WO2007076374A2 - Expandable support device and method of using the same - Google Patents

Expandable support device and method of using the same Download PDF

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Publication number
WO2007076374A2
WO2007076374A2 PCT/US2006/062333 US2006062333W WO2007076374A2 WO 2007076374 A2 WO2007076374 A2 WO 2007076374A2 US 2006062333 W US2006062333 W US 2006062333W WO 2007076374 A2 WO2007076374 A2 WO 2007076374A2
Authority
WO
WIPO (PCT)
Prior art keywords
frame
support device
expandable support
side
device
Prior art date
Application number
PCT/US2006/062333
Other languages
French (fr)
Other versions
WO2007076374A3 (en
Inventor
Skott E. Greenhalgh
Original Assignee
Stout Medical Group, L.P.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US75191905P priority Critical
Priority to US60/751,919 priority
Application filed by Stout Medical Group, L.P. filed Critical Stout Medical Group, L.P.
Publication of WO2007076374A2 publication Critical patent/WO2007076374A2/en
Publication of WO2007076374A3 publication Critical patent/WO2007076374A3/en

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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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Abstract

A device for providing support for biological tissue is disclosed. The device can expand and be implanted in lieu of removed or otherwise missing bone, such as a vertebra, and/or soft tissue, such as a intervertebral disc. The device can be configured to radially expand when the device is longitudinally contracted. Methods for using the device are also disclosed.

Description

TITLE OF THE INVENTION EXPANDABLE SUPPORT DEVICE AND METHOD OF USING THE SAME E. Skott Greenhalgh

CROSS-REFERENCE TO RELATED APPLICATIONS |0001] This application claims the benefit of U.S. Provisional Application No. 60/751,919, filed 19 December 2005, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention [0002J This invention relates to devices for providing support for biological tissue, for example to repair spinal compression fractures, and methods of using the same. [0003] Vertebra replacement and/or vertebroplasty procedures are performed to partially or completely replace or strengthen a broken vertebra that has been weakened by disease, such as osteoporosis or cancer. These procedures are often used to treat compression fractures, such as those caused by osteoporosis, cancer, or stress. Vertebroplasty is commonly performed as an image-guided, minimally invasive therapy. [0004] Verlebroplasty is often performed on patients too elderly or frail to tolerate open spinal surgeiy, 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 device and method that eliminates or reduces the risks and complexity of the existing art is desired. A device and method that is not based on injecting a liquid directly into the compression fracture zone is desired.

BRIEF SUMMARY OF THE INVENTION [0009] An expandable support device for performing completely implantable spinal repair is disclosed. The device has a first strut and a second strul attached to, and/or integral with, the first strut. The first strut is substantially deforniable. The second strut can be substantially inflexible. [0010] The device can be configured to expand in a single direction. The device can be configured to expand in two directions, for example in two radial directions (e.g., up and down). [0011] The device can have a buttress. The buttress can have, for example, a coil, a wedge, and/or a hoop. [0012] The device can have a locking pin. The locking pin can be interference fit with the device, for example with the first strut, and/or with a longitudinal port of the device. [0013] A method for repairing a damaged section of a spine is also disclosed. The method includes expanding an expandable support device in the damaged section. The expandable support device is loaded on a balloon during the expanding. Expanding can include inflating a balloon and/or longitudinally compressing the expandable support device. Inflating the balloon can include inflating the balloon equal to or greater than about 5,000 kPa of internal pressure, or equal to or greater than about 10,000 kPa of internal pressure.

BRIEF DESCRIPTION OF THE DRAWINGS [0014) Figure 1 is a perspective view of a variation of the expandable support device. [0015] Figure 2 is a side view of the variation of the expandable support device of Figure 1. [0016J Figure 3 is a top view of the variation of the expandable support device of Figure 1. [0017] Figure 4 is a front view of the variation of the expandable support device of Figure 1. [0018] Figure 5 is a perspective view of a variation of the expandable support device. [0019] Figure 6 is a side view of the variation of the expandable support device of Figure 5. [0020] Figure 7 is a front view of the variation of the expandable support device of Figure 5. [0021] Figure 8 is a perspective view of a variation of the expandable support device. [0022] Figure 9 is a front view of the variation of the expandable support device of Figure 8. [0023] Figure 10 illustrates a flattened pattern for a variation of the expandable support device. |0024| Figure 11 is a perspective view of a variation of the expandable support device. [0025] Figure 12 is a front view of the variation of the expandable support device of Figure 11. [0026] Figure 13 is a perspective view of a variation of the expandable support device. [0027] Figure 14 is a front view of the variation of the expandable support device of Figure 13. [0028] Figure 15 is a perspective view of a variation of the expandable support device. [0029J Figure 16 is top view of the variation of the expandable support device of Figure 15. [0030] Figure 17 is a side view of the variation of the expandable support device of Figure 15. [0031] Figure 18 is a front view of the variation of the expandable support device of Figure 15. [0032] Figure 19 illustrates a variation of section A-A of the variation of the expandable support device of Figure 15. [0033] Figure 20 illustrates a variation of section B-B of the variation of the expandable support device of Figure 15. [0034] Figure 21 is a perspective view of a variation of the expandable support device. [0035] Figure 22 is top view of the variation of the expandable support device of Figure 15. [0036| Figure 23 is a front view of the variation of the expandable support device of Figure 15. [0037| Figure 26, not the invention, illustrates a variation of a vertebral column with a damage site. [0038] Figure 27 illustrates a method of a variation of removing a damaged solid body from a vertebral column. [0039] Figures 28 through 30 illustrate a method of deploying one or more expandable support devices into the damage site. [0040] Figure 31 illustrates a method of a variation of removing a portion of a damaged solid body from a vertebral column. [0041] Figures 32 and 33 illustrate a method of deploying the expandable support device into the damage site. [0042] Figures 34 through 41 illustrate a variation of a method for deploying a locking pin into the expandable support device. [0043] Figure 42 illustrates a variation of the buttress. [0044] Figures 43 through 45 illustrate variations of section C-C of the buttress of Figure 42. [0045] Figures 46 through 48 illustrate a variation of a method for deploying the buttress. [0046] Figure 49 illustrates a variation of a method for deploying the buttress. [0047] Figures 50 through 52 illustrate a variation of a method for deploying the buttress [0048] Figure 53 illustrates a variation of the buttress. [0049] Figure 54 illustrates a variation of section D-D of the buttress of Figure 53. [0050] Figure 55 illustrates a variation of a method for deploying the buttress. [0051 J Figures 56 through 59 illustrate a method for deploying the expandable support device of Figures 1 through 4. [0052] Figures 60 through 62 illustrate a method for deploying the expandable support device of Figures 15 through 18. [0053] Figure 63 illustrates the deployed expandable support device of Figures 15 through 18 in use. |0054| Figures 64 and 65 illustrate a method for deploying the expandable support device of Figures 19 and 20. [0055] Figure 66 illustrates a method of using the expandable support device of Figures 15 through 18 with the band. [0056| Figure 67 through 69 illustrate variations of the locking pin.

DETAILED DESCRIPTION [0057| Figures 1 through 4 illustrate an biocompatible implant that can be used for tissue repair, for example for repair bone fractures such as spinal compression fractures, and/or repairing soft tissue damage, such as herniated vertebral discs. The implant can be an expandable support device 2, for example a stent. The expandable support device 2 can have a longitudinal axis 4. The expandable support device 2 can have an elongated wall 6 around the longitudinal axis 4, The expandable support device 2 can have a substantially and/or completely hollow longitudinal port 8 along the longitudinal axis 4. [0058J The wall 6 can have one or more first struts 10. The first struts 10 can be configured to be deformable and/or expandable. The wall 6 can have can have one or more second stints 12. The second struts 12 can be substantially undeformable and substantially inflexible. The first struts 10 can be flexibly (e.g., deformably rotatably) attached to the second struts 12. [0059] The wall 6 can be configured to expand radially away from the longitudinal axis 4, for example in two opposite radial directions. A first set of first struts 10 can be aligned parallel to each other with respect to the longitudinal axis 4. A second set of first struts 10 can be aligned parallel to each other with respect to the longitudinal axis 4. The second set of first struts 10 can be on the opposite side of the longitudinal axis 4 from the first set of first struts 10. The second struts 12 can attached any or all sets of first struts 10 to other sets of first struts 10. [0060] The second struts 12 can have one or more ingrowth ports 14. The ingrowth ports 14 can be configured to encourage biological tissue ingrowth therethrough during use. The ingrowth ports 14 can be configured to releasably and/or fixedly attach to a deployment tool or other tool. The ingrowth ports 14 can be configured to increase, and/or decrease, and/or focus pressure against the surrounding biological tissue during use. The ingrowth ports 14 can be configured to increase and/or decrease the stiffness of the second struts 12. The ingrowth ports 14 can be configured to receive and/or attach to a buttress, |0061] The first struts 10 can be configured to have a "V", "U", "C", or "W" shape, or combinations thereof. The space between adjacent first struts 10 can be configured to receive and/or attach to a locking pin during use. [0062] The wall 6 can have a wall thickness 16. The wall thickness 16 can be from about 0.25 mm (0.098 in.) to about 5 mm (0.2 in.), for example about 1 mm (0.04 in.). The wall 6 can have an inner diameter 18. The inner diameter 18 can be from about 1 mm (0.04 in.) to about 30 mm ( 1.2 in.), for example about 6 mm (0.2 in.). The wall thickness 16 and/or the inner diameter 18 can vary with respect to the length along the longitudinal axis 4. The wall thickness 16 and/or the inner diameter 18 can vary with respect to the angle formed with a plane parallel to the longitudinal axis 4. [0063] Figures 5 through 7 illustrate an expandable support device 2 that can be configured to expand away from the longitudinal axis 4 in more than two opposite directions, for example in two sets of two opposite radial directions. The wall 6 can have four sets of first struts 10. Each set of first struts 10 can be opposite to another set of first struts 10, radially with respect to the longitudinal axis 4. Each of four sets of second struts 12 can attach each set of first struts 10. [0064] The first struts 10 on a first longitudinal half of the expandable support device 2 can be oriented (e.g., the direction of the pointed end of the "V" shape) in the opposite direction as the first struts 10 on a second longitudinal half of the expandable support device 2. [0065] Figures 8 and 9 illustrate that the longitudinal port 8 can have one or more lock grooves 20. The lock grooves 20 can be configured to receive and/or slidably and fixedly or releasably attach to a locking pin. |0066] Figure 10 illustrates a visually flattened pattern of the wall 6 for the expandable support device 2. (The pattern of the wall 6 can be flattened for illustrative purposes only, or the wall 6 can be flattened during the manufacturing process.) The pattern can have multiple configurations for the first and/or second struts 10 and/or 12. For example, first struts 10a can have a first configuration (e.g., a "V" shape) and first struts 10b can have a second configuration (e.g., a "U" shape). [0067] Figures 11 and 12 illustrate that the expandable support device 2 can have a square, rectangular, circular (shown elsewhere), oval (not shown) configuration or combinations thereof (e.g., longitudinal changes in shape). [0068| Figures 13 and 14 illustrate that the expandable support device 2 can have protruding tissue engagement elements, such as tissue hooks, and/or barbs, and/or cleats 22. The cleats 22 can be integral with and/or fixedly or removably attached to the first and/or second struts 12. The cleats 22 can be on substantially opposite sides of the expandable support device 2. [0069] Figures 15 through 18 illustrate thai the expandable support device 2 can have panels attached to other panels at flexible joints. The expandable support device 2 can have first panels 24 attached to and/or integral with second panels 26 at first joints 28. The second panels 26 can be attached to and/or integral with third panels 30 at second joints 32. The expandable support device 2 can have one or more tool engagement ports 34, for example on the first panels 24. The expandable support device 2 can have one or more ingrowth ports 14, for example, on the third panels 30. The outside of the first panel 24 can be concave. [0070] Figures 19 and 20 illustrate that the expandable support device 2 can have first and/or second struts 10 and/or 12 and panels. The first and/or second struts 10 and/or 12 can be internal to the panels. The first struts 10 can be attached to the third panels 30. [0071] Figures 21 through 23 illustrate the expandable support device 2 that can have a radius of curvature 36 along the longitudinal axis 4. The radius of curvature 36 can be from about 1 mm (0.04 in.) to about 250 mm (10 in.), for example about 50 mm (2 in.). (The wall 6 is shown sans panels or struts for illustrative purposes.) The expandable support device 2 can have at least one flat side, for example two flat sides. The two flat sides can be on opposite sides of the expandable support device 2 from each other. [0072] Any or all elements of the expandable support device 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), poly ester amide (PEA), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high- performance polyethylene) fiber and/or yarn (e.g., SPECTRA© Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, NJ, or DYNEEMA® from Royal DSM N. V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE). expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), 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), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded or packed collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomalerial (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. |0073| Any or all elements of the expandable support device 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). poly ester amide (PEA), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone, any other material disclosed herein, or combinations thereof. [0074] The expandable support device and/or elements of the expandable support device and/or other devices or apparatuses described herein and/or the fabric can be filled, coaled, 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. [0075] 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. [0076] 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 antiinflammatories (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, CollegevilJe, 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 (Geiatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties. [0077] Figure 24 illustrates that the expandable support device 2 can be loaded in a collapsed (i.e., contracted) configuration onto a deployment tool 38. The deployment tool 38 can have an expandable balloon catheter as known to those having an ordinary level of skill in the art. The deployment tool 38 can have a catheter 40. The catheter 40 can have a fluid conduit 42. The fluid conduit 42 can be in fluid communication with a balloon 44. The balloon 44 and the deployment tool 38 can be the balloon 44 and deployment tool 38 as described by U.S. Provisional Patent Application Titled "BALLOON AND METHODS OF MAKING AND USING'", filed 21 September 2004, Attorney Docket No. P005, which is herein incorporated by reference in its entirety. The balloon 44 can be configured to receive a fluid pressure of at least about 5,000 kPa (50 atm), more narrowly at least about 10,000 IcPa (100 ami), for example at least about 14,000 kPa (140 atm). [0078] The deployment tool 38 can be a pair of wedges, an expandable jack, other expansion tools, or combinations thereof. [0079] Figure 25 illustrates that the fluid pressure in the fluid conduit 42 and balloon can increase, thereby inflating the balloon 44, as shown by arrows. The expandable support device 2 can expand, for example, due to pressure from the balloon 44. [0080] Figure 26 illustrates that a vertebral column 46 can have one or more vertebra 48 (e.g., a first vertebra 48a and a second vertebra 48b). The vertebral column 46 can have a damage site 52, for example at a damaged third vertebra 48c. The third vertebra 48c can have a compression fracture and/or other degradation or damage. [00811 Figure 27 illustrates that the damaged third vertebra 48c can be removed, as shown by arrow, from the vertebral column 46. The third vertebra 48c can be removed during an open procedure or the third vertebra 48c can be removed during a minimally invasive procedure (e.g., by applying suction to the third vertebra 48c, and further grinding and/or chopping the third vertebra 48c, such as with a drill or contained blender or morselizer, internally if necessary for removal through a catheter). Intervertebral discs 50 on one or both sides of the damaged third vertebra can be completely removed, as shown by arrow, from the vertebral column 46. The vertebral column 46 can have the damage site 52 between the first vertebra 48a and the second vertebra 48b. An intervertebral gap 49 can exist between the first vertebra 48a and the second vertebra 48b. The intervertebral gap 49 can have a pre-treatment gap height 51a. (0082) Figure 28 illustrates that one, two or more expandable support devices 2 can be inserted into the intervertebral gap 49 to treat the damage site 52. A first deployment tool 38a can enter through the subject's back. The first deployment tool 38a can enter through a first incision 66a, for example a minimal or open incision, in skin 68 on the posterior side of the subject near the vertebral column 46. The first deployment tool 38a can be steerable. The first deployment tool 38a can be translated, as shown by arrow 70, to position a first expandable support device 2a into the damage site 52. [0083) A second deployment tool 38b can enter through a second incision 66b (as shown) in the skin 68 on the posterior side of the patient or the first incision 66a. The second deployment tool 38b can be translated through muscle (not shown), around nerves 72, and anterior of the vertebral column 46. The second deployment tool 38b can be steerable. The second deployment tool 38b can be steered, as shown by arrow 74, to align the distal tip of the second expandable support device 2b for an anterior, lateral, or otherwise non-posterior entry to the damage site 52. The second deployment tool 38b can translate, as shown by arrow 76, to position the second expandable support device 2b in the damage site 52. [0084] The expandable support devices 2 can be deployed from the anterior, posterior, both lateral, superior, inferior, any angle, or combinations of the directions thereof. [0085] Figure 29 illustrates that the expandable support device 2 can be integral with and/or attached to one or more soft tissue replacements, such as a first intervertebral disc replacement 200a and/or a second intervertebral disc replacement 200b. One, two, or more of the intervertebral disc replacements 200 can be an integral part of, or separate from, the expandable support device 2. The first intervertebral disc replacement 200a can be on the first vertebra 48a side of the expandable support device 2. The second intervertebral disc replacement 200b can be on the second vertebra 48b of the expandable support device 2. [0086] The intervertebral disc replacements can be a closed plate and/or a large diameter plate. The intervertebral disk replacements can be a pads or pressure dissipaters. The intervertebral disc replacements can distribute the mechanical load and/or to prevent or minimize migration of the expandable support device 2 into surrounding bones (e.g., the first and second vertebra 48a and 48b), and/or migration of any remaining portions or fragments of the third vertebra 48c into the expandable support device 2. [0087] The intervertebral disc replacements 200 can be made from a synthetic and/or biological material. For example, the intervertebral disc replacements 200 can be made from any of the materials disclosed, supra. The intervetebral disc replacements 200 can be made from cartilage. The intervetebral disc replacements 200 can be made from cartilage on a metal and/or polymer frame or scaffold. The intervertebral disc replacements 200 can be made of a material and design to replicate the function of natural intervertebral discs. The intervertevral disc replacements 200 can be entirely or partially allograft, autograft, xenograft, or combinations thereof. [0088] The intervertebral disc replacements 200 can have one or more matrices, for example or ingrowth of surrounding tissue (e.g., bone). The intervertebral disc replacements 200 can be configured to be fϊxably or removable attachable to the expandable support device 2. The intervertebral disc replacements 200 can be deployed to the target site before, and/or simultaneous with, and/or after the deployment of the expandable support device 2 to the target site. [0089| The expandable support device 2 can expand radially (e.g., in the direction of a longitudinal axis of the vertebral column 46), as shown by arrows. The radial expansion of the expandable support devics 2 can be resilient and or forced deformation. The expandable support device 2 can exert an expansion force 202 on the first and second vertebra 48a and 48b. [0090] Figure 30 illustrates that the expandable support device 2 can radially expand, as shown by arrows. A post-treatment gap height 51b can be larger than the pre- treatment gap height 51a. The pre-treatment gap height 51 a can be, for example, the same length as the gap height before the damage site 52 was formed and/or the gap height before all or part of the damaged third vertebra 53 c was removed. [0091] Figure 31 illustrates that a portion of the damaged third vertebra 48c can be removed, as shown by arrow. Figure 32 illustrates that the expandable support device can be sized to fit in the damage site 52 if a portion of the third vertebra 48c remains in the vertebral column 46. [0092| Figure 33 illustrates that the expandable support device 2 can be in a radially expanded configuration. The expandable support device 2 can abut or otherwise be adjacent to the remaining portion of the third vertebra 48c. A bone-side element 204 can be attached to and/or integral with the expandable support device 2 and/or the remaining portion of the third vertebra 48c. The bone side element 204 can be between the expandable support device 2 and the remaining portion of the third vertebra 48c. The bone side element can, for example, to distribute the mechanical load and/or to prevent or minimize migration of the expandable support device 2 into surrounding bones (e.g., the remaining portion of the third vertebra 48c). and/or migration of any remaining portions or fragments of the third vertebra 48c into the expandable support device 2. [0093] The expandable support device 2 can be inserted into the intervertebral gap 49, used to increase the gap length 51 , and removed from the damage site 52. An alternate support device (not shown) can be inserted in the damage site 52, and/or the expandable support device 2 can remain in the damage site 52 indefinitely. [0094| Figures 34 and 35 illustrate that a locking pin 86 can be inserted, as shown by arrow, into the deployed expandable support device 2, for example, after the expandable support device 2 is deployed in the between the first and second vertebra 48a and 48b. The locking pin 86 can, for example, prevent the expandable support device 2 from collapsing after the expandable support device 2 is deployed in the vertebra 48. The locking pin 86 can form an interference fit with the expandable support device 2. [0095] The locking pin 86 can be parallel with the longitudinal axis 4, as shown in Figure 34, for example when the locking pin 86 is slidably received by and/or attached to the lock grooves 20. The locking pin 86 can be perpendicular to the longitudinal axis 4, as shown in Figure 35, for example when the locking pin 86 is slidably received by and/or attached to ports formed between adjacent first struts 10 after the expandable support device 2 is expanded. [0096] Figures 36 through 41 illustrate a method for deploying the locking pin 86 into the expandable support device 2. As shown in Figures 36 and 37, the locking pin 86 can be translated, as shown by arrow, into the expandable support device 2. As shown in Figure 38, a first end of the locking pin 86 can be translated, as shown by arrow, into a first port formed between adjacent first struts 10. As shown by Figure 39, a second end of the locking pin 86 can be rotated, as shown by arrow. As shown by Figure 40, the second end of the locking pin 86 can be translated, as shown by arrow, into a second port formed between adjacent first struts 10. Figure 41 shows the locking pin 86 deployed into, and forming an interference Fit with, the expandable support device 2. [0097] Figure 42 illustrates a buttress 88. The buttress 88 can have a longitudinal axis 4. The buttress 88 can have a tensioner 90. A first end of the tensioner 90 can be fixedly or removably attached a first end of the buttress 88. A second end of the tensioner 90 can be fixedly or removably attached a second end of the buttress 88. The tensioner 90 can be in a relaxed configuration when the buttress 88 is in a relaxed configuration. The tensioner 90 can create a tensile force between the first end of the buttress 88 and the second end of the buttress 88 when the buttress 88 is in a stressed configuration. The tensioner 90 can be, for example, a resilient wire, a coil spring, an elastic member, or combinations thereof. [0098] The buttress 88 can have a coil 92. The coil 92 can have turns 94 of a wire, ribbon, or other coiled element. Figures 43 through 45 illustrate that the coil can be made from a wire, ribbon, or other coiled element having a circular, square, or oval cross-section, respectively. [0099] The buttress 88 can be a series of connected hoops. [0100] Figure 46 illustrates that the buttress 88 can be loaded into a hollow deployment tool 38 in a smear (i.e., partially shear stressed) configuration. The buttress 88 in the smear configuration can have a relaxed first end 96, a stressed smear section 98, and a relaxed second end 100. The longitudinal axis 4 can be not straight (i.e., non-linear) through the smear section 98. |0101] Figure 47 illustrates that part of the buttress 88 can be forced, as shown by arrow, out of the deployment tool 38. The second end 100 can exit the deployment tool 38 before the remainder of the buttress 88. The smear section 98 can then partially relax. The second end 100 can be positioned to a final location before the remainder of the buttress 88 is deployed from the deployment tool 38. [0102] Figure 48 illustrates that the remainder of the buttress 88 can be forced, as shown by arrow, out of the deployment tool 38. The smear section 98 can substantially relax. The longitudinal axis 4 can return to a substantially relaxed and/or straight (i.e., linear) configuration. [0103] Figure 49 illustrates that the buttress 88 can be deployed in the expandable support device 2, for example with the longitudinal axis 4 of the buttress 88 or the strongest orientation of the buttress 88 aligned substantially parallel with the primary load bearing direction (e.g., along the axis of the spine) of the expandable support device 2. [0104| Figure 50 illustrates that the buttress 88 can be loaded into the hollow deployment tool 38 with the longitudinal axis 4 of the buttress 88 substantially parallel with the hollow length of the deployment tool 38. The entire length of the buttress 88 can be under shear stress. [0105] Figure 51 illustrates that part of the buttress 88 can be forced, as shown by arrow, out of the deployment tool 38. The second end of the buttress 88 can exit the deployment tool 38 before the remainder of the buttress 88. The tensioner 90 can apply a tensile stress between the ends of the buttress 88, for example, forcing the deployed second end of the buttress 88 to "stand up straight". The second end of the buttress 88 can be positioned to a final location before the remainder of the buttress 88 is deployed from the deployment tool 38. [0106] Figure 52 illustrates that the remainder of the buttress 88 can be forced, as shown by arrow, out of the deployment tool 38. The buttress 88 can substantially relax. [0107] Figure 53 illustrates that the buttress can have a first wedge 102 and a second wedge 104. The first wedge 102 can contact the second wedge 104 at a directionally locking interface 106. The directionally locking interface 106 can have directional teeth 108. [0108] Figure 54 illustrates that the first wedge 102 can be slidably attached to the second wedge 104. The first wedge 102 can have a tongue 110. The second wedge 104 can have a groove 1 12. The tongue 110 can be slidably attached to the groove 112. [0109] A wedge gap 114 can be between the tongue 1 10 and the groove 112. The wedge gap 114 can be wider than the height of the teeth 108. The wedge gap 1 14 can be configured to allow the first wedge 102 to be sufficiently distanced from the second wedge 104 so the teeth 108 on the first wedge 102 can be disengaged from the teeth 108 on the second wedge 104. [0110] The buttress 88 in a compact configuration can be placed inside of the longitudinal port 8 of the deployed expandable support device 2. Figure 55 illustrates that the first λvedge 102 can then be translated, as shown by arrows, relative to the second wedge 104 along the directionally locking interface 106. The first wedge 102 can abul a first side of the inside of the deployed expandable support device 2. The second wedge 104 can abut a second side of the inside of the deployed expandable support device 2. The directionally interference fitting teeth 108 can prevent disengagement of the buttress 88. A stop 1 16 can limit the relative translation of the first wedge 102 and the second wedge 104. 10111) Figures 56 through 59 illustrate the expandable support device 2 of Figures 1 through 4 that can be in a deployed configuration. The first struts 10 can be expanded, as shown by arrows 118. The expandable support device 2 can passively narrow, as shown by arrows 120. The expandable support device 2 can be deployed in a configuration where the second struts 12 can be placed against the load bearing surfaces of the deployment site. [0112] The expandable support device 2 can have a minimum inner diameter 122 and a maximum inner diameter 124. The minimum inner diameter 122 can be less than the pre-deployed inner diameter. The minimum inner diameter 122 can be from about 0.2 mm (0.01 in.) to about 120 mm (4.7 in.), for example about 2 mm (0.08 in.), be from about 1.5 mm (0.060 in.) to about 40 mm (2 in.), for example about 8 mm (0.3 in.). The maximum inner diameter 124 can be more than the pre-deployed inner diameter. The maximum inner diameter 124 can be from about 1.5 mm (0.060 in.) to about 120 mm (4.7 in.), for example about 18 mm (0.71 in.). [0113J Figures 60 through 62 illustrate the expandable support device 2 of Figures 15 through 18 that can be in a deployed configuration. A tool (not shown) can releasably attach to the tool engagement port 34. The tool can be used to position the expandable support device 2. The tool can be used to expand the expandable support device 2, for example, by forcing the first panels 24 toward each other. [0114] The second joints 32 can form angles less than about 90°. As shown in Figure 63, a compressive force, as shown by arrows 126, causes additional inward deflection, as shown by arrows 128, of the first panels 24. and will not substantially compress the expandable support device 2. [0115] Figure 64 illustrates a deployed configuration of the expandable support device 2 of Figures 19 and 20. The first struts 10 can expand to the size of the expandable support device 2. Figure 65 illustrates that the first struts 10 can touch each other, for example if the expandable support device 2 is sufficiently expanded. In the case of extreme compressive loads applied to the expandable support device 2, the first struts 10 can buckle into each other, thereby providing additional resistance to compressive loads. [0116] Figure 66 illustrates the expandable support device 2 that can have one or more bands 130. The bands 130 can be attached to other bands 130 and/or attached to the expandable support device 2 with band connectors 132. The bands 130 can be attached to the expandable support device 2 before, during, or after deployment. The bands 130 can increase the compressive strength of the expandable support device 2. [0117] Figure 67 illustrates the locking pin 86 that can be configured to fit into the longitudinal port 8, for example, of the expanded expandable support device 2 of Figures 56 through 59. Figure 68 illustrates the locking pin 86 that can be configured to fit into the longitudinal port 8, for example, of the expanded expandable support device 2 of Figures 60 through 63. Figure 69 illustrates the locking pin 86 that can be configured to fit into the longitudinal port 8, for example, of the expanded expandable support device 2 of Figures 8 and 9 and/or Figures 11 and 12. [0118] Once the expandable support device 2 is deployed, the longitudinal port 8 and the remaining void volume in the damage site 52 can be filled with, for example, biocompatible coils, bone cement, morselized bone, osteogenic powder, beads of bone, polymerizing fluid, paste, a matrix (e.g., containing an osteogenic agent and/or an anti-inflammatory agent, and/or any other agent disclosed supra), Orthofix, cyanoacrylate, any other agents or materials disclosed herein, or combinations thereof. [0119| The expandable support device 2 can be implanted in the place of all or part of a vertebral disc 50. For example, if the disc 50 has herniated, the expandable support device 2 can be implanled into the hernia in the disc annulus. and/or the expandable support device 2 can be implanted into the disc nucleus. [0120| Additional variations of the expandable support device 2 and methods for use of the expandable support device, as well as devices for deploying the expandable support device 2 and methods for use thereof can include those disclosed in the following applications which are all incorporated herein in their entireties: PCT Application No. PCT/US2005/0341 15, filed 21 September 2005; U.S. Provisional Patent Application No. 60/675,543, filed 27 April 2005; PCT Application No. PCT/US2005/034742, filed 26 September 2005; PCT Application No. PCT/US2005/034728, filed 26 September 2005; PCT Application No. PCT/US2005/037126, filed 12 October 2005: U.S. Provisional Patent Application No. 60/723,309, filed 4 October 2005; U.S. Provisional Patent Application No. 60/675,512, filed 27 April 2005; U.S. Provisional Patent Application No. 60/699,577, filed 14 July 2005; and U.S. Provisional Patent Application No. 60/699,576, filed 14 July 2005. [0121] 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 variation are exemplary for the specific variation and can be in used on or in combination with other variations within this disclosure.

Claims

CLAIMS I claim: 1. An expandable device for orthopedic support comprising: an expandable frame having a frame first side and a frame second side; and a first soft tissue replacement attached to the frame first side.
2. The device of Claim 1, further comprising a second soft tissue replacement attached to the frame first side
3. The device of Claim 2, wherein the frame first side is substantially opposite to the frame second side.
4. The device of Claim 1, wherein the first soft tissue replacement is removably attached to the frame first side.
5. The device of Claim 1, wherein the first soft tissue replacement comprises a biological material.
6. The device of Claim 1, wherein the first soft tissue replacement comprises a synthetic material.
7. An expandable device for orthopedic support comprising: an expandable frame having a frame first side and a frame second side; and a first soft tissue replacement integrated with the frame first side
8. The device of Claim 7, further comprising a second soft tissue frame integrated with the frame second side.
9. The device of Claim 8, wherein the frame first side is substantially opposite to the frame second side.
10. The device of Claim 7, wherein the first soft tissue replacement comprises a biological material.
11. The device of Claim 7, wherein the first soft tissue replacement comprises a synthetic material.
12, A method for treating orthopedic damage at a treatment site having an adjacent first bone and an adjacent second bone, wherein a first gap exists between the adjacent first bone and the adjacent second bone, the method comprising: inserting an expandable support device into the treatment site, expanding the expandable support device, wherein expanding comprises contacting the adjacent first bone with the expandable support device and contacting the adjacent second bone with the expandable support device; and increasing the first gap.
13. The method of Claim 12, wherein increasing the first gap comprises further expanding the expandable support device.
14. The method of Claim 12, wherein the expandable support device has an expandable frame, and wherein the expandable frame has a frame first side and a frame second side, and the method further comprises attaching a first soft tissue replacement to the frame first side.
15. The method of Claim 14, the method further comprises attaching a second soft tissue replacement to the frame second side.
16. The method of Claim 12, wherein the expandable support device has an expandable frame, and wherein the expandable frame has a frame first side and a frame second side, and the method further comprises inserting a first soft tissue replacement between the frame first side and the adjacent first bone.
17. The method of Claim 16, further comprising inserting a second soft tissue replacement between the frame second side and the adjacent second bone.
18. The method of Claim 12, further comprising removing bone at the treatment site
19. The method of Claim 18, wherein removing bone comprises removing a portion of a vertebra.
20. The method of Claim 19, wherein removing bone comprises removing a vertebra.
PCT/US2006/062333 2005-12-19 2006-12-19 Expandable support device and method of using the same WO2007076374A2 (en)

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