DELIVERY APPARATUS AND METHODS FOR IMPLANTING PROSTHETIC DEVICES

A delivery apparatus for delivering a prosthetic implant includes a handle body, an outer shaft, and an inner shaft. The handle body includes a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The outer shaft includes a proximal end movably coupled to the handle body. The inner shaft extends through a lumen of the outer shaft and is fixed relative to the handle body. The inner shaft includes a first reinforcement layer and a second reinforcement layer. The first reinforcement layer extends from a proximal end portion of the inner shaft to a first distal location of the inner shaft. The second reinforcement layer extends from the proximal end portion of the inner shaft to a second distal location of the inner shaft, and the second distal location is proximal to the first distal location.

FIELD

The present disclosure relates generally to delivery apparatus and methods for implanting prosthetic devices and more particularly to delivery apparatus and method for implanting support structures and/or prosthetic heart valves.

BACKGROUND

The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

In one specific example, a prosthetic valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation location in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

In some cases, it may not be possible to secure the prosthetic valve to the native valve annulus, for example, if the native valve annulus is too large or if the geometry of the native valve is too complex to allow secure implantation of the valve. One approach in these cases is to first deploy a docking station at the implantation location and then install the prosthetic valve in the docking station. The docking station can be selected to provide the necessary interface to anchor the prosthetic valve within the native valve annulus. Desirably, the docking station can be delivered to the implantation location with a minimally invasive procedure, which would allow the docking station to be deployed within the same procedure used to deliver the prosthetic valve.

SUMMARY

Disclosed herein are examples of a delivery apparatus that can be used to deliver a prosthetic implant, such as a docking station, to an implantation location within a patient's body.

A docking station can include a frame (which can also be called a “stent” or a “prestent”) comprising a plurality of struts. The struts can be interconnected in a manner that allows the struts to move between a radially-compressed state and a radially-expanded state.

The delivery apparatus includes a handle and (optionally) a shaft assembly coupled to the handle. In some examples, the shaft assembly includes one or more shafts. In some examples, the shaft assembly includes an outer shaft and an inner shaft extending through a lumen of the outer shaft.

In some examples, one or more shafts of a delivery apparatus can include one or more reinforcement layers. The reinforcement layers can be configured to strengthen the shaft, while also allowing the shaft to be sufficiently flexible. As such, the disclosed shafts can withstand the forces applied to the shafts (e.g., during an implantation procedure) and can be navigated through a patient's anatomy (e.g., vasculature).

In some examples, a delivery apparatus includes a handle body, an outer shaft, and an inner shaft. The handle body comprises a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The outer shaft comprises a proximal end movably coupled to the handle body. The inner shaft extends through a lumen of the outer shaft and fixed relative to the handle body. The inner shaft comprises a first reinforcement layer and a second reinforcement layer. The first reinforcement layer extends from a proximal end portion of the inner shaft to a first distal location of the inner shaft. The second reinforcement layer extends from the proximal end portion of the inner shaft to a second distal location of the inner shaft. The second distal location is proximal to the first distal location.

In some examples, a delivery apparatus includes a handle body, an outer shaft, and an inner shaft. The handle body includes a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The outer shaft includes a proximal end movably coupled to the handle body. The inner shaft extends through a lumen of the outer shaft and is fixed relative to the handle body. The inner shaft includes a first braided material comprising a first braid density and a second braided material comprising a second braid density. The second braid density is less than the first braid density.

In some examples, a shaft for a delivery apparatus includes a proximal end, a distal end, a first reinforcement layer, and a second reinforcement layer. The first reinforcement layer extends from a first proximal location of the shaft to a first distal location of the shaft. The second reinforcement layer extends from a second proximal location of the shaft to a second distal location of the shaft, and the second distal location is proximal to the first distal location.

In some examples, a shaft for a delivery apparatus includes a proximal end, a distal end, a first braided material, and a second braided material. The first braided material includes a first braid density. The second braided material includes a second braid density, which is less than the first braid density.

In some examples, a shaft for a delivery apparatus includes a proximal end, a distal end, and a reinforcement layer. The reinforcement layer extends from a first proximal location of the shaft to a distal location of the shaft and comprises a triaxial braided material.

The above devices can be used as part of an implantation procedure performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

DETAILED DESCRIPTION

General Considerations

For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

In the interest of conciseness, and for the sake of continuity in the description, same or similar reference characters may be used for same or similar elements in different figures, and description of an element in one figure will be deemed to carry over when the element appears in other figures with the same or similar reference character. In some cases, the term “corresponding to” may be used to describe correspondence between elements of different figures. In an example usage, when an element in a first figure is described as corresponding to another element in a second figure, the element in the first figure is deemed to have the characteristics of the other element in the second figure, and vice versa, unless stated otherwise.

As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. The word “comprise” and derivatives thereof, such as “comprises” and “comprising,” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.” Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

As used herein, the term “simulation” means a performing an act on a cadaver, cadaver heart, anthropomorphic ghost, and/or a computer simulator (e.g., with the body parts, tissue, etc. being simulated).

Introduction to the Disclosed Technology

This disclosure describes a plurality of delivery apparatus that can be used to deliver prosthetic implants such as docking stations and/or prosthetic heart valves to an implantation location within a patient's anatomy. The delivery apparatus includes a shaft assembly coupled to a handle, which controls operations of the delivery apparatus. A prosthetic implant can be encapsulated within a distal end portion of one of the shafts of the shaft assembly for delivery to the implantation location.

The shaft assembly includes an outer shaft that is movable between an extended position to encapsulate a prosthetic implant loaded onto the delivery apparatus and a retracted position to expose the prosthetic implant for deployment at the implantation location. A carriage member is included in the handle to move the outer shaft between the retracted and extended positions. The shaft assembly includes an inner shaft that extends through the lumen of the outer shaft.

In certain examples, the carriage member and the outer shaft form a gland or annular groove to hold a seal member. In certain examples, the inner shaft includes one or more fluid ports that together with the seal member disposed within the carriage member allow the inner shaft and the outer shaft to be flushed with fluid from a single injection port.

In certain examples, the inner shaft can carry a frame connector having one or more recesses to receive one or more connector tabs of the prosthetic implant and thereby axially restrain the prosthetic implant. In certain examples, the recesses have undercut walls that translate tensile force applied to the connector tabs to radial force acting on the connector tabs, which can help maintain engagement of the connector tabs with the recesses during recompression and/or retrieval of the prosthetic implant.

Also disclosed herein are examples of shafts for a delivery apparatus. The disclosed shafts can include one or more reinforcement layers. The reinforcement layers can be configured to strengthen the shaft, while also allowing the shaft to be sufficiently flexible. As such, the disclosed shafts can withstand the forces applied to the shafts (e.g., during an implantation procedure) and can be navigated through a patient's anatomy (e.g., vasculature).

In some examples, a plurality of reinforcement layers can be provided. In some instances, each reinforcement layer can extend along a different portion of the shaft. In particular instances, the reinforcement layers can axially overlap for at least a portion of the length and/or can be non-overlapping for at least a portion of the length.

In some examples, one or more of the reinforcement layers can include a braided material, such as a metal braid. In examples with a plurality of reinforcement layers, each reinforcement material can be the same or can be different. In certain examples, a first braided material having a first braid density and/or a first wire count can be used as a first reinforcement layer and a second braided material having a second braid density and/or a second wire count can be used as a second reinforcement layer.

Examples of the Disclosed Technology

Turning now to the drawings,FIG.1illustrates an exemplary implementation of a frame100(or stent) that can form a body of a docking station. The frame100has a first end104and a second end108. In some examples, the first end104can be an inflow end, and the second end108can be an outflow end. In some examples, the first end104can be an outflow end, and the second end108can be an inflow end. The terms “inflow” and “outflow” are related to the normal direction of blood flow (e.g., antegrade blood flow) through the frame. In the unconstrained, expanded state of the frame100shown inFIG.1, a relatively narrower portion (or waist)112of the frame100between the first end104and the second end108forms a valve seat116. The frame100can be compressed (as illustrated inFIG.2) for delivery to an implantation location by a delivery apparatus.

Although the docking stations, delivery apparatus, prosthetic heart valves, and/or methods are described herein with respect to a particular implantation location (e.g., a pulmonary valve) and/or a particular delivery approach (e.g., transfemoral), the device and methods disclosed herein can be adapted to various other implantation locations (e.g., an aortic valve, a mitral valve, and a tricuspid valve) and/or delivery approaches (e.g., transapical, transseptal, etc.).

In the example illustrated byFIG.1, the frame100includes a plurality of struts120arranged to form cells124. The ends of the struts120form apices128at the ends of the frame100. One or more of the apices128can include a connector tab132. The portions of the struts120between the apices128and the valve seat116(or the waist112) form a sealing portion130of the frame100. In the unconstrained, expanded state of the frame100illustrated in FIG.1, the apices128extend generally radially outward and are radially outward of the valve seat116.

The frame100can be made of a highly resilient or compliant material to accommodate large variations in the anatomy. For example, the frame100can be made of a flexible metal, metal alloy, polymer, or an open cell foam. An example of a highly resilient metal is Nitinol, which is a metal alloy of nickel and titanium, but other metals and high resilient or compliant non-metal materials can be used. The frame100can be self expanding, manually expandable (e.g., expandable via a balloon), or mechanically expandable. A self-expanding frame can be made of a shape memory material, such as, for example, Nitinol. In this manner, the frame can be radially compressed as depicted inFIG.2(e.g., via a crimping device) and can radially expand to the configuration depicted inFIG.1.

FIG.3illustrates an exemplary docking station136including the frame100and an impermeable material140disposed within the frame. The impermeable material140is attached to the frame100(e.g., by sutures144). In the example illustrated byFIG.3, the impermeable material140covers at least the cells124in the sealing portion130of the frame100. The seal formed by the impermeable material140at the sealing portion130can help funnel blood flowing into the docking station136from the proximal inflow end104to the valve seat116(and the valve once installed in the valve seat). One or more rows of cells124proximate to the distal outflow end108can be open.

The impermeable material140can be a fabric that is impermeable to blood. A variety of biocompatible materials can be used as the impermeable material140, such as, for example, foam or a fabric that is treated with a coating that is impermeable to blood, a polyester material, or a processed biological material, such as pericardium. In one particular example, the impermeable material140can be polyethylene terephthalate (PET).

The docking station136may include a band146that extends around the waist112(or that is integral to the waist) of the frame100. The band146can constrain expansion of the valve seat116to a specific diameter in the deployed state to enable the valve seat116to support a specific valve size. The band146can take on a wide variety of different forms and can be made of a wide variety of different materials. For example, the band146can be made of PET, one or more sutures, fabric, metal, polymer, a biocompatible tape, or other relatively nonexpanding materials known in the art and that can maintain the shape of the valve seat116.

FIG.4illustrates the docking station136in a deployed state within a native valve annulus148. As can be seen, the frame100of the docking station136is in an expanded condition, with the end portions of the frame pressed against the inner surface152of the native valve annulus. The band146(shown inFIG.3) can maintain the valve seat116at a constant or substantially constant diameter in the expanded condition of the frame100.FIG.4also shows a prosthetic valve200deployed within the docking station136and engaged with the valve seat116of the docking station136. The prosthetic valve200can be implanted by first deploying the docking station136at the implantation location and then installing the prosthetic valve within the docking station.

The prosthetic valve200can be configured to replace a native heart valve (e.g., aortic, mitral, pulmonary, and/or tricuspid valves). In one example, the prosthetic valve200can include a frame204and a valvular structure208disposed within and attached to the frame204. The valvular structure208can include one or more leaflets212that cycle between open and closed states during the diastolic and systolic phases of the heart. The frame204can be made of the frame materials described for the frame100of the docking station136. The leaflets212can be made in whole or in part from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art.

The docking station136is not limited to use with the particular example of the prosthetic valve200illustrated inFIG.4. For example, mechanically expandable prosthetic valves such as described in U.S. patent Publication Nos. 2018/0153689 and 2019/0060057; U.S. patent Application No. 62/869,948; and International Application No. PCT/US2019/056865, the relevant disclosures of which are incorporated by reference herein, may be installed in the docking station136.

FIG.5Aillustrates an exemplary delivery apparatus300that can be used to deliver the docking station to an implantation location. The delivery apparatus300generally includes a handle302and a shaft assembly303coupled to the handle302and extending distally from the handle302. The shaft assembly303includes an inner shaft305and an outer shaft309. The inner shaft305extends through a lumen of the outer shaft309.

In the example illustrated byFIG.5A, a frame connector400is coupled to the inner shaft305. The docking station136can be disposed around a portion of the inner shaft305extending distally from the frame connector400, as shown inFIG.5B. In one example, the frame connector400includes one or more recesses that can receive one or more connector tabs132at the proximal end of the docking station136and thereby axially restrain the docking station136.

A nosecone317can be attached to a distal end of the inner shaft305. The nosecone317includes a central opening319for receiving a guidewire. As such, a proximal end of the guidewire can be inserted into the central opening319and through the inner shaft305, and a distal end portion of the delivery apparatus300can be advanced over the guidewire through a patient's vasculature and to an implantation location. The guidewire can pass through the nosecone317into the inner shaft305during advancing of the delivery apparatus through a patient's vasculature.

The handle302can be operated to move the outer shaft309relative to the inner shaft305, generally between an extended position and a retracted position. The handle302can be extended to slide the outer shaft309over the frame connector400and over any docking station coupled to the frame connector400to encapsulate the docking station within the outer shaft309. As the outer shaft309slides over the docking station136, the outer shaft309can compress the docking station136such that the docking station is encapsulated within the outer shaft309in the compressed state. In the fully extended position, a distal end of the outer shaft309can abut a proximal end of the nosecone317such that there are no gaps in the delivery assembly. Additionally or alternatively, a crimping device can be used to radially compress the docking station such that it can be inserted into the outer shaft of the delivery apparatus.

FIGS.6A-7Dillustrate a method of deploying a docking station at an implantation location within an anatomy. For purposes of illustration, the patient's anatomy is omitted. InFIG.6A, the method includes retracting the outer shaft309by the handle of the delivery apparatus to allow loading of the docking station136onto the inner shaft305. InFIG.6B, the method includes disposing the docking station136around the inner shaft305and engaging each of the connector tabs132of the docking station136with the frame connector400. The method also includes positioning the outer shaft309over the docking station such that the docking station is encapsulated therein. This can be accomplished by manipulating the handle of the delivery apparatus. As shown inFIG.6B, the distal end of the outer shaft309abuts the proximal end of the nosecone317. The method includes inserting the delivery apparatus, from the nosecone317end, into a patient's vasculature and advancing the delivery apparatus through the patient's vasculature to the implantation location.

At the implantation location, the method includes retracting the outer shaft309by the handle of the delivery apparatus to expose the docking station136.FIGS.6C-6Fshow different stages of retracting the outer shaft309. As can be seen, in cases where the docking station136is self-expanding, the docking station136gradually emerges from the outer shaft309and gradually expands from the compressed state as the outer shaft309is retracted. When the outer shaft309is sufficiently retracted, the connector tabs132disengage from the frame connector400. Once the docking station136is disengaged from the frame connector400, the docking station136can radially expand to engage the anatomy.

FIGS.7A-7Cillustrate an exemplary implementation of the handle302of the delivery apparatus. The handle302includes a handle body304and a deployment mechanism306coupled to and partially disposed within the handle body. The handle body304includes a proximal end308, a distal end312, and a cavity316extending from the proximal end308to the distal end312. The handle302includes a longitudinal axis315extending from the proximal end308to the distal end312. The longitudinal axis315defines the axial direction of the handle.

The handle body304can be a single piece body with the cavity316. Alternatively, the handle body304can have two body pieces304a,304bthat can be assembled together to form the cavity316. For example, the first body piece304bmay have snap hooks307that snap into complementary recesses in the second body piece304a.

The deployment mechanism306of the handle302includes a carriage member500and a drive member320. The carriage member500is disposed within the cavity316and movable relative to the handle body304in the axial direction. The drive member320engages with the carriage member500and is movable (e.g., rotatable) relative to the handle body304to adjust the axial position of the carriage member500relative to the handle body304.

Proximal portions of the shafts305,309are inserted into the cavity of the handle body304. A proximal end portion of the outer shaft309of the shaft assembly303can be coupled to the carriage member500(e.g., by fasteners, adhesive, and/or other means for coupling) such that movement of the carriage member500relative to the handle body304causes movement of the outer shaft309between the extended and retracted positions.

A proximal portion of the inner shaft305extends through a lumen313of the outer shaft309into a proximal portion of the cavity316and is coupled to the handle body304. The inner shaft305can be fixed relative to the handle body304such that the inner shaft305is stationary while the outer shaft309moves relative to the handle body304.

In the example illustrated byFIGS.7A-7C, an injection port324is mounted at an opening at the proximal end308of the handle body304. The injection port324can be, for example, a Luer fitting. A proximal end of the inner shaft305can be inserted into the injector port324(shown inFIG.11A) and secured to the injection port324(e.g., by bonding). In some cases, the attachment of the inner shaft305to the injection port324can serve the purpose of fixing the inner shaft305relative to the handle body304.

The injection port324can be used to inject flushing fluid, such as saline, into the lumen of the inner shaft305. In some cases, the inner shaft305can include one or more fluid ports311through which the injected fluid exits the inner shaft305and enters the lumen313of the outer shaft309, thereby allowing flushing of the lumens of the inner shaft305and outer shaft309from a single injection port.

FIGS.8A-8Cillustrate an exemplary implementation of the carriage member500. The carriage member500includes a carriage body504having a distal end506and a proximal end510. The carriage body504has a head portion508and a stem portion512between the distal end506and the proximal end510. The carriage body504can be formed (e.g., molded) as a single, unitary component. Preferably, the carriage body504has enough rigidity to support a portion of the shaft assembly received within the handle body304(shown inFIGS.7B and7C).

The head portion508of the carriage body504has an external surface516. External threads518are formed on the portion of the external surface516at opposite sides of the head portion508. The external threads518can engage a complementary internal thread in the drive member320(shown inFIGS.7B and7C) of the handle. The head portion508has an internal surface520that defines an internal bore524configured to receive a portion of the shaft assembly.

The stem portion512includes a central opening532, which is longitudinally aligned with and connected to the internal bore524of the head portion508, forming a passage extending along the entire length of the carriage body504. Longitudinal slots536a,536b(or guide members) are formed on opposite sides of the stem portion512. The longitudinal slot536amay be connected to the central opening532(or to the passage formed by the bore524and central opening532) as illustrated inFIG.8C. The longitudinal slots536a,536bcan receive complementary guide members348a,348b(shown inFIGS.11A and11B) within the elongated cavity of the handle body.

Referring toFIG.9, a locating shoulder540is formed on the internal surface520of the head portion508. The locating shoulder540defines a first stepdown transition in the internal bore524. For example, the locating shoulder540steps down the diameter of the internal bore524from diameter d1to diameter d2, where the diameter d1is greater than the diameter d2. The locating shoulder540is offset from the distal end506of the carriage body504by a distance L1. The locating shoulder540has an annular face that is oriented towards the distal end506and may be referred to as “a distally facing annular shoulder” in some cases.

A gland shoulder544is formed on the internal surface520of the head portion508. The gland shoulder544defines a second stepdown transition in the internal bore524. For example, the gland shoulder544steps down the diameter of the internal bore524from diameter d2to diameter d3, where the diameter d2is greater than the diameter d3. The gland shoulder544is offset from the distal end506of the carriage body504by a distance L2that is greater than the distance L1, which means that the gland shoulder544is located proximally to the locating shoulder540. The gland shoulder544has an annular face that is oriented towards the distal end506and may be referred to as “a distally facing annular shoulder” in some cases.

FIG.10shows the shaft assembly303extending through the passage formed by the internal bore524and the central opening532such that the proximal end (or proximal face) of the outer shaft309is positioned within the internal bore524. The proximal end of the outer shaft309forms a shoulder546that is in opposing relation to and distal relative to the gland shoulder544. The outer shaft309can be secured to the head portion508of the carriage member500in this position (e.g., via fasteners, adhesive, and/or other means for coupling). An annular groove548(or gland) is defined within the internal bore524by the opposed shoulders544,546and the portion of the internal surface520between the opposed shoulders544,546. The annular groove548can receive a seal member552.

In some examples, the locating shoulder540can act as a stop surface for the proximal end of the outer shaft309. In this case, the diameter d2(shown inFIG.9), which corresponds to the inner diameter of the locating shoulder540, can be selected to be larger than an inner diameter of the outer shaft309at the proximal end of the outer shaft309such that when the proximal end of the outer shaft309abuts the locating shoulder540, a portion of the proximal end of the outer shaft309forms the shoulder546at the first stepdown transition. As shown for example inFIG.10, the shoulder546formed by the proximal end of the outer shaft309can be radially inward of the locating shoulder540at the first stepdown transition.

In some examples, the carriage body504can be formed without the locating shoulder540, and the outer shaft309can be inserted into the internal bore524to a point at which the proximal face of the outer shaft309abuts the distal face of the seal member522, which would at the same time form the distal end of the annular groove548.

As illustrated byFIG.10, the inner shaft305extending through the lumen of the outer shaft309passes through the portion of the internal bore524between the opposed gland shoulders544,546, which means that the annular groove548is disposed around a circumference of the inner shaft305. Thus, the seal member552disposed in the annular groove548can form a seal between the inner shaft305and the internal surface520and at the proximal end of the outer shaft309. The seal member552can cycle between dynamic sealing and static sealing. Dynamic sealing occurs when the seal member552slides along the inner shaft305as the carriage member500moves relative to the handle body304(shown inFIGS.7B and7C). In this manner, the seal member552can also be referred to as “a wiper seal.” The seal member552can be any suitable seal (e.g., an O-ring).

The gland shoulder544forms the proximal end of the annular groove548(or the proximal gland shoulder), and the proximal end (or proximal face) of the outer shaft309forms the distal end of the annular groove548(or the distal gland shoulder). In some cases, the locating shoulder540can form a stop for the outer shaft309. Forming the shoulders of the carriage body as stepped shoulders can, among other things, allow the carriage body504(or carriage member500) to be molded as a single piece. The molding process can include forming a mold cavity for the carriage body and a core pin to form the internal bore including the locating and gland shoulders540,544. The core pin is secured within the mold cavity, and molten thermoplastic material is injected into the mold cavity to form the molded body. The stepped shoulders can, for example, allow the core pin to be easily removed from the distal end of the molded part. As such, the disclosed configuration simplifies both manufacture and assembly of the handle as one exemplary advantage.

Returning toFIG.7C, the carriage member500is axially movable within the cavity316and relative to the handle body304by rotation of the drive member320. In the example illustrated byFIG.11A, the drive member320has a barrel portion320aextending into the cavity316from the distal end312of the handle body304and a knob portion320bprojecting from the distal end312of the handle body304. The barrel portion320ahas a ring member332that extends into a recess336in the handle body304. A distal face of the ring member332can abut a proximal face of the recess336to limit movement of the drive member320in the distal direction.

The drive member320includes an internal surface328that defines an internal bore340. The internal surface328includes an internal thread344, which is complementary to the external threads518(shown inFIGS.8A and8B) on the head portion of the carriage member500. As shown, the carriage member500extends into the internal bore340such that the external threads518on the head portion of the carriage member500are engaged with the internal thread344in the drive member320.

Rotation of the knob portion320bcauses rotation of the drive member320relative to the handle body304, which causes the carriage member500to move along the internal bore340of the drive member320. The threads344,518translate the rotary motion of the drive member320to a linear motion of the carriage member500. However, other mechanisms besides a lead screw mechanism can be used to translate the carriage member500axially relative to the handle body304.

Referring toFIGS.11A and11B, the handle body304can include flattened projections348a,348b(or guide members) extending into the cavity316. The flattened projections348aare received in the longitudinal slot536aof the carriage member500. The flattened projection348bis received in the longitudinal slot536b.The longitudinal slots536a,536bmove along respective flattened projections348a,348bas the carriage member500moves axially within the cavity316and relative to the handle body304. The flattened projections348a,348bare longitudinally aligned with the handle body304and cooperate with the longitudinal slots536a,536bto prevent rotation of the carriage member500when the drive member320is rotated.

FIG.12Ashows a proximal portion of the shaft assembly303(i.e., the portion of the shaft assembly303immediately coupled to the handle). The proximal portion of the shaft assembly303includes a proximal portion of the outer shaft309and a proximal portion of the inner shaft305extending through the lumen313of the outer shaft309. As previously described with respect toFIG.11A, the proximal end of the outer shaft309is received within the carriage member500, and the inner shaft305extends through the outer shaft309and through the carriage member. As shown inFIG.12A, the proximal end portion of the inner shaft305includes the proximal end305athat can be fluidly connected to the injection port324(shown inFIGS.7A-7C and11A) and the fluid ports311that allow fluid injected into the inner shaft305at the injection port to exit the inner shaft305and enter the lumen313of the outer shaft309.

In one implementation, the inner shaft305includes a reinforced tube321. In the example illustrated byFIG.12B, the reinforced tube321can include an inner layer325, a reinforcement layer329disposed over the inner layer325, and an outer layer333disposed over the reinforcement layer329. The inner layer325, the reinforcement layer329, and the outer layer333can be in the form of tubes extending substantially along the length of the inner shaft305.

The reinforcement layer329can extend along various portions of the inner shaft305. In some examples, the reinforcement layer329can extend from the proximal end305(e.g., adjacent the injection port324) to the distal end of the inner shaft305(e.g., adjacent or at least partially axially overlapping with the nosecone317). In some examples, the reinforcement layer329can extend along a lesser portion of the inner shaft (e.g., from the proximal end305ato the portion of the inner shaft to which the frame connector400is mounted).

The reinforcement layer329can be, for example, a braided tube, which can be made from metal wire (such as stainless-steel wire or Nitinol wire) or from synthetic fibers (e.g., Kevlar). The wires can comprise various cross-sectional profiles taken in a plane perpendicular to the longitudinal axis of the wires. For example, the cross-sectional profile can be round, rectangular, etc.

In braided configurations, the reinforcement layer can be formed of a braid comprising 4-32 wires (or 8-24 wires in certain examples). In particular examples, the reinforcement layer can comprise 10-20 wires. In certain examples, the reinforcement layer can comprise a 16-wire braid. The braid densities can also vary. For example, the braid density of the reinforcement layer can be within a range of 40-60 picks per inch (PPI). In certain examples, the braid density can be 45 PPI.

The reinforcement layer can comprise one or more axially-extending elements (e.g., wires, fibers, etc.) in lieu of or in addition to the braided material. For example, a plurality of wires can extend axially along all or a portion of the length of the inner shaft. These wires differ from the braided wires because they do not intersect with each other (though they may intersect with the braid—which in some instances can be called a “triaxial braid”). In other words, these wires are spaced circumferentially relative to each other around the inner shaft.

The reinforced tube321can be configured as a flexible tube to facilitate movement of the tube through the vasculature of a patient. The inner layer325and the outer layer333can be tubes made of a polymer material. Examples of suitable polymer materials include, but are not limited to, PEBAX® elastomers, nylons, and polyurethane. The inner layer325and outer layer333can be made of the same material or of different materials. In some cases, the reinforced tube321can be made by extrusion.

The inner shaft305can include one or more fluid ports. The fluid ports are formed in the wall of the reinforced tube and can allow a flushing fluid to flow from the inner lumen of the inner shaft and into the lumen of the outer shaft309. In this manner, the fluid ports311enable flushing of the inner shaft305and the outer shaft309from a single injection port rather than requiring the shafts to be separately flushed. Referring toFIGS.12B and12C, each fluid port311includes a first opening325ain the inner layer325, a second opening333ain the outer layer333that is radially aligned with the first opening, and the pores (or openings) in the portion329aof the reinforcement layer329between the two openings325a,333a.The openings325a,333acan have any suitable shape (e.g., oval as shown inFIGS.12A and12C, circular, square, or rectangular shape).

Any number of fluid ports311can be formed in the reinforced tube321. For example, the illustrated reinforced tube321comprises four ports311(shown inFIG.12B). When there are multiple fluid ports311, various arrangements of the fluid ports311on the reinforced tube321are possible. For example,FIGS.12A-12Cshow two of the fluid ports311spaced apart axially and aligned circumferentially along the reinforced tube321. As depicted inFIG.12B, the reinforced tube321also comprises two additional fluid ports311that are axially aligned and circumferentially spaced apart (e.g., by 180 degrees) from the fluid ports depicted inFIG.12C. In some examples, the fluid ports311can be spaced apart and/or staggered around the reinforced tube321. For example, the fluid ports311can be spaced apart and staggered around the reinforced tube321to form a spiral pattern. In some examples, the fluid ports can form an alternating-type pattern such that a first side of the tube comprises a plurality of ports (e.g., a first proximal port and a first distal port), and a second side of the tube (e.g., located 180 degrees from the first side) comprises a plurality of ports (e.g., a second proximal port and a second distal port), and the ports are arranged axially in the following manner moving proximal to distal: first proximal port, second proximal port, first distal port, second distal port.

The inner shaft305can, in some instances, include a cover tube337extending over a proximal portion of the reinforced tube321. The cover tube337includes one or more windows341positioned to expose the fluid ports311. The cover tube337is the part of the inner shaft305that contacts the seal member552(shown inFIG.11A) when the inner shaft305extends through the carriage member500(shown inFIG.11A). The cover tube337is preferably a rigid member that can support sliding of the seal member. The cover tube337preferably has a surface finish to provide a proper sealing surface to the seal member552. The cover tube337can be made of metal or plastic. For example, the cover tube337can be made from stainless steel. The cover tube337can be secured to the reinforced tube321by any suitable method, such as by crimping, adhesive, etc.

Referring toFIGS.11A and12A, fluid (e.g., saline) can be injected into the inner shaft305through the injection port324for the purpose of flushing the inner shaft. The fluid will move through the lumen of the inner shaft305. A portion of the fluid moving through the lumen of the inner shaft305will exit through the fluid ports311and enter the lumen313of the outer shaft309, allowing flushing of the outer shaft. Thus, both the inner shaft305and the outer shaft309can be flushed using a single injection port. The seal member552forms a seal at the proximal end of the outer shaft309and prevents leakage of the fluid from the proximal end of the outer shaft. Later, during use of the delivery apparatus, the seal member552will also prevent leakage of blood from the proximal end of the outer shaft, thereby maintaining hemostasis.

Returning toFIGS.6A-6F, the docking station136can be configured as a self-expanding docking station where the docking station136and the connector tabs132are naturally biased toward an expanded configuration. While the docking station136is attached to the delivery system, the docking station136is compressed to a smaller configuration (shown inFIG.6B) for insertion and tracking through the vasculature. The compressed configuration of the docking station is held in place axially by the frame connector400(which is fixed relative to the inner shaft305) and held in place radially by the outer shaft309. The docking station136is therefore prevented from premature deployment by the frame connector400and the outer shaft309. Once the docking station136is at the implantation location within the anatomy, the outer shaft309can be retracted to expose and deploy the docking station136.

As the outer shaft309is retracted to expose the docking station136, the distal portion of the docking station136expands (as shown, for example, inFIGS.6C and6D). In some cases, prior to completing retraction of the outer shaft309, it may be desirable to reposition and/or retrieve the docking station136. In this case, the outer shaft309may be extended again to recapture and recompress the docking station136in order to allow the docking station136to be repositioned and/or retrieved. However, the bias toward an expanded configuration can create an axial tension between the docking station and the frame connector. The axial tension can concentrate at the flanges of the connector tabs of the docking station as the outer shaft is extended distally over the docking station for recapture. Due to the relatively high forces during recapture and/or retrieval, the connector tabs of the docking station tend to move radially outwardly attempting to disengage from the frame connector400. This can increase the force required to recapture the docking station. In extreme instances, the connector tabs can disengage from the connector, which can inhibit recompression and/or retrieval of the docking station.

FIGS.13A-17Billustrate an exemplary implementation of the frame connector400that can help retain the connector tabs in the radially-compressed configuration during recompression/retrieval of the docking station. Referring toFIGS.13A and13B, the frame connector400includes a connector body404, a flange408attached to one end of the connector body404, and a flange412attached to another end of the connector body404. The flange408provides a proximal end410of the connector, and the flange412provides a distal end414of the connector. The frame connector400has a longitudinal axis415(or central axis) extending from the proximal end410to the distal end414. The longitudinal axis415defines the axial direction of the connector.

As shown inFIG.14, the frame connector400has an internal bore413extending through the flanges408,412and connector body404and along the longitudinal axis (415inFIG.13B). The internal bore413can receive a proximal portion of the inner shaft of the shaft assembly of the delivery apparatus. The flange408can include radial holes406that connect to the internal bore413. As will be described later, the radial holes406can play a role when the frame connector400is fixed to the inner shaft of the shaft assembly (e.g., by an over-molding process).

Returning toFIGS.13A and13B, the connector body404includes an exterior with an exterior surface416and one or more recesses420. Each of the recesses420can receive one of the connector tabs of the docking station. In the implementation illustrated byFIGS.13A-17B, two recesses420are formed in diametrically opposed positions on the exterior of the connector body404. In general, when a plurality of recesses420are formed on the exterior of the connector body404, the recesses420can be formed in angularly (which may also be referred to as “circumferentially”) spaced apart locations along the exterior of the connector body404(i.e., distributed along a circumference of the connector body404).

Referring still toFIGS.13A and13B, each recess420can be a recessed slot having a first slot portion420aand a second slot portion420barranged to form a “T” shape. As shown, the first slot portion420ais generally aligned with the longitudinal axis415of the connector and is generally perpendicular to the second slot portion420b.The first slot portion420ahas a first width W1, and the second slot portion420bhas a second width W2. The second width W2is greater than the first width W1, which means that the recess420transitions from a larger width slot portion420bto a smaller width slot portion420a.As shown inFIG.15, the recess420is open at the exterior surface416so that a connector tab132having a flared portion132acan be positioned in the recess from the exterior surface416.

Referring toFIGS.13A and16A, each recess420has a recess floor424, opposite side walls428,429, and an end wall430. The side walls428,429project from opposite sides of the recess floor424. The side wall428is connected to a portion417of the exterior surface416. The side wall429is connected to a portion418of the exterior surface416. The end wall430projects from an end of the recess floor424and is connected to a portion419of the exterior surface416. The recess floor424is on a different plane compared to the surface portions417,418,419. In particular, the recess floor424is recessed (or radially inward) relative to the surface portions417,418,419, as shown more clearly inFIG.16A.

In one example, the surface portions417,418are on the same plane but on a different plane compared to the surface portion419. For example, as shown inFIG.13B, each of the surface portions417,418can be radially outward of the surface portion419by an offset distance d. Stated differently, the height h1of the side walls428,429relative to the recess floor424can be greater than the height h2of the end wall430relative to the recess floor424. Since the connector tab that is received in the recess420will contact the side walls428,429, the height of the side walls428,429can be selected to provide sufficient engagement surfaces for the connector tab.

A first portion428aof the side wall428and a first portion429aof the side wall429form opposite sides of the first slot portion420a(inFIG.13A) of the recess420. The end wall430is longitudinally displaced from the first and second walls428,429by a distance that determines the height of the second slot portion420b(inFIG.13A) of the recess420. A second portion428bof the side wall428and a second portion429bof the side wall429are in opposing relation to the end wall430. The end wall430and the second portions428b,429bof the side walls428,429form opposite ends of the second slot portion420bof the recess420.

FIG.15shows a connector tab132of a docking station positioned within a recess420of the frame connector400prior to deployment of the docking station at an implantation location. The connector tab132can be formed at an apex of a strut120of the frame of the docking station as previously described. In the example illustrated byFIG.15, the connector tab132has a flared portion132athat sits in the second slot portion420band engages the side walls428,429. The flared portion132aengages the side walls428,429because the flared portion132ais wider than the first slot portion420a.When the flared portion132aengages the side walls428,429as shown, the connector tab132is prevented from being pulled axially through the first slot portion420a.

To help retain the connector tab132in the radially-compressed configuration and thus its connection with the frame connector400when axial tension is created between the docking station and the frame connector, the second portions428b,429bof the side walls428,429are formed as undercut walls, which means that there is a space or recess underneath each of the second portions428b,429b(or a space or recess between each of the second portions428b,429band the recess floor424). As illustrated inFIGS.17A and17B, the second portions428b,429b,which are formed as undercut walls, are inclined relative to the recess floor424(i.e., the second portions428b,429bare not perpendicular to the recess floor424). The angle α between the second portion428band the recess floor424is less than 90 degrees, and the angle θ between the second portion429band the recess floor424is less than 90 degrees. In some examples, each of the angles α and θ can be in a range of 45-89.9 degrees. In some examples, each of the angles α and θ can be in a range of 75-89.9 degrees. In one preferred example, each of the angles α and θ can be in a range of 81-86 degrees. The angles α and θ can be the same or can be different.

When the frame connector400as illustrated byFIGS.17A and17Bis used to axially restrain the docking station136, the tensile force created by the bias of the docking station to the expanded configuration pulls the flared portion (132ainFIG.15) of the connector tab axially against the second portions428b,429b.The undercut in the second portions428b,429btranslates a portion of the tensile force into a radial force that pushes the connector tab radially inwardly toward the central axis of the frame connector400, thereby improving retention characteristics of the docking station prior to deployment of the docking station. It has been found that each of the angles α, θ between the second portions428b,429band the recess floor424in a range of 81-86 degrees (in certain instances) improves securement of the docking station to the delivery system when the outer shaft is extended during recapture of the docking station.

Returning toFIGS.13A and16A, the first portions428a,429acan be formed as undercut walls, which means that there is a space or recess underneath each of the first portions428a,429a(or a space or recess between each of the first portions428a,429aand the recess floor424). As illustrated inFIG.16B, the first portions428a,428bas undercut walls are inclined relative to the recess floor424(i.e., the first portions428a,429bare not perpendicular to the recess floor424). The angle β between the first portion428aand the recess floor424is less than 90 degrees, and the angle φ between the first portion429aand the recess floor424is less than 90 degrees. In some examples, each of the angles β and φ can be in a range of 45-89.9 degrees. In some examples, each of the angles β and φ can be in a range of 75-89.9 degrees. In one example, each of the angles β and φ can be in a range of 81-86 degrees. The angles β and φ can be the same or can be different. In some examples, the angles β and/or φ can be the same as the angles α and/or θ. In some examples, the angles β and/or φ can be different than the angles α and/or θ.

Returning toFIG.13A, each of the side walls428,429includes a corner where the first slot portion420ais connected to the second slot portion420b.These corners can be rounded and can have undercuts such that an undercut extends underneath the entire length of each of the side walls428,429. The edges where the side walls428,429meet the exterior surface portions417,418can be similarly rounded.

Referring toFIG.18, one preferred method of coupling the frame connector400to a distal portion of the inner shaft305(shown inFIG.5A) is by an over-molding process. During the over-molding process, the radial holes406in the flange408can receive flow of injected material. The material in the radial holes406, when solidified, can anchor the frame connector400to the inner shaft305.FIG.18shows the inner shaft305extending through the lumen of the outer shaft309. The frame connector400is sized relative to the outer shaft309such that the outer shaft309can be extended over the frame connector400and over a docking station disposed around a portion of the inner shaft305distal to the frame connector400.

FIGS.19and20illustrate a portion of the delivery apparatus300including the docking station136in a compressed configuration. The outer shaft309is extended to encapsulate the docking station136. Each of the connector tabs132of the docking station136is disposed in a respective recess420of the frame connector400and engaged with the side walls of the recess420. The docking station136is held in place axially by the frame connector400and radially by the outer shaft309. It should be understood that only a portion of the delivery apparatus is shown inFIGS.19and20. The remaining portions of the delivery apparatus (e.g., the portion that extends to the nosecone, the portion that is coupled to the handle, the nosecone, and the handle) are visible inFIGS.5A.

A delivery assembly that is configured as shown inFIGS.19and20can be inserted into a patient's body and advanced through the patient's vasculature to an implantation location. At the implantation location, the outer shaft309can be retracted to expose the docking station136and deploy the docking station (as illustrated inFIGS.6C-6F). During recapture of the docking station136, the inner shaft305can be under high tensile loads while the outer shaft309is extended to cover docking station136. The undercut in the side walls of the recess420can translate the tensile force acting on the respective connector tab132to a radial force that pushes the connector tab132inwardly toward the central axis of the frame connector400, as illustrated inFIG.21, thereby retaining the connection between the delivery apparatus and the docking station.

FIGS.22-30depict various shafts for a delivery apparatus. These shafts can, in some instances, be used with the delivery apparatus300in lieu of the inner shaft305. As such, these shafts can, in some instances, be referred to as “inner shafts.” The disclosed shafts can additionally or alternatively be used with other delivery apparatus, such a delivery apparatus configured for implanting a prosthetic heart valve. The shafts depicted inFIGS.22-30are generally similar to the shaft305, except the shaft ofFIGS.22-30include one or more additional reinforcement elements (e.g., additional layers and/or members).

FIGS.22-23depict an example of a shaft600. The shaft600comprises a first layer602, a second layer604, a third layer606, and a fourth layer608. The first layer602and the fourth layer608can be liner/cover layers. The second layer604and the third layer606can be reinforcing layers configured to strengthen the shaft600, including when the shaft600is in tension (e.g., during recapture of a docking station).

The layers of the shaft600can be formed of various materials. For example, the first layer602and the fourth layer608of the shaft600can be made of a polymeric material. Examples of suitable polymeric materials include: PEBAX®, nylons, and/or polyurethane. The first layer602and the fourth layer608can be made of the same material or of different materials. In some examples, the first layer602and/or the fourth layer608can be made by extrusion.

The second layer604and the third layer606can be made of various materials. For example, in some instances, the second layer604and the third layer606can be formed of a braided material, one or more non-braided materials, woven material, and/or other material. In some examples, the second layer604and/or the third layer606can comprise one or more materials configured to carry the loads (e.g., tensile loads) applied to the shaft600.

In instances comprising a braided material, a metal and/or non-metal braid can be used. Examples of metal braids include stainless steel, nitinol, and titanium, to name a few. Examples of non-metal braids include Kevlar, sutures, etc.

In some examples, the layers of the shaft600can be discrete layers (i.e., without radial overlap). In other words, each layer is “stacked on” a previous layer or “sandwiched” between two layers. In some examples, the layers of the shaft600radially overlap. This can be accomplished by reflowing the polymeric layers on the reinforcing layers. As such, the polymeric material can flow radially around and/or into the non-polymeric layers (e.g., into the openings of the braid, weave, etc.). In this manner, the reinforcing layers can, in some instances, be encapsulated in or surrounded by the polymeric material.

The second layer604and the third layer606can be made of the same or of different materials. As one example, the second layer604can comprise a first braided material having a first braid density, and the third layer606can comprise a second braided material having a second braid density, which is different (e.g., less) than the first braid density. In particular examples, the first braided material and the second braided material can be stainless steel braids. The braids can comprise various numbers of wires such as 4-32 wires. In certain examples, one or more of the braids can be 16-wire braids. The braid densities can also vary. For example, in some implementations, the first braid density can be within a range of 40-60 picks per inch (PPI), and the second braid density can be within a range of 5-20 PPI. In some examples, the first braid density can be 38-55 PPI (or 38-52 PPI) and/or the second braid density can be 1-10 PPI (or 2-8 PPI). In some examples, the first braid density can be 45 PPI and/or the second braid density can be 10 PPI. In some examples, the first braid density can be 45 PPI and/or the second braid density can be 5 PPI. The various braid densities described above apply to any of the braids disclosed here, unless explicitly stated otherwise.

The second layer604and the third layer606can extend along the same or different lengths of the shaft600. As one example, the second layer604and/or the third layer606can extend from the proximal end of the shaft600to the distal end of shaft. In some examples, the second layer604and/or the third layer606can extend less than the entire length of the shaft600.

In certain configurations, the second layer604can extend from the proximal end of the shaft600to a location adjacent or at the portion of the shaft600configured to have a nosecone coupled thereto. The third layer606can extend from the proximal end of the shaft600to a location proximal to the distal end of the second layer604(e.g., to a location of the shaft600configured to have a frame connector coupled thereto). In some examples, the third layer606can axially overlap with at least a portion of the frame connector. In some examples, the third layer606can extend to a location proximal to the proximal end of the frame connector. The relative locations of the reinforcement layers described with respect to the shaft600apply to the other shafts disclosed herein, unless explicitly stated otherwise.

The configuration of the shaft600(e.g., depicted inFIGS.22-23) comprising a first, more densely braided material and a second, less densely braided material and/or having the first braided material run the entire length (or at least substantially the entire length) of the shaft and having the second braided material run a lesser portion of the length of the shaft can provide one or more advantages. For example, this configuration allows the shaft to be sufficiently flexible such that it can be navigated through a patient's winding vasculature, while also providing sufficient tensile strength to withstand the forces applied to the shaft, including when recapturing a prosthetic implant, which applies relatively high forces (e.g., tensile forces) to the shaft.

As depicted inFIG.23, the shaft600can, in some instances, include one or more fluid ports610. The fluid ports610extend radially through the shaft600and can allow a flushing fluid to flow from the inner lumen of the shaft600and into the lumen of the outer shaft of a delivery apparatus. In this manner, the fluid ports610enable flushing of the shaft600and the outer shaft from a single injection port (e.g., at the proximal end of the shaft600) rather than requiring the shafts to be separately flushed. The shaft600can also have the cover tube612coupled thereto, which comprises the window614. In some examples, the fluid ports610can be formed by removing the polymeric material of the shaft600(e.g., by ablation) and leaving the reinforcing layers604,606in place. Additional information regarding the forming of the ports610can be found in International Application No. PCT/US2022/018093, which is incorporated by reference herein.

FIG.24depicts a shaft700. The shaft700comprises a first layer702, a second layer704, a third layer706, and a fourth layer708. The first layer702and the fourth layer708can be liner/cover layers. The second layer704and the third layer706can be reinforcing layers configured to strengthen the shaft700, including when the shaft700is in tension (e.g., during recapture of a docking station). In this manner, the shaft700is configured generally similar to shaft600.

One difference between the shaft700and the shaft600is that the second layer704of the shaft700comprises a less densely braided material and the third layer706of the shaft700comprises a more densely braided material. The reinforcement layers of the shaft700are thus inverted relative to the shaft600in which the second layer604comprises a more densely braided material and the third layer606comprises a less densely braided material.

FIG.25depicts a shaft800. The shaft800comprises a first layer802, a second layer804, a third layer806, and a fourth layer808. The first layer802and the fourth layer808can be liner/cover layers. The second layer804and the third layer806can be reinforcing layers configured to strengthen the shaft800, including when the shaft800is in tension (e.g., during recapture of a docking station). In this manner, the shaft800is configured generally similar to shaft600.

One difference between the shaft800and the shaft600(and the shaft700) is that the third layer806of the shaft800comprises a plurality of axially-extending reinforcing members810extending therethrough rather than comprising a braided material like the third layer606of the shaft600.

The number, size (e.g., diameter, length, etc.), material, and location of the reinforcing members810can vary. The depicted example includes eight reinforcing members810. In some examples, the shaft can comprise less (e.g., 1-7) or more (e.g., 9-25) than eight reinforcing members. In some instances, the reinforcing members810can be spaced apart circumferentially such that there is a gap between at least some of the adjacent reinforcing members. The spacing between each of the reinforcing members can be uniform (e.g., as depicted) or non-uniform. In some instances, one or more adjacent reinforcing members can contact each other such that there is no gap.

FIG.26depicts a shaft900. The shaft900is configured similar to the shaft800, except that the second layer904comprises the reinforcing members910and the third layer906comprises the braided material, which is inverted relative to the configuration of the reinforcement layers of the shaft800.

FIG.27depicts a shaft1000. The shaft1000is configured similar to the shafts600and800, except that the third layer1006comprises a triaxial braided material. A triaxial braided material may be viewed as a combination of a “regular” braided material, where the braided members are diagonal to the longitudinal axis of the shaft, and axially-extending members, which extend parallel to the longitudinal axis of the shaft.

FIG.28depicts a shaft1100. The shaft1100is similar to the shaft1000, except the second layer1104comprises the triaxial braid and the third layer comprises the “regular” braid, which is inverted relative to the shaft1000.

FIG.29depicts a shaft1200. The first layer1202and the fourth layer1208comprises polymeric material. The second layer1204and the third layer1206each comprise a triaxial braid. In the depicted configuration, the triaxial braid of the second layer1204has a higher braid density than the triaxial braid of the third layer1206. In some examples, the triaxial braid of the second layer can have a lower braid density than the triaxial braid of the third layer.

FIG.30depicts a shaft1300. This shaft comprises three layers. The first layer1302and the third layer1306comprises polymeric material. The second layer1304comprises a triaxial braid.

It should be noted that a shaft can comprise more or less layers than depicted in the illustrated examples. For example, a shaft can comprise a lubricious layer disposed radially inwardly of the first layer. As one example, a shaft can comprise a third reinforcing layer disposed adjacent to one or more other reinforcing layers.

It should be noted that the dimensions (e.g., diameters and/or relative thicknesses) of the shafts disclosed herein are schematic are intended to illustrate the various layers. The dimensions can be altered based on the desired implementation.

The various shaft configurations described herein can be sufficiently flexible, thereby allowing the shaft (and a delivery apparatus of which the shaft is a component) to be navigated through a patient's vasculature. The disclosed shafts can also provide sufficient strength to withstand the various loads that are applied to the shafts (e.g., during an implantation procedure). Although the shafts have similarities, each shaft configuration can provide unique advantages.

Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

ADDITIONAL EXAMPLES OF THE DISCLOSED TECHNOLOGY

In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

Example 1. A delivery apparatus comprising a handle body, an outer shaft, and an inner shaft. The handle body comprises a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The outer shaft comprises a proximal end movably coupled to the handle body. The inner shaft extends through a lumen of the outer shaft and fixed relative to the handle body. The inner shaft comprises a first reinforcement layer and a second reinforcement layer. The first reinforcement layer extends from a proximal end portion of the inner shaft to a first distal location of the inner shaft. The second reinforcement layer extends from the proximal end portion of the inner shaft to a second distal location of the inner shaft. The second distal location is proximal to the first distal location.

Example 2. The delivery apparatus of any example herein, and particularly example 1, wherein the first distal location axially overlaps with a nosecone coupled to the inner shaft.

Example 3. The delivery apparatus of any example herein, and particularly either example 1 or example 2, wherein the second distal location axially overlaps with a frame connector coupled to the inner shaft.

Example 4. The delivery apparatus of either claim1or claim2, wherein the second distal location is proximal to a distal end of a frame connector coupled to the inner shaft.

Example 5. The delivery apparatus of either claim1or claim2, wherein the second distal location is proximal to a distal end of a frame connector coupled to the inner shaft and distal to a proximal end of the frame connector.

Example 6. The delivery apparatus of either claim1or claim2, wherein the second distal location is proximal to a proximal end of a frame connector coupled to the inner shaft.

Example 7. The delivery apparatus of any example herein, and particularly any one of examples 1-6, wherein the first reinforcement layer and the second reinforcement layer extend proximally to a proximal end of the inner shaft.

Example 8. The delivery apparatus of any example herein, and particularly any one of examples 1-7, wherein the proximal end portion of the inner shaft is configured to be disposed outside of a patient's body during an implantation procedure.

Example 9. The delivery apparatus of any example herein, and particularly any one of examples 1-8, wherein the first reinforcement layer comprises a first braided material.

Example 10. The delivery apparatus of any example herein, and particularly example 9, wherein the first braided material comprises metal wires.

Example 11. The delivery apparatus of any example herein, and particularly either example 9 or example 10, wherein the first braided material comprises a first braid density that is within a range of 5-60 PPI.

Example 12. The delivery apparatus of any example herein, and particularly example 11, wherein the first braided material comprises a first braid density that is within a range of 40-60 PPI.

Example 13. The delivery apparatus of any example herein, and particularly example 12, wherein the first braid density is 45 PPI.

Example 14. The delivery apparatus of any example herein, and particularly example 11, wherein the first braid density is within a range of 5-20 PPI.

Example 15. The delivery apparatus of any example herein, and particularly example 14, wherein the first braid density is 10 PPI.

Example 16. The delivery apparatus of any example herein, and particularly any one of examples 1-11, wherein the second reinforcement layer comprises a second braided material.

Example 17. The delivery apparatus of any example herein, and particularly example 16, wherein the second braided material comprises metal wires.

Example 18. The delivery apparatus of any example herein, and particularly either example 16 or example 17, wherein the second braided material comprises a second braid density that is within a range of 5-60 PPI.

Example 19. The delivery apparatus of any example herein, and particularly example 18, wherein the second braid density is within a range of 40-60 PPI.

Example 20. The delivery apparatus of any example herein, and particularly example 18, wherein the second braid density is 45 PPI.

Example 21. The delivery apparatus of any example herein, and particularly example 18, wherein the second braid density is within a range of 5-20 PPI.

Example 22. The delivery apparatus of any example herein, and particularly example 21, wherein the second braid density is 10 PPI.

Example 23. The delivery apparatus of any example herein, and particularly any one of examples 1-22, wherein the first reinforcement layer is disposed radially inwardly relative to the second reinforcement layer.

Example 24. The delivery apparatus of any example herein, and particularly any one of examples 1-22, wherein the first reinforcement layer is disposed radially outwardly relative to the second reinforcement layer.

Example 25. The delivery apparatus of any example herein, and particularly any one of examples 1-24, wherein the first reinforcement layer is a triaxial braided material.

Example 26. The delivery apparatus of any example herein, and particularly any one of examples 1-25, wherein the second reinforcement layer is a triaxial braided material.

Example 27. The delivery apparatus of any example herein, and particularly any one of examples 1-26, wherein the inner shaft further comprises one or more polymeric layers disposed radially inwardly relative to the first reinforcement layer or the second reinforcement layer.

Example 28. The delivery apparatus of any example herein, and particularly any one of examples 1-27, wherein the inner shaft further comprises one or more polymeric layers disposed radially outwardly relative to the first reinforcement layer or the second reinforcement layer.

Example 29. A delivery apparatus comprising a handle body, an outer shaft, and an inner shaft. The handle body includes a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The outer shaft includes a proximal end movably coupled to the handle body. The inner shaft extends through a lumen of the outer shaft and is fixed relative to the handle body. The inner shaft includes a first braided material comprising a first braid density and a second braided material comprising a second braid density. The second braid density is less than the first braid density.

Example 30. The delivery apparatus of any example herein, and particularly example 29, wherein the first braided material is disposed radially inwardly relative to the second braided material.

Example 31. The delivery apparatus of any example herein, and particularly example 29, wherein the first braided material is disposed radially outwardly relative to the second braided material.

Example 32. A shaft for a delivery apparatus comprising a proximal end, a distal end, a first reinforcement layer, and a second reinforcement layer. The first reinforcement layer extends from a first proximal location of the shaft to a first distal location of the shaft.

The second reinforcement layer extends from a second proximal location of the shaft to a second distal location of the shaft, and the second distal location is proximal to the first distal location.

Example 33. A shaft for a delivery apparatus comprising a proximal end, a distal end, a first braided material, and a second braided material. The first braided material includes a first braid density. The second braided material includes a second braid density, which is less than the first braid density.

Example 34. A shaft for a delivery apparatus comprising a proximal end, a distal end, and a reinforcement layer. The reinforcement layer extends from a first proximal location of the shaft to a distal location of the shaft and comprises a triaxial braided material.

Example 35. A method comprising sterilizing any one of the docking stations or frames of any example herein, and particularly any one of examples 1-34.

Example 36. A method of implanting a prosthetic device comprising any one of the devices disclosed herein, and particularly any one of the devices of examples 1-34.

Example 37. A method of simulating an implantation procedure for a prosthetic device comprising any one of the devices disclosed herein, and particularly any one of the devices of examples 1-34.

The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated.

In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.