SYSTEM AND METHOD OF LIBERATION OF CARDIAC VALVE FIELD OF THE INVENTION The present invention relates in a general way, with methods and systems for cardiovascular surgery.
BACKGROUND OF THE INVENTION Various surgical techniques can be used to repair a diseased or damaged heart valve, such as annuloplasty (contraction of the valve annulus), quadrangular resection (narrowing of the valve leaflets), commissurotomy (cutting of the corners of the the valve to separate the lamellae from the valve) or decalcification of the tissue from the valve and the ring. Alternatively, the diseased heart valve can be replaced by a prosthetic valve. Where replacement of a heart valve is indicated, the dysfunctional valve is removed and typically replaced with a mechanical or tissue valve. Numerous different strategies have been used to repair or replace a defective heart valve. Surgery to repair or replace an open heart valve is a long and tedious procedure and involves a large thoracotomy, usually in the form of a sternotomy.median. In this procedure, a saw or other cutting instrument is used to cut the sternum longitudinally and the two opposite halves of the anterior or ventral portion of the rib cage are separated. In this way a large opening is created in the thoracic cavity through which the surgeon can visualize and operate directly on the heart and other thoracic contents. The patient should typically be placed on cardiopulmonary bypass for the duration of the surgery. Open chest valve replacement surgery has the benefit of allowing direct replacement of the replacement valve at its intended site. This method, however, is highly invasive and often results in significant trauma, risk of complications, as well as prolonged hospitalization and a painful recovery period for the patient. Minimally invasive valve replacement procedures have emerged as an alternative to open chest surgery. The Encyclopedia ikipedia defines a minimally invasive medical procedure as one that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the least, possible damage to those structures. Two types of minimally invasive valve procedures that have emerged are percutaneous valve procedures andtransapical valve procedures. Percutaneous valve procedures allow small incisions in the skin to allow direct access to the peripheral vessels or channels of the body to insert catheters. The transapical valve procedures pertain to the production of a small incision at or near the apex of the heart to allow access to the valve. The distinction between percutaneous valve procedures and minimally invasive procedures is also highlighted in a recent position statement from the Society of Thoracic Surgeons (STS), the American Thoracic Surgery Association (AATS), and the Society for Angiography and Interventions Cardiovascular (SCAI; Vassiliades Jr. TA, Block PC, Cohn LH, Adams DH, Borer JS, Feldman T, Holmes DR, Laskey WK, Lytle B, Mack MF, Williams DO.) The clinical development of percutaneous heart valve technology: a position statement from the Society of Thoracic Surgeons (STS), the American Thoracic Surgery Association (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI) J Thorac Cardiovasc Surg. 2005; 129: 970-6) . Because minimally invasive methods require smaller incisions, they generally allow for faster patient recovery with less pain and body trauma: This, in turn, reduces medical costs and the total disruption of the patient's life.
The use of minimally invasive methods, however, introduces new complexities to surgery. An inherent difficulty in the minimally invasive percutaneous method is the limited space that is available within the vasculature. Unlike open-heart surgery, percutaneous heart surgery offers a surgical field just as large as the diameter of the blood vessel used for access. As a result, the introduction of prosthetic tools and devices translates into a more complicated problem compared to open-chest surgeries. The device must be sized and configured to allow it to be inserted into the vasculature, maneuvered through it, and placed in the desired location. This may involve passing through significant convolutions, along a distance from the initial point of introduction, before placement in the intended site can be made. Andersen et al. discloses a valve prosthesis implanted in a body channel by means of catheterization in U.S. Patent Nos. 5,411,442; 5,840,081; 6,168,614; and 6,582,462; and U.S. Patent Application Serial No. 10 / 268,253, incorporated herein by reference in its entirety. Catheters are hollow flexible tubes which can pass into the blood vessels to the heart for diagnostic purposes.treatment. The release of valves expanded by the catheter through the body channels as described by Andersen et al., Thus depends on instruments of sufficiently small diameter as well as adequate length and flexibility to navigate the blood vessels. Transplastic, minimally invasive valve replacement procedures have emerged as an alternative to both open chest surgery and percutaneous valve surgeries. Bergheim et al., Presents improved methods and systems for the release of a heart valve in U.S. Patent Applications Serial Nos. 60 / 702,892 and 10 / 831,770, incorporated herein by reference in its entirety. Methods and systems for the repair, removal and / or replacement of heart valves through the apex of the heart are described. This is an improvement over minimally invasive percutaneous methods that attempt insertion into the vasculature as the transapical method that are not limited by the space that is available within the vasculature. Transapical release is also closer to the heart than catheter-based procedures. In vivo studies have shown that instrumentation for releasing catheter-based valves may not be well adapted for the procedurestransapical. When balloon catheters are inserted, as described in U.S. Patent No. 6,582,462 and U.S. Patent Application No. 10 / 831,770, it is difficult to direct the balloon and the valve toward the position resulting from the inherent lack of stiffness and flexibility of the catheters. This is especially true in minimally invasive transapical valve procedures. By their nature, catheters are designed to be long, flexible and flexible to navigate long distances through the vasculature. Catheters are also often susceptible to twisting. As a result, catheters are typically thin and made of flexible materials such as plastics or polymers. The catheters are also designed to be placed on guide wires to better direct the catheter to the correct place. Even so, it is difficult to easily and accurately release tools and devices over long distance. This is especially true in high flow situations such as a beating heart and in places that offer catheters a substantial amount of space to move within. The correct and exact placement of a heart valve requires a longitudinal positioning as well as an exact rotational positioning. It is important to correctly position the valve as much as possible in a position that mimics that of the native valve to maximize durability and function.
It is also important to avoid placing the valve in such a way that it blocks the left and right coronary affluent (as in the case of the aortic valve). Consequently, there is a need to maneuver and direct the valve accurately during implantation. There is also a need for a device that is more suitable for releasing valves during transapical procedures. During balloon inflation of a flexible foil valve, such as the hardened tissue valve, it is desirable for the valve to remain on the balloon until it is firmly placed at the implant site. In the case of valves expandable by a balloon, there is therefore a need for devices designed to ensure that the valve remains on the balloon during inflation. Bergheim further presents methods and assemblies for distal embolic protection in U.S. Patent Application Serial No. 10 / 938,410, incorporated herein by reference in its entirety. There, Bergheim describes distal embolic protection mounts for use during transapical valve surgery. To accommodate a distal embolic protection assembly along other valve insertion and replacement devices, it is important that the distal embolic protection assembly collapse to a substantially small diameter to minimize the space it occupies.
Macoviak et al., Presents a filter catheter used to capture potential emboli within the aorta during cardiac surgery and cardiopulmonary bypass in US Patent Serial No. 10 / 108,245, incorporated herein by reference in its entirety. The filters described by Macoviak are adapted for use during cardiopulmonary bypass, and not during cardiac surgery. The filters described by Macoviak also intend to be inserted through the femoral artery and also do not incorporate a temporary valve, useful for capturing large amounts of remains while performing latent cardiac surgeries. There is therefore a need for a more adequate filtration system for percutaneous and transapical valve surgeries. Consequently, although open heart surgery produces beneficial results for many patients, many others who may benefit from that surgery are unable or unwilling to experience the trauma and risk of current techniques. Therefore, what is needed are methods and devices that perform repairs and replacements of heart valves as well as other procedures within the heart and large vessels of the heart that provide greater accessibility to the heart valves than current minimally invasive techniques, requiring at the same time reducing trauma, risks, recovery timepain that accompany the most invasive techniquesSUMMARY OF THE INVENTION The present invention provides methods and systems for performing cardiovascular surgery, where access to the heart or large vessels is provided through the heart muscle. In preferred embodiments, access is provided through the apical area of the heart. The apical area of the heart is usually the rounded lower extremity of the heart, formed by the left and right ventricles. In normal healthy humans, this is usually behind the fifth left intercostal space of the medial median line. The unique anatomic structure of the apical area allows the introduction of various surgical devices and tools towards the heart without significant disturbance of the natural mechanical and electrical heart function. Because the methods and systems of the present invention allow direct access to the heart and large vessels through the apex, they are not limited by the size constraints that are presented by minimally invasive percutaneous valve surgeries. The access to the heart through the peripheral vessels (for example, femoral, jugular, etc.) in the percutaneous methods is limited to the diameter of the vessel, (approximately 1 to 8 mm), access to the heart through theThe apical area is significantly larger (approximately 1 to 25 mm or more). In this way, apical access to the heart allows greater flexibility with respect to the types of devices and surgical methods that can be performed on the heart and the great vessels. Accordingly, an object of this invention is to provide methods and devices for the repair, removal and / or replacement of valves or their valve function by access through the cardiac muscle, particularly through the apical area of the heart. It should be noted that although transapical procedures are referred to herein, those procedures are intended to encompass access to the heart through any wall thereof, and access through the apex is not limited. Although the apical area is particularly suitable for the purposes of the present invention, for certain applications, it may be necessary to have access to the heart in different places, all of which are within the scope of the present invention. In one embodiment of the present invention, a method is provided for releasing a prosthesis to a target site or near a heart. The method comprises introducing a delivery system in the heart, preferably at or near the apex of the heart, where a prosthesis is deposited in the release member attached to a delivery system,advancing the prosthesis towards the target site, and decoupling the prosthesis from the release member at the target site of the implant. In another embodiment of the present invention, there is provided a method for releasing a prosthesis to a pre-existing artificial valve in or near the heart. The present invention also provides an implant system for releasing a prosthesis to a target site at or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system and a prosthesis. In one embodiment of the present invention, the access system is a trocar, cannula or other device suitable for penetrating the heart, preferably at or near the apex of the heart; and the delivery system is substantially rigid and movably positioned within the trocar, where the prosthetic valve is placed within the release member attached to the delivery system. In one embodiment of the present invention, the release system is known as the Scapus ™ system. The term "Scapus R" denotes a support structure in the form of a thin or elongated rod that is substantially rigid. The term "substantially rigid" implies structural stability to withstand fluid pressures and other force without intentional deformation. On the other hand, the Scapus ™ can cover unionsor other means of controlled detection to allow directional control by the operator at predetermined points throughout the entire Scapus ™. In one embodiment of the present invention, the delivery system comprises a Scapus R and a release member. The delivery system can be used to release a variety of prosthetic heart valves, including reduced or non-reduced tissue valves. In one embodiment of the present invention, the release member comprises a mechanical or inflatable expansion member to facilitate implantation of the prosthetic valve in the target site. In another embodiment of the present invention, the release member is a balloon. In another embodiment of the present invention, the release member is a device used to expand bent valves. In yet another embodiment of the present invention, the release member may comprise an inflatable balloon-shaped member, whose distal and proximal ends have cross-sectional areas substantially larger than the portion of the balloon covered by the prosthesis, to prevent migration of the prosthesis. In a further embodiment of the present invention, the delivery system may comprise a perfusion tube or conduit to allow the flow of blood through the delivery member during the procedure. A further objective of the present invention isprovide systems and methods to convert a catheter into a Scapus ™ release system. In one embodiment of the present invention, a rigid, substantially thin guide bar is inserted into the catheter to give it similar characteristics to those of a Scapus ™. In another embodiment of the invention, a rigid, substantially thin guide sleeve slides on the outside of the catheter to give it characteristics similar to those of a Scapus ™. The delivery systems described herein can be used to release prosthetic valves to the four valves of the heart including the aortic valve, mitral valve, tricuspid valve and pulmonary valve. The different anatomical characteristics of the different cardiac valves (bicuspid versus tricuspid valves) can claim different cardiac valve designs. Therefore, in one embodiment of the present invention, the prostheses are designed to match the anatomy of the white valve position. In another embodiment of the present invention, the prosthesis is composed of a tissue valve mounted on a stent. A group of patients who benefited from a transapical procedure are patients who have had previous valve replacement, and where the replacement valves are failing. Instead of making anotherOpen chest procedure, many of these patients may be candidates for transapical valve replacements. This is especially the case for old patients who can not tolerate the effort of a new open chest procedure. For those patients, who have a failed valve, the new prosthesis released transapically inside the failed valve can be placed. Therefore, in one embodiment of the present invention, the new prosthesis equals the configuration of the failed valve. Some patients who have had previous valve replacements, and whose valve replacements are failing may also be candidates for percutaneous valve procedures. For those patients, who have a failed valve, a new prosthesis can be placed percutaneously released into the valve that is failing. The present invention also provides devices and methods for providing distal embolic protection and a temporary valve. In one embodiment of the present invention, the distal embolic protection system provides a filtering member for trapping embolic material that concurrently operates with a temporary valve. The filter and temporary valve assembly prevents backflow of embolic material and debris, while allowing fluid flow to the filter during surgery. The valve-filter combination can beunderstood and expanded to allow entry into small blood vessels or other body cavities. In one embodiment of the present invention, the filtration assembly is implanted in the heart or large vessels of the heart, downstream of the surgical site. In one embodiment of the present invention, the valvuloplasty balloon is inflated to increase the effective area of the heart valve orifice. In another embodiment of the present invention, the valvuloplasty balloon slides over the guidewire or drive sleeve connected to the distal embolic protection device. Since a transapical procedure does not provide a direct observation line, the formation of sufficient images of the heart, valves and other structures is important to provide diagnosis, guidance and feedback during the procedure. A Scapus ™ release system can be larger in diameter than a catheter and is thus more suitable for containing imaging transducers. Thus, in one embodiment of the present invention, an image transducer is placed on the release system. In another embodiment of the present invention, an external image forming transducer can be provided to view the operation field. Imaging systems can beused at any time or through the duration of the surgery. Imaging systems are well known to those skilled in the art and include transesophageal echo, transthoracic echo, intravascular ultrasound imaging (IVUS), intracardiac echo (ICE), or injectable dye that is radiopaque. It can also be used cinefluoroscopy. In another embodiment of the present invention, a positioning balloon is used to assist in positioning the Scapus ™ correctly, so that the new prosthesis (or other alternative tools) land in the proper place. In yet another embodiment of the present invention, the method and system may further comprise means for removing at least a portion of the patient's heart valve by a cutting tool and being removed over the delivery system. In a further embodiment of the present invention, the methods and devices of the present invention can be adapted to provide a valve decalcification system, where the delivery system is capable of providing a solution of dissolution to the treatment site by access to through the apical area of the heart. The delivery system may be a catheter or a Scapus ™ that is configured with means for introducing andremove the solution solution to the treatment site. The delivery system can also provide the treatment site to prevent the dissolution solution from entering the patient's circulatory system. Those means for isolating the treatment site may include a barrier, such as a double balloon system over the catheter that inflates from both sides of the treatment site. The present invention provides methods and systems for creating a calcified animal model for use in the development and testing of heart valves. Although many of the above embodiments are referred with respect to the aortic valve in the heart, the present invention can also be used for procedures related to the mitral valve, tricuspid valve and pulmonary valve. The above aspects and other objects, features and advantages of the present invention will become apparent to those skilled in the art from the following description of the preferred embodiments taken in conjunction with the accompanying figures.
BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a partial front view of a patient's chest showing a prosthesis introduced into the apex of the heart through the fifth intercostal spaceusing an implant system. Figure 2 describes a trocar that penetrates the apex of the heart and into the left ventricle. Figure 3 shows two independent balloon release members contained on the Scapus ™ release system to provide both valvuloplasty and valve release. Figure 4 shows a prosthetic valve placed on a balloon in the form of "dog bone". Figure 5 shows a Scapus ™ release system and a distal embolic protection assembly. Figure 6 shows a Scapus ™ release system and a distal embolic protection assembly. Figure 7 shows the distal embolic protection system placed in the aorta and inserted through the femoral artery. Figure 8 shows a prosthetic valve implanted in the heart. Figure 9 shows a Scapus ™ release system. Figure 10 shows a Scapus release system. Figure 11 shows an approach of a balloon release member of a Scapus R delivery system. Figure 12 shows a distal embolic protection subsystem. Figure 13 shows a protection systemtemporal valve distal embolic. Figure 14 shows a double balloon system to provide a valve decalcification system. Figure 15 shows an exploded view of a cardiac valve implanted within a previously implanted heart valve. Figure 16 shows a heart valve implanted within a previously implanted heart valve.
DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Figures 1 to 16 show modalities of the methods and systems of the present invention for the repair, removal and / or release of prosthetic valves, and also to provide distal embolic protection and a temporary valve during cardiovascular procedures.
METHOD OF RELEASING THE VALVE AND IMPLANT SYSTEM Figure 1 is a partial front view of the chest 11 of a patient 10 and shows the position of a surgical tool 29 in relation to other anatomical landmarks, such as sternum 13, xiphoid 14, ribs 15 and heart 12. A surgical tool 29 is described entering. the body cavity through the fifth intercostal space 16 and through the apex of the heart 12. The surgical tool29 is observed inserted through an access system 31. The surgical tool 29 may contain devices or systems used for surgical procedures in or on the heart or large vessels of the heart. In one embodiment of the present invention, the surgical tool 29 is a delivery system. In another embodiment of the present invention, the surgical tool 29 may be a distal embolic protection device. The surgical tool 29 can enter the body cavity through several other places 17A, 17B and 17C in the chest 11. In another embodiment of the present invention, the surgical tool 29 can be a plurality of devices. In one embodiment of the present invention, the surgical tool 29 is both a delivery system and a distal embolic protection system. In one embodiment of the present invention, the implant system comprises an access system, delivery system and a prosthesis. In one embodiment of the present invention, the prosthesis is a cardiac valve prosthesis. In another embodiment of the present invention, the access system 31 is a trocar, cannula or other device suitable for penetrating the apex 18 of the heart 12. In another embodiment of the present invention, the delivery system is composed of a release member , where the prosthetic valve is placed on the release member. In otherembodiment of the present invention, the delivery system is substantially rigid. In another embodiment of the present invention, the substantially rigid support structure of the delivery system is called Scapus ™. Inherent in this definition, the term Scapus ™ implies a rigid support structure with other devices, tools and assemblies attached to it. In one embodiment of the present invention, the release member of the delivery system is linked to the Scapus ™. The delivery system described in the present invention presents major advances on the use of catheters as delivery systems for procedures in the near vicinity of the heart. By their nature, catheters are designed to be flexible to navigate great distances. Catheters should also be able to twist and bend to move through folds in the vasculature, such as those found in percutaneous procedures. The catheters are also designed to be placed on guide wires to better direct the catheter to the correct place. Even with the use of guide wires, it is difficult to easily and accurately release tools and devices over long distances. This is especially true in high flow situations, such as a procedure with a beating heart. Correct and accurate placement of a heart valve requires longitudinal positioningas well as an exact rotational positioning. It is important to correctly position the valve as much as possible in a position that mimics the native valve to maximize durability and function. It is also important to avoid placing the valve in such a way that it blocks the left and right coronary affluent (such as in the case of the aortic valve). The precise release of heart valves in transapical procedures requires exact and precise longitudinal and rotational positioning. Longitudinal positioning involves positioning throughout the aorta. Rotational positioning involves rotational positioning around the entire direction of the aorta. The path from the apex of the heart to the four heart valves is also a substantially straight line, which means that maneuvering characteristics such as bending, twisting and bending the catheter are not typically desired. Indeed, the inherent maneuvering characteristics of a catheter are disadvantageous in this procedure since they allow bending and twisting and are not able to hold the release member in place during valve implantation. The flow and blood pressure inherent in a procedure with a beating heart in combination with a catheter delivery system therefore does not allow for the releaseaccurate and precise prosthetic valves. An object of the present invention is therefore to provide a release system that is substantially rigid to withstand any unintentional bending or twisting. A Scapus ^, in contrast to a catheter, provides enough rigidity to accurately and accurately deliver a prosthesis during a procedure with a beating heart. A Scapus ™ release system is designed to bend or bend unless it is attempted by the operator. The Scapus ™ of the present invention may incorporate joints or other bending means at predetermined points to allow the operator to adjust the direction or angle of the release path in a controlled manner. In one embodiment of the present invention, the Scapus ™ provides rigid support between the operator and the distal portion of the delivery system located in the heart. In contrast to the catheter delivery system, a Scapus ™ release system can incorporate a larger cross-sectional area since access through the heart walls provides a larger access hole diameter (in some cases up to 25 mm or more) compared to the vasculature (0 to 8 mm or less). In one embodiment of the present invention, the Scapus ™ is made of a material that substantially resiststhe bend and twist. An example of that material is stainless steel or substantially strong polymeric plastics. In one embodiment of the present invention, the Scapus ™ is a solid rod. In yet another embodiment of the present invention, the Scapus ™ is a hollow rod. The Scapus ™ can contain one or more lights to move fluid. A Scapus ™ can also contain drive members such as rods, wires, guide wires or catheters. The ScapusMR can also conduct or transmit electricity or electrical signals and can also transmit light or light signals. A Scapus ™ can also transmit radiation or other forms of energy such as ultrasound, ultraviolet light, infrared light or gamma rays. A catheter used for percutaneous valve procedures is typically longer than 50 cm to navigate through the vasculature. In contrast, the length of the Scapus ™ can be less than 50 cm. In preferred embodiments of the present invention, the length of the Scapus ™ can be approximately 15-30 cm in total, of which approximately 10 cm can be inserted into the heart, and the remaining length left out. The methods and systems of the present invention can be used to implant a variety of heart valve prostheses known in the art, including stent and stent-free valves. The methods and systemsof the present invention can also be used to implant a variety of stent. In one embodiment of the present invention, the prosthetic release member is located toward the distal end of the delivery system. Valves with stent can be expandable with mechanical or balloon expansion devices, or can be self-expanding. Self-expanding stent can be constructed of elastic material such as metal alloys or shape memory. An example of a metal alloy with shape memory is Nitinol. The valves are expanded using a valve expansion member located on the release system. In one embodiment of the present invention, the release member is a mechanically driven device for expanding valves with stent. In another embodiment of the present invention, the release member is a balloon expansion device. In another embodiment of the present invention, the release member is a balloon used for radial expansion. In another embodiment of the present invention, the delivery member contains a self-expanding cardiac valve. There are numerous methods and systems for releasing a self-expanding cardiac valve. One example is U.S. Patent No. 6,682,558, incorporated herein by reference in its entirety. The valves with stent can also be expandable by unfolding the valve. The valve can beunfolded using a balloon or mechanical expansion device. Alternatively, the bent valves can be self-expanding. Self-expanding stent can be constructed of elastic materials such as memory-shaped alloys. The valves are expanded using the valve expansion member located on the release system. In one embodiment of the present invention, the release member is a mechanically driven device used to expand stented valves that have been bent. In another embodiment of the present invention, the release member is a balloon expansion device. In this modality, the balloon and the valve with stent have been folded together. When inflated, the balloon and the stented valve return to their original shape. When a stented valve is unfolded using a mechanical expansion device or a balloon, the stent that constitutes the stented valve is typically made of an alloy without shape memory. Examples of suitable materials include stainless steel, polymers, plastics and metals without shape memory. In another embodiment of the present invention, the release member is used to unfold stented valves made of memory-shaped alloys. In one embodiment of the present invention, the delivery member consists of a hollow tube in which the valve with stent is placed in a plate or mechanism ofdrive next to the valve used to push the valve out of the hollow tube. Alternatively, the methods and devices of the present invention may also be used to implant a prosthetic heart valve without a stent. In one embodiment of the present invention, the release member is adapted to place the tissue valve in the target site and the release member further comprises means for suturing or stapling the tissue valve to the valve annulus. Examples of suitable prosthetic valves are described in the following commonly owned patents: U.S. Patent Nos. 6,682,559; 5,480,424; 5,713,950; 5,824,063; 6,092,529; 6,270,526; 6,673,109; 6,719,787; 6,719,788; and 6,719,789, incorporated herein by reference. Examples of other valve assemblies suitable for use in connection with the present invention are described in U.S. Patent Nos. 5,411,552; 6,458,153; 6,461,382; and 6,582,462, incorporated herein by reference. Yet another valve suitable for use in connection with the present invention is described in US Patent Application Serial No. 10 / 680,071, incorporated herein by reference in its entirety. Access systems suitable for use in connection with the present invention typically comprise ahollow light and a first and second ends. In one embodiment of the present invention, the access system 31 is a trocar. The first end comprises means for penetrating the heart tissue and the second end comprises a hole through which the valve delivery system can be introduced into a hollow lumen of the trocar and towards the heart. Figure 2 describes an access system 31 that penetrates through the apex 18 of the heart 12. The direction of movement of the access system 31 is indicated by the arrow 19. The access system 31 can enter either the right ventricle 20 or to the left ventricle 21. To access the aortic or mitral valve, trocar 31 will preferably pass through the left ventricle 21. This produces direct access to the aortic or mitral valve. To access the pulmonary or tricuspid valve, the trocar 31 will preferably pass through the right ventricle 20. In another embodiment of the present invention, the access system 31 further comprises a valve positioned within its lumen. The valve is designed to reduce the significant backflow of blood out of the heart 12 after the access system 31 is inserted into the beating heart 12, while allowing the introduction of the delivery system and other surgical devices through the system. Access 31. Other access systems 31 and suitable devices are well known inthe technique and are described in U.S. Patent Nos. 5,972,030; 6,269,819; 6,461,366; 6,478,806; and 6,613,063, incorporated herein by reference. In one embodiment of the present invention, the operator places a suture by tightening with thread on the apex 18 of the heart 12 to create a seal around the access system 31. Another embodiment of the present invention allows the use of a Scapus ™ release system without an access system 31. It was contemplated that the physician becomes familiar with the advantages of the present invention and thus may find the use of a trocar unnecessary. In the latter case, the distal embolic protection system and the delivery system is placed directly through an insert at the apex 18 or other area of the cardiac wall. In another embodiment of the present invention, a release sleeve or delivery tube is placed over the delivery system. In one embodiment of the present invention, an out-of-shelf valvuloplasty balloon catheter is introduced through an access system 31 of the apex 18 of the heart 12, placing the balloon of the catheter inside the valve and the valve annulus. Valvuloplasty balloons are well known to those skilled in the art. Once the balloon is placed inside the valve, it can be inflated to expand a heart valverigid or narrow (stenotic or reduced heart valve) improving the flow of blood through the heart and to the rest of the body. Previous methods for performing valvuloplasty required the insertion of a catheter typically through the femoral artery or femoral vein, which is then guided through the heart and placed through the diseased heart valve. The methods and devices of this present invention, however, provide a more direct route to the valve to be treated. In another embodiment of the present invention, the release member of the delivery system described in the present invention is used for valvuloplasty of the diseased valve. In that embodiment, the release member of the delivery system is guided first to the diseased heart valve, and placed inside the valve and valve ring. After expanding the valve orifice, the release system is removed from the access system 31 and placed in a new prosthetic valve on the valve delivery system. The valve release system is further introduced through the access system 31 and the release member moves towards the position within the valve orifice to expand and implant the valve. In yet another embodiment of the present invention, two independent release members are contained in the delivery system. Each system is shown in the Figure3. Here, the delivery system 67 includes a Scapus 46, an infusion tube 49, and two independently operated balloon release members 90 and 91. That configuration allows the delivery system 67 to be used for both valvuloplasty and for release from valvule. In that embodiment, the distal most distal member 91 is guided first to the diseased heart valve, and positioned within the valve and valve ring. After expanding the valve orifice, the release system 67 is moved so that the second closest release ring 90, on which the prosthetic valve is placed, moves inside the valve and the valve ring to expand and implant the valve. In a further embodiment of the present invention, the perfusion tube 49 is not present and the balloons 90 and 91 are in intimate contact with the Scapus ™ 46. The use of two balloons 90 and 91 as shown in Figure 3 is not only practical in transapical valve procedures, but also in percutaneous valve procedures. Thus, in one embodiment of the present invention, Scapus ™ 46 shown in Figure 3 is a catheter. In a further mode of the above modality, the catheter is a multi-lumen catheter.
Balloon Systems and Implant Methods of Themselves Regardless of the type of release member ofvalve used, it is important that the prosthetic valve remains securely attached to the delivery member during implantation. This is especially true if the operator accidentally or intentionally lowers the pressure on the balloon (via a syringe, etc.). Thus, the present invention provides more balloons that are formed so that the distal and proximal ends of the balloon, not covered by the prosthetic valve, are larger in area, and thus prevent migration of the valve. That balloon can take the form of a "dog bone". Figure 4 shows a balloon release member 50 whose proximal end 70 and distal end 71 has a larger cross-sectional area than the middle portion of the balloon in intimate contact with the prosthetic valve 100. Figure 4 also shows a tube of perfusion 49 which extends across the balloon from the proximal end 70 towards the distal member 71 of the balloon delivery member 50 which allows fluid to flow through the length of the balloon release member 50. In one embodiment of the present invention, the balloon release member 50 does not contain an infusion tube 49. The orientation of the prosthetic valve 100 on the balloon release member 50 shown in Figure 4 relative to the proximal end 70 and the proximal end 71 of the balloon release member 50 depends on the method of implant withrelationship to the direction of blood flow through the native valve. The orientation shown in Figure 4 is preferred for the apical implant. In another embodiment of the present invention, the prosthetic valve 100 is orienin the opposite direction on the balloon release member 50. In one embodiment of the present invention, the distal end 71 and the proximal end 70 of the balloon delivery member 50 has a coating material having a greater coefficient of friction with the prosthetic valve in the position to the middle portion of the balloon release member 50. In the case of a balloon release member 50, an example of material that has a larger coefficient of friction with a prosthetic valve compared to the balloon is the fabric. The increase of the roughness in the plastic structure of the balloon will also increase the coefficient of friction with the prosthetic valve. The balloon-releasing member in the form of "dog bone" 50 described herein is not limito Scapus ™ release systems. These balloons can be used in any type of stent delivery. Thus, in one embodiment of the present invention, the balloon-releasing member in the form of "dog bone" 50 described herein can be used in any type of stent.or prosthetic valve release system. In one embodiment of the present invention, the balloon-releasing member in the form of "dog bone" 50 is used on a catheter valve delivery system such as those used for percutaneous valve delivery.
Release System and Methods Figure 5 describes a delivery system 67 consisting of a Scapus R 46, balloon inflation tube 45, connector of the proximal balloon release member 48, connector of the balloon member. distal balloon 51, perfusion tube 49 and balloon release member 50. In a preferred embodiment of the present invention, the proximal balloon release member connector 48 and the distal balloon release member connector 51 have an orifice or a plurality of orifices that allow blood to flow through perfusion tube 49 and consequently through balloon release member 50. In another preferred embodiment, Scapus ™ 46 comprises a substantially rigid solid rod. In one embodiment of the present invention, the Scapus ™ 46 and the balloon inflatube 45 are glued or fused together at a plurality of points along the length of the Scapus ™ 46. In another embodiment of the present invention, the Scapus ™ 46 contains one or more interior lights. In still another embodiment of the present invention,the balloon inflation tube 45 is placed within the Scapus ™ 46. In another embodiment of the present invention, the balloon inflation tube 45 is one of the internal lights of the Scapus ™ 46. In yet another embodiment of the present invention, the Scapus ™ 46 can be bent in a controlled manner, using a bending force. As used here, the bending force means the moment of bending that can be created by using the hands of the operator. The Scapus ™ 46 can not be bent by the many smaller forces imposed on the blood flow and the beating heart. The ScapusMR 46 can also incorporate joints or other bending means that allow the fold controlled by the operator of the ScapusMR 46 at predetermined points. Figure 5 also shows a distal embolic protection assembly 68. The distal embolic protection assembly consists of a frame 55 and porous pockets 56. In one embodiment of the present invention, the distal inlet portion of the filter mouth 53 includes a temporary valve. In one embodiment of the present invention, the delivery system 67 is inserted through a trocar 31 into the left ventricle 21 and advanced towards the native aortic valve of the heart 12. The delivery system 67 may be composed of a Scapus ™ 46 substantially rigid and a release member. TheCardiac valve prosthesis 100 is placed around balloon release member 50 and released to the target site of the implant. The length of the balloon release member 50 suitable for the purposes of the present invention will depend on the height of the prosthetic valve 100 to be implanted. Figure 6 shows a delivery system 67 comprising an infusion tube 49, a balloon delivery member 50, a Scapus ™ 46. Here, the Scapus ™ 46 is rigidly attached to the perfusion tube 49. In one embodiment of the present invention , the Scapus ™ 46 has a light that extends towards the balloon release member 50 and serves to inflate and deflate the balloon. The actuator sleeve 43 and the guidewire 41 is loosely placed within the perfusion tube 49. In one embodiment of the present invention, the distal embolic protection assembly 68, the actuator sleeve 43 and the guide wire 41 within the Activation sleeve 43 is movably positioned within the Scapus ™ 46 of the delivery system 67 and the balloon release member 50 shown in Figure 6. In still another embodiment of the present invention, the distal embolic protection assembly 68 may be collapsed and moved through the Scapus ™ 46 and the balloon release member 50. In one embodiment of the present invention, the delivery system shownin Figure 6 it is inserted through the trocar 31 in two steps: first the distal embolic protection assembly 68; second the release system 67 and the balloon release member 50. After the trocar 31 is inserted through the apex 18 of the heart 12, the distal embolic protection assembly 68 is moved in a collapsed configuration through the trocar 31 and the left ventricle 21 and placed downstream of the aortic valve. Once the distal embolic protection assembly 68 is in position, the distal embolic protection assembly 68 expands to seal the internal circumference of the aorta. The expansion takes place by moving the actuator sleeve 43 relative to the guide wire 41. All the circulation through the aorta will accordingly be filtered in the porous bag 56 of the distal embolic protection assembly 68. The guide wire 41 and the sleeve drive 43 extends from the proximal side of the distal embolic protection assembly 68 to the exterior of the body 10 and is accessible to the operator. In one embodiment of the present invention, the drive sleeve 43 can also be used as a guide wire to move the Scapus ™ 46 to its position. Thus in one embodiment of the present invention, the Scapus ™ release system can be loosely placed on a guide wire 41. In still another embodiment of the present invention, the tubeof perfusion 49 operates with the drive sleeve 43 to open and collapse the distal embolic protection catheter. The distal embolic protection mounts 68 can be inserted through the apex 18 of the heart 12. Those embodiments are summarized in co-owned US Application No. 10 / 938,410, incorporated herein by reference in its entirety. Distal embolic protection mounts 68 can also be inserted through arteries such as the femoral artery, such as those described by Macoviak, et al in US Application No. 10 / 108,245, incorporated herein by reference in its entirety. In another embodiment of the present invention, the distal embolic protection filter assembly 68 is introduced through the femoral artery and moves toward the aortic arch, positioned just downstream of the aortic valve as shown in Figure 7. release tube 66 is used to collapse the composite filter assembly of the filter frame 55 into a porous bag 56. In a further embodiment of the present invention, the guide wire 65 is attached to the frame 55 on the proximal side of the filter assembly 68 and continues through the aortic valve and out through the trocar 31 and out through the body 10. The guidewire 65 can be used to guide the delivery system 67 to its position through the trocar 31 and thevertex 18 of the heart. The manner in which the guide wire 65 is attached to the mouth of the filter 55 is for illustration purposes only. One skilled in the art will appreciate that there are many different ways of attaching a guide wire to the mouth 55 of the filter and different opening and closing mechanisms for the filter. Other aortic filter systems described in the prior art for insertion of the femoral artery may also be adapted for this procedure. In one embodiment of the present invention, the delivery tube 66 shown in Figure 7 is a Scapus ™ 46 delivery system. The Scapus ™ release system 46 can slide through the guide wire. The porous bag 56 can also be inserted and removed through the delivery system. Once the distal embolic protection assembly 68 has been placed in position, the Scapus ™ 46 of the release system 67 slides over the drive sleeve 43 through the apex 18 of the heart 12. In one embodiment of the present invention, the Release system 67 is released on guide wire 41 or 65, depending on the configuration of the distal embolic protection assembly. The balloon release member 50 is placed within the aorta and within the aortic valve and the aortic valve annulus. In a modality ofpresent invention, the distal embolic protection system 68 and the valve delivery system 67 is inserted through the vertex 18 together. A collapsed replacement heart valve prosthesis 100 is placed on the balloon release member 50. The delivery system 67 with the replacement prosthetic valve attached slides over the drive sleeve and is inserted into the access system orifice. and through the apex 18 of the heart 12. The balloon release member 50 with the attached heart valve prosthesis 100 is placed in the aorta and within the aortic valve and the aortic valve annulus. The balloon release member 50 expands by moving fluid through the balloon inflation tube 45. The balloon inflation tube 45 connects the fluid to the balloon release member 50. In one embodiment of the present invention, the device used to move the fluid through the balloon inflation tube 45 is a syringe. The balloon release member 50 expands in a radial direction when it is filled with fluid through the balloon inflation tube 45 causing the replacement prosthetic valve 100 to exert force against existing valvular lamellae and vessel walls. In one embodiment of the present invention, the valve replacement procedure described herein is performed more than once. A repeated procedure can, forexample, be performed on patients who can not tolerate open chest surgery. Once the heart valve prosthesis 100 is implanted, the balloon release member 50 is deflated and the valve delivery system 67 is removed from the body. The distal embolic protection assembly 68 is further removed from the body 10. In one embodiment of the present invention, the distal embolic protection assembly 68 and the valve delivery system 67 are removed from the body together. In one embodiment of the present invention, a distal embolic protection assembly 68 is not used. In yet another embodiment of the present invention, the distal embolic protection assembly 68 is left in the body for some time (up to 7 days) after the operation to make sure that the porous bag 56 of the distal embolic filter assembly 67 has collected all the debris. Figure 8 shows an implanted heart valve prosthesis 100 positioned at the position of the aortic valve. Figures 9, 10 and 11 show a Scapus ™ release system comprising a Scapus R 46, luer attachment 62, an infusion tube 49 and a balloon release member in the form of dog bone 50. The luer attachment 62 is attached to the proximal side of the ScapusMR 46 and can be used to direct the fluid to open andclosing the balloon release member 50. The balloon release member 50 is tightly placed around the perfusion tube 49. The perfusion tube 49 is attached to the Scapus ™ 46. The fluid can flow through the luer attachment 62, through Scapus ™ 46 and toward the balloon release member 50 to inflate and deflate the balloon. It is important to note that although the different inventions described herein are typically described with reference to the transapical valve implant, they can also be used in surgeries of non-latent hearts. The Scapus ™ release system, for example, can also be used in an open surgery situation. Thus, in one embodiment of the present invention, a Scapus ™ release system is used in non-latent heart surgeries. In another embodiment of the present invention, the Scapus ™ release system can be used in open chest surgery or robotic surgery.
Conversion of a Catheter to Scapus ™: Systems and Methods of the same The preferred delivery system to release valves and cardiac tools in a transapical or transcardiac procedure is a Scapus ™ release system. If a Scapus ™ release system is not available, however, it can be converted into a catheter in arelease system that is similar to the Scapus ™ release system. In one embodiment of the present invention, a rigid, substantially thin guide bar is inserted into the catheter to give it similar characteristics to those of a Scapus ™. The guide bar is loosely placed inside the catheter and occupies the space that in other circumstances would occupy a guidewire. But in opposition to a guide wire that can not resist bending, a guide bar is substantially rigid and can withstand any unintentional bending or twisting. A guide bar placed inside a catheter, in contrast to a catheter itself, provides sufficient rigidity, so that the resulting delivery system can more accurately and more accurately deliver a prosthesis during a latent heart procedure. The resulting release system is designed not to bend unless intended by the operator. The resulting release system may incorporate joints or other means for bending at predetermined points to allow the operator to adjust the direction or angle of the release path in a controlled manner. In another embodiment of the present invention a substantially rigid guide sleeve is loosely placed on the outside of the catheter to give it similar characteristics to those of a delivery systemScapusMR. The catheter is loosely placed inside the delivery sleeve or tube. The described release sleeve or tube is substantially rigid and can withstand any unintentional bending or twisting. A guide sleeve positioned loosely on a catheter, in contrast to a catheter itself, provides sufficient rigidity, so that the resulting delivery system can more accurately and accurately release a heart valve prosthesis 100 during a heart procedure. latent. The resulting release system is designed not to bend unless intended by the operator. The resulting release system may incorporate joints or other bending means at predetermined tips to allow the operator to adjust the direction or angle of the release path in a controlled manner.
Method for Folding the Valve and Preparing the Valve In one embodiment of the present invention, the heart valve prosthesis 100 is brought to the operating room in an expanded configuration. The heart valve prosthesis 100 is folded in diameter using beams known to those skilled in the art while the heart valve prosthesis 100 is loosely placed around a delivery member. The folding process occurs in the roomoperations or in the vicinity of the operating room. The heart valve prosthesis 100 is also released to the target site for implantation. In one embodiment of the present invention, the heart valve prosthesis 100 is brought into the operating room in a folded configuration. The heart valve prosthesis 100 is folded into the manufacturing facility in a careful, consistent and controlled manner. The heart valve prosthesis 100 can be folded directly onto the release member, such as the balloon release member 50. Alternatively, the heart valve prosthesis 100 can be folded to a size such that the internal diameter of the prosthetic heart valve 100 is equal to the external diameter of the release member. The heart valve prosthesis 100 remains in a folded configuration until the heart valve prosthesis 100 reaches the operating room. The crease of the heart valve prosthesis 100 in a controlled environment will minimize structural deterioration to the heart valve prosthesis 100 and simplify the procedure in the operating room. When it reaches the operating room, the folded heart valve prosthesis 100 is deposited around the release member, and the heart valve prosthesis 100 is further released to the target site for the implant.
Imaging Systems Since a transapical procedure does not provide a direct observation line, sufficient imaging of the heart, valves and other structures is important to provide diagnosis, guidance and feedback during the procedure. A ScapusM delivery system can be larger in diameter than a catheter and is thus more suitable for containing imaging transducers. Thus, in one embodiment of the present invention an image forming transducer is placed on the release system. In one embodiment of the present invention, the imaging transducer is placed within the delivery system. In another embodiment of the present invention, the imaging transducer is positioned just proximal and / or distal to the delivery member. An external image-forming transducer may be provided to view the field of operation and imaging systems may be used at any time or throughout the duration of the surgery. The valvuloplasty assembly may include IVUS or other imaging detectors. That imaging technology can be used to inspect the native valve annulus and the required size of the heart valve prosthesis 100 after the valvuloplasty has been completed.
Imaging systems are well known to those skilled in the art and include transesophageal echo, transthoracic echo, intravascular ultrasound imaging (IVUS), intracardiac echo (ICE), or an injectable dye that is radiopaque. Cinefluoroscopy can also be used. The placement of the imaging probes in relation to the balloon release member 50 has been previously described in the co-owned PCT / US / 04/33026 filed on October 6, 2004 incorporated herein by reference in its entirety.
Valve Removal Systems The present invention also provides a method or system for removing the native valve with a valve removal device by access through the apical area of the heart. By way of example, the removal of the valve can be effected as taught in Copending US Patent Application Serial No. 10 / 375,718 and 10 / 680,562, which are hereby incorporated by reference as set forth in full. In one embodiment of the present invention, the method may further comprise the step of removing at least a portion of the patient's heart valve by means of cutting tools that are placed in the Scapus R. In another aspect of the present invention, the toolThe shear can be made of an electrically conductive metal that provides radio frequency energy to the cutting tool to improve the removal of the valve. Ablation with high frequency energy is well known in the art. In another embodiment of the present invention, the release member includes cutting means comprising a plurality of jaw-shaped elements, each jaw-shaped element having a pointed end which allows the jaw-shaped element to cut through to the jaw member. minus a portion of the native valve. In another aspect, the cutting means comprises a plurality of electrode elements, wherein radio frequency energy is released to each electrode element, allowing the electrode element to cut through at least a portion of the native valve. In a further aspect of the present invention the cutting means comprise a plurality of ultrasound transducer elements, wherein the ultrasound energy is released to each transducer element allowing the transducer element to cut through at least a portion of the native valve. A Scapus ™ with a valve removal system placed on it is inserted through the vertex and placed substantially in the vicinity of the aortic valve. The lamellae of the native valve and remains (forexample, calcium and valve lamellae) are removed. The parts that are not contained by the valve removal systems are trapped in the distal embolic protection filter.
Distal Embolic Protection System The present invention also provides devices and methods for providing distal embolic protection during the procedure. Figure 5 and Figure 6 show examples of distal embolic protection mounts 68 and their relation to delivery system 67. It is important that the distal embolic protection filter provide means for trapping embolic material and debris. In one embodiment, it is also desirable that the distal embolic protection filter provide a temporary valve. The filter and the temporary valve assembly prevent the backflow of blood, embolic material and debris, also allowing the flow of fluid to the filter during surgery. The temporary valve can also temporarily perform the work of an adjacent cardiac valve, such as the aortic valve. Thus, in one embodiment of the present invention, the distal embolic protection assembly 68 provides a filtration member for capturing embolic material that concurrently functions as a temporary valve. Mounts of distal embolic protection 68used in both transapical and percutaneous procedures can be compressed and expanded to allow entry into small blood vessels and other body cavities. Combining both a one-way valve and a filter basket mechanism requires a sufficient amount of equipment which makes it difficult to compress the filter down enough to be used during transapical and percutaneous procedures. Figure 12 shows a subcomponent of a distal embolic protection filter system that incorporates both a filter and the function of a temporary valve. The proximal mouth 73 of the filter consists of a proximal frame 74 which pushes against and makes a seal with the surrounding vasculature. The proximal frame 74 can, for example, push and seal against the inner wall of the aorta, causing all the emboli and debris to flow through the filter assembly. In one embodiment of the present invention, the proximal frame 74 is made of a shape memory alloy such as Nitinol, which allows it to expand towards its position. The distal end 76 of the filtration sub-assembly is shown open. In other words, the remains not captured in the filter mesh 78 can continue through the distal end 76 and the sub-assembly of the filter, moving along the distal shell 75. In one embodiment of the present invention, the distal shell 75 is made ofan alloy with shape memory like Nitinol, which allows it to maintain an open configuration. Figure 13 shows three interconnected filter sub-assemblies shown in Figure 12. Although three sub-assemblies are shown, any number of two or more sub-subassemblies will work. The length of the frame proximal to the distal frame of each sub-assembly is slightly different, thus separating the filter meshes from the different filter sub-assemblies 78, 79 and 82. The proximal frame 74 is shared by the different filter sub-assemblies. Thus, in one embodiment of the present invention, a plurality of filter sub-assemblies are interconnected at the larger entrance of the filters, while the downstream sides of the sub-subassemblies have smaller openings that allow the remains to flow to their through. In one embodiment of the present invention, the outermost filter assembly is closed at the downstream end. Therefore, the device provides less flow restriction when blood flows into the porous pockets (ie, downstream from the aortic valve) as opposed to the reverse. This means that the device also functions as a one-way valve.
Valve Decalcification Systems The formation of atherosclerotic plaques and injurieson cardiovascular tissue, such as blood vessels and heart valves, is a major component of cardiovascular diseases. A variety of different methods have been developed to treat cardiovascular diseases associated with plaques and calcified atherosclerotic lesions. These methods include mechanical removal or reduction of the injury, such as bypass surgery, balloon angioplasty, mechanical detachment, atherectomy, and valve replacement. Plaques and calcified atherosclerotic lesions can also be treated by chemical means which can be provided to the affected area by various catheter devices. For example, US Patent No. 6,562,020 to Constantz et al., Which is incorporated herein by reference in its entirety, discloses methods and systems for dissolving calcified vascular lesions using an acidic solution. A catheter releases an acidic fluid into a localized vascular cycle. This system can, for example, disqualify a calcified heart valve by applying the acid solution (such as hydrochloric acid, etc.). The current percutaneous anticalcification system described by Constantz et al., Is inserted through the femoral artery. Insertion through the femoral artery is not practical in the case of a transapical proceduresince another incision is required in the patient. The system of Constantz et. to the. it can be adapted so that the release member that controls and operates the decalcification system moves from the proximal side (ie, on the operator side as in the case of femoral access) to the distal side. Accordingly, in another embodiment of the present invention, the methods and devices of the present invention can be adapted to provide a valve decalcification system, where the Scapus ™ system is capable of providing the solution solution to the treatment site for access to through an apical area to the heart. Suitable solution solutions are known in the art and are generally characterized as those which are capable of increasing the concentration of protons in the treatment site to a desired level sufficient to dissolve at least partially the mineral component of the calcified atherosclerotic lesion. A Scapus system that is transapically released can also provide means to isolate the treatment site to prevent the solution from dissolving into the patient's circulatory system. Thus, in one embodiment of the present invention, the decalcification systems described and incorporated by reference above are adapted to be placed in aScapus as opposed to a catheter. Those means for isolating the treatment site may include a barrier, such as a double balloon system over the catheter that is inflated on both sides of the treatment site. Figure 14 shows that delivery system where a multiluded ScapusMR 46 is connected to an infusion tube 49 which in turn is connected to two balloons, a proximal balloon 92 and a distal balloon 93. The two balloons are shown inflated and in FIG. intimate contact with the walls of the aorta 94. In one embodiment of the present invention, the perfusion tube 49 is not present and the proximal balloon 92 and distal balloon 93 are in intimate contact with a Scapus ™ 43. The fluid can flow to through Scapus ™ 46 to inflate the proximal balloon 92 and distal balloon 93 as well as to provide the dissolution solution to the treatment site confined by proximal balloon 92 and distal balloon 93.
Valve Within an Artificial Valve: Systems and Methods Thereof An object of the present invention is to provide systems and methods for implanting an expandable heart valve within a target valve located within the heart. This procedure is beneficial in older or sick patients who have already received aValve implant previously and you can not or do not want to experience the trauma of another open heart surgery. Implantation of an expandable heart valve within an existing white heart valve allows the use of minimally invasive implant techniques, such as percutaneous or transapical valve implant techniques. Current methods and systems are distinctly different from those described in Andersen et al., In U.S. Patent No. 6,582,462, which describes the implant of a valve in a bodily channel or vasculature. Andersen attempts and aims to describe an expandable valve that is placed within a bodily channel or vasculature and uses the intimate contact created within the vasculature, the body canal or native valve as a support to allow the implant. In the present invention, an expandable heart valve prosthesis 100 is implanted within a previously implanted artificial heart valve prosthesis and uses the intimate contact created with the heart valve prosthesis previously implanted as a support. If the previously implanted heart valve prosthesis is removed, the expandable heart valve prosthesis 100 located within the previously implanted heart valve prosthesis will be removed concurrently. In one embodiment of the present invention, an expandable heart valve prosthesis 100 is mounted withinof a previously implanted heart valve prosthesis located inside the heart. The expandable heart valve prosthesis 100 can be any valve that can be released in a minimally invasive manner, such as percutaneously or transapically released valves. In one embodiment of the present invention, the expandable heart valve prosthesis 100 is an expandable heart valve with a balloon. In another embodiment of the present invention, the expandable heart valve prosthesis 100 is the heart valve 3F Entrata ™. In another embodiment of the present invention, the expandable heart valve prosthesis 100 is a self-expanding cardiac valve. In yet another embodiment of the present invention, the expandable heart valve prosthesis 100 is an expanded valve using some other mechanical or actuation means. The previously implanted heart valve prosthesis can be any native or artificial valve. In one embodiment of the present invention, the previously implanted heart valve prosthesis is a mechanical valve. In another embodiment of the present invention, the previously implanted heart valve prosthesis is a tissue valve. The previously implanted heart valve prosthesis can also be made of polyurethane or be a modified tissue valve. In one embodiment of the present invention, the heart valve prosthesispreviously implanted can be an expandable heart valve. In yet another embodiment of the present invention, more than one expandable heart valve prosthesis 100 may be implanted within a previously implanted heart valve prosthesis. Therefore, multiple minimally invasive cardiac valve releases can be conducted without removing the existing valve or existing valves. The previously implanted heart valve prosthesis can be an aortic valve, mitral valve, pulmonary valve or tricuspid valve. The previously implanted heart valve prosthesis can be the homoinjed valve or a xenoinjed valve. Examples of previously implanted heart valve prostheses include, but are not limited to, the Edwards Perimount Valve, Edwards BioPhysio Valve, the Medtronic Hancock I Valve, the Medtronic Hancock MO Valve, the Medtronic Hancok II Valve, the Medtronic Mosaic Valve , the Medtronic Intact Valve, the Medtronic Freestyle Valve, the St. Jude Toronto Stentless Porcine Valve (SPV), and the St. Jude Prima Valve. The expandable heart valve prosthesis 100 can be made to fit well within the previously implanted heart valve prosthesis. In one case, the posts of the expandable heart valve prosthesis 100 are coordinated to place the posts of the valve prosthesis.cardiac implant previously Thus, in one embodiment of the present invention, the posts of the expandable heart valve prosthesis 100 equalize the orientation of the poles of the previously implanted heart valve prosthesis. In an embodiment of the present invention. The interposte separation angles of the expandable heart valve prosthesis 100 add up to 360 °. In other embodiments of the present invention, the interposte separation angles of cardiac valve prostheses 100 is 120 °, 120 °, and 120 °; or 135 °, 120 °, and 105 °; or 135 °, 105 °, and 120 °; or 120 °, 135 °, and 105 °; or 120 °, 105 °, and 135 °; or 105 °, 135 °, and 120 °; or 105 °, 120 °, and 135 °. Figure 15 shows an exploded view of Figure 16, where the heart valve prosthesis 100 is shown implanted within a previously implanted heart valve prosthesis 101. In a preferred embodiment, the flow ring or ring 105 of the prosthesis of heart valve 100 is aligned with the flow ring or ring 115 of the previously implanted heart valve prosthesis 101. In another preferred embodiment, the commissural posts 106 of the heart valve prosthesis 100 are aligned with the commissural posts 116 of the heart prosthesis. previously implanted heart valve 101. It should be noted that although reference is here made to a heart valve 100 implanted in a prosthesis ofpreviously implanted heart valve 101 within the aorta, it is intended that those valve procedures encompass any location within the heart 12, and not be limited to the aorta. In a preferred embodiment of the present invention, the previously implanted heart valve prosthesis 101 is of the same size or larger size as the expandable heart valve prosthesis 100. For example purposes, if the previously implanted heart valve prosthesis 101 is of 27 mm, the expandable heart valve prosthesis 100 is 25 mm or 27 mm in size. Thus, in one embodiment of the present invention, the expandable heart valve prosthesis 100 is of the same size as the previously implanted heart valve prosthesis 101. In another embodiment of the present invention, the expandable heart valve prosthesis 100 is more larger than the previously implanted heart valve prosthesis 101. In another embodiment of the present invention, the expandable heart valve prosthesis 100 is smaller than the previously implanted heart valve prosthesis 101. Clinical records will specify the exact size used during implantation. previous. The size of the previously implanted heart valve prosthesis 101 will be thus known. In vitro tests will show the best size of the expandable heart valve prosthesis 100 fora specific type size of target or target valve. The expandable heart valve of optimal size can thus be determined from the clinical records of the previous heart valve implant. Thus, in one embodiment of the present invention, the size of the expandable heart valve prosthesis 100 to be used is determined from the clinical records of previous implants. In one embodiment of the present invention, the expandable stent is implanted into a previously implanted heart valve prosthesis 101 prior to implantation of the expandable heart valve prosthesis 100. In another embodiment of the present invention, valvuloplasty is used to expand the valve orifice. the previously implanted heart valve prosthesis 101 before implantation of an expandable heart valve prosthesis 100 or before implantation of an expandable stent. Any delivery system for releasing the expandable heart valve prosthesis 100 can be used. In one embodiment of the present invention, the delivery system is a catheter. In another embodiment of the present invention, the delivery system is a Scapus ™. The expandable heart valve prosthesis 100 can be released through any access point to the heart. In one embodiment of the present invention, the expandable heart valve prosthesis 100 is released in a mannerminimally invasive In one embodiment of the present invention, the expandable heart valve prosthesis 100 is percutaneously released. In another embodiment of the present invention, the expandable heart valve prosthesis 100 is transapically released.
Valve Insertion System without Sutures and Methods for It The benefits of the Scapus ™ valve release system can be used in the case of self-expanding valves. Therefore, the delivery system can be used for percutaneous valve release, transapical valve release, transcardiac release. In addition to these release techniques, the Scapus ™ release system can be used in more invasive cardiac procedures such as open-heart procedures. The Scapus ™ release system is well suited to release the 3F Enable Aortic Heart Valve ™ and the other valves described in the co-pending US applications entitled "Minimally Invasive Valve Replacement System" with the following application numbers: 10 / 680,733; 10 / 680,719; 10 / 680,728; 10 / 680,560; 10 / 680,716; 10 / 680,717; 10 / 680,732; 10 / 680,562; 10 / 680,068; 10 / 680,075; 10 / 680,069; 10 / 680,070; 10 / 680,071; and 10 / 680,567,all incorporated here as a reference in its entirety.
Valve Insertion System without Sutures and Methods for the same. Cardiac valve replacements of current tissues gradually calcify after being implanted in the heart. This is also the case when cardiac replacement valves are implanted in animals such as pigs or sheep. Indeed, replacement heart valves that are intended for human use typically calcify rapidly when implanted in animals such as pigs or sheep. Due to the difference in flow dynamics, physiology and biochemistry, commercially available heart valves work best will typically show signs of calcification in pigs and sheep within 10-200 days. The standard animal models used for testing preclinical valves are often sheep, but pigs can also be used. Adolescent sheep have a high propensity to calcify prosthetic valves. The fact that the heart valves placed in the heart of certain animal models rapidly calcify can be used as a basis to create models of calcified animals for use in the development and testing of heart valves.
Valve replacement by open heart surgery in adolescent sheep typically results in less than 40% success / survival in the aortic position, due to very small valve sizes and the use of complete deviation. Valve replacement by open-heart surgery in adolescent sheep typically results in a success of more than 80% / survival in the mitral position due to larger valve sizes and the use of latent heart, partial deviation. The placement of replacement valves at the mitral position during animal testing is not used to reduce costs but is considered a "worst case" position due to the greater back pressure. The replacement of aortic and mitral valves is therefore often placed in the mitral position during animal studies. Accordingly, an object of the present invention is to provide methods and systems for the creation of a calcified animal model. The commercially available tissue valves are implanted first in adolescent sheep. The animals survived 10-200 days and performance was evaluated. Due to the increased propensity for calcification in animals, all implanted valves are expected to be stenotic and / or incompetent due to calcification of the tissue laminae. Sheep can be evaluated at regular intervals using echo.
Another objective of the present invention is to use the calcification model described above in the development and testing of heart valves. The use of transapical percutaneous implant techniques places replacement operation valves inside calcified valves of adolescent ewes. The survival of the test animals for 20 weeks (150 +/- 10 days) or as required by regulatory authorities. Verification of replacement valves, necropsy, pathology and post mortem histology. The present invention can be divided into two phases: I. Create a calcified animal model by replacing the native valves of adolescent ewes with commercially available valves and surviving the animals for 10-200 days. II. Minimally invasive valve implants within calcified valve orifices using a minimally invasive valve procedure. In phase I of the invention, a calcified animal model is created by replacing the native valves of adolescent ewes with commercially available valves and keeping the animals alive. In one embodiment of the present invention, the heart valve replacement procedure is a pumping procedure. In another form ofThe present invention, the cardiac valve replacement procedure is a minimally invasive cardiac valve procedure, such as the percutaneous cardiac valve replacement procedure, to a transapical valve procedure. In the latter embodiment, the method described here would allow the testing of a minimally invasive repeated heart valve procedure. In one embodiment of the present invention, the cardiac valve replacement procedure is conducted endoscopically. In yet another embodiment of the present invention, the cardiac valve replacement procedure is conducted using robots. In one embodiment of the present invention, drugs are used to adjust the rate of calcification. In another embodiment, the valve implanted during phase I is coated with a chemical substance used to adjust the rate of calcification. Any valve can be implanted during phase I. In one embodiment of the present invention, the implanted valve is a tissue valve. In another embodiment of the present invention, the implanted valve is a mechanical valve. Implanted heart valves can include aortic valves, mitral valves, tricuspid valves, or pulmonary valves. A replacement valve may not necessarily be implanted in its intended position. As an example, an aortic valve can be implanted in themitral position of the animal. Thus in one embodiment of the present invention, a replacement aortic valve is implanted in the mitral position. In one embodiment of the present invention, multiple valves are implanted in different positions at the same time. In a preferred embodiment of the present invention, the valves are implanted in animals whose dynamic and flow cardiac physiology, as well as biochemistry, are equal to those of humans as much as possible. Sheep and pigs are thus frequently used for the testing of heart valves. Thus, in one embodiment of the present invention, the sheep is used as the model animal. In another embodiment of the present invention, pigs are used as a model animal. Any other primate can be used as an animal model. In one embodiment of the present invention, the animals of the subclass euteria are used as an animal model. In another embodiment of the present invention, animals of the anthropoid suborder (e.g., monkeys and apes) are used. The age of an animal affects the rate of calcification. Thus, in one embodiment of the present invention, the age of the animal is equivalent to that of an adolescent. In another embodiment of the present invention, the animals used are adults. An objective of the present invention is to makesurvive the animals sufficiently at the end of phase II, so that the preclinical regulatory requirements for the different regulatory bodies are satisfied. It is expected that some animals will not survive valve replacements during phase I. In addition animals may perish during the duration of phase I. More animals will perish during the phase II replacement implants as well as during the duration of phase II. In a preferred embodiment of the present invention, an excessive number of animals is used to initiate phase I so that a sufficient number of animals survive all the way through phase II. The exact number of animals required for the start of phase I depends on numerous variables including the operator, the type of animal, the type of procedure. An objective of the present invention is to verify the progress of calcification and diseases related to the valves implanted. Different types of verification are used such as ultrasound, MRI, CT, and cinefluoroscopy during the course of phase I and phase II. In one embodiment of the present invention, echo is used at 60, 90 and 120 days during phase I to verify the valves implanted. . In one embodiment of the present invention, the animals in phase I survive for 90 days and 120 days. The length of phase I depends on factors such as what type ofanimal is used and what type of tissue valves are used. The valves can be checked during phase I. It may be possible to proceed to phase II earlier on the basis of the in vivo evaluation. In phase II of the invention, the valves are implanted within calcified valve orifices. Implant procedures include, but are not limited to, minimally invasive valve procedures, percutaneous valve procedures, transapical valve procedures, valve-by-pump procedures, endoscopic valve procedures, and robotic valve procedures. In one embodiment of the present invention, drugs are used to adjust the rate of calcification. In another embodiment, the valve implanted during phase II is coated with a chemical substance used to adjust the rate of calcification. Any valve can be implanted during phase II. Tissue valves include, but are not limited to, tissue valves, mechanical valves, aortic valves, mitral valves, tricuspid valves, pulmonary valves. A replacement valve may not necessarily be implanted in its intended position. As an example, an aortic valve can be implanted in the mitral position of the animal. Thus, in one embodiment of the presentinvention, a replacement aortic valve is implanted in the mitral position. In one embodiment of the present invention, the animals in phase I survive for 20 weeks (150 +/- 10 days). The length of phase II depends on the guidelines provided by the regulatory bodies. In one embodiment of the present invention, the minimally invasive valve release is conducted using the SCAPUS * 4 release system. In one embodiment of the present invention, the valve used is the Entrata ™ valve of 3F Therapeutics, Inc. In one embodiment of the present invention, a balloon in the inferior vena cava is used to regulate the pressure during the procedure. In one embodiment of the present invention, the replacement valve in phase II sits within the calcified valve orifice of the valve replacement conducted in phase I. In another embodiment of the present invention, the replacement valve in the phase II sits just upstream of the calcified valve orifice of the valve replacement conducted in phase I. In another embodiment of the present invention, the replacement valve in phase II sits just downstream of the calcified valve orifice of the valve. valve replacement conducted in phase I. Obviously, numerous variations can be made andmodifications without departing from the spirit of the present invention. Therefore, it should be clearly understood that the forms of the present invention described above and shown in the Figures of the accompanying drawings are illustrative only and are not intended to limit the scope of the present invention. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.