Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/01—Filters implantable into blood vessels
  • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves

Definitions

• the invention relates to the technical field of interventional cardiology and endovascular and minimally invasive surgery and more particularly relates to an introducer device for transcatheter intervention.
• the invention finds an advantageous application, which should not however be considered as limiting for any type of surgical procedure, for example for a valve replacement or implantation of the valve by transcatheter route, more generally known for a person skilled in the art under the name TA VI.
• Any intervention by transcatheter means that the operator must take very great precautions, since for a cardiac procedure, for example, the circulation of the blood is not deviated, which is not the case, for example, for open-heart surgery where there is extracorporeal blood circulation.
• the generation of debris during the TA VI procedure from the aortic valve can generate postoperative coronary embolization, which leads to perioperative infarction, while cerebral embolization can cause iatrogenic stroke.
• the device comprises an assembly acting as a valvular embolic filter, mounted with sliding capacity guided inside said catheter, said assembly having arrangements capable of producing, in the aortic root, a safety enclosure ensuring a valve function and a function of protection against embolic accidents.
• the device makes it possible to perform various interventions by transcatheter means, for example, to remove calcified tissues and vegetations in and above the flaps of the aortic valve, to set up any type of valve, ... observing that the procedure is carried out under physiological circulation conditions and not under extracorporeal circulation.
• the arrangements of the assembly acting as a valved embolic filter comprise a tabular body that is attached at one of its ends to a part that can be freely rotated. the outside of the catheter, is retracted inside the catheter, said portion having filtration arrangements combined with means capable of reproducing a temporary valve function corresponding to an opening during the systolic phase and a closure during the diastolic phase so as to to prevent any blood regurgitation in an extended position of said portion to cover the native aortic valve with a secure seat in the aortic root at the Valsalva sinuses without obstructing the blood flow.
• the portion of the embolic filter is generally conical and has shells angularly offset whose contours surround the commissures of the native valve, said shells being mounted in combination with a membrane filter.
• the cone can be placed on the floor of the aortic root, in contact with the edge of the aortic ring, move remaining below the coronary ostium and at the same time bypass the commissures of the native valve .
• Positioning the valvular embolic filter on the aortic root around the commissures is very important to avoid acute aortic insufficiency during the transcatheter decalcification procedure.
• the filter membrane comprises, on the one hand, a lower layer consisting of a mesh network with a porosity adapted to block tissue debris, while allowing the passage of the blood flow and, on the other hand, an upper layer made of a flexible and extensible polymer material to act as a temporary valve, by simple deformation determined by the systolic pressure.
• the layers are welded together at the base of the conical shape and at its periphery, said weld being flexible and spongy to provide an optimal seating of the valve filter on the basis of the aortic root.
• the catheter has a radiopaque end adapted to protect the surrounding tissues during the introduction and navigation in the aorta.
• This end is retractable inside the tubular body of the assembly acting embolic filter.
• the end is an inflatable balloon filled with a sterile opaque radio solution.
• FIG. 1 is a partial perspective view showing in particular the assembly acting valve embolic valve.
• Figure 2 is a view corresponding to Figure 1 with a partial section.
• FIGS. 3 to 20 show the main steps for a transcatheter intervention by means of the device according to the invention in the case of an application to an aortic valve, such an application not to be considered as strictly limiting.
• the device according to the invention comprises a set (E) acting valve embolic filter, mounted with sliding capacity guided inside a catheter (1).
• the catheter (1) is equipped with the assembly (E) introduced into the aortic root (RA) by means of a wire guide (g) as is commonly practiced for this purpose. type of intervention.
• the filter assembly (E) has arrangements adapted to perform in the aortic root (RA), a safety chamber providing a valve function and a protection function against embolism accidents.
• This assembly (E) comprises a body (2) mounted to slide freely inside the catheter (1).
• the catheter (1) and the body (2) are made of a flexible material.
• the tubular body (2) is secured at one of its ends to a portion (2a) of generally conical shape and adapted to constitute the security enclosure as such.
• This portion (2a) may, at will, be deployed outside the catheter (1) is retracted within said catheter (1).
• This part (2a) has filtration arrangements combined with means capable of reproducing the temporary valve function corresponding to an opening during the systolic phase and a closure during the diastolic phase.
• the aim is therefore to prevent any blood regurgitation in an extended position of this part (2a) which constitutes the safety chamber with the aim of covering the native aortic valve with a secure seat in the aortic root and, more precisely , at the junction between the ring and the origin of the Valsalva sonus without obstructing the blood flow.
• the portion (2a) of the embolic filter is generally conical and has shells (3) angularly offset.
• these shells are offset by 120 ° to reproduce the position of the commissures of the native valve.
• the base of the conical part formed by the shells (3) can, therefore, be placed on the floor of the aortic root, move under the coronary ostium and, at the same time, bypass the three commissures of the native valve.
• the general conical shape can be adapted and present only two shells.
• the shells (3) are mounted in combination with a filter membrane (4).
• This filter membrane (4) comprises a so-called lower layer (4a) consisting of a mesh network with porosity adapted to block any tissue debris while allowing the passage of blood flow.
• This filtering cavity (4) has, moreover, another layer (4b) said upper, made of a thin, flexible and extensible polymer material to act as a temporary valve by simple deformation.
• the layers (4a), (4b) are fixed together at the base of the conical portion formed by the shells (3).
• this attachment is made by welding (5) around the base of the conical portion (2a). The weld is soft and spongy to provide optimal seating of the valve filter at the base of the aortic root.
• the lower mesh layer (4a) is attached to the end of the body (2) and an extension thereof by any known and appropriate means. For example, this attachment can also be made by welding.
• the upper layer (4b) serving as a valve is, therefore, free and remains open on top of the conical shape.
• the catheter (1) has a radiopaque end adapted to protect the surrounding tissues during its introduction and its navigation in the aorta.
• the end is retractable inside the assembly acting as an embolic filter and, therefore, retractable within the body (2) of the latter and the catheter (1).
• this end consists of an inflatable balloon (6) filled with a sterile radiopaque solution.
• FIGS. 3 to 20 showing the various sequences for the placement of an aortic valve, observing that the device can be applied for other heart valves such as tricuspids, mitral, pulmonary but also for introduction of instruments such as a decalcifier to obtain a remodeling of the implantation site.
• Figure 3 shows the aortic root while Figure 4 shows the same root after placement of the wire guide (g) which, in known manner, is engaged to cross the stenotic aortic valve.
• the entire introducer device including the catheter (1) equipped with the assembly (E) acting as valvular embolic filter and the balloon (6) is introduced into the descending aorta by means of the wire guide (g), FIG. It should be noted that the entire device can be introduced directly into the aortic root with a direct junction of the ascending aorta following transaortic access through a small thoracotomy or by means of an endoscopic trocar or by transcatheter through the femoral artery or through an access of peripheral self-bundles such as subclavian arteries or auxiliary arteries.
• the introducer catheter assembly is positioned at the tubular sino junction, FIG. 6.
• the end of the balloon is deflated, FIG. 7, so that its diameter is less than the internal diameter of the introducer device including the tubular body (2), Figure 7.
• the balloon (6) is then completely removed from the device, Figure 8.
• the device is then pushed to the level of the aortic root, Figure 9.
• the catheter (1) is then removed (arrow F), Figure 10, so that the portion of the end constituting the sheath (la) covering the assembly (E) of the valved filter releases the latter which is partially deployed , figure 10.
• the tubular body (2) is then pushed from the aortic root until the whole of the filter, by its external part resulting from the flexible welding, comes to take support in the Valsalva sinuses close to the Coronary ostium without obstructing coronary flow, Figure 1 1.
• the top layer (4b) of the membrane made of flexible and extensible polymeric material acts as a valve to ensure a complete valve function, Fig. 12, while the mesh network of the bottom layer (4a) blocks tissue debris.
• the shells (3) adapt, as indicated, to the commissures of the native valve allowing a good seal and a total seating of the device on the floor of the aortic root.
• the opening of the valved conical filter can be modified by acting on the catheter (1) whose end (la) forms a sleeve cooperating with said filter in order to modify the aperture of the filter in a restrictive manner, figure 13.
• the catheter (1) After checking the stable position of the catheter (1), it is possible to introduce, by catheter, the medical device chosen, for example, a valve (V), Figure 14. If necessary, prior to the establishment of the valve, it is possible to carry out a decalcification by any known and appropriate means.
• the introducer device may be removed and the transcatheter valve may be implanted.
• tissue removal has been complete with complete removal of the flaps, it is important to keep the introducer device in place to ensure temporary valve function in the absence of aortic insufficiency that could pose a threat to life. of the patient during the surgical procedure.
• the device can then be removed.
• Removal of the device consists of closing the filter membrane ensuring that the trapped debris is not embolized.
• the valvular filter is gently removed from the root of the aortic valve, Figure 15, and is gradually reintroduced into the interior of the catheter.
• the sheath (1a) of the catheter (1) is slid down between the polymeric material of the membrane and the polymer filter, FIGS. 16, 17 and 18, until reaching the end of the conical portion by progressively closing it until reversing the shells (3) which are retracted into the interior of the catheter (1) over the polymeric material by sliding to purge debris captured in the filter.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Surgical Instruments (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

Country Status (7)

Cited By (7)

Families Citing this family (17)

Citations (2)

Family Cites Families (10)

• 2014
  • 2014-06-05 FR FR1455144A patent/FR3021863A1/fr not_active Withdrawn
• 2015
  • 2015-06-04 EP EP15733803.9A patent/EP3151783B1/fr active Active
  • 2015-06-04 US US15/315,731 patent/US10568729B2/en active Active
  • 2015-06-04 JP JP2017516213A patent/JP6637969B2/ja active Active
  • 2015-06-04 CA CA2953211A patent/CA2953211C/en active Active
  • 2015-06-04 CN CN201580029968.XA patent/CN106794059B/zh active Active
  • 2015-06-04 WO PCT/FR2015/051488 patent/WO2015185870A1/fr not_active Ceased

Patent Citations (2)

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