text:
|Publication number
|Publication type
|Application number
|Publication date
|Mar 8, 2007
|Filing date
|Aug 15, 2006
|Priority date
|Aug 16, 2005
|Also published as
|Publication number
|Laurent Schaller
|Original Assignee
|Laurent Schaller
|Export Citation
|BiBTeX, EndNote, RefMan
|Referenced by (47), Classifications (42), Legal Events (3)
|External Links: USPTO, USPTO Assignment, Espacenet
This application claims the benefit of U.S. Provisional Application No. 60/708,691, filed Aug. 16, 2005; U.S. Provisional Application No. 60/738,432, filed Nov. 21, 2005; and U.S. Provisional Application No. 60/784,185, filed Mar. 21, 2006, all of which are hereby incorporated herein by reference.
The present invention generally relates to apparatus and methods employed in minimally invasive surgical procedures and more particularly to such apparatus and methods in orthopedic procedures for separating and/or supporting tissue layers.
A variety of physical conditions involve two tissue surfaces that, for diagnosis or treatment of the condition, need to be separated or distracted from one another and then supported in a spaced-apart relationship. Such separation or distraction may be to gain exposure to selected tissue structures, to apply a therapeutic pressure to selected tissues, to return or reposition tissue structures to a more normal or original anatomic position and form, to deliver a drug or growth factor, to alter, influence or deter further growth of select tissues or to carry out other diagnostic or therapeutic procedures. Depending on the condition being treated, the tissue surfaces may be opposed or contiguous and may be bone, skin, soft tissue, or a combination thereof.
One such a condition that occurs in the orthopedic field is vertebral compression fractures. Vertebral compression fractures affect a significant part of the population, and add significant cost to the health care system. A vertebral compression fracture is a crushing or collapsing injury to one or more vertebrae. Vertebral fractures are generally but not exclusively associated with osteoporosis, metastasis, and/or trauma. Osteoporosis reduces bone density, thereby weakening bones and predisposing them to fracture. The osteoporosis-weakened vertebrae can collapse during normal activity and are also more vulnerable to injury from shock or other forces acting on the spine. In severe cases of osteoporosis, actions as simple as bending forward can be enough to cause a vertebral compression fracture. Vertebral compression fractures are the most common type of osteoporotic fractures according to the National Institute of Health.
The mechanism of such vertebral fractures is typically one of flexion with axial compression where even minor events can cause damage to the weakened bone. While the fractures may heal without intervention, the crushed bone may fail to heal adequately. Moreover, if the bones are allowed to heal on their own, the spine may be deformed to the extent the vertebrae were compressed by the fracture. Spinal deformity may lead to breathing and gastrointestinal complications, and adverse loading of adjacent vertebrae.
Vertebral fractures happen most frequently at the thoracolumbar junction, with a relatively normal distribution of fractures around this point. Vertebral fractures can permanently alter the shape and strength of the spine. Commonly, they cause loss of height and a humped back. This disorder (called kyphosis or "dowager's hump") is an exaggeration of the spinal curve that causes the shoulders to slump forward and the top of the back to look enlarged and humped. In severe cases, the body's center of mass is moved further away from the spine resulting in increased bending moment on the spine and increased loading of individual vertebrae.
Another contributing factor to vertebral fractures is metastatic disease. When cancer cells spread to the spine, the cancer may cause destruction of part of the vertebra, weakening and predisposing the bone to fracture.
Osteoporosis and metastatic disease are common root causes leading to vertebral fractures, but trauma to healthy vertebrae can also cause fractures ranging from minor to severe. Such trauma may result from a fall, a forceful jump, a car accident, or any event that compresses or otherwise stresses the spine past its breaking point. The resulting fractures typically are compression fractures or burst fractures.
Vertebral fractures can occur without pain. However, they often cause a severe "band-like" pain that radiates from the spine around both sides of the body. It is commonly believed that the source of acute pain in compression fractures is the result of instability at the fracture site, allowing motion that irritates nerves in and around the vertebrae.
Until recently, treatment of vertebral compression fractures has consisted of conservative measures including rest, analgesics, dietary, and medical regimens to restore bone density or prevent further bone loss, avoidance of injury, and bracing. Unfortunately, the typical patient is an elderly person. As a class of patients, the elderly generally do not tolerate extended bed rest well. As a result, minimally invasive surgical methods for treating vertebral compression fractures have recently been introduced and are gaining popularity.
One technique used to treat vertebral compression fractures is injection of bone filler into the fractured vertebral body. This procedure is commonly referred to as percutaneous vertebroplasty. Vertebroplasty involves injecting bone filler (for example, bone cement, allograph material or autograph material) into the collapsed vertebra to stabilize and strengthen the crushed bone.
In vertebroplasty, physicians typically use one of two surgical approaches to access thoracic and lumbar vertebral bodies: transpedicular or extrapedicular. The transpedicular approach involves the placement of a needle or wire through the pedicle into the vertebral body, and the physician may choose to use either a unilateral access or bilateral transpedicular approach. The extrapedicular technique involves an entry point through the posterolateral corner of the vertebral body.
Regardless of the surgical approach, the physician generally places a small diameter guide wire or needle along the path intended for the bone filler delivery needle. The guide wire is advanced into the vertebral body under fluoroscopic guidance to the delivery point within the vertebra. The access channel into the vertebra may be enlarged to accommodate the delivery tube. In some cases, the delivery tube is placed directly into the vertebral body and forms its own opening. In other cases, an access cannula is placed over the guide wire and advanced into the vertebral body. After placement, the cannula is replaced with the delivery tube, which is passed over the guide wire or pin. In both cases, a hollow needle or similar tube is placed through the delivery tube into the vertebral body and used to deliver the bone filler into the vertebra.
In this procedure, the use of lower viscosity bone filler and higher injection pressures tend to disperse the bone filler throughout the vertebral body. However, such procedures dramatically increase the risk of bone filler extravasation from the vertebral body. The transpedicular approach requires use of a relatively small needle (generally 11 gauge or smaller). In general, the small diameter needle required for a transpedicular approach necessitates injecting the bone filler in a more liquid (less viscous) state. Further, the pressure required to flow bone filler through a small gauge needle is relatively high. The difficulty of controlling or stopping bone filler flow into injury-sensitive areas increases as the required pressure increases. In contrast, the extrapedicular approach provides sufficient room to accommodate a larger needle (up to about 6 mm internal diameter in the lumbar region and lower thoracic regions). The larger needle used in the extrapedicular approach allows injection of bone filler in a thicker, more controllable viscous state. Therefore, many physicians now advocate the extrapedicular approach so that the bone filler may be delivered through a larger cannula under lower pressure. However, the transpedicular approach is still the preferred approach. Caution, however, must still be taken to prevent extravasation, with the greatest attention given to preventing posterior extravasation because it may cause spinal cord trauma. Physicians typically use repeated fluoroscopic imaging to monitor bone filler propagation and to avoid flow into areas of critical concern. If a foraminal leak results, the patient may require surgical decompression and/or suffer paralysis.
Another type of treatment for vertebral fractures is known as Kyphoplasty. Kyphoplasty is a modified vertebral fracture treatment that uses one or two balloons, similar to angioplasty balloons, to attempt to reduce the fracture and, perhaps, restore some vertebral height prior to injecting the bone filler. One or two balloons are typically introduced into the vertebra via bilateral transpedicular cannula. The balloons are inflated to reduce the fracture. After the balloon(s) are deflated and removed, leaving a relatively empty cavity, bone cement is injected into the vertebra. In theory, inflation of the balloons may restore some vertebral height. However, in practice it is difficult to consistently attain meaningful and predictable height restoration. The inconsistent results may be due, in part, to the manner in which the balloon expands in a compressible media, such as the cancellous tissue within the vertebrae, and the structural orientation of the trabecular bone within the vertebra, although there may be additional factors as well.
Thus there is a need for devices and methods to treat the above mentioned diseases, in particular compression vertebral fractures.
Another condition that can be treated by distraction or separation of tissue layers is disruption or degeneration of an intervertebral disk. An intervertebral disk is made up of strong connective tissue which holds one vertebra to the next and acts as a cushion between vertebras. The disk is divided into two distinct regions: the nucleus pulposus and the annulus fibrosus. The nucleus lies at the center of the disk and is surrounded and contained by the annulus. The annulus contains collagen fibers that form concentric lamellae that surround the nucleus. The collagen fibers insert into the endplates of the adjacent vertebral bodies to form a reinforced structure. Cartilaginous endplates are located at the interface between the disk and the adjacent vertebral bodies.
Proper disk height is necessary to ensure proper functionality of the intervertebral disk and spinal column. The disk serves several functions, although its primary function is to facilitate mobility of the spine. In addition, the disk provides for load bearing, load transfer and shock absorption between vertebral levels. The weight of the person generates a compressive load on the disks, but this load is not uniform during typical bending movements. During forward flexion, the posterior annular fibers are stretched while the anterior fibers are compressed. In addition, a translocation of the nucleus occurs as the center of gravity of the nucleus shifts away from the center and towards the extended side.
Changes in disk height can have both local and broader effects. On the local (or cellular) level, decreased disk height results in increased pressure in the nucleus, which can lead to a decrease in cell matrix synthesis and an increase in cell necrosis and apoptosis. In addition, increases in intra-diskal pressure create an unfavorable environment for fluid transfer into the disk, which can cause a further decrease in disk height.
Decreased disk height may also result in significant changes in the overall mechanical stability of the spine. With decreasing height of the disk, the facet joints bear increasing loads and may undergo hypertrophy and degeneration, and may even act as a source of pain over time. Increased stiffness of the spinal column and decreased range of motion resulting from loss of disk height can lead to further instability of the spine, as well as back pain. Radicular pain may result from a decrease in foraminal volume caused by decreased disk height. Specifically, as disk height decreases, the volume of the foraminal canal, through which the spinal nerve roots pass, decreases. This decrease may lead to spinal nerve impingement, with associated radiating pain and dysfunction.
Finally, adjacent segment loading increases as the disk height decreases at a given level. The disks that must bear additional loading are susceptible to accelerated degeneration and compromise, which may eventually propagate along the destabilized spinal column.
In spite of all of these detriments that accompany decreases in disk height, where the change in disk height is gradual many of the ill effects may be "tolerable" to the spine and may allow time for the spinal system to adapt to the gradual changes. However, a sudden decrease in disk volume caused by surgical removal of the disk or disk nucleus can heighten the local and global problems noted above.
The many causes of disruption or degeneration of the intervertebral disk can be generally categorized as mechanical, genetic and biochemical. Mechanical damage can include herniation in which a portion of the nucleus pulposus projects through a fissure or tear in the annulus fibrosus. Genetic and biochemical causes can result in changes in the extracellular matrix pattern of the disk and a decrease in biosynthesis of extracellular matrix components by the cells of the disk. Degeneration is a progressive process that usually begins with a decrease in the ability of the extracellular matrix in the central nucleus pulposus to bind water due to reduced proteoglycan content. With a loss of water content, the nucleus becomes desiccated resulting in a decrease in internal disk hydraulic pressure that ultimately results in a loss of disk height. This loss of disk height can cause non-tensile loading and buckling of the annulus. The loss of disk height also causes the annular lamellae to delaminate, resulting in annular fissures and rupture of the annulus. Herniation may then occur as rupture leads to protrusion of the nucleus.
Many disk defects are treated through a surgical procedure, such as a diskectomy in which the nucleus pulposus material is removed. During a total diskectomy, a substantial amount (and usually all) of the volume of the nucleus pulposus is removed and immediate loss of disk height and volume can result. Even with a partial diskectomy, loss of disk height can ensue.
Diskectomy alone is the most common spinal surgical treatment. The procedure is frequently used to treat radicular pain resulting from nerve impingement by a disk bulge or disk fragments contacting the spinal neural structures.
In another common spinal procedure, the diskectomy may be followed by an implant procedure in which a prosthesis is introduced into the cavity left in the disk space after the nucleus material is removed. Thus far, the most prominent prosthesis is a mechanical device or a "cage" that is sized to restore the proper disk height and is configured for fixation between adjacent vertebrae. These mechanical solutions take on a variety of forms including solid kidney-shaped implants, hollow blocks filled with bone growth material, and threaded cylindrical cages.
A challenge of inserting a disk implant posteriorly is that a device large enough to contact the endplates and slightly expand the intervertebral space between the endplates must be inserted through a limited space. This challenge is often further heightened by the presence of posterior osteophytes, which may cause converging or "fish mouthing" of the posterior endplates that results in very limited access to the disk. A further challenge in degenerative disk spaces is the tendency of the disk space to assume a lenticular shape, which requires a relatively larger implant that often is not easily introduced without causing trauma to the nerve roots. The size of rigid devices that may safely be introduced into the disk space is thereby limited.
Cages of the prior art have been generally successful in promoting fusion and approximating proper disk height. Cages inserted from the posterior approach, however, are limited in size by the interval between the nerve roots. Some examples of prior art devices are shown in U.S. Pat. No. 5,015,247 to Michelson, which describes an artificial threaded spinal fusion implant; U.S. patent application Ser. No. 10/999,727 to Foley et al., which describes vertebral spacer devices for repairing damaged vertebral disks; U.S. Pat. No. 4,309,777 to Patil, which describes a motion preserving implant that has spiked outer surfaces to resist dislocation and contains a series of springs to urge the vertebrae away from each other; and finally, U.S. patent application Ser. No. 10/968,425 to Enayati, which describes an expandable intervertebral prosthesis. All the above patents and patent applications are hereby incorporated herein by reference.
Therefore, a need remains for a device that can be inserted into an intervertebral disk space in a minimally invasive procedure and is large enough to contact and separate adjacent vertebral endplates. There also remains a need for a device that reduces potential trauma to the nerve roots and still allows restoration of disk space height.
Another related area in which tissue distraction may be required is spinal fusion. Fusion is a surgical technique in which one or more of the vertebrae of the spine are united together ("fused") so that motion no longer occurs between them. In spinal fusion surgery, bone grafts are placed around the spine, and the body then heals the grafts over several months—similar to healing a fracture—and joins or "fuses" the vertebrae together.
There are many potential reasons for a surgeon to consider fusing vertebrae, such as treatment of fractured (broken) vertebra, correction of deformity (spinal curves or slippages), elimination of pain from painful motion, treatment of instability, and treatment of some cervical disk herniations.
One of the more common reasons to conduct spinal fusion is to treat a vertebral fracture. Although not all spinal fractures need surgery, some fractures, particularly those associated with spinal cord or nerve injury, generally require fusion as part of the surgical treatment. Certain types of spinal deformity, such as scoliosis, also are commonly treated with spinal fusion. Scoliosis is an "S" shaped curvature of the spine that sometimes occurs in children and adolescents. Fusion can be used as a form of treatment for very large curves or for progressively worsening smaller curves. Additionally, fusion can be used to treat spondylolisthesis, which is a condition that occurs when hairline fractures allow vertebrae to slip forward on top of each other.
Another condition that is treated by fusion surgery is actual or potential instability. Instability refers to abnormal or excessive motion between two or more vertebrae. It is commonly believed that instability can either be a source of back or neck pain or cause potential irritation or damage to adjacent nerves. Although there is some disagreement on the precise definition of instability, many surgeons agree that definite instability of one or more segments of the spine can be treated by fusion.
Cervical disk herniations that require surgery usually need removal of the herniated disk (diskectomy) and fusion. With this procedure, the disk is removed through an incision in the front of the neck (anteriorly) and a small piece of bone is inserted in place of the disk. Although disk removal is commonly combined with fusion in the neck, this is not generally true in the low back (lumbar spine).
Spinal fusion is also sometimes considered in the treatment of a painful spinal condition without clear instability. A major obstacle to the successful treatment of spine pain by fusion is the difficulty in accurately identifying the source of a patient's pain. The theory is that pain can originate from painful spinal motion, and fusing the vertebrae together to eliminate the motion will eliminate the pain.
There are many surgical approaches and methods to fuse the spine, and they all involve placement of a bone graft between the vertebrae. The spine may be approached and the graft placed either from the back (posterior approach), from the front (anterior approach) or by a combination of both. In the neck, the anterior approach is more common and in the lumbar and thoracic regions a posterior approach is usually employed.
The ultimate goal of fusion is to obtain a solid union between two or more vertebrae. Fusion may or may not involve the use of supplemental hardware (instrumentation), such as plates, rods, screws and cages. Instrumentation can sometimes be used to correct a deformity, but it usually is just used as an internal splint to hold the vertebrae together while the bone grafts heal. Whether or not hardware is used, bone or bone substitutes are commonly used to get the vertebrae to fuse together. The bone may be taken either from another bone in the patient (autograft) or from a bone bank (allograft).
Yet another related area in which tissue distraction may be required is in the replacement of essentially an entire or a partially removed vertebra. Such removal is generally necessitated by extensive vertebral fractures, or tumors, and is not usually associated with the treatment of disk disease. Vertebral bodies may be compromised due to disease, defect, or injury. In certain cases, it becomes necessary to remove or replace one or more of the vertebral bodies or disks to alleviate pain or regain spinal functionality.
In the treatment of a removed vertebra, a device is used to form a temporary structural mechanical support that aids in replacing the removed vertebra with bone filler, such as calcium phosphate which promotes healing. A number of methods and devices have been disclosed in the prior art for replacing a diseased or damaged vertebral body. These prior art devices and the procedures associated therewith have difficulty in maintaining the proper structural scaffolding while a castable material, such as bone cement, is hardened in the cavity left by the removed vertebral body. The maintaining of proper structural scaffolding has been especially difficult in a minimally invasive posterior surgical approaches.
Spinal fusion or lumbar spinal fusion is one way to treat a compromised vertebral body due to unstable burst fractures, severe compression fractures, and tumor decompression. In a spinal fusion procedure, the disks above and below the compromised vertebral body are removed and a strut graft and plate are then used to make the vertebrae above and below the replaced vertebral body grow together and become one bone.
Some of the prior art vertebral body replacement systems include U.S. Pat. No. 6,086,613 to Camino et al., which describes an interbody fusion system made of a titanium mesh and endplates; U.S. Pat. No. 5,192,327 to Brantigan, which describes the use of singular or stackable modular implants; U.S. Pat. No. 6,585,770 to White et al., which describes a hollow body with an opening to receive bone growth inducing material; and U.S. Pat. No. 6,758,862 to Berry, which describes a vertebral replacement body device. All of the aforementioned references are hereby incorporated herein by reference.
Thus, there remains a need for improved devices for replacing one or more removed or partially removed vertebral bodies especially from a posterior approach and in a minimally invasive surgical intervention.
The present invention addresses many of the shortcomings in the prior devices and methods by providing a distraction device that separates or distracts tissue layers and maintains such separation.
A first aspect of the invention generally relates to distraction device systems for treating the human spine. The distraction device systems preferably comprise at least one guide member for guiding a generally elongated member to a location between the tissue layers of the spine. The guide member has a proximal end portion and a distal end portion. The distal end portion of the guide member is adapted to be inserted between tissue layers and defines a shape of a desired support structure. The elongated member is slidably mounted on the guide member for advancing the elongated member distally along the guide member to insert the elongated member between the tissue layers. The elongated member substantially conforms to the shape defined by the distal end portion of the guide member to form a support structure that separates, supports or both separates and supports the tissue layers.
Another aspect of the invention relates to distraction systems for treating the human spine. In one embodiment, the distraction system can include at least one guide member for guiding a distraction device to a location between the tissue layers of the spine. The guide member has a proximal end portion and a distal end portion. The distal end portion of the guide member is adapted to be inserted between tissue layers and defines a shape of a multi-tiered support structure. The distraction device is slidably mounted on the guide member for advancing the distraction device distally along the guide member to insert the distraction device between the tissue layers. The distraction device substantially conforms to the shape defined by the distal end portion of the guide member to form a multi-tiered support structure that separates, supports or both separates and supports the tissue layers.
Another aspect of the invention relates to intravertebral distraction systems for the treatment of vertebral defects and injuries, such as compression fracture. In one embodiment, the distraction system generally comprises at least one guide member for guiding a distraction device to a location within a vertebral body. The guide member has a proximal end portion and a distal end portion. The distal end portion of the guide member is adapted to be inserted into the vertebral body and defines a shape of a desired support structure. The distraction device is slidably mounted on the guide member for advancing the distraction device distally along the guide member for insertion into the vertebral body. The distraction device substantially conforms to the shape defined by the distal end portion of the guide member to form a support structure that separates, supports or both separates and supports the superior and inferior endplates.
Yet another aspect of the present invention relates to an intervertebral distraction system insertable between endplates of a superior vertebra and an inferior vertebra. In one embodiment, the distraction system comprises at least one guide member for guiding a distraction device to a location between a superior vertebra and an inferior vertebra. The guide member has a proximal end portion and a distal end portion. The distal end portion of the guide member is adapted to be inserted between the superior and inferior vertebrae and defines a shape of a multi-tiered support structure. The distraction device is slidably mounted on the guide member for advancing the distraction distally along the guide member for insertion between the superior and inferior vertebrae. The distraction device substantially conforms to the shape defined by the distal end portion of the guide member to form a multi-tiered support structure that separates, supports or both separates and supports the superior and inferior vertebrae.
These and other aspects of the present invention are set forth in the following detailed description. In that respect, it should be noted that the present invention includes a number of different aspects which may have utility alone and/or in combination with other aspects. Accordingly, the above summary is not exhaustive identification of each such aspect that is now or may hereafter be claimed, but represents an overview of the present invention to assist in understanding the more detailed description that follows. The scope of the invention is as set forth in the claims now or hereafter filed.
In the course of this description, reference will be made to the accompanying drawings, wherein:
Turning now to a detailed description of illustrated embodiments of the present invention. The apparatus or device of the present invention, which is generally defined as a distraction device, can serve to actively separate tissue layers by engaging them and forcing them apart, or to support the separation of tissue layers separated by the distraction device itself or by other devices or processes or a combination of these. Accordingly, the term "distracting device" is intended to have a general meaning and is not limited to devices that only actively separate tissue layers, only support tissue layers or only both actively separate and support tissue layers. For example, the distraction device in general can be used to actively separate layers of tissue and then be removed after such separation, or the distraction device could be used to support layers of tissue that have been previously separated by a different device. Alternatively, the distraction device can be used to actively separate the layers of tissue and remain in place to support the layers of tissue in order to maintain such separation. Unless more specifically set forth in the claims, as used herein, "distraction device" encompasses any and all of these.
It should also be understood that various embodiments of the device, system and method of the present invention are illustrated for purposes of explanation in the treatment of vertebral compression fractures, height restoration of a diseased disk, vertebral fusion procedures and/or replacement of removed disks or vertebra. However, in its broader aspects, the present invention is not limited to these particular applications and may be used in connection with other tissue layers, such as soft tissue layers, although it has particular utility and benefit in treatment of vertebral conditions.
When deployed between tissue layers, as shown in
Preferably, the support structure 141 includes or defines an innerspace or resident volume 145. As used herein, "resident volume" refers generally to a structural characteristic of the support structure. The resident volume is a volume that is generally defined by the distraction device, when it is in the deployed configuration. The resident volume is not necessarily a volume completely enclosed by the distraction device and can be any volume generally defined by the distraction device. This term does not necessarily mean that the resident volume is an open or void volume or cavity and does not preclude a situation in which the resident volume is, at some point in time, filled with another material, such as bone filler, cement, therapeutic drugs or the like. It also does not preclude the resident volume from containing undisturbed human tissue that is located or remains within the resident volume during or after deployment of the distraction device, as will be explained in more detail below. For example, if the distraction device is employed to separate adjoining soft tissue layers, such as subcutaneous fat and underlying muscle tissue, the resident volume of the distraction device may be hollow or void of tissue after separation. On the other hand, if inserted into a vertebra having cancellous bone tissue therein, the resident volume will contain undisturbed bone tissue and no void or cavity is formed by the distraction device.
In order to shape the distraction device 136 like a coil or spring, it is helpful to understand the characteristics of a shape memory alloy. Nickel-Titanium alloys, such as Nitinol, exhibit the phenomena of thermal shape memory and superelasticity. The term thermal shape memory refers to the material's ability to return from a plastically deformed shape to a pre-determined shape upon increasing the temperature of the material. The term superelasticity refers to the elastic ability of the material. Materials with superelastic characteristics can be deformed by applying a force to constrain the material in a deformed or constrained shape. Once the force or constraint is removed, the material will substantially return to its pre-determined or initial shape. Superelastic materials, such as Nickel-titanium alloys, can be considerably more elastic than stainless steel. The pre-determined or initial shape can be referred to as the free state and the deformed shape can be referred to as the constrained state.
The initial or pre-determined shape of a shape memory material is normally set by a heat treatment process, which is well known in the art. In the present invention, the material selected is wound on a mandrel and securely attached so it can be heat treated to set the desire shape, in this case, to be configured like a tight pitch coil or helical shape. The heat cycle is typically around 500� C. and for a period of 10 minutes to 60 minutes depending on the strength of the material, spring constant and oxide layer required. The mandrel could range in sizes from about 0.125 to about 2.0 inches, but is preferably around 0.5 inches in diameter. The wind direction could be right hand or left hand, with a tight pitch, having little or no space between adjacent coils or turns. However, other pitches could be used if required by the application, and if the material is of sufficient strength, the coils can be spaced apart.
Because of the shape memory characteristics of the material used in the construction of the distraction device 136, the distraction device can be deformed prior to or during delivery to a desired treatment site, and then returned to its original shape within the treatment site. In other words, the distraction device has an inherent tendency or is predisposed to form itself into its deployed shape. Referring to
The cannula 142 preferably has a lumen 143 and a bore 144 that is complementary to or the same as the cross-section of the distraction device 136. The distraction device 136 can be pushed or pulled through the cannula 142 with the aid of a pushrod 150 or other suitable advancement device. The proximal end 152 of the cannula 142 may have a knob or handle 154 or other structure for ease of use and a proximal end 156 of the pushrod 150 also may have a knob or handle 158 as well.
As shown in
In a typical procedure for treatment of a vertebral compression fracture, access to the vertebra can be gained by using the same procedures and techniques that are used for the other vertebral procedures mentioned above, or by any other procedures and techniques generally known by those skilled in the art. Referring to
The distraction device 136 may be prepositioned within the cannula 142, which constrains the distraction device in the deformed or pre-deployed configuration. As the pushrod 150 is advanced, the distraction device 136 is advanced out of the distal end portion 146 of the cannula 142 and into the cancellous bone 108 of the vertebral body 130. Upon exiting the cannula 142, the distraction device 136 will begin to revert, by change of configuration, to its initial or deployed coil shape to define support structure 141. Thus, as it is advanced from the cannula, the distraction device 136 winds up into the relatively spongy cancellous bone 108 of the vertebral body 130 as shown in
As deployment of the distraction device 136 progresses into the cancellous bone 108 between the endplates 112, 114, in this embodiment, the spring-shaped distraction device support structure 141 will contact the endplates and start to distract the endplates (or actively separate them) apart from each other as the support structure increases in height. The distraction device 136 will be advanced out of the cannula 142 until the distraction device attains the desired height or extent as measured in the direction of endplate separation, or the endplates 112, 114 have been separated by a desired distance. Typically, the distraction device 136 is advanced until the height of the distraction device support structure 141 is such that it returns the endplates 112, 114 to a normal pre-compression position, or such other spacing as the physician deems appropriate as illustrated in
In one embodiment of the present invention, the height of the vertebra is estimated prior to the procedure by measuring adjacent vertebrae, and then an appropriate sized distraction device that will achieve the desired height upon completely exiting the cannula is selected. Alternatively, the height of the distraction device could be monitored during the procedure, and when the desired height is attained, the distraction device ("ribbon") could be severed at a location near the distal end of the cannula.
Another optional and beneficial aspect of the distraction device of the present invention is the ability to control the delivery of flowable material, such as bone filler, for example bone cement, allograph, autograph or some other biocompatible material, or therapeutic drug into the treatment site. One example of an appropriate bone filler is polymethyl methacrylate (PMMA), commercially available as Kyphx HV-R from Kyphon, Spineplex from Stryker, Simplex from Stryker Howmedica and Parallax Acrylic Resin with Tracers TA from Arthocare. The distraction device also can be used to control the delivery of drugs or other agents or fluids, depending on the application.
For example, once the support structure 141 defined by the distraction device is in place, bone filler 162 can be introduced into the treatment site to assist in stabilization of the distraction device and to aid in supporting the separation of the endplates 112, 114. As illustrated in
The distraction device can have a variety of the cross-sectional profiles configurations, as shown in
If desired, the distraction device 136 a can include lateral grooves or slots 170 or other lateral passageways at strategic locations. These grooves 170 or other passageways may be formed by drilling, cutting, grinding or compressing the distraction device material. When the distraction device is made of a shape memory material, the grooves or passageways can be formed either before or after winding and heat treating. The grooves 170 can be uniformly or randomly spaced apart and, depending on the desired treatment, located only on one side of the support structure defined by the distraction device. The grooves 170 can be used to direct and limit the flow of bone filler injected into and around the treatment site. For example, as illustrated in
The distraction device could also include apertures or holes 182 which extend through the wall 180 and communicate with the internal bore or channel 178. The apertures 182 can be uniformly or randomly spaced apart and may be of the same size or vary in size. Additionally, the apertures 182 could be limited to the inner wall of the distraction device or to the outer wall of the distraction device or could be located on both the inner and outer walls. Further, the apertures 182 could be limited to one side of the distraction device, such as on the anterior side or posterior side. Bone filler can be delivered to the treatment site by inserting the tip of the syringe into the channel 178 and injecting the bone filler into the channel. The bone filler will flow along the channel 178 and escape out of the apertures 182 in the desired directions into the treatment site. The location and arrangement of the apertures will determine the direction of bone filler injected within the treatment site.
The distraction device also may be coated with a polymer based of bone filler material that can be activated upon implantation and diffused into the surrounding tissue. This potential feature is applicable to a distraction device of any cross-sectional shape.
The distraction devices of the present invention may also be used in intervertebral disk treatments and intervertebral body fusion procedures, as well as, total or partial vertebral body replacements procedures. One of the advantages of the present invention is the ability to use the device in a minimally invasive surgery setting that allows the surgeon to use an endoscopic approach to remove damaged spinal tissue due to disease, such as trauma or tumor and to deploy the device into the space created by such removal.
In one minimally invasive method of an intervertebral disk treatment or intervertebral body fusion procedure in accordance with the present invention, a disk nucleus removal tool 190, such as rongeurs, curettes, probes or dissectors, is inserted through a small access hole 191 in the annulus fibrous 192 of an intervertebral disk 193, as illustrated in
Referring to
In a procedure in which the distraction device 136 is designed to be advanced completely out of the cannula 142, the desired height of the support structure 141 is pre-determined and a distraction device of an appropriate size is chosen for use. In a procedure in which the distraction device 136 is deployed until the desired height of the support structure 141 is attained, the height of the support structure may be monitored under fluoroscopy, and once the support structure has reached the desired height, the distraction device may be severed at a location near the distal end portion of the cannula.
Upon deployment, the distraction device restores disk height and stabilizes the vertebral column. Depending on the amount of nucleus pulpous tissue removed and the deployment location of the support structure, the resident volume of the support structure may be substantially empty or may contain some nucleus pulpous tissue. Optionally, bone filler, such as bone cement, allograph or autograph, or other therapeutic drugs may be inserted into the resident volume defined by the support structure and/or around the support structure to aid in stabilization of the device and/or to promote bone fusion between the adjacent vertebrae.
The prior art device illustrated in
In one minimally invasive partial VBR procedure of the present invention, a vertebral bone removal tool 197 is inserted through a small access hole 160 c of a vertebral body 130 c as illustrated in
Referring to
In one minimally invasive method of a total VBR procedure, the vertebral body removal tool described above is used to move substantially all of a vertebral body, and optionally, a disk removal tool is used to substantially remove the adjacent disks. Referring to
The deployed support structure 141 provides support and stabilizes the vertebra column. Optionally, bone filler or therapeutic drugs may be inserted into the resident volume and around the support structure to stabilize the support structure and/or to promote bone fusion.
The distraction device 202 is preferably made from biocompatible materials that are suitable for long term implantation into human tissue in the treatment of degenerative tissue, trauma or metastatic conditions or where a tissue distraction device is needed. The material used may also be a biological material such as, Calcium Phosphate, Tricalicum Phosphate, Hydroxyapatite, or any other suitable biological material. The biocompatible materials may be PEEK (polyetheretherketone), Nylon, NiTi or any other suitable. The material may be solid or porous for tissue ingrowth, and may elute therapeutic or growth enhancing agents. One of the advantages of using biological or biocompatible material to treat vertebral compression fractures is that these elements have a more natural like substance. However, other materials could be used and still be within the scope of the present invention.
The guide wire 200 includes a proximal end portion 204 and a distal end portion 206. The distal end portion, in a deployed state, preferably defines a multi-tiered arrangement, scaffolding or platform, such as the illustrated coil or helical shape with a plurality of stacked windings, as shown in
A small knob 212 can be mounted at the proximal end portion 204 of the guide wire 200 to provide a gripping portion. The knob 212 can be held with one hand as the pusher 208 is advanced distally along the guide wire 200, indicated by arrow D in
It should therefore be apparent from the above that the present invention is particularly advantageous and conducive to minimally invasive surgical procedures for treatment of the spine. In accordance with this aspect of the present invention only a single access opening is required, which may be made transcutaneously and through the appropriate spinal bone or other tissue. Through this single opening a relatively large three-dimensional support structure can be built within the confined space of an individual vertebra or between adjoining vertebrae. Insertion of the distraction device may be aided by an introduction cannula or sheath, or the distraction device itself may be directly advanced through an access opening without the need for a cannula or other advancing aid. In any event, in the illustrated embodiment a relatively large support structure is built or formed in situ through a relatively much smaller access opening, providing the benefits of more drastic and invasive surgical approaches with the safety and ease of minimally invasive techniques.
As explained above, the guide wire 200 is preferably made of a shape memory material that has an initial or free state in the shape of a coil or spring. As the guide wire 200 is inserted into the cannula 224, the cannula constrains the guide wire into a generally elongated linear configuration, allowing an easy and minimally invasive deployment of the guide wire into the treatment site. Because of the shape memory properties, the guide wire 200 will return to its coil-shaped free state once the constraint is removed, i.e., as the guide wire exits the distal end portion 225 of the cannula 224 and enters the vertebral body 222. The guide wire 200 can be advanced through the cannula 224 manually or with the aid of an advancing mechanism, such as a ratcheting mechanism, e.g., the ratchet gun shown in
In order to improve the rate and ease of penetration of the guide wire 200 through bone and other tissues, an energy system can be operatively connected to the guide wire to transmit energy that enables the tip of the wire to drill through the tissue or bone to access the desired site or obtain the desire configuration. In the illustrated embodiment, the proximal end portion 204 of the guide wire 200 can be coupled to an energy system, such as a transducer assembly 226 with a piezoelectric element that produces ultrasonic vibrations at a specific frequency to help the guide wire penetrate the bony structure of the vertebral body. Such energy system could include an energy source 228 coupled to the transducer 226 capable of propagating ultrasonic energy at frequencies suitable for drilling a pathway into dense material, such as bone. The use of such energy systems that may be employed in the present invention are described in U.S. Pat. No. 6,498,421 to Oh which discloses drilling, U.S. Pat. No. 6,899,715 to Beaty which discloses boring and U.S. Pat. No. 4,838,853 to Parisi which discloses cutting using ultrasonic energy. Such devices have also been used in the vascular system to penetrate through arterial blood clots as described in U.S. Pat. No. 6,929,632 to Nita. All of the aforementioned patents are hereby incorporated herein by reference.
It will be understood that the energy system as described herein can also be used in a substantially similar manner to aid in the delivery of the above described distraction device 136 of
As the guide wire 200 exits the distal end portion 225 of the cannula 224 and enters the vertebral body 222, the distal end portion 206 of the guide wire begins to return to its unconstrained shape, i.e., the distal end portion of the guide wire begins to wind into its coil shape. Referring to
Referring to
One of the advantages of removing the introducer sheath and the cannula from the system is that such removal allows for a larger passageway into the vertebral body. The larger passageway makes it possible to employ distraction devices or implants having larger dimensions. Thus, when the introducer sheath and cannula are removed, the dimensions of the distraction device can be larger because the size of the distraction device is not constrained or controlled by the size of the introducer sheath or cannula. One advantage of employing a larger distraction device is that the larger distraction device provides a larger surface area that disperses the loading forces acting on the device and results in less pressure being placed on any given portion of the device or on the surface of the vertebral body contacted by the distraction device.
As illustrated in
Referring to
In the vertebral body, the distraction device 202 follows along the coiled shaped portion 206 of the guide wire 200 and winds into a coil shaped support structure 216 as shown in
One advantage of this embodiment of the distraction device, as noted above, is that it can be inserted through a small access hole and a much larger three dimensional support structure, such as a multi-tiered arrangement or scaffolding, can be built within a limited or confined space between or within the tissue layers. For instance the distraction device 202 can be inserted through a small access hole and the support structure 216 can be built one loop at the time by adding one thickness of the distraction device over another one. As an example, the average vertebral body is 18 mm in height. As illustrated in
After the distraction device 202 has been deployed, the guide wire 200 can be retracted from the distraction device and removed from the system. This can be accomplished by holding the pusher member 208 in place while retracting the guide wire 200 in a proximal direction. For example, the guide wire 200 can be retracted proximally by reversing the advancing mechanism, e.g., the ratchet mechanism of the delivery gun, while keeping the pusher member in place.
The distraction device of the present invention is preferably but not exclusively used with bone filler material to add stability to the distraction device and support between the distracted tissue, i.e., the endplates of the vertebra. Bone filler may be introduced in a variety of ways. As illustrated in
The distraction device may have a variety of configurations without departing from the present disclosure. The different configurations provide a variety of advantageous features of the distraction device. One aspect to be considered in regards to an implanted distraction device is the ability of the device to resist different forces, such as compressive and axial forces. It is easily understood that the device can resist compressive loading wherein the force on the distraction device is axial. However, additional lateral or translation forces can also act on the device when the body is moving.
The size and dimension of the distraction device when used for the treatment of vertebral compression fracture is preferably of a size that can be inserted through a cannula no larger that about a 6 gauge size (working diameter about 0.173 inches (about 4.39 mm)) which would allow the distraction device to have a generally square profile of about 0.118 inches�0.118 inches (about 3 mm�3 mm). Other sizes and dimensions could be used depending on the application. The length of the distraction device could be pre-determined or could be cut to fit during the treatment.
The construction of the distraction device could be accomplished using several techniques known in the art, including but not limited to molding, machining or extruding. It is also understood that the delivery coil or guide member could have different profiles and different shapes according to the application requirements.
In one embodiment, referring to
The distraction device also can be constructed by linking a plurality of individual distraction device elements together to form a chain-like structure. For example, a thin section of material could be connected to a plurality of cube-like distraction device elements to retain all of the elements together, forming a line or deformable linear structure. The individual distraction device elements can be similarly sized and shaped, or alternatively, each individual element can be a different size and shape.
Alternatively, the distraction device can be formed from a bar or rod shaped in which a multitude of slots that can be machined into the starting bar or rod at regular or random intervals. A channel may be bored through the middle of the distraction device for mounting and sliding onto a guide wire.
The distraction devices and guide wires of the present invention can be deployed by a variety of different methods and with a variety of apparatus. It will be understood that the deployment methods and apparatus disclosed in
The distraction device may be made more effective for certain procedures by using multiple coil or spring-shaped distraction devices in order to speed up the procedure and also increase the surface area in contact with the tissue or endplates in the case of treating vertebras. In circumstances where smaller distraction devices are used, but the surgeon desires to have the maximum surface area to support the two endplates of a vertebra, the surgeon can used a bi-transpedicular approach for instance as shown in
A double coil or distraction device having a superior device 268 and an inferior device 270 is also shown in
Another configuration of a double coil or device design is shown in
In order to both reduce delivery time and double the surface contact area, another distraction device configuration is illustrated with four distraction devices in
In addition to a manual pushrod advance of the distraction device, semi-automated or automated apparatus may be provided for ease of use.
Another device and method to deliver the distraction device are illustrated in
As noted above, the present invention relates to devices and methods to treat a condition that requires skin, tissue, organ, bone or a combination of those to be distracted from one another and supported apart of each other, either on a permanent situation or a temporary situation. It is also more specifically applicable for the treatment of vertebral compression fractures. The distraction device is also particularly well suited for the treatment of intervertebral disk treatments and spinal fusion.
Referring to
In one preferred method of delivering a distraction device in accordance with the present invention, referring to
As illustrated in
Once the distraction device has achieved the desired deployment, the delivery wire 316 can be removed leaving the support structure 313 in place as shown in
An alternate deployment method in accordance with the present invention is illustrated in
As illustrated in
After the distraction device 324 a has formed the support structure 313 a, if there are excess portions of the distraction device, the excess portion may be severed and removed. In other words, the distraction device can be cut to length after deployment. One of the advantages of being able to cut the distraction device to length is that a single distraction device is capable of being deployed over guide wires of different radii, lengths and coil or deployment configurations.
As shown in
The previous methods have been described for a posterior access to the spine. However, in some situations, especially in the lumbar region, an anterior approach is desired.
In the situation where the end plates of the adjacent vertebra are not parallel it may be preferable to use a distraction device that forms a support structure having oblique ends.
One advantage of an oblique configuration is that it can be used with a posterior approach as illustrated in
The distraction device having an oblique configuration can be formed from the distraction device ribbon 349 as illustrated in
The distraction devices of the present invention can also be used for total or partial vertebral body replacements (VBR). In one minimally invasive partial VBR procedure of the present invention, an endoscopic procedure, generally similar to the procedure described above with respect to
As the guide wire 404 exits the distal end portion 408 of the cannula 400 and enters the vertebral body 406, the distal end portion 410 of the guide wire begins to return to its unconstrained coiled shape. The guide wire 404 is advanced and deployed into the vertebral body until the coil shape reaches a desired height or has the desired number of windings 412.
After the guide wire 404 has achieved a desire deployment configuration, optionally, the cannula 400 can be retracted and removed from the system. At this stage, the coiled distal end portion 410 of the guide wire 404 is deployed within the vertebral body 406, and the proximal end portion 414 of the guide wire is extending out of the passageway 408. The proximal end portion 414 of the guide wire defines an insertion path for the distraction device 416, as illustrated in
The distraction device 416 is inserted over the proximal end portion 414 of the guide wire 404, and a pusher member 418 is placed over the guide wire behind or proximal the distraction device. As the pusher member 418 is advanced, it contacts the distraction device 416 and advances it forward or distally over the guide wire 404.
In the vertebral body, the distraction device 416 follows along the coiled shaped portion 410 of the guide wire 404 and winds into a coil shaped support structure 420. With each formation of an additional coil or winding 422 of the support structure 420, the support structure increases in height or extent. As the support structure 420 increases in height, it distracts and supports the endplates 424, 426 of the vertebra, restoring or partially restoring vertebral height and stabilizing the vertebral body 406.
After the distraction device 416 has been deployed, the guide wire 404 can be retracted from the distraction device and removed from the system. Alternatively, the guide wire 404 could be severed and left within the distraction device 416. Optionally, bone filler such as bone cement, allograph or autograph, or therapeutic drugs may be inserted in or around the device, by similar methods described above, in order stabilize the device and/or to promote bone fusion.
In one minimally invasive method of a total VBR procedure, the vertebral body removal tool described above can be used to remove substantially all of the vertebral body of a vertebra 401, and a disk removal tool can used to substantially remove the adjacent disks. Referring to
After the guide wire 404 a has achieved a desired deployment configuration, the cannula 400 a can be retracted and removed from the system. Referring to
After the distraction device has been deployed, optionally, bone filler, such as bone cement, allograph or autograph, or therapeutic drugs may be inserted in or around the support structure to stabilize the support structure and/or to promote bone fusion.
Although the present invention is described in light of the illustrated embodiments, it is understood that this for the purposes illustration and not limitation. Other applications, modifications or use of the support or distraction device may be made without departing for the scope of this invention, as set forth in the claims now or hereafter filed.
|Citing Patent
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|Jul 1, 2005
|Oct 28, 2008
|Jerome Segal
|Mechanical apparatus and method for artificial disc replacement
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|Benvenue Medical, Inc.
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|Aug 15, 2006
|Feb 23, 2010
|Benvenue Medical, Inc.
|Devices for limiting the movement of material introduced between layers of spinal tissue
|Aug 15, 2006
|Mar 2, 2010
|Benvenue Medical, Inc.
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|Aug 15, 2006
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|Methods for limiting the movement of material introduced between layers of spinal tissue
|Dec 9, 2005
|Mar 23, 2010
|Spinal Ventures, Llc
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|Aug 31, 2010
|Benvenue Medical, Inc.
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|Feb 15, 2010
|Jun 7, 2011
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|Feb 15, 2010
|Jun 21, 2011
|Benvenue Medical, Inc.
|Methods of distracting tissue layers of the human spine
|Feb 15, 2010
|Jun 28, 2011
|Benvenue Medical, Inc.
|Spinal tissue distraction devices
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|Jun 28, 2011
|Benvenue Medical, Inc.
|Devices for limiting the movement of material introduced between layers of spinal tissue
|Dec 16, 2008
|Aug 2, 2011
|Matthew Yurek
|Mechanical apparatus and method for delivering materials into the inter-vertebral body space for nucleus replacement
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|Sep 6, 2011
|Spineology, Inc.
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|Jun 15, 2005
|Sep 20, 2011
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|Alphatec Spine, Inc.
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|Apparatus and method for treating bone
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|Sep 17, 2013
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|Nov 15, 2011
|Oct 15, 2013
|Benvenue Medical, Inc.
|Devices and methods for treating the vertebral body
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|Nov 26, 2013
|Benvenue Medical, Inc.
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|Jul 2, 2012
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|Nuclear implant
|Nov 12, 2009
|May 27, 2014
|Spinal Ventures, Llc
|Device and method for securing a fastener
|Jun 16, 2011
|Aug 12, 2014
|Benvenue Medical, Inc.
|Methods of distracting tissue layers of the human spine
|Mar 25, 2009
|Aug 19, 2014
|Benvenue Medical, Inc.
|Intravertebral implants
|Jun 22, 2012
|Aug 26, 2014
|Benvenue Medical, Inc.
|Devices and methods for treating bone tissue
|Dec 18, 2012
|Nov 11, 2014
|Benvenue Medical, Inc.
|Apparatus and method for treating bone
|Sep 29, 2012
|Dec 30, 2014
|Rex Medical, L.P.
|Spinal implant and method of use
|Sep 26, 2013
|Feb 24, 2015
|Benvenue Medical, Inc.
|Devices for distracting tissue layers of the human spine
|Apr 24, 2013
|Mar 3, 2015
|Benvenue Medical, Inc.
|Devices for treating the spine
|Jun 16, 2011
|Mar 17, 2015
|Benvenue Medical, Inc.
|Spinal tissue distraction devices
|Mar 12, 2013
|Jun 2, 2015
|Benvenue Medical, Inc.
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|Dec 10, 2012
|Jun 16, 2015
|Mazor Robotics Ltd.
|Segmented insert for intervertebral support
|Feb 20, 2009
|Jun 30, 2015
|Benvenue Medical, Inc.
|Method of interdigitating flowable material with bone tissue
|Jun 22, 2007
|Aug 4, 2015
|Rex Medical, L. P.
|Method of inserting a spinal implant
|Dec 9, 2005
|Aug 17, 2006
|Zwirkoski Paul A
|Non-soft tissue repair
|Nov 14, 2005
|Dec 21, 2006
|Jerome Segal
|Mechanical apparatus and method for artificial disc replacement
|Feb 22, 2006
|Dec 21, 2006
|Jerome Segal
|Mechanical apparatus and method for artificial disc replacement
|Oct 6, 2011
|Kitchen Michael S
|Intervertebral spacer and methods of use
|May 10, 2012
|Kuslich Stephen D
|Semi-biological intervertebral disc replacement system
|Nov 1, 2012
|Nuclear implant
|Nov 15, 2012
|Synthes Usa, Llc
|Flexible elongated chain implant and method of supporting body tissue with same
|Sep 29, 2012
|Jan 31, 2013
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|Spinal implant and method of use
|Dec 10, 2012
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|Dec 6, 2014
|Apr 2, 2015
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|U.S. Classification
|International Classification
|Cooperative Classification
|European Classification
|Mar 1, 2007
Owner name: BENVENUE MEDICAL, INC.,CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SCHALLER, LAURENT;REEL/FRAME:018948/0220
Effective date: 20070301
|Dec 7, 2010
|Certificate of correction
|Mar 1, 2013
|Fee payment
Year of fee payment: 4


text:
The 13th generation of the #1 Cabretta leather glove in golf is packed full of Tour Proven Performance technologies and hand-sewn craftsmanship to give players of all abilities the competitive edge.
FootJoy®, the #1 Glove in Golf, today introduces the latest iteration of its iconic FJ StaSof® glove, the world's #1 Cabretta leather glove for over 35 years. Featuring a myriad of features and benefits, for golfers of all abilities, the all-new StaSof has been masterfully-crafted to produce a sensationally soft and comfortable feel, precision tailored fit and unmatched grip and durability in all playing conditions.
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Constructed from premium Taction2®Advance Performance (APL™) Cabretta Leather, the new StaSof provides improved tour-tested performance due to a number of new features, including the softer, thinner elastic that contours the glove to the hand for a lightweight feel, improved fit and comfort. A single stitch PowerNet™ mesh and strategically placed perforations also create a more comfortable feel and fit across the knuckles.
"The original StaSof glove set the benchmark when it was introduced over 35 years ago, but thanks to our exclusive partnership with Pittards®, continuous product innovation and a relentless pursuit of the finest materials, the StaSof to this day maintains its status as the #1 Cabretta leather glove on Worldwide Tours," said Maria Bonzagni, Senior Director of Marketing, FJ Gloves and Accessories.
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As the #1 Cabretta leather glove in golf, StaSof is trusted on tour by the best players in the game including the following FJ brand ambassadors: 2015 British Open Champion Zach Johnson, 2013 Masters Champion Adam Scott, defending FedEx Cup champion Billy Horschel and Ryder Cup stars, Jimmy Walker and Lee Westwood among many others.
The new StaSof is available in an impressive 26 size options, ensuring an all-encompassing provision of Men's Left, Cadet & Right as well as Women's Left & Right sizes. The new StaSof is available in both Pearl and Black colors to give greater standout appeal to this iconic product.
Whether it is the #1 Cabretta leather glove in golf, the all-new StaSof®, the vibrant colors of FJ Spectrum®, the customized cool fit of StaCool®, the powerful grip and moisture resistance of SciFlex® Tour, the precision fit of GTxtreme®, the long-lasting properties of WeatherSof® or the advanced wet-weather capabilities of RainGrip® and WinterSof ®, FJ remains the overwhelming choice for golfers of all abilities around the world.
NO PURCHASE NECESSARY. This Sweepstakes will begin at 12:01a.m. ET on August 31, 2015 and end at 11:59 p.m. ET on October 4, 2015. Void where prohibited. Open to US residents 18 years or older.
JJ Henry edged Kyle Reifers on the second hole of sudden death with an eagle to take the Barracuda Championship. Henry racked up 47 points in the modified stableford format. Players received eight points for double eagle, five for eagle, two for birdie, zero for par, minus-one for bogey and minus-three for double bogey or worse.
This is Henry's third PGA Tour victory and second win at the Barracuda Championship.
Henry relied on DryJoys Tour en route to the win.
Barracuda Championship Shoe Count
Nearest Competitor - 17%
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NO PURCHASE NECESSARY. Void where prohibited. Open to US residents 18 years or older. Sweepstakes will begin at 12:01AM ET on 8/10/2015 and end 8/13/2015 at 11:59PM ET.
Troy Merritt won the Quicken Loans National thanks to a final round four under par 67. Merritt's 18-under par total was three strokes clear of the field. This is Merritt's first PGA Tour victory.
Merritt relied on FJ Icon Black golf shoes and the new SciFlex Tour golf glove.
"It was really nice coming down that final fairway with a two-shot lead," said Merritt post round. "Not feeling very much stress, just trying to make as good of a golf swing as I could and, as you saw, it was nice to have only one putt.
FJ Wins, You Win - Click here for your chance to win a pair of FJ Icon Black golf shoes and a SciFlex Tour golf glove.
NO PURCHASE NECESSARY. Void where prohibited. Open to US residents 18 years or older. Sweepstakes will begin at 12:01AM ET on 8/3/2015 and end 8/6/2015 at 11:59PM ET.
Zach Johnson emerged victorious from a three man FJ playoff in the 144th playing of the Open Championship!
Needing a birdie on the final hole of regulation to take the clubhouse lead at 15-under par, Johnson sank 20 plus foot putt and watched as his playing competitors tried to catch him. Louis Oosthuizen and Marc Leishman were able to do so and the three golfers headed to a four hole aggregate playoff to determine the champion.
On the first hole, Oosthuizen and Johnson carded birdies. Johnson poured in a second birdie putt on the following hole to take the lead over Oosthuizen and Leishman. On the treacherous road hole each player made bogey. Now on the 18th tee with a one stroke lead, Johnson hit the wide 18th fairway and pitched his ball safely beyond the pin. Johnson's birdie putt slid by the hole and he tapped in for par. Oosthuizen had a chance to tie, but his putt slid by giving Johnson the victory.
Each player in the playoff relied on a model from our DryJoys Lineup. Zach led the way in DryJoys Tour MyJoys, Louis in DryJoys Casual and Marc in D.N.A. Each player also relied on FJ golf gloves during their Open perfornance, Johnson and Lieshman in StaSof and Oosthizen in SciFlex Tour.
This is Johnson's second major victory.
FJ Wins, You Win - Click here for your chance to win a pair of DryJoys Tour golf shoes, a StaSof golf glove, and DryJoys Tour XP Rain Pants!
NO PURCHASE NECESSARY. Void where prohibited. Open to US residents 18 years or older. Sweepstakes will begin at 12:01AM ET on 7/20/2015 and end 7/23/2015 at 11:59PM ET.
This week our European Tour Staff seeded our tour players with an new light blue and navy HYPERFLEX and the players quickly took to social media to show them off. We quickly began receiving questions when they will be available in the U.S. At this time, they will be a Europe-only release.
However, we did manage to get our hands on 5 pair and are excited to offer them to our Community members!
How do you enter to win these shoes? Simply tell us, given the opportunity to play at St. Andrews this weekend, what you think you would shoot? Remember the weekend forecast will be a little rough!
REMINDER : To enter you must have a community profile. If you do not have one, click here to register for the FJ Community - http://www.footjoy.com/myaccount/register
FIVE winners will be randomly selected on 7/20/15. Deadline for entry is 12:00 pm ET on 7/19/15. Void where prohibited. Open to US residents 18 years or older. For additional rules and regulations click here.
UPDATE: The winners have been selected and notified via email: rusty123, vettengineer, mtiger10, NCbob, and jrnes2

subset: commoncrawl


text:
Programs for High School Students
Great news for high school seniors! You can study abroad with AIFS on several programs offered during the summer.
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AIFS programs that accept high school graduates
|Academic Year and Semester Programs
|Summer Programs
You can apply online (recommended for quick decision) or by mail.


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- Product Details
- Click Here to View All Washington Redskins X-Mas and Figurines
Decorate your table with this Snowman Table Runner. 72" long by 15" wide, this plush table runner features a snowman parent and child at each end dressed in your favorite team's colors, along with the team logo and embroidered stars. Add the Table Top Snowman Family to complete the look!
Additional Information
|This Item Usually Leaves The Warehouse In
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text:
This medication is used to treat nausea and vomiting that can occur following surgery or with certain stomach/intestinal problems (e.g., gastroenteritis). Treating vomiting quickly can prevent a serious loss of body water (dehydration). Trimethobenzamide belongs to a class of drugs known as antiemetics. It works by decreasing the signals in the brain that lead to vomiting.
Take this medication by mouth, usually 3-4 times daily as needed or as directed by your doctor.
Dosage is based on your medical condition, age, and response to therapy. Take this medication exactly as directed to get the most benefit from it. Do not take more medication or take it more often than prescribed. Ask your doctor or pharmacist if you have questions.
Inform your doctor if your condition persists or worsens.
Diarrhea, headache, dizziness, drowsiness, blurred vision, or muscle cramps may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, muscle spasms, unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs), shaking (tremor), restlessness, drooling.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe arching of the back, mouth sores, unusual bleeding/bruising, seizures, mental/mood changes (e.g., depression), yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking trimethobenzamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high fever, kidney problems, stomach/intestinal problems (e.g., appendicitis), swelling/disease of the brain (encephalitis/encephalopathy), a serious loss of body water (dehydration), mineral (electrolyte) imbalance.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the effects of this drug.
Children and teenagers should not use this drug if they have chickenpox, flu, or any undiagnosed illness without first consulting a doctor about Reye's syndrome.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
If vomiting occurs just after a capsule is taken, the medication may not have had a chance to be absorbed. In these cases, use of the suppositories is recommended. Discuss this with your doctor or pharmacist.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., complete blood counts, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you take this medication regularly and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
With WebMD's Medicine Cabinet, you can check interactions with drugs.Go to medicine cabinet
©2005-2015 WebMD, LLC. All rights reserved.
WebMD does not provide medical advice, diagnosis or treatment. See additional information.


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i hate to ask this but i never have heard of .ape before, did you do a google.com search to find out just what sound code it is and whether or not a linux version exists?
never having heard of .ape before this is about all i could suggest.
the hydrogen audio forum may also be a good resource to search as well.


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Novozymes to provide enzyme technology to M&G Chemicals for world's first biomass-to-glycols plant, in China
November 18, 2013 | Francinia Protti-Alvarez
Novozymes (Bagsvaerd, Denmark) and M&G Chemicals (Luxembourg) have signed a collaboration agreement to produce biomass-based plastics in China, the two companies announced today. Novozymes will supply enzyme technology to what will be the world's first biomass-to-glycols biorefinery, which will be constructed by M&G Chemicals. The biorefinery will be located near to Fuyang, Anhui Province, China, and will have capacity to process 1 million m.t./year of biomass, approximately four times the capacity of Beta Renewables' biomass-conversion...
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Welcome Aidan
Nicholas and Valerie DiLorenzo announce the birth of their son, Aidan Levi DiLorenzo, on March 1, 2013 at Women & Infants' Hospital. He weighed 6 lbs. 10 oz. and was 19 inches long at birth.
Paternal grandparents are Frank and Lynda DiLorenzo of Cumberland. Great-grandparents are Daniel and Anita Perry of Bradford, Vt.
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Hey guys,
USPS just dropped this off about an hour ago.
This is my first PRS guitar and I am blown away. Such great craftsmanship! The guitar plays and sounds amazing.
The previous owner, my friend Ron, put custom wound Luther Lee pickups in it and switched out the gold hardware for chrome. It came with all the paperwork, the trem, case, AND a tremelno.
I have an SE 7 coming in this week too.
My only camera is my iPhone, so I'll post his pics before I get my hands on my girlfriend's DSLR :


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- SPREAD cream cheese onto bottom of microwaveable 9-inch pie plate. Mix chicken and sauce; spoon over cream cheese. Top with blue cheese and onions.
- MICROWAVE on HIGH 2 min. or until heated through.
- SERVE warm with celery sticks and WHEAT THINS Original Snacks.
Kraft Kitchens tips:
Prepare using 1 pkg. (6 oz.) OSCAR MAYER Deli Fresh Grilled Chicken Breast Strips, chopped.
Prepare using PHILADELPHIA Neufchatel Cheese.
More From Kitchen Daily:
Nutrition Facts
Provided by: Philadelphia Cream Cheese
Per Single Serving / Serves 18 Total
- Calories 70
- Total Fat 6 g
- Saturated Fat 3 g
- Sodium 150 mg
- Total Carbohydrates 1 g
- Protein 4 g
- Cholesterol 25 mg
- Sugars 1 g
- Vitamin C 2%
Percent Daily Values are based on a 2000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.


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Seeing the Beeb has us do a Pastafarian initiation ceremony yesterday for the cameras, and there was much discussion about:
a) what we should do, and
b) what it all meant,
perhaps some consensus should be reached about what we do and why (seeing we were making it up as we went along really).
My thoughts (based on what we did yesterday and some of my own drunken ramblings):
- Joinee should be asked whether s/he accepts the FSM as his/her noodly master, whether s/he has been touched by His Noodly Appendage. Makes sense doing this seeing this is a joining ceremony.
- Plate/ bowl of pasta could then be brought out. We were all sitting round a table with Robin (TV presenter/ "joinee") at the head of it in the captain's chair. We passed the plate down the table then placed it in front of him. Could make it a sort of community thing?
- Definately should involve lobbing pasta at the ceiling (because it's fun doing it). Could symbolically mean making an offering of pasta to our noodly master in heaven? Wenchless John improvised a different (and rather funny) reason, about some historical basis, and something about finding your own meaning in the random pasta shapes (I'm remembering this right aren't I John?).
- Joinee then has to slurp/ suck strand of pasta up (also funny, especially if you get some pasta whiplash thing going) - a kind of communion type thingie?
Not sure about:
- Pirate hats on or pirate hats off - if they're off they can be waved instead
- Cutlasses, daggers etc - should they be laid on the table (should we even have a table?)
- Grog - my thinking is that there should be lots of it (but then I think there should be lots of grog all the time so...)
- What happens if you're not on a BBC-hired replica pirate ship at the time? Let's face it, how often is that ever going to happen?
- Pasta - with or without sauce (can be v. messy if with sauce). Spaghetti, oriental noodles or some other type (or doesn't it matter)? Think it definately should be cooked either way.
- We did it mostly in reverent silence, but this was only really because the sound guy had problems recording anything when we were banging the table and shouting "yar" all the time. So, reverential silence, or loud and raucous?
These are only my particular musings so can be freely ignored when saner/ sensible/ more sober minds come up with stuff.
What does everyone else think?


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How to Take Things Off our Plates During Holidays Months
November is the month of thankfulness, lots of entertaining, cooking, and … piling too much on our plates.
I'm raising my hand in the air! Me, Me!
I think learning about balance during the holiday season is so important, and something that took me years to learn.
This would be a good week to sit down with a journal and write out your goals for the next 2 months.
What are the essentials? The things you really have to do, that you can't get out of.
What are the non-essentials this time of year? For me, they are parties and activities that I really don't have to attend or be a part of.
How to avoid being over-commited
1. Keep a journal of your hopes, dreams, and desires for you and your family for the holidays.
2. Separate out the pages according to Family, Must-Dos, Dreams, Invitations.
3. Prioritize the essentials and non-essentials in to each category.
4. Family: be willing to ask your family their opinion regarding whether they want to keep traditions going, or it's time to make a change.
5. Must-Dos: consider stopping, or changing the way, you've always done things in the past. Is there a better way? What would happen if you "stopped?"
6. Dream: it's beautiful to dream and come up with new ideas. Write these down and try something new!
7. Invitations: don't say yes to any invitation until you've really counted the cost.
Everyone has their own convictions regarding what is important to them. But it's true, sometimes we do over-commit.
We all know what is essential, and learning to take off our list the events that really "don't need to happen" is key!
The key to being sane.
And happy.
By the end of the day we need to learn to be at peace with how we have used our time.
Do you struggle with piling too much on your plate during November and December?
13 Responses to "How to Take Things Off our Plates During Holidays Months"
Love this – especially the one about recreating traditions. The older generation is getting less and less excited about the holidays each year which is a fun time for the younger crowd to change things up. :)
I agree with Liz – I want the holidays to be something that my children just cannot wait to participate in, and that means I have to lead by example and make sure that we can enjoy ourselves. We have such a huge tendency to over-commit as a family, and I think this year (more than ever) we need to step back and consider what we really want to make the holidays about!
This post could not have come at a more perfect time for me, Sandy! I love it! I do struggle with too much on my plate in November and December, but this year I am going to try calm it down a notch!
Oh yes, a constant struggle. Thanks so much for the encouragement and reminder Sandy!
I struggle with this all the time so I'm so happy to read these suggestions. I'm going to really take them to heart, especially that last one about not saying yes until I've counted the cost.
I needed this more than ever today! I have already started piling on for the holiday season and definitely need to take it a bit more slowly. Great post, my friend!
Yes I do struggle with this! Thank you for setting me straight and reminding me that I can say no and need to say no. And it's okay to say no. xoxo
Christmas seems to be the one time of year I over commit myself. I blame it on living so far away from our families {12+ hours to each family…who don't live near each other}. We stay in Atlanta, and I am always so determined to keep it fun even though it is just the four of us that I commit us to every holiday activity in the city it seems.
This year I am picking just 3. We need to take a step back. Christmas is my husband's busiest time of year {he manages the photo portion of Santa's Wonderland for all 57 Bass Pro Shop stores}. This year I am determined to relax and let my kids have fun just coloring pictures, baking cookies, and staying up a little too late.
Sandy, this is so timely! I need to watch as we approach the holidays–I tend to over commit and get very overwhelmed. Loved the part about writing down your dreams too!
Love this post – it's so important to know what you want to get out of the season. We really can't do it all. And, if we try, we will be so stressed and overwhelmed that we won't be able to enjoy the things that matter the most to us.
We have a list that hangs on the inside of our front door. It's a running list of things we want to do, e.g. museums, new restaurants to try, new recipes to try (the teenager likes to cook), etc.
I think perhaps we should make a Holiday List to help us keep focused on the things that we value most.
~ Dana
Cooking at Cafe D
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Pingback: Making Corn Relish for Holiday Gifts | reluctantentertainer.com Reluctant Entertainer I Sandy Coughlin - Lifestyle, Entertaining, Food, Recipes, Hospitality and Gardening
Pingback: Links Worth Sharing - Week of November 10, 2012 - Simply Frugal