US20230017191A1 - Implant having an intrasaccular section and intravascular section - Google Patents
Implant having an intrasaccular section and intravascular section Download PDFInfo
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- US20230017191A1 US20230017191A1 US17/943,829 US202217943829A US2023017191A1 US 20230017191 A1 US20230017191 A1 US 20230017191A1 US 202217943829 A US202217943829 A US 202217943829A US 2023017191 A1 US2023017191 A1 US 2023017191A1
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- intravascular
- intrasaccular
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Images
Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
Definitions
- the present invention generally relates to medical instruments, and more particularly, to embolic implants for aneurysm therapy.
- Cranial aneurysms can be complicated and difficult to treat due to their proximity to critical brain tissues.
- Prior solutions have included endovascular treatment whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow.
- Current alternatives to endovascular or other surgical approaches can include intravascularly delivered treatment devices that fill the sac of the aneurysm with embolic material or block the entrance or neck of the aneurysm. Both approaches attempt to prevent blood flow into the aneurysm. When filling an aneurysm sac, the embolic material clots the blood, creating a thrombotic mass within the aneurysm.
- Treating certain aneurysm morphology can require ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density. Once implanted, the coils cannot easily be retracted or repositioned. Furthermore, embolic coils do not always effectively treat aneurysms as aneurysms treated with multiple coils often recanalize or compact because of poor coiling, lack of coverage across the aneurysm neck, blood flow, or large aneurysm size.
- tubular braided implants have the potential to easily, accurately, and safely treat an aneurysm or other arterio-venous malformation in a parent vessel without blocking flow into perforator vessels communicating with the parent vessel.
- tubular braided implants are a newer technology, and there is therefore capacity for improved geometries, configurations, delivery systems, etc. for the tubular braided implants.
- An example implant can have a tubular braid.
- the tubular braid can have an intrasaccular section, an intravascular section, a pinched section, and a predetermined shape.
- the intrasaccular section can have a sack and an opening.
- the pinched section can be positioned approximate the opening.
- the intravascular section can be substantially disk shaped and positioned to occlude the opening.
- the tubular braid can be movable from a collapsed shape sized to traverse a catheter to an implanted shape based at least in part on the predetermined shape.
- the intrasaccular section of the braid can be sized to be positioned within an aneurysm's sac and the intravascular section of the braid can be sized to appose a blood vessel wall approximate an aneurysm's neck.
- the tubular braid can have a first open end from which the intrasaccular section extends and a second open end from which the intravascular section extends.
- the intrasaccular section can have a first segment extending from the first open end to a first fold, a second segment encircled by the open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the pinched section.
- the first open end can have a diameter approximately equal to a maximum diameter of the second segment, and the second open end can have a diameter greater than the diameter of the first open end and the maximum diameter of the second segment.
- the intravascular section when the tubular braid is in the predetermined shape, the intravascular section extends across the first fold.
- the implant can also have a band affixed to the braid and positioned over the pinched section.
- the band can have a distal side from which the intrasaccular section of the braid extends and a proximal side from which the intravascular section of the braid extends.
- the implant can also have an expandable frame affixed to the band, movable from a collapsed configuration sized to traverse the catheter to a radially expanded configuration.
- the expandable frame can have a plurality of substantially petal shaped struts.
- the combination of the intrasaccular section of the braid, the intravascular section of the braid, and the expandable frame are sufficient to maintain a position of the implant in relation to the aneurysm.
- the combination of the intrasaccular section of the braid, and the intravascular section of the braid are sufficient to maintain a position of the implant in relation to the aneurysm.
- Another example implant can have a first braid having a first predetermined shape, a second braid having a second predetermined shape, and a band affixed to the first braid and the second braid.
- the first braid can have a sack having an opening.
- the second braid can be substantially disk shaped.
- the band can be positioned approximate the opening and the second braid can be positioned to occlude the opening.
- the first braid can be movable from a first collapsed shape sized to traverse a lumen of a microcatheter to a first deployed shape based at least in part on the first predetermined shape.
- the first braid can be sized to be positioned within an aneurysm's sac.
- the second braid can be movable from a second collapsed shape sized to traverse the lumen of the microcatheter to a second deployed shape based at least in part on the second predetermined shape.
- the second braid can be shaped to appose a blood vessel wall approximate an aneurysm's neck.
- the first braid can have a first open end.
- the first braid can have a first segment extending from the first open end to a first fold, a second segment encircled by the first open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the band.
- the first open end can have a diameter approximately equal to a maximum diameter of the second segment.
- the second braid can have a second open end having a diameter greater than the diameter of the first open end and the diameter of the second segment.
- the first braid can have a first braid angle and the second braid can have a second braid angle. The first braid angle can be different from the second braid angle.
- the second braid when the first braid is in the first predetermined shape and the second braid is in the second predetermined shape, the second braid can extend across the first fold.
- the example implant can have an expandable frame affixed to the band.
- the expandable frame can be movable from a collapsed configuration sized to traverse the lumen of the microcatheter to a radially expanded configuration.
- the expandable frame can have a plurality of substantially petal shaped struts. Further, in some examples, the combination of the first braid, the second braid, and the expandable frame can be sufficient to maintain a position of the implant in relation to an aneurysm. Alternatively, or additionally, a combination of the first braid and the second braid can be sufficient to maintain a position of the implant in relation to the aneurysm.
- An example method for inserting an implant into an aneurysm having an intrasaccular braided section and an intravascular braided section can include one or more of the following steps presented in no particular order, and the method can include additional steps not included here.
- the method can include selecting an implant having an intrasaccular braided section and an intravascular braided section affixed to the intrasaccular braided section such that the intravascular braided section and the intrasaccular braided section are each constricted where the two sections are affixed to each other.
- the implant can be collapsed to fit within a microcatheter.
- the method can include pushing the implant through a majority of the microcatheter.
- the intrasaccular braided section can be expanded to anchor within a sac of the aneurysm.
- the method can further include expanding the intravascular braided section to appose a blood vessel wall approximate a neck of the aneurysm.
- the method can further include maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section to appose the blood vessel wall without requiring an ancillary implant.
- the method can further include expanding the expandable frame to appose the blood vessel wall approximate the aneurysm's neck.
- the method can further include maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section within a blood vessel to appose the blood vessel wall.
- the intravascular braided section can include the expandable frame to appose the blood vessel wall without requiring an ancillary implant. Additionally, or alternatively, the method for maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section within the blood vessel to appose the blood vessel wall can be accomplished without the expandable frame.
- FIG. 1 A is an illustration of an example implant in a predetermined shape according to aspects of the present invention
- FIG. 1 B is an illustration of an example implant in an implanted shape according to aspects of the present invention.
- FIG. 1 C is an illustration of an example implant in an implanted shape according to aspects of the present invention.
- FIG. 1 D is an illustration of an example implant in a deformed shape according to aspects of the present invention.
- FIGS. 2 A to 2 F are illustrations of an implant having a tubular braid that expands to an implanted shape similar to as illustrated in FIG. 1 B as the tubular braid exits a microcatheter according to aspects of the present invention
- FIG. 3 A is an illustration of an example implant in an implanted shape according to aspects of the present invention.
- FIG. 3 B is an illustration of an example implant in a deformed shape according to aspects of the present invention.
- FIG. 3 C is a cross section of the example implant as indicated in FIG. 3 A according to aspects of the present invention.
- FIG. 4 A is an illustration of an example implant in an implanted shape according to aspects of the present invention.
- FIG. 4 B is an illustration of an example implant in an implanted shape according to aspects of the present invention.
- FIGS. 5 A and 5 B are illustrations of example braid types for an example implant according to aspects of the present invention.
- FIGS. 6 A and 6 B is an illustration of example braid angles for an example implant according to aspects of the present invention.
- FIG. 7 is a flow diagram outlining example method steps that can be carried out during deployment of an exemplary implant according to aspects of the present invention.
- Examples presented herein generally include a braided implant that can secure within an aneurysm sac and occlude a majority of the aneurysm's neck.
- the implant can include a tubular braid with an intravascular section and an intrasaccular section that can be set into a predetermined shape.
- the implant can be compressed for delivery through a microcatheter and implanted such that the intrasaccular section can be positioned within the sac of the aneurysm.
- the intravascular section can be positioned outside the sac of the aneurysm.
- the shapes of the intrasaccular section and the intravascular section are based on the predetermined shape and the geometry of the aneurysm in which the braid is implanted. When implanted, the intravascular section stabilizes the implant by securing it to the blood vessel walls.
- FIG. 1 A depicts a cross-sectional view of an exemplary implant in a predetermined shape.
- the implant can have a braid 110 that can include an intrasaccular section 111 and an intravascular section 136 .
- the intrasaccular section 111 and the intravascular section 136 can be constructed from a single braid 110 or a plurality of braids.
- the intrasaccular section 111 can include a pinched section 112 , an open end 114 , a first fold 116 , a second fold 118 , a braid lumen 119 , and a braid opening 126 .
- the intrasaccular section 111 can include a first segment 120 extending from the open end 114 to the first fold 116 , a second segment 122 extending from the first fold 116 to the second fold 118 , and a third segment 124 extending from the second fold 118 to the pinched section 112 .
- the third segment 124 can be surrounded by the second segment 122 .
- the third segment 124 can extend from the second fold 118 to the proximal end 138 of the intravascular section 136 .
- the intrasaccular section 111 can include a band 128 , a band lumen 130 , a distal side 134 of the band 128 , and a proximal side 132 of the band 128 .
- the band 128 can be disposed proximate the pinched section 112 of the braid 110 .
- the band 128 can be a weld or an adhesive.
- the braid 110 can be attached to the band lumen 130 .
- the braid 110 can pass through the band lumen 130 to form the intravascular section 136 .
- the braid lumen 119 can be attached to the distal side 134 of the band 128
- the distal end 140 of the intravascular section 136 can be attached to the proximal side 132 of the band 128 .
- the first segment 120 can have a diameter D1
- the second segment 122 can have a diameter D2
- the intravascular section 136 can have a diameter D3.
- the diameter D3 can be a measure from the distal end 140 of the intravascular section 136 to a proximal end 138 of the intravascular section 136 , the measure then multiplied by two.
- the diameter D3 of the intravascular section 136 can be greater than the diameter D1 of the first segment 120 .
- the diameter D2 of the second segment 122 can be less than the diameter D1 of the first segment 120 . In other words, D3>D1>D2.
- the diameter D2 can be approximately equal to the diameter D1.
- FIG. 1 B depicts a cross-sectional view of an exemplary implant in an implanted shape as indicated in FIG. 1 C .
- the implant 100 can include an intrasaccular section 111 and an intravascular section 136 .
- the intrasaccular section 111 can be positioned within a sac 12 of an aneurysm 10 and the intravascular section 136 can be positioned in vasculature 22 a , 22 b such that it occludes the neck 16 of the aneurysm 10 .
- the proximal end 138 of the intravascular section 136 can appose or anchor to the blood vessel wall 22 c .
- the intrasaccular section 111 can include an open end 114 , a pinched section 112 , a proximal fold 116 a , a distal fold 118 a , and a braid opening 126 a .
- a band 128 can be disposed proximate the pinched section 112 .
- the band 128 can have a distal side 134 , a proximal side 132 , and a band lumen 130 .
- the band 128 can be a weld or an adhesive.
- An outer layer 120 a extends from the open end 114 to the proximal fold 116 a .
- a middle layer 122 a extends from the proximal fold 116 a to the distal fold 118 a
- an inner layer 124 a extends from the distal fold 118 a to the pinched section 112 .
- the inner layer can extend from the distal fold 118 a to the proximal end 138 of the intravascular section 136 .
- the inner layer 124 a can extend from the distal fold 118 a to the pinched section 112 .
- the inner layer 124 a can be attached to the distal side 134 of the band 128 and another braid can begin at a distal end 140 of the intravascular section 136 can be attached to the proximal side 132 of the band 128 .
- FIG. 1 C depicts a cross-sectional view of the implant 100 in the implanted shape as indicated in FIG. 1 B .
- the intravascular section 136 secures itself by apposing or anchoring to the blood vessel wall 22 c .
- the intravascular section 136 extends beyond the aneurysm neck 16 and in doing so, provides greater stability to the intrasaccular section 111 positioned within the sac 12 of the aneurysm 10 .
- the intravascular section 136 can be sufficient to anchor the implant 100 in place.
- FIG. 1 D depicts an exemplary implant in a deformed shape.
- the implant 100 can include an intrasaccular section 111 and an intravascular section 136 .
- the implant 100 can be positioned in a deformed shape within a lumen 202 of a microcatheter 200 .
- the implant can be positioned such that the open end 114 of the implant 100 can be proximate a distal end 204 of the microcatheter 200 .
- FIGS. 2 A to 2 F depict an exemplary implant being deployed.
- the distal end 204 of the microcatheter 200 can be inserted through the stem vessel 20 and the implant 100 can be deployed by pushing the implant 100 out of the distal end 204 of the microcatheter 200 and into the sac 12 of the aneurysm 10 .
- the aneurysm 10 can be located on a blood vessel wall 22 c without the stem vessel 20 (e.g. a sidewall aneurysm).
- a blood vessel wall 22 c without the stem vessel 20 (e.g. a sidewall aneurysm).
- the distal end 204 of the microcatheter 200 can be slightly retracted in a proximal direction and more of the implant 100 can be pushed out of the distal end 204 of the microcatheter 200 .
- the braid 110 begins to contact the aneurysm wall 14 .
- the proximal fold 116 a and the outer layer 120 a begin to develop as the braid 110 continues to invert.
- the band 128 and the intravascular section 136 still remain within the lumen 202 of the microcatheter 200 .
- the band 128 can be a weld or an adhesive.
- the braid 110 continues to invert as the proximal fold 116 a and the outer layer 120 a become more defined.
- the middle layer 122 a begins to develop along with the distal fold 118 a and the inner layer 124 a .
- the band 128 and the intravascular section 136 are no longer within the lumen 202 of the microcatheter 200 .
- the band 128 can be a weld or an adhesive.
- the intravascular section 136 having a proximal end 138 blooms to occlude the neck 16 and provide greater stability to the intrasaccular section 111 of the implant 100 positioned within the sac 12 .
- the proximal end 138 of the intravascular section 136 stabilizes and secures the implant 100 by applying pressure to the blood vessel wall 22 c .
- the microcatheter 200 can be retracted from the stem vessel 20 .
- FIG. 3 A depicts a cross-sectional view of an exemplary implant utilizing an expandable frame 142 .
- implant 100 a can include an intravascular section 136 .
- the intravascular section 136 can include an expandable frame 142 .
- the expandable frame 142 can provide additional stability to the implant 100 a by providing a reinforcing structure to the intravascular section 136 .
- the expandable frame 142 can include one or more petals 144 constructed from nitinol. Alternatively, or additionally, the expandable frame 142 can be constructed from platinum wire.
- FIG. 3 B depicts the implant 100 a in a deformed shape
- the implant 100 a can include an intravascular section 136 having an expandable frame 142 .
- the implant 100 a is illustrated in a collapsed, delivery configuration within the lumen 202 of the microcatheter 200 such that the open end 114 of the implant 100 a can be proximate the distal end 204 of the microcatheter 200 .
- FIG. 3 C depicts a cross-sectional view of the implant 100 a as indicated in FIG. 3 A .
- FIG. 4 A depicts a cross-sectional view of another exemplary implant 100 b utilizing an expandable frame.
- implant 100 b can include an intravascular section 136 .
- the intravascular section 136 can include an expandable frame 142 a .
- the expandable frame 142 a can provide additional stability to the implant 100 b by providing a reinforcing structure to the intravascular section 136 .
- the expandable frame 142 a can include one or more petals 144 a constructed from nitinol. Alternatively, or additionally, the expandable frame 142 a can be constructed from platinum wire. Further, one or more inner petals 146 can be positioned within the one or more petals 144 a.
- FIG. 4 B depicts a cross-sectional view of another exemplary implant 100 c utilizing an expandable frame 142 b .
- implant 100 c can include an intravascular section 136 .
- the intravascular section 136 can include an expandable frame 142 b .
- the expandable frame 142 b can provide additional stability to the implant 100 c by providing a reinforcing structure to the intravascular section 136 .
- the expandable frame 142 b can include one or more petals 144 b constructed from nitinol. Additionally, or alternatively, the expandable frame 142 b can include one or more petals 144 b constructed from platinum wire.
- the one or more petals 144 b can further include radiopaque markers 148 disposed on the one or more petals 144 b.
- FIGS. 5 A and 5 B depict examples of different weaves 500 that can be employed in constructing the braid 110 .
- FIG. 5 A illustrates a barbed weave that can have strands 501 and sharp tips 502 by virtue of the ends of the braid 110 being cut. These sharp tips 502 can pierce or prick at the blood vessel wall 22 c or the aneurysm wall 14 and can potentially destabilize the aneurysm 10 leading to a rupture.
- FIG. 5 B illustrates an atraumatic weave 504 that can include blunt tips 506 that can reduce the ability for the braid 110 to pierce the aneurysm wall 16 or the blood vessel wall 22 c .
- the blunt tips 506 can be formed by bending or folding the strands 501 at the end of the braid 110 , instead of simply cutting the strands 501 as discussed above in FIG. 5 A .
- FIGS. 6 A and 6 B depict an exemplary implant 100 d having a braid 110 configured to have one or more braid angles, for example, braid angles ⁇ 1, ⁇ 2, ⁇ 3, and ⁇ 4 which can be measured by comparing the tangential trajectory of a braid strand to the central axis A, as illustrated, and as would otherwise be understood by a person of ordinary skill in the art according to the teachings herein.
- a contiguous braided portion can include sections having different braid angles. For instance, a braid can be wrapped around a mandrel.
- a braid having a variable braid angle can otherwise be formed as appreciated and understood by a person of ordinary skill in the art.
- Braid strands can be woven such that about half of the strands wrap in a clockwise helix, the other half wraps in a counterclockwise helix, and the oppositely wrapping strands cross over and under each other in an alternating fashion. Constructed as such, portions of the braid having a higher braid angle can therefore having a higher density of strands compared to portions of the braid having lower braid angle. Higher strand density can result in a denser, stiffer braid portion.
- the braid 110 can include a number of strands, each extending from the open end 114 to the proximal end 140 of the intravascular section 136 and helically wrapping about the circumference C.
- the braid 110 can include a first set of strands, each extending from the open end 114 to the band 128 , and a second set of strands extending from the band 128 to the proximal end 140 of the intravascular section 136 and helically wrapping about the circumference C.
- the band 128 can be a weld or an adhesive. As illustrated in FIG.
- the first set of strands can have one or more first braid angles ⁇ 1, ⁇ 2, ⁇ 3, and the second set of strands can one or more second braid angles ⁇ 4.
- the braid angle ⁇ 4 of the intravascular section 136 can be less than braid angles ⁇ 1 or ⁇ 3 of the intrasaccular section 111 to reduce foreshortening of the intravascular section 136 when the intravascular section 136 exits the distal end 204 of the microcatheter 200 .
- braid angle ⁇ 2 can also have a braid angle less than braid angles ⁇ 1 or ⁇ 3. The reduction in foreshortening is advantageous because it can make the implant 100 d easier to control.
- the intrasaccular section 111 can have at least one braid angle ⁇ 5.
- Braid angle ⁇ 5 can be associated with the first segment 120 , the second segment 122 , and the third segment 124 .
- the intravascular section 136 can have a braid angle ⁇ 6.
- braid angles ⁇ 5 can have a higher braid angle than braid angle ⁇ 6. This can allow the intravascular section 136 to be easier to control during placement.
- a properly positioned intravascular section 136 can function as a better anchor for the implant 100 d compared to a foreshortened section 136 . Further, since the first segment 120 can also be stiffer than second segment 122 and the third segment 124 , the first segment 120 can also behave as an anchor for the implant 100 d . It is envisioned that the features described in relation to FIGS. 6 A and 6 B can be combinable with other exemplary implants 100 , 100 a , 100 b , 100 c as illustrated and described throughout herein.
- FIG. 7 illustrates an example method 700 for deploying an exemplary implant into an aneurysm as presented herein, variations thereof, or alternatives thereof as would be appreciated and understood by a person of ordinary skill in the art.
- the method 700 can include selecting an implant 100 b having an intrasaccular section 111 and an intravascular section 136 affixed to the intrasaccular section 111 such that the intravascular section 136 and the intrasaccular section 111 are each constricted where the two sections are affixed to each other.
- the implant 100 b can be collapsed to fit within a lumen 202 of a microcatheter 200 .
- the method 700 can include pushing the implant 100 b through the lumen 202 of the microcatheter 200 .
- the intrasaccular section 111 can be expanded to anchor within a sac 12 of the aneurysm 10 .
- the method 700 can further include expanding the intravascular section 136 to appose a blood vessel wall 22 c approximate a neck 14 of the aneurysm 10 .
- the method 700 can further include expanding the expandable frame 142 a to appose the blood vessel wall 22 c approximate the aneurysm's neck 14 .
- the method 700 can further include maintaining the intrasaccular section 111 within the aneurysm's sac 12 and the intravascular section 136 to appose the blood vessel wall 22 c without requiring an ancillary implant.
- the method 700 can additionally, or alternatively, include maintaining the intrasaccular section 111 within the aneurysm's sac 12 , the intravascular section 136 to appose the blood vessel wall 22 c , and the expandable frame 142 a to appose the blood vessel wall 22 c without requiring an ancillary implant.
- the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.
- tubular and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length.
- the tubular structure or system is generally illustrated as a substantially right cylindrical structure.
- the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
- the invention contemplates many variations and modifications of the implant system, including alternative geometries of elements and components described herein, alternative braid shapes, utilizing one or more of several means for braiding, knitting, weaving, or otherwise forming the braid, utilizing alternative materials for each component or element (e.g. radiopaque materials, memory shape materials, polymers, metals, etc.), utilizing additional components to perform functions described herein or not described herein as would be apparent to those having ordinary skill in the art to which this invention relates. Such variations and modifications are intended to be within the scope of the claims which follow.
Abstract
An example implant can have a tubular braid. The tubular braid can have an intrasaccular section, an intravascular section, a pinched section, and a predetermined shape. In the predetermined shape, the intrasaccular section can have a sack and an opening. The pinched section can be positioned approximate the opening. The intravascular section can be substantially disk shaped and positioned to occlude the opening. The tubular braid can be movable from a collapsed shape sized to traverse a catheter to an implanted shape based at least in part on the predetermined shape. In the implanted shape, the intrasaccular section of the braid can be sized to be positioned within an aneurysm's sac and the intravascular section of the braid can be sized to appose a blood vessel wall approximate an aneurysm's neck.
Description
- The present application is a continuation application of U.S. patent application Ser. No. 16/718,912 filed Dec. 18, 2019. The entire contents of which are hereby incorporated by reference.
- The present invention generally relates to medical instruments, and more particularly, to embolic implants for aneurysm therapy.
- Cranial aneurysms can be complicated and difficult to treat due to their proximity to critical brain tissues. Prior solutions have included endovascular treatment whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow. Current alternatives to endovascular or other surgical approaches can include intravascularly delivered treatment devices that fill the sac of the aneurysm with embolic material or block the entrance or neck of the aneurysm. Both approaches attempt to prevent blood flow into the aneurysm. When filling an aneurysm sac, the embolic material clots the blood, creating a thrombotic mass within the aneurysm. When treating the aneurysm neck, blood flow into the entrance of the aneurysm is inhibited, inducing venous stasis in the aneurysm and facilitating a natural formation of a thrombotic mass within the aneurysm.
- Current intravascularly delivered devices typically utilize multiple embolic coils to either fill the sac or treat the entrance of the aneurysm. Naturally formed thrombotic masses formed by treating the entrance with embolic coils can result in improved healing compared to aneurysm masses packed with embolic coils because naturally formed thrombotic masses can reduce the likelihood of distention from arterial walls and facilitate reintegration into the original parent vessel shape along the neck plane. However, embolic coils delivered to the neck of the aneurysm can potentially have the adverse effect of impeding the flow of blood in the adjoining blood vessel, particularly if the entrance is overpacked. Conversely, if the entrance is insufficiently packed, blood flow can persist into the aneurysm. Treating certain aneurysm morphology (e.g. wide neck, bifurcation, etc.) can require ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density. Once implanted, the coils cannot easily be retracted or repositioned. Furthermore, embolic coils do not always effectively treat aneurysms as aneurysms treated with multiple coils often recanalize or compact because of poor coiling, lack of coverage across the aneurysm neck, blood flow, or large aneurysm size.
- Alternatives to embolic coils are being explored, for example a tubular braided implant is disclosed in US Patent Publication Number 2018/0242979, which prior application is hereby incorporated herein by reference in its entirety herein into this application as if set forth in full. Tubular braided implants have the potential to easily, accurately, and safely treat an aneurysm or other arterio-venous malformation in a parent vessel without blocking flow into perforator vessels communicating with the parent vessel. Compared to embolic coils, however, tubular braided implants are a newer technology, and there is therefore capacity for improved geometries, configurations, delivery systems, etc. for the tubular braided implants.
- Applicants therefore recognize a need for improved methods, devices, and systems for implants for aneurysm treatment.
- It is an object of the present invention to provide systems, devices, and methods to meet the above-stated needs.
- An example implant can have a tubular braid. The tubular braid can have an intrasaccular section, an intravascular section, a pinched section, and a predetermined shape. In the predetermined shape, the intrasaccular section can have a sack and an opening. The pinched section can be positioned approximate the opening. The intravascular section can be substantially disk shaped and positioned to occlude the opening. The tubular braid can be movable from a collapsed shape sized to traverse a catheter to an implanted shape based at least in part on the predetermined shape. In the implanted shape, the intrasaccular section of the braid can be sized to be positioned within an aneurysm's sac and the intravascular section of the braid can be sized to appose a blood vessel wall approximate an aneurysm's neck.
- In some examples, the tubular braid can have a first open end from which the intrasaccular section extends and a second open end from which the intravascular section extends. Further, in the predetermined shape, the intrasaccular section can have a first segment extending from the first open end to a first fold, a second segment encircled by the open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the pinched section.
- In some examples, when the tubular braid is in the predetermined shape, the first open end can have a diameter approximately equal to a maximum diameter of the second segment, and the second open end can have a diameter greater than the diameter of the first open end and the maximum diameter of the second segment.
- In some examples, when the tubular braid is in the predetermined shape, the intravascular section extends across the first fold.
- In some examples, the implant can also have a band affixed to the braid and positioned over the pinched section. The band can have a distal side from which the intrasaccular section of the braid extends and a proximal side from which the intravascular section of the braid extends.
- In some examples, the implant can also have an expandable frame affixed to the band, movable from a collapsed configuration sized to traverse the catheter to a radially expanded configuration. Further, the expandable frame can have a plurality of substantially petal shaped struts.
- In some examples, the combination of the intrasaccular section of the braid, the intravascular section of the braid, and the expandable frame are sufficient to maintain a position of the implant in relation to the aneurysm. Alternatively, or additionally, the combination of the intrasaccular section of the braid, and the intravascular section of the braid, are sufficient to maintain a position of the implant in relation to the aneurysm.
- Another example implant can have a first braid having a first predetermined shape, a second braid having a second predetermined shape, and a band affixed to the first braid and the second braid. In the first predetermined shape, the first braid can have a sack having an opening. In the second predetermined shape, the second braid can be substantially disk shaped. When the first braid is in the first predetermined shape and the second braid is in the second predetermined shape, the band can be positioned approximate the opening and the second braid can be positioned to occlude the opening. Further, the first braid can be movable from a first collapsed shape sized to traverse a lumen of a microcatheter to a first deployed shape based at least in part on the first predetermined shape. In the first deployed shape, the first braid can be sized to be positioned within an aneurysm's sac. The second braid can be movable from a second collapsed shape sized to traverse the lumen of the microcatheter to a second deployed shape based at least in part on the second predetermined shape. In the second deployed shape, the second braid can be shaped to appose a blood vessel wall approximate an aneurysm's neck.
- In some examples, the first braid can have a first open end. In the first predetermined shape, the first braid can have a first segment extending from the first open end to a first fold, a second segment encircled by the first open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the band.
- In some examples, when the first braid is in the first predetermined shape, the first open end can have a diameter approximately equal to a maximum diameter of the second segment. When the second braid is in the second predetermined shape, the second braid can have a second open end having a diameter greater than the diameter of the first open end and the diameter of the second segment. Further, the first braid can have a first braid angle and the second braid can have a second braid angle. The first braid angle can be different from the second braid angle.
- In some examples, when the first braid is in the first predetermined shape and the second braid is in the second predetermined shape, the second braid can extend across the first fold.
- In some examples, the example implant can have an expandable frame affixed to the band. The expandable frame can be movable from a collapsed configuration sized to traverse the lumen of the microcatheter to a radially expanded configuration.
- In some examples, the expandable frame can have a plurality of substantially petal shaped struts. Further, in some examples, the combination of the first braid, the second braid, and the expandable frame can be sufficient to maintain a position of the implant in relation to an aneurysm. Alternatively, or additionally, a combination of the first braid and the second braid can be sufficient to maintain a position of the implant in relation to the aneurysm.
- An example method for inserting an implant into an aneurysm having an intrasaccular braided section and an intravascular braided section can include one or more of the following steps presented in no particular order, and the method can include additional steps not included here. The method can include selecting an implant having an intrasaccular braided section and an intravascular braided section affixed to the intrasaccular braided section such that the intravascular braided section and the intrasaccular braided section are each constricted where the two sections are affixed to each other. Further, the implant can be collapsed to fit within a microcatheter. The method can include pushing the implant through a majority of the microcatheter. Further, the intrasaccular braided section can be expanded to anchor within a sac of the aneurysm. The method can further include expanding the intravascular braided section to appose a blood vessel wall approximate a neck of the aneurysm.
- In some examples, the method can further include maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section to appose the blood vessel wall without requiring an ancillary implant.
- In some examples, the method can further include expanding the expandable frame to appose the blood vessel wall approximate the aneurysm's neck.
- In some examples, the method can further include maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section within a blood vessel to appose the blood vessel wall. The intravascular braided section can include the expandable frame to appose the blood vessel wall without requiring an ancillary implant. Additionally, or alternatively, the method for maintaining both the intrasaccular braided section within the aneurysm's sac and the intravascular braided section within the blood vessel to appose the blood vessel wall can be accomplished without the expandable frame.
- The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
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FIG. 1A is an illustration of an example implant in a predetermined shape according to aspects of the present invention; -
FIG. 1B is an illustration of an example implant in an implanted shape according to aspects of the present invention; -
FIG. 1C is an illustration of an example implant in an implanted shape according to aspects of the present invention; -
FIG. 1D is an illustration of an example implant in a deformed shape according to aspects of the present invention; -
FIGS. 2A to 2F are illustrations of an implant having a tubular braid that expands to an implanted shape similar to as illustrated inFIG. 1B as the tubular braid exits a microcatheter according to aspects of the present invention; -
FIG. 3A is an illustration of an example implant in an implanted shape according to aspects of the present invention; -
FIG. 3B is an illustration of an example implant in a deformed shape according to aspects of the present invention; -
FIG. 3C is a cross section of the example implant as indicated inFIG. 3A according to aspects of the present invention; -
FIG. 4A is an illustration of an example implant in an implanted shape according to aspects of the present invention; -
FIG. 4B is an illustration of an example implant in an implanted shape according to aspects of the present invention; -
FIGS. 5A and 5B are illustrations of example braid types for an example implant according to aspects of the present invention; -
FIGS. 6A and 6B is an illustration of example braid angles for an example implant according to aspects of the present invention; and -
FIG. 7 is a flow diagram outlining example method steps that can be carried out during deployment of an exemplary implant according to aspects of the present invention. - Examples presented herein generally include a braided implant that can secure within an aneurysm sac and occlude a majority of the aneurysm's neck. The implant can include a tubular braid with an intravascular section and an intrasaccular section that can be set into a predetermined shape. Furthermore, the implant can be compressed for delivery through a microcatheter and implanted such that the intrasaccular section can be positioned within the sac of the aneurysm. The intravascular section can be positioned outside the sac of the aneurysm. The shapes of the intrasaccular section and the intravascular section are based on the predetermined shape and the geometry of the aneurysm in which the braid is implanted. When implanted, the intravascular section stabilizes the implant by securing it to the blood vessel walls.
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FIG. 1A depicts a cross-sectional view of an exemplary implant in a predetermined shape. As illustrated, the implant can have abraid 110 that can include an intrasaccular section 111 and anintravascular section 136. The intrasaccular section 111 and theintravascular section 136 can be constructed from asingle braid 110 or a plurality of braids. The intrasaccular section 111 can include apinched section 112, anopen end 114, afirst fold 116, asecond fold 118, a braid lumen 119, and abraid opening 126. Further, the intrasaccular section 111 can include afirst segment 120 extending from theopen end 114 to thefirst fold 116, asecond segment 122 extending from thefirst fold 116 to thesecond fold 118, and athird segment 124 extending from thesecond fold 118 to thepinched section 112. Thethird segment 124 can be surrounded by thesecond segment 122. Alternatively, thethird segment 124 can extend from thesecond fold 118 to theproximal end 138 of theintravascular section 136. Further, the intrasaccular section 111 can include aband 128, aband lumen 130, adistal side 134 of theband 128, and aproximal side 132 of theband 128. Theband 128 can be disposed proximate thepinched section 112 of thebraid 110. In some examples, theband 128 can be a weld or an adhesive. Thebraid 110 can be attached to theband lumen 130. Where the intrasaccular section 111 and theintravascular section 136 are constructed from thesame braid 110, thebraid 110 can pass through theband lumen 130 to form theintravascular section 136. Alternatively, where the intrasaccular section 111 and theintravascular section 136 are constructed from independent braids, the braid lumen 119 can be attached to thedistal side 134 of theband 128, and thedistal end 140 of theintravascular section 136 can be attached to theproximal side 132 of theband 128. Thefirst segment 120 can have a diameter D1, thesecond segment 122 can have a diameter D2, and theintravascular section 136 can have a diameter D3. The diameter D3 can be a measure from thedistal end 140 of theintravascular section 136 to aproximal end 138 of theintravascular section 136, the measure then multiplied by two. The diameter D3 of theintravascular section 136 can be greater than the diameter D1 of thefirst segment 120. The diameter D2 of thesecond segment 122 can be less than the diameter D1 of thefirst segment 120. In other words, D3>D1>D2. Alternatively, the diameter D2 can be approximately equal to the diameter D1. -
FIG. 1B depicts a cross-sectional view of an exemplary implant in an implanted shape as indicated inFIG. 1C . As illustrated, theimplant 100 can include an intrasaccular section 111 and anintravascular section 136. The intrasaccular section 111 can be positioned within asac 12 of ananeurysm 10 and theintravascular section 136 can be positioned invasculature 22 a, 22 b such that it occludes theneck 16 of theaneurysm 10. Theproximal end 138 of theintravascular section 136 can appose or anchor to theblood vessel wall 22 c. Since theimplant 100 is constrained by theaneurysm wall 14 andblood vessel wall 22 c, the implanted shape, as illustrated, can be distorted from the predetermined shape, as discussed inFIG. 1A above. The intrasaccular section 111 can include anopen end 114, apinched section 112, a proximal fold 116 a, adistal fold 118 a, and a braid opening 126 a. Aband 128 can be disposed proximate thepinched section 112. Theband 128 can have adistal side 134, aproximal side 132, and aband lumen 130. In some examples, theband 128 can be a weld or an adhesive. Anouter layer 120 a extends from theopen end 114 to the proximal fold 116 a. A middle layer 122 a extends from the proximal fold 116 a to thedistal fold 118 a, and an inner layer 124 a extends from thedistal fold 118 a to thepinched section 112. Alternatively, or additionally, when the intrasaccular section 111 and theintravascular section 136 are constructed from asingle braid 110, the inner layer can extend from thedistal fold 118 a to theproximal end 138 of theintravascular section 136. Alternatively, or additionally, when the intrasaccular section 111 and theintravascular section 136 are constructed from a plurality of braids, the inner layer 124 a can extend from thedistal fold 118 a to thepinched section 112. Further, when independent braids are utilized, the inner layer 124 a can be attached to thedistal side 134 of theband 128 and another braid can begin at adistal end 140 of theintravascular section 136 can be attached to theproximal side 132 of theband 128. -
FIG. 1C depicts a cross-sectional view of theimplant 100 in the implanted shape as indicated inFIG. 1B . As illustrated, theintravascular section 136 secures itself by apposing or anchoring to theblood vessel wall 22 c. Note that theintravascular section 136 extends beyond theaneurysm neck 16 and in doing so, provides greater stability to the intrasaccular section 111 positioned within thesac 12 of theaneurysm 10. Theintravascular section 136 can be sufficient to anchor theimplant 100 in place. -
FIG. 1D depicts an exemplary implant in a deformed shape. As illustrated, theimplant 100 can include an intrasaccular section 111 and anintravascular section 136. Theimplant 100 can be positioned in a deformed shape within alumen 202 of amicrocatheter 200. The implant can be positioned such that theopen end 114 of theimplant 100 can be proximate adistal end 204 of themicrocatheter 200. -
FIGS. 2A to 2F depict an exemplary implant being deployed. As illustrated, inFIG. 2A , thedistal end 204 of themicrocatheter 200 can be inserted through thestem vessel 20 and theimplant 100 can be deployed by pushing theimplant 100 out of thedistal end 204 of themicrocatheter 200 and into thesac 12 of theaneurysm 10. Alternatively, or additionally, theaneurysm 10 can be located on ablood vessel wall 22 c without the stem vessel 20 (e.g. a sidewall aneurysm). InFIG. 2B , thedistal end 204 of themicrocatheter 200 can be slightly retracted in a proximal direction and more of theimplant 100 can be pushed out of thedistal end 204 of themicrocatheter 200. Note, that thebraid 110 begins to contact theaneurysm wall 14. InFIG. 2C , the proximal fold 116 a and theouter layer 120 a begin to develop as thebraid 110 continues to invert. Theband 128 and theintravascular section 136 still remain within thelumen 202 of themicrocatheter 200. In some examples, theband 128 can be a weld or an adhesive. InFIG. 2D , thebraid 110 continues to invert as the proximal fold 116 a and theouter layer 120 a become more defined. InFIG. 2E , as thebraid 110 continues to invert, the middle layer 122 a begins to develop along with thedistal fold 118 a and the inner layer 124 a. InFIG. 2F , theband 128 and theintravascular section 136 are no longer within thelumen 202 of themicrocatheter 200. In some examples, theband 128 can be a weld or an adhesive. Theintravascular section 136 having aproximal end 138 blooms to occlude theneck 16 and provide greater stability to the intrasaccular section 111 of theimplant 100 positioned within thesac 12. Theproximal end 138 of theintravascular section 136 stabilizes and secures theimplant 100 by applying pressure to theblood vessel wall 22 c. Themicrocatheter 200 can be retracted from thestem vessel 20. -
FIG. 3A depicts a cross-sectional view of an exemplary implant utilizing anexpandable frame 142. As illustrated, implant 100 a can include anintravascular section 136. Theintravascular section 136 can include anexpandable frame 142. Theexpandable frame 142 can provide additional stability to the implant 100 a by providing a reinforcing structure to theintravascular section 136. Theexpandable frame 142 can include one ormore petals 144 constructed from nitinol. Alternatively, or additionally, theexpandable frame 142 can be constructed from platinum wire. -
FIG. 3B depicts the implant 100 a in a deformed shape, the implant 100 a can include anintravascular section 136 having anexpandable frame 142. The implant 100 a is illustrated in a collapsed, delivery configuration within thelumen 202 of themicrocatheter 200 such that theopen end 114 of the implant 100 a can be proximate thedistal end 204 of themicrocatheter 200. -
FIG. 3C depicts a cross-sectional view of the implant 100 a as indicated inFIG. 3A . -
FIG. 4A depicts a cross-sectional view of anotherexemplary implant 100 b utilizing an expandable frame. As illustrated,implant 100 b can include anintravascular section 136. Theintravascular section 136 can include an expandable frame 142 a. The expandable frame 142 a can provide additional stability to theimplant 100 b by providing a reinforcing structure to theintravascular section 136. The expandable frame 142 a can include one ormore petals 144 a constructed from nitinol. Alternatively, or additionally, the expandable frame 142 a can be constructed from platinum wire. Further, one or moreinner petals 146 can be positioned within the one ormore petals 144 a. -
FIG. 4B depicts a cross-sectional view of anotherexemplary implant 100 c utilizing anexpandable frame 142 b. As illustrated,implant 100 c can include anintravascular section 136. Theintravascular section 136 can include anexpandable frame 142 b. Theexpandable frame 142 b can provide additional stability to theimplant 100 c by providing a reinforcing structure to theintravascular section 136. Theexpandable frame 142 b can include one ormore petals 144 b constructed from nitinol. Additionally, or alternatively, theexpandable frame 142 b can include one ormore petals 144 b constructed from platinum wire. The one ormore petals 144 b can further includeradiopaque markers 148 disposed on the one ormore petals 144 b. -
FIGS. 5A and 5B depict examples of different weaves 500 that can be employed in constructing thebraid 110.FIG. 5A , for example, illustrates a barbed weave that can havestrands 501 andsharp tips 502 by virtue of the ends of thebraid 110 being cut. Thesesharp tips 502 can pierce or prick at theblood vessel wall 22 c or theaneurysm wall 14 and can potentially destabilize theaneurysm 10 leading to a rupture. In contrast,FIG. 5B illustrates anatraumatic weave 504 that can includeblunt tips 506 that can reduce the ability for thebraid 110 to pierce theaneurysm wall 16 or theblood vessel wall 22 c. Theblunt tips 506 can be formed by bending or folding thestrands 501 at the end of thebraid 110, instead of simply cutting thestrands 501 as discussed above inFIG. 5A . -
FIGS. 6A and 6B depict an exemplary implant 100 d having abraid 110 configured to have one or more braid angles, for example, braid angles θ1, θ2, θ3, and θ4 which can be measured by comparing the tangential trajectory of a braid strand to the central axis A, as illustrated, and as would otherwise be understood by a person of ordinary skill in the art according to the teachings herein. A contiguous braided portion can include sections having different braid angles. For instance, a braid can be wrapped around a mandrel. While the wires are woven around the mandrel, the mandrel can move at a variable speed, with a faster moving mandrel resulting in a lower braid angle and the mandrel moving at a slower speed resulting in a higher braid angle. A braid having a variable braid angle can otherwise be formed as appreciated and understood by a person of ordinary skill in the art. Braid strands can be woven such that about half of the strands wrap in a clockwise helix, the other half wraps in a counterclockwise helix, and the oppositely wrapping strands cross over and under each other in an alternating fashion. Constructed as such, portions of the braid having a higher braid angle can therefore having a higher density of strands compared to portions of the braid having lower braid angle. Higher strand density can result in a denser, stiffer braid portion. - The
braid 110 can include a number of strands, each extending from theopen end 114 to theproximal end 140 of theintravascular section 136 and helically wrapping about the circumference C. Alternatively, or additionally, thebraid 110 can include a first set of strands, each extending from theopen end 114 to theband 128, and a second set of strands extending from theband 128 to theproximal end 140 of theintravascular section 136 and helically wrapping about the circumference C. In some examples, theband 128 can be a weld or an adhesive. As illustrated inFIG. 6A , the first set of strands can have one or more first braid angles θ1, θ2, θ3, and the second set of strands can one or more second braid angles θ4. The braid angle θ4 of theintravascular section 136 can be less than braid angles θ1 or θ3 of the intrasaccular section 111 to reduce foreshortening of theintravascular section 136 when theintravascular section 136 exits thedistal end 204 of themicrocatheter 200. Further, braid angle θ2 can also have a braid angle less than braid angles θ1 or θ3. The reduction in foreshortening is advantageous because it can make the implant 100 d easier to control. As discussed above, segments having a higher braid angle θ1, θ3 can be stiffer than segments having a lower braid angle θ2, θ4 resulting in a better anchor for the implant 100 d. Alternatively, or additionally, as illustrated inFIG. 6B , the intrasaccular section 111, can have at least one braid angle θ5. Braid angle θ5 can be associated with thefirst segment 120, thesecond segment 122, and thethird segment 124. Alternatively, or additionally, as illustrated inFIG. 6B , theintravascular section 136 can have a braid angle θ6. In some example, braid angles θ5 can have a higher braid angle than braid angle θ6. This can allow theintravascular section 136 to be easier to control during placement. A properly positionedintravascular section 136 can function as a better anchor for the implant 100 d compared to aforeshortened section 136. Further, since thefirst segment 120 can also be stiffer thansecond segment 122 and thethird segment 124, thefirst segment 120 can also behave as an anchor for the implant 100 d. It is envisioned that the features described in relation toFIGS. 6A and 6B can be combinable with otherexemplary implants -
FIG. 7 illustrates anexample method 700 for deploying an exemplary implant into an aneurysm as presented herein, variations thereof, or alternatives thereof as would be appreciated and understood by a person of ordinary skill in the art. - At
block 702, themethod 700 can include selecting animplant 100 b having an intrasaccular section 111 and anintravascular section 136 affixed to the intrasaccular section 111 such that theintravascular section 136 and the intrasaccular section 111 are each constricted where the two sections are affixed to each other. Atblock 704, theimplant 100 b can be collapsed to fit within alumen 202 of amicrocatheter 200. Atblock 706, themethod 700 can include pushing theimplant 100 b through thelumen 202 of themicrocatheter 200. Atblock 708, the intrasaccular section 111 can be expanded to anchor within asac 12 of theaneurysm 10. - At
block 710, themethod 700 can further include expanding theintravascular section 136 to appose ablood vessel wall 22 c approximate aneck 14 of theaneurysm 10. Themethod 700 can further include expanding the expandable frame 142 a to appose theblood vessel wall 22 c approximate the aneurysm'sneck 14. At block 712, themethod 700 can further include maintaining the intrasaccular section 111 within the aneurysm'ssac 12 and theintravascular section 136 to appose theblood vessel wall 22 c without requiring an ancillary implant. Themethod 700 can additionally, or alternatively, include maintaining the intrasaccular section 111 within the aneurysm'ssac 12, theintravascular section 136 to appose theblood vessel wall 22 c, and the expandable frame 142 a to appose theblood vessel wall 22 c without requiring an ancillary implant. - As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.
- When used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
- The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the implant system, including alternative geometries of elements and components described herein, alternative braid shapes, utilizing one or more of several means for braiding, knitting, weaving, or otherwise forming the braid, utilizing alternative materials for each component or element (e.g. radiopaque materials, memory shape materials, polymers, metals, etc.), utilizing additional components to perform functions described herein or not described herein as would be apparent to those having ordinary skill in the art to which this invention relates. Such variations and modifications are intended to be within the scope of the claims which follow.
Claims (15)
1. A method comprising:
selecting an implant comprising a tubular braid comprising an intrasaccular braided section and an intravascular braided section affixed to the intrasaccular braided section such that the intravascular braided section and the intrasaccular braided section are each constricted where the two sections are affixed to each other;
collapsing the implant to fit within a microcatheter;
pushing the implant through a majority of the microcatheter;
expanding the intrasaccular braided section to anchor within an aneurysm's sac; and
expanding the intravascular braided section to appose a blood vessel wall approximate an aneurysm's neck.
2. The method of claim 1 , further comprising:
maintaining the intrasaccular braided section within the aneurysm's sac and the intravascular braided section to appose the blood vessel wall without requiring an ancillary implant.
3. The method of claim 1 , wherein selecting the implant further comprises selecting the implant comprising an expandable frame, the method further comprising:
expanding the expandable frame to appose the blood vessel wall approximate the aneurysm's neck.
4. The method of claim 3 , further comprising:
maintaining the intrasaccular braided section within the aneurysm's sac, the intravascular braided section to appose the blood vessel wall, and the expandable frame to appose the blood vessel wall without requiring an ancillary implant.
5. The method of claim 1 , wherein the implant further comprises a pinched section, and a predetermined shape,
wherein, in the predetermined shape, the intrasaccular braided section comprises a sack comprising an opening, the pinched section is positioned approximate the opening, and the intravascular braided section is substantially disk shaped and positioned to occlude the opening,
wherein the tubular braid is movable from a collapsed shape sized to traverse a catheter to an implanted shape based at least in part on the predetermined shape, and
wherein, in the implanted shape, the intrasaccular braided section of the braid is sized to be positioned within an aneurysm's sac and the intravascular braided section of the braid is sized to appose a blood vessel wall approximate an aneurysm's neck,
wherein the tubular braid comprises a first open end from which the intrasaccular braided section extends and a second open end from which the intravascular braided section extends,
wherein, in the first predetermined shape, the intrasaccular braided section comprises a first segment extending from the first open end to a first fold, a second segment encircled by the first open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the pinched section, and
wherein the first fold is approximate the aneurysm's neck and the second fold is approximate a distal portion of the aneurysm's sac.
6. The method of claim 5 , wherein, when the tubular braid is in the predetermined shape, the first open end comprises a diameter, approximately equal to a maximum diameter of the second segment, and the second open end comprises a diameter greater than the diameter of the first open end and the maximum diameter of the second segment.
7. The method of claim 5 , wherein, when the tubular braid is in the predetermined shape, the intravascular braided section extends across the first fold.
8. The method of claim 5 , wherein the implant further comprises:
a band affixed to the tubular braid and positioned over the pinched section, the band comprising a distal side from which the intrasaccular braided section of the tubular braid extends and a proximal side from which the intravascular braided section of the tubular braid extends.
9. The method of claim 8 , wherein the implant further comprises:
an expandable frame affixed to the band, movable from a collapsed configuration sized to traverse the catheter to a radially expanded configuration.
10. The method of claim 9 , wherein the expandable frame comprises a plurality of substantially petal shaped struts.
11. The method of claim 1 , wherein the implant further comprises:
a band affixed to the intrasaccular braided section and the intravascular braided section,
wherein, in a first predetermined shape, the intrasaccular braided section comprises a sack comprising an opening,
wherein, in a second predetermined shape, the intravascular braided section is substantially disk shaped,
wherein, when the intrasaccular braided section is in the first predetermined shape and the second braid is in the second predetermined shape, the band is positioned approximate the opening and the intravascular braided section is positioned to occlude the opening,
wherein the intrasaccular braided section is movable from a first collapsed shape sized to traverse a lumen of a microcatheter to a first deployed shape based at least in part on the first predetermined shape,
wherein, in the first deployed shape, the intrasaccular braided section is sized to be positioned within an aneurysm's sac,
wherein the intravascular braided section is movable from a second collapsed shape sized to traverse the lumen of the microcatheter to a second deployed shape based at least in part on the second predetermined shape, and
wherein, in the second deployed shape, the intravascular braided section is shaped to appose a blood vessel wall approximate an aneurysm's neck,
wherein the intrasaccular braided section comprises a first open end,
wherein, in the first predetermined shape, the intrasaccular braided section comprises a first segment extending from the first open end to a first fold, a second segment encircled by the first open end and extending from the first fold to a second fold, and a third segment surrounded by the second segment and extending from the second fold to the band, and
wherein the first fold is approximate the aneurysm's neck and the second fold is approximate a distal portion of the aneurysm's sac.
12. The method of claim 11 ,
wherein, when the intrasaccular braided section is in the first predetermined shape, the first open end comprises a diameter, approximately equal to a maximum diameter of the second segment,
wherein, when the intravascular braided section is in the second predetermined shape, the intravascular braided section comprises a second open end comprising a diameter greater than the diameter of the first open end and the maximum diameter of the second segment,
wherein the intrasaccular braided section comprises a first braid angle,
wherein the intravascular braided section comprises a second braid angle, and
wherein the first braid angle different from the second braid angle.
13. The method of claim 11 , wherein, when the intrasaccular braided section is in the first predetermined shape and the intravascular braided section is in the second predetermined shape, the intravascular braided section extends across the first fold.
14. The method of claim 11 , wherein the implant further comprises:
an expandable frame affixed to the band, movable from a collapsed configuration sized to traverse the lumen of the microcatheter to a radially expanded configuration.
15. The method of claim 14 , wherein the expandable frame comprises a plurality of substantially petal shaped struts.
Priority Applications (1)
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US17/943,829 US20230017191A1 (en) | 2019-12-18 | 2022-09-13 | Implant having an intrasaccular section and intravascular section |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US16/718,912 US11457926B2 (en) | 2019-12-18 | 2019-12-18 | Implant having an intrasaccular section and intravascular section |
US17/943,829 US20230017191A1 (en) | 2019-12-18 | 2022-09-13 | Implant having an intrasaccular section and intravascular section |
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US16/718,912 Continuation US11457926B2 (en) | 2019-12-18 | 2019-12-18 | Implant having an intrasaccular section and intravascular section |
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US20230017191A1 true US20230017191A1 (en) | 2023-01-19 |
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US16/718,912 Active 2040-06-30 US11457926B2 (en) | 2019-12-18 | 2019-12-18 | Implant having an intrasaccular section and intravascular section |
US17/943,829 Abandoned US20230017191A1 (en) | 2019-12-18 | 2022-09-13 | Implant having an intrasaccular section and intravascular section |
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US16/718,912 Active 2040-06-30 US11457926B2 (en) | 2019-12-18 | 2019-12-18 | Implant having an intrasaccular section and intravascular section |
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EP (2) | EP3838186A3 (en) |
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-
2019
- 2019-12-18 US US16/718,912 patent/US11457926B2/en active Active
-
2020
- 2020-11-30 KR KR1020200164291A patent/KR20210078401A/en unknown
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KR20210078401A (en) | 2021-06-28 |
EP4026501A1 (en) | 2022-07-13 |
JP2021094382A (en) | 2021-06-24 |
CN112998797A (en) | 2021-06-22 |
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