Apparatus for treating obesity

• US 9,681,874 B2
• Filed: 01/29/2009
• Issued: 06/20/2017
• 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): Miles, Jonathan
• Assistant Examiner(s): OBU, KENDRA NNEAMAKA
• Application Number:
  US12/864,708
• Publication Number:
  US 20110009896A1
• Time in Patent Office: 3,064 Days
• 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

An 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. Furthermore including a stretching device to stretch a portion of the stomach wall to further affecting the patient'"'"'s appetite.

Claims

1. A non-energized apparatus for treating obesity of a patient, the apparatus comprising:

an inflatable volume filling device adapted to be at least substantially invaginated by a stomach wall of the patient, wherein the inflatable volume filling device comprises a valve adapted to function as a pump by receiving stomach contractions, for pumping a fluid out from the inflatable volume filling device,

an inflatable adjustable stretching device adapted to be at least substantially invaginated by the stomach wall of the patient; and

a fluid connection device adapted to interconnect the inflatable volume filling device and the inflatable adjustable stretching device to move the fluid from the inflatable volume filling device, by the stomach wall compressing the inflatable volume filling device, to inflate the inflatable adjustable stretching device for actively stretching the stomach wall, for increasing a feeling of satiety.

2. The apparatus according to claim 1, wherein the fluid connection device comprises a first fluid tube interconnected between the inflatable volume filling device and the inflatable adjustable stretching device, causing a fluid connection.

3. The apparatus according to claim 2, wherein the fluid connection device is a first fluid connection device and the apparatus further comprises a second fluid connection device arranged between the inflatable volume filling device and the inflatable adjustable stretching device, wherein the second fluid connection device is dimensioned to allow the pressure in the inflatable volume filling device and the inflatable adjustable stretching device to return to equilibrium after a predetermined time after fluid has been moved into the inflatable adjustable stretching device by means of the first fluid connection device, and wherein the second fluid connection device has a substantially smaller area than the first fluid connection device.

4. The apparatus according to claim 3, wherein the predetermined time is between 1 and 5 hours.

5. The apparatus according to claim 1, comprising a non-return valve arranged in the fluid connecting device to allow movement of the fluid from the inflatable volume filling device to the inflatable adjustable stretching device.

6. The apparatus according to claim 1, wherein the inflatable adjustable stretching device is at least one of;

invaginated in the stomach wall, and substantially smaller than the inflatable volume filling device.

7. The apparatus according to claim 1, comprising an injection port, connected to at least one of the inflatable volume filling device and the inflatable adjustable stretching device to allow calibration of the fluid volume therein.

8. The apparatus according to claim 1, comprising an adjustment reservoir, provided subcutaneously below the patient'"'"'s skin for adjusting the amount of fluid in at least one of;

the inflatable adjustable stretching device and the inflatable volume filling device.

9. The apparatus according to claim 8, wherein adjustment reservoir is adapted to stretch the stretching device by moving fluid from the subcutaneous reservoir to the inflatable adjustable stretching device to expand the stretching device to stretch the stomach wall to create satiety.

10. The apparatus according to claim 1, wherein at least one of the inflatable volume filling device and the inflatable adjustable stretching device comprises an expandable structure comprising a bellows adapted to take into account the fibrosis surrounding the device when implanted, such that the movement of the bellows is substantially un-affected of said fibrosis.

11. The apparatus according to claim 1, wherein the apparatus comprises at least one of:

a. at least one layer comprising a material selected from a group consisting of;

metal, silicon, PTFE, Polyurethane, Teflon®

, or a combination of any of metal, silicon, PTFE, Polyurethane and Teflon; and

b. at least one coating, comprising a coating selected from a group consisting of;

Parylene coating, Polytetrafluoroethylene coating, Polyurethane coating, and Multi-layer coating.

12. The apparatus according to claim 1, wherein the inflatable volume filling device has a volume of between 0.00001 and 0.0002 m³.

13. The apparatus according to claim 1, wherein the inflatable volume filling device has varying circumference to be better adapted to be kept in place invaginated in the stomach wall of the patient.

14. A method for treating obesity, using an apparatus according to claim 1, the method comprising a gastroscopic surgical procedure comprising the steps of;

inserting an instrument/gastroscope into the stomach of a patient,

penetrating the stomach wall by the instrument, an insert in the instrument or a separate second instrument,

inserting the instrument into a hole created in the stomach wall,

expanding a part of the instrument, the insert in the instrument or the separate second instrument being made outside of the stomach wall after the instrument has been inserted into the hole created in the stomach wall,

pulling the expanded part backwards to create a pouch in the stomach wall,

closing the pouch by suturing or stapling or closing by another fixation device,

inserting an inflatable volume filling device and an inflatable adjustable stretching device being in fluid connection with the volume filling device, through the instrument or the separate second instrument, into the pouch,

decreasing the expanded part of the instrument,

withdrawing the instrument or the separate second instrument from the pouch,

expanding the volume filling or stretching device by self-expansion or injecting fluid, and

regulating, calibrating or calibrating and regulating postoperatively the stretching device manually noninvasively or automatically using an implanted internal control unit and sensor inputs, for stretching the stomach wall of the patient.

15. The method according to claim 14, wherein the pouch is formed in the stomach fundus wall.

17. The apparatus according to claim 1 or 16, wherein the inflatable volume filling device has an elongated shape.

18. The apparatus according to claim 1 or 16, wherein the fluid is liquid polyurethane.

19. The apparatus according to claim 1 or 16, wherein the inflatable volume filling device and/or inflatable adjustable stretching device is adapted to be kept in place by stomach-to-stomach tissue sutures or staples.

20. The apparatus according to claim 1 or 16, wherein the inflatable volume filling device has a non-uniform circumference for keeping the inflatable volume filling device in place when invaginated.

16. A non-energized apparatus for treating obesity of a patient, the apparatus comprising:

an inflatable volume filling device adapted to be at least substantially invaginated by a stomach wall of the patient, wherein the inflatable volume filling device comprises a valve adapted to function as a pump by receiving stomach contractions, for pumping a fluid out from the inflatable volume filling device,

an inflatable adjustable stretching device adapted to be at least substantially invaginated by the stomach wall of the patient; and

a fluid connection device adapted to interconnect the inflatable volume filling device and the inflatable adjustable stretching device to move the fluid from the inflatable volume filling device, by the stomach wall compressing the inflatable volume filling device, to inflate the inflatable adjustable stretching device, whilst keeping a volume of the apparatus constant, for actively stretching the stomach wall for increasing a feeling of satiety, wherein the movement of the fluid from the inflatable volume filling device to the inflatable adjustable stretching device causes inflation of the inflatable adjustable stretching device and deflation of the inflatable volume filling device.