Transcatheter resection devices and methods for native or bioprosthetic heart valves

Abstract

The invention relates to a resection device for a natural or biological prosthetic heart valve (6), comprising a leaflet grasping system (5, 8) and a leaflet cutting device (9), said grasping system (5, 8) and said cutting device (9) being coaxially and longitudinally movable relative to each other, and wherein said grasping system (5, 8) is longitudinally oriented, characterized in that said grasping system (5, 8) comprises a fixed part (5) and a rotating part (8); said fixed part (5) being adapted to grasp a leaflet face (6b) and said rotating part (8) being adapted to grasp an opposite leaflet face (6a).

Description

Technical Field

[0001] This invention relates to the removal of natural or biological prosthetic heart valves, typically stenotic valves, via a catheter-based minimally invasive procedure. Background Technology

[0002] Over the past 30 years, increased life expectancy in Western countries has led to an exponential increase in cardiac surgery in older patients. In this population, aortic stenosis is the most common acquired heart disease, with a prevalence of 4.8% in patients aged >75 years and representing >60% of cardiac surgery indications in older patients. Although many authors have reported good outcomes from routine aortic valve replacement (AVR) in older patients, many patients are refused surgery due to the high surgical risk. In this vulnerable population, transcatheter aortic valve implantation (TAVI) can be a good compromise for achieving good outcomes while minimizing morbidity and mortality[8].

[0003] Transcatheter aortic valve implantation (TAVI) was introduced into clinical practice in 2002 as a rescue method for patients presenting with symptomatic severe aortic stenosis but not meeting the criteria for conventional aortic valve resection (AVR). This technique allows for the implantation of a balloon-expandable bioprosthetic without resection of the native aortic valve. Several complications have been described due to the residual, highly calcified valve being compressed between the aortic wall and the implant's stent. This can lead to deformation and paravalvular leakage of the metallic stent, the risk of coronary ostial occlusion, or central and peripheral embolism of valve fragments. In recent reports, it has been hypothesized that it is necessary to resect the native calcified aortic valve prior to TAVI to avoid those complications, and several authors have reported novel experimental approaches to endovascular aortic valve resection to achieve the same goal.

[0004] In 2002, Cribier et al. crossed the forefront of treating severe aortic stenosis with the first human percutaneous aortic valve implantation (TAVI). However, TAVI can lead to serious complications, and the resection of the non-calcified natural valve presents problems with paravalvular leaks, cerebral embolism, and the need for permanent pacemaker implantation.

[0005] The mechanisms of these complications may be related to the lack of removal of the natural aortic valve. The incompressibility of the leaflet calcium causes misalignment of the TAVI on the valve annulus, leading to paravalvular leakage. Excessive compression of the calcified natural leaflet on the conduction tissue causes atrioventricular block and the need for neoplasm implantation. Fragmentation of the leaflet calcium during TAVI positioning and deployment may produce fragments that could cause embolisms in the brain, coronary system, or other locations.

[0006] Another cause of cerebral embolism may be related to the fact that TAVI placement in a naturally calcified valve creates a dead space between the natural valve leaflet and the aortic wall.

[0007] This space can be a microenvironment for thrombi and debris that can later be embolized. This can explain the high rate of cerebral embolism even up to 2 years after TAVI. If the natural leaflet is removed, this space can be continuously flushed by the blood from the TAVI procedure. The incidence of thromboembolic neurological events at 30 days, 1 year, and 2 years, reported by investigators in the Partner trial, was 5.5%, 8.3%, and 11.2%, respectively. Data from the UK TAVI registry report a stroke rate of 2.8–4.1% after TAVI. Furthermore, a high proportion of asymptomatic local ischemic injury has been shown in diffusion-weighted magnetic resonance imaging (MRI) studies, ranging from 66–71%. Astarci et al. reported a 95% or even higher proportion of asymptomatic local ischemic injury detected by MRI. This high proportion of asymptomatic local ischemic injury is associated with embolism of debris during TAVI. Removal of the naturally calcified aortic valve prior to TAVI should reduce the incidence of complications related to calcium loss and damage to surrounding structures due to compression. The AVC proposed by Kiel's group and the collection chamber proposed by Essen and Brussels' group are based on balloon sealing systems. Unlike the other two devices, which require additional tools to protect the coronary ostium from fragment embolism and a proper aspiration system to remove the resected fragments after resection, the device designed by Brussels' group allows for direct collection of fragments during resection, up to the lumen between the nitinol blade and the supravalvular balloon.

[0008] However, in all these systems, the balloon can be damaged during the resection procedure, thereby impairing the surgery and exposing the patient to a large amount of embolism from debris.

[0009] Another important factor to analyze is the time required to perform the resection. Salizzoni et al. used an animal model (in vivo pigs) to test the effect of pump-free aortic valve resection in preparing for aortic valve implantation. The removal of the aortic valve caused significant aortic regurgitation, associated with an immediate decrease in systolic and diastolic arterial pressures, which resulted in equalization of left ventricular end-diastolic pressure. Coronary blood flow was reduced by 50%, and the average occurrence of ischemic changes in the heart on ECG was 30.8 seconds.

[0010] Quaden et al. (Kiel group) reported resection times of 2.3 ± 0.3 to 12.2 ± 0.8 minutes for three leaflets using a high-pressure water jet scalpel and 5.5 ± 2.3 to 6 ± 3.5 minutes for each leaflet using a thulium:YAG laser system. Compared to their work, the blade-based resection system has shorter resection times and appears to be more suitable for minimally invasive aortic valve replacement and seems more realistic for an endovascular approach prior to TAVI implantation in pump-free heart surgery.

[0011] Compared to the work of Wendt et al., Astavici's report indicates that the force required to remove calcified human valves is higher. One possible explanation reported by the authors is the fact that calcification in human valves may be stronger than in commercially available biological prostheses. A second explanation might be that natural calcification over many years could result in stronger calcification than artificial calcification performed over several weeks. Finally, the cause may also be related to the characteristics of the devices and blades that could affect the cutting process.

[0012] An ideal device should be easy to operate and easy to remove in case of surgical failure. It should provide rapid and precise resection of severely calcified valves without generating debris during resection. It should include an aortic isolation chamber to collect the resected valve and protect the coronary ostium. More importantly, it should be compatible with a TAVI implantation system.

[0013] Blade-based devices appear suitable for rapid endovascular resection within seconds in a beating heart without a pump, whereas laser and waterjet devices require significantly longer resection times and necessitate cardiopulmonary bypass or ventriculoperitoneal shunts during resection. Brecht et al. proposed a blade-based device that includes a resection and implantation system. While the idea for this device appears promising, the lack of protection of the coronary ostium during resection could expose patients to coronary embolism.

[0014] Furthermore, balloon-based isolation systems can be easily damaged during resection, thereby compromising the entire procedure.

[0015] Finally, another potential advantage of these devices should be emphasized. While resection prior to TAVI is the ultimate goal, resection devices can be helpful during unilateral prosthetic aortic valve implantation. The only benefit of unilateral valves compared to standard biological prostheses is the time gained during placement. The use of rapid resection devices can enhance the effectiveness of unilateral procedures.

[0016] In summary, the resection of calcified natural aortic valve or bioprosthetic and the implantation of a specially designed next-generation TAVI can bring several clinical advantages to patients compared with current TAVI procedures:

[0017] a) Paravalvular leakage (PVL) is significantly reduced because the prosthesis fits better into the defined and regular annular ring;

[0018] b) Reduce the incidence of atrioventricular (AV) block requiring pacemaker implantation;

[0019] c) Reduces coronary ostial occlusion and decreases the dead zone between the prosthetic leaflet and the aortic root. In TAVI, the natural leaflet is pushed toward the coronary ostium;

[0020] d) Reduce continuous embolism of calcium fragments. Neurological complications persist even 2-3 years after TAVI implantation;

[0021] e) Significantly reduces patient-prosthesis mismatch (PPM). Resection of the natural valve allows for the implantation of a larger valve prosthesis, reduces the risk of PPM, and leaves room for further resection of the prosthetic valve in the future. Summary of the Invention

[0022] The present invention provides a different and improved device for removing natural or biological prosthetic heart valves.

[0023] It also includes the method of using the device.

[0024] This invention is particularly applicable to the replacement of atrioventricular valves or tricuspid valves.

[0025] Such valves gradually harden during calcification due to malnourished tissue calcification. The progressive pathological result is the infiltration of hydroxyapatite crystals into the fibro-elastic structure of the valve leaflets. The resulting tissue sometimes has a stone-like consistency and is particularly difficult to remove during heart valve replacement surgery.

[0026] The use of the device according to the invention is based on the direct cutting of the diseased valve by means of special surgical scissors. The removal of the diseased valve is accomplished by accurately removing any remaining calcified protruding boulders in order to prepare the implantation site for suturing the next prosthetic implant.

[0027] The purpose of this invention is to simulate surgical valve resection through non-invasive transcatheter interventional surgery. This retrieval device is suitable for performing resection of diseased natural valves or degenerated bioprosthetic valves via transcatheter surgery without any support from cardiopulmonary bypass.

[0028] The basic concept of this device consists of three surgical steps that address key issues that still exist in current TAVI procedures. The first step is to lock the stenotic leaflet using a grasping system positioned within the natural valve. The second step is to safely, quickly, precisely, easily, and sharply cut the diseased natural valve or bioprosthetic leaflet. The third step is to safely remove the resected valve device with minimal obstruction within the same catheter, without fragment embolism or with minimal fragment embolism. This removal procedure is intended to be performed in the presence of an embolism protection device (not described here), positioned in the ascending aorta to prevent cerebral and peripheral embolism.

[0029] In a narrow natural valve, the result of the valve removal procedure is a predetermined-sized annular aortic ring, into which a seamless transcatheter aortic bioprosthetic can be implanted in the same procedure. If the removal procedure is performed on a narrow, previously implanted bioprosthetic valve, the end result is a bioprosthetic stent without any biological functional components. In this case, the bare bioprosthetic stent can be used as an anchoring support for implanting a conventional TAVI bioprosthetic.

[0030] Providing temporary valve support can be successfully achieved without removing the natural heart valve.

[0031] More specifically, the present invention relates to a transcatheter resection device for natural or biological prosthetic heart valves, comprising a leaflet grasping system and a leaflet cutting device, the grasping system and the cutting device being coaxial and longitudinally movable relative to each other, wherein the grasping system is longitudinally oriented, characterized in that the grasping system comprises a fixed portion and a rotating portion; the fixed portion is adapted to grasp the leaflet surface, and the rotating portion is adapted to grasp opposing leaflet surfaces.

[0032] According to a preferred embodiment, the natural valve to be removed is inside the cutting device and outside the gripping system.

[0033] The gripping system may advantageously include barbs that, when interacting with the natural leaflet, are oriented proximally and at different angles.

[0034] When the grasping system is positioned within the natural valve, it can expand to the desired diameter in a self-expanding mode and / or via a mechanical support or balloon. The grasping system also includes a fixed portion and a rotating portion; the fixed portion is adapted to grasp the leaflet surface, such as the ventricular side, and the rotating portion is adapted to grasp the opposing leaflet surface, i.e., the fibrous membrane side. The device according to the invention can also advantageously include an anchored valve stent having a distal portion providing temporary valve function and a proximal portion including the grasping system.

[0035] Preferably, the anchoring valve stent has a funnel shape. With this configuration, the gripping system is located within the narrow portion of the anchoring valve stent.

[0036] In another embodiment, the grasping system is detached from the temporary valve within the anchoring valve stent. In this case, the function of the temporary valve can be allocated to a seamless transcatheter valve prosthesis, which will be repositioned at the end of the procedure and remain in place as a definitive prosthesis.

[0037] The present invention also relates to a method of using the device as described above. In this case, it includes the following steps:

[0038] - Oriented towards the proximal side of the leaflet,

[0039] - The petals are grasped by the grasping system.

[0040] - Cut the petals using a cutting device.

[0041] - Remove the cut leaflets.

[0042] When anchoring is still used, the anchor valve stent is positioned before the proximal oriented leaflet.

[0043] The petals are grasped on two surfaces using the fixed and rotating parts of the gripping system.

[0044] Advantageously, a unibody transcatheter bioprosthetic valve can be located after an incision is made to remove the nonfunctional leaflet portion. Attached Figure Description

[0045] In this chapter, the invention will be better understood through some non-limiting illustrative examples.

[0046] Brief description of the attached diagram:

[0047] Figure 1a An anchored valve stent with a distal portion containing a prosthetic valve is shown.

[0048] Figure 1b A proximal section of an anchored valve stent is shown, illustrating the stent structure and gripping elements for locking the natural valve leaflet.

[0049] Figure 1c The distal section of the anchored valve stent is shown, as is the trilobed structure of the prosthetic valve.

[0050] Figure 2 The fixed portion of the leaflet holding system is shown (the rotating portion is not shown in the figure). The inner portion of the anchored valve stent is provided with angled barbs that penetrate the ventricular layer, designed to keep the leaflets secure and lock them in place to prevent embolism after cutting.

[0051] Figure 3a and 3b The complete gripping system is shown, illustrating the upper portion of the anchoring valve stent equipped with barbs. This upper portion rotates almost 180° and grips the fibrous membrane layer of the valve leaflets, thereby allowing complete locking of the leaflets.

[0052] Figure 4 A cutting tool is shown, with its blade in the distal portion.

[0053] Figure 5 The excision cutter is shown placed above the anchor valve stent.

[0054] Figure 6The excision cutter is shown after the removal of the natural leaflet.

[0055] Figure 7 An anchored valve stent is shown, in which a temporary prosthetic valve is positioned above the cutting edge and the leaflets are captured. The resection cutter is not shown.

[0056] Figure 8 A valve resection and replacement system is shown. The system has two handles, one for controlling the navigation catheter and the other for resecting / removing the natural valve, and a third (closest to the operator) handle for controlling / releasing a dedicated TAVI.

[0057] Figure 9 The insertion of a guidewire through a natural valve is shown.

[0058] Figure 10 This illustrates the positioning of the navigation catheter into the aorta.

[0059] Figure 11 A navigation catheter passing through a natural valve is shown.

[0060] Figure 12 The expander removed from the navigation duct is shown.

[0061] Figure 13 The illustration shows the deployment of a prosthetic valve beneath a natural valve.

[0062] Figure 14 The intermediate deployment of the anchored valve stent is shown, illustrating the intermediate portion of the natural leaflet anchored with barbs.

[0063] Figure 15 The diagram shows the rotary gripping system locking the leaflets from the fiber membrane side after full deployment.

[0064] Figure 16 The image shows the resection cutter positioned outside the resection valve stent.

[0065] Figure 17 This illustrates an ongoing surgical procedure to remove a natural leaflet. The resection cutter is pushed distally toward the root of the aorta.

[0066] Figure 18 The illustration shows the cutting of the natural leaflet at the base of the aortic root using a resection cutter.

[0067] Figure 19 The entire valve resection system is shown moving proximally to interlock the prosthetic valve across the edge left after the natural valve is removed.

[0068] Figure 20 The TAVI delivery system is shown entering the valvular resection system and its tip is positioned in the ventricle.

[0069] Figure 21 The distal portion of the TAVI is shown deployed directly beneath the temporary prosthetic valve.

[0070] Figure 22 The entire system, consisting of the resection system and the TAVI, is shown moving proximally into the aorta. The distal portion of the TAVI joins in the aortic root.

[0071] Figure 23 This demonstrates that TAVI is fully deployed and in place.

[0072] Figure 24 The resection valve system, which carries the contents of the removed natural valve leaflet, is shown being gradually compressed into a navigation catheter and then retrieved from the patient.

[0073] Figures 25 to 30 The procedure was described via the thigh.

[0074] Figures 31 to 36 The mixed transapical and transfemoral approaches are described.

[0075] Figures 37 to 42 This indicates a surgery performed solely via the transapical approach.

[0076] The reference numerals used in the attached figures

[0077] 1. Navigation catheter and its dilator 1'

[0078] 2. Anchored valve stents with proximal and distal structures.

[0079] 3. The structure of the stent supporting the prosthetic valve

[0080] 4. Prosthetic leaflet

[0081] 5. The fixing part of the anchoring valve stent's gripping system. Both the barbs gripping the ventricle (inside the natural leaflet) and the barbs gripping the fibrous membrane (outside the natural leaflet) are shown.

[0082] 6. Natural aortic valve leaflets. 6a is the fibrous membrane side, while 6b is the ventricular side.

[0083] 7. Barrels of the gripping system

[0084] 8. The rotating part of the gripping system that grasps the fibrous membrane side of the natural petals.

[0085] 9. Cutting cutter

[0086] 10. Cutting the support structure of the cutter

[0087] 11. Remove the blade from the cutter.

[0088] 12. Coronary arteries

[0089] 13. Aortic wall

[0090] 14. Catheter tip resection of the valvular system

[0091] 15. Braided catheter body of navigation catheter

[0092] 16. Distal handle with steering control via navigation duct

[0093] 17. The central handle of the control system supporting the resection system. This includes the advancement, deployment, and capture of the resection cutter and anchoring valve stent.

[0094] 18. Proximal handle for controlling a dedicated seamless transcatheter valve prosthesis

[0095] 19. Seamless transcatheter valve prosthesis delivery system

[0096] 20. Seamless transcatheter valve prosthesis Detailed Implementation

[0097] The valvular resection system consists of two devices designed to work coaxially and with different functions. The first internal one, 2, is called the "anchor valve stent," which provides temporary valve function 3, 4, while the natural leaflet 6 is blocked in the open position by barbs 7 placed in the middle part of the stent. Figure 1a , 1b 1c). The second external one is called the “cutting cutter” 9, which has a support structure with blades (usually 6 to 12 or more) at its end.

[0098] The anchoring valve stent 2 has a funnel shape with a total length of 70-80 mm. The proximal and distal portions have equal diameters and are larger than the intermediate portion (1 to 5 mm). The proximal portion is a stent-like structure designed to easily collapse into the navigation catheter 1. When deployed, the smaller intermediate portion must have a diameter 40-60% smaller than the aortic root as measured by CT scan imaging. It functions to block naturally stenotic leaflets 6 in the open position, holding them in place by grasping barbs 7, and, in general, maintaining aortic valve stability during resection. The grasping barbs 7 are designed to prevent leaflet embolism or fragmentation during resection.

[0099] The distal portion 3 of the anchored valve stent 2 is the valve stent itself. Its function is crucial because it maintains hemodynamic stability during surgery when the natural leaflets are locked in the open position. The prosthetic valve 4 is typically made of polymers (silicone, polyurethane and copolymers thereof, polymer-impregnated synthetic fabrics, biologically derived tissues such as bovine, porcine, or equine pericardial tissue, etc.) and is highly collapsible, providing temporary functionality. This distal portion of the anchored valve stent 2 is positioned below the aortic root. The temporary prosthetic valve 4 is typically trileafed, but can also be bileafed or unileafed. Valve assembly techniques above the distal portion 3 of the anchored valve stent 2 can vary, including liquid polymer impregnation, molding, suturing of polymer-impregnated fabrics, suturing of biological tissue, etc.

[0100] The natural aortic valve leaflet 6 has two distinct anatomical sides: the ventricle (the inner side of the valve facing the blood flow ejected from the ventricle) 6b and the fibrous membrane 6a facing the aortic wall. The gripping systems 5, 8 (see...) Figure 2 , 3a 3b) has several barbs 7, which are placed at regular intervals and may have different lengths, to grip the ventricular surface 6b. The gripping systems 5, 8 have a portion 8 provided with the barbs 7, which rotates 180° so that the barbs 7 can grip the fibrous membrane side of the leaflet 6a. As a result, the upper portion of the natural leaflet is locked at the level of its free edge.

[0101] The rotating part 8 preferably has at least three (one for each leaflet) arranged radially at 120°. The barbs 7 of the rotating part 8 may have different lengths, shapes and angles than those of the barbs of the gripping systems 5 and 8.

[0102] Figure 4 The resection cutter 9 has a support structure with struts 10, and a blade 11 is positioned distally thereat. This structure must be easily collapsible but sufficiently rigid upon deployment to provide precise cutting of the leaflet at the commissural level and leaflet base at the aortic root, leaving regular edges suitable for subsequent anchoring of a permanent sutureless prosthetic valve. Furthermore, the structure of the resection cutter 9 must be completely covered by a thin fabric clot, capable of capturing emboli (calcified fragments and / or blood clots) generated during the resection procedure, while simultaneously allowing blood flow through it. The blade 11 can have a variable number, typically 3 to 12, with varying lengths depending on the design. Resection procedure ( Figure 5The cutting motion is generated by the rotation of the resection cutter 9, which has relative rotational motion with respect to the anchored valve stent 2. The rotation and advance of the resection cutter 9 can be manual (direct or demultiplexed) or automatic (controlled by an electric micromotor, etc.). The diameter of the resection cutter is strictly adjusted by a predetermined diameter of the proximal portion of the anchored valve stent. In practice, a small and controlled gap is maintained between the two devices. The cutting diameter of the resection cutter must be within a well-controlled and stable dimension to avoid any damage to the aortic root or wall.

[0103] exist Figure 6 The cutting action of the resection cutter 9 is shown in the figure. During the resection of the naturally stenotic leaflet 6, the resection cutter 9 advances distally toward the aortic root, and the leaflet 6 is resected and held by the anchored valve stent 2.

[0104] exist Figure 7 In this procedure, after the natural valve is removed, the resection cutter 9 is removed via the navigation catheter 1. The anchoring valve stent 2 is then retracted proximally to allow the temporary prosthetic valves 3 and 4 to be engaged within the aortic root margin left after the natural valve resection. In an alternative embodiment, the resection cutter 9 and the anchoring valve stent 2 may be removed together within the navigation catheter 1 only at the end of the unilateral prosthetic valve implantation procedure to minimize any embolic spread.

[0105] It shows Figure 8 The complete valve resection system is described. The valve resection system is controlled by two handles 16 and 18, with the proximal handle 18 controlling the implanted sutureless prosthetic valve only at the end of the natural valve resection procedure. The system is provided with an external catheter 15 terminating at a tip 14, which allows the catheter 15 to enter the blood vessel at the access site. The distal handle 16 provides control of the resection cutter 9, while the intermediate handle 17 provides control of the anchoring valve stent 2.

[0106] The sequence of the excision surgery is described below.

[0107] The procedure is performed by puncturing the femoral artery, and after positioning the guide wire, a guidewire is inserted. It passes through the naturally narrowed aortic valve until it reaches the left ventricle. Figure 9 ).

[0108] A steerable navigation catheter 1 with dilator 1' is inserted above the guidewire through the femoral artery and navigates along the aortic arch to reach the naturally stenotic aortic valve. Figure 10 ).

[0109] Then the navigation catheter 1 is pushed through the natural valve ( Figure 11 ).

[0110] Remove the dilator 1' from the navigation catheter, allowing it to pass through the valve ( Figure 12 ).

[0111] The navigation catheter 1 is used like a hub to bring the necessary tools for the resection of the stenotic natural valve into place. Initially, the anchoring valve stent 2 is deployed above the natural leaflet 6 and placed through the natural valve.

[0112] The navigation catheter 1 is gradually retracted, and the anchoring valve stent 2 is exposed. Then, the distal portion of the anchoring valve stent 2, containing temporary polymer valves 3 and 4, is deployed. Figure 13 ).

[0113] Then deploy the central portion of the anchoring valve stent (2) and complete the further deployment of the proximal portion. Figure 14 ).

[0114] The anchoring valve stent 2 has a central portion (equipped with barbs 7 oriented on the outer surface, which have the function of retaining the valve leaflets on their ventricular side during resection, such as...) Figure 14 As shown in the diagram, the central portion is placed through the natural valve, its diameter is smaller than the natural valve itself, and the proximal and distal portions are slightly larger. Another set of barbs ( Figure 14 (Not shown) The leaflet is held on its fibrous membrane side. The distal portion of this anchored valve stent 2 is larger than the central portion and contains a polymer valve that supports the patient's hemodynamics as the natural valve gradually fails.

[0115] exist Figure 15 In the example shown, the anchored valve stent 2 has three rotating portions 8 preferably positioned at 120°, which hold the excised leaflet 6 on its fibrous membrane side.

[0116] Then the proximal portion of the anchoring valve stent 2 is fully deployed. Figure 16 ).

[0117] Through the same guiding catheter 1, the resection cutter 9 is inserted above the anchoring valve stent 2. Figure 17 ).

[0118] The resection cutter 9 is larger than the proximal and distal portions of the anchored valve stent 2. The resection cutter 9 is pushed forward above the anchoring device until it contacts the natural aortic valve and begins to resect the valve leaflets 6 until the valve is completely resected. Figure 18 ).

[0119] The resection cutter 9 is a self-expanding structure of controlled or predetermined size that opens to a diameter slightly larger than that of the anchored valve stent 2, and its cutting size is predefined by the operator. The resection cutter 9 has an external coating (thin-porous fabric material or continuous polymer membrane) designed to prevent debris from embolizing towards the coronary ostium, and a cutting mechanism 11 (e.g., up to 12 blades) is located at its distal end. The aim is to provide a clean cutting surface of precise diameter within the aortic root to locate a dedicated, seamless prosthetic valve. To prevent material embolism, the resected leaflet 6 is held within the gap between the anchored valve stent structures 5 and 8 due to the externally located barbs 7 and the resection cutter 9. Figure 18 ).

[0120] The two devices are then slightly retracted into the ascending aorta, and temporary valves 3 and 4, present in the distal portion of the anchoring valve stent 2, are fitted within the edge of the aortic root to maintain the patient's hemodynamic stability. Figure 19 ).

[0121] exist Figure 20 The image shows a seamless transcatheter valve delivery catheter 19 inserted through a resection valve system.

[0122] A specially designed transcatheter valve prosthesis 20, collapsed into its delivery system 19, is inserted via a guide catheter 1 and an anchoring valve stent 2 is inserted internally. It passes through the anchoring valve stent 2 and its distal valve portions 3 and 4 and is positioned within the left ventricle. Figure 20 ).

[0123] The seamless transcatheter valve prosthesis 20 was initially deployed distal to temporary valves 3 and 4. Figure 21 ).

[0124] Simultaneously, the entire resection system 2 and 9 gradually retracts into the ascending aorta, and the unilateral transcatheter valve prosthesis 20 is gradually deployed into the aortic root. Figure 22 , 23 ).

[0125] Then the delivery system for the seamless transcatheter valve prosthesis 20 was completely retrieved. Figure 23 ).

[0126] As a final step, the excision cutter 9 and the anchoring valve stent 2 containing the excised leaflet 6 gradually collapse into the guiding catheter 1 and are retrieved from the patient, thereby leaving the new seamless transcatheter valve prosthesis 20 in place. Figure 24 ).

[0127] exist Figures 25 to 30In another example described, the final seamless transcatheter valve prosthesis 20 can also be used as a temporary valve in place of the valve portion 3 of the anchor valve stent 2. A mandatory condition is that the seamless transcatheter valve prosthesis 20 is designed to be completely recaptured within its delivery catheter 19.

[0128] In this case, the guiding catheter 1 is initially positioned in the ascending aorta, directly above the natural aortic valve. The delivery catheter 19 advances above the guidewire and passes through the natural valve 6. Then, a unibody transcatheter valve prosthesis 20 is partially deployed below the natural aortic valve 6, the delivery catheter 19 is retracted, and it is given valvular function as a temporary valve. At this stage, the entire resection system 2, 9 advances. In this case, the resection system consists only of the anchored valve stent 2, without the distal valve portions 3, 4. The natural valve 6 is grasped and resected as follows... Figure 2-7 The procedure is performed as described above. When the resection of the natural valve 6 is complete, the resection systems 2 and 9 are gradually retracted into the ascending aorta above the sinus-duct junction, leaving sufficient space for the deployment of the unilateral transcatheter valve prosthesis 20. At this stage, the unilateral transcatheter valve prosthesis 20 partially collapses into its delivery catheter 19, repositions itself above the edge left by the resection of the natural valve 6 in the aortic root, and is redeployed in place as the established prosthetic valve. At this stage, the delivery catheter 19 is completely retracted from the patient using its handle 18. The procedure is then completed by collapsing the resection cutter 9 and the anchoring valve stent 2 containing the resected leaflet 6 into the guiding catheter 1. The handle 17 controlling the resection systems 2 and 9 is then removed from the patient. As a final action, the navigation catheters 1 and 15 are retracted from the patient using their handle 16.

[0129] In another example ( Figures 31 to 36 In this procedure, the same procedure can be performed via a transapical approach. A transapical access is achieved by placing a pursue string at a predetermined position on the apex of the ventricle using a CT scan, allowing access to the natural aortic valve via puncture of the left ventricle. This access allows direct orthogonal entry into the aortic valve. A navigation catheter 1 is introduced transapically and passes through the natural aortic valve. An inverted temporary prosthetic valve is deployed in the ascending aorta (to prevent aortic valve backflow). The resection valve system 2, 9 is then deployed, and the natural valve 6 is removed using resection cutters 9, 10, 11 following the same procedure described above. The final seamless transcatheter prosthetic valve 20 is then implanted via a transfemoral access.

[0130] In another example ( Figures 37 to 42In this procedure, the resection of the natural aortic valve 6 can be fully performed via a transapical approach using a final seamless transcatheter prosthetic valve 20, which also serves as a temporary valve support. The seamless transcatheter prosthetic valve 20 is partially deployed at the level of the mitral-aortic continuum below the natural aortic valve 6. The grasping systems 5 and 8, in a closed configuration, advance through and deploy the seamless transcatheter prosthetic valve 20. With the natural valve leaflet 6 locked, a resection cutter in a closed configuration is inserted through the seamless transcatheter prosthetic valve 20 and positioned above the grasping systems 2, 5, and 8. After complete resection of the natural valve 6, the entire system, including the seamless transcatheter prosthetic valve 20, is pushed toward the aorta and head to deploy the seamless valve 20 in place. Once the seamless transcatheter prosthetic valve 20 is fully deployed, the resection valve systems 2 and 9 then gradually close and retract from the heart through the seamless valve 20.

Claims

1. A transcatheter resection device for a natural or biological prosthetic heart valve (6), the transcatheter resection device comprising a leaflet grasping system (5, 8) and a leaflet cutting device (9), the grasping system (5, 8) and the cutting device (9) being coaxial and longitudinally movable relative to each other, wherein, The gripping system (5, 8) is longitudinally oriented, characterized in that the gripping system (5, 8) includes a fixed part (5) and a rotating part (8); the fixed part (5) is adapted to grip the leaflet surface (6b), and the rotating part (8) is adapted to grip the opposite leaflet surface (6a). The gripping system (5, 8) is located inside the cutting device (9), and the valve to be removed is inside the cutting device and outside the gripping system.

2. The apparatus according to claim 1, wherein, The gripping system (5, 8) includes barbs (7) that are oriented proximally when they interact with the leaflets (6).

3. The device according to claim 1 or 2, comprising an anchored valve stent (2), the anchored valve stent having a distal portion (3, 4) providing temporary valve function and a proximal portion including the gripping system (5, 8).

4. The apparatus according to claim 3, wherein, The anchoring valve stent (2) has a funnel shape, and the gripping system (5, 8) is located within the narrow portion of the anchoring valve stent (2).

Images