Patent Description:
It is often desirable to use multiple guidewires in various medical procedures involving diseased bifurcated patient lumens. For example, when utilizing stent deployment devices within bifurcated lumens, a first guidewire would be used to access a first lumen branch while a second guidewire would be used to access a second lumen branch. At least one stent may be collapsed and inserted within a delivery device, such as a catheter. The delivery device may be advanced along the respective guidewires to the diseased portion of the patient lumen. Once at the desired position for stent deployment in the bifurcated patient lumen, the stent may be deployed from the delivery device and expanded.

<CIT> discloses a medical device delivery system that includes a retention sheath having a proximal portion and a bi-furcated distal portion having first and second sheath branch portions. The proximal ends of the sheath branch portions are joined together at a sheath branch junction. The system also includes an inner catheter disposed within the retention sheath. The inner catheter includes a proximal portion and a bi-furcated distal portion with first and second catheter branch portions. The proximal ends are joined together at a catheter branch junction. When the sheath is in an initial position, the catheter branch junction is displaced proximally from the sheath branch junction by a distance that is greater than or equal to the larger of a length of a first medical device and the length of a second medical device.

<CIT> discloses a stent deployment catheter that includes an elongate catheter shaft having a proximal end, a distal end, and a lumen therethrough. A first stent sheath has a lumen therethrough and an elongate longitudinal opening therein. A second stent sheath also has a lumen therethrough and an elongate longitudinal opening therein. The first and second stent sheaths are disposed at the distal end of the catheter shaft. An elongate actuator is coupled to the first and second stent sheaths and extends to a proximal region of the catheter shaft. The actuator is longitudinally movable relative to the catheter shaft.

The invention is defined in the independent claim, with optional features being defined in the dependent claims. In an aspect, a bifurcated implant delivery system is provided. A shaft has a shaft proximal end having at least two shaft proximal openings. A shaft distal end has at least two shaft branches longitudinally extending from a shaft body distal end. Each of the shaft branches has a shaft open tip. A shaft body longitudinally extends between the shaft proximal end and the shaft distal end. The shaft has at least one shaft lumen. The at least one shaft lumen longitudinally extends between a respective shaft proximal opening and at least one respective shaft open tip. A reinforcing element longitudinally extends from the shaft body distal end. The reinforcing element is configured to directly contact a bifurcated expandable implant to maintain the bifurcated expandable implant in a predetermined position. An outer sheath has an outer sheath proximal end having an outer sheath proximal opening. An outer sheath distal end has at least one outer sheath open tip. An outer sheath lumen longitudinally extends between the outer sheath proximal opening and the at least one outer sheath open tip. The outer sheath lumen is for selectively holding at least a portion of the shaft and a bifurcated expandable implant therein.

For a better understanding, reference may be made to the accompanying drawings, in which <FIG> illustrate an embodiment in accordance with the invention, and:.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the present disclosure pertains.

As used herein, the term "patient" may refer to any warm-blooded organism including, but not limited to, human beings, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farm animals, livestock, birds, etc..

As used herein, the term "user" may be used interchangeably to refer to an individual who prepares for, assists, and/or performs a procedure.

As used herein, the singular forms "a," "an" and "the" may include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," as used herein, may specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

As used herein, the term "and/or" may include any and all combinations of one or more of the associated listed items.

As used herein, phrases such as "between X and Y" may be interpreted to include X and Y.

It will be understood that when an element is referred to as being "on," "contacting," etc., another element, it may be directly on or contacting the other element or intervening elements may also be present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may not have portions that overlap or underlie the adjacent feature.

Spatially relative terms, such as "over" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the Figures. It will be understood that the spatially relative terms may encompass different orientations of a device in use or operation, in addition to the orientation depicted in the Figures. For example, if a device in the Figures is inverted, elements described as being "over" other elements or features would then be oriented "under" than the other elements or features.

It will be understood that, although the terms "first," "second," etc. may be used herein to describe various elements, these elements should not be limited by these terms. Thus, a "first" element discussed below could also be termed a "second" element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or Figures unless specifically indicated otherwise.

An implant delivery system <NUM> is disclosed. The implant delivery system <NUM> includes a shaft <NUM> having one of any number of alternate configurations, some of which will be discussed below. As shown in <FIG>, the shaft <NUM> has a shaft proximal end <NUM>, a shaft distal end <NUM>, and a shaft body <NUM> longitudinally extending between the shaft proximal and distal ends <NUM>, <NUM>. The term "longitudinal" is used herein to indicate a substantially horizontal direction, in the orientation of <FIG>. The shaft proximal end <NUM> has at least two shaft proximal openings <NUM> (shown here as shaft proximal openings 110a and 110b). The shaft distal end <NUM> has at least two shaft branches <NUM> (shown here as shaft branches 112a and 112b) that longitudinally extend from a shaft body distal end <NUM>. Each of the shaft branches 112a, 112b has a shaft open tip <NUM> (shown here as shaft open tips 116a and 116b) and may have a nosecone <NUM> (shown here as nosecones 118a and 118b) at a respective shaft branch distal end <NUM> (shown here as shaft branch distal ends 120a and 120b). A "nosecone," as used herein, is a structure resembling a cone, or, in other words, resembling a solid bounded by a circular or other closed plane base and the surface formed by line segments joining every point of the boundary of the base to a common vertex.

Each of the nosecones 118a, 118b may point, or narrow, in a longitudinally distal direction (shown as an arrow "X" in <FIG>). Each of the nosecones 118a, 118b may be configured to substantially prevent the egress of a bifurcated expandable implant M mounted circumferentially on the shaft <NUM> from a desired position on the shaft <NUM>, such as on at least one of the shaft body <NUM> and the at least two shaft branches 112a, 112b. The term "circumferentially" is defined herein as at least partially surrounding the external boundary or surface of a figure or object. The bifurcated expandable implant M may be a bifurcated stent, a bifurcated stent-graft, a bifurcated embolization plug, a bifurcated shunt closure device, any bifurcated self-expandable device, any other bifurcated expandable device, or any combination thereof. Each of the nosecones 118a, 118b may also, or instead, be used for a smooth atraumatic transition of the implant delivery system <NUM> into a target patient tissue site T of a patient lumen L.

As shown in <FIG>, each of the nosecones 118a, 118b may have at least one elastic skirt <NUM> (shown here as elastic skirts 222a and 222b) that longitudinally extends in the proximal direction (shown as an arrow "Y" in <FIG>). Each of the elastic skirts 222a, 222b may be for at least partially selectively restricting at least a portion of a respective expandable implant branch MB (shown here as expandable implant branches MB-a and MB-b) from fully expanding, and/or moving toward an expanded condition, from a collapsed condition when the bifurcated expandable implant M is operatively joined to the shaft <NUM>, as will be discussed in more detail below. Each of the elastic skirts 222a, 222b is capable of moving between a collapsed condition (<FIG>) and an expanded condition (<FIG>).

As shown in <FIG>, the shaft <NUM> may have a shaft outer surface <NUM> and has at least one shaft lumen <NUM> (shown here as shaft lumens 126a and 126b). At least a portion of the shaft outer surface <NUM> may be configured for selectively circumferentially mounting the bifurcated expandable implant M thereon, as will be described below. The shaft lumen <NUM> longitudinally extends between a respective shaft proximal opening <NUM> and each of the shaft open tips 116a, 116b. In the case of a shaft <NUM> having at least two shaft lumens 126a, 126b, each of the shaft lumens 126a, 126b may longitudinally extend between a respective shaft proximal opening 110a, 110b and a respective shaft open tip 116a, 116b. Instead of extending to a respective shaft proximal opening 110a, <NUM>0b, each of the shaft lumens 126a, 126b of a shaft <NUM> having at least two shaft lumens 126a, 126b may extend between a respective shaft open tip 116a, 116b and at least one shaft proximal opening (shown here as two shaft proximal openings 110a and 110b), which may be common/shared or individual per shaft lumen.

The shaft <NUM> has a reinforcing element <NUM> that longitudinally extends from the shaft body distal end <NUM>. The reinforcing element <NUM> may both longitudinally extend between the shaft proximal end <NUM> and the shaft body distal end <NUM>, and longitudinally extend from the shaft body distal end <NUM>. When a bifurcated expandable implant M is operatively joined to the shaft <NUM>, at least a portion of an expandable implant transition portion MT may at least partially contact a reinforcing element distal end <NUM>. The contact between the expandable implant transition portion MT and the reinforcing element distal end <NUM> may at least partially maintain the expandable implant transition portion MT at a patient lumen transition portion LT during operation of the implant delivery system <NUM>, as will be described below. <FIG>, <FIG>, <FIG>, and <FIG> depict cross-sectional views of various points along the shaft <NUM>, to show the structural features of the shaft <NUM>, as depicted in <FIG>, <FIG>, <FIG>, and <FIG>, respectively.

The implant delivery system <NUM> includes an outer sheath <NUM> having one of any number of alternate configurations, some of which will be discussed below. As shown in <FIG>, the outer sheath <NUM> has an outer sheath proximal end <NUM>, an outer sheath distal end <NUM>, and an outer sheath body <NUM> longitudinally extending between the outer sheath proximal and distal ends <NUM>, <NUM>. The outer sheath proximal end <NUM> has an outer sheath proximal opening <NUM>. The outer sheath distal end <NUM> has at least one outer sheath open tip <NUM> (shown here as outer sheath open tips 540a and 540b). The outer sheath <NUM> may have an outer sheath outer surface <NUM> and has an outer sheath lumen <NUM>. The outer sheath lumen <NUM> longitudinally extends between the outer sheath proximal opening <NUM> and the at least one outer sheath open tip 540a, 540b. The outer sheath lumen <NUM> is at least partially configured for selectively holding at least a portion of the shaft <NUM> and a bifurcated expandable implant M therein, as will be described below.

As shown in <FIG>, the outer sheath distal end <NUM> may have at least two outer sheath branches <NUM> (shown here as outer sheath branches 546a and 546b). The number of outer sheath branches 546a, 546b may directly correspond to at least one of the number of shaft branches 112a, 112b, the number of expandable implant branches MB-a, MB-b of a bifurcated expandable implant M, and the number of patient lumen branches LB (shown here as patient lumen branches LB-a and LB-b) in a bifurcated patient lumen L. Each of the outer sheath branches 546a, 546b may have an outer sheath open tip 540a, 540b. When the outer sheath <NUM> has at least two outer sheath branches 546a, 546b, the outer sheath lumen <NUM> longitudinally extends between the outer sheath proximal opening <NUM> and each of the outer sheath open tips 540a, 540b. In such case, the outer sheath lumen <NUM> is configured to at least partially selectively prevent at least one of an expandable implant body MO and expandable implant branches MB-a, MB-b from expanding from a collapsed condition when the bifurcated expandable implant M is at least partially disposed within the outer sheath lumen <NUM>.

Each of the outer sheath branches 546a, 546b may have an outer sheath branch open slit <NUM> (shown here as outer sheath branch open slits 548a and 548b). Each of the outer sheath branch open slits 548a, 548b may longitudinally extend between a respective outer sheath branch proximal end <NUM> (shown here as outer sheath branch proximal ends 550a and 550b) and a respective outer sheath open tip 540a, 540b. Each of the outer sheath branch open slits 548a, 548b may laterally face toward an outer sheath longitudinal axis OL. Each outer sheath branch open slit 548a, 548b has an outer sheath branch open slit first surface <NUM> (shown here as outer sheath branch open slit first surfaces 552a and 552b) and an outer sheath branch open slit second surface <NUM> (shown here as outer sheath branch open slit second surfaces 554a and 554b). The outer sheath branch open slit first surface 552a, 552b may oppositely face and circumferentially abut the outer sheath branch open slit second surface 554a, 554b. The outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b may be selectively elastically separable. That is, a force may be applied to separate the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b, as that the outer sheath branch open slit first surface 552a, 552b will no longer be abutting the outer sheath branch open slit second surface 554a, 554b. However, upon the removal of the separating force, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b will return to their original abutting position due to the elastic nature of the material forming the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b. Alternatively, instead of abutting, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b may laterally overlap to provide a labyrinth-type seal (not shown). <FIG> depict cross-sectional views of various points along the outer sheath <NUM> having the at least two outer sheath branches 546a, 546b with the outer sheath branch open slits 548a, 548b, to show the structural features of the outer sheath <NUM> having the at least two outer sheath branches 546a, 546b with the outer sheath branch open slits 548a, 548b, as depicted in <FIG>.

As shown in <FIG>, instead of abutting and/or overlapping, at least a portion of the outer sheath branch open slit first surface 552a, 552b may be radially spaced from at least a portion of the outer sheath branch open slit second surface 554a, 554b. The term "radial" is used herein to indicate a direction substantially perpendicular to the "longitudinal" direction, and is shown via arrows "R" in <FIG> extending toward a longitudinal axis LA, in the orientation of <FIG>. When the outer sheath branch open slit 548a, 548b has radially spaced outer sheath branch open slit first and second surfaces 552a, 552b, 554a, 554b, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b may be selectively elastically separable. That is, a force may be applied to separate at least a portion of the outer sheath branch open slit first surface 552a, 552b even further apart from at least a portion of the outer sheath branch open slit second surface 554a, 554b, as that the radial spacing between at least a portion of the outer sheath branch open slit first and second surfaces 552a, 552b, 554a, 554b is larger post-separating forcing than what the radial spacing was pre-separating force. However, upon the removal of the separating force, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b will return to their pre-separating force radial spacing due to the elastic nature of the material forming the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b.

As shown in <FIG>, each of the outer sheath branch open slits 548a, 548b may inwardly taper between a respective outer sheath branch proximal end 550a, 550b and a respective outer open tip 540a, 540b of a respective outer sheath branch 546a, 546b. In other words, the outer sheath branch open slit first surface 552a, 552b may be spaced further apart from the outer sheath branch open slit second surface 554a, 554b at the outer sheath branch proximal end 550a, 550b than at the outer sheath open tip 540a, 540b of a respective outer sheath branch 546a, 546b. The term "taper" is defined herein as a gradual diminution of thickness, diameter, or width in an elongated object, as is shown by the gradual diminution in spacing between outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b at the outer sheath branch proximal end 550a, 550b and the outer sheath branch open slit first and second surfaces 552a, 552b, 554a, 554b at the outer sheath open tip 540a, 540b in <FIG>. The term "inward" is defined herein as a taper that becomes gradually smaller, such as shown as the gradual diminution in spacing between outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b at the outer sheath branch proximal end 550a, 550b and the outer sheath branch open slit first and second surfaces 552a, 552b, 554a, 554b at the outer sheath open tip 540a, 540b in <FIG>. Further, the inward taper, such as the taper of the outer sheath open slit 548a, 548b of <FIG>, could include no expansion in spacing (or even an outward taper) from a respective outer sheath branch proximal end 550a, 550b to a respective outer sheath branch open tip 540a, 540b.

When each of the outer sheath branch open slits 548a, 548b inwardly taper between a respective outer sheath branch proximal end 550a, 550b and a respective outer open tip 540a, 540b of a respective outer sheath branch 546a, 546b, at least a portion of the outer sheath branch open slit first surface 552a, 552b may be radially spaced from at least a portion of the outer sheath branch open slit second surface 554a, 554b, and at least a portion of the outer sheath branch open slit first surface 552a, 552b may circumferentially abut at least a portion of the outer sheath branch open slit second surface 554a, 554b. For example, the outer sheath branch open slit first surface 552a, 552b may be radially spaced further apart from the outer sheath branch open slit second surface 554a, 554b at, and/or adjacent to, the outer sheath branch proximal end 550a, 550b than at, and/or adjacent to, the outer sheath open tip 540a, 540b of a respective outer sheath branch 546a, 546b, and the outer sheath branch open slit first surface 552a, 552b may circumferentially abut the outer sheath branch open slit second surface 554a, 554b at, and/or adjacent to, the outer sheath open tip 540a, 540b of a respective outer sheath branch 546a, 546b.

The outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b of each of the tapered outer sheath branch open slits 548a, 548b may be selectively elastically separable. That is, a force may be applied to separate at least a portion of the outer sheath branch open slit first surface 552a, 552b even further apart from at least a portion of the outer sheath branch open slit second surface 554a, 554b at the radially-spaced portion of the outer sheath branch open slits 548a, 548b, as that the radial spacing between at least a portion of the outer sheath branch open slit first and second surfaces 552a, 552b, 554a, 554b is larger post-separating forcing than what the radial spacing was pre-separating force at the radially-spaced portion of the outer sheath branch open slits 548a, 548b. Additionally, the separating force may be applied to separate the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b at the abutting portion of the outer sheath branch open slits 548a, 548b, as that the outer sheath branch open slit first surface 552a, 552b will no longer be abutting the outer sheath branch open slit second surface 554a, 554b at the abutting portion of the outer sheath branch open slits 548a, 548b.

However, upon the removal of the separating force, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b at the radially-spaced portion of the outer sheath branch open slit 548a, 548b will return to their pre-separating force radial spacing due to the elastic nature of the material forming the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b. Additionally, upon the removal of the separating force, the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b at the abutting portion of the outer sheath branch open slit 548a, 548b will return to their original abutting position due to the elastic nature of the material forming the outer sheath branch open slit first surface 552a, 552b and the outer sheath branch open slit second surface 554a, 554b.

Returning back to <FIG>, at least one c-clip <NUM> (shown here as c-clips 556a and 556b) or other circumferentially extending reinforcing structure may be embedded in the outer sheath <NUM> laterally between the outer sheath outer surface <NUM> and the outer sheath lumen <NUM> and laterally adjacent to a respective outer sheath branch open slit 548a, 548b. For example, a first c-clip 556a may be embedded in a first outer sheath branch 546a adjacent to a first outer sheath branch open slit 548a, and a second c-clip 556b may be embedded in a second outer sheath branch 546b adjacent to a second outer sheath branch open slit 548b. Instead of, or in addition to, the at least one c-clip 556a, 556b being embedded in the outer sheath <NUM>, the at least one c-clip 556a, 556b may be selectively disposed on a portion of the outer sheath outer surface <NUM> that is adjacent to a respective outer sheath open slit <NUM>. For example, a first c-clip 556a may be disposed on the outer sheath outer surface <NUM> on a first outer sheath branch 546a adjacent to a first outer sheath branch open slit 548a, and a second c-clip 556b may be disposed on the outer sheath outer surface <NUM> on a second outer sheath branch 546b adjacent to a second outer sheath branch open slit 548b. Alternatively, or in addition to the above, the at least one c-clip 556a, 556b may be selectively disposed within (e.g., via overmolding) at least a portion of the outer sheath lumen <NUM> that is adjacent to a respective outer sheath open slit 548a, 548b. For example, a first c-clip 556a may be disposed within at least a portion of the outer sheath lumen <NUM> on a first outer sheath branch 546a adjacent to a first outer sheath branch open slit 548a, and a second c-clip 556b may be disposed within at least a portion of the outer sheath lumen <NUM> on a second outer sheath branch 546b adjacent to a second outer sheath branch open slit 548b.

The c-clip 556a, 556b at least partially selectively prevents the outer sheath branch open slit first surface 552a, 552b from elastically separating from the outer sheath branch open slit second surface 554a, 554b when a bifurcated expandable implant branch MB-a, MB-b is disposed within the outer sheath lumen <NUM> adjacent to a respective outer sheath branch open slit 548a, 548b. In other words, an expandable implant M placed within the outer sheath lumen <NUM> in a collapsed condition may tend to want to move toward an expanded condition due to the natural properties of the expandable implant M. For example, the natural properties of the expandable implant M may include shape memory material causing the expandable implant to move from a collapsed condition to an expanded condition, an elastic deformation from a collapsed condition and a biasing back to an expanded condition, and/or any other suitable property of the expandable implant M that may urge a collapsed expandable implant M to move toward an expanded condition. Because the outer sheath open slit first surface 552a, 552b is elastically separable from the outer sheath open slit second surface 554a, 554b, the movement of the expandable implant M toward the expanded condition might tend to cause the outer sheath open slit first surface 552a, 552b to elastically separate from the outer sheath open slit second surface 554a, 554b in an unwanted manner.

However, when the at least one c-clip 556a, 556b is embedded in the outer sheath <NUM>, the at least one c-clip 556a, 556b provides a radially inward pressure or bias to at least partially selectively prevent the expandable implant M from moving from a collapsed condition toward an expanded condition, and thus at least partially prevent the expandable implant M from elastically separating the outer sheath open slit first surface 552a, 552b from the outer sheath open slit second surface 554a, 554b. The at least one c-clip 556a, 556b may be at least partially radiopaque, and thus visible under radiography or other intraoperative imaging techniques to assist with imaging-guided placement and/or orientation.

As shown in <FIG>, the outer sheath distal end might not include any outer sheath branches <NUM>, for some use environments. In such case, the outer sheath <NUM> would have one outer sheath open tip 540a.

The implant delivery system <NUM> may include an inner sheath <NUM> having one of any number of alternate configurations, some of which will be discussed below. As shown in <FIG>, the inner sheath <NUM> has an inner sheath proximal end <NUM>, an inner sheath distal end <NUM>, and an inner sheath body <NUM> longitudinally extending between the inner sheath proximal and distal ends <NUM>, <NUM>. The inner sheath proximal end <NUM> may have an inner sheath proximal opening <NUM>. The inner sheath distal end <NUM> may have an inner sheath open tip <NUM>. The inner sheath <NUM> may have an inner sheath outer surface <NUM> and an inner sheath lumen <NUM>. The inner sheath lumen <NUM> may longitudinally extend between the inner sheath proximal opening <NUM> and the inner sheath open tip <NUM>. The inner sheath lumen <NUM> is at least partially configured for selectively preventing at least a portion of the bifurcated expandable implant M from expanding from a collapsed condition when at least a portion of the bifurcated expandable implant M is disposed within the inner sheath lumen <NUM>.

As shown in <FIG>, the inner sheath distal end <NUM> and the inner sheath body <NUM> may be substantially level. The term "level" is defined herein as being substantially even or unvarying in diameter, as is shown by the inner sheath distal end <NUM> not having a gradual or stepwise diminution and/or increase in diameter in <FIG>. As shown in <FIG>, at least a portion of the inner sheath distal end <NUM> may inwardly taper at least partially from the inner sheath open tip <NUM> toward the longitudinally proximal direction.

As shown in <FIG>, the inner sheath <NUM> may have at least one set of open slit cover members <NUM> (shown here as open slit cover members 1274a, 1274b, 1274c, and 1274d). The inner sheath <NUM> may have a first set of open slit cover members <NUM> and a second set of open slit cover members <NUM> (<FIG>). The term "set" is defined herein as a number of things of the same kind that are used together. For example, the open slit cover members 1274a, 1274b of the first set of open slit cover members <NUM> are used together, and the open slit cover members 1274c, 1274d of the second set of open slit cover members <NUM> are used together, as will be described below. Each of the open slit cover members 1274a, 1274b, 1274c, 1274d may longitudinally extend from the inner sheath distal end <NUM> in a longitudinally distal direction (as shown as an arrow "X" in <FIG>). Each open slit cover member 1274a, 1274b, 1274c, 1274d of a respective set of open slit of cover members <NUM>, <NUM> may be oppositely positioned on the inner sheath distal end <NUM> from a respective open slit cover member 1274a, 1274b, 1274c, 1274d of the respective set of open slit cover members <NUM>, <NUM>. When the inner sheath <NUM> has the first and second sets of open slit cover members <NUM>, <NUM>, the first set of open slit cover members <NUM> may be oppositely positioned on the inner sheath distal end <NUM> from the second set of open slit cover member <NUM>.

As shown in <FIG>, each open slit cover member 1274a, 1274b, 1274c, 1274d of the first and second sets of open slit cover members <NUM>, <NUM> may be substantially longitudinally level. As shown in <FIG>, each open slit cover member 1274a, 1274b, 1274c, 1274d of a respective set of open slit cover members <NUM>, <NUM> may overlap to form an overlapping portion <NUM> (shown here as overlapping portions 1380a and 1380b) of each of the open slit cover members 1274a, 1274b, 1274c, 1274d of the respective set of open slit cover members <NUM>, <NUM>. In other words, a first open slit cover member 1274a of a first set of open slit cover members <NUM> may overlap a second open slit cover member 1274b of the first set of open slit cover members <NUM> to form an overlapping portion 1380a, and a first open slit cover member 1274c of a second set of open slit cover members <NUM> may overlap a second open slit cover member 1274d of the second set of open slit cover members <NUM> to form an overlapping portion 1380b. The term "overlap" is defined herein as to place or be placed so that at least a part of one covers at least a corresponding part of another as is shown by at least one of the open slit cover members 1274a, 1274b, 1274c, 1274d overlapping another of the open slit cover members 1274a, 1274b, 1274c, 1274d in <FIG>. As shown in <FIG>, each open slit cover member 1274a, 1274b of a respective set of open slit cover members <NUM>, <NUM> may be helical. The term "helix" is defined herein as the shape formed by a line that curves around and along a central line, such as a central open slit cover member axis CA, as shown in <FIG>.

As depicted in <FIG>, when the inner sheath <NUM> is operatively joined to the outer sheath <NUM>, at least a portion of each open slit cover member 1274a, 1274b, 1274c, 1274d, when provided, is positioned within the outer sheath lumen <NUM> adjacent to a respective outer sheath branch open slit 548a, 548b and at least partially selectively covers the respective outer sheath branch open slit 548a, 548b, as will be described below. <FIG> depicts at least a portion of the open slit cover members 1274a, 1274b, 1274c, 1274d of a respective set of open slit cover members <NUM>, <NUM> (such as the first set of open slit cover members <NUM>, as depicted in <FIG>) being selectively positioned within the outer sheath lumen <NUM> adjacent to a respective outer sheath branch open slit 548a, 548b and at least the overlapping portion 1380a, 1380b of the open slit cover members 1274a, 1274b, 1274c, 1274d at least partially selectively covering the respective outer sheath branch open slit 548a, 548b. <FIG> depicts at least a portion of a helical open slit cover member 1274a, 1274b, 1274c, 1274d of a respective set of open slit cover members <NUM>, <NUM> (such as the first set of open slit cover members <NUM>, as depicted in <FIG>) being selectively positioned within the outer sheath lumen <NUM> adjacent to a respective outer sheath branch open slit 548a, 548b and at least a portion of the helical open slit cover member 1274a, 1274b, 1274c, 1274d at least partially selectively covering the respective outer sheath branch open slit 548a, 548b.

As shown in <FIG>, the implant delivery system <NUM> including any configuration of the outer sheath <NUM> may be operatively joined to any configuration of the shaft <NUM>, and any configuration of the inner sheath <NUM>, when provided. For the sake of brevity, not every possible combination of the alternate configurations of the outer sheath <NUM>, the alternate configurations of the shaft <NUM>, and the alternate configurations of the inner sheath <NUM>, when provided, are specifically discussed and/or depicted herein, but one of ordinary skill in the art will be able to provide a suitable configuration for a particular use environment, whether or not specifically discussed and/or depicted herein, according to the teachings of the present invention.

<FIG> depicts the outer sheath <NUM> having the at least two outer sheath branches 546a, 546b operably joined both to the shaft <NUM> having the at least two shaft branches 112a, 112b with the nosecones 118a, 118b, and to the inner sheath <NUM> having a substantially level inner sheath distal end <NUM> and inner sheath body <NUM>. When the bifurcated implant delivery system <NUM> is in the configuration shown in <FIG>, at least a portion of the shaft <NUM> and at least a portion of the inner sheath <NUM> may be positioned within the outer sheath lumen <NUM>. For example, at least a portion of the shaft body <NUM> and the inner sheath <NUM> may be positioned radially adjacent to at least a portion of the outer sheath body <NUM> within the outer sheath lumen <NUM>, and at least a portion of each of the shaft branches 112a, 112b may be positioned radially adjacent to a respective outer sheath branch 546a, 546b within the outer sheath lumen <NUM>. Each of the nosecones 118a, 118b may be longitudinally adjacent to a respective outer sheath open tip 540a, 540b.

The shaft outer surface <NUM> may have a bifurcated expandable implant M disposed, alternatively referred to as "mounted," thereon, wherein at least one of the outer sheath lumen <NUM> and the inner sheath lumen <NUM> at least partially restricts/inhibits/prevents the expandable implant M from moving from a collapsed condition toward an expanded condition. For example, at least a portion of a collapsed expandable implant body MO of a collapsed expandable implant M may be disposed on at least a portion of the shaft body <NUM> and restricted/inhibited/prevented from moving toward the expanded condition by a radially adjacent inner sheath lumen <NUM>. At least a portion of each collapsed expandable implant branches MB-a, MB-b of the collapsed expandable implant M may be disposed on at least a portion of a respective shaft branch 112a, 112b and restricted/inhibited/prevented from moving toward the expanded condition by a radially adjacent outer sheath lumen <NUM> of a respective outer sheath branch 546a, 546b. In other words, a collapsed bifurcated expandable implant M placed within at least one of the outer sheath lumen <NUM> and the inner sheath lumen <NUM> may tend to want to move toward an expanded condition due to the natural properties of the expandable implant M. However, as shown in <FIG>, at least one of the outer sheath lumen <NUM> and the inner sheath lumen <NUM> provides a radially inward force to at least partially restrict/inhibit/prevent the collapsed bifurcated expandable implant M from fully expanding, and/or moving toward an expanded condition. Additionally, when the shaft outer surface <NUM> has the bifurcated expandable implant M disposed thereon, at least a portion of the expandable implant transition portion MT may at least partially contact a reinforcing element distal end <NUM>.

<FIG> depicts the outer sheath <NUM> having one outer sheath open tip <NUM> operably joined both to the shaft <NUM> having the at least two shaft branches 112a, 112b with the nosecones 118a, 118b and the elastic skirts 222a, 222b, and to the inner sheath <NUM> having a substantially level inner sheath distal end <NUM> and inner sheath body <NUM>. When the bifurcated implant delivery system <NUM> is in the configuration shown in <FIG>, at least a portion of the shaft <NUM> and at least a portion of the inner sheath <NUM> may be positioned within the outer sheath lumen <NUM>. For example, at least a portion of the shaft body <NUM>, at least a portion of each of the shaft branches 112a, 112b, and at least a portion of the inner sheath <NUM> may be positioned radially adjacent to at least a portion of the outer sheath body <NUM> within the outer sheath lumen <NUM>, and at least a portion of each of the shaft branches 112a, 112b may extend, in the longitudinally distal direction, outward from the outer sheath open tip <NUM>. At least one of the nosecones 118a, 118b and the elastic skirts 222a, 222b may be longitudinally adjacent to the outer sheath open tip <NUM>.

The shaft outer surface <NUM> may have a bifurcated expandable implant M disposed, alternatively referred to mounted, thereon, wherein at least one of the outer sheath lumen <NUM>, the elastic skirts 222a, 222b, and the inner sheath lumen <NUM> at least partially restricts/inhibits/prevents the expandable implant M from moving from a collapsed condition toward an expanded condition. For example, at least a portion of a collapsed expandable implant body MO of a collapsed expandable implant M may be disposed on at least a portion of the shaft body <NUM> and restricted/inhibited/prevented from moving toward the expanded condition by a radially adjacent inner sheath lumen <NUM>. At least a portion of each collapsed expandable implant branches MB-a, MB-b of the collapsed expandable implant M may be disposed on at least a portion of a respective shaft branch 112a, 112b and restricted/inhibited/prevented from moving toward the expanded condition by at least a portion of a radially adjacent outer sheath lumen <NUM> and at least a portion of a respective radially adjacent elastic skirt 222a, 222b. In other words, a collapsed bifurcated expandable implant M placed within at least one of the outer sheath lumen <NUM>, the inner sheath lumen <NUM>, and the elastic skirts 222a, 222b may tend to want to move toward an expanded condition due to the natural properties of the expandable implant M. However, as shown in <FIG>, at least one of the outer sheath lumen <NUM>, the inner sheath lumen <NUM>, and the elastic skirts 222a, 222b provides a radially inward force to at least partially restrict/inhibit/prevent the collapsed bifurcated expandable implant M from fully expanding, and/or moving toward an expanded condition. Additionally, when the shaft outer surface <NUM> has the bifurcated expandable implant M disposed thereon, at least a portion of a reinforcing element distal end <NUM> may be longitudinally spaced from the expandable implant transition portion MT, and may be configured to be at least partially brought into contact with at least a portion of the expandable implant transition portion MT, as will be described below.

<FIG> depicts the outer sheath <NUM> having one outer sheath open tip <NUM> operably joined to the shaft <NUM> having the at least two shaft branches 112a, 112b with the nosecones 118a, 118b and the elastic skirts 222a, 222b. When the bifurcated implant delivery system <NUM> is in the configuration shown in <FIG>, at least a portion of the shaft <NUM> may be positioned within the outer sheath lumen <NUM>. For example, at least a portion of the shaft body <NUM> and at least a portion of each of the shaft branches 112a, 112b may be positioned radially adjacent to at least a portion of the outer sheath body <NUM> within the outer sheath lumen <NUM>, and at least a portion of each of the shaft branches 112a, 112b may extend, in the longitudinally distal direction, outward from the outer sheath open tip <NUM>. At least one of the nosecones 118a, 118b and the elastic skirts 222a, 222b may be longitudinally adjacent to the outer sheath open tip <NUM>.

The shaft outer surface <NUM> may have a bifurcated expandable implant M disposed, alternatively referred to mounted, thereon, wherein at least one of the outer sheath lumen <NUM> and the elastic skirts 222a, 222b at least partially restricts/inhibits/prevents the expandable implant M from moving from a collapsed condition toward an expanded condition. For example, at least a portion of a collapsed expandable implant body MO of a collapsed expandable implant M may be disposed on at least a portion of the shaft body <NUM> and restricted/inhibited/prevented from moving toward the expanded condition by a radially adjacent outer sheath lumen <NUM>. At least a portion of each collapsed expandable implant branches MB-a, MB-b of the collapsed expandable implant M may be disposed on at least a portion of a respective shaft branch 112a, 112b and restricted/inhibited/prevented from moving toward the expanded condition by at least a portion of a radially adjacent outer sheath lumen <NUM> and at least a portion of a respective radially adjacent elastic skirt 222a, 222b. In other words, a collapsed bifurcated expandable implant M placed within at least one of the outer sheath lumen <NUM> and the elastic skirts 222a, 222b may tend to want to move toward an expanded condition due to the natural properties of the expandable implant M. However, as shown in <FIG>, at least one of the outer sheath lumen <NUM> and the elastic skirts 222a, 222b provides a radially inward force to at least partially restrict/inhibit/prevent the collapsed bifurcated expandable implant M from fully expanding, and/or moving toward an expanded condition. Additionally, when the shaft outer surface <NUM> has the bifurcated expandable implant M disposed thereon, at least a portion of a reinforcing element distal end <NUM> may be longitudinally spaced from the expandable implant transition portion MT, and may be configured to be at least partially brought into contact with at least a portion of the expandable implant transition portion MT, as will be described below.

In use, the bifurcated implant delivery system <NUM>, as described above, is provided to the user. The implant delivery system <NUM> may include any configuration of the outer sheath <NUM>, any configuration of the shaft <NUM>, and any configuration of the inner sheath <NUM> when provided, or a combination of individual features described above for the alternate configurations of the outer sheath <NUM>, the shaft <NUM>, and the inner sheath <NUM>. For the sake of brevity, not every possible combination of the alternate configurations of the outer sheath <NUM>, the alternate configurations of the shaft <NUM>, and the alternate configurations of the inner sheath <NUM>, when provided, are discussed and/or depicted. However, it is to be understood that the following description may be applicable to any combination of configurations of the outer sheath <NUM>, the shaft <NUM>, and the inner sheath <NUM>, when provided, that one of ordinary skill in the art could devise, based upon the present teachings.

<FIG> depict an example sequence of operation of the bifurcated implant delivery system <NUM>, as depicted in <FIG>. At least one bifurcated expandable implant M, which can be self-expandable and/or expand through external means (e.g., a balloon), is provided. The bifurcated expandable implant M may have an expandable implant body MO, at least two expandable implant branches MB-a, MB-b, and an expandable implant transition portion MT longitudinally between the expandable implant body MO and the at least two expandable implant branches MB-a, MB-b.

As shown in <FIG>, a collapsed expandable implant M may be placed in operative engagement with the shaft outer surface <NUM>. In particular, a collapsed bifurcated expandable implant M may be circumferentially mounted on the shaft outer surface <NUM> with the expandable implant body MO circumferentially mounted on at least a portion of the shaft body <NUM>, each of the expandable implant branches MB-a, MB-b circumferentially mounted on a respective shaft branch 112a, 112b, and at least a portion of the expandable implant transition portion MT at least partially contacting a reinforcing element distal end <NUM>.

As shown in <FIG>, with the collapsed bifurcated expandable implant mounted M on the shaft <NUM>, at least a portion of the collapsed expandable implant body MO and at least a portion of the shaft body <NUM> may be operatively engaged to the inner sheath <NUM>, such as by being collectively inserted into at least a portion of the inner sheath lumen <NUM>. As shown in <FIG>, when the inner sheath <NUM> has at least one set of open slit cover members <NUM>, <NUM>, the open slit cover members 1274a, 1274b, 1274c, 1274d may at least partially surround and/or engage at least a portion of the collapsed expandable implant M when the shaft <NUM> and at least a portion of the collapsed expandable implant M is operatively engaged to the inner sheath <NUM>.

As shown in <FIG>, at least a portion of the inner sheath <NUM>, at least a portion of the collapsed bifurcated expandable implant M and at least a portion of the shaft <NUM> may be operatively joined to the outer sheath <NUM>, such as by being collectively inserted into at least a portion of the outer sheath lumen <NUM>. With at least a portion of the collapsed bifurcated expandable implant M, at least a portion of the shaft <NUM>, and at least a portion of the inner sheath <NUM> inserted in the outer sheath lumen <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the collapsed bifurcated expandable implant M may be positioned in the outer sheath lumen <NUM>. In particular, the inner sheath <NUM>, the shaft <NUM>, and the collapsed bifurcated expandable implant M may be positioned in the outer sheath lumen <NUM> with at least a portion of the inner sheath <NUM>, at least a portion of the shaft body <NUM>, and at least a portion of the expandable implant body MO being in, and/or radially adjacent to, the outer sheath body <NUM>, with at least a portion of each shaft branch 112a, 112b and at least a portion of each collapsed expandable implant branch MB-a, MB-b being in, and/or radially adjacent to, a respective outer sheath branch 546a, 546b, and with each nosecone 118a, 118b being longitudinally adjacent to a respective outer sheath open tip 540a, 540b.

As shown in <FIG>, when the inner sheath <NUM> has at least one set of open slit cover members <NUM>, <NUM>, the inner sheath <NUM> may be aligned/positioned in the outer sheath lumen <NUM> with at least a portion of each open slit cover member 1274a, 1274b, 1274c, 1274d being positioned adjacent to a respective outer sheath branch open slit 548a, 548b, and at least partially covering the respective outer sheath branch open slit 548a, 548b. Each open slit cover member 1274a, 1274b, 1274c, 1274d may at least partially provide a barrier between a respective outer sheath branch open slit 548a, 548b and a respective expandable implant branch MB-a, MB-b. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM> with the open slit cover members 1274a, 1274b, 1274c, 1274d, and the bifurcated expandable implant M in <FIG>. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM> with the open slit cover members 1274a, 1274b, 1274c, 1274d, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, at least two guidewire distal ends <NUM> (shown here as guidewire distal ends 2888a and 2888b) are inserted into a target patient tissue site T in a patient lumen L with each guidewire distal end 2888a, 2888b of at least two guidewires <NUM> (shown here as guidewires 2890a and 2890b) being positioned in a respective patient lumen branch LB-a, LB-b. Each patient lumen branch LB-a, LB-b bifurcates from a patient lumen main portion LP. Each guidewire proximal end <NUM> (shown here as guidewire proximal ends 2892a and 2892b) of the at least two guidewires 2890a, 2890b are directed through the implant delivery system <NUM> by being directed through the at least one shaft lumen <NUM>, such as through a respective shaft lumen 126a, 126b. As shown in <FIG>, the implant delivery system <NUM> may be directed to the target patient tissue site T along the at least two guidewires 2890a, 2890b.

The implant delivery system <NUM> may be positioned at the target patient tissue site T. In particular, at least a portion of the outer sheath <NUM>, at least a portion of the inner sheath <NUM>, at least a portion of the shaft body <NUM>, and at least a portion of the expandable implant body MO may be positioned in a patient lumen main portion LP. At least a portion of each outer sheath branch 546a, 546b, at least a portion of each shaft branch 112a, 112b, and at least a portion of each expandable implant branch MB-a, MB-b may be positioned in a respective patient lumen branch LB-a, LB-b. At least a portion of the reinforcing element distal end <NUM> and at least a portion of the expandable implant transition portion MT may be positioned at a patient lumen transition portion LT. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, with the implant delivery system <NUM> positioned at the target patient tissue site T, at least a portion of the bifurcated expandable implant M may be exposed by urging the outer sheath <NUM> in the longitudinally proximal direction (shown as an arrow "Y" in <FIG>). In particular, the expandable implant branches MB-a, MB-b may be exposed by urging the outer sheath <NUM> in the longitudinally proximal direction. Movement of the outer sheath <NUM> in the longitudinally proximal direction may cause at least one of the expandable implant branches MB-a, MB-b, the shaft branches 112a, 112b, and the open slit cover members 1274a, 1274b, 1274c, 1274d, when provided, to move along a respective outer sheath open slit 548a, 548b to selectively elastically separate a respective outer sheath open slit first surface 552a, 552b from a respective outer sheath open slit second surface 554a, 554b and accordingly permit the outer sheath <NUM> to be directed in the longitudinally proximal direction. The elastic separation caused by at least one of the expandable implant branches MB-a, MB-b, the shaft branches 112a, 112b, and the open slit cover members 1274a, 1274b, 1274c, 1274d, when provided, moving along a respective outer sheath open slit 548a, 548b can be thought of as an "unzipping"-type process.

While the outer sheath is urged in the longitudinally proximal direction, at least a portion of the implant delivery system <NUM> and the bifurcated expandable implant M may be maintained in position at the target patient tissue site T. In particular, the at least two guidewires 2890a, 2890b, the inner sheath <NUM>, the expandable implant body MO, and the shaft body <NUM> may be maintained at the patient lumen main portion LP. Each of the guidewire distal ends 2888a, 2888b, the expandable implant branches MB-a, MB-b, and the shaft branches 112a, 112b may be maintained at the respective patient lumen branches LB-a, LB-b. The reinforcing element distal end <NUM> and the expandable implant transition portion MT may be maintained at the patient lumen transition portion LT. The contact between the expandable implant transition portion MT and the reinforcing element distal end <NUM> may at least partially maintain the expandable implant transition portion MT at the patient lumen transition portion LT while the outer sheath <NUM> is urged in the proximal direction by providing a force in the longitudinally distal direction (shown as an arrow "X" in <FIG>) against at least a portion of the expandable implant transition portion MT. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, with at least a portion of the bifurcated expandable implant M exposed (such as the expandable implant branches Mb-a, MB-b, as depicted in <FIG>), the properties of the bifurcated expandable implant M may be utilized to move the exposed portion of the bifurcated expandable implant M toward the expanded condition. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, with the expandable implant branches MB-a, MB-b exposed, the bifurcated expandable implant body MO may be exposed by urging the inner sheath <NUM> in the longitudinally proximal direction. While the inner sheath <NUM> is urged in the longitudinally proximal direction, at least a portion of the implant delivery system <NUM> and the bifurcated expandable implant M may be maintained in position at the target patient tissue site T. In particular, the at least two guidewires 2890a, 2890b, the expandable implant body MO, and the shaft body <NUM> may be maintained at the patient lumen main portion LP. The guidewire distal ends 2888a, 2888b, the expandable implant branches MB-a, MB-b, and the shaft branches 112a, 112b may be maintained at the respective patient lumen branches LB-a, LB-b. The reinforcing element distal end <NUM> and the expandable implant transition portion MT may be maintained at the patient lumen transition portion LT. The contact between the expandable implant transition portion MT and the reinforcing element distal end <NUM> at least partially maintains the expandable implant transition portion MT at the patient lumen transition portion LT while the inner sheath <NUM> is urged in the proximal direction by providing a force in the longitudinally distal direction (shown as an arrow "X" in <FIG>) against at least a portion of the expandable implant transition portion MT.

As shown in <FIG>, with at least a portion of the bifurcated expandable implant M exposed (such as the expandable implant branches Mb-a, MB-b and the expandable implant body MO), the properties of the bifurcated expandable implant M may be utilized to move the exposed portion of the bifurcated expandable implant M toward the expanded condition. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>. As depicted in <FIG>, with the bifurcated expandable implant M in the expanded condition, the outer sheath <NUM>, the shaft <NUM>, the inner sheath <NUM>, and/or the at least one guidewire 2890a, 2890b, may be removed from at least one of the target patient tissue site T, the patient lumen main portion LP, and at least one of the patient lumen branches LB-a, LB-b. <FIG> depict cross-sectional views of various points along the expanded bifurcated expandable implant M in <FIG>.

Alternatively, after the outer sheath <NUM>, the shaft <NUM>, and the inner sheath <NUM> have been removed, a secondary device may be directed over at least one of the guidewires 2890a, 2890b to perform a medical procedure with the secondary device at the target patient tissue site T, the patient lumen main portion LP, and/or at the one of the patient lumen branches LB-a, LB-b. As shown in <FIG>, the secondary device may be a balloon dilation device <NUM> having at least two balloon dilation device branches <NUM> (shown here as balloon dilation device branches 3496a and 3496b), a bifurcated expandable balloon <NUM>, and a balloon inflation channel <NUM> for directing inflation fluid to the bifurcated expandable balloon <NUM>. As shown in <FIG>, the balloon dilation device <NUM> may have a single balloon dilation device lumen <NUM> that longitudinally extends between a balloon dilation device proximal opening <NUM> and each balloon dilation device open tip <NUM> (shown here as balloon dilation device open tips 34106a and 34106b) of the balloon dilation device branches 3496a, 3496b. <FIG> depict cross-sectional views of various points along the balloon dilation device <NUM>, to show the structural features of the balloon dilation device <NUM>, as depicted in <FIG>. As shown in <FIG>, the balloon dilation device <NUM> may have at least two balloon dilation device lumens <NUM> (shown here as balloon dilation device lumens 34102a and 34102b) that longitudinally extend between respective balloon dilation device proximal openings <NUM> (shown here as balloon dilation device proximal openings 34104a and 34104b) and respective balloon dilation device open tips 34106a, 34106b. <FIG> depict cross-sectional views of various points along the balloon dilation device <NUM>, to show the structural features of the balloon dilation device <NUM>, as depicted in <FIG>.

As shown in <FIG>, the balloon dilation device <NUM> may be directed along the at least two guidewires 2890a, 2890b and positioned with at least a portion of the bifurcated expandable balloon <NUM> within a diseased segment of the patient lumen L and/or adjacent to an inner surface of the bifurcated expandable implant M. The bifurcated expandable balloon <NUM> may be inflated to dilate the diseased segment of the patient lumen L and/or cause the expandable implant M to further expand. With the expandable implant M further expanded, the expandable balloon <NUM> may be deflated. At least one of the balloon dilation device <NUM> and the at least two guidewires 2890a, 2890b may then be removed from the target patient tissue site T, the patient lumen main portion LP, and/or at least one of the patient lumen branches LB-a, LB-b by moving at least one of the balloon dilation device <NUM> and at least one of the guidewires 2890a, 2890b in the longitudinally proximal direction.

Although the above description of the example sequence of operation for the implant delivery system <NUM> of <FIG>, one of ordinary skill in the art will understand, given the teachings of the present application, how to operate any configuration for the shaft <NUM>, the inner sheath <NUM>, when provided, and the outer sheath <NUM> similarly. For example, <FIG> depict an example sequence of operation of the bifurcated implant delivery system <NUM>, as depicted in <FIG>. The at least one bifurcated expandable implant M, which can be self-expandable and/or expand through external means (e.g., a balloon), is provided.

As shown in <FIG>, a collapsed expandable implant M may be placed in operative engagement with the shaft outer surface <NUM>. In particular, a collapsed bifurcated expandable implant M may be circumferentially mounted on the shaft outer surface <NUM> with the expandable implant body MO circumferentially mounted on at least a portion of the shaft body <NUM>, each of the expandable implant branches MB-a, MB-b circumferentially mounted on a respective shaft branch 112a, 112b, and at least a portion of the expandable implant transition portion MT being longitudinally spaced from a reinforcing element distal end <NUM>. Each elastic skirt 222a, 222b may be operatively engaged to a respective collapsed expandable implant branch MB-a, MB-b by placing each elastic skirt 222a, 222b on at least a portion of the collapsed respective expandable implant branch MB-a, MB-b.

As shown in <FIG>, with the collapsed bifurcated expandable implant mounted M on the shaft <NUM>, at least a portion of the collapsed expandable implant body MO and at least a portion of the shaft body <NUM> may be operatively engaged to the inner sheath <NUM>, such as by being collectively inserted into at least a portion of the inner sheath lumen <NUM>. As shown in <FIG>, at least a portion of the inner sheath <NUM>, at least a portion of the collapsed bifurcated expandable implant M, and at least a portion of the shaft <NUM> may be operatively joined to the outer sheath <NUM>, such as by being collectively inserted into at least a portion of the outer sheath lumen <NUM>.

As depicted in <FIG>, at least two guidewire distal ends 2888a, 2888b may be inserted into a target patient tissue site T in a patient lumen L with each guidewire distal end 2888a, 2888b of at least two guidewires 2890a, 2890b being positioned in a respective patient lumen branch LB-a, LB-b. Each guidewire proximal end 2892a, 2892b of the at least two guidewires 2890a, 2890b are directed through the implant delivery system <NUM> by being directed through the at least one shaft lumen <NUM>, such as through a respective shaft lumen 126a, 126b. As shown in <FIG>, the implant delivery system <NUM> may be directed to the target patient tissue site T along the at least two guidewires 2890a, 2890b.

As shown in <FIG>, the implant delivery system <NUM> may be positioned at the target patient tissue site T. In particular, at least a portion of the outer sheath <NUM>, at least a portion of the inner sheath <NUM>, at least a portion of the shaft body <NUM>, and at least a portion of the expandable implant body MO may be positioned in a patient lumen main portion LP. At least a portion of each shaft branch 112a, 112b and at least a portion of each expandable implant branch MB-a, MB-b may be positioned in a respective patient lumen branch LB-a, LB-b. At least a portion of the expandable implant transition portion MT may be positioned at a patient lumen transition portion LT. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, with the implant delivery system <NUM> positioned at the target patient tissue site T, at least a portion of the bifurcated expandable implant M may be exposed by urging the shaft <NUM> in the longitudinally distal direction (shown as an arrow "X" in <FIG>). In particular, a first portion of the expandable implant branches MB-a1, MB-b1 may be exposed by urging the shaft <NUM> in the longitudinally distal direction. Movement of the shaft <NUM> in the longitudinally distal direction may cause each of the elastic skirts 222a, 222b to operatively disengage the respective expandable implant branch MB-a, MB-b. With at least a portion of the bifurcated expandable implant M exposed (such as the first portion of the expandable implant branches Mb-a1, MB-b1, as depicted in <FIG>), the properties of the bifurcated expandable implant M may be utilized to move the exposed portion of the bifurcated expandable implant M toward the expanded condition. Further, movement of the shaft <NUM> in the longitudinally distal direction may cause at least a portion of the reinforcing element distal end <NUM> to at least partially contact the expandable implant transition portion MT. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As shown in <FIG>, with the first portion of the expandable implant branches exposed MB-a1, MB-b1, at least one of a second portion of the expandable implant branches MB-a2, MB-b2 and the expandable implant body MO may be exposed by urging the outer sheath in the longitudinally proximal direction (shown as an arrow "Y" in <FIG>. While the outer sheath <NUM> is urged in the longitudinally proximal direction, at least a portion of the implant delivery system <NUM> and the bifurcated expandable implant M may be maintained in position at the target patient tissue site T. In particular, the at least two guidewires 2890a, 2890b, the inner sheath <NUM>, the expandable implant body MO, and the shaft body <NUM> may be maintained at the patient lumen main portion LP. Each of the guidewire distal ends 2888a, 2888b, the expandable implant branches MB-a, MB-b, and the shaft branches 112a, 112b may be maintained at the respective patient lumen branches LB-a, LB-b. The reinforcing element distal end <NUM> and the expandable implant transition portion MT may be maintained at the patient lumen transition portion LT. The contact between the expandable implant transition portion MT and the reinforcing element distal end <NUM> may at least partially maintain the expandable implant transition portion MT at the patient lumen transition portion LT while the outer sheath <NUM> is urged in the proximal direction by providing a force in the longitudinally distal direction (shown as an arrow "X" in <FIG>) against at least a portion of the expandable implant transition portion MT.

If the inner sheath <NUM> is provided in the implant delivery system <NUM>, the inner sheath <NUM> may cause at least a portion of the expandable implant body MO disposed within the inner sheath lumen <NUM> to be restricted/inhibited/prevented from moving toward the expanded condition when the outer sheath <NUM> is urged the longitudinally proximal direction. In such case, as shown in <FIG>, with the outer sheath <NUM> urged in the longitudinally proximal direction, at least a portion of the expandable implant body MO may be exposed by urging the inner sheath <NUM> in the longitudinally proximal direction.

While the inner sheath <NUM> is urged in the longitudinally proximal direction, at least a portion of the implant delivery system <NUM> and the bifurcated expandable implant M may be maintained in position at the target patient tissue site T. In particular, the at least two guidewires 2890a, 2890b, the expandable implant body MO, and the shaft body <NUM> may be maintained at the patient lumen main portion LP. The guidewire distal ends 2888a, 2888b, the expandable implant branches MB-a, MB-b, and the shaft branches 112a, 112b may be maintained at the respective patient lumen branches LB-a, LB-b. The reinforcing element distal end <NUM> and the expandable implant transition portion MT may be maintained at the patient lumen transition portion LT. The contact between the expandable implant transition portion MT and the reinforcing element distal end <NUM> at least partially maintains the expandable implant transition portion MT at the patient lumen transition portion LT while the inner sheath <NUM> is urged in the proximal direction by providing a force in the longitudinally distal direction against at least a portion of the expandable implant transition portion MT.

As shown in <FIG>, with at least a portion of the bifurcated expandable implant M exposed (such as the expandable implant branches Mb-a, MB-b and the expandable implant body MO), the properties of the bifurcated expandable implant M may be utilized to move the exposed portion of the bifurcated expandable implant M toward the expanded condition. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the inner sheath <NUM>, the shaft <NUM>, and the bifurcated expandable implant M in <FIG>.

As depicted in <FIG>, with the bifurcated expandable implant M in the expanded condition, the outer sheath <NUM>, the shaft <NUM>, the inner sheath <NUM>, and/or the at least one guidewire 2890a, 2890b, may be removed from at least one of the target patient tissue site T, the patient lumen main portion LP, and at least one of the patient lumen branches LB-a, LB-b. For example, as shown in <FIG>, at least one of the outer sheath <NUM> and the inner sheath <NUM> may be moved in the longitudinally distal direction, and/or the shaft <NUM> may be moved in the longitudinally proximal direction. As shown in <FIG>, once at least a portion of the elastic skirts 222a, 222b of the shaft <NUM> are adjacent to, in contact with, or disposed within the outer sheath open tip <NUM>, the implant delivery system <NUM> may be moved in the longitudinally proximal direction to remove the implant delivery system <NUM> from the target patient tissue site T, while maintaining the expanded bifurcated expandable implant M at the target patient tissue site T.

As shown in <FIG>, after the implant delivery system <NUM> has been removed, a secondary device (such as the balloon dilation device <NUM>) may be directed over at least one of the guidewires 2890a, 2890b to perform a medical procedure with the secondary device at the target patient tissue site T, the patient lumen main portion LP, and/or at the one of the patient lumen branches LB-a, LB-b, in a similar sequence to that described above.

Although the above descriptions of the example sequence of operation for the implant delivery system <NUM> reference the implant delivery systems <NUM> depicted in <FIG>, one of ordinary skill in the art will understand, given the teachings of the present application, how to similarly operate any configuration for the shaft <NUM>, the outer sheath <NUM>, and the inner sheath, when provided.

Any of the alternate outer sheath <NUM> configurations, the alternate shaft <NUM> configurations, the alternate inner sheath configurations <NUM>, when provided, the at least one c-clip <NUM>, when provided, the reinforcing element <NUM>, when provided, the nosecones 118a, 118b, when provided, the elastic skirts 222a, 222b, when provided, the open slit cover members 1274a, 1274b, 1274c, 1274d, and the balloon dilation device <NUM>, when provided, of the implant delivery system <NUM> may be at least partially formed from silicone, polyethylene, polypropylene, stainless steel, titanium, rubber, latex, polychloroprene, nylon, any other biocompatible material, or any combination thereof.

The bifurcated expandable implant M may be at least partially formed from materials having self-expanding properties, such as, but not limited to, stainless steel and shape memory materials. An example of a shape memory material is, for example, Nitinol. In such case, the bifurcated expandable implant M at least partially formed from materials having self-expanding properties may be moved to the collapsed condition through a direct and/or indirect user interaction, and mounted on the shaft outer surface <NUM>. For example, a bifurcated expandable implant M at least partially formed from a shape memory material may be cooled to a temperature below the transition temperature range, moved to the collapsed condition, and mounted on the shaft outer surface <NUM>. When the bifurcated expandable implant M at least partially formed from a shape memory material is exposed at the target patient tissue site T, the self-expanding properties of the bifurcated expandable implant M may at least partially cause the bifurcated expandable implant M to move from the collapsed condition toward the expanded condition. Further, the temperature of the environment at the target patient tissue site T at least partially causes the bifurcated expandable implant M at least partially formed from a shape memory material to move from the collapsed condition toward the expanded condition.

It is contemplated that a bifurcated expandable implant M at least partially formed from a shape memory material may be more easily conformable to the shape of the target patient tissue site T than what a bifurcated expandable implant M not made at least partially from a shape memory material would be. However, a bifurcated expandable implant M that has self-expanding properties, but is not at least partially made from a shape memory material, may not have to be cooled in order to be moved toward the collapsed condition, and/or may not require the temperature of the of the environment at the target patient tissue site T in order to move from the collapsed condition toward the expanded condition.

It is contemplated that at least one of the alternate outer sheath <NUM> configurations, the alternate shaft <NUM> configurations, the alternate inner sheath <NUM> configurations, when provided, and the balloon dilation device <NUM>, when provided of the implant delivery system <NUM> may be disposed within one or more conventional sheaths (not shown) to deliver at least a portion of the implant delivery system <NUM> to the target patient tissue site T through a patient tissue access point.

Further, the implant delivery system <NUM> provides the user with the ability to deploy at least one bifurcated expandable implant M with at least two expandable implant branches MB-a, MB-b in a patient lumen L having at least two patient lumen branches LB-a, LB-b over at least two guidewires 2890a, 2890b, while maintaining and protecting wire access across all respective patient lumen branches LB-a, LB-b. For example, at least one of the second guidewire distal ends 2888a, 2888b, the at least one outer sheath open tip 540a, 540b, the at least two outer sheath open slits 548a, 584b, when provided, the at least two shaft branches 112a, 112b, the at least two expandable implant branches MB-a, MB-b, and the inner sheath <NUM>, when provided, allows the user to deploy a bifurcated expandable implant M while maintaining and protecting guidewire 2890a, 2890b access across all respective patient lumen branches LB-a, LB-b because portions of the implant delivery system <NUM> may be inserted and removed from the target patient tissue site T without the substantial loss of access to all respective patient lumen side branches B.

It is contemplated that the shaft <NUM> having at least two shaft lumens 126a, 126b may at least partially assist the user with preventing the corresponding guidewires 2890a, 2890b from becoming entangled with one another when each guidewire proximal end 2892a, 2892b is inserted through a respective shaft lumen 126a, 126b.

It is contemplated that at least one of the alternate outer sheath <NUM> configurations, the alternate shaft <NUM> configurations, the alternate inner sheath <NUM> configurations, when provided, and the bifurcated expandable implant M, when provided, of the implant delivery system <NUM> may be prearranged, and/or prepackaged, prior to use. For example, a shaft <NUM> may be prearranged with an outer sheath <NUM> such that the shaft <NUM> is positioned within the outer sheath lumen <NUM> with at least a portion of the shaft body <NUM> and the inner sheath <NUM> being radially adjacent to at least a portion of the outer sheath body <NUM>, at least a portion of each of the shaft branches 112a, 112b being positioned radially adjacent to a respective outer sheath branch 546a, 546b, when provided, and each of the nosecones 118a, 118b, when provided, being longitudinally adjacent to a respective outer sheath open tip 540a, 540b.

Although the expandable implant M has been described as being a bifurcated expandable implant M having at least two expandable implant branches MB-a, MB-b, it is contemplated that the expandable implant M may have one or no expandable implant branches. In such case, one of ordinary skill in the art will understand, given the teachings of the present application, how to deploy any such differently configured expandable implant.

While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means/options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and/or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A "predetermined" status may be determined at any time before the structures being manipulated actually reach that status, the "predetermination" being made as late as immediately before the structure achieves the predetermined status. The term "substantially" is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified--a "substantial" quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations.

Claim 1:
A bifurcated implant delivery system (<NUM>), comprising:
a shaft (<NUM>) having
a shaft proximal end (<NUM>) having at least two shaft proximal openings (<NUM>),
a shaft distal end (<NUM>) having at least two shaft branches (<NUM>) longitudinally extending from a shaft body distal end (<NUM>), each of the shaft branches (<NUM>) having a shaft open tip (<NUM>),
a shaft body (<NUM>) longitudinally extending between the shaft proximal end (<NUM>) and the shaft distal end (<NUM>),
at least one shaft lumen (<NUM>), the at least one shaft lumen (<NUM>) longitudinally extending between a respective shaft proximal opening (<NUM>) and at least one respective shaft open tip (<NUM>), and
a reinforcing element (<NUM>) longitudinally extending from the shaft body distal end (<NUM>), the reinforcing element (<NUM>) being configured to directly contact a bifurcated expandable implant (M) to maintain the bifurcated expandable implant (M) in a predetermined position; and
an outer sheath (<NUM>) having
an outer sheath proximal end (<NUM>) having an outer sheath proximal opening (<NUM>),
an outer sheath distal end (<NUM>) having at least one outer sheath open tip (<NUM>), and
an outer sheath lumen (<NUM>) longitudinally extending between the outer sheath proximal opening (<NUM>) and the at least one outer sheath open tip (<NUM>), the outer sheath lumen (<NUM>) for selectively holding at least a portion of the shaft (<NUM>) and the bifurcated expandable implant (M) therein.