The present invention relates to a system and a method for an intervertebral implant assembly, and more particularly to the use of an intervertebral implant for decompression and fusion.
The human spine includes individual vertebras that are connected to each other. Under normal circumstances the structures that make up the spine function to protect the neural structures and to allow us to stand erect, bear axial loads, and be flexible for bending and rotation. However, disorders of the spine occur when one or more of these spine structures are abnormal. In these pathologic circumstances, surgery may be tried to restore the spine to normal, achieve stability, protect the neural structures, or to relief the patient of discomfort. The goal of spine surgery for a multitude of spinal disorders especially those causing compression of the neural structures is often decompression of the neural elements and/or fusion of adjacent vertebral segments. Fusion works well because it stops pain due to movement at the facet joints or intervertebral discs, holds the spine in place after correcting deformity, and prevents instability and or deformity of the spine after spine procedures such as discectomies, laminectomies or corpectomies. Discectomy and fusion are commonly performed in the cervical spine but there is increasing application in the thoracic and lumbar spine, as well.
Several spinal fixation systems exist for stabilizing the spine so that bony fusion is achieved. The majority of these fixation systems utilize fixation elements such as rods wires or plates that attach to screws threaded into the vertebral bodies, facets or the pedicles. In addition to stabilization of the vertebral elements with fixation elements, there is a need to maintain the decompression of the intervertebral discs where discectomies or microdiscectomies have been performed. Some of theses decompression methods include inserting an implant in the intervertebral space between two adjacent vertebras in order to maintain the desired axial distance from the superior and inferior vertebral wall. The intervertebral implant is usually made of a biocompatible material in the shape of a hollow block. The intervertebral implant may be inserted from the anterior, posterior, from a transforaminal approach, or medial/lateral approach. In other decompression methods, bone growth material such as bone graft, harvested bone, or dematerialized bone matrix are injected, inserted, or impacted into the disc space. This material fills the space remaining from the discectomy procedure and acts as a catalyst for bone growth and bone fusion within the disc space.
The use of stabilization rods in combination with the insertion of an intervertebral implant is effective in treating several spinal disorders. However, the operating procedure for attaching the rods and inserting the intervertebral implant is usually long. Accordingly, it is desirable to provide an intervertebral implant that offers both stabilization and decompression of adjacent vertebras.
The invention relates to a system and method for an intervertebral implant assembly that includes a U-shaped implant and a unique inserter, which attaches to the implant without the use of threads or screws through the implant. Once in the body, the implant acts as a spacer for intervertebral decompression and promotes vertebral fusion with the use of bone growth materials.
In general, in one aspect, the invention features an intervertebral implant assembly for stabilization and decompression of two adjacent spinal vertebras including an implant having a U-shaped body shaped and dimensioned to be placed between two adjacent vertebras. The U-shaped body comprises a rounded front end, an open back end, first and second elongated components extending from the rounded front end, forming the U-shaped body and ending at the open back end and at least one rigid strut extending from and connecting opposite inner side surfaces of the first and second elongated components. A first through-opening is formed in the space between the front end, the rigid strut and the opposite inner side surfaces of the front portions of the first and second elongated components and a second through-opening is formed in the space between the open back end, the rigid strut and the opposite inner side surfaces of the back portions of the first and second elongated components.
Implementations of this aspect of the invention may include one or more of the following features. First and second grooves are formed on the outer side surfaces of the back portions of the first and second elongated components. The first and second grooves start at the back end and terminate at the mid-section of the outer side surfaces of the first and second elongated components, respectively. The top and bottom surfaces of the U-shaped body comprise protrusions configured to grip into the bottom and top surfaces of the two adjacent vertebras, respectively. The top and bottom surfaces of the U-shaped body are inclined and taper from the back side toward the front side. The U-shaped body further comprises holes extending from the top surface to the bottom surface and pins dimensioned to fit within the holes. The pins comprise radio-opaque material and are used as position indicators during fluoroscopy. Bone growth material is inserted in the first and second through openings. The first and second elongated components comprise first and second extensions, extending from and being perpendicular to the back ends of the first and second elongated components, respectively. The first and second extensions protrude inward and do not converge together. The first extension comprises a first rectangular portion at the bottom, a rounded portion in the middle and a second rectangular portion at the top. The second rectangular portion is set outward at a plane parallel to the first rectangular portion. The second extension comprises a first rectangular portion at the top, a rounded portion in the middle and a second rectangular portion at the bottom. The second rectangular portion is set outward at a plane parallel to the first rectangular portion. The assembly further includes an inserter tool. The inserter tool comprises an elongated inner shaft comprising a flat disc at the distal end, a middle sleeve surrounding the elongated shaft and comprising an attachment jaw at its distal end and an L-shaped opening at its proximal end, and an outer sleeve surrounding the middle sleeve. The flat disc comprises first and second protrusions extending from the sides of the flat disc. The first and second protrusions are configured to be inserted in the open back end of the U-shaped body and to be placed behind the first and second extensions of the U-shaped body, respectively. The elongated inner shaft further comprises a pin at its proximal end. The pin is shaped and dimensioned to be inserted and rotated within the L-shaped opening of the middle sleeve. The elongated inner shaft further comprises a spring-loaded ball and the middle sleeve comprises first and second detent holes dimensioned to capture the spring loaded ball. The attachment jaw comprises first and second protrusions shaped and dimensioned to slide within the first and second grooves of the U-shaped body, respectively. The first and second protrusions comprise ridges on their inner surfaces. The outer sleeve comprises inner threads and the middle sleeve comprises outer threads. The outer sleeve inner threads are configured to engage the outer threads of the middle sleeve and thereby to move the outer sleeve partially over the attachment jaw and thereby to lock the first and second protrusions in place.
In general in another aspect the invention features an inserter tool including an elongated inner shaft comprising a flat disc at the distal end, a middle sleeve surrounding the elongated shaft and comprising an attachment jaw at its distal end and an L-shaped opening at its proximal end and an outer sleeve surrounding the middle sleeve. The elongated inner shaft further comprises a pin at its proximal end and the pin is shaped and dimensioned to be inserted and rotated within the L-shaped opening of the middle sleeve. The inserter tool is used for grasping and inserting an intervertebral implant.
Implementations of this aspect of the invention may include one or more of the following features. The elongated inner shaft further comprises a spring-loaded ball and the middle sleeve comprises first and second detent holes dimensioned to capture the spring loaded ball. The intervertebral implant comprises a U-shaped body shaped and dimensioned to be placed between two adjacent vertebras, and the U-shaped body comprises a rounded front end, an open back end, first and second elongated components extending from the rounded front end, forming the U-shaped body and ending at the open back end and at least one rigid strut extending from and connecting opposite inner side surfaces of the first and second elongated components. The flat disc comprises first and second protrusions extending from the sides of the flat disc and the first and second protrusions are configured to be inserted in the open back end of the U-shaped body of the intervertebral implant and to be placed behind the first and second extensions of the U-shaped body, respectively. The attachment jaw comprises first and second protrusions shaped and dimensioned to slide within first and second grooves of the U-shaped body, respectively. The first and second protrusions comprise ridges on their inner surfaces. The outer sleeve comprises inner threads and the middle sleeve comprises outer threads and the outer sleeve inner threads are configured to engage the outer threads of the middle sleeve and thereby to move the outer sleeve partially over the attachment jaw and thereby to lock the first and second protrusions in place.
In general in another aspect the invention features a method for stabilizing and decompressing two adjacent spinal vertebras, including inserting an implant between two adjacent vertebras. The implant comprises a U-shaped body having a rounded front end, an open back end, first and second elongated components extending from the rounded front end, forming the U-shaped body and ending at the open back end and at least one rigid strut extending from and connecting opposite inner side surfaces of the first and second elongated components. The implant further comprises a first through-opening formed in the space between the front end, the rigid strut and the opposite inner side surfaces of the front portions of the first and second elongated components, and a second through-opening formed in the space between the open back end, the rigid strut and the opposite inner side surfaces of the back portions of the first and second elongated components. The method also includes inserting bone growth material in the first and second through openings.
Among the advantages of this invention may be one or more of the following. The inserter attaches to the implant without the use of threads or screws through the implant. Once in the body, the implant acts as a spacer for intervertebral decompression and promotes vertebral fusion with the use of bone growth materials. Bone growth material can be inserted in the second through opening through the open back end after the implant has been inserted between the adjacent vertebras.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and description below. Other features, objects and advantages of the invention will be apparent from the following description of the preferred embodiments, the drawings and from the claims.
Referring to the figures, wherein like numerals represent like parts throughout the several views:
a shows a detailed view of the distal end of the middle sleeve of
b shows a detailed view of the proximal end of the middle sleeve of
a shows an axial view of a vertebra with the inserter tool and the implant in the implanted position; and
b shows an anterior view of two adjacent vertebras with the inserter tool and the implant in the implanted position.
Referring to
Referring to
Middle sleeve 130 includes attachment jaws 135 at its distal end and the above mentioned L-shaped opening 131 and detent holes 132a, 132b at the proximal end. The attachment jaws 135 include two opposite and equal protrusions 136a and 136b with ridges 137a and 137b on their inner surfaces. Protrusions 136a and 136b slide into grooves 108a, 108b formed in the outer sides of implant 100 and ridges 137a, 137b grip onto the outer side surfaces of implant 100. Pin 123 of the inner shaft 121 travels down the vertical channel 138a of the L-shaped opening and rests at the mid-corner 138b, while spring-loaded ball 124 is captured in detent hole 134a in the implant unlocked position 151. In the implant locked position 153, the pin 123 is turned and sits at the end 138c of the L-shaped opening 131 and the spring loaded ball 124 is captured in detent hole 134b. The L-shaped opening 131, detent-hole mechanism 132, disc 125 with protrusions 126a, 126b and extensions 111a, 111b of the implant 100 all work together to lock the implant 100 onto the inserter 120 and to prevent distal/proximal motion. There are also a series of threads 133 below the detent-hole mechanism 132, which interface with threads in the outer sleeve 140, as will be described below, and a series of oblong shaped holes 134 along the middle shaft 130.
The outer sleeve 140 includes a handle 141 at the proximal end, threads 142 on the inner surface at the proximal end, a series of oblong shaped holes 143 below the handle 141 on the shaft, and a chamfered cut 144 at the inner edge of the distal end of the sleeve.
Referring to
Several embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.
This application claims the benefit of U.S. provisional application Ser. No. 61/256,435 filed Oct. 30, 2009 and entitled “SYSTEM AND METHOD FOR MEDIAL/LATERAL LUMBAR FUSION”, the contents of which are expressly incorporated herein by reference.
Number | Date | Country | |
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61256435 | Oct 2009 | US |