Low profile support frame and related intraluminal medical devices

A low profile support frame for use as an or in an expandable intraluminal medical device includes first and second wire members that define arcuate paths having opposing curves. Connectors join the wire members, and barbs can be disposed on the connectors. The support frame has radially compressed and radially expanded configurations. When the support frame is in the radially expanded configuration, substantially no portion of the support frame is disposed on a first transverse axis of the frame opposite one end of the frame and substantially no portion of the frame is disposed on a second transverse axis of the frame opposite the other end of the frame. The support frame can be used as an intraluminal medical device by itself or as a component in a medical device that includes other components, such as a stent, prosthetic valve, occluder, or filter.

FIELD

The disclosure relates generally to the field of expandable intraluminal medical devices. Particular embodiments relate to low profile support frames for use in such medical devices. Additional embodiments relate to prosthetic valves, stents, filters, occluders, and other intraluminal medical devices that incorporate one or more low profile support frames.

BACKGROUND

A variety of expandable intraluminal medical devices have been developed over recent years. For example, stents are routinely used in several body lumens as a means for providing support to ailing vessels, such as coronary and non-coronary vessels. Occlusion devices are used to substantially block fluid flow through a body vessel, and prosthetic valves are used to regulate fluid flow through a body vessel. Both prosthetic heart valves and venous valves have been the subject of significant development efforts in recent years.

Expandable intraluminal medical devices are typically delivered to a point of treatment using a delivery system designed for percutaneous techniques. In a conventional procedure, a caregiver navigates the delivery system through one or more body vessels until the expandable intraluminal medical device, which is typically contained in a distal tip of the delivery system, is positioned at or near the desired point of treatment. Next, the caregiver deploys the expandable intraluminal medical device from the delivery system, either by removing a constraining force for self-expandable devices or by providing an expansive force for balloon-expandable devices. Once deployment is complete, the delivery system is removed from the body vessel, leaving the intraluminal medical device in an expanded configuration at the point of treatment. This delivery and deployment technique is largely conventional and is used for most types of expandable intraluminal medical devices, including stents, occluders, valves, and other types of devices.

During delivery, expandable intraluminal medical devices are maintained in a compressed or reduced-diameter configuration within the delivery system to ensure navigability of the delivery system through the body vessel. The navigability of the delivery system is directly related to its overall outer diameter. A relatively large diameter limits the ability of a delivery system to be navigated past curves, angles, side branch openings and other impediments, and also limits the ability of a delivery system to enter and/or be navigated through small diameter vessels.

Because the delivery system must carry the intraluminal medical device to the point of treatment in the body vessel, efforts to minimize the outer diameter of delivery systems are necessarily confined by the ability of the intraluminal medical device to be compressed. The material, construction, and configuration of the medical device can limit its ability to be compressed which, in turn, limits the useable outer diameter of the delivery system that will ultimately be used with the device.

Some intraluminal medical devices, including some prosthetic valves and occluders, include graft and/or valve members that add to the bulk of the support frame included in the device, compounding the difficulty associated with increasing the compressibility of the device. A need exists, therefore, for low profile support frames that can be used in one or more such expandable intraluminal medical devices, either independently of or in conjunction with other device components. Furthermore, a need exists for a variety of intraluminal medical devices that include a low profile support frame, including prosthetic valves, stents, filters, occluders, and the like.

BRIEF SUMMARY

Low profile support frames for use as or in expandable intraluminal medical devices are described. A low profile support frame according to an exemplary embodiment comprises a first wire member having first and second ends and defining a first arcuate path with a first curve disposed between the first and second ends; a second wire member having third and fourth ends and defining a second arcuate path with a second curve disposed between the third and fourth ends; a first connector attached to the first and third ends; and a second connector attached to the second and fourth ends. The first and second wire members form a closed circumference that defines a closed cell, and the first connector is spaced from the second connector along a longitudinal axis of the support frame.

In alternate embodiments, one or more of the first and second wire members comprises a series of curves that defines a path.

Expandable intraluminal medical devices that include a low profile support frame are also described. A prosthetic valve according to an exemplary embodiment comprises a support frame providing a closed circumference defining a closed cell. The support frame includes a first wire member having first and second ends and defining a first arcuate path with a first curve disposed between the first and second ends, a second wire member having third and fourth ends and defining a second arcuate path with a second curve disposed between the third and fourth ends, a first hollow connector disposed around the first and third ends, and a second hollow connector disposed around the second and fourth ends. A valve member having first and second edges is attached to the support frame with at least a portion of the first edge attached to the support frame and the second edge being substantially free of the support frame and adapted to move between first and second positions.

A prosthetic valve according to another exemplary embodiment comprises a first wire member having first and second ends and defining a first arcuate path with a first curve disposed between the first and second ends; a second wire member having third and fourth ends and defining a second arcuate path with a second curve disposed between the third and fourth ends; a first hollow connector disposed around the first and third ends such that the first end is disposed on top of the third end with respect to a plane containing the closed circumference; a second hollow connector disposed around the second and fourth ends such that the second and fourth ends are disposed substantially side-by-side with respect to the plane containing the closed circumference; and a valve member having first and second edges, at least a portion of the first edge attached to the support frame and the second edge being substantially free of the support frame and adapted to move between first and second positions.

Additional understanding of the low profile support frames and various intraluminal medical devices can be obtained with review of the following detailed description and the appended drawings.

DETAILED DESCRIPTION

The following detailed description and appended drawings describe and illustrate various exemplary embodiments of the invention. The description and drawings serve to enable one skilled in the art to make and use the inventive apparatuses, and are not intended to limit the scope of the invention or the protection sought in any manner.

FIGS. 1,1A and1B illustrate an exemplary support frame10. The support frame10includes first12and second14wire members. The first wire member12includes a first end12aand a second end12b. The wire member12defines an arcuate path12cthat includes a curve12ddisposed substantially at a midpoint between the first12aand second12bends. Similarly, the second wire member14includes first14aand second14bends and defines an arcuate path14cthat includes a curve14ddisposed substantially at a midpoint between the ends14a,14b.

The wire members12,14cooperatively define a closed circumference16that, in turn, defines a single closed cell18. A first connector20is disposed at one end of the support frame10and a second connector22is disposed at the opposite end of the support frame10. The first ends12a,14aof the first12and second wire14members are disposed within the first connector20, and the second ends12b,14bof the first12and second14wire members are disposed in the second connector22. Each of the connectors20,22is attached to the appropriate ends12a,12b,14a,14bto maintain the closed circumference16defined by the wire members12,14. While the connectors20,22are illustrated as hollow members that receive the ends12a,12b,14a,14bof the wire members12,14, it is understood that any suitable means for connecting wire members together can be used, including mechanical connections, such as crimping, adhesives, a connection formed by annealing or brazing, or any other suitable structure that provides a means for connecting wire members. The specific structure selected for the means for connecting the wire members in a support frame according to a particular embodiment of the invention will depend on various considerations, including the materials used in the wire members12,14.

It is noted that, while the support frame10is illustrated as being formed of independent wire members connected to each other, the support frame10can be formed of a unitary piece of material using suitable techniques and materials. For example, the support frame could be cut from a tube of shape memory material using conventional or other suitable techniques. For example, the support frame could be cut from a tube of nitinol using laser cutting or other suitable techniques, followed by expansion and heat treatment steps that are known in the art. In these unitary embodiments, the wire members comprise struts in the resulting structure and the connectors20,22comprise joints at which individual struts are joined to each other. Connectors that are separate and distinct from the struts are not necessary in these embodiments—the joints perform the connecting function of the connectors in these embodiments. Also, a single wire member could be used to form the support frame using suitable bending techniques. In these embodiments, bends in the wire member eliminate the need for connectors. It is noted, though, that in these embodiments, the inclusion of one or more connectors might still be considered advantageous as a crimping force providing by the connector may maintain a bend in the single wire member in a minimal thickness. It is also noted that a single wire member having one end formed by a bend and the other end formed by attaching two independent ends of the single wire member can be used to form the support frame.

While the illustrated support frame10includes two wire members12,14, it is expressly understood that support frames can include any suitable number of wire members. It is noted, though, the inclusion of only two wire members is considered particularly advantageous at least because two wire members, either as separate wire members, struts in a unitary structure, or as a unitary wire formed into a support frame, is believed to provide the minimum structure needed to achieve the beneficial results described herein, such as the minimal nature of the overall bulk of the support frame.

In the illustrated embodiment, each connector20,22includes a closed24and an open26end. The open end26is sized and configured to receive the appropriate ends12a,12b,14a,14b. The closed end24does not provide access to the inside of the connector20,22. A barb is advantageously included on each of the connectors20,22. In this embodiment, the barb28on the first connector20is disposed on a surface of the first connector20that faces in a substantially opposite direction than the direction faced by the surface of the second connector22on which barb30is disposed, relative to a plane containing the closed circumference16defined by the wire members12,14. Also in this embodiment, the first barb28extends away from the first connector20in a direction that is different from the direction in which the second barb30extends away from the second connector22. As illustrated in the figure, the barbs28,30advantageously extend in substantially opposite directions. This configuration is expected to provide advantageous anchoring characteristics. It is noted that the barbs28,30are not necessarily drawn to scale relative to any other component and/or element of the frame10, and are shown as relatively large elements for illustrative purposes only.

As best illustrated inFIGS. 1A and 1B, pairs of the ends12a,12b,14a,14bare advantageously positioned in their respective connectors20,22such that an imaginary line I1containing the geometric centers (illustrated by dots) of ends12a,14aorients substantially orthogonally to an imaginary line I2containing the geometric centers (illustrated by dots) of ends12b,14b. Thus, when the frame10is substantially flattened into a plane, as illustrated inFIG. 1, the first ends12a,14aare disposed with one end14asubstantially on top of the other12a, relative to a plane containing the closed circumference16defined by the wire members12,14. The second ends12b,14bare disposed substantially side-by-side, relative to a plane containing the closed circumference16defined by the wire members12,14. Thus, a plane containing the geometric centers of ends12a,14ais disposed substantially orthogonal to a plane containing the geometric centers of ends12b,14b. This configuration of the ends12a,12b,14a,14bis considered advantageous at least because it aids in maintaining a desirable configuration of the closed cell18defined by the closed circumference16following deployment of the support frame10in a body vessel.

FIG. 1Cillustrates an alternate arrangement for the first pair of ends12a,14a. In this embodiment, the ends12a,14adefine complimentary semi-circular structures. This configuration minimizes the space needed within the connector20to contain the ends12a,14a, further reducing the overall bulk of the support frame. This structure also eliminates or reduces the need to fill voids within the connector20(visible inFIG. 1A) with filler material, such as solder or other material. Indeed, this structure can facilitate the use of purely mechanical means for attaching the connector20to the ends12a,14a, such as crimped connectors. In this embodiment, the entire wire members can define the complimentary shapes illustrated inFIG. 1C, or just the ends12a,14aor another longitudinal portion of the wire members can define the complimentary shapes, with the remainder of the wire members having a round or other cross-section shape. Also, whileFIG. 1Conly illustrates one pair of ends12a,14a, it is understood that one or both pairs of ends can define complimentary shapes. Furthermore, one pair of ends can define complimentary shapes, such as illustrated inFIG. 1C, while the other pair of ends has a different structure, such as illustrated inFIG. 1Aor1B. Lastly, it is understood that, whileFIG. 1Cillustrates semi-circular complimentary shapes, it is understood that any suitable set of complimentary shapes can be used, including other mating shapes, interlocking shapes, and any other suitable shapes.

The frame10can be modified to include a structural member, such as one or more of a ball, ring, hook, loop, or other suitable structural member that facilitates repositioning and/or retrieval of the frame within or from a body vessel using an appropriate catheter or other suitable device adapted to engage the structural member. The structural member can be integrally formed with the frame10or one or both connectors20,22or can comprise a separately attached member. Furthermore, the structural member can be positioned on the frame10at any suitable location. In one exemplary embodiment, a loop is formed on one connector opposite the open cell defined by the wire members. A retrieval device with a hook can then be used to engage the loop to facilitate repositioning and/or retrieval of the device.

FIG. 2illustrates the support frame10disposed within a lumen64of a body vessel60. The low profile nature of the support frame10can be seen immediately from this view. Upon deployment, the frame10adopts an expanded configuration in which the first pair of ends12a,14ais spaced from the second pair of ends12b,14bon a lengthwise axis a1of the frame10. The first pair of ends12a,14aextends in a first direction away from a structural midpoint of the support frame10along the lengthwise axis al, while the second pair of ends12b,14bextends in a second, substantially opposite direction away from the structural midpoint of the support frame10along the lengthwise axis a1. The first pair of ends12a,14aextends along an axis that is different from, but substantially parallel to, the lengthwise axis a1and the second pair of ends12b,14bextends along an axis that is different from, but substantially parallel to, both the lengthwise axis a1and the lengthwise axis of the first pair of ends12a,14a. Also, no portion of the support frame10is disposed on a transverse axis a2opposite the first pair of ends12a,14aand/or the first connector20, and no portion of the support frame10is disposed on a transverse axis a3opposite the second pair of ends12b,14band/or the second connector22. When deployed in a body vessel, as illustrated inFIG. 2, the wire members12,14, and the arcuate paths12c,14cdefined by the members12,14, are in substantially continuous contact with the inner surface of the wall62of the body vessel60. The first connector20and first pair of ends12a,14ais in contact with a portion of the wall62of the body vessel60that is substantially opposite the portion of the wall62with which the second connector22and the second pair of ends12b,14bis in contact.

As best illustrated inFIG. 2, the arcuate paths12c,14cand curves12d,14ddefined by the wire members12,14position the connectors20,22and ends12a,14a,12b,14bin this manner upon adoption of an expanded configuration and allow the support frame10to exert a desirable force on the body vessel60, such as an outwardly-directed radial force, despite the minimal nature of the structure of the support frame10. The structure of the arcuate paths12c,14cand/or the curves12d,14d, including the radius of curvature for the various portions of the wire members12,14, can be varied and indeed optimized for particular support frames intended for particular uses. For example, the illustrated support frame10may be suitable for use as a stent, as described below. An alternative support frame that positions the central portion of the arcuate path12c,14con a substantially transverse axis to the lengthwise axis al of the support frame10, upon expansion, is believed to be particularly advantageous for use in an occluder medical device that includes such a support frame. A skilled artisan will be able to determine an appropriate structure of the arcuate paths and/or curves for a support frame according to a particular embodiment based on various considerations, including the nature of the body vessel in which the support frame is intended to be deployed, the nature of fluid flow through the body vessel, and the nature and function of any additional components included in a medical device that includes the support frame.

The wire members12,14can be formed of any suitable resilient material acceptable for use in implantable medical devices. Examples of suitable materials include, but are not limited to, stainless steel, nitinol, nickel-cobalt-chromium alloys, nickel-cobalt-chromium-molybdenum alloys, polymeric materials, and other biocompatible materials. Nickel-cobalt-chromium-molybdenum alloys, such as MP35N (Carpenter Technology, Wyomissing, Pa.; MP35N is a registered trademark of SPS Technologies, Inc.), are considered particularly advantageous at least because of the relatively high tensile strength provided by these materials. As used herein, the term “wire member” does not refer to any particular size, diameter, or cross-sectional shape. While wire members having substantially circular cross-sectional shapes offer particular advantages, they are not required. Examples of other suitable cross-sectional shapes include, but are not limited to, flat, square, triangular, D-shaped, trapezoidal, and delta-shaped cross-sectional shapes. Also, as mentioned above, the support frame10can comprise a unitary member cut from an appropriate material, such as from a tube of shape memory material. In these embodiments, the wire members comprise struts in the structure resulting from the cutting process.

The connectors20,22can be formed from the same material or a different material than that of the wire members12,14. Skilled artisans will be able to select appropriate materials for use in a support frame10according to a particular embodiment of the invention based on various considerations, including the intended use, treatment environment and manufacturing demands of the support frame10. The inventors have determined that wire members12,14formed of nitinol and connectors20,22formed of stainless steel provide a support frame with desirable characteristics for use in a variety of applications, including as a component in intraluminal medical devices, such as stents, prosthetic valves, and occluders.

FIG. 3illustrates a support frame10′ according to an alternative embodiment. The frame10′ is similar to the frame10illustrated inFIG. 1, except as detailed below. Thus, the frame10′ includes first12′ and second14′ wire members. The first wire member12′ includes a first end12a′ and a second end12b′, and the second wire member14′ includes a first end14a′ and a second end14b′. The wire members12′,14′ cooperatively define a closed circumference16′ that, in turn, defines a single closed cell18′. A first connector20′ is disposed at one end of the support frame10′ and a second connector22′ is disposed at the opposite end of the support frame10′. The first ends12a′,14a′ of the first12′ and second wire14′ members are disposed within the first connector20′, and the second ends12b′,14b′ of the first12′ and second14′ wire members are disposed in the second connector22′. Each of the connectors20′,22′ is attached to the appropriate ends12a′,12b′,14a′,14b′ to maintain the closed circumference16′ defined by the wire member12′,14′.

In this embodiment, the first wire member12′ comprises a first series70a′ of curves72a′ that define a first serpentine path74a′, and the second wire member14′ comprises a second series70b′ of curves72b′ that define a second serpentine path74b′. While the frame10′ is illustrated with both wire members12′,14′ defining serpentine paths, it is understood that a frame can be constructed with only one of the wire members defining a serpentine path without departing from the scope of the invention. In these alternative embodiments, the wire member not defining a serpentine path can have any suitable configuration, including an arcuate path as described and illustrated in regards to the embodiment illustrated inFIG. 1.

The inclusion of a series of curves that define a serpentine path is considered advantageous at least because this configuration is expected to increase the radial expandability and stability of the support frame10′.

FIG. 4illustrates a support frame10″ according to another alternative embodiment. The frame10″ is similar to the frame10illustrated inFIG. 1, except as detailed below. Thus, the frame10″ includes first12″ and second14″ wire members. The first wire member12″ includes a first end12a″ and a second end12b″, and the second wire member14″ includes a first end14a″ and a second end14b″. The wire members12″,14″ cooperatively define a closed circumference16″ that, in turn, defines a single closed cell18″. A first connector20″ is disposed at one end of the support frame10″. The first ends12a″,14a″ of the first12″ and second wire14″ members are disposed within the first connector20″.

In this embodiment, the first wire member12″ comprises a first series70a″ of curves72a″ that define a first serpentine path74a″, and the second wire member14″ comprises a second series70b″ of curves72b″ that define a second serpentine path74b″. Each of the wire members12″,14″ also includes one or more curves76″ disposed along the length on an interconnecting section78″ between curves72a″,72b″ of the series70a″,70b″ of curves. The curves76″ can comprise curvilinear curves, as illustrated, angulated, or other curves, but do not comprise curves that substantially after the path of the interconnecting section78″. The inclusion of such curves is considered advantageous at least because they provide a flexing zone to the interconnecting sections78″ that allow the frame10″ to better conform to a tortuous duct or vessel. The inclusion of curves76″ is also expected to facilitate deployment of the frame10″, or an intraluminal medical device including the frame10″, from side-viewing endoscopes, which have an acute delivery angle.

While the support frames described herein are considered useful independent of additional components, as an intraluminal stent, for example, the frames are also useful as a platform onto which other components and or functionalities can be added to provide new and useful intraluminal medical devices of various types, such as stents, prosthetic valves, occluders, filters, and the like. Various examples of such devices are described below.

The inventive support frames can be used as a component in a removeable biliary stent. Current plastic biliary stents last only about six months before becoming clogged and requiring removal and/or replacement. Thus, there is a need for a stent that is less likely to become clogged. The low profile nature of the inventive support frames make them well-suited for this application. In these embodiments, the wire members of the frame advantageously can be coated and/or encased in a polymer, such as Thoralon or another suitable polymer, to prevent cells/tissue from growing over the wire members, which could hinder retrieval and/or removal of the stent. Alternatively, the stent could be used as a short term measure to dilate the duct to allow passage or removal of a larger stone or calculi such that the polymer wouldn't be necessary. The stent could even be used to capture the stone and retain it while being removed from the duct, thereby removing the stone. In placing these stents in the common bile duct (or pancreatic duct), the proximal pair of ends of the support frame would extend from the Papilla of Vater into the duct, allowing the stent to be retrieved and removed under endoscopic viewing. These stents can be delivered from a sheath or directly from the accessory channel of a duodenoscope if it is placed close enough to the papilla to limit expansion until the stent was deployed within the duct. Trigger wires or constraining sutures can be used to control expansion during deployment. The connector joining the ends of the support frame wire members that is inserted into the duct may be shaped to aid in cannulation of the papilla, or it may include a passageway to allow the stent to be introduced into the duct over a wire guide used for the cannulation of the papilla.

It is noted that, while the support frames are described as being useful in stents intended for placement in certain bodily ducts and vessels, such as the common biliary duct and other ducts of the biliary tract, the frames, and indeed the devices that include the frames, can be used in any suitable bodily duct, passage, vessel or other location in need of a benefit provided by the support frame or medical device, such as a stenting function, a valving function, an occlusion function, or any other benefit provided by the support frame or medical device as appropriate. For example, the stents described herein could be adapted for use as urethral stents without departing from the scope of the invention. Also, the prosthetic valves described herein could be adapted for use as prosthetic venous valves and prosthetic heart valves without departing from the scope of the invention.

FIG. 5illustrates an exemplary stent80positioned within a common bile duct81of an animal, such as a human. The stent80is similar to support frame10illustrated inFIG. 1, but includes first82aand second82bserpentine sections formed by bends in each of the wire members83a,83b. The first connector84is an elongate structure defining a tapered atraumatic tip which adapts the connector84for cannulation of the papilla during deployment of the biliary stent80. The second connector85includes an outwardly-extending flap86that engages the major papilla during placement, which prevents the stent80from being completely inserted into the common bile duct81during placement and aids in retrieval of the stent80. A loop87extends from the proximal end of the second connector85, providing a structure that can be engaged by a suitable catheter-based or other tool for retrieval of the stent80from the duct81.

As illustrated in the figure, the serpentine sections82a,82bcan be positioned in contact with the duct wall across a stricture88therein. This positioning is considered advantageous because it is believed that the increased radial strength in the region of the stent80that includes the serpentine sections82a,82bwill aid in maintaining the patency of the duct81at the stricture. It is noted that while the serpentine sections82a,82bare illustrated as being positioned substantially in the longitudinal middle of the stent80, they can be positioned at any point along the length of the stent80. Indeed, the serpentine sections82a,82bcan be positioned in a custom location on a stent80that is based on a known or expected location of a specific stricture within a specific duct of a specific animal. Furthermore, while two serpentine sections82a,82bare illustrated, it is noted that any suitable number of serpentine sections can be included, including a series of serpentine sections such as illustrated inFIGS. 3 and 4. Also, each wire member can include any suitable number of serpentine sections, including zero, and the wire members need not have the same number of serpentine sections.

FIGS. 6,7and7A illustrate another exemplary stent90positioned within a body vessel91of an animal, such as a human. Stent90is similar to the stent80illustrated inFIG. 5, except that the wire members do not include serpentine sections. Thus, the stent90includes a first connector92that is an elongate structure defining a tapered atraumatic tip and a second connector93that includes an outwardly-extending flap94. In this embodiment, multiple loops95extend from the proximal end of the second connector93, providing multiple structures that can be engaged by a suitable retrieval tool. The inclusion of multiple loops is considered advantageous because multiple loops provide multiple structures that can be engaged during retrieval, which is expected to increase the ease with which the stent90can be retrieved from the vessel91.

FIG. 7Aillustrates the spacing of the wire members96a,96bnear the second connector93.

FIGS. 8 and 8Aillustrate an alternative structure for stent90. In this embodiment, the stent90includes a stabilizing member96that extends along an axis that is substantially parallel to a lengthwise axis of the stent90. A proximal end of the stabilizing member97is contained within the second connector93along with the ends of the wire members96a,96b, and a distal end of the stabilizing member96is free of contact with other portions of the stent90. As illustrated in the figure, the stabilizing member97provides a structural member that extends along the wall of the duct91, providing additional contact area between the stent90and the wall. It is believed that this additional contact area will enhance the ability of the stent90to maintain patency of the duct91.

ComparingFIGS. 7A and 8Areveals a benefit of a stabilizing member that extends to the second connector93. As illustrated inFIG. 8A, a stabilizing member97positioned in this manner provides a third point of support to aid in maintaining patency of the duct or body vessel near the second connector93and proximal end of the support frame. In biliary stent embodiments, this portion of the support frame is typically positioned near the sphincter of Odii, which controls the flow of digestive juices out of the biliary tract. The inclusion of a stabilizing member positioned in this manner in a biliary stent embodiment therefore, provides a third point of contact with the sphincter and is expected to enhance drainage of the duct following placement of the stent, which may reduce the likelihood that the stent will become clogged and/or lengthen the time it takes for the stent to become clogged.

Any suitable structure can be used for the stabilizing member97, including a single wire member, a looped wired member (as illustrated inFIGS. 8 and 8A), and any other suitable structure. A looped member is considered advantageous at least because the loop can be formed to include a rounded edge, which will be less likely to engage and/or pierce the duct wall than a simple blunt end of a single wire member. Furthermore, the distal end of the stabilizing member96, no matter the structure used, can be coated or embedded within a material, such as a plastic or gel, that provides a desired atraumatic tip for the distal end.

FIG. 9illustrates an alternative stabilizing member97′. In this embodiment, the stabilizing member is connected to the wire members96a,96bat a point between the first92and second93connectors. A simple cannula or other suitable connection can be used to form this connection, or the stabilizing member97′ can be integrally formed with the wire members96a,96b. In this embodiment, the stabilizing member97′ is a loop structure that includes first98aand second98bbends that, in conjunction with the distal loop98c, define first99aand second99bs-curves. This structure is expected to provide desirable radial strength characteristics while not adding significantly to the overall bulk of the stent90.

It is noted that, while the illustrated biliary stents include a flap structure for engaging the papilla during placement, any suitable retention structure that mechanically prevents the biliary stent from being completely advanced into the biliary duct can be used, including multiple flaps, pigtails, balloons, and the like. It is also noted that, if prevention of migration at the opposite end of the stent is desired, one or more suitable retention structures can be placed on the distal end of the stent as well, either in addition to or in place of the flap or other retention structure positioned at the proximal end of the stent.

FIG. 10illustrates the stent90ofFIGS. 6 and 7placed within a delivery system101. The stent90is in a compressed configuration and circumferentially surrounded by a sheath102. The loop95is engaged with a corresponding loop103on an inner member104of the delivery system101. A guidewire105passes through exchange port106and through a passageway107defined by the first connector92, allowing the stent90to be placed using guidewire-based delivery and deployment procedures. It is noted that, while the illustrated delivery system101is adapted for rapid-exchange or short wire applications, a convention over-the-wire delivery system could also be used. In these embodiments, the second connector93can also define a passageway through which the guidewire can pass.

FIGS. 11,12,12A,13, and13A illustrate a prosthetic valve device100according to an exemplary embodiment of the invention. The prosthetic valve device100includes a support frame110and an attached valve member150. In each of the figures, the valve device is disposed within a body vessel160. The body vessel160has a wall162and defines a lumen164.

The support frame110is similar to the support frame10illustrated inFIG. 1and described above. Thus, the support frame110includes first112and second114wire members. The first wire member112includes a first end112aand a second end112b. The wire member112defines an arcuate path112cthat includes a curve112ddisposed substantially at a midpoint between the first112aand second112bends. Similarly, the second wire member114includes first114aand second114bends and defines an arcuate path114cthat includes a curve disposed substantially at a midpoint between the ends114a,114b. The wire members112,114cooperatively define a closed circumference116that, in turn, defines a single closed cell118. A first connector120is disposed at one end of the support frame110and a second connector122is disposed at the opposite end of the support frame110. The first ends112a,114aof the first112and second114wire members are disposed within the first connector120, and the second ends112b,114bof the first112and second114wire members are disposed in the second connector122.

Each of the connectors120,122is attached to the appropriate ends112a,112b,114a,114band includes a closed124and an open126end. Pairs of the ends112a,112b,114a,114bare disposed in the open end126of the appropriate connector120,124. A first barb (not illustrated inFIG. 11) is disposed on the first connector120and a second barb130on the second connector122, substantially opposite to the first barb. It is noted that the barbs are not necessarily drawn to scale relative to any other component and/or element of the frame110, and are shown as relatively large elements for illustrative purposes only.

The valve member150comprises a section of material, such as a sheet, that is attached to the support frame110. The valve member150can be formed of any suitable material, and need only be biocompatible or be able to be rendered biocompatible. The material can advantageously be formed of a flexible material. Examples of suitable materials for the valve member150include natural materials, synthetic materials, and combinations of natural and synthetic materials. Examples of suitable natural materials include extracellular matrix (ECM) materials, such as small intestine submucosa (SIS), other bioremodellable materials, and fixed natural tissues, such as fixed bovine pericardium. Other examples of ECM materials that can be used in the prosthetic valves of the invention include stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater. Tissue valves and portions thereof, such as a leaflet, patch, or other suitable portion of a tissue valve, can also be used. One or more sections of dermis, such as porcine and cadaveric dermis, can also be used as the valve member. ECM materials are particularly well-suited materials for use in the valve member150, at least because of their abilities to remodel and become incorporated into adjacent tissues. These materials can provide a scaffold onto which cellular in-growth can occur, eventually allowing the material to remodel into a structure of host cells. Examples of suitable synthetic materials include polymeric materials, such as expanded polytetrafluoroethylene and polyurethane. The use of synthetic materials also allows the valve member to be formed as a web spanning appropriate portions of the support frame110, such as by spraying, dipping or other suitable techniques for forming a webbing between structural members.

The valve member150includes a free edge152that is not attached to the support frame110and at least one portion154that is attached to the support frame by in any suitable manner, such as sutures156. Alternatively, the valve member150can be attached to the support frame110by other means for attaching, such as adhesives, a heat seal, a tissue weld joint, a weave, or any other suitable means for attaching a valve member to a portion of a support frame. The specific means for attaching chosen will depend at least upon the materials used in the valve member150and the support frame110, and a skilled artisan will be able to determine appropriate structure for a valve device according to a particular embodiment of the invention.

Alternatively, the one or both of the wire members112,114can be passed into and/or through one or more portions of the valve member150to create an attachment between the support frame110and valve member150. For example, one or both of the wire members112,114can be inserted into a thickness of a portion of the valve member150, such as an associated patch of tissue, extended along a length thereof and eventually passed back out of the thickness. This “tunneling through” a portion of the valve member may provide an attachment that eliminates the need for sutures or other attachment members, and is considered suitable for use in valve devices having valve members that provide an acceptable thickness that is able to accommodate the wire members112,114. Skilled artisans will be able to determine if this alternative attachment is suitable for any given valve member based on various considerations, including the thickness of the material of the valve member and the diameter or other relevant dimension of the wire members112,114. Valve members comprising fixed natural tissue are considered suitable for this approach. If this approach is used, the wire members112,114can be passed into and through a portion of the valve member and subsequently connected together by applying one of the connectors120,124to the wire members112,114. Also, the portion of the wire members112,114that is expected to remain within the thickness of the valve member150can include structural adaptations that enhance the attachment between the support frame110and the valve member150, such as microbarbs as described elsewhere herein.

As illustrated inFIG. 11, two lateral portions154,155of the valve member150are advantageously attached to the support frame by wrapping the edges of the valve member150around the wire members112,114. Also advantageously, the valve member150is sized and configured to extend from a point at which the wire members112,114overlap and/or touch each other to the curve112d,114dassociated with each member112,114. Extending the valve member150to this length is expected to enhance the durability of the attachment between the valve member150and the support frame110under dynamic in vivo conditions. Alternatively, the valve member150can be sized and configured to extend from a point at which the wire members112,114overlap and/or touch each other to a point beyond the curve112d,114dassociated with each member112,114.

As described in more detail below, the free edge152is moveable between first and second positions when the device100is placed within a body vessel. The valve member150includes slack158between the wire member112,114that facilitates this movement of the free edge152.

The prosthetic valve device100is adapted to be disposed in a body vessel160using percutaneous delivery techniques. The body vessel160can be any suitable body vessel, including any vessel of the vasculature, such as veins, arteries, and sections of the heart. Thus, the vessel160illustrated in the figures is illustrative only; the basic structure should not be interpreted as limiting the types of vessels in which the device can be deployed. As such, the vessel160includes a vessel wall162and defines a lumen164in which the valve device100is disposed.

FIGS. 12 and 12Aillustrate the valve device100in a closed configuration whileFIGS. 13 and 13Aillustrate the valve device100in an open configuration. The valve device100is secured in the body vessel by the first barb128, which passes into the vessel wall162at a first point166, and the second barb130, which passes into the vessel wall162at a second point168. It is noted that the barbs128,130are not necessarily drawn to scale. Indeed, microbarbs that only partially pass into the thickness of the vessel wall162may be used. Furthermore, a series of two or more microbarbs can be used at each barb128,130location. The barbs128,130are illustrated as penetrating through the entire thickness of the vessel wall only to facilitate understanding of the operation of the valve device100and is not required. Furthermore, a series of two or more microbarbs can be used at each barb128,130location.

Also, the barbs128,130can have shape memory properties of their own that facilitate anchoring of the valve device100in the body vessel. For example, the barbs128,130can adopt an “open” configuration at room temperature and a “clamped” or “closed” configuration at another temperature, such as the expected or actual body temperature of the animal, such as a human, into which the valve device is being implanted. In the open configuration, a clearance exists between the barb and the underlying connector120,122and/or wire member112,114. In the clamped or closed configuration, the clearance is reduced. Thus, when the transition temperature is reached, the barb128,130moves closer to the connector120,122and/or wire member112,114, which can clamp a portion of the vessel wall162between the barb128,130and the connector120,122and/or wire member112,114. This is expected to enhance anchoring of the valve device100in the body vessel160.

As described above, the valve member150is moveable between first and second positions when the device100is placed within a body vessel160. In the first position, illustrated inFIG. 12, the valve member150substantially prevents fluid flow in the direction represented by arrow185from flowing past the point in the body vessel160at which the valve device100is deployed. In the second position, illustrated inFIG. 13, the valve member150permits fluid flow in an opposite direction, represented by arrow175, to flow through the closed cell118defined by the closed circumference116. The valve member150moves to the first position when a pressure change and/or reversal of flow direction exerts a force on an edge or face of the valve member150and forces it away from the vessel wall162and across the lumen164of the vessel160. The valve member150moves to the second position when a pressure change and/or reversal of flow direction exerts a force on an opposing edge or face of the valve member150, forcing it toward vessel wall161. The first position of the valve member150can be considered a closed position, and the second position can be considered an open position. By moving between these two positions, the valve member150provides a valving function to the medical device100, allowing it to regulate fluid flow through the body vessel160.

As illustrated inFIGS. 12 and 12A, the valve member forms a pocket159that collects fluid, substantially preventing passage through the closed cell118defined by the closed circumference116during periods of retrograde flow in which the valve member150is in the closed position. As best illustrated inFIGS. 13 and 13A, the valve member150is forced toward a portion of the vessel wall162(upward in the Figure) during periods of antegrade flow175, thereby adopting the open position and allowing fluid to flow through the closed cell118defined by the closed circumference116.

The medical device100illustrated inFIGS. 11 through 13is a prosthetic valve, and can be used as a prosthetic venous valve. In this capacity, the device100is placed in a vein to regulate the flow of blood through the vein. It is believed that the valve member150moves to the open position, illustrated inFIG. 13, during systole in which the heart forces blood through the vein in the first direction175. During diastole, the valve member150moves to the closed position, illustrated inFIG. 12, to substantially prevent fluid flow in the second, opposite direction185. It is believed that a pressure change and reversal of flow direction occurs during the change from systole to diastole, and the valve member150changes position in response to these changes. Flow in the second, opposite direction185is commonly referred to as retrograde flow.

The valve member150substantially, but not entirely, prevents fluid flow in the second, opposite direction185for at least two reasons. First, as the valve member150moves from the first position to the second position, a time period passes before the valve member is in the second position, and some retrograde flow may pass through the device100during this time. Second, as best illustrated inFIGS. 12 and 12A, the valve member150does not form a complete and constant seal with the vessel wall162while in the second or closed position.

FIG. 14illustrates a support frame210according another exemplary embodiment of the invention. The support frame210according to this embodiment is similar to the support frame10illustrated inFIG. 1and described above, except as detailed below. Thus, the support frame210includes first212and second214wire members. The first wire member212includes a first end212aand a second end212b. The wire member212defines an arcuate path212cthat includes a curve212ddisposed substantially at a midpoint between the first212aand second212bends. Similarly, the second wire member214includes first214aand second214bends and defines an arcuate path214cthat includes a curve disposed substantially at a midpoint between the ends214a,214b. The wire members212,214cooperatively define a closed circumference216that, in turn, defines a single closed cell218. A first connector220is disposed at one end of the support frame210and a second connector222is disposed at the opposite end of the support frame210. The first ends212a,214aof the first212and second214wire members are disposed within the first connector220, and the second ends212b,214bof the first212and second214wire members are disposed in the second connector222.

Each of the connectors220,222is attached to the appropriate ends212a,212b,214a,214band includes a closed224and an open226end. Pairs of the ends212a,212b,214a,214bare disposed in the open end226of the appropriate connector220,224. A first barb (not illustrated inFIG. 14) is disposed on the first connector220and a second barb230on the second connector222, substantially opposite to the first barb. It is noted that the barbs are not necessarily drawn to scale relative to any other component and/or element of the frame210, and are shown as relatively large elements for illustrative purposes only.

The support frame210according to this exemplary embodiment includes first240and second242support arms. The support arms240,242provide additional surface area to the support frame210that can provide additional contact area between the support frame210and a wall of a vessel in which the frame210or an associated device is deployed. Furthermore, each of the support arms240,242defines a loop that can be engaged by another medical device, such as a retrieval hook or other device adapted to engage one or both of the arms240,242, to enable repositioning and/or retrieval of the support frame210, or a medical device that includes the support frame210, following deployment.

Each of the support arms240,242is attached to the respective wire member212,214. Alternatively, one or both of the support arms240,242can be integrally formed by the respective wire member212,214.

The first support arm240is a closed circumference243adefined by first244aand second245alengths that extend away from the first wire member212and a curve246adisposed between the first244aand second245blengths. The closed circumference243adefines an opening247abetween the first244aand second245alengths and the curve246a.

The second support arm242is a closed circumference243bdefined by first244band second245blengths that extend away from the second wire member214and a curve246bdisposed between the first244band second245blengths. The closed circumference243bdefines an opening247bbetween the first244band second245blengths and the curve246b.

FIGS. 15 through 17illustrate a valve device300according to another exemplary embodiment of the invention. The valve device300of this embodiment is similar to the valve device100illustrated inFIG. 11and described above, except as detailed below. In each of the figures, the valve device is disposed within a body vessel360. The body vessel360has a wall362and defines a lumen364.

The valve device300according to this embodiment includes a support frame310similar to the support frame210illustrated inFIG. 14and described above, and an attached valve member350. The support frame310includes first312and second314wire members. The first wire member312includes a first end312aand a second end312b. The wire member312defines an arcuate path312cthat includes a curve312ddisposed substantially at a midpoint between the first312aand second312bends. Similarly, the second wire member314includes first314aand second314bends and defines an arcuate path314cthat includes a curve disposed substantially at a midpoint between the ends314a,314b. The wire members312,314cooperatively define a closed circumference316that, in turn, defines a single closed cell318. A first connector320is disposed at one end of the support frame310and a second connector322is disposed at the opposite end of the support frame310. The first ends312a,314aof the first312and second314wire members are disposed within the first connector320, and the second ends312b,314bof the first312and second314wire members are disposed in the second connector322.

Each of the connectors320,322is attached to the appropriate ends312a,312b,314a,314band includes a closed324and an open326end. Pairs of the ends312a,312b,314a,314bare disposed in the open end326of the appropriate connector320,324. A first barb (not illustrated inFIG. 15) is disposed on the first connector320and a second barb330on the second connector322, substantially opposite to the first barb. It is noted that the barbs are not necessarily drawn to scale relative to any other component and/or element of the frame310, and are shown as relatively large elements for illustrative purposes only.

The support frame310includes first340and second342support arms attached to or formed by the respective wire member312,314. The first support arm340is a closed circumference343adefined by first344aand second345alengths that extend away from the first wire member312and a curve346adisposed between the first344aand second345blengths. The closed circumference343adefines an opening347abetween the first344aand second345alengths and the curve346a.

The second support arm342is a closed circumference343bdefined by first344band second345blengths that extend away from the second wire member314and a curve346bdisposed between the first344band second345blengths. The closed circumference343bdefines an opening347bbetween the first344band second345blengths and the curve346b.

The valve member350includes a free edge352that is not attached to the support frame310and at least one portion354that is attached to the support frame310in any suitable manner, such as sutures356. Preferably, as illustrated in the figures, the valve member350is attached to the support frame along attachment pathways defined by the first340and second342support arms. The free edge352is moveable between first and second positions when the device300is placed within a body vessel. The valve member350can include slack between the wire member312,314that facilitates this movement of the free edge352.

The prosthetic valve device300is adapted to be disposed in a body vessel360using percutaneous delivery techniques. The vessel360includes a vessel wall362and defines a lumen364in which the valve device300is disposed.FIG. 16illustrates the valve device300in a closed configuration andFIG. 17illustrates the valve device300in an open configuration. The valve device300is secured in the body vessel360by the first barb328, which passes through the vessel wall362at a first point366, and the second barb330, which passes through the vessel wall362at a second point368.

The valve member350moves between the first and second positions similar to the manner in which the valve member150illustrated inFIGS. 12 and 13does so. In this embodiment, though, the support arms340,342limit the movement the valve member can make toward the vessel wall when the valve member350moves to the second position. Furthermore, the support arms340,342provide support to the valve pocket when the valve member350is in the open position, which is expected to aid in prevention eversion of and/or damage to the valve member350.

FIG. 20illustrates an occluder400according to an embodiment of the invention. The occluder400includes a support frame410according to an embodiment of the invention and a graft member490attached to the support frame410.

The support frame410is similar to the support frame10illustrated inFIG. 1and described above. Thus, the support frame410includes first412and second414wire members. The first wire member412includes a first end412aand a second end412b. The wire member412defines an arcuate path412cthat includes a curve412ddisposed substantially at a midpoint between the first412aand second412bends. Similarly, the second wire member414includes first414aand second414bends and defines an arcuate path414cthat includes a curve414ddisposed substantially at a midpoint between the ends414a,414b. The wire members412,414cooperatively define a closed circumference416that, in turn, defines a single closed cell418. A first connector420is disposed at one end of the support frame410and a second connector422is disposed at the opposite end of the support frame410. The first ends412a,414aof the first412and second414wire members are disposed within the first connector420, and the second ends412b,414bof the first412and second414wire members are disposed in the second connector422.

Each of the connectors420,422is attached to the appropriate ends412a,412b,414a,414band includes a closed424and an open426end. Pairs of the ends412a,412b,414a,414bare disposed in the open end426of the appropriate connector420,424. A first barb (not illustrated inFIG. 20) is disposed on the first connector420and a second barb430on the second connector422, substantially opposite to the first barb. It is noted that the barbs are not necessarily drawn to scale relative to any other component and/or element of the frame410, and are shown as relatively large elements for illustrative purposes only.

The graft member490is similar in construction to the valve member described in the various valve device embodiments described above, except that the graft member490is attached to the support frame410in a manner that substantially closes the open cell418defined by the closed circumference416. Thus, the edge492of the graft member490is attached to the support frame410around substantially the entire closed circumference416. Similar to the valve embodiment, sutures494or other suitable means for attaching a graft member to a support frame can be used to form the desired attachment.

As a result of the closing of the open cell418, the occluder400, when deployed in a body vessel, can substantially block fluid flow through the body vessel at the point of deployment. This effect may be desirable in various clinical situations, including the treatment of tumors, arteriovenous malformations (AVM's), and other situations in which it is desirable to block the flow of blood or other fluid to a particular site.

FIGS. 18 and 19illustrate another exemplary valve device500. The valve device500of this embodiment is similar to the valve device300illustrated inFIGS. 15 through 17and described above, except as detailed below.

The valve device500according to this embodiment includes a support frame510and an attached bioprosthetic valve550. The support frame510includes first512and second514wire members. The first wire member512includes a first end512aand a second end512b. The wire member512defines an arcuate path that includes a curve disposed substantially at a midpoint between the first512aand second512bends. Similarly, the second wire member514includes first514aand second514bends and defines an arcuate path that includes a curve disposed substantially at a midpoint between the ends514a,514b. The wire members512,514cooperatively define a closed circumference516that, in turn, defines a single closed cell518.

The wire members512,514of the support frame510comprise a unitary structure that has been cut from a tube, such as from a nitinol tube. Thus, the support frame510lacks the connectors described above and, instead, the wire members512,514simply meet and join at their respective ends. A first plurality of barbs528is disposed at a first end of the support frame510, and a second plurality of barbs530is disposed at a second end of the support frame. As illustrated in the Figure, the each barb of the plurality of barbs528,530is advantageously adapted to pass into a partial thickness of a wall562of a body vessel560in which the valve device500is deployed.

The support frame510includes first540and second542support arms defined by the respective wire member512,514. In this embodiment, each of the support arms540,542is an open curve that defines a partial, elongated loop in the respective wire member512,514of the support frame510.

The bioprosthetic valve can comprise any suitable bioprosthetic valve, and the specific bioprosthetic valve selected for a valve device according to a particular embodiment will depend on various considerations, including the body vessel into which the valve device is intended to be implanted. Examples of suitable bioprosthetic valves include those describe in U.S. Provisional Application Ser. No. 60/980,770, which is hereby incorporated into this disclosure in its entirety. The bioprosthetic valve550is similar to the bioprosthetic valves described therein, and will be described herein only briefly. The bioprosthetic valve550includes a patch552of tissue connected to a single leaflet554. The leaflet554has a free edge556that moves in response to differing pressures in the body vessel560, or other suitable environmental changes, to open and close the valve device500and to selectively permit antegrade fluid flow, represented by arrow575inFIG. 13, and substantially prevent retrograde fluid flow, represented by arrow585inFIG. 14, through the body vessel560.

While tissue valves and sheet form valve members can be used with the support frames according to the disclosure, the support frame510illustrated inFIGS. 18 and 19is particularly well-suited for use with single leaflet bioprosthetic valves, such as the bioprosthetic valve550illustrated inFIGS. 18 and 19, at least because of the curvilinear attachment pathway provided by the arms540,542, which provides a pocket definition function believed to be critical for the formation of a functional valve from a single leaflet-containing bioprosthetic valve.

The bioprosthetic valve550is attached to one end of the support frame510, using sutures or any other suitable means for attaching tissue to a support frame. The leaflet554is advantageously attached to the wire members512,514along an attachment pathway that extends along substantially the entire length of the open curve defined by the arms540,542, although shorter and longer attachment pathways can be used. As illustrated inFIGS. 18 and 19, this produces a curvilinear attachment pathway570. Also as illustrated inFIGS. 18 and 19, it is considered particularly advantageous for the attachment pathway to include the apex572of the curves defined by the arms540,542, as this is expected to increase the overall ruggedness of the attachment between the leaflet554and the frame510in the dynamic environment of a body vessel560. Examples of other suitable means for attaching a tissue valve and/or a tissue to a support frame include clips, staples, adhesives, and tissue welding materials and techniques. As best illustrated inFIG. 19, the free edge556of the leaflet554is substantially free of the support frame510and extends between the arms540,542, allowing the free edge556to move within the confines of the wire members512,514to effect opening and closing of the valve device500.

Any suitable tissue can be used to form a bioprosthetic valve for use in a valve device according to an embodiment of the invention. The tissue selected for a bioprosthetic valve in a device according to a particular embodiment of the invention need only be capable of being attached to the support frame in a manner that forms the desired valve configuration. The tissue should be selected to provide desirable behavior of the valve following deployment of the biomedical valve device in a body vessel. Examples of suitable tissues include pleura, such as a lining from the peritoneal cavity, a tissue capsule, such as a renal capsule, and a vessel wall or portion thereof. The use of tissues other than vessel walls might be particularly advantageous when fashioning a biomedical valve device according to an embodiment of the invention that is intended to be implanted in a patient that is missing a particular body vessel or has a damaged portion of a particular body vessel. For example, in humans that have already lost a greater saphenous or other donor vessel, use of a renal capsule or other tissue might be advantageous.

FIG. 18illustrates the valve device500in a closed configuration, in which the leaflet554has substantially opened to define a valve pocket558between the leaflet554and patch552that substantially prevents retrograde fluid flow, represented by arrow585, from passing through the body vessel560. The leaflet free edge556has been forced outwardly by retrograde fluid flow585, substantially forcing the free edge556away from the patch552and allowing the valve pocket558to open. Over time, the valve pocket558fills with fluid until antegrage fluid flow or other forces, such as a change in the pressure differential across the valve device500, favors a transition to the open configuration, as illustrated inFIG. 18and described above.

FIG. 19illustrates the valve device500in an open configuration, in which the free edge556of the leaflet554has been forced inward by antegrade fluid flow575, which substantially forces portions of the leaflet554toward the patch552. The free edge556folds upon itself and/or other portions of the leaflet554when the valve device500is in this configuration, substantially reducing the volume of the valve pocket558defined by the leaflet554and patch552. In addition to the folding action of the leaflet, an elastic transition may take place prior to, during, and/or after the leaflet folds inward. With a bioprosthetic valve, it is believed that the leaflet elastically contracts to a certain point, and subsequently folds inward. When the valve device transitions to the open configuration from a closed configuration, described below with reference toFIG. 19, fluid is substantially forced out of the valve pocket558, effectively flushing the valve device500.

A comparison of the valve device500illustrated inFIGS. 18 and 19to the valve device300illustrated inFIGS. 16 and 17illustrates different functions for the support arms in the two devices. In valve device300, arms340,342effectively provide a backstop for the valve member350as it moves to the closed configuration, which may assist in the prevention of prolapse of the valve device300. In valve device500, the arms540,542include the additional function of assisting in the defining of the valve pocket558. As illustrated inFIGS. 18 and 19, the arms540,542define the lateral boundaries of the valve pocket558in both the open and closed configurations.

FIG. 21illustrates a support device600according to an exemplary embodiment of the invention. The support device600comprises a support frame610that includes first610aand second610bframe portions. Each frame portion610a,610bis similar to the support frame10illustrated inFIG. 1and described above. Thus, the first frame portion610aincludes first612aand second612bwire members connected to each other at opposing ends with connectors620a,620b. Similarly, the second frame portion612bincludes first614aand second614bwire members connected to each other at opposing ends with connectors622a,622b.

The first wire member612aof the first frame portion610aand the first wire member614aof the second frame portion610bintersect at intersection616a. Similarly, the second wire member612bof the first frame portion610aand the second wire member614bof the second frame portion610bintersect at intersection616b. The intersections616a,616bcan be a simple crossing of wire members, with optional contact between the members, or can comprise a mechanical connection between the members formed using any suitable means for connecting portions of support frame to each other, including rivets, welds, post and hole connections, and other suitable structures. A connection that allows the relevant wire members to move relative to each other at the intersection616a,616bis considered advantageous at least because it is expected to allow the support device600to flex in response to movement of a the wall662of a body vessel660in which the device is implanted.

The support device600can be used as a stent to provide intraluminal support to a body vessel. Alternatively, as described more fully below, the support device600can be used in a valve device or other suitable medical device.

FIG. 22illustrates a valve device700according to an exemplary embodiment of the invention. The valve device700includes a support frame710and an attached bioprosthetic valve750. The valve750opens and closes to regulate fluid flow through a body vessel760in which the device700is implanted.

The support frame710is similar to the support frame610illustrated inFIG. 12and described above. Thus, the support frame710includes first710aand second710bframe portions. The first frame portion710aincludes first712aand second712bwire members connected to each other at opposing ends with connectors720a,720b. Similarly, the second frame portion712bincludes first714aand second714bwire members connected to each other at opposing ends with connectors722a,722b.

The first wire member712aof the first frame portion710aand the first wire member714aof the second frame portion710bintersect at intersection716a. Similarly, the second wire member712bof the first frame portion710aand the second wire member714bof the second frame portion710bintersect at intersection716b.

The bioprosthetic valve750includes a patch752of tissue connected to a single leaflet754. The leaflet754has a free edge756that moves in response to differing pressures in the body vessel760, or other suitable environmental changes, to regulate fluid flow through the body vessel760.

The bioprosthetic valve750is attached to the support frame710at one end of the support frame710, using sutures or any other suitable means for attaching tissue to a support frame. The leaflet754is substantially free of the support frame710, allowing the free edge756to move within the confines of the wire members712,714.

As described above with reference toFIGS. 11 through 13and15through17, support frames according to the disclosure provide a suitable frame onto which a simple valve member, such as a sheet of material, can be attached to form a functional prosthetic valve. Also, as described above with reference toFIGS. 18 and 19, support frames according to the disclosure provide a suitable frame onto which more complex valve members, such as a natural valve harvested from an animal or human, can be attached to form a functional prosthetic valve device. Furthermore, as illustrated inFIG. 20and described above, the support frames according to the disclosure can be used in other types of medical devices as well, such as occluders. As such, the support frames according to the disclosure provide a relatively simple platform onto which a variety of valve members and other additional elements can be attached to form a wide array of useful medical devices.

While various embodiments are described with reference to specific features of particular drawings, it is understood that the various elements and/or features described herein in connection with one particular embodiment can be combined with those of another without departing from the scope of the invention. For example, the arms340,342of the support frame illustrated inFIG. 15could be incorporated into the support frame410of the occluder device400illustrated inFIG. 20.

The embodiments described and illustrated herein provide examples of the invention, and are not intended to limit the scope of the invention in any manner. Rather, they serve only to aid those skilled in the art to make and use the invention.