Introducer sheath

Abstract

An introducer sheath (10) including a sheath member (12) including an inner portion (22) defining a lumen (21) through which an endoluminal device may be moved and an outer portion (24) surrounding at least a portion of the inner portion, a first hub (14) coupled to the inner portion of the sheath member, and a second hub (16) coupled to the outer portion of the sheath member. When the first hub is actuated away from the second hub, a length of the sheath member positioned on the outer portion transitions from the outer portion to the inner portion.

Description

INTRODUCER SHEATHCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 597,916, filed November 10, 2023, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to apparatuses, systems, and methods for an introducer sheath for medical procedures. More specifically, the disclosure relates to apparatuses, systems, and methods for introducer sheaths that is configured to mitigate risk of trauma to tissues.BACKGROUND

[0003] Introducer sheaths and introducer sheath assemblies are used in a wide variety of minimally invasive and conventional surgical procedures, such as endoluminal delivery of surgical implements. Introducer sheaths typically include an introducer sheath and at least one valve for controlling leakage while introducing into the introducer sheath medical devices or surgical implements, such as endoprosthetic devices, dilators, guidewires and the like. Introducer sheaths can be sized such that trauma can occur to tissue as the introducer sheath is inserted into a patient’s anatomy. Additionally, during long procedures introducer sheaths may experience some adhesion to biological tissue, which can result in increased difficulty removing introducer sheaths at the end of the procedure. Additionally, there is possibility of some trauma to biological tissue when adhesion to the introducer sheath occurs. It remains desirable to provide introducer sheaths that are easier to remove and are configured to minimize trauma or tissue trauma during insertion and removal.SUMMARY

[0004] An introducer sheath is provided with configurations for mitigating trauma during insertion and during removal of the introducer sheath during procedures.

[0005] According to one example (“Example 1”), an introducer sheath is forintroducing a transcatheter component into a body of a patient, the introducer sheath being positioned at an access site such that a portion of the introducer sheath is in vivo and a portion of the introducer sheath is ex vivo during use, the introducer sheath includes a sheath member including an inner portion defining a lumen through which an endoluminal device or other surgical implement may be longitudinally moved and an outer portion surrounding at least a portion of the inner portion, a first hub coupled to the inner portion of the sheath member, and a second hub coupled to the outer portion of the sheath member, wherein, when the first hub is actuated away from the second hub, a length of the sheath member positioned on the outer portion transitions from the outer portion to the inner portion.

[0006] According to another example (“Example 2”), the introducer sheath of Example 1 , further includes a stiffener configured to be positioned between the inner portion and the outer portion of the sheath member.

[0007] According to another example (“Example 3”), further to Example 2, the stiffener is an elongate member defining a lumen and defining a slit along at least a portion of a longitudinal length of the stiffener.

[0008] According to another example (“Example 4”), further to Examples 2 and 3, the stiffener is relatively stiffer than the sheath member, wherein the sheath member has a material property of at least one of drapability, conformability, and low bending stiffness.

[0009] According to another example (“Example 5”), further to Examples 2-4, the sheath member is configured to accommodate a structure having a diameter greater than a diameter of the stiffener.

[0010] According to another example (“Example 6”), further to any of the preceding Examples, the sheath member is a film.

[0011] According to another example (“Example 7”), further to any of the preceding Examples, the introduced sheath assembly includes a dilator positioned in the lumen defined by the inner portion of the sheath member.

[0012] According to another example (“Example 8”), further to Example 7, the dilator includes a dilator tip and dilator body, wherein at least a portion of the dilator tip has a diameter that is larger than a diameter of the dilator body.

[0013] According to another example (“Example 9”), further to Example 8, at least a portion of the dilator tip is flush with the outer portion of the sheath member or has a diameter greater than the outer portion of the sheath member when the sheathmember is in a delivery configuration.

[0014] According to another example (“Example 10”), further to Examples 7-9, the dilator is removable from the lumen.

[0015] According to another example (“Example 11”), further to any of the preceding Examples, the introducer sheath assembly includes an introducer handle including a valve through which the sheath member extends.

[0016] According to another example (“Example 12”), further to Example 11 , the introducer handle includes a port through which the stiffener extends.

[0017] According to another example (“Example 13”), further to Example 12, an internal opening of the port is aligned to provide access to a space between the first hub and the second hub.

[0018] According to another example (“Example 14”), further to Example 1 , at least a portion of the inner portion of the sheath member is relatively stiffer than the outer portion of the sheath member.

[0019] According to another example (“Example 15”), further to Example 1 , at least a portion of the inner portion of the sheath member includes an integral stiffener.

[0020] According to another example (“Example 16”), further to Example 1 , at least a portion of the outer portion of the sheath member includes pores through which at least one of a fluid and a therapeutic is deliverable.

[0021] According to another example (“Example 17”), further to Example 2, the stiffener is tapered.

[0022] According to another example (“Example 18”), further to Example 1 , the introducer sheath assembly includes an endoluminal device positioned on a catheter and constrained by a constraining member to a delivery diameter, wherein the inner portion of the sheath member has a diameter that is greater than the delivery diameter of the endoluminal device such that the endoluminal device is longitudinally moveable through the sheath member.

[0023] According to an example (“Example 19”), a method of assembling an introducer sheath includes everting a sheath member such that the sheath member defines an inner portion defining a lumen through which an endoluminal device may be advanced and an outer portion surrounding at least a portion of the inner portion, wherein a first hub is coupled to the inner portion of the sheath member and a second hub is coupled to the outer portion of the sheath member, inserting astiffener between an inner portion and an outer portion of the sheath member, and inserting a dilator through the lumen.

[0024] According to another example (“Example 20”), the method includes coupling the first hub and the second hub together.

[0025] According to an example (“Example 21”), an introducer sheath assembly includes a sheath member operable to invert, the sheath member defining a lumen, the sheath member having a material property of at least one of drapability, conformability, and low bending stiffness; a stiffener removably positioned with and supporting the sheath member, the stiffener having a stiffness relatively higher than a stiffness of the sheath member; a dilator removably positioned in the lumen of the sheath member; and a hub coupled to the sheath member, wherein, when the hub is actuated, the hub is operable to cause inward eversion of at least a portion of the sheath member.

[0026] According to one example (“Example 22”), an introducer sheath assembly includes a sheath member operable to invert or evert, the sheath member defining a lumen, the sheath member having a material property of at least one of drapability, conformability, and low bending stiffness; and a stiffener configured to be removably engaged with and support the sheath member, the stiffener having a stiffness that is relatively greater than a stiffness of the sheath member.

[0027] According to another example (“Example 23”), further to Example 22, the sheath member includes an inner portion and an outer portion, wherein a space is defined between the inner portion and the outer portion, the space being configured to receive the stiffener therein.

[0028] According to another example (“Example 24”), further to Examples 21 or 22, the introducer sheath further includes a dilator removably positioned in the lumen of the sheath member; and a hub coupled to the sheath member, wherein, when the hub is actuated, the hub is operable to cause inward eversion of at least a portion of the sheath member.

[0029] According to one example (“Example 25”), an introducer sheath for introducing a transcatheter component into a body of a patient, the introducer sheath including a sheath member including an inner portion defining a lumen through which an endoluminal device may be longitudinally extended therethrough and an outer portion surrounding at least a portion of the inner portion; and a handle including: a first hub coupled to the inner portion of the sheath member; and a second hubcoupled to the outer portion of the sheath member, wherein, when the first hub is translated away from the second hub, a length of the sheath member positioned on the outer portion transitions from the outer portion to the inner portion.

[0030] According to another example (“Example 26”), further to Example 25, the introducer sheath further includes a stiffener configured to be positioned between the inner portion and the outer portion of the sheath member.

[0031] According to another example (“Example 27”), further to Example 26, the stiffener is an elongate member defining a lumen and defining a slit along at least a portion of a longitudinal length of the stiffener.

[0032] According to another example (“Example 28”), further to Examples 26-27, the stiffener is relatively more stiff than the sheath member, wherein the sheath member has a material property of at least one of drapability, conform ability, and low bending stiffness.

[0033] According to another example (“Example 29”), further to Examples 26-28, the sheath member is configured to accommodate a component having a diameter greater than a diameter of the stiffener.

[0034] According to another example (“Example 30”), further to Examples 26-29, the introducer sheath further includes an introducer handle including a valve through which the sheath member extends.

[0035] According to another example (“Example 31”), further to Example 30, the introducer handle includes a port through which the stiffener extends.

[0036] According to another example (“Example 32”), further to Example 31 , an inner opening of the port is aligned to provide access to a space between the first hub and the second hub.

[0037] According to another example (“Example 33”), further to Examples 26-32, at least a portion of the inner portion of the sheath member is relatively stiffer than the outer portion of the sheath member.

[0038] According to another example (“Example 34”), further to Examples 26-33, at least a portion of the inner portion of the sheath member includes an integral stiffener.

[0039] According to another example (“Example 35”), further to Examples 26-34, at least a portion of the outer portion of the sheath member includes pores through which at least one of a fluid and a therapeutic is deliverable.

[0040] According to another example (“Example 36”), further to Example 26,the stiffener defines a first longitudinal edge portion adjacent to a first longitudinal edge and a second longitudinal edge portion adjacent to a second longitudinal edge, wherein the first and second longitudinal edge portions at least partially overlap to define a split key-ring profile of the stiffener.

[0041] According to another example (“Example 37”), further to Example 36, the stiffener includes a leading edge, a first angled edge extending between the leading edge and the first longitudinal edge, and a second angled edge extending between the leading edge and the second longitudinal edge.

[0042] According to another example (“Example 38”), further to Example 26 handle includes a port configured to receive the stiffener, wherein the port defines an inner opening, wherein the handle defines a positioner positioned adjacent the inner opening configured to position the stiffener about at least a portion of a circumference of the inner portion of the sheath member.

[0043] According to another example (“Example 39”), further to Example 38, the positioner includes a first structure coupled to a second structure, wherein first structure is sized at a first end such that the stiffener can be positioned about the first structure.

[0044] According to another example (“Example 40”), further to Example 39, the sheath member is operable to invert during removal from the vessel

[0045] According to another example (“Example 41”), further to Example 39, the sheath member is operable to translate into the vessel during insertion or evert into the vessel during insertion.

[0046] According to another example (“Example 42”), a delivery system includes the introducer sheath of Example 25 and further includes a dilator positioned in the lumen defined by the inner portion of the sheath member; and an endoluminal device positioned on a catheter and constrained by a constraining member to a delivery diameter, wherein the inner portion of the sheath member has a diameter that is greater than the delivery diameter of the endoluminal device such that the endoluminal device is longitudinally moveable through the sheath member.

[0047] According to one example (“Example 43”), a method of assembling an introducer sheath includes everting or inverting a sheath member such that the sheath member defines an inner portion defining a lumen through which an endoluminal device may be advanced and an outer portion surrounding at least a portion of the inner portion, wherein a first hub is coupled to the inner portion of thesheath member and a second hub is coupled to the outer portion of the sheath member; and inserting a stiffener between an inner portion and an outer portion of the sheath member.

[0048] The foregoing Examples are just that and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.

[0050] FIG. 1 is an introducer sheath assembly in accordance with an embodiment; and

[0051] FIGS. 2A and 2B are hubs forming handles for an introducer sheath assembly in accordance with various embodiments;

[0052] FIG. 3A includes the various components of an introducer sheath assembly in accordance with an embodiment;

[0053] FIG. 3B includes the various components of the introducer sheath assembly of FIG. 3A in an assembled state;

[0054] FIGS. 4A-4H illustrate an introducer assembly at various times during use of the introducer assembly, in accordance with an embodiment;

[0055] FIG. 5 is an introducer sheath with features that may be included in various embodiments, including those shown in any of the previous FIGS, in accordance with an embodiment;

[0056] FIGS. 6A-6L illustrate an exemplary insertion of an introducer assembly into a vessel, delivery of an endoluminal device, and removal of the introducer assembly from the vessel, in accordance with an embodiment;

[0057] FIGS. 7A-7C are illustrations of various embodiments of stiffeners; and

[0058] FIGS. 8A-8D are various views of a handle with a port for insertingstiffeners, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0059] This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

[0060] With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, minor adjustments made to optimize performance and / or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and / or manipulation of objects by a person or machine, and / or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.Description of Various Embodiments

[0061] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. The disclosure relates generally to introducer sheaths and introducer sheath assemblies.

[0062] The introducer sheath assembly 10 shown in FIG. 1 is provided as an example of the various features of an introducer sheath assembly and, although thecombination of those illustrated features is clearly within the scope of invention, that example and its illustration is not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown in FIG.1 . For example, in various embodiments, the hubs of the introducer sheath shown in FIG. 1 may include the profiles or ports described with reference to FIGS. 2A-3 or the various other features shown in FIG. 5. It should also be understood that the reverse is true as well. One or more of the components depicted in FIG. 1 can be employed in addition to, or as an alternative to components depicted in FIG. 2.

[0063] An introducer sheath assembly 10 can be inserted into a patient to provide access into the anatomy of a patient (e.g., vasculature or other lumens or cavities). The introducer sheath assembly 10 is configured to limit or reduce trauma to the surrounding tissue when the introducer sheath assembly 10 is inserted and removed from the anatomy of the patient. The introducer sheath assembly 10 can reduce or limit shear force between the introducer sheath assembly 10 and the surrounding tissue during insertion and removal of the introducer sheath assembly 10. The introducer sheath assembly 10 is capable of facilitating insertion of surgical, endoscopic, transcatheter, and other devices into the body. The introducer sheath assembly 10 can facilitate insertion of devices having a larger diameter than the original diameter of the introducer sheath assembly 10 during initial insertion or cannulation of the introducer sheath assembly 10 into the patient.

[0064] Referring to FIG. 1 , an embodiment of the introducer sheath assembly 10 is shown. The introducer sheath assembly 10 includes a sheath member 12, a first hub 14, a second hub 16, a stiffener 18, and a dilator 20. The sheath member 12 and the dilator 20 are operable to be inserted into a patient to provide an access site for procedures. The dilator 20 can be removed to provide access through the hubs 14, 16 and sheath member 12, through which devices and implements may be delivered. The stiffener 18 may be positioned with the sheath member 12 (e.g., within) to provide longitudinal support to the sheath member 12 during use.

[0065] In some embodiments, the sheath member 12 includes a lumen 21 , an inner portion 22 (e.g., defining the lumen 21 ) through which an endoluminal device may be advanced, and an outer portion 24 surrounding at least a portion of the inner portion 22 (see FIG. 4A). The sheath member 12 may be formed of a film, laminate, or other material that is pliable and provides sufficient strength to resistabrasion or tears during insertion, removal, movement, or articulation of components when positioned through the sheath member 12. Some non-limiting examples of materials that may be implemented, either alone or in combination, include an expanded polytetrafluoroethylenes (ePTFE), polypropylenes, or expanded polyethylene (ePE), and so forth. These example materials may be utilized in a membrane form, as tapes, films, wraps, overwraps, and so forth.In some embodiments, the sheath member 12 may be formed of a material that is flexible or flimsy such that it has a low bending resistance. Additionally, the sheath member 12 is formed of a thin material. For example, the material may have a thickness of about 0.010 mm to about 0.200 mm. In some embodiments, the material has a thickness from about 0.010 mm to about 0.015 mm, from about 0.015 mm to about 0.020 mm, from about 0.020 to about 0.025 mm, from about 0.025 mm to about 0.030 mm, from about 0.030 to about 0.035 mm, from about 0.035 mm to about 0.040 mm, from about 0.040 mm to about 0.045 mm, from about 0.045 mm to about 0.050 mm, from about 0.050 mm to about 0.060 mm, from about 0.060 mm to about 0.070 mm, from about 0.070 mm to about 0.080 mm, from about 0.080 mm to about 0.090 mm, from about 0.090 mm to about 0.100 mm, from about 0.120 mm to about 0.120 mm to about 0.140 mm, from about 0.140 mm to about 0.160 mm, from about 0.160 mm to about 0.180 mm, and from about 0.180 mm to about 0.200 mm. The thickness of the material facilitates a low profile to decrease the size of the sheath member 12 during insertion. Other material properties of the sheath member 12 may include at least one of drapability, conformability, low bending stiffness, abrasion resistance, puncture resistance, lubricious, and high tensile strength. In some embodiments, the sheath member 12 is formed of a composite film including a densified ePTFE film covered with a thin non-porous layer of fluorinated ethylene propylene (FEP) (approximately 0.24 wt% of the composite film). The composite film may include the following properties: Mass per area (MPA) of about 17.42 g / m2, thickness of about 0.0076 mm, a longitudinal tensile (machine direction; MD) strength of about 288 MPa, a transverse tensile strength (TD) of about 68.3 MPa, and an isopropyl alcohol (IPA) bubble point (measured according to ASTM F316-86) of about 586 kPa. In some embodiments, a biaxially-oriented expanded ultra-high molecular weight polyethylene (UHMWPE) film may be implemented with the sheath member 12. The biaxially-oriented expanded UHMWPE film was prepared according to the generally methodology for casting and orienting gel-processed polyethylenefilms. The UHMWPE film had the following properties: Mass per area (MPA) of about 2.3 g / m2, thickness of about 0.0031 mm, a mean flow pore size (MFP) of approximately 0.000221 mm, a longitudinal tensile (machine direction; MD) strength of about 264 MPa, and a transverse tensile strength (TD) of about 366 MPa.

[0066] The sheath member 12 may be everted or inverted to define the inner and outer portions 22, 24. It is understood that regardless of whether the sheath member 12 is inverted or everted, the process defines the inner and outer portions 22, 24 as defined herein with a movable transition portion 23. Thus, in some embodiments, the inner and outer portions 22, 24 are continuous with each other. When the sheath member 12 is everted, a transition portion 23 (e.g., fold) may be defined between the inner and outer portions 22, 24. The transition portion 23 defines the portion that transitions the sheath member 12 between the inner and outer portions 22, 24. As will be discussed in more detail, the inner, transition, and outer portions 22, 23, 24 are defined by their relative positions and orientations rather than specific lengths of the sheath member 12. This is because during use the sheath member 12 may be actuated to cause portions of the sheath member 12 that are defined as the outer portion 24 to transition (e.g., via inward eversion) from being positioned outward of the inner portion 22 to being part of the inner portion 22 via the transition portion 23. The opposite is also true in that the sheath member 12 may be actuated to cause portions of the sheath member 12 that are defined as the inner portion 22 to transition (e.g., via outward eversion) from being positioned inward of the outer portion 24 to being part of the outer portion 24. In some embodiments, the inner and outer portions 22, 24 as included in a delivery configuration (see FIG. 4A) may be formed of different materials or of different thicknesses of materials. For example, the inner portion 22 may be thicker than the outer portion 24. This facilitates the outer portion 24 to be more compliant for inward eversion as discussed herein whereas the inner portion 22 is operable to facilitate the passing of the endoluminal device 100 therethrough. In some embodiments, the inner portion 22 may be overwrapped to be thicker than the outer portion 24. A space 25 is defined between the inner portion 22 and the outer portion 24. The space 25 is configured to receive a stiffener 18 therein, which is discussed in more detail hereafter.

[0067] Referring still to FIG. 1 , the introducer sheath assembly 10 includes a first hub 14 coupled to the inner portion 22 (e.g., a first end 26) of the sheath member 12 and a second hub 16 coupled to the outer portion (e.g., a second end28) of the sheath member 12 (see FIG. 4A). The first hub 14 and the second hub 16 may be operable to couple to each other to define at least a portion of a handle 30 (e.g., a rotational coupling such as a threaded engagement, snap and detent engagements, fasteners, buckles, and so forth). FIGS. 2A and 2B illustrate additional embodiments of the first and second hubs 14, 16. The first and second hubs 14, 16 can selectively be coupled and uncoupled from each other. When the first and second hubs 14, 16 are uncoupled from each other, the first hub 14 may be actuated (e.g., translated) away from the second hub 16 in order to cause inward eversion of at least a portion of the sheath member 12 (e.g., the transition portion 23 moves distally). The first and second hubs 14, 16 include lumens through which endoluminal devices may be advanced. The first and second hubs 14, 16 are generally coaxially aligned with each other and coaxially aligned with at least a portion of the sheath member 12. The first and second hubs 14, 16 are positioned such that they are longitudinally aligned with each other when coupled, the inner portion 22 of the sheath member 12 extending from the first hub 14 and through the lumen of the second hub 16 (see FIG. 4A). The sheath member 12 continues to extend away from the second hub 16 (e.g., the inner portion 22), then doubles back (e.g., the transition portion 23), and extends to the second hub 16 (e.g., the outer portion 24).

[0068] In some embodiments, a stiffener 18 may be provided with the introducer sheath assembly 10. The stiffener 18 is operable to provide columnar strength to the sheath member 12. This allows the sheath member 12 to be advanced through the insertion site and into the tissue without substantial collapsing, longitudinal compaction, or bunching. The stiffener 18 is relatively stiffer than the sheath member 12 which facilitates the ability to impart columnar strength to the introducer sheath assembly 10 during insertion. For example, the sheath member 12 may be formed of a supple material to allow the sheath member 12 to collapse to a smaller diameter for ease of introduction and expand outward during use, the stiffener 18 being of a relatively stiffer material to provide the columnar strength to the sheath member for insertion. In some embodiments, the stiffener 18 is configured to be positioned between the inner portion 22 and the outer portion 24 of the sheath member 12 (see FIG. 4A). The stiffener 18 may include a first end 40 and a second end 42. The first end 40 may be inserted or positioned between the inner and outer portion 22, 24, the first end 40 being advanced to contact the transitionportion 23 of the sheath member 12 in order to provide columnar support to, lengthen, and / or elongate the sheath member 12. In those embodiments in which the stiffener 18 is operable to collapse the sheath member 12 to a smaller diameter, the stiffener 18 may be provided in a manner such that the stiffener 18 has a predefined shape (e.g., a C-shape) to which the stiffener 18 is configured to return. The sheath member 12 is conformable such that when positioned with the stiffener 18, the sheath member 12 is collapsible to a smaller diameter.

[0069] For example, in some embodiments the sheath member 12 may be provided with about a 10 mm inner diameter but is constrained to about a 5 mm diameter by the stiffener 18. In other examples the sheath member 12 includes an inner diameter of about 3 mm to about 4 mm, from about 4 mm to about 5 mm, from about 5 mm to about 6 mm, from about 6 mm, to about 7 mm, from about 7 mm to about 8 mm, from about 8 mm, to about 9 mm, from about 9 mm to about 10 mm, from about 10 mm to about 11 mm, from about 11 mm to about 12 mm, from about 12 mm to about 13 mm, from about 13 mm to about 14 mm, and from about 14 mm to about 15 mm. The stiffener 18 includes a diameter relatively smaller than the inner diameter of the sheath member 12, such that the sheath member 12 is reduced to a smaller profile when engages with the stiffener 18. In some embodiments, the sheath member 12 is reduced from having an inner diameter of about 10 mm to having an outer diameter from about 4 mm to about 9 mm, an inner diameter of about 9 mm to having an outer diameter from about 4 mm to about 8 mm, an inner diameter of about 8 mm to having an outer diameter from about 3 mm to about 7 mm, an inner diameter of about 7 mm to having an outer diameter from about 3 mm to about 6 mm, an inner diameter of about 6 mm to having an outer diameter from about 3 mm to about 5 mm, an inner diameter of about 5 mm to having an outer diameter from about 2 mm to about 4 mm, an inner diameter of about 4 mm to having an outer diameter from about 2 mm to about 3 mm, or an inner diameter of about 3 mm to having an outer diameter of about 2 mm. The reduction of diameter may be facilitated by the shape of the stiffener 18 and may result in pleats, folds, or corrugations of the sheath member 12. As discussed herein, the sheath member 12 is configured to expand from the reduced diameter toward the larger diameter when components (e.g., an endoluminal device 100 and delivery system) are passed through the lumen 21. In those embodiments in which the stiffener 18 may expand to accommodate those components, this may occur when the stiffener 18 is stillengaged with the sheath member 12 or this may occur during removal of the stiffener 18.

[0070] In some embodiments, the stiffener 18 is an elongate member defining a lumen. The lumen allows the stiffener 18 to at least partially surround the inner portion 22 of the sheath member 12. The stiffener 18 may include at least one slit 44 along at least a portion of a longitudinal length of the stiffener 18 including extending to a proximal end 19 of the stiffener 18. The slit 44 facilitates both expansion of the diameter of the stiffener 18 and also simplifies insertion and removal of the stiffener 18 into the space 25 defined between the inner and outer portions 22, 24 of the sheath member 12. The stiffener 18 can include any number of slits 44. For example, FIG. 3A illustrates a stiffener 18 with two slits 44. In some embodiments, the stiffener 18 may include a single slit to define a C-shaped profile. In some embodiments, the stiffener 18 may include the slit 44 in which longitudinal edge portions of the stiffener 18 that are adjacent to the slit overlap (see FIGS. 7B and 7C and associated discussion hereafter). Stated otherwise, the stiffener 18 that has a C-shaped profile may be compressed or circumferentially tightened so as to define an overlapped configuration (e.g., the C-shaped profile compressing into a spiral or split key-ring profile), which may contribute to reduction of kinking and allow for robust reintroduction (e.g., increased columnar strength). The slit allows the stiffener 18 to be installed or slid over the inner portion 22 of the sheath member 12 from a transverse direction from the axis of the sheath member 12 without having to traverse or accommodate the hubs 14, 16. As previously stated, the slit 44 also facilitates accommodating components that are inserted through the lumen 21 of the sheath member 12 when the stiffener 18 is engaged with the sheath member 12. The slit 44 defining the C-shaped profile allows for radial expansion when a component having a larger diameter than the stiffener 18 is engaged with the sheath member 12 and the component is slid therethrough. It is also understood that the sheath member 12 may be oversized to allow for expansion. For example, in some embodiments, the sheath member 12 may have a diameter that is greater than the diameter of the stiffener 18 (e.g., when the stiffener 18 is in a delivery configuration or in an expanded diameter configuration). Because the sheath member 12 is pliable, the sheath member 12 may be constrained to a delivery configuration (e.g., by the stiffener). However, the sheath member 12 may be expanded when components are inserted which require additional space. Thus, the sheath member12 may include the smaller profile (e.g., delivery configuration) in order to facilitate insertion into the patient but then may expand to an expanded diameter configuration to accommodate larger diameter components. The stiffener 18 (e.g., the C-shaped profile embodiment) may then be implemented to bias the sheath member 12 back to a reduced diameter configuration (e.g., the delivery configuration). In some embodiments, the stiffener 18 may include a tapered profile along at least a portion of the longitudinal length of the stiffener.

[0071] Turning to FIGS. 2A and 2B, the hubs 14, 16 may include a port 32. The port may be positioned on either the first hub 14 (e.g., FIG. 2A) or the second hub 16 (e.g., FIG. 2B). The port 32, in some embodiments, facilitates access to the space 25 between the inner and outer portions 22, 24 of the sheath member 12. In some embodiments, the port 32 includes an inner opening that is positioned longitudinally between the first hub 14 and the second hub 16. The port 32 may be utilized for insertion and removal of the stiffener 18 into and out of the space 25 between the inner and outer portions 22, 24 of the sheath member 12. The port 32 may include features to facilitate insertion of the stiffener 18 into the space 25. For example, when the stiffener 18 includes a C-shaped profile, the port 32 may include markings to help facilitate appropriate clocking of the stiffener 18 such that the slit 44 is able to traverse over the inner portion 22 such that the stiffener 18 can at least partially surround the inner portion 22. The port 32 may also be used to provide access to the space 25 between the inner and outer portions 22, 24 for other reasons. For example, the port 32 may be implemented to provide a fluid therebetween to at least partially inflate the outer portion 24. Additionally, the outer portion 24 may also be porous or perforated over at least a portion of the surface such that the port 32 may be used to fill the space with a fluid (e.g., drug, saline, therapeutic, etc.) to deliver the fluid through the outer portion 24 to the surrounding tissue or into the lumen (e.g., vasculature) of the patient.

[0072] In some embodiments, the handle 30 may include additional ports and accessories. For example, the first or second hubs 14, 16 may include a valve assembly 34, in order to limit fluid leak from the hubs during use.

[0073] Returning to FIG. 1 , the introducer sheath assembly 10 may include a dilator 20. The dilator 20 may be positioned in the lumen 21 defined by the inner portion 22 of the sheath member 12. The dilator 20 is configured to provide support to the sheath member 12 during insertion. The dilator 20 may be a flexible,elongated dilator which, in some embodiments, may be provided with a hub 50 and lock knob (not shown) for engaging the handle 30. The dilator 20 may be inserted through the valve assembly 34, hubs 14, 16, and sheath member 12. The annular portion of the hub 50 radially aligns the dilator 20 relative to the valve assembly 34 and sheath member 12. In some embodiments, the dilator 20 may include a lock to maintain relative position with the handle 30. The introducer sheath assembly 10, with the sheath member 12, valve assembly 34, and dilator 20 axially locked via the locking engagement, may be inserted into the patient. After dilating the intended endovascular delivery path, the dilator 20 can be removed while the sheath member 12 remains in place. The dilator 20 can be completely removed by continued axial separation from the handle 30.

[0074] In some embodiments, the dilator 20 includes a dilator tip 52 and dilator body 54, wherein at least a portion of the dilator tip 52 has a diameter that is larger than a diameter of the dilator body 54 (see FIG. 5). This facilitates insertion of the introducer sheath assembly 10 without the sheath member 12 being caught and held by tissue as it is advanced. For example, at least a portion of the dilator tip 52 may be flush with the outer portion 24 of the sheath member 12 or may have a diameter greater than the outer portion 24 of the sheath member 12 when the sheath member 12 is in a delivery configuration. Both the leading and trailing ends of the dilator tip 52 may be tapered (e.g., curved taper or straight taper). The leading end taper may facilitate dilation of the tissue during insertion. Because the dilator tip 52 has a diameter that is similar to or larger than the diameter of the outer portion 24 of the sheath member 12 when in the delivery configuration, the dilator tip 52 protects the sheath member 12 during insertion and reduces the likelihood of snags and / or trauma to the vessel that might occur during insertion as a result of the leading end of the sheath member 12. The dilator 20 is removable from the lumen 21 of the sheath member 12. In those embodiments with a larger diameter dilator tip 52, and in which the trailing end of the dilator tip 52 includes a taper, dilator tip 52 may facilitate removal of the dilator 20 from the sheath member 12 by using the taper as a ramped surface to ensure the dilator tip 52 does not snag on the sheath member 12.

[0075] Referring to FIG. 5, in some embodiments, at least a portion of the inner portion 22 of the sheath member 12 is relatively stiffer (e.g., greater stiffness) than the outer portion 24 of the sheath member 12. In these embodiments, the innerportion 22 may act as an integral stiffener. The inner portion 22 may be stiffened by treatments of the material to increase stiffness and columnar strength, components may be added to increase stiffness (e.g., wire frames, etc.), or may be defined by the stiffener 18. For example, in some embodiments, the inner portion 22 may be formed by a stiff material to which the outer portion 24 is coupled (e.g., end-to-end).

[0076] Turning now to a discussion of FIGS. 3A and 3B, a method of assembly is shown with the various components. The method of assembling the introducer sheath assembly 10 includes everting a sheath member 12 such that the sheath member 12 defines an inner portion 22 defining a lumen 21 through which an endoluminal device may be advanced and an outer portion 24 surrounding at least a portion of the inner portion 22. The inner portion 22 is shown in FIG. 3A with at least a portion not surrounded by the outer portion 24 (e.g., the sheath member 12 not everted). The introducer sheath assembly 10 includes a first hub 14 coupled to the inner portion 22 of the sheath member 12 and a second hub 16 is coupled to the outer portion 24 of the sheath member 12. The method includes inserting a stiffener 18 between an inner portion 22 and an outer portion 24 of the sheath member 12, and inserting a dilator 20 through the lumen 21 . In some embodiments, the method includes coupling the first hub 14 and the second hub 16 together.

[0077] Turning now to FIGS. 4A-4H, an exemplary sequence of use of the introducer sheath is illustrated. An entry point near the vasculature 1000 into the anatomy is illustrated to provide the relative position of components during use, in some embodiments. The sequence may not necessarily be implemented chronologically as various reasons may necessitate or may facilitate certain steps out of sequence with what is shown herein. However, those steps that may be implemented out of the sequence provided herein are within the scope of the present disclosure. Furthermore, the components are not necessarily drawn to scale and may be provided as such for clarity.

[0078] Referring first to FIG. 4A, the introducer sheath assembly 10 is shown in an assembled configuration. The introducer sheath assembly 10 includes the sheath member 12 with the inner and outer portions 22, 24 coupled to the first and second hubs 14, 16, respectively, the stiffener 18 positioned between the inner and outer portions 22, 24, and the dilator 20 extending through the lumen 21 of the sheath member 12. The valve assembly 34 is also shown which limits flow of fluids through the lumen 21 to and from the body, both when components are positionedtherethrough and when no components are positioned in the lumen 21 . A guidewire 60 is also shown.

[0079] Referring to FIG. 4B, once the introducer sheath assembly 10 is inserted into the patient to establish an insertion site, the dilator 20 may be removed from the introducer sheath assembly 10 to provide access through the lumen 21 such that other devices may be delivered through the sheath member 12. The stiffener 18 may also be removed from between the inner and outer portions 22, 24(however, in some embodiments the stiffener 18 may be maintained in position). With the dilator 20 removed, the lumen 21 is free (e.g., clear and available) and may be used for insertion of components therethrough, including components with larger diameters than the sheath member 12, which may be accommodated by the sheath member 12 having an expanded diameter configuration as previously discussed (likewise, stiffener 18 may also have an expanded diameter configuration in accordance with some embodiments). It is also understood that the sheath member 12, when in position with the vasculature, does not longitudinally move or is longitudinally static in position along the surfaces contacting the vasculature during use, meaning that the sheath member 12 does not longitudinally slide along or relative to the vasculature once in position.

[0080] Referring to FIG. 4C, the endoluminal device 100, constrained by a constraining member (not shown) to a delivery diameter, is shown being delivered through the introducer sheath assembly 10. The endoluminal device is carried on a catheter 102 which both pass through the lumen 21. FIG. 4D illustrates the endoluminal device 100 deployed to a delivery configuration. Although shown proximate to the introducer sheath assembly 10, it is understood that the endoluminal device may be deployed away from the introducer sheath assembly 10 including at positions further away from the introducer sheath assembly 10 as the introducer sheath assembly 10 acts as an insertion site.

[0081] Referring to FIG. 4E, once the endoluminal device 100 is deployed, in some embodiments, the stiffener 18 may be reinserted to support the sheath member 12. This may be advantageous as the catheter 102 is being retracted through to limit snagging and pulling back the sheath member 12. The stiffener 18 provides columnar strength to resist being pulled out with the catheter 102. FIG. 4F illustrates the catheter 102 during removal.

[0082] Referring to FIG. 4G, once the catheter 102 is removed and the procedure is ending, the introducer sheath assembly 10 may be ready for removal from the patient. During some procedures, including long procedures, there may be some adhesion of the sheath member 12 to the surrounding tissue. In order to limit shear force and resulting trauma to the surrounding tissue, the first hub 14 is actuated away from the second hub 16. This results in the inward eversion of portions of the outer portion 22 of the sheath member 12. This allows the sheath member 12 to be pulled away from the tissue without imparting a shear force on the tissue (e.g., peeled away). The stiffener 18, if inserted, may translate back with the sheath member 12 as the sheath member 12 is inverted during removal, wherein the transition portion 23 translates distally during the removal process. It is understood that the transition portion 23 is defined not by a specific longitudinal location on the sheath member 12, but is instead defined by the position at which the sheath member 12 transitions from the inner portion 22 and the outer portion 24, which moves as described herein, during inversion and / or eversion. This arrangement allows for the introducer sheath assembly 10, and specifically the outer portion 24 to be removed from the vessel wall without sliding against the vessel wall but instead peals from the vessel wall (e.g., moved away from the vessel wall at an angle rather than translated along the vessel wall), which reduced potential trauma caused by adhesion of the outer portion 24 to the vessel wall. It is understood that in some embodiments, the outer portion 24 can be inserted using a similar everting arrangement or may be inserted into place using a sliding motion as adhesion has not yet occurred. In some embodiments, the space 25 may be pressurized or inflated to help destabilize any adhesion between the sheath member 12 and surrounding tissue. In some embodiments, fluids may be delivered through the outer portion 24 as previously discussed, which may also limit adhesion or help break up adhesion between the sheath member 12 and the surrounding tissue. FIG. 4H illustrates an embodiment in which the stiffener 18 is removed prior to actuation of the second hub 16 resulting in inward eversion of the sheath member 12.

[0083] In some embodiments, the sheath member 12 may be generally fluid impermeable (except as otherwise described). For example, the sheath member 12 may be made of a material that inhibits or reduces passage of blood, bile and / or other bodily fluids and materials through the sheath member 12. In certain instances, the sheath member 12 has a material composition and configuration that inhibits orprevents tissue ingrowth and / or endothelialization or epithelialization into the covering material.

[0084] Turning to a discussion of FIGS. 6A-6L, an exemplary embodiment of an introducer sheath assembly 10 is shown being implemented in a patient’s vessel for delivery of an endoluminal device 100. Referring to FIGS. 6A and 6B, illustrate insertion of the introducer sheath assembly 10 into the patient’s vasculature 1000. The introducer sheath assembly 10 includes a sheath member 12 that is supported by a stiffener 18 in order to provide columnar strength for insertion. The dilator 20 and the sheath member 12 are inserted into a lumen of the vasculature. Because the dilator 20 and the sheath member 12 have a diameter that is less than the diameter of the vasculature, the likelihood of trauma to the vasculature is reduced. Additionally, the introducer sheath assembly 10 is shown being inserted from the side of the vasculature, but is capable of turning so as to travel through the vasculature or to provide access into the vasculature for transcatheter procedures, for example.

[0085] FIGS. 6C and 6D illustrate removal of the dilator 20 from the sheath member and the hubs 14, 16. The dilator 20 is removed from the lumen 21 of the sheath member 12. This allows the lumen 21 to be free (e.g., clear and available) such that additional components may be positioned, advanced, or retracted therethrough. FIGS. 6G and 6H illustrate the endoluminal device 100 being delivered through the lumen 21 of the sheath member 12. As previously discussed, the sheath member 12 is capable of expanding its diameter as components are positioned therein. In the embodiment shown herein, the sheath member 12 expands such that the sheath member 12 is contacting the surrounding vasculature.

[0086] FIGS. 6I illustrates the endoluminal device being positioned at a target site for delivery. It is understood that in some embodiments, a portion of the sheath member 12 may be positioned between the endoluminal device 100 and the vasculature after the endoluminal device 100 is deployed. The introducer sheath assembly 10 as described herein further facilitates removal from both the vessel wall as well as from positions in which it may be pinned against endovascular devices and the vasculature. FIG. 6J illustrates the introducer sheath assembly 10 after deployment of the endoluminal device 100 and the delivery system thereof. FIGS. 6K and 6L illustrate removal of the sheath member 12 and introducer sheath assembly 10 from the vasculature. This is accomplished by actuating the first hub such that thesheath member 12 everts inwardly to peel away from the vasculature if adhesion has occurred. This limits trauma to the vasculature during removal.

[0087] Turning to FIGS. 7A-7C, the stiffener 18 may be provided in various configurations. The stiffener 18 includes a first longitudinal edge 112 and a second longitudinal edge 114. The first and second longitudinal edges 112, 114 are defined substantially longitudinally along the stiffener 18, for example, substantially parallel to the longitudinal axis of the stiffener 18. FIG. 7A illustrates the C-shape configuration as previously discussed in which the first and second longitudinal edges 112, 114 are spaced from each other so as to define a gap. FIG. 7B illustrates the coil or split key-ring configuration in which first and second longitudinal edge portions that are adjacent to the first and second longitudinal edges 112, 114, respectively, overlap each other such that a portion of the stiffener 18 includes two layers. The stiffener of FIG. 7B includes a relaxed configuration in which the first and second longitudinal edges 112, 114 extend beyond each other such that first and second longitudinal edge portions 113, 115 at least partially overlap. The stiffener 18 is pliable such that the first and second longitudinal edges 112, 114 may be deflected away from each other when a force is applied or a structure is positioned therebetween. FIG. 7C illustrates a similar split key-ring configuration as illustrated in FIG. 7B, and further includes a first angled edge 116 and a second angled edge 118. The stiffener 18 includes a leading edge 110 and the first angled edge 116 that extends between the leading edge 110 and the first longitudinal edge 112. The second angled edge 118 extends between the leading edge 110 and the second longitudinal edge 114. The first and second angled edges 116, 118 define ramps which are configured to facilitate deflection and opening (e.g., dilation) of the stiffener 18 such that the stiffener 18 may be more readily placed about at least a portion of the sheath member 12 (e.g., about the inner portion 22 and within the space 25).

[0088] Turning now to FIGS. 8A-8C, the handle 30 includes the port 32 defining the inner opening for providing access to the space 25 for insertion of the stiffener 18 (see also FIG. 3A and 4A). The stiffener 18 can be inserted into and removed from the space 25 between the inner and outer portions 22, 24 of the sheath member 12 via the port 32 in order to support the sheath member 12 (see FIG. 6A). In some embodiments, the handle 30 includes a positioner 120 that is configured to facilitate the stiffener 18 being placed about at least a portion of the sheath member 12. The positioner 120 is configured to facilitate clocking (e.g.,positioning the slit 44) of the stiffener 18 to engage the sheath member 12. In some embodiments, the positioner 120 is positioned adjacent the inner opening and configured to position the stiffener 18 about at least a portion of a circumference of the inner portion 22 of the sheath member 12. The positioner 120 may include a first structure 122 that is coupled to the handle 30 via a second structure 124. The first structure 122 is sized at a first end 130 such that the interior space of the stiffener 18 can be positioned about the first structure 122. The second structure 124 is narrow at the first end 130. The second structure 124 is configured to act as an edge to facilitate opening of the stiffener 18 at the slit 44. Moving from the first end 130 toward a second end 132, the second structure 124 widens. Thus, as the stiffener 18 is advanced along the positioner 120, the stiffener 18 is deflected open further (e.g., the stiffener 18 is dilated). The second structure 124 is wide enough at an interface between the sheath member 12 and the port 32 such that the stiffener 18 is transferred onto the sheath member 12 such that the stiffener 18 extends at least partially about a circumference of the stiffener 18 (e.g., the inner portion 22). It is noted that the first structure 122 may include a protrusion (e.g., a cone, not shown) to help facilitate engagement and / or centering of the stiffener 18 with the first end 130 of the positioner 120.

[0089] FIG. 8A illustrates the positioner 120 at the first end 130. FIG. 8B illustrates a cross section of the handle 30 at a position between the first end 130 and the second end 132 of the positioner 120 illustrating the profile of the port 32 and the positioner 120 that facilitates deflection for insertion of the stiffener 18. FIG. 8C illustrates a cross section of the handle 30 at a position proximate the second end 132 of the positioner 120 near the interface with the stiffener 18 (not shown). This configuration allows the stiffener 18 to snap about the sheath member 12. It can be appreciated that the first angled edge 116 and the second angled edge 118 of the embodiment of the stiffener 18 shown in FIG. 7C may be implemented with the positioner 120 such that the first angled edge 116 and the second angled edge 118 contact the second structure 124 in order to initiate deflection of the stiffener (e.g., the first and second longitudinal edges 112, 114) as the stiffener 18 is advanced into the port 32. In this the manner, the first angled edge 116 and the second angled edge 118 act as ramps to initiate deflection or dilation of the stiffener 18. FIG. 9 shows the stiffener 18 positioned through the port 32, wherein the positioner 120 is facilitating opening, deflection, or splaying of the longitudinal edges 112, 114 of thestiffener 14.

[0090] The sheath member 12 may include a fluoropolymer membrane, such as an expanded polytetrafluoroethylene (ePTFE) polymer, polyvinylidene fluoride (PVDF), or polyvinylidene acetate (PVDA). In other instances, the covering material comprises a polyolefin (e.g., polyethylene or expanded polyethylene), a polyester, a silicone, a urethane, biocompatible polymer(s), polyethylene terephthalate (e.g., Dacron®), copolymers, or combinations thereof. These are provided as examples only and are not to be considered limiting to the materials that may be implemented.

[0091] The sheath member 12 (or portions thereof) may also be modified by one or more chemical or physical processes that enhance one or more properties including modification with a coating. For example, a hydrophilic coating may be applied to the sheath member 12 to improve the wettability and echo translucency of the covering. In certain instances, the sheath member 12, or portions thereof, may be modified with chemical moieties that facilitate one or more biological responses, resistance to adhesion, and resistance to thrombosis. In certain instances, the sheath member 12, or portions thereof, may be modified to resist biofouling. In addition, the sheath member 12, or portions thereof, may be modified with one or more covalently attached drug substances (e.g., heparin, antibiotics, and the like) or impregnated with the one or more drug substances. The drug substances can be released in situ to promote healing, reduce tissue inflammation, reduce or inhibit infections, reduce vessel constriction or vasospasm, and to promote various other therapeutic treatments and outcomes. In some embodiments, the drug substance may be, but is not limited to a corticosteroid, a human growth factor, an anti-mitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate. In addition, a pharmacological agent may be delivered separately from the sheath member 12 to the insertion site to promote tissue healing or tissue growth.

[0092] The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. An introducer sheath assembly comprising: a sheath member operable to invert or evert, the sheath member defining a lumen, the sheath member having a material property of at least one of drapability, conform ability, and low bending stiffness; and a stiffener configured to be removably engaged with and support the sheath member, the stiffener having a stiffness that is relatively greater than a stiffness of the sheath member.

2. The introducer sheath assembly of claim 1 , wherein the sheath member includes an inner portion and an outer portion, wherein a space is defined between the inner portion and the outer portion, the space being configured to receive the stiffener therein.

3. The introducer sheath assembly of either claim 1 or claim 2, further comprising: a dilator removably positioned in the lumen of the sheath member; and a hub coupled to the sheath member, wherein, when the hub is actuated, the hub is operable to cause inward eversion of at least a portion of the sheath member.

4. An introducer sheath for introducing a transcatheter component into a body of a patient, the introducer sheath comprising: a sheath member including an inner portion defining a lumen through which an endoluminal device may be longitudinally extended therethrough and an outer portion surrounding at least a portion of the inner portion; and a handle including: a first hub coupled to the inner portion of the sheath member; and a second hub coupled to the outer portion of the sheath member, wherein, when the first hub is translated away from the second hub, a length of the sheath member positioned on the outer portion transitions from the outer portion to the inner portion.

5. The introducer sheath of claim 4, further comprising a stiffener configured to be positioned between the inner portion and the outer portion of the sheath member.

6. The introducer sheath of claim 5, wherein the stiffener is an elongate member defining a lumen and defining a slit along at least a portion of a longitudinal length of the stiffener.

7. The introducer sheath of any one of claims 5-6, wherein the stiffener is relatively more stiff than the sheath member, wherein the sheath member has a material property of at least one of drapability, conformability, and low bending stiffness.

8. The introducer sheath of any one of claims 5-7, wherein the sheath member is configured to accommodate a component having a diameter greater than a diameter of the stiffener.

9. The introducer sheath of any one of claims 5-8, further comprising an introducer handle including a valve through which the sheath member extends.

10. The introducer sheath of claim 9, wherein the introducer handle includes a port through which the stiffener extends.11 . The introducer sheath of claim 10, wherein an inner opening of the port is aligned to provide access to a space between the first hub and the second hub.

12. The introducer sheath of any one of claims 5-11 , wherein at least a portion of the inner portion of the sheath member is relatively stiffer than the outer portion of the sheath member.

13. The introducer sheath of any one of claims 5-12, wherein at least a portion of the inner portion of the sheath member includes an integral stiffener.

14. The introducer sheath of any one of claims 5-13, wherein at least a portion of the outer portion of the sheath member includes pores through which at least one of a fluid and a therapeutic is deliverable.

15. The introducer sheath of claim 5, wherein the stiffener defines a first longitudinal edge portion adjacent to a first longitudinal edge and a second longitudinal edge portion adjacent to a second longitudinal edge, wherein the first and second longitudinal edge portions at least partially overlap to define a split key-ring profile of the stiffener.

16. The introducer sheath of claim 15, wherein the stiffener includes a leading edge, a first angled edge extending between the leading edge and the first longitudinal edge, and a second angled edge extending between the leading edge and the second longitudinal edge.

17. The introducer sheath of claim 5, wherein handle includes a port configured to receive the stiffener, wherein the port defines an inner opening, wherein the handle defines a positioner positioned adjacent the inner opening configured to position the stiffener about at least a portion of a circumference of the inner portion of the sheath member.

18. The introducer sheath of claim 17, wherein the positioner includes a first structure coupled to a second structure, wherein first structure is sized at a first end such that the stiffener can be positioned about the first structure.

19. The introducer sheath of claim 18, wherein the sheath member is operable to invert during removal from the vessel20. The introducer sheath of claim 19, wherein the sheath member is operable to translate into the vessel during insertion or evert into the vessel during insertion.21 .A delivery system comprising the introducer sheath of claim 4 and further comprising: a dilator positioned in the lumen defined by the inner portion of the sheath member; and an endoluminal device positioned on a catheter and constrained by a constraining member to a delivery diameter, wherein the inner portion of the sheath member hasa diameter that is greater than the delivery diameter of the endoluminal device such that the endoluminal device is longitudinally moveable through the sheath member.

22. A method of assembling an introducer sheath, comprising: everting or inverting a sheath member such that the sheath member defines an inner portion defining a lumen through which an endoluminal device may be advanced and an outer portion surrounding at least a portion of the inner portion, wherein a first hub is coupled to the inner portion of the sheath member and a second hub is coupled to the outer portion of the sheath member; and inserting a stiffener between an inner portion and an outer portion of the sheath member.

Images