Stent-valve delivery system
Abstract
The present invention relates to stent valves (for example, single stent valves and double stent valves) and associated methods and systems and delivery thereof by means of minimally invasive surgery.

Term
0.9 yearsleft in the term
Expires 23 August 2027.
- Priority
- Filed
- Granted
- Today
- Expires
19 claims: 1 independent, 18 dependent
- 1REIVINDICAÇÕES 1. Sistema de envio de stent-válvula cardíaca compreendendo:um primeiro conjunto compreendendo uma bainha externa e um tubo de fio guia;e um segundo conjunto compreendendo um suporte de 5 stent configurado para fixação removível a pelo menos um elemento de fixação de um stent-válvula, o stent-válvula posicionado sobre o tubo de fio guia do primeiro conjunto, em que o primeiro conjunto e o segundo conjunto são configurados para movimento relativo um com relação ao outro de modo a fazer a 10 transição a partir de uma posição fechada para uma posição aberta, de modo que na posição fechada a bainha externa engloba o stent-válvula ainda fixado ao suporte de stent e assim restringe a expansão do stent-válvula, e de modo que na posição aberta a bainha externa não restringe a expansão do stent-válvula e assim o stent-válvula se destaca a partir do suporte de 15 stent e se expande para uma configuração completamente expandida.
- 2Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que o primeiro conjunto e o segundo conjunto são configurados para fazer a transição a partir da posição fechada, para uma posição parcialmente aberta, para a posição aberta, em que na posição parcialmente a20 berta, o stent-válvula se expande parcial proximalmente mas não se destaca a partir do suporte de stent pelo fato de que a bainha externa ainda engloba pelo menos um elemento de fixação do stent-válvula e o suporte de stent.
- 3Sistema de envio de stent-válvula, de acordo com a reivindicação 2, adicionalmente compreendendo um mecanismo de enxágue. 25
- 4Sistema de envio de stent-válvula, de acordo com a reivindicação 1, adicionalmente compreendendo pelo menos um balão configurado para ocasionar pelo menos uma valvuloplastia antes da implantação do stent-válvula e expansão ou pós-dilatação do stent-válvula com a inflação do pelo menos um balão. 30
- 5Sistema de envio de stent-válvula, de acordo com a reivindicação 4, em que pelo menos um balão é alojado proximalmente ao stentválvula.
- 6Sistema de envio de stent-válvula, de acordo com a reivindicação 4, em que pelo menos um balão é alojado distalmente ao stentválvula.
- 7Sistema de envio de stent-válvula, de acordo com a reivindicação 4, em que pelo menos um balão é alojado pelo menos parcialmente dentro do stent valve.
- 8Sistema de envio de stent-válvula, de acordo com a reivindicação 1, adicionalmente compreendendo uma haste de impulsão para promover o movimento relativo do primeiro conjunto e o segundo conjunto.
- 9Sistema de envio de stent-válvula, de acordo com a reivindicação 1, adicionalmente compreendendo um mecanismo de parafuso para transmitir o movimento rotacional da haste em movimento relativo do primeiro conjunto e com segundo conjunto.
- 10Sistema de envio de stent-válvula, de acordo com a reivindicação 1, adicionalmente compreendendo um introdutor integrado no interior do qual o primeiro conjunto e o segundo conjunto são posicionados durante o envio do stent-válvula a um campo de implantação, em que o introdutor integrado é configurado para permanecer dentro do corpo do paciente após o primeiro conjunto e o segundo conjunto serem removidos.
- 11Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que após a expansão do stent-válvula para a configuração completamente expandida, o sistema de envio é configurado para retornar para a posição fechada ao passar o segundo conjunto através do stentválvula em direção da extremidade distai do primeiro conjunto.
- 12Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que pelo menos um elemento de fixação do stent-válvula compreende uma abertura geométrica configurada para fixação removível a uma estrutura complementar do suporte de stent.
- 13Sistema de envio de stent-válvula, de acordo com a reivindicação 12, em que a abertura geométrica compreende uma abertura circular ou oval.
- 14Sistema de envio de stent-válvula, de acordo com a reivindi3 cação 1, em que pelo menos um elemento de fixação do stent-válvula compreende um fio, gancho, ou tira configurado para fixação removível a uma estrutura complementar do suporte de stent.
- 15Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que pelo menos um elemento de fixação do stent-válvula compreende pelo menos dois elementos de fixação configurado para fixação removível ao número correspondente de estruturas complementares do suporte de stent.
- 16Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que pelo menos um elemento de fixação do stent-válvula compreende pelo menos três elementos de fixação configurados para fixação removível ao número correspondente de estruturas complementares do suporte de stent.
- 17Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que pelo menos um elemento de fixação do stent-válvula compreende pelo menos seis elementos de fixação configurados para fixação removível ao número correspondente de estruturas complementares do suporte de stent.
- 18Sistema de envio de stent-válvula, de acordo com a reivindicação 1, em que o stent-válvula compreende uma estrutura de treliça compreendendo:pelo menos uma coluna comissural;e o pelo menos um elemento de fixação.
- 19Sistema de envio de stent-válvula, de acordo com a reivindicação 18, em que a estrutura de treliça do stent-válvula adicionalmente compreende pelo menos um elemento de suporte para conectar pelo menos uma coluna comissural ao pelo menos um elemento de fixação.
Independent claims19
118 paragraphs, as filed
(54) Title: STENT-HEART VALVE SENDING SYSTEM (30) Unionist Priority: 12/21/2006 us 11 / 700,922, 7/7/2006 US 60 / 843,181 (73) Holder (s): Symetis sa (72 ) Inventor (s): Stéphane Delaloye (74) Attorney (s): Dannemann, Siemsen, Bigler & Ipanema Moreira (57) Summary: CARDIAC stent-valve delivery system. The present invention relates to stent valves (for example, single stent valves and double stent valves) and associated methods and systems and delivery thereof by means of minimally invasive surgery.
(86) International application: pct EP20070074i3de23 / 08/2007 (87) International publication: wo2008 / 028569de 13/03/2008
ΡΙ0722366 -8
l.
Descriptive Report of the Invention Patent for the STENT-HEART VALVE SHIPMENT SYSTEM.
Divided from PI0716544-7, deposited on 08/23/2007.
Field of the present invention
The present invention relates to stent valves and associated methods and systems for sending them by means of minimally invasive surgery.
Background of the present invention
Conventional approaches to replacing a heart valve require cutting a relatively large opening in the patient's sternum (sternotomy) or chest cavity (thoracotomy) to allow the surgeon to access the patient's heart. In addition, these approaches require the patient's heart to be stopped and a cardiopulmonary bypass (that is, use of a heart-lung bypass machine to oxygenate and circulate the patient's blood). Despite their invasiveness, these surgical approaches can be reasonably safe for a first intervention. However, tissue adhesions resulting from the first surgery may increase the risks (for example, death) associated with subsequent valve replacement surgeries. See Akins et al., Risk of Reoperative valve replacement for Failed Mitral and Aortic Bioprostheses, Ann Thorac Surg 1998; 65: 1545 - 52; and Weerasinghe et al., First Redo Heart valve replacement - A 10-Year Analysis, Circulation 1999; 99: 655 - 658; each of which is incorporated herein by reference into<sub>ç</sub>its entirety.
Synthetic valves and biological valves have been used to replace heart valves with variable results. Synthetic valves rarely fail but require long-term anticoagulant treatment to prevent blood from clotting (thrombosis) in and around the replacement valve. Said anticoagulant treatment significantly limits the patient's activities and can cause several other complications. Biological valves do not require such anticoagulant treatment but typically fail within 10-15 years. Thus, to limit the need for and the risks associated with reoperation on failed biological valves, traditionally only patients less than about 10-15 years old have received replacement biological valves. Patients with a longer life expectancy received synthetic valves and anticoagulant treatment.
Attempts have been made to develop less invasive surgical methods for heart valve replacement. Said surgical methods, referred to as percutaneous cardiac valve replacement therapies (PHVT), use a catheter to send the replacement valve to an implantation field using the patient's vascular system. Said attempts at PHVT present several drawbacks, including its inability to ensure proper positioning and stability of the replacement valve within the patient's body.
In view of the above, it should be desirable to provide improved methods, systems, and devices for heart valve replacement.
Summary of the invention
Some embodiments of the present invention are directed to systems, methods, and devices for replacing a heart valve. For example, said methods, systems, and devices may be applicable for the wide range of heart valve therapies including replacement of failed aortic, mitral, tricuspid and pulmonary valves. In some embodiments, the present invention can facilitate a surgical approach with which surgery is performed on a beating heart without the need for an open chest cavity and cardiopulmonary bypass. This minimally invasive approach can reduce the risks associated with replacing a failed native valve in the first instance, as well as the risks associated with secondary or subsequent surgeries to replace failed artificial valves (for example, biological or synthetic).
Stent valves according to some embodiments of the present invention can include a valve component and at least one stent component. The valve component may include a biological or synthetic (e.g., mechanical) valve and / or any other suitable material (s). The stent component may include a first section (for example, a proximal section), a second section configured to house the valve component, and a third section (for example, distal section). The stent and valve components may be capable of at least two configurations: a collapse configuration (for example, during shipment) and an expanded configuration (for example, after implantation).
In some embodiments, the first section of the stent valve may include a fastener. Said fastening member can include, for example, an annular groove to hold the stent valve in place in an implantation field. When the stent valve includes a single stent (single stent valve), the annular groove can be configured to receive the valve ring in need of replacement. When the stent valve includes two stents (double stent valve), the annular groove of the first stent component can be configured by fixing corresponding to a complementary annular projection of a second stent component (i.e., a positioning stent). In turn, the second stent component can be anchored in the implantation field, for example, in the valve in need of replacement and / or attached structures.
Alternatively or additionally, in some embodiments, the third section of the stent component may include at least one fixation element. Each stent valve fixing element may include, for example, a geometric opening (e.g., circular or oval), hook, or strip configured to be removably attached to a complementary structure of a shipping device. In addition, each fixation element can correspond to all or a portion of a commissural column, to which the commissure between two valvular follicles can be fixed. The fixture (s) may allow the stent valve to be partially expanded within the patient's body while the stent valve remains attached to the delivery device. This can allow the stent valve to be returned to a collapsed configuration and repositioned within the patient's body when it is determined that the full expansion of the stent valve would cause the stent valve to be installed incorrectly. Alternatively or in addition, this may allow the stent valve to be returned to the collapsed configuration and removed from the patient's body when it is determined that the stent valve is not functioning properly (for example, not allowing sufficient flow). In some embodiments, the stent valve may include a fixture. In other embodiments, the stent valve can include at least two, three, six, or any other suitable number of fasteners. In some embodiments, the diameter of the fully expanded stent in the region of the fastener (s) may be smaller than the diameter of the region that houses an associated valve. This can reduce the risk of damage to the patient's body (e.g., perforation of the aorta) from the fasteners and / or make it easier to fasten the fasteners to the complementary structure of the sending device.
In some embodiments, the stent component of a stent valve may include a truss structure with a plurality of cells. The truss structure can be formed from, for example, a shaped memory alloy such as nitinol or any other suitable material (s). The cells in the truss structure may be more densely popular in the section of the stent component that includes the fastener. This can provide additional support for the fastener and increase the stability of a stent valve. In some embodiments, the truss structure can form at least one rod along (for example, commissural column) that extends distally along the stent component towards at least one fixture. At least one rod can connect directly to at least one fastener. Alternatively, the truss structure can form at least one support element to connect at least one rod to at least one fixture. In some embodiments, all cells in the truss structure can be closed cells, which can facilitate the recapture of a stent valve from a partially expanded configuration to a collapsed configuration.
Still other embodiments of the present invention are directed to a method for replacing a valve. A stent valve is provided which includes a stent component with an annular groove, and the stent valve is axially attached to a valve ring in need of replacement. In some embodiments, providing a stent valve may include suturing a valve component to the stent component. Alternatively or additionally, providing a stent valve may include expanding a valve component within the stent component to form a friction fit. In some embodiments, proposing10 a stent valve may include attaching a valve component to the stent component with a hook and loop fastening system (for example, VELCRO®).
In other embodiments of the present invention, a method for replacing a valve is provided according to which a first stent component that includes an annular element is implanted so that at least a portion of the first stent component is housed within a valve in need of replacement. A stent valve that includes a second stent component is positioned within the first stent component by corresponding attachment of an annular element complementary to the second stent component to the annular element of the first stent component.
In still other embodiments of the present invention, a stent valve delivery system is provided. A first set is provided that includes an outer sheath and a guide wire tube. The shipping system also includes a second set including a stent bracket configured to be removably attached to at least one stent valve fixture. The stent valve can be positioned on the guide wire of the first set. The first set and the second set can be configured to move relative to each other in order to pass from a closed position to an open position. In the closed position, the outer sheath can encompass the stent valve still attached to the stent holder and thus restrict the expansion of a stent valve. In the open position, the outer sheath may not restrict the expansion of a stent valve, so the stent valve can detach from the stent holder and expand to a fully expanded configuration.
In some embodiments, the first set and the second set can be configured to move from a closed position, to a partially open position, to an open position. In the partially open position, the stent valve can expand partially but not protrude from the stent support due to the fact that the outer sheath can still comprise at least one fixing element of a stent valve and the stent support. When the stent valve is in the partially expanded configuration, it can be determined whether the stent valve will be correctly positioned if the stent valve is expanded to a fully expanded configuration. Alternatively or in addition, the functionality of a stent valve can be tested (for example, to determine whether the stent valve will allow sufficient blood flow) when the stent valve is in the partially expanded configuration.
In some embodiments, the stent valve delivery system may include at least one balloon (for example, proximal to the stent valve or another stent to be shipped) configured to promote the expansion of a stent valve or position the stent with the inflation of at least one balloon.
In some embodiments, the stent valve delivery system may include a push rod which causes the relative movement of the first and second sets. Alternatively, the stent valve delivery system may include a screw mechanism for passing the rotational movement of a stem to the relative movement of the first and second assemblies.
In some embodiments, the stent valve delivery system may include an integrated introducer within which the first set and the second set are positioned when sending a stent valve to an implantation field. The integrated introducer can be configured to remain inside the patient's body even after the first set and the second set have been removed, for example, to allow the introduction of an occluder.
In some embodiments, after expanding a stent valve to a fully expanded configuration, the delivery system can be configured to return to a closed position by passing the second set through a stent valve towards the distal end of the first set .
Still other embodiments of the present invention are directed to a method for sending a stent valve to an implantation field according to which the stent valve is removably attached to a delivery device and the stent valve is sent to a deployment field in a collapse configuration. The stent valve can be partially expanded while keeping the stent valve attached to the shipping device. A determination with respect to the stent valve can be performed when the stent valve is in the partially expanded configuration. When the determination produces a positive response, the stent valve can be expanded to its fully expanded configuration by causing the stent valve to pop out from the delivery device.
In a particular embodiment, it can be determined whether the stent valve is correctly positioned in the implantation field. The stent valve can be returned to a collapsed configuration and repositioned when the stent valve is not correctly positioned in the implantation field.
Alternatively or in addition, it can be determined whether a valve component of a stent valve is functioning properly, for example, by testing whether the valve component will allow sufficient blood flow. The stent valve can be returned to a collapsed configuration and removed from the patient's body when the stent valve is not functioning properly.
In some embodiments, sending the stent valve to an implantation field may include sending the stent valve to the heart to replace a heart valve. Sending may include accessing the patient's body through an intercostal space (for example, fifth intercostal space) and penetrating the left ventricle at the apex of the heart.
Brief Description of Drawings
For a better understanding of the present invention, reference is made to the following description, taken in conjunction with the accompanying drawings, in which similar reference characters refer to similar parts throughout, and in which:
figure 1A shows a valve component in an expanded configuration according to some embodiments of the present invention;
figure 1B shows a valve component in a collapsed configuration according to some embodiments of the present invention;
figure 2A shows a stent component in an expanded configuration according to some embodiments of the present invention;
Figure 2B shows a single stent valve, which includes a stent component and a valve component, in an expanded configuration according to some embodiments of the present invention;
Figure 2C shows a single stent valve in a collapsed configuration according to some embodiments of the present invention;
figure 3A shows a stent component in an expanded configuration according to some embodiments of the present invention;
figure 3B shows a stent component in a collapse configuration according to some embodiments of the present invention;
figure 4 shows the double stent valve, which includes two stent components and a valve component, in an expanded configuration according to some embodiments of the present invention;
figures 5A - 7B illustrate the use of a single stent valve to replace a failed biological (artificial) valve according to some embodiments of the present invention;
figures 8A and 8B show a stent component that includes fasteners for securing the stent to a delivery device and fasteners for securing the stent in the implantation field according to some embodiments of the present invention;
Figure 8C shows a stent component having a diameter in the region of the fastener (s) that is smaller than the diameter of a stent region that houses an associated valve, according to some embodiments of the present invention;
figure 8D shows a stent component that includes independently foldable element (s) for use in positioning / securing the stent to geometry / topology in an implantation field in accordance with some embodiments of the present invention;
figure 8E shows a stent component that includes locking elements in a crown configuration and a fixing element for securing the stent in an implantation field in accordance with some embodiments of the present invention;
Figure 8F shows a stent component that includes multiple bars for carrying a valve component more closely to a region of the stent component that includes fixing element (s) for securing the stent component to a delivery device;
figures 9A - 16 show additional modalities of stent components which include fasteners for securing the stent to a delivery device and / or fasteners for securing the stent in the implantation field according to the present invention;
figures 17/18, 19, and 20 show additional examples of double stent valves according to some embodiments of the present invention;
figure 21A shows a stent valve in the shape of an opposing double crown in accordance with some embodiments of the present invention;
figures 21B - E show views of a double-conical stent according to some embodiments of the present invention;
figures 22A - 22D show a delivery system for sending a self-expanding stent valve to an implantation field in accordance with some embodiments of the present invention;
figures 23A - 23D show a delivery system with inflatable balloon (s) according to some embodiments of the present invention;
figures 24A - 24D show a delivery system provided with a proximal external axis with a larger diameter according to some embodiments of the present invention;
figures 25A - 25C show a delivery system with inflatable balloon (s) according to some embodiments of the present invention;
figures 26A - 26C show a delivery system with an integrated introducer according to some embodiments of the present invention;
figure 27 is a flow chart of illustrative stages involved in replacing a failed native or artificial valve according to some embodiments of the present invention; and figures 28A - C illustrate a replacement of a failed valve using a delivery system in accordance with some embodiments of the present invention.
Detailed Description of the Invention
Figures 1A - 3B show components 100, 200, and 300 for use in replacing, for example, an aortic valve (eg, degenerate), mitral valve, or failed pulmonary heart valve (eg, in a pediatric patient) of according to some embodiments of the present invention. More particularly, figures 1A and 1B show a valve component 100. figures 2A - 2C show a stent component 200 for housing valve component 100. figures 3A and 3B show a stent component 300 for housing stent component 200 and valve component 100. A device including components 100 and 200 can be referred to as a single stent valve. A device that additionally includes component 300 can be referred to as the double stent valve.
Figure 4 shows the double stent valve 400 which includes valve component 100, stent component 200, and stent component 300 according to some embodiments of the present invention. Double stent valve 400 can replace the failed native or artificial valve. As used here, a native valve refers to a valve naturally present within the patient's body. The failed native valve can be, for example, a stenotic valve. An artificial valve refers to a biological or synthetic (for example, mechanical) valve introduced into the patient's body through surgery. The implantation field for a device 400 (or other replacement valve) typically includes at least a part of the area within the failed valve and / or along at least a portion of adjacent structure (s). For example, to replace the failed aortic valve, device 400 can be implanted into the patient's body so that portion 402 of the device is positioned substantially entirely within the failed aortic valve. Portion 404 of device 400 may extend over at least a portion of the aorta. Portion 406 of device 400 may extend into at least a portion of the left ventricle of the patient's heart.
The double stent valve 400 can be shipped to an implantation field using any suitable shipping approach. In some embodiments of the present invention, device 400 may be substantially entirely assembled from components 100, 200, and 300 outside the patient's body before device 400 is sent to an implantation field. In other embodiments of the present invention, components 100, 200 and 300 of device 400 can be sent to an implantation field separately in multiple steps. For example, stent component 300 can be shipped and installed in the implantation field, followed by shipping and installing stent component 200 and valve component 100 in one or more separate steps. In one embodiment, components 100 and 200 can be mounted outside the patient's body and then shipped and installed inside component 300 at the same time. In another embodiment, stent component 200 can be shipped and installed within stent component 300, followed by shipping and installing valve component 100 in a separate step. Additional modalities of double stent valves are described with reference to figures 17-20.
In some embodiments of the present invention, the single stent valve (Figure 2B) that includes valve component 100 and stent component 200 (but not stent component 300) can be used to replace the failed native or artificial valve. For example, in a particular embodiment, the single stent valve can replace a failed biological valve introduced into the patient's body during a previous valve replacement surgery. Thus, the surgery involving the single stent valve shown in figure 2B can be secondary or subsequent valve replacement surgery. Although in this modality no new stent component 300 can be introduced into the patient's body, the single stent valve including components 100 and 200 can be housed by a stent and / or valve that remains in the implantation field from the previous surgery. valve replacement. In some embodiments, at least a portion of the stent and / or valve from the previous surgery can be removed before the single stent valve is installed in the implantation field. Additional details regarding the replacement of a failed biological valve with the single stent valve are described with reference to figures 5A-7B.
In some embodiments of the present invention, valve component 100 can be flexible and collapsible so that it can be collapsed, for example, during delivery via a catheter to an implantation field. Several modalities of delivery systems and surgical approaches for minimally invasive surgery are described below with respect to figures 22A - 26C. Upon delivery, the valve component can be at least partially expanded. Figure 1A is a perspective view of valve component 100 in an expanded configuration. Figure 1B is a perspective view of valve component 100 in a collapsed configuration. As used here, collapse configuration and expanded configuration refers to the relative difference, for example, in the diameter and / or any other physical characteristic (s) of a component (for example, length, width). For example, the collapsed valve component shown in figure 1B has a reduced diameter and may or may not be longer in length than the expanded valve component shown in figure 1A.
The valve component 100 may include a biological material (for example, tanned, non-tanned, non-tanned, heterologous or autologous material), a synthetic material (for example, polymer (s) such as polyurethane and / or silicon (s)), or a combination of them. In some embodiments, valve component 100 may include preserved biological tissue such as, for example, human tissue (e.g., homografts, valve tissue autografts) or animal tissue (valve tissue heterograft or xenograft). In some embodiments, the valve component 100 may be a mechanical valve. For example, when valve component 100 is a biological valve, expanding valve component 100 from a collapsed to an expanded configuration may require self-expansion of a fixed stent component 200. Differently, a valve component synthetic 100 may be capable of self-expansion. The valve component 100 can be provided with a shape / shape (for example, length, width, diameter, etc.) corresponding to that of the intended application of the valve (for example, tricuspid, pulmonary, mitral or aortic). In figures 1A and 1B, valve component 100 is a tricuspid valve with three cusps. This particular configuration may be particularly suitable, for example, for the replacement of the failed aortic valve. In other embodiments, valve component 100 may be provided with any other suitable number of cusps and / or other physical characteristics (for example, diameter, length, width, etc.).
Figure 2A is a perspective view of the stent component
200 according to an embodiment of the present invention. As shown in figure 2B, stent component 200 houses valve component 100. In some embodiments, at least a portion of stent component 200 can be substantially cylindrical in shape. Alternatively or additionally, the stent component 200 may be provided with an indentation (for example, annular groove) or another fixation element 202, for example, to fix the stent in place in the implantation field. For example, when the stent component 200 is part of the double stent valve 400 (figure 4), the fastener 202 can be fixed correspondingly to a complementary fastener 302 (for example, internal annular projection, figure 3 A) of the stent component 300. When the stent component 200 is part of a single stent valve (figure 2B), the fastener 202 can attach to at least a portion of the failed valve. Mo10 Additional features of stent components that may include fasteners are described with reference to figures 6A and 8A -16.
In some embodiments of the present invention, stent component 200, such as valve component 100, may be capable of at least two configurations: a first, collapsed configuration (for example, during shipment) and a second, expanded configuration ( for example, after installation). Figure 2A shows stent component 200 in an illustrative expanded configuration. Figure 2C shows the stent component 200 in an illustrative collapse configuration, with the collapsed valve component 100 housed therein, for example, for sending both components to an implantation field at the same time. In some embodiments, the stent component 200 can be produced from wire or can be laser cut from a tube, sheath, or the like. The stent component 200 may include an alloy of shaped memory material such as, for example, nitinol. The shape memory alloy can allow compression of the stent component 200 (and / or valve component 100) for the first configuration, for example, for delivery through a small opening in the patient's body and expansion of the stent component 200 for the second configuration during installation. Components 100 and / or 200 can be maintained in a collapsed configuration, for example, with a sheath or wrap. The sheath / wrap can be removed to allow components 100 and / or 200 to be reconfigured for the second configuration.
The valve component 100 can be attached to the stent component 200 by any suitable attachment mechanism or combination of attachment mechanisms. For example, in one embodiment, valve component 100 may be sutured with one or more stitches to stent component 200. In another embodiment, valve component 100 may be attached to stent component 200 by means of a friction fit. . For example, valve component 100 can be provided with a fully expanded diameter that is relatively larger than the expanded diameter of stent component 200 so that components 100 and 200 fit tightly together with expansion of component 100 within the component 200. In yet another embodiment, a hook and loop fixation system (for example, VELCRO®) can be used to attach valve component 100 to stent component 200. For example, stent component 200 may include microscopic hooks and valve component 100 may include corresponding microscopic loops (or vice versa). Said hook and loop fastening system may include a microvilli material, which was previously used for surgical applications to enhance inward growth. Said hook and loop fixing system can allow the position of the valve component 100 to be precisely tuned with respect to the position of the stent component 200, for example, after components 100 and 200 have been implanted in the patient's body. Hooks / loops can further facilitate blood clotting and the formation of a seal at the interface between valve component 100 and stent component 200. To avoid premature clot formation (for example, excessive clot formation before installation is complete), monitoring and / or treatment with anticoagulant can be provided to the patient. Reliable hook and loop connections can still be achieved in the presence of premature clot formation, although greater activation pressure (described below) may be required. A preliminary assessment shows that reliable hook and loop connections can be formed in the presence of water, jelly, liquid soap, and / or clotting proteins. In some instances, said hook and loop fixing system can be used, alternatively or additionally, to attach stent component 200 to stent component 300 (for example, with microscopic hooks attached to an external surface of the component of stent) stent 200 and the corresponding microscopic loops attached to an internal surface of the stent component 300, or vice versa).
Any suitable mechanism or combination of mechanisms (for example, exerting direct or indirect mechanical compression) can be used to provide the activation pressure necessary to make the micro-hooks attach to the micro loops. For example, in some embodiments, one or more balloons can be positioned adjacent to valve component 100 and / or stent component 200 (for example, within valve component 100) and temporarily inflated to bring the micro-hooks into contact with the micro-handles . The said balloon (s) may be disposed within the valve component 100 and / or stent component 200 subsequent to the delivery of the stent and / or valve to an implantation field. Alternatively, in some embodiments the balloon (s) can be mounted (for example, removably mounted) within valve component 100 and / or stent component 200 prior to sending the stent and / or valve to a implantation field (for example, before loading the stent and / or valve into a shipping device). The use of said balloon (s) is not limited to the modalities in which the valve and stent are attached to each other by means of hooks / loops. Instead, said balloon (s) can be used whenever it is necessary or desirable to use the balloon (s) to assist in expansion and / or engagement in the stent and / or valve implantation field (for example , when the valve is sutured to the stent). In some embodiments, a self-expanding valve component 100 can be provided that self-expands within the stent component 200 in order to cause the micro-hooks to contact the micro-handles.
Figure 3A is a perspective view of the stent component
300 according to an embodiment of the present invention. As described above, the stent component 300 may be provided with a fixation element 302 (e.g., internal annular projection) which corresponds correspondingly to a complementary fixation element 202 of the stent component 200 (figure 2A). Figure 4 shows an embodiment of said corresponding fixation, in which component 300 houses both components 100 and 200 to form double stent valve 400. The geometry (e.g., length, width (s), diameter (s), etc.) of the stent component 300 may be particularly suitable, for example, for replacement of aortic valve. In other embodiments, other geometries and configurations of the stent component 300 may be provided.
The stent component 300 can be secured in place in the implantation field using any suitable attachment mechanism or combination of attachment mechanisms. For example, in some embodiments, the fixture 302 can form a recess (e.g., outer annular groove) to receive at least a portion of the failed valve. In some embodiments, the stent component 300 may be provided with a relatively larger diameter than a diameter of the implantation field so that the delivery and expansion of the stent component 300 in the implantation field stent component 300 in place by through a friction fitting. In some embodiments, the stent component 300 may include one or more projections (e.g., nipples) or clamps for anchoring the stent component 300 to the failed valve and / or adjacent structure (s) in the implantation field.
Figures 5A - 7B illustrate modalities of the present invention for the replacement of a failed artificial (e.g., biological) valve (e.g., stent valve) introduced to the patient's body during a previous surgery. Figure 5A is a perspective view of a failed biological valve 500 where the valve cusps 502 fail to close. Figure 5B is a perspective view of the failed biological valve 500 after implantation of a stent valve shown in figure 2B. As shown, the failed biological valve 500 (for example, and / or its accompanying stent) holds the new stent valve in place in the implantation field. More particularly, the fastening element 202 of a stent valve (figures
2Α and 2B), which can be an annular groove forming the narrowest portion of a stent valve, can receive the failed biological valve ring 500 thereby securing the stent valve in place. In other embodiments of the present invention, at least one portion of the failed biological valve 500 can be removed from the patient's body (e.g., the failed valve itself), while other portion (s) of the failed valve can be removed. be left behind in the implantation field (for example, a support stent). In still other embodiments, the failed biological valve 500 including all of its associated components can be substantially removed entirely from the implantation field prior to installation of the new stent valve.
Figure 6A is a perspective view of another example of a stent valve 600 according to an embodiment of the present invention. Figure 6B is a perspective view showing the use of stent valve 600 to replace a failed artificial (for example, biological) valve. Stent valve 600 includes one or more (e.g., three) locking or retaining elements 602 along an external surface of the stent component. Each locking element 602 can include directionality so that the same collapse (for example, flush with an external surface of the stent component) with the locking element engaging with another surface (for example, the inside of a catheter) . When the locking element 602 protrudes from the external surface of the stent component, the first end 604 of the locking element can be adjacent to the external surface of the stent component, while the second end 606 of the locking component can be spaced apart. from the external surface of the stent component. When multiple locking elements 602 are provided, the first ends 604 of all locking elements can be positioned at substantially the same height / vertical position along the central axis of the stent component (for example, evenly dispersed around the perimeter of the stent component), and the second ends 606 can be positioned at different heights (s) / vertical position (S) than the first ends 604. The first end 604 can be flexible (for example, allow movement similar to the joint in two dimensions) so that the movement of the second end with respect to the external surface of the stent component does not impair the locking mechanism.
In some embodiments of the present invention, stent valve 600 can be inserted into the failed valve in the direction of arrow 608 in figure 6B. When the first end 604 of each locking element 602 meets the inner diameter / ring of the failed valve, the second end 606 of the locking element may collapse towards the outer surface of the stent component. With the second end 606 of the locking element reaching an open area of the failed valve, the second end can project outward, locking the stent valve 600 in place. Thus, the locking elements 602 can provide a mechanism for securing the new stent valve in place, as an alternative to or in addition to the fixing element 610 (e.g. annular groove) of the stent component for securing the stent valve. 600 to (for example) the failed valve ring.
Figures 7A and 7B show another embodiment of a stent component 700 with locking elements in accordance with the present invention. Figure 7A shows that said stent component can be produced, for example, from a sheet of suitable material (for example, nitinol). With reference to figure 7B, stent component 700 includes one or more locking elements 702 that extend radially from an external surface of the stent component so that, for each locking element, the first end 704 and the second end 706 of that locking element is provided with substantially the same vertical position / height along the central axis of the stent component. In other embodiments, said locking elements can be relatively angled, so that the ends 704 and 706 of the same locking element are provided with different relative positions / vertical heights along the central axis of the stent component. In some embodiments, a stent component may be provided which includes multiple locking elements, with each locking element provided with ends 704 and 706 with different angular orientations. Different locking elements 702 can be provided with the same or different vertical positions / heights along the central axis of the stent component.
Figures 8A - 16 show additional examples of stent components suitable for use in valve replacement according to some embodiments of the present invention. Said stent components can be used, for example, as part of single stent valves and double stent valves. Each of said stent components includes one or more fasteners for removably securing the stent component (for example, together with an integrated valve component) to a shipping device (figures 22 - 26). In some embodiments, said stent components may further include a fixation element (for example, similar to fixation element 202 (figure 2A)) for fixing the stent component in place in the implantation field.
Figure 8A shows a perspective view of a stent component 800 in a collapsed configuration, as well as a sectional view of the stent component 800 that illustrates details regarding its structure. Figure 8B shows the stent component 800 in an expanded configuration. The stent component 800 includes the first section (for example, proximal) 802 that includes a fixing element (for example, annular groove), the second section 804 that can follow the contour of a valve component to be housed therein, and third section (for example, distal) 806 that includes one or more (for example, three) fasteners 808. In some embodiments, the stent component 800 may include (for example) a lattice structure (for example, formed from a nitinol wire), for example, with section 802 endowed with a denser population of lattice cells than section 804 and / or section 806. This can provide additional support for the fastening element in section 802 and therefore increase the stability of device 800 in the implantation field. In some embodiments, the stent component 800 may include only closed lattice cells in order to facilitate the recapture of the stent component 800 by a shipping device when the stent component 800 is in the partially expanded configuration (described below).
In some embodiments, each of the fastening elements 808 may include an opening (for example, circular or oval) for removably securing the stent component 800 to a complementary element (for example, wire, strip or hook) of a device shipping. Fixing elements 808 may allow partial expansion of the stent component (for example, together with an integrated valve component and / or another stent component) within the patient's body while causing the stent component to remain attached to the delivery system. send. For example, sections 802 and 804 (for example, and part of section 806) of the stent component 800 can expand when the stent component 800 is partially released from the axis during shipment, while no changes can be observed at relative positions of the fastening elements 808 still constrained by the shaft (for example, see figure 28 partial release). This may allow a surgeon to reposition and / or test the functionality of a stent valve (or double stent valve) within the patient's body before finalizing the application of a stent valve in the implantation field. Such a test of valve functionality may include monitoring of the peripheral pulse, according to which the pulse wave is measurable if the valve is functioning properly. A more reliable assessment of stent valve function can be implemented with transesophageal echocardiography (TEE), intravascular ultrasound (IVUS) and / or intracardiac echocardiography (ECI). If the stent valve malfunctions during the test (for example, if the valve does not allow sufficient blood flow), the stent valve can be completely recaptured by the delivery device and removed from the patient's body. In other embodiments, the stent component 800 can be provided with a different truss structure, the fastening elements 808 can be reduced or enlarged in length and / or other dimension (s), and / or the fastening elements 808 can be included in other locations.relating to the stent component 800 (for example, within section 804).
Figure 8C shows another embodiment of a stent component with integrated fasteners 814 that are configured so that the diameter fully expanded in the region of the fastener (s) is less than the diameter of the region that houses an associated valve. As shown in said example, the fastener partially protrudes inwardly towards the central axis of the stent component. This can reduce the risk of damage to the patient's body (eg, perforation of the aorta) from the fasteners. Alternatively or in addition, this can make it easier to attach the fastening elements to a complementary structure of the sending device. For example, when the device is attached for fixing to the delivery device, the reduced diameter in the region of the fasteners can cause the fasteners to engage the stent holder earlier.
Figure 8D shows yet another embodiment of a stent component according to the present invention. In this embodiment, the first (proximal) section of the stent includes 27 folding and independent elements 816, each of which may include connected and / or disconnected cells (s) which can be opened and / or closed. In this embodiment, each folding element includes a single closed cell. In other embodiments, other number (s) and / or configuration (s) of the foldable elements may be provided. The 816 folding elements allow to precisely position / secure the stent section proximal to the geometry / topology of (for example) a calcified ring / failed biological valve. Each element 816 can independently fold / adapt to the topology of the immediately adjacent portion of the calcified ring / failed biological valve. Foldable elements 816 collectively form an annular groove in which the location of the fold deformation (grooved portion) for each foldable element is controlled by reducing or lengthening the lengths of a fixed pair of stent brackets (818, 820) which act as a joint. The length of a single stent holder is shown by the numeral 822. Basically, the radial strength / resistance of each folding element 816 is influenced by the selection of an angle 824 during the manufacture of the stent. Other design parameters such as thickness / width of the support also influence the radial force. An advantage of this configuration is that the proximal section of the stent can more adequately anchor the stent in place in the implantation field regardless of the median section of the stent. Thus, the median section of the stent can be designed to accommodate (for example) the aortic valve without any oversizing, thus reducing the risk of valve failure due to long-term mechanical stress. The stent in Figure 8D also includes a compensating element 826 (for example, including a triangular wave portion and two elongated arms) to accommodate elongation divergences (if any) within the stent during fabrication and / or crimping. In contrast, figure 8D with the modality shown in figure 8C, in which the absence of dedicated pairs of supports prevents the proximal section of the stent from being provided with elements that bend independently (for example, during implantation).
Figure 8E shows another embodiment of a stent component according to the present invention. In figure 8E, only about 1/3 of a sectional view of the stent component is shown in order to more clearly show its characteristics. Similar to the locking / retaining elements 602 shown in figures 6A and 6B, the stent component shown in figure 8E includes a plurality of independently foldable locking elements 828 generally located within the region of the stent component referred to as region 804 in the figure 8B. Locking elements 828 form a crown that can engage, for example, a failed biological valve or native calcified ring from the outflow side. The stent component in figure 8E also includes a fixture 830 (for example, annular groove). In figure 8E, locking elements 828 are shown to be positioned at substantially the same position / height along the central axis of the stent component. In other embodiments, different locking elements 828 can be provided with the same or different vertical positions / heights along the central axis of the stent component similar, for example, to the stent shown in figure 7B. By having different positions / heights for at least some of the locking elements 828 you can facilitate the engagement with, for example, native valves of different sizes (for example, a thin native valve that can be engaged by the locking elements separated by a small distance or a thick native valve that can only be engaged by more distantly spaced locking elements).
Figure 8F shows another embodiment of a stent component according to the present invention. In figure 8F, only about 1/3 of a sectional view of the stent component is shown in order to more clearly show its characteristics. Figure 8F includes a Dacron 832 Pocket to accommodate a valve component, where the Dacron 832 pocket is sutured along the free edge of the 834 valve. As shown, the valve component inside pocket 832 is housed more closely to the fastening element (s) 836, which are similar to the fastening elements 808 in figure 8B, in the embodiment of figure 8F than in an embodiment shown in figure 9C. An inverted U-shaped support 838 is slid into the pocket of Dacron 832. The valve / pocket is sutured to an inverted U-shaped support 840. Internal U-shaped support 842 is positioned outside the pocket of Dacron 832 and serves as a slider during load / release / recapture of the implant with a sending device by reducing the frictional forces between the pocket of Dacron 832 and the outer sheath. The internal U-shaped support 842 can also be sutured to the pocket of Dacron 832. In some embodiments, the pocket of Dacron 832 can be closed with additional stitches 844. Although the bottom portion of the stent is not shown in Figure 8F, in some embodiments it may include, for example, a fastener (e.g., annular groove) similar to the fastener 802 in Figure 8B.
Figures 9A - 9C show another example of a stent component 900 with integrated fastening member (s) 902 according to an embodiment of the present invention. Figure 9A shows a perspective view of the stent component 900 in a collapsed configuration, as well as a sectional view of the stent component 900 that illustrates details relating to its structure. Figure 9B is a perspective view of the stent component 900 in an expanded configuration. Figure 9C shows the stent component 900 (with an integrated valve component) positioned under a rule to show its size (for example, about 4 centimeters). As shown, each of the fasteners 902 includes a circular or oval opening attached to the stent component 900 by two support elements 904 (e.g., wires). In turn, each pair of support elements 904 attaches to the stem 906 (e.g., commissural column) within a truss structure. In a different way, each of the fastening elements 808 in figure 8B is fixed to the stent component 800 by a single support element 810, and each support element 810 is fixed to the rod 812. All stent components shown in Figures 8A - 16 include three rods, although it is understood that other suitable numbers of rods or no rod (for example, Figure 2A) can be provided according to some embodiments of the present invention. The stent component 900 also includes a fastener 908, which can be substantially similar to fastener 202 (figure 2A). In the embodiment of figure 9C, the valve component is sutured around the circumference of its ring. Each of the three cusps of the valve component is also stitched to the stent to allow valve functionality. Suture locations can be selected to allow elongation of the stent during curling without damaging the valve or suture. For example, the inlet flow of the stent (for example, within the region 802 shown in figure 8B) can be covered on the inside with tissue (for example, mesh). The tissue and valve component can be sutured to the stent (for example, using a slide and / or interrupted technique) in the region adjacent to the annular groove (for example, along the edge of the 802 and 804 stent sections in figure 8B ). Some excess tissue on the inward flow side can be folded over the outer side of the stent and sutured together with the valve component in the vicinity of (for example, forward towards section 804) the anterior suture site. The commissures of the valve components can also be attached to the corresponding stent columns, which may have previously been covered with tissue (for example,
Dacron). Alternatively, pericardium or other suitable material can be used to cover the stent component. In some embodiments, the valve component may be a porcine valve component that can be collected as such or assembled from several donors in order to be provided with an optimal match between three cusps. Bovine and equine valves can also be used which are produced from pericardium. Other sources of suitable valve components can also be used.
Figures 10A - 10B show yet another example of a stent component 1000 with integrated fixing element (s) 1002 according to an embodiment of the present invention. Figure 10A shows a perspective view of the stent component 1000 in a collapsed configuration, as well as a sectional view of the stent component 1000 that illustrates details relating to its structure. Figure 10B is a perspective view of the stent component 1000 in an expanded configuration. As shown, at least one pair (for example, all pairs) of fasteners 1002 are attached to one another with a reinforcement element 1004. Each reinforcement element 1004 can be attached at one end to the first fastener 1002 and at the other end to the second fastener 1002. In some embodiments, the reinforcement element (s) 1004 may include a wire configured as a triangular wave. When all fasteners 1002 include a reinforcement element 1004, collectively reinforcement elements 1004 can form a circle around the perimeter of stent component 1000. Stent component 1000 can be substantially the same as stent component 800 (figure 8B) in relation to all other things.
Figures 11-16 show additional examples of stent components with integrated fastener (s) in accordance with some of the embodiments of the present invention. Figures 11-16 each include a perspective view of a stent component in a collapsed configuration, as well as a sectional view of the stent component that illustrates details relating to its structure. The following description summarizes the various characteristics of the stent components shown in figures 11 - 16. Additional structural characteristics of the modalities shown in figures 8A - 16 will be apparent from those skilled in the art from the drawings.
Figure 11 shows a stent component that includes a shorter support member (s) to attach to a corresponding number of oval / circular fixation member (s) (i.e., shorter compared to support elements 810) of figure 8B). The rod (s) in figure 11 for attachment to the support elements can be substantially the same as the rods 906 in figure 9B.
Figure 12 shows a stent component that includes two support elements for attachment to each oval / circular fixation element. Each pair of support elements attaches to a rod so that collectively the support and rod elements form a second oval / circular opening, for example, for additional support and / or for use as an additional or alternative fastener. The rod (s) in figure 12 can be substantially the same as the rods 906 in figure 9B.
Figure 13 shows a stent component that includes non-circular / oval fasteners such as, for example, wires, hooks, strips, or a combination of them to fasten correspondingly to the complementary element of a shipping device (for example , a circular or oval opening). The stent component in figure 13 also includes a greater number of fasteners (for example, six) when compared to the number of fasteners (for example, three) of stent component 900 (figures 9A and 9B). In figure 13, the fastening elements are directly attached to the stent component's rods, two fasteners per rod. The rod (s) in figure 13 can be substantially the same as the rods 906 in figure 9B.
Figure 14 shows a stent component that replaces the wire / hook fasteners in Figure 13 with long, narrow openings (for example, long and narrow compared to the fasteners 902 of Figure 9A). The rod (s) in figure 14 can be substantially the same as the rods 906 in figure 9B.
Figure 15 shows a stent component with a modified truss structure, including a stem structure. The stent component in figure 15 also includes circular / oval fasteners, where each fastener is attached to a rod by two support elements. Each pair of support elements and corresponding rod can form a second circular / oval opening, similar to the configuration of the support / rod element shown in figure 12.
Figure 16 shows a stent component with fasteners modified with respect to the fasteners shown in figure 15. Each fastener in figure 16 includes a wire (for example, a U-shaped wire), with both ends of the wire attaching directly to the same rod so that the configuration of the fastener / rod forms a substantially oval / circular opening. The rod (s) in figure 16 can be substantially the same as the rods shown in figure 15.
Figures 17/18, 19 and 20 show additional examples of double stent valves in accordance with some embodiments of the present invention. The 1700 single stent valve of figure 17 includes stent 1702 and valve component 1704. Figure 18 shows the double stent valve that includes 1700 stent valve and 1802 positioning stent, which can be attached together by means of example) of an annular groove and corresponding annular recess. The stent component 1802 can be covered with, for example, pericardium in order to prevent paravalvular leakage. The double stent valve of figure 18 can be provided with a generally cylindrical shape that is suitable, for example, for pulmonary and / or aortic applications.
Now with reference to figures 19 and 20, figure 19 shows the double stent valve with first stent 1902, second stent 1904, and 29 valve component 1906. Figure 20 shows the double stent valve with first stent 2002, second stent 2004, and valve component 2006. Once again, the positioning stents in figures 19 and 20 can be covered (for example, with pericardium) in order to prevent paravascular leakage. The stents in figures 19 and 20 may be suitable, for example, for pulmonary valve replacement (for example, in the presence of an aneurysm that creates a deformation and where there is no suitable rim for the placement of the grooved stent valve). More particularly, with regard to pulmonary valve applications, many candidates for pulmonary valve replacement are endowed with an aneurysm thereon or with a funnel type configuration in the inward or outward flow. Thus, the first 1902 or 2002 stent can adapt to this funnel-type pulmonary artery configuration and provide the round orifice to secure the stent valve (1904, 1906) or (2004, 2006). In some embodiments, the double stent valve similar to the double stent valve of figure 20 can be provided suitable for mitral and / or tricuspid valve applications, where the positioning stent is provided with a reduced height and an oval configuration that provides a round rim for attachment to a groove of a stent valve (alternatively, a hook-loop attachment system can be used). Alternatively or in addition, the positioning stent can be provided with independently foldable elements that provide a secure fit in the implantation field. Additional structural characteristics of the modalities shown in figures 17 -20 and details regarding their use for valve replacement will be apparent from those skilled in the art from the drawings.
Fig. 21A shows another example of a stent valve 2100 according to some embodiments of the present invention. The modality shown in figure 21A may be suitable, for example, for replacing a mitral valve. Stent valve 2100 can be assembled from a stent component and a valve component outside the patient's body prior to sending the 2100 stent valve to an implantation field. The 2100 stent valve can be a self-expanding stent valve adapted to replace the mitral valve. As shown, the stent valve 2100 can be shaped similar to an opposite double crown. The 2100 stent valve may include a 2102 porcine pulmonary valve sutured in a Dacron conduit (prosthetic tube), with two self-expanding “Z” nitinol stents 2104 and 2106 sutured on the external surface of the prosthesis in such a way that create two self-expanding crowns. The self-expanding stent valve can be filled for shipping in a Teflon sheath, or other suitable shipping system. In this modality, Dacron is used to cover the stent, although in other modalities other materials such as Teflon, silicone, pericardium, etc., can be used. In a surgical approach, a 1-centimeter incision can be made in the left atrium, controlled by sachet-type sutures. The Teflon sheath with a filled stent can be pushed along a guide wire (the atrium having been punctured with a needle and the guide wire inserted) until the middle of the stent valve reaches the mitral ring. The sheath can then be pulled back to unfold the ventricular side first, followed by the complete removal of the sheath to expose the atrial side. Additional details regarding the 2100 stent valve and a surgical approach to send it to an implantation field are described in Liang Ma et al., Double-crowned valved stents for off-pump mitral valve replacement, European Journal of Cardio-Thoracic Surgery 28: 194 - 199, June 13, 2005, which is incorporated herein by reference in its entirety.
Figures 21B - E show views of a double-conical stent in accordance with some embodiments of the present invention. Referring to Figures 21B and 21C, the double-conical stent may include a substantially cylindrical stent 2108 that carries a 2110 valve as well as two substantially conical stents (2112, 2114) affixed / attached to the 2108 stent (for example, with VELCRO®, suture (s), friction fitting (s), other suitable fixation mechanisms, or a combination thereof). Figure 21D shows a cross section of the double-conical stent shown in figures 21B and 21C. In other embodiments, at least one of the stents 2112 and 2114 can be provided with a crown shape with protruding ears formed from closed or open cells or “Z” shaped stents. The first and second additional stents (2112, 2114) can collectively form a fixation element 2116 (figure 21C; for example, annular groove) similar to the fixation element 202 shown in figure 2A. The fixing element 2116 may allow fixation, for example, in a hole of a failed valve that is similar in size to the stent 2108 that carries the valve component 2110 or to an anchor stent with the complementary annular projection. In some embodiments, stents 2112 and 2114 (and optionally stent 2108) can be replaced with a single stent in the double-conical configuration (for example, the two cones connected by a continuous region in the area of the fixture 2116). An advantage of using separate stent (s) for the cones / fasteners is that the mechanical stresses of the cones / fasteners (for example, first and second stents 2112 and 2114) can be at least partially separated from of the 2108 stent containing the valve. In some embodiments, at least the additional stent or portion thereof positioned closest to the tip of the delivery system (for example, stent 2112) can be recapture by the delivery system. To facilitate said recapture, the additional stent can be formed in a 2118 pyramid or wing cross-section configuration (figure 21E). In some embodiments, the wing (s) or ears of stent 2112 (and / or 2114) can be formed at various positions / heights along a central axis of stent 2108 similar, for example, to the stent shown in figure 7B. By having different positions / heights for at least some of the wings or ears, coupling can be facilitated, for example, with native valves of different sizes. In some embodiments, the stents shown in figures 21B - 21E (for example, stent 2108) may include at least one fixing element to be removably attached to a shipping device, similar to the fixing elements 808 shown in figure 8B.
Figures 22A - 26C show examples of delivery systems for sending stent valves (e.g., single stent valves or double stent valves) to an implantation field in accordance with some embodiments of the present invention. In some embodiments, the present invention provides a minimally invasive surgical approach whereby surgery is performed on a beating heart without the need for an open chest cavity and cardiopulmonary bypass. The heart can be penetrated, for example, transapically through a relatively small opening in the patient's body. For example, to replace the failed aortic valve, the patient's body can be penetrated through an intercostal space (for example, fifth intercostal space), which is a region between two ribs. From this access point, the left ventricle can be penetrated at the apex of the heart. In one approach, the suitable stent valve delivery system can initially penetrate the body / heart (for example, 2600 delivery system (figures 26A - 26C) which includes an integrated introducer). In another approach, a separate introduction sheath can be used. A guide wire (hollow needle, catheter, rigid guide wire, etc.) can be inserted through the introducer to guide the delivery, for example, of stent components), a valve component, and / or other devices (for example, an occlusive device). In some modalities, approaches to transluminal, transatrial, or transventricular access may be used, for example, to replace the tricuspid and / or mitral valve. The right ventricle of the heart can also be accessed to replace the pulmonary valve. This is different from other surgical approaches that send replacement valves through an open chest cavity. In addition, as described in greater detail below with respect to figures 22A - 28C, delivery systems in accordance with some embodiments of the present invention release the proximal portion of a first stent valve, which can allow testing of the valve when the body is accessed, for example, transparietally. With successful testing, the distal portion of a stent valve can be released. This is in contrast to the stent delivery systems that initially release the distal portions of their associated stents.
Figures 22A - 22D show a shipping system 2200 that includes two concentrically arranged parts, a first set (including elements 2202 - 2210) and a second set (including elements
2216 - 2230). More particularly, the first assembly may include the tip 2202 at the distal end of the sending system (with a guide wire passing through the length of the sending system and out of the tip), the inner shaft 2204, outer sheath 2206, metal shaft 2208, and driving rod 2210. The second set can include outer (distal) shaft 2216, outer shaft tapered connector 2218, outer shaft (proximal) 2220, stent support 2222, bend protector 2224, support stem connector 2226, support stem cup 2228, and 2230 O-ring. As shown, the 2210 push rod is located at the proximal end of the shipping system. In figures 22A and 22B, the external axis 2220 has been split along its length to allow components of the shipping system 2200 to be shown in greater detail. Valve 2212 and stent (s) 2214 form a third set that can, for example, be filled and curled between the first and second sets.
With respect to the first set, the internal shaft 2204 functions as a light for a guide wire. Tip 2202 is attached at its distal end. As used herein, bonding refers to any suitable bonding / fixing mechanism such as, for example, adhesive bonding using cyanoacrylate or UV curing adhesives or bonding / heat welding using heating energy to melt the components to be assembled. The outer sheath 2206 can be connected to the proximal section of the tip 2202 and can restrict the stent valve (2212, 2214). The external sheath 2206 can be drilled to allow the device to be rinsed using the support rod 2210. The proximal part of the first set can be reinforced with the metal shaft 2208 and can end on a push rod with a Luer connector for rinsing the guide wire light.
With respect to the second set, the stent holder 2222 can be connected distally on the outer distal axis 2216. Figure 22D shows a better perspective view illustrating the composition between the stent valve (2212, 2214) and the stent holder 2222. The distal external axis 2216 can be connected proximally to the external proximal axis 2220 by means of the tapered connector 2218. The proximal external shaft 2220 can be connected by means of a fold protector 2224 to the support rod assembly, which may include a support rod connector 2226 and a support rod cup 2228. The support rod assembly can compress the 2230 “0” ring to seal the 2200 shipping system. A Luer connector can allow the device to be rinsed. The flushing mechanism can be used to remove trapped air from the delivery system prior to insertion into the body. Alternatively or in addition, the flushing mechanism can be used to cool the stent (for example, nitinol stent) prior to its release and / or recapture by rinsing the stent with a cold saline solution. The cooling of the stent can cause a reversible modification of its structure, thus reducing its Young modulus and, therefore, the radial force of the stent and the forces necessary for its sending and recapture.
The 2200 delivery system is said to be in an open position (figure 22C) when (for example) the push rod 2210 comes into contact with the support rod cup 2228. In the open position, the stent valve (2212, 2214 ) can stand out from the 2222 stent support and fully expand into an implantation field. Before the 2200 delivery system reaches the open position, the stent valve can be crimped onto the 2200 delivery system using a crimping machine (for example) and held in place by the 2222 stent holder. The 2222 stent holder can be attached to the stent fixation elements shown in figures 8A - 16. The crimped stent valve can be maintained in a collapsed configuration by pulling back the first set thus covering the 2222 stent bracket / bracket components with the outer sheath 2206. Once the outer sheath 2206 is removed so that the it no longer restricts fixing components, the stent valve can automatically detach from the 2222 stent bracket due to the self-expanding property of a stent valve. The delivery system 2200 is said to be in a closed position (figures 22A and 22B) when the outer sheath 2206 completely encompasses the stent valve (2212, 2214) so that there is no expansion of a stent valve.
The delivery system 2200 is said to be in the partially open position when (for example) the push rod 2210 is partially pushed towards the support rod cup 2228. In said partially open position, the stent valve (2212, 2214) it is positioned proximally and fixed distally to the 2222 stent support by means of the fixing elements. This allows for precise implantation / positioning of a stent valve. For example, the stent valve can be partially released proximal to the intended implantation field and relatively pushed distally until resistance is perceived. Final release of a stent valve (2212, 2214) can occur by fully pushing the push rod towards the support stem cup 2228 so that the delivery system 2200 reaches the open position. Said partially open position is shown in figure 28B. In some embodiments, an imaging mechanism can be used to determine whether the stent valve is correctly positioned in the implantation field. For example, mapping under fluoroscopy can be performed with angiography, intravascular ultrasound (IVUS), intracardiac echocardiography (ECI), transesophageal echocardiography (TEE) or other mechanism (s) or combinations thereof, whose imaging mechanism may be by least partially integral to or separated from the shipping system.
With the implantation of a stent valve (2212, 2214), the delivery system 2200 can revert to a closed position before withdrawal from the patient's body, for example, when retaining the first set and pushing the second set distally in tip direction 2202 / outer sheath 2206. In other embodiments, the stem for releasing the stent valve may comprise a screw mechanism for transferring a rotational movement of the stem into a translational movement of the outer sheath. This type of delivery system can allow the stent to be released and recaptured in more precise stages, as well as to reduce the release force perceived by the surgeon.
Figures 23A - 23D show another example of a delivery system 2300 according to an embodiment of the present invention. The shipping system 2300 can be substantially similar to the shipping system
2200 (figure 22) (for example, closed position, figures 23A and 23B; open position, figure 23C), except that the delivery system 2300 may additionally include one or more folded balloons 2302 (for example, proximal to the stent valve) . Unless otherwise indicated, similar characteristics in figures 23A - 23D correspond to the same reference numerals in figures 22A - 22D, although the reference numerals have not been reproduced in figures 23A - 23D to avoid complications in the drawings. The same applies to the stent delivery system shown in figures 24A - D, figures 25A - C, and figures 26A - C. The balloon 2302 can be inflated / deflated by means of an additional light on the proximal external axis 2304, for example, to anchor the stent valve (for example, a non-self-expanding stent valve) in place in an implantation field. Figure 23D shows a cross section AA of the light structure shown in figure 23C. The light structure includes 5 light tubes 2306 and inner axis 2308. In other embodiments, other structures for the 2306 light tube can be used (for example, double light tube where the second light is used to inflate and deflate the balloon). The delivery system 2300 may also include access mechanism 2310 for inflating / deflating the balloon, which may allow the connection of the syringe or inflation device for inflating / deflating a balloon. Alternatively or additionally, a tube with a register can be connected to the 2310 access mechanism.
Figures 24A - 24D show another example of a delivery system 2400 according to an embodiment of the present invention. In the sending system 2400, the proximal external axis 2402 can be provided with a larger diameter compared to the diameter of the proximal external axis 2220 (figure 22). The larger diameter can reduce bleeding when the delivery system is used without an introducer. Alternatively, when an introducer is used, the largest diameter may correspond to the inside diameter of the introducer which, in turn, may depend on the outside diameter of the outer sheath. Having no space between the introducer and the delivery system can reduce the risk of potential withdrawal from the delivery system through the introducer due to trapped blood. Thus, the shipping system 2400 may include a float tube 2404 that fills the space between the inner and outer assemblies, thereby reducing the risk of the inner assembly bending under compression which would result in increased frictional forces within the shipping system during stent recapture. The shipping system 2400 can be substantially similar to the shipping system 2200 in all other respects (for example, closed position, as in figures 24A and 24B; open position, Figure 24C).
Figures 25A - C show another example of a shipping system 2500 according to an embodiment of the present invention. The 2500 delivery system may include one or more 2536 balloons distal to the stent valve. With the balloon (s) distant to the stent valve, it is avoided having to introduce the delivery system more deeply into the body (for example, into the ascending aorta) in order to perform the dilation, thus reducing the risk of damage to the body and improving the manipulation of the device (for example, without flexing the rigid device over the aortic arch). The 2536 balloon (s) can be used, for example, for valvuloplasty before implantation of the stent valve and / or post-dilation of the implanted stent valve to improve stent anchorage. Figures 25B and 25C show the balloon (s) 2536 in the closed and open positions, respectively.
The first set of delivery system 2500 may include tip 2502, inner balloon shaft 2504, outer sheath 2506, and flotation tube 2508. The second set may include inner (distal) shaft 2510, stent support transition 2512, support bracket stent 2514, sleeve 2516, tapered transition axis connector 2518, and external (proximal) axis 2520. The stem assembly can include support rod connector 2522, support stem cup 2524, O-ring 2526, metal shaft 2528, and push rod 2530. The balloon assembly can include outer shaft 2532, inner shaft 2534, balloon 2536, and em ”2538 connector.
Figures 26A - C show another example of a shipping system 2600 according to an embodiment of the present invention. The shipping system 2600 may include an integrated introducer 2602, which may be an additional set that houses the second set. The outer sheath of the shipping system is shown as 2604. The introducer 2602 may include a connecting line 2606, a register 2608 and a housing 2610 for the sealing member 2612. Register 2608 can serve as an access point, for example, for a syringe containing fluid (for example, saline). The connection line 2606 can serve to transport the fluid from the syringe to the internal light of the introducer, and sealing membrane 2612 can seal the introducer from the external environment. With the implantation of the stent valve, components of the 2600 delivery system (for example, first set and second set) other than the 2602 introducer can be removed through the introducer. Then, another medical device such as, for example, a closure device can be introduced through the 2602 introducer. As another example, intravascular ultrasound equipment (IVUS) (for example, mini-probe) can be introduced through the 2602 introducer. The 2600 shipping system can be substantially similar to the 2200 shipping system in all other respects.
Figure 27 is a flow chart 2700 of the illustrative stages involved in replacing a failed valve (for example, native or artificial) according to some embodiments of the present invention. Figures 28A - 28C illustrate (without limitation) several stages referenced in the flow chart of figure 27. In stage 2702, a stent valve (for example, single stent valve or double stent valve) can be removably attached to a shipping system. For example, one or more fasteners of a stent component (for example, the fasteners 808, figure 8B) can be attached to a stent holder of the shipping device (for example, stent holder 2222, figure 22 ). A collapsing element (for example, external sheath 2206, figure 22) can be disposed on the stent fasteners / brackets to keep the stent valve in a collapsed configuration and attached to the delivery system.
In stage 2704, the stent valve can be sent to an implantation field in a collapsed configuration. For example, Figure 28A (introduction and positioning) shows stent valve 2802, en39 while still attached to the delivery system by means of stent support 2804 and completely contained within the outer sheath 2806, can be introduced into the patient's body at long guide wire 2808 so that the end 2810 of the sending system passes through the failed valve 2812. The delivery system can be manipulated forward and / or backward, for example, until the stent valve is believed to be correctly positioned.
In stage 2706, the stent valve can be partially expanded, for example, to determine (stage 2708) whether the stent valve is in fact correctly positioned and / or to test (stage 2710) whether the stent valve is functioning properly. For example, figure 28A (partial release) shows that the outer sheath 2806 can be partially removed from the proximal section 2814 of a stent valve, while the fastening elements 2816 of a stent valve are still restricted by the outer sheath 2806 on the 2804 stent bracket.
In stage 2712, when the stent valve is correctly positioned in the implantation field and / or the stent valve is functioning properly, the stent valve can be detached from the delivery system in order to make the stent valve expand to your fully expanded configuration. For example, figure 28C (final release) shows that, with the removal of the fixing elements 2816 and the stent support 2804 from inside the outer sheath 2806, the fixing elements 2816 of the stent valve 2802 can detach from the 2804 stent support automatically (or in response to balloon inflation in other embodiments) thereby causing the stent valve to expand to its fully expanded configuration. The second set of the sending device can then be joined with the first set / outer sheath and removed from the patient's body. For example, figure 28C (removed from the shipping device) shows that the second set 2818 can be passed through the replacement stent valve 2802 towards the distal end of a stent valve. Then, the second assembled set 2818 and the first set / outer sheath 2806 can be passed through stent valve 2802 once again in the proximal direction before exiting the patient's body.
When the stent valve is not positioned correctly (stage 2708), in stage 2714 the stent valve can be reverted to a collapsed configuration and repositioned within the patient's body. An illustration of this scenario is illustrated in figure 28B (stent recapture / repositioning), in which the outer sheath 2806 is slid proximally over the proximal section 2814 of a stent valve in order to recapture the stent valve. The stent valve is then repositioned and released so that the fixture 2820 of a stent valve receives a ring 2822 from the failed valve. Similarly, when the stent valve does not function properly in response to the test (stage 2710), in stage 2716 the stent valve can be reverted to the collapsed configuration and removed from the patient's body.
Thus it is seen that stent valves (for example, single stent valves and double stent valves) and associated methods and systems for surgery are provided. Although particular arrangements have been described in detail here, this has been implemented by way of examples for the purpose of illustration only, and is not intended to be limited with respect to the scope of the appended claims, which follow. In particular, it is contemplated by the applicant that several substitutions, changes, and modifications can be implemented without departing from the spirit and scope of the present invention as defined by the claims. Other aspects, advantages and modifications are considered to be within the scope of the following claims. The claims presented are representative of the present invention described herein. Other unclaimed inventions are also contemplated. The applicant reserves the right to seek the said inventions in subsequent claims.
28 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26 Sheet 27 Sheet 28
123 members in 18 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 60843181 | United States of America | – | |
| 84318106 | United States of America | P | |
| 84318106 | United States of America | P | |
| 11700922 | United States of America | – | |
| 70092206 | United States of America | A | |
| 70092206 | United States of America | A | |
| 11700922 | – | – | – |
| 60843181 | – | – | – |
| US20060700922 | – | – | – |
| US20060843181P | – | – | – |
Members123
| Document | Office | Kind | |
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| 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 | |
| BRPI0722366A2This record | 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 | |
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| 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 | |
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| EP2422750A3 | European Patent Office (EPO) | A3 | |
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| 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 |
4 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Patent application refused [chapter 9.2 patent gazette]B09B | B09B | |
| Patent application refused [chapter 9.2 patent gazette]B09B | B09B | |
| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]B07A | B07A | |
| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]B03A | B03A |
Numbers
- Publication
- PI0722366
- Publication, DOCDB
- PI0722366
- Publication, EPODOC
- BRPI0722366
- Application
- 22366
- Application, DOCDB
- PI0722366
- Application, EPODOC
- BR2007PI22366
Titles2
- Portuguese
- SISTEMA DE ENVIO DE STENT-VÁLVULA CARDÍACA
- English
- STENT-HEART VALVE SHIPPING SYSTEM
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