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4 bedroom character property for sale Pentre, Minera, WrexhamA Grade II listed 4 Bedroom property of architectural merit surrounded by mature gardens with an adjoining paddock, extending in all to approximately 1.5 acres. The property has elegance typical of its era and has been updated to the highest of standards to include all modern fixtures and fittings. More details ›
£429,000 Guide Price
Guide Price £429,000
4 bedroom detached house for sale New Brighton, Minera, Wrexham, LL11Occupying a rural position on the upper fringe of New Brighton and enjoying spectacular views over five counties, Bwth Farm comprises a four bedroom stone built detached family house with newly replaced conservatory extension. There are outbuildings including stables together with a derelict cot... More details ›
4 bedroom detached house for sale MineraA mdoern 4 Bedroom DETACHED FARMHOUSE with good quality adjoining pasture land extending to about 8 acres. The property enjoys a peaceful rural location and southerly aspect enjoying fine views over the surrounding countryside towards Coedpoeth a distance of about 2 miles. The house offers spaci... More details ›
4 bedroom detached house for sale Pentre, Minera, WrexhamA SUPERB FOUR BEDROOM DETACHED PROPERTY LOCATED IN A PRIVATE AND ELEVATED POSITION SURROUNDED BY WOODLAND, EXTENSIVE GARDENS AND STABLES WITH A RIVER RUNNING ADJACENT. THIS PROPERTY WOULD MAKE AN IDEAL FAMILY HOME WITHIN AN IDYLLIC LOCATION. VIEWING HIGHLY RECOMMENDED... More details ›
Added on 16/05/2015 by Town & Country Estate Agents, Wrexham - Sales. Call: 01978 511012 Local call rate
£295,000 Offers in Region of
Offers in Region of £295,000
3 bedroom detached house for sale Old Road, Minera, Wrexham, LL11Viewing is recommended of this extended three bedroom detached family residence situated in a rural location with exceptional views beyond. The accommodation briefly comprises entrance porch, hallway, lounge, sitting room, dining room, kitchen, utility, downstairs cloakroom and a pleasant sunroo... More details ›
4 bedroom detached house for sale Church Road, Minera, WrexhamOccupying a central location within this popular village is this attractive, detached stone cottage which has to be viewed to be fully appreciated, offering spacious internal family accomodation with some character features as well as a high standard of fixtures and fittings. The original structu... More details ›
3 bedroom detached house for sale Willow Bank Road, Minera, WrexhamSET IN AN ENVIABLE POSITION THIS THREE BEDROOM DETACHED CHARACTER COTTAGE OFFERS SPACIOUS ACCOMMODATION INCLUDING SIDE AND FRONT PORCH, LOUNGE, KITCHEN/DINER, UTILITY ROOM, SNUG, CLOAKROOM. ON THE FIRST FLOOR THERE ARE THREE BEDROOMS AND A BATHROOM. TO THE OUTSIDE A GOOD SIZED DRIVEWAY OFFERS A... More details ›
Added on 31/03/2015 by Town & Country Estate Agents, Wrexham - Sales. Call: 01978 511012 Local call rate
4 bedroom detached house for sale Eversley Court, Minera, WrexhamTown and Country are delighted to introduce this well maintained and presented four bedroom detached family home to the market benefitting from oil central heating and double glazed windows throughout. The ground floor internal accommodation briefly comprises a porch/hall, cloakroom, a lounge, d... More details ›
Reduced on 06/03/2014 by Town & Country Estate Agents, Wrexham - Sales. Call: 01978 511012 Local call rate
4 bedroom detached house for sale New Brighton, Minera, Wrexham, LL11 3DTThis well presented four bedroom detached property was designed and built by the current owners. Situated on the outskirts of Minera, in the hamlet of New Brighton. To take advantage of the views this is an upside down house with the possibility of using the downstairs as self contained living ac... More details ›
£220,000 Offers Over
Offers Over £220,000
4 bedroom detached house for sale Eversley Court, WrexhamWingetts are pleased to offer to the market this Four Bedroom Detached Family Home which benefits from oil central heating and double glazed windows. The ground floor accommodation briefly comprises: an Entrance Hall, cloakroom, a lounge, dining room and a fitted kitchen with a utility room off... More details ›
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Search Results For "Robert Ellis"
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In 2012, Aetna and Inova, a not-for-profit health system in Virginia, formed a joint venture health plan: Innovation Health. The health plan is an entirely new entity owned jointly by both organizations. Its network emphasizes Inova's providers.
By integrating payer and provider, Innovation Health has the potential to more effectively manage population health, a central capacity in a value-based system. In addition to aligning incentives through shared risks and rewards, the partnership facilitates greater care coordination. Aetna, for example, is able to support Inova in its abilities to track patient health and exchange information between physicians and across settings of care.
Innovation Health's version of integration—a growing trend—is only one approach among many. Aetna has several private-label health plan ventures in which it still performs the traditional functions of the insurer and the health system is simply the preferred provider. There are also an increasing number of payer-provider mergers and acquisitions, and instances of health systems launching their own health plans. Each model presents distinct opportunities and challenges associated with features such as market reception, regulatory approval, compliance with applicable laws and regulation, resource intensity, and competition.
Concerns about competition between products of the individual partners and those of the new health plan are a potential barrier to partnership with the joint venture model. In this example, Innovation Health only is available in Northern Virginia. On and off the Exchange, Aetna plans are not offered in the same locality, but remain available in other parts of the state. What lies ahead if Inova chooses to expand geographically? Furthermore, Innovation Health only sells commercial and Medicare Advantage plans. As to other lines of business, Inova owns INTotal Health (formerly known as Amerigroup Virginia), a Medicaid managed care plan it purchased the same year it partnered with Aetna. Are economies of scale best optimized with Inova operating two plans with separate lines of business?
This interesting joint venture approach to payer-provider integration may be suited to markets in which the insurance company partner is seeking new pathways. At the time the venture was announced, Aetna had approximately 600,000 members across Virginia while Inova was providing care to more than 1.1 million residents of Northern Virginia, annually.
DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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Just saw the 1st episode. As Jeff described it in one of his recent DisneyGeek weekly updates, it's like a real live Incredibles family.
Although there were a couple of slow scenes, overall, I really like this new TV Series, and I'm looking forward to seeing more.
Who else has seen it, and what do you think?


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Welcome To Spirit HalloweenX
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Renaissance Wench Adult Womens Costume
No one will be rolling their eyes at you in this Renaissance Wench adult womens costume! They'll be fixated on your sexy white peasant blouse with attached lace up bustier and adjustable skirt revealing just the right amount of skin. So this Halloween, they'll be at the beck and call of a wench of…
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Every proper lady needs some jewels to match any outfit. The Medieval Chain Necklace features a gold chain with little amethyst style gemstones.
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Clean Design Flash Template 6388
Dynamic Flash Site Template that was composed by our webmaster artist Di.
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Clean Design Flash Template 6388 is available in the following sources: .SWF, .HTML, .PSD, and .FLA. Software required includes Winzip 9+ (Windows) or Stuffit Expander 10+ (Mac) for uncompressing .zip files, Adobe Flash MX+, Adobe Dreamweaver 8+ (or Microsoft Expression Web), and Adobe Photoshop CS+. It has had a total of total of 10 downloads since it first appeared.


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what is this? the E looks kind of funny, maybe a company symbol?
Answers (1)
14 May 2007
E613 is 25mg Hydroxyzine Pamoate (Vistaril) is an antihistamine. This drug relieves itching and allergic skin reactions; may relieve emotional conditions that result in anxiety and tension; reduces nausea and vomiting; helps make you sleep before surgery or at bedtime, and may help with pain relief after surgery.
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dark and light green capsule
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3 part green capsule (unusually long), light green on ends, dark green in middle, J on middle
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You can now invite anyone to meet at your favorite Starbucks.
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42 year old woman | Roswell, GA, USA | Seeking men 34-50 in Georgia, United States
Active within 3 days
Life's Butterfly. Exquisite Beauty, Sultry eyes and Command Presence. Check out this profile, it is real.
Daily routines sometimes takes us away from life's simple pleasures. In designing my day off from work, I enjoy waking up to a cup of tea and a light breakfast. By mid-morning and schedule permitting, if my 4 mile run is completed, I'm off to an excellent start. By lunch time, I''m usually pretty hungry. Enjoying lunch while out on the town or grabbing something as I review emails or adjust my schedule, is more or the norm. I'm a big sports fan, so getting sideline tickets or watching it in my living room puts me right in the action. I truly enjoy cooking and baking, so I'll usually try a new recipe about once a week. I'm very good at my chef skills too and I take pride in that. On the professional side, I really enjoy what I do. I enjoy the ambience of sitting in the cockpit, all the way from takeoff to planning the final approach, especially when I'm faced with the challenge of an instrument approach. In describing myself physically, I am 5ft, 7 inches, usually weighing in at 126 lbs. During the winter months I can easily catch myself approaching 133 lbs. I'm sure we all face the challenge of how much turkey and stuffing we should have and whether or not we will actually face the cold the next morning for a 4 mile run. My solution though was to invest in a treadmill and commit myself to physical fitness. I am very please with where I am in life and giving my willing heart, I'm sure I'll enjoy sharing time with someone who also compliments me. In dating, I'm looking for someonee who cares about their physical well being, someone who values education and is not easily intimidated by a woman's success. Together we can accomplish more and enjoy each other.
Alumni connections , Business networking , Cooking , Exploring new areas , Playing sports , Political interests , Travel/Sightseeing , Watching sports , Wine tasting
Basketball, Football, Other types of exercise, Running, Swimming
I exercise 3-4 times per week.
I have Reptiles
I like Dogs, Exotic Pets, Fish, Gerbils / Guinea Pigs / Etc., Horses
I had a ball python for a couple of years. Not sure how I survived then as she got out a couple of times and frankly I'm afraid of snakes. I guess that must have helped me get over this fear, well just a little.
Middle of the Road
Enjoying the freshly squeezed orange juice on the streets of Bangkok.
Massachusetts Institute of Technology, Cambridge, MA
My favorite TV show is any sporting event that makes it to overtime. Fried plantain sprinkled with fresh ginger or ground cinnamon tops the list on my menu. Can't beat ice cream, any day, regardless of the temperature outside.
I have to get at least a weekly dose of airbore activities. I am hooked to the sky and need to soar frequently to keep my balance. A Bell Jet Ranger or a Cessna can do the trick. Doing chandelles on a date would truly rock.
I've had a lot of reading assignments lately, and I enjoy books on strategies and planning. On the lighter side, I like to browse through fashion trend magazines and aviation happenings.
Z{{Cta}} {{#if HasMoreInfo}} ?{{CtaSecondary}} {{/if}}
|What she is looking for
|5'7" (170cms)
|5'11" (180cms) to 8'0" (243cms)
|Body type:
|No preference
|No preference
|Dark brown
|No preference
|No Way
|No Way
|Social Drinker
|No preference
|Executive / Management
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|I'll tell you later
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|No preference
|Have kids:
|Yes, and they sometimes live at home (2)
|No preference
|Wants kids:
|No, but it's OK if my partner has kids
|No preference
|I'll tell you later
|No preference
|I'll tell you later
|No preference
|No preference
|Graduate degree
|No preference


text:
Disclosed is a delivery device for controllably delivering a prosthetic bulking device below a tissue surface such as below the mucosa to treat gastroesophageal reflux disease. The delivery device may be embodied in a deployment catheter, an endoscope, or an endoscope attachment. The bulking device may additionally be explanted from beneath the mucosa. In one embodiment, the bulking device comprises a hydrogel.
1. A method of implanting a bulking device beneath the mucosa in the lower esophagus, comprising the steps of:
puncturing the mucosa with a device having a first cross sectional area;
creating a pocket beneath the mucosa and in communication with the puncture;
enlarging the puncture by introducing a dilator through the puncture; and
introducing a bulking device through the enlarged puncture and into the pocket.
2. A method of implanting a bulking device as in
3. A method of implanting a bulking device as in
4. A method of implanting a bulking device as in
5. A method of implanting a bulking device as in
6. A method of implanting a bulking device as in
7. A method of implanting a bulking device as in
8. A method of implanting a bulking device as in
9. A method of implanting a bulking device as in
10. A method of implanting a bulking device as in
11. A method of implanting a bulking device as in
12. A method of implanting a bulking device as in
13. A method of treating a condition in the lower esophagus, comprising the steps of:
creating a pocket beneath the mucosa in the lower esophagus; and
positioning an expandable hydrogel bulking device within the pocket, wherein the bulking device has a diameter prior to implantation within the range of from about 0.2 mm to about 5 mm.
14. A method as in
15. A method as in
16. A method as in
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19. A method as in
20. A method as in
21. A method as in
22. A method as in
23. A method as in
24. A method of explanting a bulking device positioned beneath the mucosa in the vicinity of the lower esophageal sphincter, comprising the steps of:
locating a solid bulking device positioned beneath the esophageal mucosa;
using a cutting tool to create a tunnel through the mucosa; and
applying suction to explant the solid bulking device through the tunnel.
25. A method of explanting a bulking device as in
26. A method of treating a condition in the lower esophagus, comprising the steps of:
creating a pocket beneath the mucosa in the lower esophagus;
positioning an expandable hydrogel bulking device within the pocket; and
removing the bulking device from the pocket by creating a passageway through tissue to the bulking device and using suction.
27. A method of treating a condition in the lower esophagus, comprising the steps of:
creating a pocket beneath the mucosa in the lower esophagus;
positioning an expandable hydrogel bulking device within the pocket; and
removing the bulking device from the pocket utilizing a laser.
28. A method of treating a condition in the lower esophagus, comprising the steps of:
creating a pocket beneath the mucosa in the lower esophagus;
positioning an expandable hydrogel bulking device within the pocket; and
removing the bulking device from the pocket using an energy source.
29. A method of treating a condition in the lower esophagus, comprising the steps of:
creating a pocket beneath the mucosa in the lower esophagus;
positioning an expandable hydrogel bulking device within the pocket; and
removing the bulking device from the pocket by cutting the bulking device into pieces.
The present application is a continuation-in-part of application Ser. No. 09/524,478 filed on Mar. 13, 2000 now U.S. Pat. No. 6,338,345 which is a continuation-in-part of application Ser. No. 09/287,607 filed on Apr. 7, 1999, entitled Submucosal Esophageal Bulking Device, now U.S. Pat. No. 6,098,629.
The present invention relates generally to the field of esophageal prosthetics. More specifically, a prosthesis delivery device is disclosed for submucosal insertion of a prosthetic bulking device.
Gastroesophageal reflux is a physical condition in which stomach acids reflux, or flow back from the stomach into the esophagus. Frequent reflux episodes (two or more times per week), may result in a more severe problem known as gastroesophageal reflux disease (GERD). Gastroesophageal reflux disease is the most common form of dyspepsia, being present in approximately 40% of adults in the United States on an intermittent basis and some 10% on a daily basis.
Dyspepsia, or heartburn, is defined as a burning sensation or discomfort behind the breastbone or sternum and is the most common symptom of GERD. Other symptoms of GERD include dysphasia, odynophagia, hemorrhage, water brash, and pulmonary manifestations such as asthma, coughing or intermittent wheezing due to acid aspiration. Dyspepsia may also mimic the symptoms of a myocardial infarction or severe angina pectoris. Many factors are believed to contribute to the onset of GERD including transient lower esophageal sphincter relaxations, decreased LES resting tone, delayed stomach emptying, and an ineffective esophageal clearance. Many in the field agree, however, that the primary cause of GERD is the lack of competency of the lower esophageal sphincter.
The lower esophageal sphincter, or valve, is comprised of smooth muscle located at the gastroesophageal (GE) junction and functions to allow food and liquid to pass into the stomach but prevent regurgitation of stomach contents. At rest, the LES maintains a high-pressure zone between 10 and 30 mm Hg above intragastric pressure. Upon deglutition, the LES relaxes before the esophagus contracts, allowing food to pass through into the stomach. After food passes into the stomach, the LES contracts to prevent the stomach contents and acids from regurgitating into the esophagus. The mechanism of LES opening and closing is influenced by innervation via the vagus nerve and hormonal control of gastrin and possibly other gastrointestinal hormones.
The severity of GERD varies from patient to patient and in extreme cases complications including esophageal erosion, esophageal ulcers, and esophageal stricture are observed. Esophageal stricture is a serious condition which results from prolonged exposure of the esophageal mucosa to acid reflux. The most common clinical manifestation of stricture is dysphasia. Unlike dysphasia from non-strictured esophageal reflux, dysphasia caused by stricture is progressive in that the size of a bolus which can pass into the stomach progressively becomes smaller. In addition to esophageal erosion and ulceration, prolonged exposure of the esophageal mucosa to stomach acid can lead to a condition known as Barrett's Esophagus. Barrett's Esophagus is an esophageal disorder that is characterized by the replacement of normal squamous epithelium with abnormal columner epithelium. This change in tissue structure is clinically important not only as an indication of severe reflux, but the appearance of columner epithelium in the esophagus is indicative of cancer.
Current methods to treat gastroesophageal reflux disease consist of lifestyle changes such as weight loss, avoidance of certain foods that exacerbate the symptoms of GERD and avoidance of excessive bending. Elevation of the head of the bed helps prevent nocturnal reflux. While these avoidance strategies may be helpful, there is relatively little data supporting the efficacy of lifestyle modification alone for the treatment of GERD.
Medications for the treatment of GERD have been administered for years with little or no success. Conventional antacids, such as TUMS� and ROLAIDS�, produce short-term relief, but often have side effects including diarrhea and constipation. H2 receptor antagonists, such as Cimetidine and Ranitidine, are relatively more effective in controlling GERD symptoms but these symptomatic therapies fail to treat the underlying cause of the disease. More powerful secretory inhibitors, such as the proton pump inhibitors Omeprazole and Lansoprazole are more effective than the H2 antagonists but these drugs are expensive and, in the long term, produce negative side effects.
Surgery has become an attractive alternative for the treatment of GERD when lifestyle modification and medications fail to treat this debilitating condition. There are numerous reflux operations available which perhaps reflect the inadequacy of any one procedure to totally control the problem. The most commonly performed operation, Nissen Fundoplication, has been effective, but is often complicated by stricture formation or gas bloat syndrome. A laparoscopic Nissen procedure has also been developed, adding another dimension of difficulty, and long-term results remain questionable. In addition, a percutaneous laparoscopic technique has been developed. (See, for example, U.S. Pat. No. 5,006,106 to Angelchik). Minimally invasive techniques, such as transesophageal implantation of a prosthetic valve have also been attempted. (See, for example, U.S. Pat. No. 4,846,836 to Reich). Despite extensive attempts in the field to treat and prevent GERD, existing forms of treatment all have shortcomings.
In view of the foregoing, and notwithstanding the various efforts exemplified in the prior art, there remains a need for a minimally invasive bulking prosthesis and deployment methodology for transesophageal delivery into the vicinity of the lower esophageal sphincter.
There is provided in accordance with one aspect of the present invention, a method of implanting a bulking device beneath the mucosa in the lower esophagus. The method comprises the steps of puncturing the mucosa with a device having a first cross-sectional area, and creating a pocket beneath the mucosa in communication with the puncture. The puncture is enlarged, and a bulking device is introduced through the puncture and into the pocket.
Preferably, the introducing step comprises introducing an expandable bulking device. The bulking device is expandable from an introduction cross-sectional area to an enlarged cross-sectional area, and the introduction cross-sectional area is greater than the first cross-sectional area. Preferably, the introducing step comprises introducing a hydrogel bulking device.
In one embodiment, the creating a pocket step comprises introducing a volume of fluid beneath the mucosa. The volume of fluid is generally within the range of from about 0.5 cc to about 5 cc.
The enlarging step comprises introducing a dilator through the puncture. In one embodiment the dilator removably carries an introducer sheath. The dilator is removed from the introducer sheath, and the bulking device is thereafter introduced through the introducer sheath and into the pocket.
In accordance with another aspect of the present invention, there is provided a method of treating a condition in the lower esophagus. The method comprises the steps of creating a pocket beneath the mucosa in the lower esophagus, and positioning an expandable bulking device within the pocket. Preferably, the expandable bulking device comprises a hydrogel. The bulking device has a cross-section prior to implantation within the range of from about 0.2 mm to about 5 mm. In certain embodiments, the bulking device has a cross-section prior to implantation of no more than about 3 mm, or no more than about 2 mm.
The method may further comprise the step of explanting the bulking device from the pocket. The explanting step may be accomplished using suction.
In accordance with a further aspect of the present invention, there is provided a method of explanting a bulking device positioned beneath the mucosa in the vicinity of the lower esophageal sphincter. The method comprises the steps of locating a bulking device positioned beneath the esophageal mucosa, and establishing a passage through the mucosa. The bulking device is explanted through the passage. The passage may be formed by suction, or by the use of a cutting tool such as a sharpened instrument, RF electrode or laser.
In accordance with a further aspect of the present invention, there is provided a method of implanting a bulking device beneath the mucosa in the lower esophagus. The method comprises the steps of puncturing the mucosa with a device having a first cross-sectional area, and enlarging the puncture. The expandable bulking device is thereafter introduced through the puncture to a position beneath the mucosa. The enlarging step preferably comprises advancing a dilator through the puncture.
Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.
Referring to
In the illustrated embodiment, the bulking device 16 is delivered in the submucosa 17. The submucosa 17 is a fibrous layer of tissue positioned between the mucosa 15 and a layer of circular muscle 19. The circular muscle 19 is surrounded by a layer of longitudinal muscle 21, as is well understood in the art. The bulking device 16 may be delivered in the mucosa or beneath the mucosa 15 as is discussed elsewhere herein. In particular, the bulking device 16 may be delivered within the submucosa 17 as illustrated, or at the interface of adjacent tissue planes, such as between the mucosa 15 and submucosa 17, beneath the muscularis mucosa or between the submucosa 17 and circular muscle 19. Preferably, the bulking device 16 is positioned radially inwardly from the circular muscle layer 19.
Although the anatomy illustrated in
As illustrated in
Ideally, the esophageal bulking device 16 is delivered in a position that extends across or is closely adjacent to the sphincter so that residual sphincter activity is optimized and the mucosal regions of the esophagus are protected from acid reflux. The precise positioning of the prosthesis 16 depends largely on the patient's anatomy and the severity of GERD, and will be a matter of clinical choice at the time of delivery. In patients with a hiatal hernia, for example, the esophageal bulking device 16 is delivered as close as possible to the sphincter but care must be taken to insure that the hernia will not perturb the operation of the bulking device 16.
Advantageously, the esophageal bulking device 16 of the present invention enhances any residual closing pressure function and length of the sphincter so as to effectively reduce or prevent the reflux of stomach contents into the esophagus. In an open or relaxed state, as shown in
Depending on the degree of LES dysfunction, more than one esophageal bulking device 16 can be delivered into the lining of the esophagus. With the 4 mm to 6 mm expanded diameter hydrogel bulking device discussed below, for example, anywhere from one to about six or more bulking devices may be implanted based upon a particular patient's condition. Where two or three or more esophageal bulking devices 16 are utilized to improve LES function, the bulking devices 16 may be spaced around the circumference of the LES. Generally, multiple bulking devices 16 will be located substantially in the same transverse plane perpendicular to the longitudinal axis of the esophagus. Use of multiple bulking devices 16 without rigid interconnection permits the LES to radially expand to a greater degree so as to permit bolus passage and better accommodate the natural function of the esophagus.
Depending on the patient's anatomy and the extent of GERD, esophageal bulking devices 16 having various lengths and cross sectional profiles are delivered so as to maximize operation with the residual LES function. Using common esophageal manometry and endoscopic techniques, for example, medical personnel can measure the degree of closure (e.g., closing pressure) achieved by the sphincter as well as any unique anatomical features of the lower esophagus for a particular patient when selecting specific shapes and designs of esophageal bulking devices 16 to be delivered.
Due to the irregular cross-sectional configuration of the closed sphincter, the cross-sectional configuration of the bulking device 16 can take on any of a wide variety of shapes including, but not limited to, those specific embodiments disclosed herein. In general, the desired expanded transverse plane thickness of the esophageal bulking device 16 will depend on the lumen diameter and the extent of LES dysfunction. Devices 16 produced in accordance with the present invention can be rated according to their bulking area, which represents the total cross-sectional area the device will occupy within the region at or about to the sphincter, referred to as the "bulking zone". In general, a larger transverse cross-sectional area will produce a higher closing pressure for a given state of the disease.
Suitable esophageal bulking devices 16 comprise a soft, flexible body that may have an expanded axial length from 0.5 cm to 5.0 cm, a width (circumferential direction) of 0.2 cm to 2.0 cm, and a thickness (radial direction) of 0.2 cm to 2.0 cm. Many esophageal bulking devices 16 of the present invention have a length within the range of 1.0 cm to 4.0 cm, a width within the range of 0.2 cm to 1.5 cm, and a thickness within the range of 0.2 cm to 1.5 cm. In one embodiment, the esophageal bulking device 16 has a length of 2.0 cm to 3.0 cm, a width of 0.8 cm to 1.0 cm, and a thickness of 0.4 cm to 0.6 cm. The cross-sectional configuration may be circular, oval or other configuration, as desired.
Length to cross section or thickness ratios are generally no more than about 15:1 and are often no more than about 6:1 or 4:1. Length to thickness ratios on the order of less than 3:1 may also be desirable depending upon the severity of the condition. The cross-sectional area of the bulking device 16 may also vary at different points along the length of the same device 16. As mentioned above, optimal dimensions may be patient specific and can be determined through routine experimentation of one of skill in the art in view of the disclosure herein.
An LES having a relaxed open diameter of 2.0 cm, for example, has a cross-sectional lumen area of 3.14 cm2. A 25% bulking function could be accomplished by providing a bulking device 16 having a total cross-sectional area in the bulking zone of about 0.785 cm2. The bulking area may represent the area of an esophageal bulking device 16 having a generally oval or rectangular cross-section (e.g., 0.443 cm�1.772 cm) which is adapted to extend axially for a length of 1 to 3 cm beneath the mucosa.
In general, the objective of the present invention is to increase the closing pressure and length of the lower esophageal sphincter. The present inventors believe that a closing pressure of at least a certain minimum closing threshold value, maintained along a minimum axial effective LES length will satisfactorily reduce esophageal reflux. In the intra-abdominal (i.e., inferior to the diaphragm 14) esophagus, about 2 cm of effective LES length appears desirable. An average pressure along that length is preferably in excess of about 10 mm Hg, preferably at least about 15 mm Hg, and optimally in the range of from about 15 mm to about 30 mm Hg.
Within certain outer limits, any increase in the closing pressure in the LES may improve symptoms. For example, some patients have an LES closing pressure on the order of about 5 mm Hg, which is accompanied by severe GERD symptoms. At the high end, a closing pressure in excess of about the minimum diastolic pressure inhibits blood flow, thereby increasing the risk of localized pressure necrosis. Pressure slightly below the minimal diastolic pressure may still interfere with swallowing function. The present invention therefore preferably enables increasing the closure pressure from a pretreatment value below about 10 to 15 mm Hg to a post treatment value of preferably on the order of from about 18 or 20 to about 25 or 30, along a length of at least about 1.0 cm and preferably at least about 2 cm or 2.5 cm or more.
Once the total desired cross-sectional area and length of the bulking device is determined for a particular patient or class of patients, the allocation of that cross-sectional area to a single bulking device or a series of bulking devices which together produce the desired cross-sectional area must be determined. This clinical decision will take into account any unique aspects to the patient's lower esophageal anatomy, together with the extent of the disease and consequent total area of bulking required. In general, a larger single bulking device will require a larger submucosal pocket for delivery and the consequent greater disruption of tissue in the immediate area of the prosthesis, which may be undesirable in some patients. In addition, a larger single device may have a greater likelihood of migration which would be reduced if the same total prosthesis volume was delivered in two bulking devices each having half the cross-sectional area of the single larger device.
The bulking device 16 is preferably flexible and has a high degree of softness which approaches that of the native mucosal tissue, to minimize trauma to the adjacent tissue. The material of the bulking device 16 is thus preferably soft enough so that is incapable of exerting sufficient localized pressure to cause pressure necrosis. A localized pressure in excess of about 70 mm Hg gives rise to a risk of localized tissue necrosis. As will be understood by those of skill in the art, the configuration of the bulking device 16 (e.g. sharp edges, etc.) operates in cooperation with the softness of the construction materials to optimize the compatibility of the bulking device. A smooth, blunt atraumatic outer surface is preferred.
One suitable bulking device construction comprises the use of an inflatable pillow or balloon, partially or completely filled with a liquid or semi-liquid, which allows one end to be compressed by peristaltic compression and the other end to expand bulbously. The ability of the volume of the bulking device to flow from one end of the bulking device to the other and back permits the passage of a peristaltic wave, as will be appreciated by those of skill in the art in view of the disclosure herein. Suitable elastomeric balloons comprise material such as silicone, latex, urethane, and others as will be understood by those of skill in the art.
In addition to being soft, the bulking device in some embodiments may also be compressible. This enables the filler 24 and body of bulking device 16 to expand when nothing is passing through the LES, but compress, for example, to no more than about 4 mm and preferably no more than about 2 mm in radial thickness during swallowing. After swallowing, the filling material 24 and body will desirably rebound back to facilitate the LES closure function. In this manner, the bulking device 16 can cooperate with any residual function of the LES to minimize the occurrence of reflux.
Referring to
The esophageal bulking device 16 can be manufactured as a unitary or multi-component structure in a variety of ways as will be appreciated by those of skill in the art in view of the disclosure herein. The bulking device 16, for example, may be a unitary structure molded or formed as a single piece of biocompatible foam material such as silicone foam or polyurethane foam, or may be cut from a block of such foam. Such foam parts can be made with an outer skin 26 of porous foam that facilitates tissue ingrowth. Hydrogel bulking devices are disclosed in detail below.
Alternatively, the esophageal bulking device 16 can comprise a body having at least two components connected together and can be made, for example, by positioning an outer sleeve or layer 27 of porous material such as expanded polytetrafluoroethylene (PTFE) or other tissue ingrowth material around the filler 24 by either a simple filling operation or by bonding the two materials together. If expanded PTFE is used, a PTFE surface etching step prior to bonding with a silicone based glue may be performed. Alternatively, a process of gluing by simultaneously compressing and heating a stack-up of foam, glue and PTFE can be employed. The outer layer 27 may be secured to the bulking device 16 in any of a variety of manners, such as by solvent bonding, thermal bonding, adhesives, and others as will be apparent to those of skill in the art in view of the disclosure herein.
The present inventors further contemplate embodiments of the esophageal bulking device 16 which have surface textures, coatings or structures to resist migration. In general, the entire outer surface 26 of the outer layer 27 or filler 24 can be coated or textured to facilitate tissue attachment such as by cellular ingrowth. The resulting attachment surface 26 can be integral with the bulking device 16 or can be directly or indirectly connected to the bulking device 16 so that the device 16 can be positioned and retained in the desired position within the esophageal wall. The outer surface 26 may additionally, or alternatively, be provided with any of a variety of tissue retention structures such as hooks, barbs, tacks, clips, sutures, staples, tissue adhesives, attachment strips, attachment spots, attachment connectors, or other attachment means which will be understood by those of skill in the art in view of the disclosure herein.
As illustrated in
For example, in an embodiment in which removal is not anticipated, the tissue ingrowth surface area can be as high as 75% to 100% of the surface 26 of the bulking device 16. Alternatively, in an application where the bulking device 16 is preferably removable after a period of time, the percentage of cellular ingrowth surface is preferably kept to the minimum required to reasonably resist migration within the esophageal wall. Thus, in some embodiments, the tissue ingrowth surface 28 covers no more than about 20% and possibly no more than about 5% of the total surface area of the bulking device 16. In this manner, trauma to the tissue upon removal of the bulking device 16 can be minimized. The ease of removal of the bulking device 16 may be desirable because new implants which better accommodate the changing anatomy of the patient during the progression of the patient's LES disfunction and/or age may be indicated.
In one embodiment, one or more attachment zones 28 may extend circumferentially around the bulking device 16. Alternatively, the tissue ingrowth surfaces 28 may extend axially along the length of the esophageal bulking device 16. Further, the attachment zones 28 can be provided in the form of spots or patches distributed around the surface of the esophageal bulking device 16.
The porosity of the cellular ingrowth regions 28 may range from about 20 μm to about 100.0 μm or greater. Desirably, the porosity of the cellular ingrowth regions 28 ranges from 20 μm to 50 μm and, in many embodiments, the porosity of the cellular ingrowth regions 28 ranges from 20 μm to 30 μm.
Suitable outer layer 27 and/or attachment surface 28 materials include polytetrafluoroethylene (PTFE), polyethylene terephthalate, polyester, polyurethane, silicone, Dacron, polypropylene knit, and other materials which will be apparent to those of skill in the art in view of the present disclosure. In one embodiment of the invention, the cellular ingrowth region 28 comprises PTFE having a 22 μm pore size. This porosity appears to permit shallow ingrowth into the esophageal bulking device 16 to prevent axial migration of the device 16 along tissue planes yet allows for relatively easy explant.
Delivery of the esophageal bulking device 16 below the mucosa can be accomplished in any of a variety of ways, as will be apparent to those of skill in the art in view of the disclosure herein. Delivery systems can be specially constructed or assembled from existing endoscopic and other surgical tools to accomplish the basic delivery steps.
In general, the delivery site for a particular patient is identified, such as by endoscopy and manometry. Tissue adjacent to the delivery site is preferably immobilized to permit a puncture or incision to be made. Immobilization of the esophageal lining may be accomplished by grasping the tissue utilizing forceps, such as those which may be advanced through a working channel on an endoscope. Alternatively, a vacuum may be applied to a lumen through an endoscope to immobilize the tissue.
Using counter-traction on the tissue applied by way of the tissue grasper or vacuum, the mucosa is pierced to enable insertion of the prosthesis. The mucosal layer may be pierced in a variety of ways, as will be recognized in the art. In accordance with one aspect of the present method, a needle is utilized to pierce the mucosa and create a blister by injecting a volume of fluid such as saline solution. Alternatively, an electrocautery cutter or any of a variety of sharp dissection tools may be utilized to pierce the mucosa and provide access to the submucosal area.
Once an aperture has been formed in the mucosa, a pouch or cavity is formed in the submucosa. The pouch may be formed by liquid infusion to enlarge the blister discussed above. Alternatively, any of a variety of blunt tools may be utilized to achieve a blunt dissection in the submucosa or between adjacent tissue planes to form a pouch for receiving the prosthesis. Alternatively, an inflation device, such as a balloon, may be specially shaped for insertion and inflation to separate submucosal tissue and provide a submucosal pouch.
Following formation of a submucosal pouch, one or more bulking devices 16 are introduced therein. The bulking device 16 may be inserted by way of a grasper, clamshell deployment device, or other tools. Depending upon the shape and compliancy of the bulking device 16, the bulking device 16 may be deployed from the distal end of a tubular element, such as by advancing an axially moveable core to push the prosthesis from the distal end of the tube. One or more pull elements such as wires, strings or tabs may be provided on the bulking device 16, so that a distally extending pull element may be advanced into the pouch under distal force using a grasper, or a second mucosal puncture inferior to the primary mucosal puncture may be provided through which to pull a pull element, thereby advancing the bulking device 16 inferiorly into the pouch.
Following placement of the bulking device 16 into the submucosal pouch, the mucosal opening closes naturally or can be closed using any of a variety of closure techniques. A conventional suture, ligating bands or staples or other clips, may be utilized endoscopically, as will be understood in the art. Alternatively, a topical glue or other adhesive patch may be utilized to close the opening in the mucosa.
Thus, referring to
The cavity may be formed entirely by the injection of saline or other injectable media, or may be formed into its final size using mechanical tools as discussed below.
Following blister formation, a small incision or access site 42 is provided as illustrated in
Following dilatation or manipulation of another pocket forming device, the balloon dilatation catheter 44 or other device is reduced in size and removed, thereby leaving a receiving cavity 46 for one or more bulking devices 16. The bulking device 16 may then be inserted within the cavity using any of a variety of delivery implements, the specific design of which will depend upon the size and configuration of the bulking device 16. Alternatively, the bulking device may be introduced into the cavity through a delivery lumen extending throughout the balloon catheter. The foregoing steps may be repeated for two or more positions around the circumference of the esophagus in the vicinity of the LES, as may be desired.
An alternate method of forming the cavity 46 is illustrated in
Referring to
The distal end construction illustrated in
The sidewall 52 extends between a proximal end 54 and a distal end 56. Distal end 56 preferably blunt, and may include a distally extending pliable nose or extension such as molded silicone, to provide an atraumatic surface. The cap 50 is provided with an opening 58, preferably on the side wall 52, for receiving tissue from the target site. In one embodiment, the opening 58 has an axial length of about 1.25 inches, and a width of about 0.28 inches. In this embodiment, a generally rectangular opening 58 is provided to facilitate introduction of an elongate bulking element into the target site. Other configurations for first opening 58 may be utilized, as is discussed below, depending upon the size and shape of the prosthesis.
A tissue stabilizing or limit surface 62 defines at least a portion of the wall of the cavity. In the illustrated embodiment, surface 62 is on the lateral face of a surface such as on a shelf or plate 60 positioned medially (towards the central longitudinal axis) from the first opening 58. Preferably, the tissue stabilizing surface 62 is provided with one or more apertures 64, which are in communication through the shelf 60 with a vacuum lumen 66 in the cap 50. Vacuum lumen 66 is adapted for coupling to a lumen in the endoscope or other medical device, so that a vacuum may be drawn on vacuum lumen 66.
The tissue stabilizing surface 62 cooperates with the tissue opening 58 to define a tissue receiving cavity 65 in the medical device. The overall shape and volume of the cavity 65 can be varied widely, depending upon the intended application. For example, tissue opening 58 can have a generally rectangular shape as in the illustrated embodiment. Alternatively, the tissue opening 58 can be in the form of an oval or ellipse, or circle, depending upon the length and width of the desired submucosal low pressure zone or prosthesis. In addition, the tissue stabilizing surface 62 can be concave in the direction of tissue opening 58 or generally planar as illustrated. In one embodiment, the tissue stabilizing surface 62 is in the form of a portion of the side wall of a cylinder, such that it has a substantially linear configuration in the axial direction and a radiused curve in the transverse cross-section. Generally conical or hemispherical configurations for tissue stabilizing surface 62 may also be provided, with an aperture 64 at the apex thereof or a plurality of apertures 64 positioned on the tissue stabilizing surface 62. The tissue stabilizing surface 62 may also be provided with friction enhancing structures, such as a plurality of ridges or grooves to minimize sliding of the submucosal tissue along the surface 62.
In use, tissue which is positioned adjacent the tissue opening 58 will be drawn into the tissue opening 58 and adjacent the tissue stabilizing surface 62 in response to application of vacuum through apertures such as the apertures 64. The tissue stabilizing surface 62 thus acts as a limit, to reproducibly control the amount of tissue drawn into the opening 58 in response to the vacuum.
The cap 50 may be provided at its proximal end 54 with a second opening 68. Second opening 68 is adapted to be coupled to an endoscope or other medical device. For this purpose, an attachment structure 70 such as an annular recess may be provided on the proximal end 54 to facilitate insertion of the distal end of an endoscope (not shown) therein. The cap 50 may be secured to the endoscope in any of a variety of ways, such as by threaded engagement, snap fit or other interference fit structures, adhesives, or other attachment techniques which will be known in the art.
When coupled to an endoscope, a viewing lens on the endoscope is preferably oriented in the cap 50 such that tissue which has advanced into the cavity 65 can be visualized through the endoscope optics. This may be accomplished by constructing the shelf 60 from a transparent material, and/or providing a viewing aperture 72 between the lens on the endoscope and the tissue opening 58.
A working channel on the endoscope is aligned with a deployment lumen 74. Deployment lumen 74 may be defined at least in part by an internal baffle wall 76. In the illustrated embodiment, the baffle 76 is inclined radially outwardly in the distal direction to taper the inside diameter of the deployment lumen 74 in the distal direction. This assist in guiding the deployment device (discussed in greater detail below) and possibly the cavity forming device into the tissue which has been drawn into the cavity 65. The deployment lumen 74 has a distal end 78. Deployment lumen 74 is oriented such that an elongate device which is advanced through deployment lumen 74 and out distal end 78 will extend at least partway across the tissue opening 58. A piercing device such as a needle, cautery tip or other cutting structure which is advanced through deployment lumen 74 will enter and travel beneath tissue which is brought into contact with tissue stabilizing surface 62.
Referring to
In the illustrated embodiment, a flexible tubular sheath 80 extends proximally from the distal end assembly 56. Tubular sheath 80 is preferably dimensioned to receive and closely fit a standard endoscope. For example, one common endoscope for use in the present invention has an outside diameter of about 9.8 mm. The corresponding lumen 120 in tubular sheath 80 has an inside diameter of about 11 mm and an axial length within the range of from about 60 cm to about 120 cm. Tubular sheath 80 may comprise any of a variety of polymeric materials which are conventional in the catheter manufacturing arts. The tubular sheath 80 may be integrally formed with or bonded to the side wall 52 of midsection 53 and other structural components of the distal end 56 assembly. In one embodiment, tubular sheath 80 comprises PVC, having a wall thickness of about 0.050″.
A proximally extending deployment lumen 74 is defined within a tubular wall 82. In this construction, the tubular wall 82 extends in parallel with at least a portion of the endoscope, so that the deployment catheter or other deployment device need not be advanced through a working channel in the endoscope. The deployment lumen 74 terminates in a distal end 78 which directs the deployment device or piercing device into tissue which has been drawn into the cavity 65. Proximally, the deployment lumen 74 may terminate in a manifold, which may additionally be provided with a flush port 128 if desired.
The central lumen 120 for receiving an endoscope extends between a distal end 122 in midsection 53 and a proximal endoscope seal 124. A distal tip 56 preferably extends beyond the midsection 53, to permit atraumatic introduction of the device. Distal tip 56 is preferably provided with a guidewire lumen 126, to facilitate over the wire placement. Guidewire lumen 126 can extend proximally throughout the length of the device, or exit at a proximal side port 127 along the side of the device such as at about the proximal end of the distal tip 56 section.
In one embodiment of the overtube illustrated in
Referring to
The proximal manifold 79 is further provided with a vacuum port 83. Vacuum port 83 is in communication with a vacuum lumen (not illustrated) extending throughout the length of flexible body 75, and communicating with the tissue cavity 65 through one or more apertures 64 as has been discussed.
The embodiment of the delivery device illustrated in
The deployment catheter 73 may be used in any of a variety of ways, and dimensions and materials may be modified to accommodate the specific intended use. For example, the deployment device 73 can be utilized to access a treatment site in the esophagus through either the nose or the mouth. Particularly in an application intended to be advanced through the nose, the distal end 56 is provided with an elongate tapered atraumatic tip to enable the device to deflect off the soft palate with minimal trauma. Distal tips for any of the
For either nasal or oral access, the tubular body 75 may have a diameter of within the range of from about 5 mm to about 20 mm, and an axial length within the range of from about 70 cm to about 120 cm. Tubular body 75 may be constructed in any of a variety of manners well known in the catheter construction arts. For example, much of the length of tubular body 75 may comprise a two lumen extrusion with additional lumen (e.g. a guidewire lumen) being provided if additional functionalities are desired. The extrusion may comprise any of a variety of materials such as HDPE, PTFE, nylon, acrylic, PVC and other polymers which are well known in the art. The distal end 56 and distal side wall 52 including the tissue cavity 65 may be separately formed and secured to the extrusion in any of a variety of ways, such as through heat melting, adhesive bonding and other techniques which are known in the art.
Referring to
The deployment device 90 may be constructed in any of a variety of ways which are known in the catheter construction arts. For example, either or both of the inner element 98 and outer tube 100 may be metal tubes such as hypotubes, dimensioned such that the inner element 98 is axially moveable within the outer tube 100. Alternatively, either or both of the inner element 98 and outer tube 100 may be polymeric extrusions. The inner element 98 may either be a tubular structure or a solid rod.
In an embodiment intended to advance through a deployment lumen 74 having an inside diameter of about 0.100″, the outer tube 100 has an outside diameter of no more than about 0.095″. In one embodiment, the inner element 98 comprises a stainless steel rod, and the outer tube 100 comprises polyimide tube. The deployment device 90 has an axial length within the range of from about 70 cm to about 100 cm, and, in the illustrated embodiment, about 100 cm.
Preferably, the length of axial travel of the inner element (e.g. push rod) 98 with respect to the outer tube 100 is sufficient to advance the distal pushing surface 108 to a position beyond the distal end 110 of the cavity 102. In an embodiment intended to deliver a hydrogel bulking device having (an unexpanded) diameter of about 2 mm and axial length of about 20 mm the deployment device 90 is constructed to permit the distal pushing surface 108 on plunger 104 to extend at least about 10 mm beyond the distal end 110 of the cavity 102. The present inventors have determined that permitting the plunger to extend beyond the distal end of the cavity 102 permits the deployment of semi-liquid or gel form bulking agents into a submucosal tissue tract while minimizing the likelihood that trailing threads of the bulking agent will extend proximally through the tissue access pathway upon proximal retraction of the deployment device 90.
In one embodiment, the distal end 96 is provided with a sharpened point 112 for piecing a tissue surface. In this embodiment, an outer protective sheath 150 may be axially moveably carried on the outer tube 100, such that distal advancement of the outer cover 114 will shield the distal pointed tip 112. In an alternative embodiment (
Referring to
Referring to
In the illustrated embodiment, an overtube handle or manifold 79 is provided with a sheath seal 154 and a scope seal 156 for sealingly receiving the delivery sheath and the endoscope as has been discussed.
The dilating trocar and sheath assembly allows the delivery of a prosthesis having a greater cross-sectional dimension than the initial puncture. For example, the needle 90 may be dimensioned to provide a 0.5 mm hole in the tissue, and then be used to introduce a volume of fluid submucosally to create a cavity, as is discussed elsewhere herein. The needle, dilator and sheath are then advanced into the cavity, providing a 2 to 3 mm channel into the submucosal plane. The dilator 152 and needle 90 assembly may thereafter be proximally withdrawn, so that the prosthesis 106 may be deployed through the sheath 150 into the preformed cavity. Following deployment of the prosthesis 106, the sheath 150 is proximally retracted from the tissue. Upon removal of the sheath 150, the tissue surrounding the tissue tract constricts back to a smaller cross section, thereby providing resistance to proximal migration of the deployed prosthesis 106.
In one application of the method of the present invention, the reflux repair system is positioned within the esophagus and tissue is drawn into the cavity 65 as has been discussed. A blebbing needle, generally within the range of from about 20 to about 25 gauge, and, in one embodiment, 23 gauge, is introduced into the tissue to create a cavity. Approximately 0.5 to about 5 cc of fluid, such as saline is introduced into the tissue. The blebbing fluid may additionally comprise any of a variety of additives such as antimicrobial compounds, contrast agents for visualization, antibiotics, lidocaine, epinephrine, hyaluronic acid, PEG, colorants or others as may desired. In an embodiment in which the blebbing needle is distinct from the dilating trocar assembly, the blebbing needle is thereafter retracted proximally from the site, and withdrawn from the overtube sheath 80.
A dilating trocar sheath assembly is thereafter advanced distally through the tissue tract, thereby increasing the diameter of the tissue tract from approximately equal to the blebbing needle, to a sufficient diameter to receive the sheath 150. Sheath 150 has an outside diameter within the range of from about 0.085 in. to about 0.095 in., and, in one embodiment, about 0.090 in. Once the sheath 150 is in position through the tissue tract and into the tissue cavity, the trocar tip 96 and dilator 152 assembly is proximally retracted to leave the sheath 150 in position to provide access to the tissue cavity. The prosthesis 106 is thereafter advanced through the sheath 150 and into the tissue cavity using the push rod 98.
The prosthesis 106 may be advanced using the push rod 98 directly through the sheath 150. Alternatively, a prosthesis delivery assembly may be provided, in which the prosthesis 106 is positioned within the distal end of a tubular delivery needle or cannula as has been discussed in connection with previous embodiments. This needle preferably has an inside diameter of at least about 1 mm, and, in one embodiment, about 2 mm, to retain an expandable prosthesis 106 therein. The delivery cannula carrying the prosthesis 106 and push rod 98 may be advanced through the sheath 150 and into the cavity. The distal end of the delivery needle is preferably positioned at the distal end of the cavity, and the delivery needle is proximally retracted while the push rod 98 is maintained in its axial position, thereby deploying the prosthesis 106 into the distal portion of the cavity. The delivery needle and push rod 98 may thereafter be retracted from the cavity, and the vacuum released to disengage the overtube sheath from the tissue surface. In an alternate application of the method, the prosthesis is carried in and deployed directly from the needle, and the sheath may be omitted.
Prior to disengaging the overtube sheath 80 from the tissue wall, the tissue tract may be sealed or plugged to further reduce the likelihood of migration of the prosthesis 106 from the cavity. This may be particularly desirable in an embodiment in which the prosthesis 106 is delivered in the form of a cure in place liquid or gel. The tissue tract may be plugged in any of a variety of ways, such as by injecting a collagen, wax or other plug. Alternatively, the tissue tract may be sutured or clipped, or sealed or filled with an adhesive with or without a patch.
As with previous embodiments of the method and devices, the prosthesis 106 deployed using the system illustrated in
Removal of the hydrogel or other implant can also be accomplished using mechanical explantation devices, such as any of a variety of biopsy tools or mechanical graspers. Removal can also be accomplished by applying pressure on tissue above a first end of the implant to cause the implant to advance in a second direction, i.e., by pressing the implant out. Depending upon the composition of the implant, it may also be dissolved or degraded in place, such as by the introduction of a solvent or initiator.
The deployment or delivery systems disclosed in
Concerning the first category, a variety of capsules and foams have already been disclosed herein. In addition, a variety of hydrogels may be used such as those disclosed in U.S. Pat. No. 4,943,618 issued Jul. 24, 1990 to Stoy et al., entitled Method for Preparing Polyacrylonitrile Copolymers by Heterogeneous Reaction of Polyacrylonitril Aquagel, and U.S. Pat. No. 5,252,692 issued Oct. 12, 1993 to Lovy et al. entitled Hydrophilic Acrylic Copolymers and Method of Preparation, the disclosures of both of which are incorporated in their entireties herein by reference. Preferably, a hydrogel or other material will be selected which has an expansion ratio on the order of at least about 100% and preferably in excess of 500%, particularly in the transverse direction. Thus, a hydrogel rod having a diameter of about 1 mm when positioned within the cavity 102 will preferably expand to a cross section of about 5 or 6 millimeters or greater in situ. Preferably, the hydrogel or other bulking media will exhibit a sufficient expansion rate that it will expand sufficiently to lock in place before migrating from the deployment site such as through the introduction tissue tract.
Another aspect of the present invention is the ability to introduce a bulking media in a fluid or gel form which possesses no inherent ability to achieve a predetermined shape, yet, when used with the devices of the present invention, will produce a bulking structure having a predetermined configuration. This is achieved through the interaction between the devices disclosed herein and the anatomy of the esophagus.
The central esophageal lumen is surrounded by a mucosa layer having a thickness on the order of from about 1.0 to about 2.0 mm. Below the mucosa is the submucosa, having a thickness on the order of about 0.5 to about 1 mm. Below the submucosa is a muscle layer having a variable thickness, generally on the order of about 2 mm to about 3 mm. When mucosa is drawn into the cavity on the delivery device of the present invention, a reproducible low pressure region is created in the submucosa which corresponds in shape to the shape of the mucosa which has been drawn into the cavity. The delivery channel directs a deployment needle or other device through the mucosa and directly into the low pressure region of the submucosa. Thus, in accordance with the present invention, a polymerizable or otherwise hardenable fluid or gel may be injected into the low pressure zone in the submucosa at the target site, and that fluid or gel will assume a shape which is strongly influenced by the shape of the opening 58 and depth of the cavity 65. In addition, the muscle layer is substantially unaffected by the application of vacuum to the mucosa using the devices disclosed herein, because the deployment lumen directs the deployment device generally in parallel to the muscle layer. This minimizes the risk of piercing the muscle layer beneath the submucosa. Among other complications from piercing the muscle layer, the aorta and vagus nerve are positioned closely outside of that layer.
Any of a variety of fluids or gels may be utilized, such as UV curable materials, heat or catalytically initiated polymerizable materials, and others which can be optimized through routine experimentation by those of ordinary skill in the art in view of the disclosure herein. Another useful class of bulking media includes biocompatible polymers which are soluble in a biocompatible solvent but insoluble in the submucosal tissue. The biocompatible solvent is soluble or dispersible in the tissue, such that the biocompatible solvent diffuses away from the biocompatible polymer in situ, thereby permitting the biocompatible polymer to precipitate, polymerize, or otherwise harden into a bulking mass. In one embodiment, the bulking media further includes a contrast agent, to permit visualization of the bulking mass during and following implantation of the bulking media. Examples of suitable bulking media are disclosed in U.S. Pat. No. 5,785,642, issued Jul. 28, 1998 to Wallace et al., entitled Methods for Treating Urinary Incontinence in Mammals, the disclosure of which is incorporated in its entirety herein by reference.
Although the foregoing invention has been disclosed in terms of certain preferred embodiments, other specific embodiments can be constructed in view of the disclosure herein without departing from the spirit of the scope of the present invention. Accordingly, the scope of the Applicant's invention is to be determined by reference to the attached claims, which are not limited to any of the particular embodiments disclosed herein.
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The first round in the Women's Draw is complete and we have already seen some surprises as well as some very solid play.
Here are some of the first round highlights from Flushing Meadows:
Probably the biggest shocker was the departure of 8th seed Caroline Wozniacki. It was clear that Wozniacki was not herself under the lights on Tuesday. Coming off of a knee injury prior to the Open, she made a number of unforced errors and looked to have problems moving around the court against Irina-Camelia Begu. She was eliminated 2-6, 2-6. Wozniacki looked to have re-injured the knee early in the second set as the trainer retaped it. But she was clearly not on her game and exits in the first round.
Serena Williams was on her game. She was focused and powerful and took little time to defeat big server CoCo Vandeweghe 6-1, 6-1. Picking up where she left off at the Olympics, Williams came up with big serves and solid ground strokes and took advantage of Vandeweghe's struggles on serve. The 4th seed moves on to face Maria Martinez Sanchez in the second round.
Meanwhile another American made some noise in the first round. Sloane Stephens upset veteran and 22nd seeded Fransesca Schiavone of Italy. Stephens has been tabbed as one to watch as her ranking has soared. She has a history of doing well early at Majors and today won in straight sets, 6-3, 6-4 over the former Majors Champion.
Unseeded Venus Williams had no problems in her opening round match against Bethanie Mattek-Sands. She won in straight sets 6-3, 6-1. After the match Williams was asked how she felt and responded, "I can't complain". She will face Angelique Kerber, the 6th seed who dispatched Anne Keothavong 6-2, 6-0. Kerber will be a real challenge for Williams.
Top seeded, Victoria Azarenka made quick work of Alexandra Panova 6-0, 6-1 to advance to the second round. The match took just 50 minutes as the top seed had 20 winners to her opponents 2.
Elsewhere, it was 3rd seeded Maria Sharapova who had very little difficulty in her first round match defeating Melinda Czink of Hungary in straight sets, 6-2, 6-2. She will face Lourdes Dominguez Lino in the second round as the former U.S. Open Champion looks for another Title.
Fan favorite and 23rd seed Kim Clijsters in her final U.S. Open advanced past 16 year old, Victoria Duval in Arthur Ashe Stadium. Duval won her way into the field as a USTA under 18 qualifier. Clijsters will retire after the Open and has a huge following in New York. She will face Laura Robson in the second round.
16th seeded Sabine Lisicki was upset by Sorana Cirstea 4-6, 6-2, 6-2. Lisicki struggled with her serve at times tossing in 8 double faults. She also had 42 unforced errors in the match which contributed to her defeat.


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Great article about the new features. Thank you for contributing for the db2 community, as always. I have one request, can you please brighten up the code in your posts? its very light and hard on eyes, especially when viewed in lower lights as I work for long hours in front of the computer.
DB2 10: Paging through result sets by value using row value comparisons
Comments (6) Visits (10574)
I have have been engaged in discussions on how to use DB2 for LUW for as long as I have been employed with IBM.
Until not too long ago, before I started blogging, the primary platform for such discussion was usenet.
And one of the very oldest debates I recall was with Bernard D.
For at least a decade he has been tirelessly trying to convince us to extend DB2 for LUW to support comparisons of "row value constructors" (rvc).
In fact the oldest record I can find on Google on this debate dates back to October 21, 2000.
Well, Bernard, this post is for you.
Now we need to find something else to talk about I guess.
The problem
In the past I have described various ways how to page through result sets using constructs such as LIMIT and OFFSET.
All of these methods have one thing in common: They are based on the absolute position of rows within a result set.
For example OFFSET 100 LIMIT 20 will retrieve 20 rows starting with the 100th row.
So, in order for DB2 to find the 100th row DB2 needs to count of the first 99 rows and discard them.
The farther down a result set you page the bigger the waste in CPU and I/O.
Let's have a look:
db2set DB2_
A look at the optimizer plan shows that there is little DB2 can do to minimize the rows read.
Rows RETURN ( 1) Cost I/O | 1 FILTER ( 2) 6.80181 1 | 10 FETCH ( 3) 6.79467 1 /-----+------\ 10 10 IXSCAN TABLE: ADMINISTRATOR ( 4) EMP 0.0211523 Q1 0 | 10 INDEX: ADMINISTRATOR EMPNAME Q1
Value based paging
A better way to do paging is to use the index not only to derive the order, but also the start key.
VARIABLE name VARCHAR(20); BEGIN SET :name = ' '; END; / SELECT * FROM emp
We can use the last retrieved value as a starting point for the next page:
BEGIN SET :name = 'Kruft'; END; / SELECT * FROM emp
The optimizer plan is much better now.
It allows us to find the first row efficiently:
Rows RETURN ( 1) Cost I/O | 3.33333 FETCH ( 2) 6.78901 1 /-----+------\ 3.33333 10 IXSCAN TABLE: ADMINISTRATOR ( 3) EMP 0.0177397 Q1 0 | 10 INDEX: ADMINISTRATOR EMPNAME Q1 ... 3) IXSCAN: (Index Scan) ... Predicates: ---------- 2) Start Key Predicate, Comparison Operator: Less Than (<) Subquery Input Required: No Filter Factor: 0.333333 Predicate Text: -------------- (? < Q1.NAME)
Now, I have been cheating here since the index is on two columns "NAME" and "FIRSTNAME".
If there were two or more employees named 'Kruft' we could have skipped one.
Traditional row wise paging
Here is how one can page using a multiple column start key in DB2 no matter what version:
VARIABLE firstname VARCHAR(20); BEGIN SET (:name, :firstname) = (' ', ' '); END; /
How would the predicate look like if we had three key parts? Lenghty ...
SELECT * FROM emp
The problem is that in older versions of DB2 the optimizer cannot figure out that this predicate maps to an index start key.
Therefore DB2 needed to fall back to a scan from the beginning of the index.
Since DB2 9.7.3 the optimizer is smart enough:
Rows RETURN ( 1) Cost I/O | 3.55556 TBSCAN ( 2) 6.79745 1 | 3.55556 SORT ( 3) 6.79697 1 | 3.55556 TBSCAN ( 4) 6.79574 1 | 10 TABLE: ADMINISTRATOR EMP Q1
This is not what we expected because I use dynamic SQL here!
In dynamic SQL DB2 does not see that the two references to :name are in fact the same values.
The following trick allows DB2 to see what we are up to.
It is generally useful whenever you must use the same parameter marker multiple times in a query.
SELECT emp.*
This is better! However the language we need to use to model the start key is quite ugly.
Row value comparison
Reaching back to high school math you may recall that the predicates we have used above to impose order are commonly used to compose order on tuples.
A tuple A is an ordered list of elements of the form (a1, a2, ... an).
A tuple A (a1, a2, ..an) is equal to a tuple B (b1, b2, bn) if and only if all the elements ai in A a re equal to the matching bi in B.
A is considered greater than B if a1 > b1 or (a1 = b1 and a2 > b2) or ... and so forth.
It is not surprising that this is also the ordering used in a multi column index or that imposed by an ORDER BY clause.
In math you can directly use comparison operators against tuples with no need to decompose them into the individual components.
You simply write: (a1, a2) > (b1, b2).
In SQL terms a set of elements compose not tuples but rows of course.
Thus the syntax composing a tuple is called a row value constructor (rvc).
You use it every time you insert a row into a table using the values clause.
Just at the beginning of this post we used a values clause with 10 row value constructors.
DB2 10 , finally, introduces the syntax to compare rows value constructors:
SELECT * FROM emp
So far we have always used a fixed number of rows to page forward.
But you can also use row value comparisons operators to set an upper bound or even both upper and lower.
VARIABLE startname VARCHAR(20); VARIABLE endname VARCHAR(20); VARIABLE startfirst VARCHAR(20); VARIABLE endfirst VARCHAR(20); BEGIN SET (:startname, :startfirst) = ('M', 'A'); SET (:endname , :endfirst ) = ('T', 'Z'); END; / SELECT * FROM emp
We are explicitly driving the index start/stop key here.
You can also use this syntax to write denser key lookups:
SELECT * FROM emp
There is no limit to the usage of the syntax.
It can even be used in JOIN On clauses
A cursor loop without a cursor
As I have been writing this article I have been wondering about an extreme case.
That is if I page through a result set one row at a time, then I should be able to write cursor that really isn't a cursor.
I'm not sure if it's good for anything, but here goes anyway:
VARIABLE sumsalary INTEGER;
So this anonymous block pages through the entire table one row at a time always getting the "next row" all without actually using a cursor.
I'm certainly very glad to see the feature in db2.
I loved reading this article, certainly took me a step forward but
I have an even more complex situation.
I have a grid, in an ASP.NET web application, to be filled with 20 rows from a table with more then 9 000 000 records.
I can't make a full read to the table (9 000 000 records) and paginate in the .NET side, it's too heavy and this application is used in a slow network.
But the problem is bigger when we consider that the user can choose the order of the results. By pressing mouse button on any grid column he defines the order to the results and obviously the paging must be built based on the order.
I already have a solution, a stored procedure containing dynamic SQL receiving the order, first record to fetch and number of records to fetch as parameters but it's pretty ugly.
I'm using ROW_NUMBER() OVER( ORDER BY ...) to order the results and create the numbered rows and then I use the WHERE clause with the row number to determine the first record to fetch and FETCH FIRST 'n' ROWS where 'n' is the parameter with the number of rows I want.
I'm talking about a DB2 database, on iSeries, built with CA 2E Advantage (also known as Synon), not built with DB2. So I don't have indexes or views.
Do you know any example like this? I would like to improve my solution to make it more simple and faster.
It is very fast, considering the other options but could it be better?


text: 87 Morozyuk (in) - Konoplyanka (out) (Ukraine) 85 D. Degen (in) - Stocker (out) (Switzerland) 76 Ben Khalifa (in) - A. Frei (out) (Switzerland) 75 Konoplyanka (Ukraine) scores! 74 Oleynik (in) - Yarmolenko (out) (Ukraine) 72 Von Bergen (in) - Lichtsteiner (out) (Switzerland) 66 Costanzo (in) - Schwegler (out) (Switzerland) 65 Stepanenko (in) - Mikhalik (out) (Ukraine) 62 A. Frei (Switzerland) scores! 48 Aliyev (Ukraine) scores! 46 Milevskiy (in) - Dević (out) (Ukraine) 46 Shaqiri (in) - Inler (out) (Switzerland) 46 Fernandes (in) - Barnetta (out) (Switzerland) 44 Barnetta (Switzerland) is shown a yellow card. 43 Aliyev (Ukraine) is shown a yellow card. 40 A. Frei (Switzerland) scores! 13 Mikhalik (Ukraine) is shown a yellow card. 2 Tymoshchuk (Ukraine) is shown a yellow card. Legend: Goals Own goal Converted penalty Missed penalty Red card Yellow card Second yellow card Substitution


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STDP4020DisplayPort receiver
- Active
The STDP4020 is a DisplayPort receiver IC for the secure reception of high-bandwidth uncompressed digital audio-video signals targeted for applications such as DTV, LCD monitor, projector, and other types of display systems. STDP4020 is a VESA DP 1.1a and eDP compliant device, implementing a single link DisplayPort input port comprising four main lanes, auxiliary channel, and HPD. In addition to the standard HBR (2.7 Gbps) and RBR (1.62 Gbps) speeds, this device supports "turbo" speed of 3.24 Gbps per lane with a total link bandwidth of 12.96 Gbps. The higher bandwidth provides unique benefits to users over other commercial DP receivers for embedded applications by offering additional margin to support higher color depth, resolution, and refresh rate. For example, STDP4020 supports FHD non-reduced blanking video (1080p 30-bit color per pixel) at 120 Hz, plus 7.1 Ch audio in two-box TV applications. The advanced equalizer built in this device offers guaranteed performance over long reach cables. The auxiliary channel in STDP4020 acts as a bidirectional communication link, supporting application-specific protocols such as MCCS, DDC, UART, IR, as well as the dedicated DisplayPort link training and device management functions.
The STDP4020 supports RGB and YCC video color formats with color depth of 12 (YCC 4:2:2 only), 10, and 8 bits. This device offers LVDS and LVTTL output interfaces configurable to map a wide range of display controller products. The Quad LVDS interface supports video signals up to 400 MHz pixel rate with flexible channel and lane swapping options. The 60-bit LVTTL output ports can be mapped to transfer video data either in two pixels per clock or single pixel per clock up to 300 MHz pixel rate. The STDP4020 also supports both compressed and uncompressed audio formats. The extracted audio signal is transferred on a digital audio output bus. This device comprises four I2S audio output ports, supporting up to 8 channel LPCM audio and a single wire SPDIF output for encoded audio. The STDP4020 features HDCP 1.3 content protection scheme with an embedded key option for secure reception of digital audio-video content. In addition, it supports the HDCP repeater function and, thus acts as an upstream receiver suitable for two-box TV and DP to HDMI/DVI converter applications.
The STDP4020 is configurable from an external host controller through I2C host interface. This device also includes general purpose inputs/outputs for controlling system components. The STDP4020 features a color space converter (RGB to YCC and YCC to RGB) for flexible interface with external video processing devices.
Errata Sheet
Key Features
- Enhanced DisplayPort® (DP) receiver
- DP 1.1a compliant
- Embedded DisplayPort (eDP) compliant
- 1, 2, or 4 lanes
- Higher bandwidth "Turbo mode" (3.24 Gbps per lane), supports:
- 1920 x 1080 (FHD) 120 Hz/10-bit color video standard timings and 7.1 Ch audio
- 2560 x 1600 (WQXGA), 2560 x 2048 (QSXGA) 60 Hz/10-bit color graphics and 7.1 Ch audio
- Interface compatibility with wide range of display controller ICs
- LVTTL (60 wide) and LVDS (quad bus) video interface
- 8-Ch I2S and SPDIF audio interface
- Robust AUX channel
- Link service, maintenance
- I2C-over-AUX (MCCS, DDC)
- IR, full duplex UART protocol
- Configurable through I2C host interface
- Supports HDCP 1.3 with on-chip keys
- HDCP repeater capability
- Acts as upstream receiver
- AUX to I2C bridge for EDID, MCCS pass through
- Spread spectrum on DisplayPort, LVDS, and TTL interfaces for EMI reduction
- Supports deep color and color format conversion
- RGB/YCC (4:4:4) – 10-bit color
- YCC (4:2:2/4:2:0) – 12-bit color
- RGB (4:4:4) to YCC (4:4:4) conversion and vice-versa
- Supports HBR/"Turbo" speed over HBR/RBR-rated long cables (15 m and more)
- Low power operation; 20 mW standby
- Package
- 164 LFBGA (12 x 12 mm / 0.8 mm)
- Power supply voltages
- 3.3 V I/O; 1.2 V core
Design ResourcesTop
Technical Documentation
Product Specifications
DB0844: DisplayPort receiver
Presentations & Training Material
DisplayPort: Next-generation digital A/V interface


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text:
I have few activities and from one activity I open another and that go back to the first one...
The point is onCreate is called ones , and onResume every time when the activity is show. For example when I close B that was previouslly started from A, the onResume is called but not onCreate....
my problem is that I do not want to run the onResume if it comes after onCreate, I want to run the code only if onCreate wasn't called
Is this possible to do WITHOUT static flag ?
is there some method or flag from android like comesAfterOnCreate ?
protected void onResume() {
//DO not run this code
//run the long task
I show a lot of answers with solution using static flag, Thanks to all of you for the effort and offering the help, but I was interested is there some method or something...


text:
Staff Reporter
Tehsildar says some promises are made in writing
Agitation enters the ninth day
PGCIL promises electrification of 151 villages within 18 months
BERHAMPUR: Rays of hope of pacification of agitating tribals in Chitrakonda in Malkangiri district came up on Thursday evening.
It was ninth day of the agitation by tribals who had continued to gherao the Chitrakonda tehsil office. Speaking over phone, the tehsildar of Chitrakonda, D.Gopalkrishna said the agitating tribals were provided some key promises in written form. The tribal leaders had started discussing the promises.
Mr Gopalkrishna was hopeful that the agitating tribals would call off their agitation and return to their villages.
Mr Gopalkrishna was mediating with the agitating tribals to pacify them. On Thursday the tehsil office received a faxed letter from the Power Grid Corporation of India Limited (PGCIL) with the promise that the PGCIL would electrify 151 villages of seven panchayats of cut-off areas of Chitrakonda reservoir within next 18 months. The tribal leaders were shown this written promise made by the PGCIL.
Collector's promise
Apart from it the district Collector had also promised procurement of five new motor launches for transportation to cut off villages of the reservoir. The tehsildar said these were the two major demands of agitating tribals. But in their memorandum they had a list of 11 demands. Malkangiri district Collector Nitin. B. Jawale had also promised to start efforts to fulfil the rest of the demands within next 30 days.
These demands included better public distribution system, medical facility, education etc.
The agitating tribals continued to gherao the Chitrakonda teshil office even on Thursday. The agitators are camping on open spaces near the tehsil office and the local market. The agitators include a large number of women and children. They are cooking their food and sleeping at the place.
Mr Gopalkrishna said electricity and communication were their major demands. It is an irony that these tribal families have not used electricity till date although they languished for decades for hydro-electricity projects.
These tribals were first displaced by Machkund Hydel Project which got completed in 1948. They were settled in Chitrakonda area. After that the Balimela Hydel project was constructed in 1964, for it the tribals were again shifted further downstream.
Since then these villages have remained water-locked by the Chitrakonda reservoir.


text: Publications Search Results Users may wish to consult What's Included in the Bibliography. Results 1 - 1 Results per page: 25 50 100 Sort by: Pub Date (newest) Title Recent Additions Author Clear All Pub. Year Citation 1991 Kiel, D.P., O'Sullivan, P., Teno, J.M., Mor, V. Health care utilization and functional status in the aged following a fall. Medical Care. 29, (3), 221-228. Full Text Options: DOI Worldcat Google Scholar Export Options: RIS EndNote XML [1]