Apparatus for treating obesity and reflux disease

• US 10,045,869 B2
• Filed: 01/29/2009
• Issued: 08/14/2018
• 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): Kuhlman, Catherine B
• Assistant Examiner(s): MCBRIDE, SHANNON CANTY
• Application Number:
  US12/865,033
• Publication Number:
  US 20100324362A1
• Time in Patent Office: 3,484 Days
• Field of Search: 600 37
• 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 apparatus for treating obesity and reflux disease of an obese patient has a volume filling device to be invaginated by a stomach wall portion with the outer surface of the volume filling 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. An implantable movement restriction device to be invaginated by the stomach fundus wall has an outer surface to be rested against the stomach wall in a position between the patient'"'"'s diaphragm and the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient'"'"'s stomach towards the patient'"'"'s diaphragm is restricted, to thereby prevent the cardia from sliding through the patient'"'"'s diaphragm opening into the patient'"'"'s thorax.

Claims

1. An apparatus for treating obesity and reflux disease of an obese patient having a stomach with a food cavity being elongated in a proximal to distal direction, defining a stomach length axis extending in a center thereof, the apparatus comprising a combined device comprising:

at least one volume filling device adapted to be placed with an outer surface of the volume filling device resting against an outside of a stomach wall and be at least substantially invaginated by a stomach wall portion of the patient, such that a volume of the food cavity is reduced in size by a volume substantially exceeding a volume of the volume filling device, thereby treating obesity, and

a movement restriction device for treating reflux disease, wherein the combined device is adapted to be invaginated in the stomach wall from an outside of the stomach, thus attaching a portion of an outside of the stomach wall with another portion of an outside of the stomach wall, from the outside of the stomach, wherein the combined device comprises a curvature and wherein the combined device is adapted to be bent towards an esophagus in relation to the stomach length axis, when the combined device is implanted, for filling a volume above a cardia area between a cardia and a diaphragm muscle such that the cardia is prevented from sliding up into a thorax cavity, whereby reflux disease is prevented, and wherein a lower portion of the combined device is elongated and adapted to be placed and invaginated along the stomach length axis, thus, the invaginated lower portion of the combined device being adapted to be tunnelated in a proximal to distal direction in the stomach wall when implanted, thereby further securing and stabilizing the movement restriction device, and wherein the combined device is elongated with a length and a curvature with such a relation to a lower part that it is adapted to deviate from the stomach length axis towards the esophagus, for changing a shape of the stomach when implanted with the lower part invaginated, such that the cardia is prevented from sliding up into the thorax cavity, whereby reflux disease is prevented, wherein the combined device has a total volume of less than 0.0002 m³when implanted and inflated, and wherein

the apparatus further comprises an implantable first control unit and a second control unit for controlling the volume filling device from outside of the patient'"'"'s body, and wherein the second control unit comprises a wireless remote control adapted to send a signal to the implantable first control unit to control the device non-invasively from outside of the patient'"'"'s body.

2. The apparatus according to claim 1, further comprising an implantable fixation device that, when implanted in the patient, is adapted to secure the combined device or the movement restriction device being part of the combined device, to prevent the cardia from sliding up into the thorax, and adapted to secure the movement restriction device, allowing it to make contact directly or indirectly with the diaphragm muscle to prevent such sliding of the cardia through the patient'"'"'s diaphragm.

3. The apparatus according to claim 2, wherein the fixation device comprises a tissue growth-promoting structure adapted to secure a long term attachment of the fixation device to the stomach wall.

4. The apparatus according to claim 3, wherein the tissue growth-promoting structure comprises a net-like structure.

5. The apparatus according to claim 4, wherein the tissue growth-promoting structure further comprises sutures or staples that, when implanted in the patient, are adapted to attach the net-like structure to a fundus stomach wall.

6. The apparatus according to claim 2, wherein the fixation device comprises a first fixation device that, when implanted in the patient, is adapted to attach together portions of a fundus stomach wall that enclose and thus invaginate the combined device including the movement restriction device to secure the movement restriction device in a position to prevent such sliding of the cardia into the thorax.

7. The apparatus according to claim 6, wherein the first fixation device comprises sutures or staples and is adapted to attach together portions of the fundus stomach wall, when implanted in the patient, to invaginate the combined device in the stomach wall, including being adapted to invaginate the movement restriction device in the fundus stomach wall to thereby keep the movement restriction device secured in place.

8. The apparatus according to claim 2, wherein the fixation device, when implanted in a patient with the combined device, is adapted to attach together portions of the stomach wall so at to invaginate the combined device from outside of the patient'"'"'s stomach wall.

9. The apparatus according to claim 2, wherein the fixation device comprises a second fixation device that, when implanted in the patient with the combined device, is adapted to secure, indirectly or directly, the movement restriction device to the esophagus close to the patient'"'"'s angle of His.

10. The apparatus according to claim 9, wherein the second fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, are adapted to secure the movement restriction device, directly or indirectly to a stomach fundus wall and a wall of the patient'"'"'s esophagus to hold the movement restriction device in position.

11. The apparatus according to claim 2, wherein the fixation device comprises a diaphragm fixation device that, when implanted in the patient with the combined device, is adapted to secure, indirectly or directly, the movement restriction device to the patient'"'"'s diaphragm muscle or associated muscles.

12. The apparatus according to claim 11, wherein the diaphragm fixation device is comprised of a plurality of sutures or staples that, when implanted in the patient with the movement restriction device, are adapted to attach the movement restriction device directly or indirectly to a stomach fundus wall and the diaphragm muscle or muscles associated with the diaphragm muscle to hold the movement restriction device in position.

13. The apparatus according to claim 1, wherein the movement restriction device is adapted to be non-adjustable from outside the patient'"'"'s body when implanted in the patient.

14. The apparatus according to claim 1, wherein the elongated combined device comprises a body.

15. The apparatus according to claim 14, wherein the combined device is adapted to accommodate electronics, an energy source, or electronics and an energy source inside the body of the elongated combined device.

16. The apparatus according to claim 1 being adapted to be pushed or pulled through a trocar for laparoscopic use, wherein the movement restriction device, the volume filling device or the combined device comprising at least one of:

a changeable form which allows the combined device to pass through a laparoscopic trocar or a gastroscopic trocar or instrument,

a changeable form which allows the combined device to assume a slender form having a smaller diameter than that of a trocar for laparoscopic use, whereby when changed to said slender form the movement restriction device can be pushed or pulled through the trocar,

at least one holding device adapted to be used for pushing or pulling the combined device through the trocar for laparoscopic use or for moving, placing or fixating the combined device, and

at least two separate pieces adapted to be inserted into a hollow body and further adapted to be put together to form one unitary piece inside the body, thereby allowing the body to pass through the trocar for laparoscopic use.

17. The apparatus according to claim 1, wherein the movement restriction device, the volume filling device or the combined device comprises a body, and wherein the apparatus is adapted to regulate the body'"'"'s size after being implanted in the patient, the body comprising a chamber and at least one of:

an injection port where the chamber of the body is filled with a fluid through the injection port,

a subcutaneously placed reservoir adapted to be connected to the chamber to non-invasively be regulated by manually pressing the subcutaneously placed reservoir from the outside of the patient'"'"'s body, and

an implantable hydraulic reservoir and a pump connected to the hydraulic reservoir adapted to move hydraulic fluid between the hydraulic reservoir and the inflatable chamber to thereby allow non-invasively from the outside of the patient'"'"'s body the patient be able to pump fluid, so as to adjust the amount of hydraulic fluid supplied to the body.

18. The apparatus according to claim 1, wherein the combined device is adapted to be filled with a filling fluid capable of undergoing a curing process to a semi-solid of solid deformable material, after being injected into the combined device after implantation.

19. The apparatus according to claim 1, wherein the movement restriction device, the volume filling device, or the combined device includes at least one of:

an elastic outer wall, a flexible outer wall, a body having rounded contours without sharp edges that would be damaging to the patient'"'"'s stomach wall, a body made of a homogenous material and a body made of a material softer than 15 Shore.

20. The apparatus according to claim 1, wherein the movement restriction device, the volume filling device or the combined device has a varying circumference so as to be better adapted to be kept invaginated in the stomach wall of the patient, wherein the varying circumference of the combined device comprises at least one of the following shapes:

a body having a circumference in cross section, when moving along at least one axis through the body, said axis having two end points, the circumference increases at least two times or decreases at least two times or having a larger circumference at the end points compared to a smallest circumference between the end points, when moving along said axis,

a body having a circumference in cross section, when moving along an axis through the body, that constantly increases or remains constant when moving along the axis from a first end point of said axis to a first intermediate point with a first maximum, that constantly decreases or remains constant when moving from the first intermediate point to a second intermediate point with a first minimum, that constantly increases or remains constant when moving along the axis from the second intermediate point of the axis to a third intermediate point with a second maximum; and

that constantly decreases or remains constant when moving trop the third intermediate point to a second end point of the axis, and

a body having a maximum circumference in cross section, when moving along an axis through the body, that decreases or is constant when moving along the axis, when starting from the maximum circumference and moving in the one or two directions away from the maximum circumference along the axis.

21. The apparatus according to claim 1, comprising an operation device that comprises at least one of:

a motor and a pump, and further comprising a hydraulic reservoir, wherein the hydraulic reservoir is connected to at least one chamber in the volume filling device, and wherein the apparatus is adapted to motive liquid between the hydraulic reservoir and the volume filling device, the hydraulic reservoir having a wall portion partly defining, a volume of the hydraulic reservoir and the volume of the hydraulic reservoir being regulated by at least one of;

moving the wall portion of the wall of the hydraulic reservoir, and pumping liquid between the hydraulic reservoir and the volume filling device using at least one of;

the motor pump.

22. The apparatus according to claim 1, further comprising at least one adjustable stretching device that, when implanted in the patient, is adapted to stretch a part of the patient'"'"'s stomach wall, to thereby treat obesity by affecting the patient'"'"'s appetite.

23. The apparatus according to claim 22, comprising an implantable stretching control unit being adapted to automatically control the adjustable stretching device, when the stretching control unit and stretching device are implanted, to stretch the stomach wall portion in connection with the patient eating such that satiety is created.

24. The apparatus according to claim 1, comprising a sensor adapted to sense a functional parameter of the apparatus, further comprising an internal energy source, wherein at least one functional parameter is correlated to a transfer of wireless energy for charging the internal energy source, and wherein the apparatus further comprises, a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related at least to the functional parameter sensed by the sensor.

25. The apparatus according to claim 24, further comprising an implantable stretching control unit adapted to control the apparatus in response to the sensor sensing the parameter, wherein the sensor is adapted to sense at least one of:

a functional parameter of the apparatus, physical parameter of the patient, and a parameter direct or indirect correlated to a food intake of the patient.

26. The apparatus according to claim 1, wherein at least a wall portion of the movement restriction device, the volume filling device or combined device is provided with at least one of:

at least one coating and at least one layer, wherein at least one layer or at least one coating comprises at least one of;

Parylene, polytetrafluoroethylene, polyurethane, silicon, PTFE, metal and any multilayer combination thereof.

27. The apparatus according to claim 1, wherein the volume filling device or the combined device has a varying circumference adapted to facilitate keeping in place the volume filling device or combined device invaginated in the stomach wall of the patient.

28. The apparatus according to claim 1, wherein the volume filling device or the combined device comprises at least two interconnectable portions adapted to be placed invaginated inside the stomach wall a separate portions.

29. The apparatus according to claim 1, wherein at least one of the volume filling device and movement restriction device, comprises an expandable structure, adapted to expand when the device is invaginated in the stomach wall, wherein said structure comprises a bellows adapted to be substantially un-affected by fibrosis.

30. The apparatus according to claim 1, comprising an energy-transforming device, a battery, a rechargeable battery, or a rechargeable battery and an energy-transforming device, adapted to be placed just beneath the patient'"'"'s skin in an abdomen, thorax, muscle fascia, in an abdominal wall, or subcutaneously, wherein when comprising the energy-transforming device, the energy-transforming device is adapted to receive wireless energy transmitted from an external energy-source to at least one of:

recharge the rechargeable battery or directly power any energy consuming part of the apparatus.

31. The apparatus according to claim 1, comprising a stretching control unit including intelligence in forms of at least one of:

a field-programmable gate array (FPGA), a microcontroller unit (MCU), an application specific integrated circuit (ASIC), a component, a memory, and any other circuit, wherein the stretching control unit is at least one of;

adapted to be programmable from outside the patient'"'"'s body, and

adapted to arrange a storage of electric energy received from wireless energy from outside the body.