Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12027—Type of occlusion
  • A61B17/12031—Type of occlusion complete occlusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/1214—Coils or wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12131—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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12131—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
  • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • 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
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
  • A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids

Definitions

• the present invention is directed to devices for occluding lumens within a body and, more particularly, directed to devices employing an expansile frame associated with an expansile plug and methods for use and manufacturing of such devices.
• a blood vessel lumen, duct, aneurysm, hole, fistula, or appendage, referred to herein collectively as a lumen
• a lumen a blood vessel, lumen, duct, aneurysm, hole, fistula, or appendage, referred to herein collectively as a lumen
• the optimum treatment for an aneurysm is to occlude the vessel that feeds blood into the lesion.
• this vessel may be the carotid artery, or in the peripheral vasculature, it may be an iliac artery.
• Additional examples include: a patent ductus arteriosus (PDA) which shunts blood from the aorta to the pulmonary artery in some newborn babies; a patent foramen ovale (PFO), an open flap in the septum separating the heart's atria; a blood vessel feeding a tumor; an atrial septal defect (ASD), a hole in the septum between the atria; an iliac artery in conjunction with a stent graft and a femoral-femoral bypass operation the closure of which provides treatment of an aortic aneurysm; an atrial appendage, which is a malformation that allows blood clots to collect, which, in turn, may cause a stroke.
• PDA patent ductus arteriosus
• fistula in which organs are improperly connected together
• APM arteriovenous malformation
• devices in the prior art that may be used to close or otherwise occlude these lumens.
• One such device is a detachable balloon which is inflated in the target lumen with a liquid or polymer, then detached and maintained at or in the target.
• Another device is a basket-like structure formed of wires that causes clots in the blood flow thereby blocking a blood vessel.
• Another device is a coil or hydrogel coated coil that is deployed in a lumen.
• Another device is a self-expanding patch that blocks a PFO or ASD from both sides.
• Further examples include plugs, beads, or particles made from hydrogel or polyvinyl alcohol (PVA) that may expand upon blood contact and serve to occlude or block a lumen.
• PVA polyvinyl alcohol
• One embodiment according to the present invention includes an occlusion device in which the support structure or frame expands circumferentially within the lumen to secure an expansile plug or embolic material. Once in place, the expansile plug or embolic material expands, thereby occluding the target lumen.
• Another embodiment according to the present invention includes a radially expandable support structure having a closed portion for capturing subsequently delivered embolic material, such as embolic coils.
• the structure may have a closed portion at its distal end or at its middle (forming an hourglass shape).
• the closed portion may be formed from the support structure itself or from a discrete, second layer that is attached within the support structure.
• the occlusion devices of the present invention can be useful in multiple medical fields such as radiology, gastroenterology, gynecology, cardiology, neurovascular intervention, and oncology.
• FIG. 1 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 2 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 3 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 4 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 5 is a plan view of a portion of a device according to one embodiment of the present invention.
• FIG. 6 is a side elevation view of a device according to one embodiment of the present invention.
• Fig. 7 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 8 is a side elevation view of a portion of a device according to one embodiment of the present invention.
• FIG. 9 is a side elevation view of a device according to one embodiment of the present invention.
• Fig. 10A is a side elevation view of a device according to one embodiment of the present invention
• Fig. 10B is a side elevation view of a device according to one embodiment of the present invention
• Fig. 1 1 is a side elevation view of a device according to one embodiment of the present invention.
• Fig. 12 is a side elevation view of the device seen in Fig. 1 1 ;
• Fig. 13 is a side elevation view of a device according to one embodiment of the present invention.
• Fig. 14 is a side elevation view of a device according to one embodiment of the present invention.
• the embodiments of the present invention are generally directed to lumen occlusion devices having an expandable framework.
• the framework may have an attached, expansile plug or may be filled with embolic material after deployment.
• Figs. 1 -5 illustrate a device 10 according to the present invention, which employs one or more expandable plug 12 associated with a frame or support structure 14.
• the frame 14 is preferably formed of a single wire 16 braided or woven into a generally tubular form but can also be formed by weaving multiple, discrete wires or laser cutting a tube.
• the frame 14 has an external diameter of approximately 4.5 millimeters and a length of approximately 15 millimeters.
• the wire 16 is preferably formed of NiTi or nickel-titanium alloy, also known as Nitinol, having a diameter of approximately 0.00325 inches.
• the frame 14 has a proximal end portion 18 and a distal end portion 20 that are outwardly flared.
• the proximal end portion 18 and the distal end portion 20 employ projecting elements 22 extending radially outward.
• the projecting elements 22 take the form of loops, hooks, protuberances, or staples, which tend to increase the friction between the frame and the lumen. These projecting elements 22 tend to hold the frame 14 in place in conjunction with the frame's 14 radial force. This feature is especially useful when the area or lumen to be obstructed is relatively short, which reduces the aggregate radial force of the frame 14 compared to a longer lumen, or where there is high flow such as an iliac or carotid artery.
• markers such as marker bands, coils, and plating, not shown, are connected to the frame 14.
• markers can be located at the ends of the projecting elements 22, near the plug 12, and/or along a length of the frame 14 to assist the operator with visualization, guidance and delivery of the device 10 during deployment.
• the relaxed or minimum energy state configuration of the frame 14 is formed by weaving, winding, or otherwise manipulating the wire 16 about a fixture.
• the frame 14 is subjected to a heat treatment.
• the frame 14 is maintained at a temperature of about 500 degrees Celsius to about 1000 degrees Celsius for approximately 30 to 90 minutes.
• the frame 14 is cooled to room temperature and ultrasonically cleaned.
• the resultant secondary configuration is thereby made permanent and becomes the relaxed or minimum energy state configuration of the device 10.
• the frame 14 is formed of a plurality of the same or a combination of different wires 18.
• the wire 16 may be formed of Nitinol, steel, chromium-cobalt alloy, and/or platinum, and/or of polymers such as Teflon, polyethylene terephthalate (PET), or polyether ether ketone (PEEK).
• polymers such as Teflon, polyethylene terephthalate (PET), or polyether ether ketone (PEEK).
• the frame 14 can be any of the stents seen in U.S. Application No. 13/003,277 filed January 7, 201 1 and U.S. Application No. 13/31 1 ,430 filed December 05, 201 1 , the contents of which are hereby incorporated by reference.
• the plug 12 is formed of, for example, hydrogel or other similar expansile material such as PVA or hydrogel foam. As shown in Figs. 1 -5, the plug 12 is preferably formed in the shape of a cylinder that expands after being introduced into a patient. In a reduced or non-expanded state, the plug 12 preferably has a diameter of approximately 1 millimeter and a length of approximately 7 millimeters. In an expanded, unrestricted state (for example, caused by exposure of the plug 12 to water or blood), the plug 12 preferably has a diameter of approximately 4 millimeters and a length of approximately 14 millimeters.
• the plug 12 can be constructed from a variety of known polymeric materials including, for example, biocompatible, macroporous or microporous, hydrophilic or hydrophobic hydrogel foam materials. Suitable materials are described in U.S. Patent No. 6,165,193 to Greene Jr. et al. and U.S. Patent No. 6,878,384 to Cruise et al., each of which is hereby incorporated by reference.
• the plug 12 may also comprise polymers such as polyvinyl alcohol foams as described in U.S. Patent No. 5,823,198 to Jones et al., which is also incorporated herein by reference.
• the plug 12 is made of a biocompatible, macroporous, hydrophilic hydrogel foam material, in particular a water- swellable foam matrix formed as a macroporous solid comprising a foam stabilizing agent and a polymer or copolymer of a free radical polymerizable hydrophilic olefin monomer cross-linked with up to about 10% by weight of a multiolefin-functional cross- linking agent.
• a suitable material of this type is described in U.S. Patent No. 5,750,585 to Park et al., the disclosure of which is incorporated herein by reference.
• Suitable material is a porous hydrated polyvinyl alcohol foam (PAF) gel prepared from a polyvinyl alcohol solution in a mixed solvent consisting of water and a water-miscible organic solvent, as described, for example, in U.S. Patent No. 4,663,358 to Hyon et al., the disclosure of which is incorporated herein by reference.
• Still another suitable material is PHEMA, as discussed in U.S. Patent No. 4,663,358 to Hyon et al., "Hydrolysed Microspheres from Cross-Linked Polymethyl Methacrylate", J. Neuroradiol., Vol. 18, pp. 61 -69 (1991 ), both of which are hereby incorporated by reference.
• the plug 12 may incorporate radiopaque elements, for example, iodine or tantalum powder, mixed into the material forming the plug 12 during manufacturing to help visualize the location of the plug 12 and the device 10 before and after deployment.
• radiopaque elements for example, iodine or tantalum powder
• the plug 12 is preferably associated with or otherwise attached to the frame 14 by a thread 24.
• the thread 24 is formed of, for example, polyethylene terephthalate (PET) having a diameter of approximately 0.0009 inches.
• PET polyethylene terephthalate
• One end of the thread 24 is skewered or otherwise passed through a portion of the plug 12 and around the wire 16 of the frame 14 and then fixed to a second end of the thread 24 so as to form a loop.
• a plurality of threads 24 may also be employed to secure the plug 12 to the frame 14 at the same or at different locations along a dimension of the frame 14.
• the plug 12 is associated with the frame 14 by employing a thread 24 formed of polypropylene or olefin elastomer such as Engage. Still in other embodiments, the plug 12 is associated with the frame 14 by mechanical methods such as: constructing the frame 14 in the shape of a cage or basket that holds the plug 12 within; directly skewering an element of the frame 14, such as a portion of the wire 16, through the plug 12; gluing the plug to the frame 14; incorporating mechanical grasping elements into the frame 14 to hold the plug 12; or using heat- shrinkable plastic to hold the plug 12 to the frame 14. [0040] After the frame 14 and plug 12 have been associated, the device 10 can be loaded into a delivery device such as a catheter or sheath.
• a delivery device such as a catheter or sheath.
• the device 10 can be compressed on an inner pusher member that is located within a retractable sheath.
• the delivery device has a size of about 4 French for delivery into a lumen or vessel between about 2-4 millimeters in diameter.
• Fig. 6 illustrates another embodiment of a device 100 having a generally "hourglass" shaped side-profile. More specifically, the device 100 includes a frame 102, preferably composed of a single wire that forms a spiral or a substantially planar helix. Loops of the frame 102 have a generally smaller diameter at a middle region of the frame 102 and increase in diameter towards the distal and proximal ends of the frame 102.
• One or more plugs 12 are attached at the narrow, center portion of the frame 102 as described in previous embodiments, for example by employing threads 24. Alternatively, one or more plugs 12 may be anchored to the frame 102 by skewering the plugs 12 with the frame 102. Radiopaque markers, not shown, may also be employed as previously described regarding the device 10.
• the device 100 is at least partially linearized (i.e., the coil shape is at least partially uncoiled into a generally linear shape) for delivery via a delivery catheter and deployed.
• the device 100 is especially useful for closing lumens that have large diameters relative to their lengths and lumens in which a treatment device is subjected to forces from multiple directions. Examples of these types of lumens are ASD, PFO, and PDA's.
• the device 100 is useful in occluding these lumens because the distal end of the frame 102 can be placed on one side of the lumen (i.e. in the atrium or pulmonary artery), the plug 12 positioned substantially within the lumen, and the proximal end on the other side of the lumen. Since the frame 102 tends to revert to its original substantially helical configuration, it tends to exert force on both sides of the septum or ductus, thus sandwiching the plug in the lumen.
• a device 40 employs a frame 44 that is generally similar to the previously described frame 14, except that a distal end portion 46 and a proximal end portion 48 of the frame 44 are closed such that an interior of the frame is at least partially closed-off. This configuration prevents the plug 12 from migrating in one or both directions in the event that the thread 24 holding the plug 12 in place breaks or if the hydrated plug 12 could not be anchored by the thread 24 alone.
• the device 42 employs a frame 44 as previously described, except that the upstream, proximal end 50 remains open and preferably at least partially flared.
• the plug 12 may, but need not be, attached to the frame by a thread 24. As the downstream or distal end 46 of the frame 44 is closed, the plug 12 is prevented from migrating downstream. In such a configuration, the plug 12 may be delivered into the frame as a separate step during deployment of the device.
• one or both ends of the frame are at least partially closed or covered with, for example, a mesh, crossing or interwoven threads, or fabric.
• This covering can be attached over either open or closed ends of the frame and prevents the plug 12 from migrating away from the frame and target.
• a device 60 includes a frame 62 comprising a twisted wire that forms a corkscrew shape.
• the twisted wire of the frame 62 can form uniform-sized loops so as to maintain a relatively uniform or linear shape.
• the loops of the frame 62 may also have varying sizes so as to form a triangular, conical, or hourglass shape.
• the plug 12 is attached to the frame 62 directly by skewering the wire or coil through one or more plugs 12 or by using the thread 24 or wire to tether the plug(s) 12 to the frame.
• the frame 62 is sized to have a diameter or height that will be approximately the same size or somewhat larger than the target lumen.
• the device 60 can be loaded into a delivery catheter by compressing it into a linear configuration (e.g., by physically decreasing the size of the loops) within a lumen of the catheter or onto a delivery pusher. As the device 60 is pushed or released into the target lumen, it expands to its relaxed, twisted configuration.
• Figs. 10A and 10B illustrate yet another embodiment of an occlusion device 1 10 that comprises a plug 12 through which a plurality of filaments or wires 1 14 pass through.
• the plug 12 is formed of, for example, hydrogel or other similar expansile material such as PVA or foam.
• the wires 1 14 are passed through the plug 12 along an approximate central axis 1 18 of the device 1 10.
• the wires 1 14 are configured (e.g., pre- shaped) to curve or bend away from each other in a radial direction relative to the central axis 1 18. In one example, the wires 1 14 bend or extend away from the approximate central axis 1 18 for a length of approximately 6 millimeters.
• the wires 1 14 can be radially oriented in a uniform spacing, such as approximately 120 degrees apart, or in any variety of symmetrical and asymmetrical, non-uniform spacing, such as 100, 130, 130 degrees.
• the wires 1 14 are composed of a shape memory material such as Nitinol, have a diameter of about 0.003 inches, and have ends that are capped with radiopaque markers 120.
• the wires 1 14 may be formed by laser cutting a hypotube to the desired dimensions of the wire 1 14.
• the device 1 10 is particularly useful for closing a PDA.
• the device 1 10 can be collapsed into a delivery system and delivered to a target site by conventional means.
• the plug 12 expands to a dimension of about 0.185 inches after deployment and closes off or otherwise seals the target site (e.g., a PDA).
• the expanded and radially curved wires 1 14 are preferably deployed on either side of the defect and thereby provide support for the plug 12 so as to prevent migration.
• the device 1 10 may include any number of wires 1 14, but preferably between at least 2 and 20 wires, and more preferably at least 3-6 wires.
• the device 1 10 is relatively simple to construct and tends to have a smaller delivery profile as compared with many other device shapes.
• an expandable plug 12 While the previously described embodiments have included the use of an expandable plug 12, it is also possible to use one or more of these devices without a plug 12. More specifically, a material can be added upstream or adjacent to the deployed device so as to cause the blockage. For example, one or more embolic coils (which may or may not include an expandable material such as hydrogel), can be delivered within the deployed and expanded device.
• a material can be added upstream or adjacent to the deployed device so as to cause the blockage.
• embolic coils which may or may not include an expandable material such as hydrogel
• Figs. 1 1 and 12 illustrate one such example of an intravascular self-expanding stent-type device 140 that can be filled with embolic materials such as embolic coils 168.
• embolic materials such as embolic coils 168.
• Other embolic material such as a liquid embolic material (e.g. Onyx), embolizing beads (e.g. Embosphere), or other embolizing agents can also be used.
• the device 140 comprises a frame or a support structure 142 that is circumferentially open on both a distal end 144 and a proximal end 146, as described above regarding frame 14.
• a cinched center section 148 creates an embolic material capture region that obstructs the central lumen of the device 140, thereby acting as a stable barrier for subsequent embolic material delivery.
• the center 148 can be woven together or fastened by a thread, wire, clip or other fastening member and allows for a decreased diameter and controlled deployment.
• a second delivery catheter 141 (or possibly the same delivery catheter) is advanced to the proximal end 146 of the device 142 and embolic material is deployed into the proximal half of the device 142.
• the embolic material is one or more embolic coils 168.
• These embolic coils 168 may include an expansile coating (such as hydrogel) that expands within a patient's blood or may include expansile material that is separate from the coils 168.
• half of the device 142 is filled with material, thereby occluding most of the blood flow through the lumen 152. Over time, this occlusion will likely become completely blocked by expansion of any expansile coating on the embolic coils 168, clotting of the blood and/or tissue growth over the embolic coils 168.
• Fig. 13 illustrates an intravascular self-expanding stent-type device 160 that is generally similar to the previously described device 42 of Fig. 8, but without the plug 12.
• the device 160 comprises a frame 162 that facilitates lumen occlusion when used in conjunction with an embolic coil 168 or other embolic materials. Only a downstream or distal end 164 of the frame 162 is at least partially closed and a proximal end 166 is open, as described above regarding the frame 14.
• the device 162 is delivered to a desired occlusion point in a lumen 152.
• the distal end of the delivery catheter 141 is positioned adjacent or even partially inside of the framework 162 and the embolic coils 168 are deployed within the device 160. Since the downstream or distal end 164 of the frame 162 is closed to act as a stable barrier, the embolic coil 168 is prevented from migrating downstream through the lumen 152, thus occluding the lumen 15 ⁇ other embolic materials, such as hydrogel, may be used in conjunction with device 160 and embolic coils 168.
• both ends of the device 162 may be closed and the embolic material, such as embolic coils 168 can be delivered inside a cavity of the device, through apertures in the weaving.
• embolic coil deliver catheter can be inserted through an aperture created by its woven wires and the embolic coil can be advance into the device 162.
• Fig. 14 illustrates a dual-layer stent device 170 that includes an outer, anchoring stent layer 172 and an inner, occluding stent layer 180.
• this dual- layer stent device 170 is similar to and can be constructed according to the teachings in U.S. Application No. 13/003,277 filed January 7, 201 1 and U.S. Application No. 13/31 1 ,430 filed December 05, 201 1 , the contents of which are incorporated herein by reference.
• the outer stent layer 172 expands against the lumen 152 to anchor the device 170 against the lumen 152 while the inner stent layer 180 is cinched near a middle location 178 to form an hourglass shape.
• the inner stent layer 180 can be cinched at its distal end to create a shape similar to that of device 160 in Figure 13.
• occluding material such as embolic coils 168 can be delivered into the proximal end 176 of the device 170 to occlude the lumen 152.
• the inner stent layer 180 may be coated in an expansile material, such as hydrogel, in addition to or in place of the discretely-added occluding material.
• the outer, anchoring stent layer 172 is preferably composed of one or more wires having a larger diameter than those composing the inner, occluding stent layer 180. Additionally, the outer layer 172 can be woven to have apertures that are larger than those of the inner stent layer 180, when both layers are in an expanded configuration. In this respect, the outer layer 172 can provide relatively more radially outward force for anchoring while the inner layer 180 can provide a relatively finer- woven occlusive barrier.
• the inner stent layer 180 is connected to the outer stent layer 172 at its proximal end and optionally at its distal end. Additionally, the inner stent can be located near the outer stent layer's proximal end 176, distal end 174, middle, or any positions therebetween.
• the device 170 has several advantages compared to prior art lumen obstruction devices that occlude a lumen by preventing dislodgement of embolization coils,
• the present invention allows partial deployment of re-sheathing due to its attachment mechanism, allowing for a more controlled placement of the device.
• the present invention can be used with much smaller catheters, conceivably down to 1 .7 French compared to a 5 French or greater sized catheter. This allows the present invention to navigate more tortuous and distal lumens, thereby being able to treat a wider range of patients. Additionally, this allows the same catheter to be used to deliver both the device and the embolic coils and materials. Further, the present invention minimizes any trauma imposed on the lumen wall by using a self-expanding radial force tuned for the artery size.
• the previously described device can be made with a variety of materials including, but not limited to bioactive, thrombogenic, hydrogel, or other therapeutic coatings. Further, these devices can be made in a variety of different sizes and lengths and can be cinched or enclosed at any location along the length of the stent. To improve clinical outcomes, the device can be coated with, for example, bioactive or hydrogel coatings. The device can be used with varying porosities to provide full or partial flow occlusion to limit the amount of embolic materials required to sufficiently occlude a lumen.
• the device can be delivered by pushing the device through a catheter or sheath with a specialized pusher or a guidewire by attaching one or both ends of the device to a delivery pusher that holds the device so that it can be positioned and repositioned within the lumen.
• the device is then selectively detached from the delivery system by, for example, mechanically, thermally, hydraulically, or electrolytically severing an attachment member associating the device and the delivery system.
• the device incorporates at least one radiopaque marker band positioned at one end of the device. The marker is configured to interlock to a mating element on a delivery pusher. The user can partially deploy and retrieve the device using the interlock to pull back on the device. Release of the device from the delivery system is, for example, accomplished by pushing most of the implant out of the delivery catheter and/or retracting the delivery catheter to expose the interlock release(s).
• a monofilament is wrapped through the proximal end of the device and then attached to a delivery pusher incorporating a heater that can be activated by electrical current.
• the user can fully or partially deploy the device and then reposition or recover the device if needed.
• the user activates the heater thereby causing the monofilament to break from and release the device.
• one end of the device incorporates an atraumatic tip while the other end is soldered to a delivery pusher.
• the user can deploy and reposition the device as needed, and then pass a current through the delivery pusher.
• the current causes the solder to corrode at an accelerated rate in the patient's blood and to release the end of the device that was soldered to the pusher.
• the end of the device incorporates a coupling element such as a tube of radiopaque material that is configured to allow a heat-severable thread having two ends to pass through the coupling.
• a coupling element such as a tube of radiopaque material that is configured to allow a heat-severable thread having two ends to pass through the coupling.
• One end of the thread is tied to the device and the other end of the thread is passed through a heater incorporated into the end of a delivery pusher.
• the device is detached by the user as previously described.
• the delivery system includes a sheath disposed over a pusher member.
• a stent device is compressed over a distal end of the pusher and the sheath is placed over the stent.
• the stent is maintained in place, in part, via frictional forces. Additional details of such a delivery system can be found in U.S. Application No. 13/003,277 filed January 7, 201 1 and U.S. Application No. 13/31 1 ,430 filed December 05, 201 1 , both of which were previously incorporated by reference in this specification.
• the present device and method has several advantages over the prior art. In comparison to prior art detachable balloons, the device of the present invention is easier to place, requires fewer steps to deploy, and has a lower tendency to migrate after placement if, for example, a balloon-based device starts to leak over time.

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• 2012
  • 2012-05-11 EP EP12781855.7A patent/EP2707077B1/en active Active
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