Artificial stomach

• US 8,579,987 B2
• Filed: 10/12/2009
• Issued: 11/12/2013
• Est. Priority Date: 10/10/2008
• 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:
  US13/122,809
• Publication Number:
  US 20110196505A1
• Time in Patent Office: 1,492 Days
• Field of Search: 623 2365- 237
• US Class Current: 623/23.65
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• 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 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures

Abstract

An artificial stomach for replacing the normal stomach of a patient comprises a food reservoir adapted to collect food, an inlet connected to a first opening of the food reservoir and further being adapted to upstream connect to the patient'"'"'s gastrointestinal tract, and an outlet connected to a second opening of the food reservoir and further being adapted to downstream connect to the patient'"'"'s gastrointestinal tract.

Claims

1. An artificial stomach for replacing the normal stomach of a patient comprising:

a food reservoir adapted to collect food,

an inlet connected to a first opening of the food reservoir and further being adapted to upstream connect to at least one of;

the patient'"'"'s esophagus and intestine, and

an outlet connected to a second opening of the food reservoir and further being adapted to downstream connect to the patient'"'"'s gastrointestinal tract,

a servo reservoir for regulating the size of the food reservoir,

wherein an outer wall encloses both the food reservoir and the servo reservoir the food reservoir and the servo reservoir being separated by a flexible inner wall, and

wherein both a wall of the food reservoir and a wall of the servo reservoir comprise parts of the outer wall and the flexible inner wall.

2. The artificial stomach according to claim 1, wherein the servo reservoir is a bellow.

3. The artificial stomach according to claim 1, wherein emptying of the food reservoir is directly or indirectly regulated by a gear construction driven by a motor, and wherein the artificial stomach further comprises a servo system connected to the motor, to save force against longer strokes.

5. The artificial stomach according to claim 1, wherein the servo reservoir is adapted to have a variable size and to be filled with different amounts of fluid, and wherein the servo reservoir is further adapted to have a shape allowing variation in size without limitation from surrounded fibrosis, covering the implant when implanted.

6. The artificial stomach according to claim 5, further comprising a hydraulic fluid reservoir, hydraulically connected to said servo reservoir and a pump for fluid connecting the hydraulic fluid reservoir to the servo reservoir, wherein the food reservoir is adapted to increase in volume when filled with food when the patient is eating, thereby causing a reduction in the volume of the servo reservoir, in turn, moving fluid from the servo reservoir to the hydraulic fluid reservoir, and wherein the pump for fluid connecting the hydraulic fluid reservoir to the servo reservoir is adapted to move liquid from the hydraulic fluid reservoir to the servo reservoir or reversibly move fluid between the servo reservoir and the hydraulic fluid reservoir.

7. The artificial stomach according to claim 5, wherein said servo reservoir is adapted to be regulated by manually pressing a pumping reservoir in fluid connection with the servo reservoir.

8. The artificial stomach according to claim 1, wherein the outer wall is substantially rigid, the stomach food part comprises the food reservoir and the servo reservoir, the hydraulic fluid reservoir is separated from the stomach food part by the rigid outer wall and is further enclosed by a fluid reservoir wall, and the artificial stomach is adapted to he implanted in the patient'"'"'s abdomen.

9. The artificial stomach according to claim 8, wherein said food reservoir is adapted to increase in volume when filled with food when the patient is eating, thereby causing a reduction in the volume of the servo reservoir, in turn moving fluid from said servo reservoir to said hydraulic fluid reservoir.

10. The artificial stomach according to claim 1, wherein the outlet is further adapted to downstream connect to the intestine, the artificial stomach further comprising:

an inlet valve adapted to be connected between the patient'"'"'s gastrointestinal tract and the inlet connected to the first opening of the food reservoir, wherein at least one of;

the inlet valve is adapted to open correlated to when food in the gastrointestinal tract upstream is transported down,

the inlet valve is adapted to open correlated to when a contracting wave is propagating along the gastrointestinal tract upstream, and

the inlet valve is adapted to open correlated to when food is reaching the inlet valve, and

an outlet valve connected between the second opening of the food reservoir and the outlet, wherein at least one of;

the outlet valve is adapted to open when the food reservoir should be emptied,

the outlet valve is adapted to open at a regulated rate, the food reservoir is adapted to empty open step by step, small portions at a time, and

the outlet valve is adapted to functioning passively and opens related to a volume decrease in the food reservoir.

11. The artificial stomach according to claim 1, wherein the artificial stomach further comprises an inlet valve unit comprising an inlet valve and a burp output, and wherein the burp output further comprises a burp valve connecting the food reservoir with the inlet valve proximal to said burp valve.

12. The artificial stomach according to claim 1 further comprising at least one connector, the at least one connector being adapted to upstream connect the inlet to the patient'"'"'s gastrointestinal tract, and/or downstream connect the outlet to the patient'"'"'s gastrointestinal tract, wherein the connector comprises at least one of:

a conduit fixedly attached at a first, proximal end on the outside the artificial stomach and in fluid connection to the food passageway, where a proximal part of the conduit is formed like a tube, and distal to the tube a bulge is formed, and a blocking ring arranged to be pushed against the bulge, the ring having an inner diameter less than the outer diameter of the bulge but large enough to allow an intestinal/oesophageal wall to be placed between the ring and the tube, so as to thereby be adapted to stop the intestinal/oesophageal wall from slipping away from the tube,

wherein the blocking ring is arranged to be pushed over a flexible sleeve or the intestine against the bulge, thereby being adapted to stop the intestinal/oesophageal wall from slipping away from the tube, and

a sleeve adapted to cover a part of a wall of the gastrointestinal tract, wherein the sleeve has a structure adapted to promote in-growth of human tissue into the sleeve, wherein the flexible sleeve is arranged to at least one of;

cover a part of the wall of the gastrointestinal tract, and to be rolled upon itself and then unrolled to cover part of the tube and the oesophagus or intestine, which is arranged to be pulled over the second end of the conduit sufficiently far so as to extend also over the bulge.

13. The artificial stomach according to claim 1, further comprising at least one of a food handling system and a cleaning system,

the food handling being adapted to at least one of:

mechanically handle food in the food reservoir,

move the food around in the food reservoir,

cut food in the food reservoir using electrically driven rotating knifes,

squeeze food in the food reservoir,

chemically handle food in the food reservoir, and

release at least one liquid in the food reservoir, the liquid being adapted to treat the food in the food reservoir, and

the cleaning system being adapted to clean the surface of the food reservoir by releasing at least one liquid into the food reservoir.

14. The artificial stomach according to claim 13, further comprising a special container,

wherein the special container is adapted to accumulate and distribute at least one of:

liquid to the food handling system, and liquid to the cleaning system, and

wherein the liquid to the food handling system comprises at least one of;

an acid, an enzyme, and an anti-bacterial substance,

wherein the liquid to the cleaning system comprises at least one of;

a cleaning substance, and an anti-bacterial substance,

and wherein the artificial stomach further comprises at least one injection port adapted to be placed subcutaneously in the patient and connected to the artificial stomach and adapted to be injected with at least one liquid selected from a set of;

a liquid comprising an anti-bacterial substance, an acid, a liquid comprising a cleaning substance, and a liquid visible on x-ray.

15. The artificial stomach according to claim 6, wherein at least one of said food reservoir, a servo reservoir for controlling the food reservoir and a hydraulic fluid supply reservoir for controlling the servo reservoir, of said artificial stomach is provided with at least one layer that is an inner layer or an outer layer comprising at least one:

a Parylene layer,

a polytetrafluoroethylene layer,

a polyurethane layer,

a silicon layer,

a metal layer, and

a metal layer comprising at least one of;

gold, silver, and titanium, or a combination thereof.

16. The artificial stomach according to claim 1, wherein moving of fluid from the servo reservoir to the hydraulic fluid reservoir is done by that at least one of:

food entering the food reservoir from the inlet pressing on the flexible wall of the servo reservoir, thus emptying fluid from the servo reservoir to the hydraulic fluid reservoir via a return conduit, wherein the return conduit is arranged between the hydraulic fluid reservoir and the servo reservoir for moving fluid between the servo reservoir and the hydraulic fluid reservoir via the return conduit, and

a food sensor sending signals to the pump when food enters the food reservoir, the pump pumping out to the food a corresponding amount of fluid from the servo reservoir to the hydraulic fluid reservoir.

17. The artificial stomach according to claim 1 being adapted to regulate the artificial stomach postoperatively to slowly, step by step, empty food in the artificial stomach into the intestine, and being adapted to fill the servo reservoir with fluid, step by step, in small steps so that the food reservoir is emptied or at least essentially emptied in small steps which results in food being received by the intestine in small subsequent portions.

18. The artificial stomach according to claim 1 further comprising a fastening device for the artificial stomach, adapted to at least one of:

be fastening the artificial stomach,

be fastened by using screws, rivets or another kind of fastener,

be made of elastic material to adapt to movements of the patient,

be divided in first and second units,

be interconnected between divided first and second units of the fastening device by an interconnecting device,

be placed in the abdomen,

be placed in the thorax,

be placed subcutaneously,

be placed in the abdominal wall, and

be placed by a muscle fascia.

19. The artificial stomach according to claim 1 further comprising an operation device for operating the artificial stomach, wherein the operation device comprises at least one of:

a motor,

a pump,

an electrically operated operation device,

an electric motor, and

a hydraulic operation device, and

wherein the artificial stomach further comprises at least one of;

an internal energy source comprising a battery to power the operation device,

an internal energy source comprising an accumulator to power the operation device,

a remote control,

a receiver for receiving signals from a remote control, and

a subcutaneous switch for non-invasively regulating a function of the artificial stomach.

20. A system including the artificial stomach according to claim 1, comprising an energy source adapted to power the artificial stomach, wherein the energy source comprises at least one of:

an internal energy source,

an internal energy source adapted to be charged by energy in a wireless mode to receive energy from an external energy source transmitting energy in a wireless mode,

a wireless energy transmitter adapted to non-invasively energize the internal energy source,

a wireless energy transmitter adapted to non-invasively energize the artificial stomach,

an energy-transforming device to transform wireless energy from a first form into a second form energy,

an energy-transforming device for transforming wireless energy from a first form into a second form energy, adapted to directly during energy transfer operate the artificial stomach with a second form energy, and

wirelessly transmitted energy, first form energy, to directly in its wireless form affect the operation device to create kinetic energy to adjust the device during energy transfer.

21. The system according to claim 20, comprising a sensor arranged to sense a functional parameter of the artificial stomach or a physical parameter of the patient.

22. The system according to claim 21, comprising a feed back device and an internal control unit, wherein the internal control unit is acting in response to the physical parameter or functional parameter sensed by the sensor to control the artificial stomach, wherein the sensor is arranged to register at least one of:

parameters relating to the powering of the artificial stomach or the system,

when food is arriving to the artificial stomach, and

that food is arriving to the artificial stomach by registering a change in volume of the oesophagus or a change of the curvature or elongation of the oesophagus wall, when the sensor is arranged on or at the oesophagus wall.

4. An artificial stomach for replacing the normal stomach of a patient comprising:

a food reservoir adapted to collect food,

an inlet connected to a first opening of the food reservoir and further being adapted to upstream connect to the patient'"'"'s gastrointestinal tract,

an outlet connected to a second opening of the food reservoir and further being adapted to downstream connect to the patient'"'"'s gastrointestinal tract,

a servo reservoir for regulating the size of the food reservoir,

an outer wall enclosing both the food reservoir and the servo reservoir, the food reservoir and the servo reservoir being separated by a flexible inner wall, both a wall of the food reservoir wall and a wall of the servo reservoir comprising parts of the outer wall and the flexible inner wall,

wherein emptying of the food reservoir is directly or indirectly regulated by a gear construction driven by a motor,

wherein a drive shaft connected to a servo system connected to the motor directly or indirectly affects the emptying of the food reservoir, and

wherein the drive shaft comprises two ends comprising a thread, spiral ridges turning in different directions at the two ends, further comprising a nut placed on the shaft at each end of the drive shaft, the food reservoir comprising two movable walls of said reservoir, wherein said nuts is adapted to be placed onto said moving walls, the motor adapted to change the volume of said food reservoir, when turning said drive shaft placed into said nuts, by moving said movable walls.