Methods and instruments for treating obesity and gastroesophageal reflux disease

• US 9,877,859 B2
• Filed: 01/29/2009
• Issued: 01/30/2018
• 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): Stransky, Katrina
• Application Number:
  US12/864,947
• Publication Number:
  US 20100331614A1
• Time in Patent Office: 3,288 Days
• Field of Search: 606191-199, 606153, 606157, 600 37, 604 9601, 604 26, 604104, 604 9701, 604 9901, 424422, 424423
• 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

The invention relates surgical abdominal methods of treating obesity in a patient by implanting a volume filling device that, when implanted in a patient, reduces the food cavity in size by a volume substantially exceeding the volume of the volume filling device. Also disclosed is a laparoscopic instrument for providing a volume filling device to be invaginated in the stomach wall of a human patient to treat obesity.

Claims

1. An intraluminar method of treating obesity of a patient having a stomach with a food cavity by implanting a volume filling device to reduce the size of the food cavity, the method comprising the steps of:

introducing an instrument into the esophagus and into the stomach of the patient,

introducing the volume filling device into the stomach of the patient,

creating a hole through the stomach wall using the instrument,

pushing, using the instrument or a guiding wire through the hole made in the stomach wall,

guiding, using the instrument or a guiding wire, at least one of a conduit, an electrical lead, or the conduit and the electrical lead, being attached to the volume filling device, out from the stomach into an abdomen, and at least one of;

i. using the instrument, through the esophagus, to place an implantable non-invasive control unit for controlling the size of the volume filling device in the body of the patient,

ii. using the instrument, through the esophagus, to place at least a part of the implantable non-invasive control unit, or at least one of the conduit, the electrical lead, or the conduit and the electrical lead subcutaneously, and

iii. using the instrument, through the esophagus, to assist in the connection of the volume filling device to the implantable non-invasive control unit, or guiding the at least one of a conduit, an electrical lead, or the conduit and the electrical lead to a control unit location, for controlling the size of the volume filling device,

wherein the implantable non-invasive control unit is configured to be operated non-invasively,

creating a pouch made of a stomach wall portion,

closing the pouch by sutures, staples or a fixation device,

placing the volume filling device in the pouch before or after closing the pouch,

and thus, invaginating the volume filling device in the pouch of the stomach wall, such that an outer surface of the volume filling device rests against an inner surface of the stomach wall.

2. The method according to claim 1, wherein the step of placing the volume filling device in the pouch comprises the steps of:

providing intraluminary an injection type syringe for injecting a fluid into the volume filling device comprising an implanted filling body; and

adjusting a volume of said filling body, during or after the operation.

3. The method according to claim 1, wherein the step of placing the control unit comprising the additional steps of;

dissecting a placement area for an energy receiver, and

placing an energy receiver comprising at least one of an energy-transforming device, a battery, and a rechargeable battery, located inside the patient, in one of the following placement areas;

just beneath the patient'"'"'s skin, in the abdomen, thorax, muscle fascia, in the abdominal wall, or subcutaneously, allowing to receive wireless energy in the implanted energy-transforming device transmitted from an external energy-source to either recharge the battery or power any energy consuming part of the non-invasive control unit.

4. The method according to claim 3, further comprising the steps of implanting a powered pump, a powered motor, or a powered motor and pump wherein the volume filling device is inflatable and hydraulically regulated, the method thereby further allowing the steps of;

regulating the volume of the hydraulic volume filling device, by at least one of;

the powered motor and the powered pump, and

powering at least one of the motor and pump using at least one of;

the energy-transforming device, the battery, and the rechargeable battery.

5. The method according to claim 4 further comprising the steps of;

implanting a powered regulation reservoir in the abdomen of the patient, allowing

moving the wall of the regulation reservoir by the motor, and

performing non-invasive regulation of the motor.

6. The method according to claim 3 further comprising the steps of;

arranging a storage of electric energy by the non-invasive control unit received from the implanted energy-transforming device in the rechargeable battery or a accumulator, which supplies energy to the apparatus,

controlling, by the non-invasive control unit, the releasing of electrical energy from at least one of;

the accumulator or the implanted energy-transforming device.

7. The method according to claim 3, further comprising the further step of;

sending feed back information related to a charging process of the energy transforming device or rechargeable battery, and

changing the energy supply in response to the feedback information.

8. The method according to claim 1, wherein the step of invaginating the volume filling device in the pouch comprises the steps of:

inserting an inflatable volume filling device into the pouch in a deflated state, and

inflating the deflated volume filling device to an inflated state.

9. The method according to claim 8, wherein the step of placing the volume filling device in the pouch comprises the steps of:

injecting the volume filling device into the pouch as a fluid adapted to be transformed into solid state, and

curing the fluid adapted to be transformed into solid state.

10. The method according to claim 1, further comprising forming the pouch so that the pouch is at least partly open and exhibits only one opening or two openings and extends non-circumferentially around the stomach.

11. The method according to claim 1, further comprising the step of inflating the stomach with gas.

12. The method according to claim 1, wherein the step of providing the pouch comprises generating a vacuum.

13. The method according to claim 1, further comprising the steps of:

controlling the non-invasive control unit by at least one of;

a wireless remote control,

a manual control using any implanted part operable by the patient'"'"'s hand, and

a press button placed under the skin.

14. The method according to claim 13, further comprising the step of programming the non-invasive control unit from outside the patient'"'"'s body.

15. The method according to claim 1, wherein the step of introducing the volume filling device into the stomach is performed by means of at least one of:

the instrument, the instrument being integrated in a gastroscope, and a dedicated instrument.

16. The method according to claim 1, wherein the step of placing the non-invasive control unit comprises:

placing an electric switch, switching the operation of the apparatus,

controlling the electric switch by at least one of;

regulating the switch of the apparatus by a remote control from outside the patient'"'"'s body contacting the non-invasive control unit, and

regulating the switch of the apparatus non-invasively by manually pressing the subcutaneous switch and sending information from the implanted switch to the non-invasive control unit to perform a certain predetermined performance and reversing the performance when the patient press the switch again, and thereby

switching the operation of the apparatus on and off.

17. The method according to claim 1, wherein the step of invaginating comprises invaginating a plurality of volume filling devices.

18. The method according to claim 1, wherein the volume filling device is inserted into the stomach as separate portions.

19. The method according to claim 1, further comprising the step of connecting an inlet port of the volume filling device adapted to receive a fluid or gel to at least one of:

a gastroscope,

the instrument,

the instrument being integrated in a gastroscope, and

a dedicated gastroscopic instrument.

20. The method according to claim 1, wherein the step of placing the non-invasive control unit comprises the further step of:

cutting the skin of the patient from outside the abdominal wall,

placing the non-invasive control unit at least partly subcutaneously in the patient, and

attaching the conduit or electrical lead to the non-invasive control unit.

21. The method according to claim 1, wherein the step of placing the non-invasive control unit comprises the further step of placing the non-invasive control unit in the abdomen of the patient.

22. The method according to claim 1, wherein the step of placing the non-invasive control unit comprises the further step of placing the non-invasive control unit in the abdomen enclosed in the volume filling device having electronics therein.