OBESITY TREATMENT

• US 20120029550A1
• Filed: 01/29/2010
• Published: 02/02/2012
• 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 10,226,372 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 1/3132 for laparoscopy
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0491 Sewing machines for 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00411 : actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00535 : pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00561 : creating a vacuum
• CPC Class Codes: A61B 2017/00734 : battery operated
• 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 2017/00845 : of moving parts with respect to each other
• CPC Class Codes: A61B 2017/00858 : high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/07235 : containing different staples, e.g. staples of different shapes, sizes or materials
• 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: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 90/02 : Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• 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 5/0086 : using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal
• CPC Class Codes: A61M 2025/1054 : having detachable or disposable balloons
• 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
• CPC Class Codes: H02J 2310/23 : The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 50/10 : using inductive coupling
• CPC Class Codes: H02J 50/80 : involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
• CPC Class Codes: H02J 7/0042 : characterised by the mechanical construction

Abstract

An apparatus for treating obesity comprises a volume filling device formed by at least two segments and is provided and following implantation, the device is placed resting against the stomach wall of the patient to reduce the inner volume of the stomach, thereby affecting the patients appetite.

Claims

1. An apparatus for treating obesity in a human or animal mammal patient, the apparatus comprising:

two or more volume filling device segments adapted to form an implantable volume filling device, wherein the volume filling device is adapted to be at least substantially be invaginated by a stomach wall portion of a patient, wherein said volume filling device is adapted to be placed with the outer surface of the device resting against the stomach wall, such that the volume of the food cavity is reduced in size by a volume substantially exceeding the volume of the volume filling device, when the volume filling device is invaginated in the stomach wall, and wherein said volume filling device is adapted to disassemble into its volume filling device segments if the volume filling device leaves its implanted invaginated stomach position and inadvertently penetrates the stomach wall to become located inside the stomach including penetrating the stomach wall to retain a position inside the stomach, wherein said volume filling device segments are adapted to separately pass through the food passageway, thereby reducing risk for causing obstruction/ileus in the patient'"'"'s intestine.

2. The apparatus according to claim 1, wherein the volume filling device has a minimum circumference of at least 15 millimeters.

3. The apparatus according to claim 1, wherein the volume filling device segments has at least a part of an outer surface including a biocompatible material.

4. The apparatus according to claim 1, wherein the volume filling device segments are adapted to pass through a trocar, for assembly and implantation of said volume filling device into the abdominal cavity.

5. The apparatus according to claim 4, the volume filling device segments have a flexible outer shape adapted to pass through a trocar.

6. The apparatus according to claim 1, wherein the volume filling device segments are adapted to have a shape allowing them to be assembled into said volume filling device, when implanted.

7. The apparatus according to claim 1, wherein the volume filling device segments are hollow with a flexible outer surface.

8. The apparatus according to claim 7, wherein the volume filling device segments are adapted to be filled with at least one of a fluid a foam, a gel or a fluid that hardens to a solid material.

9. The apparatus according to claim 1, wherein the volume filling device segments are solid.

10. The apparatus according to claim 1, wherein the volume filling device segments are adapted to temporary be holding their assembled position.

11. The apparatus according to claim 10, wherein the volume filling device segments are adapted to permanently hold their assembled position by the invaginated stomach wall.

12. The apparatus according to claim 11, wherein the volume filling device segments are adapted to temporary be holding their assembled position by an adhesive.

13. The apparatus according to claim 1, wherein the segments are of size that admits free passage through the gastrointestinal system.

14. The apparatus according claim 1, wherein that each segment is provided with at least one assembly element that sufficiently fits with at least one assembly element of another segment, so the segments by fitting assembly elements can be assembled into the implantable volume filling device.

15. The apparatus according to claim 14, wherein the segments comprise a core part and a plurality of outer parts.

16. The apparatus according to claim 14, wherein the assembly element is selected among sufficiently fitting flanges and slits.

17. The apparatus according to claim 15, wherein the core part is adapted to receive and assemble the outer elements into an implantable volume filling device.

18. The apparatus according to claim 17, wherein the core part has assembly slits adapted to receive corresponding assembly flanges of the outer parts when assembling the volume filling device.

19. The apparatus according to claim 18, wherein the slits are distributed around the outer peripheral area of the core part.

21. The apparatus according to claim 1, wherein the apparatus further comprises a guiding device, operable for assembling the volume filling device segments to an implantable volume filling device.

204. A method of using an apparatus according to claim 1, wherein said method comprises one or more of the following operational method steps:

introducing an 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,

a 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.

206. A method of using an apparatus 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.

20. (canceled)

22-203. -203. (canceled)

205. (canceled)