Patent Application
20110098816
The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to an implant system and method for treating the sacro-iliac joint.
The sacroiliac (SI) joint is a diarthrodial joint that joins the sacrum to the ilium bones of the pelvis. In the SI 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 SI joints at the juncture of the sacrum and ilia. Stress placed on the SI joints in an upright position of the body makes the lower back susceptible to injury.
Disorders of the SI joint can cause low back and radiating buttock and leg pain in patients suffering from degeneration and laxity of the SI joint. In some cases, the SI joint can undergo dehydration and destabilization, similar to other cartilaginous joints, which causes significant pain. The SI joint is also susceptible to trauma and degeneration, from fracture and instability. It is estimated that disorders of the SI 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 include stabilization and/or arthrodesis. Stabilization can include the use of bone screws that are directly threaded into bone. Arthrodesis may include fusion devices to immobilize a joint. The present disclosure describes an improvement over these prior art technologies.
Accordingly, an implant system and method is provided for treating the SI joint. It is contemplated that the system may include an implant configured as a SI joint spacer. It is further contemplated that the implant system and method may be employed for arthrodesis and/or arthroplasty treatment.
In one particular embodiment, in accordance with the principles of the present disclosure, an orthopedic implant is provided. The orthopedic implant includes at least one circular body. The at least one circular body defining an outer surface configured to engage at least one articular surface of a sacro-iliac joint along a plane substantially parallel to the articular surface.
The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
Like reference numerals indicate similar parts throughout the figures.
The exemplary embodiments of the implant 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 an implant system and method for treating the SI joint. It is envisioned that the implant 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 sacro-Iliac dysfunction or syndrome, dehydration, destabilization, laxity, fracture, tumor, spinal disorders and other orthopedic disorders. It is contemplated that the present disclosure may be employed with surgical treatments, including open surgery, percutaneous and minimally invasive procedures of such disorders, such as, for example, arthrodesis including fusion, arthroplasty to maintain motion, bone graft and implantable prosthetics. It is further contemplated that the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. The disclosed implant system and methods may be employed in a surgical treatment with a patient in a prone or supine position, employing a posterior, lateral, inferior, posterior-inferior, superior or anterior approach. The present disclosure may be employed with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention 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 invention. 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”.
The following discussion includes a description of an implant system, related components and exemplary methods of employing the implant system 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 the implant system are fabricated from materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone, biocompatible materials and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, components of the implant system, such as, for example, a circular body, an outer surface of the circular body and/or portions thereof, discussed below, can be fabricated from materials such as commercially pure titanium, titanium alloys, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon fiber reinforced PEEK composites, PEEK-BaSO4 composites, ceramics and composites thereof, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, polyurethanes of any durometer, epoxy, silicone, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors. Different components of the implant system may have alternative material composites to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference.
It is envisioned that the components of the implant system can be manufactured via various methods. For example, the circular body can be manufactured and assembled via injection-molding, insert-molding, overmolding, compression molding, transfer molding, co-extrusion, pultrusion, dip-coating, spray-coating, powder-coating, porous-coating, milling from a solid stock material, and their combinations. One skilled in the art, however, will realize that such materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, would be appropriate.
The implant system includes an orthopedic implant, such as, for example, a sacro-iliac implant 20, which is configured, for example, to treat S-I joint disorders including those caused by degeneration or trauma. It is contemplated that sacro-iliac implant 20 may be employed for arthrodesis and/or arthroplasty applications, as will be described.
Sacro-iliac implant 20 includes a circular body, such as, for example, spherical body 22 that defines an outer surface 24. Outer surface 24 is configured to engage an articular surface A of a sacro-iliac joint J along a plane P. Plane P is substantially parallel to articular surface A. It is contemplated that articular surface A may refer to a sacral surface S1 of a sacrum S and/or an iliac surface I1 of an ilium I. Body 22 may be configured to engage opposing articular surfaces such as sacral surface S1 and iliac surface I1 and/or opposing valleys or peaks of an individual sacrum S or ilium I. Body 22 may have a ball, solid, hollow, porous or cage configuration. Outer surface 24 has a continuously even or smooth configuration. It is contemplated that outer surface 24 is configured to substantially match articular surface(s) A and may be substantially smooth, rough and/or polished. In one embodiment, as shown in
Body 22 has a circular cross section and has a diameter d, according to the requirements of the particular application. It is envisioned that diameter d may be in a range of 0.5-5.0 millimeters (mm). It is contemplated that the cross-sectional geometry of body 22 may have various configurations, for example, round, oval, rectangular, polygonal, irregular, uniform, non-uniform, consistent or variable.
It is envisioned that body 22 can be variously configured and dimensioned with regard to size, shape, thickness, geometry and material. Body 22 may also be formed of one or a plurality of elements such as spaced apart portions, staggered patterns and mesh. It is envisioned that the particular geometry and material parameters of body 22 may be selected to modulate the flexibility or stiffness of sacro-iliac implant 20, such as those examples discussed herein. For example, body 22 can be configured to have varying ranges or degrees of flexibility or stiffness such as rigid, compliant, or reinforced. Depending on the flexibility or stiffness of body 22, the flexibility or stiffness of sacro-iliac implant 20 can be contoured according to the requirements of a particular application. It is contemplated that the ability to vary stiffness of sacro-iliac implant 20 provides restoration of kinematic function of joint J or promote fusion of the elements of joint J. It is envisioned that the components of sacro-iliac implant 20 may be monolithically formed, integrally connected or arranged with attaching elements.
In one embodiment, as shown in
In assembly, operation and use, the implant system including sacro-iliac implant 20 is employed with a surgical procedure for treatment of a sacro-iliac joint of a patient, as discussed herein. The implant system may also be employed with other surgical procedures. In particular, the implant system is employed with a surgical arthroplasty procedure for treatment of an applicable condition or injury of an affected sacro-iliac joint J, as shown in
In use, to treat the affected section of sacro-iliac joint J, a medical practitioner obtains access to a surgical site including sacro-iliac joint J in any appropriate manner, such as through incision and retraction of tissues. It is envisioned that the implant system may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby sacro-iliac joint J is accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure is performed for treating the sacro-iliac joint disorder. The implant system is then employed to augment the surgical treatment. The implant system can be delivered or implanted as a pre-assembled device or can be assembled in situ. The implant system may be completely or partially revised, removed or replaced in situ.
A trajectory T is defined for insertion and/or injection of sacro-iliac implant 20 within sacro-iliac joint J. Trajectory T is determined by defining an orientation that is substantially parallel to plane P defined by articular surface A of sacro-iliac joint J. Implant 20 is inserted via the protected passageway along the defined trajectory T into sacro-iliac joint J. A cavity of sacro-iliac joint J is prepared along trajectory T for disposal of sacro-iliac implant 20.
The protected passageway includes a dilator/delivery tube 30 configured to deliver sacro-iliac implant 20 directly to joint space JS of sacro-iliac joint J. It is envisioned that dilator/delivery tube 30 may be configured as an in-situ guidable instrument, and may include an endoscope camera tip for viewing insertion trajectory.
Sacro-iliac implant 20 is manipulated such that outer surface 24 of body 22 engages articular surface A substantially along plane P, according to the contour of articular surface A. Manipulation can include pushing, pulling, rotation of sacro-iliac implant 20, rotation of sacro-iliac implant 20 about the joint axis once implanted and/or by mechanical devices.
Sacro-iliac implant 20 is disposed with sacro-iliac joint J for treating the sacro-iliac joint disorder. Body 22 is configured for movable engagement with articular surfaces A in a plurality of directions. Bodies 22 roll along articular surface A allowing relative motion of the articular surfaces A of the sacrum and ilium of sacro-iliac joint J. The outer surfaces of bodies 22 may be compressible. It is envisioned that body 22 may be inserted via a trajectory oriented from a posterior, lateral, inferior, posterior-inferior, superior or anterior direction.
It is contemplated that the implant system including sacro-iliac implant 20 may be employed during a surgical fusion procedure for treatment of a condition or injury, such as, degeneration or fracture. Fixation of sacro-iliac implant 20 with articular surface A and/or other portions of sacro-iliac joint J can be facilitated by the resistance provided by joint space JS and/or engagement with the outer articular structures. Sacro-iliac implant 20 may include locking structure to facilitate fixation with articular surface(s) A. It is envisioned that such locking structure may include fastening elements such as, for example, clips, hooks, adhesives and/or flanges, as will be described below. It is further envisioned that in joint fusion applications of sacro-iliac implant 20, body 22 includes voids, cavities and/or openings for including bone growth promoting material, such as those described herein, which can be packed or otherwise disposed therein.
It is envisioned that implant system can be used with various bone screws to enhance fixation. It is contemplated that the implant system and any screws and attachments may be coated with an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenic protein for enhanced bony fixation to facilitate motion of the treated area. Sacro-iliac implant 20 can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques.
Referring to
Sacro-iliac implant 120 includes a circular body, such as, for example, a disc 122, similar to body 22 discussed above, which defines an outer surface 124. Outer surface 124 is configured to engage an articular surface A of a sacro-iliac joint J along a plane P (
Disc 122 has a periphery 126 that defines a thickness t of disc 122. It is envisioned that thickness t may be in a range of 0.5-5.0 mm. Periphery 126 has an arcuate configuration and is disposed about the perimeter of disc 122. It is envisioned that periphery 126 may have alternate cross section configurations such as elliptical, rectangular and polygonal. It is further envisioned that periphery 126 may define a substantially planar surface about the perimeter of disc 122.
Outer surface 124 includes a first lateral surface 128 and a second lateral surface 132. First lateral surface 128 opposes second lateral surface 132 about periphery 126. First lateral surface 128 defines a concave portion 134 and second lateral surface 132 defines an opposing concave portion 136. It is contemplated that only one of lateral surfaces 128, 132 may include a concave portion and/or may include alternate surface configurations. Lateral surfaces 128, 132 may each include one or a plurality of spaced apart concave portions. It is further contemplated that periphery 126 and/or lateral surfaces 128, 132 may include a concave, convex, planar, textured and/or perforated configuration. In one embodiment, as shown in
Depending on the flexibility or stiffness of disc 122, the flexibility or stiffness of sacro-iliac implant 120 can be configured according to the requirements of a particular application. It is contemplated that the ability to vary stiffness of sacro-iliac implant 120 provides restoration of kinematic function of sacro-iliac joint J or promotes fusion of the elements of sacro-iliac joint J.
In one embodiment, as shown in
In assembly, operation and use, the implant system including sacro-iliac implant 120 is employed with a surgical procedure for treatment of a sacro-iliac joint of a patient and may be employed with other surgical procedures. Referring to
A trajectory T is defined for insertion of sacro-iliac implant 120 within sacro-iliac joint J. Trajectory T is determined by defining an orientation that is substantially parallel to plane P defined by articular surface A of sacro-iliac joint J. In other embodiments, as shown in
Implant 120 is inserted with dilator/delivery tube 130 via a protected passageway along the defined trajectory T into sacro-iliac joint J. A cavity of sacro-iliac joint J is prepared along trajectory T for disposal of sacro-iliac implant 20. Disc 122 may also be delivered via a grasp inserter that engages sacro-iliac implant 120.
In one embodiment, as shown in
In one embodiment, as shown in
In one embodiment, as shown in
In one embodiment, as shown in
In one embodiment, as shown in
Referring to
Sacro-iliac implant 120 is manipulated such that outer surface 124 of body 122 engages articular surface A along plane P. Sacro-iliac implant 120 is disposed with sacro-iliac joint J for treating the sacro-iliac joint disorder. Sacro-iliac implant 120 may include locking structure to facilitate fixation with articular surface(s) A. It is envisioned that in joint fusion applications of sacro-iliac implant 120, disc 122 includes voids, cavities and/or openings for including bone promoting material, such as those described herein, which can be packed or otherwise disposed therein.
It is contemplated that the implant system including sacro-iliac implant 120 may be employed during arthoplasty. For example, disc 122 is configured for movable engagement with articular surfaces A. Discs 122 facilitate relative movement of articular surface(s) A allowing relative motion of the articular surfaces A of the sacrum and ilium of sacro-iliac joint J. The lateral surfaces of discs 122 may be compressible.
Referring to
Sacro-iliac implant 620 includes a circular body, such as, for example, a segmented disc 622, similar to disc 122 discussed above, which defines an outer surface 624. Outer surface 624 is configured to engage articular surface(s) A of sacro-iliac joint J along plane(s) P (
Outer surface 624 includes a first lateral surface 628 and a second lateral surface 632. First lateral surface 628 and second lateral surface 632, each have a substantially planar configuration. First lateral surface 628 opposes second lateral surface 632 about periphery 626. It is contemplated that periphery 626 and/or lateral surfaces 628, 632 may include a concave, convex, planar, textured and/or perforated configuration.
Disc 622 is an elastic body that includes a plurality of segments 623. The segments of disc 622 are connected and relatively movable, such that the circular shape of disc 622 is deformable. The segments of disc 622 are manipulated and deformed from the circular disc shape into a substantially straightened, non-relaxed configuration, as shown in
In assembly, operation and use, the implant system including sacro-iliac implant 620 is employed with a surgical procedure for treatment of a sacro-iliac joint of a patient and may be employed with other surgical procedures. It is contemplated that sacro-iliac implant 620 may be employed for arthrodesis and/or arthroplasty applications.
Dilator/delivery tube 630 is delivered with sacro-iliac implant 620 and the linear orientation of disc 622 disposed therein, via a protected passageway to joint space JS of sacro-iliac joint J. Disc 622 is unloaded from dilator/delivery tube 630 into joint space JS of sacro-iliac joint J. It is envisioned that disc 622 may have a segmented coil configuration that can be loaded into a large gauge needle and delivered to joint space JS. The protected passageway may include dilators.
As sacro-iliac implant 620 enters joint space JS, the segments of disc 622 are no longer subject to the restraint of tube 630 and deformation. The segments return to the unstressed, relaxed configuration such that folded segments 623 retain their disc shape, as shown in
Referring to
Sacro-iliac implant 720 includes a circular body, such as, for example, a coiled disc 722, similar to disc 122 discussed above, which defines an outer surface 724. Outer surface 724 is configured to engage articular surface(s) A of sacro-iliac joint J along plane(s) P (
Outer surface 724 includes a first lateral surface 728 and a second lateral surface 732. First lateral surface 728 and second lateral surface 732, each have a substantially corrugated configuration. First lateral surface 728 opposes second lateral surface 732 about periphery 726.
Disc 722 is an elastic body formed of an elastic coil having a first end 723 and a second end 725. Disc 722 is coiled such that the circular shape of disc 722 is deformable. The coil of disc 722 is manipulated and deformed from the circular disc shape into a substantially straightened, non-relaxed configuration, as shown in
In assembly, operation and use, the implant system including sacro-iliac implant 720 is employed with a surgical procedure for treatment of a sacro-iliac joint of a patient and may be employed with other surgical procedures. It is contemplated that sacro-iliac implant 720 may be employed for arthrodesis and/or arthroplasty applications.
Dilator/delivery tube 730 is delivered with sacro-iliac implant 720 and the linear orientation of disc 722 disposed therein, via a protected passageway to joint space JS of sacro-iliac joint J. Disc 722 is unloaded from dilator/delivery tube 730 into joint space JS of sacro-iliac joint J. As sacro-iliac implant 720 enters joint space JS, the coil of disc 722 are no longer subject to the restraint of tube 730 and deformation. The coil returns to the unstressed, relaxed configuration such that disc 722 retains its disc shape, 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.
