A system for repairing a heart valve

Abstract

Systems (100) and methods are provided for adjustable and removable implants (102) to repair heart valves such as the mitral, tricuspid or aortic valves. The implants (102) are capable of being delivered to the heart in a simple and non-invasive manner through the apex of the heart. The implants include a prosthetic valve portion (106) coupled to a proximal end of a shaft and an anchoring portion (110) coupled to a distal end of the shaft. The prosthetic valve is suspended within the opening of the heart valve while the anchoring portion is secured to the apex of the heart. Upon deployment of the implant, the distance between the prosthetic valve portion and the anchoring portion can be adjusted and / or the implant and / or portions thereof can be rotated to in turn change the position of the prosthetic valve within the heart valve. This can be done to correct for migration of the implant after implantation, mitigating potential complications.

Description

[0001] Case Analysis

[0002] This application is a divisional application of Chinese invention patent application CN201480063220.7, filed on November 20, 2014, entitled "Adjustable Heart Valve Implant". Technical Field

[0003] Systems and methods for repairing heart valves using adjustable heart valve implants are provided. Background Technology

[0004] The human heart is a vital part of the body, containing four chambers: the left and right atria and the left and right ventricles. These chambers alternately expand and contract to pump blood through the body. Each chamber contains valves, which, when functioning normally, control blood flow in only one direction. However, heart valves can become diseased or develop other defects that prevent them from closing properly when the lower chamber contracts.

[0005] Mitral regurgitation is a mitral valve failure in which the mitral valve, which separates the left atrium and left ventricle, fails to close properly when the heart pumps blood. Therefore, when the left ventricle contracts, blood leaks abnormally (flows back) from the left ventricle into the left atrium instead of flowing normally into the aorta. Mitral regurgitation causes the left ventricle to enlarge, which, if left untreated, can eventually lead to potentially fatal arrhythmias and heart failure.

[0006] Another common heart condition is aortic valve failure, such as aortic stenosis, where the aortic valve, located between the left ventricle and atrium, becomes abnormally narrow or restricted (stenotic) and therefore cannot open fully. This reduces blood flow from the heart and can lead to serious cardiac complications.

[0007] Heart valve regurgitation and other valvular heart diseases can be caused by a variety of conditions and often require surgical intervention, including natural heart valve replacement or heart replacement. Currently, open-heart surgery is commonly performed to surgically repair or replace diseased or defective heart valves using, for example, artificial heart valves. However, open-heart surgery carries significant risks and can lead to numerous complications. Furthermore, some patients (such as children, the elderly, and those with chronic diseases) are at particular risk for open-heart surgery and cannot be treated with this method.

[0008] More recent methods have been developed to avoid invasive valve repair or replacement surgery by delivering artificial valves via catheters. However, natural heart valves, such as the mitral valve, have complex anatomy and deform in complex ways with heart rhythm. Existing methods cannot accurately mimic the function of the mitral valve and cannot address potential problems such as tissue damage, cardiac remodeling, and paravalvular leaks. Furthermore, currently developed techniques do not provide an appropriate means of replacing heart valve implants after they have deployed.

[0009] Therefore, there remains a need for improved methods and systems for non-invasive delivery of artificial heart valves. Summary of the Invention

[0010] A method for repairing the mitral valve is provided, which in some embodiments includes pushing the outer shaft of a guide assembly through the apex into the left atrium of the heart; deploying the artificial valve portion of the implant from the outer shaft in the left atrium such that the artificial valve portion moves from a non-expanding configuration to an expanding configuration, and arranging at least one locating element of the artificial valve portion on opposite sides of the mitral valve orifice to suspend the artificial valve portion within the mitral valve orifice; retracting the outer shaft from the left atrium toward the apex such that at least a portion of the inner shaft of the guide assembly and the implant anchor portion is exposed; and deploying proximal and distal deployable wings on the anchor portion to engage the tissue between them thereby removably securing the anchor portion to the apex. The outer shaft is advanced through the apex into the left atrium via a tip of the guide assembly directly puncturing the apex. Removably securing the anchor portion to the apex creates closure of the apical perforation.

[0011] This method can be modified in various ways. In some embodiments, the inner shaft may include an adjustable tether configured to attach the artificial valve portion to the anchorage portion. The tether is attached to the anchorage portion using a tether lock. Before attaching the tether to the anchorage portion using the tether lock, a portion of the tether can retract proximally to the proximal end of the anchorage portion. In some embodiments, the tether lock may be recessed within the body of the anchorage portion so as not to protrude into the pericardial cavity. In some embodiments, the tether may be formed of absorbable or non-absorbable sutures. In other embodiments, the tether may include cable sutures (e.g., metallic sutures), or it may be formed of any other material. The tether may have one or more portions.

[0012] The method also includes adjusting the distance between the prosthetic valve portion and the anchor portion of the implant. In some embodiments, this distance is adjusted using an adjustable tether that connects the prosthetic valve to the anchor portion. The method also includes accessing the proximal end of the anchor portion via an adjustment tool and adjusting the distance using the adjustment tool. The proximal end of the anchor portion can be accessed percutaneously. The distance can be adjusted by retracting an inner shaft about the anchor portion. The length of the inner shaft can be adjusted before the anchor portion is secured within the apex of the heart.

[0013] In some embodiments, the method further includes rotating a portion of the artificial valve portion suspended within the mitral valve orifice. The method also additionally or alternatively includes rotating the implant while the artificial valve portion is suspended within the mitral valve orifice. The method further includes removing the external shaft.

[0014] In some embodiments, deploying the artificial valve portion includes deploying the artificial valve portion from the outer shaft in the left atrium, and subsequently retracting the outer shaft from the left atrium to engage at least one positioning element with the mitral valve.

[0015] The artificial valve portion of the implant can have many variations. For example, in some embodiments, the artificial valve portion includes an expandable frame, and at least one positioning element includes an expandable ring circumferentially disposed at the end of the expandable frame. The method can include adjusting the diameter of the expandable frame after the artificial valve portion is deployed. In embodiments where the inner shaft includes an adjustable tether, the diameter of the expandable frame can be adjusted by adjusting the length of the tether or otherwise manipulating the tether.

[0016] In some embodiments, the method further includes using at least one radiopaque marker associated with the artificial valve portion to determine the location of the artificial valve portion.

[0017] The proximal and distal deployable wings can vary in any manner. For example, in some embodiments, the proximal and distal deployable wings can deploy within the tissue at the apex of the heart. In other embodiments, the proximal and distal deployable wings can deploy on the opposite side of the apical wall. In some embodiments, deployment of the proximal and distal deployable wings includes deploying the distal wing and, after the distal wing has deployed, retracting the outer shaft proximally away from the artificial valve body to deploy the proximal wing. In some embodiments, the distal wing can deploy against the apical wall and the proximal wing can deploy within the tissue. In other embodiments, the proximal wing can deploy against the apical wall and the distal wing can deploy within the tissue.

[0018] In some embodiments, the method further includes engaging the proximal end of the anchor portion with an actuator tool, deploying the actuator tool to move the proximal and distal wings from an expanded configuration to a non-expanded configuration, advancing the guide assembly toward the prosthetic valve portion on the actuator tool, deploying the actuator tool to move the prosthetic valve portion from an expanded configuration to a non-expanded configuration, and removing the prosthetic valve portion in the non-expanded configuration from the left atrium via the guide assembly. The method may also include, after removing the prosthetic valve portion from the guide sheath, retracting the guide assembly toward the apex, inserting a second closure device into the sheath, and deploying the second proximal and distal wings of the second closure device to engage the tissue between them at a perforation at the apex.

[0019] In other aspects, methods for repairing heart valves are provided, wherein in some embodiments, the method includes delivering an outer shaft of a guide assembly through the apex of the heart into the atrium of the heart; deploying an artificial valve from the outer shaft in the atrium such that the artificial valve moves from a non-expanded configuration to an expanded configuration and at least one locating element of the artificial valve is arranged over the opening of the heart valve to suspend the body of the artificial valve within the opening; retracting the outer shaft from the atrium toward the apex such that a suture tether or inner shaft connected to the artificial valve and extending between the artificial valve and an anchor is exposed; removably securing the anchor to the apex; and adjusting the distance between the artificial valve and the anchor.

[0020] This method can be modified in various ways. For example, in some embodiments, the inner shaft includes an adjustable tether, such as a flexible suture tether. In such embodiments, the distance between the artificial valve and the anchor can be adjusted by changing the length of the tether. For example, the tether can be retracted proximally.

[0021] In some embodiments, the method further includes removing the outer shaft through the apex of the heart. In some embodiments, the distance between the artificial valve and the anchor can be adjusted after the anchor is secured to the apex. Removably securing the anchor to the apex can include deploying the proximal and distal deployable wings of the anchor to engage the tissue between them.

[0022] The method can also include rotating the body of the artificial valve within the opening of the heart valve. The heart valve can include the mitral valve, and the atrium can include the left atrium. The method also includes removing the artificial valve from the atrium via an external shaft.

[0023] On one hand, the present invention provides a system for repairing a heart valve, which in some embodiments includes: an outer shaft; and an implant disposed within the outer shaft, the implant comprising: an inner shaft including at least one tether; an artificial valve connected to a distal end of the inner shaft and having an artificial valve body and at least one positioning element, the artificial valve being configured to advance distally from the outer shaft such that the artificial valve moves from a non-expanded configuration state; at least one positioning element being configured to suspend the artificial valve within an opening in tissue; and an anchoring portion configured to be removably secured to tissue, the anchoring portion having a distal end connected to a proximal end of the inner shaft and a tether locking portion fixedly connected to the proximal end of the anchoring portion, the tether locking portion including a locking mechanism configured to reversibly lock at least one tether; wherein at least one tether is configured to selectively move relative to the anchoring portion and the tether locking portion such that, when the tether locking portion is unlocked, the length of at least one tether is adjusted by releasing or contracting at least one tether to increase or decrease the distance between the artificial valve and the anchoring portion.

[0024] The system can vary in several ways. For example, in some embodiments, the artificial valve body includes an artificial valve leaflet, and at least one positioning element is capable of including at least two arms connected to the valve body. In other embodiments, the artificial valve body may include an expandable frame, and the at least one positioning element may include an expandable ring circumferentially arranged at the distal end of the expandable frame.

[0025] The anchoring portion can vary in many ways. For example, the anchoring portion includes proximal and distal deployable wings configured to engage the structure between them.

[0026] On the other hand, the present invention provides a system for repairing a heart valve, which in some embodiments includes an outer shaft; and an implant disposed within the outer shaft, the implant comprising: an inner shaft; an artificial valve connected to the distal end of the inner shaft and having an artificial valve body and at least one positioning element, the artificial valve being configured to advance distally from the outer shaft such that the artificial valve moves from a non-expanding configuration state; at least one positioning element being configured to suspend the artificial valve within an opening in tissue; an anchoring portion connected to the proximal end of the inner shaft and configured to be removably secured to tissue, the anchoring portion having a proximal deployable wing and a distal deployable wing engaging tissue therebetween; and a locking portion fixedly connected to the proximal end of the anchoring portion, the locking portion having a locking mechanism configured to reversibly lock the inner shaft; wherein the anchoring portion is configured to releasably engage with an adjustment tool to manipulate the anchoring portion to expand the proximal and distal deployable wing portions, and wherein the locking portion is configured to releasably engage with the adjustment tool to adjust the length of the inner shaft to increase or decrease the distance between the artificial valve and the anchoring portion.

[0027] The system can be varied in several ways. For example, the one or more tethers can be flexible tethers. Flexible tethers can be formed from sutures. In some embodiments, the artificial valve body includes artificial valve leaflets, and the at least one positioning element can include at least two arms connected to the valve body. In other embodiments, the artificial valve body includes an expandable frame, and the at least one positioning element can include an expandable ring circumferentially arranged at the distal end of the expandable frame.

[0028] The anchoring portion can vary in many ways. For example, the anchoring portion includes proximal and distal deployable wings configured to engage the structure between them. Attached Figure Description

[0029] The embodiments described above will be more fully understood through the following detailed description and in conjunction with the accompanying drawings. The drawings are not drawn to scale. For clarity, not every component is labeled in every drawing. In the drawings:

[0030] Figure 1A This is a side view of an implant according to some embodiments, having an unexpanded artificial valve portion;

[0031] Figure 1B It has extended proximal and distal wings. Figure 1A Side view of the implant;

[0032] Figure 2A It is an artificial valve with an expansion configuration. Figure 1A and 1B Side view of the implant;

[0033] Figure 2B It has extended proximal and distal wings. Figure 2A Side view of the implant;

[0034] Figure 3 This is a schematic diagram of an enlarged view of an artificial valve according to some embodiments;

[0035] Figure 4A This is a side view of an implant according to some embodiments;

[0036] Figure 4B yes Figure 4A Side view of the implant;

[0037] Figure 4C yes Figure 4A A side perspective view of the implant, showing the implant connected to an actuator tool according to some embodiments;

[0038] Figure 5A yes Figure 4A A side-view perspective view of the implant, showing the deployable wings;

[0039] Figure 5B yes Figure 4A A perspective view of the other side of the implant, showing the deployable wings;

[0040] Figure 5C This is a side view of an implant according to some embodiments, having an artificial valve portion in an unexpanded configuration and expanded proximal and distal wings;

[0041] Figure 5D yes Figure 5C Another view of the implant;

[0042] Figure 5E It is an artificial valve with an expansion configuration. Figure 5C Another view of the implant;

[0043] Figure 5F yes Figure 5E A side view of the implant, showing the extended proximal and distal wings;

[0044] Figure 5G This is a side view of another implant according to some embodiments;

[0045] Figure 5H This is a side view of another implant according to some embodiments;

[0046] Figure 6A This is a cross-sectional view of the heart illustrating a method of delivering and deploying an implant according to some embodiments;

[0047] Figure 6B This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0048] Figure 6C This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0049] Figure 6D This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0050] Figure 6E This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0051] Figure 6F This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0052] Figure 6G This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0053] Figure 6H This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0054] Figure 6I This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0055] Figure 6J This is another cardiac sectional view illustrating a method of delivering and deploying an implant according to some embodiments;

[0056] Figure 7A This illustrates the adjustment according to some embodiments, such as Figure 6A-6J A sectional view of the heart showing the method of unfolding the implant;

[0057] Figure 7B This illustrates the adjustment according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0058] Figure 8A This illustrates the removal of, according to some embodiments, such as Figure 6A-6JA sectional view of the heart showing the method of unfolding the implant;

[0059] Figure 8B This illustrates the removal of, according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0060] Figure 8C This illustrates the removal of, according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0061] Figure 8D This illustrates the removal of, according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0062] Figure 8E This illustrates the removal of, according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0063] Figure 8F This illustrates the removal of, according to some embodiments, such as Figure 6A-6J Another cardiac cross-section view of the method of unfolding the implant shown in the image;

[0064] Figure 9A This is a cross-sectional view of the heart illustrating a method for implanting a sealing implant according to some embodiments;

[0065] Figure 9B This is another cardiac sectional view illustrating a method for sealing an implantation site according to some embodiments;

[0066] Figure 9C This is another cardiac sectional view illustrating a method for sealing an implantation site according to some embodiments;

[0067] Figure 9D This is another cardiac sectional view illustrating a method for sealing an implantation site according to some embodiments;

[0068] Figure 9E This is another cardiac sectional view illustrating a method for implanting a sealing implant at the implantation site according to some embodiments; and

[0069] Figure 10 It has been expanded according to some embodiments. Figure 4A , 4B Heart sectional views of implants 4C, 5A, and 5B. Specific Implementation

[0070] Some exemplary embodiments will now be described to provide an overall understanding of the principles of the apparatuses and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of the invention is defined only by the claims. Furthermore, features shown or described with respect to one exemplary embodiment may be combined with features of other embodiments. These modifications and variations should be included within the scope of the invention.

[0071] Methods and apparatus for repairing and replacing heart valves are provided. In particular, the described technique utilizes a system for delivering an adjustable implant into a heart valve, the adjustable implant comprising an artificial valve portion and an anchoring portion, the artificial valve portion being configured to be positioned within the orifice of a natural heart valve such as the mitral, tricuspid, or aortic valve, and the anchoring portion being configured to secure the implant to the apex of the heart. The artificial valve may have a configuration that allows it to be removably suspended within the orifice of a diseased or defective heart valve, enabling the artificial valve to repair the abnormality of the heart valve or completely replace the diseased valve.

[0072] In some exemplary methods, the implant can be delivered to the heart valve via the apex of the heart. This transapex delivery allows for minimally invasive delivery of the implant, such as percutaneously, which may allow for treatment of high-risk patients. In some cases, even a relatively non-invasive minor open-chest surgery can be avoided. No additional sutures (e.g., purse-string sutures) are required to place the implant at the apex, which reduces trauma to cardiac tissue and thus reduces the risk of complications.

[0073] Furthermore, the distance between the prosthetic valve portion and the anchoring portion can be adjusted after the implant has deployed within the heart. In some embodiments, the implant or a portion thereof can be rotated. This adjustment can be performed non-invasively or minimally invasively and can allow for the reduction or elimination of potential post-implantation complications, such as paravalvular leak, cardiac remodeling (undesirable changes in tissue structure), and other underlying diseases, without removing the implant from the implantation site. The deployed implant can be moved to an undeployed configuration and easily removed from the implantation site. Therefore, the implant placement procedure according to the described embodiments can be simple, repeatable, cost-effective, and causes minimal discomfort to the patient.

[0074] Figure 1A and Figure 1B A system 100 for repairing a heart valve is illustrated according to one embodiment. The system 100 may include an implant 102 and an external shaft 104 defining a lumen extending therefrom, the lumen being configured to slidably receive the implant 102 therein. The external shaft 104 may be a component configured to deliver the implant 102 to a guide assembly within the heart. The external shaft 104 in… Figure 1A The external shaft 104 is shown as a component separate from the implant 102 by way of example, to illustrate that it is configured to removably receive the implant 102. The external shaft 104 may be an elongated tubular member configured to pass through the apex of the heart and be inserted into the heart.

[0075] like Figure 1A As shown, the implant 102 may include an artificial valve portion 106, an inner shaft 108, and an anchoring portion 110. The artificial valve portion 106 is capable of being connected at its proximal end 105 to the distal end 112 of the inner shaft 108, and the anchoring portion 110 is capable of being connected to the proximal end 114 of the inner shaft 108. As used herein, the term "proximal" or "part" refers to the end or part closest to (e.g., using a suitable actuator tool) the person operating the outer shaft 106, and the term "distal" or "part" refers to the end or part closer to the front end 103 of the implant 102.

[0076] In the illustrated embodiment, the inner shaft 108 may have a distal portion, a middle portion, and proximal portions 116, 118, 120, which may be configured to slidably and fixedly engage with each other. For example, at least a portion of the distal portion 116 may be configured to be slidably received within the middle portion 118. In some embodiments, as discussed in more detail below, the inner shaft 108 may be formed of absorbable or non-absorbable sutures extending between the artificial valve portion 106 and the anchor portion 110. The sutures may also extend through the anchor portion 110. In some embodiments, at least a portion of the middle portion 118 of the inner shaft 108 may be configured to be slidably received within the proximal portion 120. This allows adjustment of the distance between the distal and proximal ends 112, 114 of the inner shaft. A threaded mechanism or any other suitable mechanism may be used to adjust the length of the inner shaft. The proximal portion 120 of the inner shaft 108 is configured such that the inner surface of the inner shaft 108 mates with a suitable tool that can be manipulated to adjust the length of the inner shaft 108.

[0077] In some embodiments, the diameter of the proximal portion 120 is larger than the diameter of the distal and intermediate portions 116, 118. The distal and intermediate portions 116, 118 have diameters suitable for implantation into the heart chamber. The anchor portion 110 can be sized to close a hole or perforation in the apex of the heart. In the illustrated embodiment, the proximal portion 120 mates with the anchor portion 110 and is the same as or similar in size (e.g., diameter) to the anchor portion 110. However, in other embodiments, the diameter of the proximal portion 120 may be smaller than the diameter of the anchor portion 110. The distal, intermediate, and proximal portions 116, 118, 120 have any suitable length. In some embodiments, one or more portions of the inner shaft 108 are rotatable relative to other portions. For example, the distal and intermediate portions 116, 118 may be configured to rotate relative to the proximal portion 120. This allows the implant 102 to be adjusted by rotating the artificial valve 106 or the entire implant 102 after it has been deployed. Those skilled in the art will understand that the inner shaft 108 can have various configurations and can include any number of components, as the embodiments described herein are not limited thereto.

[0078] Anchoring parts, configured as sealing devices to close holes or perforations in tissues, can also have various configurations. For example... Figure 1A As shown, the anchoring portion 110 may include a distal portion, a middle portion, and proximal portions 122, 124, and 126. The distal portion 122 of the anchoring portion 110 may be connected to the proximal end 114 of the inner shaft 108. The distal and proximal portions 122 and 126 of the anchoring portion 110 may be configured to expand to form Figure 1B The deployable wings 128 and 130 are shown. The deployed wings 128 and 130 can remain in an expanded configuration until the anchor 110 is actuated to retract the wings 128 and 130 into a non-expanded configuration. It should be understood that the implant 102 may include any other components not shown herein configured such that the anchor 110 can reversibly form the wings 128 and 130.

[0079] In some embodiments, which will be described in more detail below, the inner shaft 108 includes one or more adjustable tethers (e.g., sutures or suture-like tethers) extending between the artificial valve portion and the anchoring portion. In this embodiment, the implant 102 may additionally or alternatively include components for providing a tether lock or tether clip. The lock is designed to reversibly attach one or more tethers to the implant 102 after tether length adjustment.

[0080] In some embodiments, the implant 102 may include components configured as described in the following documents: U.S. Patent No. 7,625,392 entitled “Wound Closure Devices and Methods”, issued December 1, 2009; U.S. Patent No. 8,197,498 entitled “Gastric Bypass Devices and Procedures”, issued June 12, 2012; U.S. Patent Application Publication No. 2009 / 0105733 entitled “Anastomosis Devices and Methods”, filed October 22, 2007; and U.S. Patent Application Publication No. 2013 / 0165963 entitled “Devices and Methods for Occluding or Promoting Fluid Flow”, filed December 21, 2011, the entire contents of each of which are incorporated herein by reference.

[0081] The artificial valve portion 106 can also have various configurations that allow it to be inserted into the heart via the external shaft 104. For example, the artificial valve 106 is configured such that it can move between an undilated configuration and an dilated configuration. Figure 1A and 1B In the image, the artificial valve portion 106 is shown in an unexpanded configuration.

[0082] An embodiment of the artificial valve portion 106 in an expanded configuration is described in... Figure 2A and 2B This is shown in more detail below. Figure 2A Implant 102 is shown, in which wings 128 and 130 are not deployed, while Figure 2B An example of the wings 128, 130 of the implant 102 deployed is shown. Figure 2B As schematically shown, the proximal end 132 of the anchor 110 can be configured to engage with an actuator tool 134 for manipulating the inner shaft 108 to adjust its length. The same or another tool can be configured to engage with the anchor 110 via the proximal end 132 to deploy the wings 128, 130. Furthermore, a suitable actuator tool can engage with the anchor 110 to cause the deployed wings 128, 130 to return to their undeployed configuration.

[0083] In some embodiments, the artificial valve portion includes an artificial valve body and at least one positioning element configured to suspend the artificial valve portion within the opening of the heart valve. For example... Figure 2A and 2BAs shown, the artificial valve portion 106 may include a valve body 202 and positioning elements 204A, 204B connected to the valve body. In this example, the positioning elements 204A, 204B are in the form of positioning arms extending in opposite directions from the valve body 202. The artificial valve portion 106 may also include a valve shaft 207 extending between the proximal end 105 of the artificial valve portion 106 and the distal end 103 of the implant 102.

[0084] like Figure 3 The diagram shows an enlarged view of the artificial valve body 106. The valve body 202 may include a ridge 205 connected to the distal end 112 of the inner shaft 108 and leaflets 206A, 206B hinged to the ridge 205. The leaflets 206A, 206B are flexibly connected to the ridge 205 so that they can pivot or flip relative to the ridge 205 during cardiac contraction and relaxation. In some embodiments, the leaflets 206A, 206B can be brought together at one end to form the ridge, allowing the opposite ends of the leaflets to be configured to pivot or flip relative to the ridge. The leaflets 206A, 206B have any suitable size that allows them to mimic the function of a natural heart valve. The resilient leaflets 206A, 206B may be made of any suitable biological or synthetic material, or a combination thereof.

[0085] When the artificial valve portion 106 is deployed within the heart, it can move from a non-expanding configuration to an expanded configuration. In some embodiments, the valve body 202, having positioning elements 204A, 204B and leaflets 206A, 206B connected to them, can slide on the valve shaft 207, allowing the positioning elements 204A, 204B and leaflets 206A, 206B to fold and unfold in an umbrella-like manner. For example, in the non-expanding configuration, the member 212 disposed at the proximal end 105 of the artificial valve portion 106 can be pushed in any suitable manner (e.g., by an external shaft for inserting the implant into the implantation site, as discussed below), which can cause the leaflets 206A, 206B and positioning elements 204A, 204B to move outward and thus unfold. Similarly, when the artificial valve portion 106 is in the expanded configuration, depending on the configuration of the component 212, the component 212 can be pushed or otherwise actuated (e.g., pulled) to cause the positioning elements 204A, 204B and the leaflets 206A, 206B to move inward and fold.

[0086] The artificial valve portion 106 is used to alleviate the abnormalities of a diseased heart valve and / or to replace the natural heart valve entirely by mimicking its function. For example, when repairing a diseased mitral valve using implant 102, the leaflets 206A and 206B can be separated relative to the longitudinal axis B 209 of implant 102 due to left ventricular contraction (ejecting oxygen-rich blood throughout the body) and the closure of the healthy mitral valve, ensuring proper closure of the diseased mitral valve and preventing unintended backflow of blood into the left atrium. During left ventricular diastole and mitral valve opening to allow blood to flow from the left atrium to the left ventricle, the leaflets 206A and 206B remain closed together without interfering with blood flow.

[0087] Positioning elements 204A and 204B can be connected to the spine 205. For example, in some embodiments, positioning elements 204A and 204B may be integrally formed with the spine 205. However, it should be understood that positioning elements 204A and 204B can be connected to the spine 205 or other portions of the artificial valve portion 106 in any suitable manner, as the embodiments are not limited thereto.

[0088] Positioning elements 204A and 204B can be configured in any suitable way. For example, positioning elements 204A and 204B are formed of one or more elongated cables having a shape that allows positioning elements 204A and 204B to hold the artificial valve portion 106 within the mitral valve. In one embodiment, such as Figure 3 As shown, each positioning element 204A, 204B may form a shoulder having a straight or flat portion (302A, 302B) extending from and connecting to the spine 205, and a curved portion (304A, 304B) connecting to the flat portion (302A, 302B). The straight or flat portions 302A, 302B can be formed from separate cables or other elements, or in some cases, they can be formed from the same element (e.g., cable or other material). Each of the portions 302A, 302B can be connected to the spine 205 at the aforementioned portion 208, as... Figure 3 As shown in the figure. It should be understood that the parts 302A and 302B are not necessarily straight or flat along their entire length, but can have other suitable shapes.

[0089] exist Figure 3 In the example shown, bends 304A and 304B may be semi-U-shaped portions, which are connected to portions 302A and 302B at the top of the "semi-U" formed by bends 304A and 304B. In some embodiments, bends 304A and 304B are integrally formed with flat portions 302A and 302B. Figure 3Bends 304A and 304B are shown, which bend outward away from the longitudinal axis B 209 of the implant 102. However, other configurations of bends 304A and 304B may also be used. Positioning members 204A and 204B, or components thereof (e.g., bends 304A and 304B), are at least partially bendable to accommodate the anatomical features of the heart valve annulus, and positioning members 204A and 204B are configured to engage the heart valve annulus. The lengths of positioning members 204A and 204B correspond to the diameter of the heart valve annulus such that members 204A and 204B extend beyond the valve opening.

[0090] In some embodiments, the positioning elements 204A, 204B may have suitable structures configured to allow engagement of tissue above the heart valve opening. However, regardless of the specific configuration of the positioning elements 204A, 204B, they may be configured to engage tissue in a non-invasive manner to reduce or eliminate damage to the tissue.

[0091] like Figure 3 As shown, when the artificial valve portion 106 is in the deployed position, the positioning members 204A and 204B can be configured along a longitudinal axis A that is perpendicular to or substantially perpendicular to the ridge 205. Figure 3 The axis (indicated by numeral 203) extends in the opposite direction from the portion 208 of the ridge 205. It should be understood that the positioning elements 204A and 204B have any suitable configuration that allows them to suspend the artificial valve portion 106 within the heart valve, while... Figure 2A , 2B and Figure 3 The shapes of the positioning elements 204A and 204B are shown only as examples. Furthermore, in some embodiments, the artificial valve portion may include more than two positioning elements with any suitable configuration. For example, in some embodiments, additional positioning elements similar to elements 204A and 204B can extend from the ridge 205 at an angle different from that of elements 204A and 204B in the same plane as elements 204A and 204B. Additionally, in some embodiments, a single positioning element is used.

[0092] Regardless of the specific configuration of the positioning elements 204A and 204B and how they are connected to the ridge 205, the positioning elements 204A and 204B are foldably connected to the ridge 205, so that when the artificial valve portion 106 moves from a non-expanding configuration to an expanding configuration (e.g., when the implant 102 is deployed), the positioning elements 204A and 204B can expand to extend on opposite sides of the valve body 202, such as... Figure 2A , Figure 2B and Figure 3 As shown. When the artificial valve portion 106 moves from an expanded configuration to a non-expanded configuration (e.g., when the implant 102 retracts for subsequent removal from the implantation site), as... Figure 1A and1B As shown, positioning elements 204A and 204B are foldable such that they extend along the sides of leaflets 206A and 206B, which can also be configured to fold in a non-expanded position. In some embodiments, one or more portions of the artificial valve portion 106 are stretchable such that the artificial valve portion 106 in an expanded configuration can fold like an umbrella when pulled proximally.

[0093] In some embodiments, the implant (e.g., one or more positioning elements and / or other components of the implant) has one or more associated markings that can be used to non-invasively determine the location of the artificial valve portion within the heart. The markings are used to ensure accurate positioning of the artificial valve portion during delivery to the heart and during adjustment of the position of the artificial valve portion or the entire implant. The markings can be radiopaque elements (e.g., made of platinum, gold, silver, tungsten, or tantalum) of any suitable shape or size, which can be observed using ultrasound, X-ray, computed tomography (CT), or any other suitable imaging technique. However, it should be understood that any other suitable type of marking can be utilized, including radiopaque markings in some cases.

[0094] Figure 3 The illustrated artificial valve portion 106 may include markings 210A and 210B on the ends of positioning members 204A and 204B. A member 212 disposed at the proximal end 105 of the artificial valve portion 106 may also have markings 212A and 212B to which it is connected. Additionally or alternatively, one or both of the leaflets 206A and 206B may have markings to which they are connected. Figure 3 The diagram illustrates, by way of example, a marker 213 attached to the edge of leaflet 206A. However, it should be understood that one or more markers may be attached to one or both of leaflets 206A and 206B at any location on the surface of one or both. Furthermore, in some embodiments, a portion or entire area of ​​the ridge 205 or other portions of the artificial valve portion 106 may be radiopaque or otherwise detectable using various imaging techniques, thereby additionally facilitating the determination of the artificial valve's location.

[0095] The arrangement of the markers may depend on the configuration of the artificial valve portion and any other factors. Regardless of how the markers, of suitable size and shape, are arranged on one or more sites of the implant described herein, the markers can be used to track the position of the implant and / or portions of the implant during use. Furthermore, in some embodiments, the markers may be omitted, and the position of the implant may be determined in any suitable manner, as the embodiments described herein are not limited thereto.

[0096] The implant, according to some embodiments, may include an artificial valve portion having any suitable configuration. For example, in some embodiments, such as Figure 4A , Figure 4B and Figure 4C As shown, the implant 402 includes an artificial valve portion 406, which includes a valve body 427 having a deployable / retractable frame. The frame 427 has proximal and distal portions 432, 434, wherein the proximal portion 432 is coupled to the distal end 412 of an inner shaft 408 having proximal and distal ends 412, 414. The inner shaft 408 has a distal portion 416, a middle portion 418, and a proximal portion 420 coupled to an anchorage portion 410. In some embodiments, the inner shaft 408 may be configured as one or more tethers (e.g., formed by one or more sutures) extending between the distal end of the artificial valve 406 and the anchorage portion 410. The tethers can be slidably connected to the anchorage portion 410, for example, via a locking member coupled to the anchorage portion 410, to allow adjustment of the distance between the artificial valve portion 406 and the anchorage portion 410 by adjusting the length of the tethers.

[0097] Similar to Figure 1A and Figure 1B The anchoring portion 110 shown may include a distal portion, a middle portion, and a proximal portion 42, 424, 426. The distal and proximal portions 422 and 426 are configured to expand to form deployable wings 428 and 430, as shown. Figure 5A and 5B As shown in the diagram, the deployable wings 428 and 430 can be configured to form a shape similar to... Figure 1B The deployable wings 128 and 130 are shown.

[0098] like Figures 4A to 4C As shown, the artificial valve portion 406 has a positioning member 436 configured to be circumferentially connected to a ring on the distal portion 434 of the valve body 427. The positioning member 436 is connected to the valve body 427 via legs 438a-438f, which can be positioned as follows: Figures 4A-4C The bend shown makes the artificial valve portion 406 conform to the geometry and function of a natural heart valve. It should be understood that six legs 438a-438f are shown only as an example, as any suitable type and any suitable number of structural features can be used to connect the positioning element 436 to the valve body 427.

[0099] It should also be understood that the positioning element 436 may be integrally formed with the valve body 427. The positioning element 436 may have a configuration different from that of a ring and may additionally or alternatively include any number of structural features. For example, the positioning element 436 may have a plurality of structural features arranged circumferentially around the distal portion 434 of the valve body 427. In some embodiments (e.g., where the positioning element 436 is integrally formed with the valve body 427), the positioning element 436 may be formed from the same elements or segments as those used to form the valve body 427. The positioning element 436 may be formed as a ring or as a plurality of structures having any suitable shape terminating at the distal end of the member 436.

[0100] In some embodiments, the artificial valve portion 406 may include an insert (not shown) disposed inside a portion or the entire area of ​​the valve body 427 and / or the positioning element 436. The insert is arranged such that it cushions the interior of the valve portion 406 and provides additional structural integrity to the artificial valve portion 406 in use. The insert may be formed of any suitable material. For example, the insert may be formed of natural materials such as bovine pericardium and / or porcine pericardial tissue. Additionally or alternatively, the insert may be formed of synthetic materials such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or any other suitable material.

[0101] The valve body 427 can be fitted to the inner shaft 408 via struts 440A, 440B, and 440C, such as Figure 4A and 4B As shown in the diagram. However, it should be understood that the valve body 427 can be fitted to the inner shaft 408 using any number of other structural elements. Figure 4A and 4B As shown, the distal end 412 of the inner shaft 408 is configured as a connection for the struts 440A, 440B, and 440C, at which the struts 440A, 440B, and 440C are attached to the inner shaft 408. 440A, 440B, and 440C can be fixedly or flexibly attached to the connection. For example, in some embodiments, the connection is configured as a rotary joint or other similar mechanism to allow the valve body 427 to rotate relative to the connection or move in any direction without interfering with or altering the orientation of the inner shaft 408 and the anchorage 410 to which the inner shaft 408 is attached.

[0102] The artificial valve portion 406 may be self-expanding or expandable using an additional device, such that, in its pre-expanded configuration, the diameter of the artificial valve portion 406 allows it to be inserted into the guide assembly. Figures 4A-4CThe artificial valve portion 406 is located within an outer shaft (not shown) and delivered to a region of the heart (e.g., the atrium) via the outer shaft. Upon deployment, the artificial valve portion 406 is radially deployed away from the distal end 412 of the inner shaft 408 and reversibly self-locked to remain in an expanded configuration to adapt to the shape of the heart valve. The artificial valve portion 406 can be configured to deploy in such a way that, when the valve 406 is suspended within the opening of the mitral valve, upward and downward movement of the artificial valve portion 406 is prevented. In the deployed state, the artificial valve portion 406 can expand and contract to change its diameter and overall configuration to adapt to the dynamic geometry of the heart valve (e.g., the mitral valve) as the heart pumps blood.

[0103] The positioning element 436 is configured to deploy in any suitable manner. For example, the annular positioning element 436 portions between the attachment sites of the legs 438a-438f can slide overlapping each other, allowing the positioning element 436 to expand and contract. Regardless of the specific geometry and cable configuration of the artificial valve portion, the artificial valve portion 406 can be configured to expand and contract in corresponding deployed and non-deployed configurations.

[0104] Although not shown in Figures 4-5, in some embodiments, the prosthetic valve portion 406 or any other portion of the implant 402 may include one or more markers that help determine, for example, the location of the prosthetic valve portion 406, and thus guide the cardiac surgeon / cardiologist in the delivery, deployment, adjustment, and / or removal of the implant 402. Similar to the markers described with respect to the prosthetic valve portion 106, the markers arranged on the implant 402 may be radiopaque or otherwise detectable using any suitable imaging technique. The markers may have any suitable size and shape and may be positioned on the implant 402 in any suitable manner.

[0105] It should be understood that the specific cable configuration of the valve body 427, including two rows of hexagonal elements, is merely shown as an example. Figures 4A-4C In the embodiments described, the frame can be formed from any number of suitable circular, oval, elliptical, or other types of elements or segments that can form any regular or irregular pattern.

[0106] The artificial valve portion according to the described technology can be flexible and capable of maintaining its structural integrity, which is ergonomic, conforms to the structure of natural heart valves, and mimics the function of natural valves. The artificial valve portion can have any suitable configuration based on the anatomy of a heart valve such as the mitral, tricuspid, or aortic valve. The artificial valve portion can be formed from stainless steel, Nitinol®, or other biocompatible materials(s). For example, Cu-Al-Ni alloys or other shape memory alloys are used. The artificial valve portion can also be formed from polymers(s). In some embodiments, one or more elements of the artificial valve portion are flexible, allowing the artificial valve portion to adapt to the dynamic geometry of the heart valve.

[0107] In some embodiments, the prosthetic valve portion may be configured to allow it to be suspended within the heart valve using one or more positioning elements, with or without tissue puncture. In combination Figures 4A to 4C In the illustrated example, the positioning element 436 may be configured to engage the heart valve annulus such that the positioning element 436 is positioned above the valve orifice and the valve body 427 is suspended within the orifice. The positioning element 436 may be configured to withstand displacement forces applied thereon (e.g., during cardiac contraction) and thus remain in a precise position and reduce the risk of movement of the valve body 427 suspended within the orifice of a natural heart valve (e.g., the mitral valve).

[0108] like Figure 4C As shown, when the implant 402 is inserted into the heart, the implant anchor 410 located at the apex of the heart can removably engage with the actuator 442, which is used to actuate the deployable wings 428, 430. Figure 5A and 5B The expansion shown in the figure. Figure 5A Implant 402 is shown, in which wings 428, 430 are deployed to engage the tissue between them. Figure 5B Additionally, a mating structure 444 is shown at the proximal end of the anchoring portion 410 for engaging the distal end 446 of the actuator 442 or other instrument. Figure 4C ).

[0109] As mentioned above, in some embodiments, the inner shaft of the implant may include a tether portion having one or more tethers extending between the artificial valve portion and the anchoring portion. The tether portion may be connected to the anchoring portion using a tether lock or tether clip of any locking element. Before connecting the tethers to the anchoring portion using the tether lock, the proximal ends of one or more tethers are retracted proximally to the proximal end of the anchoring portion. In some embodiments, the tether portion is formed of an absorbable or non-absorbable material, such as suture. The tether portion is formed of a suitable metallic material and may be cable suture (e.g., metal suture). Those skilled in the art will understand that the tether portion may include any number of tethers formed of any suitable material.

[0110] Figure 5C-5H Examples of implants and their use are shown according to some embodiments, in which the inner shaft is formed by one or more tethers.

[0111] Figure 5C-5F A system 500 for repairing heart valves according to some embodiments is shown. Figure 5C As shown, system 500 may include an implant 502 and an external shaft 504 defining a lumen extending therethrough, the lumen being configured to slidably receive the implant 502 therein. Similar to external shaft 104 ( Figure 1A The outer shaft 504 may be a component configured to deliver the implant 502 into the heart as a guide assembly.

[0112] like Figure 5C As shown, the implant 502 includes an artificial valve portion 506, a tether portion 508, and an anchor portion 510. The artificial valve portion 506 can be connected at its proximal end 505 to the distal end 512 of the tether portion 508, and the anchor portion 510 can be connected to the proximal end 514 of the tether portion 508.

[0113] like Figure 5E As shown, an artificial valve portion 506 is depicted in an expanded or contracted configuration. The valve portion 506 may have a valve body 527 including an expandable / contractable frame. The frame 527 is similar to... Figures 4A-4C The valve body or expandable / contractable frame 427 is shown. Furthermore, similar to the valve body 427, the artificial valve portion 506 may have a positioning element 536 configured circumferentially connected to the distal portion of the valve body 527 and / or a ring and / or multiple elements or segments integrally formed with the valve body 527 to conform to the geometry of a natural heart valve. It should be understood that the valve portion 506 may have any number of elements with any suitable configuration.

[0114] Figure 5E Anchoring portion 510 is shown to include a distal portion, a middle portion, and a proximal portion 522, 524, 526. The distal and proximal portions 522 and 526 of anchoring portion 510 are configured to expand to form Figure 5C , 5D And the deployable wings 528, 530 shown in 5F. The deployed wings 528, 539 are capable of maintaining an expanded configuration until the anchor 510 is operated, causing the wings 528, 530 to retract into a non-expanded configuration. It should be understood that the implant 502 may include any other configuration not shown herein, configured such that the anchor 510 can reversibly form the wings 528, 530.

[0115] like Figure 5C-5FAs shown as a non-limiting example, the tether portion 508 may include one or more tethers 509 extending between the artificial valve portion 506 and the anchor portion 510. The tethers 509 are capable of extending between the artificial valve portion 506 and the anchor portion 510 such that they can also extend through the anchor portion 501 and protrude beyond the proximal end 532b of the anchor portion 510. Figure 5D and 5F The proximal end 511 of the tether 509 extending from the proximal end 532b of the anchoring portion 510 is shown.

[0116] like Figure 5E As shown, the tether 509 can be attached to the artificial valve portion 506 at various attachment points 516A, 516B, 516C, which can be achieved in any suitable manner. For example, the tether 509 passes through one or more openings or holes formed in the structural elements of the valve portion 506. In one exemplary embodiment, the tether 509 may be integrally formed with the valve portion 506. Additionally or alternatively, the valve portion 506 clamps the tether 509, and / or any retaining structure may be used to attach the tether 509 to the artificial valve portion 506. It should be understood that... Figure 5C-5F The diagram shows only three tethers as an example, but the tether section 508 may include any number of tethers (e.g., one, two, four or more) that are attached to the artificial valve section 506 in any suitable manner.

[0117] The tether portion 508 may be formed from one or more absorbable or non-absorbable sutures (or any combination thereof) extending between the artificial valve portion 506 and the anchor portion 510. Therefore, the tether 509 may be flexible and / or elastic, allowing it to be tensioned when adjusting the distance between the artificial valve portion 506 and the anchor portion 510. Furthermore, the flexibility and / or elasticity of the tether 509 can provide elasticity to the position of the valve portion 506 during cardiac systole and diastole, thereby enabling the valve portion 506 to mimic the function of a natural heart valve.

[0118] The tether 509 can be held within the implant 502 in a variety of ways. In the illustrated embodiment, as... Figure 5C-5F As shown, the anchoring portion 510 is connectable to or includes a tether lock 513 at its proximal end 532b, the tether lock being configured to reversibly lock the tether 509 therein. The tether lock 513 may be a clip or any other device configured to reversibly hold the tether 509 in a fixed position. Although not shown, in some embodiments, the implant 502 may include a tether lock recessed into the body of the anchoring portion 510 so that the lock does not protrude into the pericardial cavity.

[0119] In use, after the implant 502 is delivered to the heart via the outer shaft 504 of the guide assembly through the apex, the artificial valve portion 506 can be configured from non-expanded or contracted (e.g., Figure 5C and5D (as shown in the image) movement to an unfolded or expanded configuration (e.g., Figure 5E and 5F (As shown in the diagram). The artificial valve portion 506 can be positioned within the opening of a valve (e.g., a mitral valve) such that the valve body 527 is suspended at the tip of the mitral valve. The proximal end 532b of the anchor portion 510 can engage with the actuator 534 ( Figure 5E The actuator 534 can be used to manipulate the anchor 510 to cause the deployable distal and proximal wings 528 and 530 to... Figure 5F The expansion shown in the diagram further anchors the implant 502 within the apex of the heart.

[0120] In some embodiments, the length of the tether portion 508 can be adjusted before or after the deployment of the wings 528, 530. This adjustment can be made at any point in time after the implant 502 is placed. For example, actuator 534 ( Figure 5E Or any other suitable device can be fitted to the tether lock 513 at the proximal end 532b and used to adjust the length of the tether 509, thereby adjusting the distance between the artificial valve 506 and the anchor portion 510 to ensure the accurate position of the valve portion 506 within the natural valve. This allows for adjustment such as Figure 5E and 5F The position of the artificial valve portion 506 in the expanded configuration is shown. Additionally, in some embodiments, the artificial valve portion 506 and / or other portions of the implant 502 may be rotated to adjust the position of the artificial valve portion 506.

[0121] The length of the tether portion 508 can be adjusted in any suitable manner. For example, it can be an actuator of any suitable adjusting tool configured to engage with the proximal end of the anchor portion 510 for releasing the locking mechanism of the tether lock 513. In this way, one or more tethers 509 can be released to increase the length of the tether portion 508, or retracted proximally (e.g., by pulling) to decrease the length of the tether portion 508. All tethers 509 can be adjusted together or manipulated and adjusted independently of the other tethers of the tether portion 508, thereby (e.g.) adjusting the position of the artificial valve portion 506 within the natural heart valve.

[0122] It is understood that the locking mechanism of the tether lock 513 can be manipulated in any suitable manner to adjust the length of the tether portion 508. After the desired adjustment is completed, the tether lock 513 can be manipulated to lock the tether 509 in a fixed position.

[0123] After the adjustment is completed, such as Figure 5FThe removable actuator 534 is shown. It should be understood that any portion of the tether 509 may extend beyond the proximal portion 510 of the anchorage 510, and in some cases, some or all of the tether 509 may not protrude beyond the proximal end 532b of the anchorage 510.

[0124] Figure 5G and Figure 5H Other exemplary embodiments of the implant with an adjustable tether section are shown. Figure 5G In the exemplary embodiment of the implant 502' shown, the tether portion 508' has first and second portions 517, 519 formed by flexible sutures. The first distal portion 517 is attached to the artificial valve portion 506', while the second proximal portion 519 is slidably attached to the anchor portion 510. Figure 5G As shown, the first and second portions 517 and 519 can pass through the connecting portion 520 and loop together. The proximal end 511' of the tether of the second portion 519 extends through the anchor portion 510' and protrudes beyond its proximal end. Similar to... Figure 5C-5F In the embodiment shown, the distance between the artificial valve portion 506' and the anchor portion 510' can be adjusted by manipulating the tether lock 513'.

[0125] In use, since the first and second portions 517, 519 can slide relative to each other at the connection 520, the annular arrangement of portions 517, 519 allows the artificial valve 506' to rotate in any direction without interfering with the orientation of the anchor portion 510' (e.g., after its proximal and distal wings have deployed).

[0126] exist Figure 5G In an exemplary embodiment, the first and second portions 517 and 519 each form a loop. Those skilled in the art will understand that any number of loops can be included in the first and second portions of the cord portion. For example, Figure 5H Implant 502'' is shown, which has a similar Figure 5G The tethering portion 508' of the implant 502'. The first part 517'' of the tethering portion 508'' includes two loops 515A and 515B. Figure 5H As shown, the first part 517'' connects to the second part 519'' of the tethering part 508'' at the connecting part 520''. Similar to... Figure 5G In one embodiment, the proximal end 511'' of the tether of the second part 519'' can extend through the anchoring part 510'' and protrude beyond its proximal end. The length of the tethering part 508'' can be adjusted by manipulating the tether lock 513'' to adjust the distance between the artificial valve part 506'' and the anchoring part 510''.

[0127] It should be understood that, in combination Figure 5C-5HThe implant in the described embodiments may include any other components that can be additionally or alternatively used to adjust the position of the artificial valve within the natural heart valve. For example, in some embodiments, the tether portion of the implant is used to manipulate the tether to rotate the artificial valve or otherwise adjust its position. Furthermore, the tether locks 513, 513', 513'' are shown only as examples, as the distance between the artificial portion and the anchor portion can be adjusted by any other mechanism.

[0128] Regardless of the specific configuration of the inner shaft and the tether extending between the artificial valve portion and the anchoring portion, an actuator tool (e.g., tool 134, 442, 534, or other suitable instrument) can be used to manipulate the implant (e.g., implant 402, 502, 502', or 502'') to adjust the distance between the artificial valve portion and the anchoring portion. Additionally or alternatively, the actuator or other suitable instrument can be used to rotate the entire implant or a portion thereof (e.g., the artificial valve portion). The actuator or other device capable of being coupled to the anchoring portion can be inserted percutaneously. The adjustment process can be guided using fluorescence or other suitable techniques.

[0129] Figures 6A to 6J A method for repairing a patient's heart valve is illustrated using the exemplary system 100 described above in conjunction with Figures 1-3. A cross-sectional view of the patient's heart 602 is shown in... Figure 6A-6J As shown in the image.

[0130] Figure 6A A cross-sectional view of a heart is shown, featuring a mitral valve 604 located between the left ventricle 606 and the left atrium 608. The mitral valve 604, comprising leaflets 610 and 612, can become diseased, preventing it from closing completely when the heart 602 pumps blood. In this case, during left ventricular contraction 606, blood flows along… Figure 6A The direction indicated by the middle arrow 603 is the leakage (recirculation) from the left ventricle 606 through the mitral valve 604 back into the left atrium 608. The mitral valve 604 may also have other defects that can be mitigated using the techniques described herein.

[0131] A system 100 for repairing mitral valve 604 regurgitation may include a guide assembly 614 having an outer shaft 104 (also... Figure 1A (As shown in the image), the outer shaft has a proximal end and a distal end 616, 618. For example... Figure 6A As shown, the outer shaft 104 (part of which is in) Figure 6A (As shown in the diagram) It can be inserted into the left ventricle 606 through the apex 601 of the heart 602 at the implantation site 607. For example, a catheter system or any other system can be used to manipulate the guide assembly 614 to insert and move the outer shaft 104 toward the left atrium 608.

[0132] The external shaft 104, introduced through the apex 601, can be advanced further distally toward the left atrium 608. In this way, the maneuverable shaft 104 can pass through the opening of the mitral valve 604 until the distal end 618 of the external shaft 104 is located within the left ventricle 608, as... Figure 6B As shown in the image. Figure 6B The distal end 618 is shown protruding above the opening of the mitral valve 604. It should be understood that the outer shaft 104 can protrude within the left atrium 608 to any suitable distance, which allows the artificial valve to deploy within the atrium.

[0133] In some embodiments, the implant can be delivered into the patient's heart via an external shaft 104. The external shaft 104 may have a lumen defined therein, which receives various components passing through it. Implants according to some embodiments, such as those shown in Figures 1-3, can be configured to be removably inserted into the external shaft 104 via its proximal end 616 and through the lumen of the external shaft 104 toward the left atrium 608. The implant 102 passes through the external shaft 104 such that its distal end 103 enters and exits the external shaft 104 first. Figure 1A and 1B As shown, the implant 102 can be configured to retract or fold, and it can be inserted through the outer shaft 104 in this non-expanding configuration.

[0134] Therefore, since the movable implant 102 passes through the external shaft 104, the artificial valve 106 located at the distal end of the implant 102 can be moved from the distal end 618 of the external shaft 104 into the left atrial space in a non-deployed configuration, as... Figure 6C As shown in the diagram. The artificial valve 106 can be connected to the distal end 112 of the inner rod 108 inserted through the outer rod 104, a portion of the inner rod 108 being in... Figure 6C The figure shows a protrusion from the outer shaft 104. In some embodiments, the artificial valve 106 can be integrally formed with the inner shaft 108.

[0135] like Figure 6D As shown, the artificial valve 106 can be deployed to move from a non-expanded configuration to an expanded configuration, and the valve body 202 and positioning elements 204A, 204B ( Figure 2A , 2B The artificial valve 106 (as shown in Figure 3) is opened or dilated. Any suitable mechanism can be used to open the artificial valve 106. For example, the artificial valve 106 can operate like a spring-loaded umbrella when actuated and opened. However, other mechanisms may be used additionally or alternatively.

[0136] Figure 6DThe diagram shows that before the prosthetic valve 106 deploys, the external strut 104 can be retracted from the left atrium 608, such that its distal end 618 is positioned within the opening 605 between the leaflets 610 and 612 of the mitral valve 604. It should be understood that the described technique is not limited to the specific location of the distal end 618 of the external strut 104, as the external strut 104 can be positioned differently depending on the specific anatomy of the patient's heart, the configuration of the prosthetic valve, and other factors.

[0137] Figure 6D The deployed artificial valve 106 shown can be initially positioned within the left atrium 608 such that the positioning elements 204A, 204B are arranged within the left atrium 608 at a distance from the mitral valve annulus 620. Next, the implant 102 can be manipulated such that the position of the artificial valve 106 relative to the mitral valve 604 is adjusted to ensure accurate positioning of the artificial valve 106. Therefore, as... Figure 6E As shown, the external shaft 104 carrying the implant 102 can retract from the left atrium 608 to the left ventricle 606. In this way, the artificial valve 106 can move proximally toward the mitral valve annulus 620, such that the positioning elements 204A and 204B are arranged on the opposite side of the opening 605 of the mitral valve 604, and the valve body 202 is suspended within the opening 605. Figure 6E The artificial valve 106 is shown with its leaflets 206A and 206B positioned within the opening 605 between the natural leaflets 610 and 612 of the mitral valve 604.

[0138] Positioning elements 204A and 204B can engage tissue of the mitral valve annulus 620 without puncturing it. For example, positioning elements 204A and 204B may be at least partially flexible, having a shape that allows them to engage the mitral valve tissue frictionally. Positioning elements 204A and 204B can further engage the mitral valve tissue such that the valve body 202 is situated within the opening of the mitral valve 604. Positioning elements 204A and 204B are configured to engage tissue such that they resist outward forces from the myocardium and do not cause excessive interference with the mitral valve tissue. As another advantageous feature of the described technique, the artificial valve can be configured and deployed in such a way that the risk of left ventricular outflow tract (LVOT) obstruction is reduced or eliminated, and left ventricular (LV) function is protected. Therefore, the risk of coagulation is reduced or eliminated.

[0139] In some embodiments, the location of the artificial valve 106 can be determined using appropriate markings, such as, for example... Figure 3 One or more ray markers 210A, 210B, 212A, 212B, and 213 are shown. The markers can be tracked using appropriate imaging techniques and thus used to guide the surgeon during delivery, deployment, adjustment, and / or removal of the implant 102.

[0140] like Figure 6F As shown, when the artificial valve 106 is suspended within the opening 605 of the mitral valve 604, the outer strut 104 can retract proximally toward the apex 601 of the heart 602 so that a portion of the inner strut 108 is exposed within the left ventricle 606. As discussed above, the inner strut 108 may include distal, intermediate, and distal portions 116, 118, 120. As the outer strut 104 further retracts toward the apex 610, it eventually retracts completely from the left ventricle 606, as... Figure 6G As shown, the anchoring portion 110 of the implant 102 may also be exposed. Figure 6G As shown, the implant 102 is delivered to the heart 602 in such a manner that the anchoring portion 110 can be positioned within the apex 601 of the heart. Similarly, as... Figure 1B As shown, the anchoring portion 110 may include distal, intermediate, and proximal portions 122, 124, and 126.

[0141] like Figure 6G As shown, the proximal end 622 of the anchor 110 is connected (e.g., slidably or otherwise) to the distal end 618 of the outer shaft 104. The proximal end 622 engages with an actuator, such as actuator 442 (not shown), which can be used to manipulate the anchor 110 to cause it to deploy its deployable distal and proximal wings 128, 130. Figure 1B and 2B This allows the implant 102 to be anchored within the apex of the heart. Thus, as... Figure 6H As shown, the distal portion 122 of the anchor 110 can first unfold to form the distal wing 128. The proximal portion 126 of the anchor 110 then unfolds to form the proximal wing 130, as... Figure 6I As shown in the illustration. It should be understood that, by way of example only, the distal wing 128 deploys before the proximal wing 130 deploys. In some embodiments, the proximal wing 130 may deploy before the distal wing 128 deploys. Also, in some embodiments, the distal and proximal wings 128, 130 may deploy simultaneously or substantially simultaneously.

[0142] In some embodiments, the length of the inner shaft 108 is adjustable before or after the deployment of the wings 128, 130. The distal and intermediate portions 116, 118 of the inner shaft 108 are configured to slide inwardly relative to each other. For example, the intermediate portion 118 can slide on the distal portion 116 to receive at least a portion of the distal portion 116 and reversibly lock in this configuration. This allows the combined length of the intermediate and distal portions 116, 118 to be varied, thereby allowing for changes in the length of the inner shaft 108. Additionally, in some embodiments, the proximal portion 120 of the inner shaft 108 may be configured to receive a portion of the intermediate portion 118. After the length of the inner shaft 108 of the implant 102 is adjusted as needed, the implant 102 can be fixed intraapically.

[0143] The middle portion 124 of the anchor 110 can be positioned within the tissue of the apex 601, and the wings 128, 130 can engage the tissue between them. The middle portion 124 may have a fixed length, or in some cases, the length of the middle portion 124 may be adjustable so that the middle portion 124 can span tissue walls of different thicknesses. Figure 61 shows the distal and proximal wings 128, 130 positioned within the tissue of the apex 601 of the heart 602. However, in some embodiments, the wings 128, 130 may be positioned on the opposite side of the apical wall, as the embodiments described herein are not limited to this particular manner. The deployable wings 128, 130 are thus positioned to anchor the implant 102 to the apex. In some embodiments, the distal wing 128 deploys against the apical wall and the proximal wing 130 deploys within the tissue. In other embodiments, the proximal wing 130 may deploy against the apical wall and the distal wing 128 deploys within the tissue. In both of the above scenarios, the distal wing 128 may be deployed before, after, or simultaneously with the deployment of the proximal wing 130, and the described technology is not limited thereto.

[0144] Regardless of the manner and specific location of the deployment of the distal and proximal wings 128 and 130, after the wings 128 and 130 are deployed, the outer shaft 104, including a suitable anchoring tool for deploying the artificial valve 106 and the anchor 110, can be removed from the implantation site, so that the implant 102 with the artificial valve 106, suspended within the mitral valve, is anchored within the apex of the heart, as... Figure 6J As shown in the image.

[0145] Therefore, implant 102 can be removably placed within the heart in a simple and cost-effective manner. Transapical delivery of the implant simplifies surgery and reduces patient trauma, avoiding open-heart surgery and reliance on cardiac bypass systems. The implant can be anchored within the apex of the heart without the use of sutures, purse-string closures, or other additional connecting structures. The insertion site of the implant can be easily closed, reducing blood loss.

[0146] In some embodiments, after the implant is anchored at the apex of the heart and the prosthetic valve is suspended on the annulus of a heart valve (e.g., the mitral valve), the distance between the prosthetic valve and the anchor can be adjusted. The anchor can be configured such that its proximal end receives a suitable adjustment tool, which can be used to adjust the length of the inner shaft, thereby adjusting the position of the prosthetic valve within the mitral valve. In some embodiments, additionally or alternatively, only the prosthetic valve, or the entire implant, can be rotated when the implant is deployed.

[0147] In embodiments where one or more tethers are used to connect the artificial valve to the anchorage (e.g., as...), Figure 5C-5HAs shown in the diagram, a suitable adjustment tool can be used to engage the proximal end of the anchorage and to unlock the tether clamp, thereby adjusting the position of the artificial valve within the heart valve (e.g., the mitral valve). Upon completion of the adjustment, the tether clamp is manipulated to lock the tether to the anchorage.

[0148] The implant is adjustable to correct for various conditions, and this adjustment can be made at any time after implant placement. For example, the implant needs to be readjusted when any part of the implant moves from its position, causing blood to flow through the space between the implanted valve structure and the heart tissue (e.g., paravalvular leak occurs). The described technique allows for the treatment of paravalvular leaks or other conditions after the implant has been delivered to the heart. The implant can be adjusted (e.g., by adjusting the distance between the prosthetic valve and the anchorage and / or rotating the implant or portions thereof), or the prosthetic valve can be replaced after complete removal of the implant. Therefore, the described technique provides a simple and repeatable prosthetic valve implantation procedure that reduces tissue trauma and the risks associated with open-heart surgery.

[0149] Figure 7A and 7B An adjustment tool 702 is shown, which engages with the anchor 110 at the proximal end 132 of the anchor. The adjustment tool 702 can be a cable screwdriver or any other suitable tool. The cable screwdriver may have a hollow shaft. The distal end of the adjustment tool 702 can be inserted into the anchor 110. The adjustment tool 702 can be used to adjust the length of the inner shaft 108, thereby raising or lowering the artificial valve 106 relative to the mitral valve, thus adjusting the position of the implant during the movement of the mitral valve 604 during heartbeats.

[0150] In embodiments including a tether portion configured to adjust the artificial valve and the anchoring portion (e.g.) Figure 5C-5H In the embodiment shown, the adjustment tool 702 can be placed on one or more tethers extending beyond the proximal end of the anchorage. The tool 702 can be used to manipulate a locking mechanism (e.g., tether lock 513) configured to reversibly retain the tethers. This allows adjustment of the distance between the artificial valve portion and the anchorage.

[0151] As described above, implants according to some embodiments can be removed from the implantation site in a simple, time-saving, and non-invasive manner. After removal, another implant can be inserted into the site of the defective natural valve. This is necessary, for example, when implants need to be positioned differently, different types of implants are desired, or for any other reason. Therefore, implant placement procedures according to some embodiments are repeatable without causing trauma to the cardiac tissue.

[0152] Figures 8A-8F The method for removing the binding is shown. Figure 6A-6JThe reverse process of the delivery and deployment of the implant 102 is shown. Figure 8A A reversing tool 802 is shown, which can be any suitable instrument capable of engaging with the proximal end 132 of the deployed implant 102. Tool 802 can be any suitable instrument to move the deployed wings 128, 130 from an expanded configuration to a non-expanded configuration and is capable of locking in place upon insertion through the proximal end 132. Figure 8B In the diagram, the anchor 110 is shown together with the folded wings 128 and 130, such that the distal and proximal ends 122 and 126 of the anchor 110 are shown in their pre-deployed configuration, without the wings formed. Next, similarly... Figure 8B As shown, the external shaft 104 can be inserted into the reversing tool 802 and advanced distally toward the left atrium 608 on the implant 102 having folded wings 128, 130. The external shaft 104 advances into the left ventricle 606 until the distal end 618 of the external shaft 104 is positioned near the proximal end 105 of the artificial valve 106, as shown. Figure 8C As shown in the example. In some embodiments, as shown in this example, the outer shaft 104 can be advanced distally until only the distal end 112 of the inner shaft 108 is exposed.

[0153] Figure 8D The outer shaft 106 can be further inserted such that its distal end 618 is positioned within the left atrium 608. The artificial valve 106 can then be folded in a suitable manner. For example, in one embodiment, the artificial valve portion 106 can be pulled proximally or otherwise manipulated, causing the positioning elements 204A, 204B and leaflets 206A, 206B to fold like an inverted umbrella. In this way, the artificial valve 106 can be moved from an expanded configuration to a non-expanded configuration, in which the valve 106 is compressed and can be fitted onto the outer shaft 104 for removal. It should be understood that the mechanism for folding the artificial valve 106 is shown by way of example only, and the artificial valve 106 can have any other structure that allows the valve to unfold / fold in any suitable manner.

[0154] After the artificial valve 106 is folded, the implant 102 can be removed from the implantation site via the external shaft 104 (e.g., using a reversing tool 802 or other instrument). Therefore, Figure 8E A cross-sectional view of the heart 602 is shown, in which the artificial valve 106 has been pulled into the outer shaft 104 and only the outer shaft 104 is visible.

[0155] After the implant 102 is removed from the left atrium 608 via the external shaft 104, the external shaft 104 can also move from the left atrium 608 through the mitral valve 604 into the left ventricle 606. Although still positioned within the left ventricle 606, the external shaft 104 can be positioned such that its distal end 618 extends above the apex 601 of the heart 602, as... Figure 8FAs shown in the diagram. In some embodiments, the outer shaft 104 can be completely removed from the implantation site. Furthermore, in some embodiments, the implantation site 607 of the implant 102 can then be closed, as illustrated. Figures 9A to 9E As shown in the image.

[0156] Figure 9A An additional implant, referred to herein as a closure implant or closure device 904, is shown, which can be introduced via an outer shaft 104, advanced distally through the lumen of the shaft 104, and released from the distal end 618 of the shaft 104. The closure device 904 can be configured in a manner similar to the anchor 110 or in any other suitable manner.

[0157] exist Figures 9A-9E In the illustrated embodiment, the occlusive implant 904 may include proximal, intermediate, and distal portions 906, 908, and 910. The proximal and distal portions 906 and 910 may be configured to expand to form proximal and distal deployable wings 912 and 914, both of which are located in... Figure 9D and 9E As shown in the figure. The proximal and distal deployable wings 912, 914 can deploy to engage the tissue between them and thereby close the hole created by the implant 102 at the apical tissue of the implantation site.

[0158] When the distal end 618 of the outer shaft 104 is positioned within the left ventricle 606, a suitable driving tool received via the outer shaft 104 (which may be the same as or different from the reversing tool 802) can be used to deploy the distal wing 914 of the occlusive implant 904, such as Figure 9B As shown in the diagram. The outer shaft 104 can then be pulled proximally toward the apex 601 of the heart 602 so that the outer shaft 104 is completely or partially removed from the apex 601. As... Figure 9C As shown in the diagram. Movement of the outer shaft 104 causes the closure implant 904 to approach the apex 601, and the closure implant 904 with its deployed distal wing 914 is positioned within the tissue of the apex 601, as illustrated in the example by 9D. However, it should be understood that in some embodiments, the distal wing 914 may be located within the left ventricle 606 lateral to the wall of the apex 601, and the intermediate portion 908 may cross the apical wall. Furthermore, in some cases, the distal wing 914 is deployed after the closure implant 904 has been at least partially inserted into the apex 601 and is in a ready-to-deploy position.

[0159] Figure 9D This illustrates that after the distal wing 914 deploys, the proximal wing 912 can deploy to engage the tissue between wings 912 and 914. This seals the perforation created by the implant 102 within the apical wall. After the implant 904 has deployed, the outer shaft 104 can be detached from and removed from the implant 904, as shown. Figure 9E As shown in the image.

[0160] Implants according to the described technology may include artificial valves having any suitable configuration that allows the artificial valve to have a non-expanding or folded configuration for delivery to or removal from a heart valve, and to have an expandable configuration for use when the artificial valve is expanded within a defective heart valve.

[0161] Based on their structure, artificial valves can be described alternatively or additionally as being configured to move between folding and expanding configurations. The structure of an artificial valve can be selected based on the anatomical context of the natural valve to be repaired or replaced, the patient's characteristics, and / or any other factors.

[0162] Figure 10 This is a cross-sectional view of heart 602, which shows... Figures 4A-4C Implants 402 (5A and 5B) are delivered apically into the heart 602 to repair or replace the mitral valve 604. Implant 402, as... Figure 10 The implant 402 shown is removable and replaceable within the heart 602. The implant 402 may have an inner shaft 108 and an anchoring portion 110 similar to those of implant 102. Figure 6J The implant 402 (shown in a fully expanded configuration) includes an inner shaft 408 and an anchorage 410. However, the implant 402 may also have an artificial valve portion 406 configured as a deployable / foldable cable frame (e.g., a wire mesh or other flexible structure). In some embodiments, the artificial valve portion 406 may include an insert and one or more portions linergaging the valve portion 106, and is configured to provide closure of a natural valve opening or other body opening into which the artificial valve portion 406 is inserted. Furthermore, in some embodiments, the deployable / foldable cable frame may be connected to the anchorage 410 via sutures / tethers, such as... Figure 5C-5H As shown in the image.

[0163] Artificial valve portion 406 can be configured to be located within a guide assembly (e.g., outer shaft 104) for delivering implant 402 to mitral valve 604. Figure 10 (Not shown in the image) It unfolds automatically upon release. For example... Figure 10 As shown, the artificial valve portion 406 is positioned within the opening of the mitral valve 604 such that, in this example, the positioning member 436, shaped as a deployable / foldable ring, is configured to engage the tissue of the mitral valve annulus 620, thereby suspending the valve body 427 over the end of the mitral valve 604. The distal and proximal portions 422, 426 of the anchoring portion 410 are configured to deploy from the deployable wings 428, 430 to anchor the implant 402 to the apex 601, as shown. Figure 10As shown in the diagram. In some cases, the proximal end of the implant 402 may be positioned within the pericardial cavity. The proximal end 1002 may be accessible to adjust the distance between the mitral valve and the anchorage fixed to the apex of the heart by adjusting the length of the inner shaft 408 or one or more tethers, such as suture tethers.

[0164] After deployment, the prosthetic valve portion 406 can expand and contract to assist the mitral valve 604 in proper functioning. Therefore, the prosthetic valve portion 406 is operable, thereby eliminating mitral regurgitation during systole. Furthermore, the prosthetic valve portion 406 can be operated without obstructing blood flow from the left atrium to the left ventricle during diastole. After the implant 402 is deployed, it can be manipulated to adjust the distance between the prosthetic valve portion 406 and the anchor portion 410 and / or rotate the implant 402 or a portion thereof.

[0165] In embodiments where the implant includes a tether portion extending between the artificial valve portion and the anchor portion (e.g., Figure 5C-5H The implants 502, 502', and 502'' in the device allow for adjustment of the distance between the artificial valve portion and the anchoring portion by adjusting the length of one or more tethers. This adjustment can be performed at any point after implantation (e.g., adjusting the implant's position after it has been moved from its proper location), and also during implant placement. In some cases, this adjustment can reduce or eliminate paravalvular leakage, and address any other conditions caused by improper implant positioning. Figure 5B A mating part 444 for engaging a suitable adjustment tool is shown (e.g., Figure 4C The distal end 446 of the actuator 442 is used for adjusting the deployed implant 402. The implant 402 can be accessed percutaneously for adjustment, and the adjustment process can be guided using suitable non-invasive techniques, such as, for example, fluorescence imaging.

[0166] It should be understood that while the illustrated embodiments provide techniques for repairing or replacing the mitral valve, these techniques are also suitable for repairing or replacing other heart valves or for treating other conditions. For example, the tricuspid or aortic valve can be repaired using implants according to some embodiments. Similarly, the left atrial appendage can be repaired using implants according to some embodiments. As another example, the enlarged ventricular volume can be reduced using implants according to some embodiments, and / or faulty valve leaflets can be repaired using implants according to some embodiments.

[0167] Those skilled in the art will understand other features and advantages of the invention based on the above embodiments. Therefore, the invention is not limited to what has been specifically shown and described, except as specified in the appended claims. All disclosures and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. A system for repairing heart valves, comprising: outer shaft; and An implant disposed within the outer shaft, the implant comprising: The inner shaft is formed by multiple ropes. An artificial valve, connected to the distal end of the inner shaft and having an artificial valve body and at least one positioning element, is configured to advance distally from the outer shaft such that the artificial valve moves from a non-expanding configuration, and the at least one positioning element is configured to suspend the artificial valve within an opening in the tissue. An anchoring portion configured to be removably secured to the tissue, the anchoring portion having a distal end connected to the proximal end of the inner shaft, and A tether lock portion is fixedly connected to the proximal end of the anchor portion, the tether lock portion including a locking mechanism configured to reversibly lock the plurality of tethers therein; The multiple tethers are configured to move selectively relative to the anchor and the tether lock, such that when the tether lock is unlocked, the length of the multiple tethers can be adjusted by releasing or retracting the multiple tethers to increase or decrease the distance between the artificial valve and the anchor, and when the tether lock is locked, the multiple tethers are locked at a fixed length. The tether lock is recessed into the anchor and manipulated by an additional tool that is percutaneously inserted into the anchor, thereby enabling percutaneous adjustment of the distance between the artificial valve and the anchor at any point in time after the implant is placed; The plurality of tethers have a first portion and a second portion, the first portion being attached to the artificial valve body and the second portion being slidably attached to the anchoring portion, and the first portion and the second portion passing through each other at the connection portion and looping together, such that the artificial valve body can rotate after it has been deployed without interfering with the orientation of the anchoring portion.

2. The system of claim 1, wherein the artificial valve body comprises an artificial valve leaflet, and the at least one positioning element comprises at least two arms connected to the artificial valve body.

3. The system of claim 1, wherein the artificial valve body comprises an expandable frame, and the at least one positioning element comprises an expandable ring circumferentially disposed at the distal end of the expandable frame.

4. The system of claim 3, wherein the diameter of the expandable frame is adjustable.

5. The system of claim 1, wherein the anchoring portion comprises a proximal deployable wing and a distal deployable wing configured to engage tissue therebetween.

6. The system of claim 1, wherein the at least one tether comprises a stitch.

7. The system of claim 1, wherein the second portion is slidably attached to the anchoring portion.

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