| Perorally removeable anti-reflux valve implantation -> Monitor Keywords |
|
|
 
Perorally removeable anti-reflux valve implantationRelated Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Implantable Prosthesis, Hollow Or Tubular Part Or Organ (e.g., Bladder, Urethra, Bronchi, Bile Duct, Etc.), Including A ValvePerorally removeable anti-reflux valve implantation description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060041319, Perorally removeable anti-reflux valve implantation. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional application Ser. No. 60/302,870, filed Jul. 3, 2001, and entitled Perorally Insertable/Removable Anti-Reflux Valve, which is hereby incorporated by reference in its entirety. BACKGROUND OF INVENTION [0002] This invention relates to a device and non-invasive surgical method for treating gastroesophageal reflux disease. More specifically, it relates to an anti-reflux valve prosthesis and associated instrumentation for its peroral placement and in situ fixing at the gastroesophageal junction, to prevent the reflux of gastric contents into the esophagus. The invention further relates to the instrumentation and methodology for peroral removal of such a prosthesis. [0003] Gastroesophageal reflux disease (GERD) is the commonest cause of dyspepsia, affecting some 30% of the United States adult population intermittently and some 10% on a continuous and troublesome basis. Gastroesophageal reflux disease produces heartburn, abdominal pain and regurgitation of acid-containing gastric contents into the esophagus and pharynx. It may also lead to alteration of the lining of the esophagus (Barrett''s Esophagus), which may in turn lead to esophageal cancer. Current methods of treating GERD include powerful antacid medication therapies and surgical interventions. [0004] Medication therapy with powerful antacids is directed at treating the symptoms of GERD, and is necessarily not curative. Furthermore, medication-based therapies are not always fully effective, as reflux is not prevented and the esophagus may continue to be exposed to gastric content. [0005] Surgical intervention typically involves either open surgery (performed through the abdomen or the chest) or laparoscopic surgery (performed through one or more incision access ports inserted through the abdominal wall), and the re-sectioning of tissue or the implanting of a prosthetic device. Although surgical interventions can be curative, these treatments are seriously invasive and have the attendant risk of such procedures. Despite the risk, the field has been motivated to provide solutions to the GERD problem, which has resulted in the development of a number of surgically implantable anti-reflux valve prosthetic devices. Prior anti-reflux valve prostheses are essentially one-way valves implanted at the gastroesophageal junction using open or laparoscopic surgery. The implanted prosthesis allows normal swallowing to take place in an orthograde manner while preventing the reflux of gastric contents from the stomach into the esophagus. [0006] Examples of surgically implanted esophageal anti-reflux valve prostheses include the devices of: Godin (U.S. Pat. No. 5,314,473) which discloses a one-way, antivalve comprising a flattened tubular part associated with an annular fixing element; and Reich (U.S. Pat. No. 4,846,836) which discloses a bi-directional valve and housing for similar purposes. These devices were developed to be inserted into the gastro-esophageal junction via open or laparoscopic surgery and fixed there. The purpose was to permit the unidirectional passage of ingested materials into the stomach while preventing the reflux of gastric content of the stomach into the esophagus. Typically, these devices require suturing or other means to fix them to the tissue of the esophagus. [0007] Generally, all of these prior devices and methods require surgical invasion of a body cavity and breach of the body membrane in some fashion (e.g., open surgery or laparoscopy) in order to accomplish their utility. Invasive surgical interventions are too frequently complicated by problems such as stricture formation, "gas bloat," or recurrent symptoms of reflux disease. Additionally, the results obtained by gross surgical treatment can be technique-dependent and vary significantly from surgeon to surgeon. [0008] More recently, perorally implantable valve prostheses were disclosed for fixation in the esophageal lumen near the gatroesophageal junction in patent applications by one of the present co-inventors, Dr. Thomas V. Taylor, U.S. Ser. No. 08/987,693, filed Dec. 9, 1997, U.S. Pat. No. 6,254,642; U.S. Ser. No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. ______; and U.S. Ser. No. 09/681,364, filed Mar. 26, 2001, U.S. Pat. No. ______; each of which is hereby incorporated herein by reference in its entirety. SUMMARY OF INVENTION [0009] The present invention relates to an anti-reflux valve prosthesis system for treating gastroesophageal reflux disease (GERD) in a patient, which does not require open or laparoscopic surgery to implant. The present invention provides for perorally inserting a removable sutureless anti-reflux valve prosthesis down the lumen of the esophagus, to the gastroesophageal junction, where it is fixed in place. The advantage of this system is that peroral insertion of such a valve eliminates the need for either open formal laparotomy, thoracotomy or a laparoscopic approach using multiple access ports. In the event it is later desired to remove or replace the prosthesis, the valve can be removed using a peroral extraction tool, again generally without the need for laparotomy, thoracotomy, laparoscopy, or any other surgically invasive technique. [0010] In one aspect, the present invention provides an anti-reflux valve prosthesis. The prosthesis has an annular fixation element for fixing the prosthesis in an esophagus, and a one-way valve depending from the annular fixation element for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. The valve includes a semipermeable membrane that is essentially liquid impermeable, but gas permeable to allow retrograde permeation of gas through the valve. The prosthesis can be configured to be perorally installed or perorally removable. The one-way valve of the prosthesis can be a sleeve valve. The prosthesis can be made of a biologically inert material, including but not limited to, a fluorinated polymer. The prosthesis is configured to be implanted in the esophagus of a patient with gastroesophageal reflux disease (GERD), preferably when that patient''s esophagus is cancer free. [0011] In another aspect, the present invention provides another embodiment of an anti-reflux valve prosthesis that has an annular fixation element for fixing the prosthesis in the esophagus and a sleeve valve depending from the annular fixation element for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. The sleeve valve has a plurality of magnets secured at a distal end thereof to facilitate closure of the valve. Additionally, the prosthesis may contain a gas permeable membrane to allow retrograde permeation of gas therethrough, where the membrane is preferably liquid impermeable. [0012] In still another aspect, the present invention provides an anti-reflux valve prosthesis for peroral implantation in the esophagus. The prosthesis in this embodiment includes an annular body and a valve depending from the annular body for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents. A plurality of substantially rigid spikes are spaced along a circumference of the annular body adjacent one end thereof, preferably the proximal end. The valve depending from the annular body can be a sleeve valve which may include a plurality of magnets secured at a distal end to facilitate closure of the valve. The prosthesis may also include a gas permeable, and preferably liquid impermeable, membrane to allow retrograde permeation of gas therethrough. Each spike has a tip at a free end thereof and a base at the other end attached to the annular body. A dog is formed on each spike between the base and the tip. Each spike is outwardly bendable at the base between a retracted generally longitudinal alignment for insertion and a radially outwardly deployed alignment for fixation. Preferably, the spikes can include a chamfer at the base to facilitate the bending. A keeper is positioned on an exterior surface of the annular body for receiving the dogs and locking the respective spike in the deployed alignment. The annular body of the prosthesis can be threaded to allow engagement with a tool to perorally insert and/or remove the prosthesis from the esophagus. The prosthesis is configured to be implanted in the esophagus of a patient with gastroesophageal reflux disease (GERD), preferably when that patient''s esophagus is cancer free. [0013] In a further aspect, the present invention provides a tool for implanting the perorally implantable prosthesis. In this embodiment, the annular body is internally threaded and the spikes are attached to a proximal end of the annular body. The tool includes inner and outer tubes, a nipple secured to a distal end of the inner tube for releasably coupling the annular body, and a handle secured adjacent to a proximal end of the inner tube for manipulation of the tool. The inner tube and the outer tube are configured for advancement of the outer tube by rotating the outer tube with respect to the inner tube. A headpiece is secured to a distal end of the outer tube for bending the spikes outwardly into the deployed alignment by advancement of the headpiece into abutment with the nipple. A handle is preferably secured adjacent to a proximal end of the outer tube to facilitate rotation of the outer tube with respect to the first tube. Optionally, a plurality of transverse passages are formed in the headpiece in fluid communication with an annular space defined by an inner diameter of the headpiece, an outer diameter of the inner tube and annular seals on each end thereof. If present, the annular space is in turn in fluid communication with a vacuum source via a transverse bore in a wall of the inner tube and a central longitudinal passage through the inner tube, for drawing a lumen of the esophagus inwardly to facilitate penetration of the spikes. Optionally, a fiber optic cable is disposed within a central longitudinal passage of the inner tube for viewing the esophagus. [0014] In still another aspect of the invention, there is provided a method of using a tool to perorally implant an anti-reflux prosthesis in an esophagus. The method includes: (a) mounting the anti reflux valve prosthesis onto a headpiece of the tool; (b) positioning the anti-reflux valve prosthesis in the esophagus; (c) deploying a plurality of radial spikes of the prosthesis; (d) pulling a vacuum across a longitudinal passage of the tool; and (e) drawing a lumen of the esophagus inwardly to facilitate impaction of the spikes. Optionally the headpiece of the tool can be configured to be removable and replaced with a crown. The crown would be configured to assist in the peroral removal of the prosthesis from the esophagus. [0015] In still another aspect of the invention, there is provided a tool to perorally implant an anti-reflux prosthesis in an esophagus. The tool includes: (a) a means for mounting the anti reflux valve prosthesis onto a headpiece of the tool; (b) a means for positioning the anti-reflux valve prosthesis in the esophagus; (c) a means for deploying a plurality of radial spikes of the prosthesis; (d) a means for pulling a vacuum across a longitudinal passage of the tool; and (e) a means for drawing a lumen of the esophagus inwardly to facilitate impaction of the spikes. [0016] In still another aspect of the invention, there is provided a method of using a tool for implanting the anti-reflux valve prosthesis. The method includes: (a) perorally inserting and positioning the anti-reflux valve prosthesis into the esophagus; (b) deploying a plurality of spikes, the spikes depending radially from the anti-reflux prosthesis; and (c) impaling the esophagus upon the spikes to hold the prosthesis in place. Optionally, the method can include using a vacuum to assist in impaling the esophagus upon the spikes. [0017] Furthermore, another aspect of the invention provides for a tool to implant an anti-reflux prosthesis. The tool includes: (a) a means for perorally inserting and positioning the anti-reflux valve prosthesis into the esophagus; (b) a means for deploying a plurality of spikes, the spikes depending radially from the anti-reflux prosthesis; and (c) a means for penetrating the esophagus with the spikes to hold the prosthesis in place. [0018] In still another aspect of the invention, there is provided a method of using a tool for implanting an anti-reflux valve prosthesis. The method includes: (a) releasably engaging a nipple of the tool with an annular body of the prosthesis, the prosthesis having a plurality of retractable embedment spikes; (b) perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction; (c) extending the spikes fully outwardly into a deployed alignment for engagement with a lumen of the esophagus; (d) uncoupling the nipple from the prosthesis; and (e) withdrawing the tool from the esophagus. Furthermore, the method can optionally include actuating a vacuum source to draw the wall of the lumen inwardly and facilitate engagement of the spikes. [0019] In still another aspect of the invention, there is provided a tool for implanting an anti-reflux valve prosthesis. The tool includes: (a) a means for releasably engaging a nipple of the tool with an annular body of the prosthesis, the prosthesis having a plurality of retractable embedment spikes; (b) a means for perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction; (c) a means for extending the spikes fully outwardly into a deployed alignment for engagement with a lumen of the esophagus; (d) a means for uncoupling the nipple from the prosthesis; and (e) a means for withdrawing the tool from the esophagus. [0020] A further aspect is the provision of a tool for extracting the anti-reflux prosthesis wherein the prosthesis includes an annular body and extended radial spikes therefrom. The tool includes an inner tube and an outer tube, with the tubes being generally concentrically aligned, an nipple secured to a distal end of the inner tube, the nipple configured to be releasably coupled with the annular body, and a crown secured to a distal end of the outer tube, the crown having a plurality of tangentially projecting shoes to receive and retract the extended radial spikes. Optionally, the outer tube of the tool can be configured to be advanced or retracted as the outer tube is rotated with respect to the inner tube. The tool can also comprise a handle secured to a proximal end of the inner tube for manipulation thereof. The tool can also include a second handle secured adjacent to a proximal end of the outer tube to facilitate movement of the outer tube with respect to the inner tube. The tool can optionally include a fiber optic cable disposed within a central longitudinal passage of the inner tube for viewing the esophagus. The tool can optionally include an overtube having a shield of enlarged diameter at a distal end thereof, wherein the overtube is slidable over the outer tube to receive the plurality of spikes to facilitate removal of the prosthesis from the esophagus. The shield may optionally be tapered from a larger diameter at a distal end to a smaller diameter at a proximal end. The crown may optionally be configured to be removable and replaced with a headpiece that is configured to assist in reinstalling the prosthesis into the esophagus. [0021] A further aspect of the invention involves a method for using a tool to extract an anti-reflux valve prosthesis from an esophagus. The method includes: (a) perorally inserting the tool into the esophagus, wherein the tool comprises a nipple and a crown; (b) engaging the nipple into an annular body of the prosthesis, wherein the prosthesis includes a plurality of extended embedment spikes; (c) advancing the crown with respect to the nipple, the crown configured to retract the embedment spikes; and (d) removing the tool and engaged prosthesis from the esophagus. Optionally, the method can include advancing a shield over the spikes to place the spikes into a retracted position. Continue reading about Perorally removeable anti-reflux valve implantation... Full patent description for Perorally removeable anti-reflux valve implantation Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Perorally removeable anti-reflux valve implantation patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Perorally removeable anti-reflux valve implantation or other areas of interest. ### Previous Patent Application: Laminar skin-bone fixation transcutaneous implant and method for use thereof Next Patent Application: Suturable adhesion-preventing membrane Industry Class: Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor ### FreshPatents.com Support Thank you for viewing the Perorally removeable anti-reflux valve implantation patent info. IP-related news and info Results in 0.72343 seconds Other interesting Feshpatents.com categories: Canon USA , Celera Genomics , Cephalon, Inc. , Cingular Wireless , Clorox , Colgate-Palmolive , Corning , Cymer , 174 |
 * Protect your Inventions * US Patent Office filing 
PATENT INFO |
|
