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    • 专利摘要:
    aneurysm release device and system. The present invention relates to a braid for treating an aneurysm. The braid may include a distal end and a proximal end. translation of the braid may cause the release portion to expand and form a distal sac as well as to reverse itself.
    公开号:BR102019011023A2
    申请号:R102019011023
    申请日:2019-05-29
    公开日:2019-12-03
    发明作者:Sotodelvalle Ariel；Lorenzo Juan；Gorochow Lacey
    申请人:Depuy Synthes Products Inc；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for "DEVICE AND RELEASE SYSTEM FOR ANEURISM".
    FIELD OF THE INVENTION
    [001] The present invention relates to medical instruments, and more particularly, to delivery systems for aneurysm treatment. 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 arterial blood flow and 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, such occlusive devices have certain disadvantages, including a mass effect, which can cause compression in the brain and its nerves. In addition, embolization springs do not always effectively treat aneurysms, as aneurysm recanalization and / or spring compression can occur over time.
    [005] A specific type of occlusive approach strives to release and treat the entrance or "neck" of the aneurysm as opposed to the volume of the aneurysm by implanting a device in the main vessel of the aneurysm. In such "neck" approaches, by minimizing blood flow through the neck, a cessation of flow into the aneurysm can be achieved. In turn, a thrombotic mass can form naturally without having to supply embolic materials to the aneurysmal sac, as previously described. This approach 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 shape of the original main 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 main wall would be if the aneurysm did not exist. However, occlusive approaches to the neck, such as the implantation of a flow-preventing device in the main vessel, have disadvantages. This type of approach can impede blood flow to the peripheral blood vessels while blocking the neck of the aneurysm in the main vessel. Blocking the flow to the peripheral blood vessel can unintentionally cause serious damage if the vessel openings are blocked.
    [006] The solution of this description solves these and other problems of the technique.
    SUMMARY OF THE INVENTION
    [007] In some embodiments, the present description refers to a braid to treat an aneurysm. The braid can include a proximal end and a distal end. The braid may also include a distal segment arranged around the distal end. The distal segment can be configured to transition from a retracted state within a microcatheter to a distal positioned state of the microcatheter, so that the distal segment has expanded radially to form a distal sac. A central segment can be arranged in communication with the distal segment. The central segment may be able to invert the distal sac. A distal proximal segment can be arranged in communication with the central segment and arranged around the proximal end. The proximal segment may be able to be inserted into the central segment in the positioned state. Each of the proximal, distal and central segments may have different porosity and / or different flexibility.
    [008] In some modalities, the distal, central and proximal segments are formed from a single monolithic structure.
    [009] In some modalities, the distal, central and proximal segments are connected components distinct from a single mesh. [0010] In some modalities, an inflection point is arranged between the central segment and the distal segment. The proximal end of the braid can be configured to be inserted into the distal sac in the positioned state until the central segment is inverted so that the point of inflection is arranged adjacent to the neck of the aneurysm to induce a flow deviation effect.
    [0011] In some modalities, a braid is described to treat an aneurysm. The braid can include a proximal end and a distal end. The braid may also include a distal segment disposed around the distal end, the distal segment being operable to transition from a retracted state within a microcatheter to a distal positioned state of the microcatheter, so that the distal segment expands radially to form a distal sac. A proximal segment can be arranged around the proximal end, where the proximal segment is able to invert and be placed in the distal sac.
    [0012] In some embodiments, the proximal segment includes greater porosity than distal segment porosity, or vice versa. The proximal end can be configured to be inserted into the distal sac in the positioned state until a proximal end of the distal segment is disposed adjacent to the neck of the aneurysm to induce a flow deviation effect. The distal bag can also be spherical, although the braid is not so limited and its distal bag can take any shape as needed or required. The distal segment may include greater flexibility than flexibility of the proximal segment, or vice versa.
    [0013] In some modalities, the braid may also include an inflection point arranged between the proximal and distal segments. The proximal segment can also be configured to be inverted when the inflection point is distal from the microcatheter. The proximal segment can be configured to be inverted by the inflection point when the strand has been moved distally at a predetermined distance from the microcatheter and / or the aneurysm.
    [0014] In some modalities, the proximal segment is configured to be inverted in the distal segment as the strand is distally pushed deeper into the aneurysm. The proximal segment can be configured to be inverted in the distal segment into a plug-in tube shape.
    [0015] In some embodiments, the distal sac has a diameter at least twice as large as the microcatheter. However, the diameter of the distal sac in the positioned state may be larger or smaller, as required or necessary according to the specific aneurysm being occluded.
    [0016] In some modalities, the braid can also include a central segment disposed between the proximal and distal segments. Each of the proximal, distal and central segments can include different flexibility. The central segment may include greater flexibility than flexibility of the proximal and distal segments. The flexibility of the distal segment may be greater than the flexibility of the proximal segment. In some modalities, in the positioned state, at least some of the central segments can be tapered where the central segment communicates with the distal segment.
    [0017] In some modalities, each of the proximal, distal and central segments comprises a different porosity. The central segment may include a porosity greater than a porosity of the proximal and distal segments. The porosity of the distal segment may be greater than the porosity of the proximal segment. The central segment can be configured for positioning on or adjacent to the neck of the aneurysm in the position positioned to induce a flow deviation effect.
    [0018] In some embodiments, a first inflection point can be disposed between the distal segment and the central segment and a second inflection point can be disposed between the central segment and the proximal segment. In the positioned state, the first inflection point is configured to cause the proximal end of the distal segment to buckle when the braid is moved distally at a first distance. In the positioned state, the second inflection point is configured to cause the central segment to reverse to the distal segment when the strand is moved distally a second distance. In other embodiments, in the positioned state, the first inflection point is configured to cause the proximal end of the distal segment to buckle around the neck of the aneurysm and the second inflection point is configured to cause the central segment to reverse to within the distal segment. In other embodiments, when the first inflection point is distal from the microcatheter (for example, inside the aneurysm), the first inflection point is configured to cause the proximal end of the central segment to buckle around the neck of the aneurysm and when the second inflection point is distal from the microcatheter, the second inflection point is configured to cause the central segment to buckle around the distal segment and the proximal segment to insert itself into the central segment. [0019] In some modalities, the proximal and / or central segment are / are configured to be inserted into the distal sac in the positioned state until the first inflection point is placed adjacent to the neck of the aneurysm to induce a flow deviation effect. The proximal segment and the central segment can also be configured to be inverted in the distal segment in a plug-in tube shape.
    [0020] In certain embodiments, an occlusive system for treating an aneurysm is described. The system can include a microcatheter and a delivery tube that are translatable in the microcatheter. A strand can also be included and connected with the strand being removably connected to the release tube (for example, a latch portion disposed at the proximal end of the strand connected removably to the distal end of the release tube) and disposed of. sliding way inside the microcatheter in a retracted and distally translatable state from inside the microcatheter to a state positioned distal from the microcatheter in the aneurysm. The strand can expand, including the distal, central and / or proximal expandable segments, to the state positioned as the distal end of the strand exits distally from the microcatheter, comes into contact with the aneurysm wall and / or is otherwise disposed within the aneurysm, distal from the microcatheter.
    [0021] In some modalities, the translation of the braid distally in the opposite direction to the microcatheter causes the central segment to invert to the distal sac and the proximal segment to insert into the central segment. In some embodiments, the central segment may include porosity greater than that of the proximal and distal segments. The porosity of the distal segment may be greater than the porosity of the proximal segment. The central segment can be configured for positioning on or adjacent to the neck of the aneurysm in the position positioned to induce a flow deviation effect.
    [0022] In some modalities, in the positioned state, the braid is removable from the microcatheter and / or the release tube in the aneurysm. [0023] In some embodiments, the system may also include radiopaque entities such as platinum wires woven into the braid, or wires from filled tubes pulled with platinum so that the device can be viewed under fluoroscopy. Including these entities will allow the user to understand and visualize the location of the distal sac in relation to the aneurysm. The orientation and / or position of the distal bag or any other feature of the braid is adjustable by the braid being moved distally or proximally by the release tube.
    [0024] In some modalities, the system may also include an imaging device operatively connected to the occlusive device. The imaging device is capable of imaging the distal sac in relation to the aneurysm so that a distal orientation and / or position of the sac or any other feature of the braid is adjustable by the braid being moved distally or proximally by the release tube.
    [0025] In some modalities, a method of occluding an aneurysm is described. The method may include selectively placing a braid on or adjacent to an aneurysm neck; slide the braid distally into the aneurysm; radially expand a distal segment of the braid to form a distal sac within the aneurysm, the distal sac configured to occlude the aneurysm; slide the braid more distally into the aneurysm, thus buckling the distal segment buckle around the neck of the aneurysm; sliding the braid more distally into the aneurysm thus inverting a central segment of the braid in the distal segment; insert a proximal segment of the strand in the central segment; and release the braid inside the aneurysm.
    [0026] In some modalities, the method may include inserting the proximal segment in the central segment until an inflection point between the distal segment and the central segment is adjacent or in communication with the neck of the aneurysm; and induce a flow-diverting effect through the neck of the aneurysm. In some embodiments, during said insertion, the distal segment does not move in relation to the distal segment.
    [0027] In some modalities, the method may include the positioning of a first inflection point between the distal segment and the central segment; positioning a second inflection point between the central segment and the proximal segment; buckle the distal segment around the neck of the aneurysm, by the first point of inflection, when moving a proximal end of the braid distally at a first distance from the neck of the aneurysm; and inverting the central segment in the distal segment, by the second point of inflection, with the proximal end of the braid distally moving a second distance in relation to the neck of the aneurysm. In some modalities, the inversion of the central segment in the distal segment, by the second point of inflection, causes the central segment to taper into the distal segment. The tapered portion between the central and distal segments can also be arranged over or adjacent to the neck of the aneurysm in the positioned state.
    [0028] In some modalities, the method may include forming the central segment with a porosity greater than that of the proximal and distal segments; and forming the porosity of the distal segment greater than the porosity of the proximal segment.
    [0029] In some modalities, a method of occluding an aneurysm is described. The method may include placing a strand with the release tube, the strand being in a retracted state with the microcatheter; selectively position the microcatheter, the release tube and the braid over or adjacent to the neck of the aneurysm; slide the braid distally, through the release tube, from the microcatheter into the aneurysm; radially expand a distal segment of the braid to form a distal sac within the aneurysm, the distal sac configured to occlude the aneurysm; slide the braid more distally through the release tube, thus buckling the distal segment over the neck of the aneurysm; slide the braid more distally, through the release tube, thus inverting a central segment of the braid proximal to the distal segment into the distal sac; insert a proximal segment close to the distal segment into the central segment; and release the braid into the aneurysm and remove the release tube and microcatheter from the aneurysm.
    [0030] In some modalities, the method may include the positioning of a first inflection point between the distal segment and the central segment; positioning a second inflection point between the central segment and the proximal segment; buckle the distal segment around the neck of the aneurysm, by the first point of inflection, when moving a proximal end of the braid distally at a first distance from the neck of the aneurysm; and inverting the central segment in the distal segment, by the second point of inflection, with the proximal end of the braid distally moving a second distance in relation to the neck of the aneurysm.
    [0031] In some embodiments, the inversion of the central segment in the distal sac creates a flow deviation effect through the neck of the aneurysm.
    [0032] In some modalities, the method may include the formation of each of the proximal, distal and central segments with a different porosity.
    [0033] In some embodiments, the method may include forming the central segment with a porosity greater than that of the proximal and distal segments; and forming the porosity of the distal segment greater than the porosity of the proximal segment.
    [0034] In some modalities, the method may include inserting the proximal segment in the central segment until the central segment is adjacent or in communication with the neck of the aneurysm; and induce a flow-diverting effect through the neck of the aneurysm. [0035] Other aspects and characteristics of the present 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
    [0036] Reference will now be made to the attached drawings, which are not necessarily drawn to scale.
    [0037] Figure 1 shows an occlusive device exemplifying this description partially positioned in an aneurysm;
    [0038] Figure 2 is a schematic side view of an exemplary delivery system with an occlusive device in communication with, and positioned from, a microcatheter;
    [0039] Figure 3 is an enlarged schematic side view of the braid of Figures 1 to 2 in an expanded state;
    [0040] Figure 4A is an enlarged schematic side view of the release system and strand of Figures 1 to 3 as the strand is being continuously pushed into an exemplary aneurysm;
    [0041] Figure 4B is an enlarged schematic side view of the release system and strand of Figures 1 to 3 as the strand is being pushed into an exemplary aneurysm; [0042] Figure 5A is an enlarged schematic side view of the release system and strand of Figures 1 to 3 as the strand is being pushed into an exemplary aneurysm; [0043] Figure 5B is an enlarged schematic side view of the release system and strand of Figures 1 to 3 after the strand has been positioned in an exemplary aneurysm;
    [0044] Figure 6A is a schematic perspective view showing an exemplary delivery system for use with an exemplary occlusive device;
    [0045] Figure 6B is a schematic perspective view of Figure 6A, but with the partial cross section of the delivery system and the occlusive device;
    [0046] 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;
    [0047] Figure 7B is a schematic perspective view of Figures 6A - 6B positioned with the exemplary release system separate from the occlusive device;
    [0048] Figure 8 is a flow chart for a method of releasing an occlusive device.
    [0049] Figure 9 is a flow diagram for a method of releasing an occlusive device.
    DETAILED DESCRIPTION
    [0050] 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.
    [0051] It should also be noted that, as used here and in the appended claims, the singular forms "um", "uma", "o" and "a" include the respective plural forms, unless the context clearly determine otherwise. By "comprising" or "containing" or "including" is meant 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 method steps, even if the other such compounds, materials, particles or method steps have the same function as the one named.
    [0052] 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 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.
    [0053] As discussed in this document, the vasculature of an "individual" or "patient" can be the vasculature of a human or an 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. [0054] As discussed in this document, "operator" may include a doctor, surgeon or any other individual or release instrument associated with the release of a body braided to an individual's vasculature.
    [0055] Returning to Figure 1, an exemplary strand 10 of the present description is shown positioned in an aneurysm A of a BV blood vessel but not yet released from microcatheter 20, including the release tube 30 which is disposed in it, which is shown more clearly in Figure 2. Braid 10 addresses the disadvantages of coils as it is a single device configured to treat aneurysm A and improves the sealing of the aneurysm neck. In Figure 1, microcatheter 20 was released to the neck of aneurysm A and a distal sac formed by a distal segment 12 of the braid 10. Braid 10 is shown forming a predetermined shape and structure configured to contour and support the walls of aneurysm A .
    [0056] The size of microcatheter 20 shown in Figure 1 is selected taking into account the size, shape and directionality of the aneurysm or body lumens that the catheter needs to 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 internal diameter D1 anywhere between 0.038 and 0.081 centimeters (0.015 and 0.032 inches). 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 operated manually by the end user, and at its distal end 24 it can be operated, as illustrated, to be positioned on the neck of aneurysm A. While the distal end 24 of microcatheter 20 can contain the braided 10, the end 24 can vary in shape and can bend at an angle.
    [0057] Returning to Figure 2, a schematic side view of the braid 10 is shown when connected to the release tube 30 and being positioned from the microcatheter 20 in a positioned configuration, but before being positioned in aneurysm A. The release tube 30 may be able to be pushed distally through the microcatheter 20. The release tube 30 may be substantially elongated and may extend from the proximal end 26 to the distal end 24 of the microcatheter 20. The tube 30 may, 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 delivery tube 30 and the microcatheter 20 can be axially aligned. The release tube 30 and the microcatheter 20 together can release the braid 10 to a location of interest (for example, an injury site). In certain modalities, the microcatheter 20 can be pre-placed at a level in the neck of the aneurysm and used to trace the braid 10 to the injury. The release tube 30 can be in mechanical connection with the braid 10 in the lock portion 54. The braid 10 can be fixed to the lock portion 54 by sliding fixation, permanent fixation (for example, crimped, laser, ultrasonic welding or other sources heat, adhesive, or the like) or other removable 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 braid 10 to begin to move from a retracted state inside the microcatheter 20 to a state positioned externally to the microcatheter 20 with the distal braid bag 10, to obstruct aneurysm A, as discussed more particularly below.
    [0058] Braid 10 can include an open distal end 14 and a proximal end 16. Braid 10 can be formed from a self-expanding and invertible multi-filament structure that includes a tubular or braided mesh. The distal strand bag 10 can be formed during positioning as the distal end 14 of strand 10 slides out of microcatheter 20 and enters aneurysm A. The mesh of strand 10 can be defined by one or more mesh patterns with openings of mesh defined by twisted filaments. The braid mesh 10 can be produced from various materials, such as deposited thin films. The mesh of braid 10 can include multiple threads, for example, from 4 to 96 threads. The number of threads, thread angle and thread diameter can all be factors in controlling the material properties of the braid 10, including porosity and flexibility.
    [0059] The positioned state of strand 10, including the distal segment 12 bag, can be formed by strand 10 being moved distally from a retracted state inside the microcatheter 20 and fixed to the release tube 30 and then being positioned in an aneurysm A , distal from microcatheter 20. The mesh of strand 10 is configured so that as strand 10 is distally translated and its end 14 comes out of microcatheter 20, portions of strand 10, including distal segment 12, can begin to expand radially. As strand 10 is still translated, segments from strand 10 proximal to segment 12, including central segment 11 and / or proximal segment 13, may also begin to expand, buckle and / or cause it to reverse to strand 10, when inside aneurysm A. The wires can be produced from multiple alloys such as a nickel and titanium alloy, cobalt and chromium alloys, platinum, nitinol, stainless steel, tantalum or other alloys, or any other suitable biocompatible materials, or combination of these materials. In addition, these materials may be absorbable or non-absorbable by the patient over time. In some embodiments, some or all of the braid 10 can be a cylindrical mesh of multifilaments produced preferably from nitinol with interwoven platinum filaments for radiopacity, or nitinol from filled drawn tube (DFT) with 10 to 40% platinum. 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.
    [0060] Returning to Figure 3, an enlarged schematic side view of the braid 10 of Figures 1 to 2 is shown in an expanded, approximate state. Other portions of the mesh of braid 10 may have different porosities and / or other material properties, including segments 11 and 13 of braid 10. Braid 10 may include several segments, including a distal bag in a generally spherical shape associated with segment 12 in the positioned state. The central segment 11 can be in communication with the segment 12 and be tapered as it communicates from a relatively elongated portion adjacent to segment 13 to the distal sac of segment 12. In other words, segment 11 can include a tapered portion and an elongated tubular portion where segment 11 communicates with segment 13. Segment 13 in turn can be substantially elongated and extend proximally from segment 11 to the locking portion 54 and / or the release tube 30, when mounted with microcatheter 20. Segment 13 may have the same diameter as that of the proximal end of segment 11 or segment 13 may also have a smaller diameter than segment 11. In this respect, braid 10 may include three porous segments, including those segments 11, 12 and 13, and each of segments 11,12 and 13 can have variable flexibility and / or porosity. For example, segment 11, including its tapered portion, may be relatively soft and flexible while segment 11 in which it communicates with segment 13 may be less flexible with a lower porosity. Variable flexibility and / or porosity in this way can induce segment 12 to buckle and / or cause segment 11 to flip over itself like a sock as its proximal, more rigid end is pushed distally further into the distal sac of segment 12.
    [0061] Segment 11 of strand 10 may have a lower porosity than the porosity of segment 13 and / or the bag segment 12. The porosities associated with segments 11, 12, 13 and / or any other region or segment of the strand 10 may include filaments that have a different shape than the filaments in the other porosity regions. Segment 13 of strand 10 similarly may have a porosity or flexibility that differs from that of segments 11 and 13. For example, the porosity of segment 13 may be less than the porosities of segment 11 and / or 12. Segment 13 they can also be less flexible than segment 11 and / or segment 12 in order to induce inversion of strand 10 during release and inversion as strand 10 and expand in aneurysm A. Strand 10 can also be produced from nitinol with interwoven platinum filaments for radiopacity. The varied properties of segments 11, 12 and 13 can allow braid 10 to reverse over itself (like a sock) as braid 10 is positioned on aneurysm A.
    [0062] To facilitate the inversion of braid 10, including the inversion of segment 11 into segment 12, braid 10 can be modified to weaken segment 12 (for example, facilitating buckling of segment 12 after the formation of the distal sac within aneurysm A) or otherwise make segment 11 more likely to reverse. For example, braid 10 can include an inflection point 9 arranged between segments 11 and 12 and / or between segments 11 and 13 communicating with each other. The inflection point 9 can be a localized region or it can act as a boundary or separation between each contiguous segment. The inflection point 9 can be a pre-weakened area that induces buckling 10 or buckling 10, as required or necessary. Braid 10 is not so limited, however, and other properties can be modified to induce inversion, including a change in localized braid angle, removal of wire segments over the tapered area of segment 11, and / or a heat treatment located to change the properties of the strand. As illustrated, segments 11, 12 and 13 can be configured so that segment 12 can be buckled around the neck of the aneurysm during positioning so that segment 11 can be inverted into segment 12. This innovative braid 10 it is particularly advantageous in that the buckling of segment 12 serves as a safety mechanism that prevents segment 12 from expanding too much and risking aneurysm rupture A. The inversion of segment 11 on or adjacent to the neck of aneurysm by can in turn induce a flow deviation effect through the aneurysm neck A. This is due to the fact that segment 13 may be in communication with the aneurysm neck when braid 10 is inverted and positioned on the aneurysm, since the end 16 can be inserted into the segment 12 (for example, see Figure 5B).
    [0063] In certain embodiments, a braid angle of one or some of the segments 11,12,13 of braid 10 can vary in relation to a longitudinal axis of braid 10. The diameter of the wire, number of passes (that is, the number of wire intersections per linear measurement) of the strand 10 can also vary or otherwise be modified between strand 10 segments to change the characteristics of the device as well as the heat-treated shape. The diameter of braid 10 in the positioned state, including the expanded diameter of the distal bag of segment 12, and the count of braided threads may vary depending on the diameter of the distal bag necessary to treat aneurysm A. However, braid 10 is not as limited and may have a braided angle, step count, wire diameter, porosity or any other property of braid 10 that is substantially similar. The fibers of the braid 10 can be formed by being fixed at their free ends at the end 16 by hot bonding by laser or ultrasonic welding, bonding by solvent or adhesive, crimping or any other means of fixation. The fibers of each strand 10 segment can be linked at their internal intersection points by solvent, adhesive, or hot bonding, such as laser, ultrasonic solder or any other heat source to decrease flexibility in certain strands 10.
    [0064] Figures 4A to 5B show an enlarged schematic side view of the braid 10 attached to the release tube 30 and partially arranged in the microcatheter 20 as the braid 10 is pushed out of the microcatheter 20 into an exemplary aneurysm A. The diameter outer segment 12 is illustrated in Figures 4A to 5B expand radially to a diameter larger than microcatheter 20 when the distal sac is formed (for example, greater than twice the diameter of microcatheter 20). As shown in Figure 4A, segment 12 of strand 10 has expanded from a retracted state disposed within microcatheter 20 to a positioned state, distal from microcatheter 20 and beginning to form the distal sac of segment 12 within aneurysm A. The joint between the microcatheter 20, release tube 30 and / or braided 10 can occur before being introduced into the vasculature. The distal sac of segment 12 is illustrated radially, expanding towards the external walls of aneurysm A, while the proximal segments of it (for example, segments 11, 13) continue to be distally translated by the release tube 30 deeper into of aneurysm A. Segment 12 in Figure 4A is beginning to assume a generally spherical shape internal to aneurysm A when strand 10 is transferred distally to aneurysm A, furthest from catheter 20.
    [0065] In Figure 4B, the release tube 30 moves distally deeper into aneurysm A. In turn, the inflection point 9 arranged between segments 11 and 12 causes the segment 12 to buckle. With buckling, the portions of segment 12 adjacent to the neck of aneurysm A flex or otherwise contour distally from the inflection point 9. As shown, the portions of segment 12 curve around segment 11 for the expanded occlusion configuration desired after segment 12 is buckled.
    [0066] In Figure 5A, the release tube 30 is further pushed distally into aneurysm A until segment 11 is fully within the distal sac of segment 12 and end 16, including lock portion 54, is at or adjacent to the neck level of aneurysm A. In Figure 5A, segment 11 has reversed as a result of being moved distally deeper into aneurysm A after segment 12 buckled in Figure 4B. In one example, the inversion of segment 11 into segment 12 can occur when the end 14 or extensions of segment 12 of strand 10 are relatively fixed against the wall of aneurysm A while the release tube 30 pushes distally in the opposite direction to microcatheter 20. Segment 12 is also illustrated having expanded from an unexpanded pre-positioning state to the bag shown in Figure 4B and this expansion is caused by the release tube 30 being driven distally. The release tube 30 can be driven by a hypotube from its proximal end 36 by an operator or the like. The inversion of strand 10 in segments 11 and 13 can be similar to how a pipe socket is configured to invert itself. By reversing segment 11 into segment 12, the release tube 30 can continue to push segment 13 distally into segment 11 as shown. In particular, segment 13 can be inserted into segment 11 in the positioned state. In certain modalities, as segment 13 is pushed distally deeper into segment 11, segment 11 is caused to taper at the junction between segment 11 and segment 12. In certain modalities, as this tapering occurs, the proximal portions of the segment 12 on or adjacent to the neck are caused to mix and / or contour the neck of the aneurysm, thus inducing a flow deviation effect in the vasculature.
    [0067] In certain embodiments, segment 13 may only be structurally capable of being inserted into segment 11 a predetermined distance and, thus, prevented from being inserted more deeply into aneurysm A. For example, segment 13 may be able to be inserted until the inflection point 9 of segments 11 and 12 is placed on or adjacent to the neck of the aneurysm. This serves as an additional safety feature of the braid 10, since the segment 12 distal bag could be prevented from expanding beyond a predetermined diameter. As shown in Figure 5A, the inflection point 9 between segments 11 and 12 is illustrated on or adjacent to the neck of aneurysm A, while the second inflection point 9 between segments 11 and 13 is more deeply disposed on aneurysm A ( for example, centrally located in it). In that regard, segment 11 is now fully inverted into the distal bag 12 while segment 13 is completely inverted into segment 12. The lock portion 54 and / or portions of the release tube 30 may be at the neck level of the aneurysm A as seen under fluoroscopy. A release tube 30 can slide the strand 10 distally to the end 16 and / or locking portion 54 is inserted into aneurysm A.
    [0068] Microcatheter 20 may remain relatively stationary or fixed during the exemplary release shown in Figures 4A to 5B. As segments 11, 12 and 13 can include different braiding properties, including flexibility and / or porosity, inversion of segment 11 into segment 12 and / or inserting segment 13 into the inverted segment 11 is particularly advantageous. For example, the inversion of segment 11 and / or the insertion of segment 13 prevents the braid 10 from creating a protuberance that would otherwise extend into the main vessel. Instead, this protuberance is now inverted and inserted into the distal sac of braid 10 in aneurysm A. The inversion of segment 11 and / or insertion of segment 13 may also prevent braid 10 from otherwise disrupting aneurysm A by moving to the positioned state.
    [0069] It is understood that the inflection points 9 can be formed in the interstices of the strand 10 between segments 11, 12, 13 so that the buckling of segment 12 and / or inversion of segment 11 occurs after the strand 10 has moved distally at a predetermined distance outside the microcatheter 20. For example, the distal translation of the strand 10a a first distance, in relation to aneurysm A, can cause segment 12 to buckle around the neck of the aneurysm. The distal translation of the braid at a second distance, in relation to aneurysm A, can cause segment 11 to reverse to segment 12. Points 9 can be one or more weakened regions, areas or pre-established buckling points for a bag distal of specific size. Alternatively, no inflection point can be included and instead braid 10 can buckle, flip and bend itself after end 14 of the braid comes into contact with the dome of aneurysm A (for example, based on pre flexibility -selected from strand 10 and / or heat setting from strand in a specific way).
    [0070] When segments 11, 12 and 13 are selectively positioned and arranged for the desired condition (for example, braid 10 has been moved distally to aneurysm A to expand segment 12 to form its bag, buckle, segment 11 has been inverted and the segment 13 inserted in it), the braid 10 can be separated from the release tube 30, as shown in Figure 5B. In particular, Figure 5B illustrates the segment 12 distal sac completely formed in a manner sufficient to occlude aneurysm A. However, if the segment 12 sac is not precisely positioned or if the segment 12 and / or any internally disposed segment proximal while it needs to be reset or adjusted into aneurysm A, the braid 10, including segments 11, 12 and 13, can be retracted back into microcatheter 20 by proximally removing the release tube 30 back into microcatheter 20 while still attached to the braid 10. In Figure 5A, as the segment 12 bag was selectively positioned and formed inside aneurysm A, the release tube 30 can be moved proximally into the microcatheter 20 and both can be retracted from of strand 10 and aneurysm A.
    [0071] Figures 6A to 7B generically illustrate an example of fixation and release between release tube 30 and strand 10 to position and release strand 10 in aneurysm A. The modalities of Figures 6A to 7B are merely a way in which the release tube 30 and the strand 10 can be attached at the end 34, and any number of securing means is contemplated as needed or required. The release tube 30, as shown, may have a lumen extending from a proximal end 36 to a distal release end 34. Figure 6A illustrates braid 10 engaged with locking member 52 and loop wire 58 locked in the locking portion 54. The opening 59 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 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 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 59, 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.
    [0072] The compressible portion 38 may allow the release tube 30 to flex and / or bend. Such flexibility can help to monitor the braid 10 through the microcatheter 20 and in the tortuous trajectory 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.
    [0073] A force F was previously applied to place the release tube 30 in a compressed state. Figure 6B illustrates the locking member 52 pulled proximally to initiate the release sequence for the braid 10. Figure 7A illustrates the instant when the locking member 52 leaves the opening 59 and is released from the loop wire 58. The end distal 62 from the loop wire 58 vanishes / returns to its preformed shape and exits the lock portion 54. As can be seen, there is now nothing to attach the braid 10 to the release tube 30. Figure 7B 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 provided by the distal end 34 of the release tube 30 so that the braid 10 "pushes" it into shape to ensure a clean separation and the release of braid 10 into aneurysm A. It must be understood that the release scheme described in Figures 6A and 7B is merely an exemplary approach to the release of the braid 10.
    [0074] Figure 8 is a flow chart for an 800 method of occlusion of an aneurysm. Step 805 includes selectively placing a braid over or adjacent to an aneurysm neck. Step 810 includes sliding the braid distally into the aneurysm. Step 815 includes expanding a distal segment of the braid radially to form a distal sac within the aneurysm, the distal sac being configured to occlude the aneurysm. Step 820 also includes sliding the braid distally into the aneurysm, thus buckling the distal segment buckle around the aneurysm neck. Step 825 also includes sliding the braid distally into the aneurysm, thereby inverting a central segment of the braid in the distal segment. Step 830 includes inserting a proximal end of the strand into the central segment. Step 835 includes releasing the strand within the aneurysm.
    [0075] Method 800 may also include inserting the proximal segment into the central segment until the proximal segment is adjacent to or communicating with the neck of the aneurysm; and induce a flow deviation effect through the aneurysm neck. Method 800 may also include positioning a first inflection point between the distal segment and the central segment; positioning a second inflection point between the central segment and the proximal segment; buckle the distal segment around the neck of the aneurysm, by the first point of inflection, when moving a proximal end of the braid distally at a first distance from the neck of the aneurysm; and inverting the central segment in the distal segment, by the second point of inflection, with the proximal end of the braid distally moving a second distance in relation to the neck of the aneurysm.
    [0076] Method 800 may also include forming the central segment with a porosity greater than that of the proximal and distal segments; and forming the porosity of the distal segment greater than the porosity of the proximal segment, or vice versa. Method 800 may also include reversing the central segment in the distal segment, by the second inflection point, which causes the central segment to be inserted into the distal segment.
    [0077] Figure 9 is a flow chart of a 900 method of occlusion of an aneurysm. Step 905 may include placing a strand with the release tube, the strand being in a retracted state with the microcatheter. Step 910 may include selectively positioning the microcatheter, the release tube and the braid over or adjacent to the neck of the aneurysm. Step 915 may include sliding the braid distally through the release tube of the microcatheter towards the aneurysm. Step 915 may include radially expanding a distal segment of the braid to form a distal sac within the aneurysm, the distal sac configured to occlude the aneurysm. Step 920 may also include sliding the braid distally through the release tube, thereby buckling the distal segment around the neck of the aneurysm. The step 930 may also include the distal sliding of the braid through the release tube, thus inverting a central segment of the braid proximal to the distal segment in the distal sac. Step 935 may include inserting a proximal segment, proximal to the central segment into the central segment. Step 940 may include releasing the strand within the aneurysm and removing the release tube and microcatheter from the aneurysm.
    [0078] Method 900 may also include the positioning of a first inflection point between the distal segment and the central segment; positioning a second inflection point between the central segment and the proximal segment; buckle the distal segment around the neck of the aneurysm, by the first point of inflection, distally moving a proximal end of the braid at a first distance from the microcatheter; and inverting the central segment in the distal segment, by the second point of inflection, translating the proximal end of the braid distally to a second distance in relation to the microcatheter.
    [0079] Method 900 may also include inverting the central segment into the distal sac which creates a flow deviation effect through the neck of the aneurysm. Method 900 may also include the formation of each of the proximal, distal and central segments with a different porosity. Method 900 may also include forming the central segment with a porosity greater than that of the proximal and distal segments; and forming the porosity of the distal segment greater than the porosity of the proximal segment, or vice versa. Method 900 may also include inserting the proximal segment into the central segment until the proximal segment is adjacent to or communicating with the neck of the aneurysm; and induce a flow deviation effect through the aneurysm neck.
    [0080] It is understood that variations of braid 10 can include various materials such as nitinol, stainless steel, bioabsorbable materials and polymers. The thread count of the interstices of the braid 10 that can form the expandable and invertible mesh can vary depending on the bag diameter of segment 12 and / or segments proximal to it and / or inverted inside it. For example, to induce the formation of the predetermined shape and intensity of the distal braid bag 10, the end 14 may be open and / or be able to allow sizing or adaptation to aneurysm A. For example, if the aneurysm is relatively small, the distal end 14 can close on itself, while in a larger aneurysm the same strand 10 would remain open. Other segments of strand 10, including segments 11 and 13, may vary from more pliable over or around the end 14 and less pliable over or around the end 16. The interstices of strand 10 can also form small openings for aneurysm occlusion .
    [0081] Braid 10, including any specific portions such as breaks, inflection points, porosities, flexibilities and / or corresponding bag (s), can be heat-adjusted to various configurations, such as spherical, oblong, shaped saddle, etc. With the purpose of shaping the initial sac to better match the morphology of the aneurysm. It is also understood that any bag formed by the braid 10 discussed herein can be spherical in shape as shown or any other shape, as needed or required, such as ellipsoidal, heart-shaped, ovoid, cylindrical, hemispherical or the like. In addition, the interstices of the braid 10 that form the bag may vary, or be selectively designed, in size or shape along its length, depending on how much of the braid 10 is caused to expand radially as the release tube 30 is moved distally. .
    [0082] 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.
    权利要求:
    Claims (20)
    [1]
    1. Braided to treat an aneurysm, in which the braid comprises a proximal end and a distal end, characterized by the fact that the braid comprises: a distal segment arranged around the distal end, in which the distal segment is operable to make transition from a retracted state within a microcatheter to a state positioned distal from the microcatheter, so that the distal segment expands radially to form a distal sac; a central segment in communication with the distal segment, in which the central segment is able to invert itself in the distal sac; and a proximal segment in communication with the central segment and arranged around the proximal end, in which the proximal segment is capable of being inserted into the central segment in the positioned state; wherein each of the proximal, distal and central segments comprises different porosity or different flexibility.
    [2]
    2. Braided, according to claim 1, characterized by the fact that it also comprises an inflection point arranged between the central segment and the distal segment, in which the proximal end is configured to be inserted into the distal bag in the positioned state until the central segment is inverted so that the inflection point is disposed adjacent to the neck of the aneurysm to induce a flow deviation effect.
    [3]
    3. Braided to treat an aneurysm, in which the braid comprises a proximal end and a distal end, characterized by the fact that the braid comprises: a distal segment arranged around the distal end, in which the distal segment is operable to make the transition from a retracted state within a microcatheter to a state positioned distal from the microcatheter, so that the distal segment expands radially to form a distal sac; and a proximal segment disposed around the proximal end, where the proximal segment is able to invert and be inserted into the distal sac.
    [4]
    4. Braided according to claim 3, characterized by the fact that the proximal segment comprises a greater porosity than a porosity of the distal segment.
    [5]
    5. Braided according to claim 4, characterized by the fact that the proximal end is configured to be inserted into the distal sac in the positioned state until a proximal end of the distal segment is arranged adjacent to the aneurysm neck to induce an effect of flow deviation.
    [6]
    6. Braided, according to claim 3, characterized by the fact that it also comprises: an inflection point arranged between the proximal and distal segments.
    [7]
    7. Braided according to claim 6, characterized by the fact that the proximal segment is configured to be inverted when the inflection point is distal from the microcatheter or is configured to be inverted by the inflection point when the braid has been translated distally for a predetermined distance.
    [8]
    8. Braided according to claim 3, characterized by the fact that the distal sac has a diameter at least twice as large as the microcatheter.
    [9]
    9. Braided, according to claim 3, characterized by the fact that it also comprises a central segment disposed between the proximal and distal segments.
    [10]
    10. Braided according to claim 9, characterized by the fact that each of the proximal, distal and central segments comprises a different porosity.
    [11]
    11. Braided, according to claim 10, characterized by the fact that the central segment comprises a porosity greater than a porosity of the proximal and distal segments; and in which the porosity of the distal segment is greater than the porosity of the proximal segment.
    [12]
    12. Braided, according to claim 10, characterized by the fact that it also comprises: a first inflection point arranged between the distal segment and the central segment; and a second inflection point arranged between the central segment and the proximal segment.
    [13]
    13. Braided according to claim 12, characterized by the fact that in the positioned state, the first point of inflection is configured to cause the proximal end of the distal segment to buckle when the braid is moved distally at a first distance; and in which, in the positioned state, the second inflection point is configured to cause the central segment to reverse to the distal segment when the strand is transferred distally a second distance.
    [14]
    14. Braided according to claim 12, characterized by the fact that in the positioned state, the first point of inflection is configured to cause the proximal end of the distal segment to buckle around the neck of the aneurysm; and where, in the positioned state, the second inflection point is configured to cause the central segment to reverse to the distal segment.
    [15]
    15. Braided according to claim 12, characterized by the fact that when the first inflection point is distal from the microcatheter, the first inflection point is configured to cause the proximal end of the distal segment to buckle around the neck aneurysm; when the second inflection point is distal from the microcatheter, the second inflection point is configured to cause the central segment to reverse to the distal segment and the proximal segment to insert itself into the central segment.
    [16]
    16. Braided, according to claim 12, characterized by the fact that the proximal and / or central segment are / are configured to be inserted into the distal sac in the positioned state until the first inflection point is adjacent to the neck of the aneurysm to induce a flow deviation effect.
    [17]
    17. Method for occluding an aneurysm, characterized by the fact that it comprises: selectively placing a braid over or adjacent to an aneurysm neck; slide the braid distally into the aneurysm; radially expand a distal segment of the braid to form a distal sac within the aneurysm, the distal sac being configured to occlude the aneurysm; slide the braid more distally into the aneurysm, thus buckling the distal segment buckle around the aneurysm neck; slide the strand more distally into the aneurysm, thus reversing a central segment of the strand in the distal segment; insert a proximal segment of the strand in the central segment; and release the braid inside the aneurysm.
    [18]
    18. Method, according to claim 17, characterized by the fact that it further comprises: inserting the proximal segment in the central segment until an inflection point between the distal segment and the central segment is adjacent or in communication with the aneurysm neck ; and induce a flow deviation effect through the aneurysm neck.
    [19]
    19. Method, according to claim 17, characterized by the fact that it also comprises: placing a first inflection point between the distal segment and the central segment; positioning a second inflection point between the central segment and the proximal segment; buckle the distal segment around the neck of the aneurysm, by the first point of inflection, when moving a proximal end of the braid distally at a first distance from the neck of the aneurysm; and inverting the central segment in the distal segment, by the second point of inflection, with the proximal end of the braid distally moving a second distance in relation to the neck of the aneurysm.
    [20]
    20. Method according to claim 19, characterized by the fact that the inversion of the central segment in the distal segment, by the second inflection point, causes the central segment to be inserted in the distal segment.
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    同族专利:
    公开号 | 公开日
    KR20190137007A|2019-12-10|
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    EP3574851A1|2019-12-04|
    CN110547841A|2019-12-10|
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    CA3044197A1|2019-11-30|
    CO2019005699A1|2020-11-30|
    MX2019006377A|2019-12-02|
    RU2019116175A|2020-11-27|
    TW202011898A|2020-04-01|
    AU2019203715A1|2019-12-19|
    IL266841D0|2019-08-29|
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    法律状态:
    2019-12-03| 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
    US15/993,903|US10939915B2|2018-05-31|2018-05-31|Aneurysm device and delivery system|
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