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    • 专利摘要:
    it is an embolic protection device for transvascular delivery to a patient's aortic arch to protect the vessels of the lateral branch of said aortic arch against an embolic material. the device comprises a support structure, in which at least a distal or proximal portion of the support structure is a spring section configured to provide a radial force between the support structure and an aortic arch wall when in an expanded state.
    公开号:BR112019021265A2
    申请号:R112019021265
    申请日:2018-02-06
    公开日:2020-05-19
    发明作者:Amit Ashkenazi；Shemesh Tzeela Mikovski；Valentin Ponomarenko
    申请人:Keystone Heart Ltd；
    IPC主号:
    专利说明:

    DESCRIPTIVE REPORT DEVICE FOR FILTERING EMBOLIC MATERIAL IN A VASCULAR SYSTEM
    BACKGROUND OF THE INVENTION
    FIELD OF THE INVENTION
    [0001] This disclosure relates, in general, to devices and intra-aortic methods to prevent emboli from entering arteries that branch into the aorta, for example, arteries leading to the brain.
    BACKGROUND OF THE REVELATION
    [0002] Particles like plungers can form, for example, as a result of the presence of particulate matter in the bloodstream. The particles can originate, for example, from a blood clot in the heart. The particulate material can be a foreign body, but it can also be derived from body tissues. For example, atherosclerosis, or the hardening of blood vessels from fatty and calcified deposits, can cause the formation of particulate emboli. In addition, clots can form on the luminal surface of the atheroma, as platelets, fibrin, red blood cells and activated clotting factors can adhere to the surface of blood vessels to form a clot.
    [0003] Blood clots or thrombi may also form in the veins of immobilized individuals, particularly in the legs of bedridden patients or in other immobilized patients. These clots can then travel in the bloodstream, potentially into the arteries of the lungs, leading to a common and often deadly disease called pulmonary embolism. The formation of a thrombus and the subsequent movement to form an embolus can occur in the heart or other parts of the arterial system, causing an acute reduction in the blood supply and, therefore, ischemia. Ischemia damage often leads to tissue necrosis of organs such as the kidneys, retina, intestine, heart, limbs, brain or other organs, or even death.
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    [0004] Since the plungers are typically of a particulate nature, several types of filters have been proposed in an attempt to remove or divert these particles from the bloodstream before they can cause damage to body tissues. [0005] Various medical procedures can disturb the surrounding blood vessels or tissues. When this occurs, potentially dangerous particles, like plungers, can be released into the bloodstream. These particles can be harmful, for example, if they restrict blood flow to the brain. Devices to block or divert the flow of particles to specific regions of the vasculature have been proposed, but they have not been able to eliminate the risks associated with the release of potentially dangerous particles into the bloodstream during or after specific medical procedures.
    [0006] Enhanced devices are under development to block or deflect vascular particles, but each intravascular procedure presents unique risks.
    [0007] As intravascular devices and procedures, such as transcatheter aortic valve implantation (TAVI), become more advanced, there is an emerging need for resources that provide these devices with greater ease of use, intravascular stability and embolic protection.
    [0008] Possible areas for improvement of such devices and procedures include windsailing of devices with pulsatile blood flow, leakage of fluid and / or particulate material in peripheral portions of devices while using them, safe positioning on a patient during use and / or recoverability, etc.
    [0009] Therefore, an improved intravascular device, system and / or method would be advantageous and, in particular, would allow greater flexibility, better cost-benefit and / or patient safety.
    SUMMARY OF THE INVENTION
    [0010] Consequently, examples of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages
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    3/27 or problems in the technique, such as those identified above, alone or in any combination, providing a device, system or method according to the attached patent claims to provide a retractable embolic protection device for vascular delivery to an aortic arch of one patient, to protect vessels from the lateral branch of the aortic arch of embolic material.
    [0011] In some aspects of the disclosure, an embolic protection device for vascular administration to a patient's aortic arch is described for protecting vessels of the lateral branch of the aortic arch from embolic material. The device includes a support structure, in which at least a distal or proximal portion of the support structure can be a spring section configured to provide radial force between the support structure and an aortic arch wall when in an expanded state. The device may also include a filter member attached to the support structure and configured to prevent embolic material from flowing with blood to the side branch vessels of the aortic arch.
    [0012] Other examples of the embolic protection device are revealed according to the description and the dependent claims.
    [0013] It should be emphasized that the term understand / understand when used in this specification is used to specify the presence of declared characteristics, integers, steps or components, but does not prevent the presence or addition of one or more other characteristics, integers, steps, components or groups of them.
    BRIEF DESCRIPTION OF THE DRAWINGS
    [0014] These and other aspects, characteristics and advantages of which the examples of the revelation are capable will be apparent and elucidated from the following description of the examples of the present revelation, with reference to the accompanying drawings, in which the schematic illustrations of the
    [0015] Figures 1A and 1B are illustrating an example of a
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    4/27 embolic protection for transvascular administration;
    [0016] Figures 2A and 2B are illustrating an example of an embolic protection device for transvascular administration;
    [0017] Figures 3A to 3D are illustrating examples of embolic mounting protection devices for transvascular administration;
    [0018] Figure 4 is illustrating an example of an embolic protection device for transvascular administration with an extended or extended filter element;
    [0019] Figures 5A and 5B are illustrating additional examples of spring segments to improve the spring effect;
    [0020] Figures 7A and 7B are illustrating examples of connecting the device to a delivery unit;
    [0021] Figures 8A to 8D are illustrating an example of an embolic protection device connected to a delivery system including a wire or tube; [0022] Figures 9A to 9C are illustrating an additional example of connecting the device to a delivery unit;
    [0023] Figures 10A to 10C are illustrating an additional example of connecting the device to a delivery unit;
    [0024] Figures 11A to 11B are illustrating an example of a stop member;
    [0025] Figures 12A to 12C are illustrating examples of embolic protection devices positioned in an aortic arch; and
    [0026] Figures 13A to 13E are illustrating an example of a dome shaped filter element;
    [0027] Figures 14A to 14C are illustrating an example of adhesives or plasters that can be used at the distal and / or proximal end of the embolic protection device; and
    [0028] Figures 15A to 15C are illustrating an additional example of connecting the device to a delivery unit.
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    DESCRIPTION OF EXAMPLES
    [0029] The following disclosure focuses on examples of the present disclosure applicable to an embolic protection device, such as a retractable embolic protection device, for vascular delivery to a patient's aortic arch to protect the vessels of the lateral branch of the aortic arch against embolic material.
    [0030] Figure 1A is illustrating an embolic protection device 1000. The embolic protection device is retractable, as crimpable, to be arranged in a transvascular delivery unit. The protective device 1000 includes a support structure 10 and a filter element 11 connected to the support structure 10. The support structure can in some instances be a complete rim that completely surrounds a periphery of the filter element 11. In In some examples, the filter element 11 can extend (partially or totally) outside the periphery defined by the support structure 10 and, thus, create a necklace or ring, as illustrated in Figure 4. The necklace or ring can improve the apposition with the rough texture of the vase wall. In some instances, the collar or rim may be made of a material other than the filter element 11.
    [0031] The protection device 1000 can also include the connection point in the support structure 10 or in the filter member 11.0 connection point is used to connect the embolic protection device 1000 to a transvascular delivery unit. Preferably, the connection point is arranged off-center in a proximal portion of the embolic protection device 1000. In some examples, a connection point can be arranged on a rod at a distance from the filter membrane 11 and the support structure 10.
    [0032] To position a protective device 1000 in an aorta, the disclosure device 1000 can be attached and delivered by a transvascular delivery unit, for example, as illustrated in Figure 1B. The transvascular delivery unit can be, for example, a catheter or sheath, and the
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    6/27 protective device 1001 may be connected to the transvascular delivery unit according to methods known in the art, or by a connector mechanism 20. In some examples, the transvascular delivery unit may comprise a connector mechanism 20, such as a wire, rod or tube, for example, a rope, a delivery wire or a pressure wire etc. The connector mechanism 20 can be connected to the connection point. In some instances, the connector mechanism 20 can be permanently connected to the embolic protection device 1001. Thus, the embolic protection device 1001 can be delivered and removed using the same connector mechanism 20. In addition, the connector mechanism 20 can be used to hold the embolic protection device 1001 during a medical procedure. In some examples, the connector mechanism 20 can be detachably connected to the embolic protection device 1001.
    [0033] The distal end and / or the proximal end of the support structure 10 can be manufactured from a spring section 12, 13. Each spring section 12, 13 is a preloaded spring that functions as a motor and is configured to quickly expand or open a collapsed or crimped embolic protection device 1000 from a collapsed state to an expanded state and to provide radial force between the support structure 10 and a wall of the aortic arch, when the support structure 10 is in an expanded state. The spring sections 22, 23 are motors being pre-molded open springs. Spring sections 22, 23 may have a wider radius than the embolic protection device. Different radii of the aperture can provide different forces.
    [0034] The spring sections can provide better positioning with the walls of the aortic arch, which can improve the fixation of the device 1000 and the seal between the device and the wall of the aorta, which can reduce the leakage of the para-structure. The strength of the spring sections can also prevent distortion of the support structure 10 when a radial force is applied. The strength of
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    7/27 spring sections 12, 13 also tends to position the embolic protection device 1000 at approximately the average diameter of the vessel, as illustrated, for example, in Figures 12A to 12C. Therefore, it provides an embolic protection device with better self-positioning and alignment properties.
    [0035] The force provided by the spring sections 12, 13 can also reduce windsailing, in most cases to zero.
    [0036] The spring sections 12,13 are preferably heat treated to form the spring sections and provide spring properties. The spring sections are, in some examples, formed as open springs and are wider than the protective device before mounting the device.
    [0037] When organizing a spring section 13 proximally, there will be an improved coverage of the rest zone. The rest zone is the area where all the guidewires will reach the aortic arch, see reference 80 in Figure 12C. An improved cover and sealing of the rest zone can help prevent devices from passing over (along) the protective device 1000 (through the aortic arch), for example, by carrying a guidewire below the protective device 1000.
    [0038] Each spring section 12, 13 has a fold shape, like a shallow U shape, or is curved. In examples where the support structure 10 has only a spring section 12,13 at the distal or proximal end, the rest of the support structure 10 has a deeper U-shape. This deeper U-shape does not have the same elastic properties as the molal section 2, 13. In the examples where the support structure 10 has a spring section 12, 13 at the distal and proximal ends, the support structure can have sections straight center 18, 19 formed between spring sections 12, 13. When using straight center sections 18, 19, these are substantially straight before mounting the device. After assembling the device, the straight center sections 18, 19 may protrude or obtain curvature due to forces in the
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    8/27 support structure of the spring sections, compare for example with Fig 2B. [0039] In some examples, the support structure 10 can be made of two parts, the first part of which can be a spring distal section 12 which can be precast to a shallow U shape. The second part can be the proximal section of the spring 13 and the side sections 18, 19, which can be precast to a deeper U shape than the first part.
    [0040] Alternatively, and / or additionally, in some examples, the support structure 10 can be made of two parts, the first part of which can be a distal spring section 12 which can be pre-shaped into a U-shape shallow. The second part can be the proximal section of the spring 13 and the side sections 18, 19 which can be a straight wire (in addition to a possible spring element) that is shaped into a deeper U-shape when attached to the distal section of the spring 12.
    [0041] Alternatively, the support structure 10 can be made of two parts, the first part of which can be a proximal spring section 13 which can have a shallow U-shape. The second part can be the distal section of the spring 12 and the side sections 18, 19 which can be shaped into a deeper U-shape than the first part. In some instances, the center straight sections may function as spring motors in a longitudinal direction of the embolic protection device.
    [0042] Additionally, and / or alternatively, in some examples, the spring sections 12, 13 are heat treated to form the spring sections, while the rest of the support structure 10 is not heat treated. This will give the support structure 10 a flexibility that can further improve the placement of the embolic protection device 1000 with the walls of the aortic arch, since it adapts better to the rough texture of the vessel wall.
    [0043] In addition, when thermally treating all sections, there may be forces at the transitions between the segments, such as at the joints between the segments, applicable to the aortic arch wall. In addition, if the yarn is manufactured with a
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    9/27 single wire being heat treated, there will be fewer connectors to join the different sections, which can also improve the forces of transitions between the segments to the aortic arch wall.
    [0044] An advantage of thermally treating only the spring sections 12, 13 and not the other sections, is that the forces of the spring sections will be comparatively stronger.
    [0045] To further improve the strength, some segments can be made thicker than others, for example, at the distal end of the support structure 10, the distal spring section 12 can be thicker than the rest of the support structure and weaker proximally. This can also facilitate the crimping of the support structure 10, for example, in a catheter lumen for delivery or to improve the output of that lumen when implanting the embolic protection device.
    [0046] Alternatively, in some examples, the distal and proximal spring sections are thicker than the rest of the support structure. This will improve the spring forces at the proximal and distal ends. The thicker springs can open the support structure, while the thinner sections are more compatible with the vessel wall.
    [0047] Alternatively, in some examples, the distal section of spring 12 may be thicker than the proximal section of spring 13. Furthermore, in some examples, intermediate sections 18, 19 may be made of the same thickness as the proximal section 13. In some other examples, the intermediate sections 18,19 are made of the same thickness as the distal section 12.
    [0048] Alternatively, in some examples, the spring sections and the central sections are thicker than the joints or transition segments between the thicker sections which can be thinner. This will provide strong forces on all sides, while avoiding stiffness problems throughout the support structure. Making the entire support structure rigid can force the spring sections to close and not effectively cover anatomies
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    10/27 tortuous with the embolic protection device.
    [0049] Using different thicknesses or cross sections of different sections, a support structure can be obtained having a configuration with different forces in different segments. Additionally, and / or alternatively, the at least distal or proximal spring section 12, 13 may include a spring element 14, 15. The spring element 14, 15 may in some instances be a ring or prop, a small spring or any other type of spring arranged approximately in the center of each of the distal or proximal section of spring 12, 13. The spring element 14, 15 is used to increase the force applied by the support structure 10 on the walls of the aortic arch.
    [0050] As previously described, the spring sections 12,13 are used to apply force by the support structure 10 on the aortic arch wall, which can improve the sealing effect between the retractable embolic protection device and the wall of the aortic arch. aortic arch, as well as providing an enhanced self-stabilizing effect. In addition, the use of spring sections 12, 13 can improve the positioning and self-alignment of the device in the aortic arch. [0051] Additionally and / or alternatively, in some examples, the connector mechanism 20 can be attached to the support structure 10, allowing the protection device to rotate axially, but not radially, at the joint between the support structure and the connector mechanism 20, for example fixing the connector element through the proximal ring 15.
    [0052] The spring element, especially the proximal spring element 14, may, in some instances, function as a crimp element to improve the collapse of the embolic protection device, elongating the device longitudinally. Thus, the embolic protection device 1000 must be crimped in a small diameter sheath.
    [0053] Spring elements 14, 15 may, in some examples, for example, when spring elements 14, 15 are hoops, be formed to project outwards (the relative occupied periphery / region defined by the structure
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    11/27 of support) or formed to project inward (in relation to the occupied periphery / region defined by the support structure) as illustrated in Figure 1A. Providing or forming one or more of the spring elements 14,15 to project inwards improves the attachment of the filter member 11 to the support structure 10. In addition, having one or more of the spring elements 14,15 arranged to project inward improves the contact between the support structure 10 and the walls of the aortic arch, as there is nothing protruding or extending beyond the support structure 10 (position smoother to the tissue of the vessel of the aortic wall, improved by a necklace mentioned in this document).
    [0054] The support structure 10 can be made of a wire, such as a spring wire, or be laser cut from a tube, tape, sheet or flat wire, etc. The support structure 10 can be a single wire. In some examples, the support structure 10 is made of a single twisted wire. Alternatively, in some examples, the support structure 10 can be made up of at least two threads being twisted, braided or knitted.
    [0055] The support structure 10 can, in some examples, be made of a ring without a joint. In other examples, the support structure 10 is formed from a ring with at least one joint 17. A joint 17 can be, for example, a fixture such as a weld, braze or a clamp.
    [0056] The support structure 10 can be molded in an elongated shape, in the form of a substantially elliptical, oblong, oval or cone groove. Alternatively, other shapes can be used, such as circular or rectangular. Because aortic anatomy can vary between individuals, examples of the intra-aortic device of the revelation can be modeled to suit a variety of aortic anatomies.
    [0057] An example of an elongated or oblong-shaped support structure 10 can be a slit-shaped support structure 10, as shown in Figure 1 A. A retractable embolic protection device 1002 with a support structure in the form of a slit conical slot 10 is illustrated in Figure 2A. A device
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    12/27 of retractable embolic protection 1003 having an elliptical shaped support structure 10 is illustrated in Figure 2B.
    [0058] The size of the retractable device can be pre-sized and pre-shaped to accommodate various groups of patients (eg children and adults) or a specific aortic anatomy. The support structure 10 may, in some examples, be substantially flat. In some examples, the support structure 10 may have a width greater than the diameter of the aortic arch in which it is configured to be positioned in use, as about 50% greater than the diameter of the aortic arch, as 50% greater than the transversal chord of a subject's aorta, in which the retractable embolic protection device 1000 can be placed. In addition, in some examples, a support structure 10 may be larger than the opening of the aortic arch, as about 20% larger than the opening of the arch, as 20% greater than an approximate distance between the upper wall of the ascending aorta of a subject, distal to an opening of an innominate artery and the upper wall of a subject's descending aorta, proximal to an opening of a left subclavian artery.
    [0059] By making the support structure 10 wider than the diameter of the arch, as about 50% wider, and larger than the opening of the aortic arch, as about 20% larger, as defined above, the self-positioning of the device the positioning on the average diameter of the vessel can be improved, thus improving the apposition with the walls of the aortic arch. This will facilitate the implantation of the embolic protection device and improve the sealing against the walls. It can also improve coverage of the three lateral vessels, innominate artery (brachiocephalic), left common carotid artery or left subclavian artery) that are supplying blood to the brain.
    [0060] The support structure 10 can be manufactured wholly or partially from, for example, nitinol or metal, alloy material with shape or superelastic memory, easily malleable material or polymer, for example, nylon. The metal can include, for example, tantalum or platinum.
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    [0061] Filter element 11 prevents particles (e.g., plungers) typically having a size between about 50 pm and about 5 mm (e.g., 50 pm, 100 pm, 200 pm, 300 pm, 300 pm, 400 pm, 500 pm, 750 pm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm) in an aorta passing through blood vessels (eg innominate artery (brachiocephalic), left common carotid artery or subclavian artery left) supplying blood to the brain. Therefore, one or more lateral dimensions of the filter pores can be between about 50 pm and about 5 mm (for example, 50 pm, 100 pm, 200 pm, 300 pm, 400 pm, 500 pm, 750 pm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm). The filter can be, for example, a mesh made of a plurality of fibers made of polymer, nylon, nitinol or metal or a combination thereof. The mesh can be made of woven fibers. The fibers can be between 20 and 50 pm thick. Alternatively, the filter can be a perforated film. When a perforated film is present, the pores formed in the perforated film may include pores of varying or non-varying shape (for example, straight or rhomboid pores), have varying or constant density in the film and / or constant or varied size. The pore size of the filter allows the passage of red blood cells (eg red blood cells (erythrocytes), white blood cells (leukocytes) and / or platelets (thrombocytes)) and plasma, in addition to being impervious to larger particles (eg emboli) than the pore dimensions. The plungers filtered by the filter mesh of the present disclosure are typically larger particles in one or more dimensions than a filter mesh opening.
    [0062] In some embodiments, a filter member or mesh can be configured from woven fibers and is affixed to a support structure, so that its thread orientation is at angles that are not perpendicular to the support structure. For example, in some embodiments, the mesh can be attached to the support structure, so that the fabric (warp and weft) of the mesh or fabric can be, for example, at 45 ° angles from a
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    14/27 base or side portion of the support structure. In some instances, the fabric (warp and weft) of the mesh may be, for example, at 30-60 °, such as 3555 °, angles from a base or side portion of the support structure. When adjusted at a non-right angle to the support structure, the mesh can stretch, expand or contract with greater flexibility than when this fabric is at right angles to the support structure. The collapsibility or crimping capability of the embolic protection device is advantageously improved in this way.
    [0063] Various catheters or sheaths can be used as part of the present disclosure. Any catheter or sheath known in the art configured to guide medical instruments through the vasculature can be used (for example, stenting catheter, ablation catheter or those used for transcateter aortic valve catheter (TAVI) implantation or valve replacement procedures percutaneous aortic valve (PAVR), for example, as described in US Patent No. 5,026,366). Additionally or alternatively, the device may include a pigtail catheter, which may be 6F or smaller in size (for example, 1F, 2F, 3F, 4F, 5F or 6F) and includes radiopaque material to facilitate tracking of the progress of various elements of the device. Other catheters that can be used as part of the disclosure include any catheter used in procedures associated with a risk of embolism, which would benefit from including an intravascular filter as part of the procedure.
    [0064] The filter element 11 can be substantially flat or dome-shaped. The dome shape of the filter element 11 can be in some examples about the size of the support structure 10.
    [0065] Alternatively, in some examples, the filter element 11 may be dome-shaped at the distal or proximal end. A dome-shaped filter membrane 11 can improve the space under the embolic protection device 1000. It can also improve the filter due to a larger filter area. [0066] A developing device may incorporate radiopaque elements. Such
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    15/27 radiopaque elements can be attached or incorporated into the device. For example, parts of the structure, filter or catheter can be constructed with OFT wire. Such wire may contain, for example, a tantalum and / or platinum core and an external material of, for example, nitinol.
    [0067] Figure 1B is illustrating a system 1001 of a retractable embolic protection device 100 according to the description, as illustrated in Figure 1A. The embolic protection device 100 is connected to a transvascular delivery unit. The transvascular delivery unit is illustrated here with a connector mechanism 20 which is a wire or rope. The connector mechanism 20 can be made of a biocompatible metal and is attached to the support structure of the embolic protection device 100. The connector mechanism of the structure 20 is illustrated here as directly connected to the spring element of the support structure. The accessory can be made by a ring, lock or a clamp. The accessory must be strong and flexible enough to push the device out of its sheath. Figure 1B further illustrates a tube or sheath 21 used to provide the embolic protection device 100 used to supply the embolic protection device 100 to the work zone.
    [0068] Figure 3A is illustrating a way to manufacture the support structure of the protection device. Fig 3A here illustrates a wire 1100, such as a spring wire, which has been heat treated to form the different sections of the support structure. 110 and 111 are spring sections that will form the distal and proximal section of the spring when the two ends of the wire are joined. The spring sections are preloaded and shaped to be straight; therefore, they are open springs with an opening greater than the width of the final device. When the two ends of the wire are joined, the straight sections 100 and 102 will provide a straight center section, while the straight section 101 will provide the second straight center section. In some instances, straight sections are heat treated to be straight. Alternatively, in some examples, straight sections are not
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    16/27 heat treated.
    [0069] Figure 3B is illustrating an alternative way of fabricating the support structure of the protection device from a wire 1101, such as a spring wire. In this example, wire 1101 was heat treated to form the different sections of the support structure. 130 and 131 are spring sections that will form the distal and proximal section of the spring when the two ends of the wire are joined. The spring sections are preloaded and shaped to be curved. The openings of the spring sections are here larger than the width of the end device. When the two ends of the wire are joined, the straight sections 120 and 122 will provide a straight center section, while the straight section 121 will provide the second straight center section. In some instances, straight sections are heat treated to be straight. Alternatively, in some instances, straight sections are not heat treated.
    [0070] Figure 3C is illustrating an alternative way of fabricating the support structure of the protection device from a wire 1102. Wire 1102 is a ground wire with more than one conical section. In the illustration, there are three thicker sections and two thinner sections 151, 152. The thinner sections can form into two straight central sections, while the three thicker sections 140, 141, 142 will form two spring sections when the two ends of wire 1102 are joined.
    [0071] Additionally, and / or alternatively, in some examples, the thicker sections 140, 141, 142 that will form the two spring sections may have spring elements. In some examples, the thicker sections 140,141,142 that will form the two spring sections can be curved as in Figure 3B.
    [0072] Additionally, and / or alternatively, in some examples, wire 1102 may include thicker conical sections, similar to the sections used for spring sections, to be used for straight center sections. Between the thicker conical sections, there will be thinner sections forming joints or transitions between the different spring sections and the straight center sections.
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    [0073] A wire 1102 with thicker conical sections with thinner sections between them can allow a wire 1102 to be configured to result in a support structure with different forces in different segments.
    [0074] In addition, instead of having a single rectified wire 1102 as in Figure 3C, each section can be formed from a single rectified wire with only a thicker conical section and thinner segments on the sides. These sections can then be joined as shown in Figure 3D.
    [0075] Figure 3D is illustrating an embolic protection device 1004, in which the support structure is made up of 4 separate segments, functioning as motors. The segments include a distal spring section 22, a proximal spring section 23 and two central straight sections 24a, 24b. A filter element 11 is attached to the support structure.
    [0076] Each of the distal and proximal spring sections 22, 23 can have a spring element 14,15. The spring sections 22, 23 are motors that have pre-molded open springs, which in some examples have a shallow U-shape. In some other examples, the spring sections are straight before mounting the support structure. Spring sections 22, 23 may have a wider radius than the embolic protection device. Different radii of the aperture can provide different forces.
    [0077] Between the spring sections 22, 23 are arranged central straight segments 24a, 24b. In some examples, the straight center segments 24a, 24b are not heat treated, whereas the spring sections 22, 23 are.
    [0078] In some examples, the proximal spring 23 and distal 22 sections may differ, for example, by providing different amounts of forces. The distal spring section 22 can provide better placement with the walls of the aortic arch, which can improve the fixation of the device 1004 and the seal between the device and the aortic wall, which can reduce leakage of the parapet. The proximal section of spring 23 covers the resting area of the embolic protection device. The rest zone is the area where all guidewires
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    18/27 reach the internal wall of the aortic vessel when introduced by the femur to the aortic arch. Therefore, a better position is obtained between the embolic protection device and the walls of the aortic arch as an advantage.
    [0079] Due to the positioning of the proximal end, a strong force is not as important as at the distal end of the device. Different forces can be provided by making the distal section of spring 22 thicker than the proximal section of spring23. The spring element 14 in the distal section 22 can also be configured to provide a stronger force than the spring element 15 in the proximal spring section 23.
    [0080] In some examples, only one of the spring sections 22, 23 includes a spring element 14, 15. The spring element 14, 15 can also be used to improve the crimping of the device. In addition, having the proximal spring section 23 being made of a thinner material than the distal spring section 22, it can also improve the crimping of the device, as the force will be weaker in the proximal section 23.
    [0081] Figure 4 illustrates a retractable embolic protection device 1005 that has a filter element 11 that can extend outside the support structure 10 and thus create a necklace or ring 25. The necklace or ring 25 can improve the apposition with the rough texture of the vase wall. Thus, the peripheral seal can be improved, especially when the pulsatile flow presses the collar or rim against the tissue of the internal aortic arch vessel. In some instances, the necklace or ring may be made of a material other than the filter element 11, such as PTFE or a fabric, for example Dacron. The collar may have, in addition or alternatively, an unfiltered configuration, such as a sheet of unfiltered material, for example a film.
    [0082] Figures 5 and 6 are illustrating two examples of spring elements 14 in the distal spring section of the device 1006. The same type of spring element can be used in the proximal section of the spring.
    [0083] In some examples, different spring elements are used in the
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    19/27 distal end and proximal end.
    [0084] Those skilled in the art will readily appreciate that other spring elements than those illustrated here can be used to achieve the same effect of improving the strength of the spring section against the aortic arch wall.
    [0085] Figure 5 illustrates a spring element 14 being a rim 27 formed from the material 26 used to mold the distal section of the spring, here it is illustrated as a wire, as a spring wire.
    [0086] Figure 6 illustrates a spring element 14 with a spring 28 attached to a clearance in the distal section of the spring by clamps 29a, 29b. The cross section of the structure can, in this way, be maintained in that of the structure by having an intermediate spring, like the one shown in Figure 6.
    [0087] Figures 7A and 7B are illustrating two examples of connecting device 1007 to a connector mechanism 20, such as a wire, rod or tube, for example, a rope, a delivery wire or a pressure wire etc.
    [0088] Figure 7A is illustrating the connection point 30 that is arranged in the proximal spring section of the support structure. The connector mechanism 20 is here a twisted wire 31 twisted around the support structure. In some instances, the connector mechanism 20 is locked at a predefined angle. In some other examples, the connector mechanism 20 is made so that the protective device can rotate in an axial direction at the connection point. In some instances, the device is prevented from rotating in a radial direction. In some examples, the connection is made to fix the protection device at a predefined angle.
    [0089] Figure 7B is illustrating the connection point 30 that is arranged in the proximal spring section of the support structure. The connector mechanism 20 is here a single wire 32 connected to a ring in the proximal spring section. In some other examples, the connector mechanism 20 is made so that the protective device can rotate in an axial direction at the connection point. In some instances, the device is prevented from rotating in a radial direction. In some
    Petition 870190101625, of 10/10/2019, p. 24/163
    20/27 examples, the connection is made to fix the protection device at a predefined angle.
    [0090] Figures 8A to 8D are illustrating an example of embolic protection device 1008 being disposed on a wire, tape or tube, like a main tube or shaft tube, 35. The wire, tape or tube, like a main tube or shaft tube, 35 is used to provide the embolic protection device 1008. The wire, tape or tube can be made of plastic commonly used for catheters or metals, such as a shape memory alloy, such as Nitinol.
    [0091] In Figure 8A, a twisted wire 36 is used as a connector mechanism. The twisted wire 36 is molded into a ring 33 at the distal end and is connected to the spring element 15, which here also functions as a connection point. The twisted wire 36 is attached to the wire, tape or tube 35 using at least one ring 34a, 34b.
    [0092] Wire 36 can be manufactured from an alloy with shape memory, such as Nitinol. The wire 36 can be a twisted and heat treated wire in a template and thus formed in the flexible connector mechanism. The wire 36 can place the embolic protection device 1008 perpendicular to the fold of the wire tube 37, as seen in Figures 8B to 8D. In some instances, the device may rotate at the connection point in an axial direction, for example, during implantation in the aortic arch. In some instances, the device is prevented from rotating in the radial direction. The arrangement on the wire helps to support the filter member by pushing or forcing the filter member or support structure upwards by a dedicated bent tube or wire 37. The arrangement also helps to hold the embolic protection device 1008 in place by same upward thrust or force, the bent tube or wire 37. The arrangement can also improve the positioning of the embolic protection device 1008 in the aortic arch.
    [0093] Figures 9A to 9C are illustrating an additional example of embolic protection device 1009 being connected to be arranged over a wire or tube 35 used to provide the embolic protection device 1009.
    Petition 870190101625, of 10/10/2019, p. 25/163
    21/27
    [0094] In the illustrated example, the connector mechanism 41 is made of a laser cut tube. The distal end of the connector mechanism 41 is cut like a ring or hole 38 used to attach the connector mechanism 41 to the embolic protection device 1009. The connector mechanism 41 can be attached to the frame or to a ring-shaped spring section 15. The distal end of the connector mechanism 41 can be shaped to have two branches, as seen in Figure 9B, each branch having a ring or hole.
    [0095] The proximal end of the connector mechanism 41 is formed as a connector 39 and used to connect the connector mechanism 41 to the wire or tube 35. To fix the connector mechanism 41 to the wire or tube 35, a stop 40 is used. An example of a stop 40 is shown in Figures 11A and 11B.
    [0096] In some examples, the stop 40 is welded to the wire or tube 35 to better fix the connector mechanism 41 in the necessary position.
    [0097] In some examples, the device can rotate at the connection point in an axial direction, for example, during implantation in the aortic arch. In some instances, the device is prevented from rotating in a radial direction.
    [0098] Figures 10A to 10C are illustrating an additional example of the embolic protection device 1010 connected to be arranged on a wire or tube 35 used to provide the embolic protection device 1010.
    [0099] In the illustrated example, the connector mechanism 42 is made of a laser cut tube. The distal end of the connector mechanism 42 has a ring 43 welded to it. Ring 43 is used to attach the connector mechanism 42 to the embolic protection device 1010. The connector mechanism 42 can be attached to the frame or to a spring section 15 in the form of a ring.
    [00100] The proximal end of the connector mechanism 42 is formed as a connector 44 and used to connect the connector mechanism 42 to the wire or tube 35. To fix the connector mechanism 42 to the wire or tube 35, a stop 40 is used. An example of a stop 40 is shown in Figures 11A and 11B.
    [00101] In some examples, the stop 40 is welded to the wire or tube 35 to
    Petition 870190101625, of 10/10/2019, p. 26/163
    22/27 better fix the connector mechanism 42 in the necessary position. In some instances, the device may rotate at the connection point in an axial direction, for example during implantation in the aortic arch. In some instances, the device is prevented from rotating in the radial direction.
    [00102] Figure 12A is illustrating a protection device 1012 disposed in the aortic arch. The device is delivered and maintained by the catheter or sheath 60 during the procedure. In the illustrated example, the protective device 1012 covers all three lateral branches of the aortic arch.
    [00103] Figures 12B and 12B are illustrating a protection device 1013 disposed in the aortic arch. The device is connected to a wire or ribbon or tube 72 by a connector mechanism 71.
    [00104] The device is delivered through the catheter or sheath 70.
    [00105] The wire or tape or tube 72 has an expanding tip 73.
    [00106] The dilator tip 73 can be an atraumatic tip.
    [00107] Figures 12B and 12B are illustrating that the curvature of the wire or tape or tube 72 helps to support the filter member by pushing or forcing the filter member or support structure upwards. The arrangement also helps to hold the embolic protection device 1013 in place using the same upward thrust or force through the bent tube or wire 72. Figure 12C is illustrating the resting zone 80.
    [00108] In some examples, the wire, tape or tube 72 can be pre-folded. Pre-curvature can be calculated based on the curvature of the anatomy of the aortic arch. An advantage of this is that it can prevent the embolic protection device from turning during insertion or during a procedure when the embolic protection device is disposed in the aortic arch.
    [00109] Figures 13A to 13E are illustrating a method for manufacturing a dome-shaped filter element 1011. The dome-shaped filter element 1011 can be made of a woven mesh 50 made from, for example, a polymer , such as polyether ether ketone (PEEK). The shaped filter element
    Petition 870190101625, of 10/10/2019, p. 27/163
    Dome 23/27 1011 can be formed by cutting openings or wedges 51a to 51 d in the mesh material 50, see for example four wedges in Fig 13A.
    [00110] The dome shape is then shaped by fixing the edges of each opening or wedge 51a to 51 d. Through gluing, heat welding, ultrasonic welding etc., 4 seams 52a to 52d will be obtained, as illustrated in Figure 13B.
    [00111] The formation of heat allows the dome-shaped filter element 1011 to obtain a three-dimensional shape from a layer of flat 2d mesh. The three-dimensional shape of the dome is illustrated in Figures 13C to 13E. In some instances, the dome's three-dimensional shape is seamless. In some examples, the three-dimensional shape of the dome is thus formed without creases as illustrated in Figures 13C to 13E.
    [00112] In some examples, the three-dimensional structure, such as the dome shape, may appear almost flat when attached to the structure and the structure is not restricted. When the structure is restricted, as by the walls of the aortic arch, the mesh returns to the formed three-dimensional structure.
    [00113] Figures 14A to 14C are illustrating an example of adhesives or plasters 1014, 1015 that can be arranged at the distal and / or proximal end of the embolic protection device 1016. The adhesive or patch 1014, 1015 can preferably be made of an elastic material, such as polyurethane. The adhesive or plaster 1014,1015 can be solid or porous, as made as a mesh. The adhesive or plaster 1014, 1015 may be in the form of a square or rhombus, as having a diamond shape.
    [00114] In Figures 14A and 14B, the distal adhesive 1015 and the proximal adhesive 1014 are sized as diamonds, but with a cutout in the middle, creating a waist section 102. The waist section 102, 104 facilitates the attachment of the adhesive or plaster 1014,1015 to the embolic protection device 1016, since there will be less material bent or stretched around the structure 103 and, therefore, fixed to it. Due to the curvature of the structure, the adhesive
    Petition 870190101625, of 10/10/2019, p. 28/163
    24/27 or plaster 1014,1015 cannot be folded or stretched smoothly and attached to structure 103, which can cause wrinkles in the adhesive or plaster 1014, 1015 on structure 103. This can be avoided by having a waist section 102, 104, as illustrated in Figures 14A and 14B.
    [00115] Alternatively, in some examples, adhesives or plasters 1014, 1015 can be triangular. When triangular, the adhesive or plaster 1014, 1015 is not folded around the structure 103, instead, they are attached only to one side of the filter of the embolic protection device 1016.
    [00116] The proximal adhesive 1014, shown in Figure 14A, has a cutout in the middle 104, which allows a connector mechanism 101 to be used to connect the embolic protection device 1016 to a wire, tape or tube, as previously described here .
    [00117] The adhesives or plaster 1014,1015 are adhered to the filter mesh of the embolic protection device 1016. The adhesive or plaster 1014, 1015 can adhere to the embolic protection device using glue or an adhesive layer. The adhesive or plaster 1014, 1015 can also be fixed using heat. In some instances, glue or adhesive layer is used with heat to attach the adhesive or plaster 1014, 1015 to the embolic protection device 1016.
    [00118] The adhesive or plaster 1014,1015, can provide more resistance to the embolic protection device 1016 when crimped. The patch or plaster covers part of the structure from the blood, where the thrombus may otherwise be formed.
    [00119] The adhesive or plaster 1014, 1015, can also be used to fix the mesh of the embolic protection device 1016 to the structure 103 at the distal and / or proximal end. This can have an advantage when the distal and / or proximal spring section has a spring element, such as a rim or prop. By avoiding sticking the mesh to the spring element and instead using the adhesive or patch 1014,1015 to secure the distal end of the proximal end of the
    Petition 870190101625, of 10/10/2019, p. 29/163
    25/27 mesh to structure 103 at that point, the spring elements can be more effective, because they are not restricted by mesh or glue. This can be achieved by not having adhesive means, such as glue on the waist section 102, 104, which is stretched over the frame and the spring element.
    [00120] Figures 15A to 15C are illustrating an additional example of connecting the device to a delivery unit. The example illustrated in Figures 15A to 15C is similar to the examples described in relation to Figures 8 to 11. The connector mechanism 111 illustrated in Figure 15A has a distal end section 112 and a proximal end section 110. The distal end section is designed to be connected to the structure of an embolic protection device and the proximal end section is designed to be connected to a wire, tube or tape under the embolic protection device, see, for example, Figures 8B and 21B and 12C. The proximal end section 110 of the connector mechanism 111 forms a hollow cylindrical body that can slide over the wire, tube or tape 114 (in the illustrations, only a small portion of the wire, tube or tape is shown) until it is securely locked.
    [00121] The locking can be done by a first locking element 113 of the proximal end section of the connector mechanism 111 engaging with a second locking element 115 of the wire, tube or tape. The first locking element 113 can be a handle that is angled on the hollow cylindrical body and engages with a hole or window 115 of the wire. The hole or window can be the same width as the handle, preventing rotation of the connector mechanism 111 around the wire, tube or tape after the handle engages the hole or window.
    [00122] Alternatively, the second locking element 115 of the wire, tube or tape may be a handle that is angled outwards, so that it can engage with a first locking element 113 of the proximal end section 110 of the connector mechanism 111, being a hole or window. Again, the hole or window can be the same width as the handle to avoid
    Petition 870190101625, of 10/10/2019, p. 30/163
    26/27 the rotation of the embolic protection device.
    [00123] The distal end section 112 of the connector mechanism is formed by a portion of the connector mechanism 111 being folded back on itself, providing a gap 118 between them in which a structure of an embolic protection device, such as a wire , you can slide. The distal end of the distal end section 12 may have a greater gap 117. The greater gap 117 may be configured to have a diameter similar to the diameter of the structure of the embolic protection device.
    [00124] This arrangement allows the structure to be arranged firmly in the distal end section 112, while still providing axial articulation, but not radially, at the joint between the structure and the connector mechanism 111 when applying force to the embolic protection device.
    [00125] To lock the structure in the gap 118, 117 and prevent it from slipping, a locking ring 116 is slid over the retractable back of the distal end section 112. Locking ring 116 is locked having a section 119 of the folded back being wider than the hole through the locking ring. The widest section of the back-folded portion will be crimped when the locking ring 116 is slid and will thereafter expand, preventing the locking ring 116 from slipping. To increase the flexibility of the wide section of the back-folded part and thus allow it to expand more easily, a slot 119 can be arranged in the middle of the wider section.
    [00126] The connector mechanism 111 illustrated in Figure 15A, is designed to provide stability and flexibility and to allow a certain degree of freedom without rotation, which allows the wire, tube or tape to remain in the correct position while the embolic protection device is in the desired position.
    [00127] Although several examples of the present disclosure have been described and illustrated here, those skilled in the art will see
    Petition 870190101625, of 10/10/2019, p. 31/163
    27/27 readily a variety of other means and / or structures to perform the functions and / or obtain the results and / or one or more of the advantages described herein, and each of these variations and / or modifications is considered to be within the scope of present revelation. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials and configurations described herein must be exemplary and that the actual parameters, dimensions, materials and / or configurations will depend on the specific application or applications for which teachings of the present revelation are used. In addition, method steps other than those described above, executing the method by hardware, can be provided within the scope of the disclosure. The different characteristics and stages of the development can be combined in combinations other than those described. The scope of the disclosure is limited only by the attached patent claims.
    权利要求:
    Claims (15)
    [1]
    1. EMBOLIC PROTECTION DEVICE FOR VASCULAR DELIVERY TO AN AORTIC ARC OF A PATIENT, FOR PROTECTION OF SIDES OF THE SIDE BRANCH OF THE AORIC ARC AGAINST EMBOLIC MATERIAL, the said device being characterized by the fact that it includes:
    a support structure, wherein at least a distal or proximal portion of said support structure is a spring section configured to provide a radial force between said support structure and a wall of said aortic arch when in an expanded state;
    a filter member attached to said support structure and configured to prevent said embolic material from flowing with blood flow to said vessels in the lateral branch of said aortic arch.
    [2]
    2. DEVICE, according to claim 1, characterized by the fact that said support structure is a complete rim.
    [3]
    3. DEVICE according to either of claims 1 or 2, characterized in that the support structure is made up of at least four separate sections, including a distal and proximal spring section that is heat treated and at least two sections central.
    [4]
    DEVICE, according to any one of claims 1 to 3, characterized by the fact that said support structure includes at least two central sections that are straight.
    [5]
    5. DEVICE, according to any one of claims 1 to 4, characterized by the fact that said at least distal or proximal spring section is heat treated, while said at least two central sections are not heat treated.
    [6]
    6. DEVICE, according to any one of claims 1 to 5, characterized by the fact that said at least distal or proximal spring section includes at least one spring element, such as a ring, arranged around the center of each one of said spring sections at least distal or
    Petition 870190101625, of 10/10/2019, p. 33/163
    2/2 proximal, as in a proximal or distal end of said support structure, configured to increase said force of said spring sections.
    [7]
    7. DEVICE according to any one of claims 1 to 6, characterized in that said filter element has a dome shape.
    [8]
    8. DEVICE, according to claim 7, characterized by the fact that said dome-shaped filter element has a three-dimensional shape.
    [9]
    9. DEVICE according to any one of claims 1 to 8, characterized in that said support structure is made from a wire or is laser cut.
    [10]
    10. DEVICE, according to any one of claims 1 to 9, characterized by the fact that said support structure is thicker at least in said distal section or in said proximal section.
    [11]
    11. DEVICE according to any one of claims 1 to 10, characterized in that said transvascular delivery unit comprises a wire or tube.
    [12]
    12. DEVICE, according to claim 11, characterized by the fact that a connection point is arranged in a proximal portion of said filter element or said support structure.
    [13]
    13. DEVICE according to either of claims 11 or 12, characterized in that said wire or tube continues in a longitudinal direction under said support structure and said filter element towards a distal end of said device when disposed in the aortic arch.
    [14]
    14. DEVICE, according to claim 13, characterized by the fact that said wire or tube is bent after said connection to said connection point.
    [15]
    15. DEVICE according to any one of claims 11 to 14, characterized in that said wire or tube has a dilating tip at the distal end which is atraumatic.
    类似技术:
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    同族专利:
    公开号 | 公开日
    KR20200006075A|2020-01-17|
    US20190038392A1|2019-02-07|
    AU2018264573A1|2019-10-24|
    JP2019526303A|2019-09-19|
    JP2021072943A|2021-05-13|
    EP3589234A1|2020-01-08|
    CN109640880A|2019-04-16|
    EP3400901A1|2018-11-14|
    US11000357B2|2021-05-11|
    CA3061641A1|2018-11-15|
    US20210220110A1|2021-07-22|
    WO2018206160A1|2018-11-15|
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    法律状态:
    2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    EP17170949.6A|EP3400901A1|2017-05-12|2017-05-12|A device for filtering embolic material in a vascular system|
    PCT/EP2018/052953|WO2018206160A1|2017-05-12|2018-02-06|A device for filtering embolic material in a vascular system|
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