Patent ID: 12239530

In the figures,1: a delivery catheter;2: a handle;3, a prosthetic valve;11: a guide tip;12: a capsule;13: an outer sheath;14: an anchor;15: an inner sheath;21: an outer sheath actuation member;22: an inner sheath actuation member;141: an embedded section;1411: a first strip unit;1412, a second strip unit;1421, a first spring;1422, a second spring;142, a pull thread; and143, a joint.

DETAILED DESCRIPTION

The above and other features, aspects and objects of the present invention will be more readily apparent from the following detailed description of specific embodiments thereof.

As shown inFIG.1, a prosthetic valve delivery catheter according to an embodiment of the present invention includes an outer sheath assembly and an inner sheath assembly. The outer sheath assembly includes a capsule12in which the prosthetic valve3can be received and an outer sheath13fixedly connected at one end to the capsule12. The inner sheath assembly includes an inner sheath15and an anchor14fixedly connected to the inner sheath15. The inner sheath assembly is arranged within a lumen of the outer sheath assembly.

As shown inFIGS.1to2, the prosthetic valve delivery catheter according to the present invention may further include a guide tip11connected to the inner sheath15. Preferably, the guide tip11has a streamlined outer contour, which can avoid the guide tip from scratching the inner wall of a blood vessel and can help in guiding the advancement of the entire delivery catheter through the blood vessel.

In implementations of the present invention, the fixed connection of the capsule12to the outer sheath13may be accomplished by a smooth transition so that an outer surface of the delivery catheter generally appears smooth. The capsule12may have an outer diameter that is equal to or greater than an outer diameter of the outer sheath13. If there is a difference between the outer diameters of the capsule12and the outer sheath13, the connection between the capsule12and the outer sheath13may be uniformly tapered proximally so that there is no bump, recess, step or the like in or on those two outer surfaces. The outer sheath13may be configured to drive axial movement of the capsule12as required for the loading or release of the prosthetic valve3.

A circumferentially positioning fit is formed between the capsule12and the anchor14. The inner sheath15may drive circumferential movement of the anchor14, which may in turn cause the capsule12to move circumferentially as desired.

In specific implementations, since the inner sheath15is also coupled to the guide tip11, the latter will also move with the inner sheath15, while the outer sheath13still stays stationary, maintaining a three-dimensional configuration as required for positioning by the delivery catheter.

As shown inFIG.3, a prosthetic valve delivery device according to an embodiment of the present invention includes a handle2and a delivery catheter1coupled to the handle2. In implementations of the present invention, movement toward the delivery catheter1is defined as distal movement and that toward the handle2as proximal movement.

As shown inFIG.4, the handle2may be provided therein with an outer sheath actuation member21and an inner sheath actuation member22. The outer sheath actuation member21may be coupled to the outer sheath13in order to actuate axial movement of the outer sheath13, and the inner sheath actuation member22may be coupled to the inner sheath15in order to actuate circumferential rotation of the inner sheath15.

In specific implementations, the handle2may drive a bearing to move, thus resulting in circumferential rotation of the inner sheath actuation member22. As a result, the inner sheath15may rotate, causing the anchor14and the capsule12to rotate in concert therewith and thereby adjusting and aligning the prosthetic valve3with a native valve annulus. After that, the handle2may drive the bearing to move to cause axial movement of the outer sheath actuation member21. As a result, the outer sheath13drives the capsule12to move axially therewith relative to the inner sheath15, allowing loading and release of the prosthetic valve3.

Optionally, in embodiments of the present invention, the handle may be driven either electrically or manually.

In embodiments of the present invention, the circumferentially positioning fit between the capsule12and the anchor14may be accomplished by either of the following methods:

1. Engagement of an inner wall of the capsule12with an outer wall of the anchor14, as shown inFIG.5, which allows circumferential immobilization of the capsule12with respect to the anchor14. Specifically, as shown inFIGS.6to7, a protrusion or recess (C) may be provided on or in the inner wall of the capsule12, and a corresponding recess or protrusion that is complementary to the protrusion or recess on or in the inner wall of the capsule12may be provided in or on the outer wall of the anchor14.

Optionally, the protrusion and recess on and in the inner wall of the capsule12and the outer wall of the anchor14may have a square, triangular, circular, irregular or other shape. Additionally, one or more such protrusions and, correspondingly, one or more such recesses may be provided.

Optionally, in case of multiple protrusions and recesses being provided, they may be either of the same or different shapes and distributed circumferentially on and in the outer wall of the anchor14and the inner wall of the capsule12uniformly or not. Preferably, multiple protrusions and recesses are uniformly distributed circumferentially on and in the outer wall of the anchor14and the inner wall of the capsule12.

Although either of the capsule12and the anchor14may be provided with either of the protrusion(s) and recess(es) according to embodiments of the present invention, considering the capsule12has a relative small wall thickness, it is preferred that the protrusion(s) is/are provided on the inner wall of the capsule12.

2. At least one embedded section141is arranged in the outer wall of the anchor14, as shown inFIG.8, which has a friction force with the capsule12that is greater than a friction force between the prosthetic valve3and the capsule12so that a friction force generated between the anchor14and the capsule12is greater than a force for releasing or re-capturing the valve. By virtue of the friction force, the capsule12and the anchor14can rotate in concert with each other.

Specifically, one or more sections of a high coefficient of friction material may be embedded in the outer wall of the anchor14and have an outer diameter that may vary as required for fiction-based locking to the capsule12and unlocking therefrom.

Preferably, in the prosthetic valve delivery device, a coefficient of static friction between the embedded section141and the capsule12ranges from 0.1 to 1.5.

Further, as shown inFIG.9, the embedded section141may include a first strip unit1411and a second strip unit1412, with a first spring1421and a second spring1422connected therebetween.

Further, as shown inFIG.10, a pull thread142may be further included, which is arranged at joints143of the first and second strip units1411,1412and the first or second spring1421. Additionally, the pull thread142may be drawn through the inner sheath15and tied to the handle2.

Preferably, the pull thread142may consist of a single or multiple strands. Examples of the pull thread142may include, but are not limited to, a single solid metal wire or a thread consisting of multiple twisted metal strands. In implementations, the pull thread142may be axially pulled to change the outer diameter of the embedded section141.

As shown inFIGS.10to11, when the pull thread142is tightened, the first spring1421(or second spring1422) may be compressed, bringing the first and second strip units1411,1412of the embedded section141closer to each other. As a result, the anchor14may be separated from, and move independently of, the capsule12. As shown inFIGS.12to13, when the pull thread142is loosened, the first and second strip units1411,1412of the embedded section141may move outward and abut against the capsule12. As a result, the anchor14and the capsule12may be able to rotate in concert by virtue of a friction-based locking from the embedded section141.

Preferably, in the prosthetic valve delivery device, the first and second strip units1411,1412are arranged in symmetry with respect to an axis of the outer wall of the anchor14. This facilitates connection of the pull thread142to all the embedded section(s) on a single side.

Optionally, the capsule12may be connected to the outer sheath13by a bearing or an elastic material. Examples of the elastic material may include, but are not limited to, silicone materials, PU materials, Pebax nylon elastomers (engineering polymers), etc. Preferably, the capsule12may be connected to the outer sheath13by a bearing, which allows free circumferential rotation therebetween. Alternatively, the capsule12may be connected to the outer sheath13by a spring or elastic material. In this case, circumferential rotation between the capsule12and the outer sheath13is only possible within an angular limit that depends upon the properties of the spring or elastic material.

According to embodiments of the present invention, the handle2may be manipulated to drive axial movement of the bearing and hence the outer sheath actuation member21, which causes axial movement of the outer sheath13and hence the capsule12with respect to the inner sheath15, thus allowing loading and release of the prosthetic valve3. In addition, the handle2may be also manipulated to drive circumferential rotation of the bearing and hence the inner sheath actuation member22, which causes the anchor14and the capsule12to rotate in concert with each other with the rotation of the inner sheath15. In this way, the adjustment of the angle for releasing the prosthetic valve3can be achieved, thereby allowing precisely releasing the prosthetic valve3.

Optionally, the outer sheath13may be a controllable bending tube, such as a polymer tube or a composite metal-polymer tube. In implementations, the outer sheath13may be a polymer tube with metal structure arranged in or on the inner surface thereof. The outer sheath13may be embedded therein with at least one metal wire, and controlling of bending angle, position and direction of the outer sheath13by pulling different metal wires. Preferably, multiple metal wires are embedded in the controllable bending tube in order to improve precision of the controlled bending.

Optionally, the inner sheath15may be a single-lumen tube or a multi-lumen tube. Preferably, the inner sheath15is a multi-lumen tube because in addition to the pull thread142, a guide wire is also intended to be threaded through the inner sheath15. In this case, the multi-lumen tube can provide separate channels for the pull thread142and the guide wire so that they can perform their own intended functions without affecting each other.

According to embodiments of the present invention, a process of loading the prosthetic valve may involve: retracting the capsule12by manipulating the handle2until a leading end of the capsule12is located behind the anchor14so that the anchor14is exposed; attaching the self-expanding prosthetic valve3to the anchor14; and upon stabilization of the prosthetic valve3, causing the outer sheath13to move forward until the prosthetic valve3is completely housed in the capsule12, with its leading end abutting against the guide tip11.

According to embodiments of the present invention, a process of delivering the prosthetic valve may involve: introducing the entire prosthetic valve delivery device over the guide wire into a patient's body via a puncture made therein; and delivering the capsule12with the prosthetic valve3crimped therein, through a path passing through the femoral vein and the atrial septum, to the diseased native valve annulus.

According to embodiments of the present invention, a process of releasing the prosthetic valve may involve: controlling the bending through the outer sheath13, and when completing the adjustment, the outer sheath13is immobile; circumferentially rotating the inner sheath15by manipulating the handle2so that the anchor14and capsule12rotate in concert with each other with the rotation of the inner sheath15, thereby adjusting the relative position between the prosthetic valve3and the native valve annulus so as to ensure good conformance of the prosthetic valve3to the native valve annulus; and upon the prosthetic valve3being circumferentially adjusted to the desired angular position, proximally moving the outer sheath13and hence the capsule12in the axial direction by manipulating the handle2until the prosthetic valve3is completely detached from the delivery device and released to a predetermined position.

Preferably, in embodiments of the present invention, the release of the prosthetic valve3may be suspended at any desired time to allow an additional positioning adjustment by circumferentially rotating the inner sheath15. This facilitates real-time alignment and precise release of the prosthetic valve3.

In summary, according to embodiments of the present invention, the capsule12may both axially move under actuation of the outer sheath13concurrently with the anchor14being kept stationary, and circumferentially rotate in concert with the anchor14under actuation of the inner sheath15, concurrently with the outer sheath13being kept stationary. This is advantageous in allowing the capsule12to circumferentially move in concert with the anchor14and independently of the axial movement, and to move axially under actuation of the outer sheath13and independently of the circumferential movement.

According to embodiments of the present invention, with the delivery device being maintained in an overall configuration in which the outer sheath controls the bending in a desired manner, circumferential movement of the prosthetic valve is possible, thus allowing precise release of the prosthetic valve even if it has an irregular cross sectional shape.

While the fundamental principles, main features and advantages of the present invention has been presented and described above, it will be appreciated by those of ordinary skill in the pertinent art that the present invention is not limited to the embodiments disclosed hereinabove, which, together with the above description, serve to explain the principles of the present invention, and various changes and modifications can be made to the present invention without departing from the spirit or scope of thereof. Accordingly, all such changes and modifications are intended to also fall within the scope of the present invention as defined by the appended claims and equivalents thereof.