Introducer sheath

Abstract

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

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Provisional Application No. 63 / 597,916, filed on November 10, 2023, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to apparatus, systems, and methods for use with introducer sheaths in medical procedures. More specifically, this disclosure relates to apparatus, systems, and methods for constructing introducer sheaths to reduce the risk of tissue trauma. Background Technology

[0004] Introducer sheaths and introducer sheath assemblies are used in a variety of minimally invasive and routine surgical procedures, such as endovascular delivery of surgical instruments. An introducer sheath typically includes an introducer sheath and at least one valve to control leakage during the introduction of a medical device or surgical instrument (e.g., an in-situ prosthesis, dilator, guidewire, etc.) into the introducer sheath. The introducer sheath may be sized to cause tissue trauma when inserted into the patient's anatomy. Additionally, during prolonged procedures, the introducer sheath may adhere to biological tissue, potentially increasing the difficulty of removal at the end of the procedure. Furthermore, adhesion to the introducer sheath can cause trauma to biological tissue. It remains desirable to provide introducer sheaths that are easier to remove and constructed to minimize trauma or tissue damage during insertion and removal. Summary of the Invention

[0005] An introducer sheath is provided having a construction for reducing trauma during insertion and removal of the introducer sheath during surgery.

[0006] According to one example (“Example 1”), an introducer sheath is used to introduce a transcatheter assembly into a patient, the introducer sheath being positioned at an entry site such that, during use, a portion of the introducer sheath is inside the body and a portion of the introducer sheath is outside the body. The introducer sheath includes: a sheath member including an inner portion and an outer portion, the inner portion defining an inner lumen through which an intracavitary device or other surgical instrument can be longitudinally moved, the outer portion surrounding at least a portion of the inner portion; a first hub coupled to the inner portion of the sheath member; and a second hub coupled to the outer portion of the sheath member, wherein, when the first hub is actuated away from the second hub, a portion of the length of the sheath member positioned on the outer portion transitions from the outer portion to the inner portion.

[0007] According to another example (“Example 2”), the introducer sheath of Example 1 also includes a reinforcement configured to be positioned between the inner and outer portions of the sheath member.

[0008] According to another example (“Example 3”) that goes further than Example 2, the reinforcement is an elongated member that defines an inner cavity and defines a slit along at least a portion of the longitudinal length of the reinforcement.

[0009] According to another example (“Example 4”) that goes further than Examples 2 and 3, the reinforcement is relatively stiffer than the sheath member, wherein the sheath member has at least one of the material properties of drape, conformability and low bending stiffness.

[0010] According to another example (“Example 5”) that goes further than Examples 2-4, the sheath member is configured to accommodate a structure having a diameter greater than that of the reinforcing member.

[0011] According to another example (“Example 6”) that goes further than any of the preceding examples, the sheath component is a thin film.

[0012] According to another example (“Example 7”) that goes further than any of the preceding examples, the introducer sheath assembly includes an expander positioned within an inner cavity defined by the inner portion of the sheath member.

[0013] According to another example (“Example 8”) that goes further than Example 7, the expander includes an expander tip and an expander body, wherein at least a portion of the diameter of the expander tip is larger than the diameter of the expander body.

[0014] According to another example (“Example 9”) that goes further than Example 8, when the sheath member is in the delivery configuration, at least a portion of the expander tip is flush with or has a diameter greater than that of the outer portion of the sheath member.

[0015] According to another example (“Example 10”) that goes further than Examples 7-9, the dilator can be removed from the lumen.

[0016] According to another example (“Example 11”) that goes further than any of the preceding examples, the introducer sheath assembly includes an introducer handle that includes a valve through which the sheath member extends.

[0017] According to another example (“Example 12”) that goes further than Example 11, the introducer handle includes a port through which a reinforcement extends.

[0018] According to another example (“Example 13”) that goes further than Example 12, the internal opening of the port is aligned to provide an entrance to the space between the first hub and the second hub.

[0019] According to another example (“Example 14”) that goes further than Example 1, at least a portion of the inner part of the sheath member is relatively harder than the outer part of the sheath member.

[0020] According to another example (“Example 15”) that goes further than Example 1, at least a portion of the interior of the sheath member includes an integral reinforcement.

[0021] According to another example (“Example 16”) that goes further than Example 1, at least a portion of the outer part of the sheath member includes holes through which at least one of fluid and therapeutic agent is deliverable.

[0022] According to another example that goes a step further than Example 2 (“Example 17”), the reinforcement is tapered.

[0023] According to another example (“Example 18”) that goes further than Example 1, the introducer sheath assembly includes an intraluminal device positioned on the catheter and constrained to the delivery diameter by a restraining member, wherein the diameter of the inner portion of the sheath member is larger than the delivery diameter of the intraluminal device, such that the intraluminal device can move longitudinally through the sheath member.

[0024] According to one example (“Example 19”), a method of assembling an introducer sheath includes: folding out a sheath member such that the sheath member defines an inner portion and an outer portion, the inner portion defining an inner cavity through which an in-cavity device can travel, the outer portion surrounding at least a portion of the inner portion, wherein a first hub is coupled to an inner portion of the sheath member and a second hub is coupled to the outer portion of the sheath member; inserting a reinforcement between the inner portion and the outer portion of the sheath member; and inserting an expander through the inner cavity.

[0025] According to another example (“Example 20”), the method includes joining a first hub and a second hub together.

[0026] According to one example (“Example 21”), an introducer sheath assembly includes: a sheath member operable to inwardly fold, the sheath member defining an inner cavity, the sheath member having at least one of the following material properties: drape, conformal, and low bending stiffness; a reinforcement removably positioned on and supporting the sheath member, the reinforcement having a stiffness relatively higher than that of the sheath member; an expander removably positioned within the inner cavity of the sheath member; and a hub coupled to the sheath member, wherein, when the hub is actuated, the hub operable to cause at least a portion of the sheath member to inwardly fold outward.

[0027] According to one example (“Example 22”), an introducer sheath assembly includes: a sheath member operable to fold inward or outward, the sheath member defining an inner cavity, the sheath member having at least one of the material properties of drape, conformability and low bending stiffness; and a reinforcement configured to removably engage and support the sheath member, the reinforcement having a stiffness relatively greater than that of the sheath member.

[0028] According to another example (“Example 23”) that goes further than Example 22, the sheath member includes an inner portion and an outer portion, wherein a space is defined between the inner portion and the outer portion, the space being configured to receive a reinforcement therein.

[0029] According to another example (“Example 24”) that goes further than Example 21 or 22, the introducer sheath also includes: an expander that is removably positioned within the cavity of the sheath member; and a hub that is coupled to the sheath member, wherein, when the hub is actuated, the hub is operable to cause at least a portion of the sheath member to fold inward and outward.

[0030] According to one example (“Example 25”), an introducer sheath for introducing a transcatheter assembly into a patient includes: a sheath member including an inner portion and an outer portion, the inner portion defining an inner lumen through which an intra-luminal device can extend longitudinally, the outer portion surrounding at least a portion of the inner portion; and a handle including: a first hub coupled to an inner portion of the sheath member; and a second hub coupled to the outer portion of the sheath member, wherein, when the first hub is translated away from the second hub, a portion of the length of the sheath member positioned on the outer portion is transferred from the outer portion to the inner portion.

[0031] According to another example (“Example 26”) that goes further than Example 25, the introducer sheath also includes a reinforcement configured to be positioned between the inner and outer portions of the sheath member.

[0032] According to another example (“Example 27”) that goes further than Example 26, the reinforcement is an elongated member that defines an inner cavity and defines a slit along at least a portion of the longitudinal length of the reinforcement.

[0033] According to another example (“Example 28”) that goes further than Examples 26-27, the reinforcement is relatively stiffer than the sheath member, wherein the sheath member has at least one of the material properties of drape, conformability and low bending stiffness.

[0034] According to another example (“Example 29”) that goes further than Examples 26-28, the sheath member is configured to accommodate a component having a diameter greater than that of the reinforcement.

[0035] According to another example (“Example 30”) that goes further than Examples 26-29, the introducer sheath also includes an introducer handle that includes a valve through which the sheath member extends.

[0036] According to another example (“Example 31”) that goes further than Example 30, the introducer handle includes a port through which a reinforcement extends.

[0037] According to another example (“Example 32”) that goes further than Example 31, the internal opening of the port is aligned to provide an entrance to the space between the first hub and the second hub.

[0038] According to another example (“Example 33”) that goes further than Examples 26-32, at least a portion of the inner portion of the sheath member is relatively harder than the outer portion of the sheath member.

[0039] According to another example (“Example 34”) that goes further than Examples 26-33, at least a portion of the interior of the sheath member includes an integral reinforcement.

[0040] According to another example (“Example 35”) that goes further than Examples 26-34, at least a portion of the outer part of the sheath member includes holes through which at least one of fluid and therapeutic agent is deliverable.

[0041] According to another example (“Example 36”) that goes further than Example 26, the reinforcement defines a first longitudinal edge portion adjacent to a first longitudinal edge and a second longitudinal edge portion adjacent to a second longitudinal edge, wherein the first longitudinal edge portion and the second longitudinal edge portion at least partially overlap to define an open key ring profile of the reinforcement.

[0042] According to another example (“Example 37”) that goes further than Example 36, the reinforcement includes a leading edge, a first angled edge extending between the leading edge and a first longitudinal edge, and a second angled edge extending between the leading edge and a second longitudinal edge.

[0043] According to another example (“Example 38”) that goes further than Example 26, the handle includes a port configured to receive a reinforcement, wherein the port defines an internal opening, and the handle defines a locator positioned adjacent to the internal opening, the locator being configured to position the reinforcement around at least a portion of the circumference of the interior of the sheath member.

[0044] According to another example (“Example 39”) that goes further than Example 38, the locator includes a first structure coupled to the second structure, wherein the first structure is sized at a first end such that the reinforcement can be positioned around the first structure.

[0045] According to another example (“Example 40”) that goes further than Example 39, the sheath component is operable to invert during removal from the blood vessel.

[0046] According to another example (“Example 41”) that goes further than Example 39, the sheath member is operable to translate into the blood vessel during insertion or evert into the blood vessel during insertion.

[0047] According to another example (“Example 42”), a delivery system includes the introducer sheath of Example 25, and further includes: an expander positioned within a lumen defined by an inner portion of the sheath member; and an intraluminal device positioned on the catheter and constrained by a restraining member to a delivery diameter, wherein the diameter of the inner portion of the sheath member is larger than the delivery diameter of the intraluminal device, such that the intraluminal device can move longitudinally through the sheath member.

[0048] According to one example (“Example 43”), a method of assembling an inlet sheath includes: turning the sheath member outward or inward such that the sheath member defines an inner portion and an outer portion, the inner portion defining an inner cavity through which an in-cavity device can travel, the outer portion surrounding at least a portion of the inner portion, wherein a first hub is coupled to the inner portion of the sheath member and a second hub is coupled to the outer portion of the sheath member; and inserting a reinforcement between the inner portion and the outer portion of the sheath member.

[0049] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided in this disclosure. Although several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the illustrative examples shown and described below in the detailed description. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive. Attached Figure Description

[0050] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrating embodiments and serving, together with the description, to explain the principles of the present disclosure.

[0051] Figure 1 It is an introducer sheath assembly according to one embodiment; and

[0052] Figure 2A and Figure 2B It is a hub formed according to various embodiments for a handle for an introducer sheath assembly; Figure 3A Includes various components of an introducer sheath assembly according to one embodiment; Figure 3B Including according to Figure 3A The various components of the inlet sheath assembly are in the assembly state; Figures 4A to 4H An introducer assembly at different times during the use of the introducer assembly is shown according to one embodiment; Figure 5 An introducer sheath according to one embodiment has features that may be included in various embodiments, including any of the features shown in the foregoing figures; Figures 6A to 6L An exemplary process is illustrated according to one embodiment, including inserting an introducer assembly into a blood vessel, delivering an intraluminal device, and removing the introducer assembly from the blood vessel. Figures 7A to 7C These are illustrations of reinforcements in various embodiments; and Figures 8A to 8D Various views of a handle having a port for inserting a reinforcing member, according to one embodiment. Detailed Implementation

[0053] Definitions and Terms

[0054] This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be read broadly in the context of the meanings that a person skilled in the art would assign to such terms.

[0055] Regarding the terminology of inaccuracy, the terms "approximately" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement and any measurement reasonably close to it. A measurement reasonably close to the stated measurement deviates from it by a reasonably small amount, as understood and readily determined by one of ordinary skill in the art. Such deviations may be attributable to, for example, measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting the measurement, differences in measurements related to other components to optimize performance and / or structural parameters, specific implementation scenarios, minor adjustments made by humans or machines to the object without precise adjustment and / or manipulation, etc. If it is determined that a person of ordinary skill in the art would not readily determine the numerical value of such a reasonably small difference, the terms "approximately" and "approximately" may be understood to mean ±10% of the value.

[0056] Description of various embodiments

[0057] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended function. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale but may be enlarged to illustrate various aspects of this disclosure; in this regard, the drawings should not be construed as limiting. This disclosure generally relates to inlet sleeves and inlet sleeve assemblies.

[0058] Figure 1The introducer sheath assembly 10 shown is provided as an example of various features of an introducer sheath assembly, and although combinations of those features shown are clearly within the scope of the invention, this example and its illustrations do not imply that the inventive concept provided herein is limited to fewer features, additional features, or alternative features that may be... Figure 1 One or more features are shown. For example, in various embodiments, Figure 1 The hub of the introducer sheath shown may include reference Figure 2A To the outline or port described in Figure 3 or Figure 5 The various other features shown. It should also be understood that, conversely, they are also present. Figure 1 One or more components depicted in Figure 2 may be deployed as a supplement to or replacement for the components depicted in Figure 2.

[0059] The introducer sheath assembly 10 can be inserted into a patient to provide access to the patient's anatomical structures, such as the vascular system or other lumens or bodies. The introducer sheath assembly 10 is configured to limit or reduce trauma to surrounding tissues when inserted and removed from the patient's anatomy. The introducer sheath assembly 10 can reduce or limit shear forces between the introducer sheath assembly 10 and surrounding tissues during insertion and removal. The introducer sheath assembly 10 facilitates the insertion of surgical, endoscopic, transcatheter, and other devices into the body. The introducer sheath assembly 10 can facilitate the insertion of devices with a diameter larger than the original diameter of the introducer sheath assembly 10 during initial insertion or cannulation into the patient.

[0060] Reference Figure 1 An embodiment of an introducer sheath assembly 10 is shown. The introducer sheath assembly 10 includes a sheath member 12, a first hub 14, a second hub 16, a reinforcement 18, and a dilator 20. The sheath member 12 and the dilator 20 are operable to be inserted into a patient, thereby providing an access site for surgery. The dilator 20 can be removed to provide passage through the hubs 14, 16, and the sheath member 12, through which devices and instruments can be delivered. The reinforcement 18 may be positioned within the sheath member 12 (e.g., therein) to provide longitudinal support for the sheath member 12 during use.

[0061] In some embodiments, the sheath member 12 includes an inner cavity 21, an inner portion 22 (e.g., defining the inner cavity 21), and an outer portion 24 through which an intracavity device can travel, and the outer portion 24 surrounds at least a portion of the inner portion 22 (see...). Figure 4AThe sheath member 12 may be formed of a film, laminate, or other flexible material that provides sufficient strength to resist abrasion or tearing during insertion, removal, movement, or hinged engagement when a component is positioned through the sheath member 12. Several non-limiting examples of materials that may be implemented alone or in combination include expanded polytetrafluoroethylene (ePTFE), polypropylene, or expanded polyethylene (ePE), etc. These exemplary materials may be used in the form of films, as strips, films, wraps, outer wraps, etc. In some embodiments, the sheath member 12 may be formed of a flexible or bendable material, such that it has low bending resistance. Additionally, the sheath member 12 may be formed of a thin material. For example, the thickness of the material may be from approximately 0.010 mm to approximately 0.200 mm. In some embodiments, the thickness of the material is approximately 0.010 mm to approximately 0.015 mm, approximately 0.015 mm to approximately 0.020 mm, approximately 0.020 mm to approximately 0.025 mm, approximately 0.025 mm to approximately 0.030 mm, approximately 0.030 mm to approximately 0.035 mm, approximately 0.035 mm to approximately 0.040 mm, approximately 0.040 mm to approximately 0.045 mm, approximately 0.045 mm to approximately 0.050 mm, approximately 0.050 mm to approximately 0.045 mm, approximately 0.050 mm to approximately 0.045 mm, approximately 0.050 mm to approximately 0.045 mm, approximately 0.050 mm to approximately 0.045 mm, approximately 0.050 mm to approximately 0.025 mm, approximately 0.025 mm to approximately 0.025 mm, approximately 0.025 mm to approximately 0.030 mm, approximately 0.030 mm to approximately 0.035 mm, approximately 0.035 mm to approximately 0.040 mm, approximately 0.040 mm to approximately 0.045 mm, approximately 0.045 mm to approximately 0.050 mm, approximately 0.050 mm to approximately 0.045 mm, approximately 0.025 mm to approximately 0.02 ... The material thickness ranges from approximately 0.060 mm to approximately 0.070 mm, approximately 0.070 mm to approximately 0.080 mm, approximately 0.080 mm to approximately 0.090 mm, approximately 0.090 mm to approximately 0.100 mm, approximately 0.120 mm to approximately 0.120 mm to approximately 0.140 mm, approximately 0.140 mm to approximately 0.160 mm, approximately 0.160 mm to approximately 0.180 mm, and approximately 0.180 mm to approximately 0.200 mm. The material thickness contributes to a low profile, reducing the size of the sheath member 12 during insertion. Other material properties of the sheath member 12 may include at least one of drape, conformability, low bending stiffness, abrasion resistance, puncture resistance, lubricity, and high tensile strength. In some embodiments, the sheath member 12 is formed of a composite film comprising a densified ePTFE film covered with a thin, non-porous layer of fluorinated ethylene propylene (FEP) (approximately 0.24 wt% of the composite film). The composite film may include the following properties: areal density (MPA) of approximately 17.42 g / m², thickness of approximately 0.0076 mm, longitudinal tensile strength (machine direction; MD) of approximately 288 MPa, transverse tensile strength (TD) of approximately 68.3 MPa, and isopropanol (IPA) bubble point (measured according to ASTM F316-86) of approximately 586 kPa. In some embodiments, a biaxially oriented expanded ultra-high molecular weight polyethylene (UHMWPE) film may be implemented together with the sheath member 12. This biaxially oriented expanded UHMWPE film is prepared according to methods commonly used for casting and orientation gel processing of polyethylene films.The UHMWPE film has the following characteristics: areal density (MPA) of approximately 2.3 g / m², thickness of approximately 0.0031 mm, average flow orifice diameter (MFP) of approximately 0.000221 mm, longitudinal tensile strength (machine direction; MD) of approximately 264 MPa, and transverse tensile strength (TD) of approximately 366 MPa.

[0062] The sheath member 12 can be folded outwards or inwards to define an inner portion 22 and an outer portion 24. It should be understood that regardless of whether the sheath member 12 is folded inwards or outwards, the process defines the inner portion 22 and the outer portion 24 as defined herein, and has a movable transition portion 23. Therefore, in some embodiments, the inner portion 22 and the outer portion 24 are continuous with each other. When the sheath member 12 is folded outwards, a transition portion 23 can be defined between the inner portion 22 and the outer portion 24 (e.g., folded). The transition portion 23 defines the portion that allows the sheath member 12 to transition between the inner portion 22 and the outer portion 24. As will be discussed in more detail below, the inner portion 22, the transition portion 23, and the outer portion 24 are defined by their relative positions and orientations, rather than by a specific length of the sheath member 12. This is because, during use, the sheath member 12 can be actuated to cause a portion of the sheath member 12 defined as the outer portion 24 to change from the outside of the inner portion 22 via the transition portion 23, for example, by folding inwards to become part of the inner portion 22. Conversely, the sheath member 12 can be actuated to cause a portion of the sheath member 12 defined as the inner portion 22 to change from the inside of the outer portion 24 (e.g., by folding outwards) to become part of the outer portion 24. In some embodiments, the delivery configuration includes an inner portion 22 and an outer portion 24 (see...). Figure 4A The inner portion 22 can be formed of different materials or different material thicknesses. For example, the inner portion 22 can be thicker than the outer portion 24. This makes it easier for the outer portion 24 to conform to the inward-outward folding, as discussed herein, while the inner portion 22 is operable to facilitate the passage of the intracavity device 100 therethrough. In some embodiments, the inner portion 22 can be externally wrapped with a thickness greater than that of the outer portion 24. A space 25 is defined between the inner portion 22 and the outer portion 24. The space 25 is configured to receive the reinforcement 18 therein, which will be discussed in more detail below.

[0063] Still refer to Figure 1 The introducer sheath assembly 10 includes a first hub 14 coupled to an inner portion 22 (e.g., first end 26) of the sheath member 12 and a second hub 16 coupled to an outer portion (e.g., second end 28) of the sheath member 12 (see [link]). Figure 4A The first hub 14 and the second hub 16 may be operable to connect with each other to define at least a portion of the handle 30 (e.g., rotary connection, such as threaded engagement, snap and pawl engagement, fastener, buckle, etc.). Figure 2A and Figure 2B An additional embodiment of a first hub 14 and a second hub 16 is shown. The first hub 14 and the second hub 16 can be selectively engaged and disengaged from each other. When the first hub 14 and the second hub 16 are disengaged from each other, the first hub 14 can be actuated (e.g., translated) away from the second hub 16 to cause an inward-outward folding of at least a portion of the sheath member 12 (e.g., the transition portion 23 moves distally). The first hub 14 and the second hub 16 include cavities through which an in-cavity device can travel. The first hub 14 and the second hub 16 are generally coaxially aligned with each other and with at least a portion of the sheath member 12. The first hub 14 and the second hub 16 are positioned such that when engaged, they are longitudinally aligned with each other, with an inner portion 22 of the sheath member 12 extending from the first hub 14 and passing through the cavity of the second hub 16 (see [link to relevant documentation]). Figure 4A The sheath member 12 continues to extend away from the second hub 16 (e.g., inner portion 22), then folds back (e.g., transition portion 23) and extends to the second hub 16 (e.g., outer portion 24).

[0064] In some embodiments, the reinforcement 18 may be disposed together with the introducer sheath assembly 10. The reinforcement 18 is operable to provide columnar strength to the sheath member 12. This allows the sheath member 12 to travel through the insertion site and into the tissue without substantial collapse, longitudinal compaction, or bundle formation. The reinforcement 18 is relatively stiffer than the sheath member 12, which facilitates the ability to impart columnar strength to the introducer sheath assembly 10 during insertion. For example, the sheath member 12 may be formed of a soft material to allow it to collapse to a smaller diameter for easy insertion and expand outwards during use, while the reinforcement 18 is formed of a relatively stiffer material to provide columnar strength to the sheath member upon insertion. In some embodiments, the reinforcement 18 is configured to be positioned between the inner portion 22 and the outer portion 24 of the sheath member 12 (see [link to documentation]). Figure 4A The reinforcement 18 may include a first end 40 and a second end 42. The first end 40 may be inserted or positioned between the inner portion 22 and the outer portion 24, and the first end 40 is advanced to contact the transition portion 23 of the sheath member 12 to provide columnar support, extension, and / or elongation for the sheath member 12. In embodiments where the reinforcement 18 is operable to collapse the sheath member 12 to a smaller diameter, the reinforcement 18 may be configured to have a predetermined shape (e.g., C-shaped) and to return to that shape. The sheath member 12 is conformable such that when positioned together with the reinforcement 18, the sheath member 12 can collapse to a smaller diameter.

[0065] For example, in some embodiments, the sheath member 12 may be configured to have an inner diameter of approximately 10 mm, but constrained to a diameter of approximately 5 mm by the reinforcement 18. In other examples, the sheath member 12 includes inner diameters of approximately 3 mm to approximately 4 mm, approximately 4 mm to approximately 5 mm, approximately 5 mm to approximately 6 mm, approximately 6 mm to approximately 7 mm, approximately 7 mm to approximately 8 mm, approximately 8 mm to approximately 9 mm, approximately 9 mm to approximately 10 mm, approximately 10 mm to approximately 11 mm, approximately 11 mm to approximately 12 mm, approximately 12 mm to approximately 13 mm, approximately 13 mm to approximately 14 mm, and approximately 14 mm to approximately 15 mm. The reinforcement 18 includes a diameter relatively smaller than the inner diameter of the sheath member 12, such that when engaged with the reinforcement 18, the sheath member 12 is reduced to a smaller profile. In some embodiments, the sheath member 12 decreases from an inner diameter of about 10 mm to an outer diameter of about 4 mm to about 9 mm, from an inner diameter of about 9 mm to an outer diameter of about 4 mm to about 8 mm, from an inner diameter of about 8 mm to an outer diameter of about 3 mm to about 7 mm, from an inner diameter of about 7 mm to an outer diameter of about 3 mm to about 6 mm, from an inner diameter of about 6 mm to an outer diameter of about 3 mm to about 5 mm, from an inner diameter of about 5 mm to an outer diameter of about 2 mm to about 4 mm, from an inner diameter of about 4 mm to an outer diameter of about 2 mm to about 3 mm, or from an inner diameter of about 3 mm to an outer diameter of about 2 mm. The reduction in diameter can be facilitated by the shape of the reinforcement 18 and may result in pleats, folds, or corrugations in the sheath member 12. As discussed herein, the sheath member 12 is configured to expand from a reduced diameter toward a larger diameter as components (e.g., intracavitary devices 100 and delivery systems) pass through the cavity 21. In embodiments where the reinforcement 18 can expand to accommodate those components, this can occur while the reinforcement 18 is still engaged with the sheath member 12, or it can occur during the removal of the reinforcement 18.

[0066] In some embodiments, the reinforcement 18 is an elongated member defining an inner cavity. The inner cavity allows the reinforcement 18 to at least partially surround the inner portion 22 of the sheath member 12. The reinforcement 18 may include at least one slit 44 along at least a portion of the longitudinal length of the reinforcement 18, including extending to the proximal end 19 of the reinforcement 18. The slit 44 facilitates both the expansion of the diameter of the reinforcement 18 and simplifies the insertion of the reinforcement 18 into and removal from the space 25 defined between the inner portion 22 and the outer portion 24 of the sheath member 12. The reinforcement 18 may include any number of slits 44. For example, Figure 3AA reinforcement 18 with two slits 44 is shown. In some embodiments, the reinforcement 18 may include a single slit to define a C-shaped profile. In some embodiments, the reinforcement 18 may include slits 44, wherein the longitudinal edges of the reinforcement 18 adjacent to the slits partially overlap (see [link to documentation]). Figure 7B and Figure 7C (and related discussions below). In other words, the C-shaped profile of the reinforcement 18 can be compressed or circumferentially tightened to define an overlapping construction (e.g., the C-shaped profile is compressed into a spiral or open key ring profile), which can help reduce kinking and allow robust reintroduction (e.g., increased columnar strength). The slit allows the reinforcement 18 to be mounted or slide through the interior portion 22 of the sheath member 12 in a transverse direction from the axis of the sheath member 12 without having to pass through or accommodate the hubs 14, 16. As previously mentioned, the slit 44 also helps to accommodate components inserted through the cavity 21 of the sheath member 12 when the reinforcement 18 engages with the sheath member 12. The slit 44 defining the C-shaped profile allows for radial expansion when a component with a diameter larger than the reinforcement 18 engages with the sheath member 12 and slides through it. It should also be understood that the sheath member 12 can be oversized to allow for expansion. For example, in some embodiments, the sheath member 12 may have a diameter larger than that of the reinforcement 18 (e.g., when the reinforcement 18 is in a delivery configuration or an expanded diameter configuration). Because the sheath member 12 is flexible, it can be constrained to a delivery configuration (e.g., by the reinforcement). However, the sheath member 12 can expand when a component requiring additional space is inserted. Thus, the sheath member 12 may include a smaller profile (e.g., a delivery configuration) for easy insertion into a patient, but can subsequently expand to an expanded diameter configuration to accommodate a larger diameter component. The reinforcement 18 (e.g., a C-shaped profile embodiment) can then be implemented to bias the sheath member 12 back to the reduced diameter configuration (e.g., a delivery configuration). In some embodiments, the reinforcement 18 may include a tapered profile along at least a portion of the longitudinal length of the reinforcement.

[0067] Go to Figure 2A and Figure 2B Hubs 14 and 16 may include ports 32. The ports may be located in the first hub 14 (e.g., Figure 2A ) or second hub 16 (e.g., Figure 2BIn some embodiments, port 32 facilitates access to the space 25 between the inner portion 22 and the outer portion 24 of the sheath member 12. In some embodiments, port 32 includes an internal opening longitudinally positioned between the first hub 14 and the second hub 16. Port 32 can be used to insert and remove a reinforcement 18 into and from the space 25 between the inner portion 22 and the outer portion 24 of the sheath member 12. Port 32 may include features facilitating insertion of the reinforcement 18 into the space 25. For example, when the reinforcement 18 includes a C-shaped profile, port 32 may include markings to aid in the proper orientation of the reinforcement 18, allowing the slit 44 to span the inner portion 22 so that the reinforcement 18 can at least partially surround the inner portion 22. Port 32 may also be used for other reasons to provide access to the space 25 between the inner portion 22 and the outer portion 24. For example, port 32 may be implemented to provide fluid therebetween to at least partially inflate the outer portion 24. Additionally, the outer portion 24 may also be porous or perforated on at least a portion of its surface, such that the port 32 can be used to fill the space with fluid (e.g., a drug, saline, a therapeutic agent, etc.) to deliver the fluid through the outer portion 24 to surrounding tissues or to the patient's internal lumen (e.g., the vascular system).

[0068] In some embodiments, the handle 30 may include additional ports and accessories. For example, the first hub 14 or the second hub 16 may include a valve assembly 34 to limit fluid leakage from the hub during use.

[0069] return Figure 1 The introducer sheath assembly 10 may include a dilator 20. The dilator 20 may be positioned within a lumen 21 defined by an inner portion 22 of the sheath member 12. The dilator 20 is configured to provide support for the sheath member 12 during insertion. The dilator 20 may be a flexible, elongated dilator, and in some embodiments, it may be provided with a hub 50 and a locking knob (not shown) for engaging a handle 30. The dilator 20 may be inserted through the valve assembly 34, hubs 14, 16, and sheath member 12. The annular portion of the hub 50 is radially aligned with the dilator 20 relative to the valve assembly 34 and the sheath member 12. In some embodiments, the dilator 20 may include a locking element for maintaining relative position with the handle 30. The introducer sheath assembly 10, having the sheath member 12, valve assembly 34, and dilator 20 axially locked via locking engagement, may be inserted into a patient. After dilating the intended endovascular delivery path, the dilator 20 may be removed while the sheath member 12 remains in place. The expander 20 can be completely removed by continuing to axially separate it from the handle 30.

[0070] In some embodiments, the dilator 20 includes a dilator tip 52 and a dilator body 54, wherein at least a portion of the diameter of the dilator tip 52 is larger than the diameter of the dilator body 54 (see [link to previous embodiment]). Figure 5 This facilitates the insertion of the introducer sheath assembly 10 without causing the sheath member 12 to be caught and held by tissue during travel. For example, when the sheath member 12 is in the delivery configuration, at least a portion of the dilator tip 52 may be flush with or have a diameter greater than that of the outer portion 24 of the sheath member 12. Both the front and rear ends of the dilator tip 52 may be tapered (e.g., curved tapered or straight tapered). The tapered front portion facilitates tissue dilation during insertion. Because the dilator tip 52 has a diameter similar to or greater than that of the outer portion 24 of the sheath member 12 when in the delivery configuration, the dilator tip 52 protects the sheath member 12 during insertion and reduces the likelihood of snagging and / or vascular trauma that may occur during insertion due to the front end of the sheath member 12. The dilator 20 can be removed from the lumen 21 of the sheath member 12. In embodiments with a larger diameter expander tip 52 and wherein the rear end of the expander tip 52 includes a tapered portion, the expander tip 52 can be used as a ramp surface to ensure that the expander tip 52 does not snag on the sheath member 12, thereby facilitating the removal of the expander 20 from the sheath member 12.

[0071] Reference Figure 5 In some embodiments, at least a portion of the inner portion 22 of the sheath member 12 is relatively stiffer (e.g., has greater rigidity) than the outer portion 24 of the sheath member 12. In these embodiments, the inner portion 22 may act as a one-piece reinforcement. The inner portion 22 may be stiffened by treating the material to increase rigidity and columnar strength, by adding components to increase rigidity (e.g., wire frames, etc.), or by being defined by the reinforcement 18. For example, in some embodiments, the inner portion 22 may be formed of a rigid material to which the outer portion 24 is coupled (e.g., end-to-end).

[0072] Now turn to the right Figure 3A and Figure 3B The discussion illustrates an assembly method with various components. The method of assembling the introducer sheath assembly 10 includes: an everted sheath member 12 such that the sheath member 12 defines an inner portion 22 and an outer portion 24, the inner portion 22 defining an inner cavity 21 through which an intracavitary device can travel, and the outer portion 24 surrounding at least a portion of the inner portion 22. The inner portion 22 is in... Figure 3AThe image shows a portion not surrounded by the outer portion 24 (e.g., the sheath member 12 is not flared outwards). The introducer sheath assembly 10 includes a first hub 14 coupled to an inner portion 22 of the sheath member 12 and a second hub 16 coupled to the outer portion 24 of the sheath member 12. The method includes inserting a reinforcement 18 between the inner portion 22 and the outer portion 24 of the sheath member 12, and inserting an expander 20 through the cavity 21. In some embodiments, the method includes joining the first hub 14 and the second hub 16 together.

[0073] Now go to Figures 4A to 4H The illustration shows an exemplary sequence of use for the introducer sheath. In some embodiments, an entry point near the vascular system 1000 is shown for entering the anatomical structure to provide the relative position of the components during use. This sequence is not necessarily performed in chronological order, as various reasons may require or facilitate certain steps to be performed in a different order than that shown herein. However, those steps that can be performed in a different order than that provided herein are within the scope of this disclosure. Furthermore, the components are not necessarily drawn to scale and may be provided so for clarity.

[0074] First refer to Figure 4A The image shows an inlet sleeve assembly 10 in its assembled configuration. The inlet sleeve assembly 10 includes a sleeve member 12, whose inner portion 22 and outer portion 24 are respectively coupled to a first hub 14 and a second hub 16; a reinforcement 18 positioned between the inner portion 22 and the outer portion 24; and an expander 20 extending through a cavity 21 of the sleeve member 12. A valve assembly 34 is also shown, which restricts fluid flow into and out of the body through the cavity 21, both when a component is positioned therethrough and when no positioning component is present in the cavity 21. A guidewire 60 is also shown.

[0075] Reference Figure 4B Once the introducer sheath assembly 10 is inserted into the patient to establish an insertion site, the dilator 20 can be removed from the introducer sheath assembly 10 to provide passage through the lumen 21, allowing other devices to be delivered through the sheath member 12. The reinforcement 18 can also be removed between the inner portion 22 and the outer portion 24 (however, in some embodiments, the reinforcement 18 may remain in place). With the dilator 20 removed, the lumen 21 is free (e.g., open and usable) and can be used to insert components through it, including components with a diameter greater than that of the sheath member 12, which can be accommodated by the sheath member 12 having an expansion diameter configuration as described above (again, the reinforcement 18 may also have an expansion diameter configuration according to some embodiments). It should also be understood that the sheath member 12, when in place with the vascular system, will not move longitudinally or remain longitudinally stationary along the surface in contact with the vascular system during use, meaning that once in place, the sheath member 12 will not slide longitudinally along or relative to the vascular system.

[0076] Reference Figure 4C The illustration shows an intraluminal device 100, constrained to the delivery diameter by a restraint member (not shown), being delivered through an introducer sheath assembly 10. The intraluminal device is carried on a catheter 102, both of which pass through the lumen 21. Figure 4D An intracavitary device 100 deployed into a delivery configuration is shown. Although shown adjacent to the introducer sheath assembly 10, it should be understood that the intracavitary device may be deployed away from the introducer sheath assembly 10, including locations further away from the introducer sheath assembly 10, since the introducer sheath assembly 10 acts as an insertion site.

[0077] Reference Figure 4E Once the intracavitary device 100 is deployed, in some embodiments, the reinforcement 18 can be reinserted to support the sheath member 12. This can be advantageous because the catheter 102 is being retracted through to limit snagging and pulling back of the sheath member 12. The reinforcement 18 provides columnar strength to resist being pulled out as the catheter 102 is withdrawn. Figure 4F The catheter 102 during removal is shown.

[0078] Reference Figure 4GOnce catheter 102 is removed and the procedure is nearing completion, the introducer sheath assembly 10 is ready for removal from the patient. During some procedures, including prolonged ones, the sheath member 12 may adhere to surrounding tissue. To limit shear forces and trauma to surrounding tissue, the first hub 14 is actuated away from the second hub 16. This results in a portion of the outer portion 22 of the sheath member 12 being everted inwards. This allows the sheath member 12 to be pulled away from the tissue without exerting shear forces (e.g., peeling). If reinforcement 18 is inserted, reinforcement 18 can be translated back along with the sheath member 12 during removal as it is everted inwards, with the transition portion 23 translating distally during removal. It should be understood that the transition portion 23 is not defined by a specific longitudinal position on the sheath member 12, but rather by the position where the sheath member 12 transitions from the inner portion 22 and the outer portion 24 during eversion and / or eversion, a position that moves as described herein. This arrangement allows the introducer sheath assembly 10, particularly the outer portion 24, to be removed from the vessel wall without sliding against it, but rather by peeling it off (e.g., moving it at an angle away from the vessel wall rather than translating it along it). This reduces potential trauma caused by adhesion of the outer portion 24 to the vessel wall. It should be understood that in some embodiments, the outer portion 24 can be inserted using a similar eversion arrangement, or it can be inserted into place using a sliding motion since adhesion has not yet occurred. In some embodiments, the space 25 can be pressurized or inflated to help break any adhesion between the sheath member 12 and the surrounding tissue. In some embodiments, fluid can be delivered through the outer portion 24 as described above, which can also limit adhesion or help break the adhesion between the sheath member 12 and the surrounding tissue. Figure 4H One embodiment is shown in which the reinforcement 18 is removed before the actuation of the second hub 16, causing the sheath member 12 to flip inward and outward.

[0079] In some embodiments, the sheath member 12 may generally be fluid-impermeable (unless otherwise stated). For example, the sheath member 12 may be made of a material that inhibits or reduces the passage of blood, bile, and / or other bodily fluids and materials through the sheath member 12. In some cases, the sheath member 12 has a material composition and construction that inhibits or prevents tissue from growing inward and / or endothelializing or epithelializing into the covering material.

[0080] Switch to Figures 6A to 6L The discussion illustrates an exemplary embodiment of the introducer sheath assembly 10 implemented in a patient's blood vessel for delivery of the endovascular device 100. (Refer to...) Figure 6A and Figure 6BThe diagram illustrates the insertion of an introducer sheath assembly 10 into a patient's vascular system 1000. The introducer sheath assembly 10 includes a sheath member 12 supported by a reinforcement 18 to provide columnar strength for insertion. The dilator 20 and sheath member 12 are inserted into the lumen of the blood vessel. Because the diameters of the dilator 20 and sheath member 12 are smaller than the diameter of the blood vessel, the likelihood of trauma to the blood vessel is reduced. Additionally, the introducer sheath assembly 10 is shown inserted from the side of the blood vessel but can be steered to pass through the vessel or provide access to the vessel for, for example, transcatheter procedures.

[0081] Figure 6C and Figure 6D The expansion 20 is shown being removed from the sheath members and hubs 14, 16. The expansion 20 is removed from the cavity 21 of the sheath member 12. This frees the cavity 21 (e.g., makes it open and usable), allowing additional components to be positioned through it, travel through it, or retract. Figure 6G and Figure 6H The illustration shows an intracavitary device 100 being delivered through the lumen 21 of a sheath member 12. As previously described, the sheath member 12 is capable of expanding its diameter as the component is positioned therein. In the embodiment shown herein, the expansion of the sheath member 12 causes it to contact the surrounding vascular system.

[0082] Figure 6I The illustration shows the intravascular device positioned at a target site for delivery. It should be understood that, in some embodiments, after the intravascular device 100 has been deployed, a portion of the sheath assembly 12 may be positioned between the intravascular device 100 and the vascular system. The introducer sheath assembly 10, as described herein, further facilitates removal from the vessel wall and from locations where the intravascular device and vascular system may be compressed. Figure 6J The introducer sheath assembly 10 is shown after the deployment of the intracavitary device 100 and its delivery system. Figure 6K and Figure 6L The removal of the sheath member 12 and the introducer sheath assembly 10 from the vascular system is illustrated. This is achieved by actuating the first hub to cause the sheath member 12 to fold inward and outward to peel off from the vascular system (if adhesion has occurred). This limits trauma to the vascular system during removal.

[0083] Go to Figures 7A to 7C The reinforcing member 18 can be configured in various ways. The reinforcing member 18 includes a first longitudinal edge 112 and a second longitudinal edge 114. The first longitudinal edge 112 and the second longitudinal edge 114 are defined substantially along the longitudinal direction of the reinforcing member 18, for example, substantially parallel to the longitudinal axis of the reinforcing member 18. Figure 7A A C-shaped configuration as described above is shown, wherein the first longitudinal edge 112 and the second longitudinal edge 114 are spaced apart from each other to define a gap. Figure 7BA spiral or open key ring construction is shown, wherein the first longitudinal edge portion and the second longitudinal edge portion adjacent to the first longitudinal edge 112 and the second longitudinal edge 114 respectively overlap each other, such that a portion of the reinforcement 18 comprises two layers. Figure 7B The reinforcement 18 includes a relaxed structure in which the first longitudinal edge 112 and the second longitudinal edge 114 extend beyond each other, such that the first longitudinal edge portion 113 and the second longitudinal edge portion 115 at least partially overlap. The reinforcement 18 is flexible, such that when a force is applied or a structure is positioned therebetween, the first longitudinal edge 112 and the second longitudinal edge 114 can deflect away from each other. Figure 7C It shows the relationship with Figure 7B The diagram shows a similar open key ring construction, and also includes a first angled edge 116 and a second angled edge 118. The reinforcement 18 includes a leading edge 110 and a first angled edge 116 extending between the leading edge 110 and a first longitudinal edge 112. The second angled edge 118 extends between the leading edge 110 and a second longitudinal edge 114. The first angled edge 116 and the second angled edge 118 define ramps configured to facilitate deflection and opening (e.g., expansion) of the reinforcement 18, allowing the reinforcement 18 to be more easily positioned around at least a portion of the sheath member 12 (e.g., around the inner portion 22 and within the space 25).

[0084] Now go to Figures 8A to 8C The handle 30 includes a port 32 that defines an internal opening to provide an entrance to the space 25 for inserting the reinforcement 18 (see also...). Figure 3A and Figure 4A The reinforcing member 18 can be inserted into and removed from the space 25 between the inner portion 22 and the outer portion 24 of the sheath member 12 via the port 32 in order to support the sheath member 12 (see...). Figure 6AIn some embodiments, the handle 30 includes a locator 120 configured to facilitate the placement of the reinforcement 18 around at least a portion of the sheath member 12. The locator 120 is configured to facilitate the orientation of the reinforcement 18 (e.g., positioning slit 44) to engage the sheath member 12. In some embodiments, the locator 120 is positioned adjacent to an internal opening and configured to position the reinforcement 18 around at least a portion of the circumference of the internal portion 22 of the sheath member 12. The locator 120 may include a first structure 122 coupled to the handle 30 via a second structure 124. The first structure 122 is sized at a first end 130 such that the internal space of the reinforcement 18 can be positioned around the first structure 122. The second structure 124 is narrow at the first end 130. The second structure 124 is configured to serve as an edge to facilitate the opening of the reinforcement 18 at the slit 44. The second structure 124 widens as it moves from the first end 130 toward the second end 132. Therefore, as the reinforcement 18 travels along the locator 120, the reinforcement 18 is further deflected open (e.g., the reinforcement 18 is expanded). The second structure 124 is wide enough at the interface between the sheath member 12 and the port 32 that the reinforcement 18 is transferred onto the sheath member 12 such that the reinforcement 18 extends at least partially around the circumference of the reinforcement 18 (e.g., inner portion 22). It should be noted that the first structure 122 may include a protrusion (e.g., a cone, not shown) to facilitate engagement and / or alignment of the reinforcement 18 with the first end 130 of the locator 120.

[0085] Figure 8A Positioner 120 is shown at the first end 130. Figure 8B A cross-section of the handle 30 at a position between the first end 130 and the second end 132 of the locator 120 is shown, illustrating the port 32 for deflection to insert the reinforcement 18 and the outline of the locator 120. Figure 8C The cross-section of the handle 30 at its second end 132, adjacent to the locator 120 and near the interface with the reinforcement 18 (not shown), is shown. This configuration allows the reinforcement 18 to snap around the sheath member 12. It can be understood that... Figure 7C The first angled edge 116 and the second angled edge 118 of the embodiment of the reinforcement 18 shown can be implemented together with the locator 120 such that when the reinforcement 18 is advanced into the port 32, the first angled edge 116 and the second angled edge 118 contact the second structure 124 to initiate deflection of the reinforcement (e.g., the first longitudinal edge 112 and the second longitudinal edge 114). In this way, the first angled edge 116 and the second angled edge 118 act as ramps to initiate deflection or expansion of the reinforcement 18. Figure 9 shows the reinforcement 18 positioned through the port 32, where the locator 120 is facilitating the opening, deflection, or spreading of the longitudinal edges 112, 114 of the reinforcement 14.

[0086] The sheath component 12 may include a fluoropolymer membrane, such as expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), or polyvinylidene acetate (PVDA). In other cases, the covering material includes polyolefins (e.g., polyethylene or expanded polyethylene), polyesters, silicones, polyurethanes, biocompatible polymers, polyethylene terephthalate (e.g., Dacron®), copolymers, or combinations thereof. These are provided by way of example only and should not be considered as limitations on the materials that can be implemented.

[0087] The sheath member 12 (or a portion thereof) may also be modified by one or more chemical or physical processes that enhance one or more properties, including modification with a coating. For example, a hydrophilic coating may be applied to the sheath member 12 to improve the wettability and echogenicity of the covering. In some cases, the sheath member 12 or a portion thereof may be modified with chemical components that promote one or more biological responses, anti-adhesion, and antithrombotic properties. In some cases, the sheath member 12 or a portion thereof may be modified to resist biofouling. Furthermore, the sheath member 12 or a portion thereof may be modified with one or more covalently attached pharmaceutical substances (e.g., heparin, antibiotics, etc.) or impregnated with one or more pharmaceutical substances. The pharmaceutical substances may be released in situ to promote healing, reduce tissue inflammation, reduce or inhibit infection, reduce vasoconstriction or vasospasm, and promote various other therapeutic treatments and outcomes. In some embodiments, the pharmaceutical substances may be, but are not limited to, corticosteroids, human growth factors, antimitotic agents, antithrombotic agents, stem cell materials, or dexamethasone sodium phosphate. Additionally, pharmacological agents may be delivered separately from the sheath member 12 to the insertion site to promote tissue healing or tissue growth.

[0088] The invention of this application has been described above from a general perspective and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, it is intended that these embodiments cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. An introducer sheath assembly, comprising: A sheath member operable to fold inward or outward, the sheath member defining an inner cavity, the sheath member having at least one of the following material properties: drape, conformability, and low bending stiffness. as well as A reinforcement member configured to removably engage and support the sheath member, the reinforcement member having a stiffness relatively greater than that of the sheath member.

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

3. The introducer sheath assembly according to claim 1 or 2, characterized in that, Also includes: An expander, the expander being removably positioned within the cavity of the sheath member; as well as A hub connected to the sheath member, wherein when the hub is actuated, the hub is operable to cause at least a portion of the sheath member to fold inward and outward.

4. An introducer sheath for introducing a transcatheter assembly into a patient, the introducer sheath comprising: A sheath member comprising an inner portion and an outer portion, the inner portion defining an inner cavity through which an internal device can extend longitudinally, and the outer portion surrounding at least a portion of the inner portion; as well as Handle, the handle comprising: A first hub, the first hub being connected to the inner portion of the sheath member; and The second hub is connected to the outer portion of the sheath member. When the first hub moves away from the second hub, a portion of the length of the sheath member positioned on the outer portion is transferred from the outer portion to the inner portion.

5. The introducer sheath according to claim 4, characterized in that, It also includes a reinforcement configured to be positioned between the inner portion and the outer portion of the sheath member.

6. The introducer sheath according to claim 5, characterized in that, The reinforcement is an elongated member that defines an inner cavity and defines a slit along at least a portion of the longitudinal length of the reinforcement.

7. The introducer sheath according to any one of claims 5-6, characterized in that, The reinforcing member is relatively stiffer than the sheath member, wherein the sheath member has at least one of the following material properties: drape, conformability, and low bending stiffness.

8. The introducer sheath according to any one of claims 5-7, characterized in that, The sheath member is configured to accommodate a component having a diameter greater than that of the reinforcement.

9. The introducer sheath according to any one of claims 5-8, characterized in that, It also includes an inlet handle, which includes a valve, through which the sheath member extends.

10. The introducer sheath according to claim 9, characterized in that, The inlet handle includes a port through which the reinforcement extends.

11. The introducer sheath according to claim 10, characterized in that, The internal opening of the port is aligned to provide an entrance to the space between the first hub and the second hub.

12. The introducer sheath according to any one of claims 5-11, characterized in that, At least a portion of the inner portion of the sheath member is relatively harder than the outer portion of the sheath member.

13. The introducer sheath according to any one of claims 5-12, characterized in that, At least a portion of the inner portion of the sheath component includes an integral reinforcement.

14. The introducer sheath according to any one of claims 5-13, characterized in that, At least a portion of the outer portion of the sheath member includes a hole through which at least one of fluid and therapeutic agent is deliverable.

15. The introducer sheath according to claim 5, characterized in that, The reinforcement defines a first longitudinal edge portion adjacent to a first longitudinal edge and a second longitudinal edge portion adjacent to a second longitudinal edge, wherein the first longitudinal edge portion and the second longitudinal edge portion at least partially overlap to define the open key ring outline of the reinforcement.

16. The inlet sleeve according to claim 15, characterized in that, The reinforcement includes a leading edge, a first angled edge extending between the leading edge and the first longitudinal edge, and a second angled edge extending between the leading edge and the second longitudinal edge.

17. The introducer sheath according to claim 5, characterized in that, The handle includes a port configured to receive the reinforcement, wherein the port defines an internal opening, and wherein the handle defines a locator positioned adjacent to the internal opening, the locator being configured to position the reinforcement around at least a portion of the circumference of the inner portion of the sheath member.

18. The introducer sheath according to claim 17, characterized in that, The positioner includes a first structure coupled to the second structure, wherein the first structure is sized at a first end such that the reinforcement can be positioned around the first structure.

19. The inlet sleeve according to claim 18, characterized in that, The sheath component is operable to invert during removal from the blood vessel.

20. The inlet sleeve according to claim 19, characterized in that, The sheath component is operable to translate into the blood vessel during insertion or evert into the blood vessel during insertion.

21. A delivery system comprising the introducer sheath of claim 4 and further comprising: An expander, the expander being positioned within the cavity defined by the inner portion of the sheath member; as well as An intraluminal device, positioned on a catheter and constrained to a delivery diameter by a restraining member, wherein the inner portion of the sheathing member has a diameter larger than the delivery diameter of the intraluminal device, such that the intraluminal device can move longitudinally through the sheathing member.

22. A method for assembling an introducer sheath, comprising: An outward or inward folding sheath member, such that the sheath member defines an inner portion and an outer portion, the inner portion defining an inner cavity through which an internal device can travel, the outer portion surrounding at least a portion of the inner portion, wherein a first hub is connected to the inner portion of the sheath member and a second hub is connected to the outer portion of the sheath member; as well as The reinforcing member is inserted between the inner and outer portions of the sheath member.

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