Methods and instruments for treating GERD and hiatal hernia

• US 8,992,629 B2
• Filed: 01/29/2009
• Issued: 03/31/2015
• Est. Priority Date: 01/29/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/864,843
• Publication Number:
  US 20100312356A1
• Time in Patent Office: 2,252 Days
• Field of Search: 623 2364- 237, 606/139, 606/151, 606/191, 606/153, 128/898
• US Class Current: 623/23.65
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00827 : Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/308 : with suction cups
• CPC Class Codes: A61F 2/04 : Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 : Stomach, intestines
• CPC Class Codes: A61F 2005/0016 : comprising measuring means
• CPC Class Codes: A61F 2005/002 : for sensing mechanical parameters
• CPC Class Codes: A61F 2005/0023 : for sensing chemical parameters
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 : adjustable
• CPC Class Codes: A61F 5/0003 : Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0013 : Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0026 : Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/003 : inflatable
• CPC Class Codes: A61F 5/0033 : with more than one chamber
• CPC Class Codes: A61F 5/0036 : Intragastrical devices
• CPC Class Codes: A61F 5/004 : remotely adjustable
• CPC Class Codes: A61F 5/0043 : using injection ports
• CPC Class Codes: A61F 5/0046 : with wireless means
• CPC Class Codes: A61F 5/005 : Gastric bands
• CPC Class Codes: A61F 5/0063 : wrapping the stomach
• CPC Class Codes: A61F 5/0069 : in the wall of the stomach
• CPC Class Codes: A61F 5/0073 : in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 : Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0083 : Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The invention relates to an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an movement restriction device that, when implanted in a patient, fills a volume in the patient'"'"'s abdomen that is close to and at least partially above the patient'"'"'s cardia when the patient is in a standing position. The invention further relates to a method of restoring the location of the cardia in a patient suffering from a reflux disease and to an instrument suitable to use with intraluminar method and/or restoration method. Also disclosed are instruments treating a patient suffering hiatal hernia and providing a movement restriction device to be invaginated in the stomach fundus wall.

Claims

1. An intraluminar method of treating a reflux disease in a patient by implanting a device comprising an implantable movement restriction device that is adapted to restrict the movement of the patient'"'"'s stomach notch in relation to the patient'"'"'s diaphragm muscle, preventing the patient'"'"'s cardia from sliding up through the patient'"'"'s diaphragm hiatus opening, when implanted in the patient, the method comprising the steps of:

introducing a gastroscope in the patient'"'"'s oesophagus and into the patient'"'"'s stomach;

introducing an instrument in the oesophagus and into the stomach of the patient, the instrument being integrated in the gastroscope or being separate from the gastroscope;

providing, by means of the instrument, a pouch from the patient'"'"'s stomach fundus wall for accommodating the device;

invaginating the device in the pouch with sutures or staples to the stomach fundus wall, to thereby prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the supporting pressure against the patient'"'"'s cardia sphincter muscle exerted from the patient'"'"'s abdomen;

creating, by means of the instrument a pouch of a portion of the stomach fundus wall;

introducing the device into the pouch;

invaginating the device with sutures or staples to the stomach fundus wall; and

injecting a filling fluid into the device so it obtains its filling volume.

10. The method according to claim 1, further comprising providing an apparatus for regulating the reflux treatment device from the outside of the patient'"'"'s body;

and operating said apparatus to regulate the reflux treatment device.

11. The method according to claim 10, wherein regulation of the reflux treatment device includes changing the volume of the filling body when implanted.

12. The method according to claim 11, comprising providing an injection type syringe comprising a fluid for injection into an implanted filling body;

and injecting volume of fluid into filling body.

13. The method according to claim 1, comprising admitting the pouch being at least partly open.

14. The method according to claim 1, wherein the volume of the pouch is more than 15 milliliters.

16. The method according to claim 1, further comprising providing using an apparatus to regulate the reflux treatment device from the outside of the patient'"'"'s body;

and operating the apparatus to regulate the reflux treatment device.

18. The method according to claim 10, wherein the volume of the pouch is more than 15 milliliters.

19. The method according to claim 1, comprising at least one of:

inflating the stomach with gas, and generating vacuum by the instrument when providing the pouch from the stomach fundus wall.

21. The method according to claim 10, comprising at least one of:

inflating the stomach with gas, and generating vacuum by the instrument when providing the pouch from the stomach fundus wall.

22. The method according to claim 1, further comprising the steps of:

restoring the location of the cardia and the fundus in a patient suffering from a reflux disease;

introducing an elongated instrument having at least one flexible part into oesophagus of a patient;

activating a holding device by the elongated instrument, said activated holding device having larger cross-sectional area than the elongated instrument;

holding the distal esophagus or stomach with said holding device;

moving and pushing the elongated instrument in a distal direction so the cardia and the stomach wall, or part of fundus, incorrectly located above diaphragm, or its associated muscles, slide back in a position below the diaphragm, or its associated muscles.

24. The method according to claim 10, further comprising the steps of:

restoring the location of the cardia and the fundus in a patient suffering from a reflux disease;

introducing an elongated instrument having at least one flexible part into the oesophagus of the patient;

activating a holding device by the elongated instrument, the activated holding device having a larger cross-sectional area than the elongated instrument;

holding the distal esophagus or stomach with the holding device;

moving and pushing the elongated instrument in a distal direction so the cardia and the stomach wall, or part of fundus, incorrectly located above the diaphragm, or its associated muscles, slide back in a position below the diaphragm, or its associated muscles.

25. The method according to claim 1, further comprising affixing the stomach fundus wall to the lower part of the patient'"'"'s oesophagus by providing sutures or staples.

26. The method according to claim 10, further comprising affixing the stomach fundus wall to the lower part of the patient'"'"'s oesophagus by providing sutures or staples.

2. An intraluminar method of treating a reflux disease in a patient by implanting a device comprising an implantable movement restriction device that is adapted to restrict the movement of the patient'"'"'s stomach notch in relation to the patient'"'"'s diaphragm muscle preventing the patient'"'"'s cardia from sliding up through the patient'"'"'s diaphragm hiatus opening, when implanted in the patient, the method comprising the steps of:

introducing a gastroscope in the patient'"'"'s oesophagus and into the patient'"'"'s stomach;

introducing an instrument in the oesophagus and into the stomach of the patient, the instrument being integrated in the gastroscope or separate from the gastroscope;

providing, by means of the of instrument, a pouch from the patient'"'"'s stomach fundus wall for accommodating the device;

invaginating the device in the pouch with sutures or staples to the stomach fundus wall, to thereby prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the supporting pressure against the patient'"'"'s cardia sphincter muscle exerted from the patient'"'"'s abdomen,

creating, by means of the instrument, a pouch of a portion of the stomach fundus wall;

introducing the device into the pouch;

invaginating the device with sutures or staples to the stomach fundus; and

inflating the device to its filling volume.

3. An intraluminar method of treating a reflux disease in a patient by implanting a device comprising an implantable movement restriction device that is adapted to restrict the movement of the patient'"'"'s stomach notch in relation to the patient'"'"'s diaphragm muscle preventing the patient'"'"'s cardia from sliding up through the patient'"'"'s diaphragm hiatus opening, when implanted in the patient, the method comprising the steps of:

introducing a gastroscope in the patient'"'"'s oesophagus and into the stomach of the patient;

introducing an instrument in the oesophagus and into the patient'"'"'s stomach, the instrument being integrated in the gastroscope or separate from the gastroscope;

providing, by means of the instrument, a pouch from the patient'"'"'s stomach fundus wall for accommodating the device;

invaginating the device in the pouch with sutures or staples to the stomach fundus wall, to thereby prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the supporting pressure against the patient'"'"'s cardia sphincter muscle exerted from the patient'"'"'s abdomen;

creating a hole in the stomach fundus wall;

introducing the device into the stomach;

moving the device through the hole and placing it on the outside of the stomach fundus wall;

creating, by means of the instrument, a pouch of a portion of the stomach fundus wall on the inside of the stomach cavity, with the device placed against the outside of the stomach fundus wall;

invaginating the device in the pouch with sutures or staples to the stomach fundus wall; and

sealing the hole with sutures or staples.

4. An intraluminar method of treating a reflux disease in a patient by implanting a device comprising an implantable movement restriction device that is adapted to restrict the movement of the patient'"'"'s stomach notch in relation to the patient'"'"'s diaphragm muscle preventing the patient'"'"'s cardia from sliding up through the patient'"'"'s diaphragm hiatus opening, when implanted in the patient, the method comprising the steps of:

introducing a gastroscope in the oesophagus and into the patient'"'"'s stomach;

introducing an instrument in the oesophagus and into the stomach of the patient, the instrument being integrated gastroscope or separate from the gastroscope;

providing, by means of the instrument, a pouch from the stomach fundus wall for accommodating the device;

invaginating the device in the pouch with sutures or staples to the stomach fundus wall, to thereby prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the supporting pressure against the patient'"'"'s cardia sphincter muscle exerted from the patient'"'"'s abdomen;

creating a hole in the stomach fundus wall;

creating, by means of said instrument, a pouch of a portion of the stomach fundus wall on the inside of the stomach cavity;

introducing the device into the stomach;

moving the device through the hole and placing it on the outside of the stomach fundus wall;

introducing the device into the pouch;

invaginating the device with sutures or stables to the stomach fundus wall; and

sealing the hole with sutures or staples.

5. The method according to claim 4, comprising inflating the device to its filling volume.

6. The method according claim 5, comprising injecting a filling fluid into the device so it obtains its filling volume.

7. The method according to claim 4, further comprising affixing the device to the stomach fundus wall by providing sutures or staples.

8. The method according to claim 4, further comprising affixing the stomach fundus wall to the lower part of the patient'"'"'s oesophagus by providing sutures or staples.

9. The method according to claim 4, further comprising affixing the stomach fundus wall to the patient'"'"'s diaphragm muscle or associated muscles.

15. The method according to claim 4, further comprising providing an apparatus for regulating the reflux treatment device from the outside of the patient'"'"'s body;

and operating said apparatus to regulate the reflux treatment device.

17. The method according to claim 4, wherein the volume of the pouch is more than 15 milliliters.

20. The method according to claim 4, comprising at least one of:

inflating the stomach with gas, and generating vacuum by the instrument when providing the pouch from the stomach fundus wall.

23. The method according to claim 4, further comprising the steps of:

restoring the location of the cardia and the fundus in a patient suffering from a reflux disease;

introducing an elongated instrument having at least one flexible part into the oesophagus of the patient;

activating a holding device by the elongated instrument, the activated holding device having larger cross-sectional area than the elongated instrument;

holding the distal esophagus or stomach with the holding device;

moving and pushing the elongated instrument in a distal direction so the cardia and the stomach wall, or part of fundus, incorrectly located above diaphragm, or its associated muscles, slide back in a position below the diaphragm, or its associated muscles.

27. The method according to claim 4, further comprising at least one of the following method steps:

introducing the device into the stomach by means of the instrument; and

introducing the device into the pouch by means of the instrument.