Endovascular aortic valve replacement

ES 2 142 829 T3

DESCRIPTION

Devices to carry out an intraluminal procedure.

This invention relates to devices for carrying out an intraluminal procedure, and in particular to devices for endovascular replacement of a heart valve.

It is often necessary to replace malfunctioning heart valves within the body. The replacement of the heart valves has generally been carried out by means of a serious open heart surgical procedure, which requires general anesthesia, full bypass (full bypass) of the cardiopulmonary flow with total cessation of cardiopulmonary activity, from seven to ten days of hospitalization, and months of recovery time. The mortality rate with this type of procedure is approximately five to six percent.

Endovascular procedures for valve replacement are an alternative to open heart surgery. For example, in patients with severe aoortic valve disease who are at too great a risk to tolerate open heart surgery, surgeons have used endosvacular balloon aortic valvoplasty. This procedure involves the use of a dilatation of an endovascular balloon to split the existing commissures in the diseased aoortic valves with commissural fusion and to cleft the existing calcification plaques in the calcified stenotic aoortic valves. This method provides only partial and temporary relief to a patient with a stenootic aoortic valve. Often it is necessary to repeat the procedure a year after the first procedure has been carried out.

An alternative therapeutic regimen is endovascular valve supplantation. In this procedure, instruments are used to insert a mechanical valve into the lumen of a central blood vessel by entering through a distal artery, which can be, for example, the brachial or femoral artery. In the sense in which they are used in relation to the vasculature in this application, the descriptive words distal and proximal refer to the direction away from and to the direction that approaches the site of replacement of the valve or of execution of the valve. procedure, as applicable. A guide wire is introduced through the entry vessel, and is directed fluoroscopically to the desired location. They are then guided over flexible catheter guide wires that are used to force and direct the new valve through the blood vessel to the desired central location near the dysfunctional heart valve, where it supplants the function of the existing valve.

In contrast to open heart surgical procedures, endovascular cardiac procedures will require only local anesthesia, partial cardiac bypass or no cardiac bypass and one to two days of hospitalization, and should have a reduced percentage of mortality compared to heart procedures. open. However, as has been described in the literature but has never actually been practiced, endovascular supplantation of heart valves was limited to artery-based supraannular mechanical valves, which require an elongated fixation catheter originating from at the distal arterial point of entry to maintain the position of the valve in the aorta, and therefore does not provide a permanent or internalized system. Valve supplantation is also limited to the treatment of regurgitant aoortic valves, and is not applicable to stenotic aortic valves or any other dysfunctional heart valves. Furthermore, once implanted, the mechanical valves predispose the patient to form thrombi and emboli, requiring the application of long-term anticoagulant therapy; intracranial hemorrhages being a serious side effect of long-term anticoagulant therapy.

A potential alternative to a mechanical valve is a bioprosthetic valve. A bioprosthetic valve can be a homograft (a newly obtained human valve from a donor), an allograft (a fixed human valve), or a xenograft (a fixed valve from another species). In contrast to xenograft valves, homograft valves are rarely used due to lack of access to human valves recently obtained from a donor. Porcine valvules preserved in glutaraldehyde are often used, since they are easily accessible and storable and are available in a variety of sizes. Replacement with a bioprosthetic valve does not predispose a patient to thrombi or emboli, and therefore does not require long-term anticoagulant therapy. Bioprosthetic valves are currently a fundamental pillar of aoortic valve replacement. Replacement with a bioprosthetic heart valve is preferable in patients who cannot tolerate long-term anticoagulant therapy or who are otherwise potentially unfit to undergo a long-term medicinal regimen.

To date, bioprosthetic and mechaonic valves have been inserted near or at the site of the native annulus by open-heart surgery, and, with the exception of the Magovern-Cromie valve, which used fixatives to fix the valves, have required sutures. for its fixation in the insertion site; no means are available for endovascular valve replacement with any valve. Therefore, it would be interesting to provide endovascular means I) to easily remove a natural or prosthetic valve that presents dysfunction, and II) to replace the valve that presents dysfunction with a flexible bioprosthetic or synthetic valve suitable for endovascular replacement, independently fixed without sutures or catheter, near or at the site of the annulus of the native valve.

US-A-3,671,979 issued to Moulopoulos on June 27, 1972 describes an endovascularly inserted conical umbrella-shaped valve positioned and held in place by an elongated catheter for fixation at a supra-site2

ES 2 142 829 T3 null with respect to the aortic valve in a nearby arterial vessel. The conical end faces the dysfunctional aortic valve, and the distal ends of the umbrella open against the wall of the aorta with reversed blood flow, thereby preventing regurgitation.

US-A-4,056,854 issued to Boretos on November 8, 1977 describes a supraannular valve fixed with catheter and endovascularly inserted that is delivered while being constricted in a capsule, opening the circular rim of the valve to be in contact with the wall. of the artery abutting therein, and attached flaps of flexible membrane extending distally into the vasculature once released from the delivery capsule. The flaps engage against the artery wall during forward flow, and close inward toward the central catheter to prevent regurgitation during reverse blood flow. The Boretos valve was designed to be positioned against the artery wall during forward flow, compared to the central medial position of the Moulopoulos valve, to reduce stagnation of blood flow and the consequent formation of thrombi and emboli that it is to be expected of a valve in a medial central position.

Studies on replacement valves include the following: Gibbon's Surgery of the Chest, 5th ed., David C. Sabiston, Jr., MD, Frank D. Spencer, MD, 1990, Vol. II, Ch. 52, pp. 1566-1596, and Textbook of Interventional Cardiology, Eric J. Topol, 1990, Chs. 43-44, pp. 831-867.

In contrast to US-A-4056854, a first aspect of the invention follows a delivery capsule for a replacement valve having a fastener to hold the capsule in position while the valve is forced out of it.

Preferably, said fastener is differentially and circumferentially expandable to hold said introducer capsule in position during release of said replacement valve device.

Preferably, said pusher is a disk.

US-A-4,787,899 describes a system for carrying out an intraluminal procedure, and in particular an intraluminal graft system.

US-A-3540431 presents a barrier for a body lumen that is provided endoluminally by being constricted inside a capsule. This barrier is attached to a guide wire by means of which it can be removed from the capsule, thereby expanding into contact with the lumen.

A barrier follows a second aspect of the invention, however, it has a differentially and circumferentially expandable fastener that allows modifications to be made to the angle of a working conduit of the barrier in relation to the situs.

Preferably, the barrier is of selectively permeable material, with a distal end configured so that it faces downstream of the receiver.

There may be a tissue cutter to remove the unwanted tissue, the tissue cutter having at least one blade and a cable, said at least one movable blade being put into a state in which it is not extended, and said blade being suitable. to be passed endovascularly to the situs while it is in that state.

Preferably, said at least one blade has a hinge to allow movement of the blade between the state in which it is extended and the state in which it is not extended, and vice versa.

Embodiments of the present invention are described below by way of example only and with reference to the accompanying drawings, in which:

Figure 1 illustrates a capsule of the device for executing the procedure in side view.

Figure 2 is a side view of a device for performing the intraluminal procedure.

Figure 3 is a bottom plan view of an intraluminal procedure execution device.

Figure 4 is a top plan view of an intraluminal procedure execution device.

Figure 5 illustrates a tissue cutter in a closed position.

Figure 6 illustrates a tissue cutter in an open position.

Figure 7 is a side view of a valve introducer capsule with the support balloons deflated.

Figure 8 is a side view of a valve introducer capsule with the inflated holding balloons.

Figure 9 is a side view of a valve introducer capsule with the balloons passed over a guide wire.

Figure 10 is a side view of a pusher disc advancing a valve out of the introducer capsule.

Figure 11 illustrates an aoctic valve in side view.

Figure 12 illustrates an aoctic valve in top plan view.

Figure 13 is a side view of an aoctic valve with the locking ring in the closed position.

Figure 14 is a front view of an aortic valve with the locking ring in the open position.

Figure 15 is a graphical illustration of a side view of the change that occurs when anchoring the fasteners with inflation of the balloon.

In a preferred aspect, the present invention relates to devices for the (supplantation) or replacement of a heart valve in a recipient by endovascular means. The valve replacement system includes up to five devices: (1) a device that constitutes the prosthetic valve, (2) a device for introducing the valve, (3) a device for performing the intraluminal procedure, (4) a capsule of the device for execution of the procedure, and (5) a tissue cutter. It is not necessary that all the devices of the system be used, since they are for the replacement of a valve; The description of valve replacement using all components is given merely by way of example.

ES 2 142 829 T3

In a general method, the capsule of the procedure execution device (Fig. 1), which contains the intraluminal procedure execution device, is introduced at an entry point in the receiver, and is used to transport the procedure execution device. intraluminal procedure to the desired situs, over a guide wire. In situs, a selectively permeable barrier from the intraluminal procedure device emerges from the procedural device capsule, opens in a controlled and adjustable manner, and comes into contact with and rests on the lumen of the vessel surrounding the former valve or prosthesis (Figs. 2, 3 and 4). The guide wire is withdrawn from the working conduit of the intraluminal procedure device leaving the conduit available for passage of the tissue cutter, an angioscope, ultrasound devices, tissue grabbers, and tissue cutting devices. The canal can also be used for irrigation or for the application of a suction device to remove debrided tissue, thrombi or other materials.

The tissue cutter is then introduced into the receiver through the working conduit of the device for performing the intraluminal procedure, being taken to the valve site, where it is used to cut and remove the existing valve from the site (Figs. 5, 6). The exact positioning of the cutter is ensured using transesophageal echocardiography and ultrasound and intraarterial or intracardiac angioscopy (a). The accuracy of valve removal and replacement is important to the success of endovascular valve replacement. Currently, several imaging techniques are available that provide complementary options to ensure this precision: 1) transesophageal echocardiography can be used continuously; 2) intravascular ultrasound passed through the working duct of the device for performing the intraluminal procedure; 3) intravascular ultrasound passed intravascularly through the venous system through the intraatrial septum through the mitral valve and into the left ventricle; and 4) an angioscope can be passed into the left ventricle in a similar manner, which provided the additional advantage of allowing constant high-definition imaging of the entire procedure and high-flow irrigation.

All the tissue debris resulting from the procedure is trapped by the barrier of the intraluminal procedure execution device, or they are removed from the receiver by means of suction and tissue removal devices that are introduced through the working conduit of the procedure execution device. intraluminal procedure. Tissue debris is removed through the working conduit of the intraluminal procedure device with suction devices and grips (eg extractor basket or grasping forceps), or is trapped in the barrier of the procedure execution device. intraluminal to avoid embolism. Once all the necessary tissue has been removed, contraction of the tissue cutter allows the tissue cutter to be withdrawn through the working conduit of the intraluminal procedure execution device. The barrier of the intraluminal procedure execution device is contracted, and the intraluminal procedure execution device is withdrawn into the capsule of the procedure execution device, which is then withdrawn.

The valve introducer device, which contains the device that constitutes the prosthetic valve, is then introduced and used to transport the replacement valve to the valve situs, over a guide wire (Fig. 7). The valve inserter holder, which may optionally include positioning balloons that surround the valve inserter capsule, is differentially inflated so that certain balloons inflate more or less than others to ensure the exact positioning of the prosthetic valve as it is released from the introducer capsule (Fig. 8). One means of pushing the valve out of the introducer capsule, once the introducer capsule is in the proper position, is to advance the pusher device of the valve introducer device into the capsule (Fig. 9). One means to fix the fixators in the desired location is to inflate a balloon inside the device that constitutes the prosthetic valve and inside the lumen of the fixation ring (Figs. 10-15). The capsule positioning balloons and the intraluminal balloon can then be deflated, and the valve introducer device is removed.

In order to aid the patient's circulation during endovascular aoortic valve replacement, it will be necessary to put the patient on partial or complete cardiopulmonary bypass. Various means are currently available to provide this assistance. For example, one method is the percutaoneal insertion of the venous and arterial cannula with decompression of the left ventricle through insertion of a pulmonary arterial conduit that allows the aspiration of blood and a significant decrease in left ventricular filling and ejection (a).

The invention provides several advantages, including the possibility of replacing or supplanting existing cardiac or other valves or prostheses using sutureless endovascular means and thus avoiding the open-heart surgical procedure, which is more risky, more expensive and more complicated. This device constituting the prosthetic valve, preferably using a bioprosthesis or other flexible prosthesis resistant to thrombus formation for the valve leaflets, avoided the need for permanent anticoagulant therapy for the recipient. Once inserted, the valve is able to function autonomously. Furthermore, in the past bioprosthetic replacement valves have required sutures, and consequently open heart surgery to proceed to fixation in the annulus or situs of the vasculature. The fixation device used with the valve allows it to be fixed using endovascular means,

ES 2 142 829 T3 without the need for sutures. The prosthetic valve is permanently inserted, and remains embedded in the device throughout the life of the valve. The duration of a bioprosthetic valve can be, for example, more than twenty years. Future developments may provide alternative prosthetic valves with a considerably longer life. Since patients who are unable to tolerate open heart procedures are mostly elderly, the bioprosthetic valve will usually outlive the patient. The intraluminal procedure delivery device and cutter provide the new possibility of performing endovascular procedures without the serious side effect of causing dislodged debris and other emboli to circulate within the vasculature.

The components of the valve replacement system are described below. The capsule of the device for executing the method comprises a cylindrical sleeve made of a durable flexible material, such as polyurethane coated with Tefloan or other materials having the following characteristics: The material must be flexible so that it can be easily maneuvered through the vasculature, it must be durable so that it can resist abrasive contact and pressure from instruments inserted and contained within it, and it must be non-thrombogenic so that blood clots do not develop and adhere to its surface. The capsule of the method executing device has a generally cylindrical outer surface and a generally cylindrical inner surface, with a mesh or grid-like design. This capsule is characterized by the fact that it is capable of containing the barrier of the device for executing the intraluminal procedure and other devices that could be used intraluminally, and of being able to be transported intraluminally. The device is introduced over a guide wire to the mentioned location (Fig. 1).

A means to partially remove the capsule (15) from the device for executing the procedure to allow the full opening of the device for executing the intraluminal procedure is to screw the distal end of the capsule of the device through a screw mechanism (10) procedure execution and the proximal end of the working conduit (5) of the intraluminal procedure execution device. After turning the working conduit in the thread of the capsule of the procedure execution device, the intraluminal procedure execution device can be made to advance into and out of the capsule of the procedure execution device. . Once the work is finished, the device for executing the intraluminal procedure can be withdrawn back into the capsule of the device for executing the procedure, and can then be fixed inside the capsule by rotating the working conduit in the thread of the capsule of the device for carrying out the procedure in the reverse order (Fig. 2).

The intraluminal procedure performance device serves to assist in the performance of intraluminal procedures through the use of endovascular or other intraluminal means, and comprises a setter (the "barrier") and a tube (the "working conduit"). The barrier (20) comprises an umbrella-like cone with a generally tapered outer surface and a generally tapered inner surface (Fig. 2). Materials for making the cone include flexible, durable, and selectively permeable material (such that only selected sizes of particles can pass through), such as polypropylene, polyester, dacron, or nylon mesh on plastic supports. stainless steel. The apex of the cone is perforated to free the outlet of the working conduit, and is oriented downstream in the vasculature. The barrier is suspended on the stainless steel cloth (Fig. 3). A dilatation device (25, the “Fastener”), such as a balloon (Fig. 4), is circumferentially attached to the barrier. The balloon can have from four to twenty segments, separated from each other by two diaphragms. Each segment of the balloon has a separate inflation / deflation conduit that allows each segment to have differential inflation directed from a central external control device. The external device for the inflation and / or deflation of each segment of the Bra consists of means such as syringes or compressed air cylinders in parallel. Each has a valve in series that allows inflation when pressure is applied and passive or active deflation when the valve is opened. Differential inflation of each segment of the balloon allows for subtle variations in the angle of the working duct in relation to the valve situs. Once the inflation has been carried out, the barrier is characterized by being able to allow blood flow through its permeable surface, preventing back pressure and embolization, and providing a region for the execution of the working procedure delimited by the inner surface of the barrier. and extending from the distal ends of the barrier proximally into the vasculature and the heart (Fig. 2).

The tube of the intraluminal procedure execution device, which is the working conduit, consists of an elongated flexible cylinder. The working conduit is made of a durable flexible material, such as polyurethane coated with Teflon or other materials that have the following characteristics: they are flexible, durable and non-thrombogenic materials. The tube has a generally cylindrical outer surface and a generally cylindrical inner surface. The proximal open end of the working conduit is secured around the perforated caonic apex of the barrier, and its distal end runs through and out of the vascular entry point. For its use in a human adult, the working duct preferably has an internal diameter of approximately 0.5 to 10 millimeters, whose diameter makes it suitable to allow the passage of instruments, such as ultrasound devices, angioscopy, des5

ES 2 142 829 T3 flange, aspiration, irrigation and extraction, and of the tissue cutter, from the outside of the receiver to the region in which the work procedure must be executed. For the use of said working conduit in a receiver that is not a human adult, this range of internal diameters can be varied up or down, depending on the size of the receiver and the lumen. It may also be helpful to apply suction or irrigation to the working duct.

The tissue cutter comprises at least one proximal blade and a cable. The proximal blade (45) comprises a folding articulated blade (30), of a length varying between approximately 1.0 and 20 millimeters, with sharp-edged cutting surfaces. This range of blade lengths can be varied up or down depending on the size of the receiver and lumen. Alternatively, the proximal blade may consist of a flexible wire that can be rotated at high speed, which will provide cutting contact with tissue. The blade was made of a sturdy, durable material, such as stainless steel or elgiloy (elgiloy = beryllium alloy). The proximal blade was characterized by being able to pass through the working conduit to the region of execution of the working procedure, being in a state in which it is not extended, and then being able to extend to allow the cutting of all unwanted tissue. and to finally return again to its state in which it is not extended. Additional blades can be attached to the proximal blade to increase the cutting capacity of the tissue cutter (Figs. 5, 6). For example, by applying fusion or joint joint welding or other joint methods, two distal blades (40) can be attached to the distal ends of the proximal blade, two shorter distal blades (40), approximately 0.5 to 5 , 0 millometers. This range of blade lengths can be varied up or down, depending on the size of the receiver and lumen. These blades provide sharp-edged cutting surfaces at an angle range of approximately thirty to one hundred and fifty degrees relative to the proximal blade, allowing simultaneous cutting at multiple angles.

The fabric cutter cable (35) consists of a durable and flexible elongated wire, and was characterized by being able to drive the fabric cutter (Fig. 6). The lead was attached to the proximal blade in a central or off-center position, and was connected distally to an external motor. For example, the cable can be a steel coaxial cable connected to a DC motor for variable speed rotation.

The valve introducer device comprises a tube that constitutes the introducer capsule, a pusher device and a holder. The introducer capsule consists of a cylindrical sheath having a generally cylindrical outer surface and a generally cylindrical inner surface and is reinforced at the proximal end, which is open, and has a semi-closed distal end with a perforated opening, the distal opening having a diameter that is approximately equal to the inner diameter of the introducer conduit (50) (Fig. 7). The introducer capsule is made of a flexible, durable, and non-thrombogenic material, such as Teflon-coated polyurethane, in a mesh or grid design. The introducer capsule was characterized by being able to contain and maintain the device that constitutes the protosic valve in its compressed state, allowing its easy transport through the recipient's vasculature. The introducer capsule is reinforced at its base with a solid element that is not a mesh or grid and that is, for example, solid polyurethane coated with Teflon, to support the fixing ring and the fixators of the device that constitutes the prosthetic valve in the state thereof in which said valve is compressed while being inside the introducer capsule.

Fastener (70) was circumferentially attached to the outer surface of the introducer capsule at the proximal end of the capsule. The bra consists of a differentially expandable device, such as a series of segmented balloons, and is characterized by having the ability to expand to hold the introducer capsule in a precise position during the release of the device that constitutes the protosic valve (Fig. 8) . Each segmented balloon may have an inflation / deflation conduit to produce autonomous dilation and compression of the segments. The differential dilatation of the segmented balloon series is governed from a central external control device in the same way as it is done with the devices for the execution of the intraluminal procedure. The inflation of each segment differentially allows to carry out an exact positioning of the introducer capsule in proximity to the desired site of placement of the valve.

The tube of the valve introducer device, which is the introducer conduit, consists of an elongated flexible cylinder. The introducer conduit (50) was made of a durable flexible material, such as polyurethane coated with Teflon or other materials that have the following characteristics: they are flexible, durable and non-thrombogenic. The introducer conduit has a generally cylindrical outer surface and a generally cylindrical inner surface. The proximal end of the introducer conduit was circumferentially fixed around the distal opening of the introducer capsule, and the distal end of the introducer conduit exits through the vascular entry point (Fig. 9). For use in a human adult, the introducer conduit preferably has an inner diameter of approximately 0.5-10 mm, the inner diameter of which makes said conduit capable of containing the pusher conduit (55) of the pusher device. For the use of this introducer conduit in a recipient other than a human adult, this range of internal diameters can be varied up or down, depending on the size of the receiver and the lumen. The introducer conduit and the pusher conduit are also characterized by being capable of

ES 2 admit suction or irrigation instruments into its lumen.

The pusher device comprises a disk and a tube. The pusher disk (60) of the pusher device consists of a generally circular disk, with a generally flat distal surface, a generally flat proximal surface, and a central opening. The diameter of the opening should be less than the diameter used in the introducer conduit. The pusher disc is made of a durable flexible material such as polyurethane coated with Tefloan or other materials that have the following characteristics: they are flexible and durable. The proximal surface of the pusher disc is in contact with the device that constitutes the prosthetic valve and that is contained within the introducer capsule (Fig. 9).

The proximal end of the tube constituting the pusher conduit is attached to the distal surface of the pusher disc circumferentially around the central opening of the pusher disc. The pusher conduit consists of an elongated flexible cylinder and is made of a flexible, durable and non-thrombogenic material that can maintain its structural integrity in such a way that it will not deform when an external pressure is applied (eg polyurethane coated with Teflon ). The pusher conduit has a generally cylindrical outer surface and a generally cylindrical inner surface, and has a smaller inner diameter than that used in the introducer conduit (Fig. 10). Said pusher conduit is characterized by being capable of being contained within the lumen of the introducer conduit, with its distal end extending beyond the vascular entry point through the introducer conduit, and of allowing the passage of the fixation balloon (75) and the guide wire (65). Said pusher conduit is also characterized by being able to advance inside the lumen of the introducer conduit, when an external pressure is applied to the vascular entry point to cause the pusher disc to advance inside the introducer capsule. The pusher conduit is also characterized by being able to accommodate aspiration or irrigation instruments inside its lumen.

The device that constitutes the prosthetic valve comprises a sleeve (80), a valve and an annulus. The sleeve is a flexible cylinder of cylindrical shape having a generally cylindrical outer surface and a generally cylindrical inner surface. The sleeve is fixed on its inner surface to the valve and at the base of its outer surface to a compressible annulus, which is the fixing ring (85) (Figs. 11, 12). The means of attachment may include chemical bonding, laser welding, stapling, or other means. Fixation materials can include polypropylene, polyesters, niloan, stainless steel, or other inert and durable materials. The sheath is made of a durable, flexible, compressible material, compatible with the receptor and non-thrombogenic, such as dacron or polytetrafluoroethylene, to allow it to be easily compressed, maneuvered and transported through the vasculature to allow

829 T3 12 endovascular placement. The durability of the sleeve allows it to be solidly attached to other objects and fitters, and allows the sleeve to remain intact despite the replacement procedure and the long residence time of the prosthetic device inside the receiver. All components of the device that make up the prosthetic valve, namely the clamping ring, the sheath, and the valve, are flexible, compressible, non-thrombogenic, and durable.

Attached to the inner positioner of the device that constitutes the prosthetic valve is a valve that functions by allowing unidirectional circulatory blood flow. The valve comprises a cylindrical shaped annulus (100) having a generally cylindrical outer surface and a generally cylindrical inner surface, and contains at least one quasp (95) to allow one-way blood flow. The quasp (s) is (are) attached to the distal end (relative to blood flow) of the cylindrical annulus. The quasp (s) is (are) opened distally to allow circulatory blood flow through the valve situs, and then is (are) closed alternately and centrally to prevent circulatory backflow. The valve is flexible, compressible, compatible with the receptor and non-thrombogenic. The valve can be, for example, a glutaraldehyde-fixed porcine aoctic valve having three quasps that open distally to allow unidirectional blood flow. The valve can also be fresh allografts or xenografts obtained from a donor, cryopreserved or fixed with glutaraldehyde. The optimal material will be synthetic, being manufactured based on non-biologic, non-thrombogenic and flexible materials, so that the valve can be transported through the vasculature, biocompatible and very durable, so that the valve can resist permanent fixation in place. valvular. It is highly desirable to use flexible material when the valve must be introduced using endovascular means.

The fixing ring (85) of the device that constitutes the prosthetic valve is preferably attached to the base of the outer surface of the sheath. The clamping ring is made from materials that are durable, have high tensile strength and excellent fatigue resistance characteristics and are resistant to corrosion (such as stainless steel, MP35N or elgiloy), and it is structured. in the form of a compressible architecture, in such a way that it can contract when an external pressure is applied to it and it can expand when the external pressure is not applied, still being able to maintain its basic formation. The fixing ring has a generally cylindrical outer surface and a generally cylindrical inner surface, and consists of a series of fasteners (90) to fix the device that constitutes the prosthetic valve in the planned valve situs (Figs. 13-15) . The fixation ring provides a sutureless endovascular fixation of the device, allowing it to function autonomously. The fasteners are attached by fusion welding, soldering, or other joining methods at angles of about 30 to about 150 degrees to the ring.

ES 2 142 829 T3 fixation. The combination of angles provides a firm fixation, in such a way that the device that constitutes the prosthetic valve can tolerate the degree of pressure variation and the directional pressure variations that affect the valve during the different phases of the cardiac cycle. As uniform pressure is exerted on the inner surface of the fixation ring, for example by inflating the fixation balloon, the fixation ring expands, and the fixators open, penetrating and attaching to the lumen wall.

Once the endovascular implantation of the device that constitutes the prosthetic valve has been completed in the recipient, the operation of the device that constitutes the prosthetic valve can be supervised by the same methods as those used to supervise vascular replacements carried out by heart surgery. open. Routine fossil exams, periodic echocardiography, or periodic angiography may be performed. However, in contrast to open heart surgery, the recipient requires a short recovery period and may go home one day after the endovascular procedure. The device that constitutes the prosthetic valve can be used in all patients in whom bioprosthetic valves are indicated, and specifically in elderly patients with heart valve disease, and in patients who cannot tolerate open heart procedures or long-term anticoagulation. duration. Furthermore, with the development of non-thrombogenic flexible synoetic valves of greater duration as alternatives to bioprostheses, the device that constitutes the prosthetic valve will be indicated in all patients in whom the relative advantages of duration, non-thrombogenic quality and ease of insertion of the devices that constitute the prosthetic valves outweigh the disadvantages of the mechanical valves. Anticoagulation can be beneficial in certain clonic situations for a short or long duration application.

The device for performing the intraluminal procedure, the capsule of the device for performing the procedure, and the tissue cutter can be applied independently, or they can be applied in conjunction with each other, to serve as instrumentation in procedures performed in or for the removal of cardiac, aoortic, cerebrovascular, mesenteric, renal or peripheral vascular valves or tissues, and they will be especially important at any point in the cardiac or vascular system where peripheral embolization is problematic or an exact positioning of the instruments is essential. These devices can also be used in other body luomenes, such as the gastrointestinal, genitourinary, biliary and respiratory tracts. In addition, the valve replacement system can be used to supplant as well as to replace a valve or prosthesis of the recipient. In this procedure, the valve or prosthesis that presents dysfunction is not removed by the tissue cutter, and the device that constitutes the prosthetic valve is fixed in a vascular site that is such that the device supplants the function of the valve or prosthesis that presents they dysfunctioned. In addition, the devices could be used in non-human species, such as other mammals.