ARTICLE, SYSTEM, AND METHOD FOR SECURING MEDICAL DEVICES TO TREAT OBESITY, GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) AND IRRITABLE BOWEL SYNDROME (IBS) REVERSIBLY

• US 20080228030A1
• Filed: 05/21/2007
• Published: 09/18/2008
• Est. Priority Date: 05/19/2006
• Status: Active Grant

• Current Assignee: Norman Godin
• Original Assignee: Norman Godin
• Inventors: Godin, Norman
• Granted Patent: US 8,556,934 B2
• Time in Patent Office: Days
• US Class Current: 600/106
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

Abstract

A medical staple formed from a nitinol wire, the staple having two elongated arms which extend upwardly and outwardly from a central loop in two opposing generally semicircular courses forming an arc extending upwardly and outwardly and an end second comprising a sharpened endpoint, the endpoint being the arms bendable under resistance, is disclosed. In some embodiments the arms extend upwardly on a parallel course and then outwardly. The material is preferably an alloy with hyperelastic characteristics. The staples are placed in a flexible endoscope and a lumen catheter within the endoscope, using a hook or forceps in the lumen catheter having a distal end in the lumen of the catheter and the staple distal to the forceps in folded configuration with the arms folded inward in the lumen catheter, positioning the distal end of the lumen catheter at a location in the patient'"'"'s gastrointestinal tract where stapling is desired, moving the forceps distally so as to force the staple forward out of the lumen catheter and cause the end points to pierce the patient'"'"'s inner wall of the gastrointestinal tract.

Claims

1. A medical staple formed from a metal alloy wire, the staple having two elongated arms and a central loop, each of the arms normally extending from the loop in two opposing generally semicircular courses extending upwardly and outwardly from the loop, each arm having an end comprising a sharpened endpoint, the arms bendable under resistance and resuming their original position upon release.

2. The staple of claim 1 wherein the metal alloy is a nickel-titanium which has hyperelastic characteristics.

3. The staple of claim 2 adapted to easily fold so as to fit within a tube having an internal diameter of about 2 mm to 4 mm so as to pass in the working channel of a flexible endoscope and to unfold when pushed out of the tube at a location in a body.

4. The article of claim 1 adapted to staple a medical device to the inner mucosa of the gastro-intestinal tract of a patient.

5. The article of claim 3 adapted so that the end points can pierce through a medical device and inner mucosa so as to staple the medical device to the inner wall in a position so that the endpoints are at least 0.5 mm above the top of the central loop and so that the endpoints to not pierce back into the gastrointestinal tract.

6. The article of claim 1, wherein the arms extend upwardly from the loop first in a parallel direction and then outwardly.

7. The article of claim 1, wherein the endpoints are at least about 0.5 mm above the top of the loop.

8. The article of claim 1 wherein the arc of each arm has a length of 5 to 15 mm and a radius of about 1 to 3 mm, each parallel section is about 1 to 5 mm, each end section curved and the endpoints at lease 0.5 mm above the top of the central loop.

9. The article of claim 1 adapted to staple a tubular gastrointestinal anti-reflux device comprising a ring to a lower esophagus or hiatus hernia so that the loop is on the inner side of the ring and the arms extend from the loop, through the tube or ring, and through the lower esophagus or hiatus hernia.

10. A medical device comprising a pair of the staples of claim 1 joined by a small ring adapted to pleat the cardia of the stomach longitudinally or transversally to treat mild GERD.

11. The article of claim 1 adapted to staple an anti-obesity small reservoir at the lower part of the esophagus.

14. The article of claim 1 comprising a plurality of pairs of staples adapted to create an endoscopically placed horizontal gastroplasty that is reversible by pulling out the staples and creating a small reservoir for food at the cardia.

15. The article of claim 1 adapted to reversibly staple an inner gastric and intestinal by-pass tube at the lower esophagus to treat obesity.

16. The article of claim 1 adapted to reversibly staple a lead of a pace-maker or pace-setter that stimulates the stomach, duodenum and jejunum to contract and help the alimentary bolus in the by-pass tube to progress.

17. The article of claim 1 adapted to attach a probe to a patient'"'"'s colon.

18. A medical staple according to claim 1 coated with parylene sufficient to protect the staple from attack by gastric fluids and undesirable release of nickel.

19. A medical staple according to claim 1 coated or treated with PTFE sufficient to function as a temperature insulant.

20. A surgical method comprising providing a flexible endoscope and a flexible lumen catheter within the endoscope, a hook or forceps having a distal end in a lumen of the catheter and a medical staple according to claim 1 distal to the forceps in folded configuration with the arms folded inward in an outer catheter, positioning the distal end of the hook or forceps at a location in the patient'"'"'s gastrointestinal tract where stapling is desired, moving the hook or forceps distally so as to force the staple forward and cause the end points to pierce the patient'"'"'s inner mucosa and staple to the wall of the gastrointestinal tract.

21. The method of claim 20 comprising stapling a gastrointestinal anti-reflux device (GARD) having a collapsible ring, the method in a hiatus hernia at the juncture of the patient'"'"'s esophagus and stomach at a plurality of locations.

22. The method of claim 20 wherein the staple is constructed of a nickel-titanium alloy having the property of hyperelasticity.

23. The method of claim 20 wherein the staples are constructed of absorbable material and the device is a sensor designed for temporary implantation in the patient.

24. The method of claim 20 wherein the flexible catheter has a needle comprising a stopper so as to predetermine the depth of penetration of the needle before the staple is released and preventing penetration of the needle beyond the wall of the alimentary tract and causing a lesion to a nearby organ.

25. The method of claim 20 wherein the device is another staple and the staples are used in pairs for pleating the gastric mucosa, closure of tears or perforations, stapling of stomach or bowel.

26. The method of claim 20 wherein the device is a pacemaker and the staples are used for placement of pace-maker leads and electrodes with a rigid trocar through the abdominal wall into the stomach or from outside the stomach inward.

27. The method of claim 20 comprising implanting a staple in the alimentary tract having an electrical lead connected to a pace-setter for pacing the alimentary tract.

28. The method of claim 20 comprising repairing a tear in a stomach or esophagus by implanting a pair of the staples, one on each side of the tear, and then using surgical thread to draw the two staples toward each other.

12. A system comprising a plurality of pairs of staples adapted to create an endoscopically placed vertical banding gastroplasty that is reversible by pulling out the staples.

13. The system of claim 12 comprising a plurality of pairs of staples adapted to create an endoscopically placed vertical banding gastroplasty that is reversible by pulling out the staples and to which an inner by-pass tube is stapled at the lower end of the intestine to create an internal intestinal by-pass.

29. An article useful for implanting a medical device comprising an electrical lead, a flexible joining member, and a terminal staple.