Patent ID: 12186215

DETAILED DESCRIPTION

The following detailed description is now directed to certain specific embodiments of the disclosure. In this description, reference is made to the figures wherein like parts are designated with like numerals throughout the description and the drawings. Described below are various embodiments of a delivery system for establishing a surgical platform having multiple guidewires. In some aspects, the present disclosure is directed to devices and methods for deploying a vascular graft for treatment of an abdominal aortic aneurysm, including a deployment catheter and a guidewire assembly which may be used to maintain access through an implanted vascular graft for subsequent catheterizations.

An abdominal aortic aneurysm usually arises in the infrarenal portion of the diseased aorta, for example, below the kidneys. The aneurysm often occurs near a site of vessel branching, making a bifurcated stent a well-suited device for treating the abdominal aortic aneurysm. Endoluminal implantation is an increasingly accepted technique for implanting vascular grafts. This procedure may involve femoral cut down access or percutaneously inserting a vascular graft or prosthesis by using a delivery catheter. This process eliminates the need for major surgical intervention, thereby decreasing the risks associated with vascular and arterial surgery. Various embodiments of catheter delivery systems for prosthetic devices are described herein.

Endovascular surgical procedures can use a guidewire to help position a catheter or place prosthesis. Guidewires can provide a surgical platform from which a physician can conduct a minimally-invasive medical procedure. In some instances, a physician may use multiple guidewires in a medical procedure. When multiple guidewires are used, a first guidewire may have at least one of its ends in a location that is different from at least one of the ends of a second guidewire. When multiple guidewires are used, at least a portion of a first guidewire may be located in proximity to at least a portion of a second guidewire. In some instances, one end of a first guidewire may be located next to a portion of a second guidewire while the other end of the first guidewire is at a location different from the location of the end of the second guidewire. A first guidewire may access the patient at one location and be joined within the patient to a second guidewire that accesses the patient from a different location. Guidewires that access the patient's body from different locations can be used to deploy a bifurcated stent, to seat a heart valve, or to perform an endovascular surgical procedure.

Certain current delivery systems for a bifurcated stent graft system or a graft having at least one branch portion may use two separate sheaths to deploy the distal segment of the graft before the proximal segment. The outer sheath is first retracted to deploy a portion of the mid-body and the contralateral limb. Then, the front sheath is advanced distally to deploy the distal end of the graft, See e.g., U.S. Pat. No. 6,660,030. Other delivery systems, for example as disclosed in U.S. patent application Ser. No. 11/522,292, titled “A MULTI-SEGMENTED GRAFT DEPLOYMENT SYSTEM” and filed on Sep. 15, 2006 (the entirety of which is hereby incorporated by reference as if fully set forth herein) may use a plurality of axially spaced releasable restraint members temporarily connected by a pull wire to allow the distal main branch portion to be deployed before a proximal graft portion. Typically, these delivery systems are delivered to the aneurysm location over a guidewire. The guidewire may be further used to release a branch graft portion of the prosthesis, for example, by operably connecting a branch graft restraint mechanism to the guidewire and proximally withdrawing the guidewire from the vasculature.

Once the bifurcation graft has been deployed and implanted, a variety of procedures may desirably be accomplished. For example, it may be advantageous to implant a cuff (e.g., on the proximal end of the main branch portion) to secure the graft and thereby prevent movement or slippage of the main branch portion. Alternatively, it may be necessary to dilate the stenosis or touch up or re-establish the expansion of the graft. These procedures require advancing another catheter to the graft location along a guidewire. However, the positioning of a guidewire through the graft after the graft has been deployed is difficult since the tip of the guidewire may snag on the wire support cage of the graft. Thus, it may be advantageous to provide a guidewire assembly configured to remain placed through a graft once the graft has been deployed and to allow access through the expanded graft for subsequent catheterizations. Additionally, it may be advantageous to improve the configuration of the deployment catheter and/or the graft restraining members so as to improve the methods of deploying and positioning bifurcated and non-bifurcated grafts, as will be described herein.

In certain embodiments, the deployment catheter may be configured to deliver a graft that includes a main or distal graft portion and at least one branch or proximal graft portion. In certain embodiments, the hollow guidewire assembly may be associated with a restraint member for the branch segment, such that the branch segment may be deployed by the guidewire assembly. The guidewire assembly may be further configured such that it may be used to remove the restraint member from the branch segment while permitting placement and maintenance of a guidewire through the expanded branch segment and main body graft for subsequent catheterizations. Other embodiments of a graft deployment system and guidewire assembly will also be described below.

Prosthesis

FIG.1Ais a schematic representation of an example of a bifurcated vascular graft50that can be used with any embodiment of the deployment catheter disclosed herein, positioned at the bifurcation between the abdominal aorta30and the right and left common iliac arteries37and38. With reference toFIG.1A, there is illustrated a schematic representation of the abdominal part of the aorta and its principal branches. In particular, the abdominal aorta30is characterized by a right renal artery2and left renal artery4. The large terminal branches of the aorta30are the right and left common iliac arteries37and38. Additional vessels (e.g., second lumbar, testicular, inferior mesenteric, middle sacral) have been omitted fromFIG.1Afor simplification. One embodiment of an expanded bifurcated endoluminal vascular prosthesis is shown spanning aneurysms103,104and105. The expanded bifurcated endoluminal vascular graft50can comprise a main branch portion52(also referred to herein as a main branch segment) for traversing the aorta, a first branch portion54(also referred to herein as a first branch segment or an ipsilateral branch portion) for spanning an ipsilateral iliac artery37, and a second branch portion56(also referred to herein as a second branch segment or a contralateral branch portion) for spanning a contralateral iliac artery38.

The terms “first” and “second” may be used interchangeably. In one embodiment, the first branch portion can refer to a downstream or upstream portion of a main branch vessel. For example, in one embodiment, the main branch portion and the first branch portion are configured to lie within at least a portion aortic arch (including, for example, the ascending and/or descending aorta) with main branch portion positioned closer to the heart while the second branch portion can be configured to extend into one of the branch vessels (left subclavian, right subclavian or carotid) that extend from the aortic arch.

FIG.1Bis an exploded view of the bifurcated graft50ofFIG.1A, which can include a self-expanding wire support cage60and an outer polymeric sleeve68. In FIG.1B, the wire support60is shown separated from an outer polymeric sleeve68. In the illustrated embodiment, the polymeric sleeve68can be situated concentrically outside of the tubular wire support60. However, other embodiments may include a sleeve positioned instead concentrically inside the wire support or positioned on both the inside and the outside of the wire support. Alternatively, the wire support may be embedded within a polymeric matrix or layer which makes up the sleeve. The sleeve68may be attached to the wire support60by any of a variety of suitable manners known to those skilled in the art.

The tubular wire support60can comprise a main branch portion62for traversing the aorta, a first branch portion64(also referred to herein as an ipsilateral branch portion) for spanning an ipsilateral iliac and a second branch portion66(also referred to herein as a contralateral branch portion) for spanning a contralateral iliac. The main branch portion62and first ipsilateral branch portion64can be formed from a continuous single length of wire having a proximal end, a distal end and a central lumen extending therebetween. Alternatively, the first ipsilateral branch portion64may be formed of one or more lengths of wire pivotably connected to the proximal end of the main branch portion62. A second, contralateral branch component66may be formed of one or more lengths of wire pivotably connected to the proximal end of the main branch portion62. Each of the iliac branch components has a proximal end, a distal end and a central lumen extending therethrough. Construction of the graft from a three part cage conveniently facilitates the use of different gauge wire in the different components (e.g. 0.014 in. diameter main trunk and 0.012 in. diameter branch components).

In general, each of the components of the bifurcated endoluminal vascular graft50may vary considerably in diameter, length, expansion coefficient, and other parameters or characteristics, depending upon the intended application. For implantation within the aorta of a typical adult, the main branch portion52will have a length within the range of from approximately 2 in. or less to approximately 5 in. or more, and, typically within the range of from approximately 3.5 in. to approximately 4 in. The unconstrained outside expanded diameter of the main branch portion52will typically be within the range of from approximately 0.75 in. to approximately 1.5 in. The unconstrained expanded outside diameter of the main branch portion52can be constant or substantially constant throughout the length, or can be tapered from a relatively larger diameter at the distal end to a relatively smaller diameter at the bifurcation. In general, the diameter of the proximal end of the main branch portion will be on the order of no more than approximately 95% and often no more than approximately 85% of the diameter of the distal end of the main branch portion. The iliac branch portions54and56will typically be bilaterally symmetrical, having a length within the range of from approximately 0.4 in. to approximately 2.6 in., and a diameter within the range of from approximately 0.04 in. to approximately 0.79 in.

The collapsed prosthesis for use in accordance with the present disclosure has a diameter in the range of approximately 0.08 in, to approximately 0.39 in. The maximum diameter of the collapsed prosthesis can be in the range of approximately 0.12 in. to approximately 0.24 in. (12 to 18 French). Some embodiments of the deployment catheter, including the prosthesis, can have a diameter in the range of from approximately 18 to approximately 20 or approximately 21 French. Other embodiments can have a diameter as low as approximately 19 French, approximately 16 French, approximately 14 French, or smaller. After deployment, the expanded endoluminal vascular prosthesis may radially self-expand to a diameter anywhere in the range of approximately 0.8 in. to approximately 1.6 in.

Although certain prosthesis configurations are disclosed herein, these are only examples of prostheses which are deployable using the embodiments of a deployment catheter and guidewire assembly described herein. In other embodiments, the delivery system described below may be used to deliver and deploy other types of self-expandable bifurcated or multi-segmented prosthesis having a main branch portion and at least one branch graft portion, as will be apparent to those of skill in the art in view of the disclosure herein. For example, in other embodiments, certain features and aspects of the deployment catheter and guidewire assembly can be used to deploy a graft without a branch graft portion, a graft with only one branch portion and/or a graft with more than one graft portions. Further details and additional embodiments of the prosthesis described above can be found in U.S. Pat. Nos. 6,007,296, 6,187,036, and 6,197,049, the entirety of each of which is hereby incorporated by reference herein.

It should also be appreciated that, although the illustrated embodiments are described in the context of a bifurcated graft configured for the abdominal aorta, certain features and aspects of the delivery systems and methods described herein can be used in other portions of the vascular system. For example, it is anticipated that certain features and aspects of the systems and methods described herein can be adapted for use in the thoracic aorta. In some embodiments, the deployment catheter120(seeFIG.3) may be configured to treat defects that may include, but are not limited to, abdominal aortic aneurysms, subclavian aneurysms, and thoracic aortic aneurysms, to name a few. It is also anticipated that certain features and aspects of the system described herein may be adapted to deliver a single straight graft segment to the thoracic aorta or other vessels or arteries within the body.

Delivery System

The expandable bifurcation graft50can be deployed at a treatment site with any of a variety of deployment catheters, as will be apparent to those of skill in the art. Any of the embodiments of the deployment catheters disclosed herein may comprise any of the materials, features, or other details of any deployment catheters suitable for deploying an expandable bifurcation graft known in the field. Further details and additional embodiments of the deployment catheter can be found in U.S. Pat. Nos. 8,236,040 and 8,523,931, the entirety of each of which is hereby incorporated by reference herein.

The deployment catheters herein disclosed can be used for deploying a self-expanding bifurcation graft known in the field, or in any of the embodiments disclosed in U.S. Pat. Nos. 6,090,128, 6,500,202, 6,660,030, 8,523,931, and U.S. Pat. Pub. 2008/0071343. The entirety of each of the above-referenced patents and published patent applications is hereby incorporated by reference in their entirety as if fully set forth herein.

With reference toFIG.2, one method for using an embodiment of a deployment catheter120for treating an abdominal aortic aneurysm will be briefly described, without limitation. More detail regarding this deployment method will be described below.FIG.2is a schematic representation of an embodiment of a deployment catheter120for delivering a bifurcated prosthesis or graft50, showing a proximal portion of the main branch portion52of the graft50at least partially deployed within the aorta for illustration purposes. As shown inFIG.2, the deployment catheter120can be introduced into a patient's vasculature through a puncture site in the patient's ipsilateral artery. The deployment catheter120is not limited to treatment of an abdominal aortic aneurysm; it can be configured to treat other aneurysms as discussed more fully herein. Additionally, depending on the clinical requirements, the deployment catheter120can be introduced into the patient's vasculature through puncture sites other than an ipsilateral artery. For example, without limitation, the deployment catheter120can be introduced into the patient's vasculature through a contralateral artery, through a radial artery, or through a subclavian artery.

As illustrated inFIG.2, the deployment catheter120can be advanced over a guidewire226to the desired location within the patient's aorta. The graft50illustrated inFIG.2can include a main branch portion52constrained within a main branch sheath or member186, an ipsilateral branch portion54constrained within and ipsilateral branch sheath or member188, and a contralateral branch portion56constrained within a contralateral branch sheath or member190. Prior to the deployment of the main branch portion52of the graft50as shown inFIG.2, the entire graft can be constrained within an outer sheath128of the deployment catheter120. In brief, the graft50can be exposed by retracting the outer sheath128, and the deployment catheter120can be manipulated so as to position the contralateral branch portion56in the contralateral artery38.

After positioning the graft50in the desired position, illustrated inFIG.2, the main branch portion52of the graft50can be deployed by retracting a sheath release166(e.g., a cord, suture, wire, or likewise), which can cause the perforated main branch sheath186to tear along a side thereof. The remaining portion of the main branch portion52can be deployed by further withdrawing the sheath release166. The main branch sheath186can be attached to the sheath release166, allowing the main branch sheath186to be removed through the ipsilateral access site as the sheath release166is removed through the ipsilateral access site. In other configurations, the main branch sheath186can be separately withdrawn from the contralateral access site or with either the ipsilateral branch sheath188or the contralateral branch sheath190.

In the illustrated embodiment, the contralateral branch portion56of the graft50can be deployed by withdrawing a contralateral guidewire sheath216through a puncture site in the contralateral iliac artery38, causing the contralateral branch sheath190to be withdrawn. Similarly, the ipsilateral branch portion54of the graft50can be deployed by withdrawing the deployment catheter120through a puncture site in the ipsilateral iliac artery37, causing the ipsilateral branch sheath188to be withdrawn either before or after the contralateral branch sheath190is withdrawn.

The deployment method described with reference toFIG.2is not intended to limit the applicability of the deployment catheter120. The deployment catheter120may be configured to deploy a straight, bifurcated, or any other graft configuration into any portion of an artery or other blood vessel in the body. In some embodiments, the deployment catheter120may be used to deploy grafts having anchoring elements that help secure the graft to the vessel wall as well as grafts that do not have anchoring elements. With this brief, non-limiting overview of one method of using the deployment catheter120having been described, additional features and configurations of the deployment catheter120and additional details of this and other deployment methods will now be described.

FIG.3is a cut-away side view of a non-limiting exemplary embodiment of a deployment catheter120. The inner core132of the deployment catheter120can include a guidewire lumen154and a sheath release lumen156extending longitudinally therethrough. The guidewire lumen154can be defined by a central tube170that can be disposed within inner core132. The guidewire lumen154can be defined by a hole bored along a longitudinal axis of the inner core132. In the illustrated embodiment, the guidewire lumen154can extend throughout the entire length of the tubular inner core132, having a distal exit port158and a proximal access port160, as will be understood by those of skill in the art. In use, the deployment catheter120can be advanced into position in the aorta over a guidewire226(shown inFIG.2) extending through the guidewire lumen154, as will be understood by those of skill in the art. A sheath release166(also may be referred to herein as a cord) can be routed through the sheath release lumen156. In the illustrated embodiment, the sheath release lumen156can extend through the entire length of the tubular inner core132, having a distal exit port162and a proximal access port164, as will be understood by those of skill in the art.

In the embodiment of the deployment catheter120, the guidewire lumen154can be co-planar with the centerline axis of the inner core132and the sheath release lumen156. However, this arrangement is not required. In some embodiments, the guidewire lumen154can be not coplanar with the centerline axis of the inner core132and the sheath release lumen156. Therefore, the inner core132may be configured so that the guidewire lumen154and the sheath release lumen156are formed at any desired position in the cross-section of the inner core132.

FIG.4is an enlargement of the portion delineated by the curve4inFIG.3.FIGS.5and6are a cross-sectional view of the embodiment of the deployment catheter120shown inFIG.3taken along line5-5and line6-6, respectively, ofFIG.4. With reference toFIGS.4-6, a bifurcated endoluminal graft50is illustrated in a compressed configuration within the deployment catheter120, prior to the advancement of the inner core132relative to the other sheath128. The graft50can comprise a distal aortic trunk or main branch portion52, a proximal ipsilateral branch portion54, and a proximal contralateral iliac portion56. In the illustrated embodiment, the aortic main branch portion52of the graft50can be constrained within a main branch sheath186. While the embodiment of main branch sheath186is shown with reference to compressing a main branch graft portion52, it is envisioned that the sheath186could alternatively be used to compress and deliver other portions of a multi-segmented vascular graft, such as a branch graft portion, the entire multi-segmented graft, or a single-segment, straight vascular graft. Further, in the illustrated embodiment, the ipsilateral branch portion54can be constrained with a tubular ipsilateral branch sheath188(also referred to herein as the first branch sheath), and the contralateral branch portion56(also referred to herein as the second branch sheath) can be constrained within a generally tubular contralateral branch sheath190. In the illustrated embodiment, the ipsilateral branch sheath188and the contralateral branch sheath190can be open-ended tubular sheaths.

The ipsilateral branch sheath188can constrain substantially the entire length of the ipsilateral branch portion54of the bifurcated graft50. Similarly, in the illustrated embodiment, the contralateral branch sheath190can constrain substantially the entire length of the contralateral branch portion56of the bifurcated graft50. However, in some embodiments, the ipsilateral branch sheath188and/or the contralateral branch sheath190may constrain substantially more or less than the entire length of the ipsilateral branch portion54or the contralateral branch portion56, respectively, of the bifurcated graft50.

With reference toFIG.5, the main branch sheath186can be sized and configured to circumferentially surround the main branch portion52of the bifurcated graft50. However, in some embodiments, the main branch sheath186can be configured to only partially surround the main branch portion52of the bifurcated graft50. The main branch sheath186may extend to the distal end of the contralateral branch portion56of the graft50. In some embodiments, the main branch sheath186can be configured so as to define a notch192along the portion of the length of the main branch sheath186that covers the contralateral branch portion56. In some embodiments, the notch192can be a slit along a portion of the length of the main branch sheath186. In some embodiments, as in the illustrated embodiment, the notch192can remove a portion of the main branch sheath186along a portion of the length of the main branch sheath186that can be less than or equal to approximately half of the perimeter of the main branch sheath186. In some embodiments, the main branch sheath186can be skived to remove a suitable amount of the material comprising the main branch sheath186to allow the ipsilateral or contralateral branch portion54,56of the graft50to deploy upon retraction of the outer sheath128. Thus, in some embodiments, the main branch sheath186may not constrain the ipsilateral or contralateral branch portion54,56of the bifurcated endoluminal graft50.

In some embodiments, as illustrated inFIG.4, a torsion tab196can be integrally formed with the central tube170, or secured thereto such as by thermal bonding, adhesive bonding, and/or any of a variety of other securing techniques known in the art. As is illustrated, the main branch portion52of the bifurcated endoluminal graft50can be constrained by the main branch sheath186around the torsion tab196. In the illustrated embodiment, the torsion tab196can engage with the endoskeleton or, with reference toFIG.1B, the wire support cage60of the bifurcated graft50and ensures that the bifurcated graft50substantially rotates with the inner core132of the deployment catheter120. In other words, the torsion tab196can prevent the central tube170from rotating relative to the bifurcated graft50. This can enhance the ability of the medical practitioner or user to rotate and, hence, maneuver, the graft50and the ipsilateral and/or contralateral branch portions54,56within the patient's aorta by rotating the proximal end of the deployment catheter120, in particular, by rotating the proximal end of the inner core132or the “Y” connector169. As such, the torsion tab196can cause the bifurcated endoluminal graft50to rotate substantially in unison with the central tube170.

As described in greater detail below, a locking assembly300can couple with the central tube170. The locking assembly300may be integrally formed with the central tube170, or secured thereto such as by thermal bonding, adhesive bonding, and/or any of a variety of other securing techniques known in the art. The locking assembly300can engage a locking portion194b(shown inFIG.17A) of a contralateral guidewire194. The locking portion194bis also referred to herein as a distal end194bor as a stiff region. The contralateral guidewire194can extend distally from the locking assembly300and cannulate the guidewire sheath216. The contralateral guidewire194can then bend proximally back and extend through the main branch portion52of the graft50and into the contralateral branch portion56of the graft50. The contralateral guidewire194and the contralateral guidewire sheath216can extend proximally from the contralateral branch portion56of the graft50and bend back distally, running distally along a gap formed between an inner surface of the outer sheath128and an outer surface of the main branch sheath186. The contralateral guidewire194and contralateral guidewire sheath216can then exit the delivery catheter120through a gap formed between a proximal face of the distal tip174and a distal face of the outer sheath128. The distal tip174may include a groove (not shown) that accommodates the contralateral wire194as the contralateral wire194passes through the junction between the distal tip174and the outer sheath128.

The contralateral branch sheath190can be deployed using the contralateral guidewire sheath216. The ipsilateral branch sheath188can be connected to the inner core132or the interface member168and adapted to be axially proximally withdrawn from the ipsilateral branch portion182of the graft178, thereby permitting the ipsilateral branch portion182to expand to its implanted configuration. The main branch sheath186can retracted with the contralateral branch sheath190or with the ipsilateral branch sheath188.

Method of Use

With reference to the embodiments of the deployment catheter120described above, an exemplary procedure or method of using the deployment catheter120to treat a patient's abdominal aortic aneurysm using the embodiments of the bifurcated endoluminal graft50disclosed above will now be described. However, the methods and devices of the present disclosure are not to be taken as limited to this particular illustrative example. The present methods and systems can be used in any medical procedure where one desires to reversibly couple catheters, sheaths, guidewires, or similar devices.

In the illustrated embodiment the main branch sheath186and the ipsilateral branch sheath188are introduced into the patient through the ipsilateral access site and removed from the patient through the ipsilateral access site, while the contralateral branch sheath190is introduced through the ipsilateral access site and removed through the contralateral access site.

FIG.7is a schematic representation of an embodiment of the deployment catheter120with the contralateral guidewire sheath216positioned across the bifurcation and within the contralateral iliac artery38. The hollow contralateral guidewire sheath216can be introduced into the ipsilateral iliac artery37through an ipsilateral access site in the femoral artery, advanced superiorly towards the aorta30, and using cross-over techniques known to those skilled in the arts, subsequently advanced inferiorly down the contralateral iliac artery38and out a contralateral access site in the contralateral femoral artery. The leading portion216bof the contralateral guidewire sheath216can be externalized by passing the leading portion216bof the contralateral guidewire sheath216through the contralateral access site. As discussed below, the guidewire sheath216can be secured to the contralateral branch sheath190. The contralateral branch portion56of the bifurcated graft50can be deployed by withdrawing the contralateral guidewire sheath216and thereby removing the contralateral branch sheath190from the contralateral branch portion56of the graft50. The contralateral branch sheath190can be removed through the contralateral access site by pulling on the contralateral guidewire sheath216.

FIG.8is a schematic representation, as inFIG.7, with the deployment catheter120positioned in the aorta30. Referring toFIG.8, after the contralateral guidewire sheath216the has been positioned across the bifurcation228in the aorta30, the deployment catheter120can then be advanced over a second guidewire226(also referred to as the main guidewire), such as but not limited to a standard 0.035 in. guidewire, from the ipsilateral access site into the aorta30using techniques known to those skilled in the arts. Traction can be applied to the hollow contralateral guidewire sheath216from the contralateral access site to take up the slack in the contralateral guidewire sheath216as the deployment catheter120is advanced into the aorta30.

FIG.9is a schematic representation with the ipsilateral and contralateral branch portions54,56of the graft50compressed within the ipsilateral and contralateral branch sheaths188,190(respectively) and positioned substantially fully within the respective ipsilateral and contralateral iliac arteries. As shown inFIG.9, the bifurcated graft50can be configured so as to abut against the bifurcation of the aorta228or be positioned in the vicinity of the bifurcation of the aorta228by retracting the deployment catheter120and, if desired, the contralateral guidewire sheath216until the bifurcated graft50abuts or is in the vicinity of bifurcation of the aorta228. The contralateral guidewire194can be manipulated so as to seat the graft50onto the bifurcation228of the aorta30.

FIG.10is a schematic representation, as inFIG.9, with a proximal portion of the main branch portion52of the graft50or at least partially deployed within the aorta30. The proximal portion of the main branch portion52of the graft50can be partially deployed within the aorta30as illustrated by proximally retracting the sheath release wire166, as described above, while holding the inner core132of the deployment catheter (seeFIG.3) in a fixed position relative to the aorta30so as to prevent exerting undue force on the bifurcation228of the aorta30or other portions of the anatomy. Deploying the graft50in a bottom up sequence, as illustrated herein, may help mitigate the “wind socking” effect that can cause proximal migration of the graft50. Additionally, deploying the graft50and a bottom up sequence may allow for either axially or rotationally repositioning of a partially deployed graft50without causing significant or any damage to the arterial wall. In some embodiments, this may partly be due to the fact that the deployed middle portion of the graft50may move against the arterial wall more easily than a deployed end portion of the graft50. The main branch sheath186can be attached to the sheath release wire166and withdrawn from the patient through the ipsilateral access site.

FIG.11is a schematic representation, as inFIG.10, following the further proximal retraction of the contralateral guidewire sheath216and, consequently, the contralateral branch sheath190, through the contralateral iliac artery38. As illustrated therein, the contralateral branch sheath190has been retracted so as to completely deploy the contralateral branch portion56of the bifurcated graft50. The contralateral guidewire194may remain coupled to the locking assembly300as the contralateral guidewire sheath216is withdrawn through the contralateral access site.

FIG.12Ais a schematic representation, as inFIG.11, following the proximal retraction of the ipsilateral branch sheath188and deployment of the ipsilateral branch portion54of the graft50. The ipsilateral branch portion54of the graft50may be deployed by proximally retracting the inner core132which, as described above, can be directly or indirectly rigidly attached to the ipsilateral branch sheath188(seeFIG.3). Because the ipsilateral branch sheath188can be an open-ended tubular sheath, the ipsilateral branch portion54of the graft50can be deployed in a top down sequence.

However, the ipsilateral branch sheath188(and the contralateral branch sheath190) can be configured to accommodate any other desired or suitable sequence. In some embodiments, the ipsilateral branch portion54of the bifurcated graft50may be deployed before deployment of the contralateral branch portion56of the graft50. Additionally, although the figures illustrate the main branch portion52of the graft50being deployed with the contralateral branch portion56, in other embodiments, the main branch portion52of the graft50may be deployed with the ipsilateral branch portion54. Also, although the figures illustrate the ipsilateral branch portion54being deployed before the contralateral branch portion56, in other methods, the contralateral branch portion56may be deployed before the ipsilateral branch portion54of the graft50.

In the illustrated embodiment depicted inFIG.12A, the contralateral guidewire194remains coupled to the locking assembly300after deployment of the bifurcated graft50. The locking assembly300retains the distal end194b(shown inFIG.17A) of the contralateral guidewire194to prevent unintended movement of the distal end of the contralateral guidewire194. The locking assembly300can be configured to allow the medical technician to actuate the locking assembly300, thereby triggering the locking assembly300to release the distal end of the contralateral guidewire194.

Referring toFIGS.12B-D, release of the contralateral guidewire194from the locking assembly300may be accomplished by advancing a release member311(e.g., pigtail catheter) along the contralateral guidewire194. The release member311can then directly or indirectly apply a vertical force to the contralateral guidewire194, thereby causing the locking assembly300to release the distal end194bof the contralateral guidewire194. The release member311can then be withdrawn through the contralateral access site. The contralateral guidewire194can be withdrawn before, after, or at the same time as the withdrawal of the release member311. Additionally or alternatively, the release member311can be configured to release the contralateral guidewire194upon the activation of a triggering element that is coupled to the locking device300, as described below.

Although the illustrated method shows the ipsilateral branch portion54of the graft50being released before withdrawing the contralateral guidewire194, in some methods, the contralateral guidewire194may be released (e.g., as shown inFIGS.12B-12D) prior to releasing the ipsilateral branch portion54(e.g., as shown inFIG.12A).

Locking Assembly

FIG.13Ais a schematic representation of a locking assembly300. The locking assembly300may be interfaced with (e.g., removably coupled, permanently secured, or integrally formed with) a first elongate member303and a second elongate member305. The locking assembly300may be configured to interface with more than two elongate members. The first elongate member303may pass through the locking assembly300. The locking assembly300can interface with an anchor portion307of the first elongate member303. The locking assembly300may reversibly couple to a locking portion309of the second elongate member305.

FIG.13Bis a non-limiting example of a locking assembly300that can be used with any embodiment of the deployment catheter120disclosed herein. In general, the locking assembly300presently disclosed can be configured to secure two elongate members to the locking assembly300. The locking assembly300can be adapted to release one of the elongate members from the locking assembly300when a user applies a vertical force to the elongate member being released. The locking assembly300presently disclosed can be used in medical procedures that employ a junction of two wires from different locations, such as procedures deploying bifurcated stents or multiple stents in thoracic, renal, or cardiac procedures. By way of a non-limiting example, the locking assembly300can be used to join a contralateral guidewire to an ipsilateral catheter when deploying a bifurcated stent in order to treat an abdominal aortic aneurysm. Certain aspects of the locking assembly300will now be described by presenting a variety of non-limiting exemplary embodiments of the locking assembly300.

Referring toFIG.13B, the locking assembly300can include a housing301having a distal face302and a proximal face304. As shown inFIG.13B, the proximal and distal faces304,302may be substantially perpendicular to the longitudinal axis306. However, in other configurations the proximal and distal faces304,302may not be substantially perpendicular to the longitudinal axis306and/or parallel with each other. The locking assembly300can include an anchoring surface308that defines a first lumen310. The first lumen310may communicate between the distal face302and the proximal face304of the housing301. As shown inFIG.13B, the first lumen310may be concentric to the longitudinal axis306of the locking assembly300. However in other configurations, the first lumen310may be off-center of the longitudinal axis306of the locking assembly300.

The elongate member can pass through the first lumen310of the locking assembly300, e.g., the central tube170of the delivery catheter120can pass through the first lumen310. The locking assembly300can be integral with the central tube170or bonded to the central tube170so that there is no relative movement between the locking assembly300and the central tube170as the central tube170is moved in a distal or proximal direction. The central tube170can be secured to the anchoring surface308such as by thermal bonding, adhesive bonding, crimping, or any of a variety of other securing techniques known in the art.

Additionally or alternatively, the locking assembly300can include a second lumen312. The second lumen312is a passage between the distal face302and the proximal face304of the housing301. However, in other configurations, the second lumen312may communicate only with the distal face302, and not with the proximal face304, of the housing301. The second lumen312can be configured to retain a second elongate member (e.g., the contralateral guidewire194) to the locking assembly300. The contralateral guidewire194can be released from the second lumen312upon activation of the locking assembly300by a user.

The locking assembly300can include a first recess314that extends from a lateral wall316of the housing301toward the longitudinal axis306of the locking assembly300. The second lumen312can communicate with the first recess314. Additionally or alternatively, the first lumen310can communicate with the first recess314. The locking assembly300can include a second recess320that extends from the lateral wall316of the housing301toward the longitudinal axis306of the locking assembly300. The locking assembly300can include a divider322that is interposed between the first recess314and the second recess320. The locking assembly300can include a through-hole324that extends through the divider322and communicates between the first and second recesses314,320to form a recessed portion.

A proximal portion326of the locking assembly300can be tapered. The proximal portion326can be tapered so that the transverse cross-sectional area of the proximal portion326decreases along the proximal direction. The proximal portion326can be tapered to allow the proximal portion326to be withdrawn out of the graft50and back into the outer sheath128without having the locking assembly300getting caught on the graft50or the outer sheath128or any other intervening structure. The locking assembly300can have a taper angle defined as the angle between the longitudinal axis306of the locking assembly300and the lateral wall of the proximal portion of the locking assembly300. The taper angle can be between about 15 and 60 degrees, between about 20 and 45 degrees, and between about 25 and 35 degrees. The taper angle can be 30 degrees with a tolerance of 1 degree.

A distal portion330of the locking assembly300can include a protrusion332, extending radially outward from housing301. The protrusion332may circumferentially surround the entire distal portion330of the locking assembly300, or may surround only a portion of the distal portion330of the locking assembly300. The protrusion332may extend from only a portion of the distal portion330. The second lumen312can be interposed between the protrusion332and the first lumen310. The protrusion332can be configured to provide strain relief to an elongate member that extends distally from the second lumen312and then bends back in the proximal direction. The protrusion332can have a radius of curvature between about 0.005 and 0.1 inches, between about 0.01 and 0.05 inches, and between about 0.015 and 0.025 inches. The protrusion332can have a radius of curvature of 0.02 inches with a tolerance of 0.01 inches.

The locking assembly300can have a length dimension that defines the distance between the proximal and distal faces304,302. The length dimension can be between about 0.1 and 1.0 inches, between about 0.2 and 0.5 inches, and between about 0.3 and 0.4 inches. The length dimension can be 0.375 inches with a tolerance of 0.010 inches. The locking assembly300can have a width dimension perpendicular to the length dimension. The width dimension can be between about 0.05 and 0.5 inches, between about 0.1 and 0.3 inches, and between about 0.15 and 0.2 inches. The width dimension can be 0.187 inches with a tolerance of 0.002 inches. The locking assembly300can have a first aspect ratio defined as the length dimension divided by the width dimension. The first aspect ratio can be between about 0.5 and 5, between about 1 and 3, and between about 1.75 and 2.25. The first aspect ratio can be 2.0.

The first lumen310of the locking assembly300can have a diameter of between about 0.01 and 0.2 inches, between about 0.02 and 0.1 inches, and between about 0.04 and 0.06 inches. The first lumen310can have a diameter of 0.055 inches with a tolerance of 0.002 inches. The second lumen312of the locking assembly300can have a diameter of between about 0.01 and 0.1 inches, between about 0.02 and 0.05 inches, and between about 0.03 and 0.04 inches. The second lumen312can have a diameter of 0.033 inches with a tolerance of 0.002 inches. The locking assembly300can have a second aspect ratio defined as the diameter of the first lumen310divided by the diameter of the second lumen312. The second aspect ratio of the locking assembly300can be between about 1 and 3, between about 1.5 and 2. The second aspect ratio of the locking assembly300can be 1.667. The center points of the first and second lumens can be separated from one another by a spacing dimension. The spacing dimension can be between about 0.04 and 0.07 inches, and between 0.05 and 0.06 inches. The spacing dimension can be 0.053 inches with a tolerance of 0.002 inches.

The locking assembly300can include an elastomeric member334. The elastorneric member334may occupy at least a portion of the first recess314. The elastomeric member334can have an outer surface336that is flush with at least a portion of the lateral wall of the locking assembly300. The first recess314can be configured to retain the elastomeric member334within the locking assembly300. Additionally or alternatively, the elastomeric member334may occupy at least a portion of the second recess320. The second recess320can be configured to retain the elastomeric member334within the locking assembly300. The elastomeric member334can be configured to span the divider322. The elastomeric member334can have a first portion that resides in the first recess314while a second portion of the elastomeric member334resides in the second recess320, the first and second portions of the elastomeric member334being connected by a segment of the elastorneric member334that extends through the through-hole324.

The elastomeric member334can be configured to enhance the ability of the second lumen312to retain the contralateral guidewire194of the delivery catheter120. For example, the elastomeric member334can be configured to intrude into at least a portion of the second lumen312. The locking assembly300can be configured so that at least a portion of the elastomeric member334can interface with an elongate member inserted into the second lumen312. The elastomeric member334may form a friction fit with an elongate member inserted into the second lumen312, helping to retain the elongate member in the second lumen312. Different non-limiting exemplary embodiments of the elastomeric member334are discussed below.

FIG.14shows an isometric view of one exemplary embodiment of the elastomeric member334. The elastomeric member334can include a first portion340that is configured to be retained within the first recess314of the locking assembly300. Additionally or alternatively, the elastomeric member334may include a second portion342that is configured to be retained within the second recess320of the locking assembly300. The first portion340can be connected to the second portion342by at least one segment344. In the non-limiting exemplary example depicted inFIG.14the elastomeric member334can include a first portion340joined to a second portion342by two segments344, the segments344being cylindrical in shape. The elastomeric member344can include a segment344having a shape other than cylindrical. The second portion342and the segment344can be configured to enhance retention of the elastomeric member334within the housing301of the locking assembly300. The second portion342can provide a mechanical lock between the elastomeric member334and the housing301of the locking assembly300, thereby increasing the strength of the attachment between the elastomeric member334and the housing301.

The elastomeric member334can include a retention portion346configured to retain a second elongate member305that is inserted into the second lumen312of the locking assembly300. The retention portion346can define an opening348(e.g., through-hole, lumen, or otherwise) that extends at least partially through the elastomeric member334, e.g., between a distal face350and a proximal face352of the elastomeric member334or only in communication with the distal face350of the elastomeric member334. The opening348can be concentric with the second lumen312of the locking assembly300when the elastomeric member334is seated within the first recess314of the locking assembly300.

An end portion of the opening348has a diameter356that can be larger than an intermediate diameter360of an intermediate portion362of the retention portion346. The end portion354of the retention portion346can be configured to guide an elongate member into the intermediate portion356of the retention portion346. The end portion354of the retention portion346can include a canted wall that funnels an inserted elongate member into the intermediate portion356of the retention portion346.

The elastomeric member334can include a passageway defined by a curved surface364that aligns with the first lumen310of the locking assembly300. The curved surface364of the elastomeric member334can interface with (e.g., by bonding) the housing301of the locking assembly300. The housing301of the locking assembly can interface with (e.g., by welding) to the elongate member that passes through the first lumen of the locking assembly300.

The elastomeric member334can include a curved portion366. The curved portion366can be configured to enhance the bonding between the elastomeric member334and the housing301of the locking assembly300.FIG.14Ais a top view of the elastomeric member334depicted inFIG.14.FIG.14Bis an offset rear view of the elastomeric member334depicted inFIG.14, showing the curved portion366in more detail.FIG.14Cis a front cross-sectional view of the elastomeric member334depicted inFIG.14.FIG.14Dis an offset front view of the elastomeric member334depicted inFIG.14.

FIG.15depicts a cross-sectional view of an exemplary embodiment of the locking assembly300. The elastomeric element334can include a retention portion346that at least partially aligns with the second lumen312. The retention portion346can include an opening348having a width370. The width370of the passageway of the retention portion346can be smaller than the width372of the second lumen312, thereby causing at least a portion of the retention portion346to intrude upon the second lumen312. The retention portion346can define an opening348that partially aligns with the second lumen312. For example, the retention portion346may intrude upon the second lumen312from only one side. In some configurations, the retention portion346can be cup-shaped, with the mouth of the cup-shaped retention portion346facing the distal surface302of the locking assembly300.

As discussed, in some embodiments, the retention portion346can include an opening348formed within the elastomeric member334. The elastomeric member334can be made of an elastic material such as silicone. The opening348of the retention portion346can stretch and/or compress to accommodate an elongate member inserted into the retention portion346. The retention portion346can be configured to form a friction fit with an elongate member inserted into the opening348of the retention portion346. The friction fit between the retention portion346and the elongate member can resist distal movement of the elongate member relative to the retention portion346until the elongate member is subjected to sufficient tension in the distal direction.

FIG.16depicts a cross-sectional view of a non-limiting alternative embodiment of the locking assembly300′ that includes the housing301′ but not include an elastomeric member334′. The housing301′ can be substantially similar to that described above except without a recessed portion configured to receive the elastomeric member. In this embodiment, the locking assembly300′ can include a retention portion346′ which can include the second lumen312′. The second lumen312′ can have a uniform cross-sectional area or a non-uniform cross-sectional area (e.g., a constriction of the second lumen312′). A distal portion374′ of the second lumen312′ can have a width376′ that is greater than a width380′ of an intermediate portion382′ of the second lumen312′. The second lumen312′ may include a proximal portion384′ that is proximal of the intermediate portion382′ of the second lumen312′. The proximal portion384′ can have a width386′ that is greater than the width380′ of the intermediate portion382′. The operation of the retention portion346′ is discussed below.

FIGS.17A and17Bschematically illustrate a method of releasing the guidewire from the locking assembly300that can be used in connection with both the locking assemblies with and without the elastomeric member (shown inFIGS.15and16). Although these figures illustrate the second lumen312″ having a generally uniform diameter, the diameter may vary as shown inFIG.16.FIG.17Adepicts a non-limiting exemplary embodiment of the locking assembly300″ with a distal portion194b(also called the locking portion) of the contralateral guidewire194inserted into the second lumen312″ of the locking assembly300″. When the contralateral guidewire194is inserted into the locking assembly300″, general advancement and retraction of the contralateral guidewire194without the appropriate vertical force and/or actuation will not release the contralateral guidewire194from the locking assembly300″.

The contralateral guidewire194can include multiple regions, with each region having a different stiffness. For example, the stiffness of the locking portion194bof the contralateral guidewire194can be selected to be higher than the stiffness of a proximal portion194a(also called the floppy region) of the contralateral guidewire194.194194194194By designing the floppy region194ato have a low stiffness, the a proximal portion194aof the contralateral guidewire194will be sufficiently flexible to avoid causing damage to surrounding tissue. The tensile strength of the floppy region194acan be greater than about 1 lbf, greater than about 2 lbf, greater than about 6 lbf, and greater than about 8 lbf.

The locking portion194bof the contralateral guidewire194can extend from the floppy region194aof the contralateral guidewire194at an interface406″. The length410″ of the locking portion194bcan be selected from different lengths. In some embodiments, the length of the locking portion194b″ can be between about 0.3 and 0.8 cm. Additionally or alternatively, the insertion depth of the locking portion194binto the second lumen312″ can be adjusted. The contralateral guidewire194and the locking assembly300″ may be tailored so that the interface406″ can be located distal, proximal, or co-planar to the distal face302″ of the locking assembly300″.

During use, a user may pull on the contralateral guidewire194, creating a tension412″ in the contralateral guidewire194, thereby causing the contralateral guidewire194to bend in the proximal direction, as illustrated inFIG.17A. Additionally or alternatively, a user may push on the contralateral guidewire194, causing a compressive force414″ that buckles the contralateral guidewire194in the distal direction, thereby pushing the locking portion194binto the retention portion346″. The locking assembly300″ can include a protrusion332″ that provides strain relief to the contralateral guidewire194when the contralateral wire194bends back in the proximal direction. The position of the interface406″ relative to the distal face302″ of the locking assembly300″ can be selected so that as the tension412″ pulls on the interface406″, the locking portion194bof the contralateral guidewire194is retained against a lateral surface416″ of the retention portion346″, thereby preventing the contralateral guidewire194from decoupling from the locking assembly300″. The clearance between the locking portion194band the lateral surface416″ can also be selected to further define the tension412″ required to decouple the contralateral guidewire194from the locking assembly300″. The locking assembly300″ can be configured to release the locking portion194bof the contralateral guidewire194when a force is applied to an intermediate portion of the contralateral guidewire194at an angle of less than or equal to about 60 degrees from the locking portion194bof the contralateral guidewire194and/or at least about 45 degrees from the locking portion194b″ of the contralateral guidewire194″.

FIG.17Bshows an illustrative embodiment of a locking assembly300″ that is configured to release the contralateral guidewire194upon a release member311(e.g., pigtail catheter) contacting with the locking assembly300″ and applying a vertical force to draw the locking portion194bof the contralateral guidewire194out of the retention portion346″. In the non-limiting exemplary locking assembly300″ depicted inFIG.17B, the release member311can be a release sheath that is configured to be disposed over the contralateral guidewire194. The release member311may completely circumferentially surround the contralateral guidewire194, or the release member311may only partially circumferentially surround the contralateral guidewire194. The release member311may be composed of plurality of segments. The segments may be identical to one another or different from one another. Some, all, or no segments may completely circumferentially surround the contralateral guidewire194while some, all, or no other segments only partially surround the contralateral guidewire194. The segments may be separated from one another by one or more hinge points. The hinge points may be configured to allow the segments to bend, flex, or pivot relative to one another.

The release member311can be introduced at the contralateral access site by passing the distal end of the release member311over the proximal end of the contralateral guidewire194. The release sheath420″ can be advanced over the contralateral guidewire194until the distal face of the release member311engages the distal face302″ of the locking assembly300″. The outer diameter of the distal face of the release member311can be selected so that the distal face abuts against the distal face302″ of the locking assembly. As a user applies a compressive force414″ to the release member311and contralateral guidewire194, the release member311buckles in the distal direction. As the release member311buckles (loops, forms a U-shape, or otherwise bends) in the distal direction, the portion of the contralateral guidewire194that distally extends from the retention member346″ of the locking assembly300″ is aligned to be substantially perpendicular to the distal face302″ of the locking assembly300″. A user may now apply tension412″ to the contralateral guidewire194. Once a distally extending portion of the contralateral guidewire194is longitudinally aligned with the retention member346″, the194the contralateral guidewire194is released from the retention member346″. The locking assembly300″ can be configured to retain the contralateral guidewire194until a vertical force of at least 0.1 lbf (or at least about 0.5 lbf, at least about 1.0 lbf, or otherwise) is applied to the contralateral guidewire194.

The reversible coupling of the contralateral guidewire194to the locking assembly300can be accomplished by alternative embodiments that are within the scope of the present disclosure. For example, the locking assembly300″ depicted inFIGS.17A-Bcan include an elastomeric member334, as discussed above. Additionally or alternatively, the locking assembly300can include any of the features depicted in the alternative embodiments depicted inFIGS.18A-R.

FIG.18Adepicts an embodiment where the locking portion194bof the contralateral guidewire194is retained by wrapping the locking portion194bof the contralateral guidewire194over the main branch portion52of the graft50. The locking portion194bcan be secured to the outer surface of the main branch portion52by a sheath (not shown) that is deployed by a suture (not shown) as described above for the deployment of the main branch portion52of the graft50. The locking portion194bmay be larger in diameter, longer, and/or more rigid than remaining portions of the contralateral guidewire194. The sheath that secures the locking portion194bcan be the main branch sheath186or a sheath different from the main branch sheath186.

FIG.18Bdepicts an embodiment of the locking assembly300that can have a track428configured to retain the locking portion194bof the contralateral guidewire194. The locking portion194bmay be larger and/or more rigid than a remaining portion of the contralateral guidewire194to help retain the locking portion194bwithin the track428. The track428may be an open faced channel having a variable width so that when tension is applied to the contralateral guidewire194the locking portion194bis drawn up into a necked region of the track428, thereby constraining the locking portion194bfrom escaping the track428. Additionally or alternatively, a region of the track428may be an open faced channel having an enlarged region where the width of the track428is larger than the width of the locking portion194b. A user may free the contralateral guidewire194from the locking assembly300by advancing the locking portion194bof the contralateral guidewire194until the locking portion194bis aligned with the enlarged region of the track428, thereby allowing the locking portion194bto escape the track428.

FIG.18Cdepicts an embodiment of the locking assembly300that has a retaining wire430. The retaining wire430can be configured to hold the contralateral guidewire194against the distal face302of the locking assembly300, thereby keeping the locking portion194bwithin the retention portion346of the locking assembly300. The retention portion346can be a groove on the side of the housing301of the locking assembly300. The retention portion346may be a pocket432that is surrounded by the housing301. The width of the groove or pocket432may vary as described above. The retaining wire430can be configured to be withdrawn from the locking assembly300, thereby allowing the locking portion194bto potentially release from the pocket432.

FIG.18Ddepicts an embodiment of the locking assembly300that has a clamp434. The top portion436of the clamp434may be pulled against the bottom portion438of the clamp434by a spring440that is connected to the top portion436by a tension element442. The contralateral guidewire194may be coupled to the locking assembly300by virtue of being compressed between the top and bottom portions436,438of the clamp434. A user may activate a trigger444to compress the spring440reducing the tension element, thereby reducing the compressive force between the top and bottom portions436,438of the clamp434and allowing the contralateral guidewire194to decouple from the locking assembly300. In other embodiments, the tension in the spring440may be released by moving the trigger444or by releasing the tension on the spring440.

FIG.18Edepicts an embodiment of the locking assembly300having a duckbill valve446. The duckbill valve446can be configured to retain a locking portion194bat the distal end of the contralateral guidewire194. The locking portion194bmay be larger and/or more rigid than a remaining portion of the contralateral guidewire194. A user may decouple the contralateral guidewire194from the locking assembly300by advancing the contralateral guidewire194to allow the locking portion194bto escape the duckbill valve446.

FIG.18Fdepicts an embodiment of the locking assembly300configured to retain a bead448attached to the contralateral guidewire194. The bead448can interface with (e.g., by bonding) the contralateral guidewire194. As shown inFIG.18F, the bead448can sit within a channel445that has a narrow proximal portion and a wider distal portion. The narrow proximal portion of the channel445can be configured to prevent the bead448from being pulled proximally through the channel. The wider portion of the channel can have an overhang447that can be configured to prevent the bead448from leaving the channel445unless the bead448is advance sufficiently far distally to clear the overhang447.

FIG.18Gdepicts an embodiment of the locking assembly300having a plastic retention member390(e.g., soft wing) that can be located within the main branch portion52of the graft50. The plastic retention member390can interface (e.g., by friction, press fit, molded, adhered, thermally bonded, mechanically locked, otherwise secured) with the central tube170. The contralateral guidewire194can extend distally through the graft50, pass over or through a housing member and bend proximally back into the graft50to terminate at the plastic retention member390. The locking portion194bof the contralateral guidewire194can be configured to be retained by the plastic retention member390as described above inFIG.18B.

FIG.18Hdepicts an embodiment of the locking assembly300having a wrapper450. The wrapper450can enclose at least a portion of the housing301of the locking assembly300. The wrapper450can be configured to restrain the locking portion194bof the contralateral guidewire194within a channel452formed in the side of the housing301. The wrapper450can be removed by a control suture454, thereby allowing the locking portion194bto escape the channel452.

FIG.18Idepicts an embodiment of the locking assembly300having a rigid sheath456. The rigid sheath456can be configured to press the contralateral guidewire194against an abutment458, thereby locking the contralateral guidewire194to the locking assembly300. The contralateral guidewire194may be decoupled from the locking assembly300by proximally withdrawing the rigid sheath456or distally advancing the abutment458. A control rod460attached to the abutment458can allow a user to distally advance the abutment458. The locking portion194bmay be larger and/or more rigid than a remaining portion of the contralateral guidewire194locking portion

FIG.18Jdepicts an embodiment of the locking assembly300having a curved groove462. The curved groove462may be S-shaped, U-shaped, sinusoidal, zig-zag-shaped or combinations thereof. The curved groove462may be formed in the outer surface of the housing301of the locking assembly300described above. The contralateral guidewire194may include a locking portion194bthat has a width or length that prevents the locking portion194bfrom being pulled through the curved groove462. The locking assembly300can be configured so that when the contralateral guidewire194is advanced distally the locking portion194bof the contralateral guidewire194may peel out of the housing301, thereby freeing the contralateral guidewire194from the locking assembly. Additionally or alternatively, the locking assembly300may be configured so that a release member311is advanced over the contralateral guidewire194to assist in freeing the contralateral guidewire194from the locking assembly300.

FIG.18Kdepicts an embodiment of the locking assembly300having an extended portion464of the contralateral branch sheath190. The extended portion464may wrap around a portion of the locking assembly300, thereby retaining the locking portion194bof the contralateral guidewire194within a pocket432of the locking assembly300. The extended portion464may be held closed by a suture. The suture can be coupled to the contralateral branch sheath190. The suture can be configured to separate the extended portion464from the housing301as the contralateral branch sheath190is proximally withdrawn, thereby freeing the locking portion194bof the contralateral guidewire194from the locking assembly300.

FIG.18Ldepicts an embodiment of the locking assembly300having a contralateral guidewire194that extends into the ipsilateral branch portion54of graft50. The ipsilateral limb pinches, compresses, or otherwise provides friction such that the guidewire when inadvertently advanced does not disconnect from the catheter until the ipsilateral branch portion is deployed. The contralateral guidewire194may extend through a bead448. The bead448may be configured to be retained within a channel452formed in the side of or through the housing301of the locking assembly300as described above.

FIG.18Mdepicts an embodiment of the locking assembly300having a folded portion194cof the contralateral guidewire194that is folded over the ipsilateral branch portion54of the graft50. The folded portion194cmay be held against an outer surface of the ipsilateral branch portion54by the ipsilateral branch sheath188. Retraction of the ipsilateral branch sheath188may then free the folded portion194c, thereby allowing the contralateral guidewire194to be removed from the locking assembly300.

FIG.18Ndepicts an embodiment of the locking assembly300having ipsilateral locking member468. The ipsilateral locking member468can include a channel452configured to retain a locking portion194bor bead448that is coupled to the contralateral guidewire194, as discussed above.

FIG.18Odepicts an embodiment of the locking assembly300having a bent channel470. The bent channel470can be configured so that the locking portion194bof the contralateral guidewire194is unable to navigate through the bent channel470. The locking portion194bof the contralateral guidewire194can be decoupled for the locking assembly300by advancing the locking portion194bproximally through the bent channel470.

FIG.18Pdepicts an embodiment of the locking assembly300having a ball feature472at the locking portion194bof the contralateral guidewire194. The ball feature472can be configured to function similar to the bead448described above forFIG.18F. The ball feature472may be configured to be too large to pass proximally through the channel of the locking assembly300. The ball feature can be configured so that the locking portion194bis freed from the locking assembly when the ball feature is advanced distally, thereby allowing the contralateral guidewire194to peel out of the channel in the locking assembly300.

FIG.18Qdepicts an embodiment of the locking assembly300having a segmented locking channel474. The segmented locking channel474may include a plurality of segments476a, b, each having a groove475formed into the surface of the segment476a,b. The segments476a,bmay be joined together by a coupling member478. The contralateral guidewire194may navigate through the segmented locking channel474. The locking portion194bof the contralateral guidewire194may be retained within a pocket432that is formed in one of the segments476bof the plurality of segments476a,b.

FIG.18Rdepicts an embodiment of the locking assembly300having a magnetic component480. The magnetic component480can be disposed within the pocket432formed into the housing301of the locking assembly300. The locking portion194bof the contralateral guidewire194may include magnetic material that causes the locking portion194bto be magnetically attracted to the magnetic member180, thereby resisting upward forces412on the contralateral guidewire194from decoupling the locking portion194bof the contralateral guidewire194from the locking assembly300.

FIG.19depicts a non-limiting exemplary embodiment of the contralateral guidewire194. The contralateral guidewire194can be configured to include multiple regions that are joined together. The contralateral guidewire194can have a first end194fand a second end194g. The serial arrangement of the multiple regions of the contralateral guidewire can be varied according to the needs of the user. The serial arrangement of the regions of the contralateral guidewire194shown inFIG.19is illustrative only and not to be taken as limiting. The contralateral guidewire194can include a wire core, shrink tube made of suitable material (e.g., PTFE), adhesive, alloys containing platinum, and combinations thereof. The platinum alloys can contain 90% platinum and 10% irradium, or 92% platinum and 8% tungsten.

The contralateral guidewire194may include a distal coil made of wire containing platinum, e.g., at least about 90% platinum, at least about 92% platinum, at least about 95% platinum, or at least about 99% platinum. In some embodiments, the contralateral guidewire194can be constructed from about 92% platinum and 8% tungsten. The distal coil may be made of wire having an outer diameter of 0.003 inches. The distal coil may have a pitch of 0.003 inches. The distal coil may have a coil outer diameter of 0.025 inches. The distal coil may have a coil length of 8.0 cm with a tolerance of 0.3 cm.

The contralateral guidewire194may include a proximal coil made of wire containing 92% platinum and 8% tungsten. The proximal coil may be made of wire having an outer diameter of 0.003 inches. The proximal coil may have a pitch of 0.003 inches. The proximal coil may have a coil outer diameter of 0.025 inches. The proximal coil may have a coil length of 15.0 cm with a tolerance of 0.3 cm.

A first region194h(denoted as having a diameter of P inFIG.19) of the contralateral guidewire194can have a diameter of 0.0160 inches with a tolerance 0.0002 inches. The first region194hcan have a length of 0.3 cm with a tolerance of 0.1 cm. A second region194i(denoted as having a diameter of R inFIG.19) of the contralateral guidewire194can have a smaller diameter than the first region194h, e.g., less than or equal to one-half the diameter of the first region194h. For example, the diameter of the second region194ican be about 0.0080 inches with a tolerance 0.0002 inches. The second region194ican be longer than the first region194h. For example, the second region194ican have a length of 10.4 cm with a tolerance of 0.1 cm. A third region194j(denoted as having a diameter of V inFIG.19) of the contralateral guidewire194can have a larger diameter than the first and second regions194h,194i. For example, the diameter of the third region194jcan be about 0.0174 inches with a tolerance 0.0002 inches. The third region194jcan be longer than the first region194hand/or shorter than the second region194i. For example, the third region194jcan have a length of 1.0 cm with a tolerance of 0.1 cm. A fourth region194k(denoted as having a diameter of K inFIG.19) of the contralateral guidewire194can have a diameter greater than the first, second, and third regions194h,194i,194j. For example, the fourth region194kcan have a diameter of about 0.0300 inches with a tolerance 0.0003 inches. A fifth region194l(denoted as having a diameter of H inFIG.19) of the contralateral guidewire194can have a diameter that is less than the diameter of the fourth region194k, but greater than the diameter of the first, second, and third regions194h,194i,194j. For example, the diameter of the fifth region194lcan be about 0.0210 inches with a tolerance 0.0002 inches. The fifth region194lcan be greater than each of the preceding regions194h,194i,194j,194k. For example, the fifth region194lcan have a length of 40.8 cm with a tolerance of 0.5 cm. A sixth region194m(denoted as having a diameter of U inFIG.19) of the contralateral guidewire194can have a diameter that is about the same as the diameter of the third region194j. For example, the diameter of the sixth region194mcan be about 0.0174 inches with a tolerance 0.0002 inches. The sixth region194mcan be shorter than the can have a length of 0.8 cm with a tolerance of 0.1 cm. A seventh region194n(denoted as having a diameter of B inFIG.19) of the contralateral guidewire194can have a diameter that is about the same as the second region194i. The diameter of the seventh region194nmay provide the smallest diameter of the contralateral guidewire194. For example, the seventh region194ncan have a diameter of 0.0080 inches with a tolerance 0.0002 inches. The seventh region can have a length of 5.2 cm with a tolerance of 0.1 cm. An eighth region194o(denoted as having a diameter of G inFIG.19) of the contralateral guidewire194can have a diameter that is about the same as the diameter of the first region194h. For example, the eighth region194ocan have a diameter of about 0.0160 inches with a tolerance 0.0002 inches. The eighth region194ocan have a length of 0.5 cm with a tolerance of 0.1 cm. The contralateral guidewire194may include transition regions that soften diameter changes in the contralateral guidewire194. The transition regions may have a tapering angle that is formed between the longitudinal axis of the contralateral guidewire194and the outer wall of the transition region. The tapering angle of the transition regions can range between 10 and 60 degrees.

Terminology

While the above description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made without departing from the spirit of the disclosure. Additionally, the various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure.

As will be recognized, certain embodiments described herein may be embodied within a form that does not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from others. The scope of the inventions is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. For example, while the delivery system is described with respect to deploying a bifurcated stent in the abdominal aortic, it is further envisioned that the delivery system could be used to deliver a prosthesis having a main portion and at least one branch portion, or alternatively a prosthesis having only a straight, main branch portion, to other branched intravascular vessels (e.g., the thoracic aorta and a cardiac artery) and leave a guidewire positioned through the expanded prosthesis.

The term “guidewire” is to be interpreted broadly and may include, in addition to its ordinary and customary meaning to a person of ordinary skill in the art, any elongate member. Although the disclosure herein describes a locking assembly for reversibly coupling a guidewire to a delivery system, the locking assembly can also be used to reversibly couple any elongate structure to the delivery system, catheter, or otherwise.

As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the delivery system. Thus, proximal refers to the direction of the control end of the delivery system and distal refers to the direction of the distal tip.

Note that the terms “first” and “second” branch portion can be used interchangeably and to refer to any branch vessel in the body, including but not limited to the ipsilateral vessel, the contralateral vessel, radial vessels, and subclavian vessels. Accordingly, in some embodiments, the “first” branch portion can refer to any branch portion including but not limited to the vessels set forth above. Similarly, the “second” branch portion can refer to any branch portion including but not limited to the vessels set forth below.

Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.

The terms “approximately,” “about,” “generally,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of the stated amount. As another example, in certain embodiments, the terms “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees.

The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “approximately 2 in.” includes “2 in.”

Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that, achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “releasing the delivery system from the locked configuration” include “instructing release of the delivery system from the locked configuration.”

EXAMPLE EMBODIMENTS

The following example embodiments identify some possible permutations of combinations of features disclosed herein, although other permutations of combinations of features are also possible.

1. A locking assembly for releasably coupling a first elongate structure to a second elongate structure, the locking assembly comprising:a housing comprising a proximal end, a distal end, and a lateral wall portion;a first lumen extending from the proximal end of the housing to the distal end of the housing and along a longitudinal axis of the locking assembly, the first lumen being configured to receive the first elongate structure;a second lumen extending from the distal end of the housing, a diameter of the second lumen being less than a diameter of the first lumen, the second lumen being configured to receive the second elongate structure; anda recessed portion extending at least partially through the housing, the recessed portion comprising at least one opening in the lateral wall portion of the housing.

2. The locking assembly of Embodiment 1, further comprising an elastomeric member in the recessed portion, the elastomeric member configured to retain the second elongate structure when the second elongate structure extends through the second lumen.

3. The locking assembly of Embodiment 2, wherein at least a portion of an outer surface of the elastomeric member is substantially flush with an outer surface of the lateral wall portion of the housing.

4. The locking assembly of Embodiment 2, or 3 wherein the elastomeric member comprises an opening at least partially aligned with the second lumen.

5. The locking assembly of Embodiment 4, wherein the opening comprises a diameter that is smaller than the diameter of the second lumen.

6. The locking assembly of any one of Embodiments 2 to 5, wherein the elastomeric member comprises silicone.

7. The locking assembly of any one of the preceding Embodiments, wherein a proximal portion of the housing is tapered.

8. The locking assembly of any one of the preceding Embodiments, further comprising a protruding portion extending along at least a portion of an outer periphery of a distal portion of the housing.

9. The locking assembly of Embodiment 8, wherein the second lumen is positioned between the first lumen and the protruding portion.

10. The locking assembly of any one of the preceding Embodiments, wherein the second lumen comprises a proximal portion, a distal portion, and an intermediate portion therebetween, a diameter of the intermediate portion being less than a diameter of the proximal portion and the distal portion.

11. A locking assembly for coupling a contralateral guidewire to an ipsilateral catheter, the locking assembly comprising:an anchoring portion configured to engage the ipsilateral catheter; andan interlock portion configured to retain a distal portion of the contralateral guidewire when the contralateral guidewire is advanced or retracted unless a vertical force of at least 0.1 lbf is applied to the contralateral guidewire.

12. The locking assembly of Embodiment 11, wherein the interlock portion comprises a lumen, the lumen being shaped to retain the contralateral guidewire when the contralateral guidewire is retracted.

13. The locking assembly of Embodiment 12, wherein the lumen comprises a distal portion, a proximal portion, and an intermediate portion therebetween, a diameter of the intermediate portion being less than a diameter of the distal portion and a diameter of the proximal portion.

14. The locking assembly of any one of Embodiments 11 to 13, further comprising a retention member configured to frictionally retain the guidewire when the guidewire is advanced.

15. The locking assembly of Embodiment 14, wherein the retention member comprises an elastomeric material.

16. The locking assembly of Embodiment 14 or 15, wherein the retention member comprises an opening configured to receive the contralateral guidewire.

17. The locking assembly of any one of Embodiments 11 to 16, wherein the interlock portion is configured to release the contralateral guidewire when a force is applied to an intermediate portion of the contralateral guidewire at an angle of less than or equal to about 60 degrees from the distal portion of the guidewire in the interlock portion.

18. A system for reversibly securing a first elongate member to a second elongate member, the system comprising:a first elongate member;a second elongate member comprising a proximal portion and a distal portion; anda locking assembly fixed to the first elongate member, the locking assembly comprising:a housing comprising a proximal end and a distal end;a lumen extending from the distal end of the housing and through at least a portion of the housing, the second lumen being configured to receive the second elongate member from a distal side of the locking assembly;a recessed portion extending at least partially through the housing; andan elastomeric member in the recessed portion, the elastomeric member configured to retain the distal portion of the second elongate member when the second elongate member extends through the second lumen.

19. The system of Embodiment 18, wherein the second elongate member comprises a first region and a second region, the first region having a first stiffness, the second region having a second stiffness, the first stiffness being greater than the second stiffness.

20. The system of Embodiment 19, wherein the first region is distal to the second legion.

21. The system of Embodiment 19, wherein the first region is at a distal end of the second elongate member.

22. The system of Embodiment 18 or 19, further comprising a sheath configured to be advanced along the second elongate member and disengage the second elongate member from the recessed portion.

23. The system of Embodiment 18 to 22, wherein the second elongate member is a guidewire.

24. The system of any one of Embodiments 18 to 23, wherein the first elongate member is a catheter.

25. The system of any one of Embodiments 18 to 24, wherein the second lumen comprises a proximal portion, a distal portion, and an intermediate portion therebetween, a diameter of the intermediate portion being less than a diameter of the distal portion and a diameter of the proximal portion.

26. The system of any one of Embodiments 18 to 25, wherein the recessed portion comprises at least one opening in a lateral wall of the housing.

27. The system of any one of Embodiments 18 to 26, wherein the elastomeric member comprises an opening at least partially aligned with the second lumen.

28. The locking assembly of Embodiment 27, wherein the opening comprises a diameter that is smaller than the diameter of the second lumen.

29. The locking assembly of any one of Embodiments 18 to 28, wherein the elastomeric member comprises silicone.

30. The locking assembly of any one of Embodiments 18 to 29, further comprising a protruding portion extending along at least a portion of an outer periphery of a distal portion of the housing.

31. A method for releasing a contralateral guidewire from an ipsilateral catheter, the method comprising:advancing a delivery system in a locked configuration, the delivery system comprising a locking assembly fixed to the ipsilateral catheter, the locking assembly comprising an interlock portion configured to retain the guidewire when the delivery system is in the locked configuration, a distal end of the guidewire being introduced into the interlock portion from a distal side of the locking assembly such that the guidewire comprises a bend when the delivery system is in the locked configuration, the bend being positioned between a proximal portion of the guidewire and the distal portion of the guidewire; andreleasing the delivery system from the locked configuration to the unlocked configuration by advancing a release catheter along the guidewire.

32. The method of Embodiment 31, wherein in the locked configuration, the interlock portion is configured to retain the guidewire when the guidewire is retracted.

33. The method of Embodiment 31 or 32, wherein before advancing the release catheter, the interlock portion is configured to retain the guidewire when the guidewire is advanced.

34. The method of any one of Embodiments 31 to 33, wherein releasing the delivery system comprises applying a force to the guidewire at an angle of less than or equal to about 60 degrees from a longitudinal axis of the locking assembly.