US20210401439A1 - Intrasaccular device positioning and deployment system - Google Patents
- ️Thu Dec 30 2021
US20210401439A1 - Intrasaccular device positioning and deployment system - Google Patents
Intrasaccular device positioning and deployment system Download PDFInfo
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Publication number
- US20210401439A1 US20210401439A1 US17/470,049 US202117470049A US2021401439A1 US 20210401439 A1 US20210401439 A1 US 20210401439A1 US 202117470049 A US202117470049 A US 202117470049A US 2021401439 A1 US2021401439 A1 US 2021401439A1 Authority
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- United States Prior art keywords
- braided implant
- braided
- implant
- aneurysm
- delivery tube Prior art date
- 2018-09-25 Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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- 238000002513 implantation Methods 0.000 claims description 22
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- 238000011282 treatment Methods 0.000 abstract description 15
- 238000013459 approach Methods 0.000 description 6
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- 230000001732 thrombotic effect Effects 0.000 description 3
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- 229910052751 metal Inorganic materials 0.000 description 1
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Images
Classifications
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- 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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- A61B17/12168—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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- A61B2017/1205—Introduction devices
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12081—Details concerning the detachment of the occluding device from the introduction device detachable by inflation
Definitions
- the present invention generally relates to medical instruments, and more particularly, delivery systems for a device 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 occlusion devices that either fill the sac of the aneurysm with embolic material or treating 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.
- Naturally formed thrombotic masses formed by treating the entrance of the aneurysm with embolic coils can improve healing compared to aneurysm masses packed with embolic coils by reducing possible distention from arterial walls and permitting reintegration into the original parent vessel shape along the neck plane.
- 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; at the same time, if the entrance is insufficiently packed, blood flow can persist into the aneurysm.
- Properly implanting embolic coils is therefore challenging, and once implanted, the coils cannot easily be retracted or repositioned.
- embolic coils do not always effectively treat aneurysms as aneurysms treated with multiple coils often reanalyze or compact because of poor coiling, lack of coverage across the aneurysm neck, because of flow, or even aneurysm size.
- the devices generally can include a braided implant that can be detachably attached to a delivery tube by an expansion ring that can be positioned within a notch on an outer surface of the delivery tube near a distal end of the delivery tube.
- the implant can be positioned within a lumen of the delivery tube and remain attached to the delivery tube as the delivery tube and implant device assembly is fed through a microcatheter to a treatment site.
- the braided implant can be implanted by pushing an inner elongated member, or pusher distally, thereby pushing the braided implant out of the distal end of the delivery tube.
- the inner elongated member can be detachably attached to an end of the braided implant such that the braided implant can be retracted and repositioned until properly positioned, then released.
- the expansion ring can move from a collapsed configuration that is engaged with the notch of the delivery tube to a deployed configuration that releases the delivery tube. Once released, the delivery tube can be extracted from the patient, leaving behind the implanted braided implant.
- An example system for releasing an implant can include a braided implant, a delivery tube, an inner elongated member, and an expansion ring.
- the braided implant can have a first end detachably attached to a distal end of the inner elongated member and a second end mechanically connected to the expansion ring.
- the delivery tube can have a distal end with a notch positioned on an outer surface near the distal end of the delivery tube.
- the expansion ring can be movable from a collapsed configuration that is engaged with the notch to a deployed configuration that is disengaged from the notch and released from the delivery tube.
- the braided implant can include a fold positioned distal the distal end of the delivery tube, an outer fold segment extending proximally from the fold, and an inner fold segment extending proximally from the fold such that the outer fold segment encompasses the inner fold segment.
- the outer fold segment can include the second end of the braided implant attached to the expansion ring, and the inner fold segment can include the first end attached to the inner elongated member.
- the delivery tube can have a lumen therethrough and the inner fold segment of the braided implant can be positioned within the lumen.
- the expansion ring can be mechanically connected to a portion of the outer fold segment such that the outer fold segment covers at least a portion of the notch and at least a portion of the expansion ring.
- the expansion ring can include an attached segment and an extending portion.
- the attached segment can be attached to the braided implant and can open a first region of the occlusive sack to a first circumference
- the extending portion can be attached to the attaching segment and can open a second region of the occlusive sack to a second circumference greater than the first circumference.
- the expansion ring can have leaf shaped elements that extend radially as the expansion ring moves from the collapsed configuration to the deployed configuration.
- the expansion ring can have segments joined to form a substantially tubular zig-zag structure when in the collapsed configuration.
- the inner elongated member can be pushed distally to implant at least a portion of the braided implant.
- An example device for treating an aneurysm can include a tubular delivery member, an inner elongated member, a braided tubular implant, and an expansion component.
- the braided tubular implant can be movable from a delivery configuration to an implanted configuration.
- the braided tubular implant can have a first end extending proximally within an interior of the tubular delivery member that is detachably attached to a distal end of the inner elongated member and a second end extending distally from the distal end of the tubular delivery member and folding proximally over at least a portion of a notch positioned on an exterior of the tubular delivery member near a distal end of the tubular delivery member.
- the expansion component can be positioned within the notch on the tubular delivery member and attached to the braided tubular implant near the second end of the braided tubular implant.
- the expansion component can be movable from a collapsed configuration engaging the notch to a deployed configuration disengaging the notch.
- the notch on the exterior of the tubular delivery member can be a circumferential indentation.
- the expansion component can be positioned in the circumferential indentation when in the collapsed configuration.
- the braided tubular implant When in the implanted configuration, the braided tubular implant can have an occlusive sack and the expansion component can be positioned within the occlusive sack.
- the expansion component can have extending members that appose the occlusive sack when the expansion component is in the deployed configuration.
- the expansion component When in the collapsed configuration, the expansion component can have an opening through which the braided tubular implant passes through upon movement from the delivery configuration to the implanted configuration.
- An example method for treating an aneurysm can include the steps of providing a braided implantation delivery system having a braided implant, a delivery tube, and an expansion component, attaching the braided implant to the expansion component, engaging the expansion component with a notch on the delivery tube, implanting the braided implant in the aneurysm, expanding the expansion component to disengage the expansion component from the notch, and releasing the expansion component from the delivery tube which releases the braided implant from the delivery tube.
- the method can further include the step of expanding the expansion component to occlude at least a portion of the neck of the aneurysm.
- the step of implanting the braided implant in the aneurysm can include the step of forming an occlusive sack, and the step of expanding the expansion component can include the step of extending the occlusive sack across the neck of the aneurysm.
- the provided braided implantation delivery system can further include an inner elongated member, and the method can further include the step of attaching the braided implant to the inner elongated member.
- the step of implanting the braided implant can further include the steps of pushing the inner elongated member distally, thereby pushing a portion of the braided implant into the aneurysm and detaching the braided implant from the inner elongated member.
- FIG. 1 is a cross-sectional drawing of an implantation device or system according to the present invention
- FIG. 2A is a drawing depicting braided implant in a delivery configuration according to the present invention.
- FIG. 2B is a drawing depicting an expansion ring in a collapsed configuration according to the present invention.
- FIG. 2C is a drawing depicting a distal end of a delivery tube according to the present invention.
- FIG. 3 is a drawing depicting a distal end of an implantation system according to the present invention.
- FIG. 4 is a cross-sectional drawing of an implantation system within a microcatheter according to the present invention.
- FIGS. 5A to 5G are drawings illustrating a method of use of an implantation system according to the present invention.
- FIG. 6 is a drawing depicting a braided implant in an implanted configuration with an expansion ring in a deployed configuration according to the present invention
- FIG. 7A is a cut-away drawing of an aneurysm with a partially implanted braided implant.
- FIG. 7B is a cut-away drawing of an aneurysm with a completely implanted braided implant.
- FIGS. 8A to 8C is drawing depicting a braided implant in an implanted configuration and an expansion ring in a deployed configuration according to the present invention
- FIGS. 9A to 9B is a drawing depicting a braided implant in an implanted configuration and an expansion ring in a deployed configuration according to the present invention
- FIGS. 10A, and 10B are drawings depicting expansion rings in a collapsed configuration according to the present invention.
- FIGS. 11 and 12 are flow diagrams outlining method steps according to the present invention.
- Treating the aneurysm with the braided implant can have potential advantages over treatments utilizing embolic coils such as an ability to achieve higher packing density, ability to retract and reposition the implant during the implantation procedure, ability to perform implantation without ancillary devices such as stents or balloons, reduced risk of reanalyzing or compacting, and improved coverage across the aneurysm neck, for example.
- the delivery system can also serve to at least partially occlude the neck of the aneurysm.
- the present disclosure describes various example systems, devices, and methods that can be utilized for at least such purposes.
- the system for positioning and deployment of an intrasaccular device e.g. braided implant
- an intrasaccular device e.g. braided implant
- the outer pusher delivery tube
- a first (proximal) end of the braided implant can be mounted to a distal end of the outer pusher, while a second (distal) end of the braided implant can be attached to a distal end of the inner pusher.
- the first end of the braided implant can have a self-expanding ring mounted to the braid.
- the self-expanding ring can be made of Nitinol or other similar self-expanding material.
- the self-expanding ring can be crimped in place within a notch located at a distal end of the outer pusher to attach the braided implant to the outer pusher, and the first, proximal end of the braided implant can fit within a notch at the distal end of the inner pusher.
- the inner pusher can include a release mechanism of known design. For example, see U.S. Pat. Nos. 7,377,932 and 8,062,325, each incorporated herein, in their entirety, by reference.
- FIG. 1 depicts a cross-sectional view of an implantation device 100 having a braided implant 300 , a delivery tube 500 , and an inner elongated member 400 .
- the braided implant 300 can have an outer fold segment 302 near a distal end 314 of the braided implant 300 .
- the outer fold segment 302 can be attached to an expansion ring 200 , and the expansion ring 200 can be positioned within a notch 510 on an outer surface 508 of the delivery tube 500 near a distal end 514 of the delivery tube 500 .
- the braided implant can have a fold 303 positioned distal the distal end 514 of the delivery tube 500 such that the outer fold segment 302 extends proximally from the fold 303 over the delivery tube 500 and an inner fold segment 304 extends proximally from the fold 303 within the delivery tube 500 .
- the inner fold segment 304 can extend to a proximal end 312 of the braided implant 300 , and a distal end 414 of the inner elongated member 400 can be detachably attached to the proximal end 312 of the braided implant 300 .
- the delivery tube 500 and the inner elongated member 400 can each have proximal ends 512 , 412 that can be accessible by a user for manipulation of the device 100 during treatment.
- FIGS. 2A to 2C depict a braided implant 300 , an expansion ring 200 , and a delivery tube 500 that can be assembled to form at least part of an implantation device, such as the device 100 depicted in FIG. 1 .
- FIG. 2A depicts the braided implant 300 in a delivery configuration having an outer fold segment 302 separated from an inner fold segment 304 by a fold 303 .
- the inner fold 304 can be sized to fit within a lumen 504 of the delivery tube 504 such as the delivery tube 500 depicted in FIG. 2C .
- the inner fold 304 can extend to a first end 312 that can attach to an inner elongated member (not shown).
- the outer fold segment 302 can be positioned at a second end 314 of the braided implant and can be sized to fit over an expansion ring 200 , such as the expansion ring 200 depicted in FIG. 2B .
- the outer fold segment 302 can also be sized to fit over a distal end 514 of a delivery tube 500 such as the delivery tube depicted in FIG. 2C .
- FIG. 2B depicts the expansion ring 200 in a collapsed configuration.
- the expansion ring 200 can be sized to fit within a notch 510 on an outer surface 508 of a delivery tube 500 such as the delivery tube 500 depicted in FIG. 2C .
- the expansion ring 200 can include extending portions 210 that are attached by attaching segments 220 to form a ring having an opening 240 sized to fit within the delivery tube notch 510 .
- Each extending portion 210 can have a petal or oval shape such as shown in FIG. 2B , and the shape can be characterized by a first width 216 at a base of the extending portion 210 and a second width 218 near a middle of the extending portion that is wider than the first width 216 .
- FIG. 2C depicts a portion of a delivery tube 500 near a distal end 514 of the delivery tube 500 .
- the delivery tube 500 can have notch 510 near its distal end 514 on its outer surface 508 , and the delivery tube 500 can have a lumen 504 therethrough.
- FIG. 3 depicts a braided implant 300 , expansion ring 200 , and delivery tube 500 such as those depicted in FIGS. 2A to 2C assembled together to form an implantation device.
- an outer fold segment 302 of the braided implant 300 can be folded over and attached to an expansion ring 200 , and the expansion ring 200 can be sized to fit within a notch 510 on an outer surface 508 of the delivery tube 500 .
- An inner fold segment 304 of the braided implant 300 can extend into a lumen 504 of the delivery tube. Configured thusly, the depicted device can be inserted into a microcatheter for delivery to a treatment site.
- FIG. 4 depicts a cross-sectional view of an implantation system including a device 100 positioned within a microcatheter 600 for delivery to a treatment site.
- the microcatheter can be any catheter suitable for insertion into a patient and navigation to a treatment site. Once in place, the implantation device 100 can be fed through the catheter 600 to the treatment site.
- the catheter 600 can have a distal end 614 that can be positioned at a treatment site and a proximal end 612 that can be accessible to a user during a treatment procedure.
- FIGS. 5A to 5G are cross-sectional drawings illustrating a method of use of an implantation system for treatment of an aneurysm.
- FIG. 5A depicts an implantation system configured to begin implantation of the braided implant. As shown, the device can be approximately aligned with a distal end 614 of the microcatheter 600 .
- the braided implant 300 can be attached to an expansion ring 200 within a delivery tube notch 510 and can extend within the delivery tube 500 to attach to an inner elongated member 400 at a braid release 400 .
- FIG. 5B depicts a partially implanted braided implant 300 .
- the inner elongated member 400 can be pushed distally, pushing the braided implant 300 out of the delivery tube 500 and microcatheter 600 .
- the implant 300 can invert and begin to form an occlusive sack 308 .
- the inner elongated member 400 can be continued to be pushed distally, pushing more of the braided implant 300 out of the delivery tube 500 .
- the implant 300 can continue to invert and the occlusive sack 308 can expand.
- the inner elongated member 400 can be pushed until the braided implant 300 fully exits the delivery tube.
- the occlusive sack 308 can be fully expanded, and the portion of the braided implant 300 that does not invert to form the occlusive sack 308 can be pushed into the occlusive sack 308 forming an embolic filler braid 310 .
- the embolic filler braid 310 can remain attached to the inner elongated member 400 by a braid release mechanism 404 . While the embolic filler braid 310 is attached to the inner elongated member 400 , the braided implant 300 can be partially or fully retracted by pulling the inner elongated member 400 proximally. Once retracted, the implantation system can be repositioned and the inner elongated member 400 can be pushed distally to re-implant the braided implant 300 .
- the braided implant 300 can be released from the inner elongated member 400 by detaching the braid release mechanism 404 .
- the delivery tube 500 can be pushed distally from the microcatheter 600 , or the microcatheter 600 can be pulled proximally, and the expansion ring 200 can begin to expand from a delivery configuration as shown in FIGS. 5A to 5E to an expanded configuration. As the expansion ring 200 expands, it can begin to disengage the notch 510 in the delivery tube 500 .
- the expansion ring 200 can be made of a memory shape material that has a deformed shape in the delivery configuration that is crimped to fit within the notch 510 in the delivery tube and a predetermined shape that the expansion ring 200 expands to in the expanded or deployed configuration.
- the expansion ring 200 can make contact with bodily fluids, and the temperature of the bodily fluids can cause the expansion ring 200 to expand to the predetermined shape.
- the expansion ring 200 can continue to expand and disengage from the notch 510 in the delivery tube 500 . Once the expansion ring 200 is fully expanded in the deployed configuration, the delivery tube can be extracted.
- FIG. 6 depicts a braided implant in an implanted configuration with an expansion ring in a deployed configuration.
- the delivery tube 500 and microcatheter 600 can be extracted from the patent.
- FIG. 7A depicts a cut-away of an aneurysm 10 with a partially implanted braided implant 300 .
- a delivery catheter 600 can be delivered through a blood vessel 20 to a neck 16 of the aneurysm, and the braided implant 300 can be pushed through the neck 16 into the aneurysm 10 to form an occlusive sack 308 that extends to walls of the aneurysm 10 .
- the partially implanted braided implant 300 can be retracted and repositioned.
- FIG. 7B depicts a cut-away of an aneurysm 10 with a completely implanted braided implant 300 .
- An occlusive sack 308 extends the walls 14 of the aneurysm 10 , and an embolic braid 310 can fill the occlusive sack 308 . Together, the occlusive sack 308 and embolic braid 310 can fill the aneurysm sac 12 .
- the expansion ring 200 can reside near the aneurysm neck 16 and can have extending portions 210 that extend to appose the occlusive sack 308 .
- the expansion ring 200 can have attaching segments 220 that connect the extending portions 210 , and the attaching segments 220 can form a ring or other shape that defines an opening 240 of the expansion ring 200 and occlusive sack 308 .
- FIGS. 8A to 8C depict a braided implant 300 in an implanted configuration and an expansion ring 200 in a deployed configuration.
- the expansion ring 200 can have leaf or petal shaped extending portions 210 connected by attaching segments 220 .
- the expansion ring 200 can have a collapsed configuration as shown in FIG. 2B and expand to a deployed configuration as shown in FIGS. 8A to 8C .
- FIG. 8A depicts a side view of an occlusive sack 308 having an embolic filler braid 310 and the expansion ring 200 .
- FIGS. 8B and 8C illustrate a cross-sectional view of the occlusive sack 308 as indicated in FIG. 8A . Referring to FIG.
- the expansion ring can be constructed with multiple independent sections that are connected together with segment connectors 232 .
- each extending portion 210 can have a connector 232 positioned to connect two halves of each extending portion 210 .
- the occlusive sack 308 can be connected to the expansion ring at the attaching segments 220 , and the extending portions can be free to slide against the occlusive sack 308 as the expansion ring 200 opens to the deployed configuration. As illustrated in FIG.
- the attaching segments 220 can define a first circumference 324 of the occlusive sack 308 near an opening in the occlusive sack 308 , and the extending portions 210 can open the occlusive sack to a larger, second circumference 326 .
- FIGS. 9A and 9B depict a braided implant 300 in an implanted configuration and an expansion ring 300 in a deployed configuration.
- FIG. 9A is a side view
- FIG. 9B is a cross-sectional view as indicated in FIG. 9A .
- the expansion ring 200 can have four segments 230 connected by connectors 232 to form four corners.
- FIGS. 10A and 10B depict an expansion ring 200 in a collapsed configuration.
- the expansion ring 200 can be shaped as shown in FIGS. 10A and 10B in the collapsed configuration and expand to a deployed configuration.
- FIG. 10A depicts the expansion ring 200 within a notch 510 of a delivery tube
- FIG. 10B depicts the expansion ring of FIG. 10A absent the delivery tube.
- the segments 230 can be substantially straight, and bends 234 or connectors (not shown) can join the segments 230 to form a zig zag structure.
- the expansion ring can include attachment tabs 236 for attaching to a braided implant 300 .
- an expansion ring can have any number of segments, bends, and connectors to form a zig-zag shape.
- the zig-zag shape can have a tubular shape, having a substantially uniform circumference along its length.
- the expansion ring can have a tubular shape having a substantially uniform circumference larger than the collapsed circumference or a tapered shape having a first circumference near the occlusive sack opening and a second circumference at a region within an occlusive sack that is larger than the first circumference.
- Expansion rings disclosed herein are preferably formed of a shape memory material such as nickel-titanium alloy, or a shape memory polymer, for example, having a shape memory position in an expanded configuration.
- the expansion rings can be appropriately heat treated so that the expansion ring forms in the desired shape of the expanded shape memory position.
- Each expansion ring can be formed by cutting a tube or a sheet formed of a shape memory material such as nickel-titanium alloy, or shape memory polymer, by a laser
- FIGS. 11 and 12 are flow diagrams outlining example method steps for use of a device or system for treating an aneurysm.
- the method steps can be implemented by any of the example means described herein or by any means that would be known to one of ordinary skill in the art.
- a braided implantation delivery system having a braided implant, a delivery tube, and an expansion component can be provided.
- the braided implant can be attached to the expansion component.
- the expansion component can be engaged with a notch on the delivery tube.
- the braided implant can be implanted into the aneurysm.
- the expansion component can be expanded to disengage the expansion component from the notch.
- the expansion component can be released from the delivery tube, thereby releasing the braided implant from the delivery tube.
- a braided implantation delivery system having a braided implant, a delivery tube, an inner elongated member, and an expansion component can be provided.
- the braided implant can be attached to the expansion component.
- the braided implant can be attached to the inner elongated member.
- the expansion component can engage a notch on the delivery tube.
- the braided implant can be implanted into the aneurysm by pushing the inner elongated member distally, thereby pushing a portion of the braided implant into the aneurysm and forming an occlusive sack within the aneurysm, then detaching the braided implant from the inner elongated member.
- the expansion component can be expanded to disengage the expansion component from the notch.
- the expansion component can release the delivery tube, thereby releasing the braided implant from the delivery tube.
- the expansion component can expand to occlude at least a portion of the neck of the aneurysm and extend the occlusive sack across the neck of the aneurysm.
- the invention contemplates many variations and modifications of a system, device, or method that can be used to treat an aneurysm with a braided implant. Variations can include but are not limited to alternative geometries of elements and components described herein, utilizing any of numerous materials for each component or element (e.g.
- radiopaque materials including radiopaque materials, memory shape metals, etc.
- additional components including components to position the braided implant at a treatment site, extract the braided implant, or eject a portion of the braided implant from the interior of the delivery tube, utilizing additional components to perform functions described herein, or utilizing additional components to perform functions not described herein, for example.
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Abstract
Implant deployment systems can generally include a braided implant that can be detachably attached to a delivery tube by an expansion ring that can be positioned within a notch on an outer surface of the delivery tube near a distal end of the delivery tube. The implant can be positioned within a lumen of the delivery tube and remain attached to the delivery tube as the assembly is fed through a microcatheter to a treatment site. Once the braided implant is implanted, the expansion ring can move from a collapsed configuration that is engaged with the notch of the delivery tube to a deployed configuration that releases the delivery tube, thereby releasing the braided implant from the delivery tube.
Description
-
CROSS REFERENCE TO RELATED APPLICATION
-
The present application is a divisional application of U.S. patent application Ser. No. 16/140,836 filed Sep. 25, 2018, the entire contents of which are hereby incorporated by reference.
FIELD OF INVENTION
-
The present invention generally relates to medical instruments, and more particularly, delivery systems for a device for aneurysm therapy.
BACKGROUND
-
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 occlusion devices that either fill the sac of the aneurysm with embolic material or treating 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 occlusion devices typically utilize multiple embolic coils to either fill the sac or treat the entrance. In either treatment, obtaining an embolic coil packing density sufficient to either occlude the aneurysm neck or fill the aneurysm sac is difficult and time consuming. Further, aneurysm morphology (e.g. wide neck, bifurcation, etc.) can required ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density.
-
Naturally formed thrombotic masses formed by treating the entrance of the aneurysm with embolic coils can improve healing compared to aneurysm masses packed with embolic coils by reducing possible distention from arterial walls and permitting 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; at the same time, if the entrance is insufficiently packed, blood flow can persist into the aneurysm. Properly implanting embolic coils is therefore challenging, and 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 reanalyze or compact because of poor coiling, lack of coverage across the aneurysm neck, because of flow, or even aneurysm size.
-
An example alternative occlusion device is described in U.S. Pat. No. 8,998,947. However, this approach relies upon the use of embolic coils or mimics the coil approach and therefore suffers many of the limitations of embolic coil approaches such as difficulty achieving a safe packing density and inability to reposition once implanted.
-
It is therefore desirable to have a device which easily, accurately, and safely occludes a neck of an aneurysm or other arterio-venous malformation in a parent vessel without blocking flow into perforator vessels communicating with the parent vessel.
SUMMARY
-
Disclosed herein are various exemplary devices and systems of the present invention that can address the above needs. The devices generally can include a braided implant that can be detachably attached to a delivery tube by an expansion ring that can be positioned within a notch on an outer surface of the delivery tube near a distal end of the delivery tube. The implant can be positioned within a lumen of the delivery tube and remain attached to the delivery tube as the delivery tube and implant device assembly is fed through a microcatheter to a treatment site. Once at the treatment site, the braided implant can be implanted by pushing an inner elongated member, or pusher distally, thereby pushing the braided implant out of the distal end of the delivery tube. The inner elongated member can be detachably attached to an end of the braided implant such that the braided implant can be retracted and repositioned until properly positioned, then released. Once the braided implant is implanted, the expansion ring can move from a collapsed configuration that is engaged with the notch of the delivery tube to a deployed configuration that releases the delivery tube. Once released, the delivery tube can be extracted from the patient, leaving behind the implanted braided implant.
-
An example system for releasing an implant can include a braided implant, a delivery tube, an inner elongated member, and an expansion ring. The braided implant can have a first end detachably attached to a distal end of the inner elongated member and a second end mechanically connected to the expansion ring. The delivery tube can have a distal end with a notch positioned on an outer surface near the distal end of the delivery tube. The expansion ring can be movable from a collapsed configuration that is engaged with the notch to a deployed configuration that is disengaged from the notch and released from the delivery tube.
-
The braided implant can include a fold positioned distal the distal end of the delivery tube, an outer fold segment extending proximally from the fold, and an inner fold segment extending proximally from the fold such that the outer fold segment encompasses the inner fold segment. The outer fold segment can include the second end of the braided implant attached to the expansion ring, and the inner fold segment can include the first end attached to the inner elongated member.
-
The delivery tube can have a lumen therethrough and the inner fold segment of the braided implant can be positioned within the lumen.
-
The expansion ring can be mechanically connected to a portion of the outer fold segment such that the outer fold segment covers at least a portion of the notch and at least a portion of the expansion ring.
-
In the deployed configuration, the expansion ring can include an attached segment and an extending portion. The attached segment can be attached to the braided implant and can open a first region of the occlusive sack to a first circumference, and the extending portion can be attached to the attaching segment and can open a second region of the occlusive sack to a second circumference greater than the first circumference.
-
The expansion ring can have leaf shaped elements that extend radially as the expansion ring moves from the collapsed configuration to the deployed configuration.
-
The expansion ring can have segments joined to form a substantially tubular zig-zag structure when in the collapsed configuration.
-
The inner elongated member can be pushed distally to implant at least a portion of the braided implant.
-
An example device for treating an aneurysm can include a tubular delivery member, an inner elongated member, a braided tubular implant, and an expansion component. The braided tubular implant can be movable from a delivery configuration to an implanted configuration. In the delivery configuration, the braided tubular implant can have a first end extending proximally within an interior of the tubular delivery member that is detachably attached to a distal end of the inner elongated member and a second end extending distally from the distal end of the tubular delivery member and folding proximally over at least a portion of a notch positioned on an exterior of the tubular delivery member near a distal end of the tubular delivery member. The expansion component can be positioned within the notch on the tubular delivery member and attached to the braided tubular implant near the second end of the braided tubular implant. The expansion component can be movable from a collapsed configuration engaging the notch to a deployed configuration disengaging the notch.
-
The notch on the exterior of the tubular delivery member can be a circumferential indentation. The expansion component can be positioned in the circumferential indentation when in the collapsed configuration.
-
When in the implanted configuration, the braided tubular implant can have an occlusive sack and the expansion component can be positioned within the occlusive sack. The expansion component can have extending members that appose the occlusive sack when the expansion component is in the deployed configuration. When in the collapsed configuration, the expansion component can have an opening through which the braided tubular implant passes through upon movement from the delivery configuration to the implanted configuration.
-
An example method for treating an aneurysm can include the steps of providing a braided implantation delivery system having a braided implant, a delivery tube, and an expansion component, attaching the braided implant to the expansion component, engaging the expansion component with a notch on the delivery tube, implanting the braided implant in the aneurysm, expanding the expansion component to disengage the expansion component from the notch, and releasing the expansion component from the delivery tube which releases the braided implant from the delivery tube.
-
The method can further include the step of expanding the expansion component to occlude at least a portion of the neck of the aneurysm.
-
The step of implanting the braided implant in the aneurysm can include the step of forming an occlusive sack, and the step of expanding the expansion component can include the step of extending the occlusive sack across the neck of the aneurysm.
-
The provided braided implantation delivery system can further include an inner elongated member, and the method can further include the step of attaching the braided implant to the inner elongated member. The step of implanting the braided implant can further include the steps of pushing the inner elongated member distally, thereby pushing a portion of the braided implant into the aneurysm and detaching the braided implant from the inner elongated member.
BRIEF DESCRIPTION OF THE DRAWINGS
-
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.
- FIG. 1
is a cross-sectional drawing of an implantation device or system according to the present invention;
- FIG. 2A
is a drawing depicting braided implant in a delivery configuration according to the present invention;
- FIG. 2B
is a drawing depicting an expansion ring in a collapsed configuration according to the present invention;
- FIG. 2C
is a drawing depicting a distal end of a delivery tube according to the present invention;
- FIG. 3
is a drawing depicting a distal end of an implantation system according to the present invention;
- FIG. 4
is a cross-sectional drawing of an implantation system within a microcatheter according to the present invention;
- FIGS. 5A to 5G
are drawings illustrating a method of use of an implantation system according to the present invention;
- FIG. 6
is a drawing depicting a braided implant in an implanted configuration with an expansion ring in a deployed configuration according to the present invention;
- FIG. 7A
is a cut-away drawing of an aneurysm with a partially implanted braided implant.
- FIG. 7B
is a cut-away drawing of an aneurysm with a completely implanted braided implant.
- FIGS. 8A to 8C
is drawing depicting a braided implant in an implanted configuration and an expansion ring in a deployed configuration according to the present invention;
- FIGS. 9A to 9B
is a drawing depicting a braided implant in an implanted configuration and an expansion ring in a deployed configuration according to the present invention;
- FIGS. 10A, and 10B
are drawings depicting expansion rings in a collapsed configuration according to the present invention; and
- FIGS. 11 and 12
are flow diagrams outlining method steps according to the present invention.
DETAILED DESCRIPTION
-
Previous approaches utilizing embolic coils can be improved upon by treating the aneurysm entrance and/or packing the aneurysm with an embolic braided implant. For example, see U.S. patent application Ser. No. 15/903,860, which has been Published as US 2018/0242979 A1 on Aug. 30, 2018 and patented as U.S. Pat. No. 10,751,066 B2 on Aug. 25, 2020, incorporated herein, in its entirety, by reference. Treating the aneurysm with the braided implant can have potential advantages over treatments utilizing embolic coils such as an ability to achieve higher packing density, ability to retract and reposition the implant during the implantation procedure, ability to perform implantation without ancillary devices such as stents or balloons, reduced risk of reanalyzing or compacting, and improved coverage across the aneurysm neck, for example.
-
In braided implant delivery systems, it can be advantageous to maintain an attachment between an implant and a delivery device until the implant is in place at the treatment site, then detach the implant so that portions of the delivery device and system can be extracted. When implanted in an aneurysm, for example, the delivery system can also serve to at least partially occlude the neck of the aneurysm. The present disclosure describes various example systems, devices, and methods that can be utilized for at least such purposes.
-
The system for positioning and deployment of an intrasaccular device (e.g. braided implant) into an aneurysm can include an outer hollow braid pusher, an inner braid pusher, a braided implant, and a microcatheter. The outer pusher (delivery tube) be coaxially mounted over the inner pusher (inner elongated member). A first (proximal) end of the braided implant (braided intrasaccular component) can be mounted to a distal end of the outer pusher, while a second (distal) end of the braided implant can be attached to a distal end of the inner pusher. The first end of the braided implant can have a self-expanding ring mounted to the braid. The self-expanding ring can be made of Nitinol or other similar self-expanding material. The self-expanding ring can be crimped in place within a notch located at a distal end of the outer pusher to attach the braided implant to the outer pusher, and the first, proximal end of the braided implant can fit within a notch at the distal end of the inner pusher. The inner pusher can include a release mechanism of known design. For example, see U.S. Pat. Nos. 7,377,932 and 8,062,325, each incorporated herein, in their entirety, by reference.
- FIG. 1
depicts a cross-sectional view of an
implantation device100 having a
braided implant300, a
delivery tube500, and an inner
elongated member400. The
braided implant300 can have an
outer fold segment302 near a
distal end314 of the
braided implant300. The
outer fold segment302 can be attached to an
expansion ring200, and the
expansion ring200 can be positioned within a
notch510 on an
outer surface508 of the
delivery tube500 near a
distal end514 of the
delivery tube500. The braided implant can have a
fold303 positioned distal the
distal end514 of the
delivery tube500 such that the
outer fold segment302 extends proximally from the
fold303 over the
delivery tube500 and an
inner fold segment304 extends proximally from the
fold303 within the
delivery tube500. The
inner fold segment304 can extend to a
proximal end312 of the
braided implant300, and a
distal end414 of the inner
elongated member400 can be detachably attached to the
proximal end312 of the
braided implant300. The
delivery tube500 and the inner
elongated member400 can each have
proximal ends512,412 that can be accessible by a user for manipulation of the
device100 during treatment.
- FIGS. 2A to 2C
depict a
braided implant300, an
expansion ring200, and a
delivery tube500 that can be assembled to form at least part of an implantation device, such as the
device100 depicted in
FIG. 1.
FIG. 2Adepicts the
braided implant300 in a delivery configuration having an
outer fold segment302 separated from an
inner fold segment304 by a
fold303. The
inner fold304 can be sized to fit within a
lumen504 of the
delivery tube504 such as the
delivery tube500 depicted in
FIG. 2C. The
inner fold304 can extend to a
first end312 that can attach to an inner elongated member (not shown). The
outer fold segment302 can be positioned at a
second end314 of the braided implant and can be sized to fit over an
expansion ring200, such as the
expansion ring200 depicted in
FIG. 2B. The
outer fold segment302 can also be sized to fit over a
distal end514 of a
delivery tube500 such as the delivery tube depicted in
FIG. 2C.
- FIG. 2B
depicts the
expansion ring200 in a collapsed configuration. In the collapsed configuration, the
expansion ring200 can be sized to fit within a
notch510 on an
outer surface508 of a
delivery tube500 such as the
delivery tube500 depicted in
FIG. 2C. The
expansion ring200 can include extending
portions210 that are attached by attaching
segments220 to form a ring having an
opening240 sized to fit within the
delivery tube notch510. Each extending
portion210 can have a petal or oval shape such as shown in
FIG. 2B, and the shape can be characterized by a
first width216 at a base of the extending
portion210 and a
second width218 near a middle of the extending portion that is wider than the
first width216.
- FIG. 2C
depicts a portion of a
delivery tube500 near a
distal end514 of the
delivery tube500. As discussed in reference to
FIGS. 2A and 2B, the
delivery tube500 can have
notch510 near its
distal end514 on its
outer surface508, and the
delivery tube500 can have a
lumen504 therethrough.
- FIG. 3
depicts a
braided implant300,
expansion ring200, and
delivery tube500 such as those depicted in
FIGS. 2A to 2Cassembled together to form an implantation device. As shown, an
outer fold segment302 of the
braided implant300 can be folded over and attached to an
expansion ring200, and the
expansion ring200 can be sized to fit within a
notch510 on an
outer surface508 of the
delivery tube500. An
inner fold segment304 of the
braided implant300 can extend into a
lumen504 of the delivery tube. Configured thusly, the depicted device can be inserted into a microcatheter for delivery to a treatment site.
- FIG. 4
depicts a cross-sectional view of an implantation system including a
device100 positioned within a
microcatheter600 for delivery to a treatment site. The microcatheter can be any catheter suitable for insertion into a patient and navigation to a treatment site. Once in place, the
implantation device100 can be fed through the
catheter600 to the treatment site. The
catheter600 can have a
distal end614 that can be positioned at a treatment site and a proximal end 612 that can be accessible to a user during a treatment procedure.
- FIGS. 5A to 5G
are cross-sectional drawings illustrating a method of use of an implantation system for treatment of an aneurysm.
FIG. 5Adepicts an implantation system configured to begin implantation of the braided implant. As shown, the device can be approximately aligned with a
distal end614 of the
microcatheter600. The
braided implant300 can be attached to an
expansion ring200 within a
delivery tube notch510 and can extend within the
delivery tube500 to attach to an inner
elongated member400 at a
braid release400.
- FIG. 5B
depicts a partially implanted braided
implant300. As shown, the inner
elongated member400 can be pushed distally, pushing the
braided implant300 out of the
delivery tube500 and
microcatheter600. As the
braided implant300 exits the
delivery tube500, the
implant300 can invert and begin to form an
occlusive sack308.
-
As shown in
FIG. 5C, the inner
elongated member400 can be continued to be pushed distally, pushing more of the
braided implant300 out of the
delivery tube500. As the
braided implant300 further exits the
delivery tube500, the
implant300 can continue to invert and the
occlusive sack308 can expand.
-
As shown in
FIG. 5D, the inner
elongated member400 can be pushed until the
braided implant300 fully exits the delivery tube. As shown, the
occlusive sack308 can be fully expanded, and the portion of the
braided implant300 that does not invert to form the
occlusive sack308 can be pushed into the
occlusive sack308 forming an
embolic filler braid310. As shown, the
embolic filler braid310 can remain attached to the inner
elongated member400 by a
braid release mechanism404. While the
embolic filler braid310 is attached to the inner
elongated member400, the
braided implant300 can be partially or fully retracted by pulling the inner
elongated member400 proximally. Once retracted, the implantation system can be repositioned and the inner
elongated member400 can be pushed distally to re-implant the
braided implant300.
-
As shown in
FIG. 5E, the
braided implant300 can be released from the inner
elongated member400 by detaching the
braid release mechanism404.
-
As shown in
FIG. 5F, the
delivery tube500 can be pushed distally from the
microcatheter600, or the
microcatheter600 can be pulled proximally, and the
expansion ring200 can begin to expand from a delivery configuration as shown in
FIGS. 5A to 5Eto an expanded configuration. As the
expansion ring200 expands, it can begin to disengage the
notch510 in the
delivery tube500. The
expansion ring200 can be made of a memory shape material that has a deformed shape in the delivery configuration that is crimped to fit within the
notch510 in the delivery tube and a predetermined shape that the
expansion ring200 expands to in the expanded or deployed configuration. When the
delivery tube500 exits the
microcatheter600, the
expansion ring200 can make contact with bodily fluids, and the temperature of the bodily fluids can cause the
expansion ring200 to expand to the predetermined shape.
-
As shown in
FIG. 5G, the
expansion ring200 can continue to expand and disengage from the
notch510 in the
delivery tube500. Once the
expansion ring200 is fully expanded in the deployed configuration, the delivery tube can be extracted.
- FIG. 6
depicts a braided implant in an implanted configuration with an expansion ring in a deployed configuration. The
delivery tube500 and
microcatheter600 can be extracted from the patent.
- FIG. 7A
depicts a cut-away of an aneurysm 10 with a partially implanted braided
implant300. A
delivery catheter600 can be delivered through a
blood vessel20 to a
neck16 of the aneurysm, and the
braided implant300 can be pushed through the
neck16 into the aneurysm 10 to form an
occlusive sack308 that extends to walls of the aneurysm 10. The partially implanted
braided implant300 can be retracted and repositioned.
- FIG. 7B
depicts a cut-away of an aneurysm 10 with a completely implanted braided
implant300. An
occlusive sack308 extends the
walls14 of the aneurysm 10, and an
embolic braid310 can fill the
occlusive sack308. Together, the
occlusive sack308 and
embolic braid310 can fill the
aneurysm sac12. The
expansion ring200 can reside near the
aneurysm neck16 and can have extending
portions210 that extend to appose the
occlusive sack308. The
expansion ring200 can have attaching
segments220 that connect the extending
portions210, and the attaching
segments220 can form a ring or other shape that defines an
opening240 of the
expansion ring200 and
occlusive sack308.
- FIGS. 8A to 8C
depict a
braided implant300 in an implanted configuration and an
expansion ring200 in a deployed configuration. As shown in
FIGS. 8A to 8C, the
expansion ring200 can have leaf or petal shaped extending
portions210 connected by attaching
segments220. The
expansion ring200 can have a collapsed configuration as shown in
FIG. 2Band expand to a deployed configuration as shown in
FIGS. 8A to 8C.
FIG. 8Adepicts a side view of an
occlusive sack308 having an
embolic filler braid310 and the
expansion ring200.
FIGS. 8B and 8Cillustrate a cross-sectional view of the
occlusive sack308 as indicated in
FIG. 8A. Referring to
FIG. 8B, the expansion ring can be constructed with multiple independent sections that are connected together with
segment connectors232. As shown, each extending
portion210 can have a
connector232 positioned to connect two halves of each extending
portion210. The
occlusive sack308 can be connected to the expansion ring at the attaching
segments220, and the extending portions can be free to slide against the
occlusive sack308 as the
expansion ring200 opens to the deployed configuration. As illustrated in
FIG. 8C, the attaching
segments220 can define a
first circumference324 of the
occlusive sack308 near an opening in the
occlusive sack308, and the extending
portions210 can open the occlusive sack to a larger,
second circumference326.
- FIGS. 9A and 9B
depict a
braided implant300 in an implanted configuration and an
expansion ring300 in a deployed configuration.
FIG. 9Ais a side view, and
FIG. 9Bis a cross-sectional view as indicated in
FIG. 9A. As shown in
FIGS. 9A and 9B, the
expansion ring200 can have four
segments230 connected by
connectors232 to form four corners.
- FIGS. 10A and 10B
depict an
expansion ring200 in a collapsed configuration. The
expansion ring200 can be shaped as shown in
FIGS. 10A and 10Bin the collapsed configuration and expand to a deployed configuration.
FIG. 10Adepicts the
expansion ring200 within a
notch510 of a delivery tube, and
FIG. 10Bdepicts the expansion ring of
FIG. 10Aabsent the delivery tube. As shown, the
segments230 can be substantially straight, and bends 234 or connectors (not shown) can join the
segments230 to form a zig zag structure. The expansion ring can include
attachment tabs236 for attaching to a
braided implant300.
-
As will be appreciated and understood, an expansion ring can have any number of segments, bends, and connectors to form a zig-zag shape. In a collapsed configuration, the zig-zag shape can have a tubular shape, having a substantially uniform circumference along its length. In an expanded or deployed configuration, the expansion ring can have a tubular shape having a substantially uniform circumference larger than the collapsed circumference or a tapered shape having a first circumference near the occlusive sack opening and a second circumference at a region within an occlusive sack that is larger than the first circumference.
-
Expansion rings disclosed herein are preferably formed of a shape memory material such as nickel-titanium alloy, or a shape memory polymer, for example, having a shape memory position in an expanded configuration. The expansion rings can be appropriately heat treated so that the expansion ring forms in the desired shape of the expanded shape memory position. Each expansion ring can be formed by cutting a tube or a sheet formed of a shape memory material such as nickel-titanium alloy, or shape memory polymer, by a laser
- FIGS. 11 and 12
are flow diagrams outlining example method steps for use of a device or system for treating an aneurysm. The method steps can be implemented by any of the example means described herein or by any means that would be known to one of ordinary skill in the art.
-
Referring to
method700 outlined in
FIG. 11, in
step710, a braided implantation delivery system having a braided implant, a delivery tube, and an expansion component can be provided. In
step720, the braided implant can be attached to the expansion component. In
step730, the expansion component can be engaged with a notch on the delivery tube. In
step740, the braided implant can be implanted into the aneurysm. In
step750, the expansion component can be expanded to disengage the expansion component from the notch. In
step760, the expansion component can be released from the delivery tube, thereby releasing the braided implant from the delivery tube.
-
Referring to
method800 outlined in
FIG. 12, in
step810, a braided implantation delivery system having a braided implant, a delivery tube, an inner elongated member, and an expansion component can be provided. In
step820, the braided implant can be attached to the expansion component. In
step825, the braided implant can be attached to the inner elongated member. In
step830, the expansion component can engage a notch on the delivery tube. In
step840, the braided implant can be implanted into the aneurysm by pushing the inner elongated member distally, thereby pushing a portion of the braided implant into the aneurysm and forming an occlusive sack within the aneurysm, then detaching the braided implant from the inner elongated member. In
step850, the expansion component can be expanded to disengage the expansion component from the notch. In
step860, the expansion component can release the delivery tube, thereby releasing the braided implant from the delivery tube. In
step870, the expansion component can expand to occlude at least a portion of the neck of the aneurysm and extend the occlusive sack across the neck of the aneurysm.
-
The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of a system, device, or method that can be used to treat an aneurysm with a braided implant. Variations can include but are not limited to alternative geometries of elements and components described herein, utilizing any of numerous materials for each component or element (e.g. radiopaque materials, memory shape metals, etc.), utilizing additional components including components to position the braided implant at a treatment site, extract the braided implant, or eject a portion of the braided implant from the interior of the delivery tube, utilizing additional components to perform functions described herein, or utilizing additional components to perform functions not described herein, for example. These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.
Claims (20)
1. A method for treating an aneurysm, the method comprising:
providing a braided implantation delivery system, wherein the braided implantation delivery system comprises a braided implant, a delivery tube comprising a notch, and an expansion component;
attaching the braided implant to the expansion component;
engaging the expansion component with the notch;
implanting the braided implant in the aneurysm;
expanding the expansion component to disengage the expansion component from the notch; and
releasing the expansion component from the delivery tube which releases the braided implant from the delivery tube.
2. The method of
claim 1further comprising the step of expanding the expansion component to occlude at least a portion of the neck of the aneurysm.
3. The method of
claim 1, wherein the step of implanting the braided implant in the aneurysm comprises the step of forming an occlusive sack, and
wherein the step of expanding the expansion component comprises the step of extending the occlusive sack across the neck of the aneurysm.
4. The method of
claim 1, wherein the expansion component is in a collapsed configuration when engaged with the notch and in a deployed configuration when released from the notch.
5. The method of
claim 1, wherein the braided implantation delivery system further comprises an inner elongated member, the method further comprising the step of attaching the braided implant to the inner elongated member.
6. The method of
claim 5, wherein the step of implanting the braided implant in the aneurysm further comprises the steps of:
pushing the inner elongated member distally, thereby pushing a portion of the braided implant into the aneurysm; and
detaching the braided implant from the inner elongated member.
7. The method of
claim 6further comprising retracting and repositioning the braided implant within the aneurysm by one or both of pushing and pulling the inner elongated member.
8. The method of
claim 6further comprising pushing the inner elongated member distally such that the braided implant inverts to form an occlusive sack.
9. The method of
claim 6, wherein a portion of the braided implant does not invert to form the occlusive sack and is pushed into the occlusive sack to form an embolic filler braid.
10. The method of
claim 9, wherein the embolic filler braid is detachably attached to the inner elongated member.
11. The method of
claim 10further comprising partially or fully retracting the braided implant from the aneurysm by pulling the inner elongated member proximally, thereby allowing repositioning of the braided implant.
12. The method of
claim 10further comprising pushing the inner elongated member distally to re-implant the braided implant.
13. The method of
claim 1wherein the braided implant comprises:
a fold positioned distal the distal end of the delivery tube;
an outer fold segment extending proximally from the fold and comprising the second end of the braided implant; and
an inner fold segment encompassed by the outer fold segment, extending proximally from the fold, and comprising the first end of the braided implant.
14. The method of
claim 13, wherein the expansion component is mechanically connected to a portion of the outer fold segment, the outer fold segment covering at least a portion of the notch and at least a portion of the expansion ring.
15. The method of
claim 4, wherein the deployed configuration of the expansion component comprises:
an attaching segment attached to the braided implant and opening a first region of the occlusive sack to a first circumference; and
an extending portion attached to the attaching segment and opening a second region of the occlusive sack to a second circumference greater than the first circumference.
16. The method of
claim 4, wherein the expansion component comprises a plurality of leaf shaped elements that extend radially as the expansion component moves from the collapsed configuration to the deployed configuration.
17. The method of
claim 4, wherein the expansion component in the collapsed configuration comprises a plurality of segments joined to form a substantially tubular zig-zag structure.
18. The method of
claim 13, wherein the delivery tube further comprises a lumen therethrough and the inner fold segment of the braided implant is positioned within the lumen.
19. The method of
claim 1, wherein the notch comprises a circumferential indentation on the exterior of the tubular delivery member.
20. The method of
claim 1, wherein the expansion component is positioned in the circumferential indentation when in a collapsed configuration.
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