Stent-valves for valve replacement and associated methods and systems for surgery
Abstract
This record has no abstract on file.
Term
0.9 yearsto projected expiry
Projected expiry 23 August 2027, counted from filing; an application has no term until it is granted.
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13 claims: 7 independent, 6 dependent
- 1Zastrzeżenia patentowe 1. Zastawka do użycia w ciele ludzkim zawierająca:- element zastawki (100);oraz - element stentu (800, 900, 1000) zawierającego: pierwszą sekcję (802), drugą sekcję (804) do umieszczania elementu zastawki (100) oraz trzecią sekcji (806), przy czym trzecia sekcja (806) zawiera co najmniej jeden element mocujący (808, 814, 836, 902, 1002) skonfigurowany do rozłącznego mocowania do urządzenia wprowadzającego (2300, 2400, 2500, 2600) znamienna tym, że element stentu (800, 900, 1000) kratownicową, w której pierwsza sekcja liczbę komórek niż druga sekcja (804) obejmuje strukturę (802) posiada większą i/lub trzecia sekcja (806).
- 2Zastawka według zastrzeżenia 1, w której co najmniej jeden element mocujący (808, 814, 836, 902, 1002) zawiera otwór geometryczny skonfigurowany do rozłącznego mocowania do elementu dopełniającego urządzenia wprowadzającego (2300, 2400, 2500, 2600).
- 3Zastawka według jednego z poprzednich zastrzeżeń, w której co najmniej jeden element mocujący (808, 814, 836, 902, 1002) zawiera drut, haczyk lub taśmę skonfigurowaną do rozłącznego mocowania do elementu dopełniającego urządzenia wprowadzającego (2300, 2400, 2500, 2600).
- 4Zastawka według jednego z poprzednich zastrzeżeń, w której co najmniej jeden element mocujący (808, 814, 836, 902, 1002) zawiera co najmniej dwa, a korzystnie trzy lub sześć elementów mocujących (808, 814, 836, 902, 1002).
- 5Zastawka według zastrzeżenia 1, w której pierwsza sekcja (802) obejmuje wiele niezależnie zginalnych elementów (816), przy czym każdy ze zginalnych elementów (816) obejmuje jedną, zamkniętą komórkę spośród komórek kratownicy z pierwszej sekcji (802).
- 6Zastawka według zastrzeżenia 1, w której trzecia sekcja (806) zawiera elementy klamrowe (1004), które łącznie tworzą okrąg wokół elementu stentu (1000).
- 7Zastawka według zastrzeżenia 1, w której struktura kratownicowa elementu stentu zawiera:- co najmniej jeden słupek spoidłowego;oraz - co najmniej jeden element podpierający do połączenia co najmniej jednego słupka spoidłowego z co najmniej jednym elementem mocującym (808, 814, 836, 902, 1002).
- 8Zastawka według jednego z poprzednich zastrzeżeń, w której co najmniej jeden element mocujący (808, 814, 836, 902, 1002) wystaje co najmniej częściowo w kierunku centralnej osi elementu stentu (200, 800).
- 9Zastawka według jednego z poprzednich zastrzeżeń, w której trzecia sekcja (806) ma średnicę mniejszą niż średnica drugiej sekcji (804).
- 10Zastawka według zastrzeżenia 5, w której pierwsza sekcja (802) zawiera element mocujący, któryzawiera pierścieniowy rowek.
- 11Zastawka według zastrzeżenia 10, w której pierścieniowy rowek tworzy wiele niezależnie zginalnych elementów (816), przy czym każdy ze zginalnych elementów (816) tworzy zginalne odkształcenie, którego umiejscowienie określają długości (822) przyłączonej pary rozpórek (818, 820).
- 12Zastawka według jednego z poprzednich zastrzeżeń, w której element mocujący (808, 814, 836, 902, 1002) zawiar drut tworzący otwór, haczyk lub taśmę.
- 13Zastawka według jednego z poprzednich zastrzeżeń, w której druga sekcja (804) zawiera co najmniej jeden element blokujący wystający na zewnątrz z zewnętrznej powierzchni drugiej sekcji (804. FIG. 1A 100 FIG. 1B FIG. 2A FIG.4 FIG. 5A 502 FIG. 5B FIG. 6A 600-^ 800 FIG. 8B FIG. 8C FIG. 8D 818 FIG. 9A FIG. 9B FIG. 9C FIG. 10A FIG. 10B FIG. 17 1702 1704 FIG. 18 1802 FIG. 19 1906 1902 FIG. 20 FIG.21A FIG. 21B FIG. 21C FIG. 21D 2308 FIG. 24A FIG. 25A 2600 2602 FIG. 27 FIG. 28A αο o ω Ostateczne uwolnienie / zamknięcie urządzenia wprowadzającego DOKUMENTY PRZYTOCZONE W OPISIE Lista przytoczonych przez Zgłaszającego dokumentów została zamieszczona wyłącznie do informacji czytelnika i nie stanowi części składowej europejskiego dokumentu patentowego. Została ona zestawiona z największą starannością;EUP nie ponosi jednakże żadnej odpowiedzialności za ewentualne błędy lub braki. Literatura patentowa przytoczona w opisie • US 84318106 P [0001] • WO 2005070343 A1 [0003] • US 70092206 A [0001] • US 2004093060 A1 [0003] • US 2005137688 A1 [0003] Literatura niepatentowa przytoczona w opisie • Akins et al. Risk of Reoperative Valve Replacement for Failed Mitral and Aortic Bioprostheses. Ann Thorac Surg, 1998, vol. 65, 1545-52 [0003] • Weerasinghe et al. First Redo Heart Valve Replacement - A 10-Year Analysis. Circulation, 1999, vol. 99, 655-658 [0003] • Liang Ma et al. Double-crowned valved stents for off pump mitral valve replacement. European Journal of Cardio-Thoracic Surgery, 13 June 2005, vol. 28,194-199 [0084]
Independent claims13
121 paragraphs in 2 sections, as filed
Technical Field [0002] Embodiments of the present invention include stent valves and associated methods and systems for the surgical placement of these valves and their placement by minimally invasive surgery techniques.
Background Art [0003] Conventional heart valve replacement methods require a relatively large sternal incision ("sternotomy") or opening of the chest wall ("thoracotomy") to allow the surgeon to access the patient's heart. In addition, these methods require cardiac arrest and the use of extracorporeal circulation (i.e. use of the lung heart to oxygenate the patient's blood and maintain its circulation). Despite the invasiveness, these surgical methods are relatively safe for the first surgical intervention. However, tissue adhesions resulting from the first surgery may increase the risk (e.g. death) associated with subsequent valve replacement surgery. See Akins et al. "Risks of Reoperative Valve Replacement for Failed Mitral and Aortic Bioprostheses", Ann Thorac Surg
1998; 65: 1545-1552; and Weerasinghe I et al. "First Redo Heart Valve Replacement - A 10-Year Analysis", Edition 1999,99: 655658.
US 2005/137688 A1 discloses a device and method for transcutaneous heart valve replacement in a patient. The traditional method involves the percutaneous introduction of an artificial valve and a flexible anchor in a closed configuration near the heart valve; expansion of the anchor until a target configuration is obtained in which the anchor contacts the tissue at the first contact point; moving the anchor to the second contact point; and placing the anchor in the second contact point.
WO 2005/070343 A1 relates to a kit consisting of a cylindrical endoprosthesis equipped with a mounting frame, and elastically deformed relative to a configuration in which the implant is expanded and ready for operation, and a configuration in which the implant is assembled and suitable for implantation. In the basic configuration of the mounting frame, the implant is expanded and ready for operation. In addition, a flexible obturator is connected to the attachment frame, change between the remaining position and the release position in which it has been transversely tensioned in response to the flow flowing through the attachment frame. In addition, integrated means for centripetal compression of the attachment frame are described to assist in obtaining a stowed position. Document US 2004/093060 A1 relates to a prosthetic valve system intended to replace a defective natural valve consisting of an artificial valve supported and an artificial valve which can be essentially a major axis, the shape of which can block in which the transversely expanded clamping frame is stretched. If desired, one or more anchors may be used. The valve attachment frame, which provides full support for the valve ring, valve petals, and valve attachment points, is configured to allow it to be folded prior to percutaneous insertion, and to expand to allow contact with the anatomical natural valve ring when the system is properly positioned. The anchor after expansion connects to the wall from the inside of the wall and prevents the valve system from moving when placed in a specific place. The artificial valve system is compressible around the catheter. The outer shell prevents it from expanding. The catheter can be placed inside the lumen of the vessel in the patient's body, for example, inside the femoral artery and inserted into a specific place, such as the heart. After the outer casing has been removed, the artificial valve system expands so that the valve and valve frame expand within a defective natural valve, and the anchor connects to the wall from the inside.
[0004] Synthetic and biological valves are used in heart valve replacement procedures with varying results. Synthetic valves rarely fail, but require lifelong anticoagulation to prevent blood clots (thrombosis) inside and around the artificial valve. Biological valves do not require anticoagulation, but usually cease to function after 10-15 years. Therefore, to reduce the necessity and risk of re-replacement of damaged biological valves, traditionally such biological valve prostheses are implanted in patients who have less than 10-15 years of life remaining. Patients with the expected longer survival receive synthetic valves and anticoagulant therapy.
[0005] Attempts are being made to develop less invasive surgical methods to replace the heart valve. These methods, also referred to as percutaneous heart valve replacement therapies (PHVTs), use a catheter to introduce the implanted valve through the patient's vascular system. These tests have various disadvantages, including the inability to place the valve in the right place and the stability of the implanted valve inside the patient's body.
[0006] In view of the above, it would be desirable to develop improved methods, systems and devices for replacing heart valves.
Brief Description of the Invention [0007] Some of the embodiments disclosed in the present application relate to heart valve replacement systems, methods and devices. For example, these methods, systems and devices may be applicable to all types of heart valve replacement surgery, including damaged aortic valve replacement, bifid, tricuspid, and pulmonary valve. In some embodiments, the invention may facilitate the surgical approach when surgery is performed on a beating heart without having to open the chest and use extracorporeal circulation. This approach based on the technique of minimal surgical invasiveness can reduce the risk associated with the primary replacement of a damaged natural valve, as well as the risk associated with subsequent operations to replace damaged artificial valves (e.g. biological or synthetic).
[0008] Stent valves according to some embodiments disclosed in the application may include a valve and at least one stent. The valve may be biological or synthetic (e.g. mechanical) and / or may include any other suitable materials. The stent may consist of a first section (e.g., proximal section), a second section where the valve is located, and a third section (e.g. distal section). The stent and valve can be configured in two ways: configuration of the assembly (e.g. during insertion) and expansion configuration (e.g. after implantation).
[0009] In some embodiments, the first stent valve section may include a fastening element. Such a fastening element may comprise, for example, an annular groove for securing the stent valve at the implantation site. In the case where the stent valve consists of one stent ("unit valve"), the annular groove may be configured to receive the valve ring to be replaced. In the case where the stent valve consists of two stents ("dual-valve"), the annular groove of the first stent may be formed to engage the complementary annular protruding portion of the second stent (i.e., positioning stent). In turn, the second stent can be anchored, for example, at the implant site to the valve requiring replacement and / or to adjacent structures.
Alternatively or additionally, in some embodiments, the third section of the stent component may include at least one attachment element. Each stent valve attachment member may include, for example, a hole with a geometric shape (e.g., round or oval), a hook or band formed so that the attachment to the complementary structure of the insertion device is removable. In addition, each attachment element may correspond to all or part of the commissural point to which a commissure may be attached between two valve leaflets. The attachment means may allow a partial expansion of the stent valve within the patient's body while the valve remains attached to the delivery device. This allows the valve to return to the composite configuration and change the position of the valve in the patient's body in the event that full expansion of the valve could cause its incorrect positioning. Alternatively or additionally, this allows the valve to be folded and removed from the patient's body if the valve is found to be malfunctioning (e.g., it does not allow adequate blood flow). In some embodiments, the stent valve may include one attachment member. In other embodiments, the stent valve may include at least two, three, six, or other suitable number of fasteners. In some embodiments, the diameter of the fully expanded stent in the region of the attachment member (s) may be smaller than the diameter of the area in which the valve is located. This may reduce the risk of injury to the patient (e.g. aortic perforation) caused by fasteners and / or facilitate fastening of fasteners to the complementary structure of the inserter.
[0011] In some embodiments, the stent valve may include a lattice structure with a large number of cells. The truss structure may be constructed, for example, from shape memory alloys, e.g. nitinol or other suitable materials. The cell density of the lattice structure in the part of the stent component that includes the attachment element can be very high. This allows additional support for the fastening element and increases the stability of the stent valve. In some embodiments, the lattice structure forms at least one elongated core (e.g. commissural point) that widens distally along the stent member toward the at least one fastener. At least one core is directly connected to at least one fastening element. Alternatively, the truss structure may form at least one support element for connecting the at least one core to the at least one fastening element. In some embodiments, all the cells of the truss structure may be closed cells to facilitate the change of stent valve configuration from partially expanded to composite.
[0012] Still other disclosed embodiments in the present application relate to a valve replacement method. A stent valve is shown comprising a stent member with an annular groove, the stent valve being axially attached to the annular valve requiring replacement. In some embodiments, the stent valve may include connecting the valve component to the stent component.
Alternatively or additionally, the stent valve may include expanding the valve element within the stent component to form a friction attachment. In some embodiments, the stent valve may include attaching the valve component to the stent component through a fastening system consisting of a hook and loop (e.g., VELCRO®).
[0013] In other embodiments of the present invention, a valve replacement method is provided in which a first stent component comprising an annular component is implanted such that at least a portion of the first stent component is placed within the valve requiring replacement. The stent valve comprising the second stent component is positioned within the first stent component by attaching the complementary annular component of the second stent component to the annular component of the first stent component.
[0014] In yet other embodiments, a stent valve delivery system is provided. The first system shown consists of an outer sheath and a guide wire. The delivery system also consists of a second system comprising a stent holder configured to be removably attached to at least one stent valve attachment member. The stent valve may be located above the first wire guide wire. The first and second dd systems can be configured to relative movement relative to each other to change the closed position to the open position. In the closed position, the outer cover may include the stent valve still attached to the stent holder, which limits the expansion of the stent valve. In the open position, the outer cover does not limit the expansion of the stent valve, thanks to which the stent valve can detach from the holder and expand fully.
[0015] In some embodiments, the first and second arrangements may be configured to move from a closed position to a partially open position. In the partially open position, the stent valve may expand partially without detaching from the stent holder because the outer cover may still include at least one stent valve attachment member and stent holder. If the stent valve is in a partially open configuration, you can determine whether the stent valve will be positioned correctly when it expands fully. Alternatively or additionally, the functionality of the stent valve may be tested (e.g., to determine if the stent valve will allow sufficient blood flow) if the stent valve is in a partial expansion configuration.
[0016] In some embodiments, the stent valve delivery system may include at least one balloon (e.g., proximal to the stent valve or other stent ready for insertion) configured to allow stent valve expansion or stent placement when at least one balloon is inflated.
[0017] In some embodiments, the stent valve delivery system may include a push handle causing the relative movement of the first and second systems. Alternatively, the stent valve delivery system may include a screw mechanism to change the rotational movement of the holder into the relative movement of the first and second systems.
[0018] In some embodiments, the stent valve delivery system may include an integrated introducer in which the first and second systems are positioned when introducing the stent valve into the implantation site. The integrated introducer can be configured to remain in the patient's body even after recovery of the first and second systems, for example for the introduction of an occluder.
[0019] In some embodiments, after the stent valve has fully expanded, the delivery system may be configured to return to the closed position by passing the second system through the stent valve toward the distal end of the first set.
[0020] Still other embodiments disclosed in the present application relate to a method of inserting a stent valve into the implantation site, where the stent valve is detachably attached to the insertion device and the stent valve is inserted into the implantation site in a closed configuration. The stent valve may be partially expanded while remaining attached to the delivery device. A decision on a stent valve can be made when the stent valve is in a partial expansion configuration. If the decision meets a positive response, the stent valve can be fully expanded by allowing the stent valve to detach from the delivery device.
[0021] In one particular embodiment, it is possible to determine if the stent valve has been properly positioned at the implantation site. The stent valve may return to the closed configuration and be repositioned if it is incorrectly positioned at the implant site.
[0022] Alternatively or additionally, it can be determined whether the stent valve component is functioning properly by, for example, checking that the valve component allows sufficient blood flow. The stent valve may return to the closed configuration and may be removed from the patient's body in the event of its malfunction.
[0023] In some embodiments, introducing the stent valve into the implant site may include introducing the stent valve into the heart for replacement of the heart valve. The introduction may include access to the patient's body through the intercostal space (e.g., the fifth intercostal space) and penetration of the left ventricle at the end of the heart.
Brief Description of the Drawings [0024] To allow a better understanding of the present invention, reference is made to the following description regarding the attached drawings, in which the respective references correspond to the relevant parts of the description:
[0025] FIG. 1A illustrates a valve component in an expansion configuration according to some embodiments disclosed in this application;
[0026] FIG. 1B shows a valve component in a closed configuration according to some embodiments disclosed in this application;
[0027] FIG. 2A illustrates a stent component in an expanded configuration according to some embodiments disclosed in this application;
biological unit [0028] FIG. 2B illustrates a unit valve comprising a stent component and a valve component in an expansion configuration in accordance with some embodiments disclosed in this application;
[0029] FIG. 2C presents a unit valve in a closed configuration, according to some embodiments disclosed in this application;
[0030] FIG. 3A illustrates a stent component in an expansion configuration, according to some embodiments disclosed in this application;
[0031] FIG. 3B illustrates a stent component in a closed configuration, according to some embodiments disclosed in this application;
[0032] FIG. 4 illustrates a two-stent valve consisting of two stent components and a valve component in an expanded configuration, according to some embodiments disclosed in this application;
[0033] FIG. 5A-7B depict the use to replace damaged (artificial) in accordance with some embodiments disclosed in this application;
[0034] FIG. 8A-8B show a stent component consisting of fasteners for attaching a stent at the implant site according to some embodiments disclosed in the present application;
[0035] FIG. 8C shows a stent component with a diameter in the region of the attachment member (s) smaller than the diameter of the stent area in which the valve is located, according to some embodiments disclosed in this application;
valve valves examples [0036] FIG. 8D illustrates a stent component consisting of an independently bendable component (s) for use in positioning / attaching the stent to geometry / topology at the implant site according to some of the embodiments disclosed in this application;
[0037] FIG. 8E shows a stent component consisting of locking elements in a crown configuration and a fastener for attaching the stent at the implant site according to some embodiments disclosed in the present application;
[0038] FIG. 8F shows a stent component consisting of a large number of struts for positioning the valve component closer to the area of the stent component consisting of the attachment element (s) for attaching the stent component to the delivery device;
[0039] FIG. 9A-16 show additional embodiments of stent components consisting of fasteners for securing the stent in the insertion device and / or fasteners for securing the stent at the implantation site in accordance with some embodiments disclosed in this application;
[0040] FIG. 17/18, 19 and 20 show additional examples of two-stent valves in accordance with some embodiments disclosed in this application;
[0041] FIG. 21A illustrates an opposing double crown stent in accordance with some embodiments disclosed in this application;
[0042] FIG. 21B-E show a view of a two-conical stent in accordance with some embodiments disclosed in this application;
[0043] FIG. 22A-22D show a system for introducing a self-expanding stent valve into an implant site according to some embodiments disclosed in this application;
[0044] FIG. 23A-23D show an inflatable balloon (s) delivery system according to some embodiments disclosed in this application; [0045] FIG. 24A-24D show an introduction system having a proximal outer shaft with increased diameter according to some embodiments disclosed in this application;
[0046] FIG. 25A-25C show an inflatable balloon (s) delivery system according to some embodiments disclosed in this application; [0047] FIG. 26A-26C show an insertion system with an integrated introducer according to some embodiments disclosed in this application;
[0048] FIG. 27 is a graph describing the steps of replacing a damaged natural or artificial valve in accordance with some embodiments disclosed in this application; and [0049] FIG. 28A-C illustrate the replacement of a damaged valve using an insertion system according to some embodiments disclosed in the present application;
Detailed description of the invention [0050] FIG. 1A-3B show items 100, 200 and 300 used to replace, for example, a damaged (e.g. degenerative) aortic valve, mitral valve or pulmonary valve (e.g. in pediatric patients) according to some embodiments of the present invention. In more detail, FIG. 1A and 1B show valve component 100. FIG. 2A-2C show a stent component 200 for accommodating valve component 100. FIG. 3A and 3B show a stent component 300 for accommodating a stent component 200 and a valve component 100. A device consisting of components 100 and 200 may also be referred to as a unit valve. A device that additionally includes an element 300 may also be referred to as a two-hundred valve.
[0051] FIG. 4 shows a two-stent valve 400 consisting of valve component 100, stent component 200, and stent component 300 in accordance with some embodiments of the present invention. The 400-valve can replace a damaged natural or artificial valve. The expression "natural valve" refers to a natural valve that is in the patient's body. A damaged natural valve may be, for example, a stenotic valve. The term "artificial valve" refers to a biological or synthetic (e.g. mechanical) valve introduced into the patient's body by surgery. The implantation site for device 400 (or other valve prosthesis) typically includes at least part of the area within the damaged valve and / or along at least part of the adjacent structure (s). For example, to replace a damaged aortic valve, device 400 may be implanted into the patient's body so that the device portion 402 will largely be positioned completely inside the damaged aortic valve. Part 404 of device 400 may extend along at least part of the aorta. Part 406 of device 400 may extend at least into the patient's left ventricle.
[0052] The two-centered valve 400 may be introduced into the implantation site using a suitable insertion method. In some embodiments of the present invention, the device 400 may be substantially completely assembled from the components 100, 200 and 300 outside the patient's body prior to introducing the device 400 into the implantation site. In other embodiments of the present invention, the components 100, 200 and 300 of the device 400 may be introduced into the implantation site separately in several stages. For example, element 300 may be inserted and installed at the implant site after insertion and installation of stent element 200 and valve element
100 in one or more separate stages. In one embodiment, the elements 100 and 200 may be assembled outside the patient's body, and then inserted and installed inside the element 300 simultaneously. In another embodiment, the stent component 200 may be inserted and installed within the stent component 300 after the separate insertion and installation of valve component 100 has been previously performed. Additional embodiments of two-hundred valve systems are described with reference to
FIG. 17-20.
[0053] In some embodiments of the present invention, the one-valve valve (FIG. 2B) comprising the valve component 100 and the stent component 200 (but not the stent component 300) may be used to replace a damaged natural or artificial valve. For example, in one particular embodiment, the one-valve valve may replace the damaged biological valve previously introduced into the patient's body during surgery. Therefore, surgery involving the introduction of the unit valve as shown in FIG. 2B may be the second or subsequent valve replacement procedure. Although in this embodiment, the introduction of a new stent component 300 into the patient's body is not envisaged, the unitary valve comprising the elements 100 and 200 may be located within the stent and / or the valve remaining at the implant site since the previous valve replacement procedure. In some embodiments, at least a portion of the stent and / or valve from a previous procedure may be removed prior to placing the unit valve at the implantation site. Additional details for replacing a damaged biological valve with a single valve are given with reference to FIG. SA-7B.
[0054] In some embodiments of the present invention, the valve component 100 may be flexible and may be in a closed form, i.e. in a closed form, for example, it may be inserted through the catheter into the implantation site. In the following with reference to FIG. 22A-26C, various embodiments of delivery systems and minimally invasive surgical methods have been described. At the time of insertion, the valve member may be at least partially expanded. FIG. 1A is a view of valve component 100 in its expanded configuration. FIG. 1B is a view of valve component 100 in a closed configuration. The terms "expanded configuration" and "closed configuration" used in this application refer to a relative difference in, for example, the diameter and / or other physical characteristics of the element (e.g. length, width). For example, the closed valve component shown in FIG. 1B has a reduced diameter and may be longer than the expanded valve component depicted in FIG. 1A.
[0055] The valve component 100 may consist of biological (heterologous or autologous) material, non-biological material, synthetic material (e.g. polymers such as polyurethane and / or silicone) or combinations thereof. In some embodiments, the valve component 100 may consist of preserved biological tissue such as, e.g., human tissue (e.g., homographs, valve tissue autographs) or animal tissue (heterographs or xenografts). In some embodiments, the valve component 100 may be a mechanical valve. For example, in the case where the valve component 100 is a biological valve, expansion of the valve component 100 from a closed form may require self-expansion of the attached stent component 200. For comparison, the synthetic valve component 100 may be adapted to self-expand. The valve component 100 may have a shape / form (e.g. length, width, diameter, etc.) appropriate to its use (e.g. tricuspid, mitral valve, pulmonary valve or aortic valve). In FIG. 1A and 1B, valve component 100 is a tricuspid valve with three flaps. This configuration is extremely suitable, for example, for replacing a damaged aortic valve. In other embodiments, valve component 100 may have any number of flaps and / or other physical features (e.g., diameter, length, width, etc.).
[0056] FIG. 2A is a perspective view of a stent component 200 according to an embodiment of the present invention. As seen in FIG. 2B, valve component 100 is disposed in stent component 200. In some embodiments, at least a portion of stent component 200 may have a cylindrical shape. Alternatively or additionally, the stent member 200 may have an indentation (annular groove) or other attachment member 202, for example, to attach the stent at the implantation site. For example, in the case where the stent component 200 is part of a two-stent valve 400 (FIG. 4), the fastener 202 may be attached to the complementary fastener 302 (e.g., the inwardly projecting annular portion, FIG. 3A) of the stent component 300. In the case where the stent component 200 is part of a unit valve (FIG. 2B), the attachment member 202 may be attached to at least a portion of the damaged valve. Additional embodiments of stent components that may include fasteners are described with reference to FIG. 6A and 8A-16.
[0057] In some embodiments of the present invention, the stent component 200, like the valve component 100, may be in two configurations: a first closed configuration (e.g. during insertion) and a second expanded configuration (e.g. after installation). FIG. 2A shows the stent element 200 in the expanded configuration. FIG. 2C shows a closed configuration stent element 200 with an unstretched valve element 100 inserted therein, for example for the purpose of simultaneously introducing both elements to the implantation site. In some embodiments, the stent component 200 may be made of wire or laser cut from a tube, sheath, etc. The stent component 200 may be made of an alloy having shape memory such as, for example, nitinol. The shape memory alloy allows the stent element 200 (and / or valve element 100) to be assembled for the first configuration, for example, for insertion through a small opening in the patient's body and to expand the stent element 200 into the second configuration during installation. Elements 100 and / or 200 may remain in a closed configuration, e.g. inside a casing or wrapper. The casing / wrapper can be removed allowing elements 100 and / or 200 to go to the second configuration.
[0058] The valve component 100 may be attached to the stent component 200 by a suitable attachment mechanism or combination of attachment mechanisms. For example, in one embodiment, the valve component 100 may be sewn through one or more seams to the stent component 200. In another embodiment, the valve component 100 may be attached to the stent component 200 by friction attachment. For example, the diameter of the valve component 100 in the full expansion configuration may be slightly larger than the diameter of the stent component 200 in the full expansion configuration, so that the components 100 and 200 adhere well to each other when the component 100 expands inside the component 200. In yet another embodiment for attachment valve component 100, a fastening system consisting of a hook and loop (e.g. VELCRO®) may be used for the stent component 200. For example, the stent component 200 may include microscopic hooks and the valve component 100 may include corresponding microscopic loops (or vice versa). Such a fastening system can be built of a micro velor previously used in surgical procedures carried out to accelerate tissue growth. Such a fastening system allows the valve element 100 to be positioned precisely relative to the stent element 200, e.g. after implanting elements 100 and 200 in the patient's body. Hooks / loops can also facilitate blood clotting and seal formation at the contact point between valve component 100 and stent 200 component. To avoid premature clot formation (e.g. excessive clot formation before installation is complete), the patient may be monitored for coagulation and / or anticoagulant treatment. Strong connections of hooks and loops are possible even in the case of premature clot formation, although it may be necessary to use a higher activation pressure (described below). Preliminary evaluation shows that strong hook and loop bonds are possible with water, jelly, liquid soap, and / or coagulation proteins. In some embodiments, this attachment system may be used alternatively or additionally to attach the stent component 200 to the stent component 300 (e.g., through microscopic hooks attached to the outer surface of the stent component 200 and microscopic loops attached to the inner surface of the stent component 300, or vice versa) .
[0059] Any suitable mechanism or combination of mechanisms (e.g. direct or indirect use of mechanical compression) can be used to provide the activation pressure necessary to attach the micro-hooks to the micro-loops. For example, in some embodiments, one or more balloons may be adjacent to valve component 100 and / or stent component 200 (e.g., inside the valve component 100) and such balloons may be temporarily inflated to allow connection of the micro-hooks with the micro-loops. Such a balloon (s) may be placed inside the valve component 100 and / or the stent component 200 after the stent and / or valve has been inserted into the implantation site. Alternatively, in some embodiments, the balloon (s) may be placed (e.g. allowing it to be removed) inside valve component 100 and / or stent component 200 prior to introducing the stent and / or valve to the implementation site (e.g., prior to placing the stent and / or valve in the delivery device). The use of such a balloon (s) is not limited to the embodiments in which the valve and stent are attached to each other through hooks / loops. In fact, such a balloon (s) can be used freely when it is necessary or desirable to facilitate the expansion and / or placement of the stent and / or valve at the implantation site (e.g., when the valve is stitched to the stent).
[0060] FIG. 3A is a perspective view of a stent component 300 according to an embodiment of the present invention. As described above, the stent component 300 may have a fastener 302 (e.g., an inwardly projecting annular portion) attached to complementary fastener 202 of the stent component 200 (FIG. 2A). FIG. 4 shows an embodiment of such a connection where element 300 has element 100 and element 200 forming a 200-valve. The geometry (e.g., length, width, diameter, etc.) of the stent component 300 may be particularly suitable for aortic valve replacement. Other embodiments may show different geometry and configuration of the stent component 300.
[0061] The stent component 300 may be located at the implantation site by any suitable fastening mechanisms or combination thereof. For example, in some embodiments, the attachment member 302 may form a niche (e.g., outer annular groove) for receiving at least part of the damaged valve. In some embodiments, the diameter of the stent component 300 may be slightly larger than the diameter of the implantation site, such that the insertion and expansion of the stent component 300 at the implantation site secures the stent component 300 by friction attachment. In some embodiments, the stent element 300 may include one or more protruding elements (e.g.
spikes) or clamps to anchor the stent component 300 to the damaged valve and / or adjacent structure (s) at the implantation site.
[0062] FIG. 5A-7B show embodiments of the present invention for replacing damaged artificial (e.g., biological) valve (e.g., stent valve) introduced into a patient's body during prior surgery. FIG. 5A is a perspective view of a damaged biological valve 500 where the valve petals 502 do not close. FIG. 5B is a perspective view of a damaged biological valve 500 after implantation of the stent valve shown in FIG. 2B. As can be seen, the damaged biological valve 500 (e.g., and / or the associated stent) secures the new stent valve at the implantation site. More specifically, stent valve attachment member 202 (FIG. 2A and 2B), which may be an annular groove forming the narrowest part of the stent valve, may receive the damaged biological valve ring 500, thereby securing the stent valve. In other embodiments of the present invention, at least a portion of the damaged biological valve 500 may be removed from the patient's body (e.g., the damaged valve itself), and the remainder (remaining parts) of the damaged valve may remain at the implantation site (e.g., stent). In other embodiments, the damaged biological valve 500 along with all components can be completely removed from the implantation site prior to installing the new stent valve.
[0063]
FIG. 6A is a perspective view of another example of a stent valve 600 according to an embodiment of the present invention.
FIG.
6B is a perspective view illustrating the use of a stent valve 600 to a damaged valve e.g.
biological (e.g. three) artificial substitution
The stent valve includes one or more locking or retaining mechanism 602 located along the outer surface of the stent component. Each of the blocking mechanisms 602 is configured to collapse (e.g., blends into the outer surface of the stent component) as soon as the blocking component contacts a different surface (e.g., the interior of the catheter). In the case where the locking element projects from the outer surface of the stent element, the first end 604 of the blocking element may be adjacent to the outer surface of the stent element, and the second blocking element 606 of the blocking element may be remote from the outer surface of the stent element. In the case of multiple locking elements 602, the first ends 604 of all locking elements may be positioned substantially at the same height / vertical position along the central axis of the stent component (e.g., evenly distributed around the stent component). The second ends 606 may be located at a different height / vertical position than the first ends 604. The first end 604 may be flexible (e.g. allowing hinged movement in two planes) so that the movement of the other end relative to the outer surface of the stent component does not weaken the locking mechanism.
[0064] In some embodiments of the present invention, the stent valve 600 may be located inside the damaged valve in the direction of the arrow 608 shown in FIG. 6B. Once the first end 604 of each blocking element 602 contacts the inner diameter / ring of the damaged valve, the second end 606 of the blocking element may collapse toward the outer surface of the stent element. Once the other end 606 of the blocking element reaches the open space of the damaged valve, the other end may protrude outward blocking the stent valve 600 in place. Thus, the locking elements 602 may be a mechanism for attaching a new stent valve as an alternative or additional method of attaching the valve to the method of attaching it using the attachment element 610 (e.g. annular groove) of the stent component for attaching the stent valve 600 to (e.g.) the damaged valve ring.
[0065] FIG. 7A and 7B show another embodiment of a stent element 700 with locking elements according to the present invention. As seen in FIG. Such a stent element can be made, for example, of a sheet made of a suitable material (e.g. nitinol). Referring to FIG. 7B, the stent component includes one or more blocking elements 702 extending radially from the outer surface of the stent component, such that for each blocking element, the first end 704 and the second end 706 of such blocking element are located substantially at the same height / in the same vertical position along central axis of the stent element. In other embodiments, such locking elements may be positioned at a small angle such that the ends 704 and 706 of the same locking element are positioned at a different height / vertical position along the central axis of the stent element. In some embodiments, a stent component comprising a plurality of locking elements is provided, with each locking element having ends 704 and 706 of different angular orientation. Different locking elements 702 may be located at the same or different height / in the same or different position along the central axis of the stent element.
[0066] FIG. 8A-16 show additional examples of suitable stent components for use in valve replacement in accordance with some embodiments of the present invention. These stent components can be used, for example, as part of one- and two-stent valves. Each of these elements includes one or more attachment elements for attaching the stent element enabling it to be retracted (e.g., together with the integrated valve element) to the delivery device (FIGS. 22-26). In some embodiments, these stent components may also include a fastener (e.g., similar to fastener 202 (FIG. 2A) for attaching the stent component at the implantation site.
[0067] FIG. 8A is a perspective view of the stent component 800 in a closed configuration, as well as a cross-sectional view of the stent component 800 illustrating its structure in detail. FIG. 8B shows the stent element 800 in an expanded configuration. The stent component 800 includes a first (e.g., proximal) section 802 composed of a fastening element (e.g. annular groove), a second section 84 of a shape that coincides with the shape of the valve member to be positioned within the stent component, and a third section (e.g., distal) 806 containing one or more (e.g., three) attachment members 808. In some embodiments, stent 800 may comprise (e.g.) a truss (formed e.g. from a wire made of nitinol) with a larger number of meshes in section 802 than in section 804 and / or section 806. This solution can provide additional support for the fastener in section 802 and thereby increase the stability of the device 800 at the implantation site. In some embodiments, the stent component 800 may only contain closed truss cells to facilitate recovery of the stent component 800 by the delivery device when the stent component 800 is in a partially expanded configuration (described below).
[0068] In some embodiments, each of the attachment members 808 may consist of an opening (e.g.
round or oval) to attach the stent element 800 allowing it to be removed to the complementary element (e.g., wire, tape or hook) of the delivery device.
intracoronary
The fasteners 808 may allow a partial expansion of the stent component (e.g., together with an integrated valve component and / or other stent component) within the patient's body, while the stent component will remain attached to the delivery system. For example, sections 802 and 804 (e.g. and part of section 806) of the stent component 800 may expand while the stent component is partially released from the shaft during insertion, while there is no change in the positioning of the attachment members 808 relative to each other in the shaft (e.g., see FIG. 28 "partial release" ). This allows the surgeon to reposition and / or check the functionality of the stent valve (or binary valve) inside the patient's body before completing the stent valve attachment at the implantation site. This valve function check may include peripheral pulse wave monitoring, where the pulse wave is measurable if the valve is functioning properly. A more reliable way to assess the correct functioning of the stent valve is transesophageal (TEE), (IVUS) and / or intracardiac (ICE) echocardiography. If a cardiac valve defect occurs during the test (e.g., if the valve prevents sufficient blood flow), the stent valve can be completely removed by the insertion device and removed from the patient's body. In other embodiments, the stent element 800 may have a different truss structure, the length and / or other dimensions of the fastening elements increased or reduced, and / or the fastening elements may be positioned at other positions relative to the stent element 800 echocardiography echocardiography (e.g., inside section 804) .
[0069] FIG. 8C illustrates another embodiment of the stent component with integrated fasteners 814 configured such that the fully expanded diameter in the vicinity of the fastening element (s) is smaller than the diameter of the area in which the associated valve is located. As can be seen from the example, the fastening elements partially protrude towards the central axis of the stent element. This may reduce the risk of injury to the patient (e.g., perforation of the artery) by fasteners. Alternatively or additionally, this may facilitate attachment of the fastening elements to the complementary structure of the insertion device. For example, when the device is in a closed configuration to be attached to the insertion device, the reduced diameter around the fasteners may cause the fasteners to attach to the stent holder earlier.
[0070] FIG. 8D illustrates yet another embodiment of the stent component of the present invention. In this embodiment, the first (proximal) section of the stent comprises 27 independent and bendable elements 816, each of which may include connected and / or disconnected cells (cell) that can be open and / or closed. In this embodiment, each of the bendable elements comprises a single, closed cell. In other embodiments, a different number and / or configuration (configurations) of bendable components is envisaged. The bendable elements 816 allow precise placement / attachment of the proximal stent section to the geometry / topology (for example) of a calcified ring / damaged biological valve. Each element 816 can bend / adjust independently to the topology of the immediately adjacent portion of the calcified ring / damaged biological valve. The bendable elements 816 together form an annular groove in which the deformation location of the bend (grooved portion) for each bendable element is controlled by shortening or lengthening the attached pair of stent struts (818, 820) acting as a hinge. The length of a single stent strut is designated by number 822. First of all, the radial force / resistance of each bend 816 depends on the choice of slope 824 in the production of the stent. Other design parameters such as thickness / width also affect radial force. The advantage of this solution is that the proximal stent section can more properly anchor the stent at the implant site regardless of the center section of the stent. Therefore, the central section of the stent can be designed to accommodate (for example) the aortic valve without increasing the size, thereby reducing the risk of valve damage due to prolonged mechanical pressure. The stent of FIG. 8D also includes a compensating element 826 (e.g., a triangular wavy portion and two longitudinal arms) for correcting the mismatched length (if any) inside the stent during production and / or folding. In turn FIG. 8D with the embodiment shown in FIG. 8C, in which the lack of spacers prevents the proximal part of the stent from possessing elements that bend independently (e.g. during implantation).
[0071] FIG. 8E shows another embodiment of a stent component according to the present invention. FIG. 8E shows only about 1/3 of the cross-section of the stent element, thanks to which it is possible to more clearly represent its features. The stent component shown in FIG. 8E, like the locking / retaining elements 602 shown in FIG. 6A and 6B, includes a plurality of independently bending locking elements 828 generally located within the area of the stent component number 804 in FIG. 8B. The blocking elements 828 form a crown that can attach to, for example, a damaged biological valve or calcified natural ring on the outflow side. The stent component of FIG. 8E also includes a fastener 830 (e.g., annular groove). In FIG. 8E, fasteners 828 are shown as being positioned at substantially the same place / height along the central axis of the stent component. In other embodiments, different locking elements 828 may be located at the same or different height / in the same or different position along the central axis of the stent component, similar to the stent component of FIG. 7B. A different position / height for some of the 828 blocking elements may facilitate their attachment to, for example, natural valves of various types (e.g., a thin natural valve to which blocking elements separated by a short distance can be attached, or a thick natural valve to which blocking elements can be attached separated by a greater distance.
[0072] FIG 8.F shows another embodiment of the stent component of the present invention. FIG. 8F shows only about 1/3 of the cross-section of the stent element, thanks to which it is possible to more clearly present its features. FIG. 8F shows the Dacron 832 pocket in which the valve component is located, where the Dacron 832 pocket is sewn along the free edge of the 834 valve. As can be seen, the valve member inside pocket 832 is positioned closer to the fastener (s) 836 more similar to the fasteners 808 of FIG. 8B in the embodiment of FIG. 8F than in the embodiment of FIG. 9C. The middle U-shaped 838 spacer is slid into the Dracon 832 pocket. The valve / pocket is sewn to the inverted U-shaped outer spacer. The inverted U-shaped strut 842 is located outside the Dracon 832 pocket and is a kind of washer when loading / unloading / retrieving the implant using an insertion device, reducing friction between the Dracon 832 pocket and the outer shell. The U-shaped inner spacer may also be sewn into the Dracon 832 pocket. In some embodiments, the Dracon 832 pocket may be closed with a seam 844. Although the underside of the stent is not shown in FIG. 8F, in some embodiments, it may include, for example, a fastener (e.g., annular groove) similar to the fastener 802 of FIG. 8B.
[0073] FIG. 9A-9C show another example of a stent component 900 with an integrated attachment element (integrated attachment elements) 902 in accordance with one embodiment of the present invention. FIG. 9A is a perspective view of the stent element 900 in a closed configuration, as well as a cross-section of the stent element 900 illustrating details of its construction. FIG. 9B is a perspective view of stent component 900 in an expanded configuration. FIG. 9C shows a stent element 900 (with an integrated valve element) with a ruler illustrating its size attached to it (e.g., about 4 centimeters). As can be seen, each of the fastening elements 902 includes a round or oval hole attached to the stent element 900 by means of two supporting elements 904 (e.g., wires). In turn, each pair of support elements 904 is attached to the core 906 (e.g. commissural post) inside the truss. In turn, each of the attachment members 808 shown in FIG. 8B is attached to the stent component 800 by a single support element 810, and each support element 810 is attached to the core 812. All of the stent components depicted in FIG. 8A-16 contain three cores, although according to some embodiments of the present invention, another suitable number of cores or lack thereof is also envisaged (e.g., FIG. 2A). The stent element 900 also includes substantially similar to the element
2A). In FIG. 9C, the valve component is sewn around the circumference of its ring. Each of the three petals of the valve component is also sutured in specific places, which improves valve operation. The location of the sutures should be selected to allow elongation of the stent during folding without compromising the valve or sutures. For example, the stent inlet (e.g., within the area 802 shown in FIG. 8B) may be covered from the inside with material (e.g. net). The valve material and component may be sewn to the stent (e.g., with a continuous technique, attachment element 908, attachment 202 (FIG. And / or intermittent) in an area adjacent to the annular groove (e.g., along the edges of the stent sections 802 and 804 of FIG. 8B). Excess material from the inlet side can be stretched to the outside of the stent and stapled together with the valve component nearby (e.g., further toward section 804) of the previous stapling location. The valve element seams may also be attached to appropriate stent posts that may have previously been covered with material (e.g., Dacron). Alternatively, pericardium or other material may be used to cover the stent component. In some embodiments, a pig valve may be used, which may be taken as such or composed of components from different donors to achieve optimal alignment of the three vertices. Cow or horse pericardial valves may also be used. Other suitable valve sources may also be used.
[0074] FIG. 10A-10B illustrate yet another example of a stent 1000 with an integrated attachment element (s) 1002 according to an embodiment of the present invention. FIG. 10A is a perspective view of stent 1000 in a closed configuration, as well as a cross-section of stent 1000 illustrating details of its structure. FIG. 10 B is a perspective view of stent 1000 in an expanded configuration. As you can see, at least one pair (e.g. all pairs of) attachment elements 1002 are attached to each other by means of clamp 1004. Each clamp 1004 may be attached at one end to the first attachment element 1002 and at the other end to the second attachment element 1002. In some embodiments, the clamp 1004 may contain a triangular wave wire. In the event that all fasteners 1002 include a clamp 1004, the clamps 1004 may together form a circle around the stent 1000. Stent 1000 may be substantially the same as stent 800 (FIG. 8B). in all other aspects.
[0075] FIG. 11-16 show additional examples of stents with an integrated attachment element (integrated attachment elements) according to some embodiments of the present invention. FIG. 11-16 are a perspective view of the stent in a closed configuration, as well as a cross-section of the stent illustrating the details of its construction. The following description applies to the various features of the stents shown in FIG. 1116. Additional design features of the embodiments shown in FIG. 11-16 will be readable by experts after reading the drawings.
[0076] FIG 11. Shows a stent comprising a shorter support element (shorter support elements) for attaching the appropriate number of oval / round attachment elements (i.e. shorter compared to the support elements 810 of FIGURE 8B). The stem (stems) of FIG. 11 attached to the support members may be substantially the same as the stems 906 of FIG. 9B.
[0077] FIG. 12 shows a stent comprising two support elements for attachment to each oval / circular attachment element. Each pair of support elements attaches to the shaft so that all the support elements and the shaft form a second oval / round hole, for example, for additional support and / or for use as an additional or alternative attachment. The stem (stems) of FIG. 12 may be substantially the same as the stems
906 of FIG. 9B.
[0078] FIG 13. Shows a stent comprising non-round / oval fasteners such as, for example, wires, hooks, tapes or a combination thereof for attaching to the complement of the insertion device (e.g. round or oval hole). The stent of FIG. 13 also includes an increased number of fasteners (e.g., six) compared to the number of fasteners (e.g., three) in stent 900 (FIGS. 9A and 9B). In FIG. 13 fasteners attach directly to the stent shafts, two fasteners for each shank. The stem (stems) of FIG. 13 may be substantially the same as stems 906 of FIG. 9B.
[0079] FIG. 14 shows the stent replacing the fasteners in the form of wires / hooks of FIG. 13 narrow holes (e.g., long and narrow holes compared to the fasteners 902 of FIG. 9A). The stem (stems) of FIG. 14 may be substantially the same as stems 906 of FIG. 9B.
[0080] FIG. 15 shows a stent with a modified truss and a modified shaft structure. The stent of FIG. 15 also includes round / oval fasteners, where each fastener is attached to the shaft by two support members. Each pair of support elements and the corresponding shaft may form a second circular / oval hole in a manner similar to the support / shaft configuration shown in FIG. 12. [0081] FIG. 16 shows a stent with fasteners modified relative to the fasteners shown in FIG. 15. Each of the fasteners of FIG. 16 comprises a wire (e.g., a U-shaped wire), both ends of which are attached directly to the same shank so that the attachment / shank configuration forms a substantially oval / round hole. The stem (stems) shown in FIG. 16 may be substantially the same as the stems depicted in
FIG. 15.
[0082] FIG. 17, 18, 19 and 20 show additional examples of two-stent valves in accordance with some embodiments of the present invention. 1700 one-way valve of FIG. consists of stent 1702 and valve 1804. FIG. 18 shows a two-stent valve consisting of a stent valve 1700 and a positioning stent 1802 that can be joined together by (for example) an annular groove and a corresponding annular niche. Stent 1802 may be covered with, for example, pericardium to prevent periarticular leakage. Two-centered valve of FIG. 18 may generally have a cylindrical shape suitable for e.g. pulmonary and / or aortic applications.
[0083] Referring to FIG. 19 and 20, FIG. 19 shows a two-stent valve consisting of the first stent 1902, the second stent 1904 and the valve 1906. FIG. 20 shows a two-stent valve consisting of the first stent 2002, the second stent 2004 and the valve 2006. The positioning stents of FIG. 19 and 20 may be covered (e.g. with pericardium) to prevent periarticular leakage. The stents of FIG. 19 and 20 may be suitable e.g. for pulmonary valve replacement or (e.g. in the case of a deforming aneurysm where there is no suitable edge to position the grooved stent valve). Particularly with respect to the use of the pulmonary valve, many people who qualify for pulmonary valve replacement have an aneurysm at this point, or the inflow and outflow opening is funnel-shaped. Therefore, the first stent 1902 or 202 can conform to such a funnel-like shape of the pulmonary artery and form a round hole to attach the stent valve (1904, 1906) or (2004, 2006). Some embodiments provide a two-centered valve similar to the two-hundred valve in FIG. 20, suitable for use with two and / or tricuspid valves, where the positioning stent has a reduced height and an oval configuration with a round edge for attaching to the stent valve groove (alternatively, a fastening system consisting of hooks and loops can be used). Alternatively or additionally, the positioning stent may have independently bendable elements ensuring stable fixation at the implantation site. Additional design features of the embodiments shown in FIG. 17-20 and details of their use when replacing the valve will be readable by experts after reading the drawings.
[0084] FIG. 21A shows another example of a 2100 stent valve according to some embodiments of the present invention. The embodiment shown in FIG. 21A may be suitable for, for example, mitral valve replacement. The 2100 stent valve may be assembled from the stent and valve outside the patient prior to introducing the 2100 stent valve into the implantation site. The 2100 stent valve may be a self-expanding valve adapted for a mitral valve replacement. As you can see, the 2100 stent valve may have an inverted double crown shape. The 2100 stent valve may consist of cow's 2102 pulmonary valve stitched to the Dacron tube (prosthetic tube) with two self-expanding nitinyl stents, type Z-stent 2104 and 2106, sewn on the outside of the prosthesis to form two self-expanding crowns. The self-expanding stent valve may be loaded for insertion into a Teflon sheath or other suitable delivery system. In this embodiment, Dacron was used to cover the stent, although other embodiments provide for the use of materials such as Teflon, silicone, pericardium, etc. According to one of the surgical methods, a one-centimeter incision is required in the left atrium of the heart using capillary sutures. The Teflon stent sheath can be pushed along the guide wire (after puncturing the atrium with a needle and inserting the guide wire) until the middle part of the stent valve reaches the bifurcation ring. Then, the sheath can be pulled out for installation towards the ventricle, and then pulled out completely to expose the atrium. Additional details about the 2100 stent valve and the method of surgical introduction to the implant site are described in Liang Ma et al. "Double-crowned valved stents for off pump mitral Valle replacement", European Journal of CardioThoracic Surgery 28: 194-199, June 2005.
[0085] FIG. 21B-E show a view of a two-conical stent in accordance with some embodiments of the present invention. Referring to FIG. 21B and 21 C, the two-conical stent may consist of a substantially cylindrical stent 2108 with valve 2110, as well as two substantially conical stents (2112, 2114) attached / attached to the 2108 stent (e.g., by VELCRO®, seam (sutures), attachment friction (friction attachments), other suitable mechanisms or combinations thereof. 21D is a cross-sectional view of the stent of FIG. 21B and 21C. In other embodiments, at least one of the stents 2112 and 2114 may be crown-shaped with protruding spikes formed from open or closed cells or Z-stent stents. The first and second additional stent (2112 and 2114) may together form a fastener 2116 (FIG. 21 C, e.g., annular groove) similar to the fastener 202 shown in FIG. 2A. Attachment 2116 may allow attachment of, for example, a damaged valve in the opening of a similar size to stent 2108 with valve 2110 or to an anchor stent with a complementary protruding ring-shaped element. In some embodiments, stents 2112 and 2114 (and in addition stent 2108) may be replaced by a single stent in a two-conical configuration (e.g., two cones connected through a continuous area around the fastening mechanism 2116). The advantage of using a separate stent (separate stents) for cones / fastener is that the mechanical pressure of the cones / fastener (e.g., first and second stent 2112 and 2114) can be at least partially separated from the stent 2108 containing the valve. In some embodiments, at least the additional stent or portion thereof closer to the end of the delivery system (e.g., stent 2112) may be recoverable by the delivery system. To facilitate such recovery, the additional stent may be formed in a pyramid or wing 2118 configuration (FIG. 21E). In some embodiments, the wing (s) or stent spikes (2112 and / or 2114) may be formed at different positions / at different heights along the central axis of the stent 2108 similar to, for example, the stent shown in FIG. 7B. Different positions / heights for at least some wings or spikes can facilitate attachment to, for example, natural valves of different sizes. In some embodiments, the stents shown in FIG. 21B-21E (e.g., stent 2108) may include at least one attachment member for attachment to the inserter in a recoverable manner similar to attachment member 808 shown in FIG. 8B.
[0086] FIG. 22A-26C show examples of an delivery system for inserting stent valves (e.g., one or two-stent valves) into the implantation site according to some embodiments of the present invention. In some embodiments, the present invention provides for the use of a minimally invasive surgical procedure performed on a beating heart without having to open the chest and apply extracorporeal circulation. Penetration of the heart can be carried out by means of the epigastric route through a relatively small hole in the patient's body. For example, to replace a damaged aortic valve, penetration of the patient's body can occur through the intercostal space (e.g., the fifth intercostal space), i.e. the area between two ribs. From this point you can reach the left ventricle from the tip of the heart. One method provides that a suitable stent valve delivery system first penetrates the body / heart (e.g., 2600 delivery system (FIGS. 26A-26C), including an integrated introducer. Another method involves the use of a separate introducer sheath. Guidewire (empty needle, catheter, rigid guide) made of wire, etc.) can be introduced through the introducer to facilitate the process of introducing e.g. stent element (s), valve element and / or other devices (e.g. occluder). In some embodiments, the use of a transdermal, atrial, or transventricular method, e.g., tricuspid and / or bifid valve replacement is envisaged. Penetration of the right ventricle for pulmonary valve replacement is also anticipated. These methods contrast with those that require the insertion of a valve by opening the chest. In addition, as described in detail below with reference to FIG. 22A-28C, delivery systems according to some embodiments of the present invention first release the proximal part of the stent valve, which allows the valve to be tested in the event of a wall insertion. If the valve is functioning properly, the distal part may be released. This method contrasts with the introduction systems, where the distal parts of the stents are released first.
[0087] FIG. 22A-22D show a delivery system 2200 consisting of two concentrically arranged parts, a first system (containing elements 2202-2210 and a second system (containing elements 2216-2230). In particular, the first system may consist of a top 2202 at the distal end of the delivery system (with a guide passing through the delivery system and exiting at its end) of the inner shaft 2204, outer sheath 2206, metal shaft 2208, and interference grip 2210. The second system may fold from the outer stem (distal) 2216, conical stem connector 2218, the outer stem (proximal)
2220, stent holder 2222, knot sheath 2224, handle connector 2226, handle bowl 2228, and ring 2230. As can be seen, the push handle 2210 is located at the proximal end of the delivery system. In FIG. 22A and 22B, the outer stem 2220 is halved to show in detail the elements of the delivery system 2200. The valve 2212 and the stent (stents) 2214 form a third system that can be loaded and immobilized between the first and second assemblies.
[0088] Regarding the first arrangement, the inner shaft 2204 functions as a lumen for the guide wire. The tip 2202 is tied at its distal end. In the present application, the term "bonding" refers to any suitable securing / fixing mechanism such as, for example, adhesive bonds comprising cyanoacrylate adhesive or UV adhesive materials or bonds / joints using heat energy to bond individual components. Outer sheath 2206 may be nailed to the proximal end 2202 and may restrict the stent valve (2212, 2214). The outer cover may be perforated to allow the device to flush using the push handle 2210. The proximal part of the first system may be reinforced with a metal shaft 2208 and may be attached to the push handle with a luer connector to allow the light of the guide hole to be flushed.
[0089] Regarding the second arrangement, the stent holder 2222 may be attached distally to the distal outer shaft 2216. FIG. 22 D is a perspective view illustrating how the stent valve (2212, 2214) and stent holder 2222 are positioned. The distal outer stem 2216 may be attached proximal to the proximal outer stem 2220 by means of a conical connector 2218. The proximal outer shaft 2220 can be attached by means of a knot 2224 to a handle system consisting of a handle connector 2226 and a handle cup 2228. The handle system can compress the ring 2230 to seal the delivery system 2220. The luer connector may allow flushing of the device. The flushing mechanism can be used to remove air from the delivery system before entering the body. Alternatively or additionally, the flushing mechanism may be used to cool the stent (e.g., nitinol stent) prior to its release and / or recovery by flushing the stent with cold saline. Cooling the stent can cause a reversible change in its structure reducing the Young's modulus and thus the radial force of the stent and the forces necessary for its introduction and recovery.
[0090] The delivery system 2200 is in the open position (FIG. 22C) when (for example) the push handle 2210 contacts the handle cup 2228. In the open position, the stent valve (2212-2214) can detach from the handle 2222 and relax at the implantation site. Before the delivery system 2200 reaches the open position, the stent valve may be immobilized in the delivery system 2200 by means of a fixation device (for example) and held in place by the stent holder 2222. The stent holder 2222 may be attached to the stent fasteners shown in FIG. 8A-16. The immobilized stent valve can be kept in the folded position by pulling out the first arrangement thereby covering the attachment elements / stent holder 222 with the outer cover 2206. After removing the outer cover 2206 so that it no longer limits the attachment elements, the stent valve can automatically detach from the stent holder 2222 due to the self-expansion properties of the stent valve. The delivery system 2200 is in the closed position (FIG. 22A and 22B) when the outer cover 2206 completely covers the stent valve (2212, 2214) so that the stent valve does not expand.
[0091] The delivery system 2200 is in a partially open position when (for example) the push handle 2210 is partially pressed toward the handle cup 2228. In this partially open position, the stent valve (2212, 2214) is proximal and remains attached distally. to the stent holder 222 with fasteners. This allows for precise implantation / positioning of the stent valve. For example, the stent valve may be partially released proximal to the implant site and slightly pushed distally to the stop. The final release of the stent valve (2212, 2214) occurs when the push handle is fully depressed towards the handle cup 2228 so that the delivery system reaches the open position. FIG. 28B shows a partially open position. In some embodiments, it is envisaged to use the imaging system to determine if the stent valve has been positioned correctly at the implantation site. For example, the use of angiography, intravascular ultrasound (IVUS), intracardiac echocardiography (ICE), transesophageal echocardiography (TEE) or other mechanism (s) or combinations thereof whose imaging mechanism is at least partially integrated with or separate from the delivery system is envisaged.
[0092] During implantation of the stent valve (2212, 2214), the delivery system 2200 may return to the closed position before removing it from the patient's body, for example by holding the first system and pressing the second system distally towards end 2202 / outer sheath 2206. In other examples embodiment, the stent valve release handle may consist of a screw mechanism for changing the rotational movement of the handle into the translational movement of the outer sheath. This type of release system allows the gradual, more precise release and recovery of the stent, as well as the reduction of the release force felt by the surgeon.
[0093] FIG. 23A-23D show another example of a delivery system 2300 according to an embodiment of the present invention. The delivery system 2300 may be substantially similar to the delivery system 2200 (FIG. 22) (e.g., closed position, FIGS. 23A and 23B; open position, FIG. 23C), except that the delivery system 2300 may further comprise one or more composite 2302 balloons (e.g. proximal to stent valve). Unless otherwise indicated, the features depicted in FIG. 23A-23D correspond to the same numbers shown in FIG. 22A-22D, although these numbers are not shown in FIG. 23A-23D for the readability of the drawings. The same applies to the stent insertion systems shown in FIG. 24A-D, FIG. 25A-C, FIG. 26A-C. The balloon 2302 can be inflated / emptied through an additional hole in the proximal outer stem 2304, e.g., for anchoring a stent valve (e.g., a stent valve having no balloons.
with self-expansion valves) at the implant site. FIG. 23D is a section view of "AA" of the lumen structure shown in FIG. 23C. The lumen structure includes 5 tubes 2306 and an inner shaft 2308. In other embodiments, it is envisaged to use other lumen structures 2306 (e.g., two-tube lumen, where a second tube is used to fill and empty the balloon). The delivery system 2310 may also include an access mechanism 2310 for filling / emptying balloons that allows the connection of a syringe or filling / emptying device
Alternatively or additionally, the arrangement of closing pipes may be connected to the access mechanism.
[0094] FIG. 24A-24D show another embodiment of a delivery system 2400 according to an embodiment of the present invention. In the delivery system 2400, the proximal outer stem 2400 may have a larger diameter than the diameter of the proximal outer stem 2220 (FIG.
22). The larger diameter may reduce bleeding when using an delivery system not equipped with an introducer. Alternatively, when using the introducer, the larger diameter may match the inner diameter of the introducer, which in turn depends on the outer diameter of the sheath. The lack of a gap between the introducer and the delivery system can reduce the risk of a problem with the delivery system recovering through the introducer due to blood entrapment. Accordingly, the delivery system 2400 may include a movable tube 2404 filling the gap between the outer and inner assemblies, thereby reducing the risk of the inner system looping under compression, which could cause greater friction forces within the delivery system during stent recovery. Delivery system 2400 may be substantially similar to delivery system 2200 in all aspects (e.g., closed position, FIG. 22A and 24B; open position, FIG. 24C).
[0095] FIG. 25A-C show another embodiment of a delivery system 2500 according to an embodiment of the present invention. The delivery system 2500 may include one or more balloons distal to the stent valve. Placing balloons distally to the stent valve avoids having to introduce the delivery system deeper into the body (e.g. to the ascending aorta) for expansion, thereby reducing the risk of injury and improving the way the device is operated (e.g. by preventing the rigid device from bending over the aortic arch). Balloon (s) 2536 can be used, for example, for valvuloplasty prior to stent valve implantation and / or postdilation of implanted stent valve to optimize stent anchorage. FIG. 25B and 25C show the balloon (s) 2536 in the closed and open positions, respectively. [0096] The first delivery system 2500 may include end 2502, inner balloon stem 2504, outer sheath 2506, and movable tube 2508. The second system may consist of inner (distal) stem 2510, change of stent holder 2512, stent holder 2514, sleeve 2516 , conical stem connector 2518, and outer stem (proximal) 2500. The handle system may include a handle adapter 2522, handle cup 2524, O-ring 2626, metal stem 2528 and push handle 2530. The balloon arrangement may include an outer stem 2532, an inner stem 2534, a balloon 2536, and a Y connector.
[0097] FIG. 26A-C show another example of a delivery system 2600 according to an embodiment of the present invention. The delivery system may include an integrated introducer 2602, which may be an additional system including a second system. The outer cover of the delivery system has been designated 2604. The introducer may include a connecting cable 2606, a closing valve 2608 and a cover 2610 of sealing membrane 2612. The closing valve 2608 can serve as an access point for, for example, a syringe containing fluid (e.g., saline). The connecting cable 2606 can be used to transfer fluid from the syringe to the inner orifice of the introducer, and the sealing membrane 2612 can seal the introducer against the external environment. During stent valve implementation, elements of the 2600 delivery system (e.g. first and second systems) other than the 2602 introducer may be recovered by the introducer. Then, another medical device, such as a closing device, may be introduced through the 2601 introducer. According to another example, intravascular (IVUS) devices (e.g., miniature probe) may be introduced through the 2602 introducer. The 2600 delivery system may be substantially similar to the system introducing 2200 in all aspects.
[0098] FIG. 27 is a graph 2700 illustrating the steps of replacing a damaged (e.g., natural or artificial) valve in accordance with some embodiments of the present invention.
FIG. 28A-28C show (without limitation) the various steps represented in the graph of FIG. 27. During step 2702, a stent valve (e.g., a one- or two-hundred-valve) may be removably attached to the delivery system. For example, one or more fasteners of the stent component (e.g., fasteners 808, FIG. 8B) may be attached to the stent holder of the delivery device (e.g., stent holder 222, FIG. 22). A closing element (e.g., outer cover 2206, FIG. 22) can be placed over the fasteners / stent holder in a folded configuration and attached to the delivery system.
[0099] During step 2706, the stent valve may be partially expanded, for example to determine (step 2708) whether the stent valve has been positioned correctly and / or to check (2710) whether the stent valve is functioning properly. For example from FIG. 28A ("partial release") that the outer cover 2806 may be partially removed from the proximal section 2814 of the stent valve, while the fastening elements 2816 of the stent valve remain attached by the outer cover 2806 to the stent holder
2804.
[0101] During step 2712, when the stent valve has been positioned correctly at the implant site and / or is functioning properly, the stent valve may be detached from the introductory system to allow it to fully expand.
For example, from FIG.
28C final release ") that after removing the fasteners 2816 and stent holder 2804 from the outer sheath 2806, the fasteners 2816 of the stent valve 2802 may detach from the stent holder 2804 automatically (or when the balloon is inflated according to other embodiments) causing full expansion stent valve. The second arrangement of the delivery device may then be reattached to the first assembly / outer cover and removed from the patient's body. For example from FIG. 28C ("recovery of the insertion device") shows that the second system 2818 can be drawn through the stent valve 22802 towards the distal end of the stent valve. Then, the second system 2818 and the first system / outer sheath 2806 are reassembled may be re-drawn through stent valve 2802 in the proximal direction before being removed from the patient. [0102] Once the stent valve is positioned correctly (step 2708), during step 2714 the stent valve may return to the closed configuration and its position in the patient's body may be changed. Such a scenario is shown in FIG. 28B ("stent recovery / repositioning"), where the outer sheath 2806 is slid in proximal direction over the proximal stent valve section 2814 for recovery of the stent valve. Then, the stent valve is repositioned and released so that the stent valve fastener 2820 receives the damaged valve ring 2822. Similarly, in the case of a malfunction of the stent valve found during the test (step 2710), during step 2716 the stent valve may return to the closed configuration and be removed from the patient's body.
[0103] Stent valves (e.g., one- or two-stent) and surgical methods and systems are therefore provided. The disclosure of details of specific embodiments is illustrative only and does not limit the scope of the appended claims. In particular, the applicant envisages the possibility of making changes and modifications which do not depart from the spirit and scope of the invention presented in the claims. Other aspects, benefits and modifications are also considered to fall within the scope of the following claims. The claims presented are representative of the inventions presented in this application. Applicant reserves the right to develop such inventions in later claims.
21371 / EP / 11
EP 2 059 192
Contents2
123 members in 18 offices
Priority claims11
| Document | Office | Kind | Date |
|---|---|---|---|
| 84318106 | United States of America | P | |
| 84318106 | United States of America | P | |
| 70092206 | United States of America | A | |
| 70092206 | United States of America | A | |
| 07818037 | European Patent Office (EPO) | A | |
| 2007007413 | European Patent Office (EPO) | W | |
| 2007007413 | European Patent Office (EPO) | W | |
| EP20070818037 | – | – | – |
| US20060700922 | – | – | – |
| US20060843181P | – | – | – |
| WO2007EP07413 | – | – | – |
Members123
| Document | Office | Kind | |
|---|---|---|---|
| AU2006328896A1 | Australia | A1 | |
| CA2634358A1 | Canada | A1 | |
| WO2007071436A2 | World Intellectual Property Organization (WIPO) | A2 | |
| US2007213813A1 | United States of America | A1 | |
| WO2007071436A3 | World Intellectual Property Organization (WIPO) | A3 | |
| WO2007071436B1 | World Intellectual Property Organization (WIPO) | B1 | |
| AU2007294199A1 | Australia | A1 | |
| CA2657839A1 | Canada | A1 | |
| CA2659690A1 | Canada | A1 | |
| CA2755263A1 | Canada | A1 | |
| WO2008028569A1 | World Intellectual Property Organization (WIPO) | A1 | |
| MX2008008068A | Mexico | A | |
| EP1968491A2 | European Patent Office (EPO) | A2 | |
| KR20080103510A | Republic of Korea | A | |
| DE202007018551U1 | Germany | U1 | |
| CN101374477A | China | A | |
| AU2009200985A1 | Australia | A1 | |
| MX2009002556A | Mexico | A | |
| EP2059192A1 | European Patent Office (EPO) | A1 | |
| JP2009520535A | Japan | A | |
| EP2074964A1 | European Patent Office (EPO) | A1 | |
| US2009171432A1 | United States of America | A1 | |
| US2009171447A1 | United States of America | A1 | |
| KR20090078327A | Republic of Korea | A | |
| KR20090082181A | Republic of Korea | A | |
| JP2009195712A | Japan | A | |
| CN101623217A | China | A | |
| CN101636128A | China | A | |
| JP2010502320A | Japan | A | |
| EP1968491B1 | European Patent Office (EPO) | B1 | |
| AT472985T | Austria | T | |
| ATE472985T1 | Austria | T1 | |
| DE602006015356D1 | Germany | D1 | |
| EP2248486A2 | European Patent Office (EPO) | A2 | |
| AU2007294199B2 | Australia | B2 | |
| EP2248486A3 | European Patent Office (EPO) | A3 | |
| AU2011200683A1 | Australia | A1 | |
| BRPI0716544A2 | Brazil | A2 | |
| EP2316381A2 | European Patent Office (EPO) | A2 | |
| AU2011200683B2 | Australia | B2 | |
| EP2059192B1 | European Patent Office (EPO) | B1 | |
| KR20110089190A | Republic of Korea | A | |
| AT517589T | Austria | T | |
| ATE517589T1 | Austria | T1 | |
| BRPI0722366A2 | Brazil | A2 | |
| EP2316381A3 | European Patent Office (EPO) | A3 | |
| DK2059192T3 | Denmark | T3 | |
| EP2368527A1 | European Patent Office (EPO) | A1 | |
| PT2059192E | Portugal | E | |
| BRPI0620302A2 | Brazil | A2 | |
| ES2368459T3 | Spain | T3 | |
| EP2387973A1 | European Patent Office (EPO) | A1 | |
| SI2059192T1 | Slovenia | T1 | |
| AU2009200985B2 | Australia | B2 | |
| AU2011253586A1 | Australia | A1 | |
| JP2011255195A | Japan | A | |
| PL2059192T3This record | Poland | T3 | |
| CA2657839C | Canada | C | |
| EP2420207A2 | European Patent Office (EPO) | A2 | |
| EP2422749A2 | European Patent Office (EPO) | A2 | |
| EP2422750A2 | European Patent Office (EPO) | A2 | |
| EP2074964B1 | European Patent Office (EPO) | B1 | |
| AT547997T | Austria | T | |
| ATE547997T1 | Austria | T1 | |
| EP2420207A3 | European Patent Office (EPO) | A3 | |
| EP2422749A3 | European Patent Office (EPO) | A3 | |
| KR101146035B1 | Republic of Korea | B1 | |
| ES2381810T3 | Spain | T3 | |
| EP2422750A3 | European Patent Office (EPO) | A3 | |
| CN101374477B | China | B | |
| KR101139186B1 | Republic of Korea | B1 | |
| JP4989675B2 | Japan | B2 | |
| US2012197386A1 | United States of America | A1 | |
| CN101636128B | China | B | |
| JP2012152563A | Japan | A | |
| JP5031838B2 | Japan | B2 | |
| KR20120124498A | Republic of Korea | A | |
| CN102772273A | China | A | |
| KR101258016B1 | Republic of Korea | B1 | |
| CN101623217B | China | B | |
| AU2006328896B2 | Australia | B2 | |
| CA2755263C | Canada | C | |
| AU2011253586B2 | Australia | B2 | |
| JP5465702B2 | Japan | B2 | |
| KR101388813B1 | Republic of Korea | B1 | |
| EP2316381B1 | European Patent Office (EPO) | B1 | |
| CA2659690C | Canada | C | |
| JP5581349B2 | Japan | B2 | |
| ES2494618T3 | Spain | T3 | |
| EP2422749B1 | European Patent Office (EPO) | B1 | |
| EP2420207B1 | European Patent Office (EPO) | B1 | |
| EP2422750B1 | European Patent Office (EPO) | B1 | |
| ES2526563T3 | Spain | T3 | |
| US2015018938A1 | United States of America | A1 | |
| ES2528742T3 | Spain | T3 | |
| ES2529340T3 | Spain | T3 | |
| US2015094801A1 | United States of America | A1 | |
| CY1111861T1 | Cyprus | T1 | |
| US9216082B2 | United States of America | B2 | |
| CN102772273B | China | B |
Numbers
- Publication, DOCDB
- 2059192
- Publication, EPODOC
- PL2059192T
- Application
- 818037
- Application, DOCDB
- 07818037
- Application, EPODOC
- PL20070818037T
Titles2
- English
- STENT-VALVES FOR VALVE REPLACEMENT AND ASSOCIATED METHODS AND SYSTEMS FOR SURGERY
- Polish
- Zastawki stentowe do wymiany zastawki oraz powiązane sposoby i układy do operacji
Classification
- CPC, 34
- A61F2/2418
- A61M39/22
- A61F2/243
- A61F2/2433
- A61F2/2472
- A61F2250/006
- A61F2220/0016
- A61F2220/0075
- A61F2220/0083
- A61F2230/0013
- A61F2230/0067
- A61F2230/0078
- A61F2/90
- A61F2/966
- A61F2002/9511
- A61F2210/0042
- A61F2250/001
- A61F2250/0039
- A61F2002/9505
- A61F2002/9665
- A61F2210/0014
- A61F2/2436
- A61F2/9522
- A61B17/12031
- A61B17/12131
- A61B2017/00606
- A61B2017/00623
- A61B2017/12095
- A61B17/0057
- A61F2/82
- A61F2/2427
- A61F2002/9534
- A61F2220/0033
- A61F2230/001
- IPC, 1
- A61F2 24