Sheath HUB assembly

Abstract

Disclosed herein are introducer sheaths and methods of using the same. The system can include an expandable sheath, a sheath locking nut for securing the expandable sheath to a sheath hub, a support sleeve received within the sheath locking nut, the support sleeve for providing a support surface for the expandable sheath and including a central lumen coaxial with the central lumen of the sheath locking nut, and an anchor provided within the central lumen of the sheath locking nut for providing a compressive force against the expandable sheath when received within the central lumen of the sheath locking nut, the anchor securing the expandable sheath between the sheath locking nut and the support sleeve.

Description

SHEATH HU B ASSEM BLYRELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 622,378, filed January 18, 2024, entitled "SHEATH HUB ASSEMBLY," the contents of which are incorporated by reference in their entirety for all purposes.TECHNICAL FIELD

[0002] The present application is directed to an expandable 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's vasculature.BACKGROUND OF THE INVENTION

[0003] Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as a prosthetic valve, at locations inside the body that are not readily accessible by surgery or where access without 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.

[0004] Percutaneous interventional medical procedures utilize the large blood vessels of the body to reach target destinations rather than surgically opening a target site. There are many types of diseases or states that can be treated via interventional methods including coronary blockages, valve replacements (TAVR) and brain aneurysms. These techniques involve using wires, catheters, balloons, electrodes and other thin devices to travel down the length of the blood vessels from the access site to the target site. The devices have a proximal end which the clinician controls outside of the body and a distal end inside the body, which is responsible for treating the disease state.Percutaneous interventional procedures offer several advantages over open surgical techniques. First, they require smaller incision sites, which reduces scarring and bleeding as well as infection risk. Procedures are also less traumatic to the tissue, so recovery times are reduced. Finally, interventional techniques can usually be performed much faster, and with fewer clinicians participating in the procedure, so overall costs are lowered. In some cases, the need for anesthesia is also eliminated, further speeding up the recovery process and reducing risk.

[0005] A single procedure typically uses several different guidewires, catheters, and balloons to achieve the desired effect. One at a time, each tool is inserted and then removed from the access site sequentially. For example, a guidewire is used to track to the correct location within the body. Next a balloon may be used to dilate a section of narrowed blood vessel. Last, an implant may bedelivered to the target site. Because catheters are frequently inserted and removed, introducer sheaths are used to protect the local anatomy and simplify the procedure.

[0006] An introducer sheath can be used to safely introduce a delivery apparatus into a patient's vasculature (for example, the femoral artery). Introducer sheaths are conduits that seal onto the access site blood vessel to reduce bleeding and trauma to the vessel caused by catheters with rough edges. 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. Once the introducer sheath is positioned within the vasculature, the shaft of the delivery apparatus is advanced through the sheath and into the vasculature, carrying the prosthetic device. Expandable introducer sheaths, formed of highly elastomeric materials, allow for the dilating of the vessel to be performed by the passing prosthetic device.

[0007] Introducer sheaths are typically coupled at their proximal end to a hub system, housing, or handle assembly. The hub / handle provides various access ports to the sheath as well as a handle for the sheath assembly. Generally, the sheath is coupled to the hub / handle by a mechanical and / or chemical fastener including, for example, a compression fit or adhesive between the sheath and various hub / handle. However, these coupling methods have been found to cause damage to the introducer sheath that can result in complete system failure. Accordingly, there remains a need for improvements in the hub / handle assemblies and corresponding methods of coupling to expandable introducer sheaths for endovascular systems used to implant valves and other prosthetic devices.SUMMARY OF THE INVENTION

[0008] Aspects of the present expandable sheath and hub / handle assembly can minimize damage to the sheath and medical device by improving bonding between the sheath and the sheath hub / handle assembly. Aspects ensure that neither the sheath nor blood vessel are damaged during efforts to advance the medical device therethrough. Furthermore, certain implementations can reduce the length of time a procedure takes.

[0009] In one of its basic configurations, the present disclosure provides a sheath system for deploying a medical device including a reinforced proximal end portion where the sheath is coupled to a sheath hub assembly. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0010] In some implementations, the techniques described herein relate to a system for connecting an expandable sheath to a sheath hub including: an expandable sheath; a sheath locking nut for securing the expandable sheath to a sheath hub, the sheath locking nut including a central lumen extending therethrough; a support sleeve received within the sheath locking nut, the support sleeve for providing a support surface for the expandable sheath and including a central lumen coaxial with the central lumen of the sheath locking nut; and an anchor provided within the central lumen of the sheath locking nut for providing a compressive force against the expandable sheath when received within the central lumen of the sheath locking nut, the anchor securing the expandable sheath between the sheath locking nut and the support sleeve.

[0011] In some implementations, the techniques described herein relate to a connector system for connecting an expandable sheath to a sheath hub including: a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut, at least a portion of the anchor extending toward a longitudinal axis of the sheath locking nut.

[0012] In some implementations, the techniques described herein relate to a method of securing a delivery sheath to a sheath hub using a connector system, the method including: providing an expandable sheath; providing a sheath hub assembly including: a sheath hub; a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut; positioning the support sleeve adjacent the distal end of the sheath hub such that the anchor is located between the sheath locking nut and the support sleeve; advancing the support sleeve with the central lumen of the sheath locking nut such that a portion of the body portion extends through and beyond a distal opening of the sheath locking nut; advancing a proximal end of the expandable sheath over the portion of the body portion extending through the distal opening of the sheath locking nut; advancing the proximal end of theexpandable sheath into the central lumen of the sheath locking nut and over the body portion; coupling the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub; and further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub causing the anchor to provide a compressive force against an outer surface of the expandable sheath, thereby securing the expandable sheath between the sheath locking nut and the support sleeve and fixing an axial position of the expandable sheath with respect to at least one of the sheath locking nut or the support sleeve.

[0013] In some implementations, the techniques described herein relate to a method of delivering a medical device, the method including: providing an expandable sheath; providing a sheath hub assembly including: a sheath hub; a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut; positioning the support sleeve adjacent the distal end of the sheath hub such that the anchor is located between the sheath locking nut and the support sleeve; advancing the support sleeve with the central lumen of the sheath locking nut such that a portion of the body portion extends through and beyond a distal opening of the sheath locking nut; advancing a proximal end of the expandable sheath over the portion of the body portion extending through the distal opening of the sheath locking nut; advancing the proximal end of the expandable sheath into the central lumen of the sheath locking nut and over the body portion; coupling the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub; further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub causing the anchor to provide a compressive force against an outer surface of the expandable sheath, thereby securing the expandable sheath between the sheath locking nut and the support sleeve and fixing an axial position of the expandable sheath with respect to at least one of the sheath locking nut or the support sleeve; inserting the expandable sheath at least partially into the blood vessel of the patient; advancing the distal end of the sheath to the treatment site; advancing a medical device through the central lumen of the sheath to the treatment site; locally expanding the sheath from an initial condition / diameter to a locally expanded condition / diameter by the outwardly directed radial force of the medical device; locally contractingthe sheath from the locally expanded condition at least partially back to the initial condition using inwardly directed radial force an elastic feature of the sheath; and delivering the medical device to the treatment site.

[0014] Various aspects of the examples described above can be combined based on desired sheath system and sheath hub assembly characteristics.BRIEF DESCRIPTION OF DRAWINGS

[0015] FIG. 1 is an elevation view of an expandable sheath along with an endovascular delivery apparatus for implanting a prosthetic implant.

[0016] FIG. 2 is an elevation view of an expandable sheath, sheath locking sleeve, and introducer.

[0017] FIG. 3 is an elevation view of the expandable sheath of FIG. 2 along with an endovascular delivery apparatus / delivery catheter for implanting a prosthetic implant.

[0018] FIG. 4 is an elevation view of the expandable sheath, sheath hub, introducer hub, and sheath locking sleeve of FIG. 2.

[0019] FIG. 5A is a partial cross-sectional view of the sheath, sheath hub, sheath locking sleeve, introducer locking hub, and introducer of FIG. 2.

[0020] FIG. 5B is a partial cross-sectional view of the sheath, sheath hub, sheath locking sleeve, introducer locking hub, and introducer of FIG. 2.

[0021] FIG. 6 is a cross-sectional view of the sheath hub, sheath locking sleeve, and introducer locking hub of FIG. 2.

[0022] FIG. 7 is a perspective view of a sheath hub assembly according to another example.

[0023] FIG. 8 is a cross-sectional view of the sheath hub assembly of FIG. 7.

[0024] FIG. 9 is a partial cross-sectional view of the sheath hub assembly of FIG. 8 with the sheath attached.

[0025] FIG. 10 is an exploded view of the sheath hub assembly of FIG. 7.

[0026] FIG. 11 is a side view of an example anchor.

[0027] FIG. 12 is a front view of the anchor of FIG. 11.

[0028] FIG. 13 is a side view of the anchor of FIG. 11.

[0029] FIG. 14 is a perspective view of the anchor of FIG. 11.

[0030] FIG. 15 is a perspective view of the sheath hub assembly of FIG. 7, without the sheath locking cap.

[0031] FIG. 16 is a side view of the sheath hub assembly of FIG. 7, without the sheath locking cap.DETAILED DESCRIPTION OF THE INVENTION

[0032] 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, implementations, 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.

[0033] For purposes of this description, certain aspects, advantages, and novel features of the aspects 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 aspects, 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.

[0034] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect or example of the present disclosure are to be understood to be applicable to any other aspect 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 present disclosure is not restricted to the details of any foregoing aspects. The present disclosure 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.

[0035] 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.

[0036] 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.

[0037] "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.

[0038] The terms "proximal" and "distal" as used herein refer to regions of a sheath, catheter, or delivery assembly. "Proximal" means that region closest to handle of the device, while "distal" means that region farthest away from the handle of the device.

[0039] "Axially" or "axial" as used herein refers to a direction along the longitudinal axis of the sheath.

[0040] 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.

[0041] Example expandable introducer sheaths are disclosed, for example, in U.S. Patent No. 8,690,936, entitled "Expandable Sheath for Introducing an Endovascular Delivery Device into a Body," U.S. Patent No. 8,790,387, entitled "Expandable Sheath for Introducing an Endovascular Delivery Device into a Body," U.S. Patent No. 10,639,152, entitled "Expandable Sheath and Methods of Using the Same," U.S. Patent No. 10,792,471, entitled "Expandable Sheath," U.S. Patent No.Application No. 16 / 407,057, entitled "Expandable Sheath with Elastomeric Cross Sectional Portions," U.S. Patent No. 10,327,896, entitled "Expandable Sheath with Elastomeric Cross Sectional Portions," U.S. Patent No. 11,273,062, entitled "Expandable Sheath," Application No. PCT / US2021 / 019514, entitled "Expandable sheath for introducing an endovascular delivery device in to a body," Application No. PCT / US2021 / 031227, entitled "Expandable sheath for introducing an endovascular delivery device into a body," Application No. PCT / US2021 / 031275, entitled "Expandable sheath for introducing an endovascular delivery device into a body," U.S. Application No. 17 / 113,268, entitled "Expandable Sheath and Method of Using the Same," Application No. PCT / US2021 / 058247, entitled"Self-Expanding, Two Component Sheath," Application No. PCT / US2022 / 012785, entitled "Expandable Sheath," U.S. Patent No. 11,051,939, entitled "Active Introducer Sheath System," Application No. PCT / US2022 / 012684, entitled "Introducer with Sheath Tip Expander," U.S. Application No. 17 / 078,556, entitled "Advanced Sheath Patterns," Application No. PCT / US2021 / 025038, entitled "Low temperature hydrophilic adhesive for use in expandable sheath for introducing an endovascular delivery device into a body," Application No. PCT / US2021 / 050006, entitled "Expandable Sheath Including Reversible Bayonet Locking Hub," Application No. PCT / US2022 / 049968, entitled "Expandable Sheath Gasket to Provide Hemostasis," U.S. Provisional Application No. 63 / 530,144, entitled "Introducer / Dilator with Folded Balloon," and U.S. Provisional Application No. 63 / 502,907, entitled "Lead Screw Driven Sheath Dilator," the disclosures of which are herein incorporated by reference.

[0042] The expandable introducer sheaths and related componentry described herein can be used to deliver a prosthetic device through a patient's vasculature to a procedure site within the body. Disclosed introducer sheaths that are particularly suitable for delivery of implants in the form of implantable heart valves, such as balloon-expandable implantable heart valves. Balloon-expandable implantable heart valves are well-known and will not be described in detail here. An example of such an implantable heart valve is described in U.S. Patent No. 5,411,552, and also in U.S. Patent No.9,393,110, both of which are hereby incorporated by reference. The expandable introducer sheaths disclosed herein may also be used to deliver other types of implantable medical device, such as selfexpanding and mechanically expanding implantable heart valves, stents or filters. Beyond transcatheter heart valves, the introducer sheath system can be useful for other types of minimally invasive surgery, such as any surgery requiring introduction of an apparatus into a subject's vessel. For example, the introducer sheath system can be used to introduce other types of delivery apparatus for placing various types of intraluminal devices (for example, stents, stented grafts, balloon catheters for angioplasty procedures, etc.) into many types of vascular and non-vascular body lumens (for example, veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.). The term "implantable" as used herein is broadly defined to mean anything - prosthetic or not - that is delivered to a site within a body. A diagnostic device, for example, may be an implantable.

[0043] FIG. 1 illustrates an exemplary sheath 8 in use with a representative delivery apparatus 10, for delivering an implant 12, or other type of implantable (for example, tissue heart valve), to a patient. The delivery apparatus 10 can include a steerable guide catheter 14 (also referred to as a flex catheter) and a balloon catheter 16 extending through the guide catheter 14, and a nose catheter 17 extending through the balloon catheter 16. The guide catheter 14, balloon catheter 16,and nose catheter 17 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the implant 12 at an implantation site in a patient's body as described in detail herein.

[0044] As described in more detail herein, in general, the sheath 8 comprises an elongate expandable tube that, in use, is inserted into a vessel (for example, transfemoral vessel, femoral artery, iliac artery) by passing through the skin of the patient, such that the distal end of the sheath 8 is inserted into the vessel. The sheath 8 includes a hemostasis valve and / or sealing features at the proximal end of the sheath 8, for example, in the sheath hub 20, that provides hemostasis and prevents blood leakage from the patient through the sheath 8. The sheath 8, including an introducer 6, is advanced into the patient's vasculature. Once positioned the introducer 6 is removed and the delivery apparatus 10 is inserted into / through the sheath 8, and the prosthetic device (implant 12) then be delivered and implanted within patient.

[0045] FIG. 2 illustrates a side view of the sheath assembly with the introducer 6 received within the central lumen 9 of the sheath 8 for placement within the patient's blood vessel. FIG. 3 illustrates a side view of the sheath assembly with the introducer 6 removed and the balloon catheter 16 advanced within the central lumen 9 of the sheath 8. As shown in FIGS. 2 and 3, the sheath assembly includes a sheath hub 20 at a proximal end of the device and the expandable sheath 8 extending distally from the sheath hub 20.

[0046] FIG. 4 is an enlarged side view of the proximal end of the sheath assembly of FIG. 2. FIGS. SA and SB provide side cross sectional views of the portion of the sheath assembly illustrated in FIG. 4 (FIG. 5B shows a cross-sectional view of the sheath assembly rotated 90 degrees around the longitudinal axis of the sheath 8 compared to the cross-sectional view shown in FIG. 5A). FIG. 6 provides a cross-sectional side view of the sheath hub 20, excluding the elongated introducer 6 and seal assembly shown in FIGS. 5A and 5B.

[0047] FIGS. 2 and 4-6 illustrate the sheath assembly including a sheath locking system 18 for removably coupling the introducer 6 and sheath 8, particularly, for coupling the introducer locking hub 30 with the sheath hub 20 during sheath insertion into the patient. When the introducer locking hub 30 is coupled to the sheath hub 20, axial and rotational movement of the introducer 6 with respect to the sheath 8 is limited. That is, during insertion into the patient, having the sheath locking system 18 engaged fixes the introducer 6 with respect to the sheath 8 without requiring a physician or technician to hold the introducer 6 and the sheath 8 in place / together at their distal end. The sheath locking system 18 keeps the introducer 6 from separating from the sheath 8 and prevents gaps from forming that can cause patient abrasions and unintended fluid flow between the introducer 6 and the sheath 8 when advanced through the patient's blood vessel.

[0048] Example locking systems are disclosed in PCT / US2021 / 050006, entitled "Expandable Sheath Including Reverse Bayonet Locking Hub," the disclosure of which is incorporated herein by reference. It is contemplated that the locking system 18 disclosed herein can also be used to couple the sheath 8 / sheath hub 20 with other delivery apparatus components, catheters, dilators, etc. including the same mating features.

[0049] As illustrated in FIGS. 2 and 4-6, the sheath locking system 18 includes a locking sleeve 28 that couples the sheath hub 20 to the introducer locking hub 30. As provided in FIGS. 5A-6, the distal end of the locking sleeve 28 is received within a portion of the central lumen of the sheath hub 20. The sheath hub 20 includes receiving slots 48 / openings which extend around a portion of the diameter of the sheath hub 20 and are sized and configured to accept a projection (interference diameters 66) that extend radially from the locking sleeve 28. Coupling between the receiving slots 48 and the interference diameters 66 axially and rotationally fixes the locking sleeve 28 and the sheath hub 20 relative to each other.

[0050] As illustrated, for example, in FIGS. 4-6, the locking sleeve 28 includes an elongated sleeve body 29 with a central lumen 56 extending longitudinally between the proximal end and distal end of the sleeve body 29. As provided in FIG. 6, the central lumen 56 defines a generally cylindrical inner surface 62 of the sheath locking sleeve 28. The distal end of the sleeve body 29 also has a frustoconical outer surface 64 that tapers about the distal end to help with positioning the locking sleeve 28 within the central lumen of the sheath hub 20 and abutting the seal assembly 24 (FIGS. 5A- 5B). The locking sleeve 28 includes a plurality of interference diameters 66 that extend radially from the outer surface of the sleeve body 29 around (all or a portion of) the circumference of the locking sleeve 28. As illustrated in FIG. 4 and 6, the interference diameters 66 are sized and configured to engage corresponding recesses and / or receiving slots 48 provided in the sheath hub 20 for securing the locking sleeve 28 to the sheath hub 20. The locking sleeve 28 also includes a shoulder at its proximal end for seating against the proximal end of the sheath hub 20.

[0051] The locking sleeve 28 includes a guide 31 projecting from the outer surface 68 of the locking sleeve 28. The guide 31 engages a corresponding shaped locking channel 38 (FIG. 2) in the introducer locking hub 30, as shown, for example, in FIG. 2. The guide 31 extends radially from the outer surface 68 and at least partially around the circumference of the outer surface 68.

[0052] FIGS. 5A-5B illustrate the introducer 6 with the introducer locking hub 30 coupled to its proximal end. As illustrated in FIG. 2, when the introducer locking hub 30 is coupled to the sheath hub 20, the introducer 6 extends through the central lumen of the locking sleeve 28, sheath hub 20, and the sheath 8. The introducer 6 is formed as an elongated body with a central lumen extending therethrough. In some examples, the proximal end of the introducer 6 is received within a recessedopening 39 provided in the introducer locking hub 30, where the recessed opening 39 is axially aligned with the central lumen 40 of the introducer locking hub 30. The introducer 6 can be removably and / or fixedly coupled to the introducer locking hub 30 at the recessed opening 39. When assembled / coupled, the central lumen of the introducer 6 is aligned with the central lumens of the introducer locking hub 30, sheath hub 20, and the sheath 8, as illustrated in FIGS. 5A-5B. This joined / continuous lumen allows for the passage of surgical equipment and / or medical devices to the treatment site (for example, a guide wire).

[0053] The introducer locking hub 30 is provided at and engages the proximal end of the locking sleeve 28 and is moveable between a locked and unlocked position, thereby fixing the position of the introducer 6 and the sheath 8 and preventing movement therebetween. As illustrated in FIGS. 2 and SA-6, the locking sleeve 28 includes a guide 31 that engages a locking channel 38 provided on the introducer locking hub 30. The guide 31 is movable within the locking channel 38 between an unlocked position, where the locking sleeve 28 is rotationally and axially movable with respect to the introducer locking hub 30, and a locked position (shown in FIG. 2), where the locking sleeve 28 is axially fixed with respect to the introducer locking hub 30. The locking channel 38 be is formed as recess or groove in a surface of the introducer locking hub 30, as a slotted opening, a clip, or as any other feature capable of receiving and securing the guide 31 projecting from the outer surface of the locking sleeve 28 with the introducer locking hub 30.

[0054] The introducer locking hub 30 includes a hub body 32 defining a central lumen 45 extending therethrough. As described herein, the distal portion of the central lumen 45 defines the recessed opening 39 for receiving and retaining the introducer 6. As illustrated in FIG. 6, when coupled, the proximal end of the locking sleeve 28 is received within a distal portion of the central lumen 45 of the introducer locking hub 30. For example, when the locking sleeve 28 and introducer locking hub 30 are coupled, at least a portion of the sleeve body 29 of the sheath locking sleeve 28 is received within the larger diameter portion of the central lumen 45 of the introducer locking hub 30. As illustrated in FIG. 6, when coupled, the proximal end surface of the locking sleeve 28 is adjacent and / or abuts a shoulder 50 provided on an inner surface of the central lumen 45 of the introducer locking hub 30. As provided in FIG. 6, the proximal portion 37 of the central lumen 45 includes the decreasing taper portion 41 for guiding medical device into the central lumen 45.

[0055] As described herein, the sheath locking system 18 facilitates coupling the introducer 6 with the sheath 8, particularly by coupling the introducer locking hub 30 with the sheath hub 20. In turn, the sheath 8 is coupled to the sheath assembly at the sheath hub 20. The sheath hub 20 can also function as a handle for the sheath assembly / delivery apparatus 10. As illustrated in FIGS. 5A and 5B, the sheath hub 20 also provides a housing for necessary seal assemblies and an access point for asecondary lumen (for example, fluid lumen) in fluid communication with the central lumen of the sheath hub 20 and / or the central lumen 9 of the sheath 8. As shown in FIGS. 5A and 5B, the seal assembly included in the sheath hub 20 includes a proximal seal 24a, an intermediate seal 24b, and a distal seal 24c. When assembled, the introducer 6 passes through the seal assembly and extends through the distal opening of the sheath 8. The proximal seal 24a, the intermediate seal 24b, and the distal seal 24c are each formed to prevent unwanted fluid from advancing in the proximal direction through the sheath hub 20.

[0056] As illustrated in FIGS. 5A-6, the sheath 8 is coupled to the distal end of the sheath hub 20 via compression fit between the sheath hub 20 and the sheath locking nut 22. The sheath hub assembly 100 described herein in reference to FIGS. 7-16 optimizes engagement between the expandable sheath 8 and the sheath hub 20, preventing the sheath 8 from separating from the sheath hub 20 while also preventing damage to the proximal end of the sheath 8.

[0057] In some example sheath systems, it has been found that the proximal end of the sheath 8 is susceptible to radial cracking in response to compression of the sheath 8 between the sheath hub 20 and the sheath locking nut 22. The potential for radial cracking is compounded due to changes in the sheath 8 material properties due to heat-bonding in the manufacturing process, sterilization of the sheath 8, and the general aging process of the sheath materials. The sheath hub assembly 100 of the present disclosure helps to prevent radial cracking, improve circularity of the sheath, ensure that the proximal end of the sheath has an even thickness, and improve bonding of the between the inner and outer layers of the sheath. The present example also helps to ensure the engagement between the sheath 8, sheath locking nut 22, and sheath hub 20.

[0058] FIGS. 7-16 illustrate various components of the example sheath hub assembly 100. The example sheath hub assembly 100 includes similar features and structure to the sheath hub 20 and sheath locking nut 22 provided in FIGS. 1-6. The differences between the sheath hub 20 of FIGS. 1-6 and the sheath hub 110 of FIGS. 7-17 are provided herein.

[0059] FIG. 7 provides a side perspective view of the example sheath hub assembly 100. FIG. 8 is a cross-sectional view of the sheath hub assembly 100 of FIG. 7 taken along the longitudinal axis of the assembly. FIG. 9 is a partial cross-sectional view of sheath hub assembly 100 of FIG. 8 with the sheath 8 attached. FIG. 10 provides an exploded view of the example sheath hub assembly 100, and FIGS. 15 and 16 show perspective and side views of the sheath hub assembly 100 without the sheath locking nut 120.

[0060] Similar to the sheath assembly of FIGS. 1-6, the sheath hub assembly 100 of FIG. 7 includes a sheath hub 110 and a sheath locking nut 120 for coupling the sheath 8 to the sheath hub 110. In some examples, the sheath hub 110 corresponds in size and shape to the sheath hub 20 of FIGS. 1-6.

[0061] As described in more detail herein, the sheath hub assembly 100 further includes a support sleeve 130 and an anchor 140. The proximal end of the sheath 8 is received on the support sleeve 130 and, as the sheath locking nut 120 is tightened onto the sheath hub 110, the anchor 140 is compressed into the sheath 8 securing the expandable sheath 8 between the sheath locking nut 120 and the support sleeve 130. This coupling prevents the sheath 8 from separating from the sheath hub 110 while also avoiding damage to the proximal end of the sheath 8. As described herein, the sheath hub assembly 100 includes sealing members provided between the sheath locking nut 120 and the support sleeve 130, and spacers for positioning the sealing members and anchor 140 along the support sleeve 130. In some examples, the sealing members and spacers, in combination with the sheath locking nut 120 and anchor 140, help secure the sheath 8 to the support sleeve 130 while also ensuring hemostasis between the sheath 8 and the sheath hub 110.

[0062] As illustrated in FIGS. 8 and 9, the support sleeve 130 is provided at the distal end 116 of the sheath hub 110. The support sleeve 130 includes a central lumen 132 extending therethrough. The central lumen 132 of the support sleeve 130 is aligned with the central lumen 112 of the sheath hub 110, the central lumen 122 of the sheath locking nut 120, and the central lumen 9 of the sheath 8. As illustrated in FIG. 8, when assembled, the support sleeve 130 is received within the central lumen 122 of the sheath locking nut 120. In some examples, when assembled, the distal end 134 of the support sleeve 130 extends beyond the distal end of the sheath locking nut 120 providing a support surface for the proximal end of the expandable sheath 8.

[0063] As provided in FIG. 9, support sleeve 130 includes an elongated body portion 133 extending between the distal end 134 of the support sleeve 130 to a shoulder 135 projecting radially outward from the body portion 133. The shoulder 135 extends between the body portion 133 and a larger diameter collar 136 provided adjacent a proximal end 137 of the support sleeve 130. The shoulder 135 extends from the body portion 133 toward the proximal end 137 of the support sleeve 130 in a direction transverse to the longitudinal axis of the support sleeve 130. In some examples, the shoulder 135 extends at an obtuse angle measured between the body portion 133 and the outer surface of the shoulder 135. In some examples, the angle of the shoulder 135 corresponds to the angle of the tapered proximal end surface 182 of the proximal spacer 180 described herein, such that the proximal end surface 182 of the proximal spacer 180 abuts the shoulder 135.

[0064] In some examples, as illustrated in FIG. 9, the outer surface 138 of the support sleeve 130 provides a support surface for the proximal end of the expandable sheath 8. As shown in FIGS. 8-9, the outer surface 138 of the body portion 133 of the support sleeve 130 has an increasing taper extending from the distal end 134 toward the proximal end 137 of the support sleeve 130. In some examples, the diameter of the outer surface 138 at the proximal end of the body portion 133 and / orproximal end 137 of the support sleeve 130 is greater than the diameter of the outer surface 138 at the distal end 134 of the support sleeve 130.

[0065] Similarly, in some examples, the inner surface 139 of the body portion 133 of the support sleeve 130 has an increasing taper extending from the distal end 134 toward the proximal end 137 of the support sleeve 130. In some examples, the inner diameter of the inner surface 139 at the distal end 134 of the support sleeve 130 is less than the inner diameter of the inner surface 139 at the proximal end of the body portion 133 and / or the proximal end 137 of the support sleeve 130.

[0066] As described herein, the sheath hub assembly 100 includes an anchor 140 for providing compressive force against the expandable sheath 8. The anchor 140 is positioned within the sheath locking nut 120 and along the support sleeve 130 between a first distal spacer 150 and the second distal spacer 160. In some examples, the first distal spacer 150 and second distal spacer 160 fix the axial position of the anchor 140 with the sheath locking nut 120 / along the support sleeve 130, such that the anchor 140 can similarly fix the position of the expandable sheath 8 when received between the anchor 140 and the support sleeve 130.

[0067] As provided in FIGS. 8-9, when assembled, the first distal spacer 150 is received within the central lumen 122 of the sheath locking nut 120 and around the body portion 133 of the support sleeve 130 at a location adjacent the distal end of the sheath locking nut 120. The second distal spacer 160 is similarly received within the central lumen 122 of the sheath locking nut 120 and around the body portion 133 of the support sleeve 130 as a location proximal the first distal spacer 150. That is, as provided in FIG. 8, the first distal spacer 150 is positioned between the second distal spacer 160 and the distal end of the sheath locking nut 120.

[0068] The first distal spacer 150 includes an elongated annular-shaped body that extends around the support sleeve 130. As illustrated in FIG. 9, when assembled, the distal end surface 152 of the first distal spacer 150 abuts a first shoulder 123 provided on the central lumen 122 of the sheath locking nut 120. In some examples, the proximal end surface 154 of the first distal spacer 150 defines a tapered surface. The tapered surface / proximal end surface 154 extends in a direction transverse to the longitudinal axis of the first distal spacer 150 from the inner surface 156 of the first distal spacer 150 in a direction toward the distal end of the first distal spacer 150. In some examples, the tapered surface / proximal end surface 154 extends at an acute angle measured between the inner surface 156 and the proximal end surface 154 of the first distal spacer 150.

[0069] As illustrated in FIG. 9, the inner surface 156 of the first distal spacer 150 has an increasing taper extending from the distal end surface 152 towards the proximal end surface 154 of the first distal spacer 150. In some examples, the taper of the inner surface 156 corresponds to the taper of the body portion 133 of the support sleeve 130. In some examples, the inner diameter of the innersurface 156 at the distal end of the first distal spacer 150 is less than the inner diameter of the inner surface 156 at the proximal end of the first distal spacer 150.

[0070] As provided in FIGS. 9 and 10, when assembled, the second distal spacer 160 is positioned along the support sleeve 130 proximally of the first distal spacer 150. Similar to the first distal spacer 150, the second distal spacer 160 includes an elongated annular-shaped body that extends around the support sleeve 130. In some examples, the distal end surface 162 of the second distal spacer 160 has a curved inner edge 163 extending between the distal end surface 162 and the inner surface 164 of the body portion. As described in more detail herein, in some examples, the curved inner edge 163 provides room for the projections 142 of the anchor 140 when compressed between the first distal spacer 150 and second distal spacer 160 and prevents bounce back of the projections 142 when compared to bending the projections 142 around a sharp edge.

[0071] As illustrated in FIG. 9, a portion of the distal end surface 162 of the second distal spacer 160 defines a tapered portion extending from the outer surface 166 of the second distal spacer 160 toward the curved inner edge 163. The tapered portion of the distal end surface 162 extends in a direction transverse to the longitudinal axis of the second distal spacer 160 from the curved inner edge 163 toward the distal end surface 162 of the second distal spacer 160. In some examples, the tapered portion of the distal end surface 162 extends at an obtuse angle measured between the inner surface 164 and the proximal end surface 165 if the second distal spacer 160. In some examples, the angle of the tapered proximal end surface 153 if the first distal spacer 150 has an angle corresponding to the angle of the tapered portion of the distal end surface 162 of the second distal spacer 160.

[0072] Similar to the first distal spacer 150, in some examples, the inner surface 164 of the second distal spacer 160 has an increasing taper extending from the distal end surface 162 toward the proximal end surface 165 of the second distal spacer 160. In some examples, the taper of the inner surface 164 corresponds to the taper of the body portion 133 of the support sleeve 130. In some examples, the inner diameter of the inner surface 164 at the distal end of the second distal spacer 160 is less than the inner diameter of the inner surface 164 at the proximal end of the second distal spacer 160.

[0073] As illustrated in FIGS. 8-10, the anchor 140 is provided around the support sleeve 130 between the first distal spacer 150 and second distal spacer 160. As the sheath locking nut 120 is tightened onto the sheath hub 20, the anchor 140 provides a compressive force against the portion of the expandable sheath 8 securing the expandable sheath between the sheath locking nut 120 and the support sleeve 130. In particular, the inside edge 148 of the anchor 140 provides a compressive force against the expandable sheath 8.

[0074] FIGS. 11-14 provide side, front, side, and perspective views of an example anchor 140. The anchor 140 is generally ring shaped and includes at least one projection 142 that provides the inside edge 148 for engaging an outer surface of the expandable sheath 8. As illustrated in FIGS. 10-14, the plurality of projections 142 extend radially inward from a cylindrically-shaped base member 144. The projections 142 are spaced around the circumference of the base member 144. In some examples, the projections 142 are spaced symmetrically around the base member 144. In other examples, the projections 142 are asymmetrically spaced around the base member 144. In some examples, the projections 142 have a regular or irregular shape. In some examples, the projections 142 have a curved shape. In further examples, the projections 142 have a rectilinear shape. As illustrated in FIGS. 11-14, the projections 142 have a generally triangular shape with angled side edges 146 extending from the base member 144 to an inside edge 148. In some examples, the inside edge 148 of the projections 142 includes a curved surface, having a curvature corresponding to the curvature of the base member 144. In some examples, the inside edge 148 has a generally linear shape extended between the ends of the side edges 146.

[0075] In some examples, the anchor 140 and / or projections 142 are formed from a material that will bend or otherwise deform under pressure. For example, the anchor 140 and / or projections 142 can be formed from a metal, such as stainless steel, and / or a plastic. In some examples, the anchor 140 and / or projections 142 are formed from a laser cut material and / or molded to form the projections 142.

[0076] In some examples, the projections 142 can be bent or deformed to engage the expandable sheath 8 received between the anchor 140 and the support sleeve 130, fixing the axial position of the sheath 8. For example, as illustrated in FIG. 11, the anchor 140 can be formed to have an initial generally planar shaped proximal and distal surface, where the projections 142 extend radially toward the longitudinal axis of the sheath hub assembly 100 in the same direction as the base member 144. Compressing the anchor 140 between the first distal spacer 150 and second distal spacer 160 causes the anchor 140 / projections 142 to deform into an angled shape, as illustrated in FIGS. 12-14. In particular, in some examples, contact between the anchor 140 and the tapered proximal end surface 153 of the first distal spacer 150 and / or the tapered distal end surface 162 of the second distal spacer 160 causes the anchor 140 / projections 142 to bend to a corresponding angle (and into contact with the sheath 8). In some examples, the anchor 140 / projections 142 are bent in a direction opposite the insertion direction of the sheath 8 onto the support sleeve 130. In further examples, the anchor 140 / projections 142 are bent in a direction corresponding with the insertion direction of the sheath 8 onto the support sleeve 130.

[0077] In further examples, the anchor 140 is formed such that the projections 142 have an initial bent / angled shape as illustrated in FIGS. 12-14. The anchor 140 can be positioned with respect to the first distal spacer 150 and second distal spacer 160 such that the angle of the projections 142 corresponds with the angle of the tapered proximal end surface 153 of the first distal spacer 150 and / or the tapered distal end surface 162 of the second distal spacer 160. In other examples, the anchor 140 is positioned with respect to the first distal spacer 150 and second distal spacer 160 such that the angle of the projections 142 is opposite the angle of the tapered proximal end surface 153 of the first distal spacer 150 and / or the tapered distal end surface 162 of the second distal spacer 160, and compressing the anchor 140 between the first distal spacer 150 and second distal spacer 160 causes the projections 142 to align with the tapered proximal end surface 153 and / or distal end surface 162 and compress into the sheath 8.

[0078] As described herein and illustrated in FIGS. 8-10, the sheath hub assembly 100 includes sealing members that help to secure the sheath 8 to the support sleeve 130 while also ensuring hemostasis between the sheath 8 and the sheath hub 110. The sealing members include a distal seal member 170 and a proximal seal member 190. The sealing members can include elastic o-rings including, for example, silicone o-rings.

[0079] As provided in FIGS. 8-9, when assembled, the distal seal member 170 extends around the support sleeve 130 at a position axially spaced between the second distal spacer 160 and a proximal spacer 180. In some examples, the distal seal member 170 is compressed between the second distal spacer 160 and the proximal spacer 180 such that the distal seal member 170 provides an inwardly directed force against the support sleeve 130 and / or a portion of the expandable sheath 8 extending between the support sleeve 130 and the distal seal member 170. As a result, in some examples, the distal seal member 170 ensures hemostasis / prevents blood flow between the expandable sheath 8 and the sheath hub assembly 100.

[0080] As provided in FIGS. 8-9, when assembled, the proximal seal member 190 is provided at the proximal end 137 of the support sleeve 130. In some examples, the proximal seal member 190 is provided at the proximal end 137 of the support sleeve 130 between the support sleeve 130 and the sheath hub 110. As illustrated in FIGS. 8-9, the proximal seal member 190 extends around the distal portion of the sheath hub 110. The proximal seal member 190 is compressed between the proximal end 137 of the support sleeve 130, the distal end of the sheath hub 110, and / or the inner surface of the sheath locking nut 120. As a result, in some examples, the proximal seal member 190 helps to ensure hemostasis / prevent blood flow between the expandable sheath 8 and exterior of the sheath hub 110 / sheath hub assembly 100.

[0081] As illustrated in FIGS. 8-9, a proximal spacer 180 is received over the support sleeve 130, and positions the distal seal member 170 along the body portion 133 of the support sleeve 130. The proximal spacer 180 has an elongated annular-shaped body portion with a central lumen extending therethrough. When assembled, the proximal spacer 180 is located within the central lumen 122 of the sheath locking nut 120 between the proximal end 124 of the sheath locking nut 120 and the second distal spacer 160.

[0082] As provided in FIG. 9, the proximal end surface 182 of the proximal spacer 180 abuts the shoulder 135 projecting from the outer surface of the support sleeve 130. In some examples, the proximal end surface 182 of the proximal spacer 180 defines a tapered surface extending in a direction transverse to the longitudinal axis of the proximal spacer 180 from an inner surface 183 of the proximal spacer 180 in a direction towards a proximal end of the proximal spacer 180. In some examples, the tapered surface extends at an obtuse angle measured between the inner surface 183 and the proximal end surface 182 of the proximal spacer 180.

[0083] In some examples, as illustrated in FIG. 8, the distal end surface 186 of the proximal spacer 180 includes a generally planar end surface 184 extending from the outer surface 185 of the proximal spacer 180 and a curved inner edge 187 between the planar end surface 184 and the inner surface 183 of the proximal spacer 180.

[0084] In some examples, the inner surface 183 of the proximal spacer 180 has an increasing taper extending from the distal end surface 186 towards the proximal end surface 182. In some examples, the taper of the inner surface 183 corresponds to the taper of the body portion 133 of the support sleeve 130. In some examples, the inner diameter of the inner surface 183 at the distal end of the proximal spacer 180 is less than the inner diameter of the inner surface 183 at the proximal end of the proximal spacer 180.

[0085] As described herein and as illustrated in FIGS. 8 and 9, the sheath locking nut 120 couples to the distal end of the sheath hub 20, fixing the sheath 8 therebetween. The sheath locking nut 120 and sheath hub 110 each include a central lumen 112 extending therethrough. When assembled, the central lumen 112 of the sheath hub 110 is aligned with the central lumens of the sheath locking nut 120, support sleeve 130, anchor 140, first distal spacer 150, second distal spacer 160, distal seal member 170, proximal spacer 180, proximal seal member 190, and the sheath 8.

[0086] As illustrated in FIG. 9, the sheath locking nut 120 includes a first shoulder 123 and a second shoulder 127. The first shoulder 123 is provided on an inner surface of the sheath locking nut 120 adjacent the distal end of the sheath locking nut 120. The first shoulder 123 extends from the distal opening 125 to a distal reduced diameter portion 126. The second shoulder 127 is provided on the inner surface of the sheath locking nut 120 positioned axially between the first shoulder 123 and theproximal end 124 of the sheath locking nut 120. The second shoulder 127 extends between the distal reduced diameter portion 126 and a proximal reduced diameter portion 128 of the sheath locking nut 120. As illustrated in FIG. 9, the diameter of the distal reduced diameter portion 126 is less than the diameter of the proximal reduced diameter portion 128. In some examples, as illustrated in FIG. 9, when assembled the first distal spacer 150 abuts the first shoulder 123 and the distal seal member 170 abuts the second shoulder 127.

[0087] The sheath locking nut 120 includes a coupling interface for coupling the sheath locking nut 120 with the sheath hub 110. In some examples, the coupling interface can include a threaded coupling, a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (for example, an adhesive), a weld, a thermal process, and / or any other suitable coupling process known in the art. In some examples, the sheath locking nut 120 includes a threaded surface 129 sized and configured to engage a corresponding threaded surface provided on the outer surface of the sheath hub 110. In some examples, the threaded surface 129 extends from the proximal end 124 of the sheath locking nut 120 toward the proximal reduced diameter portion 128. Similarly, the distal end of the sheath hub 110 includes a threaded surface 114 for coupling with the corresponding threaded surface 129 provided on the sheath locking nut 120.

[0088] A method of securing the delivery sheath 8 to a sheath hub 110 using a sheath hub assembly 100 is described herein. In general, and as described in more detail herein, the proximal end of the sheath 8 is positioned between the sheath hub 110 and the sheath locking nut 120 such that coupling / tightening the sheath locking nut 120 to the sheath hub 110 fixes the sheath 8 to the sheath hub 110.

[0089] The method includes providing an expandable sheath 8 as described and incorporated herein. The sheath 8 includes a central lumen 9 through which the medical device (implant 12) and / or delivery apparatus 10 travels into the patient's vessel in order to deliver, remove, repair, and / or replace a prosthetic device. As described herein, the sheath 8 can have a natural, unexpanded outer diameter that will expand locally upon passage of the medical device. The temporary, localized nature of the expansion can reduce trauma to the blood vessel into which the sheath 8 is inserted, along with the surrounding tissue, because only the portion of the sheath 8 occupied by the medical device and / or delivery apparatus 10 expands beyond the sheath's natural unexpanded diameter and the sheath 8 collapses back to the initial diameter once the medical device / delivery apparatus 10 has passed. This limits the amount and time the vessel tissue must be stretched in order to introduce the prosthetic device.

[0090] In some examples, the expandable sheath 8 can comprise a plurality of coaxial layers extending along at least a portion of the length of the sheath 8. In some examples, the coaxial layersinclude one or more folded portions extending along a length of the sheath 8. The structure of the coaxial layers is described in more detail, for example, in U.S. Patent Application No. 16 / 378,417, entitled "Expandable Sheath," U.S. Patent Application No. 17 / 716,882, entitled "Expandable Sheath," and U.S. Patent Application No. 14 / 880,109, entitled "Expandable Sheath," the disclosures of which are herein incorporated by reference.

[0091] The method includes providing a sheath hub assembly 100 as described herein. In some examples, the method further includes positioning a proximal seal member 190 on the sheath hub 110. As illustrated in FIG. 9, the proximal seal member 190 is positioned adjacent to and / or abuts the shoulder 118, distal the threaded surface 114 of the sheath hub 110.

[0092] The support sleeve 130 is then positioned adjacent / on the distal end of the sheath hub 110 such that the proximal seal member 190 is located between the proximal end 137 of the support sleeve 130 and the sheath hub 110. As described herein, when the sheath locking nut 120 is coupled to the sheath hub 110, the proximal seal member 190 is compressed between the support sleeve 130 and the shoulder 118 on the sheath hub 110.

[0093] The method further includes positioning the proximal spacer 180 on the body portion 133 of the support sleeve 130. In some examples, the proximal spacer 180 is advanced over the body portion 133 until the proximal end surface 182 of the proximal spacer 180 abuts the shoulder 135 provided on the support sleeve 130.

[0094] In some examples, the method further includes positioning the distal seal member 170 on the body portion 133 of the support sleeve 130. In some examples, the distal seal member 170 is advanced over the body portion 133 until it is positioned adjacent the distal end surface 186 of the proximal spacer 180.

[0095] The method further includes positioning the second distal spacer 160 on the body portion 133 of the support sleeve 130. The second distal spacer 160 is advanced along the body portion 133, such that the distal seal member 170 is located between the second distal spacer 160 and the proximal spacer 180.

[0096] The method further includes positioning the anchor 140 over the body portion 133 of the support sleeve 130. In some examples, the anchor 140 is advanced over the body portion 133 such that at least a portion of the anchor 140 is located proximate and or abuts the proximal end surface 165 of the second distal spacer 160.

[0097] The first distal spacer 150 is then positioned on the body portion 133 of the support sleeve 130 adjacent the anchor 140. As such, when assembled, the first distal spacer 150 is positioned adjacent the first shoulder 123 provided in the central lumen 122 of the sheath locking nut 120.Moreover, and as described in more detail herein, when assembled, the anchor 140 is positioned between the first distal spacer 240 and the second distal spacer 250.

[0098] The sheath locking nut 120 is then advanced over the body portion 133 of the support sleeve 130 and associated sheath hub assembly 100 components provided thereon. In some examples, the sheath locking nut 120 is initia lly / pa rtially coupled to the sheath hub 110. For example, the threaded surface 129 provided on the sheath locking nut 120 is partially threadably coupled to the corresponding threaded surface 114 provided on the sheath hub 110. In some examples, with the sheath locking nut 120 partially coupled to the sheath hub 110, a distal end portion of the body portion 133 of the support sleeve 130 extends through and beyond a distal opening 125 of the sheath locking nut 120.

[0099] With the sheath locking nut 120 partially coupled to the sheath hub 110, sheath 8 is advanced into the sheath hub assembly 100. In some examples, the proximal end 102 of the expandable sheath 8 is advanced over the body portion 133 of the support sleeve 130, such that the support sleeve 130 is received within the central lumen 9 of the sheath 8. In some examples, a portion of the body portion 133 extends through the distal opening 125 of the sheath locking nut 120 and provides a leading surface for supporting and / or guiding the expandable sheath 8 as it is loaded into the sheath hub assembly 100. As such, the proximal end 102 of the expandable sheath 8 is advanced over the portion of the body portion 133 extending through the distal opening 125 of the sheath locking nut 120 and into / through the distal opening 125 of the sheath locking nut 120. In some examples, the distal opening 125 of the sheath locking nut 120 has a diameter ranging from 420 mm to 485 mm. In some examples, the diameter of the distal opening 125 ranges from 440 mm to 465 mm. In some examples, the diameter of the distal opening is approximately 440 mm.

[0100] The proximal end 102 of the sheath 8 is further advanced into the central lumen 122 of the sheath locking nut 120 and over the body portion 133 of the support sleeve 130 and into the space / gap provided between the support sleeve 130 and the first distal spacer 150, second distal spacer 160, anchor 140, distal seal member 170, and the proximal spacer 180. In some examples, the sheath 8 is advanced within the sheath locking nut 120 / over the body portion 133 until the proximal end 102 of the sheath 8 of is located adjacent the shoulder 135 of the support sleeve 130. In some examples, the sheath 8 is advanced within the sheath locking nut 120 / over the support sleeve 130 until the proximal end 102 of the sheath 8 abuts the shoulder 135 of the support sleeve 130. As illustrated in FIG. 9, the sheath 8 is advanced over the support sleeve 130 such that the sheath 8 extends proximally beyond the distal seal member 170 and is positioned between the distal seal member 170 and the elongated body portion 133 of the support sleeve 130. In some examples, thesheath 8 extends along the support sleeve 130 a length ranging from 0.2" to 0.8". In some examples, the expandable sheath 8 extends along the support sleeve 0.6".

[0101] In some examples, as illustrated in FIGS. 15-16, the sheath locking nut 210 is separate from / not (partially) coupled to the sheath hub 110 before the sheath 8 is advanced over the support sleeve 130. In this example, the sheath 8 is advanced into position over the support sleeve 130 until the proximal end 102 of the sheath 8 is located adjacent the shoulder 135 of the support sleeve 130. The distal end of the sheath 8 is advanced within the central lumen 122 of the sheath locking nut 120, and the sheath locking nut 120 is advanced over the sheath 8 to the sheath hub 110. The sheath locking nut 120 is then coupled to the sheath hub 110 as described herein.

[0102] In some examples, the proximal end 102 of the expandable sheath 8 includes a flared proximal end portion. In some examples, the outer diameter of the proximal end 102 of the expandable sheath 8 is less than the inner diameter of distal opening 125 of the sheath locking nut 120 and / or the distal opening of the first distal spacer 150. In some examples, when loading the expandable sheath 8 onto the support sleeve 130, the flared proximal end portion is advanced into the spacing / gap between the sheath locking nut 120 and the support sleeve 130.

[0103] With the sheath 8 in position with respect to the support sleeve 130 and / or sheath locking nut 120, the engagement feature of the sheath locking nut 120 is coupled with the corresponding engagement feature of the sheath hub 110. For example, the threaded surface 129 on the sheath locking nut 120 is coupled with the threaded surface 114 on the sheath hub 110.

[0104] In some examples, further engaging the engagement feature / threaded surface 129 of the sheath locking nut 120 with the corresponding engagement feature / threaded surface 114 of the sheath hub 110 causes the anchor 140 to provide a compressive force against the outer surface of the expandable sheath 8. As a result, the sheath 8 is secured between the sheath locking nut 120 and the support sleeve 130, fixing the axial and / or rotational position of the expandable sheath 8 with respect to at least one of the sheath locking nut 120 or the support sleeve 130. In some examples, as the sheath locking nut 120 is tightened onto the sheath hub 110, the anchor 140 is drawn into engagement with the outer surface of the expandable sheath 8. For example, tightening the sheath locking nut 120 onto the sheath hub 110 compresses the anchor 140 between the first distal spacer 150 and the second distal spacer 160 such that the anchor 140 and / or projections 142 deform to have an angle (or shape) corresponding to at least one of the proximal end surface 154 of the first distal spacer 150 or the distal end surface 162 of the second distal spacer 160. In some examples, bending the anchor 140 and / or projections 142 causes the projections 142 to extend radially into the central lumen 122 of the sheath locking nut 120 toward the support sleeve 130 and engage the expandable sheath 8 received between the anchor 140 and the support sleeve 130. Thisfixes the axial position of the expandable sheath 8 with respect to the anchor 140, support sleeve 130, and / or the sheath locking nut 120.

[0105] In some examples, the further engagement between the sheath locking nut 120 and the sheath hub 110, compresses the distal seal member 170 between the distal end surface 186 of the proximal spacer 180 and the proximal end surface 165 of the second distal spacer 160 thereby providing an inwardly directed force against the support sleeve 130 and / or a portion of the expandable sheath 8 extending between the support sleeve 130 and the distal seal member 170. In some examples, compression of the distal seal member 170 against the sheath 8 prevents blood flow between the expandable sheath 8 and the outer surface of sheath hub 110, ensuring hemostasis / prevent blood flow between the expandable sheath 8 and the sheath hub assembly 100.

[0106] In some examples, the further engagement between the sheath locking nut 120 and the sheath hub 110, compresses the proximal seal member 190 between the proximal end 137 of the support sleeve 130 and the distal end of the sheath hub 110. This helps to seal the connection between the expandable sheath 8 and the outer surface of the sheath hub 110. In some examples, this also helps to seal the connection between the sheath hub 110 and the support sleeve 130.

[0107] In some examples, the further engagement between the sheath locking nut 120 and the sheath hub 110 causes the distal end surface 152 of the first distal spacer 150 to engage with the first shoulder 123 provided on an inner surface of the sheath locking nut 120 adjacent a distal end of the sheath locking nut 120.

[0108] With the axial and rotational position of the sheath 8 fixed with respect to the sheath hub 110 fixed, the sheath 8 can be used to deliver a medical device to a treatment site within a patient. As described herein, the sheath 8 can be used to introduce the medical device (implant 12) and / or delivery apparatus 10 into a patient's body. The sheath 8 can be coupled to the sheath hub 110 using the sheath hub assembly 100 as described herein. The sheath includes any of the example radially expandable sheath 8 configurations described and incorporated herein. As described herein, the sheath 8 is movable between an unexpanded configuration at a first diameter and an expanded configuration at a second, larger, diameter.

[0109] The sheath 8 is inserted at least partially into the patient's blood vessel. In some examples, an introducer 6 is provided within the central lumen 9 of the sheath 8 as it is advanced into the patient's blood. The introducer 6 provides axial and radial support to the sheath 8 as it is advanced within the patient. The introducer 6 is then withdrawn from the sheath 8, leaving the central lumen 9 open / available for the medical device / delivery apparatus 10 to be positioned within the sheath 8. In some examples, a guide wire can be at least partially inserted into the patient's blood vessel andthe sheath 8 / introducer 6 can be advanced over the guide wire through the blood vessel to the treatment site.

[0110] With the central lumen 9 of the sheath 8 free of the introducer 6, the medical device is then introduced into the central lumen 9 at the proximal end of the sheath 8. The medical device is then advanced through the central lumen 9 of the sheath 8. In some examples, the movement of the medical device within the central lumen 9 of the sheath 8 causes the sheath 8 to radially expand as the medical device exerts an outwardly directed radial force against the central lumen 9 of the sheath 8, causing the sheath 8 to locally expand from the unexpanded configuration at the first diameter, to / toward the expanded configuration at the second, larger, diameter. As the medical device passes through the sheath 8, the portion of the sheath 8 locally contracts at least partially back to / toward the unexpanded configuration.

[0111] The medical device, for example implant 12, is advanced through the sheath 8 and beyond a distal opening in the sheath 8 to the treatment site within the blood vessel and / or heart tissue of the patient. The medical device is deployed beyond distal opening of the sheath 8 and delivered to the patient. Once the medical device is delivered to the patient, the delivery apparatus 10 is removed / withdrawn from the sheath 8.

[0112] In some examples, advancing the medical device (implant 12) through the central lumen 9 of the sheath 8 can include advancing the delivery apparatus 10 and the medical device through the central lumen 9 of the sheath 8 and into the vasculature of a patient. Accessing the treatment site may require creating an opening in the heart tissue (for example, foramen ovalis) of the patient. In some examples, after the introducer 6 is removed from the sheath 8, a cutting instrument can be advanced through the sheath 8 to create an opening in the patient's heart tissue. In some examples, the sheath 8 is inserted into a femoral artery of the patient.

[0113] In the example systems described herein, the medical device / implant 12 may be a prosthetic device mounted in a radially crimped state on a delivery apparatus 10, and advancing the prosthetic device through the central lumen 9 of the sheath 8 includes advancing the delivery apparatus 10 and the prosthetic device through central lumen 9 of the sheath 8 and into a vasculature of the patient. In some examples, the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient. In some examples, the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus 10 as the prosthetic heart valve is advanced through the sheath 8.

[0114] Exemplary Aspects

[0115] In view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosures. These particularly recited aspects should not,however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the "particular" aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.

[0116] Example 1. A system for connecting an expandable sheath to a sheath hub including: an expandable sheath; a sheath locking nut for securing the expandable sheath to a sheath hub, the sheath locking nut including a central lumen extending therethrough; a support sleeve received within the sheath locking nut, the support sleeve for providing a support surface for the expandable sheath and including a central lumen coaxial with the central lumen of the sheath locking nut; and an anchor provided within the central lumen of the sheath locking nut for providing a compressive force against the expandable sheath when received within the central lumen of the sheath locking nut, the anchor securing the expandable sheath between the sheath locking nut and the support sleeve.

[0117] Example 2. The system according to any example herein, particularly example 1, further including: a first distal spacer received within the central lumen of the sheath locking nut adjacent a distal end of the sheath locking nut; and a second distal spacer received within the central lumen of the sheath locking nut, where the first distal spacer is positioned between the second distal spacer and the distal end of the sheath locking nut, wherein the anchor is positioned between the first distal spacer and the second distal spacer.

[0118] Example 3. The system according to any example herein, particularly example 2, wherein first distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the first distal spacer abuts a first shoulder provided on the central lumen of the sheath locking nut, and a proximal end surface of the first distal spacer defines a tapered surface.

[0119] Example 4. The system according to any example herein, particularly example 3, wherein the tapered surface of the proximal end surface of the first distal spacer extends in a direction transverse to a longitudinal axis of the first distal spacer from an inner surface of the first distal spacer in a direction toward a distal end of the first distal spacer.

[0120] Example 5. The system according to any example herein, particularly examples 3-4, wherein an inner surface of the body portion of the first distal spacer has an increasing taper extending from the distal end surface towards the proximal end surface of the first distal spacer.

[0121] Example 6. The system according to any example herein, particularly examples 2-5, wherein the second distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the second distal spacer has a curved inner edge extending between the distal end surface and an inner surface of the body portion.

[0122] Example 7. The system according to any example herein, particularly example 6, wherein the distal end surface of the second distal spacer defines a tapered surface extending from an outer surface of the second distal spacer toward the curved inner edge, the tapered surface extending in a direction transverse to a longitudinal axis of the second distal spacer from the curved inner edge toward a distal end of the second distal spacer.

[0123] Example 8. The system according to any example herein, particularly examples 6-7, wherein the inner surface of the body portion of the second distal spacer has an increasing taper extending from the distal end surface toward the proximal end surface of the second distal spacer.

[0124] Example 9. The system according to any example herein, particularly examples 2-8, wherein the anchor is positioned between the first distal spacer and the second distal spacer.

[0125] Example 10. The system according to any example herein, particularly example 9, wherein the anchor has a generally planar shape and compressing the anchor between the first distal spacer and second distal spacer causes at least a portion of the anchor to deform into an angled shape and extend radially into the central lumen of the sheath locking nut toward the support sleeve (for example, contact between the anchor and the tapered proximal end surface of the first distal spacer and / or the tapered distal end surface of the second distal spacer causes the anchor to bend to a corresponding angle).

[0126] Example 11. The system according to any example herein, particularly examples 1-10, wherein the anchor has a ring shape and includes at least one projection for engaging an outer surface of the expandable sheath.

[0127] Example 12. The system according to any example herein, particularly examples 2-11, further including: a proximal spacer received within the central lumen of the sheath locking nut and including an elongated annular-shaped body portion that extends around the support sleeve, wherein the proximal spacer is provided within the central lumen of the sheath locking nut between a proximal end of the sheath locking nut and the second distal spacer.

[0128] Example 13. The system according to any example herein, particularly example 12, wherein a proximal end surface of the proximal spacer abuts a second shoulder projecting from an outer surface of the support sleeve, wherein the proximal end surface of the proximal spacer defines a tapered surface extending in a direction transverse to a longitudinal axis of the proximal spacer from an inner surface of the proximal spacer in a direction towards a proximal end of the proximal spacer.

[0129] Example 14. The system according to any example herein, particularly examples 12-13, wherein a distal end surface of the proximal spacer includes a generally planar end surface extending from an outer surface of the proximal spacer and a curved inner edge between the planar end surface and an inner surface of the proximal spacer.

[0130] Example 15. The system according to any example herein, particularly examples 12-14, where an inner surface of the proximal spacer has an increasing taper extending from the distal end surface towards the proximal end surface of the proximal spacer.

[0131] Example 16. The system according to any example herein, particularly examples 1-15, wherein the support sleeve includes an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending between the body portion and a larger diameter collar provided adjacent a proximal end of the support sleeve, wherein, when assembled, the distal end of the support sleeve extends beyond the distal end of the sheath locking nut.

[0132] Example 17. The system according to any example herein, particularly example 16, wherein the shoulder extends from the body portion in a direction transverse to a longitudinal axis of the support sleeve from the body portion toward the proximal end of the support sleeve.

[0133] Example 18. The system according to any example herein, particularly examples 16-17, wherein the inner surface of the body portion of the support sleeve has an increasing taper extending from the distal end toward the proximal end of the support sleeve.

[0134] Example 19. The system according to any example herein, particularly examples 12-18, further including: a distal seal member extending around the support sleeve axially spaced between the second distal spacer and the proximal spacer, and a proximal seal member provided at a proximal end of the support sleeve.

[0135] Example 20. The system according to any example herein, particularly examples 1-19, where the sheath locking nut includes: a first shoulder provided on an inner surface of the sheath locking nut adjacent a distal end of the sheath locking nut, the first shoulder extends from a distal opening to a distal reduced diameter portion, and a second shoulder provided on the inner surface of the sheath locking nut positioned axially between the first shoulder and the proximal end of the sheath locking nut, the second shoulder extends between the distal reduced diameter portion and a proximal reduced diameter portion, wherein the diameter of the distal reduced diameter portion is less than the diameter of the proximal reduced diameter portion (for example, when assembled the first distal spacer abuts the first shoulder and the distal seal member abuts the second shoulder).

[0136] Example 21. The system according to any example herein, particularly example 20, wherein the sheath locking nut further includes a threaded surface extending from the proximal end of the sheath locking nut toward the proximal reduced diameter portion.

[0137] Example 22. A connector system for connecting an expandable sheath to a sheath hub including: a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature (for example, threaded inner surface) for coupling with acorresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut, at least a portion of the anchor extending toward a longitudinal axis of the sheath locking nut.

[0138] Example 23. The system according to any example herein, particularly example 22, further including: a first distal spacer received within the central lumen of the sheath locking nut adjacent a distal end of the sheath locking nut; a second distal spacer received within the central lumen of the sheath locking nut proximal of the first distal spacer, where the anchor is positioned between the first distal spacer and the second distal spacer; a proximal spacer received within the central lumen of the sheath locking nut proximal of the second distal spacer; a distal seal member received within the central lumen the sheath locking nut between the second distal spacer and the proximal spacer; and a proximal seal member received within the central lumen the sheath locking nut between a proximal end of the support sleeve and the sheath hub, wherein engagement compression of the anchor between the first distal spacer and the second distal spacer causes the anchor to bend to an angle (and / or shape) corresponding to at least one of the proximal end surface of the first distal spacer or the distal end surface of the second distal spacer and extend radially toward the longitudinal axis of the sheath locking nut (for example, toward the support sleeve).

[0139] Example 24. A method of securing a delivery sheath to a sheath hub using a connector system, the method including: (1) providing an expandable sheath; (2) providing a sheath hub assembly including: a sheath hub; a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature (for example, threaded inner surface) for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut; (3) positioning the support sleeve adjacent the distal end of the sheath hub such that the anchor is located between the sheath locking nut and the support sleeve; (4) advancing the support sleeve with the central lumen of the sheath locking nut such that a portion of the body portion extends through and beyond a distal opening of the sheath locking nut; (5) advancing a proximal end of the expandable sheath over the portion of the bodyportion extending through the distal opening of the sheath locking nut; (6) advancing the proximal end of the expandable sheath into the central lumen of the sheath locking nut and over the body portion; (7) coupling the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub; and (8) further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub causing the anchor to provide a compressive force against an outer surface of the expandable sheath, thereby securing the expandable sheath between the sheath locking nut and the support sleeve and fixing an axial position of the expandable sheath with respect to at least one of the sheath locking nut or the support sleeve (for example, as the sheath locking nut is tightened on to the sheath hub, the anchor is drawn into engagement with the outer surface of the expandable sheath).

[0140] Example 25. The method according to any example herein, particularly example 24, wherein the connector system further includes: (1) positioning a proximal seal member on the sheath hub such that when the sheath locking nut is coupled to the sheath hub, the proximal seal member is located between the proximal end of the support sleeve and the sheath hub; (2) positioning a proximal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the proximal end surface of the proximal spacer abuts the shoulder provided on the support sleeve; (3) positioning a distal seal member on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the distal seal member is positioned adjacent the distal end surface of the proximal spacer; (4) positioning a second distal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the distal seal member is positioned between the second distal spacer and the proximal spacer, and the proximal spacer is proximal of the second distal spacer; and (5) positioning a first distal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the first distal spacer is positioned adjacent a distal end of the sheath locking nut and the and the anchor is positioned between the first distal spacer and the second distal spacer.

[0141] Example 26. The method according to any example herein, particularly example 25, wherein further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub: (1) compresses the proximal seal member between the proximal end of the support sleeve and a distal end of the sheath hub; (2) engages a proximal end surface of the proximal spacer with the shoulder projecting radially outward from the support sleeve; (3) compresses the distal seal member between the distal end surface of the proximal spacer and the proximal end surface of the second distal spacer thereby providing an inwardly directed force against the support sleeve and / or a portion of the expandable sheath extending between thesupport sleeve and the distal seal member; (4) bends the anchor between the first distal spacer and the second distal spacer such that the anchor deforms to have an angle (or shape) corresponding to at least one of the proximal end surface of the first distal spacer or the distal end surface of the second distal spacer, where bending the anchor causes the anchor to extend radially into the central lumen of the sheath locking nut toward the support sleeve and engage the expandable sheath received between the anchor and the support sleeve fixing the axial position of the expandable sheath with respect to the support sleeve and / or the sheath locking nut; and (5) engages the distal end surface of the first distal spacer with the first shoulder provided on an inner surface of the sheath locking nut adjacent a distal end of the sheath locking nut.

[0142] Example 27. The method according to any example herein, particularly examples 24-26, wherein advancing the proximal end of the expandable sheath into the central lumen of the sheath locking nut includes advancing the expandable sheath until the proximal end of the expandable sheath of is located adjacent the shoulder of the support sleeve (for example, the expandable sheath is advanced within the sheath locking nut until the proximal end abuts the shoulder of the support sleeve).

[0143] Example 28. The method according to any example herein, particularly examples 24-27, wherein the proximal end of the expandable sheath 8 includes a flared proximal end portion.

[0144] Example 29. A method of delivering a medical device, the method comprising: (1) providing an expandable sheath; (2) providing a sheath hub assembly including: a sheath hub; a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature (for example, threaded inner surface) for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut; (3) positioning the support sleeve adjacent the distal end of the sheath hub such that the anchor is located between the sheath locking nut and the support sleeve; (4) advancing the support sleeve with the central lumen of the sheath locking nut such that a portion of the body portion extends through and beyond a distal opening of the sheath locking nut; (5) advancing a proximal end of the expandable sheath over the portion of the body portion extending through the distal opening of the sheath locking nut; (6) advancing the proximal end of the expandable sheath into the central lumen of the sheath locking nut and over the body portion; (7) coupling the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub; (8) furtherengaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub causing the anchor to provide a compressive force against an outer surface of the expandable sheath, thereby securing the expandable sheath between the sheath locking nut and the support sleeve and fixing an axial position of the expandable sheath with respect to at least one of the sheath locking nut or the support sleeve; (9) inserting the expandable sheath at least partially into the blood vessel of the patient; (10) advancing the distal end of the sheath to the treatment site; (11) advancing a medical device through the central lumen of the sheath to the treatment site; (12) locally expanding the sheath from an initial condition / diameter to a locally expanded condition / diameter by the outwardly directed radial force of the medical device; (13) locally contracting the sheath from the locally expanded condition at least partially back to the initial condition using inwardly directed radial force an elastic feature of the sheath; and (14) delivering the medical device to the treatment site.

[0145] Example 30. The method according to any example herein, particularly example 29, wherein the medical device is a prosthetic device mounted in a radially crimped state on a delivery apparatus.

[0146] Example 31. The method according to any example herein, particularly example 30, wherein the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.

[0147] Example 32. The method according to any example herein, particularly example 31, wherein the prosthetic heart valve is mounted on a balloon catheter of a delivery apparatus as the prosthetic heart valve is advanced through the sheath.

[0148] In view of the many possible aspects to which the principles of the disclosed disclosure can be applied, it should be recognized that the illustrated aspects are only preferred examples of the disclosure and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims. We, therefore, claim as our disclosure all that comes within the scope and spirit of these claims.

Claims

What is claimed:

1. A system for connecting an expandable sheath to a sheath hub including: an expandable sheath; a sheath locking nut for securing the expandable sheath to a sheath hub, the sheath locking nut including a central lumen extending therethrough; a support sleeve received within the sheath locking nut, the support sleeve for providing a support surface for the expandable sheath and including a central lumen coaxial with the central lumen of the sheath locking nut; and an anchor provided within the central lumen of the sheath locking nut for providing a compressive force against the expandable sheath when received within the central lumen of the sheath locking nut, the anchor securing the expandable sheath between the sheath locking nut and the support sleeve.

2. The system of any of claim 1, further including: a first distal spacer received within the central lumen of the sheath locking nut adjacent a distal end of the sheath locking nut; and a second distal spacer received within the central lumen of the sheath locking nut, where the first distal spacer is positioned between the second distal spacer and the distal end of the sheath locking nut, wherein the anchor is positioned between the first distal spacer and the second distal spacer.

3. The system of claim 2, wherein first distal spacer includes an elongated annularshaped body portion that extends around the support sleeve, a distal end surface of the first distal spacer abuts a first shoulder provided on the central lumen of the sheath locking nut, and a proximal end surface of the first distal spacer defines a tapered surface.

4. The system of claim 3, wherein the tapered surface of the proximal end surface of the first distal spacer extends in a direction transverse to a longitudinal axis of the first distal spacer from an inner surface of the first distal spacer in a direction toward a distal end of the first distal spacer.

5. The system of claim 3, wherein an inner surface of the body portion of the first distal spacer has an increasing taper extending from the distal end surface towards the proximal end surface of the first distal spacer.

6. The system of claim 2, wherein the second distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the second distal spacer has a curved inner edge extending between the distal end surface and an inner surface of the body portion.

7. The system of claim 6, wherein the distal end surface of the second distal spacer defines a tapered surface extending from an outer surface of the second distal spacer toward the curved inner edge, the tapered surface extending in a direction transverse to a longitudinal axis of the second distal spacer from the curved inner edge toward a distal end of the second distal spacer.

8. The system of claim 6, wherein the inner surface of the body portion of the second distal spacer has an increasing taper extending from the distal end surface toward a proximal end surface of the second distal spacer.

9. The system of claim 2, wherein the anchor is positioned between the first distal spacer and the second distal spacer, and wherein the anchor has a generally planar shape and compressing the anchor between the first distal spacer and second distal spacer causes at least a portion of the anchor to deform into an angled shape and extend radially into the central lumen of the sheath locking nut toward the support sleeve.

10. The system of claim 2, further including: a proximal spacer received within the central lumen of the sheath locking nut and including an elongated annular-shaped body portion that extends around the support sleeve, wherein the proximal spacer is provided within the central lumen of the sheath locking nut between a proximal end of the sheath locking nut and the second distal spacer.

11. The system of claim 10, wherein a proximal end surface of the proximal spacer abuts a second shoulder projecting from an outer surface of the support sleeve,wherein the proximal end surface of the proximal spacer defines a tapered surface extending in a direction transverse to a longitudinal axis of the proximal spacer from an inner surface of the proximal spacer in a direction towards a proximal end of the proximal spacer.

12. The system of claim 10, wherein a distal end surface of the proximal spacer includes a generally planar end surface extending from an outer surface of the proximal spacer and a curved inner edge between the planar end surface and an inner surface of the proximal spacer.

13. The system of claim 1, wherein the support sleeve includes an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending between the body portion and a larger diameter collar provided adjacent a proximal end of the support sleeve, wherein, when assembled, the distal end of the support sleeve extends beyond the distal end of the sheath locking nut.

14. The system of any one of claim 10, further including: a distal seal member extending around the support sleeve axially spaced between the second distal spacer and the proximal spacer, and a proximal seal member provided at a proximal end of the support sleeve.

15. The system of claim 12, where the sheath locking nut includes: a first shoulder provided on an inner surface of the sheath locking nut adjacent a distal end of the sheath locking nut, the first shoulder extends from a distal opening to a distal reduced diameter portion, and a second shoulder provided on the inner surface of the sheath locking nut positioned axially between the first shoulder and the proximal end of the sheath locking nut, the second shoulder extends between the distal reduced diameter portion and a proximal reduced diameter portion, wherein a diameter of the distal reduced diameter portion is less than a diameter of the proximal reduced diameter portion.

16. A connector system for connecting an expandable sheath to a sheath hub including: a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature for coupling with a corresponding engagement feature provided on a sheath hub;a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of the support sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut, at least a portion of the anchor extending toward a longitudinal axis of the sheath locking nut.

17. The system of claim 16, further including: a first distal spacer received within the central lumen of the sheath locking nut adjacent a distal end of the sheath locking nut; a second distal spacer received within the central lumen of the sheath locking nut proximal of the first distal spacer, where the anchor is positioned between the first distal spacer and the second distal spacer; a proximal spacer received within the central lumen of the sheath locking nut proximal of the second distal spacer; a distal seal member received within the central lumen the sheath locking nut between the second distal spacer and the proximal spacer; and a proximal seal member received within the central lumen the sheath locking nut between a proximal end of the support sleeve and the sheath hub, wherein engagement compression of the anchor between the first distal spacer and the second distal spacer causes the anchor to bend to an angle and / or shape corresponding to at least one of a proximal end surface of the first distal spacer or a distal end surface of the second distal spacer and extend radially toward the longitudinal axis of the sheath locking nut.

18. A method of securing a delivery sheath to a sheath hub using a connector system, the method including: providing an expandable sheath; providing a sheath hub assembly including: a sheath hub; a sheath locking nut including a central lumen extending therethrough, the sheath locking nut including an engagement feature for coupling with a corresponding engagement feature provided on a sheath hub; a support sleeve received within the central lumen of the sheath locking nut, the support sleeve including an elongated body portion extending from a distal end of thesupport sleeve to a shoulder projecting radially outward from the body portion, the shoulder extending from the body portion to a larger diameter collar provided adjacent a proximal end of the support sleeve; and an anchor provided within the central lumen of the sheath locking nut; positioning the support sleeve adjacent the distal end of the sheath hub such that the anchor is located between the sheath locking nut and the support sleeve; advancing the support sleeve with the central lumen of the sheath locking nut such that a portion of the body portion extends through and beyond a distal opening of the sheath locking nut; advancing a proximal end of the expandable sheath over the portion of the body portion extending through the distal opening of the sheath locking nut; advancing the proximal end of the expandable sheath into the central lumen of the sheath locking nut and over the body portion; coupling the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub; and further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub causing the anchor to provide a compressive force against an outer surface of the expandable sheath, thereby securing the expandable sheath between the sheath locking nut and the support sleeve and fixing an axial position of the expandable sheath with respect to at least one of the sheath locking nut or the support sleeve.

19. The method of claim 18, wherein the connector system further includes: positioning a proximal seal member on the sheath hub such that when the sheath locking nut is coupled to the sheath hub, the proximal seal member is located between the proximal end of the support sleeve and the sheath hub; positioning a proximal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the proximal end surface of the proximal spacer abuts the shoulder provided on the support sleeve; positioning a distal seal member on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the distal seal member is positioned adjacent the distal end surface of the proximal spacer; positioning a second distal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the distal seal member is positioned between the second distal spacer and the proximal spacer, and the proximal spacer is proximal of the second distal spacer; andpositioning a first distal spacer on the body portion of the support sleeve such that when the sheath locking nut is coupled to the sheath hub, the first distal spacer is positioned adjacent a distal end of the sheath locking nut and the and the anchor is positioned between the first distal spacer and the second distal spacer.

20. The method of claim 19, wherein further engaging the engagement feature of the sheath locking nut with the corresponding engagement feature of the sheath hub: compresses the proximal seal member between the proximal end of the support sleeve and a distal end of the sheath hub; engages a proximal end surface of the proximal spacer with the shoulder projecting radially outward from the support sleeve; compresses the distal seal member between the distal end surface of the proximal spacer and the proximal end surface of the second distal spacer thereby providing an inwardly directed force against the support sleeve and / or a portion of the expandable sheath extending between the support sleeve and the distal seal member; bends the anchor between the first distal spacer and the second distal spacer such that the anchor deforms to have an angle and / or shape corresponding to at least one of the proximal end surface of the first distal spacer or the distal end surface of the second distal spacer, where bending the anchor causes the anchor to extend radially into the central lumen of the sheath locking nut toward the support sleeve and engage the expandable sheath received between the anchor and the support sleeve fixing the axial position of the expandable sheath with respect to the support sleeve and / or the sheath locking nut; and engages the distal end surface of the first distal spacer with the first shoulder provided on an inner surface of the sheath locking nut adjacent a distal end of the sheath locking nut.

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