HK40009694B - Method and device for treatment of valve regurgitation - Google Patents

Description

Methods and devices for treating valvular regurgitation

This application is a divisional application of a Chinese invention patent application filed on June 13, 2014, with application number 201480043690.7, entitled “Method and Device for Treating Valvular Regurgitation.” This Chinese invention patent application is a Chinese national phase application of international application number PCT/IB2014/002155.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application No. 61/956,683, filed on June 14, 2013 (Attorney Docket No. 41702-703.101); U.S. Provisional Patent Application No. 61/963,330, filed on December 2, 2013 (Attorney Docket No. 41702-703.102); and U.S. Provisional Patent Application No. 61/982,307, filed on April 21, 2014 (Attorney Docket No. 41702-703.103), the entire disclosures of which are incorporated herein by reference.

Background Art

1. Field of the Invention. The present invention relates generally to medical devices and methods. More particularly, the present invention relates to prosthetic devices and methods for improving the function of prolapsed cardiac and other circulatory valves.

Mitral regurgitation (MVI), whether organic (primary) or functional (secondary), such as but not limited to prolapse, regurgitation, and flutter, is a heart valve disease characterized by displacement of abnormally thickened mitral valve leaflets into the left atrium during systole, which may result in malcoaptation of individual valve leaflets and valvular leakage under back pressure. There are various types of MVI, broadly classified as typical and atypical. In its atypical form, MVI carries a lower risk of complications, and MVI can often be kept to a minimum by careful diet. In severe cases of typical MVI, complications include mitral regurgitation, infective endocarditis, congestive heart failure, and in rare cases, cardiac arrest, which generally results in sudden death. The aortic valve may also be affected by prolapse, and valves of the venous circulation may be affected by similar conditions, which may result in chronic venous regurgitation caused by damaged or "incompetent" valves characterized by malcoaptation.

It would be desirable to provide devices and methods for improving valve function in patients suffering from any of the conditions identified above, and in particular, to provide devices and methods for improving coaptation of heart valves, including both the mitral and aortic valves, as well as venous valves. At least some of these objectives will be met by the present invention as described below.

2. Background Art U.S. Patent Nos. 6,419,695, 6,869,444, and 7,160,322, and U.S. Patent Publication Nos. 2012/0197388 and 2013/0023985 all have disclosures relevant to the present invention.

Summary of the Invention

A description of prosthetic valve devices and methods of implantation is provided. The present invention generally provides medical devices, systems, and methods that are often used to treat mitral regurgitation and other valvular diseases, including tricuspid regurgitation.

The artificial valve device is composed of a single leaflet, which is sutured to a support ring frame, struts or arc-shaped structure. The ring frame (hereinafter referred to as the device ring) is radially self-expandable so that it can expand against the wall of the atrium. The valve device leaflet (hereinafter referred to as the device body) is made of pericardium or other biological or artificial materials and is shaped to be similar to the native target valve leaflet. The size of the device body is larger than the target leaflet, so that the device body significantly overlaps after implantation.

The invention described herein generally comprises a percutaneous transcatheter delivery system, a coaptation assist device, and the implantable device body is capable of assuming both a delivery configuration and an operational configuration; the delivery configuration having a size sufficiently small to enable delivery to an implantation site via a percutaneous transcatheter.

The device ring is typically made of metal (e.g., nickel-titanium alloy), polymer (e.g., polyurethane), or organic material (e.g., pericardium). At the treatment site, the device ring is typically secured to the annular base of the target valve by an anchor, which may be part of the device itself or separate from the device.

The device body is typically made of a synthetic material (e.g., polyester or polyurethane) or an organic material (e.g., pericardium), and in some embodiments has an embedded skeleton made of metal, synthetic material, or organic material, and in some embodiments has a specially designed lower crosspiece to prevent the device body from prolapsing during systole.

The device body is typically positioned in the atrioventricular direction along the blood flow path similar to the leaflets of a native valve to move back and forth between a valve-open configuration and a valve-closed configuration.

During implantation, the device ring should be positioned closely above the target valve orifice from the atrial side (e.g., via a transseptal approach). After the device is inserted, the device body leaflets move synchronously with the target valve leaflets within the bloodstream. After the target valve closes during systole, overlap of the device body will be prevented by the edge of the contralateral leaflet of the target valve. The device thus overlaps the effective regurgitant area (ERO) and minimizes or eliminates valvular regurgitation.

In order to close or reduce the gap caused by poor coaptation of the native leaflets, the device body will be positioned between the native leaflets, thereby providing a surface for at least one of the native leaflets to rest against the coaptation, while effectively replacing the function of the second native leaflet in the valve area, which will be occluded during systole.

Among other uses, the coaptation assist devices, device body implants, and methods described herein can also be configured to treat functional and/or degenerative mitral regurgitation (MR) by creating an artificial coaptation zone within which at least one of the native mitral valve leaflets can seal. The structures and methods herein will be primarily tailored to this application, but alternative embodiments can be configured for use in other heart valves and/or body valves, including the tricuspid valve, valves of the peripheral vascular system, the inferior vena cava, and the like.

In a first specific aspect, the present invention comprises a prosthetic valve coaptation assist device comprising an anchor configured for attachment to a native valve annulus and a single valve assist leaflet attached to the anchor, and the single valve assist leaflet being configured to rest against an upper surface of a first native valve leaflet when the anchor is attached to the native valve annulus. The single valve assist leaflet is sufficiently flexible that it will move in unison with the first native valve leaflet and will coapt with a second native valve leaflet in response to blood flow through the valve. In this way, valve prolapse can be alleviated and fluid leakage minimized.

In some embodiments of the prosthetic valve coaptation assist device, the anchor is configured to self-expand to attach to the native valve annulus. In other embodiments, the anchor can be configured to be sutured to the native valve annulus. For both self-expanding anchors and sutured anchors, the anchor can be further configured to fully or partially circumscribe the valve annulus. Anchors that partially circumscribe the valve annulus will often have barbs or other tissue penetrating elements that help hold the anchor in place, although barbs can also be included in fully circumscribed anchors.

The anchors can be formed of metal, polymers, or other biocompatible materials that have sufficient strength to remain attached to the valve annulus for an indefinite period after implantation. The valve auxiliary leaflets will typically be formed of the same type of flexible materials that can be used in artificial heart valves, such as tissue, for example, pericardium that has been treated to improve stability, and various synthetic polymers. The valve auxiliary leaflets can also be reinforced with metal or polymer reinforcement structures attached to all or a portion of either or both surfaces of the leaflet.

In a second specific aspect of the present invention, a method for promoting valve coaptation in a patient includes identifying a prolapsed valve in the patient, for example using conventional ultrasound or other imaging techniques. A single artificial valve auxiliary leaflet is implanted above the upper surface of a first native leaflet of the prolapsed valve. The single valve auxiliary leaflet moves in unison with the first native leaflet and will coapt to a second native leaflet in response to blood flow through the valve. In this way, valve prolapse can be alleviated and fluid leakage can be minimized.

In some embodiments of the present invention for promoting valve coaptation, the native valve can be a heart valve, such as a mitral valve or an aortic valve. In other embodiments, the native valve can be a venous valve, typically a peripheral venous valve.

Implantation may include implanting the single prosthetic valve leaflet in an open surgical procedure, but more typically will include advancing the single prosthetic valve leaflet intravascularly, transseptally, or transapically, as illustrated in detail below.

When introduced intravascularly, transseptally, or transapically, implantation generally comprises self-expanding an anchor coupled to the single artificial valve leaflet within the native valve annulus. The anchor may expand to completely circumscribe the valve annulus or may expand to partially circumscribe the valve annulus. In both cases, and particularly when the anchor partially circumscribes the annulus, the anchor may include one or more barbs or other tissue penetrating elements that penetrate the native valve annulus upon expansion of the anchor to assist in securing the anchor to the annulus. Alternatively, in some cases, implantation may comprise suturing the anchor coupled to the single artificial valve leaflet to the native valve annulus.

In a third specific aspect of the present invention, a method for delivering an artificial valve coaptation assist device to a native valve site includes providing the artificial valve coaptation assist device, the artificial valve coaptation assist device having an anchor and a single artificial valve assist leaflet constrained within the delivery device. The delivery device is advanced toward the native valve site, and the artificial valve coaptation assist device is deployed from the delivery device at the native valve site. The artificial valve coaptation assist device has an anchor that expands within the annulus of the native valve to position the single artificial valve assist leaflet above the upper surface of the native valve leaflet. The single valve assist leaflet moves in unison with the first native valve leaflet and will coapt to the second native valve leaflet in response to blood flow through the valve. In this way, valve prolapse can be alleviated and leakage can be minimized.

In some embodiments of the method for delivering a prosthetic valve coaptation assist device, the native valve can be a heart valve, such as a mitral valve or an aortic valve. In other embodiments, the native valve can be a venous valve, typically a peripheral venous valve.

Advancing can include advancing the single prosthetic valve leaflet intravascularly, transseptally, or transapically, as illustrated in detail below.

Deployment will typically include releasing the prosthetic valve coaptation assist device from restraint, allowing the anchor to self-expand within the native valve annulus to hold the single prosthetic valve leaflet in place above the first native valve leaflet. The anchor can self-expand to completely circumscribe the valve annulus. Alternatively, the anchor can self-expand to partially circumscribe the valve annulus. In either case, and particularly in the case of partial expansion, the anchor can include one or more barbs that penetrate the native valve annulus when the anchor self-expands.

BRIEF DESCRIPTION OF THE DRAWINGS

The following reference numerals are used in the drawings of this application:

(00) Leaflet assist device (22) Median anchor

(01) Mounting ring (23) Transverse anchor

(02) Device body (24) Delivery catheter for coupling element

(03) Posterior mitral leaflet (25) Steerable delivery device for coupling element

(04) Mitral valve anterior leaflet catheter delivery

(05) Left ventricle (26) Coupler drive element

(06) Left atrium (27) Device with spring element

(07) Device with overlapping leaflets (28) Device with hinges

(08) Chordae tendineae and papillary muscles (29) Coupling position

(09) Atrial septum (30) Peripheral reinforcement

(10) Ventricular septum (31) Flexible reinforcement

(11) Device belt (32) Guide element sheath

(12) Guide catheter with anchoring system (33) Guide element lock

(13) Delivery catheter (34) Screw anchor element

(14) Anchor port (35) Screw anchor drive unit

(15) 4 x (36) Guide element sheath slot apertures for attaching guide catheters (37) Guide element lock feedthrough

(16) Guide catheter for the median anchoring system (38) Anchor drive slot

(17) Anchor nail (39) Helical screw element

(18) Guide catheter for guide nail (40) Locking groove

(19) Guide pin (41) Steering wire

(20) Guide catheter with anchoring system (42) Screw anchoring system

(21) Myocardium

FIG1 illustrates a first embodiment of an artificial leaflet assist device constructed in accordance with the principles of the present invention.

2A and 2B illustrate a prosthetic leaflet assist device implanted in the mitral position of the mitral valve as viewed from the left atrium during mid-diastole (FIG. 2A) and mid-systole (FIG. 2B).

3 illustrates a prosthetic leaflet assist device implanted in a mitral valve as viewed from the left atrium during mid-diastole, viewed from the side.

FIG4 is a photograph of a pair of mitral valve assist device prototypes made of polymer.

5A and 5B are photographs of a reinforced polymer prosthetic leaflet assist device taken from a porcine left atrium during simulated mid-systole ( FIG. 5A ) and mid-diastole ( FIG. 5B ).

FIG. 6A illustrates a band used to secure a leaflet assist device to the mitral valve annulus.

6B illustrates the leaflet assist device of FIG. 6A compressed in a catheter for percutaneous delivery.

7A illustrates a distal portion of a valve assist device configured for delivery within a delivery catheter.

FIG. 7B illustrates the leaflet assist device of FIG. 7A in its deployed configuration.

8 illustrates a device band having a median anchor element and lateral anchor elements on the anchor band.

9, 10A, 10B, and 11 illustrate alternative device strap designs.

12 is a photograph of an alternative mitral valve assist device after deployment in a porcine heart as viewed from the left atrium.

13 is a photograph of yet another alternative mitral valve assist device similar to the mitral valve assist device shown in FIG. 11 in a deployed state.

14-16 depict aspects of yet another alternative leaflet assist device and deployment system including a guide catheter.

17A illustrates a side cross-sectional view of the anchoring portion of a mitral valve assist device after the assist device has been released from a delivery catheter but before activation of the anchor.

FIG. 17B illustrates the device of FIG. 17A after deployment of the anchor.

18 is a cross-sectional view of an anchoring portion useful with the embodiment of FIGS. 14-17A and 17B , shown in a fully deployed configuration.

19A-19D illustrate another alternative mitral valve assist device and delivery system including a delivery catheter visualized at various stages of the delivery cycle.

FIG20 illustrates a mitral valve assist device similar to the device of FIG19, but carried on three coupled delivery catheters.

21A-21D illustrate alternative embodiments of coupling elements terminating in anchoring mechanisms for securing a mitral valve assist device to the myocardium.

FIG. 22 illustrates a device formed from a molded material having a perimeter reinforcement.

23A and 23B show cross sections of a screw anchor system.

23C and 23D illustrate the delivery configuration and the operational configuration of the screw anchor element of FIG. 23A and FIG. 23B , respectively.

FIG. 24 illustrates an embodiment of a steerable delivery catheter for a coupling element.

25 illustrates a steerable delivery catheter delivering a device to a target area via an intravascular transseptal approach from the inferior vena cava.

FIG. 26 illustrates a steerable delivery catheter delivering a device to a target area via an intravascular arterial delivery approach.

FIG. 27 illustrates a steerable delivery catheter delivering a device to a target area via a transseptal approach.

28 illustrates a mitral valve assist device having flexible reinforcements present around the periphery of the mitral valve assist device body to minimize upward displacement of the mitral valve assist device during mitral valve closure.

DETAILED DESCRIPTION

Figure 1 depicts a surgically and/or percutaneously deliverable artificial leaflet assist device 100 having a device ring 101 and a device body or artificial leaflet 102, the device ring 101 acting as an anchor for attachment to tissue at or near the mitral valve or other valve annulus, the device body or artificial leaflet 102 being used to improve the function of the autologous (e.g., mitral valve) leaflet. The leaflet material can be selected from any of the following: a synthetic biocompatible polymer such as Dacron or polyurethane, or a processed natural fixation material such as pericardial material and/or other materials known in the art for implantable valves. The device ring is typically made of metal (e.g., nickel-titanium alloy) or a polymer such as polyurethane. In some embodiments, such as when the leaflet is composed of a natural fixation material, the leaflet is sutured to the ring. When the leaflet is composed of a polymer material, the leaflet can be sutured, molded, or fixed to the device ring using an adhesive. Alternatively, the device ring can be sewn through the leaflet. The flexible leaflet 102 is connected to the autologous leaflet.

Figure 2A depicts the device in the mitral valve position as viewed from the left atrium during mid-diastole. The device ring 201 meets the left side of the annulus fibrosus at the periphery of the anterior mitral leaflet 204, and the left ventricle 205 is visible through the open valve. The device leaflet 202 is located opposite the posterior leaflet 203 and above the anterior mitral leaflet 204. Figure 2B depicts the device during mid-systole.

FIG3 illustrates the device in the mitral valve position during mid-diastole, viewed from the side. The device ring 301 in the left atrium 306 holds the device body or leaflet 302 opposite the posterior mitral leaflet 303 and above the anterior mitral leaflet 304. The leaflet 302 extends into the left ventricle 305 and is captured in the overlap region 307 between the two mitral leaflets. The chordae tendineae and papillary muscles 308 constrain the native leaflets. The atrial septum 309 and ventricular septum 310 are also shown.

FIG4 shows two mock-up variations of a mitral valve assist device made of a polymer. As depicted, the device body 402 is fixed to a polymer ring 401. Alternatively, the device ring 401 and the device body 402 can be molded as a unitary device. As shown, the device body is manufactured in two different sizes to accommodate native mitral valves of varying sizes.

FIG5A shows a top view of a mitral valve assist device comprising a device ring 401 and a device body 402 sutured to the left side of the mitral valve annulus above the mitral valve leaflet 504 of a porcine heart during mid-diastole of the left atrium. The mitral valve assist device is oriented so that the device body is positioned over the anterior mitral valve leaflet opposite the posterior mitral valve leaflet 503. The left ventricle 505 is visible through the open valve. FIG5B shows the same valve during mid-systole.

Figure 6A illustrates a device band 611 that provides an alternative means for securing a leaflet assist device to the mitral valve annulus. This arrangement does not require the valve annulus to be sutured to the annulus, thereby facilitating a simpler percutaneous manner of attaching the leaflet assist device. The device band 611 is comprised of a median or middle anchor 622 and two transverse anchors 623. The anchors are "barb" structures designed to pierce cardiac tissue and lock the device band in place. Figure 6B depicts a leaflet assist device 600 configured for percutaneous delivery and including an anchoring band 611. The device body 602 is wrapped around the device band 611 that has been folded in half at the median anchor 622. The mitral valve assist device is constrained in a delivery catheter 613 and is located at the distal end of the delivery catheter, which can be secured to or detached from the guide catheter 612. When it is secured, a means of detachment is provided, such as by the use of an electrolyzable junction known in the art for releasing arterial stents. The device band is made of nickel-titanium alloy or other material with suitable resilience. During delivery to the atrium, the device 600 is pushed within the delivery catheter 613, accompanied by the guide catheter 612, to force the medial anchor 622 into the mitral annular tissue. The delivery catheter is then moved proximally to release the transverse anchors 623 and the valve body 602. When the transverse anchors unfold after release, they embed themselves in the annular tissue.

FIG7A illustrates the distal portion of a valve assist device 700 configured for delivery within a delivery catheter 713. During delivery, the device band 713 bends at the midpoint between its two prongs that form a median anchor 722. As the device is forced into the myocardium 721 and released from the delivery catheter 713, the median anchor prongs 722 extend, locking the median anchor into the myocardium 721, and the lateral prongs 723 penetrate the myocardium. FIG7B illustrates the leaflet assist device 700 in its deployed configuration.

Figure 8 illustrates a version of a device band in which a median anchoring element 822 and a transverse anchoring element 823 are built into the anchoring band 811. The device band of Figure 8 is short enough that it does not need to be curved to fit the loop.

Figures 9, 10A, 10B and 11 show alternative designs of device bands. Figure 9 includes a device band made of silk thread (such as nickel-titanium alloy or similar materials capable of maintaining high strain). On the anchoring band 911, the median anchoring element 922 is constructed on the spring element 927. When in the delivery configuration, the transverse anchors 923 are pulled together so that they point in a direction away from themselves, and the spring element 927 is compressed, thereby opening the median anchoring element. During delivery, the opened median anchor is pushed against the myocardium, and then the delivery catheter is pulled back to release the transverse anchor 923, which in turn allows the median anchoring element to close, thereby grasping the tissue. When released from the delivery catheter, the transverse anchors 923 are additionally swung into place so that they penetrate into the myocardial tissue.

Figures 10A and 10B depict an alternative device band 1011 in a delivered configuration as shown in Figure 10A and a deliverable configuration as shown in Figure 10B. The device band 1011 includes a hinge element 1028 located at the center of the median anchor element 1022. The hinge element, in some embodiments, includes a locking mechanism so that when converting from the deployable configuration of Figure 10B to the deployed configuration of Figure 10A, the band locks into the deployed configuration when the median anchor is locked into the grasping configuration. In some embodiments, a spring is used to urge the device band into the deployed configuration when the device band is released from the delivery catheter. In other embodiments, the device band 1011 is manipulated and locked into the deployed configuration when released from the delivery catheter.

FIG11 is an image of a prototype of a mitral valve assist device 1100. The device body 1102 is made of Dacron, while the device straps 1111 are made of stainless steel wire. In this image, the intermediate anchor 1122 is bent laterally 90 degrees into its delivery configuration for ease of viewing. As shown, the device straps 1111 are held in place between the Dacron layers via glue. In alternative embodiments, the layers may be stitched, solvent welded, heat welded, ultrasonically welded, or secured in other suitable manners.

In FIG12 , an alternative mitral valve assist device 1200 is shown deployed as viewed from the left atrium. In this embodiment, the device band is similar to the band of FIG11 and is constructed of stainless steel wire. In this configuration, the lateral anchors consist of a pair of anchors at each end of the anchoring band 1211 and a pair of downwardly directed medial anchors 1222, all of which hook into the myocardial tissue 1221. In this embodiment, the device body 1202 is secured to the device band 1211 by wrapping a portion of the device body around the band and locking it in place by suturing. The lateral anchors 1223 have been compressed together to minimize their effect on restricting movement of the affected myocardial tissue.

Another alternative mitral valve assist device similar to the mitral valve assist device shown in Figure 11 is shown in a deployed state in Figure 13. Mitral valve assist device 1300 differs from the device in Figure 12 in that only one median anchor 1322 is present and the lateral anchors 1323 have been extended to improve grip therein in the myocardium.

Figures 14 to 16 depict aspects of yet another alternative leaflet assist device 1400 and deployment system included in a guide catheter 1412. Figure 14 illustrates the mitral valve assist device 1400 in a delivery configuration within a delivery catheter 1413, which is secured to the distal end of a guide catheter 1412 incorporating the delivery system. The valve body 1402 has been pleated to facilitate loading into the delivery catheter 1413. The guide catheter and delivery system 1412 are secured to a mid-section of the device band 1411. In Figure 15, the mitral valve assist device 1400 is depicted during deployment after being released from the delivery catheter 1413. In Figure 15, the device band 1411 is depicted in its unfolded deployment configuration after being released from the delivery catheter, with the valve body 1402 also unfolded. Viewed from the side, the device band remains secured to the guide catheter and delivery system 1412. Figure 16 illustrates the central anchoring portion and anchoring features of the device band 1411. This section of the device band is used to secure the mitral assist device 1400 to the guide catheter during delivery and to anchor the mitral assist device to the myocardium when deployed. The anchoring portion of the device band includes an anchoring port 1414 and a guide catheter attachment feature 1415.

Figure 17A illustrates a side cross-sectional view of the anchoring portion of the mitral valve assist device 1400 deployed after the assist device has been released from the delivery catheter and the device body has been deployed, but before the anchor is activated. The anchoring portion of the assist device consists of the device band 1411 and an activatable anchoring mechanism as described above, which consists of the following features: a guide nail driver 1418, one or more anchor nails 1417, a guide nail 1419, and an anchor nail driver 1416. The cross section shown includes a cross section where the anchor nail passes through the guide. These features are all built into a guide catheter 1420, which is fixed to the device band 1411 at a guide catheter attachment feature 1415. As shown, the guide catheter has been manipulated to direct the mechanism toward the myocardium 1721 at a point at or near the mitral valve annulus. Figure 17B illustrates the device after the anchor is deployed. As depicted in Figure 17, deployment of the anchor after proper alignment is achieved as follows. The anchor guide driver 1418 and the anchor driver 1416 are simultaneously pushed out of the guide catheter 1420 and into the myocardial tissue until the guide pin 1419 rests against the device band 1411. The anchor driver 1416 is then pushed distally, forcing the anchor pin forward through the guide pin 1419 and into the myocardium. As the anchor pin passes through the guide pin, it deforms, locking it into the myocardial tissue.

FIG18 illustrates a cross-section of the anchoring portion in its fully deployed configuration, similar to the embodiment of FIG14 to FIG17A and FIG17B . In this embodiment, only a single driver is required to actuate both the guide pin and the anchor pin. Compared to penetrating the myocardium with the anchor assembly, the mechanism relies on increasing the force required to actuate the anchor pin. During deployment, the anchor assembly, consisting of the guide pin 1819 and the anchor pin 1817, is pushed into the myocardium until it seats against the top surface of the device band 1811. At this point, the anchor pin tines are straight and accommodated within the straight portion of the guide pin. Upon seating and thus penetrating the myocardium, the actuation force is increased, and the anchor pin 1817 is pushed through the guide pin, thereby deforming the distal end of the anchor pin as shown in FIG18 . The cross-section shown in FIG18 is rotated away from the cross-section incorporating the attachment position for the delivery catheter.

Figures 19A to 19D illustrate another alternative mitral assist device and delivery system included in a delivery catheter visualized at various stages of the delivery cycle. Figure 19A illustrates the distal end of the delivery system, wherein the mitral assist device body 1902 is rolled up around a set of delivery coupling elements (not visible) and partially pushed out of the delivery catheter 1913. In Figure 19B, the mitral assist device body 1902 has been fully pushed out of the delivery catheter 1913 and partially unrolled. In Figure 19C, the mitral assist device 1900 is shown fully unrolled and tied to the coupling elements 1924. The mitral assist device 1900 is now oriented 90 degrees toward the delivery catheter, and the delivery coupling elements 1924 are visible. In Figure 19D, the mitral assist device 1900 has been rotated 90 degrees by withdrawing the delivery catheter relative to the mitral assist device or pushing the coupling elements further out of the delivery catheter, and then equalizing the length of the coupling elements delivered from the delivery catheter. In this manner, the orientation of the mitral assist device can be adjusted through a range of angles to better facilitate alignment with the mitral annulus before securing the device in place.

20 illustrates a mitral valve assist device similar to that of FIG. 19 but carried on three coupled delivery catheters 2024; the device is then secured in place via anchoring elements at anchor locations 2029 using an anchor installation tool (not shown).

The devices of Figures 19 and 20 can be secured in place in a number of different ways. These ways include, but are not limited to, any of the following. The device can be appropriately placed within the mitral valve, followed by placement of a mitral annuloplasty band (not shown). The annuloplasty band is then secured in place, thereby locking the mitral assist device between the annuloplasty band and the mitral valve wall. One such band that can be used in this manner is the Valtech Cardioband. Alternatively, an anchoring element can be delivered via a second delivery catheter and used to anchor the attachment edge of the mitral assist device to the myocardium. The anchoring element can be, but is not limited to, any of the following configurations: a helical anchor as described in US6478776 to Rosenman, but including a cap; a helical anchor as described in US7988725 to Gross; an expandable staple anchor as described herein; a staple anchor as described in US6986775 to Morales.

In an alternative embodiment, the coupling elements can terminate in anchoring mechanisms that are in turn used to secure the mitral assist device to the myocardium. Figure 21 illustrates such a device. Figure 21C illustrates after the mitral assist device 2100 has been delivered from within the delivery catheter 2113, the device body has been deployed, and the steerable coupling elements 2130 have been manipulated into a plane parallel to the longitudinal axis of the delivery catheter. During deployment, the device coupling positions will be aligned with or near the mitral annulus and will be steered so that they face the myocardium. In such a configuration, the terminal anchoring mechanisms can include any of the anchoring means previously described herein.

When the device body is constructed of a molded material as shown in Figure 22, a peripheral reinforcement 2230 can be molded into the device body 2202. In addition to the peripheral reinforcement 2230, a flexible reinforcement 2231 can also be incorporated into the device body. Alternatively, the flexible reinforcement can be constructed along a longitudinal cross-section of the device body. Such a reinforcement will, in some embodiments, be sandwiched between the proximal surface layer and the distal surface layer of the device body. The mitral valve assist device 2200 includes a device body 2202 and a device band 2211, with an anchoring element 2238 deployed by an anchoring drive 2225. After the helical anchoring screw 2239 is secured into the myocardial tissue, the guide sheath 2232 and the guide lock 2233 are removed, thereby allowing the anchoring element drive 2225 to be retracted.

23A and 23B illustrate a cross-section of a screw anchor system 2342 comprising a screw anchor element 2334, screw anchor guide elements 2333 and 2332, and a screw anchor driver 2335. FIG23A shows the screw anchor driver 2335 positioned at, but not engaged with, the anchor drive slot 2338, while FIG23B shows the driver element engaged with the drive slot. A guide system consisting of a guide element lock 2333 and a guide element sheath 2332 facilitates alignment and engagement of the driver element with the drive slot. These guide elements extend through the screw drive anchor 2335 along a lumen that spans the length of the driver element and are removed from the assembly after deployment of the anchor element by removing the guide lock 2333, which in turn releases the guide sheath 2332, thereby allowing the guide element and driver element to be removed from the anchor element. 23C and 23D illustrate the delivery and operational configurations, respectively, of the screw anchor element 2334, wherein the helical screw element 2339 is deployed using the screw anchor drive 2335 as described above in FIG. 23A and FIG. 23B.

Figure 24 shows one embodiment of a steerable delivery catheter for a coupling element. Steering is achieved by pulling on a steering wire 2441 causing the catheter 2425 to bend. Alternative catheter steering systems known in the art may also be employed.

Figures 25 to 27 depict the use of three different approaches to deliver a leaflet assist device as described herein. Figure 25 shows a steerable delivery catheter delivering the device to the target area from the inferior vena cava via an intravascular transseptal approach. As shown, the distal end of the delivery catheter 2513 has passed through the septum between the right atrium and the left atrium. Thereafter, the mitral valve assist device is delivered from the delivery catheter and then oriented so that the mitral valve assist device body is positioned above the posterior mitral valve leaflet 2503 and between the anterior and posterior mitral valve leaflets. The device band 2511 is aligned with the left side of the annulus fibrosus at the periphery of the posterior mitral valve leaflet 2504. A screw anchoring system 2542 is then used to secure the mitral valve assist device in place. As depicted in Figure 25, the delivery catheter 2513 is a steerable catheter known in the art. Figure 26 depicts an intravascular arterial delivery approach, while Figure 27 depicts a transapical approach.

Figure 28 illustrates a mitral valve assist device in which flexible reinforcement elements 2831 have been built into the periphery of the mitral valve assist device body 2802 to minimize upward displacement of the mitral valve assist device during mitral valve closure. The device body 2802 is constructed of fabric, polymer sheet, or tissue, and the reinforcement mechanism can be sewn into place as shown. In some cases, a biasing material can be used to cover the reinforcement element. The reinforcement element can be constructed of a polymer material, a superelastic material, or a combination of such materials.

Claims (9)

1. An artificial valve connection assist device, comprising: Single valve-assisted leaflet; and An anchor, configured to attach to and fully externalize an autologous valve ring, wherein the anchor is a ring; The individual valve assist leaflet is configured to rest against the upper surface of the first autologous valve leaflet when the anchor is attached to the autologous valve annulus. The individual valve assist leaflet has a fixed end and a movable end, the fixed end being coupled to a first side of the anchor, and the movable end opposite the fixed end. The periphery of the individual valve assist leaflet includes flexible reinforcement elements to minimize upward displacement of the valve engagement aid during valve closure. When the anchor is attached to the autologous valve ring, an open space is formed between the movable end of the individual valve accessory leaflet and the second side of the anchor opposite to the first side. This open space accommodates the movement of the second autologous valve leaflet in response to blood flow through the valve. The individual valve accessory leaflet is sufficiently flexible and the movable end of the individual valve accessory leaflet is freely movable, such that the individual valve accessory leaflet moves in unison with the first autologous valve leaflet and engages with the second autologous valve leaflet in response to blood flow through the valve. 2. The artificial valve engagement aid as claimed in claim 1, wherein the anchor is configured to self-expand to attach to the autologous valve annulus. 3. The artificial valve fitting aid as claimed in claim 1, wherein the anchor is configured for suturing to the autologous valve annulus. 4. The artificial valve fitting assist device of claim 1, wherein the anchor is configured to be attached to the mitral valve or the aortic valve. 5. The artificial valve fitting assist device as claimed in claim 1, wherein the artificial valve fitting assist device is configured to be advanced into the blood vessel. 6. The artificial valve engagement aid as claimed in claim 1, wherein the anchor includes one or more barbs that penetrate the autologous valve annulus when the anchor expands. 7. The artificial valve fitting assist device of claim 1, wherein the individual valve assist leaflet comprises a body formed of tissue or synthetic polymer and further comprises a reinforcing structure. 8. The artificial valve fitting assist device as claimed in claim 7, wherein the reinforcing structure comprises a metal reinforcing structure. 9. The artificial valve fitting assist device of claim 1, wherein the movable end of the single valve assist leaflet is the ventricular end.