EP1804733A1

EP1804733A1 - Expandable support devices and methods of use

Info

Publication number: EP1804733A1
Application number: EP05799664A
Authority: EP
Inventors: E. Skott Greenhalgh; John Paul Romano; Michael P. Igoe
Original assignee: Secant Medical LLC; Stout Medical Group LP
Current assignee: Stout Medical Group LP
Priority date: 2004-09-24
Filing date: 2005-09-26
Publication date: 2007-07-11
Also published as: EP1804733A4; WO2006037013A1

Abstract

An expandable support device for tissue repair is disclosed. The device can be used to repair hard or soft tissue, such as bone or vertebral discs. A method of repairing tissue is also disclosed. A slidable expansion device is disclosed. The expansion device can have an expansion component, a deployment extension, and a handle. The expansion component can have multiple elements. When at least two elements slide with respect to each other, the expansion device can expand. Methods of using the device are also disclosed.

Description

TITLE OF THE INVENTION EXPANDABLE SUPPORT DEVICES AND METHODS OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Application No. 60/612,723, filed 24 September 2004, and U.S. Application No. 60/612,724, filed 24 September 2004, each of which is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION [0002] This invention relates to devices for remotely creating a force, such as for deploying medical devices, and providing support for biological tissue, for example to repair spinal compression fractures, and methods of using the same. [0003] Vertebroplasty is an image-guided, minimally invasive, nonsurgical therapy used to strengthen a broken vertebra that has been weakened by disease, such as osteoporosis or cancer. Vertebroplasty is often used to treat compression fractures, such as those caused by osteoporosis, cancer, or stress. [0004] Vertebroplasty is often performed on patients too elderly or frail to tolerate open spinal surgery, or with bones too weak for surgical spinal repair. Patients with vertebral damage due to a malignant tumor may sometimes benefit from vertebroplasty. The procedure can also be used in younger patients whose osteoporosis is caused by long-term steroid treatment or a metabolic disorder. [0005] Vertebroplasty can increase the patient's functional abilities, allow a return to the previous level of activity, and prevent further vertebral collapse. Vertebroplasty attempts to also alleviate the pain caused by a compression fracture. [0006] Vertebroplasty is often accomplished by injecting an orthopedic cement mixture through a needle into the fractured bone. The cement mixture can leak from the bone, potentially entering a dangerous location such as the spinal canal. The cement mixture, which is naturally viscous, is difficult to inject through small diameter needles, and thus many practitioners choose to "thin out" the cement mixture to improve cement injection, which ultimately exacerbates the leakage problems. The flow of the cement liquid also naturally follows the path of least resistance once it enters the bone - naturally along the cracks formed during the compression fracture. This further exacerbates the leakage. [0007] The mixture also fills or substantially fills the cavity of the compression fracture and is limited to certain chemical composition, thereby limiting the amount of otherwise beneficial compounds that can be added to the fracture zone to improve healing. Further, a balloon must first be inserted in the compression fracture and the vertebra must be expanded before the cement is injected into the newly formed space. [0008] A vertebroplasty device and method that eliminates or reduces the risks and complexity of the existing art is desired. A vertebroplasty device and method that is not primarily based on injecting a liquid directly into the compression, fracture zone is desired.

BRIEF SUMMARY OF THE INVENTION [0009] An expansion device for use in surgical procedures is disclosed. The expansion device has an expansion component. The expansion component b.as a first slidable element and a second slidable element. The first slidable element is slideably attached to the second slidable element. Sliding the first slidable element against the second slidable element expands the expansion component. [0010] The device can have a deployment extension. The deployment extension can have a first arm. The first arm can be fixedly attached to the first slidable element. The deployment extension can have a second arm. The second arm can be fixedly attached to the second slidable element. The device can have a handle. The first arm can be fixed to the first slidable element, and the first arm can be fixed to the handle. The second, arm can be fixed to the second slidable element, and the second arm can be slidably attached to the handle. [0011] A method for deploying an expandable device to a target site within a biological subject is also disclosed. The method includes loading the expandable device on an expansion device. The expansion device has a first slidable element and a second slidable element. The method also includes locating the expandable device at the target site. The method further includes expanding the expansion device. Expanding the expansion device includes sliding the first slidable element relative to the second slidable element.

BRIEF DESCRIPTION OF THE DRAWINGS [0012] Figures 1 through 3 are side perspective views of various embodiments of the expandable support device. [0013] Figures 4 through 6 illustrate various embodiments of cross-section A-A of the expandable support device. [0014] Figure 7 through 13 are side perspective views of various embodiments of^" the expandable support device. [0015] Figure 14 is a side perspective view of an embodiment of the expandable support device in an expanded configuration. [0016] Figure 15 is an end view of an embodiment of the expandable support device. [0017] Figure 16 is a side perspective view of the embodiment of the expandable support device of Figure 14 in a contracted configuration. [0018] Figures 17 through 19 illustrate an embodiment of a method of deploying multiple expandable support devices. [0019] Figure 20 is a schematic figure of an embodiment of the expandable support device in a contracted configuration. [0020] Figure 21 is a schematic figure of an embodiment of the expandable support device of Figure 20 in an expanded configuration. [0021] Figure 22 illustrates an embodiment of the slidable expansion device. [0022] Figure 23 illustrates an embodiment of a method for loading the expandable support device of Figure 12 onto the slidable expansion device of Figure 22. [0023] Figures 24 and 25 illustrate an embodiment of a method for using the slidable expansion device. [0024] Figure 26 illustrates an embodiment of a method for using the slidable expansion device. [0025] Figure 27 illustrates an embodiment of a method for using the slidable expansion device. [0026] Figures 28 and 29 show side and front views, respectively, of an embodiment of the expansion component. [0027] Figures 30 and 31 show side and front views, respectively, of an embodiment of a method for using the embodiment of the expansion component of Figures 28 and 29. [0028] Figures 32 and 33 show side and front views, respectively, of an embodiment of the expansion component. [0029] Figures 34 and 35 show side and front views, respectively, of an embodiment of a method for using the embodiment of the expansion component of Figures 32 and 33. [0030] Figures 36 and 37 show side and front views, respectively, of an embodiment of the expansion component. [0031] Figures 38 and 39 show side and front views, respectively, of an embodiment of a method for using the embodiment of the expansion component of Figures 36 and 37. [0032] Figures 40 and 41 show side and front views, respectively, of an embodiment of the expansion component. [0033] Figures 42 and 43 show side and front views, respectively, of an embodiment of a method for using the embodiment of the expansion component of Figures 40 and 41. [0034] Figures 44 and 45 show side and front views, respectively, of an embodiment of the expansion component. [0035] Figures 46 and 47 show side and front views, respectively, of an embodiment of a method for using the embodiment of the expansion component of Figures 44 and 45. [0036] Figures 48 and 49 illustrate an embodiment of the expansion component and an embodiment of a method for using the expansion component. [0037] Figures 50 through 52 illustrate an embodiment of a method for deploying the expandable support device. [0038] Figures 53 through 55 illustrate an embodiment of a method for deploying the expandable support device. [0039] Figure 56 illustrates various methods for using the slidable expansion device. [0040] Figures 57 through 59 illustrate various methods for using the expandable support device. [0041] Figures 60 through 62 illustrate an embodiment of a method for using the slidable expansion device. DETAILED DESCRIPTION [0042] U.S. Provisional Patent Application No. 60/612,001, titled "EXPANDABLE SUPPORT DEVICE AND METHOD OF USE", filed on 21 September 2004 is herein incorporated by reference in its entirety, and herein referred to as the POOl Patent Application. U.S. Provisional Patent Application No. 60/611 ,972, titled "BALLOON AND METHODS OF MAKING AND USING", filed on 21 September 2004 is herein incorporated by reference in its entirety, and herein referred to as the P005 Patent Application. [0043] Figure 1 illustrates an expandable support device 2, such as a stent, that can be implanted in a bone, such as a compression fracture in a vertebra, or in soft tissue, such as a herniated intervertebral disc. The expandable support device 2 can be biocompatible. The expandable support device 2 can have any configurations, and be used for methods, described in the POOl Patent Application. The expandable support device 2 can have a first end 4 and a second end 6. [0044] Figure 2 illustrates that the expandable support device 2 can have a wall 8. The wall 8 can have struts 10. The struts 10 can vary in density along the length of the expandable support device 2 from the first end 4 to the second end 6. The density of the struts 10 can be higher near the first end 4 than near the second end 6 (as shown). The density of the struts 10 can be higher near the second end 6 than near the first end 4. The density of the struts 10 can be higher near the first end 4 and the second end 6 than the middle between the first 4 and second ends 6. [0045] Figure 3 illustrates that the expandable support device 2 can have a tapered configuration before or after deployment. The first end 4 can have a first diameter 12. The second end 6 can have a second diameter 14. The second diameter 14 can be greater than the first diameter 12 (as shown). The first diameter 12 can be greater than the second diameter 14. The first 12 and second diameters 14 can be greater than a diameter in the middle of the expandable support device 2 between the first 4 and second ends 6. The tapered configuration can be a result of a greater strength of the expandable support device 2 at or near the tapered section or end of the expandable support device 2. A greater density of struts 10 can be at the first end 4. The struts 10 at the first end 4 can have a greater strut diameter 24 than the struts 10 at the second end 6. The expandable support device 2 can have a first port 16 at the first end 4. The expandable support device 2 can have a second port 18 at the second end 6. [0046] Figure 4 illustrates in cross-section A-A 20 can have a varying wall thickness 22 along a longitudinal length of the expandable support device 2 from the first end 4 to the second end 6. The wall thickness 22 can be greater at the first 4 and second ends 6 than in the middle of the expandable support device 2 between the first 4 and second ends 6. [0047] Figure 5 illustrates that the wall 8 can be made from struts 10. The strut diameters 24 can vary along the length of the expandable support device 2. Figure 5 illustrates the strut diameters 24 can be greater at the first 4 and second ends 6 than the strut diameters 24 between the first 4 and second ends 6. Figure 6 illustrates that the strut diameters 24 can be greater at the second end 6 than the strut diameters 24 at the first end 4. The strength of the wall 8 can be adjusted along the length of the expandable support device 2 by designing varying, for example, strut diameters 24, strut cross-sectional areas, strut densities (i.e., strut spacing, number of struts), strut cross-sectional geometries, and combinations thereof. [0048] Figure 7 illustrates that the expandable support device 2 can have a bullet shape. The wall 8 can have a first radius of curvature 26 near or at the first end 4. The first end 4 can have a first rim 30 circumferentially around the first end 4. The wall 8 can have a second radius of curvature 28 near or at the second end 6. The first radius of curvature 26 can be less than the second radius of curvature 28 (as shown). The first radius of curvature 26 can be greater than the second radius of curvature 28. The first and second radii of curvature can be greater than a radius of curvature between the first 4 and second ends 6. [0049] Figure 8 illustrates that the expandable support device 2 can be sharply pointed at the first 4 (as shown), and/or second ends 6. The first end 4 can have a smaller first port 16 than the second port 18, or no first port 16 (as shown). The first end 4 can be made from, for example, a plastic and/or dense mesh of thick wires. [0050] Figure 9 illustrates an expandable support device 2 having a first port 16 and/or a second port 18 smaller than the diameter of the expandable support device 2. A hollow 32 of the expandable support device 2 can have agents and/or a matrix as listed below. [0051] Figure 10 illustrates an expandable support device 2 having a first port 16 at the first end 4 and no port at the second end 6. The wall 8 can cover the first 4 and/or second ends 6. [0052] Figure 11 illustrates that the expandable support device 2 can have a thread 34. The expandable support device 2 can be rotated during implantation to screw into an implant site, such as a vertebra 194. [0053] Figure 12 illustrates an expandable support device 2 that can have an engagement groove 36. The engagement groove 36 can be on the inner diameter of the expandable support device 2. The engagement groove 36 can be configured to engage the external engagement thread on the expansion component 90. The expandable support device 2 can be or have any characteristics or features disclosed in the POOl Patent Application. [0054] Figure 13 illustrates an expandable support device 2 that can be made from a resilient or deformable rolled sheet. The sheet can be unrolled, as shown by arrows, to expand 38. [0055] Figure 14 illustrates an expandable support device 2 having a coil. The coil can have an expanded diameter 40. The coil can have a first tip 42 at the first end 4. The coil can have second tip 44 at the second end 6. [0056] Figure 15 illustrates that the expandable support device 2, such as the device shown in Figure 14, can be untwisted 46 to contract the expandable support device 2. The first 42 and/or second tip 44 can be fixed during untwisting 46. The expandable support device 2 can be contracted and loaded onto a deployment device for deployment during surgery. [0057] Figure 16 illustrates the expandable support device 2 in an untwisted configuration. The untwisted expandable support device 2 can have a contracted diameter 48. The contracted diameter 48 can be less than the expanded diameter 40. The coils can be resiliently or deformably altered in configuration during untwisting. The coils can resiliently expand when released from the untwisted configuration. [0058] Figure 17 illustrates that multiple expandable support devices 2 can each have an outer diameter and an inner diameter. The first expandable support device can have a first device outer diameter that can be equal to or greater, for example by a substantially small amount, than a second device inner diameter. The second expandable support device can have a second device outer diameter that can be equal to or greater, for example by a substantially small amount, than a third device inner diameter. The first device can have a first device inner diameter 72 and the third device can have a third device outer diameter 74. [0059] As shown in Figures 17 and 18, the third expandable support device can be deployed. The second expandable support device can then be inserted into the third expandable support device. The second expandable support device can then be expanded in the third expandable support device. [0060] As shown in Figures 17 and 19, the first expandable support device can then be inserted into the second expandable support device. The first expandable support device can then be expanded into the second expandable support device. The concentrically smaller expandable support devices 2 can butt against the next larger expandable support devices 2 (the gap shown in Figure 19 between the third and second expandable support devices 2 is for illustrative purposes). Each expandable support device can support, and/or substantially lock into place, the next larger, abutting, expandable support device. [0061] Figures 20 and 21 illustrate an expandable support device 2 that can have a first wedge 76 and a second wedge 78, such as the buttress of Figures 61 through 63 of the POOl Patent Application, of which any characteristic, feature, or functionality can be used for the expandable support device 2 described herein. A first wedge force 80 can be applied to the first wedge 76. A second wedge force 82 can be applied to the second wedge 78. The first wedge can translate 84, as shown by arrow. The second wedge can translate 86, as shown by arrow. Figure 21 illustrates that the expandable support device 2 can have a larger, expanded diameter 40 after the first 80 and second wedge forces 82 have been, applied. [0062] Figure 22 illustrates a slidable expansion device 88. The slidable expansion device 88 can have an expansion component 90, a deployment extension 92, a handle 94, or combinations thereof. The expansion component 90 can be configured to radially and/or longitudinally expand. The expansion component 90 can expand directly against tissue and/or expand an implant pre-loaded into the deployment site, and/or loaded onto or into the expansion component 90. [0063] The expansion component 90 can have a first slidable element 96 and a second slidable element. The first and second slidable elements 96 and 98 can be configured to slide relative to each other. An interface 100 can be between the first slidable element 96 and the second slidable element 98. The expansion component 90 can have an engagement element, such as an external engagement thread. The external engagement thread can spiral around the expansion component 90. The interface 100 can intersect the external engagement thread 102. [0064] The deployment extension 92 can have a first extension arm 104 and a second extension arm 106. The first extension arm 104 can be fixedly attached to a third fixed element, such as the handle 94. The first extension arm 104 can be fixedly attached to the expansion component 90. The first extension arm 104 can maintain a substantially constant distance between the handle 94 and the first slidable element 96. The second extension arm 106 can be fixedly attached to the slidable expansion device 88 and slidably attached to the third fixed element, such as the handle 94. [0065] The angle between, an extension arm longitudinal axis 108, such as an axis extending along the second extension arm 106, and the interface 100 can form an expansion angle 110. The expansion angle 110 can be from about 0° to about 85°, more narrowly from about 10° to about 45°, for example about 30°. [0066] The handle 94 can have an activation system configured to expand the expansion component 90. For example, the handle 94 can have a lever 112 than can be fixedly or rotatably attached to the second extension arm 106. The lever 112 can be rotatably attached to a lever pivot 1 14. The lever pivot 114 can be fixedly attached to a case of the handle 94. A return spring 116 can be attached to the lever 112. The return spring 116 can apply a force against the lever 112 sufficient to keep the lever 112 against a first stop 118 when the slidable expansion device 88 is not in use. [0067] Figure 23 illustrates that the expandable support device 2 can be loaded onto the expansion component 90 of the slidable expansion device 88. The expandable support device 2 can be translated, as shown by arrow 120, to the expansion component 90. The engagement groove 36 can be aligned with the external engagement thread, and the expandable support device 2 can be rotated, as shown by arrows 122, for example, to engage and load onto the expansion component 90. [0068] Figure 24 illustrates that, when loaded on the slidable expansion device 88, the expandable support device 2 (shown in see-through without details) can have an expandable support device diameter 124. [0069] Figure 25 illustrates that the lever 1 12 can be forced to retractably rotate, as shown by arrow 126, the second extension arm 106. The movement of the lever 112 can compress the return spring 116. The rotation of the lever 112 can be limited by physical interference at the second stop 128. The translation of the second extension arm 130 can, in turn, translate, as shown by arrow 132 the second slidable element 98. As the second slidable element 98 translates along the interface 100, the second slidable element 98 can shift downward (with respect to the page) and the first slidable element 96 can shift upward, thereby causing expansion, as shown by arrows 134, of the expansion component 90 and the expandable support device 2. Tlie expandable support device diameter 124 can be larger after expansion than before expansion. The first extension arm 104 and/or the second extension arm 106 can resiliently and/or deformably flex during expansion of the expansion component 90. [0070] Figure 26 illustrates that the first and/or second slidable element 96 and/or 98 can have no external engagement thread. The first and/or second slidable element 96 and/or 98 can be coated or lubricated with a low-friction material, such as TEFLON® (i.e., PTFE) from E. I. Du Pont de Nemours and Company, Wilmington, DE. [0071] Figure 27 illustrates that the force can be removed from the lever 112. The return spring 116 can translate, as shown by arrow 136. The lever 112 can be rotated, as shown by arrow 138, by the return spring 116. The first stop 118 can limit the rotation of the lever 112. The second extension arm 106 can translate, as slxown by arrow 140, the second slidable element 98. The expansion component 90 can return to a contracted configuration. The expansion component 90 can be removed from the then-expanded expandable support device 2. [0072] Figures 28 and 29 illustrate that the expansion component 90 can have a substantially triangular, or wedge-shaped first and second slidable elements 96 and 98. Figures 30 and 31 illustrate that a first slidable element force, shown by arrow 142, can be applied to the first slidable element 96 in substantially the opposite direction as a second slidable element force, shown by arrow 144, can be applied to the second slidable element 98. The first slidable element 96 and the second slidable element 98 can translate, as shown by arrows 146 and 140, in opposite directions with respect to each other parallel to the interface 100. [0073] Figures 32 and 33 illustrate that the expansion component 90 can have . substantially triangular or wedge-shaped first and second slidable elements 96 and 98. The expansion component 90 can have multiple first slidable elements 96 and multiple interfaces 100. Figures 34 and 35 illustrate that a first slidable element force, shown by arrow 142, can be applied to the first slidable elements 96 iα substantially the opposite direction as a second slidable element force, shown by arrow 144, can be applied to the second slidable element 98. The first slidable elements 96 and the second slidable element 98 can translate, as shown by arrows 146 and 140. [0074] Figures 36 and 37 illustrate that the expansion component 90 can ha."ve a first slidable element 96 that can be flexibly resilient or deformbly and can have a conical port therein. The second slidable element 98 can be substantially conical and can be positioned in the conical port of the first slidable element 96. Figures 38 and 39 illustrate that a first slidable element force, shown by arrow 142, can be applied to trie first slidable element 96 in substantially the opposite direction as a second slidable element force, shown by arrow 144 can be applied to the second slidable element 98. The first slidable element 96 can translate, as shown by arrows 146. The first slidable element 96 can resiliently or deformably expand radially outward. [0075] Figures 40 and 41 illustrate that the expansion component 90 can have multiple first slidable elements 96 that can be flexibly resilient or deformbly and can. have a conical port therein. The first slidable elements 96 can be segmented or separated by element separations 148. The element separations 148 can be thinned and very low resistant or completely severed areas or lines (as shown). The second slidal>le element 98 can be substantially conical and can be positioned in the conical port of the first slidable element 96. Figures 42 and 43 illustrate that first slidable element forces, shown by arrow 142, can be applied to the first slidable elements 96 in substantially tiie opposite direction as a second slidable element force, shown by arrow 144, can be applied to the second slidable element 98. The first slidable elements 96 can translate, as shown by arrows 146. The first slidable elements 96 can resiliently or deformably exipand radially outward. The first slidable elements 96 can be attached by a filament or thin strip of material (not shown), or can be distinct and unattached to each other. [0076] Figures 44 and 45 illustrate that the expansion component 90 can have a first slidable element 96 that can be rotatably attached to a second slidable element 98 via a hinge 150. The hinge 150 can rotate about a hinge pin 152 that can pass through the first slidable element 96 and the second slidable element 98. The second slidable element 98 can have a cam 154. A camshaft 156 can rotatably attach the cam 154 to the second slidable element 98. The cam 154 can be attached to all or part of the deployment extension 92. The cam 154 can be located in a depression or cavity in the second slidable element 98. [0077] Figures 46 and 47 illustrate that the deployment extension 92 can be translated, as shown by arrow 158. This translation can rotate, as shown by arrow 160, the cam 154. The cam 154 can slide along the first slidable element 96 and can cause the first slidable element 96 to rotate, as shown by arrow 162, about the hinge pin 152. [0078] Figure 48 illustrates that the first slidable element 96 can have a slidable element port 164. The slidable element port 164 can be shaped (e.g., grooved or threaded) to receive the second slidable element 98. The second slidable element 98 can be conical. The second siidable element 98 can have a slidable element thread 166. The slidable element port 164 can be threaded. The second slidable element 98 can be translated, as . shown by arrow 140 and rotated, as shown by arrow 168, as the second slidable element 98 approaches the slidable element port 164. [0079] Figure 49 illustrates that the second slidable element 98 can enter the slidable element port 164. The first slidable element 96 can expand, as shown by arrows 170, as the slidable element port 164 receives the second slidable element 98. The slidable element thread can engage the slidable element port 164. The second slidable element 98 can be rotated, as shown by arrows 168, as the second slidable element 98 enters the first . slidable element 96. [0080] The tapered, bulleted, sharp-pointed, or other configuration of the expandable support devices 2 can result from (e.g., be deployed by) expanding the expandable support devices 2 with balloons of similar shapes, examples of which are described in the P005 Patent Application. [0081] The tapered, bulleted and sharp-pointed expandable support devices 2 can be implanted with the smaller or sharper end leading the implantation. The leading end can then be used to help move tissue aside during implantation. The leading end can be self- penetrating. [0082] The ends of the expandable support devices 2 can be laser cut, and/or non-laser cut. The non-laser cut expandable support device 2 ends can have a hoop of material. The hoop can be used to attach a tip, such as a sharp tip and/or a closed tip. The expandable support devices 2 can be segmented. The hoop can attach to another . expandable support device 2. [0083] The expandable support devices 2 can have struts 10 that can kink or bubble open in a way that will increase the force necessary to crush the expandable support devices 2. For example, the struts 10 can form obtuse angles within the strut when deployed. [0084] The expandable support devices 2 can have textured and/or porous surfaces for example, to increase friction against bone surfaces, and/or promote tissue ingrowth. The expandable support devices 2 can be coated with a bone growth factor, such as a calcium base. [0085] The expandable support device 2 can be covered by a thin metal screen. The thin metal screen can expand and/or open when the expandable support device 2 expands. [0086] The expandable support device 2 can open into an oval cross-section. [0087] The expandable support device 2 can be laser cut in a partially opened pattern, ' ■ then the expandable support device 2 can be loaded (e.g., crimped) onto a deployment tool 176 (e.g., balloon). The loaded expandable support device 2 can have a smaller profile while plastically deforming the struts 10 past their limits. [0088] Any or all elements of the expandable support device 2 and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, IL; CONICHROME® from Carpenter Metals Corp., Wyomissing, PA), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, CT), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 October 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET)/polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, DE), polypropylene, (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, MA), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo- polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold. [0089] Any or all elements of the expandable support device 2 and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, DE), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof. [0090] Any or all elements of the expandable support device 2 and/or other devices or apparatuses described herein and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements, fillers, glues, and/or an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors. [0091] Examples of such cements and/or fillers includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof. [0092] The agents within these matrices can include any agent disclosed herein or ■ combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents: cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-I) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, PA; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, NJ; CELEBREX® from Pharmacia Corp., Peapack, NJ; COX-I inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, PA), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostaglandin E₂ Synthesis in Abdominal Aortic Aneurysms, Circulation, July 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu et al, SpI Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties. [0093] Figure 50 illustrates an expandable support device 2 that can be a coil. The expandable support device 2 can have a longitudinal axis. The expandable support device 2 can have a tensioner 174. A first end 4 of the tensioner 174 can be fixedly or removably attached a first end 4 of the expandable support device 2. A second end 6 of the can be fixedly or removably attached a second end 6 of the expandable support device 2. The tensioner 174 can be in a relaxed configuration when the expandable support device 2 is in a relaxed configuration. The tensioner 174 can create a tensile force between the first end 4 of the expandable support device 2 and the second end 6 of the expandable support device 2 when the expandable support device 2 is in a stressed configuration. The tensioner 174 can be, for example, a resilient wire, a coil spring, an elastic member, or combinations thereof. [0094] The expandable support device 2 can have a coil. The coil can have turns of a wire, ribbon, or other coiled element. The coil can be made from a wire, ribbon, or other coiled element having a circular, square, or oval cross-section. The expandable support device 2 can be a series of connected hoops. [0095] Figure 50 illustrates that the expandable support device 2 can be loaded into a hollow deployment tool 176 in a smear 178 (i.e., partially shear stressed) configuration. The expandable support device 2 in the smear 178 configuration can have a relaxed first end 4, a stressed smear 178 section, and a relaxed second end 6. The longitudinal axis 172 can be not straight (i.e., non-linear) through the smear 178 section. [0096] Figure 51 illustrates that part of the expandable support device 2 can be forced, as shown by arrow, out of the deployment tool 176. The second end 6 can exit the deployment tool 176 before the remainder of the expandable support device 2. The smear 178 section can then partially relax. The second end 6 can be positioned to a final location before the remainder of the expandable support device 2 is deployed from the deployment tool 176. [0097] Figure 52 illustrates that the remainder of the expandable support device 2 can be forced, as shown by arrow, out of the deployment tool 176. The smear 178 section can substantially relax. The longitudinal axis 172 can return to a substantially relaxed and/or straight (i.e., linear) configuration. [0098] Figure 53 illustrates that the expandable support device 2 can be loaded into the hollow deployment tool 176 with the longitudinal axis 172 of the expandable support device 2 substantially parallel with the hollow length of the deployment tool 176. The entire length of the expandable support device 2 can be under shear stress. [0099] Figure 54 illustrates that part of the expandable support device 2 can be forced, as shown by arrow, out of the deployment tool 176. The second end 6 of the expandable support device 2 can exit the deployment tool 176 before the remainder of the expandable support device 2. The tensioner 174 can apply a tensile stress between the ends of the expandable support device 2, for example, forcing the deployed second end 6 of the expandable support device 2 to "stand up straight". The second end 6 of the expandable support device 2 can be positioned to a final location before the remainder of the expandable support device 2 is deployed from the deployment tool 176. [0100] Figure 55 illustrates that the remainder of the expandable support device'2 can be forced, as shown by arrow, out of the deployment tool 176. The expandable support device 2 can substantially relax. [0101] Figure 56 illustrates that a deployment extension 92 can enter through the subject's back. The first deployment extension 180 can enter through a first incision 182 in skin 184 on the posterior side of the subject near a vertebral column 186. The first deployment extension 180 can be translated, as shown by arrow 188 to position a first slidable expansion device 190 adjacent or into an intervertebral disc 192 (as shown) or vertebra 194 [0102] A second deployment extension 196 can enter through a second incision 198 (as shown.) in the skin 184 on the posterior or through the first incision 182. The second deployment extension 196 can be translated through muscle (not shown), around nerves 200 and anterior of the vertebral column 186. The second deployment extension 196 can be steerable. The second deployment extension 196 can be steered, as shown by arrow 202, to align the distal tip of a second slidable expansion device 204 with the anterior side of the disc 192 or vertebra 194. The second deployment extension 196 can translate, as shown by arrow 206 to position the second slidable expansion device 204 in the disc 192 or vertebra 194. [0103] The disc 192 or vertebra 194 can have multiple slidable expansion devices 88 deployed therein. The slidable expansion devices 88 can be deployed from the anterior, posterior, both lateral, superior, inferior, any angle, or combinations of the directions thereof. Multiple slidable expansion devices 88 can be deployed sequentially and/or simultaneously. The slidable expansion devices 88 can be used to deploy expandable support devices 2 (not shown in Figure 56). [0104] Figures 57 through 59 illustrate various methods for using the expandable support device 2. Figure 57 illustrates that multiple, for example two 208 and 210, expandable support devices 2 can be implanted into a spine, for example a vertebra (as shown) and/or intervertebral disc 192, in a substantially parallel and/or side-by-side configuration. [0105] Figure 58 illustrates that the expandable support device 2 can be implanted from and/or into a lateral portion of the vertebra 194 (as shown) and/or intervertebral disc 192. Figure 28 illustrates that multiple expandable support devices 2 can be implanted from and/or into anterior and/or lateral portions of the vertebra 194 (as shown) and/or intervertebral disc 192. Curved expandable support devices 2 can also be implanted into the spine, such that the curve can prevent rolling the expandable support device 2 during primary force application, (e.g., implantation as shown in Figure 59 can prevent rolling of the expandable support devices 2 during spinal compression pressure.) [0106] Figure 60 illustrates that the expansion component 90 can be attached to one or more cleats 212. The cleats 212 can extend from the expansion component 90. The cleats 212 can have a surface (e.g., having hooks, barbs, feet) configured to maximize the ability to grip or grab other surfaces. The expansion component 90 can be translated, as shown by arrow, to a target site. [0107] Figure 61 illustrates that the expansion component 90 can be positioned so that the cleats 212 can grip or grab one or more surfaces, such as the surfaces of adjacent vertebrae 194. Figure 62 illustrates that the expansion component 90 can be inflated once the cleats 212 are positioned at a target site, such as in contact with, or adjacent to, the vertebrae 194. The expansion component 90 can expand due to increased internal fluid pressure. The cleats 212 can apply expansion forces, as shown by arrows, to the surrounding bones, such as the vertebrae 194. The expansion component 90 can be deployed between ribs to create sufficient access to the thorax, for example to gain access to the thorax, such as the heart, for surgical procedures. [0108] The expansion component 90 can be used as a support and/or to separate bones, within, outside or between bones. The expansion component 90 can be used to deploy stents, scaffolds, expandable support devices 2, such as those disclosed in the POOl Patent Application. The expansion component 90 can be used to expand devices or anatomical tissues or elements such as compression bone (e.g., vertebral) fractures, soft tissue failures (e.g., herniated intervertebral discs) and methods of deploying disclosed in the POOl Patent Application. [0109] It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements shown with any embodiment are exemplary for the specific embodiment and can be combined and/or used on other embodiments within this disclosure.

Claims

CLAIMS We claim: 1. An expandable support system for performing completely implantable spinal repair, comprising: a first expandable support device having a first longitudinal axis; and a second expandable support device having a second longitudinal axis; wherein the first expandable support device is within the second expandable support device, and wherein the first longitudinal axis is substantially parallel to the second longitudinal axis.

2. The system of Claim 1, wherein the first expandable support device is substantially cylindrical.

3. The system of Claim 2, wherein the second expandable support device is substantially cylindrical.

4. An expandable support device for performing completely implantable spinal repair, having a first longitudinal axis and a wall having a wall thickness; wherein the wall thickness varies along the length of the longitudinal axis.

5. An expandable support device for performing completely implantable spinal repair, having a tapered configuration.

6. An expandable support device for performing completely implantable spinal repair, having a bullet configuration.

7. An expandable support device for performing completely implantable spinal repair, having a first end and a second end, wherein the first end has a port.

8. The device of Claim 7, wherein the second end has a port.

9. An expandable support device for performing completely implantable spinal repair, having a first end and a second end, wherein the first end is closed.

10. The device of Claim 9, wherein the second end is closed.

11. An expandable support device for performing completely implantable spinal repair, wherein the cross-section shape varies along the longitudinal axis.

12. An expansion device for use in surgical procedures comprising: an expansion component comprising a first slidable element and a second slidable element, wherein the first slidable element is slideably attached to the second slidable element, and wherein sliding the first slidable element against the second slidable element expands the expansion component.

13. The device of Claim 12, further comprising a deployment extension.

14. The device of Claim 13, wherein the deployment extension comprises a first arm,

15. The device of Claim 14, and wherein the first arm is fixedly attached to the first slidable element.

16. The device of Claim 14, wherein the deployment extension comprises a second arm.

17. The device of Claim 16, wherein the second arm is fixedly attached to the second slidable element.

18. The device of Claim 17, further comprising a handle.

19. The device of Claim 18, wherein the first arm is fixed to the first slidable element, and wherein the first arm is fixed to the handle.

20. The device of Claim 19, wherein the deployment extension comprises a second arm, and wherein the second arm is fixed to the second slidable element, and wherein the second arm is slidably attached to the handle.

21. The device of Claim 12, further comprising a fixed element.

22. The device of Claim 21, further comprising a first arm, and wherein the first arm is fixed to the first slidable element, and wherein the first arm is fixed to the fixed element;

23. The device of Claim 22, further comprising a second arm, and wherein the second arm is fixed to the second slidable element, and wherein the second arm is slidably attached to the fixed element.

24. A method for deploying an expandable device to a target site within a biological subject comprising: loading the expandable device on an expansion device, wherein the expansion device comprises a first slidable element and a second slidable element; locating the expandable device at the target site; expanding the expansion device, wherein expanding the expansion device comprises sliding the first slidable element relative to the second slidable element.

25. A method for expanding tissue at a target site within a biological subject comprising: inserting an expansion device into the target site or adjacent the target site, wherein the expansion device comprises a first slidable element and a second slidable element; expanding the expansion device, wherein expanding the expansion device comprises sliding the first slidable element relative to the second slidable element.

26. The method of Claim 25, wherein the tissue comprises bone

27. The method of Claim 25, wherein the tissue comprises a vertebra

28. The method of Claim 25, wherein the tissue comprises collagen.

29. The method of Claim 25, wherein the tissue comprises an intervertebral disc.