Prosthetic septal device for heart valve

Abstract

The present application relates to a prosthetic septal device for a heart valve. An implantable prosthetic device includes a septal member configured to be disposed between leaflets of a native heart valve positioned between a first chamber and a second chamber of a heart. The prosthetic device further includes a plurality of anchoring members coupled to the septal member and configured to capture the leaflets between respective anchoring members and the septal member such that the prosthetic device is held between the leaflets. When the leaflets are captured between the anchoring members and the septal member, the septal member is configured to provide a flow path through the prosthetic device between the first chamber and the second chamber such that blood can flow retrograde through the septal member from the second chamber to the first chamber.

Description

[0001] This application is a divisional application of the original application with the filing date of September 7, 2018, the application number of 201880066104.9, and the invention title of "Prosthetic septal device for heart valve". TECHNICAL FIELD

[0002] The present application relates to devices and methods for treating heart valves, such as the mitral valve, for regurgitation. BACKGROUND

[0003] Natural heart valves (e.g., the aortic valve, the pulmonary valve, the tricuspid valve, and the mitral valve) play a critical role in ensuring forward flow of adequate blood supply through the cardiovascular system. These heart valves can become compromised due to congenital malformations, inflammatory processes, infectious conditions, or disease, and thus become less effective. This compromise to the valve can lead to serious cardiovascular impairment or death. For many years, the definitive treatment for such compromised valves has been surgical repair or valve replacement during open-heart surgery. However, open-heart surgery is highly invasive and is susceptible to many complications. Thus, high-risk patients, including the elderly and infirm with defective heart valves, are often left untreated. More recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery. One particular transvascular technique for accessing the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, up the inferior vena cava, and into the right atrium. The septum is then punctured and the catheter is threaded into the left atrium. Due to the high success rate of such transvascular techniques, they have become increasingly popular.

[0004] A healthy heart is generally conical tapering to a lower pointed end. The heart has four chambers and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy compared to the other natural heart valves. The mitral valve includes an annulus portion, which is an annular portion of native valve tissue around the mitral orifice, and a pair of leaflets or cusps that extend downward from the annulus to the left ventricle. The mitral annulus can form a "D" shape, an oval, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, and when they close together, a generally "C" shaped boundary is formed between the abutting free edges of the leaflets.

[0005] When functioning normally, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also known as "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle forces the two leaflets together, closing the one-way mitral valve so that blood cannot flow back into the left atrium, but is instead expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus into the left atrium, a number of fibrous cords called chordae tendinae tether the leaflets to papillary muscles in the left ventricle.

[0006] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart cycle when the heart contracts. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles, and / or left ventricular dilation causing stretching of the mitral annulus. Mitral regurgitation at the center of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation near one commissure of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation.

[0007] Some prior art for treating mitral regurgitation includes directly suturing portions of the native mitral valve leaflets to each other (known as an "Alfieri stitch"). Other prior art includes using a leaflet clip (such as the MitraClip® leaflet clip by Abbott Laboratories ), which is clipped onto the coaptation edges of the native mitral valve leaflets and holds them together to mimic an Alfieri stitch. Unfortunately, The devices have a number of drawbacks. For example, directly securing the leaflets to each other places undue stress on the leaflets, which can cause tearing and detachment of individual leaflets. Also, The devices have a relatively narrow profile and can only capture very small areas of the leaflets, which creates stress areas on the leaflets and can cause trauma to the leaflets. Directly fastening the leaflets to each other also prevents the captured portions of the coaptation edges from separating during ventricular diastole, which can inhibit antegrade blood flow through the mitral valve.

[0008] Also, implanting the devices can be difficult for a number of reasons. For example, the devices can be difficult to position and / or deploy in the heart, and the devices can be difficult to operate once implanted. The procedure for locating the device is relatively difficult and time-consuming. For example, it is difficult to correctly position the device so that the clamping member is behind the natural leaflet that moves during the cardiac cycle. Furthermore, positioning or retrieval... During device placement, the clamping components may become entangled or snagged on adjacent tissues (such as chordae tendineae). Removing the device from entangled tissue can be difficult and may cause tissue trauma. Another disadvantage is that because only a very small area of ​​the lobule is held together, a single [device / device]... Devices alone will often not be sufficient to reduce mitral regurgitation. Thus, multiple devices (e.g., two to four) are typically required to adequately address the regurgitation, which further increases the complexity and time required to complete the procedure.

[0009] Furthermore, it is difficult to manipulate within a small area of ​​the left atrium. The remote portion of the delivery system. For example, The delivery system does not allow for independent positioning of the implant in the anterior-posterior, vertical, and medial-lateral directions. Because... Limitations of the delivery system, such as adjustments to the delivery system in the medial-lateral direction, will alter the vertical positioning of the implant. Therefore, the use of... Positioning the implant along the junctional edge in the desired location using a delivery system is difficult and / or time-consuming.

[0010] Therefore, there is a continued need for improved devices and methods for treating mitral regurgitation. Summary of the Invention

[0011] Some embodiments of this disclosure relate to apparatus and methods for treating regurgitated heart valves. For example, in a representative embodiment, the implantable prosthetic device includes a spacer member configured to be disposed between leaflets of a natural heart valve located between a first and second chamber of the heart. The prosthetic device further includes a plurality of anchoring members coupled to the spacer member and configured to capture leaflets between the respective anchoring members and the spacer member, such that the prosthetic device is held between the leaflets. When the leaflets are captured between the anchoring members and the spacer member, the spacer member is configured to provide a flow path through the prosthetic device between the first and second chambers, allowing blood to flow back from the second chamber to the first chamber via the spacer member.

[0012] In some embodiments, the spacer member includes a porous body.

[0013] In some embodiments, the porous body includes a wire mesh.

[0014] In some embodiments, the first chamber is a left ventricle and the second chamber is a left atrium, and the spacer member is configured to allow a regurgitant blood flow through the device from the left ventricle to the left atrium that is 5% to 30% of a left ventricle stroke volume of the left ventricle at the time the device is implanted.

[0015] In some embodiments, the spacer member comprises a porous covering.

[0016] In some embodiments, the porous covering comprises a knit fabric.

[0017] In some embodiments, the porous covering comprises an openwork fabric.

[0018] In some embodiments, the first chamber is a left ventricle and the second chamber is a left atrium, and the porous covering is configured to promote tissue ingrowth such that a regurgitant blood flow through the device from the left ventricle to the left atrium decreases from 15% to 30% of a left ventricle stroke volume of the left ventricle at the time the device is implanted to 0% to 20% of a left ventricle stroke volume of the left ventricle over a period of one month to six months.

[0019] In some embodiments, the native heart valve is a mitral valve, and the porous covering is configured to promote tissue ingrowth such that a regurgitant blood flow through the device from the second chamber to the first chamber decreases from an amount corresponding to a contrast grading of mitral regurgitation having MR > 3+ to an amount corresponding to a contrast grading of mitral regurgitation having MR < 2+ over a period of one month to six months.

[0020] In some embodiments, the native heart valve is a mitral valve, the prosthetic device is coupled to a delivery device prior to implantation, and the prosthetic device is configured to allow a regurgitant blood flow through the spacer member after the prosthetic device is released from the delivery device. The regurgitant blood flow corresponds to a contrast grading of mitral regurgitation having MR > 2+.

[0021] In some embodiments, the prosthetic device is configured to allow a regurgitant blood flow through the spacer member, the regurgitant blood flow having an amount corresponding to a contrast grading of mitral regurgitation having MR > 3+.

[0022] In some embodiments, the prosthetic device is configured to allow a regurgitant blood flow through the spacer member, the regurgitant blood flow having an amount corresponding to a contrast grading of mitral regurgitation having MR > 4+.

[0023] In another representative embodiment, a method of implanting a prosthetic device includes advancing a prosthetic device in a compressed configuration to a native heart valve using a delivery device. The prosthetic device includes a spacer member and a plurality of anchor members, and the native heart valve is between a first chamber and a second chamber of a heart. The method further includes radially expanding the prosthetic device from the compressed configuration to an expanded configuration, and positioning the prosthetic device such that the spacer member is between leaflets of the native heart valve. The method further includes capturing the leaflets between the anchor members and the spacer member such that the prosthetic device is retained between the leaflets, and such that blood flows regurgitantly through the spacer member from the second chamber to the first chamber. The method further includes releasing the prosthetic device from the delivery device.

[0024] In some embodiments, the first chamber is a left atrium, the second chamber is a left ventricle, and the native heart valve is a mitral valve, and prior to implanting the prosthetic device, the left ventricle has a left ventricular ejection fraction that is less than 20% of a left ventricular end diastolic volume of the left ventricle.

[0025] In some embodiments, the first chamber is a left atrium, the second chamber is a left ventricle, and the native heart valve is a mitral valve, and after the prosthetic device is released, an amount of regurgitant blood flow through the spacer member is equivalent to a mitral regurgitation having an angiographic grading of MR > 2+.

[0026] In some embodiments, an amount of regurgitant blood flow through the spacer member is equivalent to a mitral regurgitation having an angiographic grading of MR > 3+.

[0027] In some embodiments, the first chamber is a left ventricle and the second chamber is a left atrium, and after capturing the leaflets, the spacer member is configured to allow a regurgitant blood flow through the device from the left ventricle to the left atrium that is 5% to 30% of a left ventricular stroke volume of the left ventricle.

[0028] In some embodiments, the spacer member includes a wire mesh.

[0029] In some embodiments, the spacer member includes a porous covering.

[0030] In some embodiments, the first chamber is a left ventricle and the second chamber is a left atrium, and the porous covering is configured to promote tissue ingrowth such that a regurgitant blood flow through the device from the left ventricle to the left atrium decreases from 15% to 30% of a left ventricular stroke volume of the left ventricle at the time of implantation of the device to 0% to 20% of a left ventricular stroke volume of the left ventricle over a period of one month to six months.

[0031] The foregoing and other objects, features and advantages of the disclosed technology will be more readily understood upon consideration of the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 An exemplary embodiment of a prosthetic septal device is illustrated, showing a first configuration.

[0033] Figure 2 A perspective view of a prosthetic septal device of Figure 1 is shown, showing a second configuration.

[0034] Figure 3 A perspective view of a prosthetic septal device of Figure 1 is shown, showing a third configuration.

[0035] Figure 4 A plan view of a clasp of a prosthetic septal device of Figure 1 is shown, showing a first configuration.

[0036] Figure 5 A perspective view of a clasp of a prosthetic septal device of Figure 1 is shown, showing a second configuration.

[0037] Figure 6 Another exemplary embodiment of a prosthetic septal device is illustrated.

[0038] Figure 7 A side view of a prosthetic septal device of Figure 6 is shown.

[0039] Figure 8A A side view of a wire mesh structure of a prosthetic septal device of Figure 6 is shown.

[0040] Figure 8B A side view of a prosthetic septal device of Figure 6 is shown, showing a covering over the wire mesh structure of Figure 8A .

[0041] Figure 9 Another exemplary embodiment of a prosthetic septal device is illustrated.

[0042] Figure 10 Another exemplary embodiment of a prosthetic septal device is illustrated.

[0043] Figure 11 An exemplary embodiment of a delivery assembly including a prosthetic septal device of Figure 6 (shown in partial cross-section) and a delivery device is illustrated.

[0044] Figure 12A A side view of a prosthetic septal device of Figure 11 is shown, coupled to a distal portion of a delivery assembly of Figure 6 , with the anchor and clasp in an open configuration.

[0045] Figure 12Bis a perspective view of a distal portion of a delivery assembly of Figure 11 , showing the prosthetic spacer device releasably coupled to the delivery device with the anchor and the catch in the closed configuration and without the covering.

[0046] Figure 13 is a perspective view of a distal portion of a delivery assembly of Figure 11 , showing the prosthetic spacer device released from the delivery device.

[0047] Figure 14 is a cross-sectional view of a coupling of a delivery device of Figure 11 .

[0048] Figure 15 is a perspective view of a delivery assembly of Figure 11 , showing the prosthetic spacer device in partial cross-section and showing some components of the delivery device schematically.

[0049] Figure 16 is a plan view of a shaft of a delivery device of Figure 11 .

[0050] Figure 17 is a side view of a proximal portion of a delivery device of Figure 11 .

[0051] Figure 18 is a cross-sectional view of a proximal portion of a delivery device of Figure 11 , taken along line 18-18 shown in Figure 17 .

[0052] Figure 19 is an exploded view of a proximal portion of a delivery device of Figure 11 .

[0053] Figures 20 to 24 illustrates an exemplary implantation procedure of a prosthetic spacer device of Figure 11 using a delivery assembly of Figure 6 to repair a native mitral valve (shown in part) of a heart.

[0054] Figure 25 illustrates a prosthetic spacer device of Figure 6 located between leaflets of a mitral valve before being released from a delivery assembly and allowing regurgitant blood flow through the device.

[0055] Figure 26 illustrates a prosthetic spacer device of Figure 25 after being released from a delivery assembly and allowing regurgitant blood flow through the device.

[0056] Figure 27Ais a perspective view illustrating the mitral valve and the base of the left atrium with a prosthetic spacer device deployed between the native leaflets and causing the leaflets to form a double orifice during ventricular diastole.

[0057] Figure 27B is a perspective view illustrating the mitral valve and the base of the left atrium with a prosthetic spacer device deployed between the native leaflets and causing the leaflets to form a double orifice during ventricular diastole. DETAILED DESCRIPTION

[0058] Described herein are embodiments of prosthetic spacer devices intended primarily to be implanted in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, as well as devices and methods for implanting the same. The prosthetic spacer devices can be used to help restore and / or replace the function of a defective native valve.

[0059] Existing prosthetic spacer devices are generally configured to reduce or prevent valve regurgitation immediately upon implantation in a heart valve, and particularly in the mitral valve. For example, in a typical configuration, a prosthetic spacer device can include a central or main body and one or more movable elements configured to capture the leaflets of a native valve between the elements and the main body. The native leaflets can thereby form a seal against the main body. The main body, in turn, can be configured to prevent blood flow through the prosthetic device, such that a sharp reduction in mitral regurgitation is achieved upon implantation. This can be advantageous in patients whose left heart function is not severely degraded. For example, where a patient’s left ventricular ejection fraction (LVEF) is greater than 20% of the left ventricular volume, an immediate reduction in mitral regurgitation upon implantation of the device can be acceptable. As used herein, “left ventricular ejection fraction” and the abbreviation “LVEF” refer to the fraction of left ventricular end-diastolic volume that is ejected from the left ventricle during ventricular contraction.

[0060] However, in patients with LVEF less than 20%, a dramatic reduction in mitral regurgitation at the time of implantation of a prosthetic septal device can cause significant stress on the left ventricle, potentially leading to heart failure. For example, according to the American Society of Echocardiography defined methods and guidelines, in patients with moderate to severe or severe mitral regurgitation graded as 3+ or 4+, a sudden reduction in mitral regurgitation from graded as MR > 3+ or MR > 4+ to graded as MR < 2+ can lead to heart failure and / or death. Accordingly, provided herein are embodiments of prosthetic septal devices that provide a significant acute mitral regurgitation through the device at the time of implantation. The devices can be configured to slowly reduce the mitral regurgitation over a period of, for example, days, weeks, or months. This can reduce the stress on the left ventricle associated with a sudden reduction in mitral regurgitation. As used herein, reference to, for example, “mitral regurgitation” or “MR” graded as 1+, 2+, 3+, or 4+ refers to the angiographic grading guidelines provided by the American Society of Echocardiography using assessment techniques including, for example, echocardiography, color Doppler, fluoroscopy, etc. (Zoghbi et al, ASE Guidelines and Standards: Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation - A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance, Journal of the American Society of Echocardiography, April 2017).

[0061] Embodiments of the prosthetic septum device described herein can include a septum member and at least one anchor. In certain embodiments, the prosthetic septum device can further include at least one clasp and at least one collar. The septum member can be configured to be positioned within a native valve orifice to fill the space between malfunctioning native leaflets that cannot naturally fully coapt. In certain examples, the septum member can be configured to allow acute regurgitation through the prosthetic device when the device is implanted, and to gradually reduce regurgitation through the device (e.g., as the implant endothelializes). In such examples, the septum member can be configured to provide a flow path for retrograde blood flow (e.g., from the left ventricle to the left atrium during ventricular contraction) through the prosthetic device. Other examples of prosthetic septum devices are further described in U.S. Application No. 15 / 973,892, filed May 8, 2018. The septum member can have various shapes. In some embodiments, the septum member can have an elongated cylindrical shape having a circular cross-sectional shape. In other embodiments, the septum member can have an oval cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes.

[0062] In certain embodiments configured to be implanted in a native mitral valve, the septum member can have an atrial or upper end positioned in or near the left atrium of the heart, a ventricular or lower end positioned in or near the left ventricle of the heart, and an annular side extending between the native mitral valve leaflets.

[0063] The anchors can be configured to secure the prosthetic septum device to one or more native leaflets such that the septum member is positioned between the native leaflets. The anchors can be configured to be positioned behind the native leaflets when implanted such that the native leaflets are captured between the anchors and the septum member.

[0064] Figures 1 to 5 An exemplary embodiment of a prosthetic septum device 100 and its components is shown. With reference to Figure 1 , the prosthetic septum device 100 can include a septum member 102, a plurality of anchors or paddles 104 (e.g., two of two in the illustrated embodiment), a plurality of clasps 106 (e.g., two in the illustrated embodiment), a first collar 108, and a second collar 110. As best shown in Figure 3 , a first end 112 of the anchors 104 can be coupled to and extend from a first end 114 of the septum member 102, and a second end 116 of the anchors 104 can be coupled to the first collar 108. The second collar 110 can be coupled to a second end 118 of the septum member 102.

[0065] The spacer member 102 and the anchor portion 104 can be coupled together in various ways. For example, as shown in the example embodiment, the spacer member 102 and the anchor portion 104 can be coupled together by integrally forming the spacer member 102 and the anchor portion 104 into a single unified component. For example, see the following reference... Figure 8A In more detail, this can be accomplished by forming the spacer member 102 and the anchor portion 104 from a braided or woven material (such as braided or woven nitinol wire). Therefore, although in practice the spacer member and the anchor portion could be made of braided and / or woven wire, for illustrative purposes these features are... Figures 1 to 3 The spacer member 102 and the anchoring portion 104 may be coupled together by welding, fasteners, adhesives and / or other means of coupling.

[0066] refer to Figure 2 The anchoring portion 104 may include a first portion 120 and a second portion 122 separated by a joint portion 124. In this way, the anchoring portion 104 is configured to resemble a leg, since the first portion 120 resembles the upper part of the leg, the second portion 122 resembles the lower part of the leg, and the joint portion 124 resembles the knee portion of the leg.

[0067] The anchoring portion 104 can be configured to move between various configurations by axially moving the first collar 108 relative to the spacer member 102 along a longitudinal axis extending between the first end 114 and the second end 118 of the spacer member 104, and thus moving the anchoring portion 104. For example, by moving the first collar 108 away from the spacer member 102, the anchoring portion 104 is tightened, and the anchoring portion 104 can be positioned in a vertical configuration. In the vertical configuration, the connecting portion 124 of the anchoring portion 106 is adjacent to the longitudinal axis of the spacer member 102 (e.g., similar to...). Figure 20 (The configuration shown in the figure).

[0068] From the straight configuration, the anchoring portion 104 can be moved to a fully folded configuration by moving the first collar 108 toward the spacer member 102 (e.g., ...). Figure 1 Initially, as Figures 2 to 3 As shown, as the first ring 108 moves toward the spacer member 102, the anchoring portion 104 bends at the connecting portion 124, and the connecting portion 124 moves radially outward relative to the longitudinal axis of the spacer member 102 and axially toward the first end 114 of the spacer member 102. Figure 1As the first collar 108 continues to move toward the spacer member 102, the connecting portion 124 moves radially inward relative to the longitudinal axis of the spacer member 102 and axially toward the second end 118 of the spacer member 102, as shown in FIG. 1C.

[0069] In some embodiments, when the anchor portion 104 is in the straightened configuration (see, e.g., FIG. 1A), the angle between the first portion 120 of the anchor portion 104 and the spacer member 102 can be approximately 180 degrees, while when the anchor portion 104 is in the fully folded configuration, the angle between the first portion 120 of the anchor portion 104 and the spacer member 102 can be approximately 0 degrees. The anchor portion 104 can be positioned in various partially folded configurations such that the angle between the first portion 120 of the anchor portion 104 and the spacer member 102 can be approximately 10-170 degrees or approximately 45-135 degrees. Figure 20

[0070] Configuring the prosthetic spacer device 100 such that the anchor portion 104 can extend to a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the spacer member 102) can provide a number of advantages. For example, this can reduce the radial crimp profile of the prosthetic spacer device 100. It can also make it easier to capture the native leaflets by providing a larger opening in which to capture the native leaflets. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the prosthetic spacer device 100 will become entangled in native anatomical structures (e.g., chordae tendinae) when positioning and / or retrieving the prosthetic spacer device 100 into a delivery device.

[0071] Referring again to Figure 2 , the clasp 106 can include an attachment portion 126 and an arm portion 128. The attachment portion 126 can be coupled to the first portion 120 of the anchor portion 104 in various ways, such as with sutures, adhesives, fasteners (e.g., a plate 129), welds, and / or means for coupling.

[0072] The arm portion 128 can pivot relative to the attachment portion 126 between an open configuration (e.g., FIG. 1A) and a closed configuration (FIG. 1B). Figure 2 Figure 1 In some embodiments, the clasp 106 can be biased to the closed configuration. In the open configuration, the attachment portion 126 and the arm portion 128 are pivoted away from each other such that a native leaflet can be positioned between the attachment portion 126 and the arm portion 128. In the closed configuration, the attachment portion 126 and the arm portion 128 are pivoted toward each other, thereby clamping the native leaflet between the attachment portion 126 and the arm portion 128. 3 Referring to

[0073] , the attachment portion 126 ( Figures 4 to 5 Figures 4 to 5 ​​​The attachment portion 126 (only one of which is shown) can include one or more openings 130 (e.g., three in the illustrated embodiment). At least some of the openings 130 can be used to couple the attachment portion 126 to the anchor portion 104. For example, sutures and / or fasteners can extend through the openings 130 to couple the attachment portion 126 to the anchor portion 104.

[0074] The arm portion 128 can include a plurality of side beams 132 that are spaced apart to form a slot 134. The slot 134 can be configured to receive the attachment portion 126. The arm portion 128 can also include a fixed end portion 136 coupled to the attachment portion 126 and a free end portion 138 disposed opposite the fixed end portion 138.

[0075] The free end portion 138 can include a clamping element, such as a barb 140 and / or other means for frictionally engaging native leaflet tissue. The clamping element can be configured to engage and / or penetrate the native leaflet tissue to help retain the native leaflet between the attachment portion 126 and the arm portion 128 of the clasp 106.

[0076] The free end portion 138 can also include an eyelet 142 that can be used to couple the free end portion 138 to an actuation mechanism configured to pivot the arm portion 128 relative to the attachment portion 126. Additional details regarding coupling the clasp 106 to an actuation mechanism are provided below.

[0077] In some embodiments, the clasp 106 can be formed from a shape memory material, such as Nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, the clasp 106 can be formed by laser cutting a flat sheet of material (e.g., Nitinol) and then setting the shape of the clasp 106 in the configuration shown in Figure 4 Figure 5 In the configuration shown in

[0078] Setting the clasp 106 in this manner can provide a number of advantages. For example, the clasp 106 can be compressed from the set configuration (e.g., Figure 5 ) to a flat configuration (e.g., Figure 4 ), which reduces the radially crimped profile of the clasp 106. Moreover, this also improves the trackability and retrievability of the prosthetic annuloplasty device 100 relative to the catheter shaft of a delivery device, as the barbs 140 point radially inward toward the anchor portion 104 (see, e.g., Figure 20 ) as the prosthetic annuloplasty device 100 is advanced through or retrieved into the catheter shaft. Thus, this prevents or reduces the likelihood of the clasp 106 catching or shaving the catheter shaft.

[0079] Additionally, when the clasp 106 is in the closed configuration, the barbs 140 are positioned to engage the native leaflet tissue in a manner that is less likely to cause trauma to the native leaflet tissue than when the clasp 106 is in the set configuration. For example, the barbs 140 can be positioned to engage the native leaflet tissue in a manner that is less likely to cause trauma to the native leaflet tissue than when the clasp 106 is in the set configuration. Figure 5 ​The configuration in which the fastener 106 is set can increase the clamping force of the fastener 106. This is because the arm 128 is set to a first position relative to the attachment portion 126 (e.g., Figure 5 ), which is beyond the position that the arm 128 can reach when the fastener 106 is attached to the anchor 104 (e.g., Figure 3 ), because the anchor 104 prevents the arm 128 from moving further toward the set configuration. When the fastener 106 is attached to the anchor 104 and in the closed configuration, this results in the arm 128 having a preload (i.e., a clamping force greater than zero). Thus, the fastener 106 can have an increased clamping force in the Figure 5 configuration compared to the fastener set in the closed configuration.

[0080] The magnitude of the preload of the fastener 106 can be changed by adjusting the angle at which the arm 128 is set relative to the attachment portion 126. For example, increasing the relative angle between the arm 128 and the attachment portion 126 increases the preload, and decreasing the relative angle between the arm 128 and the attachment portion 126 decreases the preload.

[0081] In some embodiments, the second collar 110 and / or the spacer member 102 can include a hemostatic seal 144 configured to reduce or prevent the flow of blood through the second collar 110 and / or the spacer member 102. For example, as shown in Figure 1 some embodiments, the hemostatic seal 144 can include a plurality of flexible flaps 146. The flaps 146 can be configured to pivot from a sealed configuration to an open configuration to allow a delivery device to extend through the second collar 110. The flaps 146 can be configured to return from the open configuration to the sealed configuration when the delivery device is removed. In other embodiments, the device need not include such a seal.

[0082] Figures 6 to 8B An exemplary embodiment of a prosthetic spacer device 200 is shown. The prosthetic spacer device 200 can include a spacer member 202, a plurality of anchors 204, a plurality of fasteners 206, a first collar 208, and a second collar 210. These components of the prosthetic spacer device 200 can be configured substantially similarly to the corresponding components of the prosthetic spacer device 100.

[0083] The prosthetic spacer assembly 200 may also include a plurality of anchoring extension members 212. The anchoring extension members 212 may be configured as loops having a first end 214 coupled to and extending from a first loop 208 and a second end 216 arranged opposite to the first end 214. The anchoring extension members 212 may be configured to extend circumferentially beyond the anchoring portion 204 around the spacer member 202. For example, in some embodiments, each of the anchoring extension members 216 may extend around approximately half the circumference of the spacer member 202 (e.g., Figure 7 As best shown in the middle), and the anchoring portion 204 can extend around the circumference of less than half of the spacer member 202 (as shown in the middle). Figure 6 (As best shown in the middle). The anchoring extension member 216 may also be configured to extend laterally (i.e., perpendicular to the longitudinal axis of the spacer member 202) beyond the outer diameter of the spacer member 202.

[0084] The anchoring extension member 212 may be further configured such that when the prosthetic spacer device 200 is in a folded configuration (e.g., Figure 6 At step 8), the free end 216 of the anchoring extension member 212 is axially adjacent to the connecting portion 218 of the anchoring portion 204 and is radially arranged between the first portion 220 and the second portion 222 of the anchoring portion 206.

[0085] The configuration of the anchor extension member 212 in this manner provides an increased surface area compared to the standalone anchor 204. For example, this makes it easier to capture and secure the natural leaflet. The increased surface area also distributes the clamping force of the anchor 204 and the anchor extension member 212 against the natural leaflet over a relatively large surface area of ​​the natural leaflet, thereby further protecting the natural leaflet tissue.

[0086] The increased surface area of ​​the anchoring extension member 212 also allows the natural leaflet to be clamped to the prosthetic spacer device 200, such that the natural leaflet engages with the prosthetic spacer device 200 at a position adjacent to it, rather than against the spacer member 202. This, for example, can improve the seal of the natural leaflet and help to ultimately reduce mitral regurgitation.

[0087] As described above, the components of the prosthetic spacer device described herein (such as spacer members and / or anchoring members) can be made of porous structures (such as woven and / or braided mesh). Figure 8A A representative implementation of this web structure 240 is illustrated, comprising a plurality of filaments or strands 242. Figure 8AIn some embodiments, the filaments 242 can be braided together to form the oval shape of the spacer member 202 such that the mesh structure defines a plurality of openings 244 around substantially the entire surface of the spacer member. The spacer member 202 can also define respective top and bottom central openings 246, 248 that are directed into the interior of the spacer member. The filaments 242 can be braided together to form the anchor 204.

[0088] Figure 8B An assembled device 200 is illustrated that includes a covering 250 disposed about the spacer member 202 and the anchor 204. In some examples, the covering 250 can be porous such that the covering is permeable to blood flow. For example, in the illustrated embodiment, the covering 250 can be a mesh or web that defines a plurality of openings, generally indicated at 252. In certain examples, the covering 250 can include a low density knitted polyester fabric having, for example, 60-120 courses per inch and 20-60 wales per inch. The covering 250 can also include any of a variety of woven fabrics (e.g., velour), non-woven fabrics (e.g., fleece or gauze), or any of a variety of porous or blood permeable polymeric materials (e.g., expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), etc.).

[0089] In certain examples, the covering 250 can be permeable to blood such that blood can flow through the covering 250, through the mesh structure 240, and into or out of the interior of the spacer member 202. In this manner, the spacer member 202 can provide a flow path through the prosthetic spacer device, generally indicated by the double-headed arrow 254. The direction of blood flow along the flow path 254 can be, for example, from an area of higher blood pressure to an area of lower blood pressure, such as from the left ventricle to the left atrium during ventricular systole. In certain examples, blood can also flow through the openings 246, 248. As described in more detail below, this can provide acute regurgitant blood flow through the prosthetic spacer device and, in particular, through the spacer member 202 when the device is implanted.

[0090] Figure 9 and 10 Other embodiments of prosthetic spacer devices that can be used in conjunction with the above-described porous covering embodiments are illustrated. Figure 9An exemplary embodiment of a prosthetic septal device 300 is shown, which includes an annular septal member 302 in the form of a metal frame and anchors 304 extending from the septal member 302. The ends of each anchor 304 can be coupled to a respective strut of the septal member 302 by a respective sleeve 306, which can be crimped around the end of the anchor 306 and the strut of the septal member 302. One or more barbs or protrusions 308 can be mounted on the frame of the septal member 302. The free ends of the protrusions 308 can include various shapes, including rounded, pointed, barbed, etc. The protrusions 308 can exert a retaining force against the native leaflets by virtue of the anchors 304, which are shaped to push the native leaflets inward into the septal member 302 in the area below the free ends of the anchors 304. As noted above, the device 300 can include a porous covering to allow blood flow through the septal member 302.

[0091] Figure 10 Another embodiment of a prosthetic septal device 400 is shown. The prosthetic septal device 400 can include an annular septal member 402 in the form of a metal frame and anchors 404 extending from the septal member 402, similar to the prosthetic septal device 300. The anchors 404 of the prosthetic septal device 400 can be configured similar to the anchors 304 of the prosthetic septal device 300, except that the bend at the free end of each anchor 404 includes a larger radius than the anchors 304. In this way, the anchors 404 cover a relatively larger portion of the septal member 402 than the anchors 304. This can distribute the clamping force of the anchors 404 against the native leaflets over a relatively larger surface of the native leaflets, for example, to further protect the native leaflet tissue. This can also improve the seal, as the native leaflets are clamped against the prosthetic septal device 400 such that the native leaflets are joined together at the location adjacent to the prosthetic septal device 400, rather than against the septal member 402.

[0092] Likewise, one or more barbs or protrusions 406 can be mounted on the frame of the septal member 402. The free ends of the protrusions 406 can include stops 408 configured to limit the extent to which the protrusions 406 can engage and / or penetrate the native leaflets. As noted above, the device 400 can also include a porous covering to allow blood flow through the septal member 402.

[0093] Further details regarding prosthetic septal devices can be found in U.S. Patent Application Publication No. 2016 / 0331523, for example.

[0094] The prosthetic septal device devices described herein can be coupled to a delivery device to form a delivery assembly. The delivery device can be used to percutaneously deliver, position, and / or secure the prosthetic septal device device within a native heart valve region of a patient. Figures 11 to 27B An example delivery assembly 500 and components thereof are shown. Referring to Figure 11 , the delivery assembly 500 can include the prosthetic septal device device 200 and a delivery device 502. The delivery device 502 can include a plurality of catheters and a catheter stabilizer. For example, in the example embodiment, the delivery device 502 includes a first catheter 504, a second catheter 506, a third catheter 508, and a catheter stabilizer 510. The second catheter 506 coaxially extends through the first catheter 504, and the third catheter 508 coaxially extends through the first and second catheters 504, 506. As described further below, the prosthetic septal device device 200 can be releasably coupled to a distal end portion of the third catheter 508 of the delivery device 502.

[0095] In the example embodiment, the delivery assembly 500 is configured, for example, for implanting the prosthetic septal device device 200 into a native mitral valve via a transseptal delivery approach. In other embodiments, the delivery assembly 500 can be configured for implanting the prosthetic septal device device 200 into the aortic, tricuspid, or pulmonary valve region of a human heart. Also, the delivery assembly 500 can be configured for various delivery approaches, including transseptal, transaortic, transventricular, etc.

[0096] Figure 12A and Figure 12B A prosthetic septal device device 200 coupled to a distal end of a delivery device is illustrated. In Figure 12A , the septal device device 200 is shown in an open configuration and includes a covering 250. In Figure 12B and 13 , the septal device device 200 is shown without the covering 250, with the septal member 202 and the anchor member 204 shown schematically as solid members for example purposes. Referring to Figure 13 , a first or distal collar 208 of the prosthetic septal device device 200 can include a bore 226. In some embodiments, as best shown in Figure 12B , the bore 226 can include internal threads configured to releasably engage corresponding external threads of an actuation shaft 512 of the delivery device 502.

[0097] Referring again to Figure 13 , a second or proximal collar 210 of the prosthetic septal device device 200 can include a central opening 228 that is axially aligned with the bore 226 of the distal collar 208. As Figure 12BAs best shown, the central opening 228 of the proximal collar 210 can be configured to slidably receive the actuation shaft 512 of the delivery device 502. In some embodiments, the proximal collar 210 and / or the spacer member 202 can have a sealing member (not shown, but see, e.g., the sealing member 144 shown in Figure 1 the sealing member 144 shown in

[0098] As Figure 13 As best shown, the proximal collar 210 can also include a plurality of bosses or projections 230 and a plurality of guide openings 232. The bosses 230 can extend radially outwardly and can be circumferentially offset (e.g., 90 degrees) relative to the guide openings 232. The guide openings 232 can be disposed radially outwardly from the central opening 228. As shown in FIG. 12, the projections 230 and guide openings 232 of the proximal collar 210 can be configured to releasably engage the couplings 514 of the delivery device 502.

[0099] Referring again to Figure 11 And as mentioned above, the delivery device 502 can include a first catheter 504 and a second catheter 506. The first catheter 504 and the second catheter 506 can be used, for example, to access an implantation site (e.g., the native mitral valve region of a heart) and / or to position the third catheter 508 at the implantation site.

[0100] The first catheter 504 and the second catheter 506 can include first and second sheaths 516, 518, respectively. The catheters 504, 506 can be configured such that the sheaths 516, 518 are steerable. Additional details regarding the first catheter 504 can be found, for example, in U.S. Patent Application Publication No. 2016 / 0155987. Additional details regarding the second catheter 506 can be found, for example, in U.S. Publication No. 2018 / 0126124.

[0101] Still referring to Figure 11 As mentioned above, the delivery device 502 can also include a third catheter 508. The third catheter 508 can be used, for example, to deliver, steer, position, and / or deploy the prosthetic spacer device 200 at the implantation site.

[0102] Referring to Figure 15The third catheter 508 can include an actuation shaft or inner shaft 512, a coupling 514, an outer shaft 520, a handle 522 (shown schematically), and a fastener control member 524. A proximal end portion 520a of the outer shaft 520 can be coupled to the handle 522 and extend distally therefrom, and a distal end portion 520b of the outer shaft 520 can be coupled to the coupling 514. A proximal end portion 512a of the actuation shaft 512 can be coupled to an actuation knob 526. The actuation shaft 512 can extend distally from the knob 526 (shown schematically), through the handle 522, through the outer shaft 520, and through the coupling 514. The actuation shaft 512 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 520 and the handle 522. The fastener control member 524 can extend through the handle 522 and the outer shaft 520 and be axially movable relative thereto. The fastener control member 524 can also be axially movable relative to the actuation shaft 512. In some embodiments, the fastener control member 524 can be configured as a suture, and can be looped through the opening 234 in the fastener 206. In other embodiments, the fastener control member 524 can include a sleeve 1102 through which the connecting member and release member extend, as shown in Figure 12A U.S. Application No. 15 / 973,892, filed above.

[0103] As shown best in Figure 12A , Figure 12B and Figure 13 , the actuation shaft 512 of the third catheter 508 is releasably coupled to the distal collar 208 of the prosthetic septal device 200. For example, in some embodiments, a distal end portion 512b of the actuation shaft 512 can include external threads configured to releasably engage internal threads of the bore 226 of the prosthetic septal device 200. As such, rotating the actuation shaft 512 in a first direction (e.g., clockwise) relative to the distal collar 208 of the prosthetic septal device 200 releasably secures the actuation shaft 512 to the distal collar 208. Rotating the actuation shaft 512 in a second direction (e.g., counterclockwise) relative to the distal collar 208 of the prosthetic septal device 200 releases the actuation shaft 512 from the distal collar 208.

[0104] Referring now to Figures 12A to 14 , the coupling 514 of the third catheter 508 can be releasably coupled to the proximal collar 210 of the prosthetic septal device 200. For example, in some embodiments, the coupling 514 can include a plurality of flexible arms 528 and a plurality of stabilizer members 530. The flexible arms 528 can include apertures 532, ports 533 Figure 13 , and eyelets 534 Figure 14 .

[0105] The flexible arms 528 can be configured to pivot between a first or release configuration Figure 13 and a second or coupled configuration Figure 12B and 14 In the first configuration, the flexible arms 528 extend radially outward relative to the stabilizer member 530. As best shown in Figure 14 the second configuration, the flexible arms 530 extend axially parallel to the stabilizer member 530, and the eyelets 534 radially overlap. The flexible arms 528 can be configured (e.g., shaped) so as to be biased to the first configuration.

[0106] The prosthetic spacer device 200 can be releasably coupled to the coupler 514 by inserting the stabilizer member 530 of the coupler 514 into the guide opening 232 of the prosthetic spacer device 200. The flexible arms 528 of the coupler 514 can then be pivoted radially inward from the first configuration to the second configuration such that the protrusion 230 of the prosthetic spacer device 200 extends radially into the holes 532 of the flexible arms 528. The flexible arms 528 can be held in the second configuration by inserting the distal end portion 512b of the drive shaft 512 through the openings 536 of the eyelets 534, which prevents the flexible arms 528 from pivoting radially outward from the second configuration to the first configuration, thereby releasably coupling the prosthetic spacer device 200 to the coupler 514.

[0107] The prosthetic spacer device 200 can be released from the coupler 514 by proximally retracting the actuation shaft 512 relative to the coupler 514 such that the distal end portion 512b of the actuation shaft 512 is withdrawn from the openings 536 of the eyelets 534. This allows the flexible arms 528 to pivot radially outward from the second configuration to the first configuration, which withdraws the protrusion 230 of the prosthetic spacer device 200 from the holes 532 of the flexible arms 528. The stabilizer member 530 can remain inserted into the guide opening 232 of the prosthetic spacer device 200 during and after the flexible arms 528 are released. This can prevent the prosthetic spacer device 200 from moving (e.g., shifting and / or wobbling) when the flexible arms 528 are released, for example. The stabilizer member 530 can then be withdrawn from the guide opening 232 of the prosthetic spacer device 200 by proximally retracting the coupler 514 relative to the prosthetic spacer device 200, thereby releasing the prosthetic spacer device 200 from the coupler 514.

[0108] Referring to Figure 15 the outer shaft 520 of the third catheter 508 can be an elongated shaft that extends axially between a proximal end portion 520a of the coupling handle 522 and a distal end portion 520b that is coupled to the coupler 514. The outer shaft 520 can also include an intermediate portion 520c that is disposed between the proximal end portion 520a and the distal end portion 520b.

[0109] Referring to Figure 16The outer shaft 520 may include a plurality of axially extending cavities, including an actuation shaft cavity 538 and a plurality of control member cavities 540 (e.g., four in the example embodiment). In some embodiments, the outer shaft 520 may include more (e.g., six) or fewer (e.g., two) control member cavities 540 than four.

[0110] Actuation shaft cavity 538 may be configured to receive actuation shaft 512, and control member cavity 540 may be configured to receive one or more fastener control members 524. Cavities 538 and 540 may also be configured such that the actuation shaft 512 and the fastener control member 524 are movable relative to their respective cavities 538 and 540 (e.g., axially and / or rotatably). In certain embodiments, cavities 538 and 540 may include linings or coatings configured to reduce friction within the cavities 538 and 540. For example, cavities 538 and 540 may include PTFE-containing linings.

[0111] Still referencing Figures 15 to 16 The outer shaft 520 can be formed of a variety of materials, including metals and polymers. For example, in one particular embodiment, the proximal portion 520a may comprise stainless steel, and the distal portion 520b and the intermediate portion 520c may comprise PEBA (e.g., ...). The outer shaft 520 may also include an external covering or coating, such as a reflowed polymer on portions 520a, 520b and 520c.

[0112] The outer shaft 520 may include one or more coil portions 542 arranged radially outward from the inner cavities 538, 540. For example, in one particular embodiment, the outer shaft 520 may include a first coil 542a, a second coil 542b, and a third coil 542c. The first coil 542a may be the radially outermost coil, the third coil 542c may be the radially innermost coil, and the second coil 542b may be arranged radially between the first coil 542a and the third coil 542c.

[0113] The coil portion 542 may include various materials and / or configurations. For example, the coil portion 542 may be formed of stainless steel. In one particular embodiment, the first coil 542a and the third coil 542c comprise stainless steel coils wound in a left-handed configuration, and the second coil 542b comprises a stainless steel coil wound in a right-handed configuration.

[0114] The coil portions 542 can also include various pitches. The pitch of one or more of the coils 542 can be the same or different than the pitch of one or more other coils 542. In one particular embodiment, the first coil 542a and the second coil 542b can have a first pitch (e.g., 0.74 inches), while the third coil can include a second pitch (e.g., 0.14 inches).

[0115] The outer shaft 520 can also include a tether layer 544 disposed radially inward from the third coil 542c. The tether layer 544 can be formed from various materials including a polymer (e.g., PEBA (e.g., )) and / or other materials.

[0116] As shown in Figures 17 to 19 , the handle 522 of the third catheter 508 can include a housing 546, an actuation lock mechanism 548, a fastener control mechanism 550, and an irrigation mechanism 552. Referring to Figure 17 , a distal end portion of the housing 546 can be coupled to a proximal end portion 520a of the outer shaft 520. The actuation lock mechanism 548, the fastener control mechanism 550, and the irrigation mechanism 552 can be coupled to a proximal end of the housing 546. The actuation lock mechanism 548 can be configured to selectively lock the position of the actuation shaft 512 relative to the housing 546 and the outer shaft 520. The fastener control mechanism 550 can also be coupled to a proximal end portion of the fastener control member 524 and can be configured to secure the fastener control member 524 relative to the handle 522 and to move the fastener control member 524 relative to the outer shaft 520 and the actuation shaft 512. The irrigation mechanism 552 can be configured to irrigate the outer shaft 520 (e.g., with a saline solution) prior to insertion of the outer shaft 520 into the vasculature of a patient.

[0117] As shown most clearly in Figures 18 to 19 , the housing 546 of the handle 522 can include a main body 554 and a nose portion 556 coupled to a distal end portion of the main body 554. The main body 554 and the nose portion 556 can be coupled together in various ways, including fasteners 558 and / or pins 560 (e.g., as shown in the illustrated embodiment), adhesives, and / or other coupling means. The housing 546 can be formed from various materials, including polymers (e.g., polycarbonate).

[0118] The main body 554 of the housing 546 can include a plurality of lumens, including an actuation shaft lumen 562, a control member lumen 564 Figure 19 , and an irrigation lumen 566 Figure 18 fluidly connected to the actuation shaft lumen 562. As shown in Figure 19As best shown, the body 554 can also include a plurality of tubes (e.g., hypotube) including an actuation tube 568 and a control member tube 570 disposed at least partially within the actuation shaft lumen 562 and the control member lumen 564, respectively. The tubes 568, 570 can be axially movable (e.g., slidable) relative to the lumens 562, 564, respectively.

[0119] A proximal end of the actuation tube 568 can extend proximally from the body 554 and can be coupled to the knob 526 and the proximal portion 512a of the actuation shaft 512. A proximal end of the control member tube 570 can extend proximally from the body 554 and can be coupled to the catch control mechanism 550 and the catch control member 524.

[0120] The distal ends of the tubes 568, 570 can include flanges 572, 574 configured to engage with stops to limit axial movement of the tubes 568, 570 relative to the housing 546. For example, the flanges 572, 574 can be configured to contact respective surfaces (e.g., lips) of the body 554 to prevent the tubes 568, 570 from being fully withdrawn from the proximal ends of the lumens 562, 564, respectively.

[0121] The actuation tube 568 can be configured to receive and be coupled to the proximal portion of the actuation shaft 512. As further described below, the control member tube 570 can be configured to receive portions of the catch control mechanism 550. The tubes 568, 570 can be formed from a variety of materials including polymers and metals (e.g., stainless steel).

[0122] In some embodiments, the body 554 can include a plurality of sealing members 576 (e.g., O-rings) configured to prevent or reduce leakage of blood through the lumens and around the shafts and / or tubes. The sealing members can be secured relative to the body 554, for example, by fasteners 578 (e.g., hollow lock or socket-jam set screws).

[0123] As Figure 19As best shown, the nose 556 of the housing 546 can include a plurality of lumens, including an actuation shaft lumen 580 and a control member lumen 582. The actuation shaft lumen 580 of the nose 556 can extend coaxially with the actuation shaft lumen 562 of the main body 554. The proximal ends of the control member lumens 582 of the nose 556 can be aligned with the control member lumens 564 of the main body 554 at the proximal end of the nose 556 (i.e., the lumens 582, 564 are in the same plane). The control member lumens 582 can extend at an angle from their proximal ends (i.e., relative to the control member lumens 564 of the main body 554) toward one another, and the distal ends of the control member lumens 582 can intersect the actuation shaft lumen 580 at a location proximate the distal end of the nose 556. In other words, the proximal ends of the lumens 582 are in a first plane (i.e., the plane of the control member lumens 564 of the main body 554) that is parallel to the longitudinal axis of the catheter, and the distal ends of the lumens 582 are in a second plane (i.e., the plane of the actuation shaft lumen 562 of the main body 554) that is parallel to the longitudinal axis of the catheter.

[0124] As Figure 18 As best shown, the actuation shaft lumen 580 of the nose 556 can be configured to receive the proximal end portion of the outer shaft 520. The proximal end portion of the outer shaft 520 can be coupled to the nose 556 in various ways (e.g., with adhesive, fasteners, friction fit, and / or other coupling means).

[0125] Still referring to Figure 18 , the actuation lock mechanism 548 of the handle 522 can be coupled to the proximal end portion of the main body 554 of the housing 546 and to the actuation tube 568. The actuation lock mechanism 548 can be configured to selectively control relative movement between the actuation tube 568 and the housing 546. In turn, this selectively controls relative movement between the actuation shaft 512 (which is coupled to the actuation tube 568) and the outer shaft 520 (which is coupled to the nose 556 of the housing 546).

[0126] In some embodiments, the actuation lock mechanism 548 can include a locked configuration that prevents relative movement between the actuation tube 568 and the housing 546, and a released configuration that allows relative movement between the actuation tube 568 and the housing 546. In some embodiments, the actuation lock mechanism 548 can be configured to include one or more intermediate configurations (i.e., in addition to the locked and released configurations) that allow relative movement between the actuation tube 568 and the housing 546, but that cause a greater force to be required for the relative movement than when the actuation lock mechanism is in the released configuration.

[0127] As an example embodiment of Figure 18As shown in FIG. 6, the actuation locking mechanism 548 can include a lock (e.g., a Tuohy-Borst adapter) 584 and a coupler (e.g., a female luer coupler) 586. The coupler 586 can be attached to a distal end of the lock 584 and coupled to a proximal end of the main body 554 of the housing 546. The actuation tube 568 can extend coaxially through the lock 584 and the coupler 586. As such, rotating the knob 588 of the lock 584 in a first direction (e.g., clockwise) can increase the frictional engagement of the lock 584 on the actuation tube 568, thus making relative movement between the actuation tube 568 and the housing 546 more difficult or preventing it altogether. Rotating the knob 588 of the lock 584 in a second direction (e.g., counterclockwise) can decrease the frictional engagement of the lock 584 on the actuation tube 568, thus making relative movement between the actuation tube 568 and the housing 546 easier.

[0128] In other embodiments, the actuation locking mechanism 548 can include other configurations configured to prevent relative movement between the actuation tube 568 and the housing 546. For example, the actuation locking mechanism 548 can include a lock configured like a stopcock valve, where a plunger portion of the valve selectively engages the actuation tube 568.

[0129] In some embodiments, the actuation locking mechanism 548 can include a release member (e.g., a set screw or pin). The release member can extend into the housing 546 and can selectively engage the actuation tube 568. When the release member is engaged with the actuation tube 568 (e.g., by inserting the release member into the housing 546 and into contact with the actuation tube 568), the release member can, for example, prevent the actuation tube 568 and thus the actuation shaft 512 from being fully withdrawn from their respective lumens 568, 580 (e.g., when actuating the anchor 204). When the release member is released from the actuation tube 568 (e.g., by withdrawing it from the housing 546 and / or moving it out of contact with the actuation tube 546), the actuation tube 568 and thus the actuation shaft 512 can be fully withdrawn from their respective lumens 568, 580 (e.g., when releasing the prosthetic spacer device 200 from the delivery device 502).

[0130] The clasp control mechanism 550 can include an actuator member 590 and one or more locking members 592 (e.g., two in the example embodiment). As shown in FIG. 6, the actuator member 590 can be coupled to the control member tube 570, which extends from a proximal end of the main body 554 of the housing 546. The locking members 592 can be coupled to a proximal end of the actuator member 590. Figure 18 As best shown in FIG. 6, a distal portion of the actuator member 590 can be coupled to the control member tube 570, which extends from a proximal end of the main body 554 of the housing 546. The locking members 592 can be coupled to a proximal portion of the actuator member 590.

[0131] As shown in the example embodiment, the actuator member 590 can optionally include a first side 594 and a second side 596 selectively coupled to the first side 594 by a connecting pin 598. The actuator member 590 can be configured such that the first side 594 and the second side 596 move together when the connecting pin 598 is inserted through the first side 594 and the second side 596. When the connecting pin 598 is withdrawn, the first side 594 and the second side 596 can move relative to one another. This can allow the fastener control member 524 (which is releasably coupled to the first side 594 and the second side 596 by the locking member 592) to be individually actuated.

[0132] The connection between the first side 594 and the second side 596 can be configured such that the first side 594 and the second side 596 can move axially (i.e., proximally and distally) relative to one another, but not rotationally, when the connecting pin 598 is withdrawn. This can be accomplished, for example, by configuring the first side 594 with a key slot or groove and configuring the second side 594 with a key protrusion or tongue that corresponds to the key slot or groove of the first side 594. This can prevent or reduce the likelihood of the fastener control member 524 twisting relative to the outer shaft 520, for example.

[0133] The first side 594 and the second side 596 can include an axially extending internal lumen 501. The distal end of the internal lumen 501 can be configured to receive a proximal end portion of the control member tube 570. The proximal end of the internal lumen 501 can be configured to receive a portion of the locking member 592. As described above, the proximal end portion of the fastener control member 524 extends through the respective locking member 592.

[0134] The locking member 592 can be configured to selectively control the relative movement between the fastener control member 524 and the respective first side 594 or second side 596 of the actuator member 590. The locking member 592 can include a locked configuration that prevents relative movement between the fastener control member 524 and the respective first side 594 or second side 596 and a released configuration that allows relative movement between the fastener control member 524 and the respective first side 594 and second side 594. In some embodiments, the locking member 592 can also include one or more intermediate configurations (i.e., in addition to the locked and released configurations) that allow relative movement between the fastener control member 524 and the respective first side 594 or second side 596, but that require a greater force to effect the relative movement than when the locking member 592 is in the released configuration.

[0135] As shown in the example embodiment, the locking members 592 can be configured similar to a stopcock valve. Thus, rotating the knob 503 in a first direction (e.g., clockwise) can increase the frictional engagement between the locking members 592 on the clasp control members 524 and make relative movement between the clasp control members 524 and the respective first or second side portions 594, 596 more difficult or completely prevent it. Rotating the knob 503 in a second direction (e.g., counterclockwise) can decrease the frictional engagement between the locking members 592 on the clasp control members 524 and make relative movement between the clasp control members 524 and the respective first or second side portions 594, 596 easier. In other embodiments, the locking members 592 can include other configurations configured for preventing relative movement between the locking members 592 on the clasp control members 524.

[0136] The flush mechanism 552 can include a flush tube 505 and a valve 507 (e.g., a stopcock valve). A distal end of the flush tube 505 can be coupled to and in fluid communication with the flush lumen 566, and thus the actuation shaft lumen 562 of the main body 554. A proximal end of the flush tube 505 can be coupled to the valve 507. In this way, the flush mechanism 552 can be configured for flushing the outer shaft 520 (e.g., with a saline solution) prior to insertion of the outer shaft 520 into the vasculature of a patient.

[0137] As described further below, the clasp control members 524 can be configured to manipulate the configuration of the clasp 206. As shown best in FIG. 6, each clasp control member 524 can be configured as a suture (e.g., a wire or string) loop. A proximal end portion of the clasp control member 524 can extend proximally from a proximal end portion of the clasp control mechanism 550 and can be releasably coupled to the locking members 592 of the clasp control mechanism 550. Figure 15

[0138] The clasp control members 524 can form a loop from the locking members 592 that extends distally through the lumen 501 of the clasp control mechanism 550, through the control member tube 570, the control member lumens 564, 582 of the handle 522, and through the control member lumen 540 of the outer shaft 520. The clasp control members 524 can extend radially outward from the lumen 540, e.g., through the port 533 of the coupling 514 Figure 13 ). The clasp control members 524 can then extend through the opening 234 of the clasp 206 (e.g., similar to the opening 142 of the prosthetic annuloplasty device 100). The clasp control members 524 can then extend proximally back through the coupling 514, radially inward through the port 533 of the coupling 514, and then proximally through the outer shaft 520 and the handle 522, and to the locking members 592 of the clasp control mechanism 550. ​

[0139] In Figure 15 In the example embodiment shown in FIG. 27, the fastener control member 524 is shown to be slack and the fastener 206 is shown to be partially open so as to illustrate the fastener control member 524 extending through the opening 234 of the fastener 206. However, generally when the fastener control member 524 is slack, the fastener 206 will be in the closed configuration.

[0140] As shown in the example embodiment, each fastener control member 524 can extend through a plurality of control member lumens 540 of the outer shaft 520. For example, each fastener control member 524 can loop through two control member lumens 540. In other embodiments, each fastener control member 524 can be disposed in a single control member lumen 540. In other embodiments, a plurality of fastener control members 524 can be disposed in a single control member lumen 540.

[0141] With the fastener control member 524 coupled to the fastener 206, the fastener control mechanism 550 can be used to actuate the fastener 206 between the open and closed configurations. The fastener 206 can be opened by moving the actuator member 590 proximally relative to the knob 526 and the housing 546. This increases the tension on the fastener control member 524 and moves the fastener 206 from the closed configuration to the open configuration. The fastener 206 can be closed by moving the actuator member 590 distally relative to the knob 526 and the housing 546. This decreases the tension on the fastener control member 524 and allows the fastener 206 to move from the open configuration to the closed configuration. The fastener 206 can be individually actuated by removing the connecting pin 598 and moving the first side 594 or the second side 596 relative to one another, the knob 526, and the housing 546.

[0142] As best shown in Figures 17 to 18 When the handle 522 is assembled, the actuation shaft 512 can extend distally from the knob 526, through the actuation tube 568, through the actuation lumens 562, 580 of the housing 546, through the actuation shaft lumens 538 of the outer shaft 520, and through the coupling 514, as best shown in

[0143] Figures 20 to 2 7 shows the delivery assembly 500 being used to implant the prosthetic spacer device 200 in the native mitral valve 600 of the heart 602, for example, using a transseptal delivery approach. Although not shown, a guide wire can be inserted into the patient's vasculature (e.g., the femoral vein) through a introducer sheath. The guide wire can be advanced through the femoral vein, through the inferior vena cava, into the right atrium, through the atrial septum (e.g., via the fossa ovalis), and into the left atrium 606. As best shown in Figure 20 The first sheath 516 of the first catheter 504 can be advanced over the guide wire such that a distal end portion of the first sheath 516 is disposed in the left atrium 606, as best shown in

[0144] The prosthesis spacer device 200 is coupled to the third catheter 508 (e.g., as shown in the image). Figure 12A and 12B As shown in the diagram, and configured in a radially compressed delivery configuration, the prosthesis spacer device 200 can be loaded into the second sheath 518 of the second catheter 506, the second sheath 518 holding the prosthesis spacer device 200 in the delivery configuration. In this way, the distal portion of the second sheath 518 serves as a delivery capsule for the prosthesis implant 200. In some embodiments, the radially compressed delivery configuration can be an axially elongated configuration (e.g., similar to...). Figure 20 (The configuration shown). In other embodiments, the radially compressed delivery configuration can be an axially shortened configuration (e.g., similar to...). Figure 22 (As shown in the configuration). Then, the second catheter 506, along with the prosthetic spacer device 200 and the third catheter 508, can be advanced together through the first catheter 504 until the distal portion of the sheath 518 extends outward from the distal portion of the first sheath 516 and is positioned in the left atrium 606, as shown. Figure 20 As shown.

[0145] like Figure 20 As shown, the prosthetic spacer device 200 can be exposed from the second sheath 518 by advancing the outer shaft 520 and actuation shaft 512 of the third conduit 508 distally relative to the second sheath 518 and / or retracting the second sheath 518 relative to the outer shaft 520 and actuation shaft 512, thus forcing the anchoring portion 204 away from the second sheath 518. Once exposed from the second sheath 518, the anchoring portion 204 can be folded by retracting the actuation shaft 512 of the third conduit 508 relative to the outer shaft 520 and / or by advancing the outer shaft 520 relative to the actuation shaft 512, causing the anchoring portion 204 to disengage from the second sheath 518. Figure 20 The radially compressed configuration shown bends to Figure 21 The part shown is folded, and then bent to Figure 22 The fully folded configuration is shown. This can be accomplished, for example, by placing the actuation locking mechanism 548 in a release configuration (e.g., by rotating the knob 588 counterclockwise relative to the handle 522), and then moving the knob 526 proximally relative to the housing 546. At any point in this procedure, the physician can lock the relative position of the actuation shaft 512 and the outer shaft 520 by actuating the actuation locking mechanism 548, and thus lock the position of the anchor 204.

[0146] Then, as Figure 22As shown, the prosthetic spacer device 200 can be coaxially positioned relative to the natural mitral valve 600 by manipulating (e.g., manipulating and / or bending) the second sheath 518 of the second catheter 506. The prosthetic spacer device 200 can also be rotated relative to the natural mitral valve 600 (e.g., by rotating the housing 546) such that the anchoring portion 204 is aligned with the natural leaflet 608 of the mitral valve 600. The curvature of the second sheath 518 can be adjusted (e.g., by a manipulating mechanism) such that the distal manipulating segment 518a extends at an angle of approximately 90 degrees relative to the segment 518b extending proximally from the manipulating segment 518a. Advantageously, this positions the manipulating distal segment 518a and the prosthetic spacer device 200 along an axis substantially perpendicular to the plane defined by the natural mitral valve. In other words, the axis extending through the manipulating distal segment 518a and the prosthetic spacer device 200 is coaxial with or substantially parallel to the flow path of the natural mitral valve.

[0147] The retraction or advancement of the second sheath 518 of the second catheter 506 and the outer shaft 520 of the third catheter 508 relative to the first sheath 516 of the first catheter 504 and the left atrium 606 (e.g., in...) Figure 22 (in the direction indicated by arrow 521) the outer axis 520 of the third duct 508 and the prosthetic spacer device 200 are positioned relative to the natural leaflet 608 in the medial and lateral directions (e.g., in the direction indicated by arrow 521). Figure 27A (in the direction indicated by the middle arrow 523). As the second sheath 518 and outer shaft 520 are advanced and / or retracted, the prosthetic spacer assembly 200 moves relative to the natural mitral valve in the vertical / vertical direction (e.g., in the direction indicated by the middle arrow 523). Figure 22 The orientation (upward / downward) of the second catheter 506 remains at least substantially constant, and / or due to the configuration of the actuation mechanism of the second catheter 506 as described above, the second sheath 518 does not "whip". The second sheath 518 of the second catheter 506 rotates (this may also be referred to as "torquing") relative to the first sheath 516 of the first catheter 504 and the left atrium 606 (e.g., in...). Figure 22 In the direction indicated by the middle arrow 525), the outer shaft 520 of the third catheter 508 and the prosthesis spacer device 200 are aligned in the anterior / posterior direction (e.g., in the direction indicated by the middle arrow 525). Figure 27A Pivot in the direction indicated by the middle arrow 527. The prosthetic spacer device 200 can also be rotated relative to the natural mitral valve 600 (e.g., by rotating the housing 546) to align the anchoring portion 204 with the natural leaflet 608 of the natural mitral valve 600. The prosthetic spacer device 200 can be adjusted in the up / down direction relative to the natural mitral valve (e.g., in the direction indicated by the middle arrow 527). Figure 22Positioning (upward / downward) as shown in the diagram. Therefore, one advantage of the disclosed delivery device is that the positioning of the prosthetic spacer device can be independently adjusted in three directions (i.e., medial / lateral, anterior / posterior, and up / down). For example, actuating the delivery device such that movement of the prosthetic spacer device in the medial / lateral direction does not affect its positioning in the anterior / posterior or up / down directions. Thus, the three-dimensional and / or independent operability of the delivery device 502 allows practitioners to accurately and / or precisely position the prosthetic spacer device 200 at the desired implantation location relative to the natural lobule (e.g., at the A2 / P2 location near the center of the natural lobule's suture line) in a relatively quick and / or easy manner.

[0148] Then, by moving knob 526 distally relative to housing 546, the anchoring portion 204 of prosthetic spacer device 200 can be partially opened (i.e., moved radially outward relative to spacer member 202). Figure 23 The configuration is shown in the figure. The prosthetic spacer device 200 can then be advanced through the annulus of the natural mitral valve 600 and at least partially into the left ventricle 610. The prosthetic spacer device 200 is then partially retracted such that the anchoring portion 204 is positioned posterior to the ventricular portion of the leaflet 608 (e.g., at the A2 / P2 position), and the spacer member 202 is arranged on the atrial side of the leaflet 608. Alternatively, the prosthetic spacer device 200 can be in a fully folded configuration (e.g., as shown in the figure). Figure 22 (As shown) is pushed through the natural valve, after which the anchoring part 204 can be opened.

[0149] In this configuration, the natural leaflet 608 can be secured relative to the anchoring portion 204 by capturing it with fastener 206. The natural leaflet 608 can be captured simultaneously or separately by actuating actuator member 590. For example, Figure 24 Individual leaflet capture is shown. This can be accomplished by removing pin 598 from actuator component 590 and moving the first side 594 or the second side 596 relative to each other, the knob 526, and the housing 546. Moving the first side 594 or the second side 596 distally relative to the knob 526 and the housing 546 closes the fastener 206 on the natural leaflet 608 (e.g., as shown). Figure 24 (Example shown by the left fastener 206). Moving the first side 594 or the second side 596 proximally relative to the knob 526 and the housing 546 opens the fastener 206 (e.g., as shown). Figure 24 (Example shown by right fastener 206). When fastener 206 is closed, the physician can reopen fastener 206 to adjust its position.

[0150] As the catch 206 is reopened, the catch 206 initially moves radially inward toward the spacer member 202 (e.g., as shown in FIG. 6B), until the catch 206 contacts the spacer member 202 (e.g., as shown in FIG. 6C). In some cases, as the catch 206 is reopened, the barb 236 of the catch 206 can retain the native leaflet 608 and pull the native leaflet 608 toward the spacer member 202. Upon the catch 206 contacting the spacer member 202, further tensioning of the catch control member 524 moves the catch 206 slightly proximally relative to the spacer member 202 (and slightly expands the anchor 204). The proximal movement of the catch 206 can, for example, extract the barb 236 from the native leaflet 608, which can facilitate repositioning and / or retrieval of the prosthetic spacer device 200. Figure 24 Figure 23

[0151] Figure 25 As shown in FIG. 6D, with both native leaflets 608 secured within the catch 206, the physician can move the knob 526 proximally relative to the housing 546. This pulls the anchor 204, and thus the native leaflets 608, radially inward against the spacer member 202, as shown in FIG. 6E. The physician can then observe the positioning and / or regurgitant flow into the left atrium through the spacer device. Figure 25

[0152] Figure 25 For example, the prosthetic spacer device 200 is shown in a deployed configuration in the mitral valve 600 prior to release of the device from the delivery device. As the left ventricle 610 contracts, blood can flow regurgitantly along the flow path 254 through the spacer member 202 from the left ventricle 610 to the left atrium 606. In some embodiments, the leaflets 608 can form a seal against the spacer member 202 such that primary acute regurgitation is through the spacer member 202. If repositioning or removal is needed, the physician can reopen the anchor 204 and / or the catch 206.

[0153] ​​​​​Once the desired positioning and / or acute regurgitation is achieved, the physician can release the prosthetic septum device 200 from the delivery device 502. The clasp 206 can be released from the delivery device 502 by releasing the clasp control member 524 from the locking member 592 and disengaging the clasp control member 524 from the opening 234 of the clasp 206. The distal collar 208 of the prosthetic septum device 200 can be released from the delivery device 502 by rotating the knob 526 in the second direction relative to the housing 546 such that the actuation shaft 512 is withdrawn from the bore 226. The actuation shaft 512 can then be retracted proximally through the prosthetic septum device 200 by pulling the knob 526 proximally relative to the housing 524. The proximal collar 210 of the prosthetic septum device 200 can be released from the delivery device 502 by retracting the actuation shaft 512 proximally relative to the coupling 514 such that the distal end portion of the actuation shaft 512 is withdrawn from the eyelet 534 of the coupling 514. This allows the flexible arms 528 of the coupling 514 to move radially outward away from the protrusion 230 of the proximal collar 210. The stabilizer members 530 of the coupling 514 can then be withdrawn from the guide opening 232 of the proximal collar 210 by pulling the housing 546 proximally, thereby releasing the prosthetic septum device 200 from the delivery device 502 as shown in FIG. 6B. Figure 26

[0154] The shafts 512, 520 of the third catheter 308 can then be retracted proximally into the second sheath 518 of the second catheter 306, and the second sheath 518 of the second catheter 506 can be retracted proximally into the first sheath 516 of the first catheter 504. The catheters 504, 506, 508 can then be retracted proximally and removed from the patient’s vasculature.

[0155] As Figure 27A In some embodiments, as shown in FIG. 6B, in the case where the prosthetic septum device 200 is implanted in an A2 / P2 position, the native mitral valve 600 can include a double orifice during ventricular diastole. During ventricular systole, the native leaflets 608 can coapt together and / or against the prosthetic septum device 200 (e.g., to prevent or reduce mitral regurgitation through the leaflets). However, the prosthetic septum device 200 can provide for acute regurgitation or retrograde blood flow through the septum member 202 when the device is implanted. As used herein, the phrases “at implantation,” “at deployment,” and the like refer to the time when the native leaflets are captured between the anchor member and the septum member such that the prosthetic septum device is ready to be released from the delivery device, as well as minutes or hours (e.g., up to 12 hours) after the prosthetic septum device is released from the delivery device.

[0156] ​For example, in certain configurations, the amount of regurgitant blood flow through the septal member 202 when the prosthetic septal device is deployed can be equivalent to mitral regurgitation having an angiographic grading of at least MR > 2+, at least MR > 3, or at least MR > 4+. In other examples, the amount of regurgitant blood flow through the septal member 202 when the prosthetic septal device is deployed can be the same as or nearly the same as the amount of regurgitant blood flow through the native mitral valve prior to implantation of the device.

[0157] For example, a patient having moderate to severe mitral regurgitation (e.g., having an angiographic grading of MR > 3+) can have 30%, 40%, or more than 40% of the left ventricular stroke volume of the patient as regurgitant blood flow in each cardiac cycle prior to implantation of the prosthetic septal device. As used herein, the term “left ventricular stroke volume” refers to the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume. In adult humans, the left ventricular end-diastolic volume can be from 120 mL to 165 mL, 130 mL to 155 mL, or 140 mL to 150 mL. In certain examples, the average left ventricular end-diastolic volume in male and female subjects aged 20 to 79 can be 142 mL ± 21 mL. In humans, the left ventricular end-systolic volume can be from 30 mL to 60 mL, 35 mL to 55 mL, or 40 mL to 50 mL. In certain examples, the average left ventricular end-systolic volume in male and female subjects aged 20 to 79 can be 47 mL ± 10 mL. In adult human hearts, the left ventricular stroke volume can be from 60 mL to 135 mL, 70 mL to 120 mL, 80 mL to 110 mL, 81 mL to 109 mL, or 90 mL to 100 mL. In certain examples, the average left ventricular stroke volume in human hearts of male and female subjects aged 20 to 79 can be 95 mL ± 14 mL. In certain examples, MR > 3+ can be associated with a regurgitant blood flow from the left ventricle to the left atrium of greater than 30 mL, greater than 40 mL, greater than 50 mL, 30 mL to 80 mL, 40 mL to 70 mL, 45 mL to 65 mL, or 50 mL to 60 mL. In Edwards Lifesciences Corporation In testing of the device, a total of 23 participants, of which 5 participants exhibited MR grading of 3+ and 18 participants exhibited MR grading of 4+, with an average regurgitant flow of 58 mL (standard deviation of 30 mL) for all participants. (Praz et al.,“Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study,” Lancet vol. 390, pp. 773-780, 2017).

[0158] As used herein, the term“cardiac cycle” refers to a systolic and diastolic period together comprising one complete heartbeat. After implantation of the prosthetic septum device, the amount of regurgitant blood flow through the device 200 can also be moderate to severe (e.g., equivalent to a contrast grading of MR > 3+) at the time the device is deployed or shortly thereafter. For example, the amount of regurgitant blood flow through the septum member 202 during each cardiac cycle can be 5% to 30% of left ventricular stroke volume at least one hour, at least one day, at least one week, or at least one month after implantation. In certain examples, this can greatly reduce the pressure on the left ventricle associated with a sudden reduction in mitral regurgitation.

[0159] By further example, a patient with severe mitral regurgitation (e.g., a contrast grading of MR > 4+) can have a regurgitant blood flow of 40% or more of left ventricular stroke volume during each cardiac cycle prior to implantation of the prosthetic septum device. After implantation of the prosthetic septum device, the regurgitant blood flow through the device can also be severe (e.g., equivalent to a contrast grading of MR > 4+, or no less than MR > 3+) at the time the device is deployed or shortly thereafter. For example, the amount of regurgitant blood flow through the septum member 202 during each cardiac cycle can be equivalent to 15% to 30% of left ventricular stroke volume at least one hour, at least one day, at least one week, or at least one month after implantation. In other examples, the regurgitant blood flow through the device can be equivalent to MR > 2+. In still other examples, the regurgitant blood flow through the device can be significant enough to reduce or prevent acute impairment of left ventricular function, such as afterload mismatch.

[0160] In certain instances, the cover 250 can be configured to promote tissue ingrowth into the cover, also referred to herein as “endothelialization.” Endothelialization of the prosthetic septal device 200 can slowly reduce the amount of regurgitant blood flow through the septal member 202 and can improve long-term stability of the implant. For example, after implantation, endothelium in contact with various parts of the prosthetic septal member 200 can grow into the cover 250 such that the device is covered or encapsulated in endothelial tissue. Encapsulation of the prosthetic septal device 200 by endothelium can occur over a period of, for example, one to six months. In this manner, endothelial tissue can use the prosthetic septal device 200 as a scaffold to form an endothelial “tissue bridge” that extends between and couples the mitral valve leaflets to one another. Figure 27B An example of the leaflets 608 coupled together by the prosthetic septal device 200 in the A2 / P2 region after the device has been encapsulated by endothelial tissue 612 to form a tissue bridge 614.

[0161] As the device 200 endothelializes, the tissue 612 can slowly fill and occlude the openings 252 of the cover 250. This can reduce the amount of regurgitant blood flow through the septal member 202 during ventricular contraction. In other words, as the implant 200 endothelializes, acute regurgitant blood flow through the septal member 202 at the time of implantation can be slowly reduced over a period of, for example, days, weeks, or months. For example, in a patient in which the regurgitant blood flow through the septal member 202 at the time of deployment of the device 200 corresponds to moderate to severe mitral regurgitation (e.g., corresponds to an angiographic grading of MR > 3+), the blood flow through the device can be reduced over a period of, for example, 7 days, two weeks, one month, three months, six months, etc., such that it corresponds to mild to moderate regurgitation (e.g., corresponds to MR < 2+), mild regurgitation (e.g., corresponds to MR < 1+), trivial regurgitation, or no regurgitation.

[0162] In another example, in a patient in which the regurgitant blood flow through the septal member 202 at the time of deployment of the device 200 corresponds to severe mitral regurgitation (e.g., corresponds to an angiographic grading of MR > 4+), the blood flow through the device can be reduced over a period of, for example, 7 days, two weeks, one month, three months, six months, etc., such that it corresponds to mild to moderate regurgitation (e.g., MR < 2+), mild regurgitation (e.g., MR < 1+), trivial regurgitation, or no regurgitation.

[0163] In another example, in patients in which regurgitant blood flow through the spacer member is 15% to 30% of left ventricular stroke volume when the device 200 is deployed, the blood flow through the spacer member can be reduced to 5% to 20% of left ventricular stroke volume, or 0% of left ventricular stroke volume (e.g., no blood flow through the device) over a period of time, e.g., 7 days, two weeks, one month, three months, six months, etc.

[0164] In another example, the device 200 can be configured such that the regurgitant blood flow through the spacer member 202 is reduced to 0% (e.g., no blood flow through the spacer member) over a period of time, e.g., one day, 7 days, two weeks, one month, three months, six months, etc. In another example, the device 200 can be configured such that the regurgitant blood flow through the spacer member 202 is reduced by 100%, 90%, 80%, 70%, 60%, 50%, 40%, or 30% compared to the amount of regurgitant blood flow through the device at implantation over a period of time, e.g., one day, 7 days, two weeks, one month, three months, or six months.

[0165] Compared to existing devices for treating valvular regurgitation, such as mitral valve regurgitation, the prosthetic spacer device embodiments herein can provide significant advantages. For example, by providing a pathway for acute regurgitant blood flow through the spacer device (the pathway shrinking over time), the disclosed spacer device can reduce the pressure on the left ventricle associated with sudden reductions in mitral valve regurgitation. This can allow the disclosed device to be used, for example, in patients with LVEF < 20%, which is contraindicated for many existing treatment devices due to the risk of heart failure. Additionally, the slow reduction in regurgitant blood flow through the device as the covering endothelializes can allow the heart longer time to adjust to the higher load on the left ventricle. This can reduce the risk of left ventricular overload, which can lead to heart failure or patient death.

[0166] General Considerations

[0167] For the purposes of the description, certain aspects, advantages and novel features of the disclosed implementations are described. The disclosed methods, devices, and systems should not be construed as limiting in any specific respect. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations alone and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed implementations require the presence of any particular advantage or solve any particular problem.

[0168] Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily recognizable by one of ordinary skill in the art.

[0169] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language.

[0170] As used herein, the term "proximal" refers to a location, direction, or portion of a device that is closer to a user and further from an implant site. As used herein, the term "distal" refers to a location, direction, or portion of a device that is further from a user and closer to an implant site. Thus, for example, proximal movement of a device is movement of the device away from an implant site and toward a user (e.g., out of a patient's body), while distal movement of a device is movement of the device away from a user and toward an implant site (e.g., into a patient's body). Unless explicitly defined otherwise, the terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions.

[0171] As used herein, the term "about" means the recited value and any value within 10% of the recited value. For example, "about 100 degrees" means any value between 90-110 degrees (including 90 and 110 degrees).

[0172] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the examples described herein are only illustrative of the preferred embodiments and should not be considered limiting the scope of the disclosure. Rather, the scope of the disclosure is broader than the examples, and includes other possible embodiments.

Claims

1. An implantable prosthetic device, the implantable prosthetic device comprising: a spacer member configured to be disposed between a first leaflet and a second leaflet of a native heart valve, the native heart valve being between a first chamber and a second chamber of a heart; a first anchor member; a second anchor member; wherein the first anchor member and the second anchor member are coupled to the spacer member; a plurality of clasps, wherein one of the plurality of clasps is connected to each of the anchor members, wherein the clasps are configured to capture the leaflets to secure the leaflets to the anchor members such that the spacer member is held between the leaflets; and a covering disposed over the spacer member and the plurality of clasps; wherein the covering is disposed over the first anchor member, extends from the first anchor member on a distal end of the implantable prosthetic device to the second anchor member, and is disposed over the second anchor member; wherein the covering is made of a porous material such that the covering is permeable to blood flow; wherein, upon implantation of the prosthetic device, the spacer member is configured to provide a flow path between the first chamber and the second chamber through the prosthetic device when the leaflets are captured between the anchor members and the spacer member such that blood can regurgitatively flow through the spacer member from the first chamber to the second chamber.

2. The implantable prosthetic device of claim 1, wherein the spacer and the plurality of anchor members comprise a mesh structure comprising a plurality of filaments woven together.

3. The implantable prosthetic device of claim 1, wherein the covering comprises a polyester fabric, a felt, a gauze, a polytetrafluoroethylene material, or an ultra-high molecular weight polyethylene material (UHMWPE).

4. The implantable prosthetic device of claim 1, wherein the covering comprises a polyethylene terephthalate material.

5. The implantable prosthetic device of claim 1, wherein: the first chamber is a left ventricle and the second chamber is a left atrium; and the spacer member and the covering are configured to allow a regurgitant blood flow through the device from the left ventricle to the left atrium that is 5% to 30% of a left ventricular stroke volume of the left ventricle when the device is implanted.

6. The implantable prosthetic device of claim 5, wherein: the native heart valve is a mitral valve; the covering is configured to promote tissue ingrowth such that, over a period of one month to six months, a regurgitant blood flow through the device from the second chamber to the first chamber decreases from an amount equivalent to a mitral regurgitation having an angiographic grading of MR > 3+ when the device is implanted to an amount equivalent to a mitral regurgitation having an angiographic grading of MR < 2+.

7. An implantable prosthetic device, the implantable prosthetic device comprising: a spacer member configured to be disposed between a first leaflet and a second leaflet of a native mitral valve, the native mitral valve being between a left atrium and a left ventricle of a heart; a covering made of a porous material such that the covering is permeable to blood flow, the covering being arranged on the spacer member; a first anchor member; a second anchor member; wherein the first and second anchor members are coupled to the spacer member and configured to capture the leaflets between the respective anchor members and the spacer member such that the prosthetic device is held between the leaflets; wherein the covering is arranged on the first anchor member, extends from the first anchor member on a distal end of the implantable prosthetic device to the second anchor member, and is arranged on the second anchor member; wherein upon implantation of the prosthetic device, the spacer member is configured to provide a flow path between the left atrium and the left ventricle through the prosthetic device when the leaflets are captured between the anchor members and the spacer member such that blood can regurgitatively flow from the left ventricle to the left atrium through the spacer member; and wherein the regurgitant blood flow through the spacer member is equivalent to a contrast grading of mitral regurgitation of MR > 2+.

8. The implantable prosthetic device of claim 7, wherein the spacer member comprises a porous body.

9. The implantable prosthetic device of claim 8, wherein the porous body comprises a wire mesh.

10. The implantable prosthetic device of any one of claims 7-9, wherein the regurgitant blood flow through the device from the left ventricle to the left atrium is 5% to 30% of the left ventricular stroke volume of the left ventricle at the time the device is implanted.

11. The implantable prosthetic device of claim 7, wherein: the regurgitant blood flow through the device from the left ventricle to the left atrium decreases from 15% to 30% of the left ventricular stroke volume of the left ventricle at the time the device is implanted to 0% to 20% of the left ventricular stroke volume of the left ventricle over a period of one month to six months.

12. The implantable prosthetic device of claim 7, wherein: the regurgitant blood flow through the device from the left ventricle to the left atrium decreases from an amount equivalent to a contrast grading of mitral regurgitation of MR > 3+ at the time the device is implanted to an amount equivalent to a contrast grading of mitral regurgitation of MR < 2+ over a period of one month to six months.

13. The implantable prosthetic device of claim 7, wherein the prosthetic device is configured to allow a regurgitant blood flow through the spacer member having an amount equivalent to a contrast grading of mitral regurgitation of MR > 3+.

14. The implantable prosthetic device of claim 7, wherein the prosthetic device is configured to allow a regurgitant blood flow through the spacer member having an amount equivalent to a contrast grading of mitral regurgitation of MR > 4+.

Images