Patent Description:
Delivery systems for implanting intraluminal medical devices at a point of treatment within a body vessel require both pushability and flexibility. Development of delivery systems and delivery system components that provide these desirable characteristics continues. <CIT> describes a delivery system for an intraluminal medical device that comprises an elongate tubular sheath and an elongate tubular pusher slidably disposed within a lumen of the sheath and having a flexible configuration due to circumferentially-extending fins along its exterior surface. The spacing and/or the size of the fins may vary along the pusher. Different regions of the pusher may be of materials with different flexibility. <CIT> describes an elongate tubular shaft for use in catheter assemblies. The shaft is a metallic hypotube having a plurality of cuts in the side wall thereof to define slots. The slots are elongate slots extending about the wall of the hypotube in a substantially spiral or circumferential path which is interrupted at intervals by solid struts. <CIT> describes a component for use as or incorporation within a medical instrument navigable through body vessels of a human subject. The component includes a tubular portion with an interrupted spiral defined by alternating cut and uncut sections. The interrupted spiral has a rigidity between that of a continuous cut spiral and an uncut tube. The rigidity of the interrupted spiral along its length may be varied by changing its pitch or the number of bridge members or the length of each bridge member. <CIT> describes a flexible inner member for being rotatably disposed in an angled outer tubular member of a rotary tissue cutting instrument. <CIT> describes a bend relief for supporting a cannula. <CIT> describes a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. <CIT> describes a slitted pipe that includes a first slit pattern helically extending in a longitudinal direction of the slitted pipe and divided by girders into a plurality of slits at predetermined intervals, and a second slit pattern extending in the longitudinal direction to be helical in a direction opposite from a helical direction of the first slit pattern, and disposed at an angle to the first slit pattern to cross the girders.

Aspects of the invention are set out in the independent claims and optional features are set out in the dependent claims. Several cannulae are described and illustrated herein. An example cannula comprises an elongate tubular member having a circumferential wall extending between a proximal end and a distal end and defining an interior lumen; a pattern of openings extends along a portion of the axial length of the cannula.

Another example cannula comprises an elongate tubular member having a circumferential wall extending between a proximal end and a distal end and defining an interior lumen; a pattern of openings extends along the entire axial length of the cannula.

Another example cannula comprises an elongate tubular member having a circumferential wall extending between a proximal end and a distal end and defining an interior lumen; a pattern of openings extends along an intermediate portion of the axial length of the cannula that is disposed between proximal and distal portions of the cannula that are free of the pattern of openings.

Another example cannula comprises an elongate tubular member having a circumferential wall extending between a proximal end and a distal end and defining an interior lumen; a pattern of openings extends along an intermediate portion of the axial length of the cannula that is disposed between proximal and distal portions of the cannula that are free of the pattern of openings; the proximal portion is longer than the distal portion.

Several delivery systems are described and illustrated herein.

Several methods of making a cannula are described and illustrated herein. An example method of making a cannula comprises identifying a cannula material and a cannula wall thickness that provides a desired global stiffness for said cannula; identifying one or more axial lengths of said cannula along which a localized stiffness, different from the desired global stiffness, is desired; identifying a pattern of openings that will provide the desired localized stiffness when cut into a cannula formed of the cannula material and having the cannula wall thickness; and cutting the pattern of openings into a cannula formed of the cannula material and having the cannula wall thickness at axial positions that correspond to the one or more axial lengths.

Several methods of making a delivery system are described and illustrated herein. An example method of making a delivery system comprises identifying a cannula material and a cannula wall thickness that provides a desired global stiffness for said cannula; identifying one or more axial lengths of said cannula along which a localized stiffness, different from the desired global stiffness, is desired; identifying a pattern of openings that will provide the desired localized stiffness when cut into a cannula formed of the cannula material and having the cannula wall thickness; cutting the pattern of openings into a cannula formed of the cannula material and having the cannula wall thickness at axial positions that correspond to the one or more axial lengths; disposing an intraluminal medical device on a portion of the cannula that is free of the pattern of openings; and inserting the cannula into an elongate tubular member defining a lumen such that the intraluminal medical device is circumferentially disposed about the cannula and within the lumen.

Additional understanding of the inventive cannulae, delivery systems and methods can be obtained by reviewing the description of selected examples, below, with reference to the appended drawings.

The following detailed description and appended drawings describe and illustrate various examples contemplated by the inventors. The description and drawings serve to enable one skilled in the art to make and use the inventive cannulae and delivery systems, and to practice the inventive methods; they are not intended to limit the scope of the invention or the protection sought in any manner. The invention is capable of being practiced or carried out in various ways; the examples described herein are merely selected examples of these various ways and are not exhaustive. As such, the language used in the description is to be given the broadest possible scope and meaning.

Unless otherwise defined herein, scientific and technical terms used in connection with the invention shall have the meanings that are commonly understood by those of ordinary skill in the art.

As used herein, the term "opening" refers to a passage defined by a member between opposing or substantially opposing surfaces of the member. The term does not require any particular configuration of the passage. Indeed, the term includes rectangular passages, generally rectangular passages, square passages, generally square passages, circular passages, generally circular passages, triangular passages, generally triangular passages, and irregular passages.

As used herein, the term "slit" refers to an opening that has a rectangular or generally rectangular shape when the surfaces between which the passage extends lie on parallel planes.

<FIG> illustrate a first example cannula <NUM>. The cannula <NUM> is an elongate tubular member having a circumferential wall <NUM> extending between a proximal end <NUM> and a distal end <NUM>. The circumferential wall <NUM> defines an interior lumen <NUM>. A proximal opening <NUM> on the proximal end <NUM> provides access to the interior lumen <NUM>. Similarly, a distal opening <NUM> on the distal end <NUM> provides access to the interior lumen <NUM>. A longitudinal axis <NUM> extends centrally through the lumen. As best illustrated in <FIG>, each of a plurality of transverse axes, such as transverse axis <NUM>, lies on an individual plane that orthogonally intersects the longitudinal axis <NUM> at a point along its length.

A pattern of openings <NUM> extends along a portion of the axial length of the cannula <NUM>. In the illustrated example, the pattern of openings <NUM> extends along the entire axial length of the cannula <NUM>, extending between the proximal <NUM> and distal <NUM> ends. The pattern of openings <NUM> can extend along any suitable portion of the axial length of the cannula <NUM>, though, and the entire axial length, as in the illustrated cannula <NUM>, is only an example. For a cannula according to a particular example, a skilled artisan will be able to select a suitable portion of the axial length of the cannula along which the pattern of openings is to extend based on various considerations, including any need or desire for axial portions having a greater stiffness than that provided by an axial portion along which the pattern of openings extends. For example, if it is desirable to have an axial portion that has the global stiffness of the cannula material itself, the cannula can be made so that the pattern of openings does not extend along the axial portion for which the global stiffness is desired. Each of <FIG>, <FIG>, described in detail below, illustrates an example cannula in which the pattern of openings does not extend along the entire axial length of the cannula.

As best illustrated in <FIG>, the pattern of openings <NUM> comprises a plurality of openings <NUM> arranged in an interrupted spiral <NUM> that extends circumferentially along the circumferential wall <NUM> of the cannula <NUM>. In the illustrated embodiment, each opening <NUM> of the plurality of openings <NUM> comprises a slit that extends through the entire wall thickness of the circumferential wall <NUM> to provide access to the lumen <NUM> of the cannula <NUM>. The slit of each opening has a generally rectangular shape having a major axis m disposed on a plane that is transverse to the longitudinal axis <NUM> of the cannula <NUM>. One end <NUM> of the slit of each opening <NUM> has a slightly enlarged width, measured along the minor axis of the oblong rectangle of the slit. This enlarged width can be an artifact of some techniques used for forming the openings <NUM> in the circumferential wall <NUM> of the cannula <NUM>, such as laser cutting. Inclusion of the enlarged width, accordingly, is considered optional. The overall pattern of openings <NUM> takes a spiral <NUM> configuration relative to the longitudinal axis of the cannula <NUM> because the major axis m of each opening is disposed on a plane that intersects the longitudinal axis <NUM> of the cannula <NUM> at a non-orthogonal angle a. Thus opening <NUM> in <FIG>, which is illustrated relative to longitudinal axis <NUM> and transverse axis <NUM> of cannula <NUM>, is slightly skewed relative to transverse axis <NUM>, as are all other openings <NUM> in the plurality of openings <NUM>.

The inventors have determined that various parameters of the pattern of openings <NUM> can be manipulated to achieve a desired stiffness in the cannula <NUM> along an axial portion of the cannula <NUM>. For example, the distance between revolutions of the spiral, illustrated in <FIG> as the gap <NUM> between openings <NUM> in immediately adjacent revolutions of the spiral, can be increased or decreased to achieve a desired number of revolutions of the spiral per unit of length of the cannula <NUM>, which, in turn, increases or decreases, respectively, the stiffness of the cannula along the axial portion containing the pattern of openings <NUM>. Stated differently, the pitch of the spiral path along which the openings extend on the cannula can be increased or decreased to achieve a desired stiffness along the axial portion containing the pattern of openings <NUM>. Also, the distance between openings within a revolution of the spiral, illustrated in <FIG> as the gap <NUM> between openings, can be increased or decreased to achieve a desired number of openings in a revolution of the spiral. The major length <NUM> of the oblong rectangle formed by the openings <NUM> can be varied as well. Also, the ratio of the major length <NUM> of the oblong rectangle of the opening to the distance between openings within a revolution of the spiral, i.e., gap <NUM>, can be increased or decreased to achieve a desired number of openings in a revolution of the spiral, which, in turn, increases or decreases, respectively, the stiffness of the cannula along the axial portion containing the pattern of openings <NUM>. The angle a at which a plane containing the major axis m of individual openings <NUM> intersects the longitudinal axis <NUM> of the cannula <NUM> can also be increased or decreased to achieve a desired flexibility.

A skilled artisan will be able to manipulate one or more of these parameters in a cannula according to a particular embodiment to achieve a desired flexibility along the axial portion containing a pattern of openings. Surprisingly, the inventors have determined that a cannula made in this manner retains enough stiffness to effectively serve as the innermost member of a delivery system useful for placing an intraluminal medical device at a point of treatment within a body vessel. While providing a desired degree of local flexibility through manipulation of the parameters described above, such a cannula is able to carry the intraluminal medical device of the delivery system, such as a stent, valve, filter or other expandable intraluminal medical device, and, effectively, serve as a pusher that provides the pushability and/or trackability needed for navigation of the delivery system to an intraluminal point of treatment.

Indeed, while the openings <NUM> in the illustrated embodiment comprise slits, any suitable opening can be used in a cannula according to a particular embodiment, including openings that provide rectangular passages, openings that provide generally rectangular passages, openings that provide square passages, openings that provide generally square passages, openings that provide circular passages, openings that provide generally circular passages, openings that provide triangular passages, openings that provide generally triangular passages, and openings that provide irregular passages. The inventors have determined, though, that slits are particularly advantageous at least because of the relative ease with which they can be formed in an elongate tubular member and the ease with which they can be aligned along a spiral path on an elongate tubular member.

Each of <FIG> illustrates an alternative cannula with wall openings arranged in an alternative pattern achieved by manipulating one or more of the parameters described above. In the cannula <NUM>' illustrated in <FIG>, the gap <NUM>' between openings <NUM>' in immediately adjacent revolutions of the spiral is larger than the gap <NUM> used in cannula <NUM> illustrated in <FIG>.

The gap between openings in immediately adjacent revolutions of the spiral in a cannula according to a particular embodiment can have any suitable length as measured along the longitudinal axis of the cannula. A skilled artisan will be able to select an appropriate length for this gap for a particular cannula according to various considerations, including the nature of the material from which the cannula is formed and any desired flexibility in the axial length of the cannula along which the pattern of openings that contains the gaps extends. The inventors have determined that a gap the is between about <NUM> and about <NUM> times the axial width of the openings in the pattern of openings is suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider a gap that is between about <NUM> and about <NUM> times the axial width of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider a gap that is between about <NUM> and about <NUM> times the axial width of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider a gap that is about <NUM> times the axial width of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein.

In the cannula <NUM>" illustrated in <FIG>, the gap <NUM>" between openings <NUM>" within a revolution of the spiral is larger than the gap <NUM> used in cannula <NUM> illustrated in <FIG>.

The gap between openings within a revolution of the spiral in a cannula according to a particular embodiment can have any suitable length as measured along the major axis of the openings of revolution. A skilled artisan will be able to select an appropriate length for this gap for a particular cannula according to various considerations, including the nature of the material from which the cannula is formed and any desired flexibility in the axial length of the cannula along which the pattern of openings that contains the gaps extends. The inventors have determined that a gap that is between about <NUM> and about <NUM> times the axial length of the openings in the pattern of openings is suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors consider a gap that is between about <NUM> and about <NUM> times the axial length of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider a gap that is between about <NUM> and about <NUM> times the axial length of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider a gap that is about <NUM> times the axial length of the openings in the pattern of openings to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein.

In the cannula <NUM>‴ illustrated in <FIG>, the angle a‴ at which each of the planes containing a major axis of an opening <NUM>‴ intersects the longitudinal axis <NUM>‴ of the cannula <NUM>‴ is smaller, or more acute, than the angle a used in cannula <NUM> illustrated in <FIG>.

The angle at which each of the planes containing a major axis of an opening intersects the longitudinal axis of a cannula according to a particular embodiment can have any suitable measure. A skilled artisan will be able to select an appropriate measure for this angle for a particular cannula according to various considerations, including the nature of the material from which the cannula is formed and any desired flexibility in the axial length of the cannula along which the pattern of openings that contains the angle extends. The inventors have determined that an angle that is between about <NUM> degrees and about <NUM> degrees is suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors consider an angle that is between about <NUM> degrees and about <NUM> degrees to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider an angle that is between about <NUM> degrees and about <NUM> degrees to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. The inventors also consider an angle that is about <NUM> degrees to be suitable for a cannula intended to be used in an intraluminal medical device delivery system as described herein. Also, it is noted that the angle can be disposed in either direction relative to the cannula. As a result, the openings in the pattern of openings in a cannula according to a particular embodiment can extend toward the proximal end of the cannula or toward the distal end of the cannula.

In the first example cannula <NUM>, the pattern of openings <NUM> is uniform in that the various parameters described above - the distance between revolutions of the spiral, i.e., gap <NUM> and, therefore, the pitch of the spiral path along which the openings <NUM> extend, the distance between openings within a revolution of the spiral, i.e., gap <NUM>, the major length <NUM> of the oblong rectangle formed by the openings <NUM>, the ratio of the major length <NUM> of the oblong rectangle of the openings <NUM> to the distance between openings within a revolution of the spiral, i.e., gap <NUM>, of the openings <NUM> - are uniform throughout the pattern of openings <NUM>. That is, the each of the parameters has a substantially constant value that does not vary within the axial portion of the cannula along which the pattern of openings <NUM> extends. For some cannula, though, it may be desirable to have one or more of these parameters vary within the axial portion of the cannula along which the pattern of openings <NUM> extends.

<FIG> illustrates an example cannula <NUM> in which some of these parameters vary within the axial portion of the cannula <NUM> along which the pattern of openings <NUM> extends. For example, an intermediate portion 224a of the pattern of openings includes a first distance between revolutions of the spiral, i.e., gap 236a, and a first distance between openings within a revolution of the spiral, i.e., gap 238a. A proximal portion 224b of the pattern of openings includes a second distance between revolutions of the spiral, i.e., gap 236b, and a second distance between openings within a revolution of the spiral, i.e., gap 238b. Gap 236b is shorter in length that gap 236a. Similarly, gap 238b is shorter in length that gap 238a. A distal portion 224c of the cannula <NUM> is free of the pattern of openings <NUM>. This construction, where one or more of the parameters described above is varied within a single plurality of openings along an axial portion of a cannula, can be advantageously used in a cannula according to a particular example to provide a stiffness transition between an axial portion of relatively low stiffness, such as proximal portion 224b in cannula <NUM>, to an axial portion of the cannula of relatively high stiffness, such as distal portion 224c of cannula <NUM>, along which the pattern of openings <NUM> does not extend.

While the pattern of openings can extend along the entire axial length of a cannula, such as in the first example cannula <NUM>, a pattern of openings can extend along any suitable axial length of a cannula according to a particular embodiment. A skilled artisan will be able to select an appropriate axial length for a pattern of openings in a cannula according to a particular embodiment based on various considerations, including whether it is desirable to include any axial portions of the cannula that have a localized stiffness that is greater than the stiffness of the axial portions along which the pattern of openings extends. Each of <FIG> illustrates a cannula having a pattern of openings that extends along only a portion, or portions, of the entire axial length of the example cannula.

The cannula <NUM> illustrated in <FIG> has a pattern of openings <NUM> that extends along an intermediate portion <NUM> of the axial length of the cannula <NUM>. The pattern of openings <NUM> can be any suitable pattern of openings according to an embodiment, including those described above. The intermediate portion <NUM> extends between a proximal portion <NUM> and a distal portion <NUM>, each of which is free of the pattern of openings <NUM> and, indeed, comprises a solid, non-interrupted circumferential wall. This structural configuration is considered advantageous at least because it provides a relatively stiff distal portion <NUM> that is suitable for carrying an intraluminal medical device when the cannula <NUM> is included as a component in a delivery system, such as those described below. Furthermore, this configuration provides a relatively stiff proximal portion <NUM> that facilitates manipulation of the cannula <NUM>, or a delivery system that includes the cannula, by a user.

Each of the intermediate <NUM>, proximal <NUM> and distal <NUM> portions can extend along any suitable axial length of the cannula <NUM>, and a skilled artisan will be able to determine suitable axial lengths for each portion in a particular cannula based on various considerations, including the axial length of any intraluminal medical device with which the cannula is intended to be used. Furthermore, the portions can have any suitable relative axial lengths. For example, in the illustrated embodiment, the proximal portion <NUM> is longer than the distal portion <NUM>. It is noted, though, that an opposite relationship could be used, i.e., the distal portion of a cannula can have a longer axial length than a proximal portion.

The cannula <NUM> illustrated in <FIG> has a pattern of openings <NUM> that extends along a distal portion <NUM> of the axial length of the cannula <NUM>. The pattern of openings <NUM> can be any suitable pattern of openings according to an embodiment, including those described above. The distal portion <NUM> incudes the distal end <NUM> of the cannula <NUM>. A proximal portion <NUM> is free of the pattern of openings <NUM> and, indeed, comprises a solid, non-interrupted circumferential wall. This structural configuration is considered advantageous at least because it provides a relatively flexible distal portion <NUM> that is suitable for carrying some intraluminal medical devices through tortuous anatomy, such as neurovascular stents. Furthermore, this configuration provides a relatively stiff proximal portion <NUM> that facilitates manipulation of the cannula <NUM>, or a delivery system that includes the cannula, by a user.

Each of the proximal <NUM> and distal <NUM> portions can extend along any suitable axial length of the cannula <NUM>, and a skilled artisan will be able to determine suitable axial lengths for each portion in a particular cannula based on various considerations, including the axial length of any intraluminal medical device with which the cannula is intended to be used. Furthermore, the portions can have any suitable relative axial lengths. For example, in the illustrated embodiment, the proximal portion <NUM> is shorter than the distal portion <NUM>. It is noted, though, that an opposite relationship could be used, i.e., the distal portion of a cannula can have a longer axial length than a proximal portion.

The cannula <NUM> illustrated in <FIG> has a pattern of openings <NUM> that comprises distinct sections 510a, 510b, and 510c that are separated from each other by intervening sections <NUM>, <NUM>. The cannula <NUM> also includes a proximal portion <NUM> and a distal portion <NUM>, each of which is free of the pattern of openings <NUM> and, indeed, comprises a solid, non-interrupted circumferential wall. In each of the distinct sections 510a, 510b, 510c, the pattern of openings <NUM> can be any suitable pattern of openings according to an embodiment, including those described above. Furthermore, the pattern of openings in each of the distinct sections 510a, 510b, 510c can be the same pattern as in the other distinct sections 510a, 510b, 510c. Alternatively, the pattern of openings in each of the distinct sections 510a, 510b, 510c can be different from the pattern of openings in one or two of the other distinct sections 510a, 510b, 510c. Also, each of the distinct sections 510a, 510b, 510c can have any suitable axial length along the cannula <NUM>. In the illustrated embodiment, each of the distinct sections 510a, 510b, 510c extends along an axial length of the cannula <NUM> that is the same as the axial length along which the other of the distinct sections 510a, 510b, 510c extends along. It is noted, though, that each of the distinct sections 510a, 510b, 510c can extend along an axial length that id different from the axial length along which one or more of the other distinct sections 510a, 510b, 510c extends along. Also, in any given embodiment, any suitable number of distinct sections can be used.

In some embodiments, one or more openings in the pattern of openings that are positioned at specific locations on the cannula are arranged relative to other openings in the pattern of openings such that these openings vary from the interrupted spiral that extends circumferentially along the circumferential wall of the cannula. This structural configuration can be used to provide desired structural characteristics, such as preferential bending and resistance to bending, at distinct locations within the pattern of openings and, indeed, on the cannula itself. This structural arrangement can provide particular desirable characteristics when a particular lengthwise axis that lies on the circumferential surface of a cannula is designated as the specific location for openings that vary from the interrupted spiral that extends along the circumferential wall of the cannula.

<FIG> illustrate an example cannula <NUM> in which all openings that intersect a particular lengthwise axis <NUM> that lies on the circumferential surface <NUM> of the cannula <NUM> are disposed at an angle relative to the central longitudinal axis <NUM> of the cannula <NUM> that is different than the angle at which openings that do not intersect lengthwise axis <NUM> are disposed relative to the central longitudinal axis <NUM> of the cannula <NUM>. Thus, as best illustrated in <FIG>, cannula <NUM> has a pattern of openings <NUM> that includes a first set of openings <NUM> that are disposed on planes <NUM>, <NUM> that intersect the central longitudinal axis <NUM> at a first angle a<NUM> and a second set of openings <NUM> that are disposed on planes, such as plane <NUM>, that intersect the central longitudinal axis <NUM> at a second angle a<NUM>. Circumferentially, as best illustrated in <FIG>, each of the openings in the second set of openings <NUM> intersects the particular lengthwise axis <NUM> and, therefore, intersects a particular circumferential point <NUM>.

In these embodiments, the first a<NUM> and second a<NUM> angles can differ by any suitable amount, and a skilled artisan will be able to select a suitable difference between the angles in a cannula according to a particular embodiment based on various considerations, including any desired degree of stiffness balances against any desired structural characteristic provided by the use of first and second angles, such as preferential bending. Furthermore, both angles can be acute or obtuse, or one angle can be acute and another can be obtuse. The illustrated embodiment, in which both the first a<NUM> and second a<NUM> angles are acute but first a<NUM> angle is greater than the second a<NUM> angle, is one example structural arrangement of many that can be used.

It is noted that, while alternate angles relative to the central longitudinal axis <NUM> have been described and illustrated, other structural characteristics of the openings that intersect a particular lengthwise axis can differ from other openings in a particular cannula to achieve a desired overall structural characteristics for the cannula. For example, the length, width and even shape and configuration of the intersecting openings can be altered to suitable parameters to achieve a desired characteristic.

Providing different structural characteristics for openings that intersect a particular longitudinal axis of a cannula, as described above, can provide particularly desirable performance characteristics for a cannula when the axis of intersection lies along a seam in a cannula roll-formed from an initially flat ribbon and joined to form a tube, such as by welding along the seam. <FIG> illustrate example cannulae <NUM>, <NUM>, <NUM> formed in this manner.

In <FIG>, cannula <NUM> has a pattern of openings <NUM> that includes a first set of openings <NUM> that are disposed on planes, such as planes <NUM>, <NUM>, that intersect the central longitudinal axis <NUM> at a first angle a<NUM> and a second set of openings <NUM> that are disposed on planes, such as plane <NUM>, that intersect the central longitudinal axis <NUM> at a second angle a<NUM> that is different than the first angle a<NUM>. Each opening in the second set of openings <NUM> intersects a longitudinal axis <NUM> that lies along a longitudinal seam <NUM> in the cannula <NUM>.

In <FIG>, cannula <NUM> has a pattern of openings <NUM> that includes a first set of openings <NUM> and a second set of openings <NUM>. Each opening in the second set of openings <NUM> intersects a longitudinal axis <NUM> that lies along a longitudinal seam <NUM> in the cannula <NUM>. In this embodiment, each opening in the second set of openings <NUM> has a larger width and length than that of each opening in the first set of openings <NUM>. Thus, each opening of the second set of openings <NUM> has a greater total open area than each opening in the first set of openings <NUM>.

In <FIG>, cannula <NUM> has a pattern of openings <NUM> that only includes a first set of openings <NUM>. There are no openings in the pattern of openings <NUM> that intersect a longitudinal axis <NUM> that lies along a longitudinal seam <NUM> in the cannula <NUM>. Any opening that would intersect the longitudinal axis <NUM> and longitudinal seam <NUM> due to the regular pattern of the pattern of openings <NUM> extending along a spiral path on the circumferential surface <NUM> of the cannula has been omitted from the pattern of openings and never formed in the cannula. This structural arrangement may be beneficial in cannulae in which a greater degree of stiffness is desired along a particular lengthwise axis, such as one that lies along a lengthwise seam.

Inclusion of a second pattern of openings within a first pattern of openings can also provide desirable performance characteristics for a cannula. Thus, a cannula can include a second pattern of openings that extends along any suitable axial portion of the axial length along which the first pattern of openings extends. In these embodiments, the second pattern of openings can have the same or different structural properties of the first pattern of openings. For example, the second pattern of openings can have openings of the same size, shape and configuration as those of the first pattern of openings and the second pattern of openings can extend along a spiral path on the cannula having the same pitch as that along which the first pattern of openings extends. Alternatively, the second pattern of openings can have openings having different structural properties of those of the first pattern of openings and/or the openings of the second pattern of openings can extend along a spiral path on the cannula that has a different pitch than that along which the first pattern of openings extends.

<FIG> illustrates an example cannula <NUM> having first <NUM> and second <NUM> patterns of openings. The second pattern of openings <NUM> extends along an axial portion <NUM> of the axial length <NUM> along which the first pattern of openings <NUM> extends. In the illustrated embodiment, the axial portion <NUM> is located within the axial length <NUM> such that the axial length <NUM> includes proximal <NUM> and distal <NUM> regions that extend beyond the axial portion <NUM>. Also, cannula <NUM> includes proximal <NUM> and distal <NUM> axial portions that are free of both patterns of openings <NUM>, <NUM>. In the illustrated embodiment, the second pattern of openings <NUM> extends along a spiral path on the circumference of the cannula that has a different pitch, a greater pitch, than the pitch of the spiral path along which the first pattern of openings <NUM> extends. As noted above, the first <NUM> and second <NUM> pattern of openings can extend along spiral paths having different pitches, as illustrated, or the same pitches. Also, the openings in the first second <NUM> patterns of openings in the illustrated embodiment are longer and wider than the openings in the first pattern of openings. As noted above, the openings of the first <NUM> and second <NUM> patterns of openings can have different structural characteristics, as illustrated, or can have identical or substantially identical structural characteristics.

A cannula can include one or more additional components. For example, to achieve desired structural and/or performance characteristics for a cannula, an inner member, such as a polymeric shaft or wire member, can be disposed within the lumen defined by a cannula. An outer member, such as an outer sheath or coating, can be disposed circumferentially about a cannula.

<FIG> illustrate an example cannula <NUM> around which an outer sheath <NUM> has been disposed. In the illustrated embodiment, the outer sheath <NUM> comprises a length of tubing that has been disposed circumferentially about the elongate member of the cannula <NUM> and shrunk down onto the circumferential surface of the cannula, such as by exposure to heat. Inclusion of an outer sheath in this manner can be advantageous when certain properties are desired for the cannula. For example, the inclusion of an outer Teflon or polyurethane sheath can provide lubriciousness for the cannula, which may be desirable when the cannula is intended to be used as an outer member in a delivery system or on its own.

In these embodiments, the openings of the pattern of openings can be covered by the outer sheath. Alternatively, the outer sheath can be disrupted to provide access to one, at least one, some, a plurality of, or all of the openings of the pattern of openings. This may be desirable when fluid access between the lumen of the cannula and the external environment is desired, such as when fluid flushing from the lumen to the external environment, or vice versa, is desired. In the illustrated embodiment, a first set of openings <NUM> of the pattern of openings remain covered by the outer sheath <NUM> while the outer sheath <NUM> includes disruptions <NUM> that provide access to a second set <NUM> of openings of the pattern of openings <NUM>. In this embodiment, each opening of the second set of openings <NUM> intersects a longitudinal seam <NUM> of the cannula <NUM>, which lies on a longitudinal axis <NUM> on the circumferential surface <NUM> of the cannula <NUM>. The disruptions <NUM> in the outer sheath <NUM> provide access to the lumen <NUM> defined by the cannula <NUM>. Thus, as best illustrated in <FIG>, the disruptions <NUM> and the points at which fluid access to the lumen <NUM> exists, have a known circumferential position on the cannula <NUM> - the longitudinal seam <NUM>.

As an alternative to disrupting an outer sheath to provide fluid communication between the lumen defined by the cannula and the external environment, multiple outer sheaths can be disposed circumferentially about the cannula such that they are axially spaced from each other along the length of the cannula, leaving an axial gap between them. By positioning the axial gap or gaps at axial locations that include openings in a pattern of openings disposed on the cannula, the desired fluid communication is established even though the outer sheaths are not disrupted and the openings they extend over are, effectively, blocked.

A cannula according to an example can be made of any suitable material. A skilled artisan will be able to select an appropriate material for a cannula according to a particular example based on various considerations, including any desired overall stiffness and/or flexibility of the cannula and the point of treatment at which the cannula is intended to be used. Metals are considered advantageous for the examples described and illustrated herein, but polymeric, including plastic materials currently considered suitable for use in medical devices, and other materials can be used. Stainless steel is considered particularly advantageous for the example cannulae described and illustrated herein at least because of its well-characterized nature, acceptance as a material used in medical devices temporarily placed within body lumens, and ready availability. Examples of other metals considered suitable for use in cannulae according to particular examples include cobalt-chrome and shape memory alloys, such as nickel-titanium alloys. Examples of polymeric materials considered suitable for use in cannulae according to particular examples include polyamide materials, such as nylon, and other polymeric materials. A cannula can include multiple materials, too, if desired. For example, an axial length of one material can be joined to an axial length of another material to create a cannula. The pattern of openings in such a cannula can be disposed on any suitable axial portion of the cannula, such as an axial portion comprising only the first material, an axial portion comprising only the second material, or an axial portion comprising both the first and the second material.

It is noted that a cannula according to a particular example can have a lumen of any suitable diameter and that the dimensions of the lumen of the cannulae described and illustrated herein are illustrative only. A skilled artisan will be able to select an appropriate lumen size for a cannula according to a particular example based on various considerations, including the dimensions of the lumen of the body vessel within which the cannula and/or delivery system is intended to be used.

It is noted that a cannula according to a particular example can have a circumferential wall of any suitable wall thickness and that the wall thicknesses of the circumferential wall of the cannulae described and illustrated herein are illustrative only. A skilled artisan will be able to select an appropriate wall thickness for a cannula according to a particular embodiment based on various considerations, including any desired overall stiffness of the cannula. Indeed, the inventors have determined that a wall thickness can be selected when making a cannula according to a particular example that provides a desired stiffness to any axial portions of the cannula not having a pattern of openings disposed on the portion of the circumferential wall within that particular axial portion. As described in detail below, combining a selected wall thickness with one or more selected patterns of openings along the axial length of a cannula allows a user to make a cannula with desired global and local stiffnesses.

The cannulae can be used as a component of a delivery system useful for delivering an intraluminal medical device to a point of treatment within a lumen of a body vessel. Indeed, structural characteristics of the cannulae make the cannulae useful as various components of a delivery system. For example, the cannulae can be used as an inner core member in a delivery system, as a pusher in a delivery system, and/or as an outer tubular member of a delivery system. When used as one or more of these components in a delivery system, the desirable stiffness properties of the cannulae provide delivery systems that are particularly well suited for delivering a variety of intraluminal medical devices to points of treatment within various body vessels. For example, delivery systems that include example cannulae are expected to be well-suited for delivery of prosthetic venous valves, stents, filters, occluders, neurovascular stents and other intraluminal medical devices.

Inclusion of a cannula as an inner core member in a delivery system may be advantageous where an intended point of treatment and/or navigation route makes localized flexibility desirable. In these embodiments, an intraluminal medical device can be disposed circumferentially about, and carried by, the cannula, which is then surrounded by an outer elongate tubular member, such as a conventional delivery system sheath.

<FIG> illustrates a first example delivery system <NUM> in which a cannula according to an embodiment is included as an inner core member. The delivery system <NUM> includes a cannula <NUM> according to an embodiment disposed within the lumen <NUM> defined by an outer tubular member <NUM>. An intraluminal medical device <NUM> is circumferentially disposed around the cannula <NUM> and within the lumen <NUM> of the outer tubular member <NUM>.

The cannula <NUM> can comprise any suitable cannula according to an embodiment and a skilled artisan will be able to select a suitable cannula for inclusion in a particular delivery system based on various considerations, including the nature, size and configuration of the intraluminal medical device <NUM> and any desired local and/or global flexibility and/or stiffness properties for the delivery system <NUM>. In the illustrated delivery system <NUM>, a cannula <NUM> having a pattern of openings <NUM> that extends along the entire axial length of the cannula <NUM> is included in the delivery system <NUM>. This is considered particularly advantageous for delivery systems for which overall flexibility is the primary desired characteristic.

The intraluminal medical device <NUM> can comprise any suitable intraluminal medical device. The delivery systems are particularly well-suited, however, for use with self-expandable medical devices, including stents, valves, such as venous valve and cardiac valves, filters, occluders, and other intraluminal medical devices.

Additional components can be attached to the cannula <NUM> using conventional approaches. For example, in the illustrated embodiment, a conical distal tip <NUM> has been disposed on and secured to the distal end of the cannula <NUM>. Similarly, additional components can be attached to the elongate tubular member <NUM> using conventional approaches. For example, in the illustrated embodiment, a hub <NUM> providing a side-arm connector <NUM> is disposed on and secured to the proximal end of the elongate tubular member <NUM>.

It is noted that the cannula <NUM> provides desirable flexibility and pushability characteristics for the delivery system <NUM> such that additional components, such as a pusher, are not required for its use. Thus, the delivery system can consist only of a cannula according to an embodiment, such as cannula <NUM>, an elongate tubular member <NUM>, and an intraluminal medical device <NUM>. If desired or necessary, the delivery system <NUM> can be advanced over a previously-placed wireguide (not shown) for conventional navigation purposes.

<FIG> illustrates a second example delivery system <NUM> in which a cannula according to an embodiment is included as an inner core member. Delivery system <NUM> is similar to delivery system <NUM> described above and illustrated in <FIG>, except as detailed below. Thus, delivery system <NUM> includes a cannula <NUM> according to an embodiment disposed within the lumen <NUM> defined by an outer tubular member <NUM>. The delivery system illustrated in <FIG> does not fall within claim <NUM> or <NUM> because the intraluminal medical device <NUM> is circumferentially disposed around the cannula <NUM> and within the lumen <NUM> of the outer tubular member <NUM>. An elongate double-tapered distal tip <NUM> has been disposed on and secured to the distal end of the cannula <NUM>. A hub <NUM> providing a side-ann connector <NUM> is disposed on and secured to the proximal end of the elongate tubular member <NUM>.

The delivery system <NUM> also includes tubular pusher <NUM> that is slidably disposed over the cannula <NUM>. During use, the tubular pusher <NUM> can be axially advanced over the cannula <NUM> toward the intraluminal medical device <NUM> until the distal end <NUM> of the tubular pusher <NUM> abuts or otherwise engages the proximal end of the intraluminal medical device <NUM>. At that point, the tubular pusher <NUM> can continue to be distally advanced, thereby forcing distal advancement of the intraluminal medical device <NUM> until it exits the lumen <NUM> defined by the outer tubular member <NUM>. Alternatively, the outer tubular member <NUM> can be proximally withdrawn while the position of the tubular pusher <NUM> is maintained until the intraluminal medical device <NUM> exits the lumen <NUM> defined by the outer tubular member <NUM>.

The cannula <NUM> can comprise any suitable cannula according to an embodiment and a skilled artisan will be able to select a suitable cannula for inclusion in a particular delivery system based on various considerations, including the nature, size and configuration of the intraluminal medical device <NUM> and any desired local and/or global flexibility and/or stiffness properties for the delivery system <NUM>. In the illustrated embodiment, the cannula <NUM> is similar to the cannula <NUM> illustrated in <FIG>. Thus, the cannula <NUM> has a pattern of openings <NUM> that extends along an intermediate portion <NUM> of the axial length <NUM> of the cannula <NUM>. The pattern of openings <NUM> can be any suitable pattern of openings according to an embodiment, including those described above. The intermediate portion <NUM> extends between a proximal portion <NUM> and a distal portion <NUM>, each of which is free of the pattern of openings <NUM> and, indeed, comprises a solid, non-interrupted circumferential wall. This structural configuration is considered advantageous at least because it provides a relatively stiff distal portion <NUM> that is suitable for carrying the intraluminal medical device <NUM> and provides a relatively stiff proximal portion <NUM> that facilitates manipulation of the delivery system <NUM> during use. This arrangement is considered advantageous for use with low profile intraluminal medical devices, such as stents.

<FIG> illustrates an example delivery system <NUM> in which a cannula according to an embodiment is included as a pusher and, along with an intraluminal medical device, is disposed circumferentially about an inner member. In this embodiment, delivery system <NUM> includes a cannula <NUM> according to an embodiment disposed within the lumen <NUM> defined by an outer tubular member <NUM>. An intraluminal medical device <NUM> is circumferentially disposed within the lumen <NUM> of the outer tubular member <NUM> and distal to the cannula <NUM>. In this embodiment, the intraluminal medical device is not disposed about the cannula <NUM> in the fully assembled delivery system <NUM>. A hub <NUM> providing a side-arm connector <NUM> is disposed on and secured to the proximal end of the elongate tubular member <NUM>.

In this embodiment, the cannula <NUM> and intraluminal medical device <NUM> are each circumferentially disposed about an inner core member <NUM>, such as a solid core member, a lumen-defining member, or a wire. As such, the cannula <NUM> is positioned for use as a pusher on the intraluminal medical device <NUM>. Thus, during use, the cannula <NUM> can be axially advanced over the inner core member <NUM> toward the intraluminal medical device <NUM> until the distal end <NUM> of the cannula <NUM> abuts or otherwise engages the proximal end <NUM> of the intraluminal medical device <NUM>. At that point, the cannula <NUM> can continue to be distally advanced, thereby forcing distal advancement of the intraluminal medical device <NUM> until it exits the lumen <NUM> defined by the outer tubular member <NUM>. Alternatively, the outer tubular member <NUM> can be proximally withdrawn while the position of the cannula <NUM> is maintained until the intraluminal medical device <NUM> exits the lumen <NUM> defined by the outer tubular member <NUM>.

The cannula <NUM> can comprise any suitable cannula according to an embodiment and a skilled artisan will be able to select a suitable cannula for inclusion in a particular delivery system based on various considerations, including the nature, size and configuration of the intraluminal medical device <NUM> and any desired local and/or global flexibility and/or stiffness properties for the delivery system <NUM>. In the illustrated embodiment, the cannula <NUM> is similar to the cannula <NUM> illustrated in <FIG>. Thus, the cannula <NUM> has a first pattern of openings <NUM> that extends along a first axial length <NUM> of the cannula <NUM> and a second pattern of openings <NUM> that extends along a second axial length <NUM> of the cannula <NUM>. The second axial length <NUM> is a portion of the first axial length <NUM>, which provides an axial length <NUM> of the cannula <NUM> along which both the first <NUM> and second <NUM> pattern of openings extend. In the illustrated embodiment, the second pattern of openings <NUM> is a plurality of openings that extends linearly along only a single side of the intermediate axial portion of the cannula <NUM>. Also, the openings of the second pattern of openings <NUM> are interspersed with the openings of the first pattern of openings <NUM>. This structural configuration is considered advantageous at least because it provides a relatively stiff distal portion <NUM> that is suitable for contacting and pushing the intraluminal medical device <NUM> and provides an axial length <NUM> having enhanced flexibility.

<FIG> illustrates an example delivery system <NUM> in which a cannula <NUM> according to an embodiment is included as an outer tubular member that is disposed circumferentially about inner components of the delivery system. That is, an inner member, such as a dilator <NUM> on which an intraluminal medical device <NUM> is circumferentially disposed, is disposed within a lumen <NUM> defined by the cannula <NUM>. In this embodiment, the cannula <NUM> includes a full-length outer sheath <NUM> disposed over and secured to the cannula <NUM>. The cannula <NUM> includes a pattern of openings <NUM>. A first set of openings <NUM> of the pattern of openings <NUM> are covered by the outer sheath and a second set of openings <NUM> are adjacent disruptions <NUM> in the outer sheath <NUM> that establish communication between the external environment and the lumen <NUM> defined by the cannula <NUM>. This structural configuration is considered advantageous at least because it provides fluid communication channels that can be used for flushing the delivery system <NUM> before, during or after deployment of the intraluminal medical device <NUM> at a point of treatment.

<FIG> illustrates an example method <NUM> of making a cannula. A first step <NUM> comprises identifying a cannula material and a cannula wall thickness that provides a desired global stiffness for said cannula. Another step <NUM> comprises identifying one or more axial lengths of said cannula along which a localized stiffness, different from the desired global stiffness, is desired. Another step <NUM> comprises identifying a pattern of openings that will provide the desired localized stiffness when cut into a cannula formed of the cannula material and having the cannula wall thickness. Another step <NUM> comprises cutting the pattern of openings into a cannula formed of the cannula material and having the cannula wall thickness at axial positions that correspond to the one or more axial lengths.

<FIG> illustrates another example method <NUM> of making a cannula. A first step <NUM> comprises rolling a section of flat stock to form a slotted tube in which opposite sides of the flat stock are disposed opposite one another relative to a slot in the slotted tube. Another step <NUM> comprises securing the opposite sides to one another, to close, substantially close, or partially close the slot to form a cannula. Another step <NUM> comprises cutting a pattern of openings into the cannula.

The step <NUM> of rolling a sheet of flat stock can be performed in any suitable manner and using any suitable technique and/or equipment. The step <NUM> of securing the opposite sides to one another can be performed in any suitable manner and using any suitable technique and/or equipment. Welding the sides to each other and adhering the sides to each other are examples of suitable techniques that can be used. The step <NUM> of cutting a pattern of openings into the cannula can be performed in any suitable manner and using any suitable technique and/or equipment. Furthermore, any suitable pattern of openings can be made during performance of this step, including the various patterns of openings described and illustrated herein. In an alternative method an initial step of cutting a pattern of openings into the section of flat stock is included. In another alternative method, the step <NUM> of cutting a pattern of openings into the cannula is eliminated and an initial step of cutting a pattern of openings into the section of flat stock is included.

<FIG> is a schematic illustration of a transformation of matter that occurs with performance of steps of the method illustrated in <FIG>. A section of flat stock, such as ribbon <NUM>, is rolled to form slotted tube <NUM> having longitudinal slot <NUM>. A longitudinal weld join <NUM> is formed to close longitudinal slot and to form cannula <NUM>. A pattern of openings can then be cut into the cannula <NUM> using any suitable technique and/or process, such as laser cutting followed by post-processing to remove any slag created as a result of the cutting. Alternatively, a suitable laser capable of cutting the pattern of openings entirely by vaporization can be used to avoid the need for removal of slag in post-processing.

<FIG> illustrates an example method <NUM> of making a delivery system. A first step <NUM> comprises identifying a cannula material and a cannula wall thickness that provides a desired global stiffness for said cannula. Another step <NUM> comprises identifying one or more axial lengths of said cannula along which a localized stiffness, different from the desired global stiffness, is desired. Another step <NUM> comprises identifying a pattern of openings that will provide the desired localized stiffness when cut into a cannula formed of the cannula material and having the cannula wall thickness. Another step <NUM> comprises cutting the pattern of openings into a cannula formed of the cannula material and having the cannula wall thickness at axial positions that correspond to the one or more axial lengths. Another step <NUM> comprises disposing an intraluminal medical device on a portion of the cannula that is free of the pattern of openings. Another step <NUM> comprises inserting the cannula into an elongate tubular member defining a lumen such that the intraluminal medical device is circumferentially disposed about the cannula and within the lumen.

Claim 1:
A delivery system (<NUM>), comprising a cannula (<NUM>, <NUM>), comprising:
an elongate tubular member having a lengthwise axis and a circumferential wall extending between a proximal end and a distal end and defining an interior lumen (<NUM>);
the elongate tubular member having an intermediate axial portion (<NUM>) extending between a proximal axial portion (<NUM>) that includes the proximal end and a distal axial portion (<NUM>) that includes the distal end; and
a pattern of openings (<NUM>) in the circumferential wall of the elongate tubular member, the pattern of openings (<NUM>) comprising a plurality of openings arranged in an interrupted spiral that extends circumferentially along the intermediate axial portion (<NUM>) of the elongate tubular member; wherein the proximal axial portion (<NUM>) and the distal axial portion (<NUM>) are free of the pattern of openings and comprise an uninterrupted circumferential wall; and
wherein the proximal portion (<NUM>) is longer than the distal portion (<NUM>);
an elongate outer tubular member (<NUM>) defining an outer tubular member lumen; and
an intraluminal medical device (<NUM>) disposed within the outer tubular member lumen;
wherein the cannula (<NUM>) is disposed within the elongate outer tubular member lumen such that the cannula is disposed proximal to the intraluminal medical device and the intraluminal medical device (<NUM>) is not disposed about the cannula (<NUM>).