WO2017202766A2

WO2017202766A2 - Flexible implants and method of use

Info

Publication number: WO2017202766A2
Application number: PCT/EP2017/062259
Authority: WO
Inventors: Nicolai HIORTH
Original assignee: Cardiomech As
Priority date: 2016-05-24
Filing date: 2017-05-22
Publication date: 2017-11-30
Also published as: WO2017202766A3

Abstract

The invention provides a flexible implant 6 that can be implanted endovascular with a system of catheters. The ring can shrink and/or stabilize the heart valve annulus/leaflets/atrium wall to act as a landing zone for a prosthetic valves or alone as a repair. The device comprising of: a everting stent based ring with a plurality of hooks, the hooks are mainly concealed when the ring is deployed, the ring can be everted in both directions, the eversion firmly engages the hooks with the surrounding tissue, after engagement the ring can be shrunk in size, or stabilized by introducing a suited locking mechanism on one or more adjustment wire(s) (7) that goes around the circumference of the flexible implant (6).

Description

FLEXIBLE IMPLANTS AND METHOD OF USE

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an implant, a catheter device and a method for implanting of such an implant. The implant may be used in heart valve repair, for example by stabilizing and/or shrinking the annulus of the mitral or tricuspid valve and as a platform for prosthetic valve placement.

BACKGROUND ART

The mitral valve, also known as the left atrioventricular valve, is a dual-leaflet valve in the heart that lies between the left atrium and the left ventricle. The mitral valve and the tricuspid valve are known collectively as the atrioventricular valves because they lie between the atria and the ventricles of the heart. They control the flow of blood by assuring unidirectional blood flow between the two heart chambers. The valve annulus is the area in the base/circumference of the heart valve. It is a structural component that supports the function of the valve leaflets. Thus, the mitral valve leaflets is anchored to the mitral annulus and attached to the inner wall of the left ventricle.

Mitral valve disease presents an important challenge to cardiac surgeons and cardiologists. Mitral regurgitation has become the leading pathophysiological condition of the mitral valve in the developed world. An important cause of regurgitation is prolapse of one of the mitral leaflets. A second important pathological condition is annular dilatation, which will decrease the coaptation (meeting and overlap) of the two mitral leaflets, resulting in valve leak. Such leak will decrease forward flow through the aorta and force the heart to increase the volume of pumping since part of the flow goes back to the left atrium. This volume load can result in a condition where increasing size of the mitral annulus stretches the mitral leaflets and thereby further decrease the coaptation of the anterior and posterior mitral valve leaflets. This results in a vicious circle where increasing leak causes increased dilatation, again increasing leak and further dilatation of the ventricle. The annular dilatation is frequently coexisting with other mitral pathology such as ruptured chords. In surgical mitral valve repair the procedure is usually combined with so-called annuloplasty to decrease the annulus size, thereby increasing leaflet coaptation.

Surgical repair of the mitral valve has become relatively standardized, using resection of the prolapsed leaflet or implantation of new, artificial chords to control leaflet motion. In addition a mitral ring is frequently placed to shrink the size of the mitral valve annulus. Surgical repair or replacement of the mitral valve is highly effective in reducing or minimizing mitral valve regurgitation. Such procedures are presently performed mainly with open heart surgery techniques. This requires use of cardiopulmonary bypass and arresting of the heart. This surgical approach, although working well, constitute a highly invasive procedure which can cause serious complications, long hospital stays and substantial expense. Consequently it would be preferred if the repair or valve replacement could be performed with a less invasive approach.

There is still no completely satisfactory method of mitral valve repair or

replacement using catheter-based techniques. Also there are several severe complications related to mitral valve replacement done with minimally invasive catheterization procedures. The most severe complications are dislodgement of the valve prosthesis and left ventricle outflow tract obstruction (LVOTO). Valve dislodgement can be caused by the lack of circumferential support due to the elasticity of the annulus and/or poor anchoring of the prosthetic valve. Mitral valve catheter based implantation is however successfully been performed in patients with a previously surgically placed annuloplasty ring. Such ring will give a stable landing zone for a prosthesis placed with catheters. LVOTO occurs when the native leaflets or the struts from a high profile prosthesis blocks the aortic outflow tract thereby causing obstruction. Complications involving LVOTO and valve

dislodgment have high mortality rates. Another common complication that is less severe on a short-term basis is paravalvular leak, leak around a prosthetic valve, this condition can result in further annular dilatation, hemolysis and endocarditis (infection of the native valve and surrounding structures).

The present referral pattern for mitral valve treatment (repair and/or replacement) includes an increasing number of patients with complex comorbid profiles. In this particular group of patients, reduction of the "interventional" trauma to correct the valve malfunction to minimize iatrogenic complications, perioperative morbidity and mortality is of great importance. In this context, future interventions addressing the mitral valve should be focused on a completely percutaneous and catheter based approach.

US 8715342 B2 describes one example of a system for annuloplasty by shrinking the valve annulus. In the described method an annuloplasty ring with intra-ring anchoring is placed along approximately 2/3 of the valve annulus. It consists of a sleeve, which is secured by several screw anchors that are placed one by one. A reel is used to shrink the sleeve by shortening a wire that lies inside the sleeve. Due to several anchoring steps the procedure is complicated and time consuming. As the ring only stretches about 2/3 of the circumference, it is not well suited as landing zone for prosthetic valves. Further, the system described in US 8715342 B2 does not prevent LVOTO. The reel limits the annular contraction due to its capacity, which might result in a non-reversible incomplete repair.

US 20130304197 Al describes a landing zone structure that can be placed inside a heart valve. In the described method a supportive structure can be placed within the valve apparatus to act as a stabilizer and/or adapter for an inserted valve. However, this arrangement does not prevent outflow tract obstruction either. The proposed anchoring solution of the structure does not sufficiently prevent further dilatation of the annulus, which may result in dislodgement of the entire structure or severe paravalvular leak.

US 5755772 A describes a system for anchoring of stent grafts, where parts of the graft body is everted to enlarge the cross section, and hence anchor the graft inside the vessels due to radial pressure. It is mentioned that the eversion can expose hooks, however US 5755772 A does not describe a system, which is applicable in valve repair or replacement.

Further, there is no mentioning of the eversion used as an active measure for anchoring and/or improving anchoring strength.

Thus there is a need for an implant, which avoids or alleviates at least some of the disadvantages of the prior art described above. The implant may preferably enable both annular shrinkage and stabilization of the mitral valve, as well as a stable landing platform for minimally invasive placed prosthetic valves SUMMARY OF INVENTION

The invention provides a flexible implant comprising a ring-shaped element provided with a throughgoing opening, the throughgoing opening having a center axis extending there through. The element has a first and a second face and a plurality of spaced apart hooks. Further the element is eversible. In one embodiment of the invention, the element of the flexible implant is rearrangeable between a first position where the element is cylinder-shaped, and non-radially extending, with the faces parallel to the center axis and the first face is turned inwards and the second face is turned outwards and a second position where the element is cylinder-shaped, and non-radially extending, with the faces parallel to the center axis where the first face is turned outwards and the second face is turned inwards, with an intermediate configuration wherein the element is non- axially extending, disc-shaped with the faces perpendicular to the center axis

In another embodiment of the flexible implant of the invention, the hooks are provided at an edge of the element. The hooks may also extend from the first or the second face of the element. Further the hooks may be bent in at least one of a same direction and in an opposite direction. Optionally the hooks may have barbs, and they may be placed all the way around a circumference of the element or only in certain regions (as illustrated in figure 2). Preferably, the hooks are placed at the edge of the element. The hooks may also have different angles, lengths and widths, to ensure crimpability.

According to yet another embodiment, the element is further provided with a plurality of spaced-apart adjustment holes. The adjustment holes may be placed anywhere at the element. In one preferred embodiment the holes are placed closer to or at the edge of the element. The element of the implant according to the invention may be a mesh, or a lattice, comprising a plurality of separate framework elements, wherein two adjacent elements is connected to each other through at least one connection point.

In one particular embodiment of the invention, the separate framework element comprises three squares connected together to a triangular form. Further, the implant of the invention may be provided with at least one adjustment wire (7) arranged in a circumference of the ring-shaped element. In one particular embodiment, the adjustment wire is arranged through the adjustment holes. This arrangement will provide a means for everting the implant.

As described herein the implant of the invention may be an adjustable annuloplasty ring and/or a landing zone for a prosthetic heart valve.

In one embodiment, the implant may further comprise prosthetic valves (18) and prosthetic valves leaflets 20 and/or flanges (19) and/or apex anchoring (22).

Thus the invention may be a system comprising an implant as described and prosthetic valve, leaflets, flanges and/or apex anchoring. In another aspect of the invention, the invention provides a catheter device for implanting of a flexible implant in a human body. The catheter device comprises an outer sheath (1), a deflectable sheath (4) being arranged inside the outer sheath (1) and an inner sheath (5) being arranged inside the deflectable sheath (4), the outer, the deflectable and the inner sheath and a support for the implant (1 , 4, 5, 9) being movable relative to each other, the support (9) for the flexible implant further being connected to an end of a dilator (2) including a guide wire lumen (3), the device further comprising release and manipulating devices for the flexible implant (6).

In one embodiment, the release and manipulating devices of the catheter device for the implant comprises at least one adjustment wire (7) and/or at least one adjustment tube (8)

A catheter device of the invention may further comprise a locking mechanism and a cutting mechanism for the adjustment wire(s) (7).

The flexible implant according to the invention may be for use as an annuloplasty ring and/or a stent.

The flexible implant or the catheter device according to the invention may be for use in medicine, such as heart repair, treatment of heart valve defects (such as valve regurgitation, preventing dislodgment of valve prosthesis, preventing left ventricle outflow tract obstruction), coronary disease, bariatric surgery or reflux disorder.

The invention also provides a method for inserting a flexible implant into a human body. The method according to this embodiment comprises the step of:

-introducing a catheter device into a lumen in the human body;

-retracting an outer sheath of the catheter device to expose an implant supported by a support in the catheter device;

-using at least one adjustment tube and/or at least one adjustment wire to expand and release the implant from the support;

-optionally using at least one guide tube and/or at least one guide wire to

manipulate the implant into a correct position at a desired location;

-using the at least one adjustment tube and/or at least one wire to bring the implant from a position where the faces of the implant extends in an axial direction to a position where the faces of the implant extends in a radial direction;

-guiding the implant into contact with the desired location, thus engaging a plurality of spaced apart hooks of the implant into tissue at the desired location; and

-disengaging the catheter device from the implant.

In one embodiment, after guiding the implant into contact with the desired location, the method further comprises the step of: -advancing the catheter device and implant further through the lumen, everting the implant and grasping additional tissue; and.

-retracting the catheter device to return the implant to a position where the faces of the implant extends in a radial direction ; and.

-disengaging the catheter device from the implant; and.

-Introducing one or more adjustment devices to shrink and/or stabilize the implant.

In one embodiment, the method is for introducing the implant to the heart with an endovascular, a trans apical or trans atrial approach or with open heart surgery

In another embodiment, the method further comprises the step of using a looped suture or wire around at least one part of the flexible implant to manipulating the shape and/or position of the implant.

It is also provided a method for treatment of heart disease/valve defects, the method comprising the step of:

-introducing a catheter device into the heart, such as through the atrial septum (transeptal) and into the left ventricle of the heart,

-retracting an outer sheath of the catheter device to expose a crimped implant supported by a support in the catheter device,

-using at least one adjustment tube and/or at least one adjustment wire to expand and release the implant from the support; -optionally using at least one guide tube and/or at least one guide wire to

manipulate the implant into a correct position in the heart, such as onto the mitral annulus and leaflets;

-guiding the implant into contact with the desired location, thus engaging a plurality of spaced apart hooks of the implant into tissue, such as the annulus or the atrial wall; and

-disengaging the catheter device from the implant. In one particular embodiment, this method may also further comprise the step of:

-advancing the catheter device and implant further through the valve, everting the implant and grasping leaflet tissue; and.

-disengaging the catheter device from the implant; and.

A "center axis" is hereinafter defined as the perpendicular axis to the horizontal plane in which the ring-shaped element extends radially.

The term "ring-shaped" as described herein is meant to include an endless or closed structure. It is not limited to the shape of a circle; it can be of a different shape, a symmetric or asymmetric shape, a D shape or other shapes, in particular other shapes fitted the anatomy of the heart and/or native heart valves. It may also have a three dimensional shape that fits the heart anatomy and the native valve anatomy. The shape of the implant may be subject-specific. As will be understood by the skilled person, the flexible implant may be a stent, an annuloplasty ring for use in heart repair, or a landing zone for prosthetic heart valves. In one embodiment the implant is both an annuloplasty ring and a landing zone for prosthetic valves, to be implanted at a later time.

The term "flexible" as described herein is meant to describe an item which is adaptable and/or adjustable. The element of the implant is able to resume its shape after being stretched or compressed. As described herein, the flexibility makes the ring element deployable from the crimped position during insertion, as well as adjustable in order to shrink and/or stabilize the tissue into which the flexible implant has been put. In one embodiment, the flexibility is obtained as the ring- shaped element have a geometric mesh as illustrated in Figure 2, with several framework elements connected to each other at least at one connection point.

Further, the flexibility enables the element to be rearrange between the first position where the element is cylinder-shaped, and non-radially extending, with the faces parallel to the center axis and the first face is turned inwards and the second face is turned outwards and the second position where the element is cylinder- shaped, and non-radially extending, with the faces parallel to the center axis where the first face is turned outwards and the second face is turned inwards, with an intermediate configuration wherein the element is non-axially extending, discshaped with the faces perpendicular to the center axis.

As will be understood by the skilled person, the flexible implant may be everted inside out, but the element may also be arranged in all different intermediate positions in-between, such as in the disc-shaped position and the like.

A "face" is herein defined as the side or surface of the implant. The implant has two sides or surfaces, facing either inwards or outwards, upwards or downwards, dependent on whether the implant extends in the axial or radial direction. The face as defined herein may be of different height. In one embodiment of the invention, the height may be adapted to the use within the heart and may then vary between approximately 2 and 40 mm in the deployed configuration (figure 2a, b, c, d).

The term "edge" of the element, as used herein is meant to describe the end of the element, the rim wherein the two faces meet. There are two edges. When the element extends in an axial direction, parallel to the center axis, the edges or ends may be referred to as an upper and a lower edge (end). When the element extends in a radial direction, perpendicular to the center axis, the edges may be referred to as the inner and outer edge (end). Dependent on the geometry of the ring-shaped element, the edges may be provided with a plurality of pointers (or tips).

The term "hook(s)" as used herein, is meant to include at least one hook, crook, peg, holder, trap, pin and the like, which fulfills the function of engaging and fasten the flexible implant into the tissue which it has been implanted. According to different embodiments of the invention, the proximal and distal hook(s) (1 1 , 12), optionally with barbs, can be placed all the way around or only in certain regions (as illustrated in Figure 2). The hooks may be bent in the same or in opposite directions, facing inwards or outwards. In different embodiments, the hooks are produced with different angles, lengths and widths, i.e. to ensure crimpability.

The term "eversible" as used herein refers to the ability to rearrange the element such as the element is turned inside out. As described herein the eversion include rearrangement from a position where the faces of the element is parallel to the center axis, thus extending in an axial direction with hooks facing in one direction to another position where the faces of the element is parallel to the center axis, thus extending in an axial direction with the hooks facing in the other direction.

The term "adjustment holes" as used herein refers to holes or openings around the circumference of the implant. The holes allows for adjustment of the ring-shaped elements, for example by making use of an "adjustment wire". The term

"adjustment wire" as used herein refers to a wire or line around the entire or parts of the circumference of the implant. In different embodiments the adjustment wire may be threaded in the holes and used to manipulate the implant in different shapes or positions and/or to stabilize the implant. The adjustment holes may also be used for other purposes, with or without the wire, such as for eversion of the implant by other means. The adjustment wire may also be routed in the ring circumference by other means. The term "framework elements" as used herein refers to a plurality of parts which put together constitute the mesh of the flexible element. The framework elements may have different forms in order to provide different degree of flexibility ( or elasticity) and stability. In one embodiment the framework element comprises a plurality of squares, connected to each other through at least one connection point. The term "cylinder-shaped" as described herein is not meant to be limited to a structure with a circular cross-section or a structure with equal distance between the two ends or equal geometry at each end. The cross section of the cylinder as defined herein can i.e. be of a different shape, for example a symmetric or an asymmetric shape, a D shape.. Furthermore the distances between the ends of the element can vary around the rim or circumference.

The term "disc-shaped" as described herein is not meant to be limited to a structure with circular circumferences. The circumference can be of a different shape, a symmetric or asymmetric shape, a D shape or other shapes, in particular other shapes fitted the anatomy of the heart and/or native heart valves. The inner and outer circumference of the disc may also be arranged in different planes relative to each other.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain preferred embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings in which:

Figure la illustrates the treatment catheter ready for insertion over a guide wire.

Figure lb illustrates the treatment catheter and how the flexible implant can be crimped onto the treatment catheter.

Figure lc illustrates how the flexible implant could be deployed. Figure 2a, b, c, d illustrate one potential way to evert the flexible implant, the treatment catheter is not shown in these illustration.

Figure 3a, b, c, d illustrates, with line drawings, the principle of grasping tissue by eversion in the mitral valve.

Figure 4 shows an example of a prosthetic valve with flanges and apex anchoring placed inside the invention described in figure 1 -3.

Figure 5 illustrates one possible way to place a flexible implant with an endovascular approach.

Figure 6 illustrates how a prosthetic valve may cause left ventricle out flow tract obstruction (LVOTO).

DETAILED DESCRIPTION OF THE INVENTION

The invention provides a flexible implant, which may be use as an annuloplasty ring for repair of a heart valve by either stabilization and/or shrinkage of the valve annulus/leaflet base. In contradiction to the procedure described in US 8715342 B2 the anchoring of the ring is done in one single controlled operation, which makes the procedure less complicated and less time consuming. The contraction of the annuloplasty ring in the described invention is done with a separate locking mechanism, with unlimited wire adjustment capability compared to a spool as described in US 8715342 B2 that is limited due to its capacity. The new flexible implant goes all the way around the annulus, hence there is minor chance for further annular dilatation.

The flexible implant according to the invention may also function as a stable landing platform for prosthetic valves. In contradiction to US 20130304197 Al the invention use eversion in combination with a plurality of hooks for better anchoring, that prevents further dilatation of the annulus after a valve is placed, which also reduces the chance of valve dislodgement. Another important feature is that the invention grasps parts of the leaflets to prevent LVOTO. An additional advantage compared with prior art is that the invention uses the native leaflets as seal against paravalvular leak which is a common, but less severe complication related to insertion of prosthetic valves. The flexible implant also has a low profile, which allows placement of a low profile valve within, which again reduces the probability for LVOTO.

In comparison to US 5755772 A the implant of the invention uses eversion to expose hooks/barbs to provide secure anchoring, grasping of the native leaflets to prevent paravalvular leak, further annular dilatation, valve dislodgment and left ventricle outflow tract obstruction.

The implant described above may be introduced by use of a catheter device, see fig. 1. Thus it is provided a new and improved catheter device to introduce the flexible implant 6 as described herein into tissue. The new catheter device is for implanting the flexible implant 6 in a human body. This new instrument provides a tool for non-surgical insertion of a flexible implant 6, it represents a new and improved system to address mitral regurgitation and may also function as a landing zone for valve prosthetic 18. The flexible implant 6 may be inserted with the catheter device by an endovascular, trans apical or trans atrial approach. The catheter device may be different to accommodate the different approaches. In one embodiment, the flexible implant 6 according to the invention is an annuloplasty ring. In this embodiment, the flexible implant 6 may be firmly attached to the valve annulus and base of the leaflets in one operation, further the flexible implant 6 may be used to shrink and/or stabilize the annulus. An important feature of the present invention in this embodiment is the possibility to grasp and hold the anterior leaflet 15, which often cause outflow tract obstruction when valves are implanted with catheters. Left ventricle outflow tract obstruction occurs when the anterior leaflet 15 block the aortic valve 13. This is a severe complication that may lead to death. The described invention will prevent LVOTO as the native valve is grasped and held by the hooks of the flexible implant 6. A further advantage of the present invention is the possibility to prevent embolism of implanted valves due to strong active anchoring. The invention can also shrink the annulus, which in many cases can be enough to eliminate valve regurgitation. Thus the new invention enables an easy and reliable operation to fasten the flexible implant 6, it prevents outflow track obstruction, embolism of valve prosthetic and the option to only stabilize or shrink the annulus thus providing significant advantages compared to earlier systems. In one particular embodiment, the catheter device is used to introduce the flexible implant to the heart by an endovascular approach, a trans apical or trans atrial approach. However, the catheter device and the flexible implant 6 could also be used in different procedures, including more invasive procedures such as open heart surgery, many of the advantages will remain.

The invention is illustrated by the figures.

Figure la illustrates one aspect of the invention, the catheter device with an outer sheath 1 that covers the internal components for safe introduction into body lumens of a subject, such as blood vessels and heart. The outer sheath 1 may also act as a guide under the adjustment, locking and cutting phase as the dilator 2 with the internal components can be retracted, leaving the outer sheath as a guide. The dilator 2 with a guide wire lumen 3 may facilitate the introduction into blood vessels and/or transeptal crossing as the catheter device can slide over a guide wire. Such a guide wire will also be helpful for positioning and deployment as it gives a stiff axis the catheters can slide on.

As illustrated in Figure lb, the catheter device may retract the outer sheath 1 to expose the crimped flexible implant 6. A deflectable sheath 4 is located inside the outer sheath 1 and the inner sheath 5 is located inside the deflectable sheath 4. The sheaths can be rotated, extended and retracted relative to each other, which may allow positioning and actuation of the flexible implant 6.

Figure lc illustrates one arrangement of the catheter device with the flexible implant 6 in a deployed configuration. The flexible implant 6 can be gradually released from the crimp support 9 with wires (not shown), adjustment tube(s) 8, adjustment wire(s) 7 and other suited release mechanisms, thus retracting the flexible implant 6 is possible. The adjustment wire(s) 7 can go around parts of or the entire circumference of the flexible implant 6. The adjustment wire(s) 7 is (are) anchored on itself or in the flexible implant 6. The adjustment wire(s) 7 goes through the adjustment tube(s) 8. As illustrated in Figure lc, the configuration may have three adjustment tube(s). However, the flexible implant may comprise of several more (or less) adjustment tube(s) 8, which optionally may be placed in different heights. The arrangement with adjustment tube(s) 8 without adjustment wire(s) 7, could optionally also comprise a looped suture or wire that goes around a part of the flexible implant 6, the adjustment wire 7 or other structures, thus allowing disengagement from the flexible implant 6. In this embodiment, the adjustment tube(s) 8, the deflectable sheath 4, the adjustment wire(s) 7, the inner sheath 5 and the entire catheter device can be manipulated to change the shape and position of the ring. The flexible implant 6 can also be attached to the catheter device with other means, such as small grippers, magnetized couplings, specialized wires or laser cut tubes to aid positioning and release of the flexible implant 6.

In another aspect of the invention, it is provided a flexible implant 6 as illustrated in Figure 2, the center axis 23 of the flexible implant 6 is illustrated in each figure.

Figure 2a illustrates the flexible implant 6 in a deployed configuration as in figure lc but without the deployment catheter. The flexible implant 6 is illustrated round, but as described herein, it may have a different shape, a D shape or other shapes fitted the anatomy of the native valve. The flexible implant 6 may comprise of a eversible stent mesh with a plurality of proximal and distal hook(s) 1 1 , 12 around the circumference of each edge. The illustrated flexible implant 6 has adjustment hole(s) 10, functioning as guides for the adjustment wire(s) 7 (not shown in this figure), the adjustment wire(s) 7 may also be routed in the mesh, or through other structures on the flexible implant 6. This figure shows one possible heat set configuration if the flexible implant 6 is self-expanding, meaning the shape it has when no constraining force is applied. The proximal and distal hook(s) 1 1 , 12 are partly concealed inside the flexible implant 6, to prevent entanglement during deployment. The proximal and distal hook(s) 1 1 , 12 may optionally have barbs, they can be placed all the way around or only in certain regions (as illustrated) and they can also be produced with different angles, lengths and widths, to ensure

crimpability.

Figure 2b illustrates the flexible implant 6 in a disc-shape without the catheter device; the proximal and distal hook(s) 1 1 , 12 are now exposed and ready to engage with tissue. The flexible implant 6 can obtain this shape by shortening the adjustment wire(s) 7 (not shown in this figure) or this shape could be the heat set configuration if the flexible implant 6 is self-expanding.

Figure 2c illustrates the flexible implant 6 fully everted, without the catheter device. The distal hook(s) 12 are now engaged with tissue, such as the annulus, base of the leaflets or the atrial wall in the heart, and the proximal hook(s) 1 1 are now exposed. In one embodiment, the proximal hooks 1 1 are arranged with barbs, in order to better grasp tissue such as the leaflets. In this embodiment, the grasping occur when counter pressure is applied by blood pressure, the valve apparatus (leaflets, chordae tendons etc) and/or a separate catheter placed through the aorta.

Figure 2d illustrates the flexible implant 6 everted back into a flat configuration without the catheter device. In this position, the distal hook(s) 12 may be firmly attached to tissue, such as the annulus, and parts of the leaflets may now be attached to the proximal hook(s) 1 1. The flexible implant 6 can be everted back to the configuration shown in 2c if needed, for further grasping of tissue. Note that the eversion from figure 2c to 2d will decrease the distance between the proximal hooks 1 1 , and hence act as a grasping mechanism. The ring could be configured with hooks that allow for retraction at this point. When the placement is confirmed, the adjustment wire(s) 7 (not shown in this figure) may be left temporarily locked and the catheter device may be disengaged and retracted. Optionally a suited locking and adjustment mechanism may be placed on the adjustment wire(s) 7 at this point to shrink and/or stabilized the flexible implant 6. In such embodiments when the flexible implant 6 is used as an annuloplasty ring in the heart, the result of this arrangement is a rigid structure around the annulus and parts of the leaflets, that optionally also allows for a new valve to be placed inside or a repair of the valve by shrinking/stabilizing the annulus itself.

Figure 3a illustrates the principle of the embodiment where the flexible implant 6 functions as an annuloplasty ring within the left atrium above the mitral valve. The aortic valve 13, the aorta 14, the left atrium 17 and the anterior and posterior leaflets 15, 16 are illustrated in line drawings. The flexible implant 6 is placed against the atrium walls, touching the annular plane with the distal edge of the flexible implant 6. The proximal and distal hook(s) 1 1 , 12 are concealed from the surrounding tissue.

Figure 3b illustrates the principle of the flexible implant 6 in a flat configuration in the left atrium above the mitral valve. The aortic valve 13, the aorta 14, the left atrium 17 and the anterior and posterior leaflets 15, 16 are illustrated in line drawings. The ring is advanced in the flat configuration; this will result in engagement of the distal hooks 12 into the annulus, atrium walls or base of the leaflets. Further advancement of the ring and release of the adjustment wire(s) 7 and adjustment tube(s) 8 (not shown in this figure) will evert the flexible implant 6. Figure 3c illustrates the principle of the flexible implant 6 in a fully everted configuration inside the mitral valve. The aortic valve 13, the aorta 14, the left atrium 17 and the anterior and posterior leaflets 15, 16 are illustrated in line drawings. The distal hook(s) 12 are now fully engaged with the annulus, the proximal hook(s) 1 1 will now pierce the anterior and posterior leaflets 15, 16. The grasping of the anterior leaflet 15 is an important feature, as this prevents LVOTO, a severe complication that often occur when prosthetic valves are placed.

Optionally, a deflectable or U shaped catheter or wire could also be introduced through the aorta 14 and the aortic valve 13, to function as a counter force or to push/clamp the anterior and posterior leaflet 15, 16 onto the proximal hook(s) 1 1. Note that this may be done with the flexible implant 6 in a flat configuration (figure 3d) as well. In another embodiment, it is also possible to use magnetic

wires/catheter tips, where one magnet is placed above the proximal hook(s) 1 1 and one below with the leaflet in between, this would allow clamping of the leaflets onto the proximal hook(s) 1 1 without a sophisticated navigation system. The adjustment/locking/cutting catheter(s) may according to this embodiment be configured with magnet tips.

Figure 3d illustrate the principle of the flexible implant 6 in a flat configuration fully engaged with the mitral valve annulus and the anterior and posterior leaflets 15, 16. The aortic valve 13, the aorta 14, the left atrium 17 and the anterior and posterior leaflets 15, 16 are illustrated in line drawings. The center part of the valve is still functional, which means that only an insertion of the flexible implant 6 may be enough to stabilize or shrink the annulus thus act as a repair. Furthermore, as the anterior leaflet 15 is locked by the proximal hooks 1 1 LVOTO is prevented if a new valve is placed within the flexible implant 6. The flexible implant 6 may also provide a rigid structure where any type of catheter based valves can be placed. Note that the flexible implant 6 may be fixed with the proximal hooks 1 1 in another plane than the distal hooks 12, by for example manipulating and locking of the adjustment wire(s) 7.

Figure 4 illustrates a prosthetic valve 18 with prosthetic valve leaflets 20, flanges 19 and apex anchoring 22 placed within the flexible implant 6. The apex anchor 22 is connected to the prosthetic valve 18 with three stabilizing chordae(s) 21 that can be individually adjusted in length. The apex anchor 22 may be similar to the one described in detail in the patent application WO2016042022. The apex anchor 22 and the prosthetic valve 18 can be placed through the outer sheath 1 (not shown in this figure) after the flexible implant 6 is shrunk and/or stabilized. First step is to place the apex anchor 22, secondly the prosthetic valve 18 with attached stabilizing chordae(s) 21 , the stabilizing chordae(s) 21 are then adjusted, locked and cut. This operation may be done with a single catheter. The flanges 19 may lock the leaflets onto the proximal hooks 1 1 (not shown in this figure) making a "sandwich" of leaflets flexible implant 6 and flanges 19. That will minimize paravalvular leakage, which is a common complication with minimally invasive valve replacement procedures. Any type of catheter based valve can be placed within the flexible implant 6, for example a prosthetic valve 18 with flanges 19 but without apex anchor 22, valves with radial pressure anchoring or other types of valves. Valves that are originally meant for aortic replacement could also be used with or without modifications. Figure 5 shows an overview of an endovascular introduction of the catheter device to the left atrium, the illustration is a combination of figure l c and 3 a. The flexible implant 6 is in the deployed configuration (figure lc) ready to be turned into a discshape and advanced onto the mitral annulus. Figure 6 illustrates how a prosthetic mitral valve may cause left ventricular out flow trackt obstruction (LVOTO). Note that high profile prosthetic mitral valves may also block the aorta with parts of their structure.

The invention as described herein is a flexible implant 6 comprising an ring-shaped eversible element. The eversible element may be described as a mesh or a lattice, which comprises separate framework elements. The mesh, or lattice, may comprise a plurality of separate framework elements, wherein two adjacent elements is connected to each other through at least one connection point. In one embodiment, the framework elements of the mesh comprises three squares connected together to a triangular form, as illustrated in figure 2a The meshes to be used in the flexible implant 6 may have different geometry, the important feature is that the geometry allows for eversion in the deployed configuration (as shown in figure 2a, b, c, d). The framework elements of the implant body may be a stent based mesh. In one embodiment of the invention, the adjustment wire(s) 7 of the implant goes through the adjustment hole(s) 10, in another embodiment the flexible implant 6 is without any adjustment hole(s) 10. In this embodiment, the adjustment wire(s) 7 may be routed inside the flexible implant 6 framework, or in wire loops attached to the flexible implant 6. The adjustment wire(s) 7 may be anchored in the flexible implant 6 with for example hole(s), welds or knots, or it could be anchored in itself (similar to a lasso) by crimped tubes or with other suited techniques. The

adjustment wire(s) 7 could be any type of sutures or wires, such as Nitinol or stainless steel wire, uhmwpe (ultra high molecular weight polyethylene) suture or a combination of several materials.

The flexible implant 6 according to the invention may be used for several purposes, thus several version of the flexible implant 6 is provided. For example may one be optimized for annular shrinking, one for annular stabilization and one for valve placement, where geometries, hooks, eversion sequences and such are optimized for the given procedure. Different sizes within each category may also be needed, as the heart geometry varies from person to person. The flexible implant 6 may also be custom made for each patient with a heat set ring that is custom fitted to the patient anatomy. The distal and proximal edge of the flexible implant 6 could of course be heat set with different diameters, curvatures and angles to accommodate the different geometries. Thus the invention may provide subject-specific flexible implants 6, optimized for each subject.

The height of the flexible implant 6 could vary between approximately 2 and 40 mm in the deployed configuration (figure 2a,b,c,d), the mean outer diameter in deployed configuration (figure 2a,b,c,d) could be between approximately 25 and 70 mm when used within the heart. Different sizes may be needed if the flexible implant 6 is used in other types of interventions, such as implantation in the stomach or in blood vessels. There are several locking and adjustment mechanisms that can be used together with the flexible implant 6 as described in this application. One example is the tissue anchor described in WO2016042022 that could be used with minor modifications. As disclosed herein, the anchor may be introduced over the adjustment wire(s) 7 and onto the flexible implant 6, the hooks on the anchor body may engage with the mesh in the flexible implant 6 and/or the tissue beneath. Thus the anchor is secured to the flexible implant 6 and/or the tissue beneath, while the adjustment and locking may enable an adjustable and stable flexible implant 6. Another example is the medical clip described in US8523880 B2. Such a clip may be introduced over the adjustment wire(s) 7 and enabled adjustment and locking of the flexible implant 6. Anchoring barbs could optionally be included in this design, to anchor the mechanism onto the flexible implant 6 and/or surrounding tissue. In another embodiment the locking and adjustment mechanism could be implemented into the flexible implant 6, with a locking and/or adjustment mechanism similar to the ones described above or other suited mechanism.

The cutting of excess wire could be done in several ways known to the skilled person, such as disclosed in WO2016042022. In another embodiment an inflatable balloon may be used to actuate a modified scissors/guillotine, to enable cutting of the excess adjustment wire(s) 7.

The procedure can be split into three individual steps done by three types of catheters: 1. Placement of the flexible implant 6. 2. Adjustment and locking of the flexible implant 6. 3. Cutting of excess adjustment wire(s) 7. The cutting

mechanism may optionally be combined with the locking and adjustment mechanism to allow the procedure to be done with two catheters, or in a third embodiment, all three steps are combined in one catheter. The deployment phase of the procedure is based on well-known catheter techniques involving wires, sutures and tubes well known to the skilled person. To obtain a good result, in particular in endovascular procedures, visualization is crucial. In one embodiment, the dilator 2 and outer sheath 1 may therefore be made echogenic by grooves and/or a special coating. There may also be included x-ray markers to the flexible implant 6, dilator 2 and outer sheath 1 , to aid in positioning of the implant. A thin porous membrane may be included on the stent body of the flexible implant 6 as this may improve visibility on ultrasound.

The flexible implant 6 according to the invention may be produced with several methods known to the skilled person. Preferably, the flexible implant 6 is produced as a self-expanding implant, meaning that the flexible implant 6 can be shrunk into a small diameter, by applying a constraining force, preferably in a cold

environment. The production can be done by laser cutting a shape memory alloy tube such as nitinol (nickel titanium alloy). In another embodiment, the flexible implant 6 is cut from a sheet in a flat configuration, for example as described in US 6327772 B. In a preferred embodiment, the flexible implant 6 is cut with the proximal and distal hook(s) 1 1 , 12 as one part. The cut part could then be heat set into an expanded configuration similar to the ones illustrated in figure 2 a, b, c, d. The parts may optionally be electro-polished to prevent sharp edges and improve fatigue properties.

The following list describes one possible production method for the flexible implant 6:

• The flexible implant 6 is laser cut from a nitinol tube, with the hooks straight and the framework compressed.

• The flexible implant 6 is then expanded over mandrels and heat treated into the expanded configuration, with the ring elements between an axial and radial direction.

• The flexible implant 6 is then placed in different heat setting tools, which bends the hooks into their position.

• The implant 6 can now be electropolished to remove any sharp edges.

Protective layers of ptfe or similar can now be applied if needed.

• At least one adjustment wire 7 is now placed thorough the adjustment holes 10 or the ring framework. The wire(s) can be anchored in itself or in a part of the framework.

• The implant 6 is now loaded and crimped onto the catheter device. The

crimping should be done in a cold environment to ease the process.

• The outer sheath 1 is advanced to cover the crimped flexible implant 6. The device is now ready for use.

A self-expanding flexible implant 6 may also be produced with other production methods. The ring could be made with braiding and/or welding of metal wires or a combination of braided and/or welded wires and laser cut tube(s). By using shape memory alloys or other super elastic materials, such as nitinol the flexible implant 6 can be made self-expandable also with other production methods. Although the flexible implant 6 would preferably be a self-expanding implant, it could also be cut from materials without super elastic properties. In one embodiment the flexible implant 6 could be cut from a tube, for example stainless steel, the proximal and distal hook(s) 1 1 , 12 could then be bent inside the tube. This embodiment allows for the placement of the implant inside the left atrium 17 to be performed with an inflatable balloon. The eversion and grasping process would be similar as described above. Note that a self-expanding flexible implant 6 also could use an inflatable balloon, to help with positioning of the implant.

The flexible implant 6 does not need to be heat set symmetrical, it could for example be shaped as a D, or have a three dimensional shape that fits the native valve anatomy. Optionally, the height, width, angle and curvature of the flexible implant 6 is different from one section to another, in one such embodiment, the different framework elements may be able to grasp more of the anterior leaflet 15 and less of the posterior leaflet 16 as illustrated in figure 3c. The proximal and distal hook(s) 1 1 , 12, optionally with barbs, can vary in size, width and length. The hooks may be produced with different angles relative to the flexible implant 6 body, this will allow some hooks to be less concealed than others during deployment, and allow crimping (large reduction in outer diameter) onto the catheter device.

Segments of the flexible implant 6 could also be produced with hooks that are not concealed. Some hooks may also be produced as straight dull pin (similar to a popsicle stick), this detail may increase the radial holding force of the flexible implant 6 under the eversion process illustrated in figure 3b. The number of hooks can be modified, there could for example be 60 or more/less hooks on each end or edge of the flexible implant 6. If necessary, there could also be implemented a plurality of hooks with or without barbs in the other sections of the flexible implant 6 body. In one embodiment of the invention, the flexible implant is covered with a variety of different materials or coatings to aid healing, tissue ingrowth, prevent mechanical failure and lower paravalvular leakage. Different materials or coating may be: a pericardium membrane, a thin ePTFE or PTFE membrane/mesh/fabric, a dacron membrane/mesh/fabric, a uhmwpe wire/fabric/mesh woven around the flexible implant 6 framework. These fabrics could also extend outside the flexible implant 6, to act as seals against the surrounding tissue, and/or against a placed prosthetic valve. In one embodiment, prosthetic leaflets may be implemented on the outside of the flexible implant 6, the leaflets will not be pierced by the proximal or distal hook(s) 1 1 ,12 during deployment. When the eversion occur the leaflets will be exposed and covering the central part of the flexible implant 6, and hence act as a valve. This could be used as a temporary or a permanent valve. The temporary valve may decrease para valvular leakage if a new prosthetic valve 18 is placed within.

There are several more ways to perform the eversion than what is described in figure 2 and 3. One example of an eversion sequence is to evert the flexible implant 6 back into the deployed configuration (fig 2a) after the steps described above. This could be done with modified hooks (for example with the proximal hook(s) 1 1 bent in the opposite direction than the distal hook(s) 12), and with at least one

adjustment wire 7 routed inside the distal part of the flexible implant 6. The result would be a flexible implant 6 well anchored in the annulus and in the atrial wall, which could be useful for annular shrinkage. The proximal hook(s) 1 1 may optionally interfere with the native valve leaflets in this configuration. Another example of an eversion sequence is to place the flexible implant 6 inside a native valve as illustrated in figure 2c and everted into the atrium to make a different engagement to the leaflet, annulus and atrium walls. Alterations to the catheter device may be needed to achieve different eversion sequences.

From a functional point of view it should be noted that the flexible implant 6 has a low profile after placement, thus minimizing affection on surrounding heart structures. Another important feature is the active anchoring provided by the hooks, once the flexible implant 6 is placed and shrunk/stabilized it is not dependent on radial pressure, as the system will be firmly attached to the tissue. This allows for radial pressure valves to be placed within the flexible implant 6 without radial pressure exerted on the native annulus. As the native annulus may expand if placed under radial pressure, thus resulting in dislodgement in a given amount of time, the invention provides a technical advantage compared to the prior art. Another advantage is that placement of a new valve within the flexible implant 6 will be simplified, as the flexible implant 6 will act as a reference point to where the new valve should be placed.

A list of advantages compared to similar technology that is presently in use within the heart is described below:

^A The prosthetic mitral valve ring/ stent may be implanted totally

percutaneously, through the femoral vein.

A No access through the left ventricular apex is required.

^ The ring/stent will anchor to the entire native mitral annulus and native

mitral valve leaflets simultaneously in a controlled way.

No "screwing" or "suturing" of the device to the native annulus is required, so to minimized intracardiac instrumentation.

^ The ring/stent will be actively fixating itself to the native mitral valve

components (MV annulus, leaflets and annular wall) due to the hooks and the everting properties of the flexible implant 6

^ The radial force exerted on the native annulus may be minimal and, as

emphasized above, anchoring of the device will be active. ^ The minimized radial force exerted on the native mitral valve annulus will reduce the risk of interference with the cardiac anatomical "boundaries" in particular with the left ventricular outflow tract and aortic valve.

^ The risk of systolic movement of the native anterior MV leaflet, with

consequent obstruction of the left ventricular outflow (LVOTO), will be reduced, due to the attachment of the implant on the anterior leaflet itself, exerted by the released stent/ring engaging in the tissue.

^A Simultaneous grasping of part of the mitral leaflets and native mitral annulus will optimize anchoring and will seal the implant into the tissue, thus reducing the risk of subsequent para-prosthetic leak

^A In different embodiment, the ring/stent can work as an annuloplasty tool for percutaneous mitral valve repair and as a prosthetic ring to land or place a prosthetic valve. This may optionally be performed in a second phase of the procedure.

In one aspect of the invention it is provided a method for treating valve defects by making use of the catheter device for implanting the flexible implant 6 according to the invention. As such, the invention provides a system for use in treatment of heart disease, such as valve defects, mitral regurgitation and the like. The system, comprising the catheter device and the flexible implant 6 as described herein, may be used by an endovascular, trans apical, trans atrial approach or with open heart surgery. The catheter devices may be different for the different approaches. One example of the procedure of using the catheter device with an endovascular approach on the mitral valve can be summarized as follows:

1. A guide wire is placed in the femoral vein through the atrial septum

(transeptal) and into the left ventricle, using standardized techniques.

2. The catheter device is advanced over the guide wire to the left atrium with guidance such as x-ray and/or ultrasound.

3. The dilator 2 allows easy transeptal crossing, the deflectable sheath 4 and the guide wire allows the device to be positioned in the middle of the mitral valve.

4. The outer sheath 1 is retracted to expose the crimped flexible implant 6.

5. The flexible implant 6 is gradually released from the crimp support 9 with wires (not illustrated).

6. The flexible implant 6 is now supported by the atrial walls and/or the

adjustment tube(s) 8.

7. The flexible implant 6 can now be manipulated with the inner shaft 5, the deflectable shaft 4, the adjustment wire(s) 7, the crimp support and the adjustment tube(s) 8. 8. When correct position is achieved, the adjustment wire(s) 7 together with adjustment tube(s) 8 can turn the ring into a disc-shape.

9. The disc is advanced onto the mitral annulus and leaflets; this causes the distal hook(s) 12 to engage with the annulus or the atrial wall. The engagement causes the flexible implant 6 to fully evert and pierce the anterior and posterior leaflets 15,16 with the proximal hook(s) 1 1.

10. The flexible implant 6 is everted back into a flat configuration, with parts of the anterior and posterior leaflets 15, 16. The catheter device is disengaged from the flexible implant 6 and retracted leaving the adjustment wire(s) 7 temporarily locked and connected to the flexible implant 6. The outer sheath 1 is not retracted and can act as a guide for the adjustment phase or other procedures.

1 1. A suited adjustment and locking mechanism is advanced over the adjustment wire(s) 7 with a separate catheter. The adjustment and locking catheter adjusts the size and/or stabilizes the flexible implant 6 by locking the adjustment wire(s) 7, this catheter could also includes a suited cutting mechanism that can cut the excess wire(s).

12. The adjustment catheter is retracted and the annuloplasty procedure is

complete. Shrinking of the annulus can be enough to prevent mitral regurgitation by itself, if not, a new valve can be inserted into the reinforced annulus, the device thus preventing embolism of the valve and outflow tract obstruction.

13. It is possible to keep the length of the adjustment wire(s) 7 and make it

accessible from outside the body, this will allow further adjustment of the ring several months after the procedure.

The successful use of this technique being employed endovascular will drastically reduce the invasiveness, complications and cost of mitral valve repair and replacement.

As will be understood by the skilled person, the flexible implant according to the invention can be used in other parts of the human body. With adjustment to the size to fit different organs and function, the concept may be used to: stomach shrinking as part of a weight control procedure or repair of geometries within the stomach, landing zones for stentgrafts, repair of vessel walls, small intestine repair, colon repair etc. List of figure names:

1 outer sheath

2 dilator

3 guide wire lumen

4 deflectable sheath

5 inner sheath

6 flexible implant

7 adjustment wire

8 adjustment tube

9 crimp support

10 adjustment hole

1 1 proximal hooks

12 distal hooks

13 aortic valve

14 aorta

15 anterior leaflet

16 posterior leaflet

17 left atrium

18 valve prosthetic

19 flanges

20 prosthetic valve leaflets

21 stabilizing chordaes

22 apex anchoring

23 Center axis

Claims

1. A flexible implant (6) for a human body comprising a ring-shaped, eversible element provided with a throughgoing opening, having a center axis (23) extending there through, the element having a first and a second face and a plurality of spaced apart hooks (1 1 , 12), wherein the element is rearrangeable between a first position where the element is cylinder-shaped with the faces extending in an axial direction parallel to the center axis and the first face is turned inwards and the second face is turned outwards and a second position where the element is cylinder-shaped with the faces extending in an axial direction parallel to the center axis where the first face is turned outwards and the second face is turned inwards, with an intermediate configuration wherein the element is disc-shaped with the faces extending in a radial direction perpendicular to the center axis.

2. An implant according to any the proceeding claims, wherein the hooks (1 1 , 12) are provided at an edge of the element, or extending from the first or the second face of the element.

3. An implant according to any of the proceeding claims, wherein the

element further is provided with a plurality of spaced-apart adjustment holes (10).

4. An implant according to any proceeding claims, wherein the element is a mesh comprising a plurality of separate framework elements, two adjacent elements being connected to each other through at least one connection point.

5. An implant according to claim 3, wherein the separate framework

element comprises three squares connected together to a triangular form.

6. An implant according to any proceeding claims, wherein a plurality of hooks are bent in at least one of a same direction and in an opposite direction.

7. An implant according to any proceeding claims, wherein at least one adjustment wire (7) is arranged in a circumference of the ring-shaped element.

8. An implant according to any proceeding claims, wherein the implant is an adjustable annuloplasty ring and/or a landing zone for a prosthetic heart valve.

9. An implant according to any proceeding claims, wherein the implant further comprises prosthetic valves (18) and prosthetic valves leaflets 20 and/or flanges (19) and/or apex anchoring (22).

10. A catheter device for implanting of a flexible implant (6) in a human body, the device comprising an outer sheath (1), a deflectable sheath (4) being arranged inside the outer sheath (1) and an inner sheath (5) being arranged inside the deflectable sheath (4), the outer, the deflectable and the inner sheath and a support for the implant (1 , 4, 5, 9) being movable relative to each other, the support (9) for the flexible implant further being connected to an end of a dilator (2) including a guide wire lumen (3), the device further comprising release and manipulating devices for the flexible implant (6).

1 1. A catheter device according to claim 8, wherein the release and

manipulating devices for the implant comprises at least one adjustment wire (7) and/or at least one adjustment tube (8)

12. A catheter device according to any one of the proceeding claims 10-1 1 , wherein the catheter device further comprises a locking mechanism and a cutting mechanism for the adjustment wire(s) (7).

13. A flexible implant according to any one of the claims 1-8 for use as an annuloplasty ring and/or a stent.

14. A flexible implant according to any one of the claims 1-10 or the catheter device according to any of the claims 10-12 for use in medicine, such as heart repair, treatment of heart valve defects (such as valve regurgitation, preventing dislodgment of valve prosthesis, preventing left ventricle outflow tract obstruction), coronary disease, bariatric surgery or reflux disorder.

15. A method for inserting a flexible implant into a human body, the method comprising:

-introducing a catheter device according to one or more of claims 10-12 into a lumen in the human body;

-optionally using at least one guide tube and/or at least one guide wire to manipulate the implant into a correct position at a desired location;

-guiding the implant into contact with the desired location, thus engaging a plurality of spaced apart hooks of the implant into tissue at the desired location; and.

-disengaging the catheter device from the implant; and.

16. A method according to claim 14, wherein the method is for introducing the implant to the heart with an endovascular, a trans apical or trans atrial approach or with open heart surgery

17. A method according to any of claim, wherein the method further

comprises the step of using a looped suture or wire around at least one part of the flexible implant to manipulating the shape and /or position of the implant.