OBESITY TREATMENT

• US 20120041463A1
• Filed: 01/29/2010
• Published: 02/16/2012
• Est. Priority Date: 01/29/2009
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Milux Holding SA
• Inventors: Forsell, Peter
• Granted Patent: US 10,925,764 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0043 using injection ports
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• 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
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A volume filling device for treatment of obesity is placed outside the stomach wall of the patient to reduce the inner volume of the stomach, thereby affecting the patient'"'"'s appetite. By providing the volume filling device outside the stomach wall, contact with stomach acids is avoided, thereby increasing the life of the device.

Claims

1. An apparatus for treating obesity of an obese patient having a stomach with a food cavity, the apparatus comprising:

at least one volume filling device adapted to be at least substantially invaginated by a stomach wall portion of the patient by sutures or staplers from the stomach wall to the stomach wall from the outside of the stomach without penetrating the mucosa, and

wherein the at least one volume filling device is adapted to be placed on the outside of the stomach wall with the outer surface of the at least one volume filling device resting against the outside of the stomach wall, such that the volume of the food cavity is reduced in size by a volume substantially exceeding the volume of the at least one volume filling device.

2. The apparatus according to claim 1, comprising two or more volume filling devices, wherein the outer surface of at least one volume filling device rests against the outside of the stomach wall via the outer surface of at least another volume filling device.

3. The apparatus according to claim 1, wherein at least one of the volume filling devices has a surface with a rugged texture or a flat surface.

4. The apparatus according to claim 1, wherein at least one of the volume filling devices has one of the following shapes:

polyhedron, tetrahedron, hexahedron, octa hedron, dodecahedron, icosahedrons, and spherical.

5. The apparatus according to claim 1, comprising a friction enhancing material.

6. The apparatus according to claim 5, wherein the friction enhancing material is any of the following:

a glue and an adhesive.

7. The apparatus according to claim 1, comprising a friction reducing material on the outer surface of the volume filling devices.

8. The apparatus according to claim 7, wherein the friction reducing material is a fluid reducing the friction between adjacent volume filling devices.

9. The apparatus according to claim 1, comprising a combined volume filling device, said combined volume filling device comprising two or more volume filling devices.

10. The apparatus according to claim 9, wherein the combined volume filling device further comprises a volume filling device receptacle for receiving and enclosing two or more volume filling devices.

11. The apparatus according to claim 10, wherein the volume filling device receptacle comprises a friction reducing material on an inner surface thereof thereby reducing friction between said inner surface and said volume filling devices, when implanted.

12. The apparatus according to claim 10, wherein the expandable volume filling device receptacle is adapted to be filled with a fluid to allow mutual movement between adjacent volume filling devices so that the combined shape of the combined volume filling device adapts to stomach wall movements, when said combined volume filling device is invaginated in a stomach wall.

13. The apparatus according to claim 10, wherein at least a wall portion of said volume filling device receptacle is flexible, stretchable, expandable, or elastic.

14. The apparatus according to claim 8, wherein said fluid is isotonic or hypertonic.

15. The apparatus according to claim 1, wherein the volume filling devices are adapted to be directly or indirectly filled into the pouch formed by part of a stomach wall of a patient via a tubular instrument.

16. The apparatus according to claim 1, wherein the volume filling devices comprise a solidifying liquid.

18. The apparatus according to claim 1, wherein said plurality of volume filling devices are adapted to be interconnected after said volume filling devices have been inserted into a human or artificial pouch, or are adapted to be assembled to an implantable volume filling device.

20. The apparatus according to claim 1, wherein the volume filling devices are adapted to be inserted into a pouch formed by part of a stomach wall.

155. The method of using a device according to claim 1, wherein said method comprises one or more of the following operational method steps:

introducing said instrument into the throat,

passing down the esophagus,

placing an anvil or unit for delivery of fixating members in the esophagus between the cardia and the diaphragm level, for engaging in the fixation of the esophagus to the stomach tissue,

passing down the esophagus and additionally further down into the stomach,

filling the stomach with gas to expand the stomach,

sucking fluid from the stomach,

looking at a guiding vision when said instrument comprising a camera,

engaging the instrument with the stomach,

creating and suturing at least one pouch of the stomach wall,

filling said at least one pouch with a fluid and/or volume filling device or two or more volume filling devices,

deliver a plurality of volume filling devices into said pouch created in the stomach tissue through a tubular member,

passing through the stomach wall with said instrument,

passing through the stomach wall with said instrument for the placement of a volume filling device on the outside of the stomach wall,

passing through the stomach wall with said instrument for the placement of a tube allowing placement of a subcutaneous injection port,

placing an subcutaneous injection port,

suturing or stapling the stomach wall from the inside thereof to the esophagus,

suturing or stapling the stomach wall to stomach wall from the inside of the stomach,

engaging the instrument with the esophagus,

suturing or stapling one layer of stomach tissue to one layer of esophageal tissue,

suturing or stapling two layers of stomach tissue to one layer of esophageal tissue,

suturing or stapling three layers of stomach tissue to one layer of esophageal tissue,

suturing or stapling four layers of stomach tissue to one layer of esophageal tissue,

suturing or stapling one or more layers of stomach tissue to two or more positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in relation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a first point along a first esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance from said first esophagus surface length axis, radially in relation to said esophagus center axis,

delivering fixating members by a unit placed on said instrument,

penetrating at least one layer of stomach tissue and one layer of esophagus tissue with said fixating members,

placing said fixating members above the gastro-esophageal junction for creating a tunnel between the esophagus and stomach above said junction,

placing an esophagus part in the esophagus and a stomach part in the stomach,

placing the fixating member substantially between the stomach and esophagus part,

inserting said instrument into the main stomach cavity through the cardia and adapted to direct the instrument in cranial direction to reach a position of said unit above said junction,

allowing the tunnel a substantially unrestricted contraction and release of the cardia closing sphincter muscle placed in said junction, when such a tunnel has been created.

157. The method of using a device according to claim 1, wherein said method comprises one or more of the following laparoscopic operational method steps:

cutting the skin of a patient

introducing a tube through the abdominal wall,

filling a fluid or gas into the abdominal cavity,

introducing two or more trocars into the abdominal cavity,

introducing a camera into the abdominal cavity through one of the trocars,

introducing said instrument into the abdominal cavity through a trocar,

engaging the instrument with the stomach,

pulling down into the stomach wall for creating at least one pre-shaped pouch of the stomach wall,

clamping the stomach wall for creating at least one pre-shaped pouch of the stomach wall,

suturing or stapling at least one pouch in the stomach wall,

filling said at least one pouch with a fluid and/or a volume filling device or two or more volume filling devices,

deliver a plurality of volume filling devices into said pouch created in the stomach tissue through a tubular member,

passing through the stomach wall into the stomach with said instrument,

passing through the stomach wall with said instrument for the placement of a volume filling device on the inside of the stomach wall,

passing through the stomach wall with said instrument for suturing the stomach wall to the esophagus wall,

placing a volume filling device on the outside of the stomach wall,

invaginating said volume filling device in the stomach wall

placing a subcutaneous injection port,

suturing or stapling the stomach wall to stomach wall from the outside of the stomach,

suturing or stapling two layers of stomach wall to one or two layers of stomach wall,

suturing or stapling the stomach wall to stomach wall from the outside of the stomach without penetrating the mucosa,

engaging the instrument with the esophagus,

clamping the on both sides of the esophagus for fixating one layer of esophageal wall to stomach tissue,

clamping the on both sides of the esophagus and the stomach fundus wall for fixating one layer of esophageal wall to one or two layers of stomach tissue,

introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixating delivery member involving in the fixation of the esophagus to the stomach,

coordinating the position of the anvil member or a fixating delivery member inside the esophagus to said instrument clamping around the esophagus,

suturing or stapling one layer of stomach tissue to one layer of esophageal tissue,

suturing or stapling two layers of stomach tissue to one layer of esophageal tissue,

suturing or stapling three layers of stomach tissue to one layer of esophageal tissue,

suturing or stapling four layers of stomach tissue to one layer of esophageal tissue,

stapling using staplers of different stapling depths at different positions in a stapler row,

stapling stomach to esophagus with one first stapler depth and stapling stomach to stomach with a second smaller stapler depth,

stapling a pouch with stomach to stomach sutures in a stapler row, further comprising stapling the esophagus with staplers of a larger depth included as a part of said stapler row,

suturing or stapling one or more layers of stomach tissue to two or more positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in relation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a first point along a first esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance from said first esophagus surface length axis, radially in relation to said esophagus center axis,

delivering fixating members by a unit placed on said instrument,

penetrating at least one layer of stomach tissue and one layer of esophagus tissue with said fixating members,

placing said fixating members above the gastro-esophageal junction for creating a tunnel between the esophagus and stomach above said junction,

allowing the tunnel a substantially unrestricted contraction and release of the cardia closing sphincter muscle placed in said junction, when such a tunnel has been created,

placing an esophagus part in the esophagus and a stomach part in the stomach via an introduction into the stomach cavity,

placing the fixating member substantially between the stomach and esophagus part,

inserting said instrument into the main stomach cavity below said junction and adapted to direct the instrument in cranial direction to reach a position of said unit above said junction,

operating a joint comprised in said instrument, for enabling said instrument to be inserted into the main stomach cavity bending said joint in a direction to reach a position of said part of the unit in the esophagus above said junction.

17. (canceled)

19. (canceled)

21-154. -154. (canceled)

156. (canceled)