Mitral valve implant for treating valve regurgitation

Abstract

The present invention relates in some aspects to devices for use in transcatheter treatment of mitral regurgitation, the devices comprising steerable guide wires, implantable coaptation assist devices, anchoring systems for attachment of ventricular protrusions of implantable coaptation devices, kits, and methods of using implantable coaptation assist devices, among other methods.

Description

[0001] This application is a divisional application of the application filed on June 17, 2015, entitled "Mitral valve implant for treating valvular regurgitation", with international application number PCT / US2015 / 036260 and Chinese national application number 201580044329.0.

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 014060, filed June 18, 2014, entitled "Mitral Valve Implant for the Treatment of Valvular Regurgitation". The entire disclosure of the prior application is incorporated herein by reference for all purposes. background

[0003] field

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

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

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

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

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

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

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

[0011] Related technical descriptions

[0012] Several therapies have been applied to treat mitral regurgitation, and others are still being proposed but not yet used to treat patients. While several known therapies have been found to benefit at least some patients, further options remain. For example, medications (such as diuretics and vasodilators) can be used in patients with mild mitral regurgitation to help reduce the amount of blood returning to the left atrium. However, drug therapy may lack patient adherence. Many patients may occasionally (or even regularly) fail to adhere to medication, despite the potential severity of chronic and / or worsening mitral regurgitation. Pharmacological treatment of mitral regurgitation can also be inconvenient, often ineffective (especially as the condition worsens), and may be associated with serious side effects such as hypotension.

[0013] Various surgical options have been proposed and / or used to treat mitral regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In annuloplasty annular repair, the posterior mitral annulus can be reduced in size along its circumference, optionally using sutures to mechanically suture the annulus to provide coaptation. Open surgery may also attempt to reshape the leaflets and / or remodel the supporting structures. In any case, open mitral valve surgery is generally a very invasive procedure performed on a cardiopulmonary bypass machine while the patient is under general anesthesia and the thoracotomy is performed. Complications can be common, and given the morbidity (and potential mortality) of open-heart surgery, scheduling becomes challenging—more severely ill patients may desperately need surgery but are less able to tolerate it. Successful open mitral valve surgery can also be highly dependent on surgical skill and experience.

[0014] Given the morbidity and mortality rates of open-heart surgery, innovators have explored less invasive surgical approaches. Methods utilizing robots or endoscopic techniques are generally still quite invasive and can be time-consuming, expensive, and, at least in some cases, highly dependent on the surgeon's skill. It would be ideal to provide even less trauma to these sometimes frail patients, and equally ideal would be to offer a procedure that can be successfully performed by a large number of physicians using varying techniques. To this end, several techniques and methods that are claimed to be less invasive have been proposed. These include devices that attempt to reshape the mitral valve annulus from within the coronary sinus; devices that attempt to reshape the valve annulus by tightening the natural annulus from top to bottom; devices for fusing valve leaflets (mimicking the Alfieri suture); devices for reshaping the left ventricle, etc.

[0015] A variety of mitral valve replacement implants have been developed, perhaps the most well-known, which typically replace (or substitute) the natural valve leaflets and rely on the surgically implanted structure to control the flow of blood between the heart chambers. While these diverse methods and tools meet varying levels of approval, none is yet widely recognized as the ideal treatment for most or all patients suffering from mitral regurgitation.

[0016] Due to the known challenges and drawbacks of minimally invasive mitral regurgitation therapies and implants, alternative treatments are still being proposed. Some of these proposals require the implanted structure to remain within the valve annulus throughout the entire cardiac cycle. One group of these proposals includes structures such as cylindrical balloons that are held in place by a cord or rigid bar extending between the atrium and ventricle through the valve opening. Another group relies on structures such as arcuate rings, often combined with buttresses or structural transverse members extending through the valve to secure the implant. Unfortunately, sealing the entire circumference of the natural leaflet and the balloon or other coaxial structure can prove challenging, and significant contraction around the natural valve annulus during each cardiac stroke can lead to significant fatigue failure of the tissue over long-term implantation if bending of the buttresses or transverse members connecting the retainers is allowed. Furthermore, significant movement of the valve tissue can make accurate implant placement difficult, regardless of whether the implant is rigid or flexible.

[0017] In light of the above, it is ideal to provide improved medical devices, systems, and methods. Particularly desirable are new technologies for treating mitral regurgitation and other valvular heart diseases, and / or for altering the characteristics of one or more of the body's other valves. There remains a need for devices that can directly enhance leaflet occlusion via fusion or other means (rather than indirectly via annular or ventricular remodeling) without disrupting leaflet anatomy, but can be configured simply and reliably without excessive cost or surgical time. It will be particularly advantageous if these new technologies can be implemented using less invasive methods, without requiring cardiac arrest or reliance on a heart-lung machine for configuration, and without relying on the surgeon's expertise, thereby providing improved valvular and / or cardiac function.

[0018] Overview

[0019] In some embodiments, this document discloses an implant for treating valvular regurgitation. The implant may include one or more of the following: a shape memory structure, a biocompatible membrane coupled to said structure, a hub positioned proximally to the implant and coupled to said membrane, one, two, or more holes or perforations along the edge of said membrane proximally, and a ventricular protrusion coupled to an anchoring device. The implant may be folded for delivery via a percutaneous catheter. The shape memory structure may include a shape memory spine, such as nitinol or, for example, PEEK. A portion of the ventricular protrusion, such as the distal tip, may be radiopaque. The anchoring device may be active or passive. The spine may include components such as micropores and microhoops for connection to said membrane and tissue.

[0020] This document also discloses a controllable catheter comprising one or more of a controllable shaft and a rotatable handle, the rotatable handle being coupled to a traction wire disposed within the shaft to adjust the bending radius of a distal tip of the shaft according to the amount of torque applied to the handle. In some embodiments, the diameter of the handle of the catheter is equal to or not greater than the diameter of the controllable shaft. This document also discloses a delivery catheter comprising one or more of the following: a rotatable handle coupled to a traction wire disposed within a torqueable shaft to adjust the bending radius of a distal tip of the shaft of the catheter; a sheath designed to receive the implant when the implant is folded; and a distal tip, the distal tip further comprising a locking member enabling the delivery catheter to connect to a hub of the implant or to an anchor. In some embodiments, the catheter may also include a tearable disposable funnel to assist in folding the implant. In some embodiments, the distal tip further includes a locking tongue that is naturally positioned in an unlocked position. The delivery catheter may be coupled to the annular hub of the implant, which has a locking tongue that receives the delivery catheter. In some embodiments, a guide wire or other catheter may be inserted within the shaft to push the locking tongue against a mating part on the hub of the implant, thereby locking the catheter and the hub. The catheter may also include a ring, such as a wire extending from a proximal stem to a distal tip, such that tension in the ring can be controlled via a control on the stem. The delivery catheter may be coupled to the annular hub of the implant, which has a cross pin. A guide wire or other catheter may be inserted within the shaft, and the wire ring is pulled against the cross pin and the guide wire until tension on the ring is maintained, thereby locking the delivery catheter to the hub of the implant.

[0021] The implant can be operatively coupled to tissue, such as cardiac tissue, via a first coupling of the anchor to the delivery catheter and a second coupling of the anchor to the implant centrality (where torque is applied to the delivery catheter to insert the anchor into the centrality and tissue). The first coupling can be decoupled to retract the catheter.

[0022] In some implementations, the commissure anchor can be delivered via one or more of the following steps: coupling the anchor to the shaft of the catheter, advancing the anchor and the catheter to the anchoring site, delivering the anchor to engage the implant and tissue, and decoupling the anchor from the shaft. The shaft may be torque-applicable, and the engagement mechanism may apply torque to the shaft to engage the anchor with the implant and tissue. The anchor may be made of a shape memory material and can be compressed into the shaft of the catheter for delivery to the anchoring site, wherein the distal tip of the catheter is shaped to pierce the tissue. The anchor can be advanced after the delivery catheter first pierces the tissue, and then the catheter is retracted, leaving the anchor in place.

[0023] In some embodiments, an implant for treating valvular regurgitation is disclosed. The implant may include one or more of the following: a removable shape memory structure, a biocompatible membrane coupled to the structure, a centrally located portion of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular protrusion coupled to an anchoring device. The implant may also include at least one pathway, such as a pathway placed around the annular margin and / or along the ventricular protrusion. In some embodiments, multiple, such as two, three, four, five, or more anchors are delivered to couple the implant to cardiac tissue. The delivery device may have a distal segment including one, two, or more anchors rotatably coupled to a central rotation axis. A spring-supported mechanism may apply thrust to cause the anchors to disengage distally. In some embodiments, the anchors may be housed in a housing with grooves on the inner diameter such that the anchors can disengage distally when the central rotation axis rotates. The device may include one or more of the following, for example: a hollow shaft, a pointed end at the end of the hollow shaft, one, two or more hollow barrels placed inside the hollow shaft through which a metal wire passes, and a push rod at the proximal end such that when a force is applied to the push rod, the barrels leave the hollow shaft one after another.

[0024] In some embodiments, this document discloses a controllable guidewire comprising an elongated flexible body having a longitudinal axis, a proximal end, and a distal deflection region; a control member at the proximal end for controllable deflection of the deflection region; and a movable deflection element extending from the control member toward the deflection region. In some embodiments, no portion of the guidewire has an outer diameter greater than about 10 French, 8 French, 6 French, or 4 French. The control member may have an outer diameter not greater than the outer diameter of the body. Rotation of the control member about the axis can cause lateral movement of the deflection region. Rotation of the control member about the axis in a first direction can cause proximal retraction of the deflection element.

[0025] This document also discloses an implantable occlusion aid device, comprising a flexible body; a first concave surface on the body configured to restrict the posterior leaflet; a second concave surface on the body configured to contact the anterior leaflet; an arcuate upper peripheral edge on the body defining an opening facing away from the first surface; and a ventricular protrusion extending away from the body and configured to be anchored in the ventricle. The device may further include an anchor on the ventricular protrusion. The anchor may be active or passive. The device may further include a flexible ridge for supporting the arcuate upper peripheral edge. In some cases, the ridge may be removable.

[0026] This document also discloses an anchoring system for attaching a ventricular protrusion to an implantable occlusal device. The system may include: a shoulder having an aperture extending through it; a helical tissue anchor extending distally from a central portion; a first engagement structure on the anchor for releasably engaging a torque shaft; a second engagement structure on the torque shaft for engaging the anchor; and an implant having a central portion sized to receive the helical anchor through which it passes; wherein the torque shaft is configured to rotate to drive the helical anchor into tissue and secure the implant to the tissue. The first engagement structure may be an aperture, and the second engagement structure may be a protrusion. The protrusion may be laterally movable in and out of the aperture, such as in response to axial movement of an elongated element within the torque shaft.

[0027] In some embodiments, a controllable guidewire is provided. The controllable guidewire may include an elongated, flexible body having a longitudinal axis, a proximal end, and a distal deflection region. The controllable guidewire may include a control at the proximal end for controllable deflection of the deflection region. The controllable guidewire may include a movable deflection element extending from the control to the deflection region. In some embodiments, no portion of the guidewire has an outer diameter greater than about 10 Frenchies. In some embodiments, no portion of the guidewire has an outer diameter greater than about 6 Frenchies. In some embodiments, no portion of the guidewire has an outer diameter greater than about 4 Frenchies. In some embodiments, the outer diameter of the control is not greater than the outer diameter of the body. In some embodiments, rotation of the control about the axis causes lateral movement of the deflection region. In some embodiments, rotation of the control about the axis in a first direction causes proximal retraction of the deflection element.

[0028] In some embodiments, an implantable occlusion assist device is provided. The implantable occlusion assist device may include a flexible body portion. The implantable occlusion assist device may include a first concave surface on the body portion, the first concave surface being configured to restrict the posterior leaflet. The implantable occlusion assist device may include a second concave surface on the body portion, the second concave surface being configured to contact the anterior leaflet. The implantable occlusion assist device may include an arcuate upper peripheral edge on the body portion, the arcuate upper peripheral edge defining an opening facing away from the first surface. The implantable occlusion assist device may include a ventricular protrusion extending away from the body portion and configured to be anchored in the ventricle.

[0029] In some embodiments, the implantable occlusion assist device may include anchors on the ventricular protrusion. In some embodiments, the implantable occlusion assist device may include active anchors. In some embodiments, the implantable occlusion assist device may include passive anchors. In some embodiments, the implantable occlusion assist device may include a flexible ridge for supporting the arcuate peripheral edge. In some embodiments, the ridge is removable.

[0030] In some embodiments, an anchoring system is provided for attaching a ventricular protrusion of an implantable occlusal device. The anchoring system may include a shoulder having an opening extending through it. The anchoring system may include a helical tissue anchor extending distally from a central portion. The anchoring system may include a first engagement structure on the anchor for releasably engaging a torque shaft. The anchoring system may include a second engagement structure on the torque shaft for engaging the anchor. The anchoring system may include an implant having a central portion sized to receive the helical anchor through which it passes. In some embodiments, the torque shaft is configured to rotate to drive the helical anchor into tissue and secure the implant to the tissue. In some embodiments, the first engagement structure is an opening, and the second engagement structure is a protrusion. In some embodiments, the protrusion is laterally movable in and out of the opening. In some embodiments, the protrusion is laterally movable in and out of the opening in response to axial movement of an elongated element within the torque shaft.

[0031] In some embodiments, an implantable occlusion assist device is provided. The implantable occlusion assist device may include an occlusion assist body portion including a first occlusion surface and an opposite second occlusion surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and a upper edge. The implantable occlusion assist device may include a ventricular protrusion extending from the lower edge. The implantable occlusion assist device may include a first support extending through at least a portion of the occlusion assist device between the upper edge and the ventricular protrusion. The implantable occlusion assist device may include a second support extending through at least a portion of the occlusion assist body portion between the first and second lateral edges. The implantable occlusion assist device may include a passageway extending through at least a portion of the occlusion assist device, the passageway being sized to receive a maneuverable catheter therethrough. In some embodiments, the first support has a first configuration where the first support is generally straight and a second configuration where the first support is curved. In some embodiments, the first and second supports are configured to allow percutaneous insertion of the implantable occlusion assist device.

[0032] In some embodiments, the passage extends through at least a portion of the occlusion assist device between the upper edge and the ventricular protrusion. In some embodiments, the steerable catheter includes a distal tip configured to bend. In some embodiments, rotation of the steerable catheter causes the distal tip to bend. In some embodiments, the first support includes a shape memory material. In some embodiments, the first support is attached to the occlusion assist portion. In some embodiments, the occlusion assist portion includes a lumen sized to receive at least a portion of the first support. In some embodiments, the first support is removable. In some embodiments, the first support extends from the upper edge to the ventricular protrusion. In some embodiments, the passage extends through at least a portion of the occlusion assist portion between the first and second lateral edges. In some embodiments, the second support includes a shape memory material. In some embodiments, the second support is attached to the occlusion assist portion. In some embodiments, the occlusion assist portion includes a lumen sized to receive at least a portion of the second support. In some embodiments, the second support is removable. In some embodiments, the second support extends from the first side edge to the second side edge. In some embodiments, the first support is coupled to the second support. In some embodiments, the first and second supports are coupled to a removable hub that protrudes from the surface of the mating auxiliary portion.

[0033] In some embodiments, a kit is provided. The kit may include an implantable occlusion assist device. The implantable occlusion assist device may include an occlusion assist body including a first occlusion surface and an opposite second occlusion surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and a upper edge. The implantable occlusion assist device may include a ventricular protrusion extending from the lower edge. The implantable occlusion assist device may include a passageway extending through at least a portion of the occlusion assist device, the passageway being sized to receive a maneuverable catheter through the passageway. The kit may include a maneuverable catheter. In some embodiments, the maneuverable catheter is configured to pass through the mitral valve and bend toward ventricular tissue, wherein the implantable occlusion assist device is configured to be delivered toward the ventricular tissue through the maneuverable catheter.

[0034] In some embodiments, the passage extends through at least a portion of the occlusion assist device between the superior margin and the ventricular protrusion. In some embodiments, the steerable catheter includes a distal tip configured to bend. In some embodiments, rotation of the steerable catheter causes the distal tip to bend. In some embodiments, the passage extends through at least a portion of the occlusion assist body between the first and second lateral margins.

[0035] In some embodiments, a method of using an implantable occlusive assist device is provided. The method may include inserting an occlusive assist portion toward a heart valve. In some embodiments, the occlusive assist portion includes a first occlusive surface, an opposite second occlusive surface, each surface being defined by a first lateral edge, a second lateral edge, a lower edge, and a superior edge, from which a ventricular protrusion extends. The method may include manipulating a first support to cause the occlusive assist portion to assume a curved configuration. In some embodiments, the first support extends through at least a portion of the occlusive assist device between the superior edge and the ventricular protrusion. The method may include manipulating a second support to cause the occlusive assist portion to assume a curved configuration. In some embodiments, the second support extends through at least a portion of the occlusive assist portion between the first lateral edge and the second lateral edge.

[0036] In some embodiments, manipulating the first support includes releasing the occlusion aid portion from the delivery catheter. In some embodiments, manipulating the second support includes releasing the occlusion aid portion from the delivery catheter. The method may include guiding the occlusion aid portion through a maneuverable catheter. The method may include passing the maneuverable catheter from the ventricular protrusion toward the superior margin before inserting the occlusion aid portion toward the heart valve. The method may include moving a distal portion of the maneuverable catheter to bend around the posterior leaflet. The method may pass the occlusion aid through the bend of the maneuverable catheter. In some embodiments, the maneuverable catheter is removed after the ventricular protrusion engages with ventricular tissue. In some embodiments, the maneuverable catheter remains in place as the ventricular protrusion is advanced toward the ventricular tissue. The method may include removing the first support from the occlusion aid portion. The method may include removing the second support from the occlusion aid portion. The method may include engaging the ventricular protrusion with ventricular tissue. In some embodiments, the method is performed percutaneously. Brief description of the attached diagram

[0037] Figure 1A-1F The diagram schematically illustrates some tissues of the heart and mitral valve, as described in the background section and below, and how they can interact with the implants and systems described herein.

[0038] Figure 2A The illustration shows a simplified cross-section of the heart, schematically illustrating mitral valve function during diastole.

[0039] Figure 2B The illustration shows a simplified cross-section of the heart, schematically illustrating mitral valve function during cardiac systole.

[0040] Figures 3A-3B The illustration shows a simplified cross-section of the heart, schematically illustrating mitral regurgitation during systole in the presence of mitral valve leaflet insufficiency.

[0041] Figure 4A The illustration shows a stylized cross-section of the heart, illustrating mitral regurgitation in the presence of functional mitral regurgitation.

[0042] Figure 4B The illustration shows a stylized cross-section of the heart, illustrating mitral regurgitation in the case of degenerative mitral regurgitation.

[0043] Figure 5A The illustration shows the implementation scheme of the coupling auxiliary device.

[0044] Figure 5B The diagram illustrates the following: along Figure 5AThe AA support structure can have various cross sections.

[0045] Figure 5C The illustration shows various shapes of anchors at the distal end of the ventricular protrusion.

[0046] Figure 5D The illustration shows non-limiting embodiments of the engagement auxiliary device with varying sizes.

[0047] Figure 5E A table illustrating non-limiting embodiments of various variations (materials, size ranges) of the support structure is provided.

[0048] Figure 5F The illustration shows an implementation scheme for the distal end of a ventricular protrusion.

[0049] Figure 5G The diagram illustrates that the position of the engagement aid can be maintained by using the shape of the engagement aid to clamp the tibia and then the petals.

[0050] Figure 5H The illustration shows an implementation scheme in which the occlusion assist device can be fixed from the ventricular side through the posterior leaflet.

[0051] Figure 6A The diagram illustrates a controllable catheter.

[0052] Figure 6B The diagram shows Figure 6A The position of the controllable catheter in the heart.

[0053] Figure 7A The illustration shows a delivery catheter.

[0054] Figure 7B An embodiment of a locking mechanism is illustrated, which locks the delivery catheter to the valve annulus center.

[0055] Figure 7C Another embodiment of the locking mechanism is illustrated, which locks the delivery catheter to the valve annulus center.

[0056] Figure 7D The diagram illustrates the coupling of an apposition aid, a delivery catheter, and a guidewire or maneuverable catheter.

[0057] Figures 8A-8D The illustration shows how the occlusion assist device is folded, pulled into the implant sheath, and delivered to the heart via the femoral approach.

[0058] Figure 8E-8G The illustration shows how the delivery catheter and implant sheath are positioned so that the ventricular protrusion of the occlusion assist device can be anchored.

[0059] Figure 8HThe illustration shows a fully open anastomosis aid and a delivery catheter positioned above the annular center for anchoring the annular center to the annulus.

[0060] Figure 8I An embodiment of an anchor that can be used to anchor the central valve of the valve ring is illustrated.

[0061] Figure 9A The illustration shows a method for anchoring the mating auxiliary device by means of a hole in the frame of the mating auxiliary device.

[0062] Figure 9B The diagram shows Figure 9A A top view of the anchors and crossbars.

[0063] Figure 10A Another embodiment of the delivery catheter is illustrated, which has multiple lumens and a connection to an implant.

[0064] Figure 10B The diagram shows... Figure 10A The cross-section of the delivery catheter is shown.

[0065] Figure 11A -B illustrates the various alternative implementation schemes for the anchor.

[0066] Figure 11C The illustration shows a delivery tube through which anchors 11A and 11B can be delivered.

[0067] Figure 11D The diagram illustrates the process after anchoring. Figure 11B How can the anchors look?

[0068] Figure 12 The illustration shows a spineless implant design (shown as structure 1220 in the figure, which is later removed from the implant).

[0069] Figure 13A -B illustrates the initial stage of the delivery procedure for invertebrate implants.

[0070] Figure 14A -B illustrates various types of anchoring methods for invertebral implants.

[0071] Figure 15A The illustration shows an implementation of an anchoring conduit capable of delivering multiple anchors. The figure also illustrates several anchor designs.

[0072] Figure 15B The illustration shows another embodiment of the anchoring conduit, which enables the delivery of multiple anchors.

[0073] Figure 15C-D illustrates how anchors in 15B can be coupled to the organization.

[0074] Figure 16A The illustration shows another embodiment of the anchoring conduit, which enables the delivery of multiple anchors.

[0075] Figure 16B -C is illustrated. Figure 16A How can the tools in the document be used to deliver multiple anchors?

[0076] Figure 17A The illustration shows another implementation scheme for the spinal cordless implant.

[0077] Figure 17B -E is illustrated in the diagram. Figure 17A How can the implementation plan be anchored?

[0078] Detailed Explanation

[0079] The devices, systems, and methods described in this disclosure are generally intended for treating mitral regurgitation (MR). Mitral regurgitation occurs when the mitral valve fails to prevent blood from flowing back from the left ventricle to the left atrium during systole. The mitral valve consists of two leaflets, anterior and posterior, which mate or meet during systole to prevent backflow. There are generally two types of mitral regurgitation: functional regurgitation and degenerative regurgitation. Functional MR is caused by a variety of mechanisms, including abnormal or damaged left ventricular (LV) wall motion, left ventricular dilation, and papillary muscle disorders. Degenerative MR is caused by structural abnormalities of the valve leaflets and subvalvular tissue, including stretching or rupture of the chordae tendineae. Damaged chordae tendineae can lead to leaflet prolapse, meaning the leaflet protrudes (usually into the atrium), or, if the chordae tendineae are torn, the leaflet becomes a flail, causing backflow of blood. As described below, the devices, systems, and methods of this disclosure naturally provide a new mate surface above the leaflets to minimize or eliminate backflow of blood.

[0080] See Figure 1A-1D The image shows the four chambers of the heart: left atrium 10, right atrium 20, left ventricle 30, and right ventricle 40. The mitral valve 60 is positioned between the left atrium 10 and left ventricle 30. The tricuspid valve 50 (which separates the right atrium 20 and right ventricle 40), aortic valve 80, and pulmonary valve 70 are also shown. The mitral valve 60 consists of two leaflets (anterior leaflet 12 and posterior leaflet 14). In a healthy heart, the edges of the two leaflets are opposite each other at the occlusal zone 16 during systole.

[0081] The fibrous valve annulus 120, as part of the cardiac frame, provides attachment to the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14. The leaflets are axially supported by attachment to chordae tendineae 32. These chordae tendineae are in turn attached to one or both of the papillary muscles 34 and 36 of the left ventricle. In a healthy heart, these chordae tendineae support structures tether the mitral valve leaflets, allowing them to open easily during diastole but to withstand the high pressure that develops during ventricular systole. In addition to the tethering effect of the support structures, the shape and tissue consistency of the leaflets contribute to effective sealing or occlusion. The leading edges of the anterior and posterior leaflets meet at the occlusion zone 16, where a cross-section 160 of the three-dimensional occlusion zone (CZ) is schematically shown. Figure 1E middle.

[0082] The anterior and posterior mitral valve leaflets have different shapes. The anterior leaflet is more firmly attached to the annulus covering the central fibrous body (cardiac strut) and is slightly stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80% of the closure area is the anterior leaflet. In cases where the mitral annulus fuses with the base of the non-coronary cusp of the aorta, the fibrous triangular ridges formed on the left (lateral) 124 and right (septal) 126 are located adjacent to the commissures 110 and 114, above or anterior to the annulus 120. Figure 1F Fiber triangular prisms 124 and 126 form the septal and lateral extensions of the central fibrous body 128. In some embodiments, fiber triangular prisms 124 and 126 may have advantages such as providing a robust region for stable engagement with one or more annular archors or atrial archors. The occlusion zone CL between leaflets 12 and 14 is not a simple line, but a curved, funnel-shaped surface interface. The first 110 (lateral or left-side) and second 114 (septal or right-side) commissure is where the anterior leaflet 12 and the posterior leaflet 14 meet at the annulus 120. Figure 1C , 1D Most clearly visible in the axial view of the atrium at 1F, the axial section of the choking zone typically shows a curved line CL, which is separated from the centroid of the valve annulus CA and from the opening through the valve during diastolic CO. Furthermore, the leaflet edges are serrated, especially the posterior leaflet compared to the anterior leaflet. Regurgitation can occur between one or more of these AP (anterior-posterior) segment pairs A1 / P1, A2 / P2, and A3 / P3, causing the regurgitation characteristics to vary along the curve of the choking zone CL.

[0083] Now see Figure 2A In proper cardiac function, the mitral valve 60 is open during diastole to allow blood to flow along the pathway FP from the left atrium to the left ventricle 30 and thereby fill the left ventricle. (As in...) Figure 2BAs shown, by increasing ventricular pressure, first passively and then actively, the mitral valve 60, which functions, closes during systole and effectively separates the left ventricle 30 and the left atrium 10, thereby allowing the cardiac tissue surrounding the left ventricle to contract and thus propel blood through the vascular system.

[0084] See Figures 3A-3B In cases 4A-4B, several conditions or disease states exist in which the edges of the mitral valve leaflets do not come together adequately, thus allowing blood to flow back from the ventricles to the atria during systole. Regardless of the specific cause in a particular patient, the inability of the leaflets to seal properly during ventricular systole is called regurgitation and causes mitral regurgitation.

[0085] Typically, insufficiency can be caused by excessive tethering of one or two leaflets to their supporting structures, or by excessive stretching or tearing of these structures. Other less common causes include valvular infection, congenital abnormalities, and trauma. Valvular dysfunction can be caused by: stretching of the chordae tendineae (known as mitral valve prolapse), and in some cases, tearing of chordae tendineae 215 or papillary muscles (known as flail leaflet 220), as in... Figure 3A As shown in the diagram. Alternatively, if the leaflet tissue itself is superfluous, the valve may prolapse to the level of occlusion in the atrium, opening the valve higher in the atrium during ventricular systole. Either leaflet may prolapse or become flail-like. This condition is sometimes called degenerative mitral regurgitation.

[0086] In such Figure 3B In the excessive tethering illustrated, the leaflets of a structurally normal valve may fail to function properly due to annular enlargement or shape alteration (so-called annular dilatation 240). This type of functional mitral regurgitation is typically caused by myocardial failure and associated ventricular dilatation. Furthermore, the excessive volume overload caused by functional mitral regurgitation itself may exacerbate heart failure, ventricular and annular dilatation, and thus worsen mitral regurgitation.

[0087] Figures 4A-4B The diagram illustrates functional mitral regurgitation during systole. Figure 4A ) and degenerative mitral regurgitation ( Figure 4B The return of blood in BF. Figure 4A The increased size of the middle valve annulus, coupled with increased tethering due to hypertrophy of the ventricular 320 and papillary muscles 330, prevents the anterior leaflet 312 and posterior leaflet 314 from opposing each other, thus preventing occlusion. Figure 4B In this case, tearing of chordae tendineae 215 causes the posterior leaflet 344 to detach upwards into the left atrium, preventing its repositioning with the anterior leaflet 342. In either case, the result is blood returning to the atrium, which reduces the effectiveness of left ventricular compression.

[0088] Figure 5A An embodiment of the occlusion assist device 500 is illustrated. The occlusion assist device 500 may include an occlusion assist body 515. The occlusion assist body 515 may include a first occlusion surface 535. The first occlusion surface 535 may be arranged toward the incompletely closed natural leaflet, and in the case of the mitral valve, toward the posterior leaflet upon implantation. The occlusion assist body 515 may include a second occlusion surface 540. The second occlusion surface 540 may be opposite to the first occlusion surface 535, such as... Figure 5A As shown in the diagram. The second occlusal surface 540 may be positioned toward the incompletely closed natural leaflet, or, in the case of the mitral valve, toward the anterior leaflet upon implantation. The first occlusal surface 535 and the second occlusal surface 540 may be bounded by a first lateral edge and a second lateral edge. The first occlusal surface 535 and the second occlusal surface 545 may be bounded by a lower edge and a upper edge 545.

[0089] The first occlusive surface 535 and the second occlusive surface 540 are two sides of the same implant structure forming the occlusive aid portion 515. In some embodiments, the shape of the occlusive aid portion 515 may generally be characterized by the shape of the upper edge 545 and the shapes of the first occlusive surface 535 and the second occlusive surface 540.

[0090] The valvular support device 500 may include a ventricular protrusion 525, such as Figure 5A As shown in the diagram. A ventricular protrusion 525 can extend from the lower edge of the occlusion aid portion 515. The ventricular protrusion 525 can be placed within the left ventricle upon implantation. The ventricular protrusion 525 can provide an anchoring mechanism. The distal end 530 of the ventricular protrusion 525 typically provides an anchoring mechanism.

[0091] The distal end 530 of the ventricular protrusion 525 can have different shapes, such as Figure 5C As shown in the image. Figure 5C Five implementations of the remote 530 are shown. Note that there may be many more variations, and these variations are not limited to... Figure 5C The five implementation schemes are shown. Typically, and in other implementations, there are two types of anchors. Examples of passive anchors are shown... Figure 5C Implementation schemes 555.1 to 555.4 in the text. Passive anchors rely on entrapment behind the chordae tendineae and / or interference with the chordae tendineae. Regarding passive anchors, in some implementations, the maximum size or the size responsible for wrapping the chordae tendineae (typically the width) can be 10mm-40mm, such as 25mm.

[0092] The distal end 555.1 includes one or more tips. The tips may be elongated rods extending from the central hub, as shown. In the illustrated embodiment, four tips extend from the central hub. In other embodiments, one or more tips extend from the central hub. The tips may extend at an angle to the central hub, thereby increasing the surface area of ​​the distal end 530. The distal end 555.2 may be generally rectangular, rectangular, generally square, square, generally rhomboid, or rhomboid. The distal end 555.2 may include one or more cutouts. Cutouts can increase the ability to grip tissue. In the illustrated embodiment, four cutouts are formed in the distal end. In other embodiments, one or more cutouts are provided.

[0093] The distal end 555.3 includes one or more tips. The tips may be elongated rods extending from the central hub, as shown. In the illustrated embodiment, two tips extend from the central hub. In other embodiments, one or more tips extend from the central hub. The tips may extend at right angles to the central hub, thereby increasing the surface area of ​​the distal end 530.

[0094] The distal end 555.4 includes one or more barbs. The barbs may extend from the central hub as shown. The barbs may also retract towards the central hub. In the illustrated embodiment, three or more barbs extend from the central hub. In other embodiments, one or more barbs are arranged in one or more directions.

[0095] The distal end 555.5 includes one or more tips and has a configuration similar to that shown in the distal end 555.1. The distal end 555.5 is an example of an active anchor. An active anchor may have components such as tips, barbs, or screws that can be coupled to ventricular tissue. An active anchor may require a driving force, such as torque, to embed into the tissue. Passive or active anchors may be made of implant-grade biocompatible materials such as silicone, PEEK, Pebax, or polyurethane.

[0096] The dimensions of the coupling auxiliary device 500 are described in detail in Figure 5D The figure shows a top view and a front view of the engagement assist body 515 of the engagement assist device 500. The three parameters “x”, “y”, and “z” shown in the figure characterize the engagement assist device 500. Non-limiting examples of the range and size of these variables x, y, and z are shown in the “Dimension Table” in the figure.

[0097] The mating aid 500 may include a support structure 505. The support structure 505 may be referred to as a ridge. The support structure 505 may at least partially define the shape of the mating aid 500.

[0098] Return to Figure 5AThe support structure 505 is shown by dashed lines. In some embodiments, the support structure 505 is made of shape memory materials such as, but not limited to, nitinol (NiTi), polyetheretherketone (PEEK), or other rigid polymers or fatigue-resistant metals. The use of shape memory materials enables the advantages described herein. For example, one advantage of shape memory materials is that their hyperelastic properties help the collision assist device 500 maintain its shape and functionality as a collision assist device when the heart contracts and expands and applies pressure to it. Another example of this advantage is that shape memory materials are suitable for the percutaneous delivery methods described herein.

[0099] The support structure 505 may include one or more segments. In some embodiments, the support structure 505 includes one segment. In some embodiments, the support structure 505 includes two segments. In some embodiments, the support structure 505 includes three or more segments. In some embodiments, one or more segments of the support structure 505 may include one or more sub-segments. Figure 5A In the embodiment shown, the support structure 505 includes two segments: a first segment 505.2 and a second segment 505.1.

[0100] The first segment 505.2 may extend between the upper edge 545 and the ventricular protrusion 525 through at least a portion of the occlusion assist device 500. In some embodiments, the first segment 505.2 may extend between the upper edge 545 and the ventricular protrusion 525 along the entire length of the occlusion assist device 500. In some embodiments, the first segment 505.2 extends from a position between the upper edge 545 and the lower edge of the occlusion assist body 515. In some embodiments, the first segment 505.2 extends from a position between the lower edge of the occlusion assist body 515 and the ventricular protrusion 525. In some embodiments, the first segment 505.2 extends along the occlusion assist body 515 and continues to support the ventricular protrusion 525.

[0101] The second segment 505.1 may extend between the first and second side edges, passing through at least a portion of the mating aid portion 515. In some embodiments, the second segment 505.1 may extend over the entire length between the first and second side edges. In some embodiments, the second segment 505.1 extends from a position between the upper edge 545 and the lower edge of the mating aid portion 515. In some embodiments, the second segment 505.1 extends from a position closer to the upper edge 545 than the lower edge of the mating aid portion 515. In some embodiments, the second segment 505.1 extends from the first side edge toward the second side edge. In some embodiments, the second segment 505.1 extends from the second side edge toward the first side edge. In some embodiments, the second segment 505.1 extends along a segment between the first and second side edges. In some embodiments, the second segment 505.1 extends along an edge of the mating aid 500.

[0102] In some embodiments, the first segment 505.2 and the second segment 505.1 of the support structure 505 can be a single integral piece or a monolithic structure. In some embodiments, the first segment 505.2 and the second segment 505.1 of the support structure 505 are separate components. In some embodiments, the first segment 505.2 and the second segment 505.1 can be two separate segments joined together by methods such as, but not limited to, crimping and laser welding.

[0103] In some embodiments, the first segment 505.2 is integrated within the occlusal support body 515 as described herein. In some embodiments, the first segment 505.2 is integrated within the ventricular protrusion 525 as described herein. In some embodiments, the first segment 505.2 is removable from the occlusal support body 515 as described herein. In some embodiments, the first segment 505.2 is removable from the ventricular protrusion 525 as described herein. In some embodiments, the second segment 505.1 is integrated within the occlusal support body 515 as described herein. In some embodiments, the second segment 505.1 is removable from the occlusal support body 515 as described herein. In some embodiments, the first segment 505.2 may have a first region and a second region, the first region being oriented substantially parallel to the longitudinal axis of the body 515, and the second region being oriented substantially perpendicular to the longitudinal axis of the body 515, as illustrated.

[0104] The support structure 505 supporting the shape of the ventricular protrusion 525 can have, for example, the shape of the support structure 505 supporting the ventricular protrusion 525. Figure 5A Various cross sections are shown in section AA and illustrated in detail. Figure 5B In. Figure 5BFive embodiments of the cross-section are shown; however, it should be noted that the embodiments of the cross-section of the support structure 505 are not limited to these five. Cross-section 550.1 is circular or substantially circular. Cross-section 505.2 is circular or substantially circular. Cross-section 550.1 may have a larger cross-sectional area than cross-section 550.2. Cross-section 550.3 comprises multiple circular or substantially circular cross-sections. In the illustrated embodiment, seven circular or substantially circular cross-sections collectively form cross-section 550.3. In other embodiments, two or more circular or substantially circular cross-sections collectively form cross-section 550.3. Cross-section 550.3 may be in the form of a cable. Cross-section 550.4 is rectangular or substantially rectangular. Cross-section 550.5 is rectangular or substantially rectangular. Cross-section 550.4 may have a larger cross-sectional area than cross-section 550.5.

[0105] It should also be noted that the first segment 505.2 and the second segment 505.1 may have different cross sections. Figure 5B Each cross-section or embodiment shown may have certain advantages, such as some cross-sections being easily bent in one direction and not easily bent in another. Some other cross-sections may have higher reliability properties than others. The characteristics of each type of cross-section are described for both NiTiNo and PEEK materials. Figure 5E The range of cross-sections and non-limiting possible dimensions are shown in Table 2. Although various configurations are presented in Table 2, in some embodiments, cross-sections of 550.4 and 550.5 can be used for both materials.

[0106] When the occlusion assist device 500 is placed inside the heart, in some embodiments, the occlusion assist device 500 causes the ventricular protrusion 525 to be substantially placed in the left ventricle, such as... Figure 5G As shown in the diagram. The ventricular protrusion 525 provides a mechanism for using the structural anchoring of the ventricle to secure the occlusion aid 500. An example of positioning the occlusion aid 500 above the posterior leaflet is illustrated in the diagram. Figure 5G middle.

[0107] It should be remembered that other instances of positioning are possible and discussed elsewhere in this disclosure; in this particular embodiment, an occlusion aid 500 with a curved ventricular protrusion 525 is illustrated. The ventricular protrusion 525 and / or the first support 505.2 may be made of a shape memory material, in which case it retains its curved shape after implantation. The curved shape allows the occlusion aid 500 to remain in place after engagement with the natural valve leaflet 14.

[0108] Figure 5FAn embodiment of a passive anchor for a ventricular protrusion 525 is shown. In this embodiment, a tube 560 traveling along the length of the ventricular protrusion 525 terminates at the distal end of an engagement aid 500 at two tubes 565.1 and 565.2. The engagement aid 500 can be delivered to the left side of the heart using a straightened wire such that the two tubes 565.1 and 565.2 are approximately straight, as shown by dashed lines 565.1 and 565.2 (position A), indicating that the straightened wire is in an advanced state. In some embodiments, the two tubes 565.1 and 565.2 can be made of a shape memory material, including but not limited to polyurethane, silicone, polyethylene, pebax, and nylon. In the absence of a straightened wire, the two tubes 565.1 and 565.2 can have a default shape, which can be coiled or coiled, such as... Figure 5F The solid lines 565.1 and 565.2 are shown in the figure (position B).

[0109] After the implant is properly delivered and placed in the heart, the straightened wire can be retracted, allowing the two tubes 565.1 and 565.2 to take their default shape (position B). The two tubes 565.1 and 565.2 provide anchoring support due to their entanglement with the chordae tendineae. The advantage of this type of anchoring is that if unsatisfactory placement necessitates repositioning of the occlusion aid 500, the straightened wire can be pushed back into the two tubes 565.1 and 565.2, straightening them and causing them to disengage from the chordae tendineae structure. Although the above embodiment describes two tubes 565.1 and 565.2, it should be understood that one, two, or more tubes may be present.

[0110] exist Figure 5H The figure illustrates yet another embodiment of the anchoring occlusion assist device 500. An active anchor can be coupled to the distal end of the ventricular protrusion 525. After implant delivery, the active anchor can be driven through the posterior leaflet to couple to the occlusion assist device 500 at the valve annulus (atrium) segment as shown. Methods for positioning and driving the anchor will be discussed herein.

[0111] In another embodiment, the tip of the ventricular protrusion 525 may be radiopaque or echogenic, thereby assisting in the placement and anchoring of the occlusion assist device 500 during percutaneous placement. In such a procedure, fluorescence or ultrasound imaging modalities can be used to visualize the heart and the occlusion assist device 500.

[0112] Return to Figure 5AIn another embodiment, the occlusion assist device 500 may include a hub 510. The hub 510 may have one or more purposes. One purpose may be to act as an anchoring device as discussed herein. Another purpose may be to provide a mechanism for percutaneous delivery of the occlusion assist device 500 as discussed herein. In some embodiments, the hub (not shown) may be present at the distal end of the occlusion assist device 500. The hub may be located at the distal end of the ventricular protrusion 525. The ventricular hub may be located at the distal tip of the distal end 530 of the ventricular protrusion 525. To distinguish the two hubs, the hub 510 on the proximal side will simply be referred to as the “hub,” “annular hub,” or “proximal hub.” The hub at the distal tip of the ventricular protrusion will be specifically referred to as the “ventricular hub.”

[0113] Also refer to Figure 5A The closure assist body 515 of the closure assist device 500 can be made of a variety of biocompatible materials, such as expanded polytetrafluoroethylene (ePTFE). This material provides a closure surface against which the anterior leaflet will close. The closure assist body 515 of the closure assist device 500 can be coupled to a support structure 505 such that the shape of the support structure 505 imparts a general shape to the closure assist device 500.

[0114] The shape of the mating aid 500 can be further supported by one or more ribs 546 (not shown). One, two, or more ribs 546 may be present. The ribs 546 may be made of a variety of materials, such as, but not limited to, sutures, polypropylene, nylon, NiTi cables, NiTi filaments, and PEEK. This document describes the process of coupling the mating aid body 515 of the mating aid 500 to the support structure 505 and / or the ribs 546 (if present).

[0115] In some manufacturing methods, the process can be initiated by sliding a polyethylene (PE) tube onto a support structure 505 and / or ribs 546 (if ribs 546 are present). This assembly is placed between two ePTFE sheets, followed by the application of heat and pressure. Due to the pores in the ePTFE material, the ePTFE bonds to the PE tube, and the polyethylene material of the tube can melt into the pores in the ePTFE material, forming a mechanical bond. Similarly, when heat and compression are applied, the PE tube material can melt into the micropores in the support structure 505 and / or ribs 546. Careful placement of the micropores in the support structure 505 and / or ribs 546 can improve adhesion.

[0116] In a variation of the above process, a PE sheet can be placed, eliminating the need for a PE tube. In this variation, as described above, a simple process of heating and compression is applied, resulting in a more uniform composite structure. In a further embodiment, the support structure 505 and / or ribs 546 may have components such as micropores coupled to the ePTFE membrane. The micropore diameter can be, for example, in the range of 0.005” to 0.030”.

[0117] In variations concerning the material type that can be used to prepare the aligning auxiliary body 515 of the aligning auxiliary device 500, other materials such as, but not limited to, sponge materials, polyurethane, silicone, bovine or porcine pericardium can be used. The bonding process can include, but is not limited to, thermal bonding, sewing, and gluing.

[0118] Continue to refer to Figure 5A In some embodiments, the mating aid 500 has perforations or slots 520. One or more such perforations or slots 520 may be present. These perforations 520 may serve the purpose of providing a location for anchoring fasteners, as discussed herein.

[0119] One advantage of the occlusion assist device 500 is that it can be folded into a smaller structure. The occlusion assist device 500 can be delivered percutaneously via a delivery catheter. In some embodiments, the support structure 505 is made of a shape memory material. When the occlusion assist device 500 deploys within the heart, it regains its desired shape. Numerous embodiments now describe various methods, devices, and systems for delivering the occlusion assist device 500 into the heart.

[0120] In some methods of use, the first support has a first configuration in which the first support 505.2 is generally straight, and a second configuration in which the first support 505.2 is curved. In some methods of use, the first support 505.2 and the second support 505.1 are configured to allow percutaneous insertion of the engagement aid 500.

[0121] The initial steps in the delivery procedure can be similar to those known in the art. For example, a puncture is made in the lower trunk / upper thigh region (groin) to obtain access to the femoral vein. Typically, a trans-spetal sheath and needle are inserted into the inferior vena cava and advanced up to the interatrial septum, where a transventricular septal puncture is performed, and the trans-spetal sheath is advanced into the left atrium. The needle is removed, and the trans-spetal sheath now provides access to the left atrium. Further details regarding the above steps can be found in public medical literature.

[0122] The method may include various steps, including those now described. The ventricular protrusion 525 of the occlusion assist device 500 can be generally placed in the left ventricle. It can be advantageous to guide the occlusion assist device 500 to this position using various guidance techniques. For example, a simple guidewire can be placed within the transseptal sheath and guided into the left ventricle by first entering the left atrium and passing through the mitral valve. However, a simple guidewire may not provide sufficient accuracy in the placement of the ventricular protrusion 525.

[0123] In some implementations, a method of placing a guidewire within a manipulable sheath can be used. The manipulable sheath with the guidewire can be advanced across the septal sheath and subsequently through the mitral valve into the left ventricle, where the manipulability of the sheath provides additional support for proper positioning of the guidewire. After guidewire placement, the manipulable sheath needs to be removed before delivery of the occlusion aid. While this method provides more accurate positioning of the guidewire, it involves an additional step of removing the manipulable sheath. To improve this process by reducing the number of steps required to perform implantation, several implementations of manipulable sheaths are disclosed herein.

[0124] Small diameter maneuverable catheter

[0125] Reference Figure 6A The illustration shows a small-diameter maneuverable catheter 600. In some embodiments, the diameter 615 of the handle 610 of the maneuverable catheter 600 may be equal to or substantially equal to the diameter 620 of the body 605 of the maneuverable catheter 600. The maneuverable catheter 600 may have a traction line 625 within it. When the handle 610 is rotated, for example in the direction of arrow 632, the distal portion of the maneuverable catheter 600 moves along arrow 635 from a straight position 630 to a curved position 640. The curved position 640 can be advantageous for locating the ventricular protrusion 625, as discussed herein. When the handle 610 is rotated, for example in the opposite direction of arrow 632, the distal portion of the maneuverable catheter 600 moves along the curved position 640 to a straight position 630. The straight position 630 of the maneuverable catheter 600 is shown by a dashed line and should not be confused with the traction line 625, which is also shown by a dashed line. The straight position 630 can be advantageous for anatomically inserting or withdrawing the maneuverable catheter 600.

[0126] In some embodiments, the diameter of the handle 610 may be equal to the diameter of the body 605. This can be advantageous because the occlusion aid 500 can slide across the handle 610 and / or the body 605 after the maneuverable catheter 600 is placed in the ventricle. In some embodiments, the maneuverable catheter 600 may include an extension 612 extending proximally from the handle 610. The extension 612 may be a wire or other elongated structure. The purpose of the extension 612 is to assist in loading other catheters or devices while allowing clinicians or other operators to maintain control of the maneuverable catheter 600. After other catheters or devices are loaded onto the extension 612, the maneuverable catheter 600 is used to guide the other catheters or devices. The length of the extension 612 may match or exceed the length of the loaded catheter or device to maintain control of the maneuverable catheter 600 during the loading and delivery of other catheters or devices.

[0127] In some implementations, the extension 612 may be coupled to the handle 610 only when necessary. For example, if the medical team determines during operation that a longer catheter is necessary, the extension 612 may be coupled to the handle 610. The coupling mechanism may include, but is not limited to, threaded connections, press-fits, or other mechanisms.

[0128] In some embodiments, non-limiting examples of the dimensions of the various sub-components (body 605, handle 615, extension 612) may be as follows: the diameter 620 of the body 605 may range from 2 to 10 Fr, such as 4 Fr, about 2 Fr to about 6 Fr, about 3 Fr to about 5 Fr, or less than 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, or 2 Fr. In some cases, the length of the handle 610 may be about 1 / 2” to about 2”, such as about 1”, and the range of the handle's linear travel (for starting the traction line) may be about 1 / 8” to about 3”, such as about 1 / 4”.

[0129] During the implantation procedure, some methods involve a guide wire or a guide wire and a manipulable sheath. In some methods, the manipulable catheter 600 can be advanced via a femoral approach. Because the stem 610 is external to the patient's body, it can be rotated so that the distal portion of this manipulable catheter 600 is positioned appropriately below the posterior leaflet. An extension 612 can be attached to the proximal end of the stem 610, thereby allowing subsequent loading of the occlusion aid 500 and delivery catheter 700, which is then inserted into the transseptal sheath 650, as described herein. This delivery catheter 700 can then be used as a guide for introducing the occlusion aid 500, as will be explained herein.

[0130] Figure 6BThe illustration shows the placement of a maneuverable catheter 600 in the heart. An embodiment across the septal sheath 650 is shown. The left atrium 655, left ventricle 660, posterior leaflet 665 of the mitral valve, and anterior leaflet 670 of the mitral valve are also shown. The maneuverable catheter 600 is shown passing through the mitral valve and positioned below the posterior leaflet 665. It is now understood that having the ability to deflect the distal portion of the maneuverable catheter 600 can be advantageous in achieving a suitable position for the occlusion assist device 500. The distal portion of the maneuverable catheter 600 is capable of bending below the posterior leaflet 665 as shown. In some methods, the next common step after placement of the maneuverable catheter 600 is delivery of the occlusion assist device 500 to the heart. Further embodiments regarding methods and apparatus for achieving delivery are now described.

[0131] Delivery catheter

[0132] Reference Figure 7A The delivery catheter 700 is now described. The function of the delivery catheter 700 is to carry the occlusion assist device 500 to the heart. The shaft 710 of the delivery catheter 700 may be torque-applicable and deflectable. The shaft 710 is shown by cross-shading. The delivery catheter 700 may include a handle 730. The handle 730 may have a rotating mechanism, such as a traction wire, etc. The rotating mechanism can deflect and manipulate the shaft 710. Distal to the handle 730 is an implant sheath 725, which, as explained herein, can carry the occlusion assist device 500 to the heart. In some embodiments, and even further distal to the implant sheath 725, is a tear-away funnel 720. The tear-away funnel 720 can facilitate the folding of the occlusion assist device 500. In some embodiments, the most distal end of the shaft 710 has a component that can lock the shaft 710 to the occlusion assist device 500 so that the occlusion assist device 500 can be transported to the heart and properly placed. Now about Figure 7B , 7C The 7D description describes the locking process and components.

[0133] Reference Figure 7D The delivery catheter 700 and the occlusion aid 500 may have a matching feature that enables them to be temporarily locked. In some embodiments, the delivery catheter 700 includes one or more distal locking tongues 705. The occlusion aid 500 may include a valve annular center 510 as described herein. The distal locking tongue 705 of the delivery catheter 700 may be coupled to a component in the valve annular center 510 of the occlusion aid 500, as will be explained herein.

[0134] In some methods, the maneuverable catheter 600 or other guidewire or catheter can be advanced through the ventricular protrusion 525 and / or anchoring mechanism 530. In some embodiments, the anchoring mechanism 530 may have a central hole or passage to allow the maneuverable catheter 600 to pass through, such as... Figure 7D As shown in the diagram. The controllable catheter 600 can extend from the anchoring mechanism 530 to the annular center 510. Other paths via the occlusion aid 500 are anticipated. The controllable catheter 600 can extend from the anchoring mechanism 530 to the annular center 510 and further to the delivery catheter 700.

[0135] Reference Figure 7B The tip of the delivery catheter 700 is shown in a magnified view. The annular center 510 of the anastomosis aid 500 is also shown. The distal locking tongues 705 can be made of some shape memory material such as nitinol. The natural position of the locking tongues 705 is set such that they are curved inward and toward each other, as... Figure 7A As shown in the diagram. In some methods, a guidewire or catheter, such as a maneuverable catheter 600, can be inserted between the annular pivot 510 and the distal locking tongue 705, and the distal locking tongue 705 can be pushed out against the annular pivot 510. The annular pivot 510 is designed with mating slots 740 such that the distal locking tongue 705 fits precisely into these slots 740. As long as the maneuverable catheter 600 is present to force the distal locking tongue 705 outward into the slots 740, the tip of the delivery catheter 700 remains locked to the annular pivot 510. Other locking mechanisms are possible, and one such alternative is now described in Figure 7C middle.

[0136] Reference Figure 7C The annular pivot 510 may include a pin 745. The pin 745 may be a solid member passing through the annular pivot 510, which is secured in place by methods known in the art. The delivery catheter 700 may include a loop of wire or suture 750. The suture 750 may be looped around an object such as a guide wire within the annular pivot 510 or a maneuverable catheter 600. The suture 750 may extend into a handle 730 of the delivery catheter 700. The handle 730 may have a mechanism for controlling the tension of the suture 750. By controlling the tension, the occlusion aid 500 can be pulled against and securely fixed to the distal end of the delivery catheter 700. When the maneuverable catheter 600 is withdrawn to a level past the pin 745, the loop 755 of the suture 750 can slide over the pin 745, thereby releasing the pin 745 and the occlusion aid 500.

[0137] Delivery program

[0138] Figures 8A-8DThe delivery method is shown. In some methods, the implant sheath 725 and funnel 720 are advanced to cover the occlusion aid 500. The implant sheath 725 and funnel 720 can be advanced to cover the occlusion aid 500 after the delivery catheter 700 is locked with the occlusion aid 500. The shape of the funnel 720 assists in closing the occlusion aid 500 or folds itself in place. The advancement of the implant sheath 725 and funnel 720 is shown. Figure 8A and 8B middle. Figure 8A Arrow 760 indicates how the occlusion aid 500 is pulled into the funnel 720. Once the occlusion aid 500 is within the implant sheath 725, the funnel 720 is removed. In some embodiments, the funnel 720 is removed by pulling on the tongue 715, thereby splitting the funnel 720, as shown in the diagram. Figure 8C Then the funnel 720 and tongue 715 can be discarded. In some methods, the implant sheath 725 housing the occlusion aid 500 can be advanced through the guide wire or the maneuverable catheter 600. To reiterate, the advantages of the maneuverable catheter 600 design become apparent when the occlusion aid 500 can slide smoothly on the maneuverable catheter without any difficulty caused by the different diameters of the handle 610 and the body 605. The implant sheath 725 can be inserted into the transseptal sheath 650, as... Figure 8D As shown.

[0139] The system of the occlusion assist device 500 and the implant sheath 725 is advanced until it exits the transseptal sheath 650, as... Figure 8E As shown in the diagram. The delivery catheter 700 is deflected such that the implant sheath 725 is positioned between the leaflets of the mitral valve, as shown in the diagram. Figure 8E In the middle. The implant sheath 725 is positioned between the chordae tendineae 765 (“P2” position). Once the implant sheath 725 reaches this position, the delivery catheter 700 is held in place and the implant sheath 725 is slowly withdrawn, causing the occlusion aid 500 to begin withdrawing from the implant sheath 725, as... Figure 8F As shown in the diagram. It should be noted that the controllable catheter 600 or equivalent guidewire remains located below the posterior leaflet and can still be actively adjusted or deflected using the control handle 610. In some methods, as the delivery catheter 700 is advanced, the occlusion aid 500 is pushed out along the path of the controllable catheter 600 until it couples to the ventricular tissue at the distal end 530 of the ventricular protrusion 525. This illustration is in... Figure 8G In some methods, the delivery catheter 700 can be rotated to ensure proper placement as the occlusion aid 500 is deployed.

[0140] Anchoring

[0141] Once the occlusion assist device 500 is activated, the method may include anchoring the occlusion assist device 500 in the atrial orientation of the mitral valve, i.e., on the mitral valve annulus. Several embodiments now describe methods and systems for achieving this anchoring.

[0142] A support structure 505 made of shape memory material can be advantageous. When the occlusion aid 500 is opened, the shape desired by the occlusion aid 500 is produced by the action of the shape memory material. As described herein, the shape of the occlusion aid 500 can be intended to provide a new occlusion surface, thereby reducing or eliminating backflow. Returning to the explanation of the delivery and anchoring process, the delivery conduit 700 (which may still be coupled to the annular center 510 of the occlusion aid 500) can now be manipulated (rotationally and axially) to suitably position the occlusion aid 500 above the posterior leaflet of the natural leaflet. In embodiments, the support structure 505 of the occlusion aid 500 may have components that can be attached to the tissue. In some embodiments, these components are passive hooks. In some methods, these components engage the annulus so that the occlusion aid 500 can be held in place simultaneously with the initiation of anchoring. Figure 8H The state of the delivery catheter 700 is shown, with the implant sheath 725 withdrawn and the shaft 710 still coupled to the valve annulus center 510.

[0143] Detailed illustrations of the implementation scheme for anchor 800 are shown in [the diagram]. Figure 8I Anchor 800 can be coupled to delivery catheter 700 and / or occlusion aid 500 in various ways. Annular pivot 510 may have a pin 512. Pin 512 may provide a portion around which the helical structure 815 of anchor 800 can be wound, as shown. Anchor 800 may have a shoulder 805. Shoulder 805 may fit snugly against the shaft 710 of delivery catheter 700. Shoulder 805 may have a component such as window 810 that can lock the distal locking tongue 705 of delivery catheter 700. The distal locking tongue 705 of delivery catheter 700 can be locked when a pin, guide wire, or catheter such as controllable catheter 600 is present within the shaft 710 of delivery catheter 700. In some methods, anchor 800 may be preloaded onto occlusion aid 500 and locked in place with delivery catheter 700 during the process of installing occlusion aid 500 onto delivery catheter 700. This can occur before the occlusion assist device 500 is pulled into the implant sheath 725 and is ready for insertion into the femoral vein. Return to Figure 8HA torque can be applied to the shaft 710 to drive the anchor 800 into the tissue. To provide feedback on whether the anchor 800 is properly secured, fluorescent markers can be present on the anchor 800. These markers can be located proximally. These markers can inform the medical team approximately how far the anchor 800 can travel toward the valve annulus center 510 and approximately when the anchor 800 is securely in place. In some embodiments, to ensure that appropriate torque is applied, the torque level can reach a spike at the stem 730 when the anchor 800 reaches its lowest point on the valve annulus center 510. This increased torque level can be felt at the stem 730, providing feedback that appropriate torque has been applied. The central guidewire or controllable catheter 600 can be withdrawn. This causes the distal locking tongue 705 to retract from the window 810 of the anchor 800, thereby unlocking the delivery catheter 700 and the anchor 800. This can lead to the release of the occlusion aid 500. The delivery catheter 700 and the controllable catheter 600 can now be completely withdrawn.

[0144] Joint anchorage

[0145] Several implementation schemes illustrate the joint anchorage. One such implementation scheme is shown... Figure 9A In the middle. The delivery conduit 700 (not shown) has been withdrawn, and the anchoring conduit 900 has been advanced through the femoral access. The anchoring conduit 900 is torque-applicable. One or more anchoring conduits 900 may be provided. The distal tip of the anchoring conduit 900 may have one or more components to lock the anchor in place during anchor delivery. Figure 9A In the middle, the distal tip has a notch 905 that can receive a portion of the helical anchor 915. The anchoring conduit 900 may also have a central pin 920. The central pin 920 may have a tip on the distal tip. In some embodiments, the central pin 920 may have the ability to be withdrawn.

[0146] Figure 9A A ring 910 is shown. The end of the ring 910 (not shown) can travel to or between the handle and the portion of the length of the anchoring conduit 910 such that the tension of the ring 910 can be controlled. The ring 910 coils around the crossbar 917 or other portions forming the proximal portion of the helical anchor 915. A top view of the helical anchor 915 with the crossbar 917 is shown. Figure 9B In the middle. When outside the body, before entering the transspacer sheath (not shown), the helical anchor 915 can be placed adjacent to the central pin 920. The ring 910 can be arranged such that when tension is applied to the ring 910, the ring 910 holds the helical anchor 915 and the central pin 920 locked in place. Figure 9AIn this arrangement, the cutout 905 receives the proximal portion of the helical anchor 915. The retaining ring 910 is in a stretched state, propelling the entire structure into the transspacer sheath.

[0147] Once in the desired position within the body, the anchoring conduit 900 is adjusted so that its distal end is positioned above the engagement hole 520. The central pin 920 and the helical anchor 915 are advanced such that the central pin 920 first pierces the tissue after passing through the engagement hole 520. Torque is applied to the anchoring conduit 900, causing the helical anchor 915 to pierce the tissue. The helical anchor 915 anchors the support structure 505 or the frame of the engagement aid 500 to the tissue. After the helical anchor 915 is in place, the central pin 920 is withdrawn. The withdrawal of the central pin 920 allows the ring 910 to slide over the crossbar 917 of the helical anchor 915, thereby releasing the anchor 915. This process can be repeated at other engagement sites to anchor the protrusions at both ends of the engagement aid 500.

[0148] Alternative anchoring technologies

[0149] Figure 10A An alternative anchoring technique is shown in another embodiment. In this embodiment, the delivery catheter 1000 may have multiple lumens 1040. The delivery catheter 1000 may have, for example... Figure 10B The cross-section shown is illustrated. The inner cavity 1040 can carry a single, distinct torsion-operated drive shaft. Each drive shaft can be locked to an anchor (in the case of shafts 1020 and 1030) or to a valve ring pivot 510 (as shown for shaft 1010). Each torsion-operated shaft 1010, 1020, 1030 can have… Figure 9A The design of the anchoring catheter 900 is illustrated in the figure. The delivery catheter 1000 may have a central lumen 1050 through which a guide wire or maneuverable catheter 600 may pass. Multiple torsion drive shafts 1010, 1020, 1030, the guide wire or maneuverable catheter 600, and the occlusion aid 500 can all be loaded into and withdrawn from the implant sheath of the delivery catheter 1000 before entering the transseptal sheath. In this way, the entire arrangement can be advanced and the occlusion aid 500 can be placed following the same procedure explained herein. An advantage of this arrangement is that the anchoring process can be completed without requiring multiple withdrawals of the anchoring catheter, reloading of the anchor, and re-entry into the body.

[0150] Alternative designs for anchors

[0151] Although some anchors have been described in this article, other alternative implementations are expected. Figure 11A An anchor with claw hooks is shown. Figure 11BAn umbrella-like anchor is shown. In both embodiments, the anchor can be made of a shape memory material. In both embodiments, the anchor can be loaded into a delivery conduit (such as...). Figure 11C (The delivery catheter shown in the diagram).

[0152] Locking mechanisms (such as those described herein) can be used to lock anchors to the delivery catheter. The delivery catheter may have a tip that allows it to be guided into position and make initial punctures into the tissue. After the delivery catheter is positioned and initial puncture is completed, one or more anchors can be advanced and installed in place. This step is followed by unlocking and withdrawing the delivery catheter.

[0153] Figure 11D yes Figure 11B The illustration shows the appearance of the umbrella-shaped anchor after it has been installed into the tissue to anchor the mating aid 500. Due to the natural stress-free shape of the anchor, when it unfolds in the tissue on the mating aid 500, the deformed shape will have an effective spring force on the surface of the mating aid 500, ensuring a good foothold.

[0154] Invertebral implants

[0155] exist Figure 5A The occlusion assist device 500 described in -F may include a support structure 505. The support structure 506 may be made of a shape memory material as described herein. In some embodiments of the occlusion assist device, another configuration is anticipated. This configuration may be referred to as a spineless occlusion assist device to indicate the removal of the support structure after placement of the occlusion assist device in the heart. Both types of occlusion assist devices can have certain advantages. A spineless occlusion assist device may be advantageous due to fewer components and materials and the absence of metal fatigue.

[0156] Figure 12 An embodiment of a choroidal occlusion assist device 1200 is shown. The choroidal occlusion assist device 1200 may include a tube or passageway 1210. Passageway 1210 may be positioned around the edge of the valve annulus. This passageway 1210 may be referred to as a valve annulus canal. The choroidal occlusion assist device 1200 may include a tube or passageway 1212 along a ventricular protrusion. This passageway 1212 may be referred to as a ventricular canal.

[0157] A cross-section of passage 1210 can be shown facing the end of the valve annulus. Although a circular cross-section is illustrated, the tube or passage 1210, 1212 may have other cross-sections, including but not limited to oval and flat ones.

[0158] Support structures 1210.1, 1210.2, and 1210.3 are shown by dashed lines, except at the annular margin where they protrude. Support structures 1210.1, 1210.2, and 1210.3 may have three distinct segments, with 1210.1 and 1210.3 positioned within the annular canal and 1210.2 within the ventricular canal. Support structures 1210.1, 1210.2, and 1210.3 may be coupled within the spinal center 1220. In some embodiments, support structures 1210.1, 1210.2, and 1210.3 may be different and separate segments. In some embodiments, support structures 1210.1, 1210.2, and 1210.3 may be joined together using one of a variety of methods, such as, but not limited to, crimping and laser welding. This arrangement of support structures 1210.1, 1210.2, 1210.3 and engagement auxiliary device 1200 allows support structures 1210.1, 1210.2, 1210.3 to be withdrawn from engagement auxiliary device 1200. In some methods, support structures 1210.1, 1210.2, 1210.3 are withdrawn by applying a tensile force to the ridge center 1220. Further details regarding engagement auxiliary device 1200 and the procedures for delivering and anchoring engagement auxiliary device 1200 will be provided herein.

[0159] Delivery procedures for invertebral implants

[0160] Figure 13A and 13B The diagram illustrates the delivery procedure of the coupling auxiliary device 1200. Figure 13A show Figure 12 The matching auxiliary device 1200. Figure 13A The additional component, anchoring part 1300, is shown. This anchoring part 1300 will be described in more detail in this document.

[0161] A maneuverable catheter 600 can be inserted into an occlusion assist device 1200. The maneuverable catheter 600 can be inserted from the distal tip of a ventricular protrusion 1212. The maneuverable catheter 600 can exit from an outlet port 1335. A delivery catheter 1320 can be provided. The delivery catheter 1320 may include a torsion shaft 1310. The delivery catheter 1320 may include a central locking component 1330 coupled to a central anchor 1300. Figure 13A In the diagram, the central locking component 1330 is shown as a screw. Other locking mechanisms explained herein may also be used.

[0162] Figure 13BFurther details regarding the delivery catheter 1320 are illustrated. The distal tip of the delivery catheter 1320 may include a funnel 1360. Proximal to the funnel 1360, an implant introducer 1340 may be present. At the proximal end, the delivery catheter 1320 may have a handle 1370.

[0163] A controllable conduit 600 can pass through an engagement aid 1200 as described herein. A funnel 1360 can be inserted into the distal tip of a delivery conduit 1320. The engagement aid 1200 can be locked in place using a locking member 1330, such that the central anchor 1300 is connected to the torsion shaft 1310.

[0164] The maneuverable catheter 600 can pass through the angled side port 1350 on the implant introducer 1340. The occlusion aid 1200 and the maneuverable catheter 600 can be pulled through the funnel 1360 by withdrawing the delivery catheter 1320. With continued withdrawal, the occlusion aid 1200 folds itself inside the implant introducer 1340. Once the implant is in the introducer 1340, the funnel 1360 is removed and discarded. The funnel 1360 can be designed to allow for easy removal. The design of the funnel includes, but is not limited to, a tear-off design (shown previously). Figures 8A-8C (in Chinese) or clam shell design ( Figure 13B ).

[0165] The delivery catheter 1320, together with the implant introducer 1340, can be advanced on the controllable catheter 600 until the implant introducer 1340 is centrally coupled to the transseptal sheath 650. At this point, the implant introducer 1340 may not be able to be advanced further, while the occlusion aid 1200 itself can be advanced into the transseptal sheath. The following steps are similar. Figures 8E to 8G The difference between those shown is that, in this embodiment, no implant sheath is used. The occlusion assist device 1200 is positioned above the posterior leaflet, and the ventricular protrusion 1212 is positioned in the left ventricle. The maneuverable catheter 600 can be withdrawn, allowing the ventricular protrusion 1212 to coil or coil below P2. Once the ventricular protrusion 1212 is anchored, the central anchor 1300 can be rotated or otherwise actuated. The central anchor 1300 can anchor the proximal side of the occlusion assist device 1200 to the valve annulus. The torsion shaft 1310 can be withdrawn. After additional anchoring (explained herein), the central locking component 1330 is withdrawn, pulling the support structures 1210.1, 1210.2, and 1210.3 along with it. The occlusion assist device 1200 can now operate in the left ventricle without the support structures 1210.1, 1210.2, and 1210.3.

[0166] Anchoring procedures for invertebral implants

[0167] Figure 14A This illustration shows an embodiment for anchoring the mating aid 1200. Since rigid structures such as support structures 1210.1, 1210.2, and 1210.3 may not be present after implantation, the mating aid 1200 may require additional anchors. In some embodiments, the mating aid 1200 may utilize closely spaced anchors. In some embodiments, the mating aid 1200 may utilize additional closely spaced anchors beyond those found in similar mating aids with support structures 505 described herein. Figure 14A An embodiment of the anchor 1400 is shown, which can be used to couple the mating aid 1200 and the tissue. Figure 14B Another implementation scheme is shown. Figure 14B In this embodiment, sutures or bands 1410 are used to "suture" the occlusion aid 1200 to the tissue. The sutures or bands 1410 can be made of one of several materials, including but not limited to polypropylene or nylon. Several embodiments of how multiple anchors are placed are now explained herein.

[0168] Figure 15A An embodiment of an anchor conduit 1500 for delivering multiple anchors is shown. Several anchors 1510 (including anchor 1510.1 and anchor 1510.2) are stacked within the anchor conduit 1500. Although Figure 15A Two anchors 1510.1 and 1510.2 are shown stacked within the anchor conduit 1500, but more or fewer anchors may be stacked. Each anchor 1510 may include a coiled section 1550. The coiled section 1550 may include a tip 1570. Anchor 1510 may include an anchor head 1560. The anchor head 1560 may have a shape composed of… Figure 15A One of the several cross sections shown in 1545.1, 1545.2, 1545.3, and 1545.4. Other cross sections are possible.

[0169] For initial loading of the anchoring conduit 1500, an anchor 1510 is loaded onto the central axis 1520 of the anchoring conduit 1500. The central axis 1520 and the anchor 1510 may have matching cross-sections such that the anchor 1510 is rotatably coupled to the central axis 1520. At the proximal end of the anchoring conduit 1500, a spring 1540 may be included. This spring 1540 provides thrust to rotate the central axis 1520, disengaging the anchor 1510 from the distal end of the anchoring conduit 1500 in the direction of arrow 1550. As the anchor 1510 disengages, it may engage the occlusion aid 1200 and tissue, thereby coupling the occlusion aid 1200 to the tissue. The rotation of the central axis 1520 may be controlled by an operator such as a physician. In some embodiments, the central axis 1520 is coupled to a torque-applying wire (not shown), which may be coupled proximally to a shank (not shown). In some embodiments, the torque-applying wire can be manually controlled. In some embodiments, the torque-applying wire can be controlled via an electric motor. The method used to apply rotational motion to the central shaft 1520 is intended. Figure 15A Features not shown include the ability to manipulate and position the distal end of the anchoring conduit 1500. When delivering an anchor 1510, the distal tip may need to be repositioned to deliver the next anchor 1510. Manipulation mechanisms such as pull wires may be included to manipulate the distal tip of the anchoring conduit 1500.

[0170] Figure 15B Another embodiment of the anchoring conduit 1600 for delivering multiple anchors is shown. Figure 15B Only the distal tip of the anchoring conduit 1600 is shown. The anchoring conduit 1600 may include multiple anchors 1610, such as 1610.1 and 1610.2. Although five anchors are shown for the anchoring conduit 1600, more or fewer anchors 1610 may be loaded at any one time. The anchoring conduit 1600 may have a central shaft 1630. The anchoring conduit 1600 may include threads, such as 1620 on the inside of the housing 1605. As shown, these threads 1620 can accommodate the coils of the anchors 1610. For initial loading of the anchoring conduit 1600, the anchors 1610 are inserted into the housing 1605. The anchors 1610 are inserted into the central shaft 1630. As previously stated, the cross-section of the central shaft 1630 can match the cross-section of the anchors 1610 so that the anchors 1610 can be mounted onto the central shaft 1630. Rotation of the central shaft 1630 can be controlled by a torque-applying cable (not shown) that couples the central shaft 1630 to the handle (not shown) of the anchoring conduit 1600. An operator, such as a physician, can control the rotation. In some embodiments, the torque-applying wire can be manually controlled.

[0171] In some embodiments, the torque-applying wire can be controlled via an electric motor. As the central shaft 1630 rotates, the threads force the anchor 1610 away from the anchoring conduit 1600 and engage the occlusion aid 1200 and the tissue, thus coupling the occlusion aid 1200 and the tissue together. The anchoring conduit 1600 may also have a pull wire for manipulating the distal tip of the anchoring conduit 1600, allowing the anchoring conduit 1600 to be positioned for the delivery of the next anchor 1610 as one anchor 1610 is delivered.

[0172] Figure 15B The illustration shows a central suture 1635. The central suture 1635 may include a ball 1640, which is coupled to an end of the central suture 1635. Figure 15C and 15D The illustration shows how the central suture 1635 and ball 1640 can be used. The ball 1640 can be placed in a slot within the first anchor 1610.1. The central suture 1635 can connect the first anchor 1610.1 to the second anchor 1610.2 and other anchors 1610 (not shown in the figure). This arrangement provides the ability to use the central suture 1635 as a guide wire to retract the anchor 1610 after it has been screwed into the tissue 1645. The operator may wish to retract the anchor 1610 to reposition or adjust it. Additionally, if one or more anchors 1610 become loose, the central suture 1635 can provide a tether for the loosened anchor 1610, thus preventing embolism.

[0173] Figure 16A -C illustrates another embodiment of an anchoring conduit 1700 for delivering multiple anchors. The anchoring conduit 1700 may have a hollow shaft. The hollow shaft may taper at a distal end, which can be used to pierce the apposition aid 1200 and tissue. Multiple anchors 1710, such as 1710.1, 1710.2, may be arranged within the hollow shaft of the anchoring conduit 1700. The anchors 1710 may be hollow barrels.

[0174] The suture 1720 can pass through the anchor 1710 as shown. The suture 1720 can be secured to the first anchor 1710.1 by arranging it to exit the second anchor 1710.2 and enter the first anchor 1710.1 through the side hole 1740. The suture 1720 can then be secured within the first anchor 1710.1 by means of a knot (as shown in the dashed line). The sutures 1720 in the other anchors 1710 besides the first anchor 1710.1 can appear as shown for anchor 1710.2. A portion of the wall of the anchors 1710 besides the first anchor 1710.1 is removed to form a cut. This cut assists in better embedding the anchor within the tissue, similar to a wall bolt. At the proximal end of the anchoring conduit 1700, a component such as a push rod tube 1750 may be present to allow anchors 1710, such as 1710.1 and 1710.2, to exit the anchoring conduit 1700 distally. The push rod 1750 may be attached to a handle (not shown) to enable an operator, such as a physician, to place one or more anchors 1710 as appropriate. Arrow 1760 indicates the direction of push.

[0175] Figure 16B -C is illustrated. Figure 16A How can the 1700 anchoring conduit be operated? Figure 16B In the middle, the anchoring conduit 1700 is through, for example, by... Figure 5A The groove propulsion described in section 520 passes through the engagement auxiliary device 1200. Then, the anchoring conduit 1700 pierces the tissue 1645. The operator pushes the first anchor 1710.1 out of the anchoring conduit 1700, placing the anchor 1710.1 within the tissue. Once the first anchor 1710.1 is placed, as... Figure 16C The remaining portion of the anchor 1710 is shown in the diagram. Figure 16C After the first anchor 1710.1 is placed, the anchoring conduit 1700 is pulled out of the tissue to enter the second position. In the second position, the anchoring conduit 1700 can place the second anchor 1710.2. This process continues until the occlusion aid 1200 needs to be secured to the tissue. After the last anchor 1710 is delivered, a cutter (not shown) can advance within the anchoring conduit 1700 to cut the suture 1720, leaving the anchor 1710 intact.

[0176] In some embodiments, the anchors 1710 may be radiopaque or they may be covered by radiopaque markings. During the delivery of the anchors 1710, the radiopaque markings may be visible using a fluorescent microscope. This can help to separate the anchors 1710 around the valve rings of the engagement aid 1200.

[0177] In some implementations, the MR is evaluated while the fixation assist device 1200 is fixed, and the pitch and / or position of the suturing action are determined based on the presence or absence of the MR.

[0178] Invertebral implants with cannulas

[0179] Figure 17A Another embodiment of the invertebral occlusion assist device 1800 is illustrated. In this embodiment, the support structure 1810 can move downwards only along the ventricular protrusion 1820. A tube or passage 1830 can exist around the annular edge of the occlusion assist device 1800. Instead of using the support structure 1810 to maintain the shape of the occlusion assist device 1800, an anchoring catheter 1850 can be inserted into the tube 1830, such as... Figure 17B As shown. In Figure 17B In this context, the anchoring conduit 1850 can be a deflectable anchoring conduit.

[0180] Figure 17B It also shows the first part 1860.1, where delivery such as by Figure 15A The anchor described in section 1560. At this location 1860.1 and all anchoring locations 1860, the tip of the anchoring conduit 1850 is deflected by an externally located control. The anchor (not shown) can be delivered to secure the occlusion aid 1800 to the tissue. The tip of the anchoring conduit 1850 may be radiopaque, and thus can be visualized during the anchor delivery process. The visualization of the tip can be used to position the anchor around the valve annulus of the occlusion aid 1800. Figure 17B The diagram shows the first anchorage position, 1860.1. Figure 17C The diagram illustrates the second anchoring position 1860.2. After delivering the appropriate number of anchors, the anchoring guide 1850 is completely withdrawn, as shown. Figure 17D As shown in the diagram. Finally, the support structure 1810 can be removed, as shown in the diagram. Figure 17E As shown in the image.

[0181] exist Figures 17A-17E In a variation of the illustrated embodiment, the support structure 1810 may not be limited to a ventricular protrusion; it may also be inserted via a cannula 1830 to maintain the desired shape. The support structure may be a shape memory material. An anchoring conduit can be created using the support structure surrounding the cannula 1830, which is used for… Figure 17A Compared to the anchoring conduit 1850 of the coupling auxiliary device 1800 described herein, it has a relatively simple control mechanism.

[0182] It is anticipated that multiple combinations or sub-combinations of the specific features and aspects of the disclosed embodiments can be made, and said combinations or sub-combinations still fall within one or more of the inventions herein. Furthermore, any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc., disclosed herein can be used together with the embodiments in all other embodiments given herein. Therefore, it should be understood that various features and aspects of the disclosed embodiments can be combined or substituted with each other to form different ways of the disclosed invention. Therefore, the scope of the invention intended to be disclosed herein should not be limited to the specific disclosed embodiments above. Furthermore, although the invention is open to various modifications and alternative forms, specific examples of which have been shown in the drawings and described in detail herein, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any methods disclosed herein need not be performed in the order stated. The methods disclosed herein include certain actions taken by a person skilled in the art; however, they may also explicitly or implicitly include any third-party instructions regarding those actions. For example, an action such as “inserting an assistive device near the mitral valve” includes “instructing the insertion of an assistive device near the mitral valve.” The scope disclosed herein also includes any or all overlaps, sub-scopes, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., includes the stated numbers. Numbers preceded by terms such as “approximately,” “about,” and “substantially” as used herein include the stated numbers and also indicate a quantity close to the stated quantity that still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” and “substantially” can refer to a quantity within a range of less than 10% of the stated quantity, less than 5% of the stated quantity, less than 1% of the stated quantity, less than 0.1% of the stated quantity, or less than 0.01% of the stated quantity.

Claims

1. An implantable closing assist system, comprising: Implant, the implant comprising: Shape memory structure; Biocompatible membrane coupled to the shape memory structure; and The valve annulus is placed proximally to the implant; and A delivery catheter, wherein the implant is configured to be placed within the patient’s heart with the delivery catheter positioned above the annulus center for anchoring the annulus center to the annulus, wherein the delivery catheter is configured to lock onto the annulus center to transport the implant to the heart.

2. The implantable occlusion assist system of claim 1, wherein the implant further comprises a ventricular protrusion, wherein the ventricular protrusion is coupled to an anchoring device.

3. The implantable apposition assist system of claim 1, wherein the implant comprises an active anchor.

4. The implantable mate assist system of claim 1, wherein the implant comprises a passive anchor.

5. The implantable occlusion assist system of claim 1, wherein the implant includes an active anchor configured to be driven through tissue to couple the implant to the valve annulus.

6. The implantable occlusion assist system of claim 1, wherein the implant further comprises a width of 20 mm to 60 mm.

7. The implantable occlusion assist system of claim 1, wherein the implant further comprises a width of 35 mm.

8. The implantable occlusion assist system of claim 1, wherein the implant further comprises a height of 10 mm to 40 mm.

9. The implantable occlusion assist system of claim 1, wherein the implant further comprises a height of 25 mm.

10. The implantable occlusion assist system of claim 1, wherein the implant further comprises a length of 5 mm to 35 mm.

11. The implantable occlusion assist system of claim 1, wherein the implant further comprises a length of 15 mm.

12. The implantable occlusion assist system of claim 1, further comprising one or more holes or perforations along the edge of the biocompatible membrane on the proximal side.

13. The implantable apposition assist system of claim 1, wherein the shape memory structure includes a shape memory ridge.

14. The implantable occlusion assist system of claim 13, wherein the shape memory ridge comprises nitinol or PEEK.

15. The implantable occlusion assist system of claim 13, wherein the shape memory ridge includes micropores.

16. The implantable occlusion assist system of claim 13, wherein the shape memory ridge comprises microhoops.

17. The implantable occlusion assist system of claim 1, wherein the implant is configured to be folded for delivery via a percutaneous catheter.

18. The implantable occlusion assist system of claim 1, wherein the implant further comprises a ventricular protrusion, wherein a portion of the ventricular protrusion is radiopaque.

19. The implantable occlusion assist system of claim 1 further includes a maneuverable catheter.

20. The implantable occlusion assist system of claim 19, wherein the controllable catheter includes a controllable shaft and a rotatable stem, the rotatable stem being coupled to a traction wire placed within the controllable shaft to adjust the bending radius of the distal tip of the controllable shaft according to the amount of torque applied to the rotatable stem.

21. The implantable occlusion assist system of claim 1, wherein the delivery catheter includes a rotatable shank coupled to a traction wire placed within a torsion shaft to adjust the radius of curvature of the distal tip of the torsion shaft of the delivery catheter.

22. The implantable occlusion assist system of claim 1, wherein the delivery catheter includes a sheath designed to receive the implant when the implant is folded.

23. The implantable occlusion assist system of claim 1, wherein the delivery catheter includes a distal tip, the distal tip further including a locking component capable of connecting the delivery catheter to the valve annulus of the implant or to an anchor.

24. The implantable occlusion assist system of claim 1, wherein the delivery catheter includes a ring that travels from a proximal stem to a distal tip such that tension in the ring is controlled via a control on the proximal stem.

25. The implantable occlusion assist system of claim 1, wherein the implant is operatively coupled to the tissue via a first coupling of the delivery catheter to an anchor and a second coupling of the anchor to the annular center, wherein a torque is applied to the delivery catheter to insert the anchor into the annular center and the tissue.

26. The implantable occlusion assist system of claim 25, wherein the first coupling is configured to be decoupled to retract the delivery catheter.

27. The implantable occlusion assist system of claim 1, further comprising a manipulable catheter, wherein the ability to deflect a distal portion of the manipulable catheter is advantageous for achieving a suitable position of the implant.

28. The implantable occlusion assist system of claim 1, wherein the delivery catheter is torsion-compatible and deflectable.

29. The implantable occlusion assist system of claim 1, wherein the implant is configured to be anchored in the atrial orientation of the mitral valve on the mitral annulus.

30. The implantable occlusion assist system of claim 1, wherein the shape memory structure includes a first segment extending between the upper and lower edges of the implant and a second segment extending between a first and a second lateral edge, wherein the first and second segments of the shape memory structure are integrally formed.

31. The implantable occlusion assist system of claim 1, wherein the shape memory structure includes a first region oriented parallel to the longitudinal axis of the implant and a second region oriented perpendicular to the longitudinal axis of the implant.

32. The implantable occlusion assist system of claim 1, wherein the valve annulus central is configured to receive a helical tissue anchor through its dimensions.

Images