateral leg and a secondary support member disposed adjacent the contralateral leg; extending a proximal end of a tube out through a second access hole, a distal end of the tube secured relative to the secondary support member, the tube defining a lumen extending therein; releasing a primary belt configured to be circumferentially disposed about the primary support member to constrain at least a portion of the main body by proximally displacing a primary release member through the first access hole; accessing, through the tube lumen at the proximal end of the tube, a secondary release member configured to engage and releasably secure a secondary belt in a constraining configuration about the contralateral leg to constrain at least a portion thereof; and releasing the secondary belt by proximally displacing the primary release member.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a magnified view of the abdominal aorta area of the patient with a prior art bifurcated endovascular stent graft delivery system illustrated therein.
FIG. 2 is an elevational view in partial section of an embodiment of a delivery system in accordance with one or more aspects of the invention.
FIG. 3 is a perspective view of the belt support member assembly at a distal portion of the delivery system of FIG. 2.
FIG. 3A is a cross-sectional view along the line 3A-3A in FIG. 3.
FIG. 3B is a cross-sectional view along the line 3B-3B in FIG. 3.
FIG. 3C is a cross-sectional view similar to FIG. 3B illustrating the access opening with the cover removed.
FIGS. 4 and 6-8 are perspective views of alternate embodiments of the distal end of the release strand tube of the present invention.
FIG. 5 is a cross-sectional view along the line 5-5 in FIG. 4.
FIGS. 9-13 are perspective views of alternate embodiments of the proximal end of the release strand tube of the present invention.
FIG. 14 is a perspective view of the proximal end of the release strand tube of FIG. 13 illustrating the end being separated to facilitate pulling of the secondary release wire.
FIG. 15 illustrates a portion of the internal vasculature of a patient, including the aorta, iliac and femoral arteries branching therefrom.
FIG. 16 is a magnified view of the abdominal aorta area of the patient shown in FIG. 15 and shows a guidewire positioned in the aorta from the right iliac artery.
FIGS. 17-28 illustrate the magnified view of the abdominal aorta of the patient shown in FIG. 15 and depict a deployment sequence of a bifurcated endovascular stent graft with the delivery system of FIG. 2.
FIG. 29 is a side elevation view of the secondary delivery structure in accordance with one or more aspects of the invention.
FIGS. 30-32 continue to illustrate a deployment sequence of the bifurcated endovascular stent graft delivery system of FIG. 2.



DETAILED DESCRIPTION OF THE INVENTION
Although the invention is illustrated and described herein with reference to specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention.
As used herein, the proximal end of the elongate shaft is the end proximal to an operator of the delivery system 410 during use. The distal end of the elongate shaft is the end that enters and extends into the patient's body. The proximal and distal directions for the delivery system and endovascular graft loaded within the delivery system as used herein are the same. This convention is used throughout the specification for the purposes of clarity, although other conventions are commonly used. For example, another useful convention defines the proximal end of an endovascular graft as that end of the graft that is proximal to the source of blood flow going into the graft.
FIGS. 2 and 3 illustrate a delivery system 400, for delivering an expandable intracorporeal device in the form of a bifurcated stent-graft 401, that is a first embodiment of the present invention. The illustrated graft 401 is shown as an example, but the present invention is not limited to use with such grafts and can be utilized with various grafts and other structures. Furthermore, while the illustrated stent-graft 401 is shown as a bifurcated graft, it may alternatively be a modular stent-graft with separate components which are attached to one another after insertion. In the illustrated embodiment, the graft 401 includes a main body portion 402 at a distal end 403 thereof that has a generally tubular cross-sectional profile when the graft takes on an expanded or deployed configuration. An ipsilateral leg 404 and a contralateral leg 405 (short leg), each having a substantially tubular configuration when expanded or deployed, branch from the main body portion 402 at bifurcation 406 and extend in a proximal direction from the bifurcation 406. The ipsilateral leg 404 terminates proximally with a proximal self-expanding member 407 and the contralateral leg 405 terminates proximally with a proximal self-expanding member 408.
A second distal self-expanding member 411 is disposed at a distal end 412 of the main body portion 402 of the graft 401 as with the graft embodiments previously discussed. Also, as with other endovascular graft embodiments discussed herein, the graft 401 may have inflatable channels and inflatable cuffs that serve, among other functions, to provide support for the graft 401 and the inflatable channels and cuffs can have configurations which are the same or similar to those inflatable channels and cuffs of other graft embodiments discussed herein, as well as other configurations. A distal inflatable cuff 413 is disposed at the distal end of the main body portion 402. Proximal inflatable cuffs 414 and 415 are disposed on the ipsilateral leg 404 and the contralateral leg 405, respectively. Inflatable channels 418 are fluid tight conduits which connect the inflatable cuffs 413, 414 and 415. The inflatable channels 418 and inflatable cuffs 413 and 414 are inflatable through an inflation port 421 that may be disposed at or near the proximal end of the ipsilateral leg 404. The inflation port 421 may alternatively be disposed at or near the proximal end 417 of the contralateral leg 405, or it may be disposed on other portions of the device as necessary. Generally, the structure and the materials used in the graft 401 (both the graft portion and the self-expanding members) can have various structures. In one particular embodiment, the main body portion and legs of the graft are made of expanded polytetrafluoroethylene (ePTFE) and the self-expanding members are made of nickel titanium, stainless steel or the like.
A first distal self-expanding member 422 is secured to the second distal self-expanding member 411 as shown in FIG. 2. The first and second distal self-expanding members 422 and 411 may be deployed in any desired sequence. In a particular embodiment having first and second distal self-expanding members, it may be desirable to first deploy the second distal self-expanding member 411 prior to deploying the first distal self-expanding member 422. Deploying the second distal self-expanding member 411 first may allow the operator to accurately adjust the axial position of the graft in the body lumen or vessel to within one to several millimeters before deploying the first distal self-expanding member 422. Using this technique, deployment of the second distal self-expanding member 411 alone provides sufficient resistance to axial displacement of the graft 401 for the graft position to be maintained in normal blood flow, but still allows deliberate axial displacement by the operator to achieve a desired axial position. This may be particularly important if tissue-penetrating members are included on the distal-most or first distal self-expanding member 422. If such tissue penetrating members are used on the first distal self-expanding member 422, axial movement may be difficult or even impossible once this member 422 is deployed without risking damage to the body lumen or vessel. As such, accurate axial placement of the graft 401 prior to deployment of the first distal self-expanding member 422 can be critical.
In addition, although not shown in the figures, this graft embodiment 401 may include two or more proximal self-expanding members disposed on one or both of the ipsilateral leg 404 and/or contralateral leg 405. These self-expanding members may have a configuration similar to that of the first and second distal self-expanding members 411 and 422
FIG. 2 shows delivery system 400 in partial section having an elongate shaft 423 with a proximal end 424, a distal end 425 and a distal section 426. A proximal adapter 427 is disposed at the proximal end 424 of the elongate shaft 423 and houses the controls that enable the operator to manipulate elements at the distal section 426 of delivery system 400 to release and deploy the graft 401, including inflating the graft channels 418 and cuffs 413, 414 and 415. The elongate shaft 423 has an inner tubular member 430 and an outer tubular member 431 disposed about the inner tubular member 430. The outer tubular member 431 is generally configured to slide in an axial direction over the inner tubular member 430. A proximal end 432 of the inner tubular member 430 is secured to or disposed on the proximal adapter 427. The inner and outer tubular members 430 and 431 may be made of polymeric materials, e.g., polyimides, polyester elastomers (HYTRELTM), or polyether block amides (PEBAXTM), and other thermoplastics and polymers. The proximal adapter 427 is generally fabricated from a polymeric material such as polyethylene, acetal resins (DELRINTM), etc., but can also be made from any other suitable material.
Bifurcated stent graft 401 is shown in FIG. 2 disposed within the distal section 426 of the elongate shaft 423 in a constrained configuration. The outer tubular member 431 is disposed about the graft 401 in the constrained state but can be retracted proximally so as to expose the constrained graft 401 by proximally retracting a proximal end 433 of the outer tubular member 431.
FIG. 2 shows the inner tubular member 430 disposed within the outer tubular member 431 and the guidewire tube 436 disposed within the inner tubular member 430. The guidewire tube 436 may be made from polymeric materials such as polyimide, polyethylene, polyetheretherketones (PEEKTM).
A release member tube in the form of a release wire tube 441 is disposed about a distal primary release member in the form of a distal primary release wire 442. The release wire tube 441 is also disposed about a proximal primary release member in the form of a proximal primary release wire 443. Both the release member tube 441 and an inflation tube 444 are disposed within an inner lumen 445 of the inner tubular member 430.
A potted portion 446 is disposed between an inner surface of a distal end of the inner tubular member 430, the release wire tube 441, the guidewire tube 436 and the inflation tube 444. The potted portion 446 seals the inner lumen 445 of the inner tubular member 430 from bodily fluids that are exposed to the constrained graft 401 and potted portion 446 once the outer tubular member 431 is proximally retracted. The potted portion 446 may be made from adhesives, thermoforming plastics, epoxy, metals, or any other suitable potting material. Alternatively, a molded or machined plug may be bonded or affixed to the distal end of the inner tubular member, with lumens to accommodate the passage of tubes 441, 436 and 444.
A distal section 451 of the guidewire tube 436 serves as a primary belt support member 452 and is disposed within the main body portion 402 and ipsilateral leg 404 of the graft 401. Alternatively, the primary belt support member 452 may be disposed adjacent the graft main body portion 402 and ipsilateral leg 404. A secondary belt support member housing 453 is secured to the primary belt support member 452. An additional length of guidewire tube or other elongate member serving as a secondary belt support member 454 is slidably disposed within an appropriately configured lumen 455 of the housing 453. The secondary belt support member 454 is shown disposed within the graft main body portion 402 and contralateral leg 405; however, the secondary belt support member 454 may also be disposed adjacent the contralateral leg 405, regardless of whether the primary belt support member 452 is disposed adjacent or within the main body portion 402 and ipsilateral leg 404.
The secondary belt support member housing lumen 455 and secondary support member 454 cross sections may be keyed, singly or in combination, to allow relative sliding motion without relative rotation motion and therefore limit any twisting of the secondary support member 454 and the contralateral leg 405. The secondary belt support member 454 may be made from alloys such as nickel titanium, stainless steel, or polymeric materials such as polyimide.
A proximal primary belt 456 is shown disposed about and radially constraining the proximal self-expanding member 407 of the ipsilateral leg 404. This proximal self-expanding member 407 in turn is disposed about a bushing 457 that is shown as cylindrical in form, but which may have other configurations as well. The bushing 457 is secured to the primary belt support member 452 adjacent the proximal self-expanding member 407 of the ipsilateral leg 404.
A first distal primary belt 458 is disposed about and radially constraining the first distal self-expanding member 422, which itself is disposed about a cylindrical bushing 461. A second distal primary belt 462 is disposed about and radially constraining the second distal self-expanding member 411 and the second distal self-expanding member 411 is disposed about a cylindrical bushing 463.
A secondary belt 464 is shown disposed about and radially constraining the proximal self-expanding member 408 of the contralateral leg 405. This proximal self-expanding member 408 is disposed about a bushing 465 that is cylindrical in shape.
The belts 456, 458, 462 and 464 are typically made from nickel titanium, an alloy that is capable of exhibiting a unique combination of high strain without elastic deformation, high strength and biocompatability. However, any other suitable materials may be used including other metallic alloys such as stainless steel, high strength fibers such as carbon, KEVLARTM, polytetrafluoroethylene (PTFE), polyimide, or the like.
A distal portion 466 of the proximal primary release wire 443 is disposed within end loops 468 of the proximal primary belt 456 so as to releasably secure the proximal self-expanding member 407 of the ipsilateral leg 404 in a constrained state. The proximal primary belt 456 may be disposed about the self-expanding member 407 in a hoop-like configuration. The proximal self-expanding member 407 exerts outward radial pressure on the releasably secured belt 456. The primary proximal release wire 443 is axially moveable within the end loops 468 of the proximal primary belt 456 to allow for release of the belt by proximal retraction of the primary proximal release wire 443 in the same manner as described above with respect to other embodiments of the present invention.
Likewise, a distal portion 471 of the distal primary release wire 442 is disposed within end loops 472 of the second distal primary belt 462 that radially constrains the second distal self-expanding member 411. The second distal primary belt 462 is formed in a hoop configuration about the second distal self-expanding member 411 and the second distal self-expanding member 411 exerts outward radial force on the second distal primary belt 462. The distal primary release wire 442 is axially moveable within the end loops 472 of the second distal primary belt 462 to allow for release of the radial constraint as discussed above with respect to the proximal primary release wire 443. The distal portion 471 of the distal primary release wire 442 is also disposed within end loops 473 of the first distal primary belt 458 and radially constrains the first distal self-expanding member 422 in a similar fashion.
Although the distal primary release wire 442 and proximal primary release wire 443 are shown as two separate components, the release wires 442 and 443 could be combined into a single release member, such as a branched release wire. A branched release wire is capable of releasing multiple belts in a desired sequence by proper configuration of the lengths of the various branches of the wire. The relative amount of the release wire extending beyond the looped ends of the belt controls the timing of the release of the belts. Alternatively, a single release wire may engage both distal and proximal primary belts 456, 458 and 462. As this single release wire 150 is moved proximally, the first distal primary belt 458 is first released, followed by the release of the second distal primary belt 462 and then release of the proximal primary belt 456.
A distal portion 474 of a secondary release member in the form of a secondary release wire 475 is disposed within end loops 476 of a secondary belt 464 that radially constrains the proximal self-expanding member 408 of the contralateral leg 405. The proximal self-expanding member 408 of the contralateral leg 405 exerts outward radial force on the secondary belt 464 when the self-expanding member 408 is in a constrained configuration. The secondary release wire 475 is axially moveable within the end loops 476 of the secondary belt 464.
A proximal end 477 of the secondary release wire 475 passes into an inner lumen 484 of a release strand tube 438, as seen in FIG. 3. The release strand tube 438 will be described in more detail hereinafter. The release wires 442, 443 and 475 are generally made from a biocompatible high strength alloy such as stainless steel, but can also be made from any other suitable materials. Examples include other metallic alloys such as nickel titanium, non-metallic fibers such as carbon, polymeric materials, composites thereof, and the like. The diameter and stiffness of the release wires 442, 443 and 475 can be selected in accordance with the diameter and stiffness of the belts 456, 458, 462 and 464. The configuration of the end loops 468, 472, 473 and 476 of the belts 456, 458, 462 and 464 may vary to suit the particular embodiment of the delivery system 400 and device to be delivered, as illustrated in FIGS. 7C-7H of U.S. Patent Application Publication No. US 2004/0138734, which is incorporated herein in its entirety by reference.
Referring to FIGS. 3 and 3A-3C, the release strand tube 438 of the present embodiment generally comprises a tubular body 435 extending between a distal end 438A and a proximal end 438B. The tubular body 435 is preferably manufactured from a thermoplastic material, for example, PebaxTM or nylon, with or without a radiopaque material, for example, tungsten, bismuth or barium sulfate, mixed therewith. The tubular body 435 defines a lumen 484 extending substantially the length thereof. In the present embodiment, the body 435 includes a single lumen 484, but as described in other embodiments, the tubular body 435 may define more than one lumen 484.
The lumen 484 of the present embodiment is configured to receive the secondary release wire 475 such that the proximal end 477 thereof is adjacent to the proximal end 438B of the release strand tube 438. The release strand tube 438 may configured with sufficient column strength to facilitate pulling of the release wire 475 relative thereto. Alternatively, a separate instrument or the like may be utilized. The present embodiment includes a through passage 440 extending from the outer surface of the tubular body 435 to the lumen 484. The secondary release wire 475 extends through the passage 440 and through the lumen 484. An access opening 439 is provided in the proximal end 438B of the release strand tube 438 to facilitate access to the proximal end 477 of the secondary release wire 475. During delivery of the device 400, while the proximal end 438B of the release strand tube 438 is being passed through the patient, a cover 437 is positioned over the access opening 439. The cover 437 may be retained by an adhesive or the like. When access to the secondary release wire 475 is desired, the cover 437 is peeled away to reveal the access opening 439 which is in communication with the lumen 484. Alternatively, the cover 437 may be an integral part of the tubular body 435 which is cut away when access to the secondary release wire 475 is desired. To prevent accidental deployment of the proximal self-expanding member 408, the cover 437 is preferably removed just prior to deployment, although such is not required.
Again referring to FIG. 3, the distal end 438A of the release strand tube 438 is connected directly to the proximal end 483 of the secondary belt support member 454. The release strand tube 438 may interconnected in various manners, including, but not limited to, adhesives, bonding, ultrasonic welding, metallic welding, hot melt bonding, compression fitting, barbs, or any other suitable means. Alternatively, the release strand tube 438 and the secondary belt support member 454 may be formed integral with one another, either from similar material or different materials, for example, using a multi-step molding process.
Referring to FIGS. 4-15, various configurations for the distal and proximal ends 438A and 438B of the release strand tube 438 will be described. In each of these embodiments, the tubular body 435′ includes a first lumen 484 configured to receive the secondary release wire 475 and a second lumen 481 configured to receive a secondary support strand 481. The secondary support strand 481 is connected to the proximal end 483 of the secondary belt support member 454. As will be described hereinafter, in each embodiment, the secondary support strand 481 is in turn connected to the release strand tube 438. Movement of the release strand tube 438 will be translated through the secondary support strand 481 and result in a corresponding force on the secondary belt support member 454.
In the embodiment illustrated in FIG. 4, both of the lumens 482 and 484 extend to the distal face of the distal end 438A′ of the release strand tube 438 and the corresponding strand/wire enters straight in to the respective lumen 482, 484. The embodiment of FIG. 6 is similar and again both of the lumens 482 and 484 extend to the distal face of the distal end 438A′′ of the release strand tube 438 and the corresponding strand/wire enters straight in to the respective lumen 482, 484. The distal portion 438A′′ further includes a tube 478 manufactured from tetrafluoroethylene or the like which surrounds the secondary support strand 481 and secondary release wire 475 to provide greater protection therefore. The tube 478 may be bonded, welded, heat shrunk or otherwise attached to the distal end 438A′′. Turning to FIG. 7, the lumen 482 extends to the front face of distal end 438′′′ and the secondary support strand 481 is received therein. To further facilitate entry of the secondary release wire 475 in to lumen 484, a portion of the upper surface of distal end 438A′′′ is removed at 477 to enlarge the opening into the lumen 484. The distal end 438A′′′ of FIG. 8 is similar to that of FIG. 7 and additionally includes the tube 478 as described with respect to FIG. 6.
Referring to FIGS. 9-14, various embodiments of the proximal end 438B of the release strand tube 438 will be described. The proximal end 438B′ illustrated in FIG. 9 is similar to the embodiment of FIG. 3 and includes an access opening 439 to access the secondary release wire 475. In the present embodiment, the secondary release wire 475 is glued, bonded or otherwise adhered at 429 within the lumen 484 adjacent to the proximal end 438B′. As such, the secondary release wire 475 can be pulled up from the access opening 439 as indicated by arrow A, but will not come free from the lumen 484. Similarly, the secondary support strand 481 is glued, bonded or otherwise adhered at 429 within the lumen 482 adjacent to the proximal end 438B′. While secondary support strand 481 is illustrated as being bonded adjacent proximal end 438B′, such is not required, and secondary support strand 481 may be bonded further distal along the lumen 482. Additionally, the secondary support strand 481 may be bonded at more than one location. As explained above, bonding of the secondary support strand 481 to the release strand tube 438 causes the secondary support strand 481, and thereby the secondary belt support member 454, to move with the release strand tube 438.
The proximal end 438B′′ of FIG. 10 is similar to the embodiment of FIG. 9, except that the secondary release wire 475 is not bonded, but instead is free to be pulled free through the access opening 439. In both embodiments of FIGS. 9 and 10, instead of a complete opening 439, such may be formed as a closed skive cut which is bent or the like to cause opening thereof as desired.
With respect to the proximal end 438B′′′ of the release strand tube 438 illustrated in FIG. 11, the secondary release wire 475 does not extend to the end of the tube, but instead terminates a distance L from the end. The secondary release wire 475 will still be accessible through the access opening 439 and may either be bonded, as illustrated, or free. The additional length L of the release strand tube 438 will be less rigid without the secondary release wire 475, which increases the ability to snag the release strand tube 438 during the initial passage thereof through the patient. Alternatively, the secondary support strand 481 may terminate a distance from the end, for example, prior to the access opening 439, while the secondary release wire 475 extends substantially to the end. In yet another embodiment, both the secondary release wire 475 and the secondary support strand 481 may terminate at least a distance L from the end of the release strand tube 438, thereby providing a substantially flexible proximal end 438B′′′.
Referring to FIG. 12, the access opening 439 extends to the end of proximal end 438B′′′′, making the secondary release wire 475 easily accessible. To prevent entanglement or the like of the release wire 475 during passage of the release strand tube 438 through the patient, a heat shrink wrap 447 or the like may be provided over the proximal end 438B′′′′. The heat shrink wrap 447 may be made from tetrafluoroethylene, polyolefin or other suitable materials. The heat shrink wrap 447 may be configured to be removed prior to actuation of the secondary release wire 475 or the release wire 475 may be accessible through the access opening 439 with the heat shrink wrap 447 still on the proximal end 438B′′′′.
Referring to FIGS. 13 and 14, a release strand tube 438 with a separable proximal end 438B′′′′′ is illustrated. The proximal end 438B′′′′′ abuts an intermediate portion 438C of the release strand tube 438 and is maintained thereto via a heat shrink tube 478. Other connecting means, for example, adhesives, welding, bonding, clips, straps or any other suitable means, may be used to interconnect the proximal end 438B′′′′′ to the intermediate portion 438C. The intermediate portion 438C may be integral with or a separate component from the distal end 438A. The secondary release wire 475 extends into the proximal end 438B′′′′′ and is bonded thereto as indicated at 429. The secondary support strand 481 may extend into the proximal end 438B′′′′′, but is not bonded thereto. The secondary support strand 481 is bonded in the intermediate portion 438C or the distal end 438A. To actuate the secondary release wire 475, the proximal end 438B′′′′′ is disconnected from the intermediate portion 438C, as illustrated in FIG. 14, by bending, twisting or the like to break the tube 478 in the illustrated embodiment. Other detachment mechanisms may be used if different connecting means are utilized. The proximal end 438B′′′′′ can then be moved proximally relative to the intermediate portion 438C, thereby pulling the secondary release wire 475.
While FIGS. 3-14 illustrate various configurations of the release strand tube 438, other configurations may also be utilized without departing from the invention.
Referring again to FIG. 2, inflation port 421 extends proximally from the proximal end 416 of the ipsilateral leg 404 of the graft 401. The inflation port 421 is coupled to a distal end 487 of the inflation tube 444 by a retention mechanism, such as a retention wire 488. Typically, the retention wire 488 extends from the inflation port 421 proximally to the proximal adapter 427 of delivery system 400. The distal end 487 of the inflation tube 444 can be disengaged from the inflation port 421 by pulling on a proximal end 491 of retention wire 488. The retention wire 488 may be a small diameter wire made from a material such as a polymer, stainless steel, nickel titanium, other alloy or metal, or composite; in a particular embodiment of the invention, retention wire 488 may be a spring formed of a variety of suitable spring materials. Alternatively, the retention wire 488 may have a braided or stranded configuration.
FIG. 2 illustrates proximal adapter 427 which is suitable for use with embodiments of the present invention. The proximal adapter 427 houses the proximal termination of the primary release wires 442 and 443, guidewire tube 436, retention wire 488 and release wire tube 441. The proximal adapter 427 has a first side arm 492 with an inner lumen 493 that secures the proximal end of the release wire tube 441 and second side arm 499 having an inner lumen in fluid communication with inflation material lumen that houses proximal end 491 of retention wire 488. The proximal adapter 427 has a distal primary release wire handle 495 and a proximal s primary release wire handle 496 that are disposed in a nested configuration on the first side arm 492. A proximal end of the proximal primary release wire 443 is secured to the proximal primary release-wire handle 496. A proximal end of the distal primary release wire 442 is secured to the distal primary release wire handle 495. This configuration prevents the operator from inadvertently deploying or activating the proximal primary release wire 443 prior to deployment or activation of the distal primary release wire 442 which could result in an undesirable graft 401 deployment sequence. Various proximal adapters 427 are illustrated in U.S. Patent Application Publication No. US 2004/0138734, which is incorporated herein in its entirety by reference.
FIG. 3 illustrates a belt support member assembly 507 of the delivery system 400. The distal end 508 of the secondary belt support member 454 is slidingly disposed within the secondary belt support member housing 453 that is secured to the primary belt support member 452. The second distal primary belt 462 is secured to the primary belt support member 452 (which in this embodiment is the guidewire tube 436) and extends radially therefrom through an optional second distal primary standoff tube 511. Similar optional first distal primary standoff tube 512, proximal primary standoff tube 513 and optional secondary standoff tube 514 are disposed on the first distal primary belt 458, proximal primary belt 456 and secondary belt 464, respectively.
Having described the components of the various embodiments of the delivery system 400, operation of an illustrative embodiment will be described with reference to FIGS. 15-32. FIG. 15 illustrates generally the anatomy of a patient's heart 515, aorta 516 and iliac arteries 517. The aorta 516 extends from the heart 515 and descends into the abdomen of the patient's body. An aneurysm 518 is disposed in the aorta 516 just below the renal arteries 519. The aorta 516 branches into the right and left iliac arteries 517 below the aneurysm, which then become the femoral arteries 520.
One delivery procedure of the present invention begins with delivery of a first guidewire 530 into an access hole 531 in a femoral artery, the right femoral artery 532 for the procedure depicted in FIG. 16, and advanced distally through the iliac artery 517 and into the patient's aorta 516. Access into the femoral artery 532 is generally accomplished with a standard sheath and trocar kit, although sheathless access may also be employed. It should be noted that although the procedure described herein and illustrated in FIGS. 15-32 is initiated in the right femoral artery 532, the same procedure could be carried out beginning in the left femoral artery 533 with the orientation reversed.
Referring to FIG. 17, with the first guidewire 530 positioned across the aneurysm 518, a second guidewire 534 is then introduced into the ipsilateral or right femoral artery 532 and guided into the iliacs 517 and then back down into the contralateral or left femoral artery 533. A distal end 535 of the second guidewire 534 may then be captured with a snare 536 or similar device inserted through an access hole 537 in the left femoral artery 533. The distal end 535 of the second guidewire 534 may then be pulled out of the left femoral artery 533 through the same left femoral artery access hole 537, providing a continuous length of wire passing through each iliac artery 517 via the left and right femoral artery access holes 537 and 531, as shown in FIG. 17.
Once the second guidewire 534 exits the access hole 537 in the left femoral artery 533, a tubular catheter 538 may be advanced over the second guidewire 534 through the left femoral artery access hole 537 so as to extend out of the body from the access hole 531 in the right femoral artery 532 as shown in FIG. 18. This provides a continuous conduit between the right and left iliac arteries 517. With a distal end 541 of the tubular catheter 538 extending from the access hole 531 in the right femoral artery 532, a distal end 542 of the release strand tube 438 may then be affixed to a proximal end 543 of the second guidewire 534 as shown in FIG. 19. Each of the various embodiments of the release strand tube 438 described above may be utilized herein. Other variations of this tube are also within the scope of the present invention.
The second guidewire 534 is then pulled out of the tubular catheter 538 from the left femoral artery access hole 537, in the direction indicated by the arrow 544 in FIG. 19, so that the release strand tube 438 then extends through the tubular catheter 538 from the right iliac artery to the left iliac artery. The tubular catheter 538 may then be withdrawn, leaving the release strand tube 438 extending through the left and right iliac arteries 517 from the access hole 531 in the right femoral artery 532 to the access hole 537 in the left femoral artery 533, as shown in FIG. 20. The first guidewire 530 remains in position across the aneurysm 518.
Referring to FIG. 21, the delivery system 400 is then advanced into the patient's right femoral artery 532 through the access hole 531 over the first guidewire 530. It may be desirable to apply tension to the release strand tube 438 as the delivery system 400 is advanced to the vicinity of the aneurysm 518 so as to remove slack in the tube 438 and prevent tangling thereof or the like. Tension on the release strand tube 438 may also help to prevent twisting of the delivery system 400 during insertion.
An optional marker band 551 may disposed adjacent nosepiece 434 or generally in the vicinity of the distal end of the delivery system 400. Such a marker band 551 may also be integral with the delivery system 400; for example, it may be incorporated as part of the distal nosepiece 434. A useful marker 551 can be one that does not add to the profile of the delivery system 400. Such a marker may be used to aid the operator in introducing the delivery system 400 without twisting. Various types of marker bands are described in U.S. Patent Application Publication No. US 2004/0138734, which is incorporated herein in its entirety by reference.
The delivery system 400 is positioned in a location suitable for initiating the deployment process, such as one in which the distal end 425 of the delivery system 400 is disposed beyond, or distal to the position in which the graft 401 will be placed, as shown in FIG. 22. This position allows the proximal end 483 of the secondary belt support member 454 to be laterally displaced without mechanical interference from the patient's vasculature.
Once the distal section 426 of the elongate shaft 423 and the endovascular graft 401 are positioned, the deployment process is initiated. First, the outer tubular member 431 is proximally retracted by pulling on the proximal end 433 of the outer tubular member 431 relative to the inner tubular member 430. The inner tubular member 430 should be maintained in a stable axial position, as the position of the inner tubular member 430 determines the position of the constrained bifurcated graft 401 prior to deployment. Upon retraction of the outer tubular member 431, the constrained bifurcated graft 401 is exposed and additional slack is created in the release strand tube 438 as shown in more detail in FIG. 23.
Alternatively, a variety of different components may be substituted for the outer tubular member 431 in some of the embodiments of the invention. For instance, a shroud, corset, mummy-wrap, or other cover may be released or actuated to expose the constrained graft 401 after the delivering system 400 is introduced into the vasculature.
The slack in the release strand tube 438 is taken up by applying tension to the release strand tube 438 as shown by the arrow 563 in FIG. 23. Since, in the present embodiment, the release strand tube 438 is connected directly to the secondary belt support member 454, tension on the release strand tube 438 is applied directly to the secondary belt support member 454. As such, the secondary belt support member 454 begins to slide within the secondary belt support member housing 453 in a proximal direction as shown by the arrow 564 in FIG. 25. The secondary belt support member 454 continues to slide proximally until all the slack is removed from an axially compressed or folded portion 565 of the contralateral leg 405 of the graft 401 shown in FIG. 24 and the primary and secondary belt support members 452 and 454 are oriented relative to the secondary belt support member housing 453 as generally shown in FIG. 26. Rotational movement of the secondary belt support member 454 relative to the secondary belt support member housing 453 is prevented by the non-circular or asymmetric cross section of the member 454 as shown in FIG. 3. This prevents the contralateral leg 405 from twisting or becoming entangled with other components of the graft 401 or delivery system 400 during deployment.
Axial compression of all or a portion of the contralateral leg 405 while the graft 401 is in a constrained state within the delivery system 400 prior to deployment allows the axial position of the two proximal self-expanding members 407 and 408 to be axially offset from each other. Alternatively, graft legs 404 and 405 having different lengths may be used to prevent overlap of the self-expanding members 407 and 408 within the delivery system 400. The cross sectional profile or area of the overlap self-expanding members 407 and 408 is generally greater than that of the adjacent polymer material portion of the legs 404 and 405 of the graft 401, so eliminating the overlap can be desirable. The self-expanding members 407 and 408 are typically made of a metal or metallic alloy and maintain a cylindrical configuration, even when in a constrained state. The polymer material of the legs 404 and 405 or main body portion 402 of the graft 401, by contrast, is relatively soft and malleable and can conform to the shape of whatever lumen in which it may be constrained. Placing both proximal self-expanding members 407 and 408 adjacent each other in a compressed state at a single axial position within the delivery system 400 would require a configuration in which two objects having an approximately circular cross section are being placed within another circular lumen. Such a configuration generates a significant amount of wasted or unused cross sectional area within that axial position of the delivery system 400 and would likely result in less flexibility and greater cross section than a delivery system 400 in which the proximal self-expanding members 407 and 408 are axially offset.
A gap 566 indicated by the arrows 567 in FIG. 27 allows the proximal end 483 of the secondary belt support member 454 to move in a lateral direction without mechanical interference from the carina 568 of the iliac artery bifurcation 569.
Gap 566 may vary depending on the patient's particular anatomy and the specific circumstances of the procedure.
The lateral movement of the contralateral leg 405 and secondary belt support member 454 is accomplished by application of tension on the release strand tube 438. This movement away from the primary belt support member 452 allows the secondary belt support member 454 to transition from alignment with the right iliac artery 572 to alignment with the left iliac artery 573 as shown in FIG. 27. As illustrated in FIGS. 27-31, an obturator 598 may be utilized to assist in moving and positioning the secondary belt support member 454 and the contralateral leg 405. The obturator 598 is slid over the release strand tube 438 and can be connected thereto with a hemostatic valve 599 or the like. The size of the release strand tube 438, relative to the small diameter strands, is large enough such that the hemostatic valve 599 provides a secure connection between the obturator 598 and the release strand tube 438. As such, movement of the obturator 598 will directly control movement of the release strand tube 438, and thereby the secondary belt support member 454 which is attached thereto. Even in the multi-lumen embodiments of the release strand tube 438 illustrated in FIGS. 4-14, the secondary support strand 481 is connected to the release strand tube 438 at one or more points, such that operation of the obturator 598 will allow for easy control of the secondary belt support member 454.
Once the ipsilateral leg 404 of the graft 401 and contralateral leg 405 of the graft 401 are aligned with the right and left iliac arteries 572 and 573, respectively, the delivery system 400 may then be retracted proximally, as shown by the arrow 574 in FIG. 28, so as to reposition the distal section 426 of the elongate shaft 423 and the bifurcated graft 401 into the desired position for deployment as shown in FIG. 29.
When deploying the graft 401 in the abdominal aorta 516 it is generally desirable to ensure that the distal end 403 of the graft main body portion 402 is installed proximal to, or below, the renal arteries 519 in order to prevent their significant occlusion. However, the distal self-expanding members 411 and 422 of the graft 401 may, depending upon the anatomy of the patient and the location of the aneurysm 518, partially or completely span the ostia 575 of one or both renal arteries 519. It can be desirable, however, to ensure that ostia 575 of the renal arteries 519 are not blocked by the distal end 403 of the graft main body portion 402. As discussed previously, a variety of imaging markers may be used on either or both the delivery system 400 and the graft 401 itself to help guide the operator during the graft positioning process.
After proper positioning, the first and second distal self-expanding members 411 and 422 may then be deployed. The operator first unscrews or otherwise detaches a threaded portion of the distal primary release wire handle 495 and the distal primary release wire handle 495 is proximally retracted, which in turn retracts the distal primary release wire 442 in a proximal direction. As the distal end 582 of the distal primary release wire 442 passes through the end loops 472 and 473 of the first distal primary belt 458 and second distal primary belt 462, the end loops 472 and 473 are released, freeing the first distal self-expanding member 422 and second distal self-expanding member 411 to self-expand in an outward radial direction so to contact an inner surface 583 of the patient's aorta 516. The first and second distal primary belts 458 and 462 remain secured to the primary belt support member 452 and will eventually be retracted from the patient with the delivery system 400 after deployment is complete.
As the first and second distal self-expanding members 411 and 422 expand and contact the aorta 516, a distal end 403 of the graft main body portion 402 opens with the self-expanding members 411 and 422 and promotes opening of the graft polymer material portion from the flow of blood into the distal end 403 of the graft main body portion 402 with a “windsock” effect. As a result, once the first and second distal self-expanding members 411 and 422 are expanded to contact the aorta inner surface, the graft main body portion 402 and legs 404 and 405 balloon out or expand while the proximal ends 416 and 417 of the legs 404 and 405 of the graft 401 remain constricted due to the constrained configuration of the proximal self-expanding members 407 and 408 of the ipsilateral and contralateral legs 404 and 405. At this point, there typically will be partial or restricted blood flow through and around the graft 401.
Bifurcated graft 401 may then be optionally be inflated with an inflation material via inflation tube 444 and inflation port 421 until the inflatable channels 418 and inflatable cuffs 413, 414 and 415 have been filled to a sufficient level to meet sealing and other structural requirements necessary for the bifurcated graft main body portion 402 and the ipsilateral and contralateral legs 404 and 405 to meet clinical performance criteria. Inflating the graft 401 prior to deploying the proximal and distal self-expanding members 407 and 408, respectively, may be useful in anatomies where the vasculature is tortuous or angled.
Next, the proximal self-expanding member 407 of the ipsilateral leg 404 is deployed. Deployment of the first and second distal self-expanding member 411 and 422 has exposed the proximal primary release wire handle 496, making it accessible to the operator. The proximal primary release wire handle 496 is retracted proximally so as to deploy the proximal primary belt 456 and proximal self-expanding member 407 of the ipsilateral leg 404.
FIGS. 29 and 30 depict an enlarged view of the proximal end 483 of the secondary belt support member 454. The proximal self-expanding member 408 of the contralateral leg 405 is secured to the proximal end 417 of the contralateral leg 405. The proximal self-expanding member 408 is constrained in a radial direction by the secondary belt 464, which has end loops 476 releasably constrained by the distal end 587 of the secondary release wire 475. To access the proximal end 477 of the secondary release wire 475, the covering 437 over access opening 439 is peeled away. The proximal end of the secondary release wire 475 is accessed through the access opening 439 and the secondary release wire is pulled in the proximal direction to release the distal end 587 of the secondary release wire 475 from the end loops 468 of the secondary belt 464 so as to release the radial constraint on the proximal self-expanding member 408 imposed by the secondary belt 464. Upon release of the radial constraint, the proximal self-expanding member 408 expands so as to contact an inside surface 592 of the left iliac artery 573 as shown in FIG. 31. Once the proximal self-expanding member 408 of the contralateral leg 405 is expanded, the operator may then apply tension to the obturator 598 in the proximal direction to withdraw the obturator 598 which, through its connection, withdraws the release strand tube 438, which in turn, withdraws the secondary belt support member 454. As shown in FIG. 32, the secondary belt support member 454 slides from the housing 453 and is easily removed from the patient's vasculature through the left femoral artery access hole 537.

## Claims

1. A delivery system for a bifurcated intracorporeal device comprising:
a shaft having a distal section supporting:
a primary support member positioned to be disposed within at least a primary portion of the bifurcated intracorporeal device; and
a secondary support member adjacent the primary support member and positioned to be disposed within a secondary portion of the bifurcated intracorporeal device;
at least one belt configured to be circumferentially disposed about a portion of the secondary support member so to at least partially constrain the secondary portion of the bifurcated intracorporeal device;
a tube including a distal end which is directly connected to the secondary support member such that movement of the tube is translated to a corresponding force on the secondary support member; and
a release member configured to engage and releasably secure the belt in a constraining configuration, the release member extending through at least a portion of the tube such that the release member is accessible adjacent a proximal end of the tube.

2. The delivery system of claim 1 wherein the bifurcated intracorporeal device is a bifurcated endovascular graft.

3. The delivery system of claim 1 wherein the release member comprises a release wire moveably disposed within opposed looped ends of the belt.

4. The delivery system of claim 1 further comprising a secondary support member housing secured to the primary support member wherein the secondary support member is configured to move axially within the housing and the housing and secondary support member are configured to prevent relative rotational movement therebetween.

5. The delivery system of claim 1 wherein the distal end of the tube is adhesively bonded to the secondary support member.

6. The delivery system of claim 1 wherein the distal end of the tube is welded to the secondary support member.

7. The delivery system of claim 1 wherein the distal end of the tube is formed integrally with the secondary support member.

8. The delivery system of claim 1 wherein a portion of the distal end of the tube is removed to define an enlarged opening into a tube lumen.

9. The delivery system of claim 1 wherein an access opening in communication with a tube lumen is formed adjacent the proximal end of the tube to facilitate access to the release wire.

10. The delivery system of claim 9 wherein the access opening is formed by cutting away a portion of the proximal end of the tube.

11. The delivery system of claim 9 wherein the access opening is formed by providing a skive portion of the proximal end of the tube which is broken open to provide access.

12. The delivery system of claim 9 further comprising a removable cover positioned over the access opening.

13. The delivery system of claim 9 further comprising a heat shrink wrap over at least a portion of the access opening.

14. The delivery system of claim 9 wherein the release member is bonded within the tube lumen proximal from the access opening.

15. The delivery system of claim 1 wherein the release member is bonded within a tube lumen adjacent the proximal end and the proximal end of the tube is releasably connected to an intermediate portion of the tube such that the release member is actuated by disconnecting the proximal end of the tube from the intermediate portion and moving the proximal end of the tube proximally relative to the intermediate portion.

16. The delivery system of claim 15 wherein the intermediate portion is formed integrally with the distal end of the tube.