Patent Publication Number: US-2021162170-A1

Title: Expandable sheath

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 15/875,706, filed Jan. 19, 2018, which claims the benefit of priority to U.S. Provisional Application No. 62/449,454, filed Jan. 23, 2017. Each of the aforementioned applications is incorporated by reference in its entirety for all purposes. 
    
    
     FIELD 
     The present application is directed to a sheath for use with catheter-based technologies for repairing and/or replacing heart valves, as well as for delivering an implant, such as a prosthetic valve to a heart via the patient&#39;s vasculature. 
     BACKGROUND 
     Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as a prosthetic heart valve, at locations inside the body that are not readily accessible by surgery or where less invasive surgery is desirable. For example, aortic, mitral, tricuspid, and/or pulmonary prosthetic valves can be delivered to a treatment site using minimally invasive surgical techniques, including transcatheter delivery methods. 
     An introducer sheath can be used to safely introduce a delivery apparatus into a patient&#39;s vasculature (e.g., the femoral artery). An introducer sheath generally has an elongated sleeve that is inserted into the vasculature and a housing that contains one or more sealing valves that allow a delivery apparatus to be placed in fluid communication with the vasculature with minimal blood loss. A conventional introducer sheath typically requires a tubular loader to be inserted through the seals in the housing to provide an unobstructed path through the housing for the prosthetic implant, such as a heart valve mounted on a balloon catheter. A conventional loader extends from the proximal end of the introducer sheath, and therefore decreases the available working length of the delivery apparatus that can be inserted through the sheath and into the body. 
     Conventional methods of accessing a vessel, such as a femoral artery, prior to introducing the delivery system include dilating the vessel using multiple dilators or sheaths that progressively increase in diameter. This repeated insertion and vessel dilation can increase the amount of time the procedure takes, as well as the risk of damage to the vessel. 
     Radially expanding intravascular sheaths reduce the overall profile of the sheath to reduce risk of damage to the vessel. Such sheaths tend to have complex mechanisms, such as ratcheting mechanisms that maintain the shaft or sheath in an expanded configuration once a device with a larger diameter than the sheath&#39;s original diameter is introduced. 
     However, delivery and/or removal of prosthetic devices and other material to or from a patient still poses a risk to the patient. Furthermore, accessing the vessel remains a challenge due to the relatively large profile of the delivery system that can cause longitudinal and radial tearing of the vessel during insertion. The delivery system can additionally dislodge calcified plaque within the vessels, posing an additional risk of clots caused by the dislodged plaque. The addition of radially expanding properties can also hinder a practitioner&#39;s ability to push the sheath without it bending or kinking. Thus, there remains a need for further improvements in introducer sheaths for endovascular systems used for implanting heart valves and other prosthetic devices. 
     SUMMARY 
     Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths are adapted to temporarily expand a portion of the sheath to allow for the passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the system. The sheath includes an elongated annular member through which the cardiovascular device and its delivery system pass. The annular member has longitudinally extending channels that facilitate the sheath&#39;s expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of longitudinally extending contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the contact surfaces back towards their original positions after the passage of the device. Methods of making an expandable sheath tip are also included. 
     Disclosed herein are expandable sheaths including an elongated annular member that has an inner and outer surface. The annular member also include a bridge member extending between opposing first and second base members spaced around the circumference of the annular member. The expandable sheath is radially movable between an expanded state and a non-expanded state. In the non-expanded state, the annular member includes a first and second longitudinally extending channel. The first longitudinally extending channel is defined between the bridge member the first base member and extends inwardly from the outer surface of the sheath towards the annular member&#39;s longitudinal axis. The second longitudinally extending channel is defined between the bridge member and the second base member and extends outwardly from the inner surface of the sheath away from the longitudinal axis of the annular member. In the expanded state, the bridge member extends in a direction around the circumference of the annular member increasing a distance between the first and second base members. 
     In some embodiments of the expandable sheath, the expanded diameter of the annular member is greater than the non-expanded diameter of the annular member. 
     In some embodiments of the expandable sheath the orientation of the first and second base members changes when the annular member moves between the expanded and non-expanded state. For example, the orientation of the first and second base members can rotate about a longitudinal axis of each of the respective base members when the annular member is moved between the expanded and non-expanded state. 
     Some embodiments of the expandable sheath include the first and second base members having a contact edge that defines the inner diameter of the annular member in the expanded state. 
     In some embodiments, the bridge member extends in a direction around a circumference of the annular member in the expanded state. For example, the first and second base members can extend in a direction around a circumference of the annular member in the expanded and non-expanded state, and at least a portion of the bridge member can extend in a direction towards the longitudinal axis of annular member in the non-expanded state and around the circumference of the annular member in the expanded state. 
     In some embodiments the first and second base members define a rectilinear shape in cross-section. The bridge member can define an S-shape in cross-section. In some embodiments, the bridge member can define an arcuate shape in cross-section. 
     Some embodiments of the expandable sheath includes an outer layer extending over the annular member, the outer layer can comprise a material having a higher elastic modulus than the annular member and the annular member can comprise a material having greater lubricity than the outer layer. 
     Also disclosed is an expandable sheath including an elongated annular member movable between a non-expanded and expanded state. The annular member includes base members spaced around a circumference of the annular member, and bridge members extending between opposing pairs of base members. In the non-expanded state the annular member includes inwardly and outwardly extending channels that extend towards and away from the longitudinal axis of the annular member, respectively. The inwardly and outwardly extending channels can be defined between the base and bridge members. In the expanded state the diameter of the annular member is increased and a spacing between opposing based members is increased from the non-expanded state diameter and spacing. 
     In some embodiments of the expandable sheath, one inwardly extending channel and one outwardly extending channels is provided at opposing ends of a corresponding one of the bridge members. In some embodiments, in the expanded state the depth of each of the inwardly and outwardly extending channels, in a radial direction, is decreased compared to a depth of each of the channels in the non-expanded state. 
     In some embodiments of the expandable sheath the base members include a first, second and third base member and the bridge members include a first and second bridge member. The first bridge member extends between the first and second base members, and the second bridge member extends between the second and third base members. 
     Also disclosed is a method of making an expandable sheath. The method includes coextruding a tube comprising a first material and a second material. The first material defines the elongated annular member having an outer surface and an inner surface. The first material further defines a first and second set of longitudinally extending channels. The first set of longitudinally extending channels extend inwardly from an outer surface of the elongated member towards the longitudinal axis of the annular member. The second set of longitudinally extending channels extend outwardly from an inner surface of the annular member away from the longitudinal axis. The second material defines a first set of longitudinally extending ribbons extending within the first set of channels and a second set of longitudinally extending ribbons extending within the second set of channels. Each ribbon of a selected set is positioned circumferentially between ribbons of the other set. 
     In some embodiments, the method of making an expandable sheath can further include coextruding a third material in contact with a portion of the first material and a portion of the second material, wherein the third material adheres to both the first material to the second material. The third material can be located between a portion of the first and second material within the first and second set of channels. 
     In some embodiments, the method of making an expandable sheath can further include adding a taper tube to the coextrusion. 
     In some embodiments, the method of making an expandable sheath can further include removing the second material and exposing the first and second set of longitudinally extending channels upon removal of the second sacrificial material. 
     In some embodiments, the method can further include covering the annular member with an outer layer comprising a material having a higher elastic modulus than the annular member. 
     Also disclosed is a method of delivering a cardiovascular prosthetic device. The method includes positioning an expandable sheath at an implantation site within the vascular system of a patient, introducing a prosthetic device into a lumen of the expandable sheath, advancing a cardiovascular prosthetic device through the lumen of the expandable sheath, exerting a radially outward force on an inner surface of the sheath with the cardiovascular prosthetic device, widening longitudinally extending channels provided circumferentially around the inner and outer surfaces of the sheath and moving longitudinally extending contact surfaces toward the inner and outer surfaces of the sheath, thereby expanding a portion of the sheath a a location of the radially outward force. The method further includes at least partially collapsing the expanded portion of the sheath after the device has passed through the expanded portion. In some embodiments, the cardiovascular prosthetic device is a prosthetic heart valve. 
     In some embodiments, the method of delivering a cardiovascular prosthetic device can further include moving the contact surfaces away from the inner and outer surfaces of the annular member after passage of the cardiovascular prosthetic device using an outer layer of the expandable sheath. 
     Also disclosed is a method of making a distal tip of an expandable sheath. The method includes pinching a portion of the distal end of a tube to create a longitudinally extending outer crease, folding the pinched portion over an outer surface of a distal end of the tube in a circumferential direction to create a longitudinally extending flap bounded by the outer crease and a longitudinally extending inner crease, cutting the inner crease of the longitudinally extending flap in a longitudinal direction from the distal edge of the tube to a proximally spaced point along the longitudinal axis of the tube to create a longitudinally extending inner edge, cutting the longitudinally extending flap at the proximally spaced point in a circumferential direction from the outer crease to the longitudinal cut at the inner crease, extending the inner edge of the longitudinally extending flap in a circumferential direction around the outer surface of the distal end of the tube, and adhering the cut inner crease to the outer surface of the distal end of the tube to create the distal tip. Some embodiments of the method further include covering the cut distal end of the tube with an outer jacket and reflowing the tube with the outer jacket to create the sealed distal tip. 
    
    
     
       DESCRIPTION OF DRAWINGS 
       In the drawings, like reference numbers and designations in the various drawings indicate like elements. 
         FIG. 1  is an elevation view of an expandable sheath along with an endovascular delivery system for implanting a prosthetic heart valve. 
         FIG. 2A  shows a cross sectional view of an example expandable sheath in the non-expanded state. 
         FIG. 2B  shows the expandable sheath of  FIG. 2A  in the expanded state. 
         FIG. 3A  shows a cross sectional view of an example expandable sheath in the non-expanded state. 
         FIG. 3B  shows the expandable sheath of  FIG. 3A  in the expanded state. 
         FIG. 4A  shows a cross sectional view of an example expandable sheath in the non-expanded state. 
         FIG. 4B  shows the expandable sheath of  FIG. 4A  in the expanded state. 
         FIG. 5A  shows a cross sectional view of an example expandable sheath in the non-expanded state. 
         FIG. 5B  shows the expandable sheath of  FIG. 5A  in the expanded state. 
         FIG. 6A  shows a cross sectional view of an example an expandable sheath in the non-expanded state. 
         FIG. 6B  shows the expandable sheath of  FIG. 6A  in the expanded state. 
         FIG. 7A  shows a cross sectional view of an example expandable sheath during an intermediate processing step. 
         FIG. 7B  shows the expandable sheath of  FIG. 7A  in a non-expanded state, after removal of a sacrificial material. 
         FIG. 7C  shows the expandable sheath of  FIG. 7B  in the expanded state. 
         FIG. 8  shows a perspective view of an expandable sheath. 
         FIG. 9  shows a method of making a distal tip of an expandable sheath. 
     
    
    
     DETAILED DESCRIPTION 
     The following description of certain examples of the inventive concepts should not be used to limit the scope of the claims. Other examples, features, aspects, embodiments, and advantages will become apparent to those skilled in the art from the following description. As will be realized, the device and/or methods are capable of other different and obvious aspects, all without departing from the spirit of the inventive concepts. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
     For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved. 
     Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. 
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. 
     “Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. 
     Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps. “Exemplary” means “an example of” and is not intended to convey an indication of a preferred or ideal aspect. “Such as” is not used in a restrictive sense, but for explanatory purposes. 
     Disclosed herein are expandable introducer sheaths and methods of making and using the same. As will be described in further detail below, the expandable sheaths  1  are adapted to allow for temporary expansion of a portion of the sheath to accommodate the passage of a delivery system for a cardiovascular device, then return to a non-expanded state, or “recover” after the passage of the delivery system and device. 
       FIG. 1  illustrates a sheath  1  according to the present disclosure in use with a representative delivery apparatus  210  for delivering a prosthetic device  212 , such as a tissue heart valve, to a patient. The apparatus  210  can include a steerable guide catheter  214  (also referred to as a flex catheter), a balloon catheter  216  extending through the guide catheter  214 , and a nose catheter  218  extending through the balloon catheter  216 . The guide catheter  214 , the balloon catheter  216 , and the nose catheter  218  in the illustrated embodiment are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the valve  212  at an implantation site in a patient&#39;s body, as described in detail below. Generally, a sheath  1  is inserted into a vessel, such as the transfemoral vessel, passing through the skin of patient, such that the distal end of the sheath  1  is inserted into the vessel. Sheath  1  can include a hemostasis valve at the opposite, proximal end of the sheath. The delivery apparatus  210  can be inserted into the sheath  1 , and the prosthetic device  212  can then be delivered and implanted within patient. 
     The expandable introducer sheath  1  is adapted to allow for temporary radial expansion of a portion of the sheath to accommodate the passage of a delivery system for a cardiovascular device (e.g., prosthetic heart valve  212 ) and to then return to a non-expanded state after the passage of the delivery system with its prosthetic device. The expandable sheath  1  includes an elongated annular member  10  through which the delivery system and prosthetic heart valve  212  pass. As will be described in more detail below, the annular member  10  of the expandable sheath  1  can include longitudinally extending channels  12 ,  14  that facilitate the sheath&#39;s expansion for passage of the prosthetic heart valve  212 . The channels  12 ,  14  are positioned such that upon expansion of the annular member  10  certain contact surfaces  22 ,  24  are brought into contact with adjacent surfaces of the delivery apparatus  210 , thereby reducing friction between the annular member  10  and the passing structure. In some embodiments, the radial expansion of the expandable annular member  10  at any given portion along its length is due to the ability of base  20  and/or bridge members  30  of the annular member  10  to rotate. The rotation of these sections reduces the surface/contact area of the annular member  10  thereby reducing friction with the passing structure. The expandable sheath  1  can include an elastic outer layer  50 . In some embodiments, the outer layer  50  can compress the annular member  10  towards a non-expanded configuration. 
       FIGS. 2A and 2B  show a cross-section of an example expandable sheath  1  in an expanded ( FIG. 2A ) and a non-expanded ( FIG. 2B ) state. The non-expanded sheath  1  includes an inner annular member  10  and an outer layer  50 . The outer layer  50  can be constructed from an elastic material that allows for temporary radial expansion of a portion of the outer layer  50  corresponding to the temporary radial expansion of the annular member  10  to accommodate the passage of the delivery system for a cardiovascular device (e.g., prosthetic heart valve  212 ). After passage of the delivery system with its prosthetic device, the annular member  10  and outer layer  50  return to a non-expanded state ( FIG. 2B ). As illustrated in  FIG. 2A , the annular member  10  includes a plurality of base members  20  arranged around the circumference of the annular member  10  and bridge members  30  extending between opposing pairs of base members  20  (e.g., base member  20   a  and base member  20   b ). As illustrated in  FIG. 2A , the base members  20  can define a rectilinear shape in cross-section. The base members  20  can include an outer edge that define the outer surface/diameter  16  of the annular member  10  and an inner edge that define the inner surface/diameter  18 . Base members  20  can include side walls  15  that extend radially between the inner and outer edges. As illustrated in  FIG. 2A , the outer edge has a longer length (around the circumference of the annular member  10 ) than the inner edge. The side walls  15  can meet the inner and outer edges at a curve (illustrated) or angle. The side walls  15  can terminate at the bridge member  30 . As provided in  FIG. 2A , the side walls  15  can meet the bridge members  30  at a curve. In other example annular members  10  (see e.g.,  FIG. 6A ) the side wall of the base member  20  can meet the bridge member  30  at a straight or angled edge/joint. It is further contemplated that the base members  20  can define any regular or irregular shape in cross-section including, for example, square, rectangle, trapezoidal, circular, and oval. Likewise, bridge members  30  can define any regular or irregular shape. As provided in  FIG. 2A , in the unexpanded state the bridge members  30  define a generally S-shape cross-section. That is, in cross-section, the bridge members  30  of  FIG. 2A  can include a relatively (radially) elongate shape that extends between bends (at joints  32 ) where the bridge member  30  couples to the adjacent base member  20 . The bends bracket the ends of the elongate portion and serve as the connection to either the radially inward corner or radially outward corner of adjacent base members. The elongate portion of the bridge member  30  can also widen in the outward radial direction. As will be explained in more detail below, during expansion of the annular member  10  the shape of the base member  20  and/or bridge member  30  changes or otherwise deforms. 
     As illustrated in  FIG. 2A , in the non-expanded state, the annular member  10  includes longitudinally extending channels  12 ,  14 . Inward extending channels  12  extend radially inward from the outer surface/diameter  16  of the annular member  10  towards its longitudinal axis  11 . The inward extending channels  12  are defined between a base member  20  and an adjacent bridge member  30 . The outward extending channels  14  extend radially outward from the inner surface/diameter  18  of the annular member  10  in a radial direction away from the longitudinal axis  11  and are similarly defined between a base member  20  and an adjacent bridge member  30 . 
     The inward and outward extending channels  12 ,  14  alternate in inward versus outward directionality, such that each channel of a selected set/direction is positioned circumferentially between two channels of the other set/direction (i.e., an inward extending channel  12  is position circumferentially between two outward extending channels  14 ). 
     As depicted in  FIG. 2A , the inward and outward extending channels  12 ,  14  extend radially with respect to the longitudinal axis  11  of the annular member  10 . For example, the centerline (c) of each of the inward and outward extending channels  12 ,  14  can create a 90-degree angle (α) with a line tangent to the diameter of the annular member  10  proximate the opening of the channel. 
     The inward and outward extending channels  12 ,  14  extend a certain depth (d) into the wall thickness (t) of the annular member  10 . For example, as illustrated in  FIG. 2A , the inward and outward extending channels  12 ,  14  can have a depth greater than 50% of the wall thickness (t) of the annular member  10 . Though not illustrated, it is contemplated that the depth of the inward and outward extending channels  12 ,  14  can also vary around the annular member  10 . 
     The inward and outward extending channels  12 ,  14  can also define a width (w) measured along the length/depth of the channel. The width (w) can be defined between the sidewall of the corresponding bridge member  30  and base member  20 , i.e., side wall  13  and side wall  15 . As illustrated in  FIG. 2A , the width (w) of each channel can be uniform around the annular member  10 . It is also contemplated that the width (w) of different channels can vary around the annular member  10 . The width (w) of the inward and outward extending channels  12 ,  14  can remain constant (see  FIG. 2A ) or vary along the depth (d) of the channel. 
     The shape of the inward and outward extending channels  12 ,  14  can remain constant or vary around the annular member  10 . As depicted in  FIG. 2A , each of the inward and outward extending channels  12 ,  14  have two substantially parallel and straight sides (defined by side wall  13  and side wall  15 ) that terminate at a rounded end  19 . It is contemplated that the shape of inward and outward extending channels  12 ,  14  can define any regular or irregular shape and that the shape of each inward and outward extending channel  12 ,  14  can vary (or remain constant) around the annular member  10 . 
     In the embodiment shown in  FIG. 2A , the inward and outward extending channels  12 ,  14  are evenly distributed around the circumference of the annular member  10  and are similar in size and shape. While it is contemplated that the size and spacing of the base members  20 , bridge members  30  and corresponding inward and outward extending channels  12 ,  14  can vary, even spacing and uniform size and shape help to prevent tearing of the annular member  10  during expansion. For example, during expansion (shown in  FIG. 2B ) tension is distributed to many points around the circumference of the annular member  10  and not focused at a single location. This distribution of tension reduces the risk of tearing the annular member  10 . 
     As described above, the annular member  10  and elastic outer layer  50  of the sheath  1  are designed to locally expand as the prosthetic device  212  is passed through the interior lumen of the sheath  1  and then substantially return to their original shape once the prosthetic device has passed through that portion of the sheath. That is, in the non-expanded state the outer diameter of the annular member  10  and outer layer  50  can be substantially constant across the length of the sheath  1  from the proximal end  3  to the distal end  5 . As the prosthetic device  212  passes through the interior lumen of the sheath  1 , the portion of the annular member  10  and outer layer  50  proximate the prosthetic device  212  expand radially, with the remaining length/portion of the annular member  10  and outer layer  50  in a substantially non-expanded state. Once the device has passed through a portion of the lumen of the sheath  1 , that portion of the sheath  1  can substantially return to its original shape and size.  FIG. 2B  illustrates the annular member  10  and outer layer  50  in an expanded state. In the expanded state the outer diameters of the annular member  10  and elastic outer layer  50  are greater than the non-expanded diameters of the annular member  10  and outer layer  50 . 
     To achieve expansion, the orientation of the base members  20  and bridge members  30  changes. As illustrated in  FIG. 2B , the base members  20  rotate during expansion of the annular member  10 . For example, the base members  20  rotate with respect to the central axis of each corresponding base member  20 . Similarly, the bridge members  30  rotate and flex at joints  32  to extend in a direction around the circumference of the annular member  10 , thereby increasing the distance/spacing between adjacent base members  20  and widening/changing the shape of each of the intervening inward and outward extending channels  12 ,  14 . The bridge members  30  can be constructed from a flexible material to accommodate flexing at joints  32  and/or lengthening/deformation during expansion of the annular member  10  and then substantially return to the original, non-expanded shape/configuration. The base members  20  can be constructed from a same or different material than the bridge members  30 . Accordingly, it is also contemplated that the base members  20  can flex and deform during expansion and contraction of the annular member  10 . 
     As illustrated in  FIG. 2B , in the expanded state the orientation of the base members  20  and bridge members  30  changes. Contact surfaces  22 ,  24  provided on the base members  20  now define the inner and outer diameters of the annular member  10 , respectively. In the expanded state, the contact surfaces  24  define the inner diameter of the outer layer  50 . The contact surfaces  22  extend towards the interior of the annular member  10  and reduce the contact surface area between the annular member  10  and the passing device, thereby lowering the coefficient of friction/resistance between the inner surface  18  of the annular member  10  and the passing device. The contact surfaces  22 ,  24  can define rounded/curved ends  26  or linear/angled ends  28  when viewed in cross-section. For example, the contact surfaces  22 ,  24  of the expanded embodiments shown in  FIGS. 2B, 3B, 4B, 5B and 6C  include rounded ends  26  in cross-section. In another example, the expanded annular member depicted in  FIG. 7B  includes both angled ends  28  and rounded ends  26  at the contact surfaces  22 ,  24 . Referring back to  FIG. 2B , the shape of the rounded ends  26 , including the radii of curvature, can be constant across all base members  20  of the annular member  10 . It is also contemplated that the shape of the rounded ends  26 /contact surfaces  22 ,  24  may vary between base members  20 , and vary between contact surface  22  and contact surface  24  of the same base member  20 . 
     In transition back to the non-expanded state, the base members  20  and bridge members  30  move back to their original configuration/orientation. The transition back to the non-expanded state can be facilitated by the inclusion of an elastic outer layer  50  that extends over the elongated annular member  10 . The outer layer  50  comprises a material having a higher elastic modulus than the annular member  10 , which enables the outer layer  50  to force the annular member  10  back into the non-expanded state after passage of the cardiovascular device. The annular member  10  can be made of a more lubricious material than the outer layer  50 . For example, the outer layer  50  can be made of, or incorporate, polyurethane, silicone, and/or rubber, and the annular member  10  can be made of, or incorporate, high density polyethylene, polytetrafluoroethylene, and/or other fluoropolymers. 
       FIGS. 3A and 3B  depict another example sheath  1  including an annular member  10  and elastic outer layer  50 . The annular member  10  has a plurality of base members  20  arranged around the circumference of the annular member  10  and bridge members  30  extending between opposing pairs of base members  20 . As illustrated in  FIG. 3A , the base members  20  and bridge members  30  can define a curvilinear shape in cross-section. For example, as depicted in  FIG. 3A , the base member  20  can define an elongated portion extending around the outer surface/diameter  16  of the annular member and terminating in a rounded end  26  contact surface  24 . The bridge  30  can define an elongated member having substantially linear and parallel sides and terminating at a curved end proximate the inner surface/diameter  18  of the annular member  10 . 
     Similar to the annular member  10  depicted in  FIG. 2A , in the non-expanded state the annular member  10  of  FIG. 3A  includes longitudinally extending channels  12 ,  14  defined between a bridge member  30  and adjacent base member  20  alternating in inward versus outward directionality around the circumference of the annular member  10 . The inward extending channels  12  extend inward from the outer surface/diameter  16  of the annular member  10  and the outward extending channels  14  extend outward from the inner surface/diameter  18  of the annular member  10 . The inward and outward extending channels  12 ,  14  can extend inward or outward from the inner/outer surface  16 ,  18  at an angle, e.g., at an angle other than 90-degrees (with respect to a line tangent to the diameter of the annular member  10  proximate the opening of the channel). 
     As described above, the annular member  10  and the elastic outer layer  50  of the sheath  1  are designed to locally expand in a radial direction between a non-expanded and an expanded state as the prosthetic device  212  is passed through the interior lumen of the sheath  1 .  FIG. 3B  illustrates the annular member  10  and outer layer  50  in an expanded state. The orientation and/or shape of the base members  20  and bridge members  30  of the annular member  10  change during expansion. As illustrated in  FIG. 3B , the base members  20  extend and elongate in a direction around the circumference of the annular member  10  when transitioned to the expanded state. The bridge members  30  change in orientation during expansion. In the non-expanded state the bridge members  30  extend is a direction toward/angled with respect to the longitudinal axis  11 /the interior of the annular member  10 . Upon expansion of the annular member  10  the bridge members  30  rotate, elongate and/or extend in a direction around the circumference of the annular member  10 . For example, the bridge members  30  can flex at joints  32  to facilitate their change in orientation with respect to the base members  20 . Upon expansion of the annular member  10 , the distance/spacing between adjacent base members  20  increases, widening and changing the shape of the intervening inward and outward extending channels  12 ,  14  and increasing the overall diameter of the annular member  10  and the outer layer  50 . 
     As illustrated in  FIG. 3B , in the expanded state the contact surfaces  22  provided on the base member  20  and/or bridge member  30  define the inner diameter of the annular member  10 . Likewise, the contact surface  24  defines the outer diameter of the annular member  10 , and the corresponding inner diameter of the outer layer  50  in the expanded state. The outside surface of the outer layer  50  defines the outermost diameter of the combined annular member  10 /outer layer  50 . Contact surfaces  22  reduce the contact surface area between the annular member  10  and the passing device, thereby lowering the coefficient of friction/resistance between the inner surface  18  and the passing device. 
       FIGS. 4A and 4B  depict an example sheath  1  including an annular member  10  and elastic outer layer  50 . The annular member  10  has four base members  20  arranged around the circumference of the annular member  10  and four corresponding bridge members  30  extending between opposing pairs of base members  20 . In the non-expanded state, the base members  20  and bridge members  30  can define a curvilinear shape in cross-section. For example, as depicted in  FIG. 4A , the base members  20  can define two arcuate portions having substantially similar shape terminating in two substantially linear portions extending in a radial direction with respect to the annular member  10 . The bridge members  30  can define an S-shape in cross-section. 
     Similar to the annular member  10  depicted in  FIGS. 2A and 3A , in the non-expanded state the annular member  10  of  FIG. 4A  includes longitudinally extending channels  12 ,  14  defined between a bridge member  30  and adjacent base member  20  alternating in inward versus outward directionality around the circumference of the annular member  10 . The inward and outward extending channels  12 ,  14  extend radially with respect to the longitudinal axis  11  of the annular member  10 . For example, the centerline of each of the inward and outward extending channels  12 ,  14  creates a 90-degree angle with a line tangent to the diameter of the annular member  10  proximate the opening of the channel. 
     As described above, the annular member  10  and the elastic outer layer  50  are designed to locally expand in a radial direction between a non-expanded and an expanded state as the prosthetic device  212  is passed through the interior lumen of the sheath  1 .  FIG. 4B  illustrates the annular member  10  and outer layer  50  in an expanded state. The orientation and/or shape of the base members  20  and bridge members  30  of the annular member  10  change during expansion. As illustrated in  FIG. 4B , the base members  20  extend and/or elongate in a direction around the circumference of the annular member  10  when transitioned to the expanded state. The bridge members  30  also change in orientation and/or shape during expansion. In the non-expanded state the bridge members  30  extend is a direction toward the longitudinal axis  11 /the interior of the annular member  10 . Upon expansion of the annular member  10  the bridge members  30  rotate, elongate and/or extend in a direction around the circumference of the annular member  10 . For example, the bridge members  30  can flex at joints  32  to facilitate their change in orientation with respect to the base members  20 . Upon expansion of the annular member  10 , the distance/spacing between adjacent base members  20  increases, widening and changing the shape of the intervening inward and outward extending channels  12 ,  14  and increasing the overall diameter of the sheath and the outer layer  50 . 
     As illustrated in  FIG. 4B , in the expanded state the contact surfaces  22  provided on the base members  20  define the inner diameter of the annular member  10 . Likewise, the contact surface  24  defines the outer diameter of the annular member  10 , and the corresponding inner diameter of the outer layer  50  in the expanded state. It is contemplated that a portion of the inner surface  16  and outer surface  18  of the base member  20  can also define the inner and outer diameter of the annular member  10  in the expanded state. Contact surfaces  22  reduce the contact surface area between the annular member  10  and the passing device, thereby lowering the coefficient of friction/resistance between the annular member and the passing device. 
       FIGS. 5A and 5B  depict another example sheath  1  including an annular member  10  and elastic outer layer  50 . The annular member  10  has eighteen base members  20  arranged around the circumference of the annular member  10  and eighteen corresponding bridge members  30  extending between opposing pairs of base members  20 . In the non-expanded state, the base members  20  and bridge members  30  can define a curvilinear shape in cross-section. For example, as depicted in  FIG. 5A , the base members  20  can define a semi-rectangular shape. The bridge members  30  can define an S-shape in cross-section. 
     Similar to the annular members  10  depicted in  FIGS. 2A, 3A and 4A , in the non-expanded state the annular member  10  of  FIG. 5A  includes longitudinally extending channels  12 ,  14  defined between a bridge member  30  and adjacent base member  20  alternating in inward versus outward directionality around the circumference of the annular member  10 . The inward and outward extending channels  12 ,  14  extend radially with respect to the longitudinal axis  11  of the annular member  10 . For example, the centerline of each of the inward and outward extending channels  12 ,  14  creates a 90-degree angle with a line tangent to the diameter of the annular member  10  proximate the opening of the channel. 
     As described above, the annular member  10  and the elastic outer layer  50  are designed to locally expand in a radial direction between a non-expanded and an expanded state as the prosthetic device  212  is passed through the inner lumen of the sheath  1 .  FIG. 5B  illustrates the annular member  10  and outer layer  50  in an expanded state. The orientation and/or shape of the base members  20  and bridge members  30  of the annular member  10  change during expansion. As illustrated in  FIG. 5B , the base members  20  extend and/or elongate in a direction around the circumference of the annular member  10  when transitioned to the expanded state. The bridge members  30  also change in orientation and/or shape during expansion. In the non-expanded state the bridge members  30  extend in a direction toward the longitudinal axis  11 /the interior of the annular member  10 . Upon expansion of the annular member  10  the bridge members  30  rotate, elongate and/or extend in a direction around the circumference of the annular member  10 . For example, the bridge members  30  can flex at joints  32  to facilitate their change in orientation with respect to the base members  20 . Upon expansion of the annular member  10 , the distance/spacing between adjacent base members  20  increases, widening and changing the shape of the intervening inward and outward extending channels  12 ,  14  and increasing the overall diameter of the annular member  10  and the outer layer  50 . 
     As illustrated in  FIG. 5B , in the expanded state the contact surfaces  22  provided on the base members  20  define the inner diameter of the annular member  10 . Likewise, the contact surface  24  defines the outer diameter of the annular member  10 , and the corresponding inner diameter of the outer layer  50  in the expanded state. Contact surfaces  22  reduce the contact surface area between the annular member  10  and the passing device, thereby lowering the coefficient of friction/resistance between the annular member and the passing device. 
       FIGS. 6A and 6B  depict another example sheath  1  including an annular member  10  and elastic outer layer  50 . The annular member  10  has base members  20  arranged around the circumference of the annular member  10  and corresponding bridge members  30  extending between opposing pairs of base members  20 . 
     In the non-expanded state, the base members  20  and bridge members  30  can define a curvilinear shape in cross-section. For example, as depicted in  FIG. 6A , the base members  20  define a wedge shape. The bridge members  30  define an arcuate/curved shape in cross-section. 
     Similar to the annular members  10  depicted in  FIGS. 2A, 3A, 4A and 5A , in the non-expanded state the annular member  10  of  FIG. 6A  includes longitudinally extending channels  12 ,  14  defined between a bridge member  30  and adjacent base member  20  alternating in inward versus outward directionality around the circumference of the annular member  10 . The inward and outward extending channels  12 ,  14  extend radially with respect to the longitudinal axis  11  of the annular member  10 . For example, the centerline of each of the inward and outward extending channels  12 ,  14  creates a 90-degree angle with a line tangent to the diameter of the annular member  10  proximate the opening of the channel. The shape, in cross-section, of the inward and outward extending channels  12 ,  14  as depicted in  FIG. 6A  can include two substantially parallel and straight sides (defined by side wall  13  and side wall  15 ) that terminate at a rounded end  19 . The rounded end  19  can have a width/diameter greater than the width (w) of the corresponding inward and outward extending channels  12 ,  14 . 
     As described above, the annular member  10  and the elastic outer layer  50  of the sheath  1  are designed to locally expand in a radial direction between a non-expanded and an expanded state as the prosthetic device  112  is passed through the interior lumen of the sheath  1 .  FIG. 6B  illustrates the annular member  10  and outer layer  50  in an expanded state. The orientation and/or shape of the base members  20  and bridge members  30  of the annular member  10  change during expansion. As illustrated in  FIG. 6B , the base members  20  rotate, extend and/or elongate in a direction around the circumference of the annular member  10  when transitioned to the expanded state. For example, the base members  20  can rotate with respect to the central axis of each corresponding base member  20 . Similarly, the bridge members  30  also change in orientation and/or shape during expansion. In the non-expanded state the bridge members  30  define an arcuate shape that flexes to increase in radius/length upon expansion of the annular member  10 . It is also contemplated that the bridge members  30  can rotate, elongate and/or extend in a direction around the circumference of the annular member  10  upon expansion. Upon expansion of the annular member  10 , the distance/spacing between adjacent base members  20  increases, widening and changing the shape of the intervening inward and outward extending channels  12 ,  14  and increasing the overall diameter of the annular member  10  and the outer layer  50 . The wall thickness of the annular member  10  is thinner at the bridge members  30  than compared to the base members  20 . The decreased thickness at the bridge members  30  eases the bending of the bridge members  30  during expansion, lessening the chance of fracture. 
     As illustrated in  FIG. 6B , in the expanded state the contact surfaces  22  provided on the base members  20  define the inner diameter of the annular member  10 . Likewise, the contact surface  24  defines the outer diameter of the annular member  10 , and the corresponding inner diameter of the outer layer  50  in the expanded state. Contact surfaces  22  reduce the contact surface area between the annular member  10  and the passing device, thereby lowering the coefficient of friction/resistance between the annular member and the passing device. 
     As illustrated in  FIGS. 2A, 3A, 4A, 5A, 6A and 7A , the size, shape, spacing and number of channels can vary. For example, the non-expanded embodiments of  FIG. 2A  and  FIG. 7B  have twenty four combined inward and outward extending channels  12 ,  14 . The non-expanded embodiments of  FIG. 3A  and  FIG. 6A  have twenty combined inward and outward extending channels  12 ,  14 , the non-expanded embodiment of  FIG. 4A  has eight combined inward and outward extending channels  12 ,  14 , and the non-expanded embodiment of  FIG. 5A  has thirty six combined inward and outward extending channels  12 ,  14 . 
     Sheaths of the present disclosure can be used with various methods of introducing a prosthetic device into a patient&#39;s vasculature. Generally, during use, the expandable sheath  1  is passed through the skin of patient (usually over a guidewire) such that the distal end region of the expandable sheath  1  is inserted into a vessel, such as a femoral artery, and then advanced to a wider vessel, such as the abdominal aorta. The delivery apparatus  210  is then inserted through the expandable sheath  1 . The prosthetic device is then delivered to the implantation site and implanted within the patient. During the advance of the prosthetic device through the expandable sheath  1 , the device and its delivery system exerts a radially outwardly directed force on the portion of the annular member  10 , the annular member  10  exerts a corresponding radially outwardly directed force on the outer layer  50 , causing both the annular member  10  and the outer layer  50  to expand locally to accommodate the profile of the device. The expansion of the annular member  10  widens the longitudinally extending channels  12 ,  14  of the annular member and causes the movement of longitudinally extending contact surfaces  22 ,  24  toward the inner and outer surfaces  16 ,  18  of the annular member  10 . 
     As the prosthetic device and its delivery system passes through the expandable sheath  1 , the expandable sheath  1  recovers. That is, it returns to its original, non-expanded configuration. In some embodiments, this is facilitated by outer layer  50 , which has a higher elastic modulus than annular member  10 . The outer layer  50  moves the contact surfaces  22 ,  24  of the annular member  10  away from the inner and outer surfaces after the passage of the prosthetic valve  212 . 
     As described above, the expandable sheath  1  can be used to deliver, remove, repair, and/or replace a prosthetic device. In one example, the expandable sheath  1  described above can be used to deliver a tissue heart valve to a patient. For example, a tissue heart valve (in a crimped state) can be placed on the distal end portion of an elongated delivery apparatus and inserted into the sheath. Next, the delivery apparatus and crimped heart valve can be advanced through the patient&#39;s vasculature to the treatment site, where the valve is implanted. 
     Beyond transcatheter heart valves, the expandable sheath  1  can be useful for other types of minimally invasive surgery, such as any surgery requiring introduction of an apparatus into a subject&#39;s vessel. For example, the expandable sheath  1  can be used to introduce other types of delivery apparatus for placing various types of intraluminal devices (e.g., stents, stented grafts, balloon catheters for angioplasty procedures, etc.) into many types of vascular and non-vascular body lumens (e.g., veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.). 
       FIGS. 7A-7C  show cross-sections of an expandable sheath  1  including an annular member  10  and outer layer  50  similar to the annular member  10  and outer layer  50  depicted in  FIGS. 2A and 2B .  FIG. 7A  shows a cross-sections of an expandable sheath  1  during an intermediate processing step that includes a second material in addition to the material used to form the annular member  10 . During processing, a tube is coextruded containing a first material  60  and a second material  62 . The first material  60  defines the annular member  10  discussed above. The second material  62  does not adhere to the first material  60  and defines a first and second set of longitudinally extending ribbons  64 ,  66 . The second material  62  could be, or could incorporate, nylon, polyethylene terephthalate, and/or polybutylene terephthalate, for example. The first and second set of ribbons  64 ,  66  form the inward and outward extending channels  12 ,  14  of the annular member  10  during the extrusion process. The first set of ribbons  64  extends inwardly from the outer surface  16  toward the inner surface  18  of the annular member  10 , and the second set of ribbons  66  extends outwardly from the inner surface  18  toward the outer surface  16  of the annular member  10 . Each ribbon of a selected set is positioned circumferentially between two ribbons of the other set. 
     In some embodiments, the second material  62  is a sacrificial material. For example, the ribbons  64 ,  66  of the second material  62  shown in  FIG. 7A  are removed after coextrusion, exposing the longitudinally extending channels  12 ,  14  described above and as shown in the non-expanded embodiment of  FIG. 7B . 
     However, some embodiments, such as the one shown in  FIG. 6A , the first material  60  and second material  62  of the annular member  10  is coextruded with a third material  68 . This third material  68  is in contact with a portion of the first material  60  and a portion of the second material  62 , and adheres to both the first and second materials  60 ,  62 . Because of the adherent third material  68 , the second material  62  is not removed. However, it still does not adhere to first material  60 . Instead, the third material  68  acts as a tie layer to hold the first and second materials  60 ,  62  together during expansion of the annular member  10 . This eliminates the need to remove the ribbons  64 ,  66  of the second material  62  prior to use, while still allowing a widening of a channel between the non-adherent first  60  and second  62  materials during the expansion of the annular member  10 . The retention of the second material  62  also increases the torque of the finished sheath, so that a user finds it easier to twist the sheath. 
     Some methods include a step of covering the annular member  10  with the outer layer  50  after coextrusion. As discussed above, the outer layer  50  is formed of, or incorporates, a material with a higher elastic modulus than the annular member  10 . 
       FIG. 8  shows a perspective view of an example sheath  1 . In this view, only the outer layer  50  is visible. The sheath  1  comprises a proximal end  3  and distal end  5  opposite the proximal end  3 . The sheath  1  can comprise a hemostasis valve inside the lumen of the sheath  1 , at or near the proximal end  3 . The sheath  1  can include a taper tube  70 , a flared proximal end. In some embodiments of the method of making, the taper tube  70  is added to the coextrusion. The addition of the second material  62  will stabilize the coextrusion process and make it possible to add a taper tube  70  during extrusion. This is advantageous because it makes it possible to eliminate the typical taper tube manufacturing steps of flaring (increasing the inner diameter of the sheath) and bonding (increasing the wall thickness after flaring). 
     Additionally, the sheath  1  can comprise a soft distal tip  80  at the distal end  5 . The soft tip  80  can be provided with a lower hardness than the other portions of the sheath  1 . In addition to the method of making the expandable sheath described above, a method of making a distal tip  80  of an expandable sheath  1  is demonstrated in the flow chart of  FIG. 9 . The distal tip  80  can be formed on the annual member  10 , outer layer  50 , or on the annular member  10  and outer layer  50  combined. The distal tip  80  of the expandable sheath  1  is softer and more elastic than the more proximal regions of the expandable sheath  1  because it must give easily when encountering tissue to reduce the possibility of injury and it must retain the ability to expand after the sealing (reflowing) process wherein the distal tip  80  is sealed to prevent blood from entering the space between the annular member  10  and the outer layer  50 . A first step to making the distal tip  80  is to attach a separate distal tube  82  to the distal end  5  of the expandable sheath  1 , for example, by reflowing the materials together. Alternatively, the distal tube  82  can be added to the distal end  5  of the sheath  1  via specialized extrusion technology. The distal tube  82  is formed of, or incorporates, a material having greater elasticity than the remainder of the expandable sheath  1 . One example material is Pebax. 
     Next, a portion of the distal tube  82  is pinched to create a longitudinally extending outer crease  84 . The pinched portion is folded over an outer surface of the distal tube  82  in a circumferential direction, creating a longitudinally extending flap  86  that is bounded by the outer crease  84  and a longitudinally extending inner crease  85 . The inner crease  85  of the flap  86  is cut in a longitudinal direction from the distal edge  83  of the distal tube  82  to a proximally spaced point along the longitudinal axis of the distal tube  82 . This creates a longitudinally extending inner edge  87 . The flap  86  is cut circumferentially from the outer crease  84  to the inner crease  85  at the proximally spaced point, such that the longitudinal cut of the inner crease  85  meets the circumferential cut at the proximally spaced point. The inner edge  87  of the flap is then extended in a circumferential direction around the outer surface  81  of the distal tube  82  and adhered to the outer surface  81 . 
     In some embodiments, such as the one shown in  FIG. 9 , adhering the inner edge  87  of the flap  86  to the outer surface  81  can include covering the distal end with an outer jacket  88 , then reflowing the outer jacket  88  with the distal tube  82  to form a sealed distal end. The outer jacket  88  is also formed of highly elastic materials. One example material is Neusoft. This outer jacket  88  can, in some embodiments, be the same layer as the outer layer  50  shown in  FIGS. 2A-B . Because the flap  86  is unfolded and wrapped around the outer surface  81  before reflowing, the final wall thickness of the resulting distal tip varies minimally around its circumference. 
     Although the foregoing embodiments of the present disclosure have been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced within the spirit and scope of the present disclosure. It is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.