Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Hollow or tubular part or organ
Reexamination Certificate
2001-03-26
2003-05-06
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Hollow or tubular part or organ
Reexamination Certificate
active
06558429
ABSTRACT:
BACKGROUND OF INVENTION
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 in the treatment of gastroesophageal reflux disease in a patient.
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 go on to produce esophageal cancer. Current methods of treating GERD include powerful antacid medication therapies and surgical interventions.
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.
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.
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.
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. However, such 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.
In view of the preference for minimally invasive forms of surgery there is a need in the art for GERD treatments which can be fully accomplished without surgically compromising the integrity of a patient's body membrane. Applicant has invented a peroral procedure for the insertion and implantation of an anti-reflux valve prosthesis that can address this need. It benefits the field to have an alternative prosthetic device and method that can be practiced to position and fix an anti-reflux prosthesis in place in the esophagus without resort to surgical incision or laparoscopy.
SUMMARY OF INVENTION
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 an 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. Peroral installation of an anti-reflux prosthesis has the potential benefits of reducing the trauma, morbidity and hospital stay associated with implantation of anti-reflux valve prostheses relative to other surgical techniques. Furthermore, a system permitting the implantation of a standardized anti-reflux valve in an accurate and reproducible manner has the potential for providing more consistent clinical results than can be achieved with other techniquemethods of treatment.
The prosthesis system comprises an anti-reflux valve prosthesis and a peroral implantation tool for positioning and fixing the prosthesis proximate the distal end of the esophagus of a patient being treated for GERD. The present invention provides a prosthesis that is self-anchoring, having a mounting ring preferably constructed of a memory material supporting an anti-reflux valve. The memory material allows the mounting ring to be acted upon and deformed, but to return to its original shape when the deformation force is removed. The mounting ring is deformed during installation, but automatically returns to its original ring shape upon release. Also, the mounting ring incorporates tissue anchors which fixably engage the adjacent lumenal tissue of the esophagus to hold the prosthesis in place after installation. An anti-reflux valve is supported by the mounting ring. The anti-reflux valve is a normally closed, compliant one-way valve integral with the mounting ring. A variety of one-way valve types are practicable in the present invention by one of ordinary skill in the art. These include sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disk valves, double hinged valves and heart valves. Typically, the compliant part of a valve has structural supports to prevent the valve from inverting.
A feature of one installation tool is a removable compression collar for encircling the mounting ring and holding it in a compressed condition and for releaseably housing the prosthesis during positioning and prior to implantation. The compression collar is integral with one end of an overtube. The overtube is of a smooth and optionally flexible construction. The distal end of the overtube receives and holds the prosthesis in a compressed configuration during positioning of the prosthesis in the lumen of the esophagus. A further feature of the installation tool is a hollow stylet tube indwelling and slidable in the length of the overtube from the prosthesis at the distal end of the overtube to the handle at the proximal end of the overtube. At its distal end, the stylet is fitted with a normally deflated balloon which is inflatable by passing a gas or liquid (under appropriate pressure) through the hollow of the stylet tube and into the balloon. The deflated balloon is positioned and disengaged from the overtube in concert with the prosthesis. After disengagement, the balloon is inflated to exert pressure on the inside surface of the mounting ring of the prosthesis. The recovery of the memory material of the released mounting ring and the force exerted by the inflated balloon cause the tissue anchors of the mounting ring to engage with the lumenal tissue of the esophagus.
Another aspect of the present invention is a method for using the above tool to implant an anti-reflux valve prosthesis in a patient with GERD. In operation, a compressed prosthesis, h
Lundeen Daniel N.
Lundeen & Dickinson LLP
McDermott Corrine
Reflux Corporation
Stewart A.
LandOfFree
Perorally insertable gastroesophageal anti-reflux valve... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Perorally insertable gastroesophageal anti-reflux valve..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Perorally insertable gastroesophageal anti-reflux valve... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3066024