Patent Application
20110098817
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 a tubular implant configured for disposal with the SI joint. 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 elongated body. The body defines an outer surface. The outer surface is configured to engage an 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 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 tubular body, an outer surface of the tubular body and/or an inner core 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 tubular body and the inner core 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 an elongated body 22 that defines an outer surface 24. Body 22 extends from a first end 26 to a second end 28 along a longitudinal axis a. 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 solid or tubular, as will be described.
Body 22 has a cylindrical 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 2-25 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 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 fusion procedure for treatment of a condition or injury, such as degeneration or fracture, 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 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. 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. Sacro-iliac implant 20 is disposed with sacro-iliac joint J for treating the sacro-iliac joint disorder. It is envisioned that body 22 may be inserted via a trajectory oriented from an anterior, posterior, superior or inferior direction.
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.
In one embodiment, as shown in
In one embodiment, as shown in
In one embodiment, as shown in
Referring to
Sacro-iliac implant 120 includes an elongated tubular body 122, similar to body 22 discussed above, which defines an outer surface 124. Body 122 extends from a first end 126 to a second end 128 along a longitudinal axis a.
Outer surface 124 is configured to engage an articular surface A of a sacro-iliac joint J along a plane P (shown in
Body 122 defines an elongated cavity 132 configured for disposal of an inner core 134. It is contemplated that body 122 is configured as a hollow rod that can be over-molded or slip fit on to inner core 134. It is further contemplated that sacro-iliac implant 120 can provide dual stiffness to the implant system. For example, body 122 includes a first material, which is soft or flexible. Such flexible materials can include polyurethane and silicone based materials, foam, as well other flexible materials discussed herein. Inner core 134 is a rigid rod, which includes a rigid material, such as metals, rigid polymers and ceramics, as well other rigid materials discussed herein. It is envisioned that body 122 and inner core 134 may be formed from the same material, different materials or composites thereof. Body 122 may also be formed of semi-rigid and rigid materials, and inner core 134 may be formed of flexible or semi-rigid materials. Body 122 may be monolithically formed.
Depending on the flexibility or stiffness of body 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 promote fusion of the elements of sacro-iliac joint J.
Second end 128 has a tapered nose portion 136. Nose portion 136 facilitates impaction of sacro-iliac implant 120 within sacro-iliac joint J. It is contemplated that the configuration of nose portion 136 facilitates percutaneous access with sacro-iliac joint J.
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 (as described with regard to
It is further envisioned that body 122 has a tubular and hollow configuration such that insertion tool 140 temporarily functions as an inner core for body 122 during insertion of sacro-iliac implant 120 with sacro-iliac joint J. In such a configuration, insertion tool 140 is removed such that body 122 is positioned for placement. Body 122 can be implanted and maintain rigidity or flatten under pressure.
Sacro-iliac implant 120 is disposed with sacro-iliac joint J for treating the sacro-iliac joint disorder. In one example, a procedure for implanting sacro-iliac implant 120 includes impaction of sacro-iliac implant 120 along plane P into joint space JS. The selected trajectory T and/or manipulation of body 122 after implantation can optimize positioning and/or placement of sacro-iliac implant 120. Manipulation can include pushing, pulling, rotation of sacro-iliac implant 120 about longitudinal axis a and/or rotation of sacro-iliac implant 120 about the joint axis once implanted. Fixation of sacro-iliac implant 120 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. It is contemplated that the implant system including sacro-iliac implant 120 may be employed during arthoplasty.
Locking part 130 engages a face or profile of articular surface A to facilitate fixation of body 122 with sacro-iliac joint J during an arthrodesis treatment. Locking part 130 may include a flange, hook, hole, or void for primary fixation. It is contemplated that locking part 130 may include a secondary locking part for fixation such as screws and/or nails. It is further contemplated that locking part 130 can engage a face or profile of articular surface A, such as, for example, a crest portion of a surface of sacro-iliac joint J and/or an end component of joint space JS, for example to hook onto an end portion of ilium I. It is envisioned that in joint fusion applications of sacro-iliac implant 120, body 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 envisioned that body 122 may be inserted via a trajectory oriented from an anterior, posterior, superior or inferior direction. A portion or substantially all of outer surface 124 may be threaded for fixation of body 122 with articular surface A. Sacro-iliac implant 120 may be inserted parallel and/or in-line with plane P.
In one embodiment, as shown in
In one embodiment, as shown in
In one embodiment, as shown in
Second body 430 extends from a first end 432 to a second end 434 and includes a nose portion 436. Second body 430 may include an inner core, similar to those described above. First body 422 has a greater length relative to second body 430. During a surgical treatment of a disorder, similar to those described above, first body 422 is inserted along a channel C reamed along plane P (
It is contemplated that first body 422 and second body 430 are employed to optimize the distance that sacro-iliac joint J can be spaced apart. This distance can be preselected. First body 422 and second body 430 can be inserted with sacro-iliac joint J through the same trajectory and pivoted from the other body. One or a plurality of pivoting bodies may be employed with first body 422. It is envisioned that a reamer or tapping device can be used to create a channel in articular surface A for receiving one or a plurality of tubular bodies. It is further envisioned that a guide wire system may be used to deliver the components of the implant system.
Referring to
Outer surface 524 is configured to engage an articular surface A of a sacro-iliac joint J along a plane P, similar to that described above. Body 522 defines an elongated cavity 532. Body 522 includes a first elongated portion 534 defining an inner surface 536 and a second elongated portion 538 defining an inner surface 540 pivotally connected to first portion 534 adjacent first end 526. Inner surface 536 is concave and arcuate in a configuration for receiving inner surface 540, which has a convex configuration. Body 522 includes a pin 542 that connects first portion 534 with second portion 538 to facilitate pivotal connection therebetween.
Body 522 is disposable in a first orientation (
In assembly, operation and use, the implant system including sacro-iliac implant 520 is employed with a surgical fusion procedure for treatment of a condition or injury of sacro-iliac joint J, similar to that described with regard to
A trajectory T (as described with regard to
In the second orientation, first portion 534 is disposed at an angle α from second portion 538. It is contemplated that angle α is disposed at a preselected angle α, which may be in a range of approximately 180 degrees to 90 degrees. It is further contemplated that angle α may be in a range of approximately 0-180 degrees. Outer surface 524 of body 522 engages articular surface A along plane P. Sacro-iliac implant 520 is disposed with sacro-iliac joint J for treating the sacro-iliac joint disorder. Manipulation of first portion 534 and second portion 538 to a spaced apart orientation, disposed at angle α, facilitates coverage of substantially the entire sacro-iliac joint J and spacing apart of the articular surfaces A.
Body 522 may include a locking part for fixing sacro-iliac implant 520 with articular surface A, similar to those described above. It is envisioned that body 522 may be inserted via a trajectory oriented from an anterior, posterior, superior or inferior direction.
In one embodiment, the implant system may be employed during an arthroplasty procedure. For example, 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.
