US 201200 1 6420Al (19) United States (12) Patent Application Publication (10) Pub. N0.: US 2012/0016420 A1 NARAGHI (43) Pub. Date: Jan. 19, 2012

(54) DEVICES, SYSTEMS, AND METHODS FOR (52) US. Cl...... 606/250; 606/279 INTER-TRANSVERSE PROCESS DYNAMIC STABILIZATION (57) ABSTRACT Systems and methods are positioned between left and right (76) Inventor: FRED F‘ NARAGHI’ San transverse processes of adjacent vertebrae in a spine to pro Franclsco’ CA (Us) vide dynamic inter-transverse process distraction and stabi liZation and indirect expansion of both anterior and posterior (21) Appl' NO‘: 13/091’600 spaces of the spine. The systems and methods employ a left _ support component siZed and con?gured to be mounted (22) Flled: Apr‘ 21’ 2011 between the left transverse processes of the adjacent verte _ _ brae and a right support component and con?gured to be Related U‘s‘ Apphcatlon Data mounted betWeen the right transverse processes of the adja (60) Provisional application No. 61/399,585, ?led on Jul. Cent Venebrae- The left and right SUPPOYt Components exert a 14, 2010 dynamic separation force betWeen the left and right trans verse processes generally longitudinally along the spine to _ _ _ _ distract and stabilize space betWeen the adjacent inferior and Pubhcatlon Classl?catlon superior vertebrae and indirectly expand both anterior and (51) Int, Cl, posterior spaces of the spine. The systems and methods A61B 17/70 (200601) relieve pain associated With, e. g. disc herniation, disc degen A61B 17/88 (200601) eration, facet arthropathy, and .

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DEVICES, SYSTEMS, AND METHODS FOR spinal stenosis results in loW as Well as pain or INTER-TRANSVERSE PROCESS DYNAMIC abnormal sensations in the legs, , feet or , or STABILIZATION loss of bladder and boWel control. [0009] Disc herniation and spinal stenosis can sometimes RELATED APPLICATION be treated Without surgery, e.g., through the use of medica tions, steroid injections, rest or restricted activity, or physical [0001] This application claims the bene?t of US. Provi therapy. sional Patent Application Ser. No. 61/399,585, ?led 14 Jul. [0010] In cases When non-surgical treatments are not effec 2010, and entitled “Devices, Systems, and Methods for Inter tive, surgical treatments can be performed. spine Transverse Process Dynamic Stabilization,” Which is incor surgeries are performed for treatment of disc herniation and porated herein by reference. spinal stenosis on several hundred thousand patients each year to alleviate back pain and leg pain. The traditional treat FIELD OF THE INVENTION ments for disc herniation and stenosis to alleviate pain symp [0002] The invention generally relates to devices, systems toms have involved and decompression Which and methods for treating conditions of the spine, and, in usually involve removing bone from lamina partially (lami particular, systems and methods for distending the spine for notomy), or completely (), and removal of the treating, e.g., disc herniation and spinal stenosis. herniated disc portion. [0011] If there is a structural instability, typically the treat BACKGROUND OF THE INVENTION ment Would also include fusion. Fusion consists of applica tion of bone or cage implants either in the interbody space or [0003] The spine is made up of bones (vertebrae) cushioned to the posterolateral portions of vertebral bodies With or With by intervertebral discs. The intervertebral discs are respon sible for the attachment of vertebral bodies to each other, out application of pedicle screW instrumentation, to stabiliZe the vertebrae and alloW for fusion to occur to treat the insta providing ?exibility and load-sharing for the spinal column. bility. An consists of a tough outer layer (annu [0012] Recent studies have questioned the effectiveness of lus) and a soft inner layer (nucleus). discectomy, suggesting that discectomy may at best only [0004] With aging, a disc can undergo signi?cant changes offer a modest short-term bene?t in patients With due in volume and shape as Well as in biochemical composition to disc extrusion. According to these recent studies discec and biomechanical properties. The disc can become herni ated, Which is sometimes colloquially called a “slipped” disc tomy does not appear to provide a different outcome than non-surgical treatment. The advantage of discectomy is a or a “ruptured” disc. Other terms that are closely related include disc protrusion, bulging disc, pinched nerve, sciatica, more rapid resolution of the radicular leg symptoms. HoW ever, the disadvantages are numerous, including scar tissue, disc disease, disc degeneration, degenerative disc disease, instability requiring further surgeries, nerve , acceler and black disc. ated disc degeneration. e.g., decompressive laminectomy, [0005] When a herniated disk occurs, a small portion of the , foraminotomy, cervical discectomy and fusion, nucleus pushes out through a tear in the annulus into the spinal canal. The annulus tears usually at the back of the disc, cervical corpectomy, and laminoplasty. Which is right next to the nerves of the spine. The nucleus SUMMARY OF THE INVENTION starts to shift into the torn area, Which causes a bulge. The bulge applies pressure to the nerve. The bulge can irritate a [0013] The invention provides devices, systems, and meth nerve and result in pain, numbness or Weakness in the back, as ods for treating back pain and leg pain by dynamic stabiliZa Well as in a leg or an arm. Disc herniation can cause back pain tion of transverse processes of adjacent vertebrae (either uni and or leg pain via compression of nerve roots. Pain can also laterally left or right, or bilaterally left and right), optionally occur due to the nucleus material causing chemical irritation With ?xation. More particularly, the invention pro of adj acent neural pathWays such as nerve roots, dura, and the vides devices, systems, and methods for distraction of the posterior longitudinal ligament. space betWeen the transverse processes of spinal column [0006] Disc herniation can occur in any disc in the spine, (either unilaterally left or right, or bilaterally left and right), but the tWo most common forms are lumbar disc herniation optionally With facet joint ?xation. and cervical disc herniation. The former is the most common, [0014] The devices, systems, and methods that embody the causing loWer back pain (lumbago) and often leg pain (sci technical features of the invention indirectly increase the area atica) as Well. Within the spinal canal, as Well as the disc space, thereby [0007] The most common levels for a herniated disc are providing an indirect front and back decompression of spinal L4-5 and L5-Sl. The onset of symptoms is characterized by a canal and disc space. As a result, the devices, systems, and sharp, burning, stabbing pain radiating doWn the posterior or methods that embody the technical features of the invention lateral aspect of the leg, to beloW the knee. Pain is generally can relieve the back and/ or leg pain associated With impinge super?cial and localiZed, and is often associated With numb ment of the nerves due to disc herniation, disc degeneration, ness or tingling. In more advanced cases, motor de?cit, , post-laminectomy syndrome, and spinal stenosis. diminished re?exes or Weakness may occur. The devices, systems, and methods that embody the technical [0008] Spinal degeneration can also cause a medical con features of the invention can provide a balanced distraction dition called spinal stenosis, in Which the spinal canal nar for both posterior and anterior portions of the spinal column, roWs and compresses the spinal cord and nerves. Spinal steno Without causing . The devices, systems, and methods sis can be caused by , osteoporosis, a that embody the technical features of the invention can tumor, or a congenital condition. Spinal stenosis may affect optionally provide balanced facet joint ?xation in tandem the cervical, thoracic or lumbar spine. In some cases, it may With balanced distraction for both posterior and anterior por be present in all three places in the same patient. Lumbar tions of the spinal column. The methods that embody the