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The country's total capacity exceeds 9.5GW and is likely to reach 10GW by the end of the year. Other star performers in Europe - but trailing some way behind - were Sweden and Turkey, each adding about 250MW, while Spain and Italy continued to make steady progress.
In Asia, China maintained its regular frenetic progress, putting 3.3GW online. India added nearly 1GW, but uncertainties over grid connections may be inhibiting progress.
Growth in the US seems likely to pick up with the re-establishment of the production tax credit, but the net additions so far this year are quite modest. The US takes the top spot for wind in Ernst & Young's Renewable Energy Country Attractiveness Index, which suggests the rate of installation may accelerate. The professional services firm believes the PTC may be extended.
There is currently 2.3GW of US projects under construction, according to Windpower Monthly market research unit Windpower Intelligence and Data (WPI). And the American Wind Energy Association reported at the end of the first quarter of 2013 that 18 requests for proposals had been issued across several states.
China, Germany and the UK follow the US in Ernst & Young's league table of Wind Energy Attractiveness Indices, for onshore wind. These have generally been strong performers and may help to ensure that installations in 2013 match those of 2012. The UK government did recently unveil policy proposals that some in the wind industry initially worried would make certain projects unviable. Details are still emerging, and recent analysis of the policy suggests net impact on wind may be negligible.
Australia comes fifth. Growth of installed capacity has been robust and, according to WPI, building has started on 1.34GW of projects, six of which are expected to go online this year. The wind resource, meanwhile, is excellent and of more than 19GW of proposed projects, 6.72GW have permits in place. Electricity can be supplied from a new wind farm in Australia at a cost of $82/MWh, compared with around $147/MWh from a new coal-fired power plant or $116/MWh from a new station powered by natural gas when the cost of carbon emissions is included, according to a Bloomberg New Energy Finance (BNEF) report published in January (see page 33).
The Attractiveness Index for offshore wind puts the UK in the top spot, followed by Germany, China, Belgium and Denmark. The UK is firmly at the top of the capacity table, with 3.32GW installed and a substantial quantity in the pipeline. The offshore wind index has the US in sixth place. Alhough the country so far does not have a single offshore wind project installed, 32 projects with nearly 20GW cumulative capacity have been proposed, according to WPI. Six, totalling 872MW, have permits. Of these, the best known is Cape Wind, off Cape Cod in Massachusetts, which seems likely to be the first to be built. US companies are also taking a considerable interest in worldwide research and development, including floating offshore wind-turbine concepts.
The competitive position of wind is continually strengthening (see page 33), fuelled partly by rising gas prices and partly by falling wind-turbine prices. With market build capacity currently exceeding demand, this price trend can be expected to continue, says BNEF.
First-quarter earnings reports from major manufacturers reflect some uncertainty over likely growth in 2013. While the renewal of the US production tax credit was welcome, it came too late to arrest a dip in wind turbine orders at the start of the year. There are encouraging signals, however, that wind turbines are becoming ever more reliable and this is reflected in lower operation and maintenance costs, plus longer guarantee periods. Wind turbines are also continuing to grow in size: Vestas, for example, reports that construction and testing of components for their 8MW, 164-metre diameter wind turbine is now well advanced. The prototype is expected to be installed next year. Meanwhile, Siemens has installed two 6MW prototypes at an offshore wind farm off the English east coast. Continuing advances in technology mean substantial sums are still being spent on research and development. The European Wind Energy Association expects spending of EUR1.74 billion in 2013-15, with about 30% coming from the EU. In its European Wind Initiative: Wind Power Research and Development to 2020 report, EWEA encourages yet higher funding and proposes a structured research programme in several areas. The sector is maintaining its footing in difficult times.


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Please understand what it is like to be pregnant and unsupported: two women appeal to MPs
'I just wish that people had more of an open dialogue about what pregnancy really means to you as a woman'
Dear Senator Bernardi,
There has been a lot of talk in the media about your recent comments about abortions. I thought I would share my story with you.
Being in a toxic relationship and discovering you are pregnant is one of the most intense pressure cooker situations a woman can be in. My pregnancy was unplanned – I was taking the pill YAZ and it failed. I am university educated, 32 years old, middle income earner, lived in the eastern suburbs of Sydney, my parents are still married and I have a harmonious family life.
When the two pink lines appeared I was told in no uncertain terms I would be having an abortion- and I was to understand my partner was only looking after himself and I'd "better not try to screw him over", I was then kicked out of the house in the rain and had to walk home.
He then disappeared into nights of drinking with his best friend under the banner that his best friend needed "support" while his pregnant girlfriend sat on the couch at her house freaking out- oh of course I got the 11pm " How are you? You will be getting an abortion its nothing, it's just a process stop looking for attention" message. Great father material wouldn't you say?
It was a terrifying future would my measly salary cover the cost of a child? Would I be able to maintain my apartment? I've never been inside a centrelink office in my life I wouldn't have a clue where to begin. Would I be able to cope with the stigma narrow minded people – such as you- place on single mothers? It was clear this would be my only option. Would I be able to form another relationship? How would I go about getting external help?
And was it indeed my fault? My ex certainly seemed to think so. Did I make this happen? Should I have done something differently?
If I had an abortion how would I cope? Was I going to be ok? It was more than obvious my sham of a hetero sexual relationship was completely loveless – was it right to bring a child into the world with no father? It may well be my right to choose – how was I to make this life defining choice? Could I cope with the very real very scary physical and psychological side effects of a termination? All the literature told me it was no big deal- but it felt like a big deal and the consequences were enormous.
All this and my hormones were out of control.
You know who supported me? My gay best friend. He was on call with listening to me agonize over what to do, running through all the options offering total unconditional love- as were my parents.
I had my scan – my "partner" refused to attend, my mother held my hand -I decided to keep my son. I take no moral high ground here I made the choice that I felt was right for me.
The terror remained and it was only going to get worse. I lost my son in extremely traumatic circumstances.
Oh the guy? Ran away but not before he abused me one last time advising I was disgusting and deserved what happened to me. But nothing is more sacred than the love between a man and a woman right?
Here's the true tragedy- my story is not uncommon.
Your remarks show you can't possibly comprehend what a woman is thinking when there is an ambiguous pregnancy, nor does it offer empathy to my hetero sexual abusive relationship situation.
When I was a little girl I didn't say "when I grow up I want to have an unplanned child to an abusive manipulative man and terminate it because I feel trapped by the stigma of society, the belief and social assurances that I can't do it on my own."
To trivialise abortion as used for "birth control" undermines the difficulty of the decision. I have spent a lot of time with women who have had abortions all, not one or two but all, found it to be an agonizing decision. Your statement shows you haven't researched correctly and lacks empathy.
I wouldn't change decision to keep my baby, it was the right one for me. Do I wish things had been different? Absolutely – the loss of my son has been the hardest, most cruel and shocking experience of my life. I actually didn't know pain like this existed. Even now the shock of it all still affects me, especially coming up to one year since he grew his angel wings.
I just wish that people had more of an open dialogue about what pregnancy really means to you as a woman- and extended empathy rather than sitting in judgement.
Pro life, Pro choice, I'm actually Pro woman.
' When I was pregnant at 15 I needed support'
[This to Victorian MP Bernie Finn following a vitriolic debate on one of my Facebook pages which I have been forced to shut down]
Dear Mr Finn,
I am a pro life woman. I believe mothers and babies should be embraced and supported by our community. I believe laws should protect life before and after birth. Please enact the following:
- Illegal to pressure girlfriend or wife to have an abortion.
- Illegal to harass pregnant mother to the point of physical and mental health breakdown, with stronger penalties applied. (FYI, Maternal stress is linked with future health problems in the unborn child as well as the mother).
- Stronger restraining order laws. I was afraid to apply for child support and wrote "father unknown" on the birth certificate to avoid being compelled to do this.
- Illegal for mentally ill, depraved and criminal father to come back into child's life 12 years later, using Legal Aid and the family court (successfully) to harass and intimidate mother, to undermine child's education, to harass and threaten teachers, to cause depression/anxiety/trauma for mother, to escalate and encourage child to rebel against mother and society, cause mental health issues in child, resulting in psychiatrist paid for by mother. All of this allowed by the court with no penalties.
- Illegal to lie to the child support agency about paternity.
- Illegal for father to pose as a teenage girl to stalk child on facebook and actively encourage him to defy his mother with this fake female personality.
- Illegal for father to then claim child support off mother after successfully encouraging child to run away from home and live with him, even though she was afraid to claim child support for 12 years.
- Illegal for father to give child weapons.
- Illegal for father to give child drugs, alcohol and pornography.
I could go on and on sadly. The legal correspondence goes on for miles. I became used to my lawyer advising me that the court would do nothing about his behaviour, despite his violent criminal history, prison sentence, numerous stays in mental institutions and his then current mental health forensic order. I visited the police station almost weekly with new information and became used to them literally shrugging their shoulders at me.
I don't share my story often because I'm afraid it will make girls afraid to have their babies. Who would want to be forever tied to an abuser in this way? When I was 15 and pregnant, the legality of abortion didn't enter my mind, I had never thought about it. But I did need the law to protect me and my child from the child's father. Existing laws were and still are, woefully inadequate.
When I was 15 and pregnant, what I needed was genuine support, someone to walk alongside me, a true friend, a mentor. We need to funnel more resources into organisations who provide this support in order to help more women and girls.
I see that women's stories of unexpected pregnancy have changed very little in the almost two decades since I had a baby. Please change the laws so that no woman or girl – or their child – has to endure what I have endured.
Anonymous for my safety

subset: commoncrawl


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Baked Cuttlefish from Squidy is one of the Thailand's favorite fish snack. Squidy is crispy and delicious. Squidy is made from original recipe with highly technology food processing to maintain all food nutrition. Ingredients : cuttlefish, sugar, salt, chili, soybean sauce. Net weight 90 grams. Product of Thailand.
Copyright © 2004 - 2019 GroceryThai.com


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22 Inch dark auburn Indian Remy Hair Extension 125g USS3322
- Featured Service
- Hair Care
Featured Service
Top color can be customized as the shade of your natural hair to achieve a well-blended final look.
For some complex sets, pictures of the finished item(s) will be sent to your email address for confirmation before shipment.
Please email the exact hair color you want to email@example.com after placing order. Any idea or confusion, please also contact us in time.
Hair Care
Before and after using, please remember to brush your Hair Extensions kindly with a soft bristle brush or a wide tooth comb. Make sure all knots and tangles are gone.
We suggest only washing your Hair Extensions every 15-20 wears. The less you wash your extensions, the longer they will last.
Gently wash your Hair Extensions in lukewarm water, choose sulfate-free and alcohol-free shampoo. Rinse out the shampoo and apply hydrating conditioner. Rinse thoroughly. Coconut oil and hair mask are also helpful.
Never comb through your Hair Extensions while they are wet and only use hot tools when they are dry.
Always remember to use heat protecting spray when using hot tools such as flat irons or curling wands. And we recommend only using low to medium heat settings.
Most importantly, treat your Hair Extensions with care by storing them in a dry and flat place.
22 Inch dark auburn Indian Remy Hair Extension 125g USS3322
In the female world, hair plays a great social and important significance. This fine quality of hair extension is a great technique to promote your style and healthy looking hair. This can add length, volume and fullness while matching the exact colour of your original hair strands. On the other hand they are also not so costly. You can use it for any occasion and enhance your natural look.
- Description
Product DescriptionDetailsPicture Hair Length: 22″
Picture Hair Colour: 33#
Hair Quality: 100% Indian Virgin Human Hair extensions
Heat Friendly: Yes
Texture: silky straightProduct DescriptionAvg. Product Life:exceeds 1 year
Wefts:8 Pieces
one 8" wide wefts(4 clips)
one 7" wide wefts(4 clips)
two 6" wide wefts(3 clips)
four 2" wide wefts(1 clip)
App. Method:Clip-In
Approx. Weight:125gTailoring Time7-10 business daysShipping TimeFree Ships to: US,Canada,Australia
or most Western European
Standard: 2-3 business daysreturn policy
- Reviews (2)


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Raiding and fun
I've been watching the ongoing squabble about the importance of 25 man raiding, and how the increased 10 man raiding is going to destroy WoW, and think I want to stick my two cents into the thing.
While it's not quite this simple, there's an important thing to recognize. There are several million players out there who will never, ever see a 25-man raid, but who've managed to get to the 10-man raids. If you're blizzard, do you continue to interest the 5% of the paying players who can manage the 25s, or the 60% who can manage the 10s?
I think it's important to recognize some of Blizzard's incredible strengths – reasons why Wow has done so well for so long. One that gets noted and then forgotten – probably the BIGGEST – is that they aim for center mass, not the bleeding edge. WoW, even with TBC, will run on a Dell Latitude 110L (1.3G Celeron) with a mere 1GB of memory. The pipe to the servers need not be huge – 56k dialup works. Instead of playing to the bleeding edge only and leaving the masses drooling, it allows the masses to play. Other companies envy the player population, then screw it up by only targetting the handful with power machines.
This is not a new Blizzard phenomenon. It's instead the norm – aim for the middle. Have some candy for those who CAN run the edge, but make sure everyone can get meat.
25-man raids is candy for the edgers. 10s are meat for everyone. The balance is ensuring the masses don't think they're missing meat – rarified meat, but meat nonetheless. And the reality is… they were. Kara, ZA, and then… go start another character. That narrow edge of players, on the other hand, got hours – days – more play out of the game, seeing sights that most will never achieve. And that, friends, is contrary to the model that has made WoW stay so successful.
It's a game, and several million people are paying a token fee every month to have fun. And if 10% leave for the new bleeding edge, but 90% stay not only because they don't have machines that'll handle that edge but because there is new stuff that they can do… it's worth the loss.
Should the 25s be a 'bit more'? Yes. Should there be a goal only a few can reach? I think so – I think the knowledge there's a bit more is part of the appeal – it prevents the "well, finished it all. next game?" problem. But the trick is to make sure that unattainable candy isn't a mountain, but rather a teaser.
And Blizzard may have figured out a better balance. We won't know, of course, for another year. But my gut feel is that they've succeeded in this regard.
I'm not so sanguine about the level 70s and Death Knights, but that's a different issue.


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Natural gas has many benefits. Switching to gas makes sense because it is:
Natural gas prices have hit a 10-year low during the past five years due to its abundant, domestic supply. Compared to other fuels, the cost of natural gas is expected to remain low into the future.
SOURCE: The above costs are based on actual market prices for Delaware area, U.S. Energy Information Adm. The heating season price comparison is Nov.-March. Fuel consumption depends on winter temperatures. The above consumption levels are based on average residential use during an average winter, five-month period for the Delaware area. This chart reflects an estimate of the potential savings associated with converting to natural gas as your heating source. Individual results may vary based upon a number of factors. Delmarva Power makes no representations or warranties of any kind or nature, either express or implied, as to the particular savings that a customer may experience, if you are converting to natural gas.www.eia.gov/special/heatingfuels.
Compare your home's heating costs using our Switch to Gas Calculator
If you live within our service territory (New Castle County, Del.) and want to switch to natural gas, please fill out this customer contact form, including the validation image and click "submit." We will let you know what, if any, costs there would be to bring natural gas directly to your home. You may also call us regarding your switch to natural gas at 302-429-3117.
For more information on switching to natural gas, read our
Frequently Asked Questions.


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Announced at IFA 2011, the Galaxy Note quickly became one of Samsung's Android flagship devices, and the company has been selling quite a few units in the recent months.
In case you have recently purchased the device and you're still discovering its secrets, we'll show you a few Galaxy Note tips and tricks, which have been conveniently posted on the company's Facebook page a few months ago. Here's what you should know about the Galaxy Note's hidden features:
- The keyboard can be optimized for one-handed operation
- S Pen gestures can launch button functions
- S Memo lite launches in just two taps for instant memo taking
- With the S Pen you can write and draw on any screen
- S Memos can be zoomed in for more detailed use
- Subtle details make the S Memo experience even better
- S Memo is more than just a memo application–it captures photos, records audio, and more
- S Pen makes it easy to freely cut out a specific part of a picture
- A screenshot shared to an S Memo is linked to its original website
- Combining two S Memos automatically organizes them into a folder
- Text messages can be handwritten to share your emotions better
- Emails can be drawn to be worth a thousand words
- S Memo lite can be hidden to reveal the background
- Photo editor lets you get expressively creative
- Annotations can be made directly on PPT documents
- Handwritten memos can be added into schedules
- Handwriting can be added to video to add some personality
- Schedules can be easily managed with intuitive gestures using S Planner
- Schedules can be easily managed with intuitive gestures using S Planner
- Touchnote, postcards can be designed with the S Pen and sent to a physical address
- S Pen makes playing Crayon physics much more enjoyable
- Using Touch Retouch, making people disappear is easier than a magic trick
- Anybody can draw zen-inspired paintings
- With just a little imagination, creating a comic strip is as easy as using the S Pen
- Project collaboration is possible 24/7 with anyone and anywhere
Check out the full gallery below:
[nggallery id=5]
Do you have any Galaxy Note tips and tricks of your own?
Read comments


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Diagnose student difficulties in key foundational math skills necessary for success in mathematics. Comprehensive Assessment of Mathematics Strategies (CAMS®) gives you the information you need to target instruction and measure progress in topics that align to NCTM Focal Points and Connections.
To create a quote, add the quantities you'd like to purchase and select the action at the bottom of the form. Your items will be automatically added to your quote.
CAMS assesses mastery of key foundational math skills and concepts, with a balance between computational fluency and conceptual understanding.
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CARS® & STARS® Book Collection


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You went to the grocery to get a quart of milk and came home with an orchid. How did that happen? An even more pressing question might be, "What do I do with it?" Don't panic. Just follow a few basic guidelines, and you should be able to keep your plant alive and even re-bloom it.
This is the most critical step. More orchids are killed with kindness (overwatering!) than anything else. Put your finger in the growing mix. If it feels moist, don't water until the mix feels dry. If the mix is dry, water it at the kitchen sink until the water runs through the pot. Never let the plant sit in water. If in doubt, don't water.
Your orchid is probably a Phalaenopsis, the most popular orchid in displays at groceries and box stores. Phalaenopsis have broad, flat leaves and stems of white or brightly colored flowers. They like low light conditions and do best in east-facing windows. They also do well in southern or western windows. But don't place your plant next to the glass of a western window because the sun's rays could burn its leaves. Northern windows do not receive enough light for your plant to re-bloom.
Like you, your orchid will be most comfortable if the temperature is between 60 degrees F and 80 degrees F. You will increase its chances of re-flowering if your house is cooler at night than during the day. A drop of 10 F is not too much. A night rest allows it to save energy it has made during the day from photosynthesis. Think of this as a plant-energy savings account that pays dividends in flowers.
Use a fertilizer made for orchids. These are readily available at garden centers. Follow package directions. A good practice is to fertilize for three waterings and flush with clear water at the kitchen sink on the fourth watering to remove fertilizer salts.
This is the biggie. People usually have a Butterfly McQueen-type reaction to repotting an orchid. McQueen, as the maid, Prissy, in "Gone With the Wind," famously exclaimed: "I don't know nothin' 'bout birthin' babies!" Repotting orchids is nothin' like "birthin' babies." As soon as the plant finishes flowering, cut off its flowering stem, remove it from the pot, ease as much potting mix off the roots as possible (swishing in water helps) and repot it in a plastic container just barely bigger than the root ball — no matter how large the leaves are. Orchids like to be under-potted. Mixes found at garden centers should do fine. Work the mix around the roots until the plant is snug in the pot and you can pick it up by the stem and it does not come out of the pot. Be careful not to break off any tender green or brown root tips, and don't force roots that want to wander in the air into the pot.
Because your plant is probably a Phalaenopsis, a decrease in day length and night temperatures usually helps it to begin the flowering process. Because these conditions naturally occur in the fall, place your plant outside at night as long as temperatures are above 55 degrees F. Be sure to put it where dew will not collect in the crown. Bring it inside during the day unless it's located in a spot where it will not get direct sunlight. Hopefully, you'll have flowers in January or February. If not, there will be more orchids in your grocery strategically placed for an impulse buy, which may be how your plant came home with you to begin with.
See also:
• RA 5-step guepotting orchids


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I am writing a plugin using Python and currently using methods that set the label similar to those seen under Layer Properties. Some of the features under the new labelling engine available on the Toolbar would be useful, such as (not) "Label every part of a multi-part feature" and avoiding label collisions. Also the look of the labels generated using the latter method are usually better. Is there any way of setting these programatically in Python?
I understand the Toolbar labelling system will supersede the version under Layer Properties, so if they are not available in the API, will they be in the future?


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Riverside Police Department
Safe In His Arms Memorial
Located in front of the Riverside Police Department's Orange Street station, the "Safe In His Arms" memorial depicts a Riverside police officer caring for a small child. The memorial lists the names of all the law enforcement officers killed in the line of duty in Riverside County.
Erected in May of 1983, the memorial is "dedicated to all Peace Officers who cope with the day to day rigors of their chosen profession, and honoring those within the county of Riverside who gave their lives in the service and protection of your community, lest we forget, our indebtedness to them..."
|John Baird
|December 15, 1912
|Del McIntyre
|July 14, 1917
|Clinton L. "Tex" Burtner
|December 4, 1938
|Edward Bertino
|February 4, 1940
|Arthur Simpson
|March 5, 1944
|Paul Teel
|April 2, 1971
|Leonard Christiansen
|April 2, 1971
|William Prettyman
|December 12, 1973
|Larry Walters
|November 13, 1974
|Phillip Trust
|May 13, 1982
|Dennis Doty
|May 13, 1982
|Gary Cavender
|July 30, 1993
|Claire Connelly
|July 11, 1998
|Charles Doug Jacobs III
|January 13, 2001
|Ryan Bonaminio
|November 7, 2010
|Michael Crain
|February 7, 2013


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About Room Sprays & Room Fresheners
Make room for effortless home fragrance! Our room fresheners like our lavender spray and bathroom sprays refresh your home with just a burst of fragrance. Our pillow sprays and mists help you fall asleep surrounded by your favorite aroma. Looking for more ways to give your home a scent-sational experience? Shop our selection of wax warmers and melts.


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School rankings provided by The Fraser Institute. Rankings are from 1 to 10.
Like its namesake, Quartz is multi-faceted. Different angles, different shapes. Layers upon layers with a consistent resonance that will transform the skyline as much as it will transform the lives of the individuals residing within.
Trademarks owned or controlled by The Canadian Real Estate Association. Used under license.
The information provided herein must only be used by consumers that have a bona fide interest in the purchase, sale or lease of real estate and may not be used for any commercial purpose or any other purpose.
Information is deemed reliable but is not guaranteed accurate by TREB.
Toronto Real Estate Board - IDX Last Updated: 12/13/2019 2:28:46 PM


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By ,
Published November 21, 2015
Authorities say 16 children and the bus driver were injured when a school bus carrying 40 children was toppled in a crash.
California Highway Patrol spokesman Joaquin Zubieta says two of the children have "serious but non-life threatening" injuries. They were taken to Loma Linda University Medical Center after Thursday's accident.
Ten others were also transported to hospitals. The remaining four were treated and released at the scene.
The accident happened when a U-Haul truck collided with the school bus, leaving it on its side.
The children were being taken home from Galileo Academy in Victorville when the collision happened shortly after 2 p.m.
Two people in the U-Haul truck were not hurt.
An investigation is under way.


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A new book is about to solve a long standing pop-culture mystery: just who is the woman referenced in the title of Billy Joel's hit song, "Uptown Girl?"
In "The Girl in the Song" by Michael Heatley and Frank Hopkinson, they reveal that the song was not an ode to Christie Brinkley, who appears in the song's video and was later Joel's wife, but rather supermodel Elle MacPherson, reports the New York Daily News.
The backstory is that Joel was on vacation in the Caribbean when he saw three models that happened to be staying in the same hotel: Brinkley, McPherson and a not-yet-famous Whitney Houston. Joel eventually dated MacPherson and originally planned to name the song "Uptown Girls" in honor of the beautfiul trio.
However, once Joel started dating Brinkley, he made the title singular in honor of his future wife.
The book also reveals the inspiration behind other famous songs. Joan Baez was the spark for Bob Dylan's "It Ain't Me Babe" and Leonard Cohen's "Chelsea Hotel No. 2" had its grounding in a tryst between the Canadian crooner and 60's wild child Janis Joplin that occured at the famous hotel.
Selected Reading: New York Daily News, Newser, Yahoo


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China is ordering local officials to stop using threatening slogans to enforce its strict "one-child" policy, state media reported.
The government wants to ban slogans like: "Kill all your family members if you don't follow the rule" and "We would rather scrape your womb than allow you to have a second child," the Shanghai Daily said at the weekend.
China, the world's most populous country with more than 1.3 billion people, introduced the "one-child" policy in 1979.
Despite calls for relaxation, Chinese officials say the policy is still needed, claiming overpopulation threatens the country's development.
However, the National Population and Family Planning Commission aims to prevent zealous local authorities from offending the public or worsening social tensions with "nasty" slogans, the newspaper said.
Several referred to forced sterilization, with one slogan reading: "If you don't have your tubes tied, your house will be demolished."
"Once you are captured, your tubes will be tied. Should you escape, we'll hunt you down. If you attempt suicide, we'll offer you either the rope or a bottle of poison," another read.
The newspaper gave no indication of where the slogans were used.
China, under a 1980 policy designed to control its population, permits most couples to have only one child, an approach critics charge is backed by forced sterilizations and abortions.
Some experts say the "one-child" policy has turned into a demographic time bomb as the population ages, storing up huge economic and social problems for the country, as well as fostering a gender imbalance.
Given the traditional preference for sons, sex-specific abortions occur and female infanticide and the abandoning of baby girls have also been reported.
New slogans which have received the government's nod of approval include: "Caring for a girl means caring for the future of the nation," the newspaper said, in an effort to encourage families to raise daughters.


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Top 10 Worst Changes Made to Star Wars
Maybe in a galaxy far, far away, fans are celebrating like Wookies on Life Day the changes George Lucas has made to his Star Wars saga, but not in this one.
The rampant success of the original trilogy and new advances in technology have allowed Lucas to continually tweak (or, as some see it, drastically doctor) scenes in re-releases. In the name of smoothing the continuity of the saga, Lucas has upset dedicated followers who feel the changes to the intergalactic opus have diminished its value.
Following the release of the 2004 DVD box set, Lucas told the Associated Press that the original films were only "25 or 30 percent" of what he wanted them to be. In regard to the outcry over his changes, Lucas was unrepentant. "This is the movie I wanted it to be, and I'm sorry you saw half a completed film and fell in love with it," he said. "But I want it to be the way I want it to be." That doesn't mean Lucas doesn't sometimes side with the fanboys. He's been spotted wearing a t-shirt with their battle cry: "Han Shot First."
Today, the Blu-ray box set of Star Wars: The Complete Saga hits stores. The nine-disc set ($79.99) includes the six films and three additional discs of never-before-seen special features like deleted and alternate scenes. Not surprisingly, it also comes with more production changes that might reduce lightsaber battles to heated thumb wars.
PCMag has rounded up the top ten most controversial changes made to Star Wars films. But, as Lucas said, "The thing about science-fiction fans and Star Wars fans is they're very independent-thinking people. They all think outside the box, but they all have very strong ideas about what should happen, and they think it should be their way." So please, leave your "strong ideas" in the comments section below.
1 10. Ewok Closes its Eyes...and Then Opens Them
2 9. The Dramatic Destruction of the Death Star
3 8. Obi-Wan's Krayt Dragon Call
4 7. Lightsaber Lumination Gets Dull
5 6. The Max Rebo Band Sells Out
6 5. Yoda Meets CGI
7 4. Ewok Celebration Goes Galactic
8 3. Shaw's Spirit Disappears
9 2. Darth Vader Says "Noooo"
10 1. Greedo Shot First


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He was as surprised as anyone when his solo show at La Luz sold out. "I thought, 'Wow, this is amazing! I'm successful!'"
Although Agle continued doing commercial art for several years, today, with rare exceptions, he sticks to fine art. "With commercial art," he says, "you are usually directed in what you do. But with fine art, I can do whatever I want."
Shag has also cut back on his merchandising—cups, T-shirts, and the like. At first, he says, "any company that wanted to license, I said yes." Today, any new Shag product will be a limited edition—and high-end. Look for some $120 Hawaiian shirts.
"Licensing the images served its purpose," he says, "it got my artwork out there for people to see."
He may not be a Peter Max, but Agle does attend to marketing, using both a licensing and a commercial agent. He directs overall strategy.
Chief among his strategic decisions is: Agle does all the artwork himself. With assistants, he says, "There could be questions. Is it really an original?" He also sells through galleries, not on his own. "People were saying the gallery system is dead, you should sell on your Web site. But having a gallery adds legitimacy," he says.
In real life, Shag is unlike the characters that populate his paintings—though he does enjoy a cocktail; and he and his wife, Glen Way-Agle, like fondue. He does not smoke. These days he's listening to Weezer and the Kills, along with organ jazz. Since Zoey, 10, and Zach, 6, came along, Agle rarely makes the scene. But at his art openings, Shag does make a splash, driving up in a classic car and sashaying through in a vintage suit.
But he's too nice a guy, too soft-spoken and well mannered to really play the star. At one opening, Shire remembers, Agle got waylaid in the parking lot by 40 or 50 autograph seekers. He only made it inside after Shire told the crowd, "This has got to stop."
"He can't say no," Shire says.
The Agle home, built in 1962 by an unknown designer, has a touch of Japan and a fair bit of Tiki—at the entrance and in the studio, and with the 380-plus Tiki mugs displayed between the living and dining areas. There's a rail pole from the original Don the Beachcomber Tiki restaurant and one from Pongo Pongo in Arizona. The pool and waterfalls, however, are Tiki free.
Agle may be doing well—but he's not quite where he wants to be. Being identified with lowbrow art doesn't bother him.
Lowbrow art tends to be more illustrational than what passes today for fine art—more attuned to hot rods, Bettie Page, and grinning devils. "It's become a little bit more proletariat" than fine art, Shire says, less enslaved to the "arts establishment saying what is good and what people should like." He adds: "These people now are buying it [lowbrow art] because they like it."
"I don't have a problem with the term lowbrow," Agle says. "Most of the artists do have a problem with that. They think it's demeaning."
Besides showing in galleries in many cities—including Los Angeles and Palm Springs, New York, Seattle, and Tokyo—he has had a one-man exhibit at the Laguna Art Museum.
Still, it is annoying that not everyone takes what Agle does seriously.
Some of his newer work is growing larger in size and theme, with more figures, and more going on. "They're a little more surreal and decadent than I've been in the past," he says.
"Real fine artists with blue-chip galleries, that's where every artist wants to be. Every artist wants to hear that his painting has sold for $5 million at Sotheby's," Agle says.
But for now, he says, "I love painting. I love being a painter. And that's what I want to do."
Photos: John Eng, Adriene Biondo; and courtesy Lee Joseph (of Dionysus Records) and Josh Agle
All Shag paintings courtesy Josh Agle
• To find a gallery carrying Shag paintings, check his website, shag.com. For prints, go to shagmart.com. Shag's next book of art, 'Autumn's Come Undone' (Baby Tattoo Press), is due out in September 2009. It features a series of large-scale paintings that, says Shag, "will be darker and more personal than anything I've done in the past." Also don't miss 'Shag: the Art of Josh Agle' (Chronicle Books).


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Pottery & Porcelain Marks – Words & Initials – N: "Niloak" is a mark used by an Arkansas pottery. They spelled "Kaolin," the special white clay used to make porcelain, backwards. You can find other marks starting with "N" here too.
Enter your email below to receive Kovels Komments for the latest antiques & collectibles news, answers to readers questions, marks and tips. In your inbox every Wednesday.
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Guest Post & Photo by Stephan Bollinger Circle Stephan on Google+
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Let my words, dear friends, be treasures. Weightless golden butterflies that hang before your eyes for seconds, then are gone. But the dust of truth and beauty that their wingbeats leave behind will settle on your soul and make you happy. - Edward Monkton
Fly High
Spin Hard
Don't Stop
'We're all mad here. I'm mad, you're mad." [said the Cat.]
"How do you know I'm mad?" said Alice.
"You must be," said the Cat, "Or you wouldn't have come here."
- Lewis Carroll, Alice's Adventures In Wonderland
Fly High
Spin Hard
Don't Stop


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I would disagree with "most" although I will agree that 'some' fit that description...unfortunately those few do get the majority of the press so I believe it severely distorts the perception.
Most kids today exhibit no motivation, cannot self entertain themselves and when they do, it is usually criminal in nature. Sad.


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|Method of making partially crystalline biaxially oriented hollow plastic heat set containers
|Ajmera et al.
|Method for manufacturing heat resistant PET containers
|Denis et al.
|Process of forming a biaxially oriented thermoplastic tube including the formation and severance of a bubble forming a radially outwardly flared leading tube end
|Reed et al.
|Apparatus for moulding an article from plastic material
|Jakobsen et al.
|Balloon and manufacture thereof
|Method of forming a pipe of oriented thermoplastics polymeric material
|Riley et al.
|Method for producing a tubular object of polyethylene terephthalate or similar thermoplastic material from a tubular blank of amorphous material
|Process for the production of a blank for subsequent shaping by blow-molding
|Jakobsen et al.
|Method of making endotracheal tube cuffs
|Method of two-step blow molding employing a transfer clamp
|Dybala et al.
|Method of forming plastic containers
|Miller et al.
|Method of blow-moulding a biaxially oriented polyethylene terephthalate resin bottle-shaped container.
|January, 1984
|November, 1984
This is a divisional, of copending application Ser. No. 561,840, filed aug. 2, 1990, now U.S. Pat. No. 5,055,024, which is a continuation of application Ser. No. 452,715, filed Dec. 19, 1989, now U.S. Pat. No. 5,017,325, which is a divisional of application Ser. No. 384,418, filed Jul. 24, 1989, now U.S. Pat. No. 4,938,676, which is a continuation-in-part of application Ser. No. 253,070, filed Oct. 4, 1989 now abandoned.
feeding an elongated tubularly shaped parison into and through a molding apparatus including an upstream chamber and a downstream blow molding chamber until one portion of the parison is in the upstream chamber and another portion of the parison is in the downstream blow molding chamber;
axially stretching to longitudinally elongate at least the portion of the parison within the upstream chamber to provide an axially elongated parison length;
radially expanding the axially elongated parison length within the upstream chamber by infusing pressurized fluid thereinto to provide a radially expanded parison length;
axially stretching at least the portion of the radially expanded parison length until its diameter is decreased while moving the radially expanded parison length into the downstream chamber; and
blow molding the radially expanded and axially stretched parison length by infusing pressurized fluid thereinto while same is within the downstream blow molding chamber to provide a molded parison useful as a medical device balloon.
feeding an elongated tubularly shaped parison through a molding apparatus including a free-blow chamber and a downstream blow molding chamber;
longitudinally stretching the parison within the free-blow chamber to provide an axially stretched parison length;
radially expanding the axially stretched parison length by infusing pressurized fluid thereinto while same is within the free-blow chamber to provide a radially expanded parison length;
axially stretching the radially expanded parison length;
blow molding the radially expanded and axially stretched parison length, said blow molding step including raising the temperature of the radially expanded and axially stretched parison within the downstream blow molding chamber and infusing the pressurized fluid into a portion of the elongated parison that is upstream of the free-blow chamber whereby the pressurized fluid flows through the parison within the free-blow chamber and then into the radially expanded and axially stretched parison within the downstream blow molding chamber;
closing off the parison between the free-blow chamber and the blow molding chamber to prevent passage of pressurized fluid therebetween, and radially expanding the axially stretched parison at an elevated temperature within the free-blow chamber to form another radially expanded parison length; and
axially stretching said another radially expanded parison length, following by blow molding same within the blow molding chamber at an elevated temperature to provide a molded parison useful as a medical device balloon.
The present invention generally relates to apparatus and methods for manufacturing balloons for medical devices. More particularly, the invention relates to the manufacture of medical or surgical balloons and to catheters incorporating them, such as those designed for angioplasty, valvuloplasty and urological uses and the like. The balloons exhibit the ability to be tailored to have expansion properties which are desired for a particular end use. The expansion property of particular interest is the amount or percentage of expansion or stretching beyond a non-distended inflated size at which the balloons are inflated to remove folding wrinkles but are not stretched. Balloons which are especially suitable in this regard are made of nylon or polyamide tubing that has been biaxially oriented or formed into the desired balloon configuration.
Catheter balloons and medical devices incorporating them are well-known for use in surgical contexts such as angioplasty procedures and other medical procedures during which narrowings or obstructions in blood vessels and other body passageways are altered in order to increase blood flow through the obstructed area of the blood vessel. For example, in a typical balloon angioplasty procedure, a partially occluded blood vessel lumen is enlarged through the use of a balloon catheter that is passed percutaneously by way of the arterial system to the site of the vascular obstruction. The balloon is then inflated to dilate the vessel lumen at the site of the obstruction.
Essentially, a balloon catheter is a thin, flexible length of tubing having a small inflatable balloon at a desired location along its length, such as at or near its tip. Balloon catheters are designed to be inserted into a body passageway such as the lumen of a blood vessel, a heart passageway, a urological passageway and the like, typically with fluoroscopic guidance.
In the past, medical device balloon materials have included balloons having a wall thickness at which the material exhibits strength and flexibility that allow inflation to a working diameter or designated initial dilation diameter which, once achieved, is not surpassable to any significant degree without balloon breakage or substantially increasing the risk of balloon breakage. Balloons of these materials can be characterized as being substantially non-distensible balloons that are not stretchable, expandable or compliant to a substantial extent beyond this working diameter. Such substantially non-distensible balloons can be characterized as being somewhat in the nature of paper bags which, once inflated to generally remove folding wrinkles, do not further inflate to any significant degree. Polymeric materials of this substantially non-distensible type that are used or proposed for use as medical balloons include polyethylene terephthalates.
Other types of materials, such as polyvinyl chlorides and cross-linked polyethylenes can be characterized as being distensible in that they grow in volume or stretch with increasing pressure until they break. These materials are generally elastic and/or stretchable. When such extensible materials are used as medical balloons, the working diameter or designated dilation diameter of the balloon can be exceeded, based upon the stretchability of the material.
Substantially non-distensible balloons have at times been considered to be advantageous because they will not inflate significantly beyond their respective designated dilation diameters, thereby minimizing possible over-inflation errors. The theory is that one need only select a balloon such as an angiographic balloon that has an opened and inflated diameter which substantially corresponds to the dilation size desired at the obstruction site. However, physiological vessels such as arteries are generally tapered and do not always coincide with readily available catheter balloon dimensions, and at times it may be preferable to be able to increase the diameter of the balloon beyond what had been initially anticipated. With a substantially non-distensible balloon, such further extension is severely limited. On the other hand, certain non-distensible materials out of which medical balloons are made generally possess relatively high tensile strength values, which is typically a desirable attribute, especially for dilating tough lesions.
More readily distensible materials such as polyvinyl chloride typically exhibit a lower tensile strength and a larger elongation than a substantially non-distensible material such as polyethylene terephthalate. This relatively low tensile strength increases the risk of possible balloon failure. Due to their larger ultimate elongation, most readily distensible materials can provide a wide range of effective inflation or dilation diameters for each particular balloon size because the inflated working profile of the balloon, once achieved, can be further expanded in order to effect addition dilation. But this very property of having an expanded dilation range is not without its dangers because of the increased risk of overinflation that can damage the blood vessel being treated, and the overinflation risk may have to be compensated for by using balloon wall thicknesses greater than might otherwise be desired.
Although a material such as polyethylene terephthalate is advantageous from the point of view of its especially high tensile strength and its tightly controllable inflation characteristics, it has undesirable properties in addition to its general non-distensibility. In some situations, biaxial orientation of polyethylene terephthalate will impart excessive crystallinity to an angioplasty balloon, or the Young's modulus will be simply too high. Under these circumstances, the balloon itself or the thicker leg sections thereof will not readily fold over and down in order to provide the type of low profile that is desirable for insertion through a guiding catheter and/or through the cardiovascular system and especially through the narrowed artery which is to be dilated. The resistance to folding, or "winging," is an especially difficult problem when it comes to larger balloons, such as those intended for valvuloplasty applications.
Also, it has been observed that thin-walled materials such a polyethylene terephthalate have a tendency to form pin holes or exhibit other signs of weakening, especially when flexed. Such a tendency can require extreme care in handling so as to avoid inadvertent damage that could substantially weaken a polyethylene terephthalate medical balloon. Although it is known that a lower profile and more flexible balloon and balloon legs can be made by thinning the wall, thus thinned polyethylene terephthalate balloons become extremely fragile and may not survive insertion through the cardiovascular system with desired integrity and without pin-holding and/or rupture.
Materials such as polyethylene terephthalate do not readily accept coating with drugs or lubricants, which can be desirable in many applications. Polyethylene terephthalate materials are also difficult to fuse, whether by adherence by heating or with known biocompatible adhesives.
By the present invention, these undesirable and/or disadvantageous properties of substantially non-distensible medical balloons such as those made from polyethylene terephthalate materials are significantly eliminated. At the same time, many of the advantages of these types of materials are provided or approximated. Furthermore, the present invention realizes many of the advantages of the more elastomeric materials such as polyvinyl chloride, but without the disadvantages of relatively low tensile strength, and the possibility of excessive expandibility that can lead to overinflation of a blood vessel or the like.
In summary, the present invention achieves these objectives and provides advantageous properties along these lines by forming and providing a catheter and medical catheter balloon constructed of a material that is of limited and generally controlled distensibility whereby expansion beyond the working or fully expanded but non-distended dilation profile of the balloon is possible, but only to a desired extent which can, within limits, be tailored to the particular needs of the balloon device. The invention includes utilizing a tailorable material such as a nylon material or a polyamide material that is formed within the molding apparatus into a biaxially oriented balloon by appropriate axial elongation, radial expansion and heat treatment procedures.
It is a general object of the present invention to provide an improved apparatus and methods for molding a medical balloon.
Another object of the present invention is to provide an improved apparatus and methods for forming medical balloons that exhibit controlled distensibility at high pressure.
Another object of the present invention is to provide an improved apparatus and methods for forming medial balloons which provide a range of dilation capabilities while minimizing risks that could be associated with such flexibility.
Another object of the present invention is to provide an improved angioplasty catheter balloon molding method and apparatus that are especially suitable for forming tubing of tailorable materials such as nylon or polyamide into catheter balloons.
Another object of the present invention is to provide an improved means and method for biaxially orienting relatively amorphorous tubing into biaxially oriented medical balloons.
Another object of the present invention is to provide an improved apparatus and method for forming a balloon catheter that is readily coated with materials such as lubricating agents and the like which are advantageous for administration in association with balloon catheters.
Another object of this invention is to provide an improved apparatus and method for forming a balloon that exhibits a combination of good strength and desirable flexibility.
Another object of this invention is to provide an improved apparatus and method for forming a medical balloon that exhibits an ability to be readily fused to other components.
These and other objects, features and advantages of this invention will be clearly understood through a consideration of the following detailed description.
In the course of this description, reference will be made to the attached drawings, wherein:
FIG. 1 is an elevational illustration, partially in cross-section, of a balloon catheter having a structure typical of that suitable for angioplasty;
FIGS. 2a, 2b, 2c, 2d and 2e are elevational illustrations of tubing as it is progressively processed to transform same into a medical balloon according to the invention;
FIG. 3 is a cross-sectional view illustrating a preferred apparatus for carrying out the processing steps illustrated in FIGS. 2a, 2b, 2c, 2d and 2e;
FIG. 4 is a plot of balloon size versus balloon inflation pressure for balloons made of a variety of materials, including nylon balloons tailored to provide different radial expansion properties;
FIGS. 5 and 6 are plots illustrating the function of heat setting on tailorability; and
FIG. 7 is a plot illustrating the function of hoop expansion ratio on tailorability.
An illustrative catheter is generally designated in FIG. 1 by reference numeral 21. Catheter 21 includes a catheter tube 22 having a proximal end 23 and a distal end 24. A guiding catheter 25 is also illustrated. A medical balloon 26 is shown secured to the distal portion of the catheter tube 22 in a location overlying one or more apertures 27 through the catheter tube. Extending through the lumen of the catheter tube 22 is an inner elongated body 28, such having a proximal and 29 and a distal tip end 31. The inner body 28 may be solid or have an internal lumen, depending upon the function that the inner body is to perform, whether it be simply a guiding function or whether it is intended to also provide the capability to insert materials into the bloodstream or measure parameters of the bloodstream, or the like.
Except for the balloon 26, all of these various components perform functions that are generally appreciated in the art. Typically with the aid of the guiding catheter 25, the inner body 28 and the catheter tube 22 are inserted into the cardiovascular system until the balloon is located at an occlusion site. At this stage, the balloon 26 is typically folded and collapsed, and it has an external diameter less than the inflated diameter illustrated in FIG. 1, to the extent that the balloon 26 is generally wrapped around the catheter tube 22. Once the balloon 26 is maneuvered to the location of the occlusion, a pressurized fluid is inserted at the proximal end 23 of the catheter tube 22 for passage through aperture 27 and for inflation of the balloon 26. This unfolds the balloon until it presents a relatively smooth outer surface or working profile for imparting forces that are radially outwardly directed at the desired site within the body in order to achieve the desired result of lesion dilation, occlusion reduction or similar treatment. In accordance with an important aspect of the invention, the passage of greater pressure against the inside surface of the balloon 26 permits the outer surface of the balloon 26 t transmit additional force to the lesion or the like, which may include actual further radially outwardly directed movement of the balloon 26 beyond its working profile, as illustrated in phantom in FIG. 1.
FIGS. 2a, 2b, 2c, 2d and 2e illustrate the transformation of a length of tubing 32 that is a material such as extruded nylon or polyamide into a biaxially oriented balloon 33 or a modified biaxially oriented balloon 34. Either balloon 33 or 34 possesses the ability to be first inflated to its unextended or working profile and then therebeyond to a limit and/or controlled extent by the application of greater pressure. Each balloon 33 and 34 includes a balloon portion 35, 36, respectively, and leg portions 37, 38, respectively. The leg portions 37, 38 are the portions of the balloon that are secured to the tube 22 of the catheter 21.
In an exemplary application, tubing length 32 is extruded so that it exhibits a diameter that is roughly one-quarter of the diameter intended for the balloon. The extruded tubing length 32 also has a nominal wall thickness that is on the order of six to twelve or so times the desired wall thickness of the balloon 33, 34.
FIG. 2b illustrates tubing length 32a, which is tubing length 32, after it has been elongated to approximately three times its original length. This elongation or drawing procedure is carried out at approximately room temperature, and same proceeds typically until it has been stretched to the point that it exhibits a noticeable resistance to further stretching. Typically, the pull force is greater than the yield point of the particular tubing length 32, but less than the ultimate tensile strength, lengthwise, of the selected material. Generally speaking, this axial elongation procedure is carried out until the wall thickness of the tubing length 32a is roughly one-half of the wall thickness of the tubing length 32 and/or until the diameter of the tubing length 32 a is roughly one-half to forty percent of the outer diameter of the tubing length 32. The actual stretched length can typically be about two times to about four times or more of the original tubing length 32. Actual stretching of the tubing 32 can be performed by simply axially stretching length 32 or by pulling or drawing length 32 through a sizing die.
FIG. 2c illustrates a step that is carried out after the longitudinal orientation procedure of FIG. 2b has been completed. This is a biaxially orientation step by which a portion of the tubing length 32a expands primarily radially and thereby delineates the balloon portion 35 from the leg portions 37. This biaxial orientation is carried out by pressure exerted on the inside wall of the tubing length 32a by a pressurized fluid. Typically, the balloon portion 35 will have an outer diameter that is on the order of roughly si times the outer diameter of the tubing length 32a. The pressurized fluid may include gasses such as compound air, nitrogen or argon. Liquids such as water or alcohol could also be used if they do not pose a problem of leaving residual fluid in the balloon. Generally speaking, the larger the balloon, the faster will be the inflation fluid flow rate. Examples of cardiac balloons generally ranked in typical order of increasing size are those designed for use in coronary arteries, those designed for use in peripheral arteries, and valvuloplasty balloons for use in cardiac valves. Other balloons include uroplasty balloons for dilating the prostatic urethra.
The procedure illustrated in FIG. 2c can be facilitated by controlling the location at which the radial expansion will occur. An advantageous manner of effecting this result is to carry out a local application of heat to the balloon portion 35 during radial expansion while avoiding such heat application at the leg portion 37. Elevating the temperature in such a localized area will lower the yield point of the nylon, polyamide or the like at that location and thereby facilitate the radial expansion of this selected area. As an example, a temperature for conducting this step typically can be between about 35° C. and perhaps a high as 90° C. the optimum temperature depending somewhat upon the particular material that is utilized.
Means are provided for controlling the expansion of the tubing length 32a and its formation into the balloon portion 35 and the legs 37. This can be accomplished by controlling and monitoring conditions and/or expansion positions within a molding apparatus. An exemplary means in this regard is included in the molding apparatus describe herein. Otherwise, this function can be accomplished by closely controlling the rate of fluid passage and by monitoring the pressure thereof. For example, for a valvuloplasty balloon, the following approach can be taken. One end of the longitudinally elongated tube having a diameter of approximately 0.140 inch and a wall thickness of approximately 0.006 inch is sealed, and a liquid such as water is pumped into the tube at a rate of approximately 2 ml per minute. For tubing of this size and at a flow rate of this magnitude, balloon inflation begins at about 300 psi gauge and drops to around 150 psi gauge. Expansion continues in this manner until the wall of a mold bearing the desired shape of the balloon is encountered, which is observable by a significant pressure increase. Pumping continues until a pressure of about 180 to 200 psi is reached. This pressure condition can be held or maintained, if desired.
A satisfactory balloon can be prepared by proceeding with the method through and including the step illustrated in FIG. 2c, followed by dimensional stabilization, heat setting or thermoforming, the balloon to near its radially expanded profile and size by maintaining its elevated temperature until the selected material is thermally set. Tailorability that is achieved according to this invention is a function of the particular heat setting conditions. The setting temperature can vary with the type of material used, the wall thickness, and the treatment time. A typical setting temperature is between about 100° C. and about 160° C. for a nylon material, and a typical time is from about 1 minutes to about 4 minutes.
Such balloons 33 may include expansion knurls 39 that tend to appear in the areas generally extending between the legs 37 and the working surface of the balloon portion 35. These expansion knurls, which may be described as nodules, ridges, ribs, beads or the like, are believed to result from disproportionate expansion of the material such as nylon in this area. When it is desired to minimize the existence of these expansion knurls 39 on the balloon, secondary longitudinal elongation with radial shrinkage followed by secondary radial expansion can proceed with a balloon that is not thermally set, such being illustrated in FIG. 2d and FIG. 2e.
Regarding FIG. 2d, the balloon 33 of FIG. 2c, which is not thermally set, is again longitudinally elongated by applying an axially directed force that is typically greater than the yield point but less than the ultimate tensile strength of the balloon 33. This may be carried out at approximately room temperature. If desired, the magnitude of this axial force can be substantially the same as the magnitude of the axial force applied in the procedure illustrated in FIG. 2b. Further biaxial orientation is then conducted by, for example, introducing a pressurized fluid into the balloon lumen in order to prepare the balloon 34 shown in FIG. 2e. It is often desirable to conduct his procedure within a mold cavity in order to thereby effect a careful shaping of the balloon portion 36, the leg portions 38, and the tapered connection surfaces therebetween, generally as desired. The resulting modified balloon 34 typically will not include any significant expansion knurls 39, and it will exhibit a uniform transition between the balloon portion 36 and the leg portions 38.
Whether the procedure is utilized that forms the balloon 33 or if the procedure is continued such that the balloon 34 is formed, the thus formed balloon 33, 34 is preferably then subjected to a hat setting step at which the still pressurized balloon 33, 34 is heated to set the expanded dimensions thereof. Setting will typically be accomplished at a temperature of 85° C. or greater, typically up to about the melting point of the balloon material, depending somewhat upon the actual material and the size and thickness of the balloon. For example, a typical heat setting temperature for Nylon 12 is 1 minute at 120° C. With this heat treatment, the balloon will retain this form and most of its expanded size, typically about 95% of more of it, upon being cooled. Preferably, the balloon remains pressurized until it is generally cooled. If this heat setting procedure is not utilized, the balloon will promptly shrink back to approximately 40% to 50% of the diameter to which it had been blown or biaxially oriented in the mold.
With more particular reference to this heat setting procedure, an important component in this regard is the use of a thermoformable material. A material is thermoformed if it can be formed to another shape. Nylon is a thermoforming plastic. It can be heated to a temperature below its melting point and deformed or formed to take on another shape and/or size. When cooled, thermoforming materials retain that new shape and/or size. This procedure is substantially repeatable. On the other hand, a thermosetting material, such as a natural latex rubber, a crosslinked polyethylene or a silicone rubber, once "set" is crosslinked into that size and/or shape and cannot be heat deformed. Also, biaxially oriented polyethylene terephthalate tends to crystallize and lose the thermoforming ability that is typical of polyethylene terephthalate which is not biaxially oriented. When a biaxially oriented nylon balloon, as discussed herein is heated for a prolonged period of time at temperatures greater than a predetermined elevated temperature, for example about 80° C., and then cooled, it becomes thermoformed to the balloon geometry. If the balloon were to be reheated to this temperature or above, it could be formed into a balloon having a different geometry.
FIG. 3 illustrates a molding apparatus that is suitable for fabricating medical balloons as discussed herein. The apparatus transforms a parison 41 into balloons for medical devices and the like. The apparatus achieves longitudinal stretching, radial expansion or biaxial orientation, heating and cooling, and it includes means for monitoring radial expansion, all of which can be conveniently controlled by suitable means such a hard circuitry, a microprocessor, or other computerized controlling arrangement. These various parameters that are controlled can thus be precisely set and easily modified in order to present the optimum conditions for fabricating a particular parison into a balloon having a specified sizing and the properties desired. Specific parameter values are presented herein which are typically suitable for balloon materials such as nylons, and it will be understood that these parameter values can be modified as needed for the specific material being shaped into the balloon.
The apparatus that is illustrated also has the ability to generally simultaneously perform different steps on multiple balloon portions of the parison 41 as it passes through the apparatus. This can be especially useful because of variations in wall thickness and other attributes of each batch of tubing that is used as the parison 41.
The apparatus includes a series of components which are suitably mounted with respect to each other, such as along slide rails 4. From time to time, movement of some of the components along the rails or the like is carried out by suitable means, such as piston assemblies (not shown) in accordance with generally known principles and structures.
A pressurized fluid supply 43 is provided to direct pressurized fluid into an end portion of the parison 41, typically in conjunction with one or more regulators 44 in accordance with well-known principles. One or more valves 45 also assist in controlling the flow rate and volume of pressurized fluid within the parison 41. Gripper assemblies 46 and 47 are provided for engaging different locations of the parison 41. An intermediate gripper assembly 48 is preferably also provided. One or more chiller chambers 51, 52, 53, 54 are also preferably provided. These are particularly useful as means for thermally isolating assemblies of the apparatus from each other. Also included are a free-blow radial expansion chamber or mold 55 and a molding chamber 56.
Preferably, means are provided by which the temperature of these various chambers is controlled and/or varied, for example between about 0° C. and about 150° C. or more. The illustrated assembly in this regard includes a jacket for confining a thermal fluid that is pumped thereinto and out thereof by suitable fluid inlets 57 and fluid outlets 58. O-rings 59 or the like are provided in order to contain the thermal fluid within each fluid jacket 61, 62, 63, 64, 65, 66.
In using the illustrating apparatus, the parison 41 is initially fed or threaded through the entire apparatus, typically between gripper assembly 46 and gripper assembly 47. Gripping pads 68 of the gripper assembly 47 move inwardly and engage the downstream end portion of the parison 41 to the extent that it pinches off this portion of the parison 41, preferably also heat sealing the parison at this time. Generally simultaneously, gripping pads 67 of the gripper assembly 46 engage the parison 41 at the illustrated upstream location of the apparatus to such an extent that the gripping pads 67 will prevent movement of the parison 41 with respect to the gripping pads 67, but still permit the flow of pressurized fluid thereacross when desired. Gripper assembly 47 then moves in a downstream direction (to the right as illustrated in FIG. 3) until the length of the parison that is secured between gripper assemblies 46 and 47 is stretched in excess of twice its length up to as greater as about four times its length or more, a typical stretching being approximately three times this unstretched length.
Next, the free-blow radial expansion chamber 55 is heated by passing heated thermal fluid into the fluid jacket 62. The chiller chambers 51, 52, or other suitable means, provide a thermal variant such that the heat from the fluid jacket 62 is imparted only to that length of the parison that is substantially within the free-blow chamber 55. The temperature of this particular portion of the parison 41 will be heated above ambient temperature, for example to a temperature at least slightly above ambient such as between 30° C. and 60° C., preferably to a temperature of roughly between about 70° C. and 150° C. or more, depending upon the particular parison 41 and the balloon properties desired. At this time, pressurized fluid within the parison 41 that originates from the supply 43 passes through the parison length at the gripper assembly 46 and into the parison length at the free-blow chamber 55. If desired, the gripper assembly 48 can be utilized in order to confine this particular pressure application to the section of the parison 41 that is upstream thereof.
A primary objective of the free-blow chamber 55 is to radially expand that portion of the parison 41 into a balloon 33 as generally illustrated in FIG. 2c. It is often desired to precisely control the amount of radial expansion, and means in this regard are provided. The means illustrated in FIG. 3 includes a slidable insert or ring 69. When tis insert 69 is engaged by the expanding balloon 33, it moves against an air or metallic spring (not shown) in a direction to the left as illustrated in FIG. 3 until it trips a suitable switch or the like (not shown), which signals that the desired degree of radial expansion has been achieved. At this time, steps are taken to interrupt the radial expansion. This typically includes cooling by exchanging the heated thermal fluid within the fluid jacket 62 for thermal fluid having a colder temperature, typically on the order of about 10° C. or somewhat above or below depending upon the particular parison 41 and the particular properties desired. For example, the temperature of the chamber 55 can be reduced to about room temperature or lower.
The pressure imparted to balloon portion 33 is then depleted by, for example, permitting exhaustion thereof through the vale 45 after the balloon has been cooled. If utilized, the griper assembly 48 is released, and the balloon portion 43 is moved from the free-blow chamber 55 into the molding chamber 56 by movement of the downstream end portion of the parison by the gripper assembly 47. This typically simultaneously accomplishes the longitudinal orientation stage depicted in FIG. 2d. Once this positioning takes place, the pressurized fluid is pumped into that portion of the parison that is within the molding chamber 56, and thermal fluid is passed into the fluid jacket 65 in order to heat this portion of the parison to an elevated temperature, again between about 70° C. and up to just below the melting point, for example 150° C. or more, depending upon the particular parison and the properties desired of the balloon.
Generally speaking, it is usually advantageous that the temperature in the molding chamber 56 be higher than that applied in the free-blow chamber 55, while at the same time imparting a pressure to the inside walls of the parison within the molding chamber 56 that is equal to or lower than the pressure applied in the free-blow chamber 55. For example, when a nylon is the material, the temperature in the free-blow chamber 55 can be slightly above ambient, preferably in a range of between about 30° C. and 60° C., while the temperature in the molding chamber 56 can be at the high end of this range or even well above, as needed. Exemplary pressures would include on the order of ten atmospheres in the molding chamber 56 and twice that pressure or greater in the free-blow chamber 55. The exact pressure is determined by the material and by the wall thickness and hoop stress of the balloon to be molded.
With heat thus imparted to the modified balloon 34 within the molding chamber 56, the balloon 34 is thereby thermoformed, with heat setting in this regard involving raising the temperature of the thermoplastic while it is under inflated stress. Thereafter, the heated fluid within the fluid jacket 65 is exchanged for cooling fluid in order to substantially maintain the size and shape of the balloon 34 formed within the molding chamber 56. After the pressure has been relieved, the balloon is removed from the apparatus. Subsequently, the thus modified portion is severed generally along lines A and B is illustrated in FIG. 2e in order to thereby form the balloon 26 for inclusion within a medical device such as the catheter 21.
It will be appreciated that the parison will include balloons in various stages of their formation as the parison passes through the apparatus. Preferably, this is accomplished in a somewhat reverse manner, as follows. After initial stretching and formation of a balloon 33 within the free-blow chamber 55, the apparatus is utilized so that the portion of the parison within the molding chamber 56 is radially expanded before that within the free-blow chamber 55, which generally occurs as follows. Molding chamber 56 is heated as described herein and pressurized to form the balloon 34. Thereafter, the gripper assembly 48 closes off the parison between the chambers 55 and 56 to substantially prevent passage of pressurized fluid therebetween. The free-blow chamber 55 is then heated, and the radial expansion is carried out a described herein in order to from the balloon 33. Balloon 33 is then moved into the molding chamber 56, and the process is essentially repeated.
It should be appreciated that the balloon can be made entirely in the mold section 56 without free blowing in compartment 55. However, balloons made in this manner may demonstrate knurling.
Regarding the fluids suitable for use in the apparatus, it is typically advantageous to have the pressure source 43 provide a fluid that does not require excessive treatment to remove same from the internal surfaces of the finished medical device balloon 26. To be taken into consideration in this regard are moisture content of fluids and ease and safety of disposal of the fluid. A particularly suitable fluid is pressurized nitrogen gas. With respect to the fluid for use within the various fluid jackets 61 through 66, it is typically best to utilize a fluid that is in its liquid state throughout whatever processing temperatures might be need for the apparatus. Preferably the fluid is one that will likewise maintain a generally consistent viscosity throughout the processing range, for example, avoiding the onset of solidification or crystal formation or the like that would modify the properties of the thermal fluid at lower processing temperatures.
With respect to the materials out of which the balloon and parison are made, they are typically nylons or polyamides. Preferably, these materials have an amorphous nature while still possessing enough crystallinity to be biaxially oriented or formed under the conditions provided according to this invention. The materials should also have substantial tensile strength, be resistant to pin-holing even after folding and unfolding, and be generally scratch resistant. The material should have an intrinsic viscosity that enables blowing at elevated temperatures. A typical intrinsic viscosity range that is preferred for the nylon or polyamide materials according to this invention is between about 0.8 and 1.5, with about 1.3 being especially preferred. It is also desired that the material have a reasonably good moisture resistance. Materials of the Nylon 12 type have been found to possess these advantageous properties. Other exemplary nylons include Nylon 11, Nylon 9, Nylon 69 and Nylon 66.
With more particular reference to the intrinsic viscosity of nylon or polyamide materials, it is believed that such materials are able to generally maintain their intrinsic viscosities during extrusion and through to final balloon fabrication. It is further understood that other materials such as polyethylene terephthalate which have been used to fabricate balloons for medical devices typically do not exhibit this viscosity of the pellet material drops substantially during extrusion, with the result that a biaxially oriented polyethylene terephthalate balloon is understood to have an intrinsic viscosity which is lower than that of the polyethylene terephthalate pellets from which it originated. It is further believed that a higher balloon intrinsic viscosity reduces the likelihood that pin-holing will develop in the finally fabricated balloon.
With further reference to the nylon or polyamide materials which may be used according to this invention, they are bondable to the catheter 21 by epoxy adhesives, urethane adhesives, cyanoacrylates, and other adhesives suitable for bonding nylon or the like, as well as by hot melt bonding, ultrasonic welding, heat fusion and the like. Furthermore, these balloons may be attached to the catheter by mechanical means such as swage locks, crimp fittings, threads and the like. Nylon or polyamide material can also be provided in the form in which they are reinforced with linear materials such as Kevlar and ultra high tensile strength polyethylenes. The polymer materials used can also be coated with pharmaceutical materials such a heparin and the like, non-thrombogenic lubricants such as polyvinyl pyrrolidone and the like. Additionally, the polymer materials can be filled with radiopaque media such as barium sulfate, bismuth subcarbonate, iodine containing molecules, tungsten, or other fillers such as plasticizers, extrusion lubricants, pigments, antioxidants and the like.
Nylons or polyamides as used according to the present invention are flexible enough to tolerate a greater wall thickness, even in the leg areas, while still providing a structure that is foldable onto itself for insertion into a body cavity or guiding catheter. These nylons or polyamides, when formed into balloons as discussed herein, have a calculated tensile strength of between about 15,000 and about 35,000 psi and above, preferably between about 20,000 and about 32,000 psi.
The materials according to the present invention form medical device balloons that exhibit the ability to be expanded first to a non-stretched or non-distended condition, or working size, upon the application of a given pressure. They also have the ability to be inflated further so as to be stretched therebeyond in a controlled and limited manner. The degree of such stretching or expansion can, within limits, be tailored as needed. In other words, the balloons according to the present invention allow for some growth at a pressure higher than that needed to merely fill the balloon, but this additional growth or expansion is not so substantial that there is an overinflation danger.
Materials according to this invention should be able to be tailored during balloon formation to possess the ability to be stretched a generally predetermined percentage beyond its non-distended or working diameter, the amount of this percentage depending upon conditions under which the parison was processed into the balloon. A suitable material according to the present invention ca be tailored to cover values within a span of at least 10 percentage points of radial expansion. Certain materials including some nylons can exhibit a tailorability range of 25 or 30 percentage points or more and can, for example, exhibit a radial expansion of 10 percent or below and as high as about 30 percent or above.
In order to illustrate this situation, tests were run on angioplasty balloons of different materials, namely polyvinyl chloride, cross-linked polyethylene, polyethylene terephthalate and nylon. These data are reported graphically in FIG. 4. Wall thickness varied depending upon the properties of the material in order to provide a viable balloon. The polyethylene terephthalate balloon (B) had a wall thickness of 0.010 mm. The polyvinyl chloride balloon (C) had a wall thickness of 0.064 mm, and the polyethylene balloon (D) had a wall thickness of 0.058 mm. (Data for balloons C and D are as reported in "Effects of Inflation Pressure on Coronary Angioplasty Balloons," The American Journal of Cardiology, Jan. 1, 1986, these tests being run under ambient conditions, while the remaining balloons in FIG. 4 were tested at 37° C.) One of the nylon balloons (A) had a wall thickness of 0.013 mm and a hoop expansion ratio of 5.2. Another of the nylon balloons (E) had a wall thickness of 0.008 mm and a hoop expansion ratio of 4.3. Tailorability of balloons according to this invention is a function of hoop expansion ratio, which is defined as mean balloon diameter divided by means as-extruded tubing or parison diameter.
FIG. 4 plots the relative pressure of the fluid imparted to the various angiographic catheters against the percentage increase in size (such as diameter or radius) of the balloon beyond its working size, designated as "0." It will be noted that the more compliant materials, such as polyvinyl chloride, gradually grow with increased pressure and permit some limited additional pressure increase after the working size has been achieved and before further expansion ceases prior to reaching the burst limit of the balloon. It will be appreciated that, with materials such as these, a smaller increase (when compared with materials of plots A and B) in relative pressure significantly increases the balloon size. Materials such as polyethylene terephthalate (PET) inflate to their working size, but not therebeyond to an extent as great as others of the plotted curves.
The nylon or polyamide material illustrated by curve E exhibits a relatively long and flat curve in FIG. 4, which indicates that it will continue to expand moderately upon the application of relatively small additional increments of inflation pressure. Once the unstretched or non-distended profile of working size is reached, this tailored nylon balloon possesses adequate stretchability or compliance to the extent that it can ramp up to another inflated profile. While the polyethylene balloon of curve D initially distends to about the same extent as does the nylon curve E balloon, this nylon balloon can tolerate greater inflation pressures without bursting than can the curve D polyethylene balloon or the curve C polyvinyl chloride balloon. This observation is especially significant when it is appreciated that the curve E nylon balloon had a substantially thinner wall diameter. Based upon data such as that illustrated in FIG. 4, it is possible to predict the compliant expansion associated with added inflation pressure. A balloon in accordance with the present invention can exhibit this growth property so that it will radially expand from a low of about 5 percent beyond the working size to a high of about 35 percent or more of the working size.
As previously observed herein, balloon expansion tailorability is a function of heat setting conditions and of hoop expansion ratio for balloon materials according to the present invention. For such materials, increasing the heat set temperature increases the size of the finished balloon at a given inflation pressure and decreases the shrinkage which typically occurs after sterilization such as a standard ethylene oxide treatment. Also, the amount of hoop expansion imparted to the parison during processing has a significant effect on the amount of distention which the finished balloon will exhibit.
FIGS. 5 and 6 illustrate the effect of varying heat setting conditions on the distensibility of the finished balloon. This heat setting is achieved when the balloon is subjected to a temperature greater than the glass transition temperature of the balloon material and is allowed to cool to below the glass transition temperature. For a material such as a nylon or a polyamide, temperatures between about 90°0 C. and about 180° C. have a pronounced heat setting capability. The glass transition temperature may be less than this heat setting temperature and may include temperatures in the range of 20° C. to about 40° C., and the balloon will exhibit good flexibility at body temperature which can, for example, facilitate balloon insertion and maneuverability during use.
FIG. 5 gives four distention plots, tested at 37° C. for nylon balloons that are substantially identical except they were subjected to different heat set temperatures. In each case, the balloon was subjected to a 2 minute heat/cool cycle, with cooling being to room temperature. Each balloon was subsequently subjected to ethylene oxide sterilization. Curve F was subjected to a heat set temperature of 120° C., curve G was at 130° C., curve H was at 140° C., and curve I was at 150° C. It will be noted that the curves illustrate different distention properties and the type of tailoring thus achieved. FIG. 6 provides a similar illustration and further shows an effect of the ethylene oxide sterilization. While curves J and K both are for balloons which were heat set at 100° C., the curve J balloon was sterilized while the curve K balloon was not. Likewise, the balloons of curves L and M both were heat set at 140° C., curve L illustrating a sterilized situation, and curve M a non-sterilized situation.
The relationship between balloon tailorability and hoop expansion ratio is illustrated in FIG. 7. Three non-sterilized nylon balloons having different hoop expansion ratios were tested at 37° C., the expansion being to burst. A relatively high hoop expansion ratio of 4.9 (curve N) gave a balloon distention (safely short of burst) of about 7 percent. A 3.7 hoop expansion ratio (curve O) gave a balloon distention of about 23 percent, while a 3.3 hoop expansion ratio (curve P) gave a balloon distention of about 36 percent.
Furthermore, nylon or polyamide balloons according to the present invention provide controlled expansion properties and tolerate given pressure without bursting without requiring wall thicknesses as great as those needed for other materials such as polyvinyl chloride or polyethylene. This thin wall thickness of these nylon balloons permits the balloon to enter smaller vessels, lesions and/or catheters. Suitable balloons according to this invention can have shell or wall thicknesses as low as about 0.0002 inch and as high as 0.002 inch. An exemplary preferred shell thickness range is between about 0.0004 and about 0.001 inch, or between about 0.0005 and about 0.0008 inch.
A material such as nylon is softer and more flexible at body temperature, the temperature at which it is used, than other balloon materials such as polyethylene terephthalate which have a glass transition temperature far in excess of body temperature. For at least some nylons, the glass transition temperature approximates body temperature, and nylon balloons generally exhibit amorphous properties that enhance flexibility and softness even after proceeding with the type of processing described herein, including thermoforming and the like. Nylon balloons thus can be at a glass transition state while they are within the body, which is not the case for numerous other materials that can be used as medical balloons.
Balloons made of nylons exhibit a property such that, when they burst, the diameter of the balloon will increase, thereby facilitating removal from the body. It is believed this decrease may be caused by a relaxing of the material which noticeably reduces the size of the balloon. Other materials such as polyethylene terephthalate are not known to exhibit this advantageous property. A disadvantageous property that can be characteristic of polyethylene terephthalate medical balloons is the development of extensive material wrinkling upon sterilization, which wrinkles persist, even at body temperature, until very high inflation pressures are applied, on the order of 200 psi. When a nylon or polyamide balloon is sterilized, few if any material wrinkles develop, and these substantially disappear at relatively low inflation pressures, on the order of 8 psi.
Nylon materials have been observed to exhibit desirable stability during processing to the extent that they do not absorb excessive moisture from the environment if the parison is allowed to stand uncovered for reasonable time periods. Materials such as polyethylene terephthalate are degraded by environment moisture if the parison is not stored in protective bags or the like prior to biaxial orientation.
It will be understood that the embodiments of the present invention which have been described are illustrative of some of the applications of the principles of the present invention. Numerous modifications may be made by those skilled in the art without departing from the true spirit and scope of the invention.