Device for treating obesity

• US 8,636,809 B2
• Filed: 01/29/2009
• Issued: 01/28/2014
• 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): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/864,836
• Publication Number:
  US 20100332000A1
• Time in Patent Office: 1,825 Days
• Field of Search: 606/191, 607/40, 623 2364- 237, 600/37
• 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

A device for treating obesity of a patient, the device comprising: at least one operable stretching device implantable in the patient and adapted to stretch a portion of the patient'"'"'s stomach wall, and an implantable control unit for automatically controlling the operable stretching device, when the control unit and stretching device are implanted, to stretch the stomach wall portion in connection with the patient eating such that satiety is created.

Claims

1. A device for treating obesity of a patient, the device comprising:

at least one operable stretching device implantable in the patient for stretching a portion of the patient'"'"'s stomach wall, and

an implantable control unit for automatically controlling the operable stretching device to stretch the stomach wall portion of the patient'"'"'s stomach wall in connection with the patient eating such that satiety is created, when the control unit and stretching device are implanted in the patient and the patient is eating,

wherein the stretching device is adapted to stretch a stomach wall portion controlling;

force used for stretching the stomach wall portion as well as,

time periods the stretching is applied, and

when the stretching is applied,

wherein the stretching device further is adapted to at least one of;

being engaged with a part of the stomach wall, including at least one of;

suturing or stapling the stretching device to the stomach wall and invaginating the stretching device in the stomach wall, with stomach to stomach sutures or staplers,

comprising two parts engaged with different parts of the stomach wall, one part each, wherein said engagement includes suturing or stapling the parts to the stomach wall or invaginating the parts in the stomach wall part, with stomach to stomach sutures or staplers,

wherein the stretching device is further adapted to have different wall portions stretched independently from each other,

comprising three or more hydraulic parts engaged with different parts of the stomach wall, one part each, wherein said engagement includes suturing or stapling tele hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures or staplers, wherein the three or more hydraulic parts are adapted to independently of each other stretch three different wall portions, the stretching device further being adapted to having said wall portions stretched independently from each other, and

comprising three or more mechanical parts engaged with different parts of the stomach wall, one part each, wherein said engagement includes suturing or stapling to the stomach wall or invaginating the mechanical parts in the stomach wall part with stomach to stomach sutures or staplers, wherein the three or more mechanical parts are adapted to move in relation to each other and adapted to stretch three different wall portions, the stretching device further being adapted to having said wall portions stretched independently from each other.

2. The device according to claim 1, further comprising an operation device for operating the stretching device, wherein the control unit controls the operation device to stretch the stomach wall portion, when the control unit and stretching device are implanted.

3. The device according to claim 1, further comprising a sensing device including a sensor for sensing a physical parameter of the patient or a functional parameter of the stretching device, wherein the sensing device sends information relating to the parameter to the control unit, and the control unit controls the stretching device based on the information.

4. The device according to claim 1, wherein the implantable control unit, when the control unit and stretching device are implanted, is adapted to control at least one of:

the stretching device to intermittently stretch the stomach wall,

the amount of stretching performed by the stretching device on the stomach wall,

the stretching device to vary over time the amount of stretching of the stomach wall,

the stretching device to stretch the stomach wall during a predetermined time period, and

the stretching device based on the patient'"'"'s food intake.

5. The device according to claim 1, wherein the implantable control unit is programmable to include any of:

a) predetermined time period during which the stretching device is controlled to stretch the stomach wall, and

b) the magnitude of stretching applied on the stomach wall.

6. The device according to claim 2, wherein the operation device is at least one of a mechanical operation device, a hydraulic operation device, a hydraulically operated mechanical operation device, and a mechanically operated hydraulic operation device.

7. The device according to claim 3, wherein the sensor of the sensing device senses the patient'"'"'s food intake directly or indirectly, and the implantable control unit controls the operation device to stretch the stomach wall in response to signals from the sensor.

8. The device according to claim 1, further comprising two or more stretching devices, wherein the implantable control unit is adapted to control the operation device to stretch the stomach wall using more than one stretching device.

9. The device according to claim 8, wherein the implantable control unit is adapted to control;

a) the first stretching device, during a first time period, to stretch a first portion of the stomach wall, and b) at least the second stretching device, during a second time period, to stretch a second portion of the stomach wall different from said first portion of the stomach, to allow longer relaxation of the stomach wall in between stretching periods.

10. The device according to claim 1, wherein the stretching device comprises a first and a second engaging part, wherein:

the first part is adapted to be engaged to a first area of the stomach wall, and

the second part is adapted to be engaged to a second area of the stomach wall, and wherein the stretching device is adapted to stretch a portion of the stomach wall between the first area and the second area.

11. The device according to claim 1, comprising three or more stretching devices, wherein the control unit individually controls the three or more stretching devices from time to time to stretch one or more portions of the stomach wall, to achieve satiety.

12. The device according to claim 1, wherein the device further comprises an energy source to power the device comprising at least one of:

a wireless energy receiver for non-invasively energizing the device with wireless energy,

an internal energy source, and

an internal energy source adapted to receive energy from an external energy source in a wireless mode.

13. The device according to claim 3, wherein the parameter is a parameter selected from a group consisting of:

contraction and relaxation of the Cardia or esophagus, esophagus movement, esophagus bending, esophagus motility, esophagus stretching, esophagus pressure, food passing esophagus, food in the stomach, neural activity, vagus activity, muscle activity, hormonal activity, stomach motility, stomach stretching, stomach pressure, stomach bending, stomach filling, and acidity in the stomach, capacitance, resistance, volt, ampere, light absorption or visualization, ultrasound reflection or absorption, bending metal, bimetal and PH.

14. The device according to claim 1, wherein the device further comprises an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator is adapted to feed data related to the device for treating obesity or the patient back to the external data communicator or the external data communicator feeds data to the internal data communicator.

15. The device according to claim 2, wherein the operating device comprises an operating device selected from a list consisting of at least one of;

a mechanically, a hydraulically, a pneumatic construction, a motor or pump, moving material changing form when powered, and a construction using manual force.

16. The device according to claim 3, wherein the sensor is a sensor correlated to the food intake of the patient.

17. The device according to claim 1, wherein the stretching device is provided with a coating, wherein the coating is at least one of:

a Parylene coating, a polytetrafluoroethylene coating, a polyurethane coating, a metal coating or a combination of the coating in a multi-layer coating construction.

18. The device according to claim 1, wherein the stretching device comprises an expandable structure, adapted to expand and stretch the stomach wall portion, when the device is invaginated in the stomach wall, and wherein said structure comprises a special bellow adapted to take into account the fibrosis surrounding the device when implanted, such that the movement of the bellow is substantially un-affected by said fibrosis.

19. The device according to claim 1, wherein the stretching device further is adapted to be engaged with a part of the stomach wall, including at least one of:

suturing or stapling the stretching device to the stomach wall and invaginating the stretching device in the stomach wall, with stomach to stomach sutures.

20. The device according to claim 1, further adapted to indirectly control the force using a sensor sensing at least one of:

a pressure, a stomach pressure, a esophagus pressure, a movement, a stretching, and a stomach stretching.

21. The device according to claim 1, comprising a sensor or sensing device adapted to sense a parameter related to the patients food intake, relating to when the stretching should be applied.