Patent Application
20140012340
The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a sacro-iliac joint.
The sacro-iliac joint is a diarthrodial joint that joins the sacrum to the ilium bones of the pelvis. In the sacro-iliac joint, the sacral surface has hyaline cartilage that moves against fibrocartilage of the iliac surface. The spinal column is configured so that the weight of an upper body rests on the sacro-iliac joints at the juncture of the sacrum and ilia. Stress placed on the sacro-iliac joints in an upright position of the body makes the lower back susceptible to injury.
Disorders of the sacro-iliac joint can cause low back and radiating buttock and leg pain in patients suffering from degeneration and laxity of the sacro-iliac joint. In some cases, the sacro-iliac joint can undergo dehydration and destabilization, similar to other cartilaginous joints, which causes significant pain. The sacro-iliac joint is also susceptible to trauma and degeneration, from fracture and instability. It is estimated that disorders of the sacro-iliac joint are a source of pain for millions of people suffering from back and radicular symptoms.
Non-surgical treatments, such as medication, injection, mobilization, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these disorders includes stabilization and/or arthrodesis. Stabilization can include the use of implants, such as, for example, bone screws that are fixed with bone. Arthrodesis may include immobilization of a joint. The present disclosure describes an improvement over these prior art technologies.
Accordingly, a surgical system and method are provided for treating the sacro-iliac joint. It is contemplated that the system may include an implant configured for disposal with the sacro-iliac joint. It is further contemplated that the surgical system and method may be employed for an arthrodesis treatment.
In one embodiment, in accordance with the principles of the present disclosure, a method for treating a sacro-iliac joint is provided. The method comprising the steps of: identifying a target of a posterior superior iliac spine of a body; determining a selected trajectory that includes the target and at least a portion of a sacrum of the body; creating a pathway in the body along the selected trajectory from a posterior approach to the body; and delivering an implant along the pathway such that the implant is disposed for fixation with an ilium of the body and the sacrum.
In one embodiment, a method for treating a sacro-iliac joint is provided. The method comprising the steps of: identifying a target of a posterior superior iliac spine of a body, the body having an ilium defining a first cortical layer and a second cortical layer, and a sacrum defining a first cortical layer and a second cortical layer; creating an incision in the body adjacent the posterior superior iliac spine; disposing a guidewire at the target; advancing the guidewire from the target along the sacro-iliac joint and into the sacrum along a selected trajectory; confirming the selected trajectory with medical imaging; creating a pathway along the selected trajectory from a posterior approach to the body, the pathway extending from at least the target through the cortical layers of the ilium and the first cortical layer of the sacrum; and delivering an implant along the pathway such that the implant extends through the second cortical layer of the ilium and the first cortical layer of the sacrum and is disposed for fixation with the ilium and the sacrum.
In one embodiment, a method for treating a sacro-iliac joint is provided. The method comprising the steps of: disposing a body in a prone position on a surface; identifying a target of a posterior superior iliac spine of the body, wherein the body defines a vertical axis extending from the target and the selected trajectory is disposed along a transverse axis relative to the vertical axis, the body having an ilium defining a first cortical layer and a second cortical layer, and a sacrum defining a first cortical layer and a second cortical layer; creating an incision in the body adjacent the posterior superior iliac spine; disposing a guidewire at the target; advancing the guidewire from the target along the sacro-iliac joint on an iliac side of the sacro-iliac joint and into the sacrum along a selected trajectory; confirming the selected trajectory with medical imaging; removing the guidewire from the pathway; creating a pathway along the selected trajectory with a reamer from a posterior approach to the body, the pathway extending from at least the target through the cortical layers of the ilium and the first cortical layer of the sacrum; disposing bone graft adjacent the pathway between the ilium and the sacrum; and delivering a screw, which extends between a leading end and a trailing end including a head having a planar surface, along the pathway such that the screw extends through the second cortical layer of the ilium and the first cortical layer of the sacrum and is disposed for fixation with the ilium and the sacrum, wherein the planar surface is disposed in substantially flush alignment with an outer surface of the ilium.
The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
The exemplary embodiments of the surgical system and methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and method for treating the sacro-iliac (SI) joint. It is envisioned that the surgical system and methods of use disclosed provide stability and maintains structural integrity while reducing stress on the SI joint. It is further envisioned that the present disclosure may be employed to treat musculoskeletal disorders including SI dysfunction or syndrome, dehydration, destabilization and/or laxity.
In one embodiment, a method and system are provided for treating the SI joint. In one embodiment, the method and system include identifying the posterior superior iliac spine on a patient that is positioned in a prone position on an operating table. The posterior superior iliac spine is used as a landmark for making an incision. It is contemplated that identification of the posterior superior iliac spine limits vascular and muscular disruption from a surgical approach. A trajectory path is established using fluoroscopy and a guide wire is inserted into the posterior superior iliac spine, for example, on an iliac side of a SI joint. The guide wire is advanced across the SI joint into the sacrum. Upon breaching the sacral side of the SI joint, the advancement of the guidewire is stopped.
In one embodiment, the trajectory is confirmed by confirming guidewire placement with medical imaging, such as, for example, fluoroscopy. In one embodiment, the guide wire is passed through the ilium, into the first cortical margin of the sacrum and through the SI joint. It is envisioned that neural structures that exit the posterior of the sacrum are avoided. In one embodiment, a guide tube is placed over the guidewire according to the trajectory path of the guidewire above the posterior superior iliac spine of the patient. In one embodiment, the guide wire is removed. A reamer can be inserted over the guidewire or inserted over the guide tube. A surgical pathway is reamed through the ilium, across the SI joint and through the first cortical margin of the sacrum. In one embodiment, the reamer prepares an implant space along the trajectory path determined with the guidewire. In one embodiment, placement is confirmed with medical imaging.
In one embodiment, bone graft material, such as, for example, autograft and/or allograft is inserted into the SI joint space to create a bony contact between the iliac and sacrum sides. In one embodiment, the bone graft material is inserted into a cannula of a screw.
In one embodiment, a SI fixation screw is attached to a driver. A downward force is applied and the screw is driven through the ilium, through the graft material and into the sacrum following the path created by the reamer until the screw is flush with the ilium and docked into the sacrum. In one embodiment, screw placement is confirmed with fluoroscopy and the incision is closed.
In one embodiment, a method is provided for screw removal from the SI joint fusion. In one embodiment, the method includes providing an implant inserter configured to attach to the screw. The iliac side of the SI joint of a patient who underwent a SI fusion procedure is exposed. In one embodiment, a tube can be placed over the incision site. The dorsal aspect of the screw is positively identified. In one embodiment, the dorsal aspect of the screw is identified by fluoroscopy. The implant inserter is re-attached to the dorsal end of the screw and the screw is removed.
It is contemplated that one or all of the components of the surgical system may be disposable, peel-pack, pre-packed sterile devices. One or all of the components of the system may be reusable. The system may be configured as a kit with multiple sized and configured components.
It is envisioned that the present disclosure may be employed to treat spinal disorders that may include, but are not limited to, sacro-iliac joint disruptions, degenerative sacroilitis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. It is contemplated that the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. It is further contemplated that the disclosed system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column. The system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.
The present disclosure may be understood more readily by reference to the following detailed description of the disclosure taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure. Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”.
Further, as used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. Also, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.
The following discussion includes a description of a surgical system and method in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to
The components of system 30 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone material, tissue and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of system 30, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of system 30 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of system 30, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of system 30 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
System 30 includes an orthopedic implant, such as, for example, a screw 32, as shown in
Screw 32 includes a leading end 34, which is tapered. It is contemplated that end 34 is tapered, for example, with a bevel for easier insertion and less tearing of the tissue, such as the cortical layers of the ilium and the sacrum. Screw 32 includes a trailing end 36, as shown in
Screw 32 includes a diameter d1 adjacent end 36. It is envisioned that diameter d1 can vary in size from about 3.5 mm to about 7.00 mm. End 34 is tapered to a diameter d2 in a configuration to facilitate penetration with tissue. It is envisioned that diameter d2 can vary in size from about 2.8 mm to about 5.7 mm. Screw 32 includes a socket 40 at end 36. Socket 40 is hexagonal. Socket 40 is configured to accommodate a driver (not shown), which attaches to screw 32 so that screw 32 can be driven into an implant space prepared by a medical device, such as for example, a reamer, as described herein.
Screw 32 includes a major diameter d3, as shown in
System 30 includes an orthopedic implant, such as, for example, bone graft 46. Graft 46 is configured for disposal and engagement on or about the surfaces of screw 32 and/or anatomical surfaces of a body. It is envisioned that graft 46 may be configured as and/or include one or a plurality of a fastener, screw, cage, spinal rod and/or connector. It is further envisioned that graft 46 may be variously configured including cylindrical, rectangular, oval, uniform, non-uniform, mesh, staggered and/or undulating. In one embodiment, graft 46 includes an agent, which may be disposed, packed or layered within, on or about the surfaces of an implant, such as, screw 32 and/or a selected portion of an anatomy.
It is envisioned that the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae V. Osteogenic material may be included in the agent such as, for example, autologous bone harvested from the patient receiving the implant device, bone allograft, bone xenograft, any number of non-bone implants (for example ceramic, metallic, polymer), bone morphogenic protein, and/or bio-resorbable compositions. For example, the osteogenic material may comprise minerals such as calcium phosphate or calcium sulfate minerals, bone, including xenograft, allograft or autograft bone. The osteogenic material may also comprise demineralized bone matrix (DBM), osteoinductive factors such as bone morphogenetic proteins (for example human BMP-2 or human BMP-7 or heterodimers thereof) whether recombinantly produced or purified from tissues, LIM mineralization proteins (LMPs), or the like. The osteogenic material may also comprise a binder material such as blood, clottable blood fractions, platelet gel, collagen, gelatin, carboxymethyl cellulose, or other similar materials that will serve to bind together harder particles or materials such as mineral particles (for example bone or synthetic mineral particles) so as to create a three-dimensionally stable mass when compacted into the cavities of the implant device.
Graft 46 can contain other bioactive agents or other active agents, which may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, into the SI joint to treat, for example, pain, inflammation and degeneration. The agents may include pharmacological agents, such as, for example, antibiotics, pain medications, analgesics, anesthetics, anti-inflammatory drugs including but not limited to steroids, anti-viral and anti-retroviral compounds, therapeutic proteins or peptides, therapeutic nucleic acids (as naked plasmid or a component of an integrating or non-integrating gene therapy vector system), and combinations thereof.
The agent may also include analgesics or anesthetics such as acetic acid derivatives, clonidine, COX-2 selective inhibitors, COX-2 inhibitors, enolic acid derivatives, propionic acid derivatives, salicylic acid derivatives, opioids, opioid/nonopioid combination products, adjuvant analgesics, and general and regional/local anesthetics.
The agent may also include antibiotics such as, for example, amoxicillin, beta-lactamases, aminoglycosides, beta-lactam (glycopeptide), clindamycin, chloramphenicol, cephalosporins, ciprofloxacin, erythromycin, fluoroquinolones, macrolides, metronidazole, penicillins, quinolones, rapamycin, rifampin, streptomycin, sulfonamide, tetracyclines, trimethoprim, trimethoprim-sulfamthoxazole, and vancomycin.
The active agent may also include immunosuppressives agents, such as, for example, steroids, cyclosporine, cyclosporine analogs, cyclophosphamide, methylprednisone, prednisone, azathioprine, FK-506, 15-deoxyspergualin, prednisolone, methotrexate, thalidomide, methoxsalen, rapamycin, leflunomide, mizoribine (bredinin™), brequinar, deoxyspergualin, and azaspirane (SKF 105685), Orthoclone OKT.™ 3 (muromonab-CD3). Sandimmune™, Neoral™, Sangdya™ (cyclosporine), Prograf™ (FK506, tacrolimus), Cellcept™ (mycophenolate motefil, of which the active metabolite is mycophenolic acid), Imuran™ (azathioprine), glucocorticosteroids, adrenocortical steroids such as Deltasone™ (prednisone) and Hydeltrasol™ (prednisolone), Folex™ and Mexate™ (methotrxate), Oxsoralen-Ultra™ (methoxsalen) and Rapamune™ (sirolimus).
System 30 may include radiomarkers for identification of one or more of the components of system 30 under x-ray, fluoroscopy, CT or other medical imaging techniques. Metallic or ceramic radiomarkers, such as tantalum beads, tantalum pins, titanium pins, titanium endcaps and platinum wires can be used.
In assembly, operation and use, system 30, similar to that described, is employed with a surgical procedure for treatment of a SI joint J of a patient. System 30 may also be employed with other surgical procedures. For example, system 30 is employed with a surgical arthrodesis procedure, such as, for example, fusion for treatment of an applicable condition or injury of an affected SI joint J, as shown in
It is envisioned that system 30 may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery including percutaneous surgical implantation, whereby SI joint J is accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the target site is obtained, the particular surgical procedure is performed for treating the SI joint disorder. System 30 is then employed to augment the surgical treatment. System 30 can be delivered or implanted as a pre-assembled device or can be assembled in situ. System 30 may be completely or partially revised, removed or replaced in situ. It is contemplated that one or all of the components of system 30 can be delivered to the surgical site via manual manipulation and/or a free hand technique.
In use, to treat the affected section of SI joint J, the body of a patient is disposed in a prone position on a surface, such as, for example, a surgical table (not shown). A target P of a posterior superior iliac spine (PSIS) of the body is identified, as shown in
The body defines a vertical axis V extending from target P. A selected trajectory, such as, for example, a PSIS trajectory t is disposed along a transverse axis T relative to axis V to define a surgical pathway E (
A guidewire, such as, for example, a K-wire 50 is introduced at target P, as shown in
K-wire 50 advancement is stopped after breaching the first cortical layer of sacrum S. In one embodiment, K-wire 50 is advanced through the first cortical layer of sacrum S only. It is envisioned that K-wire 50 may extend in the cancellous bone of sacrum S. It is further envisioned that this configured avoids neural structures disposed adjacent posterior of sacrum S. In one embodiment, a selected trajectory, such as, for example, a PSIS trajectory is disposed approximately 15 degrees lateral or vertical relative to vertical axis V. In one embodiment, trajectory t and/or surgical pathway E is confirmed with medical imaging. In one embodiment, trajectory t and/or surgical pathway E is confirmed with C-arm or O-arm fluoroscopy.
It is envisioned that trajectory t and/or surgical pathway E may be confirmed with alternative imaging modality or image-less based application. For example, it is contemplated that medical imaging in accordance with the present disclosure may include isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography, multi-slice computed tomography, magnetic resonance imaging, high frequency ultrasound, optical coherence tomography, intra-vascular ultrasound, 2D, 3D or 4D ultrasound, intraoperative CT, MRI, or O-arms having single or multi flat panels receivers that move about the ring to acquire fluoroscopic images may also be used to acquire pre-operative or real-time images or image data of the trajectory of various elements utilized in the fusion procedure described herein. It is further contemplated that image datasets from hybrid modalities, such as positron emission tomography combined with CT, or single photon emission computer tomography combined with CT, could also provide functional image data superimposed onto anatomical data to be used to confidently reach target sights within the areas of interest.
In one embodiment, K-wire 50 is removed from surgical pathway E. Pathway E is further defined along trajectory t with a reamer 54 from a posterior approach to the body. Pathway E is enlarged via reamer 54 from target P, through the cortical layers and the cancellous bone of ilium I into SI joint J and into the first cortical layer of sacrum S, as shown in
Graft 46 is introduced and/or delivered along pathway E to adjacent the surgical site and into the SI joint. Graft 46 may be disposed, packed and/or layered about the surfaces of ilium I and sacrum S. Graft 46 facilitates a bony contact between ilium I and sacrum S. In one embodiment, fusion may be facilitated or augmented by introducing or positioning graft 46 within cavities of an implant.
Screw 32 is introduced and/or delivered along pathway E to adjacent the surgical site and into the SI joint via a driver (not shown). A downward force, in the direction shown by arrow A in
In one embodiment, a method is provided for the removal of screw 32. The body of a patient is disposed in a prone position on a surgical table. A target of a PSIS of the body is identified. A dorsal aspect of screw 32 is identified. In one embodiment, medical imaging is employed to confirm the identification of the dorsal aspect. A medical practitioner obtains access to a target including SI joint J, similar to that described above, in any appropriate manner, such as through incision and retraction of tissues. An implant inserter (not shown) is provided that is configured for attachment to screw 32. The iliac side of the sacro-iliac joint of the patient is exposed and the incision site is reopened. End 36 of screw 32 is identified. The implant inserter is attached to end 36. Screw 32 is removed and the incision site is closed.
In one embodiment, similar to the system and methods described above, a method for SI fusion is provided. The patient is positioned in a prone position. The PSIS is identified and an incision path is created. A trajectory is established with a guidewire and fluoroscopy is used to confirm trajectory. A working channel is placed over a guide wire. The guide wire is removed from the working channel. A reamer is inserted through the working channel along the trajectory path. The trajectory is confirmed with an imaging technique. Bone growth material is inserted into the SI joint. A cannulated screw is driven into the implant space. Positioning of the screw is verified with an imaging technique and the incision is closed.
In one embodiment, as shown in
Screw 132 includes a uniform major diameter D1, as shown in
Screw 132 includes a socket 140 at end 136. Socket 140 is hexagonal. Socket 140 is configured to accommodate a driver (not shown), which attaches to screw 132 so that screw 132 can be driven in an implant space prepared by a medical device, such as, for example, a reamer, as described herein.
Screw 132 defines a hollow central cavity, such as, for example, cannulated portion 142. Screw 132 includes uniform threads 144, as shown in
Screw 132 includes at least one or more fenestrations, such as, for example, openings 148. Openings 148 are configured to communicate with cannulated portion 142 and are configured to disperse flowable materials, such as, for example, biologics, agents, medical adhesives, bonding cements and/or bone healing substances, similar to those described herein. In one embodiment, openings 148 are formed in close proximity to end 134. In one embodiment, openings 148 are formed in close proximity to end 136, as shown in
It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
