Delivery sheath stabilization devices and systems

Abstract

The disclosed sheath stabilization systems (1000), devices, and methods prevent excessive movement of the sheath (8) that is left outside a patient during a transvascular procedure. The systems (1000), devices, and methods can include a stabilizer housing (480) with a locked and unlocked position. A sheath hub (340), hub cap (320), and / or a sheath (8) can be positioned within the central space of a stabilizer housing (480). Moving the stabilizer housing (480) from the unlocked to the locked position couples the sheath hub (340), the hub cap (320), and / or the sheath (8) to the stabilizer housing (480). The position of the stabilizer housing (480) is fixed, by coupling the stabilizer housing (480) to a bed or a platform (520) upon where patients rests. Fixing the position of the stabilizer housing (480), limits movement of the coupled sheath (8), which facilitate the use of alternative vascular access approaches.

Description

DELIVERY SHEATH STABILIZATION DEVICES AND SYSTEMSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 655,282, filed June 3, 2024, which is incorporated by reference in its entirety for all purposes.FIELD

[0002] The present application is directed to a sheath for use with catheter-based technologies for repairing and / or replacing heart valves, as well as for delivering a device, such as a prosthetic valve, to a heart via the patient’ s vasculature.BACKGROUND

[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 target site. There are many types of diseases 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 removedfrom 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 be delivered 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 / access sheath can be used to safely introduce a delivery apparatus into a patient's vasculature via a vascular incision site. 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. Expandable introducer sheaths, formed of highly elastomeric materials, allow for the dilating of the vessel to be performed by the passing prosthetic device. 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.

[0007] The femoral artery is often chosen as the vascular incision site. The femoral approach involves creating an incision site in the femoral artery at the groin, then inserting the introducer sheath, then routing the delivery apparatus though the introducer sheath and to the target site. This method offers a straightforward path to major vessels, facilitating diagnostic imaging and interventions. The femoral approach is often preferred over alternative approaches for several reasons, including the large diameter of the artery, the less tortuous path to the heart and major vessels, and the relative ease and safety of access. As such, introducer sheaths are often designed to be used with a femoral approach. However, alternative vascular incision sites, which are closer to the heart, may be used according to physician preference and / or when complications preclude the femoral approach. For example, navigating a catheter over the greater distance from the femoral incision site to the heart can be difficult with vascular complications like atherosclerosis, increased tortuosity, and reduced vascular elasticity. Unfortunately, conventional introducer sheaths that are designed for the femoral approach are not well suited for use in these alternative vascular incision sites, and more innovation is needed in this area.SUMMARY

[0008] The devices, systems, and methods for stabilizing a sheath disclosed herein include a sheath stabilizer system that prevents excessive movement of the sheath, and particularly prevents excessive movement of a portion of the sheath that is left outside the patient’s bodyduring the procedure. The sheath stabilizer system is coupled to a bed or platform upon which the patient is resting improving the availability of space for other equipment and people in the procedure room, ensuring the sheath and / or delivery system are securely positioned with respect to the patient to also help reduce possible injury due to undesired sheath / delivery system movement, prevent surgeon strain, and positioning portions of the sheath and / or delivery system above the sterile barrier (e.g., sterile surgical drape) helping to ensure sterility.

[0009] In some implementations, the techniques described herein relate to a stabilizer system for use in a medical procedure to stabilize an access sheath or delivery device, the stabilizer system including: a stabilizer housing configured to interface with an access sheath and / or a delivery device, the stabilizer housing having a locked position and an unlocked position, the stabilizer housing extending between a stabilizer proximal end and a stabilizer distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or delivery device; wherein, in the locked position, the stabilizer housing couples directly to and extends at least partially around a portion of an access sheath and / or a delivery device fixing the position of the portion with respect to the stabilizer housing.

[0010] In some implementations, the techniques described herein relate to a method of stabilizing an access sheath or delivery device, the method including: handling a stabilizer housing configured to interface with an access sheath and / or medical device, the stabilizer housing having an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or a delivery device; handling a sheath hub for an access sheath and / or a delivery device including a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; positioning one or more of the sheath hub, a hub cap coupled to the sheath hub, and the sheath within the central space of the stabilizer housing at a location having a size and shape corresponding to the outer surface sheath hub, hub cap and / or sheath; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; and fixing a position of the stabilizer housing with respect to the sheath hub, hub cap, and / or sheath.

[0011] In some implementations, the techniques described herein relate to a method of delivering a medical device through a sheath, the method including: handling a stabilizer housing including an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space; handling a sheath hub including a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; coupling a hub cap to the hub distal end, the hub cap including a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough; disposing a proximal end of a sheath between the hub cap distal end and the hub distal end such that coupling the hub cap to the sheath hub fixes the sheath to the sheath hub; positioning the sheath hub, the hub cap, and the sheath within the central space of the stabilizer housing; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; inserting the sheath into an incision site of a patient; and fixing a position of the stabilizer housing, thereby fixing a location of a proximal end of the sheath.DESCRIPTION OF DRAWINGS

[0012] The device is explained in even greater detail in the following drawings. The drawings are merely exemplary and certain features may be used singularly or in combination with other features. The drawings are not necessarily drawn to scale.

[0013] FIG. 1 is an elevation view of an expandable sheath along with an endovascular delivery apparatus for implanting a prosthetic implant.

[0014] FIG. 2 is an elevation view of an expandable sheath including an introducer hub, a sheath locking sleeve, and an introducer.

[0015] FIG. 3 is an elevation view of the expandable sheath of FIG. 2 along with an endovascular delivery apparatus for implanting a prosthetic implant.

[0016] FIG. 4 is an elevation view of an expandable sheath a sheath hub, an introducer hub, and a sheath locking sleeve of FIG. 2.

[0017] FIG. 5 A is a cross sectional view of the sheath hub, introducer hub, and sheath locking sleeve of FIG. 2.

[0018] FIG 5B is a cross sectional view of the introducer cap, the sheath hub, the introducer hub, the sheath locking sleeve of FIG. 2.

[0019] FIG. 6 is a cross sectional view of the introducer cap, sheath hub, introducer hub, and sheath locking sleeve of FIG. 2.

[0020] FIG. 7 is a distal end view of the sheath locking sleeve of FIG. 2 and the proximal fluid seal of FIGS 5A-B.

[0021] FIG. 8A is a first elevation view of the introducer hub of FIG. 2 coupled to an introducer.

[0022] FIG. 8B is a second (rotated) elevation view of the introducer hub of FIG. 2 coupled to the introducer.

[0023] FIG. 8C is a distal end view of the introducer hub of FIG. 2 coupled to the introducer.

[0024] FIG. 8D is a partial side view of the introducer hub of FIG. 2 coupled to the introducer.

[0025] FIG. 8E is a partial perspective view of the introducer hub of FIG. 2 coupled to the introducer.

[0026] FIG. 8F is a partial perspective view of the introducer hub of FIG. 2 coupled to the introducer.

[0027] FIG. 9A is a distal end view of the introducer hub of FIG. 2.

[0028] FIG. 9B is a first elevation view of the introducer hub of FIG. 2.

[0029] FIG. 9C is a proximal end view of the introducer hub of FIG. 2.

[0030] FIG. 9D is a first perspective view of the introducer hub of FIG. 2.

[0031] FIG. 9E is a second elevation view of the introducer hub of FIG. 2.

[0032] FIG. 9F is a second perspective view of the introducer hub of FIG. 2.

[0033] FIG. 10A is a distal end view of the sheath locking sleeve of FIG. 2.

[0034] FIG. 10B is a first elevation view of the sheath locking sleeve of FIG. 2.

[0035] FIG. 10C is a proximal end view of the sheath locking sleeve of FIG. 2.

[0036] FIG. 10D is a first perspective view of the sheath locking sleeve of FIG. 2.

[0037] FIG. 10E is a second elevation view of the sheath locking sleeve of FIG. 2.

[0038] FIG. 10F is a second perspective view of the sheath locking sleeve of FIG. 2.

[0039] FIG. 11 is a side elevation cross-sectional view of a portion of the expandable sheath of FIGS. 1 and 2.

[0040] FIG. 12 is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2.

[0041] FIG. 13A is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2 with the outer layer removed for purposes of illustration.

[0042] FIG. 13B is a magnified view of a portion of the braided layer of the sheath of FIGS. 1 and 2.

[0043] FIG. 14 is a magnified view of a portion of the expandable sheath of FIGS. 1 and 2 illustrating expansion of the sheath as a prosthetic device is advanced through the sheath.

[0044] FIG. 15 is a side view of the expandable sheath of FIGS. 1 and 2.

[0045] FIG. 16 is a magnified section view of the sheath of FIG. 15 along section line 16-16.

[0046] FIG. 17 is cross sectional view of the unexpanded sheath of FIG. 16 along section line 17-17.

[0047] FIG. 18 is cross sectional view of the unexpanded sheath of FIG. 15 along section line 18-18.

[0048] FIG. 19 is cross sectional view of the unexpanded sheath of FIG. 15 along section line 19-19.

[0049] FIG. 20 is cross sectional view of the expanded sheath of FIG. 15 along section line 19-19.

[0050] FIG. 21 is a side view of the expandable sheath of FIGS. 1 and 2.

[0051] FIG. 22 is a cross section view of the unexpanded sheath of FIG. 21 along section line 22-22.

[0052] FIG. 23 is a cross section view of the expanded sheath of FIG. 21 along section line 22-22.

[0053] FIG. 24 shows various percutaneous vascular access approaches.

[0054] FIG. 25 shows an example system for stabilizing a sheath, wherein various components of the system are decoupled.

[0055] FIG. 26 shows the example system for stabilizing a sheath with various components of the system coupled and ready for a procedure.

[0056] FIG. 27 shows an example sheath stabilizer housing in an unlocked (open) position.

[0057] FIG. 28 shows an example sheath stabilizer housing in a locked (closed) position.

[0058] FIGS. 29 A and 29B depict an additional example of a sheath stabilizer system.FIG. 29A shows the sheath stabilizer system decoupled from a sheath hub, whereas FIG. 29B shows the sheath stabilizer system coupled to a sheath hub.DETAILED DESCRIPTION

[0059] 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, configurations, embodiments, and advantages will become apparent to those skilled in the art from the following description. As will be realized, the device and / or methods are capable of other different and obvious aspects, all without departing from the spirit of the inventive concepts. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0060] For purposes of this description, certain advantages and novel features of the aspects and configurations 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.

[0061] Although the operations of exemplary implementations of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that disclosed implementations can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular aspect or implementation are not limited to that aspect or implementation, and may be applied to any aspect or implementation disclosed. It will understood that various changes and additional variations may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention or the inventive concept thereof. Certain aspects and features of any given aspect may be translated to other aspects described herein. In addition, many modifications may be made to adapt a particular situation or device to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular implementations disclosed herein, but that the invention will include all implementations falling within the scope of the appended claims.

[0062] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular implementations, configuration, embodiment orexample of the invention are to be understood to be applicable to any other aspect, configuration, embodiment, or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not restricted to the details of any foregoing aspects. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0063] Throughout this application, various publications and patent applications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this disclosure pertains. However, 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.

[0064] 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.

[0065] The terms "about" and "approximately" are defined as being “close to” as understood by one of ordinary skill in the art. In one non-limiting aspect the terms are definedto be within 10%. In another non-limiting aspect, the terms are defined to be within 5%. In still another non-limiting aspect, the terms are defined to be within 1%.

[0066] "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.

[0067] The terms "coupled," "connected," and the like as used herein mean the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another.

[0068] The words “inner” and “outer” refer to directions toward and away from, respectively, the geometric center of the described feature or device.

[0069] 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.

[0070] “Axially” or “axial” as used herein refers to a direction along the longitudinal axis of the sheath.

[0071] 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.

[0072] Expandable introducer sheaths are disclosed 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 “ExpandableSheath,” 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 / US 2022 / 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 Reversable Bayonet Locking Hub,” U.S. Provisional Application No. 63 / 280,251, entitled “Expandable Sheath Gasket to Provide Hemostasis,” the disclosures of which are herein incorporated by reference.

[0073] Disclosed herein are elongate 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 self-expanding 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 (e.g., stents, stented grafts, balloon catheters for angioplasty procedures, etc.) into many types of vascular and non- vascular body lumens (e.g., veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.). The term “implantable” asused 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.

[0074] FIG. 1 illustrates an exemplary sheath 8 in use with a representative delivery system 10, for delivering an prosthetic device 12, or other type of implantable (e.g., tissue heart valve), to a patient. The delivery system 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 prosthetic device 12 at an implantation site in a patient's body as described in detail below. It is contemplated that the sheath 8 can be used with any type of elongated delivery apparatus used for implanting balloon-expandable prosthetic valves, self-expanding prosthetic valves, and other prosthetic devices.

[0075] As described in more detail below, in general, the sheath 8 comprises an elongate expandable tube that, in use, is inserted into a vessel (e.g., transfemoral vessel, femoral artery, iliac artery) by passing through the skin of patient, such that the distal end of the sheath 8 is inserted into the vessel. Sheath 8 includes a hemostasis valve and / or sealing features at the proximal end of the sheath, e.g., in the sheath hub 20, that provide 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 system 10 is inserted into / through the sheath 8, and the prosthetic device 12 then be delivered and implanted within patient.

[0076] FIGS. 2 and 3, the introducer device / sheath assembly includes a sheath hub 20 at a proximal end of the device and an expandable sheath 8 extending distally from the sheath hub 20. The sheath 8 is coupled to the sheath hub 20 which in turn is removably coupled to a sheath locking system 18. The sheath locking system 18 allows the introducer 6, or other device desired to be removably couped (axially and rotatably) to the sheath 8.

[0077] As illustrated in FIGS. 2-6, the sheath hub 20 can function as a handle for the device. Sheath hub 20 also provides a housing for necessary seal assemblies and an access point for a secondary lumen (e.g., fluid lumen) in fluid communication with the central lumen of the sheath hub 20. The seal assembly 24, as described above and as shown in FIGS. 5A and 5B, is included in the sheath hub 20. The seal assembly 24 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 distal 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 and proximal of the seal assembly 24. They are each openable and closable to provide pressure variation to affect the desired fluid flow from a physician or technician.

[0078] The distal end of the sheath hub 20 includes threads 21 for coupling to a threaded sheath hub cap 22. The sheath 8 is provided between the sheath hub 20 and the sheath hub cap 22 such that coupling the sheath hub cap 22 to the sheath hub 20 fixes the sheath 8 to the sheath hub 20. The sheath hub cap 22 is a cylindrical cap having a cap body having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end. The sheath hub cap 22 has a larger diameter at its proximal end than at its distal end.

[0079] The sheath hub 20 further has receiving slots 48 for coupling the sheath locking system 18, particularly the locking sleeve 28, to the sheath hub 20. The receiving slots 48 are openings which extend around a portion of the diameter of the sheath hub 20 and are sized and configured to accept the interface diameters 66 of the locking sleeve 28. Coupling between the receiving slots 48 and the interface diameters 66 axially and rotationally fixes the locking sleeve 28 and the sheath hub 20 relative to each other.

[0080] FIG. 2 illustrates the sheath 8 of FIG. 1 including a sheath locking system 18 which prevents axial and rotational translation of the introducer 6 with respect to the sheath 8. 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 disclosed herein can also be used to couple the sheath 8 / sheath hub 20 with other delivery system components, catheters, dilators, etc. including the same mating features.

[0081] The sheath locking system 18 keeps the introducer 6 fixed with respect to the sheath 8 during insertion without requiring a physician or technician to hold the introducer 6 and the sheath 8 in place at the distal end. As illustrated in FIGS. 8A-8B, the sheath locking system 18 includes a locking sleeve 28 and an introducer hub 30 (including corresponding introducer 6). The locking sleeve 28 is coupled to the sheath 8 via the sheath hub 20. The locking sleeve 28 engages the introducer hub 30 and is moveable between a locked andunlocked position, thereby fixing the position of the introducer 6 and the sheath 8 and preventing movement therebetween, particularly during insertion into the patient. As will be described in more detail below, 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 during insertion.

[0082] FIGS. 2, 5A-5B and 6, and illustrate the sheath locking sleeve 28 coupled to the introducer hub 30 and the sheath hub 20. As will be described in more detail below, the locking sleeve 28 includes a guide 31 that engages a locking channel 38 provided on the introducer hub 30. The guide 31 moves within the locking channel 38 between an unlocked position, where the sheath locking sleeve 28 is rotationally and axially movable with respect to the introducer hub 30, and a locked position (FIG. 2), where the locking sleeve 28 is axially fixed with respect to the introducer hub 30.

[0083] The locking sleeve 28 is illustrated, for example, in FIGS. 10A-10F. The locking sleeve 28 includes an elongated sleeve body 29 with a central lumen 56 extending longitudinally between the proximal end 58 and distal end 60 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 central lumen 56 has a diameter of at least 0.3”. In some examples, the diameter ranges between 0.3” and 0.6”. Preferably, the diameter is about 0.40”. The distal end 60 of the sleeve body 29 also has a frustoconical outer surface 64 that tapers about the distal end 60 to help with positioning the locking sleeve 28 within the sheath hub 20 and abutting the seal assembly 24 (FIGS. 5B and 5B). The locking sleeve 28 also has a plurality of interface 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. 5A and 6, the distal interface diameters 66 are sized and configured to engage corresponding recesses and / or slots 48 provided in the sheath hub 20 for securing the locking sleeve 28 to the sheath hub 20, and the distal interference diameter 66 seat against the proximal end of the sheath hub 20.

[0084] 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 in the introducer hub 30. The guide 31 extends radially from the outer surface 68 and at least partially around the circumference of the outer surface 68. As provided in FIG. 6, the top surface of the guide 31 does not extend beyond the outer surface of the introducer hub 30when the sheath locking sleeve 28 and the introducer hub 30 are coupled. For example, the height of the guide 31 corresponds to the wall thickness of the introducer hub 30 proximate the guide when the sheath locking sleeve 28 and the introducer hub 30 are coupled. In another example, the top surface of the guide 31 is recessed with respect to the outer surface of the introducer hub 30. That is, the height of the guide 31 is less than the wall thickness of the introducer hub 30. In other examples, the height of the guide 31 is greater than a wall thickness of the introducer hub 30 such that the top surface of the guide 31 extends beyond the outer surface of the introducer hub 30 when the sheath locking sleeve 28 and the introducer hub 30 are coupled. In some examples, the height / axial length of the guide 31 is between about 0.050” and about 0.10.” In some examples that height / axial length of the guide 31 is about 0.075”.

[0085] As illustrated in FIGS. 10D-10F, the guide 31 is a cylindrically shaped projection. However, it is contemplated that the guide 31 may have any other regular or irregular shape that would facilitate movement of the guide 31 within the locking channel 38 of the introducer hub 30. For example, the guide 31 may have an elongated hexagon shape. The guide 31 can have a diameter / width ranging from about 0.05” to about 0.20”. Preferably the guide 31 has a diameter / width of about 0.100”.

[0086] In general, the locking sleeve 28 can be formed from polycarbonate, but in other implementations, the locking sleeve 28 can be formed from rigid plastic, or any other material suitable for providing a strong locking connector for an introducer 6 (metal, composite, etc.)

[0087] FIGS. 2-6 illustrate the introducer hub 30 coupled to the locking sleeve 28. FIGS. 8A-8F show the introducer hub 30 coupled to the introducer 6. FIGS. 9A-9F provide multiple view of the introducer hub 30. As described herein, the introducer 6 is fixedly coupled to the introducer hub 30. The introducer hub 30 couples with the locking sleeve 28 to fix the position the introducer 6 (axially and rotationally) with respect to the locking sleeve 28 / sheath 8. Each of the introducer 6 and introducer hub 30 are described in more detail as follows.

[0088] FIGS. 8A-8F illustrate the introducer hub 30 with the introducer 6 coupled thereto. Example introducer sheaths are described, for example in U.S. Patent Nos. 8,690,936 and 8,790,387, the disclosures of which are incorporated herein by reference. As provided in the cross-section views of FIGS. 5A and 5B, the introducer 6 is coupled to the introducer hub 30and extends beyond the distal end of the introducer hub 30 body and into the sheath 8. When coupled to the sheath hub 20, the introducer 6 extends through the central lumen 56 of the sheath locking sleeve 28, the sheath hub 20 and the central lumen of the sheath 8. As will be descried below, the sheath 8 generally comprises a radially expandable tubular structure. Passage of the introducer 6 through the sheath 8 and into a patient’s vasculature causes the blood vessel to radially expand to about the diameter of the sheath 8. That is, the diameter of the central lumen of the sheath 8 is generally abuts the outer diameter of the introducer 6 such that the introducer 6 provides a mechanism to expand a patient’s vessel to accept the sheath.

[0089] As provided in FIGS. 8A-8F, the introducer 6 is formed as an elongate body with a central lumen extending therethrough. As shown in FIGS. 5 A and 5B, the central lumen of the introducer is aligned with the central lumens of the introducer hub 30, the sheath hub 20 and the sheath 8. The introducer 6 is received within a recessed opening 39 provided on an interior surface of the introducer hub 30, the recessed opening 39 axially aligned with the central lumen 45 of the introducer hub 30. The introducer 6 is coupled to the introducer hub 30 at the recessed opening 39. In an example system, the introducer 6 has a diameter corresponding to, or less than, the diameter of the recessed opening 39. In some examples, the introducer 6 is fixedly coupled to the introducer hub 30 at the recessed opening 39. For example, the introducer 6 is coupled to the recessed opening 39 of the introducer hub 30 by at least one of a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (e.g., an adhesive), a weld, a thermal process, and / or any other suitable coupling process known in the art.

[0090] As described above, the introducer 6 has a central lumen that aligns with the central lumen 45 of the introducer hub 30. This joined lumen allows for the passage of surgical equipment and / or medical devices to the treatment site (e.g., a guide wire). In an example system, and as provided in FIGS. 5A and 5B, the central lumen of the introducer 6 has a diameter corresponding to at least a portion of the diameter of the central lumen 45 of the introducer hub 30. In general, the corresponding diameter portion is adjacent the distal end of the central lumen 45. In other examples, the diameter of the central lumen 45 at the distal end of the introducer hub 30 is slightly larger than the diameter of the central lumen passing through the introducer 6. The central lumen 45 can also define a decreasing tapered portion 41 between the proximal end and the distal end of the introducer hub 30 (see FIG. 6). The corresponding diameter portion and decreasing tapered portion 41 allows for smoothtransition and delivery of surgical equipment and / or medical device through the introducer hub 30 and into the central lumen of the introducer 6.

[0091] As illustrated in FIGS. 9A-9F, the introducer hub 30 includes a hub body 32 having a proximal end 70 and a distal end 72 and defining a central lumen 45 extending therethrough. The hub body 32 has a first (middle) portion 33, a second (distal) portion 35 which extends distally from the first portion 33 and a third (proximal) portion 37 which extends proximally from the first portion 33. The first portion 33 includes the cylindrically- shaped recessed opening 39 for receiving and retaining the introducer 6 and an outer surface 33b. In some examples, the recessed opening 39 has a diameter ranging between 0.15” and about 0.25”. In some examples, the recessed opening 39 has a diameter ranging between 0. 17” and about 0.20”. In some examples, the recessed opening has a diameter of about 0.194”.

[0092] The third (proximal) portion 37 of the introducer hub 30 includes the decreasing tapered portion 41 of the central lumen 45. The decreasing taper portion 41 defining a frustoconical shape with decreasing taper / diameter from the proximal to the distal end of the sheath. It is contemplated that the tapered portion 41 has a minimum diameter of about 0.007” and a maximum diameter of about 0.194”.

[0093] As illustrated in FIG. 5 A and B, when coupled, the central lumen 56 of the locking sleeve 28 is aligned with the central lumen 45 of the introducer hub 30. In some examples, the central lumen 56 of the locking sleeve 28 is coaxial with the central lumen 45 of the introducer hub 30. When coupled, the proximal end of the locking sleeve 28 is received within the central lumen 45 of the introducer hub 30. The proximal end surface of the locking sleeve 28 is adjacent a shoulder 50 provided on an inner surface of the central lumen 45 of the introducer hub 30. As illustrated in FIGS. 5 A and 5B, the central lumen 45 of the introducer hub 30 includes a first portion 52 having a first diameter adjacent the proximal end of the introducer hub 30, and a second portion 54 having a second, larger, diameter adjacent the distal end of the introducer hub 30. The recessed opening 39 can be considered either a component of the first portion 52 of the central lumen 45, or a separate component of the central lumen 45 located between the first (proximal) portion 52 and the second (distal) portion 54. When the locking sleeve 28 and introducer hub 30 are coupled, at least a portion of the sleeve body 29 of the sheath locking sleeve 28 is received within the second portion 54 (larger portion) of the central lumen 45 of the introducer hub 30. The central lumen 56 of thesheath locking sleeve 28 is aligned with the central lumen 45 of the introducer hub 30 such that they are co-axial and form a smooth inner surface along the combined central lumens of the introducer hub 30 and the sheath locking sleeve 28.

[0094] As described generally above, the locking sleeve 28 couples to the introducer hub 30 via engagement between the guide 31 on the locking sleeve 28 and the locking channel 38 provided in the introducer hub 30. As provided in FIGS. 9A-9F, the introducer hub 30 includes two locking channels 38. However, it is contemplated that the introducer hub 30 can include one locking channel 38 or more than two locking channels 38. The locking channel 38 can be is formed a recess or groove in a surface of the introducer 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 hub 30. Illustrated in FIG. 9B, the locking channels 38 provide an interface to secure the sheath locking sleeve 28 to the introducer hub 30 and ensure a fixed axial position between the introducer 6 and the sheath 8.

[0095] The locking channel 38 is formed on the distal end of the introducer hub 30. The locking channel 38 includes an opening on the distal end surface that leads to an angled guide portion 40 that transitions to a locking portion 42. The guide portion 40 is configured to direct the guide 31 of the locking sleeve 28 in an axial and circumferential direction along the side wall of the guide portion 40 towards the locking portion 42 upon rotation of the introducer hub 30 and / or the sheath locking sleeve 28. The locking portion 42 is configured to securely engage the guide 31, fixing the axial position of the introducer hub 30 with respect to the sheath locking sleeve 28. As illustrated in FIG. 9B, the guide portion 40 of the locking channel 38 extends from the distal end of the introducer hub 30 axially towards the proximal end of the introducer hub 30 and circumferentially around the introducer hub 30. For example, the guide portion 40 of the locking channel 38 can be described as extending helically around / along a length of the introducer hub 30 or on an angle from the distal end of the introducer hub 30.

[0096] As illustrated in FIGS. 9B and 9D, the locking portion 42 of the locking channel 38 extends at an angle from the end of the guide portion 40. As provided in FIG. 9B, the angle between the centerline of the guide portion 40 and the centerline of the locking portion 42 is greater than 90-degrees. In another example, the angle between the centerline of the guide portion 40 and the centerline of the locking portion 42 is about 120-degrees. In an examplesystem, the locking portion 42 extends around a portion of the circumference of the introducer hub 30. The locking portion 42 can extend parallel to the distal end of the introducer hub 30. In an example system, the length of the guide portion 40 (measured along its centerline) is greater than a length of the locking portion 42 (measured along its centerline). In another example, the length of the guide portion 40 equals or is less than a length of the locking portion 42.

[0097] The locking portion 42 can include a catch 44 for securing the guide 31 within the locking portion 42 of the locking channel 38 and forming a partial barrier for the guide 31 within the locking portion 42. As illustrated in FIG. 9B, the catch 44 includes a projection that extends from a side wall 74 of the locking portion 42 and releasably secures the guide 31 within the locking channel 38. The catch 44 extends from the side wall 42a of the locking portion 42 in a proximal direction towards the center line of the locking portion 42 and has a height sufficient to retain the guide 31 between the catch 44 and the end of the locking portion 42.

[0098] The distal end surface 72 of the introducer hub 30 can include features for biasing the guide 31 towards the locking channel 38. For example, the distal end of the introducer hub 30 can include a tapered surface angled toward an opening of the locking channel 38. As illustrated in FIG. 9B, the distal end 72 of the introducer hub 30 includes a first tapered surface 76 (angled towards a leading edge of the opening of the locking channel 38 and a second tapered surface 78 angled towards the trailing edge of the opening of the locking channel 38.

[0099] In use, engagement between the guide 31 and the guide portion 40 of the locking channel 38 is configured to bias the locking sleeve 28 in a proximal axial direction toward the proximal end 70 of the introducer hub 30 (towards a locked position) when the sheath locking sleeve 28 is rotated in a first axial direction. In this direction the guide 31 advances toward the locking portion 42 of the locking channel 38 into the locked position. Alternatively, engagement between the guide 31 and the locking portion 42 of the locking channel 38 is configured to bias the locking sleeve 28 in a distal axial direction toward the distal end of the introducer hub 30 (towards an unlocked position) when the sheath locking sleeve 28 is rotated in a second (opposite) axial direction. In the second direction, the guide 31 advances away from the locking portion 42 of the locking channel 38, to the unlocked position. When the guide 31 is in the locked position and retained with by locking portion 42 by catch 44,rotation in the second direction causes the guide 31 to bias against the catch 44 overcoming the oppositional forces of the catch 44, and moving the guide 31 from the locked to the unlocked position.

[0100] As illustrated in FIGS. 8A-9F, the outer surface of the introducer hub body 32 includes gripping features and / or surfaces for a physician or technician to use when manipulating the introducer hub 30. As provided in FIG. 9B, the introducer hub body 32 can include a two recessed gripping surfaces 34 on opposite sides of the longitudinal axis of the introducer hub 30. When the introducer hub 30 is viewed from the side, the gripping surfaces 34 define a shape having a smaller diameter / width center portion and larger diameter / width end portions, e.g. dog-bone / barbell shape to the hub body 32. In an example system, the gripping surfaces 34 are provided along at least 40% of the length of the introducer hub body 32. In another example, the gripping surfaces 34 are provided along at least 50% of the length of the introducer hub body 32.

[0101] In general, the introducer hub 30 can be formed from polycarbonate, but in other implementations the introducer hub 30 can be formed from rigid plastic, or any other material suitable for providing a locking mechanism for an introducer 6 (metal, composite, etc.).

[0102] As noted above, introducer / access sheaths are usually designed with the femoral approach in mind, but this does not suit them well for alternative approaches (such as carotid, subclavian, and axillary approaches). Namely, introducer sheaths are typically long enough to extend up through the femoral artery and into the abdominal aorta. When these long sheaths are inserted at positions closer to the heart, the excess length of the sheath is left dangling outside of the patient’s body, as shown in FIG. 24. This can produce stress at the access point, leading to sheath kinking and overall poor usability. Furthermore, the instability created by the dangling excess length can damage internal vascular structures like the aortic root. Furthermore, the sheath hub is farther from the incision site when using these alternative approaches. This creates challenges in keeping the sheath stationary because the hub cannot be sutured to the patient. As such, an additional healthcare worker is required to hold the sheath in place during the procedure. The sheath stabilizing systems disclosed herein address these problems by improving the availability of space for other equipment and people in the procedure room, preventing movement of the length of the sheath and / or delivery system that extends outside of the patient reducing the risk of possible injury to the patient and / or damage the system, helps to prevent surgeon strain / fatigue by providingadditional support for the sheath / delivery system, and helps to ensure sterility of by positioning the portions of the sheath and / or or delivery system above the sterile barrier (e.g., sterile surgical drape) when used. Note that while this disclosure is described in the context of alternative vascular approaches (such as but not limited to the carotid, subclavian, and axillary approaches), similar devices, systems, and methods could be utilized with the femoral approach, according to physician discretion (for example, with smaller patients, during pediatric procedures, or during veterinary procedures).

[0103] FIG. 25 shows an example stabilizer system 1000 for stabilizing a sheath, the stabilizer system 1000 comprising a sheath 8 having a proximal end 314, a distal end 310 and a central lumen 312 extending therethrough. As described herein, the sheath 8 is coupled to sheath hub 340 at its proximal end 314 and locked in place on the sheath hub 340 via hub cap 320. FIG. 25 also shows the sheath stabilizer housing 480, positioning arm 510, and static platform 520 decoupled from the sheath hub 340. Note that sheath 8, hub cap 320, and sheath hub 340 can bear similarities to the implementations described above with respect to FIGS. 1-23. However, variations in the structure of these components will not preclude the use of the stabilizer system 1000 to prevent movement of the length of a sheath that extends outside of the patient.

[0104] FIG. 26 shows the example stabilizer system 1000 for stabilizing sheath 8 coupled and ready for a procedure. Positioning arm 510 is coupled at a first end 512 to a static platform 520, and extends to second end 514. In some examples the positioning arm 510 is freely movable / articulating with respect to the static platform 520, while in some examples the positioning arm 510 has limited movement with respect to the static platform 520. Second end 514 is coupled to stabilizer housing 480, which extends partially around sheath hub 340 and hub cap 320. This setup immobilizes sheath 8 and facilitates the remainder of the procedure. The static platform 520 can be a movable platform positioned under a patient, or it may be a bed or other platform that the patient rests upon directly. The first end 512 of the positioning arm 510 may be coupled to the static platform 520 via a variety of types of fasteners. Alternatively, the positioning arm 510 can be unitary with the platform 520. The second end 514 of positioning arm 510 can be separable from or unitary with stabilizer housing 480. Furthermore, while the devices depicted in FIGS. 25-29B show a stabilizer housing 480 used with a sheath hub 340 that includes a hub cap 320, it should be understoodthat the stabilizer system 1000 may be modified for use sheath hubs that do not include a hub cap 320.

[0105] A first example stabilizer housing 480 is shown in FIGS. 27. FIG. 27 shows the stabilizer housing 480 in an unlocked (open) position. As shown in FIG. 27, the stabilizer housing 480 has a proximal end 482, a distal end 484, and a central space 486 is defined by inner surfaces of stabilizer housing 480. FIG. 26 shows the stabilizer housing 480 in the locked position (locked around sheath hub 340 and hub cap 320). In FIG. 26, sheath hub 340 and hub cap 320 are enclosed in the central space 486 of stabilizer housing 480. The inner surfaces of stabilizer housing 480 are generally sized and shaped to complement / corresponding to the outer surface of the sheath hub 340, hub cap 320 and / or sheath 8. This coordination helps to ensure a secure fit between the stabilizer housing 480 and the sheath hub 340 hub cap 320 and / or sheath 8 helping immobilize the sheath 8 with respect to the stabilizer housing 480 in the locked position. FIG. 28 shows the stabilizer housing 480 in a locked (closed) position without the sheath hub 340. The walls of stabilizer housing 480 extend circumferentially. In some examples, portions the walls of the stabilizer housing 480 extend only but only partially around the sheath hub 340, hub cap 320 and / or sheath 8. This allows stabilizer housing 480 to define a port opening 508 that receives the port 350 (e.g., a fluid port) extending from the sheath hub 340.

[0106] The stabilizer housing 480 of FIGS. 27 and 28 includes a first shell body 488 and a second shell body 494 that can move with respect to each other, opening and closing in a clamshell fashion. The first shell body 488 and the second shell body 494 come together to create a generally cylindrical form when stabilizer housing 480 is in the locked, closed position. Each shell body 488, 494 is partially cylindrical, extending in a curved fashion between two longitudinally extending edges. The first longitudinal edge 490 of first shell body 488 is hingedly coupled to the first longitudinal edge 496 of the second shell body 494. In the open, unlocked position, the second longitudinal edge 492 of the first shell body 488 and the second longitudinal edge 498 of the second shell body 494 are spaced apart. In the locked position, the second longitudinal edge 492 of the first shell body 488 engages the second longitudinal edge 498 of the second shell body 494. In the example of FIGS. 27 and 28, port opening 508 is defined when second longitudinal edge 492 of the first shell body 488 and the second longitudinal edge 498 of the second shell body 494 meet in the locked position. The second longitudinal edge 492 of the first shell body 488 and the secondlongitudinal edge 498 of the second shell body 494 can be equipped with any variety of complementary fastening features, including, but not limited to, tab 506 and corresponding socket 507.

[0107] As shown in FIGS. 27 and 28, the interior surfaces of stabilizer housing 480 is generally sized and shaped to correspond in shape to the outer surfaces of sheath hub 340, hub cap 320, and / or sheath 8. This helps create a tight fit that facilitates the immobilization of the sheath 8 with respect to the patient when the stabilizer housing 480 is in the closed configuration. For example, as shown in FIG. 28, the locked position diameter (DSD) of the central space 486 at the distal end 484 of stabilizer housing 480 can correspond to and / or be just slightly larger than the outer diameter at or near proximal end 314 of the sheath 8. Similarly, a locked position diameter (DSP) of the central space 486 at the proximal end 482 of stabilizer housing 480 can correspond to and / or be just slightly larger than the diameter (DSH) of the sheath hub 340. An inner surface near the distal end 484 of the stabilizer housing 480 can include a shelf 582 that abuts the distal end 326 of hub cap 320 to prevent the hub cap 320 (and coupled sheath 8) from moving distally when the stabilizer housing 480 is in the locked position.

[0108] As shown in FIG. 27, the stabilizer housing 480 can define a positioning arm opening 502 that is shaped to couple with the positioning arm 510. While the positioning arm opening 502 could feasibly be located in multiple locations on the stabilizer housing 480, in the implementation of FIG. 27, the positioning arm opening 502 is defined by the first shell body 488 near its proximal end 482. In some examples, positioning arm opening 502 includes a recess 504 that is sized and configured to receive a locking nut 516, which is disposed near the distal end 514 of the positioning arm 510 (as shown in FIG. 25). While the depicted implementation shows a coupling that uses a locking nut 516 placed in positioning arm opening 502, the positioning arm 510 could feasibly be coupled to the stabilizer housing 480 in a variety of other ways, including clips, pins, threads, magnets, snap features, or other types of fasteners. Alternatively, positioning arm 510 could be a unitary structure with stabilizer housing 480.

[0109] FIGS. 29A and 29B depict an additional example of a stabilizer housing 480. FIG. 29A shows stabilizer housing 480 without a coupled sheath hub 340, whereas FIG. 29B shows the stabilizer housing 480 coupled to sheath hub 340 and hub cap 320. Here, the sheath hub 340 snaps into the stabilizer housing 480. For example, the sheath hub 340 canbe coupled to the stabilizer housing 480 by an interference fit. An inner surface of stabilizer housing 480 curves in a partial arc to form central space 486, which accommodates sheath hub 340. A return latch 602 helps hold sheath hub 340 in place in the locked position by pressing sheath hub 340 against the inner surface of stabilizer housing 480. In some examples, the return latch 602 is biased toward a neutral position wherein return latch 602 extends partially into central space 486. In some implementations, the bias can result from an internal spring mechanism or a shape memory. Return latch 602 is slidable toward a retracted position (shown in FIG. 29A by double-arrows extending along axis of positioning arm 510.) When return latch 602 is in the retracted position, it moves away from central space 486 such that stabilizer housing 480 is in the unlocked position and can accept sheath hub 340. The return latch 602 is shown as positioned between second end 514 of positioning arm 510 and the stabilizer housing 480, but could be positioned in other locations on the stabilizer housing 480.

[0110] The positioning arm 510 of FIGS. 29A and FIG. 29B includes a locking mechanism 604 that enables positioning arm 510 to be transitioned between a locked and an unlocked configuration. Moving the locking mechanism 604 to the unlocked configuration allows for adjustments / movement of the sheath 8 / delivery system during the procedure. That is, when the positioning arm 510 is locked, the sheath 8 coupled to the stabilizer housing 480 cannot move, and when the positioning arm 510 is unlocked, the sheath 8 can move together as a unit with the stabilizer housing 480 and the positioning arm 510. The positioning arm 510 can be transitioned between the locked and unlocked configuration through a single hand operation, which, in some implementations, is close to the stabilizer housing 480. For example, in the depicted implementation, an internal locking mechanism is activated and deactivated by locking button 604. Locking button 604 is depicted as positioned on second end 514 of the positioning arm 510, but could alternatively be positioned anywhere on the positioning arm 510 or stabilizer housing 480. Locking mechanisms can include, for example, sliders, pins, levers, knobs, dials, cams, magnets, latches, bolts and / or clamps.

[0111] In some implementations, the stabilizer housing 480 can be sized and configured to provide a complementary snap fit with the sheath hub 340, the hub cap 320, or both. For example, the inner surfaces of stabilizer housing 480 might create an arc of greater than 180 degrees in profile, but leaving an entry slot through which sheath hub 340 and / or hub cap 320 could be pressed into central space 486. Alternatively, a stabilizer housing 480 might haveinner surfaces that extend a full 360 degrees around central space 486, but also have an open proximal end 482 or an open distal end 488 to allow sheath hub 340, the hub cap 320, and / or the sheath 8 to slide into place. Such an implementation might be used with or without additional locking mechanisms (such as, but not limited to, a return latch 602), and such additional locking mechanisms might be positioned anywhere on the inner or outer surfaces of stabilizer housing 480.

[0112] As described above, the introducer device / sheath assembly includes an expandable sheath 8 extending distally from the sheath hub 20. The expandable sheath 8 has a central lumen to guide passage of the delivery system 10 for the prosthetic device 12 / prosthetic heart valve. In an alternative implementation, the introducer device / sheath assembly need not include the sheath hub 20. For example, the sheath 8 can be an integral part of a component of the sheath assembly, such as the guide catheter. As described above, the sheath 8 can have a natural, unexpanded outer diameter that will expand locally upon passage of the prosthetic device 12.

[0113] In certain implementation, the expandable sheath 8 can comprise a plurality of coaxial layers extending along at least a portion of the length of the sheath 8. The structure of the coaxial layers is described in more detail below with respect to FIGS. 11-23. Example expandable sheaths including coaxial layers are described, for example, in U.S. Patent Application No. 16 / 378,417, entitled “Expandable Sheath,” and U.S. Patent Application No. 17 / 716,882, entitled “Expandable Sheath,” the disclosures of which are herein incorporated by reference.

[0114] Various aspects of the coaxial layered structure of the sheath 8 are described herein. For example, in reference to the example sheath 8 illustrated in FIGS. 11-14, the expandable sheath 8 can include a number of layers including an inner layer 102 (also referred to as an inner layer), a second layer 104 disposed around and radially outward of the inner layer 102, a third layer 106 disposed around and radially outward of the second layer 104, and a fourth outer layer 108 (also referred to as an outer layer) disposed around and radially outward of the third layer 106. In the illustrated configuration, the inner layer 102 can define the lumen 112 of the sheath extending along a central axis 114 through which the delivery apparatus travels into the patient’s vessel in order to deliver, remove, repair, and / or replace a prosthetic device, moving in a direction along the longitudinal axis of the sheath 8.

[0115] Referring to FIG. 12, when the sheath 8 is in an unexpanded state, various layers of the sheath, e.g., the inner layer 102 and / or the outer layer 108, can form longitudinally - extending folds or creases such that the surface of the sheath comprises a plurality of ridges 126 (also referred to herein as “folds”). The ridges 126 can be circumferentially spaced apart from each other by longitudinally -extending valleys 128. When the sheath expands beyond its natural diameter Di, the ridges 126 and the valleys 128 can level out or be taken up as the surface radially expands and the circumference increases, as further described below. When the sheath 8 collapses back to its natural diameter, the ridges 126 and valleys 128 can reform.

[0116] In certain implementations, the inner layer 102 and / or the outer layer 108 can comprise a relatively thin layer of polymeric material. For example, in some implementations the thickness of the inner layer 102 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm. In certain implementations, the thickness of the outer layer 108 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm.

[0117] In certain examples, the inner layer 102 and / or the outer layer 108 can comprise a lubricious, low-friction, and / or relatively non-elastic material. In particular implementations, the inner layer 102 and / or the outer layer 108 can comprise a polymeric material having a modulus of elasticity of 400 MPa or greater. Exemplary materials can include ultra-high- molecular-weight polyethylene (UHMWPE) (e.g., Dyneema®), high-molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK). With regard to the inner layer 102 in particular, such low coefficient of friction materials can facilitate passage of the prosthetic device through the lumen 112. Other suitable materials for the inner and outer layers can include polyimide, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyamide, polyether block amide (e.g., Pebax), and / or combinations of any of the above. Some implementations the sheath 8 can include a lubricious liner on the inner surface of the inner layer 102. Examples of suitable lubricious liners include materials that can further reduce the coefficient of friction of the inner layer 102, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof. Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of 0.1 or less.

[0118] Additionally, some implementations of the sheath 8 can include an exterior hydrophilic coating on the outer surface of the outer layer 108. Such a hydrophilic coating can facilitate insertion of the sheath 8 into a patient’s vessel, reducing potential damage.Examples of suitable hydrophilic coatings include the Harmony™ Advanced Lubricity Coatings and other Advanced Hydrophilic Coatings available from SurModics, Inc., Eden Prairie, MN. DSM medical coatings (available from Koninklijke DSM N.V., Heerlen, the Netherlands), as well as other hydrophilic coatings (e.g., PTFE, polyethylene, polyvinylidine fluoride), are also suitable for use with the sheath 8. Such hydrophilic coatings may also be included on the inner surface of the inner layer 102 to reduce friction between the sheath and the delivery system, thereby facilitating use and improving safety. In some implementations, a hydrophobic coating, such as Perylene, may be used on the outer surface of the outer layer 108 or the inner surface of the inner layer 102 in order to reduce friction.

[0119] In certain implementations, the second layer 104 can be a braided layer. FIGS. 13A and 13B illustrate the sheath 8 with the outer layer 108 removed to expose the elastic third layer 106. With reference to FIGS. 13A and 13B, the braided second layer 104 can comprise a plurality of members or filaments 110 (e.g., metallic or synthetic wires or fibers) braided together. The braided second layer 104 can have any desired number of filaments 110, which can be oriented and braided together along any suitable number of axes. For example, with reference to FIG. 13B, the filaments 110 can include a first set of filaments 110A oriented parallel to a first axis A, and a second set of filaments 110B oriented parallel to a second axis B. The filaments 110A and HOB can be braided together in a biaxial braid such that filaments 110A oriented along axis A form an angle 0 with the filaments HOB oriented along axis B. In certain implementations, the angle 0 can be from 5° to 70°, 10° to 60°, 10° to 50°, or 10° to 45°. In the illustrated example, the angle 0 is 45°. In other implementations, the filaments 110 can also be oriented along three axes and braided in a triaxial braid, or oriented along any number of axes and braided in any suitable braid pattern. The braided second layer 104 can extend along substantially the entire length L of the sheath 8, or alternatively, can extend only along a portion of the length of the sheath. In particular implementations, the filaments 110 can be wires made from metal (e.g., Nitinol, stainless steel, etc.), or any of various polymers or polymer composite materials, such as carbon fiber. In certain implementations, the filaments 110 can be round, and can have a diameter of from 0.01 mm to 0.5 mm, 0.03 mm to 0.4 mm, or 0.05 mm to 0.25 mm. In other implementations, the filaments 110 can have a flat cross-section with dimensions of 0.01 mm x 0.01 mm to 0.5 mm x 0.5 mm, or 0.05 mm x 0.05 mm to 0.25 mm x 0.25 mm. In one implementation, filaments 110 having a flat cross-section can have dimensions of 0. 1 mm x 0.2 mm. However, othergeometries and sizes are also suitable for certain implementations. If braided wire is used, the braid density can be varied. Some implementations have a braid density of from ten picks per inch to eighty picks per inch, and can include eight wires, sixteen wires, or up to fifty-two wires in various braid patterns. In other implementations, the second layer 104 can be laser cut from a tube, or laser-cut, stamped, punched, etc., from sheet stock and rolled into a tubular configuration. The second layer 104 can also be woven or knitted, as desired.

[0120] The third layer 106 can be a resilient, elastic layer (also referred to as an elastic material layer). In certain implementations, the elastic third layer 106 can be configured to apply radially inward force to the underlying layers 102 and 104 in a radial direction (e.g., toward the central axis 114 of the sheath) when the sheath expands beyond its natural diameter by passage of the delivery apparatus through the sheath. Stated differently, the elastic third layer 106 can be configured to apply encircling / radially inward pressure to the layers of the sheath beneath the elastic third layer 106 to counteract expansion of the sheath. The radially inwardly directed force is sufficient to cause the sheath to collapse radially back to its unexpanded state after the delivery apparatus is passed through the sheath.

[0121] In the illustrated example, the elastic third layer 106 can comprise one or more members configured as strands, ribbons, or bands 116 helically wrapped around the braided second layer 104. For example, in the illustrated implementation the elastic third layer 106 comprises two elastic bands 116A and 116B wrapped around the braided second layer 104 with opposite helicity, although the elastic layer may comprise any number of bands depending upon the desired characteristics. The elastic bands 116A and 116B can be made from, for example, any of a variety of natural or synthetic elastomers, including silicone rubber, natural rubber, any of various thermoplastic elastomers, polyurethanes such as polyurethane siloxane copolymers, urethane, plasticized polyvinyl chloride (PVC), styrenic block copolymers, polyolefin elastomers, etc. In some implementations, the elastic layer can comprise an elastomeric material having a modulus of elasticity of 200 MPa or less. In some implementations, the elastic third layer 106 can comprise a material exhibiting an elongation to break of 200% or greater, or an elongation to break of 400% or greater. The elastic third layer 106 can also take other forms, such as a tubular layer comprising an elastomeric material, a mesh, a shrinkable polymer layer such as a heat-shrink tubing layer, etc. In lieu of, or in addition to, the elastic third layer 106, the sheath 8 may also include an elastomeric or heat-shrink tubing layer around the outer layer 108. Examples of such elastomeric layers areZ1disclosed in U.S. Publication No. 2014 / 0379067, U.S. Publication No. 2016 / 0296730, and U.S. Publication No. 2018 / 0008407, which are incorporated herein by reference. In other implementations, the elastic third layer 106 can also be radially outward of the polymeric outer layer 108.

[0122] In certain implementations, one or both of the inner layer 102 and / or the outer layer 108 can be configured to resist axial elongation of the sheath 8 when the sheath expands. More particularly, one or both of the inner layer 102 and / or the outer layer 108 can resist stretching against longitudinal forces caused by friction between a prosthetic device and the inner surface of the sheath 8 such that the length L remains substantially constant as the sheath expands and contracts. As used herein with reference to the length L of the sheath, the term “substantially constant” means that the length L of the sheath increases by not more than 1%, by not more than 5%, by not more than 10%, by not more than 15%, or by not more than 20%. Meanwhile, with reference to FIG. 13B, the filaments 110A and HOB of the braided second layer 104 can be allowed to move angularly relative to each other such that the angle 0 changes as the sheath expands and contracts. This, in combination with the longitudinal folds 126 in the layers 102 and 108, can allow the lumen 112 of the sheath to expand as a prosthetic device is advanced through it.

[0123] For example, in some implementations the inner layer 102 and the outer layer 108 can be heat-bonded during the manufacturing process such that the braided second layer 104 and the elastic third layer 106 are encapsulated between the layers 102 and 108. More specifically, in certain implementations the inner layer 102 and the outer layer 108 can be adhered to each other through the spaces between the filaments 110 of the braided second layer 104 and / or the spaces between the elastic bands 116. The layers 102 and 108 can also be bonded or adhered together at the proximal and / or distal ends of the sheath. In certain implementations, the layers 102 and 108 are not adhered to the filaments 110. This can allow the filaments 110 to move angularly relative to each other, and relative to the layers 102 and 108, allowing the diameter of the braided second layer 104, and thereby the diameter of the sheath, to increase or decrease. As the angle 0 between the filaments 110A and 110B changes, the length of the braided second layer 104 can also change. For example, as the angle 0 increases, the braided second layer 104 can foreshorten, and as the angle 0 decreases, the braided second layer 104 can lengthen to the extent permitted by the areas where the layers 102 and 108 are bonded. However, because the braided second layer 104 is notadhered to the layers 102 and 108, the change in length of the braided layer that accompanies a change in the angle 0 between the filaments 110A and 110B does not result in a significant change in the length L of the sheath.

[0124] FIG. 14 illustrates radial expansion of the sheath 8 as a prosthetic device (e.g., implant 12) is passed through the sheath 8 in the direction of arrow 132 (e.g., distally). As the prosthetic device (implant 12) is advanced through the sheath 8, the sheath can resiliently expand to a second diameter D2 that corresponds to a size or diameter of the prosthetic device. As the prosthetic device (implant 12) is advanced through the sheath 8, the prosthetic device can apply longitudinal force to the sheath in the direction of motion by virtue of the frictional contact between the prosthetic device and the inner surface of the sheath. However, as noted above, the inner layer 102 and / or the outer layer 108 can resist axial elongation such that the length L of the sheath remains constant, or substantially constant. This can reduce or prevent the braided layer second 104 from lengthening, and thereby constricting the lumen 112.

[0125] Meanwhile, the angle 0 between the filaments 110A and 110B can increase as the sheath expands to the second diameter D2 to accommodate the prosthetic valve. This can cause the braided second layer 104 to foreshorten. However, because the filaments 110 are not engaged or adhered to the layers 102 or 108, the shortening of the braided second layer 104 attendant to an increase in the angle 0 does not affect the overall length L of the sheath. Moreover, because of the longitudinally -extending folds 126 formed in the layers 102 and 108, the layers 102 and 108 can expand to the second diameter D2 without rupturing, in spite of being relatively thin and relatively non-elastic. In this manner, the sheath 8 can resiliently expand from its natural diameter Di to a second diameter D2 that is larger than the diameter Di as a prosthetic device is advanced through the sheath, without lengthening, and without constricting. Thus, the force required to push the prosthetic implant through the sheath is significantly reduced.

[0126] Additionally, because of the radial force applied by the elastic third layer 106, the radial expansion of the sheath 8 can be localized to the specific portion of the sheath occupied by the prosthetic device. For example, with reference to FIG. 14, as the prosthetic device (implant 12) moves distally through the sheath 8, the portion of the sheath immediately proximal to the prosthetic device (e.g., implant 12) can radially collapse back to the initial diameter Di under the influence of the elastic third layer 106. The layers 102 and 108 canalso buckle as the circumference of the sheath is reduced, causing the ridges 126 and the valleys 128 to reform. This can reduce the size of the sheath required to introduce a prosthetic device of a given size. Additionally, the temporary, localized nature of the expansion can reduce trauma to the blood vessel into which the sheath is inserted, along with the surrounding tissue, because only the portion of the sheath occupied by the prosthetic device expands beyond the sheath’s natural diameter and the sheath collapses back to the initial diameter once the device has passed. This limits the amount of tissue that must be stretched in order to introduce the prosthetic device, and the amount of time for which a given portion of the vessel must be dilated.

[0127] In another example layered sheath 8 structure, FIGS. 15-23 illustrate various features of the coaxial layered structure of the expandable sheath 8 of FIG. 1 according to another implementation. Similar reference numbers are used to describe like elements. It is to be understood that the variations (e.g., materials and alternate configurations) described above with reference to FIGS. 11-14 can also apply to the example shown in FIGS. 15-23. Furthermore, the variations described below with reference to FIGS. 15-23 can also be applied to the sheath described in FIGS. 11-14.

[0128] Similar to various implementations of the sheath 8 described above in reference to FIGS. 11-14, the sheath 8 of FIGS. 15-23 includes a plurality of layers. For example, the sheath 8 illustrated in FIGS. 15-23 also includes an inner layer 202 and an outer layer 204 disposed around the inner layer 202. The inner layer 202 can define a lumen 212 through which the delivery apparatus travels into the patient’s vessel in order to deliver, remove, repair, and / or replace a prosthetic device, moving in a direction along the longitudinal axis X. Similar to the sheath illustrated in FIGS. 11-14, as the prosthetic device passes through the sheath 8, the sheath 8 locally expands from a first, resting / unexpanded diameter to a second, expanded diameter to accommodate the prosthetic device. After the prosthetic device passes through a particular location of the sheath 8, each successive expanded portion or segment of the sheath 8 at least partially returns to the smaller, resting / unexpanded diameter. In this manner, the sheath 8 can be considered self-expanding, in that it does not require use of a balloon, dilator, and / or obturator to expand.

[0129] Similar to the examples above, the inner and outer layers 202, 204 can comprise any suitable materials. Suitable materials for the inner layer 202 include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene,polyether block amide (e.g., Pebax), and / or combinations thereof. In one specific implementation the inner layer 202 can comprise a lubricious, low-friction, or hydrophilic material, such as PTFE. Such low coefficient of friction materials can facilitate passage of the prosthetic device through the lumen defined by the inner layer 202. In some examples, the inner layer 202 can have a coefficient of friction of less than about 0.1. Some examples of the sheath 8 can include a lubricious liner on the inner surface of the inner layer 202. Examples of suitable lubricious liners include materials that can further reduce the coefficient of friction of the inner layer 202, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof. Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of about 0.1 or less.

[0130] Suitable materials for the outer layer 204 include nylon, polyethylene, Pebax, HDPE, polyurethanes (e.g., Tecoflex), and other medical grade materials. In one implementation, the outer layer 204 can comprise high density polyethylene (HDPE) and Tecoflex (or other polyurethane material) extruded as a composite. In some implementations, the Tecoflex can act as an adhesive between the inner layer 202 and the outer layer 204 and may only be present along a portion of the inner surface of the outer layer 204. Other suitable materials for the inner and outer layers are also disclosed in U.S. Patent Nos. 8,690,936 and 8,790,387, which are incorporated herein by reference.

[0131] Additionally, some examples of the sheath 8 include an exterior hydrophilic coating on the outer surface of the outer layer 204. Such a hydrophilic coating can facilitate insertion of the sheath 100 into a patient’s vessel. Examples of suitable hydrophilic coatings include the Harmony™ Advanced Lubricity Coatings and other Advanced Hydrophilic Coatings available from SurModics, Inc., Eden Prairie, MN. DSM medical coatings (available from Koninklijke DSM N.V., Heerlen, the Netherlands), as well as other hydrophilic coatings (e.g., PTFE, polyethylene, polyvinylidene fluoride), are also suitable for use with the sheath 100.

[0132] FIG. 16 provides a partial cross-section of the distal end of the sheath 8 along section line 16-16 identified in FIG. 15. As described herein, the sheath 8 can be inserted into a vessel (e.g., the femoral or iliac arteries) by passing through the skin of patient, such that a soft tip portion 206 at the distal end 210 of the sheath 8 is inserted into the vessel. As best seen in FIG. 16, the soft tip portion 206 can comprise, in some examples, low density polyethylene (LDPE) and can be configured to minimize trauma or damage to the patient’svessels as the sheath is navigated through the vasculature. For example, the soft tip portion 206 can be slightly tapered to facilitate passage through the vessels. The soft tip portion 206 can be secured to the distal end 210 of the sheath 8, such as by thermally bonding the soft tip portion 206 to the inner and outer layers of the sheath 8. Such a soft tip portion 206 can be provided with a lower hardness than the other portions of the sheath 8. In some examples, the soft tip 206 can have a Shore hardness from about 25 D to about 40 D. The tip portion 206 is configured to be radially expandable to allow a prosthetic device to pass through the distal opening of the sheath 208. For example, the tip portion 206 can be formed with a weakened portion, such as an axially extending score line or perforated line that is configured to split and allow the tip portion 206 to expand radially when the prosthetic device passes therethrough.

[0133] FIG. 17 shows a cross-section view of the sheath 8 taken near the distal end 210 of the sheath 8 as indicated by section line 17-17 in FIG. 16. As illustrated in FIGS. 16 and 17, the sheath 8 can include at least one radiopaque filler or marker, such as a discontinuous, or C-shaped, band 216 positioned near the distal end 210 of the sheath 8. The marker 216 can be associated with the inner and / or outer layers 202, 204 of the sheath 8. For example, as shown in FIG. 17, the marker 216 can be positioned between the inner layer 202 and the outer layer 204. In alternative examples, the marker 216 can be associated with the outer surface of the outer layer 204. In some examples, the marker 216 can be embedded or blended within the inner or outer layers 202, 204.

[0134] FIGS. 18 and 19 show additional cross sections taken at different points along the sheath 208. FIG. 18 shows a cross-section of a segment of the sheath near the proximal end 214 of the sheath 8, as indicated by section line 18-18 in FIG. 15. At this location, the sheath 8 includes the inner layer 202, outer layer 204, elastic outer layer 250 / outer jacket, and the strain relief layer 26. At this location, near the proximal end of the sheath 8, the inner and outer layers 202, 204 are substantially tubular. Here the inner and outer layers 202, 204 can be formed without any slits or folded portions in the layers. By contrast, as described below, the inner and outer layers 202, 204 at different locations along the sheath 8 (e.g., at the point indicated by section line 19-19 in FIG. 15 and / or the point indicated by section line 22-22 in FIG. 21) can have a different configuration.

[0135] As shown in FIG. 19, the inner layer 202 can be arranged to form a substantially cylindrical lumen 212 therethrough. Inner layer 202 can include one or more folded portions218. In the implementation shown in FIG. 19, inner layer 202 is arranged to have one folded portion 218 that can be positioned on either side of the inner layer 202. Inner layer 202 can be continuous, in that there are no breaks, slits, or perforations in inner layer 202. Outer layer 204 can be arranged in an overlapping fashion such that an overlapping portion 220 overlaps at least a part of the folded portion 218 of the inner layer 202. As shown in FIG. 19, the overlapping portion 220 also overlaps an underlying portion 222 of the outer layer 204. The underlying portion 222 can be positioned to underlie both the overlapping portion 220 of the outer layer 204, as well as the folded portion 218 of the inner layer 202. Thus, the outer layer 204 can be discontinuous, in that it includes a slit or a cut in order to form the overlapping and underlying portions 220, 222. In other words, a first edge 224 of the outer layer 204 is spaced apart from a second edge 225 of the outer layer 204 so as not to form a continuous layer.

[0136] As shown in FIG. 19, the sheath 8 can also include a thin layer of bonding or adhesive material 228 positioned between the inner and outer layers 202, 204. In one implementation, the adhesive material 228 can comprise a polyurethane material such as Tecoflex. The adhesive material 228 can be positioned on an inner surface 202 of at least a portion of the outer layer 204 so as to provide adhesion between selected portions of the inner and outer layers 202, 204. For example, the outer layer 204 may only include a Tecoflex layer 228 around the portion of the inner surface 230 that faces the lumen-forming portion of the inner layer 202. In other words, the Tecoflex layer 228 can be positioned so that it does not contact the folded portion 218 of the inner layer 202 in some implementations. In other implementations, the Tecoflex layer 228 can be positioned in different configurations as desired for the particular application. For example, as shown in FIG. 19, the Tecoflex layer 228 can be positioned along the entire inner surface 230 of the outer layer 204. In an alternative example, the Tecoflex layer can be applied to the outer surface of the inner layer 202 instead of the inner surface of the outer layer 204. The Tecoflex layer can be applied to all or selected portions on the inner layer 202; for example, the Tecoflex layer can be formed only on the portion of the inner layer 202 that faces the lumen-forming portion of the outer layer 204 and not on the folded portion 218. The configuration of FIG. 19 allows for radial expansion of the sheath 208 as an outwardly directed radial force is applied from within (e.g., by passing a medical device such as a prosthetic heart valve through the lumen 212). As radial force is applied, the folded portion 218 can at least partially separate, straighten, and / orunfold, and / or the overlapping portion 220 and the underlying portion 220 of the outer layer 204 can slide circumferentially with respect to one another, thereby allowing the diameter of lumen 212 to enlarge.

[0137] In this manner, the sheath 208 is configured to expand from a resting / unexpanded configuration (FIG.19) to an expanded configuration shown in FIG. 20. In the expanded configuration, as shown in FIG. 20, an annular gap 232 can form between the longitudinal edges of the overlapping portion 220 and the underlying portion 222 of the outer layer 204. As the sheath 208 expands at a particular location, the overlapping portion 220 of the outer layer 204 can move circumferentially with respect to the underlying portion 222 as the folded portion 218 of the inner layer 202 unfolds. This movement can be facilitated by the use of a low-friction material for inner layer 202, such as PTFE. Further, the folded portion 218 can at least partially separate and / or unfold to accommodate a medical device having a diameter larger than that of lumen 212 in the resting / unexpanded configuration. As shown in FIG. 20, in some implementations, the folded portion of the inner layer 108 can completely unfold, so that the inner layer 108 forms a cylindrical tube at the location of the expanded configuration.

[0138] Similar to the example sheath 8 in FIG. 14, the sheath 8 is configured to locally expands at a particular location corresponding to the location of the medical device along the length of the lumen 212, and then locally contracts once the medical device has passed that particular location. Thus, a bulge may be visible, traveling longitudinally along the length of the sheath 8 as a medical device is introduced through the sheath 8, representing continuous local expansion and contraction as the device travels the length of the sheath 8. Each segment of the sheath 8 will locally contract after removal of any radial outward force such that the sheath 8 at least partially returns to the original resting / unexpanded diameter of lumen 212. Similar to the example sheath described above, an elastic outer layer 250 can (optionally) be provided along the sheath 208, urging the inner and outer layers 202, 204 back towards the unexpanded configuration.

[0139] The layers 202, 204 of sheath 8 can be configured having the folded portion 218 as shown in FIG. 19 along at least a portion of the length of the sheath 208. In some examples, the inner and outer layers 202, 204 can be configured as shown in FIG. 19 along the length A (FIG. 15) such that the folded portion 218 extends from a location adjacent the soft tip portion 206 to a location closer to the proximal end 214 of the sheath 208, adjacent and / or under the distal end of the strain relief layer 26. In this matter, the sheath 8 is expandable andcontractable only along a portion of the length of the sheath corresponding to length A (which typically corresponds to the section of the sheath inserted into the narrowest section of the patient’s vasculature).

[0140] In some examples, the folded portion 218 extends from a location adjacent the soft tip portion 206 under the strain relief layer 26, as illustrated in FIG. 21. In this example, the folded structure of the inner layer 202 extends from the tip portion 206, under the strain relief layer 26 and along the tapered segment 248 of the strain relief layer 26.

[0141] FIGS. 22 and 23 illustrate cross-section views of the sheath 8 taken along the strain relief layer 26 at section line 22-22 in FIG. 21. In this example, the folded portion 218 of the inner layer 202 extends under the strain relief layer 26. FIG. 22 shows a cross-section of the sheath 8 in a resting / unexpanded configuration having an inner diameter Di. FIG. 23 shows a cross-section of the sheath 208 in a (partially) expanded configuration, having an inner diameter D2, where D2 is greater than Di.

[0142] As shown in FIGS. 22-23, in some examples, the overlapping portion 220 does not overlap the entire folded portion 218 of the inner layer 202, and thus a portion of the folded portion 218 can be directly adjacent to the strain relief cover 26 in locations where the strain relief cover 26 is present. In locations where the strain relief cover 26 is not present, part of the folded portion 218 may be visible from the outside of the sheath 8, as seen in FIG. 21 (and / or visible through an outer elastic layer 250 described in more detail below). In these examples, the sheath 8 can include a longitudinal seam 234 where the overlapping portion 220 terminates at the folded portion 218. In use, the sheath 8 can be positioned such that the seam 234 is posterior to the point of the sheath that is 180 degrees from the seam 234 (e.g., facing downward in the view of FIG. 21). As shown in FIG. 21, the seam 234 need not extend the entire length of the sheath 8, and end at a transition point between portions of the sheath having a folded inner layer and portions of the sheath not having a folded inner layer.

[0143] In some examples, the folded portion 218 can include a weakened portion 236, such as a longitudinal perforation, score line, and / or slit, along at least a portion of the length of the inner layer 202. The weakened portion 236 / slit allows for the two adjacent ends 238, 240 of the folded portion 218 / inner layer 202 to move relative to one another as the sheath 8 expands to the expanded configuration shown in FIG. 23. For example, the sheath 8 locally expands as a medical device is inserted therethrough, causing the weakened portion 236 to split / separate.

[0144] As illustrated in FIGS. 2, 15 and 21, the sheath 8 includes a strain relief layer 26. The strain relief layer 26 / tube is provided adjacent the proximal end of the sheath 8 extends along / over the outer surface of the sheath 8. In some examples, the strain relief layer 26 is provided over the outer layer 108, 204 of the sheath 8. The strain relief layer 26 forms a smooth transition between the sheath hub 20 and the sheath 8 and facilitates mating of the sheath 8 with the sheath hub 20.

[0145] Additionally, and as will be described in more detail below, the strain relief layer 26 provides a region of higher durometer or stiffness that restricts expansion of the underlying sheath layers. This helps to ensure hemostasis between the portions of the sheath 8 inside the patient and the sheath hub (external to the patient). The increased durometer and / or stiffness along the strain relief layer 26 prevents blood from flowing between the various layers of the sheath 8 exterior to the patient during the procedure, helping to withstand the blood pressure that would otherwise cause the sheath to “balloon up” with body fluid / blood. Additionally, the strain relief layer 26 can be sized and configured to form a seal with the patient’s artery when inserted, such that blood is substantially prevented from flowing between the strain relief layer 26 and the vessel wall. For example, although the strain relief layer 26 does not extend all the way to the distal end 210 of the sheath 8, the strain relief layer 26 can extend distally enough along the sheath 8 that when the sheath 8 is fully inserted into the patient a portion of the strain relief layer 26 extends through and seals against the arteriotomy site.

[0146] As described above, the strain relief layer 26 is provided over the outer layer 108, 204 of the sheath 8. The strain relief layer 26 can be bonded to the outer layer 108, 204 to prevent the strain relief layer 26 from sliding over the outer layer and “bunching up” in response to the friction forces applied by the surrounding tissue during insertion of the sheath 8 into the patient’s vasculature. For example, the strain relief layer 26 can be bonded at the proximal end and / or distal end of the outer layer 108, 204. At the proximal and distal ends, the strain relief layer 26 can be bonded to the outer layer 204 around the full circumference of the outer layer. At the distal end of the sheath 208, the strain relief layer 26 can alternatively be bonded to the inner layer(s) of the sheath 8. For example, the strain relief layer 26 can be bonded to the distal end surface of the inner layer 102, 202.

[0147] FIGS. 18, 22 and 23 illustrate cross-section views of the sheath 8 along the strain relief layer 26. FIG. 18 shows a cross-section of a segment of the sheath near the proximalend 214 of the sheath 8, as indicated by section line 18-18 in FIG. 15. Similarly, FIGS. 22 and 23 show cross-section segments of various example sheaths near the proximal end 214 of the sheath 8 and closer to the distal end of the strain relief layer 26, as indicated by section line 22-22 in FIG. 21. As illustrated in each of FIGS. 15-23, the sheath 8 at this location can comprise an inner layer (liner) 202, outer layer 208, adhesive layer 228, an optional elastic outer layer 250, and the strain relief layer 26.

[0148] The strain relief layer 26 extends circumferentially around at least a portion of the inner layer 202 and outer layer 204. The strain relief layer 26 extends from the proximal end 214 of the sheath 8 toward the distal end 210 of the sheath 8. As shown in FIG. 21 (and FIG. 15), the strain relief layer 26 extends for a length L along at least a portion of the main body of the sheath 8. In further examples, the strain relief layer 26 extends to a point adjacent the distal end 210, or can extend all the way to the distal end 210 of sheath 8. In some examples, the longitudinal length L of the strain relief layer 26 can range from about 10 cm to the entire length of the sheath 8.

[0149] The strain relief layer 26 extends to / adjacent the proximal end 214 of the sheath 8 and provides a compression fit over the distal end of the sheath hub 20 thereby coupling the sheath 8 to the sheath hub 20. Additionally or alternatively, the strain relief layer 26 secured between the sheath hub 20 and the sheath hub cap 22 or other fastening device for by coupling the proximal end of the sheath to the sheath hub 20. In some examples, the strain relief layer 26 does not extend all the way to the proximal end 214 of the sheath 208.

[0150] It is understood that strain relief layer 26, as shown herein, can have similar composition and characteristics of the inner and outer layers as disclosed herein. Various compositions are disclosed, for example, in Application No. PCT / US2021 / 301275, entitled “Expandable sheath for introducing an endovascular delivery device into a body,” the disclosure of which is herein incorporated by reference.

[0151] The strain relief layer 26 can comprise any lubricious, low- friction, and / or relatively non-elastic material. Preferably the materials used can include high durometer polymers, with low elasticity. In some examples, the strain relief layer 26 is composed of the same and / or similar material to the inner layer 202 and / or outer layer 204. For example, as described above regarding the inner and / or outer layer 102, 108, exemplary materials can include polyurethane (e.g., high density polyethylene), ultra-high-molecular-weight polyethylene (UHMWPE) (e.g., Dyneema®), high-molecular- weight polyethylene(HMWPE), or polyether ether ketone (PEEK). Other suitable materials for strain relief layer 26 can include polyimide, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyamide, polyether block amide (e.g., Pebax), and / or combinations of any of the above. Materials for the strain relief layer 26 can be selected such that it impedes expansion of the underlying layers of the sheath 8.

[0152] The strain relief layer 26 can have a thickness ranging from, for example, about 0.001” to about 0.010.” In some implementations, the strain relief layer 26 can have a thickness of from about 0.003” to about 0.006.” The wall thickness is measured radially between the inner surface of the strain relief layer 26 and the outer surface of the strain relief layer 26.

[0153] In alternative examples, the material composition and / or wall thickness can change along the length of the strain relief layer 26. For example, the strain relief layer 26 can be provided with one or more segments, where the composition and / or thickness changes from segment to segment. In an example implementation, the Durometer rating of the composition changes along the length of the strain relief layer 26 such that segments near the proximal end comprise a stiffer material or combination of materials, while segments near the distal end comprise a softer material or combination of materials. Similarly, the wall thickness of the strain relief layer 26 in segments near the proximal end can be thicker / greater than the wall thickness of the outer layer 250 near the distal end.

[0154] As illustrated in FIGS. 15 and 21, the strain relief layer 26 has a proximal end and a distal end and a central lumen extending longitudinally therethrough. The strain relief layer 26 includes a generally tubular shaped proximal portion 242 adjacent the proximal end of the strain relief layer 26, and a generally tubular shaped distal portion 246 adjacent the distal end of the strain relief layer 26. The strain relief layer 26 includes a frustoconical shaped tapered segment 248 extending between the proximal portion 242 and the distal portion 246 of the strain relief layer 26, such that the diameter of the strain relief layer 26 at the proximal portion 242 is greater than the diameter of the strain relief layer 26 at the distal portion 246 of the strain relief layer 26. The tapered segment 248 and the flared proximal portion 242 help ease the transition of the medical device / delivery system when passing between the larger diameter sheath hub 20 to the smaller diameter of the sheath 8.

[0155] As described above, the strain relief layer 26 is made of a material that is stiffer than the other sheath 8 layers such that the strain relief layer 26 inhibits expansion of the portion of the sheath disposed along / under the strain relief layer 26. Because radial expansion is limited along the strain relief layer 26, higher push forces are necessary to advance the medical device 12 through the central lumen of the sheath 8. In some examples, the highest push force through the sheath 8 are experienced near the ends (e.g., proximal and distal ends) of the strain relief layer 26. The thickness and / or composition of the strain relief layer 26 can be adjusted to improve the performance of the strain relief layer 26 and to reduce the push force.

[0156] The elastic outer layer 250 can be positioned around at least a portion of the strain relief layer 26, outer layer 108, 204 and / or the inner layers of the sheath 8. As illustrated in FIGS. 21-23, the outer layer 250 can surround the entire circumference of outer layer 204, and can extend longitudinally along any portion of the length of the sheath 8, including along (over or under) the strain relief layer 26. The elastic outer layer 250 extends for a length along at least a portion of the main body of the sheath 8. In some examples, the elastic outer layer 250 extends to a point adjacent the distal end 210, or can extend all the way to the distal end 210 of sheath 8. For example, the elastic outer layer 250 extends over the entire length of the sheath 8.

[0157] As shown in FIGS. 17-20, 22 and 23, the elastic outer layer 250 can be a continuous tubular layer, without slits or other discontinuities. The elastic outer layer 250 extends between strain relief layer 26 and the outer surface of the outer layer 204. In other examples, the elastic outer layer 250 extends over the outer surface of the strain relief layer 26 and the outer surface outer layer 204. In further examples, the elastic outer layer 250 extends both over the strain relief layer 26 and / or between the outer layer of the sheath 8 and the strain relief layer 26.

[0158] The elastic outer layer 250 can comprise any pliable, elastic material(s) that expand and contract, preferably with a high expansion ratio. Preferably, the materials used can include low durometer polymers with high elasticity, such as Pebax, polyurethane, silicone, and / or polyisoprene. Materials for the elastic outer layer 250 can be selected such that it does not impede expansion of the inner and outer layers of the sheath 8. The elastic outer layer 250 can have a thickness ranging from, for example, about 0.001” to about 0.010.” In some implementations, the elastic outer layer 250 can have a thickness of from about 0.003” toabout 0.006.” The elastic outer layer 250 can be configured to stretch and expand as the sheath expands, as shown in the expanded configuration in FIG. 20.

[0159] A method of delivering a medical device through a sheath (e.g., to a procedure site) is described below. When used to deliver a medical device to a treatment site within a patient, the sheath 8 is inserted at least partially into the blood vessel of the patient and the distal end of the sheath 8 is positioned at a location proximate the treatment site. A tapered introducer 6 can be positioned within sheath 8 to facilitate insertion into the treatment site.

[0160] In this example, the sheath 8 is coupled to the introducer 6 such that axial movement between the introducer 6 and the sheath 8 is eliminated. Preventing movement and gapping between the introducer 6 and the sheath 8 during insertion reduces the risk of trauma to the patient’s vasculature. FIG. 2 shows the example device for delivering the prosthetic device.

[0161] The method includes providing an introducer hub 30 having an elongated introducer 6 coupled to the hub body 32 of the introducer hub 30. As described above, the introducer hub 30 includes a locking channel 38 disposed in the hub body 32. The sheath locking sleeve 28 is advanced to a position adjacent a distal end of the introducer hub 30 such that a guide 31 projecting from an outer surface of the sheath locking sleeve 28 is received within the opening to the locking channel 38. Advancing the sheath locking sleeve 28 to a position adjacent the distal end of the introducer hub 30 also includes advancing the introducer 6 axially within the central lumen of the expandable sheath 8.

[0162] The introducer hub 30 is then rotated in a first direction with respect to the locking sleeve 28 to move the guide 31 along the locking channel 38 into a locked position. In particular, moving the guide 31 into the locked position includes rotating the introducer hub 30 to move the guide 31 along a guide portion 40 of the locking channel 38 toward a locking portion 42. Further rotation of the introducer hub 30 directs the guide 31 into the locking portion 42 of the locking channel 38, the locking portion 42 configured to securely engage the guide 31 and fix the axial position of the introducer hub 30 with respect to the sheath locking sleeve 28. Where the locking channel 38 includes a catch 44, rotation of the introducer hub 30 in the first direction causes the guide 31 to overcome the bias force of the catch 44 and advance the guide 31 beyond the catch 44 into the locking portion 42, where the catch 44 secures the guide 31 within the locking portion 42 thereby fixing the axial location of the sheath 8 with respect to the introducer 6.

[0163] The coupled sheath 8 and introducer 6 are then inserted, at least partially, into the vasculature of the patient and the distal end of the sheath 8 is positioned at a location proximate the treatment site.

[0164] Once positioned, the introducer hub 30 is rotated in a second, opposite, direction with respect to the locking sleeve 28. Rotating the introducer hub 30 in the second direction causes the guide 31 to slide along the locking channel 38, from the locking portion 42 toward the guide portion 40. In particular, rotating of the introducer hub 30 in the second direction directs the guide 31 out of the locking portion 42 of the locking channel 38 and through the guide portion 40 and releases the introducer hub 30 from the sheath locking sleeve 28. Where the locking channel 38 includes a catch 44, rotation of the introducer hub 30 in the second direction causes the guide 31 to overcome the bias force of the catch 44 and advance from the locking portion 42 to the guide portion 40 of the locking channel 38. As a result, the guide 31 slides out of the locking channel 38 into the unlocked position.

[0165] The introducer hub 30 is then disengaged from the locking sleeve 28 and the introducer 6 is withdrawn from the central lumen of the sheath 8. With the central lumen of the sheath 8 clear, the prosthetic device 12 (e.g., implant 12) is advanced through the central lumen of the sheath 8. As described above, the prosthetic device 12 (implant 12) is delivered to the procedure site via the central lumen of the sheath 8.

[0166] A method of securing a delivery sheath to an introducer in a device for prosthetic heart valve delivery device is disclosed herein. The method comprises providing an introducer hub 30 having an elongated introducer 6 coupled thereto and including a locking channel 38 disposed in the hub body 32. The sheath locking sleeve 28 is advanced to a position adjacent a distal end of the introducer hub 30 such that a guide 31 projecting from an outer surface of the sheath locking sleeve 28 is received within an opening of the locking channel 38. Advancing the sheath locking sleeve 28 to a position adjacent the distal end of the introducer hub 30 also includes advancing the introducer 6 axially within the central lumen of the expandable sheath 8.

[0167] The introducer hub 30 is then rotated in a first direction with respect to the locking sleeve 28 to move the guide 31 along the locking channel 38 into the locked position. In particular, moving the guide 31 into the locked position includes rotating the introducer hub 30 to move the guide 31 along a guide portion 40 of the locking channel 38 toward a locking portion 42. Further rotation of the introducer hub 30 directs the guide 31 into the lockingportion 42 of the locking channel 38, the locking portion 42 configured to securely engage the guide 31 and fix the axial position of the introducer hub 30 with respect to the sheath locking sleeve 28. Where the locking channel 38 includes a catch 44, rotation of the introducer hub 30 in the first direction causes the guide 31 to overcome the bias force of the catch 44 and advance the guide 31 beyond the catch 44 into the locking portion 42, where the catch 44 secures the guide 31 within the locking portion 42 thereby fixing the axial location of the sheath 8 with respect to the introducer 6.

[0168] To unlock the introducer hub 30 from the locking sleeve 28, the introducer hub 30 is rotated in a second, opposite, direction with respect to the locking sleeve 28. Rotating the introducer hub 30 in the second direction causes the guide 31 to side along the locking channel 38, from the locking portion 42 toward the guide portion 40. In particular, rotating of the introducer hub 30 in the second direction directs the guide 1 out of the locking portion 42 of the locking channel 38 and through the guide portion 40 to release the introducer hub 30 from the sheath locking sleeve 28. Where the locking channel 38 includes a catch 44, rotation of the introducer hub 30 in the second direction causes the guide 31 to overcome the bias force of the catch 44 and advance from the locking portion 42 to the guide portion 40 of the locking channel 38. As a result, the guide 31 slides out of the locking channel 38 into the unlocked position. The introducer hub 30 is then disengaged from the locking sleeve 28 and the introducer 6 can be withdrawn from the central lumen of the sheath 8.

[0169] The devices depicted in FIGS. 25-29B are used to stabilize a sheath, for example, when a length of the sheath 8 would otherwise extend outside of a patient. Such methods can be helpful when utilizing alternatives to the femoral approach, such as, but not limited to, the carotid, subclavian, and axillary approaches as shown in FIG. 24. FIG. 24 shows sheaths introduced at the femoral access site Sf , the carotid access site Sc. the axillary access site Sa, and the subclavian access site Ss. The methods disclosed herein can also be useful when treating a child or a smaller adult, or in a veterinary setting, where a provided sheath 8 is longer than necessary and would otherwise dangle outside the patient’s body. The methods include positioning one or more of the sheath hub 340, the hub cap 320, and / or the sheath 8 within the central space 486 of the stabilizer housing 480. The stabilizer housing 480 is moved from an unlocked position to a locked position, thereby coupling the sheath hub 340, hub cap 320, and / or the sheath 8 to the stabilizer housing 480. A first end 512 of the positioning arm 510 is coupled to a static platform 520, such as, but not limited to, a cathlabtable or a hospital bed, or a movable platform that can is positioned underneath the patient prior to the procedure. A second end 514 of the positioning arm 510 is coupled to the stabilizer housing 480 (if second end second end 514 is not a unitary structure with stabilizer housing 480). The positioning arm 510 can be moved and fixed in place to stabilize the position of the proximal end 314 of sheath 8 for the procedure.

[0170] Sheath 8 can be stabilized before or after insertion into the incision site of the patient. Once sheath 8 is fixed in place within an incision site of the patient, a medical device 12 can be moved through sheath hub 340 and central space 486 of the sheath stabilizer, through central lumen 312 of sheath 8, and beyond the distal end 310 of sheath 8.

[0171] Furthermore, while the methods described in reference to FIGS. 25-29B discuss a stabilizer housing 480 used with a sheath hub 340 that includes a hub cap 320, it should be understood that the methods of using a sheath stabilizer may be modified for sheath hubs that do not include a hub cap 320.

[0172] Referring to the implementation depicted in FIGS. 27 and 28, the sheath stabilizer housing 480 is moved to the locked position by moving the first shell body 488 of the stabilizer housing 480 toward the second shell body 494 of the stabilizer housing 480. This can include closing the hinged coupling 522 formed between the first shell body 488 and the second shell body 494, thereby moving a second longitudinal edge 492 of the first shell body 488 toward a second longitudinal edge 498 of the second shell body 494. Some methods can further include engaging complementary fastening features disposed on the second longitudinal edge 492 of the first shell body 488 and the second longitudinal edge 498 of the second shell body 494 (such as, but not limited to, tab 506 and socket 507). Some methods include resisting axial movement of sheath hub 340, hub cap 320, and / or sheath 8 when stabilizer housing 480 is in the locked position. This can include abutting hub cap 320 distal end 326 against a shelf 582 of the stabilizer housing 480 formed along an inner surface near the distal end 484 of the stabilizer housing 480. The stabilizer housing 480 can be coupled to second end 514 of positioning arm 510 by receiving the positioning arm 510 within the positioning arm opening 502 defined by the stabilizer housing 480. For example, locking nut 516 of the positioning arm 510 can be received within a recess 504 defined by the positioning arm opening 502. In some implementations, positioning arm 510 can be transitioned between a locked configuration and an unlocked configuration, for example, by activating or deactivating a locking mechanism (which can, in some implementations, include lockingbutton 604). This transition of the positioning arm between a locked and unlocked configuration allows for adjustments of the positioning arm 510 during the procedure (such that sheath 8 and stabilizer housing 480 move with positioning arm 510).

[0173] Referring to the implementation depicted in FIGS. 29A and 29B, the sheath hub 340, hub cap 320, and / or sheath 8 can be positioned within central space 486 of the stabilizer housing 480 by pressing them into central space 486. In some implementations, this may be achieved by a snap- fit or press-fit engagement (i.e., by snapping the sheath hub 340, the hub cap 320, or both into place within the stabilizer housing 480). Alternatively, or in addition, a return latch 602 or other fastener can be utilized to position sheath hub 340 and / or hub cap 320 into central space 486. For example, the methods can include retracting a return latch 602 against the bias to move the stabilizer housing 480 to the unlocked position, and then releasing the return latch 602 moves the stabilizer housing 480 to a locked position. In the locked position, the return latch 602 presses the sheath hub 340, the hub cap 320, or both against the stabilizer housing 480.

[0174] In this example, a medical device and / or delivery system for a medical device is introduced into the proximal end of the central lumen of the expandable sheath 8. As provided in the example sheath 8 described above in reference to FIGS. 11-23, the sheath 8 includes a continuous inner layer (e.g., inner layers 102, 104, 106, 202) defining the central lumen extending through the sheath 8, an outer layer (e.g., fourth layer 108, outer layer 204) provided over the inner layer, and a tubular strain relief layer 26 provided over the outer layer of the sheath 8. The strain relief layer 26 is provided at the proximal end of the sheath 8 and extends along a least a portion of the length of the sheath 8.

[0175] The medical device / delivery system is advanced through a portion of the sheath 8 corresponding to the strain relief layer 26. The medical device is then advanced beyond the distal end of the strain relief layer 26 and into the lumen of the longitudinally body portion of the sheath 8 beyond the strain relief layer 26. As the medical device / delivery system is advanced through the sheath 8 (beyond the strain relief layer 26), the sheath 8 locally expands from the unexpanded configuration (FIGS. 11- 13 A, 17-19) to the expanded configuration (FIGS. 14, 20) at a location proximate the medical device in response to the outwardly directed radially force of the medical device exerted against the inner layer / central lumen of the sheath 8.

[0176] As the medical device / delivery system passes through the lumen of the sheath 8, the sheath 8 locally contracts at least partially back to the unexpanded configuration (FIGS. 11-13 A, 17-19). When used to deliver a medical device to a treatment site within a patient, the medical device is then passed through the distal tip 9 / distal opening of the sheath 8 and delivered to the treatment site. The position of the medical device can be moved or adjusted until the medical device is adequately positioned within the patient. With the medical device delivered to the treatment site, any delivery system / components coupled to the medical device are then removed from the medical device and withdrawn from the lumen of the sheath 8. The sheath 8 is removed from the patient and the opening in the blood vessel and skin closed.

[0177] In some examples, at least one of the inner layer and / or outer layer includes at least one folded portion, e.g., ridges 126 and valleys 128 of the fourth (outer) layer 108 of the sheath 8 illustrated in FIGS. 11-14, and folded portion 218 of the inner layer 202 of the sheath 8 illustrated in FIGS. 15-23. Locally expanding the lumen of the sheath 8 causes a length of the folded portion to at least partially unfold. Similarly, locally contracting the sheath 8 at least partially back to the unexpanded configuration causes a length of the folded portion to urge back towards a folded configuration.

[0178] In some examples, the outer layer is a discontinuous outer layer and includes an overlapping portion (e.g., overlapping portion 220) and an underlying portion (e.g., underlying portion 220). When the sheath 8 is in the unexpanded configuration, the overlapping portion overlaps the underlying portion with the folded portion of the inner layer disposed between the overlapping portion and the underlying portion (FIGS. 17, 19, 22, 23). As the sheath 8 locally expands to / toward the expanded configuration, a length of the overlapping portion moves circumferentially with respect to the underlying portion unfolding. As illustrated in FIG. 20, when the sheath 8 is fully expanded, the inner layer extends into the gap 232 formed between the longitudinal edges of the overlapping portion 220 and the underlying portion 222 of the outer layer 204.

[0179] In some examples, the sheath 8 includes an elastic outer layer 250 that extends at least partially over the outer layer and / or the strain relief layer 26. The elastic outer layer 250 locally expands and contracts as the medical device is advanced through the lumen of the sheath 8. In some examples, the elastic outer layer 250 urges the various layers of the sheath 8 toward an unexpanded configuration.

[0180] The medical device described above can include a prosthetic device mounted in a radially crimped state on a delivery apparatus, and the act of advancing the prosthetic device through the lumen of the sheath 8 comprises advancing the delivery apparatus and the prosthetic device through lumen of the sheath 8 and into the 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. As described above, the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the sheath 8.

[0181] Exemplary Aspects

[0182] 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.

[0183] Example 1. A stabilizer system for use in a medical procedure to stabilize an access sheath or delivery device, the stabilizer system comprising: a stabilizer housing configured to interface with an access sheath and / or a delivery device, the stabilizer housing having a locked position and an unlocked position, the stabilizer housing extending between a stabilizer proximal end and a stabilizer distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or delivery device; wherein, in the locked position, the stabilizer housing couples directly to and extends at least partially around a portion of an access sheath and / or a delivery device fixing the position of the portion with respect to the stabilizer housing. .

[0184] Example 2. The system according to any example herein, particularly example 1 further comprising: a sheath hub for an access sheath and / or delivery device comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; a hub cap coupled to the hub distal end of the sheath hub, the hub cap comprising a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough; a sheath coupled to the sheath hub via the hub cap, a portion of the sheath positioned between the sheath hub and the hub cap, the sheath comprising a sheath distal end, a sheath proximal end and a central lumen extendingtherethrough, wherein, when the stabilizer housing is in the locked position, the stabilizer housing couples directly to and extends around a portion of the sheath hub, the hub cap, and / or the sheath, wherein in the locked position, a return latch of the stabilizer housing presses the sheath hub against the stabilizer housing.

[0185] Example 3. The system according to any example herein, particularly example 2, wherein the return latch comprises a neutral position and a retracted position, and where the return latch is bias toward the neutral position.

[0186] Example 4. The system according to any example herein, particularly examples 1-3, wherein in the neutral position the return latch extends at least partially into the central space, and slidable movement toward the retracted position moves the return latch away from the central space.

[0187] Example 5. The system according to any example herein, particularly examples 1-4, wherein in the locked position, the stabilizer housing is sized and configured to provide a complementary snap fit with the sheath hub, the hub cap, or both.

[0188] Example 6. The system according to any example herein, particularly examples 1-5, wherein the stabilizer housing comprises a first shell body comprising a first longitudinal edge and a second longitudinal edge and a second shell body comprising a first longitudinal edge and a second longitudinal edge, wherein the first longitudinal edge of the first shell body is coupled to the first longitudinal edge of the second shell body, and wherein the stabilizer housing is movable between the unlocked position, in which the second longitudinal edge of the first shell body and the second longitudinal edge of the second shell body are spaced apart, and the locked position, in which the second longitudinal edge of the first shell body engages the second longitudinal edge of the second shell body.

[0189] Example 7. The system according to any example herein, particularly example 6, wherein the first shell body extends circumferentially between the first longitudinal edge and the second longitudinal edge to form a partially cylindrical first shell body, and the second shell body extends circumferentially between the first longitudinal edge and the second longitudinal edge to form a partially cylindrical second shell body.

[0190] Example 8. The system according to any example herein, particularly examples 6- 7, wherein in the locked position the first shell body and the second shell body close such that the stabilizer housing takes a generally cylindrical form.

[0191] Example 9. The system according to any example herein, particularly examples 6- 8, wherein the first longitudinal edge of the first shell body and the first longitudinal edge of the second shell body are hingedly coupled to each other.

[0192] Example 10. The system according to any example herein, particularly examples 6-9, wherein the second longitudinal edge of the first shell body and the second longitudinal edge of the second shell body comprise complementary fastening features.

[0193] Example 11. The system according to any example herein, particularly examples 6-10, wherein a locked position diameter of the central space at the distal end of the stabilizer housing corresponds to a diameter at or near the proximal end of the sheath.

[0194] Example 12. The system according to any example herein, particularly examples 6-11, wherein a locked position diameter of the central space at the proximal end of the stabilizer housing corresponds to a diameter of the sheath hub.

[0195] Example 13. The system according to any example herein, particularly examples 6-12, wherein an inner surface near the distal end of the stabilizer housing comprises a shelf sized and configured to abut the hub cap distal end to prevent the hub cap and the sheath from moving distally when the stabilizer housing is in the locked position.

[0196] Example 14. The system according to any example herein, particularly examples 1-13, further comprising an articulating positioning arm, wherein the positioning arm is attachable to a static platform at a first end and to the stabilizer housing at a second end.

[0197] Example 15. The system according to any example herein, particularly example 14, wherein the positioning arm comprises a locked configuration, an unlocked configuration and a locking mechanism configured to transition the positioning arm between the locked configuration and the unlocked configuration.

[0198] Example 16. The system according to any example herein, particularly examples 14-15, wherein the stabilizer housing comprises a first shell body and a second shell body, wherein at least one of the first shell body and the second shell body defines a positioning arm opening at the proximal end of the stabilizer housing configured to couple with the second end of the positioning arm.

[0199] Example 17. The system according to any example herein, particularly examples 1-16, further comprising a positioning arm, the positioning arm having a first end that is attachable to a static platform and a second end that is a unitary component with the stabilizer housing.

[0200] Example 18. The system according to any example herein, particularly examples 1-17, wherein the stabilizer housing defines a port opening sized and configured to receive a port extending from the sheath hub.

[0201] Example 19. A method of stabilizing an access sheath or delivery device, the method comprising: handling a stabilizer housing configured to interface with an access sheath and / or medical device, the stabilizer housing having an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or a delivery device; handling a sheath hub for an access sheath and / or a delivery device comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; positioning one or more of the sheath hub, a hub cap coupled to the sheath hub, and the sheath within the central space of the stabilizer housing at a location having a size and shape corresponding to the outer surface sheath hub, hub cap and / or sheath; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; and fixing a position of the stabilizer housing with respect to the sheath hub, hub cap, and / or sheath.

[0202] Example 20. The method according to any example herein, particularly example19, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises moving a first shell body of the stabilizer housing toward a second shell body of the stabilizer housing.

[0203] Example 21. The method according to any example herein, particularly example20, wherein moving the first shell body toward the second shell body comprises closing a hinged coupling formed between a first longitudinal edge of the first shell body and a first longitudinal edge of the second shell body, thereby moving a second longitudinal edge of the first shell body toward a second longitudinal edge of the second shell body.

[0204] Example 22. The method according to any example herein, particularly examples 20-21, further comprising engaging complementary fastening features disposed on the second longitudinal edge of the first shell body and the second longitudinal edge of the second shell body.

[0205] Example 23. The method according to any example herein, particularly examples 19-22, wherein the a hub cap is coupled to the hub distal end, the hub cap comprising a hubcap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough, and a proximal end of a sheath is disposed between the hub cap distal end and the hub distal end such that coupling the hub cap to the sheath hub fixes the sheath to the sheath hub; the method further comprising: abutting the hub cap distal end against a shelf of the stabilizer housing formed along an inner surface near the distal end, thereby resisting axial movement of the sheath hub, the hub cap, and the sheath when the stabilizer housing is in the locked position.

[0206] Example 24. The method according to any example herein, particularly example 23, wherein positioning the sheath hub, the hub cap, and the sheath within the central space of the stabilizer housing further comprises pressing the sheath hub, the hub cap, or both into a central space.

[0207] Example 25. The method according to any example herein, particularly examples 19-24, wherein retracting a return latch against a bias moves the stabilizer housing to the unlocked position, and releasing the return latch moves the stabilizer housing to a locked position.

[0208] Example 26. The method according to any example herein, particularly example 25, wherein in the locked position the return latch presses the sheath hub, the hub cap, or both against the stabilizer housing.

[0209] Example 27. The method according to any example herein, particularly examples 19-26, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises snapping the sheath hub, the hub cap, or both into place within the stabilizer housing.

[0210] Example 28. The method according to any example herein, particularly examples 19-27, further comprising coupling a first end of a positioning arm to a static platform, wherein a second end of the positioning arm is coupled to the stabilizer housing.

[0211] Example 29. The method according to any example herein, particularly example 28, further comprising coupling the stabilizer housing with the second end of the positioning arm by receiving the second end of the positioning arm within a positioning arm opening defined by at least one of a first shell body of the stabilizer housing and a second shell body of the stabilizer housing.

[0212] Example 30. The method according to any example herein, particularly examples 28-29, further comprising transitioning the positioning arm between a locked configuration and an unlocked configuration.

[0213] Example 31. The method according to any example herein, particularly examples 19-30, wherein fixing the position of the stabilizer housing fixes a position of a proximal end of the sheath.

[0214] Example 32. A method of delivering a medical device through a sheath, the method comprising: handling a stabilizer housing comprising an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space; handling a sheath hub comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; coupling a hub cap to the hub distal end, the hub cap comprising a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough; disposing a proximal end of a sheath between the hub cap distal end and the hub distal end such that coupling the hub cap to the sheath hub fixes the sheath to the sheath hub; positioning the sheath hub, the hub cap, and the sheath within the central space of the stabilizer housing; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; inserting the sheath into an incision site of a patient; and fixing a position of the stabilizer housing, thereby fixing a location of a proximal end of the sheath.

[0215] Example 33. The method according to any example herein, particularly example 32, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises moving a first shell body of the stabilizer housing toward a second shell body of the stabilizer housing.

[0216] Example 34. The method according to any example herein, particularly examples 32-33, further comprising aligning the central space of the stabilizer housing, the hub lumen of the sheath hub, and the central lumen of the sheath to facilitate passage of a medical device therethrough.

[0217] Example 35. The method according to any example herein, particularly examples 32-34, wherein positioning the sheath hub, hub cap, and sheath within the central space of the stabilizer housing further comprises pressing the sheath hub, the hub cap, or both into a central space.

[0218] Example 36. The method according to any example herein, particularly examples 32-35, wherein retracting a return latch against a bias moves the stabilizer housing to the unlocked position, and releasing the return latch moves the stabilizer housing to a locked position.

[0219] Example 37. The method according to any example herein, particularly example 36, wherein in the locked position the return latch presses the sheath hub, the hub cap, or both against the stabilizer housing.

[0220] Example 38. The method according to any example herein, particularly examples 32-37, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises snapping the sheath hub, the hub cap, or both into place within the stabilizer housing.

[0221] Example 39. The method of any one of clauses 32-38, further comprising moving a medical device past the central space of the stabilizer housing.

[0222] Example 40. The method according to any example herein, particularly example 39, further comprising advancing the medical device through the central lumen of the sheath.

[0223] Example 41. The method according to any example herein, particularly examples 39-40, further comprising advancing the medical device beyond a distal opening of the sheath to a treatment site.

[0224] Example 42. The method according to any example herein, particularly examples 39-41, wherein the medical device is a prosthetic heart valve mounted in a radially crimped state on a delivery apparatus.

[0225] Example 43. The method according to any example herein, particularly example 42, wherein the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.

[0226] Example 44. The method according to any example herein, particularly examples 42-43, wherein the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the sheath.

[0227] Example 45. The method according to any example herein, particularly examples 32-44, further comprising coupling a first end of a positioning arm to a static platform, wherein a second end of the positioning arm is coupled to the stabilizer housing.

[0228] Example 46. The method according to any example herein, particularly example 45, further comprising transitioning the positioning arm between a locked configuration and an unlocked configuration and adjusting the position of the positioning arm.

[0229] In view of the many possible implementations 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.

[0230] The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The implementation was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various implementations with various modifications as are suited to the particular use contemplated.

Claims

WHAT IS CLAIMED IS:

1. A stabilizer system for use in a medical procedure to stabilize an access sheath or delivery device, the stabilizer system comprising: a stabilizer housing configured to interface with an access sheath and / or a delivery device, the stabilizer housing having a locked position and an unlocked position, the stabilizer housing extending between a stabilizer proximal end and a stabilizer distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or delivery device; wherein, in the locked position, the stabilizer housing couples directly to and extends at least partially around a portion of an access sheath and / or a delivery device fixing the position of the portion with respect to the stabilizer housing.

2. The system of claim 1 further comprising: a sheath hub for an access sheath and / or delivery device comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; a hub cap coupled to the hub distal end of the sheath hub, the hub cap comprising a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough; a sheath coupled to the sheath hub via the hub cap, a portion of the sheath positioned between the sheath hub and the hub cap, the sheath comprising a sheath distal end, a sheath proximal end and a central lumen extending therethrough, wherein, when the stabilizer housing is in the locked position, the stabilizer housing couples directly to and extends around a portion of the sheath hub, the hub cap, and / or the sheath, wherein in the locked position, a return latch of the stabilizer housing presses the sheath hub against the stabilizer housing.

3. The system of claim 2, wherein the return latch comprises a neutral position and a retracted position, and where the return latch is bias toward the neutral position,wherein in the neutral position the return latch extends at least partially into the central space, and slidable movement toward the retracted position moves the return latch away from the central space.

4. The system of any one of claims 2-3, wherein in the locked position, the stabilizer housing is sized and configured to provide a complementary snap fit with the sheath hub, the hub cap, or both.

5. The system of any one of claims 1-4, wherein the stabilizer housing comprises a first shell body comprising a first longitudinal edge and a second longitudinal edge and a second shell body comprising a first longitudinal edge and a second longitudinal edge, wherein the first longitudinal edge of the first shell body is coupled to the first longitudinal edge of the second shell body, and wherein the stabilizer housing is movable between the unlocked position, in which the second longitudinal edge of the first shell body and the second longitudinal edge of the second shell body are spaced apart, and the locked position, in which the second longitudinal edge of the first shell body engages the second longitudinal edge of the second shell body.

6. The system of claim 5, wherein the first shell body extends circumferentially between the first longitudinal edge and the second longitudinal edge to form a partially cylindrical first shell body, and the second shell body extends circumferentially between the first longitudinal edge and the second longitudinal edge to form a partially cylindrical second shell body, wherein in the locked position the first shell body and the second shell body close such that the stabilizer housing takes a generally cylindrical form.

7. The system of any one of claims 5-6, wherein a locked position diameter of the central space at the distal end of the stabilizer housing corresponds to a diameter at or near the proximal end of the sheath.

8. The system of any one of claims 5-7, wherein a locked position diameter of the central space at the proximal end of the stabilizer housing corresponds to a diameter of the sheath hub.

9. The system of any one of claims 5-8, wherein an inner surface near the distal end of the stabilizer housing comprises a shelf sized and configured to abut the hub cap distal end to prevent the hub cap and the sheath from moving distally when the stabilizer housing is in the locked position.

10. The system of any one of claims 1-9, further comprising an articulating positioning arm, wherein the positioning arm is attachable to a static platform at a first end and to the stabilizer housing at a second end, wherein the positioning arm comprises a locked configuration, an unlocked configuration and a locking mechanism configured to transition the positioning arm between the locked configuration and the unlocked configuration.

11. The system of claim 10, wherein the stabilizer housing comprises a first shell body and a second shell body, wherein at least one of the first shell body and the second shell body defines a positioning arm opening at the proximal end of the stabilizer housing configured to couple with the second end of the positioning arm, wherein the positioning arm having a first end that is attached to a static platform.

12. A method of stabilizing an access sheath or delivery device, the method comprising: handling a stabilizer housing configured to interface with an access sheath and / or medical device, the stabilizer housing having an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space having a size and shape corresponding to an outer surface of at least a portion of an access sheath and / or a delivery device; handling a sheath hub for an access sheath and / or a delivery device comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough;positioning one or more of the sheath hub, a hub cap coupled to the sheath hub, and the sheath within the central space of the stabilizer housing at a location having a size and shape corresponding to the outer surface sheath hub, hub cap and / or sheath; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; and fixing a position of the stabilizer housing with respect to the sheath hub, hub cap, and / or sheath.

13. The method of claim 12, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises moving a first shell body of the stabilizer housing toward a second shell body of the stabilizer housing, further comprising engaging complementary fastening features disposed on a second longitudinal edge of the first shell body and a second longitudinal edge of the second shell body.

14. The method of claim 13, wherein moving the first shell body toward the second shell body comprises closing a hinged coupling formed between a first longitudinal edge of the first shell body and a first longitudinal edge of the second shell body, thereby moving the second longitudinal edge of the first shell body toward the second longitudinal edge of the second shell body.

15. The method of any one of claims 12-14, wherein the a hub cap is coupled to the hub distal end, the hub cap comprising a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough, and a proximal end of a sheath is disposed between the hub cap distal end and the hub distal end such that coupling the hub cap to the sheath hub fixes the sheath to the sheath hub; the method further comprising: abutting the hub cap distal end against a shelf of the stabilizer housing formed along an inner surface near the distal end, thereby resisting axial movement of the sheath hub, the hub cap, and the sheath when the stabilizer housing is in the locked position.

16. The method of claim 15, wherein positioning the sheath hub, the hub cap, and the sheath within the central space of the stabilizer housing further comprises pressing the sheath hub, the hub cap, or both into a central space.

17. The method of any one of claims 12-16, wherein retracting a return latch against a bias moves the stabilizer housing to the unlocked position, and releasing the return latch moves the stabilizer housing to a locked position, wherein in the locked position the return latch presses the sheath hub, the hub cap, or both against the stabilizer housing.

18. The method of any one of claims 12-17, wherein moving the stabilizer housing from the unlocked position to the locked position further comprises snapping the sheath hub, the hub cap, or both into place within the stabilizer housing.

19. The method of any one of claims 12-18, further comprising coupling a first end of a positioning arm to a static platform, wherein a second end of the positioning arm is coupled to the stabilizer housing.

20. The method of claim 19, further comprising coupling the stabilizer housing with the second end of the positioning arm by receiving the second end of the positioning arm within a positioning arm opening defined by at least one of a first shell body of the stabilizer housing and a second shell body of the stabilizer housing.

21. The method of any one of claims 12-20, wherein fixing the position of the stabilizer housing fixes a position of a proximal end of the sheath.

22. A method of delivering a medical device through a sheath, the method comprising: handling a stabilizer housing comprising an unlocked position and a locked position, the stabilizer housing extending between a proximal end and a distal end and defining a central space;handling a sheath hub comprising a hub proximal end and a hub distal end and defining a hub lumen extending longitudinally therethrough; coupling a hub cap to the hub distal end, the hub cap comprising a hub cap proximal end and a hub cap distal end and defining a hub cap lumen extending longitudinally therethrough; disposing a proximal end of a sheath between the hub cap distal end and the hub distal end such that coupling the hub cap to the sheath hub fixes the sheath to the sheath hub; positioning the sheath hub, the hub cap, and the sheath within the central space of the stabilizer housing; moving the stabilizer housing from the unlocked position to the locked position, thereby coupling the sheath hub, the hub cap, and the sheath with the stabilizer housing; inserting the sheath into an incision site of a patient; and fixing a position of the stabilizer housing, thereby fixing a location of a proximal end of the sheath.

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