The present disclosure generally concerns medical devices, deployment mechanisms, and methods for deploying such medical devices. More specifically, the disclosure relates to surgical replacement of heart valves that have malformations and/or dysfunctions. Embodiments of the invention relate to holders for facilitating the implantation of prosthetic heart valves at such native heart valves sites, for example, for a mitral valve replacement procedure. Embodiments of the invention also relate to methods of using the holders to facilitate implantation of prosthetic heart valves.
Referring first to
Each of the valves associated with the chambers of the heart are one-way valves that have leaflets to control the directional flow of the blood through the heart, and to prevent backflow of the blood into other chambers or blood vessels that are upstream of the particular chamber. The valves are each supported by an annulus having a dense fibrous ring attached either directly or indirectly to the atrial or ventricular muscle fibers. When a valve become diseased or damaged, leakage or regurgitation may occur, where some of the blood travels back upstream through the diseased or damaged valve, and the efficiency and/or general functionality of the heart may be compromised.
Various surgical techniques can be performed to repair or replace a diseased or damaged valve. In some valve replacement procedures, the leaflets of the diseased or damaged native valve are first removed to prepare the valve annulus for receiving the prosthetic valve.
When implanting a tissue type prosthetic valve as described above at a native valve annulus, a number of sutures may be involved in the attachment process, many of which may be pre-installed for providing a track on which the valve is advanced along, or “parachuted” down, until it is properly positioned at the implant site. Additional attachment sutures may also be applied between the prosthetic valve and the heart walls after proper placement, to securely attach or hold the valve implant in place. Meanwhile, in some cases, the prosthetic valves are implanted through small access channels using one of various minimally invasive surgical procedures, where visibility at the implant site may be impeded or obstructed. In addition, depending on the direction of implantation, for example, with some mitral valve replacement procedures, commissure posts of the stent or frame, or other portions of the prosthetic valve may be pointed distally and located on a blind side of the valve.
Each of the above factors may lead to tangling of the pre-installed sutures with the valve prosthesis, most commonly with the commissure posts of the frame, since they provide a protrusion on which the sutures can easily loop around and tangle. This type of entanglement of sutures with prosthetic valves is referred to as “suture looping,” which specifically refers to instances where a pre-installed suture is inadvertently wrapped around one or more of the commissure post tips, where it can then migrate towards and damage the leaflets or interfere with proper leaflet coaptation or other valve operation when the sutures are tightened or secured, resulting in improper valve operation. In some cases, such tangling may not be apparent to the practitioner at the time of implantation, and will only be revealed some time later when valve operation is observed to be improper or other complications arise in the patient, in which case, it may be necessary to initiate another procedure to repair or replace the prosthetic valve.
Attempts have been made to resolve the problem of suture looping, some of which revolve around the holders which hold the prosthetic valves when they are delivered to the native valve annulus. In one example, a holder has a mechanism that urges the commissure posts of the prosthetic valve radially inward during delivery, so that the ends of the commissure posts are pointed inwards, to reduce the possibility of sutures catching against or looping around them. After the valve prosthesis is delivered to the implant site, the holder is removed, releasing and expanding the commissure posts to their original positions. However, although the commissure posts are biased inwardly during delivery, since the ends of the commissure posts remain free, these holders have not been fully effective in eliminating instances of suture looping.
Meanwhile, Edwards Lifesciences has developed another valve holder system, known as Tricentrix®, specifically for use in mitral valve replacement procedures to protect the valve from suture looping during valve implantation. The system includes monofilament deflection sutures that attach to both the holder and pairs of commissures of the prosthetic valve, so that the sutures run across the outflow end of the valve between the ends of the commissures. When the holder is actuated, a central post extends distally through the prosthetic valve between the leaflets and pushes against the sutures in the middle of the valve between the commissures, pushing the sutures distally and causing an angled tent-like or umbrella shape of sutures. The pressure on the sutures deflects the commissures slightly inward, while also forming the angled umbrella shape of the sutures that slope outwardly and downwardly from the central post to the commissure posts. These angled surfaces deflect away from the prosthetic valve any other sutures, such as the pre-installed attachment sutures, mentioned above, that might otherwise engage and be looped around a commissure or valve leaflet.
Other holders have also been developed in an attempt to further reduce instances of suture looping. However, some of these holders are very complex, for example, incorporating various rotary and advancement mechanisms in addition to the original hold and release mechanisms, such that a number of additional steps must be taken by the practitioner to operate the holders correctly. Many of these holders have proven to be too complicated and/or prone to user error, such as a failure to execute all deployment steps in the correct order. Consequently, when practitioners use these holders improperly, suture looping can still occur, while the implant process may also be further complicated by issues arising from user error.
In addition to the above, many of the newer holder designs also incorporate many additional parts that interact with one another or that must be assembled by the practitioner or other end user, which may also lead to additional complications. For example, where additional parts must be threaded into one another, cross-threading can occur when the threads of the various parts are inadvertently misaligned. This and/or other interactions between the additional parts may lead to increased possibility of the holder being damaged or breaking, and of loose fragments being generated.
Features of the invention provide for new holder systems and methods of using the holder systems, which reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valves during implantation. Operation of the holders is also simplified, where the additional features of the holders can be pre-deployed or integrated for deployment or actuation automatically when performing existing steps already well-known by users, thereby reducing or eliminating mistakes caused by user error and increasing patient safety. The holders can also have a reduced number of parts and/or provide for integrated alignment features or other safety features, so that cross-threading or other damaging interactions between parts can also be prevented. These holders can also be made at similar or reduced costs compared to existing holders. In addition, reducing the number of deployment steps reduces the time to complete the surgical procedure, and reduces the complexity of training, or retraining, needed to learn the procedure.
In one embodiment of the invention, a prosthetic heart valve holder system includes a prosthetic heart valve having an inflow end and an outflow end and a flow axis therethrough. The heart valve further has a base at the inflow end, a plurality of commissure posts extending from the base toward the outflow end and circumferentially spaced around the flow axis, and valve leaflets secured to the commissure posts to permit flow through the heart valve, each commissure post having a tip at the outflow end. The valve holder system further includes a deflector at the outflow end having a central hub and a plurality of arms extending from the central hub. A first end of each of the arms are secured to the central hub and a second end of each of the arms are secured to and cover a tip of a respective commissure post of the plurality of commissure posts. A valve support body is secured to the base at the inflow end and a post extends from the valve support body at the inflow end of the heart valve, through the valve leaflets, to the hub of the deflector at the outflow end. The plurality of arms of the deflector are sufficiently collapsible such that, in a first position, the second end of each of the plurality of arms is located axially between the hub and the valve support body such that the deflector prevents suture looping during an implant procedure. In a second position, the hub is located axially between the second end of each of the plurality of arms of the deflector and the valve support body to permit removal of the deflector from the outflow side of the valve, through the valve leaflets, to the inflow side of the valve without damaging the valve leaflets after detachment of the deflector arms from the tips of the commissures.
In a preferred embodiment of the prosthetic heart valve system, the plurality of commissures posts is at least three commissure posts and the plurality of arms of the deflector is at least three arms. In other embodiments, the post is a solid pin and the post may be molded or press-fit to the deflector. In a further embodiment, the deflector and the valve support may be permanently fixed a first distance apart from one another by the post. The prosthetic heart valve, the deflector and the valve support body may also be mounted in a package in the first position.
In a further preferred embodiment of the invention, the deflector is a monolithic body of flexible material. The flexible material preferably has a durometer in the range of Shore A30 to Shore A70. In an alternative embodiment, each of the plurality of arms has a transversely extending notch that forms a living hinge. In other embodiments, a layer of material that is resistant to viscoelastic stress relaxation, such as a layer of cloth, is embedded in or overmolded to the arms of the deflector. Preferably the plurality of arms of the deflector are held taut between the central hub and the plurality of commissure posts. In another embodiment, the second end of each arm is a channel member that extends over the top and three sides of the tip of the respective commissure post.
In a further embodiment, the prosthetic heart valve holder system includes an adaptor configured to be detachably connected to the valve support body on an opposite side of the valve support body from the deflector. The adaptor can be detachably connected to the valve support body by a suture.
A plurality of additional sutures can be routed from the opposite side of the valve support body, through respective commissure posts to the tips of the commissure posts, through respective deflector arms, back to the tips and back down the commissure posts, through the valve support body again and fixed to the opposite side of the valve support body. In a preferred embodiment, each of the plurality of additional sutures has a portion that is placed over a gap on the opposite side of the valve support body to permit the portions to be all cut in a single action. The adaptor may include a suture shield mounted over the gap to protect the suture portions from premature cutting until the adapter is detached from the valve support body. A handle may also be detachably connectable to the adaptor from the opposite side of the valve support body from the deflector.
In another alternative embodiment, a prosthetic heart valve holder includes a deflector having a central hub and a plurality of arms extending from the central hub, each of the plurality of arms having a first end secured to the central hub and a free second end radially outward from the hub, the valve holder further includes a valve support body and a post extending from the valve support body to the hub of the deflector. The plurality of arms of the deflector are sufficiently collapsible such that, in a first position, the second end of each of the plurality of arms is located axially between the hub and the valve support body, and in a second position, the hub is located axially between the second end of each of the plurality of arms of the deflector and the valve support body.
In a further embodiment, the plurality of arms of the deflector are sufficiently collapsible such that, in a first position, the hub is a first axial distance from the valve support body and the second end of each of the plurality of arms extends an axial distance less than the first axial distance from the valve support body and in a second position, the second end of each of the plurality of arms of the deflector is at an axial distance greater than the first axial distance.
According to embodiments of the invention, holders for prosthetic valve delivery reduce or eliminate occurrences of suture looping and/or other damage to the valves when the valves are implanted, while the mechanisms for deploying these features are integrated into the holders in a way that make it easier for end users to use and deploy.
Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings:
Disclosed herein are various valve holders for assisting in the delivery and implantation of prosthetic heart valves at an implant site, and methods for preparing the prosthetic heart valves for such procedures. Embodiments of the valve holders reduce occurrences of various complications that may arise during implantation, while remaining simple for end users to use. By providing these improved valve holders, damage to the prosthetic valves during surgical procedures can be reduced, and additional costs for extended or additional procedures and replacement valves can be avoided.
The valve holders disclosed herein are particularly useful for avoiding suture looping and other valve damage during advancement of the prosthetic valves to the implant sites as well as during final suturing of the valves at the native valve annulus. In procedures where commissure posts of the prosthetic valve point distally, for example, in many mitral valve replacement procedures, the commissure posts point in the direction of valve advancement and may be more prone to suture looping or other entangling. In these cases, valve holders according to embodiments of the invention provide deflectors that deflect the pre-installed sutures away from the prosthetic valve. In some embodiments, the valve holder system has a deflector that is pre-deployed without requiring any action by the surgeon or operating room staff and is ready for delivery to the native valve annulus upon removal of the packaging. Upon securement of the prosthetic heart valve to the annulus, the deflector is collapsible to permit it to be pulled through the leaflets without causing any damage when the holder is removed from the prosthetic valve. In other embodiments, the surgeon or operating room staff may effect automatic deployment or actuation of the respective valve holders to their deployed positions, using steps that are already associated with handling of existing valve holders. As with the pre-deployed system, upon securement of the prosthetic heart valve to the native valve annulus, the deflector is collapsible to permit it to be pulled through the leaflets without causing any damage when the holder is removed from the prosthetic valve. In this fashion, ease of use of the below described valve holders can be maintained, while user error can be minimized.
With reference to
With reference to
Preferred materials for the deflector are rubber, such as a soft silicone rubber, a soft flexible polymer, or other materials having a durometer in the range of Shore A30-A70, or preferably about Shore A50.
Additionally, the deflector may be overmolded with a cloth, fabric or other thin mesh material to give the arms strength and resistance to viscoelastic stress relaxation, yet maintain the flexibility of the deflector to permit removal through the valve leaflets. The cloth, fabric or mesh may be a single piece embedded in the deflector across the central hub and the three arms or may be multiple pieces.
The central hub 130 of the deflector has a smooth convexly curved top surface 134, a cylindrical side surface 136, and a truncated conical bottom surface 138 that narrows in a direction away from the top surface. The curved top surface 134 is for deflecting away from the leaflets any pre-installed attachment sutures during installation of the prosthetic valve. The conical bottom surface 138 provides a tapered surface to gradually spread the leaflets during retraction and removal of the deflector through the leaflets after the valve has been attached. At the truncated tip of the conical bottom surface, an opening to a bore 142 is provided for receipt of one end of the post 114.
Extending radially and downwardly away from the central hub 130 are the three arms 132. One end of each arm is secured to the cylindrical side surface of 136 of the central hub. The other end of each arm is configured to mount over a tip 6 of a respective commissure post 4 of the prosthetic valve (see
To improve the connection between the arms 132 of the deflector 112 and the commissure posts 4, the radially outer end portion of each arm forms a channel member 150 that extends down from the end of each arm. The channel member 150 has an end wall 152 and two side flanges 154 extending radially inward from the end wall to form a channel 156 to receive a tip 6 of a commissure post 4. The end wall 152 of each channel member is thickened and includes two suture holes 158 extending through the end wall into the channel 156. Preferably, the end wall of the deflector is wider than the width of the tip of the commissure post and the side flanges cover a substantial portion of the sides of the tip so as to surround the top and outside of the tip, thereby offering excellent protection against suture looping.
To improve the flexibility of the arms of the deflector, the width (w) of each arm, measured across the top surface of the arm, is gradually tapered or narrowed beginning from a location near the channel member 150 of the arm to a location near the central hub 130.
With reference to
Projecting up from the raised central platform 172 of the support body is a cylindrical base member 176 centrally located on the platform 172. Furthermore, projecting up from the base member 176 is a truncated conical member 178 having a conical surface that narrows in a direction away from base member 176. The narrowing will assist in preventing any interference between the valve support body 110 and the prosthetic valve leaflets 3 during the surgical procedure. At the truncated tip of the conical member 178, an opening to a bore 180 is provided for receipt of an end of the post 114 (see
In one embodiment, the post is molded to the conical member 178 of the support body 110 and to the truncated tip of the deflector 112. Other methods of attachment may be used such as a press fit, but the attachment should be secure to prevent detachment during removal of the valve support body 110 and deflector 112 from the prosthetic valve after completion of the surgical procedure. In addition, the post has a small diameter such that it can pass through a central hole 7 of coapted leaflets of the valve, without significantly deforming the leaflets.
A beveled surface 182 is located between the central platform 172 and the base member 176. In an embodiment, a pair of suture holes 184 are located next to each other through the beveled surface in order to provide a securement point for the adapter 116 (see
With reference to
Projecting from the bottom side 200 of the valve support body are a plurality of suture supports 212a, 212b and suture tunnels 214a, 214b, 214c. The suture supports 212a, 212b are rectangular blocks, each with an exposed groove surface 216. The groove is a smooth cylinder or otherwise concave surface. In an embodiment of the invention, the suture supports 212a, 212b are adjacent to each other and their grooved surfaces 216 are aligned such that multiple sutures can be laid across a gap 218 between the suture supports. As will be seen below, this will provide a single cut point to release the valve holder 100 from the prosthetic heart valve 120.
The suture tunnels 214a and 214b each have two columns 220 with an interconnecting span member 222 that together form a tunnel space 224 for receiving one or more sutures therethrough. In one embodiment, there are three support tunnels 214a, 214b, 214c, each located near a respective pair of suture holes 175a, 175b, 175c. Two of the suture tunnels 214a, 214b are located on opposite sides of and adjacent to respective suture supports 212a, 212b such that the tunnel spaces 224 are aligned with the groove surfaces 216 to provide a suture pathway across the gap 218. The third suture tunnel 214c is located next to one of the tool openings 186 and near the third pair of suture holes 175c. It will be appreciated that the number and location of suture supports and suture tunnels for routing and tying down sutures may be varied as desired. In addition, the columns 220 and span members 222 of the suture tunnels are rounded so as not to chafe or abrade the sutures and to provide secure surfaces for tying down the sutures. The valve support body 110 may be made as a single piece out of a rigid plastic material, or other material suitable to safely secure the prosthetic valve during shipment and use.
Packaging guides 230 are also provided on the valve support body 110 in order to secure the valve holder 100 and prosthetic heart valve 120 within a package for shipping. In an embodiment of the invention, the packaging guides are a pair of L-shaped support guides 232 configured to engage packaging components (not shown). A package 60 for the valve holder 110 and prosthetic valve 1 is shown schematically in
With reference to
With reference to
At the other end of the post member 240 of the adapter 116 is a second cylindrical member 246 that has a greater outer diameter than the first cylindrical member 244. Located between the first and second cylindrical members is an anti-rotation member 248 having opposed flat sides 250 and opposed curved sides 252. The anti-rotation member is sized to fit within the central hole 202 of the valve support body 110 and is sized to prevent or restrict rotation between the adapter 116 and the valve support body 110. On the end of the anti-rotation member 248 adjacent the first cylindrical member 244, the opposed curved surfaces 252 project to form abutments 254 that can engage the shoulders 208 in the central hole 202 of the valve support body 110. This prevents the adapter from being inserted too far into the valve support body.
The suture shield 242 extends laterally from the end of the second cylindrical member 246 adjacent to the anti-rotation member 248. The suture shield 242 includes two support arms 280 each having a flat surface 282 that can bear against the bottom side 200 of the valve support body. At the end of each support arm 280, a vertical extension member 284 is provided that projects away from the flat surface in the direction of the second cylindrical member 246. The extension members 284 support a suture cover 286 that is arranged to overlap the suture supports 212a, 212b and the suture tunnels 214a, 214b. The suture cover 286 prevents the surgeon or clinician from prematurely cutting the sutures to release the valve support body 110 from the prosthetic heart valve 120. The length and width of the suture cover 286 is preferably sufficient to cover the entire top of each of the suture supports 212a, 212b and suture tunnels 214a, 214b.
The adapter further includes a tab 290 extending laterally in an opposite direction from the suture shield 242. The tab has a flat surface 292 that, similar to the flat surfaces 282 of the suture shield, can bear against the bottom side 200 of the valve support body 110 to form a firm connection. Suture holes 294 are provided through suture shield 242 and are aligned with the suture holes 184 of the valve support body 110 so that a suture can be tied to secure the adapter 116 to the valve support body 110.
With reference to
With reference to
Assembly of the prosthetic heart valve holder system of the embodiment of
The assembled valve support body 110 and deflector 112 are then attached to the prosthetic heart valve 1 (see
After the suture ring 5 is mounted on the annular base surface 174, the heart valve is rotated on the base surface in order to align the three pairs of suture holes 175a, 175b, 175c of the valve support body with their respective commissure posts 4 of the prosthetic valve. Simultaneously, the deflector arms 132 are aligned with respective tips 6 of the commissure posts 4.
The deflector arms 132 are arranged over the commissure posts 4 such that the tips 6 enter the channels 156 at the outer end portion of each arm. Preferably, the end wall 152 of the deflector arm is wider than the width of the tip and the side flanges 154 cover a portion of the sides of the tip. The angle that the deflector arms 132 form with the central post 114 when mounted to the tips 6 of the commissure post is sufficient to result in the tent-like or umbrella shape, preferably about 25 to 60° such that the ends of the deflector arms attached to the commissure posts are located axially between the central hub 130 and the valve support body 110. In addition, the deflector arms are held taut by the commissure posts 4 causing the deflector to assume an angled tent-like or umbrella shape.
Sutures 11 are used to attach the prosthetic valve to the support body 110 and the arms 132 of the deflector. With reference to
Sutures 11a and 11b are similarly passed through respective pairs of suture holes 175a, 175b, through the suture ring 5, up respective commissure posts 4 to the tips 6, routed out and in through respective holes 158 of the deflector arms 132 (see
The suture 11a, 11b, and 11c also hold the deflector arms 132 taut against the commissure posts 4. This results in the arms 132 assuming a tent-like or umbrella shape that will cause the pre-installed sutures to slide or glide off the umbrella during valve placement and thereby preventing suture looping.
When a handle for the holder is desired (see
The handle 118 is attached to the adapter 116 by guiding the threaded portion 316 of the handle into the central bore 260 of the adapter 116. The unthreaded portion 262 of the central bore (see
During the surgical procedure, the handle 118 may be used to guide the prosthetic heart valve holder system to the native valve annulus. Examples of such a procedure for installing a new mitral valve is described in U.S. Patent Application Publication No. 2002/0013621, and U.S. Pat. No. 6,966,925, both incorporated herein by reference.
In order to secure the prosthetic valve to the native valve annulus, a plurality of sutures can be pre-installed within the mitral valve annulus. The sutures are then brought outside the body and passed through the suture ring 5 of the prosthetic valve 1 of the present invention. The handle 118 is then used to guide the valve holder 100 and prosthetic valve 1 along the pre-installed sutures to the native valve annulus.
During delivery of the valve, the pre-deployed deflector 112, with its umbrella shape, prevents entanglement of the commissure posts with the array of preinstalled sutures. Once the valve engages the native valve annulus, the handle can be removed by a single cut of suture 12 that secures the adapter 116 to the valve support body 110 and the adapter is pulled out of the central hole 202 of the valve support body 110. At the same time, the suture shield 242 of the adapter is also removed, exposing the sutures 11a, 11b, 11c that are arranged across gap 218 (see
The pre-installed sutures may now be tied off to secure the prosthetic valve to the native valve annulus. Once completed, a member of the surgical team can make a single cut across the gap 218 to cut all three sutures 11a, 11b, 11c. The valve holder 100 can then be grasped with a tool, e.g., along the rib 188 between the tool openings 186 (see
With reference to
A first end 416 of each arm is attached to the central hub 412 and each arm extends radially from the central hub to a free end 418. The arms are thin for most of their length, then gradually widen at their free ends to form attachment portions 420. A pair of suture holes 422 are formed through each attachment portion. Sutures may be used to attach the arms to the tips of the commissure posts 402 of the valve 400 as in the first embodiment. It will be appreciated that the deflector 410 may be substituted for the deflector 112 of the first embodiment, or other deflectors described in this application.
With reference to
With reference to
In some situations, it may be desirable to move the deflector from an untented position to a tented position while attached to the prosthetic valve. With reference to
It will be appreciated that several ways of routing sutures between the prosthetic valve 1 and the valve holder 100 are described herein for insuring that those sutures are removed together with the valve holder after the prosthetic valve is delivered to the native valve annulus and that suture routing for one embodiment may be used in other embodiments.
In other alternative embodiments, various different features from the different embodiments discussed above can also be combined into a single modified valve holder. In addition, various other modifications or alternative configurations can also be made to the valve holder according to the above described embodiments of the invention.
For purposes of this description, certain aspects, advantages, and novel features of the embodiments 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 embodiments, 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 embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
In view of the many possible embodiments to which the principles of the disclosure can be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims.
This application is a continuation of U.S. application Ser. No. 15/963,311, filed Apr. 26, 2018, now U.S. Pat. No. 10,799,353, which claims the benefit of U.S. Application No. 62/491,998, filed Apr. 28, 2017, the entire contents all of which incorporated by reference herein for all purposes.
Number | Name | Date | Kind |
---|---|---|---|
3143742 | Cromie | Aug 1964 | A |
3320972 | High et al. | May 1967 | A |
3371352 | Siposs et al. | Mar 1968 | A |
3546710 | Shumakov et al. | Dec 1970 | A |
3574865 | Hamaker | Apr 1971 | A |
3755823 | Hancock | Sep 1973 | A |
3839741 | Haller | Oct 1974 | A |
3997923 | Possis | Dec 1976 | A |
4035849 | Angell et al. | Jul 1977 | A |
4078468 | Civitello | Mar 1978 | A |
4079468 | Liotta et al. | Mar 1978 | A |
4084268 | Ionescu et al. | Apr 1978 | A |
4106129 | Carpentier et al. | Aug 1978 | A |
4172295 | Batten | Oct 1979 | A |
4217665 | Bex et al. | Aug 1980 | A |
4218782 | Rygg | Aug 1980 | A |
4259753 | Liotta et al. | Apr 1981 | A |
RE30912 | Hancock | Apr 1982 | E |
4340091 | Skelton et al. | Jul 1982 | A |
4343048 | Ross et al. | Aug 1982 | A |
4364126 | Rosen et al. | Dec 1982 | A |
4388735 | Ionescu et al. | Jun 1983 | A |
4441216 | Ionescu et al. | Apr 1984 | A |
4451936 | Carpentier et al. | Jun 1984 | A |
4470157 | Love | Sep 1984 | A |
4490859 | Black et al. | Jan 1985 | A |
4501030 | Lane | Feb 1985 | A |
4506394 | Bedard | Mar 1985 | A |
4535483 | Klawitter et al. | Aug 1985 | A |
4566465 | Arhan et al. | Jan 1986 | A |
4605407 | Black et al. | Aug 1986 | A |
4626255 | Reichart et al. | Dec 1986 | A |
4629459 | Ionescu et al. | Dec 1986 | A |
4680031 | Alonso | Jul 1987 | A |
4687483 | Fisher et al. | Aug 1987 | A |
4705516 | Barone et al. | Nov 1987 | A |
4725274 | Lane et al. | Feb 1988 | A |
4731074 | Rousseau et al. | Mar 1988 | A |
4778461 | Pietsch et al. | Oct 1988 | A |
4790843 | Carpentier et al. | Dec 1988 | A |
4851000 | Gupta | Jul 1989 | A |
4888009 | Lederman et al. | Dec 1989 | A |
4914097 | Oda et al. | Apr 1990 | A |
4960424 | Grooters | Oct 1990 | A |
4993428 | Arms | Feb 1991 | A |
5010892 | Colvin et al. | Apr 1991 | A |
5032128 | Alonso | Jul 1991 | A |
5037434 | Lane | Aug 1991 | A |
5147391 | Lane | Sep 1992 | A |
5163955 | Love et al. | Nov 1992 | A |
5258023 | Reger | Nov 1993 | A |
5316016 | Adams et al. | May 1994 | A |
5326370 | Love et al. | Jul 1994 | A |
5326371 | Love et al. | Jul 1994 | A |
5332402 | Teitelbaum | Jul 1994 | A |
5360014 | Sauter et al. | Nov 1994 | A |
5360444 | Kusuhara | Nov 1994 | A |
5376112 | Duran | Dec 1994 | A |
5396887 | Imran | Mar 1995 | A |
5397351 | Pavcnik et al. | Mar 1995 | A |
5423887 | Love et al. | Jun 1995 | A |
5425741 | Lemp et al. | Jun 1995 | A |
5431676 | Dubrul et al. | Jul 1995 | A |
5449384 | Johnson | Sep 1995 | A |
5449385 | Religa et al. | Sep 1995 | A |
5469868 | Reger | Nov 1995 | A |
5487760 | Villafana | Jan 1996 | A |
5488789 | Religa et al. | Feb 1996 | A |
5489296 | Love et al. | Feb 1996 | A |
5489297 | Duran | Feb 1996 | A |
5489298 | Love et al. | Feb 1996 | A |
5500016 | Fisher | Mar 1996 | A |
5533515 | Coller et al. | Jul 1996 | A |
5549665 | Vesely et al. | Aug 1996 | A |
5562729 | Purdy et al. | Oct 1996 | A |
5571215 | Sterman et al. | Nov 1996 | A |
5573007 | Bobo, Sr. | Nov 1996 | A |
5578076 | Krueger et al. | Nov 1996 | A |
5584803 | Stevens et al. | Dec 1996 | A |
5618307 | Donlon et al. | Apr 1997 | A |
5626607 | Malecki et al. | May 1997 | A |
5628789 | Vanney et al. | May 1997 | A |
5693090 | Unsworth et al. | Dec 1997 | A |
5695503 | Krueger et al. | Dec 1997 | A |
5713952 | Vanney et al. | Feb 1998 | A |
5716370 | Williamson, IV et al. | Feb 1998 | A |
5728064 | Burns et al. | Mar 1998 | A |
5728151 | Garrison et al. | Mar 1998 | A |
5735894 | Krueger et al. | Apr 1998 | A |
5752522 | Murphy | May 1998 | A |
5755782 | Love et al. | May 1998 | A |
5766240 | Johnson | Jun 1998 | A |
5800527 | Jansen et al. | Sep 1998 | A |
5814097 | Sterman et al. | Sep 1998 | A |
5814098 | Hinnenkamp et al. | Sep 1998 | A |
5824064 | Taheri | Oct 1998 | A |
5824068 | Bugge | Oct 1998 | A |
5840081 | Andersen et al. | Nov 1998 | A |
5848969 | Panescu et al. | Dec 1998 | A |
5855563 | Kaplan et al. | Jan 1999 | A |
5855601 | Bessler et al. | Jan 1999 | A |
5855801 | Lin et al. | Jan 1999 | A |
5891160 | Williamson, IV et al. | Apr 1999 | A |
5895420 | Mirsch, II et al. | Apr 1999 | A |
5902308 | Murphy | May 1999 | A |
5908450 | Gross et al. | Jun 1999 | A |
5919147 | Jain | Jul 1999 | A |
5921934 | Teo | Jul 1999 | A |
5921935 | Hickey | Jul 1999 | A |
5924984 | Rao | Jul 1999 | A |
5957949 | Leonhardt et al. | Sep 1999 | A |
5972004 | Williamson, IV et al. | Oct 1999 | A |
5984959 | Robertson et al. | Nov 1999 | A |
5984973 | Girard et al. | Nov 1999 | A |
6010531 | Donlon et al. | Jan 2000 | A |
6042554 | Rosenman et al. | Mar 2000 | A |
6042607 | Williamson, IV et al. | Mar 2000 | A |
6066160 | Colvin et al. | May 2000 | A |
6074418 | Buchanan et al. | Jun 2000 | A |
6081737 | Shah | Jun 2000 | A |
6083179 | Oredsson | Jul 2000 | A |
6099475 | Seward et al. | Aug 2000 | A |
6106550 | Magovern et al. | Aug 2000 | A |
6110200 | Hinnenkamp | Aug 2000 | A |
6117091 | Young et al. | Sep 2000 | A |
6126007 | Kari et al. | Oct 2000 | A |
6162233 | Williamson, IV et al. | Dec 2000 | A |
6168614 | Andersen et al. | Jan 2001 | B1 |
6176877 | Buchanan et al. | Jan 2001 | B1 |
6197054 | Hamblin, Jr. et al. | Mar 2001 | B1 |
6217611 | Klostermeyer | Apr 2001 | B1 |
6231561 | Frazier et al. | May 2001 | B1 |
6241765 | Griffin et al. | Jun 2001 | B1 |
6245102 | Jayaraman | Jun 2001 | B1 |
6264611 | Ishikawa et al. | Jul 2001 | B1 |
6283127 | Sterman et al. | Sep 2001 | B1 |
6287339 | Vazquez et al. | Sep 2001 | B1 |
6290674 | Roue et al. | Sep 2001 | B1 |
6312447 | Grimes | Nov 2001 | B1 |
6312465 | Griffin et al. | Nov 2001 | B1 |
6328727 | Frazier et al. | Dec 2001 | B1 |
6350282 | Eberhardt | Feb 2002 | B1 |
6371983 | Lane | Apr 2002 | B1 |
6375620 | Oser et al. | Apr 2002 | B1 |
6402780 | Williamson, IV et al. | Jun 2002 | B2 |
6409674 | Brockway et al. | Jun 2002 | B1 |
6425916 | Garrison et al. | Jul 2002 | B1 |
6440164 | DiMatteo et al. | Aug 2002 | B1 |
6442413 | Silver | Aug 2002 | B1 |
6454799 | Schreck | Sep 2002 | B1 |
6458153 | Bailey et al. | Oct 2002 | B1 |
6468305 | Otte | Oct 2002 | B1 |
6491624 | Lotfi | Dec 2002 | B1 |
6582462 | Andersen et al. | Jun 2003 | B1 |
6585766 | Huynh et al. | Jul 2003 | B1 |
6645143 | VanTassel et al. | Nov 2003 | B2 |
6652464 | Schwartz et al. | Nov 2003 | B2 |
6652578 | Bailey et al. | Nov 2003 | B2 |
6675049 | Thompson et al. | Jan 2004 | B2 |
6682559 | Myers et al. | Jan 2004 | B2 |
6685739 | DiMatteo et al. | Feb 2004 | B2 |
6730118 | Spenser et al. | May 2004 | B2 |
6733525 | Yang et al. | May 2004 | B2 |
6741885 | Park et al. | May 2004 | B1 |
6764508 | Roehe et al. | Jul 2004 | B1 |
6767362 | Schreck | Jul 2004 | B2 |
6773457 | Ivancev et al. | Aug 2004 | B2 |
6786925 | Schoon et al. | Sep 2004 | B1 |
6790229 | Berreklouw | Sep 2004 | B1 |
6790230 | Beyersdorf et al. | Sep 2004 | B2 |
6795732 | Stadler et al. | Sep 2004 | B2 |
6805711 | Quijano et al. | Oct 2004 | B2 |
6893459 | Macoviak | May 2005 | B1 |
6893460 | Spenser et al. | May 2005 | B2 |
6895265 | Silver | May 2005 | B2 |
6908481 | Cribier | Jun 2005 | B2 |
6939365 | Fogarty et al. | Sep 2005 | B1 |
6964682 | Nguyen-Thien-Nhon et al. | Nov 2005 | B2 |
7011681 | Vesely | Mar 2006 | B2 |
7018404 | Holmberg et al. | Mar 2006 | B2 |
7025780 | Gabbay | Apr 2006 | B2 |
7033322 | Silver | Apr 2006 | B2 |
7052466 | Scheiner et al. | May 2006 | B2 |
7070616 | Majercak et al. | Jul 2006 | B2 |
7082330 | Stadler et al. | Jul 2006 | B2 |
7097659 | Woolfson et al. | Aug 2006 | B2 |
7101396 | Artof et al. | Sep 2006 | B2 |
7147663 | Berg et al. | Dec 2006 | B1 |
7153324 | Case et al. | Dec 2006 | B2 |
7195641 | Palmaz et al. | Mar 2007 | B2 |
7201771 | Lane | Apr 2007 | B2 |
7201772 | Schwammenthal et al. | Apr 2007 | B2 |
7238200 | Lee et al. | Jul 2007 | B2 |
7252682 | Seguin | Aug 2007 | B2 |
7261732 | Justino | Aug 2007 | B2 |
RE40377 | Williamson, IV et al. | Jun 2008 | E |
7416530 | Turner et al. | Aug 2008 | B2 |
7422603 | Lane | Sep 2008 | B2 |
7513909 | Lane et al. | Apr 2009 | B2 |
7556647 | Drews et al. | Jul 2009 | B2 |
7569072 | Berg et al. | Aug 2009 | B2 |
7621878 | Ericson et al. | Nov 2009 | B2 |
7871432 | Bergin | Jan 2011 | B2 |
7916013 | Stevenson | Mar 2011 | B2 |
7998151 | St. Goar et al. | Aug 2011 | B2 |
8066650 | Lee et al. | Nov 2011 | B2 |
8248232 | Stevenson et al. | Aug 2012 | B2 |
8253555 | Stevenson et al. | Aug 2012 | B2 |
8340750 | Prakash et al. | Dec 2012 | B2 |
8401659 | Von Arx et al. | Mar 2013 | B2 |
8454684 | Bergin et al. | Jun 2013 | B2 |
8529474 | Gupta et al. | Sep 2013 | B2 |
8622936 | Schenberger et al. | Jan 2014 | B2 |
9101264 | Acquista | Aug 2015 | B2 |
9101281 | Reinert et al. | Aug 2015 | B2 |
9693862 | Campbell et al. | Jul 2017 | B2 |
20010039435 | Roue et al. | Nov 2001 | A1 |
20010039436 | Frazier et al. | Nov 2001 | A1 |
20010041914 | Frazier et al. | Nov 2001 | A1 |
20010041915 | Roue et al. | Nov 2001 | A1 |
20010049492 | Frazier et al. | Dec 2001 | A1 |
20020020074 | Love et al. | Feb 2002 | A1 |
20020026238 | Lane et al. | Feb 2002 | A1 |
20020032481 | Gabbay | Mar 2002 | A1 |
20020058995 | Stevens | May 2002 | A1 |
20020123802 | Snyders | Sep 2002 | A1 |
20020138138 | Yang | Sep 2002 | A1 |
20020151970 | Garrison et al. | Oct 2002 | A1 |
20020188348 | DiMatteo et al. | Dec 2002 | A1 |
20020198594 | Schreck | Dec 2002 | A1 |
20030014104 | Cribier | Jan 2003 | A1 |
20030023300 | Bailey et al. | Jan 2003 | A1 |
20030023303 | Palmaz et al. | Jan 2003 | A1 |
20030036795 | Andersen et al. | Feb 2003 | A1 |
20030040792 | Gabbay | Feb 2003 | A1 |
20030055495 | Pease et al. | Mar 2003 | A1 |
20030105519 | Fasol et al. | Jun 2003 | A1 |
20030109924 | Cribier | Jun 2003 | A1 |
20030114913 | Spenser et al. | Jun 2003 | A1 |
20030125805 | Johnson et al. | Jul 2003 | A1 |
20030130729 | Paniagua et al. | Jul 2003 | A1 |
20030149478 | Figulla et al. | Aug 2003 | A1 |
20030167089 | Lane | Sep 2003 | A1 |
20030236568 | Hojeibane et al. | Dec 2003 | A1 |
20040010296 | Swanson et al. | Jan 2004 | A1 |
20040019374 | Hojeibane et al. | Jan 2004 | A1 |
20040027306 | Amundson et al. | Feb 2004 | A1 |
20040034411 | Quijano et al. | Feb 2004 | A1 |
20040044406 | Woolfson et al. | Mar 2004 | A1 |
20040106976 | Bailey et al. | Jun 2004 | A1 |
20040122514 | Fogarty et al. | Jun 2004 | A1 |
20040122516 | Fogarty et al. | Jun 2004 | A1 |
20040167573 | Williamson et al. | Aug 2004 | A1 |
20040186563 | Lobbi | Sep 2004 | A1 |
20040186565 | Schreck | Sep 2004 | A1 |
20040193261 | Berreklouw | Sep 2004 | A1 |
20040206363 | McCarthy et al. | Oct 2004 | A1 |
20040210304 | Seguin et al. | Oct 2004 | A1 |
20040210307 | Khairkhahan | Oct 2004 | A1 |
20040225355 | Stevens | Nov 2004 | A1 |
20040236411 | Sarac et al. | Nov 2004 | A1 |
20040260389 | Case et al. | Dec 2004 | A1 |
20040260390 | Sarac et al. | Dec 2004 | A1 |
20050010285 | Lambrecht et al. | Jan 2005 | A1 |
20050027348 | Case et al. | Feb 2005 | A1 |
20050033398 | Seguin | Feb 2005 | A1 |
20050043760 | Fogarty et al. | Feb 2005 | A1 |
20050043790 | Seguin | Feb 2005 | A1 |
20050060029 | Le et al. | Mar 2005 | A1 |
20050065594 | DiMatteo et al. | Mar 2005 | A1 |
20050065614 | Stinson | Mar 2005 | A1 |
20050075584 | Cali | Apr 2005 | A1 |
20050075713 | Biancucci et al. | Apr 2005 | A1 |
20050075717 | Nguyen et al. | Apr 2005 | A1 |
20050075718 | Nguyen et al. | Apr 2005 | A1 |
20050075719 | Bergheim | Apr 2005 | A1 |
20050075720 | Nguyen et al. | Apr 2005 | A1 |
20050075724 | Svanidze et al. | Apr 2005 | A1 |
20050080454 | Drews et al. | Apr 2005 | A1 |
20050096738 | Cali et al. | May 2005 | A1 |
20050137682 | Justino | Jun 2005 | A1 |
20050137686 | Salahieh et al. | Jun 2005 | A1 |
20050137687 | Salahieh et al. | Jun 2005 | A1 |
20050137688 | Salahieh et al. | Jun 2005 | A1 |
20050137690 | Salahieh et al. | Jun 2005 | A1 |
20050137692 | Haug et al. | Jun 2005 | A1 |
20050137695 | Salahieh et al. | Jun 2005 | A1 |
20050159811 | Lane | Jul 2005 | A1 |
20050165479 | Drews et al. | Jul 2005 | A1 |
20050182486 | Gabbay | Aug 2005 | A1 |
20050192665 | Spenser et al. | Sep 2005 | A1 |
20050203616 | Cribier | Sep 2005 | A1 |
20050203617 | Forster et al. | Sep 2005 | A1 |
20050203618 | Sharkawy et al. | Sep 2005 | A1 |
20050216079 | MaCoviak | Sep 2005 | A1 |
20050222674 | Paine | Oct 2005 | A1 |
20050228493 | Bicer | Oct 2005 | A1 |
20050234546 | Nugent et al. | Oct 2005 | A1 |
20050240263 | Fogarty et al. | Oct 2005 | A1 |
20050251252 | Stobie | Nov 2005 | A1 |
20050261765 | Liddicoat | Nov 2005 | A1 |
20050283231 | Haug et al. | Dec 2005 | A1 |
20060025857 | Bergheim et al. | Feb 2006 | A1 |
20060052867 | Revuelta et al. | Mar 2006 | A1 |
20060058871 | Zakay et al. | Mar 2006 | A1 |
20060058872 | Salahieh et al. | Mar 2006 | A1 |
20060074484 | Huber | Apr 2006 | A1 |
20060085060 | Campbell | Apr 2006 | A1 |
20060095125 | Chinn et al. | May 2006 | A1 |
20060122634 | Ino et al. | Jun 2006 | A1 |
20060149360 | Schwammenthal et al. | Jul 2006 | A1 |
20060154230 | Cunanan et al. | Jul 2006 | A1 |
20060167543 | Bailey et al. | Jul 2006 | A1 |
20060195184 | Lane et al. | Aug 2006 | A1 |
20060195185 | Lane et al. | Aug 2006 | A1 |
20060195186 | Drews et al. | Aug 2006 | A1 |
20060207031 | Cunanan et al. | Sep 2006 | A1 |
20060241745 | Solem | Oct 2006 | A1 |
20060259136 | Nguyen et al. | Nov 2006 | A1 |
20060271172 | Tehrani | Nov 2006 | A1 |
20060271175 | Woolfson et al. | Nov 2006 | A1 |
20060287717 | Rowe et al. | Dec 2006 | A1 |
20060287719 | Rowe et al. | Dec 2006 | A1 |
20070005129 | Damm et al. | Jan 2007 | A1 |
20070010876 | Salahieh et al. | Jan 2007 | A1 |
20070016285 | Lane et al. | Jan 2007 | A1 |
20070016286 | Herrmann et al. | Jan 2007 | A1 |
20070016288 | Gurskis et al. | Jan 2007 | A1 |
20070043435 | Seguin et al. | Feb 2007 | A1 |
20070078509 | Lotfy | Apr 2007 | A1 |
20070078510 | Ryan | Apr 2007 | A1 |
20070100440 | Figulla et al. | May 2007 | A1 |
20070129794 | Realyvasquez | Jun 2007 | A1 |
20070142906 | Figulla et al. | Jun 2007 | A1 |
20070142907 | Moaddeb et al. | Jun 2007 | A1 |
20070150053 | Gurskis et al. | Jun 2007 | A1 |
20070156233 | Kapadia et al. | Jul 2007 | A1 |
20070162103 | Case et al. | Jul 2007 | A1 |
20070162107 | Haug et al. | Jul 2007 | A1 |
20070162111 | Fukamachi et al. | Jul 2007 | A1 |
20070179604 | Lane | Aug 2007 | A1 |
20070185565 | Schwammenthal et al. | Aug 2007 | A1 |
20070198097 | Zegdi | Aug 2007 | A1 |
20070203575 | Forster et al. | Aug 2007 | A1 |
20070203576 | Lee et al. | Aug 2007 | A1 |
20070213813 | Von Segesser et al. | Sep 2007 | A1 |
20070225801 | Drews et al. | Sep 2007 | A1 |
20070233237 | Krivoruchko | Oct 2007 | A1 |
20070239266 | Birdsall | Oct 2007 | A1 |
20070239269 | Dolan et al. | Oct 2007 | A1 |
20070239273 | Allen | Oct 2007 | A1 |
20070255398 | Yang et al. | Nov 2007 | A1 |
20070260305 | Drews et al. | Nov 2007 | A1 |
20070265701 | Gurskis et al. | Nov 2007 | A1 |
20070270944 | Bergheim et al. | Nov 2007 | A1 |
20070282436 | Pinchuk | Dec 2007 | A1 |
20070288089 | Gurskis et al. | Dec 2007 | A1 |
20080033543 | Gurskis et al. | Feb 2008 | A1 |
20080046040 | Denker et al. | Feb 2008 | A1 |
20080119875 | Ino et al. | May 2008 | A1 |
20080154356 | Obermiller et al. | Jun 2008 | A1 |
20080319543 | Lane | Dec 2008 | A1 |
20090036903 | Ino et al. | Feb 2009 | A1 |
20090192591 | Ryan et al. | Jul 2009 | A1 |
20090192599 | Lane et al. | Jul 2009 | A1 |
20100004739 | Vesely | Jan 2010 | A1 |
20100049313 | Alon et al. | Feb 2010 | A1 |
20100145438 | Barone | Jun 2010 | A1 |
20100256723 | Murray | Oct 2010 | A1 |
20120123284 | Kheradvar | May 2012 | A1 |
20120296382 | Shuros et al. | Nov 2012 | A1 |
20130144379 | Najafi et al. | Jun 2013 | A1 |
20140039609 | Campbell | Feb 2014 | A1 |
20140128964 | Delaloye | May 2014 | A1 |
20140188221 | Chung et al. | Jul 2014 | A1 |
20140364707 | Kintz et al. | Dec 2014 | A1 |
20150045635 | Tankiewicz et al. | Feb 2015 | A1 |
20160045316 | Braido et al. | Feb 2016 | A1 |
20190321170 | Green et al. | Oct 2019 | A1 |
Number | Date | Country |
---|---|---|
0125393 | Nov 1984 | EP |
0143246 | Jun 1985 | EP |
1116573 | Jul 1985 | SU |
1697790 | Dec 1991 | SU |
9213502 | Aug 1992 | WO |
9742871 | Nov 1997 | WO |
Number | Date | Country | |
---|---|---|---|
20210022862 A1 | Jan 2021 | US |
Number | Date | Country | |
---|---|---|---|
62491998 | Apr 2017 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 15963311 | Apr 2018 | US |
Child | 17067598 | US |