US2008215151A1PendingUtilityA1

Bone barrier device, system, and method

47
Assignee: KOHM ANDREWPriority: Mar 2, 2007Filed: Mar 2, 2007Published: Sep 4, 2008
Est. expiryMar 2, 2027(~0.6 yrs left)· nominal 20-yr term from priority
A61B 2017/00867A61B 90/39A61B 17/7098
47
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Claims

Abstract

A bone barrier device can comprise a barrier material that can be inserted into the interior of a bone and adapted to prohibit substantially all of a bone filler material from flowing through and/or around the barrier material into and through a compromised portion of the bone. Such a barrier device may be inserted into a void created in the interior of a vertebral body so as to prevent the flow of bone cement through and/or around the barrier material into a compromised endplate and/or vertebral body wall. The bone barrier device may comprise a barrier material having an open weave, mesh, and/or through hole design adapted to reduce the flow, and to allow some flow, of bone filler material through and/or around the barrier material.

Claims

exact text as granted — not AI-modified
1 . A device, comprising:
 a structure comprising a barrier material having an outer surface and an inner surface and implantable in a bone,   the structure collapsible to an undeployed configuration capable of percutaneous insertion to the interior of the bone and expandable to a deployed configuration in the interior of the bone,   wherein in the deployed configuration substantially all of a bone filler material injected adjacent the inner surface is prohibited from flowing to the outer surface.   
     
     
         2 . The device of  claim 1 , wherein the structure is adapted to be expandable to a deployed configuration with an expandable body for restoring height to a vertebral body. 
     
     
         3 . The device of  claim 1 , further comprising a sheath covering the device in the undeployed configuration, and wherein the structure is adapted to expand to a deployed configuration when the sheath is removed from the device. 
     
     
         4 . The device of  claim 1 , further comprising a plurality of the devices, each device adapted to restrict flow of the bone filler material into a separate portion of the bone. 
     
     
         5 . The device of  claim 1 , the structure being rigid, and further comprising a first bone contact portion and a second bone contact portion,
 wherein when the first bone contact portion contacts at least a first portion of the bone from the interior of the bone and the second bone contact portion contacts at least a second portion of the bone, a load on the first portion of the bone is transferred through the structure to the second portion of the bone.   
     
     
         6 . The device of  claim 5 , wherein the bone comprises a vertebral body, the first portion of the bone comprises an endplate, and the second portion of the bone comprises a side wall of the vertebral body. 
     
     
         7 . The device of  claim 5 , wherein the bone comprises a vertebral body, the first portion of the bone comprises a first endplate, and the second portion of the bone comprises a second endplate opposite the first endplate. 
     
     
         8 . The device of  claim 1 ,
 wherein the implantable structure further comprises six sides comprising a top, a bottom, and four rounded faces, the faces generally perpendicular to the top and the bottom, and   wherein at least one of the sides comprises the barrier material.   
     
     
         9 . The device of  claim 8 , wherein at least one of the sides is free of the barrier material so that the bone filler material can flow through the barrier-free side into contact with the bone. 
     
     
         10 . The device of  claim 8 , wherein the device is adapted so that at least one of the sides comprising the barrier material can be selectively oriented toward a desired portion of the bone. 
     
     
         11 . The device of  claim 5 , wherein the implantable structure further comprises:
 a frame having six sides comprising a top, a bottom, and four rounded faces, the faces generally perpendicular to the top and the bottom, the frame further comprising a plurality of frame members, each frame member connected at each end to two other of the frame members at joints between the sides,   wherein at least one of the sides of the frame comprises the first bone contact portion and at least another one of the sides of the frame comprises the second bone contact portion.   
     
     
         12 . The device of  claim 11 , the frame members further comprising shape memory material collapsible to the undeployed configuration and expandable to the deployed configuration. 
     
     
         13 . The device of  claim 11 , each of the frame members generally perpendicular to the top and the bottom comprising a flexible joint adapted to flex the frame between the undeployed configuration and the deployed configuration. 
     
     
         14 . The device of  claim 1 , wherein the implantable structure further comprises a disc of the barrier material. 
     
     
         15 . The device of  claim 14 , wherein in the undeployed configuration the disc is wrappable about an elongate member, and wherein expansion of an expandable body inside the wrapped disc causes the disc to unwrap to its deployed configuration. 
     
     
         16 . The device of  claim 14 , wherein the device is adapted so that the outer surface of the disc can be selectively oriented toward a desired portion of the bone. 
     
     
         17 . The device of  claim 14 , wherein the barrier material comprises a bioresorbable material. 
     
     
         18 . The device of  claim 14 , further comprising a perimeter,
 wherein at least a portion of the outer surface of the disc comprises a first bone contact portion and at least a portion of the perimeter of the disc comprises a second bone contact portion, and   wherein the disc comprises a sufficient rigidity such that when the first bone contact portion contacts at least a first portion of the bone from an interior of the bone and the second bone contact portion contacts at least a second portion of the bone, a load on the first portion of the bone is transferred through the structure to the second portion of the bone.   
     
     
         19 . The device of  claim 1 , the barrier material further comprising an open weave pattern adapted to reduce flow of bone filler material from the inner surface to the outer surface of the structure. 
     
     
         20 . The device of  claim 1 , the barrier material further comprising a porosity sufficient to allow nutrients to diffuse through the barrier material. 
     
     
         21 . The device of  claim 1 , the implantable structure further comprising a size capable of covering substantially all of a first portion of the bone when in the deployed configuration. 
     
     
         22 . The device of  claim 1 , the implantable structure further comprising a size capable of covering less than substantially all of a first portion of the bone when in the deployed configuration. 
     
     
         23 . The device of  claim 1 , further comprising a plurality of the implantable structures, each implantable structure adapted in the deployed configuration to prohibit substantially all flow of the bone filler material injected adjacent the inner surface of that structure to the outer surface of that structure. 
     
     
         24 . The device of  claim 1 , the implantable structure further comprising a shape memory material. 
     
     
         25 . The device of  claim 1 , further comprising radiopaque markers positioned about the structure to guide positioning of the structure relative to portions of the bone. 
     
     
         26 . A system, comprising:
 a delivery cannula having a hollow lumen and percutaneously insertable into an interior of a bone;   an elongate member insertable through the lumen of the delivery cannula;   an implantable bone barrier device comprising an outer surface and an inner surface, the device releasably attachable to a distal end of the elongate member in an undeployed configuration;   a deployment mechanism insertable through the lumen of the delivery cannula and actuatable to deploy the bone barrier device into a deployed configuration in the interior of the bone; and   a release mechanism adapted to release the bone support device from the elongate member,   wherein when the bone barrier device is in the deployed configuration, substantially all of a bone filler material injected adjacent the inner surface is prohibited from flowing to the outer surface.   
     
     
         27 . The system of  claim 26 , wherein the deployment mechanism further comprises an expandable body adapted to be disposed inside the device and to expand the device into the deployed configuration. 
     
     
         28 . The system of  claim 26 , wherein the deployment mechanism further comprises a sheath covering the device in the undeployed configuration, the sheath movable to uncover the device for deployment into the deployed configuration. 
     
     
         29 . The system of  claim 26 , further comprising a radiopaque marking pattern in communication with at least one of the delivery cannula, the elongate member, and the bone support device. 
     
     
         30 . The system of  claim 26 , further comprising a plurality of the bone barrier devices, each of the devices positionable in the deployed configuration to prohibit substantially all flow of the bone filler material injected adjacent the inner surface of that structure to the outer surface of that structure. 
     
     
         31 . A kit, comprising:
 a delivery cannula having a hollow lumen and percutaneously insertable into an interior of a bone;   a elongate member insertable through the lumen of the delivery cannula; and   an implantable bone barrier device comprising an outer surface and an inner surface, the device releasably attachable to a distal end of the elongate member in an undeployed configuration,   wherein when the bone barrier device is in the deployed configuration, substantially all of a bone filler material injected adjacent the inner surface is prohibited from flowing to the outer surface.   
     
     
         32 . The kit of  claim 31 , further comprising a deployment mechanism insertable through the lumen of the delivery cannula and actuatable to deploy the bone barrier device into a deployed configuration in the interior of the bone. 
     
     
         33 . The kit of  claim 31 , further comprising a release mechanism adapted to release the bone barrier device from the elongate member. 
     
     
         34 . The kit of  claim 31 , further comprising a plurality of the bone support devices, each of the devices positionable in the deployed configuration to prohibit substantially all flow of the bone filler material injected adjacent the inner surface of that structure to the outer surface of that structure. 
     
     
         35 . A method, comprising:
 providing an implantable bone barrier device comprising an outer surface and an inner surface, the device releasably attached in an undeployed configuration to a distal end of an elongate member;   percutaneously inserting the elongate member and attached bone barrier device into an interior of a bone;   deploying the bone barrier device into a deployed configuration;   releasing the bone barrier device from the elongate member; and   injecting a bone filler material adjacent the inner surface of the device,   wherein substantially all flow of the bone filler material from the inner surface to the outer surface of the device is prohibited.   
     
     
         36 . The method of  claim 35 , further comprising inserting an expandable body into the bone interior, and expanding the expandable body to restore height to the vertebral body. 
     
     
         37 . The method of  claim 35 , wherein deploying the bone barrier device further comprises inserting an expandable body inside the bone barrier device and expanding the expandable body. 
     
     
         38 . The method of  claim 35 ,
 wherein the bone barrier device further comprises a sheath covering the device in the undeployed configuration, and   wherein deploying the bone barrier device further comprises removing the sheath from the bone barrier device.   
     
     
         39 . The method of  claim 35 , further comprising providing a plurality of the bone barrier devices, and deploying each of the plurality of the devices to restrict flow of the bone filler material into separate portions of the bone. 
     
     
         40 . The method of  claim 35 , the bone barrier device further comprising a first bone contact portion and a second bone contact portion, the method further comprising:
 contacting at least a first portion of the bone with the first bone contact portion; and   contacting at least a second portion of the bone with the second bone contact portion such that a load placed on the first portion of the bone is transferred through the device to the second portion of the bone.   
     
     
         41 . The method of  claim 40 , the bone comprising a vertebral body,
 wherein contacting at least a first portion of the bone further comprises contacting an endplate with the first bone contact portion; and   wherein contacting at least a second portion of the bone further comprises contacting a side wall of the vertebral body with the second bone contact portion.   
     
     
         42 . The method of  claim 40 , the bone comprising a vertebral body having a first endplate opposite a second endplate,
 wherein contacting at least a first portion of the bone further comprises contacting the first endplate with the first bone contact portion, and   wherein contacting at least a second portion of the bone further comprises contacting the second endplate with the second bone contact portion.

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