Patent Description:
It is often desirable to use multiple guidewires in various medical procedures involving diseased branched patient lumens. For example, when utilizing stent deployment devices within branched lumens, a first guidewire would be used to access the main lumen while second and/or third guidewires would access the side branch lumens. At least one stent with at least one guidewire port 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 branched patient lumen, the stent may be deployed from the delivery device and expanded.

<CIT> discloses self-expanding bifurcation stents, a delivery sleeve for such stents and a method of delivery of such stents.

The invention is defined in the independent claim. Optional features are defined in the dependent claims. According to the invention, an implant delivery system is provided. An outer sheath has an outer sheath proximal end having an outer sheath proximal opening. An outer sheath distal end has an outer sheath open tip. The outer sheath has an outer sheath outer surface. An outer sheath lumen extends between the outer sheath proximal opening and the outer sheath open tip. The outer sheath lumen is for selectively holding at least one expandable implant therein. At least one outer sheath side wall opening selectively places the outer sheath outer surface in fluid communication with the outer sheath lumen. At least one outer sheath open slit extends at least partially between the outer sheath open tip and a respective outer sheath side wall opening. A shaft has a shaft proximal end having a shaft proximal opening. A shaft distal end has a shaft open tip. The shaft has a shaft outer surface and at least one shaft lumen. At least one shaft side wall opening selectively places the shaft outer surface in fluid communication with the at least one shaft lumen. When the shaft is operably joined to the outer sheath, at least a portion of the at least one shaft side wall opening is selectively aligned with a respective outer sheath side wall opening.

There is also disclosed a method for deploying an expandable implant in a patient lumen. An implant delivery system is provided. An outer sheath has an outer sheath proximal end having an outer sheath proximal opening. An outer sheath distal end has an outer sheath open tip. The outer sheath has an outer sheath outer surface. An outer sheath lumen extends between the outer sheath proximal opening and the outer sheath open tip. The outer sheath lumen is for selectively holding at least one expandable implant therein. At least one outer sheath side wall opening selectively places the outer sheath outer surface in fluid communication with the outer sheath lumen. At least one outer sheath open slit extends at least partially between the outer sheath open tip and a respective outer sheath side wall opening. A shaft has a shaft proximal end having at least one shaft proximal opening. A shaft distal end has a shaft open tip. The shaft has a shaft outer surface and at least one shaft lumen. At least one shaft side wall opening selectively places the shaft outer surface in fluid communication with the at least one shaft lumen. At least one expandable implant has at least one expandable implant side wall opening is provided. The at least one collapsed expandable implant is mounted circumferentially on the shaft outer surface. With the at least one collapsed expandable implant mounted on the shaft, at least a portion of the expandable implant side wall opening is aligned with at least a portion of a respective shaft side wall opening. The at least one collapsed expandable implant and at least a portion of the shaft are collectively inserted into at least a portion of the outer sheath lumen. With the at least one expandable implant and at least a portion of the shaft inserted into the outer sheath lumen, the shaft is aligned in the outer sheath lumen with at least a portion of the at least one shaft side wall opening being aligned with at least a portion of a respective outer sheath side wall opening. At least one guidewire distal end is inserted into a target patient tissue site in a patient lumen. At least one guidewire proximal end is directed through the implant delivery system. The implant delivery system is directed to the target patient tissue site along the at least one guidewire. With the implant delivery system at the target patient tissue site, the at least one expandable implant is exposed by directing the outer sheath in the longitudinally proximal direction, while maintaining each of the at least one guidewire, the at least one expandable implant and the shaft at the target patient tissue site. With the at least one expandable implant exposed, the properties of the at least one expandable implant are utilized to move the at least one expandable implant toward an expanded condition.

For a better understanding, reference may be made to the accompanying drawings, in which:.

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," etc., another element, it may be directly on, attached to 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" 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.

The invention comprises, consists of, or consists essentially of the following features, in any combination.

An implant delivery system <NUM> is provided. The implant delivery system 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 term "longitudinal" is used herein to indicate a substantially horizontal direction, in the orientation of <FIG>. The outer sheath proximal end <NUM> has an outer sheath proximal opening <NUM>. The outer sheath distal end <NUM> has an outer sheath open tip <NUM>. The outer sheath <NUM> has an outer sheath outer surface <NUM> and an outer sheath lumen <NUM>. The outer sheath lumen <NUM> longitudinally extends between the outer sheath proximal opening <NUM> and the outer sheath open tip <NUM>. The outer sheath lumen <NUM> is at least partially configured for selectively holding at least one expandable implant M therein, as will be described later. The expandable implant M may be a stent, a stent-graft, an embolization coil, an embolization plug, a shunt closure device, a cardiovascular valve, a percutaneous valve, any self-expandable device, any other expandable device, or any combination thereof.

As shown in <FIG>, at least a portion of the outer sheath distal end <NUM> may be inwardly tapered. 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 diameter of the outer sheath distal end <NUM> in <FIG>. The term "inward" is defined herein as a taper that becomes gradually smaller, such as shown as the gradual diminution in diameter between the outer sheath body <NUM> and the outer sheath open tip <NUM> in <FIG>. Further, the inward taper, such as the taper of the outer sheath distal end <NUM>, could include no expansion in diameter (or even an outward taper) distal to the outer sheath body <NUM>. At least one of the inwardly tapered outer sheath distal end <NUM> and the outer sheath open tip <NUM> may be elastically expandable to allow the passage of at least one of an expandable implant M and a shaft <NUM>, as will be described later, therethrough. As shown in <FIG>, the outer sheath distal end <NUM> might not be inwardly tapered. Thus, the outer sheath distal end <NUM> and the outer 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 outer sheath distal end <NUM> not having a gradual or stepwise diminution and/or increase in diameter in <FIG>.

As shown in <FIG>, at least one of the outer sheath body <NUM> and the outer sheath distal end <NUM> has at least one outer sheath side wall opening <NUM> (shown here as outer sheath side wall openings 418a, 418b, and 418c) and at least one outer sheath open slit <NUM> (shown here as outer sheath open slits 420a, 420b, and 420c). The at least one outer sheath side wall opening 418a, 418b, and 418c selectively places the outer sheath outer surface <NUM> in fluid communication with the outer sheath lumen <NUM>. The at least one outer sheath open slit 420a, 420b, and 420c extends at least partially between the outer sheath open tip <NUM> and a respective outer sheath side wall opening 418a, 418b, and 418c. Each outer sheath open slit 420a, 420b, and 420c may have an outer sheath open slit first surface <NUM> (shown here as outer sheath open slit first surfaces 422a, 422b, and 422c) and an outer sheath open slit second surface <NUM> (shown here as outer sheath open slit second surfaces 424a, 424b, and 424c). The outer sheath open slit first surface 422a, 422b, 422c oppositely faces and circumferentially abuts the outer sheath open slit second surface 424a, 424b, 424c. The term "circumferentially" is defined herein as at least partially surrounding the external boundary or surface of a figure or object. The outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c may be selectively elastically separable. That is, a force may be applied to separate the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c, as that the outer sheath open slit first surface 422a, 422b, 422c will no longer be abutting the outer sheath open slit second surface 424a, 424b, 424c. However, upon the removal of the separating force, the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c will return to their original abutting position due to the elastic nature of the material forming the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c. Alternatively, instead of abutting, the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c may radially overlap to provide a labyrinth-type seal (not shown). 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 central longitudinal axis LA, in the orientation of <FIG>.

Instead of abutting and/or overlapping, at least a portion of the outer sheath open slit first surface 422a, 422b, 422c may be radially spaced from at least a portion of the outer sheath open slit second surface 424a, 424b, 424c. The space between the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c may be configured to allow the passage of at least a portion of a guidewire <NUM> therethrough. When the outer sheath open slit 420a, 420b, 420c has radially spaced outer sheath open slit first and second surfaces 422a, 422b, 422c, 424a, 424b, 424c, the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c may be selectively elastically separable. That is, a force may be applied to separate at least a portion of the outer sheath open slit first surface 422a, 422b, 422c even further apart from at least a portion of the outer sheath open slit second surface 424a, 424b, 424c, as that the radial spacing between at least a portion of the outer sheath open slit first and second surfaces 422a, 422b, 422c, 424a, 424b, 424c 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 open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c will return to their pre-separating force radial spacing due to the elastic nature of the material forming the outer sheath open slit first surface 422a, 422b, 422c and the outer sheath open slit second surface 424a, 424b, 424c.

<FIG> depicts the outer sheath <NUM> having one outer sheath side wall opening 418a and one outer sheath open slit 420a that extends at least partially between the outer sheath open tip <NUM> and the outer sheath side wall opening 418a. <FIG> depict the outer sheath <NUM> having a plurality of outer sheath side wall openings 418a, 418b, 418c and a plurality of outer sheath open slits 420a, 420b, 420c. Each of the outer sheath open slits 420a, 420b, 420c longitudinally extends between the outer sheath open tip <NUM> and a respective outer sheath side wall opening 418a, 418b, 418c. Each of the outer sheath side wall openings 418a, 418b, 418c and respective outer sheath open slits 420a, 420b, 420c, may be circumferentially offset from the other outer sheath side wall openings 418a, 418b, 418c and respective outer sheath open slits 420a, 420b, 420c on at least one of the outer sheath body <NUM> and the outer sheath distal end <NUM>.

<FIG> depicts the outer sheath <NUM> having a plurality of outer sheath side wall openings 418a, 418b, 418c arranged in parallel on at least one of the outer sheath body <NUM> and the outer sheath distal end <NUM>. The outer sheath <NUM> of <FIG> further has an outer sheath open slit <NUM> longitudinally extending from the outer sheath open tip <NUM>, through at least one outer sheath side wall opening 418a, 418b of the plurality of outer sheath side wall openings 418a, 418b, 418c, and to another of the outer sheath side wall openings 418c. The at least one of the plurality of side wall openings 418a, 418b, 418c through which the outer sheath open slit <NUM> extends may form a portion of the outer sheath open slit <NUM>. For example, as shown in <FIG>, the outer sheath open slit <NUM> longitudinally extends from the outer sheath open tip <NUM>, through first and second outer sheath side wall openings 418a, 418b, and to a third outer sheath side wall opening 418c. In such case, the first and second outer sheath side wall openings 418a, 418b may form a portion of the outer sheath open slit <NUM>, and accordingly may form at least a portion of the outer sheath open slit first and second surfaces <NUM>, <NUM>.

As shown in <FIG>, the outer sheath <NUM> may have at least one c-clip <NUM> (shown here as c-clips 826a, 826b, and 826c) or other circumferentially extending reinforcing structure embedded in the outer sheath <NUM> radially between the outer sheath outer surface <NUM> and the outer sheath lumen <NUM> and radially adjacent to a respective outer sheath open slit 420a, 420b, 420c. Instead of, or in addition to, the at least one c-clip 826a, 826b, and 826c being embedded in the outer sheath <NUM>, the at least one c-clip 826a, 826b, and 826c may be selectively disposed on a portion of the outer sheath outer surface <NUM> that is adjacent to a respective outer sheath open slit 420a, 420b, 420c. Alternatively, or in addition to the above, the at least one c-clip 826a, 826b, and 826c 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 420a, 420b, 420c.

The c-clip 826a, 826b, and 826c at least partially selectively restricts the outer sheath open slit first surface 422a, 422b, 422c from elastically separating from the outer sheath open slit second surface 424a, 424b, 424c when an expandable implant M, such as, but not limited to, a self-expanding implant, is disposed within the outer sheath lumen <NUM>. 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 422a, 422b, 422c is elastically separable from the outer sheath open slit second surface 424a, 424b, 424c, the movement of the expandable implant M toward the expanded condition might tend to cause the outer sheath open slit first surface 422a, 422b, 422c to elastically separate from the outer sheath open slit second surface 424a, 424b, 424c in an unwanted manner. However, as shown in <FIG>, when the at least one c-clip 826a, 826b, and 826c is embedded in the outer sheath <NUM>, the at least one c-clip 826a, 826b, and 826c provides a radially inward pressure or bias to at least partially selectively restrict/inhibit/prevent the expandable implant M from moving from a collapsed condition toward an expanded condition, and thus at least partially restricts/inhibits/prevents the expandable implant M from elastically separating the outer sheath open slit first surface 422a, 422b, 422c from the outer sheath open slit second surface 424a, 424b, 424c. The at least one c-clip 826a, 826b, and 826c 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.

Instead of, or in addition to, the outer sheath <NUM> having at least one c-clip 826a, 826b, and 826c to at least partially selectively restrict a respective outer sheath open slit first surface 422a, 422b, 422c from elastically separating from a respective outer sheath open slit second surface 424a, 424b, 424c, the outer sheath <NUM> may have at least one reinforcing element <NUM> or other circumferentially extending reinforcing structure. As shown in <FIG>, the at least one reinforcing element <NUM> may be radially embedded in the outer sheath <NUM> between the outer sheath outer surface <NUM> and the outer sheath lumen <NUM> and radially adjacent to the at least one outer sheath open slit 420a, 420b, 420c. Instead of, or in addition to, the at least one reinforcing element <NUM> being embedded in the outer sheath <NUM>, the at least one reinforcing element <NUM> may be selectively disposed on a portion of the outer sheath outer surface <NUM> that is adjacent to a respective outer sheath open slit 420a, 420b, 420c. Alternatively, or in addition to the above, the at least one reinforcing element <NUM> 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 420a, 420b, 420c.

The at least one reinforcing element <NUM> may at least partially longitudinally extend between at least one outer sheath side wall opening 418a, 418b, 418c and the outer sheath open tip <NUM> to at least partially reinforce a portion of the outer sheath <NUM> adjacent to the at least one outer sheath open slit 420a, 420b, 420c by at least partially selectively restricting a respective outer sheath open slit first surface 422a, 422b, 422c from elastically separating from a respective outer sheath open slit second surface 424a, 424b, 424c, in a similar manner as previously described in regard to the at least one c-clip 826a, 826b, and 826c. The at least one reinforcing element <NUM> may be at least partially radiopaque, and thus visible under radiography or other intraoperative imaging-guided techniques to assist with imaging placement and/or orientation.

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 shaft proximal end <NUM> may have at least one shaft proximal opening <NUM>. The shaft distal end <NUM> may have a shaft open tip <NUM>. The shaft <NUM> may have a shaft outer surface <NUM> and at least one shaft lumen <NUM> (shown here as shaft lumens 1044a and 1044b). At least a portion of the shaft outer surface <NUM> may be configured for selectively circumferentially mounting an expandable implant M thereon, as will be described below. The shaft <NUM> has at least one shaft side wall opening <NUM> selectively placing the shaft outer surface <NUM> in fluid communication with the at least one shaft lumen 1044b.

As shown in <FIG>, the shaft distal end <NUM> may have a nosecone <NUM>. 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. The nosecone <NUM> may point, or narrow, in the longitudinally distal direction (shown as an arrow "X" in <FIG>). The nosecone <NUM> may be configured to substantially prevent the egress of an expandable implant M mounted circumferentially on the shaft outer surface <NUM> from a desired position on the shaft outer surface <NUM>. The nosecone <NUM> may also or instead, be used for a smooth atraumatic transition of the implant delivery system <NUM> into a target patient tissue site T. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the nosecone <NUM>, to show the structural features of the shaft <NUM> having the nosecone <NUM> in <FIG>.

As shown in <FIG> the nosecone <NUM> may have at least one elastic skirt <NUM> that longitudinally extends in the proximal direction (shown as an arrow "Y" in <FIG>). The elastic skirt <NUM> is for selectively restricting an outer sheath open slit first surface <NUM> from elastically separating from a respective outer sheath open slit second surface <NUM> when the shaft <NUM> is operably joined to the outer sheath <NUM>, as will be described in more detail below. The elastic skirt <NUM> is capable of moving between a collapsed condition (<FIG>) and an expanded condition (<FIG>). <FIG> depict cross-sectional views of various points along the shaft <NUM> having the elastic skirt <NUM> in the expanded condition, to show the structural features of the shaft <NUM> having the elastic skirt <NUM> in the expanded condition in <FIG>.

As shown in <FIG>, the shaft distal end <NUM> might not have a nosecone <NUM>. In such case, the shaft distal end <NUM> and the shaft body <NUM> may be substantially level. <FIG> depicts a cross-sectional view of a point along the shaft <NUM> having a shaft distal end <NUM> and a shaft body <NUM> that are substantially level, to show the structural features of the shaft <NUM> having a shaft distal end <NUM> and a shaft body <NUM> that are substantially level in <FIG>.

As shown in <FIG>, the shaft <NUM> may have a shaft first lumen <NUM> and at least one shaft second lumen <NUM> (shown here as shaft second lumens 1554a, 1554b, and 1554c). The shaft first lumen <NUM> may longitudinally extend between the shaft open tip <NUM> and at least one of the shaft proximal end <NUM> and the at least one shaft proximal opening <NUM>. The at least one shaft second lumen 1554a, 1554b, and 1554c may longitudinally extend between a respective shaft side wall opening <NUM> (shown here as shaft side wall openings 1046a, 1046b, and 1046c) and at least one of the shaft proximal end <NUM> and the at least one of the shaft proximal opening <NUM>. The shaft first and second lumens <NUM>, 1554a, 1554b, 1554c may share a common shaft proximal opening <NUM>, and/or may each have a respective proximal opening <NUM>. The shaft side wall opening 1046a, 1046b, 1046c may selectively place the shaft outer surface <NUM> in fluid communication with a respective shaft second lumen 1554a, 1554b, 1554c. For example, <FIG> depicts a shaft <NUM> having the shaft first lumen <NUM> and one shaft second lumen 1554a that extends between at least one of the shaft proximal end <NUM> and the shaft proximal opening <NUM> and a respective shaft side wall opening 1046a. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the shaft first lumen <NUM> and the shaft second lumen 1554a, to show the structural features of the shaft <NUM> having the shaft first lumen <NUM> and the shaft second lumen 1554a in <FIG>.

<FIG> depict the shaft <NUM> having the shaft first lumen <NUM> and a plurality of shaft second lumens 1554a, 1554b, 1554c. Each of the shaft second lumens 1554a, 1554b, 1554c longitudinally extends between a respective shaft side wall opening 1046a, 1046b, 1046c and at least one of the shaft proximal end <NUM>, a common shaft proximal opening <NUM>, and a respective shaft proximal opening <NUM>. Each of the shaft side wall openings 1046a, 1046b, 1046c selectively places the shaft outer surface <NUM> in fluid communication with a respective shaft second lumen 1554a, 1554b, 1554c. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the shaft first lumen <NUM> and a plurality of shaft second lumens 1554a, 1554b, to show the structural features of the shaft <NUM> having the shaft first lumen <NUM> and a plurality of shaft second lumens 1554a, 1554b in <FIG>. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the shaft first lumen <NUM> and a plurality of shaft second lumens 1554a, 1554b, 1554c, to show the structural features of the shaft <NUM> having the shaft first lumen <NUM> and a plurality of shaft second lumens 1554a, 1554b, 1554c in <FIG>. Instead of the shaft <NUM> having a shaft first lumen <NUM> and at least one shaft second lumen 1554a, 1554b, 1554c for allowing the passage of at least one guidewire <NUM> (shown here as guidewires 1856a, 1856b, 1856c, and 1856d), as shown in <FIG>, the shaft <NUM> may have one shaft lumen <NUM> that substantially functions as both the shaft first lumen <NUM> and the at least one shaft second lumen 1554a, 1554b, 1554c, as shown in <FIG>. In such case, the shaft <NUM> may have at least one shaft side wall opening 1046a, 1046b, 1046c that places the shaft outer surface <NUM> in fluid communication with the shaft lumen <NUM>.

As shown in <FIG>, at least a portion of shaft outer surface <NUM> adjacent to the at least one shaft side wall opening 1046a may be substantially flush with the shaft outer surface <NUM> on at least one of the shaft proximal end <NUM>, the shaft distal end <NUM>, and the shaft body <NUM>. The term "flush" is defined herein as being substantially similar in profile, and without significant radial discrepancies. <FIG> depict cross-sectional views of various points along the shaft <NUM> having at least a portion of the shaft outer surface <NUM> adjacent to the at least one shaft side wall opening 1046a being substantially flush, to show the structural features of the shaft <NUM> having at least a portion of the shaft outer surface <NUM> adjacent to the at least one shaft side wall opening 1046a being substantially level in <FIG>.

Instead of, or in addition to, at least a portion of shaft outer surface <NUM> adjacent to the at least one shaft side wall opening <NUM> being substantially flush, the shaft <NUM> may have at least one shaft projection <NUM> (shown as shaft projections 2158a, 2158b, and 2158c) substantially radially extending from the shaft outer surface <NUM> at a respective shaft side wall opening 1046a, 1046b, 1046c, as shown in <FIG>. In such case, when the shaft <NUM> is operably joined to the outer sheath <NUM>, the at least one shaft projection 2158a, 2158b, and 2158c may at least partially extend into, and/or extend through, a respective outer sheath side wall opening 418a, 418b, 418c, as will be described below. The at least one shaft projection 2158a, 2158b, and 2158c may be configured to facilitate the separation of an outer sheath open slit first surface <NUM> and an outer sheath open slit second surface <NUM> of a respective outer sheath open slit 420a, 420b, 420c, as will be discussed below.

As shown in <FIG>, the at least one shaft projection 2158a, 2158b, and 2158c may have a shaft projection open tip <NUM> and a shaft projection lumen <NUM> that extends from the shaft side wall opening 1046a to the shaft projection open tip <NUM>. The shaft projection lumen <NUM> may selectively place the shaft projection open tip <NUM> in fluid communication with the at least one of the shaft lumen <NUM>, such as the shaft first lumen <NUM> and the at least one shaft second lumen 1554a. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the at least one shaft projection 2158a, to show the structural features of the shaft <NUM> having the at least one projection 2158a, as depicted in <FIG>. <FIG> depict cross-sectional views of various points along the shaft <NUM> having the at least one projection 2158a, to show the structural features of the shaft <NUM> having the at least one shaft projection 2158a, as depicted in <FIG>.

As shown in <FIG>, each shaft side wall opening 1046a, 1046b, 1046c of the shaft <NUM> having a plurality of shaft side wall openings 1046a, 1046b, 1046c may be circumferentially offset from one another on at least one of the shaft body <NUM> and the shaft distal end <NUM>. In such case, as shown in <FIG>, each shaft projection 2158a, 2158b, and 2158c, when provided, at a respective shaft side wall opening 1046a, 1046b, 1046c may accordingly be circumferentially offset from the other shaft projections 2158a, 2158b, and 2158c on at least one of the shaft body <NUM> and the shaft distal end <NUM>. As shown in <FIG>, instead of, or in addition to, each shaft side wall opening 1046a, 1046b, 1046c being circumferentially offset from one another on at least one of the shaft body <NUM> and the shaft distal end <NUM>, each shaft side wall opening 1046a, 1046b, 1046c may be circumferentially aligned on at least one of the shaft body <NUM> and the shaft distal end <NUM>. In such case, as shown in <FIG>, each shaft projection 2158a, 2158b, and 2158c at a respective shaft side wall opening 1046a, 1046b, 1046c may accordingly be circumferentially aligned on at least one of the shaft body <NUM> and the shaft distal end <NUM>.

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>. For the sake of brevity, not every possible combination of the alternate configurations of the outer sheath <NUM> and the alternate configurations of the shaft <NUM> 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 an inwardly tapered outer sheath distal end <NUM> operably joined to the shaft <NUM> having a substantially level shaft distal end <NUM> and shaft body <NUM>. When the implant delivery system <NUM> is in the configuration shown in <FIG>, at least one of the shaft body <NUM> and the shaft distal end <NUM> may be positioned within the outer sheath lumen <NUM>.

<FIG> depicts the outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM> operably joined to the shaft <NUM> having a nosecone <NUM>. When the implant delivery system <NUM> is in the configuration shown in <FIG>, at least one of the shaft body <NUM> and the shaft distal end <NUM> may be positioned within the outer sheath lumen <NUM>. The nosecone <NUM> may be longitudinally adjacent to the outer sheath open tip <NUM>.

<FIG> depicts the outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM> operably joined to the shaft <NUM> having a nosecone <NUM> with at least one elastic skirt <NUM>. When the implant delivery system <NUM> is in the configuration shown in <FIG>, at least one of the shaft body <NUM> and the shaft distal end <NUM> may be positioned within the outer sheath lumen <NUM>. The nosecone <NUM> may be longitudinally adjacent to the outer sheath open tip <NUM>. The at least one elastic skirt <NUM> may be disposed on outer sheath outer surface <NUM> to at least partially selectively restricts/inhibits/prevents the outer sheath open slit first surface <NUM> from at least partially elastically separating from the outer sheath open slit second surface <NUM> when an self-expanding implant M is disposed within the outer sheath lumen <NUM>.

In other words, a collapsed expandable implant M placed within the outer sheath lumen <NUM> may tend to want to move toward an expanded condition due to the natural properties of the expandable implant M. Because the outer sheath open slit first surface <NUM> is elastically separable from the outer sheath open slit second surface <NUM>, the movement of the expandable implant M toward the expanded condition may cause the outer sheath open slit first surface <NUM> to at least partially elastically separate from the outer sheath open slit second surface <NUM>. However, as shown in <FIG>, when at least one elastic skirt <NUM> is positioned on the outer sheath outer surface <NUM>, the elastic skirt <NUM> provides a radially inward force to at least partially restrict/inhibit/prevent the expandable implant M from at least partially elastically separating the outer sheath open slit first surface <NUM> from the outer sheath open slit second surface <NUM>.

<FIG> depicts the outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM> operably joined to the shaft <NUM> having a substantially flush portion of the shaft outer surface <NUM> adjacent to the at least one shaft side wall opening 1046a. When the implant delivery system <NUM> is in the configuration shown in <FIG>, at least one of the shaft body <NUM> and the shaft distal end <NUM> may be positioned within the outer sheath lumen <NUM> and at least a portion of the at least one shaft side wall opening 1046a may be selectively aligned with a respective outer sheath side wall opening 418a. The shaft outer surface <NUM> may have an expandable implant M disposed, alternatively referred to mounted, thereon, wherein the outer sheath lumen <NUM> at least partially restricts/inhibits/prevents the expandable implant M from moving from a collapsed condition toward an expanded condition. The expandable implant M may have at least one expandable implant side wall opening MO (shown here as MO-a) that is at least partially selectively aligned with at least one of a respective shaft side wall opening 1046a and a respective outer sheath side wall opening 418a when the expandable implant M is operatively joined to the shaft <NUM> and the outer sheath <NUM>. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the shaft <NUM>, and the expandable implant M in <FIG>.

<FIG> depicts the outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM> operably joined to the shaft <NUM> having the at least one shaft projection 2158a. When the implant delivery system <NUM> is in the configuration shown in <FIG>, at least one of the shaft body <NUM> and the shaft distal end <NUM> may be positioned within the outer sheath lumen <NUM>, at least a portion of the at least one shaft side wall opening 1046a may be selectively aligned with a respective outer sheath side wall opening 418a, and at least a portion of the at least one shaft projection 2158a may at least partially extend into (<FIG>), and/or extend through (<FIG>), a respective outer sheath side wall opening 418a. The shaft outer surface <NUM> may have an expandable implant M disposed thereon, wherein the outer sheath lumen <NUM> at least partially restricts/inhibits/prevents the expandable implant M from moving from a collapsed condition toward an expanded condition. The expandable implant M may have the at least one expandable implant side wall opening MO (shown here as MO-a) that is at least partially selectively aligned with at least one of a respective shaft side wall opening 1046a and a respective outer sheath side wall opening 418a when the expandable implant M is operatively joined to the shaft <NUM> and the outer sheath <NUM>. The at least one shaft projection 2158a may at least partially extend into (<FIG>), and/or extend through (<FIG>), a respective outer sheath side wall opening 418a, through a respective expandable implant side wall opening MO-a. <FIG> depict cross-sectional views of various points along the implant delivery system <NUM>, to show the arrangement of the outer sheath <NUM>, the shaft <NUM>, the at least one shaft projection 2158a, and the expandable implant M depicted 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 shaft <NUM>, the at least one shaft projection 2158a, and the expandable implant M depicted in <FIG>.

In use, the 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>, and any configuration of the shaft <NUM>, or a combination of individual features described above for the alternate configurations of the outer sheath <NUM> and the shaft <NUM>. For the sake of brevity, not every possible combination of the alternate configurations of the outer sheath <NUM> and the alternate configurations of the shaft <NUM> 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> and the shaft <NUM> that one of ordinary skill in the art could devise, based upon the present teachings.

<FIG> depict an example sequence of operation of the implant delivery system <NUM> including a shaft <NUM> having a nosecone <NUM> with the at least one elastic skirt <NUM>, the shaft first lumen <NUM>, and a plurality of shaft second lumens 1554a, 1554b, 1554c, and an outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM>, a plurality of outer sheath side wall openings 418a, 418b, 418c, and a plurality of outer sheath open slits 420a, 420b, 420c corresponding to the plurality to the outer sheath side wall openings 418a, 418b, 418c. At least one expandable implant M, which can be self-expandable and/or expand through external means (e.g., a balloon), having at least one expandable implant side wall opening MO, may be provided. For example, an expandable implant M having a plurality of expandable implant side wall openings MO-a, MO-b, MO-c may be provided.

As shown in <FIG>, a collapsed expandable implant M may be placed in operative engagement with the shaft outer surface <NUM>. In particular, the expandable implant M may be mounted circumferentially on the shaft outer surface <NUM>. With the collapsed expandable implant M mounted on the shaft <NUM>, at least a portion of the at least one expandable implant side wall opening MO, e.g., the plurality of expandable implant side wall openings MO-a, MO-b, MO-c, as shown in <FIG>, may be aligned with at least a portion of a respective shaft side wall opening 1046a, 1046b, 1046c. When the shaft <NUM> has the at least one shaft projection <NUM> at a respective shaft side wall opening <NUM>, the expandable implant M may be aligned with the shaft <NUM> with the at least one expandable implant side wall opening MO-a, MO-b, MO-c aligned with a respective shaft side wall opening 1046a, 1046b, 1046c and the at least one shaft projection 2158a, 2158b, 2158c at least partially extending into, and/or extending through, a respective implant side wall opening MO-a, MO-b, MO-c.

As shown in <FIG>, with the collapsed expandable implant M mounted to the shaft outer surface <NUM>, at least one of the collapsed expandable implant M and at least a portion of the shaft <NUM> may be collectively inserted at least partially into the outer sheath lumen <NUM>. Alternatively, instead of mounting the expandable implant M to the shaft outer surface <NUM> prior to inserting at least a portion of the shaft <NUM> into the outer sheath lumen <NUM>, the collapsed expandable implant M may be placed within the outer sheath lumen <NUM> prior to inserting at least a portion of the shaft <NUM> into the outer sheath lumen <NUM>. In such case, after at least a portion of the shaft <NUM> is inserted into the outer sheath lumen <NUM>, the collapsed expandable implant M may be placed in operative engagement with the shaft <NUM> by mounting the expandable implant M to the shaft outer surface <NUM>.

With the expandable implant M and at least a portion of the shaft <NUM> at least partially inserted into the outer sheath lumen <NUM>, the shaft <NUM> may be aligned in the outer sheath lumen <NUM> with at least a portion of the at least one shaft side wall opening 1046a, 1046b, 1046c (and accordingly also with at least a portion of the at least one expandable implant side wall opening MO-a, MO-b, MO-c) being aligned with at least a portion of a respective outer sheath side wall opening 418a, 418b, 418c. When the shaft <NUM> has the at least one projection 2158a, 2158b, 2158c at a respective shaft side wall opening 1046a, 1046b, 1046c, the shaft <NUM> may be aligned in the outer sheath lumen <NUM> with at least a portion of the at least one shaft side wall opening 1046a, 1046b, 1046c being aligned with at least a portion of a respective outer sheath side wall opening 418a, 418b, 418c and the at least one shaft projection 2158a, 2158b, 2158c at least partially extending into, and/or extending through, a respective outer sheath side wall opening 418a, 418b, 418c (and accordingly with the at least one shaft projection 2158a, 2158b, 2158c at least partially extending into, and/or extending through, a respective expandable implant side wall opening MO-a, MO-b, MO-c).

When the shaft <NUM> has a nosecone <NUM>, as is shown in <FIG>, the shaft <NUM> may be further aligned in the outer sheath lumen <NUM> with the nosecone <NUM> being longitudinally adjacent to the outer sheath open tip <NUM>. When the shaft <NUM> has a nosecone <NUM> with the at least one elastic skirt <NUM>, as is shown in <FIG>, the elastic skirt <NUM> may be operatively engaged to the outer sheath <NUM> by placing the elastic skirt <NUM> on at least a portion of the outer sheath outer surface <NUM> adjacent to the outer sheath open tip <NUM>. When the elastic skirt <NUM> is operatively engaged to the outer sheath <NUM>, the elastic skirt <NUM> is held in the expanded condition by the outer sheath <NUM>. As described above, the elastic skirt <NUM> at least partially selectively restricts or inhibits the outer sheath open slit first surface <NUM> from elastically separating from the outer sheath open slit second surface <NUM> when the expandable implant M is disposed within the outer sheath lumen <NUM>.

As shown in <FIG>, at least one guidewire distal end <NUM> (shown here as 3664a, 3664b, 3664c, and 3664d) is inserted into a target patient tissue site T in a patient lumen L. In particular, a first guidewire distal end 3664a is inserted into the target patient tissue site T in the patient lumen L, and at least one second guidewire distal end 3664b, 3664c, 3664d is inserted into a respective patient lumen side branch B adjacent to the target patient tissue site T. <FIG> depicts each of second guidewire distal ends 3664b, 3664c, 3664d of the plurality of second guidewire distal ends 3664b, 3664c, 3664d inserted into respective patient lumen side branches B (shown here as B-a, B-b, B-c). At least one guidewire proximal end <NUM> (shown here as 3666a, 3666b, 3666c, 3666d) is directed through the implant delivery system <NUM> and the implant delivery system <NUM> is directed to the target patient tissue site T along the at least one guidewire <NUM>. In particular, a first guidewire proximal end 3666a may be directed through the shaft first lumen <NUM>, at least one second guidewire proximal end 3666b, 3666c, 3666d may be directed through at least one of a respective outer sheath side wall opening 418a, 418b, 418c, a respective expandable implant side wall opening MO-a, MO-b, MO-c, a respective shaft side wall opening 1046a, 1046b, 1046c, and a respective shaft second lumen 1554a, 1554b, 1554c and the implant delivery system <NUM> may be directed to the target patient tissue site T along the first guidewire 1856a and the at least one second guidewire 1856b, 1856c, 1856c. <FIG> depicts the implant delivery system <NUM>, having been inserted through the vasculature and depicted at the target patient tissue site, with each of the second guidewire proximal ends 3666b, 3666c, 3666d of the plurality of second guidewire proximal ends 3666b, 3666c, 3666d inserted through a respective outer sheath side wall opening 418a, 418b, 418c, a respective expandable implant side wall opening MO-a, MO-b, MO-c, a respective shaft side wall opening 1046a, 1046b, 1046c, and a respective shaft second lumen 1554a, 1554b, 1554c.

As shown in <FIG>, the implant delivery system <NUM> may be radially aligned at the target patient tissue site T with the at least one outer sheath side wall opening 418a, 418b, 418c (and accordingly a respective shaft side wall opening 1046a, 1046b, 1046c and a respective expandable implant side wall opening MO-a, MO-b, MO-c) being at least partially aligned with a respective patient lumen side branch B-a, B-b, B-c having a respective second guidewire distal end 3664b, 3664c, 3664d inserted therein. When the shaft <NUM> has the at least one shaft projection 2158a, 2158b, 2158c at a respective shaft side wall opening 1046a, 1046b, 1046c, the implant delivery system <NUM> may be radially aligned at the target patient tissue site T with the at least one outer sheath side wall opening 418a, 418b, 418c being at least partially aligned with a respective patient lumen side branch B-a, B-b, B-c and at least a portion of the at least one shaft projection 2158a, 2158b, 2158c extending into at least a portion of a respective patient lumen side branch B-a, B-b, B-c having a respective second guidewire distal end 3664b, 3664c, 3664d inserted therein. However, certain configurations of shaft projections 2158a, 2158b, 2158c may not extend into a respective patient lumen side branch B-a, B-b, B-c when the implant delivery system <NUM> having the shaft <NUM> with the at least one shaft projection 2158a, 2158b, 2158c is radially aligned at the target patient tissue site T.

As shown in <FIG>, with the implant delivery system <NUM> at the target patient tissue site T, the expandable implant M may be exposed by directing the outer sheath <NUM> in the longitudinally proximal direction (as shown as an arrow "Y" in <FIG>). As the outer sheath <NUM> is directed in the longitudinally proximal direction, the outer sheath <NUM> operatively disengages the elastic skirt <NUM>, when provided, which causes the elastic skirt <NUM> to move from the expanded condition (<FIG>) to the collapsed condition (<FIG>). As shown in <FIG>, when the shaft <NUM> does not include the at least one shaft projection 2158a, 2158b, 2158c at a respective shaft side wall opening 1046a, 1046b, 1046c, movement of the outer sheath <NUM> in the longitudinally proximal direction causes at least a portion of the at least one second guidewire 1856b, 1856b, 1856c to move along a respective outer sheath open slit 420a, 420b, 420c to selectively elastically separate a respective outer sheath open slit first surface 422a, 422b, 422c from a respective outer sheath open slit second surface 424a, 424b, 424c and accordingly permit the outer sheath <NUM> to be directed in the longitudinally proximal direction, while maintaining each of the first guidewire 1856a, the at least one expandable implant M, and the shaft <NUM> at the target patient tissue site T and the at least one second guidewire distal end 3664b, 3664c, 3664d in a respective patient lumen side branch B-a, B-b, B-c.

As shown in <FIG>, when the shaft <NUM> includes the at least one shaft projection 2158a, 2158b, 2158c at a respective shaft side wall opening 1046a, 1046b, 1046c, movement of the outer sheath <NUM> in the longitudinally proximal direction causes at least a portion of the at least one shaft projection 2158a, 2158b, 2158c to move along a respective outer sheath open slit 420a, 420b, 420c to selectively elastically separate a respective outer sheath open slit first surface 422a, 422b, 422c from a respective outer sheath open slit second surface 424a, 424b, 424c and accordingly permit the outer sheath <NUM> to be directed in the longitudinally proximal direction, while maintaining each of the first guidewire 1856a, the at least one expandable implant M, and the shaft <NUM> at the target patient tissue site T and at least one of the at least one second guidewire distal end 3664b, 3664c, 3664d and the at least one shaft projection 2158a, 2158b, 2158c (<FIG>) in a respective patient lumen side branch B-a, B-b, B-c. In other words, because the at least one shaft projection 2158a, 2158b, 2158c at least partially extends into, and/or through, a respective outer sheath side wall opening 418a, 418b, 418c before the outer sheath <NUM> is urged in the longitudinally proximal direction, the at least one shaft projection 2158a, 2158b, 2158c moves along a respective outer sheath open slit 420a, 420b, 420c to selectively elastically separate a respective outer sheath open slit first surface 422a, 422b, 422c from a respective outer sheath open slit second surface 424a, 424b, 424c in what could be thought of as an "unzipping"-type process.

With the expandable implant M exposed, the properties of the expandable implant M are utilized to move the at least one expandable implant from the collapsed condition, as shown in <FIG>, toward an expanded condition, as shown in <FIG>. As depicted in <FIG>, with the expandable implant M in the expanded condition, the shaft <NUM>, and/or the at least one guidewire 1856a, 1856b, 1856c, 1856d, may be removed from at least one of the target patient tissue site T and the at least one patient lumen side branch B-a, B-b, B-c.

Alternatively, after the shaft <NUM> has been removed, a secondary device (not shown) may be directed over at least one of the guidewires 1856a, 1856b, 1856c, 1856d to perform a medical procedure with the secondary device at the target patient tissue site T and/or at the at least one patient lumen side branch B-a, B-b, B-c. The secondary device may be a balloon dilation device (not shown) having an expandable balloon (not shown). The balloon dilation device may be positioned with at least a portion of the expandable balloon within a diseased segment of the patient lumen L and/or adjacent to an inner surface of the expandable implant M. The expandable balloon 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 may be deflated. At least one of the balloon dilation device and the at least one guidewire 1856a, 1856b, 1856c, 1856d may then be removed from the target patient tissue site T by moving at least one of the balloon dilation device and the at least one guidewire 1856a, 1856b, 1856c, 1856d in the longitudinally proximal direction.

Although the above description of the example sequence of operation for the implant delivery system <NUM> references the shaft <NUM> having a nosecone <NUM> with the at least one elastic skirt <NUM>, the shaft first lumen <NUM>, and the plurality of shaft second lumens 1554a, 1554b, 1554c, and the outer sheath <NUM> having a substantially level outer sheath distal end <NUM> and outer sheath body <NUM>, the plurality of outer sheath side wall openings 418a, 418b, 418c, and the plurality of outer sheath open slits 420a, 420b, 420c corresponding to the plurality to the outer sheath side wall openings 418a, 418b, 418c, 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> and the outer sheath <NUM>.

Although the above description of the example sequence of operation for the implant delivery system <NUM> describes an expandable implant M having at least one expandable implant side wall opening MO-a, MO-b, MO-c, the implant delivery system <NUM> may instead, or additionally, include at least one expandable implant M having no, or at least one, expandable implant side wall opening MO. For example, as shown in <FIG>, the implant delivery system <NUM> may have two expandable implants M (shown here as M1 and M2) operatively joined to at least one of the shaft <NUM> and the outer sheath <NUM> in a similar sequence as described above. The expandable implants M may be mounted on longitudinally opposing sides of the of the at least one shaft side wall opening <NUM> (shown here as 1046a). In such case, when the shaft <NUM> and the expandable implants M1, M2 are operatively joined to the outer sheath <NUM>, the expandable implants M1, M2 may be positioned on longitudinally opposite sides of the outer sheath side wall opening <NUM> (shown here as 418a). As shown in <FIG>, this configuration allows the expandable implants M to be deployed individually and serially, in a similar sequence as previously described, at a plurality of target patient tissue sites T (shown here as T1 and T2) in a patient lumen L on longitudinally opposing sides of a respective patient lumen side branch B (shown here as B-a), while a guidewire (shown here as 1856b) maintains access to the respective patient lumen side branch B-a.

It is contemplated that the implant delivery system <NUM> may be custom-made to match the anatomy of a patient lumen L at the target patient tissue site T. For example, the outer sheath <NUM> may be custom-made with at least one of the at least one outer sheath side wall opening <NUM> and the at least one open slit <NUM> being positioned on the outer sheath <NUM> to correspond with the at least one respective patient lumen side branch B-a, B-b, B-c at the target patient tissue site T. The shaft <NUM> may be custom-made with at least one of the at least one shaft side wall opening 1046a, 1046b, 1046c being positioned on the shaft <NUM> to correspond with the at least one respective patient lumen side branch B-a, B-b, B-c at the target patient tissue site T. The expandable implant M may be custom-made with at least one of the at least one expandable implant wall opening MO-a, MO-b, MO-c being positioned on the expandable implant M to correspond with the at least one respective patient lumen side branch B-a, B-b, B-c at the target patient tissue site T.

Instead of, or in addition to, being custom-made, the implant delivery system <NUM> may be designed to in a manner that would correspond with various patient lumen L anatomies at various target patient tissue sites T. For example, as shown in <FIG> the outer sheath <NUM> may have at least one outer sheath open slit <NUM> (shown here as outer sheath open slits 420a, 420b, and 420c). Each outer sheath open slit 420a, 420b, 420c longitudinally extends from the outer sheath open tip <NUM>, through at least one outer sheath side wall opening <NUM> (shown here as outer sheath side wall openings 418a-d, 418e-h, and 418i-l) of a respective plurality of outer sheath side wall openings 418a-d, 418e-h, 418i-l, and to another of the outer sheath side wall openings 418a-d, 418e-h, 418i-l. In such case, one having ordinary skill in the art will appreciate that, given the teachings of the present application, the outer sheath <NUM>, as depicted in <FIG>, may be utilized in conjunction with various of patient lumen L anatomies, various of shaft <NUM> configurations, and/or various expandable implant M configurations.

As shown in <FIG>, the shaft <NUM> may have a shaft first lumen <NUM> and at least one shaft second lumen <NUM> (shown here as shaft second lumens 1554a, 1554b, 1554c). Each shaft second lumen 1554a, 1554b, 1554c may be selectively placed in fluid communication with the shaft outer surface <NUM> through a respective plurality of shaft side wall openings <NUM> (shown here as shaft side wall openings 1046a-d, 1046e-h, and 1046i-l). Thus, each shaft second lumen 1554a, 1554b, 1554c extends between the respective plurality of shaft side wall openings 1046a-d, 1046e-h, and 1046i-l and at least one of the shaft proximal end <NUM>, a common shaft proximal opening <NUM>, and a respective shaft proximal opening <NUM> (shown here as shaft proximal openings 1038b, 1038c, 1038d). In such case, one having ordinary skill in the art will appreciate that, given the teachings of the present application, the shaft <NUM>, as depicted in <FIG>, may be utilized in conjunction with various of patient lumen L anatomies, various outer sheath <NUM> configurations, and/or various expandable implant M configurations.

Any of the alternate outer sheath <NUM> configurations, the alternate shaft <NUM> configurations, the at least one c-clip <NUM>, when provided, the reinforcing element <NUM>, when provided, the nosecone <NUM>, when provided, the elastic skirt <NUM>, when provided, and the at least one shaft projection <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 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 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> and/or within the outer sheath lumen <NUM>. For example, an 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> and/or within the outer sheath lumen <NUM>. When the 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 expandable implant M may at least partially cause the 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 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 an 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 an expandable implant M not made at least partially from a shape memory material would be. An 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 and the alternate shaft <NUM> configurations 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 advance a guidewire 1856a into the target patient tissue site T, advance at least one guidewire 1856b, 1856c, 1856d into a respective patient lumen side branch B-a, B-b, B-c, and then deploy at least one expandable implant M with at least one expandable implant side wall opening MO, and/or multiple expandable implants M with no expandable implant side wall openings MO, in a patient lumen L over the advanced guidewires 1856a, 1856b, 1856c, 1856d, while maintaining and protecting guidewire 1856b, 1856c, 1856d access across all respective patient lumen side branches B. For example, at least one of the second guidewire distal ends 3664b, the at least one outer sheath side wall opening <NUM>, the at least one shaft side wall opening <NUM>, the at least one expandable implant side wall opening MO, and the at least one outer sheath open slit <NUM> allows the user to deploy an expandable stent M while maintaining and protecting guidewire <NUM> access across all respective patient lumen side branches 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. Further, advancing at least one guidewire 1856b, 1856c, 1856d into a respective patient lumen side branch B-a, B-b, B-c may allow a user to keep track of the location of the respective patient lumen side branch B-a, B-b, B-c during the deployment of the expandable implant M.

It is contemplated that the shaft <NUM> having the shaft first lumen <NUM> and the at least one shaft second lumen 1554a, 1554b 1554c may at least partially assist the user with preventing the corresponding guidewires <NUM> from becoming entangled with one another when each guidewire proximal end <NUM> is inserted through a respective shaft first lumen <NUM> and/or a respective shaft second lumen 1554a, 1554b, 1554c.

It is contemplated that at least one of the alternate outer sheath configurations, the alternate shaft configurations, and the expandable implant, when provided, of the implant delivery system <NUM> may be prearranged, and/or prepackaged, prior to use. For example, a shaft may be prearranged with an outer sheath such that at least one shaft projection, when provided, extends at least partially into, and/or through, at least one of a respective expandable implant side wall opening and a respective outer sheath side wall opening.

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. A device incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below.

Claim 1:
An implant delivery system (<NUM>), comprising:
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 an outer sheath open tip (<NUM>),
an outer sheath outer surface (<NUM>),
an outer sheath lumen (<NUM>) extending between the outer sheath proximal opening (<NUM>) and the outer sheath open tip (<NUM>), the outer sheath lumen for selectively holding at least one expandable implant therein,
at least one outer sheath side wall opening (<NUM>) selectively placing the outer sheath outer surface (<NUM>) in fluid communication with the outer sheath lumen (<NUM>), and
at least one outer sheath open slit (<NUM>) extending at least partially between the outer sheath open tip (<NUM>) and a respective outer sheath side wall opening (<NUM>); and
a shaft (<NUM>) having
a shaft proximal end (<NUM>) having at least one shaft proximal opening (<NUM>),
a shaft distal end (<NUM>) having a shaft open tip (<NUM>),
a shaft outer surface (<NUM>),
at least one shaft lumen (<NUM>), and
at least one shaft side wall opening (<NUM>) selectively placing the shaft outer surface (<NUM>) in fluid communication with the at least one shaft lumen (<NUM>);
wherein when the shaft (<NUM>) is operably joined to the outer sheath (<NUM>), at least a portion of the at least one shaft side wall opening (<NUM>) is selectively aligned with a respective outer sheath side wall opening (<NUM>).