Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof

• US 6,558,429 B2
• Filed: 03/26/2001
• Issued: 05/06/2003
• Est. Priority Date: 12/09/1997
• Status: Expired due to Fees

• Current Assignee: Reflux Corporation
• Original Assignee: Reflux Corporation
• Inventors: Taylor, Thomas V.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/681,366
• Publication Number:
  US 20010020190A1
• Time in Patent Office: 771 Days
• Field of Search: 623/23.68, 623/1.24, 623/2.26, 623/2.1, 623/1.26
• US Class Current: 623/23.68
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets

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.

Claims

1. 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.

2. The system of claim 1 wherein the mounting ring comprises a compressible memory material.

3. The system of claim 1 wherein the spikes are barbed.

4. The system of claim 1 wherein the anchors comprise an array or at least 8 of the spikes.

5. 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.

6. 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.

7. 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.

14. 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.

15. 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.

8. 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.

9. The prosthesis of claim 8 wherein the anchors comprise a radial array of the spikes.

10. The prosthesis of claim 8 wherein the spikes are barbed.

11. The prosthesis of claim 8 wherein the anchors comprise an array of at least 8 of the spikes.

12. The prosthesis of claim 8 wherein the valve comprises a skirt depending from the mounting ring.

13. The prosthesis of claim 12 further comprising a plurality of longitudinal stays secured to the skirt for inhibiting inversion of the valve.

16. 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.

17. 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.

18. 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.

19. The method of claim 17 wherein the anchors comprise a radial array of at least 8 straight spikes extending orthogonally from the mounting ring.

20. The method claim 19 wherein the spikes are barbed.