Devices, systems, and methods for transcatheter treatment of valve regurgitation

Abstract

The present invention relates to devices for transcatheter treatment of mitral regurgitation, in particular to coaptation-assist devices for implantation across a valve; systems comprising a coaptation-assist device and an anchor for implantation; systems comprising a coaptation-assist device and a delivery catheter; and methods for transcatheter implantation of a coaptation device across a heart valve.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201680077877.8, filed on November 2, 2016, entitled "Apparatus, System and Method for Transcatheter Treatment of Valve Regurgitation".

[0002] Cross-references to related applications

[0003] This application claims priority under 35 USC § 120 as a continuation application of U.S. Application No. 15 / 153480, filed May 12, 2016, and further claims priority under 35 USC § 119(e) as a non-provisional application of U.S. Provisional Application No. 62 / 252336, filed November 6, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety and forms part of this specification. Technical Field

[0004] This disclosure generally provides improved medical devices, systems, and methods typically used for treating valvular heart disease and / or for altering the characteristics of one or more valves in the body. Embodiments include implants for treating mitral regurgitation.

[0005] The human heart receives blood from organs and tissues via veins, pumps this blood through the lungs, where it becomes oxygen-rich and propels the oxygenated blood out of the heart into the arteries so that the body's organ systems can extract oxygen for their proper functions. The deoxygenated blood flows back to the heart, where it is pumped back to the lungs.

[0006] The heart consists of four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA), and the left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously throughout the total cardiac cycle.

[0007] The heart has four valves, which are normally configured to selectively pump blood in the correct direction during the cardiac cycle. The valve that separates the atria from the ventricles is called the atrial-ventricular (AV) valve. The AV valve between the left atrium and left ventricle is the mitral valve. The AV valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

[0008] The mechanical heartbeat is triggered by electrical impulses propagating throughout the heart tissue. The opening and closing of heart valves can occur primarily due to pressure gradients between chambers, generated by passive filling or chamber contraction. For example, the opening and closing of the mitral valve can occur due to the pressure gradient between the left atrium and left ventricle.

[0009] At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Immediately thereafter, the AV valves open to allow unimpeded flow from the atria into the corresponding ventricles. Immediately after the onset of ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the corresponding atria.

[0010] Unfortunately, AV valves can be damaged or may not function properly, leading to abnormal closure. AV valves are complex structures, typically consisting of an annulus, leaflets, chordae, and supporting structures. Each atrium is connected to its valve via the atrial vestibule. The mitral valve has two leaflets; the tricuspid valve has a similar structure with three leaflets, and the juxtaposition or engagement of the corresponding surfaces of the leaflets facing each other helps provide closure or sealing of the valve, preventing blood from flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is called malcoaptation and may allow blood to flow back through the valve (regurgitation). Venous regurgitation can have serious consequences for patients, typically leading to heart failure, reduced blood flow, low blood pressure, and / or reduced oxygen delivery to body tissues. Mitral regurgitation can also cause blood to flow back from the left atrium into the pulmonary veins, causing congestion. Severe valvular regurgitation, if left untreated, can lead to permanent disability or death. Background Technology

[0011] Several therapies have been applied to treat mitral regurgitation, and others are still being proposed but not yet used to treat patients. While several known therapies have been found to benefit at least some patients, further options remain. For example, medications such as diuretics and vasodilators can be used in patients with mild mitral regurgitation to help reduce the amount of blood returning to the left atrium. However, drug therapy may lack patient adherence. Many patients may occasionally (or even regularly) fail to adhere to medication, despite the potential severity of chronic and / or worsening mitral regurgitation. Pharmacological treatment of mitral regurgitation can also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with serious side effects such as hypotension.

[0012] Various surgical options have been proposed and / or used to treat mitral regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In annuloplasty repair, the posterior mitral annulus can be reduced in size along its circumference, optionally using sutures that pass through the mechanical annuloplasty suture ring to provide coaptation. Open surgery may also attempt to reshape the leaflets and / or remodel the supporting structures. In any case, open mitral valve surgery is generally a very invasive procedure performed on a cardiopulmonary bypass machine while the patient is under general anesthesia and the thoracotomy is performed. Complications can be common, and given the morbidity (and potential mortality) of open-heart surgery, scheduling becomes challenging—more severely ill patients may desperately need surgery but are less able to tolerate it. Successful open mitral valve surgery can also be highly dependent on surgical skill and experience.

[0013] Given the morbidity and mortality rates of open-heart surgery, innovators have explored less invasive surgical approaches. Methods utilizing robots or endoscopic techniques are generally still quite invasive and can be time-consuming, expensive, and, at least in some cases, highly dependent on the surgeon's skill. It would be ideal to provide even less trauma to these sometimes frail patients, and equally ideal would be to offer a therapy that can be successfully performed by a large number of physicians using varying techniques. To this end, several techniques and methods that are claimed to be less invasive have been proposed. These include devices that attempt to reshape the mitral valve annulus from within the coronary sinus; devices that attempt to reshape the valve annulus by tightening the natural annulus from top to bottom; devices for fusing valve leaflets (mimicking the Alfieri suture); devices for reshaping the left ventricle, etc.

[0014] A variety of mitral valve replacement implants have been developed, perhaps the most well-known, which typically replace (or substitute) the natural valve leaflets and rely on the surgically implanted structure to control the flow of blood between the heart chambers. While these diverse methods and tools meet varying levels of approval, none is yet widely recognized as the ideal treatment for most or all patients suffering from mitral regurgitation.

[0015] Due to the known challenges and drawbacks of minimally invasive mitral regurgitation therapies and implants, alternative treatments are still being proposed. Some of these proposals require the implanted structure to remain within the valve annulus throughout the entire cardiac cycle. One group of these proposals includes structures such as cylindrical balloons that are held in place by a cord or rigid bar extending between the atrium and ventricle through the valve opening. Another group relies on structures such as arcuate rings, often combined with an arched wall or structural transverse member extending through the valve to anchor the implant. Unfortunately, sealing between the natural leaflet and the entire periphery of the balloon or other coaxial structure can prove challenging, and significant contraction around the natural valve annulus during each cardiac stroke can lead to significant fatigue failure of the tissue over long-term implantation if the arched wall or the transverse member of the retainer is bent. Furthermore, significant movement of the valve tissue can make accurate implant placement difficult, regardless of whether the implant is rigid or flexible.

[0016] In light of the above, it is ideal to provide improved medical devices, systems, and methods. Particularly desirable are new technologies for treating mitral regurgitation and other valvular heart diseases, and / or for altering the characteristics of one or more of the body's other valves. There remains a need for devices that can directly enhance leaflet occlusion (rather than indirectly via annular or ventricular remodeling) and without disrupting leaflet anatomy through fusion or other means, yet can be deployed simply and reliably without excessive cost or operative time. It will be particularly advantageous if these new technologies can be implemented using less invasive methods, without requiring cardiac arrest or reliance on a cardiopulmonary bypass machine for deployment, and without depending on the surgeon's exceptional skill, thereby providing improved valvular and / or cardiac function. Summary of the Invention

[0017] This disclosure generally provides improved medical devices, systems, and methods. Novel occlusion assist devices, systems, and methods for treating mitral regurgitation and other valvular disorders are disclosed. The occlusion assist device can be held within the blood flow path as the valve moves back and forth between an open valve configuration and a closed valve configuration. The occlusion assist device can be a thin, elongated (along the blood flow path), and / or conforming structure that extends laterally through some, most, or all of the valve opening width, allowing occlusion between at least one of the natural leaflets and the occlusion assist device. The devices described herein can be used with any valve in the human body, including valves with two or three leaflets.

[0018] In some embodiments, an advantage is the ability to retrieve the occlusion assist device. In some embodiments, the occlusion assist device has a single anchor that can engage or disengage from tissue. In some embodiments, the anchor is captured within an annular bushing of the occlusion assist device. In some embodiments, the captured anchor is removed simultaneously with the removal of the occlusion assist device. In some embodiments, the occlusion assist device may include secondary anchors. In some embodiments, the occlusion assist device may include passive anchors. In some embodiments, engagement of the anchor with tissue arranges one or more passive anchors to engage with the tissue. In some embodiments, an advantage is the ability to retrieve the occlusion assist device during the procedure. In some embodiments, the occlusion assist device can be rearranged during the surgical procedure. In some embodiments, the occlusion assist device can be removed from the patient during a subsequent surgical procedure. In some embodiments, the occlusion assist device can be replaced by another device during a subsequent surgical procedure. In some embodiments, a single annular anchor facilitates the ability to retrieve the occlusion assist device. In some embodiments, the location of the annular anchor facilitates the ability to retrieve the occlusion assist device. In some implementations, as described herein, the ability to fold the purse-string suitcase using the purse opening drawstring folding aid facilitates the retraction of the purse-string suitcase.

[0019] In some embodiments, an advantage is the connection between the occlusion aid and the delivery catheter. In some embodiments, the occlusion aid includes an annular bushing with features for engaging the delivery catheter. In some embodiments, the occlusion aid and the delivery catheter are removably coupled so that the occlusion aid can be released from the delivery catheter during the procedure. In some embodiments, after the occlusion aid is released from the delivery catheter, one or more secondary structures couple the occlusion aid and the delivery catheter. In some embodiments, one or more secondary structures include a drawstring suture as described herein. In some embodiments, one or more secondary structures facilitate folding and / or unfolding of the occlusion aid. In some embodiments, the occlusion aid and the delivery catheter are rotated and fixed relative to each other during coupling. In some embodiments, relative movement of the delivery catheter causes movement of the occlusion aid.

[0020] In some implementations, an advantage is that the occlusion assist device can be delivered using a bushing-guided orientation. In some methods of use, the annular bushing can be moved into position relative to the anatomical structure. In some methods of use, the ventricular end of the occlusion assist device can be held within the delivery catheter until the annular bushing is positioned. In some methods of use, the occlusion assist device can be deployed once the annular bushing and / or the valve annulus anchor has engaged with the tissue. In some methods of use, the ventricular end of the occlusion assist device can be positioned once the annular bushing and / or the valve annulus anchor has engaged with the tissue.

[0021] In some implementations, an advantage is that the occlusion aid can be delivered using a strut-guided orientation. In this method of use, one or more struts of the occlusion aid can be moved into position relative to the anatomy prior to the placement of the annular liner. In some methods of use, the occlusion aid can be deployed or partially deployed prior to engagement of the valve annulus anchor. In some methods of use, the annulus liner can be retained within the delivery catheter until one or more struts have been placed. In some methods of use, once the struts have been placed, the valve annulus anchor can engage with the tissue.

[0022] In some implementations, an advantage is that the annular anchor can rotate independently of the occlusion aid. As described herein, the occlusion aid is coupled to a portion of the delivery catheter. As described herein, the annular anchor is independently coupled to another portion of the delivery catheter, such as a actuator disposed with the delivery catheter. The annular anchor can rotate independently of the annular bushing. When the annular anchor is rotated to engage the tissue, the annular bushing can remain fixed. The annular anchor can be driven into the tissue while the delivery catheter maintains the position of the annular bushing.

[0023] In some embodiments, an advantage is the ability to fold the occlusion assist device. In some embodiments, the occlusion assist device is fully folded. A fully folded configuration can be an insertion configuration or a low-profile configuration. In some embodiments, the occlusion assist device is partially folded. A partially folded configuration can be a partially deployed configuration. A partially folded configuration allows for selective deployment of the occlusion assist device within the heart. A partially folded configuration allows for movement of the occlusion assist device to a position within the heart. The configuration of the occlusion assist device can be monitored, for example, by imaging to ensure proper deployment. In some embodiments, one or more suturing loop sutures or portions thereof are tightened to fold or partially fold the occlusion assist device. In some embodiments, a partially folded configuration can allow rotation of the occlusion assist device. In some embodiments, a fully folded configuration can allow rotation of the occlusion assist device. In some embodiments, the occlusion assist device can rotate together with a delivery catheter or a portion thereof. In some embodiments, the occlusion assist device can rotate about a central location, such as an annular bushing.

[0024] In some embodiments, an advantage is the ability to deploy the occlusal assist device. In some embodiments, one or more pocket-mouth pull-tab sutures or portions thereof are loosened to deploy the occlusal assist device. In some embodiments, loosening the pocket-mouth pull-tab sutures causes one or more struts to assume an intermediate configuration. In some embodiments, loosening the pocket-mouth pull-tab sutures causes one or more struts to assume a pre-shaped curve. In some embodiments, one or more struts comprise NiTi. In some embodiments, the pocket-mouth pull-tab sutures can be repeatedly tightened and / or loosened. In some embodiments, the pocket-mouth pull-tab sutures are trapped within the occlusal assist device. In some embodiments, the pocket-mouth pull-tab sutures are tightened to remove the occlusal assist device from the patient. In some embodiments, the pocket-mouth pull-tab sutures are loosened to deploy the occlusal assist device within the patient's heart. In some embodiments, the pocket-mouth pull-tab sutures can be selectively deployed to deploy a portion of the occlusal assist device while another portion of the occlusal assist device remains folded or partially folded.

[0025] In some embodiments, an advantage is the ability to adjust the mating aid. In some embodiments, the mating aid may be supported by a central location. In some embodiments, the central location is an anchor. In some embodiments, the central location is a bushing. In some embodiments, the bushing and / or anchor is typically located near the midpoint of the diameter of the mating aid. In some embodiments, the bushing and / or anchor is typically located near the midpoint and / or central location of the annular portion of the mating aid. In some embodiments, the mating aid may be supported in an intermediate location. In some embodiments, the mating aid can be rotated by rotating a delivery conduit connected to the annular bushing. In some embodiments, the mating aid can be moved longitudinally by a corresponding longitudinal movement of the delivery conduit connected to the annular bushing.

[0026] In some embodiments, an advantage is that the occlusal assist device can be retained via the delivery catheter after deployment. In some embodiments, the occlusal assist device can be fully deployed within the mitral valve but remains tethered to the delivery catheter. In some embodiments, the occlusal assist device can be adjusted after full deployment within the mitral valve. In some embodiments, the occlusal assist device can be rotated around the liner after full deployment. In some embodiments, the anchor can be detached from and / or re-engaged with the tissue after full deployment. In some embodiments, the pocket-mouth drawstring suture can be folded and / or unfolded after full deployment. In some embodiments, the occlusal assist device can be recaptured after full deployment. In some embodiments, the occlusal assist device can be removed after full deployment.

[0027] In some implementations, an advantage is that the occlusive support device does not require ventricular attachment. In some implementations, the occlusive support device requires only annular attachment. In some implementations, the occlusive support device requires only annular anchors attached via annular bushings. In some implementations, the occlusive support device requires only annular anchors attached via annular bushings and annular barbs. In some implementations, the occlusive support device requires only annular anchors attached via annular bushings, annular barbs, and / or commissural barbs.

[0028] In some embodiments, an advantage is a radially extending frame. In some embodiments, the frame includes an annular bushing and one or more struts. In some embodiments, the struts extend radially from the annular bushing. In some embodiments, the frame is constructed from a single planar sheet of material. In some embodiments, the frame is precisely cut using waterjet, laser etching, or similar techniques. In some embodiments, the frame is constructed by forming an annular bushing with the edges of the frame. In some embodiments, the planar sheet of material is formed into a ring, which becomes the annular bushing. In some embodiments, the struts are bent into a desired configuration. In some embodiments, the struts are uniformly spaced around the circumference of the annular bushing. In some embodiments, the struts are non-uniformly spaced around the circumference of the annular bushing. In some embodiments, struts extending along a portion of the circumference of the annular bushing differ from struts extending along another portion of the circumference of the annular bushing. In some embodiments, one or more designated portions of the struts are designed to be placed near the annular region of the heart. In some embodiments, one or more designated portions of the struts are designed to be placed near the commissural region of the heart. In some embodiments, one or more designated portions of the struts are designed to be placed near the ventricular region of the heart. In some embodiments, the radially outward frame supports do not intersect. In some embodiments, the radially outward frame supports do not form a mesh. In some embodiments, the radially outward frame supports extend along a line from the bushing to the edge of the mating aid. In some embodiments, the radially outward frame supports have sharp edges. In some embodiments, the sharp edges extend along a straight line originating from the edge of the mating aid. In some embodiments, the sharp edges are integrally formed within the supports. In some embodiments, the radially outward frame supports have one, two, or more radii of curvature. In some embodiments, the radially outward frame supports may be concave, convex, or both along their length. In some embodiments, the radially outward frame supports have one or more inflection points.

[0029] In some embodiments, an advantage is the bending of the frame. In some embodiments, the annular bushing extends radially. In some embodiments, the annular bushing extends from the copulatory aid away from the valve annulus. In some embodiments, the annular bushing extends from the surface of the copulatory aid above the plane of the strut. In some embodiments, the edges of the copulatory aid are curved. In some embodiments, one or more struts can bend laterally from the annular bushing toward the upper edge. In some embodiments, the upper edge of the copulatory aid can bend upward from the valve annulus. In some embodiments, the upper edge of the copulatory aid can bend upward from the posterior leaflet. In some embodiments, the upper edge of the copulatory aid can bend downward toward the valve annulus. In some embodiments, the upper edge of the copulatory aid can bend downward toward the posterior leaflet. In some embodiments, one or more struts can bend laterally from the annular bushing toward the lower edge. In some embodiments, the lower edge of the copulatory aid can bend away from the posterior leaflet. In some embodiments, the lower edge of the copulatory aid can bend toward the posterior leaflet.

[0030] In some embodiments, an occlusion assist device is provided for treating malalignment of heart valves. The heart valve has an annulus. The occlusion assist device may include a body comprising an annular portion and an occlusion portion. In some embodiments, the annular portion is configured to be implanted within the heart above the annulus. In some embodiments, the occlusion portion is configured to be implanted within the heart and transverse to the plane of the annulus. The occlusion assist device may include a first occlusion surface and an opposite second occlusion surface. In some embodiments, each surface is limited by a first lateral edge, a second lateral edge, a lower edge, and an upper edge. In some embodiments, the upper edge forms a lip and is cupped downward toward the lower edge or upward from the annular portion. The occlusion assist device may include a bushing and an anchor coupled to this bushing and supported by the annular portion. In some embodiments, the anchor may be selectively deployed at a first target location. The occlusion assist device may include a plurality of struts extending radially outward from the bushing. In some embodiments, the plurality of supports includes at least a first support located within the annular portion and a second support extending from the annular portion to the mating portion, wherein the second support has a total length longer than the total length of the first support, such as, for example, about or at least about 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250% or more of the total length of the first support. In some embodiments, the total length of the second support is about 125% to about 300%, or about 125% to 200% of the total length of the first support.

[0031] In some embodiments, at least one of the plurality of struts has a sharp tip configured to engage tissue. In some embodiments, the plurality of struts comprises nitinol. In some embodiments, the anchor is helical. The engagement aid may include one or more additional anchors. In some embodiments, the one or more additional anchors are active anchors. In some embodiments, the bushing includes a pin configured to extend through a helical structure of the anchor. In some embodiments, the bushing is configured to mate with a delivery conduit configured to position the bushing near the first target location. In some embodiments, the delivery conduit is configured to allow the anchor to rotate independently of the bushing. The engagement aid may include radiopaque markers. The engagement aid may include a plurality of radiopaque markers near the upper edge. In some embodiments, the upper edge forming the flange is cupped downward toward the lower edge. In some embodiments, the upper edge forming the flange is cupped upward from the annular portion. In some embodiments, the bushing extends upward from the annular portion. In some embodiments, the lower edge bends backward toward the bushing.

[0032] In some embodiments, a method is provided for treating malalignment of a patient's heart valves. The heart valve has a valve annulus. The valve annulus also defines a valve plane that separates the proximal atrium and the distal ventricle. The method includes the step of coupling a delivery catheter to a bushing of an occlusion assist device. The method may include the step of positioning the bushing near the valve annulus. The method may include the step of rotating an anchor through the bushing and into cardiac tissue distal to the valve annulus. The method may include the step of deploying the occlusion assist device by radially outwardly deploying a plurality of struts from the bushing.

[0033] In some embodiments, the occlusion aid is suspended such that the occlusion surface occludes with the first leaflet, and the leaflet surface of the occlusion aid covers the second leaflet to mitigate malalignment. The method may include the step of engaging the sharp tip of one of the plurality of struts with cardiac tissue distal to the valve annulus. The method may include the step of monitoring the position of the occlusion aid using one or more markers. The method may include the step of monitoring the position of the occlusion aid using a plurality of markers near the upper edge of the occlusion aid. In some embodiments, the tip of the anchor is recessed into the bushing during bushing placement near the valve annulus. Attached Figure Description

[0034] Figure 1A-1F The diagram schematically illustrates some tissues of the heart and mitral valve, as described in the background section and below, and how they can interact with the implants and systems described herein.

[0035] Figure 2AThe illustration shows a simplified cross-section of the heart, schematically illustrating mitral valve function during diastole.

[0036] Figure 2B The illustration shows a simplified cross-section of the heart, schematically illustrating mitral valve function during cardiac systole.

[0037] Figures 3A-3B The illustration shows a simplified cross-section of the heart, schematically illustrating mitral regurgitation during cardiac systole in the case of mitral valve leaflet malalignment.

[0038] Figure 4A The illustration shows a stylized cross-section of the heart, illustrating mitral valve malocclusion in the case of functional mitral regurgitation.

[0039] Figure 4B The illustration shows a stylized cross-section of the heart, demonstrating mitral valve malocclusion in the case of degenerative mitral regurgitation.

[0040] Figure 5A The illustration shows a perspective view of one embodiment of the coupling auxiliary device.

[0041] Figure 5B The diagram shows Figure 5A A top view of the mating auxiliary device.

[0042] Figures 5C-5D The illustration shows one embodiment of the support column of the coupling auxiliary device.

[0043] Figure 5E-5G The diagram illustrates the section without the annular anchorage. Figure 5A The matching auxiliary device.

[0044] Figure 5H-5J The diagram illustrates a part with a leaflet anchoring structure. Figure 5A The matching auxiliary device.

[0045] Figure 5K The diagram shows Figure 5A The dimensions of the mating auxiliary device.

[0046] Figure 6 The illustration shows a perspective view of one embodiment of the coupling auxiliary device.

[0047] Figure 7A The illustration shows a perspective view of one embodiment of the apposition assist device, showing a first surface facing the natural leaflets of poorly appositioned apposition.

[0048] Figure 7B The diagram shows Figure 7A Another perspective view of the mating auxiliary device shows a second surface that may include the mating surface.

[0049] Figure 7C The diagram shows Figure 7A A top view of the mating auxiliary device.

[0050] Figure 7D The illustration shows a model implanted in the mitral valve. Figure 7A The matching auxiliary device.

[0051] Figure 7E The illustration shows a model implanted in the mitral valve. Figure 7A A top view of the mating auxiliary device.

[0052] Figure 8A An embodiment of a control handle for a transcatheter delivery system is illustrated schematically.

[0053] Figure 8B The illustration shows the relationship with Figure 8A Top and side views of the coupling auxiliary device coupled to the delivery system.

[0054] Figure 8C The connection between the annular bushing of the engagement aid and the tip of the delivery catheter is schematically illustrated.

[0055] Figure 9A schematically illustrated Figure 8A The anchoring operation of the delivery system.

[0056] Figure 9B-9E The connection between the valve ring anchor and the actuator is schematically illustrated.

[0057] Figure 10 The illustration schematically depicts a method for transcatheter techniques, showing transatrial septal crossing.

[0058] Figure 11 The illustration schematically depicts a method step for transcatheter technology, showing the advancement of the initial engagement aid.

[0059] Figure 12 The illustration schematically depicts a method for transcatheter techniques, showing the activation of a partial engagement aid.

[0060] Figure 13 The illustration schematically depicts a method step for transcatheter technology, showing the folding of the apposition assist device.

[0061] Figure 14 The illustration schematically depicts a method for transcatheter technology, showing a cross-sectional view of the mate-aid device.

[0062] Figure 15 The illustration schematically depicts a method for transconductor technology, showing the placement of secondary anchors. Detailed Implementation

[0063] This invention provides, in some embodiments, generally improved medical devices, systems, and methods commonly used to treat mitral regurgitation and other valvular diseases, including tricuspid regurgitation. Although the following description includes references to the anterior leaflet of a valve with two leaflets, such as the mitral valve, it should be understood that “anterior leaflet” can refer to one or more leaflets of a valve with multiple leaflets. For example, the tricuspid valve has three leaflets, so “anterior” can refer to one or both of the medial, lateral, and posterior leaflets. The occlusal assist devices described herein will generally include an occlusal assist body (sometimes referred to herein as the valve body), which typically follows the blood flow path as the valve leaflets move back and forth between an open valve configuration (where the anterior leaflet is separated from the valve body) and a closed valve configuration (where the anterior leaflet engages with the opposing valve body surface). The valve body is positioned between the natural leaflets to close gaps caused by malalignment of the natural leaflets by providing an occlusal surface for at least one of the natural leaflets while effectively replacing a second natural leaflet in the valve region that would normally close during systole. The gap can be transverse (e.g., caused by a dilated left ventricle and / or mitral annulus) and / or axial (e.g., when a leaflet prolapses or is pushed out of the annulus by fluid pressure when the valve should close). In some embodiments, the occlusal assist device can fully assist one, two, or more leaflets, or in some embodiments, partially assist the leaflets, for example, by covering only one or more of the A1, A2, and / or A3 sectors of the anterior leaflet, and / or one or more of the P1, P2, and / or P3 sectors of the posterior leaflet.

[0064] In other applications, the occlusive aids and methods described herein can be configured to treat functional and / or degenerative mitral regurgitation (MR) by forming an artificial or novel occlusive zone that can be sealed within at least one of the natural mitral leaflets. The structures and methods described herein will be largely suited for this application, although alternative embodiments may be configured for other valves of the heart and / or body, including the tricuspid valve, valves of the peripheral vascular system, the inferior vena cava, etc.

[0065] See Figure 1A-1D The image shows the four chambers of the heart: left atrium 10, right atrium 20, left ventricle 30, and right ventricle 40. The mitral valve 60 is positioned between the left atrium 10 and left ventricle 30. The tricuspid valve 50 (which separates the right atrium 20 and right ventricle 40), aortic valve 80, and pulmonary valve 70 are also shown. The mitral valve 60 consists of two leaflets (anterior leaflet 12 and posterior leaflet 14). In a healthy heart, the two leaflets are juxtaposed at the occlusal zone 16 during systole.

[0066] The fibrous valve annulus 120, as part of the cardiac frame, provides attachment to the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14. The leaflets are axially supported by attachment to chordae tendineae 32. These chordae tendineae are in turn attached to one or both of the papillary muscles 34 and 36 of the left ventricle. In a healthy heart, these chordae tendineae support structures tether the mitral valve leaflets, allowing them to open easily during diastole but to withstand the high pressure that develops during ventricular systole. In addition to the tethering effect of the support structures, the shape and tissue consistency of the leaflets contribute to effective sealing or occlusion. The leading edges of the anterior and posterior leaflets meet along a funnel-shaped occlusion zone 16, the cross-section 160 of which of the three-dimensional occlusion zone (CZ) is schematically shown. Figure 1E middle.

[0067] The anterior and posterior mitral valve leaflets have different shapes. The anterior leaflet is more firmly attached to the annulus covering the central fibrous body (cardiac strut) and is slightly stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80% of the closure area is the anterior leaflet. Adjacent to commissures 110 and 114, the left (lateral) 124 and right (septal) 126 fibrous triangular ridges, formed when the mitral annulus fuses with the base of the non-coronary cusp of the aorta, are located above or anterior to annulus 120. Figure 1F Fiber triangular prisms 124, 126 form the septal and lateral extensions of the central fibrous body 128. In some embodiments, fiber triangular prisms 124, 126 may have advantages such as providing a robust region for stable engagement with one or more valve annular archors or atrial archors. The occlusion zone CL between leaflets 12, 14 is not a simple line, but a curved, funnel-shaped surface interface. The first 110 (lateral or left-side) and second 114 (septal or right-side) commissure is where the anterior leaflet 12 and the posterior leaflet 14 meet at the valve annulus 120. Figure 1C , 1D Most clearly visible in the axial view of the atrium at 1F, the axial cross-section of the occlusal region typically shows a curved line CL, which is separated from the centroid of the valve annulus CA and from the opening through the valve during diastolic CO. Furthermore, the leaflet edges are serrated, especially the posterior leaflet compared to the anterior leaflet. Malalignment can occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, causing the characteristics of malalignment to vary along the curve of the occlusal region CL.

[0068] Now see Figure 2A In proper cardiac function, the mitral valve 60 is open during diastole to allow blood to flow along the path FP from the left atrium to the left ventricle 30 and thereby fill the left ventricle. (As in...) Figure 2BAs shown, by increasing ventricular pressure, the mitral valve 60, which functions, closes during systole and effectively separates the left ventricle 30 and the left atrium 10, first passively and then actively, thereby allowing the cardiac tissue surrounding the left ventricle to contract and thus propel blood through the vascular system.

[0069] See Figures 3A-3B In cases 4A-4B, several conditions or disease states exist in which the mitral valve leaflets do not align properly, thus allowing blood to flow back from the ventricle to the atrium during systole. Regardless of the specific cause in a particular patient, the inability of the leaflets to seal during ventricular systole is called malalignment and causes mitral regurgitation.

[0070] Typically, malalignment can be caused by excessive tethering of one or two leaflet support structures, or by excessive stretching or tearing of these structures. Other less common causes include valvular infection, congenital abnormalities, and trauma. Valvular dysfunction can be caused by: stretching of the chordae tendineae (known as mitral valve prolapse), and in some cases, tearing of chordae tendineae 215 or papillary muscles (known as flail leaflet 220), as in... Figure 3A As shown in the diagram. Alternatively, if the leaflet tissue itself is superfluous, the valve may prolapse so that the occlusion occurs at a higher position in the atrium, opening the valve at a higher position in the atrium during ventricular systole. Either leaflet may prolapse or become flail-like. This condition is sometimes called degenerative mitral regurgitation.

[0071] In such Figure 3B In the excessive tethering illustrated, the leaflets of a structurally normal valve may fail to function properly due to annular enlargement or shape alteration (so-called annular dilatation 240). This type of functional mitral regurgitation is typically caused by myocardial failure and associated ventricular enlargement. Furthermore, the excessive volume overload caused by functional mitral regurgitation itself may exacerbate heart failure, ventricular and annular dilatation, and thus worsen mitral regurgitation.

[0072] Figures 4A-4B The illustration shows functional mitral regurgitation during systole. Figure 4A ) and degenerative mitral regurgitation ( Figure 4B The return of blood in BF. Figure 4A The increased size of the middle valve annulus, coupled with increased tethering due to hypertrophy of the ventricular 320 and papillary muscles 330, prevents the anterior leaflet 312 and posterior leaflet 314 from juxtaposing, thereby preventing occlusion. Figure 4B In this case, tearing of chordae tendineae 215 causes the posterior leaflet 344 to detach upwards into the left atrium, preventing its juxtaposition with the anterior leaflet 342. In either case, the result is blood returning to the atrium, which reduces the effectiveness of left ventricular compression.

[0073] Further descriptions of matching aids, tools, anchors, features, systems, and methods that can be used in conjunction with the disclosure herein can be found in the following applications, each of which is incorporated herein by reference in its entirety: U.S. Patent Application No. 13 / 099532, filed May 3, 2011; U.S. Patent Application No. 13 / 531407, filed June 22, 2012; U.S. Patent Application No. 14 / 313975, filed June 24, 2014; U.S. Patent Application No. 14 / 742199, filed June 17, 2015; U.S. Patent Application No. 14 / 749344, filed June 24, 2015; and U.S. Patent Application No. 10 / 419706, filed April 18, 2003.

[0074] In some embodiments, the occlusion assist device described herein can be deployed to cover the posterior leaflet, chordae tendineae, and papillary muscles. In some embodiments, the occlusion assist device is attached superiorly to the posterior aspect of the valve annulus and inferiorly to the posterior aspect of the left ventricle via annular anchors and / or ventricular anchors. In other embodiments, more than one annular anchor and / or more than one ventricular anchor can be used to attach the occlusion assist device. In some devices, one or more annular anchors can be replaced or supplemented by one or more atrial or commissural anchors, which in some embodiments may be annular. The occlusion assist device can be attached to the superior surface of the posterior valve annulus, the posterior atrial wall, or the valve annulus itself. An occlusion zone has been established between the occlusion assist device and the natural anterior leaflet. Similar occlusion assist devices can be used for both functional and degenerative mitral regurgitation, because leaflet occlusion failure occurs in both, regardless of the underlying mechanism of the dysfunction. In some implementations, different sized occlusion aids can be positioned such that the natural anterior leaflet and the occlusion aid are opposite each other at a properly established occlusion point, blocking blood flow during ventricular systole.

[0075] Various sizes of occlusive assist devices can be provided by varying the dimensions of the configuration for different anatomy. For example, there can be a height measured from the upper annular attachment site to the lowest edge of the occlusive assist device in a plane substantially perpendicular to the plane defined by the valve annulus, a depth between the occlusal point and the upper attachment site, and a protrusion between the posterior wall and the occlusal point at the height of the occlusal point. There are also inner and outer diameters of the occlusive assist device, typically larger in functional MR. During diastole, the occlusive assist device can remain in substantially the same position while the movement of the native anterior leaflet opens the valve, allowing blood to flow from the left atrium to the left ventricle with minimal restriction. In some embodiments, the surface of the occlusive assist device can balloon or stretch upwards during ventricular systole while the anchor remains stationary. This can be advantageous because it enhances the seal between the anterior or occlusive surface of the device and the native leaflet at the occlusal zone during systole. During diastole, the surface can return toward the anterior leaflet to its earlier initial position. This can provide an improved blood flow pathway between the atria and ventricles during diastole, thereby improving outflow from the atria via the occlusal assist device.

[0076] In some methods of use, the natural posterior leaflet remains in situ, and the occlusal assist device is attached superiorly to the posterior leaflet annulus or adjacent atrial wall. Various possible alternative implementations may have different attachment mechanisms. In other methods of use, the posterior leaflet is absent, has been surgically removed, or has been removed due to disease. In some methods of use, the natural leaflet is attached to the posterior surface of the occlusal assist device. In some methods of use, the occlusal assist device may be attached to the anterior surface of the posterior leaflet, rather than the annulus or atrial wall. These are some examples of variations, but other options are still considered. In some methods of use, an anchoring structure (not shown) can extend from the occlusal assist device through the atrial wall into the coronary sinus, where the anchoring structure attaches to a mating structure in the coronary sinus. In some methods of use, an anchoring structure, which may be a mechanical structure or a simple suture, can extend through the atrial wall and be anchored to the epicardial surface of the heart via a knot or mechanical unit such as a clip. Similarly, the lower attachment can reach the ventricular myocardium, enter the epicardium or pericardium through the apex of the heart, and be secured from the outside or at other attachment sites using alternative attachment units.

[0077] The occlusive assist devices described herein can exhibit a variety of desired characteristics. Some implementations do not rely on mitral annulus reshaping (e.g., through thermal contraction of the annulus tissue, implantation of an annulus prosthesis, and / or placement of the clasping mechanism above or below the valve plane or in the coronary sinus or related vessels). Advantageously, they also do not need to disrupt the leaflet structure or rely on the co-locking or fusion of the mitral leaflets. Several implementations can avoid dependence on ventricular reshaping and exhibit a passive implantation with limited offset after implantation, which can result in a very long fatigue life. Thus, the occlusive assist device can be secured through the posterior leaflet while otherwise maintaining the anatomy of the natural heart (e.g., ventricular, mitral annulus, etc.).

[0078] Mitral valve malalignment can be effectively relieved regardless of which leaflet(s) exhibit malalignment. The treatment described herein will utilize an occlusive device that can be rearranged during the procedure and even removed upon full deployment and / or after the onset or completion of tissue response, generally without damaging the valve structure. Nevertheless, the occlusive device described herein can be combined with one or more therapies that do rely on one or more of the properties excluded above. Occlusive devices can exhibit benign tissue healing and rapid endothelialization, which inhibits migration, thromboembolism, infection, and / or erosion. In some cases, the occlusive device will not exhibit endothelialization, but its surface will remain inert, which can also inhibit migration, thromboembolism, infection, and / or erosion.

[0079] Figures 5A-5B Two views are shown of one embodiment of an occlusion assist device 500. The occlusion assist device 500 may include a first surface 505 disposed toward the mal-occluded natural leaflet (in the case of the mitral valve, the posterior leaflet), and a second surface 515 disposed toward the anterior leaflet. The second surface 515 may include an occlusion surface 560. The upper edge 540 of the occlusion assist device 500 may be curved to conform to the overall shape of the valve annulus or adjacent atrial wall, as described herein. The upper edge 540 may be curved downward toward the posterior leaflet, as... Figure 5A As shown, or it bends upwards towards the atrial wall to match the overall shape of the left atrial wall, as... Figure 6 As shown in the illustrations and described in this article.

[0080] The occlusion assist device 500 may have a geometry that allows it to traverse the valve between attachment sites in the atrium and ventricle. In some embodiments, the attachment site is only in the atrium. In some embodiments, the attachment site is only near the valve annulus and commissure. The occlusion assist device 500 may not be attached near its lower edge 580. The occlusion assist device 500 does not require ventricular attachment. In some embodiments, the geometry of the occlusion assist device 500 helps maintain its position within the valve. In some embodiments, the occlusion assist device 500 is curved to cup the posterior leaflet. In some embodiments, the occlusion assist device 500 is curved posteriorly towards its upper edge 540. The occlusion assist device 500 may provide an occlusion surface 560 for occluding the anterior leaflet. Figure 5A and 5B The geometry is illustrated.

[0081] In some methods of use, the posterior leaflet may remain intact. The occlusion assist device 500 may be attached to the atrium or valve annulus to effectively close the posterior leaflet. In some methods of use, the posterior leaflet may be removed. In cases where the posterior leaflet has been removed or is already removed, the occlusion assist device 500 may replace the posterior leaflet. In some embodiments, the occlusion assist device 500 requires only valve annulus attachment. In some embodiments, the occlusion assist device 500 requires only attachment at a single point. This single point may be the central location of the occlusion assist device 500, for example, at the centrally located bushing. In some embodiments, the occlusion assist device 500 may be attached to the atrium or valve annulus along its edges. In some embodiments, the occlusion assist device 500 may be attached to the atrium or valve annulus at a location spaced apart from the edges of the occlusion assist device 500, for example, at the centrally located bushing.

[0082] The occlusion aid 500 may include an annular bushing 520 that engages the annular anchor 800. The annular anchor 800 may be engaged proximally via an actuator as described herein. The annular anchor 800 may include a sharp tip for engaging tissue. In some methods of use, the tip of the annular anchor 800 is within the annular bushing 520 during delivery of the occlusion aid 500. In some methods of use, the tip of the annular anchor 800 is above the annular portion 510 during delivery. The tip of the annular anchor 800 may remain recessed within the annular bushing 520 until the annular anchor 800 is rotated to engage tissue. In some embodiments, the occlusion aid 500 may be assembled externally, with the annular anchor 800 engaged via the annular bushing 520 and the actuator engaged with the annular anchor 800. The actuator may then retract into the delivery catheter, with the occlusion aid 500 in a folded position. The actuator may be operated individually by an operator to position the annular anchor 800 in place. Alternatively, the annular anchor 800 may be sequentially engaged with the occlusive aid 500 and / or actuator before or after deployment via the delivery catheter. The occlusive aid 500, once placed, can completely cover the posterior leaflet so that the occlusive aid 500 occludes with the anterior leaflet during systole and, together with the natural anterior leaflet, maintains a valve seal at the annular ring.

[0083] In some embodiments, the annular anchor 800 is an active anchor. The user can selectively engage or disengage the annular anchor 800 from the tissue. Unlike barbs or other passive anchors, the annular anchor 800 must be activated, for example, by rotation, to engage the tissue. The annular anchor 800 allows the occlusion aid 500 to be placed prior to engagement of the annular anchor 800. The occlusion aid 500 can contact the tissue without any attachment of the annular anchor 800. In some embodiments, the annular anchor 800 and the corresponding bushing 520 are centrally located on the occlusion aid 500. The annular anchor 800 and the corresponding bushing 520 are spaced apart from any edges of the occlusion aid 500. The central positioning of the annular anchor 800 and the corresponding bushing 520 prevents swaying of the occlusion aid 500 when supported by the annular bushing 520. The corresponding bushing 520 provides a favorable position for supporting and moving the occlusion aid 500.

[0084] The annular bushing 520 may have a built-in or coupled annular anchor 800. In some embodiments, the annular anchor 800 may be held within the annular bushing 520 by a pin as described herein. The pin may pass through a helical structure of the annular anchor 800 to prevent the annular anchor 800 from being removed from the annular bushing 520 by blunt force. The annular anchor 800 may include a helical structure rotatable relative to the annular bushing 520. In some embodiments, other anchors may be used. The annular anchor 800 may be in the form of a cord or other attachment unit extending from the occlusal assist device 500 through the interventricular septum to the right ventricle. The annular anchor 800 may be in the form of a cord or other attachment unit extending through the apex of the heart to the epicardium or pericardium. The annular anchor 800 may be fastened from outside the heart in a combined endo / epi procedure. When helical anchors are used, they may contain bio-inert materials such as platinum / Ir, nickel-titanium, and / or stainless steel.

[0085] In some embodiments, the occlusion assist device 500 may include a single central annular anchor 800 within the annular bushing 520. The occlusion assist device 500 may be delivered percutaneously via attachment of a delivery catheter to the annular bushing 520, as described herein. The occlusion assist device 500 may be configured to be adjustably arranged by removing and reattaching the annular anchor 800. The occlusion assist device 500 may be recaptured by removal of the annular anchor 800 and retraction of the occlusion assist device 500. The occlusion assist device 500 may also include secondary anchors, including commissural anchors, ventricular anchors, annular anchors, barbs, cords, or any other known securing device.

[0086] like Figures 5A-5BAs can be seen, the mating aid 500 may include a plurality of struts 530. In some embodiments, one or more of the struts 530 have one end terminating at the bushing 520 and another end extending radially outward toward one of the upper edge 540, side edges 570 and 575, and lower edge 580 of the mating aid 500. The struts 530 may extend outward from the bushing 520 in various directions and may be spaced apart from adjacent struts 530 at regular or irregular intervals. In some embodiments, adjacent struts 530 extend outward from the bushing at an angle of about 5 degrees to about 45 degrees, about 10 degrees to about 30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees relative to adjacent struts 530. The struts 530 may be arranged generally parallel to the longitudinal axis of the mating aid 500 to help maintain the shape of the mating aid 500 during placement. The struts 530 may allow the mating aid 500 to adopt a reduced configuration for deployment via a conduit. In some embodiments, the strut 530 forming part of the occlusal region of the implant has a maximum length greater than the strut 530 forming only part of the annular region of the implant. In some embodiments, the strut 530 forming part of the occlusal region of the implant may be at least about 10%, 20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than the strut 530 forming part of the annular region of the implant.

[0087] Figure 5A A view of the mating aid 500 with a valve annulus anchoring portion 535 is shown. The valve annulus anchoring portion 535 may be part of the strut 530. The valve annulus anchoring portion 535 is in Figure 5A The annular anchor portion 535 is shown extending downward from the occlusion aid 500. In other embodiments, the annular anchor portion 535 may extend from the occlusion aid 500 in other directions to engage tissue. In some embodiments, the annular anchor portion 535 includes one or more barbs with sharp tips. The annular anchor portion 535 may be a passive anchor.

[0088] In some embodiments, the occlusion aid 500 may include one or more retractable barbs. For example, the barbs may be retracted during delivery of the occlusion aid 500. For example, the barbs may be advanced after the occlusion aid 500 has been positioned relative to an anatomical structure. In some embodiments, the barbs are actively retracted and / or advanced. For example, the delivery catheter described herein may include a barb-coupled mechanism designed to retract and / or advance the barbs. In other embodiments, the barbs are passively advanced and / or retracted. In some embodiments, the occlusion aid 500 is delivered with the barbs in a retracted state. In some embodiments, the barbs may be covered by a valve body covering as described herein. In some embodiments, the interface between the tissue and the valve body covering pushes the valve body covering back and exposes the barbs. In some embodiments, the tissue dissolves and / or absorbs a portion of the valve body covering and exposes the barbs. In some embodiments, the movement of the pocket-shaped suture described herein advances the barbs. In some implementations, movement of the drawstring suture at the purse opening causes movement of the valve body covering to expose the barbs. Other configurations may be considered.

[0089] The valve annulus anchorage portion 535 can be limited. Figure 5B The diameter D1 shown may correspond in some embodiments to the distance between the inner and outer commissures of the natural valve, or the intracommissural distance (ICD). D1 may be 20-60 mm, and in some embodiments, a length of 35-45 mm is preferred, which most closely corresponds to the widest range of the human mitral valve ICD. In some embodiments, D1 may be the distance from the right fibrous trigone to the left fibrous trigone.

[0090] The occlusive aid 500 may include a generally annular portion 510. When the occlusive aid 500 is deployed, the annular portion 510 may be positioned above the natural leaflet. In some embodiments, the annular portion 510 may be bent toward or away from the annulus. The annular portion 510 may be concave. In other embodiments, the annular portion 510 may be substantially flat relative to the annulus. One or more of the struts 530 may be laterally bent from the bushing 520 toward the upper edge 540 to help maintain the shape of the annular portion 510 of the occlusive aid 500 during deployment. The occlusive aid 500 may be bent downward from the bushing 520 toward the annulus anchoring portion 535. In some embodiments, the occlusive aid 500 does not protrude toward the posterior leaflet. In some embodiments, the annulus anchoring portion 535 is the only point of contact between the posterior annulus of the mitral valve and the occlusive aid 500. The upper edge 540 may include an annular radius of curvature. The annular radius of curvature may be bent toward the annulus. The annular radius of curvature can be bent toward the mating surface at 560 degrees. In some embodiments, the annular radius of curvature can be 0mm-5mm, 5mm-10mm, 10mm-15mm, 15mm-20mm, 20mm-25mm, 25mm-30mm, etc.

[0091] The strut 530 may be made of a radiopaque material. In some embodiments, the strut 530 is made of an elastically deformable material such as a shape memory metal, such as nitinol, or a shape memory polymer. In some embodiments, the material is Elgiloy. In other embodiments, the strut 530 may be made of other materials, including stainless steel, polypropylene, high-density polyethylene (PE), polyester, acellular collagen matrix such as SIS, or other plastics. In other embodiments, the strut 530 may be a combination, such as a high-density PE sheath surrounding a core of ePTFE, polyester, and / or polypropylene. The strut 530 may have a circular cross-section, an oval cross-section, or a strip shape. In some embodiments, the strut 530 is a helical spring or a zigzag shape. The strut 530 may have a constant stiffness. In some embodiments, one or more struts 530 may have different stiffnesses along their length. The strut 530 may be stiffer at the annular end than at the ventricular end of the occlusal assist device 500. The strut 530 may be less stiff at the annular end than at the ventricular end of the occlusal assist device 500. The strut 530 may be stiffer at its midpoint, such as at an inflection point or curve. The strut 530, together with one or more other support structures, may form a frame. In some embodiments, one or more support structures may be provided extending parallel to the upper edge 540 of the mating aid 500 and helping to maintain the shape of the upper edge 540. In some embodiments, the strut 530 and / or other support structures of the frame may be laser-cut from a nitinol tube.

[0092] The occlusion aid body cover 550 can be made of a material such as ePTFE. Other materials used for the occlusion aid body cover 550 include polyester, polyurethane foam, polycarbonate foam, biological tissues (such as porcine pericardium, processed bovine pericardium, pleura, peritoneum), silicone, polyester, noncellular collagen matrix, etc. In some embodiments, the occlusion aid body cover 550 may include a foam material surrounded by ePTFE. In some embodiments, the use of sponge or foam material enhances the ability of the occlusion aid 500 to fold to a sufficiently small diameter to pass through the conduit. In some embodiments, the occlusion aid body cover 550 is non-porous. In other embodiments, the occlusion aid body cover 550 may have micropores to enhance endothelialization and cell attachment. The occlusion aid body cover 550 may also contain radiopaque materials or echo-enhancing materials for better visualization. Any support structure of the occlusion aid 500, including the strut 530 or the support interface including the bushing 520, may be coated with radiopaque materials such as gold or platinum, or impregnated with barium. The occlusion surface 560 may be coated with an echo-enhancing material. The occlusion aid body covering 550 may be coated with a material that inhibits thrombus formation, such as heparin-bonded compounds or quinoline and quinoxaline compounds, or with a material that accelerates endothelialization, or with an antibiotic that inhibits infection. In some embodiments, the pocket-shaped drawstring suture 1010 described herein may contain a radiopaque material or an echo-enhancing material for better visualization.

[0093] In some embodiments, the strut 530 may be sandwiched between layers of the engagement aid body cover 550. The engagement aid body cover 550 may be made of the same material on the first surface 505 and the second surface 515. Alternatively, the engagement aid body cover 550 may be made of different materials on the first surface 505 or a portion thereof and the second surface 515 or a portion thereof. In some embodiments, the strut 530 may be attached to or embedded in a single layer of the first surface 505 or the second surface 515 of the engagement aid body cover 550. In some embodiments, the strut 530 may be “stitched” through the engagement aid body cover 550. The valve annulus anchoring portion 535 may be the exposed end of the strut 530 from the engagement aid body cover 550.

[0094] The closing aid 500 may include a drawstring 1010 for the pocket opening. The drawstring 1010 may extend along a portion of the closing aid 500. The drawstring 1010 may extend along an upper edge 540 or a portion thereof. The drawstring 1010 may extend along a side edge 570 or a portion thereof. The drawstring 1010 may extend along a side edge 575 or a portion thereof. The drawstring 1010 may extend along a lower edge 580 or a portion thereof. The drawstring 1010 may extend along the perimeter of the closing aid 500 or a portion thereof. The drawstring 1010 may extend along one or more supports 530. The drawstring 1010 may extend in a straight path, a non-straight path, a curve, a semicircle, or any open or closed shape.

[0095] In some embodiments, the pocket-shaped drawstring suture 1010 may be sandwiched between layers of the valve body covering 550. For example, the pocket-shaped drawstring suture 1010 may be disposed in a cavity between layers of the occlusal assist device body covering 550. In some embodiments, the pocket-shaped drawstring suture 1010 may be attached to or embedded in a first surface 505 or a second surface 515 of a single layer of the valve body covering 550. In some embodiments, the pocket-shaped drawstring suture 1010 may be "sewn" through the occlusal assist device body covering 550. The pocket-shaped drawstring suture 1010 may pass through the first surface 505 to the second surface 515 and back to the first surface 505. The pocket-shaped drawstring suture 1010 may include one or more exposed ends from the occlusal assist device body covering 550. In an embodiment where the pocket-mouth drawstring suture 1010 is a loop, the pocket-mouth drawstring suture may include a loop from one or more exposed portions of the valve body covering.

[0096] The folding aid 500 can be folded by tightening the drawstring 1010 at the purse opening. The folding aid 500 can be unfolded by loosening the drawstring 1010 at the purse opening. One or more exposed ends or loops can be manipulated via a delivery tube or other tool to tighten or loosen the drawstring 1010 at the purse opening. The ability to fold or unfold the folding aid 500 can facilitate the recapture and / or rearrangement of the folding aid 500.

[0097] The closing aid 500 can be rotated by tightening or loosening one or more drawstring sutures 1010 at the pocket opening. For example, tightening or loosening one or more drawstring sutures 1010 at the side edge 570 or one or more drawstring sutures 1010 at the side edge 575 can rotate the closing aid 500. One or more drawstring sutures 1010 can be coupled to the closing aid 500 to enable multi-directional rotation.

[0098] The folding aid 500 can be deployed by loosening the drawstring suture 1010 at the purse opening. One or more exposed ends or loops can be manipulated by a delivery tube or other tool to tighten or loosen the drawstring suture 1010 at the purse opening. The ability to fold or deploy the folding aid 500 can facilitate the recapture of the folding aid 500 and / or the rearrangement of the folding aid 500.

[0099] The occlusion surface 560 of the occlusion assist device 500 can be adjusted by moving the purse-mouth pull-loop suture 1010. One or more exposed ends or loops can be manipulated by a delivery catheter or other tool to tighten or loosen the purse-mouth pull-loop suture 1010, thereby changing the curvature of the occlusion surface 560 in situ. The ability to adjust the curvature of the occlusion assist device 500 can facilitate conforming to the geometry of the heart, including the geometry of the anterior leaflet.

[0100] The annular size of the occlusion assist device 500 can be adjusted by moving the pocket-shaped drawstring suture 1010. One or more exposed ends or annexes can be manipulated by a delivery catheter or other tool to tighten or loosen the pocket-shaped drawstring suture 1010, thereby altering one or more dimensions of the occlusion assist device 500 in situ. The ability to adjust the size of the occlusion assist device 500 can facilitate conforming to the geometry of the heart.

[0101] The closing aid 500 may include one or more drawstring sutures 1010. In some embodiments, the closing aid 500 includes one, two, three, four, five, six, seven, eight, nine, ten, or more drawstring sutures. For example, the drawstring sutures 1010 may extend along the edges of the closing aid 500. When multiple drawstring sutures are provided, the drawstring sutures 1010 may be used together to change the configuration of the closing aid 500. When multiple drawstring-type sewing threads are provided for the purse opening, the drawstring-type sewing thread 1010 can be used independently to change the configuration of the closing auxiliary device 500.

[0102] Figure 5A The diagram further illustrates the copulatory device height, which corresponds to the distance between the lower edge 580 and the annular bushing 520, measured perpendicularly to the plane defined by the valve annulus. The copulatory device height can be 10-80 mm in some embodiments, and 40-55 mm in others. The copulatory device height can be 10-20 mm, 20-30 mm, 30-40 mm, 40-50 mm, 50-60 mm, 60-70 mm, 70-80 mm, etc.

[0103] Figure 5A The diagram illustrates the generally triangular shape of the mating aid 500, which has an upper edge 540, side edges 570 and 575, and a lower edge 580. In some embodiments, the upper edge 540 has a longer length than the lower edge 580, such that the lateral distance between the side edges 570 and 575 generally decreases from the upper to the lower part of the mating aid 500. For example, the length of the upper edge 540 may be in the range of 15-50 mm or 25-35 mm, while the length of the lower edge 580 may be in the range of 1-15 mm or 2-6 mm.

[0104] The annular bushing 520 can be a bushing, an eyelet, or any other fastening location known in the art. In some embodiments, the annular bushing 520 is located at the midpoint of D1. In some embodiments, the annular bushing 520 is located at the center to prevent swaying of the engagement aid 500 when supported by the annular bushing 520. In other embodiments, the annular bushing 520 is located at one of the engagement points. Although only one annular anchor 800 is shown, in other embodiments, two or more annular bushings 520 may be provided.

[0105] In some embodiments, the strut 530 may include a NiTi tube. In some embodiments, the strut 530 may be laser-cut from the tube. In some embodiments, the frame including one or more struts 530 and / or one or more support structures may be laser-cut from a single sheet of material. In some embodiments, the frame including one or more struts 530, annular bushing 520, and / or one or more support structures may be integrally formed. In some embodiments, the mating aid body cover 550 includes an ePTFE laminate. The laminate may surround one or more and / or one or more support structures in the strut 530 (e.g., one side, both sides, first side, second side). The strut 530 and / or one or more support structures may be surrounded by two or more laminated layers. The periphery of the annular portion 510 of the mating aid 500 may be cupped downwards. The periphery of the annular portion 510 of the mating aid 500 may be cupped upwards. The periphery of the annular portion 510 of the mating aid 500 may include secondary anchors such as a petal annular anchor portion 535.

[0106] In some embodiments, the annular anchor 800 and the annular bushing 520 form a single central anchoring system. In some embodiments, the occlusion aid 500 is secured to the tissue by only one annular anchor 800 passing through the bushing 520. In other embodiments, additional fixation is included. In some embodiments, the occlusion aid 500 is secured to the tissue by the aforementioned one annular anchor 800 passing through the bushing 520 and an annular anchoring portion 535 as described herein. The system may include features that allow rotational adjustment of the occlusion aid 500. For example, the bushing 520 and / or the annular anchor 800 may be coupled to a delivery catheter to allow axial movement and / or torque transmission. The occlusion aid 500 may be held stationary by the delivery catheter such that rotation of features of the delivery catheter, such as a handle, causes rotation of the occlusion aid 500. The occlusion aid 500 may be held stationary by the delivery catheter such that axial movement of features of the delivery catheter, such as a drive shaft, causes axial movement of the occlusion aid 500.

[0107] In some embodiments, the bushing 520 is located at a central position on the mitral valve 500. This central position can be the center of the annular portion 510. The central position can be between the side edges. The central position can be between the upper edge 540 and the mitral surface 560. The central position can enhance the stability of the mitral valve 500 when it is secured at a single location such as the bushing 520 and / or the annular anchor 800. The central position can be aligned with the structure of the mitral valve. The central position can be aligned along the mitral region.

[0108] In some embodiments, the occlusion aid 500 is delivered percutaneously as described herein. In some embodiments, the occlusion aid 500 is adjustable via a delivery catheter. For example, the occlusion aid 500 can be deployed and / or folded via the delivery catheter. For example, the occlusion aid 500 can be rotated about a fixed position of the annular bushing 520. For example, the occlusion aid 500 can be recaptured. For example, the occlusion aid 500 can be engaged and re-engaged via the delivery catheter. For example, the valve annulus anchor 800 can be detached from the tissue, and the delivery catheter can recapture the occlusion aid 500.

[0109] Figures 5C-5D The figures illustrate embodiments of the frame 565 of the mating aid 500. These figures illustrate the flattened pattern of the frame 565 before bending and / or shape fixing. In some embodiments, the frame 565 is cut from a tubular blank. In other embodiments, the frame 565 is cut from a flat blank such as a flat sheet of material. The frame 565, including portions thereof, can be laser-cut. The frame 565 may include one or more supports 530. Figure 5D In the embodiment shown, frame 565 includes twenty pillars 530, but other configurations are considered (e.g., one pillar, two pillars, three pillars, four pillars, five pillars, five to ten pillars, ten to fifteen pillars, fifteen to twenty pillars, twenty to twenty-five pillars, twenty-five to thirty pillars, etc.).

[0110] In some embodiments, one or more supports 530 are coupled to a backing 585. In some embodiments, the backing 585 is transverse to the direction of the supports 530. In the illustrated embodiments, the backing 585 is vertical or substantially vertical, and the supports 530 are horizontal or substantially horizontal. In some embodiments, the backing 585 is an annular bushing 520. For example, the two ends of the backing 585 can be joined using methods known in the art to form the annular bushing 520. For example, if the frame 565 is cut from a flat blank, the two ends are joined. In other embodiments, the frame 565 is formed from a tubular blank. The backing 585 can be part of an uncut tubular blank. If the frame 565 is formed from a tubular blank, it is not necessary to join the two ends of the backing 585. An uncut tubular blank can form the annular bushing 520. Figure 5DThe patterns of the frame 565 shown can be cut from a tubular blank, thereby eliminating the need for connecting the two ends of the backing. Other manufacturing methods for forming the frame 565 are considered. In other embodiments, the backing 585 forms at least a portion of the annular bushing 520. In some embodiments, the backing 585 surrounds at least a portion of the annular bushing 520. In some manufacturing methods, the backing 585 can be formed as a circle. In some manufacturing methods, once the backing 585 is formed as a circle, the support 530 extends radially outward from the backing 585. The backing 585 may include one or more openings designed to receive pins, as disclosed herein. In some manufacturing methods, the backing 585 is removed.

[0111] Reference Figure 5A and 5C Multiple struts 530 may extend from the annular bushing 520 to the lower end. In some embodiments, these struts 530 are longer than the other struts 530 of the frame 565. In some embodiments, the struts 530 may include anchors or barbs that interact with subvalvular structures, including the ventricular wall. In some embodiments, these struts engage the posterior leaflet or other anatomical structures. In some embodiments, ventricular anchoring is passive.

[0112] Reference Figures 5A-5D Multiple struts 530 may extend from the annular bushing 520 to the upper end. In some embodiments, these struts 530 are shorter than the other struts 530 of the frame 565. In some embodiments, these struts 530 form atrial anchors and / or valve annular anchoring sites 535 as described herein. In some embodiments, these struts engage the valve annulus or other anatomical structures. In some embodiments, the valve annulus anchoring is passive.

[0113] Reference Figure 5A and 5D Multiple struts 530 may extend from the annular bushing 520 to the side edges 570 and 575. In some embodiments, these struts 530 have a moderate length between the ventricular struts and the atrial struts. In some embodiments, these struts engage commissures or other anatomical structures. In some embodiments, the commissure anchorage is passive.

[0114] The support column 530 can have various lengths based on the desired shape of the mating auxiliary device 500. For example... Figures 5C-5D As shown, two or more pillars 530 have different lengths. Figures 5C-5D As shown, two or more pillars 530 have the same length. Figure 5CA schematic diagram of frame 565 is shown. One or more of the upper three pillars can form mating surface 560 and extend to the lower edge. One or more of the lower three pillars can form an annular portion and extend to the upper edge. Pillar 530 can be laser-cut from the tube. The length can be measured from the edge of the annular bushing 520 to the mating aid 500. The pillar length can range from 1 mm to 50 mm. For the annular portion 510, the pillar length can range from 5 mm to 35 mm. For the annular portion 510, the pillar length can be approximately 15 mm. For the mating surface 560, the pillar length can range from 20 mm to 35 mm. For the mating surface 560, the pillar length can be approximately 30 mm. Other configurations considering the range of support lengths include, for example, 5mm to 45mm, 10mm to 40mm, 15mm to 35mm, approximately 5mm, approximately 10mm, approximately 15mm, approximately 20mm, approximately 25mm, approximately 30mm, approximately 35mm, approximately 40mm, approximately 45mm, approximately 50mm, approximately 55mm, approximately 60mm, 1mm to 10mm, 5mm to 15mm, 10mm to 20mm, 15mm to 25mm, 20mm to 30mm, 25mm to 35mm, 30mm to 40mm, etc.

[0115] The width can be measured perpendicular to the length of the support column. The width of the support column can range from 0.1 mm to 2 mm. One or more supports can have an outer diameter or width of approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc. One or more supports 530 can have a varying width along the length of the support column. In some embodiments, one or more supports 530 taper gradually near the edge of the mating aid 500. In some embodiments, one or more supports 530 taper gradually near the annular bushing 520. One or more supports 530 can include a reduced diameter or taper at the connection between one or more supports 530 and the annular bushing 520. The taper near the annular bushing 520 can facilitate folding the occlusion aid 500. The taper near the annular bushing 520 can facilitate insertion of the occlusion aid 500 into the delivery catheter. The taper can reduce stress and / or strain in the strut 530 during folding. In some embodiments, the taper can contribute to a longer fatigue life. In some embodiments, one or more struts 530 include a tapering width. The width of the strut 530 can vary along the length of the strut 530. One or more struts 530 can include eyelets along the length of the strut 530. In some embodiments, the eyelets can reduce stress on the strut 530. In some embodiments, the eyelets can facilitate adhesion between the strut 530 and the valve body covering 550.

[0116] Thickness can be measured perpendicular to both the length and width of the support column. The thickness can be determined by the material thickness of the frame, as described herein. Support column thickness can range from 0.2 mm to 0.5 mm. One or more supports can have thicknesses of approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, less than 1.5 mm, less than 2 mm, etc.

[0117] One or more struts 530 may include barbs. In some embodiments, the barbs may be configured for placement near the ventricular end of the occlusion assist device 500. In some embodiments, the barbs may be bent out of the plane of the strut 530. In some embodiments, the barbs may have a bayonet configuration. In some embodiments, the barbs may have a sharp tip. In some embodiments, one or more struts 530 may be forked. In some embodiments, one or more struts 530 may include one or more zigzag portions. In some embodiments, the zigzag portions reduce stress on the strut 530 and / or increase its flexibility. In some embodiments, the zigzag portions facilitate attachment between the strut 530 and the occlusion assist device body cover 550.

[0118] In some embodiments, one or more pillars 530 may include supplemental barbs. In some embodiments, the supplemental barbs may be bent out of the plane of the pillar 530. In some embodiments, one or more portions of the pillar length are bent out of the surface of the pillar. For example, a portion of the pillar may be twisted or bent during manufacturing. In some embodiments, the portion bent out of the plane is shaped to engage tissue. In some embodiments, one or more pillars 530 may include an increased width to compensate for electropolishing or other post-manufacturing processes. In some embodiments, a backing 585 may include one or more features for engaging one or more delivery catheters as described herein. In some embodiments, a backing 585 may include one or more notches designed to engage with locking tabs or other features of the delivery catheter as described herein. In some embodiments, one or more pillars 530 may include a width larger than other pillars 530. In some embodiments, a frame 565 includes two or more pillars 530 having a width larger than other pillars 530. Two or more pillars 530 may facilitate visualization of the occlusion aid 500. In some embodiments, two or more pillars 530 with a larger width are designed to be placed near the occlusion when deploying the occlusion aid 500. In some embodiments, one or more struts 530 may have a smaller width compared to one or more other struts. In some embodiments, each strut 530 has the same width near the annular bushing 520. The backing 585 may be modified to connect to the delivery conduit, as described herein. The backing 585 may be designed to allow independent rotation of the anchor 800 within the bushing of the engagement aid 500.

[0119] Figure 5E , 5F The 5G diagram illustrates an implementation of a mating aid 500 without barbs. Figure 5E A three-dimensional schematic diagram of the engagement auxiliary device 500 is shown. Figure 5F A three-dimensional schematic diagram of the first surface 505 of the misaligned natural petal setting is shown. Figure 5GA cross-sectional schematic diagram including anchor 800 is shown.

[0120] Figure 5H , 5I Figure 5J shows an embodiment of an engagement auxiliary device 500 having a leaflet anchoring portion 545. For example... Figure 5A As shown, the annular anchoring portion 535, such as a barb, can extend along the edge of the mating auxiliary device 500. Figure 5H , 5I Figure 5J shows one embodiment of an engagement aid 500 having a leaflet anchoring portion 545 extending from a first surface 505 toward a poorly engaged natural leaflet arrangement.

[0121] Figure 5H A perspective view of the engagement auxiliary device 500 is shown, including an enlarged portion showing the leaflet anchoring portion 545. Figure 5I A three-dimensional schematic diagram of the first surface 505 of the misaligned natural petal setting is shown. Figure 5J A cross-sectional schematic diagram including anchor 800 is shown.

[0122] In some embodiments, the leaflet anchoring portion 545 includes one or more barbs with sharp tips. The leaflet anchoring portion 545 may be a passive anchor. In some embodiments, the occlusion aid 500 may include one or more retractable barbs. For example, the leaflet anchoring portion 545 may retract during delivery of the occlusion aid 500. For example, the leaflet anchoring portion 545 may advance after the occlusion aid 500 has been positioned relative to an anatomical structure. In some embodiments, the leaflet anchoring portion 545 actively retracts and / or advances. For example, the delivery catheter described herein may include a mechanism coupled to the leaflet anchoring portion 545 that is designed to retract and / or advance the barbs. In other embodiments, the leaflet anchoring portion 545 passively advances and / or retracts. In some embodiments, the leaflet anchoring portion 545 may be covered by a valve body covering as described herein. In some embodiments, the interface between the tissue and the valve body covering pushes the valve body covering back and exposes the leaflet anchoring portion 545. In some embodiments, tissue dissolves and / or absorbs a portion of the valve body covering and exposes the leaflet anchoring site 545. In some embodiments, movement of the pocket-shaped drawstring suture described herein advances the leaflet anchoring site 545. In some embodiments, movement of the pocket-shaped drawstring suture causes movement of the valve body covering to expose the leaflet anchoring site 545. Other configurations may be considered.

[0123] One or more struts 530 may have one or more barbs along the length of the strut 530. In the illustrated embodiment, each of the five struts 530 has four leaflet anchoring portions 545 along the length of the strut. Other configurations are considered that vary the number of struts 530 (e.g., one strut, two struts, three struts, four struts, five struts, six struts, seven struts, eight struts, nine struts, ten struts, etc.) and the number of leaflet anchoring portions 545 / struts 530 (e.g., one barb, two barbs, three barbs, four barbs, five barbs, six barbs, seven barbs, eight barbs, nine barbs, ten barbs, etc.). One or more struts 530 may have the same number of leaflet anchoring portions 545. Two or more struts 530 may have different numbers of leaflet anchoring portions 545. The leaflet anchoring portions 545 may be configured to engage the leaflets.

[0124] In some embodiments, the strut 530 may be sandwiched between layers of the valve body covering 550. In some embodiments, the strut 530 may be attached to or embedded in a first surface 505 or a second surface 515 of a single layer of the valve body covering 550. In some embodiments, the strut 530 may be "sewn" through the valve body covering 550. The first surface 505 may include one or more openings for leaflet anchoring portions 545. In other embodiments, the leaflet anchoring portions 545 may extend through the valve body covering 550. The leaflet anchoring portions 545 may have a predetermined curve that allows force to be applied to the first surface 505. The leaflet anchoring portions 545 may be sharpened to penetrate the valve body covering 550.

[0125] Frame 565 can have many advantages. Frame 565 can be formed in a flat pattern. Frame 565 may include edges forming an annular bushing 520. The edges may include longitudinal strips or a backing 585. One or more pillars 530 may extend from the backing 585. Figure 5C and 5D In the illustrated embodiments, one or more struts 530 are perpendicular to the longitudinal strip. The struts 530 are generally parallel. In some embodiments, the struts 530 are generally perpendicular to the backing 585 forming the annular bushing 520. In some embodiments, the struts 530 form an angle with the backing 585. For example, the longitudinal axis of the strut 530 may form an acute angle with the backing 585. This angle facilitates folding the struts 530 into the delivery catheter.

[0126] Frame 565 may be constructed from a single sheet of planar material. Frame 565 may be precisely cut using waterjet, laser etching, or similar techniques. Details including barbs on the struts 530 may be machined into the struts 530. Frame 565 may be bent and / or shaped to achieve the desired geometry. In some embodiments, backing 585 is folded to form a ring. Frame 565 may be rolled into a tubular shape. Backing 585 may be welded or fastened. When fastened end-to-end to form a ring, backing 585 may be considered as an annular bushing 520.

[0127] The support column 530 is bent into the desired configuration. The support column 530 may form one or more curves. The support column 530 may have one or more inflection points. The support column 530 may have concave and / or convex portions. One or more support columns 530 may include a radially outward taper (flare) starting at the inflection point. In some embodiments, the upper edge 540 bends upward away from the lower edge 580. In some embodiments, the upper edge 540 bends downward toward the lower edge 580. In some embodiments, one or more support columns 530 may be substantially flat. The support column 530 near the joint may be substantially flat. In some embodiments, the lower edge 580 bends backward toward the upper edge 540. In some embodiments, the lower edge 580 bends forward away from the upper edge 540.

[0128] The struts 530 may be evenly spaced around the circumference of the annular bushing 520. The struts 530 may also be unevenly spaced around the circumference of the annular bushing 520. A strut 530 extending along a portion of the circumference of the annular bushing 520 may differ from a strut extending along another portion of the circumference of the annular bushing 520. One or more designated portions of the struts 530 may be designed to be placed near the annular region of the heart. One or more designated portions of the struts 530 may be designed to be placed near the commissural region of the heart. One or more designated portions of the struts 530 may be designed to be placed near the ventricular region of the heart. The geometry of the radially extending struts 530 may be shaped to conform to the geometry of the patient. In some embodiments, the geometry is patient-specific. An operator may shape one or more struts 530 based on the geometry of the heart. An operator may modify the shape of one or more struts 530 based on the geometry of the patient.

[0129] Figure 5KThe dimensions of the mating aid 500 are illustrated. The mating aid 500 may include dimension A. Dimension A may be a linear protrusion or a rear protrusion. In some embodiments, dimension A may range from 1 mm to 40 mm. In some embodiments, dimension A may range from 4 mm to 24 mm. Other configurations of the dimension A range are considered, such as 5 mm to 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no rear protrusion, for example if the mating aid 500 is straight, then dimension A may be 0 mm.

[0130] The mating aid 500 may include a dimension B. In some embodiments, dimension B may be a radius of curvature. The radius of curvature may be concave or convex, as described herein. In some embodiments, dimension B may range from 1 / 16 inch to 1 / 2 inch. In some embodiments, dimension B may range from 1.5 mm to 13 mm. In some embodiments, dimension B may range from 1 / 4 inch to 3 / 8 inch. In some embodiments, dimension B may range from 6 mm to 9.5 mm. In some embodiments, dimension B may range from 1 mm to 15 mm. Other configurations of the dimension B range are considered, such as 2 mm to 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 11 mm, 6 mm to 10 mm, 7 mm to 9 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, etc. If there is no bend, for example if the mating auxiliary device 500 is straight, then dimension B can be 0 mm.

[0131] The mating aid 500 may include dimension C. In some embodiments, dimension C may be the radius of curvature near the upper edge 540. In some embodiments, dimension C may range from 1 mm to 10 mm. In some embodiments, dimension C may range from 1 mm to 5 mm. Other configurations considering the range of dimension C include, for example, 2 mm to 9 mm, 3 mm to 8 mm, 4 mm to 7 mm, 5 mm to 6 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, 1 mm to 15 mm, 5 mm to 10 mm, 3 mm to 9 mm, etc. If there is no curvature, for example if the mating aid 500 is straight, then dimension C may be 0 mm.

[0132] The occlusion assist device 500 may include a dimension D. Dimension D may be the height of the occlusion device. Dimension D may correspond to the distance between the lower edge 580, measured perpendicular to a plane defined by the valve annulus, and the atrial anchorage or annular bushing 520. In some embodiments, dimension D may range from 10 mm to 80 mm. In some embodiments, dimension D may range from 40 mm to 55 mm. Other configurations within the size D range, such as 5mm to 105mm, 10mm to 100mm, 15mm to 95mm, 20mm to 90mm, 25mm to 85mm, 30mm to 80mm, 35mm to 75mm, 40mm to 70mm, 45mm to 65mm, 50mm to 60mm, approximately 10mm, approximately 20mm, approximately 30mm, approximately 40mm, approximately 50mm, approximately 60mm, approximately 70mm, approximately 80mm, approximately 90mm, approximately 100mm, 10mm to 50mm, 20mm to 60mm, 30mm to 70mm, 40mm to 80mm, 50mm to 90mm, 60mm to 100mm, 70mm to 110mm, etc.

[0133] The mating aid 500 may include a dimension E. Dimension E may be a linear protrusion or a forward protrusion. In some embodiments, dimension E may range from 2 mm to 20 mm. In some embodiments, dimension E may range from 5 mm to 10 mm. Other configurations considering the range of dimension E include, for example, 0 mm to 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, approximately 16 mm, approximately 17 mm, approximately 18 mm, approximately 19 mm, approximately 20 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. If there is no forward protrusion, dimension E may be 0 mm.

[0134] The strut 530 of the mating aid 500 can form a back curve of the mating surface 560. The back bend can have a bending length of 30-100% of the distal end of the strut. In some embodiments, the back bend can have a bending length of at least 40% of the distal end of the strut. The angle of the back bend relative to the longitudinal axis of the mating aid 500 can be in the range of 0 degrees to 90 degrees. In some embodiments, the angle of the back bend can be in the range of 45 degrees to 90 degrees.

[0135] Figure 6 An embodiment of the engagement assist device 600 is illustrated. The engagement assist device 600 may be similar to the engagement assist device 500 and may include any of the features of the engagement assist device 500 described herein, with certain additional features described below.

[0136] The occlusion aid 600 may include an annular bushing 620 that engages an annular anchor (not shown). The annular bushing 620 may have a built-in or coupled annular anchor, such as the annular anchor 800 described herein. The annular anchor may include a helix rotatable relative to the annular bushing 620. In some embodiments, the occlusion aid 600 may include a single annular anchor within the annular bushing 620. The occlusion aid 600 may be percutaneously delivered as described herein via attachment of a delivery catheter to the annular bushing 620.

[0137] like Figure 6As can be seen, the mating aid 600 may include struts 630. In some embodiments, one, two, or more struts 630 have one end terminating at an annular bushing 620 and another end extending radially outward toward the upper edge 640, side edges 670 and 675, and lower edge 680 of the mating aid 600. The struts 630 may extend outward from the bushing 620. The struts 630 may be arranged generally parallel to the longitudinal axis of the mating aid 600 to help maintain the shape of the mating aid 600 during placement. The struts 630 may allow the mating aid 600 to adopt a reduced configuration for deployment via a conduit.

[0138] The occlusion assist device 600 may include an annular portion 610. When the occlusion assist device 600 is deployed, the annular portion 610 may be positioned above the annulus of the natural leaflet and form a flange as shown. In some embodiments, the annular portion 610 may be curved upward, for example, away from the annulus and in a direction substantially opposite to and substantially parallel to the occlusion surface 660, and form the uppermost portion of the occlusion assist device 600 upon implantation. The annular portion 610 may be convex. In other embodiments, the annular portion 610 may be substantially flat relative to the annulus. One or more of the struts 630 may be laterally curved from the annular bushing 620 toward the upper edge 640 to help maintain the shape of the annular portion 610 of the occlusion assist device 600 during deployment. The occlusion assist device 600 may be curved upward from the annular bushing 620. In some embodiments, the upper edge 640 does not protrude toward the posterior leaflet. The upper edge 640 may include an annular radius of curvature. The annular radius of curvature may be curved away from the annulus. The annular radius of curvature may be curved toward the occlusion surface 660. In some embodiments, the annular radius of curvature can be 0mm-5mm, 5mm-10mm, 10mm-15mm, 15mm-20mm, 20mm-25mm, 25mm-30mm, or a range including any two of the aforementioned values. The mating auxiliary device body cover 650 can be similar to the mating auxiliary device body cover 550 described herein.

[0139] In some embodiments, the periphery of the annular portion 610 faces upward and is cup-shaped in a direction substantially opposite to the longitudinal axis of the mating surface 660. In some embodiments, the mating aid 600 includes a valve annular anchoring portion similar to the valve annular anchoring portion 535. In other embodiments, the mating aid 600 does not include, for example, Figure 6 The valve ring anchoring part shown in the figure.

[0140] Figures 7A-7E An embodiment of the engagement assist device 700 is illustrated. The engagement assist device 700 may be similar to the engagement assist device 500 or 600 and includes any of the features described herein, with certain elements described below.

[0141] The mating auxiliary device 700 may include a first surface 705 and a second surface 715. Figure 7A The illustration shows a perspective view of a first surface 705 or a lower surface positioned toward a poorly apposed natural leaflet (in the case of the mitral valve, the posterior leaflet). Figure 7B The illustration shows a perspective view of a second surface 715 or an upper surface that can be positioned facing the anterior leaflet. The second surface 715 may include an occlusion surface 760. The upper edge 740 of the occlusion aid 700 can be curved to conform to the overall shape of the valve annulus or adjacent atrial wall. The upper edge 740 can be curved downwards towards the posterior leaflet, as... Figure 7B As shown in the image. Figure 7C The illustration shows a top view of the engagement auxiliary device 700.

[0142] Figures 7A-7C A view of an engagement aid 700 with an annular bushing 720 is shown. The engagement aid 700 may include an annular bushing 720 designed to engage a valve annular anchor 800. The valve annular anchor 800 may engage proximally via a actuator as described herein. The annular bushing 720 may have a built-in or coupled valve annular anchor 800. The valve annular anchor 800 may include a helix rotatable relative to the annular bushing 720. The engagement aid 700 may be percutaneously delivered as described herein via attachment of a delivery catheter to the annular bushing 720.

[0143] like Figures 7A-7C As can be seen, the engagement assist device 700 may include a strut 730. In some embodiments, one or more struts 730 have an end terminating at the annular bushing 720 and facing... Figure 7B The upper edge 740, side edges 770 and 775, and lower edge 780 of the mating aid 700 shown extend radially outward at the other end. The valve annulus anchoring portion 735 is located at... Figure 7B The image shows an extension downward from the main body of the engagement auxiliary device 700. The annular anchor 800 can be an active anchor. The annular anchor portion 735 can be a passive anchor, such as a barb. The annular anchor portion 735 can be located at the distal end of one or more supports 730.

[0144] When the occlusion assist device 700 is deployed, the annular portion 710 may be positioned above the natural leaflet. In some embodiments, the annular portion 710 may be bent toward the valve annulus or atrial wall. One or more of the struts 730 may be laterally bent from the bushing 720 toward the upper edge 740 to help maintain the shape of the annular portion 710 of the occlusion assist device 700 during deployment. The occlusion assist device 700 may be bent downward from the annular bushing 720 toward the valve annulus anchorage 735. The annular portion 710 may be concave. In some embodiments, one or more support structures may be provided extending parallel to the upper edge 740 of the occlusion assist device 700 and helping to maintain the shape of the upper edge 740. In some embodiments, the struts 730 and / or other support structures of the frame may be laser-cut from a nitinol tube. The valve body covering 750 may be made of materials as described herein.

[0145] In some embodiments, the mating aid 700 includes active anchors such as a petiole anchor 800. In some embodiments, the mating aid 700 includes passive anchors such as a petiole anchor portion 735. The petiole anchor portion 735 may include barbs at the tips of one or more posts 730.

[0146] The occlusion assist device 700, as well as the occlusion assist devices 500 and 600 described herein, may include one or more markers 900. Markers 900 may be disposed on any portion of the occlusion assist device 500, 600, 700, or any of its components such as struts 530, 630, 730, annular bushings 520, 620, 720, the drawstring suture 1010, and / or any portion of the annular anchoring portions 535, 735. In some embodiments, markers 900 are disposed on the annular anchor 800. In other embodiments, markers 900 are integrally formed with the occlusion assist device 500, 600, 700, or the annular anchor 800. Multiple markers 900 may be arranged in a specific pattern on the occlusion assist device to provide operators with fluoroscopic visual assistance for accurately orienting and positioning the occlusion assist device 500, 600, 700, and / or the annular anchor 800 within the patient's heart.

[0147] In some embodiments, the markers 900 may be radiopaque, or they may be covered by radiographic markers. During the delivery of the occlusion assist devices 500, 600, 700 and / or the annular anchor 800, the markers 900 may be visualized using a fluoroscope. The markers 900 can assist in the placement of the occlusion assist devices 500, 600, 700 and / or the annular anchor 800 within the patient's heart. In some embodiments, torque may be applied to the annular anchor 800 to drive it into the tissue. To provide feedback on whether the annular anchor 800 is properly secured, fluorescein markers 900 may be present on the annular anchor 800. The markers may be located proximally. These markers 900 can inform the medical team how far the annular anchor 800 may have traveled toward the annular bushings 520, 620, 720, and provide information about whether the annular anchor 800 is properly secured in place. In some implementations, to ensure proper torque application, the torque level at the handle can rapidly increase as the annular anchor 800 descends to its lowest point on the annular bushings 520, 620, 720. The system described herein may include one or more markers 900 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, more than one, more than two, more than three, more than four, etc.). The system described herein may include more than two different markers 900. Different markers may indicate different components of the system, different parts of the engagement aids 500, 600, 700, or arrangement points such as nearest point, farthest point, centerline, etc.

[0148] Figures 7D-7E The illustration shows one embodiment of a commutation assist device 700 deployed within a mitral valve model of the heart. (Refer to previous image) Figure 1F In the anastomosis zone CL between the leaflets, it is not a simple line, but rather... Figure 7C The curved funnel-shaped surface interface is shown. The first 110 (anterior-lateral or left-side) and the second 114 (posterior-medial or right-side) juncture is where the anterior leaflet 12 and the posterior leaflet meet at the anteroposterior region, forming the anteroposterior line (CL). As shown in Figure 7D Most clearly visible in the axial view of the atrium, the axial cross-section of the occlusal region typically shows a curved line CL, which is separated from the centroid of the valve annulus and from the opening through the valve during diastole. Furthermore, the leaflet edges are serrated, especially the posterior leaflet compared to the anterior leaflet. Malalignment can occur between one or more of these AP (anterior-posterior) segments A1 / P1, A2 / P2, and A3 / P3, causing the characteristics of malalignment to vary along the curve of the occlusal region CL, as shown in... Figure 1F As shown in the image.

[0149] In some embodiments, the occlusion aid 700 is positioned above the posterior leaflet to create a new surface to which the natural leaflet (here, the anterior leaflet) can occlude. The mitral valve is shown having an anterior leaflet 12. An occlusion zone exists between the anterior leaflet 12 and the occlusion surface 760 of the occlusion aid 700.

[0150] Now refer to Figure 8A The illustration shows aspects of a delivery catheter 1000. The delivery catheter 1000 may include a control handle. The delivery catheter 1000 may include a tip deflection control 1001. The tip deflection control 1001 can deflect the distal portion of the delivery catheter 1000. This can facilitate the placement of occlusion aids 500, 600, 700 within the mitral valve. The delivery catheter 1000 can be inserted into a transseptal sheath (not shown). The transseptal sheath allows the delivery catheter to be introduced into the left atrium. The delivery catheter 1000 may also include one or more ports 1002, such as flushing, perfusion, and / or aspiration ports, to remove air from the system and allow fluids such as saline or contrast agents to be injected into the implantation site. The catheter 1000 may include a catheter shaft 1006. The catheter 1000 may include an implant inserter 1007.

[0151] The delivery catheter 1000 may include an implant control handle 1003. The implant control handle 1003 can control the movement of the occlusion aids 500, 600, and 700. The implant control handle 1003 can fold the occlusion aids 500, 600, and 700. The implant control handle 1003 can unfold the occlusion aids 500, 600, and 700. Arrow 1003a indicates the direction of movement of the implant control handle 1003 for folding and / or unfolding the occlusion aids 500, 600, and 700 via the delivery catheter 1000. The implant control handle 1003 can rotate the occlusion aids 500, 600, and 700. Arrow 1003b indicates the direction of movement of the implant control handle 1003 for rotating the occlusion aids 500, 600, and 700.

[0152] The implant control handle 1003 may be internally connected to the occlusion aids 500, 600, 700 to allow axial movement and / or torque transmission. For example, the implant control handle 1003 of the delivery catheter 1000 may be coupled to annular bushings 520, 620, 720. For example, the implant control handle 1003 may be connected to one or more pocket-shaped drawstring sutures 1010 that can control the deployment of the occlusion aids 500, 600, 700. The pocket-shaped drawstring sutures 1010 may facilitate folding and / or unfolding of the occlusion aids 500, 600, 700 as described herein. The pocket-shaped drawstring sutures 1010 may facilitate rotation of the occlusion aids 500, 600, 700 as described herein. In some embodiments, the delivery catheter 1000 is releasably engaged with the engagement aids 500, 600, 700 so that axial movement and torque can be transmitted from the delivery catheter 1000 to the engagement aids 500, 600, 700.

[0153] In some embodiments, the tip 1300 of the delivery catheter 1000 is releasably coupled to the annular bushings 520, 620, 720. For example, the tip 1300 of the delivery catheter 1000 can be locked onto the annular bushings 520, 620, 720 such that movement of the delivery catheter 1000 causes movement of the engagement aids 500, 600, 700. In some embodiments, the system includes a release mechanism between the delivery catheter 1000 and the annular bushings 520, 620, 720.

[0154] The annular bushings 520, 620, and 720 may have a feature that allows locking using the tip 1300 of the delivery catheter 1000. (Refer to previous section) Figures 5A-7E The annular bushings 520, 620, and 720 may include one or more features for engaging a portion of the delivery catheter 1000. These features may include, for example... Figure 5A The illustration shows one or more notches in the liner 520 of the implant. The feature may include, for example... Figure 9A The internal flange shown is illustrated. This feature may include a window accessible from the outside of bushings 520, 620, and 720, such as... Figure 8CAs shown in the diagram. The features may include any structure or mechanism capable of coupling the annular bushings 520, 620, 720 and a portion of the delivery conduit 1000. In some embodiments, the annular bushings 520, 620, 720 and the delivery conduit 1000 are coupled via a bolted mechanism. For example, the annular bushings 520, 620, 720 may include female threads and the distal end of the delivery conduit 1000 may include male threads. In some embodiments, the annular bushings 520, 620, 720 and the delivery conduit 1000 are coupled via a lasso and pin configuration. For example, the annular bushings 520, 620, 720 may include pins such as outwardly extending pins, and the distal end of the delivery conduit 1000 may include a ring or lasso designed to be tightened around the pin. Other configurations may be considered.

[0155] Figure 8B The engagement aids 500, 600, and 700, coupled to the delivery conduit 1000, are shown. The engagement aids 500, 600, and 700 can be folded or unfolded as shown by the dashed lines by moving along arrow 1003a. The engagement aids 500, 600, and 700 can be rotated as shown by moving along arrow 1003b.

[0156] Reference Figure 8C The delivery catheter 1000 may include a tip 1300. The distal end of the tip 1300 may include a distal locking lug. In some embodiments, the tip 1300 includes a plurality of pre-bent or pre-shaped locking lugs. In some embodiments, the tip includes two, three, four, five, multiple, or numerous locking lugs, etc. The “AT-lock” (axial torsion lock) may include a nitinol locking lug on the tip 1300. In some embodiments, the locking lug of the tip 1300 may be driven by a sheath 1350. In some embodiments, the sheath 1350 is hollow to allow movement of other components described herein, such as actuators. Movement of the sheath 1350 may force the locking lug to engage inwardly with annular bushings 520, 620, 720. In some embodiments, the locking lug of the tip 1300 engages features such as windows or flanges on the annular bushings 520, 620, 720. In some embodiments, movement of the sheath 1350 in the opposite direction can cause the annular bushings 520, 620, 720 to be released from the tip. In other embodiments, the locking lugs of the tip 1300 can be driven by a central pin (not shown) inserted into the tip 1300. In some embodiments, the central pin is hollow to allow movement of other components described herein, such as actuators. Movement of the central pin can force the locking lugs to engage outward with the annular bushings 520, 620, 720.

[0157] In some embodiments, the distal end of the tip 1300 can be actuated to lock the delivery catheter 1000 to the annular bushings 520, 620, 720. In some embodiments, the distal end of the tip 1300 can be actuated to unlock the delivery catheter 1000 from the annular bushings 520, 620, 720. As described herein, after the annular bushings 520, 620, 720 are released from the tip 1300, secondary structures such as pocket-shaped drawstring sutures can remain coupled to the engagement aids 500, 600, 700. In some embodiments, when the delivery catheter 1000 is unlocked, one or more of the secondary structures described herein, such as pocket-shaped drawstring sutures, can remain in their relative positions between the delivery catheter 1000 and the annular bushings 520, 620, 720. During the process, the tip 1300 can be repeatedly locked and unlocked.

[0158] Refer to the return Figure 8A The delivery catheter 1000 may include an anchor control handle 1004. In some embodiments, the anchor control handle 1004 may release the annular anchor 800 and / or the engagement aids 500, 600, 700. In some embodiments, the anchor control handle 1004 may engage the annular anchor 800, for example, by rotating the annular anchor 800 and / or axially moving the annular anchor 800. In some embodiments, the anchor control handle 1004 may disengage the annular anchor 800. In some embodiments, the anchor control handle 1004 may control an actuator 1200 configured to apply torque. In some embodiments, the anchor control handle 1004 may control an actuator 1200 configured to apply tension and / or release the engagement aids 500, 600, 700. In some embodiments, the anchor control handle 1004 may control an actuator 1200 configured to apply both tension and torque.

[0159] Anchor control handle 1004 of delivery conduit 1000 can be coupled to an annular anchor 800 to allow torque to be transmitted to the annular anchor 800. Anchor control handle 1004 allows for simple manipulation of the torque or position of the annular anchor 800. Arrow 1004a indicates the direction of movement of anchor control handle 1004 for engaging or disengaging the annular anchor 800. For example, moving anchor control handle 1004 toward the annular anchor 800 can engage actuator 1200 with the annular anchor 800. Arrow 1004b indicates the direction of movement of anchor control handle 1004 for transmitting torque to the annular anchor 800. In some embodiments, arrow 1004b indicates the direction of release from the annular anchor 800. For example, additional application of torque can twist actuator 1200 out of engagement with the annular anchor 800.

[0160] One implementation of the valve ring anchor 800 is in Figure 9A Detailed illustrations are provided. Figure 9A Other components of the delivery conduit 1000, such as those engaging the annular bushings 520, 620, and 720, are not shown. The annular anchor 800 can be coupled to the actuator 1200 in various ways, as described herein. The annular anchor 800 can be coupled to the engagement aids 500, 600, and 700 in various ways. In some embodiments, the annular bushings 520, 620, and 720 may have a pin 820. The pin 820 may provide a portion around which the helical structure 815 of the annular anchor 800, as shown, can be wound. The annular anchor 800 may have a shoulder 805. The shoulder 805 may be mounted around the outside of the actuator 1200 of the delivery conduit 1000.

[0161] In some embodiments, the actuator 1200 is releasably coupled to the annular anchor 800. The actuator 1200 can be coupled and / or controlled via the anchor control handle 1004 described herein. One or more actuators 1200 can deliver torque to drive the annular anchor 800 into tissue. One or more actuators 1200 can deliver tension to support and / or release the annular anchor 800. In some embodiments, a single actuator 1200 delivers torque and tension. In other embodiments, two or more actuators 1200 deliver torque and tension. For example, the actuator 1200 can be locked to the annular anchor 800 such that movement of the actuator 1200 causes movement of the annular anchor 800. In some embodiments, the system includes a release mechanism between the actuator 1200 and the annular anchor 800. In some embodiments, the distal end of the actuator 1200 can be actuated to lock the actuator 1200 to the annular anchor 800. In some embodiments, the distal end of the actuator 1200 can be actuated to unlock the actuator 1200 from the annular anchor 800. In some embodiments, when the actuator 1200 is unlocked, one or more secondary structures, such as a purse-mouth drawstring suture, can be held in relative position between the delivery catheter 1000 and the annular anchor 800. During the procedure, the actuator 1200 can be repeatedly locked and unlocked.

[0162] Figure 9BAn embodiment of the actuator 1200 is illustrated. The actuator 1200 may include a torque shaft 1205. The torque shaft 1205 may include an annulus 1210. The annulus 1210 may engage a pin 1215, extending and looping around a tension pin 1270 and through an anchor 800. Rotation of the torque shaft 1205 may apply torque to the torque pin 1275, thereby causing rotation of the annulus anchor 800. In some embodiments, the annulus anchor 800 may include a torque pin and a tension pin. Another actuator (not shown) may apply torque to the tension pin to apply tension to the annulus anchor 800. One or more actuators 1200 may engage the annulus anchor 800 to deliver torque. One or more actuators 1200 may engage the annulus anchor 800 to deliver tension. In some embodiments, the delivery of the annulus anchor 800 is independent of rotation of the engagement aids 500, 600, 700.

[0163] Figure 9C An embodiment of the actuator 1200 is illustrated. The actuator 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor mating cap 1225. The anchor mating cap 1225 may engage the annular anchor 800 in a single orientation or one of multiple orientations. In some embodiments, the annular anchor 800 includes a protrusion 1230, and the anchor mating cap 1225 is designed to receive the protrusion 1230. In other embodiments, the annular anchor 800 includes a recess (not shown) to receive a mating protrusion (not shown) on the anchor mating cap 1225. Rotation of the torque shaft 1220 may apply torque to the annular anchor 800. Another actuator 1235 may apply tension to the annular anchor 800. In some embodiments, the actuator 1235 may include a release bolt. In other embodiments, a release bolt may be used. Figure 9B The annular and pin release mechanism described herein. A release bolt can be rotated to release the annular anchor 800. One or more actuators 1200 can engage the annular anchor 800 to deliver torque. One or more actuators 1200 can engage the annular anchor 800 to deliver tension.

[0164] Figure 9DAn embodiment of an actuator 1200 and a petiole annular anchor 800 is illustrated. The actuator 1200 may include a torque shaft 1220. The torque shaft 1220 may include an anchor mating cap 1225. In some embodiments, the petiole annular anchor 800 includes a protrusion 1230, and the anchor mating cap 1225 is designed to receive the protrusion 1230. In other embodiments, the petiole annular anchor 800 includes a recess (not shown) to receive a mating protrusion (not shown) on the anchor mating cap 1225. Two or more wires 1240, 1245 may apply tension to the petiole annular anchor 800. In some embodiments, wire 1240 serves as a pin, and wire 1245 terminates in a ball. In the held state, wires 1240, 1245 are arranged within an opening in the petiole annular anchor 800. The opening is too small to allow the pin and ball ends of wires 1240, 1245 to pass side by side. In some applications, wire 1240 is first retracted. The retraction of wire 1240 creates sufficient space to allow wire 1245 to retract. Wires 1240 and 1245 can be driven to release the annular anchor 800. One or more actuators 1200 can engage the annular anchor 800 to deliver torque. One or more actuators 1200 can engage the annular anchor 800 to deliver tension.

[0165] Figure 9E An embodiment of the actuator 1200 is illustrated. The actuator 1200 may include a torque shaft 1255. A shoulder 805 may have features such as a window 810, which can be locked using one or more distal locking lugs 1265 of the torque shaft 1255. The distal locking lugs 1265 may include a nitinol material such as a shape-set NiTi clip. The distal locking lugs 1265 can be pushed outward into the window 810 by the actuator 1260. The actuator 1260 acts as a release mechanism. Longitudinal movement of the actuator 1260 toward the annular anchor 800 can push the distal locking lugs 1265 outward toward the window 810. Longitudinal movement of the actuator 1260 away from the annular anchor 800 can restore the distal locking lugs 1265 to their intermediate configuration and disengage from the window 810. The distal locking lugs 1265 engaging with the window 810 of the annular anchor 800 can allow axial movement transmission between the torque shaft 1255 and the annular anchor 800. The distal locking lug 1265, which engages with the window 810 of the annular anchor 800, allows torque transmission between the torque shaft 1255 and the annular anchor 800. In embodiments where the annular anchor 800 is integrated into or captured by annular bushings 520, 620, 720, the distal locking lug 1265, which engages with the window 810, allows axial movement between the delivery catheter and the anastomosis aids 500, 600, 700.

[0166] In some embodiments, an advantage is that the annular anchor 800 can rotate independently of the occlusion aids 500, 600, and 700. As described herein, the occlusion aids 500, 600, and 700 are coupled to the delivery catheter 1000. As described herein, the annular anchor 800 is independently coupled to the actuator 1200. The annular anchor 800 can rotate independently of the annular bushings 520, 620, and 720. When the annular anchor 800 is rotated to engage tissue, the annular bushings 520, 620, and 720 can remain fixed.

[0167] In some methods, the valve annulus anchor 800 may be pre-loaded onto the occlusion aids 500, 600, 700 and coupled to the actuator 1200 during the process of mounting the occlusion aids 500, 600, 700 onto the delivery catheter 1000. This can occur before the occlusion aids 500, 600, 700 are pulled into another portion of the implant sheath and / or the delivery catheter 1000 and are ready for insertion into the femoral vein. As disclosed herein, torque can be applied to drive the valve annulus anchor 800 into the tissue. In some embodiments, to ensure proper torque application, the torque level at the handle can rapidly increase as the valve annulus anchor 800 is lowered to its lowest point on the annular bushings 520, 620, 720. This increased torque level can be felt at the handle, providing feedback that torque has been properly applied. In other embodiments, radiopaque markings can aid in visually determining the level of anchor engagement within the tissue. In some implementations, the markings may be located on the valve annulus anchor 800 and / or the mating aids 500, 600, 700.

[0168] Figure 10-15 Various method steps are shown that can be performed during the use of the occlusion aids 500, 600, and 700. The methods may include the step of folding the occlusion aids 500, 600, and 700. The methods may include the step of coupling the occlusion aids 500, 600, and 700 to the delivery catheter 1000. The methods may include the step of coupling the locking lug 1265 to the valve annulus anchor 800 and / or the occlusion aids 500, 600, and 700. The methods may include any of the steps disclosed herein for manufacturing the occlusion aids 500, 600, and 700.

[0169] In some embodiments, an advantage is that the occlusion aids 500, 600, and 700 can be delivered using a bushing-guided orientation. In this method of use, the annular bushings 520, 620, and 720 can be moved into position relative to the anatomical structure before another portion of the occlusion aids 500, 600, and 700. In some methods of use, the ventricular end of the occlusion aids 500, 600, and 700 can be held within the delivery catheter 1000 until the annular bushings 520, 620, and 720 are positioned. In some methods of use, the occlusion aids 500, 600, and 700 can be deployed once the annular bushings 520, 620, and 720 and / or the valve annulus anchor 800 are engaged with the tissue. In some methods of use, the ventricular end of the occlusion aids 500, 600, and 700 can be positioned once the annular bushings 520, 620, and 720 and / or the valve annulus anchor 800 are engaged with the tissue.

[0170] In some embodiments, an advantage is that the occlusion aids 500, 600, and 700 can be delivered using a strut-guided orientation. In this method of use, one or more of the struts 530, 630, and 730 of the occlusion aids 500, 600, and 700 can be moved into position relative to the anatomical structure before another portion of the occlusion aids 500, 600, and 700 is positioned. In some methods of use, the occlusion aids 500, 600, and 700 can be deployed or partially deployed before the arrangement of the annular bushings 520, 620, and 720. In some methods of use, the annular bushings 520, 620, and 720 can be held within the delivery catheter until one or more of the struts 530, 630, and 730 are positioned. In some methods of use, once the struts 530, 630, and 730 are positioned, the valve annulus anchor 800 engages with the tissue.

[0171] Figure 10 An embodiment of transseptal traversal is illustrated. The method may include femoral vein access. Access can be achieved via a vessel such as the femoral vein to reach a cardiac chamber such as the right atrium. The left ventricle 1380 and its papillary muscles 1360 are also shown. The method may include the steps of transseptal puncture and traversal to the left atrium 1320 using a standard transseptal kit 1330. The method may include the steps of exchanging a custom transseptal sheath and delivery catheter 1000, as described herein. The transseptal puncture kit may be replaced with a transseptal sheath and dilator, and the dilator may be replaced with an implantable delivery catheter, which may be disclosed herein and in U.S. Patent No. 8,888,843 to Khairkhahan et al., which is incorporated herein by reference in its entirety. The method may include the step of removing the dilator. The method may include the step of advancing the delivery catheter 1000. However, other routes such as transapical, transatlantic, femoral artery, brachial artery, etc., are also within the scope of this invention.

[0172] Figure 11 The illustration shows the initial advance of occlusion assist devices 500, 600, and 700. The method may include advancing the occlusion assist devices 500, 600, and 700 within a retraction sheath. The retraction sheath may include a tip having a plurality of petals radiating from a central bushing 1420. The retraction sheath may be positioned within a transatrial septal sheath 1400. The mitral valve is shown at the base of the left atrium 1440. The method may include advancing the annular portions 510, 610, and 710 toward the valve annulus before advancing the occlusion surfaces 560, 660, and 760 toward the valve annulus. The method may include deploying the ventricular end or inferior surface after deploying the annular portion 510.

[0173] Figure 12 The illustration shows a partial deployment of occlusion assist devices 500, 600, and 700. The occlusion assist devices 500, 600, and 700 can advance towards a target location under imaging guidance such as ultrasound or fluoroscopy. Annular anchors 800, coupled to the occlusion assist devices 500, 600, and 700, are engaged in the tissue. The anchor torque axis 1540 can rotate internally and independently of the rotation of the implant torque axis (not shown). Controlled release of the pocket-shaped suture 1010 around the periphery of the occlusion assist devices 500, 600, and 700 allows the occlusion assist devices 500, 600, and 700 to deploy. Before the occlusion assist devices 500, 600, and 700 are fully deployed, rotational adjustments can be made to align the internal (ventricular) portions of the occlusion assist devices 500, 600, and 700 with the valve orifice 1580.

[0174] The method may include the step of advancing the occlusion aids 500, 600, 700 toward a target position. The method may include the step of advancing the annular bushings 520, 620, 720 toward a target position. The method may include the step of advancing the valve annulus anchor 800 coupled to the annulus bushings 520, 620, 720 toward a target position. The method may include echo- or fluoroscopic guidance of the valve annulus anchor 800, bushings 520, 620, 720, and / or occlusion aids 500, 600, 700. The method may include engaging the valve annulus anchor 800 in tissue. The method may include rotating the anchor control handle 1004 to rotate the valve annulus anchor 800. The method may include independent rotation of the valve anchor 800 relative to the bushings 520, 620, 720. The method may include holding the bushings 520, 620, 720 stationary during rotation of the valve annulus anchor 800. The method may include the controlled release of the pocket-shaped drawstring suture 1010. Release may deploy the occlusion aids 500, 600, 700. The pocket-shaped drawstring suture 1010 may be disposed within and / or along the periphery of the occlusion aids 500, 600, 700. The pocket-shaped drawstring suture 1010 may facilitate the folding and / or deployment of the occlusion aids 500, 600, 700. The method may include rotating and adjusting the occlusion aids 500, 600, 700 so that the lower edges 580, 680, 780 or ventricular portions of the occlusion aids 500, 600, 700 are aligned with the valve openings. The method may include rotating and adjusting the occlusion aids 500, 600, 700 so that the lower edges 580, 680, 780 or ventricular portions are aligned around the posterior leaflet.

[0175] Figure 13 The illustration illustrates the recapture of the engagement aids 500, 600, and 700. The engagement aids 500, 600, and 700 can be recaptured by folding the engagement aids 500, 600, and 700 by tightening the drawstring-type stitch 1010 around a portion of the periphery 1620 of the engagement aids 500, 600, and 700. The periphery can include any edge, any combination of edges, or all edges described herein. The recapture sheath and transatrial septal sheath 1600 can advance over the folded engagement aids 500, 600, and 700. The petal-like recapture sheaths radiating from the central bushing can reverse the engagement aids 500, 600, and 700, causing them to retract into the transatrial septal sheath. The petal-shaped recapture sheath can be unscrewed or released, and the system can be removed. The engagement aids 500, 600, and 700, which recapture the prolapsed or partially encapsulated sheath petals, can be another delivery mode. This encapsulation-priority delivery mode can be contrasted with the bushing-priority and strut-priority delivery modes described herein.

[0176] In some methods, recapture is an optional method step. The method may include tightening the drawstring suture 1010. This tightening may fold the apical devices 500, 600, 700. The method may include advancing the recapture sheath and / or transseptal sheath over the folded apical devices 500, 600, 700. The recapture sheath may fold outward to flip the apical devices 500, 600, 700. The method may include retracting the apical devices 500, 600, 700 back into the transseptal sheath. The method may include rotating the annular anchor 800 to disengage from the tissue. The method may include removing the apical devices 500, 600, 700 and the annular anchor 800.

[0177] Figure 14 The illustration shows a cross-sectional view of deployed engagement aids 500, 600, and 700. The method may include the step of releasing the engagement aids 500, 600, and 700. The method may also include the step of retracting the delivery catheter 1000.

[0178] Figure 15 The illustration depicts the deployment of secondary anchors. In some methods, the deployment of secondary anchors is an optional method step. The method may include the step of engaging the annular attachment site to the annulus. The method may include the step of engaging ventricular anchors. The method may include the step of engaging commissural anchor 1800. The method may include the step of deploying markers at strategic locations on commissural aids 500, 600, 700 and / or annular anchor 800. The method may include the step of detecting markers, such as detecting radiopaque markers. The method may include the step of facilitating the placement of anchor 800 under fluoroscopy. The method may include the step of positioning radiopaque markers along the periphery of commissural aids 500, 600, 700 to indicate the shape of commissural aids 500, 600, 700.

[0179] In some implementations, the manufacturer provides instructions for use of the system that include one or more of the steps disclosed herein, or any steps previously described in the accompanying drawings or inherent therein.

[0180] It is anticipated that multiple combinations or sub-combinations of the specific features and aspects of the disclosed embodiments can be made, and said combinations or sub-combinations still fall within one or more of the inventions herein. Furthermore, any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc., disclosed herein can be used together with the embodiments in all other embodiments given herein. Therefore, it should be understood that various features and aspects of the disclosed embodiments can be combined or substituted with each other to form different ways of the disclosed invention. Therefore, the scope of the invention intended to be disclosed herein should not be limited to the specific disclosed embodiments above. Furthermore, although the invention is open to various modifications and alternative forms, specific examples of which have been shown in the drawings and described in detail herein, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any methods disclosed herein need not be performed in the order stated. The methods disclosed herein include certain actions taken by those skilled in the art; however, they may also explicitly or implicitly include any third-party instructions regarding those actions. For example, an action such as “inserting an occlusive device near the mitral valve” includes “instructing the insertion of an occlusive device near the mitral valve.” The scope disclosed herein also includes any or all overlaps, sub-scopes, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., includes the stated numbers. Numbers preceded by terms such as “approximately,” “about,” and “substantially” as used herein include the stated numbers and also indicate quantities close to the stated quantity that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” and “substantially” can refer to quantities within a range of less than 10% of the stated quantity, less than 5% of the stated quantity, less than 1% of the stated quantity, less than 0.1% of the stated quantity, or less than 0.01% of the stated quantity.

Claims

1. A system for treating malalignment of heart valves, the heart valves having annular rings, the system comprising: Matching auxiliary device, the matching auxiliary device comprising: The body includes an annular portion and an antagonistic portion, the annular portion being configured to be implanted in the heart above the valve annulus, and the antagonistic portion being configured to be implanted in the heart and to bisect the plane of the valve annulus. The first mating surface, and the opposite second surface; First side edge, second side edge, bottom edge, and top edge; An annular bushing extending upward from the annular portion, wherein the annular bushing is radially inwardly spaced from each of the first side edge, the second side edge, the lower edge, and the upper edge; and Multiple supports, the multiple supports extending radially outward from the annular bushing, The system also includes: A delivery conduit, wherein the delivery conduit is configured to couple with the annular bushing, wherein the annular bushing prevents the engagement aid from swaying when supported by the annular bushing; and An anchor, which is configured to attach the occlusion aid to the valve annulus or atrial wall.

2. The system of claim 1, wherein the anchor is configured to rotate relative to the annular bushing.

3. The system of claim 1, wherein the engagement aid is configured to deploy by causing the plurality of struts to extend radially outward from the annular bushing.

4. The system of claim 1, wherein the mating aid is configured to be suspended such that the first mating surface mates with the first leaflet, and the second surface of the mating aid covers the second leaflet to mitigate poor mating.

5. The system of claim 1, wherein one of the plurality of pillars of the engagement aid includes a pointed end configured to engage with cardiac tissue.

6. The system of claim 1, further comprising one or more markers configured to monitor the position of the engagement assist device.

7. The system of claim 1, further comprising one or more markers near the upper edge of the engagement assist device, the one or more markers being configured to monitor the position of the engagement assist device.

8. The system of claim 1, wherein the tip of the anchor is configured to be recessed into the annular bushing during the arrangement of the annular bushing near the valve ring.

9. The system of claim 1, wherein the occlusion aid and the delivery conduit are removably coupled such that the occlusion aid is configured to be released from the delivery conduit during the procedure.

10. The system of claim 1, further comprising one or more secondary structures, the one or more secondary structures including sutures.

11. The system of claim 1, wherein the coupling aid and the delivery conduit are rotated and fixed relative to each other when coupled.

12. The system of claim 1, wherein the relative movement of the delivery conduit causes movement of the engagement aid.

13. The system of claim 1, wherein the anchor is independently coupled to a portion of the delivery conduit.

14. The system of claim 1, further comprising a actuator disposed together with the delivery catheter.

15. The system of claim 1, wherein the anchor is independently coupled to a driver disposed together with the delivery conduit.

16. The system of claim 1, wherein the anchor is configured to be driven into the tissue while the delivery catheter holds the annular bushing in position.

17. The system of claim 1, wherein the delivery conduit is configured to allow the anchor to rotate independently of the annular bushing.

18. The system of claim 1, wherein the annular bushing is configured to remain fixed when the anchor is rotated to engage the tissue.

19. The system of claim 1, wherein the mate assist device is configured to unfold and / or fold through the delivery conduit.

20. The system of claim 1, wherein the delivery catheter includes a tip deflection control.

21. The system of claim 1, wherein the delivery conduit includes one or more ports.

22. The system of claim 1, wherein the delivery catheter includes an implant control handle.

23. The system of claim 1, wherein the delivery conduit includes an anchor control handle.

24. The system of claim 1, wherein the delivery catheter is configured to lock onto the annular bushing such that movement of the delivery catheter causes movement of the engagement aid.

25. The system of claim 1, further comprising a release mechanism between the delivery catheter and the annular bushing.

26. The system of claim 1, further comprising a drive configured to engage the anchor to deliver torque.

27. The system of claim 1, further comprising one or more additional anchors.

28. The system of claim 1, further comprising a non-transmissive marker.

29. The system of claim 1, wherein the anchor is configured to rotate relative to the annular bushing to selectively deploy the anchor at a first target location.

30. The system of claim 1, wherein the annular bushing is tubular.

31. The system of claim 1, wherein the annular bushing and the plurality of pillars are integrally formed.

32. The system of claim 1, further comprising a cover covering a portion of the plurality of pillars of the engagement aid.

33. The system of claim 1, wherein the plurality of pillars comprises nitinol.

34. The system of claim 1, further comprising a suture, wherein the suture is configured to fold the folding aid.

35. The system of claim 1, wherein the annular bushing is configured to extend the valve annulus remotely from the heart valve.

36. The system of claim 1, wherein one or more of the plurality of struts have one end terminating at the annular bushing and another end extending radially outward toward one of a first side edge, a second side edge, a lower edge, or an upper edge.

37. The system of claim 1, wherein the ventricular end of the occlusion assist device is configured to remain within the delivery catheter until the annular bushing is arranged.

38. The system of claim 1, wherein the tip of the anchor is configured to remain recessed within the annular bushing until the anchor is rotated to engage the tissue.

39. The system of claim 1, wherein the delivery catheter includes a tip deflection control, wherein the tip deflection control is configured to deflect a distal portion of the delivery catheter.

40. The system of claim 1, wherein the annular bushing includes a portion around which the helical structure of the anchor is wound.

41. The system of claim 1, wherein the anchor is configured to be pre-loaded onto the engagement aid and coupled to the driver during the process of installing the engagement aid onto the delivery conduit.

42. The system of claim 1, wherein the anchor is an anchor captured within the annular bushing.

43. The system of claim 1, wherein the plurality of pillars are spaced apart at regular intervals.

44. The system of claim 1, wherein the occlusion assist device is configured to move along the blood flow path as the heart valve moves back and forth between an open valve configuration and a closed valve configuration.

45. The system of claim 1, wherein the engagement aid is configured not to be attached near the lower edge.

46. ​​The system of claim 1, wherein the annular bushing is located near the midpoint of the annular portion of the mating aid.

47. The system of claim 1, wherein the annular bushing is located near the midpoint of the diameter of the mating auxiliary device.

48. The system of claim 1, wherein the annular bushing includes features that engage the delivery catheter.

49. The system of claim 1, wherein two of the plurality of pillars have different lengths.

50. The system of claim 1, wherein at least one of the plurality of pillars is forked.

51. The system of claim 1, wherein at least one of the plurality of supports includes an eyelet.

52. The system of claim 1, wherein at least one of the plurality of supports comprises a barb.

53. The system of claim 1, wherein at least one of the plurality of pillars includes a zigzag portion configured to increase the flexibility of the pillar.

54. The system of claim 1, further comprising a layer of covering, wherein the plurality of pillars are sandwiched between the layers of covering.

55. The system of claim 1, wherein the plurality of pillars includes at least a first pillar having one end terminating at the annular bushing and another end extending radially outward.

56. The system of claim 1, wherein at least one of the plurality of supports comprises a barb, wherein the barb comprises a sharp tip.

57. The system of claim 1, wherein the delivery catheter is configured to recapture the occlusion aid.

58. The system of claim 1, wherein the engagement aid only requires valve ring attachment.

59. A system comprising: Matching auxiliary device, the matching auxiliary device comprising: The body includes an annular portion and an opposing portion, the annular portion being configured to be implanted in the heart above the valve annulus, and the opposing portion being configured to be implanted in the heart and to bisect the plane of the valve annulus. The first mating surface, and the opposite second surface; First side edge, second side edge, bottom edge, and top edge; and An annular bushing extends upward from the annular portion, wherein the annular bushing is located at a central position on the engagement aid, wherein the central position enhances the stability of the engagement aid when the engagement aid is gripped in a single position, wherein the annular bushing is radially inwardly spaced from each of the first side edge, the second side edge, the lower edge, and the upper edge. and Multiple supports, the multiple supports extending radially outward from the annular bushing, The system also includes: An anchor, which is configured to attach the occlusion aid to the valve annulus or atrial wall.

60. The system of claim 59, wherein the plurality of pillars are configured to maintain the shape of the engagement aid.

61. The system of claim 59, further comprising one or more markers.

62. The system of claim 59, further comprising one or more markers near the upper edge of the engagement aid.

63. The system of claim 59, wherein the tip of the anchor is configured to be recessed into the annular bushing.

64. The system of claim 59, further comprising a secondary structure including sutures.

65. The system of claim 59, further comprising one or more additional anchors.

66. The system of claim 59, further comprising a non-transmissive marker.

67. The system of claim 59, wherein the annular bushing extends upward from the annular portion.

68. The system of claim 59, wherein the anchor is configured to rotate relative to the annular bushing.

69. The system of claim 59, wherein the annular bushing is tubular.

70. The system of claim 59, wherein the annular bushing and the plurality of pillars are integrally formed.

71. The system of claim 59, further comprising a covering that covers a portion of the plurality of pillars.

72. The system of claim 59, further comprising a covering comprising ePTFE.

73. The system of claim 59, further comprising a cover comprising polyester.

74. The system of claim 59, further comprising a covering comprising polyurethane foam.

75. The system of claim 59, further comprising a covering comprising polycarbonate foam.

76. The system of claim 59, further comprising a covering comprising silicone.

77. The system of claim 59, further comprising a cover comprising polyester.

78. The system of claim 59, wherein the plurality of pillars comprises nitinol.

79. The system of claim 59, wherein the annular bushing is configured to extend the valve annulus remotely from the heart valve.

80. The system of claim 59, wherein the annular bushing and the plurality of supports are formed of tubing.

81. The system of claim 59, wherein two of the plurality of pillars have different lengths.

82. The system of claim 59, wherein at least one of the plurality of pillars is bifurcated.

83. The system of claim 59, wherein at least one of the plurality of pillars includes an eyelet.

84. The system of claim 59, wherein at least one of the plurality of supports comprises a barb.

85. The system of claim 59, wherein at least one of the plurality of pillars includes a zigzag portion configured to increase the flexibility of the pillar.

86. The system of claim 59, further comprising a layer of covering, wherein the plurality of pillars are sandwiched between the layers of covering.

87. The system of claim 59, wherein the plurality of pillars maintain the shape of the engagement aid.

88. The system of claim 59, wherein the intermediate position is the central position on the annular portion.

89. The system of claim 59, wherein the intermediate position is between the side edges.

90. The system of claim 59, wherein the intermediate position is between the upper edge and the mating surface.

91. The system of claim 59, wherein the single location is the annular bushing.

Images