Method and instruments for treating GERD

• US 8,567,409 B2
• Filed: 01/29/2009
• Issued: 10/29/2013
• Est. Priority Date: 01/29/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Milux Holding SA
• Inventors: Forsell, Peter
• Primary Examiner(s): Matthews, William H
• Application Number:
  US12/864,982
• Publication Number:
  US 20100331615A1
• Time in Patent Office: 1,734 Days
• Field of Search: 623 2364- 2365, 606/191, 600/37, 128/898
• US Class Current: 128/898
• 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 surgical abdominal methods of treating a reflux disease in a patient by implanting a movement restriction device that, when implanted in a patient, restricts the movement of the stomach notch in relation to the diaphragm muscle preventing the cardia to slide up through the diaphragm hiatus opening. Also disclosed is a laparoscopic instrument for providing a movement restriction device to be invaginated in the stomach fundus wall of a human patient to treat reflux disease.

Claims

1. A method of treating a reflux disease in a patient by implanting a movement restriction device that, when implanted in a patient, restricts the movement of the stomach notch in relation to the diaphragm muscle, thereby preventing the cardia from sliding up through the diaphragm hiatus opening, the method comprising the steps of:

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body;

using the needle or tube like instrument to fill the patient'"'"'s abdomen with gas;

placing at least two laparoscopic trocars in the patient'"'"'s body;

inserting a camera through one of the laparoscopic trocars into the patient'"'"'s abdomen, inserting at least one dissecting tool through one of said at least two laparoscopic trocars;

dissecting an area of the stomach;

introducing the movement restriction device into the abdominal cavity;

placing the movement restriction device on the outside of the stomach fundus wall;

creating a pouch in the stomach fundus wall for the movement restriction device; and

in-vaginating the movement restriction device in the pouch by providing sutures or staples to the stomach fundus wall, thereby preventing the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the pressure support from the patient'"'"'s abdomen that supports the patient'"'"'s cardia sphincter muscle.

2. The method according to claim 1, further comprising affixing the device to the stomach fundus wall by providing sutures or staples.

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

4. The method according to claim 1, further comprising affixing the stomach fundus wall to the patient'"'"'s diaphragm muscle or associated muscles.

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

and operating said apparatus to regulate the movement restriction device.

6. The method according to claim 5, wherein the movement restriction device comprises a filling body, wherein regulation of the movement restriction device includes changing the volume of the filling body when implanted.

7. The method according to claim 6, comprising providing an injection type syringe comprising a fluid for injection into a the filling body;

and

injecting volume of fluid into the filling body.

8. The method according to claim 1, wherein the step of crating a pouch and invaginating the movement restriction device in the pouch, comprises fully enclosing the device in the pouch.

9. The method according to claim 1 wherein the step of creating a pouch and invaginating the movement restriction device in the pouch comprises invaginating the movement restriction device such that the movement restriction device is not fully enclosed in the pouch, wherein the pouch is at least partly open.

10. The method according to claim 9, wherein the step of creating a pouch and invaginating the movement restriction device in the pouch comprises creating a pouch that exhibits only one opening.

11. The method according to claim 9, wherein the steps of creating a pouch and invaginating the movement restriction device in the pouch comprises creating a pouch that exhibits two openings and extends non-circumferentially around the stomach.

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

13. The method of treating reflux disease according to claim 1, wherein the step of in-vaginating the movement restriction device in the pouch, comprises:

introducing an injecting member comprising an injectable filling material; and

injecting the filling material into the pouch, thereby creating a filling body that fills a volume in the created pouch, thereby preventing the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the pressure support from the patient'"'"'s abdomen that supports the patient'"'"'s cardia sphincter muscle.

14. A method of treating a reflux disease in a patient by implanting a movement restriction device that, when implanted in a patient, restricts the movement of the stomach notch in relation to the diaphragm muscle preventing the cardia to slide up through the diaphragm hiatus opening, the method comprising the steps of:

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body;

using the needle or tube like instrument to fill the patient'"'"'s abdomen with gas;

placing at least two laparoscopic trocars in the patient'"'"'s body;

inserting a camera through one of the laparoscopic trocars into the patient'"'"'s abdomen;

inserting at least one dissecting tool through one of said at least two laparoscopic trocars;

dissecting an area of the stomach;

creating a hole in the stomach;

introducing the movement restriction a device into the abdominal cavity;

introducing the movement restriction device through the hole in the stomach and into the stomach;

placing the device on the inside of the stomach fundus wall;

creating a pouch on the outside of the stomach cavity for the device placed on the inside of the stomach fundus wall, and

in-vaginating the movement restriction device in the pouch by providing sutures or staples to the stomach fundus wall, preventing the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax, so as to maintain the supporting pressure from the patient'"'"'s abdomen that supports the patient'"'"'s cardia sphincter muscle.

15. The method according to claim 14, further comprising affixing the movement restriction device to the stomach fundus wall by providing sutures or staples.

16. The method according to claim 14, further comprising affixing the stomach fundus wall to the lower part of the patient'"'"'s esophagus by providing sutures or staples.

17. The method according to claim 14, further comprising affixing the stomach fundus wall to the patient'"'"'s diaphragm muscle or associated muscles.

18. The method according to claim 14, further comprising providing an apparatus for regulating the movement restriction device from the outside of the patient'"'"'s body;

and operating said apparatus to regulate the movement restriction device.

19. The method according to claim 18, wherein the movement restriction device comprises a filling body, wherein regulation of the movement restriction device includes changing the volume of the filling body when implanted.

20. The method according to claim 19, comprising providing an injection type syringe comprising a fluid for injection into the filling body;

and

injecting volume of fluid into the filling body.

21. The method according to claim 14, wherein the step of creating a pouch and invaginating the movement restriction device in the pouch, comprising enclosing the device in the pouch.