STENT WITH VALVE FOR ORTHOTOPIC REPLACEMENT OF DYSFUNCTIONAL HEART VALVE AND DELIVERY SYSTEM

专利摘要:
this invention reveals a stent with a valve for implantation in a dysfunctional or diseased atrioventricular valve ring. the valve stent is expandable from a retracted shape to an expanded shape for minimally invasive delivery and has a low profile in the atrial or superior aspect to achieve improved hemodynamics and offer the ability to manufacture large diameter replacement valves. the invention also includes a delivery device designed exclusively for implantation of the valve stent and offering the potential for controlled and accurate positioning of the valve stent in the atrioventricular ring. the invention also includes methods for using the above devices and for treating diseased atrioventricular valves.
公开号:BR112019023672A2
申请号:R112019023672-4
申请日:2018-05-14
公开日:2020-06-02
发明作者:Quijano Rodolfo；Bertwell Ryan
申请人:Navigate Cardiac Structures, Inc.；
IPC主号:

专利说明:

Invention Patent Descriptive Report for: STENT WITH VALVE FOR ORTHOTOPIC REPLACEMENT OF DYSFUNCTIONAL HEART VALVE AND DELIVERY SYSTEM
FIELD OF THE INVENTION
[001] The present invention discloses a valve stent for the replacement and restoration of the function of defective heart valves and a specific system for delivery and implantation under controlled conditions. More specifically, the invention reveals preferred geometries and critical dimensions for the structure of prophetic valves when anchored in the native valve ring to improve fluid dynamics through the prophetic valve and nearby vasculature. The invention also includes a transluminal delivery system that implements the replacement valves using the ideal positioning to ensure proper fixation and subsequent operation, while minimizing surgical complications.
BACKGROUND OF THE INVENTION
[002] The four valves found in a normal heart, the pulmonary, aortic, tricuspid and mitral valves, have a specific shape and function. The main function of the four valves is to maintain blood flow unidirectional, opening and closing at coordinated and specific times during the pulsating heart cycle. In this way, blood is collected from all tissues in the body and returned
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2/77 through the veins to the right side of the heart through the right atrium (AR) and passes through the tricuspid valve. This valve, the gateway to the heart and part of a physiological structure that is a continuity of a ring (poorly defined histologically) attached to three differently shaped valve leaflets that do not have free edges, as found in aortic and pulmonary. The edges of the tricuspid valve are attached to the tendon cords, which are attached to the walls of the opposite myocardium or cardiac muscle or on the distal side. Together, these components work to maintain proper valve function and structural conformation when opening and closing.
[003] The tendinous cords protect the valve leaflets against rupture or reversal when the ventricle pumps blood forward and thereby prevent valve failure that would lead to an inadequate volume of blood reaching the lungs. Consequently, as the right ventricle contracts and pushes blood forward, the tricuspid valve needs to close behind the flow to maintain competence to ensure that most of the blood volume inside the ventricle is pushed through the pulmonary valve to reach the lungs for oxygenation.
[004] Continuing in a unidirectional flow, the oxygenated blood flow enters the left side of the heart
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3 / ΊΊ through the left atrium and subsequently in the left ventricle through another atrioventricular valve known as the mitral valve. Similar to the tricuspid valve, the mitral valve leaflets are attached to a ring on the atrial side and to the tendinous cords on the ventricular side, which are attached to the left ventricular (LV) myocardium and in the same way as to the tricuspid valve. When the mitral valve is closed, the left ventricle then contracts to propel oxygenated blood through the aorta to all tissues in the body. To provide oxygen flow throughout the body, the pumping action of the left ventricle must reach magnitudes greater than that of the RV, as can be seen from the difference in magnitude of the ventricles, the instantaneous pressure can be expressed mathematically, a change in pressure as a function of time (dp / dt). The dp / dt of the left ventricle in the normal resting state of a seated person is in the order of 1,600 mmHg / s and this pressure is exerted on the mitral valve when closed. On the other hand, the tricuspid valve on the right side of the heart, when closed, experiences only about one fifth of the magnitude of the instantaneous pressure that the mitral valve does, a dp / dt of about 350 mmHg / s.
[005] Although both the tricuspid valve and the mitral valve are atrioventricular valves, the differences in size, structure, position and shape, and the
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Α / ΊΊ Most importantly, the size of the tricuspid valve requires that a replacement valve bioprosthesis designed especially for the tricuspid valve be different from that of a mitral valve.
[006] The replacement of the valve may be necessary due to illness, injury or purely by aging. For decades, surgical methods of valve repair or replacement have required open chest surgery, stopping the heart, connecting an extracorporeal circulation machine, and surgically opening the heart to access the diseased valve. Even when successful, the surgery required a long stay in the hospital and the risk of numerous complications that were often fatal. These disadvantages have led researchers and clinicians to look for a less invasive procedure for replacing the heart valve. Catheter-based interventional procedures, such as the placement of stents to expand obstructed arteries, were well known as minimally invasive procedures in cardiology at the time, and researchers began to examine the potential for replacing defective heart valves with the use of a catheter-based delivery.
[007] An artificial valve was first successfully implanted with the use of a catheter by Andersen in 1989 in an animal model. The ability to use
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5/77 a catheter-based delivery system would make valve replacement surgery available to a large number of patients who would otherwise have been disqualified based on the existence of comorbidities that place the patient at a high risk of mortality from surgery under cardiopulmonary bypass. Over the years, other advances have improved valve replacement procedures. In September 2000, Bonhõffer implanted a bovine jugular valve preserved with glutaraldehyde using a platinum-iridium stent to support the valve at the distal end of a 6 mm catheter, in a porcine bioprosthesis inside a pulmonary valve conduit that was dysfunctional in an 11-year-old child. This was the first catheter-guided valve implant in a human. Cribier followed this in 2002 with implants in the aortic position using a balloon-expandable replacement valve with a valve made from animal tissue contained in a stainless steel stent support structure.
[008] A series of replacement valves for semilunar valves, the pulmonary and aortic valve, using a valve stent design followed in the next decade until the use of these types of replacement valves and minimally invasive procedures for its delivery become routine and be used worldwide
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6 / ΊΊ to replace defective native valves. Stents with valves for the valves where blood flow enters and exits the heart, the aortic and pulmonary valves, are now available in many different designs and, in recent years, new developments for the exchange or atrioventricular valves, the mitral valve and the tricuspid valve, are currently being tested.
[009] Minimally invasive catheter-based techniques have been applied to access different valves in any direction in relation to blood flow, that is, by retrograde means that advance the catheter in the opposite direction to blood flow, or by anterograde means that advance the catheter in the same direction as the blood flow. Access to the tricuspid, transluminal or transatrial valve (a surgical procedure with a beating heart) is anterograde.
[010] When the tricuspid valve becomes dysfunctional and unable to close properly, the heart's ability to provide adequate unidirectional blood flow is lost. As the right ventricle (RV) pumps to move a volume of blood to the lungs, some fraction of the blood volume reverses direction and returns to the right atrium (RA) which causes retrograde blood flow through the inferior vena cava ( IVC) for the liver, kidneys and lower limbs, as well as in
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7/77 direction to the brain through the superior vena cava (CVS). The severity of regurgitation can be classified as trivial, mild, severe, massive and torrential.
Severe regurgitations are a serious condition that also results in improper blood return to the heart. The liver suffers and develops what is called cardiac cirrhosis (actually liver cirrhosis), generalized edema and ascites, accumulation of serous fluid in the abdominal cavity, also called abdominal or peritoneal hydrops or hydroperitoneum. The reduced flow of venous blood also reduces the oxygenated blood flow from the lung to the heart and, as a result, all tissues in the body suffer.
[011] As with other valves, the incompetence of the tricuspid valve is not self-repairing and, without proper treatment, an inexorable path of deterioration leads to fragility and death. With reference to Figures 3A, 3B and 4 in this document, the published literature (Nath J et al., JACC 2004 43 (3) 405 to 409) showed that the prognosis for tricuspid regurgitation (TR) is very low, mortality in one year was shown to be 9.7% for patients with mild RT, 21.1% for moderate and 36.1% for patients with severe tricuspid regurgitation. Most patients, as shown by Vahanian et al. (Eur Heart J 2012 33 (19): 2451 to 2396) are not submitted to cardiac surgery
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8/77 because they are considered inoperable (with a high risk of mortality), with a one-year mortality rate of around 37%. In its severe stage, patients with RT have very little choice of therapy to correct the condition. In the USA, studies have estimated that the number of annual patients with moderate to severe tricuspid regurgitation (RT) is 1.9 million and less than 8,000 annually receive surgical treatment that can prolong their life. The numbers can be significantly higher in Europe. Stuge O., Liddicoat J., et al. JTCS 2006; 132: 1258 to 61 (see figure 3A); Bernal UM, et al. J Thorac. Cardiovasc Surg. 2005; 130: 498 to 503; Taramasso M et al. J Am Coll Cardiol. 2012, -59: 703 to 710.
[012] The worldwide number of patients in the final stages of tricuspid regurgitation is estimated at millions and is growing due to the fact that the disease is associated with aging. Patients with RT become inoperable or at-risk patients for surgical procedures bring them more than 35% to 40% risk of mortality. The treatment currently provided consists of diuretics in blood pressure medications that are not effective due to the fact that the route due to the problem is a dysfunctional valve. Long term. These patients tend to suffer from Right Heart Failure (FCR), severe ascites, pleural effusion
Petition 870190115785, of 11/11/2019, p. 27/124 °> / ΊΊ bilateral and severe peripheral edema and often require monthly treatment for diuresis due to thoracentesis and paracentesis and torrential tricuspid regurgitation that leads to progressive frailty, with cardiac cachexia, congestive liver disease, renal failure, refractory ascites and pleural effusions. At this point, the quality of life of these patients is very poor and the prognosis is bleak.
[013] Both mitral and tricuspid valves, due to their location and their complex structure in relation to the other two valves in the heart, present many difficulties when considering a catheter-based repair or replacement. Navigation through the vasculature with valve replacement delivery devices, which are necessarily large enough in diameter to carry a replacement valve, may be possible if the profile of the delivery device can be reduced to an approximate size of the narrower vessels by which the device needs to pass to deliver the prosthetic valve to the destination location inside the heart without open surgery, although the replacement valve can be designed to retract to a smaller diameter to fit within a catheter-based delivery device used during percutaneous replacement intervention, there are limits to the smallest diameter
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10/77 possible that can be created for a replacement valve. These delivery catheters also need to be able to bend to form acute angles, as acute angles are required to reach the target locations for some defective heart valves.
[014] In addition, when the distal end of the delivery device containing the replacement valve reaches the target location for valve replacement, the delivery catheter and the replacement valve stent, then in a contracted or retracted state within of the delivery system, it must be able to approach the plane in which the native valve exists in a configuration such that the direction of approach of the replacement valve is perpendicular and coaxial to the plane of the defective valve. Appropriate delivery mechanisms to achieve this attitude need to be part of the delivery devices to be maximally compatible in form and function with the replacement valve.
[015] One of the main difficulties that must be overcome to create a properly adjusted tricuspid valve is the absolute size of the bioprosthetic replacement valve. In a human without valve disease, the diameters of the normal tricuspid valve have very specific size ranges. The aortic valve in normal adult humans ranges from about 18 mm to about
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11/77 to 29 mm in diameter and the pulmonary or pulmonary valve is generally smaller, between about 17 to about 25 mm in diameter. The atrioventricular valves, the mitral valve on the left side of the heart, vary from 25 to 30 mm or 31 mm, but the tricuspid valve is generally larger than the mitral valve and is usually about 27 to about 33 mm in diameter.
[016] What exacerbates the problem for the design of the replacement valve is the fact that the size of a valve can be dramatically affected by disease or aging. In addition, aging and disease can cause material deposits in the valve tissues that stiffen the valve tissue and narrow the valve size, decreasing the diameter of the fluid passage. This condition is called stenosis and decreases the effective size of the valve orifice and requires the ventricle to work harder to pump blood through a smaller orifice, which requires increased pressure to pump blood effectively and an increasing and undesirable pressure gradient. between the atrium and the ventricle. With increased pressure gradients and, even though the heart works harder, decreased blood flow is the inevitable result.
[017] Currently, several researchers have initiated valve replacement approaches, as opposed to repair devices for use in the tricuspid position. At the
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However, a viable replacement valve must address tricuspid regurgitation and cover and capture the wide ring diameter of the dysfunctional tricuspid valve. Atrioventricular valve regurgitation and specifically functional tricuspid regurgitation (FTR) is common in dilated cardiomyopathy (DCM), although the valve leaflets remain unchanged, the expanding diameter of the ring prevents the ability of the valve leaflets to attach, to achieve coaptation , to provide closure to prevent retrograde flow. The researchers found that orthotopic implantation of a bioprosthesis in a native human valve that had to expand to an abnormal diameter through the disease and became regurgitant is not possible with most bioprosthetic valves that were developed for aortic, pulmonary and mitral replacement due its configuration and size cannot involve this dilated ring and restore valve function.
[018] For this condition, the greatest treatment effort has been directed to the so-called implantation of the so-called valve in valve (ViV) of stents with smaller cylindrical bioprosthetic valves in failed surgical porcine rings or previously implanted pericardial or annuloplasty bioprostheses. Examples include the Sapien transcatheter aortic bioprosthesis (cylindrical in
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13/77 sizes 21 to 29 mm) and the Melody transcatheter pulmonary bioprosthetic valve (cylindrical in sizes 14 to 22 mm) were implanted in these surgical bioprostheses with failure in the bioprostheses with both tricuspid and mitral failure with relative success. Other efforts when unable to correct tricuspid regurgitation sought to alleviate many of the adverse effects of tricuspid regurgitation, such as liver cirrhosis, kidney failure, peripheral edema and ascites, resorted to valve stent implants implanted in both the inferior and superior vena cava to prevent flow retrograde and pressure in both veins that can be transmitted to all of these organs.
[019] Currently, no known prophetic valve design is capable of encompassing, grasping and maintaining hemodynamic flow when the dimensions of the diseased atrioventricular valve ring are greatly increased. In addition, the deposition of large valves that, on average, approach 49 mm, and some that reach diameters in the lower 60 mm, requires well-controlled orientation and release of the valve during implantation, so that the valve enters coaxially in the center the tricuspid plane and results in the replacement valve gripping and grasping the dilated ring. So, a special catheter that has an articulation that would allow a change of direction when it reaches a certain point in the right human atrium, that direction
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14/77 then points the distal orifice of the replacement valve to the central point of coaptation of the leaflets of the tricuspid valve.
[020] Additionally, when this catheter has entered the incompetent tricuspid valve, it would allow, in a completely controlled way, the initial release of the distal orifice of the valve stent, so that special features of the valve stent implant and initiate the engagement of the soft part of the leaflet without damaging or breaking the strings that connect to the floating margin of the leaflet. A special device needs to be made to allow the release of the proximal configuration of the stent with a valve that secures the joints and leaflet ring on the atrial side in a fully controlled manner and fully allowed by the operator's hands and visual navigation. This sequence needs to be performed with great care to ensure that the atrioventricular stent is positioned correctly, without deviation or inclination, so that a complete adjustment is made to the incompetent tricuspid apparatus and without the permission of the passage between the chambers (ventricle to the atrium or the reverse) of blood around the periphery after the valve stent is released, that is, without leakage. In addition, it is extremely important to perform these operations as described and keep in mind that the proximal orifice of the stent has members that must be kept away from the
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15/77 components of the conduction system neighboring the heart to prevent heart block, which is the disturbance of the conduction system that results in the interruption of the electrical activity of the heart that energizes its contraction and relaxation, leading to the cessation of the heart rhythm and pumping of blood - a lethal outcome, unless rhythmic stimulation is instituted. In addition, it should be noted that tricuspid regurgitation can be caused by cardiac pacemaker electrodes that restrict the function of valve leaflets, and there are a large number of patients with this condition.
[021] Thus, it would be desirable to provide a prophetic valve that has achieved design parameters that allow the replacement of a dysfunctional valve with a valve design that achieves safe anchorage at the destination site, as well as improved hemodynamic properties for blood flow through the valve. and in the surrounding vasculature. The prophetic valve must restore the almost natural function of the valve and does not need to protrude into any chamber as it would cause disturbances and flow patterns (turbulence) known to lead to thrombosis and thromboemboism.
[022] It would also be desirable to provide a delivery system to allow a minimally invasive surgical procedure to anchor a replacement valve.
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16/77 at the destination site in the patient's heart, implanting the prosthetic valve to grasp the dilated ring of an incompetent tricuspid valve and involve the passage of the entire blood flow to create a stable and effective replacement valve. Ideally, the delivery system can be used in a retrograde or anterograde approach to deliver the valve through controlled release and precise positioning at the destination. Taken together, the controlled release and safe placement of a bioprosthetic heart valve would minimize trauma, avoid the risk and trauma of using a heart bypass machine, reduce surgery time and create better long-term results compared to existing open chest devices, delivery systems and surgical procedures.
SUMMARY OF THE INVENTION
[023] The present invention relates to the restoration of function of the cardiovascular valves, including repair and replacement of any of the four heart valves, but, particularly, to the positioning of prophetic substitutions for the atrioventricular valves. The invention also includes devices and methods using an integrated system comprising replacement valves and a delivery system specially designed for use with the replacement valves of the invention. The system is
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17/77 comprised both by the stent with a specific valve for a target valve, for example, the tricuspid or mitral valve, and by a delivery system also specific to the target valve. Thus, the invention is understood by each of the two devices individually and in the complementary combination of the separate devices.
[024] The methods of the invention include techniques for controlled implantation of the prosthetic valve that are permitted by the unique design of the delivery system and the valve. In particular, these mechanisms allow for controlled implantation and release of the prosthetic valve, so that the surgeon can carefully control the positioning of the valve at the destination site and dictate the expansion rate of the replacement prosthesis during delivery and ensure the arrival of the stent with valve in the appropriate zone during implantation.
[025] Specifically, the invention provides a stent with a valve for implantation in a native valve ring, preferably an atrioventricular valve, which comprises: a support structure, in which the support structure is expandable from a retracted format to an expanded format ; a tissue valve that has at least one leaflet, the tissue valve being connected to the support structure; and the upper and lower means for fixing and stabilizing the valve
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18/77 stent in the valve ring, in which the means to fix and stabilize the valve stent are located in an external circumference of the support structure. The fixation and stabilization of the valve stent in the native ring can also be described with fixation and stabilization structures in both the atrial (upper) and ventricular (lower) portions in relation to the native valve ring. Critically, the fixation and stabilization means provide a carefully controlled profile for the overall dimension of the prosthesis, including relative dimensions for height and width that control fluid dynamics both through the orifice of the replacement valve and in the proximal and distal regions of the valve in that fluid dynamics and relative fluid flows affect the permeability, thrombogenicity and long-term durability of the replacement valve.
[026] In an additional embodiment, the support structure of the stent valve is self-expanding to predetermined dimensions that are selected to correspond to a diameter of the dysfunctional valve ring. In some embodiments, measuring the size of the replacement device for an atrioventricular valve that has become dysfunctional due to the dilation of its ring, takes into account that the ring will be captured together with the valve leaflet material by the anchoring elements,
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19/77 fixing and stabilizing the stent with valve. Functionally, these elements grab the fabric that surrounds the native ring using a pair of structures or sets of structures in which each moves from a first position to a second position. The implantation occurs substantially at the ends of the movement range for the structures and can be coincident with the general structure of the valve stent that moves from a retracted or restricted configuration to the expanded configuration for the final positioning of the native ring. The implantation can also be coincident with the change from a first temperature to a second temperature that can activate the change in the configuration of a memory element in the form of a stent with a prophetic valve.
[027] The unique mechanical properties of the temperature memory alloy undergo phase changes in the solid state due to increased deformation or temperature change that leads to a unique strain and stress ratio. This stress response is called superelastic and refers to the alloy's ability to undergo an applied tension that changes its molecular crystal structure, that is, it undergoes a phase change from an austenite to a martensite phase end with elastic deformation reversible up to 10%. The thermal response, shape memory, is a phase transformation due to the
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20/77 material temperature changes.
[028] In an additional embodiment, an angle of a first gripping element in the distal orifice near or in the flow inlet portion of the support structure rotates from a first position to a second position according to the distal confinement capsule of the stent catheter with valve is removed and the distal or vent efflux orifice emerges at room temperature (blood) and, at the most distal ends of the first, the tissue engaging element radially implanted at an angle between about 40 ° and 50 ° ° from the surface, preferably about forty-two to about 46 ° and both are exposed to body temperatures. The tips of the ventricular teeth are positioned to be spaced between the adjacent tendinous cords. The space formed by the regions that engage the tissue and the outer circumference of the stent support structure becomes a cavity where the portion of the valve leaflet between the tendinous cords is captured. Similarly, as the operator additionally removes the distal capsule, the tips of the proximal or atrial gripping elements in the form of wings, now a cylindrical bead, become exposed to room temperature (blood temperature), at the point where the engaging elements are implanted radially in the distal direction in
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21/77 towards the tips of the distal inflow orifice at a predefined angle. The angle is between 80 ° and 95 ° and preferably approximately 90 ° (see Figure 5C). The resulting gap between the upper (atrial) and lower gripping elements, for a given size of a dysfunctional valve and valve stent, accommodates leaflets, leaflet joints and the native ring in a way to provide anchorage and boundary around the orifice interchamber. The atrial teeth form an annular skirt that rests on or near the bottom of the atrial chamber and performs a gripping function in it.
[029] In an additional embodiment, the valve expands from a retracted to an expanded configuration according to a differential temperature gradient that has a first temperature of the gripping elements between about 0 ° C and 8 ° C, preferably between about 4 ° C and 16 ° C and a second temperature for the expanded configuration, where the second temperature of the gripping elements is between about 20 ° C and 45 ° C, preferably between about 35 ° C and 40 ° Ç.
[030] It is another objective of the invention to provide a method of delivering a stent valve through a blood vessel to a target native valve site adjacent to a valve ring, comprising the steps of: advancing a stent valve that has a valve fabric with at least
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22/77 a leaflet and a support structure, the fabric valve being connected to the support structure, where the support structure is expandable from a retracted format to an expanded format, where the support structure has a frame stent means and comprises gripping means for fixing and stabilizing the stent valve on the valve ring, when the gripping means are comprised of a first means for engaging an upper portion of the native ring and a second means for engaging a lower portion of a native ring ; pass the support structure through the blood vessel with the support structure in the retracted format; implant the stent valve in the desired valve location adjacent to the valve ring with the support structure in expanded format; and anchoring the stent valve to the valve ring with the gripping means, where the gripping function is provided by a first structure that engages an upper portion of the native ring and a second structure to engage a lower portion of the native ring.
[031] In one embodiment, the support structure of the valve stent is made of a metal with shape memory, such as Nitinol or polymer with shape memory, in which the gripping means comprises two sets of separate elements that engage the tissue close to the native ring as the entire prosthesis implants
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23/77 and changes from a retracted configuration to an expanded configuration. The implantation of the device functionally anchors the prosthesis at the destination site in the native ring. In one embodiment, the gripping function is performed by structural elements that engage the tissue close to the native ring as the valve stent expands from a first position at a first temperature to a second position at a second temperature. The preferred valve stent creates a cavity between the circumferential exterior of the device and the tissue. The cavity seen in a cross-sectional perspective of the native valve ring can be seen to be in the form of a capital J, which results in a toroidal cavity that captures the dysfunctional valve leaflet mass, leaflet joints and the ring.
[032] The valve stents of the present invention have specific and predetermined dimensions to produce favorable hemodynamic flow parameters through the replacement valve orifice and in the atrial and ventricular spaces next to the valve following implantation. As described above, specific flow conditions, both desirable and undesirable, are a direct result of the size, shape, general configuration of the prophetic valve and, in particular, the height of the device width as a function of the various sizes of the valve device
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24/77 stent.
[033] In an additional embodiment, the method of the invention includes implanting the valve stent from a restricted retracted configuration within the distal end of a delivery catheter, to a partially implanted configuration, in which the valve stent assumes a configuration partially or fully expanded, followed by the retained implantation in which the valve stent achieves a substantially completely expanded configuration while retaining fixation by sutures or wires implanted in the delivery system, followed by a complete implantation with the stent with valve reaching its ideal configuration and the delivery system in position for removal.
[034] In a preferred mode, the internal dimensions have absolute and relative values that are designed for an optimal blood flow dynamics. The diameter of the tissue valve is selected as a function of the size of the diseased native ring in a patient, as a function of the selection of the diameter of the tissue valve, the valve stent has a series of absolute and relative dimensions that include, however, without limitation, the total height of the valve, the height of the fabric valve, the diameter of the crown and a separation distance from the fabric that proportionally or remains constant as a function of
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25/77 diameter of the fabric valve. The invention includes predetermined limits on dimensions or proportions of dimensions for selected measurements of critical valve structures, as described in further details below.
[035] In an additional modality, the implantation step is performed by self-expansion of the stent support structure with a valve from the retracted format to the expanded format or with an inflatable balloon.
[036] In an additional modality, the blood vessel through which the valve stent passes is one or more of the internal jugular veins, the superior or inferior vena cava, axillary vein, or subclavian vein, femoral and illaca veins.
[037] Of particular interest in the present application are techniques for implanting an atrioventricular valve that can be retracted or folded within a delivery system or cannula for delivery through less invasive intercostal penetration to the desired location, particularly in an atrium right. Subsequently, the contracted or crimped valve is released, expanded, separated from the delivery system and secured in the desired location with anchoring mechanisms that do not unduly alter the vicinal structures, such as tears or perforations, and it is able to withstand the continuous impact of blood that closes the leaflets with pressure
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26/77 without impelling it or dislodging it from its intended place.
[038] The delivery system was designed to house the valve stent in the retracted position for delivery. The valve stent is encapsulated at the distal end of the device and has a profile diameter of approximately 35 F OD. The profile diameter is deliberately designed large due to the following design criteria, which include, however, without limitation: ensuring the safety of the procedure, safety, precision and consistency of delivery of the device, so that the intended arrival receives the bioprostheses of a controlled manner with safety, precision and consistency and to avoid incorrect positioning of the valve stent that can result from the undesirable and rapid spring effect of the shaped memory metals during the release of a retracted condition to an expanded condition. The slow release, as controlled by the operator, will minimize reaction forces due to the compressed and restricted valve stent expanding rapidly to the predetermined and selected diameter.
DESCRIPTION OF THE FIGURES
[039] Figures IA and 1B show a section of the heart to reveal internal structures that characterize the normal blood flow path (Figure IA) on the side
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27/77 right from the heart. Figure IB illustrates a defective tricuspid valve that allows reflux of blood to the right atrium, so that surgical intervention is indicated.
[040] Figures 2A and 2B show an abnormally enlarged tricuspid valve including the defective valve ring dimensions in Figure 2B. Specifically, Figure 2A shows a photograph of a human tricuspid valve that is defective as a result of excessive enlargement and the resulting inability for the leaflets to collapse, thereby being unable to close completely to prevent retrograde flow. Figure 2B illustrates the use of an exact obturator ring, which exemplifies abnormal valve dilation to a diameter of 48 mm, a dimension that impedes normal heart function.
[041] Figure 3A graphically illustrates the prevalence of tricuspid regurgitation in the United States population and reveals the extent of undertreatment of the condition.
[042] Figure 3B graphically illustrates the relationship between the selected forms of tricuspid valve dysfunction (incompetence or regurgitation) and the relationship with increased mortality rates in the short to intermediate term. Specifically, Figure 3B reveals the rapid increase in mortality in patients with
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28/77 tricuspid regurgitation (60% mortality rate in three years).
[043] Figure 4 illustrates the effectiveness of traditional surgical repair, rather than complete replacement, of incompetent tricuspid valves. The data indicate a high failure rate for traditional valve repair surgery. FR = - free repair: sutures that join leaflets and open heart surgery; RR = ring repair: sutures + annuloplasty ring; Kay = sutures positioned especially inside the valve to bring leaflets for coaptation; Et-E + Kay = Edge-to-edge approach of valve edges plus sutures at the commissures. The lines represent repair failure year after year, indicating that a substantial majority of open-heart and catheter-guided repairs fail.
[044] Figures 5A to 5C are a stent frame structure with a valve to support the valve mechanism of the bioprosthetic valve stent of the invention to replace a dysfunctional atrioventricular valve, preferably by minimally invasive percutaneous surgery. Figure 5A shows the general stent geometry dictated by the support structure of Figure 5B, which shows individual configurations, distances, angles and absolute and relative parameters, as illustrated by Figure 5B. These geometries and relative relations are
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29/77 further illustrated in Figure 5C and Table I.
[045] Figures 6A to B show several modalities of a percutaneous valve in which the valve mechanism was positioned inside the truncated cone stent. Due to the geometric configuration, valve stents can be manufactured by those skilled in the art, in sizes that are generally twice the size of the normal tricuspid valve, which reach and exceed the diameters of the rings found in patients with RT, that is, greater than 48 mm and in the 60 mm range.
[046] Figures 7A to 7B are a modality of the valve stent of the present invention seated on the native valve ring, which shows, for example, the position in relation to the atrial skirt in the modality positioned close to the bottom of the left atrium. tendinous cords located between the ventricular teeth of the valve stent.
[047] Figures 8A to 8C show a modality of the distal end of the delivery catheter for delivery and implantation of a stent with balloon-expandable valve with a capsule, alignment pins and a conical tip.
[048] Figures 9A and 9B are a flap support located at the distal end of the delivery catheter that organizes the release wires, facilitates the direction control of the distal end of the delivery catheters and the
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30/77 controlled release of the stent with valve.
[049] Figure 10 is the delivery system of the present invention, which illustrates a cable for selective operation by the surgeon to manipulate the delivery system for delivery of the valve stent, as described in this document.
[050] Figures 11A to 11B show details of the capsule and related components of the delivery system of the present invention, including a distal tapered tip.
DETAILED DESCRIPTION OF THE INVENTION
[051] Objectives and additional resources of the present invention will become more apparent and the invention itself will be better understood from the Detailed Description of the Invention below, when read with reference to the accompanying drawings.
[052] Referring to Figures 1 to 11, a valve stent and delivery system are shown for repair and replacement of an atrioventricular heart valve. Although the design of the valves of the present invention offers advantages, even in open-heart surgical procedures, the valves of the invention are specially designed to be introduced through a blood vessel in a retrograde or anterograde manner, with the use of minimally invasive procedures, which include transvascular, laparoscopic or
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31/77 percutaneous using a delivery system to facilitate surgical placement of the valve stent as a prophetic cardiac replacement valve.
[053] Tricuspid regurgitation or tricuspid incompetence is a disease of the atrioventricular valve on the right side of the heart, characterized by the inability of the valve to close during systole, when the right ventricle contracts to expel blood from the cavity towards the pulmonary valve and to the lungs. The valve orifice remains open most of the time and allows the flow to reverse at the level of the tricuspid valve. In fact, only a small amount of blood can be ejected through the right ventricle, which needs to increase the volume of the ventricular chamber markedly (increase in size) and the pressure to pass through the orifice.
[054] The prophetic heart valve of the present invention can be described as a stent assembly with a valve because it has a set of required structures: 1) a synthetic valve portion that extends substantially over the entire diameter of the support structure; 2) a stent-like support structure that surrounds and maintains the integrity of the valve prosthesis; 3) a pre-cut polymeric mesh material 23 that substantially covers the entire inner surface of the support structure and 4) fabric engagement structures that
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32/77 perform the function of grabbing the native ring tissue to firmly anchor the replacement bioprosthesis after implantation. The term valve stent assembly can be used herein to describe properties that are derived exclusively from the above combination of structures, but it is generally interchangeable with the term valve stent that is used throughout.
[055] The stent assembly with a prophetic valve includes a portion of the valve made from natural or synthetic fabric and has at least 2 leaflets attached to the commissure portions. If the natural valve has three leaflets, the leaflets are preferably formed of substantially equivalent size and shape and geometrically oriented to cover the entire circumference of the valve stent. The valve prosthesis is connected to the structural frame supporting the stent with a valve at the adjacent junction margins of the leaflets in dedicated vertical structures, integrated with the structural frame. The valve leaflets are produced from a suitable synthetic or non-human pericardium tissue, typically collected from sheep, goats, bovine or equine species and are chemically treated with buffered solutions that have a low concentration (0.25%) of glutaraldehyde and derivatives glutaraldehyde that allow the valve stent to be packaged for sterilization without a solution of
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33/77 accompanying storage. The material of the valve stent leaflet is formed in a valve prosthesis mounted so that the individual valve leaflets do not come into direct contact with the structural support member of the stent, but only with a microfiber cloth that covers the internal circumference of the stent. structural support member of the stent. Although precise dimensions of the valve stent are given below for several different diameters, the valve stent can be manufactured in sizes that can extend to at least 64 mm and is greater than 70 mm with equivalent dimensions, as described in this document for valves with smaller diameters.
[056] The stent has a structural frame support 11 which is preferably made of Nitinol alloy or other similarly shaped metal or polymer. The stent configuration is preferably laser cut from an 8 or 10 mm hypotube and the shape is thermomechanically defined for a predetermined orientation, as shown in the series of Figures 5 and 6. The commissure bars 30, 31, 32 they are also made of Nitinol alloy and support the valve commissures by attaching to the valve commissures along its length. In the embodiment of Figures 6A and 6B, three commissure bars 30, 31, 32 spaced at 120 °, as appropriate for a three-leaf valve construction.
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3 ^ / ΊΊ
[057] pr pre-cut polymeric fiber mesh material 23 is preferably a laser cut microfiber polyester cloth to conform to and be substantially the size of the internal circumference of the valve stent support structure and covers the entire internal surface the stent before mounting the valve. In a preferred embodiment, a precut annular segment separated from the mesh material 23 is dimensioned to cover one or both of the upper or lower surfaces of the annular atrial skirt and is configured to have an area at least equivalent to the entire length of the atrial teeth that form the quit annul. The mesh layer 23 of biocompatible material can be synthetic, such as polyester (for example, Dacron®) (Invista, Wichita, Kans.), Woven velvet, polyurethane, PTFE, ePTFE, Gore-Tex® (WL Gore & Associates, Flagstaff, Arizona) or heparin-coated cloth. Alternatively, the layer may be a biological material, such as bovine, caprine, equine and / or porcine pericardium, peritoneal tissue, pleura, submucosal tissue, dura mater, an allograft, homograft, a patient graft or cell-seeded tissue.
[058] The pre-cut mesh layer 23 can be attached separately around the entire circumference of the valve 10 stent in a single piece or can be attached to interrupted parts or sections to allow the limb
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35/77 expandable support expands and contracts more easily. As shown in Figure 6B, for example, all or a portion of the annular skirt can be covered with the pre-cut mesh layer 23. The pre-cut mesh layer 23 can also be attached to the stent support structure at intermediate points along its height and can comprise a single layer formed only on the internal circumference of the support structure of the valve stent.
[059] Preferably, the structures that perform the gripping function to anchor the bioprosthetic valve in place are composed of two separate tissue engagement structures that are spaced along the height of the supporting structure, so that portions both atrial or of inflow as well as ventricular or efflux, of the stent assembly with valve are attached separately to both sides of the native ring. In one embodiment, the upper and lower tissue engagement structures are comprised of atrial and ventricular teeth. Atrial teeth can be formed to collectively form an annular structure that rotates into position by expanding the valve stent from a retracted to an expanded configuration. The engaging elements of the atrial and ventricular tissue are preferably cut from the hypotube used to manufacture the structural support element of the
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36 / ΊΊ stent. Upon rotation to the implanted configuration, the atrial annular tissue engagement structure has substantially flat upper and lower surfaces that extend radially in approximately 90 ° orientation with respect to a central vertical and linear geometric axis of the valve stent and rotate towards form an annular ring or skirt to engage the native ring tissue on the atrial side. The atrial teeth can be formed by individual inverted V-shaped wings that are separated uniformly and arranged around the inflow of a low profile crown. Once implanted, the lower surface of the annular skirt rests on the atrial side of the native ring. Together with the ventricular teeth, the atrial teeth form an external space that captures the native dysfunctional valve leaflets and the native ring.
[060] In the exemplary embodiment of Figures 5 and 6, twelve ventricular teeth are intended to grasp the three tricuspid leaflets on the ventricular side. Like the rest of the support structure, the ventricular teeth are shaped to extend outside the plane of the valve stent body. The number of teeth is not critical, as long as the number is adequate to perform the function of engaging the tissue, as described in this document, so that the gripping force is adequate to hold the leaflets of the native valve and prevent the
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37/77 valve migration.
[061] In one aspect, implanting the bioprosthetic valve to replace a dysfunctional native atrioventricular valve (tricuspid or mitral) with the use of the valve stent of the present invention does not involve excision of the natural leaflets or removal of the native valve, as is done in surgery open heart. Instead, the prophetic heart valve fixation includes a gripping function that anchors the valve stent inside the native valve ring, so that the native valves are permanently retracted against the walls of the native ring. The gripping function includes the retraction of native leaflets, stable anchoring of the prophetic in place and secure engagement by a plurality of structures that perform the gripping function without drilling or penetrating the tissue in or near the native ring. In the presence of pacemaker electrodes or automatic defibrillator (AICD) that pass through the native tricuspid valve, as is the case in patients with severe tricuspid regurgitation, the electrodes need to be pushed by the stent against the ring and native leaflets without damaging the electrodes or interference with their function. The design of the support structure allows the electrodes to fall within areas between the coupling structures (such as the ventricle teeth described below), so that the electrodes
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38/77 can be positioned between them and pressed against the native fabric without damage.
[062] For the purposes of the present invention, references to the positional aspects of the present invention in relation to the directional blood flow vector through the implantable device will be defined. Thus, the term proximal means on the upstream or downstream side of the device, while distal means on the upstream or downstream side of the device. With respect to the delivery apparatus described in this document, the term proximal means closest to the operator and the cable end of the delivery device, while the distal term means towards the terminal end or transport end of the delivery device device. In the context of atrioventricular valves, the atrial direction refers to the displacement of volume with a portion of the prosthetic valve in the left or right atrium and the ventricular direction refers to the displacement of a volume with a portion of the prosthetic valve in the left or right ventricle.
[063] The invention includes methods for delivering a stent valve through a jugular, subclavian or femoral vein, comprising the steps of: (a) advancing a tissue valve that has at least one leaflet and a supporting stent structure through a portion of the
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39/77 vasculature of a patient, in which the support stent structure is expandable from a retracted configuration to an expanded configuration, in which the outer circumference of the support stent structure which has at least a pair of separate structures for grasping tissue cardiac near the native valve ring to restrict leaflets on the ventricular side of the ring (b) implant the prophetic valve in the native ring of a dysfunctional valve by expanding the stent with the valve from the retracted to the expanded configuration; and (c) attach the valve stent to the native valve ring by expanding the valve stent to the nominal size based on a pre-selected size that corresponds to the size of the diseased native valve orifice and which has ventricular gripping elements and atrial to prevent displacement and migration, while providing a sealing function for peripheral leakage along any direction of the bioprosthetic valve.
[064] In one embodiment, the fixation step is achieved by the function of grasping cardiac tissue close to the native ring with valve stent components that comprise upper and lower elements or that are switchable to form a receptacle configured as U or C or J horizontally tilted to receive and retain annular and leaflet mass.
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40/77
[065] In a modality of percutaneous valve implantation in an anterograde manner, that is, along the direction of blood flow, in the tricuspid position, in various stages of delivery of the device, which show that the dysfunctional tricuspid valve can be addressed in an anterograde way. In one embodiment, the delivery device with a valve stent that is retracted within the distal section of the injection device is introduced percutaneously through axillary veins, the subclavian vein. Once it crosses the superior vena cava and approaches the approximate center of the right atrium chamber, the distal end of the catheter that supports the stent with an encapsulated valve is directed to the tricuspid annular plane or the location of the tricuspid valve, the section distal is positioned inside the tricuspid valve. The catheter sheath is then slowly removed in order to release the valve stent out of the distal section. In one embodiment, the support stent structure is self-expanding, the stent valve expands as it is released from the catheter sheath. When raising the temperature from the first temperature to the second temperature, as described above, the gripping means go through stages such as: the pre-implantation valve, the partially implanted valve, with a distal gripping element rotated and the valve fully implanted with both elements of
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41/77 hold properly positioned.
[066] A percutaneous valve implantation in an anterograde manner proceeds from a stent with a retracted valve within the distal section of the delivery device and is percutaneously introduced through a vein and passed through the superior vena cava or inferior vena cava. Once it passes through the right atrium of the heart and approaches the destination site of the atrioventricular valve (tricuspid), the distal section is properly positioned within the ring facing the right atrium. The catheter sheath is slowly removed in order to release the valve stent out of the distal section. In one embodiment, the structure of the support stent is self-expanding. Thus, the stent valve will expand as it is released from the catheter sheath. When raising the temperature from the first temperature to the second temperature, as described above by the body temperature, the gripping means go through stages such as: the pre-implantation valve, the partially implanted valve, a rotated distal gripping element and the fully implanted valve with both gripping elements rotated.
[067] During any stage of the procedures, it is possible to insert or use any imaging modalities to visualize the operational field. Imaging modalities may include echo
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42/77 transesophageal, transthoracic echo, 3D echo image or an injectable dye that is radiopaque. Cinefluoroscopy can also be used. In one embodiment, an imaging system can be delivered via a cannula or catheter to the operational field. The imaging system is well known to a person skilled in the art.
[068] In reference to Figures IA and 1B, the heart has four valves, two of which connect the heart to the vasculature that delivers blood to and from the heart. Referring to Figure IA, blood enters the right side of the heart through two large veins, the inferior and superior vena cava, and delivers blood without oxygen from the venous system to the right atrium of the heart. As the right atrium contracts and the right ventricle relaxes, blood flows from the right atrium to the right ventricle through the open tricuspid valve. When the ventricle is full, the tricuspid valve closes. This prevents blood from flowing back to the atria while the ventricle contracts. As the ventricle contracts, blood leaves the heart through the pulmonary valve, in the pulmonary artery and into the lungs where it is oxygenated.
[069] The tricuspid and aortic valves, respectively, act as the port of entry and exit of the heart to and from the vasculature, providing blood flow
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43/77 oxygenated to the rest of the body. These valves in their normal, unhealthy state regulate the continuity of unidirectional blood through the heart. When abnormalities or disease cause malfunction and one of the four valves, the result is an incomplete blood flow that enters the heart from the body and a complete blood flow within the heart and between the heart and a pulmonary system or an incomplete blood flow from oxygenated blood from the left ventricle of the heart to the arterial system.
[070] With reference to Figure 1B, a defective or dysfunctional tricuspid valve, sometimes called an incompetent tricuspid valve, allows an abnormal flow of blood return in a reverse direction and into the right atrium.
[071] Referring to Figures 2A and 2B, an abnormal physiology of a tricuspid valve is shown that includes the dimensions of the defective valve ring in Figure 2B. Specifically, Figure 2A shows a human tricuspid valve that is defective as a result of excessive enlargement and the resulting inability for the leaflets to collapse along their commissures, thus being unable to close completely to prevent retrograde flow. This condition is commonly associated with a heart condition known as dilated cardiomyopathy
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44/77 (DCM). Figure 2B shows the measurement of the valve shown in Figure 2A by using an exact obturator ring that exemplifies the abnormal expansion of said valve to 48 mm in diameter, an extraordinary dimension that prevents normal heart function.
[072] Referring to Figure 3A, the prevalence of tricuspid regurgitation is shown in the United States population and reveals the extent of undertreatment of the condition and, in Figure 3B, the relationship between these particular forms of heart valve dysfunction and increased mortality rates in the short to intermediate term. Specifically, in relation to Figure 3B, the data indicate a rapid decline in patients with tricuspid regurgitation and a mortality rate of 60% in three years. As is apparent from the graphs in the figures, patients with this disorder continually decline until death and do not tend to stabilize or recover due to the condition not being self-repairing.
[073] In reference to Figure 4, data were gathered to assess the effectiveness of traditional surgical repair, rather than complete replacement, for incompetent tricuspid valves. The data indicate a high failure rate for traditional valve repair surgery. Due to this data, valve repair procedures can be seen as suboptimal and an approach
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The improved 45/77 would be facilitated by catheter-guided replacement devices and methods for the complete replacement of tricuspid valves.
[074] With reference to Figure 5A to 5C, a valve stent 10 has a structural frame support 11 that acts as the structural base of the assembled structure and that contains the valve mechanism (see also Figures 6A to 6B below) of the stent with valve 10 of the invention for replacing a dysfunctional atrioventricular valve by minimally invasive percutaneous delivery. The geometry of the valve stent 10 is specially designed so that when the valve stent 10 is in the expanded configuration, a truncated cone profile is created so that the upper flow inlet opening or upper proximal orifice or atrial portion of the structural frame support 11 of the stent with valve 10 has a minimum height dimension, extremely low profile in relation to the diameter of the valve prosthesis and is smaller in diameter than the lower, lower or ventricular outlet flow opening or distal orifice.
[075] The specific design of the stent components with valve 10 is based on the low profile configuration of the structural frame support 11 in relation to the diameter of the valve prosthesis, which in turn is derived and dependent on predetermined distances, proportions of
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46/77 distances, angles and dimensions of the structural elements of the structural frame support 11 that produce superior flow dynamics as blood passes through the valve stent and is subjected to differential pressures on both sides of the valve stent 10. Specifically , the device has a low ratio between the total height of the structural member of the valve stent and the diameter of the tissue portion of the valve prosthesis, so that the differential pressure is reduced and the turbulence both proximal to the valve stent 10, or that is, the space in the atrium immediately proximal to the stent with valve 10 and distal to the stent with valve 10, that is, in the space of the ventricle immediately distal to the stent with valve 10.
[07 6] In addition to providing a central truncated cone support structure for the prosthetic valve element, the structural elements of the structural frame support 11 provide support for the first and second fabric engaging elements that grip the fabric on the side both atrial and ventricular of the native ring and form a cavity between them. After complete implantation of the valve stent 10 for the expanded configuration, the final position of the pair of tissue engaging structures and the outer circumferential area of the valve stent frame form a cavity
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47/77 toroidal which encloses the native valve leaflets and bring the stent assembly with entire valve 10 in conformity with the internal annular circumference of the native valve ring.
[077] The stent assembly with valve 10 is comprised of a structural stent frame 11 that has individual diamond-shaped subunits 12 usually in overlapping circumferential rows and made of a tubular material with memory from which a predetermined quantity and pre-projected material has been removed along a length of the same allowing the support provided by the structural frame of stent 11 to be transformed from a collapsed tubular shape to an expanded configuration, so that the proximal / atrial or inflow orifice is smaller than the distal / ventricle or outlet.
[078] The individual struts 13 of the structural frame assume a predetermined configuration due to the thermally adjusted memory properties of the material from which the structural frame support 11 is manufactured. The individual struts 13 can be joined along a length of them in joints 14 which are equally spaced along the length of the individual struts 13 that form a
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48/77 individual diamond-shaped subunit 12 of the structural frame support 11. In the atrial or top / top dimension of a subunit 12 of the structural frame support 11, the individual struts 13 are joined in an upper connector 15 which is also preferably joined to a plurality of atrial teeth 19 which are positioned circumferentially around substantially the entire upper interior surface of the valve stent 10. In the embodiment of Figure 5A, the atrial teeth can be manufactured to define an inverted V formation similar to those structures that form the crown 20 and are rotatable about a circumferential geometric axis of the structural frame support 11, so that the annular skirt 19 formed from the plurality of atrial teeth, and the entire construction of the crown 20 are substantially collinear with the other structural support structures 11 when the stent with valve 10 is in the retracted configuration and rotates in the expanded configuration to be implanted radially outward at an angle between approximately 80 ° and 100 ° and preferably approximately 90 ° with respect to a vertical central axis of the stent with valve 10. Referring to Figures 5A and 5C and Table I below, the dimensions, relative dimensions, angles, as specified, show a preferred modality of
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49/77 stent assembly with valve 10 after implantation with the dimensions, angles and proportions defined above by the support of structural frame 11 after implantation and assuming the fully expanded configuration.
[079] At the upper end of the structural frame support 11, the crown 20 extends above the circumferentially extended annular atrial skirt 19 after implantation. The annular atrial skirt 19 acts as a first tissue engagement structure that preferably rests on the atrial floor in the expanded stent configuration with valve 10 after implantation. The crown 20 is comprised of a series of subunits of the crown 21, each of which has an atraumatic tip 22 at the upper end, so that the entire crown 20 maintains a low profile defined by dimension F, so that no structure extends substantially to the right atrium. A plurality of crown subunits 20 are comprised of crown struts 21 that define a space between the atraumatic tip 22 and the rest of the structural frame support 11 which is comprised of an opening that can be traversed and engaged by release wires (see Figures 8A to 8C and 9 below). The maximum heights for the crown 20 above the atrial skirt 19 are described in Table I.
[080] In the lower / inferror or ventricular portion
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50/77 of the stent assembly with valve 10, the ventricular teeth 18 are integrally formed with a lower connector 17 that joins the individual struts 13 in the distal or ventricular portion of the structural frame support 11. The lower connector 17 can have openings 16 that they pass through the body of the lower connector 17 and may receive sutures or other fixation structures (not shown). The ventricular teeth 18 are preferably linear barbs attached to the lower connector 17 and which are implanted radially to extend away from the lower connector 17 when the stent with valve 10 expands from the retracted configuration to the expanded configuration at the time of implantation. Each ventricular tooth acts as a second tissue engaging structure that extends away from the stent structural frame number 11 to engage native valve ring tissue to anchor valve stent assembly 10 in place.
[081] Preferably, a plurality of ventricular teeth 18 is formed from an equal plurality of lower connectors 17 to form a matrix of ventricular teeth 18 that perform the gripping function that anchors and secures the valve stent assembly to the portion ventricular valve ring after implantation. The combination of the atrial teeth that form the annular atrial skirt 19 and the ventricular teeth 18 form a pair of
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51/77 structures that engage the tissue that engage two regions of tissue close to the native ring and perform the gripping function in two directions that are annular in a configuration at least partially opposite to secure and anchor the stent with valve 10. The gap between the tooth tips 18 and the outer circumferential surface of the valve stent and the underside of the annular atrial skirt form a thread-shaped toroidal cavity that will be filled with native leaflets and annular tissue while holding the stent assembly with valve 10 so that the valve stent establishes a fluid-tight interface of the atrium and ventricle, which thus provides both the interchamber seal and prevents migration.
[082] As described above, the relative dimensions of valve stent assembly 10 establish a low profile configuration that has a large valve tissue diameter in relation to the height dimension to produce superior fluid dynamics as blood flows through the structural frame support body 11 when the valve mechanism (not shown) is arranged thereon. As shown in Figure 5B, several dimensions are defined to specify the dimensions, range of dimensions and ratio or proportion of dimensions that provide the superior fluid dynamics for a particular valve prosthesis, in this case, a stent assembly with a chosen valve 10
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52/77 for a patient whose native ring requires a 48 mm replacement valve.
[083] As described below, many relative dimensions of stent assembly with valve 10 are aspects of the present invention and produce the unique dimensional profile and superior hemodynamics, however, the general diameter of the valve prosthesis is determined by the pathology of the individual disease of the patient. For each patient, a total valve size or annular tissue diameter (TAD) is obtained by imaging Computer Tomographic Angiography (CT Scan) and Transesophageal Echocardiography (TEE) or real-time three-dimensional echocardiography (RT3DE) obtained from the patient. The severity of the dysfunctional valve is analyzed in the area and perimeter of the obtained ring from which the dimension of the ring is obtained. This diameter corresponds to the ventricular, distal diameter closest or largest to the valve stent. Tissue diameter sizes of tissue that are within the different diameters provided for individual valve stent sizes of the invention are best adjusted for the next lower size of the valve stent, thereby preventing oversizing that affects the sinus of the aortic valve and affects the heart's electrical conduction system which leads to potential arrhythmias or heart block. A ring size on the patient who has a sick native valve. The diameter of
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53/77 inflow B defines the atrial opening or orifice for blood flow through valve stent assembly 10. The diameter of the crown C is the inner diameter of the annular atrial skirt 19. The total height D is the sum of the ventricular fundus to the annular atrial ring 19 plus crown height F20.
[084] Additionally, due to the height of the fabric component comprised of valve leaflets, for example, valve leaflets 26a, 26b, 26c of Figure 6A being substantially equal to the total height of dimension D, dimension D also provides a measure of the total height of the tissue component of the valve leaflets. As noted above, because the entire diameter of the valve stent assembly 10 is comprised of the tissue component of the valve element, the diameters, dimensions A and dimensions B also correspond to the total diameter of the tissue component of the valve stent assembly 10 The height H of the ventricular tooth 18 is from the bottom of the ventricular ring to the tip of the ventricular tooth 18 as it extends away from the lower connector 17. Dimension H thus defines the height of the projecting engagement structure from the ventricular portion of the valve stent assembly 10. As noted above, together with the atrial crown 20, which has a height F above the atrial teeth 19, the atrial crown 20 and the ventricular teeth 18 perform a paired gripping function
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54/77 in the tissue on both the atrial and ventricular side of the native valve ring.
[085] Dimension I is the distance between the atrium-oriented tissue engaging means and the ventricle-oriented tissue engaging means and provides a capture dimension that valve stent 10 uses to wrap the leaflet mass native and engage the native ring. Dimension I varies between 5.5 mm and 9 mm and is preferably between 5.5 to 8 mm for mitral valve prostheses and between 6.5 to 9 mm for tricuspid valve prostheses and is substantially approximately 7 to 8 mm for tricuspid valve prostheses. In the embodiment of Figures 5A and 5C, dimension I is a distance between the annular atrial skirt 19 and a plane formed by the highest tip of the plurality of ventricular teeth 18. Consequently, the distance of dimension I can be measured between the plane of the portion annular atrial skirt 19 and the average distance from the upper tip of the ventricular teeth 18 considered to be positioned in a single plane. As noted in this document, dimension I preferably ranges from 5.5 mm to 9 mm with a range of 5.5 to 8 for a mitral valve prosthesis and 6.5 to 9.0 for a tricuspid valve prosthesis.
[086] These relative and absolute distances, dimensions and proportions can be summarized as follows for
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55/77 supports with valve that have dimensions A of 36, 40, 44, 48 and 52 mm:
TABLE 1
Size ofStent THE B Ç D AND F G H I A / D B / D 36 36 3020.955 15.9 5.1 2 7,9 7 a8 1.718 1.431 40 40 3018.796 15.9 2.9 2 7,9 7 a8 2.128 1.596 44 44 3319.431 15.9 3.5 3 2 7,9 7 a8 2.264 1.698 48 48 35.0 51 38.6 28 22.5 8 16, 341 6.2 4 1.75 9,6 7 a8 2.125 1.5 5 52 52 41.520.955 17 3.96 3.1 5 9 7 a8 2.481 1.98
[087] The valve stent 10 of the invention can be manufactured to have predetermined diameters of any size, but is conveniently offered in sizes between 36 mm and 52 mm and as large as about 64 mm, while maintaining the limitations of height and proportions relative to each other, as described in Table I. To achieve the benefits of the low profile design, the stent assembly with valve 10 has a total height of less than 25 mm and typically between 10 and 22 mm, consistent with the geometry and dimensions pre -determined, as described in this document. As is apparent from the values in table I, the ratio between the dimensions of the atrial or inflow orifice, dimension B, and the size of the ventricular or efflux orifice A, is between 0.60 to 0.90 and preferably
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56/77 between 0.70 to 0.85. Modalities of the invention that have relative proportions of 0.75 can be used as a guide to manufacture valves with the dimensions described in this document for any diameter dimension A between 30 mm and height up to 70 mm, consistent with the other design parameters and dimensional limitations, as described in this document. In addition to the specific quantitative values in Table I, all incremental values between them are included in the disclosure of this invention, along with percentage proportional ratios of the items above, differing from the values presented by 95%, 90%, 85%, 80%, and 75%, consistent with the general teachings of the invention. In a particularly preferred embodiment, the valve stent assembly has a predetermined diameter dimension A between 36 and 54 mm, the ratio between dimension B and dimension A is between 0.70 and 0.85, the total height dimension D is less than 0.25 mm, and the dimension of I which comprises the gap between the upper and lower fabric engaging structures is between 5.5 mm and 9 mm.
[088] With reference to Figure 5C, the relative angles of the ventricular tooth length 18 are shown in relation to the adjacent elements of the structural frame support 11. The angle of the degree of inclination of the total height of the device is shown as 19 °. The taper
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57/77 total is preferably less than 20 ° and greater than I ^o , so that the overall dimension of the supporting structure is non-cylindrical and has a limited degree of taper along the entire height dimension D.
[089] Figures 6A to 6B are seen in top and side perspective of the stent assembly with valve 10, with gripping means to fix and stabilize the heart valve apparatus in the valve ring. As noted above, the valve apparatus of the invention comprises a fabric valve 25 attached to the structural frame support 11 and which has leaflets 26a, 26b 26c. The leaflets substantially comprise the entire diameter of the structural stent frame along the entire height of dimension E in Figure 5A above, without depending on an additional support structure or fixing ring inside or outside the structural frame support 11. Consequently, the structural frame of the stent is attached directly to the native valve tissue around the outer surface and to the tissue component of the valve prosthesis in the inner circumference without additional material. This configuration maximizes the working diameter of the valve prosthesis, while maintaining a low profile for the overall height dimension D of the stent assembly with valve 10.
[090] In a particular modality, the support structure additionally comprises structures that
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58/77 grasp the tissue close to the native valve ring and, in the exemplary embodiment of Figure 5A, are the means for gripping the crown 20 and the atrial teeth 19 to fix and stabilize the heart valve apparatus in the native valve ring. The important elements of the gripping function are provided by structures that are spaced along the body of the gripping means comprising a plural pair of separate lower and upper tissue latch located on the upper atrial outer circumferential and lower outer ventricular surface of the structural frame of the stent 11 and switably configurable to form a receptacle generally in the form of J or U or C (outward) to receive and maintain the ring.
[091] In an additional embodiment, the stent surface portion 24 of the C 23-shaped receptacle is uniformly coated with a certain tissue material. The lining material of the internal surface of the stent serves to support the internal pericardial wall of the valve stent and to seal the space between the atrial teeth and the area close to the external surface of the valve stent 10 and the edge of the native valve ring for prevent blood infiltration or improve local blood clotting, while maintaining the separation of both the upper (atrial) and lower (ventricle) chambers of the heart. The coating material is generally hydrophilic and can
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59/77 be selected from a group consisting of weaving microfibers from esters of ethylene polymers, silicone, polyurethane, hydrogel, cloth and other polymers.
[092] The gripping function is preferably achieved when the atrial teeth 19 extend to an axially straight position (a first position) that is substantially perpendicular to the geometric axis of blood flow through valve 25. Because the atrial teeth 19 are crimped inside the catheter capsule distal when the valve apparatus is in the retracted configuration during the delivery stage. As the valve stent is released to fully implant from capsule 50 (see Figures 8 and 11), the atrial teeth 19 that form the annular skirt rotate approximately 90 ° to reach the configuration that extends radially and engages the side of the native valve ring as shown in Figure 7A.
[093] The generally radial implantation of ventricular teeth can be aided by exposure to the second temperature, that is, to normal body or blood temperature. The angle of the ventricular element that pivots outward from the external surface of the stent can be approximately 39 ° to approximately 44 °.
[094] In implantation, the ventricular teeth 18 of the atrial skirt 19 exert paired gripping forces
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60/77 in the annular tissue of the native valve ring to anchor the stent with valve 10 in place, engaging the ring in two positions and in two different directions. As described below, this implantation or performance of the atrial skirt 19 and ventricular teeth 18 can be distinct steps in an implantation method of the invention that promotes precise and controlled positioning of the stent with valve 10 in the target dysfunctional native ring. In one embodiment, the first temperature is between about 1 and 35 ° C, preferably between about 4 and 20 ° C. In another embodiment, the second temperature is between about 20 and 45 ° C, preferably between 35 and 40 ° C.
[095] With reference to Figures 7A and 7B, a valve stent embodiment of the present invention is seated on the native valve ring, which shows, for example, the general position of the valve stent 10 in relation to the valve ring and the tendon cords 40 which, in turn, are connected to the wall of the ventricle 41. In the left panel of Figure 7A, the stent with valve 10 is shown in the expanded position and to show the dimensioning in relation to the native valve ring. As noted herein, the valve stent 10 of the present invention is chosen according to a measurement of the size of the dysfunctional valve on the patient and matched in size. In the right panel of Figure 7 A, the stent with
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61/77 valve 10 is shown after the replacement of the dysfunctional valve. In this example, the atrial skirt 19 engages the bottom of the right atrium while the ventricular teeth 18 engage the ventricular side of the native ring, so that the tendinous cords are between the adjacent ventricular teeth.
[096] As seated on the native ring, the stent with valve 10 has a minimal upper profile that extends to the atrium to provide superior hemodynamics and minimize the potential for damage in contact between the bioprosthesis and the atrium walls during contraction. The only structure extending above the atrial skirt 19 is the tip of the crown 20, which has an inverted V shape and is comprised of the upper portion of the diamond-shaped strut 13 following expansion. The uppermost structure of the valve is the atraumatic tip 22 which defines the height of the crown 20 above the annular atrial skirt 19. As noted above, fixation to the native ring occurs both at the upper, atrial, that is, proximal to the portion of blood flow of the bioprosthesis, due to the first tissue engagement structure, in this example the annular atrial skirt 19, as well as the lower ventricular skirt, that is, distal in relation to the blood flow due to the second tissue engagement structure, in this case example the ventricular teeth. Through this configuration, the
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62/77 gripping the stent with valve 10 in the native ring is facilitated by both tissue engagement structures, one that has atrial positioning in one that has ventricular positioning and that has a different height (defined as dimension I above) that hold the native valve leaflets and seal the stent with valve 10 against the native ring. Consequently, the secure engagement of the stent with valve 10 in the native ring is facilitated by the conical dimension of the structural frame support 11, the upper / atrial and lower / ventricular fixation structures of the device and the general dimensioning of the device to fit securely inside. native ring and to be anchored at the destination.
[097] Referring to Figure 7B, a detailed view of the stent fixation with valve 10 on the native ring shows an engagement close to the annular atrial skirt 19 and the positioning of the tendinous cords between the ventricular teeth 18. A single subunit of the frame support structural 11 is shown with a diamond-shaped structure formed by the individual struts 13 that end at the upper connector 15 and the lower connector 17. The implantation of the ventricular tooth is shown passing between the tendinous cords to engage the ventricular aspect of the native ring.
[098] With reference to Figures 8A to 8C, the
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63 / dist distal end of a delivery system 39 is shown with portions of the structural frame support 11 provided to demonstrate engagement of the structural frame support 11 with the release mechanism at the distal end of the delivery system. The steerable catheter 40 is comprised of a hollow lumen 44 that terminates at a distal catheter connector 41 that is traversed by a pair of alignment pins 43. Although the embodiment of Figure 8A illustrates a pair of alignment pins 43, any number of pins is provided as long as a guidance function is provided. A pair of alignment pins 43 allows deflection of the distal end of the directional catheter 40 and a single plane and the ability to rotate the orientable catheter 40 allows the operator to change the axial arrangement of the distal end of the delivery system to orient the stent with valve 10 to approach the native ring plane perpendicularly. A port 42 that provides fluid communication is coupled to a fluid conduit (not shown) that runs the length of the lumen 44 of the directional catheter 40. The delivery system as the capsule 50 that is positioned intermediate to the distal connector 41 and the tapered tip 55. During delivery of the valve stent, the valve stent is contained in the retracted configuration inside the capsule 50 to the distal end of the delivery system
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64/77 approach the destination. The valve stent is held in place by the tapered tip which is capable of axial movement in relation to the targetable catheter 40 by manipulation of a foldable hypotube 51 that passes through the lumen 44 of the targetable catheter 40 and can be manipulated by the user as described in connection with a Figure 10. The wire 51 passes through the valve stent passing through the leaflets and is formed integrally with the conical tip 55 by connection at a fixation point 54. The conical tip 55 has a blunt distal end 53 which is atraumatic according to the end distal delivery system 39 crosses the vasculature to position the valve stent at the destination site. In the example in Figure 8A, the valve would be partially implanted with the support of structural frame 11 in a partially expanded configuration with the ventricular portion and the ventricular teeth 18 advancing towards the expanded configuration while the atrial portion including the atrial skirt 19 is at less partially retracted and can be kept within the body of the capsule 50.
[099] Referring to Figure 8B, the fixation / release mechanism for the valve stent is illustrated by a single member of the structural frame support 11 that has release wires 56 wrapped around the crown of the valve stent and that engage the flap holder 69 for
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65/77 maintain the retracted configuration of the atrial portion of the valve stent, while secure placement at the destination site is guaranteed. The capsule 50 is removed axially and proximally in relation to the valve stent to expose the flap support 60 and the locking wires 56 which are located at the most distal point of the lumen 44 of the directional catheter 40.
[100] With reference to Figure 8C, the distal end of the directional delivery catheter 40 is shown with four loops formed of release wires 56 that cross the crown 20 of the valve stent. Each release wire 56 engages the flap 68 at the distal end of the delivery catheter 40. Each release wire 56 can be manipulated by the surgeon to loosen the engagement of the release wire 56 six on the flap holder 67 to allow the release wires 56 come off the flap 68. As the release wires 56 disengage from the flap 68, the release wire 56 can be pulled through the crown 20 of the valve stent to release the valve stent from the distal end of the targetable delivery catheter 40 In the embodiment of Figure 8C, four wire loops engage the valve stent 10 in relative positions of 90 ° around the crown 20. Although the number of points of engagement by the release wires 56 with the crown 20 of the valve stent does not be critical, at least four engagement points with crown 20 are preferred
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66 / ΊΊ to increase the ability to control the implantation of valve stent 10 by manipulating the release wires 56. The flap support 60 has an outer circumferential surface 69 that maintains a close engagement with the inner surface of the delivery catheter lumen 44. The close engagement between the outer circumference of the flap support 60 and the lumen 44 of the directional catheter 40 ensures that the flap support remains concentrically oriented with the distal opening of the directional delivery catheter 40 for precise positioning of the valve stent 10. The actuation of the release wires 56 occurs after the cap 50 is removed proximally to allow the release wires 56 to come off the flap 68. The release wires 56 pass through the body of the flap support 60 through dedicated wire openings, such as described below in relation to Figure 9. The diameter of the conical tip 52 is necessarily smaller than the diameter of the ventricular portion of the stent with valve 10, so that, in following the release of the release wires 56, the stent with valve 10 can be implanted and the conical tip 52 removed in the proximal direction through the interior of the stent with valve 10 towards the flap support 60. The conical tip 52 preferably has a curved exterior 55 that is tapered along a length to allow the atraumatic crossing of the structure through the valve stent leaflets 10.
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67/77
[101] Referring to Figures 9A to 9B, Figure 9A shows the underside of the flap support 60 at the distal end of the delivery system and shows how the release wires 56 are oriented around the central geometric axis of the collapsible hypotube 51 and the clearance of ports 61 for release wires 56 away from the attachment points for alignment pins 43. Figure 9B also shows the tabs 68 that engage release wires 56 until loosened to implant the stent with valve 10. O The flap support body 60 is traversed by the release wire ports 61 and has fixing accessories 65 for fixing the alignment pins 43. The central port 63 is crossed by the folding hypotube 51 which is connected to the conical tip 52. The proximal side the flap support 60 has a lowered portion 62 to provide a release mechanism that allows implantation of control of the stent with valve 10, so that the expansion of the retracted to the expanded configuration can be taken care of controlled by the surgeon.
[102] The delivery system is comprised of the distal tip assembly, the steerable catheter and a cable assembly that houses controls for the capsule 50, the conical tip 52, the alignment pins 43 and the release wires 56. The Figure 10 shows the entire delivery system, which includes proximal controls, which allow
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68/77 handling of the targetable delivery catheter 40. As described above, the conical tip 52 and the cap 50 containing the valve stent in the retracted configuration (not shown) are located at the distal end of the entire delivery system and are connected to the manual controls by the directional catheter. The manual controls are contained in a multifunctional cable 71 that contains a discharge port 70 and a control to direct the directional catheter 40 by rotation of an accessory that provides relative movement of the alignment pins 43. In the two-pin mode, the shortening of any pin directs the tapered tip towards the shortened pin and allows deflection of the tapered tip 52 by at least 90 °. The cable preferably also has controls for axial movement of the capsule 59. For example, the rotation of a capital control button 73 pulls the capsule 50 proximally to facilitate implantation of the valve stent. Separately, the control cable 71 has an accessory to control the release wires 56. For example, a button that is rotatable around the geometric axis of the cable 71 loosens the release wires 56 to allow implantation of the valve stent.
[103] With reference to Figures 11A and 11B, the relative orientation of the capsule 50, the hypotube 51, the alignment pins 43 and the release wires 56 illustrate how the
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69 / ΊΊ capsule can be targeted using alignment pins, while maintaining the ability to pull capsule 50 proximally to implant the valve stent (not shown). As described above in relation to the alignment pins 43, shortening the length of one alignment pin 43 in relation to the others causes the deflection of the capsule and the ability to direct the capsule 50 containing the stent with valve for implantation. As can be seen from the configuration of the delivery system, it is possible to deflect the capsule 50 without changing the functionality of the intubator 51 and intact for the capsule 50, so that the capsule 50 can be removed without affecting the orientation of the capsule in in relation to the axial length of the targetable catheter 40, nor affect the tension maintained in the release wires 56. Consequently, the capsule 50 can be partially removed to implant the ventricular teeth 18, while the release wires 56 retain the fixation of the atrial end of the stent with valve to the flap support 60 by means of the release wires 56. In this configuration, the separate movement of the capsule 50 and the action of the release wires 56 provide a separate implantation of the ventricular teeth of the annular atrial skirt 19. The result of this configuration is that valve stent 10 can be implanted gradually, so that the second tissue engaging structure,
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70/77 ventricle 18 can first be implanted into the ventricle portion of the native ring to position the teeth of ventricle 18 between the native tendinous cords thereby ensuring secure engagement of the ventricular end of the stent with the valve, while the atrial end of the valve stent remains captured by the release wires 56. Once the proper positioning of the ventricle teeth 18 is ensured, the general configuration of the valve stent 10 and the atrial crown still at least partially retracted 20 is ensured, the atrial portion of the stent with valve 10 can be released separately to complete the implantation.
[104] General delivery methods for catheter-based valve devices are known in the art. The previous description needs to be considered as modifications of procedures that are generally known. A catheter apparatus for delivering heart valve bioprostheses and their use are well known to those of skill in the art. For example, Tu et al. in US Patent No. 6,682,558, the content of which is incorporated in full into this document for reference, discloses a catheter and a method for delivering a bioprosthesis without a stent in a body channel, the method of which involves the percutaneous introduction of a catheter in the body channel, where the catheter contains the bioprosthesis without a stent in a
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71/77 retracted; and disengaging the bioprosthesis without a stent from a distal catheter opening by a traction mechanism associated with the catheter structure.
[105] Consequently, due to the unique design, the stent with valve 10 is kept inside the cylindrical housing of the capsule 50 until the distal or ventricular end of the stent with valve 10 begins to emerge from the capsule and so that the lower or ventricular teeth are implanted radially to an external position (a second position) away from the external circumferential surface of the valve stent 10. The implantation of the valve stent 10 of the delivery system can be achieved through several modalities that allow or cause the stent with valve 10 expands from the retracted to the expanded configuration. The general profile of the valve stent 10 can be restricted by containing the valve stent 10 within the hollow portion of a housing, such as a lumen 44 preformed at the distal end of a delivery catheter 40. The distal end of the catheter delivery unit 40 can be a simple hollow space or compartment for containing the stent with retracted valve 10 or it can be formed by a variety of other structures to facilitate the implantation step. In a well-known manner with other implantable medical devices, the valve stent 10 can be pushed from the end
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72/77 distal from the delivery catheter by a rod or other mechanical device that is advanced against the structural frame support 11 of the stent with valve 10. Alternatively, a mandrel can hold the stent assembly 10 in place while the outer lumen is retracted along the length of the stent with valve 10 to allow its expansion.
[106] In a preferred embodiment, the delivery system, as described in Figure 10, is provided with a targetable delivery catheter 40, comprised of: a catheter with a lumen 44 comprised of a braided Pebax tube and a PTFE coating and may have an external diameter less than approximately 24 Fe, a length of at least 41 cm, a distal directional region comprised by the capsule 50 and the conical tip 52 and capable of directional control and a deflection angle of at least 75 ° and preferably 90 ° or more by manipulating a steering mechanism. The steering mechanism can comprise any mechanical device that is operable from the delivery system cable and directs the distal end of the delivery catheter 40. In the embodiment of Figures 8 and 11, the steering mechanism comprised by the alignment pins 43. However, alignment pins 43 can be replaced with a guide wire or the like to reduce the diameter
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73/77 overall of the capsule element restricted by the required diameter dimension A of the stent with valve 10. The length of the steerable region is approximately 25 mm. A stainless steel cable (not shown) can be embedded in the 40-directional catheter for navigation control. The controlled release wires 56 are preferably produced from PTFE-coated Nitinol and allow controlled release of the valve stent. The combination of the fixing flap 68 in the flap support 60 forms a release mechanism consisting of the releasable fixation of the crown 20 or the wing subunits 21 that have an opening in them that is crossed by the release wires 56. Consequently, the release 56 run the length of the directional catheter 40 from the control mechanism 74 through the lumen 40, which crosses the wing subunits 21 of the crown 20 and engages the flap support 60 on the flap 68 of the flap support 60. Simply loosen the release wires 56, increasing its length, releases the distal end of the release wires 56 of flap 68 and releases the atrial portion of the stent with valve 10, once the surgeon has confirmed that the stent with valve 10 is correctly positioned.
[107] The delivery system cable 71 consists of the following: a direction control button 72 for directional navigation of the distal end of the catheter
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74/77 steerable 40. The steering control has a torque limiter to prevent damage due to the potential for over steering. A capsule control button 73 controls the initial partial release of the ventricular portion of the valve stent by retraction of the capsule 50, thereby causing at least partial expansion of the ventricular aspect of the valve stent 10 according to the length of the frame support structural 11 is exposed when the capsule 50 retracts. The cable additionally comprises a control mechanism for the release wires 56 that loosens the release wires for controlled implantation of the atrial portion of the stent with valve 10 and, finally, final release of the entire prosthesis at the destination site. A safety pin (not shown) can be added to the release wire control mechanism to prevent unintentional release of the valve with distal end valve from the delivery catheter 40.
[108] Echo and fluoroscopic imaging is used for navigation and any structural feature of the valve stent 10 or the distal portion of the delivery system may have an element added for imaging detection. The distal end of the delivery device can be guided to a desired configuration in the native dysfunctional ring, by rotation of the direction control knob and by rotation of the entire cable 71. Gradually, the stent implantation
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75/77 with valve 10 is achieved by first advancing the conical tip 53 a short distance from the dysfunctional native valve under fluoroscopy. Then, the capsule control mechanism 73 is activated, for example, by clockwise rotation of a button. A safety feature can fix the position of the capsule after an initial release of the ventricular portion of the valve stent 10 by locking the capsule control mechanism 73 in place to prevent further rotation and axial movement of the route 50 capsule relative to the geometric axis directional catheter 40. This retracts the capsule and exposes the ventricular or efflux aspect of the implant. At that point, the distal ventricular efflux aspect of valve stent 10 is in a substantially open configuration, while the proximal atrial inflow portion of valve 10 stent is restricted, for example, to a diameter substantially equal to the size of the inflow diameter B maintaining the tension in the release cables 56. Final adjustments to the location of the stent with valve 10 inside the valve ring are performed and then the controlled release button 74 is rotated to advance the controlled release wires 56. This action slowly expands the atrial inflow portion of the valve stent until the crown 20 is fully expanded in the atrial skirt 19 and rotates approximately 90 ° to the fully expanded configuration. Maneuvers
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Additional 76/77 of the valve stent can be performed by gently pushing or pulling the delivery system to ensure that the valve stent is seated in the appropriate position within the tricuspid ring.
[109] Then, a safety pin is pulled during the simultaneous counterclockwise rotation of the capsule control mechanism button 73, which additionally retracts capsule 50. Then, the release wire control mechanism 74 is actuated, such as by counterclockwise rotation, to retract the release wires 56 back to the lumen 44 of the delivery system catheter 40. The conical tip 52 is retracted by pulling the wire 51, as by retraction of the proximal portion 76 of the guide wire, as if it extends proximally to the cable at a fixation point. A Tuohy Borst 75 adapter is fastened to the guidewire catheter 51 which locks the tapered tip 52 in a retracted position. At that point, the catheter of delivery system 40 can be safely removed.
[110] In a preferred embodiment, the stent with valve 10 is stored in an expanded configuration and then loaded by compression into the delivery catheter 40 immediately before use, reducing the temperature of the stent with valve 10, as described above. The compression loading system can be comprised of the following components: a
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77/77 stent with valve and ice bath; a compression cone preferably made of Ultem; a transfer capsule - preferably made from Ultem; a pressure tool - preferably made of Ultem; a balloon conforming to the syringe.

权利要求:
Claims (15)
[1]
1. Bioprosthetic atrioventricular valve, characterized by the fact that it comprises:
a valve stent assembly comprising an expandable structural frame support from a retracted to an expanded shape and which has an atrial inflow orifice and a ventricular efflux orifice and a tapered dimension along the height of the structural frame support in which the atrial inflow orifice has a smaller diameter than the ventricular or efflux orifice;
a layer of pre-cut mesh that covers the inner surface of the structural frame support from the atrial inflow orifice to the ventricular efflux orifice;
a fabric valve that has at least two leaflets and affixed around the inner surface of the structural frame support and that has a height and diameter approximately equal to the height and diameter of the structural frame support; and a first fabric engaging structure that extends from a portion of the structural support frame near the atrial inflow orifice and a second fabric engaging structure that extends from a portion of the structural frame support near the ventricular efflux orifice to grasp the
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[2]
2/6 tissue in both the atrial and ventricular aspect of the native valve ring.
2. Bioprosthetic atrioventricular valve, according to claim 1, characterized by the fact that the first fabric engaging structure is in the annular atrial skirt that extends radially from the structural frame support at an angle between 85 and 95 °.
[3]
3. Bioprosthetic atrioventricular valve according to claim 1, characterized in that the second tissue engaging structure is a plurality of ventricular teeth that extend radially away from a plurality of connectors located circumferentially around the ventricular orifice efflux.
[4]
4. Bioprosthetic atrioventricular valve according to claim 1, characterized by the fact that the distance between the first tissue engaging structure and the second tissue engaging structure is between 5.5 and 9.0 mm.
[5]
5. Bioprosthetic atrioventricular valve according to claim 4, characterized by the fact that the distance between the first tissue engaging structure and the second tissue engaging structure is between 7.0 and 8.0 mm.
[6]
6. Bioprosthetic atrioventricular valve, according to
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3/6 with claim 1, characterized by the fact that the total height of the structural frame support is less than 25 mm.
[7]
7. Bioprosthetic atrioventricular valve according to claim 6, characterized by the fact that the ratio of the atrial inflow orifice diameter to the ventricular efflux orifice is between approximately 0.60 and approximately 0.90.
[8]
8. Bioprosthetic atrioventricular valve according to claim 7, characterized by the fact that the ratio of the diameter of the atrial inflow orifice to the ventricular efflux orifice is between approximately 0.70 and approximately 0.85.
[9]
9. Bioprosthetic atrioventricular valve, according to claim 1, characterized by the fact that the diameter of the ventricular or efflux orifice is greater than 30 mm.
[10]
10. Bioprosthetic atrioventricular valve according to claim 1, characterized by the fact that the first portion of the fabric engagement is covered with a layer of mesh that covers a portion of its annular structure, which comprises an upper surface, a lower surface or combinations thereof.
[11]
11. Bioprosthetic valve delivery system, characterized by the fact that it comprises:
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4/6 a capsule located at the distal end of a targetable catheter and containing the bioprosthetic atrioventricular valve, as defined in claim 1, a tapered tip distal to the capsule and affixed to a thread running through the tissue valve and the length of the targetable catheter a plurality of release wires that span the length of the targetable catheter and that span a bioprosthetic atrioventricular valve crown, as defined in claim 1 to maintain the bioprosthetic atrioventricular valve, as defined in claim 1, in a retracted configuration, a proximal cable which contains control mechanisms for each one to direct the distal end of the directional catheter, slide the capsule axially to implant the bioprosthetic valve, as defined in claim 1, and control the tension in the plurality of release wires.
[12]
12. Bioprosthetic valve delivery system, according to claim 11, characterized by the fact that the release wires pass through a flap support located near the distal end of the addressable catheter and form a loop to engage a flap fixation in the support flap.
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5/6
12. Bioprosthetic valve delivery system, according to claim 11, characterized by the fact that the proximal cable additionally comprises a discharge port that has a fluid communication passage that passes through the directional catheter and ends near the capsule containing the retracted bioprosthetic valve as defined in claim 1.
[13]
13. Bioprosthetic delivery system, according to claim 11, characterized by the fact that it additionally comprises alignment pins that pass through the addressable catheter and are attached to the capsule so that the selective orientation of the alignment pins directs the distal end of the system Of delivery.
[14]
14. Bioprosthetic delivery system, according to claim 11, characterized by the fact that the bioprosthetic valve has a total height of the structural frame support that is less than 25 mm, a ratio of the diameter of the atrial inflow orifice in relation to the ventricular outflow orifice is between approximately 0, 60 and approximately 0.90, and a diameter of the ventricular or outflow is greater than 30 mm.
[15]
15. Bioprosthetic delivery system, according to claim 11, characterized by the fact that the proximal cable, the directional catheter, the tissue valve, the capsule are traversed by a catheter guidewire
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6/6 connected to the distal conical tip.

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法律状态:
2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201762505964P| true| 2017-05-14|2017-05-14|

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US62/505,964|2017-05-14|

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PCT/US2018/032615|WO2018213209A1|2017-05-14|2018-05-14|Valved stent for orthotopic replacement of dysfunctional cardiac valve and delivery system|

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