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[[Category:PEACE Global Community| ]]
[[Category:PEACE Global Community| ]]
Revision as of 00:43, 31 May 2012
This article is part of the series:
The PEACE Global Community (formally People of Earth Associated under Common Excellence: Global Community, known colloquially as PEACE or the PEACE GC) was a worldwide military alliance that in its original incarnation consisted of all former FIST member nations as well as many former Mediterranean Alliance and PANAM members. PEACE was the largest alliance in eRepublik history, growing from its original 15 member countries to a peak of 30. After a schism in November 2009, much of PEACE's military strength and nearly all of its most prominent members left the alliance to later create a new alliance, PHOENIX.
- 1 History
- 2 Dissolution of PEACE
- 3 Membership
- 4 Global Security Council
- 5 Charter
- 6 PEACEKeepers
- 7 Relations with ATLANTIS and EDEN
- 8 References
- 9 External links
PEACE was largely a consolidation of FIST and pro-FIST former- Mediterranean Alliance nations. The Mediterranean Alliance had been declining for several months with a rift growing between Spain and most other Mediterranean countries as they took sides between the Northern Alliance and FIST. By July, the Mediterranean Alliance had effectively ceased to exist and the pro-FIST countries strengthened their ties with the FIST powers but didn't go so far as to join the alliance for fear of stalemating the game.
In mid-August, talks between the leaders of FIST and these Mediterranean nations began to form their own alliance to counteract ATLANTIS. The alliance became a reality only after the publication of the Atlantis Treaty. The original Atlantis plan was to create an alliance where small countries could be protected from imperialistic nations. But this did not happen. Atlantis became an alliance between the largest nations of the world. This created unrest between the nations of the new world and within the member nations of the Atlantis Alliance. But only Brazil refused to sign the treaty, as it violated the Brazilians ideals about peaceful existence within the new world. This leads Brazil to contact FIST representative Alan Gordon that immediately contacts all friendly nations. After 36 hours of intensive and continuous debate the Charter was created and posted on August 27, 2008, Day 281 of the New World and signed by member nations over the following few days.
Two military conflicts tested the new alliance within days of its formation. On August 27, presumed PEACE protectorate Mexico attacked Spain as part of a failed Spanish political takeover that had been ongoing throughout the month of August. PEACE rushed to the aid of the local population and due to the quick thinking of PEACE strategists that instructed PEACE forces to use Portugal to isolate the Spanish and Mexican Territories, the conflict was adverted. On August 29, Romania, seeking to expand its borders, invaded Hungary before their MPPs with any PEACE nations could be finalized. PEACEKeepers, many of them fresh out of the Mexican conflict, were rushed to the defense of Hungary.
In September 2008, following lengthy discussion in the Security Council, Mexico was admitted to the Global Community as a full member nation.
In 23th April 2009, 2 new countries were admitted to the Global Community as a full member nation: Thailand, Serbia.
Later in the 7th day of July 2009, Philippines became an official member of to the global Community.
On November 11th 2009, Italy became the first Member Nation of PEACE to leave the Alliance. One Major Reason for this was due to them being PTO'd by Croatia, and instead of PEACE sending Mobile Voters to fend off the PTO, they chose (Although They Failed) to PTO Canada. There are other smaller reasons for the split, but all that matters is that the Italians have withdrawn their Membership.
On November 13th 2009, Indonesia left PEACE GC upon declaring war on Malaysia followed by the conquest of Southern Thailand. Other PEACE members did not support Indonesia's war declaration on Malaysia because Malaysia is a neutral nation, which resulted in Indonesia's decision to leave PEACE GC.
On November 16th 2009, Hungary left PEACE GC.
On November 17th 2009, Russia, Iran, Latvia, Turkey and Serbia left PEACE GC.
On November 18th, 2009, Argentina and France, two of the remaining active members of PEACE GC, declared an amendment to the PEACE charter in light of the political situation. With the departure of major military contributing PEACE members, a de facto dissolution of the alliance is under way and accelerated with Hungary's invasion of Burgenland, Austria.
On November 19th 2009, Estonia left PEACE GC.
On November 20th 2009, Chile, Portugal and Slovenia left PEACE GC.
On November 21st 2009, Germany and United Kingdom left PEACE GC.
On November 22nd 2009, Lithuania left PEACE GC.
On November 23rd 2009, Brazil and the United Netherlands left PEACE GC.
On November 24th 2009, Colombia and Paraguay left PEACE GC.
On January 2nd 2010, France left PEACE GC.
Dissolution of PEACE
Because of the rate that major countries were leaving PEACE, one of the alliance's official newspapers declared the alliance disbanded on November 19th, 2009 on the grounds that PEACE had became complacent, lost sight of what was important to it and let its organisation falter as a result.[1] The disbandment was later denied by official French sources[2] [3], which also said that a new charter was in the works.[4]
February 2009
Greece left the Global Community on 19 February 2009 when ATLANTIS troops assisted Greek partisans in freeing Greece from Turkish dominance.
November Cascade
Italy withdrew on 11 November 2009.[5] Two days later, on 13 November, Indonesia withdrew from PEACE.[6] Three days after Indonesia's departure, Hungary followed suit and left the alliance on 16 November.[7] The next day, Iran, Latvia, Russia, Serbia, and Turkey announced their withdrawals from PEACE.[8][9][10][11][12] Estonia left two days later on 19 November.[13] On 20 November, Chile, Portugal, and Slovenia left the alliance.[14][15][16] Germany and the United Kingdom left the alliance on 21 November.[17][18] Lithuania left the alliance on 22 November[19] Brazil and the United Netherlands withdrew on 23 November.[20][21] Colombia and Paraguay left the alliance on 24 November after their congresses decided not to sign the revised charter
France, one of the few remaining nations most interested in the continued existence of PEACE, formed the Entente with Italy and Ukraine on December 15, 2009, effectively ending the PEACE Global Community.
Global Security Council
The Global Security Council was the administrative body of the Global Community, consisting of a single Representative and two Advisory Representatives from each member nation. Each nation's Representative was usually its President, but Presidents may have choose an Acting Representative to serve as a Representative for any reason. Additionally, each member nation may have also appointed two people to serve as Advisory Representatives, who were privy to all discussions held in the Security Council but not able to vote on issues.
The Security Council and, through the Council, the alliance as a whole, was led by an elected Secretary-General or Secretaries-General. The Secretary-General served as a spokesperson for the alliance and was the ultimate commander of the PEACEKeepers, the alliance's military force.
|28 Aug. '08 – 14 Oct. '08
|Nicolae Carpathia
|15 Oct. '08 – 1 Jan. '09
|Matthieu Bonne
|2 Jan. '09 – 31 Jan. '09
|1 Feb. '09 – 4 Feb. '09
|Matthieu Bonne (Interim)
|5 Feb. '09 – 20 Feb. '09
|21 Feb. '09 – 9 Mar. '09
|Arthk (Interim)
|10 Mar. '09 – 9 Jun. '09
|10 Jun. '09 – 18 Jul. '09
|19 Jul. '09 – 24 Aug. 09
|Matthieu Bonne
|25 Aug. 09 - 6. Sept. 09
|7. Sept. 09 - 19. Nov. 09
|Arthk (Interim)
Other people involved in PEACE administration included:
|Vice Secretary-General
|Supreme Commander
|Feherlofia Koppany
|War Games Organizer
|Kurzemes Karalis Kristaps
|Media Mogul Medal Program Organizer
The PEACE GC charter is currently going through a revision. The current proposal being discussed can be reached here.
|" The Security Council shall have the power to raise an Army of the PEACE Global Community consisting of soldiers from each Member's military. "
(Charter of the PEACE Global Community, Clause 7.1)
The Global Community PEACEKeeping Force (also known as the PEACEKeepers) was the official army of the Global Community.
Relations with ATLANTIS and EDEN
Relations between the Global Community and its rival alliance, ATLANTIS, had been strained since the inception of the Global Community. PEACEKeepers fought against Spanish soldiers in Mexico during the Ibero-American war to prevent Spain from advancing into Mexican territory. Two days after the Charter was signed by all member nations, Romania moved to declare war on Hungary in what would become World War I.
After an armistice was called in World War I, relations between the two alliances normalized somewhat. The Global Community opened the Department of Diplomatic Affairs and invited ATLANTIS officials, including American diplomats ThisGenMedia and Emerick, Argentinian kurtkbain, and Spanish diplomat Meiko, to visit and negotiate with the PEACE Security Council.
EDEN were also opposed to PEACE due to their popularly-accepted position as ATLANTIS' successor.
War of Spanish Aggression
On August 27, soldiers of the fledgling alliance travelled to Mexico to protect the country from a Spanish political coup. While Spain had their hands full with PEACEKeeping Forces and the local Mexican population, Portugal swooped in and solidified Portuguese control of the Mexican beachhead, blocking Mexican and Spanish access alike to the country. Portugal quickly made peace with Mexico, preventing the Spanish from organizing from within Mexico to attack Portugal.
World War I
Romania attacked Hungary on August 29, at a time when they felt would be the best at any point in the near future, as Hungary didn't yet have MPPs set up with many PEACE powers and those it did have MPPs with they believed to be tired from the war in Mexico. Despite this, hundreds of PEACEkeepers, many of them fresh out of Mexico, came to the aid of Hungary and overwhelmingly crushed the initial offensive. The war was eventually halted after Romania made inroads into Hungary due to overwhelming problems caused by bugs. biased
Attempted Romanian coup in Bulgaria
In September 2008, PEACE member nation Bulgaria was tipped off to a number of Romanians, including former President of Ireland Victor Petrescu, who had moved to cities around Bulgaria. In response, Bulgarian President krembo called upon the Security Council for help. Secretary-General Carpathia ordered PEACEKeepers to move to Bulgaria to counter the Romanian influx. Romanian President Alex Craciun, in a communiqué sent to krembo, said that the Romanian presence was to thwart a perceived goon presence, despite the fact that krembo had asked for goon assistance in preventing the Romanian takeover.
- ↑ http://www.erepublik.com/en/article/the-end-of-an-era1-1039974/1/20 The end of an era
- ↑ http://www.erepublik.com/en/article/-en-fr-peacegc-isn-t-dissolved-eaustria-vs-ehungary-1040092/1/20 Peace isn't dissolved
- ↑ http://www.erepublik.com/en/article/la-france-dans-l-emonde-informations-et-id-es-re-ues-1041007/1/20 La France dans l'eMonde: informations et idées reçues
- ↑ http://wiki.erepublik.com/index.php/User:VSkyzv/Library/Revised_Charter_of_PEACE_GC Revised Charter of PEACE GC
- ↑ http://www.erepublik.com/en/article/adieu-peace-goodbye-peace-adios-peace-addio-peace-auf-wiedersehen-peace-1028412/1/20 Adieu PEACE/Goodbye PEACE/Adios PEACE/Addio PEACE/Auf Wiedersehen PEACE
- ↑ http://www.erepublik.com/en/article/-with-pride-honor-and-tears-indonesia-to-say-goodbye-from-peacegc--1030808/1/20 [WITH PRIDE, HONOR, AND TEARS] INDONESIA TO SAY GOODBYE FROM PEACEgc!
- ↑ http://www.erepublik.com/en/article/-emagyar-k-zl-ny-emagyarorsz-g-hivatalos-k-zlem-nye-a-peace-b-l-val-kil-p-sr-l-1037044/1/20 eMagyarország hivatalos közleménye a PEACE-ből való kilépésről / eHungary quits PEACE GC
- ↑ http://www.erepublik.com/en/article/-erussia-and-peace-ru-en-1037607/1/20 еРоссия и ПИС, eRussia and PEACE RU/EN
- ↑ http://www.erepublik.com/en/article/-eiran-s-gov-goodbye-peace-1037647/1/20 Goodbye PEACE
- ↑ http://www.erepublik.com/en/article/esrbija-napusta-peace-eserbia-leaves-peace--1037937/1/20 eSrbija napusta PEACE!/eSerbia leaves PEACE!
- ↑ http://www.erepublik.com/en/article/peace-e-elveda-farewell-to-peace-1038294/1/20 Peace'e Elveda / Farewell to PEACE
- ↑ http://www.erepublik.com/en/article/latvija-izst-jas-no-peace-latvia-withdraws-from-peace-1038344/1/20 Latvija izstājas no PEACE / Latvia withdraws from PEACE
- ↑ http://www.erepublik.com/en/article/eesti-astub-peace-gc-st-v-lja-estonia-resign-from-peace-gc-1041665/1/20 Eesti astub PEACE GC-st välja / Estonia resign from PEACE GC
- ↑ http://www.erepublik.com/en/article/chile-y-peace-gc-1043506/1/20 Chile y PEACE GC
- ↑ http://www.erepublik.com/en/article/eportugal-leaves-peace-gc-1043508/1/20 ePortugal leaves PEACE-GC
- ↑ http://www.erepublik.com/en/article/slovenia-zapu-a-peace-gc-1043578/1/20 Slovenia zapušča PEACE GC
- ↑ http://www.erepublik.com/en/article/peace-gc-the-future-and-egermany-1045284/1/20
- ↑ http://www.erepublik.com/en/article/-pm-dust-in-the-wind-euk-votes-to-leave--1045207/1/20
- ↑ http://www.erepublik.com/en/article/-im-lietuva-palieka-peace-gc-lithuania-leaves-peace-gc-1045689/1/all
- ↑ http://www.erepublik.com/en/article/at-mais-peace-farewell-peace-1048413/1/20 Até mais PEACE | Farewell PEACE
- ↑ http://www.erepublik.com/en/article/-unl-the-united-netherlands-leaves-peace-gc-1048383/1/20#comments
External links
Announcements from the Secretary-General
- 26 August - Statement Regarding the Mexican Situation by the PEACE Global Security Council
- 27 August - PEACE Global Security Council Issues Statement to Government of Spain
- 28 August - PEACE Global Community Secretary-General Nicolae Carpathia condemns President and Congress of Romania
- 30 August - PEACEKeepers and Hungarian citizens disappear in middle of Romanian attack
- 12 September - Secy-Gen Nicolae Carpathia comments on United States situation
- 26 September - Disclosure of PEACEKeeping Operations
- 28 September - Ascension of the United Mexican States to the PEACE Global Community
|Game alliances
|Asteria (2014–) · CODE (2019–) · Pacifica (2014–)
|Andes (2017–) · Hydra (2019–) · Orion (2015–)
|2009–2010 dissolutions
|ATLANTIS (2008–2009) · PEACE (2008–2009) · ALA (2009–2010) · Sol (2009–2010) · Fortis (2009) · Brolliance (2009–2010) · Entente (2010) · ONE (2009–2010)
|2011–2013 dissolutions
|Phoenix (2009–2011) · PACMAN (2010–2011) · Luna (2011) · Arab Confederation (2011–?) · EPIC (2012) · NWO/ONE (2011–2012) · PANAM/Terra (2010–2012) · CTRL (2012) · ABC (2011–2012) · GEA (2011–2012) · EDEN (2009–2013) · CoT (2012–2013) · WOLF (2013) · NaN (2013)
|2014–2019 dissolutions
|TWO (2012–2014) · Sirius (2014) · Aurora (2014) · Leto (2014–2015) · Asgard (2012–2015) · Root (2014–2015) · P.L.U.T.O. (2015–2016) · Syndicate (2016–2017) · Adriatica (2016–2017) · Nebula (2015–2019)


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Greinke's bid for 100th win spoiled by Latos, Reds' bats
LOS ANGELES -- Zack Greinke and the Dodgers saw several streaks come to an end on Thursday.
Greinke lost for the first time in his past seven starts as the Dodgers fell to the Reds, 5-2, at a sold out Dodger Stadium to snap a six-game winning streak coming out of the All-Star break.View Full Game Coverage
LOS ANGELES -- Zack Greinke and the Dodgers saw several streaks come to an end on Thursday.
Greinke lost for the first time in his past seven starts as the Dodgers fell to the Reds, 5-2, at a sold out Dodger Stadium to snap a six-game winning streak coming out of the All-Star break.View Full Game Coverage
It was Greinke's first loss since June 16, and his first career defeat in seven starts against the Reds. The right-hander allowed four runs on six hits in seven innings, striking out four against one walk to come up short in his bid for his 100th career win.
"I made a lot of good pitches, but I made a couple of bad pitches and they capitalized on it," said Greinke, who gave up two home runs and lost at Dodger Stadium for the first time as a member of the home team. "The damage they did was big damage, it wasn't just a single."
Greinke gave up two runs over the first two innings, which was more than he'd allowed in his past three starts combined. Former Dodgers outfielder Xavier Paul homered to right in the first, while Todd Frazier doubled and scored on a bloop single by Cesar Izturis in the second.
But Greinke settled in and retired 10 of the next 11 batters before things went south in a hurry in the sixth. With the bases empty and two outs, Greinke hit Brandon Phillips with an 0-2 pitch. The next batter, Jay Bruce, launched a hanging curveball into the bleachers in left-center field for a two-run homer and a 4-1 Reds lead.
"I've got him out on curves a lot in the past, but he hit that one good," Greinke said. "It wasn't a good pitch. It's worked in the past, but it didn't work today. It was probably a mistake on my part. I thought the pitch was going to work no matter how I threw it."
Bruce was 2-for-21 lifetime against Greinke before the home run.
"He didn't make very many mistakes, but the ones he did make, we took advantage of," Bruce said. "That's what you have to do against a pitcher of that caliber."
While the Dodgers twice overcame deficits during a three-game sweep of the Blue Jays earlier this week, they couldn't do the same against Reds starter Mat Latos and scored fewer than eight runs for the first time in five games.
Perhaps the low output was a result of their cross-country flight after an extra-innings victory in Toronto on Wednesday night. But Dodgers manager Don Mattingly didn't offer any excuses and instead praised Latos, who allowed two runs in 7 2/3 innings to pick up his 10th win of the season.
"I thought our guys had very good energy today, you have to give their guy credit," Mattingly said. "Latos is a guy who has given us trouble in the past. He's got quality stuff. To me, every time you face him you've got your hands full."
While sometimes a detriment, Yasiel Puig's aggressiveness paid dividends in the fourth. The rookie led off with a single to center and took a wide turn at first base, which coaxed a wild throw from center fielder Shin-Soo Choo that bounced into the photo well. Puig was awarded third base and scored on a groundout by Adrian Gonzalez.
Carl Crawford led off the eighth with a double, moved to third on a groundout by Puig and scored on another groundout by Gonzalez, who leads the Dodgers with 64 RBIs and is hitting .318 with 16 RBIs in 20 games this month.
Puig had two of the Dodgers' eight hits. It was the third consecutive multihit game for the outfielder, and the 21st of his young career (45 games).
One year removed from coming to the Dodgers in a trade with the Marlins, Hanley Ramirez had two hits and a stolen base. The shortstop has reached base in 33 straight games, the second-longest active streak behind Reds first baseman Joey Votto, who singled twice to extend his streak to 37 games.
J.P. Howell relieved Greinke and tossed a scoreless eighth. The left-hander hasn't allowed a run in 13 of his past 14 appearances.
Pitching at home for the first time since coming to the Dodgers in a trade with the Cubs, Carlos Marmol allowed one run on two hits and a walk in the ninth. In two appearances with the Dodgers, Marmol has given up four earned runs over 2 2/3 innings with two walks. The right-hander has a 6.53 ERA in 33 appearances combined with the Cubs and Dodgers.
"I think his stuff is still good," Mattingly said. "He's getting better. We're just going to see what we get."
Austin Laymance is an associate reporter for MLB.com.

subset: commoncrawl


text:
Methods and apparatus for dynamically stable spinal implant
Apparatus and methods are directed at stabilizing somatic implants. A site within a body is selected that has a first region having a tight and/or changing curvature bordered by a second region or regions having minimal or constant curvature. An apparatus that has a flexible portion and one or more relatively rigid portions may then be implanted such that the flexible portion is situated in the first region and the rigid portion lies in the second region whereby the implant will remain dynamically stable and resist migration.
Latest Intrinsic Therapeutics, Inc. Patents:
This application is a continuation of U.S. application Ser. No. 09/696,636 filed on Oct. 25, 2000 now 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 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 U.S. Pat. No. 6,425,919, and claims benefit to U.S. Provisional Application No. 60/149,490 filed Aug. 18, 1999, U.S. Provisional Application No. 60/161,085 filed Oct. 25, 1999 and U.S. Provisional Application No. 60/172,996 filed Dec. 21, 1999 the contents of each of which are incorporated in their entirety into this disclosure by reference.BACKGROUND 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 annulus fibrosis, herniation of the nucleus pulposus and/or significant disc height loss.
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 annulus 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.
Since its original description by Mixter & Barr in 1934, discectomy has been the most common surgical procedure for treating intervertebral disc herniation. This procedure involves removal of disc materials impinging on the nerve roots or spinal cord external to the disc, generally posteriorly. Depending on the surgeon's preference, varying amounts of NP are then removed from within the disc space either through the herniation site or through an incision in the AF. This removal of extra NP is commonly done to minimize the risk of recurrent herniation.
Nevertheless, the most significant drawbacks of discectomy are recurrence of herniation, recurrence of radicular symptoms, and increasing low back pain. Re-herniation can occur in up to 21% of cases. The site for re-herniation is most commonly the same level and side as the previous herniation and can occur through the same weakened site in the AF. Persistence or recurrence of radicular symptoms happens in many patients and when not related to re-herniation, tends to be linked to stenosis of the neural foramina caused by a loss in height of the operated disc. Debilitating low back pain occurs in roughly 14% of patients. All of these failings are most directly related to the loss of NP material and AF competence that results from herniation and surgery.
Loss of NP material deflates the disc, causing a decrease in disc height. Significant decreases in disc height have been noted in up to 98% of operated patients. Loss of disc height increases loading on the facet joints. This can result in deterioration of facet cartilage and ultimately osteoarthritis and pain in this joint. As the joint space decreases the neural foramina formed by the inferior and superior vertebral pedicles also close down. This leads to foraminal stenosis, pinching of the traversing nerve root, and recurring radicular pain. Loss of NP also increases loading on the remaining AF, a partially innervated structure that can produce pain. Finally, loss of NP results in greater bulging of the AF under load. This can result in renewed impingement by the AF on nerve structures posterior to the disc.
Persisting tears in the AF that result either from herniation or surgical incision also contribute to poor results from discectomy. The AF has limited healing capacity with the greatest healing occurring in its outer borders. Healing takes the form of a thin fibrous film that does not approach the strength of the uninjured disc. Surgical incision in the AF has been shown to produce immediate and long lasting decreases in stiffness of the AF particularly against torsional loads. This may over-stress the facets and contribute to their deterioration. Further, in as many as 30% of cases, the AF never closes. In these cases, not only is re-herniation a risk but also leakage of fluids or solids from within the NP into the epidural space can occur. This has been shown to cause localized pain, irritation of spinal nerve roots, decreases in nerve conduction velocity, and may contribute to the formation of post-surgical scar tissue in the epidural space.
Other orthopedic procedures involving removal of soft tissue from a joint to relieve pain have resulted in significant, long lasting consequences. Removal of all or part of the menisci of the knee is one example. Partial and total meniscectomy leads to increased osteoarthritic degeneration in the knee and the need for further surgery in many patients. A major effort among surgeons to repair rather than resect torn menisci has resulted in more durable results and lessened joint deterioration.
Systems and methods for repairing tears in soft tissues are known in the art. One such system relates to the repair of the menisci of the knee and is limited to a barbed tissue anchor, an attached length of suture, and a suture-retaining member, which can be affixed to the suture and used to draw the sides of a tear into apposition. The drawback of this method is that it is limited to the repair of a tear in soft tissue. In the intervertebral disc, closure of a tear in the AF does not necessarily prevent further bulging of that disc segment toward the posterior neural elements. Further, there is often no apparent tear in the AF when herniation occurs. Herniation can be a result of a general weakening in the structure of the AF (soft disc) that allows it to bulge posteriorly without a rupture. When tears do occur, they are often radial.
Another device known in the art is intended for repair of a tear in a previously contiguous soft tissue. Dart anchors are placed across the tear in a direction generally perpendicular to the plane of the tear. Sutures leading from each of at least two anchors are then tied together such that the opposing sides of the tear are brought together. However, all of the limitations pertaining to repair of intervertebral discs, as described above, pertain to this device.
Also known in the art is an apparatus and method of using tension to induce growth of soft tissue. The known embodiments and methods are limited in their application to hernias of the intervertebral disc in that they require a spring to apply tension. Aside from the difficulty of placing a spring within the limited space of the intervertebral disc, a spring will induce a continuous displacement of the attached tissues that could be deleterious to the structure and function of the disc. A spring may further allow a posterior bulge in the disc to progress should forces within the disc exceed the tension force applied by the spring. Further, the known apparatus is designed to be removed once the desired tissue growth has been achieved. This has the drawback of requiring a second procedure.
There are numerous ways of augmenting the intervertebral disc disclosed in the art. In reviewing the art, two general approaches are apparent—implants that are fixed to surrounding tissues and those that are not fixed, relying instead on the AF to keep them in place.
The first type of augmenting of the intervertebral disc includes generally replacing the entire disc. This augmentation is limited in many ways. First, by replacing the entire disc, they generally must endure all of the loads that are transferred through that disc space. Many degenerated discs are subject to pathologic loads that exceed those in normal discs. Hence, the designs must be extremely robust and yet flexible. None of these augmentation devices has yet been able to achieve both qualities. Further, devices that replace the entire disc must be implanted using relatively invasive procedures, normally from an anterior approach. They may also require the removal of considerable amounts of healthy disc material including the anterior AF. Further, the disclosed devices must account for the contour of the neighboring vertebral bodies to which they are attached. Because each patient and each vertebra is different, these types of implants must be available in many shapes and sizes.
The second type of augmentation involves an implant that is not directly fixed to surrounding tissues. These augmentation devices rely on an AF that is generally intact to hold them in place. The known implants are generally inserted through a hole in the AF and either expand, are inflated, or deploy expanding elements so as to be larger than the hole through which they are inserted. The limitation of these concepts is that the AF is often not intact in cases requiring augmentation of the disc. There are either rents in the AF or structural weaknesses that allow herniation or migration of the disclosed implants. In the case of a disc herniation, there are definite weaknesses in the AF that allowed the herniation to occur. Augmenting the NP with any of the known augmentation devices without supporting the AF or implant risks re-herniation of the augmenting materials. Further, those devices with deployable elements risk injuring the vertebral endplates or the AF. This may help to retain the implant in place, but again herniations do not require a rent in the AF. Structural weakness in or delamination of the multiple layers of the AF can allow these implants to bulge toward the posterior neural elements. Additionally, as the disc continues to degenerate, rents in the posterior annulus may occur in regions other than the original operated site. A further limitation of these concepts is that they require the removal of much or all of the NP to allow insertion of the implant. This requires time and skill to achieve and permanently alters the physiology of the disc.
Implanting prostheses in specific locations within the intervertebral disc is also a challenging task. The interior of the disc is not visible to the surgeon during standard posterior spinal procedures. Very little of the exterior of the disc can be seen through the small window created by the surgeon in the posterior elements of the vertebrae to gain access to the disc. The surgeon further tries to minimize the size of any annular fenestration into the disc in order to reduce the risk of postoperative herniation and/or further destabilization of the operated level. Surgeons generally open only one side of the posterior annulus in order to avoid scarring on both sides of the epidural space.
The rigorous requirements presented by these limitations on access to and visualization of the disc are not well compensated for by any of the intradiscal prosthesis implantation systems currently available.
The known art relating to the closure of body defects such as hernias through the abdominal wall involve devices such as planer patches applied to the interior of the abdominal wall or plugs that are placed directly into the defect. The known planar patches are limited in their application in the intervertebral disc by the disc's geometry. The interior aspect of the AF is curved in multiple planes, making a flat patch incongruous to the surface against which it must seal. Finally, the prior art discloses patches that are placed into a cavity that is either distended by gas or supported such that the interior wall of the defect is held away from internal organs. In the disc, it is difficult to create such a cavity between the inner wall of the annulus and the NP without removing nucleus material. Such removal may be detrimental to the clinical outcome of disc repair.
One hernia repair device known in the art is an exemplary plug. This plug may be adequate for treating inguinal hernias, due to the low pressure difference across such a defect. However, placing a plug into the AF that must resist much higher pressures may result in expulsion of the plug or dissection of the inner layers of the annulus by the NP. Either complication would lead to extraordinary pain or loss of function for the patient. Further, a hernia in the intervertebral disc is likely to spread as the AF progressively weakens. In such an instance, the plug may be expelled into the epidural space.
Another hernia repair device involves a curved prosthetic mesh for use in inguinal hernias. The device includes a sheet of material that has a convex side and a concave side and further embodiments with both spherical and conical sections. This device may be well suited for inguinal hernias, but the shape and stiffness of the disclosed embodiments are less than optimal for application in hernias of the intervertebral disc. Hernias tend to be broader (around the circumference of the disc) than they are high (the distance between the opposing vertebrae), a shape that does not lend itself to closure by such conical or spherical patches.
Another device involves an inflatable, barbed balloon patch used for closing inguinal hernias. This balloon is left inflated within the defect. A disadvantage of this device is that the balloon must remain inflated for the remainder of the patient's life to insure closure of the defect. Implanted, inflated devices rarely endure long periods without leaks, particularly when subjected to high loads. This is true of penile prostheses, breast implants, and artificial sphincters.
Another known method of closing inguinal hernias involves applying both heat and pressure to a planar patch and the abdominal wall surrounding the hernia. This method has the drawback of relying entirely on the integrity of the wall surrounding the defect to hold the patch in place. The annulus is often weak in areas around a defect and may not serve as a suitable anchoring site. Further, the planar nature of the patch has all of the weaknesses discussed above.
Various devices and techniques have further been disclosed for sealing vascular puncture sites. The most relevant is a hemostatic puncture-sealing device that generally consists of an anchor, a filament and a sealing plug. The anchor is advanced into a vessel through a defect and deployed such that it resists passage back through the defect. A filament leading from the anchor and through the defect can be used to secure the anchor or aid in advancing a plug that is brought against the exterior of the defect. Such a filament, if it were to extend to the exterior of the disc, could lead to irritation of nerve roots and the formation of scar tissue in the epidural space. This is also true of any plug material that may be left either within the defect or extending to the exterior of the disc. Additionally, such devices and methods embodied for use in the vascular system require a space relatively empty of solids for the deployment of the interior anchor. This works well on the interior of a vessel, however, in the presence of the more substantial NP, the disclosed internal anchors are unlikely to orient across the defect as disclosed in their inventions.SUMMARY OF THE INVENTION
It is an object of the disclosed invention to reduce the long-term negative consequences of back injuries such as herniated discs by repairing and/or augmenting rather than resecting the soft tissues of the disc. It is a further object of this invention to prevent or reduce the occurrence of re-herniation and disc height loss following surgical therapy for herniated discs. It is a further object of this invention to increase the AF's resistance to posterior bulging and leakage of NP material while preferably increasing its stiffness under load. It is a further object of this invention to permit the augmentation of the soft tissues of the disc in such a way so as to limit the risk of the herniation of any augmentation materials toward nerve structures posterior to the disc. It is a further object of the present invention to shield the sensitive nerve fibers in the outer layers of the annulus from pressures within the nucleus.
In one aspect of the present invention there is provided an in vivo augmented functional spine unit. The augmented functional spine unit includes the two adjoining vertebrae and the intervertebral disc, composed of a central region surrounded by an annulus fibrosis and situated in the intervertebral disc space between the vertebra, and a disc herniation constraining device situated within the intervertebral disc space. The disc herniation constraining device includes an anchor fixedly coupled to an anterior portion of one of the adjoining vertebrae or annulus fibrosis and is connected to a support member by a connecting member. The support member is positioned posterior to the central region, preferably in or posterior to the annulus fibrosis. In one embodiment the central region of the functional spine unit contains a nucleus pulposus. In another embodiment of the invention, the connection member is maintained under tension between the anchor and the support member. In yet another embodiment, augmentation material is secured along at least a portion of the length of the connection member, which serves to assist the function of the intervertebral disc in supporting and separating the vertebrae, and allowing motion of one vertebra relative to the other.
In another aspect of the invention there is provided an in vivo augmented functional spine unit. The augmented functional spine unit includes the two adjoining vertebrae and the intervertebral disc, composed of a central region surrounded by an annulus fibrosis and situated in the intervertebral disc space between the vertebra, and a disc augmentation device situated within the intervertebral disc space. The disc augmentation device includes an anchor fixedly coupled to an anterior portion of one of the adjoining vertebrae or annulus fibrosis, augmentation material situated in the intervertebral disc space and restrained therein by a connection member secured between the anchor and the augmentation material. In an alternate embodiment, a support member is secured within the functional spine unit, the connection member extends between the anchor, the augmentation material and the support member, further restraining the movement of the augmentation material within the central region. In yet another embodiment, the central region may contain a nucleus pulposus.
In yet another aspect of the present invention there are provided methods of augmenting a functional spine unit. These methods include using the disc herniation constraining devices and the disc augmentation devices disclosed herein.
The present invention further relates to devices and methods for sealing defects in tissue walls separating two anatomic regions of the body. Specifically, prosthetic devices and methods are disclosed which allow the closure of a defect in the AF of the human intervertebral disc, preventing the egress of material from within the disc and/or distributing pressure within the disc space across an inner wall surface of the disc.
Closure of the defect is achieved by placing a membrane or barrier on an interior aspect of the defect. In the case of the intervertebral disc, the barrier is positioned either on the interior aspect of the AF proximate to the NP or between layers of the AF. The barrier means may be inserted by dissecting a space between the annulus and nucleus. Alternatively, a portion of the nucleus and/or annulus may be resected to create adequate space.
The barrier may be inserted into position directly through the defect or alternatively it may be advanced from a remote entry through the tissue wall or other tissue neighboring the defect.
Various fixation devices can be used to secure the barrier to surrounding tissues. In the intervertebral disc, these tissues can include the surrounding AF, vertebral endplates, vertebral bodies, and even NP. Alternatively, the barrier can be held in place simply by the pressure the NP exerts on the barrier and AF where the stiffness and shape of the barrier patch may also help to maintain position and orientation within the disc. The barrier may further incorporate various self-retaining members that resist motion of the barrier within the disc. The barrier or membrane may incorporate a frame that can serve to enlarge or expand the dimensions of the barrier from a compressed state to an enlarged state. The frame can be a self expanding material such as a nickel titanium material. The barrier may further have properties that cause it to adhere to surrounding tissues either with an adhesive, by the application of heat, or ingrowth/ongrowth of surrounding tissue. Various embodiments of the disclosed barrier are composed of either singular materials and components or a multiplicity of materials and components.
It is a further object of the present invention to reduce the limitations of current disc repair methods. It is a further object of the present invention to provide systems and methods for implanting a prosthesis along the interior aspect of the annulus through a single, small annulotomy from the posterior aspect of the disc.
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.
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 (annulus 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 annulus 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 annulus 10 without a true perforation has also been linked to chronic low back pain. Such a disruption 4 is illustrated in FIG. 1C. It is thought that weakness of these inner layers forces the sensitive outer annular lamellae to endure higher stresses. This increased stress stimulates the small nerve fibers penetrating the outer annulus, which results in both localized and referred pain.
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 annulus 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 1 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
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.
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 annular 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 annulus fibrosis 10. The device acts to seal the annular 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 annulus surrounding the annular 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 polymaide or polyester, a polyethplene, and can further be an expanded material, such as expanded polytetrafluroethelene (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 FIG. 15. The second barrier 24 can further be affixed to the inner barrier means 12 by the use of a fixation means 14 such as suture material.
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 annulus 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 annulus 10 until it contacts healthy tissues on all sides of the defect 16. Depending on the extent of the defect 16, the contacted tissues can include the annulus 10, cartilage overlying the vertebral endplates, and/or the endplates themselves.
In the preferred embodiment, the barrier means 12 consists of 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 0.001 inches (0.127 mm) and 0.063 inches (1.600 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 annulus 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 annulus 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 annulus 10 on either or both sides of the defect 16 as depicted in
A dissecting tool can be used to form an opening extending circumferrentially 31 within the annulus 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 or opening 16 in the annulus. This process can make use of the naturally layered structure in the annulus 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 FIG. 25. The barrier 12 can be positioned across the defect 16 as well as the entirety of the posterior aspect of the annulus fibrosis 10. Such dimensions of the barrier 12 can help to prevent the barrier 12 from slipping after insertion and can aid in distributing the pressure of the nucleus 20 evenly along the posterior aspect of the annulus 10.
The barrier 12 can be used in conjunction with an augmentation device 11 inserted within the annulus 10. The augmentation device 11 can include separate augmentation devices 42 as shown in FIG. 26. The augmentation device 11 can also be a single augmentation device 44 and can form part of the barrier 12 as barrier region 300, coiled within the annulus fibrosis 10, as shown in FIG. 27. Either the barrier 12 or barrier region 300 can be secured to the tissues surrounding the defect 16 by fixation devices or darts 25, or be left unconstrained
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
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 annulus. 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 annulus 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 annulus fibrosis.
The embodiment of the frame 153 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
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 annulus 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 annulus 20 near the implant location, as shown in FIG. 49E. Further pulling on the control filament 406 causes the proximal end 426 of the implant 400 to dissect along the inner aspect of the annulus 20 until the attachment site 414 or sites of the guide filament 406 to the implant 400 has been pulled to the inner aspect of the annulotomy 416, as shown in FIG. 49D. In this way, the implant 400 will extend at least from the annulotomy 416 and along the inner aspect of the annulus 10 in the desired implant location, illustrated in FIG. 49F.
The implant 400 can be any of the following: nucleus replacement device, nucleus augmentation device, annulus augmentation device, annulus 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 annulus fibrosis of an intervertebral disc through a defect in the disc. The material within the annulus 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 annulus 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
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
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 other 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 annulus fibrosis 10.
In the un-deployed state depicted in
While this invention has been particularly shown and described with references 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.
1. A method of positioning an implant within an implantation site, said implantation site comprising a first region having a tight and/or changing curvature bordered by a second region or regions having minimal or constant curvature, said method comprising:
- placing a relatively flexible region of said implant within said first region;
- placing a relatively stiff or rigid region of said implant within said second region;
- wherein said implantation site is the interior of an intervertebral disc and said implant comprises a barrier for preventing the migration of materials from within the disc toward the periphery of the disc;
- affixing the barrier to tissue in or surrounding the intervertebral disc; and
- deploying the barrier between the nucleus pulposus and the annulus fibrosis of the intervertebral disc.
2. The method of claim 1, wherein said first implantation region is the annulus fibrosis and said second implantation region is a vertebral endplate or endplate cartilage.
3. The method of claim 1, wherein said first implantation region is the posterior lateral corner of the annulus fibrosis and said second region is the posterior or lateral annulus fibrosis.
4. The method of claim 1, further comprising expanding the barrier to an expanded state.
5. The method of claim 1, wherein the barrier further comprises a frame operable to enlarge or expand at least one dimension of the barrier.
6. The method of claim 5, wherein the frame comprises an alloy of nickel and titanium.
7. The method of claim 5, wherein the frame comprises a longitudinal strut and a plurality of radial elements.
8. The method of claim 5, comprising providing a frame with a first end and a second end that extend at oblique angles relative to a longitudinal axis of the frame.
9. A method of positioning an implant within an implantation site, said implantation site comprising a first region having a tight and/or changing curvature bordered by a second region or regions having minimal or constant curvature, said method comprising:
- placing a relatively flexible region of said implant within said first region;
- placing a relatively stiff or rigid region of said implant within said second region;
- wherein said implantation site is the interior of an intervertebral disc and said implant comprises a barrier for preventing the migration of materials from within the disc toward the periphery of the disc; and
- inserting an insertion device into the intervertebral disc at a point located a distance away from a defect in the annular fibrosis of the intervertebral disc and advancing the barrier across the defect.
10. The method of claim 9, wherein said first implantation region is the annulus fibrosis and said second implantation region is a vertebral endplate or endplate cartilage.
11. The method of claim 9, wherein said first implantation region is the posterior lateral corner of the annulus fibrosis and said second region is the posterior or lateral annulus fibrosis.
12. The method of claim 9, further comprising expanding the barrier to an expanded state.
13. The method of claim 9, wherein the implant further comprises a frame operable to mount the barrier.
14. The method of claim 13, wherein the frame comprises an alloy of nickel and titanium.
15. The method of claim 13, wherein the frame comprises a longitudinal strut and a plurality of radial elements.
16. The method of claim 9, further comprising providing a frame with a first end and a second end that extend at oblique angles relative to a longitudinal axis of the frame.
17. The method of claim 9, further comprising affixing at least a portion of the barrier to tissue in or surrounding the intervertebral disc.
18. The method of claim 9, further comprising resisting or promoting tissue ingrowth.
19. A method of positioning an implant within an implantation site, said implantation site comprising a first region having a tight and/or changing curvature bordered by a second region or regions having minimal or constant curvature, said method comprising:
- placing a relatively flexible region of said implant within said first region;
- placing a relatively stiff or rigid region of said implant within said second region;
- wherein said implantation site is the interior of an intervertebral disc and said implant comprises a barrier for preventing the migration of materials from within the disc toward the periphery of the disc; and
- deploying the barrier between the nucleus pulposus and the annulus fibrosis of the intervertebral disc.
20. The method of claim 19, further comprising affixing at least a portion of the implant to tissue in or surrounding the intervertebral disc.
|February 1975
|Stubstad et al.
|April 1975
|September 21, 1982
|March 5, 1985
|August 6, 1985
|May 3, 1988
|May 17, 1988
|September 20, 1988
|Ray et al.
|November 1, 1988
|January 17, 1989
|Bonomo et al.
|June 6, 1989
|Berg et al.
|August 1, 1989
|September 5, 1989
|October 17, 1989
|January 2, 1990
|March 27, 1990
|Lee et al.
|April 17, 1990
|Frey et al.
|April 24, 1990
|June 12, 1990
|Frey et al.
|August 7, 1990
|Hirayama et al.
|September 11, 1990
|Frey et al.
|March 26, 1991
|Fuhrmann et al.
|June 4, 1991
|Kensey et al.
|July 30, 1991
|September 10, 1991
|Bao et al.
|October 1, 1991
|October 22, 1991
|October 29, 1991
|December 10, 1991
|April 28, 1992
|May 26, 1992
|June 16, 1992
|June 23, 1992
|August 25, 1992
|September 15, 1992
|December 15, 1992
|December 15, 1992
|December 15, 1992
|Parsons et al.
|January 5, 1993
|Wilk et al.
|March 9, 1993
|Bao et al.
|April 13, 1993
|Hertzmann et al.
|June 29, 1993
|Kensey et al.
|August 31, 1993
|October 19, 1993
|November 2, 1993
|November 2, 1993
|December 14, 1993
|February 1, 1994
|Kensey et al.
|April 26, 1994
|Stone et al.
|May 17, 1994
|Nash et al.
|June 14, 1994
|Allen et al.
|June 14, 1994
|August 30, 1994
|October 18, 1994
|Rutkow et al.
|November 22, 1994
|November 29, 1994
|de la Torre
|December 6, 1994
|January 24, 1995
|January 24, 1995
|Golds et al.
|March 14, 1995
|Himpens et al.
|March 14, 1995
|Kammerer et al.
|April 11, 1995
|June 20, 1995
|Boyd et al.
|August 1, 1995
|October 10, 1995
|Schultz et al.
|November 7, 1995
|March 19, 1996
|Feagin et al.
|April 16, 1996
|Green et al.
|May 7, 1996
|Heggeness et al.
|May 28, 1996
|Beyar et al.
|July 2, 1996
|Kensey et al.
|July 9, 1996
|Bao et al.
|July 9, 1996
|Navarro et al.
|August 13, 1996
|Kensey et al.
|August 13, 1996
|Parsons et al.
|August 27, 1996
|Green et al.
|August 27, 1996
|September 17, 1996
|October 8, 1996
|Green et al.
|October 8, 1996
|Boyd et al.
|October 29, 1996
|Justin et al.
|November 5, 1996
|December 10, 1996
|Bolduc et al.
|January 7, 1997
|Lock et al.
|March 25, 1997
|Andreas et al.
|April 15, 1997
|Benderev et al.
|April 29, 1997
|Stone et al.
|May 6, 1997
|June 3, 1997
|July 8, 1997
|July 8, 1997
|August 19, 1997
|Hauselmann et al.
|September 2, 1997
|September 23, 1997
|Rosenman et al.
|October 7, 1997
|Bainville et al.
|October 7, 1997
|Bryan et al.
|October 14, 1997
|Janzen et al.
|October 14, 1997
|Yuan et al.
|October 28, 1997
|Jamiolkowski et al.
|November 4, 1997
|Shinn et al.
|December 9, 1997
|Mulhauser et al.
|December 30, 1997
|December 30, 1997
|Biedermann et al.
|December 30, 1997
|December 30, 1997
|February 10, 1998
|Eldridge et al.
|February 10, 1998
|March 10, 1998
|March 17, 1998
|McDonald et al.
|March 24, 1998
|Justin et al.
|March 31, 1998
|Carr, Jr. et al.
|April 28, 1998
|May 5, 1998
|Wood et al.
|May 26, 1998
|June 16, 1998
|Mulhauser et al.
|June 23, 1998
|June 23, 1998
|June 30, 1998
|July 7, 1998
|Kanesaka et al.
|July 21, 1998
|Yoon et al.
|July 28, 1998
|September 1, 1998
|Bao et al.
|September 22, 1998
|October 20, 1998
|Sharkey et al.
|October 20, 1998
|Bolduc et al.
|October 20, 1998
|October 20, 1998
|Ray et al.
|October 20, 1998
|Serhan et al.
|October 27, 1998
|Hart et al.
|November 17, 1998
|Benderev et al.
|December 1, 1998
|Hart et al.
|January 19, 1999
|Benderev et al.
|January 19, 1999
|Zucherman et al.
|February 2, 1999
|February 2, 1999
|Bryan et al.
|March 30, 1999
|Felt et al.
|March 30, 1999
|April 13, 1999
|June 29, 1999
|July 6, 1999
|Husson et al.
|July 13, 1999
|July 27, 1999
|August 10, 1999
|Kensey et al.
|September 21, 1999
|Sharkey et al.
|September 21, 1999
|Pajotin et al.
|September 28, 1999
|Heaven et al.
|October 26, 1999
|Beyar et al.
|October 26, 1999
|Sheffield et al.
|October 26, 1999
|November 9, 1999
|Sharkey et al.
|December 14, 1999
|Bryan et al.
|December 28, 1999
|Sharkey et al.
|December 28, 1999
|February 1, 2000
|Perren et al.
|February 22, 2000
|Asano et al.
|August 15, 2000
|Simmons, Jr.
|October 3, 2000
|Sharkey et al.
|November 14, 2000
|Racz et al.
|May 1, 2001
|Bao et al.
|June 12, 2001
|August 28, 2001
|Bao et al.
|April 16, 2002
|June 11, 2002
|Atkinson et al.
|July 16, 2002
|August 6, 2002
|February 18, 2003
|June 17, 2003
|Keith et al.
|January 17, 2002
|June 20, 2002
|August 15, 2002
|August 29, 2002
|September 5, 2002
|Cauthen, III
|October 10, 2002
|Belef et al.
|October 17, 2002
|November 7, 2002
|December 19, 2002
|Cauthen, III et al.
|December 26, 2002
|January 2, 2003
|February 27, 2003
|April 17, 2003
|Thomas, Jr. et al.
|April 17, 2003
|Ferree et al.
|April 24, 2003
|August 1988
|March 1996
|December 1998
|August 1997
|April 1998
|August 1998
|January 1999
|January 1999
|January 1999
|June 1999
|September 1999
|December 1999
|July 2000
|August 2000
|October 2000
|March 2001
|April 2001
|June 2001
|August 2002
|September 2002
- Tibrewal, S.B., et al., "Lumbar Intervertebral Disc Heights in Normal Subjects and Patients with Disc Herniation," Spine, 11 (5) : 452-454, (1985).
- Goel, V.K., et al., "Mechanical Properties of Lumbar Spinal Motion Segments as Affected by Partial Disc removal," Spine 11 (10) : 1008-1012, (1986).
- Ahlgren, B.D., et al., "Anular Incision Technique on the Strength and Multidirectional Flexibility of the Healing Intervertebral Disc," Spine, 19 (8) : 948-954, (1994).
- Barr, J.S., "Ruptured Intervertebral Disc and Sciatic Pain," J. of Bone and Joint Surgery, 29, (2) : 429-437, (1947).
- Postacchini, F., "Spine Update Results of Surgery Compared with Conservative Management for Lumbar Disc Herniations," Spine, 21 (11) : 1383-1387, (1996).
- Rogers, L.A., "Experience with Limited versus Extensive Disc Removal in Patients Undergoing Microsurgical Operations for Ruptured Lumbar Discs," Neurosurgery, 22 (1) : 82-85, (1998).
- Brinckmann, P., et al., "Change of Disc Height, Radial Disc Bulge, and Intradiscal Pressure From Discectomy An in Vitro Investigation of Human Lumbar Disc," Spine, 16 (6) : 641-646. (1991).
- Balderston, R.A., et al., "The Treatment of Lumbar Disc Herniation: Simple Fragment Excision Versus Disc Space Curettage," J. of Spinal Disorder, 4 (1) : 22-25 (1991).
- Hanley, E.N., Jr., et al., "The Development of Low-Back Pain After Excision of a Lumbar Disc," J. of Bone and Joint Surgery, 71A (5) : 719-721, (1989).
- Tullberg, T., et al., "Radiographic Changes after Lumbar Discectomy," Spine, 18 (7) : 843-850, (1993).
- Heggeness, M.H., et al., "Discovery of Lumbar Discs after Surgical Treatment for Disc Herniation," Spine, 22 (14) : 1606-1609, (1997).
- Kayama, S., et al., "Incision of the Anulus Fibrosus Induces Nerve Root Morphologic, Vascular, and Functional Changes," Spine, 21 (22) : 2539-2543, (1996).
- Yasargil, M.G., "Microsurgical Operation of Herniated Lumbar Disc," p. 81.
Type: Grant
Filed: Sep 5, 2002
Date of Patent: Apr 26, 2005
Patent Publication Number: 20030014117
Assignee: Intrinsic Therapeutics, Inc. (Woburn, MA)
Inventors: Gregory H. Lambrecht (Natick, MA), Robert Kevin Moore (Natick, MA), Thomas Banks (Santa Barbara, CA), Russel J. Redmond (Goleta, CA), Claude A. Vidal (Santa Barbara, CA)
Primary Examiner: Corrine McDermott
Assistant Examiner: Thomas Barrett
Attorney: Knobbe, Martens, Olson & Bear, LLP
Application Number: 10/237,332


text:
They've been partnering up for eight years and eight models so far, but now they've got the ninth co-branded Harley-Davidson Ford F-150...and it's still just what we've never wanted — another pickup truck that can't actually hold a Harley without a liftgate extender. One of these days the boys n' girls at FoMoCo will realize it's not just about naming it Harley, but actually making it useful for owners of a Harley. In the meantime enjoy the fact that you can get a supercharged 5.4-liter V8 with an auto tranny delivering 450 hp and 500 lb-ft of torque. Of course that's only if you add the $6500 Saleen supersharger option to the base-level F-150 Harley package which starts at $37,210. If not, you just get an expensive truck that says "Harley-Davidson" on the side of it as though it's the "Hard Rock Cafe" of pickup trucks. Full press release from FoMoCo after the jump.
SUPERCHARGED 2007 FORD F-150 HARLEY-DAVIDSON PACKS A POWERFUL PUNCH * Ford F-150 supercharged 5.4-liter V-8 mated to a 4-speed automatic transmission delivers 450 horsepower and 500 pounds-feet of torque. * Ford responds to customer demand bringing F-150 performance concept to market in eight months. * Ford-Harley co-branding partnership flourishes - with more than 60,000 pickups sold since 1999.
DEARBORN, Mich., May 23, 2007 - America's best-selling, most capable full-size pickup now delivers the horsepower to make it one of the most powerful half-ton pickups on the market. The 450 horsepower supercharged Ford Harley-Davidson™ F-150 Super Crew 4x2 hits the road this summer.
Born from tremendous customer reaction to the F-150 performance truck concept that was on display at the November 2006 SEMA show, the supercharged F-150 packs the extra power punch that Ford truck enthusiasts have been demanding.
"Ford is the truck leader because we pay attention to what our customers want and move quickly to meet their needs," said Ben Poore, Ford Truck group marketing manager. "They told us they wanted a performance equipped truck so we worked with Saleen to bring the supercharged Harley-Davidson™ F-150 to market in rapid fashion."
The supercharged Harley Davidson™ F-150 is available in Ebony Black or Dark Amethyst with plenty of gleaming chrome, 22-inch oversized wheels and tires, and a custom scalloped stripe that runs along the beltline that creates a glued-to-the-ground appearance. "Harley-Davidson" script runs along the bedside in three-dimensional chrome letters. Blacked-out headlamps and a unique chrome billet grille give it a distinctive, bold front-end.
Among other highlights:
* The SALEEN supercharger option is available through Ford dealers for $6500 MSRP. Base F-150 Harley-Davidson™ pricing starts at $37,210 MSRP including $925 destination and delivery.
* The twin-screw supercharger is the same style as the one in the Shelby GT-500.
* A dual-stage water-to-air intercooler increases the supercharger's efficiency and adds performance by cooling the intake air.
* The volume from the exhaust is cranked up into a sustained growl.
* An available gauge pod with boost (PSI) and air-charge temperature (ACT) gauges monitors the system's performance.
The 2007 Harley-Davidson™ F-150 truck is the ninth model to emerge from a Ford/Harley-Davidson™ partnership that began in 1999. The co-branding of the two storied 104-year-old companies has proven to be a successful formula with total sales of Ford F-Series Harley-Davidsons™ of more than 60,000 units.
About Ford Motor Company
Ford Motor Company, a global automotive industry leader based in Dearborn, Mich., manufactures or distributes automobiles in 200 markets across six continents. With more than 280,000 employees and more than 100 plants worldwide, the company's core and affiliated automotive brands include Ford, Jaguar, Land Rover, Lincoln, Mercury, Volvo, Aston Martin and Mazda. The company provides financial services through Ford Motor Credit Company. For more information regarding Ford's products, please visit www.fordvehicles.com.
About Harley-Davidson®
Harley-Davidson, Inc. is the parent company for the group of companies doing business as Harley-Davidson Motor Company, Buell Motorcycle Company and Harley-Davidson Financial Services. Harley-Davidson Motor Company produces heavyweight street, custom and touring motorcycles and offers a complete line of motorcycle parts, accessories, apparel and general merchandise. As a subsidiary of Harley-Davidson, Inc., Buell Motorcycle Company produces sport motorcycles in addition to motorcycle parts, accessories and apparel. Harley-Davidson Financial Services, Inc. provides wholesale and retail financing and insurance programs to Harley-Davidson/Buell dealers and customers.
Ezra Rode a Harley : The NY Times on the Ford F150 Harley Davidson; Sometimes You Feel Like A HOG, Sometimes You Don't: The 2007 Ford Harley-Davidson F-150 Super Crew [internal]


text:
JEFFERSON CITY, T.N. - Carson-Newman keeper Sarah Tompkins turned away all 14 shots on goal fired by Pfeiffer University en route to a 3-0 shutout on Tuesday afternoon. The Lady Eagles improve to 4-8-1 overall while the Lady Falcons, who took 18 shots total, drop to 6-8-1 on the year.
Alyssa Wombwell led the Lady Falcons with six shots on the day, five on goal, as eight different players took shots with none being able to find the back of the net.
Carson-Newman jumped on the board early just 3:36 in as Bianca Hall scored right off of a corner kick to the far post. The Lady Eagles would hold that advantage add the half before adding two more for insurance in the second. Maleya Garrison (50') and Trenna Howell (67') provided the breathing room for the Lady Eagles.
Pfeiffer returns to Conference Carolinas action on Saturday with a crucial road matchup at Erskine. Kickoff is set for 2:00 p.m. in Due West.


text:
We're biased, but we believe college football is the most popular sport in America only behind the NFL. However, 2012 stadium attendance numbers don't exactly reflect that. Per a story from al.com, college football attendance dipped to an average of 45,274 fans per game, the lowest since 2003.
Average attendance in college football peaked in 2008 with 46,739, so 2012's numbers represent roughly a 3 percent decrease. This was the second year in a row that college football stadiums collectively averaged less than 46,000 fans per game. Some drops were minor, while others — Penn State and Tennessee, for example — experienced a 5 percent drop.
On the other hand, UCLA (21 percent) USC (18 percent) and Vanderbilt (15 percent) all saw significant increases.
You can check out the story and full chart HERE.
The reason? You can probably point to a few factors. Economy combined with ticket prices can be an easy deterrent when the experience of watching football at home is as great as its ever been. When you add in some cruddy non-conference games, fans simply aren't going to shell out their hard-earned dollars for a blowout win over, say, South Alabama.


text:
Rebecca (Age 26)
White Salmon, WA
About REBECCA :
"A finished nymphomaniac that loves a total spectrum of sexual perversions. It's standard to have sex five or four times a day with partner. What I love most is be powerfully taken advantage of and to act as a little girl. I totally love sucking cock and anal sex and also the preference of my own pussy. Adore to have oral, vaginal, and anal sex with female partner."
Damaris (Age 27)
Pacific, WA
About DAMARIS :
"I'm an honest, loving sexy woman, who'sn't getting what she wants.
I love to get naked and have sex uhm lots of sex.. I'm incredibly into oral.
Love to be with a guy who takes control and puts me on my back and just has his way with me..
Can you see my pussy, I would love for you to bury your face in here….xxxxx"
Leoma (Age 29)
Kapowsin, WA
About LEOMA :
"Hey I'm only 20 and have been in a relationship for 4 years.He was my first and only love sort off. He will be getting into the major leagues pretty soon and I dont want to be part of that world.
Plus I'm really curious to see what else is out there in this great big world for me.
Rasheeda (Age 30)
Starbuck, WA
About RASHEEDA :
"Yeah I Love Having Fun with fruit ???? Apart from obviously being crazy about sex I am also vibrant witty at times and curious…You must have a really high sex drive and urge. So yeah for the time being I'm just "using" fruits 'because a womans life sure can be hard at times!!"


text:
Schumaker brings versatile, veteran presence
GOODYEAR, Ariz. -- Skip Schumaker once played regularly at second base for the Cardinals but has since made the transition into a veteran role player. It's a gig that can be as equally thankless as it is valuable -- especially if he happens to be the one summoned in the ninth inning to pinch-hit against a closer throwing 98 mph.
Being a do-it-all utility player for the Reds is something Schumaker isn't taking lightly.
GOODYEAR, Ariz. -- Skip Schumaker once played regularly at second base for the Cardinals but has since made the transition into a veteran role player. It's a gig that can be as equally thankless as it is valuable -- especially if he happens to be the one summoned in the ninth inning to pinch-hit against a closer throwing 98 mph.
Being a do-it-all utility player for the Reds is something Schumaker isn't taking lightly.
"There's no tougher role for position players than a bench role," Schumaker said. "When you play every day, you know you're getting four at-bats tomorrow. If you had a bad day, you know you're getting four at-bats the next day. If you're a bench guy and get four at-bats and might not play for a while, those four at-bats are really meaningful. You have to be pretty strong-minded as a bench player."
Schumaker can serve the Reds as a backup second baseman and play all three spots in the outfield. He even made two relief appearances as a pitcher for the Dodgers last season.
Manager Bryan Price senses that Schumaker can bring even more to the table, providing some intangibles.
"Really good energy and a good situational player," Price said of Schumaker. "He understands the game and understands how he affects it in a positive way. We love those underappreciated guys that are just really good baseball players. He gets on base. He has a good feel for the strike zone. He works extremely hard on his defense and his baserunning.
"He's a very gritty-type player that brings a certain attitude. There is no laissez-faire with him. He understands that one of his tools is his character as a baseball player."
Signed a two-year, $5 million contract with the Reds in November that came with a $2.5 million club option for 2016, Schumaker has mostly worked with the outfielders in the early days of Spring Training. He could be added protection in center field behind rookie Billy Hamilton, especially against right-handed pitching. He also has 456 games of experience playing at second base, where he played during the 2011 World Series championship season in St. Louis.
Schumaker isn't expecting to see much time at second base for the Reds, however.
"In my opinion, Brandon Phillips is the best second baseman in the big leagues," Schumaker said. "This guy can really play. He's a pain to play against. You never want to see him up. Every ball hit to the right side is going to be caught. You plan on him playing 150 games. I know my role. That's to be ready when the time is needed. … When guys get into trouble is when they don't know their role. They think they're someone they're not. I get it and I'm excited for it."
A left-handed hitter, Schumaker batted .263 with a .332 on-base percentage in 125 games last season for the Dodgers, and hit both of his home runs for the year only five days apart in July. During his career, he is a .285 hitter with a .344 on-base percentage -- including a .300 average vs. right-handers.
Schumaker is now assimilating into a new clubhouse for the second year in a row. While he knew no one heading into his lone season at Los Angeles, he was enticed to Cincinnati by his former Cardinals general manager, Reds GM Walt Jocketty. Left fielder Ryan Ludwick is also a former Cardinals teammate who knows what the 5-foot-10 Schumaker brings.
"He's a guy that comes prepared every day," Ludwick said. "He's worked his way to the big leagues and a guy that doesn't take anything for granted. The reason he's been here as long as he has is because he works at it. He's here early doing defensive work. He's there after we're done practicing, in the cage hitting."
There is also a familiarity for Schumaker in joining players he once played against several times each year while with the Reds' chief rival in the National League Central.
"Here, it's a family atmosphere. It's easy to fit in. If you don't fit in here, you've got a problem. It's been a nice transition," Schumaker said. "I think that building relationships is the key to building trust during the season. The last thing you want to do as a new player in the clubhouse of a team that has won 90 games a few years in a row and has established guys, is be the loud guy and open your mouth and try to take control of something that's not yours."
The rivalry the Reds have had with the Cardinals the last few years has caused a variety of emotions -- from excitement, euphoria and satisfaction to angst, dejection and resentment. Schumaker experienced it from the other side in St. Louis.
"Because of the past history of benches clearing and all that stuff, to be in the same clubhouse is strange, initially," Schumaker said. "It was a long time ago. I feel like we're all on the same page now. Being on the other side, I'm not going to lie, was a little bit different."
At the end of the day, to Schumaker, there was still a healthy respect for the competition between the two teams on the field.
"It felt like a playoff atmosphere every time. You knew the Reds would be at the top of division," Schumaker said. "It was always going to be a tough series. With the pitching staff they had, you knew it was not going to be an easy weekend. Hopefully that continues. The Reds aren't an easy team to play the last few years."
Schumaker wants to do his part to keep the Reds a tough foe for any opponent, including the Cardinals. He was enticed, he said, by a couple of contending teams but felt the fit in Cincinnati was the best one -- professionally and personally.
"I know what they're all about," Schumaker said. "I know all about the Midwest lifestyle and morals and values for my family and winning was a huge factor for me. I'm 34 and later in my career. I'm not looking to rebuild. I get what the role is and I want to win. I'm used to winning."
Mark Sheldon is a reporter for MLB.com. Read his blog, Mark My Word, and follow him on Twitter @m_sheldon.