Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
  • A61F5/0079—Pyloric or esophageal obstructions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3478—Endoscopic needles, e.g. for infusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00818—Treatment of the gastro-intestinal system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00818—Treatment of the gastro-intestinal system
  • A61B2017/00827—Treatment of gastro-esophageal reflux
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/958—Inflatable balloons for placing stents or stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/044—Oesophagi or esophagi or gullets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
  • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1042—Alimentary tract
  • A61M2210/1053—Stomach
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

• the presently disclosed technology relates to the field of medical devices, particularly medical devices relating to gastroenterology, and more specifically to apparatus and methods of implanting gastroesophageal anti-reflux devices (“GARDSTM”) and or obesity devices in an esophagus.
• GARDSTM gastroesophageal anti-reflux devices
• GARDTM can also refer to a gastro-intestinal anti-reflux device.
• GARDSTM are thin walled tubular medical devices placed in the esophagus.
• GARDs can be placed in the esophagus or extend from the esophagus into the stomach with a top ring that is calibrated precisely to the millimeter to the diameter of the esophagus with a calibration balloon that is passed through the working channel of the endoscope at the level of the lower third of the body of the esophagus under visual control of the gastroscope to determine the diameter of the esophagus once opened.
• the calibration balloon can measure the diameter of the esophagus.
• the calibration balloon is reopened to the same size measured in the esophagus and a calibration card (or a calibration block that has the depth of the vertical part of the balloon that is parallel to the balloon catheter (see 38 in FIGS. 15B and 15C), which is usually 1 to 2 centimeters deep (approximately 0.5 to 1 inch deep thick)).
• Sizing holes can be used to determine to the millimeter the size of the GARDTM device needed for a given patient.
• the tube of the OB-GARDTM does not require such surgery as the OB-GARDTM is placed through the mouth of the patient.
• a ring at the top, or proximal end, of the device is placed in the lower third of the esophagus, more precisely in the last 5 cm of the esophagus above the Z line or esogastric junction.
• the presence or absence of a hiatus hernia does not affect the use of the GARDTM family of devices as it can in other endoscopic treatments available.
• endoscopic devices compared to surgery is that the peri-operative and postoperative morbidity and mortality could be further decreased as well as cost and we could add new aspects to the treatment of type 2 diabetes for the more severe cases thereby reconstituting a more normal metabolism and avoiding long-term increasing additions of high insulin with their potential complications.
• endoscopic treatment of reflux and/or obesity as both are often linked will give more flexibility in the treatment by changing the length of the devices if needed (shorter ones if patients lose weight but not enough weight to remove all the devices or longer devices if the patient does not lose enough weight).
• diet and participation of the patient is essential as it is known that cultural habits attached to food are of the utmost importance.
• GERD will often appear when patients gain weight. Often as little as a 5 to 10 pound (approximately 3 kg to 5 kg) can be sufficient to cause severe GERD that will improve with weight loss.
• the GARDTM is the only treatment that addresses both obesity and weight loss.
• the injection device can include the catheter having the balloon arranged to block the catheter centrally in the esophagus when expanded so that an injection catheter will reach the esophageal wall at a selected angle for injection of the toxin at a selected depth in the muscular layer of the esophagus.
• a method for preventing contraction and peristaltic wave action of an esophagus that causes displacement of a medical device from an intended location towards or into the stomach can include injecting botulinum toxin in the wall of the esophagus at the level where the medical device will be placed.
• This method can include use of any one of the systems as described herein.
• a system can include a GARDTM having a ring maintained in a folded state with a thread tied with a draw string knot.
• the draw string knot can optionally be adapted to be untied by pulling on a string from a distance, thereby allowing the ring to unfold.
• the ring unfolds to reach the wall of the esophagus.
• the size of the ring is calibrated to the size and location of the esophagus.
• a system can be configured to prevent contraction or peristaltic wave action of an esophagus of a patient causing displacement of a gastroesophageal anti-reflux device having a ring used to diagnose and manage refractory Gastroesophageal Reflux Disease (GERD) from an intended location in the esophagus towards or into the stomach.
• the system can include a catheter having an opening at a proximal end thereof, a port spaced-apart from the opening and located near a proximal end of the catheter, and a plurality of spaced-apart openings in a body thereof. Threads can be configured to enter the catheter at the port and exit the catheter at one of the plurality of spaced-apart openings. Each thread can be configured to be removably attached to the gastroesophageal anti-reflux device.
• FIGs. 1A-1B are cross-sectional views of a portion of human anatomy including an esophagus and stomach with a perspective view of a GARDTM device according to embodiments of the presently disclosed technology, illustrating the position of the GARDTM device in the lower esophagus.
• Fig. 1A shows a smooth tubular part 4A of the GARDTM device.
• Fig. IB shows a lamellar tubular part 4B of the GARDTM device.
• FIG. 2 is an enlarged perspective view of a ring of the GARDTM of one embodiment of the presently disclosed technology and the sites of injection of the botulinum toxin, illustrating a portion of an esophagus in cross-section.
• Fig. 3 is a cross-sectional view from above of the top of the ring as seen with the gastroscope placed in the esophagus.
• FIG. 4 is a side perspective view of an injection balloon catheter of one embodiment of the presently disclosed technology with guiding tubes, before inflation at introduction, partially in cross-section.
• FIG. 5A is a side perspective view of an injection balloon catheter of one embodiment of the presently disclosed technology with the balloon inflated.
• Fig. 5B is a side perspective view of a balloon expander of one embodiment of the presently disclosed technology with three arms spread.
• Fig. 6 is a side perspective view of an injection balloon catheter of one embodiment of the presently disclosed technology with guiding tubes, before inflation, which is a variant of Fig 4 but with a triangular balloon.
• Fig. 7 is a side perspective view of the device of Fig. 6, wherein the triangular balloon is inflated and pushes up the arm of the balloon expander and the end of the guiding tube.
• FIG. 8A is a side perspective view of a GARDTM Introducer with a Botulinum toxin injection catheter of one embodiment of the presently disclosed technology.
• Fig. 8B is a cross-sectional view of the central catheter of Fig. 8A.
• Fig. 8C is cross-sectional view of the central catheter of Fig. 8A with four tubes.
• FIG. 9 is a side perspective view of the device of one embodiment of the presently disclosed technology with threads 25A,B,C pulled out to release the GARDTM.
• Fig. 10 illustrates the device of Fig. 9 with the threads 25A,B,C completely pulled out of the catheter.
• Fig. 11 illustrates a combination of a top small triangular, or conical balloon 23 used to spread the arms of the arm expander 22 and the guiding tube 18 and a bottom oval balloon 16 to help deploy the ring of the GARDTM of one embodiment of the presently disclosed technology.
• Fig. 12A is a side perspective view of an alternative GARDTM Introducer with a Botulinum toxin injection catheter and with a guide wire according to one embodiment of the presently disclosed technology.
• Fig. 12B is a cross-sectional view of the central catheter of Fig. 12A taken from line 12B- 12B of Fig. 12A.
• Fig. 12C is a cross-sectional view of the central catheter of Fig. 12A taken from line 12C- 12C of Fig. 12A.
• Fig. 13 is a side perspective view of the GARDTM Introducer of Fig. 12A with threads untied.
• Fig. 14 is a side perspective view of the GARDTM Introducer of Fig. 12A without the threads or after the threads have been removed from the catheter.
• Fig. 15A is a perspective view of a guide wire within a balloon catheter and a deflated balloon according to one embodiment of the presently disclosed technology.
• Fig. 15B is a perspective view of a guide wire partially surrounded by an inflated balloon and a syringe attached to the balloon catheter and configured to inject air according to one embodiment of the presently disclosed technology.
• Fig. 15C is a perspective view of an embodiment of the presently disclosed technology.
• Fig. 16 shows a calibration card or block at ⁇ i scale according to one embodiment of the presently disclosed technology.
• Fig. 17A is a cross-sectional view of an esophagus, with a GARDTM calibrated ring, a helical spring in the middle of the silicone ring, and a calibration balloon therein.
• Fig. 17B is a cross-sectional view of an esophagus, with a ring of the DM1, DM2, or DM3 model with a helical spring.
• Fig. 17C is a cross-section view of an esophagus wherein a curve therein has disappeared.
• a cell means one cell or more than one cell.
• Figs. 1A and IB show the position of the GARDTM device in the lower esophagus 1.
• the tubular part 4A (smooth) or 4B (lamellar) of the GARDTM device extends into the stomach 2A, below a hiatus hernia 2B which is part of stomach 2A sliding above the diaphragm 6 in the lower chest as the chest is above the diaphragm.
• a ring 3A having a top 3C of the GARDTM device includes a helical spring 3B in the lower esophagus 1.
• the level of the Z line 5 is at the junction of gastric and esophageal mucosa. Diaphragm 6 is shown above stomach 2A.
• Figs. 1A-1B show a GARDTM device which includes a ring 3A which includes top 3C and helical spring 3B in the lower esophagus and 3C top of the ring, the ring 3 A being placed above the level of the Z line 5, which is shown as an irregular line located just at the junction of gastric and esophageal mucosa in the lower esophagus 1.
• the tubular part 4A or 4B of the GARDTM device extends into stomach 2A.
• Diaphragm 6 is located between the lower part of the hiatus hernia 2B and the stomach 2A.
• the site 7 of the first injections are about 1 cm above the GARDTM ring 3A. Area of enlargement 2 from Figs. 1A and IB is shown in Fig. 2.
• Fig. 2 is an enlarged view of the ring 3A of the GARDTM and the sites 10 of injection indicated by arrows 7 of the botulinum toxin in the muscular layer 9 of the wall of the esophagus.
• Top 3C of ring 3 A and helical spring 3B are illustrated.
• Mucosa and submucosa 8 and muscular layer 9 of esophagus 10 are also illustrated.
• the botulinum toxin is injected in the muscular layer 9, not in the mucosa or submucosa of the esophagus and not through the wall of the esophagus which is easy to do since the whole wall is only 2 to 3 mm thick.
• Fig. 3 is a cross-sectional view above the top of the ring as seen with the gastroscope placed in the esophagus showing the top 3C of GARDTM ring 3A in upper view, sites 12 of injection right above the GARDTM ring 3A.
• the injections sites are at two levels, immediately above 12 the ring 3 A and 1 cm above 13 the ring 3A. Injecting two levels instead of one level is optional.
• the end 14 of the tubular part of the GARDTM is seen in perspective.
• Fig. 4 illustrates an injection balloon catheter 15 with guiding tubes 18 before inflation at introduction.
• Two guiding tubes 18 are shown on both sides of the central catheter 17 for the central guide- wire 17 A and the air inflation for the balloon 17B.
• a third guiding tube is in the back, not shown since hidden by the central part of the catheter 17.
• the balloon 16 is not inflated in this view.
• the tubes 18 act as lumens for guiding tubes for botulinum toxin injection catheters.
• the balloon catheter is placed above and inside the GARDTM ring to guide botulinum toxin injection at the right depth and at even distances around the circumference of the esophagus.
• the injection catheter can be combined with the delivery or introduction device used to place the GARDTM in the esophagus through the mouth as the same balloon helps deploy the GARDTM ring 3A and insures proper placement of the injection tubes 18 needed for precise botulinum toxin injection in the esophageal wall (See Figures 8, 9 and 10) or two separate catheters can be used, the first one to introduce the GARDTM and the second one to inject the botulinum toxin.
• the balloon catheter is separate from the delivery or introduction device.
• This catheter is used after the GARDTM device has been placed in the esophagus.
• the catheter has a central lumen used to place the catheter over a central guide wire 17A placed first through the mouth and esophagus into the stomach with an endoscope.
• the balloon can be inflated to help deploy the GARDTM ring as shown in Fig 5A.
• the three arms of the balloon expander 22 will be lifted and will push up the distal end of the guiding tubes so that the injection catheter 19 placed in the guiding tube 18 can be pushed until the injection catheter makes contact with the wall of the esophagus 10 at a proper angle.
• the needle is then deployed and pierces the wall of the esophagus at the depth needed to reach the muscular layer of the esophagus.
• Fig. 5 A illustrates an injection balloon catheter 15 with inflated balloon 16 and guiding tubes 18 for injection.
• the injection catheter 19 includes needle 20 shown in the wall of the esophagus 1.
• a syringe 21 with botulinum toxin is shown ready for injection in the wall of the esophagus 1.
• Fig. 5B illustrates a balloon expander 22 with 3 arms spread.
• a triangular balloon 23 not yet inflated in Fig. 6 is inflated in Fig. 7 and pushes up the arm 22 of the balloon expander and the end of the guiding tube 18 at a proper angle so that the injection catheter 19 will reach the esophageal wall and the needle 20 will penetrate the esophageal wall at the desired depth reaching the esophageal wall of the esophagus.
• FIG. 8A illustrates a combination of the delivery catheter or GARDTM Introducer with the Botulinum toxin injection catheter wherein the GARDTM ring 3A is folded during insertion and held in place with a suture 25A around the ring 3A to keep the ring folded and a knot 24A and thread 25A that then penetrates in the central catheter 17 through port 17C which is the proximal exit of the thread 25A.
• the GARDTM tube 4 is also folded and held in place with a suture (not shown in the bottom of the drawing) and a knot (not shown in the bottom) that will be pulled out when pulling on 25B at the top of the drawing to the left.
• the tubular part 4 of the GARDTM can be either smooth or lamellar as shown in Figs. 1A-1B.
• Fig. 1A shows a smooth tubular part 4A of the GARD device.
• Fig. IB shows a lamellar tubular part 4B of the GARDTM device.
• Fig 8A is a combination of the delivery catheter or GARDTM Introducer with the Botulinum toxin injection catheter.
• the knot 24A used is a special knot known as the “draw hitch” that can be released simply by pulling at one end, even at a distance and the knot will be released and the thread can be pulled out very easily. The security has to be pulled out first before the 2 other knots can be released.
• Fig 8B is a transverse cross-sectional view of the central catheter 17, showing a lumen for the central guide wire 17A, lumen 17B for inflation of balloon and 17D is empty for possible future use, lumens for threads 25A and 25B and security thread 25C for the deployment threads of the GARDTM ring and tube. Guiding tubes 18 for the injection catheter are illustrated.
• Fig. 8C is a variant of Fig 8B with a fourth “bean shape” hole, 2 holes 17C and 17E are used for the threads 25A and 25B used to deploy the ring and tube of the GARDTM device and a security thread 25C passing through 17E.
• 17B is for inflation/deflation of the oval balloon and 17D is a spare lumen that can be used if needed for inflation of the triangular balloon, see Fig 11 , when and if 2 balloons are used.
• Fig. 9 shows threads 25A, B, and C pulled out to release the GARDTM and air injection 17B to inflate the balloon, shown inflated.
• the three knots are released, first the security knot 25C then 25 A and 25B, and the GARDTM ring expands as well as the tube.
• the balloon is then inflated 17B to make sure that the GARDTM ring expands properly and reaches the wall of the esophagus.
• a gastroscope or fluoroscopy or both can be used optionally to check that the GARDTM ring is properly expanded.
• FIG. 10 illustrates threads 25 A, B, and C completely pulled out of the catheter with balloon 16 inflated and injection catheter 19 in guiding tube 18 with needle 20 drawn to penetrate the esophageal wall muscular layer 9.
• Syringe 26 pumps toxin so it is injected through needle 20.
• This operation is repeated three times in each of the 3 guiding tubes then the catheter can be rotated and the same operation can be repeated once or twice depending on the diameter of the esophagus so that 6 infections (for smaller diameter GARDsTM with a small circumference of the ring) up to 9 injections of botulinum toxin (for larger diameter GARDs with a larger circumference of the ring) can be performed at the exact depth in the muscular layer of the esophagus and at equidistance around the circumference of the esophagus above the deployed GARDTM ring.
• Fig 11 illustrates a combination of a top small triangular, or conical balloon 23 used to spread the arms of the arm expander 22 and the guiding tube 18 and a bottom oval balloon 16 to help deploy the ring of the GARDTM.
• a stopper 30 in the middle of both balloons separates both balloon and prevents the folded ring (not shown folded) to move upwards when the threads are pulled out (see Fig 10) during deployment of the ring 3A.
• the distance between the injection needle and the upper limit of the ring of the GARDTM should be in the order of 1 cm to 2 cm, preferably 1 cm so the botulinum toxin acts at its best to prevent migration of the GARDTM ring.
• the oval balloon can be deflated once the GARDTM ring is deployed and the device pushed down a few centimeters so that the small triangular or rather conical balloon is right above the ring 3 A (not shown) and the injection of botulinum are even closer to the top part of the GARDTM ring.
• FIG. 12A is a side perspective view of an alternative GARD Introducer with a Botulinum toxin injection catheter and with a guide wire (see Figs. 12B and 12C) according to the presently disclosed technology.
• the catheter 17 of the present embodiment can include a plurality of, and optionally three, vertically spaced-apart and vertically and/or linearly aligned openings 30A, 30B, 30C extending through a sidewall thereof in a body of the catheter 17.
• the openings 30A, 30B, 30C are optionally aligned to be parallel to the longitudinal axis L of the catheter 17 and each other.
• Each opening 30A, 30B, 30C being sized, shaped, and/or configured to allow a thread to pass therethrough.
• an upper end of the catheter 17 can optionally include a proximal opening 36 leading to a central passageway of the catheter 17.
• the sidewall can surround the central passageway.
• the proximal opening 36 and the central passageway are optionally in vertical alignment with the longitudinal axis L of the catheter 17.
• the guide wire 17A can extend through the proximal opening 36 and the central passageway and can run parallel with the longitudinal axis of the catheter 17 when the guide wire 17A extends through the catheter 17.
• the catheter 17 can include a port 34 offset from or extending at an angle (e.g., at approximately 20-30 degrees) from the longitudinal axis L of the catheter 17 and spaced-apart from the opening 36.
• the port 34 can surround a relatively short passageway that leads to the central passageway.
• the port 34 can be sized, shaped, and/or configured to receive each of at least three threads 31A, 31B, 31C therein.
• each of the threads 31A, 31B, 31C can enter into the catheter 17 at the port 34, and exit the catheter 17 at one of the openings 30A, 30B, 30C.
• the first thread 31 A can exit the catheter 17 at the lowest most opening 30A
• the second thread 31B can exit the catheter 17 at the middle opening 30B
• the third thread can exit the catheter 17 at the upper most opening 30C.
• the first thread 31 A can optionally be a security thread or a back-up thread, and can be omitted if desired.
• the second thread 3 IB can be configured for holding the ring 3A.
• the third thread 31C can be configured for holding the tube 4.
• the threads are not limited to being formed of a particular material, or being a particular size.
• the threads can be formed of the same material, or different threads can be formed of different material.
• the presently disclosed technology can include at least two draw string knots 31D, 31E.
• a free or straight end of the first thread 31A can extend through a first one of the draw string knots 31 D, which can be attached to the ring 3 A.
• a second one of the draw string knots 31E can be attached to the tube 4.
• the proximal end of the catheter is divided, such that the guide wire 17A extends generally or exactly straight along the longitudinal axis L and the threads 31 A, 3 IB, 31C extend out on one side of the catheter.
• the upper part of the catheter shown in Fig. 12A is the proximal part of the catheter that is out of the body, which the endoscopist and/or his/her assistant(s) have access to work on.
• Figs. 1A and IB show the position of the GARDTM device in the lower esophagus 1.
• a first thread 31 A can be pulled out completely from the catheter 17.
• a second thread 31B holding the top 3C of the ring 3A with the helical spring 3B within a silicon ring will be freed by pulling on it.
• the ring 3 A will deploy to reach the wall of the esophagus.
• the tube 4B is freed by pulling on a third thread 31C.
• the present embodiment does not employ or require a balloon or any guiding tubes (e.g., compare Figs. 8B and 8C to Figs. 12B and 12C).
• the guide wire 17A is first placed at the endoscopy with the gastroscope through a standard working channel of the gastroscope. Then, the gastroscope is removed and the delivery catheter is placed on the guide wire into the esophagus. The gastroscope is replaced in the esophagus to determine where to place the ring 3A and pull on the plurality of threads to deploy the ring 3A and place the ring in in the desired position in the esophagus.
• Fig. 12B is a cross-sectional view of the central catheter of Fig. 12A.
• Fig. 12C is an alternative cross-sectional view of the central catheter of Fig. 12A.
• FIG. 13 is a side perspective view of the alternative GARD Introducer of Fig. 12A with threads untied.
• FIG. 14 is a side perspective view of the alternative GARDTM Introducer of Fig. 12A without the threads and/or after the thread have been pulled out or removed from the catheter 17.
• the tubular part 4 of the GARDTM can be either smooth or lamellar as shown in Figs. 1 A-1B.
• Fig. 1A shows a smooth tubular part 4A of the GARDTM device.
• Fig. 2A shows a lamellar tubular part 4B of the GARD device.
• Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis of the muscles. Botulinum toxin also paralyzes smooth muscles as well as striated muscles.
• Botulinum toxin particularly type A
• BoTox® is already widely used in medicine and sold as BoTox® by Allergan
• Dysport® by Ipsen Pharma
• Xeomin® by Merz Pharmaceuticals for treatment of muscular blockage in the eye for blepharospasm, bladder hyperactivity, cervical dystonia, chronic migraine, focal limb spasticity, and for face wrinkles.
• botulinum toxin can be injected in very small volumes, in the order of 0.1 ml to 0.4 ml, which is desirable for injection in a very narrow area of esophageal muscle about 1 mm to 2 mm thick (about 0.04 to 0.08 inches).
• an injection device incorporated or clipped on the delivery system used to place the GARD in the esophagus or an independent injection device from the catheter used to place the GARD in the esophagus is used to inject the botulinum toxin around the inner circumference of the esophagus at a precise depth in the wall of the esophagus.
• the injection device can include a balloon that is inflated when in position with three “guiding” tubes placed at 120 degrees of each other around the 360 degree circumference. Once inflated, when the balloon is in contact with the wall of the esophagus, the exact angle of the guiding tube and the wall of the esophagus can be determined precisely as the end portion of the guiding tubes is glued to the top part of an hexagonal shaped balloon or better placed on an “balloon expander” made of a ring and 3 “legs” that are spread by the inflated balloon.
• An injection catheter obtained commercially (Olympus NeedlemasterTM needles, Boston Scientific InterjectTM , Cook Medical AcuJectTM) is passed through the guiding tubes until the catheter reaches the esophageal wall. Since the angle between the catheter with the needle and the wall of the esophagus depends on the diameter of the esophagus that conditions the volume of air used to inflate the balloon and the diameter of the ring of the GARDTM device used for a given patient, the exact depth of injection can be calculated for each diameter of GARDTM ring and the appropriate catheter with needle length, normally between 3 mm and 6 mm long can be chosen in advance so as to inject at a 2 mm depth in the muscular layer of the esophagus in order to inject the botulinum toxin blindly through the esophageal wall into the muscular layer of the esophagus, avoiding injections in the mucosa or submucosa that is too proximally which can cause esophageal muco
• the device does not include a balloon.
• an endoscopic injection needle is passed through the endoscope.
• the needle is used for 4-12 injections.
• an injection is made right above the ring of the GARDTM.
• Botulinum toxin injection into the gastroesophageal junction of the esophagus is used for more than 20 years to treat patients who have achalasia and non-cardiac chest pain with non-reflux, nonachalasia spastic esophageal motor disorders and studies have demonstrated efficacy in relieving pain see “Botulinum toxin for achalasia” by Pasricha et al in the Lancet 341 :244-245, 1993 and “Treatment of chest pain in patients with noncardiac, nonreflux, nonachalasia spastic esophageal motor disorders using botulinum toxin injection into the gastroesophageal junction by Larry S Miller et al.
• Botulinum toxin is a potential toxic compound
• the use of an injection guide to help the endoscopist inject the botulinum toxin at the selected, right location and at a selected depth to reach the muscular layer of the esophagus mitigates the potential risks of botulinum toxin injections.
• botulinum toxin injection will last for up to one year which is more than sufficient for the first generation DM-GARDTM that will be used up to 4 weeks then replaced after 1 month by the Therapeutic-GARDTM and Obesity-GARDTM that will include features in addition to the botulinum toxin to help keep the devices in place for longer periods of time.
• EP 2729162 Bl assigned to Allergan, Inc. describes treating two conditions, Diffuse Esophageal Spasm (DES) and “Nutcracker esophagus,” with Botox A injections in the esophagus.
• the presently disclosed technology can include injecting Botulinum toxin A in the muscular layer of the body of the esophagus right above the ring of the GARDTM, not all along the length of the esophagus as needed for DES and Nutcracker which the procedure described in the Allergan patent. Allergan’s patent does not describe using Botox A to prevent migration of a medical device like the GARD.
• Botulinum toxin A will not be used for injections in the esogastric junction as used in achalasia but exclusively in association with medical devices to diagnose and treat GERD, LPR and obesity above the esogastric junction in the lower third of the esophagus and preferably about 3 cm to 5 cm above the Z line which is the limit of the gastric mucosa and the esophageal mucosa at the esogastric junction.
• the balloon element of the system has two functions, first to help deploy the GARDTM ring and stabilize the guiding tubes thanks to the balloon expander before botulinum toxin injection and second to enable exact placement of the delivery catheter with the balloon in the center of the esophagus which in turn enables appropriate placement of the guiding tubes in the correct direction and right angle to control depth of botulinum toxin injection precisely into the muscular layer of the esophagus that is 2 mm deep while operating at a distance of about 1 meter (or about 3 feet) away.
• the injection is made about 1 cm above the upper ring of the GARDTM with a purging volume in the catheter of approximately one milliliter and a controlled length of the needle of 3 mm to 6 mm when taken out of the protection sheath at endoscopy using a 21 to 25 gauge needle, preferably a 23 gauge needle, that will reach both smooth muscle layers of the esophagus to avoid injecting the toxin at another location either too proximally in the mucosa or submucosa of the esophagus or too distally beyond the esophagus as the botulinum toxin can be very toxic even at very low dose.
• the system does not include any guiding tubes.
• An endoscopic injection needle is passed through the endoscope.
• the presently disclosed technology can employ an inflatable calibration balloon 38.
• the calibration balloon 38 can have a diameter in an inflated configuration of about 3 mm.
• the balloon 38 can be employed to calibrate the esophagus 1 of the patient and/or expand the ring of the GARDTM when it does not expand as desired.
• the deflated calibration balloon 38 when a healthcare professional carefully calibrates the esophagus 1 by placing the deflated calibration balloon 38 in the esophagus 1 at the location of the GARDTM implantation and inflates the calibration balloon 38 with air (optionally via syringe 21) until it is impossible to inflate the calibration balloon 38 more and the calibration balloon 38 is completely distending the esophagus 1 as observed with the gastroscope, the volume of air used for the distension is noted. Then, the calibration balloon 38 can be deflated and taken out of esophagus 1 of the patient. The calibration balloon 38 can then be reinflated outside the patient with the same volume of air used to inflate the calibration balloon 38 in the esophagus 1.
• the diameter of the calibration balloon 38 can then be measured by a calibration card or calibration block 40 (see Fig 16), which in one optional embodiment measures two centimeters high with ten holes measuring precisely between 21 mm and 30 mm in diameter.
• the calibration balloon 38 can then be reinflated and the exact diameter is measured. If the inflated calibration balloon 38 is between two holes sizes, the larger hole size is measured.
• the healthcare professional can use the calibration balloon 38 in the stent and inflate the calibration balloon 38 to help distend the folded ring against the wall of the esophagus 1 or do maneuvers with the tip of the endoscope to push the ring of the DM 1 against the wall of the esophagus 1.
• the ring does not always distend completely and there can often be the help of the host’s body heat that makes the ring softer and helps distend the ring against the wall of the esophagus 1, the DM1 tends to fall into the stomach most of the time before 4 months of implantation.
• the GARD device can be placed in the esophagus with a top nitinol helicoidial spring ring folded on the delivery catheter and held in position without a balloon.
• the catheter can be placed in the esophagus with the help of a guide wire catheter held in position for introduction, and the threads can be pulled out and the ring GARD can be deployed spontaneously due to the helicoidal spring in the ring.
• a manometer 39 or other pressure measurement device can be employed to indicate to the user how much air was injected into the calibration balloon 38 when the balloon 38 is in the esophagus. The same procedure can be repeated once the calibration balloon 38 is outside of the body or esophagus to determine the diameter of the ring of the esophagus to be chosen and therefore the size of the GARD device.
• the manometer 39 can be attached in any of a variety of ways, such as with a luer-lock connection.
• a total volume of 1 ml of solvent will be used in a 100-Unit vial of Botox or Xeomin so that each 0.1 ml of solution contains 10 Units of botulinum toxin.
• the catheter is purged with the solution outside the body of the patient, there should be at least 1 ml of the botulinum toxin ready for injection in the syringe after purging the catheter with the botulinum solution.
• 0.1 ml to 0.15 ml corresponding to 10U to 15U should be injected at 6 to 9 sites of equal distance around the circumference of the esophagus for a total of about 90 units of botulinum toxin.
• a catheter with 3 injection tubes will help guide the injection catheter at a pre-determined angle of penetration of the esophageal wall depending on the inflation of the balloon, which will help determine the depth of injection.
• fluoroscopy can help guarantee injection in the esophageal wall and in the proper muscular layer of the esophageal wall.
• the preferred botulinum toxin for injection used is Xeomin® by Merz where 1 ml of NaCl 0.9% is used to reconstitute the solution then injected in an Olympus endoscopic injection catheter.
• other brands of botulinum toxins can be used as well as other catheter and dosages.
• the system does not include a balloon.
• An endoscopic injection needle is passed through the endoscope.
• the needle is used for a number of injections, such as 4-12 injections.
• An injection is made right above the ring of the GARDTM, for example about 1 cm above.
• the needle is used for 4-12 injections.
• an injection is made right above the ring of the GARD.
• a system comprising a catheter device configured to orient an injection and configured to allow injection of botulinum toxin at a selected depth in the esophagus of a patient to reach the muscular layer around the circumference of the esophagus to block peristalsis, the system not including a balloon.
• IE The system of embodiment 1A, wherein the catheter device includes an opening spaced apart from a port at a proximal end thereof and a plurality of spaced-apart openings in a body thereof.
• threads are configured to enter the catheter at the port and exit the catheter at one of the plurality of spaced-apart openings, each thread being configured to be removably attached to the gastroesophageal anti-reflux device.
• 1G The system of embodiment 1A, wherein the catheter includes three vertically spacedapart openings extending through a sidewall thereof, each opening being configured to allow a thread to pass therethrough.

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