阅读说明：本技术 经导管假体心脏瓣膜的递送系统 (Delivery system for transcatheter prosthetic heart valve ) 是由 E·帕斯奎诺 M·斯克森 A·马尔基西奥 L·瓦莱里奥 S·帕斯奎诺 于 2018-03-01 设计创作，主要内容包括：一种用于可自扩张心脏瓣膜假体(29)的经导管递送系统,其包括手柄(17,17’)、中空轴(6)、远侧末端(1,1’,1”’)或用于朝向远侧末端(1,1’,1”’)或手柄(17,17’)移动瓣膜假体(29)的致动机构,中空轴(6)适于滑动地接纳压缩的瓣膜假体(29)；该系统的特征在于,系统包括瓣膜假体卷曲工具,瓣膜假体卷曲工具包括中空的圆锥形元件(21)、可拆卸的传递管(24)和牵拉装置(26)；圆锥形元件(21)适于让处于扩张状态下的瓣膜假体(29)通过其基底进入圆锥形元件(21)并且处于压缩状态下进入传送管(24),瓣膜假体(29)在横跨圆锥形元件(21)并进入传送管(24)时通过牵拉装置(26)牵拉,传送管(24)适于临时连接到圆锥形元件(21)。(A transcatheter delivery system for a self-expandable heart valve prosthesis (29), comprising a handle (17,17 '), a hollow shaft (6), a distal tip (1, 1', 1 "'), or an actuation mechanism for moving the valve prosthesis (29) towards the distal tip (1, 1', 1" ') or the handle (17, 17'), the hollow shaft (6) being adapted to slidingly receive a compressed valve prosthesis (29); the system is characterized in that it comprises a valvular prosthesis crimping tool comprising a hollow conical element (21), a detachable delivery tube (24) and pulling means (26); the conical element (21) is adapted to let the valve prosthesis (29) in an expanded state enter the conical element (21) through its base and in a compressed state into the delivery tube (24), the valve prosthesis (29) being pulled by the pulling means (26) when crossing over the conical element (21) and entering the delivery tube (24), the delivery tube (24) being adapted to be temporarily connected to the conical element (21).)

1. A transcatheter delivery system for a self-expandable heart valve prosthesis (29), the system comprising a handle (17,17 '), a hollow shaft (6), a distal tip (1, 1', 1 "'), and an actuating mechanism for moving the valve prosthesis (29) towards the distal tip (1, 1', 1" ') or the handle (17, 17'), the hollow shaft (6) being adapted to slidingly receive a compressed valve prosthesis (29); the system is characterized in that it comprises a valvular prosthesis crimping tool comprising a hollow conical element (21), a detachable delivery tube (24) and pulling means (26); the conical element (21) is adapted to let the valve prosthesis (29) in the expanded state enter the conical element (21) through its base and in the compressed state into the delivery tube (24), the valve prosthesis (29) being pulled by the pulling means (26) when crossing the conical element (21) and entering the delivery tube (24), the delivery tube (24) being adapted to be temporarily connected to the conical element (21).

2. The delivery system of claim 1, further comprising a delivery tube securing cap (25) adapted to be temporarily connected to the delivery tube (24).

3. The delivery system according to any of the preceding claims, further comprising a valve cover 5 located between the hollow shaft (6) and the distal tip (1,1 ").

4. The delivery system according to any of the preceding claims, wherein the distal tip is made of a soft elastic material (1,1 "').

5. The delivery system according to any of the preceding claims 1 to 3, wherein the distal tip is an inflatable balloon (1 ").

6. The delivery system according to any one of the preceding claims, further comprising a stopper (8) adapted to retain the valve prosthesis (29) within the shaft (6).

7. The delivery system according to any of the preceding claims, further comprising a clearing system (1', 20).

8. The delivery system of any of the preceding claims, wherein the actuation mechanism is a mechanical actuation mechanism or an electrical actuation mechanism.

9. The delivery system of any of the preceding claims 1 to 7, wherein the actuation mechanism is a hydraulic actuation mechanism.

10. The delivery system according to any of the preceding claims 1 to 7, wherein the actuation mechanism is a hybrid actuation mechanism, i.e. mechanical, electrical and hydraulic.

11. A crimping tool (21,24,25,26) for a delivery system according to any of the preceding claims.

12. The crimping tool of claim 11, comprising a delivery tube (24) sized to receive a compressed prosthesis (29) such that it can be loaded into the delivery system from both an atrial side and a ventricular side in preparation for an antegrade or retrograde implant procedure.

13. A stopper (8) for a delivery system according to any one of the preceding claims 1 to 10.

14. A valve cover (5) for a delivery system according to any of the preceding claims 1 to 10, realized in a very thin, flexible, radially non-compliant polymer material, which delivery system is to be implemented in particular in an antegrade delivery system; a valve cover with variable thickness has a thicker section from its distal edge where the radiopaque ring is placed and where a good fitting with a rigid tip or balloon tip is required.

15. The valve cover (5) according to claim 14, having a discontinuous thickness, e.g. stepwise or piecewise from its proximal to its distal portion.

Technical Field

The present invention relates to transcatheter delivery of a self-expandable heart valve prosthesis.

Background

The heart valve prosthesis replaces the native valve function. They open and close during the cardiac cycle, directing blood flow through the heart chamber and out to the rest of the body. Semilunar valves (aortic and pulmonary) are skin valves of the endocardium and connective tissue reinforced with fibers, which prevent the valve from rolling out. They are shaped like a half-moon and are therefore named "half-moon". The semilunar valve is located between the aorta and the left ventricle, and between the pulmonary artery and the right ventricle. In contrast, atrioventricular valves (mitral and tricuspid valves) are thin structures composed of the endocardium and connective tissue. They are located between the atria and ventricles. The mitral valve represents an anatomical feature that regulates the blood pathway between the left atrium and left ventricle. It prevents blood in the ventricle from returning to the atrium and consists of two triangular petals attached at their bases to an annulus fibrosus, which surrounds the opening and is connected at its edges to the ventricular wall by chordae tendineae and papillary muscles.

The main problem associated with mitral valve injury is stenosis or insufficiency of the valve. Deficiencies can lead to leakage of blood back through the mitral valve each time the left ventricle contracts, and ultimately lead to mitral regurgitation. In particular, a leaking mitral valve allows blood to flow in both directions during systole. Some blood flows from the ventricles through the aortic valve-as it should happen-and some blood flows back into the atria. Leakage can increase the volume and pressure of blood in this region. Increased blood pressure in the left atrium can increase pressure in the veins leading from the lungs to the heart (pulmonary veins). In addition, if the reflux is severe, the increased pressure may cause pulmonary congestion (or fluid accumulation). Solutions have been developed to restore correct valve coaptation and are included in the treatment of surgical valve annuloplasty or leaflet prolapse. In order to reduce the burden of open-chest surgical procedures, non-invasive repair techniques have recently been introduced. In addition to this approach initially helping to reduce valve insufficiency, several studies reported as a benefit of this technique are not superior to traditional mitral valve surgery, requiring a later re-surgery on several patients. These results underscore the need to develop an entire prosthetic valve that can replace the entire native functional element with a non-invasive implantation procedure. Although solutions have been proposed to replace the native aortic valve with a percutaneous transcatheter prosthetic valve, the unique positioning and hemodynamic characteristics of the mitral valve have heretofore hindered this implantation approach. In order to deploy self-expandable valves via a transcatheter approach, specific delivery systems have been developed.

The development of self-expandable valves allows the valve structure to be crimped to a cylindrical shaft before the valve is deployed in the correct anatomical location. Furthermore, several delivery systems allow 1) charging the valve in a very precise manner within the shaft of the delivery system without too much traction force that would damage the stent structure and with evenly distributed forces to prevent overlap of the stent structure; and 2) the possibility of recapturing the prosthesis in the shaft if the release position is incorrect or the process has to be aborted for any reason. An example of such a system is disclosed in us patent application 2015/0173895a 1.

Since displacement of the valve prosthesis from the correct anatomical position may lead to several fatal complications (such as permanent paravalvular leaks) or even dislodgement of the valve from the implantation site, it is extremely important to reach and match the native anatomical annulus before releasing the valve. The operating mechanisms of the delivery systems on the market rely mainly on mechanical solutions. Typically, a series of inner and outer catheters allow for pushing and deploying the valve. The rotary crank operated by the physician has the advantage of ensuring perfect control of the speed during deployment, since each motion is transmitted directly to the shaft, allowing tactile feedback and absolute control of the force required to release the prosthesis. However, during loading of the collapsed prosthesis in the delivery system, relative movement between these rigid structures may occur. Such systems are not ideal because they are time consuming and small variations in the loading phase can occur, resulting in uneven stent distribution inside the shaft, mainly if the stent shape is asymmetric. This aspect can have significant consequences because the prosthesis may be released asymmetrically and not properly positioned during surgery.

Delivery systems with hydraulic motion for deploying vascular stents have been introduced (US6,514,264; and US5,728,065; US4,811,737). In addition to a complex structure and comprising several structural elements that may include possible critical issues, such devices introduce an interesting solution involving the fluid pressure provided by a syringe-like actuator to release the stent into position. Despite the apparent need to simplify and improve this concept, its advantages for proper deployment through a catheter appear elusive, since an interface is introduced between the operator and the prosthesis that may impair absolute control during deployment. However, the main characteristics of the hydraulic system (i.e. low friction, evenly distributed mechanism and discomfort if higher forces are required) will have a great advantage over mechanical delivery systems during the loading phase of the prosthesis and whenever restoration of the valve is required. It is essential that the delivery system must allow loading and release of the valve in the correct position, which means high safety and reliability of the device during surgery. Furthermore, when needed, the system should allow for valve recovery prior to final release.

As regards the actuation mechanism, it may consist of at least different types of actuation systems, irrespective of the access route to be used. (a) The mechanical delivery system includes a ring that rotates on a crank. It has a release speed during loading and deployment of the prosthesis, which depends on the distance between the threads of the crank. (b) The hydraulic delivery system has a bi-directional mechanism. One inlet for deploying the prosthesis and one outlet for loading/retrieving the prosthesis. (c) The third operating system is based on a synergistic combination of the two systems. The associated hydraulic means used during the loading/retrieval phase are associated with the mechanical means used during the deployment phase of the prosthesis, or vice versa. Thus, the procedural flow for transcatheter valve implantation is optimized.

The implantation process of transcatheter valve prostheses requires collapsing the prosthesis for loading into a delivery system. The crimping process of the prosthesis is performed using a specifically designed number of accessory tools.

Disclosure of Invention

The present invention comprises an improved delivery system that allows for positioning and deployment of a heart valve prosthesis, particularly an atrioventricular prosthesis, via a transcatheter approach. The delivery system includes a crimping tool that reduces the diameter of the prosthetic valve. The prosthesis is compressed so that it can be loaded into a valve cover of a delivery system.

The present invention more precisely relates to a transcatheter delivery system for a self-expandable heart valve prosthesis, comprising a handle, a hollow shaft, a distal tip and an actuation mechanism for moving the valve prosthesis towards the distal tip or the handle, the hollow shaft being adapted to slidingly receive a compressed valve prosthesis; the system is characterized in that it comprises a valvular prosthesis crimping tool comprising a hollow conical element, a detachable delivery tube and pulling means; the conical element is adapted to let the valve prosthesis in an expanded state enter the conical element through its base and in a compressed state into the delivery tube, the valve prosthesis being pulled by the pulling means while traversing the conical element and entering the delivery tube, the delivery tube being adapted to be temporarily connected to the conical element during a crimping process and disconnected therefrom during a subsequent loading process.

The delivery system according to the invention is preferably designed to allow prosthesis access via the left ventricle in transapical access (retrograde), via the left atrium in transarterial access (antegrade), or alternatively via the femoral vein and transseptal puncture (antegrade) from the right atrium to the left atrium.

Drawings

The invention will be better understood in this section, examples of which are illustrated by the following drawings:

FIG. 1A first example of a delivery system distal end (tip) for an antegrade delivery system according to the present invention

Fig. 1.1 a second example of a distal end (tip) of a delivery system represented by a balloon for a retrograde delivery system according to the invention

Fig. 1.2 a third example of a distal end (tip) of a delivery system for a retrograde delivery system according to the present invention

FIG. 2 example of a valve cover with its components to hold a collapsed prosthetic valve

Fig. 3 shows a first example of a stopper to be placed inside the valve cover. Prosthesis whose function is to maintain crimping during a retrograde implantation procedure

FIG. 3.1 second example of a stop to be placed inside the valve cover, showing an anchoring system for the anterior and posterior coaptation arms

FIG. 3.2 third example of a stop to be placed inside the valve cover, showing an anchoring system for the anterior coaptation arm

Fig. 4 shows a first example of a stopper to be placed inside the valve cover. Prosthesis whose function is to maintain collapse during an antegrade implantation procedure (lateral view)

Fig. 4.1 a second example of a stop to be placed inside the valve cover for delivery used during an antegrade implantation procedure (front view)

Fig. 4.2 a third example of a stop to be placed inside the valve cover for delivery (side and front views) used during the antegrade implantation procedure

FIG. 5 first example of a hydraulic delivery system for a retrograde implant procedure

FIG. 5.1 second example of a hydraulic delivery system for retrograde implantation procedure (valve cover separated from shaft)

FIG. 5.2 third example of a hydraulic delivery system for retrograde implantation procedure (valve cover integrated with shaft)

FIG. 6A first example of a mechanical delivery system for a retrograde or anterograde implantation procedure

FIG. 6.1 second example of a mechanical delivery system for retrograde or antegrade implantation procedure (structural details)

FIG. 6.2A third example of another type of mechanical delivery system for an antegrade implant procedure

FIG. 6.3A fourth example of another type of mechanical delivery system for an antegrade implant procedure (structural details)

FIG. 6.4A fifth example (structural details) of another type of hydraulic delivery system for an antegrade implantation procedure

FIG. 7 handle of hydraulic delivery system (close-up view)

FIG. 7.1 handle of Hydraulic delivery System (full view)

FIG. 8 first example of a circular conical crimping element

FIG. 9A second example (side view) of a circular conical curling element

FIG. 10A third example of a circular conical curling element (front or inset side view)

FIG. 11 a fourth example of a D-shaped conical crimping tool with internal grooves

FIG. 12 is a fifth example of a D-shaped conical crimping tool with internal grooves (front view)

FIG. 13 shows a sixth example of a D-shaped conical crimping tool with different types of internal flutes (front view)

FIG. 14 is an eighth example of a D-shaped conical crimping tool having different internal grooves (front view)

FIG. 15 transfer tube

FIG. 16 transfer tube cover

Fig. 17 first example of a pulling device

FIG. 18 second example of a pulling device mounted on a valve prosthesis

FIG. 19 third example of a pulling device mounted on a valve prosthesis

FIG. 20 fourth example of a pulling device mounted on a valve prosthesis

FIG. 21 holding jig

FIG. 22 threaded locking cap

FIG. 23 illustrates a sequence for loading a prosthesis into a crimping tool and transferring the final crimping process into a delivery tube

FIG. 24 delivery tube after crimping procedure with collapsed prosthesis inside

FIG. 25 Process of Loading a collapsed prosthesis into a delivery System

Reference numerals used in the drawings

1. Delivery system distal tip for a delivery system for a retrograde implantation procedure

Debubbling purge hole for delivery system

Sealing balloon acting as tip

A delivery system distal tip for a delivery system for an antegrade implantation procedure

2. Conical part of the tip

3. Gasket for sealing a tip to a delivery shaft

4. Inner cavity of tip (guide wire inner cavity)

5. Delivery shaft valve cover

Distal edge of delivery shaft with radiopaque marker

Radiopaque markers on delivery shaft

6. Delivery shaft

7. Spacer inside delivery shaft to avoid shaft kinking

8. Valve retaining element or stop for retrograde delivery system

Valve retaining element or stop for an antegrade delivery system

9. A convex crank screwed into the threaded concave part of the tip

9' threaded female part of the tip

10. Inner shaft of delivery system (which contains guide wire during implantation procedure)

Radiopaque tip of inner shaft

11. Front anchoring element of a stop

12. Rear anchoring element of a stopper

13. First example of an anchoring pin for an atrial valve of a prosthesis on a stopper of an antegrade delivery system

A second example of an anchoring pin for an atrial valve of a prosthesis on a stopper of an antegrade delivery system

A stopper slot for an antegrade delivery system to receive a prosthetic atrial valve

14. Slot for release lock control in hydraulic delivery system

Ring acting as a lock control in a mechanical delivery system

15. Release lock control

16. System safety lock

17. First example of a delivery System handle

Second example of a delivery System handle

18. First example of an activation trigger in a mechanical delivery system

18' second example of an activation trigger in a mechanical delivery system

19. Rotary ratchet in mechanical delivery system to achieve good rotational orientation of prosthesis during deployment

20. Proximal ports for guidewire access and fluid injection (radiopaque media, etc.)

21. Conical crimping element for collapsing a prosthesis

22. Quick connect system

23. Slots inside circular and D-shaped conical crimping elements

24. Conveying pipe

Anchoring pin on transfer tube

25. Conveying pipe fixing cap

26. Traction device

27. Holder part of a pulling device

28. First example of a rigid element of a pulling device

Anchoring system at distal end of pulling device

29. Examples of valve prostheses

30. Second example of a rigid element of a pulling device

31. Third example of a rigid element of a pulling device

32. Retaining clip for retaining a prosthesis engagement arm during prosthesis loading for retrograde delivery system procedures

33. Threaded locking cap to hold atrial flange flap of prosthesis closed during prosthesis loading for retrograde delivery system procedures

34. Posterior joint arm of prosthesis

35. Anterior joint arm of prosthesis

Detailed Description

Delivery system

The delivery system preferably uses a hydraulic (fig. 5), mechanical (fig. 6, 6.1, 6.2, 6.3), electric or hybrid (hydraulic and mechanical motion systems together) actuation mechanism.

In these different actuation mechanisms, several features remain equal (tip, valve cover, and shaft). The delivery system comprises a proximal elongated structure 17, called handle (which comprises an actuating mechanism for deploying the prosthesis), and a distal structure consisting of, on the distal side in the proximal direction, a tip 1, 1' and 1 "(fig. 1, 1.1 and 1.2), a valve cover 5 (in which the valve is loaded before release into the heart) and a transparent shaft 6 (fig. 2, 5, 5.1, 5.2, 6, 6.2, 6.3, 6.4). In one embodiment (fig. 5.2), the valve cover 5 is integrated into the shaft 6. The most distal part of the system is equipped with a soft polymer tip 1,1 'or balloon tip 1'. The inner metal tube 10 is guided inside the system (fig. 7), which allows the introduction of a guide wire used during the implantation procedure and allows the flushing fluid.

The four main components in turn constitute a delivery system as described in figures 2, 5, 5.1, 5.2, 6, 6.2, 6.3, 6.4:

distal tips 1,1 "and 1"',

a valve cover 5 and a valve retaining element 8 called a stop,

-a shaft (6) for rotating the shaft,

a handle 17, which receives moving parts (e.g. a hydraulic, mechanical, electric or hybrid drive system), different proximal ports 20, a prosthesis release lock control 15 engaged in the slot 14 (during the implantation procedure) and a system safety lock 16 that prevents the valve from being released undesirably (before starting the prosthetic valve deployment).

Delivery tip, stop and valve cover

On the distal end (fig. 1), the delivery system is provided with a conical soft tip 1 made of a flexible polymer material (silicon or polyurethane or other biocompatible polymer eventually loaded with radiopaque material).

The soft tips 1,1 "' can be anchored to the metal or polymer substrate 2, which metal or polymer substrate 2 must fit and seal against the valve cover 5. The seal is obtained by a gasket 3 located at the bottom of the base 2. In the soft tip 1, a purge hole 1' is formed to allow air bubbles to be discharged during a purge process.

The soft tip is mounted on a delivery system which inserts it over an inner shaft 10 which is withdrawn from the lumen 4 (fig. 1, 1.2). The proximal concave portion of the tip 9' is screwed onto a crank 9 (fig. 2) placed on the inner shaft 10 of the delivery system. After the prosthesis is loaded, the delivery tip perfectly seals the valve cover 5 by means of the gasket 3 (fig. 1, 1.2).

Before starting the implantation process, the tips 1,1 "' allow sealing of the valve cover 5 so that the process of removing air bubbles with sterile saline solution can be completed. Saline solution is injected from a proximal port 20 placed at the bottom of the handle 17 in order to purge air bubbles from the valve cover 5 through the small holes 1' (from 2 to 4) in order to avoid the risk of air embolism during deployment of the bioprosthetic valve.

The shape and softness of the tip 1,1 "' is particularly important during the implantation process. It allows the delivery system to gently and smoothly enter the heart chamber (atrium or ventricle) across the myocardial wall without damaging the myocardial wall.

In one embodiment (fig. 1.1, 6.2, 6.3), which may be advantageously used for antegrade implant access (either transatrial or transseptal), the distal portion of the delivery system has a shape of the balloon 1 similar to the balloon 1 "used for angioplasty catheter procedures. The balloon tip is expanded with a radiopaque medium prior to surgery. When expanded, it allows a perfect sealing of the tip on the valve cover 5, preventing the entry of air bubbles, and leaving the distal portion of the delivery device atraumatic while passing through anatomical structures such as the ventricles, atria and interatrial septum. The use of a balloon tip on the distal portion is extremely important for an antegrade approach, as the tip can be collapsed after valve deployment during delivery of the valve, avoiding any possible entrapment of the valve leaflets.

Prior to implantation, the prosthetic valve is collapsed down with a special crimping tool and loaded into a valve cover 5 (fig. 2, 5, 5.1, 5.2, 6, 6.2, 6.3, 6.4) located on the distal portion of the delivery system. It consists of a cylindrical chamber, usually made of a thin but rigid polymeric and transparent material, sufficient to accommodate the radial forces of the collapsed prosthesis with minimal deformation. In an alternative embodiment, the valve cover may still be rigid, but realized in a metal alloy, in order to keep it very thin. In another inventive solution, the valve cover can be realized in a very thin (e.g. thinner than 100 μm), flexible and radially non-compliant polymer material (similar to balloon angioplasty catheters); this valve cover may have a variable thickness with a thicker section from the distal edge where the radiopaque ring is placed and where a good fitting with a rigid tip or balloon tip is required. The thin and flexible valve cover is particularly suitable for transseptal antegrade delivery systems where there is steering of the delivery shaft. During the implantation process, the valve cover is retracted to deploy the valve, and if the valve cover is thick and rigid, it can interfere with the regular deployment of the prosthesis. Thus, the thin and flexible valve cover avoids any interference with the proximal portion of the delivery shaft in which steering is present during the deployment process. The thickness and flexibility of the valve cover may be continuous or discontinuous; may vary from proximal to distal portions of the valve cover and in any other combination, stepwise or in sections. The radiopaque markers 5' are positioned circumferentially and radially along the valve cover 5, allowing for proper orientation and positioning of the valve during implantation. In order to hold the prosthesis safely within the valve cover 5, the prosthesis is anchored to a holder called a stopper 8 (fig. 2).

When the valve is loaded, the stop 8 is positioned at the proximal end of the valve cover 5 and it is mounted on the inner shaft 10 of the delivery system across all delivery lengths (fig. 2).

The inner shaft 10 is a metal tube that passes through all delivery systems from its distal end to its proximal end. The distal portion 10' is made of a radiopaque material so that the maximum protrusion delivered is always known during the implantation procedure (fig. 2). On the distal part of the shaft 10 there is also a crank 9, on which crank 9 the end 1,1 "' is screwed through the female thread 9.

The stop design varies depending on the antegrade or retrograde type of implant portal (fig. 3, 3.1, 3.2, 4, 4.1, 4.2).

The stop 8 has the function of retaining the prosthesis in the valve cover 5 during the loading phase. It also has the function of preventing the prosthesis from jumping out of the valve cover before the prosthesis deployment is completed.

For the left ventricular transapical method (retrograde), the valvular prosthesis is held to the stopper 8 by specially designed anchoring elements 11 and 12 that anchor the ventricular part (outflow side) of the prosthesis to the stopper. In particular, the stop represented here is designed with two different opposite anchoring elements 11,12 (fig. 3, 3.1, 3.2). The shape and number of the anchoring elements depends on the presence of the front steering engagement arms or the rear steering engagement arms on the prosthetic stent. Two pin elements 12 (fig. 3, 3.1) are dedicated to anchoring the posterior ventricular coaptation arms of the prosthesis (when the valve is deployed, the coaptation arms are flipped up to almost 180 ° to grasp the posterior native mitral leaflet). The opposite pin with flat portion 11 (fig. 3, 3.1, 3.2) present on the stop 8 is dedicated to anchoring the anterior ventricular coaptation arm of the prosthesis (which can be flipped up to 180 ° to catch and block the anterior native mitral leaflet when the valve is deployed). The two different anchoring pins 11 and 12 are specifically designed to hold the valve prosthesis when the valve-engaging arms are in a flat position after the bioprosthesis has been crimped.

The stop 8 is realized in a corrosion-resistant material, such as a metal alloy (stainless steel, titanium, etc.), obtained by machining or by laser synthesis of metal powders or other techniques. In the alternative, it may be achieved by molding, laser synthesis or machining of a highly corrosion resistant polymer.

In order to keep the front engaging arm flat, the stop is provided with an extension element 11 (fig. 3, 3.1, 3.2).

The anterior extension element of the stop also allows the operator to identify the anterior side of the valve cover endoprosthesis under X-ray imaging during the implantation procedure.

In the case of the transatrial or transseptal approach or the so-called antegrade approach, the stopper 8 is provided with eight pins 13 (typically 6 to 12) allowing the prosthesis to engage into specific holes present on the atrial flange of the prosthesis (inflow side of the prosthesis) (fig. 4, 4.1, 4.2).

Delivery shaft

Delivery shaft 6 is one of the features that remain equal in the different delivery systems described herein. It consists of a biocompatible and possibly transparent tube connecting the handles 17,17 with the valve cover.

The delivery shaft 6 must be relatively flexible, ultimately steerable at different angles depending on the implantation procedure (retrograde or antegrade) employed, provided with longitudinal and/or circumferential radiopaque markers 5' to guide the operator during the implantation procedure (fig. 2, 5, 5.1, 5.2, 6, 6.1, 6.2, 6.3, 6.4).

The longitudinal marker 5 "allows for proper alignment of the crimped prosthesis relative to the longitudinal radiopaque marker line during loading and is mandatory for proper positioning during implantation.

A circumferential radiopaque marker 5' is placed at the distal end of the valve cover. It is a ring of radiopaque metal or paint (tantalum, tungsten or other similar radiopaque metal) embedded in the polymeric material of the valve cover 6. This marker 5 allows the operator to assess the position of the distal end of the valve cover during the implantation procedure.

The shaft 6 is connected to the valve cover 5 by means of a connecting element (fig. 5.1), or the shaft and the valve cover are obtained from a single piece of tube (fig. 5.2, 6, 6.2, 6.3, 6.4). This second embodiment completely avoids possible discontinuities between the connecting parts, making the system smoother and easier to manufacture.

To enhance the ease of valve deployment during the implantation procedure, the outer surface of the shaft 6 may be coated with a hydrophilic material.

Handle (CN)

The handle 17 controls the loading and deployment of the prosthesis before and during the procedure. Different handle systems may be used for mechanical, hydraulic or hybrid systems, respectively.

In one embodiment, the mechanism for loading and deploying the valve is hydraulic (fig. 7). A hydraulic system solution may consist of a hydraulic piston used by a compression chamber (fig. 7.1) that allows movement of the stopper 8 through the valve cover 6 (fig. 5.1, 5.2, 6.4).

In another embodiment (fig. 6), the actuation mechanism for loading and deploying the valve is mechanical. The mechanical solution consists of a rack motion system (fig. 6.1) that allows the stopper 8 to move through the valve cover 6.

The handle of the mechanical delivery system features a handle 17' and an activation trigger 18, which activation trigger 18 moves the shaft back and forth during the deployment and loading process of the prosthesis. As described for the hydraulic delivery system, the mechanically operated handle is also provided with different ports 20 for clearing and introducing the guide wire, a prosthesis release control 15 (during the implantation procedure) and a system safety lock 16 to prevent unwanted release of the valve (prior to the implantation procedure).

Another example of a mechanical delivery system is shown in fig. 6.2 and 6.3. This movement is imparted by an endless screw which is in direct continuation of the handle 17, the knob 18 being turned onto the handle 17. Release lock control is obtained by means of the positionable ring 14'. The mechanical movement (rather than manual control) may also be actuated by a linear motor.

In another embodiment, the actuation system is hybrid and uses the mechanical motion described above to load the valve into the delivery system and hydraulic motion to place the valve in place, or vice versa.

The handle is provided with two different buttons or switches intended to safely control the implantation procedure (prosthesis release control 15 and system safety lock 16).

A prosthesis release control 15 (fig. 5, 5.1, 5.2) is located at the distal end of the hydraulic handle and allows precise control of the deployment process to release the valve at predetermined steps. The release control mechanism is designed to deploy the valve prosthesis at specific and predetermined steps. In mechanically actuated systems, the prosthesis release control is placed on the upper part of the handle 17' (fig. 6, 6.1).

In one embodiment, a system safety lock 16 (fig. 5) is located at the proximal end of the hydraulic delivery system and the proximal end of the mechanical delivery system (fig. 6, 6.1, 6.2, 6.3). Which hinders any undesired accidental release of the prosthesis before the correct positioning is obtained.

In another embodiment (fig. 6, 6.1), actuation of the rotary ratchet 19 allows a rotational movement of the valve cover.

The handle 17, 17' may also be equipped with one or two hub connections. One was placed at the proximal end of the handle and allowed access to the guidewire and lumen (fig. 5,6, 6.1, 6.2, 6.3, 6.4) flushed with saline or contrast. The second is to group three different pressure lines dedicated to the loading, release and purge of the entire system. This second hub connection is placed on the handle 17, 17' and allows for the ingress of liquid, thereby ensuring movement of the piston (for the hydraulic handle) and also allowing for the clearing process to be performed prior to implantation of the valve.

The second hub connection can also be positioned on the handle for mechanical solutions (fig. 6, 6.1). In this solution, the hub connection only allows for a clearing process prior to implantation of the valve.

All four versions of the actuation system provide the possibility to perform a purging of the air bubbles of the delivery system before their introduction in the heart. This mechanism prevents the introduction of unwanted air-bubble emboli in the circulatory system, leading to the occurrence of potentially dangerous cerebrovascular accidents.

Crimping tool

As previously mentioned, the crimping tool is designed to collapse the prosthetic valve within the system and more precisely within the valve cover 5.

The same crimping tool can be used with all four types of delivery systems (mechanical, electrical, hydraulic, and hybrid).

The three main parts constitute the crimping tool.

The first part is constituted by a conical crimping element 21 (fig. 8-14), which conical crimping element 21 reduces the valve diameter from the unexpanded size to the crimped size (which is a different size).

The conical crimping element 21 can be internally smooth (figures 9, 10) or internally machined to obtain several grooves 23 along its length, so as to adapt the anchoring system of the prosthesis (figures 11 to 14).

In other embodiments, the conical crimping element may have a D-shape or a circular shape, with the internal profile varying at different lengths. Conical crimping element 21 terminates at one side with a quick connect system 22 (fig. 8) for connection with a delivery tube 24.

The second part is made of two elements: a cylindrical tube member referred to as transfer tube 24 (fig. 15) and a transfer tube retaining cap 25 (fig. 16). The transfer tube 24 is connected at the conical crimping element from one side via two or more pins 24' and from the other side to a transfer tube securing cap 25.

In another embodiment (not shown), the second portion consists only of the delivery tube, i.e. without a securing cap.

The third main part consists of a pulling device 26 (fig. 17), which pulling device 26 is used to pull the valve through the conical crimping element 21, the delivery tube 24 until the securing cap 25 is reached. The pulling device consists of a metal or plastic support from which two to eight rigid elements 28 come out, said rigid elements 28 having an anchoring system at the distal end 28'. The pulling means has a retainer portion 27 to allow the operator to pull the prosthesis during the crimping process.

In one embodiment, the pulling means 26 comprise hooks 28' to hold the prosthesis at the level of the atrial flange (fig. 17). Alternatively, the distraction device 26 has a specific retention system designed to make the device easier to load and release from the prosthesis during the crimping process.

In other embodiments, the pulling device 26 serves as a pulling retainer system 30 and 31, the pulling retainer system 30 and 31 capturing the yarn through a hole placed at the proximal end of the prosthetic atrial flange 29 of the prosthesis (fig. 18, 19, 20). This anchoring scheme is applicable to all implants performed by both antegrade and retrograde procedures in the preparation of the crimp. In effect, crimping the prosthesis within the delivery tube, pulling the prosthesis out of the atrial flange, allows the prosthesis to be loaded into a delivery system for both antegrade and retrograde procedures.

The pulling means may also be anchored to the prosthesis 29 by means of solid and flexible threads or straps 30 which grip the atrial flange of the prosthesis 29 (fig. 18).

As another example, the pulling means may capture a valve holder element fixed at the atrial side of the prosthesis (fig. 19) by a yarn 31 anchored in a hole at the proximal end of the prosthetic atrial flange 29.

A substantially modified identical pulling device 26 is attached to the atrial flange of the prosthesis 29 by a rigid element 28 (fig. 20).

Additional tools required for the prosthesis crimping process are a retaining clamp 32 (fig. 21) and a cylindrical threaded locking cap 33 (fig. 22).

Crimping process

The crimping process is depicted in fig. 23. The pulling device 26 is inserted into the conical crimping element 21 previously fitted together with the delivery tube 24 and the delivery tube securing cap 25. The atrial flange of the prosthesis 29 is then anchored to the pulling means 26 by means of the anchoring hooks 28' as part of the rigid element 28. Acting on the holder 27, the prosthesis 29 is pulled into the mounted conical crimping device 21 until reaching the stop of the delivery tube securing cap 25 inside the delivery tube 24.

The prosthesis 29 is shown inside the delivery tube 24 in a crimped position in fig. 24. The atrial portion of the prosthesis (atrial valve) and the ventricular engagement arms 34 and 35 are exposed.

The loading procedure of the crimped prosthesis, for example, into the retrograde hydraulic delivery system 16 is depicted in fig. 25 (transapical procedure). The prosthesis, retracted inside the delivery tube 24 (on the atrial side for a retrograde implantation procedure), is inserted through the inner shaft 10 until the engagement arms 34 and 35 approach and engage the stop 8. The retaining clip 32 is then mounted over the engagement arms 34,35 to hold them straight and to retain the structures 11 and 12, respectively, on the stop 8. A threaded locking cap 33 is then screwed onto 10' to occlude the atrial valve. The retaining clamp 32 is then removed while the valve cover/ shaft 5,6 is advanced until loading of the prosthesis is complete. When loading is almost complete, the threaded locking cap 33 is unscrewed from the inner shaft 10 and removed. Screwing the tip 1 onto the crank 10' completes the prosthesis loading process. The system debubbling procedure is performed after the prosthetic valve is loaded into the delivery system and prior to implantation.

It should be mentioned that the conical element 21 and the transfer tube securing cap 25 are used during crimping, but are no longer used during loading, as shown in fig. 23 and 25.

The invention is of course not limited to the illustrated examples, but encompasses any alternative object defined by the claims.