A device, such as a flexible spinal fusion cage, which can articulate or bend in such a way that it will be able to be implanted through bone (i.e., in a trans-osseous path, through bone, such as the Ilium and/or sacrum joint approach into L5-S1 is disclosed.
Typical lateral approach fusion implants are not able to implant fusion cages in the lower lumbar region for at least two reasons. First, boney obstacles can impair access.
Some doctors create large windows, shown in phantom lines in
Second, the approach angle of a tissue retractor relative to the location of the fusion site is an issue. The tissue retractor used in lateral fusion surgery provides line-of-site access to the disk space that is the target site for the fusion cage insertion. The retractor holds tissue out of the way. They also create a working channel to pass tools through, they protect neural tissue, and they anchor to the superior and inferior vertebral bodies relative to the disk space requiring fusion. Anything inferior to the iliac crest's lateral plane 10 is very hard, if not impossible, to reach with a direct lateral approach due to the physical obstruction created by the position and shape of the Ilium. Even if the retractors are tilted as shown by an L5-S1 delivery path 11a or L4-L5 delivery path 11b and respectively corresponding L5-S1 approach angle 12a and an L4-L5 approach angle 12b, the ability to insert an implant that is the length of the end plates of the L4 and L5 vertebral bodies would be very difficult.
Furthermore, with the retractor positioned in the plane and direction as shown by the delivery path 11a, the approach angle 12a formed between the delivery path 11a and the adjacent vertebral bodies' end plates would make inserting a monolithic fusion cage virtually impossible without severely damaging the surrounding vertebrae and/or the ilium.
Typical treatments for L5-S1 include anterior approaches include insertion through the front of the abdomen, transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF). Anterior and TLIF approaches are the most used. Both approaches are highly invasive and destructive to surrounding tissue.
Accordingly devices and methods for lumbar stabilization that are less destructive to surrounding tissues are desired. For example, a device and method of inserting a strong support device through a minimal channel in the ilium and/or ala that circumvent nerves and blood vessels is desired.
Support or fixation devices and methods for access, controlling (e.g., steering) implants, and modifying implants are disclosed.
The device can be an implantable fixation device, such as a flexible fusion cage. The device can articulate and/or bend so the device can be delivered through a channel in one or more bones and into the L5-S1 intervertebral space, as shown in
A stand-alone fusion system and method is disclosed that can include deploying the support device with the transosseous delivery approach and optionally deploying screws and using targeting fixtures.
A biological implant support device for providing orthopedic support is disclosed. The device can have a first rigid section, and a second rigid section. The first rigid section can be at a first terminal longitudinal end of the device. The second rigid section can be rotatably attached to the first rigid section at a longitudinal end of the first rigid section away from the first terminal longitudinal end of the device. The second rigid section can have threads.
The device can have an axle rotatably attaching the first rigid section to the second rigid section.
A system for providing orthopedic support is disclosed that can have the the support device described herein and a first screw attached to and extending away from device. The system can have a plug abutting the device.
A method for inserting a support device to a target site in a spine adjacent to a first vertebra is also disclosed. The method can include creating a tunnel or channel through the ala of the sacrum. The method can include inserting a first rigid section of the device through the channel and into the target site. The method can include inserting a second rigid section of the device into the tunnel. The method can include rotating the second rigid section of the implant with respect to the first rigid section. The first rigid section can be hingedly attached to the second rigid section. The method can include fixing the second rigid section of the implant in the tunnel.
Creating the channel can include drilling with a flexible drill. The channel can have a cylindrical cross-section. The non-vertebral bone can include the pelvis, the ilium, the sacrum, or combinations thereof.
Figures Ila and l lb are superior views of the sacrum and variations of methods for deploying multiple implant devices.
Implantable orthopedic support devices and methods for implanting the same that can access, control (i.e., steer) and deliver the devices into the L5-S1 disc space are disclosed. A tunnel or bone channel 22 can be drilled through the sacroiliac joint. The device 14 can be delivered through the bone channel 22 and into the L5-S1 joint space. The delivery method can be performed without disrupting nerves and major blood vessels. The implant has additional hardware to lock and/or stabilize the implant (e.g., to make an articulatible or flexible implant unarticulatible or rigid) and connect and attach the L5 vertebra to the S1 vertebra.
The support device 14 can be one or more flexible fusion devices, such as cages. The support devices 14 can articulate and/or bend, for example to be able to make a sharp turn from exiting a transosseous bone channel 22 and entering into the L5-S1 disc space. The support devices 14 can have rigid sections 24 connected by articulatable axes 26 (e.g., hinges), or rigid sections 24 and flexible lengths (e.g., lengths integrated with the rigid sections that are made from a more flexible material), or be flexible and/or resilient along the entire length of the device, or combinations thereof.
The bone channel 22 can be fitted with a collar or tube in contact with the perimeter of the channel. The collar or tube can be attached to a trocar. The tube can be delivered into the channel separate from a trocar. The tube can be hollow. The tube can have one, two, three or more lumens. The implant device can be inserted through a lumen in the tube. The tube lumen(s) can have a low friction internal surface. For example, the internal surface of the lumen(s) can be coated with PTFE (e.g., Teflon).
Access tools, such as elongated retractors that can be fit through the superficial incision and/or through the bone channel 22, can move soft tissue out of the way to create access to the channel from the outside of the patient's body. The distal end of the implant device 14 can be atraumatic. For example, the distal terminal end of the device 14 can have a rounded tip to spread or dissect tissue away from the delivery path 11 during translation of the device during delivery.
One or more deployment tools can deliver and deploy the support device 14. The deployment tools can attach to the support device 14 to allow the support device 14 to passively articulate or flex in response to resistive forces from surrounding tissue and/or to actively articulate or flex the support device 14 due to control inputs (e.g., pushing, twisting, button pressing, level manipulation, or combinations thereof) from the user. The interface or connection between the deployment tool and the support device 14 can manipulate the support device 14 by bending, flexing, steering, or combinations thereof. The deployment tool or tools can clear or debride the disk space (i.e., performing a partial or complete discectomy). The deployment tools can articulate and/or flex and follow the delivery paths shown for the support device 14 herein, for example to reach the L4-L5 and/or L5-S1 disc space. The deployment tools can be pre-angled to reach and remove intervertebral disk tissue, for example the deployment tool can be rigid and bent or can flex and articulate.
The support device 14 can fuse adjacent vertebrae to each other. The support device 14 can be used with securing (e.g., nails and screws, for example positioned through the support device 14 and one or both of the adjacent vertebrae) and/or targeting devices (e.g., radiopaque markers).
The proximal and/or distal ends of the support device 14 can have a porous bone ingrowth matrix on the outer surfaces of the support device 14, for example promoting bone growth into the support device 14 fixing the support device to surrounding bone (e.g., in the bone channel 22 and/or L4, L5, and/or S1). The proximal, distal or entire length of the support device 14 can be hollow, cannulated, threaded, have teeth, be expandable, barbed, be multiple pieces, or combinations thereof (e.g., to promote bone growth into the support device). Any or all of the hollow lengths of the support device 14 can be filling with the bone ingrowth matrix before, during or after the device 14 is positioned at the target site.
After the device 14 is positioned at the target site, a screw plug 28 can be inserted, as shown by arrow, through the bone channel 22. The screw plug 28 can have helical threads that can have an outer diameter larger than the diameter of the bone channel 22. The screw plug can be helically rotated through the bone channel 22. The screw plug 28 can fill the bone channel 22. The screw plug 28 can be at the distal or proximal end of the bone channel 22. The screw plug 28 can abut the device 14. The screw plug 22 can be made from PEEK, an allograft, Ti, PE, PMMA, milled bone, steel, any other material disclosed herein, or combinations thereof.
The outer diameter of the anchor screws 32 can be larger, smaller or the same as the inner diameter of the bone channel 22 or tube lumen inner diameter through which the respective screw is to be delivered. The proximal ends of the anchor screws 32 can be threaded or smooth (e.g., as an anchor pin). The proximal end of the anchor screws 32 can be can be inside a larger diameter plug smaller than, equal to or larger than the bone channel 22 or tube lumen inner diameter. The anchor screws 32 can be rigid.
Each bone channel 22 can have a medial bone channel port 36a and lateral bone channel port 36b.
Any or all elements of the 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, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 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, Del.), polypropylene, (PET), 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, Mass.), 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.
Any or all elements of the 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, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof.
The device and/or elements of the device 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.
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.
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-1) 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, N.J.; CELEBREX® from Pharmacia Corp., Peapack, NJ; COX-1 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 Prostoglandin E2 Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 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, Spl 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.
U.S. Pat. No. 13/592,271 and PCT Application No. U.S. Ser. No. 12/51945, both filed Aug. 22, 2012, are incorporated by reference herein in their entireties. The broach can be used to perform the discectomy. The elements and characteristics of the broach can be the same as those for the support device 14.
Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.
The present application is a continuation of U.S. patent application Ser. No. 15/261,520 filed Sep. 9, 2016, which is a divisional of U.S. patent application Ser. No. 14/730,147 filed Jun. 3, 2015, now abandoned, which is a continuation of U.S. patent application Ser. No. 13/573,542 filed Sep. 21, 2012, now abandoned, which claims the benefit of U.S. Provisional Application No. 61/537,386 filed Sep. 21, 2011, each of which are herein incorporated by reference in its entirety.
Number | Date | Country | |
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61537386 | Sep 2011 | US |
Number | Date | Country | |
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Parent | 14730147 | Jun 2015 | US |
Child | 15261520 | US |
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Parent | 15261520 | Sep 2016 | US |
Child | 16403374 | US | |
Parent | 13573542 | Sep 2012 | US |
Child | 14730147 | US |