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    • 专利摘要:
    aneurysm release device and system. The present disclosure relates to a braid for treating 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 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 within the outer occlusive sac to form an occlusive sac. in the external occlusive sac in the implanted state.
    公开号:BR102018076824A2
    申请号:R102018076824-7
    申请日:2018-12-21
    公开日:2019-07-09
    发明作者:Juan Lorenzo
    申请人:DePuy Synthes Products, Inc.；
    IPC主号:
    专利说明:

    Invention Patent Descriptive Report for ANEURISM DEVICE AND RELEASE SYSTEM. FIELD OF THE INVENTION [001] The present invention relates to medical instruments, and more particularly, to delivery systems for treating aneurysms. 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. These factors are of concern with cranial aneurysms due to the limited treatment access corresponding to the brain tissue that surrounds the cranial vessels.
    [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. However, these occlusive devices have certain disadvantages, including the fact that the volume they
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    2/31 they can fill is somewhat permanent due to the thrombotic mass released in it.
    [005] A specific type of occlusive approach is intended to provide and treat the entrance or neck of the aneurysm rather than the volume of the aneurysm. In such cervical approaches, aneurysm venostasis can be performed by minimizing blood flow through the neck. 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 typical for occlusive neck approaches to fail to prevent flow into blood vessels during aneurysm neck block in the original vessel. This can cause unintentionally serious damage if the vessel openings are blocked. 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 respects, the present disclosure relates to a braid to treat an aneurysm. The braid can include a lumen
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    3/31 with a distal end opposite to a proximal end. [008] In one embodiment, an occlusive device for treating an aneurysm is revealed. The device can include a braid that can be placed inside a microcatheter translatable from a retracted state 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 pressing against an aneurysm wall. In the implanted state, the braid may also include an internal occlusive bag disposed within and / or internally superimposed with the external occlusive bag.
    [009] In some embodiments, a porosity of the internal occlusive bag may be greater than a porosity of the external occlusive bag.
    [0010] In some modalities, in the implanted state, the external occlusive sac is able to seal against the neck of the aneurysm.
    [0011] 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 be able to expand radially within the outer occlusive sac, while the outer occlusive sac is pushed against the aneurysm wall and the aneurysm neck. In some embodiments, a marker strip may be 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.
    [0012] In some modalities, in the implanted state, the braid is removable from a release system in the aneurysm. The delivery system can include a microcatheter and a delivery tube with a
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    4/31 distal end and a proximal end. The distal end of the release tube can be removably connected to the proximal end of the braid. In this sense, the delivery tube can be placed translatably inside the microcatheter. The release tube may be able to transfer the braid distally within the microcatheter from the retracted to the implanted state.
    [0013] In some embodiments, the external occlusive sac is a vaso-occlusive structure similar to a retractable cage.
    [0014] In some embodiments, the external occlusive bag may have fewer thread segments than the internal occlusive bag.
    [0015] In some modalities, the device may be 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 and / or compaction density of the external and / or internal occlusive bags can be adjustable by moving the braid close or far.
    [0016] In some modalities, a braid is revealed 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 may be able to expand radially to form an external occlusive sac in the aneurysm in the implanted state that can be sealed against an aneurysm neck. The braid may also include a second radially expandable segment operable to move from the retracted state within the microcatheter to the implanted distal state of the microcatheter. The second radially expandable segment may be able to expand radially within the external occlusive bag to form an internal occlusive bag in the external occlusive bag in the implanted state.
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    5/31 [0017] In some modalities, the braid is removably implanted by an aneurysm release system.
    [0018] In some embodiments, the braid may also include a portion of the buckle arranged between the first and second segments radially expandable, with the portion of the buckle allowing the inner occlusive bag to be formed inside, covered with and / or expand ( for example, radially) in the external occlusive sac when positioned through the neck of the aneurysm.
    [0019] In some embodiments, 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 internal occlusive sac.
    [0020] In some modalities, a method of occluding an aneurysm is revealed. The method may include placing a radially expandable braid within the vasculature of the aneurysm; forming a first radially expandable segment of the strand with less porosity than a porosity of a second radially expandable segment; push the braid distally into the aneurysm, whereby the first radially expandable segment expands radially to form an external occlusive sac; push the strand more distally, thus expanding the second radially expandable segment within the external occlusive bag; positioning the first radially expandable segment adjacent or in communication with an aneurysm neck; deflect, deflect or slow the flow to the aneurysm through the neck of the aneurysm when the external occlusive sac is formed through the neck and the internal occlusive section is formed therein.
    [0021] In some modalities, a method is revealed to release an occlusive device for an aneurysm. The method includes sliding a release tube into a microcatheter;
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    6/31 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; fix the proximal end of the braid to the distal end of the release tube; selectively position the microcatheter, the release tube and the braid in the vasculature of the aneurysm; slide the microcatheter braid distally through the release tube towards the aneurysm; push the strand distally through the release tube into the aneurysm so that a first radially expandable segment of the strand expands radially to form an external occlusive bag, the external occlusive bag being operable to extend through an aneurysm neck ; advancing the strand distally thereby increasing a second radially expandable segment of the strand into the external occlusive sac by distally pushing the external occlusive sac against the aneurysm wall and the aneurysm neck; and release the braid, including the external and internal occlusive bags, and remove the release tube and microcatheter from the aneurysm.
    [0022] In some embodiments, the method also includes 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 deflect, deflect or slow the flow to the aneurysm through the neck of the aneurysm when the external occlusive sac is formed through the neck and the internal occlusive section is formed therein.
    [0023] In some embodiments, the inner occlusive bag comprises an inner layer of the braid. External and internal occlusive bags, when formed in certain modalities, include a predetermined packing density range.
    [0024] In some modalities, the method includes imagining the bag
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    7/31 external occlusive and / or the internal occlusive sac in relation to the aneurysm; determine whether the aneurysm is occluded by the external occlusive sac and / or the internal occlusive sac; and sliding, distally or proximally, the braid to adjust the external occlusive bag and / or the internal occlusive bag to occlude the aneurysm.
    [0025] Other aspects and characteristics of the present disclosure 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 [0026] Reference will now be made to the associated drawings, which are not necessarily drawn to scale.
    [0027] Figure 1A represents an example of an occlusive device of this description in a retracted state.
    [0028] Figure 1B represents an example of an occlusive device of this description in a retracted state within an exemplary microcatheter.
    [0029] Figure 2 represents an example of an occlusive device of this description, in which the braid is being implanted.
    [0030] Figure 3 is a schematic side view of an exemplary delivery system with an occlusive device in an implanted state.
    [0031] Figure 4A is an enlarged schematic side view of the release system and the braid of Figures 1 to 3, as the occlusive device is being pushed into an exemplary aneurysm;
    [0032] Figure 4B is an enlarged schematic side view of the release system and the braid of Figures 1 to 3, as the occlusive device is being pushed into an exemplary aneurysm;
    [0033] Figure 5A is an enlarged schematic side view of the
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    8/31 release and braiding system of Figures 1 to 3, as the occlusive device is being pushed into an exemplary aneurysm;
    [0034] Figure 5B is an enlarged schematic side view of the release system and the braid of Figures 1 to 3 after the occlusive device is implanted within an exemplifying aneurysm;
    [0035] Figure 6A is a schematic perspective view showing an exemplary delivery system for use with an exemplary occlusive device;
    [0036] Figure 6B is a schematic perspective view of Figure 6A, but with the partial cross section of the delivery system and the occlusive device;
    [0037] Figure 7A is a schematic perspective view of Figures 6A - 6B being installed with the partial cross section of the release system and the occlusive device;
    [0038] Figure 7B is a schematic perspective view of Figures 6A - 6B implanted with the exemplary release system separate from the occlusive device;
    [0039] Figure 8A is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0040] Figure 8B is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0041] Figure 8C is an enlarged view of a step of an exemplary delivery system device being deployed in
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    9/31 an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0042] Figure 8D is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0043] Figure 8E is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0044] Figure 8F is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0045] Figure 8G is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0046] Figure 8H is an enlarged view of a step of an exemplary delivery system device being implanted in an aneurysm according to this disclosure, in which the system is shown moving from a flattened condition to an implanted condition;
    [0047] Figure 9 shows a braided example of this revelation implanted in an exemplifying aneurysm;
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    10/31 [0048] Figure 10A shows a braided prototype exemplifying this revelation;
    [0049] Figure 10B shows a prototype of braided example of this revelation;
    [0050] Figure 10C shows a prototype of braided example of this revelation;
    [0051] Figure 10D shows a prototype of a braided example of this revelation;
    [0052] Figure 11 is a flow chart for a method of releasing an occlusive device;
    [0053] Figure 12 is a flow chart for a method of releasing an occlusive device.
    DETAILED DESCRIPTION [0054] Although exemplary modalities of the disclosed 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 disclosed technology 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 technology revealed is capable of other modalities and can be practiced or performed in several ways.
    [0055] 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
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    11/31 have the same function as the nominee.
    [0056] In the description of the exemplifying modalities, the terminology will be used for the sake of clarity. It should be understood that each term contemplates 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 a different order than described here without departing from 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.
    [0057] 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.
    [0058] 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.
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    12/31 [0059] It is known that cerebrovascular aneurysms are treated using embolic coils, which are released into the aneurysmal sac through a microcatheter and separated locally. It is understood that compaction density is the volume of the aneurysmal sac occupied by the mass of the coil. In previous coil approaches, multiple coils (for example, five coils) were used to package the aneurysms, and the packing density can typically vary between 20 and 25%. The device disclosed in the present invention improves on previous approaches as it is operable to seal the neck of the aneurysm and package the aneurysm at a higher packing density, avoiding the risk of rupture of the aneurysm during packaging.
    [0060] In previous embolization approaches, packing the aneurysm required placing coils in the aneurysm sac until the aneurysm achieved the desired packing density to occlude the aneurysm. However, obtaining such density without risk of rupture was difficult and unsafe, and the morphology of the aneurysm (for example, wide neck, bifurcation, etc.), and the like, made it difficult, if not impossible, for an operator to reposition the coils, a once released and installed on site. In addition, aneurysms treated with multiple coils are often reanalyzed or compressed as a result of improper winding, lack of coverage through the aneurysm neck, as a result of the flow, or even by the size of the aneurysm.
    [0061] 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,
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    13/31 flow deviation is not without limitations. Challenges include the placement of devices intravascularly due to vessel morphology, the tortuosity of the vessel or the poor positioning of the braid. In addition, patients who receive a flow diverter must undergo anticoagulation medicine for an extended period of time to avoid venous thrombosis. Intrasaccular devices also aim to cut off circulation in the aneurysm while minimizing the amount of metal in the vessel and cutting significantly, or eliminating the need to medicate coagulation. These types of devices may also be easier to track and / or implant at the injury site.
    [0062] The occlusive device 1 disclosed in the present invention addresses these and other disadvantages of the previous approaches. Returning to Figure 1A, an example of occlusive device 1 of this description is shown in a retracted state before being placed with a microcatheter 20. Figure 1B shows 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. 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. Each end 14 and 18 can be opened.
    [0063] 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, mesh 10 can include a region of porosity
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    14/31 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 to 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 segments 12 and 13. Each of segments 12 and 13 can be radially expandable and capable of being placed inside the microcatheter 20 in a retracted state. Segment 12 can be an expandable outer wrap, while segment 13 can be an expandable inner wrap. Each of segments 12 and 13 can be thermoformed in a spherical, saddle, ellipsoid or any other shape, as shown in Figures 1 and 2. Although only segments 12 and 13 are shown, any number of segments and corresponding bags could be included as needed or required. Each of segments 12 and 13 may be able to be moved from the retracted state to the implanted state. [0064] In practice, the porosity of segment 12 can allow segment 12 to assume many shapes before, during or after application to 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 shapes. Segment 12 may have a lower porosity than the porosity of segment 13, based on different opening sizes. The porosities associated with segments 12 and 13, and / or with any other region or segment of the braid 10, can also include filaments that have a different shape and / or number of threads than the filaments in the other porosity regions.
    [0065] The mesh of braid 10 can be comprised of a tube that is closed at one end (for example, at the end
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    Proximal 15/31 16) and / or open at distal ends 14 and 18, and can be made of various materials, such as thin films deposited. The mesh of braid 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 the 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 strands of the braid 10 mesh, since one bag is inside the other. Fewer strands of braid 10 can be used as a whole and still result in a high packing density when combined.
    [0066] The diameter of the braid 10 and the thread count of the braid may vary depending on the diameter of the device needed to treat the aneurysm and / or the desired porosity. For example, the distal end 14 of the segment 12 can be an open end 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 or facilitate 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 strand 10 may vary from the most malleable on or around end 14 and / or end 18 to the least malleable on or around end 16. In some embodiments, ends 14 and 18 can be looped, as shown, which is particularly advantageous to ensure that braid 10 is not traumatic when in contact with the dome of the
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    16/31 aneurysm A.
    [0067] 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, varying the properties of the strand, and / or the positioning segment 12 adjacent or in Communication with an aneurysm neck can facilitate inversion and / or deflect, deflect or slow the flow in the aneurysm. The material properties of segments 12, 13 may also differ in other respects, as needed or required, including heat treatment or coverage.
    [0068] The openings in the braid 10 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 with flexibility, and also help in the transformation from the compacted state to the expanded state, and vice versa.
    [0069] As shown in Figure 1B and Figure 2, the delivery system 40 can include the microcatheter 20 with a release tube 30 slidably disposed within it. The microcatheter 20
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    17/31 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 inner diameter of between approximately 0.038 and 0.081 centimeter (0.015 and 0.025 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 the braid 10, the end 24 can vary in shape and can bend at a certain angle.
    [0070] 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. Tube 30 can, in general, extend along the inner lumen of the microcatheter 20 and 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 on the neck of the aneurysm and used to tracking device 1 to the lesion, for example by tracking marker strip 44. Release tube 30 may be in mechanical connection with braid 10 in locking portion 54. As shown more particularly below, locking portion 54 may comprise or be a ring
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    18/31 propellant. 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 strand 10 in the locking portion 54, translating, sliding or otherwise moving the tube 30 distally towards aneurysm A, this can cause the strand 10 to start moving from the retracted state inside the microcatheter 20 to its implanted state external to the microcatheter 20 with segments 12 and 13.
    [0071] In the implanted state, part or all of the strand 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 into the microcatheter 20 while also being able to form multiple occlusive bags in the implanted state. The mesh of the braid 10 can be configured so that when the braid 10 is transferred distally and its end 14 comes out from inside the microcatheter 20, the segment 12 can expand radially to form an external occlusive bag of the first porosity. The external occlusive bag can be formed as the end 14 slides away from the end 24 of the microcatheter 20.
    [0072] As the braid 10 is additionally translated distally, the segment 13 can begin to expand radially internal to the external occlusive bag of segment 12. Through the radial expansion inside the segment 12, segment 13 can form an internal occlusive bag with greater porosity than the porosity of segment 12, as shown in Figure 2, so that the respective bags of segments 12 and 13 are shown formed in an implanted state, with segment 13 being internal to the segment
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    19/31
    12, but still connected to the release tube 30 through the locking portion 54. In Figure 2, 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 bag internal occlusive of segment 13.
    [0073] As shown in Figure 1B and Figure 2, the end 16 can be arranged over or adjacent to the adjacent marker strip 44 and the locking portion 54. The end 14 can be inserted through the marker strip 44 until the proximal end 16 is placed over or adjacent to strip 44 in locking portion 54. Locking portion 54 can then be connected and / or folded over end 16. Braid 10 is not so limited and, instead of being bent, the proximal end 16 can be operatively connected to the locking portion 54 by sonic welding, mechanical fixing or adhesive. Regardless of the connection, the proximal end 16 operatively connected to the locking portion 54 can cause the formation of an outer layer of the braid 10. When being disposed and assembled with the microcatheter 20 and a release tube 30, the device 1 can be released to the injury site.
    [0074] Returning to Figure 3, an enlarged schematic side view of the braid 10 of Figures 1 and 2 is shown in an expanded and enlarged state, but not released in an aneurysm. As shown, each of the segments 12 and 13 can have a segment with a generally spherical shape associated with their respective occlusive bags. Although the segment 12 of figure 3 shows that the portions on and / or in communication with the marker strip 44 can be mirrored ellipsoids.
    [0075] In practice, as shown in Figures 4A to 5B, the braid 10 can be pushed into aneurysm A by the release tube 30 and be implanted with the external porosity layer
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    20/31 lower segment 13 extending through the neck of aneurysm A, and the inner layer of segment 12 can expand into the outer layer while pushing the outer layer into position against the aneurysm wall and the aneurysm neck. In particular, Figures 4A to 5B represent an enlarged schematic side view of the release system 40 and strand 10 as strand 10 is being pushed into an exemplary aneurysm A. The outside diameter of segments 12 and 13 can be expand radially to a diameter greater than that of microcatheter 20. Prior to the arrangement of Figure 4A, braid 10 can be assembled with a release tube 30 and / or a microcatheter 20 in a retracted state. In this regard, the release system 40 and the strand 10 can be packaged as a kit or portable system. The set 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.
    [0076] Returning to Figure 4A, the bag 12 has expanded radially towards the external walls of aneurysm A, while the unexpanded proximal portions of its braid 10 continue to be translated by the release tube 30. The braid 10 can expand to As it moves distally from the end 24 of catheter 20 or over its end 14 in contact with aneurysm A. As it expands from the retracted state to the state in Figure 4A, segment 12 can expand radially to form the external occlusive sac within aneurysm A. As shown in Figure 4A, segment 12 may have an internal shape generally spherical to aneurysm A, while segment 13, in turn, remains predominantly retracted and
    Petition 870190016273, of 02/18/2019, p. 23/56
    21/31 stored inside the microcatheter 20. However, the portion of the distal segment 13 of the microcatheter 20 on or around its end 18 began to expand radially. The delivery tube 30 may include one or more operable fasteners to securely hold the strand 10 in place prior to implantation.
    [0077] In Figure 4B, the release tube 30 has a distally sliding braid 10 deeper into aneurysm A, so that the outer surface of segment 12 has moved closer to the dome D. Marker strip 44 has been distally translated further close and inserted in the neck of the aneurysm A. It is understood that the outer surface of the braid 10 can be produced from nitinol with interwoven platinum filaments to provide radiopacity. The release tube 30 can be driven by a hypotube from its proximal end 36 (not shown) by an operator or the like. The microcatheter 20 can remain relatively stationary or fixed, while the release tube 30 can be seen as the distally twisted strand 10 towards and through the aneurysm neck A. Strand 10 can include a transition or pre-weakened portion 19 (for example , shown in Figures 1A - 1B), so that when the braid 10 and the distribution tube 30 are distally moved away from the microcatheter 20 and deeper into aneurysm A, segments 12 can also translate, causing radial expansion and the formation of their respective occlusive bags. In certain embodiments, the portion 19 shown in Figure 1 can initiate the radial expansion of segment 13 within segment 12. For example, the translation of braid 10 over a first predetermined distance can cause segment 12 to expand radially to form the your external occlusive bag. Additionally, transfer the braid a second predetermined distance into an aneurysm A, as shown
    Petition 870190016273, of 02/18/2019, p. 24/56
    22/31 in Figure 4B, can cause the internal occlusive bag of segment 13 to form inside the external occlusive bag.
    [0078] In Figure 5A, the release tube 30 is distally transferred more deeply into the aneurysm A. Moving between Figures 4A to 5A, it is shown that moving the braid 10 distally through the release tube 30, deeper into the aneurysm A, can cause segment 12 to expand even more radially. Additional distal translation can also cause band 44 to be inserted further into strand 10, including segments 12 and 13, which can cause the proximal portion of segment 12 adjacent or in communication with the neck of the aneurysm to become more spherical. In certain embodiments, widening the segment 12 between Figures 4A and 5A may cause the end 14 to slide proximally back towards the end 24 of the microcatheter, while the segment 13 continues to expand radially. For example, as end 14 of segment 12 expands to a larger diameter between Figures 4A and 5A, end 14 can also be pulled proximally from end 18 and further expand outward while end 18 can remain on or adjacent to the dome of the aneurysm.
    [0079] As also seen in motion between Figures 4A to 5A, the junction between the end 16 of the braid 10, the locking portion 54 and the release tube 30 can move from inside the microcatheter 20 in the retracted state to completely inside aneurysm A in the implanted state. Since the braid 10, which includes segments 12 and 13, is selectively positioned and arranged according to the desired condition (for example, braid 10 has been moved distally to expand segments 12, 13 to form the outer and inner bags and / or braid 10 has expanded to a
    Petition 870190016273, of 02/18/2019, p. 25/56
    23/31 predetermined packing density), the external occlusive bag of segment 12 can be seen being sealed against the neck of the aneurysm, with its porosity lower than the porosity of segment 13 to deflect, deflect or decrease the flow into the aneurysm. At that point, the braid 10 can be separated from the release tube 30, as shown in Figure 5B. In other words, as the strand 10 is distally transferred towards the dome of aneurysm A, segments 12, 13 can expand and be used to support the aneurysm wall in a way that is easy, efficient and avoids the risk of rupture. (for example, see also Figures 8G and 8H).
    [0080] Once expanded and positioned, release tube 30 can be moved proximally back into microcatheter 20 and retracted from strand 10 and aneurysm A. Figure 5B shows an exemplary arrangement of strand 10 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 locking portion 54. Figure 5B shows, simply, exemplary spherical bags of segments 12, 13 fully formed in a manner enough to occlude the aneurysm. However, if any of segments 12, 13 is not precisely positioned or needs to be reinitialized or adjusted within aneurysm A to provide safe occlusion without risk of rupture, braid 10 can be retracted back into microcatheter 20 by proximally removing the release tube 30 while still attached to strand 10.
    [0081] In Figure 5B, since the bags of segments 12 and 13 were selectively positioned and formed inside aneurysm A, braid 10 was separated from release tube 30, and release tube 30 and microcatheter 20 can then be retracted from aneurysm A and
    Petition 870190016273, of 02/18/2019, p. 26/56
    24/31 injury site. The marker strip 44 and the locking portion 54 are also translated distally, so as to be positioned on or adjacent to the neck of the aneurysm A. The expanding segments 12, 13 and the folding band 54 in the braid 10 are particularly advantageous, a since the braid 10 can be prevented from creating a protuberance that would otherwise extend into the original container. Instead, any such protuberance can now be folded into segment 12. Laying strand 10 in this way through the neck of the aneurysm while also varying the porosity of segments 12, 13 can create a flow deviation essentially within the braided bags 10.
    [0082] Figures 6A to 7B generally illustrate an exemplary fixation and release between release tube 30 and strand 10 to install and release strand 10 in aneurysm A. The modalities of Figures 6A to 7B are merely a way that the tube release 30 and strand 10 can be attached to end 34, and any number of securing means is contemplated as needed 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 6A illustrates the braid 10 engaged with the locking element 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 a small diameter elongated filament; 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. Locking member 52, in one example, can be an elongated retractable fiber that can extend between
    Petition 870190016273, of 02/18/2019, p. 27/56
    25/31 the ends 24 and 26 of the microcatheter 20. The locking member 52 preferably takes the form of an elongated filament of small diameter; however, other shapes such as wires or tubular structures are also suitable. Although locking member 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.
    [0083] The compressible portion 38 may allow the release tube 30 to flex and / or bend. Such flexibility can help to monitor the braid 10 in the microcatheter 20 and in the tortuous trajectory through the vasculature. The compressible portion 38 can be formed with interference spiral cuts which may allow for gaps to allow 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 disclosure). 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.
    [0084] As shown in Figure 6A, force F was previously applied to place the release tube 30 in a compressed state. Figure 6B illustrates locking member 52 pulled proximally to initiate the release sequence for stranding 10. Figure 7A illustrates
    Petition 870190016273, of 02/18/2019, p. 28/56
    26/31 the moment when the locking element 52 leaves the opening 60 and is pulled free of the loop wire 58. The distal end 62 of the loop wire 58 vanishes / returns to its preformed shape and leaves the portion locking mechanism 54. As can be seen, there is now nothing to attach the braid 10 to the release tube 30. Figure 7 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 application tube 30 so that the braid 10 pushes it into shape to ensure a clean separation and the release of braid 10 into the aneurysm A. It must be understood that the release scheme described in Figures 6A and 7B are merely an exemplary approach to the release of the braid 10.
    [0085] Figures 8A to 8H represent examples of strand 10 being implanted and released to an exemplary aneurysm A. Specifically, in Figure 8A, strand 10 can be seen advanced forward into aneurysm A. The end 24 of microcatheter 20 was selectively positioned on the neck of aneurysm A, while end 14 of strand 10 is being advanced distally towards aneurysm A and away from end 24 of microcatheter 20. In Figures 8B and 8C, end 14 of strand 10 continues to move distally towards the dome D of aneurysm A, while a microcatheter 20 remains generally stationary until, as seen in Figures 8D to 8E, end 14 of braid 10 contacts the dome D and segment 12 begins to expand radially to form the external occlusive bag of the braid 10. In Figure 8C, in particular, the external occlusive bag of segment 12 is almost entirely formed according to the strand 10 continued its distal translation into aneurysm A. In Figure 8D, strand 10 continues to be translated distally until its
    Petition 870190016273, of 02/18/2019, p. 29/56
    27/31 external occlusive bag of segment 12 is completely formed. In Figure 8D, specifically, it can be seen that the external occlusive bag of segment 12 is now adjacent and supports the dome D. Meanwhile, the braid 10 can continue to be translated to form the internal occlusive bag of segment 13. The bag internal occlusive of segment 13, as shown, can overlap bag 12 to provide greater stability. In addition, the contact of the segment 12 with the dome causes the segment 12 to begin to form as the strand 10 expands.
    [0086] In Figure 8F, strand 10 continues to be pushed into the aneurysm wall, causing the internal occlusive bag of segment 13 to continue to expand, while the external occlusive bag of segment 12 continues to expand along aneurysm wall. In Figure 8G, the braid 10 continues its distal translation, whereby the internal occlusive bag of segment 13 was formed inside the external occlusive bag and its base end was pushed further into segment 12, similarly to the compression of the spiral. It is understood that any number of internal occlusive bags can be positioned internally to segment 12 (for example, by providing one or more additional segments capable of forming internal occlusive bags) and the one or more additional internal occlusive bags can be formed as per braid 10 is distally transferred into aneurysm A. A packing density of braid 10 can also be adapted or adjusted as braid 10 is distally translated to form the internal occlusive bag of segment 13 disposed internally in bag 12. For example, when comparing the arrangement of Figure 8F versus 8G, the stem portion behind the segment 13 internal occlusive bag can act to package the segment 12 external occlusive bag as it is distally translated. In Figure 8H, braid 10 was distally
    Petition 870190016273, of 02/18/2019, p. 30/56
    28/31 translated to the desired depth in aneurysm A and then the locking portion 54 is visible as being external to microcatheter 20 and in or adjacent to the neck of aneurysm A. Once the braid 10 and the corresponding segments 12 and 13 are now selectively positioned, expanded and disposed within aneurysm A, the release tube 30 and microcatheter 20 can be released from strand 10 and moved proximally away from aneurysm A. By the arrangement of segments 12 and 13, as shown in Figures 8A to 8H, and forming the external occlusive bag of segment 12 with a lower porosity than the internal occlusive bag of segment 13, the braid 10 can induce a flow deviation effect through the neck of the aneurysm. [0087] Figures 10A to 10D represent braided exemplary prototypes with various braiding properties. These prototypes are strictly for illustrative purposes.
    [0088] Figure 11 is a flow chart for an 1100 method of releasing an occlusive device to the aneurysm. Step 1105 includes sliding a release tube into a microcatheter. Step 1110 includes sliding an invertible and expandable strand into the microcatheter, the strand being in a retracted state within the microcatheter and comprising a distal end and a proximal end. Step 1115 includes securely attaching the proximal end of the braid to the distal end of the release tube. Step 1120 includes selectively positioning the microcatheter, the release tube and the braid within the aneurysm vasculature. For example, the microcatheter can position the braid and the release tube on the neck of the aneurysm. Step 1125 includes sliding the braid distally through the application tube towards the aneurysm. Before step 1125, the distal end of the braid can be inserted through a marker strip until a proximal end of the braid is over
    Petition 870190016273, of 02/18/2019, p. 31/56
    29/31 or adjacent to the marker strip. Step 1130 includes pushing the strand distally through the release tube into the aneurysm bag, whereby the strand expands radially to form an external occlusive bag with a lower operable porosity to extend through the aneurysm neck. 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 cup.
    [0089] Step 1135 includes expanding an inner layer of the braid inside the external occlusive sac, while pushing the occlusive sac against the aneurysm wall and the aneurysm neck. The inner layer that expands within the outer occlusive sac can form an inner occlusive sac and be formed by folding the proximal end over the marker strip and then pushing the strand distally into the aneurysm, as described. The porosity of the internal occlusive bag may be greater than the porosity of the external occlusive bag. Step 1140 includes releasing the occlusive device, including the external and internal occlusive bags, and removing the delivery tube and microcatheter from the aneurysm. By varying the porosity of the portions of the braid, when installed in the aneurysm and separated from the release system, the braid can induce a flow deviation effect through the neck of the aneurysm.
    [0090] Figure 12 is a flow chart for a 1200 method of occlusion of an aneurysm. Step 1205 includes placing a radially expandable braid within the vasculature of the aneurysm. Step 1210 includes forming a first radially expandable segment of the strand with a porosity less than that of a second radially expandable segment. Step 1215 includes pushing the strand distally into the aneurysm, whereby the first radially expandable segment expands radially to form
    Petition 870190016273, of 02/18/2019, p. 32/56
    30/31 an external occlusive bag. Step 1220 includes pushing the braid further distally, thereby expanding the second radially expandable segment within the outer occlusive bag. Step 1225 includes positioning the first radially expandable segment adjacent or in communication with an aneurysm neck. Step 1230 includes deflecting, deflecting or slowing the flow to the aneurysm through the neck of the aneurysm when the external occlusive sac is formed through the neck and the internal occlusive section is formed therein.
    [0091] It is understood that variations of braid 10 can include various materials, such as stainless steel, bioabsorbable materials and polymers. The 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, with the purpose of modeling 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. Additionally, the interstices of the braid 10 that form 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.
    [0092] 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 revealed technology. Such modifications are intended to be included within the scope of the disclosed technology. Therefore, the modalities disclosed herein are considered in all respects to be illustrative and not restrictive. So it will be
    Petition 870190016273, of 02/18/2019, p. 33/56
    31/31 evident from the aforementioned that, although specific forms of the disclosure have been illustrated and described, various modifications can be made without deviating from the character and scope of the disclosure, and all changes understood in the meaning and scope of their equivalents are designed to be included in them.
    权利要求:
    Claims (17)
    [1]
    1. Occlusive device to treat an aneurysm, characterized by the fact that it comprises:
    a strand being translatably implanted into a microcatheter from a retracted to an implanted state, with the strand comprising a distal end and a proximal end;
    in which, in the implanted state, the braid comprises:
    an external occlusive bag capable of pressing against an aneurysm wall; and an internal occlusive bag disposed within the external occlusive bag.
    [2]
    2. Device according to claim 1, characterized by the fact that the porosity of the internal occlusive bag is greater than that of the external occlusive bag.
    [3]
    3. Device according to claim 2, characterized by the fact that, in the implanted state, the external occlusive bag is able to seal against the neck of the aneurysm.
    [4]
    4. Device according to claim 1, characterized by the fact that moving the strand distally after the external occlusive bag is formed causes an internal layer of the strand inside the external occlusive bag to expand radially inside the external occlusive bag and forms the internal occlusive bag.
    [5]
    5. Device according to claim 4, characterized by the fact that the inner layer of the braid is capable of expanding radially within the external occlusive sac, while the external occlusive sac is pushed against the aneurysm wall and the aneurysm neck.
    [6]
    6. Device, according to claim 4, characterized by the fact that it additionally comprises a range
    Petition 870190016273, of 02/18/2019, p. 35/56
    2/5 marker in communication with the proximal end of the braid, in which the inner layer that expands radially inside the external occlusive bag can be formed by folding the proximal end over the marker band.
    [7]
    7. Device, according to claim 1, characterized by the fact that, in the implanted state, the braid is removable from a release system in the aneurysm.
    [8]
    8. Device according to claim 7, characterized by the fact that the delivery system comprises:
    a microcatheter; and a release tube comprising a distal end and a proximal end, where the distal end of the release tube is removably connected to the proximal end of the strand, where the release tube is translatably implantable within the microcatheter;
    in which the release tube is capable of distally transferring the braid inside the microcatheter from the retracted state to the implanted state.
    [9]
    9. Device according to claim 1, characterized by the fact that the external occlusive bag comprises fewer segments of wire than the internal occlusive bag.
    [10]
    10. Stranded to treat an aneurysm, characterized by the fact that the strand 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 capable of expanding radially to form an external occlusive sac in the aneurysm in the implanted state that it can be sealed against an aneurysm neck;
    a second radially expandable and operable segment
    Petition 870190016273, of 02/18/2019, p. 36/56
    3/5 to move from the retracted state inside the microcatheter to the implanted distal state of the microcatheter, where the second radially expandable segment is capable of expanding radially within the external occlusive sac to form an internal occlusive sac in the external occlusive sac in the implanted state .
    [11]
    11. Braid, according to claim 10, characterized by the fact that the braid can be removably implanted by a release system in an aneurysm.
    [12]
    12. Braided according to claim 10, characterized by the fact that it also comprises a buckle portion disposed between the first and the second radially expandable segments, with the buckle portion allowing the inner occlusive bag to be formed inside, covered with and expand into the outer occlusive bag.
    [13]
    13. Braided according to claim 10, 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 when positioned through the neck of the aneurysm.
    [14]
    14. Method to close an aneurysm, characterized by the fact of understanding:
    positioning a radially expandable braid as defined in claim 10 in the aneurysm vasculature;
    forming the first radially expandable segment of the strand with less porosity than a porosity of the second radially expandable segment;
    push the braid distally into the aneurysm, whereby the first radially expandable segment expands radially to form an external occlusive sac;
    Petition 870190016273, of 02/18/2019, p. 37/56
    4/5 push the braid more distally, thus expanding the second radially expandable segment inside the external occlusive bag;
    positioning the first radially expandable segment adjacent or in communication with an aneurysm neck;
    deflect, deflect or slow the flow to the aneurysm through the neck of the aneurysm when the external occlusive sac is formed through the neck and the internal occlusive section is formed therein.
    [15]
    15. Method for releasing an occlusive device to an aneurysm, characterized by the fact that it comprises:
    slide a release tube into a microcatheter;
    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;
    fix the proximal end of the braid to the distal end of the release tube;
    selectively position the microcatheter, the release tube and the braid in the vasculature of the aneurysm;
    slide the microcatheter braid distally through the release tube towards the aneurysm;
    push the strand distally through the release tube into the aneurysm so that a first radially expandable segment of the strand expands radially to form an external occlusive bag, the external occlusive bag being operable to extend through an aneurysm neck ;
    advance the strand even further distally, thereby increasing a second radially expandable segment within the strand into the outer occlusive bag by pushing distally
    Petition 870190016273, of 02/18/2019, p. 38/56
    5/5 the external occlusive sac against the aneurysm wall and the aneurysm neck; and release the braid, including the external and internal occlusive bags, and remove the release tube and microcatheter from the aneurysm.
    [16]
    16. Method, according to claim 15, characterized by the fact that it additionally 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 deflect, deflect or slow the flow to the aneurysm through the neck of the aneurysm when the external occlusive sac is formed through the neck and the internal occlusive section is formed therein.
    [17]
    17. Method according to claim 15, characterized by the fact that the inner occlusive bag comprises an inner layer of the braid.
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    同族专利:
    公开号 | 公开日
    IL263833D0|2019-03-31|
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    US20190192167A1|2019-06-27|
    KR20190076917A|2019-07-02|
    TW201936124A|2019-09-16|
    JP2019111343A|2019-07-11|
    US10751065B2|2020-08-25|
    CN109984799A|2019-07-09|
    US20200375607A1|2020-12-03|
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    RU2018145502A|2020-06-22|
    MX2019000155A|2019-09-04|
    CA3028198A1|2019-06-22|
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    法律状态:
    2019-07-09| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US15/852,829|2017-12-22|
    US15/852,829|US10751065B2|2017-12-22|2017-12-22|Aneurysm device and delivery system|
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