Introducer systems including vessel liners

Abstract

An introducer system includes a vessel liner defining a liner lumen, and the vessel liner being expandable from a compacted configuration to an expanded configuration in a vessel. A liner hub is coupled to the vessel liner, and the liner hub is configured to remain outside of the vessel. An expander is removably positionable into the liner lumen of the vessel liner to cause the vessel liner to reconfigure from the compacted configuration to the expanded configuration in the vessel.

Description

INTRODUCER SYSTEMS INCLUDING VESSEL LINERSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of U.S. Provisional Application No. 63 / 641 ,736, entitled “INTRODUCER SYSTEMS INCLUDING VESSEL LINERS,” filed on May 2, 2024, which is incorporated by reference herein for all purposes in its entirety.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, therapeutic devices, and monitoring devices. 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, therapeutic devices, diagnostic devices, wireless monitors, dilators, guidewires, and the like. However, introducer sheaths can be sized such that trauma to tissue can occur as the introducer sheath is inserted into a patient’s anatomy. Accordingly, it is desirable to provide systems and methods that mitigate tissue trauma during introducer insertion.SUMMARY

[0004] An introducer sheath system is provided with configurations for mitigating trauma during insertion.

[0005] According to one example (“Example 1”), an introducer system including: a vessel liner defining a liner lumen, and the vessel liner being expandable from a compacted configuration to an expanded configuration in a vessel; a liner hub coupled to the vessel liner; and an expander removably positionable into the liner lumen of thevessel liner to cause the vessel liner to reconfigure from the compacted configuration to the expanded configuration in the vessel.

[0006] According to another example (“Example 2”), further to Example 1 , wherein the expander includes an introducer sheath assembly, the introducer sheath assembly defining a sheath lumen configured to receive and deliver a medical device.

[0007] According to another example (“Example 3”), further to Example 1 , wherein the expander comprises an endoluminal device deployment system.

[0008] According to another example (“Example 4”), further to Example 1 , wherein the expander includes a dilator.

[0009] According to another example (“Example 5”), further to Examples 1-4, wherein the vessel liner includes expanded polyethylene (ePE) or expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), polyetheretherketone (PEEK), or polyurethane (PU).

[0010] According to another example (“Example 6”), further to Examples 1-5, wherein the vessel liner is configured to remain in the compacted configuration when externally unconstrained and until the expander is advanced in the liner lumen of the vessel liner.

[0011] According to another example (“Example 7”), further to Examples 1-6, further including an advancer to which the vessel liner is coupled, the advancer being movable in the vessel to move the vessel liner in the vessel.

[0012] According to another example (“Example 8”), further to Examples 1-7, wherein the vessel liner is constrained adjacent to a distal tip.

[0013] According to another example (“Example 9”), further to Examples 1-8, wherein the vessel liner is configured to expand from the compacted configuration to the expanded configuration by a factor of at least two.

[0014] According to another example (“Example 10”), further to Examples 1-8, wherein the vessel liner is configured to expand from the compacted configuration to the expanded configuration by an increase of a factor of at least 0.5.

[0015] According to another example (“Example 11”), an introducer sheath system including: an expandable vessel liner defining a first lumen; a liner hub coupled to the expandable vessel liner, the liner hub defining an access opening coupled to the first lumen; and a sheath member removably positionable through the access opening of the liner hub and the first lumen of the expandable vessel liner to maintain the expandablevessel liner in an expanded configuration, the sheath member defining a second lumen configured to receive and deliver a medical device.

[0016] According to another example (“Example 12”), further to Example 11 , further including a sheath dilator removably positionable in the second lumen of the sheath member and the first lumen of the expandable vessel liner to expand the expandable vessel liner to the expanded configuration.

[0017] According to another example (“Example 13”), further to Example 12, wherein the sheath dilator includes a tapered distal tip.

[0018] According to another example (“Example 14”), further to Examples 11-13, further including a liner dilator removably positionable in the first lumen of the expandable vessel liner.

[0019] According to another example (“Example 15”), further to Example 14, wherein the liner dilator includes a tapered distal tip.

[0020] According to another example (“Example 16”), further to Examples 11-15, further including a fluid port coupled to the expandable vessel liner.

[0021] According to another example (“Example 17”), further to Examples 11-16, wherein the expandable vessel liner includes a tapered distal tip.

[0022] According to another example (“Example 18”), further to Examples 11-17, wherein the expandable vessel liner includes a plurality of longitudinal stiffening elements.

[0023] According to another example (“Example 19”), further to Example 18, wherein the plurality of longitudinal stiffening elements include folds.

[0024] According to another example (“Example 20”), further to Example 18, wherein the longitudinal stiffening elements include wires and the expandable vessel liner further includes a flexible body carried by the wires.

[0025] According to another example (“Example 21”), further to Examples 11-20, wherein the expandable vessel liner includes a longitudinal column strength sufficient to facilitate percutaneous delivery without using any separate reinforcement members.

[0026] According to another example (“Example 22”), a method of using an introducer sheath system, the introducer sheath system including a vessel liner including a first lumen and an introducer sheath member including a second lumen, the method including: advancing the vessel liner in a compacted configuration in a vessel; subsequently expanding the vessel liner to an expanded configuration in the vessel; advancing the introducer sheath member in the first lumen of the vessel liner and11thereby advancing the introducer sheath member in the vessel; and advancing a medical device in the second lumen of the introducer sheath member and thereby advancing the medical device in the vessel.

[0027] According to another example (“Example 23”), further to Example 22, wherein the medical device is an endoluminal device deployment system.

[0028] According to another example (“Example 24”), further to Examples 22-23, wherein advancing the introducer sheath member in the first lumen of the vessel liner causes the expanding of the vessel liner to the expanded configuration in the vessel.

[0029] According to another example (“Example 25”), further to Examples 22-24, wherein the introducer sheath system further includes a dilator, and advancing the introducer sheath member in the first lumen of the vessel liner includes advancing the introducer sheath member with the dilator positioned in the second lumen of the introducer sheath member.

[0030] According to another example (“Example 26”), further to Examples 22-25, wherein advancing the vessel liner in the compacted configuration in the vessel includes advancing an advancer to which the vessel liner is coupled in the vessel.

[0031] According to another example (“Example 27”), further to Examples 22-26, further including advancing a guidewire in the vessel before advancing the introducer sheath member in the vessel.

[0032] According to another example (“Example 28”), further to Example 27, wherein advancing the vessel liner in the compacted configuration in the vessel includes advancing the vessel liner along the guidewire in the vessel.

[0033] According to another example (“Example 29”), further to Examples 24-28, wherein the vessel liner remains in the compacted configuration when externally unconstrained and until the introducer sheath member is advanced in the first lumen of the vessel liner.

[0034] According to another example (“Example 30”), further to Examples 22-29, wherein advancing the vessel liner in the compacted configuration in the vessel includes advancing the vessel liner without using any separate reinforcement members.

[0035] According to another example (“Example 31”), further to Examples 22-30, wherein the vessel liner has sufficient buckling strength in the compacted configuration to inhibit collapse while advancing the vessel liner in the vessel.

[0036] According to another example (“Example 32”), further to Examples 22-31 , wherein the introducer sheath system further includes a hub coupled to the vessel liner,IIthe hub including an access opening coupled to the first lumen of the vessel liner, and advancing the introducer sheath member in the first lumen of the vessel liner includes advancing the introducer sheath through the access opening of the hub.

[0037] According to another example (“Example 33”), further to Examples 22-32, further including removing the medical device from the second lumen of the introducer sheath member and thereby removing the medical device from the vessel.

[0038] According to another example (“Example 34”), further to Example 33, further including, after removing the medical device from the vessel, removing the introducer sheath member and the vessel liner from the vessel.

[0039] According to another example (“Example 35”), further to Example 34, wherein removing the introducer sheath member and the vessel liner from the vessel includes removing the introducer sheath member from the vessel and subsequently removing the vessel liner from the vessel.

[0040] According to another example (“Example 36”), further to Examples 34-35, further including at least partially collapsing the vessel liner before removing the vessel liner from the vessel.

[0041] According to another example (“Example 37”), further to Examples 22-36, further comprising delivering a fluid to the first lumen and between the vessel liner and the introducer sheath member.

[0042] According to another example (“Example 38”), further to Examples 22-36, expanding the vessel liner to the expanded configuration in the vessel includes delivering a fluid to the first lumen of the vessel liner.

[0043] According to another example (“Example 39”), further to Example 38, delivering the fluid to the first lumen of the vessel liner includes delivering the fluid between the vessel liner and a guidewire within the first lumen of the vessel liner.

[0044] 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.IlBRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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.

[0046] FIG. 1 is a side view of an introducer system, in accordance with an embodiment;

[0047] FIG. 2 is a side view of an introducer sheath assembly of the introducer system of FIG. 1 , in accordance with an embodiment;

[0048] FIG. 3 is a side view of a vessel liner assembly of the introducer system of FIG. 1 , in accordance with an embodiment;

[0049] FIG. 4A is a cross-sectional view of a vessel liner of the introducer system of FIG. 1 in a compacted configuration, and illustrating a fold pattern for the vessel liner, in accordance with an embodiment;

[0050] FIG. 4B is a cross-sectional view of another fold pattern for the vessel liner of the introducer system of FIG. 1 , in accordance with an embodiment;

[0051] FIG. 4C is a cross-sectional view of yet another fold pattern for the vessel liner of the introducer system of FIG. 1 , in accordance with an embodiment;

[0052] FIG. 4D is a cross-sectional view of yet another fold pattern for the vessel liner of the introducer system of FIG. 1 , in accordance with an embodiment;

[0053] FIG. 5 is a cross-sectional view of the vessel liner of FIG. 4A in an expanded configuration, in accordance with an embodiment;

[0054] FIG. 6 is a schematic side view of the introducer sheath assembly prior to insertion into the vessel liner assembly of the introducer system of FIG. 1 , in accordance with an embodiment;

[0055] FIG. 7 is a schematic side view of the introducer sheath assembly being inserted into the vessel liner assembly of the introducer system of FIG. 1 , in accordance with an embodiment;

[0056] FIG. 8 is a schematic side view of the introducer sheath assembly and a medical device after being inserted into the vessel liner assembly of the introducer system of FIG. 1 , in accordance with an embodiment;

[0057] FIG. 9 is a schematic side view of the vessel liner assembly and a delivery wire of the introducer assembly of FIG. 1 , in accordance with an embodiment;11

[0058] FIG. 10 is a schematic side view of the vessel liner assembly and a liner dilator of the introducer assembly of FIG. 1 , in accordance with an embodiment;

[0059] FIG. 11 is a side view of a delivery wire of the introducer system after insertion into a vessel of a patient and the vessel liner assembly of the introducer system of FIG. 1 prior to insertion into the vessel of the patient, in accordance with an embodiment;

[0060] FIG. 12 is a side view of the vessel liner assembly of the introducer system of FIG. 1 after insertion into the vessel of the patient and the introducer sheath assembly of the introducer system of FIG. 1 prior to insertion into the vessel liner assembly and the vessel of the patient, in accordance with an embodiment;

[0061] FIG. 13 is a side view of the introducer sheath assembly of the introducer system of FIG. 1 after insertion into the vessel liner assembly of the introducer system of FIG. 1 and the vessel of the patient, in accordance with an embodiment;

[0062] FIG. 14 is a side view of the introducer sheath assembly of the introducer system of FIG. 1 after withdrawal from the vessel liner assembly of the introducer system of FIG. 1 and the vessel of the patient, in accordance with an embodiment;

[0063] FIG. 15 is a cross-sectional view of a dual lumen vessel liner, in accordance with an embodiment; and

[0064] FIG. 16 is another cross-sectional view of the dual lumen vessel liner of FIG. 15, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0065] 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.

[0066] 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 reading11and / 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

[0067] 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.

[0068] FIG. 1 illustrates an introducer system 100 that is provided as an example of the various features of an introducer system and, although the combination 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.

[0069] The introducer system 100 is partially insertable into a patient to provide access into the anatomy of the patient (for example, vasculature or other lumens or cavities, including all chambers of the heart, and including via transeptal puncture). The introducer system 100 may be sized for femoral access or radial access, for example, although a variety of access sites and paths into the vasculature or other body lumens are applicable; that is, the introducer system 100 is not limited to access via the femoral artery, iliac artery, radial artery, brachial artery, or axillary artery. For radial access, the system 100 may, for example, be sized to extend up to the brachial artery bifurcation, or to extend through the brachial artery into the thoracic arch. For femoral access, the system 100 may, for example, be sized to extend past the aortic bifurcation.

[0070] The introducer system 100 generally includes an introducer sheath assembly 102, a vessel liner assembly 104, and a guidewire 106. In use, the vessel liner assembly 104 is partially inserted into the body of the patient (for example, by advancing along the guidewire 106), and the introducer sheath assembly 102 is thenIIpartially inserted into the vessel liner assembly 104 and, as a result, partially into the body of the patient. Thereafter, one or more medical devices (for example, endoluminal device deployment systems, surgical devices, endoscopic devices, or the like) are advanced through the introducer sheath assembly 102 and into the body of the patient.

[0071] As described in further detail below, the vessel liner assembly 104 limits or reduces trauma to adjacent tissue when the introducer sheath assembly 102, which may be a large diameter introducer sheath assembly, and / or the medical devices are inserted and / or removed from the liner assembly 104 and the body of the patient. More specifically, the vessel liner assembly 104 can reduce or limit shear forces and / or tensile forces applied to the surrounding tissue during insertion and / or removal of the introducer sheath assembly 102 and / or the medical devices.

[0072] With continued reference to FIG. 1 and additional reference to FIG. 2, the introducer sheath assembly 102 includes an introducer sheath member 108 that is configured to be positioned in the body of the patient. The introducer sheath member 108 includes a sheath lumen 110 (FIG. 2) through which a sheath dilator 112 initially extends. The dilator 112 also initially extends outwardly from a distal opening 114 of the sheath lumen 110. That is, the sheath lumen 110 carries the dilator 112 when the introducer sheath assembly 102 is being positioned in the body of the patient. After the introducer sheath assembly 102 is positioned in the body of the patient, the dilator 112 is removed from the sheath lumen 110 and one or more medical devices are advanced through the sheath lumen 110 and into the body of the patient.

[0073] The introducer sheath member 108 is appropriately sized for being positioned in the body of the patient and for delivering one or more medical devices to the patient via the sheath lumen 110. For example, in some embodiments the introducer sheath member 108 has an outer diameter in a range of about 4mm (about 12 French or “Fr”) to about 10mm (about 30 Fr). In some embodiments, for example those intended for radial / brachial applications, the sheath member 108 has an outer diameter in a range of about 1 ,33mm (about 4 Fr) to 3mm (about 9 Fr). In certain embodiments, the sheath lumen 110 has a diameter in range of about 3mm (about 9 Fr) to about 9mm (27 Fr). In certain embodiments, the introducer sheath member 108 is radially expandable.

[0074] The introducer sheath member 108 is constructed of one or more materials appropriate for being positioned in and navigating the anatomy of patient, for example, high density polyethylene (HDPE), low density polyethylene (LDPE), polytetrafluoroethylene (PTFE), and the like. The introducer sheath member 108, or11portions 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 introducer sheath member 108 to increase the wettability. In certain embodiments, the introducer sheath member 108, or portions thereof, may be modified with chemical moieties that facilitate one or more biological responses, resistance to adhesion, and resistance to thrombosis. In some embodiments, the introducer sheath member 108, or portions thereof, may be modified to resist biofouling. In addition, the introducer sheath member 108, or portions thereof, may be modified with one or more covalently attached drug substances (for example, heparin, antibiotics, anti-inflammatory, sedatives-analgesics, muscle relaxants, antispasmodic, 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, for example, a corticosteroid, a human growth factor, an anti-mitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate.

[0075] With continued reference to FIGS. 1 and 2, the introducer sheath assembly 102 further includes an introducer hub 116 coupled to the sheath member 108. In use, the hub 116 remains outside of the body of the patient. The hub 116 includes a hub lumen 118 (FIG. 2) coupled to the sheath lumen 110, and the dilator 112 initially extends through the hub lumen 118 and outwardly from an access opening 120 of the sheath lumen 110. In some embodiments and as illustrated, the hub 116 couples to one or more fluid ports for selectively delivering or removing one or more fluids from the hub lumen 118 and thereby the sheath lumen 110. Illustratively, the introducer sheath assembly 102 includes a flush port 122 and a valve port 124.

[0076] With further reference to FIGS. 1 and 2 and as described briefly above, the dilator 112 is initially positioned in the hub lumen 118 and the sheath lumen 110. The dilator 112 is configured to support the introducer sheath member 108 during insertion into the body of the patient. The dilator 112 may be a flexible, elongated component which, in some embodiments, has an outer diameter sized to provide a sliding fit in the sheath lumen 110. The dilator 112 includes a tapered distal tip 126 and an opposite handle or grip 128. In some embodiments, the handle 128 is selectively lockable to the introducer hub 116. The handle 128 also facilitates withdrawing the dilator 112 from thehub lumen 118 and the sheath lumen 110 when the introducer sheath member 108 is properly positioned in the body of the patient.

[0077] With continued reference to FIG. 1 and additional reference to FIG. 3, the vessel liner assembly 104 includes a vessel liner 130 that is configured to be positioned in the body of the patient before the introducer sheath member 108 (FIG. 2). The vessel liner 130 is configured to be advanced in the body of the patient in a compacted configuration, also referred to as an unexpanded configuration. In the compacted configuration, the vessel liner 130 has a relatively small cross-sectional size compared to, for example, the introducer sheath member 108 and medical devices delivered to the patient via the introducer sheath member 108. In some embodiments, in particular for femoral access applications, the vessel liner 130 has a maximum cross-sectional width, for example, a diameter for a liner 130 that is tubular in shape, in the unexpanded configuration in a range of about 1 mm (3 Fr) to about 3mm (9 Fr), more specifically a range of about 1 ,3mm (4 Fr) to about 2.6mm (8 Fr), even more specifically a range of about 1 ,7mm (5 Fr) to about 2.3mm (7 Fr), and even more specifically about 1 .7 mm (5 Fr) or about 2mm (6 Fr). In some embodiments, the maximum cross-sectional width of the vessel liner 130 in the unexpanded configuration is less than 4mm (12 Fr), less than 3.3mm (10 Fr), less than 2.7mm (8 Fr), less than 2mm (6 Fr), or less than 1 ,7mm (5 Fr). In some embodiments, in particular for radial access applications, the maximum cross- sectional width of the vessel liner 130, for example, a diameter for a liner 130 that is tubular in shape, in the unexpanded configuration is about 1 mm (3 Fr). The relatively small size of the vessel liner 130 in the unexpanded configuration, together with other features of the vessel liner 130, such as a relatively low bending stiffness, facilitate advancing the introducer system 100 in the body of the patient in a manner that poses little or no risk of trauma.

[0078] When the vessel liner 130 is appropriately positioned in the body of the patient (for example, when the distal end of the vessel liner 130 is positioned at or near a target location for delivery of a medical device), the vessel liner 130 is reconfigured to an enlarged configuration, also referred to as an expanded configuration. In some embodiments, the vessel liner 130 is reconfigured to the expanded configuration by internally receiving a relatively large expander, such as a portion of the introducer sheath assembly 102 (FIGS. 1 and 2), more specifically the dilator 112 and / or the introducer sheath member 108, and / or any of the other expanders contemplated herein.By surrounding the introducer sheath member 108, the vessel liner 130 protects tissue when the introducer sheath member 108 is advanced in the body of the patient.

[0079] In some embodiments, the vessel liner 130 expands from a maximum cross- sectional width in the unexpanded configuration to a maximum cross-sectional width in the expanded configuration by a factor (hereinafter, the vessel liner 130 more concisely described as having an “expansion factor”) of at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, at least ten, or more. In some embodiments, the vessel liner is configured to expand from the compacted configuration to the expanded configuration by an increase of a factor of at least 0.5.

[0080] The vessel liner 130 may generally be constructed of a film, laminate, or other material that is pliable and provides sufficient strength to resist abrasion or punctures during insertion, removal, movement, or articulation of components in the vessel liner 130. Other material properties of the vessel liner 130 may include one or more of drapability, conformability, low bending stiffness, and lubriciousness. The vessel liner 130 may be constructed with a single layer or multiple layers. In certain embodiments, the vessel liner 130 may generally be constructed of one or more elastic materials (that is, materials having a low durometer or low modulus of elasticity), more specifically silicone, polyurethane (PU), such as Tecothane®, rubber, latex, and the like. In some embodiments, the vessel liner 130 may be constructed of one or more relatively inelastic materials, for example expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), polypropylene, polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyester, and the like, and the liner 130 may include one or more structural features that facilitate expandability. Examples of such features are described in further detail below. In certain embodiments, the vessel liner 130 may be constructed of one or more composite materials, such as those described in U.S. Pat. No. 10,279,084, the disclosure of which is hereby incorporated by reference. The vessel liner 130, 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. Such modifications may include, for example, providing internal and / or external coatings to the liner 130, such as hydrophobic coatings, hydrophilic coatings, other frictionmodifying coatings, or any of those described herein in connection with the introducer sheath member 108.

[0081] With continued reference to FIGS. 1 and 3, the vessel liner 130 includes a liner lumen 132 (FIG. 3) that may initially receive the guidewire 106 (shown separated inFIG. 1) and subsequently receives the expander, more specifically the dilator 112 and / or the introducer sheath member 108. The guidewire 106 may also initially extend outwardly from a distal opening 134 of the liner lumen 132. That is, the liner lumen 132 receives the guidewire 106 when the vessel liner 130 is being positioned in the body of the patient. In some embodiments, the vessel liner 130 is advanced along the guidewire 106 when the vessel liner 130 is being positioned in the body of the patient. In other embodiments, the vessel liner 130 is fixedly coupled to the guidewire 106, for example, at the distal opening 134 of the vessel liner 130, and the guidewire 106 and the vessel liner 130 are together advanced in the body of the patient.

[0082] With continued reference to FIGS. 1 and 3, the vessel liner assembly 104 further includes a liner hub 136 coupled to the vessel liner 130. In use, the hub 136 remains outside of the body of the patient. The hub 136 includes distal hub portion 138 and a proximal hub portion 140 that together define a hub lumen 142 (FIG. 3) coupled to the liner lumen 132. The hub lumen 142 ends at an access opening 144 of the vessel liner assembly 104 into which the introducer sheath assembly 102 is advanced. In some embodiments and as illustrated, the hub 136 couples to one or more fluid ports for selectively delivering or removing one or more fluids from the hub lumen 142 and thereby the liner lumen 132. Illustratively, the vessel liner assembly 104 includes a flush port 146, a valve port 148, and a side port 150.

[0083] In certain embodiments, the vessel liner assembly 104 includes a hemostasis valve (not shown), which may be operable as a stand-alone component or together with the introducer sheath assembly 102. Such a hemostasis valve could include features for securing to a hemostasis valve of another device, such as the introducer sheath assembly 102. In some embodiments, the hemostasis valve could have a relatively simple structure, such as that of a silicone hemostasis valve. In certain embodiments, the hemostasis valve could include an o-ring or gasket seal operable together with the introducer sheath assembly 102.

[0084] FIGS. 4A and 5 further illustrate the vessel liner 130. More specifically, FIG. 4A is a cross-sectional view of the vessel liner 130 in the compacted configuration, and FIG. 5 is a cross-sectional view of the vessel liner 130 in the expanded configuration. As described briefly above, for example in embodiments in which the vessel liner 130 is constructed of one or more relatively inelastic materials, the liner 130 may include one or more structural features that facilitate expansion from the compacted configuration to the expanded configuration. Such features may include, for example, one or morepleats or folds 152 (FIG. 4A). Portions of the folds 152 overlap in the compacted configuration (FIG. 4A), thereby providing the vessel liner 130 with a relatively small cross-sectional size in the compacted configuration. In contrast, portions of the folds 152 do not overlap in the expanded configuration (and therefore are not shown in FIG. 5), or overlap to a lesser extent in the expanded configuration, thereby providing the vessel liner 130 with a relatively large cross-sectional size in the expanded configuration. In certain embodiments and as described in further detail below, the folds 152 are arranged in a pattern, such as a bi-directional pattern, more specifically an overlapping bi-directional pattern providing a five-layer pleat. In some embodiments, the folds 152 facilitate relatively low frictional forces between the vessel liner 130 and the vessel during insertion and / or expansion, relatively low frictional forces between vessel liner 130 and introducer sheath member 108, and / or relatively low forces for expanding, or minimal "rebound" or retraction force leading to minimal friction on the sheath member 108.

[0085] In some embodiments, the folds 152 are formed by holding the vessel liner 130 in the compacted configuration and heating the liner 130, for example, to a temperature below (for example, near, but below) the melting temperature of the material from which the liner 130 is constructed. In certain embodiments, such heating causes portions of the folds 152 to adhere to each other. In some embodiments, the folds 152 are formed by crushing the liner 130, resulting in an unorganized arrangement of folds 152. In other embodiments, the liner 130 includes an organized arrangement of folds 152. In some embodiments, the folds 152 are formed using porous material (that is, a plurality of holes through a film or a film that allows fluid transport therethrough, both cases facilitating fluid management around the vessel liner 130).

[0086] In other embodiments, the liner 130 lacks structural features that facilitate expansion and is instead reconfigurable from the compacted configuration to the expanded configuration by being constructed of an elastic material. In either case, in some embodiments the vessel liner 130 remains in the compacted configuration when externally unconstrained and until an expander is advanced in the lumen 132 of the liner 130. In other embodiments, a constraining device or system initially holds the vessel liner 130 in the compacted configuration.

[0087] With continued reference to FIGS. 4A and 5, in some embodiments the vessel liner 130 includes one or more elements for stiffening the liner 130 in its longitudinal direction, also referred to as longitudinal stiffening elements, to facilitateinserting and removing the liner 130 from the body of the patient. Illustratively, the folds 152 may act as longitudinal stiffening elements. Additionally or alternatively, one or more wires 154 carried by a flexible body 156 of the liner 130 may act as longitudinal stiffening elements. The wires 154 may be constructed of one or more relatively stiff materials, including relatively stiff polymers, for example PE, ePE, LDPE, PEEK, or polyimide, or metals such as stainless steel or nitinol, and the flexible body 156 may be constructed of, for example, any of the elastic or inelastic materials contemplated herein. Additionally or alternatively, the longitudinal stiffening elements may include internal fluid channels formed in the liner 130. In various embodiments, the vessel liner 130 may have a longitudinal column strength sufficient to facilitate percutaneous delivery without using any separate reinforcement members. More specifically, the vessel liner 130 may have a longitudinal column strength sufficient to prevent or substantially inhibit unwanted crumpling or collapse in the compacted configuration and during advancement within a vessel, while still being sufficient flexible to track the tortuous vascular anatomy without significant damage to the anatomy. In some embodiments, sufficient longitudinal column strength is defined by the ability of the liner 130 to maintain at least about 80%, 85%, 90%, 95%, or 99% of its original longitudinal length, or any other range or value therebetween, in response to an applied force representative of operating conditions. Additionally or alternatively, the liner 130 may include a helical wrap structure that inhibits splitting and / or improves radial strength and durability.

[0088] The vessel liner 130 may be provided with various types of fold patterns, including, as illustrated in FIG. 4A, a unidirectional fold pattern. In some embodiments and as illustrated in FIGS. 4B-4D, the vessel liner 130 may have bidirectional fold pattern, for example a three-layer bidirectional fold pattern (FIGS. 4B and 4D) or a five- layer bidirectional fold pattern (FIG. 4C). In certain embodiments, bidirectional fold patterns advantageously reduce twist build-up during unfolding. In some embodiments, a five-layer bidirectional fold pattern is advantageously relatively efficient, more specifically by reducing the diameter by a factor of about five. In other embodiments, the vessel liner 130 lacks a fold pattern.

[0089] In some embodiments, the vessel liner 130 includes one or more radiopaque features to facilitate visualization under medical imaging. For example, the vessel liner 130 may include discrete radiopaque features or radiopaque material-imbibed polymers at the distal tip or along the length of the liner 130. As a specific example, thelongitudinal stiffening elements, particularly the wires 154 may be constructed of a radiopaque material.

[0090] FIGS. 6-8 are schematic side views of the introducer sheath assembly 102 and the vessel liner assembly 104 being implemented to deliver a medical device 158 to the body of patient, more specifically a vessel V of the body of the patient. More specifically, FIG. 6 illustrates the introducer sheath assembly 102 prior to insertion into the vessel liner assembly 104, FIG. 7 illustrates the introducer sheath assembly 102 being inserted into the vessel liner assembly 104, and FIG. 8 illustrates the introducer sheath assembly 102 and the medical device 158 after being inserted into the vessel liner assembly 104.

[0091] As illustrated in FIG. 6, the vessel liner 130, in its compacted configuration, is first positioned in the body of the patient, more specifically a vessel V of the patient. The introducer sheath member 108 and the dilator 112 are positioned proximally relative to the access opening 144 of the liner hub 136.

[0092] As illustrated in FIG. 7, the introducer sheath member 108 and the dilator 112 are then advanced toward the vessel liner assembly 104 and extend through the access opening 144 of the liner assembly 104 and into the liner lumen 132. The dilator 112 contacts and expands the vessel liner 130, or reconfigures the vessel liner 130 to the expanded configuration. The sheath member 108 contacts the vessel liner 130 and maintains the vessel liner 130 to the expanded configuration. The dilator 112 and the introducer sheath member 108 may be advanced until the distal opening 114 of the sheath member 108 is positioned distally relative to the distal opening 134 of the vessel liner 130, proximally relative to the distal opening 134 of the vessel liner 130, or even with the distal opening 134 of the vessel liner 130. The vessel liner 130, by being positioned between vessel V and the dilator 112 and the introducer sheath member 108, can reduce or limit shear forces and / or tensile forces applied by the dilator 112 and the introducer sheath member 108 to the surrounding tissue. Instead, such forces are applied to the vessel liner 130, and the liner hub 136 acts as an anchor to maintain the position of the vessel liner 130 relative to the vessel V.

[0093] As illustrated in FIG. 8, the dilator 112 is then withdrawn and removed from the sheath lumen 110 (and therefore absent in FIG. 8). The medical device 158 is then advanced through the access opening 120 of the sheath lumen 110, the hub lumen 118, the sheath lumen 110, and the distal opening 114 and thereby delivered to the vessel V.

[0094] In certain embodiments, the vessel liner assembly 104 includes one or more additional or alternative features that facilitate advancing the vessel liner 130 in the body of the patient in a manner that poses little or no risk of trauma. For example and referring to FIG. 9, in some embodiments the vessel liner 130 includes a tapered distal tip 160, adjacent the distal opening 134 of the vessel liner 130, that provides a relatively small step-up in size from a delivery wire 162 (for example, the guidewire 106 or a dedicated liner delivery wire). The tapered distal tip 160 may be provided by the structure of the liner 130 itself and / or a separate first constrainer 164. For example, in certain embodiments the tapered distal tip 160 is formed by pleats or folds in the liner 130, similar to the adhered folds 152 described hereinabove, or by rolling the liner 130 adjacent the distal opening 134 of the vessel liner 130. As another example, in some embodiments the constrainer 164 is a wrap or ring surrounding the pleats or folds of the liner 130. In certain embodiments, the constrainer 164 is constructed of one or more elastic materials to facilitate expanding the vessel liner 130. In some embodiments, the constrainer 164 is plastically deformable or tearable to facilitate removal before expanding the vessel liner 130. In certain embodiments, particularly those in which the delivery wire 162 is a dedicated liner delivery wire, the liner 130 is initially fixedly coupled (for example, via adhesion) at the tapered distal tip 160 to the delivery wire 162, and the vessel liner 130 subsequently detaches from the delivery wire 162 (for example, upon expansion of the liner 130 or receiving a fluid via one of the ports 146, 148).

[0095] As another example and referring to FIG. 10, in some embodiments the vessel liner 130 is advanced in the vessel of the patient together with a dedicated liner dilator 166. In some embodiments, the vessel liner 130 and the liner dilator 166 are together advanced along the delivery wire 162 (shown elsewhere). The dilator 166 may be a flexible, elongated component which, in some embodiments, has an outer diameter sized to provide the vessel liner 130 with one of the unexpanded maximum cross- sectional widths described hereinabove. The dilator 166 includes a tapered distal tip 168. Additionally, the vessel liner 130 includes a tapered distal tip (not shown) and / or a second constrainer 170 that provides a relatively small step-up in size from the delivery wire 162. In certain embodiments, the constrainer 170 is a flexible skirt positioned near the tip of the liner dilator 166 and surrounding the distal edge of the liner 130. The dilator 166 is advanced distally relative to the liner 130 to disengage the skirt and uncover the edge of the liner 130, and the dilator 166 and the skirt are then withdrawnthrough the liner lumen 132. In some embodiments, the constrainer 170 is a tear-away skirt adhered to both the edge of the liner 130 and the liner dilator 166. Such a skirt may be constructed of, for example, ePE. In some embodiments, the constrainer 170 is a constraining loop fiber surrounding and constraining the edge of the liner 130 the dilator 166. In certain embodiments, the constrainer 170 is a zipper deployment system that surrounds the edge of the liner 130 or the entire liner 130. In some embodiments, the constrainer 170 is a pre-split constraining tube that is proximally withdrawable. In certain embodiments, the constrainer 170 is an elastomeric ring positioned in the edge of the liner 130. In some embodiments, the constrainer 170 is a tube that is proximally withdrawable and splitable. More specifically, the tube may be split by a blade, or withdrawal may cause a tear to propagate along the tube. In some embodiments, the constrainer 170 may be a stent-like structure positioned in the edge of the liner 130. Such a structure may have an unconstrained diameter equal to or slightly less than the diameter of the liner dilator 166, and the structure may be dilated after the dilator 166 is withdrawn and an expander expands the vessel liner 130. In certain embodiments, the liner dilator 166 has a smaller cross-sectional size proximal to the tapered distal tip 168, which facilitates providing the vessel liner 130 with a “step-down” in cross sectional size.

[0096] In some embodiments and as described above, the introducer sheath assembly 102 acts as an expander for reconfiguring the vessel liner 130 from the compacted configuration to the expanded configuration. In some embodiments, other devices, components, or materials may alternatively or additionally act as expanders for reconfiguring the vessel liner 130 from the compacted configuration to the expanded configuration. For example, the medical device 158, more specifically an endoluminal device deployment system, the sheath dilator 112, and / or a fluid received via one of the ports 146, 148 may act as expanders. In some embodiments, such devices and components may be used without using the introducer sheath member 108 as an expander. In such embodiments, the introducer system 100 advantageously facilitates localized cross-sectional size increases adjacent the medical device. In such embodiments, the introducer system 100 has a relatively small wall thickness and cross sectional area, thereby reducing the risk of ischemia and other potential complications. In some embodiments, a catheter-mounted therapeutic endoprosthesis device, a diagnostic device, or a monitoring device act as an expander for reconfiguring the vessel liner 130 from the compacted configuration to the expanded configuration. In some embodiments, the working length of the vessel liner 130 exceeds the workinglength of the introducer sheath assembly 102 to facilitate advancing a therapeutic device, a diagnostic device, or a monitoring device in locations that are not easily accessible by the introducer sheath assembly 102.

[0097] In some embodiments, the dedicated delivery wire 162 and the liner dilator 166 act as advancers to which the vessel liner 130 is initially coupled, and the advancers are movable in the vessel of the patient to move the vessel liner 130 in the vessel of the patient. In some embodiments, other devices or components may alternatively or additionally act as advancers for moving the vessel liner 130 in the vessel of the patient. For example, a catheter with a relatively small cross-sectional size (not shown) may act as an advancer, and the liner 130 may be coupled to the catheter by a locking line or wire. In other embodiments, the vessel liner 130 is movable in the vessel of the patient without using an advancer.

[0098] FIGS. 11-14 are side views of the introducer sheath assembly 102 and the vessel liner assembly 104 being implemented to deliver a medical device (shown elsewhere) to the body of patient, more specifically a vessel V of the body of the patient

[0099] As illustrated in FIG. 11 , the delivery wire 162 enters the vessel V of the patient via puncture site P, and the vessel liner 130, in its compacted configuration, is advanced toward the vessel V. In certain embodiments, the delivery wire 162 is the guidewire 106, which facilitates delivering the medical device to a target location in the body of the patient, and the vessel liner 130 is advanced along the guidewire 106. In some of these embodiments and others, the vessel liner 130 is advanced in the vessel V without using any separate reinforcement members. Relatedly, in some embodiments the vessel liner 130 has sufficient buckling strength in the compacted configuration to inhibit collapse while advancing in the vessel V of the patient. In some embodiments, the delivery wire 162 is a dedicated wire to which the vessel liner 130 is initially fixedly coupled, and the delivery wire 162 and the vessel liner 130 are together advanced in the vessel V of the patient.[000100] After the vessel liner 130 is positioned in the vessel V of the patient, as illustrated in FIG. 12, the introducer sheath member 108 and the sheath dilator 112 are then advanced toward the access opening 144 of the vessel liner assembly 104. In some embodiments, the introducer sheath member 108 and the sheath dilator 112 are advanced along the guidewire 106.[000101 ] The introducer sheath member 108 and the sheath dilator 112 are then advanced and extend through the access opening 144 of the liner assembly 104 andinto the liner lumen 132 (shown elsewhere). As illustrated in FIG. 13, this action expands the vessel liner 130, or reconfigures the vessel liner 130 to the expanded configuration. The vessel liner 130, by being positioned between vessel V and the dilator 112 and the introducer sheath member 108 (both shown elsewhere), can reduce or limit shear forces and / or tensile forces applied by the dilator 112 and the introducer sheath member 108 to the surrounding tissue. Instead, such forces are applied to the vessel liner 130, and the liner hub 136 acts as an anchor to maintain the position of the vessel liner 130 relative to the vessel V. In some embodiments, the introducer hub 116 is then secured to the liner hub 136. The sheath dilator 112 (shown elsewhere) is then withdrawn from the introducer sheath member 108. The medical device (shown elsewhere) is then advanced through the introducer sheath assembly 102, the vessel liner assembly 104, and the vessel until reaching the target location. In some embodiments, a portion of the medical device (for example, a stent) subsequently remains positioned at the target location and another portion of the medical device (for example, a delivery catheter) is withdrawn from the introducer sheath assembly 102, the vessel liner assembly 104, and the vessel V.[000102] In some embodiments, a fluid is then delivered to the liner lumen 132 (shown elsewhere), for example, via one of the ports 146, 148, to facilitate separating the introducer sheath member 108 from the vessel liner 130 (for example, by inflating the liner 130 or lubricating the interface between the liner 130 and the sheath member 108). In some embodiments, the vessel liner 130 includes a seal (not shown) at its distal end to facilitate inflation and / or distribution of the fluid. In some embodiments, the liner 130 may have variable radial stiffness (such as a wrap angle gradient on an elastomeric film) to facilitate continuously sealing around the distal end of the sheath member 108 during subsequent withdrawal.[000103] As illustrated in FIG. 14, the introducer sheath member 108 is then withdrawn from the vessel liner assembly 104. In some embodiments, withdrawing the introducer sheath member 108 from the vessel liner assembly 104 causes the vessel liner 130 to at least partially collapse, or fully collapse to the compacted configuration. Additionally or alternatively, the vessel liner 130 may be at least partially collapsed by twisting and / or applying a vacuum to the liner 130. The vessel liner 130 is then withdrawn from the vessel V and the puncture site P. Such a sequence may mitigate tissue trauma caused during removal of the introducer sheath assembly 102 and the vessel liner assembly 104 from the patient.[000104] In some embodiments, the expandability and conformability of the vessel liner 130 may facilitate vessel preparation treatments to enlarge the diameter of the vessel with the liner 130 in place and through the liner 130, which may result in less shear force against the vessel wall and fewer insertions.[000105] In some embodiments, the vessel liner assembly 104 may act as a diagnostic sheath to facilitate creation of a procedural path, and the vessel liner 130 is subsequently expanded when the procedure begins.[000106] In certain embodiments, the introducer system 100 may provide one or more of the following advantages: reduced or limited shear forces and / or tensile forces applied to surrounding tissue during insertion and / or removal of the introducer sheath member 108; reduced or limited frictional forces between the vessel liner 130 and the vessel during insertion and / or expansion, for example, a reduced number of contact cycles experienced by the vessel to a single insertion of the liner 130, and then multiple insertions / withdrawals of other devices within the liner 130; facilitates use of compliance modification treatments, such as intravascular lithotripsy ( “I VL”) , balloon angioplasty, and serial dilator advancements.[000107] In some embodiments, particularly those in which the vessel liner 130 extends further distally, or is longer, than the sheath member 108, the introducer system 100 may provide one or more of the following advantages: particular suitability for delivery of therapeutic, catheter-mounted stent grafts beyond the distal tip of the sheath member 108; protecting previously-delivered stent grafts during advancement of additional therapeutic, catheter-mounted stent grafts beyond the distal tip of the sheath member 108; protecting vessels during advancement of therapeutic, catheter-mounted stent grafts beyond the distal tip of the sheath member 108; protecting vessels in target areas that are difficult to reach with the sheath member 108; protecting vessels when a relatively long sheath member 108 is not available; providing protection when a medical device is advanced in a chamber of the heart; retracting the vessel liner 130 through the sheath member 108 prior to deployment.[000108] In some embodiments in which the vessel liner 130 extends further distally, or is longer, than the sheath member 108, a pre-defined distal section 172 of the vessel liner 130 may be detached and reconfigured to its expanded configuration by expansion or deployment of a stent or a stent graft. In the expanded configuration, the detachable distal section 172 of the vessel liner 130 may have a wider diameter than the remainder of the vessel liner 130, and the detachable distal section 172 may accommodate theexpanded diameter of the stent or stent graft. After separation from the remainder of the vessel liner 130, the expanded distal section 172 remains in the vessel between the vessel wall and the stent or stent graft, and the distal section 172 may thereby provide added vessel wall protection and enable delivery of lower profile stents or stent grafts. [000109] In certain embodiments, vessel liner assemblies according to the present disclosure include at least two adjacent unexpanded lumens made of one or more materials. FIGS. 15 and 16 illustrate an example of such dual lumen vessel liner 200. The two or more vessel liner lumens 202, 204 of the liner 200 run parallel to each other and allow the simultaneous or sequential introduction of medical devices in separate conduits. When the liner 200 is reconfigured to its enlarged (expanded) configuration, the first vessel liner lumen 202 accommodates the passage of a first medical device 206 (for example, an introducer sheath assembly 102, an introducer sheath member 108, an endoluminal deployment system, a surgical device, or the like). While appropriately positioned in the body of the patient, the second vessel liner lumen 204 remains configured in its unexpanded configuration. The second vessel liner lumen 204 is then used to accommodate the passage of another medical device (not shown - for example a monitoring device, and endoluminal imaging system, a stent or stent graft, an introducer sheath assembly 102, or the like).[000110] 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

CLAIMSWHAT IS CLAIMED IS:1 . An introducer system comprising: a vessel liner defining a liner lumen, and the vessel liner being expandable from a compacted configuration to an expanded configuration in a vessel; a liner hub coupled to the vessel liner; and an expander removably positionable into the liner lumen of the vessel liner to cause the vessel liner to reconfigure from the compacted configuration to the expanded configuration in the vessel.

2. The introducer system of claim 1 , wherein the expander comprises an introducer sheath assembly, the introducer sheath assembly defining a sheath lumen configured to receive and deliver a medical device.

3. The introducer system of claim 1 , wherein the expander comprises an endoluminal device deployment system.

4. The introducer system of claim 1 , wherein the expander comprises a dilator.

5. The introducer system of any of claims 1-4, wherein the vessel liner comprises expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), polyetheretherketone (PEEK), or polyurethane (PU).

6. The introducer system of any of claims 1-5, wherein the vessel liner is configured to remain in the compacted configuration when externally unconstrained and until the expander is advanced in the liner lumen of the vessel liner.

7. The introducer system of any of claims 1-6, further comprising an advancer to which the vessel liner is coupled, the advancer being movable in the vessel to move the vessel liner in the vessel.

8. The introducer system of any of claims 1-7, wherein the vessel liner is constrained adjacent to a distal tip.

9. The introducer system of any of claims 1-8, wherein the vessel liner is configured to expand from the compacted configuration to the expanded configuration by an expansion factor of at least two.

10. The introducer system of any of claims 1-8, wherein the vessel liner is configured to expand from the compacted configuration to the expanded configuration by an expansion factor of at least 0.5.

11. An introducer sheath system comprising: an expandable vessel liner defining a first lumen; a liner hub coupled to the expandable vessel liner, the liner hub defining an access opening coupled to the first lumen; and a sheath member removably positionable through the access opening of the liner hub and the first lumen of the expandable vessel liner to maintain the expandable vessel liner in an expanded configuration, the sheath member defining a second lumen configured to receive and deliver a medical device.

12. The introducer sheath system of claim 11 , further comprising a sheath dilator removably positionable in the second lumen of the sheath member and the first lumen of the expandable vessel liner to expand the expandable vessel liner to the expanded configuration.

13. The introducer sheath system of claim 12, wherein the sheath dilator comprises a tapered distal tip.

14. The introducer sheath system of any of claims 11-13, further comprising a liner dilator removably positionable in the first lumen of the expandable vessel liner.

15. The introducer sheath system of claim 14, wherein the liner dilator comprises a tapered distal tip.

16. The introducer sheath system of any of claims 11-15, further comprising a fluid port coupled to the expandable vessel liner.

17. The introducer sheath system of any of claims 11-16, wherein the expandable vessel liner comprises a tapered distal tip.

18. The introducer sheath system of any of claims 11-17, wherein the expandable vessel liner comprises a plurality of longitudinal stiffening elements.

19. The introducer sheath system of claim 18, wherein the plurality of longitudinal stiffening elements comprise folds.

20. The introducer sheath system of claim 18, wherein the longitudinal stiffening elements comprise wires and the expandable vessel liner further comprises a flexible body carried by the wires.21 . The introducer sheath system of any of claims 11-20, wherein the expandable vessel liner comprises a longitudinal column strength sufficient to facilitate percutaneous delivery without using any separate reinforcement members.

22. A method of using an introducer sheath system, the introducer sheath system comprising a vessel liner including a first lumen and an introducer sheath member including a second lumen, the method comprising: advancing the vessel liner in a compacted configuration in a vessel; subsequently expanding the vessel liner to an expanded configuration in the vessel; advancing the introducer sheath member in the first lumen of the vessel liner and thereby advancing the introducer sheath member in the vessel; and advancing a medical device in the second lumen of the introducer sheath member and thereby advancing the medical device in the vessel.

23. The method of claim 22, wherein the medical device is an endoluminal device deployment system.

24. The method of any of claims 22-23, wherein advancing the introducer sheath member in the first lumen of the vessel liner causes the expanding of the vessel liner to the expanded configuration in the vessel.

25. The method of any of claims 22-24, wherein the introducer sheath system further comprises a dilator, and advancing the introducer sheath member in the first lumen of the vessel liner comprises advancing the introducer sheath member with the dilator positioned in the second lumen of the introducer sheath member.

26. The method of any of claims 22-25, wherein advancing the vessel liner in the compacted configuration in the vessel comprises advancing an advancer to which the vessel liner is coupled in the vessel.

27. The method of any of claims 22-26, further comprising advancing a guidewire in the vessel before advancing the introducer sheath member in the vessel.

28. The method of claim 27, wherein advancing the vessel liner in the compacted configuration in the vessel comprises advancing the vessel liner along the guidewire in the vessel.

29. The method of any of claims 24-28, wherein the vessel liner remains in the compacted configuration when externally unconstrained and until the introducer sheath member is advanced in the first lumen of the vessel liner.

30. The method of any of claims 22-29, wherein advancing the vessel liner in the compacted configuration in the vessel comprises advancing the vessel liner without using any separate reinforcement members.31 . The method of any of claims 22-30, wherein the vessel liner has sufficient buckling strength in the compacted configuration to inhibit collapse while advancing the vessel liner in the vessel.

32. The method of any of claims 22-31 , wherein the introducer sheath system further comprises a hub coupled to the vessel liner, the hub comprising an access opening coupled to the first lumen of the vessel liner, and advancing the introducer sheath member in the first lumen of the vessel liner comprises advancing the introducer sheath member through the access opening of the hub.

33. The method of any of claims 22-32, further comprising removing the medical device from the second lumen of the introducer sheath member and thereby removing the medical device from the vessel.

34. The method of claim 33, further comprising, after removing the medical device from the vessel, removing the introducer sheath member and the vessel liner from the vessel.

35. The method of claim 34, wherein removing the introducer sheath member and the vessel liner from the vessel comprises removing the introducer sheath member from the vessel and subsequently removing the vessel liner from the vessel.

36. The method of any of claims 34-35, further comprising at least partially collapsing the vessel liner before removing the vessel liner from the vessel.

37. The method of any of claims 22-36, further comprising delivering a fluid to the first lumen and between the vessel liner and the introducer sheath member.

38. The method of any of claims 22-36, wherein expanding the vessel liner to the expanded configuration in the vessel includes delivering a fluid to the first lumen of the vessel liner.

39. The method of claim 38, wherein delivering the fluid to the first lumen of the vessel liner includes delivering the fluid between the vessel liner and a guidewire within the first lumen of the vessel liner.

Images