Stent-valves for valve replacement and associated systems for surgery

IS 2 586 121 T3

DESCRIPTION

Replacement valve

Background of the Invention

Conventional approaches to heart valve replacement require cutting a relatively large opening in the patient's sternum ("sternotomy") or chest cavity ("thoracotomy") in order to allow the surgeon to access the patient's heart. Additionally, these approaches require arrest of the patient's heart and a cardiopulmonary bypass (ie, the 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 during a first procedure. However, tissue adhesions that result from the first surgery can increase the risks, (eg 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; 1542-52; and Weerasinghe et al., "First Redo Heart Valve Replacement - A 10-Year Analysis", Circulation 1999; 99: 655-658; WO 01/49213 A2 describes prosthetic heart valves comprising a graft member covering at least a portion of an abluminal surface of a body of an endoluminal cannula. WO 2004/032987 A1 describes a medical device comprising a biocompatible polymeric product with a layered structure.

Synthetic valves and biological valves have been used for heart valve replacement 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. Such anticoagulant treatment significantly limits the activities of the patient and can lead to various other complications. Biological valves do not require such anticoagulation treatment, but typically fail by 10-15 years. Thus, to limit the need and risks associated with a new operation due to failure of biological valves, traditionally only patients with less than approximately 10-15 years of life have received replacements with biological valves. Patients with a longer life expectancy have received synthetic valves and anticoagulant treatment.

Attempts have been made to develop less invasive surgical methods for heart valve replacement. These surgical methods, referred to as percutaneous heart valve replacement therapy (PHVT), use a catheter to deliver a replacement valve to an implant site that uses the patient's vascular system. These PHVT attempts have several drawbacks, including their inability to ensure proper placement and stability of the replacement valve within the patient's body.

In view of the foregoing, it would be desirable to provide improved methods, systems, and devices for heart valve replacement.

Summary of the Invention

The present invention is defined in the claims.

Some embodiments described herein are directed to heart valve replacement systems, methods, and devices. For example, these methods, systems, and devices may be applicable to a full range of heart valve therapies including replacement of failed aortic, mitral, tricuspid, and pulmonary valves. Some embodiments may facilitate a surgical approach whereby surgery is performed on a beating heart without the need for an open chest chamber and a heart-lung bypass. This minimally invasive surgical approach can reduce the risks associated with replacing the failed native valve in the first instance, as well as the risks associated with secondary or subsequent surgeries to replace the failed artificial valves (eg, biological or synthetic). Endoluminal cannula valves according to the present invention include a valve component and at least one endoluminal cannula component (eg a single endoluminal cannula valve or a double endoluminal cannula valve). The valve component may include a biological or synthetic (eg mechanical) valve and / or any other suitable material (s). The endoluminal cannula and valve components are capable of at least two configurations: a collapsed configuration (eg during delivery) and an expanded configuration (eg after implantation).

In some embodiments, the endoluminal cannula component of the endoluminal cannula valve may include a first strut and a second strut with the ends located at different positions along a longitudinal axis of the endoluminal cannula component, wherein the first strut and the second brace provide axial resistance to anchor the endoluminal cannula at the implant site. Multiple first brace and second brace installations can be supplied, where such installations are located horizontally along the

ES 2 586 121 T3 along a perimeter of the endoluminal cannula component. In some embodiments, the first brace and the second brace can be connected.

Alternatively or additionally, the endoluminal cannula component of an endoluminal cannula valve may include multiple securing elements that protrude outwardly from an outer surface of the endoluminal cannula component, where each securing element includes a first end adjacent to the outer surface of the endoluminal cannula component. endoluminal cannula component and a second end spaced from the outer surface of the endoluminal cannula component. The second end of at least one first securing element may be located at a different position along a longitudinal axis of the endoluminal cannula component than the second end of at least one second securing element. For example, in one embodiment, the first securing element and the second securing element can have substantially the same lengths, and the first ends of the first and second securing elements can be located at multiple, different levels along the axis. longitudinal component of the endoluminal cannula. In another embodiment, the first securing member and the second securing member may have different lengths, and the first ends of the first and second securing members may be located at substantially the same level along the longitudinal axis of the cannula component. endoluminal.

In some embodiments, the endoluminal cannula component of an endoluminal cannula valve may include at least a first commissure post and a second commissure post adjacent to a body of an endoluminal cannula component, where the outer contours of the first and second Commissure posts collectively form a generally concave shape. In some embodiments, each of the outer contours may be inwardly sloped toward the center of the corresponding commissure post in the direction of the body of the endoluminal stent component. In other embodiments, the outer contours of the adjacent commissure posts may be generally convex in shape.

The valve component of an endoluminal cannula valve includes a fabric covered outer surface (at least a portion thereof, or substantially the entire surface). The valve component may include at least one suture along a free edge of the valve component and at least one suture along a free flow-inlet edge of the valve component, wherein the fabric includes a skirt that fits extends below the valve component. A free edge of the skirt can be folded over a lower portion of the corresponding endoluminal cannula component and sutured to the endoluminal cannula component. Substantially all or at least a portion of the fibers in the fabric are oriented +/- 45 degrees with respect to the longitudinal axis of the valve component. Additionally, the endoluminal cannula component may include at least one Y-shaped structure attached to the valve component by one or more (eg 3) sutures that form a corresponding Y-shaped configuration. In some embodiments, the endoluminal stent component comprises an annular groove and the free edge of the skirt is located within the groove. Alternatively or additionally, the free edge of the skirt comprises at least one cut oriented in the direction of a longitudinal axis of the endoluminal cannula component. In some embodiments, the annular groove can be at least partially filled with a fibrous material, foam, or other biocompatible material.

In still other examples described herein, an endoluminal cannula valve delivery system is provided. A first assembly is supplied including an outer sheath and a guide wire tubing. The delivery system also includes a second assembly that includes an endoluminal cannula holder configured for removable attachment to at least one attachment member of an endoluminal cannula valve. The endoluminal cannula valve can be located on the guidewire tubing of the first assembly. The first mount and the second mount can be configured for relative movement with respect to each other in order to transition from a closed position to an open position. In the closed position, the outer sheath may comprise the endoluminal cannula valve still attached to the endoluminal cannula holder and thus a constricted expansion of the endoluminal cannula valve. In the open position, the outer sheath may not constrain expansion of the endoluminal cannula valve and thus the endoluminal cannula valve can be separated from the endoluminal cannula holder and expanded to a fully expanded configuration.

In some examples, the first mount and the second mount can be configured for a transition from the closed position to a partially open position, to the open position. In the partially open position, the endoluminal cannula valve can partially expand but not separate from the endoluminal cannula holder because the outer sheath may still comprise at least one connecting element of the endoluminal cannula valve and the endoluminal cannula holder. When the endoluminal cannula valve is in the partially expanded configuration, it can be determined whether the endoluminal cannula valve will be positioned correctly if the endoluminal cannula valve is expanded to the fully expanded configuration. Alternatively or additionally, the functionality of the endoluminal cannula valve can be tested (eg to determine if the endoluminal cannula valve will allow sufficient blood flow) when the endoluminal cannula valve is in a partially expanded configuration.

In some examples, the first assembly of the endoluminal cannula valve delivery system may include a coil-reinforced outer sheath and / or a substantially dome-shaped tip, which may deliver

ES 2 586 121 T3 resistance to kinking due to the bending moment acting on the delivery system during placement within, for example, an aortic arch.

In some examples, the endoluminal cannula holder of the delivery system may include proximal and distal components located adjacent to each other (ie, no gap). This can reduce or eliminate the risk of seizing or damaging the outer sheath of the first assembly when the delivery device is closed.

In some examples, the endoluminal cannula holder may include at least one chamfered edge located adjacent to at least one attachment pin of the endoluminal cannula holder, where the at least one attachment pin is configured to removably attach to a connecting element of a component of the endoluminal cannula. The chamfered edge can assist with the release and expansion of the endoluminal cannula valve from the endoluminal cannula holder when the endoluminal cannula holder is axially rotated.

In still other examples described herein, an apparatus is provided for locating and attaching an endoluminal cannula valve comprising a plurality of attachment elements to a corresponding plurality of attachment pins of an endoluminal cannula holder. The apparatus may include an elongated, collapsible member (eg, suture or wire) configured to be threaded through a plurality of attachment elements. The apparatus may also include a tube to receive the elongated collapsible member. Pulling the elongated, collapsible member through the tubing while holding the tubing in a fixed position can collapse the diameter of the endoluminal cannula valve to allow engagement of the attachment members to the attachment pins.

In some examples, an apparatus is provided to collapse a diameter of an endoluminal cannula valve to allow captures of the endoluminal cannula valve within a sheath of a delivery system. The apparatus may include an elongated, substantially flat strip comprising an opening located perpendicular to the longitudinal axis of the strip. The elongated, substantially flat strip may include an end having a height less than the height of the opening, such that insertion of the end into the opening forms a loop. Upon placement of an expanded endoluminal cannula valve within the loop, pulling the end through the opening causes a reduction in the diameter of the loop and thus collapses the valve diameter of the endoluminal cannula. The elongated, substantially flat strip can be formed of a suitable material including, for example, polymer and metal.

Brief description of the 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 like reference characters refer to like parts throughout, and in which:

Fig. 1 shows an endoluminal cannula component including single braces in the proximal section of the endoluminal cannula;

Fig. 2 shows an endoluminal cannula component including double braces in a proximal section of the endoluminal cannula;

Figs. 3 and 4 show endoluminal cannula components that include multiple securing elements located at multiple levels, different in such a way that at least one securing element is located closer than the other securing element;

Figs. 5 and 6 show endoluminal cannula components having, respectively, convex and concave endoluminal cannula configurations.

Fig. 7 shows an endoluminal cannula component including a reinforced proximal section and reinforced attachment elements;

Fig. 8 shows an endoluminal cannula component including attachment elements located between the commissure posts;

Fig. 9 shows a fabric reinforcement for a valve component that covers all or substantially all of the external surface of the valve and forms a skirt in accordance with the present invention.

Fig. 10 shows details regarding suturing the valve component and fabric of Fig. 9 to an endoluminal cannula in accordance with some embodiments of the present invention.

IS 2 586 121 T3

Fig. 11 shows an endoluminal cannula valve including a multi-component fabric backing (eg 3) in accordance with some embodiments of the present invention;

Fig. 12 shows two configurations of the distal section of the endoluminal cannula valve delivery system;

Figs. 13 and 14 show two configurations of an endoluminal cannula holder of an endoluminal cannula valve delivery system;

Fig. 15 shows an endoluminal cannula holder with at least one chamfered edge;

Fig. 16 shows an endoluminal cannula valve delivery system in which the distal section of the delivery system has a reduced length;

Fig. 17 shows an endoluminal cannula valve delivery system with a gearbox type release handle;

Fig. 18 shows an endoluminal cannula valve delivery system with a trigger type release handle;

Fig. 19 shows a shaft of an endoluminal cannula valve delivery system having a bending stiffness that varies from its proximal to distal ends;

Fig. 20 shows a positioning device to assist a physician in implanting an endoluminal cannula valve in an appropriate location;

Figs. 21A-C show a system and corresponding method for locating and attaching an endoluminal cannula valve to an endoluminal cannula holder of a delivery system; Y

Figs. 22A-C show a system and the corresponding method for crimping an endoluminal cannula valve in a delivery system.

Detailed description of the invention

FIG. 1 shows an endoluminal cannula component in accordance with some embodiments that include the single struts 102 in a proximal section of the endoluminal cannula. Fig. 2 shows an endoluminal cannula component according to some embodiments that includes two struts (202, 204) in a proximal section of the endoluminal cannula. Such double braces can increase the radial resistance to crushing of the endoluminal cannula (eg axial resistance) and the out-of-plane bending stiffness of the proximal section of the endoluminal cannula, thus improving the anchoring of the endoluminal cannula within, for example , a failed biological valve, or a calcified native ring. In Fig. 1, multiple (10-15 or more) installations of the single brace 102 can be provided, for example, side by side around the circumference of the endoluminal cannula. In Fig. 2, the first brace 202 and the second brace 204 are provided, where the second brace 204 can be reinforced within the first brace 202.

Figs. 3 and 4 show some embodiments of endoluminal cannula components that include multiple securing elements located at multiple, different levels, such that at least one securing element is more closely located than another securing element. The securing elements can engage, for example, a failed biological valve or a calcified native ring. Fig. 3, the portions of the securing elements 302 located adjacent to the outer surface of the endoluminal cannula component are located at multiple, different levels (304 a, b, c) and each securing element 302 has the same or similar length 306. These securing elements may have similar out-of-plane bending stiffness. In Fig. 4, the portions of the securing elements 402 located adjacent to the outer surface of the endoluminal cannula component are located at the same level 404 and the securing elements 402 have multiple different lengths (406 a, b, c). In the configuration of Fig. 4, the shorter securing members 402 may have greater out-of-plane stiffness. High out-of-plane bending stiffness can prevent a full circular expansion of the endoluminal cannula valve that could result in a valve leak.

Figs. 5 and 6 show components of the endoluminal cannula according to some embodiments having different stem configurations (eg commissure post) according to some embodiments of the present invention. As shown in Fig. 5, each of the outer contours (eg, wires) of adjacent stems 502 and 504 may have a generally convex shape 506. Fig. 6 shows another embodiment in which the outer contours of adjacent stems (602, 604) collectively form a

ES 2 586 121 T3 shape 606 generally concave. In some embodiments, the concave shape may also have inward sloping characteristics. For example, as shown in Fig. 6, each of the slopes of the outer arches inward toward the center of the corresponding stem in the direction of the body 608 of the endoluminal cannula. The inclusion of a concavely shaped stem can, for example, avoid contact of the valve leaflets with the extended endoluminal cannula during systole and improve blood flow to the coronary arteries. Other embodiments of endoluminal cannula components include, for example, endoluminal cannula that include both convex and concave shaped endoluminal cannula (eg, endoluminal cannula component that includes at least one stem 502 and at least one stem 602).

Fig. 7 shows an endoluminal cannula component in accordance with some embodiments that includes reinforcing a proximal section of the endoluminal cannula with the connection of double braces 702 (for example the connection of braces 202 and 204 of Fig. two). This increases the radial force / resistance to crushing of the endoluminal cannula and the stiffness to out-of-plane bending of the elements that form the proximal section, thus improving the anchoring of the endoluminal cannula valve within the calcified annulus. Additionally, the attachment elements are reinforced 704 to reduce the risk of kinking under compression during release of the valve from the endoluminal cannula. The 706 geometry has also been changed (eg optimized) to locally reduce stresses and stresses.

FIG. 8 shows an endoluminal cannula component in accordance with some embodiments in which the attachment elements 802 are located between the commissure posts. This can reduce the overall length of the endoluminal cannula and accordingly the length of the delivery system, thus preventing its distal section from entering deep into the ascending aortic / aortic arch during valve release from the endoluminal cannula.

Figs. 9 and 10 show additional details regarding the valves of the endoluminal cannula according to some embodiments of the present invention. In Fig. 9, a fabric backing is provided that covers all or substantially all of the outer surface of the valve down the skirt 902. This can prevent outward pulling of the sutures and wear of the valve due to contact with the valve. the endoluminal cannula. A running suture 904 may be delivered along the cut aortic sinus, which may allow firm fixation of the valve to the commissure posts of the endoluminal cannula. Along with suture 906 running along the perimeter of the internal flow range, suture 904 can also increase seal integrity. The fabric covering the skirt can be integral and continuous with the fabric that runs between sutures 904 and 906, although in other embodiments the fabric of the skirt and the fabric between sutures 904 and 906 can be two separate pieces of fabric that are joined by sutures. The fibers of the fabric are oriented +/- 45 degrees with respect to the longitudinal axis of the valve of the endoluminal cannula. This may allow the diameter of the skirt to self-adapt to the diameter of the endoluminal cannula in its proximal grooved / flared section by slightly reorienting the direction of the fiber (smaller angle within groove, larger angle within flared section).

Fig. 10 shows details regarding the suture of the valve and fabric of fig. 9 to an endoluminal cannula in accordance with some embodiments of the present invention. As shown, the proximal section of the skirt 1002 can be folded over the section of the proximal flared / slotted endoluminal cannula. Y-shaped sutures 1004 can be supplied that hold the valve firmly within the endoluminal cannula and increase the integrity of the seal. In some embodiments, each Y-shaped connection can be made on the outside of one or more separate sutures, where multiple sutures can be supplied to prevent leakage in the event of a single stitch break. The free-floating edge 1006 of the skirt can be located within the groove of the endoluminal cannula and can serve as an additional barrier to blood by promoting clotting. In some embodiments, longitudinal cuts 1008 can be made along the free-floating edge between the sutures to build the flexible fins around the circumference of the endoluminal cannula within the slot. This can improve the barrier effect and increase the conformability of the skirt. Alternatively or additionally, the seal of the prosthesis can be improved by at least partially filling the groove with fibrous, foam-like material, or other suitable biocompatible material. The skirt may also have a smooth internal surface to minimize blood shear in the annular flow inflow tract of the prosthesis. A more structured surface can be provided on the external surface of the prosthesis in order, for example, to improve the sealing of the valve of the endoluminal cannula at the implant site.

Fig. 11 shows an endoluminal cannula valve according to some embodiments that includes a multi-component fabric backing (eg 3). Each component can have a trapezoidal geometry to accommodate the variation of the internal diameter of the endoluminal cannula about its longitudinal axis. When the components are sutured together, they can form a cylindrical or partially cylindrical skirt, which is flared at one end to avoid constricting the endoluminal cannula and thus reduce its anchoring force within the ring.

Fig. 12 shows two configurations for a distal section of an endoluminal cannula valve delivery system. The distal configuration 1202 includes a generally dilatory shape, a larger tip with an unreinforced outer endoluminal cannula sheath. In contrast, the distal configuration 1204 includes a general projectile or dome shape, a shorter tip with a coil reinforced outer endoluminal cannula sheath. Several

ES 2 586 121 T3 manufacturing technologies are available to make such coil-reinforced sheaths that include, for example, extruding an inner and an outer tubing, winding a stainless steel wire, and assembling the three components by fusion joining onto a chuck. Relative to distal configuration 1202, distal configuration 1204 may have improved resistance to kinking due to the bending moment acting on the delivery system during placement within, for example, the aortic arch. More specifically, the outer sheath of the coil reinforced endoluminal cannula can increase the resistance to mechanical kinking of the endoluminal cannula delivery system. Using the projectile tip with a reduced length can decrease the bending moment of the delivery system.

Figs. 13 and 14 show two configurations of an endoluminal cannula holder of the endoluminal cannula valve delivery system. In Fig. 13, the endoluminal cannula holder includes proximal and distal components separated by a space 1302. In some embodiments, the component that actually holds the endoluminal cannula is the middle metal component. The distal component can be conically shaped to facilitate sheath closure and prevent pinning. The proximal component can serve as a guide for the attachment of the endoluminal cannula elements and can prevent kinking under compression during valve release from the endoluminal cannula. In some embodiments, the distal, metallic, and proximal components can be separated into pieces, while in other embodiments they can be a single piece of solid construction. In Fig. 14, the proximal and distal components are located adjacent to each other, thereby removing space, which can reduce or eliminate the risk of seizing or damaging the outer sheath 1304 of the endoluminal cannula when the tube is closed. supply.

Fig. 15 shows another configuration of an endoluminal cannula holder. As shown, one or both edges (1502, 1504) located adjacent element 1506 (eg, pin) configured to remove the endoluminal cannula component attachment may be chamfered. In some embodiments, the endoluminal cannula holder may include multiple (eg 3) of such elements 1506 and the adjacent chamfered edge (s). The inclusion of the chamfered edge (s) on the surface of the endoluminal cannula holder may help to release the endoluminal cannula valve from the endoluminal cannula holder (s) 1506 when a rotational force is applied, for example, to a handle. supply system bracket.

Fig. 16 shows an endoluminal cannula valve delivery system in which a distal section of the delivery system has a reduced length (eg the length entering the ascending aorta) relative to a delivery system with a tip. distal chamfered. A hollow tip 1602 can be provided that encapsulates the attachment elements / endoluminal cannula holder assembly, which can provide the reduced length. Locating the fasteners between the commissure posts can allow for a further reduction in the length of the delivery system.

FIG. 17 shows an endoluminal cannula valve delivery system with a gearbox release according to some embodiments, including open and closed positions. To move from one position to the other, a handle position is required before translation, thus reducing handling errors.

Fig. 18 shows an endoluminal cannula valve delivery system with a trigger type release handle in accordance with some embodiments. In such embodiments, the translational movement to open the delivery system and release the endoluminal cannula valve can be delivered by depressing the trigger, thereby releasing the braking system and pushing forward the metal shaft connected to the outer sheath of the endoluminal cannula. . This system advantageously allows one handle to release the valve from the endoluminal cannula, while the other handle takes care of the implant location. The design of this release handle can be similar to, for example, commercially available products for dispensing, for example, silicone.

Fig. 19 shows a mid-section of an endoluminal cannula valve delivery system according to some embodiments, which may include a shaft having a bending stiffness that varies from its proximal to distal ends. A rigid proximal shaft can provide thrust from the delivery system, while the flexible distal section can allow for improved traceability when cornering. The axis may include apertures (eg, water jet cutting apertures) along its longitudinal axis (Figs. 17 and 19), where the apertures can be oriented towards two axes perpendicular to the cross section of the axis.

Fig. 20 shows a locating device to assist the physician in implanting the valve of the endoluminal cannula in an appropriate location in accordance with some embodiments. The locating device comprises three fingers or self-expanding antennae (eg, nitinol) constrained within an outer sheath, which may be coaxially slidable toward the endoluminal cannula valve delivery system. By retracting the outer sheath, the antennas initiate expansion and can be positioned under the internal flow tract of, for example, the aortic valve under fluoroscopic assistance. By exerting a slight force towards the annulus, the three fingers can act as a landmark to implant the valve of the endoluminal cannula.

Figs. 21A-C show a system and the corresponding method for locating and attaching an endoluminal cannula valve to an endoluminal cannula holder. As shown in Fig. 21A, a suture or other element 2102

ES 2 586 121 T3 continuous foldable (for example wire) can be threaded through the endoluminal cannula component attachment elements and then through a 2104 cannula or tubing. By pulling the suture and holding the tubing, the diameter The valve stem of the endoluminal cannula may collapse and the attachment elements can engage the element (s) (eg pins 2106) of the endoluminal cannula holder. In some embodiment, both ends of the suture are free, (such that both ends are fed through the tube and then pulled). In other embodiments, one end of the suture is free while the other end is fixed (for example to the tubing), such that only one end of the suture is threaded through the tubing and pulled. Subsequently, the outer sheath 2108 can be pulled proximally over the attachment elements, as shown in Figs. 21B and 21C. The suture can then be removed by pulling it back through the tie elements.

Figs. 22A-C show a system and the corresponding method for crimping an endoluminal cannula valve onto a delivery system according to some embodiments. Fig. 22A shows a thin, flat strip 2202 (eg polymer or metallic) with an opening 2204 perpendicular to its longitudinal axis and having a wide edge 2206 at one end and a narrow edge 2208 at the opposite end. When the narrow edge is inserted into the opening (ie the opening having a height greater than the height of the narrow edge), the strip forms a loop. As shown in Fig. 22B and 22C when the valve of the endoluminal cannula is placed inside the loop, pulling the edges of the two ends of the strip causes a reduction of the diameter 2210 of the loop thus crimping the valve of the cannula endoluminal. The valve of the crimped endoluminal cannula can then be constricted step by step by the outer sheath 2212. Generally, the locating and crimping systems shown in Figs. 21A-C and 22A-C provide ease of use by physicians or other technicians. In some embodiments, these locating and crimping systems can be low cost and disposable, and can be supplied as sterile accessories along with the delivery system and / or endoluminal cannula valve.

Thus it is seen that endoluminal cannula valves (eg single endoluminal cannula valves, dual endoluminal cannula valves) and associated surgical methods and systems are supplied. Although particular embodiments have been described herein in detail, this has been done by way of example for the purpose of example and illustration only, and is not intended to be limiting with respect to the scope of the final claims, which follow. For this purpose, any references to measurements, distances and the like are for illustrative / example purposes.