text:
Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat
Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.
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This application is a continuation of copending U.S. patent application Ser. No. 11/037,548 entitled "Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat" filed on Jan. 18, 2005 which is a continuation-in-part of 1) U.S. patent application Ser. No. 10/829,917 entitled "Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat" filed on Apr. 21, 2004, 2) U.S. patent application Ser. No. 10/912,578 entitled "Implantable Device and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders" filed on Aug. 4, 2004 and 3) U.S. patent application Ser. No. 10/944,270 entitled "Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures" filed on Sep. 17, 2004, the entire disclosure of each such parent application being expressly incorporated herein by reference.FIELD OF THE INVENTION
The present invention relates generally to medical devices, systems and methods and more particularly to minimally invasive devices, systems and methods for treating sinusitis and other ear, nose & throat disorders.BACKGROUND OF THE INVENTION
Surgical treatments for sinusitis and other disorders of the ear, nose and throat have evolved slowly over the years. In current clinical practice, functional endoscopic sinus surgery (FESS) is often used to treat sinusitis or other disorders where drainage of mucous is impaired and/or chronic infections are present. In FESS, an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses. FESS procedures can be effective in the treatment of sinusitis and for the removal of tumors, polyps and other aberrant growths from the nose. Other endoscopic intranasal procedures have been used to remove pituitary tumors, to treat Graves disease (i.e., a complication of hyperthyroidism which results in protrusion of the eyes) and surgical repair of rare conditions wherein cerebrospinal fluid leaks into the nose (i.e., cerebrospinal fluid rhinorrhea).
In some instances, sinus and ENT surgery has been performed with the assistance of electronic navigation devices (i.e., "image-guided FESS"). In such image guided surgical procedures, integrated anatomical information is supplied through CT-scan images or other anatomical mapping data taken before the operation. Data from a preoperative CT scan or other anatomical mapping procedure is downloaded into a computer and special sensors known as localizers are attached to the surgical instruments. Thus, using the computer, the surgeon can ascertain, in three dimensions, the precise position of each localizer-equipped surgical instrument at any given point in time. This information, coupled with the visual observations made through the standard endoscope, can help the surgeon to carefully position the surgical instruments to avoid creating CSF leaks and to avoid causing damage to nerves or other critical structures.
Although FESS continues to be the gold standard therapy for severe sinuses, it has several shortfalls. Often patients complain of the post-operative pain and bleeding associated with the procedure, and a significant subset of patients remain symptomatic even after multiple surgeries. Since FESS is considered an option only for the most severe cases (those showing abnormalities under CT scan), a large population of patients exist that can neither tolerate the prescribed medications nor be considered candidates for surgery. Further, because the methodologies to assess sinus disease are primarily static measurements (CT, MRI), patients whose symptoms are episodic are often simply offered drug therapy when in fact underlying mechanical factors may play a significant role. To date, there is no mechanical therapy offered for these patients, and even though they may fail pharmaceutical therapies, no other course of action is indicated. This leaves a large population of patients in need of relief, unwilling or afraid to take steroids, but not sick enough to qualify for surgery.
Some experimental or investigational procedures have also been performed in an effort to treat sinusitis by methods that are less invasive and/or less damaging to ancillary tissues than FESS. For example, European physicians have reported the use of a hydrophilic guidewire and standard PTCA balloon catheter to treat restenosis of surgically created openings in diseased frontal sinuses and stenotic nasal conae. Göttmann, D., Strohm, M., Strecker, E. P., Karlsruhe, D. E., Balloon dilatation of Recurrent Ostial Oclusion of the Frontal Sinus, Abstract No. B-0453, European Congress of Radiology (2001); Strohm, M., Göttmann, D., Treatment of Stenoses of Upper Air Routes by Balloon Dilation, Proceeding of the 83rd Annual Convention of the Association of West German ENT Physicians (1999). The interventions described in this abstract were conducted only on frontal sinuses that had previously been surgically modified and nasal conae. These techniques were not reported to be ueable for the treatment of sinus ostia that has not previously been surcically altered or ostia of sinuses other than the easily accessible frontal sinuses. Also, in these these reported cases, standard vascular guidewires and angioplasty balloon catheters were used. The techniques described in these publications have not been widely adopted by ENT surgeons, possibly due to the fact that they lacked important novel improvements and modifications as described in this patent application and prior U.S. patent application Ser. Nos. 10/829,917, 10/912,578 and 10/944,270, of which this application is a continuation-in-part.
Other methods and devices for sinus intervention using dilating balloons have been disclosed in U.S. Pat. No. 2,525,183 (Robison) and United States Patent Publication No. 2004/0064150 A1 (Becker). For example, U.S. Pat. No. 2,525,183 (Robison) discloses an inflatable pressure device which can be inserted following sinus surgery and inflated within the sinus. The patent does not disclose device designs and methods for flexibly navigating through the complex nasal anatomy to access the natural ostia of the sinuses. The discussion of balloon materials is also fairly limited to thin flexible materials like rubber which are most likely to be inadequate for dilating the bony ostia of the sinus.
United States patent publication number 2004/0064150 A1 (Becker) discloses balloon catheters formed of a stiff hypotube to be pushed into a sinus. The balloon catheters have a stiff hypotube with a fixed pre-set angle that enables them to be pushed into the sinus. In at least some procedures wherein it is desired to position the balloon catheter in the ostium of a paranasal sinus, it is necessary to advance the balloon catheter through complicated or tortuous anatomy in order to properly position the balloon catheter within the desired sinus ostium. Also, there is a degree of individual variation in the intranasal and paranasal anatomy of human beings, thus making it difficult to design a stiff-shaft balloon catheter that is optimally shaped for use in all individuals. Indeed, rigid catheters formed of hypotubes that have pre-set angles cannot be easily adjusted by the physician to different shapes to account for individual variations in the anatomy. In view of this, the Becker patent application describes the necessity of having available a set of balloon catheters, each having a particular fixed angle so that the physician can select the appropriate catheter for the patient's anatomy. The requirement to test multiple disposable catheters for fit is likely to be very expensive and impractical. Moreover, if such catheter are disposable items (e.g., not sterilizable and reusable) the need to test and discard a number of catheters before finding one that has the ideal bend angle could be rather expensive.
The prior art has not provided catheters, devices, systems and methods that are optimal for minimally invasive treatment of sinusitis, mucocysts, tumors, infections, hearing disorders, fractures, choanal atresia or other conditions of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat or mouth structures.SUMMARY OF THE INVENTION
In general, the present invention provides methods, devices and systems for diagnosing and/or treating sinusitis, mucocysts, tumors, infections, hearing disorders, fractures, choanal atresia or other conditions of the paranasal sinuses, Eustachian tubes, llachrymal ducts, ducts of salivary glands and other ear, nose, throat or mouth structures.
In accordance with the present invention, there are provided methods wherein one or more flexible catheters or other flexible elongate devices as described herein are inserted in to the nose, nasopharynx, paranasal sinus, Eustachian tubes, middle ear, lachrymal ducts, ducts of salvary glands or other anatomical passageways of the ear, nose, throat or mouth to perform an interventional or surgical procedure. Examples of procedures that may be performed using these flexible catheters or other flexible elongate devices include but are not limited to: delivering contrast medium; performing an imaging study, delivering a therapeutically effective amount of a therapeutic substance; implanting a stent or a tissue remodeling device, substance delivery implant or other therapeutic apparatus; cutting, ablating, debulking, cauterizing, heating, dilating or otherwise modifying tissue such as nasal polyps, abberant or enlarged tissue, abnormal tissue, etc.; grafting or implanting cells or tissue; reducing, setting, affixing or otherwise treating a fracture; delivering a gene or gene therapy preparation; cutting, ablating, debulking, cauterizing, heating, freezing, lasing, forming an osteotomy or trephination in or otherwise modifying bony or cartilaginous tissue within paranasal sinus, nasopharynx, Eustachian tube, middle ear, Lachrymal duct or elsewhere within the ear, nose, throat or mouth; remodeling or changing the shape, size or configuration of a sinus ostium or other anatomical structure that affects drainage from one or more paranasal sinuses; removing puss or aberrant matter from the paranasal sinus or elsewhere within the nose; scraping or otherwise removing cells that line the interior of a paranasal sinus; removing all or a portion of a tumor; removing a polyp; delivering histamine, an allergen or another substance that causes secretion of mucous by tissues within a paranasal sinus to permit assessment of drainage from the sinus etc.
Still further in accordance with the invention, there are provided novel access, stabilizing and occluding devices. They may be used to facilitate insertion of working devices such as endoscopes, guidewires, catheters (e.g. balloon catheters), tissue cutting or remodeling devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc. into the paranasal sinuses and other structures in the ear, nose, throat or mouth for performing some or all of the procedures described herein.
Still further in accordance with the invention, there are presented several modalities for navigation and imaging of the interventional devices within the nose, nasopharynx, paranasal sinuses, Eustachian tubes, middle ear, lachrymal ducts, ducts of salvary glands or other anatomical passageways of the ear, nose, throat or mouth using endoscopic, fluoroscopic, radiofrequency localization, electromagnetic and other radiative energy based imaging and navigation modalities. These imaging and navigation technologies may also be referenced by computer directly or indirectly to pre-existing or simultaneously created 3-D or 2-D data sets which help the doctor place the devices within the appropriate region of the anatomy.
Still further in accordance with the invention, there are provided methods for improving drainage from a paranasal sinus that has a natural ostium that has not previously been surgically altered, said method comprising the steps of: A) providing an elongate guide (e.g., a wire, rod, probe, guidewire, flexible member, malleable member, tube, cannula, catheter, stylets, etc.) and a dilator (e.g., a dilation catheter, balloon catheter, expandable member, etc.); B) advancing the elongate guide to a position within or near the ostium; C) using the elongate guide to advance the dilatior to a position where the dilator is within the ostium; and D) using the dilator to dilate the natural ostium. The dilation of the natural ostium may, in at least some cases, result in breaking or rearrangement of bone that underlies the mucosa of the ostium.
Still further in accordance with the invention, there is provided a method for treating a mucocyst or other or other flowable-substance-containing structure located within a paranasal sinus, said method comprising the steps of A) providing a penetrator that is useable to form an opening in the mucocyst or other flowable-substance-containing structure; B) providing a compressor useable to compress the mucocyst or other flowable-substance-containing structure after an opening has been formed therein by the penetrator such that its contents will be forced out of the opening formed by the penetrator; C) advancing the penetrator into the paranasal sinus and using the penetrator to form an opening in the mucocyst or other flowable-substance-containing structure; and D) positioning the compressor in the paranasal sinus and using the compressor to compress the mucocyst or other flowable-substance-containing structure such that its contents will be forced out of the opening formed by the penetrator.
Still further in accordance with the invention, there is provided a method for dilating a Eustachian tube in a human or animal subject, said method comprising the steps of. A) providing a a guide member (e.g., a guidewire) that is insertable through the nose and is advanceable into the Eustachian tube through the pharyngeal ostium of the Eustachian tube and a dilator that is advanceable over the guidewire and useable to dilate the Eustachian tube; B) inserting the guidewire into the Eustachian tube; C) advancing the dilator over the guide member and into the Eustachian tube; and D) using the dilator to dilate the Eustachian tube. In some embodiments of this method, the guide member (e.g., guidewire) may have an anchor (e.g., a balloon) for holding the guide member in a substantially fixed position within the Eustachian tube, thereby guarding against inadvertent advancement of the guide member or dilation catheter into the middle ear as may injure the bones of the middle ear. In some embodiments, marker(s) such as radiopaque markers may be provided on the guide member and/or may be inserted into the adjacent ear canal next to the tympanic membrane to allow the operator to clearly view the location at which the Eustachian tube enters the middle ear, thereby further guarding against inadvertent advancement of the device(s) into the middle ear.
Still further in accordance with the invention, there is provided a method for modifying a bony structure within the nose or paranasal sinus human or animal subject, said method comprising the steps of: A) providing a direct viewing apparatus (e.g., a scope, rigid scope, flexible scope, camera, video camera, intranasal camera similar to an intraoral camera but sized for insertion into the nares or nasal cavity); B) inserting the direct viewing apparatus into the nose; C) advancing a guide device to a first location within the nasal cavity or paranasal sinus under direct viewing using the direct viewing apparatus; D) providing an indirect viewing apparatus (e.g., an imaging device, fluoroscope, fluoroscope with C-arm, magnetic resonance imaging device, tomographic device, CT scanner, electromagnetic navigational and/or guidance system, PET scanner, combination CT/PET scanner and optical coherence tomography device, etc.); E) advancing a working device (e.g., an endoscope, wire, probe, needle, catheter, balloon catheter, dilation catheter, dilator, balloon, tissue cutting or remodeling device, suction or irrigation device, imaging device, sizing device, biopsy device, image-guided device containing sensor or transmitter, electrosurgical device, energy emitting device such as laser, rf, etc., device for injecting diagnostic or therapeutic agent, device for implanting other articles such as stents, substance eluting or delivering device, implant, etc.) over the guide device to a second location location within the nasal cavity or paranasal sinus, under indirect viewing using the direct viewing apparatus; and F) using the working device to perform a therapeutic or diagnostic procedure.
Still further in accordance with the invention, there is provided a method for determining the position of a device within the body of a human or animal subject, said method comprising the steps of A) providing a device having an electromagnetic element (e.g., a sensor or electromagnetic coil) thereon; B) providing a plurality of fiducial markers which emit electromagnetic energy and an attachment substance or apparatus for removably attaching the fiducial markers to teeth, bones or other anatomical structures; C) using the attachment substance or apparatus to removably attach the fiducial markers to teeth, bones or other anatomical structures of the subject's body; D) performing an imaging procedure to obtain an image of a portion of the subject's body including the fiducial markers; and, thereafter, E) advancing the device into the subject's body and detecting the electromagnetic element on the device as well as the electromagnetic energy emitted by the fiducial markers; and F) using the image obtained in Step D and the information detected in Step E to determine the current position of the device within the subject's body.
Further aspects, details and embodiments of the present invention will be understood by those of skill in the art upon reading the following detailed description of the invention and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 3A-3D′ show embodiments of stabilizing members comprising an adhesive element.
FIGS. 24A′-24A″″ show a method of creating drainage channels for sinus secretions in Ethmoid sinus.
The following detailed description, the accompanying drawings and the above-set-forth Brief Description of the Drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description, the accompanying drawings and the above-set-forth Brief Description of the Drawings do not limit the scope of the invention in any way.
A number of the drawings in this patent application show anatomical structures of the ear, nose and throat. In general, these anatomical structures are labeled with the following reference letters:
- 1 Suction pump for delivering a controlled amount of negative pressure or vacuum to a suction device,
- 2. Irrigation pump to deliver saline, antibiotic solution or other suitable irrigation medium,
- 3. Power module to supply power to drills or other electrical devices,
- 4. Storage modules for storing instruments, medications etc.,
- 5. Energy delivery module to provide radiofrequency, laser, ultrasound or other therapeutic energy to a surgical device,
- 6. Fluoroscope, MRI, CT, Video, Endoscope or Camera or other imaging modules to connect or interact with devices used during various diagnostic or therapeutic procedures,
- 7. Display module e.g. a LCD, CRT or Holographic screen to display data from various modules such as an endoscope, fluoroscope or other data or imaging module,
- 8. Remote control module to enable an operator to control one or more parameters of one or more functional modules 18,
- 9. Programmable Microprocessor that can store one or more operation settings for one or more functional modules 18 etc., and
- 10. Stabilization device for holding various apparatuses during the procedure which may include a stabilization arm, table, clip, intranasal or extranasal inflatable support or robotically controlled apparatus,
- 11. Rotary drive module for rotating rotatable device such as a drill or auger (e.g., a motor having a rotation drive shaft or drive cable attached thereto.
One or more functional modules 18 may be connected to the working device 10. Instrument console module 16 can be controlled by console control means 20, e.g. a foot pedal controller, a remote controller etc. Instrument console 16 may be fitted with wheels to enable an operator to change the position of the instrument console 16 in an operating area. In one embodiment, instrument console module 16 and C-arm fluoroscope 14 are integrated in a single unit.
Stabilizing member 102 may be oriented to stabilizing device 100 in a variety of orientations. Also, the stabilizing member can be used to stabilize more than one working device.
- Foam materials such as polyurethane foam, polyvinyl chloride foam, Thermal-Reactive Foam™ etc.,
- Inflatable members such as compliant or non-compliant balloons,
- Moldable materials such as silicone rubber or wax,
- Metals such as stainless steel or super-elastic or shape memory metals such as Nitinol
- Thermoplastic elastomers such as block copolymers e.g. styrene-butadiene-styrene (SBS) rubber or ionomers etc.
The stabilizing members may be pre-molded to a predefined shape.
The inflatable occluding member may be made of variety of shapes.
The inflatable occluding member may comprise a variety of surface features. For example,
FIGS. 3A-3D′ show embodiments of stabilizing members comprising an adhesive element.
Stabilizing member 200 may be used to stabilize one or more working devices.
Any diagnostic or therapeutic device disclosed herein may comprise one or more malleable regions. For example,
The hypotubes disclosed above may be malleable or non-malleable. They may also comprise one or more bent or angled regions. For example,
In this example, the locating mechanism was a locator balloon. Other examples of locating device are deployable elements such as wire meshes, radially projecting wires, deployable devices located on guidewires (e.g. balloons, wire meshes etc.), devices deployed on pull-elements (e.g. radially expandable elements etc.) etc.
Such a combination of an anchoring device and a working device inserted along the anchoring device can be used for a variety of other methods and devices disclosed herein for treating anatomical openings such as ostia of paranasal sinuses, ostia of lachrymal ducts, ducts of salvary glands, Eustachian tubes and other ear, nose, throat or mouth structures etc.
FIGS. 24A′-24A″″ show a method of creating drainage channels for sinus secretions in Ethmoid sinus. In
Examples of diagnostic or therapeutic agents that can be delivered by the catheters in
Similarly, other embodiments of drilling devices may be used to puncture, remodel or change the shape, size or configuration of anatomical structures such as paranasal sinuses, Eustachian tubes, middle ear, nasopharynx, Lachrymal ducts or other anatomical regions in the ear, nose, throat or mouth. Such drilling devices may comprise for example elements for ablation or delivery of energy such as laser, RF, thermal shock waves etc.
The various devices and methods disclosed herein may be used in conjunction with various surgical navigations systems.
Other image guided surgery systems such as infrared sensor based systems e.g. Stryker Leibinger® Navigation System can also be used in conjunction with one or more methods or devices disclosed herein.
Some nonlimiting examples of antimicrobial agents that may be used in this invention include acyclovir, amantadine, aminoglycosides (e.g., amikacin, gentamicin and tobramycin), amoxicillin, amoxicillin/clavulanate, amphotericin B, ampicillin, ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime, cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol, clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet, ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole, ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin, penicillin G, pentamidine, piperacillin/tazobactam, rifampin, quinupristin-dalfopristin, ticarcillin/clavulanate, trimethoprim/sulfamethoxazole, valacyclovir, vancomycin, mafenide, silver sulfadiazine, mupirocin (e.g., Bactroban Nasal®, Glaxo SmithKline, Research Triangle Park, N.C.), nystatin, triamcinolone/nystatin, clotrimazole/betamethasone, clotrimazole, ketoconazole, butoconazole, miconazole, tioconazole, detergent-like chemicals that disrupt or disable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride, menfegol, and N-docasanol); chemicals that block microbial attachment to target cells and/or inhibits entry of infectious pathogens (e.g., sulphated and sulponated polymers such as PC-515 (carrageenan), Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPA gel) that prevent retroviruses from replicating in the cells; genetically engineered or naturally occurring antibodies that combat pathogens such as anti-viral antibodies genetically engineered from plants known as "plantibodies;" agents which change the condition of the tissue to make it hostile to the pathogen (such as substances which alter mucosal pH (e.g., Buffer Gel and Acidform), non-pathogenic or "friendly" microbes that cause the production of hydrogen peroxide or other substances that kill or inhibit the growth of pathogenic microbes (e.g., lactobacillus); antimicrobial proteins or peptides such as those described in U.S. Pat. No. 6,716,813 (Lin et al.) which is expressly incorporated herein by reference or antimicrobial metals (e.g., colloidal silver).
Additionally or alternatively, in some applications where it is desired to treat or prevent inflammation the substances delivered in this invention may include various steroids or other anti-inflammatory agents (e.g., nonsteroidal anti-inflammatory agents or NSAIDS), analgesic agents or antipyretic agents. For example, corticosteroids that have previously administered by intranasal administration may be used, such as beclomethasone (Vancenase® or Beconase®), flunisolide (Nasalide®), fluticasone proprionate (Flonase®), triamcinolone acetonide (Nasacort®), budesonide (Rhinocort Aqua®), loterednol etabonate (Locort) and mometasone (Nasonex®). Other salt forms of the aforementioned corticosteroids may also be used. Also, other non-limiting examples of steroids that may be useable in the present invention include but are not limited to aclometasone, desonide, hydrocortisone, betamethasone, clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone, prednicarbate; amcinonide, desoximetasone, diflorasone, fluocinolone, fluocinonide, halcinonide, clobetasol, augmented betamethasone, diflorasone, halobetasol, prednisone, dexamethasone and methylprednisolone. Other anti-inflammatory, analgesic or antipyretic agents that may be used include the nonselective COX inhibitors (e.g., salicylic acid derivatives, aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal, sulfasalazine and olsalazine; para-aminophenol derivatives such as acetaminophen; indole and indene acetic acids such as indomethacin and sulindac; heteroaryl acetic acids such as tolmetin, dicofenac and ketorolac; arylpropionic acids such as ibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofen and oxaprozin; anthranilic acids (fenamates) such as mefenamic acid and meloxicam; enolic acids such as the oxicams (piroxicam, meloxicam) and alkanones such as nabumetone) and Selective COX-2 Inhibitors (e.g., diaryl-substituted furanones such as rofecoxib; diaryl-substituted pyrazoles such as celecoxib; indole acetic acids such as etodolac and sulfonanilides such as nimesulide)
Additionally or alternatively, in some applications, such as those where it is desired to treat or prevent an allergic or immune response and/or cellular proliferation, the substances delivered in this invention may include a) various cytokine inhibitors such as humanized anti-cytokine antibodies, anti-cytokine receptor antibodies, recombinant (new cell resulting from genetic recombination) antagonists, or soluble receptors; b) various leucotriene modifiers such as zafirlukast, montelukast and zileuton; c) immunoglobulin E (IgE) inhibitors such as Omalizumab (an anti-IgE monoclonal antibody formerly called rhu Mab-E25) and secretory leukocyte protease inhibitor) and d) SYK Kinase inhibitoers such as an agent designated as "R-112" manufactured by Rigel Pharmaceuticals, Inc, or South San Francisco, Calif.
Additionally or alternatively, in some applications, such as those where it is desired to shrink mucosal tissue, cause decongestion or effect hemostasis, the substances delivered in this invention may include various vasoconstrictors for decongestant and or hemostatic purposes including but not limited to pseudoephedrine, xylometazoline, oxymetazoline, phenylephrine, epinephrine, etc.
Additionally or alternatively, in some applications, such as those where it is desired to facilitate the flow of mucous, the substances delivered in this invention may include various mucolytics or other agents that modify the viscosity or consistency of mucous or mucoid secretions, including but not limited to acetylcysteine (Mucomyst™, Mucosil™) and guaifenesin.
In one particular embodiment, the substance delivered by this invention comprises a combination of an anti-inflammatory agent (e.g. a steroid or an NSAID) and a mucolytic agent.
Additionally or alternatively, in some applications such as those where it is desired to prevent or deter histamine release, the substances delivered in this invention may include various mast cell stabilizers or drugs which prevent the release of histamine such as cromolyn (e.g., Nasal Chrom®) and nedocromil.
Additionally or alternatively, in some applications such as those where it is desired to prevent or inhibit the effect of histamine, the substances delivered in this invention may include various antihistamines such as azelastine (e.g., Astylin®), diphenhydramine, loratidine, etc.
Additionally or alternatively, in some embodiments such as those where it is desired to dissolve, degrade, cut, break or remodel bone or cartilage, the substances delivered in this invention may include substances that weaken or modify bone and/or cartilage to facilitate other procedures of this invention wherein bone or cartilage is remodeled, reshaped, broken or removed. One example of such an agent would be a calcium chelator such as EDTA that could be injected or delivered in a substance delivery implant next to a region of bone that is to be remodeled or modified. Another example would be a preparation consisting of or containing bone degrading cells such as osteoclasts. Other examples would include various enzymes of material that may soften or break down components of bone or cartilage such as collagenase (CGN), trypsin, trypsin/EDTA, hyaluronidase, and tosyllysylchloromethane (TLCM).
Additionally or alternatively, in some applications, the substances delivered in this invention may include other classes of substances that are used to treat rhinitis, nasal polyps, nasal inflammation, and other disorders of the ear, nose and throat including but not limited to anti-cholinergic agents that tend to dry up nasal secretions such as ipratropium (Atrovent Nasal®), as well as other agents not listed here.
Additionally or alternatively, in some applications such as those where it is desired to draw fluid from polyps or edematous tissue, the substances delivered in this invention may include locally or topically acting diuretics such as furosemide and/or hyperosmolar agents such as sodium chloride gel or other salt preparations that draw water from tissue or substances that directly or indirectly change the osmolar content of the mucous to cause more water to exit the tissue to shrink the polyps directly at their site.
Additionally or alternatively, in some applications such as those wherein it is desired to treat a tumor or cancerous lesion, the substances delivered in this invention may include antitumor agents (e.g., cancer chemotherapeutic agents, biological response modifiers, vascularization inhibitors, hormone receptor blockers, cryotherapeutic agents or other agents that destroy or inhibit neoplasia or tumorigenesis) such as; alkylating agents or other agents which directly kill cancer cells by attacking their DNA (e.g., cyclophosphamide, isophosphamide), nitrosoureas or other agents which kill cancer cells by inhibiting changes necessary for cellular DNA repair (e.g., carmustine (BCNU) and lomustine (CCNU)), antimetabolites and other agents that block cancer cell growth by interfering with certain cell functions, usually DNA synthesis (e.g., 6 mercaptopurine and 5-fluorouracil (5FU), antitumor antibiotics and other compounds that act by binding or intercalating DNA and preventing RNA synthesis (e.g., doxorubicin, daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin) plant (vinca) alkaloids and other anti-tumor agents derived from plants (e.g., vincristine and vinblastine), steroid hormones, hormone inhibitors, hormone receptor antagonists and other agents which affect the growth of hormone-responsive cancers (e.g., tamoxifen, herceptin, aromatase ingibitors such as aminoglutethamide and formestane, triazole inhibitors such as letrozole and anastrazole, steroidal inhibitors such as exemestane), antiangiogenic proteins, small molecules, gene therapies and/or other agents that inhibit angiogenesis or vascularization of tumors (e.g., meth-1, meth-2, thalidomide), bevacizumab (Avastin), squalamine, endostatin, angiostatin, Angiozyme, AE-941 (Neovastat), CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P), SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, IM862, TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha, interleukin-12 (IL-12) or any of the compounds identified in Science Vol. 289, Pages 1197-1201 (Aug. 17, 2000) which is expressly incorporated herein by reference, biological response modifiers (e.g., interferon, bacillus calmette-guerin (BCG), monoclonal antibodies, interluken 2, granulocyte colony stimulating factor (GCSF), etc.), PGDF receptor antagonists, herceptin, asparaginase, busulphan, carboplatin, cisplatin, carmustine, cchlorambucii, cytarabine, dacarbazine, etoposide, flucarbazine, fluorouracil, gemcitabine, hydroxyurea, ifosphamide, irinotecan, lomustine, melphalan, mercaptopurine, methotrexate, thioguanine, thiotepa, tomudex, topotecan, treosulfan, vinblastine, vincristine, mitoazitrone, oxaliplatin, procarbazine, streptocin, taxol, taxotere, analogs/congeners and derivatives of such compounds as well as other antitumor agents not listed here.
Additionally or alternatively, in some applications such as those where it is desired to grow new cells or to modify existing cells, the substances delivered in this invention may include cells (mucosal cells, fibroblasts, stem cells or genetically engineered cells) as well as genes and gene delivery vehicles like plasmids, adenoviral vectors or naked DNA, mRNA, etc. injected with genes that code for anti-inflammatory substances, etc., and, as mentioned above, osteoclasts that modify or soften bone when so desired, cells that participate in or effect mucogenesis or ciliagenesis, etc.
Additionally or alternatively to being combined with a device and/or a substance releasing modality, it may be ideal to position the device in a specific location upstream in the mucous flow path (i.e. frontal sinus or ethmoid cells). This could allow the deposition of fewer drug releasing devices, and permit the "bathing" of all the downstream tissues with the desired drug. This utilization of mucous as a carrier for the drug may be ideal, especially since the concentrations for the drug may be highest in regions where the mucous is retained; whereas non-diseased regions with good mucous flow will be less affected by the drug. This could be particularly useful in chronic sinusitis, or tumors where bringing the concentration of drug higher at those specific sites may have greater therapeutic benefit. In all such cases, local delivery will permit these drugs to have much less systemic impact. Further, it may be ideal to configure the composition of the drug or delivery system such that it maintains a loose affinity to the mucous permitting it to distribute evenly in the flow. Also, in some applications, rather than a drug, a solute such as a salt or other mucous soluble material may be positioned at a location whereby mucous will contact the substance and a quantity of the substance will become dissolved in the mucous thereby changing some property (e.g., pH, osmolarity, etc) of the mucous. In some cases, this technique may be used to render the mucous hyperosmolar so that the flowing mucous will draw water and/or other fluid from polyps, edematous mucosal tissue, etc., thereby providing a drying or desiccating therapeutic effect.
Additionally or alternatively to substances directed towards local delivery to affect changes within the sinus cavity, the nasal cavities provide unique access to the olfactory system and thus the brain. Any of the devices and methods described herein may also be used to deliver substances to the brain or alter the functioning of the olfactory system. Such examples include, the delivery of energy or the deposition of devices and/or substances and/or substance delivering implant(s) to occlude or alter olfactory perception, to suppress appetite or otherwise treat obesity, epilepsy (e.g., barbiturates such as phenobarbital or mephoobarbital; iminostilbenes such as carbamazepine and oxcarbazepine; succinimides such as ethylsuximide; valproic acid; benzodiazepines such as clonazepam, clorazepate, diazepam and lorazepam, gabapentin, lamotrigine, acetazolamide, felbamate, levetiraceam, tiagabine, topiramate, zonisamide, etc.), personality or mental disorders (e.g., antidepressants, antianxiety agents, antipsychotics, etc.), chronic pain, Parkinson's disease (e.g., dopamine receptor agonists such as bromocriptine, pergolide, ropinitrol and pramipexole; dopamine precursors such as levodopa; COMT inhibitors such as tolcapone and entacapone; selegiline; muscarinic receptor antagonists such as trihexyphenidyl, benztropine and diphenhydramine) and Alzheimer's disease, Huntington's disease or other dementias, disorders of cognition or chronic degenerative diseases (e.g. tacrine, donepezil, rivastigmine, galantamine, fluoxetine, carbamazepine, clozapine, clonazepam and proteins or genetic therapies that inhibit the formation of beta-amyloid plaques), etc.
The working element need not necessarily be a substance delivery reservoir 3322. For example, another type of working element useable in this invention is a laser device. In one embodiment, the laser device may comprise an optical fiber that delivers laser energy through the distal region of the optical fiber. Typical examples of lasers that can be used in the present invention are Nd:YAG lasers, Ho:NAG lasers, short pulsed laser systems such as excimer lasers (wavelength: 308 nm, pulse length full width at half maximum height: 60 ns), dye lasers (wavelength: 504 nm, pulse length full width at half maximum height: 1200 ns), tunable die lasers, KTP lasers, argon lasers, Alexandrite lasers (wavelength: 755 nm, pulse length full width at half maximum height: 300-500 ns) etc. Such a laser device may also be used in conjunction with or as a part of any method, system or device disclosed in this patent application for laser-assisted ablation or cutting, laser-assisted cauterization or other laser-assisted methods of treating sinusitis, mucocysts, tumors, polyps, occlusions, obstructions, edema or other conditions of the paranasal sinuses, Eustachian tubes, Lachrymal ducts, salivary glands and other hard or soft ear, nose, throat or mouth structures.
Such devices, systems and methods may also be used for performing other diagnostic or therapeutic procedures of Eustachian tubes, tympanums and middle ear structures. Examples of such procedures are biopsies, microendoscopy of the Eustachian tube and the middle ear structures, diagnosis and/or treatment of roundwindow ruptures, auditory-ossicle dislocations after tympanoplasty, prothesis dislocation after stapeclotomy, neuroradiologically undetectable liquorrhea caused by otobasal fractures, progressive disorders of the sound-conducting apparatus, Dysplasia of the ear, chronic otitis media mesotympanalis, cholesteatoma, presurgical evaluation of pathologic findings of both the mucosal lining and the ossicular chain, epitympanic retraction pockets of the ear drum, all chronic and recurrent ventilation or drainage disorders of Eustachian tubes etc.
One or more flexible regions especially flexible distal regions on the diagnostic or therapeutic devices disclosed herein may comprise bending or deflecting elements. Examples of such bending or deflecting elements are one or more pull wires etc. made of suitable materials such as stainless steel flat wire etc.
The abovementioned devices and methods may also be used for diagnosing or treating other conditions caused by narrowing or blockage of structures in the ear, nose, throat or mouth such as choanal atresia.
Various devices described herein such as catheters may comprise one or more lumens such as end-to-end lumens, zipper lumens, rapid exchange lumens, parallel lumen surrounded by a jacket etc.
It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.
1. A device for treating a mucocyst or other flowable-substance-containing structure located within a paranasal sinus, said device comprising: an elongate shaft; a penetrator that is advanceable from and retractable into the shaft, said penetrator being useable to form an opening in the mucocyst or other flowable-substance-containing structure; and a compressor useable to compress the mucocyst or other flowable-substance-containing structure such that its contents will be forced out of the opening formed by the penetrator.
2. A device according to claim 1 wherein the penetrator is a needle.
3. A device according to claim 1 wherein the compressor comprises a balloon.
4. A method for treating a mucocyst or other or other flowable-substance-containing structure located within a paranasal sinus, said method comprising the steps of:
- A) providing a penetrator that is useable to form an opening in the mucocyst or other flowable-substance-containing structure;
- B) providing a compressor useable to compress the mucocyst or other flowable-substance-containing structure after an opening has been formed therein by the penetrator such that its contents will be forced out of the opening formed by the penetrator;
- C) advancing the penetrator into the paranasal sinus and using the penetrator to form an opening in the mucocyst or other flowable-substance-containing structure; and
- D) positioning the compressor in the paranasal sinus and using the compressor to compress the mucocyst or other flowable-substance-containing structure such that its contents will be forced out of the opening formed by the penetrator.
Type: Application
Filed: Oct 29, 2007
Publication Date: Apr 24, 2008
Patent Grant number: 7727226
Applicant: Acclarent, Inc. (Menlo Park, CA)
Inventors: John Chang (Mountain View, CA), Joshua Makower (Los Altos, CA), Julia Vrany (Sunnyvale, CA), Theodore Lamson (Pleasanton, CA), Amrish Walke (Santa Clara, CA)
Application Number: 11/926,524
International Classification: A61M 29/02 (20060101);


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Directly observed therapy (DOT) refers to the taking of medications in the presence of a medical provider, either in the provider's office or at the patient's home, so the provider can actually watch the pills being swallowed. To date, the use of DOT has been used mainly to help control the tuberculosis (TB) epidemic. DOT programs are an effort to increase medication compliance to achieve better treatment successes. High treatment completion rates, substantial increases in cure rates, and improved survival associated with TB DOT have been documented in the United States. DOT programs have also made great strides decreasing the TB burden in many developing countries. A growing number of projects in Asia, South America, and Africa demonstrate that population-based DOT is feasible in countries without an otherwise well developed public health infrastructure.
The strategy of the World Health Organization (WHO) for TB includes DOT as one of its components. Given the difficulty in predicting which patients will adhere to the anti-TB regimen prescribed, the WHO supports "universal" DOT for TB. DOT programs frequently consist of more than just observed therapy. They include various additional interventions to increase compliance through incentives, aggressive outreach methods to re-engage persons, medication reminders, motivated and supportive staff, improved access to health services, and additional external funds. It is likely that it is the range of interventions associated with DOT that makes it so successful; DOT may simply be a marker of a more intensive effort towards TB control. Participants identified the access to good medical care and staff as the most important aspects of the DOT strategy. DOT alone without other supportive interventions is unlikely to be effective. This is corroborated by a study that found no difference in the treatment success rates between self-observed therapy (SOT) and DOT when other supportive measures were not used. However, when combined with these other interventions to improve adherence, DOT has increased the success rate of TB treatment when other non-DOT strategies have failed. Acceptance of DOT by both pill takers and providers has generally been high, particularly when DOT is addressing a medical concern, such as TB control. Lastly, in resource-poor settings, DOT overall has been shown to be more cost efficient than SOT for TB.
Since DOT for TB has been largely successful in many settings worldwide, and since similarities exist between HIV and TB, it is reasonable to consider using the DOT strategy for highly active antiretroviral therapy (HAART). TB and HIV are similar in the development of multi-drug resistance due to exposure to inadequate or intermittent treatment. They are both global health threats and have complex treatment regimens with multiple toxicities. Several pilot programs have had some preliminary success using DOT and modified DOT to increase adherence to HAART, but a large randomized controlled trial has yet to be done. (For people who take medications multiple times a day, only the pills that are taken in the morning are observed in "modified DOT.") Plus, most studies to date have concentrated on special populations of people with HIV, such as prisoners, people in methadone maintenance programs, children, people with TB, and people with a past record of poor adherence.
DOT has been used to increase adherence with HIV medications in the prison setting. In Italy, 37 prisoners who received DOT were compared to 47 prisoners who were given their daily medications and not observed. After a mean of 8.7 months, an undetectable viral load was achieved in 62 percent of prisoners receiving DOT versus 34 percent of prisoners doing SOT. Within the DOT group, there were also significant increases in the CD4 count. In another study, DOT was administered to 42 HIV-positive women in a correctional center in Buenos Aires, Argentina. Eighty-four percent of women had a rapid decrease in their viral load. Two studies compared DOT in prisoners to SOT in an outpatient population. The first was an open pilot study that found that viral suppression was significantly greater with DOT, but that there was no significant difference in the increase in the CD4+ cell count between the two study groups. The second was a non-controlled, retrospective analysis of 100 treatment-naive subjects that also showed that DOT had a greater virologic success than SOT.
Rather than enrolling prisoners, S.L. Hader enrolled 148 people admitted to two residential AIDS treatment facilities in New York. In an antiretroviral-experienced population, although DOT achieved an impressive 99 percent adherence rate, only two-thirds of the residents achieved an undetectable viral load and 41 percent had a treatment failure at least once, regardless of their regimen.
Modified DOT has been easily incorporated into methadone maintenance and TB treatment programs, since the patients are already observed swallowing their morning medications during the week. B. Conway found that after a median follow-up of 11 months, 9 of 13 people on a once-a-day HAART regimen and 8 of 12 on a twice-a-day regimen had a viral load below 400 copies/mL. During an 8-week intervention at a methadone maintenance program in San Francisco, participants receiving modified DOT showed slightly better adherence rates on all outcome measures when compared to usual care participants, but there were no significant group differences in any measures at the 1-month follow-up. In HIV-positive people with TB, it was found that supervision of the morning dose of HAART led to better adherence with evening medications and more awareness of potential side effects of the medication regimen.
Research using DOT has also focused on populations with documented or anticipated non-adherence. M.S. Stenzel was referred 49 high-risk people, of whom 37 agreed to participate. Of the 12 who refused to participate, 5 reported the ability to take their own medications without assistance, 4 felt the regular home visits were intrusive, 2 were homeless and unable to arrange regular contact, and 1 was unwilling to initiate HAART. Modified DOT for HAART was given at the patient's home every morning during the week and prepackaged medication was given for the afternoon and weekend doses. Six participants (16 percent) missed visits for 2 weeks and were disenrolled, 3 (8 percent) discontinued HAART, 5 (14 percent) opted to take medications without modified DOT because they didn't like home visits, and 17 (46 percent) completed 12 months of modified DOT. There was a significant virologic response on DOT, but there was no control group as a comparison. At enrollment, 4 of 37 people (11 percent) had a viral load below 400 copies/mL; at 3 months, 14 of 30 (47 percent) people had achieved that level; and at 12 months, 10 out of 18 (56 percent) had. There was also an immunologic advantage to DOT. The mean CD4+ cell count increased to 245 cells ug/L at 3 months and 339 cells ug/L at 12 months.
DOT for HAART may be more cost-effective and ultimately more successful in resource-poor settings where the cost of antiretrovirals is relatively high, especially when compared to the cost of personnel. Since 1998 in Haiti, one of the poorest countries in the world, Dr. Paul Farmer has been conducting a preliminary demonstration project of DOT for HAART. The program is modeled after the existing TB-control program in the country and involves a community health worker observing the ingestion of pills and providing support and assistance with social services. An initial cohort of 60 people has been enrolled and although outcomes have not been systematically analyzed, 18 of 20 had undetectable viral load after 4 to 30 months of follow-up.
Unlike TB, however, HIV requires long-term, potentially life-long, therapy. The goal of DOT programs for HAART is to improve education and foster medication self-administration over a limited time period, leading to long-term improvement in medication compliance. However, the data on long-term results associated with DOT is very limited. In the study by M. Fischl, HIV-positive individuals who received DOT had both greater short- and long-term virologic responses compared with those that received SOT. After 80 weeks, the number of patients with an HIV viral load below 400 copies/mL was 95 percent for those receiving DOT and 75 percent for those receiving SOT. M.S. Stenzel found that 47 percent of people understood how to take their medications at baseline and 80 percent understood at 3 months. At 12 months, most people felt prepared to take their HAART with minimal assistance. J.L. Sorenson, on the other hand, found that although modified DOT distributed at a methadone maintenance program enhanced medication adherence, it did not produce effects enduring beyond the time of the intervention.
It is still too early to judge long-term adherence following completion of DOT. The optimal duration of DOT for HAART, the most appropriate candidates to target and its cost effectiveness are all questions that still need to be answered. The AIDS Clinical Trial Group has begun a study to compare DOT to standard, self-administered medications. This study is discussed in more detail in this issue of the STEP Perspective.


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text:
My Oscar picks.
Best Picture
In addition to expanding the field from five films to ten, The Academy of Motion Picture Arts and Sciences has instituted an Instant Runoff Voting system. Leaving aside the merits or flaws of this system, it's a provocative decision that could result in a big night for The Hurt Locker. Like its director James Cameron, Avatar is a very polarizing film, which means when offered the option to rank films by preference – which is what you do with IRV – instead of voting for a single film, Avatar might not be everybody's all American, thus allowing The Hurt Locker, which is likely to be everyone's favorite first runner up, to snag the top prize.
Best Director
Having swept many of the directing awards, including the BAFTA, it seems likely she'll snag this one too. The film is well received, she hasn't pissed off too many academy voters and she makes movies that straight dudes like. I am a huge fan of her work, with Strange Days and the two parter "Fallen Heroes" from season six of Homicide: Life on the Street being my favorites. That said, I am not under any illusion her win will usher in powder pink Perestroika for women filmmakers or signal the collapse of the male dominated movie industry. Bigelow makes action movies, favors hand held cameras and jump cuts. So I do feel conflicted over her nomination because it reinforces the whole idea of there being women's stories and then real stories and only those real stories – ones about men, war or power – are worth telling. But, hey, you gotta dance with the one who brung ya!
Best Actor
This is The Dude's year! After seeing the reaction Bridges received during his Golden Globe acceptance speech, I became pretty convinced he was going to be nominated and win the Best Actor Oscar. The only person who could jostle The Dude's White Russian is Colin Firth, but unless some new shit comes to light, I really can't conceive of that happening. This is a beloved actor from an acting family who has given stellar performances throughout his lengthy career. Am I wrong?
Best Actress
For some reason I thought Bullock was on that same island where they're keeping Meg Ryan and where Rachel McAdams is going when she turns forty. Apparently not! The movie – The Blind Side – is riddled with all kinds of -ism fail, but it's the kind of showy role the academy loves to see its leading ladies do. With all the subtlety of a trumpet fart in church, Bullock has taken a page from the Julia Roberts (Erin Brockovich), Shirley MacLaine (Terms of Endearment) and Cher (Moonstruck) How-to-win-an-Oscar play book.
Best Supporting Actor
Like Tommy Lee Jones in The Fugitive and Lou Gossett Jr. in An Officer and a Gentlemen before him, Christoph Waltz leveraged his charismatic megalomania for a shot at Oscar gold. He'll get it too. The academy loves them some over the top supporting performances and oddly enough, it is this award and not the Lead Actor award that generally catapults its winner onto the A-list. Before The Fugitive, me and like Mama Lee Jones were like the only people interested in TLJ's career.
Best Supporting Actress
While I hesitate to curse the incomparable Mo'Nique with this dubious award, I'm pretty certain she'll get it. Like the "Best New Artist" Grammy, this award is a career killer. Mary Steen-who? If it doesn't render you unemployed, it at least renders you irrelevant as an actress. There are a few notable exceptions, but for the most part, it's probably better NOT to win this. Fat, Black women have done well in this category, both as noms (Whoopi and Queen L) and J-Hud won it. Of course, what are they doing now acting wise? It certainly does not do for women, what the equivalent award does for men. Still, the academy loves seeing minorities give poverty pr0n or shuck and jive performances, particularly if it seems (to the academy anyway) to be drawn on some personal experience.
Please note: these are the folks I think will win and in many cases aren't necessarily the folks I think should win


text:
Professor says his departure is unrelated to recusals over potential conflicts
Robert Fellmeth, the University of San Diego law professor whose students formed the Utility Consumers' Action Network 30 years ago, has resigned from the nonprofit's board after recusing himself from several matters because of potential conflicts of interest.
The resignation, six months after Fellmeth joined the group's leadership as it coped with a federal investigation into UCAN business practices, was formalized at a board meeting last week.
Fellmeth said his departure was unrelated to the potential conflicts that caused him to recuse himself.
"I repeated at two prior meetings that I intended to leave the board as soon as it had enough members," Fellmeth wrote in an email Monday. "I am part of the governance of three major national organizations representing the interests of children, and have rather a lot to do representing them."
Donald Kelly, a former Fellmeth student who is now the UCAN executive director, said Fellmeth's service is much appreciated and the law professor remains available for special consultation.
View the Video Watchdog Minute : UCAN conflicts
"He has too many other things that he is focused on right now," Kelly said. "He did mention how he was constantly recusing himself from voting on certain issues because people might perceive there may be a conflict."
The advocacy group fights for consumers and collects significant revenue when it wins in court or with state regulators. One of UCAN's main adversaries has been
Fellmeth, one of the original Nader's Raiders who became famous for working for consumer rights with activist Ralph Nader, now serves as the Price Professor of Public Interest Law at USD.
In addition to teaching law classes, Fellmeth works as executive director of two organizations he founded, the Center for Public Interest Law and the Children's Advocacy Institute.
He is also an adviser to the Energy Policy Initiatives Center, a USD think tank he helped create that accepted at least $82,000 from SDG&E and parent company Sempra in recent years.
Also, according to court records, UCAN itself gave EPIC $345,000 from a $2 million settlement the consumer group was awarded in a class-action suit against the Rent-a-Center furniture chain.
Fellmeth also has ties to Michael Shames, a former student and the former executive director of UCAN who is suing the group for libel. Shames says he has been harmed "by the release of personal and unauthorized information." He is represented in that case by attorney Hallen Rosner, a former student and law partner of Fellmeth's who wrote a column for the UCAN website.
As recently as November, Fellmeth served as plaintiff's attorney in a case called Shames v. Hertz, which involved a class of car rental customers including Shames.
The class-action case against rental car companies brought legal fees of more than $670,000 to the USD Center for Public Interest Law, created and run by Fellmeth.
Fellmeth said his service to UCAN was unrelated to other interests, and said he never voted on issues related to Shames.
"I have voluntarily recused myself from any vote of the UCAN board involving anything to do with Michael Shames," he wrote.
Former UCAN Executive Director Kim Malcolm, who succeeded Shames last spring and quit after a few months, said Fellmeth introduced himself to her and suggested he would be a good addition to the UCAN board.
"Mr. Fellmeth approached me about joining UCAN's board," she said. "Shortly after I joined UCAN as executive director, he sent me an email describing his longtime commitment to UCAN and inviting me to lunch."
Fellmeth said he offered to help but never sought a board appointment.
"I told (Malcolm) and other board members repeatedly and publicly that I would be happy to help with the restart in any way that might be helpful," Fellmeth said, adding, "I have never sought to be a part of UCAN governance."
In a related development, UCAN staff attorney David Peffer resigned last week. Peffer was one of two employees who alerted the board in 2011 that he believed the agency had granted unapproved bonuses and kept secret bank accounts, among other irregularities.
"They are committed to making these problems go away rather than uncovering the truth," Peffer said Monday. "I can't be a part of it, and I can't be seen as being a part of it."
Kelly said the nonprofit is addressing problems and moving forward, and in fact is preparing amended federal tax filings to disclose bonuses as required and make other corrections of past documents.
At the board meeting last week, former San Diego Councilman Jess Haro was voted onto the board. Haro, who was removed from office in 1978 after being jailed for misdemeanor customs violations, was honored as a "living legend" by Mayor
"I'm very glad he's decided to become a member of our board," Kelly said. "I am always on the lookout for good board members."
- Utility action group disbanding amid probe
- Intrigue surrounds utility group spat
- Fissures formed a year ago for UCAN
- Boss bonuses at UCAN totaled $249,000
- UCAN settlement would allow group to go on
- New leader at action group after turmoil
- Consumers group endangered again
- UCAN boss prepared an out, had side businesses
- More activity in federal UCAN probe
- UCAN demands $474K from ex-boss
- Utility group transaction under scrutiny
- Shames sues UCAN for libel
- UCAN to fix past tax filing


text:
The decision will satisfy both Leninists and Latinists.
Tuesday, 13 November 2012
T 1149/11 – Trust Is Good, But Control Is Better
The decision will satisfy both Leninists and Latinists.
5 comments:
Mr. Z could also have looked at the date on the decision, and rehearse the good ol' 10 days + 2 months calendar fumbling EQE routine. I doubt that the notice of appeal was drafted on the very morning of the (falsely) calculated dated.
The appellant filed a video recording as a part of his arguments in defense of patentability. It would have been interesting to see how the board would have handled this, had the appeal been filed in due time.
- 13 November 2012 at 21:50
Thanks Oliver.
I am indeed satisfied both as a latinist and as a leninist; but not so much as a patent attorney: with this new onus of three cure, it's definitely not a sinecure.
- 13 November 2012 at 23:13
Vu que le brevet est perdu, autant partir en cure avec l'assistante (cura in amando) ...
- 13 November 2012 at 23:35
Bien vu, la cura in amando!
Et après on chante no cure for love.
- 14 November 2012 at 00:39
I'll take the US standard for revival any day over all due care as it has been interpreted.
- 16 November 2012 at 14:30


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Bank of England Names Carney as New Governor
Bank of Canada's Mark Carney was named as the Bank of England's new governor, the British government announced. Charles Forelle reports on Markets Hub. Photo: Reuters.
This transcript has been automatically generated and may not be 100% accurate.
... I ... it ... is like for children ... the non executive members of the call of the Bank of England said they will consider in addition a relocation and accommodation package ... which you'd expect with such matters ... Mahtani is not a purchases and ... he is a subject of the Queen ... is why ... is that ... his wife ... is British ... useful to ... you ... no wonder when the new loan not coming out in the living New Bank of England Governor Mark Carney taking over from Mervyn King ... Charles Forelle is here to give as the D tells on this on this one just broke a little while ago ... I prob is this what a surprise Mark Carney did ... this this was a she and the AI can be betting betting parlors around London the bookies are scrambling today I'm sure ... I'm the odds on favourite for the job was a binky insider ... and Mr Kearney from the Bank of Canada obviously he's not ... he's been a unit innocent Rebecca for for a long time and has received a lot of credit for ... absent shepherding the Canadian banking system to system through a lot of the financial ... stress nobody else ... on the head and suffered from ... that again this is is it totally unexpected thick as a as we speak right now ... I enjoyed Osborne the Chancellor's in parliament time talking over Tibet the ... announcement which came at a couple months ago ... will we first cut into the though of ... course is to move his family from Canada one game that ... you want one would hope it's a big job and that's a big ballad it's a big ocean between the two places write ... all ... I mean that in the wind out ... really an outsider me that the nation ... why why such an outsider ... I mean it did mean changes in an oz born in said earlier in the process given the way that there are going to make this ... I need be said of all encompassing surge that put a job and in the economists to try to solicit candidates and ensure that ... that was how Mr. Kony applied but ... I'm getting the bank has for a large part of its recent history ... it ended though not always to Cheesecake insiders tell the people from the ranks ... I'm and David baby and said you know that China's seek experience from elsewhere and ... and they certainly have got ... Mervyn King for a second will step down in June ... the thirty year term so ... Mervyn King him ... rather tumultuous years he's a ... what he's an elitist is going to be ... no easy Senate had an extraordinary ... and then attended the Bank of the ... UN be crazy he suggests is one of the most tumultuous and in modern times ... I'm obviously there's a lot of ... the reckoning in questioning of doubt that the Bank of England's role in them in the financial crisis aam ... did as incentive as an aide ... I didn't buy the leader on a unit of Bank of England's move to relatively aggressively with the QE programme ... on to try to address the after effects the broad reach way down into thousandnine and held him down ... on the move ... quite aggressively for more aggressively than their peers in Frankfurt ... I am trying to look twice monetary stimulus to to get the UK out of its ... funk so it's a certain extent the shore ... what do you think you'll be looking for from Courtney from the Bank of England ... isn't important central bank of these and got the pound ... dog in the wrong ... it seems like the Bank of England is kind of play second fiddle to the ECB the Fed what are you looking for from the spring ... well you know that the Bank of England obviously has its own issues to deal with the win ... you know with with the U K economy UK counties in kind of a strange places doing probably in a marginally better than its ... I've been its friends across the channel in Europe and that's not saying a lot ... there is ... I'm innocent remain substantial questions about the future of growth in the U K ... inflation has come way down in a bit sinister Vivendi ... had a ... and in difficult monetary policy moment in the counties not growing as much as they would like ... aam but they've used a lot of the conventional in some unconventional tools the question is ... you know what now the rates are already at rock bottom ... levels they started the study Kiwi quite early ... they've embarked on another ... couple bothered the ... difference nonstandard measures the question is if it doesn't work to get growth going again What's Next Tuscany is intellectually challenging ... on ten year for Carney in the next couple of years ... for girls took the first ... row of palm side of Paul Tucker ... deputy governor use one of the names being thrown out there in ... his new nobody's favorite to get in the evening got wrapped up a little live or scandal what happens with him that ... well you know it's easy it's not clear at the moment at the gym again is this just came and I'm a moment ago hasn't been any reaction from from anybody else ... but he did that I a you know come up in the live or scandal there's a question over ... the complicated interchange between him and Bob Diamond's of Barclays about whether ... I did Tucker was suggesting to Mr. Diamond's of it the bank underestimated Spain's borrowing costs ... on all of that that very complicated it certainly left out ... to people with a bad taste them as a bad Tucker but at the same time he had been certain that he ... did to some extent the youth ... to Vote for continuity in the boat for ... aam caution in calm ... I am finding a maintaining the continuity the Bank of England ... but obviously Osbourne was in a different direction who are ... on tolls does Korea to apply for British citizenship for those that work with Canada being the Commonwealth in the middle class room and that that serve as a very good question but I suspect that having a Canadian passport will will get in and ... as a subject of the Queen there are eight rolls prolong the without breaking news think very much sir ...


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The government has been saying that industrial upgrades and innovation are key to reviving the dire state of the nation's manufacturing sector and the economy as a whole, as manufacturers face increasing competition from China and South Korea.
However, more than empty slogans will be needed to make a successful industrial transformation. To compete with foreign firms, Taiwan first needs to increase its own capabilities, rather than relying on bilateral trade agreements.
The easiest, most effective way to help local industry to offer higher-value products and services is for the government to listen to what corporate executives advise. However, apparently government officials do not take local corporate executives' words seriously.
"Not a single government official has approached me to discuss how to build an electric vehicle supply chain in Taiwan," Simplo Technology Co chairman and chief executive officer Raymond Sung (宋福祥) said last week.
Three years ago, Sung suggested that the government concentrate state resources on developing a supply chain for electric vehicle production, given that the electric car industry looks set to be the next big industry and that it could provide a chance for the manufacturing sector to reclaim its glory.
This was not the first time Sung has complained of the government's bureaucratic inertia.
Sung said he feared that the nation could quickly lose its edge if the government remains inactive.
To facilitate development in a small market like Taiwan, Sung advised the government to create a single platform for automakers, component manufacturers, research houses and colleges to jointly produce energy-efficient cars.
Simplo, which supplies battery packs to Apple Inc, has started supplying batteries to electric bike and bus manufacturers in China, Europe and Japan. The company hopes the business will ignite growth.
Sung has said that the nation is good at manufacturing and all it needs is to form a task force to bring together national and industrial resources and to avoid wasted investment through multiple parties developing the same technologies.
Many local colleges and universities poured resources into developing electric cars, but the vehicles they showcased were all very similar.
Hon Hai Precision Industry Co, which assembles iPhones and iPads for Apple Inc, has also showed strong interest in investing in the electric car business.
Taiwan has already built an electric vehicle supply chain, but it is not strong enough to fend off global competition, as most of the producers are small and medium-sized businesses.
Taiwanese companies supply key components to US electric car maker Tesla Motors Inc. The firms face losing orders from Tesla once Tesla moves a local factory back to the US and builds a new one in China. Chroma ATE Inc, which provides precision test and measuring instrumentation, automated test systems and automation solutions and was one of Tesla's major local partners, lost orders for its services for Tesla's new car, the Model S.
It is clear that the risk of losing competitiveness is imminent. Totally ignoring the time constraint, the Cabinet said it has tapped 20 economic experts and industry representatives to attend a series of national economic conferences next month at the earliest. The meetings aim to map out strategies for dealing with cross-strait trade ties with China and the growing trend of inking bilateral trade pacts.


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Jon Gosselin and his on/off/pseudo girlfriend Hailey Glassman, continue their attention whoring ways in their latest interview with Entertainment Tonight.
We reported yesterday that Jon stormed off the set of the interview during an argument between he and Hailey, well today comes news that the two also clashed over thanksgiving dinner during the interview. Hailey also reveals the Jon & Kate Plus 8 dad will be spending Thanksgiving with she and her family, and not with his 8 kids.
"My family and I would never let him eat Thanksgiving dinner alone in an apartment," says Hailey, even though it seems as though the two are breaking up on camera. "He's coming to our house for Thanksgiving. I don't care." Jon adds, "I still planned on going to her house on Thanksgiving; that was on my schedule," raising the eyebrows of Hailey.
Hailey isn't thrilled with his answer. "On your schedule? What do you mean, 'On my schedule?'" she asks. "Let's see, Kate has the kids, and she's having a nice huge meal with Steve and his family. Uh, let's see, should I go to Hailey's or should I sit in my apartment all alone?"
"Sorry, I used the wrong term," says Jon. "I plan on going — I made a promise to her family I would go to her house."
"Made a promise? You're not doing my family any favors!" replies Hailey. "We know what the right thing to do is. We know what we both need," she continues. "He needs to do his thing and I need to do my thing. We both know this."
Pretty certain I just lost a few brain cells reading the above conversation between these two. It's safe to say these two are being paid a nice amount to air out their dirty laundry.


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Black Friday: Germiest Places at the Mall
Hand sanitizers can be best defense against germs while shopping.
Nov. 23, 2012 -- While the health hazards of increasingly competitive holiday shopping now include stampedes and pepper-spraying, bargain hunters must also guard against more mundane hazards: other people's cold and flu viruses.
Shopping centers that teem with people also teem with germs. But alcohol-based hand sanitizers and good hand washing can defeat most common microbes.
"My wife won't go anywhere without hand sanitizer in her purse. I put some into my jacket pocket. You just use those frequently when you're out and about," said Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn.
He said he doesn't obsess about germs, he's just "attentive to them."
Before hitting the mall, it pays to plan how you'll deal with germy hot spots:
The Air
Hand sanitizers and hand washing cannot protect you from what's floating in the air, Schaffner said. "The great hazard is being that close to so many people and being in everyone's breathing space."
"It's not too late, by any means, to get your influenza vaccine," he said. "If you're out and about, all those pharmacies are open and they would welcome your coming in and giving you your influenza vaccine.
"We live in a world that's not sterile, but what we'd like to do is be hygienic, so let's try to avoid the obvious coughers and sneezers in the crowd. Go to another counter until they've passed," Schaffner added. "If you are coughing and sneezing, put off your shopping a bit, which would be the kindest thing from a public health point of view."
If you must sneeze or cough, do so in the crook of your elbow, a technique publicized during the 2009 swine flu pandemic and mastered by lots of schoolchildren, said Dr. Jeffrey Boscamp, a pediatric infectious diseases specialist at Hackensack University Medical Center in New Jersey. You may not be doing your fellow men and women any favors if you cough into your hand because "the next thing you know, you're shaking hands."
Public Restrooms
Public restrooms can be a germ-laden nightmare, but they're also where you can wash away unwelcome microbes. Although soap dispensers and faucet handles "can be a little nasty," after being touched by people who have just done their business in the stalls, you can wash your hands thoroughly, then grab a paper towel and quickly turn off the faucet with the towel, Schaffner said.
Boscamp pointed out a bigger bathroom risk from germ-laden door handles. Even if you wash your hands, you're "at the mercy of people who don't wash theirs," he said. "Sometimes I've been crazy enough to keep my paper towel in my hand."
Food Court Tables
Think about how many people have touched the tables, napkin dispensers and chair backs at a mall food court or restaurant, and you have another reason to wash your own hands or use a hand sanitizer. Just as kitchen sponges offer a warm, moist environment that lets food bacteria to multiply, the rags used to wipe down dirty tabletops are "a decent medium for bacteria to dwell in," Boscamp said.
Escalator Handrails
Most people grip the handrails when riding escalators inside malls and stores, leaving behind normal skin bacteria plus other germs picked up from rubbing their noses or mouths. Schaffner said he's not too worried about this particular hazard.
"If you use your hand sanitizer periodically during your afternoon safari at the mall, I think you'll be pretty well-protected," he said.
Boscamp thinks of escalator handrails the way he thinks about the metal bars subway riders hang onto.
"It's probably a good idea after contact with things like that to be thinking about Purell," he said.
Toy Stores
All those sniffling tots inside toy stores, along with the healthy ones who just like to put everything in their mouths, can leave invisible coatings of germs behind -- not to mention what they spew into the air when they sneeze or cough.
"The number of hygienic children in the United States I can count on the fingers of my hands," Schaffner said. "I have to admit, children are the great disseminators of respiratory viruses. They do so because, first of all, when a virus infects a child, the child actually breathes out a lot of virus, more so than adults. They do so for a longer period of time."
Although most toys remain in the boxes and packages in stores, any that are unwrapped and available for children to touch, lick or rub against their runny noses could become infection-spreaders, Boscamp said. That's why his medical center and others request that any holiday donations of toys for sick hospital patients be in original, sealed packaging.
"We don't take chances," he said.
Electronics Stores
The slick surfaces of smart phones and tablet computers can harbor a variety of germs, including staph, capable of living several hours. However, just because environmental hygienists can swab such surfaces and find a variety of bacteria doesn't mean they necessarily will make you sick, said Schaffner.
"Try out your candidate iPhone, look at it, play with it, and then do your hand sanitizer thing," he said.
Some Surfaces Not to Worry About
Although women frequently hear they should avoid shared testers at makeup counters, "infections associated with shared makeup are virtually nonexistent," Schaffner said. "They are not a recognized public health problem."
Worries about picking up germs from ATMs at the mall might be exaggerated, too, even if you've never see a bank employee wiping down ATM keys.
"If for some reason, you're a little queasy [about uncleaned keys], go to the ATM, get your cash and use your hand sanitizer," Schaffner said.
Schaffner made his comments just before heading off to the gym, where he relies on hand washing and hand sanitizer.
"I don't rub down machines," he said. "By protecting ourselves with our hand sanitizers, I don't think we have to go around sani-wiping the world."
A version of this story previously appeared on ABCNews.com.


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life through my lens
I'm Victoria Stuart, a poet who philosophizes and sings about family matters and entanglements.
Capturing the tiniest details of God's artistry
Less is not enough.
Everyone Has Something To Teach Us
age is just a (biggish) number
Taking the camera for a walk!!!
Capturing the beauty of God's creation through the lens of a camera
Expressing Thought Through Photography
Reflections on Life through poetry, essays and photos
a painter´s attempt to conquer the great white canvas
Wits End Photography
Creative Exploration in Words and Pictures
Dil se Dil tak...
To participate in the Ragtag Daily Prompt, create a Pingback to your post, or copy and paste the link to your post into the comments. And while you're there, why not check out some of the other posts too!
Flash Fiction, Poetry, and Short Stories
Mostly photographs with some words by this arty scientist...
Rural doctor, mom, writes poems, dance, sing.
Lifestyle, Travel, and Traditional Art


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Courtesy of the National Shooting Sports Foundation (NSSF), Gunsite Instructor Cory Trapp goes through AR-15 disassembly, cleaning, maintenance and inspection.
This is one of the better videos I've seen on this subject, especially how Trapp dispells several AR-15 myths related to lubrication and reliability.
Click Here for a Free Download on AR-15 Optics
Click Here for a FREE AR-15 Gun Cleaning How-To Download
He covers:
- AR-15 disassembly and reassembly
- Why the .223 and 5.56 are not interchangeable
- AR-15 feedramps: Standard M16 vs. M4 styles
- AR-15 Bolt disassembly and maintenance tips
- Trigger group cleaning (what not to do)
- How to replace the extractor spring
- Spare parts you need on hand for your AR-15
- How to properly reassemble the bolt assembly
- Why you should not lubricate your lower or the buffer
- What to look for when doing an inspection
- The AR function check you should do each time you reassemble your AR
If you like this video, I also recommend Gunsmithing The AR-15
You'll Love This If:
- You own an AR-15 and want to learn how to fix or upgrade it yourself
- You're a professional gunsmith or are studying to become one
- You want to maintain your AR-15 for years of rugged, dependable use


text:
Landmark articles on NMR: the authors speak
Blog Post
- Published: May 11, 2012
- Author: Steve Down
- Channels: X-ray Spectrometry / Chemometrics & Informatics / Infrared Spectroscopy / Atomic / NMR Knowledge Base / Raman / Proteomics / UV/Vis Spectroscopy / Base Peak / MRI Spectroscopy
The Journal of Magnetic Resonance has published a series of papers over the years which have been afforded the status of "Landmark Articles." In recognition of these, the journal publisher, Elsevier Publishing, has produced a series of videos in which the authors of some of these papers talk about their work and the basis behind it.
The set of 17 videos can be seen on youtube, ranging from 2-12 minutes in length. The original papers were published from 1975-2005 and include one by Richard Ernst, winner of the 1991 Nobel Prize for Chemistry.
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