A device and method for improving the function of a heart valve

The present invention generally relates to devices for heart valve repair and annuloplasty. More specifically, the invention relates to the repair of heart valves having various malformations and functional disorders.

Background of the Invention [0002] Mitral and tricuspid valves often require replacement or repair. Mitral or tricuspid flaps or support tendons may degenerate or weaken, or the ring may widen, leading to valve leakage (regurgitation). Mitral and tricuspid lobes and tendons may undergo calcification and thickening making them narrowed (blocking further flow). Finally, the valve rests on the tendon's attachment inside the chamber. If the chamber changes shape, the valve support may stop functioning and the valve may leak.

[0003] Replacement of the mitral valve and tricuspid valve and repair are usually performed by the stitching method. When replacing the valve, the sutures are placed around the valve ring (the point where the valve flap is attached to the heart), after which the sutures are attached to the prosthetic valve. The valve is lowered to a certain position and, after the seams are installed, the valve is attached to this ring. The surgeon may remove all or part of the valve leaflets before inserting the prosthetic valve. When replacing the valve, the affected valve remains in place and the surgical procedures are carried out to restore its function. Often an annuloplastic ring is used to reduce the size of the ring. The ring serves to reduce the diameter of the annulus and usually allows the valve petals to resist each other. Sutures are used to attach the prosthetic ring to the annulus of the valve and to help fold the annulus of the valve. [0004] In general, annuloplasty rings and replacement valves must be sewn to the valve annulus, which is time-consuming and cumbersome. If the ring is in a wrong position, then the seams must be removed and the ring must be repositioned relative to the valve annulus during re-stitching. In other cases, less than optimal annuloplasty may be tolerated by the surgeon more than the prolongation of the surgical operation time to reseal the ring. [0005] During heart surgery, the emphasis is on limiting the amount of time needed to replace and repair the valves, because the heart rate is often stopped and there is no perfusion.

[0006] In US 6,419,696 an annuloplastic device is disclosed. The device includes a first and a second support ring configured to rest on opposite sides of the annulus of the valve to thereby entrap the valve tissue between itself. The device may be used in those situations in which annuloplasty rings have been conventionally used, but this device can be used in a much easier way by rotating the rings to a position on the opposite sides of the annulus.

[0007] US6702826 discloses an arrangement for cardiac annuloplasty. A bonding tape is disclosed that is held in place by the folding belts. The connecting tape can be flexible so that it can be deformed when fastened by folding belts. It has also been disclosed that the folding strips can shrink the tissue to re-shape the ring.

[0008] US2004 / 243230 discloses an annuloplastic annulus and a boundary conduit for retaining the wing members in the radial direction during the delivery and placement of the annulus. The ring is developed by a balloon. The boundary wire is released so that the wing members spring into their convex shape and are placed on the heart wall and the balloon is removed. The ring can be adjusted by tightening the boundary wire to push the wing members upward, and then inflate the balloon again. Raising the temperature of the ring support member causes the ring to shrink, which reduces the size of the ring.

Summary of the invention [0009] The object of the present invention is to provide a more reliable and easier to perform valve repair. It is a particular object of the present invention to facilitate the insertion of an annuloplast implant.

[0010] These and other objects of the invention are achieved by means of an apparatus and method according to the independent claims. Preferred embodiments of the invention result from the dependent claims.

[0011] Thus, according to a first aspect of the invention, there is provided a device for improving the function of the heart valve, consisting of a valve tissue comprising a ring and a plurality of petals to allow and prevent blood flow. The device comprises a support member at least partially formed of a shape memory material capable of adopting an activated shape and an inactivated shape, and a limiting member that is adapted to provide a limiting effect on the path of the support member. The support member is configured to rest on one side of the valve and is arranged to conform to the shape of at least part of the valve annulus after said shape memory material adopts said activated shape, while the limiting member exerts a limiting effect on the path of the support member. The limiting member is formed of biodegradable degradable material when the device is implanted in the patient, where the degradation of the limiting member removes the limiting action and allows the support member to receive the desired, changed path.

[0012] According to one example, a device is provided for improving the function of the heart valve consisting of a valve tissue comprising a ring and a plurality of petals to allow and prevent blood flow. The device includes a support member that is configured to rest on one side of the valve and is arranged to conform to the shape of at least a portion of the annulus. The support member has an inherent fit to change the shape so that an increase in the cross-section of at least a portion of the support member is associated with shortening the length of the support member, the support member being subject to widening the cross-section of the support member when the support member has adapted to the shape of at least a portion ring of the valve,

[0013] According to one example, a device is disclosed for improving the function of a heart valve consisting of a valve tissue comprising a ring and a plurality of petals to allow and prevent blood flow. The device comprises a support member at least partially formed of a shape memory material capable of receiving the first shape of an activated, secondly activated, and inactivated shape. The support member is configured to rest on one side of the valve and is arranged to conform to the shape of at least part of the valve annulus after said shape memory material assumes said first activated form. The supporting member is further configured to receive the desired, an altered track for rebuilding the valve ring after said shape memory material adopts said second activated form. The shape memory material is arranged such that heating the shape memory material to a first temperature will feed the shape memory material to receive said first activated shape and further heating the shape memory material to a second temperature will lead the shape memory material to receive said second activated shape.

[0014] According to a second embodiment of the invention, there is provided a device for improving the function of the heart valve, consisting of a valve tissue comprising a ring and a plurality of petals to allow and prevent blood flow. The device comprises a support member at least partially formed from a shape memory material adapted to receive an activated shape and an inactivated shape and a limiting member which is arranged to provide a limiting effect on the path of the support member. The support member is configured to rest on one side of the valve and is arranged to conform to the shape of at least part of the valve annulus after said shape memory material adopts said activated shape, while the limiting member exerts a limiting effect on the path of the support member. The limiting member is detachable from the support member to release the constraint and to allow the retaining member to receive the desired changed path.

[0015] In accordance with all embodiments of the invention, the support member may be arranged in a configuration for resting on one side of the valve adapted to the shape of at least part of the annulus of the valve. The support member may also adopt the desired, changed shape. In accordance with all aspects of the invention, the device provides the ability to control when the support member is to receive the desired, changed shape. This means that the support member can be attached to the valve before accepting the desired, altered shape. Thus, all embodiments of the present invention provide the ability to control when the support member assumes the desired, changed shape.

[0016] According to the first and second embodiments of the invention, the limiting member delays the support member in receiving the memorized, desired shape. The restriction member allows the support member to adapt to the shape of at least part of the annulus of the valve, but prevents the retaining member from receiving the desired path. This means that the support member can be permanently anchored to the valve tissue before the support member assumes the desired path. Thus, when the limiting action is removed to release the restriction on the support member, the support member will guide the valve tissue to the desired path. The shape change of the support member can be designed in such a way that the valve tissue is pulled towards the opening in the valve,

[0017] The support member may have an initial shape when placed in a heart valve that conforms to the shape of the widened annulus. Thus, there is no need to force the rebuilt shape on the heart valve when the support member is to be attached to the valve. This means that the support member can be more easily attached to the valve, especially when working on a beating heart. When the support member is permanently attached to the valve, it may be allowed to change shape so that the remodeling of the heart valve is performed.

Since the restriction element is biodegradable when removing the limiting effect according to the first embodiment of the present invention, the support member can be permanently anchored in the valve tissue by the endothelial cell hypertrophy, while the limiting member is staggered. Thus, when the limiting member has degraded to release the constraint on the support member, the support member brings the valve tissue with him to the desired path. In addition, the surgeon may leave both the support member and the restraining member in the patient after implantation and the degradation will be performed by the patient's immune system acting on the limiting member.

[0019] According to one example, the shape change of the support member can be actively controlled by applying a force to increase its cross-section. Thus, the support member can be attached to the valve before applying a force to increase the cross-section. The support member is suitable for adapting to the shape of at least part of the annulus of the valve, but it does not affect its cross-section to accommodate the desired shape. This means that the support member can be permanently anchored in the valve tissue before the support member has an influence on the desired shape. Thus, when an increase in the cross-section is obtained, the support member will bring the valve tissue with it to the desired shape. Because the supporting member is shortened,

[0020] The support member may have an initial shape when placed in a heart valve that conforms to the shape of the widened annulus. Thus, there is no need to force a shape remodeling on the heart valve when the support member is to be attached to the valve. This means that the support member can be more easily attached to the valve, especially when working on a beating heart. After the support member is permanently attached to the valve, a change in shape can be made possible that a remodeling of the heart valve is performed.

[0021] The cross-section of the support member may be increased in specific portions of the support member. The increase in the cross-section is directed to parts that are particularly suitable for the treatment of the heart valve. The decision about which parts are to be manipulated based on the shape of the heart valve and the desired remodeling of the heart valve. Thus, the device makes it possible to control the remodeling of the heart valve, which is formed by locally increasing the cross-section. However, the cross-section of the support member may alternatively be increased over the entire length of the support member, such that overall shortening of the support member is achieved by treating the heart valve symmetrically.

[0022] According to one embodiment, the shape change of the support member can be actively controlled by adjusting the temperature of the support member. Thus, the support member can be attached to the valve when the support member is held in a first shape activated by keeping the temperature of the support member above said first temperature but below said second temperature. This means that the support member can be permanently anchored in the valve tissue before the support member is heated to receive the desired shape. In this way, when the supporting member is heated to receive its second activated form, the support member will bring the valve tissue with it to the desired shape. Because the support member assumes its desired shape,

[0023] According to a second embodiment of the invention, the limiting member is detachable from the support member to remove the limiting effect. This means that the surgeon can actively disconnect and remove the restraining member after which the support member has been appropriately attached to the valve tissue.

[0024] The invention in accordance with any form contemplates various embodiments of the device, including embodiments for a catheter-based operation and embodiments for open heart surgery.

[0025] According to the first and second embodiments of the invention, the support member may be adapted to bring about the shape activated by adopting induced heating in selective parts of the support member. Thus, the support member can be inserted into the desired position in the inactivated shape, and the shape of the support member during insertion is controlled by both the limiting member and the support member not seeking to receive the desired path. By selectively heating the support member, the selective parts of the support member can be brought into an activated shape and the heating controls what shape the support member will adopt. Selective heating can be realized by means of a catheter, with a heating element, which can be brought into contact with selective parts of the support member. The heating of the support member will initiate the aspiration of the support member to receive an activated shape. To facilitate placement and attachment of the carrier to the heart valve, the support member can be permanently attached to the valve before the support member is heated. [0026] In accordance with all aspects of the invention, the support member may be adapted to receive a reduced radius of curvature in an altered shape. This means that the valve ring can be remodeled so that it is moved inwardly and the valve opening is reduced to ensure that the valve petals close properly. However, other changes in the path of the supporting member can be taken into account in the treatment of a diseased heart valve. For example, the path of the support member may be changed so that the radius of curvature increases locally. In addition, the path of the support member may be changed to introduce a recess or recess on the track of the support member. This means that the support member, if applied on the atrial side of the heart valve, may push the flaps towards the heart chamber, and thus prevent the flaps from falling out when expanding into the atrium of the heart.

According to a first embodiment of the invention, the limiting member can be shaped in such a way as to regulate the rate of degradation in the patient's body. The limiting member may be adapted for degradation within a few weeks after implantation in the patient. This means that the support members will be firmly attached to the valve during the degradation time of the limiting member. The period of degradation of the limiting member can be adjusted by the thickness and material of the limiting member.

[0028] In accordance with all embodiments of the invention, the support member may be a first support member and the device may further comprise a second support member at least partially formed of said shape memory material and connected to said first support member. The second support member is configured to rest on the opposite side of the valve, whereby a portion of the valve tissue can be gripped between said first support member and the second support member.

[0029] Such a device having a first and a second support member is applied to the heart valve in a much easier manner than conventionally used annuloplasty rings. The device may be rotated at the location of the first and second support members on opposing sides of the valve. The support members grip the tissue of the valve between themselves and thereby at least partially fix the support members to the heart valve.

[0030] The first and second support elements act to support the valve tissue on opposing sides, for example, helping to ensure that the falling petals are properly closed. The first and second supporting members also function to remodel the valve after the limiting effect has been removed in order to bring the petals closer together, thereby helping the flakes to close properly.

[0031] The shape of the second support member can be controlled in the same manner as the shape of the first support member. Thus, when the limiting action is removed or the desired shape of the support members is active, both the first and second support members can change the path for bringing the valve tissue to them and remodeling the heart valve. Alternatively, only one of the support members is limited before receiving the desired track. However, this limitation may also prevent the other supporting members from fully accepting the desired track.

[0032] The first support member and the second support members may be in the form of a loop. As used herein, the term "loop-shaped" is to be understood as a curved shape that can be enclosed as a ring, circular, elliptical, or D-shaped, or in another closed form that may match the shape of the annulus. The term "loop-shaped" also refers to a curved shape that is open to form an arcuate shape such as a C or U-shape that includes the possibility of angular rotation of at least 180 ° so that the support member can abut against the valvular tissue. along the greater part of the annular shape of the valve. The term "in the shape of a loop" also applies to a curved shape, which makes it possible to overlap to form a part of a roll. [0033] The first loop-shaped supporting member can thus be continuous with the second loop-shaped supporting member to form a web-like shape. This makes it easier to rotate the support members to a position on opposite sides of the valve. The end of the coil shape can be fed to the commissar between the heart valve lobes, and the coil shape can be rotated such that the support members are located on opposite sides of the valve.

[0034] The first and second support members may be D-shaped. Such a shape corresponds to the shape of the vestibular annular valve and is therefore particularly useful in the treatment of atrial valves.

[0035] At least the opposing surfaces of the first and second support members may be given a roughness, using fabrics, coatings, knurling or the like to facilitate better engagement and retention of the support members on the valve tissue. The opposing surfaces may be rough in a configuration extending along the longitudinal direction of the loop-shaped support members. This means that the rough surface will serve to prevent the tissue from slipping by clamping the support members on opposite sides of the valve, demonstrating a low coefficient of friction for the support members intended to be rotated to a position where the members abut against the valve.

The outer limit of the second support member may be larger than the outer limit of the first support member. This means that the device, properly positioned in the heart valve, can be placed in such a way that the first and second support members are moved relative to each other on opposed sides of the valve. It has been found that such a system reduces the risk of rupture in the flakes which, during normal heart function, bends over the lower support member to open the valve. A possible explanation for this reduction in the risk of rupture is that, since the support members are moved relative to each other, the clamping between the first and second support members does not clearly define the radial position in which the valve folds folds on the lower support member.

When using the device in the atrial valve, the lower support member can now be placed near the annulus that is larger than the ventricular side. In this way, the device can also be adjusted to minimally affect the movement of the petals during normal heartbeat. In addition, the large lower support member provides for the support member to move around the tendons in the left chamber when inserting the device. However, it is not excluded that a reduced risk of rupture can be achieved instead of the outer boundary of the upper support member being larger than the outer boundary of the lower support member.

[0037] According to a second embodiment of the invention, the limiting member may be in the form of a reel. This means that the restriction member can be adapted to follow the shape on opposite sides of the heart valve to maintain a large radius of curvature of the support members on both sides of the valve.

[0038] The first and second supporting members may be wound around the limiting member to form a spiral having a generally coil shape. Thus, the limiting member is an inner coil core within the spiral. This core prevents the support members from receiving the desired radius. When the core degrades, the support members are able to receive a radius shape with reduced radius.

[0039] Many other alternative embodiments of the limiting member may be provided. For example, the limiting member may comprise one or more pins or bars extending between different positions on the support member and forcing these positions to be at a constant distance from each other. According to another alternative, the support member is tubular and the restriction member is elongated and slides out through the tubular support member to exert said limiting action. The restricting member can then be withdrawn from the interior of the tubular support member to free itself from the limiting effect.

[0040] According to one example, the first and second supporting members may be tubular. Alternatively, the first support member and the second support member may be U-shaped in a cross-section. The support member has a tubular cross-section or a U-shaped cross-section can be exposed to an external pressing force so that the cross-section enlarges in the radial direction.

[0041] The first and second supporting members may be adapted to receive a balloon inside to enlarge the cross-section of at least a portion of the support member. The balloon can be appropriately used for placing in the center of the support member, and after filling, provides an externally pressing force for enlarging the cross-section.

[0042] In another alternative, the first and second supporting members may be in the shape of a belt. The cross section of the belt can be increased by pulling the sides of the belt independently of one another.

[0043] The first and second supporting members may be formed from an eye-type construction. Such a structure may provide the opportunity to change the cross-section of the support member when the length of the support member is changed. Preferably, the first support member and the second support member may be stents.

[0044] According to one example, there is a method for improving the function of a heart valve consisting of a valve tissue comprising a ring and a plurality of petals to allow and prevent blood flow. The method includes inserting an implant device including a support member in which the implant device is inserted such that the support member resists on one side of the valve. The support member is arranged along a first path matching the shape of at least part of the annulus of the valve. The method further includes attaching the support member to the valve tissue to position the support member relative to the valve. The method further comprises activating the shape change of the support member such that the support member assumes the desired track for remodeling the heart valve.

[0045] According to the method, a device having an inherent ability to change its shape is inserted into the heart valve of a patient. The device is suitably attached to a heart valve matching the shape of at least part of the annulus of the valve before the shape change is activated. Thus, the method provides the possibility of allowing the support member to rigidly attach to the valvular tissue before the shape of the lesion takes place and, thus, before the support member will bring the valve tissue with them to a shape change for the remodeling of the heart valve. The method provides attachment of a support member that fits the shape of the widened annulus of the valve before remodeling such a heart valve. This means that the support member can be more easily attached to the valve, especially when working on a beating heart.

[0046] According to one embodiment, the support member is at least partially made of a shape memory material adapted to receive an activated shape and an inactivated shape, and the implant device further comprises a limiting member which is arranged to provide a limiting effect on the path of the member. supporting. The insertion includes feeding the shape memory material of the support member to an activated shape, so that the support member is positioned along the first path while the limiting member exerts a limiting effect on the support member. In this embodiment, the support member has an inherent desire to adopt the desired path. However, the point of time to change the shape of the support member is controlled by means of the limiting member so that

[0047] In this embodiment, the actuator includes removing the limiting action of the limiting member allowing the support member to receive the desired changed track.

[0048] The removal may comprise withdrawing the limiting member from the inserted implantation device. Thus, the restriction member can be arranged such that it can be retracted from the patient, leaving the support member in a position to receive the desired path.

[0049] Alternatively, the restriction element may be biodegradable and the removal may comprise leaving the support member and the limiting member in the patient to allow degradation to the limiting member and to remove the limiting effect. This means that the support member can be strongly anchored in the valve tissue by the hypertrophy of the endothelial cells, while the limiting member is degraded.

Thus, when the limiting member has degraded to release from the limitation on the support member, the support member will lead the valve tissue with it to adopt the desired path.

[0050] According to another embodiment, the support member has inherent adaptation to shape change, so that enlargement of the cross-section of at least a portion of the support member is associated with a shortening of the length of the support member. The actuator comprises widening the cross-section of the support member such that the support member is shortened and adopts the desired, changed track. In this embodiment, the support member does not change its shape until a force is applied to widen the cross-section of the support member. Thus, the shape change point of the support member is controlled so that the support member can be attached to the valve before it adopts the desired path.

The support member may be tubular or U-shaped, and the widening may include bringing the balloon in contact with at least a portion of the support member and inflating the balloon such that the cross-section of the support member is enlarged.

[0052] The support member may be a first support member and the implantation device may further include a second support member connected to the first support member. The insertion may further comprise placing said implant device such that the second support member resists on the opposite side of the valve, the second support member is disposed along a first track matching the shape of at least part of the valve annulus at said opposite side.

[0053] The attachment may partially include placing the first support member and the second support member relative to one another on opposite sides of the heart valve such that a portion of the valve tissue is gripped between the first support member and the second support member. The first and second supporting members can at least prevent slippage of the valve tissue in the clamp between the support members, and alter the ratio of the support members to the heart valve when securing the support members to the heart valve.

[0054] The actuator may comprise activating a change in the shape of the second support member such that the second support member also receives the desired, changed track to remodel the heart valve. This means that the heart valve is treated on both sides, and that the valve tissue clamp can be maintained after the support members have adopted the desired path.

The insertion step may include inserting the first end of the first support member through a portion of the valve tissue, rotating the implantation device to position the first support member on the first side of the valve, and placing the second support member on the opposite second side of the valve. The first supporting member and the second supporting member are therefore easily applicable on opposite sides of the valve.

[0056] The insertion step may further comprise inserting the implantation device into the patient's body within the catheter. Thus, the implantation device can be introduced in a minimally invasive way.

Brief Description of the Drawings [0057] The invention will now be described in more detail by way of example with reference to the accompanying drawings.

Fig. 1 schematically shows a heart patient shown in cross-section and a device according to the present invention schematically shown as mitral valve support.

Figure 1A is a cross-sectional view of the left ventricle showing the mitral valve in perspective.

Fig. 2 shows a perspective view of the device according to the first embodiment of the invention, wherein the first and second support members of the device are shown in an inactive form suitable for insertion into the patient's body. Fig. 3 shows a perspective view of the device of Fig. 2, in which the first and second support members have assumed an activated shape, but are limited by a limiting member.

Fig. 4 shows a perspective view of the device of Fig. 2, in which the first and second support members have taken the desired shape to be activated after being released from the restriction of the limiting element.

Fig. 5 is a perspective view of an alternative device according to the first embodiment of the invention.

Fig. 6 shows a perspective view of the device of Fig. 5 after attaining the desired activated shape.

Fig. 7 is a perspective view of yet another alternative device according to the first embodiment of the invention.

Fig. 8 is a perspective view of the device of Fig. 8 after attaining the desired activated shape.

Fig. 9 is a cross-sectional view of the device of Fig. 4.

Fig. 10 is a perspective view of the device according to one example, wherein the first and second support members of the device are shown in a first embodiment having a small cross-section.

Fig. 11 shows a perspective view of the device of Fig. 10, in which the cross-section has been enlarged and the first and second supporting elements take on an altered shape.

Figs 12a-c show cross-sectional views of the device of Fig. 10.

Fig. 13 is a perspective view of the device of the third example in which the device is in an unactivated form.

Fig. 14 is a perspective view of the device of Fig. 13, where the device is in the first activated form.

Fig. 15 is a perspective view of the device of Fig. 13, where the device is in the second form of the activated.

Fig. 16 shows a perspective view of the device according to the second embodiment of the invention, the device comprising only one supporting member. Fig. 17 is a perspective view of the device of Fig. 16, where the device has assumed a changed shape.

Figs 18a-b show partial cross-sectional views of the mitral valve and device according to the first embodiment of the invention during implantation of the device.

Fig. 19 shows a partially cross-sectional perspective view of the device according to the invention after being turned into a position.

Figs. 20a-b are cross-sectional views illustrating the attachment of the device to the heart valve.

Fig. 21 is a cross-sectional view of the implanted device of Fig. 18. Fig. 22 is a perspective view showing the implantable devices after degradation of the limiting member.

Detailed description of preferred embodiments Fig. 1 shows a patient 10 having a heart 12 shown in cross-section comprising a left ventricle 14 and a right ventricle 16. The concepts of the present invention are suitable for use, for 14. The mitral valve 18, as better shown in Fig. 1A, comprises a ring 20 and a pair of petals 22 and 24 that selectively allow and prevent blood flow to the left ventricle 14. It should be noted that the term valvular tissue is widely used in the present disclosure with reference to drawings. The principles of the invention also apply to any valve tissue such as ring tissue, flap tissue or tissue of any attached vessel. The flakes 22 and 24 are supported to align the tendon strings or tendons 26, 28 extending upwardly from the individual papillary muscles 30, 32. The blood flows into the left ventricle 14 through the mitral valve 18 and is removed during the subsequent contraction of the heart 12 through the valve 34. It should be noted that the present invention is also applicable to tricuspid valves. [0059] The device 40 according to the first embodiment of the present invention is shown in Figs. 2-4. The device includes first and second support members 42, 44. The first support member 42 is continuous with the second support member 44. The first and second support members 42, 44 are made of a shape memory material such as a foot based, e.g., Nitinol , copper-zinc-aluminum alloys,

[0060] The first and second support members 42, 44 have an inactivated shape and an activated shape. In the inactive shape, the support members 42, 44 are flexible and can be easily deformed. In the activated shape, the support members 42, 44 have a strong desire to get the desired pre-programmed shape. The support members 42, 44 may introduce a shape activated by exposure to a temperature above the transition temperature. Thus, the device 40 can be inserted in a minimally invasive way, the support member 42, 44 remains in an inactivated shape. The device 40 can then take on the desired shape when placed in a suitable position in the patient through the support members 42, 44 brought into its activated shape. Supporting members 42, The limiting member 45 is in the form of a reel and is formed of a biodegradable material, such as a polyglycol acid based material, copolymers of glycolic acid and lactic acid, or various lactide polymers. The biodegradable material will degrade or absorb after implantation in the patient. The period of degradation depends on the specific material and the thickness of the limiting member 45. Thus, this can be controlled by the structure of the limiting member 45.

[0062] As shown in Figs. 2-3, the first and second support members 42, 44 may be wound around the limiting member 45. This allows the limiting member 45 to limit the support members 42, 44 from the assumption of a pre-programmed shape. As shown in Fig. 2, the device 40 may be disposed generally in the elongated shape in the shape of an inactivated support member 42, 44. This elongated shape is suitable for accommodating the device 40 within the catheter for insertion into the patient's body. The coil-shaped restriction member 45 is thus pulled outwardly to allow its insertion inside the catheter.

[0063] In Fig. 3, the device 40 is shown with support members 42,44, which are in the shape of an activated state. The restriction member 45 has assumed its coil shape and prevents the retaining members 42, 44 from being fully activated. The restriction member 45 compels the supporting members 42, 44 to follow the shape of the coil having a greater radius of curvature than the pre-programmed shape.

[0064] After implantation to the patient, restriction member 45 will be degraded. In Fig. 4, the device 40 is shown after the limiting member has been degraded, and the first and second support members fully take on an activated, pre-programmed shape. The first and second support members 42, 44 now form a general twisted configuration in the form of a spiral or a pendant-type configuration with two loops.

[0065] Alternatively, the limiting member 45 may be withdrawn during implantation of the device 40 in a patient. Thus, the limiting member 45 can be retracted when the first and second support members 42, 44 have been positioned correctly, allowing the support members 42, 44 to fully support the activated shape.

This means that the surgeon can see the result of the complete shape change of the support members 42, 44 during implantation of the device 40 and can directly receive an indication of the success of the operation.

[0066] In a further alternative method, the restriction member can be implanted as one or more rods extending between different positions on the first and second support members 42, 44. These rods can thus maintain the positions on the support members 42,44 at a predetermined distance from each other. , and thus prevent the support members 42, 44 from becoming fully activated. The rods may be made from a biodegradable material as described above. Alternatively, the rods may be detached from the support members 42, 44 and removed during implantation, or the rods may be cut off during implantation to remove the restraining effect of these rods.

[0067] According to the alternative embodiment shown in Figs. 5-6, the device 340 includes first and second support members 342, 344. The first supporting member 342 is continuous with the second supporting member 344. The first and second supporting elements 342 344 are formed of a shape memory material. The first and second supporting members 342, 344 are coated with a biodegradable coating 345. During manufacture of the device 340, the first and second supporting members 342, 344 may be immersed in a biodegradable material being in a liquid state. The first and second support members 342, 344 may be immersed in a biodegradable material in an inactivated elastic state, while being in the form of a coil that may fit into the device in the center of the heart, that the first and second supporting members may correspond to the shape of at least part of the annulus of the valve on opposite sides of the valve. The first and second support members 342, 344 can thus be embedded in the biodegradable coating 345. After the biodegradable cover 345 is degraded by the patient, the first and second support members 342, 344 can take the form of an activated, whereby a reduced radius of the web shape is obtained, as shown in Fig. 6.

[0068] According to yet another alternative embodiment shown in Figs. 7-8, the device 440 includes first and second support members 442, 444. The first supporting member 442 is continuous with the second support member 444. The first and second supporting members 442, 444 are made of shape memory material. The first and second supporting members 442, 444 are tubular. The device 440 further comprises an elongate restriction member 445, which can be arranged as extending inside the tubular first and second support members 442, 444. The restriction member 445 can be pushed to extend through the first and second support members 442, 444, in order to impose the first and second supporting member 442, 444 of a large radius shape.

[0069] The second support member 44 has an outer limit that is larger than the outer boundary of the first support member 42. The support members 42, 44 have respective shapes, the second supporting member 44 being on an enlarged scale than the first supporting member 42. This is advantageous a feature for forming a valve tissue clamp between the first and second support members 42, 44, as will be described below with reference to Fig. 14. The end of the second support member 44 and the respective end of the limiting member 45 that will guide the roll when inserting the device 40 at the valve, has a greater slope than the rest of the roll. This means that the leading end of the coil, when rotated to the right position in the valve, will protrude from the closest contact with the valvular tissue, and therefore, the risk,

[0070] The device 40 is shown in cross-section in Fig. 9. The first and second supporting members 42, 44 have a circular shape in cross-section. The opposed surfaces 46 of the first and second support members 42, 44 provide a clamp for grasping the valvular tissue between them. A circular cross-section is also beneficial in the formation of a valve tissue clamp that does not damage the flakes during their movement associated with normal heart function, as will be described in more detail below with reference to Fig. 21.

[0071] The device 140 according to the example is shown in Figs. 10-12. The device 140 includes first and second support members 142, 144. The first supporting member 142 is continuous from the second support member 144. The first and second support members 142, 144 are formed from a mesh or mesh type structure such as stents.

[0072] The first and second support members 142, 144 have inherent adaptation so that the increase in the cross-section of at least a portion of the support member 142, 144 is related to the shortened length of the support member 142, 144. This shortening is achieved in that the structure of the eyelet type, after extension in cross-section, pulls the ends of the supporting members 142, 144 towards each other.

[0073] The support members 142, 144 show a change in shape that can be controlled. The shape change will not take place unless a force is applied to increase the cross-section of at least a portion of the first and second support members 142, 144. This means that one example, as well as the first embodiment, provides the possibility of placing the device relative to the heart valve and then control the time point when the device placed on the valve intends to change shape.

[0074] In Fig. 10, the device 140 is shown with support members 142, 144 arranged in a first shape suitable for attachment to the heart valve. In this first shape, the support members 142, 144 are compatible with the shape of the valve annulus, so that the support members 142, 144 can be attached to the ring along the entire course of the support members 142, 144. The first and second support members 142, 144 form the general coil configuration in the form of a spiral or key with a ring type configuration with two loops, so that the support members 142, 144 can rest on opposite sides of the valve.

[0075] In Fig. 11, the device 140 is shown after the support members 142, 144 have been exposed to a force increasing the cross-section of the support members 142, 144. The increased cross-section has forced the support members 142, 144 to shorten first and second support members. 142, 144 now form a coaxial configuration with a reduced radius of curvature to adapt to the shortened length of the support members 142, 144.

[0076] Figs. 12a-c illustrate different cross-sections of the first and second support members 142, 144. In Fig. 12a, the support members 142, 144 are tubular and have a circular cross-section. In Fig. 12b, the support members 142, 144 have a U-shaped cross-section. Both of these cross-sections are suitable for receiving an inflatable balloon within the cross-sectional structure. Filling the balloon will therefore force a cross-section to the radial enlargement. In Fig. 12C, the support members 142, 144 are in the shape of a belt having a linear cross-section. This cross-section can be increased by independently pulling the tape edges.

[0077] The device 540 according to the example is shown in Figs. 13-15. The device 540 includes first and second support members 542, 544. A first supporting member

542 is continuous with the second support member 544. The first and second supporting members 542, 544 are made of shape memory material. The shape memory material is machined to form the first and second active shape. The first and second supporting members 542, 544 can thus take two different shapes depending on the temperature in the device 540. In the inactivated shape, as shown in Fig. 13, the device 540 is flexible and can be arranged in an elongated form to facilitate insertion of the device into the device. patient's heart using a catheter. The device 540 can be cooled during the insertion of the catheter in order to keep its shape inactivated. The device 540 can then be heated to a first temperature by using body temperature. Next, the device 540 is fed to the first activated shape as shown in Fig. 14 to form a coil with a large radius suitable for receiving the first and second support members 542, 544 in contact with opposite sides of the heart valve and positioning the support members 542, 544 relative to the valve ring. . The device 540 can be further heated to a second temperature by further using the body temperature. Then, the device is fed to the second activated form, as shown in Fig. 15. The device 540 in the second activated form forms a coil shape with a smaller radius suitable for reducing the radius of the annulus. 14 forming a coil shape with a large radius suitable for receiving the first and second support members 542, 544 in contact with opposite sides of the heart valve and positioning the support members 542, 544 relative to the valve annulus. The device 540 can be further heated to a second temperature by further using the body temperature. Then, the device is fed to the second activated form, as shown in Fig. 15. The device 540 in the second activated form forms a coil shape with a smaller radius suitable for reducing the radius of the annulus. 14 forming a coil shape with a large radius suitable for receiving the first and second support members 542, 544 in contact with opposite sides of the heart valve and positioning the support members 542, 544 relative to the valve annulus. The device 540 can be further heated to a second temperature by further using the body temperature. Then, the device is fed to the second activated form, as shown in Fig. 15. The device 540 in the second activated form forms a coil shape with a smaller radius suitable for reducing the radius of the annulus. by further using body temperature. Then, the device is fed to the second activated form, as shown in Fig. 15. The device 540 in the second activated form forms a coil shape with a smaller radius suitable for reducing the radius of the annulus. by further using body temperature. Then, the device is fed to the second activated form, as shown in Fig. 15. The device 540 in the second activated form forms a coil shape with a smaller radius suitable for reducing the radius of the annulus.

[0078] The device 240 according to the second embodiment of the present invention is shown in Figs. 16-17. The device 240 comprises only one support member 242. The support member 242 is adapted to be placed on only one side of the heart valve.

[0079] The support member 242 may be formed of a shape memory material having an inactivated shape and an activated shape. In the inactive shape, the support member 242 has a strong desire in the direction of assuming a pre-programmed shape. The device 240 can be inserted in a minimally invasive manner, wherein the support member 242 is in an inactivated shape. The device 240 can then take the desired shape when placed in the appropriate position of the patient through the support member 242 brought into their activated form. The device 240 may further include a limiting member (not shown) which is arranged to prevent the support member 242 from fully taking on the desired activated shape. The limiting member can thus control the temperature over time, when the support member 242 is fully brought into its desired activated shape. The support member 242 may be wound around the bounding member or the restriction member may extend between two positions on the support member fixing the distance between these positions.

[0080] The support member 242 may alternatively be formed from a mesh type or mesh type structure having an inherent fit to change the shape so that an increase in the cross section of at least a portion of the support member 242 is associated with a shortening of the length of the support member 242. The support member 242 represents a change in shape what can be controlled. The change of shape will not take place until the force for enlarging the cross-section of at least part of the support member 242 is applied.

[0081] According to a further alternative, the support member 240 may be formed of a shape memory material treated to form the first and second activated form.

[0082] In Fig. 16, the device 240 is shown with a support member 242 in a first shape conforming to the shape of the heart valve ring to be treated.

[0083] In Fig. 17, the device 240 is shown after the support member 242 has been allowed to change its shape to take the desired shape. Either the limiting action of the limiting member has been removed or the cross-section of the support member 242 has been enlarged to activate the shape change. The support member 242 has now changed shape to reduce the radius of curvature of the remodeling of the heart valve and to reduce the size of the annulus.

[0084] Referring now to Figs. 18-22, a method for repairing a heart valve using a device according to the first embodiment of the invention will be described below. The concept of this method can also be applied to a device according to a second embodiment that would be understood by a person skilled in the art. As described above, the shape change of the device can be activated in other ways, depending on the embodiment of the device. However, the point of time at which the shape change is activated can be controlled independently of which embodiment has been used. Thus, it can be seen that the device is securely attached to the heart valve before the shape changes so that the heart valve can be adequately renewed as will be described below.

[0085] First, access to the heart valve is obtained by means of a catheter by conventional techniques, including venipuncture and guiding the catheter through the vascular system to the heart. In Fig. 18a, the device 40 is shown when it is inserted into the mitral valve 18. The device 40 is carried in a catheter 50 that extends from the outside of the patient up to the heart. The device 40 can be pushed out of the catheter 50 by a gripping tool (not shown) passing through the catheter 50. After being pushed out of the catheter 50, the restriction member 45 assumes its coil shape. The end of the limiting member and the second support member 44 is supplied to the mitral valve hole 18 at the splitter between the flakes 22, 24 as shown in Fig. 18b. The end is led through the hole, and the device 40 is rotated by 360 degrees. Thus, the second support member 44 is rotated to a position on one side of the valve 18, while the first supporting member 42 is positioned on the opposite side of the valve 18.

[0086] The first and second support members 42, 44 are already brought into their shape activated by, for example, heating them above the transition temperature. Heating may be provided by the patient's body temperature, or by thermal energy transmitted via a conduit (not shown) in the catheter. This means that the first and second supporting members 42, 44 tend to take on a pre-programmed shape. The first and second supporting members 42, 44 on opposite sides of the valve will now be drawn towards each other for secure entrapment of the valve tissue between them. The restriction member 45 will prevent the first and second supporting members 42, 44 from fully receiving an activated shape and, hence, from reducing the radius of curvature of the web shape.

The support members 42, 44 are now positioned on opposite sides of the valve 18 to squeeze the valve tissue positioned between them to maintain the shape of the valve 18. The support members 42, 44 can have rough, opposed surfaces 46 to better maintain the flakes 22, 24 against slipping through this compression. This means that the position of the retaining members 42, 44 relative to the heart valve is pre-set.

[0088] The device 40 can now be attached to the valve 18 to enhance the attachment of the relative position between the support members 42,44 and the valve tissue. The support members 42,44 may include respective openings 54 through opposed support members for receiving separate connectors 56. Connectors 56 may be threaded or non-threaded studs and may be pushed into a position extending through openings in both support members and the valve tissue therebetween. The connector may have an end 58 with a diameter larger than the diameter of the holes 54 so that the connector 56 can not fall out through the opening 54. In this way, the device 40 is securely attached to the valve 18 to keep the annulus 20 in its transformed form as shown in FIG. Fig. 20a. Many alternative embodiments of connectors may be considered. As shown in Fig. 20a, the connectors 56 may have an end 60 with an expandable diameter to attach the connector 56 after it has been pushed through the openings 54. Alternatively, the connector 56 'may have a curved portion 60' to grip around one of the support members so that the connector 56 'can pass through the aperture 54 in one of the support member and around a second support member as shown in Fig. 20b. As further alternatives, the connectors may be clamps, sutures, or protrusions that are extendable with at least one of the support members to be connected to the valve tissue. as it has been pushed out through the holes 54. Alternatively, the coupler 56 'may have a curved portion 60' to grip around one of the support members such that the coupler 56 'can pass through the aperture 54 in one support member and around the other support member as shown in FIG. Fig. 20b. As further alternatives, the connectors may be clamps, sutures, or protrusions that are extendable with at least one of the support members to be connected to the valve tissue. as it has been pushed out through the holes 54. Alternatively, the coupler 56 'may have a curved portion 60' to grip around one of the support members such that the coupler 56 'can pass through the aperture 54 in one support member and around the other support member as shown in FIG. Fig. 20b. As further alternatives, the connectors may be clamps, sutures, or protrusions that are extendable with at least one of the support members to be connected to the valve tissue.

[0089] As shown in Fig. 21, the second support member 44 is slightly radially offset relative to the first support member 42. This means that the first and second support members 42, 44 are not placed directly on top of each other. Clamping between the first and second support members is therefore not clearly defined in the radial direction of the valve. This means that the clamping force between the support members is not focused on the specific radial position of the valve. As a result, the clamping force does not affect the movement of the petals during normal heart rate, and the risk of damage to the flakes when crimped is reduced. Supporting members are connected with each other so that the outer contour of the first support member 42 has a diameter corresponding to a line passing through the center of the second support member 44. Thus, the support members 42, 44 overlap somewhat so that the tissue is unable to move through the clamp and the shape of the valve is maintained. Furthermore, the cross-section of the support members 42, 44 is circular, which also provides a smooth contact between the support members and the valve tissue and further reduces the risk of tearing the petals.

[0090] Once the device 40 is placed in the heart valve forming the valve tissue clamp, the catheter 50 is withdrawn, and the device 40 is left to the patient. The limiting member will degrade in the patient's body over a period of several weeks. At this time, the support members 42, 44 will increase into the valvular tissue to further secure the support members 42, 44 to the valve. After the limiting member has been degraded, the support members 42, 44 are able to fully adopt the activated shape. Thus, the support members 42, 44 will reduce the radius of curvature of the web shape and will lead the clamped tissue of the valve to change shape so as to process the valve as shown in Fig. 22. The petals 22, 24 are thus brought closer to ensure that they can properly close the valve.

[0091] It should be emphasized that the preferred embodiments described herein are not limiting in any way, and that many alternative embodiments are possible within the scope of protection defined in the appended claims.

[0092] For example, access to the heart valve can be obtained endoscopically or as a result of an open heart surgery. In this case, the device 40 may have a coil shape already during insertion into the heart.

[0093] Many different shapes can be considered for loop-shaped support members. For example, the support members may have an elliptical, circular or D-shape. One support member or both of the support members do not need to angularly rotate through 360 ° in such a way as to have a C-shape or a U-shape instead. .

[0094] In addition, various changes in shape can be taken into account. The course of the support member can be altered so that the radius of curvature increases locally.

In addition, the course of the support member can be changed to introduce a recess or recess in the course of the support member.