Patent Application
20150320557
The present invention relates to methods and apparatus for endovascularly repairing or replacing a heart valve. More particularly, the present invention relates to methods and apparatus for percutaneously repairing or replacing a native heart valve with a replacement valve using an expandable and retrievable anchor.
Heart valve surgery is an often highly invasive operation used to repair or replace a patient's heart valve when there is a narrowing of the native heart valve, commonly referred to as stenosis, or when the native valve leaks or regurgitates. Heart valve surgery is normally an open-heart procedure conducted under general anesthesia. An incision is made through the patient's sternum (sternotomy), and the patient's heart is stopped while blood flow is rerouted through a heart-lung bypass machine.
When replacing the valve, the native valve is excised and replaced with either a biologic or a mechanical valve. Mechanical valves require lifelong anticoagulant medication to prevent blood clot formation, and clicking of the valve often may be heard through the chest. Biologic tissue valves typically do not require such medication. Tissue valves may be obtained from cadavers or may be porcine or bovine, and are commonly attached to synthetic rings that are secured to the patient's heart.
Implantable medical devices can be delivered to a target location within a patient and implanted therein. For example, endoluminal delivery techniques are well known. The delivery system typically includes a sheath and/or a catheter through which the implant is delivered to the target location. The implant is generally deployed from the sheath or catheter at the target location. Some implantable devices are completely self-expanding; they self-expand when released from the sheath or catheter and do not require any further expansion after the self-expanding step. The self-expansion can occur by proximally retracting the sheath or catheter, by pushing the implantable device from the sheath or catheter, or a combination thereof. Some implantable devices, however, are configured and adapted to be actuated during or after the self-expansion step. Exemplary replacement heart valves that can be actuated after a self-expansion step can be found described in US Patent Publication Nos. 2005/0143809 and 2005/0137686, the entireties of which are hereby incorporated by reference herein. It may be advantageous to lock an expandable medical device in a fully deployed and locked configuration to secure the device in the deployed configuration.
During the delivery process the medical device can be actuated by the delivery system using one or more actuators. For example, an actuator (e.g., in the form of a knob on a handle of the delivery system) may be actuated (e.g., turned) to cause a component of the delivery system to move relative to another component in the delivery system or relative to the implantable device, or both. It is generally desirable to make the delivery process as easy as possible for the physician, reduce the time needed to complete the procedure, and reduce the mechanical complexity of the delivery system. In some delivery procedures, multiple components of the delivery system need to be actuated to deploy the implant. It may be desirable to have a delivery system with a low profile for endoluminal delivery.
Without limiting the scope of the invention, a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is also provided for the purposes of complying with 37 C.F.R. §1.72. The abstract is not intended to be used for interpreting the scope of the claims.
In one aspect of the invention, an apparatus for endovascularly replacing a patient's heart valve comprises at least an anchor having an outer surface and an inner surface. The anchor is expandable from a collapsed delivery configuration to a fully deployed configuration. The anchor is further expandable from the collapsed delivery configuration to an at-rest configuration and from the at-rest configuration to the fully deployed configuration. A first locking element and a second locking element are attached to the inner surface of the anchor. The first locking element is engageable with the second locking element.
At least one of the first locking element and the second locking element has a curved surface. In at least one embodiment, the second locking element comprises a plate with an inner surface and a curved outer surface. In at least one embodiment, the second locking element further comprises a tooth pivotally engaged to the inner surface of the plate. In at least one embodiment, the second locking element further comprises a channel defined by the plate and the tooth, where the first locking element is engageable with the channel during locking and unlocking.
In at least one embodiment, the second locking element is attached to the anchor with an attachment member. In one embodiment, this is a thread-like member. In at least one embodiment, the second locking element has a first plurality of holes near a first end and a second plurality of holes near a second end, where the first plurality of holes and the second plurality of holes are separated by at least a portion of the outer surface. In at least one embodiment, the attachment member is threaded through the first plurality of holes and the second plurality of holes to attach the second locking element to the anchor. In one embodiment, the attachment member crosses the outer surface between the first plurality of holes and the second plurality of holes only once.
At least one method of attaching a locking member to an anchoring element of an apparatus for endovascularly replacing a patient's heart valve is also provided herein. A locking member is placed in contact with an inner surface of the anchoring element, wherein the locking member comprises a plate with a curved outer surface, an inner surface, and a thickness therebetween. A plurality of holes extend through the thickness of the plate, wherein the plurality of holes comprises a first plurality of holes and a second plurality of holes. The first plurality of holes and the second plurality of holes are separated by a portion of the curved outer surface. In at least one embodiment, the curved outer surface contacts the inner surface of the anchoring element. A thread-like attachment member is threaded through the plurality of holes such that the thread-like member only crosses the outer surface between the first plurality of holes and the second plurality of holes once to securely attach the locking member to the anchoring element. In one embodiment, after threading the thread-like member through the plurality of holes, at least one knot is formed with the thread-like member.
While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.
Replacement heart valves shown in
In at least one embodiment, the anchoring element 12 is expandable from the collapsed delivery configuration to the at-rest (or partially deployed) configuration, and further expandable from the at-rest configuration to the fully deployed configuration. In the embodiments shown, the anchoring element 12 comprises a braided material and is formed of one or more strands of material. In at least one embodiment, the material is a shape memory material. In at least one embodiment, the anchoring element 12 is heat set in the at-rest configuration, such that when the anchoring element 12 is deployed from the sheath of the delivery system, the anchoring element 12 will begin to naturally begin to shorten and self-expand from the collapsed delivery configuration to the at-rest configuration.
In at least the embodiment shown, the valve leaflets 14 are attached to the posts 16 at the valve's three commissures. Posts 16 therefore support the valve leaflets 14 within the anchoring element 12. The posts 16 and buckles 18 (or other suitable first locking members and second locking members) are both coupled to the anchoring element 12. Posts 16 are moveably coupled to the anchoring element 12 at a location distal to the proximal end of the anchoring element 12. Buckles 18 are affixed to the anchoring element (but also may be moveably coupled to the anchoring element like the posts) at a proximal region of the anchoring element 12.
As shown in
In at least one embodiment, each post 16 has a locking element that is configured to lock with a corresponding locking element of the associated buckle 18. When the anchoring element 12 is in the collapsed configuration as shown in
In the embodiments shown, the anchoring element comprises a braided material, such as nitinol, and is formed of one or more strands of material. In one embodiment the anchoring element 12 is formed of a shape memory material and is heat set in a self-expanded configuration, such that when the anchoring element is deployed from the sheath of the delivery system, the braid will begin to naturally begin to shorten and expand from the collapsed delivery configuration to the at-rest or partially deployed configuration. This is described in more detail in U.S. Patent Publication Nos. 2005/0137686 and 2005/0143809, the entireties of which are incorporated by reference herein. Once the anchoring element 12 has expanded to the at-rest (or partially deployed) configuration, at least one of the actuators 106A and 106B is actuated via an actuator on a handle disposed external to the patient. The actuators are described in more detail at least in U.S. Patent Publication Nos. 2005/0137686 and 2005/0143809, the entireties of which are incorporated by reference herein. Actuators 106B can be actuated in the proximal direction relative to the actuation elements 106A, which applies a proximally directed force to a distal region of the anchoring element. Actuators 106A can, alternatively or in addition to the proximally directed force, be actuated in a distal direction to apply a distally directed force on a proximal region of the anchoring element 12. The axially directed forces actively foreshorten the anchoring element, moving the posts 16 closer to the buckles 18 until the posts 16 and buckles 18 lock together to lock the anchoring element 12 in a fully deployed and locked configuration. The anchoring element 12 in the locked configuration is therefore shorter than it is in the partially-deployed configuration.
The above provides a general description of an exemplary replacement heart valve. Additional details of this and similar embodiments of replacement heart valves, including details of various aspects of such valves and delivery, deployment, locking, repositioning, and release processes that may be incorporated into this and other embodiments can be found at least in U.S. Pat. Nos. 7,329,279, 7,381,219, 7,445,631, 7,748,389, 7,780,725, 7,824,442, 7,824,443; U.S. Patent Publication Nos. 2005/0112355, 2005/0137686, 2005/0137687, 2005/0137688, 2005/0137689, 2005/0137691, 2005/0137692, 2005/0137694, 2005/0137695, 2005/0137696, 2005/0137697, 2005/0137701, 2005/0143809, 2006/0058872, 2006/0173524, 2006/0253191, 2007/0010876, 2007/0024452, 2007/0112355, 2007/0118214, 2007/0162107, 2007/0203503, 2008/0125859, 2008/0234814, 2009/0076598, 2009/0054969, 2009/0264997, 2010/0121434, 2010/0280495; and WO Publication Nos. 2005/062980, 2005/065585, 2006/009690, 2007/053243, 2007/058847, which are incorporated by reference herein in their entireties.
The inventive buckle and/or post described herein correct the issues described above with respect to prior art configurations.
In at least the embodiments shown, the plate 222 has an inner surface 242, an outer surface 244, and a thickness therebetween. The tooth 220 is attached to the inner surface 242 of plate 22 and can pivot relative thereto. The plate 222 has a first side 246 and a second side 248. As shown most clearly in
In at least one embodiment, the outer surface 244 has a similar radius of curvature as the anchoring element 212 in the fully deployed configuration. In one embodiment, the outer surface 244 has a similar radius of curvature as the anchoring element 212 in the collapsed delivery configuration.
In a preferred embodiment, radius of curvature of the outer surface 244 is between the radius of curvature of the anchoring element 212 in the collapsed delivery configuration and the radius of curvature of the anchoring element 212 in the fully deployed configuration. In at least one embodiment, the radius of curvature of the outer surface of the buckle is a weighted average of the radius of curvature of the anchoring element 212 in the collapsed delivery configuration and the radius of curvature of the anchoring element 212 in the fully deployed configuration. In at least one embodiment, the weighted average is determined by the following equation: rBuckle=x(rDeployed)+(1−x)(rCollapsed), where x is a weighted factor. In one embodiment, the weighted factor is between about 0.10 and 0.35. In one embodiment, the weighted factor is between about 0.25 and 0.26.
In at least one embodiment, the curved outer surface 244 of the buckle has an arc length between about 10% and about 30% of the circumference of the inner surface of the anchoring element 212 in the collapsed configuration. Preferably, the arc length is between about 20% and about 25%. In at least one embodiment, the curved outer surface 244 of the buckle has an arc length between about 1% and about 10% of the circumference of the inner surface of the anchoring element 212 in the deployed configuration. Preferably, the arc length is between about 3% and about 7%.
The curved surface, as shown at least in
In at least one embodiment, shown in
Although the above describes the buckle as having an outer surface with a single curve, the buckle may have an outer surface with multiple curves, or an outer surface that is beveled, or an outer surface with a contour that matches the contours inner surface of the stent.
As discussed previously above, the posts may also have a curved surface. As shown in
In at least one embodiment, the outer surface 264 has a radius of curvature similar to the anchoring element 212 in the fully deployed configuration. In one embodiment, the outer surface 264 has a radius of curvature similar to the anchoring element 212 in the collapsed delivery configuration. In at least one embodiment, the outer surface 264 has a radius of curvature similar to the outer surface 244 of the buckle 218. In at least one embodiment, the sides 266, 268 contact the anchoring element 212 in the collapsed delivery configuration, as shown in
The curved outer surface 264 of the posts allows the inventive posts 216 to be spaced apart equidistantly in at least the collapsed configuration. Desirably, the posts 216 are spaced apart substantially equidistantly in each of the collapsed configuration, at-rest configuration, and fully deployed configuration. “Substantially equidistantly” is defined as a difference between about 0% and 5% between the spacings between adjacent posts 216 in one of the configurations. In at least one embodiment, shown in
In at least one embodiment, the curved outer surface 264 of the post has an arc length between about 3% and about 30% of the circumference of the inner surface of the anchoring element 212 in the collapsed configuration. Preferably, the arc length is between about 5% and about 15%. In at least one embodiment, the curved outer surface 264 of the post has an arc length between about 1% and about 5% of the circumference of the inner surface of the anchoring element 212 in the deployed configuration. Preferably, the arc length is between about 2% and about 3%.
Referring back to
As shown in
As shown in
In at least one embodiment the buckle is attached to the anchoring element 212 by threading the attachment member 270 through the plurality of holes 250. In one embodiment, the step of threading the attachment member 270 through the plurality of holes 250 comprises:
In some embodiments, steps (i)-(vi) are repeated. In one embodiment, the step of threading the thread-like member through the plurality of holes further comprises:
In some embodiments, steps (vii)-(xii) are also repeated.
As shown in
In at least one embodiment, the attachment member 270 goes over at least one filament of the braided anchoring element 212. The attachment member 270 then enters hole 250-2 from the outer surface 244 to form a second stitch. As shown in
Although the above is described with respect to a particular hole arrangement of six holes, the method can be applied to buckles with more or less holes. For instance, the method can comprise:
In some embodiments, steps (i)-(vi) are repeated.
In at least one embodiment, the step of threading the attachment member through the plurality of holes further comprises:
In some embodiments, steps (vii)-(xii) are also repeated.
To secure the attachment member 270, the ends of the attachment member are tied with one slip knot followed by a square knot. Preferably, the knot is ended towards the bottom 254 of the buckle 218. In some embodiments, a heat treatment may be applied to at least a portion of attachment member 270, which may or may not include the knot. In some embodiments, a coating may be applied to at least a portion of attachment member 270, which may or may not include the knot.
While the figures shown herein show only a curved outer surface of the plate, in at least one embodiment the inner surface of the plate is also curved. In at least one embodiment, the radius of curvature of the outer surface is the same as the radius of curvature of the inner surface. In one embodiment, the tooth has a first surface and a second surface parallel to the first surface, the first surface is adjacent to the inner surface of the plate. In at least one embodiment, the second surface of the tooth also has a curved surface with a radius of curvature. In one embodiment, the radius of curvature of the second surface of the tooth is the same as the radius of curvature of the outer surface of the tooth. In one embodiment, the radius of curvature of the second surface of the tooth is the same as the radius of curvature of the outer surface of the tooth.
The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from originally filed claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below (e.g. originally filed claim 3 may be taken as alternatively dependent from originally filed claim 2; originally filed claim 4 may be taken as alternatively dependent on originally filed claim 2, or on originally filed claim 3; originally filed claim 6 may be taken as alternatively dependent from originally filed claim 5; etc.).
This completes the description of the preferred and alternate embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.
This application is a continuation of U.S. application Ser. No. 13/888,925, filed May 7, 2013, which claims priority from U.S. Application No. 61/644,673, filed on May 9, 2012, the entire contents of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61644673 | May 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13888925 | May 2013 | US |
| Child | 14803792 | US |
