Patent Grant
10398548
The present invention is related to heart valve replacement, and more particularly to devices, systems, and methods for transcatheter delivery of collapsible prosthetic heart valves.
Prosthetic heart valves that are collapsible to a relatively small circumferential size may be delivered into a patient less invasively than valves that are not collapsible. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility may avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.
Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. To place such a valve into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size. For example, a conventional collapsible prosthetic valve is typically collapsed and retained in a collapsed state by a sheath for delivery into the patient, for example, through a femoral artery or through the apex of the heart.
An end of a guide wire may be inserted percutaneously into the artery or the heart of a patient just beyond a desired implant site to establish a guide for an implantable delivery device to follow. The desired implant site is often at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve. Once the delivery apparatus containing the prosthetic valve has reached this site, the valve may be deployed or released from the delivery apparatus and re-expanded to full operating size. For self-expanding valves, the stent automatically begins to expand as the sheath covering the valve is withdrawn.
In certain transapical delivery systems employing self-expanding aortic valves, for example, after the delivery system has been positioned for deployment, the annulus end of the valve may be unsheathed and expanded first, while the aortic end of the valve remains sheathed. Once the annulus end of the valve has expanded, it may be determined that the valve needs to be repositioned in the patient's aortic annulus. To accomplish this, the user (such as a surgeon or an interventional cardiologist) may resheath the annulus end of the valve so that the valve can be repositioned while in a collapsed state. After the valve has been repositioned, the user can again deploy the valve.
Despite the various improvements that have been made to the collapsible prosthetic heart valve delivery process, conventional delivery devices, systems, and methods suffer from some shortcomings. For example, in a conventional delivery device for collapsible prosthetic valves, such as a transapical delivery device 7 shown in
There is therefore a need for further improvements to the devices, systems, and methods for transcatheter delivery of collapsible prosthetic heart valves. Among other advantages, the present invention may address one or more of these needs.
One aspect of the present invention provides a device for delivering a medical implant into a patient. One embodiment of the delivery device includes a first sheath having a proximal end, a distal end and a longitudinal axis, the distal end having a surface disposed at an oblique angle relative to the longitudinal axis of the proximal sheath; and a distal sheath connected to the distal end of the proximal sheath, the distal sheath having a proximal end, a distal end and a longitudinal axis. The proximal end of the distal sheath has a surface disposed at an oblique angle relative to the longitudinal axis of the distal sheath, the proximal end surface of the distal sheath being in mating engagement with the distal end surface of the proximal sheath. The distal sheath is rotatable relative to the proximal sheath from a first position in which the longitudinal axis of the distal sheath is substantially coaxial with the longitudinal axis of the proximal sheath, to a second position in which the longitudinal axis of the distal sheath is oriented at an oblique angle to the longitudinal axis of the proximal sheath. The oblique angle at which the distal end surface of the proximal sheath is oriented is preferably the same as the oblique angle at which the proximal end surface of the distal sheath is oriented. The distal sheath may be rotated by at least about 180° from the first position to the second position. An atraumatic tip may be connected to the distal end of the distal sheath.
The proximal sheath may be rotatably connected to the distal sheath by an axle. One end of the axle may be fixedly connected to one of the proximal sheath or distal sheath, while the other end of the axle may be rotatably connected to the other of the proximal sheath or distal sheath. Alternatively, both ends of the axle may be rotatably connected to the respective sheaths. Rather than an axle, the proximal sheath may be connected to the distal sheath by a ball-and-socket connection.
The device may further include a locking mechanism having a first position permitting rotation of the distal sheath relative to the proximal sheath, and a second position preventing rotation of the distal sheath relative to the proximal sheath. The locking mechanism may include an elongated member movable in the proximal sheath between a retracted position and an extended position, and at least one recess in the distal sheath, the elongated member in the extended position being receivable in the recess to prevent rotation of the distal sheath relative to the proximal sheath, and the elongated member in the retracted position being free of the recess to permit rotation of the distal sheath relative to the proximal sheath. A spring may be disposed on the elongated member for biasing the elongated member to the extended position.
The proximal sheath may include a lumen extending between the proximal end of the proximal sheath and the distal end of the proximal sheath, and the distal sheath may include a lumen extending between the proximal end of the distal sheath and the distal end of the distal sheath, the lumen of the proximal sheath being in communication with the lumen of the distal sheath.
One or both of the distal end surface of the proximal sheath and the proximal end surface of the distal sheath may be flat, curvate, hemispheroidal, or any other desired shape.
Another aspect of the present invention provides a method for implanting a prosthetic heart valve into a patient. The method includes inserting a delivery device into the patient, the delivery device including a proximal sheath, a distal sheath and a prosthetic heart valve assembled in the distal sheath. The proximal sheath has a proximal end, a distal end and a longitudinal axis, the distal end having a surface disposed at an oblique angle relative to the longitudinal axis of the proximal sheath. The distal sheath is connected to the distal end of the proximal sheath, and has a proximal end, a distal end and a longitudinal axis. The proximal end of the distal sheath has a surface disposed at an oblique angle relative to the longitudinal axis of the distal sheath, the proximal end surface of the distal sheath being in mating engagement with the distal end surface of the proximal sheath. The method further includes rotating the distal sheath relative to the proximal sheath to orient the longitudinal axis of the distal sheath at an oblique angle to the longitudinal axis of the proximal sheath; and deploying the prosthetic heart valve from the distal sheath.
The proximal sheath may have a lumen extending from the proximal end of the proximal sheath to the distal end of the proximal sheath, and the distal sheath may have a lumen extending from the proximal end of the distal sheath to the distal end of the distal sheath. In such event, the method may further include inserting a guidewire into the patient; and inserting the delivery device over the guidewire by passing the guidewire through the lumen in the distal sheath and the lumen in the proximal sheath.
Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope.
In the present application, reference is made to particular features of the invention. It is to be understood that the disclosure of the invention in this application is intended to include all possible combinations of such features, whether or not such combinations have been particularly described. For example, where a feature is disclosed in the context of a particular aspect, arrangement, or embodiment of the invention, that feature can also be used, to the extent possible, in combination with and/or in the context of other aspects, arrangements, and embodiments of the invention described herein.
The term “comprises” and grammatical equivalents thereof are used herein to mean that other components, ingredients, steps, etc. are optionally present. For example, an article “comprising” (or “which comprises”) components A, B, and C can consist of (i.e., contain) only components A, B, and C, or can consist of not only components A, B, and C, but also one or more other components. The term “step of” does not mean “step for”.
Where reference is made herein to a method comprising two or more defined steps, the defined steps can be carried out in any order or simultaneously (except where the context excludes that possibility), and the method can include one or more other steps which are carried out before any of the defined steps, between two of the defined steps, or after all of the defined steps (except where the context excludes that possibility).
The term “at least” followed by a number is used herein to denote the start of a range beginning with that number (which can be a range having an upper limit or no upper limit, depending on the variable being defined). For example, “at least 1” means 1 or more than 1.
As used herein, the terms “proximal” and “distal” are to be taken as relative to a user (e.g., a surgeon or an interventional cardiologist) of the disclosed delivery devices. “Proximal” is to be understood as relatively close to the user and “distal” is to be understood as relatively farther away from the user.
As described further herein, a device for delivering collapsible prosthetic heart valves (or other types of collapsible stents) in accordance with the present invention may include a catheter having proximal and distal portions, the longitudinal axis of the distal portion being substantially coaxial with the longitudinal axis of the proximal portion in one position, and being oriented at varying oblique angles to the longitudinal axis of the proximal portion in other positions to enable the device to deliver a prosthetic heart valve in substantial axial alignment with the native annulus in which the valve is to be deployed.
Referring now to
At its distal end, device 100 may include a proximal retainer 142 and a distal retainer 144 spaced apart by a hollow shaft 155 so as to define a receiving compartment therebetween. An implantable device, such as a collapsible prosthetic heart valve 50, may be mounted in the receiving compartment around shaft 155. As illustrated in
An atraumatic tip 140 formed from a soft polymer may be fixedly connected to the distal end of distal sheath 162. The tip 140 may have a cross-section that matches the cross-section of distal sheath 162. An inner tubular shaft 148 may be connected at one end to tip 140, and may extend through hollow shaft 155 and through proximal sheath 160 to the proximal end thereof. Shaft 148 has a central lumen 147 which communicates with a bore 141 extending longitudinally through tip 140. Lumen 147 and bore 141 together define a channel through device 100 for a guidewire (not shown). Preferably, lumen 147 remains patent through shaft 148 whether the longitudinal axes of proximal sheath 160 and distal sheath 162 are coaxially aligned, or are disposed at an oblique angle to one another, thereby enabling device 100 to be advanced over the guidewire in either a coaxial or angularly deflected configuration. Pushing inner shaft 148 in a distal direction will cause distal sheath 162 to slide distally to an open position relative to proximal sheath 160, and pulling inner shaft 148 in a proximal direction will cause the distal sheath to slide proximally to a closed position relative to the proximal sheath.
In the fully closed position, the distal sheath 162 may be in a proximalmost position covering the valve 50 with its proximal end 164 abutting the end wall 166 of the proximal sheath 160. In the fully opened position, the distal sheath 162 may be in a distalmost position with its proximal end 164 spaced from the end wall 166 of the proximal sheath to expose the prosthetic valve 50 for deployment. Although the figures illustrate a gap between the proximal end 164 of distal sheath 162 and end wall 166 in the closed position of the distal sheath, that gap is merely for the purpose of illustrating the various components of device 100. Thus, in the fully closed position, the proximal end 164 of distal sheath 162 and end wall 166 will preferably be in abutting relationship as will be described further below.
The proximal sheath 160 and the distal sheath 162 may be connected by a tubular axle 170. As clearly seen in
Device 100 may further include a locking rod 180 which extends along the length of proximal sheath 160 in a position offset from the central axis thereof. A compression spring 182 may be assembled around the distal end of rod 180 and constrained between an end member 185 of a spring retainer 184 mounted to the sheath end wall 166 and a stop ring 186 fixedly mounted to the locking rod. Spring 182 may bias locking rod 180 distally so that the distal end thereof projects through an aperture 188 in the sheath end wall 166, and into one of a series of recesses 189 in the proximal retainer 142. The engagement of locking rod 180 in one of recesses 189 fixes the rotational position of distal sheath 162 relative to the proximal sheath 160. Preferably, retainer 142 includes an appropriate number of recesses 189 along its outer periphery to lock the distal sheath 162 at any number of desired rotational angles relative to the proximal sheath 160. The size of spring 182 is selected so that locking rod 180 may be retracted by an amount sufficient to move the distal end of the rod out from a recess 189, thereby freeing the distal sheath 162 to rotate relative to proximal sheath 160.
In an initial fully closed position, shown in
The angle formed by the intersection of the longitudinal axes of the distal sheath 162 and the proximal sheath 160 increases or decreases as the sheaths are rotated relative to one another. When the end wall 166 of the proximal sheath 160 and the proximal end 164 of the distal sheath 162 are both flat and disposed at the same oblique angle to the longitudinal axes of their respective sheaths, the maximum angular displacement between the longitudinal axes will occur when the sheaths have been rotated from their coaxial configuration 180° relative to one another. The amount of angular displacement achieved preferably is at least about 15°. However, the angular displacement should be sufficient to enable the distal sheath 162 to be substantially axially aligned with the native aortic annulus. When the oblique angles at which the proximal end 164 of distal sheath 162 and the sheath end wall 166 are disposed are about equal, the maximum angular displacement that may be achieved will be about twice the oblique angle. Thus, for example, when the oblique angle is about 15°, the maximum angular displacement achieved when the distal sheath 162 is rotated 180° relative to the proximal sheath 160 will be about 30°. It will be appreciated that the maximum angular displacement which device 100 may achieve may be increased by increasing the oblique angle of at least one of proximal end 164 or end wall 166 relative to the longitudinal axes of their respective sheaths. However, if the oblique angles are not equal, coaxial alignment will be difficult to achieve, if achievable at all.
In order for distal sheath 162 to become angularly displaced relative to proximal sheath 160, it is necessary for inner shaft 148 to be able to bend at the interface between the sheaths. It will be appreciated that this may be accomplished in any number of ways while still maintaining the ability of inner shaft 148 to control the longitudinal movement of distal sheath 162 relative to proximal sheath 160. For example, inner shaft 148 may be formed from first and second substantially rigid portions 148a, 148b joined together by a relatively stiff spring, a length of polymer tubing or another flexible tubular material 149 which will enable the rigid portions to move at substantially any angle relative to one another. Alternatively, the rigid portions may be joined together by a ball and socket joint (not shown) which similarly will provide for unlimited angular displacement between the rigid shaft lengths. Thus, the substantially rigid portions of shaft 148 may be connected by any joint that will enable the portions of the shaft to be deflected from substantially coaxial alignment, but that will still retain sufficient strength in both compression and tension to displace distal sheath 162 longitudinally relative to proximal sheath 160.
The delivery device 100 may be inserted into a patient during a minimally invasive surgical procedure such as, for example, to replace a native heart valve with a collapsible prosthetic heart valve. During a transapical surgical procedure to replace the native aortic valve, device 100 may be locked in the straight or coaxial position and inserted through the apex of the heart and the left ventricle and advanced toward the native aortic valve. As the distal tip 140 of device 100 contacts the aortic annulus 6, locking rod 180 may be retracted until the distal end thereof is fully removed from recess 189 in proximal retainer 142, freeing the distal sheath 162 for rotation relative to the proximal sheath 160. As the proximal sheath 160 is rotated by the user, friction between distal tip 140 and the native valve annulus 6 will inhibit the rotation of distal sheath 162. As a result, proximal sheath 160 will rotate relative to distal sheath 162, thereby deflecting the longitudinal axis of distal sheath 162 relative to the longitudinal axis of proximal sheath 160. Locking rod 180 may then be released, whereupon spring 182 will bias the rod through aperture 188 and into a different recess 189 in proximal retainer 142. The creation of an angle between proximal sheath 160 and distal sheath 162 will enable the distal tip 140 to be directed away from the native valve annulus 6 and the interior wall 3 of aortic arch 2, and will enable device 100 to be advanced further into and through the native valve annulus. As device 100 is advanced, the distal tip 140 will again approach the interior wall 3 of aortic arch 2, and the locking rod 180 may again be retracted and proximal sheath 160 rotated relative to distal sheath 162 to increase the angle between the longitudinal axes of the sheaths. Locking rod 180 may then be released to engage a different recess 189, locking the sheaths relative to one another in this new position. This procedure may be repeated as device 100 is advanced through aortic annulus 6 until distal sheath 162 is substantially in axial alignment with the native valve annulus and sufficiently advanced therethrough for deployment of valve 50. Following deployment, the procedure may be reversed, perhaps with fewer increments, to remove device 100 from the patient. Although the foregoing describes incremental rotations between distal sheath 162 and proximal sheath 160 as device 100 is advanced into and through aortic annulus 6, it will be appreciated that the procedure may be accomplished with only a single 180° rotation of the sheaths relative to one another. In such event, device 100 may be configured so as to be lockable in only two positions, namely, a coaxial position and a position rotated 180° from the coaxial position.
An alternate embodiment of a delivery device 200 is shown in
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
The present application is a divisional of U.S. patent application Ser. No. 13/790,132 filed Mar. 8, 2013, now U.S. Pat. No. 9,532,871, which claims the benefit of U.S. Provisional Patent Application No. 61/642,889 filed May 4, 2012, the disclosures of which are hereby incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 3384088 | Miseo | May 1968 | A |
| 3657744 | Ersek | Apr 1972 | A |
| 3724238 | Retali et al. | Apr 1973 | A |
| 4423730 | Gabbay | Jan 1984 | A |
| 4641657 | Ellis | Feb 1987 | A |
| 5368592 | Stern et al. | Nov 1994 | A |
| 5372587 | Hammerslag et al. | Dec 1994 | A |
| 5405344 | Williamson et al. | Apr 1995 | A |
| 5507725 | Savage et al. | Apr 1996 | A |
| 5549594 | Brunken | Aug 1996 | A |
| 5569270 | Weng | Oct 1996 | A |
| 5575799 | Bolanos et al. | Nov 1996 | A |
| 5749881 | Sackier et al. | May 1998 | A |
| 5843167 | Dwyer et al. | Dec 1998 | A |
| 5868685 | Powell et al. | Feb 1999 | A |
| 5924424 | Stevens et al. | Jul 1999 | A |
| 5968068 | Dehdashtian et al. | Oct 1999 | A |
| 6077297 | Robinson et al. | Jun 2000 | A |
| 6183432 | Milo | Feb 2001 | B1 |
| 6306141 | Jervis | Oct 2001 | B1 |
| 6464684 | Galdonik | Oct 2002 | B1 |
| 6599237 | Singh | Jul 2003 | B1 |
| 6623518 | Thompson et al. | Sep 2003 | B2 |
| 6743239 | Kuehn et al. | Jun 2004 | B1 |
| 6814746 | Thompson et al. | Nov 2004 | B2 |
| 6830584 | Seguin | Dec 2004 | B1 |
| 7018406 | Seguin et al. | Mar 2006 | B2 |
| 7300431 | Dubrovsky | Nov 2007 | B2 |
| 7311730 | Gabbay | Dec 2007 | B2 |
| 7510572 | Gabbay | Mar 2009 | B2 |
| 7637905 | Saadat et al. | Dec 2009 | B2 |
| 7682390 | Seguin | Mar 2010 | B2 |
| 7803185 | Gabbay | Sep 2010 | B2 |
| 7811277 | Boulais | Oct 2010 | B2 |
| 9227990 | Phull et al. | Jan 2016 | B2 |
| 9414915 | Lombardi | Aug 2016 | B2 |
| 20030050694 | Yang et al. | Mar 2003 | A1 |
| 20030233108 | Gellman et al. | Dec 2003 | A1 |
| 20040210304 | Seguin et al. | Oct 2004 | A1 |
| 20050137622 | Griffin | Jun 2005 | A1 |
| 20050137695 | Salahieh et al. | Jun 2005 | A1 |
| 20050137697 | Salahieh et al. | Jun 2005 | A1 |
| 20050165352 | Henry et al. | Jul 2005 | A1 |
| 20050177138 | Dubrovsky | Aug 2005 | A1 |
| 20050222604 | Schaeffer | Oct 2005 | A1 |
| 20060058872 | Salahieh et al. | Mar 2006 | A1 |
| 20060074484 | Huber | Apr 2006 | A1 |
| 20060100687 | Fahey et al. | May 2006 | A1 |
| 20060106415 | Gabbay | May 2006 | A1 |
| 20060142848 | Gabbay | Jun 2006 | A1 |
| 20060167468 | Gabbay | Jul 2006 | A1 |
| 20060235502 | Belluche et al. | Oct 2006 | A1 |
| 20060259120 | Vongphakdy et al. | Nov 2006 | A1 |
| 20070010876 | Salahieh et al. | Jan 2007 | A1 |
| 20070027534 | Bergheim et al. | Feb 2007 | A1 |
| 20070043259 | Jaffe et al. | Feb 2007 | A1 |
| 20070043435 | Seguin et al. | Feb 2007 | A1 |
| 20070055358 | Krolik et al. | Mar 2007 | A1 |
| 20070073376 | Krolik et al. | Mar 2007 | A1 |
| 20070073391 | Bourang et al. | Mar 2007 | A1 |
| 20070088431 | Bourang et al. | Apr 2007 | A1 |
| 20070112422 | Dehdashtian | May 2007 | A1 |
| 20070162100 | Gabbay | Jul 2007 | A1 |
| 20070168013 | Douglas | Jul 2007 | A1 |
| 20070203575 | Forster et al. | Aug 2007 | A1 |
| 20070239271 | Nguyen | Oct 2007 | A1 |
| 20070244552 | Salahieh et al. | Oct 2007 | A1 |
| 20070250113 | Hegeman et al. | Oct 2007 | A1 |
| 20080065122 | Stack et al. | Mar 2008 | A1 |
| 20080071369 | Tuval et al. | Mar 2008 | A1 |
| 20080147160 | Ghione et al. | Jun 2008 | A1 |
| 20080147182 | Righini et al. | Jun 2008 | A1 |
| 20080228223 | Alkhatib | Sep 2008 | A1 |
| 20090054975 | del Nido et al. | Feb 2009 | A1 |
| 20090062606 | Ueda et al. | Mar 2009 | A1 |
| 20090062839 | Kurrus | Mar 2009 | A1 |
| 20100004740 | Seguin et al. | Jan 2010 | A1 |
| 20100204708 | Sharma | Aug 2010 | A1 |
| 20100228152 | Fisher et al. | Sep 2010 | A1 |
| 20100228191 | Alvarez et al. | Sep 2010 | A1 |
| 20100286768 | Alkhatib | Nov 2010 | A1 |
| 20100298931 | Quadri et al. | Nov 2010 | A1 |
| 20110098800 | Braido et al. | Apr 2011 | A1 |
| 20110207999 | Torisawa et al. | Aug 2011 | A1 |
| 20110224678 | Gabbay | Sep 2011 | A1 |
| 20110245917 | Savage et al. | Oct 2011 | A1 |
| 20120078350 | Wang et al. | Mar 2012 | A1 |
| 20120303111 | Dwork et al. | Nov 2012 | A1 |
| 20130060328 | Rothstein | Mar 2013 | A1 |
| 20130103047 | Steingisser et al. | Apr 2013 | A1 |
| 20130274870 | Lombardi et al. | Oct 2013 | A1 |
| 20130297012 | Willard | Nov 2013 | A1 |
| 20130297102 | Hughes et al. | Nov 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 1129744 | Sep 2001 | EP |
| 1157673 | Nov 2001 | EP |
| 1716822 | Nov 2006 | EP |
| 1926455 | Jun 2008 | EP |
| 2765098 | Dec 1998 | FR |
| 9510317 | Apr 1995 | WO |
| 2006138173 | Dec 2006 | WO |
| 07071436 | Jun 2007 | WO |
| 08070797 | Jun 2008 | WO |
| 10051025 | May 2010 | WO |
| 10087975 | Aug 2010 | WO |
| 2010127162 | Nov 2010 | WO |
| 2012112469 | Aug 2012 | WO |
| 2013166355 | Nov 2013 | WO |
| 2014130160 | Aug 2014 | WO |
| Entry |
|---|
| Ruiz, Carlos, Overview of PRE-CE Mark Transcatheter Aortic Valve Technologies, Euro PCR, May 25, 2010. |
| Quaden, Rene, et al., Percutaneous aortic valve replacement: resection before implantation, 836-840,European J. of Cardio-thoracic Surgery, 27 (2005). |
| International Search Report for Application No. PCT/US2013/078306 dated May 2, 2014. |
| International Search Report and Written Opinion for Application No. PCT/US2013/039405 dated Sep. 23, 2013. |
| International Search Report and Written Opinion for Application No. PCT/US2014/054025 dated Nov. 19, 2014. |
| International Search Report and Written Opinion for Application No. PCT/US2014/055053 dated Nov. 24, 2014. |
| Number | Date | Country | |
|---|---|---|---|
| 20170056168 A1 | Mar 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61642889 | May 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13790132 | Mar 2013 | US |
| Child | 15350251 | US |
