阅读说明：本技术 用于血管的经导管瓣膜假体 (Transcatheter valve prosthesis for blood vessels ) 是由 E·帕斯奎诺 F·博内蒂 F·奥斯塔 S·奥斯塔 于 2018-04-23 设计创作，主要内容包括：一种用于血管的经导管临时瓣膜假体,该经导管临时瓣膜假体包括可扩张支撑结构(5”)、瓣膜(7)、过滤器(12)以及输送器(6)；所述支撑结构(5”)在扩张时形成管状形状,具有远端和近端,所述瓣膜(7)位于所述远端处,并且所述输送器(6)从所述近端向所述远端在所述支撑结构(5)内延伸,并且包括适于充当用于其他装置的引入器的中心通道。(A transcatheter temporary valve prosthesis for a blood vessel, the transcatheter temporary valve prosthesis comprising an expandable support structure (5 "), a valve (7), a filter (12), and a conveyor (6); the support structure (5 ") forms a tubular shape when expanded, having a distal end at which the valve (7) is located and a proximal end, and the transporter (6) extends within the support structure (5) from the proximal end to the distal end, and comprises a central channel adapted to act as an introducer for other devices.)

1. A transcatheter temporary valve prosthesis for a blood vessel, the transcatheter temporary valve prosthesis comprising an expandable support structure (5 "), a valve (7), a filter (12), and a conveyor (6); the support structure (5 ") forms a tubular shape when expanded, having a distal end at which the valve (7) is located and a proximal end, and the transporter (6) extends within the support structure (5) from the proximal end to the distal end, and comprises a central channel adapted to act as an introducer for other devices.

2. The prosthesis according to claim 1, wherein the filter (12) and the conveyor (6) are combined in such a way as to form a single element.

3. The prosthesis according to claim 1, wherein the filter (12) is positioned against an inner wall of the support structure (5).

4. The prosthesis of any one of the preceding claims, wherein the carrier comprises a funnel portion on the proximal end and a tubular portion on the distal end.

5. The prosthesis of claim 4, wherein: the distal end of the conveyor (6) comprises a two-way normally closed valve that can be passed through as required to act as a leak-free introducer for other devices (6 ").

6. Prosthesis according to any of the previous claims, wherein the valve (7) comprises several leaflets.

7. Prosthesis according to any of the preceding claims, adapted to be deployed and positioned in an anatomical operation site, having the function of supporting the blood circulation in case of acute significant valve insufficiency.

8. The prosthesis according to claim 7, adapted to have the function of supporting blood circulation in case of acute pronounced aortic valve insufficiency.

9. The prosthesis according to claim 8, comprising a periaortic vessel deflector (9) adapted to be placed along the periaortic vessels, which prevents embolisation of debris into them.

10. Prosthesis according to claim 8 or 9, comprising two coronary deflectors (8) adapted to be placed in front of the coronary ostia, preventing debris emboli into the coronary arteries.

11. Prosthesis according to any of the previous claims, wherein said valve (7), said filter (12) and said conveyor (6) are located inside said supporting structure (5 ").

12. Prosthesis according to any of the previous claims, wherein the support structure (5 ") has a tapered end comprising a plurality of captive struts (4 ', 4") adapted to engage an internal conduit (3 '), wherein the structure is collapsible from an expanded state to a compressed state by pulling on the captive struts (4 ', 4 ").

Technical Field

The present invention relates to expandable prosthetic valves designed to be positioned within a vessel during repair or replacement of a native valve, such as an aortic valve.

Background

The clinical complications associated with transcatheter heart valve prosthesis (TAVI) implantation are mainly related to the fact that it overlaps with the diseased native valve. The severe presence of tissue calcification involving the valve device and surrounding tissue affects the proper deployment of the prosthesis, which allows for the onset of embolism.

Thus, the different types of clinical complications associated with TAVI implantation are mainly related to dystrophic calcification of the native valve and heterogeneous deployment of the valvular prosthesis, and are:

moderate to severe perivalvular leaks (grade II)

Occurrence of embolic events (blood clots and fibers or calcified emboli)

The incidence of moderate to severe perivalvular leakage (PVL) after transcatheter aortic valve prosthesis implantation was at least 10%, with mortality peaks around one year for this particular subgroup of patients.

For PVL, the clinical data applicable to the second generation transcatheter heart valves is vastly superior to the first generation clinical data. In fact, the incidence of moderate PVL dropped to 3.4%, but different authors recorded a higher percentage of PVL complications in patients with "high calcium scoring valves".

Coronary occlusion is a clinical complication arising from two different causes, namely mechanical occlusion of the coronary ostia caused by native leaflets of the aortic valve or embolization of calcium debris during TAVI implantation surgery. Although the incidence of this clinical complication is only 1% of TAVI implantation, it is fatal in 50% of cases even with a delay of several days after implantation surgery. The spread of TAVI implantation to intermediate risk patients further increases the severity of events to a younger patient population.

Mechanical occlusion of the coronary ostia may occur because TAVI pushes calcified native leaflets outward during its deployment, which creates an occlusion of the coronary ostia. The same may occur when TAVT is implanted on a degenerated bioprosthesis. Particularly with respect to certain bioprostheses, such as "stentless" bioprostheses, risky coronary ostia occlusion is more frequent when TAVI is implanted.

Surgical embolic events (so-called "macroembolic brain events") occur during TAVI implantation surgery (before, after or after dilation) and are mainly associated with the embolization of macroscopic fragments of calcium that are usually targeted to fibroelastic particles of the brain (stroke), coronary arteries or surrounding organs. However, stroke is the most feared clinical event, with a 2.7% incidence present and a 3.3% incidence of TAVI of the previous generation. The reduction in stroke is associated with a smaller need before and after dilation during TAVI implantation, but the data is unclear as it relates to aortic valves that are slightly calcified.

Post-operative microembolism brain events were recorded in at least 8% of patients under investigation. The high incidence of new brain injury following TAVI requires long-term assessment of neurocognitive function.

In this study, performed during a short follow-up period of 3 months, no neurocognitive function impairment was clinically observed, and most of the impairment (80%) had resolved on the 3-month MRI. However, once the indication of TAVI expands to include younger patients with long life expectancy, perioperative cerebral embolism problems and their potential impact on neurocognitive function may be predictive of greater clinical significance. Thus, future research in the TAVI field should be devoted to developing strategies to reduce the risk of embolism (e.g. less trauma, smaller-bore catheter systems, improved identification of patients at risk of embolism and possible use of brain protection devices).

In some clinical studies, at least 10% of patients receiving TAVI implants showed detectable nerve damage during cardiac intellectual testing. While this incidence is acceptable in high risk and elderly patients, it does not appear to be acceptable in younger patients at lower risk. Several clinical studies are being conducted to better investigate this clinical situation.

Another embolic event is sub-acute and chronic microembolic events that occur immediately after surgery. The native aortic calcified valve is rough with a warty surface that behaves like an atherosclerotic ulcer plaque after fixation. This condition favors the formation of microthrombosis, which later cause embolisms towards the brain and other surrounding organs. Native aortic valves left in place as a source of microemboli are considered in several clinical studies that suggest their role in the onset of angiogenic dementia. This evidence is alarming when TAVI is implanted in younger patients, in which case acceleration of vascular dementia may severely impact social costs.

In summary, perioperative clinical complications following TAVI implantation are strongly associated with the presence of heavily calcified aortic valves left in situ. Acutely, it causes macroembolic brain events (stroke) and the occurrence of hemodynamic consequences (e.g. PVL), which lead to various severe aortic insufficiency. These unsatisfactory clinical results are closely related to the irregular deployment of transcatheter valve prostheses with highly calcified native aortic valves.

A longer-term clinical complication is characterized by cerebral microembolism, which results from the leaflets of the aortic valve remaining in place, which are the source of emboli leading to vascular dementia.

The total clinical complication rate for TAVI is between 5% and 12%. This incidence is likely to be underestimated because it does not include patients with highly calcified and mitral native valves.

These evidence highlights the importance of protecting the surrounding organs (especially the brain and heart) from emboli that occur during TTWI surgery.

Today, there are several devices on the market that protect organs from embolic products, acting as deflectors or anti-embolic filters. In the case of the deflector, the protection system deflects the emboli from the brachiocephalic trunk and left common carotid artery towards the peripheral circulation. In the case of anti-emboli filters, they actually trap emboli with a net.

International patent application WO 2015/185870 discloses a temporary valve prosthesis designed to be inserted into the aortic root at the sinotubular junction.

The device includes a filter housed within a valve having a conical shape.

The above-referenced arrangement provides some improvements over other prior art arrangements. However, it presents some inconveniences, such as the risk of leakage caused by blood reflux or by difficulties in inserting additional devices through the prosthesis due to catheter size limitations.

Disclosure of Invention

The inconveniences discussed in the previous sections are solved by means of the present invention, which relates to a device as defined in the claims.

More specifically, the present invention includes an integrated system that simultaneously provides anti-emboli protection, valve function, and a self-centering transporter for other devices. The transporter function is adapted to enter and center a transcatheter device (a device for reducing native leaflet stiffness or partial/complete ablation of a native valve) or TAVI or other valve to be implanted operating on a diseased native valve. Thus, the system may optimize the entire TAVI procedure and may be very effective in reducing acute perioperative clinical complications that may occur, particularly in complex procedures.

The device according to the invention is conceived to be completely collapsed inside a catheter and introduced into the artery of a patient, intended to reach the aortic arch and to be deployed in position. The device allows for the passage of a different transcatheter device than that used to perform surgery on the native valve, while providing temporary valve support and protecting the heart, brain, and surrounding organs from any kind of embolism.

The device may be fully or partially collapsed for repositioning during surgery. At the end of the procedure, the device is collapsed, retracted within the shaft and completely removed from the patient.

The device preferably has a valve prosthesis housed within a shaped support structure that is leak-free coupled to the aortic wall. The second structure, either internal or distal with respect to the support structure, acts as an anti-embolus filter. A third structure, referred to as a delivery device, having a tapered or funnel-like shape, may be internal or distal with respect to the support structure and pass through the inner lumen of the valve prosthesis. It has the function of creating a catheter across the device and facilitating the introduction of several transcatheter devices operating on the diseased aortic valve and the relative alignment with respect to the valve axis.

In one embodiment, the valve prosthesis is anchored to an inner surface of the support structure. In this case, the expansion of the outer support structure in contact with the aortic wall is accommodated by the inner valve prosthesis. Therefore, the device must be accurately dimensioned at the time of intervention in order to avoid prosthetic valve insufficiency with limited efficacy in terms of hemodynamic performance and anti-embolic protection.

In another set of embodiments, the valve prosthesis can be considered independent of the embolic filter, so that the expansion of the latter fits to the aortic wall without interfering with the function of the valve prosthesis. This embodiment requires that the external support structure and the internal valve prosthesis are connected by some sort of septum. Thus, the size of the inner valve prosthesis, when fitted to the aortic wall, varies independently of the diameter of the outer support structure. Several embodiments belong to this group, differing in the positioning of the filter and the conveyor element and in the material of the support structure, i.e. embodiments with the conveyor and/or the filter inside or outside the main support structure and embodiments in which all support structures are made of self-expanding metallic material or expandable structures or a mixture thereof.

Detailed description of the invention

The invention will be better understood in relation to some illustrative examples.

Reference numerals used in the drawings

1 guide wire

2 balloon catheter tip

3 external shaft catheter of device

Internal shaft catheter for 3' device

4 device

4 'captive strut connecting the device to inner core catheter 3'

4 "captive strut connecting carrier 6 and valve support stent 14

5 external support structure of device

5' anchoring holes to the filter screen

5 "Combined internal Structure (comprising elements 6 and 14)

5' "captive strut having a locking hole connecting the structure 5" (valve support stent 14 and transporter 6 combined as a single element) with the external support structure 5

6 conveyor (integrated in 4 or external)

Inner lumen of 6' conveyor

6' distal conveyor tube with two-way normally closed valve

6 "' anchoring hole for a conveyor placed outside the device 4

7 leaflet of an endoprosthesis

8 coronary artery deflector

9 periaortic (endovascular) vessel deflector

10 nets mounted on the inner or outer surface of the support structure 5, coupled with the inner surface of the aorta, having an anti-embolus filtering function

11 to the inner shaft guide 3' (connection ring)

11' connecting ring, which connects the device with the external conveyor 6

12 anti-bolt filter screen, normally mounted on the conveyor 6

13 connecting diaphragm between external support structure and internal valve prosthesis structure 12

14 valve support stent

14' leaflet anchoring structure

14 connecting strut between mooring stay 4 and valve support

15 prosthetic valve

16 an inflatable structure

17 mechanism for forcing the leaflets 7 open

18 radiopaque marker

Drawings

FIG. 1: a device 4 enclosed inside the shaft 3 and positioned in the aorta at the level of the sinotubular junction.

FIG. 2: a device 4 with an open prosthetic valve deployed in the ascending aorta.

FIG. 3: a device 4 with a closed prosthetic valve deployed in the ascending aorta.

FIG. 3 a: the device 4, as shown in fig. 3, deployed in the ascending aorta, shows the direction of blood flow.

FIG. 4: a device 4 with a coronary deflector 8 and a periaortic vascular deflector 9 deployed in the ascending aorta.

FIG. 4 a: the device 4, as shown in fig. 4, deployed in the ascending aorta, shows the direction of blood flow. The deflector prevents emboli but does not impede blood perfusion.

FIG. 5: the mixing device 4 in the deployed configuration (long axis view).

FIG. 6: the mixing device 4 in the deployed configuration (short axis view or compartmental view).

FIG. 7: a support stent 14 for the internal valve.

FIG. 7 a: support stent 14 for internal valve: one configuration of the inflow profile.

FIG. 7 b: support stent 14 for internal valve: alternative configurations of the inflow profile.

FIG. 7 c: support stent 14 for internal valve: alternative configurations of the inflow profile.

FIG. 7 d: support stent 14 for internal valve: alternative configurations of the inflow profile.

FIG. 7 e: support stent 14 for internal valve: alternative configurations of the inflow profile.

FIG. 8: an outer support structure 5.

FIG. 9: an outer support structure 5 and a support stent 14 for the valve.

FIG. 9 a: an outer support structure 5 and a combined inner structure 5 ".

FIG. 9 b: the combined internal structure 5 "of the integrated transporter 6 and valve support stent 14. The structure 5 "is anchored to the external support structure 5 by means of keyhole tie down struts 5".

FIG. 10 a: the internal structure of the device 4, showing the interaction of the transporter and the prosthetic valve 15.

FIG. 10 b: different views of fig. 10.

FIG. 11: device 4 without the anti-embolus filter screen 10 assembled.

FIG. 12: a device 4 assembled with a self-expanding mesh.

FIG. 13: as shown in fig. 12, an apparatus having only a conveyor.

FIG. 14: the device shown in fig. 12 has an outer support structure and an inner valve anchored to its inner wall.

FIG. 15: the device shown in fig. 12 is shown with only the external support structure.

FIG. 16: a device 4, wherein the conveyor system is placed outside the device. In this embodiment, it has been placed serially in series at the proximal end of the device.

FIG. 16 a: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 16 b: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 16 c: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 16 d: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 16 e: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 16 f: another embodiment of the apparatus 4, wherein the conveyor system is placed outside the apparatus.

FIG. 17: the device 4 shown in fig. 16, but without the tube with the two-way normally closed valve 6 "and the distal delivery of the valve support stent 14.

FIG. 18: an internal valve support stent 14 and a distal transporter tube with a two-way normally closed valve 6 ".

FIG. 19: a device 4 having an expandable structure supporting the device. The transporter is placed at the proximal end of the device 4 as shown in fig. 16.

FIG. 20: the device 4 as described in figure 19. The internal structure is visible. The support stent 14 of the valve is visible.

Detailed Description

Surgery

In this section, the procedure is described by means of an item description relating to an embodiment with a valve, a filter and a transporter element inside an external support structure (see fig. 5). It is contemplated that the procedure is also applicable to other embodiments having different items positioned relative to each other.

The device is collapsed into an external shaft catheter 3 (fig. 1) prior to its introduction into the arterial vessel. The distal portion of the outer shaft catheter is fitted with a balloon catheter tip 2 that is deployed across the edge of the outer shaft catheter 3. The function of this balloon tip is to avoid any arterial wall damage during the travel of the device towards the ascending aorta while ensuring accurate positioning, when inflated with a radiopaque solution. When the device is positioned at the level of the sinotubular junction, the balloon tip is deflated and retracted outside the patient. In fig. 2, the device is deployed inside the ascending aorta, retracting the outer shaft catheter 3. When the device is deployed, the outer support structure 5 fits into the aortic wall in order to deliver all blood into the device. The device 4 is connected to the inner shaft conduit 3 'by means of struts or tethers 4'. Internally, the device has two parts held by an external support structure 5: a delivery device 6 and a valve prosthesis 15. The conveyor 6 is fixed proximally to the proximal portion of the outer support 5 and defines a "funnel-shaped" channel 6' inside the device. The transporter functions to allow the device (annuloplasty balloon or TAVI, etc.) to traverse towards the aortic valve. For the particular embodiment described, another function of the carrier 6 is to support the anti-embolus filter. The role of prosthetic valves equipped with two, three, or more leaflets is to avoid substantial backflow of blood flow during interventional procedures performed on the native aortic valve (e.g., significant paravalvular leakage following valvuloplasty of the aortic valve, post-TAVI implantation, or future interventional ablations). The prosthetic valve 15 may be anchored directly to the distal edge of the outer support structure 5, but in the described embodiment it is mounted on a separate valve support and is joined to the outer support structure 5 by a fabric membrane. Valve function is imparted by the engagement of the leaflets which, in the closed stage, adhere to the distal outer surface of the transporter 6. Fig. 2 and 2a show the device 4 and diseased valve in the closed and open positions, respectively.

In fig. 3, the device is shown deployed as shown in fig. 2, but the device is equipped with additional features, represented by two coronary filters 8 and one periaortic vascular filter 9. The two coronary filters prevent possible debris embolization into the coronary ostia during the interventional procedure on the aortic valve. Although not very often, this event is often catastrophic. The purpose of the periaortic vascular filter is to avoid possible residual debris that is accidentally not fully captured by the device 4, towards cerebral embolism, which causes a stroke. In the case of high risk surgery, the deflector may be deployed by further retracting the outer shaft catheter 3.

The coronary and periaortic vascular protection systems mentioned above may be applied in virtually any of the embodiments described below.

During function, blood flow in systole passes through the native aortic valve, opening the valve prosthesis and passing through the anti-thrombus filter 6. Fig. 4 details the direction of blood flow during systole, the predominant flow pattern through the aorta, along with the flow pattern through the periaortic vessels and the flow through the coronary arteries, which are imparted by the incomplete sealing of the coronary ostia by the native valve.

Embolic debris is captured and retained within the structure between the carrier 6 and the outer support structure 5.

If desired, the device may be left in place for a period of time to allow stabilization of the patient's hemodynamics and then removed. In this case, a special mechanism can be used that forces the prosthetic valve open to verify the restoration of native valve function at the time of treatment, and to repeat the treatment if necessary. The valve opening mechanism mentioned above can be applied in virtually any of the embodiments described below.

At the end of the procedure, the device operating on the native aortic valve is removed from the inner lumen of the transporter 6'. The device 4 is fully retracted by pushing the outer shaft catheter 3 distally. In this way, the device structure gradually collapses until the distal end of the device is reached, which safely retains all captured blood clots or calcium debris inside the device.

The device 4 is conceived to provide an effective anti-embolic protection during an interventional procedure on the native aortic valve and to support the blood circulation in the presence of aortic valve insufficiency.

In particular, mild to severe valvular insufficiency of the native valve may occur after balloon valvuloplasty, suboptimal TAVI implantation, or TAVI misimplantation with subsequent migration. This last condition can be clinically catastrophic, with limited likelihood of patient survival.

In another future situation, the device is absolutely necessary. This is the case with interventional non-extracorporeal surgery to remove the diseased native aortic valve. In this complex procedure during dissection (dissection) of the native valve, anti-embolic protection is mandatory, and more importantly, there is a need to assist aortic valve function while implanting a suture-free valve prosthesis. The device can meet all these requirements.

In certain embodiments, a valve that integrates a embolic filter and a valve prosthesis in a single device may provide two separable components.

In the case of interventional ablation of a diseased aortic valve after its removal, the prosthetic valve can be detached from the device 4 and left in place as a permanent suture-free valve prosthesis, similar to a TAVI procedure.

Description of the main elements of the device

Valve prosthesis

The valve allows for temporary replacement of a diseased valve during surgery while allowing the hydrodynamic performance to be compatible with the clinical condition of patients with aortic stenosis.

Support structure

The support structure may be a single element structure 5 "or a multiple element structure. In the first case, it has the function of coupling with the aorta, supporting the valve and the filter and acting as a conveyor. In the second case, the external support 5 has the function of coupling with the aorta and of supporting other structures. The support stent 14 of the valve is intended to support the leaflets; the conveyor support 6 is described below. The inner surface of the support 5(5 ") is covered by a network of anti-embolus tissue 12 to allow the device to better seal against the aortic wall, but also to prevent emboli migration with limited contact.

Filter

The filter 12 allows retention of embolic debris without significantly altering the hydrodynamic properties of the valve. In some embodiments, the filter and conveyor fabrics are joined as a single element.

Conveyor

The conveyor 6 is an introducer element of TVAF: due to the geometry of its components, it makes it easier to locate a particular device (i.e., TAVI) equipped with an external catheter 3 in situ. Typically, a series of elements are interconnected: a tapered support structure with an anti-embolus mesh liner (e.g., fabric or membrane), a distal cylindrical expandable tubular portion with an impermeable liner, and a two-way normally closed valve.

In some embodiments, the transporter 6 and the valve support stent are joined as a single element 5 ".

Inner and outer shaft conduits

The inner shaft conduit 3' permanently supports the device 4 in a default setting. The inner shaft catheter is protected by an outer shaft catheter 3, which outer shaft catheter 3 has the function of guiding the device into place and allowing deployment/recapture of the device 4.

Of course, the present invention is not limited to the embodiments and examples discussed in this document. Thus, the present disclosure should not be limited by any particular elements described below.

More details in terms of materials: for most embodiments, the support structure is described herein as being made of a self-expanding metallic material (e.g., nitinol), but other metallic and non-metallic materials having similar properties may be employed, and non-self-expanding structures, such as polymeric expandable structures, may also be employed; the filter is described as a polymeric woven fabric, but non-woven fabrics (i.e. membranes with calibrated pores) and/or metallic materials with similar properties may also be applied; the valve is described as a polymeric woven fabric coated to ensure leak-free properties, but non-woven fabrics with similar properties may also be applied; the catheter comprises a polymeric tube and further comprises a metal reinforced polymeric tube.

In terms of technology: metallic support structures are described as being obtained from laser-cut tubes or welded plates, from braided (i.e. from multi-strand) and single-wire structures; the coupling between the different elements of the device may be gluing, soldering, welding (i.e. ultrasound), gluing, stitching, and other suitable methods; the valve may be obtained by coating a fabric, but other synthetic or natural materials, such as polymeric films, may also be applied.

With respect to the embodiment: in the description, embodiments are shown which are considered for use in connection with femoral access for restoration of a diseased aortic valve. Also, embodiments with different entry than strands may be applied. For use as a TAVI or suture-free valve prosthesis, specific embodiments may be employed in which the valve portion may be detached by the remainder of the assembly. In this case, the leaflets of the valve may be made of a different material than the polymeric leaflets, such as pericardial tissue or other materials, and the valve structure may also have specific retrieval elements.

Moreover, embodiments for restoring other diseased heart valves may also be applied.

The device may also find application in other fields of technology, such as interventional radiology, as valved or valveless filters for carotid artery protection and repositionable/recapturable venous valves with anti-embolic filters. In this case, the specific embodiment and dimensions of the different elements to be used in the default settings (valves, filters, transporters and associated support structures, catheters) and the intended use (acute, subacute, chronic) will apply.

In terms of dimensions, dimensions relevant for the specific use will be applied, such as the dimensions of the anatomy of the healthy and diseased organ to be treated, the dimensions of the channels for the different transcatheter accesses, the dimensions of the filter against embolisms in the coronary arteries and periaortic arteries.

Fig. 5-11 illustrate one embodiment, hereinafter referred to as a hybrid device, which is a technique for fabricating a laser cut outer support structure 5 and a valve support stent 14 and a braided or wired self-expanding nitinol structure for the transporter 6.

In this embodiment, the outer support structure 5 and the support stent 14 of the inner valve are connected by some sort of membrane 13, thereby ensuring independent deployment of the inner prosthetic valve 15 with respect to the outer support 5 and the embolic filtering element. A conveyor 6, which also acts as a filter support, is positioned inside the outer structure 5, in order to reduce the length of the entire device.

In fig. 5, the long-axis view of the device in the deployed configuration shows the ring permanently joining the inner shaft catheter 3 'to the outer self-expanding support structure 5 and the carrier 6 and valve support stent 14 by means of the captive struts 4' and 4 ". In fig. 5, the coupling between the outer support structure 5 and the inner mesh liner 10 is also shown, which ensures leak-free contact to the aortic wall.

In fig. 6, a short axis (compartmental) view of the device 4 in the deployed configuration shows the anchoring holes between the outer structure 5 and the mesh 10, which is restored distally and coaptates to the leaflets 7 of the valvular prosthesis 15, which cover the outside of the support stent 14 of the valve inside the self-expanding material. The non-permeable net of the leaflet members 7 and the net 10 together with the configuration of the conveyor conduit equipped with the two-way normally closed valve 6 "at the distal end ensure a leak-free diastolic phase. The valve 6 "remains closed both in systole and in diastole, in order to prevent any leakage of blood and possible embolic particles; when the transcatheter device is introduced, the tube 6 "of the distal transporter extends in diameter, which facilitates its introduction, maintaining proper alignment, while the valve 6" allows almost leak-free passage of the device. The valve 6 "may be operated directly by the delivery system or automatically, remaining tightly closed at the systolic and diastolic pressure differences, but capable of being passed through by the inserted device delivery system while maintaining a leak-free coupling.

Fig. 7 shows a support stent 14 of a self-expanding internal valve, which supports the commissures of the leaflets 7 and the overall inflow profile of said leaflets 7 by means of specific connecting pieces (joins) 14', which draw the profile of the structure from the outside. This configuration allows minimizing systolic pressure drop due to wide and cylindrical leaflet openings and minimizing closing and leakage regurgitant flow during diastole. The captive stay 4 "allows direct engagement with the inner shaft conduit 3' with sufficient independence from the outer support 5.

Fig. 7a, 7b, 7c, 7d and 7e show alternative configurations of inflow profiles for ensuring sufficient retrievability and radial stiffness at the same time.

Fig. 8 shows a self-expanding outer support structure 5 supporting the conveyor 6 and the associated filter mesh 12 at the side of the anchoring hole 5' and the coupling of the mesh 10 to the inflow side of the leaflet 7.

In fig. 9, both the outer and inner self-expanding structures 5, 14 are shown, without the associated netting, to summarize the mutual positioning of the tethering structures that join them to the inner catheter 3' together with the apertures for connecting to the transporter 6 and leaflet 7 elements.

As illustrated in fig. 9a and 9b, the inner elements of the stent support 14, referred to as transporter 6 and valve, may be combined into a single element 5 "to be engaged to the outer structure 5 by a captive strut with a keyhole 5"'.

In fig. 10, the outflow side of the carrier 6 supporting the filter 12 and the elements of the prosthetic valve 15 are shown, together with the self-expanding internal valve support stent 14 and the tie-down struts connecting the structure to the internal shaft catheter 3'.

In the case of the conveyor and the filtering element, the conical shape of the conveyor firstly ensures that the device equipped with an external duct different from the external duct 3 passes smoothly and easily; secondly, it is covered by a filter 12 with a suitable mesh and surface in order to minimize the associated pressure drop during the systole and to filter any possible embolic debris originating from the operation and to keep it in the collection chamber obtained between the meshes 12 and 10; third, it ensures smooth retrieval. The distal end of the delivery device is cylindrical with the axis aligned with the diseased valve to be treated to ensure proper alignment of the device. Furthermore, the cylindrical portion has a radial compliance sufficient to minimize the force applied to load and retrieve the device via the delivery system.

In fig. 10a, the same elements are seen from the inflow side (compartmental view), showing a two-way normally closed valve at the distal portion of the transporter, which valve ensures no flow during systole to prevent any emboli from passing through the device 4, and no flow during diastole to minimize overall leakage, while allowing the device to be installed to pass through the device 4.

In terms of a valve, fig. 10 and 10a show the prosthetic valve body 15 from the outflow side and inflow side. A tri-leaflet configuration was chosen, with the leaflets made of a low thickness polymeric fabric, the fibers being elastomer coated and mounted on the exterior of the support structure 14 to ensure a wide leaflet cylindrical open configuration. This design configuration ensures optimal flexibility/foldability and lower extensibility of the same type, thereby ensuring optimal hemodynamic and mechanical properties. The design and materials allow sufficient hemodynamic performance with respect to low pressure drop during systole due to the large orifice area and leaflet foldability, and allow adequate hemodynamic performance with respect to low regurgitation during diastole due to the non-leaking nature of the leaflets and associated foldability which allows proper coupling of the closure of the leaflets with respect to the distal transporter non-leaking tubular body 6 ".

Fig. 11 shows the configuration of the device 4 assembled without the mesh 10, in order to visualize the mutual positioning of the transporter/filter and the valve with respect to the relative external support structure 5 and the support structure of the support stent 14 of the valve.

Radiopaque markers are placed to better detect specific locations (e.g., posts and lateral passageways) as well as internal catheter locations (e.g., aortic arch level). The materials, engagement structures, and number of elements are selected based on the prior art and based on the current procedure.

Fig. 12-15 show an alternative embodiment configured as a hybrid embodiment with the conveyor inside the body in order to minimize the overall length, but with both the outer support structure 5 and the conveyor 6 made of superelastic metal mesh, hence the so-called mesh embodiment. Another difference from the hybrid embodiment is that in the mesh embodiment, the outer support structure 5 provides an anchoring surface directly to the leaflets of the prosthetic valve 15.

Fig. 12 shows a side view of a mesh assembly with the outer cylindrical structure 5 and the relative couplings between the mesh 10, the transporter 6 and the associated mesh 12, the prosthetic valve 15, and the elements.

The coupling elements of the superelastic metal outer structure 5 are as follows: a captive structure 4 'permanently joined to the inner conduit 3' by means of a ring 11, keeping the inflow side of the outer structure 5 and the carrier 6, while allowing the elements to slide over each other to allow proper self-expansion and retrieval; a cylindrical tube mesh 10, which acts as an interconnecting element between the outer structure 5 and the prosthetic valve 15, i.e. to the valve by means of sewing/ultrasonic welding them to the tube 10 on the inflow and outflow sides and along the inflow profile thereof.

In fig. 13, the delivery device 6 is shown coupled to the inner catheter 3' by means of a mooring structure 4 ", in its conical part and in the associated delivery device distal tube 6" fitted with a two-way normally closed valve. The same features already described for the preferred components apply here.

In fig. 14, the outer support structure 5 and the inner valve support stent 14 anchored to its inner wall are shown. This embodiment differs from the hybrid embodiment in that it lacks an internal metal support structure in order to optimize the low profile nature of the device, rather than having a separate valve anchoring.

In fig. 15, the sliding coupling between the outer support structure 5 and the tie down stay 4 "is shown from the outflow side.

Fig. 16-18 show the device 4 as originating from mixing, but the conveyor 6 system is placed at the proximal end outside the device. As can be seen in fig. 16, this embodiment can in principle guarantee a better alignment of the loaded device than the previous embodiments due to the longer distal delivery tube and an easier retrieval inside the small caliper outer catheter 3 due to the reduced number of elements placed one inside the other. At the same time, due to the higher length relative to the embodiment with internal conveyors, the coupling at 11' must be flexible in order to follow the aortic arch pattern at the proximal conveyor side while ensuring stable anchoring to the aorta at the distal end.

Fig. 16, 16a, 17, 18 show elements similar to the hybrid elements (i.e. the coupling between the prosthetic valve 15 and its supporting stent 14, the coupling between the mesh 10 and the outer structure 5) and the main differences: the delivery cone 6 is located at the proximal end, it is placed outside the outer structure 5, and half of the delivery cone 20 is covered at the distal end with a filter mesh having only the mechanical function of driving the loaded device towards the lumen in the conveyor; instead, the anti-embolus filter mesh 12 is located in the conical portion of the outer structure, distally with respect to the ring 11'.

In the following figures, some alternative embodiments of the outer support 5 and the support stent 14 of the valve are shown, without the conveyor system.

Fig. 16b, 16c, 16d and 16e show two laser cut and two braided alternative embodiments, respectively, of the outer structure 5 of the hybrid device 4, the ratio between diamond and straight elements being different in order to better accommodate the radial stiffness or retrievability characteristics.

Fig. 16f shows a self-expanding structure that combines the properties of the outer support structure 5 and the valve stent 14 support structure into one, which will serve as the last to retain the leaflet posts only. This embodiment aims to minimize the radial thickness of the support structure in order to maximize retrievability. Fig. 16g shows a self-expanding structure similar to a hybrid mesh, where two diamond-shaped structures at the inflow and outflow sides of the valve are joined by linear elements, in order to avoid total length changes of the region and skirt elements upon retrieval.

In fig. 19 to 20, a specific embodiment of the expansion device is depicted.

The purpose of using an expanded structure is to minimize the number of different materials involved in the manufacture and to allow the burden of folding the device to be reduced. Moreover, due to CO₂The radiopaque nature of the filler, which may allow for easy positioning of the device.

Several different embodiments can be applied to the expanded set, starting from the device 4 with all the expanded support structures (the carrier 6 inside the outer support structure 5 and the prosthetic valve 15 directly joined to the outer support structure) and ending at the device 4 (the outer support structure 5 and the longitudinal elements of the valve support stent 14 are made of self-expanding material (e.g. nitinol) and the carrier is outside the structure 5).

As far as the opening mechanism of the valve, intended to verify the relevant results of the diseased valve at the end of the recovery procedure, is concerned, different embodiments can be adopted which act directly on the leaflets 7 and/or on the support stent 14 of the valve by means of a rotating/pulling or rotating shaft mechanism, which is held proximally inside the inner catheter 3' and controlled by the delivery system.