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US 20070118133 A1 Abstract Systems for minimally invasive disc augmentation include an anulus augmentation component and a nucleus augmentation component. Both are suited for minimally invasive deployment. The nucleus augmentation component restores disc height and/or replaces missing nucleus pulposus. The anulus augmentation component shields weakened regions of the anulus fibrosis and/or resists escape of natural nucleus pulposus and/or the nucleus augmentation component. Methods and deployment devices are also disclosed. Methods of repairing a herniated disc by displacing at least a portion of the herniated segment to within the pre-herniated borders of the disc and anchoring at least a portion of the displaced herniated segment to a site within the disc are also provided.
Claims(33) 1. A method of treating an intervertebral disc comprising:
providing an implant delivery tool having a proximal end and a distal end, the distal end adapted to deliver a treatment device; providing a fixation tool having a proximal end and a distal end, the distal end adapted to deliver a fixation element; introducing the distal end of the implant delivery tool beyond at least a first outer layer of the anulus of an intervertebral disc deploying said implant in the intervertebral disc; introducing the distal end of said fixation tool beyond at least a first outer layer of the anulus; deploying at least one fixation device into, or through, the wall of an anulus and through the implant to hold said implant at least partially beyond a first outer layer of the anulus; removing said fixation tool; and removing said implant delivery tool. 2. The method of
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15. A fixation device useful for intervertebral disc reconstruction for treating a disc having a hole, defect, aperture, or weakenedportion in the wall of the anulus fibrosis of said intervertebral disc, said device comprising:
at least one anchor portion and at least one support member. 16. The device of
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19. A method of treating an intervertebral disc comprising:
providing a first delivery tool having a proximal end and a distal end, the distal end carrying a treatment device; providing at least one second delivery tool having a proximal end and a distal end, the distal end carrying a fixation element; introducing the distal end of the first delivery tool at least partially into subannular intervertebral disc space; deploying said treatment device; introducing the distal end of said at least one second delivery tool at least partially into subannular intervertebral disc space; deploying at least one fixation device into, or through, the wall of an annulus to hold said treatment device at least partially within the subannular intervertebral disc space. removing said at least one second delivery tool; removing said first delivery tool. 20. The method of
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28. A fixation device useful for intervertebral disc reconstruction for treating a disc having an aperture, weakened, or thin portion in the wall of the annulus fibrosis of said intervertebral disc, said device comprising:
at least one anchor portion and at least one band. 29. The device of
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Description This application is a continuation of co-pending U.S. application Ser. No. 10/055,504, filed on Oct. 25, 2001, which claims benefit to 60/311,586 filed Aug. 10, 2001 and which is a continuation-in-part of U.S. application Ser. No. 09/696,636 filed on Oct. 25, 2000, now issued as U.S. Pat. No. 6,508,839, which is a continuation-in-part of U.S. application Ser. No. 09/642,450 filed on Aug. 18, 2000, now issued as U.S. Pat. No. 6,482,235, which is a continuation-in-part of U.S. application Ser. No. 09/608,797 filed on Jun. 30, 2000, now issued as U.S. Pat. No. 6,425,919, which claims benefit to U.S. Provisional Application No. 60/172,996 filed Dec. 21, 1999, U.S. Provisional Application No. 60/161,085 filed Oct. 25, 1999, and U.S. Provisional Application No. 60/149,490 filed Aug. 18, 1999, the entire teachings of these applications being incorporated herein by reference. 1. Field of the Invention The present invention relates to the surgical treatment of intervertebral discs in the lumbar, cervical, or thoracic spine that have suffered from tears in the anulus fibrosis, herniation of the nucleus pulposus and/or significant disc height loss. 1. Description of the Related Art The disc performs the important role of absorbing mechanical loads while allowing for constrained flexibility of the spine. The disc is composed of a soft, central nucleus pulposus (NP) surrounded by a tough, woven anulus fibrosis (AF). Herniation is a result of a weakening in the AF. Symptomatic herniations occur when weakness in the AF allows the NP to bulge or leak posteriorly toward the spinal cord and major nerve roots. The most common resulting symptoms are pain radiating along a compressed nerve and low back pain, both of which can be crippling for the patient. The significance of this problem is increased by the low average age of diagnosis, with over 80% of patients in the U.S. being under 59. Systems and methods for repairing tears in soft tissues are known in the art. Also, disclosed in the art are methods of augmenting the intervertebral disc. However, the efficacious treatment of intervertebral discs has not been adequately addressed using the systems and methods in the art. Accordingly, there still remains a need for devices and methods to treat intervertebral discs that have been compromised, including, but not limited to, discs that have suffered from tears in the anulus fibrosis, herniation of the nucleus pulposus and/or significant disc height loss. Various embodiments of the present invention seek to exploit the individual characteristics of various anulus and nuclear augmentation devices to optimize the performance of both within the intervertebral disc. A primary function of anulus augmentation devices is to prevent or minimize the extrusion of materials from within the space normally occupied by the nucleus pulposus and inner anulus fibrosus. A primary function of nuclear augmentation devices is to at least temporarily add material to restore diminished disc height and pressure. Nuclear augmentation devices can also induce the growth or formation of material within the nuclear space. Accordingly, the inventive combination of these devices can create a synergistic effect wherein the anulus and nuclear augmentation devices serve to restore biomechanical function in a more natural biomimetic way. Furthermore, according to the invention both devices may be delivered more easily and less invasively. Also, the pressurized environment made possible through the addition of nuclear augmentation material and closing of the anulus serves both to restrain the nuclear augmentation and anchor the anulus augmentation in place. One or more of the embodiments of the present invention also provide non-permanent, minimally invasive and removable devices for closing a defect in an anulus and augmenting the nucleus. One or more of the embodiments of the present invention additionally provide an anulus augmentation device that is adapted for use with flowable nuclear augmentation material such that the flowable material cannot escape from the anulus after the anulus augmentation device has been implanted. There is provided in accordance with one aspect of the present invention, a disc augmentation system configured to repair or rehabilitate an intervertebral disc. The system comprises at least one anulus augmentation device, and at least one nuclear augmentation material. The anulus augmentation device prevents or minimizes the extrusion of materials from within the space normally occupied by the nucleus pulposus and inner anulus fibrosus. In one application of the invention, the anulus augmentation device is configured for minimally invasive implantation and deployment. The anulus augmentation device may either be a permanent implant, or removable. The nuclear augmentation material may restore diminished disc height and/or pressure. It may include factors for inducing the growth or formation of material within the nuclear space. It may either be permanent, removable, or absorbable. The nuclear augmentation material may be in the form of liquids, gels, solids, or gases. It may include any/or combinations of steroids, antibiotics, tissue necrosis factors, tissue necrosis factor antagonists, analgesics, growth factors, genes, gene vectors, hyaluronic acid, noncross-linked collagen, collagen, fibren, liquid fat, oils, synthetic polymers, polyethylene glycol, liquid silicones, synthetic oils, saline and hydrogel. The hydrogel may be selected from the group consisting of acrylonitriles, acrylic acids, polyacrylimides, acrylimides, acrylimidines, polyacrylnitriles, and polyvinyl alcohols. Solid form nuclear augmentation materials may be in the form of geometric shapes such as cubes, spheroids, disc-like components, ellipsoid, rhombohedral, cylindrical, or amorphous. The solid material may be in powder form, and may be selected from the group consisting of titanium, stainless steel, nitinol, cobalt, chrome, resorbable materials, polyurethane, polyesther, PEEK, PET, FEP, PTFE, ePTFE, PMMA, nylon, carbon fiber, Delrin, polyvinyl alcohol gels, polyglycolic acid, polyethylene glycol, silicone gel, silicone rubber, vulcanized rubber, gas-filled vesicles, bone, hydroxy apetite, collagen such as cross-linked collagen, muscle tissue, fat, cellulose, keratin, cartilage, protein polymers, transplanted nucleus pulposus, bioengineered nucleus pulposus, transplanted anulus fibrosis, and bioengineered anulus fibrosis. Structures may also be utilized, such as inflatable balloons or other inflatable containers, and spring-biased structures. The nuclear augmentation material may additionally comprise a biologically active compound. The compound may be selected from the group consisting of drug carriers, genetic vectors, genes, therapeutic agents, growth renewal agents, growth inhibitory agents, analgesics, anti-infectious agents, and anti-inflammatory drugs. In accordance with another aspect of the present invention, there is provided a method of repairing or rehabilitating an intervertebral disk. The method comprises the steps of inserting at least one anulus augmentation device into the disc, and inserting at least one nuclear augmentation material, to be held within the disc by the anulus augmentation device. The nuclear augmentation material may conform to a first, healthy region of the anulus, while the anulus augmentation device conforms to a second, weaker region of the anulus. In one embodiment, a method of repairing a herniated disc is provided. In one aspect, at least a portion of the herniated segment is displaced to within the pre-herniated borders of the disc and at least a portion of the displaced herniated segment is anchored to a site within the functional spine unit. In a further aspect, a first anchor is attached to at least a portion of the herniated segment of a disc, a second anchor is attached to a site within the functional spine unit, at least one connector is provided which joins the first and second anchors, and tension is applied between the first and second anchors along the connector to cause the herniated segment to move within the pre-herniated borders of the disc. In one embodiment, biocompatible material is inserted into the disc space to aid in restoring disc height. In several aspects of the invention, the connector includes, but is not limited to one or more sutures, wires, rigid rods, broad bands, pins, woven tubes and webs. In one embodiment, a method of repairing a herniated disc that includes displacing at least a portion of the herniated segment to within the pre-herniated borders of the disc and anchoring at least a portion of the displaced herniated segment to a site within the functional spine unit is provided. In one aspect, this method further includes attaching a first anchor to at least a portion of the herniated segment of a disc, attaching a second anchor to a site within the functional spine unit, providing at least one connector which joins the first and second anchors and applying tension between the first and second anchors along the connector means to cause the herniated segment to move within the pre-herniated borders of the disc. In a further aspect, biocompatible material is inserted into the disc space. In one embodiment, the material is added to aid in restoring disc height. In one aspect, at least a portion of the biocompatible material is attached to the connector. In several embodiments, the step of anchoring at least a portion of the displaced herniated segment to a site within the functional spine unit includes anchoring at least a portion of the displaced herniated segment to the superior vertebral body, inferior vertebral body, anterior anulus fibrosus, anterior medial anulus fibrosus and/or anterior lateral anulus fibrosus. Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when taken together with the attached drawings and claims. The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. FIGS. 29A-D depict deployment of a barrier from an entry site remote from the defect in the anulus fibrosis. FIGS. 37A-C illustrate a front, side, and perspective view, respectively, of an alternate embodiment of the expansion means shown in FIGS. 39A-D illustrate a tubular expansion means having a circular cross-section. FIGS. 40A-D illustrate a tubular expansion means having an oval shaped cross-section. FIGS. 41A-D illustrate a tubular expansion means having an egg-shaped cross-section. FIGS. 49A-G illustrate a method of implanting an intradiscal implant. FIGS. 50A-F show an alternate method of implanting an intradiscal implant. FIGS. 51A-C show another alternate method of implanting an intradiscal implant. FIGS. 60A-C illustrate a dissector component. FIGS. 61A-D illustrate a method of inserting a disc implant within an intervertebral disc. The present invention provides for an in vivo augmented functional spine unit. A functional spine unit includes the bony structures of two adjacent vertebrae (or vertebral bodies), the soft tissue (anulus fibrosis (AF), and optionally nucleus pulposus (NP)) of the intervertebral disc, and the ligaments, musculature and connective tissue connected to the vertebrae. The intervertebral disc is substantially situated in the intervertebral space formed between the adjacent vertebrae. Augmentation of the functional spine unit can include repair of a herniated disc segment, support of a weakened, torn or damaged anulus fibrosis, or the addition of material to or replacement of all or part of the nucleus pulposus. Augmentation of the functional spine unit is provided by herniation constraining devices and disc augmentation devices situated in the intervertebral disc space. Intervertebral disc 15 is comprised of the outer AF 10 which normally surrounds and constrains the NP 20 to be wholly within the borders of the intervertebral disc space. In Partial disruption 121 of the inner layers of the anulus 10 without a true perforation has also been linked to chronic low back pain. Such a disruption 4 is illustrated in In one embodiment of the present invention, the disc herniation constraining devices 13 provide support for returning all or part of the herniated segment 30 to a position substantially within its pre-herniated borders 40. The disc herniation constraining device includes an anchor which is positioned at a site within the functional spine unit, such as the superior or inferior vertebral body, or the anterior medial, or anterior lateral anulus fibrosis. The anchor is used as a point against which all or part of the herniated segment is tensioned so as to return the herniated segment to its pre-herniated borders, and thereby relieve pressure on otherwise compressed neural tissue and structures. A support member is positioned in or posterior to the herniated segment, and is connected to the anchor by a connecting member. Sufficient tension is applied to the connecting member so that the support member returns the herniated segment to a pre-herniated position. In various embodiments, augmentation material is secured within the intervertebral disc space, which assists the NP in cushioning and supporting the inferior and superior vertebral bodies. An anchor secured in a portion of the functional spine unit and attached to the connection member and augmentation material limits movement of the augmentation material within the intervertebral disc space. A supporting member, located opposite the anchor, may optionally provide a second point of attachment for the connection member and further hinder the movement of the augmentation material within the intervertebral disc space. Anchor 1 is depicted in a representative form, as it can take one of many suitable shapes, be made from one of a variety of biocompatible materials, and be constructed so as to fall within a range of stiffness. It can be a permanent device constructed of durable plastic or metal or can be made from a resorbable material such as polylactic acid (PLA) or polyglycolic acid (PGA). Specific embodiments are not shown, but many possible designs would be obvious to anyone skilled in the art. Embodiments include, but are not limited to, a barbed anchor made of PLA or a metal coil that can be screwed into the anterior AF. Anchor 1 can be securely established within a portion of the functional spine unit in the usual and customary manner for such devices and locations, such as being screwed into bone, sutured into tissue or bone, or affixed to tissue or bone using an adhesive method, such as cement, or other suitable surgical adhesives. Once established within the bone or tissue, anchor I should remain relatively stationary within the bone or tissue. Support member 2 is also depicted in a representative format and shares the same flexibility in material and design as anchor 1. Both device elements can be of the same design, or they can be of different designs, each better suited to being established in healthy and diseased tissue respectively. Alternatively, in other forms, support member 2 can be a cap or a bead shape, which also serves to secure a tear or puncture in the AF, or it can be bar or plate shaped, with or without barbs to maintain secure contact with the herniated segment. Support member 2 can be established securely to, within, or posterior to the herniated segment. The anchor and support member can include suture, bone anchors, soft tissue anchors, tissue adhesives, and materials that support tissue ingrowth although other forms and materials are possible. They may be permanent devices or resorbable. Their attachment to a portion of FSU and herniated segment must be strong enough to resist the tensional forces that result from repair of the hernia and the loads generated during daily activities. Connection member 3 is also depicted in representative fashion. Member 3 may be in the format of a flexible filament, such as a single or multi-strand suture, wire, or perhaps a rigid rod or broad band of material, for example. The connection member can further include suture, wire, pins, and woven tubes or webs of material. It can be constructed from a variety of materials, either permanent or resorbable, and can be of any shape suitable to fit within the confines of the intervertebral disc space. The material chosen is preferably adapted to be relatively stiff while in tension, and relatively flexible against all other loads. This allows for maximal mobility of the herniated segment relative to the anchor without the risk of the supported segment moving outside of the pre-herniated borders of the disc. The connection member may be an integral component of either the anchor or support member or a separate component. For example, the connection member and support member could be a length of non-resorbing suture that is coupled to an anchor, tensioned against the anchor, and sewn to the herniated segment. Generally, a suitable position for affixing one or more anchors is a location anterior to the herniated segment such that, when tension is applied along connection member 3, herniated segment 30 is returned to a site within the pre-herniated borders 40. The site chosen for the anchor should be able to withstand the tensile forces applied to the anchor when the connection member is brought under tension. Because most symptomatic herniations occur in the posterior or posterior lateral directions, the preferable site for anchor placement is anterior to the site of the herniation. Any portion of the involved FSU is generally acceptable, however the anterior, anterior medial, or anterior lateral AF is preferable. These portions of the AF have been shown to have considerably greater strength and stiffness than the posterior or posterior lateral portions of the AF. As shown in FIGS. 4A and 4B, anchor 1 can be a single anchor in any of the shown locations, or there can be multiple anchors 1 affixed in various locations and connected to a support member 2 to support the herniated segment. Connection member 3 can be one continuous length that is threaded through the sited anchors and the support member, or it can be several individual strands of material each terminated under tension between one or more anchors and one or more support members. In various forms of the invention, the anchor(s) and connection member(s) may be introduced and implanted in the patient, with the connection member under tension. Alternatively, those elements may be installed, without introducing tension to the connection member, but where the connection member is adapted to be under tension when the patient is in a non-horizontal position, i.e., resulting from loading in the intervertebral disc. FIGS. 5A-C show an alternate embodiment of herniation constraining device 13A. In this series of figures, device 13A, a substantially one-piece construct, is delivered through a delivery tube 6, although device 13A could be delivered in a variety of ways including, but not limited to, by hand or by a hand held grasping instrument. In FIGS. 6 depicts the substantially one-piece device 13A supporting a weakened segment 30′ of the posterior AF 10′. Device 13A is positioned in or posterior to the weakened segment 30′ and secured to a portion of the FSU, such as the superior vertebral body 50, shown in the figure, or the inferior vertebral body 50′ or anterior or anterior-lateral anulus fibrosis 10. In certain patients, there may be no obvious herniation found at surgery. However, a weakened or torn AF that may not be protruding beyond the pre-herniated borders of the disc may still induce the surgeon to remove all or part of the NP in order to decrease the risk of herniation. As an alternative to discectomy, any of the embodiments of the invention may be used to support and perhaps close defects in weakened segments of AF. A further embodiment of the present invention involves augmentation of the soft tissues of the intervertebral disc to avoid or reverse disc height loss. Augmentation material 7 may have a passageway 9, such as a channel, slit or the like, which allows it to slide along the connection member 3, or augmentation material 7 may be solid, and connection member 3 can be threaded through augmentation material by means such as needle or other puncturing device. Connection member 3 is affixed at one end to anchor 1 and terminated at its other end by a support member 2′, one embodiment of which is shown in the figure in a cap-like configuration. Support member 2′ can be affixed to connection member 3 in a variety of ways, including, but not limited to, swaging support member 2′ to connection member 3. In a preferred embodiment, support member 2′ is in a cap configuration and has a dimension (diameter or length and width) larger than the optional passageway 9, which serves to prevent augmentation material 7 from displacing posteriorly with respect to anchor 1. The right half of the intervertebral disc of Augmentation or spacer material can be made of any biocompatible, preferably flexible, material. Such a flexible material is preferably fibrous, like cellulose or bovine or autologous collagen. The augmentation material can be plug or disc shaped. It can further be cube-like, ellipsoid, spheroid or any other suitable shape. The augmentation material can be secured within the intervertebral space by a variety of methods, such as but not limited to, a suture loop attached to, around, or through the material, which is then passed to the anchor and support member. Any of the devices described herein can be used for closing defects in the AF whether created surgically or during the herniation event. Such methods may also involve the addition of biocompatible material to either the AF or NP. This material could include sequestered or extruded segments of the NP found outside the pre-herniated borders of the disc. The method consists of inserting the barrier 12 into the interior of the disc 15 and positioning it proximate to the interior aspect of the anulus defect 16. The barrier material is preferably considerably larger in area than the size of the defect 16, such that at least some portion of the barrier means 12 abuts healthier anulus fibrosis 10. The device acts to seal the anulus defect 16, recreating the closed isobaric environment of a healthy disc nucleus 20. This closure can be achieved simply by an over-sizing of the implant relative to the defect 16. It can also be achieved by affixing the barrier means 12 to tissues within the functional spinal unit. In a preferred aspect of the present invention, the barrier 12 is affixed to the anulus surrounding the anulus defect 16. This can be achieved with sutures, staples, glues or other suitable fixation means or fixation device 14. The barrier means 12 can also be larger in area than the defect 16 and be affixed to a tissue or structure opposite the defect 16, i.e. anterior tissue in the case of a posterior defect. The barrier means 12 is preferably flexible in nature. It can be constructed of a woven material such as Dacron� or Nylon�, a synthetic polyamide or polyester, a polyethylene, and can further be an expanded material, such as expanded polytetrafluroethylene (e-PTFE), for example. The barrier means 12 can also be a biologic material such as cross-linked collagen or cellulous. The barrier means 12 can be a single piece of material. It can have an expandable means or component that allows it to be expanded from a compressed state after insertion into the interior of the disc 15. This expandable means can be active, such as a balloon, or passive, such as a hydrophilic material. The expandable means can also be a self-expanding elastically deforming material, for example. The barrier means 12 can also be anchored to the disc 15 in multiple locations. In one preferred embodiment, shown in The barrier means 12 can further be integral to a fixation means such that the barrier means affixes itself to tissues within the functional spinal unit. Any of the methods described above can be augmented by the use of a second barrier or a second barrier means 24 placed proximate to the outer aspect of the defect 16 as shown in To prevent further herniation of the nucleus 20 and to repair any present herniation, in a preferred embodiment, a barrier or barrier means 12 can be placed into a space between the anulus 10 and the nucleus 20 proximate to the inner aspect 32 of defect 16, as depicted in In position, the barrier means 12 preferably spans the defect 16 and extends along the interior aspect 36 of the anulus 10 until it contacts healthy tissues on all sides of the defect 16, or on a sufficient extent of adjacent healthy tissue to provide adequate support under load. Healthy tissue may be non-diseased tissue and/or load bearing tissue, which may be micro-perforated or non-perforated. Depending on the extent of the defect 16, the contacted tissues can include the anulus 10, cartilage overlying the vertebral endplates, and/or the endplates themselves. In the preferred embodiment, the barrier means 12 comprises two components�a sealing means or sealing component 51 and an enlarging means or enlarging component 53, shown in The sealing means 51 forms the periphery of the barrier 12 and has an interior cavity 17. There is at least one opening 8 leading into cavity 17 from the exterior of the sealing means 51. Sealing means 51 is preferably compressible or collapsible to a dimension that can readily be inserted into the disc 15 through a relatively small hole. This hole can be the defect 16 itself or a site remote from the defect 16. The sealing means 51 is constructed from a material and is formed in such a manner as to resist the passage of fluids and other materials around sealing means 51 and through the defect 16. The sealing means 51 can be constructed from one or any number of a variety of materials including, but not limited to PTFE, e-PTFE, Nylon�, Marlex�, high-density polyethylene, and/or collagen. The thickness of the sealing component has been found to be optimal between about 0.001 inches (0.127 mm) and 0.063 inches (1.6 mm). The enlarging means 53 can be sized to fit within cavity 17 of sealing means 51. It is preferably a single object of a dimension that can be inserted through the same defect 16 through which the sealing means 51 was passed. The enlarging means 53 can expand the sealing means 51 to an expanded state as it is passed into cavity 17. One purpose of enlarging means 53 is to expand sealing means 51 to a size greater than that of the defect 16 such that the assembled barrier 12 prevents passage of material through the defect 16. The enlarger 53 can further impart stiffness to the barrier 12 such that the barrier 12 resists the pressures within nucleus pulposus 20 and expulsion through the defect 16. The enlarging means 53 can be constructed from one or any number of materials including, but not limited to, silicon rubber, various plastics, stainless steel, nickel titanium alloys, or other metals. These materials may form a solid object, a hollow object, coiled springs or other suitable forms capable of filling cavity 17 within sealing means 51. The sealing means 51, enlarging means 53, or the barrier means 12 constructs can further be affixed to tissues either surrounding the defect 16 or remote from the defect 16. In the preferred embodiment, no aspect of a fixation means or fixation device or the barrier means 12 nor its components extend posterior to the disc 15 or into the extradiscal region 500, avoiding the risk of contacting and irritating the sensitive nerve tissues posterior to the disc 15. In a preferred embodiment, the sealing means 51 is inserted into the disc 15 proximate the interior aspect 36 of the defect. The sealing means 51 is then affixed to the tissues surrounding the defect using a suitable fixation means, such as suture or a soft-tissue anchor. The fixation procedure is preferably performed from the interior of the sealing means cavity 17 as depicted in Another method of securing the barrier 12 to tissues is to affix the enlarging means 53 to tissues either surrounding or remote from the defect 16. The enlarging means 53 can have an integral fixation region 4 that facilitates securing it to tissues as depicted in Another method of securing the barrier means 12 is to insert the barrier means 12 through the defect 16 or another opening into the disc 15, position it proximate to the interior aspect 36 of the defect 16, and pass at least one fixation means 14 through the anulus 10 and into the barrier 12. In a preferred embodiment of this method, the fixation means 14 can be darts 15 and are first passed partially into anulus 10 within a fixation device 120, such as a hollow needle. As depicted in In another aspect of the present invention, the barrier (or �patch�) 12 can be placed between two neighboring layers 33, 37 (lamellae) of the anulus 10 on either or both sides of the defect 16 as depicted in A dissecting tool can be used to form an opening extending circumferentially 31 within the anulus fibrosis such that the barrier can be inserted into the opening. Alternatively, the barrier itself can have a dissecting edge such that it can be driven at least partially into the sidewalls of defect 16, annulotomy 416, access hole 417 or opening in the anulus. This process can make use of the naturally layered structure in the anulus in which adjacent layers 33, 37 are defined by a circumferentially extending boundary 35 between the layers. Another embodiment of the barrier 12 is a patch having a length, oriented along the circumference of the disc, which is substantially greater than its height, which is oriented along the distance separating the surrounding vertebral bodies. A barrier 12 having a length greater than its height is illustrated in The barrier 12 can be used in conjunction with an augmentation device 11 inserted within the anulus 10. The augmentation device 11 can include separate augmentation devices 42 as shown in In another embodiment of the present invention, the barrier or patch 12 may be used as part of a method to augment the intervertebral disc. In one aspect of this method, augmentation material or devices are inserted into the disc through a defect (either naturally occurring or surgically generated). Many suitable augmentation materials and devices are discussed above and in the prior art. As depicted in FIGS. 29A-D illustrate the deployment of a barrier 12 from an entry site 800 remote from the defect in the anulus fibrosis 10. Another method of securing the barrier means 12 is to adhere it to surrounding tissues through the application of heat. In this embodiment, the barrier means 12 includes a sealing means 51 comprised of a thermally adherent material that adheres to surrounding tissues upon the application of heat. The thermally adherent material can include thermoplastic, collagen, or a similar material. The sealing means 51 can further comprise a separate structural material that adds strength to the thermally adherent material, such as a woven Nylon� or Marlex�. This thermally adherent sealing means preferably has an interior cavity 17 and at least one opening 8 leading from the exterior of the barrier means into cavity 17. A thermal device can be attached to the insertion instrument shown in The barrier means 12 shown in The cross section of the barrier 12 can be any of a number of shapes. Each embodiment exploits a sealing means 51 and an enlarging means 53 that may further add stiffness to the overall barrier construct. The expansion means 53 shown in The patterns shown in This embodiment employs a multitude of fingers 162 to aid in holding a flexible sealer or membrane against the superior and inferior vertebral endplates. The distance between the superior-most point of the superior finger and the inferior-most point on the inferior finger is the expansion means height 172. This height 172 is preferably greater than the disc height at the inner surface of the posterior anulus. The greater height 172 of the expander 153 allows the fingers 162 to deflect along the superior and inferior vertebral endplates, enhancing the seal of the barrier means 12 against egress of material from within the disc 15. The spacing between the fingers 162 along the expander length 170 can be tailored to provide a desired stiffness of the expansion means 153. Greater spacing between any two neighboring fingers 162 can further be employed to insure that the fingers 170 do not touch if the expansion means 153 is required to take a bend along its length. The central strut 164 can connect the fingers and dissecting ends and preferably lies along the inner surface of the anulus 10 when seated within the disc 15. Various embodiments may employ struts 164 of greater or lesser heights and thicknesses to vary the stiffness of the overall expansion means 153 along its length 170 and height 172. The bending stiffness of expander 153 can resist migration of the implant from this preferred position within the disc 15. The principle behind this stiffness-based stability is to place the regions of expander 153 with the greatest flexibility in the regions of the disc 153 with the greatest mobility or curvature. These flexible regions of expander 153 are surrounded by significantly stiffer regions. Hence, in order for the implant to migrate, a relatively stiff region of the expander must move into a relatively curved or mobile region of the disc. For example, in order for expander 153 of The expander 153 is preferably covered by a membrane that acts to further restrict the movement of materials through the frame and toward the outer periphery of the anulus fibrosis. FIGS. 37A-C depict a further embodiment of the frame or expander 153. This embodiment employs a central lattice 180 consisting of multiple, fine interconnected struts 182. Such a lattice 180 can provide a structure that minimizes bulging of the sealing means 51 under intradiscal pressures. The orientation and location of these struts 182 have been designed to give the barrier 12 a bend-axis along the central area of the expander height 172. The struts 182 support inferior 168 and superior 166 fingers 162 similar to previously described embodiments. However, these fingers 162 can have varying dimensions and stiffness along the length of the barrier 12. Such fingers 162 can be useful for helping the sealer 51 conform to uneven endplate geometries. The embodiment of the frame 153 as shown in FIGS. 37A-C, can also be employed without the use of a covering membrane. The nucleus pulposus of many patients with low back pain or disc herniation can degenerate to a state in which the material properties of the nucleus cause it to behave much more like a solid than a gel. As humans age, the water content of the nucleus declines from roughly 88% to less than 75%. As this occurs, there is an increase in the cross linking of collagen within the disc resulting in a greater solidity of the nucleus. When the pore size or the largest open area of any given gap in the lattice depicted in tubular expander 154 can deploy against the superior and inferior vertebral endplates, respectively. The distance 186 between the superior 166 and inferior 168 surfaces of the expander 154 are preferably equal to or greater than the posterior disc height at the inner surface of the anulus 10. This embodiment has an anulus face 188 and nucleus face 190 as shown in The struts 192 can be spaced to provide nuclear gaps 194. These gaps 194 can encourage the flow of nucleus pulposus 20 into the interior of the expander 154. This flow can insure full expansion of the barrier 12 within the disc 15 during deployment. The embodiments of FIGS. 42A-D depict cross sections of a preferred embodiment of sealing means 51 and enlarging means 53. Sealing means 51 has internal cavity 17 and opening 8 leading from its outer surface into internal cavity 17. Enlarger 53 can be inserted through opening 8 and into internal cavity 17. Pulling on the control filament 406 causes the implant 400 to move toward the annulotomy 416. The distal end 410 of the delivery cannula 402 can be used to direct the proximal end 420 of the implant 400 (that portion of the implant 400 that is last to be expelled from the delivery cannula 402) away from the annulotomy 416 and toward an inner aspect of the anulus 10 nearest the desired implant location. Alternately, the advancer 404 can be used to position the proximal end of the implant toward an inner aspect of the anulus 20 near the implant location, as shown in The implant 400 can be any of the following: nucleus replacement device, nucleus augmentation device, anulus augmentation device, anulus replacement device, the barrier of the present invention or any of its components, drug carrier device, carrier device seeded with living cells, or a device that stimulates or supports fusion of the surrounding vertebra. The implant 400 can be a membrane which prevents the flow of a material from within the anulus fibrosis of an intervertebral disc through a defect in the disc. The material within the anulus fibrosis can be, for example, a nucleus pulposus or a prosthetic augmentation device, such as hydrogel. The membrane can be a sealer. The implant 400 can be wholly or partially rigid or wholly or partially flexible. It can have a solid portion or portions that contain a fluid material. It can comprise a single or multitude of materials. These materials can include metals, polymers, gels and can be in solid or woven form. The implant 400 can either resist or promote tissue ingrowth, whether fibrous or bony. The cannula 402 can be any tubular device capable of advancing the implant 400 at least partially through the anulus 10. It can be made of any suitable biocompatible material including various known metals and polymers. It can be wholly or partially rigid or flexible. It can be circular, oval, polygonal, or irregular in cross section. It must have an opening at least at its distal end 410, but can have other openings in various locations along its length. The advancer 404 can be rigid or flexible, and have one of a variety of cross sectional shapes either like or unlike the delivery cannula 402. It may be a solid or even a column of incompressible fluid, so long as it is stiff enough to advance the implant 400 into the disc 15. The advancer 404 can be contained entirely within the cannula 402 or can extend through a wall or end of the cannula to facilitate manipulation. Advancement of the implant 400 can be assisted by various levers, gears, screws and other secondary assist devices to minimize the force required by the surgeon to advance the implant 400. These secondary devices can further give the user greater control over the rate and extent of advancement into the disc 15. The guide filament 406 may be a string, rod, plate, or other elongate object that can be secured to and move with the implant 400 as it is advanced into the disc 15. It can be constructed from any of a variety of metals or polymers or combination thereof and can be flexible or rigid along all or part of its length. It can be secured to a secondary object 418 or device at its end opposite that which is secured to the implant 400. This secondary device 418 can include the advancer 404 or other object or device that assists the user in manipulating the filament. The filament 406 can be releasably secured to the implant 400, as shown in Multiple guide filaments can be secured to the implant 400 at various locations. In one preferred embodiment, a first or distal 422 and a second or proximal 424 guide filament are secured to an elongate implant 400 at or near its distal 412 and proximal 420 ends at attachment sites 426 and 428, respectively. These ends 412 and 420 correspond to the first and last portions of the implant 400, respectively, to be expelled from the delivery cannula 402 when advanced into the disc 15. This double guide filament system allows the implant 400 to be positioned in the same manner described above in the single filament technique, and illustrated in FIGS. 50A-C. However, following completion of this first technique, the user may advance the proximal end 420 of the device 400 across the annulotomy 416 by pulling on the second guide filament 424, shown in Both the first 422 and second 424 guide filaments can be simultaneously tensioned, as shown in In another embodiment of the present invention, as illustrated in FIGS. 51A-C, an implant guide 430 may be employed to aid directing the implant 400 through the annulotomy 416, through the nucleus pulposus 10, and/or along the inner aspect of the anulus 10. This implant guide 430 can aid in the procedure by dissecting through tissue, adding stiffness to the implant construct, reducing trauma to the anulus or other tissues that can be caused by a stiff or abrasive implant, providing 3-D control of the implants orientation during implantation, expanding an expandable implant, or temporarily imparting a shape to the implant that is beneficial during implantation. The implant guide 430 can be affixed to either the advancer 404 or the implant 406 themselves. In a preferred embodiment shown in The implant guide 430 is releasable from the implant 400 following or during implantation. This release may be coordinated with the release of the guide filaments 422 and 424. The implant guide 430 may further be able to slide along the guide filaments 422 and 424 while these filaments are secured to the implant 400. Various embodiments of the barrier 12 or implant 400 can be secured to tissues within the intervertebral disc 15 or surrounding vertebrae. It can be advantageous to secure the barrier means 12 in a limited number of sites while still insuring that larger surfaces of the barrier 12 or implant juxtapose the tissue to which the barrier 12 is secured. This is particularly advantageous in forming a sealing engagement with surrounding tissues. Each stiffening element can aid in securing segments of the barrier 12 to surrounding tissues. The stiffening elements can have parts 307, including through-holes, notches, or indentations for example, to facilitate fixation of the stiffening element 300 to surrounding tissues by any of a variety of fixation devices 306. These fixation devices 306 can include screws, darts, dowels, or other suitable means capable of holding the barrier 12 to surrounding tissue. The fixation devices 306 can be connected either directly to the stiffening element 300 or indirectly using an intervening length of suture, cable, or other filament for example. The fixation device 306 can further be secured to the barrier 12 near the stiffening element 300 without direct contact with the stiffening element 300. The fixation device 306 can be secured to or near the stiffening element 300 at opposing ends of the length of the barrier 12 required to be in sealing engagement with surrounding tissues. Alternatively, one or a multitude of fixation devices 306 can be secured to or near the stiffening element 300 at a readily accessible location that may not be at these ends. In any barrier 12 embodiment with an interior cavity 17 and an opening 8 leading thereto, the fixation sites may be proximal to the opening 8 to allow passage of the fixation device 306 and various instruments that may be required for their implantation. Various methods may be employed to decrease the forces necessary to maneuver the barrier 12 into a position along or within the lamellae of the anulus fibrosis 10. FIGS. 60A-C depict an alternate dissector component 480 of In the undeployed state depicted in Certain embodiments, as shown in Fluid nuclear augmentation 554 is particularly well-suited for use in various aspects of the current invention because it can be delivered with minimal invasiveness and because it is able to flow into and fill minute voids of the intervertebral disc space. Fluid nuclear augmentation 554 is also uniquely suited for maintaining a pressurized environment that evenly transfers the force exerted by the endplates to the anulus augmentation device and/or the anulus. However, fluid nuclear augmentation materials 554 used alone may perform poorly in discs 15 with a degenerated anulus because the material can flow back out through anulus defects 8 and pose a risk to surrounding structures. This limitation is overcome by several embodiments of the current invention because the barrier 12 shunts the pressure caused by the fluid augmentation 554 away from the damaged anulus region 8 and toward healthier regions, thus restoring function to the disc 15 and reducing risk of the extrusion of nuclear augmentation materials 7 and fluid augmentation material 554. Exemplary fluid nuclear augmentation materials 554 include, but are not limited to, various pharmaceuticals (steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics); growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils); and saline. One skilled in the art will understand that any one of these materials may be used alone or that a combination of two or more of these materials may be used together to form the nuclear augmentation material. Any of a variety of additional additives such as thickening agents, carriers, polymerization initiators or inhibitors may also be included, depending upon the desired infusion and long-term performance characteristics. In general, �fluid� is used herein to include any material which is sufficiently flowable at least during the infusion process, to be infused through an infusion lumen in the delivery device into the disc space. The augmentation material 554 may remain �fluid� after the infusion step, or may polymerize, cure, or otherwise harden to a less flowable or nonflowable state. Additional additives and components of the nucleus augmentation material are recited below. In general, the nature of the material 554 may remain constant during the deployment and post-deployment stages or may change, from a first infusion state to a second, subsequent implanted state. For example, any of a variety of materials may desirably be infused using a carrier such as a solvent or fluid medium with a dispersion therein. The solvent or liquid carrier may be absorbed by the body or otherwise dissipate from the disc space post-implantation, leaving the nucleus augmentation material 554 behind. For example, any of a variety of the powders identified below may be carried using a fluid carrier. In addition, hydrogels or other materials may be implanted or deployed while in solution, with the solvent dissipating post-deployment to leave the hydrogel or other media behind. In this type of application, the disc space may be filled under higher than ultimately desired pressure, taking into account the absorption of a carrier volume. Additional specific materials and considerations are disclosed in greater detail below. Solid or gel nuclear augmentation materials 7 used in various embodiments of the current invention include single piece or multiple pieces. The solid materials 7 may be cube-like, spheroid, disc-like, ellipsoid, rhombohedral, cylindrical, or amorphous in shape. These materials 7 may be in woven or non-woven form. Other forms of solids including minute particles or even powder can be considered when used in combination with the barrier device. Candidate materials 7 include, but are not limited to: metals, such as titanium, stainless steels, nitinol, cobalt chrome; resorbable or non-resorbing synthetic polymers, such as polyurethane, polyester, PEEK, PET, FEP, PTFE, ePTFE, Teflon, PMMA, nylon, carbon fiber, Delrin, polyvinyl alcohol gels, polyglycolic acid, polyethylene glycol; silicon gel or rubber, vulcanized rubber or other elastomer; gas filled vesicles, biologic materials such as morselized or block bone, hydroxy apetite, cross-linked collagen, muscle tissue, fat, cellulose, keratin, cartilage, protein polymers, transplanted or bioengineered nucleus pulposus or anulus fibrosus; or various pharmacologically active agents in solid form. The solid or gel augmentation materials 7 may be rigid, wholly or partially flexible, elastic or viscoelastic in nature. The augmentation device or material 7 may be hydrophilic or hydrophobic. Hydrophilic materials, mimicking the physiology of the nucleus, may be delivered into the disc in a hydrated or dehydrated state. Biologic materials may be autologous, allograft, zenograft, or bioengineered. In various embodiments of the present invention, the solid or gel nuclear augmentation material 7, as depicted in In one aspect of the invention, the nuclear augmentation material or device 7, 554 constructed therefrom is phase changing, i.e. from liquid to solid, solid to liquid, or liquid to gel. In situ polymerizing nuclear augmentation materials are well-known in the art and are described in U.S. Pat. No. 6,187,048, herein incorporated by reference. Phase changing augmentation preferably changes from a liquid to a solid or gel. Such materials may change phases in response to contact with air, increases or decreases in temperature, contact with biologic liquids or by the mixture of separate reactive constituents. These materials are advantageous because they can be delivered through a small hole in the anulus or down a tube or cannula placed percutaneously into the disc. Once the materials have solidified or gelled, they can exhibit the previously described advantages of a solid augmentation material. In a preferred embodiment, the barrier device is used to seal and pressurize a phase changing material to aid in its delivery by forcing it into the voids of the disc space while minimizing the risk of extrusion of the material while it is a fluid. In this situation, the barrier or anulus augmentation device 12 may be permanently implanted or used only temporarily until the desired phase change has occurred. Another aspect of the present invention includes an anulus augmentation device 12 that exploits the characteristics of nucleus augmentation devices or materials to improve its own performance. Augmenting the nucleus 20 pressurizes the intervertebral disc environment which can serve to fix or stabilize an anulus repair device in place. The nucleus 20 can be pressurized by inserting into the disc 15 an adequate amount of augmentation material 7, 554. In use, the pressurized disc tissue and augmentation material 7, 554 applies force on the inwardly facing surface of the anulus augmentation device 12. This pressure may be exploited by the design of the anulus prosthesis or barrier 12 to prevent it from dislodging or moving from its intended position. One exemplary method is to design the inwardly facing surface of the anulus prosthesis 12 to expand upon the application of pressure. As the anulus prosthesis 12 expands, it becomes less likely to be expelled from the disc. The prosthesis 12 may be formed with a concavity facing inward to promote such. expansion. In several embodiments, the anulus augmentation device 12 itself functions as nuclear augmentation 7. In a preferred embodiment, the barrier 12 frame is encapsulated in ePTFE. This construct typically displaces a volume of 0.6 cubic centimeters, although thicker coatings of ePTFE or like materials may be used to increase this volume to 3 cubic centimeters. Also, the anulus augmentation device may be designed with differentially thickened regions along its area. Alternatively, the anulus augmentation device 12 and nuclear augmentation material 7 may be fabricated as a single device with a barrier 12 region and a nuclear augmentation region 7. As an example, the barrier 12 may form at least a portion of the surface of an augmentation sack 455 or balloon. The sack 455 may be filled with suitable augmentation materials 7 once the barrier has been positioned along a weakened inner surface of the anulus 10. The sequence of inserting the barrier 12 and nuclear augmentation 7 in the disc can be varied according to the nuclear augmentation 7 used or requirements of the surgical procedure. For example, the nuclear augmentation 7 can be inserted first and then sealed in place by the barrier device 12 . Alternatively, the disc 15 can be partially filled, then sealed with the barrier device 12, and then supplied with additional material 7. In a preferred embodiment, the barrier device 12 is inserted into the disc 15 followed by the addition of nuclear augmentation material 7 through or around the barrier 12. This allows for active pressurization. A disc 15 with a severely degenerated anulus can also be effectively treated in this manner. In an alternative embodiment, the nuclear augmentation material 7 is delivered through a cannula inserted through an access hole 417 in the disc 15 formed pathologically, e.g. an anular defect 8, or iatrogenically, e.g. an anuulotomy 416 that is distinct from the access hole 417 that was used to implant the barrier 12. Also, the same or different surgical approach including transpsoas, presacral, transsacral, tranpedicular, translaminar, or anteriorly through the abdomen, may be used. Access hole 417 can be located anywhere along the anulus surface or even through the vertebral endplates. In alternative embodiments, the anulus augmentation device 12 includes features that facilitate the introduction of augmentation materials 554 following placement. The augmentation delivery cannula may simply be forcibly driven into an access hole 417 proximal to the barrier 12 at a slight angle so that the edge of the barrier 12 deforms and allows passage into the disc space. Alternatively, a small, flexible or rigid curved delivery needle or tube may be inserted through an access hole 417 over (in the direction of the superior endplate) or under (in the direction of the inferior endplate) the barrier 12 or around an edge of the barrier 12 contiguous with the anulus 15. In several embodiments, ports or valves are installed in the barrier 12 device that permit the flow of augmentation material into, but not out of, the disc space. One-way valves 450 or even flaps of material held shut by the intervertebral pressure may be used. A collapsible tubular valve may be fashioned along a length of the barrier. In one embodiment, multiple valves or ports 450 are present along the device 12 to facilitate alignment with the access hole 417 and delivery of augmentation material. Flow channels within or on the barrier 12 to direct the delivery of the material 554 (e.g. to the ends of the barrier) can be machined, formed into or attached to the barrier 12 along its length. Alternatively, small delivery apertures (e.g. caused by a needle) can be sealed with a small amount of adhesive or sutured shut. One skilled in the art will appreciate that any of the above procedures involving nuclear augmentation and/or anulus augmentation may be performed with or without the removal of any or all of the autologous nucleus. Further, the nuclear augmentation materials and/or the anulus augmentation device may be designed to be safely and efficiently removed from the intervertebral disc in the event they no longer be required. While this invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. Patent Citations
Classifications Rotate |


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The art of being a workaholic without being a workaholic
Short-handed Cavaliers in tough spot heading into Game 2 against Chicago
Browns GM Ray Farmer's curious draft blueprint raises a few questions
With few words, Duke Realty Corp. says goodbye to Northeast Ohio
Quicken Loans Inc. raises $1.25 billion in its first bond issue
Marriott International Inc. out as Renaissance Cleveland Hotel operator effective June 30
Chef Jonathon Sawyer wins James Beard Award
Downtown Cleveland adds more retailers, apartment dwellers in first quarter
Forest City to acquire full ownership of life-science portfolio from Health Care REIT
Cleveland Clinic to publish health data on Apervita
Indiana's casinos suffer, and so do state's tax coffers
Blog Entry:
January 24, 2013 1:56 PM | Author: SCOTT SUTTELL
Indiana's casino operators and legislators are
looking nervously over their shoulders
at their new competitors — most prominently those in Ohio.
The New York Times
reports that since the mid-1990s, Indiana casinos "have filled state coffers with more than $10 billion in taxes and have drawn millions of visitors across state borders to try their luck at Indiana slot machines."
But those good times are ending.
"Citing a shaky economy and the growing threats of casino expansion in the neighboring states of Illinois, Kentucky and Ohio, a state report predicted 2012 'will be remembered as the relative calm before Indiana braces for the looming storm of interstate competition for gaming revenues,'" according to
The Times
. The state's incoming tax revenue from riverboat gambling alone is expected to dip by $73.6 million by 2015, a 15% decrease.
Indiana officials "seem most frightened of what is happening in Ohio, which opened its first three casinos in 2012," in Cleveland, Columbus and Toledo, according to
The Times
The new competition "has already been blamed for layoffs at Indiana casinos along the border," the newspaper says, and the situation for the Hoosier state could get worse with the opening in March of a Cincinnati casino.
The lesson,
The Times
concludes, is that as more states pursue casinos as an untapped revenue stream, they dilute the market for states that embraced casinos earlier. And if you're excited about what casinos bring to Ohio, just understand that someday, we'll be in Indiana's shoes.
See how they grow
Bloomberg runs a
long profile
of Bill Emerson, CEO of
Quicken Loans Inc.
, who has put the mortgage lender founded by
Cleveland Cavaliers
owner Dan Gilbert "near the very top of an industry that's reaping the rewards of a refinancing boom engineered by the Federal Reserve and President Barack Obama."
Quicken Loans "is taking advantage of the collapse of hundreds of rivals, retreats by some of the largest banks, and hurdles faced by new competitors," Bloomberg reports. The company in the third quarter overtook Citigroup Inc. as the country's fifth-largest mortgage originator, and it since has surpassed U.S. Bancorp and Bank of America Corp.
Lending jumped to $70 billion in 2012 from a previous record of $30 billion, but Mr. Emerson, 50, tells Bloomberg it still has room to grow.
"Our mission is to do as much or more than we did last year," says Mr. Emerson, a former walk-on at Penn State who became a captain of that university's 1982 national championship football team. "There's a massive market out there, and 93 out of 100 people still wake up and go somewhere else."
(That sounds
like something Mr. Gilbert would say.)
The company has a good chance to keep growing, says Mark Fleming, chief economist at real estate data firm CoreLogic Inc. He says unlike many rivals he has visited, Quicken's offices "buzz" with engaged employees, it runs a "slick marketing engine" and consumers are growing more used to online transactions.
"Things are changing and maybe you don't need those local relationships anymore," Fleming says.
This and that
Dream on:
Eaton Corp.
helping with the investigation
into the cause of a fuel leak blamed for a fire on one of Boeing's 787 Dreamliners.
"I can confirm we are fully supporting the investigation of the recent 787 fuel incident," an Eaton spokeswoman told Reuters. "Without speaking about either the incident or investigation, I can tell you that we do supply pumps and valves to the program."
The Times
of London
Wednesday that a factory run by Eaton's U.K. unit, Eaton Aerospace, may have produced a faulty valve actuator that caused a fuel leak blamed for a fire on one of the Dreamliners.
The paper said the plant in Hampshire, southern England, produced the part linked to the flow of fuel through sections of the plane.
One direction — down:
Four states in the industrial Midwest — Ohio, Indiana, Wisconsin and Michigan — accounted for about half the country's loss of unionized jobs in 2012, according to
this analysis
from Reuters.
The total number of union members fell by nearly 400,000, from 11.8% of the work force in 2011 to 11.3% in 2012, a U.S. Department of Labor report on union membership found. The 11.3% rate is the lowest since 1936.
Ohio alone
lost 43,000 union jobs
last year and now has 603,000 union members. (The state's 12.6% unionized rate remains above the national average.)
Union membership has been falling since 2008, when it was 16.1 million, or 12.4% of the work force, federal data show. Reuters says it peaked in 1954, when 28.3% of workers were represented by organized labor.
Your rich sports team owner update:
Ever wondered, "How many of the NBA's 30 team owners are billionaires?"
In case you did, Forbes.com
has your answer:
14, including the
Dan Gilbert, who's worth $1.9 billion.
The majority of the league's billionaires hail from smaller markets, Forbes.com says: Mr. Gilbert, Richard DeVos in Orlando, Herb Simon in Indiana and Paul Allen in Portland, to name a few.
"Wealthy owners certainly carry more value in smaller markets," the website notes. "Money for things like arena fix-ups, which Allen largely financed for Portland's Rose Garden, and brand new buildings to escape New Jersey in, which the Brooklyn Nets got thanks to (Mikhail) Prokhorov's partial buyout of Bruce Ratner, can get done despite relatively limited cash flows."
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subset: commoncrawl


text:
February 6, 2013 - 9:30 a.m.
Baby Discover (birth to 18 mths.)
Library: Herr
Location: Herr Memorial Library
Location: Herr Memorial Library
Discover programs offer a fun learning environment that both parents and children appreciate featuring stories read aloud, songs, crafts and more. Registration is required by calling 570-966-0831. This program is one of the ways in which Herr Memorial Library supports the PA Forward Initiative by providing Basic Literacy opportunities for learning.


text:
Photo Galleries
< MyNorthwest
Boston bombing suspect's hearing rescheduled again
Boston bombing suspect's hearing rescheduled again
5 of 25 |
Investigators work near the location where the previous night a suspect in the Boston Marathon bombings was arrested, Saturday, April 20, 2013, in Watertown, Mass. Police captured Dzhokhar Tsarnaev, 19, the surviving Boston Marathon bombing suspect, in a backyard boat after a wild car chase and gun battle earlier in the day left his older brother dead. (AP Photo/Matt Rourke)
Photo by Matt Rourke
Photo by Matt Rourke
5 of 25 |
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Shortest lunar eclipse in century
Skywatchers all over the world gathered outside Saturday to witness what scientists called the shortest lunar eclipse in a century. -
Amanda Knox and her family celebrate acquittal
Italy's highest court overturned the murder conviction against Amanda Knox and her ex-boyfriend Friday over the 2007 slaying of Knox's roommate, bringing to a definitive end to the high-profile case. -
Hundreds gather to commemorate one-year mark of Oso mudslide
A solemn crowd gathered to honor 43 people who lost their lives a year ago in the deadliest landslide in U.S. history. -
Photos: Oso one year after deadly mudslide
Sunday is the one-year anniversary of the slide, and although most of the mangled cars and homes have been cleaned up, reminders of loss are everywhere.


text:
Customer Reviews for Bali Cordless Semi-Opaque
"very happy"
By willbuymore from Westland
We are very happy with our purchase-6 accordion style blinds. We were worried about how had it was going to be putting them up but it was easy! No flaws with colors. Looks great!
View this product"Great service and blinds"
By customer
Fast response to sample request. Rapid and useful response to customer questions. Excellent instructions. Quality of product and fit is excellent. Bravo!
View this product


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Maybe it's an airway noise while jumping, difficulty performing upper-level dressage movements, or laboring to finish an event. The astute rider will notice different subtleties in his or her horse that might point toward a respiratory issue.
To continue reading this article, become a member of TheHorse.com.
It's FREE and you'll get full access to more than 20,000 articles, video, free reports & more.


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As a surgical pathologist dedicated to the diagnosis and staging of breast tumors, I am involved with the Breast Disease Management Team. This multidisciplinary team comprises a full range of physicians and other specialists and plays a critical role in the case management of breast cancer patients. I conduct research in the diagnosis and pathogenesis of breast disease and assist in training future leaders in breast pathology. My mission is to deliver excellence in service to patients, both present and future, and to continue teaching, diagnosing, and advancing the field of breast pathology.
Breast Pathology
MD, University of Pavia (Italy)
Ospedale di Circolo, Varese (Italy); Massachusetts General Hospital
Massachusetts General Hospital
Anatomic Pathology


text:
Wskazówki dojazdu do Transit Motel Ukonga
Mapa i dojazd
Transit Motel Ukonga is located at the corner of Pugu/ Segerea rds, few minutes drive from Mwl. J Nyerere International Airport. It is about 12km from the city center
Taxi from/to the Airport cost about US$ 5.0.
Taxi from/to city center cost about US$ 20.0
Town busses to the city are available although not recommended.
Airport transfer
We can arrange for an Airport transfer with reliable Airport taxis. The charge is the same as above, payable to the driver. Please send us your flight details if you want this service


text:
2080 Covington Pike
Memphis, TN 38128
Here at Jim Keras Nissan, we know our Memphis area drivers work hard, play hard, and need a car that can keep up. That's why we choose to offer the Nissan lineup at our dealership in Memphis. If you're interested in learning more about your match, stop in to our showroom and treat yourself to a test drive.
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Of course, financing a car is a big investment, and it isn't something that the average consumer does annually - it's a special occasion. With that said, we make sure to provide support for your vehicle years after its left our showroom in Memphis. At our Nissan service and repair center, our friendly professionals match their experience with top-quality auto parts to keep you and your next vehicle together, even longer.
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text:
This Sunday
Wonder how many cameras Bill has set up this time
Jack Gretz
Northeast Music Center 713 Scranton Carbondale Hwy Dickson City Pa 18519
www.nemusiccenter.com 570-909-9216
I don't like the Ravens much, but I'm tired of seeing the Pats and it would be nice for Ray Lewis to finish his career strong, so go Ravens.
Last edited by rugerpc; 01-19-2013 at 05:17 PM.
It'll be the Ravens by 7.
Too bad there has to be a winner because I hate both teams.
I'm rooting for the Pats because Brady went to Michigan.
Hey, gotta root for someone for some reason, so...
I'm rooting for the Pats because I grew up near Boston and I've been rooting for them since it was an exercise in extreme frustration. Seeing them do well year after year never gets old. I have huge respect for their owner, Robert Kraft, who is as good as it gets in pro sports. Ditto TB12. I have a couple of family members who know him personally, in one case quite well. Great person, great football player.
I lived in Cleveland when the Browns skipped town and became the Ravens, so I don't like the Ravens for pulling that. OTOH, I went to HS in Delaware so I like that Flacco has made a name for himself in the NFL after going to that football factory, U of Delaware. And I respect the Ravens players for their toughness and ability to win playoff games on the road. They certainly give the Pats all they can handle and then some every time the two teams tangle.
Ravens all the way, I'm so stoked! Get a chance to right the wrong from the last AFC Championship .
Gotta go with the boys who beat my Bronco's. Go Ravens!
One Life
With a much improved Pats D and the addition of Talib at corner, I don't see the Ravens offense able to generate enough to match the Pats juggernaut. Flacco WILL throw 3 INTs in this game.... I'd bet cash on it.


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Audi increases engine power six-fold for A1 ClubSport Quattro
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The premium Audi A1 sub-compact has won a raft of awards since its launch late last year, scoring five stars in the Euro NCAP crash test and amazed journalists with its frugality of 55.4 mpg and CO2 emissions of just 119 g/km in its most humble 1.2 liter 86 PS TFSI petrol engine version. Which makes the latest version of the A1 to surface somewhat of a surprise – by shoehorning a breathed-upon 503PS, 2.5-liter, five-cylinder TFSI engine into that tiny engine bay, the A1 ClubSport Quattro suddenly boasts six times the power and a whopping 660 Nm of torque, enough to slingshot its diminutive form to 100 km/h in just 3.7 seconds and 200 km/h in 10.9 seconds.
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