Systems, structures, and methods for aortic valve procedures

Abstract

One or more systems, structures, and / or methods are provided. An aortic root repair system may include a first structure including a first tube, a ring extending circumferentially along the first tube and configured to be coupled to ventricular tissue of a patient, and a first plurality of protrusions, extending from the first tube. The first plurality of protrusions may include a first protrusion configured to be coupled to first aortal tissue of an aorta of the patient, and a second protrusion configured to be coupled to second aortal tissue of the aorta. The aortic root repair system may include a second structure including a second tube, and a second plurality of protrusions, extending from a first side of the second tube, including a third protrusion configured to be coupled to the first protrusion and the second protrusion.

Description

SYSTEMS, STRUCTURES, AND METHODS FOR AORTIC VALVE PROCEDURESRELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 714,898, filed on November 1 , 2024, entitled “Aortic Valve Assist Device,” which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Aortic valve disease is a common cardiac condition that may necessitate surgical intervention. Various reconstructive and replacement techniques, such as valve sparing root replacement and Ross procedure, have been developed to restore valve function and / or improve long-term outcomes.SUMMARY

[0003] In accordance with the present disclosure, one or more systems, structures, and / or methods are provided. An aortic root repair system may include a first structure including a first tube, a ring extending circumferentially along the first tube and configured to be coupled to ventricular tissue of a patient, and / or a first plurality of protrusions extending from the first tube. The first plurality of protrusions may include a first protrusion configured to be coupled to first aortal tissue of an aorta of the patient, and a second protrusion configured to be coupled to second aortal tissue of the aorta. The aortic root repair system may include a second structure including a second tube, and a second plurality of protrusions, extending from a first side of the second tube, including a third protrusion configured to be coupled to the first protrusion and the second protrusion.

[0004] In some examples, a method for valve sparing root replacement is provided. A ring of a first structure may be coupled to ventricular tissue of a patient. A first protrusion of the first structure may be coupled to first aortal tissue of an aorta of the patient. A second protrusion of the first structure may2024-043-02 1be coupled to second aortal tissue of the aorta. A second structure may be coupled to the first structure. A left coronary artery may be coupled to the second structure. A right coronary artery may be coupled to the second structure.

[0005] In some examples, a method for a Ross procedure is provided. Sutures may be coupled to a left ventricular outflow tract of a patient. An autograft valve may be coupled to at least one of an aortic annulus or the left ventricular outflow tract. The sutures may be coupled to a ring of a first structure. A first protrusion of the first structure may be coupled to a first commissure of the autograft valve. A second protrusion of the first structure may be coupled to a second commissure of the autograft valve. The autograft valve may be coupled to a first side of a tube. A left coronary artery may be coupled to a first sinus of the autograft valve. A right coronary artery may be coupled to a second sinus of the autograft valve. A second side of the tube may be coupled to an ascending aorta.DESCRIPTION OF THE DRAWINGS

[0006] While the techniques presented herein may be embodied in alternative forms, the particular embodiments illustrated in the drawings are only a few examples that are supplemental of the description provided herein. These embodiments are not to be interpreted in a limiting manner, such as limiting the claims appended hereto.

[0007] Fig. 1 A is an illustration of a first structure of an aortic root repair system, in accordance with some embodiments.

[0008] Fig. 1 B is an illustration of a ring and support structures of a first structure of an aortic root repair system, in accordance with some embodiments.

[0009] Fig. 1C is an illustration of a ring and support structures of a first structure of an aortic root repair system, in accordance with some embodiments.2024-043-02 2

[0010] Fig. 1 D is an illustration of a ring and support structures of a first structure of an aortic root repair system, in accordance with some embodiments.

[0011] Fig. 1 E is an illustration of a first structure of an aortic root repair system, in accordance with some embodiments.

[0012] Fig. 1 F is an illustration of a first structure of an aortic root repair system, in accordance with some embodiments.

[0013] Fig. 1G is an illustration of a first structure of an aortic root repair system, in accordance with some embodiments.

[0014] Fig. 1 H is an illustration of a second structure of an aortic root repair system, in accordance with some embodiments.

[0015] Fig. 11 is an illustration of a second structure of an aortic root repair system, in accordance with some embodiments.

[0016] Fig. 1 J is an illustration of a first structure coupled to a second structure in an aortic root repair system, in accordance with some embodiments.

[0017] Fig. 1 K is an illustration of a first structure coupled to a second structure in an aortic root repair system, in accordance with some embodiments.

[0018] Fig. 1 L is an illustration of sutures between a first structure and a second structure in an aortic root repair system, in accordance with some embodiments.

[0019] Fig. 2A illustrates a dissection process performed on a heart of a patient, in accordance with some embodiments.

[0020] Fig. 2B illustrates exposure of ventricular tissue of a patient, in accordance with some embodiments.

[0021] Fig. 20 illustrates subannulus sutures coupled to ventricular tissue of a patient, in accordance with some embodiments.

[0022] Fig. 2D illustrates subannulus sutures coupled to a first structure, in accordance with some embodiments.2024-043-02 3

[0023] Fig. 2E illustrates a first structure coupled to aortic tissue of an aortic valve, in accordance with some embodiments.

[0024] Fig. 2F illustrates a second structure advancing toward a first structure, in accordance with some embodiments.

[0025] Fig. 2G illustrates a second structure coupled to a first structure, in accordance with some embodiments.

[0026] Fig. 3 is a flow chart illustrating an example method, in accordance with some embodiments.

[0027] Fig. 4 is a flow chart illustrating an example method, in accordance with some embodiments.DETAILED DESCRIPTION

[0028] Subject matter will now be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific example embodiments. This description is not intended as an extensive or detailed discussion of known concepts. Details that are known generally to those of ordinary skill in the relevant art may have been omitted, or may be handled in summary fashion.

[0029] The following subject matter may be embodied in a variety of different forms, such as methods, devices, components, and / or systems. Accordingly, this subject matter is not intended to be construed as limited to any example embodiments set forth herein. Rather, example embodiments are provided merely to be illustrative. Such embodiments may, for example, take the form of medicine, hardware, software, firmware, or any combination thereof.

[0030] One or more systems, structures, and / or techniques for aortic valve procedures are provided. As access to cross sectional imaging is expanding, more people are being diagnosed with aortic aneurysms. The aortic root is a relatively complex portion of the thoracic aorta due to a complex nature of the aortic valve and / or coronary arteries in the aortic root. Aneurysms of the aortic root tend to affect younger patients and / or may run in families. Treating2024-043-02 4patients with operations, such as a valve sparing root replacement operation, that spare their native and / or living aortic valve rather than replacing the valve with an artificial one may provide for improved outcomes, increased lifetime of the valve as compared with an artificial valve, and / or reduced likelihood of failure. However, valve sparing root replacement operations are not widely adopted due to the complexity of the operation. For example, a valve sparing root replacement operation may require a significant amount of tailoring of graft material by an operating surgeon. Alternatively and / or additionally, a reimplantation portion of the operation may require complex suturing within a cylinder of the graft which may be difficult for surgeons to learn and / or perform.

[0031] In accordance with some embodiments herein, an aortic root repair system is provided which includes a first structure (e.g., an annuloplasty crown structure) including a first tube, a ring extending circumferentially along the first tube and configured to be coupled to ventricular tissue of a patient, and / or a first plurality of protrusions extending from the first tube. The first plurality of protrusions may include a first protrusion configured to be coupled to first aortal tissue (e.g., a first commissure) of an aorta of the patient, and a second protrusion configured to be coupled to second aortal tissue (e.g., a second commissure) of the aorta. The aortic root repair system may include a second structure (e.g., a structure with sinuses) including a second tube, and / or a second plurality of protrusions (e.g., sinus-shaped protrusions), configured to be coupled to the first plurality of protrusions. In some examples, the first plurality of protrusions and / or the second plurality of protrusions may be supported and / or reinforced with support structures to provide improved structural support to the aortic valve of the patient. The aortic root repair system may deconstruct the root replacement such that some or all of the native valve re-implantation may be performed with more direct visualization of an aortic valve being secured to the first structure (e.g., the annuloplasty crown structure) before the second structure (e.g., a structure with sinuses) is coupled to the first structure. The aortic root repair system may provide improved alignment of a geometric annulus and / or insertion point of native valve leaflets with a prosthetic ventriculo-aortic2024-043-02 5junction that provides for reconstruction with improved durability. Alternatively and / or additionally, the aortic root repair system may provide a more natural shape of a graft connection with a tighter fit at commissures of the aortic root, as compared with some systems with exceedingly bulgy anastomosis that may rely upon relatively weak native aortic tissue for structural stability and / or physiologic function.

[0032] In some examples, the first structure (e.g., the annuloplasty crown structure) may be used in a Ross procedure, which may provide for a more consistent method of annulus stabilization and / or may provide improved preservation of annulus function by allowing movement throughout the phases of the cardiac cycle, as compared with some systems that use a heavy suture tied over a dilator or use a stiff ring of graft material tied around the outside of an aortic annulus and / or left ventricular outflow tract. The first structure may allow for broader application of the Ross procedure to patients with a dilated aortic annulus and / or a more consistent and / or reproducible way to perform the Ross operation. Alternatively and / or additionally, the first structure (and / or the second structure) may be used for aortic valve repair support, which may provide for improved maintenance of root and / or annulus physiology while achieving desired annulus reduction affect.

[0033] Figs. 1 A-1 L illustrate aspects of an aortic root repair system 100, in accordance with some embodiments. The aortic root repair system 100 may comprise a first structure 102 (e.g., an annuloplasty crown structure) and / or a second structure 122 (e.g., a structure with sinuses) that may be coupled to the first structure 102. In some examples, the first structure 102 may be used in conjunction with the second structure 122, such as for a valve sparing root replacement operation. In some examples, the first structure 102 may be used as a standalone item (without the second structure 122, for example), such as for a Ross procedure.

[0034] Fig. 1 A illustrates a perspective view of the first structure 102, in accordance with some embodiments. The first structure 102 may comprise a first tube 104, a ring 106, and / or a first plurality of protrusions extending from the first tube 104. In some examples, a protrusion of the first plurality of protrusions is configured to be coupled (e.g., sutured) to and / or to support2024-043-02 6tissue (e.g., a commissure) of an aorta or an autograft valve. In some examples, the first plurality of protrusions may comprise a set of three protrusions (for a tricuspid valve, for example), such as shown in Fig. 1 A. Protrusions of the set of three protrusions may be arranged at about 120 degrees of separation. Alternatively and / or additionally, the first plurality of protrusions may comprise a set of two protrusions (for a bicuspid valve, for example). Protrusions of the set of two protrusions may be arranged at about 180 degrees of separation. In some examples, the first plurality of protrusions (e.g., the set of three protrusions) may comprise a first protrusion 108, a second protrusion 1 10, and / or a third protrusion 112.

[0035] In some examples, the first tube 104 may comprise fabric (e.g., a tubular body of fabric), such as biocompatible fabric. The fabric of the first tube 104 may comprise polyethylene terephthalate (PET) (e.g., Dacron ®). Alternatively and / or additionally, the fabric of the first tube 104 may comprise expanded polytetrafluoroethylene (ePTFE) and / or one or more other biocompatible materials. In some examples, the ring 106 may extend circumferentially along the first tube 104. For example, the ring 106 may be continuous so as to extend along all of a circumference of the first tube 104, or the ring 106 may be discontinuous or have a break so as to extend along some but not all of the circumference of the first tube 104. In some examples, the ring 106 may be embedded in and / or enclosed by the fabric of the first tube 104. For example, the ring 106 may be disposed between an inner layer of fabric of the first tube 104 and an outer layer of fabric of the first tube 104. In some examples, the ring 106 may provide structural reinforcement, shape retention, and / or positional stability to the first tube 104.

[0036] In some examples, the first plurality of protrusions may comprise fabric, such as biocompatible fabric. The fabric of the first plurality of protrusions may comprise PET (e.g., Dacron), ePTFE, and / or one or more other biocompatible materials. In some examples, each protrusion of one, some, or all of the first plurality of protrusions may comprise a support structure (e.g., support structures 108i, 110i, and / or 112i shown in Figs. 1 B- 1 D) that may provide structural reinforcement, shape retention, and / or positional stability to the protrusion.2024-043-02 7

[0037] The first structure 102 may have a diameter D1 . The diameter D1 may correspond to a distance between opposite sides of an inner surface of the first tube 104. The diameter D1 may be between about 20 millimeters (mm) to about 40 mm, and / or may be another suitable value. The first structure 102 may have a height H1 . The height H1 may correspond to a distance between a bottom of the first tube 104 and a top of a protrusion of the first plurality of protrusions. The height H1 may be between about 20 mm to about 40 mm, and / or may be another suitable value. In some examples, the height H1 may be about equal to the diameter D1 . In some examples, the first structure 102 may be available in multiple sizes, such as by providing a first plurality of structures corresponding to the first structure 102 in different sizes. For example, the first plurality of structures may comprise a first sized structure 102 having a diameter D1 of about 28 mm (and / or a height H1 of about 28 mm), a second sized structure 102 having a diameter D1 of about 30 mm (and / or a height H1 of about 30 mm), a third sized structure 102 having a diameter D1 of about 32 mm (and / or a height H1 of about 32 mm), a fourth sized structure 102 having a diameter D1 of about 34 mm (and / or a height H1 of about 34 mm), and / or one or more other sized structures.

[0038] Fig. 1 B illustrates an internal structural view of the first structure 102, in accordance with some embodiments. In some examples, the ring 106 may comprise a coil (e.g., a spiral and / or helical shaped structure). The ring 106 having the coil and / or having an elastic and / or flexible material may allow the ring 106 to deform (e.g., stretch, compress, etc.) under load and / or return to an original shape when the load is removed. For example, the ring 106 may flex outward during systole to maintain natural motions of an aortic root. In some examples, the coil may comprise a nitinol wire and / or one or more other suitable materials. The first protrusion 108 may comprise a first support structure 108i, the second protrusion 110 may comprise a second support structure 110i, and / or the third protrusion 112 may comprise a third support structure 112i. In some examples, the first support structure 108i may comprise a first portion, of a wire (e.g., nitinol wire and / or other type of wire) of the coil, that extends upwards then downwards and / or has a U-shaped configuration. The second support structure 110i may comprise a second2024-043-02 8portion of the wire that extends upwards then downwards and / or has a II- shaped configuration. The third support structure 112i may comprise a third portion of the wire that extends upwards then downwards and / or has a II- shaped configuration.

[0039] Fig. 1C illustrates an internal structural view of the first structure 102, in accordance with some embodiments. In some examples, the ring 106 may comprise a plurality of wires. For example, the plurality of wires may comprise two wires comprising a wire 1 11 and / or a wire 113. In some examples, one, some, or all of the plurality of wires may comprise nitinol wire and / or one or more other suitable materials. The plurality of wires may deform (e.g., stretch, compress, etc.) under load and / or return to an original shape when the load is removed such that the ring 106 maintains natural motions of an aortic root, such as by flexing outward during systole. In some examples, the plurality of wires may be supported in respective positions relative to each other using wire holders 115a, 115b, and / or 115c. In some examples, the plurality of wires and / or the wire holders 115a, 115b, and / or 115c may be embedded in and / or enclosed by fabric of the first structure 102. For example, the plurality of wires and / or the wire holders 115a, 115b, and / or 115c may be disposed between an inner layer of the fabric 108f and an outer layer of the fabric 108f. In some examples, the first support structure 108i may comprise a first portion of the wire 111 that extends upwards and downwards and / or has a U-shaped configuration and / or a first portion of the wire 113 that extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the first portion of the wire 111 may be greater than an elevation of a top of the first portion of the wire 113. The second support structure 110i may comprise a second portion of the wire 111 that extends upwards and downwards and / or has a U-shaped configuration and / or a second portion of the wire 113 that extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the second portion of the wire 111 may be greater than an elevation of a top of the second portion of the wire 113. The third support structure 112i may comprise a third portion of the wire 111 that extends upwards and downwards and / or has a U-shaped configuration and / or a third portion of the wire 113 that2024-043-02 9extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the third portion of the wire 111 may be greater than an elevation of a top of the third portion of the wire 113.

[0040] Fig. 1 D illustrates an internal structural view of the first structure 102, in accordance with some embodiments. The plurality of wires may comprise three wires comprising a wire 117, a wire 119, and / or a wire 121 . Embodiments are contemplated in which the plurality of wires comprises more than three wires. In some examples, the plurality of wires may be supported in respective positions relative to each other using wire holders 125a, 125b, and / or 125c. In some examples, the plurality of wires and / or the wire holders 125a, 125b, and / or 125c may be embedded in and / or enclosed by fabric of the first structure 102. For example, the plurality of wires and / or the wire holders 125a, 125b, and / or 125c may be disposed between an inner layer of the fabric 108f and an outer layer of the fabric 108f. In some examples, the first support structure 108i may comprise a first portion of the wire 117 that extends upwards and downwards and / or has a U-shaped configuration, a first portion of the wire 119 that extends upwards and downwards and / or has a U- shaped configuration, and / or a first portion of the wire 121 that extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the first portion of the wire 117 and / or an elevation of a top of the first portion of the wire 119 may be greater than an elevation of a top of the first portion of the wire 121 . The second support structure 1 10i may comprise a second portion of the wire 117 that extends upwards and downwards and / or has a U-shaped configuration, a second portion of the wire 119 that extends upwards and downwards and / or has a U-shaped configuration, and / or a second portion of the wire 121 that extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the second portion of the wire 117 and / or an elevation of a top of the second portion of the wire 119 may be greater than an elevation of a top of the second portion of the wire 121 . The third support structure 112i may comprise a third portion of the wire 117 that extends upwards and downwards and / or has a U-shaped configuration, a third portion of the wire 119 that extends upwards and downwards and / or has a U-shaped configuration, and / or a third portion of the2024-043-02 10wire 121 that extends upwards and downwards and / or has a U-shaped configuration. An elevation of a top of the third portion of the wire 117 and / or an elevation of a top of the third portion of the wire 119 may be greater than an elevation of a top of the third portion of the wire 121 .

[0041] In some examples, the first support structure 108i (shown in Figs.1 B-1 D) may be embedded in and / or enclosed by fabric 108f (shown in Figs.1 A and 1 E) of the first protrusion 108. For example, the first support structure 108I may be disposed between an inner layer of the fabric 108f and an outer layer of the fabric 108f. The first support structure 108i may provide structural reinforcement, shape retention, and / or positional stability to the first protrusion 108. The first support structure 108i may be flexible so as to flex inward during diastole to maintain natural motions of an aortic root. In some examples, the first support structure 108i may comprise a nitinol wire and / or one or more other suitable materials.

[0042] In some examples, the second support structure 110i (shown in Figs. 1 B-1 D) may be embedded in and / or enclosed by fabric 1 10f (shown in Figs. 1A and 1 E) of the second protrusion 110. For example, the second support structure 110i may be disposed between an inner layer of the fabric 110f and an outer layer of the fabric 110f. The second support structure 110i may provide structural reinforcement, shape retention, and / or positional stability to the second protrusion 110. The second support structure 110i may be flexible so as to flex inward during diastole to maintain natural motions of an aortic root. In some examples, the second support structure 110i may comprise a nitinol wire and / or one or more other suitable materials.

[0043] In some examples, the third support structure 112i (shown in Figs. 1 B-1 D) may be embedded in and / or enclosed by fabric 1 12f (shown in Figs. 1 A and 1 E) of the third protrusion 112. For example, the third support structure 112i may be disposed between an inner layer of the fabric 112f and an outer layer of the fabric 112f. The third support structure 112i may provide structural reinforcement, shape retention, and / or positional stability to the third protrusion 112. The third support structure 112i may be flexible so as to flex inward during diastole to maintain natural motions of an aortic root. In some2024-043-02 11examples, the third support structure 112i may comprise a nitinol wire and / or one or more other suitable materials.

[0044] Fig. 1 E illustrates a representation of the first tube 104, the ring 106, the support structures 108i, 110i, and 112i, and / or the fabric 108f, 110f, and 1 12f of the first structure 102, in accordance with some embodiments. The fabric 108f, the fabric 110f, and / or the fabric 112f of the first plurality of protrusions may each comprise a fabric cuff (e.g., a flange) for direct suturing to tissue (e.g., a commissure of an aorta or an autograft valve). In some examples, the first tube 104 may comprise crimped fabric 104c, which may be under the ring 106 and / or may be configured to be sutured (e.g., externally sutured) to sub-annular stitches.

[0045] Fig. 1 F illustrates a representation of the first structure 102, in accordance with some embodiments. In some examples, the first tube 104 may define one or more key holes. In some examples, each key hole of the one or more key holes may be positioned under a protrusion of the first plurality of protrusions. The one or more key holes may comprise a first key hole 114a, a second key hole 114b, and / or a third key hole 1 14c. The first key hole 114a may be positioned under the first protrusion 108, the second key hole 114b may be positioned under the second protrusion 110, and / or the third key hole 114c may be positioned under the third protrusion 1 12.

[0046] In some examples, the first tube 104 may comprise one or more hinges to mitigate interference with sewing. The one or more hinges may each provide for increased localized flexibility, such as due, at least in part, to the hinge having a reduced thickness as compared with a thickness of an adjacent portion of the first tube 104, the hinge having a reduced density as compared with a density of an adjacent portion of the first tube 104, and / or the ring 106 being disconnected at the hinge. In some examples, the one or more hinges may permit bending, manipulation, and / or folding of the first tube 104 (by a surgeon, for example) to mitigate interference with sewing and / or obstruction of a needle or suture path. In some examples, the one or more hinges may comprise a hinge 116a, a hinge 116b, a hinge 116c, a hinge 116d, a hinge 116e, and / or a hinge 116f.2024-043-02 12

[0047] Fig. 1G illustrates a representation of the first structure 102, in accordance with some embodiments. In some examples, the first structure 102 may comprise a plurality of interlocking features extending from the first tube 104 and / or protrusions of the first plurality of protrusions. One, some, or all interlocking features of the plurality of interlocking features may be configured to engage the second structure 122 (for coupling the first structure 102 to the second structure 122, for example). In some examples, each interlocking feature of one, some, or all of the plurality of interlocking features may comprise a hook (e.g., the hook may comprise a barb, for example, at a tip of the hook). The plurality of interlocking features may comprise interlocking features 118a, 118b, and / or 118c extending from the first tube 104, interlocking features 118d and / or 118e extending from the first protrusion 108, interlocking features 118f and / or 118g extending from the second protrusion 110, and / or interlocking features 118h and / or 118i extending from the third protrusion 112.

[0048] In some examples, the first structure 102 may comprise one or more first magnets. The one or more first magnets may be disposed in protrusions of the first plurality of protrusions. For example, the one or more first magnets may comprise a first magnet 120a in the first protrusion 108, a second magnet 120b in the second protrusion 1 10, and / or a third magnet 120c in the third protrusion 120c. In some examples, the one or more first magnets may be configured to interact with one or more second magnets in the second structure 122 (for coupling the first structure 102 to the second structure 122, for example).

[0049] Fig. 1 H illustrates a perspective view of the second structure 122, in accordance with some embodiments. The second structure 122 may comprise a second tube 126 and / or a second plurality of protrusions extending from the second tube 126. The second tube 126 may have a first side 123 and / or a second side 124. The second plurality of protrusions may extend from the first side 123 of the second tube 126. The first side 123 of the second tube 126 may correspond to a sinutubular junction. The second side 124 may be coupled to at least one of a graft or an ascending aorta (e.g., distal ascending aorta) of a patient. In some examples, the second tube 1262024-043-02 13may comprise fabric (e.g., a tubular body of fabric), such as biocompatible fabric. The fabric of the second tube 126 may comprise PET (e.g., Dacron). Alternatively and / or additionally, the fabric of the second tube 126 may comprise ePTFE and / or one or more other biocompatible materials.

[0050] In some examples, each protrusion of one, some, and / or all of the second plurality of protrusions has a shape (e.g., a bulbous and / or outwardly curved shape) that matches a shape of a wall of an aortic sinus. In some examples, the second plurality of protrusions may comprise a set of three protrusions (for a tricuspid valve, for example), such as shown in Fig. 1 A. Protrusions of the set of three protrusions may be arranged at about 120 degrees of separation. Alternatively and / or additionally, the second plurality of protrusions may comprise a set of two protrusions (for a bicuspid valve, for example). Protrusions of the set of two protrusions may be arranged at about 180 degrees of separation. In some examples, the second plurality of protrusions (e.g., the set of three protrusions) may comprise a fourth protrusion 128, a fifth protrusion 130, and / or a sixth protrusion 132.

[0051] In some examples, the second plurality of protrusions may comprise fabric, such as biocompatible fabric. The fabric of the second plurality of protrusions may comprise PET (e.g., Dacron), ePTFE, and / or one or more other biocompatible materials. In some examples, each protrusion of one, some, or all of the first plurality of protrusions may comprise a support structure that may provide structural reinforcement, shape retention, and / or positional stability to the protrusion. For example, the fourth protrusion 128 may comprise a fourth support structure 134. In some examples, the fourth support structure 134 may extend along an edge 140 (e.g., a curved and / or scalloped edge) of the fourth protrusion 128 and / or may maintain a shape (e.g., a curved and / or scalloped shape) of the edge 140. The fourth support structure 134 may be embedded in and / or enclosed by fabric of the fourth protrusion 128. For example, the fourth support structure 134 may be disposed between an inner layer of fabric of the fourth protrusion 128 and an outer layer of fabric of the fourth protrusion 128. The fifth protrusion 130 may comprise a fifth support structure 136. In some examples, the fifth support structure 136 may extend along an edge 142 (e.g., a curved and / or scalloped2024-043-02 14edge) of the fifth protrusion 130 and / or may maintain a shape (e.g., a curved and / or scalloped shape) of the edge 142. The fifth support structure 136 may be embedded in and / or enclosed by fabric of the fifth protrusion 130. For example, the fifth support structure 136 may be disposed between an inner layer of fabric of the fifth protrusion 130 and an outer layer of fabric of the fifth protrusion 130. The sixth protrusion 132 may comprise a sixth support structure 138. In some examples, the sixth support structure 138 may extend along an edge 144 (e.g., a curved and / or scalloped edge) of the sixth protrusion 132 and / or may maintain a shape (e.g., a curved and / or scalloped shape) of the edge 144. The sixth support structure 138 may be embedded in and / or enclosed by fabric of the sixth protrusion 132. For example, the sixth support structure 138 may be disposed between an inner layer of fabric of the sixth protrusion 132 and an outer layer of fabric of the sixth protrusion 132.

[0052] The second structure 122 may have a diameter D2. The diameter D2 may correspond to a distance between opposite sides of an inner surface of the second tube 126 (at the first side 123 of the second tube 126, the second side 124 of the second tube 126, and / or between the first side 123 and the second side 124 of the second tube 126, for example). The diameter D2 may be between about 24 mm to about 48 mm, and / or may be another suitable value. At least a portion of the second structure 122 may have a height H2. The height H2 may correspond to a distance between a bottom of a protrusion of the second plurality of protrusions and the first side 123 of the second tube 126 (e.g., the sinutubular junction). The height H2 may be between about 24 mm to about 48 mm, and / or may be another suitable value. In some examples, the height H2 may be about equal to the diameter D2. In some examples, a ratio of the height H2 of the second structure 122 to the height H1 of the first structure 102 may be between about 1 .0:1 .0 to about 1 .4:1.0, may be between about 1.1 :1.0 to about 1 .3:1 .0, and / or may be about 1 .2:1 .0. In some examples, a ratio of the diameter D2 of the second structure 122 to the diameter D1 of the first structure 102 may be between about 1 .0:1.0 to about 1.4:1 .0, may be between about 1 .1 :1 .0 to about 1 .3:1.0, and / or may be about 1 .2:1 .0.2024-043-02 15

[0053] In some examples, the second structure 122 may be available in multiple sizes, such as by providing a second plurality of structures corresponding to the second structure 122 in different sizes. In some examples, structures of the second plurality of structures may be dimensioned to correspond to structures of the first plurality of structures. For example, the second plurality of structures may comprise a fifth sized structure 122 dimensioned to be used in conjunction with the first sized structure 102 (e.g., the fifth sized structure 122 may have a diameter D2 of between about 33 mm to about 34 mm), a sixth sized structure 122 dimensioned to be used in conjunction with the second sized structure 102 (e.g., the sixth sized structure 122 may have a diameter D2 of about 36 mm), a seventh sized structure 122 dimensioned to be used in conjunction with the third sized structure 102 (e.g., the seventh sized structure 122 may have a diameter D2 of between about 38 mm to about 39 mm), an eighth sized structure 122 dimensioned to be used in conjunction with the fourth sized structure 102 (e.g., the eighth sized structure 122 may have a diameter D2 of between about 40 mm to about 41 mm), and / or one or more other sized structures.

[0054] Fig. 11 illustrates a representation of the second structure 122 comprising one or more second magnets, in accordance with some embodiments. The one or more second magnets may be disposed in the second tube 126, in protrusions of the second plurality of protrusions, and / or in a region, of the second structure 122, between the second tube 126 and the second plurality of protrusions. The one or more second magnets may comprise a fourth magnet 146a between (and / or over) the fourth protrusion 128 and the fifth protrusion 130, a fifth magnet 146b between (and / or over) the fourth protrusion 128 and the sixth protrusion 132, and / or a sixth magnet (not shown) between (and / or over) the fifth protrusion 130 and the sixth protrusion 132. In some examples, the one or more second magnets may be configured to interact with the one or more first magnets in the first structure 102 (for coupling the second structure 122 to the first structure 102, for example)

[0055] Fig. 1 J illustrates a representation of the first structure 102 coupled to the second structure 122, in accordance with some embodiments. In some2024-043-02 16examples, the second structure 122 may be positioned in a target position (e.g., the position of the second structure 122 shown in Fig. 1 J) relative to the first structure 102 using the one or more first magnets in the first structure 102 and / or the one or more second magnets in the second structure 122. For example, a magnetic force between the one or more first magnets and the one or more second magnets may pull the second structure 122 toward the target position. In some examples, in response to positioning the second structure 122 in the target position relative to the first structure 102, the second structure 122 may be coupled to the first structure 102, for example, by suturing the second structure 122 to the first structure 102 (via sutures 133, for example).

[0056] In some examples, when the second structure 122 is coupled to the first structure 102 and / or in the target position, the fourth protrusion 128 of the second structure 122 occupies a space between the first protrusion 108 and the second protrusion 1 10 of the first structure 102. The edge 140 (e.g., curved and / or scalloped edge) of the fourth protrusion 128 may be configured to mate with an edge 152 of the first protrusion 108, an edge 154 of the second protrusion 1 10, and / or an edge 156 of a region, of the first tube 104, between the first protrusion 108 and the second protrusion 1 10. In some examples, the fourth protrusion 128 may be coupled to (e.g., sutured to) the first protrusion 108, the second protrusion 1 10, and / or the region between the first protrusion 108 and the second protrusion 110.

[0057] In some examples, when the second structure 122 is coupled to the first structure 102 and / or in the target position, the fifth protrusion 130 of the second structure 122 occupies a space between the first protrusion 108 and the third protrusion 1 12 of the first structure 102. The fifth protrusion 130 may be coupled to (e.g., sutured to) the first protrusion 108, the third protrusion 112, and / or a region, of the first tube 104, between the first protrusion 108 and the third protrusion 1 12. In some examples, when the second structure 122 is coupled to the first structure 102 and / or in the target position, the sixth protrusion 132 of the second structure 122 occupies a space between the second protrusion 1 10 and the third protrusion 1 12 of the first structure 102. The sixth protrusion 132 may be coupled to (e.g., sutured to) the second2024-043-02 17protrusion 110, the third protrusion 112, and / or a region, of the first tube 104, between the second protrusion 110 and the third protrusion 112.

[0058] Fig. 1 K illustrates a representation of the first structure 102 coupled to the second structure 122, in accordance with some embodiments. In some examples, in response to positioning the second structure 122 in the target position relative to the first structure 102 and / or suturing the second structure 122 to the first structure 102, a snap-on element 160 (e.g., a snap-on ring) may be installed around at least a portion of the first tube 104 and / or at least a portion of the second plurality of protrusions of the second structure 122, for example, to secure the second structure 122 to the first structure 102 and / or provide structural reinforcement, shape retention, and / or positional stability to the second structure 122 and / or the first structure 102. In some examples, the snap-on element 160 may comprise one or more pins that are inserted into the one or more key holes of the first structure 102. For example, the one or more pins may comprise a first pin 158 inserted into the first key hole 114a, a second pin (not shown) inserted into the second key hole 114b, and / or a third pin (not shown) inserted into the third key hole 1 14c.

[0059] Fig. 1 L illustrates suturing the second structure 122 to the first structure 102, in accordance with some embodiments. In some examples, sutures 164 may be placed through the first structure 102 and corresponding portions of the second structure 122 in a pre-suturing process. In some examples, the sutures 164 may comprise the sutures 133 shown in Figs. 1 J and 1 K. In some examples, the sutures 164 may comprise sutures between the fourth protrusion 128 of the second structure 122 and the first protrusion 108, the second protrusion 110, and / or a region, of the first tube 104, between the first protrusion 108 and the second protrusion 110. Alternatively and / or additionally, the sutures 164 may comprise sutures between the fifth protrusion 130 of the second structure 122 and the first protrusion 108, the third protrusion 1 12, and / or a region, of the first tube 104, between the first protrusion 108 and the third protrusion 112. Alternatively and / or additionally, the sutures 164 may comprise sutures between the sixth protrusion 132 of the second structure 122 and the second protrusion 110, the third protrusion 112, and / or a region, of the first tube 104, between the second protrusion 110 and2024-043-02 18the third protrusion 112. In some examples, in response to performing the pre-suturing process, the second structure 122 is advanced (e.g., parachuted) along the sutures 164 toward the first structure 102 such that the second structure 122 is positioned at the target position relative to the first structure 102 and / or is joined with the first structure 102. In some examples, in response to the second structure 122 being positioned at the target position relative to the first structure 102 and / or being joined with the first structure 102, the sutures 164 are tied (e.g., tightened and / or knotted) to secure the second structure 122 to the first structure 102.

[0060] Figs. 2A-2G illustrate a scenario 200 in which a valve sparing root replacement procedure (e.g., David’s procedure) is performed using the system 100, in accordance with some embodiments. Fig. 2A illustrates a dissection process performed on a heart 202 of a patient, in accordance with some embodiments. The dissection process may include transecting an aorta of the heart 202 (at a sinutubular junction, for example) to separate an ascending aorta 206 of the aorta from an aortic root 201 of the aorta. In some examples, aortic sinuses (e.g., sinuses of Valsalva) may be incised along a first incision line 222, a second incision line 224, and / or a third incision line 226 (shown as dashed-lines in Fig. 2A).

[0061] In some examples, a left coronary button 230 comprising an origin of a left coronary artery 214 may be separated and / or preserved for later attachment (e.g., reanastomosis) by incising an aortic sinus along a fourth incision line 216. A right coronary button 228 comprising an origin of a right coronary artery 218 may be separated and / or preserved for later attachment by incising an aortic sinus along a fifth incision line 220. In some examples, performing the dissection process may leave leaflets of an aortic valve 208, a first commissure 215 of the aortic valve 208, a second commissure 213 of the aortic valve 208, and / or a third commissure 211 of the aortic valve 208.

[0062] Fig. 2B illustrates the aortic valve 208 after the dissection process is performed, in accordance with some embodiments. The aortic valve 208 may comprise a first leaflet 244 with an edge 244a and / or an edge 244b. The aortic valve 208 may comprise a second leaflet 246 with an edge 246a (adjacent the edge 244b of the first leaflet 244, for example) and / or an edge2024-043-02 19246b. The aortic valve 208 may comprise a third leaflet 248 with an edge 248a (adjacent the edge 246b of the second leaflet 246, for example) and / or an edge 248b (adjacent the edge 244a of the first leaflet 244, for example). The aortic valve 208 may function to transition between a closed state and an open state, for example, due to pressure changes of a cardiac cycle. In the closed state, edges of the first leaflet 244, the second leaflet 246, and / or the third leaflet 248 may join together to form a seal. In the open state, the first leaflet 244, the second leaflet 246, and / or the third leaflet 248 may move towards an aortic wall of the aortic valve 208 to form an orifice.

[0063] In some examples, tissue 242 is manipulated and / or removed to expose ventricular tissue 240 of a left ventricular outflow tract of the heart. A ring of the ventricular tissue 240 around the aortic wall of the aortic valve 208 may be exposed, such as shown in Fig. 2C. In some examples, the ventricular tissue 240 that is exposed may be a subvalvular plane of ventricular tissue of the left ventricular outflow tract. In some examples, the subvalvular plane may correspond to a surface of the left ventricular outflow tract at which the left ventricular outflow tract transitions into the aortic valve 208. In some examples, the subvalvular plane is located under an annulus of the aorta. The annulus may correspond to a ring, along a base of the aortic root 201 , joining basal hinge points (and / or attachments) of the leaflets 244, 246 and / or 248 of the aortic valve 208.

[0064] Fig. 2C illustrates subannulus sutures 252 coupled to the left ventricular outflow tract under the aortic valve 208, in accordance with some embodiments. The subannulus sutures 252 may be placed within the left ventricular outflow tract and / or extended out (under the aortic valve 208, for example) through the ventricular tissue 240. In some examples, the subannulus sutures 252 may be sewn through pledgets 254 to distribute tension and / or mitigate tearing of tissue. The pledgets 254 may be arranged along an inner surface of the left ventricular outflow tract. In some examples, the subannulus stutures 252 may be sewn into the left ventricular outflow tract through an opening 231 in the aortic valve 208.

[0065] Fig. 2D illustrates coupling the subannulus sutures 252 extending from the ventricular tissue 240 to the ring 106 of the first structure 102, in2024-043-02 20accordance with some embodiments. In some examples, a suitably sized version of the first structure 102 may be selected from among the first plurality of structures (e.g., at least one of the first sized structure 102, the second sized structure 102, the third sized structure 102, the fourth sized structure 102, etc.) based upon an annulus size measurement of the patient (which may be performed using a valve sizer and / or other technique). In some examples, the subannulus sutures 252 may be passed through a portion, of the first tube 104, over the ring 106. After passing the subannulus sutures 252 through the portion of the first tube 104, the first structure 102 may be advanced (e.g., parachuted) toward the ventricular tissue 240 (in a direction 256, for example) to couple the ring 106 to the ventricular tissue 240, and / or the subannulus sutures 252 may be tied (e.g., tightened and / or knotted) to secure the ring 106 to the ventricular tissue 240.

[0066] Fig. 2E illustrates the aortic valve 208 being sutured to the first structure 102, in accordance with some embodiments. For example, a suture line 233 may be used to suture the aortic valve 208 (e.g., a base of the aortic valve 208 at a level of leaflet insertion and / or commissures of the aortic valve) to fabric of the first structure 102, such as fabric of the first plurality of protrusions (e.g., the fabric 108f of the first protrusion 108, the fabric 110f of the second protrusion 110, and / or the fabric 112f of the third protrusion 112) and / or fabric, of the first tube 104, in regions between protrusions of the first plurality of protrusions. The first protrusion 108 may be coupled (using the suture line 233, for example) to first aortal tissue (e.g., the first commissure 215) of the aortic valve 208. The second protrusion 110 may be coupled (using the suture line 233, for example) to second aortal tissue (e.g., the second commissure 213) of the aortic valve 208. The third protrusion 112 may be coupled (using the suture line 233, for example) to third aortal tissue (e.g., the third commissure 211 ) of the aortic valve 208. In some examples, the suture line 233 may comprise a continuous suture line (and / or discontinuous suture lines) that runs circumferentially along the first structure 102, the annulus and / or the commissures of the aortic valve, such as shown in Fig. 2F. In some examples, the suture line 233 may comprise a line of polypropylene and / or other material.2024-043-02 21

[0067] In some examples, sutures 235 (e.g., the sutures 164 shown in Fig. 1 L) may be placed through the first structure 102 and corresponding portions of the second structure 122 in a pre-suturing process. In some examples, a suitably sized version of the second structure 122 may be selected from among the second plurality of structures (e.g., at least one of the fifth sized structure 122, the sixth sized structure 122, the seventh sized structure 122, the eighth sized structure 122, etc.) based upon a size (e.g., at least one of 28 mm diameter D1 , 30 mm diameter D1 , 32 mm diameter D1 , 34 mm diameter D1 , etc.) of the first structure 102. In some examples, in response to performing the pre-suturing process, the second structure 122 is advanced (e.g., parachuted) along the sutures 235 toward the first structure 102 such that the second structure 122 is positioned at the target position relative to the first structure 102 and / or is joined with the first structure 102.

[0068] Fig. 2F illustrates the second structure 122 being advanced toward the first structure 102 along a direction 237, in accordance with some embodiments. In some examples, the second structure 122 may be positioned at the target position (e.g., the position of the second structure 122 shown in Fig. 2G) and / or joined with the first structure 102 using the one or more first magnets and / or the one or more second magnets (e.g., a magnetic force between the one or more first magnets and the one or more second magnets may pull the second structure 122 toward the target position relative to the first structure 102). In some examples, the second structure 122 may be positioned at the target position and / or joined with the first structure 102 using the plurality of interlocking features, such as interlocking features 118a, 118b, 118c, 118d, 1 18e, 118f, 118g, 118h and / or 118i shown in Fig. 1 G (e.g., the plurality of interlocking features may engage the second structure 122 to secure the second structure 122 in the target position relative to the first structure 102). In some examples, the second structure 122 may be positioned at the target position and / or joined with the first structure 102 using the snap-on element 160 (shown in Fig. 1 K) comprising one or more pins that may be inserted into the one or more key holes (shown in Fig. 1 F) of the first structure 102. In some examples, in response to the second structure 122 being positioned at the target position relative to the first structure 102 and / or2024-043-02 22being joined with the first structure 102, the sutures 235 are tied (e.g., tightened and / or knotted) to secure the second structure 122 to the first structure 102 (such as shown in Fig. 2G).

[0069] Fig. 2G illustrates the left coronary button 230 and / or the right coronary button 228 coupled to the fifth protrusion 130 and / or the sixth protrusion 132, respectively, in accordance with some embodiments. In some examples, the fourth protrusion 128, the fifth protrusion 130, and / or the sixth protrusion 132 may be prosthetic and / or reinforced aortic sinuses (e.g., sinuses of Valsalva). In some examples, the left coronary button 230 and / or the right coronary button 228 may be coupled to the fifth protrusion 130 and / or the sixth protrusion 132 in response to the second structure 122 being coupled to the first structure 102 (using the sutures 235, for example). In some examples, the left coronary button 230 is coupled to the fifth protrusion 130 by forming an opening in the fifth protrusion 130, and / or coupling the left coronary button 230 to a boundary of the opening in the fifth protrusion 130. In some examples, the right coronary button 228 is coupled to the sixth protrusion 132 by forming an opening in the sixth protrusion 132, and / or coupling the right coronary button 228 to a boundary of the opening in the sixth protrusion 132.

[0070] In some examples, distal graft anastomosis may be performed. The distal graft anastomosis may comprise coupling the second side 124 of the second tube 126 of the second structure 122 to the ascending aorta 206 (shown in Fig. 2A) of the patient. Alternatively and / or additionally, distal graft anastomosis may comprise coupling a graft, that is coupled to the second side 124 of the second tube 126, to the ascending aorta 206. In some examples, the graft may comprise PET (e.g., Dacron), ePTFE and / or one or more other biocompatible materials. In some examples, the distal graft anastomosis (to complete the aortic root repair, for example) may be performed in response to confirming homeostasis via pressurizing and / or assessing connections of the first structure 102, the second structure 122, the aortic valve 208, the left coronary artery 214, and / or the right coronary artery 218.2024-043-02 23

[0071] An embodiment of performing a valve sparing root replacement procedure is illustrated by an example method 300 of Fig. 3. At 302, a ring (e.g., the ring 106) of a first structure (e.g., the first structure 102) may be coupled to ventricular tissue (e.g., the ventricular tissue 140) of a patient. At 304, a first protrusion (e.g., the first protrusion 108) may be coupled to first aortal tissue (e.g., the first commissure 215) of an aorta of the patient. At 306, a second protrusion (e.g., the second protrusion 110) may be coupled to second aortal tissue (e.g., the second commissure 213) of the aorta. At 308, a second structure (e.g., the second structure 122) may be coupled to the first structure. At 310, a left coronary artery (e.g., the left coronary artery 214) may be coupled to the second structure. At 312, a right coronary artery (e.g., the right coronary artery 218) may be coupled to the second structure.

[0072] An embodiment of performing a Ross procedure using the first structure 102 is illustrated by an example method 400 of Fig. 4. At 402, sutures may be coupled to a left ventricular outflow tract of a patient, such as using one or more of the techniques provided herein with respect to coupling the subannulus sutures 252 to the left ventricular outflow tract. The sutures may be placed within the left ventricular outflow tract and / or extended out through ventricular tissue (e.g., the ventricular tissue 240) of the patient. In some examples, the sutures may be coupled to the left ventricular outflow tract after excising an aortic valve of the patient. At 404, an autograft valve may be coupled (e.g., sutured) to an aortic annulus of the patient and / or to the left ventricular outflow tract. For example, the autograft valve may be coupled to the aortic annulus and / or the left ventricular outflow tract after the sutures (e.g., the subannulus sutures 252) are coupled to the left ventricular outflow tract at 402. The autograft valve may comprise a harvested pulmonary autograft (excised from the patient, for example). At 406, the sutures (e.g., the subannulus sutures 252) may be coupled to the ring 106 of the first structure 102, such as using one or more of the techniques provided herein with respect to coupling the subannulus sutures 252 to the ring 106 of the first structure 102. In some examples, the sutures may be passed through the first structure 102 and / or tied (e.g., tightened and / or knotted) to secure the first structure 102 against the autograft valve.2024-043-02 24

[0073] At 408, the first protrusion 108 of the first structure 102 may be coupled (e.g., sutured) to a first commissure of the autograft valve. At 410, the second protrusion 110 of the first structure 102 may be coupled (e.g., sutured) to a second commissure of the autograft valve. In some examples, the third protrusion 112 of the first structure 102 may be coupled (e.g., sutured) to a third commissure of the autograft valve. At 412, the autograft valve may be coupled (e.g., sutured) to a first side of a tube (e.g., a cuff of graft). The tube may comprise PET (e.g., Dacron), ePTFE and / or one or more other biocompatible materials. The tube may match an annulus stent in size and / or may include three symmetric markings (at 120-degree intervals, for example) to stabilize and / or reconstruct a sinutubular junction. At 414, a left coronary artery may be coupled to a first sinus of the autograft valve, such as by implanting a left coronary button to the first sinus. At 416, a right coronary artery may be coupled to a second sinus of the autograft valve, such as by implanting a right coronary button to the second sinus. At 418, a second side of the tube may be coupled (e.g., sutured) to an ascending aorta of the patient. In some examples, the second side of the tube may be coupled to the ascending aorta after performing pulmonary homograft reconstruction. In some examples, the second structure 122 may be coupled (e.g., sutured) to the first structure 102 and / or to the autograft valve (e.g., the second plurality of protrusions may be coupled to sinuses of the autograft valve) to reinforce and / or provide support for sinuses of the autograft valve.

[0074] In some examples, the first structure 102 may be used for patients undergoing a relatively isolated aortic valve repair operation without full root replacement (e.g., for patients without a root aneurysm and / or with a dilated annulus), such as by separating and implanting native coronary buttons. Alternatively and / or additionally, the first structure 102 and / or the second structure 122 may be configured such that the first structure 102 may be installed (under the coronary arteries of a patient, for example) without detaching and / or implanting the coronary arteries (e.g., the left coronary artery 214 and / or the right coronary artery 218).

[0075] According to some embodiments, an aortic root repair system is provided. The aortic root repair system includes a first structure including a2024-043-02 25first tube, a ring extending circumferentially along the first tube and configured to be coupled to ventricular tissue of a patient, and a first plurality of protrusions, extending from the first tube, including a first protrusion configured to be coupled to first aortal tissue of an aorta of the patient, and a second protrusion configured to be coupled to second aortal tissue of the aorta; and a second structure including a second tube, and a second plurality of protrusions, extending from a first side of the second tube, including a third protrusion configured to be coupled to the first protrusion and the second protrusion.

[0076] According to some embodiments, a second side of the second tube is configured to be coupled to an ascending aorta of the patient.

[0077] According to some embodiments, the aortic root repair system includes a graft, coupled to a second side of the second tube, configured to be coupled to an ascending aorta of the patient.

[0078] According to some embodiments, the aortic root repair system includes a first magnet in the first protrusion; and a second magnet in the second structure, wherein the first magnet is configured to interact with the second magnet to align the first structure with the second structure.

[0079] According to some embodiments, the first structure includes one or more interlocking features, extending from the first tube, configured to engage the second structure.

[0080] According to some embodiments, the ring includes a coil.

[0081] According to some embodiments, the first plurality of protrusions include three protrusions; and the second plurality of protrusions include three protrusions.

[0082] According to some embodiments, the first plurality of protrusions include two protrusions; and the second plurality of protrusions include two protrusions.

[0083] According to some embodiments, a first space is defined by the first structure between the first protrusion and the second protrusion; and the third2024-043-02 26protrusion occupies the first space when the third protrusion is coupled to the first protrusion and the second protrusion.

[0084] According to some embodiments, the third protrusion includes an edge configured to mate with at least one of an edge of the first protrusion or an edge of the second protrusion.

[0085] According to some embodiments, a method for valve sparing root replacement is provided. The method includes coupling a ring of a first structure to ventricular tissue of a patient; coupling a first protrusion of the first structure to first aortal tissue of an aorta of the patient; coupling a second protrusion of the first structure to second aortal tissue of the aorta; coupling a second structure to the first structure; coupling a left coronary artery to the second structure; and coupling a right coronary artery to the second structure.

[0086] According to some embodiments, the method includes coupling the second structure to an ascending aorta of the patient.

[0087] According to some embodiments, the method includes coupling a first side of a graft to the second structure; and coupling a second side of the graft to an ascending aorta of the patient.

[0088] According to some embodiments, the method includes positioning the second structure in a target position relative to the first structure using a first magnet in the first protrusion and a second magnet in the second structure.

[0089] According to some embodiments, coupling the second structure to the first structure is performed in response to positioning the second structure in the target position.

[0090] According to some embodiments, coupling the second structure to the first structure includes coupling a third protrusion, of the second structure, to the first protrusion, the second protrusion, and a region, of the first structure, between the first protrusion and the second protrusion.

[0091] According to some embodiments, the method includes forming a first opening in a third protrusion of the second structure, wherein coupling the left coronary artery to the second structure includes coupling a left coronary2024-043-02 27button to a boundary of the first opening; and forming a second opening in a fourth protrusion of the second structure, wherein coupling the right coronary artery to the second structure includes coupling a right coronary button to a boundary of the second opening.

[0092] According to some embodiments, coupling the ring of the first structure to the ventricular tissue of the patient includes suturing the ring of the first structure to the ventricular tissue.

[0093] According to some embodiments, coupling the first protrusion of the first structure to the first aortal tissue of the aorta of the patient includes suturing the first protrusion of the first structure to the first aortal tissue.

[0094] According to some embodiments, coupling the second protrusion of the first structure to the second aortal tissue of the aorta includes suturing the second protrusion of the first structure to the second aortal tissue.

[0095] According to some embodiments, coupling the second structure to the first structure includes suturing the second structure to the first structure.

[0096] According to some embodiments, a method for a Ross procedure is provided. The method includes coupling sutures to a left ventricular outflow tract of a patient; coupling an autograft valve to at least one of an aortic annulus or the left ventricular outflow tract; coupling the sutures to a ring of a first structure; coupling a first protrusion of the first structure to a first commissure of the autograft valve; coupling a second protrusion of the first structure to a second commissure of the autograft valve; coupling the autograft valve to a first side of a tube; coupling a left coronary artery to a first sinus of the autograft valve; coupling a right coronary artery to a second sinus of the autograft valve; and coupling a second side of the tube to an ascending aorta.

[0097] According to some embodiments, the method includes performing pulmonary homograft reconstruction.

[0098] According to some embodiments, coupling the first protrusion of the first structure to the first commissure of the autograft valve includes suturing the first protrusion of the first structure to the first commissure of the autograft valve.2024-043-02 28

[0099] According to some embodiments, coupling the second protrusion of the first structure to the second commissure of the autograft valve includes suturing the second protrusion of the first structure to the second commissure of the autograft valve.

[0100] According to some embodiments, coupling the autograft valve to the first side of the tube includes suturing the autograft valve to the first side of the tube.

[0101] According to some embodiments, coupling the second side of the tube to the ascending aorta includes suturing the second side of the tube to the ascending aorta.

[0102] According to some embodiments, a method is provided which includes at least one aspect as described in the present disclosure and / or shown in the figures.

[0103] According to some embodiments, a method is provided which includes plural aspects as described in the present disclosure and / or shown in the figures.

[0104] According to some embodiments, a system is provided which includes at least one aspect as described in the present disclosure and / or shown in the figures.

[0105] According to some embodiments, a system is provided which includes plural aspects as described in the present disclosure and / or shown in the figures.

[0106] Unless specified otherwise, “first,” “second,” and / or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first object and a second object generally correspond to object A and object B or two different or two identical objects or the same object.

[0107] Moreover, "example" is used herein to mean serving as an instance, illustration, etc., and not necessarily as advantageous. As used herein, "or" is intended to mean an inclusive "or" rather than an exclusive "or".2024-043-02 29In addition, "a" and "an" as used in this application are generally be construed to mean "one or more" unless specified otherwise or clear from context to be directed to a singular form. Also, at least one of A and B and / or the like generally means A or B or both A and B. Furthermore, to the extent that "includes", "having", "has", "with", and / or variants thereof are used in either the detailed description or the claims, such terms are intended to be inclusive in a manner similar to the term "comprising”.

[0108] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing at least some of the claims.

[0109] Furthermore, the claimed subject matter may be implemented as a method, apparatus, or article of manufacture using standard programming and / or engineering techniques to produce software, firmware, hardware, or any combination thereof to control a computer to implement the disclosed subject matter. The term "article of manufacture" as used herein is intended to encompass a computer program accessible from any computer- readable device, carrier, or media. Of course, many modifications may be made to this configuration without departing from the scope or spirit of the claimed subject matter.

[0110] Various operations of embodiments are provided herein. In an embodiment, one or more of the operations described may constitute computer readable instructions stored on one or more computer and / or machine readable media, which if executed will cause the operations to be performed. The order in which some or all of the operations are described should not be construed as to imply that these operations are necessarily order dependent. Alternative ordering will be appreciated by one skilled in the art having the benefit of this description. Further, it will be understood that not all operations are necessarily present in each embodiment provided herein. Also, it will be understood that not all operations are necessary in some embodiments.2024-043-02 30

[0111] Also, although the disclosure has been shown and described with respect to one or more implementations, equivalent alterations and modifications will occur to others skilled in the art based upon a reading and understanding of this specification and the annexed drawings. The disclosure includes all such modifications and alterations and is limited only by the scope of the following claims. In particular regard to the various functions performed by the above described components (e.g., elements, resources, etc.), the terms used to describe such components are intended to correspond, unless otherwise indicated, to any component which performs the specified function of the described component (e.g., that is functionally equivalent), even though not structurally equivalent to the disclosed structure. In addition, while a particular feature of the disclosure may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application.2024-043-02 31

Claims

CLAIMSWhat is claimed is:1 . An aortic root repair system, comprising: a first structure comprising: a first tube; a ring extending circumferentially along the first tube and configured to be coupled to ventricular tissue of a patient; and a first plurality of protrusions, extending from the first tube, comprising: a first protrusion configured to be coupled to first aortal tissue of an aorta of the patient; and a second protrusion configured to be coupled to second aortal tissue of the aorta; and a second structure comprising: a second tube; and a second plurality of protrusions, extending from a first side of the second tube, comprising a third protrusion configured to be coupled to the first protrusion and the second protrusion.

2. The aortic root repair system of claim 1 , wherein: a second side of the second tube is configured to be coupled to an ascending aorta of the patient.

3. The aortic root repair system of claim 1 , comprising: a graft, coupled to a second side of the second tube, configured to be coupled to an ascending aorta of the patient.

4. The aortic root repair system of claim 1 , comprising: a first magnet in the first protrusion; and a second magnet in the second structure, wherein the first magnet is configured to interact with the second magnet to align the first structure with the second structure.2024-043-02 325. The aortic root repair system of claim 1 , wherein: the first structure comprises one or more interlocking features, extending from the first tube, configured to engage the second structure.

6. The aortic root repair system of claim 1 , wherein: the ring comprises a coil.

7. The aortic root repair system of claim 1 , wherein: the first plurality of protrusions comprise three protrusions; and the second plurality of protrusions comprise three protrusions.

8. The aortic root repair system of claim 1 , wherein: the first plurality of protrusions comprise two protrusions; and the second plurality of protrusions comprise two protrusions.

9. The aortic root repair system of claim 1 , wherein: a first space is defined by the first structure between the first protrusion and the second protrusion; and the third protrusion occupies the first space when the third protrusion is coupled to the first protrusion and the second protrusion.

10. The aortic root repair system of claim 1 , wherein: the third protrusion comprises an edge configured to mate with at least one of an edge of the first protrusion or an edge of the second protrusion.

11. A method for valve sparing root replacement comprising: coupling a ring of a first structure to ventricular tissue of a patient; coupling a first protrusion of the first structure to first aortal tissue of an aorta of the patient; coupling a second protrusion of the first structure to second aortal tissue of the aorta; coupling a second structure to the first structure; coupling a left coronary artery to the second structure; and coupling a right coronary artery to the second structure.2024-043-02 3312. The method of claim 11 , comprising: coupling the second structure to an ascending aorta of the patient.

13. The method of claim 11 , comprising: coupling a first side of a graft to the second structure; and coupling a second side of the graft to an ascending aorta of the patient.

14. The method of claim 11 , comprising: positioning the second structure in a target position relative to the first structure using a first magnet in the first protrusion and a second magnet in the second structure.

15. The method of claim 11 , wherein coupling the second structure to the first structure is performed in response to positioning the second structure in the target position.

16. The method of claim 11 , wherein coupling the second structure to the first structure comprises: coupling a third protrusion, of the second structure, to the first protrusion, the second protrusion, and a region, of the first structure, between the first protrusion and the second protrusion.

17. The method of claim 11 , comprising: forming a first opening in a third protrusion of the second structure, wherein coupling the left coronary artery to the second structure comprises coupling a left coronary button to a boundary of the first opening; and forming a second opening in a fourth protrusion of the second structure, wherein coupling the right coronary artery to the second structure comprises coupling a right coronary button to a boundary of the second opening.

18. The method of claim 11 , wherein coupling the ring of the first structure to the ventricular tissue of the patient comprises:2024-043-02 34suturing the ring of the first structure to the ventricular tissue.

19. The method of claim 11 , wherein coupling the first protrusion of the first structure to the first aortal tissue of the aorta of the patient comprises: suturing the first protrusion of the first structure to the first aortal tissue.

20. The method of claim 11 , wherein coupling the second protrusion of the first structure to the second aortal tissue of the aorta comprises: suturing the second protrusion of the first structure to the second aortal tissue.21 . The method of claim 11 , wherein coupling the second structure to the first structure comprises: suturing the second structure to the first structure.

22. A method for a Ross procedure comprising: coupling sutures to a left ventricular outflow tract of a patient; coupling an autograft valve to at least one of an aortic annulus or the left ventricular outflow tract; coupling the sutures to a ring of a first structure; coupling a first protrusion of the first structure to a first commissure of the autograft valve; coupling a second protrusion of the first structure to a second commissure of the autograft valve; coupling the autograft valve to a first side of a tube; coupling a left coronary artery to a first sinus of the autograft valve; coupling a right coronary artery to a second sinus of the autograft valve; and coupling a second side of the tube to an ascending aorta.

23. The method of claim 22, comprising: performing pulmonary homograft reconstruction.2024-043-02 3524. The method of claim 22, wherein coupling the first protrusion of the first structure to the first commissure of the autograft valve comprises: suturing the first protrusion of the first structure to the first commissure of the autograft valve.

25. The method of claim 22, wherein coupling the second protrusion of the first structure to the second commissure of the autograft valve comprises: suturing the second protrusion of the first structure to the second commissure of the autograft valve.

26. The method of claim 22, wherein coupling the autograft valve to the first side of the tube comprises: suturing the autograft valve to the first side of the tube.

26. The method of claim 22, wherein coupling the second side of the tube to the ascending aorta comprises: suturing the second side of the tube to the ascending aorta.

27. A method, comprising: at least one aspect as described in any one of the preceding claims.2024-043-02 36

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