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    • 专利摘要:
    A braid for treating an aneurysm may include a first radially expandable segment operable to move from a retracted state within a microcatheter to an implanted distal state of the microcatheter. The first radially expandable segment may be capable of radially expanding to form an external occlusive sac in the aneurysm in the implanted state. The braid may also include a second radially expandable segment operable to move from the retracted state within the microcatheter to the distal implanted state of the microcatheter, and the second radially expandable segment is capable of radially expanding into the outer occlusive sac to form a sac internal occlusive in the external occlusive sac in the implanted state. an expansion mechanism may be included and arranged at a proximal end of the first and second radially expandable segments.
    公开号:BR102019001379A2
    申请号:R102019001379-6
    申请日:2019-01-23
    公开日:2019-08-06
    发明作者:Juan Lorenzo；Ariel Sotodelvalle；Lacey GOROCHOW
    申请人:DePuy Synthes Products, Inc.；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for DEVICE FOR ANEURISM AND IMPLEMENTATION SYSTEM.
    FIELD OF THE INVENTION [001] The present invention relates to medical instruments, and more particularly, to systems and devices for aneurysm therapy.
    BACKGROUND OF THE INVENTION [002] Aneurysms can be complicated and difficult to treat. For example, access to treatment may be limited or unavailable when an aneurysm is located close to critical tissues. Such factors are of particular concern with cranial aneurysms due to the brain tissue surrounding the cranial vessels that have corresponding limited access to treatment.
    [003] Previous solutions included access to endovascular treatment, so that an internal volume of the aneurysm sac is removed or excluded from the flow and arterial blood pressure. In this respect, due to the fact that the internal walls of the aneurysm can continue to be subjected to the flow of blood and related pressure, it is still possible to rupture the aneurysm.
    [004] Alternatives to endovascular or other approaches may include occlusive devices. These devices typically incorporate multiple embolization springs that are applied to the vasculature using microcatheter delivery systems. For example, when treating cranial aneurysms, a release catheter with embolization springs is typically first inserted into the non-cranial vasculature through a femoral artery in the hip or groin area. After that, the catheter is guided to a place of interest within the skull. The aneurysm sac can then be filled with embolic material to create a thrombotic mass that protects the arterial walls from blood flow and related pressure. Meantime,
    Petition 870190016798, of 02/19/2019, p. 4/53
    2/30 such occlusive devices have certain disadvantages, including mass effect, which can cause compression on the brain and its nerves.
    [005] A specific type of occlusive approach strives to apply and treat the entrance or neck of the aneurysm as opposed to the volume of the aneurysm. In such neck approaches, by minimizing blood flow through the neck, then a cessation of flow into the aneurysm can be achieved. In turn, a thrombotic mass can form naturally without having to supply embolic materials, as previously described. This is preferable to masses formed from embolic material, since a natural mass can improve healing by reducing possible distension of the arterial walls and allowing reintegration into the original shape of the vessel along the plane of the aneurysm neck. It is understood that the neck plane is an imaginary surface where the innermost layer of the original wall would be if the aneurysm did not exist. However, occlusive bottleneck approaches are not free from disadvantages. It is desired to block the neck of the aneurysm in the parental vessel. In addition, embolization springs do not always effectively treat aneurysms, as aneurysm recanalization and / or spring compression can occur over time.
    [006] Thus, it is desirable to have a device that easily, accurately and securely occludes a neck of an aneurysm or other arteriovenous malformation in a main vessel without blocking the flow to the perforating vessels that communicate with the original vessel. SUMMARY OF THE INVENTION [007] In some embodiments, the present description refers to a braid to treat an aneurysm. The braid may include a first radially expandable segment operable to move from a retracted state within a microcatheter to an implanted distal state of the microcatheter. The first radially expandable segment
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    3/30 may be able to expand radially to form an external occlusive sac in the aneurysm that seals the neck of the aneurysm in the implanted state. The braid can also include a second radially expandable and operable segment to move from the retracted state within the microcatheter to the implanted distal state of the microcatheter, the second radially expandable segment being able to expand radially within the external occlusive sac to form a sac internal occlusive in the external occlusive bag in the implanted state. An expansion mechanism may be included and arranged at a proximal end of the first and second radially expandable segment.
    [008] In some embodiments, the expansion mechanism may include an expansion ring with an opening. A distal end of the braid can be inserted through the opening, and then the proximal end can be folded over the opening.
    [009] In some embodiments, the expansion mechanism may include an opening and a plurality of radially flexible elements. Each flexible element may be able to expand from a retracted condition in the microcatheter to an expanded condition in the microcatheter's distal positioned state to support a proximal portion of the external occlusive sac. Each radially flexible element can be uniformly spaced radially around a central geometric axis of the expansion mechanism. The central geometric axis of the expansion mechanism can be axially aligned with a central geometric axis of the first and the second radially expandable segment.
    [0010] In some embodiments, the expansion mechanism may include at least four radially spaced flexible elements that extend from an expansion ring (for example a radially movable sheet capable of moving between retracted conditions)
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    4/30 of and implanted). However, the solution is not so limited, instead, more or less than four sheets can be included, as needed or required.
    [0011] In some embodiments, the expansion ring and the leaf or the leaves may be a monolithic structure. The expansion ring and the sheet or sheets can also be formed from a memory alloy material such as nitinol.
    [0012] In some embodiments, the expansion mechanism may include a plurality of expandable support elements that include potential energy stored in the retracted state (for example, the support elements may include polarized polarization elements or have memory formatting to expand in a predetermined way and release a predetermined amount of potential energy). The expandable support elements can be configured to drive the proximal end of the first radially expandable segment from the retracted state to the implanted state by releasing the potential energy from the expandable support elements.
    [0013] In some embodiments, a porosity of the internal occlusive sac may be greater than a porosity of the external occlusive sac.
    [0014] In some modalities, moving the braid distally after the external occlusive bag is formed causes an internal layer of the braid inside the external occlusive bag to expand radially inside the external occlusive bag and form the internal occlusive bag. The inner layer of the braid may also be able to expand radially within the outer occlusive sac, while the outer occlusive sac is pushed against the aneurysm wall and the neck of the aneurysm.
    [0015] In some modalities, a marker strip can be
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    5/30 included and in communication with the proximal end of the braid. The inner layer that expands radially inside the outer occlusive bag can be formed by folding the proximal end over the marker strip.
    [0016] In some modalities, in the implanted state, the braid is removable from a release system in the aneurysm.
    [0017] In some embodiments, the delivery system may include a microcatheter and a delivery tube. The distal end of the release tube can be removably connected to the proximal end of the braid. The delivery tube can be placed translucently inside the microcatheter. The release tube may also have the ability to transfer the braid distally within the microcatheter from the retracted to the implanted state.
    [0018] In some embodiments, the external occlusive bag may be a vaso-occlusive structure similar to a retractable cage.
    [0019] In some embodiments, the external occlusive bag may include fewer threads of thread than the internal occlusive bag.
    [0020] In some embodiments, the dimensions of the interstices of the braid vary at the proximal end in relation to the distal end, so that a porosity of the external occlusive sac is less than a porosity of the internal occlusive sac.
    [0021] In some modalities, the braid may be included in a system in communication with an imaging device capable of forming images of the external and / or internal occlusive bags in relation to the aneurysm. An orientation of the external and / or internal occlusive bags can be adjusted by moving the braid distally or proximally.
    [0022] In certain embodiments, an occlusive device is provided to treat an aneurysm. The device can include a braid being translucently placed inside a microcatheter of a state
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    6/30 retracted to an implanted state. Similarly, the braid can include a distal end and a proximal end. In the implanted state, the braid may include an external occlusive bag capable of exerting pressure against an aneurysm wall and sealing an aneurysm neck to deflect, deflect and / or delay a flow within the aneurysm, an internal occlusive bag disposed within the occlusive bag external and an expansion mechanism arranged at the proximal end to induce the formation of external and / or internal occlusive bags in the implanted state.
    [0023] In some modalities, a method for occluding an aneurysm is described. The method may include one or more of the following steps: positioning a radially expandable braid within a microcatheter, the braid being in a retracted state within the microcatheter and comprising a distal end and a proximal end; fix the proximal end of the braid to the distal end of a release tube; slide the braid distally from the microcatheter, through the release tube, towards the aneurysm; driving a first radially expandable segment of the braid to form an external occlusive sac by expanding a braid expansion mechanism, in which the expansion mechanism is attached to the proximal end of the braid; arrange the external occlusive sac along an aneurysm neck; and advancing the braid further distally, thereby increasing a second radially expandable segment within the braid into the external occlusive sac by distally pushing the external occlusive sac against the aneurysm wall and the aneurysm neck.
    [0024] In certain modalities, the method may include releasing the braid, including the external and internal occlusive bags, and removing the release tube and microcatheter from the aneurysm.
    [0025] In certain modalities, the expansion mechanism includes
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    7/30 a plurality of radially spaced flexible elements, each flexible element being able to expand from a retracted condition in the microcatheter to an expanded condition in the implanted state to support a proximal portion of the external occlusive bag. In this regard, the method may also include axially aligning the central geometric axis of the expansion mechanism with a central geometric axis of the first and the second radially expandable segment; and space each flexible element radially around the central geometric axis of the expansion mechanism.
    [0026] In some embodiments, the method may include providing an expansion ring with an opening over the expansion mechanism or with it; insert a distal end of the braid through the opening; and fold the proximal end of the braid over the opening.
    [0027] In some embodiments, the method may include spacing radially, around the expansion mechanism, at least four flexible elements extending from an expansion ring, each flexible element being a radially movable sheet capable of moving between the conditions retracted and implanted.
    [0028] In some embodiments, the method may include the formation of a monolithic structure of the expansion ring and at least four flexible elements.
    [0029] In some embodiments, the method may include the formation of a plurality of expandable support elements on the expansion mechanism comprising the potential energy stored in the retracted state; and propel, through the expandable support elements, the proximal end of the first radially expandable segment from the retracted state to the implanted state, by releasing the potential energy.
    [0030] In some modalities, the method may include forming the
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    8/30 the first radially expandable segment with a porosity less than that of the second radially expandable segment; positioning the first radially expandable segment adjacent or in communication with an aneurysm neck; and deflect, deflect and / or slow down a flow in the aneurysm.
    [0031] Other aspects and characteristics of this description will be evident to those versed in the technique, through the analysis of the detailed description below, together with the attached figures. BRIEF DESCRIPTION OF THE DRAWINGS [0032] Reference will now be made to the associated drawings, which are not necessarily drawn to scale.
    [0033] Figure 1A shows an occlusive device exemplifying this description in a retracted state;
    [0034] Figure 1B shows an occlusive device exemplifying this description in a retracted state within an example of a microcatheter;
    [0035] Figure 2A is a schematic side view of an exemplary delivery system with an occlusive device in an implanted state, but not released in the aneurysm;
    [0036] Figure 2B is a schematic bottom view of an exemplary expansion mechanism and the external occlusive bag of Figure 2A with the release system removed;
    [0037] Figure 3A is an enlarged schematic side view of the release system and the braid of Figures 1 to 2, as the occlusive device is being pushed into an example of aneurysm;
    [0038] Figure 3B is an enlarged schematic side view of the release system and the braid of Figures 1 to 2, as the occlusive device is being pushed into an example of aneurysm;
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    9/30 [0039] Figure 4A is an enlarged schematic side view of the release system and the braid of Figures 1 to 2, as the occlusive device is being pushed into an example of an aneurysm;
    [0040] Figure 4B is an enlarged schematic side view of the release system and the braid of Figures 1 to 2 after the occlusive device is implanted within an example of aneurysm;
    [0041] Figure 5A is a schematic perspective view showing an exemplary delivery system for use with an example occlusive device;
    [0042] Figure 5B is a schematic perspective view of Figure 5A, but with the partial cross section of the delivery system and the occlusive device;
    [0043] Figure 6A is a schematic perspective view of Figures 5A and 5B being implanted with the partial cross section of the delivery system and the occlusive device;
    [0044] Figure 6B is a schematic perspective view of Figures 5A and 5B implanted with the exemplary release system separate from the occlusive device.
    [0045] Figure 7 shows an example of this description implanted in an aneurysm example;
    [0046] Figure 8A shows an example of a prototype braid of this description without an example of an expansion mechanism;
    [0047] Figure 8B represents an example of a prototype braid of this description without an example of an expansion mechanism;
    [0048] Figure 8C represents an example of a prototype braid of this description without an example of an expansion mechanism;
    [0049] Figure 8D represents an example of a prototype braid of this description without an example of an expansion mechanism; and [0050] Figure 9 is a flow chart for a release method
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    10/30 of an occlusive device. DETAILED DESCRIPTION [0051] Although exemplary modalities of the described technology are explained in detail in the present invention, it should be understood that other modalities are contemplated. Therefore, it is not intended that the technology described be limited in scope to the details of construction and arrangement of components set out in the following description or illustrated in the drawings. The described technology is capable of other modalities and can be practiced or performed in several ways.
    [0052] It should also be noted that as used here and in the appended claims, the singular forms one, one, o and a include the respective plural forms, unless the context clearly determines otherwise. By comprising or containing or including it is understood that at least the mentioned compound, element, particle or method step is present in the composition, article or method, but does not exclude the presence of other compounds, materials, particles or steps method, even if the other such compounds, materials, particles or steps of the method have the same function as the named one.
    [0053] In the description of the exemplifying modalities, the terminology will be used for the sake of clarity. It should be understood that each term includes its broadest meaning, as understood by those skilled in the art, and includes all technical equivalents that operate in a similar way to accomplish a similar purpose. It should also be understood that the mention of one or more steps of a method does not exclude the presence of additional steps of the method or intermediate steps of the method between those steps expressly identified. The steps of a method can be performed in an order different from that described here without moving away
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    11/30 te and the scope of the technology presented. Similarly, it should also be understood that the mention of one or more components in a device or system does not exclude the presence of additional components or intermediate components between those components expressly identified.
    [0054] As discussed in this document, the vasculature can be that of any individual or patient, including any human or animal. It should be noted that an animal can be a variety of any applicable type, including, but not limited to, mammals, veterinary animals, pets or livestock, etc. For example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to those of a human being (for example, rat, dog, pig, monkey or the like). It should be noted that the individual can be, for example, any suitable human patient.
    [0055] As discussed in this document, an operator may include a doctor, surgeon or any other individual or application instrument associated with the application of a braided body to an individual's vasculature.
    [0056] Similarly, the flow diverters that are implanted along the neck of the aneurysm can alter the flow of blood into the aneurysm. An exemplary flow diverter can be a braided device with relatively low porosity. Over time, aneurysms can heal by sealing the neck of the aneurysm with a high success rate. However, flow diversion technology is not without limitations. Challenges include placing the devices intravascularly due to vessel morphology, the tortuosity of the vessel or the poor placement of the braid. In addition, patients who receive a flow diverter must undergo anticoagulation medications for an extended period
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    12/30 of the time, to avoid venous thrombosis. Intravascular devices also aim to cut off circulation in the aneurysm while minimizing the amount of metal in the vessel, and to cut significantly, or eliminate the need for coagulation medication. These types of devices may also be easier to track and / or implant at the injury site.
    [0057] The occlusive device 1 described in the present invention solves these and other disadvantages of the previous approaches by using a single device to seal the neck of the aneurysm. With reference to Figure 1A, an example of occlusive device 1 of this description is shown in a retracted state before being disposed with a microcatheter 20. Figure 1B represents the occlusive device of Figure 1A disposed in the retracted state within microcatheter 20. As shown , device 1 may include a braid 10 formed from self-expanding multifilamentous segments that can be formed from a mesh. For example, the braid 10 can include a first radially expandable segment 12 associated with an external occlusive bag and a second radially expandable segment 13 associated with an internal occlusive bag. The braid 10 can also have a distal end 14 associated with segment 12, a distal end 18 associated with segment 13, and a proximal end 16.
    [0058] An expansion mechanism 9 can also be included disposed at the proximal end 16 of the braid 10 or on top of it. The expansion mechanism 9 can include one or more flexible support elements 7 that extend from an expansion ring 5 with an opening 3 or are attached thereto. As shown, the flexible support elements 7 can be oriented to extend along the inner layer of the braid 10 in both the retracted and the implanted state. Each flexible support element 7 of the me
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    13/30 canism 9 can be lengthened and extend to one or more depths in the braid 10. Each element 7 of the mechanism 9 can facilitate the expansion of the braid 10 to form bags of segments 12 and / or 13, collectively with other flexible elements 7 or individually.
    [0059] The mesh of braid 10 can be defined by one or more mesh patterns, one or more distinct mesh portions and / or one or more mesh openings defined by the braided filaments. For example, the mesh of the braid 10 may include a region of porosity associated with an external occlusive bag formed by the braid 10 and another region of porosity associated with an internal occlusive bag configured to expand and / or overlap internally with the external occlusive bag. The internal occlusive bag may have a higher porosity than the external occlusive bag. For example, the braid mesh 10 shown in Figures 1A and 1B can include a region of different porosity associated with each of the segments 12 and 13.
    [0060] Each of the segments 12 and 13 can be radially expandable and capable of being disposed within the microcatheter 20 in a retracted state. Segment 12 can be an expandable outer wrap, while segment 13 can be an expandable inner wrap. Segment 12 can expand and only partially scrape off part of the aneurysm, as shown, and can form a cup shape that within segment 13 can form and expand. Each of segments 12 and 13 can be thermoformed in a spherical, saddle, ellipsoid or any other shape, as shown in Figures 1A to 2B. Although only segments 12 and 13 are shown, any number of segments could be included as needed or required. Each of segments 12 and 13 may be able to be moved from the retracted state to an implanted state.
    [0061] In practice, the porosity of segment 12 may allow
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    14/30 that the external occlusive sac of segment 12 assumes many shapes before, during or after release in aneurysm A. For example, the porosity of segment 12 may be relatively low to allow it to adapt flexibly to a plurality of aneurysms with different formats. Segment 12, in this regard, may have a lower porosity than the porosity of segment 13, based on different mesh opening sizes. The porosities associated with segments 12 and 13, and / or with any other region or segment of the braid 10, may also include a mesh with filaments that have a different shape and / or number of threads than the filaments in the other porosity regions.
    [0062] The mesh of braid 10 can be comprised of a tube that is closed at one end (for example, at the proximal end 16) and / or opened at the opposite distal ends 14 and 18. Braid 10 can be produced from various materials such as deposited thin films or a single material. The braid mesh 10 can include multiple threads, for example, from 4 to 96 threads. The number of threads can be a factor in controlling the material properties of braid 10, including porosity, shape in the implanted state, flexibility, stiffness and the like. The combination of one or more internally overlapping bags with an external occlusive bag can be taken into account in determining the number of threads of the braid 10 mesh, since one bag is inside the other. Additionally, the segment 12 external vascular occlusive bag and / or segment 13 internal occlusive bag can be a retractable cage like the vasoocclusive structure.
    [0063] The diameter of the braid 10 and the thread count of the braid can vary depending on the diameter of the device necessary to treat the aneurysm and / or the desired porosity. For example, the distal end 14 of segment 12 can be an open end
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    15/30 with a first diameter. The distal end 18 of segment 13 can be an open end with a second diameter that is less than the first diameter in the implanted state. The braid angle of the braid 10 can also be fixed or vary along the length of the braid 10 to create porosities along it. For example, to induce the formation of the predetermined shape and strength of the occlusive bags of segments 12 and 13, ends 14 and 18 may be more malleable than end 16, or vice versa, and other segments of braid 10 may vary from more malleable over or around end 14 and / or end 18 at least malleable over or around end 16. In some embodiments, ends 14 and 18 can be looped, as shown, which is particularly advantageous to ensure that the braid 10 is atraumatic when in contact with the dome of aneurysm A.
    [0064] The number of strands, the braiding angle, the patterns or the like, can be used to define the porosities of segments 12, 13. The strands of braid 10 can be produced from nitinol with platinum filaments interlaced for radiopacity , or filled nitinol drawn tube (DFT) with 10 to 40% platinum. The wires can be produced from a nickel-titanium alloy, cobalt-chromium alloys, stainless steel, tantalum and / or other alloys, and / or any other suitable biocompatible materials, or a combination of these materials. In addition, these materials may be absorbable or non-absorbable by the patient over time. In this respect, the first porosity associated with segment 12 may be less than the second porosity associated with segment 13. The arrangement of segments 12, 13 in the implanted state, the variation of the properties of the braid and / or the positioning of segment 12 in an adjacent position or communicating with an aneurysm bottleneck can induce a
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    16/30 flow fun effect. The material properties of segments 12, 13 may also differ in other respects, as needed or required, including heat treatment or coverage.
    [0065] The openings in the braid 10 mesh can also create a substantially unitary structure or mesh. In this way, the openings can be of any size, shape or porosity, and can be evenly or randomly spaced across the wall of the braid mesh 10. The openings can provide flexibility to the tubular element of the braid 10, and also help in transforming the mesh from the retracted state to the expanded state, implanted state and vice versa.
    [0066] As shown in Figures 1B to 2B, the release system 40 can include the microcatheter 20 with a release tube 30 slidably disposed within it. Microcatheter 20 can be pre-placed at the level of the aneurysm neck and used to track the device to the aneurysm. The size of the microcatheter 20 can be selected taking into account the size, shape and direction of the aneurysm or the parts through which the microcatheter 20 must pass to reach the treatment site. Microcatheter 20 can have a total useful length anywhere from 80 centimeters to 170 centimeters. Microcatheter 20 can have an ID internal diameter between approximately 0.038 and 0.081 centimeter (0.015 and 0.032 inch). The OD outer diameter may also vary in size and may decrease at its proximal or distal end. At its proximal end 26, microcatheter 20 can be attached to a surgical device, and at its distal end 24, it can be operable to be positioned on the neck of aneurysm A. While the distal end 24 of microcatheter 20, as shown, contains braid 10, end 24 can vary in shape and can bend at an angle.
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    17/30 [0067] The release tube 30 can be substantially elongated and can extend from the proximal end 26 to the distal end 24 of the microcatheter 20. The tube 30 can, in general, extend along the internal lumen of the microcatheter 20 and it can leave a space between its outer surface and the inner surface of the microcatheter 20. In turn, the release tube 30 and the microcatheter 30 can be axially aligned. System 40 can release a braid 10 at a site of interest (for example, at a site of injury) using microcatheter 20. In certain embodiments, microcatheter 20 can be pre-placed at a level of the aneurysm neck and used to tracking device 1 to the lesion, for example, by tracking marker strip 44 that may have radiopaque material. The release tube 30 may be in mechanical connection with the braid 10 in the locking portion 54. As shown more particularly below, the locking portion 54 may comprise or be a drive ring. The braid 10 can be fixed to the locking portion 54 by sliding fixation, permanent fixation (for example, crimped, laser, ultrasonic welding or other sources of heat, adhesive or the like) or other fixation approaches. When the release tube 30 is mechanically attached to the braid 10 in the lock portion 54, moving distally, sliding, or otherwise moving the tube 30 towards aneurysm A may cause the braid 10 to start moving from the condition retracted inside microcatheter 20 for its condition implanted externally to microcatheter 20 with segments 12 and 13.
    [0068] In the implanted state, part or all of the braid 10 is distal from the microcatheter 20, so that segments 12 and 13 can expand radially. The braid 10 is particularly advantageous since it is capable of being retracted within the microcatheter 20 and can also form multiple occlusive bags in the implanted state. The mesh of braid 10 can be configured with or without mechanism 9 so
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    18/30 that when the braid 10 is moved distally and its end 14 comes out of the microcatheter 20, the mechanism 9 can propel the segment 12 to expand radially so as to form an external occlusive bag of the first porosity. The external occlusive bag of segment 12 can be formed as the portions of the flexible support elements 7 of the mechanism 9 are distal from the end 24, and the end 14 of the braid 10 slides away from the end 24 of the microcatheter 20. When the elements flexible support brackets 7 of the mechanism 9 are no longer completely contained within the microcatheter 20, they can then release potential energy stored there and facilitate the formation of the occlusive bags of segments 12 and / or 13.
    [0069] As the braid 10 is additionally translated distally, the segment 13 can begin to expand radially inside the external occlusive bag of the segment 12. To expand radially inside the segment 12, the segment 13 can form an internal occlusive bag with a greater porosity than the porosity of segment 12. As shown in Figure 2A, the respective bags of segments 12 and 13 are now formed implanted and segment 13 is disposed internal to segment 12, but still connected to the release tube 30 through the portion of lock 54. In Figure 2A, the distal end 14 can form the outer layer of the outer occlusive bag of segment 12, while the proximal end 16 can form the outer layer of the inner occlusive bag of segment 13.
    [0070] Figure 2B is a schematic bottom view of an exemplary expansion mechanism 9 and the external occlusive bag of segment 12 in an implanted state and the release system 40 removed for clarity purposes only. As shown, the flexible elements 7 of the mechanism 9 can be spaced radially around a central geometric axis of the expansion mechanism, in
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    19/30 including a central geometric axis of the expansion ring 5 and / or opening 3. The expansion mechanism 9 may include a plurality of flexible expandable support elements 7 capable of propelling portions at the end 16 of the braid 10 or in a position adjacent to the same, from the retracted state in the microcatheter 20 to the implanted distal state of the microcatheter 20. Each element 7 of the mechanism 9 may include potential energy stored in the retracted state (for example, the support elements may include polarized polarization elements or have memory formatting) to expand in a predetermined way and release a predetermined amount of potential energy). The expandable support elements 7 of the mechanism 9 can be configured to drive the proximal end of the first radially expandable segment from the retracted state to the implanted state by releasing the potential energy from the expandable support elements 7.
    [0071] In certain embodiments, the expansion mechanism 9 may include at least four radially spaced flexible support elements 7 that extend from a central portion of the mechanism 9, such as the expansion ring 5. When retracted, the expansion mechanism expansion 9 can be sized to fit through the neck of the aneurysm. When expanded and released into the aneurysm, the expansion mechanism 9 can be larger and block the neck. As shown in Figure 2B one or more flexible support elements 7 of the mechanism 9 can be a radially movable sheet that can move between the retracted and implanted conditions. However, the mechanism 9 is not limited in this way and, instead, more or less than four sheets, or other elongated flexible support elements 7 of different structure, but similar function, can be included as needed or required. The expansion ring 5 and the leaf or leaves of the mechanism 9 can also be a structure
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    20/30 monolithic formed from a memory alloy material like nitinol. The central geometric axis of the expansion mechanism 9 can be axially aligned with a central geometric axis of the segments 12 and / or 13. The locking portion 54 can also be fixed to the mechanism 9 and / or aligned with it.
    [0072] As shown in Figure 1B and Figure 2B, the end 16 can be arranged on or adjacent to the marker strip in the adjacent position 44 and the lock portion 54. To form or assemble the braid 10 as shown in the Figures 1A to 2B, the end 15 and / or 18 of the braid 10 can be inserted through the opening 3 of the mechanism 9 and then the proximal end 16 of the braid 10 can be folded over the opening 3. In certain embodiments, the end 14 and / or 18 can be inserted through the marker strip 44 until the proximal end 16 is placed on or adjacent to the strip 44, in the locking portion 54. The locking portion 54 can then be connected and / or folded over end 16. Braid 10 is not limited in this way and, instead of being folded, proximal end 16 can be operatively connected to mechanism 9, lock portion 54 or any other component thereof by welding only mechanical fixation or adhesive. Regardless of the connection, the proximal end 16 operatively connected to the mechanism 7, the locking portion 54 and / or the band 44 can cause the formation of an outer layer of the braid 10 associated with the segment 12.
    [0073] In practice, as shown in Figures 3A to 4B, the braid 10 can be pushed into aneurysm A by the release tube 30 and be implanted with the outer porosity layer of segment 12 extending through the neck of the aneurysm A, and the inner layer of segment 13 can expand into the outer layer while pushing the outer layer in
    Petition 870190016798, of 02/19/2019, p. 23/53
    21/30 position against the aneurysm wall and / or the aneurysm neck. In particular, Figures 3A to 4B show an enlarged schematic side view of the release system 40 and the braid 10 as the braid 10 is being pushed into an example of aneurysm A. Before the arrangement of Figure 3A the braid 10 can be assembled with a release tube 30 and / or a microcatheter 20 in a retracted state and thus disposed within the release system 40. In this respect, the release system 40 and the braid 10 can be packaged as a kit or portable system. The assembly between the microcatheter 20, the release tube 30 and / or the braid 10 can occur before being introduced into the vasculature. The release system 40 used with the braid 10, which can include the microcatheter 20 and the release tube 30, can be selectively positioned at the injury site and the release tube 30 can begin to move the braid 10 distally towards the aneurysm.
    [0074] Returning to Figure 3A, the bag 12 has expanded radially towards the external walls of aneurysm A, while the unexpanded portions (for example, segment 13 and end 16) of the braid 10 continue to be translated by the release tube 30 The strand portions 10 distal to end 24 may expand as the strand 10 distances distally from end 24 of catheter 20. When it expands from the retracted state of Figure 1B to the intermediate implanted state of Figure 3A, segments 12 and 13 begin to expand radially from their respective occlusive sacs within aneurysm A. Mechanism 9 is also shown in Figure 3A in a retracted state completely contained within the microcatheter 20. Ring 5 of mechanism 9 is shown in communication with the end 16 while the portions of elements 7 extend around the segment 13 and in communication with the segment 12 on or around the end 16. In that the
    Petition 870190016798, of 02/19/2019, p. 24/53
    22/30 pecto, as the braid 10 moves distally, the segment 12 and / or the segment 13 can be driven by the elements 7 of the mechanism 9 to form the occlusive bags of this description.
    [0075] As shown in the transition state of Figure 3A, the segment 12 bag can be generically spherical in shape internal to aneurysm A while segment 13 remains predominantly retracted and stored inside the microcatheter 20. However, the portion of the distal segment 13 end 24 began to expand radially within segment 12.
    [0076] In Figure 3B, the release tube 30 slid the braid 10 distally further into aneurysm A so that the outer surface of segment 12 moved close to the contact dome D. The lock portion 54 is shown in position adjacent or close to end 24 of microcatheter 20 so that all portions of braid 10, including mechanism 9, are distal to it and external to microcatheter 20. As a result, elements 7 of mechanism 9 are shown to drive segment expansion 12 on or around the end 16 in order to expand radially and form the external occlusive bag shown in aneurysm A. It is understood that the outer surface of the braid 10 can be produced from nitinol with platinum filaments interlaced for radiopacity. The release tube 30 can be operated between Figures 3A and 3B by a hypodermic tube from its proximal end 36 by an operator or the like. The microcatheter 20 can remain relatively stationary or fixed while the release tube 30 can be seen distally translating the braid 10 towards and through the neck of aneurysm A.
    [0077] Braid 10 can include a transition or pre-weakened portion 19 (for example, shown in Figures 1A and 1B) so that when braid 10 and release tube 30 are distally
    Petition 870190016798, of 02/19/2019, p. 25/53
    23/30 transferred in the opposite direction to the microcatheter 20 and deeper into aneurysm A, elements 7 of the mechanism can propel segments 12 to expand and portion 19 can facilitate the initiation of radial expansion of segment 13 within segment 12. For For example, translating braid 10 over a first predetermined distance can cause segment 12 to expand radially to form its outer occlusive sac. Additionally, transferring the braid a second predetermined distance into an aneurysm A, as shown in Figure 3B, can cause the internal occlusive sac of segment 13 to form inside the external occlusive sac. In certain embodiments, the portion 19 shown in Figure 1 can initiate the radial expansion of segment 13 within segment 12.
    [0078] In Figure 4A, the release tube 30 is distally transferred more deeply into the aneurysm A. Moving between Figures 3A to 4A, it is shown that moving the braid 10 distally through the release tube 30, deeper into the aneurysm A can cause elements 7 of mechanism 9 to expand further and segment 12 to expand even more radially and press against the aneurysm wall. The additional distal translation can also cause the locking portion 54 to essentially increase the expansion angle of the segment 7 and the propulsion ring 5 of the mechanism 9 towards the aneurysm neck. In turn, the mechanism 9 is essentially inserted in the braid segment 13, thereby flattening or otherwise making the segment bag 12 more spherical. In certain embodiments, the widening of the segment 12 between Figures 3A and 4A may cause end 14 slides proximally back towards end 24 of the microcatheter, while segment 13 continues to expand radially.
    [0079] As seen also moving between Figures 3A to
    Petition 870190016798, of 02/19/2019, p. 26/53
    24/30
    4A, the junction between the end 16 of the braid 10, the lock portion 54, the mechanism 9 and the release tube 30 can move from the inside of the microcatheter 20 in the retracted state to completely inside the aneurysm A in the implanted state. Since braid 10, including segments 12 and 13, is selectively positioned and arranged for the desired condition (for example, braid 10 has been moved distally to expand segments 12 and 13 to form the inner and outer bags) , the braid 10 can be separated from the release tube 30, as shown in Figure 4B. In other words, as braid 10 is distally moved towards the dome of aneurysm A, segments 12 and 13 can expand and be used to expand radially in order to support the aneurysm wall in a way that is easy, efficient and avoid the risk of breakage.
    [0080] Once expanded and positioned, the release tube 30 can be moved proximally back into microcatheter 20 and retracted from braid 10 and aneurysm A. In particular, Figure 4B shows an example of braid 10 arrangement in its expanded state and the inner and outer bags of segments 13 and 12, respectively, completely formed with the release tube 30 having separated from the lock portion 54. Expanding segments 12 and 13 and positioning the mechanism 9 within the braid 10 is it is particularly advantageous since it can prevent the braid 10 from creating a bulge that would otherwise extend into the original vessel. Instead, any protuberance can now be folded into segment 12 and / or 13 of the braid 10. Arranging the braid 10 in this way through the neck of the aneurysm while also varying the porosity of the segments 12 and 13 can also create a flow deviation essentially inside the bags of braid 10. Figure 4B shows, simply, an example of spherical bags of segments 12 and 13
    Petition 870190016798, of 02/19/2019, p. 27/53
    25/30 fully formed in a sufficient way to occlude the aneurysm. However, if any of segments 12 and 13 are not precisely positioned or need to be reinitialized or adjusted within aneurysm A to provide a secure occlusion without risk of rupture, braid 10 can be retracted back into microcatheter 20 by withdrawal proximal to the release tube 30 while still attached to the braid 10.
    [0081] Figures 5A to 6B generically illustrate an example of fixation and release between the release tube 30 and the braid 10 to install and loosen the braid 10 in the aneurysm A. The modalities of Figures 5A to 6B are merely a shape with that the release tube 30 and the braid 10 can be fixed at the end 34, and any number of fixing means is contemplated as necessary or required. The release tube 30, as shown, can have a lumen extending from a proximal end 36 to a distal release end 34. Figure 5A illustrates the braid 10 engaged with the locking member 52 and the loop wire 58 locked in the locking portion 54. The opening 60 of the loop wire 58 can be placed through the locking portion 54. The locking portion 54 preferably takes the form of an elongated filament of small diameter; however, other shapes such as wires or tubular structures are also suitable. Although the locking portion 54 is preferably formed of nitinol, other metals and materials such as stainless steel, PTFE, nylon, ceramic or fiberglass and composites may also be suitable. The locking member 52, in one example, can be an elongated retractable fiber that can extend between the ends 24 and 26 of the microcatheter 20. The locking member 52 preferably takes the form of a small diameter elongated filament; however, other shapes such as wires or tubular structures are also suitable. Although the locking member
    Petition 870190016798, of 02/19/2019, p. 28/53
    26/30 ment 52 is preferably formed of nitinol, other metals and materials such as stainless steel, PTFE, nylon, ceramic or fiberglass and composites may also be suitable. When the locking member 52 is placed through the opening 60, the braid 10 is then secured. It is understood that the release tube 30 may include a compressible portion 38 disposed between its ends 34 and 36.
    [0082] The compressible portion 38 may allow the release tube 30 to flex and / or bend. Such flexibility can help to monitor braid 10 in microcatheter 20 and in the tortuous path through the vasculature. The compressible portion 38 can be formed with interference spiral cuts that can allow for gaps to allow for bending, but in one example, they do not act as a spiral cutting spring. The compressible portion 38 can be axially adjustable between an elongated condition and a compressed condition. However, any other arrangement that allows axial adjustment (for example, a coiled wire or spiral ribbon) may also be suitable for use with separation systems, in accordance with the present description). The compressible portion 38 can be in the stretched condition at rest and, automatically or resiliently, return to the stretched condition from a compressed condition, except where otherwise specified. The function of the compressible portion 38 is described in more detail in this document.
    [0083] A force F was previously applied to place the release tube 30 in a compressed state. Figure 5B illustrates the locking member 52 pulled proximally to initiate the release sequence for the braid 10. Figure 6A illustrates the instant when the locking member 52 leaves the opening 60 and is released from the loop wire 58. The end distal 62 of the loop wire 58 slips / returns to its preformed shape and leaves the locking portion 54. As can be seen, there is now nothing to attach braid 10 to the tube
    Petition 870190016798, of 02/19/2019, p. 29/53
    27/30 release 30. Figure 6B illustrates the end of the release sequence. Here, the compressible portion 38 of the release tube 30 has expanded / returned to its original shape and has been released forward. An elastic force E is imparted by the distal end 34 of the release tube 30 so that the braid 10 pushes it out to ensure a clean separation and the release of the braid 10 into the aneurysm A. It must be understood that the release scheme described in Figures 6A and 7B is merely an example of the approaches to release the braid 10.
    [0084] Figure 7 shows an example of braiding of this description implanted in an example of aneurysm A.
    [0085] Figures 8A to 8D show examples of braiding prototypes with various braiding properties. These prototypes are strictly for illustrative purposes.
    [0086] Figure 9 is a flow chart for a method 900 of releasing an occlusive device in the aneurysm. Step 905 includes positioning a radially expandable braid within the microcatheter, the braid being in a retracted state within the microcatheter and comprising a distal end and a proximal end. Step 910 includes fixing the proximal end of the braid to the distal end of the release tube. Step 915 includes sliding the braid distally from the microcatheter, through the release tube, towards the aneurysm. Step 920 includes pushing a first radially expandable segment of the braid to form an external occlusive bag by expanding a braiding mechanism that expands the expansion mechanism attached to the proximal end of the braid, the external occlusive bag being operable to extend along an aneurysm bottleneck. Step 925 includes advancing the braid further distally, thereby increasing a second radially expandable segment within the braid into the occlusive bag external to the em
    Petition 870190016798, of 02/19/2019, p. 30/53
    28/30 distally puncture the external occlusive sac against the aneurysm wall and the aneurysm neck. Step 930 includes releasing the braid, including the external and internal occlusive bags, and removing the delivery tube and microcatheter from the aneurysm. The external occlusive sac can form on or as the distal end of the braid moves distally from the microcatheter and in communication with an aneurysm dome.
    [0087] In certain embodiments of the 900 method, the expansion mechanism may include an opening and a plurality of radially flexible spaced elements, each flexible element being able to expand from a retracted condition in the microcatheter to an expanded condition in the implanted state supporting a proximal portion of the external occlusive sac. In this regard, method 900 may also include axially aligning the central geometric axis of the expansion mechanism with a central geometric axis of the first and the second radially expandable segment; and space each flexible element radially around the central geometric axis of the expansion mechanism.
    [0088] Method 900 may also include providing an expansion ring with an opening in the expansion mechanism or with it; insert a distal end of the braid through the opening; and fold the proximal end of the braid over the opening. Method 900 may also include at least four flexible elements radially spaced around the expansion mechanism extending from an expansion ring, each flexible element being a radially movable sheet capable of moving between retracted conditions and deployed. Method 900 may also include the formation of a monolithic structure of the expansion ring and the at least four flexible elements. Method 900 may also include the formation of a plurality of expandable support elements in the
    Petition 870190016798, of 02/19/2019, p. 31/53
    29/30 expansion mechanism comprising potential energy stored in the retracted state; and propel, through the expandable support elements, the proximal end of the first radially expandable segment from the retracted state to the implanted state, releasing potential energy. Method 900 may also include forming the first radially expandable segment with a porosity less than that of the second radially expandable segment; positioning the first radially expandable segment adjacent or in communication with an aneurysm neck; and inducing a fluid shift effect through the aneurysm neck when the inner sac is formed inside the outer occlusive sac.
    [0089] It is understood that variations of braid 10 can include various materials, such as stainless steel, bioabsorbable materials and polymers. Braid 10, including any specific portions such as any breaks, variable regions of different porosities and occlusive bags, can be thermoformed for various configurations, such as spherical, oblong, saddle-shaped or the like, for the purpose of shaping the outer bag and / or internal to better match the morphology of the aneurysm. In addition, the braid 10 can be thermoformed to include weaknesses to install the radial expansion of the occlusive bags. In addition, the interstices of the braid 10 forming the bags can vary, or be selectively designed, in size or shape along its length, depending on how much the braid 10 expands radially as the release tube 30 moves distally.
    [0090] It is understood that the braid 10 can also be included in a system or otherwise be in communication with an imaging device capable of imaging the external and / or internal occlusive bags of segments 12 and 13 in relation to the aneurysm. An orientation of the external and / or internal occlusive bag can be adjusted
    Petition 870190016798, of 02/19/2019, p. 32/53
    30/30 by braid 10 being distal or proximally moved in relation to the aneurysm and monitored precisely by the imaging device.
    [0091] The specific configurations, the choice of materials and the size and shape of various elements may vary according to the specifications or restrictions of a specific design that require a system or method built according to the principles of the described technology. Such modifications are intended to be included within the scope of the described technology. Therefore, the modalities described here are considered in all respects as illustrative and not restrictive. Therefore, it will be evident from the aforementioned that, although specific forms of the description have been illustrated and described, several modifications can be made without deviating from the character and scope of the description, and all changes understood in the meaning and scope of their equivalents are designed to be included in them.
    Petition 870190016798, of 02/19/2019, p. 33/53
    权利要求:
    Claims (20)
    [1]
    1. Braid to treat an aneurysm, characterized by the fact that the braid comprises:
    a first radially expandable and operable segment to move from a retracted state within a microcatheter to an implanted distal state of the microcatheter, where the first radially expandable segment is able to expand radially to form an external occlusive sac in the aneurysm that seals the aneurysm neck in the implanted state;
    a second radially expandable and operable segment to move from the retracted state inside the microcatheter to the implanted distal state of the microcatheter, the second radially expandable segment being able to expand radially inside the external occlusive sac to form an internal occlusive sac in the occlusive sac external in the implanted state; and an expansion mechanism disposed at a proximal end of the first and second radially expandable segments.
    [2]
    2. Braid according to claim 1, characterized by the fact that the expansion mechanism comprises an expansion ring with an opening, with a distal end of the braid being inserted through the opening and the proximal end is folded over the opening .
    [3]
    3. Braid according to claim 1, characterized by the fact that the expansion mechanism comprises an opening and a plurality of radially flexible elements, each flexible element being able to expand from a retracted condition in the microcatheter to an expanded condition in the implanted state to support a proximal portion of the external occlusive sac.
    [4]
    4. Braid, according to claim 3, characterized
    Petition 870190016798, of 02/19/2019, p. 34/53
    2/6 due to the fact that each flexible element is radially uniformly spaced around a central axis of the expansion mechanism, the central axis of the expansion mechanism being axially aligned with the central axis of the first and the second radially expandable segments.
    [5]
    5. Braid according to claim 3, characterized by the fact that the expansion mechanism comprises at least four radially spaced flexible elements that extend from an expansion ring, each flexible element being a radially movable sheet capable of to move between retracted and implanted conditions.
    [6]
    6. Braid according to claim 5, characterized by the fact that the expansion ring and the leaves are formed of a memory alloy material.
    [7]
    7. Braid according to claim 1, characterized by the fact that the expansion mechanism comprises a plurality of expandable support elements that comprise potential energy stored in the retracted state, the expandable support elements being configured to drive the end proximal of the first radially expandable segment from the retracted to the implanted state by releasing the potential energy from the expandable support elements.
    [8]
    8. Braid, according to claim 1, characterized by the fact that a porosity of the internal occlusive bag is greater than a porosity of the external occlusive bag.
    [9]
    9. Braid, according to claim 1, characterized by the fact that moving the braid distally after the external occlusive bag is formed causes an internal layer of the braid inside the external occlusive bag to expand radially inside the external occlusive bag and forms the internal occlusive bag.
    Petition 870190016798, of 02/19/2019, p. 35/53
    3/6
    [10]
    10. Braid according to claim 9, characterized by the fact that the inner layer of the braid is able to expand radially inside the external occlusive sac when the external occlusive sac is pushed against the aneurysm wall and the aneurysm neck.
    [11]
    11. Braid, according to claim 9, characterized by the fact that it also comprises a marker strip in communication with the proximal end of the braid, with the inner layer that expands radially inside the external occlusive bag being formed by folding the proximal end over the marker strip.
    [12]
    12. Braid, according to claim 1, characterized by the fact that, in the implanted state, the braid is removable from the implantation system in the aneurysm, with the implantation system comprising:
    a microcatheter; and a release tube comprising a distal end and a proximal end, the distal end of the release tube being removably connected to the proximal end of the braid, the release tube being implantable in a translatable manner within the microcatheter;
    the release tube being able to transfer the braid distally inside the microcatheter from the retracted state to the implanted state.
    [13]
    13. Braid according to claim 1, characterized by the fact that the dimensions of the interstices of the braid vary at the proximal end in relation to the distal end, so that the porosity of the external occlusive sac is less than that of the occlusive sac internal.
    [14]
    14. Occlusive device to treat an aneurysm, characterize
    Petition 870190016798, of 02/19/2019, p. 36/53
    4/6 by the fact that it comprises:
    a braid that can be translatable within a microcatheter from a retracted to an implanted state, wherein the braid comprises a distal end and a proximal end;
    being that, in the implanted state, the braid comprises:
    an external occlusive sac capable of exerting pressure against the wall of an aneurysm and sealing the neck of the aneurysm to at least one of the ones to deflect, deflect and slow down the flow into the aneurysm;
    an internal occlusive bag disposed within the external occlusive bag; and an expansion mechanism arranged at the proximal end, stimulating the formation of at least one of the external and internal occlusive bags in the implanted state.
    [15]
    15. Method for closing an aneurysm, characterized by the fact that it comprises:
    positioning a radially expandable braid within a microcatheter, the braid being in a retracted state within the microcatheter and comprising a distal end and a proximal end;
    fix the proximal end of the braid to the distal end of a release tube;
    slide the microcatheter braid distally through the release tube towards the aneurysm;
    driving a first radially expandable segment of the braid to form an external occlusive sac by expanding a braid expansion mechanism, in which the expansion mechanism is attached to the proximal end of the braid;
    arrange the external occlusive sac along an aneurysm neck; and
    Petition 870190016798, of 02/19/2019, p. 37/53
    5/6 further advance the braid further distal, thus increasing a second radially expandable segment within the braid into the external occlusive sac by distally pushing the external occlusive sac against the aneurysm wall and the aneurysm neck;
    [16]
    16. Braid according to claim 15, characterized by the fact that the expansion mechanism comprises a plurality of radially flexible elements, each flexible element being able to expand from a retracted condition in the microcatheter to an expanded condition in the implanted state of in order to support a proximal portion of the external occlusive sac, the method also comprising:
    axially align the central geometric axis of the expansion mechanism with a central geometric axis of the first and second radially expandable segments; and space each flexible element radially around the central geometric axis of the expansion mechanism.
    [17]
    17. Method, according to claim 15, the method being characterized by the fact that it also comprises:
    provide an expansion ring with an opening on or with the expansion mechanism;
    insert a distal end of the braid through the opening; and fold the proximal end of the braid over the opening.
    [18]
    18. Method, according to claim 15, characterized by the fact that it also comprises:
    space radially, around an expansion mechanism, at least four flexible elements extending from an expansion ring, each flexible element being a radially movable sheet capable of moving between retracted and
    Petition 870190016798, of 02/19/2019, p. 38/53
    6/6 implanted.
    [19]
    19. Method, according to claim 15, characterized by the fact that it also comprises:
    forming a plurality of expandable support elements on the expansion mechanism comprising potential energy stored in the retracted state; and propel, through the expandable support elements, the proximal end of the first radially expandable segment from the retracted state to the implanted state, by releasing the potential energy.
    [20]
    20. Method, according to claim 15, characterized by the fact that it also comprises:
    forming the first radially expandable segment with less porosity than a porosity of the second radially expandable segment;
    positioning the first radially expandable segment adjacent or in communication with an aneurysm neck; and at least one of the deflection, divergence and deceleration of a flow in the aneurysm.
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    同族专利:
    公开号 | 公开日
    JP2019126734A|2019-08-01|
    CA3031096A1|2019-07-24|
    CN110063765A|2019-07-30|
    US20190223878A1|2019-07-25|
    US10905430B2|2021-02-02|
    EP3517055A1|2019-07-31|
    US20200397447A1|2020-12-24|
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    法律状态:
    2019-08-06| B03A| Publication of an application: publication of a patent application or of a certificate of addition of invention|
    优先权:
    申请号 | 申请日 | 专利标题
    US15/879,196|2018-01-24|
    US15/879,196|US10905430B2|2018-01-24|2018-01-24|Aneurysm device and delivery system|
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