Dual guidewire system for calcified valves

Abstract

Methods and devices are described for advancing a guidewire through the calcified leaflets of a heart valve. The dual guidewire device includes a primary guidewire, a secondary guidewire, and a sheath. The primary guidewire is configured to advance through the heart valve and the secondary guidewire is configured to pull open the calcified leaflets of the heart valve while the primary guidewire is advanced through the heart valve. A catheter may include both the primary and secondary guidewires.

Description

Technical Field

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 164,438, filed on March 22, 2021, entitled "DUAL GUIDEWIRE SYSTEM FOR CALCIFIED VALVES", the entire disclosure of which is hereby incorporated by reference in its entirety.

[0002] Background Field The present disclosure generally relates to the field of cardiac implant devices and implant technologies.

Background Art

[0003] Description of Related Technologies Cardiac valve dysfunction, such as valve calcification, can complicate the operation of implanting a medical device or can be performed other operations within the heart. Valvular stenosis occurs when the heart valve narrows. This stenosis prevents the valve from opening fully, which reduces or blocks blood flow. When blood flow through the valve is reduced or blocked, the heart has to work harder to pump blood. Eventually, this extra work limits the amount of blood that can be pumped, which can cause symptoms and can even weaken the myocardium.

Summary of the Invention

[0004] Summary This specification describes one or more methods and / or devices for facilitating the implantation of a device through a calcified or otherwise narrowed heart valve using at least two guidewires.

[0005] One common embodiment includes a device for advancing a primary guidewire through a heart valve. The device includes a primary guidewire configured to advance through the heart valve. The device also includes a secondary guidewire configured to pull and open the leaflets of the heart valve while the primary guidewire advances through the valve. The primary guidewire may be operable independently of the secondary guidewire. The device may also include a catheter that houses both the primary and secondary guidewires.

[0006] The implementation of the device may include one or more of the following features: The secondary guidewire may include a leaflet anchor configured to be removably coupled to the leaflets of a heart valve. In embodiments, the leaflet anchor may include a needle configured to penetrate the proximal surface of the leaflet and a hook configured to be attached to the distal surface of the leaflet, the distal surface being opposite to the proximal surface.

[0007] In one embodiment, the leaflet anchor may include a suction cup configured to bond with the proximal surface of the leaflet. In one embodiment, the leaflet anchor may include a thread. In some embodiments, the leaflet anchor may include a conical or pyramidal shape having a pointed end and a base surface opposite the pointed end, wherein the pointed end is configured to penetrate the proximal surface of the leaflet and the base surface is configured to abut against the distal surface of the leaflet.

[0008] In one implementation, the valve leaflet anchor may include a first prong and a second prong that are operable in a first configuration and a second configuration, in which the first prong is substantially parallel to the second prong, and in which the first prong is substantially perpendicular to the second prong.

[0009] The apparatus may include a sheath configured to hold a first prong in a first configuration together with a second prong in response to the sheath being in a first position. The sheath may also be configured to release the first prong into a second configuration in response to the sheath being in a second position, the second position being reached by pulling the sheath away from the distal end of the valve leaflet anchor. In one embodiment, the first prong is configured to bend at a right angle in the second configuration.

[0010] In one embodiment, the valve leaflet anchor may include a first prong operable in a first configuration and a second configuration, a second prong, and a joint connecting the first and second prongs at a point away from the distal ends of the first and second prongs. In the first configuration, the first prong is pressed against the second prong, and in the second configuration, the first prong is separated from the second prong. In the first configuration, the first and second prongs may be configured to hold a portion of the valve leaflet between them. The device may include a sheath configured to press the first prong against the second prong in the first configuration.

[0011] One general embodiment includes a method for advancing a primary guidewire through a calcified valve leaflet. The method may include the step of advancing a catheter configured to surround the primary and secondary guidewires. The method may also include the step of attaching the leaflet anchor of the secondary guidewire to the calcified valve leaflet of the valve. The method may also include the step of retracting the secondary guidewire attached to the calcified valve leaflet in order to open the valve. The method may further include the step of advancing the primary guidewire through the opened valve.

[0012] The method may include one or more of the following features: The method may include the steps of removing a secondary guidewire from the calcified valve leaflet and performing a medical procedure using a primary guidewire. For example, the medical procedure may be a transcatheter aortic valve replacement. The step of retracting the secondary guidewire may include the step of retracting the secondary guidewire through the first lumen of the catheter, and the step of advancing the primary guidewire may include the step of advancing the primary guidewire through the second lumen of the catheter.

[0013] Another common embodiment includes a guidewire configured to be removably attached to the valve leaflet via a leaflet anchor. The guidewire may include a first prong that is operable to a closed configuration and an open configuration. The guidewire may also include a second prong. The guidewire may also include a sheath configured to move from a first position that compresses the first prong relative to the second prong to form a closed configuration to a second position that releases the first prong from the second prong to form an open configuration. In the open configuration, the first prong is separated from the second prong and may form a hook, and in the closed configuration, the first prong may together with the second prong form a needle.

[0014] The implementation of the guidewire may include one or more of the following features: When the leaflet anchor is inserted through the proximal surface of the calcified leaflet, the leaflet anchor may be in a closed configuration. When the leaflet anchor is hooked onto the distal surface of the calcified leaflet, the leaflet anchor may be in an open configuration.

[0015] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the invention. In addition, various features of different disclosed embodiments may be combined to form additional embodiments which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondences between reference elements. [Brief explanation of the drawing]

[0016] [Figure 1] Figure 1 provides a cross-sectional view of a human heart. [Figure 2] Figure 2 provides a cross-sectional view of the left ventricle and left atrium of an exemplary heart. [Figure 3] Figures 3A and 3B show external perspective views of a dual guidewire device positioned within the aortic valve according to a specific embodiment. [Figure 4A] Figure 4A shows a double guidewire device with a hook device for valve leaflet anchors according to a specific embodiment. [Figure 4B] Figure 4B shows a double guidewire device with a hook device for valve leaflet anchors according to a specific embodiment. [Figure 5A] Figure 5A shows a dual guidewire device with a suction device for valve leaflet anchors according to a specific embodiment. [Figure 5B] Figure 5B shows a dual guidewire device with a suction device for valve leaflet anchors according to a specific embodiment. [Figure 6A] Figure 6A shows a secondary guidewire with an operable valve leaflet anchor and sheath according to a specific embodiment. [Figure 6B] Figure 6B shows a secondary guidewire with an operable valve leaflet anchor and sheath according to a specific embodiment. [Figure 6C] Figure 6C shows a secondary guidewire with an operable valve leaflet anchor and sheath according to a specific embodiment. [Figure 7] Figure 7 provides a flowchart illustrating the process for performing a medical procedure using a dual guidewire device 100 according to a specific embodiment. [Modes for carrying out the invention]

[0017] Detailed explanation While specific preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of the claims arising from this specification is not limited by any of the specific embodiments described below. For example, in connection with any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any specific disclosed order.

[0018] The various operations may be described sequentially as a plurality of discrete operations in a manner that may be useful for understanding certain embodiments, but the order of the description should not be construed as implying that these operations are order-dependent. Additionally, the structures, systems, and / or apparatus / devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Further, the headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0019] Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, the various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may be similarly taught or suggested herein. Like reference numerals may be used with respect to separate figures and / or embodiments, and the use of such like or identical reference numerals should not necessarily be construed as identifying the same components, but may refer to distinct features.

[0020] Overview One cause of valve stenosis is the accumulation of calcium deposits on the heart valves (valve calcification). Calcium is a mineral present in the blood. As blood repeatedly flows over the valves, calcium deposits can accumulate on the valve cusp. These deposits may not cause any problems. However, in some people, especially those with congenitally abnormal valves, calcium deposits can lead to hardening of the valve cusp. This hardening narrows the valve. In calcified valves, the passage of a guidewire through the valve can require considerable time and expertise, as it typically needs to advance through a small opening created by calcification relative to the blood flow.

[0021] The following disclosure describes a dual guidewire system for guiding catheter insertion, wherein a primary guidewire is configured to guide the catheter to a target site in the heart, and a secondary guidewire is configured to fix itself to the leaflet of a calcified heart valve and to hold the valve opening open for the primary guidewire or to otherwise expand it. The secondary guidewire may include a leaflet anchor for removable attachment to the leaflet. In one embodiment, the leaflet anchor includes a sharp needle with a hook, the needle configured to penetrate the proximal side of the leaflet, and the hook configured to attach to the distal side of the leaflet. Other embodiments of the attachment mechanism for the leaflet anchor may include adhesives, clamping arms, suction cups, and / or similar.

[0022] Transplant location In humans and other vertebrates, the heart is a muscular organ that generally has four pumping chambers, and its flow is at least partially controlled by various heart valves, namely the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. The valves may be configured to open and close in response to pressure gradients present during different stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to the respective regions of the heart and / or blood vessels (e.g., lungs, aorta, etc.).

[0023] Figure 1 shows an exemplary representation of a heart 1 having various features relating to a particular embodiment of the disclosure of the present invention. The heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A muscular wall 17, referred to as the septum, separates the left atrium 2 and the right atrium 5, as well as the left ventricle 3 and the right ventricle 4. The heart 1 further comprises four valves to assist blood circulation within it, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may generally have three cusps or leaflets and may generally be closed during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The valves of the heart 1 may further comprise a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 13 and may be configured to open during systole so that blood can be pumped toward the lungs and to close during diastole to prevent blood from flowing backward from the pulmonary artery into the heart. The pulmonary valve 9 generally has three cusps / leaflets, each of which may have a crescent shape. The heart 1 further includes the mitral valve 6, which generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 may generally be configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3 and to close during diastole to favorably prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to flow out of the left ventricle 3 into the aorta 12 and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0024] A heart valve may generally consist of a relatively dense fibrous ring, referred to herein as the annulus, and several leaflets or cusps attached to the annulus. Generally, the size and position of the leaflets or cusps may be such that, when the heart contracts, the resulting increase in blood pressure generated in the corresponding chamber forces the leaflets to open at least partially, allowing flow from the chamber. When the pressure in the chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant, pushing back towards the leaflets. As a result, the leaflets / cusps are juxtaposed with each other so that the leaflets / cusps align, thereby closing the flow path.

[0025] The atrioventricular heart valves (i.e., the mitral valve 6 and the tricuspid valve 8) may further include groups of chordae tendineae (16, 11) and papillary muscles (15, 10) for fixing the leaflets of each valve in order to promote and / or facilitate proper fusion of the leaflets and prevent their prolapse. The papillary muscles (15, 10) may generally include finger-like projections from the ventricular wall, while the chordae tendineae (16, 11) may include cord-like tendons connecting the papillary muscles to the leaflets.

[0026] Regarding the mitral valve 6, a normal mitral valve may comprise two leaflets (anterior and posterior) and chordae tendineae 16 connecting the leaflets to two corresponding papillary muscles 15. The papillary muscles 15 protrude into the left ventricle 3, originating from the left ventricular wall. The leaflets of the mitral valve 6 can be prevented from protruding into the left atrium 2 by the action of the tendons of the chordae tendineae 16 that connect the leaflets to the papillary muscles 15. The relatively inelastic chordae tendineae 16 are attached to the papillary muscles 15 at one end and to the leaflets at the other, with the chordae tendineae from each papillary muscle 15 attaching to the respective leaflets of the mitral valve 6. Therefore, when the left ventricle 3 contracts, the intraventricular pressure can force the valve to close, while the chordae tendineae 16 can keep the leaflets joined together, preventing the valve from opening in the wrong direction, thereby preventing blood from flowing into and returning to the left atrium 2. The various cords of the chordae tendineae can have different thicknesses; the relatively thinner cords are attached to the periphery of the freely moving valve leaflets, while the relatively thicker cords (e.g., the support cords) are attached further away from the freely moving periphery.

[0027] With respect to the tricuspid valve 8, a normal tricuspid valve may comprise three leaflets (two shown in Figure 1) and three corresponding papillary muscles 10 (two shown in Figure 1). The leaflets of the tricuspid valve 8 may be called the anterior leaflet, posterior leaflet, and septal leaflet, respectively. The leaflets are connected to the papillary muscles by chordae tendineae 11, which are located in the right ventricle 4 together with the papillary muscles 10. Although the tricuspid valve is described herein as comprising three leaflets, it should be understood that the tricuspid valve may be found with two or four leaflets in certain patients and / or conditions. The principles relating to the connection and / or coordination of the papillary muscles disclosed herein are applicable to atrioventricular valves having any number of leaflets and / or chordae tendineae or papillary muscles associated therewith. The papillary muscles 10 of the right ventricle attach to the anterior leaflet, posterior leaflet, and septal leaflet of the tricuspid valve via chordae tendineae 11, starting from the right ventricular wall. The papillary muscles 10 may play a role in fixing the leaflets of the tricuspid valve 8, preventing them from protruding into the right atrium 5 during ventricular systole. Tricuspid regurgitation may result from papillary dysfunction or chordal rupture.

[0028] Heart valve disease refers to a condition in which one or more of the heart valves do not function properly. Affected heart valves can be classified as stenotic, meaning the valve does not open sufficiently to allow proper forward flow of blood through the valve, and / or dysfunctional, meaning the valve does not close completely, causing excessive regurgitation of blood when the valve is closed. In certain conditions, valvular disease can be severely debilitating and, if left untreated, can even be fatal. With regard to dysfunctional heart valves, due to the passage of time and / or various physiological conditions, the position and / or tension of the chordae tendineae and / or papillary muscles may change, thereby pulling on the valve leaflets and causing them to open at least partially, which can lead to valve regurgitation. For example, functional mitral regurgitation can occur when the left ventricle of the heart becomes distorted or dilated, displacing the papillary muscles (and the chordae tendineae attached to them) that support the mitral valve leaflets. For example, the valve leaflets may no longer close together to form the annulus, resulting in blood flowing back into the atria. If left untreated, functional mitral regurgitation can overload the heart and lead to or accelerate heart failure. Moving or pulling the chordae tendineae closer to the flow axis of the annulus, according to their natural healthy position, can potentially reduce the occurrence of valve regurgitation.

[0029] Several types of valvular disease result in leaflet calcification, which can complicate procedures that access the heart through the valve. Mitral annular calcification, characterized by calcium and lipid deposition in the annular fibers of the mitral valve, is a degenerative process that commonly occurs in older adults. Patients with mitral annular calcification may also have mitral leaflet calcification. In contrast to the mitral valve, calcification involving the tricuspid valve is rare. Isolated cases of tricuspid valve calcification have been reported to be associated with rheumatic heart disease, bacterial endocarditis, ventricular septal defects, and congenital malformations of the tricuspid valve.

[0030] On the other hand, calcified aortic valve stenosis is widely recognized and a relatively common clinical and pathological entity. Aortic valve calcification is a condition in which calcium deposits form on the aortic valve of the heart. These deposits can cause narrowing of the aortic valve opening. This narrowing can become severe enough to reduce blood flow through the aortic valve. In contrast, calcified pulmonary artery stenosis is rarely encountered, either surgically or at autopsy. Some physicians have observed small calcium deposits on one or more pulmonary valve leaflets in adult-aged patients with left-to-right arteriovenous fistulas, and in older individuals with severe pulmonary hypertension secondary to lung disease.

[0031] The various solutions disclosed herein relate to devices and methods for accessing the heart through calcified valve leaflets using a dual guidewire system. Such devices and methods can be used during procedures including transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI). Valve replacement typically requires an open-heart procedure via a "sternotomy," where the chest is surgically separated (opened) for the procedure. TAVR or TAVI procedures can be performed through a very small opening, leaving all the sternal bones in place. For example, TAVR procedures are performed using one of two approaches: a transfemoral approach through the femoral artery (aorta in the groin) (which does not require a surgical incision in the chest), or a minimally invasive surgical approach with a small incision in the chest, through the thoracic aorta, or a transapical approach through the tip of the left ventricle (apex).

[0032] Dual guidewire device As referenced above, certain embodiments disclosed herein provide systems, apparatus, and methods for advancing a primary guidewire through a calcified valve leaflet while a secondary guidewire enlarges the valve opening by pulling the calcified valve leaflet. Such apparatus may be introduced into a patient system via surgical means or, advantageously, minimally invasive means.

[0033] A guidewire is a wire or spring typically used as a guide for positioning larger devices or prostheses, such as catheters or replacement valves. Guidewires are designed to travel through blood vessels and reach their target destination. Once the tip of the device reaches its destination, it acts as a guide, allowing a larger catheter to quickly follow for easier delivery to the treatment site. Guidewires can vary in tip size, length, stiffness, composition, and shape.

[0034] Generally, a guidewire consists of four main components: the core, the wire tip, the body, and the coating. The inner portion of the wire is called the core. Typically, the core is made of either highly flexible nitinol or hard stainless steel, which indicates the flexibility of the guidewire. The tip refers to the distal end of the wire. The end of the wire tip is often wrapped with a ribbon of flexible metal to make the tip more flexible and less traumatic. The body of the wire surrounding the core is typically made of coil or polymer. Generally, the body of the wire (e.g., spring coil or polymer cover) is covered with an overlay, i.e., a specific material that gives the wire the ability to reduce surface friction and improve device interaction and guidewire tracking. Depending on the intended use, the coating may be hydrophilic, hydrophobic, or have some other properties to aid insertion.

[0035] Figures 3 to 7 may illustrate medical implants and / or processes that include features for advancing a primary guidewire through calcified valve leaflets using a secondary guidewire, although these features may be used independently or in combination with each other. For example, a dual guidewire device may use various types of leaflet anchors, as shown in Figures 4A to 6C. Various embodiments of a dual guidewire device utilizing different leaflet anchors may use the process shown in Figure 7.

[0036] Figures 3A and 3B show external perspective views of a dual guidewire device 100 positioned within the aortic valve 7 according to a particular embodiment. The dual guidewire device 100 may comprise a primary guidewire 105, a secondary guidewire 110, and a catheter (not shown) for housing the primary and secondary guidewires and facilitating the movement of the device through the body. The secondary guidewire 110 may include a leaflet anchor 115 for attachment to the leaflets 120 of the aortic valve. Various structures can be used as leaflet anchors. For example, the leaflet anchor may be configured to penetrate the leaflet and be fixed to the other side (distal surface). In other embodiments, the leaflet anchor is configured to be attached to the side facing the leaflet (proximal surface).

[0037] In one embodiment, the leaflet anchor has a pointed shape with a wider base (e.g., cone, pyramidal, etc.), as shown in Figures 3A and 3B, and the pointed end can penetrate the proximal surface of the leaflet. As shown in Figure 3A, after the leaflet anchor 115 has passed the leaflet 120, the distal surface of the base opposite the pointed end can come into contact with the distal surface of the leaflet.

[0038] As shown in Figure 3B, the secondary guidewire 110 can be pulled along with the attached valve leaflets 120 to enlarge the valve opening. In the case of calcification, the valve leaflets typically do not have enough flexibility to open completely, providing a smaller opening for the primary guidewire 105 to pass through. To mitigate this, the secondary guidewire 110 can be pulled manually or using a pulling mechanism (e.g., a reel, winch, etc.) built into the handle of the device that can widen the opening of the aortic valve 7. The distal end 125 of the primary guidewire can then be advanced through the aortic valve 7.

[0039] Figures 4A and 4B show a double guidewire device 100 having a hook device 415 for valve leaflet anchors according to a particular embodiment. Figure 4B shows an enlarged view of the guidewire device 100 of Figure 4A. The hook device 415 may include a hook 420 and a needle 425. In an exemplary configuration, the end of the needle 425 forms the farthest distal point of the hook device. The hook 420, on the other hand, is formed proximal to the needle 425, with the interior of the arc formed by the hook 420 facing proximal, and the exterior of the arc formed by the hook 420 facing distal to the shaft of the secondary guidewire 110. In some embodiments, the needle 425 is straight with respect to the shaft of the secondary guidewire. However, in some embodiments, the needle 425 may be inclined or curved toward the outer arc of the hook 420. By bending the end of the needle 425 closer to the hook 420, the contact point between the hook device 415 and the valve leaflet (the tip of the needle and the upper part of the outer arc) can be narrowed, thereby reducing the size of the tear created within the valve leaflet when the hook device 415 is pushed through.

[0040] In an exemplary operation, the needle 425 penetrates the valve leaflet 120 from the proximal surface 122 (towards the inlet point of the guidewire device 100), creating an inlet point through which the hook 420 can pass. The hook 420 can then engage with the distal surface 124 of the valve leaflet 120 (away from the inlet point of the guidewire device 100).

[0041] Figures 5A and 5B show a double guidewire device 100 having a suction device 515 for valve leaflet anchoring according to a particular embodiment. Figure 5B shows an enlarged view of the guidewire device 100 of Figure 5A. The suction device 515 can be attached to the proximal surface 122 of the valve leaflet 120. The suction device 515 comprises a cup formed of a flexible material. When pressed against the valve leaflet, the cup is compressed, discharging the fluid within it. As the cup attempts to reshape itself back to its original form, the rim of the cup is pressed against the valve leaflet, forming a seal. With the cup sealed, a vacuum is formed inside, attaching the valve leaflet to the cup.

[0042] Since the suction device 515 is attached to the proximal surface 122, penetration is not required, and damage to the valve leaflets 120 may be less. Some operations may be for implanting an artificial valve, while others may leave the existing valve in place. In these situations, it may be beneficial to limit damage to the valve leaflets to facilitate repair. Other embodiments of the dual guidewire device 100 may function similarly by being attached to the proximal surface, but alternative embodiments of leaflet anchors, such as screw devices or adhesives, may be used for attachment to the valve leaflets 120.

[0043] Figures 6A to 6C illustrate a secondary guidewire 110 having an actuated leaflet anchor 605 and a sheath 610. In the illustrated embodiments, the actuated leaflet anchor comprises two prongs 615, 620. The first prong 615 can be biased such that its end 616 bends to a position substantially horizontal with respect to its shaft 618, forming a hook. For example, the prong material (e.g., spring steel) may be flexible but will spring back to its original bent shape. The bent shape may form a right angle, but may differ by only a few degrees, as long as the first prong can still hook onto the leaflet. In some embodiments, the movement of the sheath 610 on the actuated leaflet anchor 605 modifies the configuration of the actuated leaflet anchor, as will be discussed further below.

[0044] In the first configuration shown in Figure 6A, the end of the sheath 610 is in a first position 625 relative to the operable valve leaflet anchor 605, preventing the biasing prong 615 from moving to a horizontal position. Instead, the biasing prong 615 and the second prong 620 are pushed together by the sheath to form a needle. Both prongs may taper to a certain point so that the joined prongs together form a needle, as shown in Figure 6A. In the first configuration, the needle formed by the operable valve leaflet anchor 605 allows the operable valve leaflet anchor 605 to penetrate the valve leaflet more easily.

[0045] In the second configuration shown in Figure 6B, the end of the sheath 610 moves to a second position 630 located distal to the first position 625, thereby exposing more of the structure of the operable valve leaflet anchor 605. The movement from the first position 625 to the second position 630 may be achieved manually, for example, by the user pulling the sheath, or by a mechanism. By pulling the sheath to the second position 630, the biasing prong 615 is disengaged by the sheath 610, allowing the biasing prong 615 to bend and form a hook structure.

[0046] In one exemplary use case, after pushing the secondary guidewire 110 through the valve leaflet while in the first configuration, the user can pull the sheath 610 to the second position 630. The actuated valve leaflet anchor 605 then changes from the first configuration to the second configuration. With the biasing prong 615 in the horizontal position, the biasing prong 615 contacts the distal surface of the valve leaflet, thereby increasing the surface area in contact with the valve leaflet. This allows a greater force to be applied to the valve leaflet before the actuated valve leaflet anchor 605 damages the valve leaflet, increasing the likelihood that the secondary guidewire 110 can pull the valve leaflet open and position the valve opening to expand to the desired degree.

[0047] As described above, the operable valve leaflet anchor 605 can be manufactured in various forms, such as a needle, anchor, adhesive, or a pointed structure with a broad base. In addition, various types of materials, such as nitinol, stainless steel, or other biocompatible materials, can be used for the valve leaflet anchor and guidewire.

[0048] In the above description, an operable leaflet anchor 605 was used to penetrate the leaflet 120 and attach to the distal surface 124 (shown in Figure 4B). However, the operable leaflet anchor 605 may also be used to attach to the proximal surface of the leaflet by sandwiching the leaflet between two prongs 615, 620. In the open configuration shown in Figure 6B, the sheath 610 is in the second position 630, the operable leaflet anchor 605 is open, and the first prong 615 and the second prong 620 are separated from each other. The operable leaflet anchor 605 can be advanced toward the leaflet until the second prong 620 is pushed into the leaflet. The sheath 610 then moves to the first position 625, as shown in the closed configuration in Figure 6A, thereby pushing the first prong 615 and the second prong 620 together. With prongs 615 and 620 in the closed position, a portion of the valve leaflet is sandwiched between the two prongs, and the movable valve leaflet anchor 605 is attached to the valve leaflet. The valve can then be opened by pulling the movable valve leaflet anchor 605.

[0049] In the alternative use described above, the operable leaflet anchor 605 may be adapted to better grip the leaflet. For example, the first prong 615 and the second prong 620 may have wider and flatter ends to increase the contact surface area for gripping the leaflet tissue. In another embodiment, the first prong 615 and the second prong 620 may be attached together by a joint below the ends of the prongs, similar to pliers and scissors, to better facilitate the gripping action by the two prongs. A spring or other biasing material may be located near the joint to push the two prongs open, unless held together by the sheath 610. In that implementation, the sheath 610 can be used to close the prongs together by advancing distally and to release the prongs by retracting proximally.

[0050] Use of guide wires Figure 7 provides a flowchart illustrating the process for performing a medical procedure using a dual guidewire device 100 according to one or more embodiments disclosed herein. Medical professionals, such as surgeons, can use the process during transseptal, transaortic, transfemoral, transradial, transapical, or other surgical approaches to perform medical procedures requiring access through a heart valve (e.g., placement of a stent, valve, or other implant). For ease of explanation, the transfemoral approach to the aortic valve, such as that used during TAVR procedures, is described below. However, the process may be performed using other approaches and / or targeting other heart valves. Furthermore, for ease of explanation, label numbers from previous figures are used below. However, the process is not limited to the specific embodiments illustrated in these figures.

[0051] In block 705, the medical professional gains access to the femoral artery from the insertion site on the patient's body. The medical professional can insert the catheter at the insertion site and into the femoral artery. In some embodiments, the catheter may have separate lumens for the primary guidewire 105 and the secondary guidewire 110. In other embodiments, a single lumen may be used, and the guidewires may share a lumen. In some embodiments, three or more guidewires may be used, each with a separate lumen.

[0052] In block 710, the medical professional inserts the dual guidewire device 100 into the aorta and aortic arch to approach the aortic valve. In some embodiments, one or more guidewires may already be present in the catheter while it is being inserted into the patient's body. In other embodiments, the catheter is empty, and the guidewires are inserted after the catheter has reached a target site in the body (e.g., the aortic valve).

[0053] In block 715, the medical professional attaches the secondary guidewire to the aortic valve leaflet. As mentioned above, various types of leaflet anchors, from mechanical to adhesive, can be used to attach to the calcified leaflet.

[0054] In some embodiments, the secondary guidewire may be attached to the proximal surface of the valve leaflet. For example, the secondary guidewire may be attached to the surface using a suction cup or adhesive. In one embodiment, the valve leaflet anchor is a screw that is screwed into the valve leaflet, for example, by rotating the guidewire to drive the screw into the valve leaflet tissue. In another embodiment, the valve leaflet anchor includes a pair of jaws or prongs that pivot on a joint, similar to pliers, to grip the valve leaflet between the jaws or prongs.

[0055] In other embodiments, the secondary guidewire may penetrate the valve leaflet and be pressed against the distal surface of the leaflet. For example, the leaflet anchor may be a needle-and-hook structure, a tapered conical or pyramidal structure, or part of an embodiment shown in the aforementioned figures.

[0056] In block 720, the medical professional opens the aortic valve by retracting the valve leaflets with a secondary guidewire. In some embodiments, the dual guidewire device may have a winch, reel, or other mechanism for pulling the guidewire, attached to the end of the guidewire outside the patient's body. In some embodiments, the medical professional may manually pull the secondary guidewire.

[0057] In block 725, the secondary guidewire pulls the calcified valve leaflet, widening the valve opening and allowing the primary guidewire to push through the widened opening. In some embodiments, multiple guidewires can be used and attached to multiple valve leaflets. For example, if a single guidewire pulling a single valve leaflet sufficiently widens the opening, a second guidewire can be attached to the second valve leaflet to open the valve further. Even a third guidewire may be used to attach to a third valve leaflet (for example, when opening a tricuspid valve).

[0058] In block 730, the secondary guidewire can be removed from the valve leaflet. For example, for a leaflet anchor that penetrates the leaflet and abuts against the distal surface of the leaflet, the cover sheath may be moved over the leaflet anchor, allowing the leaflet anchor to be pulled back through the leaflet. For a leaflet anchor attached to the proximal surface of the leaflet, the leaflet anchor can be removed using various removal methods. For example, a screw anchor can be loosened, a jaw anchor can be opened to release the leaflet, and a suction cup can be lifted to release the vacuum seal. In some embodiments, adhesive anchors may use an adhesive formulated to dissolve after a certain amount of time, thereby releasing the leaflet. Once removed, the secondary guidewire can be withdrawn from the catheter and withdrawn from the patient's body.

[0059] In block 735, the primary guidewire can then be guided to its destination within the heart, where it can be used in performing various possible medical procedures, such as TAVR procedures, other procedures for device implantation, or other procedures for operation on the heart.

[0060] Additional Embodiments Depending on the embodiment, any particular action, event, or function of the process described herein may be performed in a different order, added, merged, or completely excluded. Therefore, in a particular embodiment, not all described actions or events are necessary for the practice of the process. Furthermore, in a particular embodiment, the actions or events may be performed simultaneously rather than sequentially.

[0061] In particular, conditional language used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” is intended in its ordinary sense unless otherwise stated or understood differently in the context in which it is used, and is generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in other embodiments. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these features, elements, and / or steps are included or performed in any particular embodiment. Terms such as “comprising,” “including,” and “having” are synonymous and are used in their ordinary sense, comprehensively and non-restrictively, without precluding additional elements, features, actions, functions, etc. Furthermore, the term “or” is used in its inclusive sense (and not its exclusive sense), for example, when used to connect a list of elements, so that the term “or” means one, some, or all of the elements in the list. Unless otherwise specified, connecting phrases such as “at least one of X, Y, and Z” are understood in context to be used to generally convey that an item, term, element, etc., could be any of X, Y, or Z. Thus, such connecting phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, each of which is relevant.

[0062] It should be understood that certain sequential terms (e.g., “first” or “second,” “primary” or “secondary”) may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, when used herein, sequential terms used to modify elements such as structures, components, and actions (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of the element relative to any other element, but rather generally distinguish the element from other elements having similar or identical names (other than the use of sequential terms). In addition, when used herein, the indefinite articles ("a" and "an") may indicate “one or more” rather than “one.” Furthermore, actions performed “based on” a condition or event may also be performed based on one or more other conditions or events not expressly stated.

[0063] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0064] The spatially relative terms “outside,” “inside,” “top,” “bottom,” “downward,” “upward,” “vertical,” “horizontal,” “proximal,” “distal,” and similar terms may be used herein to facilitate explanation and to describe the relationship between one element or component and another, as shown in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, if the device shown in the drawings is turned over, a device positioned “below” or “directly below” another device may be positioned “above” the other device. Thus, the exemplary term “downward” may include both lower and upper positions. The device may also be oriented in other directions, and therefore, the spatially relative terms may have different interpretations depending on the orientation.

[0065] Unless otherwise explicitly stated, comparative and / or quantitative terms such as "less," "more," and "greater" are intended to encompass the concept of equality. For example, "less" can mean not only "less" in the strict mathematical sense, but also "less than or equal to."

[0066] In the above description of embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than expressly described in that claim. Furthermore, any component, feature, or step illustrated and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is required or essential to each embodiment. Accordingly, the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, and should be determined solely by a fair reading of the following claims. [Explanation of symbols]

[0067] 100 Double guidewire device, 105 Primary guidewire, 110 Secondary guidewire, 115, 605 Leaflet anchor, 122 Proximal surface, 124 Distal surface, 415 Hook device, 420 Hook, 425 Needle, 515 Suction device, 610 Sheath, 615 First prong, 620 Second prong

Claims

1. A device for advancing a primary guidewire through a heart valve, wherein the device is A primary guidewire configured to pass through the heart valve and advance, A secondary guidewire is configured to pull and open the valve leaflets of the heart valve while the primary guidewire advances through the heart valve, A device comprising a catheter that accommodates both the primary guidewire and the secondary guidewire.

2. The apparatus according to claim 1, further comprising a leaflet anchor configured to be removably coupled to the leaflet of the heart valve, the secondary guidewire.

3. The apparatus according to claim 2, wherein the valve leaflet anchor comprises a needle configured to penetrate the proximal surface of the valve leaflet and a hook configured to be attached to the distal surface of the valve leaflet, the distal surface being on the opposite side of the proximal surface.

4. The apparatus according to claim 2, wherein the valve leaflet anchor comprises a suction cup configured to bond with the proximal surface of the valve leaflet.

5. The apparatus according to claim 2, wherein the valve leaflet anchor is threaded.

6. The apparatus according to claim 2, wherein the valve leaflet anchor includes a conical or pyramidal shape having a pointed end and a base surface opposite to the pointed end, wherein the pointed end is configured to penetrate the proximal surface of the valve leaflet and the base surface is configured to abut against the distal surface of the valve leaflet.

7. The apparatus according to claim 2, wherein the valve leaflet anchor comprises a first prong and a second prong operable in a first configuration and a second configuration, wherein in the first configuration the first prong is substantially parallel to the second prong and in the second configuration the first prong is substantially perpendicular to the second prong.

8. The apparatus according to claim 7, further comprising a sheath configured to hold the first prongs together with the second prongs in the first configuration in response to the sheath being in a first position.

9. The apparatus according to claim 8, wherein the sheath is configured to release the first prong to the second configuration in response to the sheath being in a second position, the second position being reached by pulling the sheath away from the distal end of the valve leaflet anchor.

10. The apparatus according to any one of claims 7 to 9, wherein the first prong is configured to bend at a right angle in the second configuration.

11. The valve leaflet anchor, A first prong that can operate in the first configuration and the second configuration, The second prong, The device comprises a joint that connects the first prong and the second prong at a point away from the distal ends of the first and second prongs, The apparatus according to claim 2, wherein in the first configuration, the first prong is pressed against the second prong, and in the second configuration, the first prong is separated from the second prong.

12. The apparatus according to claim 11, wherein, in the first configuration, the first prong and the second prong are configured to hold a portion of the valve leaflet between them.

13. The apparatus according to claim 12, further comprising a sheath configured to press the first prong against the second prong in the first configuration.

14. The apparatus according to any one of claims 1 to 13, wherein the primary guide wire is operable independently of the secondary guide wire.

15. A guide wire configured to be removably attached to a valve leaflet via a valve leaflet anchor, wherein the valve leaflet anchor is A first prong that can be operated in both closed and open configurations, The second prong, The device comprises a sheath configured to move from a first position, where the first prong is compressed relative to the second prong to form a closed configuration, to a second position, where the first prong is released from the second prong to form an open configuration. A guide wire in which, in the open configuration, the first prong separates from the second prong to form a hook, and in the closed configuration, the first prong together with the second prong to form a needle.

16. The guidewire according to claim 15, wherein the leaflet anchor is in the closed configuration when inserted through the proximal surface of the calcified leaflet, and the leaflet anchor is in the open configuration when it is hooked onto the distal surface of the calcified leaflet.

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