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

• US 6,254,642 B1
• Filed: 12/09/1997
• Issued: 07/03/2001
• Est. Priority Date: 12/09/1997
• Status: Expired due to Fees

• Current Assignee: Juan Fernandez, Reflux Corporation
• Original Assignee: Juan Fernandez, Julia Glueck, Ken Fukunaga, Yukihiko Nose
• Inventors: Taylor, Thomas V.
• Primary Examiner(s): Nguyen, Dinh X.
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US08/987,693
• Time in Patent Office: 1,302 Days
• Field of Search: 623/12, 623/2, 623/11, 606/151, 606/108, 606/153, 606/154, 606/215
• US Class Current: 623/23.64
• 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 an 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 made of an expandable, compressible memory material;

an anchor comprising staples for fixing the mounting ring in the lumen of the esophagus; and

a one-way valve depending from the mounting rings for allowing orthograde passage of swallowed material, and impeding the passage of gastric content; 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, comprising an intralumenal, circular surgical stapler, having an annular space connected to a vacuum source and a prosthesis holder.

2. The system of claim 1 wherein the stapler comprises a head, an anvil axially positionable from the head, a perforated tube for drawing the lumen of the esophagus between the head and the anvil, and a holder for disengageably receiving a prosthesis mounting ring.

3. The system of claim 2 wherein the stapler comprises:

a stapler head for dispensing and driving staples;

an anvil having a circular surface opposing the stapler head, and inset with a channel for receiving and holding the mounting ring, and a plurality of notches radially disposed in pairs on opposite sides of the channel for receiving and bending staple points; and

staples disposed in the head with points positioned across the mounting ring to engage the notches on the anvil surface.

4. The system of claim 2 wherein the stapler comprise:

a stapler head for dispensing and driving staples, having a surface inset with a channel for receiving and holding a mounting ring;

staples, having staple points radially disposed across the mounting ring; and

an anvil, having a circular surface opposing the stapler head, and a plurality of notches radially disposed in pairs for receiving and bending the staple points.

5. The system of claim 2 wherein the stapler comprises:

a stapler head for driving staples, having a surface inset with a channel for receiving and holding a mounting ring;

a mounting ring, held in the channel, and having staple points integrally incorporated therein and radially projecting from the mounting ring; and

an anvil, having a circular surface opposing the stapler head, and a plurality of notches disposed for receiving and bending the staple points.

7. The peroral prosthesis system of claim 1 wherein the prosthesis implantation tool comprises:

a shaft having a distal stapler end and a proximal handle end;

the intralumenal, circular surgical stapler connected to the distal end of the shaft, the stapler having a head, an anvil axially positionable from the head, the vacuum source adapted for drawing the lumen of the esophagus into the annular space between the head and the anvil, and the prosthesis holder adapted for disengageably receiving the mounting ring;

a handle connected to the proximal end of the shaft, for receiving a vacuum and for manipulating and operating the stapler; and

the shaft having internally disposed means for connecting the operation of the handle with the operation of the stapler.

8. The system of claim 7 wherein the stapler further comprises:

a stapler head for dispensing and driving staples;

an anvil having a circular surface opposing the stapler head, and inset with a channel for receiving and holding the mounting ring, and a plurality of notches radially disposed in pairs on opposite sides of the channel for receiving and bending staple points; and

staples disposed in the head with points positioned across the mounting ring to engage the notches on the anvil surface.

9. The system of claim 7 wherein the stapler further comprises:

a stapler head for dispensing and driving staples, having a surface inset with a channel for receiving and holding a mounting ring;

staples, having staple points radially disposed across the mounting ring; and

an anvil, having a circular surface opposing the stapler head, and a plurality of notches radially disposed in pairs for receiving and bending the staple points.

10. The system of claim 7 wherein the stapler further comprises:

a stapler head for driving staples, having a surface inset with a channel for receiving and holding a mounting ring;

the mounting ring, held in the channel, and having staple points integrally incorporated therein and radially projecting from the mounting ring; and

an anvil, having a circular surface opposing the stapler head, and a plurality of notches disposed for receiving and bending the staple points.

11. A minimally invasive method for surgically treating gastro-esophageal reflux disease in a patient with the system of claim 1 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;

fixing 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.

12. 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.

13. The kit of claim 12 wherein the package and contents are sterile.

17. The invention of any of claim 1, 14, 15, 16 wherein the valve is selected from sleeve valves.

6. An anti-reflux valve prosthesis comprising:

a mounting ring;

an array of at least one row of tissue anchors presenting at least 8 points extending outward from the mounting ring, in the direction substantially parallel to the esophagus the anchors having staple points for engaging the lumen wall of an esophagus and fixing the mounting ring in the lumen of the esophagus; and

a one-way valve depending from the mounting ring, for allowing orthograde passage of swallowed material, and impeding the passage of gastric content.

14. The anti-reflux valve prosthesis of claim 6 wherein the mounting ring comprises a helical spring and a biologically inter coating.

15. The anti-reflux valve prosthesis of claim 14 wherein the anchors comprise a crosspiece between pairs of staple points and wherein the crosspieces are disposed within the coating substantially tangentially with respect to the mounting ring.

16. The anti-reflux valve prosthesis of claim 14 wherein the anchors comprise a crosspiece between pairs of staple points and wherein the crosspieces are disposed transversely through the coating so that a pair of respective staple points on either end of each crosspiece are disposed on opposite sides of the coating.