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Swiss police arrest 6 soccer officials at request of US authorities ahead...
Defending champ Sharapova sets up third-round match with 2010 finalist...
Canadian Olympian Jessica Smith looking to cement place on team for Pan Am...
1. Pick the right spot
When it comes to gardens, it's...
Another of a monthly series of articles on genealogy, written by members of...
PETERBOROUGH — Memo to Jim Russell: There is a world beyond the Rotary...
Residents are being reminded to keep an eye on their family pets after an increase of coyote sightings in the area.
Such reports certainly aren't surprising in a rural community such as Brock Township, but one Cannington resident saw one prowling a few hundred metres from the village's downtown a few weeks ago.
Coyotes "have adapted well to urban environments and they're commonly found in rural and urban areas," said Ron Allen, the Ministry of Natural Resource's acting area supervisor for the York/Durham area of the Aurora district.
"Even in urban areas there are natural areas like river valleys that provide wildlife habitat."
In most cases, wild animals such as coyotes move into populated areas for either shelter or more likely for food, explained Mr. Allen.
The best solution, he added, is to remove "attractants" such as garbage by properly storing or securing waste.
"By removing attractants, you can solve almost all human-wildlife conflicts," he said.
The MNR also suggested pet owners keep their animals inside at night and prohibit them from roaming the neighbourhood,
Durham is the worst-hit region in Ontario in terms of coyote attacks, according to a provincial program that compensates farmers for livestock lost to predators.
Durham farmers received $168,000 for 545 dead or injured animals in the 2008-09 season.
Most were sheep and cattle, but poultry and goats were also attacked.
There doesn't appear to be a biological reason for the situation, said John Pisapio, a biologist with the Ministry of Natural Resources. But, Durham Region has traditionally seen a higher-than-normal incidence of such attacks.
"Biologically, it's very difficult to provide any explanation for that," Mr. Pisapio said.
"There aren't any more coyotes (than elsewhere), there's not any more of a prey base, there's not that much more livestock."
A Toronto Star story earlier this year blamed many of the area attacks on "coywolfs" -- an emerging species resulting from wolves and coyotes interbreeding.
The larger, highly adaptable animals "have the wolf characteristics of pack hunting and aggression and the coyote characteristics of lack of fear of human-developed areas," says Trent University geneticist Bradley White, who's been studying the hybrids for 12 years.
It's "evolution in action," he said.
They report attacks by animals that are bigger, bolder and smarter than regular coyotes. They say hunting in packs to prey on sheep and cattle in broad daylight is becoming a common behaviour.
Commonly called eastern coyotes, the creatures are actually a mixture of western coyote and eastern wolf that comes from a constantly evolving gene pool, Mr. White told the Star.
But as coywolves become more urbanized and their relationship with people continues to evolve, city dwellers can expect problems, Mr. White said, suggesting a control program may be needed at some point.
The MNR has more information available on its web site including what the public can do to protect themselves and their pets and what to do if you meet a coyote.
For more information, visit www.mnr.gov.on.ca, go to the Wildlife Management Section, click on Living with Wildlife and then go to the section titled Coyotes in the Community.
With notes from Toronto Star, Durham Region Media Group
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The Homesick Pie
Previously: The Get-On-Our-Level Pie
Ann Friedman is 5,437 miles from Los Angeles.
Previously: The Get-On-Our-Level Pie
Ann Friedman is 5,437 miles from Los Angeles.
Ann Friedman vows to start 'gramming photos of herself hunched over a laptop.
Previously: The Pushy Pie
Ann Friedman will probably not exercise double next week.
Previously: The Huge Mistake Pie
Ann Friedman owns three Steely albums on vinyl, which is really the only way to hear them.
Previously: The Hobby Lobby Pie
Ann Friedman needs the GOP to understand where she's at.
Previously: The Harsh Mellow Pie
Ann Friedman runneth over.
Previously: The Stylish Housewife Pie
Ann Friedman is a humane editor with great ambitions.
Ann Friedman is covered in glitter and shaking with rage.
Previously: The Sedentary Pie
Ann Friedman is just high enough.
Previously: The Dad Vibes Pie
Ann Friedman does not have four children, a devoted husband, or a higher calling.

subset: commoncrawl


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Philips SBCMD195 Microphone - 50 Hz to 15 kHz - Wired - 16.40 ft - Dynamic - Handheld - Mini-phone - SBCMD 195
Learn more about Philips SBCMD195 Microphone - 50 Hz to 15 kHz - Wired - 16.40 ft - Dynamic - Handheld - Mini-phone:
Volume Control
A durable microphone with reduced handling noise to liven up every singing and entertainment occasion.
Customer Reviews of Philips SBCMD195 Microphone - 50 Hz to 15 kHz - Wired - 16.40 ft - Dynamic - Handheld - Mini-phone
Great buy!9/3/2014
Very nice premium microphone for the same price as a brand x version on Ebay...definitely a great value!!!
Philips Mini phone9/3/2014
good product
Great beginner microphone.7/18/2014
Plugged it in and it just works.
Good product6/26/2014
Well satisfied. I bought these microphones for a karaoke machine, and they work as well as the originals.
Great product5/27/2014
It is a great product and worth with the price. I am very happy with it.
it good choice for the Philips products5/22/2014
Very good quality. I dont think it low price but get the good brand for that. Thanks
Very Happy4/14/2014
I was very happy that the item came exactly the way it was advertised and delivered on time. My son was very excited when he received his microphone to go with his amp. Thanks.
great mic for the money12/24/2013
Been looking for a cheap well functional mic for quite a while. This one definitely fits that bill
Philips volume control microphone12/24/2013
I didn't need the volume control of the microphone, but it's okay to be there. Nice sound quality and thinner cord is great. Also the provided 1/4" adapter works well.
microphone ok12/3/2013
seems to work fine, just need to have correct gain set on PC
Finally a decent microphone11/22/2013
I have tried several microphones but none provided good sound recording. This one finally works. It is solid and delivers a good recording. I like the ability to control the recording level at the mic.
Nice Affordable Mic11/22/2013
Good overall quality.. sound level adjustment is handy.
View all buying options for Philips SBCMD195 Microphone - 50 Hz to 15 kHz - Wired - 16.40 ft - Dynamic - Handheld - Mini-phone
100% Brand New and Free shipping
Shipping: Usually ships in 1 to 2 business days
Condition: Brand New
About the Seller
Seller Description
Marketplace Guarantee ClaimBuyers should receive Marketplace items in the condition that they were listed. We ask buyers to first contact the seller to give them a chance to address any issues. If the seller does not respond or if the issue is not addressed to the customer's satisfaction buyers can rely on our Rakuten.com Marketplace Guarantee Claim which, covers the first $750 of every purchase... read more
Returns Policy
We have a 7 day Customer Satisfaction Guarantee return policy, which offers a refund less shipping on all goods returned within 7 days upon receipt of package. We ship all goods via FedEx. If the recipient is not available to sign after the 3rd delivery attempt, the package is then retur...read more


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Welcoming a New Jewelry Designer
A few weeks ago, I had an email from a new jewelry designer. She enjoys working on projects like Leslee Frumin's right-angle weave necklace, Puttin' on the Ritz. (Her version is pictured at left; instructions are in Beadwork February/March 2007). She also enjoys making her own designs and wants to start selling her work. After I emailed her with some advice, she wrote back to let me know that she had to put her business website on hold because of . . . algebra.
Did I mention she's 12?
One of the wonderful things about working in a creative field like beading is that your age doesn't matter nearly as much as the quality of your work. Part of my advice to Becca was to not let other people tell her she was "too young" to start following her dreams. What advice or encouraging words do you have for her, or other new designers? Please share your wisdom in the comments section, so we can all enjoy and learn!
Bead Crochet and Wire Necklace from Step by Step Wire Jewelry
Harvest Gold Necklaceby Judy ZedalisThis fall-inspired project combines wirework and bead crochet in autumn colors of amber, gold, black, and brown. Even if you aren't interested in bead crochet, you might take a look at some of the wireworking features (like the coils pictured at right) and try incorporating those into a design.
Check out the Winter 2008 issue of Step by Step Wire Jewelry for great projects like wire embellished beads, 4-in-1 chain maille earrings, a pearl cuff bracelet, and a flowing collar necklace by Dale "Cougar" Armstrong that will challenge advanced wireworkers. View the full table of contents
4 Jewelry Business Tips
Coming Next Week: Holiday-related projects to kick off your gift-making season.
Today's the last day to answer the current poll question: Have you ever sold a beaded item you've made?
Story Update: The instructions for the o-ring necklace by the Sleepless Beader (see the photo in Monday's post) will be published in the March/April 2008 issue of Step by Step Beads.
Michelle Mach is the editor of Beading Daily. She is going to start on her holiday beading this weekend!
© 2015 F+W All rights reserved.Use of this site signifies your agreement to the Terms and Privacy Policy, updated March 2007


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Unfortunately Celestron 8x42 Outland LX Roof Prisms Waterproof Binoculars 71104 is no longer carried by OpticsPlanet. You can also explore other items in the Binoculars category yourself to try and find the perfect replacement for you!
This model of Celestron Binoculars is discontinued and no longer available. Please choose from our wide selection of Meade Binoculars, Bushnell Binoculars, and other Binoculars on our site.


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No major surprises through Week 1 at Aussie Open
MELBOURNE, Australia Nearly a week into the Australian Open, the only major surprise is that there have been, well, not many surprises at all.
The year's first Grand Slam is historically fraught with injury withdrawals or top players not yet up to speed in the new season and losing in the first few rounds.
But with the third round complete for the leading players at Melbourne Park, only one of the first eight men's seeds did not advance: No. 6 Juan Martin del Potro. Six of the eight top women were through.
Second-seeded Roger Federer was the last of the main contenders to advance to the fourth round, beating Australian Bernard Tomic 6-4, 7-6 (5), 6-1. Federer trailed 4-1 in the tiebreaker but rallied for six of the next seven points in front of a full house at the 15,000-seat Rod Laver Arena.
"I had a few more chances than he did, but I thought the tiebreaker was going to go his way," said Federer. "I think overall we played a great match, he really got the best out of me tonight."
The four-time Australian Open champion will next play big-serving Canadian Milos Raonic, who beat No. 17 Philipp Kohlschreiber of Germany 7-6 (4), 6-3, 6-4.
Del Potro was a 6-3, 6-3, 6-7 (3), 3-6, 6-3 loser to France's Jeremy Chardy earlier Saturday in the biggest upset so far in this tournament.
Those still around have advanced fairly impressively.
Top-seeded Novak Djokovic and No. 3 Andy Murray haven't dropped a set in three matches, although Murray had his difficult moments in Saturday's 6-3, 6-4, 7-5 win over Lithuanian qualifier and sometimes hitting partner Ricardas Berankis, while fourth-seeded David Ferrer has lost just one set.
"I was struggling, he was making me feel pretty uncomfortable on the court," Murray said.
Chardy broke 2009 U.S. Open champion del Potro's serve in the final set to go up 5-3, then served out the match in 3 hours, 45 minutes.
"I played some tennis I never would have thought I was capable of playing," Chardy said.
Seventh-seeded Jo-Wilfried Tsonga beat Slovenian Blaz Kavcic 6-2, 6-1, 6-4 and will meet countryman Richard Gasquet, who beat Croatian Ivan Dodig 4-6, 6-3, 7-6 (2), 6-0.
Andrea Seppi of Italy beat Croatia's Marin Cilic 6-7 (2), 6-3, 2-6, 6-4, 6-2 to also advance to the fourth round.
In women's play, top-seeded Victoria Azarenka had her problems against injury-affected American Jamie Hampton and needed three sets to advance on Saturday, but No. 3 Serena Williams has not dropped a set despite an injured right ankle.
"There's always two ways - your opponent plays good and you can also make your opponent look good," Azarenka said after her 6-4, 4-6. 6-2 win.
Williams, aiming for a third consecutive major title, recovered from a break down in the second set to win six straight games and beat Japan's Ayumi Morita 6-1, 6-3. She later combined with older sister Venus to win a second-round doubles match.
Williams surprised herself with another serve at 128 mph in an afternoon match in Rod Laver Arena, matching a career best that she hit earlier in the tournament.


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I'm sure that everyone has heard the news, but if not, here are the details:
Magic Your Way Package with Free Disney Dining Plan
Booking Window: 7/12 9/29/12
Travel Window: 9/3010/4, 10/1911/1, 11/911/15, 11/2311/29 and 12/1012/13/12
Buy a non-discounted 6-Night/7-Day Magic Your Way Package at select Disney Value Resorts and get a FREEQuick-Service Dining Plan, or at select Disney Moderate, Deluxe and Deluxe Villa Resorts and get a FREE DisneyDining Plan.
You have to purchase a three-night minimum stay with the package to get the free dining. These deals go pretty quickly, so give us a call or email if you want a free, no-obligation quote!
Jeff and George are both Authorized Disney Vacation Planners with Fairy Godmother Travel.
They are happy to provide free, no-obligation quotes to Walt Disney World, Disneyland, Disney Cruise Line, Adventures By Disney and Aulani.
Feel free to email them or call them. If you are interested in a package with Free Dining, they will need the following information:
- First and Last Name of each person in the party
- Age of each child at time of travel
- Address
- Telephone Number
- Dates of Travel
Jeff can be reached at [email protected] or 723-278-7404
George can be reached at [email protected] or 336-287-8114
Fairy Godmother Travel


text:
Search Results for slr camera
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Pentax FA Series Film SLR Camera Lenses
The Pentax FA Series Film SLR Camera Lenses was developed to be the ideally suited product ... quality products for countless years, and the Pentax FA Series Film SLR Camera Lenses is the proof ... with the ideally suited item for your needs, and the Pentax FA Series Film SLR Camera Lenses is amongst ... the astounding Pentax FA Series Film SLR Camera Lenses. To have an awesome way to verify that you are using ... and depth of field control. Developed for PENTAX film SLR cameras, however full-frame optics are also ... compatible with PENTAX digital SLR cameras. PENTAX's exclusive FREE (Fixed Rear Element Extension) ... for anyone looking for a high quality option. These DSLR Camera Lenses through the skilled product experts...
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Pentax D FA Series Film and Digital SLR Camera Lenses
We are proud to have Pentax D FA Series Digital SLR Camera Lenses available to you at a discount ... SLR cameras as well. These Pentax digital camera accessories utilize lens coatings, curvature ... images with digital SLR cameras. Available Options for Pentax D-FA Series Macro SLR Camera Lenses ... Series Digital SLR Camera Lens For more Digital Camera Accessories by Pentax such as neck straps, ... price. We are an Authorized US Distributor for Pentax Digital Camera Accessories. All camera ... accessories by Pentax from our online store comes with a Full Manufacturer Warranty. The D FA series camera ... lenses, are compatible with all Pentax 35mm film cameras, but built specifically for Pentax Digital...
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Pentax DA Star High Grade DSLR Camera Lenses w/ SDM Focus System
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The staff was extremely friendly and helpful. The pool was refreshing and sparkling. Very nice on a hot day.
A few things did not work but the staff was very responsive.
This hotel was a 2 minute walk to the beach.
room was small and the hotel did not seem to be family friendly
Liked the location near a beach. Room had new furnishings, convenient walk to breakfast and comfortable bed.
Noisey air conditioner. Top sheet was too short.
Perfect location.
The bed. I didn't sleep well, since the bed was very firm. But, that's a matter of opinion. My fiancé loved the bed, (he's a firm mattress person).
The motel was very clean, and the location was convenient for us. It's also walking distance to an uncrowded beach. The owner is very nice and helpful, and makes good coffee.
No, everything was fine!
Location and ocean view room.
Service in restaurant for breakfast was extremely slow.
Love the staff from time we waled til the time we left. They made us feel like family.
Not a Thing
Location on the Cape, distance from home, (about 1.5 hour drive)
No, the staff was friendly, the facility was clean and welcoming, and we will visit again.
The bar and Kevin the bar tender. He was very nice.
The location. Actually I was looking to stay close to beach.
The location was perfect! We were 100' from Nantucket Sound, there's nothing like hearing the waves all night! The staff was pleasant and helpful. The pool was brisk in September, not sure if it's 'heated', but it was nice nonetheless with very little chlorine smell. There were mostly mature couples when we were there, school having already started. The bath was in need of a bit of TLC but not bad by any stretch. My husband was chatting with the owner and we were both impressed with his vision for the place. All in all it was a great stay which I have already recommended to friends. .
They are NOT green! Nowhere to recycle. The front desk said housekeeping would take care of any recyclables I left behind, so hopefully they really did and didn't just pitch them!
Breakfast was wonderful and the colors chosen for the rooms were calming
Most everything else. It was very very noisy. There was no fridge no table, a broken wicker chair. No antibacterial hand soap. The floors were beyond filthy. I went searching for a swiffer it was that bad. The outlet behind the bed is a major fire hazard as it has been damaged and had no cover and anytime someone slammed their door the light plugged their would flicker. When anyone entered the building our door would bust open unless locked and when locked would rattle loudly. The pool was ice cold. And the beach was disgusting. Literally there was not a soul on it yet the public beach was packed
clean and update.
We got to the hotel, and there was a sign in the window stating 'be right back". We called the # on the sign and was told the manager was on the way.
We were told we couldn't get in early as all rooms were booked. And then were told to find the maid and she can show us a room.
There was not a car in the lot.
We looked at the room and it was horrible. We did not stay..
The pool was filled with green slime..
We called Booking.com and they are helping us
What a dump..
We ended up staying at a nice hotel in another town.
Please review your listings, as this place is 0 stars..
met our needs and the price was right
needs some repairs
Very well kept facility, some condos are a bit dated but well maintained and clean. On-site Restaurants all very good for both breakfast and dinner.
Here's why:
We're not the seller
At KAYAK we don't set prices, so it's not possible for us to guarantee what other companies are selling.
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text:
Special Correspondent
HYDERABAD: Union Labour Minister K. Chandrasekhar Rao has criticised the State Government for its alleged indifference towards distressed poultry farmers.
Referring to the crisis the industry passed through in the wake of bird flu, Mr. Rao said at a press conference here on Friday that the problem had a cascading effect across sectors impacting State's economy. But the Government had failed to respond to the situation. Mr. Rao said that he would take up relief measures for farmers with the Prime Minister and raise the issue in next meeting of the Union Cabinet.
More In: ANDHRA PRADESH | NATIONAL


text:
The investment seeks long-term growth of capital.
The fund invests primarily in common stocks of foreign companies of any size, including companies that are economically tied to developed and emerging industrialized markets. It will normally invest in a number of countries throughout the world and expects to be investing in more than three different foreign countries. The fund follows a disciplined selling strategy and may sell a stock when it reaches a target price, fails to perform as expected, or when other opportunities appear more attractive. It may also engage in borrowing and securities lending transactions and use derivatives.
[1] http://www.globalfunddata.com/funds/new/performance/management?variant=Transamerica
[2] http://www.globalfunddata.com/funds/new/performance/domicile?variant=United States
[3] http://www.globalfunddata.com/funds/new/performance/fund_administrator?variant=Transamerica Fund Services Inc
[4] http://www.globalfunddata.com/funds/new/performance/strategy?variant=Foreign Large Blend
[5] http://www.globalfunddata.com/funds/new/performance/structure?variant=Open Ended Investment Company
[6] http://www.globalfunddata.com/funds/new/performance/city?variant=St Petersburg___United States
[7] http://www.globalfunddata.com/funds/new/performance/country?variant=United States
[8] http://www.globalfunddata.com/funds/new/performance/custodian?variant=State Street Bank & Trust Co
[9] mailto:firstname.lastname@example.com?subject=Mail from GFM Ltd


text:
Faced with a huge fiscal deficit and rising costs of social security programmes, the United Progressive Alliance-II government could announce possible decontrol of petrol and diesel prices in the Union budget to be presented by Finance Minister Pranab Mukherjee on February 26.
This could provide the road map for partial deregulation of the petroleum sector and help it cut down on subsidies. Official sources in the Petroleum Ministry said both Mr. Mukherjee and the Petroleum and Natural Gas Minister Murli Deora discussed such a road map that could ultimately provide an alternative to the oil marketing companies (OMCs) to review the prices of petrol and diesel on a regular basis.
"There is a strong view in the Ministries, that notwithstanding the opposition within the UPA, it is high time that petrol and diesel are totally decontrolled and left to market forces to decide the ups and downs in their price movement. LPG and kerosene could continue to be administered by the government," the sources said.
Mr. Mukherjee is learnt to have told Mr. Deora that it would not be possible to provide huge subsidies to the OMCs in future, especially in view of the commitment of the UPA regime to flagship social security programmes that require huge allocations. "The Finance Ministry is in favour of decontrolling auto fuel prices to limit the government's subsidy. A decision is expected to be announced shortly, but most likely will find mention in the Budget," the sources said.
The two sides discussed a proposal to put in place a regime that would allow the OMCs to review or revisit petrol and diesel prices every 30 days based on average international price of the last one month. It was felt that the current low international crude oil prices provided the best opportunity to usher in reforms without consumers feeling the pinch. As such, it was pointed out that motor vehicles were the biggest consumers of diesel, at 12 to 14 per cent, compared to the agriculture sector, at 10 per cent.
Keywords: Fuel prices, petrol, diesel, decntrol, budget, Pranab Mukherjee


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Jason Berry is a handyman who offers residential remodeling and home improvement services. He also does plumbing, porch, interior painting, rewiring, mold remediation and refinishing, among others.
5/5 stars 55 reviews · 6 credentials
This business specializes in providing home improvement and building services. They do interior or exterior painting, kitchen and bathroom remodeling, demolition, furniture refinishing, and more.
4/5 stars 11 reviews · 3 credentials · Licensed in NY
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text:
The secretary of homeland security, Janet Napolitano, said Monday that the thwarted bombing of a Detroit-bound airliner represented a failure of the nation's aviation security system, not the success she and other administration officials had portrayed in comments over the weekend. via Security System Failed, Napolitano Acknowledges – NYTimes.com.
Security System Failed, Napolitano Acknowledges – NYTimes.com
December 28, 2009 by Leave a Comment
Security reviews under way after airliner attack – AP
December 27, 2009 by Leave a Comment
Investigators piecing together a brazen attempt to bring down a trans-Atlantic airliner said Sunday the suspect tucked a small bag holding his deadly concoction on his body, using an explosive that would have been easily detected with the right airport equipment. His success in smuggling and partially igniting the material on Friday's flight to Detroit […]


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Cheap MLI to Napakiak flights
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text:
Ayaan Hirsi Ali debates whether Islam is a religion of peace, wins in a rout
- By David KennerDavid Kenner is the Middle East editor for Foreign Policy.
- david.kenner
- @davidkenner
Intelligence Squared hosted some intellectual heavyweights on Oct. 6 to debate the motion: "Is Islam a religion of peace." Those who took part included Maajid Nawaz, the founder of the counter-extremism Quilliam Foundation, who argued in favor of the resolution, and Ayaan Hirsi Ali, the former Dutch MP and critic of Islam, who argued against it.
The result? Hirsi Ali won in a landslide. Intelligence Squared polled the audience before and after the debate, and she prevailed over almost all of the undecided audience members and even a segment of those who had previously disagreed with her. Here's the hard data:
Before the debate:
After the debate:
This will be painted as a chilling sign of the rise of Western anti-Islam bigotry, but I'm not so sure that's clear. Obviously, Islam isn't a "peaceful" religion any more than, say, Christianity, Judaism, or Hinduism. If the audience was only convinced that the violent tendencies in Islam are on par with those religions, that does not necessarily mean that they're all about to become fans of Geert Wilders. If anyone had asked my vote, I would have told them that it's a stupid question.
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U.S. Defense Secretary Panetta Visits Afghanistan
Images similairesAfficher tout
U.S. Defense Secretary Leon Panetta looks at the 3rd Infantry... Photo d'actualitéAfghanistan,Arrivée,Aéroport,Aéroport de Kandahar,Conflit,Diplomatie,Horizontal,Infanterie,Kandahar,Leon E. Panetta,Mascotte,Politique,Regarder,Rocher,États-UnisPhotographer PoolCollection: Getty Images News 2012 Getty ImagesKANDAHAR, AFGHANISTAN - DECEMBER 13: U.S. Defense Secretary Leon Panetta looks at the 3rd Infantry Division mascot, Rocky the Bulldog, with Army Maj. Gen. Robert Abrams, (R) after Panetta arrived at Kandahar Airfield on December 13, 2013 Kandahar, Afghanistan. Secretary Panetta is meeting with Afghan president Hamid Karzai and top Afghan officials as the the U.S. look towards a desicion on troop numbers once the U.S. led coalition ends in late 2014. (Photo by Susan Walsh - Pool/Getty Images)


text:
Winter!: Prepare for holiday gaming!
Legendary class based, team objective multiplayer. Inspired maps, balanced gameplay. Not newbie friendly. It is a very skill oriented game. In my opinion, it is the best online multiplayer ever made. The sequel isn't as good, but it was free...
Game Traits applied to Return to Castle Wolfenstein (PC) by Dimension
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text:
An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. A device includes a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid.
1. A device for intradermally delivering a substance through at least one layer of the skin of a subject, the device comprising:
a substantially circular shaped body having a top face, a bottom face spaced from the top face, and a side edge, the body having a channel, wherein the bottom face includes at least one raised conical frustum shaped protrusion disposed on the bottom face having a skin abutment surface;
at least one dermal-access member being provided in each of the at least one raised conical frustum shaped protrusion and in fluid communication with the channel, wherein the at least one dermal-access member extends from about 0.3 mm to about 3 mm from the skin abutment surface;
a fitting wherein the fitting is operatively and fluidically coupled to a fluid delivery system selected from the group consisting of syringe, pump, and medication delivery pen; and
a tubing having a lumen and a first end and second end, wherein the first end is attached to the top face of the body, wherein the lumen of the tubing in fluid communication with the channel, and the second end of the tubing is connected to the fitting, and the lumen of the tubing is in fluid communication with the fitting.
2. The device of
3. The device of
4. The device of
5. The device of
6. The device of
7. The device of
8. The device of
9. The device of
10. The device of
11. The device of
12. The device of
13. The device of
14. The device of
15. The device of
16. The device of
17. A method of delivering a substance through at least one layer of the skin of a subject, the method comprising the steps of:
providing a device having a substantially circular shaped body having a top face, a bottom face spaced from the top face, and a side edge having a flange, the body having a channel, wherein the bottom face includes at least one raised conical frustum shaped protrusion disposed on the bottom face having a skin abutment surface;
at least one dermal-access member being provided in each of the at least one raised conical frustum shaped protrusion and in fluid communication with the channel, wherein the at least one dermal-access member extends from about 0.3 mm to about 3 mm from the skin abutment surface wherein the channel is fluidically coupled to a fluid delivery system selected from the group consisting of syringe, pump, and medication delivery pen;
positioning the at least one dermal-access member on a target site of the skin of the subject;
applying a pressure against the device sufficient for the at least one dermal-access member to penetrate the skin and for the skin abutment surface to contact the skin; and
delivering a substance to the target site of the subject.
18. The method of
19. The method of
20. The method of
21. A device for intradermally delivering a substance from a fluid delivery system through at least one layer of the skin of a subject, the device comprising:
a body having a top face, a bottom face spaced from the top face, and a side edge, the body defining a channel and the body being adapted to be disposed proximate to the subject's skin;
a flange extending outwardly from the side edge of the body and adapted to be grasped by a caregiver;
a raised protrusion disposed on the bottom face, wherein the raised protrusion has a conical frustum shape that defines a skin abutment surface;
a needle extending from the body a fixed distance, wherein the needle is disposed proximate to but at a selected distance from the skin abutment surface of the raised protrusion, wherein the needle has an inner diameter that is in fluid communication with the channel and wherein the needle extends between about 1.0 mm to about 1.7 mm beyond the skin abutment surface;
a fitting is adapted to be operatively and fluidically coupled to the fluid delivery system; and
a flexible tubing defining a lumen and having a first end and second end, wherein the first end is engaged to the body such that the lumen of the tubing is in fluid communication with the channel, and the second end of the tubing is connected to the fitting such that the lumen is in fluid communication with the fitting, wherein the tubing has a larger internal diameter than the needles.
22. The device of
23. The device of
24. The device of
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26. The device of
27. The device of
28. The device of
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31. The device of
The present application is a continuation of U.S. patent Application Ser. No. 10/951,208 filed on Sep. 27, 2004 which is a continuation of U.S. patent application Ser. No. 10/357,502 filed on Feb. 4, 2003, now U.S. Pat. No. 6,808,506 on Oct. 26, 2004 which claimed priority to the following U.S. Provisional Patent Applications, identified by application No. and filing date: No. 60/353,194, filed Feb. 4, 2002; No. 60/397,038, filed Jul. 22, 2002; No. 60/407,284, filed Sep. 3, 2002; No. 60/420,233, filed Oct. 23, 2002; No. 60/377,649 filed May 6, 2002; and No. 60/389,881, filed Jun. 20, 2002. This application is also related to U.S. application Ser. No. 10/951,217, filed Sep. 27, 2004, which has issued as U.S. Pat. No. 7,083,592 on Aug. 1, 2006. The contents of each of the foregoing documents are incorporated herein by reference in their entirety.
1. Field of the Invention
The present invention relates to a device and a method for delivering or withdrawing a substance through the skin of an animal, including humans, and in particular to a method and device for withdrawing or delivering a substance such as a drug, protein or vaccine to a subject. The invention also relates to a device for enhancing the penetration of one or more dermal-access members.
2. Related Art
The skin is made up of several layers with the upper composite layer being the epithelial layer. The outermost layer of the skin is the stratum corneum that has well known barrier properties to prevent molecules and various substances from entering the body and analytes from exiting the body. The stratum corneum is a complex structure of compacted keratinized cell remnants having a thickness of about 10-30 microns. The stratum corneum forms a waterproof membrane to protect the body from invasion by various substances and the outward migration of various compounds.
The natural impermeability of the stratum corneum prevents the administration of most pharmaceutical agents and other substances through the skin. Numerous methods and devices have been proposed to enhance the permeability of the skin and to increase the diffusion of various substances through the skin in order to be utilized by the body. According to some methods and devices, the delivery of substances through the skin is enhanced by either increasing the permeability of the skin or increasing the force or energy used to direct the substance through the skin.
Other methods of sampling and delivering various substances through the skin include forming micropores or cuts through the stratum corneum. Numerous substances can be effectively administered by piercing the stratum corneum and delivering a substance in or below the stratum corneum. In a similar manner, some substances can be extracted from the body through cuts or pores formed in the stratum corneum. The devices for piercing the stratum corneum generally include a plurality of microneedles or blades having a length to pierce the stratum corneum. Examples of these devices are disclosed in U.S. Pat. No. 5,879,326 to Godshall et al.; U.S. Pat. No. 6,494,865 to Alchas; U.S. Pat. No. 5,997,501 to Gross et al.; U.S. Pat. No. 4,886,499 to Cirelli et al.; U.S. Pat. No. 6,183,434 to Eppstein; U.S. Pat. No. 5,250,023 to Lee et al.; International publication WO 97/48440; U.S. Pat. No. 5,527,288 to Gross et al.; and U.S. Pat. No. 3,595,231 to Pistor. Each of the foregoing documents is incorporated herein by reference in their entirety.
Some of the above-noted devices include micron-sized needles or blades and can be effective in delivering or sampling substances. However, many of these needles and blades have a length of a few microns to a few hundred microns and typically do not penetrate the skin to a uniform depth. The natural elasticity and resilience of the skin often result in the skin being deformed by the needles rather than pierced. Therefore, when a microneedle array is pressed against the skin, the outermost needles penetrate the skin while the innermost needles do not penetrate the skin or only penetrate to a depth less than the outermost needles.
Moreover, conventional devices have problems with overall height and ease of use. As a result, the prior methods and devices for the sampling and administering of substances have exhibited limited success. Accordingly, a continuing need exists in the industry for an improved device for the sampling and administering of various substances to the body.
These and other objects are accomplished by a method and device according to the present invention.
A device for delivering or withdrawing a substance, typically a fluid, below the stratum corneum is provided. A body of the device includes a top face, a bottom face spaced from the top face, and a side edge. Typically, a channel is defined within the body. The bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. At least one dermal-access member is provided in each raised protrusion and is in fluid communication with the channel to deliver or withdraw the substance.
Similarly, a method of delivering or withdrawing a substance through at least one layer of the skin of a subject is provided. The method includes the steps of: providing a device having a body having a top face, a bottom face spaced from the top face, and a side edge, the body defining a channel within the body, and at least one dermal-access member coupled to and extending outwardly from the bottom face and being in fluid communication with the channel, wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area, the bottom face further including at least one raised protrusion disposed on the second surface area, at least one dermal-access member installed in at least one raised protrusion; positioning the dermal-access member on a target site of the skin of the subject; applying a pressure against the device sufficient for at least one dermal-access member to penetrate the skin and for the first surface area to contact the skin; and delivering a substance to or withdrawing a substance from the target side of the subject.
In particular, a method and apparatus for delivering a substance, such as a drug, protein or vaccine, into or below the stratum corneum of the skin to a sufficient depth where the substance can be absorbed and utilized by the body is provided.
The device and method according to an embodiment of the present invention are suitable for use in administering various substances, including pharmaceutical and bioactive agents, to a subject, preferably a mammal, and particularly to a human patient. Such substances have biological activity and can be delivered through the body membranes and surfaces, and particularly the skin. Examples include, but are not limited to antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, and the like. Additional substances that can be delivered to a subject include proteins, peptides and fragments thereof. The proteins and peptides can be naturally occurring, synthesized or produced by recombination.
The device and method may also be used for withdrawing a substance or monitoring the level of a substance in the body. Examples of substances that can be monitored or withdrawn include blood, interstitial fluid or plasma. The withdrawn substances may then be analyzed for various components or properties.
The dermal-access member according to the invention is any member which penetrates the skin of a subject to the desired targeted depth within a predetermined space without passing through it. In most cases, the device will penetrate the skin to a depth of about 0.3-3 mm. Generally, the device is utilized for intradermal administration, for example, with a configuration sufficient to penetrate at a depth of about 1.0-1.7 mm. However, the device can also be used to deliver a substance to a depth of about 0.3 mm or less and at subcutaneous depths of 1.7 mm-3.0 mm depths or greater.
The dermal-access members may comprise conventional injection needles, catheters or microneedles of all known types, employed singularly or in multiple member arrays. The terms "dermal-access member" and "dermal-access members" as used herein are intended to encompass all such needle-like structures. The dermal-access members can include structures smaller than about 28 gauge, typically about 29-50 gauge when such structures are cylindrical in nature. Generally, the dermal access members will be about 30-36 gauge. Non-cylindrical structures encompassed by the term dermal-access member would therefore be of comparable diameter and include pyramidal, rectangular, octagonal, wedged, triangular, hexagonal, cylindrical, tapered and other geometrical shapes and arrangements. For example, the dermal-access members can be microtubes, lancets and the like. Any suitable delivery mechanism can be provided for delivering the substance to the penetrated skin.
By varying the targeted depth of delivery of substances by the dermal-access members, pharmacokinetic and pharmacodynamic (PK/PD) behavior of the drug or substance can be tailored to the desired clinical application most appropriate for a particular patient's condition. The targeted depth of delivery of substances by the dermal-access members may be controlled manually by the practitioner, with or without the assistance of an indicator mechanism to indicate when the desired depth is reached. Preferably however, the device has structural mechanisms for controlling skin penetration to the desired depth. This is most typically accomplished by means of a widened area or hub associated with the shaft of the dermal-access member that may take the form of a backing structure or platform to which the dermal-access members are attached. The length of dermal-access members may be varied during the fabrication process and can be produced at less than 3 mm in length. The dermal-access members are typically sharp and of a very small gauge, to further reduce pain and other sensation when the dermal-access members are seated in the patient. The invention may include a single-lumen dermal-access member or multiple dermal-access members assembled or fabricated in linear arrays or two- or three-dimensional arrays to increase the rate of delivery or the amount of substance delivered in a given period of time. Dermal-access members may be incorporated into a variety of devices such as holders and housings that may also serve to limit the depth of penetration. The dermal-access members of the invention may also incorporate or be in fluid communication with reservoirs to contain the substance prior to delivery or pumps or other means for delivering the substance into the patient under pressure. Alternatively, the dermal-access members may be linked externally to such additional components.
The device may include a luer type or other connection port for connection to a fluid delivery system such as a syringe, a pump, or a pen. In such an embodiment, the device may use a length of tubing for feeding a low dead volume body through an opening in the body.
Any suitable mechanism for delivering a fluid to the dermal-access members can be used. For example, a luer connection can be secured directly to the device for delivering a fluid from tubing or directly from a syringe secured to the luer connection. Furthermore, the device or portions of the device can be incorporated into an applicator that applies the device to a patient in a consistent manner, for example, at a consistent pressure, velocity and dose.
As an option, a removable shield can protect the device and particularly, the dermal-access members until use.
In addition to being a useful device for penetrating skin at an exact depth and for supplying an exact amount of fluid, the device is useful in enabling the placement of multiple dermal-access members simultaneously in a patient. This type of application is useful in both device and drug testing applications.
When the device is used to deliver substances to the intradermal space of a patient, the delivery of the substance typically results in one or more blebs left in the skin. As used herein, bleb refers to any site of deposition of a substance below the stratum corneum of the skin, generally in the intradermal space. Typically, the bleb extends laterally from the point of administration and distends upward. The bleb diameter and height are functions of instilled volume and rate of delivery and other factors. Secondary physiology effects, such as irritation or histamine release, can also alter bleb dimensions. Bleb duration can be a function of uptake distribution and clearance of the instilled components, both individually and in combination. Multiple blebs can be either overlapping or non-overlapping. Non-overlapping blebs allow for increased area of administration, but may contribute to imbalanced flow to individual points of administration within a system. Overlapping blebs may contribute to increase distension of tissue space, and result in better equilibrium of infusion pressure, but limits the benefits of increased fluid volume.
The device is constructed for penetrating selected layers of the dermis of a subject to a desired depth. The desired depth of penetration is usually determined by the substance being delivered or withdrawn and the target site. In this manner, a substance can be delivered, absorbed and utilized by the body substantially without pain or discomfort to the subject.
The advantages and other salient features of the invention will become apparent from the following detailed description which, taken in conjunction with the annexed drawings, discloses preferred embodiments of the invention.
The following is a brief description of the drawings.
A preferred embodiment of the invention is discussed in detail below. While specific exemplary embodiments are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations can be used without parting from the spirit and scope of the invention.
Referring to the drawings, particularly
A device 10 according to the present invention has a body 12 and dermal-access members 14. The device 10 optionally includes tubing 21 for delivering fluid to or removing fluid from the body 12 of the device.
The body 12 optionally has a low profile to lie flat against the skin of a subject. The low profile of the body 12 provides for ease of attachment to the skin and less obstruction to the subject. The low profile can be achieved by reducing the thickness of the body 12. In the embodiment shown, the body 12 has a substantially circular disk shape, although in alternative embodiments, the body 12 can have a non-circular or other more angular shape or be slightly arcuate. As an example, the diameter of the circular body 12 is preferably about 1-10 cm or less, although other sizes and shapes can be used. Embodiments can be manufactured with diameters of 5 mm or smaller.
The body 12, as shown in
One or more fluid channels 22 are provided in the body 12. The fluid channel 22 has an open inlet end 24. A coupling member 26 is optionally provided for coupling a fluid delivery mechanism to the body 12 at the open inlet end 24. Alternatively, no coupling member is provided and the fluid delivery mechanism is secured directly to the body 12. An axis of the fluid channel 22 optionally extends substantially parallel to the plane of the body 12. In this manner, the body 12 maintains a substantially flat, low profile configuration. Of course, other arrangements of the coupling member 26 and the fluid channel 22 are possible.
In the embodiment shown in
Raised protrusions 32 are provided in the recessed second surface area 30. As an exemplary embodiment, each protrusion 32 can be formed as a raised conical protrusion. As an alternative, other shapes such as cylindrical shapes may be used. Optionally, a raised conical protrusion 32 can have a flat upper surface to form a conical plateau or lower frustum of a cone. As an alternative, other upper surface shapes and contours may be used.
As shown in
As shown in
In the embodiment shown, one dermal-access member 14 is provided in each conical protrusion 32, although multiple dermal-access members 14 can be provided in each conical protrusion. Thus, in the embodiment shown in
The upper surface of the raised conical protrusion may be slightly elevated relative to the first surface area 28, flush with the first surface area 28, or slightly recessed relative to the first surface area 28. It is understood that the relative heights of the respective surfaces may vary depending on desired bleb formation, skin tensioning characteristics, and dermal-access member seating requirements. As an exemplary embodiment, the first surface area 28 will be slightly lower than the top of the protrusions 32, for example 0.25 mm shorter.
Outside of the first surface area 28, the device 10 chamfers to the outer edge 16 to prevent or reduce edge effect, defined as pressure applied to the outer edge of the device that may impede performance of the device 10 or cause the subject discomfort.
In the embodiment shown, each dermal-access member extends about 1 mm from the top of the protrusion 32 with about 0.5 mm to about 2 cm of the dermal-access member remaining within the protrusion 32. In an exemplary embodiment, the device uses hollow dermal-access members 14. The dermal-access member tips can be beveled, for example, at a single bevel angle of approximately 15-35�, preferably 28�.
As shown in
The device 10 can also include a cover portion (not shown in
In the embodiment shown, the tubing 21 delivers fluid to the channel 22. The tubing 21 is secured to the inlet end 24 of the body 12. The tubing 21 may be glued to the coupling member 26. Optionally, the tubing 21 includes 16 gauge catheter tubing with a luer fitting. (not shown) The other end of the tubing can be connected to a supply or receiving device. The supply device may be a syringe (not shown), a unit dose delivery device (not shown), or a suitable metering pump or infusion device (not shown) for delivering a substance to device 10 at a controlled rate. This method can also be used to withdraw a substance from a subject.
In an exemplary embodiment, the channel 22 is smaller than the tubing 21 feeding the channel 22, but significantly larger than the exit diameters of the dermal-access members 14 so as not to result in unnecessary high pressures. The tubing should not be the limiting factor in the flow of substance through the device. Optionally, the size and configuration of the dermal-access member and arrangement of recesses are the primary factors in controlling substance delivery. The body 12 of the delivery device is preferably designed to deliver fluids in the range of about 2-5 psi up to about 200 psi, for example, 50-75 psi. The body 12 can also be designed to deliver at higher and lower pressures. The body and all fitting and components of the device should be rigid enough to withstand pressures on the device without deflection or loss of liquid sealing.
The device 10 may be taped with tape 38, or otherwise secured, onto a subject during application. Alternatively, the device can be manually held in place without any other securing mechanism. The device 10 can also be designed and/or manufactured with tape or other suitable securing mechanism, such as an adhesive, as part of the device 10. Optionally, the device can be installed or incorporated into an applicator device for mechanically applying the device to a user.
In the example shown in
A chamfer 42 extends to the edge of the device. The chamfer 42 helps ensure that the proper pressure is applied to the dermal-access member 14 and prevents any adverse effect of the edge from the device during delivery.
In the embodiment shown, the flange 44 surrounds the edge of first area 28 for application of an adhesive ring 46. The flange 44 can, for example, extend about 1 cm beyond the edge of the device. The flange can be rigid or flexible and can be designed to extend as far as necessary beyond the edge of the body 12, depending on the necessary level of securement and its placement on the subject. The flange 44 should be slightly recessed relative to the first areas 28 to compensate for the thickness of the adhesive 46, and to minimize or eliminate interference with the delivery area. For example, the flange can be recessed 1 mm although the amount the flange 44 is recessed can vary. Generally, the adhesive 46 should be located at a distance from the delivery site, preferably, as far away as is practical, so as not to interfere with delivery characteristics.
The adhesive 46 is preferably a pressure sensitive adhesive capable of attaching the device 10 to the surface of the skin of a subject and is preferably applied directly to the flange 44. The adhesive 46 can be a double-faced adhesive foam tape having one face bonded to the flange 44. The device 10 is preferably packaged with a release sheet covering the adhesive 46 that can be removed immediately before use. As an alternative, any suitable means for maintaining biological interface of the device with a subject may be used.
The flange 44 and adhesion arrangement 46 can also be provided in the other embodiments.
The top face 20 of the body 12 defines a channel 22 for insertion of tubing 21 for delivery of the fluid. This feature may be present in the other embodiments, although not clearly shown in previous figures. The channel 22 may extend from the edge of the main body 12 to the center of the top face 20 of the body 12 and is in fluid communication with the dermal-access member 14. In the exemplary embodiment, the tubing extends into the body to a narrowing stop in the channel. However, the device can be designed with the tubing extending only to the edge of the device or all the way through the channel to the dermal-access members. The channel 22 can be, for example, about 1 mm in diameter, although the channel can be modified depending on the desired delivery characteristics, including delivery rate and volume. The channel 22 can narrow as necessary to reduce any dead space inside the device but outside the tubing. For example, the channel can be, for example, 0.5 mm in diameter or less. Dead space results in wasted substance remaining in the device and not delivered to the subject and/or requires more pressure than would otherwise be necessary to deliver the substance to the subject. The top face 20 of the body 12 also has a raised area 52 on the center of the top face 20. The raised area 52 has a wall or rib 50 surrounding the fluid channel 22 to enhance sealing of the channel 22 and to prevent any adhesive from wicking into the fluid channel during assembly. As an example, the rib 50 can be about 0.5 mm in height.
A cover portion 47 is provided to seal the fluid channel 22. The cover portion 47 has an inside face and an outside face (not shown). Preferably, the cover portion 47 is circular with a recess 49 on the inside face that accommodates the raised area (not shown in
Shield 48 can be provided for protecting the dermal-access member 14 before use. As shown in
As shown by the alternate protrusion shown in
The device 10 shown in
As an example, the device 10 shown in
The device 10 shown in
By way of example, the device 10 shown in
The device 10 shown in
By way of example, the elliptical embodiment of the device 10 shown in
Another embodiment of the dermal-access member array is shown in
The arrangement and relative heights of the dermal-access members, recesses, and protrusions can be modified to accomplish or emphasize any number of intended beneficial characteristics of the invention. Specifically, the length, width and spacing of the dermal-access members can vary depending on the pharmaceutical agent being administered or required to penetrate the skin to the optimum depth for the specific pharmaceutical or bioactive agent being administered. The device of the present invention maximizes the effective penetration of dermal-access members to a targeted depth. The device can control the size of the bleb. In a device with multiple dermal-access members, the device can be engineered to control the instillation patterning of individual blebs and their relationship to each other. Non-communication between individual dermal-access members can be meaningful for deposition of large volumes in a broad biological space or the deposition of multiple fluids, or in designing the pressure parameter of a dermal-access member. The device can be designed to provide sufficient fluid flow path to accommodate the desired velocity and rate of fluid to be instilled and to minimize the amount of void volume. The device can further be designed as a function of the desired bleb pattern and for application of a particular fluid at a particular site to minimize the area of application.
Generally, the patterning of the dermal-access members can be designed to achieve desired characteristics. Typically, a minimal number of dermal-access members can be used to reduce the pain or the perception of pain by a subject, manufacturing complexity or cost, the number of potential failure points, the complexity of the device fluid dynamics, and the dose lost to void volumes in the device or system. The number of dermal-access members can be increased to decrease the possibility of blocked fluid paths, to increase the distribution area of instilled fluid to accommodate a greater volume or delivery rate, and to potentially increase uptake.
Alternate arrangements for delivering fluid to the dermal-access members include but are not limited to multiple reservoirs; a manifold arrangement in which fluid is communicated from a reservoir, through individual channels to the dermal-access members; and independent channels. In addition, the channels can be provided with individual or combination valving or other means for fluid flow rate control.
As discussed above, the number and arrangement of dermal-access members and protrusions in each of the embodiments can depend on the desired range of fluid delivery volume. Furthermore, the recessed second surface area surrounding each protrusion can be arranged based on the desired range of fluid delivery volume. For example, a three member array that delivers 100 μl of fluid may have recesses surrounding each dermal-access member of approximately 5 mm in diameter. Conversely, a single member array that delivers 100 μl of fluid may have a recess surrounding the single dermal-access member with an approximately 10 mm diameter. As discussed above, the size and arrangement of the recesses depend on the desired flow characteristics, including the volume and rate of delivery of the substance.
A method for delivering or withdrawing a substance through the skin is also provided. The device is positioned in a target site on the surface of a subject's skin. The body is pressed downwardly against skin with a pressure sufficient to cause dermal-access members to penetrate the layers of skin. The depth of penetration is dependent upon the length of dermal-access members, the spacing of the dermal-access members, and the dimensions of the body, including the height of the protrusion, pressure exerted on the device, and the tensioning of the skin resulting from the body.
The skin of a subject has elastic properties that resist penetration by the dermal-access members. The skin can be stretched by the raised first surface area until the skin is taut before the dermal-access members penetrate the skin. A penetrating pressure can be applied to the device until the first surface area contacts the skin. This promotes uniform penetration of the skin by each of the dermal-access members. Consequently, when the device is secured to skin with either a manual application or adhesive, a pressure is constantly applied to dermal-access members 14.
A substance is supplied to the device and fed to dermal-access members for delivery to the subject. In alternative embodiments, a substance is withdrawn from the subject in a similar manner.
For a bolus type injection, the spacing of the delivery points is not as important because the pressure is higher and delivery occurs at each dermal-access member approximately simultaneously. Dermal-access member spacing in the bolus type injection may determine whether a single bleb or multiple blebs form.
For lower rate deliveries, it is beneficial to ensure that the delivery points are spaced close enough together to create a single bleb. As delivery at a particular dermal-access member in a multi-dermal-access member device begins, the pressure at that particular dermal-access member decreases. At relatively low delivery pressures, if the dermal-access members are spaced too far apart, the first dermal-access member to form a bleb will be the preferential path because the substance to be delivered will inherently follow the path of least resistance. Thus, by having all the points feed the same bleb, no preferential flow through a particular dermal-access member or delivery point should occur because pressure will be equalized across the dermal-access members.
The device of the invention can remain interfaced with the skin for sufficient time to withdraw from or deliver to the subject the desired substances. The length of time the device is required to be attached or in communication with the skin of the subject is usually dependent on the substance being delivered or withdrawn, the volume of the substance, the target area on the skin, the depth of penetration, and the number and spacing of dermal-access members. The amount of time the device is secured to the skin may reduce the amount of leakage from the skin after delivery of the fluid.
Many of the considerations in designing the device of the present invention involve proper placement of the dermal-access members, including placement of the dermal-access members at the proper depth. Specifically, pharmacokinetics (PK) for certain classes of medicaments can be improved by administering the medicament at a specified place below the stratum corneum.
Generally, deposition in intradermal tissue results in faster drug onset kinetics for system uptake and bioavailability, and increased bioavailability for some drugs. However, intradermal delivery is limited in that intradermal tissue space is highly compact and has limitations on the total amount of volume which can be administered, the rate at which such fluid can be administered, and the pressure required to administer such volume. Generally, the subcutaneous layer is not well perfused by capillaries. As such, absorption is both slower, and in some cases, decreased bioavailability.
Thus, the PK outcome of dermal-access delivery is specific to the deposition depth and patterning of the administered fluid and such deposition can be mechanically controlled via design of the device of the present invention. It has been shown that delivery of medicaments to two different depths increases the PK benefits, for example, delivery to both shallow subcutaneous areas and intradermal areas.
The present invention can include a device to deliver the medicament to two different depths, and specifically, to two different physiological tissue compartments, such as shallow subcutaneous and intradermal. This can be accomplished, for example, by dermal-access members of different lengths. Other geometric or mechanical mechanisms can also be designed to deliver fluids to different depths. The device can also be provided with flow restrictors to deliver differing amounts of fluid to different areas.
For each of the embodiments discussed herein, the device is optionally radiation stable to allow for sterilization, if radiation is to be used. Optionally, the body should be transparent or translucent to allow for light to penetrate and cure the UV adhesive holding the dermal-access member secure. As another option, the body can be opaque and epoxy can be used to secure the dermal-access member. It is noted that having a transparent body enables a user or other person administrating the device to properly prime the device by ensuring that no excess air is in the device. Furthermore, the body and cover portion material should be stiff enough so as not to deflect during normal use conditions and should be able to withstand internal fluid pressure in the range of about 2-5 psi to about 200 psi without failure or leaks. However, the flange and adhesive can be as flexible as necessary for comfortable and secure attachment to the subject. The body and cover portion material can selected to be non-affected by the drug and having no effect on the drug candidates to be used. The body and the cover portion material should also be hypoallergenic.
The device of the invention can optionally be used as a disposable, single-use device. The device can be sterilized and can be stored in a suitable sterile package.
Adequate dermal-access member seating is an important aspect of the present invention. Successful dermal-access member seating is defined as positioning the dermal-access members in the skin such that fluid delivered through the dermal-access member or dermal-access members does not leak out of the skin.
Generally, there are four factors which contribute to a desirable dermal-access member seating: dermal-access member length, dermal-access member protrusion geometry, dermal-access member overtravel, and the dermal-access member seating velocity. Overtravel is defined as the extent that the upper face of the protrusion extends beyond the adhesive or other securing mechanism of the device i.e., the bottommost face of the device. The embodiment shown in
Exemplary embodiments of the geometry of the device in general and of dermal-access member manifolds have been discussed above.
Experiments have shown that smaller protrusion diameters increase the effectiveness of dermal-access member seating. It was believed that the higher local pressure exerted by the smaller surface of the protrusion for a given force contributes to the beneficial dermal-access member seating. It is further believed that the smaller surface area of the face of the protrusion has a smaller local effect on the development of the bleb.
In one such experiment, a device was applied to a swine test subject to determine the effectiveness of smaller diameter protrusions as compared to larger diameter protrusions. The experiment was conducted at a constant delivery pressure of 15 psi, with a 50 μL air bolus, and with needles as the dermal-access members. The protrusions are conical protrusions with a flat top surface. The dermal-access members extend 1 mm above the top surface of the protrusion. Although the surface is flat in this experiment, as noted above, the top surface of the protrusion can be concave or convex. If the top surface is concave, the length of the dermal-access member is measured from the outer rim of the top surface to the top of the dermal-access member. If the top surface is convex, the length of the dermal-access member is measured from the uppermost tangent of the surface to the top of the dermal-access member.
In the aforementioned experiment, the smaller diameter protrusions are about 1 mm (0.0375″) in diameter and the larger diameter protrusions are about 2 mm (0.075″) in diameter. The experiment also accounted for varying amounts of overtravel. The results are shown in
As can be seen from
Interestingly, overtravel did not seem to negatively affect infusion rates. This was somewhat surprising, given the previous experience with overdriven or overtraveled needles. It has been the conventional experience when using 1 mm needles mounted in catheter tubing that pushing the catheter into the skin significantly affects the pressure required to infuse at a given rate in a constant pressure system. However, the amount of overtravel necessary to produce this effect is likely larger than the maximum overtravel of 0.040″ seen in this experiment. This suggests an optimal overtravel amount which can be discerned from further experiments.
It has further been shown that an increased velocity in the application of the dermal-access members can increase the effectiveness of the seating.
An applicator for mechanically applying the device to a patient can control the velocity of the dermal-access members. For example, an applicator such as a Minimed SOF-SERTER™ insertion device or a BD INJECT-EASE™ device can be modified to apply the device to a user at a desired velocity. The device is driven toward the skin by springs contained in the applicator and results in the dermal-access members seating into the skin of a subject. Among other factors, the strength of the springs determines the velocity of the dermal-access members.
Experiments have shown that there is a continuum of velocity ranges within which dermal-access member seating improves with velocity, for a given skin type, manifold mass, and needle sharpness.
Initial seating experiments in Yorkshire pigs utilized a single spring rate of about 5 lbf/in. This allowed a 1.7 gram manifold to be propelled at about 6.3 m/s. At this velocity, most 1 mm and 3 mm dermal-access members seated without leaking. However, a large number of manifolds did not have enough energy to seat the dermal-access members to the required depth. Heavier manifold tests, from a drop-center design, had velocities of about 3 m/s. At this velocity, most of the 1 mm dermal-access members leaked. Similarly, most of the 3 mm dermal-access members produced very shallow blebs. One manifold arrangement uses two springs with spring constants of 3.2 lb/in, and is less massive than other manifolds. This manifold arrangement enables a manifold velocity of about 12 m/s or greater. With this arrangement, nearly 100% of the dermal-access members seated properly. Accordingly, it has been shown that, for this arrangement, a velocity of about 6 m/s to 18 m/s is ideal, optionally about 6 m/s to about 25 m/s. It is noted, however, that these resultant, calculated velocities were calculated based on energy conservation equations based on known initial forces, and does not account for any friction within the applicator or friction of the dermal-access members passing through the skin. The actual velocities in this example could be much less, for example, 50% less.
One experiment determining dermal-access member velocity utilizes a mechanical applicator in which a device with a three dermal-access member manifold is loaded. In this experiment, 34 gauge dermal-access members are used. A coil spring is placed on a post of the manifold to tension the manifold in the applicator. A luer and line arrangement can supply fluid to the manifold at a constant pressure. The applicator is placed on a swine, the applicator is activated to release the spring to drive the manifold with the dermal-access members into the skin, and fluid is delivered to the subject. In this experiment, the manifold is driven about 5 mm. The following parameters were considered:
Springs Force: None;
Low: 1 lb. initial spring force, 0.5 lb. final force; or
High 2 lb. initial spring force, 1 lb. final force
Device: Center or Side
Adhesive: Full or Missing (safety)
Septum: With or Without
Member Length: 1 mm or 3 mm
The results are shown in
The following is a description of a further experiment demonstrating the importance of dermal-access member velocity. The tests were conducted to determine the more effective dermal-access member seating arrangement between a side push microinfuser and a drop-center infuser. The drop-center manifold ("heavy") weighs about 7.8 grams, and the side push manifold weights about 0.4-0.6 g. Therefore, for a given spring or spring set used to drive the manifold, the drop-center design will be at least 10 times slower in its initial velocity than the side push design. For this experiment, manifolds weighing about 1.7 grams were used as "light" manifolds. The results are shown in
The lack of obstructions on the face of the device has also been shown to increase effective dermal-access member seating. For example, the exemplary embodiment shown in
While various embodiments have been chosen to illustrate the invention, it will be appreciated by those skilled in the art that various additions and modifications can be made to the invention without departing from the scope of the invention as defined in the appended claims. For example, the body of the device may be made as an integral one-piece unit. In alternative embodiments, the body can be made from separately molded sections or pieces and assembled together. The molded sections can be assembled using an adhesive, by welding, or by the use of mechanical fasteners. Additionally, any number of dermal-access members may be provided on the device.
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I wonder about the virtually microscopic worm that lives in each of our tear ducts. I think they are symbiotic, keeping the tear duct clean. I think I can sense they are lonely for some reason. At least they aren't obtrusive. I wonder if mine has died. I don't know where to get another one. They will probably be resurrected with us.


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Figure 1.
Characterization of the isolated and purified pollen at respective stage. (A-H) DAPI staining of the purified pollen: (A, B) Uninucleate microspores (UNMs). (C, D) Bicellular pollen (BCP). (E, F) Tricellular pollen (TCP). (G, H) Mature pollen grains (MPGs). (I) Germinated pollen grains (GPGs). (J) The purity of the purified pollen was determined by DAPI staining and microscopy, and percentage of GPGs. Bars = 100 μm in A to I.
Wei et al. BMC Genomics 2010 11:338 doi:10.1186/1471-2164-11-338


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Arizona has the best solar resource in the country. Outside of California, no other state boasts as much installed solar capacity, and Arizona has added thousands of solar jobs in recent years, making solar energy a true homegrown success story.
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Colorado's Solar-Power Goal: Grow It Tenfold
Colorado's solar-power industry is readying a "Million Solar Roofs" campaign to raise the amount of solar power generated in the state to 3,000 megawatts — nearly one-fifth of the state's electricity use.
Federal Energy Regulatory Commission Proposes Key Interconnection Rule, SEIA Applauds
WASHINGTON, D.C. – The Solar Energy Industries Association® (SEIA®) today praised a proposed rule issued by the Federal Energy Regulatory Commission (FERC) that will, if finalized, expedite and reduce the cost of solar project interconnection while maintaining electric system reliability and safety.
Falling Costs Make Sunny Skies for U.S. Solar Industry
As the United States continues a slow climb out of economic difficulty, one industry continues its steady ascent — the solar energy industry. And with more than 224 sunny days last year in San Antonio alone, Texas could play a big role in this ascent now and in the years to come.
Study: Solar 'Net Metering' To Provide Over $92 Million in Benefits to California Ratepayers
A study released today by the Vote Solar Initiative finds that net-metered rooftop solar will provide more than $92 million in annual benefits to ratepayers of California's three investor-owned utilities.
School District Investigating Solar Energy
In an effort to be green and get green, the Jefferson Township school district is investigating the possibility of bringing privately funded solar energy to the district that would also provide revenue for projects on the district's wish list.
Clean Energy Standard Could Have Big Impact
On March 1, I shared a great post on the newly proposed Clean Energy Standard Act of 2012. Two months and one day later, the Energy Information Administration (EIA) released a report on an analysis of the Clean Energy Standard Act. The general conclusions are presented in the following EIA post.
Walmart to Install Solar Panels on 27 Stores in Mass.
Retail giant Walmart said it plans to install solar panels on top of about half of its roughly 50 Massachusetts stores as early as August as part of an expansion of solar power in the state.
State Officials Look for Path to Rescue Market for Solar Incentives
The market that New Jersey officials set up to subsidize solar energy needs a rescue or there will be disastrous layoffs in the industry, business leaders, politicians and regulators say.
Branchburg Hopes Solar Panels Will Save Community Some Cash
The township is putting the finishing touches on a solar panel array designed to power almost all of the Branchburg municipal building on Route 202 — a project officials say could drop energy costs by at least $5,000 a month.


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