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To help class members recognize and avoid hypocrisy and thus strengthen their commitment to Jesus Christ.
Read, ponder, and pray about the following scriptures:
John 12:1–8. Jesus travels to Bethany, where Mary anoints his feet. Judas criticizes Mary's use of expensive oil.
Matthew 21:1–11. Jesus returns to Jerusalem for the Feast of Passover. He makes a triumphal entry into the city, riding on a colt, the foal of an ass.
Matthew 21:23–46. The chief priests and elders come to Jesus in the temple and challenge his authority. Instead of answering their questions, Jesus tells them the parable of the two sons and the parable of the householder.
Matthew 22:15–46. The scribes and Pharisees try to trap Jesus into saying something that will allow them to discredit and condemn him.
Matthew 23. Jesus condemns the scribes and Pharisees for their hypocrisy.
- a.
Additional reading: Matthew 26:6–13; Mark 11–12; 14:3–9; Luke 11:37–51; 19:29–48; 20; John 12:12–18; Bible Dictionary, "Pharisees," 750; "Sadducees," 767; "Spikenard," 776.
If you use the attention activity, bring one cup that is clean outside and inside and a similar cup that is clean outside but dirty inside.
If the picture Triumphal Entry (62173; Gospel Art Picture Kit 223) is available, use it during the lesson.
Suggestion for teaching: As you prepare to teach, you should do more than merely read the assigned scriptures. Study each scripture block at least three times. The first time, read it to comprehend what the passages contain. Then study it more carefully, looking for principles, doctrines, and significant events. Then read it again, determining which passages will best meet class members' needs and planning ways to discuss those passages.
Suggested Lesson Development
Attention Activity
As appropriate, use the following activity or one of your own to begin the lesson.
Display the two cups (see the "Preparation" section). Make sure class members see only the outside of each cup.
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Which of these two cups would you rather drink from?
Show class members the inside of each cup.
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Now which cup would you rather drink from? Why?
Explain that Jesus compared the Pharisees to a cup that is clean outside but dirty inside (Matthew 23:25–26). The Pharisees paid a great deal of attention to outward ordinances and actions that would make them appear righteous, but they were not as concerned with actually being righteous in their hearts. For this Jesus referred to them as hypocrites. This lesson will discuss the Savior's condemnation of hypocrites—people who try to appear righteous but who do not try to live righteously.
Scripture Discussion and Application
As you teach the following scripture passages, discuss what they teach about avoiding hypocrisy. Encourage class members to focus on identifying and correcting hypocrisy in their own lives, rather than on identifying it in others.
1. Mary anoints Jesus' feet.
Read and discuss John 12:1–8. Explain that five days before his Crucifixion, Jesus spent an evening with his friends at Bethany. There Mary, the sister of Martha and Lazarus, anointed the Savior's feet with spikenard, a costly ointment (John 12:1–3). Elder James E. Talmage explained why she did this:
"To anoint the head of a guest with ordinary oil was to do him honor; to anoint his feet also was to show unusual and signal regard; but the anointing of head and feet with spikenard, and in such abundance, was an act of reverential homage rarely rendered even to kings. Mary's act was an expression of adoration; it was the fragrant outwelling of a heart overflowing with worship and affection" (Jesus the Christ, 3rd ed. [1916], 512).
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Mary anointed the Lord's feet to show her love for him. How do we show our love for the Lord?
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Mary's actions were criticized by Judas. What did he say should have been done with the ointment? (See John 12:4–5.) How was Judas a hypocrite? (See John 12:6. If you did not use the attention activity, use the information in the activity to explain what a hypocrite is. Point out that a later part of the lesson will discuss how the Savior feels about hypocrites.)
2. Jesus makes a triumphal entry into Jerusalem.
Read and discuss Matthew 21:1–11. Display the picture of Jesus' triumphal entry. Explain that when Jesus returned to Jerusalem for the Passover, many people came to see him because they heard that he had raised Lazarus from the dead (John 12:17–18). As Jesus approached the city, he was greeted by a great multitude of people who spread their garments in his path and hailed him with palm branches, an honor usually reserved for kings and conquerors. This fulfilled a prophecy by Zechariah (Zechariah 9:9) and was a further witness that Jesus was the promised Messiah.
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What impresses you about the account of Jesus riding humbly yet triumphantly into Jerusalem? How do you think you would have felt if you had been there that day?
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The people who hailed Jesus with palm branches recognized him as a prophet and king (Matthew 21:9, 11; Luke 19:38), but others misunderstood his mission or rejected him. In what ways do people misunderstand or reject the Savior today? How can we more fully accept and welcome him into our lives?
3. Jesus gives the parable of the two sons and the parable of the householder.
Read and discuss selected verses from Matthew 21:23–46.
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In the parable of the two sons, how did the first son prove to be more obedient than the second son? (See Matthew 21:28–30.) How did Jesus apply this parable to his listeners? (See Matthew 21:31–32; see also the Joseph Smith Translation of Matthew 21:32 in footnote 32d.) How were the publicans and harlots like the first son? (Initially they rejected the commandments of God, but when John preached to them, they accepted Christ and repented of their sins.) How were the chief priests and elders like the second son? (They claimed to follow God, but they rejected John's teachings and rejected Jesus even after they saw him in person.) How was the second son a hypocrite?
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What promises have we made to the Lord? (You may want to discuss promises such as those we make at baptism, when taking the sacrament, and when receiving the priesthood.) How are we sometimes like the second son? How can we strengthen our commitment to the Lord? How can we help each other keep the promises we have made to the Lord?
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In the parable of the householder (Matthew 21:33–41), who is represented by the householder, or lord of the vineyard? (Our Father in Heaven.) By the husbandmen? (The Jewish religious leaders of Jesus' day.) By the servants? (The prophets.) By the son killed by the husbandmen? (Jesus Christ.)
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How were the Jewish religious leaders like the husbandmen? What did the chief priests and elders acknowledge would happen to the husbandmen when the lord of the vineyard came? (See Matthew 21:41.)
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Who was "the stone which the builders rejected"? (See Matthew 21:42; Acts 4:10–12.) Who were the builders? What did Jesus say would happen to the builders who rejected the cornerstone? (See Matthew 21:43–44.) How might Jesus' words in verse 43 apply to us?
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How did the chief priests and Pharisees respond when they realized that Jesus was speaking about them in these parables? (See Matthew 21:45–46.) How can we overcome any pride or indignation we may feel when we are called to repent?
4. The scribes and Pharisees try to trap Jesus.
Read and discuss selected verses from Matthew 22:15–46. Explain that these verses record three times when the Pharisees and Sadducees tried to trap Jesus into saying something that would allow them to discredit and condemn him.
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How did the Pharisees first try to trap Jesus? (See Matthew 22:15–17. Explain that if Jesus said yes to the question, they could accuse him of supporting the hated Roman government. If he said no, they could accuse him of rebellion against the government.) What did Jesus perceive about his questioners? (See Matthew 22:18. Point out that the Lord knows our hearts and thoughts. We cannot hide anything from him.) How did Jesus answer the question? (See Matthew 22:19–21.) How can this answer guide us in giving allegiance to God and to earthly governments? (See also Articles of Faith 1:12.)
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How did the Sadducees try to trap Jesus? (See Matthew 22:23–28.) How were the Sadducees hypocritical in their question? (See Matthew 22:23. They pretended to be concerned about marriage in the resurrection, but they did not believe in resurrection.) How did Jesus answer their question? (See Matthew 22:29–30. Explain that Doctrine and Covenants 132:15–16, 19 clarifies Jesus' teaching. Those who do not make and keep the covenants of temple marriage will be single in heaven. For those who do make and keep these covenants, marriage will last for eternity.)
- •
What was the third attempt to trap Jesus? (See Matthew 22:34–36.) How did Jesus' response resolve this question? (See Matthew 22:37–40.) Why do you think these two great commandments are so important? What can we do to more fully live these commandments?
Elder Howard W. Hunter said: "He loves the Lord with all his heart who … is ready to give up, do, or suffer anything in order to please and glorify him. He loves God with all his soul … who is ready to give up life for his sake and to be deprived of the comforts of the world to glorify him. He loves God with all his strength who exerts all the powers of his body and soul in the service of God. He loves God with all his mind who applies himself only to know God and his will, who sees God in all things and acknowledges him in all ways" (in Conference Report, Apr. 1965, 58; or Improvement Era, June 1965, 512).
5. Jesus condemns the sin of hypocrisy.
Read and discuss selected verses from Matthew 23.
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The scribes and Pharisees paid tithing, gave to the poor, attended worship services, and went regularly to the temple. What caused the Lord to condemn them? (See Matthew 23:5, 14, 23–28. They did these things not out of faith, but out of a desire to be seen as righteous by others.) What "weightier matters" did the Lord say they had omitted? (See Matthew 23:23.) How can we ensure that we do not omit these "weightier matters" in our own lives?
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How might we as Church members sometimes be hypocrites? (For example, when we attend Church meetings we may be more concerned with being seen by others than with worshiping God. We may complain about Church assignments where we do not receive much attention for our service. We may sustain our Church leaders and then criticize their decisions.)
- •
What can we do to avoid hypocrisy? Ask class members to silently consider these questions: Am I paying tithing, giving to the poor, attending my meetings, and serving others for my own glory or for the glory of God? In all my actions, do I seek to draw closer to my Father in Heaven and Jesus Christ?
Encourage class members to examine their lives for hypocrisy and seek to eliminate it. Testify that a sincere desire to serve and obey Jesus Christ, motivated by love for and faith in him, will bring us closer to him and increase our love and faith.
Additional Teaching Ideas
The following material supplements the suggested lesson outline. You may want to use one or more of these ideas as part of the lesson.
1. Jesus curses a barren fig tree, a symbol of hypocrisy
Read and discuss Matthew 21:17–22. Explain that another symbol of hypocrisy was the fig tree Jesus saw on his way into Jerusalem.
- •
What did Jesus do when he found that the tree had many leaves but no fruit? (See Matthew 21:19.) How was the fig tree like a hypocrite?
Elder James E. Talmage explained: "[The tree] was made the object of the curse and the subject of the Lord's instructive discourse, because, having leaves, it was deceptively barren. Were it reasonable to regard the tree as possessed of moral agency, we would have to pronounce it a hypocrite; its utter barrenness coupled with its abundance of foliage made of it a type of human hypocrisy" (Jesus the Christ, 3rd ed. [1916], 527).
2. Video presentation
The second segment of "New Testament Customs," a selection from New Testament Video Presentations (53914), explains the Jews' use of phylacteries and fringes. If you did not show this segment in lesson 9, you could show it now to help class members understand Matthew 23:5 ("they make broad their phylacteries, and enlarge the borders of their garments"). Discuss how these items were symbolic of the scribes' and Pharisees' hypocrisy.
3. "They loved the praise of men" (John 12:43)
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John recorded that many people who believed in Jesus would not admit to their belief because "they loved the praise of men more than the praise of God" (John 12:42–43). How do we sometimes become too concerned with receiving "the praise of men"? What are the consequences of seeking "the praise of men"? How can we overcome the desire to seek praise and recognition from others? (See D&C 82:19; 88:67.)


text: Oneida Daily Dispatch Thursday, Aug. 20, 1998 ONEIDA Alexander A. "Alex" Cerio, 83, of 3924 Pratt Drive, died Tuesday, Aug. 18, 1998, in the Veteran's Administration Medical Center, where he had been a medical patient since July II, Mr. Cerio was born on May 23, 1915, in Canastota, the son of Carmen and Rosa Notatomaso Cerio. A lifelong resident of the area, he graduated from Canastota High School. He was also a graduate of St. Michael's College, University of Toronto and the Albany Law School. He married Yvonne Mahony in 1946. She died in 1975. He then married Marjorie McPherson Chamberlin on Aug. 18, 1979, in St. Agatha's Church, Canastota. Mr. Cerio operated his own law practice in Canastota from 1946 to 1997, and had served as the attorney for the town of Lenox, Canastota Central Schools and the Oneida Lake South Shore Sewer District. He was an Army veteran of World War II, where he served in the European Theatre and received the Bronze Star. Mr. Cerio was a member of St. Patrick's Church ofOneida, the Madison County Bar Association and the Emmaus Ministries. He was also a 54-year member and Past Commander of the Charles Miller American Legion Post No. 140 of Canastota. Mr. Cerio served as board chairman for Madison County Catholic Charities and Madison County RSVP. He also did extensive volunteer work with the RSVP program tax preparation services, St. Patrick's Bingo team, Karing Kitchen and the Prison Ministries Voltunteers. In 1986, Mr. Cerio was presented the Outstanding Citizen Award by the Charles Miller American Legion Post No. 140 of Canastota for dedication in service to the community. Surviving are his wife; two daughters and one son-in-law, Rosemary McGraw of Syracuse and Susanna and Robert Sandle of Farmington; two stepdaughters and one stepson-in-law, Cherry Foster of Vestal and Masha and Russell Belyavski- Frank of Greencastle, Ind.; two stepsons, George Chamberlin of Colorado Springs, Colo. and Lt. Col. Brooks Chamberlin of Heidelberg, Germany; one sister, Jennie DeVencenzo of Canastota; three grandchildren, Matthew Sandle, Erin Marie Sandle and John MeGraw; six step-grandchildren, Shannon Karski, Erin Foster, Sean Foster, George Chamberlin Jr., Grant Chamberlin and Shea Marie Chamberlin; and several nieces and nephews.

subset: commoncrawl


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- Inicio
- Qué Hacemos
- Temas
- Acerca de Milamex
- Contáctanos
- English
Milamex has a diverse range of activities, including a growing publications ministry, all developed over many years as a result of its work throughout Mexico and Latin America. This page offers a short summary of each activity we currently provide.
Click through to the microsite of each ministry below to learn more:
From the courses for Christian writers and cartoonists to the popular Gala de Belleza sponsored by Prisma magazine, Milamex hosts a variety of courses and events annually to meet the needs of the Christian individual and church today.
Find out about forthcoming courses and special events (in Spanish) here.
Prisma is a magazine for the whole family. It has real testimonies of lives that have been changed by the Lord, articles that offer practical advice and solutions to family problems based on biblical principles, short stories for all ages, and frequently it has a photonovel which has proven to be a great tool in evangelizing. Prisma is an essential item for the Christian home with articles of interest for the whole family.
Prisma magazine started in 1969. Today, Prisma is published every other month and is enjoyed throughout Mexico, and the rest of the Americas.
Visit the Prisma microsite (in Spanish) for more information.
Reporting what the secular press often ignores, Noticiero Milamex keeps the Christian informed about what God is doing throughout Latin America and the wider world. It is like a modern book of Acts, sharing stories of God's blessings, and also news of persecution, evangelism, missions and other situations that motivate us directly to pray.
Since its beginning in 1969, the Noticiero Milamex is a reliable publication and an essential window for Latin Americans to keep in touch with the news which affect the Christian world today.
From January 2010, Noticiero Milamex became an online publication.
Visit the Noticiero Milamex microsite or go directly to the external Noticiero Milamex website (both in Spanish) for more information.
With relatively few Christian books originating from Latin American authors, books published under the Ediciones Milamex label offer a wide range of Christian genres intended to bless, educate and entertain — all written from within a Latin American context.
A relatively young venture, the birth of Milamex's own book label in 2002 is giving a previously unsung voice to talented Latin American authors, and addressing the issues relevant to Latin American Christians today.
For more information about our books, please take a look at our catalogue at the bottom of this page.
Milamex has founded two camps in rural Mexico for the benefit of families and Church groups — Kikotén in the mountains of Huitzilac, Morelos, and Kikomar on the Gulf of Mexico, near Tuxpan, Veracruz. With so many families living in smog polluted, sprawling urban cities, these camps provide an essential escape to experience the fresh air and outstanding natural beauty of God's creation.
Of interest to Christian work groups, Kikomar welcomes groups who will help to improve the infrastructure of the camp. Groups must be prepared to provide project monies, as the camp has no steady income at this point. Kikomar can be the perfect wind-down or gear-up location for a group working elsewhere in Mexico but wishing to enjoy a couple of days at the beach.
To enquire about availability of dates, or to see what projects we could use your work team to complete, please contact us and we will pass you enquiry on to the Kikomar team.
Visit the Camps microsite (in Spanish) for more information.
There is so much more that we as a ministry would like to do, from setting up a Radio station to opening a Christian daycare center, a retirement center and a Counseling center, but at this point we do not have the financial or personnel resources to make these dreams come true.
There are many ways in which you can help Milamex. If you would like to find out how you can help, see How to Support Milamex.
© 2017 Milamex. Todos los Derechos Reservados | Inicio | Acerca de la Página Web | Contáctanos


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Open House Meetings - Dvision of Wildlife
Saturday, March 3, 2012 12:00 pm - 3:00 pm
The Ohio Department of Natural Resources' (ODNR) Division of Wildlife is holding open house meetings in all five districts to discuss season dates and bag limits of game species, which will include Ohio's most popular game animal, the white-tailed deer. The meetings will be Saturday, March 3, from 12 – 3 p.m. and are open to the public.
"Anyone interested in providing input and participating in Ohio's professional wildlife management process is welcome to attend," said Scott Zody, chief of the Division of Wildlife. "Each open house location will have a fish and wildlife biologist as well as law enforcement officers available to answer questions."
Public input gathered at these open houses will be forwarded to the division's central office and considered during the formulation of regulations.
For more information or directions to the open houses, visit the Division of Wildlife's website at wildohio.com or call 800-WILDLIFE (945-3543).
Open House Location Information for March 3:
•Central Ohio - Wildlife District One Office, 1500 Dublin Road, Columbus, 614- 644-3925
•Northwest Ohio - Wildlife District Two Office, 952 Lima Avenue, Findlay, 419-424-5000
•Northeast Ohio - Wildlife District Three Office, 912 Portage Lakes Drive, Akron, 330-644-2293
A statewide hearing on all proposed rules will be held on Thursday, March 8, at 9 a.m. at the Division of Wildlife's District One office, located at 1500 Dublin Road in Columbus. This hearing is open to the public and input is permitted.
After considering public input, the Ohio Wildlife Council will vote on the proposed rules during the April 4 meeting.
ODNR ensures a balance between wise use and protection of our natural resources for the benefit of all. Visit the ODNR website at www.ohiodnr.com.
« Back to Calendar


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Julia Kelly – Babe of the Day
Get to know this Vine star a bit better.
Get to know this Vine star a bit better.
One of the most popular actresses in the adult-film business -- and for good reason.
A cosplaying pro and all-around hottie.
A true internet wonder -- with a great body.
The very definition of blond bombshell.
She may be from the cold, cold north, but she's definitely bringing the heat.
From Hometown Hottie to Queen of (Our) Hearts.
Be nice, or she'll DDT you.
"Wears bikinis well" is a fine skill indeed.
Bikini model. Playmate. Brazilian. (As in, her country of origin, not ... you know. Although maybe?)
We wouldn't mind if the Rain fell down on us.
Fair warning: expect some dangerous curves ahead.


text:
Artist description:
This is my Oc Gwen,she went in Japan (vacation),She bought a kimono for 500$ and she made herself a new hairstyle!!!Hope u like it!Guess wat i wrote above her head :D
Java Draw Created Nov 22, 2011 460 x 640px Unless noted Copyright 2011 WildAngel.
We encourage you to submit a comment and let the artist know what you think of this drawing. Please log in or join to post a comment.
Post a comment
Very cool! I like how kimonos look :3 Nice character!
I love her expression as well as her beautiful kimono($500wow that's expensive) and new hairstyle :D 5 hearts ^^
Gwen has blue eyes? O.o (I guess they change color :p) Did you write "Gwen" above her head? Lol. xD But you drew her so beautifully here. :D I am in the process of drawing her for you btw. :) I adore her hair, kimono and expression here! 5/5 and fave
i learn japanese at school ,you mix the hiragana and katakana alphabet here. it says "ka u e n" . kauen is gwen ! japan dont have the "we" alphabet. :) lol i thought this drawing is for me since my dad will give me a roseo kimono because i score exam
Awsome picture Wild :D And I LOVE her new hairstyle! And her Kimono is Awsome! I also love the crimson fan behind her :D And her Aquamarine eyes look amazing!I dont read japanese but, does it mean Gwen or Japan?I love all of the details! 5h fave coll
VERY pretty!!! What does OC stand for? I think it is something like an avatar? 5h!!
It stands for Origanal Character ;)
AWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWW she'sss cute and wow the kimono is 500$ its too small for her[the money im mean] :DDDDDDDDDDDDDDDDDd 5/5


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Annali dell'Istituto Superiore di Sanità
Print version ISSN 0021-2571
Ann. Ist. Super. Sanità vol.47 n.1 Roma Jan. 2011
A critical evaluation of the process of drug discovery and evaluation: is the current approach the best possible one?
Enrico GaraciI; Guido RasiII
IPresident of the Istituto Superiore di Sanità, Rome, Italy
IIDirector General of the Agenzia Italiana del Farmaco, Rome, Italy
The molecular revolution was supposed to accelerate the process leading to the rational design of the drug. The sequencing of the human genome few years ago raised widespread hope in the treatment of disease created by increased investment in biomedical research. But this goal failed to be achieved. Instead, 2000 outlined the beginning of a fall in new drug submission to regulatory agencies worldwide.
At a time when basic biomedical knowledge is dramatically increasing, the gap between bench discovery and bedside application appears to be expanding. This means that fewer new products can be approved and made available to patients. There is concern that hoped-for advances in medicine and new treatments for diseases may never materialize. What's wrong then?
According to Thomas Kuhn (The structure of scientific revolutions, 1962), "when a prevailing paradigm fails to make productive predictions then the difficulty may lie with the paradigms on which the research is based". This means that our current approach may need to be revisited.
For the past 100 years Western biomedical science has stood on two philosophical pillars: the anatomical paradigm of medicine (organ-specific problems are the result of tissue specific protein and gene defect), and Mendelian paradigm of genetics (specific for nuclear DNA genes). A new paradigm at least for the common age-related diseases must be generated that encompasses the strengths of Mendelian and anatomical paradigm with the energetic paradigm and the mtDNA qualitative paradigm (DC Wallace, Genetics 2008).
Another paradigm that has dominated drug discovery but that may need to be reconsidered is the concept of designing drugs able to act on individual drug targets. Based on the assumption that designing very selective ligands will lead to safer and more effective drugs, most modelling efforts and even animal or clinical trials are typically designed to address a single disease target. In spite of the (theoretically) high risk/benefit profile of target-based drugs, however, toxicity is still a leading cause of attrition at all stages of the drug development process, and efficacy is not as expected, as shown by the frustratingly poor discovery of new disease-ameliorating molecules. According to these considerations, the network pharmacology may represent the next paradigm in drug discovery (AL Hopkins, Nature Chem Biol 2008).
Our "regulatory" mission to favor the delivery of safe and efficacious new treatments to the patients who need them is thus increasingly difficult to be accomplished.
Furthermore, the above uncertain and unsatisfactory scenario means that, as regulators, we have to assume very difficult decisions in the absence of ideal information. For instance, considering that our financial resources in health care are limited, we have to cope with uncertainty on deciding on drug pricing and reimbursement.
For regulatory bodies, significant challenges in this new scenario include the development and validation of new possible regulatory approaches. Our ambition, in this context, is to parallel the science walk and to promote the scientific debate in the field of drug discovery and evaluation.
Of course, to ensure a timely uptake of innovation in this area, scientists from academia and industry will have to share with regulators advances in this direction. Finally, to fully accomplish our mission, attention has to be paid to the patients' point of view and expectations.


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"Cats" Can't Clinch Region Reign: But Bobcats Bound for State Host First First Round GameSports February 21, 2014
The Gilmer High School Bobcats basketball team had one of its most successful seasons ever, and Gilmer was looking to add that elusive Region Championship to the accomplishments this team had achieved this year. While the "Cats" did not clinch the crown, Gilmer's second place finish garnered a first ever home State playoff game in Gilmer.The bracket was set up perfectly for the Bobcats to have a third chance at River Ridge, a team the "Cats" had fallen to twice on the year. In Gilmer's way though were two other matches, one against LaFayette and the other against the tournament host Cass Colonels.
After inclement weather had pushed the game back a few days, the matchup between Gilmer and LaFayette was finally underway. The Bobcats was firing on all cylinders in this one, especially in the opening quarter, has Gilmer dropped 24 points.
Taner Reece got things started with an offensive rebound put-back, something Gilmer's grown accustomed to seeing. Another common sight was the back to back three-pointers by Wheeler Lancey and Joe Bob Charles. The three went off in the quarter while the team also provided stellar defense. This gave the Bobcats a 24-9 lead after one.
The second quarter saw a new group of Bobcats get on the board. Corey Waters knocked down a three to begin the period and Hayden Hoequest followed that up with another quick basket. A Hoequest block then led to Chandler Burrell's first basket of the game. Burrell would add another along with Kyle Hedden getting in on the action. At halftime, the Bobcats held a commanding 41-23 lead.
The lead only grew in the third quarter, with the usual suspects pouring in more shots. Charles, Lancey, Waters, and Reece all scored in the third quarter as the Bobcats only gave up six points. With a quarter left to play, GHS led 62-40.
Other than a couple of baskets, the fourth quarter mainly consisted of free throws for the Bobcats who were continuously being fouled. The big shot of the fourth quarter came when Preston Kingsley entered the game and nailed a three-pointer in the closing moments of the game, sealing an 83-56 victory for the Bobcats.
The next team standing in the way was the Colonels of Cass. Just like the first game, Reece started the scoring by grabbing an offensive rebound and scoring. Despite two baskets by Waters, GHS fell behind 11-6. A three-pointer by Lancey got it close, but Cass scored four straight points to close the quarter with the lead, 15-9.
Charles got things going early in the second with a catch and shoot three-pointer. Two Bobcat steals turned into points from Reece and Charles, then Lancey drilled his second three of the game. Just like that, Gilmer had started the quarter on a 10-0 run. After a timeout Cass was able to tie it back up at 19-19, but Gilmer closed the quarter with six straight points. The Bobcats outscored the Colonels 16-4 in the second quarter and took a 25-19 lead into the locker room at the half.
The third quarter was an uncharacteristic one for Gilmer as the "Cats" came out and only scored four points. Cass didn't take advantage of it, as the Colonels could only score enough to get a 30-29 lead with just a quarter to go.
A Lancey three-pointer to start the final quarter helped ignite the offense as Gilmer went on to score fifteen points in the fourth and beat the Colonels 44-38 behind a big quarter from Charles. This win set up a championship match against the River Ridge basketball team.
It was the moment Gilmer fans had all waited for all year. This amazing Gilmer Bobcat basketball team had found its way into the Region Championship game. The Bobcats came out on fire, knocking down their shots and handling the athletic Knights team.
Reece, Waters, and Charles all scored in the opening period and although Gilmer only held a 16-13 lead, the momentum was shifted more towards the Bobcats.
The second quarter was a bit sloppy for Gilmer. Turnovers hurt the "Cats" badly as well as foul trouble. GHS was only able to score six points allowing River Ridge to take a 29-22 lead at the half.
Things only got worse in the second half for Gilmer. Some of Gilmer's wounds were self-inflicted; however, the Knights had a great night. The River Ridge shots were falling and Gilmer's weren't, and that is really what it came down to.
The Knights kept pulling away and ended up cruising to a 67-40 win. It's not all bad for the Bobcats though, as the "Cats" locked up a home game in the State Playoffs this Saturday at 4:00 against Fayette County.


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...or at least their marketing teams want you to think so. Purchased yesterday: Citizens for Humanity and 7 for All Mankind. Hmm, benevolent.
And if that is the case, then my new sweats are street-walkers: Juicy (Yes, Denise, I just did something I said I would never do, but they are intended for airline travel only and they don't match! And they were totally over-priced!).
The only way for me to rationalize those jeans brand names is to assume that they are meant for Generation Y (those crazy, energetic do-gooders) and I should just be happy that they fit.


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Topo of Frigid Air Buttress
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The only guidebook topos to this route are very vague, so I thought I'd improve upon them some, for what is a really excellent trad multi-pitch adventure. Topo based on an ascent by Brutus and Nurse Ratchet. Comments and corrections appreciated.
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Frigid Air Buttress, 5.9+, 10 Pitches (Route)
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Branislav Ivanovic faces a violent conduct charge after footage emerged of an off-the-ball clash with Wigan's Shaun Maloney on Saturday and could be banned Chelsea's FA Cup semi-final against Tottenham.
• Chelsea 2-1 Wigan: Latics lose at death
• Blunder official pays price
The FA are aware of a video which appears to show Ivanovic punching Latics midfielder Maloney in the midriff moments before Juan Mata's controversial winner in the Blues' 2-1 Premier League victory at Stamford Bridge.
The FA will ask referee Mike Jones to confirm he and his assistants did not witness the incident and then review the footage - which shows Maloney going down bent double following the clash - before deciding whether to charge Ivanovic.
The Serbian, who opened the scoring on Saturday, could face a three-match ban if found guilty of violent conduct.
The matter will not be dealt with before Chelsea's game at Fulham on Monday night, meaning any suspension would see Ivanovic miss Sunday's FA Cup semi-final against Tottenham and other crucial derby fixtures against Arsenal and QPR.
Any punishment for Ivanovic would only add insult to injury for Wigan boss Roberto Martinez after the officials failed to chalk off both Chelsea goals for offside on Saturday.
Martinez is still waiting to hear whether he will face an FA charge of his own after branding assistant referee Dave Bryans' performance "disgusting'' and "horrific'', as well as questioning the treatment of his side in other matches this season.


text:
Not a suggestion boxEdit
Removed the bit that said implementing one-handed polearms etc. would be a good idea as Wowwiki was, last I checked, not a suggestion box Razzik (talk) 07:20, 18 May 2008 (UTC)
Update article? Edit
I noticed some of the Polearms were not as notable as they used to be. This article needs to be updated.


text:
Like almost every media outlet today, public radio station WNYC is facing tough times — as we reported yesterday it is now cutting 4 employees and eliminating eleven other unfilled positions. So it is with high hopes that the WNYC board has elected Herb Scannell chair of the station's board of trustees.
Scannell seems like a wise choice to help lead WNYC into the future of media; he is currently chairman of Next New Networks, an independent producer of online television networks. (You may know it as the home of web celeb Julia Allison's "TMI Weekly" or the company that picked up Obama Girl creators BarelyPolitical.com.) He also previously served as vice chair of MTV Networks and president of Nickelodeon before co-founding Next New Networks in 2006, and he brings 25 years of media experience to his role at WNYC.
"As the models of traditional journalism are radically altered by the economy and the fast-paced demands of the online world, public radio has been able to retain its journalistic values while embracing new platforms and expanding its reach," NYC president Laura Walker said in a statement yesterday. "We're honored to have Herb, with his invaluable digital experience, at the helm during a time of rapid change and tremendous possibilities."
Full release after the jump
Herb Scannell Elected to Chair of WNYC Board of Trustees
(June 3, 2009 — New York, NY) – Herb Scannell has been elected to Chair of the WNYC Radio Board of Trustees. WNYC is the nation's most listened-to public radio station, with a radio listenership of over one million.
Mr. Scannell, Chair of Next New Networks and former Vice Chair of MTV Networks, brings over 25 years of media programming, distribution and business management experience to his new role.
"We are excited to have Herb assume the role as Chair of the Board of Trustees," said WNYC President Laura Walker. "Herb has been a major innovator in new and traditional media for over two decades, leading Nickelodeon to become cable's top-rated network for a decade, and most recently co-founding Next New Networks, a leading independent in internet television/video. As the models of traditional journalism are radically altered by the economy and the fast-paced demands of the online world, public radio has been able to retain its journalistic values while embracing new platforms and expanding its reach. We're honored to have Herb, with his invaluable digital experience, at the helm during a time of rapid change and tremendous possibilities."
"I'm thrilled to be a part of WNYC at this critical time in the station's – and the industry's — evolution," said Herb Scannell. "Unknown to many, my first job in media was in radio, and I've always been passionate about the immediacy and intimacy of the medium. WNYC means a lot to me as a New Yorker and an avid listener, and it is one of the most innovative producers in the industry. The station has taken its place as the convener of the New York conversation, and the street-level Jerome L. Greene Performance Space is opening up new ways to engage people in that conversation. I'm thrilled to serve in this role as WNYC addresses the next set of challenges and goals for itself, especially as we aim to build a both a larger and broader listener base and increase capacity online."
Herb Scannell is co-founder Next New Networks, a company launched in Fall 2006 that produces, packages and distributes micro-television networks targeting niche communities on the Internet. Currently Chairman, he began as CEO and pioneered a strategy of super distribution, distributing Next New Networks programs to over 20 partners, including YouTube, AOL, and iTunes. Mr. Scannell guided the company through two rounds of funding, raising $23 million from blue chip companies including Spark Capital, Saban Media, Goldman Sachs and Velocity Interactive Group. Next New Networks garnered over 300 million video views last year and has been cited for its innovative brand integrated advertising.
Prior, Mr. Scannell was Vice Chairman of MTV Networks and President Nickelodeon Networks. There, he oversaw all creative and business operations for a portfolio of brands and businesses for MTV Networks, including Nickolodeon, the #1 rated cable TV network; TV Land, the cable channel devoted to classic TV shows; and Spike TV, cable's first network for men. Additionally, he built Nickelodeon into the third largest licensing business in the world, catapulted it into the digital era with the launch of TurboNick and the acquisition of Neopets, and brought Nickelodeon into the movie-making business, making it one of Paramount Pictures most profitable producers.
Mr. Scannell first joined MTV Networks as Director of Programming, Nickelodeon in 1988. He was instrumental in transforming Nickelodeon into a major content producer with the birth of Nicktoons (Rugrats, Ren & Stimpy, and Doug) and innovative live action shows. He set a course that doubled the network's animation output and built the first new animation studio in Los Angeles in 40 years, bringing top hits including Spongebob Squarepants, Hey Arnold, Fairly Odd Parents, Blues Clues and Dora The Explorer into fruition.
Earlier, Mr. Scannell held marketing and promotional positions at The Movie Channel and Showtime, and he started his career in radio at WHN Radio in New York.
In addition to WNYC, Mr. Scannell serves on the Boards of Ballet Hispanico, a leading Hispanic dance and cultural institution in New York, and Si TV, the first English-language Latino entertainment and lifestyle network on cable TV.
Mr. Scannell is a graduate of Boston College, and lives with his family in New York City.


text:
By Evan Mohl
The Cove Herald
Never in his wildest dreams did Michael Loyd believe he'd be a world champion.
But last week, the Copperas Cove resident won the Electronic Arts (EA) Champions of Gaming contest for NASCAR 09 in Orlando, Fla. For his prize, Loyd received five Xbox 360 games, a free year's subscription to Xbox LIVE, a plaque and a chance to race against NASCAR driver Denny Hamlin in a one-on-one battle.
A recap of the entire event, which also included competitions in NBA Live 09, Tiger Woods PGA TOUR Golf 09, EA SPORTS Soccer 09 and Madden NFL 09 will be aired Feb. 18 on Spike TV at 10:30 p.m.
"I guess I got my 15 minutes of fame," Loyd said. "The whole experience was great. A lot of fun and just exciting."
Loyd barely defeated Hamlin in a six-match lap. The 25-year old started out in the lead before Hamlin overtook him. After the two players exchanged leads again, Loyd took over on the last lap to edge out the NASCAR driver.
Hamlin then signed a copy of the game for Loyd, who blamed the close race on the fact he had to use default settings as opposed to his own car.
"The key to the game is how you build your car in garage, just like real life," Loyd said. "But it was fun to race Denny in a close one. We got to talk a little bit, comparing the game to real life. He said it was pretty close, especially all the things you can do to tweak your car in the garage."
Loyd believes his skill in the garage - the actual building of the car - is what got him the world champion crown. He estimates that he spends more time working on his car than on the track.
Balance is the most important ingredient, according to Loyd.
"A lot of people make their cars really fast, but then they wreck on a turn," he said. "Other people have really good handling, but can't go fast enough. I try find a happy medium."
Loyd never played the video game in the hopes of becoming a world champion. He actually stumbled across the concept while playing online with his friend.
After signing on Xbox LIVE to, an advertisement for a tournament of the Americas peaked Loyd's interest. He checked the link out, and decided to see where he stacked up against some of the best players in the world.
"It's kind of funny because I usually just play private games with my friend," Loyd said. "I don't like to race newbs."
The tournament lasted 10 weeks. To advance, a player had to be in the top 10 in points. Loyd easily qualified.
After the top 100 players were set, Loyd had to get through the knockout round. It lasted one week, and the the player with the most points moved on to the global challenge.
Loyd didn't race nearly as much as some, but still managed to win. He competed 80 times, winning 13 and getting second more than he could count.
With no qualifiers from the other regions - Europe and Asia - Loyd was crowned world champ.
"I was just lucky I guess," Loyd said. "It all just kind of worked out."
Organizers of the event disagreed.
"These newly crowned Gillette-EA SPORTS Champions of Gaming have proven that they have what it takes to compete at the highest level, just like our Gillette Champions," said Peter Clay, Vice President, Gillette Global Grooming. "Through our partnership with EA SPORTS, we're proud to provide our winners with the experience of a lifetime and the chance to compete against some of the top names in sport."
Loyd, originally from Kingstree, South Carolina, moved to Cove about two years ago to help take care of his deployed brother's place. He watches pets and takes care of the house, among other thigns.
Since then, he's been doing the same deed for other service families throughout the area.
"It's kind of strange, I never thought of myself as a Texan," Loyd said. "But they introduced me from Texas at the event and I have embraced it a little bit. I really like living in Cove a lot."
Loyd estimates that he plays NASCAR 09 about one to four hours a day, on average. Sometimes he'll go more, sometimes he won't even play.
He bases his style on Jeff Burton, his favorite driver.
"I think he's one of the most respected drivers out there," Loyd said. "He's just always consistent, kind of like I try to be."
Unlike Burton, however, Loyd has a title.


text:
Patent application title: Tissue Repair Device And Apparatus And Method For Fabricating Same
Thomas W. Sander (Winona Lake, IN, US)
Daniel R. Lee (Madison, CT, US)
Wayne C. Person (Newtown, CT, US)
Steven Howansky (Wilton, CT, US)
IPC8 Class: AA61F208FI
USPC Class:
623 1314
Class name: Implantable prosthesis ligament or tendon including ligament anchor means
Publication date: 2010-01-21
Patent application number: 20100016966
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Patent application title: Tissue Repair Device And Apparatus And Method For Fabricating Same
Thomas W. Sander
Daniel R. Lee
Wayne C. Person
Steven Howansky
Tyco Healthcare Group LP
Origin: NORTH HAVEN, CT US
IPC8 Class: AA61F208FI
USPC Class:
623 1314
Patent application number: 20100016966
A method for fabricating a device for repairing torn tissue or muscle such
as the meniscus of the knee. The device includes a pair of anchoring
members having a plurality of barb-like projections extending outwardly
therefrom. The anchoring members are joined by a flexible linking member
which connects the ends of the anchoring members opposite one another.
Such a device can be fabricated by insert molding of the appropriate
members together.
1-9. (canceled)
10. A repair device for repairing a torn meniscus in a knee joint, comprising:a pair of needlesa pair of anchoring members, each of the pair of anchoring member being secured to one of the pair of needles;a flexible material interconnecting the pair of anchoring members;a retaining flange on each of the pair of anchoring members.
11. The repair device according to claim 10, wherein the needles are secured to the anchoring members by a detachable joint.
12. The repair device according to claim 10, wherein each of the pair of anchoring members has a plurality of barbs.
13. The repair device according to claim 12, wherein the barbs are oriented to allow the anchoring members to pass through tissue in a first forward direction, but grip tissue in a second reverse direction.
14. The repair device according to claim 10, wherein each of the pair of needles are curved.
15. The repair device according to claim 10, wherein the flexible material includes filaments.
16. The repair device according to claim 10, wherein the flexible material includes a polymeric material.
17. The repair device according to claim 16, wherein the flexible material includes a bio-absorbable polymer.
18. The repair device according to claim 10, wherein the needles are formed from a metallic material.
19. The repair device according to claim 10, wherein the needles and anchoring members are fused to one another.
20. The repair device according to claim 10, wherein the retaining flanges are separate members that are slipped over the needles onto the anchoring members.
[0001]This application is a continuation of U.S. patent application Ser. No. 08/369,858 filed on Jan. 6, 1995, which is a continuation of U.S. patent application Ser. No. 08/144,453 filed on Oct. 27, 1993, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 07/699,991 filed May 13, 1991, now U.S. Pat. No. 5,269,783 all of which are incorporated herein in its entirety by reference.
[0002]1. Field of the Invention
[0003]The present invention relates to a device for repairing torn tissue and muscle in the body, and more particularly to a device for repairing a torn meniscus in the human knee. A method of repairing torn meniscal tissue is also disclosed. The present invention is also directed to apparatus and method for fabricating the invention device.
[0004]2. Discussion of the Prior Art
[0005]The surgical repair of torn tissue and muscles in the body has typically been performed through incisions in the body to expose the area under repair and the actual procedure includes the provision of sutures, staples or fasteners. The advent of arthroscopic techniques and endoscopic equipment have reduced the size and depth of the incision required to perform the repair procedure. However, the use of conventional devices in many cases requires a highly skilled surgeon to perform the repair, and usually requires complete immobilization of the surgical area following the repair procedure.
[0006]Surgical repair of cartilage and muscle in joints such as the knee often requires extraordinary skill on the part of the surgeon to reduce damage to adjacent nerves, blood vessels, muscles and tendons in the knee joint. In particular, surgical repair of the fibrocartilage disks within the knee known as the menisci, which are attached peripherally to the joint capsule, requires precision to avoid such damage.
[0007]In the past, meniscal surgery has included procedures for partial to complete removal of a torn meniscus, as well as attempts to surgically suture, staple or tack the tear in the meniscus to allow for healing. Other techniques have included removal of portions of the meniscus to arrest the spread of the tear.
[0008]A technique has been developed using arthroscopic instruments which provides for meniscal repair through the use of a pair of surgical needles which are inserted through cannuli into the knee on opposite sides of the tear in the meniscus to be repaired. The needles are linked by a single suture which is pushed down through the cannuli and across the tear. An incision is made in the skin at the point where the needles exit the knee joint so that the leading end of each needle may be grasped and pulled through the joint. The ends of the sutures are then grasped after the needles are removed from the suture ends and the suture is then tied outside the skin so that a horizontal suture is created in the meniscus. This procedure is repeated for placement of as many sutures as necessary to repair the meniscus tear. This process is very time consuming, and the strength of the repair is dependent upon the tension created by the knot tied in the suture.
[0009]The need exists for a device for repairing torn tissue, such as the meniscus of the knee, which obviates the disadvantages encountered in the prior art and provides an efficient, suture-type device which expedites the surgical procedure and reduces the amount of precision necessary on the part of the surgeon during the procedure. Additionally, there is a need for providing smooth, reliable fabrication of a suture-type device for repairing torn tissue such as the knee meniscus, especially for fabricating such a device out of material having dissimilar flexibilities.
[0010]In this regard, two general processing techniques have been previously utilized for attaching a fiber or filamentous structure such as a braid to a solid object. The first such general process involved the mechanical crimping or tying of the braid to a solid piece. The second technique involved welding the braid to the solid piece by using energy such as heat, ultrasound, etc. or chemicals such as solvent, glue or adhesive, etc. However, these prior techniques are either extremely cumbersome or fail to form reliable, secure attachment between materials of dissimilar flexibilities. Accordingly, the need exists for smooth, reliable fabrication of such tissue repair devices, notably surgical implants prepared from resorbable materials such as surgical clips or staples.
[0011]The present invention provides a novel device for repairing torn tissue and muscle such as the menisci in the knee joint which expedites the surgical process and facilitates complete healing of the tear. The device of the present invention reduces the precision required on the part of the surgeon to accurately place and secure the suture at the tear site, and expedites the surgical process by eliminating the requirement of securing the ends of the sutures together to stitch the tear. The device of the present invention allows a surgeon to reduce the trauma to the surrounding tissue and facilitates healing of the torn muscle tissue by providing a completely resorbable suture-like device which may remain in place until the tear is completely healed.
[0012]The device for repairing torn tissue and muscles of the present invention comprises a pair of surgical needles each secured at one end to a pair of surgical needles each secured at one end to a pair of anchoring members which essentially comprise absorbable rods having outwardly projecting barbs. Each anchoring member is secured at a second end to an absorbable flexible material such as a suture which extends between the two anchoring members. The means of securement between the needles and anchoring members, and between the anchoring members and the suture may include adhesives, swaging, crimping or a quick-release connection such as heat-shrinkable tubing. Preferably, the suture and the anchoring members are constructed of a bioresorbable material.
[0013]The barbs of the anchoring member have a tapered configuration towards the needles so that as the needles are pushed through the tissue, the barbs easily pass through the tissue with the needle. The configuration of the barbs is such that the anchoring members pass easily through the tissue in the forward direction, but are prevented from moving in the reverse direction. The barbs are provided to anchor the device in the tissue.
[0014]The needles of the present invention may be straight needles, preferably constructed of stainless steel or other surgical grade metal alloy. Although preferably straight, it is contemplated that the needles may be curved, similar to suture-type needles.
[0015]In use, the damaged or torn meniscus in the knee is arthroscopically approached from the front of the knee by inserting the needles across the tear and then advancing the needles through the meniscus across the tear, drawing the absorbable anchoring means through the meniscus and then through the joint capsule to exit through a previously made incision. The suture is then pulled substantially flush with the meniscus across the tear, whereby the surgeon may the pull the needles through the incision, which had been made to expose the outer surface of the joint capsule. The needles are then cut, or may be detached by a sharp pull when the suture contacts the meniscus across the tear. The barbed anchoring means are then cut substantially flush with the joint capsule on the side opposite the suture, the incision is closed; and the anchoring means holds the suture in place. The barbs on the anchoring means serve to maintain the position of the device within the meniscus, and the suture and anchoring means serve to maintain the tear at close approximation to enhance healing. The material compositions of the suture and the anchoring means are selected to provide the desired resorption rate to allow sufficient time for healing.
[0016]In the event that the tissue being repaired is not sufficiently strong to retain the barb members in place, a retaining flange may be utilized which is slipped over the barbs after it is drawn through the tissue to apply counter pressure against the surface of the joint capsule to pull the suture tight across the tear.
[0017]The present invention is also directed to apparatus and method for fabricating the repair device supra which are effective for joining elements formed of materials having dissimilar flexibilities to provide a device that will effectively function when used to repair torn tissue. In particular, the invention apparatus and method can be used to fabricate a series of tissue repair devices at one time.
[0018]In the fabrication of a composite device of materials having dissimilar flexibilities in accordance with the invention, one of the pieces of material, e.g., the material of greater flexibility, is first placed in a mold such as a compression or injection mold. The material of different flexibility, e.g., polymeric material of less flexibility, is then injection or compression molded about the material previously placed in the mold cavity. When forming a meniscal staple, a segment of braided suture material which can be resorbable is placed within a channel or groove of the mold that interconnects cavities for molding the substantially rigid tips. Into each rigid tip cavity, a portion of the length of braided suture material is centrally located within the respective cavities. The mold halves are then closed and the molding polymer is introduced into the cavities, e.g., by injection. The molten or flowable polymer then surrounds and encapsulates the braided suture material extending into the rigid tip cavities. Upon cooling of the molten material, a composite meniscal staple device is formed from materials having dissimilar flexibilities where the braided suture is firmly attached to the molded rigid tips of the staple.
[0019]The present invention provides for facilitated attaching of a flexible member, e.g., a braided suture, to a rigid part, notably where both flexible and rigid members are fabricated from resorbable material as in the case of forming surgical implants. A composite member which can be used as a tissue repair device is thereby fabricated and possesses secure attachment between materials of dissimilar flexibilities, e.g., a uniquely shaped, rigid, hard solid component reliably coupled to a flexible yet tensilely strong fibrous or filamentous structure.
[0020]The foregoing features of the present invention will become more readily apparent and may be understood by referring to the following detailed description of illustrative embodiments of the device for repairing torn tissue and muscle and apparatus and method for fabricating the same taken in conjunction with the accompanying drawings, in which:
[0021]FIG. 1 illustrates a perspective view of the device of the present invention;
[0022]FIG. 2 illustrates a perspective view of an alternate embodiment of the device of the present invention;
[0023]FIG. 3 illustrates a perspective posterior view of the muscular structure of the knee;
[0024]FIG. 4 illustrates a cut-away perspective view of the knee of FIG. 3 along line 4-4 showing the device of the present invention in position during the meniscal repair procedure;
[0025]FIG. 5 illustrates a perspective anterior view of the knee of FIG. 3 with the device of the present invention in position during the meniscal repair procedure;
[0026]FIG. 6 illustrates a perspective view of an alternate embodiment of the device of FIG. 1;
[0027]FIG. 7 illustrates a perspective view of a further alternate embodiment of the device of FIG. 1;
[0028]FIG. 8 is a top plan view of a portion of apparatus for fabricating the device of the present invention;
[0029]FIGS. 9 and 10 are a schematic perspective views of the apparatus portion shown in FIG. 8 illustrating steps in the fabrication of the invention device;
[0030]FIG. 11 is a side view of the device fabricated with the apparatus of FIGS. 8-10;
[0031]FIG. 12 is a broken top view of an alternative embodiment of apparatus used to fabricate the invention device;
[0032]FIG. 13 is a broken side view of the invention device fabricated with the apparatus illustrated in FIG. 12;
[0033]FIG. 14 is a top plan view of an alternative embodiment of a tissue repair device fabricated in accordance with the present invention.
[0034]FIG. 15 is a top view of an alternative embodiment of apparatus used to fabricate the invention device; and
[0035]FIG. 16 is a side view of a portion of the apparatus of FIG. 16 and its countermold in the direction of arrows A-A in FIG. 15.
[0036]Referring now in specific detail to the drawings, in which like reference numerals identify similar or identical elements throughout the several views, FIG. 1 shows the repair device 10 of the present invention. Repair device 10 generally comprises a pair of metal needles 12, preferably constructed of stainless steel or other surgical metal alloy, having a sharp tip 13 at one end to facilitate penetration through tissue, and a blunt end at the other end. In a preferred embodiment, the length of each needle is between 6 inches and 10 inches. However, this is not intended to be limiting as clearly needles of various lengths may be utilized.
[0037]Secured to needles 12 are a pair of anchoring members 14 which are constructed of a bioresorbable material, such as homopolymers and copolymers of lactide, glycolide, polydioxanone, trimethylene carbonate, polyethylene oxide or other bioabsorbable materials or blends of these copolymers. Preferably, the anchoring members 14 are formed of a copolymer of lactide and glycolide. Anchoring members 14 are linked by a flexible material 16 such as a suture, also constructed of a bioresorbable material, such as a lactide/glycolide copolymer. Flexible material 16 allows for movement of anchoring members 14 with respect to one another. Anchoring members 14 preferably have a length of between about 0.040 inch and 2 inches, more preferably between about 0.050 inch and one inch.
[0038]Needles 12 are secured to anchoring members 14 as indicated at joint 20, and the anchor members 14 are secured to suture 16 as at joint 22. The anchoring members 14 of device 10 may be secured to the needles 12 by means of adhesives, crimping, swaging or the like, and joint 20 may be formed by heat-shrinkable tubing. It is preferred that joint 20 is a detachable connection, such that needle 12 may be removed from anchoring member 14 by a sharp tug or pull or by cutting as described below. Anchoring members 14 are secured to suture 16 preferably by insert molding.
[0039]Anchoring members 14 are provided with a plurality of barb-like projections 18 which serve to anchor device 10 in the tissue to be repaired. Barbs 18 have a tapered shape to allow the anchoring members 14 to be pushed through tissue or muscle, such as the menisci of the knee, in a first forward direction and to prevent the anchor members from traveling in a reverse direction. Although as shown in FIG. 1 five barbs 18 are provided, any number may be provided, so long as the barbs penetrate the tissue to anchor the device 10.
[0040]FIG. 2 illustrates an alternate embodiment of the device of the FIG. 1. Device 30 is similar in construction to device 10 except that curved needles 32 are provided. Needles 32 are secured to anchoring members 14 as described above, which are provided with a plurality of barbs 18 which taper in the direction of needles 32 to facilitate insertion of the device into tissue. Anchoring members 14 are connected through suture 16 as described above. The remaining elements of device 30 are identical to those of device 10 as illustrated in FIG. 1.
[0041]FIG. 3 illustrates the muscular and ligament structure of the knee 34, including the pertinent components of the knee to which the present invention is directed. As is well known, the femur 35 is joined to tibia 36 and fibula 37 by muscles, tendons and ligaments, and these bones are separated and cushioned by the medial meniscus 44 and lateral meniscus 45. Condyles 38 of femur 35 rest on the menisci, and the bones are joined and supported by anterior cruciate ligament 39, ligament of Wrisberg 40, posterior cruciate ligament 41, and transverse ligament 46 (see FIG. 5). The joint capsule is formed by tibial collateral ligament 42 and fibular collateral ligament 43.
[0042]FIG. 4 illustrates the device 10 of the present invention in use, showing knee 34 along lines 4-4 of FIG. 3. The lateral meniscus 45 of a knee 34 having a tear 52 is repaired with the present invention by forcing needles 12 through the meniscus on one side of the tear, through the torn region, and out the meniscus tissue on the opposite side of the tear on the outside of the knee. The device is fully inserted so that flexible member 16 becomes substantially flush with meniscus 45 and is pulled taut. Barbs 18 of anchoring members 14 anchor the device in the meniscus 45 and prevent the device from backing off, so that tear 52 is maintained in an abutting relationship across itself to facilitate healing. Needles 12 may then be removed from anchoring members 14 by means of a sharp yank or tug, or are cut as they are accessed from the opposite side of the knee by a suitable incision. Anchoring members 14 are then trimmed so as to be flush with the surface of meniscus 45 or the joint capsule. The material of which anchoring members 14 and suture 16 are constructed are preferably bio-resorbable materials which resorb at a rate which is slow enough to facilitate healing of the tear in the tissue.
[0043]During arthroscopic surgery, as best seen in FIG. 5, the surgeon will approach the torn meniscus from in front of the knee and insert the two needles 12 into the meniscus 44 or 45. As the needles 12 are pushed through the meniscus 45 to draw the edges of the tear together, the surgeon will make an incision on the opposite side of the knee adjacent the needles to avoid pushing the needles through the skin. As the needles are withdrawn, the suture 16 is pulled tight to hold the edges of the tear together while the barbs 18 prevent the backing off of the device 10 through the tissue. The needles are then removed and the anchor members are trimmed to the surface level of the joint capsule and the incisions are stitched.
[0044]Turning now to FIG. 6, there is shown a further embodiment of the device of the present invention. Device 60 is identical to device 10 except for the provision of retaining flanges 62 which slip over needles 12 and anchoring members 14 to apply counter pressure against the surface of the joint capsule to pull the suture 16 tight across the tear in the meniscus. Flanges 62 are utilized when the strength of the tissue through which the device passes is insufficient to hold barbs 18 in place.
[0045]FIG. 7 illustrates a further embodiment of the device of the present invention. Device 70 is identical to device 10 except that barbs 18 are aligned with each other, rather than staggered as in accordance with FIG. 1. Clearly, device 70 may include curved needles as shown in FIG. 2 or retaining flanges 62 as shown in FIG. 6.
[0046]As noted supra, anchoring members 14 are preferably secured to suture 16 by insert molding. The techniques of compression and injection molding are per se well-known. For example, injection molding is described, e.g., by Paul N. Richardson, "Plastics Processing", Encyclopedia of Chemical Technology, Volume 18 (Third Edition), John Wiley & Sons, pp. 195-199; Irvin N. Rubin, "Injection Molding", Encyclopedia of Polymer Science and Engineering, Volume 8 (Second Edition) John Wiley & Sons, pp. 102-138; and A. B. Glanvill, "Injection Moulding", Thermoplastics: Effects of Processing, London Iliffe Books Ltd., 1969, pp. 110-182. More specifically, the injection molding process involves heating thermoplastic material so that such material is rendered in flowable condition. After the thermoplastic material has been rendered sufficiently molten, the material is then injected into the mold cavity defined between the mold and counter mold portions, e.g., by a piston head or extruder screw. Compression molding is described, e.g., by Herbert Rees, "Mold", Encyclopedia of Polymer Science and Engineering, Supplemental Volume (Second Edition), John Wiley & Sons, pp. 507-509, which also describes injection molding and a combination of injection-compression molding.
[0047]Using the technique of compression molding, the material retaining its initial form, e.g., a flexible braided suture, is first placed in an open mold, followed by introduction of an excess of molten thermoplastic material. The mold is then closed with the mold halves compressed together to shape the molten material as it hardens and forms rigid members attached to, e.g., the flexible braid. In this respect, using an excess of thermoplastic material together with proper application of heat and pressure in a compression mold allows the material to flow within the mold cavity and then solidify to form rigid members of proper dimensions. A heating/cooling pipe and/or other heating/cooling sources can be provided within the mold portions to control heat application and prevent damage or changes to the braid structure.
[0048]In this regard, compression or injection molding apparatus is provided as part of the present invention for joining the suture 16 and anchoring members 14. An embodiment of such apparatus is illustrated in FIGS. 8-10. More particularly, FIG. 8 illustrates a mold portion 80 forming part of the injection molding apparatus, this mold portion 80 comprises various tracks or recesses 81-85 and projecting pegs 86 and 87. A countermold portion 80' (FIG. 10) is formed as an exact mirror image to mold portion 80, the only difference being that recesses 86', 87' are provided in the countermold portion 80' at the location corresponding to projecting pegs 86 and 87 in mold portion 80. Projecting pegs 86 and 87 are in the countermold portion 80 when the mold portion 80 and countermold portion 80' are secured together, thereby defining internal channels or cavities along recesses 81-85 which are entirely enclosed except for the open end 88 of recess 81. Additional pegs and corresponding recesses can be provided upon mold portion 80 and the countermold portion 80' for securing these portions 80, 80' together to form an endorsed cavity. The recesses 81-85 of the mold portion 80 and recesses in the countermold portion 80' can be substantially symmetrical, however they need not necessarily be symmetrical as long as the properly shaped internal cavity is defined for injection molding the tissue repair device when the mold 80 and countermold 80' portions are brought together.
[0049]Tracks or recesses 84 and 85 in mold portion 80 (and the corresponding tracks or recesses in countermold portion 80' are each shaped to define anchoring members 14 with barbs 18 thereon. In this regard, recess 89 interconnecting recesses 84 and 85 is positioned in mold portion 80 as shown in FIG. 8 to receive flexible material 16 for linking anchoring members 14 together. Flexible material 16 is retained in place in mold portion 80 between projecting pegs 86 and 87 and shown in FIG. 9. Tracks or recesses 81, 82 and 83 serve as inlet channels for injection of fluid material under pressure into recesses 84 and 85 when the mold portion 80 and countermold portion 80' are closed.
[0050]The insert molding process of the present invention can be utilized to prepare the tissue repair devices illustrated in FIGS. 1-3, 4 and 7 of the present application and also the surgical clip device of U.S. Pat. No. 5,002,562 issued Mar. 26, 1991, the contents of which are incorporated by reference herein. In this regard, anchoring members 14 are formed of moldable material that can be subjected to injection molding, i.e., thermoplastic material which is rendered flowable upon requisite application of heat and/or pressure so that such material will flow into and fill the mold cavity taking the shape thereof, and then solidify upon cooling. Any of the suitable bioresorbable materials enumerated supra are capable to being injection molded into the requisite anchoring members 14. However, there is no requirement that the material used to form anchoring members 14 must be bioresorbable as long as such material is biocompatible and capable of being molded.
[0051]The bioabsorbable polymers which can be compression and/or injection molded include those derived from polyglycolic acid, glycolide, lactic acid, lactide, dioxanone, e-caprolactone, trimethylene carbonate, polyethylene oxide, etc., and various combinations of these and related monomers. Polymers of this type are known in the art, principally as materials for the fabrication of such surgical devices as sutures, wound clips, and the like, as disclosed, e.g., in U.S. Pat. Nos. 2,668,162; 2,703,316; 2,758,987; 3,225,766; 3,297,033; 3,422,181; 3,531,561; 3,565,077; 3,565,869; 3,620,218; 3,626,948; 3,636,956; 3,736,646; 3,772,420; 3,773,919; 3,792,010; 3,797,499; 3,839,297; 3,867,190; 3,878,284; 3,982,543; 4,047,533; 4,060,089; 4,137,921; 4,157,437; 4,234,775; 4,237,920; 4,300,565; and 4,523,591; U.K. Patent No. 779,291; D. K. Gliding et al., "Biodegradable polymers for use in surgery--polyglycolic/poly(lactic acid) homo- and co-polymers: 1", Polymer, Volume 20, pages 1459-1464 (1979), and D. F. Williams (ed.), Biocompatibility of Clinical Implant Materials, Vol. II, ch. 9: "Biodegradable Polymers" (1981). Copolymers of glycolide and lactide with or without additional monomers are preferred and of these glycolide-lactide copolymers are most preferred, for example a mixture of 80% by weight a 25/75 mole ratio Glycolide/Lactide copolymer blended with 20% by weight glycolide.
[0052]Material forming linking member 16 coupling the anchoring members 14 has flexibility greater than the material forming anchoring members 14. In this regard, the linking member 16 can be fabricated from the same bioresorbable materials supra and/or nonresorbable materials infra for fabricating the anchoring members 14. Flexibility is imparted to linking member 16 by providing the linking member 16 in fiber or filamentous form such as a suture. As used herein the term "fiber" or "filamentous" refers to materials which may be characterized as having a denier (see, e.g., Plastics Terms Glossary, Fourth Edition, Phillips Chemical Company, Bartlesville, Okla.).
[0053]Fiber-forming materials which are relatively inelastic are suitable for providing the linking member 16 provided such materials are more flexible than the anchoring members 14 and fairly rapidly bioabsorbed by the body, e.g., exhibiting a loss of tensile strength in from about 2 to about 26 weeks and total absorption within from about two to about fifty two weeks. It is to be understood, however, that the expression "relatively inelastic" does not preclude the presence of some minor degree of elasticity.
[0054]The linking member 16 can be composed of fibers or filaments of bioresorbable or nonresorbable material or from a blend of filaments possessing different bioabsorbabilities and elasticities to create a member 16 that is semi-absorbable. For example, linking member 16 can be fabricated from the composite yarn described in U.S. Pat. No. 4,990,158 issued Feb. 5, 1991 and the connective tissue prosthesis described in U.S. Pat. No. 5,147,400 issued Sep. 15, 1992, the contents of these United States patents being incorporated by reference herein.
[0055]The present invention may also be practiced with non-bioabsorbable absorbable polymeric materials having thermoplastic properties such as nylon, polyester, polypropylene, polytetrafluoroethylene (PTFE), polyethylene terephthalate (Dacron), etc. Non-absorbable materials which are especially suitable for fabricating the anchoring member or linking member of the invention device include silk, polyamides, polyesters such as polyethylene terephthalate, polyacrylonitrile, polyethylene, polypropylene, silk, cotton, linen, etc. Carbon fibers, steel fibers and other biologically acceptable inorganic fibroid materials can also be employed.
[0056]The term "non-bioabsorbable" as used herein applies to materials which permanently remain within the body or at least remain in the body for a relatively long period of time, e.g., at least about two years. It is preferred to employ a material which is also elastic, i.e., a polymeric material which in filamentous form exhibits a relatively high degree of reversible extensibility, e.g., an elongation at break of a least about 30 percent, preferably at least about 40 percent and more preferably at least about 50 percent. Fiber-forming polymers which are both non-bioabsorbable and elastic, and as such preferred for use herein, include fiber-forming polyolefins such as polyethylene homopolymers, polypropylene homopolymers, ethylene propylene copolymers, ethylene propylene terpolymers, etc., fluorinated hydrocarbons, fluorosilicones, isobutylenes, isoprenes, polyacrylates, polybutadienes, polyurethanes, polyether-polyester copolymers, and the like. Hytrel (DuPont), a family of copolyester elastomers based on (soft) polyether segments and (hard) polyester segments, and spandex, an elastomeric segmented polyurethane, provide especially good results.
[0057]Hytrel is manufactured in various commercial grades by DuPont, such as Hytrel 4056, 5526, and 7246. Hyrel 5556 is especially suitable when used to form a vascular graft, while Hytrel 7246 is well-suited when used to form a ligament prosthesis or tendon augmentation device.
[0058]Several properties of the various Hytrel grades are presented in the table below:
TABLE-US-00001 Hytrel Grade No. (Injection Molded at 23° C. for Testing) Hardness in durometer points (ASTM Test No. D2240 4056 5526 5556 7246 Flexural Modulus (ASTM Test No. D790) at -40° C. in MPa 155 930 930 2,410 at -40° F. in psi 22,500 135,000 135,000 350,000 at 23° C. in MPa 55 207 207 518 at 73° F. in psi 8,000 30,000 30,000 75,000 at 100° C. in MPa 27 110 110 207 at 212° F. in psi 3,900 16,000 16,000 30,000 AST Test No. D638 .sup.(i)Tensile Strength at Break, MPa 28.0 40.0 40.0 45.8 psi 4050 5800 5800 6650 .sup.(i)Elongation at 550 500 500 350 Break, % .sup.(ii)Tensile Stress at 5% Strain, MPa 2.4 6.9 6.9 14.0 psi 350 1,000 1,000 2,025 .sup.(ii)Tensile Stress at 10% Strain, MPa 3.6 10.3 10.3 20.0 psi 525 1,500 1,500 2,900 Izod Impact (Notched) (ASTM Test No. D256, Method A) at -40° C. in J/cm No Break No Break No Break 0.4 at -40° F. in ft-lbf/in No Break No Break No Break 0.8 at 23° C. in J/cm No Break No Break No Break 2.1 At 73° F. in ft-lbf/in. Resistance to Flex Cut Growth, Ross (Pierced), in Cycles to 100% cut growth (ASTM. Test No. D1052) .sup.(iii)Initial Tear >1 × 106 >5 × 105 >5 × 105 -- Resistance, Die C (ASTM Test No. D1004), in kN/m 101 158 158 200 in lbf/in. 580 900 900 1,146 Melt Flow Rate in g/10 min. 5.3 18 7.0 12.5 (ASTM Test No. D1238) Test conditions: Temperature, ° C./Load, 190/2.16 220/2.16 220/2.16 240/2.16 Kg .sup.(iv)Melting Point (ASM Test No. D3418) in ° C. 148 202 202 219 in ° F. 298 396 396 426 Vicat Softening Point (ASTM Test No. D1525) in ° C. 108 180 180 207 in ° F. 226 356 356 405 Specific Gravity (ASTM 1.16 1.20 1.20 1.25 Test No. D792) Water Absorption, 24 hr. 0.6 0.5 0.5 0.3 in % (ASTM Test No. D570) .sup.(i)head speed 50 mm/min. or 2 in./min. .sup.(ii)head speed 25 mm/min. or 1 in/min. .sup.(iii)specimens 1.9 mm or 0.075 in. thick. .sup.(iv)differential scanning calorimeter (DSC), peak of endotherm
Corresponding properties of other goods of Hytrel are available from DuPont.
[0059]The fibers or filaments forming the linking member can be woven, braided or knitted in whole or in part and will ordinarily possess a relatively high tensile strength, e.g., a straight tensile strength of at least about 30,000 p.s.i., preferably at least about 60,000 p.s.i. and more preferably at least about 90,000 p.s.i.
[0060]Bioabsorbable polymers of high lactide or glycolide content, e.g., those in which at least about 75 percent of the monomeric units are derived from either glycolide or lactide, are preferred for the construction of the linking member 16 of tissue repair device. Typical polymers are disclosed in U.S. Pat. Nos. 4,523,591 and 4,744,365 which are incorporated by reference. Polymers of high glycolide content tend to be absorbed more quickly than those possessing a high lactide content. Accordingly, the glycolide-based polymers may be preferred, e.g., for both the anchoring members 14 and even the linking member 16. An especially preferred lactide-glycolide copolymer for forming the linking member 16 contains from about 70 to about 90 percent, and preferably from about 75 to about 85 mole percent lactide monomer with the balance being provided by the glycolide monomer. Thus, for example, fibers or filaments formed from a lactide-glycolide copolymer based on 80 mole percent lactide-20 mole percent glycolide is especially advantageous for constructing the linking member 16, and ultimately, the tissue repair device of the present invention. When a composite yarn is used to form the linking member 16, then the sheath yarn component, which is preferably braided around the core yarn component, may comprise a plurality of bioabsorbable fibers in turn comprising at least two different chemical compositions. This copolymer is also suitable for injection molding anchoring members 14 about linking member 16.
[0061]As pointed out supra, the various fibers or filaments can be woven, braided or knitted together to form linking member 16. In this regard, the term "braid" or "braided" refers to an arrangement of discrete units or bundles, denominated "sheath yarns," made up of individual filaments with individual sheath yarns interlocking or interlacing each other in a regular criss-cross pattern. For example, a suitable braided suture which can be utilized as the linking member 16 is disclosed in U.S. Pat. Nos. 5,019,093 issued May 28, 1991 and 5,226,912 issued Jul. 13, 1993, the contents of which are incorporated by reference herein. Such braided yarn encompasses core and sheath designs as well as braid over braid designs. The core is optional and can be twisted, ply or cable.
[0062]In another embodiment, the fibers or filaments forming the linking member 16 are woven into a spiroid braid construction. The expression "spiroid braid" and "spiroid braided" refer to various types of a solid arrangement of discrete units or bundles, denominated "yarns", made up of individual filaments or fibers. The yarns are arranged substantially parallel to the longitudinal axis of the suture or linking member 16 and internally engaging each other in a repetitive spiral pattern. The term "solid" is intended to designate a suture or linking member 16 in which the filamentous material of its construction occupies substantially the entire cross-sectional areas of the suture or linking member 16 with at most a minor percentage of such area (not exceeding about 25% in the larger suture sizes) constituting void spaces or interstices between adjacent yarns and fibers. Such construction contrasts with that of e.g., a standard suture which, in the absence of a core component, possesses a lumen representing a significant percentage of the cross-sectional area of the suture.
[0063]Spiroid braided suture component or linking member 16 can also be fabricated from a wide variety of natural and synthetic fibrous materials such as any of those heretofore disclosed for the construction of sutures. Such materials include non-absorbable as well as partially and fully bio-absorbable (i.e., resorbable) natural and synthetic fiber-forming polymers. Examples of spiroid braid constructions which can be utilized as the linking member 16 in the tissue repair device of the present invention are found in U.S. Pat. Nos. 5,133,738 issued Jul. 28, 1992 and 5,181,923 issued Jan. 26, 1993, the contents of which are incorporated by reference herein.
[0064]The present invention is especially suited for preparing the tissue repair device by injection molding which will be described infra with respect to FIGS. 8-10.
[0065]Initially, the mold is opened and the fiber or filament-like material forming the linking member 16 is positioned between projecting pegs 86 and 87 as schematically illustrated in FIG. 9. The mold is then closed by fitting mold portion 80 and countermold portion 80' together in the direction of arrows A and B as shown in FIG. 10. After mold portion 80 and countermold portion 80' are secured together, the thermoplastic material forming the anchoring members 14 is heated to a temperature at which this material becomes flowable. In this regard, the thermoplastic material is preferably heated to a temperature from about 120 to about 240° C., more preferably from about 140 to about 200° C. The thermoplastic material is heated in a plunger machine (not illustrated) remote from the mold portions, an example of which is shown in the Encyclopedia of Polymer Sciences and Engineering citation noted supra.
[0066]The mold portion 80 is provided with proximal ends 180, sidewalls 182 and pointed distal ends 184. Likewise the countermold 80' is provided with such structure. Next, the molten thermoplastic material is injected, under pressure, into the mold cavity defined by recesses or channels 81-85 of mold portion 80 and corresponding recesses or channels 81'-85' of countermold portion 80'. The molten material is injected into the mold cavity through opening 88-88' defined by mold 80 and countermold 80' portions. Injection is carried out from the (non-illustrated) plunger apparatus which is preferably an extruder screw having a nozzle or an end thereof extending into opening 88-88' during injection. In this regard, the molten thermoplastic material is preferably injected at a pressure of about 400 to about 4,000 psi, more preferably about 500 to about 2,000 psi.
[0067]During the injection, the mold/countermold portions are preferably at about room temperature (about 20° C.) so that the injected thermoplastic material will ultimately cool to form the hardened anchoring members 14 about the linking member 16. In this regard, the mold/countermold portions 80 and 80' can be desirably heated to enhance smooth flowing of the thermoplastic material along tracks or recesses 81-85 and 81'-85'. The mold portion can be preferably heated to a temperature up to about 50° C., more preferably up to about 40° C. However, the mold portions 80 and 80' will ultimately have cool to room temperature in order to ensure hardening of the thermoplastic material into anchoring member 14. The channels are formed in mold 80 and countermold 80' portions such that thermoplastic material will not flow into the cavity defined by recesses 89 and 89', i.e. the channel defining the linking member 16. Accordingly, when the molten thermoplastic material is injected into the mold portions 80 and 80', the material will be unable to flow into channels 89 and 89' and will not cover the filamentous or fiber material forming linking member 16 at this point. As a result, flexibility of linking member 16 will be maintained even after anchoring members 14 have hardened upon cooling of the thermoplastic material forming the same.
[0068]Injection is carried out until the cavity defined by channels 81-85 and 81'-85' is completely filled with thermoplastic material, i.e. the thermoplastic material can no longer flow into the mold cavity through opening 88-88'. After injection is completed, the thermoplastic material is allowed to cool and set within the mold cavity to form anchoring members 14. Preferably, the thermoplastic material is allowed to cool and set after injection is completed for about 0 to about 1 minute, more preferably from about 1 to about 8 seconds.
[0069]After the injected thermoplastic material has sufficiently cooled and solidified, then the mold and countermold portions 80 and 80' are opened and the molded part contained therein removed from mold portion 80. The gates formed on anchoring members 14 (where channels 84 and 85 respectively meet channels 82 and 83 in mold portion 80) are cut, preferably by means of a manual or powered cutting tool, so that anchoring members 14 are separated from the thermoplastic material that has solidified along channels 81-83. The resulting product 90 is shown in FIG. 11 and comprises anchoring members 91, 91' secured to flexible material 92 forming the linking member. The tips 93, 93' of respective anchoring members 91, 91' can then be secured to appropriate needles, e.g., by adhesives, crimping, swaging, etc.
[0070]The mold and countermold portions 80 and 80' along with the molding cavity formed therebetween can have any suitable dimensions required for molding a suture repair device. For example, the length of the entire product shown in FIG. 11 (from tip 91 to tip 91') is preferably about 0.120 to about 6 inches with the corresponding length of each anchoring member 91, 91' about 0.040 to about 2 inches, leaving an exposed area of filament-like flexible material 92 of about 0.040 to about 2 inches in length. Dimensions of the molding cavity formed by tracks or recesses 81-85, 89 and 81'-85', 89' can be accordingly prepared to mold the product 90 possessing these dimensions. The length of material 92 cut and positioned within tracks or recesses 84, 85 and 89 as shown in FIGS. 9 and 10 will naturally vary depending upon the appropriate dimensions of these tracks.
[0071]As noted supra, the structure of flexible material 16 which is preferably filamentous or fiber-like, can be woven, braided or knitted, e.g., take the form of a tubular or solid spiroid braid. The material forming the linking member 92 can be different from, or even the same as the material used to form anchoring members 91, 91' shown in FIG. 11. In other words, linking member 92 and anchoring members 91, 91' can be formed from the same material which possesses greater flexibility in a filament or fiber-like condition (linking member 92) than when present as a solidified mass of previously molten thermoplastic material (anchoring members 91, 91').
[0072]However, preferably the linking member 92 (FIG. 11) is constructed out of material such that the portion of the braid that contacts the molten thermoplastic material will itself undergo a partial melting. The braid will then fuse to the molten material as the material cools and hardens, forming a strong secure bond between flexible linking member 92 and substantially rigid anchoring members 91, 91' which will not prematurely fail prior to and during insertion into tissue. Typically the length "L" of linking member 92 extending from anchoring member 91 to anchoring member 91' is in the range of about 1 mm to about 50 mm. Typically, length "L" is sufficient for anchoring members 91, 91' to be arranged parallel after solidification.
[0073]It is possible to mold a series of tissue repair devices formed along single, extending strands or ligature of flexible material which can then be severed at appropriate locations to form multiple tissue repair devices. The molding procedure to form a series of these devices is the same as the molding procedure described supra, the only difference being that mold and countermold portions define a cavity for retaining a length of flexible material with appropriate recesses positioned therealong to mold several anchoring members along the length of the flexible material. An example of such a mold portion 110 is shown in FIG. 12 which is a partial view of the same. The mold portion 110 is provided with proximal ends 280, sidewalls 282 and sharp pointed distal ends 284. As can be seen in this view, the tracks or recesses 94-97 defining the flow of molten thermoplastic material are substantially identical to tracks or recesses 82-85 in the mold portion 80 shown in FIGS. 8-10. Additionally, tracks or recesses 100, 101 and 102 are provided for retaining a length of flexible material 16 between the respective tracks or recesses 96, 97, etc. for molding anchoring members. Tracks 101 and 102 are offset from respective recesses 120/97 and 96/121 as illustrated in FIG. 12. Respective projecting pegs 122/123 and 124/125 are also provided on either side of tracks 101 and 102. The countermold portion for this mold apparatus also comprises tracks and recesses forming the exact mirror image of tracks 94-97, 100-102, 120-121, etc. of mold portion 110 with the exception of recesses being provided to receive projecting pegs 98, 99, 122, 123, 124 and 125 when the mold and countermold portions are secured to one another.
[0074]An example of the product prepared with the mold of FIG. 12 is shown in FIG. 13 (after removal of the gates therefrom) where a series of tissue repair devices 103, 104, 105 (in part) are illustrated with respective anchoring members 106, 106', 107, 107', 108, 108' (not illustrated) molded about the flexible material having exposed sections 111, 112, 113, 114, 115. The mold tracks 101 and 102 have been positioned in the mold portion of FIG. 12 such that the exposed sections of flexible material 115, 112, 114 positioned therein are offset from the tips 130-134 of the respective anchoring members. It is particularly preferred not to have the flexible material pass through the points of tips 130-134. This preserves the sharpness of the points of the respective anchoring members. After injection molding has been completed and the resulting repair device series removed from the mold with the gates being severed, then the flexible material is cut at the appropriate locations, i.e., at exposed sections 109, 112, 114 to form the individual tissue repair devices 103, 104 and 105. Anchoring members 106, 106', 107, 107', 105, 105' can then be attached to appropriate needles by the methods described supra or left alone.
[0075]The tracks or recesses formed within the mold cavity can take any convenient size or shape to ultimately form a tissue repair device having any suitable dimensions or shapes. for example, the mold cavity can be configured to mold a tissue repair device 140 illustrated in FIG. 14 where unlike the devices illustrated in FIGS. 11 and 13, the anchoring members 141, 141' do not possess barbs (reference numeral 142 denotes the linking member).
[0076]FIG. 15 shows additional details of a mold 210 employed with the present invention. A length of flexible material 200A enters the mold at entry port 210, passes along a track 202, past a peg 244 and into a recess 296. Recesses 296 and 297 communicate with tracks 294, 295 to provide a path for molten polymer. Flexible material 200A passes from the recess 296 along a channel 200 between pegs 222 and 233 and into and out of recess 297 as illustrated in FIG. 15. Then, the material 200A passes along a channel 201 past a peg 255 and exits the mold 210 at exit port 300. Leaf springs 302, 304 are respectively located at the entry port 210 and exit port 300 and are attached to the mold 210 by respective bolts 306 and 308. FIG. 16 illustrates an enlarged view of a portion of the mold 210 in the direction of arrows A-A in FIG. 15 in addition to a portion of countermold 210A mating with mold 210.
[0077]The following examples are illustrative of the fabrication of a tissue repair device in accordance with the present invention.
Example 1
[0078]A length of about 0.25 inches of spiroid braided flexible material formed of a copolymer of glycolide and lactide of approximately 18 mol % glycolide and 82 mol % lactide is cut and placed in mold portion 80 as shown in FIG. 9 in the channel 89 between projecting pegs 86 and 87. The mold 80 and countermold 80' portions (FIG. 10) are then secured together. Then, material of the same composition is separately heated to a temperature of about 150° C. so that the material melts and is in flowable condition. Next, this molten flowable material is injected into the mold cavity under a pressure of about 2,000 psi., until the mold cavity is completely filled with the molten, thermoplastic material, i.e., the material can no longer flow into the mold cavity. The mold cavity itself, i.e. mold parts 80 and 80', are at a temperature of 15° C.
[0079]After filling of the mold cavity with the thermoplastic material is completed, the mold portions 80 and 80' are allowed to cool to room temperature over a period of about 2 seconds, at which time the thermoplastic material has solidified into fairly rigid members 91, 91'. The mold cavity is opened and the gates attaching members 91, 91' to the solidified material in tracks 82 and 83 are cut, resulting in the tissue repair device illustrated in FIG. 11 and which is then attached to needles at points 93, 93' thereof.
[0080]The above procedure is also carried out with tubular braided material of the same composition to form linking member 92.
Example 2
[0081]The procedure of Example 1 supra is repeated in its entirely but with about 4-6 inches of a U.S.P. size 2-0 braided suture material composed of about 92.5 mol % glycolide and about 7.5 mol % lactide as the flexible material 92 and a copolymer of about 92.5 mol % glycolide and about 7.5 mol % lactide as the molten thermoplastic material hardening to form rigid members 91, 91'.
[0082]While the invention has been particularly shown and described with reference to the preferred embodiments, it will be understood by those skilled in the art that various modifications and changes in form and detail may be made therein without departing from the scope and spirit of the invention. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.
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Patent applications by Daniel R. Lee, Madison, CT US
Patent applications by Steven Howansky, Wilton, CT US
Patent applications by Thomas W. Sander, Winona Lake, IN US
Patent applications by Wayne C. Person, Newtown, CT US
Patent applications in class Including ligament anchor means
Patent applications in all subclasses Including ligament anchor means
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