US6558429B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof
Assignee: Reflux Corp
•
Filing: 2001-03-26
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Granted: 2003-05-06
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Expires: 2021-03-26
Abstract
Abstract Disclosed is an instrument, valve prosthesis and procedure for the minimally invasive implantation of a sutureless anti-reflux valve in a patient for the treatment of gastroesophageal reflux disease. Self-anchoring or stapleable one-way anti-reflux valve prostheses are provided, which may be implanted proximate a patient's gastroesophageal junction without open or laparoscopic surgery. An instrument for the peroral insertion, positioning and fixing of the valve prosthesis to the tissue of the esophagus is described for the implantation of either the self-anchoring or stapleable prosthesis.
Inventors
- 👤 Thomas V. Taylor
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 20:58
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/0004; A61F2/02; A61F2/24; A61F2/2476; A61F2/04; A61F2002/044
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
202 words
A peroral prosthesis system for treatment of gastroesophageal reflux disease in a patient comprising: an anti-reflux valve prosthesis comprising: a mounting ring, a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impending the passage of gastric content, and a plurality of anchors extending radially outwardly from the mounting ring, wherein the anchors comprise a radial array of straight, orthogonal spikes for piercing and engaging the lumen wall of the esophagus; and a peroral implantation tool for perorally inserting and positioning the prosthesis at a distal end of the lumen of an esophagus, and fixing the prosthesis to the lumen wall of the esophagus, said tool comprising: an overtube for peroral insertion adjacent to a gastroesophageal junction, having a collar at a distal end and a handle at a proximal end; a compression collar integral with the distal end of the overtube for releaseably receiving the mounting ring in a compressed configuration; a hollow stylet slidably indwelling in the length of the overtube; and a balloon attached to a distal end of the stylet received in the compression collar, and communicating with a hollow of the stylet, and inflatable by pressurizing the hollow of the stylet.
Claim 2
Dependent Claim
202 words
A peroral prosthesis system for treatment of gastroesophageal reflux disease in a patient comprising: an anti-reflux valve prosthesis comprising: a mounting ring, a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impending the passage of gastric content, and a plurality of anchors extending radially outwardly from the mounting ring, wherein the anchors comprise a radial array of straight, orthogonal spikes for piercing and engaging the lumen wall of the esophagus; and a peroral implantation tool for perorally inserting and positioning the prosthesis at a distal end of the lumen of an esophagus, and fixing the prosthesis to the lumen wall of the esophagus, said tool comprising: an overtube for peroral insertion adjacent to a gastroesophageal junction, having a collar at a distal end and a handle at a proximal end; a compression collar integral with the distal end of the overtube for releaseably receiving the mounting ring in a compressed configuration; a hollow stylet slidably indwelling in the length of the overtube; and a balloon attached to a distal end of the stylet received in the compression collar, and communicating with a hollow of the stylet, and inflatable by pressurizing the hollow of the stylet.
Claim 3
Dependent Claim
14 words
The system of claim 1 wherein the mounting ring comprises a compressible memory material.
Claim 4
Dependent Claim
10 words
The system of claim 1 wherein the spikes are barbed.
Claim 5
Dependent Claim
18 words
The system of claim 1 wherein the anchors comprise an array or at least 8 of the spikes.
Claim 6
Dependent Claim
34 words
A kit for treating gastroesophageal reflux disease in a patient comprising: a package; the peroral prosthesis system of claim 1 housed within the package; and optionally, instructions for use of the peroral prosthesis system.
Claim 7
Dependent Claim
27 words
The invention of claim 5 wherein the valve is selected from sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disc valves, double hinged valves and heart valves.
Claim 8
Dependent Claim
27 words
The invention of claim 1 wherein the valve is selected from sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disc valves, double hinged valves and heart valves.
Claim 9
Dependent Claim
87 words
A peroral anti-reflux valve prosthesis comprising: a mounting ring of a compressible memory material; an array of tissue anchors extending radially outward from the mounting ring, the anchors having spikes for piercing and engaging the lumen wall of an esophagus and fixing the mounting ring in the lumen of the esophagus, wherein the spikes are straight and orthogonal with respect to the mounting ring; and a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impeding the passage of gastric content.
Claim 10
Dependent Claim
87 words
A peroral anti-reflux valve prosthesis comprising: a mounting ring of a compressible memory material; an array of tissue anchors extending radially outward from the mounting ring, the anchors having spikes for piercing and engaging the lumen wall of an esophagus and fixing the mounting ring in the lumen of the esophagus, wherein the spikes are straight and orthogonal with respect to the mounting ring; and a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impeding the passage of gastric content.
Claim 11
Dependent Claim
15 words
The prosthesis of claim 8 wherein the anchors comprise a radial array of the spikes.
Claim 12
Dependent Claim
10 words
The prosthesis of claim 8 wherein the spikes are barbed.
Claim 13
Dependent Claim
18 words
The prosthesis of claim 8 wherein the anchors comprise an array of at least 8 of the spikes.
Claim 14
Dependent Claim
16 words
The prosthesis of claim 8 wherein the valve comprises a skirt depending from the mounting ring.
Claim 15
Dependent Claim
22 words
The prosthesis of claim 12 further comprising a plurality of longitudinal stays secured to the skirt for inhibiting inversion of the valve.
Claim 16
Dependent Claim
124 words
A gastroesophageal prosthesis implantation tool for peroral implantation of the spiked prosthesis of claim 6 , comprising: an overtube for peroral insertion to a position adjacent a gastroesophageal junction, having a compression collar at a distal end and a handle at a proximal end with slots for receiving the spikes; wherein the compression collar is integral with the distal end of the overtude for releaseably receiving the mounting ring in a compressed configuration; a hollow stylet slidably indwelling in the length of the overtube; and a balloon attached to a distal end of the stylet received in the compression collar, communicating with a hollow of the stylet, inflatable by pressurizing the hollow of the stylet; and a handle for manipulating and operating the tool.
Claim 17
Dependent Claim
27 words
The invention of claim 14 wherein the valve is selected from sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disc valves, double hinged valves and heart valves.
Claim 18
Dependent Claim
27 words
The invention of claim 8 wherein the valve is selected from sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disc valves, double hinged valves and heart valves.
Claim 19
Dependent Claim
136 words
A minimally invasive method for surgically treating gastro-esophageal reflux disease in a patient with a peroral implantation system comprising as anti-reflux valve prosthesis and an implantation tool, the prosthesis comprising a mounting ring, a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impeding the passage of gastric content, and a plurality of anchors extending radially outwardly from the mounting ring, comprising the steps of: perorally inserting the prosthesis received in a distal end of the implantation tool into an esophagus; positioning the prosthesis adjacent to an esophageal junction; perforating a lumen wall of the esophagus with the anchors to fix the prosthesis in place in the esophagus of the patient; removing the implantation tool from the esophagus; and leaving the valve prosthesis in situ to treat gastro-esophageal reflux disease.
Claim 20
Dependent Claim
136 words
A minimally invasive method for surgically treating gastro-esophageal reflux disease in a patient with a peroral implantation system comprising as anti-reflux valve prosthesis and an implantation tool, the prosthesis comprising a mounting ring, a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impeding the passage of gastric content, and a plurality of anchors extending radially outwardly from the mounting ring, comprising the steps of: perorally inserting the prosthesis received in a distal end of the implantation tool into an esophagus; positioning the prosthesis adjacent to an esophageal junction; perforating a lumen wall of the esophagus with the anchors to fix the prosthesis in place in the esophagus of the patient; removing the implantation tool from the esophagus; and leaving the valve prosthesis in situ to treat gastro-esophageal reflux disease.
Claim 21
Dependent Claim
27 words
The invention of claim 17 wherein the valve is selected from sleeve valves, monocuspid, bicuspid and tricuspid valves, hinged disc valves, double hinged valves and heart valves.
Claim 22
Dependent Claim
24 words
The method of claim 17 wherein the anchors comprise a radial array of at least 8 straight spikes extending orthogonally from the mounting ring.
Claim 23
Dependent Claim
9 words
The method claim 19 wherein the spikes are barbed.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-05-05 | 2006-11-04 | 2007-05-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-05-05 | 2010-11-04 | 2011-05-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-05-05 | 2014-11-04 | 2015-05-06 | $7700.00 | Window Closed / Lapsed |