MX2013011475A - Device and method for heart valve repair. - Google Patents

Abstract

The invention provides a device (50) and system for treating a heart valve having an anchor (54, 56) and one or more sutures attached to the anchor. The anchor has an expanded deployed configuration and a low caliber undeployed configuration. A delivery in a heart includes catheter and a needle slidable in the lumen of the catheter. The distal end of the catheter is inserted through the myocardium of the heart until the catheter tip is juxtaposed to the underside of the valve leaflet to be treated. The leaflet is then pierced with tip of the needle. The needle is pushed until the anchor in its undeployed configuration passes through the needle tip and is released from the catheter. The anchor is then brought to its deployed configuration on one or both surfaces of the valve leaflet.

Description

DEVICE AND METHOD FOR THE REPAIR OF THE VALVE OF THE HEART Field of the Invention This invention relates to medical devices, and more specifically to such devices for the treatment of heart valves.

Background of the Invention In the heart, the mitral valve is between the left atrium and the left ventricle, while the tricuspid valve is between the right atrium and the right ventricle. Each valve is composed of thin valves, which are located between the atrium and the ventricle. Valve leaflets are attached to the inner wall of the ventricle by a series of fibers called strings. In a healthy heart, when the ventricles contract during systole, the valves of the valve are attached and therefore prevent the reflux of blood from the ventricle to the atrium. When the ventricles relax during diastole, the valve opens to allow blood to flow from the atrium to the ventricle.

In the prolapse of the mitral valve, the cords have lengthened due to the myxoid degeneration in which the collagen in the structures of the heart is abnormally formed and produces a thickening, enlargement and redundancy of the leaflets and the cords. In addition, this process can cause the strings to break. Under these conditions, the prolapse of valves (they agitate backwards in the left atrium) during systole, when the ventricles contract, allowing the regurgitation of blood through the valve from the ventricle to the atrium. When severe, mitral regurgitation leads to heart failure and abnormal heart rhythms.

Mitral valve prolapse is the most common heart valve abnormality, affecting five to ten percent of the world's population. Considerable mitral regurgitation (moderate to severe) is much less common. For example, it was found in a study of two million untreated people in the United States that moderate or severe mitral regurgitation occurs in about 2-3 percent of people.

Surgery is necessary for people with severe mitral regurgitation. The guidelines of the American Heart Association and the European Society of Cardiology defines a person as having severe chronic mitral regurgitation based on echocardiogram measurements of the heart, heart valves and blood flow. Mitral valve surgery is a primary, open-heart, surgical procedure. The heart is stopped during the critical parts of the operation, while the oxygenated blood is pumped through the body with a heart-lung machine. A small part of the heart is then opened to expose the mitral valve.

Methods for the repair of non-invasive or minimally invasive mitral valve prolapse have been developed.

A method for the treatment of heart valve prolapse involves the union of the two leaflets along the free edges of the leaflets with a clip. A method and system for suturing valve leaflets is disclosed, for example, in the U.S. patent. 8,062,313 for Kimblad. A clip for securing the valves of the valve is disclosed, for example, in the U.S. Patent. 8,029,518 to Goldfarb et al.

Another method of valve repair involves the introduction of one or more artificial filaments to replace the torn cords. The filaments, sometimes referred to as "neo-strings", are attached in a end to a valve leaflet and at the other end to the cardiac tissue. A system of this type is described, for example, in the US patent. 8,043,368 for Crabtree. These methods require the reliable determination of the required length of the neo-strands to be introduced, which can be difficult to obtain in a beating heart. In most systems of this type it is difficult to adjust the lengths of the neo-strings after deployment.

Brief Description of the Invention In one of its aspects, the present invention provides a device for the treatment of a mitral or tricuspid valve. The device of the invention comprises an anchor having an expanded configuration in which the anchor is implanted on one or both sides of the prolapse area of a valve of the valve to be treated, and a configuration of low caliber in which the anchor is supplied to the site of its deployment. One or more sutures are attached to the anchor. After deployment of the anchor in the valve leaflet being treated, the sutures pass through the wall of the ventricle and are then sewn out of the wall of the ventricle to function as prosthetic cords, as explained below. The appropriate length of artificial cords can be obtained under echocardiography.

The anchor can have any shape that allows the anchor to be applied to one or both of the leaflet surfaces.

In its second aspect, the present invention provides a delivery system for supplying the device of the invention to the site of its deployment in the body. The delivery system comprises a needle in which the device of the invention can be inserted with the anchor in undeployed configuration. The delivery system further comprises a catheter sized to receive the needle, and a pusher that is used to push the device through the needle, as explained below.

In use, the device of the invention in its undeployed configuration is inserted into the needle and the needle is inserted into the catheter or thess. The tube is inserted through an incision in the chest, and into the ventricle through the apex until the guided echo tip of the tube is just below the prolapsed area of the leaflet to be treated. The device is then pushed into the needle until the tip of the needle pierces the valve leaflet of the valve being treated. The anchor is then released from the needle and allowed to reach its configuration deployed on one or both sides of the leaflet being treated. The achievement of the deployed configuration can occur spontaneously after the release of the tube anchor (for example, if the anchor is made of an elastically flexible material), or at a temperature transition, in the case of an anchor formed from an alloy with shape memory as Nitinol. The anchor may be coated, for example, pericardium or with various drugs, such as antibiotics.

After deployment of the anchor, the sutures are tied outside the wall of the left ventricle to allow the sutures to function as prosthetic cords.

Therefore, in one of its aspects, the invention provides a device for the treatment of a heart valve, comprising: (a) an anchor having an expanded expanded configuration and an undeployed low-caliber configuration; Y (b) one or more sutures attached to the anchor. In the device of the invention, the anchoring portion may comprise a central axis from which two or more wire loops emerge.

The anchor in the deployed configuration may comprise a first set of one or more loops of wire extending in a first plane and a second set of one or more loops of wire not extending in the foreground. The second set of wire loops can be bent towards the foreground.

In the undeployed low-gauge configuration, the first set of loops may collapse away from the filaments and the second set of loops may be collapsed towards the filaments.

The anchor may comprise an elastically flexible wire ring and the anchor may further comprise one or more transverse elements in the wire ring.

The anchor may comprise a wire rod and the sutures may be attached to the wire rod.

In another of its aspects, the invention provides a system for the treatment of a heart valve, comprising: (a) A device for the treatment of a heart valve, comprising: (i) an anchor having an expanded expanded configuration and an undeployed low-caliber configuration; Y (ii) one or more sutures attached to the anchor; (b) a delivery catheter having a catheter lumen having a proximal end and a distal end; Y (c) a slidable needle in the lumen of the catheter, the needle having a lumen of the needle sized to receive the device in the low caliber configuration of the device, the needle having in addition a sharp tip.

The system of the invention may comprise a bar configured to push the device in the lumen of the needle towards the distal end of the catheter. The distal end of the catheter may be provided with a spiral wire.

The distal end of the catheter may be provided with an inflatable balloon that is visible on echocardiography.

The invention also provides a method for the treatment of a heart valve, comprising: (a) providing a system for the treatment of a heart valve, comprising: i) A device for the treatment of a heart valve, comprising: an anchor having an expanded expanded configuration and a deployed configuration of low caliber, and one or more sutures attached to the anchor; ii) a delivery catheter having a catheter lumen having a proximal end and a distal end; iii) a slidable needle in the lumen of the catheter, the needle having a needle lumen sized to receive the device in the low gauge configuration of the device, the needle having, in addition, a sharp tip, and iv) a bar configured to push the device in the lumen of the needle towards the distal end of the catheter. (b) inserting the device into the supply system; (c) inserting the distal end of the catheter through the myocardium of the heart, until the tip of the catheter is juxtaposed to the lower part of the leaflet; (d) pierce the valve with the sharp tip of the needle; (e) pushing the bar towards the tip of the needle until the anchor in its undeployed configuration passes through the tip of the needle and is released from the catheter; (f) bringing the anchor to its configuration deployed on one or both surfaces of the valve leaflet.

Brief Description of the Drawings In order to understand the description and to see how it can be carried out in practice, modalities will now be described, by way of non-limiting example, with reference. to the attached drawings, in which: Figure 1 shows a device for the treatment of a valva of the heart valve from a first perspective according to an embodiment of the invention; Figure 2 shows the device of figure 1 of a second point of view; Figure 3 shows the device of Figure 1 in an undeployed configuration; Figure 4 shows a device having a wire loop for the treatment of a valva of the heart valve according to another embodiment of the invention; Figure 5 shows the device of Figure 4 in an undeployed configuration; Figure 6 shows a device having a bar for the treatment of a valva of the heart valve according to another embodiment of the invention; Figure 7 shows the device of Figure 6 in an undeployed configuration; Figure (8) shows a delivery system for supplying and deploying a device of the invention; Figure 9a shows the delivery of a device of the invention to a valve leaflet of the heart; Figure 9b shows the perforation of a valve leaflet of the heart with a needle; Figure 9c shows a first step in the deployment of a device of the invention in a heart valve; Figure 9d shows a second step in the deployment of a device of "the invention in a heart valve; Figure 9e shows a device of the invention after the implementation of a heart valve and the removal of the delivery device.

Detailed Description of Modalities Figures 1 to 3 show a device (50) for the treatment of a heart valve according to an embodiment of the invention. The device (50) has an expanded configuration shown from different perspectives in Figures 1 and 2 wherein the device (50) is deployed in a heart chamber, as explained below. The device (50) also has an undeployed low gauge configuration, shown in Figure 3, which is used during the delivery of the device (2) to a heart valve.

The device (50) has an anchoring portion (51) comprising a central cone (52) from which a plurality of loops (54) and (56) extend. The cone (52) is a tube that is completely closed at the distal end of the tube, for example, by plugging the distal end of the tube with an adhesive (53). In the embodiment of figures 1 to 3, there are loops (12). This is only by way of example, and the device (50) can have any number of loops that are required in any application. The device (50) includes six coplanar loops (54) and six other loops (56) located below the plane of the loops (54) and curving upwards towards the plane of the loops (54). The loops 54 and 56 are made from a single piece of wire, which may be, for example, a Nitinol ™ wire having a diameter of about 0.2 mm. The anchorage can be covered with bovine pericardium in order to improve the integration of the anchor in the valve.

Two sutures (58) and 60 are attached at one end to the cone (52) and extend away from the anchoring portion. The sutures (58) and (60) may be, for example, GoreTex ePTFE fibers.

In the compressed configuration shown in Figure 3, the flat loops (54) and (56) are folded up away from the cone (52) and the filaments (58) and (60), while the curved loops (56) they fold down towards the cone and the filaments (58) and 60, so that the device (50) achieves a low gauge suitable for delivery at the site of its deployment in a heart chamber.

Figures 4 and 5 show a device (2) for the treatment of a heart valve according to another embodiment of the invention. The device (2) has an anchoring portion (4) comprising an elliptical wire ring, with one or more transverse elements. Two transverse elements (6) and (8) are shown in figures 4 and 5. This is only by way of example, and the anchor (4) can be any number of transverse elements. The device (2) has an expanded configuration shown in Figure 4 in which the device (2) is deployed in a heart chamber and underextended low caliber configuration, shown in Figure 5, which is used during the supply of the device (2) to a heart valve. A pair of sutures (12) and (14) are linked to one end of the transverse elements (6) and (8). The other ends of the sutures (12) and (14) are free before deployment of the device (2) in a heart valve, as explained below. The sutures can be, for example, Gortex sutures.

The anchor (4) is formed from a deformable material that allows the anchor (4) in the The deployed configuration (Figure 4) collapses in the undeployed configuration (Figure 5) prior to the delivery of the device, and then to recover the deployed configuration after the correct position in the heart. The anchor cables (4) can be manufactured, for example, from a biocompatible elastic or spring-type material, such as silicone rubber, stainless steel or Nitinol. Alternatively, the anchor cables (4) can be made of a shape memory alloy (one-way or two-way), in which case the anchor (4) can alternate between the deployed configuration and the undeployed configuration. a suitable transition of the temperature, as is known in the art of alloys with shape memory. The anchorage can be covered with bovine pericardium in order to improve the integration of the anchor in the valve.

Figures 6 and 7 show a device (60) for the treatment of a heart valve according to another embodiment of the invention. The device (60) has an anchor portion (62) comprising wire rod (64). The bar (64) may be made, for example, from a biocompatible elastic or spring-type material, such as silicone rubber, stainless steel or Nitinol. The device (60) has an expanded configuration shown in figure 6 in which the device (60) is deploin a heart chamber and underextended low caliber configuration, shown in Figure 7, which is used during the delivery of the device (60) to a heart valve. A pair of sutures (64) and (66) are linked to the bar (-64) in the center of the bar (64). The other ends of the sutures (64) and (66) are free before deployment of the device (60) in a heart valve, as explained below. The sutures can be, for example, Gortex sutures. The bar (64) can be covered with bovine pericardium in order to improve the integration of the anchor in the leaflet.

Figure 8 shows the device (50) of Figures 1 and 2 in its undeploconfiguration inserted in a supply system (20). The delivery system (20) comprises a delivery catheter (23) having a proximal end (21) and a distal end (29), which is visible under echocardiography. The delivery system (20) also comprises a needle (22) into which the device (50) is inserted in its undeploconfiguration. The needle (22) terminates at its distal end in a sharp tip (24) which is used to pierce the valve leaflet of the valve being treated during the deployment of the device (2). The supply system (20) further comprises a push bar (26) sized to be slidable inside the needle (22). The bar (26) is longer than the needle 22 so that it is accessible at the proximal end of the delivery system (20) during the delivery of the device (50). The bar (26) is used to push the device (50) through the tip (24) of the needle (22) during the deployment of the device (50). The catheter (23) terminates in a blunt tip (25) at its distal end. Attached to the unsharpened point (25) is a wire spiral (27) configured to be screwed into the bottom of the valve leaflet being treated, as explained below.

Also at the distal end of the catheter (23) is a toroidal balloon (28) which is visible on echocardiography. A delivery tube is provided with a Luer fitting for attaching a syringe containing a liquid such as sterile water or saline. The liquid is supplied to the balloon (28) through the supply tube (100) and enters the balloon (28) through one or more openings (102). As the balloon (.28) is filled with liquid, and residual air in the balloon or excess liquid is forced out of the balloon (28) through a second set of one or more openings (104) in a return tube (106) to the proximal end of the catheter (23). The supply tube (100) and the return tube (106) can be continuous with each other. This allows the complete elimination of any air in the balloon (28).

The deployment of the device of the invention for the treatment of a prolapse of the mitral valve will now be described with reference to the device (50) shown in Figures 1 and 2, it being evident that other embodiments of the device of the invention can originate in a similar manner. .

Figure 9 shows a method for deploying the device (50) for the treatment of a prolapse of the mitral valve. Figure 9a shows a sectional view of a left ventricle (30) including a leaflet of the posterior mitral valve (32) and a leaflet of the anterior mitral valve (34). The malocclusion of the leaflets (32) and (34) is evident by a space (36) between the leaflets due to the elongation of the cords (35). For the deployment of a device (50), the device (50) is inserted into the supply system (20), as shown in figure (8). The tip (25) of the catheter (23) is inserted through the myocardium (38), until the tip of the catheter (25) is juxtaposed to the lower part of the leaflet (32). The movement of the delivery system in the left ventricle, and the deployment of the device can be controlled by echocardiography of the balloon (23). Bleeding can be controlled by a string of bag stitches. With the heart still beating or during the use of stimulation Frequently from the heart, the catheter (23) is rotated so that the spiral wire (27) is screwed into the lower part of the valve leaflet (32). Next, as shown in Figure 9b, the sharp point (24) of the needle (22) is made to pierce through the leaflet (32).

Now, as shown in Fig. 9c, the bar (26) is pushed towards the tip (24) of the needle causing the anchor region (51) in its undeployed configuration to pass through the tip of the needle ( 24) and released from the catheter (23) with the superior loops (54) positioned in the left atrium above the leaflet (32) and the curved loops (56) positioned in the ventricle below the leaflet (32). At this point, the anchor (51) is allowed to reach its deployed configuration (Figure 9d). This can occur spontaneously after the release of the tube anchor (22) (for example, if the anchor is made of an elastically flexible material), or at a temperature transition, in the case of an anchor and formed from of a shape memory alloy such as Nitinol. As the delivery system (20) is withdrawn from the left ventricle, the sutures (12) and (14) are pulled down the appropriate length of neo-strings can be monitored by echocardiography. The sutures continue to be thrown until the leaflets are juxtaposed, and space (36) is eliminated (figure 9e), so that mitral regurgitation has been corrected. When the correct length of the sutures has been determined, the sutures are fixed in the myocardium (38), so that the sutures can function as prosthetic cords.

Claims (13)

1. A device for the treatment of a heart valve, comprising: (A) an anchor having an expanded expanded configuration and an undeployed low-caliber configuration; Y (B) one or more sutures attached to the anchor.

2. The device according to claim 1, characterized in that the anchoring portion comprises a central cone from which two or more wire loops extend.

3. The device according to claim 1 or 2, characterized in that the anchor in the deployed configuration comprises a first set of one or more wire loops that extend in a first plane and a second set of one or more wire loops that do not they are located in the foreground.

4. The device according to claim 3, characterized in that the second set of wire loops are curved towards the first plane.

5. The device according to any of claims 2 to 4, characterized in that the undeployed configuration of low caliber, the first set of loops collapsed away from the filaments and the second set of loops collapses towards the filaments.

6. The device according to claim 1, characterized in that the anchor comprises a resilient flexible wire ring.

7. The device according to claim 6, characterized in that the anchor further comprises one or more transverse elements in the wire ring.

8. The device according to claim 1 or 2, characterized in that the anchor comprises a wire rod and the sutures are attached to the wire rod.

9. A system for the treatment of a heart valve, comprising: (a) A device for the treatment of a heart valve, comprising: (i) an anchor having an expanded expanded configuration and an undeployed low-caliber configuration; Y (ii) one or more sutures attached to the anchor; (b) a delivery catheter having a catheter lumen having a proximal end and a distal end; Y (C) a slidable needle in the lumen of the catheter, the needle having a lumen of the needle sized to receive the device in the low caliber configuration of the device, the needle having in addition a sharp tip.

10. The system according to claim 9, further comprising a bar configured to push the device in the lumen of the needle toward the distal end of the catheter.

11. The system according to claim 9 or 10, characterized in that the distal end of the catheter is provided with a spiral wire.

12. The system according to claim 9 or 10, characterized in that the distal end of the catheter is provided with an inflatable balloon that is visible on echocardiography.

13. A method for the treatment of a heart valve, comprising: (a) providing a system for the treatment of a heart valve, comprising: i) A device for the treatment of a heart valve, comprising: an anchor that has an expanded expanded configuration and an undeployed low-caliber configuration, and one or more sutures attached to the anchor; ii) a delivery catheter having a catheter lumen having a proximal end and a distal end; iii) a needle slidable in the catheter lumen, the needle having a needle lumen sized to receive the device in the low gauge configuration of the device, the needle having, in addition, a sharp tip, and iv) a bar configured to push the device in the lumen of the needle towards the distal end of the catheter. (b) inserting the device into the supply system; (c) inserting the distal end of the catheter through the myocardium of the heart, until the tip of the catheter juxtaposes to the lower part of the leaflet; (d) pierce the valve with the sharp tip of the needle; (e) pushing the bar towards the tip of the needle until the anchor in its undeployed configuration passes through the tip of the needle and is released from the catheter; (f) bringing the anchor to its configuration deployed on one or both surfaces of the valve leaflet.