US20080255569A1 - Bone support device, system, and method - Google Patents

Abstract

A bone support and/or barrier device, system, kit, and method can include an implantable structure having an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion. The structure can be collapsible to an undeployed configuration capable of percutaneous insertion to the interior of a bone and expandable to a deployed configuration in the bone. In the deployed configuration, the first bone contact portion can contact a first portion of the bone, and the second bone contact portion can contact a second portion of the bone such that a load placed on the first portion of the bone can be transferred through the implantable structure to the second portion of the bone. The implantable structure can include a barrier material adapted to restrict a bone filler material inserted into the bone adjacent the inner surface of the structure from flowing to the outer surface of the structure.

Description

FIELD OF THE INVENTION
• The present invention relates to bone support and/or barrier devices and systems, kits comprising a bone support and/or barrier device, and related methods. Embodiments of the present invention can be advantageous for providing support and/or barrier to a bone accessed by a minimally invasive technique or other surgical technique.
BACKGROUND OF THE INVENTION
• Bone may become fractured or prone to compression fracture or collapse due to various conditions, including osteoporosis, avascular necrosis, cancer, trauma, or other disease. If not successfully treated, fractured or weakened bone can result in deformities, chronic complications, and an overall adverse impact upon the quality of life.
• Minimally invasive surgical procedures have been developed that can be used to treat fractured bones. Such minimally invasive procedures can reduce pain, post-operative recovery time, and the destruction of healthy tissue. In minimally invasive surgery, the site of pathology is accessed through portals rather than through a significant incision, thus preserving the integrity of intervening tissues. These minimally invasive techniques also often require only local anesthesia.
• Minimally invasive surgical techniques are particularly desirable for spinal and neurosurgical applications because of the need for access to locations deep within the body and the danger of damage to vital intervening tissues associated with conventional “open” access techniques. The development of minimally invasive spinal procedures, for example, for repair of vertebral compression fractures, has resulted in reduced recovery time and decreased post-operative pain as such procedures require minimal, if any, muscle dissection and can be performed under local anesthesia.
• Minimally invasive procedures for reducing a vertebral compression fracture (“VCF”) can include inserting a bone tamp, such as an expandable balloon, curette, and/or other device into a vertebral body. The bone tamp can be used to create a void, or interior cavity, in the cancellous bone in the vertebral body. The void can be filled with a filling material, such as a bone cement, in order to provide interior structural support for cortical bone.
• In certain applications, it may be desirable to provide structural support to a bone structure after a void has been created inside the bone structure. For example, a bone tamp may be utilized to create a void inside a vertebral body and displace an endplate of the vertebral body to restore the height of the vertebral body. In certain clinical situations, it may be desirable to provide structural support to the endplate in order to maintain the position of the endplate after the bone tamp has been removed prior to injection of bone cement to fill the void.
• In certain disease states, such as osteoporosis, vertebral bodies may be particularly susceptible to VCF. Moreover, patients who have suffered a VCF may be at risk for additional VCFs. The occurrence or reoccurrence of VCFs may be related to collapse of an endplate into the vertebral body. Thus, in certain medical situations, it may be desirable to provide structural support to the endplate of a vertebral body to prevent the endplate from collapsing. In clinical situations in which the height of a collapsed vertebral body has been restored, it may be desirable to provide structural support to maintain the height of the endplate.
SUMMARY OF THE INVENTION
• Embodiments of the present invention can provide bone support and/or barrier devices and systems, kits comprising a bone support and/or barrier device, and related methods. Some embodiments are useful for supporting a bony structure in an interior body region in a human or animal accessed utilizing minimally invasive surgery.
• In an illustrative embodiment, the bone support device can comprise an implantable structure having an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion. A portion of the outer surface can comprise the first bone contact portion. The structure can be collapsible to an undeployed configuration capable of percutaneous insertion to the interior of a bone and expandable to a deployed configuration in the interior of the bone. In some embodiments, when the structure is in the deployed configuration, the first bone contact portion can contact at least a first portion of the bone from the interior of the bone, and the second bone contact portion can contact at least a second portion of the bone. In this manner, a load placed on the first portion of the bone can be transferred through the implantable structure to the second portion of the bone. In certain embodiments, the device can be implanted in a vertebral body such that the first bone contact portion of the device can contact an endplate and the second bone contact portion can contact cortical bone about a perimeter of the vertebral body, for example, the cortical bone in the vertebral body side wall.
• In some embodiments, the bone support device can comprise a structure that when deployed can extend between the superior endplate and the inferior endplate in a vertebral body. In this manner, a load placed on the superior endplate can be transferred through the device to the inferior endplate to provide structural support to the superior endplate. In certain embodiments, the bone support device can comprise a structure that when deployed can contact the endplate and both the cortical bone in the vertebral body side wall and the cortical bone in the inferior endplate. Such a configuration can provide structural support to the superior endplate by transferring a load from the superior endplate to both the vertebral body side wall and the inferior endplate.
• In some embodiments, the bone support device may be utilized to provide structural support to the interior of a bone without use of any additional support mechanisms, for example, injection of a bone cement. In other embodiments, the bone support device may be inserted into the interior of a bone, and a bone cement can be injected into the bone interior to provide further structural support to the bone.
• In some embodiments, the implantable structure can include a barrier material attached to the structure that is adapted to prohibit substantially all of a bone filler material inserted into the bone adjacent the inner surface of the structure from flowing to the outer surface of the structure.
• Other embodiments can comprise a system or a kit including an implantable bone support device having an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion. The device can be releasably attached to the distal end of an elongate member, such as a deployment cannula, in an undeployed configuration. Such a system or kit can further include a delivery cannula having a hollow lumen that can be percutaneously inserted into the interior of a bone. The elongate member and the attached bone support device may be inserted through the lumen of the delivery cannula to the bone interior.
• A system or kit can further include a deployment mechanism that can be inserted through the lumen of the delivery cannula and actuated to deploy the bone support device into a deployed configuration in the interior of the bone. In some embodiments, the system or kit can also include a release mechanism adapted to release the bone support device from the elongate member. Some embodiments of a system or kit can include a plurality of the implantable bone support devices, in which each of the devices can be inserted into the interior of a bone and deployed such that the deployed configurations support a separate portion of the bone.
• Some embodiments of the present invention 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 inserted into the bone from flowing through and/or around the barrier material. Such embodiments of a barrier material may prevent the undesirable flow of the bone filler material into and through a compromised portion of the bone. For example, an embodiment of a such a barrier material inserted into a void created in the interior of a vertebral body may prevent the flow of subsequently injected bone cement through and/or around the barrier material into a compromised endplate and/or vertebral body wall. In this manner, the barrier material may prevent leakage of the bone cement through the endplate and/or vertebral body wall. Such embodiments of a barrier material may be utilized without any other structural supports.
• Other embodiments can comprise a method for supporting a bone utilizing an implantable bone support device. The bone support device can comprise an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion. The device can be releasably attached to the distal end of an elongate member in an undeployed configuration. The elongate member and attached bone support device can be percutaneously inserted into the interior of a bone. In some embodiments, such a method can further include actuating a deployment mechanism to deploy the bone support device into a deployed configuration. Deploying the device into a deployed configuration can cause the first bone contact portion to contact at least a first portion of the bone from the interior of the bone, and the second bone contact portion to contact at least a second portion of the bone. In this manner, a load placed on the first portion of the bone can be transferred through the device to the second portion of the bone. For example, in certain embodiments, the device can be implanted in a vertebral body such that the first bone contact portion of the device can contact an endplate and the second bone contact portion can contact cortical bone about a perimeter of the vertebral body, for example, the cortical bone in the vertebral body side wall. Some embodiments of a method may further include selectively positioning the bone support device in a desired location and orientation in the interior of the bone prior to, during, or after actuating the deployment mechanism. In certain embodiments, a method can include releasing the bone support device from the elongate member. The elongate member may then be removed from the bone. In some embodiments, such a method may further include inserting an expandable body into the interior of a bone, such as a vertebral body, and expanding the expandable body to create a void and/or move a collapsed or partially collapsed endplate so as to restore the height of the vertebral body.
• Features of a bone support device, system, kit, and methods of the present invention may be accomplished singularly, or in combination, in one or more of the embodiments of the present invention. As will be realized by those of skill in the art, many different embodiments of a bone support device, system, kit, and method for supporting a bone according to the present invention are possible. Additional uses, advantages, and features of embodiments of the invention are set forth in the illustrative embodiments discussed in the detailed description herein and will become more apparent to those skilled in the art upon examination of the following.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side view of a bone support device system having an implantable structure attached to the distal end of an elongate member inserted through a delivery cannula in an embodiment of the present invention.
• FIG. 2 is an elevation (lateral) view of several human vertebrae, with a delivery cannula establishing a path to a vertebral body of one of the vertebrae.
• FIG. 3 is a plan (coronal) view of a human vertebra being accessed by a delivery cannula, with portions of the vertebra removed to reveal cancellous bone within a vertebral body.
• FIG. 4 is a side view of a bone support device attached to the distal end of an elongate member and a handle having a deployment mechanism attached to the proximal end of the elongate member in an embodiment of the present invention.
• FIG. 5 is a cross-sectional view of a vertebral body showing the bone support device inFIG. 4, pivoted toward an endplate in an embodiment of the present invention.
• FIG. 6A is a cross-sectional view of a vertebral body showing the bone support device inFIG. 4, fully deployed in contact with an endplate and walls of the vertebral body in an embodiment of the present invention.
• FIG. 6B is a cross-sectional view of a vertebral body showing an embodiment of the bone support device having two sets of support members, one set of support members fully deployed in contact with an endplate and walls of the vertebral body and the other set of support members fully deployed in contact with both the superior and inferior endplates, in another embodiment of the present invention.
• FIG. 7 is a view of a bone support device comprising an implantable frame structure having an outer ring and cross-members in another embodiment of the present invention.
• FIG. 8 is a cross-sectional view of a vertebral body showing a bone support device comprising a dome-shaped implantable frame structure having an outer ring and cross-members that is fully deployed in contact with an endplate and walls of the vertebral body in an embodiment of the present invention.
• FIG. 9 is a cross-sectional view of a vertebral body showing a bone support device comprising a flat-shaped implantable frame structure having an outer ring and cross-members that is fully deployed in contact with an endplate and walls of the vertebral body in an embodiment of the present invention.
• FIG. 10 is a plan (coronal) view of a human vertebra with portions of the vertebra removed showing a bone support device comprising a semi-circular-shaped implantable frame structure having an outer ring and cross-members that is fully deployed in contact with walls of the vertebral body in an embodiment of the present invention.
• FIG. 11 is a side view of a bone support device comprising an implantable frame structure having an outer ring and cross-members in an elongated, undeployed configuration in an embodiment of the present invention.
• FIG. 12 is a view of cross-members of a bone support device comprising an implantable frame structure showing the cross-members having pivotable intersections with other cross-members in an embodiment of the present invention.
• FIG. 13 is a view of the cross-members inFIG. 12, in which the cross-members have been collapsed into an undeployed configuration by pivoting at the cross-member intersections in an embodiment of the present invention.
• FIGS. 14A-C are plan (coronal) views of a human vertebra with portions of the vertebra removed and showing a delivery cannula inserted into the interior of the vertebral body using an extra-pedicular approach in an embodiment of the present invention.FIG. 14B shows a bone support device delivered on the distal end of an elongate member through the delivery cannula into the interior of the vertebral body.FIG. 14C shows the delivery cannula retracted toward the extra-pedicular entry site in the vertebral body wall and the bone support device being further deployed in the interior of the vertebral body.
• FIG. 15 is a perspective view of a bone support device comprising an implantable six-sided frame structure having pivotable joints in at least some of the frame members in an embodiment of the present invention.
• FIG. 16 is a cross-sectional view of a vertebral body showing the bone support device inFIG. 14, in a fully deployed configuration in contact with an endplate and walls of the vertebral body in an embodiment of the present invention.
• FIG. 17 is a view of the bone support device inFIG. 15, in which the frame members have been pivoted about the pivot joints into a collapsed, undeployed configuration in an embodiment of the present invention.
• FIG. 18 is a cross-sectional view of a vertebral body showing a bone support device comprising a disc of material wrapped about an elongate member in an undeployed configuration in an embodiment of the present invention.
• FIG. 19 is a cross-sectional view of a vertebral body showing the bone support device inFIG. 18, in which the disc of material is partially unwrapped by expansion of an expandable body inside the disc in an embodiment of the present invention.
• FIG. 20 is a cross-sectional view of a vertebral body showing the bone support device inFIG. 18, in a fully deployed configuration in contact with an endplate and walls of the vertebral body in an embodiment of the present invention.
• FIG. 21 is a flow chart illustrating a method for supporting a bone in an embodiment of the present invention.
• FIGS. 22A-B are cross-sectional views of a vertebral body showing a vertebral body access in the vertebral body wall in an embodiment of the present invention.
DETAILED DESCRIPTION
• Embodiments of the present invention can provide bone support and/or barrier devices, systems, and kits, and methods. Some embodiments are useful for supporting a bony structure in an interior body region in a human or animal accessed utilizing a minimally invasive surgery technique. The devices, systems, kits, and methods can be adapted for use in many suitable interior body regions, wherever the support, repair, and/or protection of one or more layers of tissue may be required for a therapeutic or diagnostic purpose. The illustrative embodiments are associated with devices, systems, kits, and methods used to treat bones. Other embodiments may be utilized in other interior body regions or with other types of tissues.
• As used in this specification and the appended claims, “proximal” is defined as nearer to a point of reference such as an origin, a point of attachment, or the midline of the body. As used in this specification and the appended claims, “distal” is defined as farther from a point of reference, such as an origin, a point of attachment, or the midline of the body. Thus, the words “proximal” and “distal” refer to, for example, direction nearer to and farther from, respectively, an operator (for example, surgeon, physician, nurse, technician, etc.) who inserts a medical device into a patient, with the distal end, or tip, of the device inserted inside the patient's body. For example, the end of a medical device inserted inside the patient's body is the distal end of the medical device, while the end of the medical device outside the patient's body is the proximal end of the medical device.
• Referring now to the figures,FIG. 1 is a view of asystem10 according to an embodiment of the present invention comprising a bone support and/orbarrier device13. Thesystem10 is configured to allow an user to deliver and/or deploy the bone support and/ordevice13 in a targeted area in an interior body region, such as the interior33 of a bone. Thesystem10 includes animplantable structure30 attached to thedistal end16 of theelongate member14 that is configured to be used, for example, in a minimally invasive procedure for repairing a vertebral compression fracture.
• As shown inFIG. 1, thesystem10 can comprise adelivery cannula11 having a proximal end and adistal end12. Thedelivery cannula11 may be fabricated from a material selected to facilitate advancement and rotation of theelongate member14 movably disposed within a hollow lumen of thedelivery cannula11. Thedelivery cannula11 can be constructed, for example, using standard flexible, medical grade plastic materials, such as vinyl, polyamides, polyolefins, ionomers, polyurethane, polyether ether ketone (PEEK), polycarbonates, polyimides, and polyethylene tetraphthalate (PET). Thedelivery cannula11 can be constructed as a bi-layer or a tri-layer of one or more of these materials. Thedelivery cannula11 can also comprise more rigid materials to impart greater stiffness and thereby aid in its manipulation and torque transmission capabilities. More rigid materials useful for this purpose include stainless steel, nickel-titanium alloys (such as Nitinol), and other metal alloys.
• The embodiment of thesystem10 shown inFIG. 1 comprises theelongate member14 movably disposed within thedelivery cannula11. Theelongate member14 can be have a hollow lumen that allows for movement of a flowable material, for example, a liquid or a gas, through theelongate member14. Theelongate member14 may be made from a resilient inert material providing torsion transmission capabilities, for example, stainless steel, a nickel-titanium alloy such as Nitinol, and other suitable metal alloys. In other embodiments, theelongate member14 may be fashioned from a variety of suitable materials, such as a carbon fiber, a glass, or a flexible material, for example, as a plastic or rubber. In an embodiment comprising a flexibleelongate member14, theelongate member14 may be formed, for example, from twisted wire filaments, such as stainless steel, nickel-titanium alloys (such as Nitinol), and other suitable metal alloys.
• Theelongate member14 may include ahandle50, for example, as shown inFIG. 4, at itsproximal end15 to aid in gripping and maneuvering theelongate member14. Such ahandle50 can be formed from a plastic or foam material and secured about theproximal end15 of theelongate member14. In some embodiments, theelongate member14, and thereby theimplantable structure30, may be in communication with a controller, such as a slide controller, a pistol grip controller (as shown inFIG. 4), a ratcheting controller, a threaded controller, or any other suitable type of controller that can be configured to permit a user of thesystem10 to control the extent to which the implantable structure of the bone support device extends beyond thedistal end16 of theelongate member14. Such a controller may permit a user of thesystem10 to manipulate theimplantable structure30, for example, to provide rotational torque and thereby control rotation of theelongate member14 and theimplantable structure30.
• Referring now toFIGS. 2 and 3, an elevation (lateral) view of severalhuman vertebrae20 is shown, with thedelivery cannula11 establishing a percutaneous path along itselongated axis52 to avertebral body21 of one of theseveral vertebrae20. Thevertebral body21 extends on the anterior (i.e., front or chest) side of thevertebrae20. Thevertebral body21 comprises an exterior formed from compactcortical bone24. Cortical bone (24) is defined as bone consisting of, or relating to, cortex, or outer layer of a bony structure. Thecortical bone24 encloses an interior volume of reticulated cancellous25, or spongy, bone (also called medullary bone or trabecular bone).
• Due to various traumatic or pathologic conditions, such as osteoporosis, avertebral body21 can experience a vertebral compression fracture (VCF). In such conditions,cancellous bone25 can be compacted, causing a decrease in height of thevertebra20. In a VCF in particular, vertebral height tends to be lost in the anterior region of thevertebral body21. The user of thesystem10 may utilize it to provide a cavity, or void, within thevertebral body21, and to restore height to thevertebral body21 lost when a fracture occurred.
• The upper and/or the lower surface of avertebral body21 with which an intervertebral disc has contact is defined as avertebral body endplate22. Eachvertebral body21 has a top, or superior,endplate22 and a bottom, or inferior,endplate22.Vertebral body endplates22 comprisecortical bone24. The perimeters of theendplates22 are reinforced due to the generally perpendicular proximity to thecortical bone24 in thewalls23 of the vertebral body. However, the tissue inside thevertebral body21 is softcancellous bone25. As a result, the middle portion of theendplates22 may not be well supported anatomically and may thus be the most susceptible to deformation and collapse.
• Thevertebral body21 is in the general shape of an oval disc. AsFIGS. 2 and 3 show, access to the interior volume of thevertebral body21 can be achieved, for example, by drilling an access portal through a rear side of the vertebral body21 (a postero-lateral approach). The portal for the postero-lateral approach enters at a posterior side of thevertebral body21 and extends anteriorly into thevertebral body21. Alternatively, access into the interior33 volume of avertebral body21 can be accomplished by drilling an access portal through one or bothpedicles26 of thevertebra20. This is known as a transpedicular approach.
• Some embodiments of the present invention, for example, thesystem10 can be configured to be used, for example, in a kyphoplasty procedure. Kyphoplasty is a minimally invasive surgical procedure for reducing a vertebral fracture and restoring height to an injured ordiseased vertebra20. In a kyphoplasty procedure, after a cavity is formed in avertebral body21, a bone filler material can be introduced into the resulting cavity to provide increased height and stability to thevertebra20.
• Applications and uses of embodiments of the bone support and/orbarrier devices13 can vary depending on various clinical factors. For example, some embodiments ofbone support devices13 and/orsystems10 of the present invention may be utilized to repair a fractured bony structure from theinterior33 of a bone. Alternatively, or in addition, some embodiments may be implanted as a preventative measure to help reduce the incidence of fractures in certain patients.
• In some embodiments, the bone support and/orbarrier device13 may be implanted into the interior of a bone alone. In other embodiments, the bone support and/orbarrier device13 may be implanted into the interior of a bone in combination with a bone filler material. For example, theexpandable body17, such as a balloon kyphoplasty bone tamp, may be utilized to create a void in thevertebral body21. After the void is created, the bone support and/orbarrier device13 may be inserted into and deployed in thevertebral body13. Once thedevice13 is in a desired position, a bone cement can be injected into the void to fill the rest of the void.
• In some clinical situations, expansion of theexpandable body17 may create enough lift to move thesuperior endplate22 in relation to theinferior endplate22, thereby restoring height to the collapsedvertebral body21. However, once theexpandable body17 is removed, thesuperior endplate22 may partially or completely collapse from its restored height. In such a situation, thebone support device13 may be implanted in thevertebral body21 to maintain the restored height of thevertebral body21.
• In some embodiments, thebone support device13 may be inserted into and deployed in the interior of thevertebral body21 along with theexpandable body17 such that once height restoration is achieved and theexpandable body17 is retracted from thevertebral body21, thebone support device13 can remain inside thevertebral body21 to provide support to theendplate22. In other embodiments, once a void is created and the height of thevertebral body21 is restored, theexpandable body17 can be removed from thevertebral body21. After theexpandable body17 is removed, thebone support device13 can be inserted to the interior of thevertebral body21 through the same percutaneous path as theexpandable body17. Once in a desired position inside thevertebral body21, thebone support device13 can be deployed to maintain theendplates22 in a position of restored height and prevent theendplates22 from migrated back towards each other. In such an embodiment, thebone support device13 can be adapted to expand with a lifting force on theendplates22 sufficient to restore the height of thevertebral body21 between theendplates22.
• In some clinical situations, it may be desirable to avoid the use of a bone filler material. Thus, in some embodiments, thebone support device13 may be deployed in thevertebral body21 without injection of a bone filler material, or cement. In other embodiments, once thebone support device13 is in position in thevertebral body21, a bone filler material may be injected into thevertebral body21 to provide further structural support to theendplates22 andvertebral body21.
• In some embodiments, thebone support device13 can be configured such that once deployed inside thevertebral body21, it can transfer a load, or force,34 exerted downward along the axis of thesuperior endplate21 towards thevertebral body walls23, thereby supporting thesuperior endplate22. In other embodiments, thebone support device13 can be configured such that once deployed inside thevertebral body21, it can transfer theload34 exerted downward along the axis of thesuperior endplate22 towards theinferior endplate22 and thus provide support to thesuperior endplate22. In still other embodiments, thebone support device13 can be configured such that once deployed inside thevertebral body21, it can support thesuperior endplate22 by transferring anaxial load34 exerted on thesuperior endplate21 towards both thevertebral body walls23 and theinferior endplate22.
• FIG. 3 shows avertebra20 being accessed by thesystem10 according to an embodiment of the present invention. Thevertebra20 is shown with portions removed to revealcancellous bone25 within thevertebral body21. The user of thesystem10 may slide theelongate member14 and attached components axially, or lengthwise, along theelongated axis52, within thedelivery cannula11 to deliver the components to the targeted treatment site.
• In a kyphoplasty procedure, or other vertebral body repair procedure, theelongate member14 can have attached to its distal end16 a device for creating a void, or cavity, in thecancellous bone25 of thevertebral body21. As shown inFIG. 3, the void-creating device can be anexpandable body17, such as an inflatable balloon, as shown inFIG. 3. In some embodiments, other apparatus and methods can be used to create a void within avertebral body21 or other bony structure. The user may rotate theelongate member14, and thereby theexpandable body17, to position theexpandable body17 for selective expansion in the target treatment area.
• After theexpandable body17 is moved beyond thedistal end12 of thedelivery cannula11, theexpandable body17 may be expanded from a contracted state to an expanded state to provide a cavity within thecancellous bone25. Theexpandable body17 may be expanded by movement of a flowable material, for example, normal saline, through the hollowelongate member14 and into the interior of theexpandable body17. Embodiments of anexpandable body17 can move the superior and/orinferior endplates22 of avertebral body21 toward a more normal anatomical position to restore height. In this manner, the outer dimensions of thevertebral body21 can be maintained an/or restored. Once a desired void has been created, theexpandable body17 may be contracted by withdrawing the flowable material out of theexpandable body17 through the hollow lumen of theelongate member14. Theelongate member14 and the contractedexpandable body17 may then be withdrawn through thedelivery cannula11.
• In a minimally invasive procedure, an embodiment of the bone support and/orbarrier device13 can be inserted percutaneously to a treatment site in a collapsed, or closed, undeployed configuration. Once the undeployed bone support and/orbarrier device13 is in a desired position in theinterior33 of a bone, thedevice13 can be expanded to a deployed configuration. The bone support and/orbarrier device13 can be expanded, or deployed, to its deployed configuration with various deployment mechanisms. One such mechanism for deploying the bone support and/orbarrier device13 from its undeployed configuration can be theexpandable body17, which may be, for example, an inflatable balloon.
• Theexpandable body17 may be attached to thedistal end16 of theelongate member14 and inserted through the lumen of thedelivery cannula11 to the target site. Theexpandable body17 can then be expanded, such as by inserting a flowable material through the hollowelongate member14 and into the interior of theexpandable body17. Expanding theexpandable body17 inside the undeployed bone support and/orbarrier device13 can cause the bone support and/orbarrier device13 to expand outwardly from its undeployed configuration into its deployed configuration. In addition, in some embodiments, expanding the bone support and/orbarrier device13 outwardly can cause thedevice13 to be moved to a desired position within a bony structure. In some embodiments, the bone support and/orbarrier device13 can be moved outwardly by other deployment mechanisms, for example, a hydraulic mechanism, by mechanical actuation, or by other suitable mechanisms and/or interfaces.
• In some embodiments of the present invention, the bone support and/orbarrier device13 can be delivered to a target area, for example, in theinterior33 of a bone, simultaneously with theexpandable device17. In such embodiments, the bone support and/orbarrier device13 can be deployed with theexpandable body17 from a first, collapsed state or configuration to a second, expanded state or configuration in the target area. In other embodiments, a void can be created with theexpandable body17 and theexpandable body17 removed. Then, the bone support and/orbarrier device13 can be delivered through thedelivery cannula11 to the target area and deployed with anexpandable device17 or other deployment mechanism.
• After theexpandable body17 is removed, a material or filler, such as a bone cement, may be used to fill the void provided by thesystem10. Use of a filler material may be beneficial in certain treatment areas, for example, in avertebra20 where thesystem10 is used to restore height to avertebral body21. Such a bone filler material can distribute an axial load34 (as shown inFIG. 6) transferred from thevertebral body21 surfaces to the hardened filler material, ultimately strengthening the spine.
• Embodiments according to the present invention are not limited in application tohuman vertebrae20, and may be used to provide support to bony structures within other parts of a living or non-living organism. In certain embodiments, thesystem10 can be utilized in various locations within the human body, depending upon the treatment goals as well as the anatomy of the targeted bone. For example, embodiments of abone support device13 and/orsystem10 may be utilized in the treatment of areas within the body other than thevertebra21, including, for example, the ribs, the femur, the radius, the ulna, the tibia, the humerus, the calcaneus, or the spine.
• One illustrative embodiment of the bone support device is shown inFIGS. 4-6B. As shown inFIG. 6A, the bone support and/orbarrier device13 can comprise a deployed configuration having an arch, or dome,shape44 similar to the shape of an opened umbrella.
• After thedelivery cannula11 has been percutaneously inserted to a target area in an interior body region, such as in avertebral body21, the bone support and/orbarrier device13 can be delivered to the target area through thedelivery cannula11. As shown inFIG. 6A, the bone support and/orbarrier device13 can be pivotably attached in a collapsed, undeployed configuration to thedistal end16 of theelongate member14 and delivered through thedelivery cannula11 to the target site. In some embodiments, thehandle50 can be attached to theproximal end15 of theelongate member14 outside a patient's body. Thehandle50 can include a mechanism that can be used to deploy thebone support device13 into a deployed configuration.
• The bone support and/orbarrier device13 may be delivered to a target surgical site using other access devices. For example, in some embodiments, the bone support and/orbarrier device13 can be delivered into a target bony structure using a conventional bone filler device (not shown). Alternatively, the bone support and/orbarrier device13 may be attached to the distal end of a modified curette (not shown) and delivered on the modified curette through thedelivery cannula11 to the target site.
• As shown in the embodiments inFIGS. 4-6B, theimplantable structure30 of the bone support and/orbarrier device13 can comprise acentral rod40 pivotably attached about apivot43 to thedistal end16 of theelongate member14. A plurality ofsupport members41 can be pivotably attached to thedistal end42 of thecentral rod40 such that thesupport members41 can be extended outwardly in a circular pattern. In the deployed configuration, the plurality of outwardly extendingsupport members41 can form an arch, ordome shape44.
• When used in a vertebral body repair procedure, the bone support and/orbarrier device13 can be positioned in a desired location within thevertebral body21, for example, in a void created in the center of thevertebral body21 between theendplates22. Once the bone support and/orbarrier device13 is in position, afirst deployment mechanism51 in thehandle50 can be actuated to pivot, or “cock,” thebone support device13, for example, approximately 90 degrees relative to thelongitudinal axis52 of theelongate member14 to point thedistal end42 of thecentral rod40 toward anendplate22. (SeeFIG. 5.) Asecond deployment mechanism53 in thehandle50 can then be actuated to extend thesupport members41 outwardly from thecentral rod40 so as to deploy thedevice13 into its operative configuration. (SeeFIGS. 6A-B.) In some embodiments, the first (rod pivoting)deployment mechanism51 can be actuated by partially depressing the trigger portion of thehandle50. The second (support member extending)deployment mechanism53 may be actuated by further depressing the trigger portion of thehandle50. Other mechanisms for deploying the bone support and/orbarrier device13 may be used. For example, ratcheted or spring-loaded mechanisms may be used to help deploy the bone support and/orbarrier device13. In some embodiments, the bone support and/orbarrier device13 can comprise a shape memory material that can facilitate deployment of the device.
• Some embodiments of the bone support and/orbarrier device13 can include a mechanism to release thedevice13 from thedistal end16 of theelongate member14 after it has been deployed and positioned in a desired position in avertebral body21. For example, one end of the bone support and/orbarrier device13 can include threads and can be threaded onto mating threads on thedistal end14 of theelongate member14. When thedevice13 is in position, theelongate member14 can be rotated so as to “unscrew” theelongate member14 from the bone support and/orbarrier device13 and release thedevice13 into thevertebral body21. In another embodiment, the bone support and/orbarrier device13 can be fit snugly over thedistal end16 of theelongate member14. When thedevice13 is in position, thedevice13 can be urged off theend16 of theelongate member14 by slightly retracting theelongate member14 such that the proximal edge of thedevice13 contacts thedistal edge12 of thedelivery cannula11, thus releasing thedevice13 into thevertebral body21. Alternative release mechanisms adapted to release thecentral rod40 from theelongate member14 can be employed.
• Some embodiments of the bone support and/orbarrier device13 can comprise animplantable structure30 having anouter surface31, aninner surface32, a firstbone contact portion35, and a secondbone contact portion36. As shown in the embodiments inFIGS. 6A-B, in its deployed configuration, theimplantable structure30 of the bone support and/orbarrier device13 can be positioned so that theouter surface31 of the arch-shaped, outwardly extendingsupport members41 contacts the center, or near the center, of theendplate22. That is, at least a portion of theouter surface31 of the outwardly extendingsupport members41 can comprise the firstbone contact portion35. When theouter surface31 of thestructure30 is in contact with theendplate22, the distal ends42 of the outwardly extendingsupport members40 can be positioned in contact withcortical bone24 about the perimeter of thevertebral body21. Thus, the distal ends42 about a perimeter of the outwardly extendingsupport members41 can comprise the secondbone contact portion36 of thedevice13.
• With theouter surface31 of thedevice13 in contact with theendplate22 and the distal ends42 of thesupport members41 in contact with thevertebral body walls23, theaxial load34 placed on theendplate22, particularly in the center of theendplate22, can be transferred through thedevice13 to the strongercortical bone24 in thevertebral body walls23. As a result, thebone support device13 can spread out theload34 on theendplate22 and distribute it more evenly across a larger area and against more rigid structures (cortical bone24) in thevertebral body21. If theaxial load34 on theendplate22 reaches an amount such that theendplate22 begins to deform, the pressure against thebone support device13 can cause thedevice13 to place more spreading force on thesupport members41. As thesupport members41 spread farther from the center of thedevice13 in a flattening manner due to theload34 transferred from theendplate22, the perimeter of thedevice13 can be pushed more tightly against thecortical bone24, which can provide support against further deformation of theendplate22.
• In some embodiments, the bone support and/orbarrier device13 can be positioned in avertebral body21 to deploy, or expand, upwardly toward asuperior endplate22 or to expand downwardly toward aninferior endplate22. Theelongate member14 can be rotated to position the bone support and/orbarrier device13 so that it is oriented in either the upward or downward position. In other embodiments, thedevice13 can include two or more sets ofsupport members41. One set ofsupport members41 can be deployed upwardly into contact with thesuperior endplate22, and another set ofsupport members41 can deployed downwardly into contact with theinferior endplate22.
• In other embodiments, each of a plurality ofbone support devices13 can be adapted in the deployed configuration to support a separate portion of the bone. For example, a firstbone support device13 can be inserted into avertebral body21 and deployed into contact with oneendplate22. Following deployment of the firstbone support device13, a secondbone support device13 can be inserted into thevertebral body21 and deployed into contact with theopposite endplate22.
• Some embodiments of abone support device13 of the present invention can provide support or protection to anendplate22 that may be weakened due to a disease process, for example, increased porosity due to osteoporosis. Such a weakenedendplate22 may be reinforced in the middle portion of theendplate22 and thus help protect against possible vertebral compression fractures. In other embodiments, thebone support device13 can provide support to an already compromised anatomical structure, such as avertebral body endplate22, while an adjacent void is being created, during reconstruction of nearby structures, and/or while a bone filler material is inserted and cured in the void.
• In some embodiments, the bone support and/orbarrier device13 can be utilized in combination with a bone filler material that can be inserted into a vertebral body void adjacent thedevice13. In some embodiments, the bone filler material, or cement, can provide structural support adjacent the bone support and/orbarrier device13 for protecting the integrity of thevertebral body21. Alternatively, the bone support device13can be utilized without a bone filler material.
• Thebone support device13 can be made from various surgical materials suitable for use in an interior body region. For example, thebone support device13 can be made from materials such as titanium, a shape memory material such as Nitinol, stainless steel, and/or polymers that are sufficiently strong to support a bony structure. In various embodiments, thebone support device13 can have a thickness sufficient to provide desired load support to anendplate22 to prevent deformation or collapse of theendplate22. For example, thedevice13, including thesupport members41, can have a thickness in the range of about 1-5 mm. The desired thickness of the device material can depend on a number of factors, including, for example, whether thedevice13 is to be permanently implanted, whether a bone filler material is to be used with thedevice13, whether thedevice13 has a lateral dimension sufficient to span anentire endplate22 or less than theentire endplate22, etc.
• In some embodiments, the bone support and/orbarrier device13 can have abarrier material37, for example, as shown inFIG. 6, connecting thesupport members41. Such a span ofbarrier material37 can provide additional support to anendplate22 or other bony structure. Thebarrier material37 can be adapted to prohibit substantially all flow of bone filler material from theinner surface32 of the deployeddevice13 to theouter surface31 of thedevice13. In this manner, thedevice13 can help prevent leakage of bone filler material through a compromised bone adjacent thedevice13. Thebarrier material37 can comprise Teflon® (polytetrafluoroethylene), Dacron®, or other implantable, biocompatible material. In an embodiment, thebarrier material37 can comprise an open weave pattern adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13.
• In certain embodiments, thebarrier material37 can have a porosity sufficient to allow nutrients to diffuse through the material37 so as to reach the interior of thevertebral body21. Alternatively, thebarrier material37 can be a biodegradable material that can provide additional support to anendplate22 for a limited period of time, after which the material degrades and is absorbed into surrounding tissue. Such a biodegradable material can include nutrients that can promote bone growth.
• In some embodiments, thebarrier material37 can be a solid tubular material, for example, a thin polymeric elastic material such as latex, placed about the exterior of thesupport members41. In an alternative embodiment, thebarrier material37 can be sheet material, such as sheets of a thin polymeric elastic material, attached and sealed toadjacent support members41. Thebarrier material37 can be attached between each pair ofadjacent support members41, or between less than each pair ofadjacent support members41. Thebarrier material37 can be attached to thedevice13 by, for example, sealing the material37 to thesupport members41 with radio frequency or laser sealing or by other suitable mechanisms.
• In an embodiment, thebarrier material37 may comprise a nanocomposite plastic material. Nanocomposites include a resin matrix and a nano-sized reinforcing filler material. Commercially available nano-fillers include clays, silicas, and ceramics. Nanocomposites and nano-fillers are available commercially from the Foster Corporation, Putnam, Conn. These fillers are small enough to improve the strength of the resin matrix so as to provide astrong barrier material37, while allowing the material37 to be extruded as a thin structure.
• Some embodiments of the bone support and/orbarrier device13 can be shaped and sized to fit a void created in the interior of a bone. In certain embodiments, the bone support and/orbarrier device13 can be sized so as to span across substantially all of anendplate22 when in a fully expanded configuration. Alternatively, the bone support and/orbarrier device13 can be sized to span less than substantially all of anendplate22 when fully expanded. For example, the fully expandeddevice13 can be sized to cover approximately half or approximately one-third of the lateral dimensions of anendplate22. Such smaller embodiments of thebone support device13 can be used individually to provide protection to a particular portion of anendplate22. Alternatively, a plurality of embodiments of the bone support and/orbarrier device13 having expanded, or deployed, dimensions less than that of the lateral dimensions of anendplate22 can be used together to provide protection for theentire endplate22. It may be desirable to use embodiments of bone support and/orbarrier devices13 having less than the full dimensions of anendplate22 when access for delivery of a largerbone support device13 to thevertebral body21 may be difficult. Rather than attempting to insert one larger bone support and/orbarrier device13, two smaller bone support and/orbarrier devices13 may be inserted, for example, onedevice13 through each pedicle of avertebra20 or via a different surgical approach.
• The embodiment of thebone support device13 inFIGS. 5 and 6 can have varying vertical dimensions, or heights, when in its fully deployed configuration. For example, thebone support device13 can have a domed orarched configuration44 such that the height at least initially gradually decreases from the center of thesupport members41 toward the perimeter of thesupport members41. As pressure from theendplate22 is transferred to thedevice13, the height at the center of thedevice13 can decrease as thesupport members41 spread out to a larger angle relative to thecentral rod40. In another embodiment, thebone support device13 can have an initial fully deployed configuration that is essentially flat about the entire lateral dimension of thedevice13.
• FIG. 6B illustrates an alternative embodiment of thebone support device13 shown inFIG. 6A. As shown in the embodiment inFIG. 6B, the umbrella-shapedbone support device13 can include the first set ofsupport members41 as described herein and a second set ofsupport members46. When thebone support device13 is in its deployed configuration, the second set ofsupport members46 can extend downward from thedistal end42 of thecentral rod40 at a more acute angle than the first set ofsupport members41. The second set ofsupport members46 can extend the entire distance between thesuperior endplate22 and theinferior endplate22 in the interior of thevertebral body21. With theouter surface31 of thebone support device13 in contact with one of theendplates22, for example, thesuperior endplate22, and the distal ends42 of the first set ofsupport members41 in contact with thevertebral body walls23, theaxial load34 placed on thesuperior endplate22 can be transferred through thedevice13 to the strongercortical bone24 in thevertebral body walls23. In addition, with the distal ends42 of the second set ofsupport members46 in contact with the opposite,inferior endplate22, theload34 placed on thesuperior endplate22 contacting theouter surface31 can be transferred through thedevice13 to the strongercortical bone24 in theinferior endplate22. As a result, thebone support device13 can spread out theload34 on thefirst endplate22 and distribute it more evenly across a larger area and against more rigid structures (cortical bone24) in thevertebral body21.
• Another embodiment of thebone support device13 is shown inFIGS. 7-13. In such an embodiment, thebone support device13 can comprise animplantable structure30 comprising aframe60 having anouter ring61 and a series ofcross-members62 each extending from one point on theouter ring61 to another, generally opposite point on thering61. The configuration of theouter ring61 and the cross-members62 can form an open weave, or grid, pattern. An open weave pattern has the advantage of allowing nutrient transfer to the adjacent intervertebral disc.
• One side of the grid ofcross-members62 can comprise theouter surface31 of theimplantable structure30, and the opposite side of the grid ofcross-members62 can comprise theinner surface32. Theouter surface31 of the cross-members62 can comprise the first bone contact portion of thedevice13 that can contact a first bone portion in the interior of a bone, for example, anendplate22 in avertebral body21. Theouter ring61 can comprise the second bone contact portion that can contact a second bone portion, for example,cortical bone24 about the perimeter of thevertebral body21. In this manner, aload34 placed on the first portion of the bone can be transferred through theimplantable structure30 to the second portion of the bone, thereby supporting the first bone portion.
• Embodiments of thebone support device13 having theouter ring61 and a grid ofcross-members62 can have various configurations. For example, as shown inFIG. 7, theouter ring61 can have a circular oroval shape65. In some embodiments, thebone support device13 comprising theouter ring61 and a grid ofcross-members62 can be configured to have an arched “dome” shape66, as shown inFIG. 8, when thedevice13 is deployed inside an internal body region. Such a dome shape66 can aid in the transfer of theaxial load34 from theendplate22 by providing a biased contact between the archedouter surface31, or convex surface63, of the cross-members62 and theendplate22. In addition, such a dome shape66 can allow the perimeter of theouter ring61 to engagecortical bone24 along thevertebral walls23 in a biased manner. As a result, theload34 can be transferred from the supportedendplate22 tocortical bone24 in another vertebral body structure so as to provide a greater resistance to the load stress in theendplate22. In an embodiment in which theouter ring61 does not initially engage one or more surfaces of thevertebral walls23, as pressure from theendplate22 is exerted on the upper, convex surface63 of the cross-members62, the remainder of thedevice13 may spread outwardly toward and into contact withcortical bone24 in the walls of thevertebral body21. In this manner, support from thecortical bone24 in thevertebral body walls23 can stop further inward movement of theendplate22. The transfer of load stress from theendplate22 can help protect theendplate22 from undergoing a compression fracture or from experiencing extension of an existing fracture.
• Another embodiment of thebone support device13 comprising theouter ring61 andcross-members62 can have an essentiallyflat configuration67, as shown inFIG. 9. In such an embodiment, thedevice13 can be delivered into thevertebral body21 and deployed so as to be positioned into contact with both anendplate22 andcortical bone24 in thewalls23 of thevertebral body21. That is, thedevice13 may be deployed into direct contact with theendplate22 without further positioning (such as rotating approximately 90 degrees as with the embodiment shown inFIGS. 4-6). In such aflat configuration67,load pressures34 exerted on theendplate22 can be transferred through the structure of thedevice13 to thecortical bone24 in thevertebral body walls21.
• In another embodiment, as shown inFIG. 10, theouter ring61 can be in the shape of a semi-circle68 with one side of the semi-circle68 being a flat portion of theouter ring61 and the remainder of the semi-circle68 being an arcuate, circumferential edge connected to the ends of the flat portion of theouter ring61. In this configuration, the cross-members62 can extend from the flat side of theouter ring61 to the arcuate, circumferential edge of theouter ring61. Asemi-circular configuration68 may be advantageous for conforming to the interior of certain bony structures, such as avertebral body21.
• Some embodiments of thebone support device13 comprising theouter ring61 andcross-members62 can have other configurations that are suitable for displacingaxial load pressures34 on anendplate22 to other bony structures (such as cortical bone24). The design, shape, or configuration of thebone support device13 comprising theouter ring61 andcross-members62 can vary depending on a number of factors, including, for example, the type of anatomical structure intended for support and protection, the materials used to make thedevice13, the type of deployment apparatus, the location of the target site, whether access to the target site is via open surgery or by minimally invasive techniques, and others.
• In certain embodiments, thebone support device13 comprising theouter ring61 andcross-members62 can be sized so as to span across substantially all of anendplate22 when in a deployed configuration. Alternatively, thebone support device13 can be sized to span less than substantially all of anendplate22 when fully deployed. In some embodiments, a plurality of thebone support devices13 can be used together to provide support to particular portions of theendplate22 or other bony structure(s).
• In some embodiments, thebone support device13 can be delivered into the interior of thevertebral body21 through various locations in thevertebral body wall23 relative to theendplate22. For example, embodiments of thebone support device13 can be delivered into thevertebral body21 interior at a location in thevertebral body wall23 near theendplate22 such that thebone support device13 can be deployed adjacent theendplate22. As shown inFIGS. 22A and 22B, in certain embodiments, avertebral body access27 can be made in thevertebral body wall23 near theendplate22. Thedelivery cannula11 can be inserted through thevertebral body access27, and thebone support device13 can be delivered through thedelivery cannula11 into the interior of thevertebral body21.
• When thevertebral body access27 is located in the vertebral body wall near theendplate22, as shown inFIGS. 22A and 22B, thebone support device13 can be delivered into thevertebral body21 interior in a position adjacent theendplate22. In certain embodiments, thebone support device13 may be delivered through thevertebral body access27 such that thebone support device13 can be positioned in contact with both theendplate22 andcortical bone24 in thewalls23 of thevertebral body21. That is, thedevice13 may be deployed into direct contact with theendplate22 without further positioning. As shown inFIGS. 22A and 22B, the dimensions of thevertebral body access27 can vary. For example, thevertebral body access27 may extend along the majority of the lateral side of thevertebral body21, as in the embodiment inFIG. 22A. In another embodiment, thevertebral body access27 may extend along a shorter portion, for example, less than half, of the lateral side of thevertebral body21, as in the embodiment inFIG. 22B.
• Embodiments of thebone support device13 comprising theouter ring61 andcross-members62 can comprise various materials, including, for example, shape memory materials such as Nitinol or shape-memory plastics. Thebone support device13 can comprise materials that impart suitable rigidity to provide structural support to the target bony structure.
• In some embodiments, the bone support and/orbarrier device13 comprising an outer ring and cross-members can have abarrier material37, for example, as shown inFIGS. 7,8, and10, connecting the cross-members62. Such a span ofbarrier material37 may provide additional support to anendplate22 or other bony structure. Thebarrier material37 can be adapted to prohibit substantially all flow of bone filler material from the inner surface32 (such as the inner concave surface of the dome-shaped device inFIG. 8) of the deployeddevice13 to theouter surface31 of thedevice13. In this manner, thedevice13 can help prevent leakage of bone filler material through a compromised bone adjacent thedevice13. In an embodiment, thebarrier material37 can comprise an open weave or mesh design adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. In such an embodiment, the bone barrier device can reduce the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13, while allowing the flow of some bone filler material through thebarrier material37, which can contact and bond with a bony structure adjacent theouter surface31 of thedevice13. In yet another embodiment, the bone support and/orbarrier device13 can include through holes in either the cross-members62 or thebarrier material37, or both, so that the bone filler material can penetrate through thedevice13 to fill the space in the void both adjacent theinner surface32 and adjacent theouter surface31 of thedevice13.
• Some embodiments of the bone support device comprising an outer ring and cross-members can be inserted into an interior body region such as a vertebral body via a minimally invasive technique. For example, thedelivery cannula11 having a hollow lumen can be percutaneously inserted to the interior of a vertebral body. Thebone support device13 can be releasably attached in an undeployed configuration to thedistal end16 of theelongate member14. Theelongate member14 and the attachedbone support device13 can be inserted through the lumen of thedelivery cannula11 into the vertebral body. When thebone support device13 is in a desired position in the vertebral body, the device can be deployed into a deployed configuration into contact with the endplate, vertebral body walls, and/or other bony structures in the vertebral body. Then, thebone support device13 can be released from theelongate member14, and theelongate member14 anddelivery cannula11 removed from the vertebral body.
• Some embodiments of thebone support device13 comprising an outer ring and cross-members can be collapsed from a deployed, or expanded, configuration to an undeployed, or collapsed, configuration have a geometry sized and shaped so as to fit through the lumen of thedelivery cannula11.
• In some embodiments, the cross-members62 can be configured to extend in different directions relative toother cross-members62. For example, in some embodiments, as shown inFIGS. 7,8,10, and11, the cross-members62 can be configured to extend from one position to another position on theouter ring61 in a substantiallyparallel relationship69 to each other. In other embodiments, for example, as shown inFIGS. 12 and 13, the cross-members62 can be configured to extend so as to intersect with other cross-members62 and form an open weave pattern. The cross-members62 can be configured in any pattern suitable for providing structural support to a bony structure, such as avertebral body endplate22, and that is amenable to being percutaneously inserted into an interior body region in an undeployed, or collapsed, configuration.
• In one embodiment, as shown inFIG. 11, thebone support device13 comprising theouter ring61 andcross-members62 can be extended, or “stretched,” along its longitudinal axis so as to form a more narrow,elongated configuration71 that can be inserted through thedelivery cannula11.FIGS. 12 and 13 show another embodiment of a cross-member design, in which the cross-members62 can have an expanded, deployed configuration in which the cross-members62 are aligned at approximately right angles relative to each other in an open weave, or “X-shaped” pattern. The cross-members62 can be pivotably connected atintersections72 at which they cross. By mechanically pulling on the ends of the cross-members62, the cross-members62 can be pivoted about theintersections72 such that the cross-members62 can collapse to a nearlyparallel relationship69.FIG. 13 shows the cross-members62 in an intermediate position between a deployed configuration as inFIG. 12 and a fully collapsed, undeployed configuration. In this manner, thebone support device13 having theouter ring61 andcross-members62 can be collapsed into an undeployed configuration so as to fit through the lumen of thedelivery cannula11 for insertion into an interior body region. Once thebone support device13 is inserted into the interior body region, such as thevertebral body22, a force can be exerted against at least one of the ends of the collapsed cross-members62 so as to mechanically push, or expand, the cross-members62 back into their original deployed configuration.
• Expansion of the bone support and/orbarrier device13 from an undeployed configuration to a deployed configuration may be facilitated by using a shape memory material, such as Nitinol or shape-memory plastics, in thedevice13. When thedevice13 is in a desired position in avertebral body22, heat from the patient's body can cause the shape memory material to deploy into its expanded deployed configuration.
• In some embodiments, the implantable bone support and/orbarrier device13 can be delivered to the interior of thevertebral body21 by a trans-pedicular approach, as shown inFIGS. 5-6,8-10,15, and17-19. In an alternative embodiment, as shown inFIGS. 14A-14C, the bone support and/orbarrier device13 can be delivered to the interior of thevertebral body21 by an extra-pedicular approach. As shown inFIG. 14A, in an extra-pedicular approach, thedelivery cannula11 may be inserted into and positioned within thevertebral body21 from a position lateral to one of the vertebral body pedicles26. As an example,FIG. 14B illustrates thedelivery cannula11 in place in thevertebral body21 using an extra-pedicular approach. Theelongate member14 can be inserted through thedelivery cannula11 such that the bone support and/orbarrier device13 attached to thedistal end16 of theelongate member14 can be deployed inside thevertebral body21. The embodiment of the bone support and/orbarrier device13 illustrated inFIGS. 14B and 14C is the embodiment of thedevice13 comprising theframe60 having the outer ring61and thecross members62 shown inFIGS. 7,8, and11. As shown inFIG. 14B, thebone support device13 can have the elongatedconfiguration71 while being inserted through thedelivery cannula11, and may be extended beyond thedistal end16 of thedelivery cannula11 into the interior of thevertebral body21. As thedelivery cannula11 is retracted from its previous position shown inFIG. 14B, toward thevertebral body wall23, as shown inFIG. 14C, thebone support device13 may be fully extended beyond thedelivery cannula11 such that thedevice13 can be positioned into a fully deployed configuration. Thebone support device13 may be fully deployed in various manners, such as using a mechanical deployment mechanism, for example, the deployment mechanism actuated by thehandle50 shown inFIG. 4, or by self-deploying mechanisms, for example, as may be facilitated with the use of shape-memory material(s) in thedevice13. Thebone support device13 shown inFIGS. 14A-14C delivered into the interior of thevertebral body21 may be fully deployed into a configuration similar to that shown inFIG. 8.
• An extra-pedicular insertion approach may be useful for delivery of the bone support and/orbarrier device13 having dimensions that require a relatively large percutaneous insertion path into thevertebral body21. For example, in some surgical procedures in which only an expandable body such as a balloon is inserted into thevertebral body21, thedelivery cannula11 may be relatively small and the percutaneous insertion path can likewise be relatively small. A trans-pedicular insertion approach may accommodate such a relativelysmall delivery cannula11. For procedures that include implanting an embodiment of the bone support and/orbarrier device13, thedelivery cannula11 may need to be larger than thedelivery cannula11 required for delivering only an expandable body. In such procedures, a trans-pedicular approach may not be desirable for inserting such alarger delivery cannula11. Accordingly, an extra-pedicular insertion approach may better accommodate insertion of a relatively larger delivery cannula11 (and bone support and/orbarrier device13, for example) into the interior of thevertebral body21. In addition, an extra-pedicular approach may allow insertion of the bone support and/orbarrier device13 in a position closer to and/or more closely aligned with, theendplate22, for example, as shown inFIG. 9.
• As shown inFIGS. 11,17, and18, the bone support and/orbarrier device13 can include one or moreradiopaque markers70 that can be visualized under fluoroscopy. Radiopaque is defined as being opaque to radiation and especially x-rays. Fluoroscopy is defined as examination by means of a fluoroscope. A fluoroscope is a device equipped with a fluorescent screen on which the internal structures of an optically opaque object, such as the human body, may be viewed as shadowy images formed by the differential transmission of x-rays through the object.
• Theradiopaque markers70 can be arranged in a radiopaque marking pattern that can be configured to allow for radioscopically visualizing the positioning and orientation of thedevice13 in the interior body region during deployment. As a result, a non-radiopaque contrast medium can be used, for example, to expand theexpandable body17, thereby eliminating the risk of exposing a patient to a radiopaque contrast agent.
• In some embodiments, the radiographic marking pattern can provide essentially an outline of the shape of the bone support and/orbarrier device13 when expanded. Thus, in addition to fluoroscopically monitoring the bone support and/orbarrier device13 as it is being deployed, when thedevice13 is expanded to its deployed configuration, the periphery of thedevice13, and thereby the outer contact points of the bone support and/orbarrier device13 onto tissue in the interior body region can be visualized radioscopically.
• In some embodiments of the present invention, in addition to the bone support and/orbarrier device13, at least a portion of thedelivery cannula11,elongate member14, and/orexpandable body17 may comprise one or more radiographic material(s) and/ormarkers70. In this manner, positioning of the components used to deliver and deploy the bone support and/orbarrier device13 can be visualized radioscopically during use. As such, the user can monitor positioning of the entire bonesupport device system10 and any differences in positioning of one component relative to the other component.
• Radiopaque markers70 can be made from radiopaque materials. Examples of radiopaque materials include stainless steel, platinum, gold, calcium, tantalum, barium sulfate, tantalum, tungsten, bismuth subcarbonate, and other metals.
• FIGS. 15-17 illustrate another embodiment of a bone support and/orbarrier device13. As shown in this embodiment, thedevice13 can be configured to guide and or control the distribution of bone filler material injected into the interior of a bone. In some embodiments, the bone support and/orbarrier device13 can comprise an implantable sheet ofbarrier material37 having six sides comprising a top81, a bottom82, and fourrounded faces83, as shown inFIGS. 15-17. The faces83 can be generally perpendicular to the top81 and the bottom82 of the sheet ofmaterial37.
• The six-sided sheet ofbarrier material37 can have the appearance of a rounded cube-like structure. The rounded nature of the top81, bottom82, and faces83 of the sheet ofbarrier material37 allows the sheet ofbarrier material37 to more closely fit the contours of a void created inside a bony structure, such as avertebral body21. In its deployed configuration, theouter surfaces31 of the top81 and bottom82 of the sheet ofbarrier material37 may be positioned into contact with selected portions of the interior of the bone, for example, the superior andinferior endplates22 in avertebral body21, and theouter surfaces31 of thefaces83 may contact thevertebral body walls23. In other embodiments, the sides of the sheet ofbarrier material37 may be positioned so as to be free of contact with the interior of the bone into which it is delivered. With the sheet ofbarrier material37 of the bone barrier device in a desired position, the distribution of bone filler material injected into the interior of thevertebral body21 can be guided and/or controlled. In this manner, the sheet ofbarrier material37 can prohibit substantially all flow of bone filler material from the inner surface32 (inside) of thematerial37 of the deployeddevice13 to theouter surface31 of thematerial37. In this manner, thedevice13 can help prevent leakage of bone filler material through a compromised bone adjacent thebarrier material37.
• In an embodiment, the sheet ofbarrier material37 can comprise an open weave pattern adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. For example, the sheet ofbarrier material37 may comprise an open weave, mesh, and/or through hole configuration that is sufficiently fine to contain most of the flowable bone cement injected inside thebarrier material37 to prevent leakage outside thevertebral body21 and still allow enough bone cement to penetrate thebarrier material37 so as to form a bond with the adjacentcortical bone24.
• In certain embodiments, thebarrier material37 can be a contiguous sheet of material. Thebarrier material37 can comprise Teflon®, Dacron®, or similar biocompatible material. In some embodiments, the top81, bottom82, and/or faces83 of the sheet ofbarrier material37 of thebone barrier device13 can comprise a barrier material that can allow flow of fluids and nutrients through the material.
• In some embodiments, the sheet ofbarrier material37 can comprise one or more sides of thebone barrier device13. As such, thebone barrier device13 can be utilized to selectively restrict movement of a flowable material in various directions. By restricting the area into which a flowable material can move while being injected and cured, spread of the flowable material out of a void or bony structure, such as through a structurally compromisedendplate22 and/or vertebralbody side wall23, into undesired areas can be minimized or prevented.
• In various embodiments of a such a six-sidedbone barrier device13, from one to five sides of thedevice13 can be open (without barrier material37), all sides can be open, or no sides can be open. An open side of thebone barrier device13 can be oriented toward a portion of a bony structure, such as avertebral body wall23, so that when bone cement is injected into the void inside thevertebral body21, the bone cement can flow into contact with thevertebral body wall23 adjacent the open side. In this manner, the bone cement can “interdigitate” with thecortical bone24 in the exposedwall23 of thevertebral body21 to form a bond with thebone24, thereby providing a more stable support to thevertebral body21.
• In embodiments in which one to five sides are open withoutbarrier material37, thebone barrier device13 can be oriented so that open side(s) are facing compromised portion(s) of the endplate(s)22 and/or vertebral body wall(s)23 so as to contain flowable bone cement when it is injected into the void inside thevertebral body21. In embodiments in which no sides are open, bone cement can be prevented from contacting anycortical bone24 surface inside thevertebral body21. Although in embodiments with no open sides the bone cement cannot form a bond withcortical bone24, the presence of the cured bone cement can provide structural support to thevertebral body21. Embodiments of a totally closed-sidedbone support device13 may be desirable in a procedure to repair a vertebral compression fracture in which theendplates22 and a large portion of thevertebral wall23 are compromised and there is risk of bone cement leakage from multiple locations about thevertebral body21.
• In certain embodiments, the bone support and/orbarrier device13 comprising a sheet ofbarrier material37 may have less than six sides. For example, the bone support and/orbarrier device13 may have from one to five sides. In each of the embodiments of thedevice13 having from one to six sides, the sheet ofbarrier material37 can provide a mechanism by which the distribution of bone filler injected into or adjacent thebarrier material37 can be guided and/or controlled.
• During a procedure to repair a vertebral compression fracture, bone filler material, such as a bone cement, may be inserted into thevertebral body21 to provide structural support to thevertebral body21. In situations in which the fracture compromises the integrity of theendplate22 or thewall23 of thevertebral body21, there may be a risk that the bone cement can leak from the compromised bone. Bone cement leakage can produces symptoms, including painful irritation of a nerve root emerging from the spinal column, degeneration of the walls of major vessels, and possibly degeneration of the compromised endplate(s)22. Thus, some embodiments of the bone support and/orbarrier device13 of the present invention can provide the advantage of preventing leakage of bone cement into undesired areas.
• As shown inFIGS. 15-17, the top81, bottom82, and fourrounded faces83 of the six-sided bone support and/orbarrier device13 can be formed about animplantable frame80. Theframe80 can be configured such that thefaces83 can be generally perpendicular to the top81 and the bottom82 of thedevice13. Theframe80 can include a plurality offrame members84. Each of themembers84 can be connected at each end to two other of theframe members84 atjoints85 between the sides. In some embodiments, thebarrier material37 can be a contiguous sheet of material connected to theframe members84. In other embodiments, a separate sheet of thebarrier material37 can be attached to one or more sides of thedevice13.
• In some embodiments, the bone support and/barrier device13 can be positioned inside the bone into which it is delivered so that when theframe80 is in its fully deployed position, the sheet ofbarrier material37 can be free of contact with the bone. In other embodiments, in the fully deployed configuration, theouter surface31 of at least one side of theframe80 can contact thefirst bone portion35 inside a bony structure, and theouter surface31 of at least another side can contact thesecond portion36 of the bone so as to provide support to the first bone portion. For example, theouter surfaces31 of the top81 and bottom82 of theframe80 can be positioned in contact with the superior andinferior endplates22 in avertebral body21, and theouter surfaces31 of thefaces83 can contact thevertebral body walls23. As such, theaxial load34 placed on theendplate22 can be transferred from theendplate22 through theframe80 to thevertebral body walls23, thereby providing support to theendplate22. In each of these embodiments, the sheet ofbarrier material37 can provide a mechanism by which the distribution of bone filler injected into or adjacent thebarrier material37 can be guided and/or controlled.
• In some embodiments, theframe members84 on at least opposing sides of theframe80 can includepivot joints86 near the center of theframe members84. The pivot joints86 allow theframe members84 to pivot at the pivot joints86 so as to allow the bonesupport device frame80 to be collapsed to an undeployed configuration. For example, as shown inFIG. 17, in an embodiment in which theframe members84 on opposite ends of theframe80 include pivot joints86, exerting a force on thoseframe members84 can cause the top and bottom portions of thoseframe members84 to pivot about the pivot joints86 and fold into a generally parallel relationship with each other. As a result, the ends of theframe80 having the pivot joints86 can be collapsed so that the top81 and bottom82 of theframe80 are adjacent each other. Theframe members84 on the ends of the top81 and bottom82 of the frame80 (which include pivot joints86) can be pivoted about those pivot joints86 such that opposite sides of thoseframe members84 can be folded together. Pivoting the ends of the top81 and bottom82 of theframe80 can cause the remaining non-adjacent sides to be collapsed adjacent each other. As a result, theframe80 can be collapsed into an undeployed configuration for delivery into an interior body region. In addition, the pivot joints86 can provide the sides of theframe80 with a sufficient degree of flexibility to allow the sides to conform to possibly uneven surfaces inside a void in avertebral body21.
• In embodiments of the six-sided bone support and/orbarrier device13 comprising animplantable frame80, one or more sides of theframe80 and sheet ofbarrier material37 can be open. In embodiments in which all sides are open, thebone barrier device13 includes nobarrier material37, and bone cement can flow into contact with allcortical bone24 surfaces inside thevertebral body21. In embodiments of a totally open-sided frame80, theframe members84 can provide support to theendplates22 as well as to thevertebral body walls23.
• Some embodiments of the bone support and/orbarrier device13 having from one to six sides can be inserted into an interior body region such as avertebral body21 via a minimally invasive technique. For example, thedelivery cannula11 having a hollow lumen can be percutaneously inserted to the interior33 of thevertebral body21. The bone support and/orbarrier device13 can be releasably attached in an undeployed configuration to thedistal end16 of theelongate member14. Theelongate member14 and the attached bone support and/orbarrier device13 can be inserted through the lumen of thedelivery cannula11 into thevertebral body21. When the bone support and/orbarrier device13 is in a desired position in thevertebral body21, thedevice13 can be deployed into a deployed configuration into contact with theendplate22,vertebral body walls23, and/or other bony structures in thevertebral body21. Then, the bone support and/orbarrier device13 can be released from theelongate member14, and theelongate member14 anddelivery cannula11 removed from thevertebral body21.
• The bone support and/orbarrier device13 can be expanded to a desired deployed configuration using various apparatus and techniques. For example, some embodiments of the bone support and/orbarrier device13 may be expanded into the deployed configuration with theexpandable body17, such as an inflatable balloon tamp. Theexpandable body17 can be pre-positioned inside the bone support and/orbarrier device13 and delivered to the target bony structure at the same time thebone support device13 is delivered. Alternatively, the bone support and/orbarrier device13 can be first delivered to the target bony structure, after which theexpandable body17 can be delivered through thedelivery cannula11 to inside the bone support and/orbarrier device13 in the target bony structure. From inside the bone support and/orbarrier device13, theexpandable body17 can be expanded to thereby expand the bone support and/orbarrier device13 to its deployed configuration.
• In some embodiments, theexpandable body17 can be utilized to position and/or orient the bone support and/orbarrier device13 in the bony structure. For example, the bone support and/orbarrier device13 can be partially expanded with theexpandable device17 and oriented into a desired position such that a closed side of thedevice13 comprisingbarrier material37 is facing the portion(s) of the surrounding structures into which it is desired to prevent flow of a flowable material. Theexpandable device17 can then be further expanded to fully deploy the bone support and/orbarrier device13. With the bone support and/orbarrier device13 in place, theexpandable body17 can be deflated and removed. In other embodiments, the bone support and/orbarrier device13 can be oriented to a desired position relative to areas within a bony structure in which it has been delivered in other manners and using other apparatus. Once thedevice13 is fully deployed and positioned, thedevice13 can be released from theelongate member14. The void can then be filled with a flowable bone filler material through thedelivery cannula11.
• In some embodiments, the collapsed, undeployed bone support and/orbarrier device13 can be covered with a sheath (not shown) during delivery through thedelivery cannula11 to the target site. Such a sheath can help maintain thedevice13 in its undeployed configuration during delivery into the target bony structure. Once the bone support and/orbarrier device13 is in position in the bony structure, the sheath can be removed from around the bone support and/orbarrier device13 and retracted through thedelivery cannula11. When the sheath is removed from about the bone support and/orbarrier device13 inside the target bony structure, thedevice13 can be expanded to its deployed configuration.
• In certain embodiments, the bone support and/orbarrier device13 can comprise a shape memory material, such as Nitinol. The sheath can help maintain thedevice13 comprising shape memory material in its undeployed configuration during delivery into a target bony structure. When the bone support and/orbarrier device13 comprising a shape memory material is delivered to the target site inside a sheath and the sheath is removed from the bone support and/orbarrier device13, thedevice13 can expand to it deployed configuration without further manipulation. That is, the normal temperature of the patient's body can warm the shape memory material sufficiently to cause the bone support and/orbarrier device13 to expand to its deployed configuration.
• The bone support and/orbarrier device13 comprising the six-sided frame80 can includeradiopaque markers70, as shown inFIG. 17. Theradiopaque markers70 can be arranged in a radiopaque marking pattern that can be configured to allow for radioscopically visualizing the positioning and orientation of thedevice13 in the interior body region. For example, theradiopaque markers70 can be arranged to provide essentially an outline of one or more of the sides of the bone support and/orbarrier device13 when expanded. In this manner, the user can directly monitor positioning of those sides of the bone support and/orbarrier device13 relative to various portions of the bony structure while deploying thedevice13.
• In certain embodiments, the bone support and/orbarrier device13 comprising theframe80 having one to six sides can be sized so as to span across substantially all of avertebral body endplate22 when in its deployed configuration. Alternatively, the bone support and/orbarrier device13 can be sized to span less than substantially all of anendplate22 when fully deployed. In some embodiments, a plurality of the bone support and/orbarrier devices13 can be used together to provide support to particular portions of theendplate22 or other bony structure(s).
• FIGS. 18-20 illustrate another embodiment of the bone support and/orbarrier device13 configured to guide and or control the distribution of bone filler material injected into the interior of a bone. In this embodiment, the bone support and/orbarrier device13 can comprise adisc90 of material that can be deployed into the interior of a bone. “Disc” refers to the deployed configuration of thedevice13, which can be, for example, an oval65, circular, semi-circular68, dome66, tubular, or U-shaped configuration. Thedisc90 can have anouter surface31 and aninner surface32.
• In some embodiments, the bone support and/orbarrier device disc90 can comprise abarrier material37 adapted to restrict flow of bone filler material from theinner surface32 to theouter surface31 of thedisc90 without providing any additional structural support to a bony structure. That is, thebarrier material37 comprising thedisc90 can be a flexible, non-rigid material. For example, the bone support and/orbarrier device disc90 comprising pliable, non-rigid material can be deployed adjacent a compromised area within avertebral body21, such as a fracturedendplate22, before filling a void in thevertebral body21 with bone cement. In this manner, the bonebarrier device disc90 can help support the integrity of such a compromised bony structure by helping prevent leakage of bone cement from thevertebral body21.
• In some embodiments, thebone barrier device13 may be deployed such that thedisc90 contacts no portion of bone. For example, when thebone barrier device13 is deployed inside thevertebral body21, thedisc90 may be positioned such that thedisc90 material is free from contact with theendplates22 and/or thevertebral body walls23.
• In other embodiments, thebone barrier device13 may be deployed such that thedisc90 can contact the first portion ofbone35 and/or the second portion ofbone36. For example, thebone barrier device13 may be deployed into a position such that a portion of theouter surface31 of thedisc90 may contact the vertebral body endplate22 (that is, the first bone portion35). Theperimeter91 of the bonebarrier device disc90 can extend away from theendplate22. In an embodiment, the perimeter of thedisc90 can contact thecortical bone24 of the vertebral body walls23 (that is, the second bone portion36), which may help maintain thedevice13 in a desired position.
• In an alternative embodiment, thedisc90 can comprise a sufficient rigidity such that theaxial load34 placed on the first portion of the bone (endplate22) can be transferred through the bonesupport device disc90 to the second portion of the bone (vertebral body walls23), thereby providing support to the first bone portion (endplate22).
• Embodiments of the bonebarrier device disc90 can have various deployed configurations. For example, the deployeddisc90 configuration can be oval65, circular, semi-circular68, dome66, tubular, or U-shaped configuration. In an embodiment in which the bone support and/orbarrier device disc90 comprises a tubular shape, thedisc90 can be oriented such that opposing sides of thetubular disc90 can contact the superior andinferior endplates22 in thevertebral body21. Such a bone support and/orbarrier device disc90 having oppositely oriented sides may be desirable for use in avertebral body21 in which both superior andinferior endplates22 are compromised.
• Some embodiments of the bone support and/orbarrier device13 may be permanently implanted in the interior of a bone. In embodiments in which the bone support and/orbarrier device disc90 can be left permanently in place, thedevice13 can be made from biocompatible materials such as stainless steel, a flexible metal alloy such as Teflon®, and/or shape memory materials such as Nitinol. In other embodiments, the bone support and/orbarrier device disc90 may be made from bioresorbable materials, such as bioresorbable polymers, such that thedevice13 can eventually resorb into the surrounding tissue.
• Thedisc90 material can comprise abarrier material37 adapted to prohibit substantially all flow of bone filler material from theinner surface32 of thedisc90 of the deployed device to theouter surface31 of thedisc90. In this manner, thedevice13 can help guide and or control the distribution of bone filler material as it is injected into a void in the bone and prevent leakage of the bone filler material through a compromised bony structure adjacent thedisc90. In an embodiment, thebarrier material37 can comprise an open weave pattern adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. For example, thebarrier material37 may comprise an open weave, mesh, and/or through hole configuration in which the open area is sufficiently fine to contain most of the flowable bone cement injected adjacent theinner surface32 of thedisc90 to prevent leakage outside thevertebral body21 and still allow enough bone cement to penetrate thebarrier material37 so as to form a bond with the surface of thecortical bone24 adjacent theouter surface31 of thedisc90. In some embodiments, thebarrier material37 can have a porosity sufficient to allow nutrients to diffuse through thebarrier material37. Thebarrier material37 can comprise Teflon®, Dacron®, or similar biocompatible material.
• Some embodiments of the bone support device and/orbarrier disc90 can be inserted into an interior body region such as avertebral body21 via a minimally invasive technique. For example, thedelivery cannula11 having a hollow lumen can be percutaneously inserted to the interior of avertebral body21. The bone support and/orbarrier device disc90 can be releasably attached in an undeployed configuration to thedistal end16 of theelongate member14. Theelongate member14 and the attached bone support and/orbarrier device disc90 can be inserted through the lumen of thedelivery cannula11 into thevertebral body21. When the bone support and/orbarrier device disc90 is in a desired position in thevertebral body21, thedisc90 can be deployed into a deployed configuration, for example, into no contact with bone, or into contact with theendplate22,vertebral body walls23, and/or other bony structures in thevertebral body21. Then, the bone support and/orbarrier device disc90 can be released from theelongate member14, and theelongate member14 anddelivery cannula11 removed from thevertebral body21. With the bone support and/orbarrier device disc90 in a desired position, for example, adjacent thetarget endplate22, a bone filler material can be injected into the void in thevertebral body21 adjacent theinner surface32 of thedisc90. The bone support and/orbarrier device disc90 can thus provide a barrier to restrict flow of the bone filler material through a compromisedendplate22 and into undesired areas.
• An embodiment of the bone support and/orbarrier device disc90 can have an undeployed configuration that can be wrapped about theelongate member14, as shown inFIG. 18. Expansion of theexpandable body17 inside the wrappeddisc90 can cause thedisc90 to unwrap to its deployed configuration, as shown inFIGS. 19 and 20.
• In some embodiments, the bone support and/orbarrier device disc90 can be adapted so that theouter surface31 of thedisc90 can be selectively oriented toward a desired portion of a bone. In certain embodiments, theexpandable body17 can be used to orient thedisc90 into various positions within the bone. For example, the bone support and/orbarrier device disc90 can be partially expanded with theexpandable device17 and rotated, or otherwise oriented, such that theouter surface31 of thedisc90 is adjacent a compromisedendplate22 orvertebral body wall23. Theexpandable device17 can then be further expanded to fully deploy the bone support and/orbarrier device disc90. With thedisc90 in place, theexpandable body17 can be deflated and removed. In other embodiments, the bone support and/orbarrier device disc90 can be oriented to a desired position relative to areas within a bony structure in which it has been delivered in other manners and using other apparatus. Once thedisc90 is fully deployed and positioned, thedisc90 can be released from theelongate member14. The void can then be filled with a flowable bone filler material through thedelivery cannula11. In this way, a user can selectively guide and or control distribution of bone filler material within a bony structure and/or helping prevent leakage of bone filler material from a weakened or compromised area.
• In certain embodiments, the bonebarrier device disc90 can be sized so as to span across substantially all of avertebral body endplate22 when in its deployed configuration. Alternatively, the bonebarrier device disc90 can be sized to span less than substantially all of theendplate22 when fully deployed. In some embodiments, a plurality of the bonebarrier device discs90 can be used together to guide and or control distribution of bone filler material within a bony structure.
• During the process of expanding theexpandable body17 against a compromised bony structure, for example, in a vertebral body compression fracture reduction procedure, theexpandable body17 may exert enough pressure on the bony structure, such as theendplate22, to initiate a fracture or to extend an existing fracture. An embodiment of the bone support and/orbarrier device13 can be expanded with theexpandable body17 against a compromisedendplate22. In this manner, the bonebarrier device disc90 can provide a mechanism by which the distribution of bone filler material injected into the bony structure can be guided and/or controlled. As a result, leakage of the bone cement through the compromisedendplate22 can avoided.
• The present invention may provide a system useful for supporting a bony structure in a human or animal. An embodiment of such asystem10 can comprise thedelivery cannula11 having a hollow lumen that can be percutaneously inserted into an interior of a bone, and anelongate member14 insertable through the lumen of thedelivery cannula11. An implantable bone support and/orbarrier device13 comprising anouter surface31 and aninner surface32 can be releasably attached to thedistal end16 of theelongate member14 in an undeployed configuration. Some embodiments of thesystem10 can further comprise a deployment mechanism that can be inserted through the lumen of thedelivery cannula11 and actuated to deploy the bone support and/orbarrier device13 into a deployed configuration in the interior of the bone. Some embodiments of thesystem10 can further comprise a release mechanism adapted to release the bone support and/orbarrier device13 from theelongate member14.
• In such an embodiment of asystem10, in the deployed configuration, at least a first portion of the bone support and/orbarrier device13 can contact a first portion of the bone, such as avertebral body endplate22. A second portion of the bone support and/orbarrier device13 can contact a second portion of the bone, such asvertebral body walls23. In this manner, theaxial load34 placed on the first bone portion can be transferred through thedevice13 to the second bone portion, thereby supporting the first bone portion.
• In some embodiments of abone support system10, the deployment mechanism can comprise theexpandable body17 adapted to be disposed inside the bone support and/orbarrier device13 and to expand thedevice13 into the deployed configuration. In certain embodiments, the deployment mechanism can include a sheath (not shown) covering thedevice13 in the undeployed configuration such that the sheath can be removed to uncover thedevice13 for deployment into the deployed configuration.
• In some embodiments of asystem10, the bone support and/orbarrier device13 can have abarrier material37 attached to thedevice13. Thebarrier material37 can be adapted to prohibit substantially all flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. In this manner, thedevice13 can help prevent leakage of bone filler material through a compromised bony structure adjacent thebarrier material37. Alternatively, thebarrier material37 can comprise an open weave, mesh, and/or through hole pattern adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. In some embodiments, thebarrier material37 can have a porosity sufficient to allow nutrients to diffuse through thebarrier material37.
• Some embodiments of thebone support system10 can include a radiopaque marking pattern in communication with components of thesystem10. For example, a radiopaque marking pattern can be in communication with thedelivery cannula11, theelongate member14, the bone support and/orbarrier device13, and/or other components of thesystem10. Components having a radiopaque marking pattern can be monitored fluoroscopically during and after placement into an interior body region so as to guide the component(s) into desired position(s).
• Some embodiments of thebone support system10 can include a plurality of the bone support and/orbarrier devices13. Each of thedevices13 can be positioned in the deployed configuration to support a separate portion of a bone.
• The present invention can include embodiments of a kit useful for supporting a bony structure in a human or animal. An embodiment of such a kit can comprise thedelivery cannula11 having a hollow lumen that can be percutaneously inserted into an interior of a bone, and anelongate member14 insertable through the lumen of thedelivery cannula11. The kit may further include an implantable bone support and/orbarrier device13 comprising anouter surface31 and aninner surface32 that can be releasably attached to thedistal end16 of theelongate member14 in an undeployed configuration.
• In such an embodiment of thesystem10, in the deployed configuration, at least a first portion of the bone support and/orbarrier device13 can contact a first portion of the bone, such as avertebral body endplate22. A second portion of the bone support and/orbarrier device13 can contact a second portion of the bone, such asvertebral body walls23. In this manner, theload34 placed on the first bone portion can be transferred through thedevice13 to the second bone portion, thereby supporting the first bone portion.
• Some embodiments of the kit can further comprise a deployment mechanism that can be inserted through the lumen of thedelivery cannula11 and actuated to deploy the bone support and/orbarrier device13 into a deployed configuration in the interior of the bone. In some embodiments, the deployment mechanism can comprise theexpandable body17 adapted to be disposed inside thebone support device13 and to expand thedevice13 into the deployed configuration. In certain embodiments, the deployment mechanism can include a sheath (not shown) covering thedevice13 in the undeployed configuration such that the sheath can be removed to uncover thedevice13 for deployment into the deployed configuration. Some embodiments of a kit can further comprise a release mechanism adapted to release the bone support and/orbarrier device13 from theelongate member14.
• In some embodiments of a kit, the bone support and/orbarrier device13 can have abarrier material37 attached to thedevice13. In other embodiments, the bone support and/orbarrier device13 can comprise thebarrier material37 without any other structural support elements. Thebarrier material37 can be adapted to prohibit substantially all flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. In this manner, thedevice13 can help prevent leakage of bone filler material through a compromised bony structure adjacent thebarrier material37. Alternatively, thebarrier material37 can comprise an open weave, mesh, and/or through hole pattern adapted to reduce, but not necessarily stop, the flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. In some embodiments, thebarrier material37 can have a porosity sufficient to allow nutrients to diffuse through thebarrier material37.
• Some embodiments of a kit can include a radiopaque marking pattern in communication with components of the kit. For example, a radiopaque marking pattern can be in communication with thedelivery cannula11, theelongate member14, the bone support and/orbarrier device13, and/or other components of the kit. Components having a radiopaque marking pattern can be monitored fluoroscopically during and after placement into an interior body region so as to guide the component(s) into desired position(s).
• Some embodiments of a bone support kit can include a plurality of the bone support and/orbarrier devices13. Each of thedevices13 can be positioned in the deployed configuration to support a separate portion of a bone.
• In some embodiments, a kit can comprise various combinations of these and/or other components. For example, the kit may further include additional surgical instruments.
• The present invention can include embodiments of methods for supporting a bone or bony structure in a human or animal. One embodiment of a such amethod100, as illustrated inFIG. 21, can include percutaneously inserting (101) thedelivery cannula11 having a hollow lumen into the interior of a bone. An embodiment of themethod100 can include providing (102) an implantable bone support and/orbarrier device13 comprising anouter surface31 and aninner surface32. Thebone support device13 can be releasably attached to thedistal end16 of theelongate member14 in an undeployed configuration. Theelongate member14 and attached bone support and/orbarrier device13 can be inserted (103) through the lumen of thedelivery cannula11 into the interior of the bone.
• Once inside the bone, the bone support and/orbarrier device13 can be positioned (104) in a desired location and/or orientation in the bone. A deployment mechanism can be actuated (105) to deploy the bone support and/orbarrier device13 into a deployed configuration. In some embodiment, in the deployed configuration, a first portion of the device can contact (106) at least a first portion of the bone from the interior of the bone, and a second portion of the device can contact (107) at least a second portion of the bone. In this manner, theload34 placed on the first portion of the bone can be transferred (110) through thedevice13 to the second portion of the bone, thereby providing support to the first bone portion. The bone support and/orbarrier device13 can be released (108) from theelongate member14, and theelongate member14 can be removed (109) from the bone. In some embodiments, a bone filler material can be inserted (111) adjacent thedevice13 to provide support to the bone.
• In other embodiments of themethod100, the bone support and/orbarrier device13 may be percutaneously delivered to a target surgical site using a variety of techniques. For example, a small insertion cannula (not shown) having a sharp tip, for example, a trocar cannula, can be used to penetrate tissue to the surgical site. A guide wire (not shown) may be inserted through the insertion cannula. The insertion cannula can be removed, leaving the guide wire in place. Theelongate member14 and attached bone support and/orbarrier device13 can then be guided over the guide wire to the surgical site. When the bone support and/orbarrier device13 is in a desired position, the guide wire can be removed from theelongate member14.
• In some embodiments of themethod100, a plurality of the bone support and/orbarrier devices13 can be provided. Each of the plurality of thedevices13 can be deployed in a bone to support a separate portion of the bone.
• In some embodiments of themethod100, the deployment mechanism can comprise theexpandable body17. Theexpandable body17, for example, a balloon bone tamp, can be expanded to, for example, moveendplates22 so as restore height to thevertebral body21. The deployment mechanism can be actuated so as to expand theexpandable body17 inside the bone support and/orbarrier device13 to expand thedevice13 into its deployed configuration. In some embodiments, the deployment mechanism can further include a sheath covering thedevice13 in the undeployed configuration. The sheath can be removed to uncover thedevice13 for deployment into its deployed configuration.
• In some embodiments of themethod100, the bone support and/orbarrier device13 can include abarrier material37 attached to thedevice13. Thebarrier material37 can be adapted to prohibit substantially all flow of bone filler material from theinner surface32 to theouter surface31 of thedevice13. When a bone filler material is inserted adjacent theinner surface32 of thebarrier material37 of the bone support and/orbarrier device13, the bone filler material can be prevented from leaking outside an adjacent bony structure.
• In an embodiment of themethod100, thebone support device13 can include acentral rod40 pivotably attached about apivot43 to thedistal end16 of theelongate member14, as shown inFIGS. 4-6. A plurality ofsupport members41 can be pivotably attached to thedistal end42 of thecentral rod40 such that thesupport members41 can be extended outwardly from thecentral rod40. In such a method, actuating (105) the deployment mechanism can further include actuating thefirst mechanism51 to pivot thecentral rod40 to an approximately 90 degree angle relative to alongitudinal axis52 of theelongate member14. Thesecond mechanism53 can then be actuated to extend thesupport members41 outwardly from thecentral rod40 in a circular pattern. In this way, at least a portion of theouter surface31 of the outwardly extendingsupport members41 can contact (106) a first portion of the bone from the bone interior, and the distal ends45 of the outwardly extendingsupport members41 can contact (107) a second portion of the bone so as to provide support to the first bone portion.
• The devices, systems, kits, and methods embodying the present invention can be adapted for use in many suitable interior body regions in humans and animals, wherever it may be desirable to provide support for a tissue. The illustrative embodiments are described in association with devices, systems, kits, and methods used to support bony structures. For example, the device can be utilized to provide structural support in a vertebral body of a spine or in a joint. In other embodiments, the present invention may be used in other interior body regions or types of tissue.
• As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a support member” is intended to mean a single support member or a combination of support members. For the purposes of this specification and the appended claims, unless otherwise indicated, all numbers expressing quantities, conditions, and so forth used in the specification are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification are approximations that can vary depending upon the desired properties sought to be obtained by embodiments of the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
• Notwithstanding that the numerical ranges and parameters setting forth the broad scope of embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges subsumed therein. For example, a stated range of “1 to 10” should be considered to include any and all sub-ranges between (and inclusive of) the minimum value of 1 and the maximum value of 10. That is, a stated range of “1 to 10” should be considered to include, for example, all sub-ranges beginning with a minimum value of 1 or more, such as 1 to 6.5, and ending with a maximum value of 10 or less, such as 5.5 to 10. Additionally, any reference referred to as being “incorporated herein” is to be understood as being incorporated in its entirety.
• Although the present invention has been described with reference to particular embodiments, it should be recognized that these embodiments are merely illustrative of the principles of the present invention. Those of ordinary skill in the art will appreciate that a bone support device, system, kit, and method according to the present invention may be constructed and implemented in other ways and embodiments. In addition, where methods and steps described above indicate certain events occurring in a particular order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Accordingly, the description herein should not be read as limiting the present invention, as other embodiments also fall within the scope of the present invention.

Claims (37)

1. A device, comprising:

a structure implantable in a bone and having an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion, at least a portion of the outer surface comprising the first bone contact portion,

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 the first bone contact portion contacts at least the 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, and

wherein a load on the first portion of the bone is transferred through the structure to the second portion of the bone.

2. The device ofclaim 1, 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.

3. The device ofclaim 1, 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.

4. The device ofclaim 1, further comprising a barrier material attached to the structure adapted to prohibit substantially all flow of bone filler material from the inner surface to the outer surface of the structure.

5. The device ofclaim 1, wherein the implantable structure further comprises:

a central rod; and

a plurality of support members extendable outwardly from an end of the central rod in a circular pattern.

6. The device ofclaim 5,

wherein the deployed configuration further comprises the plurality of support members extending outwardly in a dome shape,

wherein at least a portion of an outer surface of the outwardly extending support members comprises the first bone contact portion, and

wherein distal ends of the outwardly extending support members comprise the second bone contact portion.

7. The device ofclaim 5, further comprising an elongate member having a proximal end and a distal end,

wherein the central rod is pivotably attached to the distal end of the elongate member and a handle is attached to the proximal end of the elongate member, and

wherein the handle comprises a first mechanism adapted to pivot the central rod to an approximately 90 degree angle relative to a longitudinal axis of the elongate member and a second mechanism adapted to extend the support members outwardly from the central rod.

8. The device ofclaim 7, further comprising a release mechanism adapted to release the central rod from the elongate member.

9. The device ofclaim 5, the implantable structure further comprising at least two sets of the plurality of support members, each set of support members capable of being deployed in a different direction in the interior of the bone.

10. The device ofclaim 1, wherein the implantable structure further comprises a frame comprising an outer ring and a plurality of cross-members, each cross-member extending across the outer ring, and wherein the plurality of cross-members comprises the first bone contact portion and the outer ring comprises the second bone contact portion.

11. The device ofclaim 10, wherein the deployed configuration further comprises a dome shape, and wherein the outer surface comprises a convex surface and the inner surface comprises a concave surface.

12. The device ofclaim 10, wherein the deployed configuration further comprises an essentially flat shape.

13. The device ofclaim 10, wherein the cross-members are aligned in a substantially parallel relationship, the undeployed configuration further comprising the outer ring and cross-members collapsed into an elongated configuration.

14. The device ofclaim 10, each cross-member pivotably intersecting with another cross-member, wherein the undeployed configuration comprises the cross-members collapsed about the intersections to a nearly parallel relationship, and wherein a force exerted against an end of the collapsed cross-members moves the device into a deployed configuration.

15. 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 support device comprising an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion, 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 support 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.

16. The system ofclaim 15,

wherein in the deployed configuration 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, and

wherein a load placed on the first portion of the bone is transferred through the device to the second portion of the bone.

17. The system ofclaim 15, further comprising a barrier material attached to the bone support device adapted to prohibit substantially all flow of bone filler material from the inner surface to the outer surface of the device.

18. The system ofclaim 15, 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.

19. The system ofclaim 15, 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.

20. The system ofclaim 15, further comprising a radiopaque marking pattern in communication with at least one of the delivery cannula, the elongate member, and the bone support device.

21. The system ofclaim 15, further comprising a plurality of the bone support devices, each of the devices positionable in the deployed configuration to support a separate portion of the bone.

22. 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 support device comprising an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion, the device releasably attachable to a distal end of the elongate member in an undeployed configuration.

23. The kit ofclaim 22,

wherein in the deployed configuration the first bone contact portion contacts at least the 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, and

wherein a load placed on the first portion of the bone is transferred through the device to the second portion of the bone.

24. The kit ofclaim 22, further comprising a barrier material attached to the bone support device adapted to prohibit substantially all flow of bone filler material from the inner surface to the outer surface of the device.

25. The kit ofclaim 22, further comprising a deployment mechanism insertable through the lumen of the delivery cannula and actuatable to deploy the bone support device into a deployed configuration in the interior of the bone.

26. The kit ofclaim 24, further comprising a release mechanism adapted to release the bone support device from the elongate member.

27. The kit ofclaim 22, further comprising a plurality of the bone support devices, each of the devices positionable in the deployed configuration to support a separate portion of the bone.

28. A method, comprising:

providing an implantable bone support device comprising an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion, the device releasably attached in an undeployed configuration to a distal end of an elongate member;

percutaneously inserting the elongate member and attached bone support device into an interior of a bone;

deploying the bone support device into a deployed configuration;

contacting at least a first portion of the bone with the first bone contact portion;

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;

releasing the bone support device from the elongate member; and

removing the elongate member from the bone.

29. The method ofclaim 28, 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.

30. The method ofclaim 28, 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.

31. The method ofclaim 29, further comprising inserting an expandable body into the bone interior, and expanding the expandable body to restore height to the vertebral body.

32. The method ofclaim 28, further comprising injecting a bone filler material adjacent the inner surface of the bone support device.

33. The method ofclaim 28, wherein the bone support device further comprises a barrier material attached to the device and adapted to prohibit substantially all flow of bone filler material from the inner surface to the outer surface of the device.

34. The method ofclaim 28, wherein deploying the bone support device further comprises expanding the expandable body inside the bone support device.

35. The method ofclaim 28,

wherein the bone support device further comprises a sheath covering the device in the undeployed configuration, and

wherein deploying the bone support device further comprises removing the sheath from the bone support device.

36. The method ofclaim 28, the bone support device further comprising a central rod and a plurality of support members pivotably attached to an end of the central rod, wherein deploying the bone support device further comprises:

actuating a first mechanism to pivot the central rod to an approximately 90 degree angle relative to a longitudinal axis of the elongate member; and

actuating a second mechanism to extend the support members outwardly from the central rod in a circular pattern,

wherein at least a portion of an outer surface of the outwardly extending support members comprises the first bone contact portion, and

wherein distal ends of the outwardly extending support members comprise the second bone contact portion.

37. The method ofclaim 28, further comprising providing a plurality of the bone support devices, and deploying each of the plurality of the devices to support a separate portion of the bone.

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